Processa Pharmaceuticals (PCSA) Q2 2024 earnings summary

Executive summary

• Focused on developing next-generation chemotherapy (NGC) drugs using a regulatory science approach, with a pipeline including NGC-Cap, NGC-Gem, and NGC-Iri targeting various solid tumors.

• Advanced three development programs, with NGC-Cap Phase 2 trial in metastatic breast cancer initiated after FDA clearance in July 2024; other assets are in preclinical or planning stages.

• NGC-Cap Phase 1b showed favorable safety and preliminary anti-tumor activity in advanced GI cancer, with 66.7% of evaluable patients achieving partial response or stable disease.

• Preclinical studies for NGC-Iri demonstrated higher tumor delivery of SN-38 and lower non-cancer tissue exposure, suggesting improved efficacy and safety.

• No product revenue generated to date; operations funded primarily through equity offerings.

Financial highlights

• Cash and cash equivalents were $5.6 million as of June 30, 2024, up from $4.7 million at December 31, 2023.

• Net loss for Q2 2024 was $3.0 million ($1.01 per share), compared to $2.6 million ($1.94 per share) in Q2 2023; net loss for the first half of 2024 was $5.7 million, down from $6.6 million year-over-year.

• Operating expenses for Q2 2024 included $1.7 million in R&D and $1.4 million in G&A, with G&A up from $1.0 million in Q2 2023 due to higher professional fees.

• Net cash used in operating activities was $5.4 million for the six months ended June 30, 2024; net cash provided by financing activities was $6.3 million.

Outlook and guidance

• Current cash is expected to fund operations into late 2024, including the start of the Phase 2 NGC-Cap trial.

• Initial data readout from the NGC-Cap Phase 2 breast cancer trial expected in mid-2025.

• Plans to meet with FDA in late 2024 or early 2025 to discuss NGC-Gem trial designs; IND-enabling toxicology studies for NGC-Iri anticipated in 2025.

• Additional funding will be required to support longer-term plans and further clinical development.

• An at-the-market (ATM) equity offering facility for up to $2.4 million was established in May 2024.