Immune Pharmaceuticals Reports First Quarter 2015 Financial Results; Bertilimumab Phase II Trials Ready to Enroll Patients
NEW YORK, May 18, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune") announced financial results for the first quarter ended March 31, 2015. Immune filed its Quarterly Report on Form 10-Q for the first quarter of 2015 on Friday, May 15, 2015.
"In the past quarter, we relocated our leadership team to New York City and accelerated our focus on operational execution. We are now ready to commence patient enrollment in our Phase II clinical trials with bertilimumab, a first in class monoclonal antibody, for the treatment of ulcerative colitis and bullous pemphigoid," said Dr. Daniel Teper, Chief Executive Officer of Immune. "Additionally, we have received strong interest and are now in the negotiation stage for a partnering agreement for Phase III development and commercialization of AmiKet™."
On March 31, 2015, the Company had available funding of $9.0 million, including cash and cash equivalents of $4.0 million, plus a $5.0 million revolving line of credit, which is sufficient to finance its operations, anticipated capital expenditures, working capital and other financing requirements over the next twelve months under the current business plan.
Recent Business Highlights and Upcoming Milestones
STC Biologics Partnership: On May 4, 2015, the Company announced the entry into a strategic partnership with STC Biologics to accelerate the development of NanomAbs®, a new generation of Antibody Nanoparticle Conjugates allowing the targeted delivery of chemo-therapeutics.
Partnering of AmiKet may provide out-licensing revenues in 2015: Following a comprehensive review of clinical safety and efficacy of AmiKet in trials totaling 1,700 patients, meetings with regulatory agencies and a third party commercial assessment validating the significant market potential, the Company initiated a partnering process for AmiKet in the first quarter of 2015 and is now in the negotiation stage of partnering terms.
AmiKet addresses a potential market of over $3.5 billion in the treatment of Neuropathic Pain according to Global Data.
Immune also licensed a topical nanoparticle formulation technology, which has the potential to enhance the performance of AmiKet, prolong patent exclusivity up to 2036, and support development in additional pain indications.
IMMUNE PHARMACEUTICALS INC. FIRST QUARTER 2015 FINANCIAL HIGHLIGHTS
Immune reported a loss attributable to stockholders of $3.6 million or $0.15 per share, for the first quarter of 2015 compared to a loss attributable to common stockholders of $4.8 million or $0.35 per share, for the first quarter of 2014.
Research and development expenses increased by $0.8 million during the three-month period ended March 31, 2015 to $1.2 million compared with $0.3 million during the three month period ended March 31, 2014. The increase was mainly due to an increase in outsourced manufacturing and consulting costs of $0.8 million, related to our planned Phase II clinical trials for bertilimumab.
General and administrative expenses decreased by $0.2 million during the three month period ended March 31, 2015 to $2.3 million, compared with $2.5 million during the three month period ended March 31, 2014. The decrease was primarily attributable to a decrease in stock compensation expenses of $0.8 million, offset by an increase in salaries of $0.2 million.
As of March 31, 2015, the Company had 24.6 million common shares outstanding.
| Immune Pharmaceuticals Inc. Consolidated Financial Statements for the Three |
||||||||
| Condensed Consolidated Balance Sheets |
||||||||
| March 31, 2015 |
December 31, 2014 |
|||||||
| ASSETS |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ |
4,018 |
$ |
6,767 |
||||
| Restricted cash |
40 |
21 |
||||||
| Other current assets |
204 |
99 |
||||||
| Total current assets |
4,262 |
6,887 |
||||||
| Property and equipment, at cost, net of $57 and $51 accumulated depreciation, as of March 31, 2015 and December 31, 2014, respectively |
62 |
41 |
||||||
| In-process research and development |
27,500 |
27,500 |
||||||
| Intangible assets, net |
3,339 |
3,415 |
||||||
| Security deposits |
132 |
21 |
||||||
| Total assets |
$ |
35,295 |
$ |
37,864 |
||||
| LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
| Current liabilities |
||||||||
| Accounts payable |
$ |
1,957 |
$ |
1,243 |
||||
| Accrued expenses |
3,455 |
4,133 |
||||||
| Due to related parties |
30 |
30 |
||||||
| Notes and loans payable, current portion |
2,130 |
2,011 |
||||||
| Total current liabilities |
7,572 |
7,417 |
||||||
| Grants payable |
469 |
469 |
||||||
| Notes and loans payable, net of current portion |
963 |
1,564 |
||||||
| Deferred tax liability |
10,870 |
10,870 |
||||||
| Total liabilities |
19,874 |
20,320 |
||||||
| Commitments and contingencies |
||||||||
| Stockholders' Equity |
||||||||
| Series C Preferred stock, par value $0.0001; 15,000 shares authorized, 4,320 shares available for issuance, 2,792 and 2,832 shares issued and outstanding, as of March 31, 2015 and December 31, 2014, respectively |
809 |
821 |
||||||
| Undesignated preferred stock, par value $0.0001; 4,985,000 shares authorized, 4,981,935 shares available for issuance, none issued and outstanding, as of March 31, 2015 and December 31, 2014, respectively |
- |
- |
||||||
| Common stock, $0.0001 par value; authorized 225,000,000 shares; 24,573,009 and 23,975,358 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively |
2 |
2 |
||||||
| Additional paid-in capital |
63,995 |
62,550 |
||||||
| Accumulated deficit |
(49,385) |
(45,829) |
||||||
| Total stockholders' equity |
15,421 |
17,544 |
||||||
| Total liabilities and stockholders' equity |
$ |
35,295 |
$ |
37,864 |
||||
| Condensed Consolidated Statements of Operations |
|||||||||
| Three Months Ended March 31, |
|||||||||
| 2015 |
2014 |
||||||||
| Revenue: |
|||||||||
| Revenue |
$ |
- |
$ |
2 |
|||||
| Costs and expenses: |
|||||||||
| Research and development |
1,150 |
338 |
|||||||
| General and administrative |
2,303 |
2,541 |
|||||||
| Total costs and expenses |
3,453 |
2,879 |
|||||||
| Loss from operations |
(3,453) |
(2,877) |
|||||||
| Non-operating expense: |
|||||||||
| Interest expense |
(100) |
(152) |
|||||||
| Derivative liability expense |
- |
(1,683) |
|||||||
| Other expense |
(3) |
(67) |
|||||||
| Total non-operating expense: |
(103) |
(1,902) |
|||||||
| Net loss before income taxes |
(3,556) |
(4,779) |
|||||||
| Income tax expense |
- |
- |
|||||||
| Net loss |
(3,556) |
(4,779) |
|||||||
| Dividend on Series C Preferred Stock |
(56) |
- |
|||||||
| Loss attributable to common stockholders |
$ |
(3,612) |
$ |
(4,779) |
|||||
| Basic and diluted loss per common share |
$ |
(0.15) |
$ |
(0.35) |
|||||
| Weighted average common shares outstanding-basic and diluted |
24,320,372 |
13,515,828 |
|||||||
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: 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 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.
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 clinical trials for bertilimumab or AmiKet will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAb program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market 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; and risks associated with our ability to protect our intellectual property. 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.
SOURCE Immune Pharmaceuticals Inc.
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