Enlivex Therapeutics Ltd - ENLV STOCK NEWS

Enlivex Therapeutics (NASDAQ:ENLV) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on January 11, 2025, at 7 p.m. ET. CEO Oren Hershkovitz will provide a corporate update focusing on their Allocetra™ platform, a universal, off-the-shelf cell therapy designed to reprogram macrophages.

The company has achieved significant progress with promising Phase I/II clinical trial results in multiple indications, including knee osteoarthritis and psoriatic arthritis. In 2024, Enlivex initiated a multi-country, randomized trial evaluating Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis, with key data expected by Q3 2025.

Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to begin a Phase I trial evaluating Allocetra™ in patients with temporomandibular joint (TMJ) osteoarthritis. The investigator-initiated trial will be conducted at Sheba Medical Center, recently ranked among the world's top 10 hospitals by Newsweek.

The study aims to recruit six patients who haven't responded adequately to conventional TMJ osteoarthritis treatments. The trial will assess safety through monitoring adverse events, while efficacy endpoints will evaluate changes in TMJ pain, joint functionality, and other disease parameters for up to 12 months post-treatment.

Enlivex Therapeutics announced positive interim efficacy data from its Phase I/II Allocetra™ trial for moderate to severe knee osteoarthritis. The Phase I stage showed statistically significant results (p-value < 0.0007, n=12) with marked improvements in key efficacy endpoints. The treatment demonstrated a 50% reduction in average knee joint pain, 42% improvement in knee joint function, and 37% reduction in knee joint stiffness after three months. Among participants, 83% were responders to Allocetra™, showing >40% pain reduction from baseline. The trial is now enrolling patients for the Phase II stage, which is double-blind, randomized, and placebo-controlled.

Enlivex Therapeutics (Nasdaq: ENLV) announces an exclusive live investor webinar and Q&A session scheduled for December 3, 2024, at 11:00 a.m. ET. CEO Oren Hershkovitz will discuss the company's lead product Allocetra™, its clinical status, and planned catalysts for 2025. Allocetra™ is an off-the-shelf cell therapy that reprograms macrophages to optimal functioning state, addressing conditions like osteoarthritis, sepsis, and psoriatic arthritis. Phase I/II trials have shown promising results in these multi-billion-dollar markets. Investors can pre-submit questions to ENLV@redchip.com or participate in the live Q&A.

Enlivex Therapeutics (Nasdaq: ENLV) announced its Board of Directors has approved the purchase of up to $1 million of Bitcoin as part of its cash management strategy. The clinical-stage macrophage reprogramming immunotherapy company views Bitcoin as a strong and diversifying treasury reserve asset, citing growing demand, increased acceptance as a medium of exchange, recent Bitcoin ETF approvals, and institutional investor support. The company believes Bitcoin can serve as a potential store of value and inflation hedge against standard currencies.

Enlivex Therapeutics has initiated a Phase I clinical trial evaluating Allocetra™ in patients with psoriatic arthritis. The first patient has completed dosing and initial follow-up with no safety concerns reported. The trial aims to recruit six patients who haven't responded adequately to conventional therapies. The study will assess safety through monitoring adverse events, and measure changes in pain and disease activity for up to 12 months post-treatment. This trial complements Enlivex's ongoing osteoarthritis study, targeting high-grade inflammatory joint disease with potential market opportunities.

Enlivex Therapeutics (Nasdaq: ENLV) announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of its Allocetra™ trial for moderate to severe knee osteoarthritis. This follows the successful completion of Phase I safety run-in stage and approval from the Danish Medicines Agency. The Phase II stage is designed as a double-blind, randomized, placebo-controlled study, focusing on evaluating both safety and efficacy of Allocetra™ knee injections. The trial will assess joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Initial dosing showed no safety concerns.

Enlivex Therapeutics (Nasdaq: ENLV) has received a notice of allowance from the Japanese Patent Office for patent application 2022-512861, titled 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS'. The patent, expected to be formally issued by Q2 2025, will protect Enlivex's intellectual property rights for Allocetra™ in Japan through at least 2040. This development supports the company's global IP strategy and their efforts to develop Allocetra™ as a next-generation cell therapy for osteoarthritis, addressing an unmet medical need with current treatment options.

Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Danish Medicines Agency to initiate the Phase II stage of its Phase I/II trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. This approval follows a recommendation by the independent Data and Safety Monitoring Board (DSMB) to proceed to Phase II. The trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, and a Phase II double-blind, randomized, placebo-controlled stage.

The Phase II stage will evaluate both safety and efficacy of Allocetra™ injections into the knee, with primary measurements assessing joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Dr. Einat Galamidi, Medical Vice President of Enlivex, expressed satisfaction with Allocetra™'s safety profile following three sequential intra-articular knee injections in the first twelve patients of the Phase I stage.