TARRYTOWN, N.Y., Aug. 26, 2013 /PRNewswire/ -- Immune Pharmaceuticals Inc. (Nasdaq OMX Stockholm Exchange: IMNP and OTCQX: EPCTD) (the "Company") announced today the completion of the merger of Immune Pharmaceuticals Ltd. and EpiCept Corporation. The merger combines Immune's antibody therapeutic platform focused on the treatment of inflammatory diseases and cancer with EpiCept's early stage cancer program and its late-stage topical pain product, AmiKet™.
Daniel G. Teper, the Company's Chairman and Chief Executive Officer, commented, "It is very gratifying to witness the culmination of our work over the past several months. Not only have we successfully completed our merger with EpiCept, but our common stock has also commenced trading in the United States and Sweden. Although we are thrilled to reach these two major milestones in our company's history, we understand that our work is just beginning as we prepare for the start of the Phase II clinical trials of bertilimumab in ulcerative colitis and bullous pemphigoid, and continue the ongoing research in our NanomAb® program. We are looking forward to executing on these initiatives and to achieving the numerous milestones we have set for ourselves in 2014 and beyond."
In connection with the merger, the Company has issued approximately 9.8 million shares of its common stock in exchange for 100% of the outstanding shares of Immune Pharmaceuticals Ltd, and will exchange the outstanding common stock warrants and options of Immune Pharmaceuticals Ltd. for warrants and options of the Company exercisable for an aggregate of approximately 4.0 million shares of the Company's common stock. The Company's total outstanding common stock was approximately 12.6 million shares immediately following the closing of the merger. The Company's common stock commenced trading on August 21, 2013 on the Nasdaq OMX Stockholm Exchange under the symbol IMNP and on the OTCQX under the symbol EPCTD. The Company's trading symbol on the OTCQX will revert to IMNP on September 19, 2013.
The Company also announced today that, in connection with the closing of the merger, the composition of the Company's board of directors has changed and increased to seven persons. Daniel Teper, the Company's Chief Executive Officer, has joined the board of directors as Chairman. David Sidransky, Professor of Oncology at the Johns Hopkins School of Medicine, has been appointed Vice Chairman. Ana Stancic has been named the chairperson of the Company's audit committee. Isaac Kobrin, Herve de Kergrohen, and Pierre Albouy have also been named to the Company's board. Robert Cook, EpiCept's previous interim President and CEO, retains his position on the board and has become the Company's Chief Financial Officer. Alan Dunton, previous non-executive chairman of EpiCept, Robert Savage, and Keith Brownlie have resigned their positions, effective as of the closing date of the merger.
Immune has initiated its Phase II program with bertilimumab and plans to begin enrolling patients into a multi-national clinical trial for the treatment of moderate-to-severe ulcerative colitis. The Company expects to begin trials in late 2013 for the treatment of bullous pemphigoid, a rare auto-immune condition that affects the skin and causes the formation of blisters. The Company anticipates data from these Phase II trials in 2014.
Bertilimumab is a first-in-class monoclonal antibody (mAb) that targets eotaxin-1, a small protein that attracts and activates several sub-classes of immune cells. These cells play a role in the development of certain inflammatory diseases, including ulcerative colitis, Crohn's disease, severe asthma and bullous pemphigoid. Early studies of eotaxin-1 have validated the target and have shown that it may serve as a mediator of disease severity. These findings are important as they suggest that eotaxin-1 levels may help guide treatment options for patients, a major step toward the personalization of treatment for inflammatory diseases.
Immune also intends to advance its NanomAb® program through the development of its own product candidates as well as through partnerships where it can apply this technology to partners' chemotherapeutic drugs. The Company's NanomAb® technology is an antibody drug conjugate (ADC) platform designed to deliver cancer drugs directly to tumor cells thereby improving efficacy and reducing off-target undesirable effects.
Within the product pipeline previously under EpiCept's control, the National Cancer Institute-run trial of crolibulin is continuing, with Phase II clinical results anticipated in 2014. Crolibulin is an active chemotherapeutic agent, which can be formulated with NanomAbs® to direct tumor targeting. AmiKet™, a prescription topical cream for the treatment of neuropathic pain, has been designated as an out-licensing candidate for Phase III development and commercialization. Although AmiKet™ has demonstrated promising clinical results, the product candidate is not well aligned with Immune's focus on highly targeted antibody therapeutics. The Company is considering taking steps to advance the drug candidate to the start of a Phase III trial while it initiates a formal out-licensing process expected to conclude in the first half of 2014.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (OTCQX: EPCTD, Nasdaq OMX Stockholm Exchange: IMNP) applies a personalized approach to treatment, developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. The company's lead product candidate, bertilimumab, is entering Phase II clinical studies for moderate-to-severe ulcerative colitis and bullous pemphigoid, with additional studies planned for severe asthma, Crohn's disease and certain ophthalmological conditions. Immune also is evaluating its NanomAb® technology with approved chemotherapeutics in order to enhance their safety and efficacy profiles by delivering the medicines directly to cancer cells. Through its merger with EpiCept Corporation in 2013, Immune expanded its oncology pipeline with additional clinical-stage product candidates.
Immune is headquartered in the U.S., with its primary research and development facilities in Israel.
For more information, visit Immune's website at www.immunepharmaceuticals.com.
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab, crolibulin or AmiKet™ will not be successful; the risk that bertilimumab, crolibulin, AmiKet™ or compounds arising from our NanomAb® program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.immunepharmaceuticals.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
|SOURCE Immune Pharmaceuticals Inc.|
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