· Decision to leverage OPTIMIZE-1 interim data before initiating OPTIMIZE-2 study in H1 2023
Lund, Sweden, July 12, 2022 – Alligator Bioscience (Nasdaq Stockholm: ATORX)
Alligator Progresses Clinical Programs Towards Key Readouts
“We continued to make encouraging clinical progress with our leading drug candidates this quarter and we are looking ahead to key readouts from our OPTIMIZE-1 and ATOR-1017 clinical trials due in the second half of the year. We also expanded our board with two new members whose appointments further strengthen the leadership of the Company. To preserve financial resources and optimize the chances of success of our upcoming mitazalimab OPTIMIZE-2 clinical trial, we decided to await the interim data of OPTIMIZE-1 to readout before initiating this additional clinical trial, which we now expect in H1 2023. The entire Alligator team has worked tirelessly to deliver the OPTIMIZE-1 interim data and ATOR-1017 data on time and is entirely dedicated to continue to generate industry-leading scientific data to further validate the quality of our three core platforms to deliver long-term returns to all our stakeholders."
Søren Bregenholt, CEO Alligator Bioscience AB
BUSINESS UPDATE
Clinical Pipeline:
Mitazalimab
- Considering the proximity in timing between the mitazalimab OPTIMIZE-1 interim data readout at the end of 2022 and the initially planned start of the mitazalimab OPTIMIZE-2 clinical trial, Alligator has decided to await the OPTIMIZE-1 interim data before initiating OPTIMIZE-2. This small adjustment will help derisk the overall OPTIMIZE-2 clinical trial by enabling the implementation of potential learnings from the OPTIMIZE-1 interim data.
ATOR-1017
- On April 1, Alligator announced the completion of the 600 mg dose cohort for the ATOR-1017 Phase 1 study (NCT04144842), and the start of patient enrollment and treatment for the 900 mg dose cohort.
- Following that announcement, Alligator presented a poster at the ASCO Annual Meeting in June outlining additional results from the Phase I trial demonstrating ATOR-1017 is safe and well-tolerated up to 600 mg and has shown indications of clinical benefit, including 45% of patients achieving stable disease, with the longest treatment duration being 16 months. Alligator also confirmed it was on track to report data from the 900 mg cohort in 2022.
Corporate:
- At the Annual General Meeting, Anders Ekblom, Graham Dixon, Hans-Peter Ostler, Eva Sjökvist Saers and Veronica Wallin were re-elected as board members, and Staffan Encrantz and Denise Goode were elected as new board members. Anders Ekblom was re-elected as Chairman of the board, and Hans-Peter Ostler was re-elected as Vice Chairman of the board.
FINANCIAL SUMMARY FOR Q2 2022 and H1 2022
The financial summaries for the quarterly periods ending June 30th 2022 and June 30th 2021 are presented below.
All amounts in MSEK, unless specified |
Q2 2022 |
Q2 2021* |
Net Sales |
5,2 |
3,8 |
|
|
|
Operating Expenses |
-51,3 |
-38,4 |
Operating profit/(loss) |
-45,9 |
-34,5 |
|
|
|
Profit/(loss) for the period |
-45,7 |
-35,0 |
|
|
|
Earnings per share (SEK) |
-0,21 |
-0,43 |
Weighted average number of shares |
220,584,878 |
81,835,729 |
|
|
|
Cash Flow |
-41,7 |
-34,0 |
Cash & Cash Equivalents |
192,9 |
109,7 |
The financial summaries for the half-yearly periods ending June 30th 2022 and June 30th 2021 are presented below.
All amounts in MSEK, unless specified |
H1 2022 |
H1 2021* |
Net Sales |
10,5 |
4,4 |
|
|
|
Operating Expenses |
-99,9 |
-71,7 |
Operating profit/(loss) |
-88,9 |
-67,0 |
|
|
|
Profit/(loss) for the period |
-88,8 |
-67,7 |
|
|
|
Earnings per share (SEK) |
-0,40 |
-0,83 |
Weighted average number of shares |
220,584,878 |
81,835,729 |
|
|
|
Cash Flow |
-85,5 |
6,4 |
Cash & Cash Equivalents |
192,9 |
109,7 |
*) Previous periods have been adjusted, see Note 8, page 20 in the attached report.
The full report is attached as PDF available on the company’s website: https://alligatorbioscience.se/en/investors/financial-reports/
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 46-540 82 00
Marie Svensson, CFO
E-mail: marie.svensson@alligatorbioscience.com
Phone: +46 46-540 82 03
This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on July 12, 2022.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s pipeline includes the two key assets mitazalimab, a CD40 agonist, and ATOR-1017, a 4-1BB agonist. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc. Alligator Bioscience’s shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden.
For more information, please visit alligatorbioscience.com.