Oncology Drug Development - The company is focused on developing Next Generation Chemotherapy (NGC) oncology drug products to improve patient survival and quality of life [59]. - NGC-Cap (PCS6422) is currently in Phase 1B trials, demonstrating up to 50 times greater potency than capecitabine alone [66]. - The Phase 1B trial for NGC-Cap has completed enrollment, and the recommended Phase 2 dosage regimens have been determined [68]. - The next Phase 2 trial for NGC-Cap will focus on breast cancer, with patient enrollment expected to begin in Q3 2024 [71]. - NGC-Gem (PCS3117) is being evaluated for its potential use in pancreatic and other cancers, with a meeting planned with the FDA in 2024 to discuss trial designs [73]. - The company is also developing NGC-Iri, an analog of SN38, with IND-enabling toxicology studies planned for 2024, subject to funding availability [73]. - The company aims to provide improved safety-efficacy profiles for its NGC products compared to existing therapies like capecitabine, gemcitabine, and irinotecan [62]. - The regulatory science approach utilized by the company is designed to enhance the likelihood of FDA approval and improve treatment options for patients [64]. Financial Performance - The company reported a net loss of $2,726,381 for the three months ended March 31, 2024, down from a net loss of $4,022,073 in the same period of 2023 [78]. - Research and development expenses decreased by $88,410 to $1,539,070 for the three months ended March 31, 2024, compared to $1,627,480 in the same period of 2023 [82]. - Operating expenses for the three months ended March 31, 2024, included $1,270,528 in general and administrative expenses, down from $2,478,055 in the same period of 2023 [87]. - The company has an accumulated deficit of $78.1 million as of March 31, 2024 [97]. - The company used net cash of $2,048,884 in operating activities during the three months ended March 31, 2024, compared to $2,114,070 in the same period of 2023 [92]. Funding and Capital Needs - The company raised gross proceeds of $7.0 million from a public offering on January 30, 2024, with net proceeds of $6.3 million [77]. - Cash and cash equivalents totaled $8.9 million as of March 31, 2024, which is expected to satisfy capital needs into early 2025 [96]. - The company anticipates an increase in research and development costs as it continues its Phase 1B clinical trial for NGC-Cap and begins its Phase 2 trial [83]. - The company plans to raise additional funds through public or private equity offerings, debt financings, and strategic alliances [99]. Other Developments - The company completed its Phase 2A trial for PCS12852 in gastroparesis patients with positive results in 2023 [75]. - The license agreement with Elion for NGC-Cap includes a milestone to dose the first patient in a Phase 2 or 3 clinical trial by October 2, 2024 [72]. - The company is exploring options for two non-oncology drugs, which may include out-licensing or partnership opportunities [63]. - Item 3 regarding quantitative and qualitative disclosures about market risk is not applicable to the company as a smaller reporting company and has been omitted [106].
Processa Pharmaceuticals(PCSA) - 2024 Q1 - Quarterly Report