The Phase I study with ATOR-1017 has progressed exceptionally well and in August we presented interim data that showed a good safety profile at clinically relevant dose levels. The dose evaluation will continue with yet higher doses and we expect to present safety and potentially efficacy data from the entire study in the spring of 2021. At the same time, we have shown strong Proof of Mechanism data for mitazalimab, while the ATOR-1015 program reported side effects at high dose levels.The nature of the reactions have lead to a need to re-design the planned clinical trial in malignant melanoma and to perform additional preclinical investigations. We will now focus our clinical investments to ATOR-1017 and mitazalimab. Both programs have first-in-class potential, and will move into clinical Phase II during 2021", commented CEO Per Norlén.
SIGNIFICANT EVENTS JULY – SEPTEMBER
Mitazalimab:
- Positive biomarker data demonstrating Proof of Mechanism in clinical Phase I study performed by Janssen.
- Clinical development program defined. The CTA for the upcoming Phase II study in pancreatic cancer is scheduled to be submitted in December 2020.
ATOR-1015:
- Revised plan due to further evaluation of doses and adverse reactions, leading to delay of Phase Ib.
- US composition of matter patent granted.
ATOR-1017:
- Encouraging emerging safety data at clinically relevant dose levels in the ongoing Phase I study.
Preclinical:
- Neo-X-Prime: New unique drug concept for tumorspecific treatment launched at 11th World Bispecific Summit.
Other:
- Gayle Mills appointed Chief Business Officer.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD
Clinical focus on ATOR-1017 and mitazalimab:
- Preparations to bring ATOR-1017 and mitazalimab to Phase II efficacy studies in 2021.
- ATOR-1015: A partner will be sought for further clinical studies.
FINANCIAL SUMMARY
July-September 2020
- Net sales, SEK 0.0 million (4.3).
- Operating result, SEK -30.6 million (-58.5).
- Result for the period, SEK -30.8 million (-56.6).
- Earnings per share before and after dilution, SEK -0.43 (-0.79).
- Cash flow for the period, SEK -32.7 million (-47.3).
- Cash and cash equivalents, incl. interest-bearing securities, SEK 137.0 million (302.2)
January-September 2020
- Net sales, SEK 4.4 million (4.4).
- Operating result, SEK -110.2 million (-155.2).
- Result for the period, SEK -108.8 million (-150.3).
- Earnings per share before and after dilution, SEK-1.52 (-2.11).
- Cash flow for the period, SEK 42.6 million (-27.8).
During the first quarter, the holdings in corporate bonds and interest funds were divested, which had a positive effect on cash flow.
Read the complete report in the pdf below.
Alligator will host a conference call today at 2:00 p.m. CEST for investors, analysts and media, where CEO Per Norlén will present and comment on the Q3 interim report and the focus of the clinical operations. The conference will be held in English. All necessary information to listen-in and ask questions are available on the following link: https://financialhearings.com/event/12459.
For further information, please contact:
Per Norlén, CEO, per.norlen@alligatorbioscience.com, +46 46-540 82 00
Marie Svensson, CFO, marie.svensson@alligatorbioscience.com, +46 46-540 82 03
Cecilia Hofvander, Director IR & Communications, cecilia.hofvander@alligatorbioscience.com, + 46 46-540 82 06
Alligator Bioscience AB (publ) 556597-8201
Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden.
Phone +46 46-540 82 00
The information was submitted for publication, through the agency of the contact persons set out above, at 8:00 a.m. CEST on October 22, 2020.
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 ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets; ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immuno-therapy: Neo-X-Prime. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.