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Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

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Enlivex Therapeutics Ltd. (NASDAQ: ENLV) is an Israel-based clinical-stage immunotherapy company focused on developing innovative allogeneic drugs to rebalance the immune system. The company's flagship product candidate, Allocetra™, is under development for multiple severe and critical conditions.

Allocetra™ is currently in a Phase IIB clinical trial targeting patients with severe sepsis, a life-threatening condition caused by the body's response to infection. Additionally, it is being investigated in a Phase II clinical trial for the treatment of COVID-19 patients with severe and critical conditions. The company is also exploring Allocetra™ in a Phase IIA trial for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplants (HSCT).

Enlivex is advancing Allocetra™ as a potential treatment for complications associated with bone marrow transplants, acute multiple organ failure, and as a combination therapy with various anti-cancer treatments to enhance efficacy. The immunotherapy works by reprogramming macrophages to their homeostatic state, thus rebalancing the immune system.

Recently, the Israeli Ministry of Health authorized a new trial for Allocetra™ targeting osteoarthritis, a chronic inflammatory condition affecting millions worldwide. This multi-country, double-blind, placebo-controlled Phase I/II trial aims to evaluate the safety and efficacy of Allocetra™ injections in knee osteoarthritis patients.

The company has shown promising results in its Phase II study of Allocetra™ in sepsis patients, demonstrating a favorable safety profile and potential effectiveness. With approvals from the Danish Medicines Agency and other international regulators, Enlivex is extending its clinical trials across multiple countries to further evaluate Allocetra™'s broad therapeutic potential.

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Enlivex Therapeutics Ltd. announced the issuance of U.S. Patent Nos. 11,304,976 and 11,318,163, securing intellectual property protection for treating sepsis with Allocetra™ until at least 2036. CEO Oren Hershkovitz emphasized that these patents strengthen their sepsis program, particularly for pneumonia, urinary, and biliary infections. The company is advancing its Phase II trial of Allocetra™, designed to reprogram macrophages and address life-threatening conditions. Enlivex aims to expand its patent portfolio globally.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV)?

The current stock price of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV) is $1.24 as of December 20, 2024.

What is the market cap of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV)?

The market cap of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV) is approximately 25.8M.

What is Enlivex Therapeutics Ltd.?

Enlivex Therapeutics Ltd. is an Israel-based clinical-stage immunotherapy company developing allogeneic drugs to rebalance the immune system.

What is Allocetra™?

Allocetra™ is Enlivex's flagship immunotherapy candidate, designed to reprogram macrophages and rebalance the immune system. It is being tested for severe sepsis, COVID-19, GVHD, and more.

What clinical trials are ongoing for Allocetra™?

Allocetra™ is in Phase IIB trials for severe sepsis, Phase II for COVID-19, and Phase IIA for GVHD prevention. Additionally, it's being tested in a Phase I/II trial for knee osteoarthritis.

What recent achievements has Enlivex made?

Enlivex received approval from the Israeli Ministry of Health for a new osteoarthritis trial and announced positive Phase II study results for Allocetra™ in sepsis patients.

What is the significance of Allocetra™ in osteoarthritis treatment?

Allocetra™ is being evaluated for its potential to reprogram macrophages and address the inflammatory causes of osteoarthritis, offering a novel treatment option.

How does Allocetra™ work?

Allocetra™ works by restoring macrophages to their homeostatic state, helping to rebalance the immune system and treat various severe and chronic conditions.

What are the benefits of Enlivex's therapy?

Enlivex's Allocetra™ offers a potential new mechanism of action for treating life-threatening and debilitating conditions by modulating the immune system.

What is the company's financial condition?

Enlivex recently closed a $5 million registered direct offering, indicating strong financial support for its ongoing and future clinical trials.

What are the future plans for Allocetra™?

Enlivex plans to continue expanding its clinical trials for Allocetra™, including potential larger studies for sepsis and ongoing trials for knee osteoarthritis.

Where can I find more information about Enlivex?

For more details, visit Enlivex's official website at http://www.enlivex.com.

Enlivex Therapeutics Ltd. Ordinary Shares

Nasdaq:ENLV

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