On March 10, 2022 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2021 and provided a corporate update (Press release, Addex Therapeutics, MAR 10, 2022, View Source [SID1234609846]).
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"These are exciting times for Addex! We have three ongoing clinical trials with data starting to report as early as Q2 this year and multiple preclinical programs advancing rapidly through clinical candidate selection phase with strong novel IP across all programs," said Tim Dyer, CEO of Addex. "The extension of our collaboration with Indivior and the additional $4M of funding as well as the $10M financing from Armistice capital contributed to our completing the year with a strong cash position of $22.5M."
2021 Operating Highlights:
Phase 2 clinical trial with dipraglurant in blepharospasm patients on track to report data in Q2 2022
Phase 2b/3 dipraglurant study in dyskinesia associated with Parkinson’s disease expected to report data in H1 2023
Janssen Pharmaceuticals led Phase 2a clinical study of ADX71149 in epilepsy patients on track to report data in Q3 2022
Extended our strategic collaboration with Indivior to advance GABAB PAM until mid-2022 with $4M additional funding
Continued to advance GABAB PAM drug candidates through clinical candidate selection phase
Entered a research collaboration with the Charcot–Marie–Tooth Association (CMTA) to evaluate selected drug candidates in preclinical models of CMT1A
Advanced Eurostars / Innosuisse funded mGlu7 NAM program for post-traumatic stress disorder
Continued to advance preclinical programs to next value inflection points
Select Upcoming Milestones:
Q2 2022 – Phase 2a data: dipraglurant for blepharospasm
Q3 2022 – Phase 2a data: ADX71149 for epilepsy
H1 2023 – Phase 2b/3 data: dipraglurant for dyskinesia associated with Parkinson’s disease
Key 2021 Financial Data
Financial Summary:
Income decreased by CHF 0.7 million to CHF 3.2 million in 2021 compared to CHF 3.9 million in 2020, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.
R&D costs increased by CHF 2.4 million to CHF 12.8 million in 2021 compared to CHF 10.4 million in 2020, mainly due to increased outsourced R&D expenses for CHF 2.0 million of which CHF 0.6 million relates to our dipraglurant PD-LID program and CHF 0.6 million for our dipraglurant blepharospasm 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 remained stable around CHF 5.8 million in 2021 and 2020.
The net loss was CHF 15.4 million in 2021 compared to CHF 12.9 million in 2020 primarily due to increased R&D expenses. Basic and diluted loss per share decreased to CHF 0.45 for the year ended December 31, 2021, compared to CHF 0.48 for the year ended December 31, 2020.
Cash and cash equivalents increased to CHF 20.5 million at December 31, 2021, compared to CHF 18.7 million at December 31, 2020. This increase of CHF 1.8 million is mainly due to the two offerings executed on January 8, 2021 and December 16, 2021 for total net proceeds of CHF 16 million partially offset by our net loss of CHF 15.4 million. During the same period, non-cash items mainly relating to the value of share-based services amounted to CHF 1.4 million have been partially off-set by the net effect of the increased net working capital of CHF 0.6 million.
2021 Consolidated Financial Statements:
The full-year 2021 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 10, 2022, 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.
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