Ernexa Therapeutics Announces Successful Pre-IND FDA Meeting and Continues Progress Toward First-in-Human Trial in Ovarian Cancer

Ernexa Therapeutics (Nasdaq: ERNA) completed a Pre-IND meeting with the FDA on Jan 6, 2026, securing regulatory alignment on its development approach for cell therapies.

Rhea-AI Summary

Ernexa Therapeutics (Nasdaq: ERNA) completed a Pre-IND meeting with the FDA on Jan 6, 2026, securing regulatory alignment on its development approach for cell therapies.

The company said the FDA set a clear pathway toward an IND and the first-in-human (FIH) trial for ovarian cancer is expected in the second half of 2026. Tech transfer for clinical manufacturing is already underway to accelerate production of clinical-grade material and trial readiness.

Ernexa is advancing two allogeneic iMSC programs: ERNA-101 (ovarian cancer) and ERNA-201 (autoimmune disease), with initial clinical development focused on ERNA-101.

Positive

• FDA Pre-IND meeting provided regulatory alignment
• FIH trial for ovarian cancer targeted H2 2026
• Tech transfer for clinical manufacturing is underway
• Pipeline includes two allogeneic iMSC programs (ERNA-101, ERNA-201)

Negative

• IND submission remains pending before clinical dosing
• No clinical efficacy data reported yet for ERNA-101

Argus Jan 6 session

+4.96% close to close Open Argus

Details

News Market Reaction – ERNA

On Jan 6, the day this news came out, ERNA closed 4.96% above the previous close.

Data tracked by StockTitan Argus for the Jan 6 session.

Key Figures

Q3 2025 net loss: $1.24 million YTD 2025 net loss: $12.58 million Cash balance: $3.05 million +5 more

Q3 2025 net loss

$1.24 million

Quarter ended Sept 30, 2025 vs $26.60M prior year

YTD 2025 net loss

$12.58 million

Nine months ended Sept 30, 2025 vs $38.78M 2024

Cash balance

$3.05 million

As of Sept 30, 2025

Operating cash use

$5.87 million

Operating cash used year-to-date 2025

Private placement proceeds

$7.20 million

Gross proceeds from common stock and pre-funded warrant sales in 2025

Forward contract expense

$5.85 million

Non-cash forward sales contract expense tied to 2025 private placement

Shares outstanding

7,848,889 shares

Common shares outstanding as of Nov 7, 2025

Phase 1 timing

H2 2026

Targeted start of first-in-human trial for ERNA-101

Historical Context

5 past events · Latest: Dec 08

5 events

1. Dec 08

   Preclinical data update

   24h Move

   -1.5%

   New ERNA-101 preclinical data showing strong immune activation and survival benefit.

2. Dec 03

   Conference presentation

   24h Move

   -4.2%

   Announcement of oral ASH presentation on iMSC platform and ERNA-101 data.

3. Dec 02

   Advisory board change

   24h Move

   -4.0%

   Appointment of leading gynecologic oncologist to strengthen clinical guidance.

4. Nov 11

   Conference participation

   24h Move

   -5.4%

   Planned presentations on development, funding, and regulatory strategies at Cell 2025.

5. Nov 10

   Operational update

   24h Move

   -4.6%

   Reported reduced operating loss and outlined IND and Phase 1 trial timelines.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pre-investigational new drug application, pre-ind, first-in-human, allogeneic, +4 more

8 terms

pre-investigational new drug application regulatory

"successful completion of its recent Pre-Investigational New Drug Application (Pre-IND) meeting"

A pre-investigational new drug application is an early meeting and written exchange between a drug developer and the regulatory agency to review plans before formally submitting an Investigational New Drug (IND) application. It matters to investors because it helps identify scientific, safety, manufacturing or data gaps early—like a rehearsal that can reduce the risk of costly delays or extra work and give a clearer idea of development timelines and regulatory hurdles.

pre-ind regulatory

"Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

first-in-human medical

"on track to initiate first-in-human (FIH) trial for the treatment of ovarian cancer"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

allogeneic medical

"two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies"

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

induced mesenchymal stem cell medical

"two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies"

An induced mesenchymal stem cell is a cell that has been converted in the lab from another cell type to behave like a natural mesenchymal stem cell, capable of becoming connective tissues (bone, cartilage, fat) and calming inflammation. Think of it as retraining a worker to perform a new, valuable job; for investors this matters because these lab-made cells are the basis for potential therapies, manufacturing and regulatory risk, intellectual property, and future revenue if safety and effectiveness are proven.

induced pluripotent stem cells medical

"Built from reprogrammed induced pluripotent stem cells (iPSCs), Ernexa’s engineered iMSCs"

Induced pluripotent stem cells (iPSCs) are adult cells that scientists have reprogrammed to behave like embryonic stem cells, meaning they can become many different cell types. For investors, iPSCs matter because they are a flexible platform for developing new drugs, testing safety, and creating personalized therapies; think of them as blank building blocks that can be used to prototype treatments and reduce development risk before large clinical bets.

cytokines medical

"deliver potent therapeutic cytokines directly to the disease site"

Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.

u.s. food and drug administration regulatory

"meeting with the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Regulatory alignment supports rapid progress, tech transfer already underway to accelerate clinical readiness

Company on track to initiate first-in-human (FIH) trial for the treatment of ovarian cancer in the second half of 2026

CAMBRIDGE, Mass., Jan. 06, 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 the successful completion of its recent Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). Feedback from the FDA provided strong regulatory alignment on Ernexa’s development approach and set a clear pathway toward submitting the IND and initiating its first-in-human (FIH) trial for the treatment of ovarian cancer, expected in the second half of 2026.

Following the meeting, Ernexa has accelerated key operational activities. Tech transfer – one of the most significant milestones in preparing for clinical manufacturing – is already underway, positioning the company to rapidly advance toward production of clinical-grade material and trial readiness.

“We are very pleased with the outcome of our engagement with the FDA,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “The Agency’s feedback validates our development strategy and gives us the green light to move forward with urgency. With tech transfer now in progress, we are operating at full speed to bring our first-in-human studies online in 2026. This is a major step toward delivering transformative cell therapies to patients with serious and underserved diseases.”

Ernexa is currently advancing two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies – ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. Built from reprogrammed induced pluripotent stem cells (iPSCs), Ernexa’s engineered iMSCs are designed to actively home in on tumors or inflamed tissues and deliver potent therapeutic cytokines directly to the disease site. This targeted, off-the-shelf approach aims to overcome key limitations of traditional MSC therapies while enabling scalable manufacturing and broad patient accessibility.

The company’s initial clinical development will focus on ERNA-101 for the treatment of ovarian cancer, a disease with limited effective targeted therapies and high recurrence rates.

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative stem cell therapies for the treatment of advanced cancer and autoimmune disease. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s synthetic, allogeneic iMSCs provide a scalable, off-the-shelf treatment, 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. Forward-looking statements are based upon Ernexa's current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa's risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.

Media Contact
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

Investor Contact
Jenene Thomas
JTC Team, LLC
(908) 824-0775
ENRA@jtcir.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Ernexa announce about its FDA Pre-IND meeting on Jan 6, 2026 (ERNA)?

Ernexa said the FDA provided regulatory alignment and set a clear pathway toward submitting an IND.

When does Ernexa expect to start the first-in-human ERNA-101 trial for ovarian cancer?

Ernexa expects to initiate the ERNA-101 FIH trial in the second half of 2026.

What operational step is Ernexa undertaking to prepare for clinical trials (ERNA)?

Ernexa has begun tech transfer to enable production of clinical-grade material and trial readiness.

Which programs are in Ernexa's clinical pipeline and which is prioritized (ERNA)?

Ernexa is advancing ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease, prioritizing ERNA-101.

Does Ernexa have clinical data or an active IND for ERNA-101 (ERNA)?

No; the company reported regulatory alignment but said the IND submission and clinical dosing are still pending.