Financial Data and Key Metrics Changes - As of December 31, 2021, the company had a cash balance of $16.5 million, an increase of $1.1 million compared to December 31, 2020 [8][9] - The net loss for the year ending December 31, 2021, was $11.4 million or $0.75 per share, a reduction from a net loss of $14.4 million or $2.54 per share for the same period in 2020 [13] - Research and development expenses totaled $6.9 million for 2021, compared to $3.2 million for the same period in 2020, indicating a significant increase in R&D costs [15][16] Business Line Data and Key Metrics Changes - The company licensed PCS3117 from Ocuphire for cash and stock totaling $567,000, contrasting with $8.7 million in costs incurred for other licensing activities [14] - General and administrative expenses increased to $4.7 million in 2021 from $3.3 million in 2020, primarily due to higher professional fees and non-cash stock-based compensation [16] Market Data and Key Metrics Changes - The company is focused on five drugs in its pipeline, each addressing a different unmet medical need with a potential market size exceeding $1 billion [21][22] - The market potential for PCS499, aimed at treating necrobiosis lipoidica, is estimated to be around $1 billion, despite the challenges in patient enrollment due to COVID-19 [36][40] Company Strategy and Development Direction - The company is developing five drugs simultaneously, all at different stages, with multiple near-term milestones expected from March to August 2022 [22][23] - The strategy includes a focus on regulatory science to navigate FDA requirements effectively, leveraging past experiences with FDA contracts [22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by COVID-19 on patient enrollment but emphasized ongoing efforts to improve recruitment through advertising and physician referrals [50][66] - The company anticipates continued increases in clinical trial costs as it progresses with its drug development activities [15] Other Important Information - A purchase agreement with Lincoln Park Capital LP allows the company to sell up to $15 million worth of common stock over the next three years, serving as a financing insurance policy [12] - The company has modified the Phase 1b protocol for the next-generation capecitabine to better understand DPD inhibition and de novo formation timelines [34] Q&A Session Summary Question: Clarification on PCS499 prevalence estimates - Management noted that while literature suggests a prevalence of 22,000 to 55,000 patients, the actual interest in enrollment has been lower, prompting remedial actions to increase recruitment [49][50] Question: Pricing flexibility based on prevalence - Management indicated that the seriousness of the condition provides pricing flexibility, estimating a potential price range of $30,000 to $50,000 per year for patients [51][54] Question: Update on prescreening patients - Management confirmed that a couple of patients died from COVID before screening, affecting the number of patients in prescreening [55][56] Question: Data expectations for DPD inhibition - Management expects to gather data on DPD inhibition timelines by mid-2022, which will inform dosing regimens for the next-generation capecitabine [58] Question: Efficacy signal for 6422 - Management clarified that the 10% estimate for 5-FU metabolism is based on previous preclinical and clinical studies [63][64] Question: Enrollment criteria for PCS499 - Management stated that the exclusion of patients was not due to strict ulcer size criteria but rather other health conditions [65][66] Question: Therapeutic window for next-generation capecitabine - Management indicated that while monitoring for neurotoxicity and cardiotoxicity, they do not expect these to limit the maximum tolerated dose [78][80] Question: Establishing maximum tolerated dose - Management explained that the focus will be on determining the maximum tolerated dose of capecitabine, with adjustments based on DPD inhibition kinetics [82][85]
Processa Pharmaceuticals(PCSA) - 2021 Q4 - Earnings Call Transcript