On September 13, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen1: ONXEO), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), reported its consolidated half-year financial results to June 30, 2022 and provides an update on its activities (Press release, Onxeo, SEP 13, 2022, View Source [SID1234619503]).
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Dr. Shefali Agarwal, President and CEO of Onxeo, said: "This first half of the year has been an opportunity for Onxeo to undergo profound transformations, both in its organization and governance, with the aim of refocusing our clinical research efforts and strengthening our presence globally. This new focus has been made possible due to the support of our long-term shareholders Invus and Financière de la Montagne, who participated in our latest capital increase, which secures our operations until the second quarter of 2023.
One of the important achievements of our thoughtful development plan was the very first approval by the Food and Drug Administration (FDA) of the initial Investigational New Drug (IND) application for AsiDNA, an encouraging progress since the formation of our U.S. team this April. We expect to initiate a clinical trial based on the safe to proceed letter from FDA in the second half of 2022 at multiple U.S. clinical sites.
We also continue our two Phase 1b/2 clinical trials, Revocan and the clinical trial targeting recurrent high-grade glioma in children, sponsored respectively by our partners Gustave Roussy and the Institut Curie.
Finally, we have continued our efforts to optimize our OX400 family of compounds and other preclinical assets, with the objective of entering clinical trials for a first drug candidate in 2023 and thereafter."
FINANCIAL RESULTS FOR THE FIRST HALF OF 2022
Consolidated income statement (IFRS)
In thousands of euros
30/06/2022
30/06/2021
Revenues, of which:
0
589
Recurring revenues
0
0
Non-recurring revenues
0
589
Operating expenses, including:
(9,631)
(5,367)
R&D expenditure
(4,107)
(1,389)
Other current operating income
282
33
Current operating income
(9,348)
(4,745)
Other non-recurring operating income and expenses
385
198
Income from companies accounted for by the equity method
Operating profit after share of profit of associates
(8,963)
(4,547)
Financial result
(2,448)
(238)
Income tax expense
(55)
15
Net income
(11,471)
(4,770)
The half-year accounts as of June 30, 2022, drawn up according to IFRS standards and approved by the Board of Directors on September 13,22, have not been audited.
The Group has not recorded any consolidated revenues for the period ended June 30, 2022.
Operating expenses amounted to €9.6 million. The increase compared to €5.4 million in 2021 is mainly due to the evolution of the Company’s headcount in France and the United States and to the growth in R&D expenses. The latter increased by €1.4 million in the first half of 2022 to reach €4.1 million, mainly due to industrial development and manufacturing of clinical batches for AsiDNA. This increase was partially offset by a decrease in general and administrative expenses.
Financial result was a loss of €2.4 million and consisted mainly of the interest expense on the bond loan with SWK Holdings.
The Group’s total net loss was thus €11.5 million in the first half of 2022, compared with a loss of €4.8 million for the same period in 2021.
CASH POSITION AT JUNE 30, 2022
At June 30, 2022, the Group’s cash position was €26.9 million, compared to €17.9 million euros at December 31, 2021. This increase comes mainly from the issue of new shares (€8 million) and the convertible bond issue (€4 million), carried out during the first half of the year. These resources provide the Company with sufficient visibility to carry out its projects, including the expansion of the clinical development of AsiDNA and the continuation of the preclinical development of the OX400 compounds, until Q2 2023.
HIGHLIGHTS OF THE FIRST HALF OF 2022 AND RECENT DEVELOPMENTS
AsiDNA
The Food and Drug Administration (FDA) approved the initial Investigational New Drug (IND) application for AsiDNA at the end of June, allowing Onxeo to initiate a multicenter Phase 1b/2 trial to evaluate the safety and efficacy of AsiDNA in combination with the PARP inhibitor Olaparib in patients with epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed despite initial treatment with PARP inhibitors. This is the first IND filed by Onxeo since the arrival of the U.S. team in April 2022. The Company plans to launch this clinical trial in the second half of 2022 at 3 to 5 potential clinical sites in the United States.
Two trials conducted in collaboration with two academic research centers of excellence in oncology continued during the semester:
The phase 1b/2 Revocan trial evaluating the addition of AsiDNA to combat resistance to PARP inhibitors in the 2nd line maintenance treatment of recurrent ovarian cancer for which Gustave Roussy is the study sponsor. Due to a slower than expected patient recruitment rate, first results are now expected in the second half of 2022.
The Phase 1b/2 trial evaluating AsiDNA in combination with radiotherapy in the treatment of recurrent high-grade glioma in children ("Children" study), an indication with a particularly poor prognosis. The Institut Curie is the sponsor of this study, which is being conducted by the European ITCC consortium2, and is funded by the European Fight Kids Cancer program. Treatment of a first patient has been announced for August 2022.
Onxeo presented innovative new data at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies 2022 Congress on March 7-8, 2022, confirming the relevance of combining AsiDNA with PARP inhibitors (PARPi) in the treatment of tumors with an active homologous recombination pathway to overcome intrinsic or acquired resistance in the clinical setting.
The Company also presented new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held on April 8-13, 2022, demonstrating AsiDNA’s ability to overcome tumor resistance and protect against the toxicity of cancer treatments. Specifically, these data support AsiDNA’s ability to overcome resistance to tyrosine kinase inhibitors in lung cancer models and to protect healthy cells when combined with conventional anti-tumor treatments.
OX400
During the first half of 2022, Onxeo continued the optimization of OX401, the first compound of the OX400 family from its PlatON platform, to improve its action on the PARP protein, involved in tumor DNA repair pathways, and its activation of the anti-tumor immune response via the cGAS-STING pathway. The Group expects to select the optimized compound and enter preclinical development in 2022.
Governance
On January 3, 2022, Onxeo announced the appointment of Julien Miara as interim Chief Executive Officer, replacing Judith Greciet. Mrs Greciet left the Company during the first half of 2022.
On April 7, 2022, Dr. Shefali Agarwal succeeded Julien Miara and was appointed President and CEO of Onxeo.
The Combined General Meeting of June 15, 2022 appointed Khalil Barrage, Managing Director at Invus, as a new director for three years. The shareholders also renewed the term of office of GammaX Corporate Advisory, represented by Jacques Mallet, for an additional 3-year term. Danielle Guyot-Caparros, whose third term of office expired at this General Meeting, did not wish to renew her mandate.
As a result of these changes, the Board of Directors has now eight members, out of which four are independent.
Delisting from Copenhagen’s First North Market
The Company has applied for and received, by letter dated August 29, approval from Nasdaq in Copenhagen for the Onxeo shares to be withdrawn from trading on the Nasdaq First North Growth market. In accordance with Nasdaq regulations, the Danish Onxeo shares will remain tradable on the Nasdaq First North Growth market, subject to the availability of counterparties, for a period until November 8, 2022. The company maintains its primary listing on Euronext Growth Paris.
OUTLOOK
The Company continues to pursue its strategy based on the development of its therapeutic innovations up to proof of concept in humans, with the following projected activities:
AsiDNA
Initiation of patient enrolment in a U.S. Phase 1b/2 clinical trial;
First results (part 1b) of the REVOCAN study expected from the study sponsor, Gustave Roussy;
Continuation of the Children study (phase 1b/2) conducted by the European ITCC consortium, with the support of the Institut Curie.
OX400
Optimization of the most promising OX400 compound;
Preclinical proof of concept in vitro and in vivo in combination with immunotherapies;
Development of the translational and regulatory plan for entry into the clinic in 2023.
platON
Continued evaluation and optimization of new compounds.
The 2022 half-year financial report is available on the Company’s website.