x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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) |
COMMON STOCK, $0.001 PAR VALUE | Nasdaq Global Select Market | |
(Title of Class) | (Name of Each Exchange on Which Registered) |
Large accelerated filer | ☐ | Accelerated filer | x | |
Non-accelerated filer | ☐ | (Do not check if a smaller reporting company) | Smaller reporting company | ☐ |
Emerging growth company | ☐ |
March 31, 2018 | December 31, 2017 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 37,508,863 | $ | 23,786,579 | |||
Short-term investments | 75,259,889 | 103,638,844 | |||||
Accounts receivable | 5,147,851 | 6,003,205 | |||||
Accounts receivable from affiliated entities | 2,242,569 | 486,619 | |||||
Prepaid expenses and other current assets | 2,002,015 | 2,600,906 | |||||
Prepaid expenses and other current assets from affiliated entities | 1,674,981 | 1,846,007 | |||||
Total current assets | 123,836,168 | 138,362,160 | |||||
Fixed assets, net | 17,486,103 | 18,320,176 | |||||
Investment in affiliated entity - GeneOne | 10,467,711 | 9,069,401 | |||||
Investment in affiliated entity - PLS | 3,307,192 | 2,325,079 | |||||
Intangible assets, net | 5,605,667 | 6,009,729 | |||||
Goodwill | 10,513,371 | 10,513,371 | |||||
Other assets | 2,448,628 | 2,639,354 | |||||
Total assets | $ | 173,664,840 | $ | 187,239,270 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 15,825,207 | $ | 23,278,798 | |||
Accounts payable and accrued expenses due to affiliated entities | 1,298,741 | 926,943 | |||||
Accrued clinical trial expenses | 8,428,881 | 8,611,892 | |||||
Common stock warrants | 488,636 | 360,795 | |||||
Deferred revenue | 24,088,288 | 1,175,353 | |||||
Deferred revenue from affiliated entities | 56,167 | 174,110 | |||||
Deferred rent | 928,098 | 877,535 | |||||
Other liabilities | 261,325 | — | |||||
Total current liabilities | 51,375,343 | 35,405,426 | |||||
Deferred revenue, net of current portion | 203,322 | 215,853 | |||||
Deferred rent, net of current portion | 8,966,846 | 9,104,416 | |||||
Deferred tax liabilities | 24,766 | 24,766 | |||||
Total liabilities | 60,570,277 | 44,750,461 | |||||
Stockholders’ equity: | |||||||
Preferred stock | — | — | |||||
Common stock | 90,705 | 90,358 | |||||
Additional paid-in capital | 668,844,504 | 665,775,504 | |||||
Accumulated deficit | (555,475,779 | ) | (523,356,317 | ) | |||
Accumulated other comprehensive loss | (461,136 | ) | (117,005 | ) | |||
Total Inovio Pharmaceuticals, Inc. stockholders’ equity | 112,998,294 | 142,392,540 | |||||
Non-controlling interest | 96,269 | 96,269 | |||||
Total stockholders’ equity | 113,094,563 | 142,488,809 | |||||
Total liabilities and stockholders’ equity | $ | 173,664,840 | $ | 187,239,270 |
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Revenues: | |||||||
Revenue under collaborative research and development arrangements | $ | 1,289,046 | $ | 4,288,586 | |||
Revenue under collaborative research and development arrangements with affiliated entities | 148,008 | 233,330 | |||||
Grants and miscellaneous revenue | 92,590 | 5,240,233 | |||||
Grants and miscellaneous revenue from affiliated entity | — | 614,036 | |||||
Total revenues | 1,529,644 | 10,376,185 | |||||
Operating expenses: | |||||||
Research and development | 24,577,751 | 24,542,504 | |||||
General and administrative | 9,698,015 | 7,767,589 | |||||
Total operating expenses | 34,275,766 | 32,310,093 | |||||
Loss from operations | (32,746,122 | ) | (21,933,908 | ) | |||
Other income (expense): | |||||||
Interest and other income, net | 312,523 | 340,341 | |||||
Change in fair value of common stock warrants | (127,841 | ) | 116,477 | ||||
Gain (loss) on investment in affiliated entities | 2,380,423 | (1,608,817 | ) | ||||
Net loss before provision for income taxes | (30,181,017 | ) | (23,085,907 | ) | |||
Provision for income taxes | (2,169,811 | ) | — | ||||
Net loss | $ | (32,350,828 | ) | $ | (23,085,907 | ) | |
Net loss per share | |||||||
Basic | $ | (0.36 | ) | $ | (0.31 | ) | |
Diluted | $ | (0.36 | ) | $ | (0.31 | ) | |
Weighted average number of common shares outstanding | |||||||
Basic | 90,451,791 | 74,152,609 | |||||
Diluted | 90,451,791 | 74,300,884 |
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Net loss | $ | (32,350,828 | ) | $ | (23,085,907 | ) | |
Other comprehensive income (loss): | |||||||
Unrealized loss on investment in affiliated entity | — | (749,961 | ) | ||||
Unrealized gain (loss) on short-term investments | (112,765 | ) | 203,540 | ||||
Comprehensive loss | $ | (32,463,593 | ) | $ | (23,632,328 | ) |
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (32,350,828 | ) | $ | (23,085,907 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation | 897,709 | 522,298 | |||||
Amortization of intangible assets | 404,062 | 406,299 | |||||
Change in value of common stock warrants | 127,841 | (116,477 | ) | ||||
Stock-based compensation | 3,575,750 | 5,372,797 | |||||
Amortization of premiums on investments | 55,522 | 69,004 | |||||
Loss on short-term investments | 253,316 | 51,706 | |||||
Deferred rent | (87,007 | ) | 1,208,085 | ||||
Loss (gain) on equity investment in affiliated entities | (2,380,423 | ) | 1,608,817 | ||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | 855,354 | 5,956,611 | |||||
Accounts receivable from affiliated entity | (1,755,950 | ) | (484,550 | ) | |||
Prepaid expenses and other current assets | 598,891 | (2,457,068 | ) | ||||
Prepaid expenses and other current assets from affiliated entity | 171,026 | (304,345 | ) | ||||
Other assets | 190,726 | 587,993 | |||||
Accounts payable and accrued expenses | (6,363,762 | ) | (5,643,054 | ) | |||
Accrued clinical trial expenses | (183,011 | ) | (458,516 | ) | |||
Accounts payable and accrued expenses due to affiliated entity | 371,798 | (543,410 | ) | ||||
Deferred revenue | 22,900,404 | 2,207,277 | |||||
Deferred revenue from affiliated entity | (117,943 | ) | (125,000 | ) | |||
Other liabilities | 261,325 | — | |||||
Net cash used in operating activities | (12,575,200 | ) | (15,227,440 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of investments | (9,568,082 | ) | (5,925,232 | ) | |||
Maturities of investments | 37,525,434 | 24,882,273 | |||||
Purchases of capital assets | (1,153,465 | ) | (789,257 | ) | |||
Net cash provided by investing activities | 26,803,887 | 18,167,784 | |||||
Cash flows from financing activities: | |||||||
Proceeds (payments) for stock option and warrant exercises, net of tax payments | (506,403 | ) | 826,437 | ||||
Net cash (used in) provided by financing activities | (506,403 | ) | 826,437 | ||||
Increase in cash and cash equivalents | 13,722,284 | 3,766,781 | |||||
Cash and cash equivalents, beginning of period | 23,786,579 | 19,136,472 | |||||
Cash and cash equivalents, end of period | $ | 37,508,863 | $ | 22,903,253 | |||
Supplemental disclosure of non-cash activities | |||||||
Change in amounts accrued for purchases of property and equipment | $ | 164,288 | $ | 511,052 |
Balances Without Adoption of Topic 606 at March 31, 2018 | Impact of Adopting Topic 606 | As reported at March 31, 2018 | |||||||||
Revenues: | |||||||||||
Revenue under collaborative research and development arrangements | $ | 1,289,046 | $ | — | $ | 1,289,046 | |||||
Revenue under collaborative research and development arrangements with affiliated entities | 148,008 | — | 148,008 | ||||||||
Grants and miscellaneous revenue | 1,850,341 | (1,757,751 | ) | 92,590 | |||||||
Grants and miscellaneous revenue from affiliated entity | 464,400 | (464,400 | ) | — | |||||||
Total revenues | 3,751,795 | (2,222,151 | ) | 1,529,644 | |||||||
Operating expenses: | |||||||||||
Research and development | 22,355,600 | (2,222,151 | ) | 24,577,751 | |||||||
General and administrative | 9,698,015 | — | 9,698,015 | ||||||||
Total operating expenses | $ | 32,053,615 | $ | (2,222,151 | ) | $ | 34,275,766 |
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 | ) |
Balance at January 1, 2018 | Additions | Deductions | Balance at March 31, 2018 | ||||||||||||
Contract assets | |||||||||||||||
Accounts receivable from MedImmune | $ | 1,693,530 | $ | 1,339,961 | $ | (3,750 | ) | $ | 3,029,741 | ||||||
Contract liabilities | |||||||||||||||
Deferred revenue - MedImmune | 1,145,500 | 582,500 | (531,583 | ) | 1,196,417 | ||||||||||
Deferred revenue - ApolloBio | — | 23,000,000 | — | 23,000,000 | |||||||||||
Deferred revenue - Other | $ | 271,894 | $ | — | $ | (120,534 | ) | $ | 151,360 |
As of March 31, 2018 | |||||||||||||||||
Contractual Maturity (in years) | Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | |||||||||||||
Mutual funds | --- | $ | 54,509,756 | $ | — | $ | (306,308 | ) | $ | 54,203,448 | |||||||
US corporate debt securities | Less than 2 | 21,211,005 | — | (154,564 | ) | 21,056,441 | |||||||||||
Investment in affiliated entity (PLS) | --- | — | 3,307,192 | — | 3,307,192 | ||||||||||||
Total investments | $ | 75,720,761 | $ | 3,307,192 | $ | (460,872 | ) | $ | 78,567,081 |
As of December 31, 2017 | |||||||||||||||||
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 | |||||||
US corporate debt securities | Less than 2 | 35,210,121 | 3,032 | (140,198 | ) | 35,072,955 | |||||||||||
Investment in affiliated entity (PLS) | --- | — | 2,325,079 | — | 2,325,079 | ||||||||||||
Total investments | $ | 103,986,286 | $ | 2,370,208 | $ | (392,571 | ) | $ | 105,963,923 |
Fair Value Measurements at | |||||||||||||||
March 31, 2018 | |||||||||||||||
Total | Quoted Prices in Active Markets (Level 1) | Significant Other Unobservable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||
Assets: | |||||||||||||||
Money market funds | $ | 1,590,607 | $ | 1,590,607 | $ | — | $ | — | |||||||
Mutual funds | 54,203,448 | — | 54,203,448 | — | |||||||||||
US corporate debt securities | 21,056,441 | — | 21,056,441 | — | |||||||||||
Investment in affiliated entities | 13,774,903 | 13,774,903 | — | — | |||||||||||
Total Assets | $ | 90,625,399 | $ | 15,365,510 | $ | 75,259,889 | $ | — | |||||||
Liabilities: | |||||||||||||||
Common stock warrants | $ | 488,636 | $ | — | $ | — | 488,636 | ||||||||
Total Liabilities | $ | 488,636 | $ | — | $ | — | $ | 488,636 |
Fair Value Measurements at | |||||||||||||||
December 31, 2017 | |||||||||||||||
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 | $ | — | $ | — | |||||||
Mutual funds | 68,565,889 | — | 68,565,889 | — | |||||||||||
US corporate debt securities | 35,072,955 | — | 35,072,955 | — | |||||||||||
Investment in affiliated entities | 11,394,480 | 11,394,480 | — | — | |||||||||||
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 |
Risk-free interest rate | 1.93% |
Expected volatility | 65% |
Expected life in years | 0.45 |
Dividend yield | — |
Balance at December 31, 2017 | $ | 360,795 | |
Increase attributable to change in fair value of common stock warrants | 127,841 | ||
Balance at March 31, 2018 | $ | 488,636 |
March 31, 2018 | December 31, 2017 | ||||||||||||||||||||||||
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 | |||||||||||||
Definite lived: | |||||||||||||||||||||||||
Patents | 8 – 17 | 5,802,528 | (5,696,775 | ) | 105,753 | 5,802,528 | (5,681,673 | ) | 120,855 | ||||||||||||||||
Licenses | 8 – 17 | 1,323,761 | (1,197,796 | ) | 125,965 | 1,323,761 | (1,190,609 | ) | 133,152 | ||||||||||||||||
CELLECTRA®(b) | 5 – 11 | 8,106,270 | (7,358,878 | ) | 747,392 | 8,106,270 | (7,252,108 | ) | 854,162 | ||||||||||||||||
GHRH(b) | 11 | 335,314 | (279,868 | ) | 55,446 | 335,314 | (271,948 | ) | 63,366 | ||||||||||||||||
Bioject(c) | 2 – 15 | 5,100,000 | (1,616,389 | ) | 3,483,611 | 5,100,000 | (1,405,556 | ) | 3,694,444 | ||||||||||||||||
Other(d) | 18 | 4,050,000 | (2,962,500 | ) | 1,087,500 | 4,050,000 | (2,906,250 | ) | 1,143,750 | ||||||||||||||||
Total intangible assets | 24,717,873 | (19,112,206 | ) | 5,605,667 | 24,717,873 | (18,708,144 | ) | 6,009,729 | |||||||||||||||||
Total goodwill and intangible assets | $ | 35,231,244 | $ | (19,112,206 | ) | $ | 16,119,038 | $ | 35,231,244 | $ | (18,708,144 | ) | $ | 16,523,100 |
(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. |
Outstanding as of | |||||||||||
Authorized | Issued | March 31, 2018 | December 31, 2017 | ||||||||
Common Stock, par value $0.001 per share | 600,000,000 | 90,704,931 | 90,704,931 | 90,357,644 | |||||||
Series C Preferred Stock, par value $0.001 per share | 1,091 | 1,091 | 23 | 23 |
As of March 31, 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 | $ | 488,636 | 284,091 | $ | 360,795 | |||||||||||
Total | 284,091 | $ | 488,636 | 284,091 | $ | 360,795 |
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Numerator | |||||||
Net loss | $ | (32,350,828 | ) | $ | (23,085,907 | ) | |
Adjustment for decrease in fair value of warrant liability | — | (116,477 | ) | ||||
Numerator for use in diluted net loss per share | $ | (32,350,828 | ) | $ | (23,202,384 | ) | |
Denominator | |||||||
Weighted average number of common shares outstanding | 90,451,791 | 74,152,609 | |||||
Effect of dilutive potential common shares | — | 148,275 | |||||
Denominator for use in diluted net loss per share | 90,451,791 | 74,300,884 | |||||
Net loss per share, diluted | $ | (0.36 | ) | $ | (0.31 | ) |
Common Stock Equivalents | 2018 | 2017 | |||
Options to purchase common stock | 9,467,477 | 7,841,669 | |||
Warrants to purchase common stock | 284,091 | — | |||
Restricted stock units | 1,791,886 | 1,376,893 | |||
Convertible preferred stock | 8,456 | 8,456 | |||
Total | 11,551,910 | 9,227,018 |
Three Months Ended March 31, | |||
2018 | 2017 | ||
Risk-free interest rate | 2.72% | 2.24% | |
Expected volatility | 72% | 73% | |
Expected life in years | 6.2 | 6.0 | |
Dividend yield | — | — |
Remainder of 2018 | $ | 2,447,000 | |
2019 | 3,756,000 | ||
2020 | 3,891,000 | ||
2021 | 3,979,000 | ||
2022 | 4,052,000 | ||
Thereafter | 19,975,000 | ||
Total | $ | 38,100,000 |
• | 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. |
• | 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; |
• | 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. |
• | 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; |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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 or reimbursement; and |
• | the willingness of patients to pay out of pocket in the absence of third-party coverage. |
• | 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. |
• | the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, people from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; |
• | federal false claims laws 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 executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; |
• | 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, 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. |
• | 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. |
• | 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 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. |
• | 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; |
• | 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 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. |
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 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings. |
Inovio Pharmaceuticals, Inc. | |||
Date: | May 9, 2018 | By | /s/ J. JOSEPH KIM |
J. Joseph Kim President, Chief Executive Officer and Director (On Behalf of the Registrant) | |||
Date: | May 9, 2018 | By | /s/ PETER KIES |
Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer) |
1. | I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and |
5. | The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): |
a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. |
Date: | May 9, 2018 | /s/ J. JOSEPH KIM |
J. Joseph Kim President, Chief Executive Officer and Director (Principal Executive Officer) |
1. | I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and |
5. | The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): |
a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. |
Date: | May 9, 2018 | /s/ PETER KIES |
Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: | May 9, 2018 | /s/ J. JOSEPH KIM |
J. Joseph Kim President, Chief Executive Officer and Director (Principal Executive Officer) | ||
Date: | May 9, 2018 | /s/ PETER KIES |
Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer) |
Document and Entity Information - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
May 04, 2018 |
|
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2018 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | INOVIO PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001055726 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 90,962,081 |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Mar. 31, 2017 |
|
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (32,350,828) | $ (23,085,907) |
Other comprehensive income (loss): | ||
Unrealized loss on investment in affiliated entity | 0 | (749,961) |
Unrealized gain (loss) on short-term investments | (112,765) | 203,540 |
Comprehensive loss | $ (32,463,593) | $ (23,632,328) |
Organization and Operations |
3 Months Ended |
---|---|
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Operations | Organization and Operations Inovio Pharmaceuticals, Inc. (the “Company” or “Inovio”), a clinical stage biopharmaceutical company, develops active SynCon® DNA immunotherapies and vaccines focused on preventing and treating cancers and infectious diseases. Inovio’s DNA-based immunotherapies, in combination with its proprietary CELLECTRA® delivery devices, are intended to generate optimal antigen production in vivo, in particular functional CD8+ killer T cell and antibody responses, 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® immunotherapies for HPV-caused pre-cancers and cancers; prostate, breast, lung and pancreatic cancers; hepatitis B virus ("HBV"); HIV; Ebola; Middle East Respiratory Syndrome ("MERS"); and Zika virus. The Company's partners and collaborators include MedImmune, LLC, The Wistar Institute, University of Pennsylvania, GeneOne Life Science Inc. ("GeneOne"), ApolloBio Corporation, Regeneron Pharmaceuticals, Inc., Genentech, Inc., Plumbline Life Sciences, Inc., Drexel University, National Microbiology Laboratory of the Public Health Agency of Canada, National Institute of Allergy and Infectious Diseases (“NIAID”), United States Military HIV Research Program (“USMHRP”), U.S. Army Medical Research Institute of Infectious Diseases (“USAMRIID”), National Institutes of Health ("NIH"), HIV Vaccines Trial Network (“HVTN”), Defense Advanced Research Projects Agency (“DARPA”), Parker Institute for Cancer Immunotherapy, and Coalition for Epidemic Preparedness Innovations (“CEPI”). Inovio was incorporated in Delaware in June 2001 and has its principal executive offices in Plymouth Meeting, Pennsylvania. |
Basis of Presentation |
3 Months Ended |
---|---|
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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 March 31, 2018 and the condensed consolidated statements of operations, condensed consolidated statements of comprehensive loss and the condensed consolidated statements of cash flows for the three months ended March 31, 2018 and 2017, 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 for the periods presented. The results of operations for the three months ended March 31, 2018 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2018, 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, 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. The balance sheet at December 31, 2017 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 March 31, 2018 through the date it filed these unaudited condensed consolidated financial statements with the SEC. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Critical Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Critical Accounting Policies | 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 recognize 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 assess 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) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Where a portion of non-refundable, up-front 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-alone 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-front 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. 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. Valuation of Intangible Assets and Goodwill Intangible assets are amortized over their estimated useful lives ranging from 2 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 March 31, 2018 and December 31, 2017, 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 $5.6 million and $6.0 million, respectively. The determination of the value of intangible assets requires management to make estimates and assumptions that affect the Company’s 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 March 31, 2018. 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, 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 9 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. |
Principles of Consolidation |
3 Months Ended |
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Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Principles of Consolidation | Principles of Consolidation 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., VGX and GENEOS Therapeutics, Inc., and records a non-controlling interest for the 15% of VGX Animal Health, Inc., a subsidiary of VGX, that it did not own as of March 31, 2018 and December 31, 2017. All intercompany accounts and transactions have been eliminated upon consolidation. |
Impact of Recently Issued Accounting Standards |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Impact of Recently Issued Accounting Standards | 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 months ended March 31, 2018, $2.2 million was recorded as contra-research and development expense which previously would have been recorded as grant revenue. The following table illustrates the impact that adopting Topic 606 has had on our reported results in the condensed consolidated statement of operations.
ASU No. 2016-01. In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities. 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 gain on investment in affiliated entity related to PLS of $982,000 on the condensed consolidated statement of operations for the three months ended March 31, 2018. 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:
ASU No. 2016-02. In February 2016, the FASB issued ASU No. 2016-02, Leases. Under 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, measured 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, with early adoption permitted. The Company is currently evaluating the impact of the application of this accounting standard update on its financial statements and related disclosures. The Company currently has three operating leases for its office and laboratory spaces in San Diego, California and Plymouth Meeting, Pennsylvania that are expected to be impacted by the standard and result in the present value of the future lease payment presented as right-to-use assets with a corresponding lease liability at the date of adoption. |
Revenue Recognition |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition | 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 three months ended March 31, 2018:
During the three months ended March 31, 2018, the Company recognized total revenue under collaborative research and development and other agreements of $1.3 million from Medimmune, $118,000 from its affiliated entity GeneOne Life Science Inc. ("GeneOne") and $123,000 from various other contracts. Of the total revenue recognized during the three months ended March 31, 2018, $652,000 was in deferred revenue as of December 31, 2017. All revenues recognized during the three months ended March 31, 2018 are attributed to the United States. |
Investments |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | Investments Investments at March 31, 2018 and December 31, 2017 consisted of mutual funds, United States corporate debt securities and an equity investment in the Company's affiliated entity PLS. 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 months ended March 31, 2018 and 2017, $253,000 and $52,000 of net realized loss on investments was recorded, respectively. 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 March 31, 2018, the Company had 28 available-for-sale securities in a gross unrealized loss position, of which 3 with an aggregate total unrealized loss of $28,000 were in such position for longer than 12 months. The following is a summary of available-for-sale securities as of March 31, 2018 and December 31, 2017:
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Marketable Securities and Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities and Fair Value Measurements | 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 three months ended March 31, 2018 or 2017. 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 March 31, 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 December 31, 2017:
Level 1 assets at March 31, 2018 consisted of money market funds held by the Company that are valued at quoted market prices, as well as the Company’s investments in 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, unrealized 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 5. Level 2 assets at March 31, 2018 consisted of US 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 March 31, 2018. Level 3 liabilities at March 31, 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 three months ended March 31, 2018 and 2017, none of these warrants were exercised. As of March 31, 2018, the Company had a $489,000 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 March 31, 2018 are presented below:
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 an increase (decrease) in fair value of $128,000 and $(116,000) for the three months ended March 31, 2018 and 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 three months ended March 31, 2018:
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Goodwill and Intangible Assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets | Goodwill and Intangible Assets The following sets forth the goodwill and intangible assets by major asset class:
Aggregate amortization expense on intangible assets for the three months ended March 31, 2018 and 2017 was $404,000 and $406,000, respectively. Estimated aggregate amortization expense for each of the five succeeding fiscal years is $846,000 for the remainder of fiscal year 2018, $1.1 million for 2019, $547,000 for 2020, $520,000 for 2021, $493,000 for 2022 and $2.1 million for 2023 and subsequent years combined. |
Stockholders' Equity |
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Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity | Stockholders’ Equity The following is a summary of the Company's authorized and issued common and preferred stock as of March 31, 2018 and December 31, 2017:
Common Stock 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. In June 2016, 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 $50.0 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 2.0% 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. There were no sales of common stock under the Sales Agreement during the three months ended March 31, 2018. As of March 31, 2018, the Company has sold an aggregate of 3,596,154 shares of common stock under the Sales Agreement for net proceeds of $30.5 million. Accordingly, the Company may sell up to an additional $18.9 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 5, 2018. 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 March 31, 2018 and December 31, 2017:
Stock Options The Company has a stock-based incentive plan, the 2016 Omnibus Incentive Plan (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 approved by the Company's stockholders on May 13, 2016. 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 6,000,000 shares, provided that commencing with the first business day of each calendar year beginning January 1, 2018, 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 March 31, 2018, there were 8,000,000 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 March 31, 2018, the Company had 3,044,097 shares of common stock available for future grant under the 2016 Incentive Plan, 1,576,224 shares underlying outstanding but unvested restricted stock units and options outstanding to purchase 3,078,555 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 March 31, 2018, the Company had 215,662 shares underlying outstanding but unvested restricted stock units and options outstanding to purchase 6,197,484 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 March 31, 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. |
Net Loss Per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share | 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 and reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock. 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:
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 months ended March 31, 2018 and 2017:
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Stock-Based Compensation |
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Mar. 31, 2018 | |||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||
Stock-Based Compensation | 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:
Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three months ended March 31, 2018 and 2017 was $3.4 million and $5.2 million, respectively, of which $2.1 million and $2.2 million were included in research and development expenses, respectively, and $1.3 million and $3.0 million were included in general and administrative expenses, respectively. At March 31, 2018, there was $8.7 million of total unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.2 years. The weighted average grant date fair value per share, calculated using the Black-Scholes option pricing model, was $2.84 and $4.38 for employee and director stock options granted during the three months ended March 31, 2018 and 2017, respectively. At March 31, 2018, there was $4.4 million of total unrecognized compensation expense related to unvested restricted stock units, which is expected to be recognized over a weighted-average period of 1.7 years. The weighted average grant date fair value per share was $4.29 and $6.68 for restricted stock units granted during the three months ended March 31, 2018 and 2017, respectively. The fair value of options granted to non-employees at the measurement dates were estimated using the Black-Scholes pricing model. Total stock-based compensation expense for options and restricted stock units granted to non-employees for the three months ended March 31, 2018 and 2017 was $140,000 and $131,000, respectively. |
Related Party Transactions |
3 Months Ended |
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Mar. 31, 2018 | |
Related Party Transaction, Due from (to) Related Party [Abstract] | |
Related Party Transactions | Related Party Transactions GeneOne Life Sciences The Company owns 1,644,155 shares of common stock in GeneOne as of March 31, 2018; 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 licensing and other fees from the influenza and Zika collaborations. For the three months ended March 31, 2018 and 2017, the Company recognized revenue from GeneOne of $118,000 and $167,000, respectively. Operating expenses recorded from transactions with GeneOne relate primarily to biologics manufacturing. Operating expenses from GeneOne for the three months ended March 31, 2018 and 2017 were $1.7 million and $428,000, respectively. At March 31, 2018 and December 31, 2017, the Company had an accounts payable and accrued liability balance of $710,000 and $107,000, respectively, related to GeneOne and its subsidiaries. At March 31, 2018 and December 31, 2017, $347,000 and $331,000, 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 March 31, 2018; 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 months ended March 31, 2018 and 2017, the Company recognized revenue from PLS of $30,000 and $67,000, respectively. At March 31, 2018 and December 31, 2017, the Company had an accounts receivable balance of $400,000 and $370,000, respectively, related to PLS. The Wistar Institute One of the Company's directors, Dr. David B. Weiner, is the Executive Vice President and Director of the Vaccine Center of The Wistar Institute ("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 December 2016, the Company received a $6.1 million sub-grant through Wistar to develop a DNA-based monoclonal antibody against the Zika infection. The Company is also a collaborator with Wistar on an Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant from the National Institute of Allergy and Infectious Diseases (NIAID), awarded in 2015. 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 months ended March 31, 2018 the Company recorded $1.8 million as contra-research and development expense from Wistar. For the three months ended March 31, 2017, the Company recognized revenue from Wistar of $614,000. Research and development expenses recorded from Wistar relate primarily to the collaborative research agreements and sub-contract agreements related to the DARPA Ebola grant (see Note 15). Research and development expenses recorded from Wistar for the three months ended March 31, 2018 and 2017 were $402,000 and $543,000, respectively. At March 31, 2018 and December 31, 2017, the Company had an accounts receivable balance of $1.8 million and $117,000, respectively, and an accounts payable and accrued liability balance of $589,000 and $820,000, respectively, related to Wistar. |
Commitments and Contingencies |
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Mar. 31, 2018 | |||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | Commitments and Contingencies San Diego Leases In April 2013, 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 assets on the condensed consolidated balance sheet related to the entire building 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 located in San Diego, California. The total space under the new Lease is approximately 51,000 square feet. The Company is using the facility for office, manufacturing and research and development purposes. The term 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. 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. As of March 31, 2018, the Company has capitalized $2.3 million of reimbursable tenant improvements to the new office which has been recorded as a leasehold improvement within fixed assets on the condensed consolidated balance sheet, offset by a corresponding amount recorded in deferred rent. Plymouth Meeting Lease In March 2014, the Company entered into a lease (the "Lease") for office space located in Plymouth Meeting, Pennsylvania. The Company occupied the space in June 2014. The initial term of the 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 of 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 recorded in deferred rent. The Company's future minimum lease payments under all non-cancelable operating leases as of March 31, 2018 are as follows:
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 our obligations and the unique facts and circumstances involved in each particular agreement. Historically, payments made by us under these types of agreements have not had a material effect on the Company's business, consolidated results of operations or financial condition. |
Collaborative Agreements |
3 Months Ended |
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Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Agreements | 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-front 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 for the three months ended March 31, 2018. The Company also incurred advisory fees of $960,000 in connection with receiving the up-front 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 for the three months 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 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 Company The Company identified the promised goods or services at the effective date of the ApolloBio agreement and determined that the license to VGX-3100 in the territories represents a distinct performance obligation on a standalone basis. The Company has determined that as of March 31, 2018, the performance obligation had not been satisfied, as the transfer of technology had not occurred. The Company has recorded the gross up-front payment received from ApolloBio of $23.0 million on the condensed consolidated balance sheet as deferred revenue as of March 31, 2018. MedImmune On August 7, 2015, the Company entered into a license and collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca. Under the agreement, MedImmune 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. MedImmune made an upfront payment of $27.5 million to the Company in September 2015 and has agreed to make potential future development and regulatory event-based payments totaling up to $355 million and potential future commercial event-based payments totaling up to $345 million, in each case upon the achievement of specified milestones set forth in the license and collaboration agreement. MedImmune will fund all development costs associated with INO-3112 immunotherapy. The Company is entitled to receive up to mid-single to double-digit tiered royalties on INO-3112 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, MedImmune 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. As of December 31, 2017, the Company has recognized all of the $27.5 million upfront payment as revenue, as all identified material performance obligations have been met with respect to that payment. In December 2017, the Company received and recognized as revenue a $7.0 million milestone payment from MedImmune triggered by MedImmune’s initiation of the Phase 2 portion of an ongoing clinical trial under the agreement. During the three months ended March 31, 2018 the Company recognized revenues of $1.3 million from MedImmune primarily for manufacturing services. As of March 31, 2018, the Company had deferred revenue and accounts receivable related to MedImmune of $1.2 million and $3.0 million, respectively. The deferred revenue relates to advanced payments made by the Company to a third party biologics manufacturer for which MedImmune is obligated to pay. Prior to January 1, 2018 the Company accounted for the arrangement under Topic 605, which resulted in revenue of $306,000 from MedImmune for the three months ended March 31, 2017. 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 months ended March 31, 2018 and 2017, the Company recognized revenues of $0 and $4.0 million from Roche, respectively. DARPA- Ebola In April 2015, the Company received a grant from the Defense Advanced Research Projects Agency ("DARPA") to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola. The consortium, led by 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 funding period is over two years and covers a base award of $19.6 million and an option award of $24.6 million, which was exercised in September 2015. The development proposal includes a second option of $11.1 million to support additional product supply and clinical development activities. The options are contingent upon the successful completion of certain pre-clinical development milestones. During the three months ending March 31, 2018, the Company received funding of $376,000 related to the DARPA grant and recorded it as contra-research and development expense. During the three months ending March 31, 2017, the Company recognized revenues of $5.0 million from DARPA related to the grant. As of March 31, 2018, the Company had a deferred grant funding and grant receivable balance of $111,000 and $2.0 million, respectively, related to the DARPA grant. |
Subsequent Events |
3 Months Ended |
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Mar. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On April 11, 2018, the Company announced that it has entered into agreements with the Coalition for Epidemic Preparedness Innovations ("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 unlock research and development potential 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 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 known as INO-4500 and its vaccine candidate for MERS will be known as INO-4700. |
Basis of Presentation (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 March 31, 2018 and the condensed consolidated statements of operations, condensed consolidated statements of comprehensive loss and the condensed consolidated statements of cash flows for the three months ended March 31, 2018 and 2017, 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 for the periods presented. The results of operations for the three months ended March 31, 2018 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2018, 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, 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. The balance sheet at December 31, 2017 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 March 31, 2018 through the date it filed these unaudited condensed consolidated financial statements with the SEC. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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Revenue Recognition | 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 recognize 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 assess 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) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Where a portion of non-refundable, up-front 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-alone 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-front 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. 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. |
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Valuation of Intangible Assets and Goodwill | Valuation of Intangible Assets and Goodwill Intangible assets are amortized over their estimated useful lives ranging from 2 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 March 31, 2018 and December 31, 2017, 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 $5.6 million and $6.0 million, respectively. The determination of the value of intangible assets requires management to make estimates and assumptions that affect the Company’s 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 March 31, 2018. 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, 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. |
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Research and Development Expense | 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. |
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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 months ended March 31, 2018, $2.2 million was recorded as contra-research and development expense which previously would have been recorded as grant revenue. The following table illustrates the impact that adopting Topic 606 has had on our reported results in the condensed consolidated statement of operations.
ASU No. 2016-01. In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities. 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 gain on investment in affiliated entity related to PLS of $982,000 on the condensed consolidated statement of operations for the three months ended March 31, 2018. 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:
ASU No. 2016-02. In February 2016, the FASB issued ASU No. 2016-02, Leases. Under 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, measured 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, with early adoption permitted. The Company is currently evaluating the impact of the application of this accounting standard update on its financial statements and related disclosures. The Company currently has three operating leases for its office and laboratory spaces in San Diego, California and Plymouth Meeting, Pennsylvania that are expected to be impacted by the standard and result in the present value of the future lease payment presented as right-to-use assets with a corresponding lease liability at the date of adoption. |
Impact of Recently Issued Accounting Standards (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The following table illustrates the impact that adopting Topic 606 has had on our reported results in the condensed consolidated statement of operations.
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:
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Revenue Recognition (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Contract with Customer, Asset and Liability | The following table summarizes changes in the Company’s contract assets and liabilities for the three months ended March 31, 2018:
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Summary of Revenue Recognized from Contracts |
Investments (Tables) |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of investments | The following is a summary of available-for-sale securities as of March 31, 2018 and December 31, 2017:
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Marketable Securities and Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financial assets and liabilities measured at fair value on a recurring basis | 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 March 31, 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 December 31, 2017:
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Assumptions used to estimate the fair values of the common stock warrants | The assumptions used to estimate the fair value of common stock warrants at March 31, 2018 are presented below:
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Changes in fair value of the financial liabilities | The following table presents the changes in fair value of the Company’s Level 3 financial liabilities for the three months ended March 31, 2018:
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Goodwill and Intangible Assets (Tables) |
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Summary of intangible assets by major asset class | The following sets forth the goodwill and intangible assets by major asset class:
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Stockholders' Equity (Tables) |
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Summary of common and preferred stock authorized, issued and outstanding | The following is a summary of the Company's authorized and issued common and preferred stock as of March 31, 2018 and December 31, 2017:
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Summary of warrants outstanding | The following table summarizes the warrants outstanding as of March 31, 2018 and December 31, 2017:
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Net Loss Per Share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Diluted Earnings Per Share | The following tables reconcile the components of the numerator and denominator included in the calculations of diluted net loss per share:
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | 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 months ended March 31, 2018 and 2017:
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Stock-Based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||
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Mar. 31, 2018 | |||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||
Schedule of weighted average assumptions | The weighted average assumptions used in the Black-Scholes model for option grants to employees and directors are presented below:
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Commitments and Contingencies (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||
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Mar. 31, 2018 | |||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Rental Payments for Operating Leases | The Company's future minimum lease payments under all non-cancelable operating leases as of March 31, 2018 are as follows:
|
Critical Accounting Policies (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Dec. 31, 2017 |
|
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, net | $ 5,605,667 | $ 6,009,729 |
Minimum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 2 years | |
Maximum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 18 years | |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 17 years | |
Patents | Minimum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 8 years | |
Patents | Maximum | ||
Finite-Lived Intangible Assets [Line Items] | ||
Useful life | 17 years |
Principles of Consolidation (Details) |
Mar. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Noncontrolling interest, ownership percentage by noncontrolling owners | 15.00% | 15.00% |
Impact of Recently Issued Accounting Standards - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Dec. 31, 2017 |
|
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Contra-research and development expense | $ 2,200,000 | |
Accounting Standards Update 2016-01 | Retained Earnings | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Cumulative effect | $ 231,366 | |
Accounting Standards Update 2016-01 | AOCI Attributable to Parent | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Cumulative effect | $ (231,366) | |
Plumbline Life Sciences | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Gain on investment in affiliated entities | $ 982,000 |
Impact of Recently Issued Accounting Standards - Cumulative Effect of ASU 2016-01 (Details) - USD ($) |
Mar. 31, 2018 |
Jan. 01, 2018 |
Dec. 31, 2017 |
---|---|---|---|
Equity [Abstract] | |||
Accumulated deficit | $ (555,475,779) | $ (523,124,951) | $ (523,356,317) |
Accumulated other comprehensive loss | $ (461,136) | (348,371) | $ (117,005) |
Accounting Standards Update 2016-01 | |||
Equity [Abstract] | |||
Accumulated deficit | 231,366 | ||
Accumulated other comprehensive loss | $ (231,366) |
Revenue Recognition - Summary of Changes in Contract Assets and Liabilities (Details) |
3 Months Ended |
---|---|
Mar. 31, 2018
USD ($)
| |
Contract liabilities | |
Deductions | $ (652,000) |
MedImmune | |
Contract assets | |
Balance at January 1, 2018 | 1,693,530 |
Additions | 1,339,961 |
Deductions | (3,750) |
Balance at March 31, 2018 | 3,029,741 |
Contract liabilities | |
Balance at January 1, 2018 | 1,145,500 |
Additions | 582,500 |
Deductions | (531,583) |
Balance at March 31, 2018 | 1,196,417 |
ApolloBio | |
Contract liabilities | |
Balance at January 1, 2018 | 0 |
Additions | 23,000,000 |
Deductions | 0 |
Balance at March 31, 2018 | 23,000,000 |
Other Counterparty | |
Contract liabilities | |
Balance at January 1, 2018 | 271,894 |
Additions | 0 |
Deductions | (120,534) |
Balance at March 31, 2018 | $ 151,360 |
Revenue Recognition - Narrative (Details) |
3 Months Ended |
---|---|
Mar. 31, 2018
USD ($)
| |
Disaggregation of Revenue [Line Items] | |
Revenue recognized from deferred revenue beginning balance | $ 652,000 |
MedImmune | |
Disaggregation of Revenue [Line Items] | |
Total revenue recognized | 1,300,000 |
Revenue recognized from deferred revenue beginning balance | 531,583 |
GeneOne | |
Disaggregation of Revenue [Line Items] | |
Total revenue recognized | 118,000 |
Other Counterparty | |
Disaggregation of Revenue [Line Items] | |
Total revenue recognized | 123,000 |
Revenue recognized from deferred revenue beginning balance | $ 120,534 |
Investments - Narrative (Details) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2018
USD ($)
investment
|
Mar. 31, 2017
USD ($)
|
|
Investments, Debt and Equity Securities [Abstract] | ||
Investment impairment charges | $ | $ 253 | $ 52 |
Number of securities in gross unrealized loss position | investment | 28 | |
Number of securities in gross unrealized loss position for longer than 12 months | investment | 3 | |
Total unrealized loss | $ | $ 28 |
Marketable Securities and Fair Value Measurements - Assumptions Used to Estimate Fair Value of Common Stock Warrants (Details) |
3 Months Ended |
---|---|
Mar. 31, 2018
$ / shares
| |
Fair Value Disclosures [Abstract] | |
Risk-free interest rate | 1.93% |
Expected volatility | 65.00% |
Expected life in years | 5 months 12 days |
Dividend yield (dollars per share) | $ 0 |
Marketable Securities and Fair Value Measurements - Changes of Fair Value of Level 3 Financial Liabilities (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Mar. 31, 2017 |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Increase attributable to change in fair value of common stock warrants | $ 128,000 | $ (116,000) |
Using Significant Unobservable Inputs (Level 3) | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at December 31, 2017 | 360,795 | |
Increase attributable to change in fair value of common stock warrants | 127,841 | |
Balance at March 31, 2018 | $ 488,636 |
Goodwill and Intangible Assets - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Mar. 31, 2017 |
|
Goodwill and Intangible Assets (Textual) [Abstract] | ||
Aggregate amortization expense on intangible assets | $ 404,062 | $ 406,299 |
Estimated aggregate amortization expense for remainder of 2018 | 846,000 | |
Estimated aggregate amortization expense for 2019 | 1,100,000 | |
Estimated aggregate amortization expense for 2020 | 547,000 | |
Estimated aggregate amortization expense for 2021 | 520,000 | |
Estimated aggregate amortization expense for 2022 | 493,000 | |
Estimated aggregate amortization expense for 2023 and the years after | $ 2,100,000 |
Stockholders' Equity - Summary of Authorized and Issued Common and Preferred Stock (Details) - $ / shares |
Mar. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Summary of common and preferred stock authorized, issued and outstanding | ||
Common stock, par value (dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares, authorized (shares) | 600,000,000 | |
Common stock, shares, issued (shares) | 90,704,931 | |
Common stock, shares, outstanding (shares) | 90,704,931 | 90,357,644 |
Series C Preferred Stock | ||
Summary of common and preferred stock authorized, issued and outstanding | ||
Preferred Stock, par value (dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (shares) | 1,091 | |
Preferred stock, shares issued (shares) | 1,091 | |
Preferred stock, shares outstanding (shares) | 23 | 23 |
Stockholders' Equity - Summary of Warrants Outstanding (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Dec. 31, 2017 |
|
Summary of warrants outstanding | ||
Number of Warrants Outstanding (shares) | 284,091 | 284,091 |
Common Stock Warrant Liability | $ 488,636 | $ 360,795 |
March 2013 financing | ||
Summary of warrants outstanding | ||
Exercise price (dollars per share) | $ 3.17 | |
Expiration Date | Sep. 12, 2018 | |
Number of Warrants Outstanding (shares) | 284,091 | 284,091 |
Common Stock Warrant Liability | $ 488,636 | $ 360,795 |
Net Loss Per Share - Schedule of Diluted Loss Per Share (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Mar. 31, 2017 |
|
Numerator | ||
Net loss | $ (32,350,828) | $ (23,085,907) |
Adjustment for decrease in fair value of warrant liability | 0 | (116,477) |
Numerator for use in diluted net loss per share | $ (32,350,828) | $ (23,202,384) |
Denominator | ||
Weighted average number of common shares outstanding (shares) | 90,451,791 | 74,152,609 |
Effect of dilutive potential common shares (shares) | 0 | 148,275 |
Denominator for use in diluted net loss per share (shares) | 90,451,791 | 74,300,884 |
Net loss per share, diluted (dollars per share) | $ (0.36) | $ (0.31) |
Net Loss Per Share - Schedule of Anti-Dilutive Securities (Details) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2018 |
Mar. 31, 2017 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded (shares) | 11,551,910 | 9,227,018 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded (shares) | 9,467,477 | 7,841,669 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded (shares) | 284,091 | 0 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded (shares) | 1,791,886 | 1,376,893 |
Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded (shares) | 8,456 | 8,456 |
Commitments and Contingencies - Summary of Future Minimum Lease Payments (Details) $ in Thousands |
Mar. 31, 2018
USD ($)
|
---|---|
Commitments and Contingencies Disclosure [Abstract] | |
Remainder of 2018 | $ 2,447 |
2019 | 3,756 |
2020 | 3,891 |
2021 | 3,979 |
2022 | 4,052 |
Thereafter | 19,975 |
Total | $ 38,100 |
Subsequent Events (Details) - Coalition for Epidemic Preparedness Innovations - Subsequent Event $ in Millions |
Apr. 11, 2018
USD ($)
|
---|---|
Subsequent Event [Line Items] | |
Collaborative agreement, funding to be received | $ 56 |
Collaborative agreement, period to receive funding for research and development | 5 years |
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