- European Medicines Agency grants mitazalimab Orphan Designation in pancreatic cancer
- Technical Feasibility achieved in second collaboration program with Orion triggering milestone payment to Alligator
- Successful warrant exercise raises SEK 13.8 million
- CD40 programs and in particular mitazalimab data presented at renowned international medical conferences and published in a scientific article
- New mitazalimab patent granted in Europe
Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX)
"During another busy and productive quarter for Alligator we achieved one more important milestone in the clinical and commercial development of our lead asset with the addition of orphan designation for mitazalimab in pancreatic cancer by the European regulator. This follows our receipt of orphan drug designation in the US from the FDA and means we have now secured greater commercial protection for mitazalimab upon approval in our two key markets, the US and the EU. Over the summer, we showcased mitazalimab's scientific achievements at several prestigious industry conferences, through which we continue to raise mitazalimab's profile among the world's top oncologists, investors and potential partners. On the partnership front, we reported the achievement of Technical Feasibility in one of our collaboration programs with Orion, which triggered a milestone payment to us. Our work with Orion is a great example of the benefits these strategic collaborations can deliver for our company and our shareholders. We have much to look forward to in the coming months, in particular the next major inflection point in our OPTIMIZE-1 study, which is due to report its top-line Phase 2 data at the start of next year and which will mark the start of the next stage of mitazalimab's route to market."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab
- On September 28-29, Alligator presented twice at the 2023 AACR (American Association for Cancer Research) Special Conference on Pancreatic Cancer held in Boston. The first presentation was an oral presentation entitled "CD40 agonist mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Interim efficacy results of the OPTIMIZE phase 1b/2 study". The second was a poster presentation entitled "Interim pharmacodynamic analyses of mitazalimab in combination with FOLFIRINOX in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) identify CD4 effector T cells as a correlate of treatment outcomes".
- On September 21, Alligator presented a poster at the 2023 International Cancer Immunotherapy Conference (CICON) held in Milan, entitled "Efficacy and pharmacodynamic biomarkers of mitazalimab in combination with chemotherapy in preclinical mouse models".
- On August 21, Alligator announced that the European Medicines Agency had granted Orphan Designation to mitazalimab for the treatment of pancreatic cancer. The designation confers significant financial and regulatory benefits, including 10 years of marketing approval in the EU after product approval.
- On July 19, Alligator presented an oral presentation at the 3rd Annual Tumor Myeloid-Directed Therapies Summit held in Boston entitled "Targeting CD40 on Myeloid Cells to Reverse the Suppressive Tumor Microenvironment & Enhance T Cell Priming".
Exercise of Warrants
- On September 1, Alligator announced it would receive approximately SEK 13.8 million through the exercise of warrants of series TO 6, which represents an utilization rate of approximately 68 percent of the warrants attached to shares acquired through the preferential rights issue that took place in April 2023.
Milestone achieved in collaboration with Orion
- On July 31, Alligator announced that Technical Feasibility had been achieved in the second program of the Company's research collaboration and license agreement with Orion, triggering a new milestone payment to Alligator.
Significant events after the end of the period:
Mitazalimab
- On October 11, the European Patent Office granted Alligator a new patent covering mitazalimab's composition of matter until 2038, including a potential supplementary term. The patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia and more.
ATOR-1017
- On October 5, Alligator announced the publication of a peer-reviewed article entitled "ATOR-1017, an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1" in the journal Cancer Immunology, Immunotherapy.
FINANCIAL SUMMARY FOR Q3 2023 and YEAR-TO-DATE 2023
The financial summaries for the quarterly periods ending September 30th, 2023 and September 30th, 2022 are presented below.
| All amounts in MSEK, unless specified | July - September 2023 | July - September 2022 |
| Net Sales | 19.4 | 5.1 |
| Operating profit/loss | -52.7 | -51.2 |
| Profit/loss for the period | -52.5 | -51.4 |
| Earnings per share (SEK) before and after dilution | -0.08 | -0.23 |
| Cash Flow | -86.5 | -45.6 |
| Cash & Cash Equivalents including short-term financial assets | 123.9 | 147.4 |
The financial summaries for the year-to-date periods ending September 30th, 2023 and September 30th, 2022 are presented below.
| All amounts in MSEK, unless specified | January - September 2023 | January - September 2022 |
| Net Sales | 46.4 | 15.6 |
| Operating profit/loss | -178.6 | -140.1 |
| Profit/loss for the period | -178.8 | -140.2 |
| Earnings per share (SEK) before and after dilution | -0.45 | -0.64 |
| Cash Flow | -23.1 | -131.0 |
| Cash & Cash Equivalents | 123.9 | 147.4 |
The full report is attached as a PDF, and is also available on the company's website via this link.
Alligator will host a conference call today at 12:30 p.m. CEST/ 6:30 a.m. ET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q3 interim report, which will be followed by a Q&A session. The call will be held in English.
The livestream call can be accessed through Alligator's channels on LinkedIn or Youtube.
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
LifeSci Advisors
Investor Relations
Guillaume van Renterghem
E-mail: gvanrenterghem@lifesciadvisors.com
Phone: +41 (0) 76 735 01 31
The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CEST on October 26, 2023.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime, and novel drug candidates based on the RUBY bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc.
Alligator Bioscience's shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden.
For more information, please visit alligatorbioscience.com.
