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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Aptose Biosciences, 2015, MAR 30, 2016, View Source [SID:1234510174])

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8-K – Current report

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.

Actinium Receives Orphan Drug Designation From FDA for Iomab-B in Treating Refractory and Relapsed Acute Myeloid Leukemia in Elderly Patients

On March 30, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a Bone Marrow Transplant (BMT) (Press release, Actinium Pharmaceuticals, MAR 30, 2016, View Source [SID:1234510231]). Iomab-B will soon begin a 150 patient, pivotal Phase 3 multicenter trial in relapsed and refractory AML patients over the age of 55.

Sandesh Seth, Executive Chairman of Actinium stated, "We are pleased to have been granted orphan drug status by the FDA for Iomab-B, particularly ahead of its pivotal Phase 3 clinical trial. There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone. Orphan drug status for Iomab-B follows Actimab-A, which was granted the designation in November 2014. Orphan drug status provides Actinium with several development and financial incentives, including seven years of market exclusivity in the United States, if Iomab-B receives marketing approval and exemption from prescription drug user fees."

About Orphan Drug Status

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides a drug developer with certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication; potential tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About Iomab-B

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

Verastem Announces Presentation of Scientific Data Supporting FAK Inhibition in Combination with Immunotherapy at the Keystone Symposium on Cancer Pathophysiology

On March 30, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported the oral presentation of preclinical data by the Company’s scientific collaborator David G. DeNardo, PhD, Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicine in St. Louis, at the Keystone Symposium on Cancer Pathophysiology being held March 28 – April 1, 2016 in Breckenridge, CO (Press release, Verastem, MAR 30, 2016, View Source;p=RssLanding&cat=news&id=2151878 [SID:1234510228]).

"To date, single-agent immunotherapy has achieved limited clinical benefit for patients suffering from pancreatic cancer," said Dr. DeNardo. "This is thought to be due to abundance of tumor-associated immune-suppressive cells in pancreatic tumors along with the dense stroma that prevents T cell entry. Our data show that Verastem’s FAK inhibitor dramatically reduced tumor stroma and reduced numbers of immunosuppressive cells in pancreatic cancer models. Further, when the FAK inhibitor was combined with immune checkpoint antibodies, the tumors became highly responsive leading to a near tripling of survival times relative to checkpoint inhibitors alone."

Jonathan Pachter, PhD, Verastem Head of Research, added: "The data presented today by Dr. DeNardo at the Keystone Symposium provide important support and rationale for the ongoing Phase 1 dose-escalation clinical study evaluating Verastem’s FAK inhibitor VS-6063 in combination with pembrolizumab and gemcitabine in patients with pancreatic cancer."

Details for the presentation at the Keystone Symposium on Cancer Pathophysiology are as follows:

Oral Presentation
Title: Reprogramming the Tumor Microenvironment to Facilitate Responses to Immunotherapy
Session: Immune Cells I: Adaptive and Innate Immune Cells in the Tumor Microenvironment (TME)
Date and time: Wednesday, March 30, 2016 at 8:00 – 11:15 AM MT

A copy of the oral presentation will be available following the presentation at http://bit.ly/R3M6wc

About Focal Adhesion Kinase

Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for patients with cancer.

8-K – Current report

On March 30, 2016 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics in dermatology and ophthalmology that address significant unmet medical needs, reported its financial results for the fourth quarter and year ended December 31, 2015, and provided a business update (Filing, Q4/Annual, RXi Pharmaceuticals, 2015, MAR 30, 2016, View Source [SID:1234510225]).

"During the last quarter of 2015, RXi advanced its pipeline with the initiation of three clinical trials and the selection of two self-delivering RNAi (sd-rxRNA) compounds for cosmetic product development, all while staying within the financial projections we have provided in the course of 2015," said Dr. Geert Cauwenbergh, President and CEO of the Company. He added that, "We have now repeatedly shown the value of our proprietary sd-rxRNA platform over the course of this past year. Clinical observations have confirmed efficacy with RXI-109, an sd-rxRNA compound, in our Phase 2 clinical trials in patients with hypertrophic scars. We further showed that sd-rxRNAs reduce expression levels in the retina and cornea of primates, as well as long-non coding RNAs in cell cultures, in a potent and target specific manner. While working to accomplish our long term development goals, we also selected two sd-rxRNA compounds to advance on a much shorter cosmetic product development path, which we hope may bring shareholder value in the nearer term. As mentioned on several occasions in the recent past; with the necessary clinical studies ongoing for RXI-109 in dermatology and ophthalmology, and with SamcyproneTM for the treatment of cutaneous warts, we foresee our news flow this year to include new data points in preclinical R&D throughout the whole year, as well as early read-outs of the ongoing clinical studies in the second half of 2016. In addition, business development contacts and interactions with other pharmaceutical and biotech companies have more than tripled in the past 6 months as compared to the previous 6-month period. As you can see from our progress in the last several months, our team continues to be very dedicated to continuing this momentum through 2016."

The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 888-669-0684. International participants may access the event by dialing: +1 862-225-5361. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Fourth Quarter and Fiscal 2015 Financial Highlights

Cash Position

At December 31, 2015, the Company had cash, cash equivalents and short-term investments of approximately $10.6 million, compared with cash and cash equivalents of $8.5 million at December 31, 2014.

The Company believes that its existing cash, cash equivalents and short-term investments should be sufficient to fund operations for at least one year.

Research and Development Expenses
Research and development expense for the quarter ended December 31, 2015 was $1.7 million, which included $0.1 million of non-cash stock-based compensation expense, as compared with $1.6 million for the quarter ended December 31, 2014, which included $0.2 million of non-cash stock-based compensation expense. Research and development expense for the year ended December 31, 2015 was $6.9 million, which included $0.6 million of non-cash stock-based compensation expense, as compared with $5.7 million for the year ended December 31, 2014, which included $0.8 million of non-cash stock-based compensation expense.

The increase in research and development expense quarter over quarter and year over year was primarily due to manufacturing expense for the RXI-109 and Samcyprone drug products for use in the Company’s clinical trials. Additionally, research and development expense increased due to an increase in headcount and for lab supplies and materials used as the Company moves forward in the development of our cosmetic targets and topical delivery applications.

General and Administrative Expenses

General and administrative expense for the quarter ended December 31, 2015 was $0.9 million, which included $0.2 million of non-cash stock-based compensation expense, as compared with $0.8 million for the quarter ended December 31, 2014, which included $0.2 million of non-cash stock-based compensation expense. General and administrative expense for the year ended December 31, 2015 was $3.3 million, which included $0.9 million of non-cash stock-based compensation expense, as compared with $3.2 million for the year ended December 31, 2014, which included $1.0 million of non-cash stock-based compensation expense.

The increase in general and administrative expense quarter over quarter and year over year was primarily due to an increase in compensation expense, as well as an increase in professional services expense due to the Company’s focus on business development activities as one of its key corporate initiatives.

Net Loss Applicable to Common Stockholders

Net loss applicable to common stockholders for the quarter ended December 31, 2015 was $2.6 million, compared with $2.8 million for the quarter ended December 31, 2014. Net loss applicable to common stockholders for the year ended December 31, 2015 was $10.4 million, compared with $12.9 million for the year ended December 31, 2014.

The decrease in net loss applicable to common stockholders for the quarter and year ended December 31, 2015 as compared to prior year periods was due to a decrease in the fair value of the Company’s preferred stock dividends offset by an increase in operating expenses, as described above. The decrease in the preferred stock dividends for the quarter ended and year ended periods was due to the full conversion of all shares of preferred stock during the second quarter of 2015, resulting in no further accumulation and future payments of dividends.

Select Fourth Quarter 2015 and Recent Corporate Highlights

Dermatology

Results from the Company’s Phase 2 clinical trial, RXI-109-1402 for the treatment of hypertrophic scars, demonstrated that RXI-109-treated sites scored better as compared to untreated sites in the same subjects, three months after the scar revision surgery. The results from clinical trials to date have helped guide the selection of dose timing and dose level. The Company initiated two new cohorts in its Phase 2 clinical trial in Q4 2015 to help define best treatment length and number of doses. The Company expects to report early results from these two cohorts later this year.

RXi selected two sd-rxRNA compounds for cosmetic product development, RXI-231 and RXI-185. Topical delivery strategies are currently in development and we expect to explore a candidate in consumer testing in 2016. These candidates are part of RXi’s partnering and business development initiative providing multiple development opportunities for non-therapeutic skin health. The combined global market potential for cosmetic product development is approximately $200 billion for skin lightening and skin rejuvenation. While preventative or therapeutic claims are not allowed for cosmetic products, they may be developed more rapidly than therapeutics, therefore their path to market may be much shorter and less expensive.

In the first quarter of 2015, the Company broadened its clinical pipeline with the addition of a topical immunotherapy, Samcyprone. This proprietary formulation of diphenylcyclopropenone (DPCP) is a Phase 2 clinical asset with large combined market potential in the target indications of warts, alopecia areata, non-malignant skin tumors and cutaneous metastases of melanoma. In December of 2015, a Phase 2 clinical trial was initiated with Samcyprone for cutaneous warts. RXI-SCP-1502 is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart present for at least four weeks. The Company anticipates that this trial will be fully enrolled by the end of 2016 with preliminary readouts available in the second half of 2016.

Ophthalmology

The Company initiated a Phase 1/2 study, RXI-109-1501, in Q4 2015 to evaluate the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring, a harmful component of numerous retinal diseases. Currently, there is no effective way to prevent the formation or progression of retinal scars that may occur as a consequence of several devastating ocular diseases. The Company anticipates sharing preliminary safety readouts in the second half of 2016.

Research

Through a collaboration with Biogazelle NV, RXi discovered that specifically designed sd-rxRNAs demonstrated robust and potent reduction of the levels of long non-coding RNAs (lncRNAs) in a target specific manner. This remarkable finding represents a significant additional value inflection point for our self-delivering platform and expands the breadth of potential therapeutic targets by four fold, thus opening additional business development and partnering opportunities for our sd-rxRNA platform.

Intellectual Property

The Company has been diligent and proactive with its approach to broadly protect its valuable corporate assets by securing patent protection for its RNAi platform and immunotherapy agent, Samcyprone. Our RNAi portfolio currently includes 72 issued patents broadly covering the composition and methods of use of our self-delivering platform technology and uses of our sd-rxRNAs targeting CTGF for the treatment of fibrotic disorders, including RXI-109 for the treatment of dermal and ocular fibrosis; new RNAi compounds and their use as therapeutics and/or cosmetics, chemical modifications of RNAi compounds that improve the compounds’ suitability for therapeutic uses (including delivery) and compounds directed to specific targets (i.e., that address specific disease states).

The Samcyprone portfolio includes one issued patent and three patent applications. The patent and patent applications cover both the compositions and methods of use of Samcyprone for the treatment of warts, human papilloma virus (HPV) skin infections, skin cancer (including melanoma) and immunocompromised patients.

The issuance of these patents not only expands and strengthens our intellectual property estate, it further increases the value proposition of both our Dermatology and Ophthalmology Franchises and positions the Company for numerous strategic partnering opportunities.