On March 30, 2023 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, 2022, and provided a corporate update (Press release, Addex Therapeutics, MAR 30, 2023, View Source [SID1234629572]).
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"Our partner, Janssen made excellent progress in advancing the ADX71149 phase 2 clinical study in epilepsy patients and we look forward to the recommendation from the independent interim review committee, established to review the data from part 1," said Tim Dyer CEO of Addex. "We continue to make solid progress across our preclinical portfolio. In parallel, we are continuing to focus on pursuing collaborative arrangements to secure the financial resources and specialist expertise to advance development and strengthen our balance sheet."
2022 Operating Highlights:
ADX71149 epilepsy Phase 2 study part 1 completed with Independent interim review committee recommendation expected early Q2 2023
Dipraglurant is Phase 2 ready – future development in PD-LID, post-stroke recovery and pain under evaluation
mGlu7 NAM for stress related disorders, including PTSD – drug candidate selected for IND enabling studies, with study preparation underway
GABAB PAM strategic partnership with Indivior for substance use disorders extended – multiple drug candidates in clinical candidate selection phase
GABAB PAM CMT1A, chronic cough and pain program profiling multiple drug candidates
Continued to progress with mGlu2 NAM mild neurocognitive disorders program
M4 PAM schizophrenia program progressing well through lead optimization
Partnering discussions across the portfolio progressing well
Completed the close-down of dipraglurant PD-LID development and implemented cost saving measures
Completed offering in July 2022 raising gross proceeds of $4.2 million
Key 2022 Financial Data
CHF’ thousands 2022 2021 Change
Income 1,445 3,153 (1,708)
R&D expenses (14,665) (12,840) (1,825)
G&A expenses (7,300) (5,819) (1,481)
Total operating loss (20,520) (15,506) (5,014)
Finance result, net (284) 154 (438)
Net loss for the period (20,804) (15,352) (5,452)
Basic and diluted net loss per share (0.46) (0.45) (0.01)
Net increase / (decrease) in cash and cash equivalents (13,528) 1,790 (15,318)
Cash and cash equivalents 6,957 20,485 (13,528)
Shareholders’ equity 4,913 16,931 (12,018)
Financial Summary:
Income is primarily from our funded research collaboration with Indivior. Income decreased by CHF 1.7 million to CHF 1.4 million in 2022 compared to CHF 3.2 million in 2021. The decrease 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.
R&D expenses increased by CHF 1.8 million to CHF 14.6 million in 2022 compared to CHF 12.8 million in 2021, mainly due to increased outsourced R&D expenses for CHF 1.0 million and increased share-based compensation costs for CHF 0.6 million.
G&A expenses increased by CHF 1.5 million to CHF 7.3 million in 2022 compared to CHF 5.8 million in 2021, primarily due to higher share-based compensation costs.
The net loss was CHF 20.8 million in 2022 compared to CHF 15.4 million in 2021. Net loss increased by CHF 5.5 million, primarily due to our increased expenses and decreased income. Basic and diluted loss per share increased to CHF 0.46 for the year ended December 31, 2022, compared to CHF 0.45 for the year ended December 31, 2021.
Cash and cash equivalents decreased to CHF 7.0 million at December 31, 2022, compared to CHF 20.5 million at December 31, 2021. This decrease of CHF 13.5 million is mainly due to our net loss of CHF 20.8 million adjusted for non-cash expense items such as share based compensation of CHF3.7 million and net proceeds of CHF 3.7 million from the offering executed on July 22, 2022.
2022 Consolidated Financial Statements:
The full-year 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, March 30, 2023, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer and Robert Lütjens, Head of Discovery – Biology will deliver a brief presentation followed by a Q&A session.
Joining the Conference Call:
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Online Registration: https://register.vevent.com/register/BI8f6a1aee693c405ebc85b10adfa18648
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