On March 30, Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company") reported financial results for the fourth quarter and full year ended December 31, 2015 (Filing, Q4/Annual, Immune Pharmaceuticals, 2015, MAR 30, 2016, View Source [SID:1234510242]). Immune filed its Annual Report on Form 10-K for fiscal year 2015 on March 30, 2016.
2015 Highlights
2015 was an important year for Immune as we formed a new leadership team based in New York City at the Alexandria Center for Life Science. Several key executives with successful track records at both large pharmaceutical and biotech companies have joined Immune, significantly improving our ability to execute our business plan:
· Monica Luchi, MD, MBA, Chief Medical Officer and EVP, Global Drug Development;
· Miri Ben-Ami, MD, President, Immune Oncology Pharmaceuticals Inc. and Immune Pharmaceuticals Ltd (Israel);
· Mark Levitt, MD, PhD, SVP Oncology Clinical Affairs;
· John Mohr, SVP, Business Development;
· John Militello, VP, Finance and Chief Accounting Officer; and
· Boris Shor, PhD, Executive Director R&D and Scientific Partnerships.
As a result, Immune achieved several notable milestones, including:
· First patient and ongoing enrollment into Phase II clinical trials with bertilimumab in ulcerative colitis;
· Clearance by the U.S. Food and Drug Administration of our Investigational New Drug application for bertilimumab for the treatment of bullous pemphigoid, an auto-immune orphan dermatological disease, allowing for expansion of the clinical trials to the United States;
· Acquisition of worldwide rights to NanoCyclo, a topical nano-formulated cyclosporine for the treatment of moderate atopic dermatitis and psoriasis; and
· In-licensing of a novel bispecific antibody technology and establishment of an R&D laboratory in NYC under the leadership of Dr. Shor, a former Pfizer executive, to focus on the development of bispecific antibodies targeting immune checkpoints and specific tumor targets.
Given the scope of Immune’s development stage portfolio, we have initiated the establishment of a subsidiary with a focus on immuno-oncology therapeutic assets and technologies, allowing the Company to leverage the breadth of its new management team and to access financing opportunities in this vast area of unmet need. The newly established company, Immune Oncology Pharmaceuticals Inc., was created at the end of the first quarter of 2016, under the leadership of Dr. Miri Ben-Ami. Its portfolio includes Ceplene, a cancer immunotherapy for the treatment of Acute Myeloid Leukemia in combination with low dose IL-2; Azixa and crolibulin, Phase II vascular disrupting agents; and bispecific antibodies and NanomAbs (antibody nanoparticle conjugates), two innovative platforms to generate a pipeline of drug candidates. New European Phase IV data on Ceplene was published in two issues of Oncotarget (November 2015 and February 2016) and will be presented at the American Academy of Cancer Research on April 17, 2016. These data and additional analysis from previous trials with Ceplene may support design of an overall survival registrational trial in the U.S. Preclinical data in support of the bispecific antibody platform was published on February 26, 2016 in The Journal of Immunology.
"I am pleased, excited and gratified with the major clinical and organizational accomplishments during the year 2015." said Dr. Daniel Teper, CEO of Immune Pharmaceutical Inc. "We expect 2016 to be an important year for Immune, with several anticipated data milestones for the Company’s product candidates, while we seek to unlock the potential value of our pipeline through financing and strategic partnering opportunities of specific asset groups."
4th Quarter and Full Year 2015 Financial Discussion
Immune reported a loss attributable to common stockholders of $8.2 million, or $0.27 per share, for the quarter ended December 31, 2015, compared to a loss attributable to common stockholders of $7.0 million, or $0.34 per share, for the quarter ended December 31, 2014. For the year ended December 31, 2015, Immune reported a loss attributable to common stockholders of $24.1 million, or $0.90 per share, compared to a loss attributable to common stockholders of $24.4 million, or $1.46 per share, for the year ended December 31, 2014.
R&D expenses increased by $0.9 million during the quarter ended December 31, 2015 to $2.5 million compared with $1.6 million during the quarter ended December 31, 2014. For the year ended December 31, 2015, R&D expenses increased by $0.3 million to $5.9 million compared with $5.6 million during the year ended December 31, 2014. The increase in R&D expenses for the fourth quarter and full year of 2015 was mainly due to an increase in outsourced consulting services related to the Phase II clinical trials of bertilimumab. Additionally, R&D related staff increased, positioning Immune to fully execute on its R&D programs in 2016.
General and administrative expense increased by approximately $1.2 million during the quarter ended December 31, 2015 to $3.6 million, compared with $2.4 million during quarter ended December 31, 2014, due to higher payroll expense as a result of the move of the Company’s headquarters from Israel to New York during fiscal 2015 and the hiring of additional U.S. employees. For the year ended December 31, 2015, general and administrative expense decreased by approximately $0.9 million, or 9%, to $9.8 million, compared with $10.7 million during year ended December 31, 2014. The decrease was primarily due to a reduction in stock compensation expense of $2.6 million due to the vesting of shares issued to consultants in 2014, partially offset by increased payroll expense due to the moving of the Company’s headquarters from Israel to New York in fiscal 2015 and the hiring of additional U.S. based employees.
Non-operating expense decreased by $2.6 million to $0.4 million during quarter ended December 31, 2015 compared with non-operating expense of $3.0 million during quarter ended December 31, 2014. For the year ended December 31, 2015, non-operating expense amounted to $1.4 million compared with non-operating expense of $7.2 million during year ended December 31, 2014, a decrease of $5.7 million. Non-operating expense for the year ended December 31, 2015 consisted of interest expense of $0.8 million primarily relating to cash interest paid and amortization of the debt discount for the Company’s loan and security agreement with Hercules. In addition, the Company recognized a loss on the extinguishment of debt of $0.5 million due to early termination fees in conjunction with the repayment of the MidCap senior secured term loan during 2015. Non-operating expense for the year ended December 31, 2014 consisted of interest expense of $3.4 million primarily due to a $2.2 million charge for the accelerated vesting of restricted stock recorded as debt issuance costs and included $3.1 million in warrant amendment expense in conjunction with the amendment of the March 2014 Warrants.
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