BLUE BELL, Pa., March 18, 2013 /PRNewswire/ --Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the fourth quarter and year ended December 31, 2012.
Total revenue was $1.1 million and $4.1 million for the quarter and year ended December 31, 2012, compared to $1.6 million and $9.8 million for the same periods in 2011.
Total operating expenses for the quarter and year and ended December 31, 2012, were $7.4 million and $27.6 million as compared to $7.4 million and $31.4 million for the same periods in 2011.
The net loss attributable to common stockholders for the quarter and year ended December 31, 2012, was $659,000, or $0.00 per share, and $19.7 million, or $0.14 per share, as compared with a net loss attributable to common stockholders of $5.5 million, or $0.04 per share, and $15.3 million, or $0.12 per share, for the quarter and year ended December 31, 2011.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "In 2012 our DNA vaccines achieved two vital breakthroughs in human studies: best-in-class therapeutic immune responses displayed the desired killing effect against a targeted disease; broadly targeted universal vaccines generated protective immune responses against multiple unmatched strains of a pathogen. These were scientific firsts. Our current funding will carry us through additional important milestones, including efficacy data from our cervical dysplasia phase II study in Q1 2014."
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 $671,000 and $2.8 million for the quarter and year ended December 31, 2012, versus $1.4 million and $7.8 million for the same periods in 2011. This NIAID contract, which provides up to $25.3 million of funding over seven years, is facilitating Inovio's development of a universal, preventive HIV DNA vaccine, PENNVAX®-GP.
Operating Expenses
Research and development expenses for the quarter and year ended December 31, 2012, were $4.4 million and $18.0 million as compared to $4.2 million and $20.0 million for the same periods in 2011. General and administrative expenses for the quarter and year ended December 31, 2012, were $2.9 million and $10.8 million, compared to $3.3 million and $12.0 million for the quarter and year ended December 31, 2011.
Net Loss Attributable to Common Stockholders
The $4.4 million increase in net loss attributable to common stockholders for the year ended December 31, 2012, compared with the year ended 2011 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, the change in fair market value of our investment in VGX International, and a decrease in grant revenue.
Capital Resources
During the year ended December 31, 2012, the Company sold 9,344,611 shares of common stock under its ATM common stock sales agreement for net proceeds of $5.3 million.
As of December 31, 2012, cash and cash equivalents plus short-term investments in certificates of deposit, mutual funds, and municipal bonds were $13.8 million compared with $30.3 million as of December31, 2011.
Subsequent to year end, the Company sold 8,222,966 shares of common stock under its ATM common stock sales agreement for net proceeds of $5.6 million.
On March7, 2013, we closed an underwritten offering of 27,377,266 shares of our common stock and warrants to purchase an aggregate of up to 13,688,633 shares of common stock. The shares and warrants were sold in units at a price of $0.55 per unit, with each unit consisting of one share of common stock and a warrant to purchase 0.50 shares of common stock at an exercise price of $0.7936 per share. The warrants have a term of five and one-half years. The net proceeds, after deducting the underwriters' discounts and other estimated offering expenses, and assuming no exercise of the warrants, were approximately $14.0 million.
Based on management's projections and analysis, the Company believes that current cash and cash equivalents plus short-term investments are sufficient to meet its planned working capital requirements through 2014.
Inovio's balance sheet and statement of operations are provided below. Form 10-K providing the complete 2012 annual financial report can be found at: http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
Inovio's mission is to revolutionize vaccines by achieving critical capabilities: using synthetic non-replicating vaccines to not only prevent but treat cancers and infectious diseases, including enabling universal protection against multiple unmatched pathogen strains. In 2012, we reported important scientific and clinical breakthroughs on these fronts.
With respect to the treatment potential of our novel synthetic vaccines, we reported significant antigen-specific T-cell responses from our HIV-001 phase I study, which enrolled 12 adult HIV-positive volunteers to assess our PENNVAX®-B vaccine delivered with electroporation. These results affirmed best-in-class immune responses reported in 2011 from Inovio's HVTN-080 48-patient phase I study of PENNVAX-B in healthy volunteers.
We also reported that our SynCon® vaccine against cervical dysplasias/cancers (VGX-3100) achieved an industry first when T-cell immune responses induced by this vaccine, which have been previously reported as being best-in-class, were shown to generate a strong killing effect against cells targeted by this vaccine. Based on our advanced patient enrollment, we expect unblinded data from this 148-patient Phase II clinical trial in 1Q 2014.
With respect to the universal prevention capability of our vaccine platform, we reported that in a 60-patient phase I study our H1N1 influenza vaccine generated protective immune responses against the nine key H1N1 flu strains of the past 100 years, including the 1918 pandemic flu strain. None of these viruses were matched to the vaccine. These results added to previously reported results in which our H5N1 (avian) influenza vaccine construct generated significant immune responses against six different unmatched strains of H5N1 in a 17-patient phase I study. Together these results represent an industry first and an important step toward universal preventive and/or therapeutic capabilities against mutating pathogens as well as for cancers.
In 4Q, we reported interim results (two of three arms) of a 50-patient phase I trial showing that a single dose of our H1N1 universal SynCon® flu vaccine followed by a dose of a seasonal flu vaccine generated protective immune responses in 40% of trial subjects compared with a 20% response rate in elderly patients who received the seasonal flu vaccine alone.
We reported preliminary results of a phase II clinical trial, conducted by our collaborator University of Southampton, to treat leukemia with a DNA vaccine delivered with our proprietary electroporation delivery system. The data showed robust vaccine-specific antibody responses in all vaccinated subjects evaluated to date. T-cell immune responses, including "killer T-cells," were detected.
We expect to report in 1Q 2013 interim data of a phase II clinical trial, conducted by our collaborator ChronTech Pharma AB, treating hepatitis C virus with a DNA vaccine delivered with our proprietary electroporation delivery system in conjunction with a drug regimen.
Preclinical Development
Inovio announced that synthetic vaccines for influenza Type A H3N2 and Type B achieved protective levels of antibody responses in immunized animals against multiple unmatched strains from the years 2000 through 2012. Inovio intends to combine these two subtypes with its H1N1 SynCon® construct to create a universal vaccine intended to provide broad protection against existing and changing seasonal and pandemic influenza strains.
We reported that our synthetic hepatitis B therapeutic vaccine generated strong T cell responses that eliminated targeted liver cells in mice. These data were published in the peer-reviewed journal,Cancer Gene Therapy.
Our testing of multiple synthetic vaccine constructs for cytomegalovirus (CMV) induced robust T cells in mice. CMV is the most common viral infection in organ transplant recipients, is associated with cerebral palsy, brain tumors, numerous inflammatory diseases and cancers, and is implicated in hypertension. These data were published in the peer-reviewed journal,Human Vaccines & Immunotherapeutics.
Inovio scientists and collaborators demonstrated in animal models that optimized electroporation (EP) parameters of our new minimally invasive skin (intradermal) EP delivery devices using decreased current could generate stronger antibody and T cell responses to HIV and flu vaccine antigens in both guinea pigs and monkeys.These newly published optimized conditions, which enhance this delivery system as an attractive method for mass vaccination, appeared in the peer-reviewed journal,Human Gene Therapy.
Corporate Development
Inovio continues to advance discussions with large pharmaceutical companies with the goal of securing strategic partnerships to advance the development of SynCon® vaccines.
In 2012 Inovio expanded its existing license agreement with the University of Pennsylvania with worldwide rights to technology and intellectual property for novel synthetic vaccines against C. difficile (intestinal infections), Wilms' tumor gene (leukemia and various solid tumor types), and Ebola virus and the family of Filovirus such as Marburg (which could potentially be used in bioterror attacks).
Inovio received U.S. patents covering its synthetic consensus influenza H1 and cervical dysplasia/cancer SynCon® DNA vaccine constructs, adding to its patent estate of more than 400 worldwide granted and pending patents.
We were 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.
Our VGX Animal Health subsidiary reported advancements for its growth hormone releasing hormone (GHRH) treatment focused on enhancing health and food production efficiency of farm animals. Previously approved in Australia, the Company was granted marketing approval in New Zealand for its high-dose plasmid therapy. The Company also reported that its new low-dose version of this therapy, LifeTide® SW 1.0, resulted in more live pigs per litter and higher birth and weaning weights.
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 Form10-K for the year ended December31, 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. | |||||||
CONSOLIDATED BALANCE SHEETS | |||||||
December31, | |||||||
2012 | 2011 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 5,646,021 | $ | 17,350,116 | |||
Short-term investments | 8,034,001 | 12,863,420 | |||||
Accounts receivable | 830,433 | 467,909 | |||||
Accounts receivable from affiliated entity | 36,234 | 38,406 | |||||
Prepaid expenses and other current assets | 471,328 | 746,049 | |||||
Prepaid expenses and other current assets from affiliated entity | 887,167 | 441,186 | |||||
Deferred tax asset | 62,728 | - | |||||
Total current assets | 15,967,912 | 31,907,086 | |||||
Restricted cash | 100,410 | 100,059 | |||||
Fixed assets, net | 363,021 | 295,785 | |||||
Investment in affiliated entity | 10,703,332 | 9,071,513 | |||||
Intangible assets, net | 7,489,315 | 9,310,485 | |||||
Goodwill | 10,113,371 | 10,113,371 | |||||
Common stock warrants | 267,200 | 100,000 | |||||
Other assets | 134,193 | 208,262 | |||||
Total assets | $ | 45,138,754 | $ | 61,106,561 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 3,181,574 | $ | 4,318,942 | |||
Accounts payable and accrued expenses due to affiliated entity | 187,275 | 20,344 | |||||
Accrued clinical trial expenses | 1,405,896 | 1,059,372 | |||||
Common stock warrants | 2,859,899 | 5,176,319 | |||||
Deferred revenue | 353,391 | 79,502 | |||||
Deferred revenue from affiliated entity | 388,542 | 388,542 | |||||
Total current liabilities | 8,376,577 | 11,043,021 | |||||
Deferred revenue, net of current portion | 88,609 | 80,450 | |||||
Deferred revenue from affiliated entity, net of current portion | 1,586,694 | 1,961,694 | |||||
Deferred rent | 65,076 | 80,875 | |||||
Deferred tax liabilities | 164,393 | 78,859 | |||||
Total liabilities | 10,281,349 | 13,244,899 | |||||
Commitments and contingencies | |||||||
Inovio Pharmaceuticals, Inc. stockholders' equity: | |||||||
Preferred stock-par value $0.001; Authorized shares: 10,000,000, issued and outstanding: 26 and 26 at December31, 2012 and December31, 2011, respectively | - | - | |||||
Common stock-par value $0.001; Authorized shares: 300,000,000, issued and outstanding: 144,313,005 at December31, 2012 and 134,968,394 at December31, 2011 | 144,313 | 134,968 | |||||
Additional paid-in capital | 263,897,116 | 257,235,707 | |||||
Accumulated deficit | (229,760,129) | (210,091,174) | |||||
Accumulated other comprehensive income | 73,362 | 35,393 | |||||
Total Inovio Pharmaceuticals, Inc. stockholders' equity | 34,354,662 | 47,314,894 | |||||
Non-controlling interest | 502,743 | 546,768 | |||||
Total stockholders' equity | 34,857,405 | 47,861,662 | |||||
Total liabilities and stockholders' equity | $ | 45,138,754 | $ | 61,106,561 | |||
Inovio Pharmaceuticals, Inc. | |||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
For the Years ended December31, | |||||||||||
2012 | 2011 | 2010 | |||||||||
Revenues: | |||||||||||
License fee and milestone revenue | $ | 82,536 | $ | 156,397 | $ | 213,916 | |||||
License fee and milestone revenue from affiliated entity | 425,000 | 411,459 | 313,306 | ||||||||
Revenue under collaborative research and development arrangements with affiliated entity | 152,467 | - | - | ||||||||
Grants and miscellaneous revenue | 3,458,649 | 9,227,401 | 5,549,583 | ||||||||
Miscellaneous revenue from affiliated entity | - | - | 67,900 | ||||||||
Total revenues | 4,118,652 | 9,795,257 | 6,144,705 | ||||||||
Operating expenses: | |||||||||||
Research and development | 17,984,825 | 20,032,001 | 13,256,606 | ||||||||
General and administrative | 10,778,359 | 11,988,796 | 12,108,261 | ||||||||
Gain on sale of assets | (1,151,000) | (587,000) | - | ||||||||
Total operating expenses | 27,612,184 | 31,433,797 | 25,364,867 | ||||||||
Loss from operations | (23,493,532) | (21,638,540) | (19,220,162) | ||||||||
Other income (expense): | |||||||||||
Interest and other income, net | 166,113 | 34,285 | 147,406 | ||||||||
Change in fair value of common stock warrants | 1,982,620 | 8,690,658 | 2,403,924 | ||||||||
Gain (Loss) on investment in affiliated entity | 1,631,819 | (2,390,498) | (969,914) | ||||||||
Net loss | (19,712,980) | (15,304,095) | (17,638,746) | ||||||||
Net loss attributable to non-controlling interest | 44,025 | 51,150 | 24,950 | ||||||||
Net loss attributable to Inovio Pharmaceuticals, Inc. | $ | (19,668,955) | $ | (15,252,945) | $ | (17,613,796) | |||||
Loss per common share-basic and diluted: | |||||||||||
Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders | $ | (0.14) | $ | (0.12) | $ | (0.17) | |||||
Weighted average number of common shares outstanding-basic and diluted | 136,509,247 | 126,239,336 | 103,201,880 | ||||||||
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211
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SOURCE Inovio Pharmaceuticals, Inc.
