Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ERNA Catalyst Timeline
Dated clinical, regulatory and corporate events for Ernexa Therapeutics Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Ernexa Therapeutics Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How ERNA actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-05-13 | ERNA-101 | Pre-clinical data readout | Pre-clinical |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IRX-2 Monoclonal antibodyCompletedNCT02609386 | Squamous Cell Carcinoma of the Oral Cavity | Phase 2 | COMPLETED | 105 | Feb 28, 2022 |
Clinical Trial Results
Readouts, endpoints and source filings for every ERNA program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ERNA-101 | cancer | 2026-09-30 | No ERNA-101-related adverse findings were observed at any dose level tested in a 50-day GLP toxicology study in tumor-bearing mice with an intact immune system.; No teratoma formation was observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase.; No significant ERNA-101 signal was detected in tumor-free animals or non-tumor tissues.Read More | Ernexa Therapeutics Reports Compelling ERNA-101 Safety Results Across Three Critical IND-Enabling Studies, Advancing Toward Planned Q4 2026 INDRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Cherington Charles10% Owner | Buy | 4,000,000 6,779,440 held | $0.50 | 02/10/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ERNA
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in ERNA for Q2 2026. | ||||
ERNA Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How ERNA ranks across every disease it competes in
ERNA News
Ernexa Therapeutics CEO Corner Highlights Appointment of Dr. Robert J. Spiegel as Company Sharpens Oncology Focus and Advances ERNA-101 Toward the Clinic
Ernexa Therapeutics has appointed Dr. Robert J. Spiegel to its Board, enhancing its oncology focus as it advances ERNA-101 towards clinical trials. The drug has demonstrated complete tumor clearance and 100% survival in preclinical studies. Ernexa aims for an IND submission in Q4 2026 and a first-in-human study in Q1 2027, targeting difficult-to-treat solid tumors.
Read more →Ernexa Therapeutics Reports Compelling ERNA-101 Safety Results Across Three Critical IND-Enabling Studies, Advancing Toward Planned Q4 2026 IND
Ernexa Therapeutics announced positive results from three IND-enabling safety studies of ERNA-101, its iMSC therapy for cancer. The studies showed no adverse findings in toxicology, no teratoma formation, and effective tumor-homing capabilities. These results support the safety and efficacy of ERNA-101 as the company prepares for an IND submission in Q4 2026.
Read more →Ernexa Therapeutics Selected for Emerging Track at 2026 Cell & Gene Meeting on the Mesa, Highlighting ERNA-101 and Focused Oncology Strategy
Ernexa Therapeutics has been selected for the Emerging Track at the 2026 Cell & Gene Meeting on the Mesa. CEO Sanjeev Luther will present the company's focused oncology strategy, particularly highlighting ERNA-101 for platinum-resistant ovarian cancer. The presentation will showcase the promising preclinical data supporting ERNA-101's efficacy and the innovative synthetic iMSC platform. The company is on track for an IND submission in 2026.
Read more →Ernexa Therapeutics Appoints Accomplished Biopharmaceutical Executive Robert J. Spiegel, M.D., FACP, to Board of Directors
Ernexa Therapeutics has appointed Dr. Robert J. Spiegel to its Board of Directors, enhancing its leadership as it advances ERNA-101 towards clinical development. Dr. Spiegel's extensive experience in oncology and regulatory affairs is expected to provide valuable insights as the company focuses on addressing unmet needs in ovarian cancer treatment. The appointment comes at a critical time for Ernexa as it prepares for clinical evaluation of its lead cell therapy candidate.
Read more →Ernexa Therapeutics Reports Positive Disease Modifying ERNA-201 Preclinical Data, Reinforcing iMSC Platform as Company Accelerates Oncology Strategy and ERNA-101 Toward First-in-Human Dosing
Ernexa Therapeutics reported positive preclinical results for ERNA-201, demonstrating its potential in treating inflammatory diseases. The findings support the versatility of the company's synthetic iMSC platform. Ernexa is prioritizing resources on ERNA-101, which is set for a first-in-human study in platinum-resistant ovarian cancer. The company aims to broaden its oncology strategy while preserving ERNA-201 for future development.
Read more →Ernexa Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference
Ernexa Therapeutics announced that its President and CEO, Sanjeev Luther, will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 16, 2026. The presentation will cover the company's oncology strategy and progress with its lead cell therapy candidate, ERNA-101. Ernexa is focused on developing innovative cell therapies for advanced cancers, particularly ovarian cancer.
Read more →Ernexa Therapeutics Participates in the Virtual Investor "Why Now" On-Demand Conference
Ernexa Therapeutics participated in the Virtual Investor "Why Now" on-demand conference, where CEO Sanjeev Luther discussed the company's investment thesis. He emphasized the significance of transitioning to a clinical-stage company and highlighted the promising preclinical results of their lead candidate, ERNA-101, aimed at treating ovarian cancer. The company is preparing for an IND submission and its first Phase 1 clinical study.
Read more →Ernexa Therapeutics Strengthens Board with Veteran Biotech Executive David Polinsky as Company Approaches Clinical Stage
Ernexa Therapeutics has appointed David Polinsky to its Board of Directors as the company approaches a pivotal stage in its development. With plans for an IND submission for ERNA-101 in Q3 2026 and a Phase 1 clinical study initiation in Q4 2026, the leadership team aims to strengthen its operational infrastructure. Polinsky's extensive experience in biotechnology and corporate governance is expected to guide Ernexa through its upcoming clinical milestones.
Read more →Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies
Ernexa Therapeutics' CEO Sanjeev Luther highlights the potential of ERNA-101 in transforming cancer treatment through combination therapies. The therapy aims to target immunologically 'cold' tumors, enhancing the effectiveness of existing immunotherapies. Encouraging preclinical results support its development, with plans for an IND submission in Q3 2026 and a Phase 1 study to follow.
Read more →Ernexa Therapeutics Receives Independent Validation of ERNA-101 with Complete Tumor Clearance and Durable Survival in Ovarian Cancer Models Ahead of Planned Clinical Entry
Ernexa Therapeutics announced successful independent validation of its lead therapy, ERNA-101, demonstrating complete tumor clearance and long-term survival in a preclinical study. The combination of ERNA-101 with anti-PD-1 therapy showed significant results, with plans for an IND submission in Q3 2026 and a Phase 1 trial expected in Q4 2026. This study strengthens the foundation for ERNA-101's clinical development.
Read more →Ernexa Therapeutics CEO Corner Highlights Differentiated ERNA-101 Platform as Company Advances Toward Planned First-in-Human Phase 1 Study in 2026
Ernexa Therapeutics is advancing its lead cell therapy candidate, ERNA-101, aimed at treating ovarian cancer. The company plans to submit an IND application in Q3 2026, with a first-in-human Phase 1 study expected to start in Q4 2026. CEO Sanjeev Luther highlighted the potential of ERNA-101 to convert immunologically 'cold' tumors into detectable targets for the immune system. Encouraging preclinical data supports the efficacy of ERNA-101 in tumor clearance and survival rates.
Read more →Ernexa Therapeutics Launches CEO Corner to Provide Deeper Insights into Company Progress, Scientific Strategy and Vision for Patients
Ernexa Therapeutics has launched its CEO Corner platform to provide insights into the company's mission and scientific strategy. The inaugural video features CEO Sanjeev Luther discussing the company's commitment to developing innovative cell therapies for advanced cancer and autoimmune diseases. The platform aims to enhance communication with stakeholders and emphasize the importance of accessibility and affordability in treatment.
Read more →Ernexa Therapeutics Positioned to Become a Clinical-Stage Biotechnology Company as ERNA-101 On Track for Planned Q3 2026 IND Submission and First-in-Human Study
Ernexa Therapeutics is advancing its lead oncology candidate, ERNA-101, with a planned IND submission in Q3 2026 and a first-in-human study expected in Q4 2026. The therapy aims to treat immunologically cold tumors, showing promising preclinical results. The company has completed key manufacturing and regulatory milestones, positioning itself for clinical-stage development.
Read more →Ernexa Therapeutics Highlights Ovarian Cancer Unmet Need, Hope for Patients and Potential Accessibility Advantages of ERNA-101 in Virtual Investor KOL Connect Segment Featuring Dr. Ira Winer
Ernexa Therapeutics highlighted the unmet needs in ovarian cancer during a Virtual Investor KOL Connect segment featuring Dr. Ira Winer. The discussion focused on the limitations of current treatments and the potential of ERNA-101, which aims to activate immune responses in the tumor microenvironment. The engineered cell therapy may offer scalable solutions that improve accessibility for patients facing difficult-to-treat cancers.
Read more →Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development
Ernexa Therapeutics has made significant strides in the development of its lead candidate, ERNA-101, by completing critical manufacturing milestones and transitioning to GMP manufacturing. The company is on track for an Investigational New Drug (IND) submission in Q3 2026, which will pave the way for its first-in-human clinical study. These advancements reflect Ernexa's commitment to addressing unmet medical needs in cancer and autoimmune diseases.
Read more →Ernexa Therapeutics Releases Virtual Investor KOL Connect Segment Featuring Dr. Elena Ratner Highlighting Ovarian Cancer Landscape and ERNA-101 Opportunity
Ernexa Therapeutics has released a Virtual Investor KOL Connect segment featuring Dr. Elena Ratner, who discusses the challenges in treating ovarian cancer and the potential of ERNA-101. The segment highlights the limitations of current therapies and elevates Ernexa's innovative approach with preclinical data showing successful tumor eradication. Dr. Ratner emphasizes the advantages of the company's engineered allogeneic iMSC platform, which aims to enhance accessibility and efficiency in treatment. This development underscores Ernexa's commitment to addressing significant unmet needs in the cancer treatment landscape.
Read more →Ernexa Therapeutics Releases Virtual Investor KOL Connect Segment Highlighting Ovarian Cancer Landscape and Lead Candidate ERNA-101
Ernexa Therapeutics has released a Virtual Investor KOL Connect segment featuring Dr. Robert Pierce, discussing the challenges in ovarian cancer treatment and the potential of their lead candidate, ERNA-101. The segment emphasizes the need for more effective therapies and outlines how ERNA-101 could enhance patient outcomes. Additionally, the company will participate in a Virtual Investor Closing Bell event on May 13, 2026, to discuss preclinical data for ERNA-101.
Read more →Ernexa Therapeutics Unveils Breakthrough Preclinical Results: ERNA-101 Achieves 100% Survival and Complete Tumor Elimination in Ovarian Cancer Models
Ernexa Therapeutics announced remarkable preclinical results for its lead cell therapy candidate, ERNA-101, which demonstrated complete tumor elimination and 100% long-term survival in ovarian cancer models. The therapy, in combination with PD-1 blockade, showed significant efficacy by converting the tumor microenvironment from immunosuppressive to immune-activated. With plans to advance ERNA-101 towards human trials, Ernexa aims to address the challenges posed by ovarian cancer treatments traditionally hindered by a non-responsive immune environment. The company intends to explore additional indications for ERNA-101 in other solid tumors as well.
Read more →Ernexa Therapeutics Announces 1-for-25 Reverse Stock Split
Ernexa Therapeutics has announced a 1-for-25 reverse stock split effective May 4, 2026, to comply with Nasdaq's minimum bid price requirement. This move aims to enhance the company's financial standing and visibility among investors. The split will adjust the number of shares outstanding while maintaining the rights of existing shares. The company is focused on advancing its clinical programs and strengthening its market position.
Read more →Ernexa Therapeutics Highlights Key Catalysts as Company Advances Toward First-in-Human Clinical Trials in 2026
Ernexa Therapeutics is advancing its lead product candidate, ERNA-101, toward first-in-human clinical trials anticipated to begin in Q4 2026. The company has demonstrated promising preclinical data showcasing its potential in treating platinum-resistant ovarian cancer. Key regulatory milestones, including an IND submission expected in Q3 2026, are set to support the company's transition from preclinical to clinical stages. Ernexa plans to leverage recent financing to fulfill critical upcoming milestones, positioning itself for significant value creation in the near term.
Read more →