Protagenic Therapeutics(US:PTIX)2024-04-02 01:32Financial Data and Key Metrics Changes - In Q4 2023, the company spent $1.0 million on R&D, a 301% increase from $258,000 in Q4 2022 [23] - For the full year 2023, R&D expenses totaled $3.3 million, up 109% from $1.6 million in 2022 [24] - The company reported a net loss of $4.5 million for the full year 2023, a 27% increase compared to the previous year [38] - Cash and cash equivalents at year-end 2023 were $4.1 million, down from $8.0 million at the end of 2022 [25] Business Line Data and Key Metrics Changes - The company has initiated clinical trials for PT00114, focusing on neuropsychiatric disorders, which marks a significant operational shift [81] - R&D spending reflects the commitment to advancing PT00114, with no sales and marketing expenses reported as the company is not yet in the market [78] Market Data and Key Metrics Changes - The company is targeting a broad range of mental health conditions, including anxiety, depression, PTSD, and addiction, with PT00114 showing promise in preclinical studies [67][70] Company Strategy and Development Direction - The company aims to efficiently execute the Phase 1 clinical program and prepare for proof-of-concept efficacy studies in 2024 [26] - There is a focus on understanding the pharmacology of PT00114 to facilitate its transition from bench to bedside [32] - The strategy includes collecting biomarker data to support the efficacy of PT00114 in clinical trials [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the therapeutic potential of PT00114, emphasizing its novel mechanism of action and safety profile [40][84] - The ongoing mental health crisis, exacerbated by COVID-19, presents an urgent need for effective treatments, which the company aims to address [41] Other Important Information - The company has transitioned into a clinical-stage biotech firm, marking a pivotal year in its history [81] - The mechanism of action of PT00114 is distinct from existing treatments, potentially offering fewer side effects and improved outcomes [64][70] Q&A Session Summary Question: Timeline for SAD and MAD studies readout and next regulatory steps - The SAD study is in progress, with enrollment expected to complete by the end of April, and data readout anticipated by mid-May [45] - The Phase 2 protocol is being finalized for submission to regulatory agencies, with confidence in the compound's safety [48] Question: Expectations for biomarker data from initial trials - The company plans to announce cortisol levels alongside SAD and MAD results, indicating a focus on collecting relevant biomarker data [51]