BLUE BELL, Pa., May 9, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the quarter ended March 31, 2012.
Total revenue was $1.7 million for the three months ended March 31, 2012, compared to $3.1 million for the same period in 2011. Total operating expenses were $5.9 million compared to $7.5 million. The net loss attributable to common stockholders was $8.3 million, or $0.06 per share, compared to $2.4 million, or $0.02 per share.
Revenue The decrease in revenue for the comparable periods was primarily due to timing of work performed under the company's contract with the National Institute of Allergy and Infectious Diseases (NIAID). This contract revenue amounted to $1.5 million versus $2.7 million, respectively. This NIAID contract, which exceeds $23 million over five years (plus two additional option years), is facilitating Inovio's development of a universal, preventive HIV DNA vaccine, PENNVAX®-GP.
Operating Expenses Research and development expenses for Q1 2012 were $4.0 million compared to $4.4 million for Q1 2011. General and administrative expenses were $2.5 million versus $3.3 million, respectively.
Net Loss Attributable to Common Stockholders The $5.9 million increase in net loss for the comparable periods resulted primarily from a significant (non-cash) change in fair value of common stock warrants, based on a required quarterly mark to market adjustment to reflect changes in the Company's stock price, and decrease in grant revenue.
Capital Resources As of March 31, 2012, cash and cash equivalents plus short-term investments in certificates of deposit, mutual funds, and municipal bonds were $25.0 million compared with $30.3 million as of December 31, 2011.
Based on management's projections and analysis, the Company believes that cash and cash equivalents are sufficient to meet its planned working capital requirements into the third quarter of 2013.
Inovio's balance sheet and statement of operations is provided below. Form 10-Q providing the complete 2012 first quarter financial report can be found at: http://ir.inovio.com/secfilings.
Corporate UpdateClinical DevelopmentDuring the first quarter Inovio reported significant vaccine-specific T-cell responses from its HIV-001 open label, phase I study, which enrolled 12 adult HIV-positive volunteers to assess safety and levels of immune responses generated by Inovio's PENNVAX®-B vaccine delivered with its CELLECTRA® electroporation device. The results affirmed best-in-class immune responses reported last year from Inovio's HVTN-080 phase I study of PENNVAX-B in healthy volunteers.
Enrollment is ongoing in Inovio's phase II clinical study of VGX-3100 for cervical dysplasia. Data is expected in the second half of 2013. The company's collaborators, the University of Southampton and ChronTech Pharma AB, continue their enrollment of patients in phase II studies of DNA vaccines for leukemia and hepatitis C virus, respectively, with interim data anticipated in the second half of 2012.
We expect to report data from two phase I influenza studies, one for our synthetic vaccine focused on H5N1 influenza, the other for our synthetic universal vaccine targeting H5N1 and H1N1, in the second quarter.
Preclinical DevelopmentDuring the quarter we announced data from multiple research and preclinical programs.
Synthetic vaccines for influenza Type A H3N2 and Type B achieved protective antibody responses in immunized animals against multiple unmatched strains from the years 2000 through 2012, progressing our universal influenza vaccine strategy.
Inovio's new skin electroporation technology significantly enhanced delivery of small interfering RNA (siRNA) molecules to skin and also demonstrated gene knockdown (silencing) in animal studies.
Inovio's SynCon® therapeutic vaccine for human papillomavirus (HPV) types 6 and 11, associated with head & neck cancers and genital warts, induced strong antigen-specific CD8+ T cells in mice, mirroring robust T-cell responses induced by VGX-3100 in earlier mice studies.
Corporate & Business DevelopmentInovio received a patent covering its synthetic consensus influenza H1 antigen, which relates to our H1N1 influenza constructs and INO-3510 universal influenza vaccine.
Inovio was awarded a U.S. Department of Defense Small Business Innovation Research Grant to advance a low-cost, non-invasive surface electroporation delivery device and test its utility in combination with Inovio synthetic vaccines against viruses with bioterrorism potential.
Niranjan Y. Sardesai, Ph.D., was promoted to Chief Operating Officer and is now responsible for corporate and business development in addition to overseeing research and development.
Dr. Anthony Ford-Hutchinson, recently retired from his role as Senior Vice President, Vaccines Research and Development at Merck, joined Inovio's Scientific Advisory Board.
Dr. Adel Mahmoud was appointed to Inovio's Board of Directors. He is a professor at Princeton University, was President, Merck Vaccines, from 1999 to 2005, and also served as Merck's Chief Medical Advisor for Vaccines and Infectious Diseases.
Inovio has an expanding dialog with vaccine and biotechnology companies as well as non-governmental and government agencies with the goal of securing non-dilutive funding for its vaccine programs and potentially new collaborations and partnerships to advance the development and commercialization of its SynCon® vaccine platform and specific SynCon vaccines.
About Inovio Pharmaceuticals, Inc. Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include phase II studies for cervical dysplasia, leukemia and hepatitis C virus and phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2011, our Form 10-Q for the quarter ended March 31, 2012, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETSMarch 31,
2011(Unaudited)ASSETSCurrent assets:Cash and cash equivalents
467,909Accounts receivable from affiliated entity
38,406Prepaid expenses and other current assets
746,049Prepaid expenses and other current assets from affiliated entity
441,186Total current assets26,936,386
100,059Fixed assets, net
295,785Intangible assets, net
10,113,371Investment in affiliated entity
9,071,513Investment in common stock warrants
,106,561LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable and accrued expenses
4,318,942Accounts payable and accrued expenses due to affiliated entity
20,344Accrued clinical trial expenses
1,059,372Common stock warrants
79,502Deferred revenue from affiliated entity
388,542Total current liabilities13,014,987
11,043,021Deferred revenue, net of current portion
80,450Deferred revenue from affiliated entity, net of current portion
80,875Deferred tax liabilities
13,244,899Stockholders' equity:Inovio Pharmaceuticals, Inc. stockholders' equity:Common stock
134,968Additional paid-in capital
(210,091,174)Accumulated other comprehensive income
35,393Total Inovio Pharmaceuticals, Inc. stockholders' equity39,692,462
546,768Total stockholders' equity
47,861,662Total liabilities and stockholders' equity$
,106,561 INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)Three Months Ended
March 31,20122011Revenues:License fee and milestone revenue
26,368License fee and milestone revenue from affiliated entity106,250
93,750Grants and miscellaneous revenue1,562,033
3,105,265Operating expenses:Research and development4,042,579
4,421,799General and administrative2,488,088
3,319,232Gain on sale of assets
(250,000)Total operating expenses5,879,667
7,491,031Loss from operations(4,186,546)
(4,385,766)Other income (expense):Interest and other income, net
1,855Change in fair value of common stock warrants(3,548,173)
2,331,868Loss on investment in affiliated entity(561,544 )
(2,422,054)Net loss attributable to non-controlling interest9,770
9,441Net loss attributable to Inovio Pharmaceuticals, Inc.$ (8,254,949)
$ (2,412,613)Loss per common share — basic and diluted:Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders$
(0.02)Weighted average number of common shares outstanding — basic and diluted134,968,394
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101
Media: Jeff Richardson, Richardson & Associates, 805-491-8313
|SOURCE Inovio Pharmaceuticals, Inc.|
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