Protagenic Therapeutics, Inc.

In Q4 2023, R&D was $1.0 million, up 301% from $258,000 in Q4 2022, while G&A was $201,000, described as down 50% versus the comparable quarter a year ago. Net loss for Q4 was $1.2 million versus a net loss of $656,000 in the prior-year quarter. For full-year 2023, R&D was $3.3 million, up 109% from $1.6 million in 2022, G&A was $1.2 million and down almost 40% from the year-ago period, and net loss was $4.5 million, 27% higher than in 2022. Cash and cash equivalents ended the year at $4.1 million versus $8.0 million at December 31, 2022. Management said current cash is sufficient to fund the Phase 1 clinical trial. Forward-looking milestones: SAD enrollment completion by the end of April with data readout by mid-May, MAD enrollment to start immediately after SAD and a readout in early Q3.

Garo Armen framed 2023 as the year Protagenic transformed into a clinical-stage biotech, centered on the initiation of its first in-human PT00114 trial. He stressed the drug’s novel mechanism, saying it targets stress-response and emotional-processing pathways with the goal of helping anxiety, depression, PTSD, and addiction, and he repeatedly described the program as a potential breakthrough. His tone was upbeat and confident, with an emphasis on moving efficiently through Phase 1 and into proof-of-concept studies in 2024.

Alex Arrow focused on the spending shift tied to the trial, highlighting that Q4 R&D rose to $1.0 million from $258,000 in the prior-year quarter and full-year R&D reached $3.3 million versus $1.6 million in 2022. He said G&A was $201,000 in Q4 and $1.2 million for the full year, helped by the absence of stock option issuance and minimal non-cash compensation compared with the prior year. He also noted the company ended 2023 with $4.1 million in cash and cash equivalents, down from $8.0 million, but still believes that cash is enough to fund the Phase 1 program.

The main analyst question from William Wood was about timing for SAD and MAD readouts and the regulatory path into Phase 2. Management said SAD enrollment should finish by the end of April, with readout by mid-May, and MAD data should come in early Q3; for Phase 2, they are finalizing the protocol and will submit it for agency approval. Wood also asked about biomarker data, and management said cortisol levels will be announced with both SAD and MAD results, while additional biomarker work is being collected in healthy volunteers.