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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 (Nasdaq: ENLV), a clinical-stage immunotherapy company, announced its participation in two upcoming investor conferences. Management will join the 2nd Annual European Healthtech CEO Forum on March 9, focusing on patient care during the pandemic. They will also present at the H.C. Wainwright Global Life Sciences Conference on March 10, addressing innovative allogeneic cell-based immunotherapy in oncology. Enlivex is developing Allocetra™, a cell therapy aimed at reprogramming macrophages to their homeostatic state, potentially aiding in severe diseases like COVID-19 and solid cancers.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the Japan Patent Office has granted a notice of allowance for a new patent covering AllocetraTM, its macrophage reprogramming immunotherapy product. This patent, titled “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment,” will protect certain methods and uses of AllocetraTM in conjunction with CAR-T therapies in Japan. The company anticipates the patent will be officially issued in Q2 2021, further strengthening its intellectual property portfolio.
Enlivex Therapeutics Ltd. announced a collaboration with Mount Sinai Health System on March 1, 2021, to explore the use of Allocetra™ in combination with immune-checkpoint inhibitors for treating solid tumors. This pre-clinical program aims to investigate potential synergies between Allocetra™ and approved checkpoint inhibitors, enhancing anti-tumor responses by reprogramming macrophages. Enlivex reported positive interim results from trials involving COVID-19 and sepsis patients, indicating a promising future for Allocetra™ in immunotherapy.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the China National Intellectual Property Administration granted a notice of allowance for a new patent covering AllocetraTM, its macrophage reprogramming immunotherapy. This patent will enhance intellectual property protection in China, covering methods and uses for AllocetraTM. The product aims to reprogram macrophages to their homeostatic state, potentially addressing diseases like sepsis, COVID-19, and solid tumors. Issuance of the patent is expected in the coming months.
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.
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