Core Points - Transgene is launching a fundraising initiative to raise approximately €105 million through the issuance of new shares, targeting specialized investors via private placement and retail investors through the PrimaryBid platform [2][6] - The company aims to accelerate the development of its myvac® platform, particularly the individualized cancer vaccine TG4050, which has shown promising results in patients with operable head and neck cancer [4][5] - The funds raised will extend the company's financial visibility until early 2028, allowing for ongoing clinical trials and preparation for potential pivotal trials [6][8] Fundraising Details - The fundraising consists of a private placement for institutional investors and a public offering for retail investors, with TSGH committing to invest at least €70 million [11][14] - The private placement and PrimaryBid offering will close on November 26, 2025, with trading of Transgene shares suspended on that day [6][32] - The net proceeds from the fundraising will be allocated primarily to the myvac® program (approximately 70%), followed by R&D costs (approximately 20%), and general operational expenses [7][8] Financial Position - Prior to the fundraising, Transgene had €11.1 million in cash and a drawing capacity of €8.7 million on its Current Account Advance [9] - Following the fundraising, the company expects to meet its working capital requirements until early 2028, significantly improving its financial stability [10][8] - The Reserved Capital Increase of approximately €39.4 million will be executed at the same price as the private placement, converting debt into equity and strengthening the company's balance sheet [34][36] Expected Milestones - Key milestones for the myvac® platform include follow-up data from ongoing trials in head and neck cancers, with significant data expected in 2026 and 2027 [13] - The company plans to launch a Phase 1 trial in a new indication once financing conditions are met, with preparations for late-stage trials expected to conclude by the end of 2027 [12][13] Shareholder Structure - As of the date of the press release, TSGH holds 68.87% of the company's share capital, and after the fundraising, its stake is expected to decrease slightly to 68.06% [28][29] - The fundraising will result in dilution for existing shareholders, with the shareholding percentage for a shareholder holding 1% of the capital before the fundraising expected to drop to approximately 0.63% post-issuance [27]

Core Insights - Transgene is set to present its proprietary computational tool, VacDesignR®, at the ESMO AI & Digital Oncology 2025 conference, which enhances the design and production of recombinant Modified Vaccinia Ankara (MVA)-based vectors for individualized neoantigen therapeutic vaccines [1][2][5] Group 1: VacDesignR® Tool - VacDesignR® optimizes recombinant plasmid architecture for MVA vectors, improving production reliability and vector quality by minimizing unwanted homologous recombination and intelligently selecting peptide sequences [3] - Future versions of VacDesignR® will integrate AI components to enhance performance and scalability, aligning with Transgene's strategy to expedite production timelines for individualized therapeutic vaccines [4] Group 2: Clinical Development - The individualized immunotherapies developed through the myvac® platform are currently in a Phase I/II clinical trial (NCT04183166), utilizing the VacDesignR® tool for their design [2] - TG4050, the first individualized therapeutic vaccine based on the myvac® platform, is designed to treat HPV-negative head and neck cancers following surgery and adjuvant therapy [4][8] Group 3: Company Overview - Transgene focuses on designing and developing virus-based immunotherapies for cancer treatment, with a portfolio that includes viral vector-based immunotherapeutics [8] - The myvac® platform allows for the creation of personalized immunotherapies that encode patient-specific mutations, utilizing advanced AI technologies [9]

Core Insights - Transgene's TG4050, an individualized neoantigen therapeutic vaccine, shows promising immunogenicity data in preventing cancer relapse, with results to be presented at SITC 2025 [1][2][3] - The company is advancing its clinical trials, with the first immunogenicity data from the ongoing Phase II trial expected in H2 2026 [1][6] - Financial updates indicate a positive trend in research tax credits and a strategic funding plan to support operations until the end of December 2026 [12][14][15] Clinical Development - TG4050 has demonstrated the ability to induce neoantigen-specific cytotoxic CD8+ T-cell responses, which can target and eliminate tumor cells, with effects detectable up to two years post-treatment [3][4] - The ongoing Phase I/II trial evaluates TG4050 as a single agent in the adjuvant treatment of HPV-negative head and neck squamous cell carcinoma (HNSCC) [4][6] - Transgene is exploring efficient regulatory pathways to expedite TG4050's development for operable HNSCC patients [7] Financial Position - For Q3 2025, Transgene reported a research tax credit of €5.8 million, up from €4.8 million in Q3 2024, reflecting ongoing clinical trial progress [12] - As of September 30, 2025, the company had €12.8 million in cash, down from €16.7 million at the end of 2024, with a net cash burn of €28.8 million for the first nine months of 2025 [13] - A new amendment to the account advance agreement with major shareholder TSGH has increased funding to €48 million, allowing the company to sustain operations through December 2026 [14][15] Future Plans - Transgene plans to present additional immunological data profiling the neoantigen-specific T-cell response at the SITC Annual Meeting [2][5] - The company is initiating start-up activities for a potential new Phase I trial in a second indication, aiming to begin once all conditions are met [8]

Core Insights - TG4050 demonstrates the ability to induce neoantigen-specific cytotoxic CD8+ T cell responses, which can target and eliminate tumor cells, potentially reducing the risk of cancer relapse [1][3][4] Company Overview - Transgene is a biotech company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset [9][12] - TG4050 is an individualized therapeutic vaccine based on the myvac® platform, designed to stimulate the immune system to recognize and destroy tumor cells [10][12] Clinical Development - TG4050 is currently being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers, with the first immunogenicity data from the Phase II part expected in the second half of 2026 [14] - The trial includes a randomized study design, assessing the treatment benefits of TG4050 in patients at risk of relapse [14] Immunological Data - New immunological data presented at the SITC Annual Meeting confirm TG4050's mechanism of action and its potential for sustained prevention of cancer relapses [4][5] - CD8+ T cells induced by TG4050 exhibit an effector phenotype and persist for up to two years post-treatment, indicating long-term immune response capabilities [8][5] Collaboration and Technology - Transgene collaborates with NEC Corporation, leveraging NEC's AI-driven platform to enhance the development of individualized neoantigen therapeutic vaccines [5][12] - NEC's Neoantigen Prediction System utilizes advanced AI to identify and select the most immunogenic sequences for the vaccine [15][12]

Core Insights - BT-001, in combination with pembrolizumab, demonstrates good tolerability and sustained antitumoral activity in both injected and non-injected lesions, supporting further development in solid tumors to enhance cancer immunotherapy responses [1][5][6] Clinical Results - Intra-tumoral injection of BT-001 combined with KEYTRUDA® (pembrolizumab) showed positive local, abscopal, and sustained antitumoral activity [2] - Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions across three melanoma patients and one sarcoma patient, with four patients experiencing shrinkage in non-injected lesions [3] - Long-lasting partial responses were noted in a melanoma patient resistant to anti-PD-1/anti-CTLA-4 therapy and a heavily pre-treated, PD-L1 negative leiomyosarcoma patient [4] Mechanism of Action - The immune-mediated tumor shrinkages align with the hypothesis that BT-001, in combination with pembrolizumab, can convert "cold" tumors into immunologically active ones [5] - BT-001 is designed to induce a strong anti-tumor response by expressing GM-CSF and an anti-CTLA-4 antibody, potentially expanding treatment options with a favorable safety profile [6][11] Company Statements - Transgene and BioInvent are co-developing BT-001, which utilizes Transgene's Invir.IO® platform to enhance replication selectivity in tumor cells and express an anti-CTLA-4 antibody [6][12] - The companies aim to continue exploring the safety and efficacy of BT-001, with ongoing clinical trials evaluating its use alone and in combination with pembrolizumab [11][12]

Core Insights - BT-001, in combination with pembrolizumab, demonstrates good tolerability and sustained antitumoral activity in both injected and non-injected lesions, supporting further development in solid tumors to enhance cancer immunotherapy responses [1][5][6] Clinical Results - Intra-tumoral injection of BT-001 combined with KEYTRUDA® (pembrolizumab) showed positive local, abscopal, and sustained antitumoral activity [2] - Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions across three melanoma patients and one sarcoma patient, with four patients experiencing shrinkage in non-injected lesions [3] - Long-lasting partial responses were noted in a melanoma patient resistant to anti-PD-1/anti-CTLA-4 therapy and a heavily pre-treated, PD-L1 negative leiomyosarcoma patient [4] Mechanism of Action - The immune-mediated tumor shrinkages suggest that BT-001, in combination with pembrolizumab, can convert "cold" tumors into immunologically active ones, enhancing responses to cancer immunotherapies [5][6] Expert Commentary - Experts emphasize the urgent need for new treatment approaches for cancer patients who do not respond to existing therapies, highlighting BT-001's potential to induce a strong local immune response and expand treatment options with a favorable safety profile [6][7] Development Plans - Transgene and BioInvent are co-developing BT-001, which is designed to elicit a strong anti-tumoral response in solid tumors, and will continue to explore its safety and efficacy in clinical settings [6][10]

Core Insights - Transgene and BioInvent are presenting promising clinical results for BT-001, an oncolytic virus, in combination with pembrolizumab at the ESMO Annual Meeting [1][3][4] - The Phase I study indicates that BT-001 is well tolerated and shows anti-tumor activity in patients with advanced refractory tumors [5][7] Company Overview - Transgene is a biotech company focused on developing virus-based immunotherapies for cancer treatment, with BT-001 being one of its key assets [8][10] - BioInvent specializes in discovering and developing novel immune-modulatory antibodies for cancer therapy, utilizing its proprietary F.I.R.S.T.™ technology platform [10][11] Clinical Study Details - The Phase I/IIa study (NCT04725331) is a multicenter, open-label, dose-escalation trial evaluating BT-001 both as a single agent and in combination with pembrolizumab [5][4] - The study has shown that BT-001 can convert "cold" tumors into "hot" tumors, enhancing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment [5][7] Treatment Efficacy - In the study, tumor shrinkage was observed in both injected and non-injected lesions, indicating a systemic effect [7] - Notably, two patients with resistant melanoma and heavily pretreated leiomyosarcoma exhibited partial responses lasting 6 and 16 months, respectively [7]

Company Focus - Transgene's Scientific Director, Maurizio, is leading the development of personalized cancer vaccines using artificial intelligence [1] - Transgene aims to transform medical challenges into innovation opportunities, specifically in oncology [1] - The company's work spans gene therapy, virology, and immunology [1] Scientific Leadership - Maurizio's work is driven by the belief that science can change the world [1] - He combines scientific rigor with a passion for improving patient lives [1]

Core Insights - Transgene will present a detailed analysis of the neoantigen-specific T cell response from the Phase I trial of its individualized therapeutic cancer vaccine, TG4050, at the upcoming SITC Annual Meeting [1][3] - TG4050 is being developed for solid tumors, specifically targeting HPV-negative head and neck cancers, utilizing Transgene's myvac® technology and NEC's AI capabilities [3][5] - The Phase I trial results showed that all patients receiving TG4050 remained disease-free after a minimum of 2-year follow-up, contrasting with a 19% relapse rate in the observational arm [4] Company Overview - Transgene is a biotechnology company focused on developing targeted immunotherapies for cancer treatment, with a portfolio of viral vector-based immunotherapeutics [5] - TG4050 is the lead asset of the company, representing the first individualized therapeutic vaccine based on the myvac® platform, demonstrating proof of principle in head and neck cancer treatment [5][6] - The company is also advancing other viral vector-based assets, including BT-001, which is in clinical development [5] Clinical Development - TG4050 is currently being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers [3] - A Phase II extension of the trial is ongoing, with patient enrollment currently in progress [4]

Core Insights - Transgene reported positive Phase I data for TG4050, showing 100% disease-free survival after a median follow-up of 30 months in operable head and neck squamous cell carcinoma (HNSCC) patients [3][4][8] - The company is progressing into Phase II trials for TG4050, with initial patient screening completed and randomization expected by the end of 2025 [6][7] - Transgene's financial position is stable, with funding secured until the end of December 2026, allowing for continued development of its lead asset [22][23] Financial Performance - Operating income for the first half of 2025 was €4.6 million, an increase from €3.4 million in the same period of 2024 [20] - Research and development expenses rose to €17.9 million from €15.4 million year-over-year, while general and administrative expenses decreased to €3.8 million from €4.6 million [20] - As of June 30, 2025, Transgene had €16.8 million in cash, slightly up from €16.7 million at the end of 2024, with a cash burn of €18.8 million in the first half of 2025 [21] Clinical Development - TG4050 is the first candidate from Transgene's myvac® platform, which aims to provide individualized therapeutic cancer vaccines [4][26] - The company is preparing to initiate a new Phase I trial for a second indication, expanding the myvac® platform's potential [9] - Additional immunological data from the Phase I study will be presented in Q4 2025, with first immunogenicity data from the Phase II trial expected in H2 2026 [5][8] Governance and Leadership - Simone Steiner joined Transgene as Chief Technical Officer in April 2025, bringing expertise in CAR-T cell therapies to enhance the manufacturing of myvac®-based immunotherapies [16] - Emmanuelle Quilès was appointed as an independent Board member in July 2025, contributing 25 years of experience in the pharmaceutical industry [17] Other Assets and Collaborations - Transgene is also developing BT-001, an oncolytic virus, with updated data to be presented at ESMO 2025 [10][11] - The company is evaluating TG4001 for HPV-positive cancers and TG6050 for advanced non-small cell lung cancer, with ongoing assessments of their clinical development paths [13][14][15]