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Yahoo
14-08-2025
- Business
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Alligator Bioscience to Host Virtual R&D Day on 19 August 2025
LUND, SE / / August 14, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announces that it will host a virtual R&D Day on Tuesday, 19 August 2025 at 4 p.m. CEST. The event will provide an in-depth update on Alligator's R&D pipeline, with a primary focus on its lead candidate mitazalimab, ahead of the upcoming TO 13 warrant exercise period (1-15 September 2025). During the event, members of Alligator's executive management and R&D leadership will: Provide update on mitazalimab clinical data, as well biomarker findings and Phase 3 readiness. Discuss ongoing and planned investigator-initiated trials (IITs) exploring mitazalimab in additional indications and clinical settings. Provide a brief update on the pipeline program HLX22. Outline key R&D milestones over the next 6-12 months. The R&D Day will be held as a live Teams webinar and will include a Q&A session. All participants will have the opportunity to submit questions in advance, via ir@ or during the event. Event detailsDate: Tuesday, 19 August 2025Time: 4-5 p.m. CESTFormat: Virtual Teams webinarRegistration: Please use this link to register A replay of the event will be made available on Alligator's website after the webinar. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 1:00 p.m. CEST on 14 August 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit Attachments Alligator Bioscience to host virtual R&D Day on 19 August 2025 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
20-05-2025
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Alligator Bioscience Announces Paediatric Study Waiver for Mitazalimab Granted by the European Medicines Agency
LUND, SE / / May 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical stage biotechnology company pioneering immuno-oncology therapeutics, today announced that the European Medicines Agency (EMA) has granted a waiver from conducting paediatric clinical trials for Alligator's lead asset mitazalimab. The waiver, issued as part of the Paediatric Investigation Plan (PIP) regulatory process, exempts Alligator from the obligation to conduct pediatric studies with mitazalimab in the treatment of pancreatic cancer. This regulatory milestone removes a key requirement ahead of potential future marketing authorization submissions in the European Union. Mitazalimab, a CD40 agonist antibody, is currently being evaluated in the OPTIMIZE-1 Phase 2 clinical trial in combination with chemotherapy for patients with previously untreated metastatic pancreatic cancer. Recent 24-month follow-up data demonstrate a survival rate of 29.4% for patients treated with mitazalimab in combination with mFOLFIRINOX, which is more than triple the estimated 8% survival rate for FOLFIRINOX alone. The median overall survival was reported at 14.9 months, and the median duration of response was 12.6 months, both indicating a favorable safety profile and encouraging survival outcomes. "This decision by the EMA allows us to continue advancing mitazalimab through late-stage development with a clear regulatory path to approval," said Søren Bregenholt, CEO of Alligator Bioscience. "While we remain committed to the highest standards of patient safety, this waiver recognizes that pancreatic cancer is extremely rare in pediatric populations and supports our focused efforts to address the significant unmet medical need in adults." Alligator will continue to engage with regulatory authorities in Europe and the United States as it prepares for potential registrational steps for mitazalimab. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 2:30 p.m. CEST on 20 May 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit Attachments Alligator Bioscience announces paediatric study waiver for mitazalimab granted by the European Medicines Agency SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
24-04-2025
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Alligator Bioscience AB Reports Financial Results for Q1 2025 and Provides a Business Update
LUND, SE / / April 24, 2025 / Alligator Bioscience (STO:ATORX) 24-month data from OPTIMIZE-1 show 29.4% survival rate for mitazalimab-three times higher than chemotherapy alone FDA alignment secured on Phase 3 strategy following successful End-of-Phase 2 meeting Rights issue completed with gross proceeds of SEK 153 million to support next development stage for mitazalimab Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX) "With the continued strengthening of mitazalimab's clinical profile-including 24-month survival data, further dose validation, and positive regulatory alignment-we are well-positioned for Phase 3 initiation in the second half of 2025. Combined with enhanced financial flexibility following the rights issue and strategic portfolio optimization, we are advancing with confidence toward our goal of delivering transformative immunotherapies for patients with hard-to-treat cancers."Søren Bregenholt, CEO of Alligator Bioscience BUSINESS UPDATEMitazalimab Announcement of encouraging overall survival benefit from the Phase 2 trial OPTIMIZE-1, with 24-month follow-up data showing a 29.4% survival rate for mitazalimab in combination with mFOLFIRINOX-three times higher than estimates for chemotherapy alone. Top-line data from the 450 µg/kg back-filled cohort in OPTIMIZE-1 further support 900 µg/kg as the recommended Phase 3 dose. Additional positive survival data for mitazalimab demonstrated through a literature-based indirect comparison, showing an incremental overall survival benefit and further supporting progression to Phase 3. Successful completion of End-of-Phase 2 meeting with the FDA with positive feedback and alignment on clinical development strategy and Phase 3 trial design. Company Approval of rights issue and reverse share split at Extraordinary General Meetings held on 13 January and 27 March 2025, respectively. Successful completion of rights issue in February 2025 with gross proceeds of SEK 153 million; BTUs converted and units issued to guarantors and Fenja Capital. Peer-reviewed publication of data for ATOR-1017 (evunzekibart) in the Journal for ImmunoTherapy of Cancer confirming its immunomodulatory effects. FDA grants Chinese Shanghai Henlius Orphan Drug Designation in gastric cancer for Alligator's out-licensed candidate HLX22. Publication of Alligator's Annual Report for 2024 on 27 March 2025, outlining operational and financial highlights. FINANCIAL SUMMARY FOR Q1 2025The financial summaries for the quarterly periods ending 31 March 2025 and 31 March 2024 are presented below. All amounts in MSEK,unless specified January - March2025 January - March2024 Net sales - 7.0 Operating profit/loss -43.7 -59.6 Profit/loss for the period -8.3 -62.8 Cash flow for the period -34.6 -26.2 Cash and cash equivalents 28.9 40.0 Earnings per share before and after dilution, SEK -1.1 -95.4 The full report is attached as a PDF, and is also available on the company's website: Alligator will host a webinar on Thursday, April 24 2025, at 2 p.m. CEST/ 8 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the January - March 2025 interim report, which will be followed by a Q&A session. The call will be held in English. Attendees need to register by following this link . For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 Johan Giléus, CFOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CEST on 24 April 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit . Attachments 2025 Q1 EN VF SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
Yahoo
27-03-2025
- Business
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Alligator Bioscience Publishes Annual Report for 2024
LUND, SWEDEN / / March 27, 2025 / Alligator Bioscience (STO:ATORX) today announced that the Annual Report for 2024, as well as the company's Remuneration Report, has been published. Because of environmental and cost reasons, Alligator Bioscience has chosen not to print the annual report. The Annual Report and the Remuneration Report are attached as PDFs and are available on the company's website. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 Johan Giléus, CFOE-mail: +46 (0) 46 540 82 00 This information is information that Alligator Bioscience is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-03-27 19:00 CET. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit Attachments Alligator Annual Report 2024 EN VFAlligator Remuneration Report 2024 EN VF SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire
Yahoo
21-03-2025
- Business
- Yahoo
Alligator Bioscience Announces Leadership Transition in Clinical Development
LUND, SWEDEN / / March 21, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that Dr. Sumeet Ambarkhane MD, Chief Medical Officer, will be leaving Alligator by end of March 2025. Dr. Ambarkhane has played a key role in advancing Alligator's immune-oncology pipeline and establishing its clinical development organization over the past years. In particular, he led the clinical development of mitazalimab and OPTIMIZE-1, Alligator's Phase 2 trial in metastatic pancreatic cancer towards its readiness for a Phase 3 confirmatory development. The company extends its sincere gratitude for his contributions and wishes him success in his future endeavors. Having worked with the company for an extended period, enabling a smooth transition, Dr. Tom Moore will assume the role as Chief Medical Officer. Dr. Moore is a seasoned oncology drug developer bringing industry experience from over a decade with Roche and subsequent work as a consultant, with deep experience in immuno-oncology and a strong commitment to advancing innovative treatments. His decision to step into the new role underscores his confidence in mitazalimab's potential and Alligator's mission to bring new therapeutic options to patients with high unmet medical needs. "Sumeet's dedication has been instrumental in driving mitazalimab forward, and we sincerely thank him for his contributions," said Søren Bregenholt, CEO of Alligator Bioscience. "We are now delighted to welcome Dr. Tom Moore as our new Chief Medical Officer. His deep expertise in immuno-oncology and clinical development will be a great asset as we work toward advancing mitazalimab into Phase 3 development." Dr. Moore will assume his role from the start of April ensuring a smooth transition in Alligator's clinical development leadership. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 5:45 p.m. CET on 21 March 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit Attachments Alligator Bioscience announces leadership transition in clinical development SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio
