Latest news with #AlligatorBioscience
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Alligator Bioscience Provides Highlights from R&D Event 2025
LUND, SE / / August 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, provides key highlights from its R&D event held on 19 August 2025. The event featured presentations from Alligator's management and scientific leadership, outlining Alligator's clinical progress, upcoming milestones, and strategic outlook. Key takeaways from the event include: Mitazalimab - Phase 3 readiness : Long-term follow-up data continue to demonstrate encouraging overall survival in metastatic pancreatic cancer, supporting the confirmed regulatory path and planned initiation of a Phase 3 trial. Scientific insights : New translational biomarker data further expand and strengthen the rationale for mitazalimab in pancreatic cancer and other solid tumors, underscored by myeloid and T-cell activation and their correlation with improved clinical outcomes. Trial completion and CMC status: The final, 30-month, data read-out from OPTIMIZE-1 is expected during Q3 2025. The trial will thereafter be finalized, with mitazalimab being provided to patients still on treatment, and sites with ongoing patients remain open under limited, risk-based monitoring; manufacturing of Phase 3 material has been successfully completed. Investigator-initiated trials (IITs) : Based on the significant investigator interest Alligator is engaged in a number of externally funded exploratory and Phase 2 clinical trials with mitazalimab across pancreatic, gastrointestinal and other solid tumors to expand mitazalimab's future clinical use. Individual trials are expected to start during H2 2025 and the first half of 2026. Pipeline updates : The HER2 antibody HLX22 (developed by Chinese Henlius) has entered a global Phase 3 trial in gastric cancers. Alligator expects to receive the next development milestone within 6-12 months, and estimates that its share of the future royalties will amount to SEK 150-400 million annually. Strategic outlook : With a reduced burn-rate, Alligator is well positioned to advance mitazalimab into registrational trials together with a partner, and in parallel explore additional development options for the asset. Together mitazalimab and HLX22 represent a significant financial upside for Alligator. Other pipeline assets and technologies represent additional future development and income opportunities. A replay of the event is available through >>this link<< . 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 12:15 p.m. CEST on 20 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 ready 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 provides highlights from R&D event 2025 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire
Yahoo
14-08-2025
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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
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14-07-2025
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Alligator Bioscience Comments on Henlius Dosing First Patient in the US in Phase 3 Trial of HLX22 in Gastric Cancer
LUND, SWEDEN / / July 14, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) today comments on the announcement by Shanghai Henlius Biotech, Inc. that it has dosed the first patient in the United States in its global Phase 3 clinical trial (NCT06532006) of HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer. HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues. "We are encouraged to see Henlius dose the first patient in the United States in the Phase 3 trial of HLX22, reflecting continued momentum for this promising program in HER2-positive gastric cancer," commented Søren Bregenholt, CEO of Alligator Bioscience. "While Alligator is not directly involved in the development, we follow it closely as it represents an opportunity for meaningful revenue streams from milestones and royalties upon the future approval of HLX22." Under the terms of the agreement, Alligator is entitled to 35% of AbClon's revenue from its sublicense agreement with Henlius. 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 3:00 p.m. CEST on 14 July 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 comments on Henlius dosing first patient in the US in Phase 3 trial of HLX22 in gastric cancer SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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10-07-2025
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Alligator Bioscience AB Reports Financial Results for Q2 2025 and Provides a Business Update
GMP manufacturing completed, paediatric waiver granted, positive outcome from FDA and EMA interactions; advancing mitazalimab toward Phase 3 readiness Biomarker data from OPTIMIZE-1 presented at ASCO, supporting patient stratification and clinical potential Warrant programme TO 12 completed, with gross proceeds of SEK 61 million and further strengthening financial position LUND, SE / / July 10, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) "With key regulatory and manufacturing milestones achieved for mitazalimab and strengthened financials, we remain focused on identifying a strategic partner and initiating Phase 3. During the quarter, we successfully completed GMP manufacturing and received clear regulatory feedback from both the FDA and EMA-confirming dose, trial design and paediatric waiver-further strengthening the program's foundation. In parallel, new biomarker data presented at ASCO reinforced mitazalimab's clinical potential and relevance for patient stratification. Combined with the proceeds from TO 12, these developments move us into the next exciting stage of mitazalimab's journey." Søren Bregenholt, CEO of Alligator Bioscience BUSINESS UPDATEMitazalimab Completion of GMP manufacturing for mitazalimab to support Phase 3 trial readiness in collaboration with development partner. Paediatric study waiver granted by the European Medicines Agency, streamlining regulatory path ahead of future MAA submission. Presentation of biomarker data from the Phase 2 trial OPTIMIZE-1 at ASCO 2025, showing mitazalimab-induced immune modulation and identifying biomarkers linked to improved outcomes in metastatic pancreatic cancer. Confirmation from FDA of 900 ug/kg dose and positive scientific advice from EMA further strengthen mitazalimab's regulatory foundation ahead of Phase 3. Company Annual General Meeting held on 7 May 2025; adoption of updated dividend policy aligned with sharpened strategic focus and potential proceeds from asset monetization. Execution of 1:1000 reverse share split in April 2025, followed by recalculation of terms for TO 12 and TO 13 warrants. Successful completion of warrant programme TO 12 in May 2025, with 71% of options exercised and SEK 61 million raised before issue costs and partial repayment of loan. Adjustment of total number of shares to 34,803,898 following TO 12 warrant exercise and share split. Initiation of Phase 2 clinical trial with HLX22 in HER2-positive breast cancer by Shanghai Henlius; EU Orphan Drug Designation granted for HLX22 in gastric cancer. FINANCIAL SUMMARY FOR Q2 2025The financial summaries for the quarterly periods ending 30 June 2025 and 30 June 2024 are presented below. All amounts in MSEK,unless specified April - June 2025 April - June 2024 Net sales - 7.6 Operating profit/loss -22.3 -47.4 Profit/loss for the period -1.7 -49.2 Cash flow for the period 5.1 37.4 Cash and cash equivalents 33.9 77.5 Earnings per share before and after dilution, SEK -0.08 -66.36 FINANCIAL SUMMARY FOR H1 2025The financial summaries for the half-year periods ending 30 June 2025 and 30 June 2024 are presented below. All amounts in MSEK,unless specified January - June 2025 January - June 2024 Net sales - 14.6 Operating profit/loss -66.0 -107.0 Profit/loss for the period -10.0 -112.0 Cash flow for the period -29.6 11.3 Cash and cash equivalents 33.9 77.5 Earnings per share before and after dilution, SEK -0.69 -158.50 The full report is attached as a PDF, and is also available on the company's website: Alligator will host a webinar on Thursday, July 10 2025, at 3 p.m. CEST/ 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the April - June 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 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 2025-07-10 08:00 CEST. 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 Q2 EN V1 0 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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13-06-2025
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Alligator Bioscience Receives FDA Endorsement of Mitazalimab Phase 3 Dose for Pancreatic Cancer
LUND, SE / / June 13, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback supporting the selection of the 900 µg/kg dose of its CD40 agonist mitazalimab for the planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC). This positive regulatory feedback confirms Alligator's dose selection and represents a key milestone in the late-stage development of mitazalimab. "We are very pleased with the FDA's timely and constructive response. This marks an important step forward as we finalize our Phase 3 program for mitazalimab in one of the most aggressive and underserved cancers. We are now in active partnering dialogues aiming to secure the right partner to take mitazalimab into Phase 3," said Søren Bregenholt, CEO of Alligator Bioscience . 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 8:45 a.m. CEST on 13 June 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 receives FDA endorsement of mitazalimab Phase 3 dose for pancreatic cancer SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
