On April 8, 2020 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported its full-year audited results for the year ended December 31, 2019 and provided a corporate update (Press release, Addex Therapeutics, APR 8, 2020, View Source [SID1234561372]).
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"We made significant progress in 2019 in advancing our pipeline of innovative in-house discovered allosteric modulators, including our priority dipraglurant levodopa-induced dyskinesia program, which is ready to start dosing patients in a pivotal registration clinical trial as soon as the Covid-19 crisis is over," said Tim Dyer, CEO of Addex. "We also achieved important milestones in our GABAB PAM collaboration with Indivior and secured funding from Eurostars/Innosuisse to advance our mGlu7NAM program for PTSD as well as completing the listing of American Depositary Shares (ADSs) on the Nasdaq Stock Market."
2019 Operating Highlights:
Dipraglurant pivotal phase 2b/3 clinical trial expected to dose first patient in H2 2020 and readout topline results in Q2 2022
Indivior funded GABAB PAM research program on track to deliver drug candidates by end of 2020
Addex led consortium awarded Eurostars grant of €4.85 million to fund discovery of mGlu7 NAM drug candidates for post-traumatic stress disorder
Completed 2019 with a strong liquidity position of CHF31.5 million of cash and cash equivalents
Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020
Key 2019 Financial Data:
Financial Summary:
Revenue decreased by CHF 3.2 million to CHF 2.8 million in 2019 compared to CHF 6.0 million in 2018, primarily due to the absence of the USD 5.0 million (CHF4.8 million) upfront payment received from Indivior in January 2018 but partially offset by the increase in collaborative research funding from Indivior PLC.
Other income decreased by CHF 0.6 million to CHF 0.1 million in 2019 compared to CHF 0.7 million in 2018, primarily due to the absence of MJFF research grants recognized in 2018. In 2019, research grants relate to amounts recognized under our Eurostars/Innosuisse grant.
Research and development expenses increased by CHF7.5 million to CHF 12.4 million in 2019 compared to CHF 4.9 million in 2018, mainly due to an increase in outsourced development costs related to our dipraglurant PD-LID program and to a lesser extent our GABAB PAM program. 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 1.8 million to CHF 5.0 million in 2019, compared to CHF 3.2 million in 2018, mainly due to the increase in headcount and costs related to preparing the listing of ADSs representing our shares on the Nasdaq Stock Market.
The net loss for 2019 was CHF 14.8 million compared to CHF 1.6 million for 2018. Basic and diluted loss per share increased to CHF 0.56 for 2019, compared to CHF 0.07 for 2018.
Cash and cash equivalents amounted to CHF 31.5 million at December 31, 2019 compared to CHF 41.7 million at December 31, 2018. This decrease of CHF 10.2 million is mainly due to the net loss of CHF 14.8 million, adjusted for changes in net working capital of CHF 2.9 million and non-cash items of CHF 2.1 million. Non-cash items relate mainly to the value of share-based services. Changes in working capital relate mainly to an increases of CHF1.1 million and CHF0.9 million in payables and accruals, respectively that are primarily related to our dipraglurant PD-LID program and professional service fees related to our recent listing of ADSs on the Nasdaq stock market, as well as CHF 0.7 million of increased contract liabilities related to our funded research contract with Indivior.
2019 Annual Report:
The 2019 annual report can be found on the investor relations page of our website
Conference Call Details:
A conference call will be held today, April 8, 2020, at 16:00 CEST (15:00 BST / 10:00 ET) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer, Jean-Philippe Rocher, Head of Discovery Chemistry and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.
Link to live event online:
1: In the 10 minutes prior to the call start time, sign in online by following this link Webex Link.
2: Password: Welcome