CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. This prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the respective dates of this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, as applicable, and are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein, and any applicable free writing prospectus. The events and circumstances reflected in our forward- looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, whether as a result of any new information, future events, changed circumstances or otherwise.
Appears in 1 contract
Sources: Atm Equity Offering Sales Agreement
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying base Any statements in this prospectus, any accompanying prospectus supplement and the documents information incorporated by reference herein and therein by reference relating to future financial or business performance, conditions or strategies and any applicable free writing prospectus may contain other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of Section 27A the Private Securities Litigation Reform Act of the Securities Act and Section 21E of the Exchange Act1995. All statements other than statements that are not descriptions of historical facts contained in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statementsstatements and are based on management’s estimates, assumptions, and projections that are subject to risks and uncertainties. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to can generally be materially different from any future results, performance or achievements expressed or implied identified by the use of forward-looking statements. This prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify forward-looking statements by terms words such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “projectwill,” “should,” “targetanticipate,” “willestimate” or “would” or similar terminology. Although we believe that the negative of these terms or other similar expressions. The expectations reflected in our forward-looking statements are reasonable as of the date we make them, actual results could differ materially from those currently anticipated due to a number of factors, including risks relating to: • our estimates regarding expenses, future revenue, capital requirements, tax credits and timing and availability of and the need for additional financing; • the results, cost and timing of our preclinical studies and clinical trials, including any delays to such clinical trials relating to enrollment or site initiation, as well as the number of required trials for regulatory approval and the criteria for success in this prospectus supplementsuch trials; • our dependence on third parties in the conduct of our preclinical studies and clinical trials; • legal and regulatory developments in the United States and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress or outcome of clinical trials or result in the need for additional clinical trials; • the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates, and the indication and labeling under any such approval; • our plans and ability to develop and commercialize our product candidates; • the successful development of our commercialization capabilities, including medical affairs and sales and marketing capabilities, whether alone or with potential future collaborators; • the size and growth of the potential markets for our product candidates, the accompanying base prospectusrate and degree of market acceptance of our product candidates and our ability to serve those markets; • the coverage and reimbursement status for our product candidates from third-party payors; • the success of competing therapies and products that are or become available; • our ability to limit our exposure under product liability lawsuits; • our ability to obtain and maintain intellectual property protection for our product candidates; • recently enacted and future legislation regarding the healthcare system, including changes to the documents incorporated by reference herein Patient Protection and therein Affordable Care Act; • our ability to obtain and any applicable free writing prospectus are only predictions. We have based these forwardmaintain third-looking statements largely party manufacturing for our product candidates on commercially reasonable terms; • delays, interruptions or failures in the manufacture and supply of our current expectations product candidates; • the performance of third parties upon which we depend, including third-party contract research organizations, contract manufacturing organizations, contractor laboratories and projections about future events independent contractors; • our ability to recruit or retain key scientific, commercial or management personnel or to retain our executive officers; • our ability to maintain proper functionality and financial trends security of our internal computer and information systems and prevent or avoid cyberattacks, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption; • the other risks, uncertainties and factors discussed in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, under the caption “Item 1A. Risk Factors.” Further information on the factors and risks that we believe may could affect our business, financial condition and results of operations. These forward-looking statements speak only as of the respective dates of operations are set forth in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, as applicable, and are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus supplementour filings with the SEC, which are available at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇. Any forward- looking statement speaks only as of the accompanying base prospectus, the documents incorporated by reference herein and thereindate on which it is made, and we undertake no obligation to update any applicable free writing prospectus. The events and circumstances reflected in our forward- looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environmentstatement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management us to predict all risk which factors and uncertaintieswill arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Except as required by applicable law, we do not plan undertake no obligation to publicly update or revise any our forward-looking statements contained in to reflect events or circumstances that arise after the date of this prospectus supplement, or the accompanying base prospectus, the date of documents incorporated by reference herein and therein and any applicable free writing in this prospectus, whether as a result of any new information, future events, changed circumstances or otherwise.
Appears in 1 contract
Sources: Sales Agreement
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. This prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the respective dates of this prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, as applicable, and are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein, and any applicable free writing prospectus. The events and circumstances reflected in our forward- forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained in this prospectus, any applicable prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, whether as a result of any new information, future events, changed circumstances or otherwise.
Appears in 1 contract
Sources: Atm Equity Offering Sales Agreement
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. This When used in this prospectus and any accompanying prospectus supplement, the accompanying base prospectus, including the documents that we have incorporated by reference herein and therein and any applicable free writing prospectus may contain reference, in future filings with the SEC or in press releases or other written or oral communications, statements which are not historical in nature, including those containing words such as “believe,” “expect,” “anticipate,” “estimate,” “plan,” “continue,” “intend,” “should,” “may” or similar expressions, are intended to identify “forward-looking statements statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this prospectus supplementAct and, the accompanying base prospectusas such, the documents incorporated by reference herein and therein and any applicable free writing prospectus, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements may involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statementsassumptions. This prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify These forward-looking statements include information about possible or assumed future results of our business, financial condition, liquidity, results of operations, plans and objectives. Statements regarding the following subjects are forward- looking by terms such their nature: • our business and investment strategy; • our forecasted operating results; • our ability to obtain future financing arrangements; • our expected leverage levels; • our understanding of our competition; • market trends and expectations in our industry; • our anticipated capital expenditures; and • our ability to maintain our qualification as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” a real estate investment trust, or “would” or the negative of these terms or other similar expressionsREIT, for federal income tax purposes. The forward-looking statements in this prospectus supplementare based on our beliefs, assumptions and expectations of our future performance, taking into account all information available to us at the accompanying base prospectus, time the documents incorporated by reference herein and therein and any applicable free writing prospectus are only predictions. We have based these forward-looking statements largely on our current are made. These beliefs, assumptions and expectations and projections about future can change as a result of many possible events and financial trends that we believe may affect or factors, not all of which are known to us. If a change occurs, our business, prospects, financial condition condition, liquidity and results of operationsoperations may vary materially from those expressed in our forward- looking statements. These You should carefully consider this risk when you make an investment decision concerning our securities. Additionally, the following factors could cause actual results to vary from our forward-looking statements: • the factors discussed in this prospectus and any prospectus supplement, including those set forth under the section titled “Risk Factors,” and the sections captioned “Risk Factors” in our most recent Annual Report on Form 10-K, as amended by Amendment No. 2 thereto, subsequent Quarterly Reports on Form 10-Q and other documents that we file with the SEC; • general volatility of the capital markets and the market prices of our listed securities; • performance of our industry in general; • changes in our business or investment strategy; • availability, terms and deployment of capital; • availability of and our ability to attract and retain qualified personnel; • our leverage levels; • our capital expenditures; • changes in our industry and the markets in which we operate, interest rates or the general U.S. or international economy; • our ability to maintain our qualification as a REIT for federal income tax purposes; and • the degree and nature of our competition. All forward-looking statements speak only as of the respective dates of this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, as applicable, and date on which they are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein, and any applicable free writing prospectus. The events and circumstances reflected in our forward- looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environmentmade. New risk factors risks and uncertainties may emerge from arise over time to time, and it is not possible for management to predict all risk factors and uncertaintiesthose events or how they may affect us. Except as required by applicable law, we do are not plan obligated to publicly update or revise any forward-looking statements contained in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectusstatements, whether as a result of any new information, future events, changed circumstances events or otherwise.
Appears in 1 contract
Sources: Sales Agreement
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying base prospectus, the and documents incorporated herein by reference herein and therein and any applicable free writing prospectus may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements within the meaning involve a number of Section 27A risks and uncertainties. We caution readers that any forward- looking statement is not a guarantee of the Securities Act future performance and Section 21E of the Exchange Act. All statements other than statements of historical facts that actual results could differ materially from those contained in this prospectus supplementthe forward-looking statement. These statements are based on current expectations of future events. Such statements include, the accompanying base prospectusbut are not limited to, the documents incorporated by reference herein and therein and any applicable free writing prospectus, including statements regarding expectations and intentions, costs and expenses, outcome of contingencies, financial condition, results of operations, liquidity, cost savings, objectives of management, debt financing, our future results of operations and financial position, business our commercialization strategy, research business strategies, market size, potential growth opportunities, clinical development activities, efficacy and development plans, the anticipated timing, costs, design, and conduct safety profile of our ongoing product candidates, timing and planned results of our development activities, preclinical studies and planned clinical trials for lorundrostat trials, the receipt and any future timing of potential regulatory designations, the achievement of clinical and commercial milestones, the advancement of our technologies and our proprietary product candidates, the timing approvals and likelihood commercialization of regulatory filings product candidates and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, other statements that are not historical facts. In some cases you can identify these statements by forward-looking statementswords such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions, in documents incorporated by reference into this prospectus or any free writing prospectus. These statements involve known and unknown risks, uncertainties and other important factors We intend that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the such forward-looking statementsstatements be subject to the safe harbors created thereby. This prospectus supplementThese forward-looking statements are based on the current beliefs and expectations of our management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, the accompanying base actual results may differ materially from current expectations and projections. Factors that might cause such a difference include those discussed in our most recent Annual Report on Form 10-K and any subsequent Quarterly Report on Form 10-Q,, as well as those discussed in this prospectus, the documents incorporated by reference herein and therein into this prospectus and any applicable free writing prospectus may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industryprospectus. This data involves a number of assumptions and limitations, and you You are cautioned not to give place undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus are only predictions. We have based reliance on these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our businessstatements, financial condition and results of operations. These forward-looking statements which speak only as of the respective dates date of this prospectus supplementor, in the case of documents referred to or incorporated by reference, the accompanying base prospectus, date of those documents. All subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the documents incorporated by reference herein and therein and any applicable free writing prospectus, as applicable, and are subject cautionary statements contained or referred to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein, and section. We do not undertake any applicable free writing prospectus. The events and circumstances reflected in our obligation to release publicly any revisions to these forward- looking statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events, except as may not be achieved required under applicable U.S. securities law. If we do update one or occur and actual results could differ materially from those projected in the more forward-looking statements. Moreover, no inference should be drawn that we operate in an evolving environment. New risk factors and uncertainties may emerge from time will make additional updates with respect to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update those or revise any other forward-looking statements contained in this prospectus supplement, the accompanying base prospectus, the documents incorporated by reference herein and therein and any applicable free writing prospectus, whether as a result of any new information, future events, changed circumstances or otherwisestatements.
Appears in 1 contract
Sources: Sales Agreement