Ernexa Therapeutics Inc (ERNA)

Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development
Company remains on track for anticipated IND filing in Q3 2026, marking a transformative step toward becoming a clinical-stage biotechnology company
CAMBRIDGE, Mass., May 27, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.

The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.

“These achievements represent a defining moment for Ernexa Therapeutics,” said Sanjeev Luther, CEO of Ernexa Therapeutics. “Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND filing in the third quarter of 2026, Most importantly, we believe ERNA-101 has the potential to bring new hope to patients and families in need of better therapeutic options.”

The advancement of ERNA-101 reflects continued momentum across the company’s development and manufacturing operations and marks an important evolution in Ernexa’s corporate trajectory toward becoming a clinical-stage biotechnology company.

“With technology transfer now in progress and manufacturing activities advancing as planned, we believe Ernexa is entering a transformational phase,” added CEO, Sanjeev Luther. “These milestones will significantly strengthen our operational readiness and reinforce our confidence in the path toward clinical evaluation of ERNA-101.”

ERNA-101 is being advanced as part of Ernexa Therapeutics’ broader mission to develop innovative therapies designed to address significant unmet medical needs.

Key Highlights

IND submission for ERNA-101 targeted for Q3 2026
Technology transfer activities currently in progress
Process development for ERNA-101 manufacturing successfully completed
Transition to GMP manufacturing underway in preparation for clinical studies
Company advancing toward anticipated transformation into a clinical-stage biotechnology company
Progress supports planned first-in-human clinical study following IND clearance
For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for the treatment of advanced cancer and autoimmune diseases. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, without needing patient-specific cell harvesting.

ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells. ERNA-201 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer.

For more information, visit www.ernexatx.com.

13.63

Shaker and baker this one. Lots of trading opportunities.

I followed you back, when I have time I'm gonna look at the tickers you like to see if I find anything INTERESTING to bet on.

agreed bud .. very strange indeed .. even stranger I find is that the pps didn't go much much higher .. that was some bad-ass news yesterday .. I guess we'll see when clinical trials in humans start but still ..

ERNA-101 achieved complete tumor clearance and 100% survival ...

https://finance.yahoo.com/sectors/healthcare/articles/ernexa-therapeutics-erna-preclinical-data-144059783.html

Ernexa Therapeutics (ERNA) Preclinical Data Shows 100% Survival and Complete Tumor Clearance in Ovarian Cancer ModelsMay 6, 2026 10:40 AM
IH Market News Ernexa Therapeutics reported new preclinical findings showing its ERNA-101 cell therapy candidate achieved complete tumor elimination and long-term survival in ovarian cancer models when combined with PD-1 blockade. Key Investor Takeaways Ernexa Therapeutics (NASDAQ:ERNA) released preclinical ovarian cancer data showing ERNA-101 achieved complete tumor clearance and 100% survival in treated mice. The results were observed when ERNA-101 was combined with anti-PD-1 checkpoint inhibitor therapy. The company said the therapy remodeled the tumor microenvironment from immunosuppressive to immune-activated. ERNA-101 is being developed as an allogeneic off-the-shelf cell therapy platform targeting difficult-to-treat solid tumors. Investors may watch for future clinical development milestones, including the planned first-in-human ovarian cancer study. Why ERNA Stock Is in Focus Ernexa Therapeutics (NASDAQ:ERNA) announced new preclinical results involving its lead cell therapy candidate ERNA-101 in ovarian cancer models.According to the company, treatment with ERNA-101 in combination with PD-1 blockade resulted in complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.The company stated that the combination significantly outperformed either therapy alone and suggested potential curative activity in the preclinical setting.Ernexa said ERNA-101 works by remodeling the tumor microenvironment (TME), converting it from an immunosuppressive state into an immune-activated environment capable of supporting stronger anti-tumor immune responses.The therapy also increased infiltration of CD4? and CD8? T cells into tumors, improved T-cell persistence and activity, reprogrammed macrophages into a cancer-fighting state, and reduced tumor burden and ascites accumulation.“This data represents a significant step forward,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics.“We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself.”The company added that ERNA-101 is derived from induced pluripotent stem cells and engineered to deliver IL-7/IL-15 fusion cytokines directly into tumors while aiming to minimize systemic toxicity.“What we are seeing goes beyond expectations,” said CEO Sanjeev Luther.“Achieving complete tumor elimination and 100% survival in a model where current approaches typically fall short reinforces both the strength of the data and the underlying mechanism driving this response.”Ernexa said it plans to use the findings to support advancement of ERNA-101 toward a first-in-human clinical trial in advanced ovarian cancer patients. Why This Matters for Investors The announcement may strengthen investor focus on ERNA-101 as a potential immunotherapy platform targeting “cold” tumors that historically respond poorly to checkpoint inhibitors.The data could also support the broader investment narrative around combination immunotherapy approaches that attempt to improve the effectiveness of existing PD-1 therapies.While the findings remain preclinical, the reported survival and tumor elimination outcomes may help validate the company’s tumor microenvironment remodeling strategy and support future clinical development efforts.At the same time, investors may continue to view the program as high-risk given the early-stage nature of the data and the uncertainty surrounding translation from animal models into human clinical outcomes.The company’s comments about potential expansion into other solid tumors may also increase attention on the scalability of the platform if future clinical studies show encouraging results. What To Watch Next Investors may monitor: Timing of ERNA-101’s planned first-in-human clinical trial Additional preclinical or translational data releases Potential regulatory milestones tied to ovarian cancer development Future combination studies involving checkpoint inhibitors Expansion of ERNA-101 into additional solid tumor indications Ernexa Therapeutics stock price Original: Ernexa Therapeutics (ERNA) Preclinical Data Shows 100% Survival and Complete Tumor Clearance in Ovarian Cancer Models

ERNA............................p/m

Fantastic news out today and crickets.... very strange even for Ihub

I remember the days when companies would do something of value to increase their share price but it seems those days are gone and every worthless ticker just reverse splits to artificially make their turd look shiny for a day or two - Very sad IMO

$ERNA: RS going down next week..................

To maintain that Nasdaq listing.


Now at $0.15


GO $ERNA

ERNA.........................https://stockcharts.com/sc3/ui/?s=ERNA&p=w&b=5&g=0&id=p86431144783

ERNA....................................a/h

Bought on the offering smackdown

1.45 the eternal cure for cancer except they never get there seems like

Zero borrow,low volume but holding up well from gap up from 1.25 and higher high today,started moving a bit freely today,thru 1.80 bullish signal could trigger,upper bolie 1.94 could see nice parabolic run with float 3m,o s 7.5m,insiders transactions up 463%,insider own 60%,not optionable and z b (1000 just showed up) target pps $9.00
32% above sma 50 and 33% below sma200 (bounced off sma 200 at 2.66 Oct 28th,thru that is $4 next res. And $5 mental.

ERNA......................................https://stockcharts.com/sc3/ui/?s=ERNA&p=W&b=5&g=0&id=p86431144783

then ran, lol

then dumped, lol, so I went to….

…

GLE. thats moving much better. weeee!!

here we go.

inching up now, lets do this.

grabbed some pre market here.

ERNA Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer https://finance.yahoo.com/news/cellipont-bioservices-ernexa-therapeutics-enter-123300008.htm

$1.87 ... Ernexa Therapeutics' most recent offering was closed on April 2025 with gross proceeds of approximately $7.1 million from the issuance of 3,181,145 shares and 622,134 prefunded warrants. The offering price was approximately $2.21 per share. This financing followed the earlier 1-for-15 reverse stock split completed on June 12, 2025

$2.09 let it come back in for a double flip 

ERNA..........................................https://stockcharts.com/sc3/ui/?s=ERNA&p=W&b=5&g=0&id=p86431144783

Exit at $2.02 mandatory this one doesn't hold up long past experience stem cell ovarian 

Let's go $1.56

Looking good for 2026 human trials ..

ERNA................................https://stockcharts.com/h-sc/ui?s=ERNA&p=W&b=5&g=0&id=p86431144783

Ernexa’s technology transforms induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs), which are a specialized type of stem cell that has a unique ability to migrate toward tumors or inflammation. Ernexa’s allogeneic synthetic iMSCs allow for enhanced predictability at scale, helping to avoid the challenges of immune rejection and donor shortages.Ernexa has two cell therapy products in development, which are undergoing preclinical trials. Its lead cell therapy product, ERNA-101, is engineered to enhance and regulate the immune system’s response, enabling it to identify and eliminate cancer cells. ERNA-102 is designed to combat inflammation and treat autoimmune disease.ERNA-101 is being developed for the treatment of ovarian cancer as its first indication. There is a significant unmet need in ovarian cancer, which currently lacks highly effective, widely applicable targeted therapies. Many patients develop resistance to the standard treatment in ovarian cancer – platinum-based chemotherapy. Other treatments have been developed but with little success.ERNA-101 and ERNA-102 have the potential to bring significant hope in the treatments of ovarian cancer and autoimmune disease, respectively.Ernexa’s ticker symbol will remain as ERNA.

ERNA....................https://stockcharts.com/h-sc/ui?s=ERNA&p=W&b=5&g=0&id=p86431144783

Getting rid of .33/34 half out .70 almost all out .93 

erna...............................https://stockcharts.com/h-sc/ui?s=erna&p=W&b=5&g=0&id=p86431144783

ERNA..............................https://stockcharts.com/h-sc/ui?s=ERNA&p=W&b=5&g=0&id=p86431144783

.33/34 at .27 average this round 

erna.......................https://stockcharts.com/h-sc/ui?s=erna&p=W&b=5&g=0&id=p86431144783

.3256

.30 +
20%

.32 the .20s will pay off

$26-.27s looking better at .28

Back in at .28 and they halt it

The power of loading heavy at .28 beat down pays off

Add .28s how low can she go longer term play perhaps 

Back in at .30-.31 beat down price 

ERNA........................................https://stockcharts.com/h-sc/ui?s=ERNA&p=W&b=5&g=0&id=p86431144783

70% profit out in .70s  paid off to load .40s

Add.40-.42

Back in .45 still have share buyback in place 

.63 once it floats through weak resistance at .69-.71 off to dollar land $1

.60 ..Even better off to $1 where it was last week