Core Viewpoint - Processa Pharmaceuticals, Inc. has announced a public offering aimed at raising funds to support its development of next-generation chemotherapeutic drugs with enhanced efficacy and safety [1][8]. Group 1: Offering Details - The public offering consists of 8,050,672 shares of common stock and accompanying Series A and Series B warrants, with a combined purchase price of $0.615 for institutional investors and $0.7975 for the CEO and certain board members [1]. - The gross proceeds from the offering are expected to be $5 million, excluding any proceeds from the exercise of the Series A and Series B warrants [3]. - The offering is anticipated to close on or about January 29, 2025, pending customary closing conditions [3]. Group 2: Warrants Information - Series A warrants will have an exercise price of $0.65 per share, exercisable upon stockholder approval and expiring five years from that date [2]. - Series B warrants will also have an exercise price of $0.65 per share, exercisable upon stockholder approval and expiring eighteen months from that date [2]. - The company plans to seek stockholder approval for the issuance of shares upon the exercise of these warrants within 90 days after the offering [4]. Group 3: Company Overview - Processa Pharmaceuticals is focused on developing Next Generation Chemotherapy (NGC) drugs that modify existing FDA-approved oncology therapies to improve safety and efficacy [8]. - The company's strategy involves combining its oncology pipeline with proven cancer-killing molecules to create more effective therapy options for cancer patients [8].

Core Insights - Processa Pharmaceuticals, Inc. is actively participating in multiple investor and industry conferences in September 2024, including the H.C. Wainwright 26th Annual Global Investment Conference and the European Society for Medical Oncology (ESMO) Congress 2024 [1][2] Group 1: Conference Participation - Management will hold one-on-one meetings with investors and deliver a company presentation at the H.C. Wainwright conference from September 9-11, 2024 [1] - A recorded presentation will be available on demand starting September 9th at 7:00 am Eastern time on the company's website [1] - At the ESMO Congress from September 13-17, 2024, management will engage with clinicians, researchers, industry key opinion leaders, and potential partners [1] Group 2: Company Overview - Processa is a clinical-stage pharmaceutical company focused on developing Next Generation Chemotherapy (NGC) drugs that offer improved safety and efficacy [2] - The NGC drugs are modifications of existing FDA-approved oncology therapies, altering their metabolism and/or distribution while preserving their cancer-killing mechanisms [2] - The company's strategy combines a novel oncology pipeline with proven active molecules and a Regulatory Science Approach to create more effective therapy options with better tolerability for cancer patients [2]

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].

At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD) HANOVER, MD., June 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical tria ...

Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 months Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs to improve the safety and efficacy of cancer treatment. By combining its novel oncology pipeline with proven cancer-killing active molecules and the Processa Regulatory Science Approach, as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will pro ...

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].

Financial Performance - In 2023, the company reported an operating loss of $11,457,061, a decrease from the operating loss of $27,525,431 in 2022, reflecting a reduction in operating expenses [302]. - The company had no revenue for the years ended December 31, 2023 and 2022, with no immediate sales prospects [303]. - The company reported a net loss of approximately $11.1 million for the year ended December 31, 2023, with an accumulated deficit of approximately $75.4 million [317]. - Net cash used in operating activities was $8,063,346 for the year ended December 31, 2023, compared to $9,605,143 in 2022, reflecting ongoing clinical trial costs [321]. Research and Development - Research and development costs decreased by $5.7 million to $5,799,518 in 2023, down from $11,494,230 in 2022, primarily due to the completion of the PCS12852 clinical trial and the termination of the PCS499 trial [305]. - The company completed its Phase 2A trial for PCS12852 in gastroparesis patients with positive results in 2023 [299]. - The company plans to conduct IND-enabling and toxicology studies for NGC-Iri in 2024-2025, targeting various cancers [299]. - The estimated annual newly diagnosed incidence rate for breast, colorectal, and other cancers relevant to NGC-Cap is greater than 250,000 patients per year [299]. Capital and Funding - The company raised gross proceeds of $7.0 million from a public offering on January 30, 2024, with net proceeds of $6.3 million intended for continued research and development for NGC-Cap [301]. - The company anticipates needing to raise additional capital in early 2025 to fund operations and continue the development of NGC drugs [307]. - Cash and cash equivalents totaled $4.7 million as of December 31, 2023, with an additional $6.3 million raised in January 2024 from a public offering [316]. - The company has an effective shelf registration statement on file with the SEC, providing flexibility to raise capital through public or private equity offerings [319]. Expenses and Impairments - General and administrative expenses decreased by $3.1 million to $5,657,543 for the year ended December 31, 2023, compared to $8,763,058 in 2022, primarily due to a reduction in employee stock-based compensation [311]. - The company recognized an impairment of $7.3 million for the PCS499 intangible asset, reducing its value to zero, due to slow patient enrollment and the decision to terminate the clinical trial [313]. - Stock-based compensation expense is recognized over the requisite service period based on estimated grant-date fair value, with no expense recognized for performance-vesting conditions until probable [335]. Tax and Deferred Assets - A valuation allowance equal to the full recorded amount of net deferred tax assets has been maintained, indicating that benefits from these assets are unlikely to be realized [337]. - The company does not expect to generate income tax benefits or expenses in the foreseeable future due to anticipated net operating losses [337]. - No unrecognized tax benefits were recorded as of December 31, 2023, indicating no liability, interest, or penalties required [338]. Other Financial Information - Net other income increased to $335,541 for the year ended December 31, 2023, compared to $101,202 in 2022, primarily driven by interest income [314]. - The company raised net proceeds of $6.4 million from the sale of common stock during the year ended December 31, 2023 [324]. - Prepaid expenses included $570,000 for advanced payments made to the CRO for the NGC-Cap clinical trial as of December 31, 2023 [310]. - Payments made to third parties in advance of services are recorded as prepaid expenses until the services are rendered [334].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (State ...