Core Insights - Transgene announced a 30-minute oral presentation on TG4050, an Individualized Neoantigen Therapeutic Vaccine, at the World Vaccine Congress from March 31 to April 2, 2026, in Washington, D.C. [1] - The presentation will focus on findings from the Phase 1 part of the ongoing Phase 1/2 trial in head and neck cancer, discussing the potential of individualized neoantigen vaccines to transform early-stage cancer treatment [2][3] Company Overview - Transgene is a biotechnology company specializing in the design and development of virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset [5] - The company utilizes the myvac® platform to create individualized therapeutic vaccines tailored to each patient's tumor characteristics, supported by AI technology from its partner NEC [7] Clinical Trial Insights - In the Phase 1 trial, patients with resected head and neck cancer treated with TG4050 developed new immune responses targeting specific neoantigens, with all treated patients remaining tumor-free two years post-treatment [3] - Transgene aims to continue generating clinical data for head and neck cancer and other indications to prevent cancer relapse in at-risk patients [4]

Core Insights - Transgene is advancing its individualized neoantigen therapeutic vaccine, TG4050, which has shown durable clinical outcomes in head and neck squamous cell carcinoma (HNSCC) and potential to prevent cancer relapse [1][4][6] - The company has sufficient financial resources to support its operations until early 2028, following a successful fundraising of approximately €105 million and the conversion of €39 million debt into shares [21][26] - The randomized Phase 2 part of the clinical trial for TG4050 is nearing completion, with the primary endpoint being two-year disease-free survival [10][11] Clinical Development - TG4050 has demonstrated a 100% disease-free survival rate after more than two years of follow-up in the Phase 1 trial, meeting all trial endpoints [7][8] - A new Phase 1 trial for a second indication in operable solid tumors is planned to start in 2026, reflecting the strategy to expand the clinical evaluation of the myvac® platform [2][12] - Positive results from the Phase 1 trial of BT-001 support further clinical development, showing antitumoral activity in patients with advanced refractory tumors [15][17] Financial Performance - Operating revenue for 2025 was €7.2 million, an increase from €6.4 million in 2024, primarily driven by research tax credits [22][43] - The company reported a net loss of €37.5 million in 2025, compared to a net loss of €34.0 million in 2024, with a net cash burn of €38.2 million [26][48][50] - Cash, cash equivalents, and other financial assets totaled €111.9 million as of December 31, 2025, significantly up from €16.7 million at the end of 2024 [26][49] Strategic Initiatives - Transgene is optimizing its manufacturing processes to prepare for potential pivotal clinical trials [13] - The company is leveraging its proprietary VacDesignR® computational tool to enhance the quality and reliability of its vaccine production [14] - Recent leadership additions aim to accelerate the development of the myvac® platform, with new appointments in key executive roles [19][20]

Core Viewpoint - Transgene, a biotech company specializing in virus-based immunotherapies for cancer treatment, has announced its financial reporting and annual shareholders' meeting dates for 2026 [1]. Financial Reporting Schedule - The company will release its 2025 Fiscal Year Results on March 24, 2026 [1]. - The First Quarter 2026 Financial Results will be announced on April 29, 2026 [1]. - The Annual Shareholders' Meeting is scheduled for May 13, 2026 [1]. - The First Half 2026 Financial Results will be disclosed on September 24, 2026 [1]. - The Third Quarter 2026 Financial Results will be reported on November 9, 2026 [1]. Company Overview - Transgene focuses on designing and developing targeted immunotherapies for cancer, with a portfolio of viral vector-based immunotherapeutics [2]. - The lead asset, TG4050, is the first individualized therapeutic vaccine based on the myvac® platform, showing proof of principle in treating head and neck cancers [2]. - Other assets include BT-001, an oncolytic virus in clinical development, and ongoing innovative discovery and preclinical work for novel immunotherapies [2]. Technological Innovation - The myvac® platform enables precision medicine through a tailored virus-based immunotherapy that incorporates patient-specific mutations identified by Artificial Intelligence in collaboration with NEC [3].

Core Viewpoint - Transgene has strengthened its Scientific Advisory Board by appointing two prominent scientific advisors, Prof. Antoine Italiano and Prof. Ignacio Melero, to enhance its leadership in cancer immunotherapy development [1][2]. Group 1: Company Overview - Transgene is a biotechnology company focused on designing and developing virus-based immunotherapies for cancer treatment, with a clinical-stage portfolio that includes the myvac® platform for individualized neoantigen therapeutic vaccines [10][11]. - The company’s lead asset, TG4050, has shown proof of principle in patients for the adjuvant treatment of head and neck cancers, and it is also developing other viral vector-based assets like BT-001 [10]. Group 2: Scientific Advisors - Prof. Antoine Italiano is a leading medical oncologist with expertise in early drug development and precision medicine, serving as Head of the Department of Medicine at Institut Bergonié and leading the Precision Medicine program at Gustave Roussy [2][3]. - He has been the Principal Investigator for over 50 Phase I trials and more than 40 Phase II and III clinical trials, focusing on immuno-oncology and targeted therapies [3][4]. - Prof. Ignacio Melero is a professor of immunology at the University of Navarra and co-director of the Department of Immunology and Immunotherapy, recognized for his work in cancer immunotherapy and immunostimulatory monoclonal antibodies [5][6]. - He has led over 40 clinical trials in immunotherapy and has published more than 350 scientific articles, receiving an ERC Advanced Grant for his research on mRNA-based immunotherapies [7][8].

Core Insights - TG4050 demonstrates strong potential as an individualized cancer immunotherapy, showing 100% two-year disease-free survival in patients with operable head and neck cancers [3][5][8] Clinical Trial Results - The Phase I/II trial of TG4050 involved patients with HPV-negative head and neck squamous cell carcinoma (HNSCC), where one-third of patients typically experience recurrence within two years post-surgery [3] - Half of the participants received TG4050 immediately after primary adjuvant treatment, while the other half received it at the time of disease recurrence [4][16] - The trial results indicate that TG4050 can prevent cancer relapses when used as monotherapy in high-risk, resected, locally advanced HPV-negative HNSCC patients [5] Immunogenicity and T-cell Responses - TG4050 induced neoantigen-specific T-cell responses in 73% of evaluable patients, with these responses being durable for up to one year post-treatment [6][7] - The vaccine was well-tolerated, showing no unexpected safety signals, reinforcing its potential for further development [5][8] Publication and Transparency - The results of the Phase I trial have been published on medRxiv, emphasizing the company's commitment to transparency and scientific rigor [2][8] - The findings are currently under evaluation for publication in a peer-reviewed journal [2] Future Developments - TG4050 is undergoing further evaluation in a randomized Phase I/II clinical trial (NCT04183166), with first immunogenicity data from the Phase II part expected in the second half of 2026 [7][16]

Core Points - Transgene has requested the suspension of trading of its shares on Euronext Paris pending the publication of the results of its capital increase, with trading set to resume on 27 November 2025 [1] Company Overview - Transgene is a biotechnology company focused on developing targeted immunotherapies for cancer treatment, with a portfolio of viral vector-based immunotherapeutics [2] - The company's lead asset is TG4050, an individualized therapeutic vaccine based on the myvac® platform, which has shown proof of principle in treating head and neck cancers [2] - Transgene is also developing other viral vector-based assets, including BT-001, an oncolytic virus in clinical development, and is engaged in innovative discovery and preclinical work for novel viral vector-based modalities [2] Technology and Innovation - The myvac® platform allows for the creation of personalized virus-based immunotherapies that encode patient-specific mutations identified through advanced AI technologies [3] - Transgene's proprietary Invir.IO® platform is aimed at designing a new generation of multifunctional oncolytic viruses, leveraging the company's expertise in viral vector engineering [4]

Core Points - Transgene successfully raised approximately €105 million through a fundraising initiative involving private placements and retail offerings at a price of €1.02 per share [1][6][10] - The funds will primarily support the development of the myvac® platform, which focuses on individualized therapeutic vaccines for cancer treatment [4][5][7] - The fundraising included participation from specialized healthcare investors and existing shareholders, indicating strong institutional interest [2][21] Fundraising Details - The fundraising consisted of a private placement and a public offering via the PrimaryBid platform, with a total of 141,433,349 new ordinary shares issued, representing 106.5% of the company's current share capital [9][10] - The subscription price of €1.02 per share reflects a 25% discount compared to the closing price prior to the fundraising [10] - A reserved capital increase of €39,262,015.44 was also conducted for TSGH, utilizing amounts advanced under a current account advance agreement [3][12] Use of Proceeds - Approximately 70% of the net proceeds will be allocated to accelerate the myvac® program, including ongoing Phase 2 trials and the launch of new indications [7][5] - About 20% will be directed towards R&D costs related to the myvac® program and other clinical trials [7] - The remaining funds will cover general administrative expenses and recurring cash consumption [7] Expected Milestones - Key milestones include the completion of the ongoing Phase 2 trial in head and neck cancers, with results anticipated by late 2027 or early 2028 [4][15] - The company plans to launch a Phase 1 trial in a new indication and prepare for pivotal trials by the end of 2027 [15][4] Share Capital and Ownership Structure - Post-fundraising, the company's share capital will amount to €82,256,012.70, divided into 274,186,709 ordinary shares [18] - TSGH will hold 78.29% of the capital, while SITAM Belgium will hold 3.55%, with other shareholders comprising 18.16% [18][21] Trading and Regulatory Information - Trading of Transgene's shares on Euronext Paris was suspended during the fundraising and is set to resume on November 27, 2025 [23][24] - The new shares will be fungible with existing shares and will carry the same rights [25]

Core Points - Transgene has requested a suspension of trading for its shares on Euronext Paris starting November 26, 2025, pending the announcement of its capital increase results [1] - Trading is expected to resume on November 27, 2025, at market opening [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment, with a portfolio that includes several viral vector-based immunotherapies in clinical development [2] - The lead candidate, TG4050, is the first individualized treatment from the myvac® platform, showing clinical proof of concept in patients with head and neck cancer [2] - Other candidates in development include BT-001, an oncolytic virus based on the patented invir.IO® platform [2] Technology and Innovation - The myvac® platform integrates tumor mutations identified through artificial intelligence into a viral vector, marking a step into precision medicine [3] - The invir.IO® platform allows for the design of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [3]

Core Points - Transgene has requested a suspension of trading for its shares on Euronext Paris pending the publication of results from its capital increase [1] - Trading is expected to resume on November 27, 2025, at the market opening [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment [2] - The company's lead candidate, TG4050, is an individualized treatment that has shown clinical proof of concept in patients with head and neck cancer [2] - Transgene is also developing other candidates, including BT-001, which is based on a patented oncolytic virus [2] Technology Platforms - The myvac® platform allows for patient-specific immunotherapy by integrating tumor mutations identified through artificial intelligence [3] - The invir.IO® platform enables the design of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [3]

Core Viewpoint - Transgene has requested a suspension of trading for its shares on Euronext Paris pending the announcement of its capital increase results, with trading expected to resume on November 27, 2025 [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment, with a portfolio that includes several viral vector-based immunotherapies currently in clinical development [3] - The lead candidate, TG4050, is the first individualized treatment from the myvac® platform, showing clinical proof of concept in patients with head and neck cancer [3] - Other candidates in development include BT-001, an oncolytic virus based on the patented invir.IO® platform [3] Technology and Innovation - The myvac® platform integrates tumor mutations identified through artificial intelligence into a viral vector, marking a step into precision medicine [4] - The invir.IO® platform allows for the design of a new generation of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [4]