• CHF10.4M ($10.4M) of cash and cash equivalents at September 30, 2022
• Janssen led ADX71149 Phase 2 study in epilepsy on track to complete part 1 in Q1 2023
  
  

Ad Hoc Announcement Pursuant to Art. 53 LR

Geneva, Switzerland, November 11, 2022 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today reported its Q3 financial results for the period ended September 30, 2022 and provided a corporate update.

“The extension of our strategic collaboration with Indivior and the recent financing from Armistice Capital provides us with the runway to execute on our strategic priorities, including pursuing additional collaborative arrangements across our portfolio,” said Tim Dyer, CEO of Addex. “In addition, we are looking forward to the completion of part 1 of the ADX71149 epilepsy Phase 2 study in Q1 2023 and continue to evaluate the path forward for dipraglurant in a number of interesting disease areas in parallel to discussions with potential strategic partners.”

Q3 2022 Operating Highlights:

• ADX71149 epilepsy Phase 2 study on track to complete part 1 in Q1 2023
• GABAB PAM strategic partnership with Indivior for substance use disorders extended – multiple drug candidates in late stages of clinical candidate selection phase
• GABAB PAM CMT1A, chronic cough and pain program profiling multiple drug candidates
• mGlu7 NAM stress related disorders program delivered an IND enabling study ready drug candidate
• mGlu2 NAM mild neurocognitive disorders program enters clinical candidate selection phase
• M4 PAM schizophrenia program progressing well through lead optimization
• CHF 4.6M equity financing completed in July 2022

Key Financial Data for the three-months and nine-months ended September 30, 2022:

Financial Summary:
Income is primarily from our funded research collaboration with Indivior. During the nine-months ended September 30, 2022, income decreased by CHF 1.9 million to CHF 0.8 million compared to CHF 2.7 million in the nine-months ended September 30, 2021. During the third quarter of 2022, income decreased by CHF 0.3 million to CHF 0.4 million compared to CHF 0.7 million in the third quarter of 2021. The decrease in income from Indivior is a reflection of the positive progression of the collaboration into late stages of clinical candidate selection and the transfer of R&D activities to Indivior. The collaboration agreement with Indivior has been extended until March 31, 2023.

R&D expenses evolution is primarily driven by our dipraglurant clinical development activities. During the nine-months ended September 30, 2022, R&D expenses increased by CHF 2.9 million to CHF 12.3 million compared to CHF 9.3 million in the nine-months ended September 30, 2021. During the third quarter of 2022, R&D expenses decreased by CHF 0.1 million to CHF 2.8 million compared to CHF 2.9 million in the third quarter of 2021.

G&A expenses increased by CHF 1.0 million to CHF 5.6 million in the nine-months ended September 30, 2022 compared to CHF 4.6 million in the nine-months ended September 30, 2021, and by CHF 0.3 million to CHF 1.8 million during the third quarter of 2022 compared to CHF 1.5 million in the third quarter of 2021, primarily due to increased share-based compensation cost.
  

Net loss evolution is primarily driven by our R&D expenses and income. During the nine-months ended September 30, 2022, net loss increased by CHF 6.2 million to CHF 17.1 million compared to CHF 10.9 million in the nine-months ended September 30, 2021, and by CHF 0.5 million to CHF 4.1 million in the third quarter of 2022 compared to CHF 3.6 million in the third quarter of 2021.

Basic and diluted loss per share increased to CHF 0.42 for the nine-months ended September 30, 2022, compared to CHF 0.32 for the nine-months ended September 30, 2021. For the third quarter of 2022, the basic and diluted loss per share decreased to CHF 0.09 compared to CHF 0.11 for the third quarter of 2021.

Cash and cash equivalents amounted to CHF 10.4 million as of September 30, 2022 compared to CHF 15.5 million as of September 30, 2021. The decrease of CHF 5.1 million is primarily due to the cash used in operating activities partially offset by the proceeds from equity offerings executed on December 16, 2021 and July 22, 2022 and to a lesser extent research funding from Indivior.

2022 Q3 Condensed Consolidated Interim Financial Statements:
The Q3 2022 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, November 11, 2022, at 16:00 CET (15:00 GMT / 11:00 EDT / 08:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer, Mikhail Kalinichev, Head of Translational Science and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:

1. Participants are required to register in advance of the conference using the link provided below. Upon registering, each participant will be provided with Participant Dial-in numbers, and a unique Personal PIN.
   
   
2. In the 10 minutes prior to the call start time, participants will need to use the conference access information provided in the e-mail received at the point of registering. Participants may also use the call me feature instead of dialing the nearest dial in number.
   
   

Online Registration: https://register.vevent.com/register/BI1d767881684d425182f51e33b96cffde

Webcast URL:
https://edge.media-server.com/mmc/p/2d395mr5

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, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept clinical trial for the treatment of epilepsy. Addex's second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAMs for CMT1A, chronic cough and several types of pain, mGlu7 NAM for stress related disorders, mGlu2 NAM for mild neurocognitive disorders and depression, M4 PAM for schizophrenia and other forms of psychosis, as well as mGlu4 PAM and mGlu3 PAM. 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.

Press Contacts:

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 the ability to discover molecules as part of the Indivior collaboration, the progress of clinical trials and preclinical studies, including the timing of data read-outs from the ADX71149 epilepsy study, and our intended strategic direction. 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, such as receipt of ongoing research payments and timing of the collaboration conclusion, 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 for the year ended December 31, 2021, as filed with the SEC on March 10, 2022, the prospectus supplement and accompanying 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.