For those of you investigating a purchase here you might consider the fact that management has purchased shares well above this weeks closing prices and the most recent developments are listed below are positive in my opinion.
Immune Pharmaceuticals Signs Agreement to Fund Maxim Pharmaceuticals, Inc., its Pain and Neurology subsidiary NEW YORK, Sept. 16, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (IMNP) ("Immune" or the "Company"), a biopharmaceutical company focused on the development of targeted therapeutics for the treatment of inflammatory diseases and cancer, announced today that the Board of Directors has approved to designate Maxim Pharmaceuticals Inc. ("Maxim"), one of the Company's existing subsidiaries, as the dedicated entity to develop and commercialize, and hold the intellectual property related to, AmiKet® and other related pain and neurology assets. In addition, the Company has entered into a binding agreement with NPT (the "Binding Agreement"), a syndicate of experienced healthcare investors, pursuant to which NPT or its designees have agreed to purchase up to $20 million of the capital stock of Maxim, with an initial funding of $5 million to occur within thirty days. Previously, the Company entered into an option agreement with NPT, dated May 15, 2016, as amended on July 18, 2016. Pursuant to the Binding Agreement, immediately following the $5 million initial funding by NPT, Immune will expand the Board of Directors of Maxim, to five members which will include one NPT representative, and a newly hired Chief Executive Officer of Maxim.
For full disclosure please refer to the Form 8-K filed on September 16, 2016
Immune Pharmaceuticals Receives $2 Million Investment in Common Stock at $0.50 per Share Immune Pharmaceuticals Inc. (IMNP) ("Immune"), a biopharmaceutical company focused on the development of targeted therapeutics for the treatment of inflammatory diseases and cancer, announced today that it has entered into a stock purchase agreement with an existing stockholder for the sale of 4,000,000 shares of the Company's common stock at a fixed price of $0.50 per share, for gross proceeds of $2,000,000. There are no warrants, no restrictive covenants, and no restrictions on use of proceeds.
For full disclosure, please refer to the Form 8-K filed on September 7, 2016.
Immune Pharmaceuticals Provides Business and R&D Update and Announces Second Quarter 2016 Financial Results
Immune Pharmaceuticals Inc. (IMNP) ("Immune" or the "Company") announced financial results for the second quarter and six months ended June 30, 2016 as well as provided pipeline highlights and a business update.
"Immune has continued to make significant R&D and operational progress, while we seek to unlock the potential value of our pipeline through institutional financing and corporate transaction opportunities," said Dr. Daniel Teper, CEO of Immune Pharmaceuticals Inc. Pipeline Highlights Immuno-inflammation
Bertilimumab continues to accrue patients in its two phase 2a clinical trials in bullous pemphigoid (BP) and ulcerative colitis (UC). The BP trial is expanding to six US centers in addition to the two Israeli centers. The first US center was initiated in August 2016 and started to screen patients with others to follow shortly. The UC trial is expanding to Eastern Europe with site initiations to be completed in the fourth quarter of 2016. An additional phase 2a trial in Atopic Dermatitis (AD) is in final planning stages in Canada. In the second quarter of 2016, new pre-clinical data was generated in AD and a new provisional patent was filed in partnership with Hadasit, the technology transfer of Hadassah hospital, for oral use of anti-eotaxin antibodies in Non-Alcoholic Steato-Hepatitis (NASH). Immune also advanced process development for its new cell line for the production of bertilimumab. Immune expects to bridge to the new cell line starting in mid-2017. Immune is assessing options for development of a sub-cutaneous formulation of bertilimumab. Immune advanced the development of NanoCyclo, a topical formulation of cyclosporine A for the potential treatment of AD and psoriasis. We are currently focused on the GMP manufacturing process and pre-clinical regulatory studies toward filing of an Investigational New Drug application in 2017. Immuno-oncology We are continuing to advance our plans to focus on our two clinical stage assets in oncology, Ceplene® and Azixa® and have made significant progress in the past quarter with both of these assets.
Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia (AML), an orphan indication with poor survival prognosis, for which no effective therapy is available to patients. Presented new positive biomarker driven clinical data from the European Phase IV study at the American Association of Cancer Research (AACR) Annual meeting in New Orleans in April 2016. The phase IV RE:MISSION trial was designed to assess the immuno-modulatory properties of Ceplene/IL-2, and to correlate potential biomarkers with clinical outcome. Results indicated that outcomes were strongly predicted with a specific T-cell biomarker including leukemia-free survival (LFS) (HR 0.25, P=0.001) and overall survival (OS) (HR 0.24, P=0.009). Reported new data showing that Ceplene enhanced response to PD-1 and PD-L1 checkpoint inhibitors in lymphoma and solid tumor models. This data is supporting the provisional patent application filed in the first quarter of 2016 for use of Ceplene in combination with check point inhibitors. Presented new data at the Conference "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" held in Philadelphia, PA providing further mechanistic evidence to explain the promising efficacy of Ceplene in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and the recently completed Phase IV clinical trials. Immune now plans to leverage recent Ceplene/IL-2 data on predictive bio-markers and recent phase IV data results to design and reach an agreement with the FDA for a pivotal study in AML supporting a new drug application in the U.S.
Presented new positive biomarker driven clinical data from the European Phase IV study at the American Association of Cancer Research (AACR) Annual meeting in New Orleans in April 2016. The phase IV RE:MISSION trial was designed to assess the immuno-modulatory properties of Ceplene/IL-2, and to correlate potential biomarkers with clinical outcome. Results indicated that outcomes were strongly predicted with a specific T-cell biomarker including leukemia-free survival (LFS) (HR 0.25, P=0.001) and overall survival (OS) (HR 0.24, P=0.009). Reported new data showing that Ceplene enhanced response to PD-1 and PD-L1 checkpoint inhibitors in lymphoma and solid tumor models. This data is supporting the provisional patent application filed in the first quarter of 2016 for use of Ceplene in combination with check point inhibitors. Presented new data at the Conference "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" held in Philadelphia, PA providing further mechanistic evidence to explain the promising efficacy of Ceplene in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and the recently completed Phase IV clinical trials. Immune now plans to leverage recent Ceplene/IL-2 data on predictive bio-markers and recent phase IV data results to design and reach an agreement with the FDA for a pivotal study in AML supporting a new drug application in the U.S.
Azixa is a novel microtubule destabilizer that has a dual mode of action, acting as a vascular disrupting agent (VDA) and a potent cytotoxin with a unique ability to penetrate the blood brain barrier and reach high concentrations in the brain. Generated and reported new data demonstrating that the combination of Azixa and immune checkpoint inhibitors such as anti-CTLA-4 antibody resulted in enhanced activity compared to the activity elicited by the single agents alone. Filed a provisional patent application with the USPTO relating to the combination of Azixa and immune checkpoint inhibitors such as an anti-CTLA-4 antibody and anti-PD1 monoclonal antibodies in the treatment of cancer. Generated and reported new data demonstrating that the combination of Azixa and immune checkpoint inhibitors such as anti-CTLA-4 antibody resulted in enhanced activity compared to the activity elicited by the single agents alone. Filed a provisional patent application with the USPTO relating to the combination of Azixa and immune checkpoint inhibitors such as an anti-CTLA-4 antibody and anti-PD1 monoclonal antibodies in the treatment of cancer.
Business Update On July 18, 2016, the Company signed an amendment to the May 15, 2016 Option Agreement with Novel Pain Therapeutics, LLC (NPT), a syndicate of experienced healthcare investors. Immune agreed to designate a subsidiary that will hold all of the Intellectual Property for Immune's pain assets (Amiket®, Amiket Nano™ and LidoPain®). Under the terms of the Amended Option Agreement, the parties have agreed to a pre-money valuation of $15 million for Immune's equity stake in the pain subsidiary with a target closing date of September 15, 2016 for the first tranche of dedicated financing by NPT and other investors. In addition, subject to the exercise of the Option Agreement and the execution of the definitive License Agreement, as well as the ultimate development, sale and/or licensing of the products, Immune will be eligible to receive up to $145 million in milestone payments as well as sublicensing fees and royalties.
Second Quarter and Six Months Ended June 30, 2016 Financial Discussion Immune reported a loss attributable to common stockholders of $5.7 million, or $0.13 per share, for the quarter ended June 30, 2016, compared to a loss attributable to common stockholders of $2.9 million, or $0.12 per share, for the quarter ended June 30, 2015. For the six months ended June 30, 2016, Immune reported a loss attributable to common stockholders of $11.7 million, or $0.30 per share, compared to a loss attributable to common stockholders of $8.2 million, or $0.34 per share, for the six months ended June 30, 2015.
Research and Development ("R&D") expenses increased by $0.8 million during the quarter ended June 30, 2016 to $1.9 million compared with $1.1 million during the quarter ended June 30, 2015. For the six months ended June 30, 2016 R&D expenses increased by $1.7 million to $4.0 million from $2.3 million. The increase in R&D expenses for the quarter and six months ended June 30, 2016 was primarily driven by higher salaries, employee benefits and share-based compensation as a result of higher R&D headcount. In addition, the increase in R&D expenses was driven by higher clinical trial expenses as the Company continues to ramp up its clinical trials related to bertilimumab in both BP and UC.
General and Administrative ("G&A") expenses decreased $0.8 million during the quarter ended June 30, 2016 to $0.9 million compared with $1.7 million during the quarter ended June 30, 2015, due to lower share based compensation expense and lower consulting and business development expenses. For the six months ended June 30, 2016 G&A expenses decreased by $0.6 million to $3.4 million from $4.0 million during the six months ended June 30, 2015 primarily due to lower share based compensation expense and lower legal fees.
Non-operating expense was $0.7 million during the three months ended June 30, 2016 compared with non-operating expense of $0.1 million during the three months ended June 30, 2015. For the six months ended June 30, 2016, non-operating expense was $1.4 million compared with $0.2 million for the six months ended June 30, 2015. Non-operating expense increased for the three and six months ended June 30, 2016 primarily relating to cash interest expense and amortization of debt issuance costs for the Company's loan agreement and the loss on the change in fair value of derivative liability instrument.
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