The recent phase II success with mitazalimab means that Alligator Bioscience can now start preparing for phase III. Besides mitazalimab, the Lund-based biotech also has other promising projects in its pipeline. Now, Alligator is carrying out a SEK 150.9 million rights issue to bring all of the projects even further. BioStock talked to CEO Søren Bregenholt to discuss the rights issue in more depth.

Alligator Bioscience specialises in developing tumour-directed immunotherapies – drugs that are designed in such a way that the immunostimulatory effect is localised to the tumour. The concept results in a favourable safety and efficacy profile for these therapies. For this purpose, the Lund-based biotech has a broad pipeline of projects aimed at specific molecular targets, mainly CD40 and 4-1BB. Both of these targets have been shown to boost immune activation in tumours.

Reaching proof-of-concept with mitazalimab

At the start of the year, Alligator had a major breakthrough with its lead candidate mitazalimab, a CD40 agonist. The company announced reaching proof-of-concept in a phase II trial evaluating mitazalimab in first-line metastatic pancreatic cancer patients when combined with mFOLFIRINOX (standard-of-care chemotherapy for this group of patients). The results from the trial (find the key figures here) led to the endorsement of a phase III study by the FDA.

Now, Alligator is scouting for potential partners to carry out the trial, which is expected to be initiated in early 2025.

ATOR-4066 and Neo-X-Prime

Mitazalimab is not the only CD40 agonist being developed by Alligator. ATOR-4066 (“4066”) is still in preclinical development, but based on encouraging results published at major scientific conferences like AACR and SITC, Alligator believes that this candidate can provide significant clinical benefit either alone or in combination with standard-of-care for patients suffering from gastric, colorectal or other cancers.

4066 was discovered using Alligator’s propriatary Neo-X-Prime platform, which, according to the company, offers the opportunity to develop additional tumour-targeting, and non-competing CD40 agonists across different cancers. Alligator is currently designing and engineering additional proprietary molecules using the platform.

The 4-1BB target

The other molecular target explored by Alligator is 4-1BB. The company recently announced interim phase I data from ALG-APV.527 (“527”), a joint venture with Aptevo Therapeutics. The results show that the treatment was well-tolerated. Furthermore, signs of clinical activity and favourable pharmacodynamic activity were seen in two heavily pre-treated patients with breast cancer, supporting the biological activity of the drug.

For more details about the 527 data, read here.

Rights issue drives further development

With such an intense development pipeline, Alligator has decided to carry out a rights issue of approximately SEK 150.9 million.

The proceeds will mainly be utilised to continue the phase II development and preparations for phase III with mitazalimab in pancreatic cancer. Furthermore, Alligator will be able to advance 527 in the phase I study and continue development of other pipeline candidates including 4066, which Alligator hopes to advance towards phase I clinical trials as fast as possible.

CEO insights

BioStock got in touch with Alligator’s CEO Søren Bregenholt to learn more about the company’s projects and the ongoing rights issue.

Having proof-of-concept with Mitazalimab means that now focus is now on finding a partner. How is that process going?

– We have been discussing the very encouraging data we achieved in the OPTIMIZE-1 study extensively with potential partners and we have received a lot of  engagement in return. It is our intention to find the commercial partner best suited to assist us in bringing mitazalimab through phase III development, regulatory approval and then onto market as quickly and efficiently as possible. However, we also remain focused on providing outstanding returns to our stakeholders and we are therefore considering several options for how best to achieve our goals for mitazalimab. Given the great clinical progress our lead asset has shown to date and the highly positive feedback we have received from key opinion leaders in Europe and the US, I am more certain than ever that we will secure mitazalimab’s route to market in a way that will bring the most benefit to our stakeholders.

With several projects ongoing, how are you prioritising your efforts through 2024?

– We remain completely focused on our dual goals of maximising our chances of developing innovative immuno-oncology therapies while ensuring the best returns for our stakeholders. To achieve this, we operate in a very lean, efficient, and agile manner, tailoring our operations to best suit the upcoming requirements of our business. We recently announced a planned restructuring to align our resources with our strategic objectives and reduce our cost base. Now that we have validated the differentiated CD40 approach, we are pushing our Neo-X-Prime bispecific antibody ATOR-4066 to strengthen its preclinical data package and prepare it for clinical development in different tumour types compared to mitazalimab. We also maintain a very careful balance between the advancement of our internal projects and our joint projects, ensuring we always deliver on our promises and commitments to our highly valued partners.

– Moreover, we recently saw the first and very encouraging clinical data for ALG.APV-527, warranting continued development. As this programme is co-developed with Aptevo, it provides a risk balanced opportunity to diversify the pipeline beyond CD40.

Can we expect new targets coming from the Neo-X-Prime platform to be announced soon?

– The Neo-X-Prime concept is a very powerful technology platform that can produce top-quality antibodies against specific targets in an extremely fast and cost-effective way. The preclinical data we have already achieved with ATOR-4066 demonstrates the enormous potential of these antibodies. We are working a number of early promising new Neo-X-Prime projects, including our collaboration with Macrogenics, and look forward to disclosing the targets and data the as they mature. In addition we are discussing potential platform collaboration with potential pharma partners.

You are currently carrying out a rights issue of initially SEK 150.9 million. How are you going to use the proceeds and how much runway does the rights issue give you?

– Our track record at Alligator speaks for itself. Over the last three years, we demonstrated with our OPTIMIZE-1 trial that we can generate industry-leading clinical data for a target which no other companies were able to create a therapeutic solution against. And we achieved that in a cost-effective manner and in a much shorter timeframe than originally anticipated. Now, with investor interest in biotech coming back, I believe the time is right for us to push ahead with our journey to develop innovative immuno-oncology treatments and to generate more outstanding clinical data. We are therefore raising this financing not only to complete the preparations for mitazalimab’s phase III clinical evaluation, but also to accelerate ATOR-4066s development towards phase I clinical trials. As ATOR-4066 have already demonstrated the capacity to induce superior anti-tumour immunity compared to CD40 monospecific antibodies along with the ability to remodel the tumour microenvironment, this could be transformational for Alligator.

Finally, with this ongoing rights issue, what should motivate investors to participate?

– As we have highlighted, Alligator has a proven track record of generating outstanding data which is highly differentiated for hard-to-treat cancers, and for consistently delivering milestones on time and on budget. These qualities stand out in the biotech space, and they set Alligator apart from most other companies in the field. The mitazalimab OPTIMIZE-1 phase II data is the first step in what I believe will be a long and successful journey for the company, and I believe that when investors look at Alligator they will find our goals and achievements compelling and they will be convinced by the amazing potential ahead of us.

IMPORTANT INFORMATION

This material constitutes an introduction to the rights issue of units in Alligator (the ”Rights Issue”) and should be regarded as marketing material. The material is not and shall not be considered to constitute a prospectus in accordance with applicable laws and regulations. Invitation to shareholders and the public to subscribe for units in the Rights Issue takes place only through the prospectus that has been approved and registered by the Swedish Financial Supervisory Authority (the ”Prospectus”), and which has been published on www.alligatorbioscience.se/en/investors/preferential-rights-issue-q1-2024/. The Swedish Financial Supervisory Authority’s approval of the Prospectus shall not be construed as an approval of the new shares or warrants. In order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, any investment decision should only be made based on the information in the Prospectus. Investors are advised to read the full Prospectus.

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