Leukocyte cell therapy (Enlivex Therapeutics)

- Upon the closing of the private placement, Enlivex will adopt the world’s first RAIN prediction markets token digital asset treasury strategy, via RAIN token accumulation. - RAIN is a fully decentralized predictions and options protocol that redefines predictive market ecosystems and provides a powerful platform for on-chain market creation - built for transparency, automation, and community participation. - Mr. Matteo Renzi, former Prime Minister of Italy, will be appointed to the Enlivex Board of Directors following closing of the private placement. - Enlivex to continue clinical development of Allocetra™, a potentially game-changing knee osteoarthritis therapeutic, a growing market with significant unmet medical need. - Price per share of $1.00, representing a premium of 11.5% from previous closing price. NES-ZIONA, Israel, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, “Enlivex” or “the Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) for the purchase and sale of 212,000,000 ordinary shares (or ordinary share equivalents in lieu thereof) at a price of $1.00 per share, representing a premium of 11.5% from the closing price of the stock on November 21, 2025, for expected aggregate gross proceeds of approximately $212,000,000 (funded in a combination of $USD and USDT), before deducting placement agent fees and other offering expenses (the “Transaction”). Enlivex intends to use net proceeds from the PIPE to implement the first RAIN prediction markets token treasury strategy, while continuing its focus on the Company’s core business operations. RAIN is a fully decentralized predictions and options protocol built on the Arbitrum network. The protocol is fully permissionless, allowing anyone to create and trade custom options on any market. Market outcomes can be AI-resolved, and the platform is governed by the RAIN token, which features a built-in, deflationary Buyback & Burn mechanism. Designed to be the “Uniswap” of prediction markets, RAIN is a protocol where anyone, from anywhere, can create any type of market, whether it's public or private, in any language. “With the recent institutional interest in leading prediction markets companies – $2 billion investment by NYSE’s parent company in Polymarket, and Kalshi’s $300 million financing round led by Andreessen Horowitz (a16z) and Sequoia Capital – it appears that this industry is maturing and has strong growth potential. We believe that following the closing of this transaction and the implementation of the RAIN treasury strategy, Enlivex will become the first U.S.-traded public company to provide investors with an exposure to prediction markets, one of the fastest growing sectors in the crypto industry”, stated Shai Novik, Chairman of the Board of Directors of Enlivex. “RAIN’s decentralized protocol uses blockchain technology to let participants trade on expectations of future events, and we believe it will become a dominant force in this expanding market segment.” Mr. Novik added, “Alongside managing the RAIN treasury portfolio, Enlivex will continue its existing operations focused on late-stage clinical development of Allocetra™, a novel therapy designed to treat the joint disease osteoarthritis. Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. I would like to welcome Mr. Matteo Renzi to the Board of Directors of Enlivex and am looking forward to working together with Mr. Renzi to build shareholder value for Enlivex shareholders.” The closing of the Transaction is expected to occur on or before November 25, 2025 (the “Closing”), subject to the satisfaction of customary closing conditions. BTIG is serving as the sole placement agent and exclusive financial advisor for the Transaction. Greenberg Traurig, P.A. and FISCHER (FBC & Co.) serve as legal counsels to Enlivex, and DLA Piper and Gornitzky & Co. serve as legal counsels to BTIG. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful. ABOUT ENLIVEX Enlivex will be the first publicly-listed company to develop a treasury strategy centered on RAIN, which will serve as the primary treasury reserve asset of the Company. In adopting its new treasury policy, Enlivex intends to provide investors with exposure to RAIN and to advocate for its role as digital capital. In addition, Enlivex has an operating business focused on late-stage clinical development of Allocetra™, a novel therapy designed to treat the joint disease osteoarthritis. Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. To the Company’s knowledge, there are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint. 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” and other words of similar meaning, including statements relating to the anticipated benefits and timing of the completion of the proposed Transaction and related transactions, the intended use of proceeds from the Transaction, the assets to be held by the Company, the expected future market, price and liquidity of the digital assets the Company acquires, the macro and political conditions surrounding digital assets, the Company’s plan for value creation and strategic advantages, market size and growth opportunities, regulatory conditions, competitive position and the interest of other corporations in similar business strategies, technological and market trends, future financial condition and performance and the expected financial impacts of the proposed Transaction described herein. 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 the proposed Transaction described herein may not be completed in a timely manner or at all; failure to realize the anticipated benefits of the Transaction and the proposed 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 of RAIN and other cryptocurrencies; the risk that the price of the Company’s ordinary shares may be highly correlated to the price of the digital assets that it holds; risks related to increased competition in the industries in which the Company does and will operate; 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, as well as 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, CFOEnlivex Therapeutics, Ltd.shachar@enlivex.com INVESTOR RELATIONS CONTACT KCSA Strategic CommunicationsJack PerkinsEnlivex@KCSA.com

Nes-Ziona, Israel, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. ( Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra™ trial (ENX-CL-05-001) in patients with moderate to severe knee osteoarthritis (OA). The six-month follow-up has now been completed for all patients. The results re-affirm the three-month data reported previously and substantiate the identification of an age-related primary OA responder population. Summary of the 6-month Topline Data On August 18, 2025, Enlivex announced the 3-month topline data, reporting that Allocetra™ demonstrated, in the primary age group (60+), substantial reduction in pain and improvement in function across multiple efficacy endpoints that were evaluated, compared to placebo. The analysis revealed a robust positive correlation between patients’ age and the magnitude of the clinical effect and its statistical significance. At 6 months, Allocetra™ continued to demonstrate substantial and durable reduction in pain and improvement in function across multiple efficacy endpoints evaluated in the same primary age group (60+), as compared to placebo. These findings are consistent with the 3-month observations, as well as the robust positive correlation between patients’ age and the magnitude of the clinical effect and its statistical significance. Allocetra™ demonstrated a clinically meaningful improvement in pain and function, a composite endpoint which we expect will be a key endpoint in the follow-up pivotal studies, reaching statistical significance at 3-month at age 60+ (-26.8 points in the AllocetraTM treated group versus -13.4 points in the placebo group, corresponding to 99% improvement over the placebo group (scale 0-100; p=0.008), and at 6-month at age 61+ (-27.8 points in the AllocetraTM treated group versus -15.5 points in the placebo group corresponding to 80% improvement over the control group (scale 0-100; p=0.02).) Allocetra™ continued to demonstrate a favorable safety profile through the six-month follow-up, consistent with the previously reported three-month data. Professor Philip Conaghan, MBBS, PhD, FRACP, FRCP, is an internationally renowned leader in osteoarthritis and musculoskeletal imaging, and the Consultant Rheumatologist and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan has authored more than 700 publications and chaired multiple global guidelines and trial initiatives and is a member of the Clinical Advisory Board of Enlivex. Prof. Conaghan commented “The toll of knee osteoarthritis continues to grow with the increasing burden of aging and obesity, and subsequently the need for effective therapies is becoming a major need undertaking. With the understanding that inflammatory mediators play a central role in the progression of knee pain and dysfunction, new treatment strategies can be proposed. I am encouraged by the results demonstrated in the study so far and continue to follow the clinical development of Allocetra™ as an immune modulating agent that could potentially pioneer a new therapeutic approach.” Oren Hershkovitz, Ph.D., CEO of Enlivex, stated: “We believe the six-month results provide strong evidence that Allocetra™ delivers a durable and clinically meaningful benefit for patients with age-related primary knee osteoarthritis. A single treatment cycle producing at least six months of sustained efficacy represents not only a potentially transformative therapeutic option for patients but also supports a compelling and scalable commercial opportunity for Enlivex.” Einat Galamidi, M.D., CMO of Enlivex, added: “We are highly encouraged by the durable clinical improvements observed in this patient population. These results pave the way for our upcoming Phase IIb trial evaluating Allocetra™ in age-related primary knee osteoarthritis. We plan to initiate this study in the first half of 2026 and are committed to advancing Allocetra™ as a potential novel treatment to improve the quality of life for millions of patients affected by knee osteoarthritis.” In-depth analysis of the 6-month results is provided in a separate presentation, available as part of the Companiy’s SEC filings and can be downloaded from its website. About ENX-CL-05-001 ENX-CL-05-001 is a multi-center Phase I/II clinical trial consisted 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 or the subsequent Phase IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol was designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial’s key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment. ABOUT KNEE OSTEOARTHRITIS Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. For more information, visit https://enlivex.com/. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACT Shachar Shlosberger, CFO Enlivex Therapeutics, Ltd. shachar@enlivexpharm.com INVESTOR RELATIONS CONTACT IR Contact: KCSA Strategic Communications Jack Perkins Enlivex@KCSA.com