LUND, SE / ACCESS Newswire / 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 UPDATE
Mitazalimab
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 2025
The financial summaries for the quarterly periods ending 31 March 2025 and 31 March 2024 are presented below.
All amounts in MSEK, | January - March | January - March |
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: https://alligatorbioscience.se/en/investors/financial-reports/
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, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
Johan Giléus, CFO
E-mail: johan.gileus@alligatorbioscience.com
Phone: +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 alligatorbioscience.com .
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