Content analysis
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H.S. senior Bad
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New words:
absence, addressing, affirmative, agreeable, Aktieselskab, Alan, Asheville, CARC, carcinogenicity, Carolina, category, charge, Collateral, committed, cure, CVR, Danish, deadline, deficiency, delisting, dermal, Dissenting, dose, enacted, enjoining, evidence, forgo, frame, grantee, guarantee, guaranteed, Guarantor, half, Holding, illegal, impairment, iv, ix, John, Joseph, LEO, Lucchese, Mendelsohn, nonappealable, Notwithstanding, occupied, ointment, Parent, payout, Pharma, PK, principal, prohibiting, proxy, Recommendation, repayment, repeat, restraining, retention, rodent, Society, solicit, Spiny, submit, submitted, Superior, surrender, thereon, toxicity, trust, unvested, vi, vii, viii
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Financial report summary
?Risks
- We have a limited operating history and have never generated any product revenue.
- We will require substantial additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of any of our product candidates.
- We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability. Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
- Our business is heavily dependent on the successful development, regulatory approval and commercialization of our product candidates.
- Raising additional funds by issuing equity securities may cause dilution to existing equity holders, raising additional funds through debt financings may involve restrictive covenants, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- Issuance of our common stock upon exercise of convertible securities may depress the price of our common stock.
- Our stock price can be volatile, which increases the risk of litigation, and may result in a significant decline in the value of your investment.
- If we are unable to effectively maintain a system of internal control over financial reporting, we may not be able to accurately or timely report our financial results and our stock price could be adversely affected.
- We are subject to extensive and costly government regulation.
- We do not have, and may never obtain, the regulatory approvals we need to market our product candidates.
- If we are unable to file for approval of TMB-001 under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to safety and efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization timelines.
- Even if we are able to commercialize any product candidate that we may develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business.
- We rely on our acquisition agreements to provide rights to certain intellectual property relating to our lead product candidates, TMB-001 and TMB-003. Any termination or loss of significant rights under any such agreements would adversely impact our development or commercialization of such product candidates.
- We may not be successful in our efforts to identify and acquire or in-license additional product candidates, or to enter into collaborations or strategic alliances for the development and commercialization of any such future product candidates.
- If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
- We face risks related to health epidemics and outbreaks of communicable diseases, including COVID-19, which could significantly disrupt our preclinical studies and clinical trials.
- International expansion of our business exposes us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business outside of the United States.
- Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates.
- We may acquire businesses, assets or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.
- If our studies encounter difficulties or fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
- We face significant competition from other biotechnology and pharmaceutical companies that currently are targeting medical dermatological indications that we are studying, and our operating results will suffer if we fail to compete effectively.
- If the market opportunities for our product candidates are smaller than we believe them to be, our revenues may be adversely affected and our business may suffer. Because the target patient populations of our product candidates are small, we must be able to successfully identify patients and capture a significant market share to achieve and maintain profitability.
- The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. Even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.
- We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
- Any product candidate for which we obtain marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities.
- If any of our product candidates receive marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market such drug could be compromised.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
- There are risks associated with scaling up manufacturing to commercial scale. If our contract manufacturers are unable to manufacture our drug candidates on a commercial scale, this could potentially delay regulatory approval and commercialization or materially adversely affect our results of operations.
- If we obtain approval to commercialize any of our products outside of the United States, a variety of risks associated with international operations could harm our business.
- Legislative and regulatory changes may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain.
- Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
- We rely, and expect to continue to rely, on third parties to conduct our clinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies.
- We may seek to enter into collaborations with third parties for the development and commercialization of our product candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.
- If we are not able to establish collaborations, we may have to alter our development and commercialization plans.
- It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.
- If we fail to obtain or maintain patent protection or trade secret protection for our technologies, third parties could use our proprietary information, which could impair its ability to compete in the market and adversely affect its ability to generate revenues and attain profitability.
- We have acquired portions of our intellectual property, and if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor and/or seller of such intellectual property.
- Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.
- We may be subject to claims challenging the inventorship of its patents and other intellectual property.
- We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology.
- There are risks to our intellectual property based on our international business operations.
- We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
Management Discussion
- For the year ended December 31, 2022, grant revenue was approximately $0.08 million compared to $0.6 million for the year ended December 31, 2021. The decrease in revenue of approximately $0.5 million was due to the reduction of reimbursements received from the FDA as a result of achieving certain clinical milestones in the development of TMB-001, and the reimbursements under the grant were completed in 2022. In September 2018, Patagonia was awarded a $1.5 million grant (the “Grant”) from the FDA as part of the Orphan Products Clinical Trials Grants Program of the Office of Orphan Products Development. The Grant funds were made available in three annual installments of $500,000 per year, which commenced in September 2018. The Grant was transferred to us pursuant to our TMB-001 Acquisition Agreement with Patagonia in February 2019. In March 2020 and March 2021, the FDA awarded us the second and third tranches of the grant, respectively.