Financial Performance - For the three months ended June 30, 2024, the company reported a net loss of $3,010,326, compared to a net loss of $2,612,565 in the same period of 2023[67]. - Research and development expenses for the six months ended June 30, 2024, totaled $3,269,555, a decrease of $72,954 from $3,342,509 in 2023[67]. - General and administrative expenses decreased by approximately $855,000 to $2.6 million for the six months ended June 30, 2024, compared to $3.5 million in 2023[75]. - The company used net cash of $5,394,713 in operating activities during the six months ended June 30, 2024, up from $4,178,539 in 2023[76]. - The company had cash and cash equivalents of $5.6 million as of June 30, 2024, which is expected to meet operating needs into late 2024[81]. - The accumulated deficit reached $81.1 million as of June 30, 2024, with no product revenue generated to date[82]. - The company raised net proceeds of $6.3 million from the sale of common stock and warrants during the six months ended June 30, 2024[83]. Stock and Financing Activities - The company raised gross proceeds of $7.0 million (net proceeds of $6.3 million) from the sale of 476,000 shares in a public offering on January 30, 2024[64]. - The company filed a registration statement for an ATM offering of up to $50 million, with an initial offering price of $2.4 million[65]. - The company filed a registration statement with the SEC for an offering of up to $50 million in securities, including an "at the market offering" of common stock with an aggregate offering price of up to $2.4 million[84]. - Future funding plans include public or private equity offerings, debt financings, and strategic alliances, but the company may delay or suspend clinical trials if adequate financing is not obtained[85]. Corporate Governance - Russell Skibsted was appointed as CFO with an annual salary of $400,000 and a potential bonus of 35% of his base compensation[66]. Clinical Development - The company is advancing its pipeline of Next Generation Chemotherapy (NGC) drugs, including NGC-Cap, NGC-Gem, and NGC-Iri, which aim to improve safety and efficacy profiles compared to existing therapies[50]. - NGC-Cap has demonstrated up to 50 times greater potency than capecitabine alone in a Phase 1B trial, indicating a potentially improved safety-efficacy profile[54]. - The Phase 2 trial for NGC-Cap is set to initiate, comparing its safety-efficacy profile against FDA-approved capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer[57]. - The company plans to meet with the FDA to discuss trial designs for NGC-Gem, which is expected to offer benefits for patients resistant to gemcitabine[58]. - The company terminated the Phase 2 trial for PCS499 due to challenges in patient enrollment but completed a Phase 2A trial for PCS12852 with positive results[63]. - The company is committed to meeting specific diligence milestones for its licensing agreements, including dosing the first patient in a Phase 2 or 3 clinical trial for NGC-Cap by October 2, 2024[57]. - The company anticipates increased research and development costs as it begins its Phase 2 clinical trial for NGC-Cap in breast cancer[77]. Strategic Focus - The company is exploring options to monetize non-core drug assets, including out-licensing or partnering opportunities[63]. - The company’s strategic focus is on utilizing its Regulatory Science Approach to enhance the development of oncology drugs, aiming for greater efficiencies and improved chances of FDA approval[49]. Accounting and Reporting - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring estimates and judgments that may affect reported amounts of assets and liabilities[87]. - There have been no changes in critical accounting policies from the most recent Annual Report on Form 10-K, and actual results may differ from estimates used[88]. - Recently issued accounting pronouncements have been evaluated, showing no material impact on the company's financial position or results of operations[89]. - As of June 30, 2024, there were no off-balance sheet arrangements reported by the company[86].
Processa Pharmaceuticals(PCSA) - 2024 Q2 - Quarterly Report