SINGAPORE, Aug. 28, 2025 (GLOBE NEWSWIRE) -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumours, is pleased to announce it has successfully expanded clinical-scale natural killer (“NK”) cells from cord blood units that have been ...

Core Viewpoint - CytoMed Therapeutics Limited has entered into an At-the-Market Sales Agreement to raise up to $4,304,945 through the sale of ordinary shares, which will be used for general corporate purposes and potential acquisitions [1][2][3] Group 1: Company Overview - CytoMed Therapeutics Limited is a clinical stage biopharmaceutical company based in Singapore, focused on developing novel donor blood-derived, cell-based allogeneic therapies for treating blood and solid cancers [1][4] - The company was incorporated in 2018 and spun off from Singapore's Agency for Science, Technology and Research (A*STAR) [4] - CytoMed utilizes proprietary technologies, including gamma delta T cells and iPSC-derived gamma delta Natural Killer T cells, to create immunotherapies inspired by the success of CAR-T therapies [4] Group 2: Financial Activities - The company has entered into a Sales Agreement with R.F. Lafferty & Co., Inc. to sell shares at its discretion based on market conditions and capital requirements [2] - Proceeds from the ATM program will be allocated for general corporate purposes, including business diversification, development initiatives, and capital expenditures [3] - The company has seen approximately 2,500 new customer sign-ups for its newly acquired cord blood bank since August 2024, contributing to revenue in 2025 [3]

Core Insights - CytoMed Therapeutics Limited has successfully completed dose level 1 of its first-in-human Phase I dose-escalation clinical trial (ANGELICA Trial) for late-stage cancer patients and plans to start dose level 2 in Q3 2025 [1][2] - The ANGELICA Trial is focused on evaluating the safety and tolerability of allogeneic NKG2DL-targeting CAR gamma delta T cells (CTM-N2D) for various cancer indications, including advanced solid and hematological malignancies [2] - CTM-N2D utilizes gamma delta T cells from healthy donors, which can be infused into patients without the need for donor-patient compatibility matching, differentiating it from conventional CAR-αβ T cell therapies [3][4] Company Overview - CytoMed was incorporated in 2018 and spun off from Singapore's Agency for Science, Technology and Research (A*STAR), focusing on developing novel cell-based allogeneic immunotherapies for cancer treatment [5] - The company aims to address the clinical limitations and commercial challenges of existing CAR-T therapies, particularly in treating solid tumors [5]

[Full Year 2024 Financial Results and Corporate Updates](index=1&type=section&id=CytoMed%20Therapeutics%20Reports%20Full%20Year%20Ended%20December%2031%2C%202024%20Financial%20Results%20and%20Provides%20Clinical%20and%20Corporate%20Updates) [Financial Results](index=1&type=section&id=Financial%20Results%20for%20the%20full-year%20ended%20December%2031%2C%202024) For FY2024, CytoMed reported a 39% reduction in net loss to $1.85 million due to lower IPO-related expenses, with topline income increasing to $624,771, research expenses rising to $1.40 million, and cash balances at $3.64 million deemed sufficient through 2026 Key Financial Highlights (FY 2024 vs. FY 2023) | Financial Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Topline Income | US$624,771 | US$588,423 | +6.2% | | Net Loss | US$1.85 million | US$3.03 million | -39% | | Research Expenses | US$1.40 million | US$1.16 million | +20.7% | | Other Expenses | US$730,532 | US$1.62 million | -54.9% | | Cash and Bank Balances | US$3.64 million | US$6.58 million | -44.7% | - The **significant reduction in net loss** was primarily due to the absence of initial public offering (IPO) related expenses, as well as lower company insurance and investor relations costs[4](index=4&type=chunk)[8](index=8&type=chunk) - The company believes its existing cash and bank balances of **US$3.64 million** will be sufficient to fund operations **through at least 2026**[5](index=5&type=chunk) - The **increase in research expenses** was mainly attributable to higher clinical trial expenses and increased employee benefits[6](index=6&type=chunk) [Clinical Updates](index=2&type=section&id=Clinical%20Updates) CytoMed has advanced its clinical pipeline, becoming a clinical-stage company by dosing the first patient in its Phase I ANGELICA trial in Singapore for its allogeneic gamma delta T cells, while also preparing for a Phase II trial in India, exploring opportunities in Malaysia, and advancing preclinical work with MD Anderson in the US for an eventual FDA IND submission - Became a **clinical-stage company** with the **first patient dosed** in the **Phase I ANGELICA trial** in Singapore in **November 2024**, marking a first-in-human trial using the company's patented donor-derived allogeneic gamma delta T cells[9](index=9&type=chunk) - An Indian partner received approval for a **Phase II Investigator Initiated Trial (IIT)**, with patient recruitment anticipated to commence in the **second half of 2025**[10](index=10&type=chunk) - US research collaborator, **MD Anderson**, has reported encouraging **in-vivo animal data** for Acute Myeloid Leukemia, with the goal of submitting an **Investigational New Drug (IND) application** to the **U.S. FDA**[12](index=12&type=chunk) - Finalizing the dossier for a **Phase I clinical trial** using umbilical cord-derived stem cells to treat osteoarthritis, with submission targeted for the **second half of 2025**[14](index=14&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) The company is actively expanding its strategic footprint, exploring a joint venture in China for low-cost cell manufacturing and focusing on China and India as key markets, with a significant corporate development being the acquisition of a licensed cord blood bank in Malaysia in August 2024, which will supply raw materials for new therapeutic programs and is planned for a future spin-off - Exploring a **joint venture in China** to establish **low-cost cell manufacturing capabilities**, with **China and India** being strategic focus markets[15](index=15&type=chunk) - On **August 15, 2024**, the company completed the **acquisition of a licensed cord blood bank in Malaysia**, one of only three in the country[16](index=16&type=chunk) - The acquired cord blood bank will provide **cost-free raw materials** for strategic expansion into **cord blood-derived therapeutics** for auto-immune diseases and cancers[16](index=16&type=chunk) - The company intends to **spin off this cord blood subsidiary** in the future as a separate biopharmaceutical company[16](index=16&type=chunk) [Strategies for Growth](index=3&type=section&id=Strategies%20for%20Growth) For 2025, CytoMed's growth strategy focuses on achieving key clinical milestones, including the initial readout from the ANGELICA trial and submitting a U.S. FDA IND application, while also enhancing its U.S. presence by opening a liaison office in New York and pursuing new revenue streams through compassionate use programs and partnerships - An important **2025 milestone** is the **initial clinical readout of the ANGELICA trial**, anticipated by the **end of the year**[17](index=17&type=chunk) - Plans to submit a **U.S. FDA IND application** for its donor-derived allogeneic gamma delta T cells for a common form of leukemia[17](index=17&type=chunk) - Intends to establish a **liaison office in New York** to enhance its U.S. profile, be closer to investors, and seek **M&A or strategic alliance opportunities**[17](index=17&type=chunk) - Plans to implement **alternative revenue-generating methods in 2025**, such as **compassionate use programs** for no-option late-stage patients[18](index=18&type=chunk) - While having a **cash runway into 2026**, the company plans to **strengthen its financials in 2025** to capitalize on new opportunities, including **M&A**[19](index=19&type=chunk)

[PART I](index=15&type=section&id=PART%20I) [ITEM 3. KEY INFORMATION](index=15&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section details the significant financial, business, manufacturing, and intellectual property risks facing the company [Risk Factors](index=15&type=section&id=D.%20Risk%20Factors) The company faces substantial risks from its limited operating history, unproven products, and reliance on licensed IP - The company is a clinical-stage biopharmaceutical firm with **no products approved for commercial sale** and has a limited operating history since its incorporation in 2018[35](index=35&type=chunk) Accumulated Losses (2022-2024) | Fiscal Year End | Accumulated Losses (S$) | | :--- | :--- | | Dec 31, 2022 | S$8.20 million | | Dec 31, 2023 | S$12.33 million | | Dec 31, 2024 | S$14.85 million | - The success of the business is highly dependent on its four main product candidates: **CTM-N2D, iPSC-gdNKT, CTM-GDT, and CTM-MSC**, none of which are guaranteed to receive regulatory approval or be successfully commercialized[51](index=51&type=chunk)[64](index=64&type=chunk) - The company relies heavily on **intellectual property licensed from third parties**, particularly ATPL (a subsidiary of A*STAR), and termination of these licenses could halt product development[142](index=142&type=chunk)[171](index=171&type=chunk) - As a Singapore-incorporated and **"controlled company"** under Nasdaq rules, shareholders may face difficulty protecting their interests and the company is exempt from certain governance requirements[269](index=269&type=chunk)[299](index=299&type=chunk) [ITEM 4. INFORMATION ON THE COMPANY](index=73&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) This section provides an overview of the company's history, business strategy, product pipeline, and assets [History and Development of the Company](index=73&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) The company was incorporated in Singapore in 2018 and executed a reverse stock split before its 2023 public listing - The company was incorporated in Singapore on March 9, 2018, and conducts its main business activities through its Malaysian subsidiaries, CytoMed Malaysia and IPSC Depository[331](index=331&type=chunk)[332](index=332&type=chunk) - A **1-for-380.83 reverse stock split** was effected on January 17, 2023, prior to its public listing[333](index=333&type=chunk) [Business Overview](index=74&type=section&id=B.%20Business%20Overview) The company is a clinical-stage biopharmaceutical firm developing "off-the-shelf" allogeneic cell-based immunotherapies - The company focuses on developing **"off-the-shelf" allogeneic cell therapies** to address the limitations of personalized, patient-specific (autologous) CAR-T treatments[338](index=338&type=chunk)[351](index=351&type=chunk) Product Pipeline Status | Product Candidate | Indication | Stage of Development | | :--- | :--- | :--- | | **CTM-N2D** | Relapsed/Refractory Solid Tumors | Phase I Clinical Trial (ANGELICA) | | **iPSC-gdNKT** | Relapsed/Refractory Solid Tumors | Preclinical Process Development | | **CTM-GDT** | Relapsed/Refractory Solid Tumors | Preclinical / IND Application planned | | **CTM-MSC** | Cartilage Injuries | Preclinical / Phase I planned | - The lead product, **CTM-N2D**, is being evaluated in the ANGELICA Phase I trial in Singapore, with two patients successfully dosed as of the report date[340](index=340&type=chunk)[377](index=377&type=chunk) - The company operates its own **cGMP facility in Johor, Malaysia**, which supports the manufacturing of cell therapy products for clinical trials and has been audited by the NPRA[349](index=349&type=chunk)[357](index=357&type=chunk) - In late 2024, the company acquired assets of a Malaysian cord blood bank, including a license, cryopreservation equipment with over **12,000 cord blood units**, and real estate[347](index=347&type=chunk) [Organizational Structure](index=141&type=section&id=C.%20Organizational%20Structure) The company is a Singapore-based holding company with its primary business activities conducted through Malaysian subsidiaries - The company is a holding company incorporated in Singapore, with its main operations conducted through its Malaysian subsidiaries, **CytoMed Malaysia and IPSC Depository**[664](index=664&type=chunk) [Property, Plants and Equipment](index=141&type=section&id=D.%20Property%2C%20Plants%20and%20Equipment) Key properties include a Singapore research lab, a Malaysian cGMP facility, and a newly acquired cord blood bank - The company owns a leasehold interest in its Singapore office and research lab, which expires in **2038**[473](index=473&type=chunk) - It owns a freehold, three-story **cGMP facility in Johor, Malaysia**, with approximately 8,600 square feet of gross floor area[480](index=480&type=chunk)[482](index=482&type=chunk) - Through a subsidiary, the company acquired two freehold properties in Malaysia housing a **cord blood bank facility** in late 2024[485](index=485&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=141&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) Management analyzes the company's financial condition, operating results, and liquidity for fiscal years 2022-2024 [Operating Results](index=141&type=section&id=A.%20Operating%20Results) The company recorded its first revenue in 2024 but continues to incur net losses driven by R&D expenses - The company generated its first revenue of **S$69,501 in FY 2024**, derived from its newly acquired private blood banking services[677](index=677&type=chunk) Key Financial Results (S$) | Metric | 2022 | 2023 | 2024 | | :--- | :--- | :--- | :--- | | **Revenue** | - | - | 69,501 | | **Research Expenses** | (1,522,765) | (1,589,693) | (1,909,519) | | **Other Expenses** | (494,675) | (2,213,142) | (998,054) | | **Loss for the year** | (3,131,452) | (4,133,170) | (2,521,861) | - Research expenses increased by S$319,826 in 2024, primarily due to a **S$348,169 increase in clinical trial expenses** for the ANGELICA Trial[685](index=685&type=chunk) - Other expenses decreased by S$1.22 million in 2024, mainly because of the absence of **S$758,563 in IPO-related expenses** that were incurred in 2023[691](index=691&type=chunk) [Liquidity and Capital Resources](index=148&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) Operations are funded by private equity and IPO proceeds, with future financing needed as clinical programs advance Cash and Cash Equivalents (S$) | As of | Cash and Bank Balances | | :--- | :--- | | Dec 31, 2023 | S$9.00 million | | Dec 31, 2024 | S$4.97 million | Summary of Cash Flows (S$) | Cash Flow Activity | 2022 | 2023 | 2024 | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | (1,398,409) | (3,531,196) | (2,709,929) | | **Net cash (used in)/from investing activities** | (473,305) | (2,730,809) | 1,126,541 | | **Net cash from/(used in) financing activities** | 968,716 | 10,919,885 | (64,892) | - The company received net proceeds of **S$10.31 million** from its Initial Public Offering in April 2023[672](index=672&type=chunk) [Directors, Senior Management and Employees](index=153&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section provides information on the company's leadership team, compensation practices, and employee base [Directors and Senior Management](index=153&type=section&id=A.%20Directors%20and%20Senior%20Management) The leadership includes a six-member Board with four independent directors and a five-person senior management team - The Board of Directors consists of 6 members: Chairman CHOO Chee Kong, Dr. ZENG Jieming, and four independent directors (Prof. LOH Yuin Han, Dr. YEW Chak Hua, Mark LEONG Kei Wei, Dr. TOH Keng Kiat)[732](index=732&type=chunk)[759](index=759&type=chunk) - The executive management team includes CHOO Chee Kong (Chairman), Dr. ZENG Jieming (CSO & Medical Officer), Dr. Lucas LUK Tien Wee (Chief Clinical Officer), GOH Yvonne (CFO), and TAN Yoong Ying (Chief Corporate Officer)[736](index=736&type=chunk) [Compensation](index=158&type=section&id=B.%20Compensation) This subsection details compensation for Named Executive Officers and non-employee directors for fiscal year 2024 2024 Named Executive Officer Compensation | Name and Principal Position | Total Compensation (U.S.$) | | :--- | :--- | | CHOO Chee Kong, Chairman | 38,143 | | Dr. ZENG Jieming, Chief Scientific and Medical Officer | 102,037 | | Dr. TAN Wee Kiat, Co-CEO and COO (resigned Dec 31, 2024) | 107,434 | - Non-employee directors receive annual cash retainers for their service on the board (**U.S.$12,000**) and its committees, with additional retainers for chairpersons[757](index=757&type=chunk) - The company adopted an **Executive Compensation Recovery (Clawback) Policy** on November 16, 2023, as required by Nasdaq listing standards[758](index=758&type=chunk) [Board Practices](index=160&type=section&id=C.%20Board%20Practices) The Board has four independent directors and three key committees: Audit, Compensation, and Nominating/Governance - The Board has three key committees: **Audit, Compensation, and Nominating and Corporate Governance**, all established on April 18, 2023[759](index=759&type=chunk) - The Audit Committee is chaired by Mark LEONG Kei Wei, who is designated as the **"audit committee financial expert"**[760](index=760&type=chunk) [Employees](index=162&type=section&id=D.%20Employees) As of the report date, the company has 43 full-time employees and maintains an equity incentive plan - The company has **43 full-time employees**, with 28 dedicated to R&D and manufacturing[771](index=771&type=chunk) - The 2023 Equity Incentive Plan reserves **1,279,117 ordinary shares** for awards such as share options and restricted shares to employees, directors, and consultants[775](index=775&type=chunk)[776](index=776&type=chunk) [Major Shareholders and Related Party Transactions](index=165&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section discloses the company's ownership structure and details material transactions with related entities [Major Shareholders](index=165&type=section&id=A.%20Major%20Shareholders) Ownership is concentrated, with Glorious Finance Limited holding 32.70% and directors/NEOs holding 28.28% as a group Major Shareholders (5% or more) | Shareholder | Ownership Percentage | | :--- | :--- | | Glorious Finance Limited | 32.70% | | mDR Limited | 10.59% | | WANG Shu | 7.66% | | 28 Consultants Limited | 6.20% | | ZENG Jieming | 5.11% | - All directors and NEOs as a group beneficially own **28.28%** of the company's ordinary shares[794](index=794&type=chunk) [Related Party Transactions](index=166&type=section&id=B.%20Related%20Party%20Transactions) The company engaged in transactions with its 20%-owned associate, Landmark Medical Centre Sdn Bhd (LMC) - The company holds a **20% equity stake** in Landmark Medical Centre Sdn Bhd (LMC), a private hospital in Malaysia[797](index=797&type=chunk) Research Income from LMC (S$) | Year | Research Income | | :--- | :--- | | 2022 | 207,206 | | 2023 | 183,518 | | 2024 | 115,277 | [Financial Information](index=168&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section confirms no significant legal proceedings and outlines the company's policy of retaining earnings for expansion - The company has not been subject to any **significant legal or arbitration proceedings**[806](index=806&type=chunk) - The company **does not anticipate paying dividends** in the near future, intending to retain any earnings for business expansion[810](index=810&type=chunk) [Additional Information](index=170&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) This section provides supplementary corporate details, including material tax considerations for investors [Taxation](index=170&type=section&id=E.%20Taxation) This subsection details material tax considerations in Singapore, Malaysia, and the U.S., including PFIC risks - Singapore Tax: Dividends paid by the company are **tax-exempt** to shareholders under the one-tier system and Singapore does not impose tax on capital gains[831](index=831&type=chunk)[833](index=833&type=chunk)[834](index=834&type=chunk) - Malaysia Tax: Malaysia operates on a territorial tax principle and **dividends distributed by Malaysian companies are exempt** from tax in the hands of shareholders[847](index=847&type=chunk)[858](index=858&type=chunk) - U.S. Federal Income Tax: The company does not expect to be a Passive Foreign Investment Company (PFIC), but its status is an annual determination and **PFIC classification would result in adverse tax treatment** for U.S. Holders[870](index=870&type=chunk) [PART II](index=180&type=section&id=PART%20II) [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=180&type=section&id=ITEM%2014.%20MATERIAL%20MODIFICATIONS%20TO%20THE%20RIGHTS%20OF%20SECURITY%20HOLDERS%20AND%20USE%20OF%20PROCEEDS) This section confirms no changes to shareholder rights and updates the use of IPO proceeds [Use of Proceeds](index=180&type=section&id=E.%20Use%20of%20Proceeds) The company raised S$10.31 million in net IPO proceeds in April 2023 with no material change in their planned use - The company raised approximately **S$10.31 million in net proceeds** from its IPO, which was completed on April 18, 2023[891](index=891&type=chunk) - As of December 31, 2024, the company confirms **no material change in the use of proceeds** from its registration statement[892](index=892&type=chunk) [Controls and Procedures](index=180&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective as of December 31, 2024 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2024[893](index=893&type=chunk) - As a newly public company, the annual report does not yet include a management assessment or auditor attestation on internal control over financial reporting, per SEC transition rules[896](index=896&type=chunk)[897](index=897&type=chunk) [Corporate Governance and Other Disclosures](index=182&type=section&id=ITEM%2016.%20CORPORATE%20GOVERNANCE%20AND%20OTHER%20DISCLOSURES) This section details corporate governance matters, including committee experts, accountant fees, and cybersecurity risks - The board has determined that **Mark LEONG Kei Wei is an "Audit Committee Financial Expert"**[900](index=900&type=chunk) Principal Accountant Fees (WWC, P.C.) | Fee Type | 2022 (U.S.$) | 2023 (U.S.$) | 2024 (U.S.$) | | :--- | :--- | :--- | :--- | | Audit Fees | 70,000 | 85,000 | 95,000 | | Audit-Related Fees | 18,000 | 20,000 | 20,000 | - As a **foreign private issuer**, the company follows Singaporean corporate governance practices, opting out of certain Nasdaq rules[909](index=909&type=chunk) - The company has implemented protocols to manage cybersecurity risks, overseen by the Chief Corporate Officer, Ms. TAN Yoong Ying, who reports to the board[919](index=919&type=chunk)[921](index=921&type=chunk) [PART III](index=185&type=section&id=PART%20III) [Financial Statements](index=185&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) This section contains the company's audited consolidated financial statements for fiscal years 2022, 2023, and 2024 Consolidated Statement of Financial Position (S$) | As of December 31 | 2023 | 2024 | | :--- | :--- | :--- | | **Total Assets** | 12,368,870 | 10,067,749 | | **Total Liabilities** | 1,124,715 | 1,023,960 | | **Total Equity** | 11,244,155 | 9,043,789 | Consolidated Statement of Profit or Loss (S$) | For the Year Ended December 31 | 2022 | 2023 | 2024 | | :--- | :--- | :--- | :--- | | **Revenue** | - | - | 69,501 | | **Loss for the year** | (3,131,452) | (4,133,170) | (2,521,861) | | **Total comprehensive loss for the year** | (3,227,956) | (4,223,088) | (2,358,216) |

Core Insights - CytoMed Therapeutics Limited is focused on developing affordable donor-derived, cell-based allogeneic immunotherapies, targeting the ASEAN region and North Asia with a population exceeding two billion [2][22] - The company reported a reduced net loss of US$1.85 million for the year ended December 31, 2024, a 39% improvement from US$3.03 million in 2023, primarily due to lower operational costs [4][3] - CytoMed is advancing its clinical trials, including the ANGELICA trial, which is the first-in-human CAR T trial using donor-derived gamma delta T cells [9][10] Financial Performance - Topline income for 2024 was US$624,771, an increase from US$588,423 in 2023 [3] - Cash and bank balances decreased to US$3.64 million as of December 31, 2024, down from US$6.58 million in 2023, but are expected to fund operations through at least 2026 [5] - Research expenses rose to US$1.40 million in 2024 from US$1.16 million in 2023, driven by higher clinical trial costs [6] Clinical Developments - The ANGELICA trial, approved in Singapore, began dosing patients in November 2024, focusing on the use of gamma delta T cells for various cancers [9][10] - A Phase II Investigator Initiated Trial in India is set to commence patient recruitment in the second half of 2025, utilizing CytoMed's manufactured cells [11] - The company is also developing iPSC-derived hybrid immune cells for cancer treatment and has received trial approvals for other conditions [14] Corporate Strategy - CytoMed is exploring a joint venture in China to enhance low-cost cell manufacturing and expand its market reach [16] - The acquisition of a licensed cord blood bank in Malaysia aims to support the development of cord blood-derived therapeutics for autoimmune diseases and cancers [17] - The company plans to establish a liaison office in New York to strengthen its presence in the U.S. market and explore strategic partnerships [19] Future Outlook - An important milestone for 2025 includes the initial clinical readout of the ANGELICA trial and the submission of a U.S. FDA IND application for gamma delta T cells [18] - The company aims to implement alternative revenue-generating methods to assist late-stage patients and capitalize on the growing medical tourism market in Asia [20] - Financial prudence is emphasized, with plans to strengthen financials and prepare for potential mergers and acquisitions in 2025 [21]

Core Insights - CytoMed Therapeutics Limited is focusing on the development of affordable GMP-grade immune cells for patients with cancer and autoimmune diseases, leveraging Asia's low-cost infrastructure and talent [3][4] - The company has achieved significant milestones in 2024, including becoming a clinical stage biopharma and initiating the ANGELICA trial, which is the first-in-human CAR T trial using donor-derived allogeneic gamma delta T cells [4][10] - CytoMed has made strategic acquisitions and partnerships to expand its capabilities and market reach, including the acquisition of a licensed cord blood bank and collaborations in China and India [5][6] Company Developments - The ANGELICA trial commenced in November 2024, with a focus on late-stage cancer patients, supported by a grant from the National Medical Research Council of Singapore [4] - The acquisition of a cord blood bank for approximately US$ 450,000 aims to facilitate the development of cord blood-derived therapeutics, particularly for autoimmune diseases [5] - The company is establishing a presence in New York to enhance its profile in the US market and explore opportunities for mergers and acquisitions [10] Strategic Direction - CytoMed plans to implement revenue-generating methods for late-stage patients, including partnerships with clinics and hospitals in Asia [11] - The company is working towards submitting a US FDA IND for its allogeneic gamma delta T cells and aims for initial clinical readouts from the ANGELICA trial by mid-2025 [10] - The focus on international medical tourism in Asia presents opportunities for developing cell therapies that are often expensive or inaccessible in Western markets [11]

Core Insights - CytoMed Therapeutics Limited is focusing on the development of affordable GMP-grade immune cells for patients with cancer and autoimmune diseases, leveraging Asia's low-cost infrastructure and talent [3][4] - The company has transitioned to a clinical stage biopharma with the initiation of the ANGELICA trial, which is the first-in-human CAR T trial using donor-derived allogeneic gamma delta T cells [4][10] - CytoMed has made strategic acquisitions and partnerships to enhance its capabilities and expand into new markets, including the acquisition of a licensed cord blood bank and collaborations in China and India [5][6] Company Developments - The ANGELICA trial commenced in November 2024, with a small patient recruitment target of no more than 20 late-stage cancer patients, supported by a significant grant from the National Medical Research Council of Singapore [4] - The acquisition of a cord blood bank for approximately US$ 450,000 aims to provide raw materials for new cord blood-derived therapeutics, with plans to spin off this subsidiary in the future [5] - CytoMed is establishing a presence in New York to enhance its profile in the US market and explore opportunities for mergers and acquisitions [10] Strategic Direction - The company plans to implement revenue-generating methods for late-stage patients on a compassionate basis, including investments in clinics and partnerships with hospitals [11] - CytoMed is working towards submitting a US FDA IND for its allogeneic gamma delta T cells and aims for initial clinical readout of the ANGELICA trial by mid-2025 [10] - The company is also involved in an international AI project to utilize its gamma delta T cells for treating infectious diseases in developing countries [9]

Core Insights - CytoMed Therapeutics Limited has acquired the license and certain assets of Cellsafe International Sdn Bhd for approximately RM 2.3 million (US$ 490,000), aiming to enhance its capabilities in developing γδ T cell therapies for cancer treatment [4][21] - The company has received a patent for its iPSC-derived hybrid γδ NKT cells technology, which targets both solid and hematological cancers, expanding its intellectual property portfolio [1][9][18] - CytoMed plans to leverage umbilical cord blood as a valuable resource for producing immune T cells, thereby enhancing the therapeutic potential of cord blood banking [2][14][22] Company Developments - The acquisition includes a cord blood banking license, cryopreservation equipment with over 12,000 cord blood units (CBUs), and two real estate properties [13] - CytoMed aims to be a leading player in γδ T cell technology, focusing on producing clinically relevant numbers of GMP-grade γδ T cells from various sources, including adult peripheral blood and iPSCs [14][19] - The company is conducting the ANGELICA Trial, a phase 1 clinical trial in Singapore, focusing on CAR-T therapies [6][7] Technology and Innovation - γδ T cells, which account for 1% to 5% of body T cells, possess innate tumor recognition capabilities and robust cytotoxic activity against various cancer types [5] - The newly granted patent allows for the generation of hybrid γδ NKT cells without gene editing, providing a platform for potential gene editing in the future [9][18] - CytoMed's proprietary technologies are inspired by the clinical success of existing CAR-T therapies, aiming to address limitations in treating solid tumors [19] Strategic Vision - The company intends to seek strategic partners to develop and grow its subsidiary as a specialized umbilical cord blood-derived immune cell bank [21] - CytoMed's management has shown commitment by obtaining board approval to invest up to a 7% stake in the venture, reflecting confidence in the growth potential [8] - The company is positioned to repurpose cryopreserved assets from cord blood banks, changing the traditional business model of cord blood banking [15][22]

PART I [ITEM 3. KEY INFORMATION](index=15&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section details significant investment risks, encompassing financial position, business operations, manufacturing, intellectual property, commercialization, and share ownership [Risk Factors](index=15&type=section&id=D.%20Risk%20Factors) The company faces extensive risks including financial losses, product development dependency, manufacturing complexities, intellectual property reliance, commercialization challenges, and concentrated share ownership - The company is a pre-clinical stage entity with no approved products and a limited operating history since 2018[38](index=38&type=chunk) - Business success is highly dependent on four unapproved product candidates: CTM-N2D, iPSC-gdNKT, CTM-GDT, and CTM-MSC[54](index=54&type=chunk)[66](index=66&type=chunk) - The company heavily relies on three key technology licenses from Accelerate Technologies Pte. Ltd. (ATPL), whose termination would severely impact core product development[165](index=165&type=chunk) - Principal shareholders, officers, and directors beneficially own approximately **70.80%** of outstanding ordinary shares, granting significant control over shareholder matters[238](index=238&type=chunk) Accumulated Losses (S$) | Date | Accumulated Losses (S$) | | :--- | :--- | | Dec 31, 2021 | S$5.07 million | | Dec 31, 2022 | S$8.20 million | | Dec 31, 2023 | S$12.33 million | [ITEM 4. INFORMATION ON THE COMPANY](index=67&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) This section provides a comprehensive overview of CytoMed Therapeutics, covering its history, business operations, organizational structure, and properties [History and Development of the Company](index=67&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) CytoMed Therapeutics Limited, incorporated in Singapore in 2018, operates as a holding company with its main business through its Malaysian subsidiary - The company was incorporated in Singapore on March 9, 2018, converting to a public limited company on January 19, 2023[304](index=304&type=chunk) - A **1-for-380.83** reverse split of its ordinary shares became effective on January 17, 2023[306](index=306&type=chunk) [Business Overview](index=68&type=section&id=B.%20Business%20Overview) CytoMed develops 'off-the-shelf' cell-based immunotherapies using proprietary platforms, with its lead candidate CTM-N2D entering Phase I clinical trials - The company develops 'off-the-shelf' cell-based immunotherapies using healthy donor blood cells and induced pluripotent stem cell (iPSC) technologies[310](index=310&type=chunk)[311](index=311&type=chunk) - The lead product, CTM-N2D, is being evaluated in the ANGELICA Trial, a Phase I study assessing its safety in human subjects[311](index=311&type=chunk)[312](index=312&type=chunk) - The company operates its own cGMP facility in Johor, Malaysia, capable of manufacturing products for Phase I and II clinical trials after NPRA audit[319](index=319&type=chunk)[328](index=328&type=chunk) Product Pipeline and Development Stage | PRODUCT CANDIDATE | INDICATION | STAGE OF DEVELOPMENT | NEXT ANTICIPATED MILESTONES | | :--- | :--- | :--- | :--- | | **CTM-N2D** | R/R SOLID TUMORS | PHASE I | Patient Recruitment 2Q 2024 | | **iPSC-gdNKT** | R/R SOLID TUMORS | DISCOVERY & PROCESS DEVELOPMENT | Preclinical Studies After 2024 | | **CTM-GDT** | R/R SOLID TUMORS | PRECLINICAL STUDIES & TRIAL APPLICATION | IND/CTX Application After 2023 | | **CTM-MSC** | Cartilage Injury | PRECLINICAL STUDIES | Preclinical Studies in Progress | [Organizational Structure](index=128&type=section&id=C.%20Organizational%20Structure) The company is a Singapore-based holding company, conducting primary business operations through its wholly-owned Malaysian subsidiary - CytoMed Therapeutics Limited is a Singapore-based holding company, with main business activities managed by its wholly-owned Malaysian subsidiary, CytoMed Malaysia[598](index=598&type=chunk) [Property, Plants and Equipment](index=128&type=section&id=D.%20Property%2C%20Plants%20and%20Equipment) The company owns a Singapore leasehold for its office and R&D lab, and a freehold cGMP facility in Johor, Malaysia - The company owns the leasehold for its Singapore office and R&D lab at 1 Commonwealth Lane, valid until March 1, 2038[428](index=428&type=chunk) - The company owns a freehold, three-story cGMP facility in Johor, Malaysia, with approximately **8,600 square feet** of gross floor area[432](index=432&type=chunk)[434](index=434&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=128&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) This section analyzes the company's financial performance, highlighting increasing net losses, IPO-supported liquidity, cash flows, and funding requirements [Operating Results](index=128&type=section&id=A.%20Operating%20Results) The company reported no revenue from 2021-2023, with net loss increasing to S$4.13 million in 2023 due to higher IPO and public company expenses - The company, a pre-clinical stage entity, has not generated any revenue from product sales since its inception[606](index=606&type=chunk)[608](index=608&type=chunk) - Other expenses surged to **S$2.21 million** in 2023 from **S$0.49 million** in 2022, primarily due to offering and public company costs[620](index=620&type=chunk) - Research income, from manufacturing cells for researchers on a cost-recovery basis, increased by **39.5%** in 2023 to **S$507,736**[609](index=609&type=chunk)[611](index=611&type=chunk) Consolidated Statement of Profit or Loss (S$) | | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | **Revenue** | - | - | - | | **Other operating income** | 154,610 | 485,374 | 803,904 | | **Research expenses** | (1,090,623) | (1,522,765) | (1,589,693) | | **Other expenses** | (518,766) | (494,675) | (2,213,142) | | **Loss for the year** | **(2,051,903)** | **(3,131,452)** | **(4,133,170)** | [Liquidity and Capital Resources](index=135&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily funded by its S$10.31 million IPO proceeds, with cash and equivalents increasing to S$9.00 million by year-end 2023 - The company's IPO on April 18, 2023, raised net proceeds of approximately **S$10.31 million** (**U.S.$7.81 million**)[604](index=604&type=chunk) Cash and Cash Equivalents & Accumulated Losses (S$) | As of December 31 | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | **Cash and cash equivalents** | S$2.51 million | S$1.58 million | S$9.00 million | | **Accumulated losses** | S$5.07 million | S$8.20 million | S$12.33 million | Summary of Cash Flows (S$) | For the year ended Dec 31 | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | (1,712,985) | (1,398,409) | (3,432,830) | | **Net cash used in investing activities** | (823,666) | (473,305) | (2,829,175) | | **Net cash generated from financing activities** | 4,173,396 | 968,716 | 10,919,885 | [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=141&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section details the company's leadership, compensation practices, board structure, and employee base, including its 34 full-time employees [Directors and Senior Management](index=141&type=section&id=A.%20Directors%20and%20Senior%20Management) The company's leadership comprises a nine-member Board of Directors, including four executive and five independent directors, along with key executive officers - The Board of Directors comprises **9** members: **4** executive directors and **5** independent directors[664](index=664&type=chunk)[699](index=699&type=chunk) [Compensation](index=148&type=section&id=B.%20Compensation) This subsection details 2023 compensation for Named Executive Officers and non-employee directors, including annual cash retainers and the adoption of a Clawback Policy - Non-employee directors receive annual cash retainers for Board service (**U.S.$12,000**) and committee service, with additional retainers for chairpersons[697](index=697&type=chunk) 2023 Named Executive Officer Compensation (U.S.$) | Name and Principal Position | Salary (U.S.$) | Bonus (U.S.$) | All Other Compensation (U.S.$) | Total (U.S.$) | | :--- | :--- | :--- | :--- | :--- | | **CHOO Chee Kong**, Chairman | 23,043 | - | 4,273 | 27,316 | | **Dr. ZENG Jieming**, Chief Scientific and Medical Officer | 88,226 | 1,516 | - | 89,742 | | **Dr. TAN Wee Kiat**, Co-CEO and COO | 86,614 | 1,516 | - | 88,130 | [Employees](index=152&type=section&id=D.%20Employees) The company employs 34 full-time staff, with 28 in R&D and manufacturing, and has adopted a 2023 Equity Incentive Plan - The company has **34** full-time employees, with **28** (approximately **82%**) focused on R&D and manufacturing[713](index=713&type=chunk) - The company adopted the 2023 Equity Incentive Plan, making **1,279,117** ordinary shares available for issuance as share options or restricted shares[717](index=717&type=chunk)[718](index=718&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=155&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section details the company's ownership structure, including major shareholders, and significant related party transactions [Major Shareholders](index=155&type=section&id=A.%20Major%20Shareholders) The company's ownership is concentrated among a few major shareholders, with Glorious Finance Limited holding **40.33%** and all directors and NEOs owning **33.31%** Beneficial Ownership of Ordinary Shares (%) | Shareholder | Number of Shares | Percentage (%) | | :--- | :--- | :--- | | Glorious Finance Limited | 4,653,604 | 40.33% | | mDR Limited | 1,336,923 | 11.59% | | WANG Shu | 883,858 | 7.66% | | ZENG Jieming | 589,239 | 5.11% | | All directors and NEOs as a group (9 persons) | 3,844,299 | 33.31% | [Related Party Transactions](index=156&type=section&id=B.%20Related%20Party%20Transactions) Significant related party transactions include Chairman CHOO Chee Kong's personal guarantees for loans and the company's investment in Landmark Medical Centre - Chairman CHOO Chee Kong provided a personal guarantee for a **RM2 million** credit facility for the Malaysian subsidiary's cGMP Facility construction[737](index=737&type=chunk) - The company acquired a **20%** equity stake in Landmark Medical Centre Sdn Bhd (LMC), a private hospital where director Dr. Lucas LUK Tien Wee is a shareholder and Medical Director[743](index=743&type=chunk) [ITEM 8. FINANCIAL INFORMATION](index=159&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section confirms the inclusion of financial statements, absence of significant legal proceedings, and the company's policy of retaining earnings for business expansion - The company has not been subject to any significant legal or arbitration proceedings[753](index=753&type=chunk) - The company does not intend to pay dividends in the near future, planning to retain earnings to finance business expansion[757](index=757&type=chunk) [ITEM 10. ADDITIONAL INFORMATION](index=161&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) This section covers supplementary corporate information, including material contracts, exchange controls, and detailed taxation considerations for Singapore and U.S. Holders [Taxation](index=161&type=section&id=E.%20Taxation) This subsection details material tax implications for investors in Singapore and the United States, including the risk of PFIC classification for U.S. Holders - Under Singapore's one-tier tax system, dividends paid by the company are tax-exempt for shareholders, regardless of residency[780](index=780&type=chunk) - Singapore does not impose tax on capital gains, though gains from share disposal could be considered income if from trade or business activities[781](index=781&type=chunk) - There is a risk the company could be classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, leading to adverse tax treatment for U.S. Holders[803](index=803&type=chunk)[805](index=805&type=chunk) PART II [ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS](index=168&type=section&id=ITEM%2014.%20MATERIAL%20MODIFICATIONS%20TO%20THE%20RIGHTS%20OF%20SECURITY%20HOLDERS%20AND%20USE%20OF%20PROCEEDS) This section addresses the use of proceeds from the company's IPO, confirming approximately S$10.31 million in net proceeds and no material change in their planned use - The company's Initial Public Offering (IPO) generated net proceeds of approximately **S$10.31 million** (**U.S.$7.81 million**)[824](index=824&type=chunk) - As of December 31, 2023, there has been no material change in the intended use of IPO proceeds as described in the registration statement[825](index=825&type=chunk) [ITEM 15. CONTROLS AND PROCEDURES](index=168&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) This section discusses the ineffectiveness of the company's disclosure controls and procedures as of December 31, 2023, due to insufficient financial reporting personnel - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were ineffective[826](index=826&type=chunk) - The ineffectiveness stemmed from insufficient financial reporting and accounting personnel with adequate knowledge of U.S. GAAP and SEC reporting requirements[826](index=826&type=chunk) [ITEM 16. CORPORATE GOVERNANCE AND OTHER DISCLOSURES](index=170&type=section&id=ITEM%2016.%20CORPORATE%20GOVERNANCE%20AND%20OTHER%20DISCLOSURES) This section covers corporate governance, including the Audit Committee Financial Expert, Code of Ethics, accountant fees, home country practices, and controlled company status - The board identified Mark LEONG Kei Wei as the 'Audit Committee Financial Expert'[833](index=833&type=chunk) - As a foreign private issuer, the company follows Singaporean home country practice for shareholder meeting quorum and is exempt from Nasdaq's independent director majority rule[842](index=842&type=chunk) - The company is a 'controlled company' under Nasdaq rules due to principal shareholders, officers, and directors holding a majority of its ordinary shares[843](index=843&type=chunk) Principal Accountant Fees (U.S.$) | Fee Type | 2022 (U.S.$) | 2023 (U.S.$) | | :--- | :--- | :--- | | Audit Fees | 70,000 | 85,000 | | Audit-Related Fees | 18,000 | 20,000 | | Tax Fees | - | - | | All Other Fees | - | - | PART III [ITEM 18. FINANCIAL STATEMENTS](index=173&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) This section presents the audited consolidated financial statements for CytoMed Therapeutics Limited and its subsidiaries for the three years ended December 31, 2023 [Consolidated Statements of Financial Positions](index=179&type=section&id=Consolidated%20Statements%20of%20Financial%20Positions) Total assets significantly increased to S$12.37 million in 2023, while total liabilities decreased to S$1.12 million, leading to a substantial rise in total equity Consolidated Statements of Financial Positions (S$) | | 2022 | 2023 | | :--- | :--- | :--- | | **Total current assets** | 2,493,862 | 10,096,631 | | **Total non-current assets** | 2,733,196 | 2,272,239 | | **Total assets** | **5,227,058** | **12,368,870** | | **Total current liabilities** | 4,165,224 | 716,943 | | **Total non-current liabilities** | 475,536 | 407,772 | | **Total liabilities** | **4,640,760** | **1,124,715** | | **Total equity** | **586,298** | **11,244,155** | [Consolidated Statements of Profit or Loss and Other Comprehensive Loss](index=180&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Loss) The company reported no revenue from 2021-2023, with the annual loss widening to S$4.13 million in 2023 due to increased expenses Consolidated Statements of Profit or Loss and Other Comprehensive Loss (S$) | | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | **Revenue** | - | - | - | | **Loss before income tax** | (2,051,903) | (3,129,812) | (4,132,517) | | **Loss for the year** | **(2,051,903)** | **(3,131,452)** | **(4,133,170)** | | **Total comprehensive loss for the year** | **(2,074,531)** | **(3,227,956)** | **(4,223,088)** | [Consolidated Statements of Changes in Equity](index=182&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity significantly increased to S$11.24 million by end of 2023, primarily driven by S$14.81 million in new share issuances from IPO and loan conversions Consolidated Statements of Changes in Equity (S$) | | Share capital | Accumulated losses | Total equity | | :--- | :--- | :--- | :--- | | **Balance at Dec 31, 2021** | 6,548,960 | (5,067,332) | 2,591,604 | | **Total comprehensive loss for 2022** | - | (3,131,209) | (3,227,956) | | **Issuance of shares in 2022** | 2,364,045 | - | 1,222,650 | | **Balance at Dec 31, 2022** | 8,913,005 | (8,198,541) | 586,298 | | **Total comprehensive loss for 2023** | - | (4,132,896) | (4,223,088) | | **Issuance of shares in 2023** | 14,807,015 | - | 14,807,015 | | **Balance at Dec 31, 2023** | **23,720,020** | **(12,331,437)** | **11,244,155** | [Consolidated Statements of Cash Flows](index=183&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used S$3.43 million in cash for 2023, while financing activities provided S$10.92 million, resulting in a net increase in cash and equivalents to S$6.22 million Consolidated Statements of Cash Flows (S$) | | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | (1,712,985) | (1,398,409) | (3,432,830) | | **Net cash used in investing activities** | (823,666) | (473,305) | (2,829,175) | | **Net cash from financing activities** | 4,173,396 | 968,716 | 10,919,885 | | **Net increase/(decrease) in cash** | 1,636,745 | (902,998) | 4,657,880 | | **Cash and cash equivalents at end of year** | **2,512,768** | **1,579,718** | **6,224,187** |