Immune Pharmaceuticals CEO Updates Shareholders On Company Progress
Additional Insider Buying Confirms Board and Management Confidence
Dec 9, 2015
NEW YORK, Dec. 9, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") a clinical-stage company developing novel therapies for the treatment of immuno-inflammatory diseases and cancer, is holding today its annual shareholder meeting.
Dr. Daniel Teper, CEO, comments, "First off, let me personally thank the majority of our shareholders that have held their position despite the volatility of the market and of our stock. 2015 was a positive foundation year for our company as we delivered some major clinical and organizational accomplishments over the past months. 2016 promises to be an important year for Immune shareholders with several anticipated data milestones. In particular, we are confident that favorable Phase II clinical data for bertilimumab will add significant value. In addition, we will be actively seeking strategic partnering opportunities to advance our overall product portfolio."
In 2015 , Immune made important progress with its lead drug candidate, bertilimumab, receiving clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application allowing us to include U.S. patients in our Phase II clinical trial in bullous pemphigoid, an orphan auto-immune disease of the skin, and starting to enroll patients in the Phase II clinical trial in moderate to severe ulcerative colitis, a serious immuno-inflammatory condition of the gastro-intestinal tract.
The Company secured financing allowing us to execute the development plan for our lead drug candidate, bertilimumab, through Phase II clinical trials data, and relocated corporate headquarters to New York City at the Alexandria Center for Life Sciences, the heart of the NYC medical and biotech corridor. Immune has hired a new leadership team with a proven track record of execution in both pharma and fast growth biotech companies: Monica Luchi, M.D., our new Executive Vice President and Chief Medical Officer, formerly at Novartis, Incyte and Mesoblast; Miri Ben Ami, M.D., Executive Vice President, Oncology and President Immune Pharmaceuticals Ltd., formerly at Teva and Aposense; G. John Mohr, Senior Vice President, Business Development, formerly at Merck and CV Therapeutics. The Company is now committed to further strengthening its board of directors with the addition of members with successful leadership experience at public biotech companies.
We expect 2016 to be an inflexion year for Immune Pharmaceuticals, with several planned milestones. We anticipate that our efforts to expand the number of clinical trial centers will allow for quality and timely data for both bertilimumab Phase II clinical trials in 2016, and will support further development in those indications as well as potential new indications. We anticipate further strengthening of our Immuno-Dermatology franchise with pre-clinical data and potential initiation of Phase II clinical trials for bertilimumab in severe atopic dermatitis We also plan to advance nano-cyclosporine A, a topical formulation of an oral drug for atopic dermatitis and psoriasis, expanding the treatment to patients with moderate disease.
We also anticipate further development of our Immuno-Gastro-Enterology and Liver Diseases franchise with completion of enrollment and initial results of our phase II double blind placebo controlled proof of concept ulcerative colitis supporting potential further development of bertilimumab in both ulcerative colitis and Crohn's disease; feasibility studies for a companion diagnostic allowing for patient stratification and selection based on eotaxin-1 levels and new data providing guidance on potential clinical development of bertilimumab in inflammatory liver diseases such as Non Alcoholic Steato Hepatitis (NASH) in a select patients over-expressing eotaxin-1.
We believe that each of our two areas of focus, Immuno-Dermatology (bullous pemphigoid, atopic dermatitis, and psoriasis) and Immuno-Gastro-Enterology (Crohn's disease and ulcerative colitis) have addressable market opportunities exceeding $ 10 billion. Additional value is expected from our Immuno-Oncology pipeline and from the partnering of clinical stage assets in both Cancer and Pain.
The coming year promises to be exciting with both data and partnering events. The entire team at Immune appreciates the shareholder support in helping bring novel and needed therapies to patients with immuno-inflammatory diseases and cancer.
Immune Pharmaceuticals (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in phase II clinical development for moderate to severe ulcerative colitis as well as for bullous pemphigoid, an orphan auto-immune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH(an inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes, bi-specific antibodies nano-therapeutics, including NanomAbs®,and several mid- to late stage small molecules. Immune's non-core pipeline includes AmiKet™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at
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, but not limited to: 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 or AmiKet™ will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAbs 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, on 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. We expressly disclaim any obligation to publicly update any forward looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Immune Pharmaceuticals, Inc.
For further information: Christine J. Petraglia, Director, Investor Relations, IMMUNE Pharmaceuticals, Inc., 646.440.9332, firstname.lastname@example.org