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, 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: 001-11460 Ernexa Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 31-110342 ...

Core Viewpoint - Ernexa Therapeutics has regained compliance with Nasdaq for continued listing, allowing its stock to continue trading on the Nasdaq Stock Market [1][2]. Company Overview - Ernexa Therapeutics is focused on developing innovative stem cell therapies for advanced cancer and autoimmune diseases, utilizing engineered induced pluripotent stem cells (iPSCs) to create allogeneic synthetic induced mesenchymal stem cells (iMSCs) [4]. - The company’s lead product, ERNA-101, aims to activate and regulate the immune system to target cancer cells, while ERNA-102 is designed to address inflammation in autoimmune diseases [5]. Future Plans - The company is on track to initiate its first clinical trial in early 2026, emphasizing its commitment to advancing its programs for patients with ovarian cancer and autoimmune diseases [3].

Core Insights - Ernexa Therapeutics is transitioning from research to clinical-stage development, focusing on innovative cell therapies for advanced cancer and autoimmune diseases [1][3] - The company has expanded its Scientific Advisory Board to include distinguished medical leaders to guide its clinical programs [2][3] Company Developments - Ernexa has strengthened its financial position, which supports its strategy to accelerate lead programs toward clinical trials [1] - The newly formed advisory board will assist in trial design, biomarker development, and regulatory engagement as the company prepares for IND-enabling studies [3][6] Advisory Board Composition - Dr. Amir Anthony Jazaeri, an expert in gynecologic oncology, will guide the ovarian cancer program [2][4] - Dr. Anna Helena Jonsson, a specialist in autoimmune diseases, will lead the translational strategy for the autoimmune pipeline [2][5] Product Focus - The lead product, ERNA-101, aims to activate and regulate the immune system to target cancer cells, with an initial focus on ovarian cancer [8] - ERNA-102 is designed to address inflammation in autoimmune diseases [8] Scientific Approach - Ernexa's core technology involves engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs), providing scalable treatment options [7]

Core Points - Ernexa Therapeutics has completed a second closing under a securities purchase agreement, raising total gross proceeds to $7.1 million to support working capital initiatives [1][3] - The company issued 3,181,145 shares of common stock and 622,134 prefunded warrants in the second closing, generating approximately $6.0 million in gross proceeds [2] - The initial closing occurred on April 2, 2025, where the company raised approximately $1.1 million by issuing 662,269 shares of common stock and 33,983 prefunded warrants [2] - The financing was approved by stockholders at the 2025 Annual Meeting held on June 2, 2025, as required by Nasdaq listing rules [3] Financial Details - The total gross proceeds from the financing amount to $7.1 million, which includes the initial and second closings [1] - A remaining subscription amount of $190,248 for 121,255 shares of common stock is still pending [2] Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) [5] - The lead product, ERNA-101, aims to activate the immune system to target cancer cells, while ERNA-102 is designed to address inflammation in autoimmune diseases [6] - The company's initial focus is on developing ERNA-101 for ovarian cancer treatment [6] Warrant Details - The prefunded warrants have a nominal exercise price of $0.075 per share and are subject to ownership limitations of 4.99% or 9.99% of the company's outstanding common stock [4]

Core Viewpoint - Ernexa Therapeutics announced a reverse stock split at a ratio of 1-for-15 to comply with Nasdaq's minimum bid price requirement for continued listing [1][2][7] Group 1: Reverse Stock Split Details - The reverse stock split will take effect on June 12, 2025, at 12:01 a.m. Eastern Time, with trading on a split-adjusted basis commencing the same day [1] - Every 15 shares of Common Stock will be reclassified into one new share, with no modification to the rights or preferences of the shares [2] - The company had 110,418,022 shares outstanding prior to the split, which will reduce to approximately 7,361,201 shares post-split [4] Group 2: Shareholder Impact - No fractional shares will be issued; stockholders will receive one whole share instead of fractional shares [3] - Stockholders holding pre-split certificates will receive instructions from Computershare on how to surrender their certificates [5] Group 3: Company Background and Strategy - Ernexa Therapeutics focuses on developing innovative stem cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells [8] - The company’s lead product, ERNA-101, aims to activate the immune system against cancer cells, with an initial focus on ovarian cancer [9][10] - The reverse stock split is part of a broader strategy to strengthen the company's financial foundation and maintain access to capital markets for advancing clinical programs [7]

Core Insights - Ernexa Therapeutics has developed a novel iMSC-based immunotherapy platform that successfully converts "cold" ovarian tumors into "hot" tumors, potentially enhancing immune response and improving patient outcomes [1][2][4] Company Overview - Ernexa Therapeutics (Nasdaq: ERNA) focuses on innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs) [5][6] - The company is currently developing two preclinical cell therapy products: ERNA-101, aimed at activating the immune system against cancer, and ERNA-102, targeting inflammation in autoimmune diseases [6] Research Findings - The study demonstrated that iMSCs engineered to secrete cytokines IL-7 and IL-15 can migrate into the tumor microenvironment, leading to significant immune activation, including T cell and macrophage infiltration [2][3] - In a syngeneic ovarian cancer mouse model, treatment with IL-7/IL-15-secreting iMSCs resulted in a significant reduction in tumor burden and extended survival [3] Upcoming Presentation - Ernexa will present its findings at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025, with a poster titled "Engineering iPSC-derived mesenchymal stem cells (iMSCs) to secrete IL-7/IL-15 for modulation of the tumor microenvironment in a 'cold' ovarian tumor model" [4]

Core Insights - Ernexa Therapeutics has established a new subsidiary, ErnexaTX2, to support the preclinical development of its lead program, ERNA-101, for ovarian cancer and to prepare for clinical activities anticipated in 2026 [1][3]. Company Developments - The formation of ErnexaTX2 demonstrates the company's commitment to the Texas ecosystem and its readiness for clinical manufacturing, regulatory interactions, and site activation in the future [2]. - Ernexa is advancing its infrastructure in anticipation of Investigational New Drug (IND)-enabling activities, with ERNA-101 on track for IND-enabling studies in 2025 and first-in-human studies targeted for 2026 [3]. Product Information - ERNA-101 is designed to activate and regulate the immune system's response to recognize and attack cancer cells, while ERNA-102 targets inflammation to treat autoimmune diseases [5]. - The company's core technology involves engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs), providing a scalable, off-the-shelf treatment option [4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q For the transition period from _________ to _____________ Commission file number: 001-11460 (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, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Ernexa Therapeutics Inc. (Exact name of registrant as specified in its charter) 1035 Cambridge St ...

Core Insights - Ernexa Therapeutics presented new data on engineered cell therapies for ovarian cancer at the AACR Annual Meeting 2025, highlighting the potential of these therapies to enhance immune response and shrink tumors [1][4]. Company Overview - Ernexa Therapeutics (Nasdaq: ERNA) focuses on developing innovative cell therapies for advanced solid tumors and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) transformed into induced mesenchymal stem cells (iMSCs) [5][6]. - The company’s lead product, ERNA-101, aims to activate and regulate the immune system's response against cancer cells, specifically targeting ovarian cancer [6]. Research Findings - The study demonstrated that iMSCs significantly slowed tumor growth and improved survival rates in mice with ovarian cancer, increasing the presence of immune cells such as T cells, natural killer (NK) cells, and macrophages [3]. - iMSCs were shown to enhance T cell growth and multiplication, even in drug-resistant cancer cases, outperforming traditional MSCs in these aspects [3]. Future Implications - The findings suggest that ERNA-101 could represent a more effective, accessible, and scalable treatment option for cancer patients, reinforcing Ernexa's commitment to advancing cancer therapies [4].

Core Insights - Ernexa Therapeutics is advancing its strategic focus on innovative cell therapies for cancer and autoimmune diseases, particularly ovarian cancer [1][2][3] - The company has entered into a securities purchase agreement for a private placement of approximately 69.3 million shares at a price of $0.1046 per share, totaling around $7.25 million, pending stockholder approval [1][2] - The first closing of this transaction occurred on April 2, 2025, raising approximately $1.1 million from the issuance of about 10.4 million shares [2] Company Overview - Ernexa Therapeutics specializes in developing cell therapies targeting advanced solid tumors and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create allogeneic synthetic mesenchymal stem cells (iMSCs) [4] - The company is currently focused on two preclinical cell therapy products: ERNA-101, aimed at treating ovarian cancer, and ERNA-102, designed to address inflammation in autoimmune diseases [5] Recent Developments - The recent fundraising follows a previous private investment in public equity (PIPE) round in 2024, which secured $5 million in financing [3] - Ernexa has undergone a rebranding to reflect its new strategic direction, emphasizing its commitment to advancing therapeutic innovation [2][3]