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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.
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.
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.
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.
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.
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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