Processa Pharmaceuticals, Inc. Q3 FY2022 earnings call

• Processa reported positive results from Phase 1B trial for PCS6422 in GI cancer and Phase 2A trial for PCS12852 in gastroparesis. - For Next Generation Capecitabine (6422), identified dosage regimens and 5 - FU exposures in the ongoing Phase 1B trial, determined new DPD formation timeline is approximately 24 hours to 72 hours after dose, potency increased to 50 times that of approved capecitabine, and plans to initiate an efficacy/safety Phase 2B trial in 2023. - For PCS12852, Phase 2A trial in gastroparesis showed change in gastric emptying rate after 28 days of 0.5 milligrams treatment was statistically better than placebo at p - value < 0.1, symptoms analysis expected by end of year, and plans to initiate an efficacy/safety Phase 2B trial in 2023. - Executive officers invested majority of base salary for company stock to conserve cash.

Cash balance at September 30, 2022 was $9.1 million. During the nine months ended September 30, 2022, cash spent for clinical trials and operations was $7.1 million. GAAP net loss for the nine months ended September 30, 2022 was $14.4 million. Research and development costs for the nine months ended September 30, 2022 were $8.3 million, an increase of $3.5 million compared to the same period in 2021. General and administrative expenses totaled $6.1 million compared to $3.4 million for the same period in 2021.

• Cash balance of $9.1 million at September 30, 2022 is sufficient to complete three ongoing clinical trials and fund operations into the third quarter of 2023. - Processa plans to initiate an efficacy/safety Phase 2B trial for Next Generation Capecitabine in 2023 following FDA's Project Optimus Initiative. - Plans to initiate an efficacy/safety Phase 2B trial for PCS12852 in gastroparesis in 2023.

• Actual results may differ materially from forward - looking statements due to various risks and uncertainties. - Difficulty in patient recruitment, such as issues in defining ulcerative NL and miscommunication about patient conditions.

Q: What is the significance of the p - value being less than 0.1?

A: The p - value less than 0.1 indicates less than a 10% probability that the results occurred by chance, showing a strong trend in the proof - of - concept trial for PCS12852.

Q: Is the Optimus project something that could potentially require multiple phases?

A: For cancer indication, typically do one Phase 2B and then go to Phase 3, similar to other indications where balance between efficacy and safety is sought.

Q: What are the thoughts on the 0.5 milligrams and 0.1 milligrams in the gastroparesis drug?

A: Chose 0.1 milligram to show a non - effective dose, thought 0.5 milligram was more likely to be effective based on data.

Q: On the gastroparesis drug, what were thoughts on 0.5 milligrams being significant and 1.0 milligrams?

A: Chose 0.1 milligram as there was a chance it could be non - effective, thought 0.5 milligram was more likely effective.

Q: In terms of safety, thoughts on how high can go with gastroparesis drug?

A: From tox and other data, 0.5 milligrams and 1.0 milligrams are equally safe, and could consider going higher than 0.5 milligrams but not too much higher.