Processa Pharmaceuticals(US:PCSA)2022-08-14 10:13Financial Data and Key Metrics Changes - The cash balance as of June 30, 2022, was $12.1 million, expected to fund operations into Q3 2023 [8] - The net loss for the six months ended June 30, 2022, was $8.4 million, or $0.53 per share, compared to a net loss of $5.3 million, or $0.35 per share for the same period in 2021, indicating an increase in net loss due to higher clinical trial costs [10][11] - Research and development costs for the six months ended June 30, 2022, totaled $5.2 million, an increase of $2.1 million compared to the same period in 2021 [11] - General and administrative expenses totaled $3.2 million for the six months ended June 30, 2022, compared to $2.1 million for the same period in 2021, primarily due to increases in stock-based compensation [12] Business Line Data and Key Metrics Changes - The company has three drugs in clinical trials: Next Generation Capecitabine (6422), drug 499, and drug 12852, with varying enrollment and progress rates [20][24] - Drug 499 has faced slower patient enrollment, significantly affected by COVID-19, while drug 12852 has performed well in patient enrollment [20][27] Market Data and Key Metrics Changes - The potential market size for each of the five drugs in the pipeline is greater than $1 billion, providing multiple opportunities for significant revenue generation [18] - The company is focused on patients with unmet medical needs, indicating a strategic positioning in a niche market [17] Company Strategy and Development Direction - The company aims to out-license or partner each drug when the benefits outweigh the risks, with interest already expressed by several companies [34] - Funding for future studies is expected to come from licensing deals and additional cash offerings, with a focus on increasing the company's market cap before raising funds [35] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in patient enrollment due to COVID-19 but is implementing strategies to improve visibility and recruitment for clinical trials [20][30] - The company expects to complete enrollment for its trials and achieve key milestones within the next 12 months, with positive news flow anticipated [36] Other Important Information - The company has brought in additional staff to manage clinical studies efficiently and is prepared to hire more if necessary [32] - Management emphasized their vested interest in the company's success, having invested their own cash and salaries into the business [37] Q&A Session Summary Question: What is the status of drug 499 regarding patient screening? - Management indicated that the screening failure rate is not high, but there are very few patients coming in for screening, primarily due to COVID-19 [39] Question: Are there signs of increased interest since the launch of the website? - Management confirmed that there has been an increase in patient inquiries following the website launch and other initiatives [41] Question: What is the new timeline for preliminary results of drug 6422? - Management expects to have interim results by late summer, with overall study completion still on track for the end of the year [42] Question: What is the status of drug 3117's assay development? - Management is still working on the assay and plans to meet with the FDA in early 2023, depending on the assay's progress [47] Question: What can be expected from the top-line data for drug 12852? - Management anticipates top-line data regarding gastric emptying rates by October, with a full analysis of symptoms expected later [50]