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New words:
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Removed:
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Financial report summary
?Competition
Pfizer • AMGEN • Regeneron Pharmaceuticals • Incyte • Opko Health • Henry Schein • Cara Therapeutics • Vanda Pharmaceuticals • Fortress Biotech • TesaroRisks
- Our business is substantially dependent on the successful development of our BET inhibitor product candidates.
- Our product candidates are in early stages of development and may fail in development or suffer delays that materially and adversely affect their viability. If we are unable to complete development of, or commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
- We may encounter delays in enrolling patients and successfully completing clinical trials for our product candidates and may be delayed in, or prevented from, commencing such trials due to factors that are largely beyond our control.
- Drug development is very expensive, time-consuming and uncertain. Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates, or serious adverse side effects could be identified. Any of these outcomes could prevent or delay regulatory approval and commercialization or harm our ability to pursue strategic alternatives for our product candidates.
- Results obtained in preclinical studies and completed clinical trials may not predict success in later clinical trials.
- Top line and preliminary data from our clinical trials that we announce or publish from time to time may change as additional data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- We have a limited history as a clinical-stage biopharmaceutical company developing product candidates for immuno-inflammatory conditions, which may make it difficult to assess our future viability.
- We may spend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We have not obtained regulatory approvals to market our product candidates, and we may be delayed in obtaining or fail to obtain such regulatory approvals and to commercialize these product candidates.
- Even if our product candidates receive marketing approval, we may continue to face future developmental and regulatory difficulties. In addition, we are subject to government regulations and we may experience delays in obtaining required regulatory approvals to market our proposed product candidates.
- We rely on third parties to conduct, supervise and monitor our clinical studies, and if these third parties perform in an unsatisfactory manner, it may harm our business.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.
- Risks Related to our Financial Position and Need for Capital
- We will need substantial additional funding to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned operations.
- We have incurred significant losses since our inception and we anticipate that we will continue to incur significant losses for the foreseeable future, which could harm our future business prospects.
- SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3.
- Other Risks Related to Our Business and Financial Operations
- Collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
- Our failure to successfully in-license, acquire, develop and market additional product candidates or approved products could impair our ability to grow our business.
- We may engage in strategic transactions, which could impact our liquidity, increase our expenses and present significant distractions to our management.
- We may decide not to continue developing any of our product candidates at any time during development or of any of our products after approval, which would reduce or eliminate our potential return on investment for those product candidates or products.
- Supply interruptions may disrupt the availability of our product candidates and cause delays in conducting preclinical or clinical activities.
- We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
- The Israeli Tax Authority may disagree with our conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
- If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully execute our strategy.
- We may become subject to lawsuits or investigations that could have a material adverse impact on our business, results of operations and financial condition.
- Our employees, independent contractors, principal investigators, consultants, vendors, CROs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our business.
- Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
- We are subject to various U.S. federal, state, local and foreign health care fraud and abuse laws, including anti-kickback, self-referral, false claims and fraud laws, health information privacy and security, and transparency laws, and any violations by us of such laws could result in substantial penalties or other consequences including criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
- Healthcare reforms by governmental authorities and related reductions in pharmaceutical pricing, reimbursement and coverage by third party payors may adversely affect our business.
- Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates and to produce, market, and distribute our products after clearance or approval is obtained.
- We and our contract manufacturers are subject to significant regulation with respect to manufacturing of our product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
- Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
- We are subject to various U.S. and foreign anti-bribery and anti-corruption laws, and any violations by us of such laws could result in substantial penalties.
- Our business involves the use of hazardous materials and we and our third party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- Sanctions and other trade control laws create the potential for significant liabilities, penalties and reputational harm.
- Risks Related to Our Intellectual Property
- If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to any of our product candidates are not adequate, we may not be able to compete effectively and we otherwise may be harmed.
- The trading price of the shares of our common stock is volatile, and stockholders could incur substantial losses.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
- Our amended and restated certificate of incorporation and our amended and restated bylaws contain exclusive forum selection clauses, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are eligible to report as a “smaller reporting company,” and as a result of the reduced reporting requirements applicable to such companies, our securities may be less attractive to investors.
- An active public market for our common stock may not be sustained.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
- We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
- We incur significant costs and demands upon management as a result of being a public company.
- We are subject to risks related to climate change in the long term.
Management Discussion
- * Percentage not meaningful.
- Revenues totaled $0.1 million for each of the three months ended March 31, 2024 and 2023, consisting of royalty revenue from our royalty agreement with LEO Pharma.
- Our research and development expenses for the three months ended March 31, 2024 were $3.7 million, representing an increase of $1.0 million, or 35.6%, compared to $2.7 million for the three months ended March 31, 2023. The increase was primarily driven by preparatory activities for the Phase 1 trials for VYN202 and Phase 2b trial for VYN201 of $0.7 million and $0.3 million, respectively.