CytoMed Therapeutics (US:GDTC)2025-04-28 20:50PART I ITEM 3. KEY INFORMATION This section details the significant financial, business, manufacturing, and intellectual property risks facing the company Risk Factors 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 201835 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 commercialized5164 - 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 development142171 - 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 requirements269299 ITEM 4. INFORMATION ON THE COMPANY This section provides an overview of the company's history, business strategy, product pipeline, and assets History and Development of the Company 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 Depository331332 - A 1-for-380.83 reverse stock split was effected on January 17, 2023, prior to its public listing333 Business Overview 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 treatments338351 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 date340377 - 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 NPRA349357 - 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 estate347 Organizational Structure 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 Depository664 Property, Plants and Equipment 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 2038473 - It owns a freehold, three-story cGMP facility in Johor, Malaysia, with approximately 8,600 square feet of gross floor area480482 - Through a subsidiary, the company acquired two freehold properties in Malaysia housing a cord blood bank facility in late 2024485 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS Management analyzes the company's financial condition, operating results, and liquidity for fiscal years 2022-2024 Operating Results 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$69,501 in FY 2024, derived from its newly acquired private blood banking services677 Key Financial Results (S$) | 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 Trial685 - Other expenses decreased by S$1.22 million in 2024, mainly because of the absence of S$758,563 in IPO-related expenses that were incurred in 2023691 Liquidity and Capital Resources Operations are funded by private equity and IPO proceeds, with future financing needed as clinical programs advance Cash and Cash Equivalents (S$) | 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$10.31 million from its Initial Public Offering in April 2023672 Directors, Senior Management and Employees This section provides information on the company's leadership team, compensation practices, and employee base Directors and Senior Management The leadership includes a six-member Board with four independent directors and a five-person senior management team - The Board of Directors consists of 6 members: Chairman CHOO Chee Kong, Dr. ZENG Jieming, and four independent directors (Prof. LOH Yuin Han, Dr. YEW Chak Hua, Mark LEONG Kei Wei, Dr. TOH Keng Kiat)732759 - The executive management team includes CHOO Chee Kong (Chairman), Dr. ZENG Jieming (CSO & Medical Officer), Dr. Lucas LUK Tien Wee (Chief Clinical Officer), GOH Yvonne (CFO), and TAN Yoong Ying (Chief Corporate Officer)736 Compensation This subsection details compensation for Named Executive Officers and non-employee directors for fiscal year 2024 2024 Named Executive Officer Compensation | Name and Principal Position | Total Compensation (U.S.$) | | :--- | :--- | | 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.$12,000) and its committees, with additional retainers for chairpersons757 - The company adopted an Executive Compensation Recovery (Clawback) Policy on November 16, 2023, as required by Nasdaq listing standards758 Board Practices The Board has four independent directors and three key committees: Audit, Compensation, and Nominating/Governance - The Board has three key committees: Audit, Compensation, and Nominating and Corporate Governance, all established on April 18, 2023759 - The Audit Committee is chaired by Mark LEONG Kei Wei, who is designated as the "audit committee financial expert"760 Employees As of the report date, the company has 43 full-time employees and maintains an equity incentive plan - The company has 43 full-time employees, with 28 dedicated to R&D and manufacturing771 - The 2023 Equity Incentive Plan reserves 1,279,117 ordinary shares for awards such as share options and restricted shares to employees, directors, and consultants775776 Major Shareholders and Related Party Transactions This section discloses the company's ownership structure and details material transactions with related entities Major Shareholders Ownership is concentrated, with Glorious Finance Limited holding 32.70% and directors/NEOs holding 28.28% as a group Major Shareholders (5% or more) | Shareholder | Ownership Percentage | | :--- | :--- | | Glorious Finance Limited | 32.70% | | mDR Limited | 10.59% | | WANG Shu | 7.66% | | 28 Consultants Limited | 6.20% | | ZENG Jieming | 5.11% | - All directors and NEOs as a group beneficially own 28.28% of the company's ordinary shares794 Related Party Transactions The company engaged in transactions with its 20%-owned associate, Landmark Medical Centre Sdn Bhd (LMC) - The company holds a 20% equity stake in Landmark Medical Centre Sdn Bhd (LMC), a private hospital in Malaysia797 Research Income from LMC (S$) | Year | Research Income | | :--- | :--- | | 2022 | 207,206 | | 2023 | 183,518 | | 2024 | 115,277 | Financial Information 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 proceedings806 - The company does not anticipate paying dividends in the near future, intending to retain any earnings for business expansion810 Additional Information This section provides supplementary corporate details, including material tax considerations for investors Taxation 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 gains831833834 - Malaysia Tax: Malaysia operates on a territorial tax principle and dividends distributed by Malaysian companies are exempt from tax in the hands of shareholders847858 - 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. Holders870 PART II Material Modifications to the Rights of Security Holders and Use of Proceeds This section confirms no changes to shareholder rights and updates the use of IPO proceeds Use of Proceeds 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$10.31 million in net proceeds from its IPO, which was completed on April 18, 2023891 - As of December 31, 2024, the company confirms no material change in the use of proceeds from its registration statement892 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of December 31, 2024 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024893 - As a newly public company, the annual report does not yet include a management assessment or auditor attestation on internal control over financial reporting, per SEC transition rules896897 Corporate Governance and Other Disclosures This section details corporate governance matters, including committee experts, accountant fees, and cybersecurity risks - The board has determined that Mark LEONG Kei Wei is an "Audit Committee Financial Expert"900 Principal Accountant Fees (WWC, P.C.) | Fee Type | 2022 (U.S.$) | 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 rules909 - The company has implemented protocols to manage cybersecurity risks, overseen by the Chief Corporate Officer, Ms. TAN Yoong Ying, who reports to the board919921 PART III Financial Statements 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) |