Onxeo Reports Full-Year 2019 Financial Results and Provides Business Update
- Cash position of €5.7 million at December 31, 2019, combined with $6.6 million from new agreement with Acrotech, provide extended financial visibility into Q2 2021
- AsiDNA™ to advance to phase 1b/2 study REVOCAN in combination with niraparib in patients with relapsed ovarian cancer to evaluate effect on acquired resistance with preliminary data possibly by end 2020/early 2021
- Topline results from DRIIV-1b study of AsiDNA™ in combination with reference chemotherapy in multi-treated advanced solid tumors expected by end 2020
- Impact of Covid-19 on Company’s operations are limited, assuming the situation improves in Q3 2020
Paris (France), April 17, 2020 – 5.45 pm CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO - FR0010095596), (“Onxeo”, “the Company” or “the Group”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, today reported its consolidated financial results for the fiscal ending December 31, 2019, and provided a business update.
Judith Greciet, Chief Executive Officer of Onxeo, said: “During 2019, Onxeo concentrated its operational efforts on its high-potential DDR-related development programs. As a result, AsiDNA™, our lead drug candidate, reached several major clinical milestones during the year. First of all, we demonstrated in the DRIIV-1 study that our differentiated DDR inhibitor was active in man by IV route, while being well tolerated. Based on this promising data and given its mode of action particularly well suited for use in combination, we initiated in mid-2019 DRIIV-1b, the first combination study of AsiDNA™ with a reference chemotherapy in patients with advanced multi-treated cancers. The first part of DRIIV-1b demonstrated that AsiDNA™ in combination with carboplatin is well-tolerated and two out of the first three patients had their disease “controlled”, with a tumor progression that stopped for a period longer than that of previous treatments. Topline results of the second part of the study, combining AsiDNA™ with carboplatin and paclitaxel, should be available by end 2020.
Importantly, our R&D teams focused on the much differentiated ability of AsiDNA™ to overcome the acquired resistance of tumors to PARP inhibitors (PARPi), a major class of targeted therapies with, unfortunately, a decreasing efficacy over time due to tumors cells ability to resist treatment. In January 2020, we announced having entered into a Clinical Research Agreement with Gustave Roussy to conduct the REVOCAN phase 1b/2 study designed to evaluate the effect of AsiDNA™ on the acquired resistance to niraparib used in the 2nd line maintenance treatment of relapsed ovarian cancer. Our plan is to obtain preliminary results by year-end or early next year. If positive, this first study would represent a very significant value catalyst, positioning AsiDNA™ as an essential treatment option to stop acquired resistance to PARPi.
In parallel, we advanced the preclinical development of OX401, our new drug candidate designed as a next-generation PARPi that places Onxeo at the crossroads of DNA Damage Response and immuno oncology, the two most attractive domains in cancer treatment. We expect preclinical proof of concept of this exciting drug candidate this year.
Besides, we are pleased to have reached an exclusive agreement with Acrotech Biopharma in the form of a $6.6 million payment in exchange for exclusive rights on belinostat, in addition to the ones Acrotech already had. This transaction extends our cash runway into Q2 2021 and consolidates our strategic transition to a company focused in the domain of tumor DNA Damage Response, with compelling assets, especially to address the major challenge in oncology which is the tumor resistance to treatments.
Lastly, we are all facing the exceptional situation resulting from the Covid-19 pandemic. We had business continuation measures in place and, since day 1 of confinement, were able to maintain all teams’ activity, mostly working from home. To date, the impact on our activities and timelines has been kept quite minimal. Of course, we are managing the situation closely and continuously but the final impact will only be known once we have more visibility on how and when the situation returns to normal. “