20-F: CytoMed Therapeutics Reports 2025 Losses Amid Clinical Trials

CytoMed Therapeutics Limited, a clinical-stage biopharmaceutical company, reported increased losses in 2025 as it advances multiple cell-based immunotherapy product candidates through preclinical and Phase I clinical trials.

Summary

• CytoMed Therapeutics is a clinical-stage biopharmaceutical company focused on allogeneic, off-the-shelf cell-based immunotherapies for human cancers and degenerative diseases.
• The company reported accumulated losses of S$18.83 million as of December 31, 2025, up from S$14.85 million in 2024.
• Net loss for the financial year ended December 31, 2025, was S$4.00 million, an increase from S$2.52 million in 2024.
• Research expenses increased to S$2.22 million in 2025 from S$1.91 million in 2024, driven by higher consumable and clinical trial expenses.
• The ANGELICA Trial (Phase I clinical trial for CTM-N2D in solid tumors) is ongoing, with dose level 1 completed and dose level 2 underway; patient recruitment is anticipated to continue in 2026.
• The company commenced revenue generation from private blood banking services in 2024, reaching S$324,387 in 2025.
• Acquired assets of Cellsafe International Sdn Bhd (In Liquidation) in late 2024, including a private blood bank license, cryopreservation equipment for over 12,000 cord blood units, and two freehold properties.
• Entered into a Business and Research Collaboration Agreement (BRCA) with SunAct Cancer Institute Private Limited (SUNACT) on December 30, 2024, to conduct clinical trials for CTM-GDT in South Asia and Dubai.
• Submitted a drug master file to the U.S. FDA for CTM-GDT and intends to pursue an Investigational New Drug (IND) application.
• The Know-How License agreement with ATPL for GMP-compatible reprogramming of human blood cells was terminated on March 27, 2025.
• Issued 130,431 ordinary shares under the 2023 Equity Incentive Plan and 63,281 ordinary shares as share-based compensation to affiliates in 2025.
• Raised S$283,094 in net proceeds from the At-the-Market (ATM) offering program in 2025, with an additional US$6,000 raised in January 2026.
• The company's cash and bank balances decreased to S$2.10 million as of December 31, 2025, from S$4.97 million in 2024.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this filing with a negative sentiment due to increasing losses, significant cash burn, and delays in key preclinical and clinical milestones, despite some positive strategic developments and initial revenue generation. The termination of a key license also adds to the concerns.

Positives

• Successful initiation and ongoing progress of the ANGELICA Trial (Phase I for CTM-N2D) with dose level 1 completed and dose level 2 underway.
• Received co-funding support for the ANGELICA Trial from the MOH Singapore through the National Medical Research Council (NMRC) Office and MOH Holdings Pte Ltd.
• Commenced revenue generation from private blood banking services, reaching S$324,387 in 2025, indicating a new income stream.
• Strategic acquisition of Cellsafe International Sdn Bhd's assets, including a private blood bank license and cryopreservation equipment for over 12,000 cord blood units, expanding service offerings.
• Established a Business and Research Collaboration Agreement (BRCA) with SUNACT for clinical trials of CTM-GDT in South Asia and Dubai, indicating international expansion.
• Submission of a drug master file to the U.S. FDA for CTM-GDT, signaling intent to pursue IND application in a major market.
• Research income increased by 23.6% to S$536,461 in 2025, reflecting higher demand from researchers and institutions.
• The company maintains an in-house cGMP Facility in Malaysia, which has been audited by NPRA and deemed to have a satisfactory level of compliance, supporting clinical product supply and cost-effectiveness.
• Obtained an Enterprise Development Grant (EDG) from Enterprise Singapore to fund the R&D of the CTM-NK project till the pre-clinical stage.

Negatives

• Accumulated losses increased to S$18.83 million in 2025, up from S$14.85 million in 2024, reflecting continued unprofitability.
• Net loss for 2025 was S$4.00 million, an increase from S$2.52 million in 2024, indicating worsening financial performance.
• Cash and bank balances significantly decreased to S$2.10 million in 2025 from S$4.97 million in 2024, raising liquidity concerns.
• Interest income declined by 61.0% to S$123,898 in 2025 due to fixed deposit withdrawals, impacting non-operating income.
• The Know-How License agreement with ATPL for GMP-compatible reprogramming of human blood cells was terminated on March 27, 2025, potentially impacting iPSC-based technology development.
• The DCGI advised that the CTM-GDT study in India be conducted under the IND framework rather than as an academic clinical trial, requiring a feasibility assessment for manufacturing infrastructure and potentially delaying the trial.
• The development of ADI-270 by competitor Adicet Bio, Inc. was discontinued in July 2025, highlighting the high failure rate in clinical development for similar therapies.
• The company has no products approved for commercial sale and expects to incur significant losses for the foreseeable future, dependent on future funding.
• The current cGMP Facility may not be sufficient for large-scale commercial manufacture, requiring additional capital expenditure or outsourcing in the future.
• The company has not yet developed a validated methodology for freezing and thawing large quantities of product candidates without damage, which may limit adoption and standardization for overseas distribution.

Risks

• Lack of long operating history and no products approved for commercial sale, leading to expected significant losses and substantial doubt about going concern.
• Requirement for additional capital, which may cause dilution to shareholders, restrict operations, or necessitate relinquishing rights to product candidates.
• Acquisitions or strategic collaborations are capital intensive, may dilute equity, incur debt, or assume contingent liabilities.
• Business operations are subject to the effects of pandemics, health epidemics, and outbreaks of infectious diseases, potentially causing delays in clinical trials, supply chain disruptions, and increased costs.
• Success depends on obtaining regulatory approval and commercialization of novel cell-based product candidates (CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC, CTM-NK), which are new and unproven technologies.
• Pre-clinical studies may experience delays or fail to progress to clinical trials, adversely affecting regulatory approvals and commercialization timelines.
• Results of pre-clinical studies and early-stage clinical trials may not be indicative of future results in later-stage trials, leading to potential failures.
• Clinical trials involve lengthy, costly processes with uncertain outcomes, subject to delays from regulatory agencies, patient enrollment difficulties, and manufacturing challenges.
• Product candidates may have undesirable side effects (e.g., cytokine release syndrome, neurotoxicity, GvHD) leading to trial delays, discontinuation, or restrictive labeling.
• Public perception of cell-based immuno-oncology therapies may negatively impact the company and product candidates, affecting patient enrollment and market acceptance.
• Failure to identify or develop other product candidates or capitalize on greater commercial opportunities due to limited resources.
• Reliance on third parties (CROs, CMOs, medical professionals) for clinical trials, leading to less direct control and potential delays or compromised data if they fail to perform satisfactorily.
• Intense and dynamic competition from well-funded biopharmaceutical companies and research institutions in the immunotherapy field.
• Need to increase organizational size and manage growth effectively, including hiring and retaining skilled personnel, which may be challenging.
• Substantial liabilities from potential product liability lawsuits related to clinical trials or commercialized products, with limited insurance coverage.
• Use of biohazardous materials in R&D and manufacturing, subject to strict laws and regulations, with risks of contamination, environmental damage, and operational cessation.
• Exposure to information technology and cybersecurity risks, including data breaches and service disruptions, potentially leading to penalties and adverse business impacts.
• cGMP Facility operations and manufacturing may be affected by natural disasters or non-compliance with Malaysian regulatory standards, leading to operational cessation or license loss.
• Current cGMP Facility may be insufficient for large-scale commercial manufacturing, requiring significant additional investment or outsourcing.
• Manufacturing process complexity, including reliance on key suppliers for reagents with short expiration periods, poses risks of production delays, product loss, or contamination.
• Reliance on the storage of cell banks (engineered K562 cells, peripheral blood mononuclear cells); damage or loss would cause clinical trial delays and significant expenses.
• Delays in obtaining renewal of regulatory approvals for the cGMP Facility and licenses could hinder development plans and revenue generation.
• Optimal donor and manufacturing parameters for product candidates may not be definitively established, limiting optimization and ability to address safety/efficacy issues.
• Lack of a validated methodology for freezing and thawing large quantities of product candidates without damage, limiting storage and overseas distribution capabilities.
• Need for updated and validated protocols for commercial-scale expansion and manufacturing of gamma delta T cells for pivotal trials and commercialization.
• Current tensions in international trade and rising international political tensions may adversely affect business, financial condition, and results of operations, especially if expanding internationally.
• Difficulty and cost in protecting proprietary rights, including patents and trade secrets, with risks of competitors developing similar products or patent challenges.
• Dependence on licensed intellectual property; loss of rights could prevent development or commercialization of product candidates.
• Uncertainty regarding the issuance and scope of patents from licensed patent applications, potentially diminishing competitive advantage.
• Limited life of patent protection; expiration could lead to competition from biosimilar medications.
• Need to license intellectual property from third parties, which may not be available on commercially reasonable terms or at all.
• Risk of infringing intellectual property rights of others, leading to costly litigation, delays, or inability to commercialize products.
• Difficulty in obtaining and enforcing intellectual property rights globally, especially in jurisdictions with less extensive protection.
• Failure to prevent disclosure of trade secrets and other proprietary information, diminishing technology value.
• Claims that employees or consultants have wrongfully used or disclosed alleged trade secrets.
• Limited market opportunities for product candidates, especially if approved only for later-line therapies or if patient populations are smaller than anticipated.
• Commercial success depends on market acceptance by physicians, patients, and third-party payors, which is uncertain for novel cell therapies.
• Uncertainty regarding insurance coverage and reimbursement status for newly approved products, potentially hindering market access due to high costs.
• Healthcare reform initiatives and other administrative/legislative proposals may affect business, leading to increased regulation or pricing pressure.
• Obtaining marketing approval in one jurisdiction does not guarantee success in others, with varying regulatory requirements and potential for additional risks in international commercialization.
• No prior business experience in India and unfamiliarity with Indian laws and regulations, relying on partners for compliance.
• Risk of non-compliance with regulatory standards for manufacturing quality products in India, potentially leading to penalties or rejection of product approval applications.
• Unforeseen financial and operational difficulties from the acquisition of CellSafe International Sdn. Bhd. (In-Liquidation) assets, including integration challenges and competition in the cord blood banking market.
• Limited suppliers for specialized equipment and consumables for cord blood stem cell banking, risking supply disruptions and increased costs.
• Regulatory framework for cord blood stem cell banking in Malaysia is still developing, with potential for stricter oversight and increased compliance costs.
• Potential for negative publicity about non-compliance of other cord blood stem cell banks to adversely affect consumer confidence in the company's services.
• Inability to protect systems and data from cybersecurity risks, especially sensitive personal and medical data, leading to potential breaches and penalties.
• Failure in performance of cryopreservation storage facility or systems could harm business and reputation, with inadequate insurance coverage.
• Active trading market for Ordinary Shares may not continue, leading to significant price fluctuations and potential loss of investment.
• Future capital raises may cause significant dilution to existing shareholders.
• Share price volatility due to various factors, including clinical trial results, competitive products, and general economic conditions.
• Risk of securities class action litigation following periods of share price volatility.
• Decline in share price if securities analysts do not publish research or publish negative reports.
• Sales of substantial number of Ordinary Shares by existing shareholders could depress market price.
• Principal shareholders, officers, and directors exert significant control, potentially limiting influence of other shareholders.
• Reliance on foreign private issuer status and emerging growth company exemptions, which may afford less protection to U.S. shareholders and incur additional costs upon loss of status.
• Ineffective internal control over financial reporting could lead to inaccurate financial reports and loss of investor confidence.
• Increased costs and management time due to operating as a public company.
• Changes to, or interpretations of, financial accounting standards (IFRS) may affect results of operations.
• Limitations on the ability to use loss carryovers and certain other tax attributes due to ownership changes.
• Remote likelihood of paying cash dividends; investors must rely on share price appreciation.
• Incorporated in Singapore, shareholders may have more difficulty protecting interests compared to U.S. corporations.
• Difficulty in transferring shares due to Singapore law and company constitution restrictions.
• Difficulty in enforcing U.S. judgments against the company or its directors/officers in Singapore.
• Issuance of new Ordinary Shares may dilute existing shareholders' percentage ownership.
• Subject to Malaysian laws and regulations, which are uncertain and subject to change, potentially increasing compliance costs or restricting operations.
• Exposure to political, economic, and social conditions in Malaysia, which could adversely affect business.
• Subject to foreign exchange legislation and regulations in Malaysia, potentially restricting repatriation of funds or foreign currency borrowing.
• Regulatory risks related to environmental hazards, production safety, and accidents in Malaysia, leading to legal proceedings or license revocation.
• Compliance with PDPA Malaysia and other data privacy laws entails significant expenses and challenges with cross-border data transfers.
• Regulations governing foreign workers in Malaysia may limit hiring or increase labor costs.
• Mechanism for enforcement of foreign judgments in Malaysia is limited to certain jurisdictions, making enforcement of non-monetary or non-reciprocating country judgments difficult.

Future Outlook

The company expects to continue incurring significant losses for the foreseeable future as it advances its research and development activities, particularly the ANGELICA Trial for CTM-N2D, research collaboration with Universiti Malaya, and preclinical development of other product candidates. Future capital requirements will depend on the scope, timing, and costs of clinical trials, regulatory review, manufacturing, commercialization, intellectual property maintenance, and potential acquisitions. The company anticipates funding operations through its ATM offering, equity and debt financings, and strategic partnerships, acknowledging that obtaining sufficient financing on favorable terms is uncertain.

Management Comments

• "We believe that the current development of CD19-targeting CAR-T cells in treating B-cell malignancies signifies that cellular immunotherapy is becoming one of the pillars in cancer care."
• "We believe that our uniquely designed platform technologies and product development strategies are expected to strengthen our capability to achieve such goal [to develop novel off-the-shelf cell therapies to improve the quality of life of cancer patients and to increase their overall survival]."
• "We believe that our in-house cGMP manufacturing capability will enable us to maintain not only the quality and availability of cell therapy products, which is crucial for our clinical success, but also allow us to manufacture cell therapy products more cost-effectively, which will be crucial for commercial viability."
• "Our vision is to be among the pioneers of allogeneic cellular immunotherapy treatment for cancer, with a focus on addressing the significant unmet medical needs in emerging markets within South-east Asia."
• "We believe the U.S. offers the scientific depth, clinical development experience and access to capital required to accelerate the advancement of our cellular therapy programs."
• "We believe that the Company is well positioned, with the necessary expertise, experience and resources to capture these emerging opportunities."
• "We expect to continue incurring losses for the foreseeable future as we advance our research and development activities."

Industry Context

StockSavvy.ai notes that CytoMed Therapeutics operates in the highly competitive and capital-intensive biopharmaceutical industry, specifically in the emerging field of cell-based immunotherapies. The company's focus on 'off-the-shelf' allogeneic therapies addresses a key limitation of current autologous CAR-T treatments (cost, personalization, manufacturing complexity). The increasing regulatory frameworks in Singapore and Malaysia for Cell and Gene Therapy Products (CGTPs) reflect a growing acceptance and institutional support for this novel medical science in Southeast Asia, as evidenced by Singapore's ACTRIS initiative. However, the industry is characterized by high R&D costs, lengthy clinical trials, and significant regulatory hurdles, with few cell-based cancer therapies having achieved commercial approval globally, and none for gamma delta T cell-based therapy by HSA. The discontinuation of competitor ADI-270 highlights the inherent risks and high failure rates in this innovative but challenging sector.

Comparison to Industry Standards

• CytoMed's CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC, and CTM-NK product candidates are designed to be allogeneic and 'off-the-shelf,' contrasting with the highly personalized and expensive autologous CAR-T therapies like Novartis' Kymriah (U.S.$475,000) and Gilead Sciences' Yescarta (U.S.$373,000), which are approved for specific B-cell malignancies.
• While Kymriah and Yescarta target CD19, CytoMed's CTM-N2D targets NKG2DLs, aiming for a broader range of cancers and lower risk of cancer escape due to multiple antigen recognition, a potential advantage over single-antigen targeting CAR-T therapies.
• The company's iPSC-gdNKT platform, utilizing induced pluripotent stem cells, aims to overcome limitations of patient/donor blood cell availability and variability, a challenge faced by traditional CAR-T manufacturing.
• Competitors in allogeneic CAR-T therapies include Allogene Therapeutics, Inc., Astellas Pharma Inc., Bristol-Myers Squibb, Celyad Oncology SA, Fate Therapeutics, Inc., Gilead Sciences, Inc., and Novartis International AG.
• In the gamma delta T cell therapy space, Acepodia Biotech, Inc. announced a Phase 1 clinical trial for ACE1831 (anti-CD20 armed allogeneic gamma delta T-cell therapy) in May 2023, and TC BioPharm (Holdings) PLC announced preliminary efficacy data for TCB008 in February 2025, indicating a competitive landscape for CytoMed's CTM-GDT.
• For iPSC-derived immune cells, Fate Therapeutics, Inc. initiated a Phase I clinical trial for a HER2-targeting CAR T-cell product in January 2024, and Takeda-CiRA joint program is in preclinical stage, positioning CytoMed's iPSC-gdNKT in an evolving competitive field.
• In natural killer cell therapy, competitors include Artiva Biotherapeutics, Inc., Glycostem Therapeutics B.V., Indapta Therapeutics, Celularity, Gamida Cell, Ingenium Therapeutics, SMT Bio co Ltd, Alphageneron Pharmaceuticals & MultiImmune, Wugen, and NKGen Biotech, indicating a crowded market for CytoMed's CTM-NK.
• The discontinuation of Adicet Bio, Inc.'s ADI-270 for ccRCC in July 2025, shifting focus to ADI-212 for prostate cancer, illustrates the high attrition rate and strategic pivots common in early-stage cell therapy development.
• No approved Phase III trial for gamma delta T cell-based cancer immunotherapy is known as of the filing date, highlighting the early stage of this specific therapeutic modality across the industry.

Management Changes

Corporate Governance

Legal Proceedings

• As of the date of the annual report, the company has not been subject to any legal or arbitration proceedings that may have significant effects on its financial position or profitability.

Related Party Transactions

• Disposed of entire 20.0% equity interest in Landmark Medical Centre Sdn Bhd (LMC) on December 18, 2025, for RM1.65 million (S$517,440), recognizing a gain of S$294,236. Dr. Lucas LUK Tien Wee, a former Director and current Chief Clinical Officer, was a shareholder and CEO of LMC.
• Received research income from LMC: S$183,518 in 2023, S$115,277 in 2024, S$24,167 in 2025, and S$3,584 from January 1, 2026, to the filing date.
• EP Capital Inc., wholly owned by Chairman and Director Mr. CHOO Chee Kong, subscribed for 20,000 ordinary shares in subsidiary LongevityBank Pte Ltd for S$46,565 on October 4, 2024.
• EP Capital further subscribed 40,000 ordinary shares in LongevityBank for S$200,000 on December 12, 2025.
• Loan to a related party (an immediate family member of a key management personnel) which is unsecured, interest-free, and repayable over 2 years via 24 monthly installments, included in non-current other receivables as of December 31, 2025.

Stakeholder Impact

• **Shareholders:** Face increased dilution risk from ongoing ATM offerings and potential future equity raises to fund operations and R&D. The significant accumulated losses and negative cash flow from operations indicate a high-risk investment. The concentration of ownership by principal shareholders, officers, and directors (28.26%) may limit the influence of other shareholders. The stock price is subject to high volatility due to clinical trial outcomes and market factors.
• **Employees:** Benefit from share-based compensation (S$309,248 in 2025) and the 2023 Equity Incentive Plan, designed to attract and retain talent. However, the company's financial losses and reliance on future funding could pose risks to job security if funding is not secured.
• **Customers (Private Blood Banking):** Benefit from expanded services through the acquisition of Cellsafe International's assets, offering cryostorage for various cell types. However, negative publicity in the broader cord blood banking industry (e.g., Cordlife incident) could erode public trust and impact customer acquisition.
• **Research Partners (e.g., National University Hospital Singapore, Universiti Malaya, SUNACT):** Engaged in collaborative clinical trials and research, benefiting from CytoMed's product candidates and scientific expertise. Delays in regulatory approvals or manufacturing could impact the progress of these collaborations.
• **Regulatory Authorities (HSA, NPRA, U.S. FDA, DCGI):** The company's activities are under close scrutiny, with ongoing CTA/IND applications and facility audits. Compliance failures could lead to sanctions, delays, or loss of licenses, impacting public health and regulatory oversight.

Next Steps

• Continue patient recruitment for dose level 2 of the ANGELICA Trial (Phase I for CTM-N2D) in 2026.
• Commence pre-clinical studies for iPSC-gdNKT after Q2 2026.
• Pursue an Investigational New Drug (IND) application with the U.S. FDA for CTM-GDT.
• Conduct a feasibility assessment for establishing required manufacturing infrastructure to support IND submission for CTM-GDT in India.
• Target commencement of a FIH Phase I clinical trial for CTM-GDT in Malaysia with Universiti Malaya in the second half of 2026.
• Sengkang General Hospital to submit an application to the Institutional Review Board (IRB) to initiate a Phase I clinical trial evaluating CTM-MSC for osteoarthritis.
• Continue R&D of CTM-NK project till the pre-clinical stage, supported by an Enterprise Development Grant.
• Build an ISO-standard laboratory for IPSC Depository to further enhance capabilities.
• Explore enabling technologies to further enhance healthy donor blood cell and iPSC-based platforms for novel cell therapy.
• Explore opportunities with potential partners from A*STAR to further develop proprietary manufacturing capabilities.

Key Dates

Recommendation

CytoMed Therapeutics is in a high-risk, high-reward sector. While the company is making progress in clinical trials and expanding its service offerings, the significant and increasing losses, substantial cash burn, and reliance on future capital raises present considerable financial risks. The termination of a key license and regulatory delays in India are notable setbacks. However, the strategic collaborations, grant funding, and the potential of its novel allogeneic cell therapies offer long-term upside. Given the early stage of development and the inherent uncertainties, a 'hold' recommendation is appropriate for investors with a high-risk tolerance who are willing to monitor clinical progress and financial stability closely. A 'buy' would be premature given the current financial state and 'sell' would disregard the potential of its innovative pipeline.

Keywords

Cell Therapy, Immunotherapy, Cancer Treatment, Degenerative Diseases, Biopharmaceutical, Clinical Stage, CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC, CTM-NK, CAR-T, Gamma Delta T Cells, Natural Killer Cells, Induced Pluripotent Stem Cells, cGMP Facility, Clinical Trials, Regulatory Approval, Singapore, Malaysia, Oncology, Regenerative Medicine, Cord Blood Banking, SEC Filing, 20-F