Common use of INFORMATION INCORPORATED BY REFERENCE Clause in Contracts

INFORMATION INCORPORATED BY REFERENCE. We are incorporating by reference into this prospectus supplement and the accompanying prospectus certain information that we file with the SEC, which means that we are disclosing important information to you by referring you to those documents. The information incorporated by reference is deemed to be part of this prospectus supplement and the accompanying prospectus, except for information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: • our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports on Form 8-K filed with the SEC on March 10, 2020 and July 6, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement until the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, without charge upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including exhibits which are specifically incorporated by reference into such documents. You may request a copy of these filings at no cost, by writing to or telephoning us at the following address: We may from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: At the Market Offering Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating by reference into this This prospectus supplement and the accompanying prospectus certain are part of a registration statement that we have filed with the SEC. The SEC allows us to “incorporate by reference” the information that we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those documents. The information incorporated by reference is deemed considered to be part of this prospectus supplement and the accompanying prospectus, except for information incorporated by reference prospectus from the date we file that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: • our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports on Form 8-K filed with the SEC on March 10, 2020 and July 6, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019document. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section us under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act with the SEC (including those portions of our Definitive Proxy Statement on Schedule 14A, as filed with the SEC, specifically incorporated by reference in our Annual Report on Form 10-K or amendments thereto); after the date of this prospectus supplement until and before the termination date that the offering of shares by means of this prospectus supplement and accompanying prospectus is terminated will automatically update and, where applicable, supersede any information contained or incorporated by reference in this prospectus supplement and accompanying prospectus. We incorporate by reference into this prospectus supplement and the offeringaccompanying prospectus the following documents or information filed with the SEC (other than, in each case, documents or information deemed to have been furnished and not filed in accordance with SEC rules): · Our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 8, 2021, as amended by Amendment No. These documents include periodic reports, such as 1 to our Annual Reports Report on Form 10-K, Quarterly Reports as filed with the SEC on March 29, 2021 (including those portions of our Definitive Proxy Statement on Schedule 14A, as filed with the SEC, specifically incorporated by reference in our Annual Report on Form 10-Q and K or amendments thereto); · Our Current Reports on Form 8-K filed with the SEC on February 9, 2021, February 12, 2021, March 9, 2021 and March 24, 2021; and · the description of our capital stock contained in our Information Statement, filed as Exhibit 99.1 to Amendment No. 4 to our Registration Statement on Form 10 (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwiseFile No. 001-36876), as well as filed on June 9, 2015, including any proxy statementsamendment or report filed for the purpose of updating such description. We will provide without charge to each person, including any beneficial owner, to whom a this prospectus supplement and the accompanying prospectus are delivered, without charge upon his or her written or oral request, a copy of any or all of the documents referred to above that are have been or may be incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including excluding exhibits which to those documents unless they are specifically incorporated by reference into such those documents. You may request a copy of these filings at no cost, those documents from us by writing to or telephoning contacting us at the following address: We are currently subject to the information requirements of the Exchange Act, and in accordance therewith file periodic reports, proxy statements and other information with the SEC. Our filings with the SEC are available to the public from the SEC’s website at ▇▇▇.▇▇▇.▇▇▇. In addition, our common stock is listed on the NYSE, and our reports and other information can be inspected at the offices of the NYSE, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇. We maintain a website at ▇▇▇.▇▇▇▇▇▇▇.▇▇▇. The information on our website is not part of or incorporated by reference in this prospectus supplement or the accompanying prospectus. Prospectus We may offer and sell from time to time offer and sell up to our debt securities in one or more offerings with an aggregate initial offering price of $125,000,000 of common stock, preferred stock, warrants to purchase common stock 150,000,000 or preferred stock the equivalent amount in other currencies or any combination currency units. We will provide the specific terms of the foregoing, either individually or in units, at prices and on terms described securities to be offered in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced supplement carefully before you invest in this prospectusour securities. This prospectus may not be used to consummate offer and sell our securities unless accompanied by a prospectus supplement describing the method and terms of the offering of those securities. We may sell securities directly or to or through underwriters or dealers, and also to other purchasers or through agents. The names of any underwriters or agents that are included in a sale of securities unless accompanied by the to you, and any applicable commissions or discounts, will be stated in an accompanying prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market New York Stock Exchange under the symbol “BPTH.BWand our 8.125% senior notes due 2026 are listed under the New York Stock Exchange under the symbol “BWSN”. None of the other securities that we may offer under this prospectus are currently publicly traded. On May 14March 8, 20192021, the last reported sales closing price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination 6.76 per share and the closing price of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discountsour 8.125% senior notes due 2026 was $25.64 per Note. The price to the public date of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectusprospectus is , 2021. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 Table of Contents Page This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (Commission, or the SEC”) , using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or securities described in units, this prospectus in one or more offerings up to an aggregate initial offering amount price of $125,000,000150,000,000 or the equivalent amount in other currencies or currency units. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offeredoffer. Each time we offer securities hereundersell securities, we will provide a prospectus supplement that will contain specific information about the terms related of that offering. For a more complete understanding of the offering of the securities, you should refer to such offering in the registration statement of which this prospectus forms a supplement to this prospectuspart, including its exhibits. The prospectus supplements supplement may also add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to You should read carefully both this prospectus and the applicable any prospectus supplement, supplement together with the additional information incorporated herein by reference as described referenced under the sections titled headings “Where You Can Find More Information” and “Information Incorporated by We Incorporate By Reference.below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different informationinformation from the information contained or incorporated by reference in this prospectus and in any prospectus supplement or free writing prospectus that we may provide you. No dealer, salesperson or other person is authorized to give any You should not assume that the information or to represent anything not contained in this prospectus or the applicable prospectus, any prospectus supplement. You must not rely on , any unauthorized information or representation. This prospectus document incorporated by reference or any applicable supplement to this free writing prospectus do not constitute an offer to sell or the solicitation is accurate as of an offer to buy any securities date, other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer date mentioned on the cover page of these documents. We are not making offers to sell or the solicitation of an offer to buy securities in any jurisdiction in which an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to any person do so or to anyone to whom it is unlawful to make such an offer or solicitation in such jurisdictionsolicitation. You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information Unless we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed otherwise state or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwiseotherwise indicates, all references in this prospectus to “weB&W,” the ourCompany,” “us,” “the Companyour,and or Bio-Pathwerefer to Bio-Path Holdingsor similar references, Inc. and its wholly-owned subsidiary. Bio-Path Holdingsmean ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ Enterprises, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to “incorporate by reference into this prospectus supplement and reference” the accompanying prospectus certain information that we file with the SEC, them which means that we are disclosing can disclose important information to you by referring you to those documentsdocuments instead of having to repeat the information in this prospectus supplement and the accompanying prospectus. The information incorporated by reference is deemed considered to be part of this prospectus supplement and the accompanying prospectus, except for and later information that we file with the SEC will automatically update and supersede this information. Any statement contained in a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that is superseded by information a statement contained in this prospectus supplement and the accompanying prospectusmodifies or replaces that statement. This means that you must look at all of the SEC filings that we We incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth listed below and any future information filed (rather than furnished) with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act between the date of this prospectus and the termination of this offering, provided, however, that we have previously filed with the SECare not incorporating any information furnished under Item 2.02 or Item 7.01 of any current report on Form 8-K: • our Annual Report on Form 10-K for the fiscal year ended December 31, 20192020, filed with the SEC on March 1, 2021; • the information specifically incorporated by reference into our Annual Report on Form10-K for the year ended December 31, 2020, from our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2021; • our Quarterly Report on Form 10-Q for filed with the quarter ended March 31SEC on May 7, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 20192021; • our Current Reports Report on Form 8-K filed with the SEC on March 10February 3 , 2020 February 9, and July 6February 18, 20202021; and • the description of our common stock Common Stock contained in Exhibit 4.17 to our Annual Report Registration Statement on Form 108-K A, filed with the SEC on April 19, 2010, including any amendments or reports filed for the fiscal year ended December 31, 2019purpose of updating such description. Any information in any of the foregoing These documents will automatically may also be deemed to be modified or superseded to the extent that information accessed on our website ▇▇▇▇▇.▇▇▇▇▇▇▇.▇▇▇. Except as otherwise specifically incorporated by reference in this prospectus supplement and the accompanying prospectus, information contained in, or in accessible through, our website is not a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date part of this prospectus supplement until and the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsaccompanying prospectus. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, furnish without charge to you, upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectusreference, including exhibits which are specifically incorporated by reference into such documents. You may request a copy of to these filings at no cost, documents by writing to or telephoning us at the following address: Codexis, Inc. ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ We may offer and sell the securities identified above from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisionsofferings. This prospectus provides the you with a general terms description of the securities we may offer and the general manner in which these securities will be offeredsecurities. Each time we offer to and sell securities, we will provide specific terms related to such offers in a supplement to this prospectusprospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The prospectus supplements supplement may also add, update or change information contained in this prospectusprospectus with respect to that offering. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplement, as well supplement before you invest in any of our securities. We may offer and sell the documents incorporated by referenced securities described in this prospectus. This prospectus may not be used and any prospectus supplement to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14or through one or more underwriters, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through dealers and agents, dealers or underwriters as designated from time directly to timepurchasers, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agentsunderwriters, dealers or underwriters agents are involved in the sale of these any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement will set forth supplement. See the names sections of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into entitled “About this prospectusProspectus” and “Plan of Distribution” for more information. We urge you to read carefully No securities may be sold without delivery of this prospectus and the applicable prospectus supplement, together with supplement describing the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” method and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as terms of the date on the front offering of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Informationsuch securities.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Equity Distribution Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference information into this prospectus supplement and the accompanying prospectus certain information that we file with the SEC, which document. This means that we are disclosing can disclose important information to you by referring you to those documentsanother document filed separately with the SEC. The information incorporated by reference is deemed to be an important part of this prospectus supplement and the accompanying prospectus, except for and information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of we file later with the SEC filings that we will automatically update and supersede this information. We incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth listed below and any future filings made with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act made subsequent to the date of this prospectus until the termination of the offering of the securities described in this prospectus (other than information in such filings that was “furnished,” under applicable SEC rules, rather than “filed”). We incorporate by reference the following documents or information that we have previously filed with the SEC: • our Annual Report annual report on Form 10-K for the fiscal year ended December 31, 2019; • our Quarterly Report 2019 filed with the SEC on Form 10-Q for the quarter ended March 3118, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports current reports on Form 8-K filed with the SEC on onFebruary 10, 2020, February 18, 2020, March 1018, 2020 and July 6April 3, 2020 (in each case, except for information contained therein which is furnished rather than filed); • our definitive proxy statement on Schedule 14A filed with the SEC on March 30, 2020, as amended on April 3, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report registration statement onForm S-8 filed with the SEC on Form September 10-K , 2019, including any amendment or report filed for the fiscal year ended December 31, 2019purpose of updating such description. Any information statement contained in any of the foregoing documents this prospectus or contained in a document incorporated or deemed to be incorporated by reference into this prospectus will automatically be deemed to be modified or superseded to the extent that information a statement contained in this prospectus or any subsequently filed supplement to this prospectus, or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement until the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, without charge upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including exhibits which are specifically incorporated by reference into modifies or supersedes such documents. statement You may request a copy of these filings at no cost, by writing to or telephoning us at the following address: We may from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock You should rely only on the information incorporated by reference or preferred stock or any combination of the foregoing, either individually provided in this prospectus or in units, at prices and on terms described in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock We have not authorized anyone else to provide you with different or additional information. An offer of these securities is currently listed not being made in any jurisdiction where the offer or sale is not permitted. You should not assume that the information in this prospectus or any prospectus supplement is accurate as of any date other than the date on the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share front of our common stock on the Nasdaq Capital Market was $18.00those documents. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you does not contain all of the information set forth in the registration statement and the exhibits to the registration statement. For further information with a general description of respect to us and the securities we may offer are offering under this prospectus, we refer you to the registration statement and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in exhibits and schedules filed as a supplement to this prospectus. The prospectus supplements may add, update or change any part of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplementregistration statement. You should rely only on the information we have provided contained in this prospectus or incorporated by reference in this prospectus and the applicable prospectus supplementprospectus. We have not authorized anyone else to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything We are not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute making an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy these securities in any jurisdiction to any person to whom it state where the offer is unlawful to make such offer or solicitation in such jurisdictionnot permitted. You should not assume that the information in this prospectus is accurate only as of any date other than the date on the front page of this prospectus, regardless of the time of delivery of this prospectus or any sale of the securities offered by this prospectus. We file annual, quarterly and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public from commercial document retrieval services and that any over the Internet at the SEC’s website at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇. Copies of certain information we have filed by us with the SEC are also available on our website at ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. Information contained in or accessible through our website does not constitute a part of this prospectus and is not incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiaryprospectus.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: At Market Issuance Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference into this prospectus supplement and the accompanying prospectus certain information that we file with the SECthem, which means that we are disclosing can disclose important information to you by referring you to those documents. The information incorporated by reference is deemed considered to be part of this prospectus supplement supplement, and the accompanying prospectus, except for later information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of filed with the SEC filings that we will update and supersede this information. We incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth listed below that we have previously filed with the SEC, except that information furnished under Item 2.02 or Item 7.01 of our Current Reports on Form 8-K or any other filing where we indicate that such information is being furnished and not filed under the Exchange Act, is not deemed to be filed and not incorporated by reference herein: our Annual Report on Form 10-K for the fiscal year ended December 31, 20192020 as filed with the SEC on February 11, 2021, and amended on March 10, 2021; our Quarterly Report on Form 10-Q for the quarter fiscal quarters ended March 31, 20202021 (as filed on May 13, 2021); • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports on Form 8-K filed with the SEC on January 14, 2021, January 19, 2021, January 20, 2021, January 22, 2021, March 101, 2020 2021, May 24, 2021, and July 6May 28, 20202021; and the description of our common stock contained in the registration statement on Form 8-A as filed with the SEC on February 28, 2005,as updated by Exhibit 4.17 4.1 to our Annual Report on Form 10-K for the fiscal year ended December 312020, 2019. Any information in any of filed with the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such informationSEC on February 11, 2021, and amended on March 10, 2021. We also incorporate by reference all into this prospectus supplement additional documents that we subsequently may file in with the future pursuant to Section SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the completion or termination of the offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information deemed furnished and not filed with the SEC. Any statements contained in a previously filed document incorporated by reference into this prospectus supplement is deemed to be modified or superseded for purposes of this prospectus supplement to the extent that a statement contained in this prospectus supplement, or in a subsequently filed document also incorporated by reference herein, modifies or supersedes that statement. This prospectus supplement may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated by reference in this prospectus supplement. You should rely only on the information incorporated by reference or provided in this prospectus supplement. We have not authorized anyone else to provide you with different information. You should not assume that the information in this prospectus supplement is accurate as of any date other than the date of this prospectus supplement until or the termination date of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, incorporated by reference in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsthis prospectus supplement. We will provide to each person, including any beneficial owner, to whom a this prospectus supplement and accompanying prospectus are is delivered, without charge upon written or oral request, at no cost to the requester, a copy of any or and all of the documents information that are is incorporated by reference into in this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including exhibits which are specifically incorporated by reference into such documentssupplement. You may request a copy of these filings filings, at no costcost to you, by telephoning us at (▇▇▇) ▇▇▇-▇▇▇▇ or by writing to or telephoning us at the following address: You may also access the documents incorporated by reference in this prospectus supplement through our website at ▇▇▇.▇▇▇▇▇.▇▇▇. The reference to our website is an inactive textual reference only and, except for the specific incorporated documents listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus supplement, the accompanying prospectus or the registration statement of which it forms a part. We may from time to time offer and sell up to $125,000,000 75,000,000 in the aggregate of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, at prices and on terms described securities identified above from time to time in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisionsofferings. This prospectus provides the you with a general terms description of the securities we may offer and the general manner in which these securities will be offeredsecurities. Each time we offer to and sell securities, we will provide specific terms related to such offers in a supplement to this prospectusprospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The prospectus supplements supplement may also add, update or change information contained in this prospectusprospectus with respect to that offering. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplement, as well supplement and any related free writing prospectus before you invest in any of our securities. We may offer and sell the documents incorporated by referenced securities described in this prospectus. This prospectus may not be used and any prospectus supplement to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14or through one or more underwriters, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through dealers and agents, dealers or underwriters as designated from time directly to timepurchasers, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agentsunderwriters, dealers or underwriters agents are involved in the sale of these any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement will set forth supplement. See the names sections of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into entitled “About this prospectusProspectus” and “Plan of Distribution” for more information. We urge you to read carefully No securities may be sold without delivery of this prospectus and the applicable prospectus supplement, together with supplement describing the information incorporated herein by reference as described method and terms of the offering of such securities. Our common stock is listed on the NYSE American LLC under the sections titled symbol Where You Can Find More InformationINUV.The last reported sale price of our common stock on February 10, 2021 was $1.84 per share. The aggregate market value of our outstanding common stock held by non-affiliates is $197,790,564.48 based on 118,513,403 shares of common stock outstanding, of which 107,494,872 shares are held by non-affiliates, and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely a per share value of $1.84 based on the information contained in that prospectus supplementclosing price of our common stock on the NYSE American on February 10, 2021. ABOUT THIS PROSPECTUS 3 AVAILABLE INFORMATION 3 OUR COMPANY 4 RISK FACTORS 4 CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS 5 USE OF PROCEEDS 5 DIVIDEND POLICY 5 DESCRIPTION OF CAPITAL STOCK 6 DESCRIPTION OF WARRANTS 7 DESCRIPTION OF UNITS 8 LEGAL OWNERSHIP OF SECURITIES 8 PLAN OF DISTRIBUTION 11 LEGAL MATTERS 12 EXPERTS 12 INFORMATION INCORPORATED BY REFERENCE 12 You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable or in any prospectus supplement. We have not authorized anyone to provide you with information different informationfrom that contained or incorporated by reference in this prospectus or in any prospectus supplement. No dealerThis prospectus and any prospectus supplement is an offer to sell only the securities offered hereby, salesperson but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information contained in this prospectus and in any prospectus supplement is accurate only as of their respective dates and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or other any prospective supplement or any sale of securities. The registration statement, including the exhibits and the documents incorporated herein by reference, can be read on the website of the Securities and Exchange Commission, or “SEC,” or on our corporate website at ▇▇▇.▇▇▇▇▇.▇▇▇ as set forth in this prospectus under the heading “Available Information.” This prospectus is part of a registration statement on Form S-3 that we filed with the SEC utilizing a “shelf” registration, or continuous offering, process. Under the shelf registration process, we may issue and sell any combination of the securities described in this prospectus in one or more offerings with a maximum offering price of up to $75,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities under this shelf registration, we will provide a prospectus supplement that will contain certain specific information about the terms of that offering, including a description of any risks related to the offering, if those terms and risks are not described in this prospectus. A prospectus supplement may also add, update or change information contained in this prospectus. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement, you should rely on the information in the prospectus supplement. The registration statement we filed with the SEC includes exhibits that provide more details on the matters discussed in this prospectus. You should read this prospectus and the related exhibits filed with the SEC and the accompanying prospectus supplement together with additional information described under the headings “Available Information” and “Information Incorporated by Reference” before investing in any of the securities offered. Neither we, nor any agent, underwriter or dealer has authorized any person is authorized to give any information or to represent anything not make any representation other than those contained or incorporated by reference in this prospectus or the prospectus, any applicable prospectus supplement. You must not rely supplement or any related free writing prospectus prepared by or on any unauthorized information behalf of us or representationto which we have referred you. This prospectus or prospectus, any applicable supplement to this prospectus do or any related free writing prospectus does not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do does this prospectus or prospectus, any applicable supplement to this prospectus or any related free writing prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate only as of on any date subsequent to the date set forth on the front of the document and or that any information we have incorporated by reference is accurate only as of correct on any date subsequent to the date of the document incorporated by reference. Our business, financial conditioneven though this prospectus, results of operations and prospects may have changed since those datesany applicable prospectus supplement or any related free writing prospectus is delivered, or securities are sold, on a later date. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled entitled Where You Can Find More Available Information.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference into this prospectus supplement and the accompanying prospectus certain information that we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those documents. The information incorporated by reference is deemed considered to be a part of this prospectus supplement and the accompanying prospectus, except for and information incorporated by reference that is superseded by we file later with the SEC will automatically update and supersede information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously The following documents are incorporated by reference have been modified into this document (other than the portions of these documents deemed to be “furnished” or superseded. This prospectus supplement incorporates by reference not deemed to be “filed,” including the portions of these documents set forth below that we have previously filed are furnished under Item 2.02 or Item 7.01 of a Current Report on Form 8-K, including any exhibits included with the SEC: • our such Items): ● Our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; • our 2023, filed with the SEC on April 1, 2024. ● Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders2024, filed November 1with the SEC on May 14, 2019; • our 2024. ● Our Current Reports on Form 8-K filed with the SEC on March 10January 4, 2020 2024, January 11, 2024, January 24, 2024, February 2, 2024, February 9, 2024, February 13, 2024, February 22, 2024, April 1, 2024, April 19, 2024, April 22, 2024 and July 6April 26, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information2024. We also incorporate by reference into this prospectus supplement all documents we subsequently file in (other than Current Reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items) that are filed by us with the future SEC pursuant to Section Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement and until the completion or termination of the offeringoffering contemplated hereby. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, K. Any statement contained herein or in any such case, the portions furnished and not filed pursuant a document incorporated or deemed to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, without charge upon written or oral request, a copy of any or all of the documents that are be incorporated by reference into this prospectus supplement document will be deemed to be modified or superseded for purposes of the document to the extent that a statement contained in this document or any other subsequently filed document that is deemed to be incorporated by reference into this document modifies or supersedes the statement. We make available, free of charge, through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a), 13(c), 14 or 15(d) of the accompanying prospectus but not delivered with Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the prospectus supplement and accompanying prospectusSEC. You may request, including orally or in writing, a copy of these documents, which will be provided to you at no cost (other than exhibits, unless such exhibits which are specifically incorporated by reference into such documents. You may request a copy of these filings at no costreference), by writing contacting ▇▇▇▇▇ ▇▇▇▇▇, c/o Gryphon Digital Mining, Inc., at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇. Our telephone number is (▇▇▇) ▇▇▇-▇▇▇▇. Information about us is also available at our website at ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. However, the information in our website is not a part of this prospectus supplement and is not incorporated by reference. ● common stock; ● preferred stock; ● warrants to purchase our securities; ● subscription rights to purchase any of the foregoing securities; ● secured or telephoning us at unsecured debt securities consisting of notes, debentures or other evidences of indebtedness which may be senior debt securities, senior subordinated debt securities or subordinated debt securities, each of which may be convertible into equity securities; or ● units comprised of, or other combinations of, the following address: foregoing securities. We may from time to time offer and sell up to $125,000,000 of common stockthese securities separately or together, preferred stock, warrants to purchase common stock in one or preferred stock more series or any combination of the foregoing, either individually or classes and in unitsamounts, at prices and on terms described in one or more supplements offerings. We may offer securities through underwriting syndicates managed or co-managed by one or more underwriters or dealers, through agents or directly to purchasers. The prospectus supplement for each offering of securities will describe in detail the plan of distribution for that offering. For general information about the distribution of securities offered, please see “Plan of Distribution” in this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securitiesour securities are offered, we will provide a prospectus supplement containing more specific terms related to such offers in a supplement information about the particular offering and attach it to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed quoted on the Nasdaq Capital Market under the symbol “BPTHGRYP.” On May 14, 2019, the The last reported sales sale price per share of our common stock on the Nasdaq NASDAQ Capital Market on February 27, 2024 was $18.002.60 per share. We will sell these securities directlyThe aggregate market value of our outstanding common stock held by non-affiliates is $88,592,834 based on 38,733,554 shares of outstanding common stock, through agentsof which 34,074,167 shares are held by non-affiliates, dealers or underwriters and a per share price of $2.60 which was the closing sale price of our common stock as designated from time to time, or through a combination of these methods. For additional information quoted on the methods NASDAQ Capital Market on February 27, 2024. If we decide to seek a listing of saleany preferred stock, you should refer to the section titled “Plan of Distribution” in warrants, subscriptions rights, debt securities or units offered by this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable related prospectus supplement will set forth disclose the names exchange or market on which the securities will be listed, if any, or where we have made an application for listing, if any. About This Prospectus ii Cautionary Statement Regarding Forward-Looking Statements iii Prospectus Summary 1 Risk Factors 14 Use of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public Proceeds 15 Plan of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION Distribution 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 Description of Securities We May Offer 19 Forms of Securities 27 Legal Matters 29 Experts 29 Where You Can Find Additional Information 29 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “Commission, or SEC”) using , utilizing a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoingoffer and sell, either individually or in unitscombination, in one or more offerings offerings, any of the securities described in this prospectus, for total gross proceeds of up to an offering amount of $125,000,000100,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offeredoffer. Each time we offer securities hereunderunder this prospectus, we will provide specific terms related to such offering in a prospectus supplement to this prospectusprospectus that will contain more specific information about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplements supplement and any related free writing prospectus that we may authorize to be provided to you may also add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the prospectus, any applicable prospectus supplementsupplement and any free writing prospectuses we have authorized for use in connection with a specific offering, together with the information incorporated herein by reference as described under the sections titled heading Where You Can Find More Information” and “Information Incorporated Incorporation of Documents by Reference,below. If there is before investing in any inconsistency between of the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplementsecurities being offered. You should rely only on the information we have provided contained in, or incorporated by reference in into, this prospectus and the any applicable prospectus supplement, along with the information contained in any free writing prospectuses we have authorized for use in connection with a specific offering. We have not authorized anyone to provide you with different or additional information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute is an offer to sell or only the solicitation of an offer securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to buy do so. The information appearing in this prospectus, any securities other than the registered securities to which they relate, nor do this applicable prospectus supplement or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this related free writing prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial conditionregardless of the time of delivery of this prospectus, results any applicable prospectus supplement or any related free writing prospectus, or any sale of operations and prospects may have changed since those datesa security. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled entitled “Where You Can Find More Additional Information.” Unless the context requires otherwiseThis prospectus contains, references in this prospectus to “we,” “our,” “us,” “the Company” or incorporates by reference, trademarks, tradenames, service marks and “Bio-Path” refer to Bio-Path Holdingsservice names of Gryphon Digital Mining, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiarysubsidiaries.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference into this prospectus supplement and the accompanying prospectus certain information that we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those documentsanother document that we have filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus supplement supplement, and subsequent information that we file with the accompanying prospectus, except for SEC will automatically update and supersede that information. You should read the information incorporated by reference because it is an important part of this prospectus supplement. Any statement contained in a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus supplement to the extent that is superseded by information a statement contained in this prospectus supplement and the accompanying prospectusmodifies or replaces that statement. This means that you must look at all of the SEC filings that we We incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus following information or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: SEC (excluding those portions of any Form 8-K that are not deemed “filed” pursuant to the General Instructions of Form 8-K): • our Annual Report on Form 10-K for the fiscal year ended December 31, 20192021 filed with the SEC on March 1, 2022; • the information specifically incorporated by reference in our Annual Report on Form 10-K for the year ended December 31, 2021, from our definitive proxy statement relating to our 2022 annual meeting of stockholders, filed with the SEC on April 29, 2022; • the description of our common stock contained in Exhibit 4.7 to our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 1, 2022, including any amendment or report filed for the purpose of updating such description; • our Quarterly Report on Form 10-Q for the quarter three months ended March 31, 20202022 filed with the SEC on May 10, 2022; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; and • our Current Reports on Form 8-K filed with the SEC on January 12, 2022 (excluding information furnished thereunder), February 15, 2022 (excluding information furnished thereunder), and March 1025, 2020 and July 6, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information2022. We also incorporate by reference all into this prospectus supplement additional documents that we subsequently may file in with the future pursuant to Section SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after prior to the completion or termination of the offering, but excluding any information deemed furnished and not filed with the SEC. Any statements contained in a previously filed document incorporated by reference into this prospectus supplement is deemed to be modified or superseded for purposes of this prospectus supplement to the extent that a statement contained in this prospectus supplement, or in a subsequently filed document also incorporated by reference herein, modifies or supersedes that statement. This prospectus supplement may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated by reference in this prospectus supplement. You should rely only on the information incorporated by reference or provided in this prospectus supplement. We have not authorized anyone else to provide you with different information. You should not assume that the information in this prospectus supplement is accurate as of any date other than the date of this prospectus supplement until or the termination date of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, incorporated by reference in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsthis prospectus supplement. We will provide to each person, including any beneficial owner, to whom a this prospectus supplement and accompanying prospectus are is delivered, without charge upon written or oral request, at no cost to the requester, a copy of any or and all of the documents information that are is incorporated by reference into in this prospectus supplement and the accompanying prospectus supplement, but not delivered with the prospectus supplement and accompanying prospectussupplement, including other than exhibits which to such documents unless such exhibits are specifically incorporated by reference into the documents that this prospectus supplement incorporates. Requests for such documents. documents should be directed to: You may request also access the documents incorporated by reference in this prospectus supplement through our website at ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. Except for the specific incorporated documents listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus supplement or the registration statement of which it forms a copy part. Inclusion of these filings at no costour website address in this prospectus supplement is an inactive textual reference only. ImmunityBio, by writing Inc. may offer, from time to or telephoning us at the following address: time, We may from time to time time, in one or more offerings, offer and sell up to $125,000,000 of common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or preferred stock debt securities, or any combination of the foregoing, either individually or in unitsas units comprised of one or more of the other securities. This prospectus provides a general description of the securities we may offer. This prospectus may not be used to sell securities unless accompanied by a prospectus supplement, at prices which will describe the method and on the terms described of the offering. We will provide you with the specific amount, price and terms of the applicable offered securities in one or more supplements to this prospectus. We may also offer securities as may authorize one or more free writing prospectuses to be issuable upon conversion, redemption, repurchase, exchange or exercise of provided to you in connection with these offerings. A prospectus supplement and any securities registered hereunder, including any applicable anti-dilution provisions. This free writing prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectusprospectus with respect to that offering. Before you invest, you You should carefully read this prospectus prospectus, the information and the applicable prospectus supplementdocuments incorporated, as well the documents incorporated or deemed to be incorporated, by referenced reference in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the , and any applicable prospectus supplementsupplement and any related free writing prospectus carefully before you purchase any of our securities offered hereby. Our common stock is currently listed on the Nasdaq Capital Global Select Market under the symbol “BPTHIBRX.” On May 14February 24, 20192022, the last reported sales sale price per share of our common stock on the Nasdaq Capital Global Select Market was $18.007.04 per share. We will sell these There is currently no market for the other securities directlywe may offer. Investing in our securities involves risks. Please carefully read the information under the headings “Risk Factors” beginning on page 6 of this prospectus and in any similar section contained in or incorporated by reference herein, including, without limitation, our Annual Report on Form 10-K filed with the SEC on March 1, 2022, or in the applicable prospectus supplement before you invest in our securities. These securities may be offered and sold to or through one or more underwriters, dealers and agents, dealers or underwriters as designated from time directly to timepurchasers, or through a combination of these methods. If underwriters, dealers, or agents are used to sell the securities, we will name them and describe their compensation in a prospectus supplement. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution” for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing the method and terms of the offering of such securities. The date of this prospectus is May 18, 2022. TABLE OF CONTENTS Page Forward-Looking Statements 6 Dividend Policy 7 Legal Matters 23 This prospectus is part of a registration statement on Form S-3 that we filed with the U.S. Securities and Exchange Commission, or the SEC, using a “shelf” registration process. Under this shelf registration process, we may, from time to time, offer or sell any combination of the securities described in this prospectus in one or more offerings. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplement or any related free writing prospectus may also add to, update or change information contained in this prospectus and, accordingly, to the extent inconsistent, information in this prospectus is superseded by the information in the prospectus supplement. Each prospectus supplement will provide the amount, price, terms and plan of distribution relating to the securities to be sold pursuant to such prospectus supplement. For additional information on the methods of sale, you should refer to the section titled entitled “Plan of Distribution” in this prospectus. If No person has been authorized to give any agentsinformation or make any representations in connection with this offering other than those contained or incorporated by reference in this prospectus, dealers or underwriters are involved in the sale of these securities, the applicable any accompanying prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable feesrelated issuer free writing prospectus in connection with the offering described herein and therein. We and any agent, commissions underwriter or discounts. The price dealer take no responsibility for, and can provide no assurance as to the public reliability of, any other information others may give you. Neither this prospectus nor any prospectus supplement nor any related issuer free writing prospectus shall constitute an offer to sell or a solicitation of an offer to buy offered securities in any jurisdiction in which it is unlawful for such securities and the net proceeds that we expect person to receive from make such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000or solicitation. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any does not contain all of the information included in the registration statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement, including its exhibits. Statements contained in this prospectus about the provisions or in contents of any agreement or other document are not necessarily complete. If the SEC’s rules and regulations require that an agreement or document be filed as an exhibit to the registration statement, please see that agreement or document for a complete description of these matters. You should read the entire prospectus and any prospectus supplement and any related issuer free writing prospectus, as well as the documents that we have incorporated by reference into this prospectus or any prospectus supplement or any related issuer free writing prospectus, before making an investment decision. We urge You should also read and carefully consider the information in the documents we have referred you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled in “Where You Can Find More Information” and “Incorporation of Certain Information Incorporated by Reference.below. If there is any inconsistency between Neither the information in delivery of this prospectus and or any prospectus supplement, you should rely on supplement or any issuer free writing prospectus nor any sale made hereunder shall under any circumstances imply that the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson herein or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction prospectus supplement or issuer free writing prospectus is correct as of any date subsequent to any person to whom it is unlawful to make the date hereof or of such offer prospectus supplement or solicitation in such jurisdictionissuer free writing prospectus, as applicable. You should assume that the information appearing in this prospectus, any prospectus is accurate only as of the date on the front of the supplement or any document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by referenceapplicable documents, regardless of the time of delivery of this prospectus or any sale of securities. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Informationthat date.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Open Market Sale Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference into information in this prospectus supplement and the accompanying prospectus certain information that we file with the SEC, which document. This means that we are disclosing can disclose important information to you by referring you to those documentsanother document filed separately with the SEC. The information incorporated by reference is deemed considered to be part of this prospectus supplement and the accompanying prospectusdocument, except for any information incorporated by reference that is superseded by information contained that is included directly in this document. We are incorporating by reference the filings listed below and any additional documents that we may file with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act on or after the date of this prospectus supplement and until the accompanying prospectus. This means that you must look at all termination of the SEC filings that any offering, except we incorporate are not incorporating by reference to determine if any statements in this prospectus supplementinformation furnished (but not filed) under Item 2.02 or Item 7.01 of any Current Report on Form 8-K and corresponding information furnished under Item 9.01 as an exhibit thereto, the accompanying prospectus or any document previously incorporated by reference have been modified or supersededunless specifically referenced below. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: our Our Annual Report on Form 10-K for the fiscal year ended December 31, 20192023, filed with the SEC on February 21, 2024; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Our Current Reports on Form 8-K filed with the SEC on March 10February 9, 2020 and July 6, 20202024; and • the The description of our common stock shares contained in Exhibit 4.17 4.3 to our Annual Report on Form 10-K for the fiscal year ended December 31, 20192023, as filed with the SEC on February 21, 2024. Any information statement contained in any of this prospectus supplement, the foregoing documents will automatically accompanying prospectus or in a document incorporated or deemed to be incorporated by reference herein, shall be deemed to be modified or superseded to the extent that information in this prospectus supplement a statement contained herein, or in a later any subsequently filed document that also is incorporated or deemed to be incorporated herein by reference herein, modifies or replaces supersedes such informationstatement. We also incorporate by reference all documents we subsequently file in the future pursuant Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date constitute a part of this prospectus supplement until the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsprospectus. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and the accompanying prospectus are delivered, without charge upon written or oral request, delivered a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, herein or therein (including any exhibits which that are specifically incorporated by reference into such in those documents. You may request a copy of these filings ) at no cost, cost upon written or oral request. Any such request can be made by writing to or telephoning calling us at the following addressaddress and telephone number: We may from time to time offer and sell up to $125,000,000 American States Water Company ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Attn: Corporate Secretary (▇▇▇) ▇▇▇-▇▇▇▇ Copies of common stockthese filings are also available, preferred stockwithout charge, warrants to purchase common stock or preferred stock or any combination of on the foregoing, either individually or in units, SEC’s website at prices ▇▇▇.▇▇▇.▇▇▇ and on terms described in one or more supplements to this prospectus. We may also offer securities our website at ▇▇▇.▇▇▇▇▇▇▇.▇▇▇ as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides soon as reasonably practicable after they are filed electronically with the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectusSEC. The prospectus supplements may also add, update or change information contained in on our website is not a part of this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information Statements contained in this prospectus or in supplement as to the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is contents of any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson contract or other person is authorized documents are not necessarily complete, and in each instance investors are referred to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as copy of the date on the front of the contract or other document and that any information we have incorporated by reference is accurate only filed as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits an exhibit to the registration statement, each such statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwise, references being qualified in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction all respects by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease reference and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 exhibits and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug productsschedules thereto.

Appears in 1 contract

Sources: Equity Distribution Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to incorporate by reference into this prospectus supplement the information and the accompanying prospectus certain information that reports we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those these documents. The information incorporated by reference is deemed to be an important part of this prospectus supplement and the accompanying prospectus, except for information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectussupplement. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates We are incorporating by reference the documents set forth below that listed below, which we have previously already filed with the SEC: · Our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 14, 2025; · The information specifically incorporated by reference into our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • 2023 from our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders14A, filed November 1with the SEC on April 29, 20192024; • our · Our Current Reports Report on Form 8-K filed with the SEC on March 10onMarch 17, 2020 and July 6, 20202025; and • the · The description of our common stock securities contained in our registration statement onForm 8-A filed with the SEC on January 24, 2023, including any amendments or reports filed for the purposes of updating this description, including Exhibit 4.17 4.3 to our Annual Report on Form 10-K for the fiscal year ended December 31, 20192024 filed with the SEC on March 14, 2025. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all All documents we subsequently file in the future pursuant to Section Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act on or after the date of this prospectus supplement until and before the termination later of (1) the completion of the offering. These documents include periodic reportsoffering of the securities described in this prospectus supplement, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case2) if applicable, the portions furnished and not filed date the Agents stop offering securities pursuant to Item 2.02this prospectus supplement will also be incorporated by reference in this prospectus supplement from the date of filing of such documents. Upon request, Item 7.01 or otherwise), as well as any proxy statements. We we will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, without charge upon written or oral request, is delivered a copy of any or all of the information that has been incorporated by reference in this prospectus but not delivered with this prospectus supplement. Notwithstanding the preceding, unless specifically stated to the contrary, none of the information that we disclose under Items 2.02 or 7.01 or, if related to Items 2.02 or 7.01, Item 9.01 of any Current Report on Form 8-K that we may, from time to time, furnish to the SEC will be incorporated by reference into, or otherwise included in, this prospectus. The information contained in each of the documents incorporated by reference speaks only as of the date of such document. Any statement contained in a document incorporated by reference or deemed to be incorporated by reference herein, or contained in this prospectus, shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained herein or in any subsequently filed document or report that also is incorporated by reference or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus. We have filed with the SEC a registration statement under the Securities Act relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration statement. You can obtain a copy of the registration statement from the SEC at the address listed above. The registration statement and the documents referred to above are also available on our corporate website at ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. Unless specifically listed above, the information contained on the SEC website or our website is not incorporated by reference into this prospectus supplement and the accompanying prospectus but you should not delivered with the prospectus supplement and accompanying consider that information a part of this prospectus, including exhibits which are specifically incorporated by reference into such documents. You may request obtain a copy of any of these filings documents at no cost, by writing to or telephoning us at the following address: This prospectus may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated by reference in this prospectus supplement. You should rely only on the information incorporated by reference or provided in this prospectus supplement. We have not authorized anyone else to provide you with different information. You should not assume that the information in this prospectus is accurate as of any date other than the date of this prospectus supplement or the date of the documents incorporated by reference herein. We may offer and sell, from time to time offer and sell in one or more offerings, up to $125,000,000 200,000,000 in the aggregate of common stockany combination of the securities identified above from time to time in one or more offerings, preferred stock, warrants to purchase either individually or in combination with other securities. We may also offer common stock or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or any combination of common stock, preferred stock or debt securities upon the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offeredwarrants. Each time we offer to and sell securities, we will provide specific terms related to such offers in a supplement to this prospectusprospectus that contains specific information about the offering and the amounts, prices and terms of the securities. We may also authorize one or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplements supplement and any related free writing prospectuses may also add, update or change information contained in this prospectusprospectus with respect to that offering. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplementsupplement and any related free writing prospectus, as well the as any documents incorporated by referenced reference, before you invest in any of our securities. We may offer and sell the securities described in this prospectusprospectus and any prospectus supplement to or through one or more underwriters, dealers and agents, or directly to purchasers, or through a combination of these methods. This prospectus may not be used to consummate a If any underwriters, dealers or agents are involved in the sale of securities unless accompanied by any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution” for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing the method and terms of the offering of such securities. Our common stock is currently listed on the Nasdaq Capital Global Market (“Nasdaq”) under the symbol “BPTH.” ▇▇▇▇”. On May 14January 24, 20192024, the last reported sales price per share of for our common stock on the Nasdaq Capital Market was $18.005.40 per share. As of January 25, 2024, the aggregate market value of our outstanding common stock held by non-affiliates, or public float, was approximately $66.7 million, based on 48,634,591 shares of outstanding common stock, of which 39,744,609 shares were held by affiliates, and a price of $7.50 per share, which was the price at which our common stock was last sold on Nasdaq on December 26, 2023 (a date within 60 days of the date hereof). We will sell these have not offered any securities directly, through agents, dealers or underwriters as designated from time pursuant to time, or through a combination General Instruction I.B.6 of these methods. For additional information Form S-3 during the prior 12-calendar-month period that ends on and includes the methods date of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities registered on this registration statement in a public primary offering with a value exceeding more than one-third of our public float in any agents12-month period so long as our public float remains below $75 million (the “Baby Shelf Limitation”). We are an “emerging growth company” and “smaller reporting company” under the federal securities laws, dealers or underwriters and, as such,are involved subject to reduced public company reporting requirements. See “The Company—Implications of Being an Emerging Growth Company and Smaller Reporting Company.” Investing in our securities involves a high degree of risk. You should review carefully the sale risks and uncertainties described under the heading “Risk Factors” on page 3 of these securitiesthis prospectus, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and in any applicable feesfree writing prospectuses, commissions or discounts. The price to and under similar headings in the public of such securities and the net proceeds documents that we expect to receive from such sale will also be set forth in a supplement to are incorporated by reference into this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY Summary 1 USE OF PROCEEDS Risk Factors 3 Cautionary Statement Regarding Forward-Looking Statements 4 Use of Proceeds 5 Description of Capital Stock 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES Description of Debt Securities 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 Description of Warrants 20 Description of Units 22 Plan of Distribution 23 Legal Matters 25 Experts 25 Where You Can Find More Information 25 Important Information Incorporated by Reference 26 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (Commission, or the SEC”) using , utilizing a “shelf” registration process. Under this shelf registration statement process, we may from time to time offer and sell shares of our common stock and preferred stock, preferred stockvarious series of debt securities, warrants to purchase common stock or preferred stock or any of such securities and/or units consisting of any combination of the foregoingsuch securities, either individually or in unitscombination with other securities, in one or more offerings offerings, up to an offering a total dollar amount of $125,000,000200,000,000, subject to the Baby Shelf Limitation. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offeredoffer. Each time we offer securities hereunderunder this prospectus, we will provide a prospectus supplement that will contain more specific information about the terms related of that offering. We may also authorize one or more free writing prospectuses to such offering in a supplement be provided to this prospectusyou that may contain material information relating to these offerings. The prospectus supplements supplement and any related free writing prospectus we have authorized for use in connection with a specific offering may also add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and prospectus, the applicable prospectus supplementsupplement and any free writing prospectuses we have authorized for use in connection with a specific offering, together with the information incorporated herein by reference as described under the sections titled section entitled Where You Can Find More Information” and “Important Information Incorporated by Reference” below. If there is ”, before buying any inconsistency between of the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplementsecurities being offered. You should rely only on the information we have provided contained in, or incorporated by reference in into, this prospectus and prospectus, the applicable prospectus supplementsupplement and any free writing prospectuses, along with the information contained in any free writing prospectuses we have authorized for use in connection with a specific offering. We have not authorized anyone to provide you with different or additional information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute is an offer to sell or only the solicitation of an offer securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to buy any securities other than do so. The information appearing in this prospectus, the registered securities to which they relate, nor do this applicable prospectus supplement or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this related free writing prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus, the applicable prospectus supplement or any related free writing prospectus, or any sale of a security. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled heading “Where You Can Find More Information.” ”. On January 24, 2023 (the “Closing Date”), as contemplated by, the Agreement and Plan of Merger, dated as of August 3, 2022 (the “Merger Agreement”), by and among Jack Creek Investment Corp., a Cayman Islands exempted company (“JCIC”), Wildfire New PubCo, Inc., a Delaware corporation and direct, wholly-owned subsidiary of JCIC (“Bridger”), Wildfire Merger Sub I, Inc., a Delaware corporation and direct, wholly-owned subsidiary of Bridger, Wildfire Merger Sub II, Inc., a Delaware corporation and direct, wholly-owned subsidiary of Bridger, Wildfire Merger Sub III, LLC, a Delaware limited liability company and direct, wholly-owned subsidiary of Bridger, Wildfire GP Sub IV, LLC, a Delaware limited liability company and direct, wholly-owned subsidiary of Bridger, BTOF (Grannus Feeder)—NQ L.P., a Delaware limited partnership, and Bridger Aerospace Group Holdings, LLC, a Delaware limited liability company (“Legacy Bridger”), consummated the transactions contemplated by the Merger Agreement, whereby Bridger became a publicly traded company, with JCIC and Legacy Bridger becoming wholly-owned subsidiaries of Bridger (the “Business Combination”). On the Closing Date, Bridger changed its name to Bridger Aerospace Group Holdings, Inc. Unless the context requires indicates otherwise, references in this prospectus to the weCompany,” “ourBridger,” “we,” “us,” “the Companyour,” and “Bio-Path” similar terms refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Bridger Aerospace Group Holdings, Inc.’s wholly-owned subsidiary, Bio-Patha Delaware corporation (formerly known as Wildfire New PubCo, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug productsconsolidated subsidiaries.

Appears in 1 contract

Sources: Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating file annual, quarterly and other reports, proxy statements and other information with the SEC. The SEC allows us to incorporate by reference into this prospectus supplement and the accompanying prospectus certain information that we file with the SECthem, which means that we are disclosing can disclose important information to you by referring you to those documents. The information incorporated by reference is deemed considered to be part of this prospectus supplement supplement, and the accompanying prospectus, except for later information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of filed with the SEC filings that we will update and supersede this information. We incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth listed below that we have previously filed with the SEC, except that information furnished under Item 2.02 or Item 7.01 of our Current Reports on Form 8-K or any other filing where we indicate that such information is being furnished and not filed under the Exchange Act, is not deemed to be filed and not incorporated by reference herein: our Annual Report on Form 10-K for the fiscal year ended December 31, 20192020 as filed with the SEC on February 11, 2021; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports on Form 8-K as filed with the SEC on March 10January 14, 2020 2021, January 19, 2021, January 20, 2021, and July 6January 22, 20202021; and the description of our common stock contained in Exhibit 4.17 to our Annual Report the registration statement on Form 108-K for A as filed with the fiscal year ended December 31SEC on February 28, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information2005. We also incorporate by reference all into this prospectus supplement additional documents that we subsequently may file in with the future pursuant to Section SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the completion or termination of the offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information deemed furnished and not filed with the SEC. Any statements contained in a previously filed document incorporated by reference into this prospectus supplement is deemed to be modified or superseded for purposes of this prospectus supplement to the extent that a statement contained in this prospectus supplement, or in a subsequently filed document also incorporated by reference herein, modifies or supersedes that statement. This prospectus may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated by reference in this prospectus. You should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone else to provide you with different information. You should not assume that the information in this prospectus is accurate as of any date other than the date of this prospectus supplement until or the termination date of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, incorporated by reference in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsthis prospectus. We will provide to each person, including any beneficial owner, to whom a this prospectus supplement and accompanying prospectus are is delivered, without charge upon written or oral request, at no cost to the requester, a copy of any or and all of the documents information that are is incorporated by reference into in this prospectus. We will provide to each person, including any beneficial owner, to whom this prospectus supplement is delivered, upon written or oral request, at no cost to the requester, a copy of any and all of the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including exhibits which are specifically information that is incorporated by reference into such documentsin this prospectus supplement. You may request a copy of these filings filings, at no costcost to you, by telephoning us at (▇▇▇) ▇▇▇-▇▇▇▇ or by writing to or telephoning us at the following address: We may from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus. We You may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well access the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and supplement on the applicable prospectus supplementSEC’s website ▇▇▇▇▇.▇▇▇.▇▇▇ or through our website at ▇▇▇.▇▇▇▇▇.▇▇▇. We have not authorized anyone The reference to provide you with different information. No dealerour website is an inactive textual reference only and, salesperson except for the specific incorporated documents listed above, no information available on or other person is authorized through our website shall be deemed to give any information or to represent anything not contained be incorporated in this prospectus or supplement, the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This accompanying prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is it forms a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Sales Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The rules of the SEC allow us to incorporate by reference into in this prospectus supplement and the accompanying prospectus certain information in other documents that we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those documentsdocuments that we have filed separately with the SEC. The You should read the information incorporated by reference because it is deemed to be an important part of this prospectus supplement and the accompanying prospectus, except for information incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectussupplement. This means that you must look at all of the SEC filings that we We hereby incorporate by reference to determine if any statements in the following information or documents into this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: our Annual Report on Form 10-K for the fiscal year ended December 31, 20192020, filed on March 26, 2021; our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders2021, filed November 1on May 17, 20192021; • our ● the Current Reports on Form 8-K filed with the SEC Commission on March 1026, 2020 2021, June 3, 2021, June 22, 2021 and July 62, 20202021; and • the description of our common stock contained as set forth in our registration statement filed on Form 8-A under the Exchange Act on May 8, 1984, as amended by: ● the description of our common stock as set forth in Exhibit 4.17 4.4 to our the Annual Report on Form 10-K for the fiscal year ended December 31, 20192020, filed on March 26, 2021; and ● the description of our Series 1 Preferred as set forth in the Current Report on Form 8-K filed with the Commission on March 9, 2020. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in any future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items) made with the future SEC pursuant to Section Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement Act, until the termination of the offering. These documents include periodic reports, such offering as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements. We will provide to each person, including any beneficial owner, to whom a which this prospectus supplement relates. Information in such future filings updates and accompanying prospectus are delivered, without charge upon written or oral request, a copy of any or all of supplements the documents that are incorporated by reference into information provided in this prospectus supplement and the accompanying prospectus but not delivered prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any information in any document we previously filed with the prospectus supplement and accompanying prospectus, including exhibits which are specifically SEC that is incorporated or deemed to be incorporated herein by reference into to the extent that statements in the later filed document modify or replace such documentsearlier statements. You may request obtain a copy of these filings at no costfilings, without charge, by writing to or telephoning calling us at the following addressat: We CADIz INC. By this prospectus and an accompanying prospectus supplement, we may from time to time offer and sell sell, in one or more offerings, up to $125,000,000 205,000,000 in any combination of debt securities, common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination depositary shares, warrants, subscription rights and units. This prospectus provides you with a general description of the foregoing, either individually or in units, at prices and on these securities. We will provide you with more specific terms described of these securities in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions. This Any prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update update, or change information contained in this prospectus. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplementsupplement or issuer free writing prospectus relating to a particular offering, as well as the documents incorporated or deemed to be incorporated by referenced reference in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00carefully before you invest. We will may offer these securities from time to time in amounts, at prices and on other terms to be determined at the time of the offering. We may offer and sell these securities directly, to or through agentsunderwriters, dealers or underwriters as designated from time agents, or directly to timeinvestors, or through a combination of these methods, on a continuous or delayed basis. For additional information on The supplements to this prospectus will provide the methods specific terms of sale, you should refer to the section titled plan of distribution. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution” in beginning of pages 1 and 20, respectively, for more information. No securities may be sold without delivery of this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, prospectus and the applicable prospectus supplement will set forth describing the names method and terms of the agents, dealers or underwriters and any applicable fees, commissions or discountsoffering of such securities. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a the applicable prospectus supplement. Our common stock is listed on the Nasdaq Global Market under the symbol “CDZI”. On June 15, 2021, the closing price of our common stock as reported by the Nasdaq Global Market was $13.17 per share. We will provide information in any applicable prospectus supplement to this prospectusregarding the listing of securities other than shares of our common stock on any securities exchange. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 THE COMPANY 3 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 Corporate Information 3 About Cadiz 3 USE OF PROCEEDS 5 RISK FACTORS 4 General 5 DESCRIPTION OF WARRANTS DEBT SECURITIES 5 Consolidation, Merger or Sale 7 Conversion or Exchange Rights 7 Modifications of Indenture; Waiver 8 Events of Default under the Indenture 7 Form, Exchange and Transfer 9 Discharge 9 Payment and Paying Agents 10 Information Concerning the Trustee 10 Subordination of Subordinated Debt Securities 10 Governing Law 10 General 11 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP 11 Series 1 Preferred Stock 11 Common Stock 11 Indemnification of Directors and Officers 14 Future Class or Series of Preferred Stock 13 Anti-Takeover Effects of Delaware Law and Certain Provisions of our Charter Documents 14 Exchange Listing 14 General 16 DESCRIPTION OF SECURITIES 13 DEPOSITARY SHARES 16 Withdrawal of Preferred Stock 17 Dividends and Other Distributions 16 Voting Deposited Preferred Stock 17 Redemption, Conversion and Exchange of Preferred Stock 17 Charges of Preferred Stock Depositary; Taxes and Other Governmental Charges 18 Amendment and Termination of the Deposit Agreement 18 Miscellaneous 18 Resignation and Removal of Depositary 18 Exercise of Warrants 19 DESCRIPTION OF WARRANTS 19 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 20 DESCRIPTION OF SUBSCRIPTION RIGHTS 20 General 21 PLAN OF DISTRIBUTION 16 20 Dealers 22 Underwriters and Agents 21 Institutional Purchasers 22 Direct Sales 22 Market-Making, Stabilization and Other Transactions 23 Indemnification; Other Relationships 22 EXPERTS 23 LEGAL MATTERS 23 INFORMATION INCORPORATED BY REFERENCE 24 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 23 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (Commission, or the “Commission” or the “SEC”) ,” using a the “shelf” registration process. Under this the shelf registration statement process, using this prospectus, together with a prospectus supplement, we may sell from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or securities described in units, this prospectus in one or more offerings up to an offering amount of $125,000,000offerings. This prospectus provides you with a general description of the securities we that may offer and the general manner in which these securities will be offered. Each time we offer sell securities hereunderpursuant to this prospectus, we will provide a prospectus supplement that will contain specific information about the terms related of the securities being offered. A prospectus supplement may include a discussion of any risk factors or other special considerations applicable to such offering in a supplement those securities or to this prospectusus. The prospectus supplements supplement may addalso add to, update or change any of the information contained in this prospectus or and, accordingly, to the extent inconsistent, the information in this prospectus will be superseded by the information in the documents that we have prospectus supplement. You should read this prospectus, any applicable prospectus supplement and any related issuer free writing prospectus, as well as the additional information incorporated by reference into this prospectus. We urge you to read carefully in this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described below under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is or in any inconsistency between the information in this applicable prospectus supplement and any prospectus supplementrelated issuer free writing prospectus, you should rely on the information contained before making an investment in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those datesour securities. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, or will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” You may rely only on the information contained or incorporated by reference in this prospectus. Neither we nor any other person has authorized anyone to provide any information other than that contained or incorporated by reference in this prospectus, any accompanying prospectus supplement or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. Neither this prospectus nor any accompanying prospectus supplement nor any free writing prospectus prepared by or on behalf of us or to which we have referred you constitutes an offer to sell nor a solicitation of an offer to buy any securities other than those registered by this prospectus, or an offer to sell or a solicitation of an offer to buy securities where an offer or solicitation would be unlawful. This prospectus does not contain all of the information included in the registration statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement, including its exhibits. Unless the context requires otherwiseotherwise requires, references in this prospectus to the terms “we,” “us,” “our,” “usCadiz,” and “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Cadiz Inc., is sometimes referred to herein as “Bio-Path Subsidiarya Delaware corporation.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Credit Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating This registration statement incorporates by reference into important business and financial information about our Company that is not included in or delivered with this prospectus supplement document. The information incorporated by reference is considered to be part of this prospectus, and the accompanying prospectus certain SEC allows us to “incorporate by reference” the information that we file with the SECit, which means that we are disclosing can disclose important information to you by referring you to those documentsdocuments instead of having to repeat the information in this prospectus. The information Any statement contained in any document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in or omitted from this prospectus or any accompanying prospectus supplement, or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement and prospectus. We incorporate by reference: • Our Annual Report on Form 10-K for the accompanying prospectusfiscal year ended December 31, except for 2021, filed on February 28, 2022. • The information specifically incorporated by reference that is superseded by information contained in this prospectus supplement and the accompanying prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: • into our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; 2021 from our definitive proxy statement on Schedule 14A (other than information furnished rather than filed), which was filed with the SEC on April 8, 2022. our Our Quarterly Report Reports on Form 10-Q for the quarter quarters ended March 31, 2020; 2022, June 30, 2022, and September 30, 2022 filed on May 9, 2022, August 4, 2022, and November 7, 2022, respectively. our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Our Current Reports on Form 8-K or Form 8-K/A, filed on April 1, 2022, May 11, 2022, May 17, 2022, May 19, 2022 (with the SEC on March 10respect to items 5.02, 2020 5.03, 5.07 and 9.01), May 23, 2022, June 1, 2022, July 612, 2020; 2022, August 11, 2022, August 18, 2022 and November 7, 2022. the description The Description of our common stock contained in Class A Common Stock filed as Exhibit 4.17 4.1 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in a later 2021, filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section 13(a)on February 28, 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement until the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statements2022. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are is delivered, without charge upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectus, including exhibits which are specifically incorporated by reference into such documents. You may request a copy of these filings at no cost, should direct any requests for documents by writing to us at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ Road, Lordstown, Ohio 44481, or by telephoning us at the following address: We may from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, at prices and on terms described in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti(▇▇▇) ▇▇▇-dilution provisions. This prospectus provides the general terms of the securities we may offer and the general manner in which these securities will be offered. Each time we offer to sell securities, we will provide specific terms related to such offers in a supplement to this prospectus. The prospectus supplements may also add, update or change information contained in this prospectus. Before you invest, you should carefully read this prospectus and the applicable prospectus supplement, as well the documents incorporated by referenced in this prospectus. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH▇▇▇▇.” On May 14, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through agents, dealers or underwriters as designated from time to time, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agents, dealers or underwriters are involved in the sale of these securities, the applicable prospectus supplement will set forth the names of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into this prospectus. We urge you to read carefully this prospectus and the applicable prospectus supplement, together with the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Information.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

Appears in 1 contract

Sources: Open Market Sale Agreement

INFORMATION INCORPORATED BY REFERENCE. We are incorporating The SEC allows us to “incorporate by reference into this prospectus supplement and reference” the accompanying prospectus certain information that we file with the SEC, them which means that we are disclosing can disclose important information to you by referring you to those documentsdocuments instead of having to repeat the information in this prospectus supplement and the accompanying prospectus. The information incorporated by reference is deemed considered to be part of this prospectus supplement and the accompanying prospectus, except for and later information that we file with the SEC will automatically update and supersede this information. Any statement contained in a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that is superseded a statement contained in this prospectus modifies or replaces that statement. We incorporate by reference the documents listed below and any future information filed (rather than furnished) with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act between the date of this prospectus and the termination of this offering, provided, however, that we are not incorporating any information furnished under Item 2.02 or Item 7.01 of any current report on Form 8-K: ∎ our Annual Report on F orm 10-K for the year ended December 31, 2019, filed with the SEC on February 27, 2020; ∎ the information specifically incorporated by reference into our Annual Report on F orm 10-K for the year ended December 31, 2018, from our Definitive Proxy Statement on S chedule 14A, filed with the SEC on April 26, 2019; ∎ our Current Report on F orm 8-K filed with the SEC on February 20, 2020; and ∎ the description of our common stock contained in our registration statement on F orm 8-A filed with the SEC on October 6, 2015, including any amendments or reports filed with the SEC for the purposes of updating this description. These documents may also be accessed on our website at ▇▇▇.▇▇▇▇▇▇.▇▇▇. Except as otherwise specifically incorporated by reference in this prospectus supplement and the accompanying prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in this prospectus supplement, the accompanying prospectus information contained in, or any document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC: • accessible through, our Annual Report on Form 10-K for the fiscal year ended December 31, 2019; • our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020; • our Definitive Proxy Statement on Schedule 14A relating to our 2019 Annual Meeting of Stockholders, filed November 1, 2019; • our Current Reports on Form 8-K filed with the SEC on March 10, 2020 and July 6, 2020; and • the description of our common stock contained in Exhibit 4.17 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus supplement or in website is not a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information. We also incorporate by reference all documents we subsequently file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date part of this prospectus supplement until and the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K (except, in any such case, the portions furnished and not filed pursuant to Item 2.02, Item 7.01 or otherwise), as well as any proxy statementsaccompanying prospectus. We will provide to each person, including any beneficial owner, to whom a prospectus supplement and accompanying prospectus are delivered, furnish without charge to you, upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus but not delivered with the prospectus supplement and accompanying prospectusreference, including exhibits which are specifically incorporated by reference into such documents. You may request a copy of to these filings at no cost, documents by writing to or telephoning us at the following address: We may from time to time offer and sell up to $125,000,000 of common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination 250,000,000 in the aggregate of the foregoing, either individually or in units, at prices and on terms described securities identified above from time to time in one or more supplements to this prospectus. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisionsofferings. This prospectus provides the you with a general terms description of the securities we may offer and the general manner in which these securities will be offeredsecurities. Each time we offer to and sell securities, we will provide specific terms related to such offers in a supplement to this prospectusprospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The prospectus supplements supplement may also add, update or change information contained in this prospectusprospectus with respect to that offering. Before you invest, you You should carefully read this prospectus and the applicable prospectus supplement, as well supplement before you invest in any of our securities. We may offer and sell the documents incorporated by referenced securities described in this prospectus. This prospectus may not be used and any prospectus supplement to consummate a sale of securities unless accompanied by the applicable prospectus supplement. Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On May 14or through one or more underwriters, 2019, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $18.00. We will sell these securities directly, through dealers and agents, dealers or underwriters as designated from time directly to timepurchasers, or through a combination of these methods. For additional information on the methods of sale, you should refer to the section titled “Plan of Distribution” in this prospectus. If any agentsunderwriters, dealers or underwriters agents are involved in the sale of these any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement will set forth supplement. See the names sections of the agents, dealers or underwriters and any applicable fees, commissions or discounts. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a supplement to this prospectus. ABOUT THIS PROSPECTUS ii PROSPECTUS SUMMARY 1 USE OF PROCEEDS 6 RISK FACTORS 4 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 5 DESCRIPTION OF WARRANTS 10 DESCRIPTION OF CAPITAL STOCK 7 LEGAL OWNERSHIP OF SECURITIES 13 DESCRIPTION OF UNITS 12 LEGAL MATTERS 18 PLAN OF DISTRIBUTION 16 WHERE YOU CAN FIND MORE INFORMATION 18 EXPERTS 18 INFORMATION INCORPORATED BY REFERENCE 18 This prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration statement process, we may from time to time sell common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination of the foregoing, either individually or in units, in one or more offerings up to an offering amount of $125,000,000. This prospectus provides you with a general description of the securities we may offer and the general manner in which these securities will be offered. Each time we offer securities hereunder, we will provide specific terms related to such offering in a supplement to this prospectus. The prospectus supplements may add, update or change any of the information contained in this prospectus or in the documents that we have incorporated by reference into entitled “About this prospectusProspectus” and “Plan of Distribution” for more information. We urge you to read carefully No securities may be sold without delivery of this prospectus and the applicable prospectus supplement, together with supplement describing the information incorporated herein by reference as described under the sections titled “Where You Can Find More Information” method and “Information Incorporated by Reference” below. If there is any inconsistency between the information in this prospectus and any prospectus supplement, you should rely on the information contained in that prospectus supplement. You should rely only on the information we have provided or incorporated by reference in this prospectus and the applicable prospectus supplement. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or the applicable prospectus supplement. You must not rely on any unauthorized information or representation. This prospectus or any applicable supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus or any applicable supplement to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should assume that the information in this prospectus is accurate only as terms of the date on the front offering of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find More Informationsuch securities.” Unless the context requires otherwise, references in this prospectus to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.” We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and Venclexta in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019. Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA). Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020. Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases. We have certain intellectual property as the basis for our current drug products in clinical development, specifically prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

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Sources: Sales Agreement