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Nov 7 2012

BLUE BELL, Pa., Nov. 7, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the quarter ended September 30, 2012.

Total revenue was $855,000 and $3.0 million for the three and nine months ended September 30, 2012, compared to $2.6 million and $8.2 million for the same periods in 2011.

Total operating expenses were $7.1 million and $20.3 million for the three and nine months ended September 30, 2012, compared to $9.0 million and $24.0 million for the same periods in 2011.

The net loss attributable to common stockholders for the three and nine months ended September 30, 2012, was $6.6 million, or $0.05 per share, and $19.0 million, or $0.14 per share, compared to a net loss of $4.5 million, or $0.04 per share, and $9.8 million, or $0.08 per share, for the three and nine months ended September 30, 2011.

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 $453,000 and $2.2 million for the three and nine months ended September 30, 2012, versus $1.9 million and $6.4 million for the same periods in 2011. 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 the three and nine months ended September 30, 2012, were $5.0 million and $13.5 million for the three and nine months ended September 30, 2012, compared to $7.0 million and $15.9 million for the same periods in 2011. General and administrative expenses for the three and nine months ended September 30, 2012, were $2.7 million and $7.9 million versus $2.3 million and $8.7 million for the same periods in 2011.

Net Loss Attributable to Common Stockholders

The $2.1 million and $9.2 million increase in net loss for the three and nine months ended September 30, 2012, respectively, compared with the same periods in 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, and a decrease in grant revenue.

Capital Resources

As of September 30, 2012, cash and cash equivalents plus short-term investments in certificates of deposit, mutual funds, and municipal bonds were $15.2 million compared with $30.3 million as of December 31, 2011.

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 into the third quarter of 2013.

During the third quarter, the Company sold 2,086,986 shares of common stock under its ATM common stock sales agreement for net proceeds of $1.2 million.

Inovio's balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2012 third quarter financial report can be found at: http://ir.inovio.com/secfilings.

Corporate Update

Clinical Development

Inovio's mission is to revolutionize vaccines by achieving two critical capabilities: enabling vaccines to provide not only preventive but treatment capabilities; and enabling universal protection against multiple known and unknown strains rather than just a single known virus strain in order to provide better protection against mutating virus strains. During the third quarter, Inovio reported important scientific and clinical breakthroughs on both fronts.

With respect to the treatment potential of its novel synthetic vaccines, Inovio reported that its SynCon® vaccine against cervical dysplasias and 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 also shown to generate a strong killing effect against cells targeted by this vaccine. Enrollment is ongoing in Inovio's phase II clinical study of VGX-3100 for cervical dysplasia. Data is expected in late 2013.

Two Inovio collaborators, the University of Southampton and ChronTech Pharma AB, are expected to report interim data from their phase II studies of DNA vaccines for leukemia and hepatitis C virus, respectively, before the end of 2012. Both of these vaccines are also designed to generate T-cell responses to provide therapeutic benefits.

With respect to the universal prevention capability of its vaccine platform, Inovio reported that its H1N1 influenza vaccine "construct" generated protective immune responses in humans 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 the Q2 reported results in which Inovio's H5N1 (avian) influenza vaccine construct generated significant immune responses against six different unmatched strains of H5N1 in a human clinical trial. Together these results also represent an industry first and a major stride toward universal vaccines for influenza as well as other rapidly changing viruses such as HIV. Inovio expects to report additional data from the H1N1 study in 1Q 2013.

Inovio also treated the first patients in its third influenza clinical trial, this one evaluating immune responses in elderly adults immunized with Inovio's H1N1 SynCon® universal influenza vaccine. The 65+ age group represents about 90% of annual influenza deaths in the US. Interim data from this study is expected in the first half of 2013.

Corporate & Business Development

Inovio continues to advance discussions with large pharmaceutical companies with the goal of securing strategic partnerships to advance the development of SynCon® vaccines.

Inovio's VGX Animal Health subsidiary reported advancements for its growth hormone releasing hormone (GHRH) treatment focused on enhancing the health and food production efficiency of farm animals. The Company was granted marketing approval in New Zealand for its high-dose plasmid therapy that increases live births in pigs. This therapy was previously approved in Australia. 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.

Inovio Pharmaceuticals was also named Best Mid-Stage Product Development Company by the Philadelphia Business Journal.

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, our ability to secure new partnerships and collaborations, 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 September 30, 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.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211

 

 

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS






September 30,

2012


December 31,

2011


(Unaudited)



ASSETS




Current assets:




Cash and cash equivalents

$            4,588,658


$          17,350,116

Short-term investments

10,554,966


12,863,420

Accounts receivable

481,447


467,909

Accounts receivable from affiliated entity

134,320


38,406

Prepaid expenses and other current assets

487,721


746,049

Prepaid expenses and other current assets from affiliated entity

686,626


441,186





Total current assets

16,933,738


31,907,086

Restricted cash

100,323


100,059

Fixed assets, net

391,527


295,785

Intangible assets, net

7,939,741


9,310,485

Goodwill

10,113,371


10,113,371

Investment in affiliated entity

8,253,717


9,071,513

Investment in common stock warrants

520,600


100,000

Other assets

223,056


208,262





Total assets

$          44,476,073


$          61,106,561





LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued expenses

$            3,133,620


$            4,318,942

Accounts payable and accrued expenses due to affiliated entity

110,101


20,344

Accrued clinical trial expenses

1,384,462


1,059,372

Common stock warrants

6,162,948


5,176,319

Deferred revenue

84,146


79,502

Deferred revenue from affiliated entity

401,042


388,542





Total current liabilities

11,276,319


11,043,021

Deferred revenue, net of current portion

90,271


80,450

Deferred revenue from affiliated entity, net of current portion

1,680,444


1,961,694

Deferred rent

70,023


80,875

Deferred tax liabilities

78,859


78,859





Total liabilities

13,195,916


13,244,899





Stockholders' equity:




Inovio Pharmaceuticals, Inc. stockholders' equity:




Common stock

137,055


134,968

Additional paid-in capital

259,636,082


257,235,707

Accumulated deficit

(229,101,378)


(210,091,174 )

Accumulated other comprehensive income

93,102


35,393





Total Inovio Pharmaceuticals, Inc. stockholders' equity

30,764,861


47,314,894

Non-controlling interest

515,296


546,768





Total stockholders' equity

31,280,157


47,861,662





Total liabilities and stockholders' equity

$          44,476,073


$          61,106,561





 

 

 

INOVIO PHARMACEUTICALS, INC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)









Three Months Ended

September 30,



Nine Months Ended
September 30,



2012


2011



2012


2011

Revenues:










License fee and milestone revenue

$

22,495

$

76,888


$

68,240

$

129,712

License fee and milestone revenue from affiliated entity


106,250


106,250



318,750


305,208

Revenue under collaborative research and development arrangements with affiliated entity


116,234




116,234


Grant and miscellaneous revenue


609,717


2,454,423



2,480,675


7,727,669

Total revenues


854,696


2,637,561



2,983,899


8,162,589

Operating expenses










Research and development


4,972,319


6,987,824



13,541,984


15,873,601

General and administrative


2,674,362


2,323,188



7,859,359


8,734,806

Gain on sale of assets


(500,000)


(337,000)



(1,151,000)


(587,000)

Total operating expenses


7,146,681


8,974,012



20,250,343


24,021,407

Loss from operations


(6,291,985)


(6,336,451)



(17,266,444)


(15,858,818)

Other income (expense)










Interest and other income, net


37,013


5,738



109,593


15,392

Changes in fair value of common stock warrants


(1,113,638)


346,956



(1,067,029)


7,577,582

Gain (Loss) from investment in affiliated entity


736,121


1,427,176



(817,796)


(1,550,062)

Net loss


(6,632,489)


(4,556,581)



(19,041,676)


(9,815,906)

Net loss attributable to non-controlling interest


10,413


14,649



31,472


39,202

Net loss attributable to Inovio Pharmaceuticals, Inc.

$

(6,622,076)

$

(4,541,932)


$

(19,010,204)

$

(9,776,704)

Loss per common share — basic and diluted










Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders.

$

(0.05)

$

(0.04)


$

(0.14)

$

(0.08)

Weighted average number of common shares outstanding — basic and diluted


135,389,308


127,256,907



135,108,699


125,184,087

 

(Logo: http://photos.prnewswire.com/prnh/20120131/LA44118LOGO)

SOURCE Inovio Pharmaceuticals, Inc.



RELATED LINKS
http://www.inovio.com

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