Welcome to our dedicated page for Enlivex Therapeutics news (Ticker: ENLV), a resource for investors and traders seeking the latest updates and insights on Enlivex Therapeutics stock.
Enlivex Therapeutics Ltd (ENLV) is a clinical-stage biopharmaceutical company pioneering macrophage-reprogramming therapies through its lead candidate Allocetra. This page provides investors and researchers with timely updates on clinical trials, regulatory milestones, and strategic developments across its pipeline targeting immune dysregulation.
Access primary-source ENLV news including clinical trial results, research collaborations, and regulatory filings related to Allocetra's development in sepsis, osteoarthritis, and autoimmune conditions. Our curated news collection enables efficient tracking of the company's progress in creating off-the-shelf cell therapies designed to restore immune homeostasis.
Key updates include advancements in Phase I/II trials, manufacturing partnerships, and peer-reviewed data publications. Bookmark this page for direct access to ENLV's official press releases and objective third-party analysis of their innovative approach to immune rebalancing therapies.
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.
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.
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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