Core Insights - Ernexa Therapeutics announced promising preclinical results for its lead cell therapy candidate, ERNA-101, showing significant survival benefits and immune activation in ovarian cancer models [1][5] - The proprietary platform utilizes induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs), which can effectively reprogram immunosuppressive tumor microenvironments into immune-active states [2][4] Company Overview - Ernexa Therapeutics is focused on developing innovative cell therapies for advanced cancer and autoimmune diseases, leveraging a scalable, off-the-shelf approach that does not require patient-specific cell harvesting [7][6] - The company’s lead product, ERNA-101, aims to enhance the immune system's ability to recognize and attack cancer cells, with a specific initial focus on ovarian cancer [8][9] Research Findings - The preclinical study demonstrated that iMSCs engineered to secrete interleukin-7 (IL-7) and interleukin-15 (IL-15) produced cytokine levels approximately 20-fold higher than those reported in engineered T-cell approaches, leading to robust T-cell expansion and activation [4][5] - In an ovarian cancer model, the administration of IL-7/IL-15-secreting iMSCs resulted in significant immune cell infiltration, macrophage polarization towards a pro-inflammatory phenotype, and prolonged survival, indicating a shift from an immune-excluded to a highly inflamed tumor microenvironment [5][6] Future Directions - The company plans to advance ERNA-101 through additional preclinical testing, with first-in-human trials anticipated for the following year [6][4] - Ernexa Therapeutics views the ability to manufacture clonal, gene-modified cells at scale as a competitive advantage in the clinical development of its therapies [4]

CAMBRIDGE, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that data from its novel cell therapy platform will be shared in an oral presentation at the 67th ASH Annual Meeting, being held December 6-9, 2025 in Orlando, FL. “Being selected to give an oral presentation at ASH is a tremendous honor and a major milestone,” said Sanjeev Luther, President ...

CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the appointment of Dr. Ira S. Winer, M.D., Ph.D., FACOG, to its Scientific and Medical Advisory Board. Dr. Winer is a nationally recognized gynecologic oncologist and translational scientist. His expertise in women’s oncology, immunotherapy, and early-phase clinical development further streng ...

Core Insights - Ernexa Therapeutics is set to present at Cell 2025, focusing on innovations in cell therapies for advanced cancer and autoimmune diseases [1][3] - The presentations will emphasize the importance of smart trial design and early regulatory engagement to accelerate clinical progress in cell therapy development [1][2] Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) specializes in developing innovative cell therapies, particularly through engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) [4] - The company’s lead product, ERNA-101, aims to activate the immune system to target cancer cells, with a specific focus on ovarian cancer treatment [5] Event Details - The Cell 2025 event will take place on November 11-12, 2025, in London, UK, and is a key gathering for professionals in bioprocessing and advanced therapies [3] - Sanjeev Luther, President and CEO of Ernexa, will participate in a panel discussion addressing funding, innovation, and regulatory strategies for advancing their iMSC platform [2]

Core Insights - Ernexa Therapeutics reported a significant reduction in operating losses, with a 44% decline year-over-year, indicating effective operational execution and financial discipline [1][11] - The company is advancing its lead program, ERNA-101, towards a first-in-human Phase 1 study in platinum-resistant ovarian cancer, expected to commence in the second half of 2026 [1][6] - Ernexa has established a partnership with Cellipont Bioservices to enhance the development of ERNA-101, alongside reporting substantial year-over-year financial performance improvements [3][4] Financial Performance - The operating loss for the three months ended September 30, 2025, decreased by $0.3 million, or 12%, from $2.3 million in the same period of 2024 to $2.0 million [11] - For the nine months ended September 30, 2025, the operating loss decreased by $5.8 million, or 44%, from $13.0 million in 2024 to $7.2 million [11] - General and administrative expenses saw a significant reduction, with a 72% decrease from $3.4 million to $1.0 million for the three-month period, primarily due to a decrease in rent and legal fees [11] Development Programs - Ernexa is utilizing synthetic, allogeneic induced mesenchymal stem cells (iMSCs) for scalable, off-the-shelf treatments, focusing on ovarian cancer and autoimmune diseases [4][8] - ERNA-101 is designed to secrete pro-inflammatory fusion cytokines and is currently in preclinical development for platinum-resistant ovarian cancer [5][9] - ERNA-201 targets inflammation and is in preclinical development for rheumatoid arthritis and other inflammatory diseases [5][9] Strategic Collaborations - The partnership with Cellipont Bioservices is a strategic move to advance ERNA-101 towards clinical trials [3][4] - A sponsored research agreement with MD Anderson Cancer Center aims to leverage MSCs' tumor-homing ability to enhance anti-tumor activity while minimizing systemic toxicity [6]

Revenue and Loss - The company reported no revenue for the three and nine months ended September 30, 2025, compared to $0.487 million and $0.581 million for the same periods in 2024, respectively[132]. - The company experienced a loss from operations of $1.993 million for the three months ended September 30, 2025, compared to a loss of $2.259 million in 2024, reflecting an improvement of $266,000[132]. - The net loss for the three months ended September 30, 2025, was $1.240 million, a decrease of $25.364 million compared to a net loss of $26.604 million in 2024[132]. - A gain on extinguishment of debt of approximately $0.7 million was recognized for the three and nine months ended September 30, 2025, compared to a loss of $22.4 million in the same periods of 2024[142][143]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1.035 million, a slight increase of $34, compared to $1.001 million in 2024[135]. - Total research and development expenses for the nine months ended September 30, 2025, were $3.480 million, an increase of $34 from $3.446 million in 2024[136]. - Research and development expenses increased due to higher consulting services and costs associated with ERNA-101 and ERNA-201 studies, offset by reduced license fees and payroll-related costs[137]. - The company is focused on developing its lead product candidate ERNA-101 for platinum-resistant ovarian cancer, with IND submission expected by 2026[120]. - The company is also investigating ERNA-201 for inflammatory/auto-immune disorders, aiming to enhance anti-inflammatory effects[121]. General and Administrative Expenses - General and administrative expenses decreased significantly to $958,000 for the three months ended September 30, 2025, down from $3.381 million in 2024, a reduction of $2.423 million[132]. - General and administrative expenses for the three months ended September 30, 2025 decreased by approximately $2.4 million to $958,000 from $3.4 million in the same period of 2024, primarily due to reduced rent, professional fees, and stock-based compensation[138]. - For the nine months ended September 30, 2025, general and administrative expenses decreased by $7.8 million to $3.7 million from $11.6 million in the same period of 2024, attributed to the termination of a sublease and reductions in professional fees and payroll-related expenses[139]. Cash Flow and Financing - As of September 30, 2025, the company had cash of approximately $3.0 million and an accumulated deficit of approximately $244.1 million, with a net loss of $1.2 million for the three months and $12.6 million for the nine months ended September 30, 2025[153]. - Cash used in operating activities for the nine months ended September 30, 2025 was $5.9 million, a decrease of $6.4 million compared to $12.3 million in the same period of 2024[159][160]. - The company raised $7.2 million in gross proceeds from the sale of shares and prefunded warrants during the nine months ended September 30, 2025[155]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $2.3 million from promissory notes and $4.9 million from the 2025 SPA, net of $2.3 million receivable from a related party[162]. - For the nine months ended September 30, 2024, net cash provided by financing activities included $5.3 million from convertible notes issuance and bridge note financing[162]. Accounting and Regulatory Matters - There were no significant changes in critical accounting estimates during the three and nine months ended September 30, 2025, compared to the previous year[164]. - The company currently has no off-balance sheet arrangements as defined under SEC rules[163]. - As a smaller reporting company, the company is not required to provide additional market risk disclosures[166]. - The company expects to incur state income tax liabilities in 2025 and has established a full valuation allowance for all deferred tax assets[151]. - The company does not have sufficient capital to fund operations for the next 12 months and may need to reevaluate operations or seek additional capital[156][158]. Other Agreements - The company has entered into an Assignment Agreement with Factor Bioscience, which will pay the company 30% of amounts received from a customer sublicense[124]. - A gain on lease termination of approximately $1.6 million was recognized for the three and nine months ended September 30, 2024, with no similar transaction in 2025[140]. - For the nine months ended September 30, 2025, the company recognized $5.8 million related to a forward sales contract, with $5.3 million recognized at contract inception due to fair value exceeding proceeds[141].

Core Insights - Ernexa Therapeutics is advancing its lead cell therapy ERNA-101 for ovarian cancer through a partnership with Cellipont Bioservices [3] - The company specializes in innovative cell therapies targeting advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) [4] Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) focuses on developing novel cell therapies for advanced cancer and autoimmune diseases [4] - The company's technology involves engineering iPSCs into induced mesenchymal stem cells (iMSCs), providing scalable treatment solutions without the need for patient-specific cell harvesting [4] Product Details - ERNA-101 is designed to activate and regulate the immune system's response to recognize and attack cancer cells [5] - ERNA-201 targets inflammation to treat autoimmune diseases, with the initial focus on developing ERNA-101 for ovarian cancer [5]

Group 1: Stock Price Movements - Globalink Investment Inc. experienced a significant surge, with its stock price jumping to $0.09, marking a 581.82% increase, driven by heightened investor interest possibly due to speculative activities or potential business combination news [1][6] - Cambium Networks Corporation saw its stock price rise to $2.66, a 331.65% increase, attributed to the integration of its Cambium ONE Network solution with Starlink satellite Internet services, enhancing its growth prospects [2][6] - Purple Biotech Ltd. witnessed its stock price increase to $0.93, up by 59.74%, driven by promising updates on its clinical trials and strategic partnerships, particularly regarding its tri-specific antibody IM1240 [3][6] - Ernexa Therapeutics Inc. saw its price increase to $1.97, a 57.85% rise, influenced by investor optimism towards its innovative therapies and a partnership with Cellipont Bioservices for clinical trials [4][6] - VSee Health, Inc. experienced a 49.52% increase in its stock price to $0.17, reflecting growing investor interest in the telehealth sector amid ongoing healthcare trends [5] Group 2: Market Trends and Investor Sentiment - The stock movements underscore the dynamic nature of the market, where company-specific developments, sector trends, and broader economic factors significantly impact stock prices [5] - Investors and analysts closely monitor such changes to gauge market sentiment and identify potential investment opportunities [5]

Core Insights - Cellipont Bioservices has entered into a collaboration with Ernexa Therapeutics to advance ERNA-101, a cell therapy for ovarian cancer, into clinical manufacturing and trials [1][2][3] Company Overview - Cellipont Bioservices is a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell therapies, offering comprehensive solutions from process development to large-scale commercial manufacturing [4] - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs) [5][6] Technology and Product Development - ERNA-101 is designed to activate and regulate the immune system's response to cancer cells, with the potential to convert "cold" tumors into "hot" tumors, enhancing immune cell infiltration and suppressing tumor growth [3][6] - The collaboration will support the current Good Manufacturing Practice (cGMP) development and scale-up of the ERNA-101 manufacturing process in preparation for clinical trials [3]

Core Insights - Ernexa Therapeutics is set to present at the Cell & Gene Meeting on the Mesa, highlighting its advancements in cell therapies for cancer and autoimmune diseases [1][2] - The company aims to showcase its scalable iMSC therapies, particularly focusing on ERNA-101 for ovarian cancer and ERNA-201 for autoimmune diseases [3][6] Company Overview - Ernexa Therapeutics specializes in innovative cell therapies targeting advanced cancer and autoimmune diseases, utilizing proprietary synthetic, allogeneic induced mesenchymal stem cell (iMSC) technology [6] - The lead product, ERNA-101, is designed to stimulate the immune system against cancer cells, while ERNA-201 targets inflammation in autoimmune diseases [7] Upcoming Presentation Details - The presentation will take place on October 7, 2025, at 2:45 p.m. in Phoenix, Arizona, and will also be available via virtual livestream [8] - Ernexa previously shared insights on iPSC developments at the Annual iPSC Drug Development Summit and presented new data on ERNA-101 at the AACR Special Conference [4] Industry Context - The Cell & Gene Meeting on the Mesa serves as a significant platform for discussing commercialization challenges in the cell and gene therapy sector, featuring expert panels and industry leaders [5]