Alligator’s CEO: “We are on track to secure a partnership”
Alligator Bioscience is undertaking a restructuring and planning a rights issue of approximately SEK 280 million. This move aims to concentrate efforts on its lead drug candidate, mitazalimab, with the goal of securing a partnership and advancing it to a phase III trial. BioStock spoke with CEO Søren Bregenholt to learn more.
Alligator Bioscience is a biotech company focused on developing innovative cancer therapies. Its primary drug candidate, the CD40-agonistic antibody mitazalimab, has shown significant progress this year, particularly with topline data from the phase II OPTIMIZE-1 study and promising 18-month survival data. The study evaluates the candidate’s efficacy and safety in combination with mFOLFIRINOX as a first-line treatment for metastatic pancreatic cancer.
Sharpened focus on mitazalimab
Topline data revealed a doubling of the survival rate at 18 months compared to standard treatment. Alligator expects to publish 24-month data from the study in the first quarter of 2025, which could further confirm the candidate’s efficacy and potential for progression to phase III.
Last week, Alligator announced a restructuring aimed at prioritising the development of mitazalimab. The workforce will be reduced by approximately 70 per cent, primarily within research and development units, leading to annual savings of at least SEK 65 million. Remaining resources will primarily support late-stage development of mitazalimab and limited research activities. This shift marks a transition from broad research to focusing on realising the value of the company’s most promising asset.
Focus on financing and share issue
Meanwhile, the company has announced plans for a rights issue of units amounting to approximately SEK 280 million. After loan repayment, the proceeds will be used to support mitazalimab’s development toward phase III, secure a partnership for the drug candidate, and cover general corporate purposes. The rights issue is already backed by subscription commitments and guarantees covering around 50 per cent of the total rights issue.
The warrants included, series TO 10 and TO 11, could further strengthen the company’s cash position in 2025.
CEO insights
BioStock reached out to CEO Søren Bregenholt for more details about Alligator’s plans for the future.
Between January 29 – February 12, you will carry out a rights issue of units of approximately SEK 280 million. How are you going to use the proceeds and how much runway does the rights issue give you?
The proceeds from the rights issue will primarily be used to advance the development of mitazalimab towards phase 3 clinical trials and to secure a partnership for its continued development. We will continue our cost-conscious operations, and the secured level in the rights issue, including prudent assumptions regarding the outcome in TO10/11, will provide us with the necessary financing to sustain our operations until the end of 2025.
Why is it a good time to take part of this rights issue?
– We continue to believe strongly in mitazalimab as a potentially practice-changing treatment for metastatic pancreatic cancer. Mitazalimab has shown unprecedented survival benefits in the phase 2 trial OPTIMIZE-1. During Q1 2025 we are looking forward to key regulatory interactions with FDA and data read-outs, notably the 24-month follow-up from the trial. We are confident that mitazalimab will continue to deliver exceptional results, and that these data will add to the momentum of our dialogues with global and regional pharma companies around mitazalimab.
– Besides the unique opportunity to be part of developing a groundbreaking therapy, participating in this rights issue offers a significant potential financial upside. The warrant structure is designed to capture the expected value inflection points during 2025, including a licensing deal for mitazalimab.
You are also implementing a cost reduction programme. Can you elaborate on this?
– Yes, we are implementing a cost reduction programme to allow us to focus all our resources on mitazalimab and maximize long-term value creation. This involves a planned reduction of our workforce by approximately 70%, mainly within the discovery and non-clinical operations, a restructuring expected to save at least SEK 65 million annually.
– It is indeed heartbreaking to let go of all these exceptional, talented and dedicated colleagues who have personified Alligator’s unique spirit and mission to develop drugs for patients with hard-to-treat cancers. I am confident they will continue to be valuable contributors to other innovative organization. Their commitment to Alligator only strengthens our determination to ensure that mitazalimab reaches the patients as soon as possible.
You recently indicated that a partnership for the continued development of mitazalimab is most likely to materialize in 2025. Is this timeline still on track, and what factors could influence whether this milestone is achieved or delayed?
– We are on track to secure a partnership for mitazalimab during the first half 2025, however as I said before, we alone do not control these timelines.
– As I just mentioned, we have a number of inflection points during Q1 2025, including the 24-month follow-up data on the 900 µg/kg cohort, and top-line data from the low dose cohort in the phase 2 trial. Add to that FDA meetings on manufacturing phase 3 readiness and sign-off on phase 3 design. Together we believe that this will add momentum to the ongoing discussions and move us towards a licensing agreement.
– With this reorganization, we maintain the capabilities and capacity to deliver on these mitazalimab objectives in our usual timely and high-quality manner, and provides us with the runway to find the optimal partner for our lead candidate.
How will you be prioritizing your efforts through 2025?
– Our primary focus and resource allocation through 2025 will be on advancing mitazalimab towards phase 3 clinical trials and securing a partnership for its continued development. In parallel we will continue to strategically evaluate our other assets to determine the best path forward for each, ensuring that we maximize value creation for our shareholders.
With a sharpened focus on advancing mitazalimab, does the company have plans to further monetize other assets in the pipeline, similar to the recent deal with Orion?
– While we are sharpening our focus on mitazalimab, we are of course continuously evaluating our pipeline to identify opportunities to monetize other assets in our pipeline.
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