Alligators vd: “We are on track to secure a partnership”
Alligator Bioscience genomför en omstrukturering samt planerar för en företrädesemission om cirka 280 Mkr. Detta för att skärpa fokus på sin ledande läkemedelskandidat mitazalimab, med målet att säkra ett partnerskap och ta kandidaten genom en fas III-studie. BioStock har pratat med vd Søren Bregenholt för att få veta mer.
Alligator Bioscience är ett bioteknikbolag med fokus på utveckling av innovativa cancerterapier. Bolagets främsta läkemedelskandidat, den CD40-agonistiska antikroppen mitazalimab, har i år gjort positiva utvecklingsframsteg, i synnerhet topline-data från fas II-studien OPTIMIZE-1, samt övertygande överlevnadsdata från 18-månadersuppföljningen. Studien utvärderar läkemedelskandidatens effekt och säkerhet i kombination med mFOLFIRINOX som första linjens behandling vid metastaserad bukspottkörtelcancer.
Skärpt fokus på mitazalimab
Topline-data visade en fördubblad överlevnadsgrad vid 18 månader jämfört med standardbehandling. Under första kvartalet 2025 väntas Alligator publicera 24-månadersdata från studien, vilket ytterligare kan bekräfta kandidatens effekt och potential att tas vidare till fas III.
Alligator gick förra veckan ut med att man genomför en omstrukturering för att prioritera utvecklingen av mitazalimab. Arbetsstyrkan minskas med cirka 70 procent, främst inom forsknings- och utvecklingsenheterna, vilket väntas ge besparingar på minst 65 Mkr årligen. Kvarvarande resurser kommer främst användas till sen utveckling av mitazalimab och mindre forskningsaktiviteter. Detta innebär ett skifte från bred forskning till fokus på att realisera värdet av bolagets mest lovande tillgång.
Emission och finansiering i fokus
Bolaget gick samtidigt ut med att man planerar för en företrädesemission av units om cirka 280 Mkr. Kapitalet kommer gå till att återbetala lån och stödja utvecklingen av mitazalimab mot fas III och säkra ett partnerskap för läkemedelskandidaten, samt för allmänna företagsändamål. Emissionen stöds redan av teckningsförbindelser och garantiåtaganden som omfattar cirka 50 procent av den totala emissionen.
Optionerna i emissionen, av serierna TO 10 och TO 11, kan ytterligare stärka bolagets kassa under 2025.
Vd berättar mer
BioStock kontaktade vd Søren Bregenholt för att få veta mer om planerna för Alligator framöver.
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.
