NEW YORK–(BUSINESS WIRE)–Immune Pharmaceuticals Inc. (NASDAQ:IMNP) (“Immune” or the “Company”) provided the following R&D and business update and summary of recent financial highlights.
Immune continues to focus on the development of its two core assets: (1) bertilimumab, a first in class, monoclonal antibody in Phase 2 clinical development for Bullous Pemphigoid (“BP”) an orphan autoimmune dermatological condition affecting approximately 30,000 patients in the United States, and Ulcerative Colitis (“UC”) a chronic inflammatory bowel disease (IBD) distinguished by inflammation of the large intestine (rectum and colon); and (2) a topical nano-formulation of cyclosporine for the treatment of psoriasis and atopic dermatitis, also known as atopic eczema, an inflammatory skin disease.
- We continue to enroll subjects into the Phase 2 open label BP trial. Six subjects have been enrolled, with a target enrollment of 12 to 15. We look forward to the completion of this proof-of-concept study and subsequent publication early in 2018. Our Orphan Drug Designation application for bertilimumab in BP was filed in February 2017.
- We continue to enroll subjects into the Phase 2 placebo-controlled, double-blind clinical trial of bertilimumab in UC. Seventeen subjects have been enrolled, with a target enrollment of 42. We expect to complete the study in the second quarter of 2018.
- We are developing an improved manufacturing process for bertilimumab, using a proprietary and highly productive cell line, which will reduce cost of goods significantly.
- We have initiated development of a sub-cutaneous delivery formulation of bertilimumab.
- Dr. Tony Fiorino joined us as our Chief Medical Officer and Chief Operating Officer.
Cytovia Spin-off Update
Progress continues on segregating our oncology assets into Cytovia, Inc. and recruitment of a Cytovia management team in preparation of a spin-off and a distribution of Cytovia’s shares to Immune’s shareholders.
- Dr. Daniel Teper was named Chief Executive Officer of Cytovia.
- Mr. Rama Rao, a former Novartis executive, was appointed as Cytovia’s interim Chief Financial Officer and Chief Operating Officer.
- Preparation is ongoing for filing a Form 10 registration statement with the Securities & Exchange Commission (“SEC”) which allows for Cytovia to register a class of securities with the SEC. Cytovia anticipates applying for listing of its securities on an eligible NASDAQ trading market at the appropriate time, which shall be subject to satisfaction of the NASDAQ exchange listing criteria and approval. We intend to distribute shares in the spun-off Cytovia Inc. to our (Immune) shareholders as a dividend in proportion to each holder’s ownership of shares in Immune.
Second Quarter 2017 and Recent Financial Highlights
- Total cash and non-cash operating expenses of approximately $2.8 million for the quarter ended June 30, 2017 was reduced from total expenses of approximately $2.9 million for the same period last year.
- During the six months ended June 30, 2017, net cash provided by financing activities was $4.2 million. The proceeds from these financings are enabling us to pursue our phase 2 trials and R&D activities and refinancing transactions with strategic investors and/or corporate partners.
- On June 15, 2017, we entered into an Asset Purchase Agreement with Meda Pharma SARL, a Mylan N.V. company, to repurchase assets relating to Ceplene (histamine dihydrochloride) including the right to commercialize Ceplene in Europe and to register and commercialize Ceplene in certain other countries, for a fixed consideration of $5.0 million payable in installments over a three-year period and an additional $3.0 million contingent on achievement of certain sales milestones. As a result of the acquisition, Cytovia owns worldwide rights for Ceplene. Prior to the acquisition, Cytovia owned rights for Ceplene in North America, Latin America and Israel.
- On July 7, 2017, we refinanced approximately $3 million of outstanding senior secured debt owed to Hercules Capital, Inc. by issuing a senior secured convertible promissory note with a similar principal amount, thereby eliminating significant monthly cash amortization payments.
- On July 10, 2017, Cytovia entered into an exclusive licensing agreement with Pint Pharma International S.A. (“Pint”) a specialty pharmaceutical company focused on Latin America and other markets, for the marketing, commercialization and distribution of Ceplene throughout Latin America. Pursuant to the Licensing Agreement, Cytovia is entitled to (i) 35% of net sales in the Territory (ii) a milestone payment of $0.5 million when net sales of Ceplene in the Territory reach $10.0 million in any calendar year and (iii) a milestone payment of $1.25 million when net sales of Ceplene in the Territory reach $25.0 million in any calendar year. Pint Gmbh will separately enter into an investment agreement, which will lead to an investment of $4 million into Cytovia. Also, Dr. Massimo Radaelli, Executive Chairman of Pint, intends to join the board of Cytovia upon completion of the investment and effective spin off of Cytovia from Immune.
- On August 24, 2017, Immune entered into definitive agreements with several institutional investors for the sale of $858,000 in principal amount of original issue discount convertible debentures. The proceeds from the offering, before deducting fees and expenses, is approximately $660,000. Maxim Group LLC acted as the sole placement agent for the offering. The debentures will not be convertible until Immune obtains shareholder approval for any such conversions. The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”) or any state securities law. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state laws. In connection with the contemplated sale of the securities, the Company will rely upon the exemption from registration provided by Section 4(a)(2) under the Securities Act of 1933, as amended, for transactions not involving a public offering.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune’s lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn’s disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune’s pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.
Immune’s oncology subsidiary, Cytovia, plans to develop and commercialize Ceplene® in combination with IL-2 for maintenance remission in AML. Additional oncology pipeline products include Azixa® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.
For more information, please visit Immune’s website at www.immunepharma.com, the content of which is not a part of this press release.
The statements in this news release made by representatives of Immune Pharmaceuticals, Inc. relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilumumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q periodic reports filed on Form 8-K.
Immune Pharmaceuticals Inc.