PTIX

Key Points

• Protagenic initiated its first-ever clinical trial of lead product PT00114 in 2023. PT00114 is an analog of TCAP with a novel mechanism targeting stress response and emotional processing for conditions like depression, chronic anxiety, PTSD, and drug addiction.
• Preclinical research supports PT00114's potential in treating various neuropsychiatric disorders and neurodegeneration.
• Current clinical trials include SAD (single ascending dose) and MAD (multiple ascending dose) studies in normal healthy volunteers to determine efficacious dosing. PT00114 has a broad therapeutic window, well-defined dose response, and is safe with minimal side effects observed in preclinical studies.

Forward-Looking Statements

• SAD study enrollment to complete by end of April, with data readout expected by mid-May.
• MAD study to start immediately after SAD completion, with data readout anticipated in early Q3.
• Plan to finalize Phase 2 protocol and submit to regulatory agency for approval, utilizing a basket trial design to evaluate activity across neuropsychiatric disorders.

Risks

• Forward-looking statements subject to risks and uncertainties as outlined in the annual report on Form 10-K, including potential differences between actual results and forecasts related to clinical trial outcomes, regulatory approvals, and commercialization.

Q: Timeline for the readout of your SAD and MAD studies if we should be expecting those together, combined, or apart? And then what are the next regulatory steps that you have for moving forward into your Phase 2 studies?

A: SAD enrollment to complete by end of April, data readout by mid-May; MAD to start immediately after SAD, data readout in early Q3. For regulatory steps, finalizing Phase 2 protocol and submitting to regulatory agency, using a basket trial design to evaluate activity across neuropsychiatric disorders.

Q: Should we be expecting any biomarker data from these initial trials, maybe highlighting the neuroprotective effects?

A: Cortisol levels will be measured and included in disclosed results for SAD and MAD studies.