Key Takeaways PCSA surged 122.3% after a phase II update from its NGC-Cap breast cancer study.Processa Pharmaceuticals reported higher exposure to cancer-killing metabolites versus Xeloda monotherapy.PCSA said tolerability was comparable, with far lower FBAL exposure and only mild side effects.Shares of Processa Pharmaceuticals (PCSA) surged 122.3% on Wednesday after the company provided an encouraging clinical update on its ongoing mid-stage study evaluating its investigational candidate NGC-Cap in patient ...

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock is skyrocketing on Wednesday, with a session volume of 2.73 million compared to the average volume of 389.09 thousand, as per data from Benzinga Pro.Processa Pharmaceuticals on Wednesday provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases expo ...

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine Company on track to conduct formal interim analysis in early 2026 VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combinat ...

Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Financial Performance - Processa Pharmaceuticals reported a net loss of $3,436,573 for the three months ended September 30, 2025, compared to a net loss of $3,384,703 for the same period in 2024, reflecting an increase of $51,870[78]. - Operating loss for the nine months ended September 30, 2025, was $10,286,616, compared to $9,316,475 for the same period in 2024[78]. - The company generated a net loss of $10.2 million during the nine months ended September 30, 2025, with an accumulated deficit of $97.4 million[98]. - Other income for the three months ended September 30, 2025 was approximately $52,000, compared to $40,000 for the same period in 2024, and for the nine months ended September 30, 2025, it was approximately $74,000 versus $195,000 in 2024[88]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $8,484,617, a decrease from $8,997,321 in 2024, attributed to timing of prepaid asset payments[92]. - The company has incurred losses since inception and does not expect positive cash flow from operations in the foreseeable future[98]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1,661,646, a decrease of $625,879 from $2,287,525 in the same period in 2024[78]. - The NGC-Cap Phase 2 trial for advanced or metastatic breast cancer is actively enrolling patients, with preliminary safety-efficacy data expected to inform protocol modifications[69]. - PCS12852, a drug for gastroparesis, is Phase 2B ready, with a binding term sheet signed with Intact Therapeutics for potential licensing, including a $2.5 million payment upon execution[73]. - The company is evaluating the clinical safety and efficacy of PCS499 for primary glomerular diseases, with plans to meet with the FDA in Q4 2025 to discuss the Phase 3 study design[70]. - The company has a pipeline of Next Generation Cancer therapies, with NGC-Cap currently in Phase 2 and NGC-Iri in preclinical development[65]. Expenses and Cash Management - General and administrative expenses for the three months ended September 30, 2025 increased by approximately $681,000 to $1.8 million from $1.1 million for the same period in 2024, primarily due to salary increases and professional fees[86]. - For the nine months ended September 30, 2025, general and administrative expenses rose by approximately $831,000 to $4.6 million from $3.8 million in 2024, driven by salary increases and stock-based compensation[87]. - As of September 30, 2025, the company had cash and cash equivalents totaling $6.3 million, which, along with subsequent proceeds of $945,000, is expected to satisfy capital needs into the first quarter of 2026[97]. Capital Raising and Financing - The company raised net proceeds of $10.6 million through public offerings during the nine months ended September 30, 2025, selling 15,340,972 shares of common stock[71]. - During the nine months ended September 30, 2025, the company raised net proceeds of $12.9 million from selling shares and warrants in various offerings[95]. - The company plans to raise additional funds through equity offerings, debt financings, and strategic alliances, but may face challenges if adequate financing is not obtained[100]. - As of September 30, 2025, the company did not have any off-balance sheet arrangements[103]. Strategic Initiatives - Processa Pharmaceuticals is exploring options for its non-oncology drugs, which may include out-licensing or partnership opportunities[66]. - As of November 3, 2025, Processa Pharmaceuticals owned $850,000 in Digital Assets and plans to engage in capital raising transactions to purchase more Digital Assets[68].

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].

Core Insights - Processa Pharmaceuticals Inc. (NASDAQ:PCSA) shares experienced a significant increase of 37.5% to $0.50 in after-hours trading, following a 29.03% gain during the regular session, closing at $0.36 [1] - Despite the recent surge, the company has faced challenges, with shares down 71.43% over the past year and 59.09% year to date, although there has been a 50% gain over the last six months [2] Clinical Development - Processa Pharmaceuticals is conducting a Phase 2 clinical trial for next-generation capecitabine (NGC-Cap) as a treatment for advanced or metastatic breast cancer, with the first patient treated in October 2024 [3] - The trial is a global, multicenter study comparing two doses of NGC-Cap with the FDA-approved drug capecitabine, involving 60 to 90 patients [3] - Interim analysis results are expected to be announced in mid-2025, as stated by David Young, President of Research and Development [4] Market Context - Breast cancer represents a significant market opportunity, with over 2 million cases diagnosed globally in 2022 and a five-year survival rate of approximately 30% for metastatic cases [6] - For the second quarter, Processa reported a loss of $0.25 per share, which was wider than the expected loss of $0.23, and the company generated no revenue during that quarter [6] - The third-quarter earnings report is scheduled for October 29 [6] Stock Performance - Over the past year, PCSA shares have traded between $0.15 and $1.50, with an average daily trading volume of 3.95 million shares and a market capitalization of $18.06 million [7] - Current trends indicate that PCSA is experiencing long-term consolidation according to Benzinga's Edge Stock Rankings [7]

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]