Financial Performance - For the year ended December 31, 2022, the company generated net income of $5.3 million, primarily from revenues related to AstraZeneca's sales of Vaxzevria and an agreement with OUI[287]. - The company incurred net losses of $61.2 million and $73.4 million for the years ending December 31, 2024 and 2023, respectively[287]. - As of December 31, 2024, the company had an accumulated deficit of $237.7 million[287]. - The company’s cumulative carryforward tax losses amounted to approximately $101.7 million as of December 31, 2024, up from $92.7 million as of December 31, 2023[419]. Cash and Funding - The company's cash, cash equivalents, and restricted cash were $112.4 million as of December 31, 2024, which is expected to support operations into the start of 2027 without additional financing[301]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially affecting its ability to continue operations[302]. - The company may require substantial additional funding to support ongoing operations and product development, with potential financing sources including public or private equity offerings and debt financings[307]. - The company may need to pursue equity or debt financings to meet capital needs, which could lead to significant dilution for existing stockholders[310]. Research and Development - The company does not expect to generate significant revenue from current or future product candidates until successful completion of clinical development and marketing authorization[290]. - The company has not yet generated any material revenue from its current product candidates[290]. - The company anticipates substantial increases in expenses as it pursues clinical and preclinical development of product candidates and expands operational capabilities[287]. - The company anticipates that research and development expenses will increase significantly as it continues preclinical and clinical development activities[308]. Clinical Trials and Regulatory Risks - The company faces significant translational risk as product candidates advance through clinical stages, with promising preclinical results not guaranteed to replicate in human trials[291]. - The company faces risks related to the successful completion of clinical trials, which are lengthy and expensive, and may not yield predictable outcomes[320]. - The company may experience delays in obtaining regulatory approvals for clinical trials, which could impact the timelines for product development[322]. - The marketing authorization processes from regulatory authorities like the FDA and EMA are lengthy and unpredictable, potentially harming the business if approvals are not obtained[396]. Product Development and Market Risks - The company’s ability to generate product revenues is heavily dependent on the successful development and commercialization of its product candidates, which may take several years[318]. - The company acknowledges that the addressable patient population for its product candidates may be limited, potentially impacting profitability without additional marketing authorizations for first or second-line therapies[346]. - The commercial success of the company's product candidates will depend on public acceptance of immunotherapies and could be adversely affected by negative developments in the field[347]. - The company faces substantial competition from various sources, including major pharmaceuticals and biotechnology companies, which may hinder its ability to successfully market its product candidates[354]. Manufacturing and Supply Chain Risks - The company does not currently own any facility for clinical-scale manufacturing and must rely on third-party manufacturers, exposing it to risks related to quality and supply[387]. - The production process for product candidates is complex, requiring specific know-how from a limited number of contract manufacturing organizations (CMOs), which may lead to competition for scarce manufacturing capacities[391]. - The company may face delays in clinical trials or commercial distribution if any CMO fails to perform its obligations, as alternative supply sources may not be secured on reasonable terms[392]. Intellectual Property Risks - The company relies heavily on in-licensed patents and patent applications, with no issued patents for its product candidates, which could materially harm its competitive position[457]. - The company cannot assure that its product candidates do not infringe existing patents, which could lead to costly litigation[473]. - The competitive landscape for acquiring third-party intellectual property rights is challenging, with more established companies having greater resources[482]. - Litigation to protect intellectual property rights could be expensive and time-consuming, with no guarantee of success[483]. Compliance and Legal Risks - The company must comply with Good Clinical Practice (GCP) regulations, and failure to do so could result in unreliable clinical data and regulatory delays[381]. - The company is subject to the Foreign Corrupt Practices Act and similar laws, which could result in significant penalties if violated[433]. - Non-compliance with data protection laws could result in fines up to €20 million or 4% of annual global revenue, whichever is greater[451]. - The company will face ongoing regulatory obligations and potential penalties if it fails to comply with regulatory requirements for its product candidates[424].
VACCITECH(VACC) - 2024 Q4 - Annual Report