Core Insights - BioNTech will present clinical trial data for its oncology pipeline at the ESMO Congress 2024 in Barcelona from September 13-17, 2024, focusing on mRNA-based cancer vaccines, immunomodulators, and targeted therapies [1][4] Clinical Trial Updates - The company will showcase updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, in various cancer indications [3][4] - Preliminary data from ongoing trials for BNT113, an mRNA immunotherapy for HPV16-driven cancers, will demonstrate immunogenicity and antitumor activity in heavily pre-treated patients [3][4] - Data from a randomized Phase 2 trial of BNT316/ONC-392 in combination with pembrolizumab for platinum-resistant recurrent ovarian cancer will be presented in a late-breaking session [3][4] - Follow-up data on BNT211, a CAR-T cell therapy for CLDN6+ solid tumors, will show signs of antitumor activity and increased persistence of CAR-T cells when combined with an mRNA vaccine [3][4] Pipeline Overview - BioNTech has a diversified oncology pipeline with over 32 clinical trials, including eight in advanced Phase 2 and two in pivotal Phase 3 trials, aiming for ten or more registrational trials by the end of 2024 [4][7] - The company is developing a range of therapies, including mRNA-based vaccines, CAR-T cells, bispecific antibodies, and antibody-drug conjugates [7]

Delhi, Aug. 25, 2024 (GLOBE NEWSWIRE) -- A significant breakthrough in cancer treatment was achieved with the initiation of the first mRNA lung cancer vaccine trials globally. This innovative project, featuring BioNTech's BNT116, heralds the dawn of a transformative period in cancer therapy domain, with the potential to fundamentally change our strategies for cancer therapy. BNT116 is specifically engineered to combat nonsmall cell lung cancer (NSCLC) and signifies a major progression in the field of person ...

Core Viewpoint - The UK has initiated a clinical trial for a new experimental lung cancer vaccine, BNT116, developed by BioNTech, which utilizes mRNA technology similar to that used in COVID-19 vaccines [1][5]. Group 1: Vaccine Details - The vaccine is designed to train five billion immune cells to target different parts of the tumor, potentially leading to a more effective immune response against lung cancer [1]. - BNT116 is reported to be more precisely targeted than traditional chemotherapy, minimizing collateral damage to healthy cells and reducing side effects [2][5]. - The trial will involve approximately 130 patients with non-small cell lung cancer across six hospitals in the UK [3][7]. Group 2: Clinical Trial Insights - This is the first human trial for the BioNTech vaccine, with a focus on assessing major side effects before larger studies can confirm clinical effectiveness [5]. - Participants will receive multiple doses over a 12-month period to continuously boost their immune response [5]. - The trial includes patients at various stages of lung cancer, including those who have not yet undergone surgery or radiotherapy, allowing for a broader understanding of the vaccine's potential [7]. Group 3: Industry Implications - The development of this vaccine is part of a broader effort to find new treatments for lung cancer, which has a high mortality rate, with 1.8 million deaths globally each year [8]. - The NHS is taking a leading role in trialing cancer vaccines, with the potential for these vaccines to revolutionize cancer treatment by preventing recurrence after initial therapies [9]. - There is an expectation of increased participation in clinical trials for cancer treatments in the coming years, providing hope for patients [10].

Investment Overview - BioNTech SE reported Q2 2024 earnings, showing a significant decline in revenues from its COVID-19 vaccine Comirnaty, with revenues dropping from $21.6 billion in 2021 to $4.2 billion in 2023, and only $345 million in the first half of 2024 [2][3] - The company reported Q2 revenues of approximately $140 million, leading to an operating loss of around $(1.05 billion) and a net loss of $(881 million) [2][3] - BioNTech reaffirmed its 2024 revenue guidance of approximately $2.72 billion to $3.4 billion, with R&D expenses expected to be between $2.6 billion and $2.83 billion [2][3] Comirnaty and Market Dynamics - Comirnaty remains BioNTech's sole commercial product, with revenues primarily generated through government contracts and a new private market for endemic COVID vaccines [3][4] - The FDA has specified a target strain for COVID vaccines, and BioNTech is preparing to launch a variant-adapted vaccine in over 40 countries [4][3] - The potential market for COVID vaccines could reach approximately $10 billion in the US and EU combined, with BioNTech potentially capturing a 50% market share [4][3] Oncology Pipeline - BioNTech is refocusing on oncology, with a diverse pipeline that includes personalized cancer vaccines and immuno-oncology agents [5][6] - The company has ongoing Phase 2 studies for its cancer vaccine candidates, with positive data reported for BNT111 in melanoma [6][5] - Despite the promising pipeline, BioNTech faces intense competition from established players like Moderna and Merck, making it challenging to carve out a niche in the oncology market [6][5] Future Outlook - BioNTech is not expected to report any Phase 3 data readouts in 2024, with potential drug launches anticipated in 2026 [7] - The company's current valuation of nearly $20 billion may not be sustainable given the projected revenues of less than $3.5 billion and the absence of profits [7][8] - The oncology pipeline holds promise, but there are concerns about the company's ability to deliver unique and competitive products in a crowded market [8][7]

Financial Data and Key Metrics Changes - Total revenues for Q2 2024 reached approximately €129 million, down from approximately €168 million in Q2 2023, reflecting a seasonal decline in COVID-19 vaccine demand [35] - Cost of sales decreased to approximately €60 million in Q2 2024 from approximately €163 million in the prior-year period [35] - Research and development expenses increased to approximately €585 million in Q2 2024 from approximately €373 million in the prior-year period, with 90% of R&D spend focused on non-COVID initiatives [36] - Net loss for Q2 2024 was approximately €808 million, compared to a net loss of about €190 million in the prior-year period, resulting in a loss per share of €3.36 [37] Business Line Data and Key Metrics Changes - The COVID-19 vaccine franchise continues to evolve with the launch of a new variant-adapted vaccine, with expectations for additional approvals [4][8] - Significant progress in the oncology pipeline, particularly with the BNT111 melanoma vaccine, which met its primary endpoint in a Phase 2 trial [5][18] - The company is expanding its oncology portfolio with new combination therapies and trials, including the BNT327 bispecific antibody [27][30] Market Data and Key Metrics Changes - The JN.1 lineage has become the predominant COVID-19 variant, leading to updates in vaccine formulations recommended by regulatory authorities [7][8] - The company anticipates a significant portion of COVID-19 vaccine demand to come from outside the United States, with new private markets emerging in regions like the UK and Japan [43] Company Strategy and Development Direction - The company aims to establish a sustainable vaccine ecosystem in Africa through partnerships, including a commitment of up to US$145 million from CEPI for mRNA vaccine manufacturing in Rwanda [6] - The oncology strategy focuses on a technology-agnostic approach, leveraging multiple modalities to enhance treatment efficacy and patient outcomes [10][12] - The company plans to initiate multiple combination trials in solid tumor indications over the next 12 months, emphasizing the development of novel therapies [45] Management's Comments on Operating Environment and Future Outlook - Management expects Q2 2024 to be the low point for COVID-19 vaccine uptake, with a significant revenue increase anticipated in Q4 following expected FDA approvals [35][39] - The company maintains a strong cash position of approximately €18.5 billion, providing strategic flexibility for long-term growth investments [38] - Management reiterated the expectation of a net loss for the 2024 financial year while continuing to invest in proprietary assets and technologies [39] Other Important Information - The company is scaling up manufacturing capabilities for both off-the-shelf and personalized mRNA vaccines, with a pilot facility being built in Mainz, Germany [26] - Upcoming presentations at major conferences will provide updates on key assets, including BNT113 and BNT327, with a focus on safety and efficacy data [34] Q&A Session Summary Question: Potential launches in 2026 - Management highlighted BNT323 and BNT122 as potential candidates for accelerated approval and launch in 2026, pending further FDA discussions [48][49] Question: Historical controls for BNT111 - Management indicated that BNT111 is being compared against standard-of-care treatments for melanoma, with a focus on achieving clinically meaningful benefits [51][52] Question: Phase 3 COVID Flu combo data - Management expects safety and efficacy data by the end of the year, which will inform potential submission for the 2025/2026 season [54][55] Question: Internal oncology program benefits - Management noted multiple programs in non-small-cell lung cancer that could benefit from recent data, with a focus on portfolio strategy [58][59] Question: Margin progression - Management discussed the current high margins from the COVID-19 partnership with Pfizer and indicated that oncology margins will align more closely with industry standards as the pipeline progresses [63][66]

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Financial Performance - Revenues for Q2 2024 were €128.7 million, a decrease of 23.2% compared to €167.7 million in Q2 2023[5] - The operating loss for Q2 2024 was €966.2 million, compared to a loss of €563.3 million in Q2 2023[5] - The net loss for the period in Q2 2024 was €807.8 million, compared to a loss of €190.4 million in Q2 2023[7] - Total revenues for the three months ended June 30, 2024, were €128.7 million, down from €167.7 million in the same period of 2023, with COVID-19 vaccine revenues at €71.9 million compared to €158.2 million[25] - For the six months ended June 30, 2024, total revenues were €316.3 million, significantly lower than €1,444.7 million in the same period of 2023[25] - The company reported a basic loss per share of €3.36 for Q2 2024, compared to a loss of €0.79 per share in Q2 2023[5] - The company experienced a comprehensive loss of €915.4 million for Q2 2024, compared to a loss of €182.2 million in Q2 2023[7] Research and Development - Research and development expenses increased significantly to €584.6 million in Q2 2024, up 56.5% from €373.4 million in Q2 2023[5] - The company is focusing on expanding its research and development efforts, as indicated by the significant increase in R&D expenses[5] - BioNTech's research and development efforts continue to focus on mRNA vaccines and therapeutics, cell and gene therapies, and other innovative approaches to address unmet medical needs[15] - Research and development expenses increased by €211.2 million (57%) to €584.6 million for the three months and by €384.7 million (54%) to €1,092.1 million for the six months, driven by clinical studies and increased headcount[29] Cash and Assets - Total assets decreased to €22,237.9 million as of June 30, 2024, down from €23,006.3 million at the end of 2023[9] - Cash and cash equivalents were €10,376.7 million as of June 30, 2024, a decrease from €11,663.7 million at the end of 2023[9] - Cash and cash equivalents as of June 30, 2024, were €10,376.7 million, down from €14,166.6 million at the end of June 2023[13] - The company reported a net cash inflow from operating activities of €1,627.2 million for the three months ended June 30, 2024, compared to €4,386.7 million in the same period of 2023[13] Equity and Liabilities - Total equity decreased to €19,072.3 million as of June 30, 2024, down from €20,245.9 million at the end of 2023[9] - The total carrying amount of financial assets measured at fair value was €5,411.0 million, with money market funds contributing €5,409.7 million[46] - As of June 30, 2024, the total financial liabilities not measured at fair value amounted to €1,088.4 million, including lease liabilities of €254.6 million and trade payables of €881.5 million[46] - Total provisions amounted to €372.9 million, up from €278.1 million as of December 31, 2023, representing a 34% increase[58] Legal Matters - The company is involved in multiple ongoing intellectual property disputes, with significant uncertainties regarding potential liabilities[62] - The Düsseldorf Regional Court has suspended infringement rulings related to several patents pending validity decisions, indicating ongoing legal complexities[68] - The Federal Patent Court of Germany nullified the EP'122 Patent, with an appeal currently pending from CureVac[70] - BioNTech is currently involved in multiple patent litigations, including cases filed by Moderna in the US, UK, Netherlands, Ireland, and Belgium, with outcomes remaining uncertain[85] COVID-19 Vaccine Developments - BioNTech's COVID-19 vaccine, Comirnaty, has been authorized or approved in over 180 countries, with more than 4.8 billion doses shipped globally as of December 2023[104] - The company is preparing for the commercial launch of a SARS-CoV-2 variant-adapted vaccine for the 2024/2025 fall and winter season, pending regulatory approval[106] - The Omicron JN.1 sublineages account for the majority of COVID-19 cases globally, necessitating updated vaccines for better protection against symptomatic and severe disease[107] - The European Medicines Agency recommended marketing authorization for the Omicron JN.1-adapted monovalent COVID-19 vaccine for individuals 6 months and older[109] Corporate Strategy and Partnerships - BioNTech's corporate strategy includes strengthening its clinical pipeline and technology platforms through strategic partnerships and acquisitions[100] - The company is actively pursuing market expansion and new product development to enhance its portfolio and address global health challenges[15] - BioNTech's management emphasizes the importance of collaboration with partners, such as Pfizer, to optimize revenue sharing and enhance product offerings[19] Clinical Trials and Product Pipeline - The company has a robust and diversified product pipeline across oncology and infectious diseases, leveraging multiple technology platforms[98] - BioNTech is developing BNT211 for germ cell tumors, with a pivotal Phase 2 trial expected to start in 2025 based on encouraging Phase 1 data[138] - The ongoing Phase 2 trial of autogene cevumeran (BNT122) in adjuvant colorectal cancer is expected to enroll about 200 patients, with primary endpoint being disease-free survival (DFS)[126] - A randomized Phase 2 trial for autogene cevumeran in pancreatic ductal adenocarcinoma (PDAC) is recruiting 260 patients, with DFS as the primary endpoint[129]

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA") Reiterates guidance for total revenues in the range of €2.5-3.1 billion Reports second qua ...

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA") Reiterates guidance for total revenues in the range of €2.5-3.1 billion Reports second qua ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...