Talphera (TLPH) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Need for Additional Capital

1. 01We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future
2. 02Launch of a commercial pharmaceutical or medical device product and the required development activities associated with those products can be time consuming and costly. We expect to incur significant expenditures in connection with supporting our research and development activities for our product candidates
3. 03If we are unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital is not expected to be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern
4. 04relinquish, or license on unfavorable terms, our rights to technologies, products or product candidates that we otherwise would seek to develop or commercialize ourselves
5. 05To fund our operations and capital requirements, we may sell additional equity securities, which may result in dilution to our stockholders, or debt securities, or enter into a new debt facility which may impose restrictions on our business
6. 06We have not yet generated significant product revenue and may never be profitable
7. 07launching and commercializing our product candidates, if approved, in the United States by building, internally or through collaborations, an institutionally focused sales force, which may require additional funding64% rewritten
8. 08In October 2024, Alora notified us that they had discontinued their DSUVIA sales efforts to non-DoD customersNew

Risks Related to Drug Development and Commercialization

1. 09We may fail to realize the benefits expected from our acquisition of Lowell, which could adversely affect our stock price
2. 10Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales
3. 11the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate
4. 12Our development efforts might not generate successful product candidates
5. 13If we do not accomplish one or more of these goals in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would harm our business
6. 14Moreover, clinical data is often susceptible to multiple interpretations and analyses. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products
7. 15have the product removed from the market after obtaining marketing approval
8. 16If we experience delays or difficulties in enrolling patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
9. 17proximity and availability of clinical trial sites for prospective patients
10. 18If serious adverse effects or unexpected characteristics of our product candidates are identified during development, we may need to abandon or limit the development of some or all of our product candidates
11. 19We may expend 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
12. 20The process for obtaining approval of a PMA or NDA is time consuming, subject to unanticipated delays and costs, and requires the commitment of substantial resources
13. 21Our expectations for FDA approvability of our product candidates may be inaccurate, and we may be required to conduct additional manufacturing, nonclinical or clinical development work in order to obtain FDA approval for these products, which would add to our expenses and delay any associated revenue
14. 22our partners may not comply with applicable government regulatory requirements necessary to successfully market and sell our products
15. 23If we, or current and potential partners, are unable to compete effectively, our products may not reach their commercial potential
16. 24Coverage and adequate reimbursement may not be available for our product candidates, if approved, in the United States and in Europe, which could make it difficult for us, or our partners, to sell our products profitably
17. 25The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
18. 26If we or our partners are unable to establish and maintain relationships with group purchasing organizations any future revenues or future profitability could be jeopardized

Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters

1. 27Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices we may obtain92% rewritten

Risks Related to Our Reliance on Third Parties

1. 28We will rely on third party manufacturers to produce clinical supplies of our product candidates. The failure of third-party manufacturers to provide us with adequate clinical supplies, and if approved, commercial supplies, could result in a material adverse effect on our business
2. 29the failure to deliver our products under specified storage conditions and in a timely manner
3. 30We rely on limited sources of supply for the active ingredient and finished product of our nafamostat-based product candidates and any disruption in the chain of supply may cause a delay in developing our product candidates44% rewritten
4. 31Manufacturing issues may arise that could delay or increase costs related to product development and regulatory approval
5. 32We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business

Risks Related to Our Business Operations and Industry

1. 33Our relationships with clinical investigators, health care professionals, consultants, commercial partners, third-party payers, hospitals, and other customers are subject to applicable anti-kickback, fraud and abuse and other healthcare laws, which could expose us to significant penalties
2. 34Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us
3. 35Business interruptions could delay our operations and sales efforts
4. 36Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
5. 37We may acquire companies, product candidates or products or engage in strategic transactions, which could divert our management ’ s attention and cause us to incur various costs and expenses
6. 38Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading

Risks Related to Our Intellectual Property

1. 39If we cannot defend our issued patents from third party claims or if our pending patent applications fail to issue, our business could be adversely affected
2. 40Litigation involving patents, patent applications and other proprietary rights is expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing our products to market and interfere with our business
3. 41It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
4. 42the patents of others will not have an adverse effect on our business
5. 43We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
6. 44Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be paid to the United States Patent and Trademark Office and various foreign governmental patent agencies in several stages over the lifetime of the patents and/or applications
7. 45We may not be able to enforce our intellectual property rights throughout the world
8. 46We have not yet registered our trademarks in all our potential markets, and failure to secure those registrations could adversely affect our business

Risks Related to Ownership of Our Common Stock

1. 47The market price of our common stock has historically been and may continue to be highly volatile
2. 48trading volume of our common stock22% rewritten
3. 49Our common stock may be delisted from The Nasdaq Capital Market if we cannot regain compliance with Nasdaq ’ s continued listing requirements29% rewritten
4. 50Sales of a substantial number of shares of our common stock in the public market by us or our stockholders could cause our stock price to fall
5. 51We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
6. 52Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management
7. 53establishing advance notice requirements for nominations for election to our Board of Directors or for proposing matters that can be acted upon at stockholder meetings
8. 54Litigation may substantially increase our costs and harm our business41% rewritten
9. 55International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
10. 56Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
11. 57Our effective tax rate may fluctuate, we may be adversely affected by changes in tax laws and regulations, and we may incur obligations in tax jurisdictions in excess of accrued amounts53% rewritten