Enlivex Announces Favorable 12-Month Topline Data from Phase I/IIa Allocetra Trial, Demonstrating Durable Treatment Response

The 12-month responder comparison favored Allocetra, while separate pain and function comparisons did not reach statistical significance.

Rhea-AI Summary

Enlivex (ENLV) announced 12-month Allocetra results from the randomized, placebo-controlled Phase IIa stage of its knee osteoarthritis trial. Among patients aged 64+, 79.2% receiving Allocetra achieved reduced pain and improved knee function versus 47.6% receiving placebo (p=0.027), following one three-injection treatment cycle.

The responder benefit persisted through one year, but separate 12-month pain and function comparisons did not reach statistical significance: differences versus placebo were -12.2 points (p=0.113) and -13.1 points (p=0.067), respectively. No treatment-related serious adverse events occurred; adverse events were predominantly transient, mild to moderate local knee reactions. The Phase IIa stage randomized and treated 134 patients overall. Enlivex expects topline results from its ongoing Phase IIb trial in the same older population by the end of the second quarter of 2027.

8 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPatients aged 64+ had 79.2% responders versus 47.6% with placebo at 12 months (p=0.027).
• Minor pointResponder rates in patients aged 64+ were 80% higher versus placebo at three months (p=0.019).
• Minor pointPain differences versus placebo in patients aged 64+ were -17.5 points at three months and -15.4 at six months (p=0.004; p=0.012).
• Minor pointFunction differences versus placebo in patients aged 64+ were -19.3 points at three months and -19.5 at six months (both p=0.0008).
• Minor pointSafety follow-up through 12 months found no treatment-related serious adverse events.

3 minor points

• Minor pointAge was the strongest predictor of treatment response across analyses, with treatment effects increasing with age.
• Minor pointPhysical performance tests and exploratory biomarker and imaging analyses supported patient-reported improvements.
• Minor point. Forward-looking: it has not happened yet and may not happen.Enlivex expects ongoing Phase IIb trial topline results by the end of the second quarter of 2027.

Negative

• Minor pointTwelve-month pain differences in patients aged 64+ favored Allocetra by 12.2 points but were not statistically significant (p=0.113).
• Minor pointTwelve-month function differences in patients aged 64+ favored Allocetra by 13.1 points but were not statistically significant (p=0.067).
• Minor pointSix-month responder rates in patients aged 64+ were 39% higher versus placebo but not statistically significant (p=0.168).
• Minor pointAdverse events were predominantly transient, mild to moderate local knee reactions.

Argus 15 min delay 16 alerts

-12.04% vs previous close $1.57 last price 0.4x rel. volume Open Argus

Details

Market move: ENLV -12.04% vs previous close. 12-month Phase IIa clinical data

-12.9% Trough in 31 min

$1.48 – $2.05 Day Range

$2.40M Mkt Cap at Last Price

On Nov 2, the day this news came out, the latest delayed price for ENLV is 12.04% below the previous close. Argus tracked a trough of -12.9% from its starting point during tracking. Our momentum scanner has recorded 16 alerts for this stock so far that day. The latest delayed price is $1.57.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

12-month responder rate: 79.2% vs. 47.6%; p=0.027 WOMAC pain difference: -12.2 points; p=0.113 WOMAC function difference: -13.1 points; p=0.067 +2 more

12-month responder rate

79.2% vs. 47.6%; p=0.027

Age 64+; Allocetra vs. placebo

WOMAC pain difference

-12.2 points; p=0.113

12 months, age 64+; difference vs. placebo on a 0–100 scale

WOMAC function difference

-13.1 points; p=0.067

12 months, age 64+; difference vs. placebo on a 0–100 scale

Patients randomized and treated

134 patients

Phase IIa stage of ENX-CL-05-001

Treatment regimen

3 injections

Single Allocetra treatment cycle

Previous Clinical trial Reports

2 past events · Latest: Oct 28

Same Type 2 events

1. Oct 28

   Phase 2b enrollment

   24h Move

   -3.3%

   Phase IIb randomized 135 patients in the same age-related knee osteoarthritis program; topline data expected mid-2027.

2. Nov 24

   Phase IIa data

   24h Move

   +13.7%

   Earlier Phase IIa topline reported six-month pain and function improvements versus placebo in age-related patients.

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

Key Terms

womac, intra-articular, double-blind, placebo-controlled, +1 more

5 terms

womac medical

"WOMAC pain: -17.5 points at 3 months"

A WOMAC is a standardized questionnaire patients complete to rate joint pain, stiffness, and ability to perform everyday activities, most often used for osteoarthritis. Think of it as a customer-satisfaction score for joints that translates how people actually feel and function into numbers. Investors watch WOMAC results because they are commonly used to show whether a treatment meaningfully helps patients, influencing regulatory approval, prescribing decisions and market value.

intra-articular medical

"Innovative Intra-Articular Apoptotic Cell Therapy"

An intra-articular treatment is one that is injected directly into a joint space, such as the knee or shoulder, to deliver medication or therapy right where the problem is. For investors, this matters because intra-articular delivery can improve effectiveness and reduce systemic side effects compared with pills or injections elsewhere in the body, affecting a drug’s clinical value, regulatory pathway, market appeal, and reimbursement prospects.

double-blind medical

"randomized, double-blind, placebo-controlled Phase IIa stage"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase IIa stage"

"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.

omeract-oarsi responder criteria medical

"Under the OMERACT-OARSI responder criteria"

A standardized clinical-trial rule used in osteoarthritis studies to classify whether an individual patient has meaningfully responded to treatment. A participant is designated a responder if they meet a high-improvement threshold in pain or physical function (commonly defined as ≥50% improvement and an absolute change meeting a prespecified minimum on a 0–100 scale) or if they show smaller but concordant improvements in at least two of three core measures (pain, function, and patient global assessment), usually defined by both a relative percentage change (commonly ≥20%) and a minimum absolute change. The criteria are a consensus measurement tool, so they describe how response is measured rather than prescribing treatment, and specific numeric cutoffs can vary slightly by study protocol.

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

• In patients aged 64+: 79.2% of patients achieved a clinically meaningful response (reduced pain and improved knee function) in the Allocetra™ group vs. 47.6% in the placebo group at 12 months (p=0.027)¹
   
• Allocetra™ treatment benefit at 12 months was consistent with the response rates observed at 3 and 6 months, demonstrating a durable effect from a single treatment cycle
  
  
• The 12-month data will be presented at the American College of Rheumatology (ACR) Convergence in a poster presentation on November 8, 2026

Nes-Ziona, Israel, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Enlivex Ltd. (Nasdaq: ENLV) ("Enlivex" or the "Company"), a quality longevity company powered by a prediction markets treasury, today announced favorable 12-month topline data from the randomized, double-blind, placebo-controlled Phase IIa stage of the Company's multi-country Phase I/IIa trial (ENX-CL-05-001) evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis. With 12-month follow-up now complete, the data show that a single three-injection treatment cycle of Allocetra™ produced a sustained treatment response through one year in patients with primary age-related knee osteoarthritis, the population being evaluated in the Company's ongoing Phase IIb trial. The one-year safety and efficacy results have been selected for a poster presentation at the American College of Rheumatology (ACR) Convergence 2026 (details below).

Summary of the 12-month Topline Data, Age Group 64+

• Sustained responder benefit at one year: The proportion of patients (age 64+) achieving a clinically meaningful response² (reduced pain and increased knee function) was 66% higher for the Allocetra™ group than for the placebo group at 12 months, consistent with the treatment benefit observed at the earlier 3- and 6-month timepoints:
   
  • At 12 months: 79.2% responders in the Allocetra™ group vs. 47.6% in the placebo group (p=0.027)
  • This substantial treatment benefit was consistent with the response rates observed at 3 months (80% higher for the Allocetra™ group than for the placebo group; p=0.019) and 6 months (39%  higher for the Allocetra™ group than for the placebo group; p=0.168).
     
• Improvement in pain and function maintained through 12 months: Allocetra™ produced statistically significant and clinically meaningful improvements versus placebo at 3 and 6 months. At 12 months, treatment differences continued to favor Allocetra™ and were reasonably maintained throughout one year (scale 0–100; difference vs. placebo in change from baseline), in the 64+ age group:
   
  • WOMAC³ pain: -17.5 points at 3 months (p=0.004), -15.4 points at 6 months (p=0.012), and -12.2 points at 12 months (p=0.113)
  • WOMAC function: -19.3 points at 3 months (p=0.0008), -19.5 points at 6 months (p=0.0008), and -13.1 points at 12 months (p=0.067)
     
• Consistent age-related effect: Across analyses, patient age was the strongest predictor of treatment response, with the treatment effect increasing with age. Improvements in patient-reported outcomes were supported by objective physical performance tests and by exploratory serum biomarker and imaging analyses consistent with Allocetra™'s proposed macrophage-reprogramming mechanism of action.
   
• Favorable safety profile through 12 months: No treatment-related serious adverse events were observed. Adverse events were predominantly transient, mild to moderate local knee reactions, consistent with previously reported data.

12-month data presentation at the ACR convergence

ACR Convergence 2026 is taking place November 6–11, 2026 at the Orange County Convention Center in Orlando, Florida.

The poster will be presented by Prof. Philip Conaghan, Consultant Rheumatologist and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan is an international leader in osteoarthritis and musculoskeletal imaging who has authored more than 700 publications and chaired multiple global guideline and clinical trial initiatives.

Poster Presentation

• Title: Durable Clinical Efficacy of an Innovative Intra-Articular Apoptotic Cell Therapy in Knee Osteoarthritis: Age-Related Effect Through One Year
   
• Abstract ID: 24454477
   
• Session: Poster Session A (0632–0644): Osteoarthritis – Clinical Poster A
   
• Date & Time: November 8, 2026 | 10:30 AM – 12:30 PM ET

"The 12-month results show that a single treatment cycle of Allocetra™ delivered a clinically meaningful benefit in older patients with knee osteoarthritis that was sustained through one year. In a disease with no approved disease-modifying therapies, where treatment is largely limited to symptom management or surgery, a durable response from a single treatment cycle could offer a differentiated profile for patients, physicians and payers. We are pleased that these data were selected for presentation at ACR Convergence 2026, and we look forward to topline data from our Phase IIb trial, which is enrolling this same population, by the end of the second quarter of 2027," said Dr. Oren Hershkovitz, Chief Executive Officer of Enlivex.

About ENX-CL-05-001

ENX-CL-05-001 is a multi-center Phase I/IIa clinical trial consisting of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee, in order to identify the dose and injection regimen for the subsequent Phase IIa stage. The Phase IIa stage was a double-blind, randomized, placebo-controlled multi-centered trial where 134 patients were randomized and treated.

About Knee Osteoarthritis

Osteoarthritis (OA) is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to continue and grow substantially, with knee OA (KOA) being the most prevalent form. 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 KOA patients are 60 years of age or older. This demographic is expanding with global aging trends, underscoring the need for new, durable therapies.

About Enlivex

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 strategy combines the development of quality longevity therapeutics with exposure to the emerging prediction markets ecosystem.

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 that results from subgroup analyses and small patient populations, including those described in this press release, may not be replicated in larger trials, including the Company's ongoing Phase IIb trial; the risk that topline data may change following a more comprehensive review of the data; the risk that RMAT designation may not lead to a faster development or regulatory review process and does not increase the likelihood of approval; risks related to the timing, conduct and outcome of clinical trials and regulatory submissions; 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 

---

¹ Summary of the 12-month Topline Data, Age Group 64+

² Under the OMERACT-OARSI responder criteria, the established standard for osteoarthritis trials

³ WOMAC: a widely used, standardized questionnaire to evaluate the condition and quality of life of patients with osteoarthritis of the hip and knee

FAQ

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

What did Enlivex's Allocetra trial show at 12 months?

Among patients aged 64+, 79.2% receiving Allocetra met the responder criteria versus 47.6% receiving placebo (p=0.027). Separate pain and function comparisons favored Allocetra but did not reach statistical significance at 12 months.

When does Enlivex expect Allocetra Phase IIb topline results?

Enlivex expects topline results by the end of the second quarter of 2027. The ongoing Phase IIb trial is enrolling the same population with primary age-related knee osteoarthritis evaluated in the older-patient analysis.

How was a responder defined in Enlivex's Allocetra knee osteoarthritis trial?

Response was assessed using the OMERACT-OARSI responder criteria, an established standard for osteoarthritis trials. The reported clinically meaningful response covered reduced pain and improved knee function.

When will Enlivex present the Allocetra 12-month data at ACR Convergence 2026?

The poster presentation is scheduled for November 8, 2026, from 10:30 AM to 12:30 PM ET at ACR Convergence in Orlando, Florida. Prof. Philip Conaghan will present the one-year safety and efficacy results.