Ernexa Therapeutics Inc.

Ernexa Therapeutics Inc. announced the resignation of Sandra Gurrola, its Senior Vice President of Finance, effective July 3, 2026. The company stated that her departure was not due to any disagreement regarding its operations, policies, or practices. Ms. Gurrola has agreed to provide part-time transition assistance until the filing of the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. Ernexa Therapeutics has begun a search for a successor and plans to utilize external support for finance, accounting, and reporting matters in the interim.

Ernexa Therapeutics has launched its new "CEO Corner" platform, featuring President and CEO Sanjeev Luther. This platform is designed to offer stakeholders deeper insights into the company's developments, scientific progress, strategic priorities, and its mission to advance innovative cell therapies. The initiative aims to enhance communication beyond traditional announcements, focusing on improving accessibility and affordability of treatments for advanced cancer and autoimmune diseases. The inaugural video highlights Ernexa's mission, scientific strategy, and commitment to differentiated cell therapies.

Ernexa Therapeutics announced significant progress for its lead oncology candidate, ERNA-101, with manufacturing process development completed and GMP production underway. The company plans to submit an Investigational New Drug (IND) application in Q3 2026 and initiate a first-in-human Phase 1 clinical study in Q4 2026 for platinum-resistant ovarian cancer. Preclinical data demonstrated compelling anti-tumor activity, especially in combination with PD-1 blockade. Ernexa also stated it has sufficient resources from a recent $10.5 million financing to support its near-term development strategy and anticipated milestones.

Ernexa Therapeutics announced its participation in a Virtual Investor KOL Connect segment featuring Dr. Ira S. Winer, a Scientific Advisory Board Member. Dr. Winer provided insights into the significant unmet needs in ovarian cancer, limitations of current treatments, and the growing focus on overcoming immunologically "cold" tumors. The discussion also highlighted the potential of scalable, off-the-shelf engineered cell therapies in future oncology treatment paradigms. Additionally, Dr. Winer detailed Ernexa’s ERNA-101 program, emphasizing its dual mechanism approach for tumor microenvironment remodeling and immune activation, and the advantages of the company's engineered allogeneic induced mesenchymal stem cell (iMSC) platform for improved accessibility and manufacturing scalability.

Ernexa Therapeutics announced significant progress for its lead therapeutic candidate, ERNA-101, positioning it for an Investigational New Drug (IND) submission in the third quarter of 2026. The company successfully completed process development activities and transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. This advancement, along with ongoing technology transfer, marks a critical step towards initiating its first-in-human clinical study and transforming Ernexa into a clinical-stage biotechnology company.

Ernexa Therapeutics announced a Virtual Investor KOL Connect segment featuring Dr. Elena Ratner, a Yale Professor and Ernexa Board member. Dr. Ratner discussed the significant unmet need in ovarian cancer and the limitations of current therapies. The segment highlighted Ernexa's lead product candidate, ERNA-101, and its preclinical data showing complete tumor elimination and 100% long-term survival in ovarian cancer models when combined with PD-1 blockade. The discussion also covered the advantages of Ernexa's scalable, off-the-shelf allogeneic iMSC platform.

Ernexa Therapeutics Inc. announced its 2026 annual meeting of stockholders will be held virtually on July 1, 2026, at 11:00 a.m. Eastern Time. Shareholders of record as of May 6, 2026, will vote on the election of five director nominees, the ratification of Haskell & White LLP as the independent registered public accounting firm for 2026, and the adoption of the 2026 Omnibus Equity Incentive Plan. The company's board of directors recommends voting "FOR" all proposals.

Ernexa Therapeutics Inc. reported a net loss of $5.5 million for Q1 2026, a decrease from $8.2 million in Q1 2025, which included a $2.0 million goodwill impairment charge. The company significantly improved its cash position by raising approximately $9.5 million in net proceeds from a public offering in February 2026. As of March 31, 2026, cash stood at $9.2 million, and the company also established an At-the-Market (ATM) program for up to $9.2 million to support future capital needs.

Ernexa Therapeutics announced new preclinical data for its lead cell therapy candidate, ERNA-101, demonstrating complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models when combined with PD-1 blockade. These results significantly exceeded outcomes observed with either therapy alone, indicating potential curative activity and ERNA-101's ability to remodel the tumor microenvironment. The company plans to advance ERNA-101 towards a first-in-human clinical trial for advanced ovarian cancer, with potential to broaden indications to other solid tumors.

Ernexa Therapeutics Inc. implemented a 1-for-25 reverse stock split, effective May 4, 2026. The company filed a certificate of amendment to its Restated Certificate of Incorporation on May 1, 2026, to enact this change. Following the split, the common stock commenced trading on a split-adjusted basis on Nasdaq under a new CUSIP number.