OPM Achieved Several Major Scientific and Regulatory Milestones as Part of the LARKIN Program, Supported With Funding By The Michael J. Fox Foundation for Parkinson's Research (MJFF)

• MJFF confirms its support to the program with the payment of an additional funding tranche
• Successful micronization of the active pharmaceutical ingredient and manufacturing of the first technical batches of OPM-201 tablets
• European Medicines Agency (EMA) support for OPM’s proposed long-term toxicology strategy
• Preparation of the next regulatory and clinical development steps for OPM-201, with the objective of initiating a Phase 1b trial in patients with Parkinson’s disease in 2027

Regulatory News:

Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker symbol: ALOPM), a biopharmaceutical company specializing in precision medicine, today announced several strategic advances in the development of OPM-201, its LRRK2 kinase inhibitor for the treatment of Parkinson’s disease.

These advances come six months after the launch of the LARKIN program, supported by a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) through its Therapeutic Pipeline Program (TPP) which supports promising Parkinson’s therapies from preclinical research through clinical testing. This funding notably supports the manufacturing of the drug product required for the next stages of clinical development, as well as the long-term toxicology program for OPM-201.

Since the launch of the LARKIN program, OPM has achieved several key milestones in pharmaceutical manufacturing, non-clinical development and regulatory preparation, in line with the objectives of the LARKIN program. MJFF continues to support the program by liberating an additional funding tranche.

Key manufacturing milestones achieved in preparation for Phase 1b

Pharmaceutical development activities conducted with the Contract Development and Manufacturing Organization (CDMO) selected by OPM have progressed significantly.

Micronization of the OPM-201 active pharmaceutical ingredient (API) has been completed, and feasibility batches followed by technical batches of the drug product, comprising active and placebo tablets, have been successfully manufactured and met the quality criteria assessed during production. The CDMO quality audit has also been completed.

These advances now enable OPM to proceed with the transfer of analytical methods and prepare for the GMP manufacturing of tablets to be used in the future Phase 1b clinical trial.

OPM advances the preclinical development required for future clinical stages

A key regulatory milestone has also been achieved in preparation for the long-term development of OPM-201. Following a scientific advice request submitted by OPM in April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) endorsed on July 23, 2026, the regulatory long-term toxicology study plan proposed by OPM to support the clinical development of OPM-201.

A contract research organization has been selected to conduct this GLP study. The main phase of the study is expected to begin in the first half of 2027.

In parallel, a comparative metabolism study of OPM-201 in human hepatocytes and hepatocytes from various preclinical species has been completed. The results provide additional data supporting the toxicology strategy and the preparation of upcoming regulatory interactions.

Active preparation for the next clinical stage

In parallel, OPM continues to prepare for the Phase 1b trial of OPM-201 in patients with Parkinson’s disease. In-depth pharmacokinetic/pharmacodynamic modeling is underway based on data generated in the Phase 1 study in healthy volunteers. This work is intended to optimize dose selection and the dosing regimen for the next clinical trial.

This work will notably support upcoming interactions with the U.S. Food and Drug Administration (FDA). OPM is currently preparing a pre-IND meeting request, with the objective of discussing the dose strategy and dosing regimen for the Phase 1b trial. IND submission is currently planned for early 2027.

Philippe Genne, co-founder, President and Chief Executive Officer of OPM, said: “Six months after the launch of the LARKIN program with the support of The Michael J. Fox Foundation, we have achieved several key milestones in the development of OPM-201. Our objective is now to maintain this momentum as we prepare for the evaluation of OPM-201 in patients with Parkinson’s disease in 2027. The LARKIN program remains on budget, and on August 27, 2026, OPM received a second payment from The Michael J. Fox Foundation following the achievement of the milestones defined under the program. We thank the Foundation for its continued confidence and for its commitment to patients living with Parkinson’s disease.”

Dr. Jan Hoflack, co-founder and Chief Scientific Officer of OPM, added: “The progress achieved over the past six months strengthens our confidence in the development path of OPM-201. The manufacturing of the first technical batches, together with the CHMP’s scientific advice on our long-term toxicology strategy, represent important milestones in supporting the continued development of the candidate. In parallel, our teams are actively preparing for the next clinical phase, which will enable us to further characterize OPM-201 and evaluate it in patients with Parkinson’s disease. All this work is aimed at building a robust development program designed to fully assess the potential of OPM-201 as a selective LRRK2 inhibitor.”

About OPM-201

OPM-201 is a macrocyclic inhibitor of the LRRK2 kinase derived from Oncodesign Precision Medicine’s Nanocyclix^® platform. LRRK2 is an important therapeutic target in Parkinson’s disease, particularly in certain genetic forms of the disease. Initiated in 2011 and developed through several partnerships with companies specializing in neurological diseases, the program was advanced internally by Oncodesign from 2017 before entering into a collaboration with Servier in 2019. This collaboration led to the identification of a drug candidate in 2021, followed by preclinical and CMC development activities. A first Phase 1 clinical trial in healthy volunteers subsequently demonstrated a favorable tolerability profile, with no serious adverse events observed, as well as LRRK2 target engagement in volunteers who received the highest dose, supporting the potential of OPM-201 as a “best-in-class” candidate. OPM regained full rights to the program from Servier in December 2024 and is now responsible for its development. In February 2026, OPM-201 was also selected by The Michael J. Fox Foundation to receive funding through its Therapeutic Pipeline Program.

About Parkinson’s disease

Parkinson’s disease is a progressive neurodegenerative disorder affecting 1% of the population over the age of 60. The disease, which affected nearly 12 million people worldwide in 2021, is characterized by the progressive loss of dopaminergic neurons. The LRRK2 gene is a major therapeutic target in Parkinson’s disease. Activating mutations in the LRRK2 gene are associated with hereditary forms of Parkinson’s disease. Along with alpha-synuclein, LRRK2 is one of the few targets considered to have the potential to modify the course of the disease. Current treatments are largely symptomatic and aim to increase dopamine levels in the vicinity of the remaining dopaminergic neurons.

About Oncodesign Precision Medicine (OPM)

Oncodesign Precision Medicine (OPM), founded in 2022, is a biopharmaceutical company specializing in precision medicine, dedicated to discovering treatments for resistant and metastatic cancers.

OPM currently has two kinase inhibitors in clinical phase:

1. OPM-101, intended for the treatment of chronic immuno-inflammatory digestive diseases and immuno-oncology, has demonstrated a significant therapeutic margin and absence of toxicity in its phase I healthy volunteers with the protocol for the Phase 1b/2a oncology trial submitted at the end of March 2025 and accepted in September 2025.
2. OPM-201, initially licensed to Servier and intended for the treatment of Parkinson's disease, completed its phase I trial in healthy volunteers at the end of 2024, and was reintegrated into OPM's portfolio. In February 2026, OPM received funding from the Michael J. Fox Foundation for this program to prepare for the launch of a Phase 1b trial in 2027 involving people with early-stage Parkinson’s disease, with a focus on those carrying an LRRK2 gene mutation

Both molecules come from the Nanocyclix^® technology platform, which enables the design and selection of small, highly effective and selective macrocyclic kinase inhibitors. We now have 12,000 molecules in our library and will be using AI to accelerate the discovery of drug candidates while reducing the cost of this phase.

OPM's other two technology platforms are:

• OncoSNIPER, for the selection of therapeutic targets using artificial intelligence,
• PROMETHE^® for the design and selection of radiolabeled biological molecules for systemic radiotherapy.

OPM, co-founded by Philippe Genne, Jan Hoflack and Karine Lignel, is based in Dijon, at the heart of the university and hospital cluster, and employs 14 people.

More info at: oncodesign.com

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OPM Karine Lignel Deputy General Manager Tel: +33 (0)310 451 820 investisseurs@oncodesign.com

NewCap Investor Relations Mathilde Bohin / Alban Dufumier Tel: +33 (0)1 44 71 94 95 oncodesign@newcap.eu

NewCap Media Relations Arthur Rouillé Tel: +33 (0)1 44 71 00 15 oncodesign@newcap.eu