Processa Pharmaceuticals, Inc. Q1 FY2022 earnings call

• Processa is a drug development company focused on improving patients' lives with unmet medical needs, with five drugs in pipeline each targeting over $1B market.
• Key milestones achieved in Q1 2022: Amended Phase 1B protocol for next gen capecitabine, expanded outreach for PCS499, enrolled 5 patients in PCS12852 trial, began developing assays for PCS3117.
• Updates on individual drugs: Next gen capecitabine amended protocol enrolled patients, PCS499 expanded enrollment efforts despite COVID, PCS12852 on track for enrollment completion by Sept-Oct and top line data by year-end, PCS3117 developing biomarkers for patient response prediction.

As of March 31, 2022, Processa Pharmaceuticals had a cash balance of $14.3 million. For the three months ended March 31, 2022, the net loss was $3.2 million or $0.20 per share, compared to a net loss of $2.1 million or $0.14 per share in the same period of 2021. Research and development expenses totaled $2 million in Q1 2022, up from $1.5 million in Q1 2021. G&A expenses were $1.2 million in Q1 2022, compared to $700,000 in Q1 2021.

• Expect clinical trial costs to continue increasing as trials progress.
• Mid-2022 expected milestones: Identify dosage regimen for next gen capecitabine, complete enrollment and interim analysis for PCS499, complete biomarker assay development for PCS3117.
• Year-end expected milestones: Top line data from PCS499 interim analysis, enrollment completion for PCS499, roadmaps for PCS3117 development, meeting with FDA for PCS3117.

• COVID impact on enrollment for PCS499.
• Potential delays in clinical trials due to regulatory or unforeseen clinical issues.
• Uncertainty in achieving expected efficacy and safety results for trial endpoints.

Q: About PCS3117, is there a smaller indication for shorter regulatory pathway?

A: Yes, evaluating subpopulations like third line therapy pancreatic cancer and will develop roadmaps and meet FDA to determine most likely approved path.

Q: For next gen capecitabine, preview of mid-year interim data?

A: Will look at potency across dosing days and metabolism of non-cancer killing metabolites causing side effects, expecting to identify regimen with high potency and low side effects.

Q: Update on PCS499 enrollment efforts?

A: Expanded efforts but still impacted by COVID, but confident in enrollment progress with pre-screening and site evaluations, though COVID resurgence could delay.

Q: On PCS3117 biomarker assay completion and FDA meeting?

A: Planning FDA meeting end of year, biomarker assay development mid-2022, preparing roadmaps for study designs.

Q: For PCS499, considering lower patient numbers for trial?

A: Discussed with FDA, possible to decrease sample size if placebo group response is low, hoping for close to zero response in placebo group to allow smaller sample size.