Preclinical-stage biotech company explores digital asset treasury opportunities to enhance capital efficiency while maintaining core focus on immunotherapy innovationLA PALMA, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- Liminatus Pharma, Inc. (NASDAQ: LIMN), a preclinical-stage biopharmaceutical company dedicated to the development of targeted cancer immunotherapies, today announced that it has initiated a strategic review to evaluate the potential inclusion of regulated digital asset strategies as part of it ...

Core Viewpoint - BioNTech SE will announce its financial results for the second quarter of 2025 on August 4, 2025, and will host a conference call and webcast for stakeholders to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The financial results for Q2 2025 will be disclosed on August 4, 2025 [1]. - A conference call and webcast will take place at 8:00 a.m. EDT (2:00 p.m. CEST) on the same day [1]. Group 2: Accessing the Conference Call - Participants can register for the live conference call via a provided link, with dial-in numbers and a PIN sent post-registration [2]. - It is recommended to register at least one day in advance for the call [2]. - The slide presentation and audio of the webcast will be accessible through a specified link [2]. Group 3: Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [4]. - The company utilizes a variety of computational discovery and therapeutic modalities for rapid biopharmaceutical development [4]. - BioNTech's oncology product candidates include mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4]. - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [4]. - BioNTech has established collaborations with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech [4].

Core Points - BioNTech SE announced the resignation of Ryan Richardson as Chief Strategy Officer effective September 30, 2025, to pursue new professional opportunities [1] - Richardson joined BioNTech in 2018 and has been instrumental in raising over USD 1 billion through various financing activities, including the Initial Public Offering on Nasdaq [2] - His contributions include building Global Strategy and Corporate Development functions, enhancing Capital Markets and Investor Relations, and serving on the Board of Directors of InstaDeep Ltd. since its acquisition in 2023 [2] Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and other serious diseases [4] - The company has a diversified oncology product portfolio, including mRNA cancer immunotherapies, immunomodulators, and targeted therapies such as antibody-drug conjugates and CAR T cell therapies [4] - BioNTech collaborates with various global pharmaceutical companies, including Bristol Myers Squibb, Pfizer, and Genentech, to advance its research and development efforts [4]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were approximately €183 million, a slight decrease from €188 million in Q1 2024, reflecting expected seasonality in the COVID-19 vaccine market [26] - Research and development expenses increased to €526 million from €508 million in the prior year, driven by late-stage clinical studies [26] - The net loss for Q1 2025 was €416 million, compared to a net loss of €350 million in the same period last year, with a basic and diluted loss per share of €1.73 versus €1.31 [27][28] Business Line Data and Key Metrics Changes - The oncology segment is advancing with multiple clinical trials, including BNT327, which is being developed for various cancer types, including triple-negative breast cancer and small cell lung cancer [14][15] - The COVID-19 vaccine franchise remains a significant revenue driver, with preparations for a variant-adapted vaccine for the upcoming season [8] Market Data and Key Metrics Changes - The addressable market for the second-line endometrial cancer treatment is estimated at around 10,000 patients in the US and Europe, indicating a sizable opportunity [41] - The company anticipates stable vaccination rates and market shares for its COVID-19 vaccine, with revenue guidance for 2025 expected to be between €1.7 billion and €2.2 billion [30][31] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with a focus on oncology, particularly through the development of BNT327 and mRNA cancer immunotherapies [28][36] - There is a strong emphasis on combination therapies to improve treatment outcomes across various cancer types, with ongoing investments in clinical development and commercialization capabilities [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their oncology pipeline to establish new standards of care and improve patient outcomes [12][25] - The company is closely monitoring regulatory changes and public sentiment regarding COVID-19 vaccines, which could impact future revenues [31][56] Other Important Information - The company announced a new Chief Financial Officer, Ramon Sapater, who will take over in July 2025, as current CFO Jens Holstein prepares for retirement [10][34] - The company is diversifying its manufacturing supply base for BNT323, currently reliant on a China-based CDMO, to mitigate risks associated with tariffs [41][44] Q&A Session Summary Question: What is the addressable population for endometrial cancer? - The estimated second-line market in endometrial cancer is about 10,000 patients in the US and Europe [41] Question: How do you see the NSCLC market evolving in five years? - Both bispecifics and ADCs will play a role in the NSCLC market, with the expectation that clinical benefit thresholds will evolve over time [50][72] Question: What impact do you anticipate from the CDC's upcoming vote on COVID boosters? - The company expects the market is already oriented towards a risk-based vaccination approach, with a base scenario of around 20% vaccination rates continuing [55] Question: Can you elaborate on the Phase II and Phase III trial timelines for BNT327? - The Phase II portion of the Rosetta trial will be completed later this year, with data to inform the Phase III portion [87] Question: How do you plan to manage toxicity observed in initial data for BNT327? - The stomatitis rate in combination with TROP-two ADC was comparable to that observed with BNT325 alone, indicating no additional additive toxicity [94]

Core Insights - BioNTech will present data from its oncology pipeline at the AACR Annual Meeting, highlighting advancements in mRNA cancer immunotherapies, immunomodulators, and targeted therapies [1][4] - The company aims to establish a future standard of care for advanced cancers through combination therapies that enhance anti-tumor activity [2] Oncology Pipeline Overview - BioNTech has a diversified oncology portfolio that includes over 20 active Phase 2 and Phase 3 clinical trials, focusing on mRNA cancer immunotherapies and the next-generation immunomodulator BNT327 [4] - The company is progressing towards becoming a multi-product oncology company with multiple data readouts expected in 2025 and 2026 [4] Key Presentations at AACR 2025 - Preclinical data for BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, will be presented, showing superior anti-tumor activity compared to single treatments [7] - Early clinical data from the Phase 1/2 trial of BNT327 in combination with TROP2-targeting ADC BNT325/DB-1305 will be shared, including safety and efficacy results [7] - Data from the Phase 1 trial of mRNA cancer immunotherapy candidate BNT116 in combination with anti-PD1 cemiplimab will be presented, focusing on frail patients with advanced non-small cell lung cancer [7] Collaboration and Development - BioNTech collaborates with Duality Biologics for the development of ADCs and has established partnerships with various pharmaceutical companies to enhance its oncology pipeline [9][15]