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Ernexa Therapeutics Inc.

ERNA
Richly ValuedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$2.96
▲ 0 · 0%

Financials

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52W LOW $2.8452W HIGH $71.50
Volume
40.81 K
Value Traded
319.73 K
Short % Float
1.26%
-14.7%Week
-29.36%1 Month
-54.04%3 Month
-43.54%6 Month
-99.99%5 Year
-100%All Time

Cash Data

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Key Stats

Market Cap
4.83 M
EPS (TTM)
-10.51
P/E Ratio
-
Ent. Value
-196.06 K
Total Shares
1.63 M
Float Shares
1.14 M
Insiders
30.04%
Institutions
2.21%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Pre-clinical data presentation
ERNA-101
platinum-resistant ovarian cancer
Pre-clinicalCell TherapiesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ERNA Catalyst Timeline

Dated clinical, regulatory and corporate events for Ernexa Therapeutics Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Ernexa Therapeutics Inc.

136Total events
17Upcoming
14Tier-1 (high impact)
2016 to 2027Coverage

Upcoming catalysts 2

T2Trial Initiation
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ERNA-101
T3Pre IND Meeting
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ERNA-201Discontinued

Event history 50

▲Preclinical PoCERNA-101Preclinical
ERNA-101 plus anti-PD-1 showed complete tumor clearance and 100% survival in ovarian cancer model
ovarian cancersource ↗
▼Pipeline PrioritizationERNA-201DiscontinuedCorporate
Ernexa pauses additional preclinical development expenditures on ERNA-201 to focus on ERNA-101
▲Preclinical PoCERNA-101Preclinical
ERNA-101 repeat-dose GLP toxicology showed no related adverse findings at any dose level
ovarian cancersource ↗
▲IND Enabling CompleteERNA-101Preclinical
Core IND-enabling safety studies complete
platinum-resistant ovarian cancersource ↗
●Management ChangeCorporate
Robert J. Spiegel, M.D., FACP appointed to Board of Directors
●R&D DayPresentation
Ernexa CEO to present at H.C. Wainwright 28th Annual Global Investment Conference
▲Preclinical PoCERNA-201DiscontinuedPreclinical
ERNA-201 demonstrates disease-modifying activity in CIA model
rheumatoid arthritis and inflammatory joint diseasesource ↗
▲Platform ValidationPreclinical
ERNA-201 results validate synthetic iMSC platform beyond oncology
▼Program DiscontinuationERNA-201DiscontinuedCorporate
Ernexa pauses additional preclinical development expenditures on ERNA-201
rheumatoid arthritis and inflammatory joint diseasesource ↗
●Pipeline PrioritizationCorporate
Ernexa sharpens oncology strategy, prioritizes ERNA-101
oncologysource ↗
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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 %
2026-05-13ERNA-101 Pre-clinical data readout Pre-clinical
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D21 / 100
Pipeline Score
$0M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.1x
rNPV / MCap
Top 94%
Micro Cap
(rank 619 of 658)
Percentile Rank
Ernexa Therapeutics Inc. faces pipeline headwinds (21/100), with $240M risk-adjusted pipeline value, led by IRX-2 in Squamous Cell Carcinoma of the Oral Cavity (Phase 2), but cash runway is a concern.
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
IRX-2 Monoclonal antibodyCompletedNCT02609386Squamous Cell Carcinoma of the Oral CavityPhase 2 COMPLETED 105Feb 28, 2022
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Clinical Trial Results

Readouts, endpoints and source filings for every ERNA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ERNA-101 cancer2026-09-30No 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 MoreErnexa Therapeutics Reports Compelling ERNA-101 Safety Results Across Three Critical IND-Enabling Studies, Advancing Toward Planned Q4 2026 INDRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Cherington Charles10% OwnerBuy 4,000,000 6,779,440 held$0.50 02/10/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in ERNA for Q2 2026.
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ERNA Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Real-Time Option Chain

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Competitive positioning

How ERNA ranks across every disease it competes in

Competitive Position is a premium feature
See how ERNA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ERNA News

-ERNA
Oct 1, 2026
ERNAPhases
▼ -7.5%on this 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.

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-ERNA
Sep 30, 2026
ERNAPhases

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 →
-ERNA
Sep 29, 2026
ERNAConferences/Events
▼ -8.9%on this newsshared move

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.

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-ERNA
Sep 17, 2026
ERNAGeneral

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.

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-ERNA
Sep 15, 2026
ERNAPhases

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.

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-ERNA
Sep 14, 2026
ERNAConferences/Events

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.

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-ERNA
Aug 27, 2026
ERNAConferences/Events

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.

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-ERNA
Aug 10, 2026
ERNAGeneral
▲ +7.6%on this news

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.

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-ERNA
Jul 24, 2026
ERNAPhases

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.

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-ERNA
Jul 15, 2026
ERNAPhases
▲ +11.1%on this news

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.

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-ERNA
Jul 14, 2026
ERNAPhases
▲ +9.4%on this news· ran to +21% by day 1shared move

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 →
-ERNA
Jun 25, 2026
ERNAGeneral
▲ +17.5%on this news

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.

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-ERNA
Jun 17, 2026
ERNAPhases

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.

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-ERNA
Jun 9, 2026
ERNAGeneral
▼ -8%on this news

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.

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-ERNA
May 27, 2026
ERNAPhases

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.

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-ERNA
May 20, 2026
ERNAConferences/Events

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.

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-ERNA
May 11, 2026
ERNAConferences/Events

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.

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-ERNA
May 6, 2026
ERNAPhases
▲ +51.4%on this news· ran to +96% by day 1shared move

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.

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-ERNA
Apr 30, 2026
ERNAGeneral
▼ -21.2%on this news

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.

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-ERNA
Mar 31, 2026
ERNAPhases
▲ +5.3%on this news

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.

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About Ernexa Therapeutics Inc.

Cambridge, MA 5 employees ernexatx.com
Headquarters1035 CAMBRIDGE STREET, CAMBRIDGE, MA, 02141
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