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 / ACCESS Newswire / 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 UPDATE
Mitazalimab
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 2025
The financial summaries for the quarterly periods ending 30 June 2025 and 30 June 2024 are presented below.
All amounts in MSEK, | April - June | April - June |
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 2025
The financial summaries for the half-year periods ending 30 June 2025 and 30 June 2024 are presented below.
All amounts in MSEK, | January - June | January - June |
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: https://alligatorbioscience.se/en/investors/financial-reports/
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, 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
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 alligatorbioscience.com.
Attachments
2025 Q2 EN V1 0
SOURCE: Alligator Bioscience
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/alligator-bioscience-ab-reports-financial-results-for-q2-2025-and-provides-a-business-1047543
