UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-Q
xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 20182019
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM                     TO                     
COMMISSION FILE NO. 001-14888
 
 INOVIO PHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 33-0969592
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification No.)
   
660 W. GERMANTOWN PIKE, SUITE 110
PLYMOUTH MEETING, PA

 19462
(Address of principal executive offices) (Zip Code)
REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE: (267) 440-4200
SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT:
N/A
COMMON STOCK, $0.001 PAR VALUENasdaq Global Select Market
(Title of Class)(Name of Each Exchange on Which Registered)
SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE ACT: NONE(Former name, former address and former fiscal year, if changed since last report)
 

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par valueINOThe Nasdaq Stock Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x  No    ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer Accelerated filerx
     
Non-accelerated filer(Do not check if a smaller reporting company)Smaller reporting company
     
   Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ☐    No  x


The number of shares outstanding of the Registrant’s Common Stock, $0.001 par value, was 91,496,83599,027,772 as of August 3, 2018.5, 2019.
 


INOVIO PHARMACEUTICALS, INC.
FORM 10-Q

For the Quarterly Period Ended June 30, 20182019

INDEX
 
  




Part I. Financial Information

Item 1.    Financial Statements

INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30,
2018
 December 31,
2017
June 30,
2019
 December 31,
2018
(Unaudited)  (Unaudited)  
ASSETS      
Current assets:      
Cash and cash equivalents$15,085,643
 $23,786,579
$19,735,943
 $23,693,633
Short-term investments80,509,364
 103,638,844
86,235,815
 57,538,852
Accounts receivable1,712,962
 6,003,205
130,230
 3,316,361
Accounts receivable from affiliated entities960,453
 486,619
996,936
 738,583
Prepaid expenses and other current assets1,785,081
 2,600,906
2,309,362
 1,406,590
Prepaid expenses and other current assets from affiliated entities1,787,297
 1,846,007
1,100,746
 1,120,805
Total current assets101,840,800
 138,362,160
110,509,032
 87,814,824
Fixed assets, net16,868,953
 18,320,176
14,265,951
 15,949,014
Investment in affiliated entity - GeneOne9,014,490
 9,069,401
6,324,766
 6,381,926
Investment in affiliated entity - PLS2,667,805
 2,325,079
2,157,832
 3,023,987
Intangible assets, net5,293,271
 6,009,729
4,227,019
 4,760,145
Goodwill10,513,371
 10,513,371
10,513,371
 10,513,371
Operating lease right-of-use assets14,222,236
 
Other assets2,724,376
 2,639,354
2,853,089
 2,669,998
Total assets$148,923,066
 $187,239,270
$165,073,296
 $131,113,265
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable and accrued expenses$12,609,959
 $23,278,798
$13,388,013
 $23,134,733
Accounts payable and accrued expenses due to affiliated entities600,701
 926,943
653,568
 977,792
Accrued clinical trial expenses10,359,872
 8,611,892
4,638,397
 5,671,764
Common stock warrants228,665
 360,795
Deferred revenue762,361
 1,175,353
120,694
 223,577
Deferred revenue from affiliated entities55,125
 174,110
96,075
 33,575
Deferred rent979,803
 877,535

 1,065,387
Operating lease liability1,948,716
 
Deferred grant funding2,620,985
 
2,470,657
 4,165,848
Deferred grant funding from affiliated entities188,800
 
763,208
 27,083
Total current liabilities28,406,271
 35,405,426
24,079,328
 35,299,759
Deferred revenue, net of current portion175,157
 215,853
116,630
 150,793
Convertible senior notes62,757,286
 
Deferred rent, net of current portion8,825,052
 9,104,416

 8,518,207
Operating lease liability, net of current portion21,483,568
 
Deferred tax liabilities24,766
 24,766
26,649
 24,766
Deferred grant funding from affiliated entities81,000
 
Other liabilities50,762
 87,333
Total liabilities37,431,246
 44,750,461
108,595,223
 44,080,858
Stockholders’ equity:      
Preferred stock
 

 
Common stock91,474
 90,358
98,584
 97,226
Additional paid-in capital674,017,367
 665,775,504
731,819,389
 707,794,215
Accumulated deficit(562,114,904) (523,356,317)(679,032,924) (620,426,436)
Accumulated other comprehensive loss(598,386) (117,005)
Accumulated other comprehensive income (loss)731,855
 (528,867)
Total Inovio Pharmaceuticals, Inc. stockholders’ equity111,395,551
 142,392,540
53,616,904
 86,936,138
Non-controlling interest96,269
 96,269
2,861,169
 96,269
Total stockholders’ equity111,491,820
 142,488,809
56,478,073
 87,032,407
Total liabilities and stockholders’ equity$148,923,066
 $187,239,270
$165,073,296
 $131,113,265

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
Three Months Ended June 30, Six Months Ended June 30,Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 20172019 2018 2019 2018
Revenues:              
Revenue under collaborative research and development arrangements$24,385,852
 $16,358,316
 $25,674,898
 $20,646,902
$64,283
 $24,385,852
 $2,834,995
 $25,674,898
Revenue under collaborative research and development arrangements with affiliated entities60,319
 176,879
 208,327
 410,209
71,390
 60,319
 126,970
 208,327
Grants and miscellaneous revenue2,590
 2,797,647
 95,180
 8,037,880
Grants and miscellaneous revenue from affiliated entity
 1,079,282
 
 1,693,318
Miscellaneous revenue
 2,590
 3,614
 95,180
Total revenues24,448,761
 20,412,124
 25,978,405
 30,788,309
135,673
 24,448,761
 2,965,579
 25,978,405
Operating expenses:       ��      
Research and development22,462,620
 23,878,751
 47,040,371
 48,421,255
22,486,266
 22,462,620
 46,876,155
 47,040,371
General and administrative7,189,310
 6,169,106
 16,887,325
 13,936,695
5,850,101
 7,189,310
 12,825,129
 16,887,325
Total operating expenses29,651,930
 30,047,857
 63,927,696
 62,357,950
28,336,367
 29,651,930
 59,701,284
 63,927,696
Loss from operations(5,203,169) (9,635,733) (37,949,291) (31,569,641)(28,200,694) (5,203,169) (56,735,705) (37,949,291)
Other income (expense):              
Interest and other income, net396,681
 300,021
 709,204
 640,362
Interest income755,330
 518,525
 1,380,864
 1,083,948
Interest expense(2,194,783) 
 (2,851,031) 
Change in fair value of common stock warrants259,971
 (312,500) 132,130
 (196,023)
 259,971
 
 132,130
Gain (loss) on investment in affiliated entities(2,092,608) 169,096
 287,815
 (1,439,721)(173,212) (2,092,608) (923,315) 287,815
Net loss before provision for income taxes(6,639,125) (9,479,116) (36,820,142) (32,565,023)
Provision for income taxes

 
 (2,169,811) 
Other income (expense), net127,512
 (121,844) 91,673
 (374,744)
Net loss before income tax benefit/(provision for income tax)(29,685,847) (6,639,125) (59,037,514) (36,820,142)
Income tax benefit/(provision for income taxes)106,771
 
 169,571
 (2,169,811)
Net loss$(6,639,125) $(9,479,116) $(38,989,953) $(32,565,023)(29,579,076) (6,639,125) (58,867,943) (38,989,953)
Net loss per share       
Net loss attributable to non-controlling interest191,850
 
 261,455
 
Net loss attributable to Inovio Pharmaceuticals, Inc.$(29,387,226) $(6,639,125) $(58,606,488) $(38,989,953)
Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders       
Basic$(0.07) $(0.13) $(0.43) $(0.44)$(0.30) $(0.07) $(0.60) $(0.43)
Diluted$(0.08) $(0.13) $(0.43) $(0.44)$(0.30) $(0.08) $(0.60) $(0.43)
Weighted average number of common shares outstanding              
Basic91,153,776
 75,409,702
 90,804,722
 74,783,791
98,083,896
 91,153,776
 97,795,910
 90,804,722
Diluted91,241,660
 75,409,702
 90,890,792
 74,783,791
98,083,896
 91,241,660
 97,795,910
 90,890,792

See accompanying notes to unaudited condensed consolidated financial statements.





INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
 
Three Months Ended June 30, Six Months Ended June 30,Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 20172019 2018 2019 2018
Net loss$(6,639,125) $(9,479,116) $(38,989,953) $(32,565,023)$(29,579,076) $(6,639,125) $(58,867,943) $(38,989,953)
Other comprehensive income (loss):              
Unrealized gain (loss) on investment in affiliated entity
 312,253
 
 (437,708)
Unrealized gain (loss) on short-term investments(137,250) 86,862
 (250,015) 290,402
Unrealized gain (loss) on short-term investments, net of tax441,545
 (137,250) 1,260,722
 (250,015)
Comprehensive loss$(6,776,375) $(9,080,001) $(39,239,968) $(32,712,329)$(29,137,531) $(6,776,375) $(57,607,221) $(39,239,968)
Comprehensive loss attributable to non-controlling interest191,850
 
 261,455
 
Comprehensive loss attributable to Inovio Pharmaceuticals, Inc.$(28,945,681) $(6,776,375) $(57,345,766) $(39,239,968)

See accompanying notes to unaudited condensed consolidated financial statements.




INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited)
 Three and Six Months Ended June 30, 2019
 Preferred stock Common stock          
 Number
of shares
 Amount Number
of shares
 Amount Additional
paid-in
capital
 Accumulated
deficit
 Accumulated
other
comprehensive
income (loss)
 Non-
controlling
interest
 Total
stockholders’
equity
Balance at December 31, 201823
 $
 97,225,810
 $97,226
 $707,794,215
 $(620,426,436) $(528,867) $96,269
 $87,032,407
Issuance of common stock for cash
 
 183,200
 183
 907,147
 
 
 
 907,330
Exercise of stock options for cash and vesting of RSUs, net of tax payments
 
 525,000
 525
 (719,922) 
 
 
 (719,397)
Equity component of issuance of convertible notes
 
 
 
 15,752,698
 
 
 
 15,752,698
Stock-based compensation
 
 
 
 3,432,796
 
 
 
 3,432,796
Acquisition of non-controlling interest in Geneos
 
 
 
 
 
 
 3,030,107
 3,030,107
Net loss attributable to common stockholders
 
 
 
 
 (29,219,262) 
 (69,605) (29,288,867)
Unrealized gain on short-term investments, net of tax
 
 
 
 
 
 819,177
 
 819,177
Balance at March 31, 201923
 $
 97,934,010
 $97,934
 $727,166,934
 $(649,645,698) $290,310
 $3,056,771
 $80,966,251
Issuance of common stock for cash
 
 476,600
 476
 1,388,510
 
 
 
 1,388,986
Exercise of stock options for cash and vesting of RSUs, net of tax payments
 
 173,761
 174
 (81,433) 
 
 
 (81,259)
Stock-based compensation
 
 
 
 3,345,378
 
 
 9,817
 3,355,195
Cost of acquisition of non-controlling interest in Geneos
 
 
 
 
 
 
 (13,569) (13,569)
Net loss attributable to common stockholders
 
 
 
 
 (29,387,226) 
 (191,850) (29,579,076)
Unrealized gain on short-term investments, net of tax
 
 
 
 
 
 441,545
 
 441,545
Balance at June 30, 201923
 $
 98,584,371
 $98,584
 $731,819,389
 $(679,032,924) $731,855
 $2,861,169
 $56,478,073


 Three and Six Months Ended June 30, 2018
 Preferred stock Common stock          
 Number
of shares
 Amount Number
of shares
 Amount Additional
paid-in
capital
 Accumulated
deficit
 Accumulated
other
comprehensive
income (loss)
 Non-
controlling
interest
 Total
stockholders’
equity
Balance at December 31, 201723
 $
 90,357,644
 $90,358
 $665,775,504
 $(523,356,317) $(117,005) $96,269
 $142,488,809
Cumulative effect of accounting change
 
 
 
 
 231,366
 (231,366) 
 
Exercise of stock options for cash and vesting of RSUs, net of tax payments
 
 347,287
 347
 (506,750) 
 
 
 (506,403)
Stock-based compensation
 
 
 
 3,575,750
 
 
 
 3,575,750
Net loss attributable to common stockholders
 
 
 
 
 (32,350,828) 
 
 (32,350,828)
Unrealized loss on short-term investments
 
 
 
 
 
 (112,765) 
 (112,765)
Balance at March 31, 201823
 $
 90,704,931
 $90,705
 $668,844,504
 $(555,475,779) $(461,136) $96,269
 $113,094,563
Issuance of common stock for cash
 
 407,429
 407
 1,972,994
 
 
 
 1,973,401
Exercise of stock options for cash and vesting of RSUs, net of tax payments
 
 362,035
 362
 610,699
 
 
 
 611,061
Stock-based compensation
 
 
 
 2,589,170
 
 
 
 2,589,170
Net loss attributable to common stockholders
 
 
 
 
 (6,639,125) 
 
 (6,639,125)
Unrealized loss on short-term investments
 
 
 
 
 
 (137,250) 
 (137,250)
Balance at June 30, 201823
 $
 91,474,395
 $91,474
 $674,017,367
 $(562,114,904) $(598,386) $96,269
 $111,491,820

See accompanying notes to unaudited condensed consolidated financial statements.


INOVIO PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended June 30,Six Months Ended June 30,
2018 20172019 2018
Cash flows from operating activities:      
Net loss$(38,989,953) $(32,565,023)$(58,867,943) $(38,989,953)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation1,841,084
 1,020,679
1,863,225
 1,841,084
Amortization of intangible assets716,458
 810,539
533,126
 716,458
Change in value of common stock warrants(132,130) 196,023

 (132,130)
Stock-based compensation6,164,958
 7,937,473
6,787,991
 6,164,958
Amortization of operating lease right-of-use assets2,851,031
 
Amortization of premiums on investments71,559
 140,599
1,962
 71,559
Loss on short-term investments373,822
 67,366
Deferred rent(177,096) 1,869,341
Loss (gain) on short-term investments(93,273) 373,822
Loss (gain) on equity investment in affiliated entities(287,815) 1,439,721
923,315
 (287,815)
Non-cash lease expense412,533
 
Tax benefit from other unrealized gains on short-term investments(335,228) 
Changes in operating assets and liabilities:      
Accounts receivable4,290,243
 8,298,963
3,186,131
 4,290,243
Accounts receivable from affiliated entities(473,834) (440,945)(258,353) (473,834)
Prepaid expenses and other current assets815,825
 (3,165,705)(902,772) 815,825
Prepaid expenses and other current assets from affiliated entities58,710
 260,694
20,059
 58,710
Other assets(85,022) 438,896
(183,091) (85,022)
Accounts payable and accrued expenses(9,443,933) (4,305,114)(9,187,074) (9,443,933)
Accrued clinical trial expenses1,747,980
 820,362
(1,033,367) 1,747,980
Accounts payable and accrued expenses due to affiliated entities(326,242) (225,158)(324,224) (326,242)
Deferred revenue(453,688) (14,325,900)(137,046) (453,688)
Deferred revenue from affiliated entities(118,985) (219,792)62,500
 (118,985)
Operating lease right-of-use assets and liabilities, net(786,079) (177,096)
Deferred grant funding2,620,985
 
(1,695,191) 2,620,985
Deferred grant funding from affiliated entities188,800
 
817,125
 188,800
Other liabilities(34,688) 
Net cash used in operating activities(31,598,274) (31,946,981)(56,379,331) (31,598,274)
Cash flows from investing activities:      
Purchases of investments(31,318,982) (14,600,112)(73,698,391) (31,318,982)
Maturities of investments53,753,066
 32,173,342
46,688,689
 53,753,066
Purchases of capital assets(1,614,767) (5,828,137)(739,808) (1,614,767)
Net cash provided by investing activities20,819,317
 11,745,093
Net cash (used in) provided by investing activities(27,749,510) 20,819,317
Cash flows from financing activities:      
Proceeds from issuance of convertible senior notes75,658,953
 
Proceeds from issuance of common stock, net of issuance costs1,973,401
 24,060,196
2,296,316
 1,973,401
Proceeds from stock option and warrant exercises, net of tax payments104,620
 865,857
Taxes paid related to net share settlement of equity awards, net of proceeds from stock option exercises(800,656) 104,620
Acquisition of non-controlling interest3,016,538
 
Net cash provided by financing activities2,078,021
 24,926,053
80,171,151
 2,078,021
(Decrease) Increase in cash and cash equivalents(8,700,936) 4,724,165
Decrease in cash and cash equivalents(3,957,690) (8,700,936)
Cash and cash equivalents, beginning of period23,786,579
 19,136,472
23,693,633
 23,786,579
Cash and cash equivalents, end of period$15,085,643
 $23,860,637
$19,735,943
 $15,085,643
      
Supplemental disclosure of non-cash activities      
Change in amounts accrued for purchases of property and equipment$1,224,906
 $1,185,087
Amounts accrued for purchases of property and equipment$
 $29,211
See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Operations
Inovio Pharmaceuticals, Inc. (the “Company” or “Inovio”), is a clinical stage biopharmaceuticalbiotechnology company develops active SynCon® DNA immunotherapies and vaccines focused on preventingthe discovery, development, and treatingcommercialization of its synthetic DNA technology targeted against cancers and infectious diseases. Inovio’sThe Company's DNA-based immunotherapies and vaccines, in combination with its proprietary, CELLECTRA®efficacy-enabling delivery devices, are intended to generate optimal antigen production in vivo, robust immune responses, in particular functional CD8+ killer T cellcells and antibody responses,antibodies, to fight target diseases.
Inovio’s synthetic products are based on its SynCon® immunotherapy design. The Company and its collaborators are currently conducting or planning clinical programs of its proprietary SynCon®SynCon® immunotherapies for HPV-caused pre-cancers, including cervical, vulvar and cancers;anal dysplasia; HPV-caused cancers, including head & neck, cervical, anal, penile, vulvar, and vaginal; other HPV-caused disorders, such as recurrent respiratory papillomatosis (RRP); glioblastoma multiforme ("GBM"); prostate breast, lung and pancreatic cancers;cancer; hepatitis B virus ("HBV");virus; hepatitis C virus; HIV; Ebola; Lassa fever; Middle East Respiratory Syndrome, ("MERS");or MERS; Lassa fever; and Zika virus. The Company also recently announced its intention to accelerate the clinical development of its dBTE (DNA-encoded bi-specific T cell engagers) technology and build on recent advances of its dMAb™ (DNA-encoded monoclonal antibody) technology.
The Company's partners and collaborators include MedImmune, LLC, The Wistar Institute, University of Pennsylvania,AstraZeneca PLC, Regeneron Pharmaceuticals, Inc., F. Hoffmann-La Roche AG/Genentech, Inc., ApolloBio Corporation, GeneOne Life Science Inc. ("GeneOne"), ApolloBio Corporation, Regeneron Pharmaceuticals, Inc.The Bill and Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (“CEPI”), Genentech, Inc.Parker Institute for Cancer Immunotherapy ("PICI"), Plumbline Life Sciences, Inc.Defense Advanced Research Projects Agency (“DARPA”), Drexel University,National Institutes of Health ("NIH"), National Institute of Allergy and Infectious Diseases (“NIAID”), United States Military HIV Research Program, U.S. Army Medical ResearchNational Cancer Institute of Infectious Diseases, National Institutes of Health,("NCI"), HIV Vaccines Trial Network Defense Advanced Research Projects Agency (“DARPA”("HVTN"), ParkerWalter Reed Army Institute for Cancer Immunotherapy,of Research, Medical CBRN Defense Consortium ("MCDC"), The Wistar Institute, and Coalition for Epidemic Preparedness Innovations (“CEPI”).the University of Pennsylvania.
Inovio was incorporated in Delaware in June 2001 and has its principal executive offices in Plymouth Meeting, Pennsylvania.

2. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of Inovio have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) as contained in the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") for interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of June 30, 2018,2019, the condensed consolidated statements of operations, andthe condensed consolidated statements of comprehensive loss and the condensed consolidated statements of stockholders' equity for the three and six months ended June 30, 20182019 and 20172018 and the condensed consolidated statements of cash flows for the six months ended June 30, 20182019 and 20172018 are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, results of operations, and cash flows and changes in stockholders' equity for the periods presented. The results of operations for the three and six months ended June 30, 20182019 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2018,2019, or for any other period. These unaudited financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2017,2018, included in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 14, 2018.12, 2019. The balance sheet at December 31, 20172018 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The Company has evaluated subsequent events after the balance sheet date of June 30, 2018 through the date it filed these unaudited condensed consolidated financial statements with the SEC.
These unaudited condensed consolidated financial statements include the accounts of Inovio Pharmaceuticals, Inc. and its subsidiaries. The Company consolidates its wholly-owned subsidiaries Genetronics, Inc., and VGX and GENEOS Therapeutics,Pharmaceuticals, Inc., ("VGX") and records a non-controlling interest for the39% of its subsidiary Geneos Therapeutics, Inc. ("Geneos") as well as 15% of VGX Animal Health, Inc., a subsidiary of VGX, that it did not own as of June 30, 2018 and December 31, 2017.VGX. All intercompany accounts and transactions have been eliminated upon consolidation.
Inovio incurred a net loss attributable to common stockholders of $29.4 million and $58.6 million for the three and six months ended June 30, 2019, respectively. Inovio had working capital of $86.4 million and an accumulated deficit of $679.0 million as of June 30, 2019. The preparationCompany has incurred losses in each year since its inception and expects to continue to incur significant expenses and operating losses for the foreseeable future in connection with the research and preclinical and clinical development of its product candidates. The Company’s cash, cash equivalents and short-term investments of $106.0 million

and long-term investments of $8.5 million as of June 30, 2019, are sufficient to support the Company's operations for a period of at least 12 months from the date it is issuing these financial statements. In addition, the Company could sell up to an additional $69.7 million in shares of its common stock under its At-the-Market Equity Offering Sales Agreement (the “Sales Agreement”), subject to certain conditions set forth in the Sales Agreement.
In order to continue to fund future research and development activities, the Company will need to seek additional capital. This may occur through strategic alliance and licensing arrangements and/or future public or private debt or equity financings including use of its Sales Agreement. Although the Company has a history of debt and equity financings, including the receipt of net proceeds of $75.7 million from a private placement of $78.5 million aggregate principal amount of its 6.50% convertible senior notes due 2024 (the “Notes”) in the first quarter of 2019, net proceeds of $1.4 million and $2.3 million under the Sales Agreement during the three and six months ended June 30, 2019, respectively, and net proceeds of $29.2 million under the Sales Agreement and a prior at-the-market equity offering agreement during the year ended December 31, 2018, sufficient funding may not be available, or if available, may be on terms that significantly dilute or otherwise adversely affect the rights of existing stockholders. If adequate funds are not available in the future, the Company may need to delay, reduce the scope of or put on hold one or more of its clinical and/or preclinical programs.
The Company’s ability to continue its operations is dependent upon its ability to obtain additional capital in the future and achieve profitable operations. The Company expects to continue to rely on outside sources of financing to meet its capital needs and the Company may never achieve positive cash flow. These condensed consolidated financial statements in conformity with U.S. GAAP requires managementdo not include any adjustments to make estimatesthe specific amounts and assumptions that affect the reported amountsclassifications of assets, liabilities, disclosures of contingent assets and liabilities, atwhich might be necessary should Inovio be unable to continue as a going concern. Inovio’s condensed consolidated financial statements as of and for the three and six months ended June 30, 2019 have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business for the foreseeable future. The Company has evaluated subsequent events after the balance sheet date through the date of theit issued these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.statements.

3. Critical Accounting Policies
Revenue Recognition

Effective January 1, 2018, the Company adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“Topic 606”) using the modified retrospective method which consisted of applying and recognizing the cumulative effect of Topic 606 at the date of initial application. Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”), including most industry-specific revenue recognition guidance throughout the Industry Topics of the ASC. All periods prior to the adoption date of Topic 606 have not been restated to reflect the impact of the adoption of Topic 606, but continue to be accounted for and presented under Topic 605.
The following paragraphs in this section describe the Company's revenue recognition accounting policies under Topic 606 upon adoption on January 1, 2018. Refer to Note 2 to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017 for revenue recognition accounting policies under Topic 605.
The Company will recognizerecognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company will assessassesses the goods or services agreed upon within each contract and assess whether each good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Collaborative Arrangements
The Company enters into collaborative arrangements with partners that typically include payment of one or more of the following: (i) license fees; (ii) product supply services; (iii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iii)(iv) royalties on net sales of licensed products. Where a portion of non-refundable, up-frontupfront fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied.
As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgment of management to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The stand-alonestandalone selling price may include items such as forecasted revenues, development timelines, discount rates and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

License Fees
If a license to intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenues from non-refundable, up-frontupfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company will utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Product Supply Services
Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company will assess if these options provide a material right to the licensee and if so, they will be accounted for as separate performance obligations.
Milestone Payments
At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's or its collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment.

Royalties
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements.
Under certain collaborative arrangements, the Company has been reimbursed for a portion of its research and development ("R&D") expenses, including costs of drug supplies. When these R&D services are performed under a reimbursement or cost sharing model with its collaboration partner, the Company records these reimbursements as a reduction of R&D expense in its condensed consolidated statements of operations.
Grants
The Company has determined that as of January 1, 2018, accounting for the Company’s various grant agreements falls under the contributions guidance under Subtopic 958-605,, Not-for-Profit Entities-Revenue Recognition, which is outside the scope of Topic 606, as the government agencies granting the Company funds are not receiving reciprocal value for their contributions. Beginning on January 1, 2018, all contributions received from current grant agreements are recorded as a contra-expense as opposed to revenue on the condensed consolidated statement of operations.
Leases
The Company adopted ASU 2016‑02, Leases (Topic 842) (“Topic 842”) on January 1, 2019. For its long-term operating leases, the Company recognized an operating lease right-of-use asset and an operating lease liability on its condensed consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The Company determines the lease term at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise.
Fixed rent expense for the Company's operating leases is recognized on a straight-line basis over the term of the lease and is included in operating expenses on the condensed consolidated statements of operations. Variable lease payments including lease operating expenses are recorded as incurred.
Prior period amounts continue to be reported in accordance with the historic accounting under the previous lease guidance, ASC 840, Leases (Topic 840). See “Impact of Recently Issued Accounting Standards” below, for more information about the impact of the adoption of Topic 842.
Valuation of Intangible Assets and Goodwill
Intangible assets are amortized over their estimated useful lives ranging from 2two to 18 years. Acquired intangible assets are continuously being developed for the future economic viability contemplated at the time of acquisition. The Company is

concurrently conducting preclinical studies and clinical trials using the acquired intangibles and has entered into licensing agreements for the use of these acquired intangibles.
Historically, the Company has recorded patents at cost and amortized these costs using the straight-line method over the expected useful lives of the patents or 17 years, whichever is less. Patent cost consists of the consideration paid for patents and related legal costs. Effective as of the acquisition of VGX Pharmaceuticals, Inc. ("VGX") in 2009, all new patent costs are expensed as incurred, with patent costs capitalized as of that date continuing to be amortized over the expected life of the patent. License costs are recorded based on the fair value of consideration paid and are amortized using the straight-line method over the shorter of the expected useful life of the underlying patents or the term of the related license agreement to the extent the license has an alternative future use. As of June 30, 20182019 and December 31, 2017,2018, the Company’s intangible assets resulting from the acquisition of VGX, as well as the acquisitions of two other companies, Inovio AS and Bioject Medical Technologies, Inc. ("Bioject"), and additional intangibles including previously capitalized patent costs and license costs, net of accumulated amortization, totaled $5.3$4.2 million and $6.0$4.8 million, respectively.
The determination of the value of intangible assets requires management to make estimates and assumptions that affect the Company’s condensed consolidated financial statements. The Company assesses potential impairments to intangible assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. The Company’s judgments regarding the existence of impairment indicators and future cash flows related to intangible assets are based on operational performance of its acquired businesses, market conditions and other factors. If impairment is indicated, the Company will reduce the carrying value of the intangible asset to fair value. While current and historical operating and cash flow losses are potential indicators of impairment, the Company believes the future cash flows to be received from its intangible assets will exceed the intangible assets’ carrying value, and accordingly, the Company has not recognized any impairment losses through June 30, 2018.2019.
Goodwill represents the excess of acquisition cost over the fair value of the net assets of acquired businesses. Goodwill is reviewed for impairment at least annually at November 30, or more frequently if an event occurs indicating the potential for impairment. During its goodwill impairment review, the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If, after assessing the totality of these qualitative factors, the Company determines that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, the Company proceeds to perform the two-step test for goodwill impairment. The first step involves comparing the estimated fair value of the reporting unit with its carrying value, including goodwill. If the carrying amount of the reporting unit exceeds its fair value, the Company performs the second step of the goodwill impairment test to determine the amount of loss, which involves comparing the implied fair value of the goodwill to the carrying value of the goodwill. The Company may also elect to bypass the qualitative assessment in a period and elect to proceed to perform the first step of the goodwill impairment test. The Company performed its annual assessment for goodwill impairment as of November 30, 2017,2018, identifying no impairment.

Although there are inherent uncertainties in this assessment process, the estimates and assumptions the Company is using are consistent with its internal planning. If these estimates or their related assumptions change in the future, the Company may be required to record an impairment charge on all or a portion of its goodwill and intangible assets. Furthermore, the Company cannot predict the occurrence of future impairment triggering events nor the impact such events might have on its reported asset values. Future events could cause the Company to conclude that impairment indicators exist and that goodwill or other intangible assets associated with its acquired businesses are impaired. Any resulting impairment loss could have an adverse impact on the Company’s results of operations. See Note 8 for further discussion of the Company’s goodwill and intangible assets.
Research and Development Expenses
The Company’s activities have largely consisted of research and development efforts related to developing electroporation delivery technologies and DNA immunotherapies and vaccines. Research and development expenses consist of expenses incurred in performing research and development activities including salaries and benefits, facilities and other overhead expenses, clinical trials, contract services and other outside expenses. Research and development expenses are charged to operations as they are incurred. These expenses result from the Company's independent research and development efforts as well as efforts associated with collaborations and licensing arrangements. The Company reviews and accrues clinical trial expense based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies and other events. The Company follows this method since reasonably dependable estimates of the costs applicable to various stages of a research agreement or clinical trial can be made. Accrued clinical trial costs are subject to revisions as trials progress. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a

modification in the protocol of a clinical trial or cancellation of a trial could result in a charge to the Company's results of operations.

4. Impact of Recently Issued Accounting Standards
The recent accounting pronouncements below may have a significant effect on the Company's financial statements. Recent accounting pronouncements that are not anticipated to have an impact on or are unrelated to the Company's financial condition, results of operations, or related disclosures are not discussed.
ASU No. 2014-09. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers ("Topic 606”), which amended the existing accounting standards for revenue recognition, outlines a comprehensive revenue recognition model and supersedes most current revenue recognition guidance. The new standard requires a company to recognize revenue upon transfer of goods or services to a customer at an amount that reflects the expected consideration to be received in exchange for those goods or services. The amended guidance defines a five-step approach for recognizing revenue, which will require a company to use more judgment and make more estimates than under the current guidance. The Company adopted this new standard effective January 1, 2018, using the modified retrospective transition method. The impact of adoption of Topic 606 on the Company's existing agreements was as follows:
Collaboration Agreement with MedImmune
The Company has determined that no cumulative catch-up adjustment was required.
Grant Agreements
The Company has determined that as of January 1, 2018, accounting for the Company’s various grant agreements falls under the contributions guidance under Subtopic 958-605, Not-for-Profit Entities-Revenue Recognition, which is outside the scope of Topic 606, as the government agencies granting the Company funds are not receiving reciprocal value for their contributions. Beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three and six months ended June 30, 2018, $1.9 million and $4.1 million, respectively, would have been recorded as grant revenue but under the new guidance was instead recorded as a reduction to research and development expense.
The following table illustrates the impact that adopting Topic 606 has had on the Company's reported results in the condensed consolidated statement of operations for the three months ended June 30, 2018.

 Balances Without Adoption of Topic 606 for the Three Months Ended June 30, 2018 Impact of Adopting Topic 606 As Reported for the Three Months Ended June 30, 2018
Revenues:     
Revenue under collaborative research and development arrangements$24,385,852

$
 $24,385,852
Revenue under collaborative research and development arrangements with affiliated entities60,319


 60,319
Grants and miscellaneous revenue1,459,684

(1,457,094) 2,590
Grants and miscellaneous revenue from affiliated entity454,820

(454,820) 
Total revenues26,360,675
 (1,911,914) 24,448,761
Operating expenses:     
Research and development24,374,534
 (1,911,914) 22,462,620
General and administrative7,189,310
 
 7,189,310
Total operating expenses$31,563,844
 $(1,911,914) $29,651,930
The following table illustrates the impact that adopting Topic 606 has had on the Company's reported results in the condensed consolidated statement of operations for the six months ended June 30, 2018.
 Balances Without Adoption of Topic 606 for the Six Months Ended June 30, 2018 Impact of Adopting Topic 606 As Reported for the Six Months Ended June 30, 2018
Revenues:     
Revenue under collaborative research and development arrangements$25,674,898
 $
 $25,674,898
Revenue under collaborative research and development arrangements with affiliated entities208,327
 
 208,327
Grants and miscellaneous revenue2,016,674
 (1,921,494) 95,180
Grants and miscellaneous revenue from affiliated entity2,212,571
 (2,212,571) 
Total revenues30,112,470
 (4,134,065) 25,978,405
Operating expenses:     
Research and development51,174,436
 (4,134,065) 47,040,371
General and administrative16,887,325
 
 16,887,325
Total operating expenses$68,061,761
 $(4,134,065) $63,927,696

ASU No. 2016-01. In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities2016-02. The amended guidance requires the Company to measure and record equity investments, except those accounted for under the equity method of accounting that have a readily determinable fair value, at fair value and for the Company to recognize the changes in fair value in its consolidated statements of operations, instead of recognizing unrealized gains and losses through accumulated other comprehensive income (loss), as done under the previous guidance. The amended guidance also changes several disclosure requirements for financial instruments, including the methods and significant assumptions used to estimate fair value. The standard was effective for annual reporting periods beginning after December 15, 2017, including interim periods within those annual reporting periods. The Company adopted this guidance on January 1, 2018 and recorded a $231,366 cumulative effect adjustment to reclassify the cumulative unrealized gain, net of tax effect, from its investment in Plumbline Life Sciences, Inc. ("PLS") from accumulated other comprehensive loss to accumulated deficit. After the adoption of ASU No. 2016-01, the Company recorded a (loss) gain on investment in affiliated entity related to PLS of $(639,000) and $343,000 on the condensed consolidated statement of operations for the three and six months ended June 30, 2018, respectively.
The cumulative effect of the changes made to the Company's condensed consolidated balance sheet as of January 1, 2018 for the adoption of ASU No. 2016-01 are included in the table below:

Equity:Balance at December 31, 2017 Adjustments due to ASU No. 2016-01 Balance at January 1, 2018
Accumulated deficit$(523,356,317) $231,366
 $(523,124,951)
Accumulated other comprehensive loss$(117,005) $(231,366) $(348,371)

ASU No. 2016-02. In February 2016, the FASB issued ASU No. 2016-02, Leases. UnderTopic 842, which requires lessees to recognize most leases on the balance sheet as lease liabilities with corresponding right-of-use assets and to disclose key information about leasing arrangements. The Company adopted the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (a) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measuredstandard on a discounted basis; and (b) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. The ASU will be effective for the Company beginning January 1, 2019 using the modified retrospective approach. The Company elected the available package of practical expedients upon adoption, which allowed the Company to carry forward its historical assessment of whether existing agreements contained a lease and the classification of its existing operating leases. Upon adoption, the Company recognized an operating right-of use asset and operating lease liability in its condensed consolidated balance sheet of approximately $14.6 million and $24.2 million, respectively. The Company also classified deferred rent of $9.6 million as an offset to the Company’s operating right-of-use asset upon adoption. There were no adjustments to the Company’s opening accumulated deficit balance upon adoption.
The impact of the adoption of Topic 842 on the condensed consolidated balance sheets as of January 1, 2019 was as follows:
 ASC 840   Topic 842
 January 1, 2019 Impact of Adoption January 1, 2019
Deferred rent$1,065,387
 $(1,065,387) $
Deferred rent, net of current portion$8,518,207
 $(8,518,207) $
Operating right-of-use assets$
 $14,634,769
 $14,634,769
Operating lease liability$
 $1,733,600
 $1,733,600
Operating lease liability, net of current portion$
 $22,484,763
 $22,484,763

ASU No. 2018-07. In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, that simplifies the accounting for stock-based payments granted to non-employees for services by generally aligning it with earlythe accounting for stock-based payments granted to employees. The Company adopted the standard on January 1, 2019 and there was no material impact to its condensed consolidated financial statements.
ASU No. 2018-13. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which amends certain disclosure requirements over Level 1, Level 2 and Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact of the application of this accounting standard updateadopting ASU 2018-13, but does not anticipate it will have a material impact on its financial statementsdisclosures.
ASU No. 2018-18. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and related disclosures.Topic 606, which clarified the interaction between Topic 808, Collaborative Arrangements, and Topic 606, Revenue from Contracts with Customers. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company is currently has three operating leases for its office and laboratory spaces in San Diego, California and Plymouth Meeting, Pennsylvania that it expects to be impacted byevaluating the new accounting standard that will result in the present valuesimpact of the future lease payments being presented as right-to-use assets, with a corresponding lease liability at the date of adoption.adopting ASU 2018-18.

5. Revenue Recognition
On January 1, 2018, the Company adopted Topic 606 using the modified retrospective method. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting under Topic 605.
For additional details about Topic 606, refer to Note 3 above.
The following table summarizes changes in the Company’s contract assets and liabilities for the six months ended June 30, 2018:
 Balance at January 1, 2018 Additions Deductions Balance at June 30, 2018
Contract assets       
Accounts receivable from MedImmune$1,693,530
 $2,541,901
 $(3,142,901) $1,092,530
Contract liabilities       
Deferred revenue - MedImmune1,145,500
 582,500
 (882,000) 846,000
Deferred revenue - ApolloBio
 23,000,000
 (23,000,000) 
Deferred revenue - Other$271,894
 $
 $(125,251) $146,643

During the three and six months ended June 30, 2018,2019, the Company recognized total revenue under collaborative research and development and other agreements of $23.0 million from ApolloBio; $1.4 million$62,000 and $2.7$2.8 million, respectively, from MedImmune; $32,000AstraZeneca and $150,000, respectively, from its affiliated entity GeneOne Life Science Inc. ("GeneOne");$74,000 and $31,000 and $153,000,$191,000, respectively, from various other contracts. The Company defers revenue when a contract is entered into with a collaborator and cash payments are received prior to satisfaction of the related performance obligation. Of the total revenue recognized during the three and six months ended June 30, 2019, $36,000 and $215,000, respectively, was in deferred revenue as of December 31, 2018. Of the total revenue recognized during the three and six months ended June 30, 2018, $354,000 and $1.0 million, respectively, was in deferred revenue as of December 31, 2017. All revenues recognized duringPerformance obligations are generally satisfied within 12 months of the three and six months ended June 30, 2018 are attributed to the United States.initial contract date.


6. Investments
Investments at June 30, 2018 and2019 consisted of mutual funds. Investments at December 31, 20172018 consisted of mutual funds and United States corporate debt securities and an equity investment in the Company's affiliated entity PLS.securities. Investments are recorded at fair value, based on current market valuations. After the adoption of ASU No. 2016-01 on January 1, 2018, unrealized gains and losses on the Company's equity securities are reported in the condensed consolidated statement of operations as non-operating other income (expense). Unrealized gains and losses on the Company's debt securities will continue to be excluded from earnings and are reported as a separate component of other comprehensive loss until realized. Realized gains and losses are included in non-operating other income (expense) on the condensed consolidated statement of operations and are derived using the specific identification method for determining the cost of the securities sold. During the three and six months ended June 30, 2018, $121,0002019, $129,000 and $374,000,$93,000, respectively, of net realized lossgain on investments was recorded. During the three and six months ended June 30, 2017, $16,0002018, $(121,000) and $67,000,$(374,000), respectively, of net realized loss on investments was recorded. The Company assessed each of its investments on an individual basis to determine if any decline in fair value was other-than-temporary. Interest and dividends on investments classified as available-for-sale are included in interest and other income, net, in the condensed consolidated statements of operations. As of June 30, 2018,2019, the Company had 28no available-for-sale securities in a grossan unrealized loss position, of which 8 with an aggregate total unrealized loss of $91,000 were in such position for longer than 12 months.

The following is a summary of available-for-sale securities as of June 30, 20182019 and December 31, 2017:2018:

   As of June 30, 2018
 
Contractual
Maturity (in years)
Cost 
Gross Unrealized
Gains
 
Gross Unrealized
Losses
 Fair Market Value
Mutual funds--- $69,855,486
 $
 $(532,970) $69,322,516
US corporate debt securitiesLess than 2 11,252,264
 
 (65,416) 11,186,848
Investment in affiliated entity (PLS)--- 
 2,667,805
 
 2,667,805
Total investments  $81,107,750
 $2,667,805
 $(598,386) $83,177,169
   As of June 30, 2019
 
Contractual
Maturity (in years)
Cost 
Gross Unrealized
Gains
 
Gross Unrealized
Losses
 Fair Market Value
Mutual funds--- $85,168,756
 $1,067,059
 $
 $86,235,815
  As of December 31, 2017  As of December 31, 2018
Contractual
Maturity (in years)
Cost 
Gross Unrealized
Gains
 
Gross Unrealized
Losses
 Fair Market Value
Contractual
Maturity (in years)
Cost 
Gross Unrealized
Gains
 
Gross Unrealized
Losses
 Fair Market Value
Mutual funds--- $68,776,165
 $42,097
 $(252,373) $68,565,889
--- $57,842,955
 $
 $(528,084) $57,314,871
US corporate debt securitiesLess than 2 35,210,121
 3,032
 (140,198) 35,072,955
Less than 2 224,633
 
 (652) 223,981
Investment in affiliated entity (PLS)--- 
 2,325,079
 
 2,325,079
Total investments $103,986,286
 $2,370,208
 $(392,571) $105,963,923
 $58,067,588
 $
 $(528,736) $57,538,852

7. Marketable Securities and Fair Value Measurements
The guidance regarding fair value measurements establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets that are accessible at the measurement date; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. The Company did not have any transfer of assets and liabilities between Level 1, Level 2 and Level 3 of the fair value hierarchy during the six months ended June 30, 20182019 or 2017.2018.
The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis, and are determined using the following inputs as of June 30, 2018:2019:
 
 Fair Value Measurements at
 June 30, 2018
 Total 
Quoted Prices
in Active Markets
(Level 1)
 
Significant
Other Unobservable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Assets:       
Money market funds$1,649,759
 $1,649,759
 $
 $
Mutual funds69,322,516
 
 69,322,516
 
US corporate debt securities11,186,848
 
 11,186,848
 
Investment in affiliated entities11,682,295
 11,682,295
 
 
Total Assets$93,841,418
 $13,332,054
 $80,509,364
 $
Liabilities:       
Common stock warrants$228,665
 $
 $
 228,665
Total Liabilities$228,665
 $
 $
 $228,665
 Fair Value Measurements at
 June 30, 2019
 Total 
Quoted Prices
in Active Markets
(Level 1)
 
Significant
Other Unobservable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Assets:       
Money market funds$4,595,008
 $4,595,008
 $
 $
Mutual funds86,235,815
 
 86,235,815
 
Investment in affiliated entities8,482,598
 8,482,598
 
 
Total assets$99,313,421
 $13,077,606
 $86,235,815
 $

The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis, and are determined using the following inputs as of December 31, 2017:2018:

Fair Value Measurements atFair Value Measurements at
December 31, 2017December 31, 2018
Total 
Quoted Prices
in Active Markets
(Level 1)
 
Significant
Other Unobservable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Total 
Quoted Prices
in Active Markets
(Level 1)
 
Significant
Other Unobservable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Assets:              
Money market funds$9,843,482
 $9,843,482
 $
 $
$9,646,507
 $9,646,507
 $
 $
Mutual funds68,565,889
 
 68,565,889
 
57,314,871
 
 57,314,871
 
US corporate debt securities35,072,955
 
 35,072,955
 
223,981
 
 223,981
 
Investment in affiliated entities11,394,480
 11,394,480
 
 
9,405,913
 9,405,913
 
 
Total Assets$124,876,806
 $21,237,962
 $103,638,844
 $
Liabilities:       
Common stock warrants$360,795
 $
 $
 $360,795
Total Liabilities$360,795
 $
 $
 $360,795
Total assets$76,591,272
 $19,052,420
 $57,538,852
 $

Level 1 assets at June 30, 20182019 consisted of money market funds held by the Company that are valued at quoted market prices, as well as the Company’s investments in affiliates, GeneOne and PLS. The Company accounts for its investment in 1,644,155 common shares of GeneOne based on the closing price of the shares on the Korean Stock Exchange on the applicable balance sheet date. The Company accounts for its investment in 395,758 common shares of PLS as an equity investment with a fair value based on the closing price of the shares on the Korea New Exchange (KONEX) Market on the applicable balance sheet date. The Company elected the fair value option in conjunction with the investment in GeneOne at the inception of the investment; therefore, changes in the fair value of the investment are reflected as other income (expense) in the condensed consolidated statements of operations. The Company did not elect the fair value option for the investment in PLS at the inception of the investment, but rather recorded the investment under the equity method until its ownership interest dropped below 20% in June 2015 and, accordingly, began recording the investment under the cost method using the carryover basis from the equity method of zero. Once shares of PLS began trading on the KONEX, the Company classified the investment as available-for-sale and began recording the investment at fair value. After the adoption of ASU No. 2016-01 on January 1, 2018, unrealizedUnrealized gains and losses on the Company's equity securities are reported in the condensed consolidated statement of operations as a gain (loss) on investment in affiliated entities, as discussed in Note 4.entities.
Level 2 assets at June 30, 20182019 consisted of U.S. corporate debt securities and mutual funds held by the Company that are initially valued at the transaction price and subsequently valued, at the end of each reporting period, typically utilizing market observable data. The Company obtains the fair value of its Level 2 assets from a professional pricing service, which may use quoted market prices for identical or comparable instruments, or inputs other than quoted prices that are observable either directly or indirectly. The professional pricing service gathers quoted market prices and observable inputs from a variety of industry data providers. The valuation techniques used to measure the fair value of the Company's Level 2 financial instruments were derived from non-binding market consensus prices that are corroborated by observable market data, quoted market prices for similar instruments, or pricing models such as discounted cash flow techniques. The Company validates the quoted market prices provided by the primary pricing service by comparing the service's assessment of the fair values of the Company's investment portfolio balance against the fair values of the Company's investment portfolio balance obtained from an independent source.
There were no Level 3 assets held as of June 30, 2018.

Level 3 liabilities at June 30, 2018 consisted of common stock warrant liabilities associated with warrants to purchase the Company's common stock issued in March 2013. If unexercised, the warrants will expire in September 2018. During the six months ended June 30, 2018 and 2017, none of these warrants were exercised.
As of June 30, 2018, the Company had a $229,000 common stock warrant liability. The Company reassesses the fair value of the common stock warrants at each reporting date utilizing a Black-Scholes pricing model. Inputs used in the pricing model include estimates of stock price volatility, expected warrant life and risk-free interest rate. The Company develops its estimates based on historical data. The assumptions used to estimate the fair value of common stock warrants at June 30, 2018 are presented below:

Risk-free interest rate2.32%
Expected volatility43%
Expected life in years0.2
Dividend yield
Changes in these assumptions as well as fluctuations in the Company's stock price on the valuation date can have a significant impact on the fair value of the common stock warrant liability. As a result of these calculations, the Company recorded a decrease in fair value of $260,000 and $132,000 for the three and six months ended June 30, 2018, respectively, and an increase in fair value of $313,000 and $196,000 for the three and six months ended June 30, 2017, respectively. The change in fair value of common stock warrants is reflected in the Company's condensed consolidated statements of operations.
The following table presents the changes in fair value of the Company’s Level 3 financial liabilities for the six months ended June 30, 2018:
Balance at December 31, 2017$360,795
Decrease attributable to change in fair value of common stock warrants(132,130)
Balance at June 30, 2018$228,665

2019.

8. Goodwill and Intangible Assets
The following sets forth the goodwill and intangible assets by major asset class:
 

  June 30, 2018 December 31, 2017  June 30, 2019 December 31, 2018
Useful
Life
(Yrs)
Gross 
Accumulated
Amortization
 
Net Book
Value
 Gross 
Accumulated
Amortization
 
Net Book
Value
Useful
Life
(Yrs)
Gross 
Accumulated
Amortization
 
Net Book
Value
 Gross 
Accumulated
Amortization
 
Net Book
Value
Indefinite lived:                        
Goodwill(a) $10,513,371
 $
 $10,513,371
 $10,513,371
 $
 $10,513,371
 $10,513,371
 $
 $10,513,371
 $10,513,371
 $
 $10,513,371
Definite lived:                        
Patents8 – 17 5,802,528
 (5,711,876) 90,652
 5,802,528
 (5,681,673) 120,855
8 – 17 5,802,528
 (5,772,282) 30,246
 5,802,528
 (5,742,079) 60,449
Licenses8 – 17 1,323,761
 (1,204,983) 118,778
 1,323,761
 (1,190,609) 133,152
8 – 17 1,323,761
 (1,233,731) 90,030
 1,323,761
 (1,219,357) 104,404
CELLECTRA®(b)
5 – 11 8,106,270
 (7,465,649) 640,621
 8,106,270
 (7,252,108) 854,162
5 – 11 8,106,270
 (7,892,730) 213,540
 8,106,270
 (7,679,190) 427,080
GHRH(b)11 335,314
 (287,788) 47,526
 335,314
 (271,948) 63,366
11 335,314
 (319,472) 15,842
 335,314
 (303,630) 31,684
Bioject(c)2 – 15 5,100,000
 (1,735,556) 3,364,444
 5,100,000
 (1,405,556) 3,694,444
2 – 15 5,100,000
 (2,028,889) 3,071,111
 5,100,000
 (1,882,222) 3,217,778
Other(d)18 4,050,000
 (3,018,750) 1,031,250
 4,050,000
 (2,906,250) 1,143,750
18 4,050,000
 (3,243,750) 806,250
 4,050,000
 (3,131,250) 918,750
Total intangible assets 24,717,873
 (19,424,602) 5,293,271
 24,717,873
 (18,708,144) 6,009,729
 24,717,873
 (20,490,854) 4,227,019
 24,717,873
 (19,957,728) 4,760,145
Total goodwill and intangible assets $35,231,244
 $(19,424,602) $15,806,642
 $35,231,244
 $(18,708,144) $16,523,100
 $35,231,244
 $(20,490,854) $14,740,390
 $35,231,244
 $(19,957,728) $15,273,516

(a)Goodwill was recorded from the Inovio AS acquisition in January 2005, the acquisition of VGX in June 2009 and the acquisition of Bioject in April 2016 for $3.9 million, $6.2 million and $400,000, respectively.
(b)
CELLECTRA® and GHRH are developed technologies which were recorded from the acquisition of VGX.
(c)Bioject intangible assets represent the estimated fair value of developed technology and intellectual property which were recorded from the Bioject asset acquisition.
(d)Other intangible assets represent the estimated fair value of acquired intellectual property from the Inovio AS acquisition.
Aggregate amortization expense on intangible assets for the three and six months ended June 30, 20182019 was $312,000$267,000 and $716,000,$533,000, respectively. Aggregate amortization expense on intangible assets for the three and six months ended June 30, 20172018 was $404,000$312,000 and $811,000,$716,000, respectively. Estimated aggregate amortization expense is $533,000 for the remainder of fiscal

year 2018, $1.1 million for 2019, $547,000 for 2020, $520,000 for 2021, $493,000 for 2022, $276,000 for 2023 and $2.1$1.9 million for 20232024 and subsequent years combined.

9. Convertible Senior Notes
On February 19, 2019 and March 1, 2019, the Company completed a private placement of $78.5 million aggregate principal amount of its 6.50% convertible senior notes due 2024 (the “Notes”). The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.7 million.
The Notes are senior unsecured obligations of the Company and accrue interest payable in cash semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2019, at a rate of 6.50% per annum. The Notes will mature on March 1, 2024, unless earlier converted, redeemed or repurchased.  Prior to the close of business on the business day immediately preceding November 1, 2023, the Notes will be convertible at the option of the holders only upon the satisfaction of certain circumstances. Thereafter, the Notes will be convertible at the option of the holders at any time until the close of business on the scheduled trading day immediately before the maturity date. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The initial conversion rate will be 185.8045 shares per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $5.38 per share), subject to adjustment upon the occurrence of specified events.
The Company may not redeem the Notes prior to March 1, 2022. On or after March 1, 2022, the Company may redeem all, or any portion, of the Notes for cash if the last reported sale price per share of the Company's common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such redemption notice. The redemption price will be equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The Company evaluated the accounting for the issuance of the Notes and concluded that the embedded conversion features meet the requirements for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its condensed consolidated balance sheet, and that the cash conversion guidance applies. Therefore, the Notes issuance proceeds of $78.5 million are allocated first to the liability component based on the fair value of non-convertible debt with otherwise identical residual terms with the residual proceeds allocated to equity for the conversion features. The Company determined that the fair value of the non-convertible debt upon issuance of the Notes was $62.2 million and recorded this amount as a liability and the offsetting amount as a debt discount as a reduction to the carrying value of the Notes on the closing date. The debt issuance costs associated with the Notes of $2.8 million are allocated to the liability and equity component in the same proportion as the issuance proceeds.
The Company determined that all other features of the Notes were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements.
The balance of the Notes at June 30, 2019 is as follows:
Principal amount$78,500,000
Unamortized debt discount on the liability component(15,436,340)
Unamortized debt issuance cost(2,124,567)
Accrued interest1,818,193
     Net carrying amount$62,757,286

The Company determined that the expected life of the Notes was equal to the period through November 1, 2023 as this represents the point at which the Notes are initially subject to repurchase by the Company at the option of the holders. Accordingly, the total debt discount of $18.6 million, inclusive of the fair value of the embedded conversion feature derivative at issuance, is being amortized using the effective interest method through November 1, 2023. The effective interest rate of the liability component is 13.1%. For the three and six months ended June 30, 2019, the Company recognized $2.2 million and $2.9 million, respectively, of interest expense related to the Notes, of which $1.4 million and $1.8 million, respectively, related to the contractual interest coupon. As of June 30, 2019, there have not been any conversions or redemptions of the Notes.

10. Stockholders’ Equity
The following is a summary of the Company's authorized and issued common and preferred stock as of June 30, 20182019 and December 31, 2017:2018:
    Outstanding as of    Outstanding as of
Authorized Issued June 30, 2018 December 31, 2017Authorized Issued June 30, 2019 December 31, 2018
Common Stock, par value $0.001 per share600,000,000
 91,474,395
 91,474,395
 90,357,644
600,000,000
 98,584,371
 98,584,371
 97,225,810
Series C Preferred Stock, par value $0.001 per share1,091
 1,091
 23
 23
1,091
 1,091
 23
 23
Common Stock
In May 2018, the Company entered into an At-the-Market Equity Offering Sales Agreement (the “Sales Agreement”) with an outside placement agent (the “Placement Agent”) to sell shares of its common stock with aggregate gross proceeds of up to $100.0 million, from time to time, through an “at-the-market” equity offering program under which the Placement Agent will act as sales agent. Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The Sales Agreement provides that the Placement Agent will be entitled to compensation for its services in an amount equal to up to 3.0% of the gross proceeds from the sales of shares sold through the Placement Agent under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement.
During the three and six months ended June 30, 2018,2019, the Company sold a total of 92,479476,600 and 659,800 shares of common stock, respectively, under the Sales Agreement. The sales were made at a weighted average price of $4.52$2.97 and $3.55 per share, respectively, resulting in aggregate net proceeds of $410,000.$1.4 million and $2.3 million, respectively. The Company may sell up to an additional $99.6$69.7 million in shares of its common stock under the Sales Agreement. The registration statement that registered with the SEC the shares that may be sold under the Sales Agreement expires on June 8, 2021.
In June 2016, the Company entered into an At-the-Market Equity Offering Sales Agreement (the “Prior Sales Agreement”) with the same placement agent. During the six months ended June 30, 2018, the Company sold a total of 314,950 shares of common stock under the Prior Sales Agreement. The sales were made at a weighted average price of $5.07 per share resulting in aggregate net proceeds of $1.6 million. During the six months ended June 30, 2017, the Company sold a total of 2,917,725 shares of common stock under the Prior Sales Agreement. The sales were made at a weighted average price of $8.41 per share resulting in aggregate net proceeds of $24.1 million. The registration statement that registered with the SEC the shares sold under the Prior Sales Agreement expired on June 5, 2018,Stock Options and no further sales will be made under the Prior Sales Agreement. The Company sold an aggregate of 3,911,104 shares of common stock under the Prior Sales Agreement resulting in aggregate net proceeds of $32.1 million.
On July 25, 2017, the Company closed an underwritten public offering of 12,500,000 shares of common stock at a public offering price of $6.00 per share. The net proceeds to the Company, after deducting the underwriters' discounts and commissions and other offering expenses, were $70.1 million.
Warrants
The Company accounts for registered common stock warrants issued in March 2013 under the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities laws, the registered warrants require the issuance of registered securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. The Company classifies registered warrants on the condensed consolidated balance sheet as a current liability which is revalued at each balance sheet date subsequent to the initial issuance. Determining the appropriate fair-value model and calculating the fair value of registered warrants requires considerable judgment, including estimating stock price volatility and expected warrant life. The Company uses the Black-Scholes pricing model to value the registered warrants. The Company develops its estimates based on historical data. A small change in the estimates used may have a relatively large change in the estimated valuation. Changes in the fair market value of the warrants are reflected in the condensed consolidated statement of operations as change in fair value of common stock warrants.
The following table summarizes the warrants outstanding as of June 30, 2018 and December 31, 2017:
Restricted Stock Units

      As of June 30, 2018 As of December 31, 2017
Issued in Connection With: 
Exercise
Price
 
Expiration
Date
 
Number of
Warrants Outstanding
 
Common Stock
Warrant Liability
 
Number of
Warrants Outstanding
 
Common Stock
Warrant Liability
March 2013 financing $3.17
 September 12, 2018 284,091
 $228,665
 284,091
 $360,795
Total     284,091
 $228,665
 284,091
 $360,795
Stock Options
The Company has a stock-based incentive plan, the 2016 Omnibus Incentive Plan (the(as amended to date, the "2016 Incentive Plan"), pursuant to which the Company may grant stock options, restricted stock awards, restricted stock units and other stock-based awards or short-term cash incentive awards to employees, directors and consultants.
The 2016 Incentive Plan was originally approved by the Company's stockholders on May 13, 2016.2016, and an amendment to the plan to increase the number of shares available for issuance was approved by the stockholders on May 8, 2019. The maximum number of shares of the Company’s common stock available for issuance over the term of the 2016 Incentive Plan may not exceed 6,000,00016,000,000 shares, provided that commencing with the first business day of each calendar year beginning January 1, 2018,2020, such maximum number of shares shall be increased by 2,000,000 shares of common stock unless the Board determines, prior to January 1 for any such calendar year, to increase such maximum amount by a fewer number of shares or not to increase the maximum amount at all for such year. On January 1, 2018, the maximum number of shares to be issued was increased by 2,000,000. At June 30, 2018,2019, there were 8,000,00016,000,000 shares of common stock reserved for issuance upon exercise of incentive awards granted and to be granted at future dates under the 2016 Incentive Plan. At June 30, 2018,2019, the Company had 2,914,3168,065,073 shares of common stock available for future grant under the 2016 Incentive Plan, 1,568,3811,573,526 shares underlying outstanding but unvested restricted stock units and options outstanding to purchase 3,159,7065,222,849 shares of common stock under the 2016 Incentive Plan. The awards granted and available for future grant under the 2016 Incentive Plan generally vest over three years and have a maximum contractual term of ten years. The 2016 Incentive Plan terminates by its terms on March 9, 2026.
The Amended and Restated 2007 Omnibus Incentive Plan (the "2007 Incentive Plan") was adopted on March 31, 2007 and terminated by its terms on March 31, 2017. At June 30, 2018,2019, the Company had 192,3296,666 shares underlying outstanding but unvested restricted stock units and options outstanding to purchase 5,894,8375,547,470 shares of common stock under the 2007 Incentive Plan. The awards granted under the 2007 Incentive Plan generally vest over three years and have a maximum contractual term of ten years.
At June 30, 2018, the Company had options outstanding to purchase 191,438 shares of common stock under the VGX Equity Compensation Plan. The options under this plan were assumed in connection with the acquisition of VGX. The terms and conditions of the options outstanding under this plan remain unchanged.

10.11. Net Loss Per Share
Basic net loss per share is computed by dividing the net loss for the year by the weighted average number of common shares outstanding during the year. Diluted net loss per share is calculated in accordance with the treasury stock method for the outstanding stock options and restricted stock units and reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock. For the three and six months ended June 30, 2019, the dilutive impact of the outstanding Notes issued by the Company (discussed in Note 9) has been considered using the "if-converted" method. For the three and six months ended June 30, 2019, basic and diluted net loss per share are the same, as the assumed exercise or settlement of stock options, restricted stock units and the potentially dilutive shares issuable upon conversion of the Notes are anti-dilutive. The calculation of diluted net loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the options, warrants or other securities and the presumed exercise of such securities are dilutive to net loss per share for the period, an adjustment to net loss used in the calculation is required to remove the change in fair value of such securities from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method.
The following tables reconcile the components of the numerator and denominator included in the calculations of diluted net loss per share:
 Three Months Ended June 30,
 2019 2018
Numerator   
Net loss$(29,387,226) $(6,639,125)
Adjustment for decrease in fair value of warrant liability
 (259,971)
Numerator for use in diluted net loss per share$(29,387,226) $(6,899,096)
    
Denominator   
Weighted average number of common shares outstanding98,083,896
 91,153,776
Effect of dilutive potential common shares
 87,884
Denominator for use in diluted net loss per share98,083,896
 91,241,660
    
Net loss per share, diluted$(0.30) $(0.08)

Three Months Ended June 30,Six Months Ended June 30,
2018 20172019 2018
Numerator      
Net loss$(6,639,125) $(9,479,116)$(58,606,488) $(38,989,953)
Adjustment for decrease in fair value of warrant liability(259,971) 

 (132,130)
Numerator for use in diluted net loss per share$(6,899,096) $(9,479,116)$(58,606,488) $(39,122,083)
      
Denominator      
Weighted average number of common shares outstanding91,153,776
 75,409,702
97,795,910
 90,804,722
Effect of dilutive potential common shares87,884
 

 86,070
Denominator for use in diluted net loss per share91,241,660
 75,409,702
97,795,910
 90,890,792
      
Net loss per share, diluted$(0.08) $(0.13)$(0.60) $(0.43)
 Six Months Ended June 30,
 2018 2017
Numerator   
Net loss$(38,989,953) $(32,565,023)
Adjustment for decrease in fair value of warrant liability(132,130) 
Numerator for use in diluted net loss per share$(39,122,083) $(32,565,023)
    
Denominator   
Weighted average number of common shares outstanding90,804,722
 74,783,791
Effect of dilutive potential common shares86,070
 
Denominator for use in diluted net loss per share90,890,792
 74,783,791
    
Net loss per share, diluted$(0.43) $(0.44)

The following table summarizes potential shares of common stock that were excluded from the diluted net loss per share calculation because of their anti-dilutive effect for the three and six months ended June 30, 20182019 and 2017:2018:
  
Common Stock Equivalents2018 20172019 2018
Options to purchase common stock9,245,981
 7,888,763
10,770,319
 9,245,981
Warrants to purchase common stock
 284,091
Restricted stock units1,760,710
 1,335,744
1,580,192
 1,760,710
Convertible preferred stock8,456
 8,456
8,456
 8,456
Convertible notes14,585,653
 
Total11,015,147
 9,517,054
26,944,620
 11,015,147

11.12. Stock-Based Compensation
The Company incurs stock-based compensation expense related to restricted stock units and stock options. The fair value of restricted stock is determined by the closing price of the Company's common stock reported on the Nasdaq Global Select Market on the date of grant. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life. The Company amortizes the fair value of the awards on a straight-line basis over the requisite vesting period of the awards. Expected volatility is based on historical volatility. The expected life of options granted is based on historical expected life. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is based on the fact that no dividends have been

paid historically and none are currently expected to be paid in the foreseeable future. Upon adoption of ASU 2016-09 on January 1, 2017, the Company elected to remove the forfeiture rate from the calculation and recorded a cumulative catch-up adjustment to accumulated deficit with a corresponding offset to additional paid-in-capital of $312,000. Previously, the forfeiture rate was based on historical data and the Company recorded stock-based compensation expense only for those awards that were expected to vest.
The weighted average assumptions used in the Black-Scholes model for option grants to employees and directors are presented below:
Three Months Ended June 30, Six Months Ended June 30,Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 20172019 2018 2019 2018
Risk-free interest rate2.81% 1.97% 2.73% 2.22%2.31% 2.81% 2.43% 2.73%
Expected volatility71% 73% 72% 73%70% 71% 70% 72%
Expected life in years6.1 6.0 6.2 6.06.2 6.1 6.2 6.2
Dividend yield      

Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2019 was $3.1 million and $6.3 million, respectively, of which $2.3 million and $4.2 million, respectively, was included in research and development expenses, and $877,000 and $2.1 million, respectively, was included in general and administrative expenses.

Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2018 was $2.4 million and $5.8 million, respectively, of which $1.4 million and $3.5 million, respectively, werewas included in research and development expenses, and $1.0 million and $2.3 million, respectively, were included in general and administrative expenses.
Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2017 was $2.4 million and $7.7 million, respectively, of which $1.2 million and $3.5 million, respectively, were included in research and development expenses, and $1.2 million and $4.2 million, respectively, were included in general and administrative expenses.
At June 30, 2018,2019, there was $7.7$6.0 million of total unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.0 years.
The weighted average grant date fair value per share, calculated using the Black-Scholes option pricing model, was $2.44 and $2.20 for employee and director stock options granted during the three and six months ended June 30, 2019, respectively, and $3.00 and $2.85 for employee and director stock options granted during the three and six months ended June 30, 2018, respectively, and $4.67 and $4.39 for employee and director stock options granted during the three and six months ended June 30, 2017, respectively.
At June 30, 2018,2019, there was $7.5$4.9 million of total unrecognized compensation expense related to unvested restricted stock units, which is expected to be recognized over a weighted-average period of 2.11.9 years.
The weighted average grant date fair value per share was $3.90 and $3.42 for restricted stock units granted during the three and six months ended June 30, 2019, respectively, and $4.57 and $4.31 for restricted stock units granted during the three and six months ended June 30, 2018, respectively, and $7.14 and $6.70respectively.
The Company adopted ASU 2018-07 on January 1, 2019, which generally aligned the accounting for restricted stock units granted during the three and six months ended June 30, 2017, respectively.
stock-based compensation for non-employees with that of employees. The fair value of stock options granted to non-employees at the measurement dates werewas estimated using the Black-Scholes pricing model. Total stock-based compensation expense for stock options and restricted stock units granted to non-employees for the three and six months ended June 30, 20182019 was $35,000$207,000 and $174,000,$480,000, respectively. Total stock-based compensation expense for stock options and restricted stock units granted to non-employees for the three and six months ended June 30, 20172018 was $118,000$35,000 and $249,000,$174,000 respectively.

12.13. Related Party Transactions
GeneOne Life Sciences
The Company owns 1,644,155 shares of common stock in GeneOne as of June 30, 2018;2019 and one of the Company's directors, Dr. David B. Weiner, acts as a consultant to GeneOne.
In 2010, the Company entered into a collaboration and license agreement (the “GeneOne Agreement”) with GeneOne. Under the GeneOne Agreement, the Company granted GeneOne an exclusive license to the Company's SynCon® universal influenza vaccine delivered with electroporation to be developed in certain countries in Asia (the “Product”). As consideration for the license granted to GeneOne, the Company received an upfront payment of $3.0 million, and is entitled to receive research support, annual license maintenance fees and royalties on net Product sales. The GeneOne Agreement also provides the Company with exclusive rights to supply devices for clinical and commercial purposes (including single use components) to GeneOne for use in the Product. The term of the GeneOne Agreement commenced upon execution and will extend on a country by country basis until the last to expire of all Royalty Periods for the territory (as such term is defined in the GeneOne

Agreement) for any Product in that country, unless the GeneOne Agreement is terminated earlier in accordance with its provisions as a result of breach, by mutual agreement, or by GeneOne's right to terminate without cause upon prior written notice.
In 2011, the Company entered into a collaborative development and license agreement (the “Hep Agreement”) with GeneOne. Under the Hep Agreement, as originally executed, the Company and GeneOne agreed to co-develop the Company’s SynCon® therapeutic vaccines for hepatitis B and C infections (the “Hep Products”). Under the terms of the Hep Agreement, GeneOne will receive marketing rights for the Products in Asia, excluding Japan, and in return will fully fund IND-enabling and initial Phase 1 and 2 clinical studies with respect to the Hep Products. The Company will receive from GeneOne payments based on the achievement of clinical milestones and royalties based on sales of the Hep Products in the licensed territories, retaining all commercial rights to the Hep Products in all other territories. In 2013, the Company amended the Hep Agreement to grant back to the Company the SynCon® therapeutic vaccines targeting hepatitis B, along with all associated rights, from the collaboration in return for certain remuneration including a percentage of license fees. In 2013, the Company further amended the Hep Agreement to in part provide exclusive patent rights to IL-28 technology for use with the Hep Products in Asia, excluding Japan. The Hep Agreement shall terminate upon the later of the expiration or abandonment of the last patent that is a component of the rights or 20 years after the effective date.
In May 2015, the Company entered into a Collaborative Development Agreement with GeneOne to co-develop a DNA vaccine for MERS through Phase 1 clinical trials. Under the terms of the agreement, GeneOne will be responsible for funding all preclinical and clinical studies through Phase 1. In return, GeneOne will receive up to a 35% milestone-based ownership interest in the MERS immunotherapy upon achievement of the last milestone event of completion of the Phase 1 safety and

immunogenicity study. The collaborative research program shall terminate upon the completion of activities under the development plan, unless sooner terminated.
In January 2016, the Company and GeneOne amended the Collaborative Development Agreement for MERS to expand the agreement to test and advance the Company's DNA-based vaccine for preventing and treating Zika virus. GeneOne will be responsible for funding all preclinical and clinical studies through Phase 1. In return, GeneOne will receive up to a 35% milestone-based ownership interest in the Zika immunotherapy upon achievement of the last milestone event of the completion of the Phase 1 safety and immunogenicity study. All other agreement terms remain the same.
In December 2017, the Company completed the sale of certain assets related to its compound VGX-1027 to GeneOne for a purchase price of $1.0 million.
Revenue recognized from GeneOne consisted of licensingpatent and other fees from the influenza and Zika collaborations.device maintenance fees. For the three and six months ended June 30, 2018,2019, the Company recognized revenue from GeneOne of $31,000 and $63,000, respectively, and $32,000 and $150,000 respectively, and $155,000 and $322,000 for the three and six months ended June 30, 2017, respectively.
Operating expenses recorded from transactions with GeneOne relate primarily to biologics manufacturing. Operating expenses from GeneOne for the three and six months ended June 30, 2018, respectively.
Operating expenses recorded from transactions with GeneOne related primarily to biologics manufacturing were $1.1 million$727,000 and $2.8 million, respectively, and $722,000 and $1.2$1.8 million for the three and six months ended June 30, 2017,2019, respectively and $1.1 million and $2.8 million for the three and six months ended June 30, 2018, respectively.
At June 30, 20182019 and December 31, 2017,2018, the Company had an accounts receivable balance of $31,000$128,000 and $0, respectively, and an accounts payable and accrued liability balance of $75,000$107,000 and $107,000,$372,000, respectively, related to GeneOne and its subsidiaries. At June 30, 20182019 and December 31, 2017, $322,0002018, $344,000 and $331,000,$381,000, respectively, of prepayments made to GeneOne were classified as long-term other assets on the Company's condensed consolidated balance sheet.
Plumbline Life Sciences, Inc.
The Company owns 395,758 shares of common stock in Plumbline Life Sciences, Inc. ("PLS") as of June 30, 2018;2019 and one of the Company's directors, Dr. David B. Weiner, acts as a consultant to PLS.
In August 2016, the Company licensed a veterinary vaccine for foot and mouth disease ("FMD") to PLS. PLS will fund all development activities for this FMD vaccine. The Company will receive milestone payments as well as royalties on product sales from PLS for commercial rights to this FMD synthetic vaccine in Asia, excluding Japan.
For the three and six months ended June 30, 2018,2019, the Company recognized revenue from PLS of $40,000 and $64,000, respectively, and $28,000 and $58,000 respectively, and $21,000 and $88,000 for the three and six months ended June 30, 2017,2018, respectively. At June 30, 20182019 and December 31, 2017,2018, the Company had an accounts receivable balance of $429,000$542,000 and $370,000,$478,000, respectively, related to PLS.
The Wistar Institute
OneTwo of the Company's directors, Dr. David B. Weiner is the Executive Vice President and DirectorDr. Morton Collins, are Directors of the Vaccine Center of The Wistar Institute ("Wistar"). Dr. Weiner is also the Executive Vice President of Wistar.
In March 2016, the Company entered into collaborative research agreements with Wistar for preventive and therapeutic DNA-based immunotherapy applications and products developed by Dr. Weiner and Wistar for the treatment of cancers and

infectious diseases. Under the terms of the agreement, the Company will reimburse Wistar for all direct and indirect costs incurred in the conduct of the collaborative research, not to exceed $3.1 million during the five-year term of the agreement. The Company will have the exclusive right to in-license new intellectual property developed under the agreement.
In DecemberNovember 2016, the Company received a $6.1 million sub-grant through Wistar to develop a DNA-based monoclonal antibody against the Zika infection.infection, with funding through July 2020.
The Company is also a collaborator with Wistar on an Integrated Preclinical/Clinical AIDS Vaccine Development grant from the NIAID, awarded in 2015.with funding through February 2020.
Deferred grant funding recognized from Wistar and recorded as contra-research and development expense which would have been classified as grant revenue in the prior year, is related to work performed by the Company on the research sub-contract agreements. For the three and six months ended June 30, 2019, the Company recorded $368,000 and $1.2 million, respectively, and for the three and six months ended June 30, 2018 the Company recorded $455,000 and $2.2 million, respectively, as contra-research and development expense from Wistar. For the three and six months ended June 30, 2017, the Company recognized revenue from Wistar of $1.1 million and $1.7 million, respectively.
Research and development expenses recorded from Wistar relate primarily to the collaborative research agreements and sub-contract agreements related to the DARPA Ebola grantBill and Melinda Gates Foundation and CEPI (see Note 14)15). Research and development expenses recorded from Wistar for the three and six months ended June 30, 2019 were $170,000 and $458,000, respectively. Research and development expenses recorded from Wistar for the three and six months ended June 30, 2018 were $399,000 and $802,000, respectively. Research and development expenses recorded from Wistar for the three and six months ended June 30, 2017 were $485,000 and $1.0 million, respectively. At June 30, 20182019 and December 31, 2017,2018, the Company had an accounts receivable balance of $500,000$327,000 and $117,000,$258,000, respectively, and an accounts payable and accrued liability balance of $526,000$546,000 and $820,000,$554,000, respectively, related to Wistar.

13. Commitments and Contingencies
San Diego Leases
In April 2013, As of June 30, 2019, the Company entered into a lease for office space located in San Diego, California (the "San Diego Lease"). The term of the San Diego Lease commenced on December 1, 2013. The initial term of the San Diego Lease is ten years, with a right to terminate on December 1, 2019, subject to specified conditions. In June 2015, the Company amended the San Diego Lease to increase the total leased space and occupy the entire building. The commencement of the amended San Diego Lease was in January 2016 and increased monthly lease payments to range from zero to $99,000. The Company has capitalized $3.4 million of total tenant improvements within fixed assetshad $844,000 recorded as deferred grant funding on the condensed consolidated balance sheet related to the entire buildingWistar.

14. Leases
The Company leases approximately 82,200 square feet of office, laboratory, and has recorded a corresponding increase to deferred rent.
In October 2016, the Company entered into an office lease (the “new Lease”) for a second property locatedmanufacturing space in San Diego, California. The totalCalifornia and 57,360 square feet of office space in Plymouth Meeting, Pennsylvania under various non-cancellable operating lease agreements with remaining lease terms of 4.4 to 10.5 years, which represent the new Lease is approximately 51,000 square feet. The Company is using the facility for office, manufacturing and research and development purposes. The termnon-cancellable periods of the new Lease commenced on June 1, 2017. The initial term of the new Lease is ten years, with a right to terminate on November 30, 2023, subject to specified conditions.leases.
The base rent adjusts periodically throughout the term of the new Lease, with monthly payments ranging from zero to $95,000, with a portion of the rent abated for certain periods during the first two years of the initial term. In addition, the Company is obligated to reimburse the landlord its share of operating and other expenses, and has paid a security deposit of $95,000.
The Company has capitalized $2.3 millionexcluded the extension options from its lease terms in the calculation of reimbursablefuture lease payments as they are not reasonably certain to be exercised. The Company's lease payments consist primarily of fixed rental payments for the right to use the underlying leased assets over the lease terms as well as payments for common area maintenance and administrative services. The Company has received customary incentives from its landlords, such as reimbursements for tenant improvements toand rent abatement periods, which effectively reduce the new office whichtotal lease payments owed for these leases.
The Company has been recorded asevaluated all of its leases and determined that, effective upon the adoption of Topic 842, they were all operating leases. The Company performed an evaluation of its other contracts with customers and suppliers in accordance with Topic 842 and determined that, except for the real estate leases described above and various copier leases, none of its other contracts contain a leasehold improvement within fixedright-of-use asset.
Operating lease right-of-use assets and liabilities on the condensed consolidated balance sheet offset by a corresponding amount recordedrepresents the present value of the remaining lease payments over the remaining lease terms. Payments for additional monthly fees to cover the Company's share of certain facility expenses are not included in deferred rent.
Plymouth Meeting Lease
In March 2014, the Company entered into aoperating lease (the "Lease") for office space located in Plymouth Meeting, Pennsylvania.right-of-use assets and liabilities. The Company occupieduses its incremental borrowing rate to calculate the spacepresent value of its lease payments, as the implicit rates in the leases are not readily determinable.
As of June 2014. The initial term30, 2019, the maturities of the Company's operating lease liabilities were as follows:
Remainder of 2019$1,915,000
20203,891,000
20213,979,000
20224,052,000
20234,023,000
Thereafter15,952,000
   Total remaining lease payments33,812,000
Less: present value adjustment(10,379,000)
   Total operating lease liabilities23,433,000
Less: current portion(1,949,000)
Long-term operating lease liabilities$21,484,000
  
Weighted-average remaining lease term8.7 years
Weighted-average discount rate8.4%
Lease is 11.5 years.
The base rent adjusts periodically throughout the term of the Lease, with monthly payments ranging from zero to $58,000. In addition, the Company is obligated to reimburse the landlord its share ofcosts included in operating and other expenses and a property management fee, and has paid a security deposit of $49,000. In July 2015 and June 2016, the Company amended the Lease to increase the total leased space. The commencement of the amended Lease in July 2015 was in the first quarter of 2016 and increased monthly lease payments to range from zero to $80,000. The commencement of the amended lease in June 2016 was October 1, 2017 and increased monthly lease payments to range from $75,000 to $90,000.
In June 2017, the Company entered into another amendment to the Lease to extend the lease term through December 31, 2029. In connection with this amendment, the Company paid the landlord an additional security deposit of $75,000. Total monthly rent payments for the additional term will range between $173,000 and $179,000. The future monthly lease payments for all the Plymouth Meeting office space will range from zero to $179,000. The Company has capitalized $2.6 million of tenant improvements to the Plymouth Meeting office within fixed assets on the condensed consolidated balance sheet, offset by a corresponding amount recordedstatements of operations for the three and six months ended June 30, 2019 were $835,000 and $1.7 million, respectively. Lease costs included in deferred rent.

The Company's future minimum lease payments under all non-cancelable operating leases asexpenses in the condensed consolidated statements of operations for the three and six months ended June 30, 2018 were $941,000 and $1.6 million, respectively. Operating lease costs consisting of the fixed lease payments included in operating lease liabilities are recorded on a straight-line basis over the lease terms. Variable lease costs are recorded as follows:

Remainder of 2018$1,642,000
20193,756,000
20203,891,000
20213,979,000
20224,052,000
Thereafter19,975,000
Total$37,295,000

incurred.
In the normal course of business, the Company is a party to a variety of agreements pursuant to which it may be obligated to indemnify the other party. It is not possible to predict the maximum potential amount of future payments under these types of agreements due to the conditional nature of the Company's obligations and the unique facts and circumstances involved in each particular agreement. Historically, payments made by usthe Company under these types of agreements have not had a material effect on the Company'sits business, consolidated results of operations or financial condition.


14.15. Collaborative Agreements
ApolloBio Corporation
On December 29, 2017, the Company entered into an Amended and Restated License and Collaboration Agreement (the "ApolloBio Agreement"), with ApolloBio Corporation ("ApolloBio"), with an effective date of March 20, 2018. Under the terms of the ApolloBio Agreement, the Company has granted to ApolloBio the exclusive right to develop and commercialize VGX-3100, its DNA immunotherapy product designed to treat pre-cancers caused by HPV, within the territories of China, Hong Kong, Macao, Taiwan, and may include Korea in the event that no patent covering VGX-3100 is issued in China within the three years following the effective date of the ApolloBio Agreement.
Under the ApolloBio Agreement, the Company received proceeds of $19.4 million in March 2018 which comprised the up-frontupfront payment of $23.0 million less $2.2 million in foreign income taxes and $1.4 million in certain foreign non-income

taxes. The foreign income taxes were recorded as a provision for income taxes and the foreign non-income taxes were recorded as a general and administrative expense, on the condensed consolidated statement of operations during the quarter ended March 31, 2018. The Company also incurred advisory fees of $960,000 in connection with receiving the up-frontupfront payment from ApolloBio. These fees were determined to be incremental costs of obtaining the contract. The Company applied the practical expedient that permits a company to expense incremental costs to obtain a contract when the expected amortization period is one year or less and recorded the fees in general and administrative expense during the quarter ended March 31, 2018. No additional advisory fees are due related to the ApolloBio Agreement.
In addition to the upfront payment, the Company is entitled to receive up to an aggregate of $20.0 million, less required income, withholding or other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in the United States, China and Korea. In the event that VGX-3100 is approved for marketing, the Company will be entitled to receive royalty payments based on a tiered percentage of annual net sales, with such percentage being in the low- to mid-teens, subject to reduction in the event of generic competition in a particular territory. ApolloBio’s obligation to pay royalties will continue for 10 years after the first commercial sale in a particular territory or, if later, until the expiration of the last-to-expire patent covering the licensed products in the specified territory.
The Company evaluated the terms of the ApolloBio Agreement under Topic 606, and the license to VGX-3100 in the territories was identified as the only distinct performance obligation on a standalone basis as of the inception of the agreement. The Company concluded that the license was distinct from potential future manufacturing and supply obligations. The Company further determined that the transaction price under the agreement consisted of the $23.0 million upfront payment. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of the evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain at this time. Future potential milestone amounts may be recognized as revenue under the ApolloBio Agreement, as well as under other collaborative research and development arrangements, if unconstrained. Reimbursable program costs will be recognized proportionately with the performance of the underlying services or delivery of drug supply and are excluded from the transaction price.
The ApolloBio Agreement will continue in force until ApolloBio has no remaining royalty obligations. Either party may terminate the ApolloBio Agreement in the event the other party shall materially breach or default in the performance of its material obligations thereunder and such default continues for a specified period after written notice thereof. In addition, ApolloBio may terminate the ApolloBio Agreement at any time beginning one year after the effective date for any reason upon 90 days written notice to the CompanyCompany.
The Company identifiedUnder Topic 606, the promised goods or services at the effective dateentire transaction price of the ApolloBio agreement and determined that$23.0 million was allocated to the license to VGX-3100 in the territories represents a distinct performance obligation on a standalone basis.obligation. The Company has determined that during the three monthsquarter ended June 30, 2018, the transfer of technology occurred and accordingly, the performance obligation was fully satisfied. The Company has recorded the gross up-frontupfront payment received from ApolloBio of $23.0 million as revenue under collaborative research and development arrangements on the condensed consolidated statement of operations during the three months ended June 30, 2018.

MedImmuneAstraZeneca
On August 7, 2015, the Company entered into a license and collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca.AstraZeneca ("AstraZeneca"). Under the agreement, MedImmuneAstraZeneca acquired exclusive rights to the Company's INO-3112 immunotherapy, renamed as MEDI0457, which targets cancers caused by human papillomavirus (HPV) types 16 and 18, with the ability to sublicense those license rights. MedImmuneAstraZeneca made an upfront payment of $27.5 million to the Company in September 2015 and has agreed2015. AstraZeneca may be obligated to make potential future development and regulatory event-based payments to the Company totaling up to $355$125 million and potential future commercial event-based payments totaling up to $345$115 million, in each case upon the achievement of specified milestones set forth in the license and collaboration agreement. MedImmuneAstraZeneca will fund all development costs associated with INO-3112MEDI0457 immunotherapy. The Company is entitled to receive up to mid-single to double-digit tiered royalties on INO-3112MEDI0457 product sales. Within the broader collaboration, at MedImmune’s discretion, MedImmune and the Company will develop up to two additional DNA-based cancer vaccine products not included in the Company's current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. These additional development services would be provided by the Company at an industry standard full-time-equivalent rate. Under the agreement, MedImmuneAstraZeneca can also request the Company to provide certain clinical manufacturing at an agreed upon price. The Company determined these options did not represent material rights at the inception of the agreement.
Within the broader collaboration, AstraZeneca had rights to co-develop up to two additional DNA-based cancer vaccine product candidates not included in the Company's current product pipeline. The Company has received notice that AstraZeneca intends to discontinue activities with respect to the research collaboration programs, other than MEDI0457, that were covered by the collaboration agreement.
As of December 31, 2017, the Company had recognized all of the $27.5 million upfront payment as revenue, as all identified material performance obligations had been met with respect to that payment. In December 2017,During the three and six months ended June 30, 2019, the Company receivedrecognized revenues of $62,000 and recognized as revenue$2.8 million, respectively, from AstraZeneca primarily from a $7.0 million milestone payment from MedImmuneachieved in the first quarter of 2019 triggered by MedImmune’sthe initiation of thea Phase 2 portion of an ongoing clinical trial underin the agreement.

third major indication, as well as for manufacturing services. During the three and six months ended June 30, 2018, the Company recognized revenues of $1.4 million and $2.7 million, respectively, from MedImmuneAstraZeneca primarily for manufacturing services. As of June 30, 2018,2019, the Company had deferred revenue and accounts receivable of $156,000 and $78,000, respectively, related to MedImmune of $846,000 and $1.1 million, respectively.AstraZeneca. The deferred revenue relates to advanced payments made by the Company to a third-party biologics manufacturer for which MedImmuneAstraZeneca is obligated to pay.
Prior to January 1, 2018reimburse the Company accounted for the arrangement under Topic 605, which resulted in revenue of $14.2 million and $14.5 million from MedImmune for the three and six months ended June 30, 2017, respectively. 
Roche
In September 2013, the Company entered into a Collaborative, License, and Option Agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “Roche”) and received an upfront payment of $10.0 million. The parties agreed to co-develop multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B.
On November 14, 2014, Roche provided notice to the Company that it would be partially terminating the agreement with respect to the development of the Company’s DNA immunotherapy targeting prostate cancer. The termination was effective in February 2015. All of Roche’s rights to the Company’s DNA immunotherapy targeting prostate cancer, including the right to license the product to other parties, have been returned to the Company.
On July 28, 2016, Roche provided notice to the Company that it would be discontinuing the agreement and its development of INO-1800, the Company’s DNA immunotherapy against the hepatitis B virus. The termination was effective in October 2016. All of Roche’s rights to INO-1800, including the right to license the product to other parties, have been returned to the Company. In February 2017, the Company received full payment of $8.5 million from Roche for its past and future obligations which were completed during the quarter ended June 30, 2017, associated with the termination of the agreement. During the three and six months ended June 30, 2018, the Company recognized no revenues from Roche. During the three and six months ended June 30, 2017, the Company recognized revenues of $2.1 million and $6.1 million, respectively, from Roche.
Coalition for Epidemic Preparedness Innovations
On April 11, 2018, the Company announced that it has entered into agreements with the Coalition for Epidemic Preparedness Innovations ("CEPI"),CEPI, pursuant to which the Company intends to develop vaccine candidates against Lassa fever and MERS. The goal of the collaboration between the Company and CEPI is to conduct research and development so that investigational stockpiles will be ready for clinical efficacy trial testing during potential disease outbreaks. The agreements with CEPI contemplate preclinical studies, as well as Phase 1 and Phase 2 clinical trials, occurring over the next fewmultiple years. As part of the arrangement between the parties, CEPI has agreed to fund up to an aggregate of $56 million of costs over a five-year period for preclinical studies, as well as planned Phase 1 and Phase 2 clinical trials, to be conducted by the Company and collaborators, with funding from CEPI based on the achievement of identified milestones. The Company's vaccine candidate for Lassa fever will be knownDuring the three and six months ended June 30, 2019, the Company received funding of $1.5 million and $3.2 million, respectively, related to the CEPI grant and recorded it as INO-4500contra-research and its vaccine candidate for MERS will be known as INO-4700.development expense. During the three and six months ended June 30, 2018, the Company received funding of $834,000 related to the CEPI grant and recorded it as contra-research and development expense. As of June 30, 2018,2019, the Company had a deferred grant funding balance related to the CEPI grant of $2.4$2.3 million recorded as deferred grant funding on the condensed consolidated balance sheet.
DARPA- Ebolasheet related to the CEPI grant.

In April 2015,
16. Income Taxes
The Company uses an estimated annual effective tax rate, which is based on expected annual income, statutory tax rates and tax planning opportunities available in the various jurisdictions in which the Company receivedoperates, to determine its quarterly provision for income taxes. Certain significant or unusual items are separately recognized in the quarter in which they occur and can be a grantsource of variability in the effective tax rates from the Defense Advanced Research Projects Agency ("DARPA")quarter to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola.quarter. The consortium, led byincome tax benefit recorded during the Company, is taking a multi-faceted approach to develop products to prevent and treat Ebola infection. The award covers pre-clinical development costs as well as good manufacturing practice, manufacturing costs and the Phase 1 clinical study costs. The initial funding period covers a base award of $19.6 million and an option award of $24.6 million, which was exercised in September 2015. During the three and six months ended June 30, 2018,2019 is principally due to a requirement under ASC 740, Accounting for Income Taxes, that a company must consider all sources of income in order to determine the tax benefit resulting from a loss from continuing operations.  As a result of the requirement under ASC 740-20-45-7, the pretax income which the Company received fundinggenerated from other comprehensive income (loss) was a source of $496,000 and $872,000, respectively, related toincome which resulted in the DARPA grant and recorded it as contra-research and development expense.partial realization of the current year loss from continuing operations.  During the three and six months ended June 30, 2017, the Company recognized revenues of $2.7 million and $7.8 million, respectively, from DARPA related to the grant. As of June 30, 2018,2019 the Company has received total fundingrecorded a tax benefit of $43.4 million related to the DARPA grant. As of June 30, 2018, the Company had a deferred grant funding balanceapproximately $170,000 and accounts receivable balance of $130,000 and $569,000, respectively, related to the DARPA grant.an offsetting $335,000 charge included in other comprehensive income (loss).

17. Geneos Therapeutics, Inc.
In August 2016, the Company incorporated a subsidiary, Geneos Therapeutics, Inc. (“Geneos”), to develop and commercialize neoantigen-based personalized cancer therapies. In February 2019, the Company completed a spin-out of Geneos, after Geneos completed the initial closing of a $4.5 million preferred stock financing. The Company invested $1.2 million in the preferred stock financing, which was led by an outside investor. The terms of the stock purchase agreement include a commitment for an additional investment of $800,000 by the Company as well as commitments from the other investors upon the occurrence of a specified regulatory event, as well as an option for the Company to purchase $800,000 of additional preferred stock of Geneos upon the achievement of a specified milestone. Following the initial closing of the financing transaction, the Company holds 61% of the outstanding equity, on an as-converted to common stock basis, of Geneos. The Company's ownership percentage of Geneos would decrease in the event of additional purchases of preferred stock of Geneos by the other investors under the terms of the stock purchase agreement.
The Company has exclusively licensed its SynCon® immunotherapy and CELLECTRA® technology platform to Geneos to be used in the field of personalized, neoantigen-based therapy for cancer. The license agreement provides for potential royalty payments to the Company in the event that Geneos commercializes any products using the licensed technology.

18. Subsequent Events
On July 16, 2019, the Company announced a strategic organizational restructuring to focus on the commercial development of its late-stage HPV assets and reallocate capital to develop fast-to-market product candidates. In order to reduce operating expenses and conserve cash resources, the Company also announced a reduction of approximately 28% of its workforce and the discontinuation of its immuno-oncology Phase 1/2 study of INO-5401 in advanced bladder cancer. On July 12, 2019, the Company’s Board of Directors approved these actions, which were effective immediately. As a result, the Company expects to incur a personnel-related restructuring charge of approximately $2.3 million in connection with one-

time employee termination costs, including severance and other benefits, which is expected to be incurred primarily in the third quarter of 2019.
On August 1, 2019, the Company closed a private placement of 1.0% convertible bonds due 2024 with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm based in Seoul, Korea. The Company also announced its intent to pursue a listing of its securities on the KOSDAQ Market of the Korea Exchange (KOSDAQ) in the form of Korean Depositary Receipts (KDRs) representing shares of common stock.
The bonds, which are unsecured obligations of the Company, were issued on August 1, 2019 and will accrue interest at a coupon rate of 1.00% per annum, payable quarterly. The bonds will mature on July 31, 2024, unless earlier converted or repurchased. The outstanding bonds will be repaid at maturity at a price equal to the principal of the outstanding bonds to be repaid plus a premium on such bonds to provide an internal rate of return with respect to such bonds of 6.00%. Commencing on August 1, 2020, the bonds will be convertible until the date that is one month prior to maturity date. Upon conversion, the Company will deliver KDRs, if the Company has any such securities listed on the KOSDAQ at that time, or otherwise shares of common stock, if KDRs are not listed on KOSDAQ at that time or the converting holder requests delivery of shares of common stock. The initial conversion rate will be 211.0595 shares per KRW1,000,000 principal amount of bonds (equivalent to an initial conversion price of approximately USD $4.00 per share based on the exchange rate as of July 30, 2019), subject to adjustment upon the occurrence of specified events. The conversion rate is subject to reset on January 2, 2020 and on each three month anniversary thereafter until the maturity date to the then current market price if the current market price is lower than the conversion price then in effect; provided that the conversion rate will not exceed 351.7658 shares per KRW1,000,000 (equivalent to a conversion price of approximately USD $2.40 per share based on the exchange rates as of July 30, 2019).
The bonds will be subject to repurchase by the Company at the option of the bondholders from and including July 31, 2022 up to the date that is one month prior to the maturity date at a repurchase price equal to the principal of the bonds to be repurchased plus a premium on the bonds in order to provide an internal rate of return with respect to the bonds of 6.00%. In addition, upon the occurrence of a fundamental change (as defined in the bonds), the Company will be required to offer to repurchase the bonds at a repurchase price equal to the principal amount thereof plus accrued and unpaid interest thereon to but excluding the applicable repurchase date.
From July 1 through July 16, 2019, the Company sold 382,800 shares of common stock under its Sales Agreement for net proceeds of $1.1 million. The sales were made at a weighted average price of $3.01 per share.


ITEM 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report contains forward-looking statements, as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.
Although we believe that the expectations reflected in the forward-looking statements are reasonable based on our current expectations and projections, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We disclaim anyare under no obligation except as specifically required by law and the rules of the SEC, to publicly update or revise any of the forward-looking statements after the filing of this Quarterly Report to conform such statements to actual results or to changes in our expectations. Statements made herein are as of the date of the filing of this Quarterly Report with the SEC and should not be relied upon as of any subsequent date. We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made.
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes and other financial information appearing elsewhere in this Quarterly Report and our audited consolidated financial statements and related notes for the year ended December 31, 20172018 included in our Annual Report on Form 10-K filed with the SEC on March 14, 201812, 2019 (our “2017“2018 Annual Report”). Readers are also urged to carefully review and consider the various disclosures made by us that attempt to advise interested parties of the factors that affect our business, including without limitation the disclosures made in Item 1A of Part II of this Quarterly Report under the captions “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations,” and the disclosures made in our 20172018 Annual Report under the caption “Risk Factors” and in our audited consolidated financial statements and related notes.
Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our lack of products that have received regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results 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 desired results, that preclinical studies and clinical trials may not commence, have sufficient enrollment 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, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; our ability to receive development, regulatory and commercialization event-based payments under our collaborative agreements; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals.

General

We are developing active DNA immunotherapies and vaccinesan innovative clinical stage biotechnology company focused on treatingthe discovery, development, and preventingcommercialization of our synthetic DNA technology targeted against cancers and infectious diseases. Our DNA-based immunotherapies and vaccines, in combination with our proprietary, electroporationefficacy-enabling delivery devices, are intended to generate robust immune responses, in particular functional CD8+ killer T cells and antibodies, to fight targettargeted diseases. In September 2015, data was published in the medical journal The Lancet from a controlled Phase 2 clinical trial in which we generated significant, functional antigen-specific T cells that correlated to clinically relevant efficacy against HPV-associated cervical dysplasia (precancer). In June 2017, we began a Phase 3 clinical trial of our product candidate VGX-3100 for the treatment of HPV-caused cervical dysplasia. The Phase 3 trial for VGX-3100, which includes REVEAL 1, its primary study, and REVEAL 2, its confirmatory study, remains open and we are actively recruiting patients for REVEAL 1. A total of 69 sites globally are open to date and recruiting for REVEAL 1. We are also recruiting patients in a Phase 2 clinical trial of VGX-3100 for patients with vulvar dysplasia, or VIN, and associated diseases.
Our novel SynCon® immunotherapy design has shown the ability to help break the immune system’s tolerance of cancerous cells. Our SynCon® product design approach is also intended to facilitate cross-strain protection against known and new unmatched strains of pathogens, such as influenza. GivenOur CELLECTRA® delivery system facilitates optimized cellular uptake of the recognized roleSynCon® immunotherapies, overcoming a key limitation of CD8+ killer T cells in eliminating cancerous or infected cells from the body and the published results from our Phase 2 clinical trial, we believe that our active immunotherapies may play an important role in helping fight multiple cancers and infectious diseases.other DNA-based immunotherapies. Human data to date have shown a favorable safety profile of our DNASynCon® immunotherapies delivered using electroporation.CELLECTRA® in over 6,000 administrations across almost 2,000 patients.
We or our collaborators are currently conducting or planning clinical studies of our proprietary SynCon® immunotherapies for HPV-caused pre-cancers, including cervical, vulvar, and anal and vulvar neoplasia;dysplasia; HPV-caused cancers, including head & neck, cervical, anal, penile, vulvar, and cervical; bladder cancer;vaginal; other HPV-caused disorders, such as recurrent respiratory papillomatosis, or RRP; glioblastoma multiforme, or GBM; prostate cancer, breast, lung and pancreatic cancers; hepatitis C virus, or HCV;cancer; hepatitis B virus; or HBV;hepatitis C virus; HIV; Ebola; Middle East Respiratory Syndrome, or MERS; Lassa fever; and Zika virus. InWe also recently announced our intention to

accelerate the second quarter of 2018, we opened sites for a Phase 1/2a clinical trial to evaluate the safety, immunogenicity and preliminary clinical efficacydevelopment of our product candidates INO-5401DNA-encoded bi-specific T cell engagers, or dBTE, technology and INO-9012, in combinationbuild on recent advances observed with Genentech’s atezolizumab, in participants with locally advanced unresectableour DNA-encoded monoclonal antibody, or metastatic/recurrent urothelial carcinoma (bladder cancer). In addition, during the second quarter of 2018, we opened sites for a Phase 1/2 clinical trial to evaluate the safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012, in combination with Regeneron’s cemiplimab, in patients with newly diagnosed GBM.dMAb, technology.
In April 2018, we entered into agreements with the Coalition for Epidemic Preparedness Innovations, or CEPI, pursuant to which we intend to develop vaccine candidates against Lassa fever and MERS. The goal of the collaboration is to conduct research and development so that investigational stockpiles will be ready for clinical efficacy trial testing during potential disease outbreaks. The agreements with CEPI contemplate preclinical studies, as well as Phase 1 and Phase 2 clinical trials, occurring over the next few years. As part of the arrangement, CEPI has agreed to fund up to an aggregate of $56 million of costs over a five-year period for preclinical studies, as well as planned Phase 1 and Phase 2 clinical trials, to be conducted by us and our collaborators, with funding from CEPI based on the achievement of identified milestones. Our vaccine candidate for Lassa fever will be known as INO-4500 and our vaccine candidate for MERS will be known as INO-4700.
In December 2017, we entered into an Amended and Restated License and Collaboration Agreement, or the ApolloBio Agreement, with ApolloBio Corporation, or ApolloBio. Under the terms of the ApolloBio Agreement, we have granted to ApolloBio the exclusive right to develop and commercialize VGX-3100 within the territories of China, Hong Kong, Macao, Taiwan and potentially Korea. In March 2018, upon the ApolloBio Agreement becoming effective, we received an upfront payment of $23.0 million, which was reduced by an aggregate of $3.6 million in foreign income taxes and certain foreign non-income taxes required to be withheld from the payment, resulting in net proceeds of $19.4 million to us. We also incurred advisory fees of $960,000 in connection with receiving the up-front payment. No additional advisory fees are due related to the ApolloBio Agreement. In addition to the upfront payment, we are entitled to receive up to an aggregate of $20.0 million, less required income, withholding and other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in the United States, China and Korea. In the event that VGX-3100 is approved for marketing, we will be entitled to receive royalty payments based on a tiered percentage of annual net sales, with such percentage being in the low- to mid-teens, subject to reduction in the event of generic competition in a particular territory. ApolloBio’s obligation to pay royalties will continue for 10 years after the first commercial sale in a particular territory or, if later, until the expiration of the last-to-expire patent covering the licensed products in the specified territory.
Our corporate strategy is to advance, protect and protectexploit our differentiated immunotherapy platform andplatform. Through the use itsof our unique capabilities toon both design and developdevelopment, we continue to progress and validate an array of HPV related diseases, as well as cancer and infectious disease immunotherapy and vaccine products. We aim to advance products through to commercialization. Wecommercialization and continue to leverage third-party resources through collaborations and partnerships, including product license agreements. Our partners and collaborators include MedImmune, LLC, The Wistar Institute, University of Pennsylvania,AstraZeneca, Regeneron Pharmaceuticals, Inc., F. Hoffmann-La Roche AG/Genentech, Inc., ApolloBio Corporation, GeneOne Life Science Inc. (GeneOne), ApolloBio, Regeneron Pharmaceuticals, Inc.The Bill and Melinda Gates Foundation, The Parker Institute for Cancer Immunotherapy (PICI), Genentech, Inc.Coalition for Epidemic Preparedness Innovations (CEPI), Plumbline Life Sciences, Inc., Drexel University, National Institute of Allergy and Infectious Diseases, or NIAID, United States Military HIV Research Program, U.S. Army Medical Research Institute of Infectious Diseases, National Institutes of Health, HIV Vaccines Trial Network, Defense Advanced Research Projects Agency or DARPA, Parker(DARPA), National Institutes of Health (NIH), HIV Vaccines Trial Network (HVTN), National Cancer Institute for Cancer Immunotherapy,(NCI), Walter Reed Army Institute of Research, Medical CBRN Defense Consortium (MCDC),The Wistar Institute and CEPI.the University of Pennsylvania.

In August 2016,February 2019, we incorporatedcompleted a spin-out of our previously wholly-owned subsidiary GENEOSGeneos Therapeutics, Inc., or GENEOS, to develop and commercialize neoantigen based personalized cancer therapies. While we leverage our SynCon immunotherapy and CELLECTRA® electroporation technologies to break tolerance and create cancer products targeting shared tumor specific antigens, GENEOS is focusing on leveraging our immunotherapy technology platform to advanceGeneos. In connection with the fieldspin-out, Geneos completed the initial closing of patient-specific neoantigen therapies for cancer.a preferred stock financing with outside investors. We believe that our clinically validated DNA-based platform is well suited for advancing individualized therapies due to its rapid product design and manufacturing benefits, ability to combine multiple neoantigens into formulations, and generation of potent killer T cell responses that are needed to drive clinical efficacy. We have exclusively licensed our SynCon immunotherapy and CELLECTRA® electroporation technology platform to GENEOS to be usedinvested $1.2 million in the fieldpreferred stock financing, which was led by an outside investor. The terms of personalized, neoantigen-based therapythe stock purchase agreement include commitments for cancer. We currently own 100%additional investments by us of $800,000 and by the other investors upon the occurrence of a specified regulatory event, as well as an option for us to purchase $800,000 of additional preferred stock of Geneos upon the achievement of a specified milestone. Following the initial closing of the financing transaction, we continue to hold a majority of the outstanding equity, on an as-converted to common stock basis, of GENEOS, although GENEOS currently plans to raise capital from the issuance of equity. This capital may be provided by third parties, which would reduce ourGeneos. Our ownership percentage although we may also provideof Geneos would decrease in the event of additional equity funding to GENEOS.purchases of preferred stock of Geneos by the other investors under the terms of the stock purchase agreement.
All of our product candidates are in the research and development phase. We have not generated any revenues from the sale of any products, and we do not expect to generate any such revenues for at least the next several years. We earn revenue from license fees and milestone revenue and collaborative research and development agreements. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.
Recent Developments
Sale of Convertible Bonds
On August 1, 2019, we closed a private placement of 1.0% convertible bonds due 2024 with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm based in Seoul, Korea. We also announced our intent to pursue a listing of our securities on the KOSDAQ Market of the Korea Exchange (KOSDAQ) in the form of Korean Depositary Receipts (KDRs) representing shares of common stock.
The bonds, which are our unsecured obligations, were issued on August 1, 2019 and will accrue interest at a coupon rate of 1.00% per annum, payable quarterly. The bonds will mature on July 31, 2024, unless earlier converted or repurchased. The outstanding bonds will be repaid at maturity at a price equal to the principal of the outstanding bonds to be repaid plus a premium on such bonds to provide an internal rate of return with respect to such bonds of 6.00%. Commencing on August 1, 2020, the bonds will be convertible until the date that is one month prior to maturity date. Upon conversion, we will deliver KDRs, if any such securities are listed on the KOSDAQ at that time, or otherwise shares of common stock, if KDRs are not listed on KOSDAQ at that time or the converting holder requests delivery of shares of common stock. The initial conversion rate will be 211.0595 shares per KRW1,000,000 principal amount of bonds (equivalent to an initial conversion price of approximately USD $4.00 per share based on the exchange rate as of July 30, 2019), subject to adjustment upon the occurrence of specified events. The conversion rate is subject to reset on January 2, 2020 and on each three month anniversary thereafter until the maturity date to the then current market price if the current market price is lower than the conversion price then in effect; provided that the conversion rate will not exceed 351.7658 shares per KRW1,000,000 (equivalent to a conversion price of approximately USD $2.40 per share based on the exchange rates as of July 30, 2019).
The bonds will be subject to repurchase by us at the option of the bondholders from and including July 31, 2022 up to the date that is one month prior to the maturity date at a repurchase price equal to the principal of the bonds to be repurchased plus a premium on the bonds in order to provide an internal rate of return with respect to the bonds of 6.00%. In addition, upon the occurrence of a fundamental change (as defined in the bonds), we will be required to offer to repurchase the bonds at a repurchase price equal to the principal amount thereof plus accrued and unpaid interest thereon to but excluding the applicable repurchase date.

Planned Cost Reductions
In July 2019, we announced a strategic organizational restructuring. In order to reduce operating expenses and conserve cash resources, we also announced a reduction of approximately 28% of our workforce and the discontinuation of our immuno-oncology Phase 1/2 clinical trial of our product candidate INO-5401 in patients with advanced bladder cancer. We expect to incur a personnel-related restructuring charge of approximately $2.3 million in connection with one-time employee termination costs, including severance and other benefits, which is expected to be incurred primarily in the third quarter of 2019.
Phase 2 Prostate Cancer Combination Trial in Collaboration with PICI
In January 2018, we announced that we and PICI had entered into a clinical collaboration agreement that provides for us and PICI to undertake clinical evaluation of novel combination regimens within the field of immuno-oncology. In July 2019, we announced that, as part of this collaboration, our cancer immunotherapy product candidate, INO-5151, will be combined with an immune modulator, CDX-301, and a PD-1 checkpoint inhibitor, nivolumab, in an open-label, non-randomized, exploratory Phase 2 clinical trial evaluating the safety and efficacy of the combination as a potential treatment for metastatic castration resistant prostate cancer. INO-5151 is a combined formulation of our product candidates INO-5150, with SynCon® antigens encoding for PSA and PSMA, and INO-9012 (DNA vector expressing interleukin 12). Our immunotherapy is one arm of a broader, multi-arm, multi-stage trial being conducted and funded by PICI. We would provide financial contributions if our product candidate reaches the initiation of a Phase 3 clinical trial.

Critical Accounting Policies
There have been no significant changes to our critical accounting policies since December 31, 2017,2018, other than our adoption of ASU No. 2014-09,2016-02, Revenue from Contracts with CustomersLeases, or Topic 606, and ASU 2018-07, Compensation—Stock Compensation, as of January 1, 2018. Topic 606 amended the existing accounting standards for revenue recognition. We also adopted ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which amended the accounting standards for the measurement of some kinds of equity investments.2019. For a description of newly adopted critical accounting policies, see Note 3 to our Condensed Consolidated Financial Statements included in this Quarterly Report. For a description of our other critical accounting policies that affect our significant judgments and estimates used in the preparation of our condensed consolidated financial statements, refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 20172018 Annual Report and Note 2 to our audited Consolidated Financial Statements contained in our 20172018 Annual Report.

Adoption of Recent Accounting Pronouncements
Information regarding recent accounting pronouncements is contained in Note 4 to the Condensed Consolidated Financial Statements, included in this Quarterly Report.

Results of Operations
Revenue. We had total revenue of $136,000 and $3.0 million for the three and six months ended June 30, 2019, respectively, as compared to $24.4 million and $26.0 million for the three and six months ended June 30, 2018, respectively, as compared to $20.4 million and $30.8 million for the three and six months ended June 30, 2017, respectively. Revenue primarily consisted of revenue under collaborative research and development arrangements for the three and six months ended June 30, 2018, and revenue under collaborative research and development arrangements, grants and government contracts for the three and six months ended June 30, 2017.
As of January 1, 2018, accounting for our various grant agreements falls under the contributions guidance under Subtopic 958-605, Not-for-Profit Entities-Revenue Recognition, which is outside the scope of Topic 606, as the government agencies granting us funds are not receiving reciprocal value for their contributions. Beginning on January 1, 2018, all contributions received from current grant agreements are being recorded as a contra-expense as opposed to revenue on the condensed consolidated statement of operations. For the three and six months ended June 30, 2018, $1.9 million and $4.1 million, respectively, would have been recorded as grant revenue but under the new guidance was instead recorded as a reduction to research and development expense. See Note 4 to the Condensed Consolidated Financial Statements included in this Quarterly Report for further discussion.
Revenuerevenues under collaborative research and development arrangements, including arrangements with affiliated entities, was $24.4 million and $25.9 million for each of the three and six months ended June 30, 2018, respectively, as compared to $16.5 million2019 and $21.1 million for the three and six months ended June 30, 2017, respectively.2018. The increasesyear over year decreases were primarily due to the recognition of the grossa one-time up-front payment of $23.0 million from our collaborator ApolloBio during the second quarter 2018. These increases were offset by decreases in revenues from the MedImmune collaboration of $12.8 million and $11.8 million for the three- and six-month periods, respectively, as previously deferred revenue was recognized during the three months ended June 30, 2017, upon selection of the first cancer research collaboration product candidate by MedImmune. There was also no revenue

recognized in 2018 from our Roche collaboration compared to $2.1 million and $6.1 million for the three and six months ended June 30, 2017, due to the termination of the agreement in 2017.
During the three and six months ended June 30, 2018, grant funding received and recorded as contra-research and development expense was $1.9 million and $4.1 million, respectively, as compared to $3.9 million and $9.7 million recorded as grant and miscellaneous revenue, including arrangements with affiliated entities, for the three and six months ended June 30, 2017, respectively. The decrease in grant funding recorded for the three-month period year over year was primarily due to decreases from our DARPA Ebola grant and Zika virus sub-grant of $2.2 million and $681,000, respectively, partially offset by an increase from our CEPI grant of $834,000. The decrease in grant funding recorded for the six-month period year over year was primarily due to a decrease from our DARPA Ebola grant of $6.9 million, partially offset by increases from our CEPI grant and Zika virus sub-grant of $834,000 and $504,000, respectively.2018.
Research and development expenses. Research and development expenses for the three and six months ended June 30, 20182019 were $22.5 million and $47.0$46.9 million, respectively, as compared to $23.9$22.5 million and $48.4$47.0 million for the three and six months ended June 30, 2017,2018, respectively. Total research and development expenses were consistent between the three months ended June 30, 2018 and 2019; however, fluctuations included a decrease in employee compensation expense of $1.8 million and a decrease in research and development pre-clinical expenses of $736,000, offset by an increase in employee and consultant stock-based compensation of $1.0 million, an increase in clinical trial related expenses of $836,000 and an increase in allocated expenses, including facilities, information technology (IT) and depreciation expense of $362,000, among other variances. Fluctuations between the six months ended June 30, 2018 and 2019 included a $2.4 million increase in contra-research and development expense recorded from grant agreements, as well as no sub-license fee expense in 2019 as compared to $1.9 million recorded in 2018 related to the ApolloBio collaboration and lower employee compensation expense of $804,000, offset by an increase in clinical trial related expenses of $3.0 million, higher stock-based compensation expense of $951,000 and an increase in allocated expenses of $819,000, among other variances.
Contributions received from current grant agreements and recorded as contra-research and development expense were $2.6 million and $6.5 million for the three and six months ended June 30, 2019, respectively, as compared to $1.9 million and $4.1 million for the three and six months ended June 30, 2018, respectively. The decreaseincrease for the three-month period year over year was primarily due to the $1.9 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.1 million in expenses related to the DARPA Ebola grant. These decreases were partially offset by an increase of $1.3 million related to increased employee headcount to support clinical trials and partnerships, an increase of $698,000 earned from the Bill & Melinda Gates Foundation grant related to clinical study expenses and drug manufacturing for our VGX-3100 clinical trialsdMAb technology and an increase of $690,000 for drug manufacturing related to$635,000 under our collaboration with MedImmune,CEPI grant, which increase was offset in part by a decrease of $496,000

under our DARPA Ebola grant, among other variances. The decreaseincrease for the six-month period year over year was primarily due to the $4.1 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $4.3 million in expenses related to the DARPA Ebola grant. These decreases were partially offset by an increase of $2.6$2.3 million related to clinical study expenses and drug manufacturing for our VGX-3100 clinical trials, an increase of $2.4 million related to increased employee headcount to support clinical trials and partnershipsearned from the CEPI grant and an increase of $1.8 million for drug manufacturingfrom the Bill & Melinda Gates Foundation grant, offset in part by decreases of $1.2 million and $776,000 from the Wistar sub-grant related to our collaboration with MedImmune,Zika and the DARPA Ebola grant, respectively, among other variances.
General and administrative expenses. General and administrative expenses, which include business development expenses, the amortization of intangible assets and patent expenses, were $5.9 million and $12.8 million for the three and six months ended June 30, 2019, respectively, as compared to $7.2 million and $16.9 million for the three and six months ended June 30, 2018, respectively, as compared to $6.2 million and $13.9 million for the three and six months ended June 30, 2017, respectively. The increasedecrease for the three-month period year over year was primarily related to increases in personnel costs from increases inlower employee headcount, legal expense, depreciation expense and rent expense of $420,000, $416,000, $276,000 and $256,000, respectively, partially offset by a decrease in non-cash stock-based compensation expense of $196,000,$618,000 and lower depreciation expense of $449,000, among other variances. The increasedecrease for the six-month period year over year was primarily related to the $1.4 million of foreign non-income taxes withheld from the ApolloBio upfront payment we received in Marchthe first quarter of 2018 and the associated advisory fees of $960,000 incurred in connection with receiving$960,000. The decrease was also the upfront payment. There were also increases in personnel costs from increases in employee headcount, legal expense,result of lower depreciation expense of $833,000 and rent expenselower expenses related to employee compensation, recruitment and contract labor of $644,000, $588,000, $557,000$252,000, $230,000 and $490,000,$227,000, respectively, partially offset by a decrease in non-cash stock-based compensation expense of $1.9 million, among other variances.
Stock-based compensation. Stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense for the three and six months ended June 30, 20182019 was $2.4$3.1 million and $5.8$6.3 million, respectively. Of these amounts, $1.4$2.3 million and $3.5$4.2 million, respectively, werewas included in research and development expenses, and $1.0 million$877,000 and $2.3$2.1 million, respectively, werewas included in general and administrative expenses. Total employee and director stock-based compensation expense for the three and six months ended June 30, 20172018 was $2.4 million and $7.7$5.8 million, respectively. Of these amounts, $1.2$1.4 million and $3.5 million, respectively, werewas included in research and development expenses, and $1.2$1.0 million and $4.2$2.3 million, respectively, werewas included in general and administrative expenses. The decrease for the six-month period year over year wasincreases were primarily due to an option modification expense recorded in the second quarter of 2019, offset in part by a lower weighted average grant date fair value per share for the awards granted in 2018.2019.
Interest and other income, net.income. Interest and other income net, for the three and six months ended June 30, 20182019 was $397,000$755,000 and $709,000,$1.4 million, respectively, as compared to $300,000$519,000 and $640,000,$1.1 million, respectively, for the three and six months ended June 30, 2017.2018. The increases were related to the interest earned on our short-term investments.
Interest expense. Interest expense for the three and six months ended June 30, 2019 was $2.2 million and $2.9 million, respectively, compared to $0 in prior year periods. The interest expense relates to our 6.5% convertible senior notes due 2024, or the Notes, which were issued during the first quarter of 2019.
Change in fair value of common stock warrants. The change in fair value of common stock warrants we issued in March 2013 for the three and six months ended June 30, 2018 were decreases ofwas $260,000 and $132,000, respectively, as compared to increases of $313,000 and $196,000, respectively forrespectively. The warrants were exercised during the three and six monthsquarter ended JuneSeptember 30, 2017. The variance is due to2018, eliminating the revaluation of the warrants at each balance sheet date to theirassociated fair value. If unexercised, the remaining warrants will expirevalue re-measurement in September 2018.subsequent periods.
Gain (loss) on investment in affiliated entities. The gain (loss) results from the change in the fair market value of the investments in GeneOne and PLS for a loss of $(2.1) million$(173,000) and a gain of $288,000$(923,000), respectively, for the three and six months ended June 30, 2018, respectively,2019 as compared to a loss of $(2.1) million and a gain of $169,000 and a loss of $(1.4) million,$288,000, respectively, from GeneOne for the three

and six months ended June 30, 2017. After2018. We record our investments in GeneOne and PLS at their market values based on the adoptionclosing prices of ASU No. 2016-01those securities on January 1, 2018, unrealized gains and losses on PLS are recorded onthe applicable stock exchange at each balance sheet date, with changes in fair value reflected in the condensed consolidated statementstatements of operations.
Income tax benefit/(Provision for income taxes). The income tax benefit of $107,000 and $170,000 recorded for the three and six months ended June 30, 2019, respectively, reflected our application of the intraperiod tax allocation rules under which we are required to record a tax benefit in continuing operations as a gain (loss) on investment in affiliated entities rather thanto offset the condensed consolidated statement oftax provision we recorded directly to other comprehensive income (loss).
Provision for income taxes. related to unrealized gains on our short-term investments. The provision for income taxes of $2.2 million for the six months ended June 30, 2018 was related to foreign income taxes on the upfront payment received from ApolloBio in March 2018.

Liquidity and Capital Resources
Historically, our primary uses of cash have been to finance research and development activities including clinical trial activities in the oncology, DNA vaccines and other immunotherapy areas of our business. Since inception, we have satisfied our cash requirements principally from proceeds from the sale of equity securities.securities and grants and government contracts.

Working Capital and Liquidity
As of June 30, 2018,2019, we had cash and short-term investments of $95.6$106.0 million and working capital of $73.4$86.4 million, as compared to $127.4$81.2 million and $103.0$52.5 million, respectively, as of December 31, 2017.2018. The decreaseincrease in cash and short-term investments during the six months ended June 30, 20182019 was primarily due to the net proceeds of $75.7 million received from

the issuance of our Notes, offset by expenditures related to our research and development activities, clinical trials and various general and administrative expenses related to legal, consultants, accounting and audit, and corporate development, partially offset by thedevelopment.
In August 2019, we received an additional $15.0 million in net proceeds received from ApolloBiothe sale of $19.4 million, as well as sales of common stock under our at-the-market, or ATM, sales agreements of $2.0 million.1.0% convertible bonds due 2024 to institutional investors led by KIP.

Cash Flows
Net cash used in operating activities was $31.6$56.4 million and $31.9$31.6 million for the six months ended June 30, 20182019 and 2017,2018, respectively. Net cash used in operating activities for the six months ended June 30, 2019 consisted of net loss of $58.9 million, less changes in net operating assets and liabilities of $10.5 million partially offset by net non-cash adjustments of $12.9 million. The primary non-cash expenses added back to net loss included stock-based compensation of $6.8 million, interest expense of $2.9 million and depreciation and amortization of $2.4 million.
Net cash used in operating activities for the six months ended June 30, 2018 consisted of net loss of $39.0 million, plusless changes in net operating assets and liabilities of $(1.2)$1.4 million, partially offset by net non-cash adjustments of $8.6$8.7 million. The primary non-cash expenses added back to net loss included stock-based compensation of $6.2 million and depreciation and amortization of $2.6 million.
Net cash used in operating activities for the six months ended June 30, 2017 consisted of net loss of $32.6 million, plus changes in net operating assets and liabilities of $(12.9) million, partially offset by net non-cash adjustments of $13.5 million. The primary non-cash expenses added back to net loss included stock-based compensation of $7.9 million, depreciation and amortization of $1.8 million and loss on investment in affiliated entity of $1.4 million.
Net cash(used in) provided by investing activities was $20.8$(27.7) million and $11.7$20.8 million for the six months ended June 30, 20182019 and 2017,2018, respectively. The variance was primarily the result of timing differences in short-term investment purchases, sales and maturities.
Net cash provided by financing activities was $2.1$80.2 million and $24.9$2.1 million for the six months ended June 30, 20182019 and 2017,2018, respectively. The variance was primarily due to lessthe net proceeds received from our issuance of the Notes as well as the acquisition of a non-controlling interest in Geneos, both of which occurred in 2019.
In the first quarter of 2019, we completed a private placement of $78.5 million aggregate principal amount of Notes, sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the sale of common stock under our ATM sales agreements duringoffering were approximately $75.7 million, after deducting the 2018 period.initial purchasers' discount and offering expenses payable by us. See Note 9 to the Condensed Consolidated Financial Statements included in this Quarterly Report for further discussion.
In May 2018, we entered into an At-the-Market Equity Offering Sales Agreement, , or the Sales Agreement, with an outside placement agent, or the Placement Agent, to sell shares of our common stock with aggregate gross proceeds of up to $100.0 million, from time to time, through an “at-the-market” equity offering program under which the Placement Agent will act as sales agent. During the six months ended June 30, 2018,2019, we sold 92,479659,800 shares of common stock under the Sales Agreement for aggregate net proceeds of $410,000.
During the six months ended June 30, 2018, we sold a total of 314,950 shares of common stock for net proceeds of $1.6 million under our previous At-the-Market Equity Offering Sales Agreement, or the Prior Sales Agreement, which we entered into in June 2016 with the same Placement Agent. The registration statement that registered with the SEC the shares sold under the Prior Sales Agreement expired in June 2018, and no further sales may be made under the Prior Sales Agreement. During the six months ended June 30, 2017, we sold 2,917,725 shares of common stock under the Prior Sales Agreement for aggregate net proceeds of $24.1 million.
During the six months ended June 30, 2018, stock options to purchase 281,959 shares of common stock were exercised for aggregate net proceeds of $690,000. During the six months ended June 30, 2017, stock options to purchase 329,259 shares of common stock were exercised for aggregate net proceeds of $1.7$2.3 million.
As of June 30, 2018,2019, we had an accumulated deficit of $562.1$679.0 million. We have operated at a loss since 1994 and we expect to continue to operate at a loss for some time. The amount of the accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. If these activities are successful and if we receive approval from the FDA to market our DNA vaccine products, then we will need to raise additional funding to market and sell the approved vaccine products and equipment. We cannot predict the outcome of the above matters at this time. We are evaluating potential

collaborations as an additional way to fund operations. We believe that our current cash and short-term investments are sufficient to meet planned working capital requirements for at least the next twelve months from the date this Quarterly Report is filed.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

ITEM 3.    QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
Market risk represents the risk of loss that may impact our consolidated financial position, results of operations or cash flows due to adverse changes in financial and commodity market prices and rates. We are exposed to market risk primarily in the area of changes in United States interest rates and conditions in the credit markets, and the recent fluctuations in interest rates and availability of funding in the credit markets primarily impact the performance of our investments. We do not have any material foreign currency or other derivative financial instruments. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We attempt to increase the safety and preservation of our invested principal funds by limiting default risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade securities. Due to the short-term maturities of our cash equivalents and the low risk profile of our

investments at June 30, 2018,2019, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents.
The interest rate on our indebtedness, consisting exclusively of the Notes, is fixed and not subject to fluctuations in interest rates.

Fair Value Measurements
We account for our common stock warrants pursuant to the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company's own stock, on the understanding that in compliance with applicable securities laws, the registered warrants require the issuance of registered securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. We classify registered warrants on the consolidated balance sheet as a current liability that is revalued at each balance sheet date subsequent to the initial issuance.
The investment in affiliated entities represents our ownership interest in the Korean-based companies, GeneOne and PLS. We report these investments at fair value on the condensed consolidated balance sheet using the closing price of GeneOne and PLS shares of common stock as reported on the date of determination on the Korean Stock Exchange and Korea New Exchange Market, respectively.
Foreign Currency Risk
We have operated primarily in the United States and most transactions during the six months ended June 30, 20182019 were made in United States dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations, with the exception of the valuation of our equity investments in GeneOne and PLS which are denominated in South Korean Won and then translated into United States dollars. We do not have any foreign currency hedging instruments in place.
Certain transactions related to us are denominated primarily in foreign currencies, including Euros, British Pounds, Canadian Dollars and South Korean Won. As a result, our financial results could be affected by factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets where we conduct business.
We do not use derivative financial instruments for speculative purposes. We do not engage in exchange rate hedging or hold or issue foreign exchange contracts for trading purposes. Currently, we do not expect the impact of fluctuations in the relative fair value of other currencies to be material in 2018.2019.
 
ITEM 4.    CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, as appropriate to allow timely decisions regarding required disclosures.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our

management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Based on an evaluation carried out as of the end of the period covered by this Quarterly Report, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) were effective as of June 30, 20182019 at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There have not been any changes in our internal control over financial reporting that occurred during the quarter ended June 30, 20182019 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


Part II. Other Information
 
ITEM 1.    LEGAL PROCEEDINGS
We are not currently a party to any material litigation or other material legal proceedings.
 
ITEM 1A.    RISK FACTORS
Our business is subject to numerous risks. You should carefully consider and evaluate each of the following factors as well as the other information in this Quarterly Report on Form 10-Q, including our financial statements and the related notes, the risk factors discussed in our 20172018 Annual Report, which we filed with the SEC on March 14, 2018,12, 2019, in evaluating our business and prospects. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business operations. If any of the following risks actually occur, our business and financial results could be harmed. In that case, the trading price of our common stock could decline. You should also consider the more detailed description of our business contained in our 20172018 Annual Report.
Risks Related to Our Business and Industry
We have incurred losses since inception, expect to incur significant net losses in the foreseeable future and may never become profitable.
We have experienced significant operating losses to date; as of June 30, 20182019, our accumulated deficit was approximately $562.1679.0 million. We have generated limited revenues, primarily consisting of license revenue, grant funding and interest income. We expect to continue to incur substantial additional operating losses for at least the next several years as we advance our clinical trials and research and development activities. We may never successfully commercialize our vaccine product candidates or electroporation-based synthetic vaccine delivery technology and thus may never have any significant future revenues or achieve and sustain profitability.
We have limited sources of revenue and our success is dependent on our ability to develop our vaccine and immunotherapies and other product candidates and electroporation equipment.
We do not sell any products and may not have any other products commercially available for several years, if at all. Our ability to generate future revenues depends heavily on our success in:
developing and securing United States and/or foreign regulatory approvals for our product candidates, including securing regulatory approval for conducting clinical trials with product candidates;
developing our electroporation-based DNA delivery technology; and
commercializing any products for which we receive approval from the FDA and foreign regulatory authorities.
Our electroporation equipment and product candidates will require extensive additional clinical study and evaluation, regulatory approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote our electroporation equipment and product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities. If we do not receive regulatory approval for and successfully commercialize any products, we will not generate any revenues from sales of electroporation equipment and products, and we may not be able to continue our operations.
None of our human vaccine and immunotherapy product candidates have been approved for sale, and we may not develop commercially successful vaccine products.
Our human vaccine and immunotherapy programs are in the early stages of research and development, and currently include vaccine product candidates in discovery, preclinical studies and Phase 1, 2 and 3 clinical trials. There are limited data regarding the efficiencyefficacy of synthetic vaccine and immunotherapy candidates compared with conventional vaccines, and we must conduct a substantial amount of additional research and development before any regulatory authority will approve any of our vaccine product candidates. The success of our efforts to develop and commercialize our product candidates could fail for a number of reasons. For example, we could experience delays in product development and clinical trials. Our product candidates could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances. The products, if safe and effective, could be difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their competing products.
In addition, adverse events, or the perception of adverse events, relating to vaccine and immunotherapy candidates and delivery technologies may negatively impact our ability to develop commercially successful products. For example,

pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism. These and other claims may influence public perception of the use of vaccine and immunotherapy products and could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential products.
Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations.
We recently sold $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024, or the Notes, as well as $15.0 million aggregate principal amount of 1.0% convertible bonds due 2024, or the Korean Bonds. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
increasing our vulnerability to adverse economic and industry conditions;
limiting our ability to obtain additional financing;
requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for other purposes;
limiting our flexibility to plan for, or react to, changes in our business;
diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Notes and the Korean Bonds; and
placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital.
Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under the Notes and the Korean Bonds and any additional indebtedness that we may incur. In addition, our cash needs may increase in the future. In addition, any future indebtedness that we may incur may contain financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately payable in full.
The conditional conversion features of the Notes, if triggered, may adversely affect our financial condition, operating results, or liquidity.
In the event the conditional conversion feature of the Notes is triggered, holders of the Notes will be entitled to convert their Notes into shares of our common stock at any time during specified periods at their option. If one or more of the holders of the Notes elects to convert their Notes, unless we satisfy our conversion obligation by delivering only shares of our common stock, we would be required to settle all or a portion of our conversion obligation through the payment of cash, which could adversely affect our liquidity. The conditional convertibility of the Notes will be monitored at each quarterly reporting date and analyzed dependent upon market prices of our common stock during the prescribed measurement periods.
Conversion of the Notes and/or the Korean Bonds will dilute the ownership interest of existing stockholders, including holders who had previously converted their Notes or Korean Bonds, or may otherwise depress the price of our common stock.
The conversion of some or all of the Notes and/or Korean Bonds will dilute the ownership interests of existing stockholders to the extent we deliver shares of our common stock upon conversion of any of the Notes. The Notes may become in the future convertible at the option of the holders of the Notes prior to November 1, 2023 under certain circumstances as provided in the indenture governing the Notes. The Korean Bonds may become in the future convertible at the option of the holders of the Korean Bonds starting August 1, 2020 until the date that is one month prior to maturity date of the Korean Bonds. Any sales in the public market of the common stock issuable upon such conversion could adversely affect prevailing market prices of our common stock. In addition, the existence of the Notes may encourage short selling by market participants because the conversion of the Notes could be used to satisfy short positions, or anticipated conversion of the Notes into shares of our common stock could depress the price of our common stock.
We may not have the ability to raise the funds necessary to settle conversions of the Notes in cash, to repurchase the Notes or the Korean Bonds upon a fundamental change or to repurchase the Korean Bonds from and including July 31, 2022 up to the date falling one month prior to the maturity date of the Korean Bonds, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Notes.
Subject to certain conditions, holders of the Notes or the Korean Bonds may require us to repurchase for cash all or a portion of their Notes or Korean Bonds, respectively, upon the occurrence of a fundamental change (as defined in the indenture governing the Notes or the Korean Bonds, respectively) at a repurchase price equal to 100% of the principal amount of the

Notes or Korean Bonds, as applicable, to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. In addition, if a make-whole fundamental change (as defined in the indenture for the Notes) occurs prior to the maturity date of the Notes, we will in some cases be required to increase the conversion rate for a holder that elects to convert its Notes in connection with such make-whole fundamental change. The Korean Bonds will be subject to repurchase by us at the option of the holders thereof from and including July 31, 2022 up to the date falling one month prior to the maturity date at a repurchase price equal to the principal of the Korean Bonds to be repurchased plus a premium on such Korean Bonds in order to provide an internal rate of return with respect to such Korean Bonds of 6.00%. Upon a conversion of the Notes, unless we elect to deliver solely shares of our common stock to settle such conversion (other than paying cash in lieu of delivering any fractional share), we will be required to make cash payments in respect of the Notes being converted. However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of Notes or Korean Bonds surrendered for repurchase or pay cash with respect to Notes being converted.
In addition, our ability to repurchase or to pay cash upon conversion of the Notes may be limited by law, regulatory authority or agreements governing our future indebtedness. Our failure to repurchase the Notes at a time when the repurchase is required by the indenture governing the Notes or to pay cash upon conversion of the Notes as required by the indenture would constitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under our Korean Bonds or agreements governing our future indebtedness. If the payment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or the Korean Bonds or to pay cash upon conversion of the Notes.
We will need substantial additional capital to develop our synthetic vaccine and immunotherapy programs and electroporation delivery technology.
Conducting the costly and time consumingtime-consuming research, pre-clinical and clinical testing necessary to obtain regulatory approvals and bring our product candidates and delivery technology to market will require a commitment of substantial funds in excess of our current capital. Our future capital requirements will depend on many factors, including, among others:
the progress of our current and new product development programs;
the progress, scope and results of our pre-clinical and clinical testing;
the time and cost involved in obtaining regulatory approvals;
the cost of manufacturing our products and product candidates;
the cost of prosecuting, enforcing and defending against patent infringement claims and other intellectual property rights;
debt service obligations on the Notes and Korean Bonds;
competing technological and market developments; and
our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market.
Additional financing may not be available on acceptable terms, or at all. Domestic and international capital markets have from time to time experienced heightened volatility and turmoil, making it more difficult to raise capital through the issuance of equity securities. Volatility in the capital markets can also negatively impact the cost and availability of credit, creating illiquid credit markets and wider credit spreads. Concern about the stability of the markets generally and the strength of counterparties specifically has led many lenders and institutional investors to reduce, and in some cases cease to provide, funding to borrowers. To the extent we are able to raise additional capital through the sale of equity securities or we issue securities in connection with another transaction, the ownership position of existing stockholders could be substantially diluted. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets. Fluctuating interest rates could also increase the costs of any debt financing we may obtain. Raising capital through a licensing or other transaction involving our intellectual property could require us to relinquish valuable intellectual property rights and thereby sacrifice long-term value for short-term liquidity.
Our failure to successfully address ongoing liquidity requirements would have a substantially negative impact on our business. If we are unable to obtain additional capital on acceptable terms when needed, we may need to take actions that adversely affect our business, our stock price and our ability to achieve cash flow in the future, including possibly surrendering our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

We depend upon key personnel who may terminate their employment with us at any time and we may need to hire additional qualified personnel in order to obtain financing, pursue collaborations or develop or market our product candidates.
The success of our business strategy will depend to a significant degree upon the continued services of key management, technical and scientific personnel and our ability to attract and retain additional qualified personnel and managers, including personnel with expertise in clinical trials, government regulation, manufacturing, marketing and other areas. Competition for qualified personnel is intense among companies, academic institutions and other organizations. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.
We face intense and increasing competition and many of our competitors have significantly greater resources and experience.
If any of our competitors develop products with efficacy or safety profiles significantly better than our products, we may not be able to commercialize our products, and sales of any of our commercialized products could be harmed. Some of our competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do. Competitors may develop products earlier, obtain FDA approvals for products more rapidly, or develop products that are more effective than those under development by us. We will seek to expand our

technological capabilities to remain competitive; however, research and development by others may render our technologies or products obsolete or noncompetitive, or result in treatments or cures superior to ours.
Many other companies are pursuing other forms of treatment or prevention for diseases that we target. For example, many of our competitors are working on developing and testing cancer vaccines and immunotherapies and several products such as the CAR-Ts developed by our competitors have been approved for human use. Our competitors and potential competitors include large pharmaceutical and more established biotechnology companies. These companies have significantly greater financial and other resources and greater expertise than us in research and development, securing government contracts and grants to support research and development efforts, manufacturing, pre-clinical and clinical testing, obtaining regulatory approvals and marketing. This may make it easier for them to respond more quickly than us to new or changing opportunities, technologies or market needs. Many of these competitors operate large, well-funded research and development programs and have significant products approved or in development. Small companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical companies or through acquisition or development of intellectual property rights. Our potential competitors also include academic institutions, governmental agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for product and clinical development and marketing. Research and development by others may seek to render our technologies or products obsolete or noncompetitive.
If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.
We have entered into, or may enter into, distribution, co-promotion, partnership, sponsored research and other arrangements for development, manufacturing, sales, marketing and other commercialization activities relating to our products. For example, in the past we have entered into license and collaboration agreements. The amount and timing of resources applied by our collaborators are largely outside of our control.
If any of our current or future collaborators breaches or terminates our agreements, or fails to conduct our collaborative activities in a timely manner, our commercialization of products could be diminished or blocked completely. We may not receive any event-based payments, milestone payments or royalty payments under our collaborative agreements if our collaborative partners fail to develop products in a timely manner or at all. It is possible that collaborators will change their strategic focus, pursue alternative technologies or develop alternative products, either on their own or in collaboration with others. Further, we may be forced to fund programs that were previously funded by our collaborators, and we may not have, or be able to access, the necessary funding. The effectiveness of our partners, if any, in marketing our products will also affect our revenues and earnings.
We desire to enter into new collaborative agreements. However, we may not be able to successfully negotiate any additional collaborative arrangements and, if established, these relationships may not be scientifically or commercially successful. Our success in the future depends in part on our ability to enter into agreements with other highly-regarded organizations. This can be difficult due to internal and external constraints placed on these organizations. Some organizations may have insufficient administrative and related infrastructure to enable collaborations with many companies at once, which can extend the time it takes to develop, negotiate and implement a collaboration. Once news of discussions regarding possible collaborations are known in the medical community, regardless of whether the news is accurate, failure to announce a collaborative agreement or the entity's announcement of a collaboration with another entity may result in adverse speculation about us, resulting in harm to our reputation and our business.

Disputes could also arise between us and our existing or future collaborators, as to a variety of matters, including financial and intellectual property matters or other obligations under our agreements. These disputes could be both expensive and time-consuming and may result in delays in the development and commercialization of our products or could damage our relationship with a collaborator.
A small number of licensing partners and government contracts account for a substantial portion of our revenue.
We currently derive, and in the past we have derived, a significant portion of our revenue from a limited number of licensing partners and government grants and contracts. Revenue can fluctuate significantly depending on the timing of up-frontupfront and event-based payments and work performed. If we fail to sign additional future contracts with major licensing partners and the government, if a contract is delayed or deferred, or if an existing contract expires or is canceled and we fail to replace the contract with new business, our revenue would be adversely affected.
We have agreements with government agencies, which are subject to termination and uncertain future funding.
We have entered into agreements with government agencies, such as the NIAID and DARPA, and we intend to continue entering into these agreements in the future. Our business is partially dependent on the continued performance by these

government agencies of their responsibilities under these agreements, including adequate continued funding of the agencies and their programs. We have no control over the resources and funding that government agencies may devote to these agreements, which may be subject to annual renewal and which generally may be terminated by the government agencies at any time.
Government agencies may fail to perform their responsibilities under these agreements, which may cause them to be terminated by the government agencies. In addition, we may fail to perform our responsibilities under these agreements. Many of our government agreements are subject to audits, which may occur several years after the period to which the audit relates. If an audit identifies significant unallowable costs, we could incur a material charge to our earnings or reduction in our cash position. As a result, we may be unsuccessful entering, or ineligible to enter, into future government agreements.
Our quarterly operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including:
variations in the level of expenses related to our electroporation equipment, product candidates or future development programs;
expenses related to corporate transactions, including ones not fully completed;
addition or termination of clinical trials or funding support;
any intellectual property infringement lawsuit in which we may become involved;
any legal claims that may be asserted against us or any of our officers;
regulatory developments affecting our electroporation equipment and product candidates or those of our competitors;
debt service obligations on the Notes and Korean Bonds;
our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and
if any of our products receives regulatory approval, the levels of underlying demand for our products.
If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
If we are unable to obtain FDA approval of our products, we will not be able to commercialize them in the United States.
We need FDA approval prior to marketing our electroporation equipment and products in the United States. If we fail to obtain FDA approval to market our electroporation equipment and product candidates, we will be unable to sell our products in the United States, which will significantly impair our ability to generate any revenues.
This regulatory review and approval process, which includes evaluation of pre-clinical studies and clinical trials of our products as well as the evaluation of our manufacturing processes and our third-party contract manufacturers' facilities, is lengthy, expensive and uncertain. To receive approval, we must, among other things, demonstrate with substantial evidence

from well-controlled clinical trials that our electroporation equipment and product candidates are both safe and effective for each indication for which approval is sought. Satisfaction of the approval requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the product. We do not know if or when we might receive regulatory approvals for our electroporation equipment and any of our product candidates currently under development. Moreover, any approvals that we obtain may not cover all of the clinical indications for which we are seeking approval, or could contain significant limitations in the form of narrow indications, warnings, precautions or contra-indications with respect to conditions of use. In such event, our ability to generate revenues from such products would be greatly reduced and our business would be harmed.
The FDA has substantial discretion in the approval process and may either refuse to consider our application for substantive review or may form the opinion after review of our data that our application is insufficient to allow approval of our electroporation equipment and product candidates. If the FDA does not consider or approve our application, it may require that we conduct additional clinical, pre-clinical or manufacturing validation studies and submit that data before it will reconsider our application. Depending on the extent of these or any other studies, approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to make our applications approvable. If any of these outcomes occur, we may be forced to abandon one or more of our applications for approval, which might significantly harm our business and prospects.

It is possible that none of our products or any product we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us or our collaborators to commence product sales. Any delay in obtaining, or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our products, generating revenues and achieving and sustaining profitability.
Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
Clinical testing is expensive and can take many years to complete, and its outcome is uncertain. Failure can occur at any time during the clinical trial process. The results of pre-clinical studies and early clinical trials of our products may not be predictive of the results of later-stage clinical trials. Results from one study may not be reflected or supported by the results of similar studies. Results of an animal study may not be indicative of results achievable in human studies. Human-use equipment and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical studies and initial clinical testing. The time required to obtain approval by the FDA and similar foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials, depending upon numerous factors. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change. We have not obtained regulatory approval for any human-use products.
 
Our products could fail to complete the clinical trial process for many reasons, including the following:
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our electroporation equipment and a product candidate are safe and effective for any indication;
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
we may not be successful in enrolling a sufficient number of participants in clinical trials;
we may be unable to demonstrate that our electroporation equipment and a product candidate's clinical and other benefits outweigh its safety risks;
we may be unable to demonstrate that our electroporation equipment and a product candidate presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials;
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application or other submission or to obtain regulatory approval in the United States or elsewhere;
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of us or third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and

the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Our product candidates are combination products regulated under both the biologic and device regulations of the Public Health Service Act and Federal Food, Drug, and Cosmetic Act. Third-party manufacturers may not be able to comply with current good manufacturing practices, or cGMP, regulations, regulations applicable to biologic/device combination products, including applicable provisions of the FDA’s drug cGMP regulations, device cGMP requirements embodied in the Quality System Regulation, or QSR, or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our product candidates.
Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.
Delays in the commencement or completion of clinical testing could significantly affect our product development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. In addition, ongoing clinical trials may not be completed on schedule, or at all, and could be placed on a hold by the regulators for various reasons. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:
obtaining regulatory approval to commence a clinical trial;
adverse results from third party clinical trials involving gene based therapies and the regulatory response thereto;
reaching agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
future bans or stricter standards imposed on gene based therapy clinical trials;
manufacturing sufficient quantities of our electroporation equipment and product candidates for use in clinical trials;

obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;
slower than expected recruitment and enrollment of patients to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for similar indications;
conducting clinical trials with sites internationally due to regulatory approvals and meeting international standards;
retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up;
collecting, reviewing and analyzing our clinical trial data; and
global unrest, terrorist activities, and economic and other external factors.
Clinical trials may also be delayed as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated by us, the FDA, the IRB overseeing the clinical trial at issue, any of our clinical trial sites with respect to that site, or other regulatory authorities due to a number of factors, including:
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
unforeseen safety issues; and
lack of adequate funding to continue the clinical trial.
 
If we experience delays in completion of, or if we terminate, any of our clinical trials, the commercial prospects for our electroporation equipment and our product candidates may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Further, delays in the commencement or completion of clinical trials may adversely affect the trading price of our common stock.
We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our product candidates.

We and our collaborators have entered into agreements with CROs to provide monitors for and to manage data for our on-going clinical programs. We and the CROs conducting clinical trials for our electroporation equipment and product candidates are required to comply with current good clinical practices, or GCPs, regulations and guidelines enforced by the FDA for all of our products in clinical development. The FDA enforces GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or the CROs conducting clinical trials of our product candidates fail to comply with applicable GCPs, the clinical data generated in the clinical trials may be deemed unreliable and the FDA may require additional clinical trials before approving any marketing applications.
If any relationships with CROs terminate, we or our collaborators may not be able to enter into arrangements with alternative CROs. In addition, these third-party CROs are not our employees, and we cannot control whether or not they devote sufficient time and resources to our on-going clinical programs or perform trials efficiently. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could harm our competitive position. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements, or for other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. Cost overruns by or disputes with our CROs may significantly increase our expenses.
Even if our products receive regulatory approval, they may still face future development and regulatory difficulties.
Even if United States regulatory approval is obtained, the FDA may still impose significant restrictions on a product's indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. This governmental oversight may be particularly strict with respect to gene based therapies. Our products will also be subject to ongoing FDA requirements governing the labeling, packaging, storage, advertising, promotion, record keeping and submission of safety and other post-market information. For example, the FDA strictly regulates the promotional claims that may be made about medical products. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. However, companies may in certain circumstances share truthful and not misleading information that is otherwise consistent with the product’s FDA approved labeling. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, regulations. If we or a regulatory agency discover previously unknown problems with a product, such as

adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:
issue Warning Letters or untitled letters;
impose civil or criminal penalties;
suspend regulatory approval;
suspend any ongoing clinical trials;
refuse to approve pending applications or supplements to applications filed by us;
impose restrictions on operations, including costly new manufacturing requirements; or
seize or detain products or require us to initiate a product recall.
Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.
In order to market any electroporation equipment and product candidates outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects detailed above regarding FDA approval in the United States. Such effects include the risks that our product candidates may not

be approved for all indications requested, which could limit the uses of our product candidates and have an adverse effect on their commercial potential or require costly, post-marketing follow-up studies.

We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability.
The use of our electroporation equipment and synthetic vaccine candidates in clinical trials and the sale of any products for which we obtain marketing approval expose us to the risk of product liability claims. Product liability claims might be brought against us by consumers, health carehealthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. For example, pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism, and these companies have incurred material costs to defend these claims. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in:
decreased demand for our product candidates;
impairment of our business reputation;
withdrawal of clinical trial participants;
costs of related litigation;
distraction of management's attention from our primary business;
substantial monetary awards to patients or other claimants;
loss of revenues; and
inability to commercialize our products.
We have obtained product liability insurance coverage for our clinical trials, but our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our business.

We currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenues.
We currently do not have a sales organization for the marketing, sales and distribution of our electroporation equipment and product candidates. In order to commercialize any products, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We contemplate establishing our own sales force or seeking third-party partners to sell our products. The establishment and development of our own sales force to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to successfully develop this capability. We will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. To the extent we rely on third parties to commercialize our approved products, if any, we will receive lower revenues than if we commercialized these products ourselves. In addition, we may have little or no control over the sales efforts of third parties involved in our commercialization efforts. In the event we are unable to develop our own marketing and sales force or collaborate with a third-party marketing and sales organization, we would not be able to commercialize our product candidates which would negatively impact our ability to generate product revenues.
If any of our products for which we receive regulatory approval does not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
The commercial success of our electroporation equipment and product candidates for which we obtain marketing approval from the FDA or other regulatory authorities will depend upon the acceptance of these products by both the medical community and patient population. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary for optimal commercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:
our ability to provide acceptable evidence of safety and efficacy;
the relative convenience and ease of administration;

the prevalence and severity of any actual or perceived adverse side effects;
limitations or warnings contained in a product's FDA-approved labeling, including, for example, potential “black box” warnings
availability of alternative treatments;
pricing and cost effectiveness;
the effectiveness of our or any future collaborators' sales and marketing strategies;
our ability to obtain sufficient third-party coverage orand adequate reimbursement; and
the willingness of patients to pay out of pocket in the absence of third-party coverage.
If our electroporation equipment and product candidates are approved but do not achieve an adequate level of acceptance by physicians, health carehealthcare payors and patients, we may not generate sufficient revenue from these products, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.
We are subject to uncertainty relating to coverage and reimbursement policies which, if not favorable to our product candidates, could hinder or prevent our products' commercial success.
OurPatients in the United States and elsewhere generally rely on third-party payors to reimburse part or all of the costs associated with their prescription drugs and medical treatments. Accordingly, our ability to commercialize our electroporation equipment and product candidates successfully will depend in part on the extent to which governmental authorities, including Medicare and Medicaid, private health insurers and other third-party payors establish appropriate coverage and reimbursement levels for our product candidates and related treatments. As a threshold for coverage and reimbursement, third-party payors generally require that drug products have been approved for marketing by the FDA.
Significant uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. Coverage decisions may not favor new products when more established or lower cost therapeutic alternatives are already available. Even if we obtain coverage for a given product, the associated reimbursement rate may not be adequate to cover our costs, including research, development, intellectual property, manufacture, sale and distribution expenses, or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless reimbursement is adequate to cover all or a significant portion of the cost of our drug products.
Additionally, some of our products, if approved, will be provided under the supervision of a physician. When used in connection with medical procedures, our product candidates may not be reimbursed separately but their cost may instead be bundled as part of the payment received by the provider for the procedure only. Separate reimbursement for the product itself or the treatment or procedure in which our product is used may not be available. A decision by a third-party payor not to cover or separately reimburse for our product candidates or procedures using our product candidates, could reduce physician utilization of our products once approved.
Coverage and reimbursement policies for drug products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for drug products among third-party payors in the United States. There may be significant delays in obtaining coverage and reimbursement as the process of determining coverage and reimbursement is often time consuming and costly which will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage or adequate reimbursement will be obtained. It is difficult to predict at this time what government authorities and third-party payors will decide with respect to coverage and reimbursement for our products.
A significant trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors alsohave attempted to control costs by limiting coverage and the amount of reimbursement for particular products and services. Third-party payors are increasingly challenging the effectiveness of and prices charged for medical products and services. Moreover, the U.S. government, state legislatures and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government paid healthcare costs, including price controls, restrictions on reimbursement and coverage and requirements for substitution of generic products for branded prescription drugs. We may not be able to obtain third-party payor coverage or reimbursement for our products in whole or in part.
Healthcare reform measures could hinder or prevent our products' commercial success.
In both the United States and certain foreign jurisdictions there have been, and we anticipate there will continue to be, a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell any of our products profitably. In the United States, the Federalfederal government enacted healthcare reform legislation, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA. We believe there could be continuing trends towards expanding coverage to more individuals, containing health care costs and improving quality. AtAmong the same time, the rebates, discounts, taxes and other costs associated with the ACA are expected to be a significant costACA’s provisions of importance to the pharmaceutical industry.industry are that it:

imposed an annual excise tax of 2.3% on any entity that manufactures or imports medical devices offered for sale in the United States, with limited exceptions, although the effective rate paid may be lower. Under the Consolidated Appropriations Act of 2016, the excise tax was suspended through December 31, 2017, and under the continuing resolution on appropriations for fiscal year 2018, or 2018 Appropriations Resolution, signed by President Trump on January 22, 2018, was further suspended through December 31, 2019;
created an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs;
increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;
created new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics that are inhaled, infused, instilled, implanted or injected;
expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
expanded the entities eligible for discounts under the Public Health program;
created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
established a Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began on January 1, 2011; and
created a licensure framework for follow on biologic products.
Some of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance and delaying the implementation of certain ACA-mandated fees. On December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017. While the Texas U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA and our business.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute will remain in effect through 2027 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
Further there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, the Trump administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. On January 31, 2019, the U.S. Department of Health and Human Services, Office of Inspector General, proposed modifications to the federal healthcare program Anti-Kickback Statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations. While some of these and other proposed measures may require additional

authorization to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to make and implement healthcare reforms may adversely affect:
our ability to set a price we believe is fair for our products;
our ability to generate revenues and achieve or maintain profitability;
the availability of capital; and
our ability to obtain timely approval of our products.
If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
Certain federal, state, local and stateforeign healthcare laws and regulations pertaining to fraud and abuse, andtransparency, patients' rights, may beand privacy are applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business, without limitation. The laws that may affect our ability to operate include:
the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, people from soliciting, receiving or providing remuneration, directly or indirectly, to induce or reward either the referral of an individual, foror ordering, or leasing of an item, or service or the purchasing or ordering of a good, facility or service, for which payment may be made underby a federal healthcare programsprogram such as Medicare or Medicaid. The intent standard under the Medicare and Medicaid programs;federal healthcare program Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Further, the ACA codified case law that a claim including items or services resulting from a violation of the federal healthcare program Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;
federal civil and criminal false claims laws, including the civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
the ACA expands the government's investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the False Claims Act and the Anti-Kickback Statute to make it easier to bring suit under those statutes;
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare mattersmatters. Similar to the federal healthcare program Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;information on certain individuals and entities;
the Physician Payments Sunshine Act, created under the ACA, which requires pharmaceutical companies to record any transfers of value made to doctors and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members, and to annually report such data to CMS;
the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;
the U.S. Foreign Corrupt Practices Act, which, among other things, prohibits companies issuing stock in the U.S. from bribing foreign officials for government contracts and other business; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state and local laws requiring the registration of pharmaceutical sales and medical representatives, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.efforts; and
Additionally, the compliance environment is changing, with more states,additional state and local laws such as laws in California and Massachusetts, mandatingwhich mandate implementation of compliance programs, compliance with industry ethics codes, and spending limits, and other states,state and local laws, such as laws in Vermont, Maine, and Minnesota requiringwhich require reporting to state governments of gifts, compensation, and other remuneration to physicians. Under the ACA, pharmaceutical companies are required to record any transfers of value made to doctors and teaching hospitals and to disclose such data to HHS. These laws all provide for penalties for non-compliance.
The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may run afoul of one or more laws.

We will be required to spend substantial time and money to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, which require strict compliance in order to offer protection, it is possible that governmental authorities may conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity and/or other oversight obligations, contractual damages, reputational harm, and the curtailment or restructuring of our operations. Any such penalties damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

If we and the contract manufacturers upon whom we rely fail to produce our systems and product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates.
We manufacture some components of our electroporation systems and utilize the services of contract manufacturers to manufacture the remaining components of these systems and our product supplies for clinical trials. The manufacture of our systems and product supplies requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers often encounter difficulties in production, particularly in scaling up for commercial production. These problems include difficulties with production costs and yields, quality control, including stability of the equipment and product candidates and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. If we or our manufacturers were to encounter any of these difficulties or our manufacturers otherwise fail to comply with their obligations to us, our ability to provide our electroporation equipment to our partners and products to patients in our clinical trials or to commercially launch a product would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase the costs associated with maintaining our clinical trial program and, depending upon the period of delay, require us to commence new trials at significant additional expense or terminate the trials completely.
In addition, all manufacturers of our products must comply with cGMP requirements enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance and the generation and maintenance of records and documentation. Manufacturers of our products may be unable to comply with these cGMP requirements and with other FDA, state and foreign regulatory requirements. We have little control over our manufacturers' compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of any product is compromised due to our or our manufacturers' failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products, and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatory submissions, approvals or commercialization of our products, entail higher costs or result in our being unable to effectively commercialize our products. Furthermore, if our manufacturers fail to deliver the required commercial quantities on a timely basis, pursuant to provided specifications and at commercially reasonable prices, we may be unable to meet demand for our products and would lose potential revenues.
Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow.
We may acquire, in-license, develop and/or market additional products and product candidates. The success of these actions depends partly upon our ability to identify, select and acquire promising product candidates and products.
The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.
In addition, future acquisitions may entail numerous operational and financial risks, including:
exposure to unknown liabilities;

disruption of our business and diversion of our management's time and attention to develop acquired products or technologies;
incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
higher than expected acquisition and integration costs;
increased amortization expenses;
difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
inability to retain key employees of any acquired businesses.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities.
Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
Our and our third-party manufacturers' activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In the event of an accident, state or federal authorities may curtail the use of these materials and interrupt our business operations. If we are subject to any liability as a result of our or our third-party manufacturers' activities involving hazardous materials, our business and financial condition may be adversely affected.
We may be subject to stockholder litigation, which would harm our business and financial condition.
We may have actions brought against us by stockholders relating to past transactions, changes in our stock price or other matters. Any such actions could give rise to substantial damages, and thereby have a material adverse effect on our consolidated financial position, liquidity, or results of operations. Even if an action is not resolved against us, the uncertainty and expense associated with stockholder actions could harm our business, financial condition and reputation. Litigation can be costly, time-consuming and disruptive to business operations. The defense of lawsuits could also result in diversion of our management's time and attention away from business operations, which could harm our business.
Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.
Our results of operations could be materially affected by economic conditions generally, both in the United States and elsewhere around the world. Concerns over inflation, energy costs, geopolitical issues and the availability and cost of credit have in the past and may continue to contribute to increased volatility and diminished expectations for the economy and the markets going forward. Market upheavals may have an adverse effect on us. In the event of a market downturn, our results of operations could be adversely affected. Our future cost of equity or debt capital and access to the capital markets could be adversely affected, and our stock price could decline. There may be disruption in or delay in the performance of our third-party contractors and suppliers. If our contractors, suppliers and partners are unable to satisfy their contractual commitments, our business could suffer. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits, and we may experience losses on these deposits.

We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.
We rely to a large extent upon sophisticated information technology systems to operate our businesses, some of which are managed, hosted provided and/or used for third-parties or their vendors. We collect, store and transmit large amounts of confidential information, and we deploy and operate an array of technical and procedural controls to maintain the confidentiality and integrity of such confidential information. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations. The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination or intentional destruction of confidential information stored in our or our third-partythird-

party providers' systems, portable media or storage devices. We could also experience a business interruption, theft of confidential information or reputational damage from industrial espionage attacks, malware or other cyber-attacks, which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party providers. While we have invested in the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us.
The recently passed comprehensiveChanges in tax reform billlaws could adversely affect our business and financial condition.
On December 22, 2017, President Trump signed into law new legislation, known as the Tax Cuts and Jobs Act of 2017, that significantly revisesrevised the Internal Revenue Code of 1986, as amended, or the Code. The newly enactednew federal income tax law, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35 percent to a flat rate

of 21 percent, limitation of the tax deduction for interest expense to 30 percent of adjusted earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80 percent of current-year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions). Notwithstanding the reduction in the corporate income tax rate, the overall impact of the new federal tax law is uncertain and our business and financial condition could be adversely affected. In addition, it is uncertain if and to what extent various states will conform to the newly enacted federal tax law.
Changes in funding for the FDA and other government agencies could hinder our ability to hire and retain key leadership and other personnel, or otherwise prevent new products from being developed or commercialized in a timely manner, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Risks Related to Our Intellectual Property
It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
Our commercial success will depend in part on obtaining and maintaining patent, trademark, trade secret, and other intellectual property protection relating to our electroporation equipment and product candidates, as well as successfully defending these intellectual property rights against third-party challenges.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. The laws and regulations regarding the breadth of claims allowed in biotechnology patents have evolved over recent years and continues to undergo review and revision, both in the United States and abroad. The biotechnology patent situation outside the United States can be even more uncertain depending on the country. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our licensed patents, our patents or in third-party patents, nor can we predict the likelihood of our patents surviving a patent validity challenge.

The degree of future protection for our intellectual property rights is uncertain, because legal decision-making can be unpredictable, thereby often times resulting in limited protection, which may not adequately protect our rights or permit us to gain or keep our competitive advantage, or resulting in an invalid or unenforceable patent. For example:
we, or the parties from whom we have acquired or licensed patent rights, may not have been the first to file the underlying patent applications or the first to make the inventions covered by such patents;
the named inventors or co-inventors of patents or patent applications that we have licensed or acquired may be incorrect, which may give rise to inventorship and ownership challenges;
others may develop similar or alternative technologies, or duplicate any of our products or technologies that may not be covered by our patents, including design-arounds;
pending patent applications may not result in issued patents;
the issued patents covering our products and technologies may not provide us with any competitive advantages or have any commercial value;
the issued patents may be challenged and invalidated, or rendered unenforceable;
the issued patents may be subject to reexamination, which could result in a narrowing of the scope of claims or cancellation of claims found unpatentable;
we may not develop or acquire additional proprietary technologies that are patentable;
our trademarks may be invalid or subject to a third party's prior use; or
our ability to enforce our patent rights will depend on our ability to detect infringement, and litigation to enforce patent rights may not be pursued due to significant financial costs, diversion of resources, and unpredictability of a favorable result or ruling.
We depend, in part, on our licensors and collaborators to protect a portion of our intellectual property rights. In such cases, our licensors and collaborators may be primarily or wholly responsible for the maintenance of patents and prosecution of patent applications relating to important areas of our business. If any of these parties fail to adequately protect these products with issued patents, our business and prospects would be harmed significantly.
We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our trade secrets to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any

of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
If we or our licensors fail to obtain or maintain patent protection or trade secret protection for our product candidates or our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.
From time to time, U.S. and other policymakers have proposed reforming the patent laws and regulations of their countries. In September 2011 the America Invents Act (the Act) was signed into law. The Act changed the current “first-to-invent” system to a system that awards a patent to the “first-inventor-to-file” for an application for a patentable invention. The Act also created a procedure to challenge newly issued patents in the patent office via post-grant proceedings and new inter parties reexamination proceedings. These changes may make it easier for competitors to challenge our patents, which could result in increased competition and have a material adverse effect on our product sales, business and results of operations. The changes may also make it harder to challenge third-party patents and place greater importance on being the first inventor to file a patent application on an invention.
If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
Other companies may have or may acquire intellectual property rights that could be enforced against us. If they do so, we may be required to alter our technologies, pay licensing fees or cease activities. If our products or technologies infringe the intellectual property rights of others, they could bring legal action against us or our licensors or collaborators claiming damages and seeking to enjoin any activities that they believe infringe their intellectual property rights.
Because patent applications can take many years to issue, and there is a period when the application remains undisclosed to the public, there may be currently pending applications unknown to us or reissue applications that may later result in issued

patents upon which our products or technologies may infringe. There could also be existing patents of which we are unaware that our products or technologies may infringe. In addition, if third parties file patent applications or obtain patents claiming products or technologies also claimed by us in pending applications or issued patents, we may have to participate in interference or derivation proceedings in the United States Patent and Trademark Office to determine priority or derivation of the invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our filed foreign patent applications.
If a third party claims that we infringe its intellectual property rights, it could cause our business to suffer in a number of ways, including:
we may become involved in time-consuming and expensive litigation, even if the claim is without merit, the third party's patent is invalid or we have not infringed;
we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a third party's patent;
we may be enjoined by a court to stop making, selling or licensing our products or technologies without a license from a patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and
we may have to redesign our products so that they do not infringe upon others' patent rights, which may not be possible or could require substantial investment or time.
If any of these events occur, our business could suffer and the market price of our common stock may decline.
Risks Related to Our Common Stock
The price of our common stock may be volatile, and an investment in our common stock could decline substantially in value.
In light of our small size and limited resources, as well as the uncertainties and risks that can affect our business and industry, our stock price may be highly volatile and can be subject to substantial drops, with or even in the absence of news affecting our business. Period to period comparisons are not indicative of future performance. The following factors, in addition to the other risk factors described in this annual report, and the potentially low volume of trades in our common stock, may have a significant impact on the market price of our common stock, some of which are beyond our control:
developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations;

fluctuating public or scientific interest in the potential for influenza pandemic or other applications for our vaccine or other product candidates;
our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;
fluctuations in our operating results;
announcements of technological innovations;
new products or services that we or our competitors offer;
changes in the structure of healthcare payment systems;
the initiation, conduct and/or outcome of intellectual property and/or litigation matters;
changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;
conditions or trends in bio-pharmaceutical or other healthcare industries;
regulatory developments in the United States and other countries;
negative perception of gene based therapy;
changes in the economic performance and/or market valuations of other biotechnology and medical device companies;
additions or departures of key personnel;
sales or other transactions involving our common stock;
changes in our capital structure;
sales or other transactions by executive officers or directors involving our common stock;
changes in accounting principles;

global unrest, terrorist activities, and economic and other external factors; and
catastrophic weather and/or global disease pandemics.
The stock market in general has recently experienced relatively large price and volume fluctuations. In particular, the market prices of securities of smaller biotechnology and medical device companies have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of the common stock, which could cause a decline in the value of the common stock. In addition, price volatility may increase if the trading volume of our common stock remains limited or declines.
Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock.
Our amended and restated certificate of incorporation contains provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:
the authority of our board of directors to issue shares of undesignated preferred stock and to determine the rights, preferences and privileges of these shares, without stockholder approval;
all stockholder actions must be effected at a duly called meeting of stockholders and not by written consent; and
the elimination of cumulative voting.
In addition, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors, including to delay or impede a merger, tender offer or proxy contest involving our company. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.
We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.
We have paid no cash dividends on our common stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt or credit facility may preclude or limit our ability to pay any dividends. As a result, capital appreciation, if any, of our common stock will be yourthe sole source of potential gain for the foreseeable future.

ITEM 2.    UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable.


ITEM 3.    DEFAULTS UPON SENIOR SECURITIES
Not applicable.

ITEM 4.    MINE SAFETY DISCLOSURES
Not applicable.

ITEM 5.    OTHER INFORMATION
Not applicable.

ITEM 6.    EXHIBITS
(a)    Exhibits


Exhibit
Number
 Description of Document
 
   
 
   
 
   
101.INS XBRL Instance Document.
   
101.SCH XBRL Taxonomy Extension Schema Document
   
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.
   
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.
   
101.LAB XBRL Taxonomy Extension Label Linkbase Document.
   
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.


*
     This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.




INOVIO PHARMACEUTICALS, INC.

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
  Inovio Pharmaceuticals, Inc.
    
Date:August 7, 20188, 2019By/s/    J. JOSEPH KIM        
   
J. Joseph Kim
President, Chief Executive Officer and Director (On Behalf of the Registrant)
    
Date:August 7, 20188, 2019By/s/    PETER KIES      
   
Peter Kies
Chief Financial Officer (Principal Financial and Accounting Officer)


4450