- Patient enrolment for OPTIMIZE-1 Phase 2 study ahead of schedule with top-line data now brought forward to Q1 2024 and interim data on track for Q4 2022
- ATOR-1017 Phase 1 study data shows a strong clinical foundation and supports further development
- Preparations underway for ALG.APV-527 Phase 1 study following IND approval by the FDA
Lund, Sweden, October 20, 2022 – Alligator Bioscience AB (Nasdaq Stockholm: ATORX)
Alligator Continues Progress in Key Clinical Programs
“The Alligator team has worked with dedication through the last months to continue to deliver on our commitment to develop meaningful therapies for patients with hard-to-treat cancer, while creating value for our stakeholders and shareholders. We have announced promising clinical results and achieved clear progress across our development programs. Our OPTIMIZE-1 Phase 2 study with our lead asset mitazalimab has seen a significant acceleration in patient recruitment allowing us to bring the top-line read-out forward by nine months. We announced the successful conclusion of the Phase 1 study in our second candidate ATOR-1017, confirming previously announced signs of clinical benefit. We are now looking for a partner to embark on the next phase of its development. Moreover, we are moving towards a new Phase 1 study in the US having received IND approval by the FDA for ALG.APV-527, which we are co-developing with Aptevo Therapeutics. This positive momentum puts us in a strong position to achieve our next milestones in the months ahead.”
Søren Bregenholt, CEO Alligator Bioscience AB
BUSINESS UPDATE
Clinical Pipeline:
Mitazalimab
- On September 14, Alligator announced the presentation of additional data from the Phase 1b dose escalation of the OPTIMIZE-1 study, which confirmed the pharmacological activity of mitazalimab in combination with mFOLFIRINOX and was found to be safe and well tolerated.
- Patient enrolment for Phase 2 is ongoing at sites in Europe and has experienced a significant acceleration. Top-line data is now due in Q1 2024, nine months sooner than originally anticipated with the primary endpoint to show efficacy in patients with pancreatic cancer as per Response Evaluation Criteria in Solid Tumors (RECIST)-defined overall response rate (ORR).
- Interim efficacy read-out expected in Q4 2022, which will be used to optimize the design of the upcoming OPTIMIZE-2 clinical trial.
ATOR-1017
- On September 30, Alligator announced positive safety data from the 900 mg dose cohort in the ATOR-1017 Phase 1 dose escalation study in patients with advanced solid malignancies. Stable disease as best tumor response reconfirms previously reported signs of clinical benefit. This Phase 1 study is fully enrolled and has successfully fulfilled its purpose. Alligator will now seek a partner to support the continued clinical development of ATOR-1017.
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), and the companies are now moving towards initiating a multi-center Phase 1 trial in the US.
Corporate:
- As a testament to Alligator's CD40 expertise, senior staff from the company were invited to present at various prestige medical and scientific conferences, including the World Bispecific Summit in Boston and Immuno UK in London.
FINANCIAL SUMMARY FOR Q3 2022 AND YEAR-TO-DATE 2022
The financial summaries for the quarterly periods ending September 30th, 2022 and September 30th, 2021 are presented below.
| All amounts in MSEK, unless specified |
July– September 2022 | July– September 2021 |
| Net Sales | 5.1 | 3.3 |
| Operating profit/loss | -51.4 | -37.7 |
| Profit/loss for the period | -51.4 | -37.2 |
| Earnings per share (SEK) before and after dilution |
-0.23 | -0.45* |
| Cash Flow | -45.6 | -30.4 |
| Cash & Cash Equivalents | 147.4 | 79.3 |
The financial summaries for the year-to-date periods ending September 30, 2022 and September 30, 2021 are presented below.
| All amounts in MSEK, unless specified |
January – September 2022 | January – September 2021 |
| Net Sales | 15.6 | 7.7 |
| Operating profit/loss | -140.3 | -104.7 |
| Profit/loss for the period | -140.1 | -104.9 |
| Earnings per share (SEK) before and after dilution |
-0.64 | -1.26* |
| Cash Flow | -131.0 | -24.0 |
| Cash & Cash Equivalents | 147.4 | 79.3 |
*) Previous periods have been adjusted, see Note 8, page 20 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 3:00 p.m. CET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q3 interim report, which will be followed by a Q&A session. The call will be held in English. All necessary information to listen-in is available on the following link: https://financialhearings.com/event/44199.
The information was submitted for publication, through the agency of the contact person set out below, at 08:00 a.m. CET on October 20, 2022.