Enlivex Therapeutics Ltd Stock Price, News & Analysis

Enlivex Therapeutics (Nasdaq: ENLV) announced positive results from the Phase I safety run-in stage of its Phase I/II clinical trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. The independent Data and Safety Monitoring Board (DSMB) recommended proceeding to the Phase II stage after reviewing the safety data. Key points include:

1. No serious adverse reactions reported during or after treatment
2. DSMB confirmed Allocetra™'s safety profile allows progression to Phase II
3. Phase II will use the highest dose tested in Phase I
4. The trial will involve up to 160 patients
5. Phase II is a double-blind, randomized, placebo-controlled study
6. Primary measurements will assess joint pain and function at 3, 6, and 12 months post-treatment

RedChip Companies will air interviews with GreenPower Motor Company Inc. (Nasdaq:GP) and Enlivex Therapeutics on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on August 31, 2024, at 7 p.m. ET. The show reaches an estimated 73 million homes across the U.S.

In his interview, GreenPower's CEO Fraser Atkinson provides a corporate update. GreenPower manufactures all-electric, zero-emission medium and heavy-duty vehicles for various markets. The company has delivered over 700 vehicles to date and maintains a significant order book. GreenPower's competitive positioning and market dynamics suggest potential for sustained growth in the EV industry.

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.

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.

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.