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 March 2021

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 [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):


 

On March 11, 2021, 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 March 11, 2021

 


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: March 11, 2021       /s/ Tim Dyer    
    Tim Dyer
    Chief Executive Officer
   

EXHIBIT INDEX 

Exhibit Number   Description
     
99.1   Press release dated March 11, 2021

EXHIBIT 99.1

Addex Reports Full Year 2020 Financial Results and Provides Corporate Update

Geneva, Switzerland, March 11, 2021 – Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today reported financial results for the full-year ended December 31, 2020 and provided a corporate update.

“We ended 2020 in a strong financial position, which was supplemented by our successful $11.5 million fundraising at the beginning of 2021,” said Tim Dyer, CEO of Addex. “Throughout 2020, we advanced preparations for the start of clinical studies targeting large underserved market opportunities. Clinical studies starting in the first half of 2021 include two internal programs, dipraglurant in Parkinson’s disease LID and blepharospasm. Additionally, our partner, Janssen is expected to start clinical studies with ADX71149 for epilepsy in the second quarter. Our collaboration with Indivior continues to move forward at a rapid pace and expect to deliver compounds for IND enabling studies by the end of this year.”

Select Upcoming Milestones:

2020 Operating Highlights:

Key 2020 Financial Data

CHF’ thousands 2020  2019 Change
Income 3,879 2,834 1,045
R&D expenses (10,373) (12,454) 2,081
G&A expenses (5,749) (4,984) (765)
Total operating loss (12,243) (14,604) 2,361
Finance result, net (616) (176) (440)
Net loss for the period (12,859) (14,780) 1,921
Basic and diluted net loss per share (0.48) (0.56) 0.08
Net decrease in cash and cash equivalents (12,842) (10,133) (2,709)
Cash and cash equivalents 18,695 31,537 (12,842)
Shareholders’ equity 14,610 25,524 (10,914)

Financial Summary:
Income increased by CHF 1.0 million to CHF 3.9 million in 2020 compared to CHF 2.8 million in 2019, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D expenses decreased by CHF 2.1 million to CHF 10.4 million in 2020 compared to CHF 12.4 million in 2019, primarily due to delays in starting certain clinical development activities due to the global coronavirus pandemic. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D. 

G&A expenses increased by CHF 0.7 million to CHF 5.7 million in 2020 compared to CHF 5.0 million in 2019 mainly due to the increase of CHF 1.3 million relating to increased directors and officer’s liability insurance premiums partially offset by a decrease of CHF 0.5 million in audit and legal fees.

The net loss for 2020 was CHF 12.9 million compared to CHF 14.8 million for 2019 primarily due to the decrease in R&D costs. Basic and diluted loss per share decreased to CHF 0.48 for 2020, compared to CHF 0.56 for 2019.

Cash and cash equivalents amounted to CHF 18.7 million at December 31, 2020 compared to CHF 31.5 million at December 31, 2019. This decrease of CHF 12.8 million is mainly due to the net loss.

2020 Condensed Consolidated Interim Financial Statements:
The full-year 2020 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, March 11, 2021, at 16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:
1: In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.   
Dial-In Numbers:

2: Provide the Operator with the Participation Pin Code: 92320595#

Link to live event online:
1: In the 10 minutes prior to the call start time, sign in online by following this Webex link.
2: Password: Welcome

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 poised to start a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) in H1 2021. Addex is also investigating dipraglurant's therapeutic use in blepharospasm (a type of dystonia), for which a clinical trial is expected to be initiated in H1 2021. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc, is scheduled to enter a phase 2a proof of concept clinical study for the treatment of epilepsy in Q2 2021. Addex’s GABAB PAM program has been licensed to Indivior PLC who are focused on development for the treatment of addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. Addex is listed on the SIX Swiss Exchange and the NASDAQ Capital Market and trades under the ticker symbol "ADXN".

Press Contacts:

Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55          
PR@addextherapeutics.com
Mike Sinclair
Partner, Halsin Partners
+44 (0)20 7318 2955
msinclair@halsin.com
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com

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 in respect of the anticipated initiation of clinical trials. 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 for the year ended December 31, 2019, as filed with the SEC on April 27, 2020, the prospectus related to the global offering 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.