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, 2025 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 ...

Core Viewpoint - Processa Pharmaceuticals, Inc. announced the acceptance of its abstract for PCS499, aimed at treating Focal Segmental Glomerulosclerosis (FSGS), for presentation at the ASN Kidney Week 2025, highlighting the urgency for new therapies in this area [1][4]. Group 1: Presentation Details - The poster for PCS499 will be presented on November 7, 2025, during the session "Glomerular Clinical Trials: From Data to Impact" [2]. - The specific poster board number for the presentation is FR-PO0829 [2]. Group 2: Product Information - PCS499 is an analog of a metabolite of pentoxifylline (PTX), which has shown efficacy in reducing proteinuria but is limited by dose-related side effects [3]. - PCS499 has a favorable safety profile compared to PTX, allowing for higher dosing and potentially greater therapeutic benefits for rare kidney diseases like FSGS [3]. Group 3: Company Overview - Processa Pharmaceuticals focuses on developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, aiming to improve safety and efficacy [6]. - The company modifies existing FDA-approved oncology therapies to enhance their metabolism and distribution while maintaining their cancer-killing mechanisms [6].

Processa Pharmaceuticals Inc. (NASDAQ:PCSA) shares soared 37.5% to $0.50 during after-hours trading on Tuesday. This came after a solid 29.03% gain during the regular session, closing at $0.36, according to Benzinga Pro data.Check out the current price of PCSA stock here. Despite this surge, the clinical-stage drug company has faced a tough year, with shares down 71.43% over the past 12 months and still down 59.09% year to date. However, the stock has shown signs of recovery more recently, gaining 50% over ...

Group 1: Telomir Pharmaceuticals Inc. (TELO) - Shares surged 43% in after-hours trading, climbing from $1.42 to $2.03 on light volume of 213,569 shares, below the average daily volume of 4.67 million [2] - The spike reflects renewed interest in recent in vitro data showing Telomir-1's ability to target additional histone demethylase families, indicating a unique epigenetic profile [3] Group 2: Processa Pharmaceuticals Inc. (PCSA) - Shares rose 32.6% in after-hours trading to $0.37, following a 30.9% gain during the regular session, with a closing price of $0.2790 on volume exceeding 31.9 million shares [4] - The price movement occurred without any official news or updates from the company, suggesting speculative momentum or technical positioning [5] Group 3: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Shares increased 33.7% in after-hours trading to $0.8950 after a regular session gain of 22.8%, closing at $0.6693 with significant trading volume of 34.2 million shares [6] - The rally happened despite no recent official news, with the last update being four days prior regarding a healthcare conference [7] Group 4: NeuroOne Medical Technologies Corp. (NMTC) - Shares rose 9.5% in after-hours trading to $1.09, extending a 7.1% gain during the regular session, with a closing price of $0.9956 and trading volume of 1.21 million shares [8] - The increase followed the announcement of preliminary unaudited product revenue of $9.1 million for fiscal year 2025, up 163% from the prior year, and an upcoming virtual webinar [9] Group 5: BioRestorative Therapies Inc. (BRTX) - Shares edged 4.6% higher in after-hours trading to $1.60, following a modest 2% gain during the regular session, with a closing price of $1.53 and trading volume of 415,798 shares [10] - The increase followed the announcement of a $1.085 million registered direct offering priced at $1.60 per share, with proceeds aimed at advancing clinical trials and other corporate purposes [11]

Financial Performance - The company reported a net loss of $3.93 million for the three months ended June 30, 2025, compared to a net loss of $3.01 million for the same period in 2024, representing an increase of approximately 30.7%[73] - Operating loss for the six months ended June 30, 2025, was $6.80 million, compared to $5.89 million for the same period in 2024, indicating an increase of approximately 15.4%[73] - An accumulated deficit of $94.0 million was reported at June 30, 2025, with a net loss of $6.8 million for the six months ended June 30, 2025[91] Research and Development - Research and development expenses for the three months ended June 30, 2025, were $2.45 million, up from $1.73 million in the same period in 2024, reflecting an increase of 41.5%[73] - The company is currently in a Phase 2 trial for NGC-Cap and is actively enrolling patients, aiming to obtain preliminary safety-efficacy data[65] - The company plans to use proceeds from financing for continued research and development of NGC-Cap and for working capital[68] Cash Flow and Financing - Cash used in operating activities for the six months ended June 30, 2025, was $5.00 million, compared to $5.39 million for the same period in 2024, showing a decrease of approximately 7.2%[85] - Net cash provided by financing activities included the sale of 15,340,972 shares of common stock and pre-funded warrants, generating significant capital for the company[88] - The company had cash and cash equivalents of $6.9 million as of June 30, 2025, which, along with $2.4 million received in August 2025, is expected to meet capital needs into Q1 2026[90] - The company plans to raise additional funds through public or private equity offerings, debt financings, and strategic alliances, but acknowledges potential dilution of existing stockholders' interests[93] General and Administrative Expenses - General and administrative expenses for the three months ended June 30, 2025, increased to $1.50 million from $1.35 million in the same period in 2024, a rise of approximately 11.1%[81] Contractual Obligations and Off-Balance Sheet Arrangements - No significant changes to contractual obligations were reported since the last Annual Report[94] - As of June 30, 2025, there were no off-balance sheet arrangements[95] Accounting Pronouncements - The company has not identified any material impact from recently issued accounting pronouncements on its financial position[99]

Core Insights - Processa Pharmaceuticals, Inc. has secured a strategic investment and is exploring corporate cryptocurrency treasury strategies to enhance financial flexibility and long-term value creation [1][2][4] Group 1: Strategic Financial Initiatives - The company believes that engaging with emerging financial technologies, including select cryptocurrencies, may diversify its capital base and enhance financial flexibility [2][3] - Processa is committed to compliance with regulatory standards while recognizing the potential of blockchain-based assets to fund clinical development programs, thereby reducing dilution for existing shareholders [3][4] Group 2: Corporate Development and Partnerships - The company is focused on long-term value creation, transparency, and responsible stewardship of investor capital, as stated by CEO George Ng [4] - Processa has engaged LifeSci Capital, LLC as an advisor for implementing its cryptocurrency treasury strategy [4] Group 3: Company Overview - Processa Pharmaceuticals is a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies aimed at improving safety and efficacy for cancer patients [5] - The company's strategy involves modifying existing FDA-approved oncology therapies to enhance their effectiveness while maintaining their cancer-killing mechanisms [5]

Core Insights - Processa Pharmaceuticals, Inc. has secured a strategic investment and is exploring corporate cryptocurrency treasury strategies to enhance financial flexibility and long-term value creation [1][2][4] Group 1: Strategic Financial Initiatives - The company believes that engaging with emerging financial technologies, including select cryptocurrencies, may diversify its capital base and enhance financial flexibility [2][3] - Processa is committed to compliance with regulatory standards while recognizing the potential of blockchain-based assets to fund clinical development programs, thereby reducing dilution for existing shareholders [3][4] - The company is focused on long-term value creation, transparency, and responsible stewardship of investor capital [4] Group 2: Company Overview - Processa Pharmaceuticals is a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies aimed at improving safety and efficacy for cancer patients [5] - The NGC drugs are modifications of existing FDA-approved oncology therapies, designed to alter metabolism and distribution while maintaining cancer cell-killing mechanisms [5] - In addition to oncology programs, Processa is pursuing strategic partnerships for non-oncology assets to unlock additional value [5]

Summary of Processa Pharmaceuticals (PCSA) Update / Briefing July 09, 2025 Company Overview - **Company**: Processa Pharmaceuticals - **Ticker**: PCSA - **Industry**: Pharmaceuticals, specifically oncology drug development Core Points and Arguments 1. **Derisked Approach**: Processa Pharmaceuticals adopts a derisked approach to drug development, focusing on improving existing cancer therapies rather than creating entirely new drugs. This strategy aims to enhance efficacy and safety of current treatments [15][29][40] 2. **Regulatory Science**: The company has a proprietary regulatory science approach that has led to 30 regulatory approvals, aligning with FDA's new project optimist requirements for oncology drugs [15][16][30] 3. **Pipeline Overview**: - **PCS 6422**: A combination therapy with capecitabine, showing a 67% response rate in a phase 1b trial, significantly higher than the 20-40% response rate for capecitabine alone. The drug also demonstrated better safety, with only 6% of patients experiencing hand and foot syndrome compared to 50% for capecitabine alone [18][19][34] - **PCS 11T**: An altered version of SN-38, aiming to reduce off-target effects and improve safety by preferentially drawing the drug into tumor cells. The goal is to potentially remove black box warnings associated with existing drugs [22][35] - **PCS 12852**: Recently partnered with Intact Therapeutics, with a deal valued at approximately $454 million, including milestone payments and royalties [24][25] - **PCS 499**: Pivoting back to renal and nephropathy space, with plans for a phase 3 adaptive study, potentially being the only drug in its category without a black box warning [26][27][45] Market Position and Competitive Advantage 1. **High Unmet Need**: Despite advancements in oncology, cancer remains the second leading cause of death, indicating a significant market opportunity for better therapies [16] 2. **Competitive Differentiation**: Processa's derisked approach allows it to focus on enhancing existing therapies, which is seen as a lower bar compared to developing new drugs from scratch. This strategy is supported by a seasoned management team with extensive experience in public companies and regulatory approvals [30][40][48] 3. **Strategic Partnerships**: The company is actively seeking partnerships to accelerate drug development, particularly for PCS 499 and oncology assets, with ongoing discussions with major players in the renal space [44][46] Upcoming Catalysts 1. **Phase 2 Preliminary Analysis**: Expected results for PCS 6422 in the second half of the year, which could provide significant data for future partnerships [31][49] 2. **FDA Interactions**: Ongoing engagement with the FDA regarding study protocols and potential approvals, particularly for PCS 499 and the phase 2 study for PCS 6422 [41][43] Additional Important Information 1. **Market Potential**: The ability to make capecitabine safer and more effective could expand the patient population, particularly among those who are currently not prescribed the drug due to its side effects [34][38] 2. **Investor Sentiment**: The CEO expressed confidence in the company's undervaluation and the potential for significant returns due to the derisked approach and multiple drug candidates in the pipeline [47][48] This summary encapsulates the key points from the Processa Pharmaceuticals update, highlighting the company's strategic focus, pipeline developments, and market positioning within the oncology sector.

Core Insights - Processa Pharmaceuticals is focusing on oncology assets with strong differentiation and commercial opportunity to enhance shareholder value [4][9] - The company is actively enrolling patients in a Phase 2 clinical trial for its lead oncology asset, PCS6422, targeting metastatic breast cancer, with initial data expected in the second half of 2025 [2][7] - Processa has signed a binding term sheet with Intact Therapeutics for PCS12852, which could yield up to $454 million in milestone payments and a 12% royalty on future sales [7] Company Updates - The company is streamlining its development pipeline and optimizing capital allocation to focus on programs with the highest potential for clinical success [2][4] - A new adaptive pivotal Phase III study for PCS499 is being designed, following preliminary positive results in kidney disease [7] - Processa has terminated the license agreement for PCS3117 due to high costs and time requirements, returning rights to the original licensor [7] Financial and Strategic Developments - Processa has strengthened its balance sheet with a $7 million capital infusion [6] - The company is establishing a dedicated subsidiary for PCS499 to enhance strategic flexibility in capital raising and partnership exploration [7] - An investor webinar is scheduled for July 9, 2025, to discuss the company's strategic pipeline realignment and milestones [5]

Core Viewpoint - Processa Pharmaceuticals, Inc. has announced a public offering of 28 million shares of common stock at a price of $0.25 per share, aiming to raise approximately $7 million for clinical trials and general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes 28 million shares of common stock or pre-funded warrants, along with common warrants to purchase an additional 28 million shares at an exercise price of $0.25 per share [1]. - The offering is expected to close around June 18, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to continue the Phase 2 clinical trial for NCG-Cap, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Processa Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing Next Generation Cancer (NGC) therapies that enhance safety and efficacy [5]. - The company's NGC drugs are modifications of existing FDA-approved oncology therapies, aiming to improve the metabolism and distribution of these drugs while retaining their cancer-killing mechanisms [5].