- Interim results from mitazalimab OPTIMIZE-1 Phase 2 trial in pancreatic cancer exceed 50% Objective Response Rate, the trial passes pre-planned futility and continues towards full enrolment
- Alligator and Orion initiate the second program of their immuno-oncology research collaboration and license agreement
- Shanghai Henlius Biotech receives IND approval for second Phase 2 clinical trial of AC101 (HLX22) in gastric cancer in China
Lund, Sweden – Alligator Bioscience AB (Nasdaq Stockholm: ATORX)
Strong final quarter concludes a successful 2022
“We have made excellent progress in the clinic throughout the year which culminated with the outstanding Phase 2 interim results from our lead asset mitazalimab in the OPTIMIZE-1 trial. The encouraging 52% ORR from our study strongly indicates contribution of mitazalimab to the known activity of FOLFIRINOX chemotherapy backbone, with a manageable safety profile. An objective response indicates clinically meaningful reduction in the tumor burden, and a long duration of response can positively influence patient’s survival. With the continued enrolment for the remainder of the trial, the ongoing treatment and follow up we are now looking forward to announcing interim data on the longevity of response and survival in mid-2023 and we are confident that we will be able to initiate discussions with regulators in the US and Europe in H2 2023 on potentially accelerating the asset's development and its route to market.We continue to strengthen and expand our existing partnerships and collaborations. Our co-development of ALG.APV-527 with Aptevo continues advancing towards the initiation of a Phase 1 study in the US, and we have initiated a second bispecific project in our research collaboration with Orion. Finally, our out-licensed asset AC101 (HLX22) has received IND approval for a second Phase 2 study in gastric cancer in China. We are very well placed for 2023 and looking ahead to what we expect will be a busy and productive year.”
Søren Bregenholt, CEO Alligator Bioscience AB
BUSINESS UPDATE
Clinical Pipeline:
Mitazalimab
- Alligator presented a poster at the SITC Annual Meeting in November outlining Phase 1 dose escalation data showing mitazalimab induces strong immune responses in patients with advanced stage solid tumors, further strengthening the CD40 agonist's proof of mechanism and potential in solid tumors.
- In December, additional data from this Phase 1 study was published in the peer-reviewed journal Investigational New Drugs which confirmed mitazalimab's manageable safety profile and favorable pharmacokinetic profile, further supporting ongoing and future mitazalimab trials.
ATOR-1017
- Alligator presented a poster at the SITC Annual Meeting in November highlighting new results from the Phase 1 first-in-human clinical trial of ATOR-1017, showing it to be safe and well tolerated at doses up to 900 mg with an excellent clinical profile as a potential best-in-class asset. These data warrant further development of ATOR-1017 in combination with other therapeutic approaches in solid tumors and Alligator is now seeking a partner to support this.
ALG.APV-527
- On September 19, Alligator and Aptevo Therapeutics announced that the US Food and Drug Administration (FDA) had issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND) allowing the companies to begin preparations for a multi-center Phase 1 trial in the US.
- In November, Alligator and Aptevo Therapeutics announced the publication of a peer-reviewed article in Molecular Cancer Therapeutics highlighting preclinical data demonstrating a positive safety and anti-tumor profile in both in vitro and in vivo studies for ALG.APV-527.
AC101 (HLX22)
- In November, Alligator announced that Shanghai Henlius Biotech, Inc. received investigational new drug (IND) approval from China's National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22) in combination with anti-PD-1 antibody serplulimab, trastuzumab and chemotherapy in gastric cancer.
Neo-X-Prime™
- In November, Alligator announced the publication of a peer-reviewed article in the Journal for ImmunoTherapy of Cancer highlighting how bispecific Neo-X-Prime™ antibodies targeting CD40 and tumor-associated antigens (TAA) represent a promising novel treatment modality with the potential to meet key needs in immuno-oncology.
Significant events after the end of the period:
Research Collaboration and License Agreement with Orion Corporation
- In early January, Alligator and Orion announced the initiation of the second project of their collaboration to develop a bispecific antibody with potential applications in solid tumors.
Mitazalimab
- On January 2, Alligator announced positive interim results from the OPTIMIZE-1 Phase 1b/2 trial in pancreatic cancer, with efficacy analysis showing mitazalimab combined with mFOLFIRINOX resulted in a 52 % Objective Response Rate.
- The data confirm the safety of mitazalimab combined with mFOLFIRINOX as previously reported.
- Alligator plans to discuss these strong results with regulators in H2 2023 once the interim PFS data are reported, to explore potential accelerated development and approval pathway in the US and Europe.
Outlook into 2023
Alligator continues to advance its clinical pipeline with an additional interim data readout from the ongoing Phase 2 OPTIMIZE-1 study planned for mid-2023. This readout will include efficacy evaluation with Progression Free Survival (PFS) data. Furthermore, preparatory work for OPTIMIZE-2, a second Phase 2 clinical study with mitazalimab, is ongoing and we expect to receive an IND clearance from the regulators in H1 2023. Looking into the second half of 2023, we aim to enter discussions with the FDA on the best regulatory path for mitazalimab in combination with mFOLFIRINOX in first-line pancreatic cancer with ORR and PFS as the basis for discussions.
FINANCIAL SUMMARY FOR Q4 2022 AND FULL YEAR 2022
The financial summaries for the quarterly periods ending December 31st, 2022 and December 31st, 2021 are presented below.
| All amounts in MSEK, unless specified |
October – December 2022 | October – December 2021 |
| Net Sales | 20.1 | 5.2 |
| Operating profit/loss | -52.6 | -36.9 |
| Profit/loss for the period | -53.3 | -36.8 |
| Earnings per share (SEK) before and after dilution |
-0.24 | -0.41* |
| Cash Flow | -49.8 | 198.8 |
| Cash & Cash Equivalents | 97.3 | 278.1 |
The financial summaries for the full year ending December 31st, 2022 and December 31st, 2021 are presented below.
| All amounts in MSEK, unless specified |
January – December 2022 | January – December 2021 |
| Net Sales | 35.7 | 12.9 |
| Operating profit/loss | -192.8 | -141.6 |
| Profit/loss for the period | -193.4 | -141.7 |
| Earnings per share (SEK) before and after dilution |
-0.88 | -1.58* |
| Cash Flow | -180.9 | 174.7 |
| Cash & Cash Equivalents | 97.3 | 278.1 |
*) Previous periods have been adjusted, see Note 8, page 21 in the attached report.
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 today at 2:00 p.m. CET / 8:00 a.m. ET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q4 interim report, which will be followed by a Q&A chat session. The call will be held in English.
The livestream call can be accessed through Alligator’s website, LinkedIn or Youtube.
The information was submitted for publication, through the agency of the contact person set out below, at 08:00 a.m. CET on February 10, 2023.