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CytoMed Therapeutics announces Chairman’s Letter to the Company’s shareholders

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CytoMed Therapeutics (NASDAQ: GDTC) released a chairman's letter highlighting key achievements in 2024 and outlining plans for 2025. The company, based in Singapore and Malaysia, specializes in producing affordable GMP-grade immune cells for cancer and autoimmune disease treatment.

Key 2024 accomplishments include: becoming a clinical-stage biopharma with the initiation of the ANGELICA trial, the first-in-human CAR T trial using donor-derived allogeneic gamma delta T cells; acquiring a licensed cord blood bank for US$450,000; establishing strategic collaborations in China and India; advancing iPSC-derived hybrid immune cell development; and participating in an AI project for infectious diseases treatment.

For 2025, CytoMed plans to: release initial ANGELICA trial results by mid-year; submit a US FDA IND for their allogeneic gamma delta T cells; establish presence in New York; and implement revenue-generating methods through compassionate use programs. The company reports having over one year of cash runway from their US$10 million NASDAQ IPO.

CytoMed Therapeutics (NASDAQ: GDTC) ha pubblicato una lettera del presidente evidenziando i principali successi nel 2024 e delineando i piani per il 2025. L'azienda, con sede a Singapore e Malesia, si specializza nella produzione di cellule immunitarie GMP a prezzi accessibili per il trattamento del cancro e delle malattie autoimmuni.

I principali traguardi del 2024 includono: diventare una biopharma in fase clinica con l'avvio del trial ANGELICA, il primo trial CAR T in umani che utilizza cellule T gamma delta allogeniche derivate da donatori; l'acquisizione di una banca di sangue cordonale autorizzata per 450.000 dollari; l'instaurazione di collaborazioni strategiche in Cina e India; il progresso nello sviluppo di cellule immunitarie ibride derivate da iPSC; e la partecipazione a un progetto di intelligenza artificiale per il trattamento delle malattie infettive.

Per il 2025, CytoMed prevede di: rilasciare i risultati preliminari del trial ANGELICA entro metà anno; presentare un IND alla FDA degli Stati Uniti per le loro cellule T gamma delta allogeniche; stabilire una presenza a New York; e implementare metodi di generazione di entrate tramite programmi di uso compassionevole. L'azienda riporta di avere oltre un anno di liquidità dalla loro IPO di 10 milioni di dollari su NASDAQ.

CytoMed Therapeutics (NASDAQ: GDTC) publicó una carta del presidente destacando los logros clave en 2024 y esbozando planes para 2025. La empresa, con sede en Singapur y Malasia, se especializa en la producción de células inmunitarias de grado GMP asequibles para el tratamiento del cáncer y enfermedades autoinmunitarias.

Los logros clave de 2024 incluyen: convertirse en una biofarmacéutica en etapa clínica con el inicio del ensayo ANGELICA, el primer ensayo CAR T en humanos que utiliza células T gamma delta alogénicas derivadas de donantes; adquirir un banco de sangre umbilical licenciado por 450,000 dólares; establecer colaboraciones estratégicas en China e India; avanzar en el desarrollo de células inmunitarias híbridas derivadas de iPSC; y participar en un proyecto de inteligencia artificial para el tratamiento de enfermedades infecciosas.

Para 2025, CytoMed planea: liberar los resultados iniciales del ensayo ANGELICA a mediados de año; presentar un IND a la FDA de EE. UU. para sus células T gamma delta alogénicas; establecer presencia en Nueva York; e implementar métodos de generación de ingresos a través de programas de uso compasivo. La empresa informa tener más de un año de capital disponible tras su OPI de 10 millones de dólares en NASDAQ.

CytoMed Therapeutics (NASDAQ: GDTC)는 2024년 주요 성과를 강조하고 2025년 계획을 개요한 의장 서한을 발표했습니다. 싱가포르와 말레이시아에 본사를 둔 이 회사는 암 및 자가 면역 질환 치료를 위한 저렴한 GMP 등급 면역 세포 생산에 전문화되어 있습니다.

2024년의 주요 성과로는: 기증자 유래의 Allogeneic 감마 델타 T세포를 사용하는 첫 번째 인체 CAR T 시험인 ANGELICA 시험의 시작으로 임상 단계 바이오 제약으로의 전환; 450,000달러에 인증된 제대혈 은행을 인수; 중국과 인도에서 전략적 협력 구축; iPSC 유래 하이브리드 면역 세포 개발의 진전; 및 감염병 치료를 위한 AI 프로젝트에 참여 등이 있습니다.

2025년을 위해 CytoMed는: 연중 중반에 ANGELICA 시험의 초기 결과를 발표할 계획; Allogeneic 감마 델타 T세포에 대한 미국 FDA IND 제출; 뉴욕에 존재감을 확립; 그리고 동정적 사용 프로그램을 통한 수익 창출 방법을 구현할 계획입니다. 회사는 1천만 달러 NASDAQ IPO에서 1년 이상의 현금이 남아 있다고 보고합니다.

CytoMed Therapeutics (NASDAQ: GDTC) a publié une lettre du président mettant en avant les réalisations clés de 2024 et esquissant les plans pour 2025. La société, basée à Singapour et en Malaisie, se spécialise dans la production de cellules immunitaires de qualité GMP à prix abordable pour le traitement du cancer et des maladies auto-immunes.

Les principales réalisations de 2024 incluent : devenir une biopharma en phase clinique avec le lancement de l'essai ANGELICA, le premier essai CAR T chez l'homme utilisant des cellules T gamma delta allogéniques dérivées de donneurs ; l'acquisition d'une banque de sang de cordon licenciée pour 450 000 dollars ; l'établissement de collaborations stratégiques en Chine et en Inde ; l'avancement du développement de cellules immunitaires hybrides dérivées de cellules iPSC ; et la participation à un projet d'IA pour le traitement des maladies infectieuses.

Pour 2025, CytoMed prévoit de : publier les résultats initiaux de l'essai ANGELICA d'ici le milieu de l'année ; soumettre une demande IND à la FDA américaine pour leurs cellules T gamma delta allogéniques ; établir une présence à New York ; et mettre en œuvre des méthodes génératrices de revenus à travers des programmes d'utilisation compassionnelle. La société rapporte disposer de plus d'un an de liquidités grâce à son IPO de 10 millions de dollars sur le NASDAQ.

CytoMed Therapeutics (NASDAQ: GDTC) veröffentlichte einen Brief des Vorsitzenden, der die wichtigsten Erfolge im Jahr 2024 hervorhebt und die Pläne für 2025 umreißt. Das in Singapur und Malaysia ansässige Unternehmen ist auf die Produktion kostengünstiger, GMP-konformer Immunzellen für die Behandlung von Krebs und Autoimmunerkrankungen spezialisiert.

Zu den wichtigsten Errungenschaften im Jahr 2024 gehören: die Entwicklung zu einem klinischen Biopharmaunternehmen mit dem Start der ANGELICA-Studie, der ersten CAR-T-Studie am Menschen unter Verwendung von von Spendern abgeleiteten allogenen Gamma-Delta-T-Zellen; der Erwerb einer lizenzierten Nabelschnurblutbank für 450.000 US-Dollar; die Etablierung strategischer Kooperationen in China und Indien; der Fortschritt bei der Entwicklung hybridisierter Immunzellen aus iPSC; und die Teilnahme an einem KI-Projekt zur Behandlung von Infektionskrankheiten.

Für 2025 plant CytoMed: die Veröffentlichung der ersten Ergebnisse der ANGELICA-Studie bis zur Jahresmitte; die Einreichung eines IND bei der FDA der USA für ihre allogenen Gamma-Delta-T-Zellen; die Etablierung einer Präsenz in New York; und die Implementierung von Einnahme-generierenden Methoden durch Mitgefühl-Nutzungsprogramme. Das Unternehmen berichtet, dass es über ein Jahr Cash-Reserven aus ihrem 10-Millionen-Dollar-IPO an der NASDAQ verfügt.

Positive
  • Initiated first-in-human ANGELICA CAR T clinical trial
  • Acquired cord blood bank for US$450,000, securing cost-free raw materials
  • Established strategic partnerships in China and India markets
  • Secured significant grant from National Medical Research Council of Singapore
  • Achieved decent topline growth (unaudited)
  • Maintains over one year cash runway
Negative
  • Small IPO raise of only US$10M gross (US$8M net)
  • Plans for additional financing in 2025 indicating potential dilution
  • patient scope in Phase 1 trial (under 20 patients)

Insights

The shareholder letter reveals CytoMed's strategic positioning as a disruptive force in the cell therapy market, particularly through their focus on affordable, off-the-shelf allogeneic gamma delta T cells. Their approach addresses several critical industry pain points:

Strategic Cost Advantages: Operating from Singapore and Malaysia provides significant cost benefits in manufacturing GMP-grade immune cells. This is particularly important given that traditional CAR-T therapies often cost $400,000+ per treatment in Western markets.

Market Expansion Strategy: The company's three-pronged approach is noteworthy:

  • The $450,000 cord blood bank acquisition provides cost-free raw materials access, a significant competitive advantage in developing cord blood-derived therapeutics
  • Strategic partnerships in China and India leverage these markets' cost advantages while accessing large patient populations
  • Focus on medical tourism in Asia creates a unique commercialization pathway, potentially bypassing lengthy traditional approval processes

Technology Platform Value: The ANGELICA trial represents a significant milestone as the world's first donor-derived allogeneic CAR gamma delta T cell trial. This 'off-the-shelf' approach could potentially address both blood and solid tumors, a important differentiator from traditional CAR-T therapies.

Financial Position: While the $8M net IPO proceeds appear modest, the company's lean operational structure and strategic focus on low-cost regions provide adequate runway. The planned 2025 financial strengthening could coincide with clinical readouts, potentially offering better financing terms.

The company's approach to developing affordable allogeneic therapies, combined with its Asian cost advantages and focus on medical tourism, presents a unique value proposition in the cellular therapy space. However, investors should monitor clinical trial results expected mid-2025 as a key catalyst for future growth.

SINGAPORE, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or the “Company”) today released a letter to shareholders from the Chairman of the Company’s Board of Directors (the “Board”) as it welcomes the new year ahead of its full-year audited results announcement due by end-April, the full text of which is provided below. All shareholders of CytoMed are encouraged to read.

Dear Shareholders,

The Board of CytoMed wishes you a healthy and prosperous Year of the Snake.

The snake’s ability to shed its skin is often compared to rebirth and renewal, representing adaptability and growth in Chinese mythology. The snake’s calm and quiet nature also embodies deep thought and strategic planning to embrace change and explore new possibilities. Its connection to transformation makes the Snake Year a relevant time for pursuing ambitious goals and doing things differently from others in the same bio-eco system.

But first a quick recap.

Based in Singapore and Malaysia, we are not in cancer targets discovery, a disease diagnostic company, a research biotech nor medical device company or a CDMO or CRO. Capitalizing on Asia’s low-cost infrastructure and talents, we make affordable GMP-grade immune cells to be infused into no-option patients to alleviate their cancers or autoimmune diseases. This operation continued to grow in 2024 especially with rising interest from doctors and researchers in donor-derived off-the-shelf allogeneic gamma delta T cells, a rare subset of cancer-killing T cells. We are proud of our accomplishments in 2024 driven by our dedicated employees and management team along with the effectiveness of our strategy. We achieved decent growth in our topline (based on the unaudited financials), product development, strategic partnership and internationalization. Details will be announced when available.

Here is a quick recap of our accomplishments in 2024 and an outline of our direction for 2025:

Clinical stage biopharma

Late last year, CytoMed became a clinical stage biopharma with the first patient safely dosed in November 2024 under a clinical trial approved in Singapore.  Termed ANGELICA trial, this is a first-in-human CAR T trial in the world involving CytoMed’s patented donor-derived allogeneic gamma delta T cells which express a chimeric antigen receptor (“CAR”) which can recognize many types of cancers, both hematological and solid cancers. As a phase 1 trial, the number of patients to be recruited is typically small, not more than 20 late stage cancers.  The National Medical Research Council of Singapore has awarded a significant grant to implement this trial in Singapore.

Successful acquisition of a licenced cord blood bank

This cord blood bank will provide rare and precious cord blood as cost-free raw materials for our strategic expansion into a new class of cord blood-derived therapeutics for auto-immunes and cancers due to its naïve cord properties. We purchased this bank for approximately US$ 450,000 and intend to spinoff this subsidiary in future as a separate cord blood-based biopharma for example manufacturing cord blood-derived Natural Killer cells, widely researched for its safe and potentially effective remedy for autoimmune diseases. There are few providers of cord blood-derived therapeutics due to the unavailability of low cost cord blood units.  

International strategic partnership

We initiated strategic collaboration to bring our technology to China and India, two nearby large Asian economies with abundant cancer cases.  We can also tap on these low cost regional countries to make affordable therapies. China scientists reportedly now publish the most research papers in the world. India is well-known to make very affordable medicines.

One step closer to the clinic for our novel hybrid immune cell made from induced pluripotent stem cells (“iPSC”)

CytoMed has generated the critical cell banks for the iPSC-derived hybrid of gamma delta T and Natural Killer cell technology and is currently undergoing process development into a potentially very potent cancer-killing immunotherapy product to treat a range of cancers.

Artificial Intelligence (“AI”) project

We are participating in a proposed international project involving the use of AI and our gamma delta T cells in the treatment of infectious diseases in developing countries.

Tapping on fast growing medical tourism in Asia

Looking ahead to 2025, an important milestone is our initial clinical readout of our ANGELICA trial anticipated by mid of this year. We are also working on submitting a US FDA IND for our donor-derived allogeneic gamma delta T cells. We continue to seek out like-minded partners especially to deploy our allogeneic gamma delta T cells in combinational therapies such as with antibodies. To enhance our profile in the US, we are establishing a presence in New York so we can be in the same time zone, be closer to our US investors and look out for opportunities including M&A, strategic alliances and learn of new technologies. As Chairman and substantial shareholder of CytoMed, to show commitment and resolve to our shareholders, the US presence will be motivated and funded in my private capacity using personal donated shares and will not risk the Company’s resources.

In summary, be like the snake and transform, renew. International medical tourism in Asia is fast growing so there are lots of opportunities to develop this new science of cell therapy which is very expensive in the West or inaccessible despite passing of the Right-to-Try bill in the US due to fear of litigation in the US. In 2025, we intend to implement radical revenue-generating methods to address no-option late stage diseased patients on a compassionate, or named patient basis (alternatively known as special access or accelerated access programme depending on which regulator) including investing in clinics and partnering hospitals and medical cancer centres in the region. Although our IPO on NASDAQ in 2023 was very modest raising only US$ 10 million gross (net US$ 8 million after expenses), due to our cost-efficient operations in Asia and exercising financial prudence, we have sufficient cash runway of more than a year. We should prepare to strengthen our financials at the right time in 2025 and plan well ahead for funds to pounce on new opportunities including M&A. The team is very busy with many projects.

DeepSeek is AI’s disruptor for its low R&D investment cost and accessibility. Low cost allogeneic off-the-shelf cell therapies for various types of cancers, both hematological and solid cancers, may be biotech’s DeepSeek moment.

Happy new year of the Snake!

About CytoMed Therapeutics Limited (CytoMed)

Incorporated in 2018, CytoMed was spun off from the Agency for Science, Technology and Research (A*STAR), Singapore’s leading research and development agency in the public sector. CytoMed is a biopharmaceutical company focused on harnessing its licensed proprietary technologies, namely gamma delta T cell and iPSC-derived gamma delta Natural Killer T cell, to create novel cell-based allogeneic immunotherapies for the treatment of various human cancers. The development of novel technologies has been inspired by the clinical success of existing CAR-T therapies in treating haematological malignancies, as well as the current clinical limitations and commercial challenges in extrapolating the CAR-T principle into the treatment of solid tumours. For more information, please visit www.cytomed.sg and follow us on Twitter (“X”) @CytomedSG, on LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s plans to develop and commercialize its product candidates; the initiation, timing, progress and results of the Company’s current and future pre-clinical studies and clinical trials and the Company’s R&D programs; the Company’s expectations regarding the impact of future COVID-19 outbreak on its business, the Company’s industry and the economy; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s ability to successfully acquire or obtain licenses for additional product candidates on reasonable terms; the Company’s ability to establish and maintain collaborations and/or obtain additional funding and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof.

Contact :

CytoMed Therapeutics Limited
enquiry@cytomed.sg
Attention : Evelyn Tan, Chief Corporate Officer


FAQ

What is the status of CytoMed's (GDTC) ANGELICA clinical trial?

The ANGELICA trial, a first-in-human CAR T trial using donor-derived allogeneic gamma delta T cells, began in November 2024 with the first patient safely dosed. Initial results are expected by mid-2025.

How much did CytoMed (GDTC) raise in their NASDAQ IPO?

CytoMed raised US$10 million gross (US$8 million net after expenses) in their 2023 NASDAQ IPO.

What was the acquisition cost of CytoMed's (GDTC) cord blood bank?

CytoMed acquired the licensed cord blood bank for approximately US$450,000.

What are CytoMed's (GDTC) expansion plans for 2025?

CytoMed plans to establish a presence in New York, submit a US FDA IND for allogeneic gamma delta T cells, implement revenue-generating methods through compassionate use programs, and strengthen their financials.

How many patients will be included in CytoMed's (GDTC) ANGELICA trial?

As a phase 1 trial, ANGELICA will recruit no more than 20 late-stage cancer patients.
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