Processa Pharmaceuticals, Inc. Q3 FY2021 earnings call

• Jim Stanker discussed financial results, cash management, noting cash balance of $19.1 million as of Sep 30, 2021, net loss details, R&D and G&A expense changes.
• David Young provided pipeline updates: Next Generation Capecitabine (6422) interim Phase 1b data showed >50x potency, modified Phase 1b protocol to understand DPD inhibition timeline; 499 Phase 2b trial with FDA orphan designation, interim analysis expected mid-2022; 12852 Phase 2a trial received study to proceed letter from FDA, expected to enroll first patient in first half of 2022.

For the third quarter of 2021, Processa reported a net loss of $3 million or $0.19 per share compared to a net loss of $3.1 million or $0.55 per share in the same period of 2020. Research and development expenses in Q3 2021 totaled $1.7 million, up from $533,000 in Q3 2020. General and administrative expenses were $1.3 million in Q3 2021, compared to $424,000 in Q3 2020. As of September 30, 2021, cash balance was $19.1 million. During the nine months ended September 30, 2021, cash balance increased by $3.7 million from December 31, 2020.

• Costs expected to continue increasing as clinical trials progress.
• Timeline for Phase 3 and approval for 6422 remains unchanged.
• 499 interim analysis expected in mid-2022, Phase 3 trial to start in 2023.
• 12852 Phase 2a trial to begin enrollment in first half of 2022.
• Potential regulatory submissions for pipeline drugs within next 6-9 months.

• Uncertainties in clinical trial outcomes and efficacy.
• Risks related to regulatory approvals and the timeline for drug development.
• Uncertainties in achieving expected potency and safety profiles for pipeline drugs.

Q: On 6422, was the preclinical data hinting at the 50x concentration seen in clinical data?

A: David Young said preclinical data hinted at greater potency but not the 50x seen.

Q: For 499 interim data, how many patients, doses, and what info?

A: Interim analysis expected 8-10 patients at max dose of 1.8 grams per day; key is placebo group response to drive regulatory submission decisions.

Q: On 6422 safety, concerns about neutropenia and side effects?

A: David Young said need to evaluate, gut feeling DLT related to nucleotides like neutropenia and GI effects.

Q: On 499 enrollment slowdown, reasons and interim analysis timeline?

A: Enrollment slower due to need for national recruiting push; interim analysis completion expected in first quarter 2022, full enrollment by June 2022.

Q: On 6422 dosing regimens and approval timeline?

A: Will increase dosing of 6422 during capecitabine dosing; hope to expedite approval by pushing data with FDA.