10-K: Liminatus Pharma Faces Nasdaq Delisting, Reports Wider Losses

Liminatus Pharma, Inc. reported a significant increase in net loss for 2025, raising substantial doubt about its going concern ability, and is non-compliant with multiple Nasdaq listing rules.

Summary

• Liminatus Pharma, Inc. is a pre-clinical stage biopharmaceutical company focused on developing novel cancer therapies, specifically a humanized anti-CD47 monoclonal antibody (IBA101).
• The company's next-generation CD47 antibody is designed to preferentially bind to immune cells, avoiding the red blood cell and platelet binding that caused anemia and thrombocytopenia in first-generation CD47 inhibitors like Magrolimab.
• Key preclinical studies, including CMC development and monkey toxicity studies, have been completed, with preparation for an IND application underway.
• Initial clinical trials for IBA101 as a monotherapy for advanced solid cancers are scheduled for 2026, with combination therapy trials (IBA101 + Durvalumab or pembrolizumab) for Stage III NSCLC planned for 2027, both focusing on South Korea.
• New potential therapeutic applications for the CD47 asset were discovered, including reducing chronic inflammation and inducing weight loss, suggesting utility in age-related diseases like cardiovascular disease and obesity.
• The company reported a net loss of $10,206,517 for the year ended December 31, 2025, significantly wider than the $3,546,309 loss in 2024.
• Cash used in operating activities increased substantially to $9,963,318 in 2025 from $1,451,066 in 2024.
• As of December 31, 2025, cash on hand was $337,655, and the accumulated deficit reached $38,871,733.
• Management has concluded there is substantial doubt about the company's ability to continue as a going concern for one year from the financial statement issuance date.
• Liminatus received multiple Nasdaq notices for non-compliance with minimum Market Value of Listed Securities ($50M), Market Value of Publicly Held Shares ($15M), and minimum bid price ($1) rules.
• A public offering in February 2026 raised approximately $3.46 million in net proceeds through the sale of common stock, pre-funded warrants, and common stock purchase warrants.
• The company settled a legal dispute with Clear Street LLC by issuing 4,000,000 shares of common stock in exchange for the cancellation of 805,377 warrants, resolving a $7.5 million default judgment plus interest.

Sentiment

Score: 2

Explanation: StockSavvy.ai views this filing negatively due to significant financial losses, a going concern warning, and multiple Nasdaq non-compliance issues, despite promising preclinical data for its lead candidate.

Positives

• The company's next-generation CD47 monoclonal antibody (IBA101) has shown a key differentiating feature by preferentially binding to immune cells but not red blood cells and platelets, potentially avoiding the anemia and thrombocytopenia issues seen with first-generation CD47 inhibitors.
• Preclinical studies for IBA101, including CMC development and monkey toxicity studies, have been completed, positioning the company for a timely transition into clinical trials.
• IBA101 demonstrated complete tumor suppression in animal models when combined with anti-PD1 antibodies and showed synergistic effects with other immune-oncology therapies (anti-PD-L1, anti-TIGIT blocking antibodies, agonistic anti-4-1BB antibody), indicating broad potential.
• New potential therapeutic applications for the CD47 asset were discovered, including reducing chronic inflammation and inducing weight loss, which could expand its market beyond cancer to age-related diseases like cardiovascular disease and obesity.
• The global market for PD-1/PD-L1 blockades, which CD47 inhibitors are expected to complement, was estimated at $49.5 billion in 2023 and is projected to reach $123.3 billion by 2033, offering significant market penetration potential.
• The company has established a clinical plan with Phase 1 trials for IBA101 monotherapy in advanced solid cancers scheduled for 2026 and combination therapy trials for Stage III NSCLC in 2027.

Negatives

• The company reported a significant increase in net loss, from $3,546,309 in 2024 to $10,206,517 in 2025.
• Cash used in operating activities increased substantially from $1,451,066 in 2024 to $9,963,318 in 2025, indicating a higher cash burn rate.
• Management has concluded that there is substantial doubt about the company's ability to continue as a going concern for one year after the financial statements were issued.
• The company is non-compliant with multiple Nasdaq listing rules, including minimum Market Value of Listed Securities ($50,000,000), Market Value of Publicly Held Shares ($15,000,000), and the minimum bid price ($1 per share).
• A legal settlement with Clear Street LLC resulted in the issuance of 4,000,000 shares of common stock and a $7,360,000 expense in the 2025 financials, reflecting a significant liability.
• The company has an accumulated deficit of $38,871,733 as of December 31, 2025.
• As of December 31, 2025, the company had only $337,655 in cash, which is insufficient to fund operations for twelve months.
• The company has identified material weaknesses in its internal control over financial reporting, specifically a lack of a formalized control environment and inadequate segregation of duties due to staff size.
• The company currently has only one full-time employee (CEO Chris Kim) and relies on advisors and third-party contractors, which may pose operational and control challenges for a public company.

Risks

• Inability to achieve or maintain profitability and generate significant revenue, as the company is pre-clinical stage and has incurred operating losses since inception.
• Inability to manage growth effectively, especially as it transitions to clinical trials and potentially expands its workforce.
• Inability to raise funding on reasonable terms as necessary to develop its products and fund operations, which is critical given the going concern doubt and current cash position.
• Failure to maintain the listing of common stock and warrants on Nasdaq due to non-compliance with MVLS, MVPHS, and Bid Price rules, which could negatively impact liquidity and investor confidence.
• Cybersecurity threats pose significant risks to the integrity of systems and data, with the company currently lacking formalized cybersecurity measures, a dedicated team, or specific protocols.
• The company's intellectual property may not develop into successful commercial products, and there is no assurance that its patent applications will be granted or provide sufficient protection.
• Competition from large pharmaceutical and biotechnology companies in the immuno-oncology market, which could limit market penetration even if products are successful.
• Potential for adverse outcomes in ongoing or future legal proceedings, such as the Sidhu Matter, which could result in significant financial liabilities.
• Reliance on third-party manufacturers for drug substance and product, introducing supply chain and quality control risks.
• The ultimate implementation and impact of the Biologics Price Competition and Innovation Act (BPCIA) and other regulatory exclusivity provisions are subject to significant uncertainty and potential government proposals to reduce exclusivity periods.

Future Outlook

Liminatus Pharma expects to transition its clinical candidate, IBA101, into Phase 1 clinical trials for advanced solid cancers in 2026, with a focus on safety confirmation in South Korea for lung cancer patients. Combination therapy trials for Stage III NSCLC are planned for 2027. The company anticipates needing additional managerial, operational, sales, marketing, financial, and other personnel to implement its development and commercialization plans. Management's plans to address going concern issues include raising additional cash through equity and debt financings, though there is no assurance of success. The company is also actively evaluating additional assets for in-licensing or partnership to broaden its portfolio.

Management Comments

• "Our vision is to develop a broad array of transformative therapies for cancer patients as a leading global biopharmaceutical company."
• "We intend to do this through establishing a leadership position in immune-oncology and by strengthening the differentiation of the next generation anti-CD47 monoclonal antibody from IND enabling studies through to clinical development and broadening the portfolio through in-licensing highly promising and differentiated therapeutic assets."
• "We believe that our leadership teams extensive global experience within the biopharma industry, which spans all stages of development, commercialization and financing of pharmaceutical products, is a key competitive advantage for Liminatus in maximizing the full potential value of its pipeline."
• "We have never paid cash dividends on our Common Stock, and do not expect to pay such dividends in the foreseeable future."
• "We are working diligently to regain compliance with Nasdaq's listing rules. However, there can be no assurance that we will be able to regain compliance within the prescribed time period."
• "Managements plans relating to the above include raising additional cash through equity and debt financings or other arrangements to fund operations. There can be no assurance that the Company will be able to raise adequate capital under acceptable terms, if at all."

Industry Context

StockSavvy.ai notes that Liminatus Pharma operates in the highly competitive and capital-intensive immuno-oncology market, specifically targeting the CD47 pathway. The global market for PD-1/PD-L1 blockades, which CD47 inhibitors are expected to complement, is substantial and projected for significant growth, reaching $123.3 billion by 2033. This provides a large potential market for Liminatus's IBA101. However, the field has seen challenges, as evidenced by Gilead Sciences' acquisition of Forty Seven Inc. and the subsequent termination of Magrolimab's Phase 3 trials due to efficacy and safety concerns (anemia). Liminatus's strategy to develop a 'next-generation' CD47 antibody that avoids red blood cell binding directly addresses a major safety drawback of earlier candidates, potentially offering a significant competitive advantage if successful. The discovery of IBA101's potential in chronic inflammation and weight loss also aligns with broader industry trends exploring existing drug candidates for new indications, as seen with Dr. Irving Weissman's shift to Bitterroot for cardiovascular diseases.

Comparison to Industry Standards

• Liminatus's IBA101 aims to differentiate itself from first-generation CD47 inhibitors like Magrolimab (developed by Forty Seven, acquired by Gilead Sciences) by avoiding red blood cell and platelet binding, which caused anemia and thrombocytopenia in Magrolimab's clinical trials and led to their termination.
• Preclinical studies for IBA101 demonstrated no binding to red blood cells and platelets and no induction of hemolysis, a key safety advantage compared to the issues faced by Magrolimab.
• IBA101 showed complete tumor suppression in animal models when combined with an anti-PD1 antibody, and synergistic activity with other immune checkpoint inhibitors (anti-PD-L1, anti-TIGIT, anti-4-1BB), suggesting a versatile profile for combination therapies, a common strategy employed by major pharma companies like Merck (Pembrolizumab) and AstraZeneca (Durvalumab).
• The discovery of IBA101's potential in reducing chronic inflammation and inducing weight loss in animal studies suggests a broader application scope, similar to the strategic pivot seen with Dr. Irving Weissman's Bitterroot, which is exploring CD47 blockers for cardiovascular diseases after initial cancer setbacks with Forty Seven.

Management Changes

Corporate Governance

Legal Proceedings

• On August 4, 2025, Dr. Someit Sidhu filed a complaint against the company in New York State Supreme Court for breach of contract, alleging failure to pay an advisory fee of $25,000 and a despac success fee of $1,400,000. The company filed a motion to dismiss on December 10, 2025, which is pending.
• On February 6, 2026, the company entered into a settlement and release agreement with Clear Street LLC, agreeing to issue 4,000,000 shares of common stock in exchange for the surrender and cancellation of 805,377 warrants. This settled an action in the United States District Court for the Central District of California and another in the Southern District of New York, where a default judgment of $7,500,000 plus approximately $515,000 in interest had been entered against the company.

Related Party Transactions

• Numerous loans from related parties (Feelux Co., Ltd., Car-Tcellkor, Valetudo Therapeutics LLC, Ewon Comfortech Co., Ltd., Prophase Sciences LLC, Hana Immunotherapeutics, LLC, Amantes LLC) totaling $1,442,500 as of December 31, 2025, with many having been converted into common stock during the Business Combination.
• As of December 31, 2025, $209,586 was due to the company's executive team for compensation under their employment agreements.
• Chris Kim, the CEO, is also the CEO of Viral Gene, Inc., from which the company had a $126,275 loan receivable that was written off as uncollectible in 2025.
• The Business Combination involved significant conversions of related party debt and accrued interest into common stock, totaling $14,797,901.
• The company issued 100 shares of common stock to Chris Kim for an aggregate purchase price of $10 in November 2022, with no consideration received as of the filing date, resulting in a stock subscription receivable.

Stakeholder Impact

• **Shareholders**: Face significant dilution from recent public offerings and warrant exercises, as well as potential future capital raises. The substantial net losses and going concern warning indicate high financial risk. Nasdaq delisting would severely impact liquidity and share price. The Clawback Policy and Insider Trading Policy aim to protect shareholder interests by promoting ethical conduct and accountability.
• **Employees**: The company expects to need additional managerial, operational, sales, marketing, financial, and other personnel, indicating potential job opportunities. However, the going concern doubt poses job security risks. The 2025 Omnibus Equity Incentive Plan aims to attract and retain talent.
• **Customers/Patients**: The development of a next-generation CD47 antibody offers potential for improved cancer therapies with a better safety profile (avoiding anemia) compared to previous candidates, addressing significant unmet medical needs in advanced solid cancers.
• **Creditors**: Related party creditors have seen significant debt converted into equity, and remaining debts are past due but mutually deferred, indicating a flexible but potentially risky repayment structure. Unpaid underwriting fees also represent an outstanding liability.
• **Regulatory Authorities (SEC, Nasdaq)**: The company's non-compliance with Nasdaq listing rules and material weaknesses in internal controls highlight areas of concern for regulatory bodies, requiring diligent remediation efforts.

Next Steps

• Prepare and submit the Investigational New Drug (IND) application for IBA101.
• Initiate Phase 1 clinical trials for IBA101 monotherapy in advanced solid cancers in 2026, focusing on safety confirmation in South Korea for lung cancer patients.
• Initiate Phase 1 clinical trials for IBA101 in combination with Durvalumab or pembrolizumab for Stage III NSCLC in 2027, also in South Korea.
• Conduct additional preclinical animal studies utilizing mouse lung cancer cell lines (e.g., LL/2 expressing human CD47) if requested by the FDA.
• Work diligently to regain compliance with Nasdaq's listing rules (MVLS, MVPHS, and Bid Price) by May 18, 2026, and July 14, 2026, respectively.
• Evaluate the need for additional qualified personnel to support development, commercialization, and public company operations.
• Continue designing formal written policies and procedures regarding internal controls over financial reporting and evaluating the need for additional qualified personnel to address material weaknesses.
• Evaluate additional assets for in-licensing or partnership to broaden the company's portfolio.
• The Board will oversee the development of a cybersecurity risk management framework and approve related policies and strategies.

Key Dates

Recommendation

Liminatus Pharma, Inc. presents an extremely high-risk investment profile. The company is a pre-clinical stage biopharmaceutical firm with no revenue, reporting a significantly widened net loss of over $10 million in 2025 and a substantial accumulated deficit. Management has explicitly stated 'substantial doubt about its ability to continue as a going concern.' Furthermore, the company is non-compliant with multiple critical Nasdaq listing rules (Market Value of Listed Securities, Market Value of Publicly Held Shares, and Bid Price), facing potential delisting. While the next-generation CD47 antibody shows preclinical promise and addresses a key safety issue of prior candidates, the financial instability, severe cash burn, and governance weaknesses (material weaknesses in internal controls, reliance on one full-time employee) overshadow any scientific potential. The recent capital raise of $3.46 million is insufficient to address the magnitude of its financial challenges and ongoing operational needs. A seasoned investor would view these factors as indicative of imminent and severe financial distress, making the stock a strong sell.

Keywords

Liminatus Pharma, Biopharmaceutical, Cancer Therapy, CD47 Antibody, IBA101, Immuno-oncology, Preclinical, Nasdaq Delisting, Going Concern, Public Offering, Non-small Cell Lung Cancer, NSCLC, Monoclonal Antibody, Clinical Trials, Chronic Inflammation, Obesity, Intellectual Property, Warrants, SEC Filing, 10-K