Promising safety data for ATOR-1015
“With the new strategy announced in early April, we have put a stronger focus on Alligator’s clinical development portfolio. ATOR-1015 has received a great deal of attention in connection with the positive interim data presented at AACR and ASCO, the world’s two largest oncology conferences. We have also worked actively with business development and signed a research agreement with Scandion Oncology during the period, while our collaboration with Biotheus developed well and led to an additional milestone payment. The Covid-19 pandemic has been stressful but has not led to any serious delays in the clinical projects. We are now looking forward to an exciting second half of 2020 for Alligator“, commented CEO Per Norlén.
Significant events April-June
• ATOR-1015: The Phase I clinical study progressed well with eleven dose levels evaluated for initial safety. Interim data from up to 21 cancer patients was presented at the oncology conferences AACR and ASCO, showing a promising safety and tolerability for ATOR-1015. Currently, patients are given doses of 750 mg, approximately 12.5 mg/kg, every two weeks.
• Mitazalimab: A preclinical collaboration agreement was signed with the Danish biotech company Scandion Oncology. The collaboration will further validate
mitazalimab’s potential in combination therapy with diverse chemotherapeutic agents. Preparations are ongoing for a clinical phase II study with the aim to submit a CTA before year-end.
• ATOR-1017: A first patent within the development program was approved by the U.S. Patent Office, and its earliest expiry year is 2037.
• ALG.APV-527: Preclinical data, supporting that ALG.APV-527 has the potential to induce a strong anti-tumor immune response without systemic toxicity, was presented at PEGS Interactive Virtual Summit.
• Biotheus agreement: Our collaboration partner Biotheus has chosen to continue the antibody collaboration after a thorough technical evaluation, resulting in a payment to Alligator of USD 0.5 million.
• New CFO: Marie Svensson was appointed as the new CFO starting September 1, 2020.
• Strategy: A strategic decision was taken to strengthen clinical focus with the aim to build value of the clinical drug candidates, while reducing preclinical expenses including a 20% reduction in workforce. The adjustments will extend Alligator’s cash runway into the fourth quarter of 2021.
• Effects of Covid-19: Patient recruitment in the Phase I studies was temporarily paused in March and April 2020 due to the Covid-19 pandemic but has been resumed. Approved governmental subsidies amount to SEK 1.5 to 2.0 million.
• Net sales, SEK 4.4 million (0.0).
• Operating result, SEK -34.7 million (-50.5).
• Result for the period, SEK -35.1 million (-49.3).
• Earnings per share before and after dilution, SEK -0.49 (-0.69).
• Cash flow for the period, SEK -33.2 million (-44.9).
• Cash and cash equivalents, incl. interest-bearing securities, SEK 169.8 million (358.2).
• Net sales, SEK 4.4 million (0.1).
• Operating result, SEK -79.6 million (-96.7).
• Result for the period, SEK -77.9 million (-93.7).
• Earnings per share before and after dilution, SEK -1.09 (-1.31).
• Cash flow for the period, SEK -27.7 million (-79.2). (See p. 17)
Read the complete report in the pdf below.
For further information, please contact:
Per Norlén, CEO, firstname.lastname@example.org, +46 46-540 82 00
Andreas Johannesson, Interim CFO, email@example.com, +46 46-540 82 00
Cecilia Hofvander, Director IR & Communications, firstname.lastname@example.org, + 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 1:00 p.m. CEST on July 13, 2020.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s pipeline includes five lead clinical and preclinical drug candidates: Mitazalimab, ATOR-1015, ATOR-1017, ALG.APV-527 (co-developed with Aptevo Therapeutics Inc.) and AC101 (in clinical development by Shanghai Henlius Biotech Inc.). Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit http://www.alligatorbioscience.com.