Temporomandibular Joint Disorders

NESS-ZIONA, Israel I April 03, 2025 I Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis. The study will be conducted by the Rheumatology Unit at Sheba Medical Center in collaboration with the Department of Oral and Maxillofacial Surgery at Sheba Medical Center. Notably, Sheba Medical Center was recently ranked among the top 10 hospitals in the world by Newsweek . Dr. Einat Galamidi, CMO of Enlivex, commented, “This study will provide a preliminary evaluation of the safety and potential effect of Allocetra TM for the treatment of TMJ osteoarthritis, which affects a joint that is critical for daily function. We are pleased to report that the injection of Alloctera TM into the first patient’s TMJ was successfully completed with no complications.” The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for TMJ osteoarthritis. The trial’s primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and efficacy endpoints will assess changes from baseline in TMJ pain, joint functionality, and other disease parameters for up to 12 months following administration of Allocetra™. ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents. ABOUT TEMPOROMANDIBULAR JOINT (TMJ) OSTEOARTHRITIS TMJ disorders are the second most common musculoskeletal condition affecting five to 12% of the population globally, with an annual health cost estimated at $4 billion 1 . Osteoarthritis of the TMJ is the most common form of arthritis in the TMJ, causing pain and stiffness in the jaw. It may become difficult to chew. TMJ osteoarthritis is a degenerative disease of the joint, which culminates in the progressive destruction of all soft and hard tissue components of the TMJ. For patients who present in early adulthood with severe clinical symptoms and catastrophic radiographic changes, there are significant implications for management, including the potential need for early total joint replacement. There are currently no effective long-term treatments for this disease 2 . 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 conditions. For more information, visit http://www.enlivex.com . 1 Bianchi et al., Sci Rep 2020 2 Delpachitra et al., British Journal of Oral and Maxillofacial Surgery 60 (2022) SOURCE: Enlivex

Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to 12% of the population globallyTMJ causes pain and stiffness in the jaw, making it difficult to chewTMJ osteoarthritis currently has no long-term effective treatments Ness-Ziona, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis. The study will be conducted by the Rheumatology Unit at Sheba Medical Center in collaboration with the Department of Oral and Maxillofacial Surgery at Sheba Medical Center. Notably, Sheba Medical Center was recently ranked among the top 10 hospitals in the world by Newsweek. Dr. Einat Galamidi, CMO of Enlivex, commented, “This study will provide a preliminary evaluation of the safety and potential effect of AllocetraTM for the treatment of TMJ osteoarthritis, which affects a joint that is critical for daily function. We are pleased to report that the injection of AllocteraTM into the first patient’s TMJ was successfully completed with no complications.” The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for TMJ osteoarthritis. The trial’s primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and efficacy endpoints will assess changes from baseline in TMJ pain, joint functionality, and other disease parameters for up to 12 months following administration of Allocetra™. ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents. ABOUT TEMPOROMANDIBULAR JOINT (TMJ) OSTEOARTHRITIS TMJ disorders are the second most common musculoskeletal condition affecting five to 12% of the population globally, with an annual health cost estimated at $4 billion1. Osteoarthritis of the TMJ is the most common form of arthritis in the TMJ, causing pain and stiffness in the jaw. It may become difficult to chew. TMJ osteoarthritis is a degenerative disease of the joint, which culminates in the progressive destruction of all soft and hard tissue components of the TMJ. For patients who present in early adulthood with severe clinical symptoms and catastrophic radiographic changes, there are significant implications for management, including the potential need for early total joint replacement. There are currently no effective long-term treatments for this disease2. 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 conditions. For more information, visit http://www.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, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com INVESTOR RELATIONS CONTACT Dave Gentry, CEORedChip Companies Inc.1-407-644-4256ENLV@redchip.com ____________________________________1 Bianchi et al., Sci Rep 2020 2 Delpachitra et al., British Journal of Oral and Maxillofacial Surgery 60 (2022)

Dental anxiety and mistrust are among the leading reasons individuals avoid dental treatment. Approximately 36% of people in the U.S. have a fear of dental care, with 12% experiencing extreme fear. This leads to missed appointments, neglected tooth pain, and poor oral health. Fortunately, emerging dental technologies are significantly improving patient care and outcomes, helping to reduce the prevalence of anxiety and mistrust associated with dental treatments. The prevalence and impact of dental anxiety Due to its impact on overall health and quality of life, dental anxiety is categorized as a major public health concern. Each year, 40 million Americans avoid the dentist because of anxiety, resulting in serious consequences for their oral health. Individuals experiencing dental anxiety are more likely to have at least one missing or decaying tooth and are at higher risk of gum disease and early tooth loss. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The fear of dental treatment affects a patient’s overall quality of life. One in three Americans aged 50-64 feel ashamed about the state of their teeth, and 38% report that dental conditions have caused them pain, difficulties with eating, or interference with their daily lives. With one in six individuals over the age of 65 missing all their teeth, it is apparent that improvements in the dental industry are urgently needed. Establishing trust and understanding patients’ fears is critical for providing relief. Doctors can reduce mistrust by walking patients through the process, discussing their concerns, and presenting potential solutions. This allows patients to visualize and participate in their dental treatment. In addition to thorough communication, advancements in dental technology have revolutionized the patient experience. Tech innovations are revolutionizing the dental industry Innovations such as intraoral digital scanners and advanced radiology tools can significantly minimize dental anxiety. For example, intraoral digital scanners eliminate the discomfort associated with traditional dental mold trays, which are often used to capture replicas of patient’s mouths for implants, braces, and orthodontic procedures. These molds can be uncomfortable, and patients with fragile or loose teeth may worry that the mold could dislodge their teeth. Intraoral digital scanners offer a convenient alternative for patients with vulnerable teeth. The non-invasive scanner is a small, handheld device that is placed in the patient’s mouth and carefully moved across their teeth and gums to create a fully digital and more accurate image of the mouth. Dentists can also utilize extraoral radiology, including cone beam CT scans, to reduce the need for excessive sensors placed in the mouth. These tools enable patients to visualize every step of their treatment, providing security and confidence. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Virtual smile design technology elevates visualization by allowing patients to see an image of what their appearance could look like following treatment. The process involves taking images of a patient’s teeth and smile and manipulating the data to design an improved smile. Patients can see an accurate representation of their future results, which incorporates their tooth shape, size, color and alignment. Additionally, the integration of 3D printers significantly improves efficiency for both providers and patents, by enabling dental providers to manufacture essential treatment components in-office. This technology not only streamlines the workflow for providers, but also aids the timeliness of patient solutions.This not only showcases the dental provider’s expertise but also helps patients make informed decisions with clear expectations. These innovations contribute toward creating a safer and more comfortable environment while reducing possible triggers. Triggers can include the prolonged time patients spend with their mouth open, which may cause pain and discomfort for individuals with trismus or limited jaw mobility. Trismus can result from TMJ disorders, trauma, muscle or nerve dysfunction, or oral cancer treatments. Other triggers diminished by technology include lack of knowledge about treatment details and uncertainty around results. Enhancing patient care The integration of the latest technologies improves diagnostic quality and accelerates treatment solutions, decreasing the time patients spend in discomfort or pain due to dental issues. Modern oral scanning technology creates state-of-the-art imagery of the patient’s mouth, providing a detailed view of the condition of the teeth to better inform treatment plans. Improved reliability and consistency in diagnosing patients support dynamic, individualized treatment plans. The adoption of patient-centric technologies enriches dental treatments, making them more personalized and tailored to patient needs. Dental providers can adjust their approaches based on individual concerns, dental history, and oral health demands. Cutting-edge materials used in treatments, such as dental implants, are customized to the exact specifications of a patient’s mouth, optimizing comfort and improving patient outcomes. Workflows are now efficiently streamlined through the integration of these technologies, contributing to expedited results. Today’s patients are looking to avoid healthcare treatments that require multiple visits. In a survey conducted by Futuredontics, 30% of respondents said convenience is the top reason for selecting their dentist. While dental implants typically require 3-10 appointments, innovations in modeling synthesize dental treatments, providing access to oral surgeons, prosthodontists, and dental labs under one roof. This model minimizes appointments and reduces the time patients spend in the chair, allowing them to feel more at ease with treatment decisions and boosting their confidence in overcoming their fears. For dental professionals seeking the latest technology for their patient base, be sure to understand what exactly you need and properly vet the software or hardware before implementation. It’s important to understand how this will add value to your patients and staff. As healthcare providers, we are obligated to strive for the highest quality of care, and with the integration of the right advanced technologies, we can help alleviate dental anxiety and mistrust in the industry. Picture: Nastasic, Getty Images Theresa WangDr. Theresa Wang is the chief clinical & development officer at ClearChoice Dental Implant Centers. She received her doctorate degree at the University of Illinois at Chicago. She then completed advanced training and certification in prosthodontics at the University of North Carolina at Chapel Hill, where she concurrently earned a Masters degree in prosthodontics and completed and published clinical research on dental implants. She has extensive training with the latest dental technologies and dental materials. Dr. Wang also holds an Illinois license as a Dental Specialist in Prosthodontics. By combining her knowledge of the most current dental technologies with her particular aesthetic eye, she is equipped to design smiles that have substantial effects on her patients’ lives.This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.