20-F: Apollomics Faces Going Concern Doubt Amid Program Cuts, Losses

Apollomics Inc. reported significant losses and a negative equity position for 2025, raising substantial doubt about its ability to continue as a going concern, following multiple drug program terminations and a deferred key U.S. regulatory filing.

Summary

• Incurred a net loss of $10.9 million for the year ended December 31, 2025, and used $10.4 million in net cash for operating activities.
• Reported an accumulated deficit of $711.8 million and net liabilities of $3.2 million as of December 31, 2025.
• Existing cash resources of $3.3 million as of December 31, 2025, are insufficient to meet obligations through April 30, 2027, even with an expected $2.3 million receivable from LaunXP International and a $2.0 million bridge loan from the CEO.
• Indefinitely deferred the U.S. New Drug Application (NDA) filing for vebreltinib for NSCLC with MET exon 14 skipping due to insufficient data and regulatory feedback.
• Terminated the exclusive collaboration and license agreement with GlycoMimetics for uproleselan in Greater China in February 2025, following negative Phase 3 global trial results, leading to a $10.0 million impairment loss on the intangible asset.
• Terminated the license for APL-810 from TYG in November 2024 as part of pipeline prioritization, effective January 2025.
• Formally terminated the Development and License Agreement for APL-122 with Edison Oncology Holding Corporation in December 2025, citing Edison's failure to meet material performance and reporting obligations.
• Entered into a definitive settlement agreement in November 2025 to resolve litigation with two minority investors (TWVC Entities), requiring payments of $5.0 million in cash plus approximately $0.9 million in legal fees over 24 months.
• Currently engaged in active litigation with Medpace, Inc., a CRO, which sued for allegedly unpaid service fees; Apollomics filed a counterclaim seeking over $2.0 million for misappropriation of pre-funded expenses and overcharges.
• Experienced a complete transition of executive leadership and Board of Directors in August and September 2025, including the appointment of a new Chairman and CEO, COO, and CFO.
• Successfully appealed a Nasdaq delisting determination in October 2025, which was based on the belief that the company had become a public shell, and regained compliance.
• Implemented cost reduction initiatives, including prioritizing vebreltinib and uproleselan development (before its termination), and reducing executive and non-executive employees, with significant operational functions transitioned to Taiwan and reduced headcount in China.
• Recognized revenue of $8.5 million for the year ended December 31, 2025, from an exclusive license agreement with LaunXP International for vebreltinib in Asia (excluding mainland China, Hong Kong, and Macau).
• As of December 31, 2025, owned 65 granted or issued patents and 24 pending patent applications related to drug candidates and technologies.

Sentiment

Score: 2

Explanation: StockSavvy.ai views this as a highly concerning report, primarily due to the explicit 'going concern' doubt, significant accumulated losses, and the indefinite deferral of a key U.S. regulatory filing for its lead product candidate, despite some positive NMPA approvals in China.

Positives

• Secured conditional NMPA approval in China for vebreltinib in NSCLC with Met Exon 14 skipping (November 2023), gliomas with PTPRZ1-MET fusion (April 2024), and MET-amplified NSCLC (June 2025).
• Received FDA orphan drug designation for vebreltinib for NSCLC with MET genomic tumor aberrations.
• Vebreltinib has demonstrated activity in a variety of tumors with MET fusions, with a 43% objective response rate (ORR) in non-CNS MET fusion solid tumors in the SPARTA Phase 2 trial.
• The safety profile of vebreltinib is generally acceptable, supported by data from over 500 patients across multiple clinical trials.
• Successfully closed a $4.1 million PIPE financing in September 2025, reversing prior wind-up plans.
• Remediated a material weakness in internal control over financial reporting identified in 2023, with no material weaknesses identified as of December 31, 2025.
• Successfully appealed a Nasdaq delisting determination and regained compliance with listing standards in October 2025.
• Received a $2.0 million unsecured convertible bridge loan from the Chairman and CEO, Mr. Hung-Wen (Howard) Chen, in March 2026, providing additional liquidity support.

Negatives

• Incurred significant net losses of $10.9 million in 2025, $53.9 million in 2024, and $172.6 million in 2023.
• Has an accumulated deficit of $711.8 million and negative shareholders' equity of $3.2 million as of December 31, 2025.
• Existing cash and cash equivalents of $3.3 million as of December 31, 2025, are insufficient to meet obligations through April 30, 2027, indicating substantial doubt about the ability to continue as a going concern.
• Indefinitely deferred the U.S. NDA filing for vebreltinib in NSCLC with MET exon 14 skipping due to insufficient data and regulatory feedback, requiring a large, randomized, controlled clinical trial for FDA approval.
• Terminated the uproleselan program and recorded a $10.0 million impairment loss due to negative Phase 3 trial results from licensor GlycoMimetics.
• Terminated APL-810 and APL-122 development programs as part of pipeline prioritization and due to licensor non-performance, respectively.
• Incurred a $1.7 million impairment loss for patent rights in 2025 due to the termination of a collaboration agreement.
• Settled litigation with minority investors for $5.0 million cash plus $0.9 million in legal fees, payable over 24 months, materially impacting cash flow.
• Engaged in active litigation with Medpace, Inc. over allegedly unpaid service fees, with an unfavorable outcome potentially harming financial condition.
• Experienced initial delays in receiving the full $10.0 million upfront payment from LaunXP, with $2.3 million outstanding as accounts receivable and $1.5 million not yet billed as of December 31, 2025.
• The trading price of securities has been and is likely to continue to be volatile, with a prior delisting threat from Nasdaq.

Risks

• The company is a pre-revenue biotechnology company with a history of losses and will need additional capital to meet operating cash requirements, which may not be available on acceptable terms or at all.
• Substantial dependence on the success of vebreltinib, the most advanced product candidate, with significant delays or failure to obtain regulatory approval and commercialization posing material harm to the business.
• No track record in launching and marketing any commercial products, relying on third parties or needing to develop internal capabilities, which may be costly and time-consuming.
• Future losses are uncertain, and operating results may fluctuate significantly or fall below expectations, causing share price volatility.
• Raising additional capital will likely result in dilution to shareholders and may restrict operations.
• Clinical trials may fail to adequately demonstrate safety, efficacy, and risk/benefit, preventing or delaying development, regulatory approval, and commercialization.
• Product candidates, once approved, may fail to achieve market acceptance by physicians, patients, third-party payors, and others in the medical community.
• Involvement in claims, disputes, litigation, arbitration, or other legal proceedings could be costly and time-consuming to defend.
• Reliance on third parties to manufacture or import clinical and commercial drug supplies, with risks of insufficient quantities, unacceptable quality, or increased prices.
• Reliance on third parties and collaborators/partners to conduct preclinical studies and clinical trials, with risks of contractual failures or missed deadlines.
• Failure to comply with environmental, health, and safety laws and regulations could result in fines or penalties.
• Collaborations or strategic alliances may not realize expected benefits, or may require relinquishing control or intellectual property rights.
• Inability to obtain licenses to promising oncology programs for American, European, and/or Chinese markets on desirable terms or at all.
• Failure to identify relevant third-party patents or incorrect interpretation of patent relevance, scope, or expiration could adversely affect the ability to develop and market products.
• All material aspects of pharmaceutical product R&D and commercialization are heavily regulated, with non-compliance potentially harming reputation and business.
• Regulatory approval processes are lengthy, time-consuming, and inherently unpredictable, with no guarantee of approval.
• FDA or other regulatory authorities may not accept data from clinical trials conducted outside the home jurisdiction.
• Inability to obtain or maintain orphan drug designation benefits, including marketing exclusivity, even if designation is granted.
• Government control of currency conversion and regulations on investment in PRC entities may delay transfers from PRC subsidiaries, restricting funding and business expansion.
• Business operations in China are subject to complex and rapidly evolving laws and regulations, with potential for significant government oversight and intervention.
• Exposure to cybersecurity and data protection laws in the PRC, with non-compliance potentially having a material adverse effect.
• Partners in China may be restricted from transferring scientific data or drug products for use abroad.
• Deterioration of trade relations between the United States and China could adversely affect commercialization and collaboration efforts.
• Political relationships among Greater China and other countries may affect business operations and collaboration prospects.
• Implementation of labor laws and regulations in China may adversely affect business and results of operations.
• Inability to obtain and maintain patent protection, or challenges to existing patent rights, could allow competitors to commercialize similar products.
• Limited geographical protection for certain patents, making it difficult to protect intellectual property rights globally.
• Inability to maintain confidentiality of trade secrets could harm business and future prospects.
• Changes in patent law could diminish the value of patents, impairing the ability to protect product candidates.
• Involvement in lawsuits to protect or enforce intellectual property could be expensive, time-consuming, and unsuccessful.
• Patent terms may be inadequate to protect competitive position for an adequate amount of time.
• Inadequate protection of trademarks and trade names could adversely affect name recognition and competitive position.
• The IRS may not agree that the company should be treated as a non-U.S. corporation for U.S. federal income tax purposes.
• Characterization as a passive foreign investment company (PFIC) could result in adverse U.S. federal income tax consequences for U.S. investors.
• No assurance of compliance with Nasdaq continued listing standards, risking delisting.
• The trading price of securities has been and is likely to continue to be volatile.
• Incurring significant increased expenses and administrative burdens as a public company.
• Provisions in the memorandum and articles of association may increase costs for investors to bring lawsuits or discourage lawsuits against directors and officers.
• No guarantee that warrants will ever be in the money, potentially expiring worthless.
• Terms of public and private warrants may be amended adversely to holders with majority approval.
• Mr. Hung-Wen (Howard) Chen, CEO and Chairman, exerts significant influence and may have conflicts of interest with other shareholders.

Future Outlook

The company anticipates continued net losses and negative operating cash flows for the foreseeable future as it advances clinical development, seeks regulatory approvals, identifies new product candidates, and incurs public company expenses. Management plans to address liquidity shortfalls by raising additional capital through equity or debt financing and generating cash inflows from strategic partnerships, though these are not contractually committed. The company intends to discuss vebreltinib's approvability for GBM with EMA in 2026 and expects LaunXP to complete its capital raising in Q2 2026 to fulfill outstanding payments.

Management Comments

• Management has determined that substantial doubt exists about the Company's ability to continue as a going concern.
• Management's plans to address this shortfall include raising additional capital through equity or debt financing and generating cash inflows from strategic partnerships; however, these plans are not contractually committed, are subject to external factors and there can be no assurance that such capital will be available on acceptable terms, or at all.
• We believe that the potential of vebreltinib in cancers with genetic mutations, amplification or fusion of the c-Met gene presents a significant opportunity for us.
• We believe vebreltinib may represent a valuable new treatment option to patients with NSCLC with Met Exon 14 skipping mutation in the U.S, an option differentiated from the ones available today.
• We strongly disputed Nasdaq's characterization of the company as a public shell and provided substantial evidence of operational continuity.
• We intend to continue our vigorous defense against Medpace's claims; however, an unfavorable outcome requiring us to pay amounts claimed by Medpace or an inability to recover damages under our Counterclaim, could adversely affect the Company's financial condition and results of operations.
• The Company has formally notified Dr. Yu's legal counsel that he is not entitled to the severance benefits due to serious misconduct and breaches of fiduciary duties of care and loyalty, particularly relating to his handling of the Series C preferred share redemption demands and the Cayman litigation.

Industry Context

StockSavvy.ai notes that the biotechnology sector, particularly for pre-revenue companies, is highly capital-intensive and susceptible to clinical trial outcomes and regulatory hurdles. The termination of multiple drug programs and the deferral of a key U.S. NDA filing for vebreltinib highlight the inherent risks in drug development. The shift towards strategic partnerships and cost-reduction initiatives is a common response for smaller biotech firms facing financial constraints and competitive pressures from larger pharmaceutical companies with greater resources. The focus on biomarker-driven diagnostics aligns with broader industry trends towards precision medicine in oncology, but the challenges in patient enrollment for specific genetic alterations underscore the difficulties in niche market development. The NMPA approvals in China for vebreltinib, while positive, do not fully offset the U.S. regulatory setbacks, reflecting the fragmented global regulatory landscape.

Comparison to Industry Standards

• Vebreltinib's conditional NMPA approvals in China for NSCLC with Met Exon 14 skipping, gliomas with PTPRZ1-MET fusion, and MET-amplified NSCLC position it alongside other c-Met inhibitors like capmatinib and tepotinib, which received accelerated and then traditional FDA approvals for NSCLC with Met Exon 14 skipping in 2020/2021 and 2022/2024, respectively. Savolitinib and gumarontinib are also approved in China for NSCLC with Met Exon 14 skipping.
• The 75% ORR and 15.9 months median DOR for vebreltinib in Chinese NSCLC patients with Met Exon 14 skipping (KUNPENG Study) are competitive with reported efficacy of other c-Met inhibitors in this indication. For example, capmatinib's ORR in treatment-naive patients with METex14-mutated NSCLC was 68% in the GEOMETRY mono-1 trial, and tepotinib's ORR was 43% in previously treated patients in the VISION trial.
• The 48% reduction in death risk for vebreltinib in GBM patients with PTPRZ1-MET fusion in Avistone's trial is a notable finding, as there is currently no approved targeted therapy for GBM with c-Met dysregulation in the U.S., indicating a potential unmet need compared to standard of care like temozolomide with radiation.
• The termination of the uproleselan program due to negative Phase 3 results from GlycoMimetics is a setback, contrasting with successful development of other E-selectin antagonists or similar therapies that may be progressing in the industry pipeline.
• The company's reliance on third-party CROs and CMOs is standard practice in the biotech industry, but the litigation with Medpace highlights the risks associated with outsourcing critical functions, which can lead to delays and increased costs compared to companies with integrated R&D and manufacturing capabilities.

Management Changes

Corporate Governance

Legal Proceedings

• Entered into a definitive settlement agreement in November 2025 to resolve litigation with two minority investors (TWVC Entities) in the Grand Court of the Cayman Islands. The settlement requires payments of $5.0 million in cash plus approximately $0.9 million in legal fees over 24 months.
• Currently engaged in active litigation with Medpace, Inc., a clinical research organization. Medpace sued for allegedly unpaid service fees of approximately $2.3 million (net $0.4 million after offsets). Apollomics filed an Amended Counterclaim seeking declaratory judgment and compensatory damages in excess of $2.0 million for Medpace's material breaches of contract, including misappropriation of pre-funded expenses and overcharges. An unfavorable outcome could materially adversely affect financial position.

Related Party Transactions

• On March 30, 2026, the company issued a Convertible Promissory Note to Mr. Hung-Wen (Howard) Chen, the Chairman and Chief Executive Officer, for a principal amount of $2.0 million. The note is unsecured, bears no interest, and will automatically convert into equity securities upon the closing of the next qualifying equity financing of at least $10.0 million at an 80% conversion price of the lowest per-share purchase price paid by investors in such financing. This transaction was independently reviewed and recommended by the Audit Committee and approved by the Board of Directors.

Stakeholder Impact

• Shareholders face significant dilution risk from future capital raises and potential volatility in share price due to ongoing financial uncertainties and clinical setbacks.
• Employees have experienced significant headcount reductions and operational restructuring, leading to workforce uncertainty, though new RSU awards aim to incentivize the remaining team.
• Creditors, particularly those involved in the TWVC litigation settlement, will receive payments over a 24-month period, impacting the company's cash flow.
• Customers (future patients) may experience delays in accessing vebreltinib in the U.S. market due to the deferred NDA filing, while access in China is expanding with recent NMPA approvals.
• Licensors and partners, such as LaunXP, are subject to the company's financial health and ability to meet obligations, as evidenced by the delayed upfront payment.

Next Steps

• Continue active enrollment for vebreltinib in NSCLC patients with c-Met amplification, confirmed by central FISH testing.
• Actively review data from previously and newly enrolled participants to determine next development steps for vebreltinib.
• Discuss with EMA the approvability of vebreltinib for GBM with PTPRZ1-MET fusion in 2026.
• Seek additional capital through equity or debt financings or strategic partnerships to fund operations.
• Continue active discussions with LaunXP International to advance the collaboration and secure outstanding payments, contingent on LaunXP's capital raising in Q2 2026.
• Vigorously defend against Medpace's legal claims and pursue recovery of damages under the counterclaim.

Key Dates

Recommendation

The company faces 'substantial doubt' about its ability to continue as a going concern, evidenced by significant accumulated losses, negative net equity, and insufficient cash to cover obligations for the next 12 months. Key U.S. regulatory filings for its lead product have been indefinitely deferred, and multiple other drug programs have been terminated. While there are some positive regulatory approvals in China and recent capital injections, these are insufficient to overcome the severe financial distress, ongoing litigation, and high operational risks. The high volatility and prior delisting threat from Nasdaq further underscore the precarious investment profile.

Keywords

Biotechnology, Oncology, Drug Development, Vebreltinib, c-Met Inhibitor, NSCLC, Glioblastoma, Clinical Trials, Regulatory Approval, SEC Filing, Going Concern, Capital Raise, Intellectual Property, China, Nasdaq, APLM