- Substantial overall survival benefit and unprecedented Duration of Response reported in 18-month analysis from mitazalimab OPTIMIZE-1 Phase 2 study in 1st line pancreatic cancer
- Positive Phase 2 mitazalimab data published in The Lancet Oncology
- Johan Giléus appointed as new Chief Financial Officer
- Orion exercises development option in research collaboration and license agreement triggering milestone payment to Alligator
- Cash runway extended to Q1 2025 through financing of up to SEK 80 million
Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX)
“This quarter we have continued to push forward with the clinical and commercial development of our robust immuno-oncology pipeline. Our lead asset mitazalimab demonstrated improved median Overall Survival at the 18-month follow-up mark, building on the impressive OPTIMIZE-1 Phase 2 top-line readout in pancreatic cancer we announced at the start of the year. Our preparations for mitazalimab’s Phase 3 are progressing well, along with our efforts to secure a commercial partnership. We were very pleased to see the Moores Cancer Center initiate its Phase 1 clinical study of mitazalimab injected intratumorally in patients with locally advanced pancreatic cancer. In fact, we have received a significant increase in interest from the scientific community on the potential evaluation of mitazalimab in a number of investigator-initiated trials in different tumor types. This is a highly encouraging sign of mitazalimab’s growing reputation as a combination therapy in pancreatic cancer whose applicability can be broadened to other indications.”
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab
- On June 26, Alligator announced positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study in pancreatic cancer, demonstrating a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX[1] alone. The data also demonstrated an increase in the updated median Overall Survival to 14.9 months, increases in both the confirmed (42.1%) and unconfirmed (54.4%) Objective Response Rate, and an unprecedented median Duration of Response of 12.6 months. These latest OPTIMIZE-1 results compare favorably to the previously reported outcomes with first line chemotherapies FOLFIRINOX[1]and NALIRIFOX[2].
- On June 3, Alligator announced the publication of a scientific article entitled “Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study” in the world-leading clinical oncology research journal, The Lancet Oncology.
- On May 14, Alligator announced the initiation of an investigator-initiated Phase 1 clinical study evaluating the safety and efficacy of mitazalimab injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The study is being conducted by researchers at the Moores Cancer Center at UC San Diego (NCT06205849) and is being financed by the US National Cancer Institute.
- On April 8, “Mitazalimab, a potent CD40 agonist in combination with FOLFIRINOX demonstrates changes consistent with increased immune activation in TME[3] and peripheral blood in a preclinical pancreatic cancer tumor model” was presented by Alligator at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California.
- On June 1, “CD4 effector T cell expansion to identify objective responses to the CD40 agonist mitazalimab in combination with modified FOLFIRINOX (mFFX) as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC) in the OPTIMIZE-1 study“ and “OPTIMIZE-1 primary analysis: Safety, efficacy and biomarker results of a phase 1b/2 study combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)” was presented by Alligator at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
- On June 29, “CD40 agonist mitazalimab combined with mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Primary analysis of the OPTIMIZE-1 phase 1b/2 study” was presented by Alligator at the European Society for Medical Oncoloy Gastrointestinal conference in Münich, Germany.
ATOR-4066
- On April 9, “ATOR-4066, a Neo-X-Prime™ bispecific antibody targeting CD40 and CEACAM5, induces tumor localized immune cell activation in preclinical in vivo tumor model” was presented by Alligator at the AACR Annual Meeting in San Diego, California.
CD40 Publication
- On May 20, Alligator announced the publication of a scientific article entitled “Next generation CD40 agonists for cancer immunotherapy” in the peer-reviewed medical journal Expert Opinion on Biological Therapy.
Exercise of development option by Orion
- On April 26, Alligator announced that Orion Corporation, a global pharmaceutical company based in Finland, had selected the lead bispecific antibodies from the companies’ second development program, and was exercising its option to develop these molecules under the existing 2021 research collaboration and research agreement. The exercise of this development option triggered an undisclosed milestone payment to Alligator.
HLX22 (AC101)
- On May 21, Alligator announced that Shanghai Henlius Biotech, Inc. had received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin®) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients.
New Chief Financial Officer announced
- On June 14, Alligator announced the appointment of Johan Giléus as the company’s new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.
Financing
- On April 9, Alligator announced it will receive SEK 107.1 million in gross proceeds from the Preferential Rights Issue approved at the Extraordinary General Meeting held on March 14.
- On June 25, Alligator announced a financing agreement with Fenja Capital worth up to SEK 80 million, providing financial and strategic flexibility and extending the company’s cash runway into the first quarter of 2025.
Significant events after the end of the period:
Mitazalimab
- On July 10, Alligator announced the completion of the recruitment of the 450 μg/kg back-fill cohort to the OPTIMIZE-1 study. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness.
FINANCIAL SUMMARY FOR Q2 2024 and H1 2024
The financial summaries for the quarterly periods ending June 30th, 2024 and June 30th, 2023 are presented below.
| All amounts in MSEK, unless specified |
April – June 2024 | April – June 2023 |
| Net Sales | 7.6 | 17.4 |
| Operating profit/loss | -47.4 | -63.7 |
| Profit/loss for the period | -49.2 | -63.7 |
| Cash & Cash Equivalents | 77.5 | 160.6 |
| Cash Flow for the period | 37.4 | 115.6 |
| Earnings per share (SEK) before and after dilution |
-0.07 | -0.19 |
The financial summaries for the half-yearly periods ending June 30th, 2024 and June 30th, 2023 are presented below.
| All amounts in MSEK, unless specified |
January – June 2024 | January – June 2023 |
| Net Sales | 14.6 | 27.0 |
| Operating profit/loss | -107.0 | -125.9 |
| Profit/loss for the period | -112.0 | -126.3 |
| Cash & Cash Equivalents | 77.5 | 160.6 |
| Cash Flow for the period | 11.3 | 63.4 |
| Earnings per share (SEK) before and after dilution |
-0.16 | -0.46 |
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 on Thursday, July 11, at 4:15 p.m. CEST/ 10:15 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Dr. Sumeet Ambarkhane will present and comment on the Q2 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 YouTube.
[1] Conroy et al., N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923
[2] Wainberg et al., Lancet 2023; 402(10409):1272-1281; DOI: 10.1016/S0140-6736(23)01366-1
[3] Tumor Micro Environment