NEW YORK and HERZLIYA-PITUACH, Israel, April 10, 2014 (GLOBE NEWSWIRE) -- Immune Pharmaceuticals Inc. (OTCQX:IMNP) and (Nasdaq: IMNP ) ("Immune" or "the Company") announced today company highlights and its financial results for the 12-month period ended December 31, 2013.
"Immune underwent a significant transformation in 2013," said Dr. Daniel G. Teper, Chairman and CEO of Immune. "We completed the merger with EpiCept and became a publicly traded company. Our lead candidate, Bertilimumab, a first in class monoclonal antibody, has advanced to Phase II in moderate-to-severe ulcerative colitis and in bullous pemphigoid (BP), an orphan dermatological auto-immune disease. We were pleased with the recently completed private placement financing, which raised gross proceeds of $11.7 million."
Company Highlights:
- The merger with EpiCept Corporation was completed on August 25, 2013. The merger combined Immune's antibody therapeutic platform focused on the treatment of inflammatory diseases and cancer with EpiCept's clinical stage cancer candidate, Crolibulin, and its late-stage topical pain product, AmiKet™.
- Bertilimumab entered a Phase II clinical trial in moderate-to-severe ulcerative colitis. The clinical trial is a randomized, double-blind, placebo-controlled parallel group study that will evaluate the safety, clinical efficacy, and pharmacokinetic profile of Bertilimumab in subjects with active moderate-to-severe ulcerative colitis. Completion of patient enrollment and clinical results are anticipated in the first half of 2015.
- Bertilimumab entered a phase II pilot study in Bullous Pemphigoid (BP). Completion of patient enrollment and clinical results are anticipated in late 2014.
- The Company is preparing for Phase III development AmiKet™ and has re-energized its efforts to out-license the product candidate prior to the start of a Phase III trial for the treatment of neuropathic pain. AmiKet is a prescription topical analgesic cream containing the active ingredients amitriptyline and ketamine designed to provide long-term relief from the pain of peripheral neuropathies, which affects more than 15 million people in the U.S. AmiKet has been granted orphan drug status for the treatment of post-herpetic neuralgia and Fast Track designation for the treatment of Chemotherapy Induced Peripheral Neuropathies (CIPN).
- At the May 2013 ASCO meeting in Chicago, data was presented from the Phase I safety portion of a Phase 1b/II trial to assess safety and efficacy of Crolibulin in combination with Cisplatin. The trial is sponsored by the National Cancer Institute. Crolibulin is a vascular disruption agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.
- The Board of Directors was strengthened with two appointments, Rene Lerer, MD, and Daniel Kazado. Dr. Lerer is accomplished healthcare leader with more than 30 years of significant, hands-on experience. He led the transformation, diversification, and growth of Magellan Health Services (Nasdaq: MGLN ) as Chairman and CEO. Daniel Kazado is a senior advisor to Melini Capital, a family owned private and public equity firm investing in several industries.
- Immune completed a $11.7 million private placement financing in March 2014, which included several biotech specialist institutional investors as well as family office shareholders and management.
- The Senior Management Team was strengthened In April 2014 with the appointment of Eugene Williams as Chief Operating Officer and Elliott Goldstein, MD, as Chief Medical Officer . Mr. Williams was previously CEO of Dart Therapeutics, an orphan drug development company and spent 12 years at Genzyme where he held the position of Senior Vice President for Immune Therapeutics. Dr. Goldstein held leadership positions in clinical research, regulatory affairs and commercial development at Novartis, GSK, British Biotech and Maxygen.
| Immune Pharmaceuticals Inc. and Subsidiaries | ||
| Consolidated Balance Sheets Data | ||
| (in $000s) | ||
| December 31, | ||
| 2013 | 2012 | |
| ASSETS | ||
| Cash | $ 49 | $ 95 |
| Property and equipment, net | 47 | 35 |
| In-process research and development | 27,500 | — |
| Intangible assets, net | 3,607 | 3,896 |
| Total assets | $ 31,501 | $ 4,131 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Accounts payable | $ 5,181 | $ 1,801 |
| Accrued expenses | 3,572 | 654 |
| Notes and loans payable (current) | 1,546 | 36 |
| Total stockholders' equity | 5,483 | 14 |
| Total liabilities and stockholders' equity | $ 31,501 | $ 4,131 |
| Immune Pharmaceuticals Inc. and Subsidiaries | ||
| Consolidated Statements of Operations Data | ||
| (in $000s except share and per share data) | ||
| Year Ended December 31, | ||
| 2013 | 2012 | |
| Revenue: | ||
| Licensing and other revenue | 19 | — |
| Total revenue | $ 19 | $ — |
| Costs and expenses: | ||
| General and administrative | 5,448 | 5,395 |
| Research and development | 3,571 | 3,797 |
| Total costs and expenses | 9,019 | 9,192 |
| Loss from operations | (9,000) | (9,192) |
| Other income (expense): | ||
| Interest expense | (305) | (36) |
| Gain on bargain purchase | 6,444 | — |
| Warrant amendment expense | (734) | — |
| Total other income (expense), net | 3,251 | (3,372) |
| Net loss before income taxes | (5,749) | (12,564) |
| Income taxes | (11) | (11) |
| Net loss | $ (5,760) | $ (12,575) |
| Deemed dividends | (932) | — |
| Loss attributable to Common Shareholders | $ (6,692) | $ (12,575) |
| Basic and diluted loss per common share | $ (0.94) | $ (2.61) |
| Weighted average common shares outstanding | 7,088,765 | 4,826,439 |
| Immune Pharmaceuticals Inc. and Subsidiaries | ||
| Consolidated Statements of Cash Flows Data | ||
| (in $000s) | ||
| Year Ended December 31, | ||
| 2013 | 2012 | |
| Net cash used in operating activities | $ (3,868) | $ (2,820) |
| Net cash used in investing activities | (1,132) | (89) |
| Net cash provided by financing activities | 4,954 | 1,212 |
| Net decrease in cash and cash equivalents | (46) | (1,697) |
| Cash and cash equivalents at beginning of year | 95 | 1,792 |
| Cash and cash equivalents at end of year | $ 49 | $ 95 |
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to treatment, developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. The Company's lead product candidate, bertilimumab, is in clinical development for moderate to severe ulcerative colitis and Crohn's Disease as well as bullous pemphigoid, an orphan auto-immune dermatological condition, Immune licensed worldwide rights for systemic indications of bertilimumab from iCo Therapeutics (TSX-V: ICO ) (OTCQX:ICOTF) in June 2011, while iCo retained rights to all ophthalmic indications. iCo originally licensed the exclusive world-wide rights to bertilimumab in 2006 from MedImmune, the Global Research and Development Arm of AstraZeneca. Immune's pipeline also includes NanomAbs®, antibody nanoparticle conjugates, for the targeted delivery of chemotherapeutics. and Amiket™, a Neuropathic Pain drug candidate ready for Phase III. Amiket has received Fast Track designation for chemotherapy induced neuropathic pain and Orphan Drug Designation for Post Herpetic Neuralgia.
For more information, visit Immune's website at www.immunepharmaceuticals.com , the content of which is not a part of this press release.
Erik Penser Bankaktiebolag is engaged as Immune's Certified Adviser on NASDAQ OMX First North Premier.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, but not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or at all; the risk that we will not obtain approval to market and commercialize any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; risks associated with our ability to protect our intellectual property; risks associate with our ability to raise additional funds; and our liquidity. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.immunepharmaceuticals.com . You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
Immune Pharmaceuticals Inc.: 708 Third Avenue, Suite 210 New York, NY 10017 Anna Baran, Director of Investor Relations and Corporate Communications Tel: (646) 937-1941 Immune Pharmaceuticals Ltd.: 11C Galgale HaPlada Herzliya-Pituach, Israel 46733
