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Enlivex Ltd. develops quality longevity therapeutics and operates a prediction markets treasury alongside its clinical programs. The company’s news centers on Allocetra™, a clinical-stage immunotherapy for inflammatory conditions associated with aging, with a primary focus on moderate-to-severe age-related knee osteoarthritis.
Recurring updates also cover the RAIN token and Rain protocol, including digital asset treasury holdings, exchange listings, decentralized prediction-market infrastructure, tokenized exposure to Enlivex ordinary shares, financial results affected by treasury assets, financing activity, and share repurchase authorization.
Enlivex Therapeutics (Nasdaq: ENLV) announced the acceptance of an abstract for a poster presentation at the 2022 ASCO Annual Meeting, scheduled for June 3-7, 2022, at the McCormick Place in Chicago.
The poster, titled "In-vivo reprogramming macrophages and dendritic cells with Allocetra-OTS", covers successful antitumor therapy. The presentation will take place on June 5, 2022, between 8:00 AM and 11:00 AM CDT.
Allocetra™ aims to restore macrophage homeostasis, presenting a potential new immunotherapeutic approach for treating various diseases.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the completion of the frozen formulation of Allocetra™ in Q1 2022, twelve months ahead of schedule. This reformulation enhances shelf-life and manufacturing scalability, potentially lowering costs and increasing profitability. The company will integrate the frozen formulation into its ongoing Phase II sepsis trial, slightly delaying the trial's completion by 6-8 months but expediting eventual regulatory approval. Enlivex is deprioritizing its COVID-19 program to focus on sepsis and oncology, extending its cash runway to Q3 2024.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of Israeli Patent Number 255119 for 'Therapeutic Pooled Blood Apoptotic Cell Preparations.' This patent grants intellectual property protection in Israel until at least 2037, covering the use of pooled donor cells in their Allocetra product. CEO Oren Hershkovitz emphasized the importance of a strong patent portfolio in their corporate strategy. Enlivex is developing Allocetra as an off-the-shelf cell therapy aimed at reprogramming macrophages to treat severe diseases, addressing critical unmet medical needs.
Enlivex Therapeutics has appointed Dr. Einat Galamidi as Vice President, Medical. Dr. Galamidi brings a decade of clinical development experience from Gamida Cell, where she led the development of omidubicel, a cell therapy for blood cancers. This therapy has recently initiated a Biologics License Application process with the FDA. Dr. Galamidi aims to leverage her expertise in advancing Enlivex's Allocetra program, which targets sepsis and COVID-19, among other conditions, to restore macrophage homeostasis and address unmet medical needs.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced participation in the 11th Annual LifeSci Partners Corporate Access Event from January 5-7, 2022. Management will engage in a panel discussion titled "Innovative Approaches to Cell Therapy for Oncology" on January 7 at 8:30 AM ET. The event aims to highlight innovative biotechnology and therapeutic advancements, focusing on unmet medical needs in oncology. Enlivex is advancing Allocetra™, a universal cell therapy designed to reprogram macrophages, targeting serious conditions like solid cancers and sepsis, aiming to restore immune balance.
Enlivex Therapeutics Ltd. announced that Greece’s National Organization of Medicines has approved the expansion of its Phase IIb trial for AllocetraTM in severe COVID-19 patients to additional sites. The trial aims to enroll up to 152 patients and assess the drug's safety and efficacy alongside standard treatment. Previously reported trials indicated a 0% mortality rate and a 90.5% recovery rate in severe cases. Top-line data is anticipated in late 2022 or Q1 2023. The company aims to expand its clinical trials throughout Europe.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its Phase II trial for AllocetraTM in pneumonia-associated sepsis has received approval for expansion into Greece. The trial, already active in Israel and Spain, aims to enroll 120 to 160 patients across four cohorts, assessing safety and efficacy over a 28-day follow-up. Previous Phase Ib results indicated a positive safety profile and improved clinical outcomes. Interim results are expected in the first half of 2022, with top-line data anticipated by year-end 2022.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the U.S. Patent and Trademark Office granted a notice of allowance for a new patent covering AllocetraTM, aimed at treating sepsis patients. The patent is expected to be issued in early 2022, extending intellectual property protection until at least 2036. Enlivex is conducting a Phase II trial of AllocetraTM in pneumonia-associated sepsis, with interim results anticipated mid-2022 and top-line data by year-end 2022. Additional programs target COVID-19 and solid tumors.
Enlivex Therapeutics announced several significant advancements as of November 22, 2021. They have initiated dosing in a Phase IIb trial for AllocetraTM in severe COVID-19 patients and received authorization to expand trials into Spain. A new cGMP manufacturing facility is currently in the design phase to support future needs. Financially, for Q3 2021, Enlivex reported a net loss of $3.424 million, increasing from $2.125 million year-over-year, while holding $87.6 million in cash and equivalents, sufficient to fund operations through 2023.
Enlivex Therapeutics has received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to expand its Phase IIb trial of Allocetra in treating severe and critical COVID-19 patients with ARDS to Spain. The trial aims to enroll up to 152 patients and assess safety and efficacy against standard treatment. Previous trials reported a 0% mortality rate and 90.5% recovery in treated patients. CEO Oren Hershkovitz highlighted the importance of this expansion for their regulatory strategy, reinforcing the potential of Allocetra across various conditions.