Inovio Pharmaceuticals Reports 2012 Second Quarter Financial Results

BLUE BELL, Pa., Aug. 9, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today reported financial results for the quarter ended June 30, 2012.

Total revenue was $436,000 and $2.1 million for the three and six months ended June 30, 2012, compared to $2.4 million and $5.5 million for the same periods in 2011.

Total operating expenses were $7.2 million and $13.1 million for the three and six months ended June 30, 2012, compared to $7.6 million and $15.0 million for the same periods in 2011.

The net loss attributable to common stockholders for the three and six months ended June 30, 2012, was $4.1 million, or $0.03 per share, and $12.4 million, or $0.09 per share, as compared with a net loss attributable to common stockholders of $2.8 million, or $0.02 per share, and $5.2 million, or $0.04 per share, for the three and six months ended June 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 $234,000 and $1.7 million for the three and six months ended June 30, 2012, versus $1.7 million and $4.5 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 six months ended June 30, 2012, were $4.5 million and $8.6 million for the three and six months ended June 30, 2012 as compared to $4.5 million and $8.9 million for the same periods in 2011. General and administrative expenses for the three and six months ended June 30, 2012 were $2.7 million and $5.2 million versus $3.1 million and $6.4 million for the same periods in 2011.

Net Loss Attributable to Common Stockholders

The $1.3 million and $7.2 million increase in net loss for the three and six months ended June 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 June 30, 2012, cash and cash equivalents plus short-term investments in certificates of deposit, mutual funds, and municipal bonds were $19.5 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 quarter, Inovio replaced a prior ATM agreement that the Company already had in place with a sales agreement with Cowen and Company, LLC, under which Inovio may from time to time offer and sell common stock with aggregate proceeds of up to $25 million. Inovio may sell its stock through Cowen by methods deemed to be an "at the market" offering (ATM), including sales made through the NYSE MKT or any other existing trading market for the common stock or to or through a market maker.

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

Corporate Update

Clinical Development

During the second quarter, Inovio reported that its SynCon® avian influenza vaccine generated protective HAI titers against six different unmatched strains of H5N1 in a phase I clinical trial - a distinct clinical achievement on Inovio's path to develop universal influenza vaccines.

Subsequent to the quarter, Inovio treated the first patients in a clinical trial evaluating immune responses in elderly adults immunized with Inovio's H1N1 SynCon® universal influenza vaccine. This phase I study will evaluate the ability of Inovio's SynCon® vaccine alone as well as in combination with the 2012 seasonal influenza vaccine to generate: protective levels of immune responses; antigen-specific antibody immune responses against unmatched influenza strains; and T-cell immune responses that may be helpful in fighting influenza. The 65+ age group represents about 90% of annual influenza deaths in the US.

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. 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 year end.

Corporate & Business Development

During the second quarter Inovio added to its patent estate of more than 400 worldwide granted and pending patents with two newly granted U.S. patents covering its SynCon® vaccine for cervical dysplasias and cancers caused by human papillomavirus (HPV) as well as its universal vaccine related to H1N1 influenza.

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.

Inovio appointed to its Board of Directors an international business management expert, Angel Cabrera, Ph.D., who is president of George Mason University, the largest university in Virginia and former president of the Thunderbird School of Global Management, widely regarded as the world's leading graduate school of international business.

Inovio is advancing discussions with large pharmaceutical companies with the goal of securing new partnerships to advance the development and commercialization of its 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, 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 June 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.

 

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS





June 30,

2012

December 31,

2011


(Unaudited)


ASSETS



Current assets:



Cash and cash equivalents

$            5,952,143

$          17,350,116

Short-term investments

13,487,062

12,863,420

Accounts receivable

432,108

467,909

Accounts receivable from affiliated entity

33,446

38,406

Prepaid expenses and other current assets

598,482

746,049

Prepaid expenses and other current assets from affiliated entity

813,935

441,186




Total current assets

21,317,176

31,907,086

Restricted cash

100,234

100,059

Fixed assets, net

421,519

295,785

Intangible assets, net

8,393,119

9,310,485

Goodwill

10,113,371

10,113,371

Investment in affiliated entity

7,517,596

9,071,513

Investment in common stock warrants

509,800

100,000

Other assets

223,056

208,262




Total assets

$          48,595,871

$          61,106,561




LIABILITIES AND STOCKHOLDERS' EQUITY



Current liabilities:



Accounts payable and accrued expenses

$            3,522,672

$            4,318,942

Accounts payable and accrued expenses due to affiliated entity

53,613

20,344

Accrued clinical trial expenses

1,160,643

1,059,372

Common stock warrants

5,038,510

5,176,319

Deferred revenue

41,864

79,502

Deferred revenue from affiliated entity

413,542

388,542




Total current liabilities

10,230,844

11,043,021

Deferred revenue, net of current portion

77,643

80,450

Deferred revenue from affiliated entity, net of current portion

1,774,194

1,961,694

Deferred rent

75,224

80,875

Deferred tax liabilities

78,859

78,859




Total liabilities

12,236,764

13,244,899




Stockholders' equity:



Inovio Pharmaceuticals, Inc. stockholders' equity:



Common stock

134,968

134,968

Additional paid-in capital

258,113,218

257,235,707

Accumulated deficit

(222,479,302)

(210,091,174)

Accumulated other comprehensive income

64,514

35,393




Total Inovio Pharmaceuticals, Inc. stockholders' equity

35,833,398

47,314,894

Non-controlling interest

525,709

546,768




Total stockholders' equity

36,359,107

47,861,662




Total liabilities and stockholders' equity

$          48,595,871

$          61,106,561




 

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)







Three Months Ended

June  30,

Six Months Ended

June  30,


2012

2011

2012

2011

Revenues:





License fee and milestone revenue

$                20,907

$                26,456

$                45,745

$                52,824

License fee and milestone revenue from affiliated

entity

106,250

105,208

212,500

198,958

Grant and miscellaneous revenue

308,925

2,288,099

1,870,958

5,273,246






Total revenues

436,082

2,419,763

2,129,203

5,525,028






Operating expenses:





Research and development

4,527,086

4,463,978

8,569,665

8,885,777

General and administrative

2,696,909

3,092,386

5,184,997

6,411,618

Gain on sale of assets

(651,000)

(250,000)






Total operating expenses

7,223,995

7,556,364

13,103,662

15,047,395






Loss from operations

(6,787,913)

(5,136,601)

(10,974,459)

(9,522,367)

Other income (expense):





Interest and other income, net

41,036

7,799

72,580

9,654

Change in fair value of common stock warrants

3,594,782

4,898,758

46,609

7,230,626

Loss from investment in affiliated entity

(992,373)

(2,607,227)

(1,553,917)

(2,977,238)






Net loss

(4,144,468)

(2,837,271)

(12,409,187)

(5,259,325)

Net loss attributable to non-controlling interest

11,289

15,112

21,059

24,553






Net loss attributable to Inovio Pharmaceuticals,

Inc.

$        (4,133,179)

$          (2,822,159)

$      (12,388,128)

$          (5,234,772)






Loss per common share — basic and diluted:





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

$                   (0.03)

$                   (0.02)

$                 (0.09)

$                   (0.04)






Weighted average number of common shares outstanding — basic and diluted

134,968,394

127,256,364

134,968,394

124,124,645







CONTACTS:


Investors: 

Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101

Media: 

Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211

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

SOURCE Inovio Pharmaceuticals, Inc.