Enlivex Therapeutics (ENLV) Conference Call Summary Company Overview - **Company**: Enlivex Therapeutics - **Ticker**: ENLV - **Focus**: Development of innovative therapies for inflammatory diseases, specifically targeting macrophages to treat conditions like osteoarthritis [3][15] Key Points and Arguments Phase 2a Study Results - **Study Focus**: Evaluated the efficacy and safety of Alocetra in patients with moderate to severe knee osteoarthritis [19][23] - **Market Size**: Approximately 32 million adults in the US suffer from osteoarthritis, with a current market size of $7 billion, expected to grow to $15 billion by 2030 [20][21] - **Demographics**: Prevalence of osteoarthritis increases with age, with about 40% of individuals aged 60 and above affected [22][23] - **Study Design**: Randomized, double-blind, placebo-controlled trial with 134 patients receiving either Alocetra or placebo [30][34] - **Primary Endpoint**: Safety; secondary endpoints included changes in pain and function [30][57] - **Results**: - 24% positive effect in overall pain reduction across study patients [36] - 72% effect size over placebo in primary osteoarthritis patients aged 60 and above, statistically significant [36][37] - Nearly 100% effect in function improvement across all efficacy endpoints [38] - Favorable safety profile with no serious adverse events reported [50][66] Unique Selling Proposition - **Innovative Approach**: Enlivex utilizes a novel method of reprogramming macrophages, which is distinct from other therapies in the market [15][16] - **Cost-Effectiveness**: Projected treatment cost of approximately $450, competitive with existing therapies [67][68] - **Unmet Medical Need**: Current treatments for osteoarthritis are largely ineffective, creating a significant opportunity for Alocetra [21][68] Future Plans - **Next Steps**: - Continue follow-up studies with six-month and twelve-month data expected [58][72] - Initiate Phase 2b study focusing on primary idiopathic osteoarthritis patients, targeting 75 patients per arm [55][57] - Explore partnership opportunities for further development and commercialization [60][64] Financial Position - **Cash Position**: As of March, Enlivex reported $20.6 million, with plans to utilize existing cash and explore non-dilutive funding opportunities [84] Additional Important Information - **Management Experience**: The management team has a strong background in drug development, with previous successes in the biotech industry [17][18] - **Regulatory Discussions**: Ongoing discussions with the FDA regarding the potency assay for Alocetra [80] - **Market Context**: The current landscape for osteoarthritis treatments is lacking effective solutions, positioning Alocetra as a potential leader in the market [81][84] This summary encapsulates the critical insights from the Enlivex Therapeutics conference call, highlighting the company's innovative approach, promising study results, and strategic plans for future growth.

Core Insights - Enlivex Therapeutics announced positive topline data from the Phase IIa trial of Allocetra™, showing significant improvements in knee pain and function in patients with moderate-to-severe knee osteoarthritis [1][2][3] Group 1: Clinical Trial Results - In the modified intention-to-treat population, Allocetra™ demonstrated a 24% reduction in knee pain and a 26% improvement in knee function compared to placebo [1] - For age-related primary osteoarthritis patients, Allocetra™ resulted in a 72% reduction in knee pain and a 95% improvement in knee function compared to placebo, indicating a substantial and statistically significant effect [1][2] Group 2: Safety Profile - The trial reported a favorable safety profile for Allocetra™, with no severe adverse events and only mild to moderate, transient, and treatable side effects observed in most patients [2] Group 3: Company Overview - Enlivex Therapeutics is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy aimed at reprogramming macrophages to restore immune balance [8] - The company emphasizes the significant unmet medical need in the knee osteoarthritis market, which affects over 32.5 million Americans and is projected to increase to 78 million by 2040 [6]

Core Insights - Enlivex Therapeutics Ltd. will host a webinar on August 18, 2025, to present 3-month topline results from the Phase IIa stage of its ENX-CL-05-001 trial evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis [1][2] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [5] Clinical Trial Details - The ongoing Phase IIa trial is a double-blind, randomized, placebo-controlled study assessing safety and efficacy, with endpoints measuring joint pain and function at 3, 6, and 12 months post-injection [4] - An interim analysis has been conducted to evaluate the potential benefits of expanding patient enrollment from 130 to 180, with 134 patients having completed the 3-month follow-up period [4][3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with symptomatic knee osteoarthritis being particularly prevalent, impacting 40% of men and 47% of women in their lifetimes [3]

Core Insights - Enlivex Therapeutics Ltd. will present data on its macrophage reprogramming therapy, Allocetra™, at the EULAR European Congress of Rheumatology in Barcelona from June 11-14, 2025 [1][2] - Allocetra™ aims to treat knee osteoarthritis by reprogramming macrophages to promote immune balance and reduce chronic inflammation, showing promising results in Phase I/II trials [2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, with Allocetra™ being a universal, off-the-shelf cell therapy [4] - The therapy is designed to reset non-homeostatic macrophages to a homeostatic state, which is essential for immune system rebalancing [4] Clinical Study Details - The ongoing clinical study of Allocetra™ involves patients with moderate to severe knee osteoarthritis, with all patients enrolled in the Phase II stage of the trial [2] - The company anticipates topline data from the Phase II stage to be available by August 2025 [2] Presentation Information - The poster presentation titled "Phase I/II Trial of Allocetra™ Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation" will be presented by Dr. Oren Hershkovitz and Einat Galamidi at the conference [3][6]

Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2025 AND 2024 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2025 AND 2024 INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | | Page | | --- | --- | | Condensed Consolidated Balance Sheets | F-1 | | Condensed Consolidate ...

Core Insights - Enlivex Therapeutics Ltd. has been selected to present at the Israeli BioMed 2025 Conference, focusing on its macrophage reprogramming therapy, Allocetra™, for treating inflammatory diseases [1][2] Company Overview - Enlivex is a clinical-stage company specializing in macrophage reprogramming immunotherapy, developing Allocetra™, a universal, off-the-shelf cell therapy aimed at resetting macrophages to their homeostatic state [4] Product Details - Allocetra™ is designed to address non-homeostatic macrophages, which are linked to various chronic and life-threatening diseases, by reprogramming them to restore immune balance [2][4] - The company is advancing a clinical pipeline that includes multiple Phase I/II trials for conditions such as osteoarthritis and psoriatic arthritis [3] Clinical Trial Results - Recent interim data from a six-month study in moderate knee osteoarthritis indicated a 47% reduction in pain, a 46% improvement in joint function, and a 40% decrease in stiffness [3]

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Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [5]. Clinical Trial Progress - The company has completed patient enrollment for the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, involving a total of 133 patients [1][3]. - The Phase I stage provided promising initial efficacy data, with significant improvements in key efficacy endpoints and no safety issues reported for the first 12 patients treated [2][3]. Future Expectations - Enlivex aims to release topline data from the Phase II trial, including full 3-month endpoints, by August 2025 [2][3]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [4]. - The condition leads to significant healthcare burdens, with over one million hospitalizations annually in the U.S. primarily for total joint replacement, highlighting the critical need for effective treatments [4].

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™ [1][6] - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at restoring macrophage homeostasis, which is critical for immune system balance and addressing life-threatening conditions [4][6] Clinical Trial Announcement - The first patient has been dosed in a Phase I trial to evaluate the safety, tolerability, and initial efficacy of Allocetra™ for treating temporomandibular joint (TMJ) osteoarthritis [1][3] - The trial is being conducted by the Rheumatology Unit and the Department of Oral and Maxillofacial Surgery at Sheba Medical Center, which is ranked among the top 10 hospitals globally [2] Trial Details - The trial aims to recruit six patients who have not adequately responded to conventional therapies for TMJ osteoarthritis [3] - Primary safety endpoints will measure the frequency and severity of adverse events, while efficacy endpoints will assess changes in TMJ pain, joint functionality, and other disease parameters over 12 months [3] TMJ Osteoarthritis Insights - TMJ disorders affect 5% to 12% of the global population, with an annual health cost estimated at $4 billion [5][8] - TMJ osteoarthritis is the most common form of arthritis in the TMJ, leading to pain and stiffness, and currently lacks effective long-term treatments [5][8]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [4]. Patent and Intellectual Property - The China National Intellectual Property Administration (CNIPA) has issued a notice of allowance for Enlivex's patent application number 2020800620493, which will provide intellectual property protection in China until at least 2040 for methods using Allocetra™ to treat osteoarthritis [1]. - The company anticipates that the patent will be officially issued in the first half of 2025 [1]. Clinical Trial Results - Enlivex reported positive interim data from a Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, showing a statistically significant average pain reduction of 47.0% (P=0.0001) compared to baseline [6]. - The trial also indicated a 46% improvement in joint function and a 40% improvement in joint stiffness, with 83% of patients still considered responders after six months [6]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [3]. - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for total joint replacement, highlighting the critical need for effective treatments [3].