Addex Therapeutics(US:ADXN)2022-03-11 04:02Financial Data and Key Metrics Changes - In 2021, the company recognized $3.2 million in revenue, an increase from $2.9 million in 2020, primarily from research funding with Indivior [23] - R&D expenses rose to $12.8 million, up by $2.5 million compared to 2020, due to increased activities in the Dipraglurant and GABAB PAM programs [23] - G&A expenses were $5.8 million, slightly up from $5.7 million in 2020, attributed to higher insurance premiums [24] - The company ended the year with a cash position of CHF20.5 million, equivalent to $22.5 million [6][25] Business Line Data and Key Metrics Changes - The company has three clinical programs actively dosing patients, including Dipraglurant for blepharospasm and dyskinesia associated with Parkinson's Disease [3][26] - The pivotal Phase 2b/3 study for Dipraglurant in PD-LID began in Q2 2021, enrolling 140 patients [7] - The exploratory study for blepharospasm involves 15 patients and is expected to report data in Q2 2022 [12] Market Data and Key Metrics Changes - The market opportunity for Dipraglurant in dyskinesia associated with Parkinson's Disease is described as multi-billion dollars [7] - There are approximately 50,000 patients in the U.S. suffering from blepharospasm, with about 2,000 new cases annually [51] Company Strategy and Development Direction - The company aims to maintain the integrity and quality of its clinical studies despite delays caused by the pandemic [4] - A strategic collaboration with Indivior was extended, with an additional $4 million committed for research funding [5] - The company is focused on advancing multiple preclinical programs, including mGlu7 NAM for PTSD and mGlu2 NAM for mild neurocognitive disorders [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for significant data readouts in 2022 [27] - The company anticipates a promising outlook, highlighting the undervalued equity story and the potential for partnerships as clinical data emerges [27] Other Important Information - The company has made significant progress in its preclinical portfolio, with multiple drug candidates advancing towards IND-enabling studies [22] - The company is exploring non-dilutive funding opportunities for its PTSD program, which has garnered interest from governmental entities [43] Q&A Session Summary Question: Is enrollment for the PD-LID Dipraglurant study hastening as the Omicron wave recedes? - Management noted good momentum in enrollment as COVID impacts lessen, with encouraging activity across various sites [30] Question: What is the strategic positioning for Dipraglurant regarding different indications? - Management indicated that data from the blepharospasm study will inform future development strategies, with a focus on a strong signal from the exploratory study [35] Question: What is the timing for Indivior's decision on extending the collaboration? - The collaboration is currently under review, with discussions expected as the program reaches advanced stages of clinical candidate selection [42] Question: Can you provide guidance on cash burn and cash reach? - The company reported a cash burn of approximately CHF1.5 million per month, guiding cash availability into the first half of 2023 [46] Question: What is the market potential for the blepharospasm indication? - The company estimates around 50,000 patients in the U.S. with blepharospasm, highlighting the impactful nature of the condition [51] Question: When can we expect lead candidates in clinical trials for the GABAB PAM program? - The company anticipates moving candidates into IND-enabling studies by the end of 2022, with Phase 1 trials potentially starting in late 2023 [55] Question: Will positive results from the ADX71149 epilepsy study trigger a milestone payment? - Management clarified that the last milestone was received when the program entered Phase 2, and no further details on future milestones could be provided [58][59]