Processa Pharmaceuticals(US:PCSA)2021-05-14 11:37Financial Data and Key Metrics Changes - The company reported a net loss of $2.1 million or $0.14 per share for Q1 2021, compared to a net loss of $874,000 or $0.16 per share for the same period in 2020, indicating an increase in net loss primarily due to higher clinical trial costs [7] - Net cash used in operating activities increased by $1.7 million to $2.2 million in Q1 2021 compared to Q1 2020, attributed to costs related to clinical trials [8] - Research and development expenses totaled $1.5 million in Q1 2021, up from $502,000 in Q1 2020, reflecting increased trial preparations [10] - General and administrative expenses rose to $717,000 in Q1 2021 from $484,000 in Q1 2020, with $308,000 allocated to non-cash compensation costs [11] Business Line Data and Key Metrics Changes - The company is actively working on four drugs: PCS6422 for metastatic colorectal cancer, PCS499 for ulcerative necrobiosis lipoidica, 11T for cancer, and 12852 for gastroparesis, each with significant market potential [23] - PCS6422 is in Phase 1b trials, while PCS499 is in Phase 2b trials, with both drugs targeting large markets exceeding $1 billion [23][27] Market Data and Key Metrics Changes - The potential market for PCS6422, when combined with capecitabine, is estimated to be between $700 million to $1.5 billion for metastatic colorectal cancer, with broader applications potentially leading to multiple billions [27] - PCS499 has a potential market of $600 million to $1.4 billion, as it targets a condition with no approved treatments [33] Company Strategy and Development Direction - The company aims to develop drugs with a high return using a derisked approach, focusing on unmet medical needs and competitive advantages [18][19] - The strategy includes leveraging previous work on drugs to streamline the approval process and ensuring capital efficiency [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving clinical development goals and anticipates increased cash burn as trials progress [72] - The company expects to enroll the first patient in the PCS499 trial within 10 to 45 days and anticipates significant milestones over the next six months [40] Other Important Information - The company raised $10.2 million in a private offering in February 2021, providing additional cash to support studies and overhead through 2023 [9][17] - The company plans to hire additional staff to support drug development and corporate requirements over the next 12 months [17] Q&A Session Summary Question: Update on clinical sites for 6422 and 499 - Management confirmed five U.S. sites for PCS499 and plans to add three to four more, while expecting four to five sites for PCS6422 [46][47] Question: Data expected from interim analysis - For PCS6422, the interim analysis will focus on confirming the dosing regimen and tolerability, while for PCS499, the expectation is to see differences between treated and placebo groups [50][51] Question: Competing drugs for PCS499 - Management discussed off-label drugs like topical steroids and pentoxifylline, noting mixed results and side effects associated with current treatments [66][68] Question: Financial burn rate expectations - Management expects the cash burn rate to increase as clinical trials commence, with some of the current burn attributed to upfront costs for CROs [72][73] Question: Future milestones and updates - Management indicated that updates on patient enrollment and any serious adverse events will be provided in future calls, with the possibility of interim results by early 2022 [76][78]