This extensive and ambitious R&D program reflects the significant potential of our candidates in multiple combinations and therapeutic areas. Finally, the OX400 candidates have confirmed in preclinical studies their action on tumor metabolism and the immune system, presaging promising clinical combinations with immunotherapies. Over the past twelve months, we have also significantly strengthened Onxeo’s financial and shareholder structure. Invus, an international investor specializing in biotechnology, has joined Financière de la Montagne in the capital and on the Board of Directors of the Company. Their support has contributed to extend our financial horizon to the end of 2022 – well beyond the major clinical milestones expected in the next 18 months – and validates our strategy to expand the clinical and industrial development of our candidates.”
On the first axis, the positive efficacy signals obtained in DRIIV-1b, combining AsiDNA™ with reference chemotherapies, have enabled the preparation of a randomized phase 2 trial in lung cancer. Its adaptive design would allow it to be converted into a pivotal study based on initial positive results. Enrolment will start in the second half of 2021, as soon as regulatory approval is obtained. We have also initiated a Phase 1b/2 pediatric program with the Curie Institute in recurrent high-grade glioma, a brain cancer with a poor prognosis, against which the combination of AsiDNA™ with radiotherapy could offer an efficacy gain. Judith Greciet, Chief Executive Officer of Onxeo, declared: “2020 was marked for all by an unprecedented health crisis. Yet it will have allowed Onxeo to demonstrate the resilience of its teams and strategy. The clinical program for AsiDNA™, our lead candidate, made very significant progress in 2020 on its two development axes, synergy of efficacy with DNA breakers as radio or chemotherapy, and the fight against tumor resistance to targeted therapies.
In the fight against resistance to targeted therapies, the Phase 1b/2 Revocan study, which is evaluating the effect of AsiDNA™ on resistance to a PARP inhibitor in ovarian cancer, began in late 2020 and patient enrollment is ongoing. This study is sponsored by Gustave Roussy who leads its management and we expect to receive preliminary results from the first group of patients during the second half of the year. In addition, recent results presented at AACR 2021 confirm the effect of AsiDNA™ on drug-tolerant cells, one of the causes of resistance to targeted therapies such as PARP, KRAS or tyrosine kinase inhibitors. These results provide a strong rationale to consider an expansion of the clinical development of AsiDNA™ in other very high potential combinations. PARIS, April 21, 2021 (GLOBE NEWSWIRE) — Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, today reported its consolidated financial results for the fiscal ending December 31, 2020, and provided a business update.
Revenues for the year 2020 amounted to €1.8 million and include: €1.1 million in recurring revenue corresponding to sales of Beleodaq® under the European Named Patient Program (NPP) and royalties on sales of Beleodaq® in the United States by the partner Acrotech Biopharma. Its decrease from €3.5 million in 2019 is explained by the transfer of this activity to Acrotech as part of the licensing agreement signed in early April 2020.€0.7 million in non-recurring revenue, comprising contractual lump-sum royalties under the business transfer agreement signed in 2017 with Vectans Pharma. The 2020 consolidated accounts were approved by the board of directors on April 21, 2021. The audit procedures on the consolidated accounts have been carried out. The certification report is in the process of being issued.
Consolidated income statement (IFRS)In thousands of euros 12/31/202012/31/2019Revenues, of which: Recurring revenues Non-recurring revenues1,7761,0776994,2893,455833Operating expenses, of which: R&D expenses (9,803)(3,946)(14,178)(7,718)Other current operating income21395Current operating income / (loss)(7,814)(9,794)Other operating income and expenses10,008(24,543)Share of profit from equity affiliates (39)Operating income/(loss) after share of profit from equity affiliates2,194(34,376)Financial income/(loss)(347)(1,677)Income tax(757)2,324Net profit/loss1,089(33,728) FINANCIAL HIGHLIGHTS FOR 2020
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