On September 28, 2023 Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO), hereafter "Valerio Therapeutics" 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, 2023, and provides an update on its activities (Press release, Valerio Therapeutics, SEP 28, 2023, View Source [SID1234635523]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Dr. Shefali Agarwal, President and CEO of Valerio Therapeutics, said: "The first half of 2023 was an important phase for our Company. By renaming ourselves Valerio Therapeutics, we highlighted our will to use innovative technologies such as DNA decoys to advance new anti-cancer treatments.
AsiDNATM, our first-in-class drug candidate, is currently being evaluated in an ongoing 1b/2 trial in the United State. This study is in combination with Olaparib in recurrent ovarian, breast and metastatic castration-resistant prostate cancer and the objective is to assess the safety and tolerability of the combination as well as to determine the recommended Phase 2 dose. Patient recruitment is progressing, and Top-line results are expected this year.
In parallel, AsiDNATM has also continued to be evaluated in two additional studies in collaboration with French academic research centers, the first one by Gustave Roussy to combat PARP inhibitor resistance in second-line maintenance treatment of recurrent ovarian cancer, and the second one by the Institut Curie in combination with radiotherapy in recurrent high-grade glioma in children.
Finally, our R&D efforts have been focused on the optimization of our PlatONTM platform and the development new therapeutic agents in oncology and other therapeutic agents. We now have a lead candidate from the OX400 compound family, VIO-01 (formerly OX425), a pan DNA repair decoy. This product works by abrogating several DNA repair pathways, inducing a drug-driven synthetic lethality without the need of a combined treatment. This potentially is first of its kind product with a broad applicability and thus represents a promising drug candidate to move forward to clinical development. We continue to explore new therapeutic pathways with PlatONTM and think that PROTACs (PROteolysis-TArgeting Chimeras) technology and other tumor specific targeting options may be a novel class presenting several potential benefits when combined with our DNA decoy molecules.
By all these progresses, Valerio Therapeutics is well positioned to rapidly advance breakthrough therapeutic candidates through Phase 2 development and, eventually, to contribute to the treatment of cancer patients globally. Additionally, we are also continuing active evaluation of business partnerships that can be synergistic to our pipeline and the team."
FINANCIAL RESULTS FOR THE FIRST HALF OF 2023
Consolidated income statement (IFRS)
In thousands of euros
June 30, 2023
June 30,2022
Revenues, of which:
0
0
Recurring revenues
0
0
Non-recurring revenues
0
0
Operating expenses, including:
(11,622)
(9,631)
R&D expenditure with third parties
(5,643)
(4,107)
Other current operating income
28
282
Current operating income
(11,594)
(9,348)
Other non-recurring operating income
0
385
Income from companies accounted for by the equity method
Operating income after share of profit of associates
(11,593)
(8,963)
Financial income
(50)
(2,448)
Income tax expense
0
(59)
Net income
(11,644)
(11,471)
The half-year accounts as of June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 28, 2023, have not been audited nor been the subject of a limited review; being remembered that a new auditor was appointed at the shareholders’ meeting held on 6 June 2023.
The Group did not record any consolidated revenues for the period ended June 30, 2023.
Operating expenses amounted to €11.6 million. The increase compared to €9.6 million in 2022 is related to the strengthening of the scientific teams, and to the growth in R&D expenses. The latter increased by €1.5 million in the first half of 2023 to reach €5.6 million, mainly due to industrial development and manufacturing of clinical batches for AsiDNATM.
The financial loss as of June 30, 2023, amounted to €50k compared to a loss of €2.4 million as of June 30, 2022, mainly due to the cost of the bond issue with SWK Holdings.
The Group’s total net loss was thus €11.6 million in the first half of 2023, compared with a loss of €11.4 million for the same period in 2022.
CASH POSITION AS OF JUNE 30, 2023
As of June 30, 2023, the Group’s cash position was €16.8 million, compared to €14.6 million as of December 31, 2022. This increase comes from a €12 million financing obtained on June 9, 2023, from the Company’s historical shareholders, Invus and Financière de la Montagne and a new investor, Agenus Inc. The net proceeds of this reserved share issue are intended for the development of VIO-01 (formerly OX425), both clinically and industrially, for ongoing and future clinical trials and more generally, to finance the Company’s current expenses.
Following the completion of the capital increase, Invus Public Equities LP and Financière de la Montagne held 28.5% and 19% of the Company’s capital respectively, based on a total of 154,364,273 shares. Agenus held 11.5% of the Company’s capital.
These resources provide the Company with sufficient visibility to carry out its projects, including the expansion of the clinical development of AsiDNATM and the continuation of the preclinical development of the platONTM compounds, including VIO-01, until the second quarter of 2024.
HIGHLIGHTS OF THE FIRST HALF OF 2023 AND RECENT DEVELOPMENTS
AsiDNATM
In the United States, the multi-center Phase 1b/2 study evaluating the safety and efficacy of AsiDNATM 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 was initiated in December 2022, and is currently ongoing, with 1 patient enrolled in the study. The plan is to continue enrollment in the dose escalation phase until the third quarter 2023, convene a Safety Monitoring Committee (SMC) to review the data and identify dose for expansion.
In addition, during the first half of the year 2023, Valerio Therapeutics continued supporting two investigator induced studies conducted in collaboration with two academic research centers of excellence in oncology:
– The Revocan phase 1b/2 trial evaluating the addition of AsiDNA to combat PARP inhibitor resistance in second-line maintenance treatment of recurrent ovarian cancer. Gustave Roussy is the promoter of this study. The pace of recruitment has been slower than expected and 15 patients have been enrolled in this first part of the study. The first interim analysis of 10 patients was conducted in the first half of 2023, showing a Disease Control Rate (DCR) of 70 %, an overall reduction in the percentage of CA125 (tumor marker) in responding patients, which serves as a proof of concept of the treatment with AsiDNATM.
– The Phase 1b/2 trial evaluating AsiDNATM in combination with radiotherapy in recurrent high-grade glioma in children, an indication with a particularly poor prognosis. The Institut Curie is the sponsor of this study, which is supported by a grant from the European Fight Kids Cancer program. The Company has announced the treatment of a first patient in August 2022, 7 patients were enrolled in this first part of the study, no data from the study has been disclosed yet.
VIO-01 (formerly OX425)
During the first half of 2023, the Company continued to optimize the OX400 pan-DDR DNA decoy family to improve its action on repair proteins, involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway.
VIO-01, formerly OX425, is a Pan-DDR DNA Decoy Targeting Multiple Proteins & Repair Pathways and represents the most optimal drug candidate selected to enter preclinical development. VIO-01 traps several DDR Proteins Inhibiting Different DNA Repair Pathways. VIO-01 reaches the nucleus and acts as a decoy for several DNA repair enzymes. It has an increased resistance to nucleases and plasmatic stability.
Valerio Therapeutics presented new preclinical data confirming the pan-DDR DNA decoy effect of VIO-01 and the high anti-tumor activity in tumor models independently from the homologous recombination repair status on April 19, 2023, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Also, the Company presented new preclinical data confirming VIO-01’s capability to abrogate several DNA repair pathways and induce a drug-driven synthetic lethality, without the need of a combined treatment.
3rd generation of PlatONTM platform
Valerio Therapeutics continued to optimize the PlatON platform to develop more potent assets coupled to innovative technologies, with the objective to combine PlaTON platform’s DNA decoys with the targeted protein degradation strategy offered by PROTACs (PROteolysis-TArgeting Chimeras) technology. PROTACs technology and other tumor specific targeting options may be a novel class of heterobifunctional molecules that can selectively degrade target proteins within cells. This approach offers several advantages over the other molecules involved in modulating the DNA damage response, such as increased selectivity and reduced toxicity. This specific strategy involves generating DecoyTAC combining our vectorized DNA decoy molecules capable of efficient cell penetration with a linker+E3 ligand promoting the complete degradation of the target proteins, thereby presenting a novel mechanism of action.
The exploration of the convergence of PROTACs and DNA Decoys aims to not only propose new therapeutic modalities against DDR proteins but also against transcription factor proteins that are challenging to target. Through these efforts, the Company strive to advance the field of oncology drug development and contribute to the treatment of cancer patients.
Governance and Corporate
The Annual General Meeting of June 6, 2023, renewed the terms of Financière de la Montagne, represented by Mr. Nicolas Trebouta, and Robert Coleman as directors for three years. As of the date of this report, the Board of Directors is composed of 7 members, 6 men and 1 woman, including 3 independent members.
The Annual General Meeting also approved the change of company name to Valerio Therapeutics. This name change was accompanied by a new identity designed to better represent Valerio Therapeutics’ ability to rapidly advance breakthrough therapeutic candidates through Phase 2 development, and to collaborate with partners for further development and commercialization. The ISIN code remained unchanged.
OUTLOOK
In 2023, the Company will continue to pursue its value creation strategy based on the development of its therapeutic innovations up to proof-of-concept studies in humans, and then generate revenues through agreements with other pharmaceutical companies capable of pursuing their development.
AsiDNA
Enrollment to continue in the U.S. phase 1b/2 trial in combination with Olaparib in ovarian, breast and prostate cancers to identify the RP2D in combination with Olaparib.
Clinical updates expected in the second half of 2023 from phase 1b/2 trials conducted in France and European Union under the sponsorship of academic centers:
REVOCAN trial with Gustave Roussy;
Pediatric trial in High-Grade Glioma with Institut Curie;
Submissions for publications in international scientific journals of the results of preclinical or clinical studies as part of the development plan to demonstrate the potential of AsiDNA.
VIO-01 (formerly OX425)
Finalization of the IND-enabling preclinical studies.
Preparation of an IND application with the FDA in second half-year 2023.
platON
Continued evaluation and optimization of PlatONTM platform and potential new drug candidates.
The 2023 half-year financial report is available on the Company’s website.