On March 24, 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker: ALOPM), a clinical-stage company developing innovative therapies to overcome immune evasion and drug resistance, reported the submission to Swiss authorities of the study protocol for its Phase 1b/2a clinical trial REVERT (RIPK2 for rEsistant and adVanced mElanoma tReatmenT) with OPM-101, its RIPK2 inhibitor in advanced melanoma patients with resistance to anti-PD-1 (Press release, Oncodesign Precision Medicine, MAR 24, 2025, https://www.businesswire.com/news/home/20250324831272/en/Oncodesign-Precision-Medicine-OPM-Announces-Protocol-Submission-for-its-Phase-1b2a-Study-REVERT-for-OPM-101-in-Combination-with-Pembrolizumab-in-Patients-with-Advanced-Melanoma-Resistant-to-Anti-PD1 [SID1234651382]). This submission of the study protocol follows the announcement of positive results from the Phase 1 study in October 2024.

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OPM-101 is a first-in-class RIPK2 inhibitor administered orally, with the potential to treat several cancers. This milestone underscores OPM’s commitment to addressing significant unmet medical needs in oncology.

Globally, melanoma accounts for approximately 325,000 new cases and more than 57,000 deaths annually, with the highest incidences observed in regions such as Europe, North America, and Oceania. In Europe, the incidence of melanoma is rising, and there is an increasing focus on improving treatments for patients who develop resistance to immune checkpoint inhibitors (ICIs) like anti-CTLA4 and anti-PD1/PD-L1 therapies. Although ICIs have become a cornerstone of advanced melanoma treatment for several years, approximately 40-60% of patients experience resistance or progression, creating a pressing need for innovative therapeutic options.

In experimental cancer models, the addition of OPM-101 to anti-PD-1 antibody therapy has been shown to significantly enhance anti-tumor efficacy and promote greater sensitivity to PD-1 blockade, delaying or reducing loss of response to ICI therapy and demonstrating durable responses in preclinical models studied to date. The OPM team has shown that the underlying mechanisms of OPM-101 involve enhanced tumor antigen presentation and recognition, associated with remodelling of CD8+ T cell infiltration into the tumor stroma. Moreover, OPM-101 alone has also demonstrated significant antitumor activity based on its immunomodulatory properties.

REVERT Study Objectives and Design

This Phase 1b/2a clinical trial is an international, multicenter, open-label study designed to assess the safety and preliminary efficacy of OPM-101 in combination with pembrolizumab in metastatic melanoma patients treated with anti-PD-1 monotherapy or combination therapy (except with anti-LAG-3), and who have developed resistance to this treatment.

The trial will include around 45 patients at 10-13 sites in Switzerland, France, Italy and Spain, and will be conducted through two main phases:

Phase 1b: to assess the safety of OPM-101 in combination with pembrolizumab in patients who have developed resistance to this treatment by anti-PD1, and to select the recommended dose to be used in the second part of the study. This phase will involve a minimum of 6 patients.
Phase 2a: to assess the Disease Control Rate (DCR), safety and key biomarkers associated with immune response with the selected dose of OPM-101 in combination with pembrolizumab in patients who have developed resistance to anti-PD-1. This phase will be conducted on an expanded sample of around 35 patients.
The Phase 1b/2a study builds on the safety data from the Phase 1 study conducted in healthy volunteers (VS) in 2023-2024, which demonstrated a favorable safety profile for OPM-101 and robust pharmacokinetic and pharmacodynamic properties.

The results of Phase 1b will be used to determine the recommended dose for Phase 2a and to gather preliminary efficacy data on a limited number of patients. All data collected during this first phase will be reviewed and analyzed by an independent panel of experts forming the Data and Safety Monitoring Board (DSMB). During this open-label Phase 2a, efficacy data will be generated and reviewed on an ongoing basis, enabling trends in treatment efficacy to be identified before the interim analysis on the first 10 patients receiving the recommended dose and the final analysis on all patients. These efficacy data will be based on the analysis of images obtained for patient follow-up after 12 and 24 weeks of treatment, making it possible to define the Disease Control Rate (DCR) and the Objective Response Rate (ORR). In addition, circulating and tumor biomarkers of antitumor activity will be measured to document OPM-101’s mechanism of action.

The study is coordinated by Pr. Olivier Michielin, Head of the Precision Medicine Oncology Service and Head of the Department of Oncology at Geneva University Hospitals in Switzerland.

Phase 1b of the study will start at the same time in several hospitals in Switzerland. Submission of the application for authorization of the clinical study to the Swiss regulatory authorities (Swissmedic) and to the Ethics Committees of the centers involved in phase 1b of the study, was completed on March 24, 2025. The study is scheduled to start by July 2025.

For phase 2b, patients will be enrolled in additional centers in France, Italy and Spain. Submission of the application for clinical trial authorization in these selected European Union countries will take place in the 4th quarter of 2025, in order to obtain authorization to conduct the extension phase of the study, which could start in the first quarter of 2026.

Completion of this Phase 1b/2a clinical trial is expected by the end of 2027.

"In parallel with phase 1 VS, which enabled us to build a solid foundation around the PK/PD relationship of OPM-101 in humans, we have explored the antitumor activity of our compound alone and in combination with an anti-PD1 in mice. These preclinical results, reinforced by many recent international publications, have convinced us of its major potential in oncology, which is in fact the company’s primary mission.", said Philippe Genne, Chairman and CEO of Oncodesign Precision Medicine. "We are continuing to work on OPM-101’s innovative mechanism of action. In the current financial climate, this study is a major choice for OPM. We are also looking for a pharmaceutical partner to explore its potential in the treatment of IBD – Chronic Inflammatory Bowel Disease."

"Immunotherapy represents a real revolution for many patients suffering from many different types of cancer. This therapeutic approach is fundamentally changing the way we treat cancers by stimulating our immune system to attack and kill cancer cells. These approaches are the result of over a century of investigation and therapeutic advances. Immune checkpoint inhibitors (ICIs) such as anti-PD1s have been used for more than 10 years in several types of cancer, including melanoma and lung cancer. These therapies have proven highly effective with long-lasting responses, marking dramatic progress for many patients," added Jan Hoflack, Scientific Director of Oncodesign Precision Medicine. "Nevertheless, they come with a greater risk of toxicity including immune-related side effects, and a significant number of patients are or become resistant to these approaches. OPM-101, our RIPK2 inhibitor, has the potential to increase the response rate and reduce the side effects of these ICIs. This is what we will be evaluating in this Phase 1b/2a study in melanoma."

Prof. Olivier Michielin, Head of the Precision Oncology Service and Head of the Department of Oncology at the University Hospitals of Geneva, concluded: "Checkpoint inhibitors have revolutionized the management of melanoma. Despite high response rates in the advanced setting and clearly demonstrated long-term benefit, most patients progress under these treatments. Strategies to counteract the mechanisms of resistance to checkpoint inhibitors are therefore essential. OPM’s clinical trial is therefore extremely important, as it addresses exactly this population for whom we lack therapeutic options. What’s more, the prospect of being able to increase the efficacy of checkpoint inhibitors, while reducing toxicity, is of course extremely attractive and will be one of the hypotheses tested with OPM-101, as part of the study."

About OPM-101 in Oncology

OPM-101 is a first-in-class, potent, selective, orally available RIPK2 kinase inhibitor in oncology that has demonstrated the ability to maximize the immunogenicity of tumor cell death and activate a systemic anti-tumor immune response. Although initially linked to chronic inflammatory diseases, the RIPK2 pathway has been increasingly recognized since 2022 as a critical player in tumor progression. In preclinical studies, OPM-101 exhibited synergistic effects with anti-PD1 therapies, enhancing anti-tumor immunity and overcoming resistance in models treated with checkpoint inhibitors alone.

On March 23, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, reported the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab (Press release, CStone Pharmaceauticals, MAR 23, 2025, View Source [SID1234651352]). The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This marks CStone’s second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug’s dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer.

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The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated:

36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS).
56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit.
Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential).
Favorable safety profile, no new safety signals identified.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented: "Following sugemalimab’s approval in Europe for stage IV NSCLC, we are working closely with EMA to expand its indications in earlier stage lung cancer and other malignancies. With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for stage III NSCLC patients. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.

The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.

On March 23, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first participant has been successfully dosed with IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) in a randomized, controlled, multicenter Phase 3 clinical trial (HeriCare-Ovarian01), for platinum-resistant ovarian cancer (PROC) with HER2 expression (Press release, Innovent Biologics, MAR 23, 2025, View Source [SID1234651353]).

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HeriCare-Ovarian01 is the first Phase 3 clinical trial (NCT06834672) in China to investigate PROC with HER2 expression (IHC 1+, 2+ or 3+). The study will evaluate the safety and efficacy of IBI354, compared with investigator’s choice of chemotherapy for PROC with HER2 expression. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 87 participants with platinum-resistant ovarian cancer were enrolled and were treated with 6-12 mg/kg doses of IBI354. 67 (77.0%) participants had previously received at least 3 anti-tumor regimens.

As of July 24, 2024, the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%.
Among them, ORR reached 52.5% and DCR reached 90.0% in 40 ovarian cancer participants treated with 12mg/kg Q3W
ORR reached 55.6% and DCR reached 88.9% in 27 subjects with HER2 IHC 1+ (12mg/kg Q3W dose group).
The median follow-up time of 12mg/kg Q3W dose group was 6.5 months as of the cut-off date, and progression-free survival (PFS) and duration of response (DoR) were not mature. The data was presented at the ESMO (Free ESMO Whitepaper) conference.
In the phase 1/2 clinical study (n=368), IBI354 demonstrated an excellent safety profile.

No DLT was occurred up to 18mg/kg dose group.
The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 21.5%, the incidence of TRAEs leading to dose interruption was 12.2%, the incidence of TRAEs leading to dose reduction was 2.4%, the overall incidence of TRAEs leading to discontinuation was 1.6%, and no TRAE leading to death reported.
The most common TRAEs are nausea, white blood cell count decreased, and anemia. The incidence of interstitial lung disease was only 1.6%, all were grade 1.
The Principal Investigator of the HeriCare-Ovarian01 study, Prof. Qi Zhou from Chongqing University Cancer Hospital, stated, "Prolonging PFS and OS of PROC is an urgent unmet medical need. Ovarian cancer is characterized by a pattern of frequent recurrence, which ultimately leads to platinum resistance. Non-platinum monotherapy chemotherapy remains the primary treatment option at this stage, but its limited efficacy is a major contributor to the high mortality rate associated with ovarian cancer. As a fully-validated target, HER2-targeted therapy has proven effective in breast and gastric cancers. IBI354, as a innovative conjugate of anti-HER2 monoclonal antibody and camptothecin derivative, has shown good anti-tumor activity in PROC with HER2 expression in the previous study. Especially in the population with low HER2 expression (IHC 1+), the efficacy of IBI354 is comparable to that in the population with higher HER2 expression. At the same time, IBI354 has an excellent safety profile, showing a very low risk of common or concerned toxicities of other antibody-drug conjugates (ADCs), such as interstitial lung disease, fatigue, diarrhea, hair loss, eye toxicity, etc. I look forward to positive results from the HeriCare-Ovarian01 study. It is hoped that IBI354 may provide survival benefits to the PROC patients with varying levels of HER2 expression."

The Principal Collaborating Investigator of the study from Zhejiang Cancer Hospital, Prof. Tao Zhu, stated: "We are pleased to complete the first patient enrollment for the HeriCare-Ovarian01 study at our site. Although ovarian cancer ranks third among gynecologic malignancies in incidence, behind cervical and endometrial cancers, its mortality rate exceeds the combined total of the latter two, making it the deadliest gynecologic cancer and a severe threat to women’s health. As an anti-HER2 ADC, preliminary findings from IBI354 have demonstrated encouraging objective response rates (ORR) and disease control rates (DCR) in PROC. Furthermore, IBI354 exhibits a superior clinical safety profile and treatment tolerability compared to other ADCs. Current clinical data suggest promising development prospects for IBI354 in PROC. We are hopeful that IBI354 will achieve success in the HeriCare-Ovarian01 study, offering new therapeutic options for this patient population."

Dr. Zhou Hui, Senior Vice President of Innovent, stated, "I’m pleased that the Phase III clinical study of IBI354 in HER2-expressing PROC has completed the first participant dosing. I look forward to positive results for IBI354 to provide a better treatment option for patients with HER2-expressing PROC. ADC is one of the core technology areas of Innovent’s strategic layout. We combine the world’s leading antibody engineering and multiple sets of differentiated linker-payload technologies to create a highly competitive and innovative TOPO1i ADC technology platform SoloTx. IBI354 has demonstrated excellent safety and efficacy data in the previous study, which fully proves the value and the development strength of Innovent ADC platform. We will deeply layout the ADC and immunotherapy areas, focusing on the next generation of innovation, committed to bring better benefits to cancer patients."

About Ovarian Cancer

OC is one of the leading causes of death among gynecological cancers. According to the International Agency for Research on Cancer, there will be about 324,000 new cases of ovarian cancer worldwide in 2022, and about 206,000 deaths[1]. About 61,000 new cases and 33,000 deaths were reported in China[2]. A higher mortality/morbidity ratio suggests a shorter survival time. Platinum-containing chemotherapy is the first choice for systemic treatment of advanced ovarian cancer. About 70% of patients with platinum-sensitive ovarian cancer will relapse after receiving platinum-containing chemotherapy and eventually develop platinum resistance[3]. There is a lack of effective treatment for platinum-resistant cancer patients. The existing evidence is non-platinum-single drug chemotherapy with or without anti-angiogenic therapy, with ORR only about 4-13.2% and median overall survival (OS) only about 10.9-14 months[4-8]. There is a urgent unmet medical need for PROC, and it is recommended that these patients participate in clinical trials in Chinese and foreign guidelines.It has been reported that about 38% of ovarian cancer patients have HER2 expression[9]. There are currently no anti-HER2 treatments approved for HER2-overexpressed ovarian cancer in China.

About IBI354

IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent’s proprietary novel topoisomerase inhibitor platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals.

With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors.

Starting from the urgent clinical needs, in addition to the phase III study (HeriCare-Ovarian01) already initiated in PROC, Innovent will develop IBI354 in multiple solid tumor indications.

On March 23, 2025 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine (Press release, Everest Medicines, MAR 23, 2025, View Source [SID1234651354]). EVM14 is Everest’s first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company’s efforts to develop innovative mRNA therapeutics in oncology.

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EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens.

In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion – all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies.

"With FDA IND approval, EVM14 has become the Everest’s first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our ‘dual-engine’ strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our ‘AI-powered’ pipeline, underscoring Everest’s leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China’s mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling."

Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future."

According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths1. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases. Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers2, with squamous NSCLC (sq-NSCLC) comprising 25%–30%3. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases4, underscoring the urgent need for new treatment options.

Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually5. more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis6, leading to poor prognosis, high mortality rates, and diminished quality of life.

Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14’s unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development.

Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company’s first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025.

Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale.

About EVM14

EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens.

On March 23, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that it has agreed to sell an aggregate of 10,250,000 shares of its common stock and warrants to purchase up to 10,250,000 shares of common stock priced at-the-market under Nasdaq rules, at a purchase price of $0.98 per share and associated warrant (Press release, TransCode Therapeutics, MAR 23, 2025, View Source [SID1234651355]). The warrants will have an exercise price of $0.86 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. All of the shares of common stock and associated warrants are being offered by the Company. The offering is expected to close on March 25, 2025, subject to satisfaction of customary closing conditions.

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The gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, including related IND-enabling studies, and for working capital and other general corporate purposes.

ThinkEquity is acting as the exclusive placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333- 268764), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 13, 2022, and declared effective on December 16, 2022. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.