December 2, 2024
About Alligator Bioscience AB (publ)
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. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.
Background and motive
The clinical drug candidate mitazalimab (previously ADC-1013) is an agonistic, or stimulatory, antibody that targets CD40, a receptor on the dendritic cells of the immune system, which are the cells that detect enemies such as cancer cells. In preclinical experimental models, mitazalimab has been shown to induce a potent tumor-targeted immune response and provide long-lasting tumor immunity. In addition, preclinical data have demonstrated how mitazalimab can be used against multiple types of cancer. The study OPTIMIZE-1 is an open-label, multi-center trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFOLFIRINOX) in patients with first line metastatic pancreatic cancer. The trial was initiated in Q3 2021, and top line data was announced on 29 January 2024 showing that the trial met the primary endpoint. On 26 June 2024, the Company announced 18-month data, demonstrating an Objective Response Rate of 42.4 percent, a Median Overall Survival of 14.9 months and a survival rate at 18 months of 36.2 percent, nearly twice as high as the 18.6 percent previously reported for FOLFIRINOX. Together these data confirm the benefit of mitazalimab in combination with mFOLFIRINOX. On 24 October 2024, the Company announced that 16 patients were still in the study and that at least 6 patients had been in the study for more than two years, thus further strengthening the case for mitazalimab. The Company expects to announce 24-month follow-up data during Q1 2025 together with the conclusion from a number of planned interactions with the US FDA.
Alligator Bioscience has today separately announced a sharpened focus on mitazalimab and the implementation of a cost reduction program to maximize long-term value creation, which is assessed to potentially enable a reduction of approximately 70 percent of the current workforce, mainly affecting the discovery and non-clinical operations. Once implemented, the restructuring is expected to reduce operational costs by at least SEK 65 million annually. Going forward, Alligator Bioscience will focus on late-stage development with an adequate workforce of approximately 15 FTEs. Furthermore, Alligator Bioscience will continue to be able to conduct limited research activities, primarily related to mitazalimab, through internal and external resources.
Given the capital needs that the Company's development and commercialization plans give rise to, Alligator Bioscience assesses that its existing working capital, together with the potential capital raise from the warrants series TO 9, exercisable in December 2024, is not sufficient to cover the Company's capital needs for the upcoming twelve months. To ensure continued successful progress in accordance with the Company's revised business plan and strategy, Alligator Bioscience has therefore decided to carry out the Rights Issue.
Website: https://alligatorbioscience.se/en/