Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis

Enlivex (Nasdaq: ENLV) received FDA IND clearance on March 23, 2026 to start a global, randomized, double-blind, placebo-controlled Phase 2b trial of Allocetra™ for moderate-to-severe age-related primary knee osteoarthritis.

Rhea-AI Summary

Enlivex (Nasdaq: ENLV) received FDA IND clearance on March 23, 2026 to start a global, randomized, double-blind, placebo-controlled Phase 2b trial of Allocetra™ for moderate-to-severe age-related primary knee osteoarthritis.

The clearance follows positive 3- and 6-month Phase 1/2a data in 134 patients showing a statistically significant, durable treatment effect in older patients. The Phase 2b is powered to assess pain and physical function at three and six months plus quality-of-life and mobility endpoints.

Positive

• FDA IND clearance obtained for Phase 2b of Allocetra
• Phase 1/2a showed statistically significant 3- and 6-month effects in 134 patients
• Phase 2b is statistically powered to evaluate pain and physical function endpoints

Negative

• IND is not marketing approval; successful Phase 2b and further regulatory steps remain required

Argus Mar 23 session

+8.82% close to close Open Argus

Details

News Market Reaction – ENLV

On Mar 23, the day this news came out, ENLV closed 8.82% above the previous close.

Data tracked by StockTitan Argus for the Mar 23 session.

Key Figures

Phase 1/2a enrollment: 134 patients U.S. OA prevalence: More than 32 million Americans Projected U.S. OA cases: 78 million Americans by 2040 +5 more

Phase 1/2a enrollment

134 patients

Multicenter randomized double-blind placebo-controlled trial in knee osteoarthritis

U.S. OA prevalence

More than 32 million Americans

Current age-related primary knee osteoarthritis burden

Projected U.S. OA cases

78 million Americans by 2040

Projected age-related primary knee osteoarthritis burden

ATM offering size

$250,000,000

Ordinary shares offered under updated at-the-market program

Initially registered ATM

$299,553,108

Original amount registered under the Sales Agreement

Shares sold via ATM

1,936,660 shares

Aggregate sales from November 24, 2025 through supplement date

ATM gross proceeds

$2,513,111

Aggregate gross proceeds from ATM share sales

Private placement

$212,000,000

Capital raise referenced in December 11, 2025 fireside chat

Historical Context

5 past events · Latest: Feb 10

5 events

1. Feb 10

   Crypto treasury update

   24h Move

   +0.0%

   RAIN token listed on Kraken to enhance liquidity and access.

2. Jan 26

   Crypto treasury update

   24h Move

   +8.3%

   RAIN token listed on WhiteBIT to expand regional market access.

3. Jan 23

   Listing change

   24h Move

   +2.9%

   Voluntary delisting from TASE to trade shares exclusively on Nasdaq.

4. Jan 07

   Crypto treasury update

   24h Move

   +0.4%

   RAIN token begins trading on KuCoin, a major global exchange.

5. Dec 04

   Financing & strategy

   24h Move

   +6.4%

   Fireside chat after $212M private placement to discuss RAIN and Allocetra.

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

Key Terms

investigational new drug (ind), phase 2b, placebo-controlled, intra-articular injections, +4 more

8 terms

investigational new drug (ind) regulatory

"has cleared its Investigational New Drug (IND) application for Allocetra™"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

phase 2b medical

"late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

placebo-controlled medical

"multicenter, randomized, double-blind, placebo-controlled clinical trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

intra-articular injections medical

"evaluate the efficacy and safety of intra-articular injections of Allocetra™"

Intra-articular injections are treatments where medication or other therapeutic agents are injected directly into a joint space, like putting oil straight into a car hinge to reduce friction. For investors, they matter because they represent a targeted way to treat joint pain or disease that can reduce side effects and sometimes improve outcomes, influencing a product’s clinical appeal, market demand, regulatory pathway, and potential revenue.

at-the-market offering financial

"updating an at-the-market offering: it is now offering up to"

An at-the-market offering is a method companies use to sell new shares of stock directly into the open market over time, rather than all at once. This allows them to raise money gradually, similar to selling small pieces of a product instead of a large batch. For investors, it means the company can access funding more flexibly, but it may also increase the supply of shares and influence the stock’s price.

rule 424(b)(3) regulatory

"Prospectus Filed Pursuant to Rule 424(b)(3)"

Rule 424(b)(3) is a U.S. Securities and Exchange Commission filing rule that governs how updated prospectus information about a securities offering is formally added to an existing registration statement. For investors, seeing a 424(b)(3) filing means the company has officially recorded new offering details – like the number of shares, pricing range or other terms – so it’s a reliable place to check the latest, legally required disclosures; think of it as the official addendum to a product manual that must be filed before the product is sold.

form 3 regulatory

"title": "[Form 3] Enlivex Ltd. Initial Statement of Beneficial Ownership""

Form 3 is the initial public filing that officers, directors and large shareholders must submit to report their ownership of a company’s securities when they become insiders. It acts like an opening inventory sheet that gives investors a starting point to see who holds significant stakes and to spot later trades or potential conflicts of interest, helping assess insider confidence and transparency.

private placement financial

"plans after a $212,000,000 private placement, including a new digital asset"

A private placement is a sale of securities directly to a selected group of investors, typically institutions or accredited investors, instead of through a public offering. It lets a company raise money faster and with fewer regulatory steps; for existing shareholders it matters because the newly issued shares, often sold at a discount, increase the share count and can dilute their ownership.

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

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• Enlivex’s first regulatory approval for a late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis following the implementation of its dual-engine value creation model:  A clinical-stage quality longevity program powered by a prediction markets treasury strategy.
   
• IND clearance follows the positive 3 and 6-month data readout from the Company’s Phase 1/2a multicenter, randomized, double-blind, placebo-controlled clinical trial, which enrolled 134 patients, and demonstrated a robust, durable, clinically meaningful, and statistically significant treatment effect in older patients with knee osteoarthritis.

Nes-Ziona, Israel, March 23, 2026 (GLOBE NEWSWIRE) -- Enlivex Ltd. (Nasdaq: ENLV) (“Enlivex” or the “Company”), a quality longevity company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Allocetra™, the Company’s clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA).

The FDA’s clearance enables Enlivex to initiate a global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™ in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis, which is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040.

This is the first regulatory clearance obtained by the Company following the implementation of its dual-engine value creation model, which is centered on the development of a clinical-stage quality longevity program powered by a prediction markets treasury strategy.

Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to have received FDA clearance to initiate the Phase 2b clinical trial of Allocetra™ in patients with age-related primary knee osteoarthritis. This milestone represents an important step toward our mission of improving the quality of life of an aging population that is suffering from this debilitating disease with poor availability of treatment options. In our previous clinical study, Allocetra™ demonstrated a robust, durable, and clinically meaningful treatment effect lasting at least six months, with increasing benefit observed in older patient populations. We look forward to enrolling the first patients into the Phase 2b and believe Allocetra™ has the potential to address a major unmet medical need for elderly patients suffering from knee osteoarthritis while supporting a strong commercial opportunity for Enlivex.”

The Phase 2b trial has been designed to be statistically powered to evaluate key efficacy endpoints, including change from baseline in pain and physical function compared with placebo, measured at three- and six-months following treatment. Additional endpoints include changes in quality-of-life measures and functional mobility assessments.

About Enlivex (Nasdaq: ENLV)

Enlivex is a quality longevity Company powered by a prediction markets treasury. The Company is advancing Allocetra™, an advanced clinical-stage immunotherapy targeting inflammatory conditions associated with aging with a primary focus on age-related osteoarthritis.

In addition to its clinical programs, Enlivex operates a prediction markets treasury strategy built around the RAIN protocol, the leading decentralized prediction markets infrastructure on Arbitrum. This dual-engine structure combines the development of quality longevity therapeutics with exposure to the emerging prediction markets ecosystem.

About Knee Osteoarthritis

Knee osteoarthritis (KOA) is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. There are currently no approved disease modifying therapies; treatment is largely limited to pain relief, intra articular steroids, or surgery, and the burden increases sharply with age. By age 60, KOA affects roughly 30% of the population, and about half of knee OA patients are 60 years and older. This demographic is expanding with global aging trends, underscoring the need for new, durable therapies.

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. These forward-looking statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,” “intends,” “estimates,” “suggests,” “target,” “has the potential to,” “goal,” and other words of similar meaning, including statements relating to the anticipated benefits of the Company’s digital asset treasury strategy; the assets to be held by the Company; the expected future market, price, trading activity, and liquidity of the RAIN token; the impact of expanded exchange listings and increased token liquidity on market participation and accessibility; the potential effects of digital asset liquidity on the liquidity of the Company’s ordinary shares; macroeconomic, political, and regulatory conditions surrounding digital assets; the Company’s plans for value creation and strategic positioning; market size and growth opportunities; regulatory conditions; competitive position; technological and market trends; future financial condition and performance; expected clinical trial results; market opportunities for the results of current clinical studies and preclinical experiments; and the effectiveness of, and market opportunities for, ALLOCETRA™ programs.

Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the risk of failure to realize the anticipated benefits of the Company’s digital asset treasury strategy; changes in business, market, financial, political, and regulatory conditions; risks relating to the Company’s operations and business, including the highly volatile nature of the price, trading volume, and liquidity of RAIN and other cryptocurrencies; risks associated with digital asset exchange listings, trading venues, and market infrastructure; the risk that the price and liquidity of the Company’s ordinary shares may be correlated with the price or liquidity of the digital assets it holds; risks related to increased competition in the industries in which the Company operates; risks relating to significant legal, commercial, regulatory, and technical uncertainty regarding digital assets generally; risks relating to the treatment of crypto assets for U.S. and foreign tax purposes; and those risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements, except as required by applicable law.

ENLIVEX CONTACT

Shachar Shlosberger, CFO
Enlivex Ltd.
shachar@enlivex.com

FAQ

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

What does Enlivex's FDA IND clearance for Allocetra (ENLV) on March 23, 2026 mean?

It means Enlivex can begin a global Phase 2b trial of Allocetra for knee osteoarthritis. According to the company, the clearance permits a randomized, double-blind, placebo-controlled study evaluating intra-articular Allocetra injections in moderate-to-severe age-related knee OA.

What evidence supported Enlivex's IND clearance for Allocetra (ENLV)?

The clearance follows positive Phase 1/2a 3- and 6-month data in 134 patients showing a durable, statistically significant treatment effect. According to the company, benefit increased in older patient subgroups in that randomized, placebo-controlled study.

What endpoints will Enlivex evaluate in the Phase 2b Allocetra trial (ENLV)?

The Phase 2b will assess change from baseline in pain and physical function versus placebo at three and six months. According to the company, additional endpoints include quality-of-life measures and functional mobility assessments.

How large and rigorous is the planned Phase 2b trial for Allocetra (ENLV)?

The planned trial is a global, multicenter, randomized, double-blind, placebo-controlled Phase 2b designed to be statistically powered for key efficacy endpoints. According to the company, the design targets robust assessment of pain and function outcomes.

Does the FDA IND clearance for Allocetra (ENLV) equal approval to market the drug?

No, IND clearance allows clinical testing but is not marketing approval. According to the company, successful Phase 2b results and subsequent regulatory steps will be required before any approval or commercialization.