- Mitazalimab OPTIMIZE-1 Phase 2 trial in pancreatic cancer completes enrolment following positive interim results; top-line data due Q1 2024
- FDA authorizes initiation of mitazalimab OPTIMIZE-2 Phase 2 trial in urothelial carcinoma
- Initiation of a Preferential Rights Issue for existing shareholder to close on May 12th 2023
Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX)
Successful first quarter with significant milestones achieved
"We began the year with the announcement of outstanding interim results from OPTIMIZE-1 which was followed just after the end of the first quarter with the completion of the study's patient enrolment and the confirmation that we remain on target to report top-line data at the beginning of Q1 2024. We are very pleased with our achievements so far with OPTIMIZE-1, where both the trial's progress and its results are surpassing our expectations and strengthening our already firm belief in mitazalimab's clinical and commercial potential. We are now looking forward to key efficacy data due in the next few months which, along with January's interim results, will form the basis of our discussions with regulators on mitazalimab's expected accelerated development in pancreatic cancer and route to market. The headway we are making with OPTIMIZE-1 has helped refine the design of mitazalimab’s next clinical trial, OPTIMIZE-2, in urothelial carcinoma. Our IND application has just been cleared by the FDA, paving the way for the study's initiation. The dosing of the first patient in our Phase 1 trial with Aptevo Therapeutics evaluating ALG.APV-527 in solid tumors expressing 5T4 completes our clinical achievements for this quarter and we are looking at the busy months ahead with excitement and anticipation."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab
- On January 2, Alligator announced positive interim results from the OPTIMIZE-1 Phase 2 trial in pancreatic cancer. Efficacy analysis showed mitazalimab combined with mFOLFIRINOX resulted in a 52% objective response rate (ORR), compared to an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population.
- The data confirm the safety of mitazalimab combined with mFOLFIRINOX as previously reported.
- Alligator plans to discuss these strong results with regulators once the interim progression free survival (PFS) data are reported in mid-2023 to explore the potential to accelerate mitazalimab's development and approval pathway in the US and Europe.
- On March 14, Alligator released a Key Opinion Leader (KOL) interview online featuring the OPTIMIZE-1 Principal Investigator Jean-Luc Van Laethem from Erasmus Hospital and Alligator Chief Medical Officer Sumeet Ambarkhane discussing the OPTIMIZE-1 interim results and putting them into context with current treatment options.
ALG.APV-527
- On February 13, Alligator and Aptevo Therapeutics announced the dosing of the first patient in the companies' Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4.
Expansion of the Research Collaboration and License Agreement with Orion Corporation
- On January 2, Alligator and Orion announced the initiation of the second program of their immuno-oncology collaboration to develop a bispecific antibody with potential applications in solid tumors.
New Chief Technology Officer announced
- On February 13, Alligator announced the promotion of Laura von Schantz to Chief Technology Officer to oversee all technical aspects in the development of Alligator's best-in-class preclinical and clinical pipeline.
Significant events after the end of the period:
Mitazalimab
- On April 3, Alligator announced that the US Food and Drug Administration (FDA) had cleared the company's Investigational New Drug (IND) application, allowing Alligator to initiate the OPTIMIZE-2 Phase 2 trial to evaluate the safety and efficacy of mitazalimab in combination with a PD-1 inhibitor in urothelial carcinoma. Alligator expects the OPTIMIZE-2 study to begin in H1 2024, or earlier subject to operational feasibility.
- On April 12, Alligator announced the completion of patient enrolment in the OPTIMIZE-1 Phase 2 study and confirmed that top-line data are expected in the beginning of Q1 2024.
Alligator presents at AACR Annual Meeting 2023
- On April 17, Alligator Principal Scientist Anette Sundstedt presented a poster entitled "ATOR-4066, a Neo-X-PrimeTM bispecific antibody targeting CD40 and CEA, activates myeloid cells in primary human tumors in vitro and induces anti-tumor immunity in vivo".
Alligator holds extraordinary general meeting
- On March 22, Alligator announced its intention to carry out a 91% secured rights issue of units of approximately SEK199 million.
- On April 24, Alligator held an extraordinary general meeting. The EGM resolved to approve the 91% secured rights issue of units of approximately SEK199 million, in accordance with the Board of Directors proposal.
FINANCIAL SUMMARY FOR Q1 2023
The financial summaries for the quarterly periods ending March 31st, 2023 and March 31st, 2022 are presented below.
| All amounts in MSEK, unless specified |
January – March 2023 | January – March 2022 |
| Net Sales | 9.6 | 5.4 |
| Operating profit/loss | -62.2 | -43.0 |
| Profit/loss for the period | -62.5 | -43.1 |
| Earnings per share (SEK) before and after dilution |
-0.28 | -0.20 |
| Cash Flow | -52.2 | -43.8 |
| Cash & Cash Equivalents | 44.8 | 234.4 |
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 conference call today at 12:30 p.m. CET / 6:30 a.m. ET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q1 2023 interim report, which will be followed by a Q&A chat session. The call will be held in English.
The livestream call can be accessed through Alligator's channels on LinkedIn or Youtube.
[1] Conroy et al, N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923