Addex Therapeutics Ltd.

Addex Therapeutics Ltd is a clinical-stage pharmaceutical company focused on developing a portfolio of novel orally available small molecule drug candidates for diseases with unmet needs, including post-stroke sensorimotor recovery, traumatic brain injury (TBI) recovery, substance use disorders (SUD), and chronic cough ¹. The company also holds a 20% equity interest in Neurosterix US Holdings LLC, a private company developing preclinical stage drug candidates for schizophrenia and mood disorders ². Addex Therapeutics generates revenue primarily from license fees, milestone payments from collaborations, royalties, and payments from sponsored research and development activities, as well as grants from governmental and non-governmental organizations ³. The company has historically funded its operations mainly through equity offerings, having raised an aggregate of CHF 356.6 million ⁴ in gross proceeds from equity sales since inception through December 31, 2025.

The core business model revolves around the discovery and development of allosteric modulators of G-protein coupled receptors (GPCRs). Allosteric modulators interact with binding sites distinct from the endogenous activator, enhancing or inhibiting natural physiological activity only in the presence of the endogenous activator, which is believed to offer advantages such as novel drug classes, superior receptor sub-type selectivity, ability to target more GPCRs, re-addressing validated targets, improved safety, and potential for combination therapies ⁵. The company's strategy includes continuing to evaluate dipraglurant for post-stroke/TBI recovery, evaluating new indications for ADX71149, advancing its GABAB PAM program, and pursuing collaborative arrangements with pharmaceutical companies ⁶.

The company's development portfolio includes several key programs. Dipraglurant, a metabotropic glutamate receptor subtype 5 negative allosteric modulator (mGlu5 NAM), is currently under evaluation for future development in post-stroke/TBI recovery ⁷. On April 30, 2025, Addex announced an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for brain injury recovery, which also includes a research collaboration for evaluating dipraglurant ⁸. ADX71149, a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator (mGlu2 PAM), was returned to Addex by its partner Janssen on April 17, 2025, after a Phase 2 study did not achieve statistical significance for its primary endpoint ⁹. Addex is currently evaluating the future development of ADX71149 ¹⁰. The GABAB PAM program for substance use disorders is licensed to Indivior PLC, which selected a compound for future development on August 27, 2024, and successfully completed IND enabling studies by May 12, 2025 ¹¹. Addex has also exercised its right to select a compound from this program for its own independent GABAB PAM program for chronic cough, which has demonstrated robust anti-tussive activity in preclinical models ¹².

For the fiscal year ended December 31, 2025, Addex Therapeutics reported total revenue of CHF 29,972 ¹³, a decrease from CHF 404,102 ¹⁴ in 2024. Other income increased to CHF 142,888 ¹⁵ in 2025 from CHF 5,940 ¹⁶ in 2024. Research and development costs from continuing operations were CHF 671,651 ¹⁷ in 2025, down from CHF 854,305 ¹⁸ in 2024. General and administrative costs remained stable at CHF 2,315,807 ¹⁹ in 2025 compared to CHF 2,310,970 ²⁰ in 2024. The company reported an operating loss from continuing operations of CHF 2,814,598 ²¹ in 2025, compared to an operating loss of CHF 2,755,233 ²² in 2024. The net loss from continuing operations was CHF 6,842,588 ²³ in 2025, compared to a net loss of CHF 4,909,342 ²⁴ in 2024. The share of net loss of investments accounted for using the equity method, primarily from Neurosterix Group, was CHF 4,012,443 ²⁵ in 2025, an increase from CHF 2,177,157 ²⁶ in 2024. The net loss for the period was CHF 6,728,246 ²⁷ in 2025, a significant change from a net profit of CHF 7,055,787 ²⁸ in 2024. Basic and diluted loss per share from continuing operations was CHF (0.06) ²⁹ in 2025, compared to CHF (0.05) ³⁰ in 2024. Cash and cash equivalents stood at CHF 1,638,612 ³¹ as of December 31, 2025, down from CHF 3,341,738 ³² in 2024. Total current liabilities were CHF 1,198,964 ³³ and total non-current liabilities were CHF 398,616 ³⁴ as of December 31, 2025. The company had an accumulated deficit of CHF 360,090,701 ³⁵ as of December 31, 2025.

Year-over-year comparisons show a substantial decrease in revenue from collaborative research funding, falling from CHF 404,102 ³⁶ in 2024 to CHF 29,972 ³⁷ in 2025, primarily due to the termination of the research agreement with Indivior on June 30, 2024 ³⁸. Other income increased by CHF 0.1 million ³⁹ in 2025, mainly due to the fair value of the extended service agreement with Neurosterix Group ⁴⁰. Research and development expenses from continuing activities decreased by CHF 0.2 million ⁴¹ in 2025, largely due to lower GABAB PAM outsourced R&D expenses following the completion of the Indivior research agreement ⁴². General and administrative costs remained stable at CHF 2.3 million ⁴³ in both 2024 and 2025. The finance result shifted from a net gain of CHF 23,048 ⁴⁴ in 2024 to a net expense of CHF (15,547) ⁴⁵ in 2025, driven by foreign exchange losses ⁴⁶. The share of net loss from investments accounted for using the equity method increased from CHF 2,177,157 ⁴⁷ in 2024 to CHF 4,012,443 ⁴⁸ in 2025, reflecting 20% of Neurosterix Group's net loss ⁴⁹.

Significant operational developments during the period include the termination of the ADX71149 development by Janssen on April 17, 2025, and the return of the program and intellectual property to Addex ⁵⁰. On April 30, 2025, Addex entered into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering mGlu5 inhibitors for brain injury recovery, including a research collaboration for dipraglurant ⁵¹. Indivior successfully completed IND enabling studies for their selected GABAB PAM compound for substance use disorders by May 12, 2025 ⁵². In June 2025, Addex invested CHF 795,029 ⁵³ in Stalicla SA, receiving preferred shares and derivative financial instruments ⁵⁴.

Addex Therapeutics expects to continue incurring significant expenses and operating losses in the medium to long term, with anticipated increases in expenses as the company continues development of its GABAB PAM chronic cough drug candidate, initiates further clinical trials, and seeks marketing approval for its drug candidates ⁵⁵. The company believes its existing cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements through mid-June 2026 ⁵⁶. Future viability is dependent on the ability to monetize its intellectual property portfolio or financial assets and raise additional capital through public or private financings or collaboration agreements ⁵⁷.

A major growth area for Addex is the continued evaluation of dipraglurant for post-stroke/TBI recovery. The company has entered into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for brain injury recovery ⁵⁸. This agreement includes a research collaboration where the Sinntaxis team will complete the evaluation of dipraglurant for brain injury recovery ⁵⁹. Addex is conducting further in vivo testing in stroke models and, subject to securing funding or a development partner, plans to initiate a Phase 2a clinical study ⁶⁰. The company believes there is a large unmet need in this area and that this innovative approach presents a significant commercial opportunity ⁶¹.

Another growth vector is the advancement of the GABAB PAM program, particularly for chronic cough. Under the license agreement with Indivior, Addex has exercised its right to select a compound for its own independent GABAB PAM program for chronic cough ⁶². This selected compound has demonstrated robust anti-tussive activity in multiple preclinical models compared to reference drugs ⁶³. Subject to securing funding or a development partner, Addex plans to initiate IND enabling studies for this independent chronic cough program ⁶⁴. The company also plans to evaluate new indications for ADX71149, which has drug product ready, and subject to securing funding or collaborative arrangements, plans to initiate clinical studies ⁶⁵.

Operationally, the company's research and development expenses are lower following the Neurosterix Transaction executed on April 2, 2024 ⁶⁶. However, in the medium and long term, expenses may increase as the company continues development of the GABAB PAM chronic cough drug candidate, initiates further clinical trials, and seeks marketing approval ⁶⁷. The company has no ongoing self-funded clinical studies ⁶⁸. As of January 1, 2025, the service agreement with Neurosterix Group, which provided access to certain employees and infrastructure at zero cost, was not formally renewed, though Neurosterix has continued to provide access to research and development staff at zero cost ⁶⁹. Since February 28, 2026, Addex assumed responsibility for the rent of its administrative offices ⁷⁰.

Planned capital allocation includes continued investment in the portfolio of preclinical and clinical stage programs, hiring additional research and development and general and administrative personnel, maintaining and expanding the intellectual property portfolio, and identifying and in-licensing or acquiring additional drug candidates ⁷¹. The company will also incur additional costs associated with operating as a public company in the United States ⁷². Addex has an "at the market offering" (ATM) program with H.C. Wainwright & Co., LLC, under which it started selling ADSs in January 2026, raising gross proceeds of USD 0.2 million ⁷³ up until the publication of the Annual Report. The sale agency agreement with Kepler Cheuvreux has been extended to December 31, 2026 ⁷⁴, and has generated gross proceeds of CHF 3.3 million ⁷⁵ since its inception.

Addex Therapeutics faces significant risks, including the need for substantial additional capital to fund continued development activities, with current cash and cash equivalents only sufficient through mid-June 2026 ⁷⁶. The company is a development-stage entity with no products on the market, and there is no guarantee that drug candidates will be successfully tested, approved, or commercialized ⁷⁷. Dependence on partners like Indivior exposes Addex to risks, as partners have sole responsibility for funding and development, and their strategic focus may not align with Addex's best interests ⁷⁸. The termination of the ADX71149 development by Janssen highlights the risk of clinical trial failures ⁷⁹. The company relies on third-party CROs and manufacturers, which introduces risks related to performance, quality, and supply interruptions ⁸⁰. Regulatory approval processes are expensive, time-consuming, and uncertain, with potential for delays, suspensions, or terminations of clinical trials ⁸¹. The biopharmaceutical industry is highly competitive, with many competitors possessing greater resources and experience, potentially developing superior or earlier-to-market drugs ⁸². Failure to obtain, maintain, or enforce intellectual property rights, including patents and trade secrets, could adversely affect competitive advantage ⁸³. Lack of market acceptance, even for approved drugs, due to factors like efficacy, safety, cost-effectiveness, or third-party payor reimbursement, could prevent revenue generation ⁸⁴. Developing internal sales, marketing, and distribution capabilities or securing third-party arrangements is crucial for commercialization and carries significant risks ⁸⁵. The company is exposed to costly and damaging liability claims inherent in drug development, testing, and manufacturing, with no assurance of sufficient insurance coverage ⁸⁶. Compliance with extensive government regulations, including marketing authorization requirements and healthcare fraud and abuse laws, is complex and subject to change, potentially leading to penalties or restrictions ⁸⁷. Currency fluctuation risks are present, as approximately 32% ⁸⁸ of costs and 21% ⁸⁹ of revenue in 2025 were denominated in non-Swiss franc currencies, and future milestone payments from Indivior are in USD ⁹⁰. Cybersecurity breaches and failure to comply with data privacy regulations, such as the EU General Data Protection Regulation (GDPR) with potential fines up to €20 million or 4% of annual worldwide revenue ⁹¹, pose significant financial and reputational risks. The company was classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes for the taxable year ended December 31, 2025, which may have adverse consequences for U.S. holders ⁹².

Management's message to shareholders conveys a focus on advancing the existing pipeline and securing additional funding or partnerships to support future development. The company explicitly states that its current cash and cash equivalents are expected to fund operating expenses and capital expenditure requirements through mid-June 2026 ⁹³, indicating a near-term need for additional capital. Strategic priorities include continuing to evaluate dipraglurant for post-stroke/TBI recovery, evaluating new indications for ADX71149, and continuing to advance the GABAB PAM program, particularly for chronic cough, with plans to initiate IND enabling studies for the latter two programs subject to securing funding or development partners ⁹⁴. Management also emphasizes the ongoing pursuit of collaborative arrangements with pharmaceutical companies to advance development and commercialization of drug candidates ⁹⁵. The overall tone acknowledges the significant expenses and operating losses expected in the medium to long term as the company progresses its programs through clinical development and regulatory approval ⁹⁶.