OREANDA-NEWS. Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today reported financial results for the quarter ended June 30, 2016. The following financial results provide a year-over-year comparison of the second quarter in 2016 and 2015. Total revenue was $6.2 million compared to $5.3 million. Total operating expenses were $24.4 million compared to $20.4 million. The net loss attributable to common stockholders was $18.7 million, or $0.26 per share, compared to $6.2 million, or $0.09 per share.

Revenue

The increase in revenue was primarily due to an increase in development payments from our DARPA Ebola grant.

Operating Expenses

Research and development expenses were $19.6 million compared to $16.7 million. The increase was primarily related to increased investment in our product development programs. General and administrative expenses were $5.8 million compared to $4.7 million.

Corporate Update

Clinical Development

  • The FDA and European Medicines Agency provided an affirmative path toward an indication for VGX-3100 to treat HPV-16/18-related high grade cervical dysplasia in a pivotal phase III registration study. We completed major commercial device design and manufacturing process development efforts, and are in the final stage of testing.  Completion of this extensive work will enable us to then submit our final package to the FDA in order to start the phase III in 4Q 2016.
  • Received approval from the FDA to initiate a phase I human trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). This phase I, open-label, dose-ranging study with 40 healthy subjects is evaluating the safety, tolerability and immunogenicity of GLS-5700. Subsequent to the quarter Inovio announced the dosing of the first subject in this study. We expect to report interim immune response and safety data in 4Q 2016.
  • Inovio will continue to develop its hepatitis B DNA immunotherapy (INO-1800) independently following Roche’s notice that it will discontinue its collaboration with Inovio and its development of INO-1800. INO-1800 was licensed to Roche from Inovio in 2013. All of Roche's rights to INO-1800, including the right to license the product to other parties, will be returned. Inovio will continue to advance its current phase I study of INO-1800, which is enrolling as planned in 30 clinical sites in the U.S. and Asia-Pacific regions. Inovio anticipates completing enrollment in the first half of 2017 and expects results in the second half of 2017.
    The study has completed interim safety reviews with a favorable safety profile to date. Immunology analyses are planned after completion of enrollment.
  • Partnered with the National Cancer Institute and Mayo Clinic to initiate a phase I trial of our immunotherapy for hepatitis C (INO-8000). The dose escalation study will enroll patients in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability.
  • Completed enrollment of 94 subjects in the phase I study of our PENNVAX®-GP HIV immunotherapy. After completing extensive immunogenicity analyses, we expect to report data in 1H 2017.
  • Completed enrollment of 22 subjects in the phase I study of our HPV-driven cancer immunotherapy, INO-3112, in head & neck cancer patients. We expect to report additional immune response and safety data in 4Q 2016.
  • Completed enrollment of 62 subjects in the phase I study of our INO-5150 prostate cancer immunotherapy. We expect to report interim immune response and safety data in 4Q 2016.
  • Completed enrollment of 75 subjects in the phase I study of our GLS-5300 MERS vaccine.  We expect to report interim immune response and safety data in 4Q 2016.

Corporate Development

  • Inovio completed the acquisition of all of Bioject Medical Technologies Inc.’s assets, including pioneering needle-free jet injection technology, devices, and intellectual property, for $5.5 million in cash and stock.
  • Inovio’s DNA-based monoclonal antibody technology will be deployed to develop new immunotherapy approaches to treat HIV. This work will be funded by a $23 million grant, called BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy, from the National Institutes of Health to The Wistar Institute, an Inovio collaborator, and more than 30 of the nation's leading HIV investigators.

Preclinical Development

  • Preclinical testing of our Zika virus synthetic vaccine induced robust and durable immune responses in mice and in non-human primates (monkeys).

About Inovio Pharmaceuticals, Inc.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University.

 
Inovio Pharmaceuticals, Inc.
CONSOLIDATED BALANCE SHEETS
 
  June 30,
 2016		   December 31,
 2015
  (Unaudited)    
ASSETS      
Current assets:      
Cash and cash equivalents $ 28,450,373     $ 57,632,693  
Short-term investments 106,082,989     105,357,277  
Accounts receivable 10,365,950     7,333,059  
Prepaid expenses and other current assets 1,188,042     917,257  
Prepaid expenses and other current assets from affiliated entity 1,882,257     610,652  
Total current assets 147,969,611     171,850,938  
Fixed assets, net 8,700,628     7,306,695  
Investment in affiliated entity- GeneOne 21,716,728     14,941,277  
Investment in affiliated entity - PLS 5,309,488     5,045,915  
Intangible assets, net 8,449,306     3,905,860  
Goodwill 10,513,371     10,113,371  
Other assets 1,326,317     676,803  
Total assets $ 203,985,449     $ 213,840,859  
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable and accrued expenses $ 12,707,754     $ 13,064,899  
Accounts payable and accrued expenses due to affiliated entity 600,969     165,047  
Accrued clinical trial expenses 5,006,287     2,600,483  
Common stock warrants 1,815,343     1,301,138  
Deferred revenue 14,502,626     13,449,768  
Deferred revenue from affiliated entity 469,792     504,442  
Deferred rent 391,913     380,629  
Total current liabilities 35,494,684     31,466,406  
Deferred revenue, net of current portion 374,043     103,074  
Deferred revenue from affiliated entity, net of current portion 274,194     677,371  
Deferred rent, net of current portion 5,576,953     5,485,313  
Deferred tax liabilities 175,642     175,642  
Total liabilities 41,895,516     37,907,806  
Inovio Pharmaceuticals, Inc. stockholders’ equity:      
Common stock 73,483     72,218  
Additional paid-in capital 546,251,246     534,004,564  
Accumulated deficit (387,845,427 )   (361,097,896 )
Accumulated other comprehensive income 3,514,362     2,708,339  
Total Inovio Pharmaceuticals, Inc. stockholders’ equity 161,993,664     175,687,225  
Non-controlling interest 96,269     245,828  
Total stockholders’ equity 162,089,933     175,933,053  
Total liabilities and stockholders’ equity $ 203,985,449     $ 213,840,859  
Inovio Pharmaceuticals, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
  Three Months Ended
June 30,		   Six Months Ended
June 30,
  2016   2015   2016   2015
Revenues:              
Revenue under collaborative research and development arrangements $ 1,889,988     $ 4,335,236     $ 3,686,845     $ 8,580,807  
Revenue under collaborative research and development arrangements with affiliated entity 499,720     166,667     636,720     279,167  
Grants and miscellaneous revenue 3,814,083     784,775     9,990,381     1,593,341  
Total revenues 6,203,791     5,286,678     14,313,946     10,453,315  
Operating expenses:              
Research and development 19,630,801     16,688,511     37,819,961     26,114,831  
General and administrative 5,799,530     4,718,260     11,171,143     8,826,188  
Gain on sale of assets (1,000,000 )   (1,000,000 )   (1,000,000 )   (1,000,000 )
Total operating expenses 24,430,331     20,406,771     47,991,104     33,941,019  
Loss from operations (18,226,540 )   (15,120,093 )   (33,677,158 )   (23,487,704 )
Other income (expense):              
Interest and other income, net 341,131     146,332     674,201     284,608  
Change in fair value of common stock warrants, net (113,775 )   (49,773 )   (520,024 )   (51,000 )
Gain (loss) on investment in affiliated entity (705,527 )   8,861,145     6,775,450     6,508,836  
Net loss (18,704,711 )   (6,162,389 )   (26,747,531 )   (16,745,260 )
Net loss attributable to non-controlling interest —     (85,861 )   —     (84,769 )
Net loss attributable to Inovio Pharmaceuticals, Inc. $ (18,704,711 )   $ (6,248,250 )   $ (26,747,531 )   $ (16,830,029 )
Net loss per common share attributable to Inovio Pharmaceuticals, Inc. stockholders:              
Basic $ (0.26 )   $ (0.09 )   $ (0.37 )   $ (0.26 )
Diluted $ (0.26 )   $ (0.09 )   $ (0.37 )   $ (0.27 )
Weighted average number of common shares outstanding used in per share calculations:              
Basic 72,957,159     67,655,975     72,591,986     64,198,528  
Diluted 72,957,159     67,838,738     72,591,986     64,376,523