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Addex spin-out completes NTX-253 Phase 1 studies

The Phase 1 study included healthy volunteers and stable schizophrenia patients and provided safety and pharmacokinetic data.

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Form Type
6-K

Rhea-AI Filing Summary

Addex Therapeutics Ltd. announced that its spin-out Neurosterix completed Phase 1 clinical studies of NTX-253 and plans to advance the M4 positive allosteric modulator into Phase 2 development for schizophrenia. Addex holds a 20% equity interest in Neurosterix.

The studies included healthy volunteers and stable schizophrenia patients and provided safety and pharmacokinetic data. The multi-part study included single and multiple ascending dose components, food-effect testing and cerebrospinal fluid assessments.

Filing Explained

The Form 6-K makes its October 8 press release part of Addex’s Form F-3 and two Form S-8 registration statements from the filing date, unless later filings supersede it.

Phase 1 clinical studies Completed NTX-253 studies
Planned next development phase Phase 2 Neurosterix plans to advance NTX-253
Addex equity interest 20% Neurosterix
Series A financing $65 million Neurosterix financing in April 2024
positive allosteric modulator (PAM) technical
"NTX-253 is a positive allosteric modulator (PAM) of the muscarinic M4 receptor"
A positive allosteric modulator (PAM) is a drug-like molecule that increases the effect of a body’s own signaling chemical on a specific receptor without directly turning the receptor on itself — imagine turning up the volume on a radio only when a station is already playing. For investors, PAMs matter because they can produce more precise therapeutic effects with potentially fewer side effects than drugs that force receptors to act, making them attractive, differentiated assets in a biotech portfolio with important implications for clinical success and commercial value.
single ascending dose (SAD) medical
"single ascending dose (SAD) and multiple ascending dose (MAD) components"
A single ascending dose (SAD) is a type of test where a new medicine is given to a small group of people in increasing amounts to see how the body responds. This process helps determine the safest and most effective dose for future use. For investors, understanding SAD studies can provide insight into a drug's development progress and potential approval prospects.
multiple ascending dose (MAD) medical
"single ascending dose (SAD) and multiple ascending dose (MAD) components"
Multiple ascending dose (MAD) is a research process used to test how a new medicine affects the body when given in increasing amounts over several doses. It helps researchers find the safest and most effective dose before the drug is widely used. For investors, understanding MAD studies is important because successful results can signal progress toward new treatments and potential future profits.
pharmacokinetic data medical
"important safety and pharmacokinetic data"
Measurements that show how a drug moves through the body—how quickly it is absorbed, how long it stays in the bloodstream, how it is broken down, and how it is eliminated. Investors care because these numbers help predict a medicine’s dosing, safety and effectiveness, like a map showing how fast and far a delivery truck travels, which affects whether a drug can reach the market and how it will be used.
cerebrospinal fluid (CSF) medical
"food-effect and cerebrospinal fluid (CSF) assessments"
Cerebrospinal fluid (CSF) is a clear liquid that surrounds and cushions the brain and spinal cord, providing protection and helping to remove waste. Although it is a medical term, in a financial context, understanding how resources and support flow within a system can be similar to how CSF circulates and maintains the health of the nervous system. Recognizing such fundamental processes can offer insights into the stability and resilience of broader systems, including financial markets.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ADXN’s NTX-253 Phase 1 study include?

The study included healthy volunteers and stable schizophrenia patients. It had single ascending dose and multiple ascending dose components, and incorporated food-effect and cerebrospinal fluid assessments.

What is Addex’s ownership stake in Neurosterix?

Addex holds a 20% equity interest in Neurosterix, its spin-out company.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of October 2026

Commission File Number: 001-39179

Addex Therapeutics Ltd
(Translation of registrant's name into English)

Chemin des Mines 9,
CH-1202 Geneva,
Switzerland

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]


 

On October 8, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

(c) Exhibit 99.1. Press release dated October 8, 2026

INCORPORATION BY REFERENCE

Exhibit 99.1 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration No. 333-291644) of Addex Therapeutics Ltd and the registration statement on Form S-8 (Registration No. 333-255124 and No. 333-272515) of Addex Therapeutics Ltd (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. 

RISK FACTORS 

Our business faces significant risks. You should carefully consider all of the information set forth in this Report on Form 6-K and in our other filings with the United States Securities and Exchange Commission, or the SEC, including the risk factors related to our business set forth in our Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission on May 15, 2026. Our business, financial condition, results of operations and growth prospects could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described in our Annual Report and our other SEC filings.

 


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

      Addex Therapeutics Ltd    
  (Registrant)
   
  
Date: October 8, 2026     /s/ Tim Dyer    
  Tim Dyer
  Chief Executive Officer
  


EXHIBIT INDEX 

Exhibit Number Description
   
99.1 Press release dated October 8, 2026

EXHIBIT 99.1

Addex Spin-Out Neurosterix Completes Phase 1 Clinical Studies of NTX-253 for Schizophrenia

Ad Hoc Announcement Pursuant to Art. 53 LR 

Geneva, Switzerland, October 8, 2026 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced that its spin-out company, Neurosterix, in which Addex holds a 20% equity interest, has completed its Phase 1 clinical studies evaluating NTX-253 and plans to advance NTX-253 into Phase 2 clinical development. NTX-253 is a positive allosteric modulator (PAM) of the muscarinic M4 receptor being developed for the treatment of schizophrenia.

“Completing Phase 1 and the decision by Neurosterix to progress NTX-253 into Phase 2 studies in schizophrenia patients is a significant achievement,” said Tim Dyer, CEO of Addex. “The well-designed study combining healthy volunteers and schizophrenia patients within a single study has provided important safety and pharmacokinetic data.”

The clinical study includes a multi-part, ascending-dose design intended to efficiently characterize NTX-253’s clinical profile and support subsequent patient-focused development. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) components, incorporating key translational elements such as food-effect and cerebrospinal fluid (CSF) assessments. The studies included both healthy volunteers and stable schizophrenia patients, and has provided important safety and pharmacokinetic data.

Neurosterix was spun-out of Addex in April 2024, raising $65 million in a Series A financing led by funds affiliated with Perceptive Advisors. Addex retains a 20% equity interest in Neurosterix.

About NTX-253 and M4 PAMs

The M4 muscarinic receptor is a validated target for treating schizophrenia and related disorders through indirect modulation of dopamine signaling. NTX-253 is a potent, selective, oral PAM of M4 that fine-tunes muscarinic signaling with the potential to reduce psychosis symptoms while avoiding the movement disorders and metabolic complications associated with traditional dopamine antagonists. Preclinical studies demonstrate robust antipsychotic-like activity and a favorable safety profile.

About Addex Therapeutics

Addex Therapeutics s a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex's has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND enabling studies. Addex is also advancing an differentiated GABAB PAM compound for chronic cough. Addex holds a 20% equity interest in a private spin out company, Neurosterix US Holdings LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, psychosis and mood-related disorders and mGlu7 NAM for mood disorders. In addition, Addex has also invested in Stalicla, a private Swiss company pioneering a precision medicine approach for neurodevelopmental and neuropsychiatric disorders.

Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange. For more information, visit www.addextherapeutics.com.

Contacts:

Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55
PR@addextherapeutics.com
Mike Sinclair
Partner, Halsin Partners
+44 (0)7968 022075
msinclair@halsin.com

Addex Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Addex Therapeutics' Annual Report on Form 20-F, prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements. 

Filing Exhibits & Attachments

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