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CytoMed Therapeutics Ltd

CytoMed Therapeutics LtdGDTC決算レポート

Nasdaq

CytoMed Therapeutics Ltd is a clinical-stage biopharmaceutical company focused on developing innovative allogeneic chimeric antigen receptor (CAR-T) cell therapies for treating hematological malignancies and solid tumors. It primarily serves global oncology patient populations and advances candidates targeting unmet medical needs in the immuno-oncology segment.

What changed in CytoMed Therapeutics Ltd's 20-F — 2024 vs 2025

Top changes in CytoMed Therapeutics Ltd's 2025 20-F

301 paragraphs added · 261 removed · 217 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

44 edited+7 added−4 removed753 unchanged
Our senior management is crucial for our business and operations. The loss of any of our senior management could delay, hinder or prevent the successful development of our product pipeline, initiation or completion of our planned clinical trials or the commercialization of our future product candidates. We have employment and/or service agreements with all of our senior management team members.
Our senior management is crucial for our business and operations. The loss of any of our senior management could delay, hinder or prevent the successful development of our product pipeline, initiation or completion of our planned clinical trials or the commercialization of our future product candidates. We have employment and/or service agreements with all our senior management team members.
In addition, we anticipate a substantial increase in our expenses if, and as, we seek to: ● initiate clinical development of our proprietary product candidates, CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC; ● advance additional product candidates to clinical trials, including CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC; ● discover and develop additional product candidates; ● establish and validate our own clinical-scale and commercial-scale cGMP facilities; ● initiate or develop a MAA, or equivalent in the relevant countries, for CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC and/or seek marketing approvals for any of our other product candidates that successfully complete clinical trials; ● engage, on an as needed basis, third-party contractors including CROs and CMOs to conduct clinical trials; ● maintain, expand and protect our intellectual property portfolio; ● acquire or in-license other product candidates and technologies; ● incur additional costs associated with operating as a public company; ● Explore new partnerships locally, within the region and globally; and ● increase our employee headcount and related expenses to support these activities.
In addition, we anticipate a substantial increase in our expenses if, and as, we seek to: ● initiate clinical development of our proprietary product candidates, CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK; ● advance additional product candidates to clinical trials, including CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK; ● discover and develop additional product candidates; ● establish and validate our own clinical-scale and commercial-scale cGMP facilities; ● initiate or develop a MAA, or equivalent in the relevant countries, for CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK and/or seek marketing approvals for any of our other product candidates that successfully complete clinical trials; ● engage, on an as needed basis, third-party contractors including CROs and CMOs to conduct clinical trials; ● maintain, expand and protect our intellectual property portfolio; ● acquire or in-license other product candidates and technologies; ● incur additional costs associated with operating as a public company; ● Explore new partnerships locally, within the region and globally; and ● increase our employee headcount and related expenses to support these activities.
Severe adverse events associated with our product candidates, CTM-N2D, iPSC-gdNKT and CTM-GDT may also develop, since targeting NKG2DLs is not yet a well-characterized modality. NKG2D targets multiple ligands, and the landscape of ligand expression is currently not fully understood. For example, there are risks that NKG2DLs may be expressed on either known or an as-yet-underappreciated population of healthy cells.
Severe adverse events associated with our product candidates, CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK may also develop, since targeting NKG2DLs is not yet a well-characterized modality. NKG2D targets multiple ligands, and the landscape of ligand expression is currently not fully understood. For example, there are risks that NKG2DLs may be expressed on either known or an as-yet-underappreciated population of healthy cells.
If any of our product candidates encounter safety or efficacy issues, developmental delays or regulatory issues or other roadblocks, it could impact the development plans for our other product candidates. 4 Our research on utilizing CTM-N2D, CTM-GDT and iPSC-gdNKT to treat cancer; and CTM-MSC to treat degenerative diseases is novel, and we must overcome significant challenges such as obtaining required regulatory approvals in order to develop, commercialize and manufacture our product candidates.
If any of our product candidates encounter safety or efficacy issues, developmental delays or regulatory issues or other roadblocks, it could impact the development plans for our other product candidates. 4 Our research on utilizing CTM-N2D, CTM-GDT, iPSC-gdNKT and CTM-NK, to treat cancer; and CTM-MSC to treat degenerative diseases is novel, and we must overcome significant challenges such as obtaining required regulatory approvals in order to develop, commercialize and manufacture our product candidates.
Although some of our employees have prior exposure to clinical trials, regulatory compliance and cGMP manufacturing, we have not previously completed any clinical trials or submitted a marketing approval application to HSA, or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC will be successful in clinical trials or receive the requisite regulatory approvals for the development, commercialization and marketing of CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC.
Although some of our employees have prior exposure to clinical trials, regulatory compliance and cGMP manufacturing, we have not previously completed any clinical trials or submitted a marketing approval application to HSA, or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK will be successful in clinical trials or receive the requisite regulatory approvals for the development, commercialization and marketing of CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK.
Even if we are able to successfully freeze and CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC in large quantities, we will also need to develop a cost-effective and reliable distribution and logistics network, which we may be unable to accomplish. 18 Furthermore, we have not yet demonstrated long-term stability of cryopreserved CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC and therefore are not certain if we will be able to store the cryopreserved cells for extended periods of time.
Even if we are able to successfully freeze and CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK in large quantities, we will also need to develop a cost-effective and reliable distribution and logistics network, which we may be unable to accomplish. 18 Furthermore, we have not yet demonstrated long-term stability of cryopreserved CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK and therefore are not certain if we will be able to store the cryopreserved cells for extended periods of time.
The processes and requirements imposed by HSA and/or other relevant regulatory authorities in multiple jurisdictions may cause delays and additional costs in obtaining approvals for marketing authorization for our product candidates. Because our CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC products are novel, and cell-based therapies are relatively new, regulatory agencies may lack the necessary experience to assess our product candidates.
The processes and requirements imposed by HSA and/or other relevant regulatory authorities in multiple jurisdictions may cause delays and additional costs in obtaining approvals for marketing authorization for our product candidates. Because our CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK products are novel, and cell-based therapies are relatively new, regulatory agencies may lack the necessary experience to assess our product candidates.
If, for any reason in our CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC clinical studies, we damage and/or lose the starting material for a manufactured product for any of our patients at any point in the process, the manufacturing process for that patient would need to be repeated from the beginning and the resulting delay could require restarting the manufacturing process, or could result in such patient withdrawing from our clinical trial.
If, for any reason in our CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK clinical studies, we damage and/or lose the starting material for a manufactured product for any of our patients at any point in the process, the manufacturing process for that patient would need to be repeated from the beginning and the resulting delay could require restarting the manufacturing process, or could result in such patient withdrawing from our clinical trial.
Reflecting this, Singapore set up a national agency in April 2020 known as ACTRIS comprised of, inter alia , all the national universities, hospitals, research institutions and funding agencies in Singapore. Our R&D efforts are focused on utilizing CTM-N2D, iPSC-gdNKT and CTM-GDT as immunotherapies for cancers, and CTM-MSC for degenerative diseases.
Reflecting this, Singapore set up a national agency in April 2020 known as ACTRIS comprised of, inter alia , all the national universities, hospitals, research institutions and funding agencies in Singapore. Our R&D efforts are focused on utilizing CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK as immunotherapies for cancers, and CTM-MSC for degenerative diseases.
Our manufacturing processes for CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC depend on the use of cell culture vessel, and other reagents, some of which might only be available from certain key suppliers. In addition, some of these reagents, at the time of procurement, typically expire after approximately four to six months.
Our manufacturing processes for CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK depend on the use of cell culture vessel, and other reagents, some of which might only be available from certain key suppliers. In addition, some of these reagents, at the time of procurement, typically expire after approximately four to six months.
We must be able to overcome these challenges in order for us to develop, manufacture and commercialize our product candidates utilizing CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC in each geographical market. As such, we remain open to exploring the possibility of conducting clinical trials in other countries.
We must be able to overcome these challenges in order for us to develop, manufacture and commercialize our product candidates utilizing CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK in each geographical market. As such, we remain open to exploring the possibility of conducting clinical trials in other countries.
Any delay in obtaining, or inability to obtain, requisite regulatory approvals will delay or hinder our ability to successfully commercialize CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC. This may have a material and adverse impact on our business, financial condition, results of operations and growth prospects.
Any delay in obtaining, or inability to obtain, requisite regulatory approvals will delay or hinder our ability to successfully commercialize CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK. This may have a material and adverse impact on our business, financial condition, results of operations and growth prospects.
If we are unable to develop a validated method of freezing CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC for shipping purposes, our ability to promote adoption and standardization of our products candidates, as well as achieve economies of scale by centralizing our production facility, will be limited.
If we are unable to develop a validated method of freezing CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK for shipping purposes, our ability to promote adoption and standardization of our products candidates, as well as achieve economies of scale by centralizing our production facility, will be limited.
Until and unless we can achieve substantial revenue from our products to offset our expenses, we expect to finance our operations through the proceeds of our Offering, a combination of equity offerings and debt financings, and potentially through additional license and development agreements or strategic partnerships with third parties.
Until and unless we can achieve substantial revenue from our products to offset our expenses, we expect to finance our operations through the proceeds of our ATM offering, a combination of equity offerings and debt financings, and potentially through additional license and development agreements or strategic partnerships with third parties.
Our current cGMP Facility may not be sufficient to handle the large-scale commercial manufacture and production of product candidates As of the date of this annual report, we are clinical stage biopharmaceutical company with four product candidates: CTM-N2D, CTM-GDT, iPSC-gdNKT and CTM-MSC.
Our current cGMP Facility may not be sufficient to handle the large-scale commercial manufacture and production of product candidates As of the date of this annual report, we are clinical stage biopharmaceutical company with four product candidates: CTM-N2D, CTM-GDT, iPSC-gdNKT, CTM-MSC and CTM-NK.
Due to various reasons (including the foregoing), we have not yet established the long-term stability of our cryopreserved CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC and we may not be able to commercialize CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC on a large scale or in a cost-effective manner.
Due to various reasons (including the foregoing), we have not yet established the long-term stability of our cryopreserved CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK and we may not be able to commercialize CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK on a large scale or in a cost-effective manner.
Future clinical trials that we conduct, as well as any potential commercialization of our product candidates when approved, will depend on the reliability, safety and efficacy of our processes for expanding, modifying and manufacturing CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC at scale.
Future clinical trials that we conduct, as well as any potential commercialization of our product candidates when approved, will depend on the reliability, safety and efficacy of our processes for expanding, modifying and manufacturing CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK at scale.
We currently are unable to ascertain whether CTM-N2D, iPSC-gdNKT and CTM-GDT will be safe for use in humans and whether CTM-N2D, iPSC-gdNKT and CTM-GDT will demonstrate any anti-cancer activity. Subsequently, we plan to conduct additional clinical trials depending on the anti-cancer activity we note in the initial clinical trials.
We currently are unable to ascertain whether CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK will be safe for use in humans and whether CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK will demonstrate any anti-cancer activity. Subsequently, we plan to conduct additional clinical trials depending on the anti-cancer activity we note in the initial clinical trials.
We have not yet developed a validated method of freezing and thawing CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC, which can be frozen and thawed in smaller quantities, in large quantities without damage, in a cost-efficient manner and without degradation over time.
We have not yet developed a validated method of freezing and thawing CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK, which can be frozen and thawed in smaller quantities, in large quantities without damage, in a cost-efficient manner and without degradation over time.
Our efforts to scale up production of our CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC in anticipation of future clinical trials or commercialization may reveal, an inability to overcome biology or may otherwise encounter challenges, including scrutiny from regulatory authorities.
Our efforts to scale up production of our CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK in anticipation of future clinical trials or commercialization may reveal, an inability to overcome biology or may otherwise encounter challenges, including scrutiny from regulatory authorities.
In addition, some of the reagents that we use may be restricted by limited use label licenses and may be for research use and not for commercial application of any kind. We may need to replace certain reagents in order for us to commercialize our products in the future.
In addition, some of the reagents that we use may be restricted by limited use label licenses and may be for research use and not for commercial application of any kind. We may need to replace certain reagents for us to commercialize our products in the future.
We have not yet developed a validated methodology of freezing and thawing large quantities of CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC product candidates, which may be required for the storage and overseas distribution of our product candidates.
We have not yet developed a validated methodology of freezing and thawing large quantities of CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK product candidates, which may be required for the storage and overseas distribution of our product candidates.
We cannot assure that CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC will be safe and effective or will obtain the requisite approvals and licenses for commercialization, on a timely basis or at all.
We cannot assure that CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK will be safe and effective or will obtain the requisite approvals and licenses for commercialization, on a timely basis or at all.
Therefore, such cells may also be targeted by CTM-N2D, iPSC-gdNKT and CTM-GDT and lead to adverse events of unknown frequency and severity. Such adverse events may cause delays in completion of our clinical programs.
Therefore, such cells may also be targeted by CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK and lead to adverse events of unknown frequency and severity. Such adverse events may cause delays in completion of our clinical programs.
RISKS RELATED TO OUR BUSINESS IN THE BIOPHARMACEUTICAL INDUSTRY Our business depends upon the success of our CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC product candidates in obtaining regulatory approval and being commercialized .
RISKS RELATED TO OUR BUSINESS IN THE BIOPHARMACEUTICAL INDUSTRY Our business depends upon the success of our CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK product candidates in obtaining regulatory approval and being commercialized .
Based on publicly disclosed information, in May 2023 Acepodia Biotech, Inc. announced first patient dosed in their phase 1 clinical trial of an anti-CD20 armed allogeneic gamma delta T-cell therapy to treat patients with Non-Hodgkin’s Lymphoma, as well as FDA Clearance of Investigational New Drug (IND) Application for a First-in-Class Allogeneic Anti-EGFR Cell Therapy.
Based on publicly disclosed information, in May 2023 Acepodia Biotech, Inc. announced first patient dosed in their phase 1 clinical trial of an anti-CD20 armed allogeneic gamma delta T-cell therapy (ACE1831) to treat patients with Non-Hodgkin’s Lymphoma, as well as FDA Clearance of Investigational New Drug (IND) Application for a First-in-Class Allogeneic Anti-EGFR Cell Therapy (ACE2016).
Such regulatory delays may thereby increase our development costs and cause further delays in the commercialization of our CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC products.
Such regulatory delays may thereby increase our development costs and cause further delays in the commercialization of our CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK products.
Even if we are able to replace any raw materials or consumables with alternatives, such alternatives may be more expensive, result in lower yields or not be as suitable for our purposes. In addition, some of the raw materials that we use are complex materials, which is likely to be harder to obtain substitutes for.
Even if we can replace any raw materials or consumables with alternatives, such alternatives may be more expensive, result in lower yields or not be as suitable for our purposes. In addition, some of the raw materials that we use are complex materials, which is likely to be harder to obtain substitutes for.
Manufacturing our product candidates involves harvesting blood cells from a donor, isolating the gamma delta T cells, activating and expanding the gamma delta T cells, introducing a mRNA to be expressed on the gamma delta T cells, fill and finish and eventually shipping and infusing the cell product into the patient’s body.
Manufacturing our product candidates involves harvesting blood cells from a donor, isolating the gamma delta T or NK cells, activating and expanding the gamma delta T or NK cells, introducing a mRNA to be expressed on the gamma delta T cells, fill and finish, and eventually shipping and infusing the cell product into the patient’s body.
To the extent we encounter any such difficulties, our ability to conduct additional clinical trials or to scale for commercialization will be hindered or prevented, which would have an adverse effect on our business. Currently, we are in the midst of identifying potential collaboration partners to develop methods for the scaling up manufacturing of our product candidates.
To the extent we encounter any such difficulties, our ability to conduct additional clinical trials or to scale for commercialization will be hindered or prevented, which would have an adverse effect on our business. Currently, we are amid identifying potential collaboration partners to develop methods for the scaling up manufacturing of our product candidates.
Our business is highly reliant on the success of our product candidates, in particular CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC, and we may fail to develop CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC successfully or to obtain regulatory approval for them.
Our business is highly reliant on the success of our product candidates, in particular CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC, and CTM-NK, and we may fail to develop CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NKsuccessfully or to obtain regulatory approval for them.
Our principal shareholders, officers and directors beneficially own approximately 70.80% of our ordinary shares. This significant concentration of share ownership may adversely affect the trading price for our ordinary shares because investors often perceive disadvantages in owning shares in companies with controlling shareholders.
Our principal shareholders, officers and directors beneficially own approximately 28.26% of our Ordinary Shares. This significant concentration of share ownership may adversely affect the trading price for our Ordinary Shares because investors often perceive disadvantages in owning shares in companies with controlling shareholders.
We are unable to predict the effect that sales may have on the prevailing market price of our ordinary shares. Our principal shareholders, officers and directors beneficially own approximately 70.80% of our outstanding ordinary shares.
We are unable to predict the effect that sales may have on the prevailing market price of our Ordinary Shares. Our principal shareholders, officers and directors beneficially own approximately 28.26% of our outstanding Ordinary Shares.
As of the date of this annual report, we have forty-three (43) full-time employees. We are required to continue expanding our managerial, operational, quality, manufacturing, finance, sales and other resources in order to manage our operations and clinical trials, continue our development activities and eventually commercialize our product candidates.
As of the date of this annual report, we have forty-two (42) full-time employees. We are required to continue expanding our managerial, operational, quality, manufacturing, finance, sales and other resources to manage our operations and clinical trials, continue our development activities and eventually commercialize our product candidates.
Our ability to continue as a going concern is dependent on being able to obtain sufficient additional funding to finance our operations. Since our incorporation in 2018, we have incurred losses. As of December 31, 2022, 2023 and 2024, we have accumulated losses of S$8.20 million, S$12.33 million and S$14.85 million, respectively.
Our ability to continue as a going concern is dependent on being able to obtain sufficient additional funding to finance our operations. Since our incorporation in 2018, we have incurred losses. As of December 31, 2024 and 2025, we have accumulated losses of S$14.85 million and S$18.83 million, respectively.
In January 2024, Fate Therapeutics has announced initiation of a phase I clinical trial for an iPSC-derived CAR T-cell product targeting human epidermal growth factor receptor 2 (HER2). As of the date of this annual report, Takeda-CiRA joint program is in its pre-clinical stage.
In January 2024, Fate Therapeutics has announced initiation of a phase I clinical trial for an iPSC-derived CAR T-cell product targeting human epidermal growth factor receptor 2 (HER2). As of the date of this annual report, Takeda-CiRA joint program is in its pre-clinical stage. Our existing competitors in the field of natural killer cell therapy include Artiva Biotherapeutics, Inc.
In first quarter 2024, Bristol Myers Squibb (NYSE: BMY) announced U.S. FDA approval for CD19-directed CAR T cell therapy as the first and only CAR T cell therapy for adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as Priority Review for Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL).
FDA approval for CD19-directed CAR T cell therapy as the first and only CAR T cell therapy for adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as Priority Review for Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL).
We do not intend to renew and even if we renew such insurance, any such claim that may be brought could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance, or that is in excess of the limits of the insurance coverage.
We do not currently carry a valid directors and officers’ insurance policy, any such claim that may be brought could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance, or that is in excess of the limits of the insurance coverage.
(Nasdaq:GILD), NantKwest, INC. (Nasdaq:NK), Novartis International AG (NYSE:NVS), Surface Oncology, Inc. (Nasdaq:SURF), Takeda Pharmaceutical Company Limited (NYSE:TAK) and numerous other biopharmaceutical companies. We are aware of the recent developments of our potential competitors for allogeneic CAR gamma delta T- cell therapy.
(Nasdaq:GILD), Novartis International AG (NYSE:NVS), and numerous other biopharmaceutical companies. We are aware of the recent developments of our potential competitors for allogeneic CAR gamma delta T- cell therapy.
As of December 31, 2022, 2023 and 2024, we had cash and bank balances of, S$1.58 million, S$9.00 million, and S$4.97 million respectively. Our research expenses were S$1.52 million, S$1.59 million and S$1.91 million, for the financial year ended December 31, 2022, 2023 and 2024, respectively.
As of December 31, 2024 and 2025, we had cash and bank balances of S$4.97 million, and S$2.10 million, respectively. Our research expenses were S$1.91 million and S$2.22 million for the financial year ended December 31, 2024 and 2025, respectively.
If we are unable to successfully develop and commercialize CTM-N2D for these additional clinical trial indications, our commercial opportunities will be limited. 7 Enrollment and retention of patients for clinical trials is costly and time-consuming and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
If we are unable to successfully develop and 7 Enrollment and retention of patients for clinical trials is costly and time-consuming and could be delayed, made more difficult or rendered impossible by multiple factors outside our control. Identifying and qualifying suitable patients to participate in our clinical trials is vital to our development of our product candidates.
(Nasdaq: ACET) announced the dosing of the first patient in the Phase 1 clinical trial evaluating their gamma delta 1 CAR T cell candidates ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma. Our existing competitors in the field of gamma delta T cell therapy are listed in Table 2 of the section entitled “Competition” in this annual report.
In December 2024, Adicet Bio, Inc. (Nasdaq: ACET) announced the dosing of the first patient in the Phase 1 clinical trial evaluating their gamma delta 1 CAR T cell candidates ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma.
We are aware of the recent development of our potential competitor for allogeneic gamma delta T- cell therapy.
Our existing competitors in the field of gamma delta T cell therapy are listed in Table 2 of the section entitled “Competition” in this annual report. We are aware of the recent development of our potential competitor for allogeneic gamma delta T- cell therapy.
On April 18, 2023, we consummated our Offering resulting in net proceeds of approximately S$10.31 million (U.S.$7.81 million) after deducting underwriting discounts, commissions and offering expenses. We intend to use the proceeds from our Offering to, among other uses, advance CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC through clinical development. Developing pharmaceutical products and conducting pre-clinical studies and clinical trials are expensive.
We intend to use the proceeds from our offerings to, among other uses, advance CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC through clinical development. Developing pharmaceutical products and conducting pre-clinical studies and clinical trials are expensive. In the future, we may require additional cash funding to continue to execute our strategic plan and fund operations from time to time.
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In the future, we may require additional cash funding to continue to execute our strategic plan and fund operations from time to time.
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On April 18, 2023, we consummated our initial public offering resulting in net proceeds of approximately S$10.31 million (U.S.$7.81 million) after deducting underwriting discounts, commissions and offering expenses. On August 18, 2025, we entered into an ATM sales agreement with R.F. Lafferty & Co., Inc, pursuant to which the Company may sell up to U.S.$4,304,945 of Ordinary Shares.
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Identifying and qualifying suitable patients to participate in our clinical trials is vital to our development of our product candidates.
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As of December 2025, ACE1831 was approved by Japan’s PMDA and China’s NMPA for the treatment of the IgG4-RD fibroinflammatory autoimmune disease, outside of its original oncology treatment, in a Phase Ib/IIa clinical trial. In first quarter 2024, Bristol Myers Squibb (NYSE: BMY) announced U.S.
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In October 2024, Immatics N.V. (NASDAQ: IMTX) provided a data update on IMA203 monotherapy in 28 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells). In December 2024, Adicet Bio, Inc.
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In September 2025, Juno Therapeutics, Inc, a subsidiary of Bristol Myers Squibb, initiated a Phase I clinical trial to treat refractory autoimmune diseases with allogeneic CD-19 CAR-T cell therapy (NCT07115745). In December 2025, Immatics N.V.
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We do not currently carry a valid Directors’ and Officers’ insurance policy which expired on April 19, 2024.
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(NASDAQ: IMTX) provided a data update on IMA203 monotherapy in 78 heavily pretreated patients with advanced and/or metastatic solid tumors expressing PRAME (42 melanoma, 11 ovarian carcinoma, 11 synovial sarcoma, and 5 other tumor types) from the ongoing Phase 1a dose escalation clinical trial (NCT03686124).
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Patients were treated and well tolerated across a range of 0.4 to 12.5x10 9 autologous TCR-T cells, at a median dose level of 1.6 x 10 9 TCR-T cells The trial is currently ongoing at a dose escalation level 7 (7.2 – 10x10 9 TCR-T cells) based on the manageable tolerability profile and is on track to determine the recommended Phase 2 dose (RP2D).
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As of July 2025, the development of ADI-270 for patients with metastatic/advanced clear renal cell carcinoma (ccRCC) has been discontinued and enrollment for the clinical trial has been closed. Instead, they will be focusing on ADI-212, armored PSMA CAR gamma delta 1 T cell, for the clinical treatment of metastatic castration-resistant prostate cancer in second quarter of 2025.
Added
(NASDAQ:ARTV), Glycostem Therapeutics B.V., Indapta Therapeutics, Celularity (NASDAQ:CELU), Gamida Cell, Ingenium Therapeutics, SMT Bio co Ltd, Alphageneron Pharmaceuticals & MultiImmune, Wugen, and NKGen Biotech that are involved in modified and unmodified NK cell therapy.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

82 edited+50 added−7 removed415 unchanged
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
National University Hospital Singapore has obtained approval from the Singapore National Healthcare Group Domain Specific Review Boards in February 2023.
National University Hospital Singapore has obtained approval from the Singapore National Healthcare Group Domain Specific Review Boards in February 2023.
Pursuant to the Clinical Study Agreement, Company has agreed to (i) provide funding and supply at no cost to National University Hospital Singapore such quantities of the CTM-N2D as may be required for the ANGELICA Trial, (ii) to provide all relevant clinical information, (iii) where applicable, to provide an instruction manual/guide, product labels, storage, handling and safety instructions and advice which are required for the safe and proper use of CTM-N2D and the proper planning and conduct of the trial.
Pursuant to the Clinical Study Agreement, Company has agreed to (i) provide funding and supply at no cost to National University Hospital Singapore such quantities of the CTM-N2D as may be required for the ANGELICA Trial, (ii) to provide all relevant clinical information, (iii) where applicable, to provide an instruction manual/guide, product labels, storage, handling and safety instructions and advice which are required for the safe and proper use of CTM-N2D and the proper planning and conduct of the trial.
Either party may terminate the Clinical Study Agreement at any time upon providing at least thirty (30) days’ prior written notice to the other party.
Either party may terminate the Clinical Study Agreement at any time upon providing at least thirty (30) days’ prior written notice to the other party.
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects, following the HSA’s acknowledgement on January 6, 2023 that we had submitted the relevant documents to meet the approval conditions of the CTA initially granted in July 2022 relating to the use of our CTM-N2D for the aforementioned trial by HSA, and no further action was required.
Under by-law 3(3) of the Johor Bahru By-Laws, any person who contravenes by-law 3(1) shall be guilty of an offence and shall, upon conviction, be liable to a fine of not exceeding RM2,000 or to imprisonment for a term of not exceeding 1 year or to both. 105 OSHA The Occupational Safety and Health (Amendment) Act 2022 (“OSH Amendment Act”) which came into force on June 1, 2024, introduces significant changes to the OSHA, including but not limited to: (i) extension of OSHA’s applicability to all places of work; (ii) new duties on principal, employer and self-employed persons; (iii) appointment of occupational safety and health coordinator for businesses employing 5 or more employees; (iv) employees’ right to ‘remove’ themselves from ‘imminent danger’ at the workplace; (v) enhanced penalties and punishments for recalcitrant employers, self-employed persons, principals, and manufacturers; (vi) expansion of categories of persons who are to be jointly and severally liable for offences by companies or other bodies of persons; and (vii) integration of requirements under the FMA (repealed) to allow for OSHA to become a comprehensive health and safety legislation.
Under by-law 3(3) of the Johor Bahru By-Laws, any person who contravenes by-law 3(1) shall be guilty of an offence and shall, upon conviction, be liable to a fine of not exceeding RM2,000 or to imprisonment for a term of not exceeding 1 year or to both. 108 OSHA The Occupational Safety and Health (Amendment) Act 2022 (“OSH Amendment Act”) which came into force on June 1, 2024, introduces significant changes to the OSHA, including but not limited to: (i) extension of OSHA’s applicability to all places of work; (ii) new duties on principal, employer and self-employed persons; (iii) appointment of occupational safety and health coordinator for businesses employing 5 or more employees; (iv) employees’ right to ‘remove’ themselves from ‘imminent danger’ at the workplace; (v) enhanced penalties and punishments for recalcitrant employers, self-employed persons, principals, and manufacturers; (vi) expansion of categories of persons who are to be jointly and severally liable for offences by companies or other bodies of persons; and (vii) integration of requirements under the FMA (repealed) to allow for OSHA to become a comprehensive health and safety legislation.
Any person who fails to comply with either of the above shall be guilty of an offence and shall be liable on conviction to a fine not exceeding S$10,000 or to imprisonment for a term not exceeding 12 months or to both. 102 The HBRA requires that every research institution must, in respect of any human biomedical research which is carried out under its supervision and control, among others: (a) supervise, review and proactively monitor the conduct of the research; (b) designate a principal person in charge to be responsible for ensuring that the research institution complies with the provisions of the HBRA; (c) formula and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the research; (d) establish a data and safety monitoring board if its institutional review board considers that it is necessary for the purposes of any particular research proposal; and (e) investigate any areas of concern and take such remedial measures as appropriate.
Any person who fails to comply with either of the above shall be guilty of an offence and shall be liable on conviction to a fine not exceeding S$10,000 or to imprisonment for a term not exceeding 12 months or to both. 105 The HBRA requires that every research institution must, in respect of any human biomedical research which is carried out under its supervision and control, among others: (a) supervise, review and proactively monitor the conduct of the research; (b) designate a principal person in charge to be responsible for ensuring that the research institution complies with the provisions of the HBRA; (c) formula and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the research; (d) establish a data and safety monitoring board if its institutional review board considers that it is necessary for the purposes of any particular research proposal; and (e) investigate any areas of concern and take such remedial measures as appropriate.
The general functions, objects and duties of the HSA as stated in the HSA Act, include in particular: (i) to regulate the manufacture, import, export, sale, supply, advertisement and use of health products, tobacco products, radioactive materials and irradiating apparatuses in accordance with the applicable written laws; (ii) to conduct technological assessments of health products for the purpose of determining their quality, safety, efficacy and suitability for consumption and use in Singapore and to advise the Singapore government thereon; (iii) to provide professional, investigative, analytical and other services in health sciences and chemical metrology (relating to human health) to the Singapore government and to any other person or body (whether in Singapore or elsewhere); and (iv) to conduct or engage any other person to conduct research in health sciences, and generally to promote the development of health sciences. 97 MA Pharmaceutical products (also known as chemical or biological drugs) were previously regulated under the MA and Poisons Act 1938 of Singapore.
The general functions, objects and duties of the HSA as stated in the HSA Act, include in particular: (i) to regulate the manufacture, import, export, sale, supply, advertisement and use of health products, tobacco products, radioactive materials and irradiating apparatuses in accordance with the applicable written laws; (ii) to conduct technological assessments of health products for the purpose of determining their quality, safety, efficacy and suitability for consumption and use in Singapore and to advise the Singapore government thereon; (iii) to provide professional, investigative, analytical and other services in health sciences and chemical metrology (relating to human health) to the Singapore government and to any other person or body (whether in Singapore or elsewhere); and (iv) to conduct or engage any other person to conduct research in health sciences, and generally to promote the development of health sciences. 100 MA Pharmaceutical products (also known as chemical or biological drugs) were previously regulated under the MA and Poisons Act 1938 of Singapore.
ATPL may terminate the Patent License in circumstances including a breach by us remaining unremedied by us after thirty (30) days’ notice, including failure to meet development and commercialization milestones, an encumbrance taking possession or a receiver being appointed of any of our property or assets, any voluntary arrangement between us and our creditors, and/or cessation of our business, liquidation or receivership. 88 The aforementioned addendum in relation to the Patent License was entered into in respect of, amongst others, the NKG2DL-targeting CAR-gamma delta T cell and iPSC-gdNKT cell technology, which granted us the right to sublicense our license rights to our affiliates subject to certain conditions, such as ATPL being informed of any such sublicense within thirty (30) days of the execution of the same and such sublicense being on a non-exclusive basis only.
ATPL may terminate the Patent License in circumstances including a breach by us remaining unremedied by us after thirty (30) days’ notice, including failure to meet development and commercialization milestones, an encumbrance taking possession or a receiver being appointed of any of our property or assets, any voluntary arrangement between us and our creditors, and/or cessation of our business, liquidation or receivership. 92 The aforementioned addendum in relation to the Patent License was entered into in respect of, amongst others, the NKG2DL-targeting CAR-gamma delta T cell and iPSC-gdNKT cell technology, which granted us the right to sublicense our license rights to our affiliates subject to certain conditions, such as ATPL being informed of any such sublicense within thirty (30) days of the execution of the same and such sublicense being on a non-exclusive basis only.
The liability on offences against OSHA may be extended to director, compliance officer, partner, manager, secretary or other similar officer of the company unless if such person proves that the offence was committed without his knowledge and without his consent and that he had taken all reasonable precautions and exercised due diligence to prevent the commission of the offence. 106 EQA Licensing requirements Pursuant to section 21 of the EQA, there are acceptable conditions (“Acceptable Conditions”) specified for the emissions, discharge or deposit of environmentally hazardous substances, pollutants or wastes or the emission of noise into any area, segment or element of the environment as may be specified by the Minister of Natural Resources and Environmental Sustainability, in consultation with the Environmental Quality Council.
The liability on offences against OSHA may be extended to director, compliance officer, partner, manager, secretary or other similar officer of the company unless if such person proves that the offence was committed without his knowledge and without his consent and that he had taken all reasonable precautions and exercised due diligence to prevent the commission of the offence. 109 EQA Licensing requirements Pursuant to section 21 of the EQA, there are acceptable conditions (“Acceptable Conditions”) specified for the emissions, discharge or deposit of environmentally hazardous substances, pollutants or wastes or the emission of noise into any area, segment or element of the environment as may be specified by the Minister of Natural Resources and Environmental Sustainability, in consultation with the Environmental Quality Council.
License conditions will depend on the type of service provided and some services will require other licenses as a pre-requisite. 103 Section 3 of the HCSA defines “healthcare service” to mean any of the following services, whether or not provided for reward: (a ) assessment, diagnosis, treatment, prevention or alleviation of an ailment, a condition, disability, disease, disorder or an injury affecting any part of the human body or mind; ( b ) nursing or rehabilitative care of an individual suffering from an ailment, a condition, disability, disease, disorder or an injury mentioned in paragraph ( a ); ( c ) conduct of any clinical procedure to change, or that is intended to change, the appearance or anatomy of an individual; ( d ) assessment of the health of an individual; ( e ) any other service of a medical or healthcare nature that is prescribed; Licensable healthcare services mean any of the healthcare services listed in the First Schedule of the HCSA.
License conditions will depend on the type of service provided and some services will require other licenses as a pre-requisite. 106 Section 3 of the HCSA defines “healthcare service” to mean any of the following services, whether or not provided for reward: (a ) assessment, diagnosis, treatment, prevention or alleviation of an ailment, a condition, disability, disease, disorder or an injury affecting any part of the human body or mind; ( b ) nursing or rehabilitative care of an individual suffering from an ailment, a condition, disability, disease, disorder or an injury mentioned in paragraph ( a ); ( c ) conduct of any clinical procedure to change, or that is intended to change, the appearance or anatomy of an individual; ( d ) assessment of the health of an individual; ( e ) any other service of a medical or healthcare nature that is prescribed; Licensable healthcare services mean any of the healthcare services listed in the First Schedule of the HCSA.
Written notification to the Director General Generally, an owner of occupier of a premise must not, without giving prior written notification to the Director General under the Clean Air Regulations: (a) carry out any change in operation of his premises; (b) carry out any work on any premises that may result in a source of emission; (c) construct on any land, any building or premises designed or used for a purpose that may result in a new source of emission; (d) make, cause or permit to be made any change of, to, or in any plant, machine or equipment used or installed at the premises that causes a material change in the quantity or quality of emission from an existing source; or (e) carry out any changes or modifications to an existing air pollution control system. 107 The written notification must be submitted to the Director General not less than 30 days before the commencement of such work in such form as determined by the Director General.
Written notification to the Director General Generally, an owner of occupier of a premise must not, without giving prior written notification to the Director General under the Clean Air Regulations: (a) carry out any change in operation of his premises; (b) carry out any work on any premises that may result in a source of emission; (c) construct on any land, any building or premises designed or used for a purpose that may result in a new source of emission; (d) make, cause or permit to be made any change of, to, or in any plant, machine or equipment used or installed at the premises that causes a material change in the quantity or quality of emission from an existing source; or (e) carry out any changes or modifications to an existing air pollution control system. 110 The written notification must be submitted to the Director General not less than 30 days before the commencement of such work in such form as determined by the Director General.
We expect to expand our pipeline further in Phase II trials of CTM-N2D therapy for specific cancer indications. Our second product candidate, iPSC-gdNKT, utilizes iPSC as a starting material to generate gdNKT, which is a synthetic hybrid of a gamma delta T cell and a NK cell.
We expect to expand our pipeline further in Phase II trials of CTM-N2D therapy for specific cancer indications. 54 Our second product candidate, iPSC-gdNKT, utilizes iPSC as a starting material to generate gdNKT, which is a synthetic hybrid of a gamma delta T cell and a NK cell.
Reflecting this, Singapore set up a national agency in April 20, 2020 known as ACTRIS comprising, inter alia, all the national universities, hospitals, research institutions and funding agencies in Singapore. 96 Singapore It is intended that the Singapore Laboratory will be used, amongst others, to conduct research in Singapore.
Reflecting this, Singapore set up a national agency in April 20, 2020 known as ACTRIS comprising, inter alia, all the national universities, hospitals, research institutions and funding agencies in Singapore. Singapore It is intended that the Singapore Laboratory will be used, amongst others, to conduct research in Singapore.
By last quarter of 2024, the Company, through our subsidiary LongevityBank Pte Ltd, had completed acquisition of certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank, including (i) a private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia, held under IPSC Depository which is the direct subsidiary of LongevityBank Pte Ltd, (ii) cryopreservation equipment with more than 12,000 cord blood units (“CBUs”) and (iii) two freehold real estate properties measuring a total of 189 square metres in area in which the cord blood stem cell banking facility is situated.
In last quarter of 2024, the Company, through our subsidiary LongevityBank Pte Ltd, had completed acquisition of certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank, including (i) a private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia, held under IPSC Depository which is the direct subsidiary of LongevityBank Pte Ltd, (ii) cryopreservation equipment with more than 12,000 CB units and (iii) two freehold real estate properties measuring a total of 189 square metres in area in which the cord blood stem cell banking facility is situated.
It has come into effect on January 1, 2021 and provides that CGTPs fit within the meaning of medicinal products under the CDCR. In accordance to the CDCR, CGTPs would be classified as biological products, as defined above. As such, the Guidelines on CGTPs should be read in conjunction with CDCR.
It has come into effect on January 1, 2021 and provides that CGTPs fit within the meaning of products under the CDCR. In accordance to the CDCR, CGTPs would be classified as biological products, as defined above. As such, the Guidelines on CGTPs should be read in conjunction with CDCR.
Regulation 2 of the CTGTP Regulations states that CTGTPs are risk-stratified into two classes: (i) Class 1 CTGTPs are deemed lower risk and satisfy all of the following criteria: (a) minimally manipulated; (b) intended for homologous use (performing same function and administered at the same anatomical site or histological environment in the recipient as in the donor); and (c) not combined or used in conjunction with therapeutic products or medical devices as defined in the First Schedule to the HPA. 98 Examples of Class 1 CTGTPs include bone grafts, amniotic membrane, and skin.
Regulation 2 of the CTGTP Regulations states that CTGTPs are risk-stratified into two classes: (i) Class 1 CTGTPs are deemed lower risk and satisfy all of the following criteria: (a) minimally manipulated; (b) intended for homologous use (performing same function and administered at the same anatomical site or histological environment in the recipient as in the donor); and (c) not combined or used in conjunction with therapeutic products or medical devices as defined in the First Schedule to the HPA. 101 Examples of Class 1 CTGTPs include bone grafts, amniotic membrane, and skin.
Advertisements of CTGTPs refer to any information that can promote the sale or use of the CTGTP, and can be in any forms or media including but not limited to publication in a newspaper, magazine, journal or other periodical, display of posters or notices, circulars, brochures, pamphlets, books, letters addressed to individuals or organizational bodies, and/or any other activity intended to introduce, publicize or raise the profile or public awareness or visibility of any CTGTP for the purpose of promoting the sale or use of it. 99 Advertisements of CTGTPs must be aligned with the intended uses per its registration or notification made to HSA.
Advertisements of CTGTPs refer to any information that can promote the sale or use of the CTGTP, and can be in any forms or media including but not limited to publication in a newspaper, magazine, journal or other periodical, display of posters or notices, circulars, brochures, pamphlets, books, letters addressed to individuals or organizational bodies, and/or any other activity intended to introduce, publicize or raise the profile or public awareness or visibility of any CTGTP for the purpose of promoting the sale or use of it. 102 Advertisements of CTGTPs must be aligned with the intended uses per its registration or notification made to HSA.
Except as provided in the Know-How License, Puricell shall not adapt, translate, alter, copy reproduce, deal in, reverse engineer, decompile, disassemble, or create any derivative works based in whole or part on the licensed know-how. 89 Puricell is required to indemnify ATPL and its affiliates, officers, employees, and scientists against any loss, damages, costs, expenses or other claim for compensation which arises out or in connection with the Know-How License or in any way related to the licensed know-how, except to the extent caused by ATPL’s negligence or willful misconduct.
Except as provided in the Know-How License, Puricell shall not adapt, translate, alter, copy reproduce, deal in, reverse engineer, decompile, disassemble, or create any derivative works based in whole or part on the licensed know-how. 93 Puricell is required to indemnify ATPL and its affiliates, officers, employees, and scientists against any loss, damages, costs, expenses or other claim for compensation which arises out or in connection with the Know-How License or in any way related to the licensed know-how, except to the extent caused by ATPL’s negligence or willful misconduct.
The Guidelines on CGTPs addresses the development, manufacturing and quality control as well as non-clinical and clinical development of CGTPs which include somatic cell therapy, tissue engineering and gene therapy products. These guidelines are intended for products entering the registration process at the NPCB.
The Guidelines on CGTPs addresses the development, manufacturing and quality control as well as non-clinical and clinical development of CGTPs which include cell therapy, tissue engineering and gene therapy products. These guidelines are intended for products entering the registration process at the NPCB.
Additionally, the manufacturer’s license may be revoked by the Director of Pharmaceutical Services (as defined in the CDCR), according to regulation 17(1) of the CDCR if the manufacturer does not comply with GMP standards and requirements.
Additionally, the manufacturer’s license may be revoked by the Director of Pharmaceutical Services (as defined in the CDCR), according to regulation 17 of the CDCR if the manufacturer does not comply with GMP standards and requirements.
If we are not able to compete effectively against our existing and potential competitors, our business, financial condition, results of operations and growth prospects may be materially and adversely affected. 93 Prospects, Business Strategies and Future Plans Industry Overview and Prospects Immunotherapy is gaining recognition and acceptance as an alternative therapy to treatment of cancer, in particular, in cancer patients who do not respond well to conventional cancer treatment such as surgery, chemotherapy or radiation.
If we are not able to compete effectively against our existing and potential competitors, our business, financial condition, results of operations and growth prospects may be materially and adversely affected. 97 Prospects, Business Strategies and Future Plans Industry Overview and Prospects Immunotherapy is gaining recognition and acceptance as an alternative therapy to treatment of cancer, in particular, in cancer patients who do not respond well to conventional cancer treatment such as surgery, chemotherapy or radiation.
Additional requirements such as prior approval from the HSA must be complied with if a CRM comprises controlled drugs and psychotropic substances, poisons and radiopharmaceuticals. 101 Clinical Trials Regulations Following the HPA Order 2021 coming into effect, which specified and defined CTGTPs as a distinct category of products under the HPA, all Class 2 CTGTPs used in research are subject to the Clinical Trials Regulations with effect from March 1, 2021.
Additional requirements such as prior approval from the HSA must be complied with if a CRM comprises controlled drugs and psychotropic substances, poisons and radiopharmaceuticals. 104 Clinical Trials Regulations Following the HPA Order 2021 coming into effect, which specified and defined CTGTPs as a distinct category of products under the HPA, all Class 2 CTGTPs used in research are subject to the Clinical Trials Regulations with effect from March 1, 2021.
Based on publicly disclosed information, in May 2023 Acepodia Biotech, Inc. announced first patient dosed in their phase 1 clinical trial of an anti-CD20 armed allogeneic gamma delta T-cell therapy to treat patients with Non-Hodgkin’s Lymphoma, as well as FDA Clearance of Investigational New Drug (IND) Application for a First-in-Class Allogeneic Anti-EGFR Cell Therapy.
Based on publicly disclosed information, in May 2023 Acepodia Biotech, Inc. announced first patient dosed in their phase 1 clinical trial of an anti-CD20 armed allogeneic gamma delta T-cell therapy (ACE1831) to treat patients with Non-Hodgkin’s Lymphoma, as well as FDA Clearance of Investigational New Drug (IND) Application for a First-in-Class Allogeneic Anti-EGFR Cell Therapy (ACE2016).
Our subsidiary, IPSC Depository, being the holder of the private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia under the PHFSA, is required, and has registered, to be a data controller under the PDPA Malaysia. 111 Permits, licenses and approvals As of the date of this annual report, we have the necessary licenses, permits and approvals in Malaysia required for the operations of CytoMed Malaysia and IPSC Depository.
Our subsidiary, IPSC Depository, being the holder of the private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia under the PHFSA, is required, and has registered, to be a data controller under the PDPA Malaysia. 114 Permits, licenses and approvals As of the date of this annual report, we have the necessary licenses, permits and approvals in Malaysia required for the operations of CytoMed Malaysia and IPSC Depository.
Prospective investors should consult their own advisers regarding the implication of the laws and regulations on us. 104 Operation of business The following laws and regulations are generally applicable to the operation of CytoMed Malaysia’s business in Malaysia: ICA Section 3(1) of the ICA provides that, no person shall engage in any manufacturing activity unless he is issued a license in respect of such manufacturing activity.
Prospective investors should consult their own advisers regarding the implication of the laws and regulations on us. 107 Operation of business The following laws and regulations are generally applicable to the operation of CytoMed Malaysia’s business in Malaysia: ICA Section 3(1) of the ICA provides that, no person shall engage in any manufacturing activity unless he is issued a license in respect of such manufacturing activity.
Depending on the requirements of the specific clinical trials, research and/or treatments and industry standards from time to time, we will also be required to adhere to international guidelines such as the Guidelines for Good Clinical Practice of the International Conference on Harmonization. 100 PHMCA ECEG 2016 and HME 2016 The ECEG 2016 provides guidance for inculcating good medical practice in Singapore based on the fundamental tenets of medical ethics.
Depending on the requirements of the specific clinical trials, research and/or treatments and industry standards from time to time, we will also be required to adhere to international guidelines such as the Guidelines for Good Clinical Practice of the International Conference on Harmonization. 103 PHMCA ECEG 2016 and HME 2016 The ECEG 2016 provides guidance for inculcating good medical practice in Singapore based on the fundamental tenets of medical ethics.
In January 2024, Fate Therapeutics has announced initiation of a phase I clinical trial for an iPSC-derived CAR T-cell product targeting human epidermal growth factor receptor 2 (HER2). As of the date of this annual report, Takeda-CiRA joint program is in its pre-clinical stage. 92 Table 2.
In January 2024, Fate Therapeutics has announced initiation of a phase I clinical trial for an iPSC-derived CAR T-cell product targeting human epidermal growth factor receptor 2 (HER2). As of the date of this annual report, Takeda-CiRA joint program is in its pre-clinical stage. 96 Table 2.
According to the CDCR, all registered products and notified cosmetics are to be manufactured within GMP compliant premises. ‘Manufacturing’ is defined as (a) the making of assembling of the product, (b) the enclosing or packing of the product in any container in a form suitable for administration or application, and the labelling of the container, and (c) the carrying out of any process in the course of any of the foregoing activities.
According to the CDCR, all registered products and notified cosmetics are to be manufactured within GMP compliant premises. ‘Manufacture’ is defined as (a) the making of assembling of the product, (b) the enclosing or packing of the product in any container in a form suitable for administration or application, and the labelling of the container, and (c) the carrying out of any process in the course of any of the foregoing activities.
Such platform technologies and the resulting product candidates exploit the multiple antigen recognition systems of NK cells and gamma delta T cells in the human body to recognize and treat a broad range of cancers. Built on the proprietary platform technologies that we licensed, we are developing three cellular immunotherapy product candidates: CTM-N2D, iPSC-gdNKT and CTM-GDT.
Such platform technologies and the resulting product candidates exploit the multiple antigen recognition systems of NK cells and gamma delta T cells in the human body to recognize and treat a broad range of cancers. Built on the proprietary platform technologies that we licensed, we are developing four cellular immunotherapy product candidates: CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-NK.
We have already recruited a competent team of scientists and technicians and have provided them with the necessary training to manufacture the investigational product for clinical trial. In November 2024, the first patient has been dosed in our ANGELICA Trial for the clinical study of CTM-N2D. We anticipate recruiting more patients in 2025.
We have already recruited a competent team of scientists and technicians and have provided them with the necessary training to manufacture the investigational product for clinical trial. In November 2024, the first patient has been dosed in our ANGELICA Trial for the clinical study of CTM-N2D. We anticipate recruiting more patients in 2026.
Under CDCR, a product means a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose or a drug to be used as an ingredient of a preparation for a medicinal purpose. 108 The Guidelines on CGTPs for CGTPs were issued under regulation 29 of the CDCR.
Under CDCR, a product means a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose or a drug to be used as an ingredient of a preparation for a medicinal purpose. 111 The Guidelines on CGTPs for CGTPs were issued under regulation 29 of the CDCR.
The total gross floor area of the factory is approximately 8,600 square feet, of which 1,500 square feet is dedicated to our cGMP Facility comprising cleanrooms which support cGMP manufacturing of cell therapy products, a quality control laboratory, a cryostorage room, a control room and a material storage room. 85 Figure 24.
The total gross floor area of the factory is approximately 8,600 square feet, of which 1,500 square feet is dedicated to our cGMP Facility comprising cleanrooms which support cGMP manufacturing of cell therapy products, a quality control laboratory, a cryostorage room, a control room and a material storage room. 88 Figure 24.
Our trademark registration in the People’s Republic of China has been registered on October 28, 2024 and will be due for renewal on October 28, 2034. Domain Names As of the date of this annual report, the Company owns the domain name “Cytomed.sg”, which was registered in 2018 and is due for renewal in 2026.
Our trademark registration in the People’s Republic of China has been registered on October 28, 2024 and will be due for renewal on October 28, 2034. Domain Names As of the date of this annual report, the Company owns the domain name “Cytomed.sg”, which was registered in 2018 and is due for renewal in 2028.
Any person who contravenes any of the above provisions shall be guilty of an offence and shall be liable to fines ranging from RM10,000 to RM10,000,000 (depending on the provisions contravened) or to imprisonment for a period not exceeding 5 years or to both and to a further fine not exceeding RM1,000 a day (RM500 a day for noise pollution) for every day that the offence is continued after a notice by the Director General requiring him to cease the act specified therein has been served upon the offender.
Any person who contravenes any of the above provisions shall be guilty of an offence and shall be liable to fines ranging from RM10,000 to RM10,000,000 (depending on the provisions contravened) or to imprisonment for a period not exceeding 5 years or to both and to a further fine not exceeding RM1,000 a day for every day that the offence is continued after a notice by the Director General requiring him to cease the act specified therein has been served upon the offender.
The hybrid cells express receptors of both cells which potentially allow the gdNKT cells to recognize and treat a broad range of cancers. This product has been undergoing pre-clinical process development since the fourth quarter of 2022 and is targeting to commence pre-clinical studies after the fourth quarter of 2025.
The hybrid cells express receptors of both cells which potentially allow the gdNKT cells to recognize and treat a broad range of cancers. This product has been undergoing pre-clinical process development since the fourth quarter of 2022 and is targeting to commence pre-clinical studies after the fourth quarter of 2026.
These certificates are required by the overseas regulatory agencies for the purpose of product registration in the respective countries. 109 Any person who contravenes any of the provisions of the CDCR or any condition of any license issued under the CDCR or any condition subject to which a product is registered under the CDCR commits an offence.
These certificates are required by the overseas regulatory agencies for the purpose of product registration in the respective countries. 112 Any person who contravenes any of the provisions of the CDCR or any condition of any license issued under the CDCR or any condition subject to which a product is registered under the CDCR commits an offence.
The term “foreign workers” will also include expatriates, as defined under the EA. 110 ESSA Monthly contributions will also have to be made to SOCSO both by the employer and employees irrespective of the amount of wages as per the rates set out in the Third Schedule of the ESSA.
The term “foreign workers” will also include expatriates, as defined under the EA. 113 ESSA Monthly contributions will also have to be made to SOCSO both by the employer and employees irrespective of the amount of wages as per the rates set out in the Third Schedule of the ESSA.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by ensuring constant physical security for our premises, physical and electronic security of our information technology systems and maintaining back-ups of our information. 91 Trademarks We also seek to protect our brand through trademark rights.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by ensuring constant physical security for our premises, physical and electronic security of our information technology systems and maintaining back-ups of our information. 95 Trademarks We also seek to protect our brand through trademark rights.
Other than CytoMed Malaysia, our subsidiaries have minimal operations. We also have an operating cGMP Facility in Johor, Malaysia (which is near Singapore) which has been built in accordance with the international PIC/S GMP standards to manufacture cell therapy products to support clinical trials.
Other than CytoMed Malaysia and IPSC Depository, our subsidiaries have minimal operations. We also have an operating cGMP Facility in Johor, Malaysia (which is near Singapore) which has been built in accordance with the international PIC/S GMP standards to manufacture cell therapy products to support clinical trials.
We intend to capitalize on our close connections with A*STAR to tap into the latest developments and advances in cell-based therapeutics in the field of cancer treatment. 94 Business Strategies and Future Plans CytoMed is a clinical stage biopharmaceutical company and aims to establish itself as one of the leading biopharmaceutical companies in Asia engaged in the immunotherapy and degenerative diseases R&D, with the goal of providing affordable cell-based cancer immunotherapy for unmet needs and MSC for treatment of degenerative diseases.
We intend to capitalize on our close connections with A*STAR to tap into the latest developments and advances in cell-based therapeutics in the field of cancer treatment. 98 Business Strategies and Future Plans CytoMed is a clinical stage biopharmaceutical company and aims to establish itself as one of the leading biopharmaceutical companies in Asia engaged in cancer immunotherapy and degenerative diseases R&D, with the goal of providing affordable allogeneic immune cell-based cancer therapy for unmet needs and MSC for treatment of degenerative diseases.
On December 30, 2024, the Company entered into a BRCA with SunAct Cancer Institute Private Limited to jointly establish and conduct clinical trials for the GMP grade CTM-GDT. The collaboration encompasses territories including South Asia (Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, Sri Lanka, and Afghanistan) and the Emirate of Dubai.
On December 30, 2024, the Company entered into a BRCA with SUNACT to jointly establish and conduct clinical trials for the GMP grade CTM-GDT. The collaboration encompasses territories including South Asia (Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, Sri Lanka, and Afghanistan) and the Emirate of Dubai.
Through a US agent, we have submitted a drug master file to the US FDA and intend to pursue an investigational new drug application in the near future. In Malaysia, CTM-GDT is classified as a CGTP by NPRA. As we intend to manufacture the investigational product locally, a CTX application to NPRA is required before commencing clinical trials.
Through a U.S. agent, we have submitted a drug master file to the U.S. FDA and intend to pursue an investigational new drug (IND) application in the near future. In Malaysia, CTM-GDT is classified as a CGTP by NPRA. As we intend to manufacture the investigational product locally, a CTX application to NPRA is required before commencing clinical trials.
Pursuant to the Clinical Study Agreement, the National University Hospital Singapore will conduct the ANGELICA Trial using our lead product candidate CTM-N2D, with Dr. Anand D Jeyasekharan, Consultant, Department of Hematology-Oncology of National University Hospital Singapore, being the principal investigator of the trial. Unless terminated earlier, the Clinical Study Agreement shall continue until completion of the trial.
Pursuant to the Clinical Study Agreement, the National University Hospital Singapore is conducting the ANGELICA Trial using our lead product candidate CTM-N2D, with Dr. Anand D Jeyasekharan, Consultant, Department of Hematology-Oncology of National University Hospital Singapore, being the principal investigator of the trial. Unless terminated earlier, the Clinical Study Agreement shall continue until completion of the trial.
Royalties which are calculated based on tiered low single-digit percentage of net sales, and an annual minimum royalty, payable until the end of the term of the Patent License. To date, we have paid APTL an aggregate of S$128,800, including an upfront license fee, annual minimum royalty and the milestone payment.
Royalties which are calculated based on tiered low single-digit percentage of net sales, and an annual minimum royalty, payable until the end of the term of the Patent License. To date, we have paid APTL an aggregate of S$139,700, including an upfront license fee, annual minimum royalty and the milestone payment.
Other than CytoMed Malaysia and IPSC Depository, our subsidiaries have minimal operations. D. Property, plants and equipment For a description of our property, plants and equipment, see Item 4.B. Business Overview. ITEM 4.A. UNRESOLVED STAFF COMMENTS None.
Other than CytoMed Malaysia and IPSC Depository, our subsidiaries have minimal operations. D. Property, plants and equipment For a description of our property, plants and equipment, see “Item 4.B. Business Overview” . ITEM 4.A. UNRESOLVED STAFF COMMENTS None.
Under the BRCA, the Company will be responsible for manufacturing and supplying the CTM-GDT, providing scientific expertise, laboratory staff support, and assistance with clinical data management and protocol development. SunAct Cancer Institute Private Limited will lead the clinical trial operations, including obtaining necessary regulatory approvals, recruiting patients, and providing clinical trial guidance.
Under the BRCA, the Company will be responsible for manufacturing and supplying the CTM-GDT, providing scientific expertise, laboratory staff support, and assistance with clinical data management and protocol development. SUNACT will lead the clinical trial operations, including obtaining necessary regulatory approvals, recruiting patients, and providing clinical trial guidance.
In October 2024, we received co-funding support for our ANGELICA Trial from the MOH Singapore through the National Medical Research Council (“NMRC”) Office, and MOH Holdings Pte Ltd under the NMRC Clinical Trial Grant Industry Collaborative Trials scheme (MOH-001646).
In October 2024, we received co-funding support for our ANGELICA Trial from the MOH Singapore through the National Medical Research Council (“NMRC”) Office, and MOH Holdings Pte Ltd under the NMRC Clinical Trial Grant Industry Collaborative Trials scheme (MOH-001646). Patient recruitment for ANGELICA Trial started in November 2024.
In October 2024, we received co-funding support for our ANGELICA trial from the MOH Singapore through the National Medical Research Council (“NMRC”) Office, and MOH Holdings Pte Ltd under the NMRC Clinical Trial Grant Industry Collaborative Trials scheme (MOH-001646).
In October 2024, we received co-funding support for our ANGELICA trial from the MOH Singapore through the National Medical Research Council (“NMRC”) Office, and MOH Holdings Pte Ltd under the NMRC Clinical Trial Grant Industry Collaborative Trials scheme (MOH-001646). Patient recruitment for ANGELICA Trial started in November 2024.
Our cGMP Facility. 86 Cord Blood Bank Location in Malaysia By last quarter of 2024, the Company, through our subsidiary LongevityBank Pte Ltd, had completed acquisition of certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank, including (i) a private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia, (ii) cryopreservation equipment with more than 12,000 cord blood units (“CBUs”) and (iii) two freehold real estate properties measuring a total of189 square metres in area in which the cord blood stem cell banking facility is situated.
Our cGMP Facility. 89 Cord Blood Bank Location in Malaysia In last quarter of 2024, the Company, through our subsidiary LongevityBank Pte Ltd, had completed acquisition of certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank, including (i) a private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia, (ii) cryopreservation equipment with more than 12,000 CB units and (iii) two freehold real estate properties measuring a total of 189 square meters in area in which the cord blood stem cell banking facility is situated.
We are using the premises as our administration office and laboratory to conduct R&D and support research in our cGMP Facility in Malaysia, having fully fitted it with the necessary facilities and equipment to conduct research on GMP-grade iPSC and other cell type manufacture as well as cryopreservation of our CTM-N2D product for overseas export. 82 83 84 Figure 23.
We are using the premises as our administration office and laboratory to conduct R&D and support research in our cGMP Facility in Malaysia, having fully fitted it with the necessary facilities and equipment to conduct research on GMP-grade iPSC and other cell type manufacture as well as cryopreservation of our CTM-N2D product for overseas export. 85 86 87 Figure 23.
Our iPSC-gdNKT platform is in the pre-clinical development stage as of the date of this annual report. REGULATION Cell-based therapies are still considered novel and a new medical science in South-east Asia. The CTGTP Regulations in Singapore became effective on March 1, 2021. Malaysia’s CGTP regulations became effective on January 1, 2021.
Our iPSC-gdNKT and CTM-NK platforms are in the pre-clinical development stage as of the date of this annual report. 99 REGULATION Cell-based therapies are still considered novel and a new medical science in South-east Asia. The CTGTP Regulations in Singapore became effective on March 1, 2021. Malaysia’s CGTP regulations became effective on January 1, 2021.
The premises consist of an office, a cleanroom, a quality control laboratory and have the capacity to harvest, process, cryopreserve and bank cells including cord blood stem cells in general, and to carry out research and development on cell-based therapy. Figure 25. Our Cord Blood Storage and Processing Facility.
The premises consist of an office, a cleanroom, a quality control laboratory and have the capacity to harvest, process, cryopreserve and bank cells including cord blood stem cells in general, and to carry out research and development on cell-based therapy.
All the study results shall be jointly owned by both parties. Discoveries or inventions that relate to any enhancements or modifications to the CTM-N2D arising from the conduct of the ANGELICA Trial, whether conceived or reduced to practice either solely by or jointly with National University Hospital Singapore, will be the joint property of National University Hospital Singapore and Company.
Discoveries or inventions that relate to any enhancements or modifications to the CTM-N2D arising from the conduct of the ANGELICA Trial, whether conceived or reduced to practice either solely by or jointly with National University Hospital Singapore, will be the joint property of National University Hospital Singapore and Company.
Our known biopharmaceutical competitors working on allogeneic CAR-T therapies currently include Allogene Therapeutics, Inc. (Nasdaq:ALLO), Astellas Pharma Inc. (TSE:4503.T), Bristol-Myers Squibb (NYSE:BMY), Celyad Oncology SA (Nasdaq:CYAD), Fate Therapeutics, Inc. (Nasdaq:FATE), Gilead Sciences, Inc. (Nasdaq:GILD), NantKwest, INC. (Nasdaq:NK), Novartis International AG (NYSE:NVS), Surface Oncology, Inc. (Nasdaq:SURF), Takeda Pharmaceutical Company Limited (NYSE:TAK) and numerous other biopharmaceutical companies.
Our known biopharmaceutical competitors working on allogeneic CAR-T therapies currently include Allogene Therapeutics, Inc. (Nasdaq:ALLO), Astellas Pharma Inc. (TSE:4503.T), Bristol-Myers Squibb (NYSE:BMY), Celyad Oncology SA (Nasdaq:CYAD), Fate Therapeutics, Inc. (Nasdaq:FATE), Gilead Sciences, Inc. (Nasdaq:GILD), Novartis International AG (NYSE:NVS), and numerous other biopharmaceutical companies.
The project combines the Company’s product expertise and manufacturing capabilities with SunAct Cancer Institute Private Limited’s clinical research infrastructure to advance the development and commercialization of the CTM-GDT in the specified territories. On March 20, 2025, an investigator-initiated clinical trial has been registered with the Clinical Trials Registry – India to evaluate CTM-GDT in solid tumors and lymphomas. Dr. Prof.
The project combines the Company’s product expertise and manufacturing capabilities with SUNACT’s clinical research infrastructure to advance the development and commercialization of the CTM-GDT in the specified territories. On March 20, 2025, an investigator-initiated clinical trial (IIT) has been registered with the Clinical Trials Registry - India to evaluate CTM-GDT in solid tumors and lymphomas.
As of the date of this annual report, we are a holding company incorporated in Singapore which oversees our operations in Malaysia. We conduct our business activities primarily through our direct wholly-owned subsidiary in Malaysia, CytoMed Malaysia, but expect to conduct more research and clinical trial activities in Singapore through CytoMed moving forward.
As of the date of this annual report, we are a holding company incorporated in Singapore which oversees our operations in Malaysia. We conduct our business activities primarily through our subsidiaries in Malaysia, CytoMed Malaysia and IPSC Depository. We expect to conduct more research and clinical trial activities in Singapore through CytoMed moving forward.
We will rely on these licenses in developing products which we plan to seek and to obtain regulatory approval for and, upon receiving approval, plan to market and sell them worldwide. 87 Patent License In June 2018, we entered into an exclusive, worldwide, non-sublicensable, non-transferable and revocable-for-cause license with ATPL under two pending patent applications filed under the Patent Cooperation Treaty (PCT) related to NKG2DL-targeting CAR-gamma delta T cell and iPSC-gdNKT cell technology, and any granted patent(s) and application(s) claiming common priority with and from such applications in the field of immunotherapy, including stem cell therapy, which was subsequently amended by an addendum entered into in December 2020, a second addendum entered into in September 2021, and a third addendum entered into in October 2022 (“ Patent License ”).
Patent License In June 2018, we entered into an exclusive, worldwide, non-sublicensable, non-transferable and revocable-for-cause license with ATPL under two pending patent applications filed under the Patent Cooperation Treaty (PCT) related to NKG2DL-targeting CAR-gamma delta T cell and iPSC-gdNKT cell technology, and any granted patent(s) and application(s) claiming common priority with and from such applications in the field of immunotherapy, including stem cell therapy, which was subsequently amended by an addendum entered into in December 2020, a second addendum entered into in September 2021, and a third addendum entered into in October 2022 (“ Patent License ”).
The Company is required to indemnify ATPL and its affiliates, officers, employees, and scientists against any loss, damages, costs, expenses or other claim for compensation which arises out or in connection with the K562 Cell License for NK cell expansion or in any way related to the licensed products or modified human K562 cells, except to the extent caused by ATPL’s negligence or willful misconduct. 90 Unless earlier terminated, the K562 Cell License for NK cell expansion has a five (5) year term extendable on request.
The Company is required to indemnify ATPL and its affiliates, officers, employees, and scientists against any loss, damages, costs, expenses or other claim for compensation which arises out or in connection with the K562 Cell License for NK cell expansion or in any way related to the licensed products or modified human K562 cells, except to the extent caused by ATPL’s negligence or willful misconduct.
We are currently researching the use of MSCs, which are multipotential adult stem cells found in the supportive framework of organs and are the building blocks for tissue renewal and repair.
Depending on the types of stem cells, different types of stem cells possess different capacity of differentiation. We are currently researching the use of MSCs, which are multipotential adult stem cells found in the supportive framework of organs and are the building blocks for tissue renewal and repair.
In order to investigate the use of CGTPs in a local clinical trial, an application that reports data from pre-clinical studies on the likely safety and efficacy of the investigational product must be filed by NPCB. An approval for a CTIL or a CTX is mandatory before an unregistered CGTP is administered to human trial subjects in Malaysia.
In order to investigate the use of CGTPs in a local clinical trial, an application that reports data from pre-clinical studies on the likely safety and efficacy of the investigational product must be filed at NPRA. An approval for a CTIL or a CTX is mandatory before product is imported or manufactured for the purpose of clinical trial in Malaysia.
In first quarter 2024, Bristol Myers Squibb (NYSE: BMY) announced U.S. FDA approval for CD19-directed CAR T cell therapy as the first and only CAR T cell therapy for adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as Priority Review for Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL).
FDA approval for CD19-directed CAR T cell therapy as the first and only CAR T cell therapy for adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as Priority Review for Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL).
We may also explore setting up a joint laboratory in the U.S. depending on the extent of our collaboration with suitable partners there.
We may also explore setting up a joint laboratory outside of Singapore and Malaysia depending on the extent of our collaboration with suitable partners there.
They are important in the human body as they are able to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat many diseases. Depending on the types of stem cells, different types of stem cells possess different capacity of differentiation.
CTM-MSC Stem cells are unspecialized cells with the capacity to regenerate and replicate as well as to develop into different types of specialized cells in the body. They are important in the human body as they are able to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat many diseases.
Vijay Patil, Professor Consultant at SunAct Cancer Institute Private Limited, serves as the principal investigator for the trial. Our fourth product candidate, CTM-MSC, has been developed with donor-sourced, allogeneic umbilical cord-derived mesenchymal stem cells (“UC-MSCs”) and exploits their potential as a potential treatment for tissue regeneration, inflammatory and regenerative diseases.
Our fourth product candidate, CTM-MSC, has been developed with donor-sourced, allogeneic umbilical cord-derived mesenchymal stem cells (“UC-MSCs”) and exploits their potential as a potential treatment for tissue regeneration, inflammatory and regenerative diseases.
Our third product candidate, CTM-GDT, consists of expanded allogeneic gamma delta T cells and exploits the potential of these cells to recognize and treat a broad range of cancers. We are collaborating with The University of Texas M.D. Anderson Cancer Center on preclinical studies evaluating CTM-GDT for lymphoma and breast cancer.
Our third product candidate, CTM-GDT, consists of expanded allogeneic gamma delta T cells and exploits the potential of these cells to recognize and treat a broad range of cancers. A preclinical study, conducted in collaboration with The University of Texas M.D.
The Company is entitled to terminate the K562 Cell License for NK cell expansion on provision of at least two (2) months’ written notice.
Unless earlier terminated, the K562 Cell License for NK cell expansion has a five (5) year term extendable on request. 94 The Company is entitled to terminate the K562 Cell License for NK cell expansion on provision of at least two (2) months’ written notice.
National University Hospital Singapore may terminate the Clinical Study Agreement immediately in the event National University Hospital Singapore and/or the principal investigator believes on reasonable grounds that continuing the said trial poses an unacceptable risk to the rights, interests, safety or well-being of human subjects, or if a serious adverse event occurs which necessitates the discontinuance of the ANGELICA Trial. 54 Please refer to the sections entitled “Business - Our Solutions and Product Candidates: CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC” and “Business - CTM-N2D Therapy - Development Status of CTM-N2D Therapy” in this annual report for further details on the application process and progress.
National University Hospital Singapore may terminate the Clinical Study Agreement immediately in the event National University Hospital Singapore and/or the principal investigator believes on reasonable grounds that continuing the said trial poses an unacceptable risk to the rights, interests, safety or well-being of human subjects, or if a serious adverse event occurs which necessitates the discontinuance of the ANGELICA Trial.
We are headquartered in Singapore with our production facilities in Malaysia for cost efficiency. We intend to focus on developing our two (2) “off-the-shelf, allogeneic” technology platforms centered on gamma delta T cells and iPSCs respectively for cell based cancer immunotherapy, and MSC for degenerative diseases. Please refer to the “Business” section for further details.
We are headquartered in Singapore with our production facilities in Malaysia for cost efficiency. We intend to focus on developing the following technology platforms centered on allogeneic immune cell-based cancer therapy and stem cell-based therapy for degenerative diseases: 1. CAR-gamma delta T cells (CAR-γδ T cells) 2.
(Nasdaq: ACET) announced the dosing of the first patient in the Phase 1 clinical trial evaluating their gamma delta 1 CAR T cell candidates ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma. Our existing competitors in the field of gamma delta T cell therapy are listed in Table 2 of the section entitled “Competition” in this annual report.
In December 2024, Adicet Bio, Inc. (Nasdaq: ACET) announced the dosing of the first patient in the Phase 1 clinical trial evaluating their gamma delta 1 CAR T cell candidates ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma.
To realize the potential of iPSC-derived gamma delta NKT cells in cancer treatment, we have been in the process of further evaluating iPSC-derived gamma delta NKT cells in pre-clinical studies since the fourth quarter of 2022, and is targeting to commence pre-clinical studies after 2024. 81 Property Administration Office and Research Laboratory in Singapore We own the leasehold interest of Singapore Laboratory situated at 1 Commonwealth Lane, #08-22, Singapore 149544 ( Figure 23 ), which has an area of approximately 111 square meters housed in an industrial building within walking distance to Biopolis, a strategic district in Singapore designated for technology R&D and where A*STAR is located.
Enriched NK cells (CD3-/CD56+) make up 18.9% of cell population in the CB after excluding CD56- immune cell types. 84 Property Administration Office and Research Laboratory in Singapore We own the leasehold interest of Singapore Laboratory situated at 1 Commonwealth Lane, #08-22, Singapore 149544 ( Figure 23 ), which has an area of approximately 111 square meters housed in an industrial building within walking distance to Biopolis, a strategic district in Singapore designated for technology R&D and where A*STAR is located.
We are aware of the recent development of our potential competitor for allogeneic gamma delta T- cell therapy.
Our existing competitors in the field of gamma delta T cell therapy are listed in Table 2 of the section entitled “Competition” in this annual report. We are aware of the recent development of our potential competitor for allogeneic gamma delta T- cell therapy.
Lower business and operating costs in South-east Asia The relatively lower business and operating costs in South-east Asia should position us well to achieve our vision of developing our donor blood cell-based and iPSC-based platform technologies into off-the-shelf cancer immunotherapies with the ultimate goal to offer lower cost cell therapies as a form of cancer treatment to patients. 95 We have invested in and completed construction of our own cGMP Facility which is fully equipped with state-of-the-art equipment, which we believe is capable of handling the manufacturing for Phase I and Phase II clinical trials for our clinically-ready CAR T therapy, which is trade-named “CTM-N2D”.
Lower business and operating costs in South-east Asia The relatively lower business and operating costs in South-east Asia should position us well to achieve our vision of developing our donor blood cell-based and iPSC-based platform technologies into off-the-shelf cancer immunotherapies with the ultimate goal to offer lower cost cell therapies as a form of cancer treatment to patients.
We are considering conducting research in regenerative medicine and in particular, stem cell application in an aging population in Asia. We believe we are well-placed with the necessary expertise, experience and resources to take advantage of such prospects. Close connections with scientific and medical community Our core technologies are licensed from A*STAR, Singapore’s lead public sector R&D agency.
We believe that the Company is well positioned, with the necessary expertise, experience and resources to capture these emerging opportunities. Close connections with scientific and medical community Our core technologies are licensed from A*STAR, Singapore’s lead public sector R&D agency.
Our aim is to be amongst the pioneers of cellular immunotherapy treatment for cancer to serve the emerging economies within South-east Asia. We aim to strategically position ourselves as a bridge between the cutting-edge of cellular therapy in the U.S. and our origin amongst emerging economies in South-east Asia, with our headquarter located in Singapore.
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. Headquartered in Singapore, we are strategically positioned to serve as a bridge between the advanced cellular therapy ecosystem in the U.S. and the rapidly growing healthcare markets in Asia.
To this end, we are also developing allogeneic gamma delta T cells into CTM-GDT therapy for cancer treatment ( Figure 6 ). We are working with The University of Texas M.D. Anderson Cancer Center on CTM-GDT against lymphoma and breast cancer in preclinical studies.
To this end, we are also developing allogeneic gamma delta T cells into CTM-GDT therapy for cancer treatment ( Figure 6 ). A preclinical study, conducted in collaboration with The University of Texas M.D. Anderson Cancer Center, has been published in a research article entitled “ Donor-Derived Vγ9Vδ2 T Cells for Acute Myeloid Leukemia: A Promising ‘Off-the-Shelf’ Immunotherapy Approach ”.
On December 30, 2024, the we entered into a BRCA with SunAct Cancer Institute Private Limited. An investigator-initiated clinical trial has been registered with the Clinical Trials Registry – India on March 20, 2025, to evaluate CTM-GDT in solid tumors and lymphomas. Dr. Prof.
An investigator-initiated clinical trial was subsequently registered with the Clinical Trials Registry - India on March 20, 2025, to evaluate CTM-GDT in solid tumors and lymphomas. The trial was led by Dr. Prof. Vijay Patil, Professor Consultant at SUNACT, who serves as the principal investigator.
Through a US agent, we have submitted a drug master file to US FDA and intend to pursue an investigational new drug application in the near future. In Malaysia, CTM-GDT is classified as a CGTP by NPRA. As we intend to manufacture the investigational product locally, a CTX application to NPRA is required before commencing clinical trials.
In Malaysia, CTM-GDT is classified as a CGTP by NPRA. As we intend to manufacture the investigational product locally, a CTX application to NPRA is required before commencing clinical trials. This application is currently underway for a target commencement of a FIH Phase I clinical trial with Universiti Malaya in the second half of 2026.
In accordance with the definition provided in the National Wages Consultative Act 2011, individuals under apprenticeship will not be entitled to the minimum wage.
Pursuant to the National Wages Consultative Council (Amendment) Act 2025, apprenticeship contracts shall be entitled to the minimum wage.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

47 edited+13 added−25 removed25 unchanged
Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Quantitative and Qualitative Disclosures about Market Risks We are exposed to market risks in the ordinary course of our business. These risks primarily include currency risk and interest rate risk.
Our ability to generate sufficient product revenue to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Quantitative and Qualitative Disclosures about Market Risks We are exposed to market risks in the ordinary course of our business. These risks primarily include currency risk and interest rate risk.
This was primarily attributable to the loss for the year of S$4.13 million, adjusted for non-cash charges of S$477,368 for depreciation and amortization, fair value loss on convertible loans and unrealized currency translation losses, S$223,845 in fair value changes on warrant liabilities, S$51,282 in interest expenses, S$285,719 in interest income, S$31,198 in share of results of associate and a S$104,918 net change in working capital.
This was primarily attributable to the loss for the year of S$4.13 million, adjusted for non-cash charges of S$477,368 for depreciation and amortization, fair value loss on convertible loans and unrealized currency translation losses, S$223,845 in fair value changes on warrant liabilities, S$51,282 in interest expenses, S$285,719 in interest income, S$31,198 in share of results of associate and a net change in working capital of S$104,918.
This was primarily attributable to the loss for the year of S$2.52 million, adjusted for non-cash charges of S$319,330 for depreciation and amortization and unrealized currency translation losses, S$138,292 in fair value changes on warrant liabilities, S$20,313 in interest expenses, S$317,670 in interest income, S$13,765 in share of results of associate and a S$60,406 net change in working capital.
This was primarily attributable to the loss for the year of S$2.52 million, adjusted for non-cash charges of S$319,330 for depreciation and amortization and unrealized currency translation losses, S$138,292 in fair value changes on warrant liabilities, S$20,313 in interest expenses, S$317,670 in interest income, S$13,765 in share of results of associate and a net change in working capital of S$60,406.
Net cash used in investing activities during the financial year ended December 31, 2023 was S$2.73 million, mainly due to the placement of fixed deposits of S$2.77 million and partially offset by interest received of S$98,366.
Investing Activities Net cash used in investing activities during the financial year ended December 31, 2023 was S$2.73 million, mainly due to the placement of fixed deposits of S$2.77 million and partially offset by interest received of S$98,366.
During the financial year ended December 31, 2023, net cash generated from financing activities was S$10.92 million mainly due to the net proceeds from issuance of ordinary shares of S$11.31 million, partially offset by the repayment of a third party loan of S$300,000, interest payment of S$46,713 and repayment of bank borrowings of S$32,984.
Financing Activities During the financial year ended December 31, 2023, net cash generated from financing activities was S$10.92 million mainly due to the net proceeds from issuance of ordinary shares of S$11.31 million, partially offset by the repayment of a third party loan of S$300,000, interest payment of S$46,713 and repayment of bank borrowings of S$32,984.
During the financial year ended December 31, 2024, net cash used in financing activities was S$64,892, comprising the repayment of lease liabilities of S$9,797, interest payment of S$20,313 and repayment of bank borrowings of S$34,782.
During the financial year ended December 31, 2024, net cash used in financing activities was S$64,892, comprising the repayment of bank borrowings of S$34,782, interest payment of S$20,313 and repayment of lease liabilities of S$9,797.
Our future capital requirements will depend on many factors, including: ● the scope, timing, progress, costs, and results of discovery, pre-clinical development, and clinical trials for our current and future product candidates; ● the number of clinical trials required for regulatory approval of our current and future product candidates; ● the costs, timing, and outcome of regulatory review of any of our current and future product candidates; ● the cost of manufacturing clinical and commercial supplies of our current and future product candidates; 117 ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval; ● the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing on their intellectual property rights; ● the cost of maintaining our own R&D and centralized cGMP Facility and future facility expansion plans; ● our ability to maintain existing, and establish new, strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● the expenses to attract, hire and retain, skilled personnel; ● the costs of operating as a public company; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invest in businesses, products and technologies.
Our future capital requirements will depend on many factors, including: ● the scope, timing, progress, costs, and results of discovery, pre-clinical development, and clinical trials for our current and future product candidates; ● the number of clinical trials required for regulatory approval of our current and future product candidates; ● the costs, timing, and outcome of regulatory review of any of our current and future product candidates; ● the cost of manufacturing clinical and commercial supplies of our current and future product candidates; 120 ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval; ● the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing on their intellectual property rights; ● the cost of maintaining our own R&D and centralized cGMP Facility and future facility expansion plans; ● our ability to maintain existing, and establish new, strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● the expenses to attract, hire and retain, skilled personnel; ● the costs of operating as a public company; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invest in businesses, products and technologies.
Liquidity and Capital Resources Overview Since our incorporation, we have not generated any revenue from commercial sales of product and have incurred losses and negative cash flows from our operations and expect these conditions to continue for the foreseeable future.
B. Liquidity and Capital Resources Overview Since our incorporation, we have not generated any revenue from approved commercial sales of product and have incurred losses and negative cash flows from our operations and expect these conditions to continue for the foreseeable future.
All of our product candidates are designed to be allogeneic, meaning they are produced using cells from a different person than the patient treated, as well as on an “off-the-shelf” basis, unlike existing autologous cell therapies. Built on our proprietary platform technologies, we are developing four product candidates: CTM-N2D, iPSC-gdNKT, CTM-GDT and CTM-MSC.
All of our product candidates are designed to be allogeneic, meaning they are produced using cells from a different person than the patient treated, as well as on an “off-the-shelf” basis, unlike existing autologous cell therapies. Built on our proprietary platform technologies, we are developing five product candidates: CTM-N2D, iPSC-gdNKT, CTM-GDT, CTM-MSC and CTM-NK.
(2) Includes interest payments. (3) Loan to a third party at 5.0% interest per annum to set up our presence in China. Other than as shown above, we did not have any significant capital and other commitments, long term obligations or guarantees as of December 31, 2024. 118 C.
(2) Includes interest payments. (3) Loan to a third party at 5.0% interest per annum to set up our presence in China. Other than as shown above, we did not have any significant capital and other commitments, long term obligations or guarantees as of December 31, 2025. 121 C.
All translations from Singapore dollars to U.S. dollars and from U.S. dollars to Singapore dollars in this annual report are made at a rate of S$1.3662 to U.S.$1.00, the exchange rate in effect as of December 31, 2024 as set forth in the H.10 statistical release of the U.S. Board of Governors of the Federal Reserve System.
All translations from Singapore dollars to U.S. dollars and from U.S. dollars to Singapore dollars in this annual report are made at a rate of S$1.2859 to U.S.$1.00, the exchange rate in effect as of December 31, 2025 as set forth in the H.10 statistical release of the U.S. Board of Governors of the Federal Reserve System.
Key Components of Our Results of Operations Revenue Since our incorporation, we have not generated any revenue and do not expect to generate any revenue from the commercial sale of products in the foreseeable future. As of the date of this annual report, we have no therapeutic products approved for sale commercially.
Key Components of Our Results of Operations Revenue Since our incorporation, we have not generated any direct revenue from approved cell therapies and do not expect to generate any such revenue from the commercial sale of such products in the foreseeable future. As of the date of this annual report, we have no therapeutic products approved for sale commercially.
Non-refundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
We expense research costs as incurred. Non-refundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Other (losses)/gains including fair value changes on financial instruments - net Other (losses)/gains including fair value changes on financial instruments - net, mainly consist of the net currency exchange changes and the fair value changes on convertible loans and warrants.
Other (losses)/gains including fair value changes on financial instruments - net Other (losses)/gains including fair value changes on financial instruments - net, mainly consist of the net foreign currency exchange changes, the fair value changes on warrants and convertible loans, gain on disposal of investment.
During the financial year ended December 31, 2023, net cash used in operating activities amounted to S$3.53 million.
During the financial year ended December 31, 2025, net cash used in operating activities amounted to S$3.70 million.
We expect that our research expenses will continue to increase in absolute amounts in the foreseeable future as we continue pre-clinical and clinical development for our product candidates and continue our advances in scientific research and product development. 114 Employee benefits expenses Employee benefits expenses were S$210,657 for the financial years ended December 31, 2022.
We expect that our research expenses will continue to increase in absolute amounts in the foreseeable future as we continue pre-clinical and clinical development for our product candidates and continue our advances in scientific research and product development. 117 Employee benefits expenses Employee benefits expenses were S$454,143 for the financial years ended December 31, 2023.
Funding Requirements Our plan of operation is to continue implementing our business strategy, continue R&D of CTM-N2D and our other product candidates and continue to expand our research pipeline and our internal R&D capabilities.
Funding Requirements Our plan of operation is to continue executing our business strategy, continue R&D of CTM-N2D and our other product candidates and expanding our research pipeline as well as our internal R&D capabilities.
For the financial year ending December 31, 2024, other expenses reduced by S$1.22 million to S$998,054. This reduction was primarily due to the absence of IPO related expenses of S$758,563, decrease in investor relations expenses by S$128,632, as well as a decrease in company insurance expenses by S$188,430.
This reduction was primarily due to the absence of IPO related expenses of S$758,563, decrease in investor relations expenses by S$128,632, as well as a decrease in company insurance expenses by S$188,430. For the financial year ending December 31, 2025, other expenses increased by S$672,559 to S$1.67 million.
Going forward, we expect to fund our working capital and other liquidity requirements from various sources, including but not limited to the net proceeds from our Offering and other equity and debt financings as and when appropriate.
Going forward, we expect to fund our working capital and other liquidity requirements from various sources, including but not limited to the net proceeds from our ATM offering as well as other equity and debt financings as and when appropriate. We do not have any equity line of credit facilities.
Interest rate risk As at December 31, 2023 and 2024, we had cash and bank balances of S$9.00 million and S$4.97 million. Our exposure to interest rate sensitivity is impacted by changes in the underlying U.S. bank interest rates. We have not entered into investments for trading or speculative purposes. B.
Interest rate risk As at December 31, 2024 and 2025, we had cash and bank balances of S$4.97 million and S$2.10 million. Our exposure to interest rate sensitivity is impacted by changes in the underlying U.S. bank interest rates. We have not entered into investments for trading or speculative purposes. We do not have any equity line of credit facilities.
With this acquisition, we started to generate revenue from the cord blood banking business segment. 112 Key Factor Affecting Our Results of Operations Our financial condition and results of operation have been and will continue to be affected by a number of factors, many of which may be beyond our control, including those factors set out in the section headed ‘‘Risk Factors’’ in this annual report and those set out below: No product candidates approved for commercial sale We are a clinical stage biopharmaceutical company and we do not have any products approved for commercial sale as of the date of this annual report.
In addition, we have expanded into the provision of private blood banking services, including the storage and processing of cord blood and immune cells in Malaysia. 115 Key Factor Affecting Our Results of Operations Our financial condition and results of operation have been and will continue to be affected by a number of factors, many of which may be beyond our control, including those factors set out in the section headed ‘‘Risk Factors’’ in this annual report and those set out below: No product candidates approved for commercial sale We are a clinical stage biopharmaceutical company and we do not have any products approved for commercial sale as of the date of this annual report.
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we conduct the ANGELICA Trial with National University Hospital Singapore, research collaboration with Sengkang General Hospital and advance the pre-clinical activities of our product candidates. In addition, we expect to incur additional costs associated with operating as a public company.
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we progress the ANGELICA Trial in collaboration with National University Hospital Singapore, advance our research collaboration with Universiti Malaya and continue the pre-clinical development of our product candidates. In addition, we anticipate incurring increased costs associated with operating as a public listed company.
To date, we have conducted the first in human Phase I clinical trial, ANGELICA Trial, using our first product candidate, CTM-N2D. Two patients have been successfully dosed with four weekly CTM-N2D at dose level 1. We foresee to recruit more patients in 2025.
To date, we have initiated a first in human (FIH) Phase I clinical trial, ANGELICA Trial, using our lead product candidate, CTM-N2D. Four patients have been successfully dosed with four weekly CTM-N2D at dose level 1 and two patients have been dosed at dose level 2.
We recorded a net other loss of S$1.12 million and S$492,910 for the financial years ended December 31, 2022 and 2023, respectively.
We recorded a net other loss of S$492,910 and net other gain of S$297,545 for the financial years ended December 31, 2023 and 2024, respectively.
The following table sets forth the breakdown of our other expenses for these periods: For the year ended December 31, 2022 2023 2024 S$ S$ S$ Advertising - 33,307 23,782 Annual listing fee - 64,370 87,279 Company insurance - 282,797 94,367 Entertainment 3,260 30,977 7,941 Investor relationship expenses - 204,808 76,176 Legal fees - 115,272 119,580 Low-value assets rental 2,201 1,703 3,215 Offering expenses 199,625 758,563 - Professional fees 184,253 396,915 405,420 Property tax 7,045 6,661 8,412 Printing and stationery 6,176 11,941 18,718 IT expenses 13,051 18,255 20,122 Repair and maintenance 8,720 3,728 13,926 Reversal of grant - 84,091 - Service fees 11,268 13,209 8,665 Subscription fee 2,165 1,083 873 Transportation and travelling expenses 3,364 144,998 62,758 Tools and supplies 3,516 2,333 7,195 Utilities 21,201 23,941 17,662 Others 28,830 14,190 21,963 Total 494,675 2,213,142 998,054 Other expenses were S$494,675 and S$2.21 million for the financial years ended December 31, 2022 and 2023, respectively.
The following table sets forth the breakdown of our other expenses for these periods: For the year ended December 31, 2023 2024 2025 S$ S$ S$ Advertising 33,307 23,782 54,374 Annual listing fee 64,370 87,279 94,521 Company insurance 282,797 94,367 - Entertainment 30,977 7,941 5,750 Investor relations expenses 204,808 76,176 486,824 Legal fees 115,272 119,580 101,365 Low-value assets rental 1,703 3,215 5,267 Offering expenses 758,563 - - Professional fees 396,915 405,420 366,296 Property tax 6,661 8,412 9,472 Printing and stationery 11,941 18,718 28,695 IT expenses 18,255 20,122 28,035 Repair and maintenance 3,728 13,926 21,768 Reversal of grant 84,091 - - Service fees 13,209 8,665 27,908 Share-based payment expenses - - 384,952 Subscription fee 1,083 873 1,608 Transportation and travelling expenses 144,998 62,758 25,427 Tools and supplies 2,333 7,195 1,774 Utilities 23,941 17,662 16,483 Others 14,190 21,963 10,094 Total 2,213,142 998,054 1,670,613 Other expenses were S$2.21 million and S$998,054 for the financial years ended December 31, 2023 and 2024, respectively.
The following table sets forth the breakdown of our research expenses for these periods: Year ended December 31, 2022 2023 2024 S$ S$ S$ Employee benefits expenses 500,038 642,533 737,524 Depreciation of property, plant and equipment 270,421 272,886 212,322 Amortization of intangible assets 10,700 4,209 642 Clinical trial expenses - 33,845 382,014 Consumables expenses 310,938 455,267 345,706 Royalty expenses 9,592 30,382 11,365 Professional fees 317,613 20,779 35,040 Electricity expenses 64,968 62,515 69,323 Others 38,495 67,277 115,583 Total 1,522,765 1,589,693 1,909,519 Research expenses were S$1.52 million for the financial year ended December 31, 2022, compared to S$1.59 million for the financial year ended December 31, 2023.
The following table sets forth the breakdown of our research expenses for these periods: Year ended December 31, 2023 2024 2025 S$ S$ S$ Employee benefits expenses 642,533 737,524 860,835 Depreciation of property, plant and equipment 272,886 212,322 174,146 Amortization of intangible assets 4,209 642 642 Clinical trial expenses 33,845 382,014 429,774 Consumables expenses 455,267 345,706 552,860 Royalty expenses 30,382 11,365 15,512 Professional fees 20,779 35,040 9,098 Utilities 62,515 69,323 62,357 Others 67,277 115,583 112,271 Total 1,589,693 1,909,519 2,217,495 Research expenses were S$1.59 million for the financial year ended December 31, 2023, compared to S$1.91 million for the financial year ended December 31, 2024.
We have not yet commercialized any of our product candidates, which are in various phases of pre-clinical development, and we do not expect to generate revenue from commercial sales of any products for the foreseeable future.
We have not yet commercialized any of our product candidates, which are in various phases of pre-clinical and clinical development, and we do not expect to generate revenue from commercial sales of any products for the foreseeable future. As at December 31, 2024 and 2025, we had S$4.97 million and S$2.10 million, respectively, in cash and bank balances.
Research income was derived from the manufacturing of limited quantities of cells for researchers and institutions on a non-profit, cost recovery basis for the purpose of research. Research income was S$363,912 and S$507,736 for the financials year ended December 31, 2022 and 2023, respectively.
For the financial year ended December 31, 2024, MRA grant amounted to S$15,447. Research income was generated from the manufacturing of limited quantities of cells for researchers and institutions on a non-profit, cost recovery basis, amounted to S$507,736 and S$433,871 for the financial years ended December 31, 2023 and 2024, respectively.
Share of loss of associate recognized by S$33,546 for the financial year ended December 31, 2022, while for the financial year ended December 31, 2023, share of loss of associate was recorded at S$31,198.
Share of loss of associate recognized by S$31,198 for the financial year ended December 31, 2023, while for the financial year ended December 31, 2023, share of gain of associate was recorded at S$13,765. For the financial year ended December 31, 2025, share of loss of S$6,391 was recorded before it was disposed in the year.
Contractual Obligations and Commitments The following table summarizes our contractual obligations and commitments as of December 31, 2024: Payment Due by Period Total Less than 1 year Between 1 and 2 years Between 2 and 5 years Over 5 years S$ S$ S$ S$ S$ Contractual Obligations: Bank borrowings (1)(2) 531,400 56,432 56,432 169,295 249,241 Lease liabilities (2) 34,020 9,494 9,494 15,032 - Commitment: Minimum royalty commitments 143,133 12,333 10,900 32,700 87,200 Loan commitments (3) 500,000 500,000 - - - (1) Includes scheduled outstanding principal payments as of December 31, 2024.
Contractual Obligations and Commitments The following table summarizes our contractual obligations and commitments as of December 31, 2025: Payment Due by Period Total Less than 1 year Between 1 and 2 years Between 2 and 5 years Over 5 years S$ S$ S$ S$ S$ Contractual Obligations: Bank borrowings (1)(2) 494,010 58,694 58,694 176,083 200,539 Lease liabilities (2) 79,821 22,408 22,408 35,005 - Commitment: Minimum royalty commitments 135,867 5,067 10,900 32,700 87,200 Loan commitments (3) 500,000 500,000 - - - (1) Includes scheduled outstanding principal payments as of December 31, 2025.
Cash Flows The following table summarizes our cash flows for the years presented: For the year ended December 31, 2022 2023 2024 S$ S$ S$ U.S.$ Net cash used in operating activities (1,398,409 ) (3,531,196 ) (2,709,929 ) (1,983,552 ) Net cash (used in)/generated from investing activities (473,305 ) (2,730,809 ) 1,126,541 824,580 Net cash generated from/(used in) financing activities 968,716 10,919,885 (64,892 ) (47,498 ) Net changes in cash and cash equivalents (902,998 ) 4,657,880 (1,648,280 ) (1,206,470 ) Cash and cash equivalents at beginning of year 2,512,768 1,579,718 6,224,187 4,555,839 Effect of foreign currency translation on cash and cash equivalents (30,052 ) (13,411 ) 121,140 88,669 Cash and cash equivalents at end of year 1,579,718 6,224,187 4,697,047 3,438,038 116 Operating Activities During the financial year ended December 31, 2022, net cash used in operating activities amounted to S$1.40 million.
Cash Flows The following table summarizes our cash flows for the years presented: For the year ended December 31, 2023 2024 2025 S$ S$ S$ U.S.$ Net cash used in operating activities (3,531,196 ) (2,709,929 ) (3,697,463 ) (2,875,389 ) Net cash (used in)/generated from investing activities (2,730,809 ) 1,126,541 929,283 722,671 Net cash generated from/(used in) financing activities 10,919,885 (64,892 ) 208,648 162,258 Net changes in cash and cash equivalents 4,657,880 (1,648,280 ) (2,559,532 ) (1,990,460 ) Cash and cash equivalents at beginning of year 1,579,718 6,224,187 4,697,047 3,652,731 Effects of foreign currency translation on cash and cash equivalents (13,411 ) 121,140 (42,026 ) (32,682 ) Cash and cash equivalents at end of year 6,224,187 4,697,047 2,095,489 1,629,589 119 Operating Activities During the financial year ended December 31, 2023, net cash used in operating activities amounted to S$3.53 million.
For the financial year ended December 31, 2024, research income decreased to S$433,871, mainly because of the decrease in demand from the researchers and institutions. Interest income was S$2,097 and S$285,719 for the financial year ended December 31, 2022 and 2023, respectively.
For the financial year ended December 31, 2025, research income increased by 23.6% to S$536,461, mainly due to higher demand from the researchers and institutions. Interest income was S$285,719 and S$317,670 for the financial year ended December 31, 2023 and 2024, respectively.
For the financial year ended December 31, 2024, we recorded a net other gain of S$297,545, due to gains in net currency exchange and a fair value gain on warrant liabilities. 113 Research Expenses Our research expenses consist primarily of costs incurred for our research, pre-clinical and clinical activities. We expense research costs as incurred.
For the financial year ended December 31, 2025, we recorded a net other gain of S$140,318, mainly attributable to a gain of S$294,236 from the disposal of an investment in an associate, partially offset by a foreign exchange loss of S$132,291 and a fair value loss on the warrant liabilities of S$13,119. 116 Research Expenses Our research expenses consist primarily of costs incurred for our research, pre-clinical and clinical activities.
Other expenses also include, inter alia , professional fees for legal, auditing, tax and consulting services, and other expenses that are not attributable to R&D activities.
Other Expenses Other expenses consist mainly of Offering expenses and costs associated with being a public listed company, including annual listing fee, directors’ and officers’ insurance and investor relations expenses. Other expenses also include, inter alia , professional fees for legal, auditing, tax and consulting services, and other expenses that are not attributable to R&D activities.
As at December 31, 2023 and 2024, we had S$9.00 million and S$4.97 million, respectively, in cash and bank balances. Our liquidity and working capital requirements primarily related to our operating expenses. Historically, we have funded our operations primarily through private equity financing and issuance of convertible loans.
Our liquidity and working capital requirements primarily related to our operating and R&D expenses. Historically, we have funded our operations primarily through proceeds from our Offerings, private equity financing and issuance of convertible loans.
This was primarily attributable to the loss for the year of S$3.13 million, adjusted for non-cash charges of S$1.46 million for depreciation and amortization, fair value loss on convertible loans and unrealized currency translation gains, S$125,175 in interest expenses, S$2,097 in interest income, S$33,546 in share of results of associate and a S$109,902 net change in working capital.
This was primarily attributable to the loss for the year of S$4.00 million, adjusted for non-cash charges of S$459,389 for depreciation and amortization and unrealized currency translation losses, share-based payment expenses of S$694,200, a gain on disposal of investment in an associate of S$294,236, interest income of S$123,898 and a net change in working capital of S$485,506.
Our second product candidate, iPSC-gdNKT, has been undergoing pre-clinical process development since the fourth quarter of 2022 and is targeting to commence pre-clinical studies after the fourth quarter of 2025. Through a US agent, we have submitted a drug master file to the US FDA for our third product candidate, CTM-GDT.
As of the date of this annual report, the ANGELICA Trial is ongoing, and we expect to continue patient recruitment in 2026. Our second product candidate, iPSC-gdNKT, has been undergoing pre-clinical process development since the fourth quarter of 2022 and we are targeting to commence pre-clinical studies after the second quarter of 2026.
The following table sets forth the breakdown of our other operating income for these periods: Year ended December 31, 2022 2023 2024 S$ S$ S$ Government grants: Wage Subsidy Program 3,099 - - Enterprise Development Grant 8,640 - - Jobs Growth Incentive 5,550 - - Hiring Incentive and Training Programme 9,077 3,459 - Startup SG Tech - Proof-of-concept grant 84,091 - - Market Readiness Assistance Grant - - 15,447 Others 2,880 4,112 11,715 Research income 363,912 507,736 433,871 Interest income 2,097 285,719 317,670 Others 6,028 2,878 5,358 Total 485,374 803,904 784,061 The Hiring Incentive and Training Programme (“Hiring Incentive”) was an economic recovery incentive introduced in Malaysia to promote job creation among employers while increasing employment prospects.
The following table sets forth the breakdown of our other operating income for these periods: For the Year ended December 31, 2023 2024 2025 S$ S$ S$ Government grants: Hiring Incentive and Training Programme 3,459 - - Market Readiness Assistance Grant - 15,447 - BeST 2.0 - - 4,901 Others 4,112 11,715 3,530 Research income 507,736 433,871 536,461 Interest income 285,719 317,670 123,898 Rental income - - 8,423 Others 2,878 5,358 2,503 Total 803,904 784,061 679,716 The Market Readiness Assistance (“MRA”) grant helps companies expand into new markets overseas by defraying the costs of overseas market promotion, business development and set-up.
For the financial year ended December 31, 2024, we started generating revenue mainly from providing private blood banking services amounting to S$69,501 after acquiring the license and certain assets of Cellsafe International Sdn Bhd (In Liquidation). Other Operating Income Other operating income amounted to S$485,374, S$803,904 and S$784,061 for the financial years ended December 31, 2022, 2023 and 2024, respectively.
For the Year ended December 31, 2023 2024 2025 S$ S$ S$ Over time Revenue from private blood banking services - 64,214 279,661 At a point of time Revenue from retrieval and enrolment of private blood banking services - 5,287 44,726 Total - 69,501 324,387 Other Operating Income Other operating income amounted to S$803,904, S$784,061 and S$679,716 for the financial years ended December 31, 2023, 2024 and 2025, respectively.
As of the date of this annual report, we are finalizing the dossier for a Phase I clinical trial using our fourth product candidate, CTM-MSC to treat osteoarthritis and target for submission in second half of 2025.
As of the date of this annual report, our clinical partner, Sengkang General Hospital, is preparing to submit an application to the Institutional Review Board (IRB) to initiate a Phase I clinical trial evaluating our fourth product candidate, CTM-MSC, for the treatment of osteoarthritis.
Financing Activities During the financial year ended December 31, 2022, net cash generated from financing activities was S$968,716 mainly due to the proceeds from issuance of ordinary shares of S$1.22 million, proceeds from a third party loan of S$300,000.
During the financial year ended December 31, 2025, net cash generated from financing activities was S$208,648 mainly due to the net proceeds from issuance of ordinary shares of S$283,094 pursuant to the ATM offering program, offset by the repayment of bank borrowings of S$38,494 and interest payment of S$20,906.
However, for the financial year ended December 31, 2024, the associate generated a profit, resulting in a recorded share of profit of S$13,765. 115 Loss for the year As a result of the foregoing, we had loss of S$3.13 million, S$4.13 million and S$2.52 million for the financial years ended December 31, 2022, 2023 and 2024, respectively.
Accordingly, the Group recognized a gain on disposal of S$294,236 in profit or loss. 118 Loss for the year As a result of the foregoing, we incurred a net loss of S$2.52 million for the financial year ended December 31, 2024 as compared to a net loss of S$4.00 million for the financial year ended December 31, 2025.
If the costs associated with being a public listed company of S$257,311 are excluded, the loss for the year will be reduced to S$2.26 million (approximately to US$1.66 million). We expect to continue to incur losses for the foreseeable future in connection with our ongoing activities.
Excluding non-cash share-based payment expenses of S$694,200 and costs associated with being a public listed company of S$581,345, our loss for the financial year ended December 31, 2025 would have been reduced to S$2.72 million (approximately to US$2.12 million). We expect to continue incurring losses for the foreseeable future as we advance our research and development activities.
To date, there have not been any material adjustments to our prior estimates of accrued R&D expenses. D. Trend Information See “Item 5A. Operating Results” within this annual report. E. Critical Accounting Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with IFRS.
To date, there have not been any material adjustments to our prior estimates of accrued R&D expenses. D. Trend Information See “
Employee benefits expenses increased by S$165,184 from S$454,143 for the financial year ended December 31, 2023 to S$619,327 for the financial year ended December 31, 2024, mainly driven by the increase in headcount and employee salary rates. Finance Expenses Finance expenses consisted interest expenses on bank borrowing, convertible loans, third party loans and lease liabilities.
This was the first share award issued since the Company’s Offering. Finance Expenses Finance expenses consisted interest expenses on bank borrowing, lease liabilities, convertible loans and third party loans. Finance expenses were S$51,282 for the financial years ended December 31, 2023.
Investing Activities Net cash used in investing activities during the financial year ended December 31, 2022 was S$473,305, mainly due to the purchase of property, plant and equipment of S$473,795.
Net cash generated from investing activities during the financial year ended December 31, 2025 was S$929,283, mainly due to proceeds of S$700,000 from dilution of interest in a subsidiary, proceeds from disposal of an associate of S$517,440 and the withdrawal of fixed deposit of S$273,320. This was partially offset by the purchase of plant and equipment of S$637,850.
For the financial year ended December 31, 2024, interest income increased by 11.2% to S$317,670 compared to the previous year, primarily due to the longer tenure of fixed deposit placements using proceeds from the Offering.
For the financial year ended December 31, 2025, interest income declined by 61.0% to S$123,898, mainly due to the withdrawal of fixed deposit during the year.
Removed
We intend to pursue an investigational new drug application in the near future. We are also collaborating with The University of Texas M.D. Anderson Cancer Center on preclinical studies evaluating CTM-GDT for lymphoma and breast cancer. In India, an investigator-initiated clinical trial has been registered with the Clinical Trials Registry – India to evaluate CTM-GDT in solid tumors and lymphomas.
Added
Through a US agent, we have submitted a drug master file to the U.S. FDA for our third product candidate, CTM-GDT and we intend to pursue an investigational new drug (IND) application in the near future.
Removed
On April 18, 2023, we completed our Offering, whereby we issued and sold 2,412,369 ordinary shares at a price to the public of U.S.$4.00 per share for aggregate gross proceeds of S$12.94 million. We received S$10.31 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.
Added
We have also announced the publication of a preclinical study in a research article entitled “ Donor-Derived Vγ9Vδ2 T Cells for Acute Myeloid Leukemia: A Promising ‘Off-the-Shelf’ Immunotherapy Approach ”.
Removed
By last quarter of 2024, we completed the acquisition of certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank through our subsidiary, LongevityBank Pte Ltd.
Added
The study, arising from a collaborative research effort with The University of Texas MD Anderson Cancer Center (MDACC), suggests the promising potential of our CTM-GDT for the treatment of acute myeloid leukemia (AML). In addition, we are targeting the commencement of a FIH Phase I clinical trial in Malaysia in collaboration with Universiti Malaya in the second half of 2026.
Removed
The acquisition included (i) a private blood bank license for provision of umbilical cord blood stem cell banking business issued by MOH Malaysia, (ii) cryopreservation equipment with more than 12,000 cord blood units (“CBUs”) and (iii) two freehold real estate properties measuring a total of 189 square metres in area in which the cord blood stem cell banking facility is situated.
Added
Our fifth product candidate, CTM-NK, is developed by isolating and expanding allogeneic immune natural killer (NK) cells from donor-sourced peripheral blood (PB) and umbilical cord blood (CB) to potentially treat immuno-senescence, auto-immune diseases, and a broad range of cancers.
Removed
The income was primarily consisted government grants received in view of the COVID-19 pandemic as well as support in relation to the technology innovation and overseas expansion, research income and interest income.
Added
We have recently obtained an Enterprise Development Grant (EDG) from Enterprise Singapore to support the R&D of this project till the pre-clinical stage.
Removed
For the financial years ended December 31, 2022, 2023 and 2024, the Hiring Incentive amounted to S$9,077, S$3,459, and Nil respectively. The Startup SG Tech - Proof-of-concept (“SSG Tech POC”) grant is a scheme to drive the growth of startups based on proprietary technology and to foster the spirit of deep-tech innovation among startups.
Added
Since the financial year ended December 31, 2024, we have commenced revenue generation mainly from the provision of private blood banking services.
Removed
Under the scheme, qualifying companies may receive early-stage funding for developing and commercializing the innovations. For the financial year ended December 31, 2022, SSG Tech POC grant amounted to S$84,091 and the development project was terminated during the financial year ended December 31, 2023.
Added
The income was primarily consisted of research income and interest income.
Removed
The Market Readiness Assistance (“MRA”) grant helps companies expand into new markets overseas by defraying the costs of overseas market promotion, business development and set-up. For the financial year ended December 31, 2024, MRA grant amounted to S$15,447.
Added
For the financial year ended December 31, 2025, research expenses increased by S$307,976, primarily driven by higher consumable expenses of S$207,154, increased employee benefits of S$123,311 and higher clinical trial expenses of S$47,760. This increase was partially offset by lower depreciation expenses of S$38,176 and reduced professional fees of S$25,942.
Removed
For the financial year ended December 31, 2024, research expenses increased by S$319,826, primarily attributable to the increase in clinical trial expenses by S$348,169, higher employee benefits by S$94,991 resulting from increase in headcount and employee salary rates. This was partially offset by the decrease in consumables expenses by S$109,561. Our R&D activities are central to our business.
Added
The rise in clinical trial costs was moderated by co-funding support for the ANGELICA Trial from the Ministry of Health Singapore through the NMRC Clinical Trial Grant Industry Collaborative Trials scheme (MOH-001646). Our R&D activities are central to our business.
Removed
Finance expenses were S$125,175 for the financial years ended December 31, 2022. Finance expenses decreased by S$30,969 from S$51,282 for the financial year ended December 31, 2023 to S$20,313 for the financial year ended December 31, 2024.
Added
Employee benefits expenses increased by S$311,237 from S$619,327 for the financial year ended December 31, 2024 to S$930,564 for the financial year ended December 31, 2025, mainly driven by the share-based compensation of S$309,248 to certain employees in recognition of the contributions made to the development and growth of the Group’s business.
Removed
This is mainly resulted from the absent of convertible loans interest as the convertible loans were converted into ordinary shares during the financial year ended December 31, 2023. Other Expenses Other expenses consist mainly of Offering expenses and costs associated with being a public listed company, including annual listing fee, directors’ and officers’ insurance and investor relationship expenses.
Added
Finance expenses increased by S$593 from S$20,313 for the financial year ended December 31, 2024 to S$20,906 for the financial year ended December 31, 2025. This increase is due to higher lease liabilities of S$1,968, offset by a reduction in bank borrowings of S$1,375.
Removed
The increase was mainly due to the increase in Offering expenses by S$558,938, costs associated with being a public listed of S$550,746, higher professional fees by S$212,662, higher transportation and travelling expenses by S$141,634, higher legal fees by S$115,272 and the reversal of SSG Tech POC grant of S$84,091.
Added
This increase was mainly due to higher investor relations expenses of S$410,648 and the recognition of share-based payment expenses of S$384,952 in 2025. This increase was partially offset the absence of company insurance expenses of S$94,367 in 2025 and lower professional fees of S$39,124.
Removed
However, our cash position remains strong with S$4.97 million cash and bank balances as at December 31, 2024 which enables us to support the R&D activities, including the ANGELICA Trial and the research collaboration with Sengkang General Hospital considering our low-cost structure.
Added
The Group received cash consideration of S$517,440 (equivalent to RM1.65 million) for the disposal. The carrying amount of the investment at the date of disposal was S$223,204.
Removed
As at December 31, 2023 and 2024, we had accumulated losses of S$12.33 million and S$14.85 million, respectively and net cash used in operating activities of S$3.53 million and S$2.71 million, respectively.
Removed
We expect that our expenses and capital requirements will increase significantly in connection with our ongoing activities as we continue to develop and seek regulatory approvals for our product candidates, engage in other R&D activities to expand our pipeline of product candidates, maintain and expand our intellectual property portfolio, and ultimately establish a sales organization and operate as a public company.
Removed
This was partially offset by the repayment of a third party loan of S$350,000, interest payment of S$125,175 and repayment of bank borrowings of S$71,204.
Removed
The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our financial statements.
Removed
We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis.
Removed
Our actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in greater detail in Note 2 to our financial statements in this annual report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Removed
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements in this annual report. 119 Emerging Growth Company Status We are an “emerging growth company” under the JOBS Act.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

34 edited+9 added−7 removed98 unchanged
If shares delivered under the Incentive Plan are tendered or withheld to pay the exercise price of a share option or to satisfy withholding taxes, such shares will again become available for issuance under the Incentive Plan. 129 Administration of the Incentive Plan Our Board or a committee appointed by the Board will administer the Incentive Plan as the plan administrator and will have broad authority to: ● select participants and determine the types of awards that they are to receive; ● determine the number of shares that are to be subject to awards and the terms and conditions of awards, including the price (if any) to be paid for the shares or the award and establish the vesting conditions (if applicable) of such shares or awards; ● cancel, modify or waive our rights with respect to, or modify, discontinue, suspend or terminate any or all outstanding awards, subject to any required consents; ● construe and interpret the terms of the Incentive Plan and any agreements relating to the Incentive Plan; ● determine whether awards will be settled in cash, ordinary shares, other securities, other property, or in any combination thereof; ● prescribe, amend, and rescind rules and regulations relating to the Incentive Plan; and ● make all other determinations deemed necessary or advisable for administering the Incentive Plan.
If shares delivered under the Incentive Plan are tendered or withheld to pay the exercise price of a share option or to satisfy withholding taxes, such shares will again become available for issuance under the Incentive Plan. 131 Administration of the Incentive Plan Our Board or a committee appointed by the Board will administer the Incentive Plan as the plan administrator and will have broad authority to: ● select participants and determine the types of awards that they are to receive; ● determine the number of shares that are to be subject to awards and the terms and conditions of awards, including the price (if any) to be paid for the shares or the award and establish the vesting conditions (if applicable) of such shares or awards; ● cancel, modify or waive our rights with respect to, or modify, discontinue, suspend or terminate any or all outstanding awards, subject to any required consents; ● construe and interpret the terms of the Incentive Plan and any agreements relating to the Incentive Plan; ● determine whether awards will be settled in cash, Ordinary Shares, other securities, other property, or in any combination thereof; ● prescribe, amend, and rescind rules and regulations relating to the Incentive Plan; and ● make all other determinations deemed necessary or advisable for administering the Incentive Plan.
We also require each of our Directors and executive officers to complete a Directors’ and officers’ questionnaire that elicits information about related party transactions. These procedures are intended to determine whether any such related party transaction impairs the independence of a Director or presents a conflict of interest on the part of a Director, employee or officer. C.
We also require each of our Directors and executive officers to complete a Directors’ and officers’ questionnaire that elicits information about related party transactions. These procedures are intended to determine whether any such related party transaction impairs the independence of a Director or presents a conflict of interest on the part of a Director, employee or officer. 134 C.
Term The Incentive Plan, unless terminated, will continue in effect for a term of ten (10) years from January 18, 2023, the date the Incentive Plan was adopted by the Board. 130 Amendment and Termination The Board may at any time amend, alter, suspend or terminate the Incentive Plan, although no such action may, without the written consent of the participant, impair the rights of any participant with respect to outstanding awards.
Term The Incentive Plan, unless terminated, will continue in effect for a term of ten (10) years from January 18, 2023, the date the Incentive Plan was adopted by the Board. 132 Amendment and Termination The Board may at any time amend, alter, suspend or terminate the Incentive Plan, although no such action may, without the written consent of the participant, impair the rights of any participant with respect to outstanding awards.
None of our executive officers serve as a member of the Board or compensation committee of any entity that has one or more executive officers serving as a member of our Board or on our compensation committee. 128 Duties of Directors Under Singapore law, directors of a Singapore company owe certain fiduciary duties towards the company, including a duty to act in good faith in the best interests of the company, a duty to act honestly and to use reasonable diligence in the discharge of the duties of their office.
None of our executive officers serve as a member of the Board or compensation committee of any entity that has one or more executive officers serving as a member of our Board or on our compensation committee. 130 Duties of Directors Under Singapore law, directors of a Singapore company owe certain fiduciary duties towards the company, including a duty to act in good faith in the best interests of the company, a duty to act honestly and to use reasonable diligence in the discharge of the duties of their office.
Choo resigned as a non-executive director and chairman of Falmac on August 29, 2011. Subsequently in or around August 2013, a creditor petitioned to the Singapore High Court to wind up Falmac and the winding up order was granted on May 15, 2014. 121 Dr. ZENG Jieming, M.D., Ph.D . , is one of our scientific founders.
Choo resigned as a non-executive director and chairman of Falmac on August 29, 2011. Subsequently in or around August 2013, a creditor petitioned to the Singapore High Court to wind up Falmac and the winding up order was granted on May 15, 2014. 124 Dr. ZENG Jieming, M.D., Ph.D . , is one of our scientific founders.
A copy of the Clawback Policy has been incorporated by reference herewith as Exhibit 97.1. 126 C. Board Practices Board of Directors Our Board consists of 6 directors, including 2 executive (non-independent) directors and 4 independent directors. We established an Audit Committee, a Nominating and Corporate Governance Committee and a Compensation Committee on April 18, 2023.
A copy of the Clawback Policy has been incorporated by reference herewith as Exhibit 97.1. 129 C. Board Practices Board of Directors Our Board consists of 6 directors, including 2 executive (non-independent) directors and 4 independent directors. We established an Audit Committee, a Nominating and Corporate Governance Committee and a Compensation Committee on April 18, 2023.
Prior to that, Ms. Goh held accounting roles in various private companies. Ms. Goh is a Chartered Accountant (CA) of the Institute of Singapore Chartered Accountants (ISCA) since 2016. We believe that Ms. Goh’s broad operational management experience in listed companies and experience in accounting qualifies her to serve as our Chief Financial Officer. 122 Ms.
Prior to that, Ms. Goh held accounting roles in various private companies. Ms. Goh is a Chartered Accountant (CA) of the Institute of Singapore Chartered Accountants (ISCA) since 2016. We believe that Ms. Goh’s broad operational management experience in listed companies and experience in accounting qualifies her to serve as our Chief Financial Officer. 125 Ms.
The information is not necessarily indicative of beneficial ownership for any other purpose. 131 Except as otherwise indicated in the table below, addresses of our directors, executive officers and 5% or greater beneficial owners are in care of CytoMed Therapeutics Limited, 1 Commonwealth Lane, #08-22, Singapore 149544.
The information is not necessarily indicative of beneficial ownership for any other purpose. 133 Except as otherwise indicated in the table below, addresses of our directors, executive officers and 5% or greater beneficial owners are in care of CytoMed Therapeutics Limited, 1 Commonwealth Lane, #08-22, Singapore 149544.
With deep interest in research, LMC has been purchasing small quantities of R&D products from us since beginning of 2020.
With deep interest in research, LMC has been purchasing small quantities of R&D products from us since 2020.
Yew received his M.SC in Regenerative Medicine from UCSI University (Malaysia) in 2014, and M.B.B.S from University of Malaya (Malaysia) in 2007. We believe that Dr. Yew’s record in practice of medical practice and his broad understanding of regenerative medicine qualifies him to serve on our Board. 123 Mr.
Yew received his M.SC in Regenerative Medicine from UCSI University (Malaysia) in 2014, and M.B.B.S from University of Malaya (Malaysia) in 2007. We believe that Dr. Yew’s record in practice of medical practice and his broad understanding of regenerative medicine qualifies him to serve on our Board. 126 Mr.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Board of Directors The following table sets forth information regarding the current members of our Board of Directors as of the date hereof. Name Age Position/Title Executive Directors CHOO Chee Kong 67 Director and Chairman Dr.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management Board of Directors The following table sets forth information regarding the current members of our Board of Directors as of the date hereof. Name Age Position/Title Executive Directors CHOO Chee Kong 68 Director and Chairman Dr.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of the date of this annual report for: ● each beneficial owner of 5% or more of our outstanding ordinary shares; ● each of our directors and NEOs; and ● all of our directors and NEOs as a group.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our Ordinary Shares as of the date of this annual report for: ● each beneficial owner of 5% or more of our outstanding Ordinary Shares; ● each of our directors and executives; and ● all of our directors and executives as a group.
Toh’s decades of experience in haematology and managerial experience as a medical director qualifies him to serve on our Board. 124 Family Relationships There are no family relationships or other arrangements among our Directors and executive officers.
Toh’s decades of experience in haematology and managerial experience as a medical director qualifies him to serve on our Board. 127 Family Relationships There are no family relationships or other arrangements among our Directors and executive officers.
We maintain a good working relationship with our employees and we have not experienced any labor disputes. Incentive Plan For future equity awards, our Board has adopted the Incentive Plan to provide an additional means through which to the grant of awards to attract, motivate, retain and reward selected key employees and other eligible persons, including our NEOs.
We maintain a good working relationship with our employees and we have not experienced any labor disputes. Incentive Plan For future equity awards, our Board has adopted the Incentive Plan to provide an additional means through which to the grant of awards to attract, motivate, retain and reward selected key employees and other eligible persons, including our executive officers.
(2) Member of the Audit Committee and Compensation Committee. (3) Audit Committee financial expert, Chair of the Audit Committee and Chair of the Compensation Committee. (4) Chair of the Nominating and Corporate Governance Committee and Member of the Audit Committee. 120 Executive Officers The following table sets forth information regarding our current executive officers as of the date thereof.
(2) Member of the Audit Committee and Compensation Committee. (3) Audit Committee financial expert, Chair of the Audit Committee and Chair of the Compensation Committee. (4) Chair of the Nominating and Corporate Governance Committee and Member of the Audit Committee. 123 Executive Officers The following table sets forth information regarding our current executive officers as of the date thereof.
Each of our NEOs has agreed to be bound by restrictive covenants governing confidentiality, a non-solicitation and non-competition restriction that applies to employees, client, customers and executives for one year following termination, and confirmation that all intellectual property developed during the term of his employment belongs exclusively to the Company.
Each of our executive officers has agreed to be bound by restrictive covenants governing confidentiality, a non-solicitation and non-competition restriction that applies to employees, client, customers and executives for one year following termination, and confirmation that all intellectual property developed during the term of his employment belongs exclusively to the Company.
No options were issued to date. E. Share Ownership Please see Item 7. Major Shareholders and Related Party Transactions of this annual report for information relating to ownership of our securities by our directors, officers and certain major shareholders. F. DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION. Not Applicable. ITEM 7.
No options were issued to date. E. Share Ownership Please see “ Item 7. Major Shareholders and Related Party Transactions” of this annual report for information relating to ownership of our securities by our directors, officers and certain major shareholders. F. DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION. Not Applicable. ITEM 7.
Leong is a Fellow of the Association of Chartered Certified Accountants (“ACCA”), a Chartered Accountant of the Institute of Singapore Chartered Accountants (“ISCA”) and a Member of the Singapore Institute of Directors (“SID”). We believe that Mr.
Leong is a Fellow of the Association of Chartered Certified Accountants (“ACCA”), a Chartered Accountant of the Institute of Singapore Chartered Accountants (“ISCA”), an ASEAN CPA and a Member of the Singapore Institute of Directors (“SID”). We believe that Mr.
Our Board has determined that Mark LEONG Kei Wei is an “audit committee financial expert” as defined by applicable SEC rules and the Nasdaq Listing Rules and regulations. 127 The Board has adopted an audit committee charter, which details the principal functions of the audit committee, including the following: ● general oversight of the integrity of our financial statements, qualifications and independence of our independent auditors and internal financial and accounting controls; ● appointing, approving compensation arrangements, retaining, evaluating, terminating and overseeing our independent registered public accounting firm; ● reviewing and discussing with our independent registered public accounting firm its independence from us; ● reviewing with our independent registered public accounting firm the matters required to be reviewed by applicable auditing requirements; ● approving all audit and permissible non-audit services to be performed by our independent registered public accounting firm; ● overseeing the financial reporting process and discussing with management and our independent registered public accounting firm the interim and annual financial statements that we file with the SEC and ACRA; ● reviewing and approving related person transactions; ● reviewing and monitoring our internal controls, disclosure controls and procedures and compliance with legal and regulatory requirements; and ● establishing procedures for the confidential, anonymous submission of concerns regarding questionable accounting, internal accounting controls, and auditing matters.
The Board has adopted an audit committee charter, which details the principal functions of the audit committee, including the following: ● general oversight of the integrity of our financial statements, qualifications and independence of our independent auditors and internal financial and accounting controls; ● appointing, approving compensation arrangements, retaining, evaluating, terminating and overseeing our independent registered public accounting firm; ● reviewing and discussing with our independent registered public accounting firm its independence from us; ● reviewing with our independent registered public accounting firm the matters required to be reviewed by applicable auditing requirements; ● approving all audit and permissible non-audit services to be performed by our independent registered public accounting firm; ● overseeing the financial reporting process and discussing with management and our independent registered public accounting firm the interim and annual financial statements that we file with the SEC and ACRA; ● reviewing and approving related person transactions; ● reviewing and monitoring our internal controls, disclosure controls and procedures and compliance with legal and regulatory requirements; and ● establishing procedures for the confidential, anonymous submission of concerns regarding questionable accounting, internal accounting controls, and auditing matters.
Name Age Position/Title CHOO Chee Kong 67 Chairman and Director Dr. ZENG Jieming 52 Chief Scientific and Medical Officer and Director Dr. Lucas LUK Tien Wee 41 Chief Clinical Officer GOH Yvonne 36 Chief Financial Officer TAN Yoong Ying 37 Chief Corporate Officer The following sets forth certain biographical information with respect to our Directors and executive officers.
Name Age Position/Title CHOO Chee Kong 68 Chairman and Director Dr. ZENG Jieming 53 Chief Scientific and Medical Officer and Director Dr. Lucas LUK Tien Wee 42 Chief Clinical Officer GOH Yvonne 37 Chief Financial Officer TAN Yoong Ying 38 Chief Corporate Officer The following sets forth certain biographical information with respect to our Directors and executive officers.
ZENG Jieming 52 Director and Chief Scientific and Medical Officer Independent Directors Prof. LOH Yuin Han (1) 48 Independent Director Dr. YEW Chak Hua (2) 44 Independent Director Mark LEONG Kei Wei (3) 49 Independent Director Dr. TOH Keng Kiat (4) 84 Independent Director (1) Member of the Nominating and Corporate Governance Committee.
ZENG Jieming 53 Director and Chief Scientific and Medical Officer Independent Directors Prof. LOH Yuin Han (1) 49 Independent Director Dr. YEW Chak Hua (2) 45 Independent Director Mark LEONG Kei Wei (3) 50 Independent Director Dr. TOH Keng Kiat (4) 85 Independent Director (1) Member of the Nominating and Corporate Governance Committee.
Employees As of the date of this Report, we have forty-three (43) full-time employees. Of these employees, twenty-eight (28) employees are engaged in our R&D and manufacturing activities. The rest of our employees carry out office administration and finance functions. Our operations are currently managed by Chief Scientific and Medical Officer, Dr. ZENG Jieming.
Employees As of the date of this Report, we have forty-two (42) full-time employees. Of these employees, thirty-four (34) employees are engaged in our R&D and manufacturing activities. The rest of our employees carry out office administration and finance functions. Our operations are currently managed by Chief Scientific and Medical Officer, Dr. ZENG Jieming.
Percentage ownership calculations are based on 11,540,000 ordinary shares, outstanding as of the date of this annual report. Except as otherwise indicated, all of the shares reflected in the table are ordinary shares and all persons listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community property laws.
Percentage ownership calculations are based on 11,828,435 Ordinary Shares, outstanding as of December 31, 2025. Except as otherwise indicated, all of the shares reflected in the table are Ordinary Shares and all persons listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community property laws.
The subscription of shares in LMC was completed on September 6, 2021. Dr Lucas LUK Tien Wee, one of the shareholders of LMC and a partyies of to the investment agreement, was appointed a Director of our Company on January 1, 2021 and resigned from the board on May 15, 2024.. He currently serves as our Chief Clinical Officer.
The subscription of shares in LMC was completed on September 6, 2021. Dr. Lucas LUK Tien Wee, a shareholders and Chief Executive Officer of LMC, served as a Director of the Company from January 1, 2021 to May 15, 2024, and currently serves as Chief Clinical Officer.
Each NEO has agreed to hold in strict confidence and not to use, except for the benefit of our Company, any proprietary information, technical data, trade secrets and know-how of our Company or the confidential or proprietary information of any third party, including our subsidiaries and our clients, received by our Company.
We may immediately terminate in the event of default, misconduct or any breach or non-observance by the employee. 128 Each executive officer has agreed to hold in strict confidence and not to use, except for the benefit of our Company, any proprietary information, technical data, trade secrets and know-how of our Company or the confidential or proprietary information of any third party, including our subsidiaries and our clients, received by our Company.
The aggregate amounts of such transactions for the three-year period ended December 31, 2024 are as follows: 2022 2023 2024 S$ S$ S$ Research income from LMC 207,206 183,518 115,277 Policies and Procedures for Related Party Transactions Effective on April 18, 2023, we adopted a code of business conduct and ethics requiring us to avoid, wherever possible, all conflicts of interests, except under guidelines or resolutions approved by our Board (or the appropriate committee of our Board) or as disclosed in our public filings with the SEC.
Policies and Procedures for Related Party Transactions Effective on April 18, 2023, we adopted a code of business conduct and ethics requiring us to avoid, wherever possible, all conflicts of interests, except under guidelines or resolutions approved by our Board (or the appropriate committee of our Board) or as disclosed in our public filings with the SEC.
We have also obtained approval for the Incentive Plan from our shareholders. A summary of our Incentive Plan is set out below. Shares Subject to the Incentive Plan A total of 1,279,117 ordinary shares will be available for issuance under the Incentive Plan.
We have also obtained approval for the Incentive Plan from our shareholders. A summary of our Incentive Plan is set out below. Shares Subject to the Incentive Plan As of the date of this report, 130,431 Ordinary Shares have been issued under the Incentive Plan. A total of 1,148,686 Ordinary Shares are available for future issuance under the Incentive Plan.
Under our code of business conduct and ethics, conflict of interest situations include any financial transaction, arrangement or relationship (including any indebtedness or guarantee of indebtedness) involving the Company.
Under our code of business conduct and ethics, conflict of interest situations include any financial transaction, arrangement or relationship (including any indebtedness or guarantee of indebtedness) involving the Company. Our code of business conduct and ethics as adopted has been incorporate by reference herewith as Exhibit 11.1 to this annual report.
Choo disclaims beneficial ownership of 1,697,981 ordinary shares held by Glorious Finance to the extent that he does not have an economic interest therein; (b) 410,515 ordinary shares held by EP Capital Inc. (“EP Capital”). Mr. Choo is deemed to beneficially own the 410,515 ordinary shares held by EP Capital, and (c) 187,500 ordinary shares held directly by Mr. Choo.
CHOO Chee Kong (“Mr. Choo”) owns 55.0% of shares in Glorious Finance. Mr. Choo disclaims beneficial ownership of 1,697,981 Ordinary Shares held by Glorious Finance to the extent that he does not have an economic interest therein; (b) 194,112 Ordinary Shares held by EP Capital Inc. (“EP Capital”). Mr.
Related Party Transactions Other than compensation arrangements for our Directors and executive officers, which are described elsewhere in this annual report, the following includes a summary of transactions since our incorporation since January 1, 2022, and up through April 28, 2025, to which we were or are to be a participant, in which: ● the amount involved exceeded or will exceed the lesser of (1) U.S.$120,000 or (2) 1% of the average of our total assets; and ● any of our Directors, executive officers or holders of more than 5% of our ordinary shares, or member of the immediate family of, or person sharing the household with, the foregoing persons, had or will have a direct or indirect material interest. 132 Transactions with Landmark Medical Centre Sdn Bhd (“LMC”) On January 20, 2020, we entered into an investment agreement with, inter alia , LMC, as subsequently varied by a supplemental agreement dated January 20, 2021 and a further supplemental letter dated October 28, 2021, to acquire new ordinary shares representing 20.0% of the total number of shares in LMC at a subscription consideration of RM1.50 million.
Related Party Transactions Other than compensation arrangements for our Directors and executive officers, which are described elsewhere in this annual report, the following includes a summary of transactions since January 1, 2023, and up through March 31, 2026, to which we were or are to be a participant, in which: ● the amount involved exceeded or will exceed the lesser of (1) U.S.$120,000 or (2) 1% of the average of our total assets; and ● any of our Directors, executive officers or holders of more than 5% of our Ordinary Shares, or member of the immediate family of, or person sharing the household with, the foregoing persons, had or will have a direct or indirect material interest.
Our code of business conduct and ethics as adopted has been incorporate by reference herewith as Exhibit 11.1 to this annual report. 133 In addition, our audit committee, pursuant to its written charter is responsible for reviewing and approving related party transactions to the extent that we enter into such transactions.
In addition, our audit committee, pursuant to its written charter is responsible for reviewing and approving related party transactions to the extent that we enter into such transactions.
(2) mDR Limited is a public listed company on the Mainboard of the SGX-ST. (3) Rounded to the nearest two decimal places. B.
Choo is deemed to beneficially own the 194,112 Ordinary Shares held by EP Capital, and (c) 318,324 Ordinary Shares held directly by Mr. Choo. (2) mDR Limited is a public listed company on the Mainboard of the SGX-ST. (3) Rounded to the nearest two decimal places. B.
The terms of these service agreements are substantially similar to each other. An NEO may terminate his employment at any time upon three-months prior written notice. We may immediately terminate in the event of default, misconduct or any breach or non-observance by the employee.
Such service agreements do not have a specified term and provide that such services agreements are terminable for cause at any time. The terms of these service agreements are substantially similar to each other. An executive officer may terminate his employment at any time upon three-months prior written notice.
TOH Keng Kiat - - YEW Chak Hua - - Mark LEONG Kei Wei - - LOH Yuin Han - - All directors and NEOs as a group (6 persons) 3,262,564 28.28 % (1) Consists of: (a) 2,075,310 ordinary shares held by Glorious Finance Limited (“Glorious Finance”). CHOO Chee Kong (“Mr. Choo”) owns 55.0% of shares in Glorious Finance. Mr.
Number of shares % (3) Shareholders with 5% or more Ordinary Shares in the Company: Glorious Finance Limited 3,773,291 31.90 % mDR Limited (2) 1,221,523 10.33 % WANG Shu 883,858 7.47 % Directors and Executive Officers: CHOO Chee Kong (1) 2,587,746 21.88 % ZENG Jieming 589,239 4.98 % TOH Keng Kiat 4,000 0.03 % YEW Chak Hua 2,469 0.02 % Mark LEONG Kei Wei - - % LOH Yuin Han 4,000 0.03 % Lucas LUK Tien Wee 103,813 0.88 % GOH Yvonne 25,781 0.22 % TAN Yoong Ying 25,781 0.22 % All Directors and Executive Officers as a group (9 persons) 3,342,829 28.26 % (1) Consists of: (a) 2,075,310 Ordinary Shares held by Glorious Finance Limited (“Glorious Finance”).
Removed
Compensation The table below sets forth information regarding the total compensation awarded to and earned by the Company’s NEOs for services rendered during the financial year ended December 31, 2024: Name and Principal Position Year Salary (1) U.S.$ Bonus U.S.$ All Other Compensation U.S.$ Total U.S.$ CHOO Chee Kong, 2024 37,923 220 - 38,143 Chairman (2) Dr.
Added
Compensation Compensation of Directors and Executive Officers For the financial year ended December 31, 2025, we paid an aggregate of S$660,833 to our Directors and executive officers as a group, comprising S$477,971 in cash compensation and S$182,862 in share-based compensation, representing 63,281 Ordinary Shares issued during the year.
Removed
ZENG Jieming, 2024 100,573 1,464 - 102,037 Chief Scientific and Medical Officer (2) Dr. TAN Wee Kiat, 2024 107,434 - - 107,434 Co-Chief Executive Officer and Chief Operating Officer (2)(3) (1) Inclusive of allowance and employer’s Central Provident Fund and Skills Development Levy.
Added
None of our Directors or executive officers receives pension, retirement or other similar benefits from us, and we have not set aside or accrued any amount to provide such benefits.
Removed
(2) The compensation reported above was paid in Singapore dollars and is reported above based on a rate of S$1.3662 to U.S.$1.00, the exchange rate in effect as of December 31, 2024, as set forth in the H.10 statistical release of the U.S. Board of Governors of the Federal Reserve System.
Added
As a company incorporated in Singapore, we are required by law to make contributions to the Central Provident Fund for all employees who are employed under a contract of service as prescribed under the Central Provident Fund Act 1953.
Removed
(3) Dr Tan resigned as Director, Co-Chief Executive Officer and Chief Operating Officer effective on December 31,2024. 125 Service Agreements with NEOs Effective April 18, 2023, we entered into service agreements with each of our NEOs. Such service agreements do not have a specified term and provide that such services agreements are terminable for cause at any time.
Added
The contribution rates vary, depending on the age of the employee, and whether such employee is a Singapore citizen or permanent resident. Service Agreements with Executive Officers Effective April 18, 2023, we entered into service agreements with each of our executive offices.
Removed
YEW Chak Hua, with Mark LEONG Kei Wei serving as chairperson.
Added
YEW Chak Hua, with Mark LEONG Kei Wei serving as chairperson. Our Board has determined that Mark LEONG Kei Wei is an “audit committee financial expert” as defined by applicable SEC rules and the Nasdaq Listing Rules and regulations.
Removed
Number of shares % (3) Shareholders with 5% or more ordinary shares in the Company: Glorious Finance Limited 3,773,291 32.70 % mDR Limited (2) 1,221,523 10.59 % WANG Shu 883,858 7.66 % 28 Consultants Limited 715,000 6.20 % ZENG Jieming 589,239 5.11 % Directors and NEOs: CHOO Chee Kong (1) 2,673,325 23.17 % ZENG Jieming 589,239 5.11 % Dr.
Added
Transactions with Landmark Medical Centre Sdn Bhd (“LMC”) On January 20, 2020, we entered into an investment agreement with, inter alia , LMC, as subsequently varied by a supplemental agreement dated January 20, 2021 and a further supplemental letter dated October 28, 2021, to acquire new ordinary shares representing 20.0% of the total number of shares in LMC at a subscription consideration of RM1.50 million.
Removed
Dr Lucas LUK Tien Wee is deeply involved in our preparation for clinical trial application in Singapore and Malaysia. As Chief Executive Officer and major shareholder of LMC, Dr Lucas LUK Tien Wee brings valuable expertise, experience and connections to facilitate clinical trial preparation including protocol documentation.
Added
The aggregate transaction amounts for the three-year period ended December 31, 2025 and as of the date of this annual report are as follows: 2023 2024 2025 From January 1, 2026 to the date of this annual report S$ S$ S$ S$ Research income from LMC 183,518 115,277 24,167 3,584 On December 18, 2025, we disposed of our entire 20.0% equity interest in LMC for a consideration of RM1.65 million.
Added
Transactions with EP Capital Inc. (“EP Capital”) EP Capital is a shareholder of the Company and is wholly owned by Mr. CHOO Chee Kong, our Chairman and Director. On October 4, 2024, EP Capital subscribed for 20,000 ordinary shares in our subsidiary, LongevityBank Pte Ltd, for a consideration of approximately S$46,565.
Added
On December 12, 2025, EP Capital further subscribed 40,000 ordinary shares for a consideration of S$200,000.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

10 edited+5 added−1 removed104 unchanged
Individual Income Tax An individual is a tax resident in Singapore in a year of assessment (“ YA ”) if, in the year preceding the YA, he was physically present in Singapore or exercised an employment in Singapore (other than as a director of a company) for 183 days or more, or if he resides in Singapore except for such temporary absences therefrom as may be reasonable and not inconsistent with a claim by such individual to be resident in Singapore. 135 Individual taxpayers who are Singapore tax residents are subject to Singapore income tax on income accruing in or derived from Singapore.
Individual Income Tax An individual is a tax resident in Singapore in a year of assessment (“ YA ”) if, in the year preceding the YA, he was physically present in Singapore or exercised an employment in Singapore (other than as a director of a company) for 183 days or more, or if he resides in Singapore except for such temporary absences therefrom as may be reasonable and not inconsistent with a claim by such individual to be resident in Singapore. 136 Individual taxpayers who are Singapore tax residents are subject to Singapore income tax on income accruing in or derived from Singapore.
The deductibility of capital losses is subject to limitations. 141 Passive Foreign Investment Company Rules In general, a non-U.S. corporation is a PFIC for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of the value of its assets (generally determined based on the average of the quarterly values of its gross assets) consists of assets that produce, or are held for the production of, passive income, or (ii) 75% or more of its gross income consists of passive income.
The deductibility of capital losses is subject to limitations. 142 Passive Foreign Investment Company Rules In general, a non-U.S. corporation is a PFIC for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of the value of its assets (generally determined based on the average of the quarterly values of its gross assets) consists of assets that produce, or are held for the production of, passive income, or (ii) 75% or more of its gross income consists of passive income.
Partnerships that intend to own ordinary shares and their partners should consult their tax advisers as to their particular U.S. federal income tax consequences of owning and disposing of ordinary shares. 140 This discussion is based on the Code, administrative pronouncements, judicial decisions, and final, temporary and proposed United States Treasury regulations, all as of the date hereof, any of which is subject to change, possibly with retroactive effect.
Partnerships that intend to own Ordinary Shares and their partners should consult their tax advisers as to their particular U.S. federal income tax consequences of owning and disposing of Ordinary Shares. 141 This discussion is based on the Code, administrative pronouncements, judicial decisions, and final, temporary and proposed United States Treasury regulations, all as of the date hereof, any of which is subject to change, possibly with retroactive effect.
Holders should consult their tax advisers regarding the determination of whether we are a PFIC for any taxable year and the potential application of the PFIC rules to their ownership of ordinary shares. 142 Information Reporting and Backup Withholding Payments of distributions and sales proceeds that are made within the United States or through certain U.S. related financial intermediaries may be subject to information reporting and backup withholding, unless (i) the U.S.
Holders should consult their tax advisers regarding the determination of whether we are a PFIC for any taxable year and the potential application of the PFIC rules to their ownership of Ordinary Shares. 143 Information Reporting and Backup Withholding Payments of distributions and sales proceeds that are made within the United States or through certain U.S. related financial intermediaries may be subject to information reporting and backup withholding, unless (i) the U.S.
In summary, the tax treatments for the income of a person in Malaysia are depicted as follows: Income Derived From Income Received In Prior to January 1, 2022 Effective from January 1, 2022 Malaysia Malaysia Taxable Taxable Malaysia Malaysia from outside Malaysia Taxable Taxable Overseas Malaysia from outside Malaysia Tax Exempted Taxable Overseas Overseas Tax Exempted Tax Exempted 139 On November 16, 2021, the IRB announced the Special Income Remittance Program (“SIRP”) for Malaysian tax residents whose income is derived from foreign sources and received in Malaysia.
In summary, the tax treatments for the income of a person in Malaysia are depicted as follows: Income Derived From Income Received In Prior to January 1, 2022 Effective from January 1, 2022 Malaysia Malaysia Taxable Taxable Malaysia Malaysia from outside Malaysia Taxable Taxable Overseas Malaysia from outside Malaysia Tax Exempted Taxable Overseas Overseas Tax Exempted Tax Exempted 140 On November 16, 2021, the IRB announced the Special Income Remittance Program (“SIRP”) for Malaysian tax residents whose income is derived from foreign sources and received in Malaysia.
Dividends received in respect of our ordinary shares by either a resident or non-resident of Singapore are not subject to Singapore withholding tax, on the basis that we are a tax resident of Singapore and under the one-tier system. 136 Under the one-tier system, the tax on corporate profits is final and dividends paid by a Singapore resident company are tax exempt in the hands of a shareholder, regardless of whether the shareholder is a company or an individual and whether or not the shareholder is a Singapore tax resident.
Dividends received in respect of our Ordinary Shares by either a resident or non-resident of Singapore are not subject to Singapore withholding tax, on the basis that we are a tax resident of Singapore and under the one-tier system. 137 Under the one-tier system, the tax on corporate profits is final and dividends paid by a Singapore resident company are tax exempt in the hands of a shareholder, regardless of whether the shareholder is a company or an individual and whether or not the shareholder is a Singapore tax resident.
Estate Duty Singapore estate duty was abolished with respect to all deaths occurring on or after February 15, 2008. 137 GST The sale of our ordinary shares by a GST-registered investor belonging in Singapore for GST purposes to another person belonging in Singapore is an exempt supply not subject to GST.
Estate Duty Singapore estate duty was abolished with respect to all deaths occurring on or after February 15, 2008. 138 GST The sale of our Ordinary Shares by a GST-registered investor belonging in Singapore for GST purposes to another person belonging in Singapore is an exempt supply not subject to GST.
Currently, a Singapore tax resident individual is taxed at progressive rates ranging from 0% to 22%. The maximum tax rate will be increased to 24% with effect from the year of assessment 2024.
Currently, a Singapore tax resident individual is taxed at progressive rates ranging from 0% to 22%. The maximum tax rate will be increased to 24% with effect from the YA 2024.
The corporate income tax rates are as illustrated below: Types of Company Chargeable income Tax rate YA 2024 Resident company: ● with paid-up capital of 2.5 million Malaysian ringgit (RM) or less, and gross income from business of not more than RM50 million On the first RM150,000 15% ● that does not control, directly or indirectly, another company that has paid-up capital of more than RM2.5 million RM150,001 to RM600,000 17% ● is not controlled, directly or indirectly, by another company that has paid-up capital of more than RM2.5 million, and RM600,001 and Subsequent Balance 24% ● with no more than 20% of its paid-up capital being owned, directly or indirectly, by a foreign company or non-Malaysian citizen Company other than the above category 24% 138 The Budget Speech 2024 highlighted the Malaysian government’s commitment in encouraging Micro, Small and Medium Enterprises (“MSMEs”) to digitalize their operations and adopt automation, with the ultimate goal of becoming a sustainable business.
The corporate income tax rates are as illustrated below: Types of Company Chargeable income Tax rate YA 2025 Resident company: ● with paid-up capital of 2.5 million Malaysian ringgit (RM) or less, and gross income from business of not more than RM50 million On the first RM150,000 15% ● that does not control, directly or indirectly, another company that has paid-up capital of more than RM2.5 million RM150,001 to RM600,000 17% ● is not controlled, directly or indirectly, by another company that has paid-up capital of more than RM2.5 million, and RM600,001 and Subsequent Balance 24% ● with no more than 20% of its paid-up capital being owned, directly or indirectly, by a foreign company or non-Malaysian citizen Company other than the above category 24% 139 The implementation of e-invoicing is dependent on the annual turnover or revenue of a taxpayer as illustrated below: Taxpayers Implementation Date Taxpayers with an annual turnover or revenue of more than RM100 million 1 August 2024 Taxpayers with an annual turnover or revenue of more than RM25 million and up to RM100 million 1 January 2025 Taxpayers with an annual turnover or revenue of more than RM5 million and up to RM25 million 1 July 2025 Taxpayers with an annual turnover or revenue of up to RM5 million 1 January 2027 Further, there is a proposed tax deduction of up to RM50,000 for each YA, effective from YA 2024 to YA 2027.
The remaining chargeable income (after the tax exemption) will be taxed at the applicable corporate tax rate. Dividend Distributions All Singapore-resident companies are currently under the one-tier system.
The remaining chargeable income (after the tax exemption) will be taxed at the applicable corporate tax rate. For YA 2025, a corporate income tax rebate of 50% of the corporate income tax payable (the “CIT Rebate”) will be granted to all taxpaying companies, regardless of tax residency status.
Removed
For taxpayers with an annual income or sales exceeding RM100 million, e-invoicing implementation is mandated from August 1, 2024. Taxpayers in other income categories are required to implement e-invoicing from July 1, 2025. Further, there is a proposed tax deduction of up to RM50,000 for each YA, effective from YA 2024 to YA 2027.
Added
In addition, active companies that have employed at least one local employee in calendar year 2024 (the “Local Employee Condition”) will receive a minimum benefit of S$2,000 in the form of a CIT rebate cash grant (the “CIT Rebate Cash Grant”).
Added
The CIT Rebate is capped at S$40,000 per company, or S$38,000 for companies that receive (or are eligible to receive) the CIT Rebate Cash Grant. To be eligible for the CIT Rebate Cash Grant, a company must (i) be an active company and (ii) have satisfied the Local Employee Condition.
Added
An “active company” refers to a company that is carrying on a trade or business at the time of disbursement of the CIT Rebate Cash Grant.
Added
A company is regarded as having satisfied the Local Employee Condition if it made Central Provident Fund (“CPF”) contributions in respect of at least one local employee (being a Singapore citizen or permanent resident), excluding shareholders who are also directors of the company, during calendar year 2024.
Added
Eligible active companies, whether tax resident or not, that have satisfied the Local Employee Condition will automatically receive the CIT Rebate Cash Grant by the second quarter of 2025. The CIT Rebate Cash Grant will not be taxable. Dividend Distributions All Singapore-resident companies are currently under the one-tier system.