Nes Ziona, Israel, April 8, 2019 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced the final closing of a private placement financing of ordinary shares priced at $12.25 per share, raising a total of approximately $8.4 million.
The final closing of $3.0 million on April 4, 2019 follows the initial closing of approximately $5.4 million previously announced by Enlivex on March 26, 2019. Pursuant to the financing, Enlivex expects its cash balance to allow initiation of several late-stage immunotherapy clinical trials, and potentially reach multiple clinical milestones through (i) a Phase II/III trial studying prevention of complications post bone-marrow transplantations; (ii) a Phase II trial studying prevention of cytokine storms associated with sepsis, and (iii) a unique program surrounding a proprietary “immune checkpoint” discovered by Enlivex for treatment of solid cancers.
Enlivex is developing a novel immunotherapy candidate with a unique mode of action that targets clinical indications defined as “life-threatening, unmet medical need,” such as preventing or treating complications associated with bone-marrow transplantations, sepsis – which is the third-leading cause of mortality in the United States after cardiovascular and cancer diseases, as well as treatment of solid tumors via immune checkpoint reprogramming, potentially increasing the efficacy of CAR-T, TCR and other anti-cancer therapies.
Pursuant to the private placement, Enlivex issued an aggregate of 682,631 ordinary shares, following which Enlivex had 10,113,707 ordinary shares outstanding.
The ordinary shares issued by Enlivex in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from registration requirements. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs), as well as solid tumors immune-checkpoint rebalancing. For more information, visit http://www.enlivex.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA™ programs, and potential future payments to holders of CVRs which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the Trehalose program may not generate any revenues, and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA™ product line or the Trehalose program could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission. The forwardlooking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX
CFO Enlivex Therapeutics, Ltd.