Dare Bioscience (DARE) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01We will need to raise substantial additional capital to continue our operations and execute our business strategy, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all23% rewritten
2. 02Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in our technologies or product candidates and their future revenue streams50% rewritten
3. 03We have a limited operating history, a history of significant losses from operations, and expect significant losses from operations, net losses and negative cash flows from operations to continue for the foreseeable future, which, together with our limited financial resources, make it difficult to assess our prospects
4. 04The Revenue Sharing Threshold may never be achieved and, as a result, we may not realize any future income based on sales of XACIATO
5. 05To the extent we enter into licensing agreements for third-party commercialization of products we develop, as is the case with XACIATO, we expect our revenue streams related to those products will be based primarily on net sales, which will be largely outside of our control45% rewritten
6. 06If our commercial collaborator terminates its exclusive license agreement with us, our need for additional capital may significantly increase48% rewritten
7. 07would approve a proposed transaction. For example, we will need to obtain stockholder approval to sell more shares of our common stock to Lincoln Park under our equity line arrangement due to the limitations described above related to sales at less than the Minimum PriceNew
8. 08Uncertainty in U.S. federal government funding and contracting policies may adversely affect our business24% rewritten
9. 09Our cash could be adversely impacted if a financial institution with which we have deposit or other accounts fails37% rewritten

Risks Related to Product Research & Development and Regulatory Approval

1. 10Clinical development is a lengthy and expensive process with an inherently uncertain outcome. Failure to successfully develop and obtain regulatory approval to market and sell our product candidates, and in particular, Ovaprene and Sildenafil Cream, would likely adversely affect our business
2. 11Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable60% rewritten
3. 12A change in the regulatory approval pathway we anticipate for a product candidate could significantly increase development cost and timeline and heighten the risk of failure
4. 13Some of our product candidates may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approval31% rewritten
5. 14There has been recent regulatory activity and enforcement in the United States stemming from an announced shift by FDA toward “radical transparency” resulting in increased scrutiny and transparency in the pharmaceutical drug space that may impact our businessNew
6. 15Our clinical-stage product candidates have only been tested in a small number of women over short periods of use and no data exists regarding a potential increase in fetal abnormalities in pregnant women
7. 16Pre-clinical product candidates may be undervalued by investors and may be difficult to fund
8. 17Several of our product candidates are in pre-clinical stages of development and may never advance to clinical development

Risks Related to Our Dependence on Third Parties

1. 18on us, suspension of production, delay or failure to obtain product approval, product seizure or recall, or withdrawal of product approvalNew
2. 19clinical trial material or future approved product and CMOs may not be able to maintain the necessary governmental licenses and approvals to continue their manufacturing services for usNew
3. 20requirements, or otherwise perform in a substandard manner, we could suffer significant delays and additional costs in, and potentially failure of, the development of one or more of our product candidatesNew
4. 21ITEM 1. "BUSINESS-Strategic Agreements for Pipeline Development-SST License and Collaboration Agreement,” aboveNew

Risks Related to Commercialization of Products We Develop

1. 22impact their potential commercial success, which could have a material adverse effect on our business, financial condition and results of operationsNew
2. 23Our product candidates, if approved for commercial sale, will face intense competition and our business and operating results will suffer if we, or our commercial collaborators, fail to compete effectively29% rewritten
3. 24The women's health market includes many generic FDA-approved drug products, compounded drugs, as well as dietary supplements and consumer health products, and growth in these categories is expected to continue, which could make the successful introduction of our products difficult and expensive
4. 25Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would negatively impact our business
5. 26The commercial success of XACIATO is outside of our control and will depend on Organon’s efforts and capabilities, as well as a variety of factors, many of which currently are unknown or uncertain, and if commercialization of XACIATO is not successful, our business and prospects may suffer
6. 27If one or more of these risks occur, it could reduce the market potential for Ovaprene, or any other contraceptive product we develop, and place pressure on our business, financial condition, results of operations and prospects100% rewritten
7. 28future collaborations may also be important to us. If we are unable to maintain our existing collaboration, if it is not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed,” aboveNew
8. 29The commercial success of DARE-HRT1, if approved for commercial sale, will depend on the availability of alternative products for managing menopause symptoms, concerns about the safety of hormone therapy, and women's preferences, among other factors32% rewritten

Risks related to market acceptance of DARE-HRT1 include

1. 30Potential safety concerns regarding hormone therapy could adversely affect our businessNew
2. 31Unexpected safety, efficacy or quality concerns relating to XACIATO could develop, which could have significant negative consequences for us
3. 32If we suffer negative publicity concerning the safety or efficacy of XACIATO or the product candidates we develop, our reputation could be harmed, product sales could be adversely affected or we may be forced to cease or curtail product development efforts
4. 33We are and will remain subject to ongoing regulatory requirements even after obtaining regulatory approval for a product candidate
5. 34Failure to successfully obtain coverage and reimbursement for XACIATO and any future products in the United States, or the availability of coverage only at limited levels, would diminish our ability, or that of a commercial collaborator, to generate net product revenue or net sales
6. 35Legislation and legislative and regulatory proposals intended to contain health care costs may adversely affect our business
7. 36Even seemingly small copayments or other cost-sharing requirements could dramatically reduce the market potential for XACIATO and our product candidates
8. 37As no FDA-approved treatments for FSAD currently exist, there is little precedent to help assess whether health insurance plans will cover Sildenafil Cream, if approved for commercial sale
9. 38The commercial success of products we develop, if approved for commercial sale, will be impacted by the prescribing information approved by the FDA and comparable regulatory authorities outside the U.S
10. 39Manufacturing disruptions could cause significant delays and disruption in the commercial launch and/or supply shortages of any product we develop
11. 40If competitors obtain approval for generic versions of our products, our business may suffer
12. 41We will need to obtain FDA approval of any proposed prescription medical product name, and any failure or delay associated with such approval may adversely affect our business
13. 42Even if we receive marketing approval from the FDA, we may fail to receive similar approvals outside the U.S., which could substantially limit the value of our products

Risks Related to Section 503B Compounding

1. 43We plan to generate revenue from sales of DARE to PLAY and other potential 503B compounded drugs, but we have limited experience in this line of business and may not be successful in our effortsNew
2. 44We are and will remain reliant on Section 503B-registered outsourcing facilities to produce DARE to PLAY and potentially other 503B compounded drugs, and their failure to adequately perform their obligations could harm our reputation, business and financial condition61% rewritten
3. 45Our commercialization strategy for DARE to PLAY and other potential 503B compounded drugs relies on, and will rely on, third-party telehealth platforms, dispensing pharmacies, and other commercial partners, which subjects us to a variety of regulations and related potential liabilityNew
4. 46Achieving and maintaining market acceptance of DARE to PLAY produced and distributed under Section 503B could be negatively impacted by perceived risks associated with compounded drugs
5. 47Sildenafil citrate must remain on the list of bulk substances that may be used in compounding under Section 503B, and if it were to be removed, we would be unable to offer DARE to PLAY under Section 503B
6. 48If a compounded drug formulation provided by an outsourcing facility leads to patient injury or death, or results in a product recall, we may be exposed to significant liability and reputational harm

Risks Related to Employee Matters and Managing Our Growth

1. 49We have a relatively small number of employees to manage and operate our business
2. 50If we fail to attract and retain management and other key personnel, we may not successfully complete development of, obtain regulatory approval for or commercialize our product candidates, or otherwise implement our business plan
3. 51We may not be successful in our efforts to identify and acquire or in-license additional product candidates or technologies, which may limit our growth potential91% rewritten
4. 52companies and assets and in-licensing transactions beginning in 2017. We may engage in strategic transactions that could cause us to incur additional liabilities, commitments or significant expenseNew

Risks Related to Our Intellectual Property

1. 53persons located in other countries will engage in development, marketing or sales activities of products that would infringe our intellectual property rights if such activities were conducted in the U.S. and enforcing our intellectual property rights against such persons may be difficult or not possibleNew
2. 54In addition, because of funding limitations and our limited cash resources, we may not be able to devote the resources that we might otherwise desire to prepare or pursue patent applications, either at all or in all jurisdictions in which we might desire to obtain patents, or to maintain already-issued patents
3. 55We may become involved in patent litigation or other intellectual property proceedings relating to our future product approvals, which could result in liability for damages or delay or stop our development and commercialization efforts63% rewritten
4. 56We also rely upon trade secrets to protect our technology, product and product candidates, and trade secrets can be difficult to maintain and enforce
5. 57Confidentiality agreements with employees and others may not adequately prevent disclosure of our know-how, trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete
6. 58Provisions in our agreements with governmental agencies and non-profit organizations may affect our intellectual property rights and the value of our development programs to our company

Risks Related to Our Business Operations and Industry

1. 59expand our operations or to complete important acquisitions or other transactions, which could have a material adverse effect on our businessNew
2. 60Business interruptions resulting from public health crises, natural disasters or telecommunication and electrical failures may materially and adversely affect our business, operating results and financial condition
3. 61Product liability lawsuits against us could cause us to incur substantial liabilities
4. 62Our current or future employees, clinical investigators, commercial collaborators or service providers may engage in misconduct or other improper activities, including non-compliance with laws and regulatory standards
5. 63The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of health care reform, especially in light of the lack of applicable precedent and regulations
6. 64Our business may be adversely affected by general conditions in the global economy and financial markets and geopolitical tensions and events
7. 65We expect to continue to incur substantial costs and demands on management time to comply with laws and regulations affecting public companies
8. 66We are a smaller reporting company and a non-accelerated filer and the reduced disclosure requirements available to us may make our common stock less attractive to investors
9. 67Our ability to use net operating loss carryforwards and other tax attributes to offset taxable income may be limited

Risks Related to Ownership of Our Common Stock

1. 68The price of our common stock may rise and fall rapidly, substantial price fluctuations may occur regardless of developments in our business or our operating performance, and you could lose all or part of your investment as a result25% rewritten
2. 69There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital MarketNew
3. 70The sale of our common stock in ATM offerings or under our equity line arrangement may cause substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the price of our common stock to decline48% rewritten
4. 71The exercise of our outstanding warrants and options as well as the issuance of shares pursuant to future equity awards under our stock incentive plan may result in significant dilution to our stockholders28% rewritten
5. 72Substantial future sales of our shares of common stock, or the perception that such sales could occur, may cause the price of our common stock to decline, even if our business is doing well
6. 73sales, or the perception that such sales could occur, may continue for an extended period of time and continued negative pressure on the trading price of our common stock could have a material adverse effect on our ability to raise additional capital through equity or equity-linked financings
7. 74We have designated preferred stock with terms that could reduce the value of our common stock86% rewritten
8. 75We do not anticipate paying any cash dividends on our common stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our shares
9. 76Provisions in our certificate of incorporation, our by-laws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock
10. 77Provisions in our by-laws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
11. 78If we fail to attract or maintain securities analysts to publish research on our business or if they publish or convey negative evaluations of our business, the price of our stock could decline