Onxeo Reports its Financial Results for the First Half of 2020 and Provides an Update on its …

  • The cash position of €19.6 million, which was strengthened in the first half of the year by two strategic transactions, provides financial visibility into Q1 2022
  • Patient inclusion process has started in the Phase 1b/2 REVOCAN study evaluating the effect of AsiDNA™ on resistance to niraparib and preliminary results are expected in early 2021
  • Topline results of the AsiDNA™ DRIIV-1b study in combination with chemotherapy are expected in late 2020/early 2021
  • Invus, new reference shareholder, has been coopted as a director of the Company

PARIS, Sept. 17, 2020 (GLOBE NEWSWIRE) — Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), in particular against rare or resistant cancers, today reported its consolidated financial results for the six months ended June 30, 2020, and provided an update on its activities.

Judith Greciet, CEO of Onxeo, said: “ The first half of 2020 has truly been extraordinary, with a pandemic that has directly or indirectly impacted the lives of every one of us. I would like to take this opportunity to thank all of our employees who have been able to adapt to this unprecedented context and whose mobilization and team spirit have made it possible to achieve an exceptional first half of the year in terms of preclinical and clinical development as well as financial performance. We are delighted that AsiDNA™‘s development is gaining momentum and that we are progressively moving closer to our strategic objectives: to finalize the DRIIV-1b study to confirm AsiDNA™‘s interest in combination with DNA breakers and to demonstrate AsiDNA™’s ability to abrogate the acquired resistance of tumors to certain targeted therapies. Indeed, while the efficacy of cancer treatments is increasingly improving, resistance is a real problem in the short and medium term and delaying or even preventing its emergence represents one of the major challenges in oncology today. This is the objective of REVOCAN, a phase 1b/2 study set up with Gustave Roussy, in which AsiDNA™ is being tested in patients with relapsed ovarian cancer showing signs of acquired resistance to niraparib treatment. The patient inclusion process in this study has started and, in accordance with our road map, we expect preliminary results as early as the first quarter of 2021.

“It is also important to note that, despite the highly uncertain environment in the financial markets, we have considerably strengthened Onxeo’s financial position with two major strategic transactions. In April, we received €6 million from our US partner Acrotech in consideration for the grant of additional exclusive rights to belinostat, and in early June, we completed a €7.3 million private placement with Financière de la Montagne, our historical shareholder, and Invus, a strategic international investor. In addition to reinforcing the financial visibility until the first quarter of 2022, well beyond the expected key clinical results, this operation has brought into the capital, with a seat on the Board of Directors, a second reference investor who is able to support the company’s growth strategy over the long term.

“Thus, the impact of Covid-19 on our activities remains limited to date and we remain fully mobilized to deliver tangible results and confirm the value of our assets”.

FINANCIAL RESULTS1 OF THE 1st HALF-YEAR 2020

Revenues for the first half of 2020 amounted to 1.1 million euros and consisted mainly of direct sales of Beleodaq® under the European Controlled Access Program (NPP), transferred to the partner Acrotech Biopharma as part of the agreement signed in early April, and to royalties on sales of Beleodaq® in the United States by Acrotech, used in full to repay the bond loan from SWK Holdings. These revenues have been recognized up to the date of the agreement signed with Acrotech, which explains the decrease compared to the recurring revenues of EUR 1.4 million recorded in H1 2019.

Operating expenses amounted to EUR 5.5 million in H1 2020, a significant decrease compared to the expenses recognized in H1 2019. This change is mainly due to completion in 2019 of industrial activities for clinical trial purposes relating to AsiDNA™.

The agreement concluded with Acrotech Biopharma on April 6, 2020 was analyzed under IFRS as a disposal of belinostat-related assets. This led to the recognition of the following items in other operating income and expenses (non-current):

  • A net income of 5,686 thousand euros corresponding to the transaction price of 6,116 thousand euro less the amount of future belinostat development costs to be borne by Onxeo estimated at 430 thousand euros.
  • An expense of 2,769 thousand euros corresponding to the net carrying amount of Beleodaq®/belinostat-related R&D assets.
  • In the context of the bond loan from SWK, an income of 7,171 thousand euros corresponding to the estimated royalties still to be received from the initial license2 as of the date of signature of the new agreement with Acrotech. These royalties will be entirely allocated to the repayment of the balance of the bond loan. Although this future income is booked upfront in accordance with IFRS, the interest expense relating to the bond loan from SWK will continue to be booked on an annual basis.

After taking into account the financial result and a tax related to the transaction with Acrotech, Onxeo reported a net profit of €5 million for the first half of 2020, compared to a loss of €8.5 million in 2019.

__________________
1 Limited review procedures have been performed on the interim financial statements. The review report was issued after the completion of the procedures required for the publication of the interim financial report.

2 In March 2019, Acrotech acquired from Spectrum Pharmaceuticals (SPPI) the license to belinostat for certain territories, including the United States, Canada, Mexico, and India. The new agreement grants Acrotech a royalty-free license to belinostat in all other territories.

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