Processa Pharmaceuticals, Inc. Q2 FY2022 earnings call

• Processa is a drug development company focused on unmet medical needs, with 5 in-licensed drugs targeting $1B+ markets. • 4 drugs have IND, 3 in clinical trials. Next Generation Capecitabine (6422) delayed due to regulatory hoops; 499 enrollment affected by COVID, with supplemental programs implemented; 12852 nearly enrolled, expects top-line results by end 2022. • Addressed investor questions on program progress, eligibility criteria, resource allocation, and plans for asset partnerships and funding (licensing/partnerships or additional offerings).

No detailed product segment financial performance with revenue contribution % provided. Cash balance at June 30, 2022 was $12.1 million. Net loss for 6 months ended June 30, 2022 was $8.4 million. Research and development costs for 6 months ended June 30, 2022 were $5.2 million, up $2.1 million from 2021. General and administrative expenses were $3.2 million, up from $2.1 million in 2021.

• Anticipate clinical trial costs to continue increasing as trials progress. • Hope to initiate next Next Generation Capecitabine clinical trial by end 2023. • 499 expects interim results in first half 2023, final study analysis in 2023; plan to meet FDA in 2023. • 12852 expects final top-line results by end 2022, moving to Phase 2B in 2023. • Funding for next trials from licensing/partnership or additional offerings.

• Uncertainties in clinical trial timelines due to regulatory hurdles and COVID impact on enrollment. • Risk of dilution from potential additional offerings. • Uncertainty in the timeline for completing macromolecule assay development for 3117.

Q: On 499, about screening failure rate and enrollment?

A: Screening failure rate not high; issue is few patients coming to screening due to COVID, with supplemental programs initiated to increase visibility.

Q: On 6422 preliminary results timeline?

A: Still sometime this summer, likely August or early September for interim results from new cohorts, enrollment expected to finish by end of year.

Q: On 3117 macromolecule assay development and FDA meeting timeline?

A: Working on assay, timing uncertain; expect to meet FDA beginning of 2023 once assay is further along.

Q: On 12852 top-line data and open-labeled portion?

A: Top-line data expected end 2022, first on gastric emptying rate in October, then symptomology later; no open-labeled portion currently.