IRLAB comments on statements in Ipsen’s 2022 Universal Registration Document and the further development of mesdopetam

May 3, 2023

Gothenburg, Sweden, May 3, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company that discovers and develops new treatments for Parkinson’s disease, announced today that IRLAB has been made aware that Ipsen’s 2022 Universal Registration Document, published on April 6, 2023, contains incorrect information that the development and commercialization rights for mesdopetam have been transferred back to IRLAB. This is not correct. Collaborative discussions regarding mesdopetam’s further development path are ongoing.

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Gothenburg, Sweden, May 3, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company that discovers and develops new treatments for Parkinson's disease, announced today that IRLAB has been made aware that Ipsen’s 2022 Universal Registration Document, published on April 6, 2023, contains incorrect information that the development and commercialization rights for mesdopetam have been transferred back to IRLAB. This is not correct. Collaborative discussions regarding mesdopetam’s further development path are ongoing.

In the document, it was stated that the development and commercialization rights for mesdopetam have been transferred back to IRLAB. IRLAB has not received any termination of the license agreement, nor any transfer of the mesdopetam project. IRLAB has been informed that Ipsen will rectify.

Following a contact from Ipsen on May 1, 2023, a discussion was initiated with IRLAB to mutually agree on the best way forward to secure that the mesdopetam program gets the best possible prospects to reach registration and to ensure that mesdopetam can be made available to the benefit of people living with Parkinson’s disease.

IRLAB and IRLAB’s regulatory and commercial advisors have a strong belief in the clinical and commercial potential of mesdopetam. After the completed Phase I and Phase II study programs, combined with Ipsens contribution to the Phase III preparations, including completion of the additional regulatory Phase I pharmacokinetic studies, manufacturing of drug substance and drug product, IRLAB’s assessment is that mesdopetam will be ready for Phase III.

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