RE:imnp call Immune Pharmaceuticals Announces Third Quarter 2015 Corporate Update, Financial Results and Conference Call Details
Expansion of Bertilimumab Phase 2 Clinical Trials to the U.S. and Europe
NEW YORK, Nov. 12, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announces corporate update and three months and nine months ended September 30, 2015 financial results.
Recent Highlights, Upcoming Milestones and Third Quarter 2015 Financial Results
Dr. Daniel Teper, CEO of Immune stated, "Over the past few months we have made decisive progress in the clinical development of our lead product candidate and first–in-class monoclonal antibody, bertilimumab, which targets eotaxin-1, a key regulator of immuno-inflammation. We recently announced the acceptance of an Investigational New Drug (IND) application for bullous pemphigoid (BP) by the U.S. FDA. This will allow us to add U.S. clinical sites, including Mount Sinai for our Phase 2 clinical trial and EU sites, upon regulatory clearance there. We intend to follow the same regulatory approach for the ulcerative colitis (UC) clinical trial and believe this clearance may allow us to complete our BP clinical trial in the first half of 2016 and UC clinical trial by the end of 2016. We expect our recent July financing will allow for the completion of both studies which are significant clinical milestones for bertilimumab."
Recent Highlights
- IND application for bertilimumab in BP accepted by the U.S. FDA
- Dr. Daniel Teper, CEO, initiated up to $250,000 10b5-1 stock purchase plan
- Boris Shor joins Immune from Pfizer as executive director of R&D and scientific partnerships
- Received guidance from a liver disease scientific advisory board for a preclinical and clinical plan to evaluate the relevance of bertilimumab for inflammatory liver diseases such as NASH and PSC
- Received guidance from a pain scientific advisory board to support AmiKet/AmiKet Nano partnering based on a streamlined Phase 3 clinical trial program, and improved target product profile with a broad neuropathic pain label and a novel AmiKet Nano formulation
- Received gross proceeds of $16.5 million with access to an additional $5.0 million in gross proceeds prior to June 15, 2016, subject to certain clinical milestones and other conditions
Upcoming Milestones and 2016 Priorities
Immune plans to build shareholder value by striving to achieve key strategic objectives, including:
- Continuing patient enrollment in UC and BP clinical trials in Israel, Europe and United States
- Orphan Designation for bertilimumab in BP
- Clinical results for bertilimumab Phase 2 clinical trial in BP
- Clinical results for bertilimumab Phase 2 clinical trial in UC
- Filings of U.S. and EU IND for bertilimumab in multiple indications
- On-going development of topical nano- cyclosporine for moderate atopic dermatitis and moderate psoriasis
- Initiation of AmiKet/ AmiKet Nano pivotal development by a corporate partner
- Structuring of an oncology business unit and seeking financing of immuno-oncology pipeline
Third Quarter 2015 Financial Results
Third quarter total operating expenses, including research and development and general and administrative expenses decreased by approximately $3.0 million to $3.3 million compared with $6.4 million during the third quarter of 2014. This decrease was primarily due to reductions in non-cash employee stock compensation expense.
As of September 30, 2015, cash and cash equivalents were $9.0 million and approximately 29 million common shares outstanding.
Our quarterly report on Form 10-Q for the quarter ended September 30, 2015 will be filed with the SEC.
Conference Call
Immune will host a quarterly conference call and corporate update this morning, Thursday, November 12, 2015, at 11am EDT. Domestic callers (toll-free US and Canada) may dial (866) 373-3402 and International callers dial (201) 689-7825. A live and recorded audio webcast will be available by visiting the Company's website at www.immunepharmaceuticals.com