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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 Ltd. (NASDAQ: ENLV) announced a partial exercise of its bought deal offering, resulting in the purchase of 268,205 ordinary shares at $20.00 each, generating approximately $51.3 million in gross proceeds. The funds will support clinical, regulatory, manufacturing, and R&D activities, along with potential acquisitions. The offering was conducted under an effective shelf registration statement. H.C. Wainwright & Co. served as the book-running manager. The company develops AllocetraTM, an innovative cell therapy aimed at reprogramming macrophages for better immune response.
Enlivex Therapeutics announced the issuance of U.S. Patent No. 10,927,343 for AllocetraTM, its macrophage reprogramming immunotherapy. This patent enhances intellectual property protection for treating autoimmune and inflammatory diseases, including Crohn's disease and ulcerative colitis. While focusing on critical diseases like sepsis and COVID-19, preclinical data suggest AllocetraTM may provide immune rebalancing for unmet medical needs. This development aims to establish a novel therapy mechanism targeting life-threatening conditions.
Enlivex Therapeutics (NASDAQ: ENLV) announced the closure of a public offering of 2,296,107 ordinary shares priced at $20.00 each, generating approximately $45.92 million in gross proceeds. The offering was managed by H.C. Wainwright & Co., which also received a 30-day option to purchase an additional 344,416 shares. Enlivex plans to allocate the net proceeds towards clinical, regulatory, and research activities, as well as potential acquisitions. The company operates under a shelf registration statement with the SEC.
Enlivex Therapeutics (NASDAQ: ENLV) announced an increase in its public offering to 2,296,107 ordinary shares, priced at $20.00 each, due to high demand. The offering is expected to close around February 12, 2021, pending customary closing conditions. Gross proceeds are projected to be approximately $46 million, which will be utilized for clinical, regulatory, and research activities, among other corporate purposes. H.C. Wainwright & Co. will serve as the sole book-running manager for this offering.
Enlivex Therapeutics Ltd. (NASDAQ: ENLV) announced an underwriting agreement with H.C. Wainwright & Co. to issue 500,000 ordinary shares at $20.00 each, aiming for gross proceeds of $10 million. The offering is set to close around February 12, 2021, subject to customary conditions. The underwriter also has a 30-day option for an additional 75,000 shares. Proceeds will fund clinical and regulatory activities, potential acquisitions, and general corporate purposes. This offering falls under a previously filed shelf registration statement with the SEC, providing liquidity for future endeavors.
Enlivex Therapeutics announced positive results from a Phase II clinical trial of AllocetraTM in severe and critical COVID-19 patients. The trial, which treated 16 patients, showed 0% mortality at day-28 and 87.5% recovery rate. The average hospitalization duration post-treatment was 5.3 days. Based on these outcomes, the trial was concluded early to expedite regulatory submissions. Enlivex is optimistic about AllocetraTM's potential in treating severe COVID-19 and other conditions associated with dysfunctional macrophages.
Enlivex Therapeutics (Nasdaq: ENLV) announced its participation at the H.C. Wainwright BioConnect 2021 Virtual Conference, with on-demand presentations available starting January 11, 2021, at 6:00 a.m. ET. The company's lead product, AllocetraTM, is an off-the-shelf cell therapy aimed at reprogramming macrophages to their homeostatic state, targeting diseases like solid cancers and sepsis. This innovative approach aims to address significant unmet medical needs.
Enlivex Therapeutics has reported promising results from a Phase Ib trial of AllocetraTM for severe sepsis. Comparing 10 treated patients to 37 matched controls revealed significant benefits: zero mortality in the treated group versus 27% in controls, a 58% reduction in ICU stay (4.7 vs. 11.1 days), and no increase in organ-failure among treated patients. The trial confirms AllocetraTM as a safe and potentially effective treatment option for sepsis, a condition currently lacking effective therapies. Full data is available on medRxiv.org.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced a new patent from the China National Intellectual Property Administration for its immunotherapy product, AllocetraTM. This patent strengthens the Company's intellectual property rights in China by covering methods, uses, and pharmaceutical compositions associated with AllocetraTM, aimed at treating life-threatening conditions such as sepsis and COVID-19. Enlivex focuses on developing immunotherapies for unmet medical needs, particularly in organ dysfunction and cancer therapies.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced positive interim results from its Phase II clinical trial of AllocetraTM in severe and critical COVID-19 patients. Out of eight treated patients, seven fully recovered and were discharged within an average of 4.7 days, while one patient improved from critical to moderate/severe. The treatment was well tolerated with no serious adverse events reported. The trial is part of a multi-center study aimed at evaluating AllocetraTM alongside standard care for the target patient population.
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