PT00114 / Protagenic Therap - LARVOL DELTA

Protagenic Therapeutics Announces Second Quarter 2021 Results and Provides Business Update (GlobeNewswire) - "Anticipated Upcoming Milestones....Q1 2022: Initiation of Phase I/IIa study for PT00114; 1H 2022: Initial Data Readout of Phase I/IIa study."

New P1/2 trial • P1/2 data • CNS Disorders • Depression • Major Depressive Disorder

Protagenic Therapeutics To Start Clinical Trials For Depression Candidate By 2021 End (Benzinga) - "Upon reviewing Protagenic Therapeutics Inc's...Investigational New Drug (IND) application for its lead compound, PT00114, the FDA has currently rejected the Company's IND. The application sought approval to start a Phase 1/2a basket study designed to test PT00114 in healthy volunteers and patients with PTSD, anxiety, and depression. The agency has asked the Company to provide clinical sites with ready-to-inject clinical vials rather than providing site pharmacies with drug substances to be formulated locally. Protagenic is immediately implementing the necessary change: hence it expects to refile its IND and commence patient enrollment in Q4 of 2021 against 1H of 2021."

IND • New P1 trial • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Post-traumatic Stress Disorder

Dr. Maurizio Fava of Massachusetts General Hospital to Serve as Principal Investigator for PT00114 Clinical Trial (GlobeNewswire) - "Clinical Trials of First-in-Class Peptide to Commence in 1H 2021....Dr. Maurizio Fava...will serve as the principal investigator in its upcoming clinical trial, a Phase 1/2a basket study designed to test PT00114 in healthy volunteers and patients with PTSD, Anxiety and Depression....'It is our hope that PT00114 will emerge as a new medicine for these conditions'...Protagenic Therapeutics recently completed a two-species GLP toxicology study as part of the company’s progress toward an IND filing with the FDA. PT00114 produced no observable signs of toxicity at four weeks post-injection in both a rat and non-human primate."

New P1/2 trial • Preclinical • CNS Disorders • Depression • General Anxiety Disorder • Post-traumatic Stress Disorder

Protagenic Therapeutics Completes $2.0 Million Convertible Note Financing (GlobeNewswire) - "Protagenic Therapeutics, Inc....announced today that it has completed a convertible note financing, raising its target amount of $2.0 million. The capital will be used to complete the last remaining components of the Company’s investigational New Drug (IND) filing with the FDA for its lead drug compound, PT00114....The company plans to submit its IND application to the FDA in 1Q 2021. Upon successful IND submission and acceptance by the FDA, the Company plans to sponsor a Phase I clinical trial in the first half of 2021."

Financing • IND • New P1 trial • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Post-traumatic Stress Disorder