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Enlivex Therapeutics Ltd. - ENLV STOCK NEWS

Welcome to our dedicated page for Enlivex Therapeutics Ltd. news (Ticker: ENLV), a resource for investors and traders seeking the latest updates and insights on Enlivex Therapeutics Ltd. stock.

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 (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase I clinical trial for Allocetra™ in patients with psoriatic arthritis. The trial aims to evaluate the safety and tolerability of Allocetra™ when injected into an affected joint. It plans to recruit six patients who have not responded adequately to conventional therapies.

The primary endpoint will assess the frequency and severity of adverse events, while secondary endpoints will measure changes in pain and disease activity for up to 12 months post-administration. This marks the first study of Allocetra™ in psoriatic arthritis, a chronic inflammatory condition affecting up to 30% of people with psoriasis. CEO Oren Hershkovitz expressed optimism about developing a potentially effective treatment option for patients with alternatives.

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RedChip Companies will air interviews with Enlivex Therapeutics (Nasdaq:ENLV) and Biotricity, Inc. (Nasdaq:BTCY) on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on July 20, 2024, at 7 p.m. ET. Oren Hershkovitz, Ph.D., CEO of Enlivex Therapeutics, will provide a corporate update on their clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Allocetra™ has the potential to address life-threatening and debilitating unmet medical needs in conditions like osteoarthritis and sepsis.

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Enlivex Therapeutics announced the dosing of the first patient in a Phase I/II clinical trial evaluating AllocetraTM for thumb osteoarthritis. This condition, affecting millions, currently has no FDA-approved therapies. The trial, involving up to 46 patients, is divided into two stages: an open-label dose escalation phase to assess safety and tolerability, followed by a randomized, placebo-controlled stage. The primary endpoint is the frequency and severity of adverse events, while efficacy will be measured through changes in pain and function over 12 months. CEO Oren Hershkovitz highlighted the swift enrollment and successful dosing of the first patient.

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Enlivex Therapeutics invites investors to a webinar on June 25, 2024, at 4:15 p.m. ET, hosted by RedChip Companies. The event will feature CEO Dr. Oren Hershkovitz, who will discuss Allocetra™, the company's leading product candidate, and share positive interim data from a Phase I/II trial in knee osteoarthritis showing reduced pain and a favorable safety profile. Updates on various clinical programs, expected milestones, and the company's financial status following a recent direct offering will also be presented. The event will include a live Q&A session. Register at https://redchip.zoom.us/webinar/register/WN_lwhHqyYNTJG7uIYzNc0tHA#/registration.

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Enlivex Therapeutics released positive interim data from a Phase I/II trial of AllocetraTM for end-stage knee osteoarthritis. The trial involved nine patients who received a single injection of AllocetraTM. At three months, the results showed a 64% average reduction in pain, with 33% of patients experiencing complete pain relief. Notably, 89% of patients avoided knee replacement surgery. No severe adverse events were reported. The trial continues to recruit with a goal of 18 patients, assessing safety and pain relief up to 12 months post-injection.

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Enlivex Therapeutics (Nasdaq: ENLV) has received regulatory approval from the Israeli Ministry of Health to initiate a Phase I/II trial of Allocetra™ for thumb osteoarthritis. This is the first study of Allocetra™ in thumb osteoarthritis, following previous studies in knee osteoarthritis. The trial will be led by Dr. Amir Oron and aims to evaluate the safety, efficacy, and tolerability of Allocetra™ in up to 46 patients who have failed conventional therapies. The trial consists of two stages: an open-label dose escalation phase and a double-blind, placebo-controlled phase. The primary endpoints will measure safety and efficacy over 12 months. Enlivex aims to expand its osteoarthritis clinical programs into additional joints.

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Enlivex Therapeutics announced the closing of a $15 million registered direct offering. This includes the sale of 3,571,429 ordinary shares and warrants to a single healthcare-focused institutional investor at $1.40 per share. The gross proceeds amount to $5.0 million initially, with potential additional proceeds of $10.0 million if the warrants are fully exercised. The funds will be used for working capital and corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The Series A and B warrants have specific expiration terms based on clinical milestone achievements of Enlivex's Allocetra™ for knee osteoarthritis.

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Enlivex Therapeutics (Nasdaq: ENLV) announced a $15 million registered direct offering with a healthcare-focused institutional investor.

The deal includes $5 million upfront for 3,571,429 ordinary shares at $1.40 per share and associated clinical milestone-linked warrants. The Series A warrants expire 18 months after issuance or 60 days post-publication of positive topline results from the ENX-CL-05-001 trial for Allocetra in knee osteoarthritis. Series B warrants expire 5.5 years after issuance or 60 days post-FDA filing for Allocetra's osteoarthritis indication.

Gross proceeds could total $10 million if all warrants are exercised. The offering closes around May 29, 2024, with H.C. Wainwright & Co. as the placement agent.

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Enlivex Therapeutics (Nasdaq: ENLV) CEO, Oren Hershkovitz, updates shareholders on the progress of AllocetraTM, a macrophage reprogramming immunotherapy drug. The company released positive top-line data from a Phase II trial in patients with sepsis and demonstrated the potential effectiveness of AllocetraTM in high-risk urinary tract infection patients, along with a favorable safety profile. Enlivex sees a significant market opportunity in sepsis and osteoarthritis, believing each segment could represent a multi-billion dollar commercial chance. The company also began a Phase I/II trial for knee osteoarthritis patients. Enlivex is optimistic about the future impact of AllocetraTM and the potential to revolutionize medical treatment.

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Enlivex announces dosing of first two patients in its randomized, controlled Phase I/II trial evaluating Allocetra™ in patients with knee osteoarthritis. The trial aims to assess the safety and efficacy of Allocetra™ injections in up to 160 patients with moderate to severe knee osteoarthritis.
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FAQ

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.

Nasdaq:ENLV

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