Addex Therapeutics Limited (ADXN)

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Addex Provides Corporate Update and Financial Guidance
July 21 2022 - 01:00AM
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Ad Hoc Announcement Pursuant to Art. 53 LR

Geneva, Switzerland, July 21, 2022 - Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today provided a corporate update, including a review of its pipeline and financial guidance.

“We completed the half year with CHF8.8 million of cash and expect to be able to finance our operations until the end of 2022. During this period, we will focus on concluding partnering agreements on selected pipeline assets to secure the financial resources to advance their development and strengthen our balance sheet,” said Tim Dyer, CEO of Addex. “In parallel, we look forward to the read out of data from the ADX71149 Phase 2 epilepsy study, conducted by our partner, Janssen, which is scheduled for the end of the year as well as delivering drug candidates, ready for IND enabling studies, under our strategic partnership with Indivior.”

Corporate Update

Cash and cash equivalents at June 30, 2022 of CHF8.8 million
Dipraglurant, mGlu5 NAM: Following termination of development in a pivotal Phase 2B/3 levodopa-induced dyskinesia associated with Parkinson's disease (PD-LID) study due to slow recruitment of patients and the consequential excessive costs of continuing development (announced June 17, 2022), we have initiated discussions with potential strategic partners to reinitiate Phase 2 development of dipraglurant in PD-LID or an alternative indication, including pain, substance use disorders (SUD), neurodevelopmental disorders and stroke.
ADX71149, mGlu2 PAM, licensed to Janssen Pharmaceuticals Inc., a Johnson and Johnson company, is in a Phase 2 study in epilepsy patients and on track to report data in Q4 2022. Under our agreement with Janssen, we are eligible to receive up to EUR 109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales.
GABA B PAM Strategic Partnership with Indivior: Currently in clinical candidate selection phase with IND enabling studies expected to be initiated by Indivior in the first quarter of 2023 for SUD. Under the agreement with Indivior, in addition to research funding, we are eligible to receive $330 million in development, regulatory and sales milestones as well as the right to select drug candidates for development in certain exclusive indications outside of SUD. We plan to develop our selected drug candidates in pain and CMT1A.
mGlu7 NAM for the treatment of stress related disorders, including PTSD: A highly innovative first in class program, with a lead drug candidate ready to start IND enabling studies.
mGlu2 NAM for the treatment of mild neurocognitive disorders and depression: A well validated target with multiple differentiated drug candidates entering clinical candidate selection phase.
M4 PAM for the treatment of schizophrenia and other psychotic disorders: A well validated target for which Addex has identified multiple novel series of structurally differentiated selective M4 PAMs. These novel series of compounds have rapidly progressed into lead optimization and are anticipated to enter clinical candidate selection phase in 2023.

About Addex Therapeutics:
Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications. Addex's second clinical p