VICAL INC, 10-Q filed on 5/2/2019
Quarterly Report
v3.19.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2019
Apr. 22, 2019
Document And Entity Information [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Mar. 31, 2019  
Document Fiscal Year Focus 2019  
Document Fiscal Period Focus Q1  
Trading Symbol VICL  
Entity Registrant Name VICAL INC  
Entity Central Index Key 0000819050  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Entity Emerging Growth Company false  
Entity Small Business true  
Entity Common Stock, Shares Outstanding   22,822,716
v3.19.1
Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Current assets:    
Cash and cash equivalents $ 11,259 $ 11,870
Marketable securities, available-for-sale 34,272 36,201
Receivables and other assets 826 1,128
Total current assets 46,357 49,199
Long-term investments 0 2,386
Property and equipment, net 86 100
Other assets 0 659
Total assets 46,443 52,344
Current liabilities:    
Accounts payable and accrued expenses 2,521 3,551
Deferred revenue 0 30
Total current liabilities 2,521 3,581
Stockholders' equity:    
Preferred stock, $0.01 par value, 5,000 shares authorized, none issued and outstanding 0 0
Common stock, $0.01 par value, 50,000 shares authorized, 22,823 and 21,817 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively 229 218
Additional paid-in capital 490,318 490,337
Accumulated deficit (446,642) (442,064)
Accumulated other comprehensive income 17 272
Total stockholders' equity 43,922 48,763
Total liabilities and stockholders' equity $ 46,443 $ 52,344
v3.19.1
Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2019
Dec. 31, 2018
Statement Of Financial Position [Abstract]    
Preferred stock, par value $ 0.01 $ 0.01
Preferred stock, shares authorized 5,000,000 5,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.01 $ 0.01
Common stock, shares authorized 50,000,000 50,000,000
Common stock, shares issued 22,823,000 21,817,000
Common stock, shares outstanding 22,823,000 21,817,000
v3.19.1
Statements of Operations (Unaudited) - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Revenues:    
Contract revenue $ 0 $ 706
License and royalty revenue 0 10
Total revenues 0 716
Operating expenses:    
Research and development 3,882 3,664
Manufacturing and production 0 1,436
General and administrative 1,376 2,117
Total operating expenses 5,258 7,217
Loss from operations (5,258) (6,501)
Other income:    
Investment and other income, net 680 231
Net loss $ (4,578) $ (6,270)
Basic and diluted net loss per share $ (0.21) $ (0.29)
Weighted average shares used in computing basic and diluted net loss per share 21,998 21,828
v3.19.1
Statements of Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Statement Of Income And Comprehensive Income [Abstract]    
Net loss $ (4,578) $ (6,270)
Unrealized gain (loss) on available-for-sale and long-term marketable securities:    
Unrealized gain (loss) arising during holding period for three months ended March 31, 2019 and 2018, respectively 118 (65)
Less: Reclassification adjustment for gains included in net loss (373) 0
Other comprehensive loss (255) (65)
Total comprehensive loss $ (4,833) $ (6,335)
v3.19.1
Statements of Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Total
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Accumulated Other Comprehensive Income/(Loss) [Member]
Beginning Balance at Dec. 31, 2017 $ 63,577 $ 218 $ 489,975 $ (426,738) $ 122
Beginning Balance, shares at Dec. 31, 2017   21,802      
Net loss (6,270)     (6,270)  
Retained earnings adjustment upon adoption ofASU 2014-09 928     928  
Other comprehensive loss (65)       (65)
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes 1   1    
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes, shares   13      
Non-cash compensation expense related to grant of equity based compensation 47   47    
Ending Balance at Mar. 31, 2018 58,218 $ 218 490,023 (432,080) 57
Ending Balance, shares at Mar. 31, 2018   21,815      
Beginning Balance at Dec. 31, 2018 $ 48,763 $ 218 490,337 (442,064) 272
Beginning Balance, shares at Dec. 31, 2018 21,817 21,817      
Net loss $ (4,578)     (4,578)  
Other comprehensive loss (255)       (255)
Issuance of common stock upon exercise of warrants 10 $ 10      
Issuance of common stock upon exercise of warrants, shares   993      
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes 1 $ 1      
Issuance of common stock underlying restricted stock units net of shares withheld to settle withholding taxes, shares   13      
Non-cash compensation expense related to grant of equity based compensation (19)   (19)    
Ending Balance at Mar. 31, 2019 $ 43,922 $ 229 $ 490,318 $ (446,642) $ 17
Ending Balance, shares at Mar. 31, 2019 22,823 22,823      
v3.19.1
Statements of Cash Flows - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Cash flows from operating activities:    
Net loss $ (4,578) $ (6,270)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 13 64
Accretion of discount on short-term investments (116) (24)
Write-off of abandoned patents 0 267
Net gain on sale of long-term investment (373) 0
Compensation related to stock options and awards (19) 47
Changes in operating assets and liabilities:    
Receivables and other assets 961 3,679
Accounts payable and accrued expenses (1,928) (2,315)
Employee termination benefits accrual 898 168
Deferred revenue (30) (184)
Net cash used in operating activities (5,172) (4,568)
Cash flows from investing activities:    
Proceeds from the sale of long-term investment 2,469 0
Maturities of marketable securities 8,500 7,225
Purchases of marketable securities (6,419) (17,389)
Net cash provided by (used in) investing activities 4,550 (10,164)
Cash flows from financing activities:    
Net proceeds from issuance of common stock 11 1
Net cash provided by financing activities 11 1
Net decrease in cash, cash equivalents and restricted cash (611) (14,731)
Cash, cash equivalents and restricted cash at beginning of period 11,870 25,033
Cash, cash equivalents and restricted cash at end of period $ 11,259 $ 10,302
v3.19.1
Basis of Presentation
3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Basis of Presentation

1.

BASIS OF PRESENTATION

Vical Incorporated, or the Company, a Delaware corporation, was incorporated in April 1987 and has devoted substantially all of its resources since that time to the research and development of biopharmaceutical products, including those based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.

The unaudited financial statements at March 31, 2019, and for the three months ended March 31, 2019 and 2018, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or SEC, and with accounting principles generally accepted in the United States applicable to interim financial statements. These unaudited financial statements have been prepared on the same basis as the audited financial statements included in the Company’s Annual Report on Form 10-K and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results expected for a full year or future periods. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and 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 materially from those estimates. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2018, included in its Annual Report on Form 10-K filed with the SEC. 

Cash, Cash Equivalents and Marketable Securities

Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less and that can be liquidated without prior notice or penalty. Investments with an original maturity of more than ninety days are considered marketable securities and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities or the amounts, net of tax, reclassified out of accumulated other comprehensive income (loss), if any, are determined on a specific identification basis.

Revenue Recognition

The Company recognizes revenue when control of its products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development costs include salaries and personnel-related costs, supplies and materials, outside services, costs of conducting preclinical and clinical trials, facilities costs and amortization of intangible assets. The Company accounts for its clinical trial costs by estimating the total cost to treat a patient in each clinical trial, and accruing this total cost for the patient over the estimated treatment period, which corresponds with the period over which the services are performed, beginning when the patient enrolls in the clinical trial. This estimated cost includes payments to the site conducting the trial, and patient-related lab and other costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, the method of administration of the treatment, and the number of treatments that a patient receives. Treatment periods vary depending on the clinical trial. The Company makes revisions to the clinical trial cost estimates in the current period, as clinical trials progress.

Manufacturing and Production Costs

Manufacturing and production costs include expenses related to manufacturing contracts and expenses for the production of plasmid DNA for use in the Company’s research and development efforts. Production expenses related to the Company’s research and development efforts are expensed as incurred.

Net Loss Per Share

Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and warrants and any assumed issuance of common stock under restricted stock units (RSUs) as the effect would be antidilutive. Common stock equivalents of 7.0 million and 7.2 million shares for the three months ended March 31, 2019 and 2018, respectively, were excluded from the calculation because of their antidilutive effect.              

Stock-Based Compensation

The Company records its compensation expense associated with stock options and other forms of equity compensation based on their fair value at the date of grant using the Black-Scholes-Merton option pricing model. Stock-based compensation includes amortization related to stock option awards based on the estimated grant date fair value. Stock-based compensation expense related to stock options is recognized ratably over the vesting period of the option. In addition, the Company records expense related to RSUs granted based on the fair value of those awards on the grant date. The fair value related to the RSUs is amortized to expense over the vesting term of those awards. Forfeitures of stock options and RSUs are recognized as they occur.  

Stock-based compensation expense for a stock-based award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed.

Recent Accounting Pronouncements

    In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).”  The new standard requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months and requires both lessees and lessors to disclose certain key information about lease transactions.  The standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.  The Company adopted this standard during the first quarter of 2019.  The adoption of this guidance did not have a material impact on the Company’s financial statements and related disclosures.

 

v3.19.1
Stock-Based Compensation
3 Months Ended
Mar. 31, 2019
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]  
Stock-Based Compensation

2.

STOCK-BASED COMPENSATION

Total stock-based compensation expense was allocated to research and development, manufacturing and production and general and administrative expense as follows (in thousands):

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

Research and development

 

$

(50

)

 

$

28

 

Manufacturing and production

 

 

 

 

 

(68

)

General and administrative

 

 

31

 

 

 

87

 

Total stock-based compensation expense

 

$

(19

)

 

$

47

 

 

There were no stock-based awards granted by the Company during the three months ended March 31, 2019.  During the three months ended March 31, 2018, the Company granted stock-based awards with a total estimated value of $0.4 million, which were equal to 2.3% of the outstanding shares of common stock at the end of the period. At March 31, 2019, total unrecognized estimated compensation expense related to unvested stock-based awards granted prior to that date was $0.1 million, which is expected to be recognized over a weighted-average period of 1.4 years.   

v3.19.1
Marketable Securities, Available for Sale
3 Months Ended
Mar. 31, 2019
Investments Debt And Equity Securities [Abstract]  
Marketable Securities, Available for Sale

3.

MARKETABLE SECURITIES, AVAILABLE FOR SALE

The following is a summary of available-for-sale marketable securities (in thousands):

 

March 31, 2019

 

Amortized

Cost

 

 

Unrealized

Gain

 

 

Unrealized

Loss

 

 

Market

Value

 

U.S. treasuries

 

$

34,255

 

 

$

17

 

 

$

 

 

$

34,272

 

 

 

$

34,255

 

 

$

17

 

 

$

 

 

$

34,272

 

 

December 31, 2018

 

Amortized

Cost

 

 

Unrealized

Gain

 

 

Unrealized

Loss

 

 

Market

Value

 

U.S. treasuries

 

$

36,219

 

 

$

 

 

$

18

 

 

$

36,201

 

 

 

$

36,219

 

 

$

 

 

$

18

 

 

$

36,201

 

 

At March 31, 2019, none of these securities were scheduled to mature outside of one year. The Company did not realize any gains or losses on sales of available-for-sale securities for the three months ended March 31, 2019. As of March 31, 2019, none of the securities had been in a continuous material unrealized loss position longer than one year.

v3.19.1
Other Balance Sheet Accounts
3 Months Ended
Mar. 31, 2019
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Other Balance Sheet Accounts

4.

OTHER BALANCE SHEET ACCOUNTS

Accounts payable and accrued expenses consisted of the following (in thousands):

 

 

 

March 31,

 

 

December 31,

 

 

 

2019

 

 

2018

 

Employee compensation

 

$

548

 

 

$

1,768

 

Post-termination benefit accrual

 

 

898

 

 

 

 

Clinical trial accruals

 

 

158

 

 

 

1,000

 

Accounts payable

 

 

877

 

 

 

412

 

Other accrued liabilities

 

 

40

 

 

 

371

 

Total accounts payable and accrued expenses

 

$

2,521

 

 

$

3,551

 

v3.19.1
Long-Term Investments
3 Months Ended
Mar. 31, 2019
Investments All Other Investments [Abstract]  
Long-Term Investments

5.

LONG-TERM INVESTMENTS

During the three months ended March 31, 2019, the Company sold its auction rate security classified as a long-term investment with a par value of $2.5 million.   Included in investment and other income for the three months ended March 31, 2019 is a net gain of $0.4 million related to the sale.

v3.19.1
Fair Value Measurements
3 Months Ended
Mar. 31, 2019
Fair Value Disclosures [Abstract]  
Fair Value Measurements

6.

FAIR VALUE MEASUREMENTS

The Company measures fair value as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are based on a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1: Observable inputs such as quoted prices in active markets;

 

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

 

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.   

Cash equivalents, marketable securities and long-term investments measured at fair value are classified in the table below in one of the three categories described above (in thousands):

 

 

 

Fair Value Measurements

 

March 31, 2019

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market funds

 

$

10,613

 

 

$

 

 

$

 

 

$

10,613

 

U.S. treasuries

 

 

34,272

 

 

 

 

 

 

 

 

 

34,272

 

 

 

$

44,885

 

 

$

 

 

$

 

 

$

44,885

 

 

 

 

Fair Value Measurements

 

December 31, 2018

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market funds

 

$

11,523

 

 

$

 

 

$

 

 

$

11,523

 

U.S. treasuries

 

 

36,201

 

 

 

 

 

 

 

 

 

36,201

 

Auction rate securities

 

 

 

 

 

 

 

 

2,386

 

 

 

2,386

 

 

 

$

47,724

 

 

$

 

 

$

2,386

 

 

$

50,110

 

 

The Company’s investments in U.S. treasury securities, certificates of deposit and money market funds are valued based on publicly available quoted market prices for identical securities as of March 31, 2019. The Company determines the fair value of corporate bonds and other government-sponsored enterprise related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company validates the valuations received from its primary pricing vendors for its Level 2 securities by examining the inputs used in that vendor’s pricing process and determines whether they are reasonable and observable. The Company also compares those valuations to recent reported trades for those securities. As of March 31, 2019 and December 31, 2018, the Company had no investments in Level 2 securities. The Company did not transfer any investments between level categories during the three months ended March 31, 2019.

Activity for assets measured at fair value using significant unobservable inputs (Level 3) is presented in the table below (in thousands):

 

Balance at December 31, 2018

 

$

2,386

 

Change in fair market value included in other comprehensive loss

 

 

83

 

Sale of Level 3 security

 

 

(2,469

)

Balance at March 31, 2019

 

$

 

Total gains or losses for the period included in net loss attributable to the change in

   unrealized gains or losses relating to assets still held at the reporting date

 

$

 

v3.19.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2019
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7.

COMMITMENTS AND CONTINGENCIES

In the ordinary course of business, the Company may become a party to additional lawsuits involving various matters. The Company is unaware of any such lawsuits presently pending against it which, individually or in the aggregate, are deemed to be material to the Company’s financial condition or results of operations.

The Company prosecutes its intellectual property vigorously to obtain the broadest valid scope for its patents. Due to uncertainty of the ultimate outcome of these matters, the impact on future operating results or the Company’s financial condition is not subject to reasonable estimates.

v3.19.1
Astellas Out-License Agreements
3 Months Ended
Mar. 31, 2019
Astellas Out-License Agreements [Member]  
Astellas License Agreements

8.

ASTELLAS OUT-LICENSE AGREEMENTS

In July 2011, the Company entered into license agreements with Astellas Pharma Inc., or Astellas, related to the Company’s CMV program. The license agreement was terminated in February 2018. Under the terms of the agreements, the Company was performing research and development services and manufacturing services which were being paid for by Astellas. During the three months ended March 31, 2018, the Company recognized $0.5 million of revenue related to these contract services.

 

         

v3.19.1
Facility Lease
3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Facility Lease

9.

FACILITY LEASE

The Company occupies approximately 17,000 square feet of research laboratory and office space at a single site in San Diego, California under a sublease with Genopis, Inc., or Genopis.     In July 2018, the Company entered into an agreement with Genopis to sell the Company’s idle manufacturing assets for $1.7 million. As part of the agreement, Genopis agreed to sublease 51,400 square feet of the Company’s facility through the remaining term of the Company’s lease, which expired on December 31, 2018.  Genopis was also required to sign a long-term lease with the facility’s landlord beginning on January 1, 2019. Genopis agreed to sublease 17,000 square feet of the facility (consisting of lab and office space) to the Company at no cost for the one-year period ending on December 31, 2019.  The fair value of rent of the lab and office space that the Company is occupying at no cost was $0.6 million as of March 31, 2019 and is recorded in receivables and other assets.

 

v3.19.1
Stockholders' Equity
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Stockholders' Equity

10.

STOCKHOLDERS’ EQUITY      

As of the date of this filing, the Company has on file a shelf registration statement that allows it to raise up to an additional $40.0 million from the sale of common stock, preferred stock, debt securities and/or warrants, subject to limitations on the amount of securities that it may sell under the registration statement in any 12-month period. Specific terms of any offering under a shelf registration statement and the securities involved would be established at the time of sale.

In November 2017, the Company sold 9,194,286 shares of its common stock in a public offering at a price of $1.75 per share, including an overallotment of 2,142,857 shares issued at a price of $1.75 per share, and pre-funded warrants to purchase 7,234,285 shares of common stock at a purchase price of $1.74 per share.   The pre-funded warrants have an exercise price of $0.01 per share and may be exercised at any time.  In March 2019, 993,211 warrants were exercised. As of March 31, 2019, warrants to purchase 6,241,074 shares of common stock were outstanding.

 

v3.19.1
Related Party Transaction
3 Months Ended
Mar. 31, 2019
Related Party Transactions [Abstract]  
Related Party Transaction

11.

RELATED PARTY TRANSACTION

On April 4, 2017, the Company entered into a research collaboration agreement with AnGes. As of the date of the transaction, AnGes held 18.6% of the outstanding stock of the Company. Pursuant to the collaboration agreement, AnGes agreed to make a non-refundable payment to the Company of $750,000 and the Company agreed to conduct certain research activities related to a development program targeting chronic hepatitis B. An amendment to the agreement was executed in September 2018 that added an additional non-refundable payment from AnGes to the Company of $145,000.  The HBV program was cancelled in 2019. As of March 31, 2019, the Company had recognized the full $895,000 as contract revenue.

v3.19.1
Restructuring Costs
3 Months Ended
Mar. 31, 2019
Restructuring And Related Activities [Abstract]  
Restructuring Costs

12.

RESTRUCTURING COSTS

In February 2019, the Company made the decision to discontinue the Phase 2 clinical trial of VL-2397.  As a result, the Company restructured its operations to conserve capital and recorded a restructuring charge of $1.5 million during the three months ended March 31, 2019.

In January 2018, the Company and Astellas announced that ASP0113 did not meet its primary endpoint in a Phase 3 clinical study in CMV end organ disease, after which Astellas informed the Company that it was terminating further development.  As a result, the Company restructured its operations to conserve capital, which included a staff reduction of 40 employees and the write-off of certain intangible assets. The Company recorded charges for one-time employee termination benefits of $1.1 million and for intangible asset impairments of $0.3 million during the three months ended March 31, 2018.  Overhead costs associated with the former manufacturing facility of 0.2 million were recognized as general and administrative expense during the three months ended March 31, 2018.

The following table summarizes the restructuring charges (in thousands) recorded for the three months ended March 31, 2019 and 2018:

 

 

 

Employee

 

 

 

 

 

 

 

 

 

 

 

Termination

 

 

Asset

 

 

 

 

 

2019

 

Benefits

 

 

Impairments

 

 

Total

 

Research and development

 

$

1,491

 

 

$

 

 

$

1,491

 

General and administrative

 

 

26

 

 

 

 

 

 

26

 

 

 

$

1,517

 

 

$

 

 

$

1,517

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

 

 

 

 

 

 

 

 

 

 

Termination

 

 

Asset

 

 

 

 

 

2018

 

Benefits

 

 

Impairments

 

 

Total

 

Research and development

 

$

272

 

 

$

267

 

 

$

539

 

Manufacturing and production

 

 

735

 

 

 

 

 

 

735

 

General and administrative

 

 

117

 

 

 

 

 

 

117

 

 

 

$

1,124

 

 

$

267

 

 

$

1,391

 

 

 

The following table sets forth the accrual activity for employee termination benefits for the three months ended March 31, 2019 (in thousands).

 

 

 

 

 

 

Balance at December 31, 2018

 

$

 

     Accruals

 

 

1,517

 

     Payments

 

 

(619

)

Balance at March 31, 2019

 

$

898

 

 

v3.19.1
Basis of Presentation (Policies)
3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Cash, Cash Equivalents and Marketable Securities

Cash, Cash Equivalents and Marketable Securities

Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less and that can be liquidated without prior notice or penalty. Investments with an original maturity of more than ninety days are considered marketable securities and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities or the amounts, net of tax, reclassified out of accumulated other comprehensive income (loss), if any, are determined on a specific identification basis.

Revenue Recognition

Revenue Recognition

The Company recognizes revenue when control of its products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control.

Research and Development Costs

Research and Development Costs

Research and development costs are expensed as incurred. Research and development costs include salaries and personnel-related costs, supplies and materials, outside services, costs of conducting preclinical and clinical trials, facilities costs and amortization of intangible assets. The Company accounts for its clinical trial costs by estimating the total cost to treat a patient in each clinical trial, and accruing this total cost for the patient over the estimated treatment period, which corresponds with the period over which the services are performed, beginning when the patient enrolls in the clinical trial. This estimated cost includes payments to the site conducting the trial, and patient-related lab and other costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, the method of administration of the treatment, and the number of treatments that a patient receives. Treatment periods vary depending on the clinical trial. The Company makes revisions to the clinical trial cost estimates in the current period, as clinical trials progress.

Manufacturing and Production Costs

Manufacturing and Production Costs

Manufacturing and production costs include expenses related to manufacturing contracts and expenses for the production of plasmid DNA for use in the Company’s research and development efforts. Production expenses related to the Company’s research and development efforts are expensed as incurred.

Net Loss Per Share

Net Loss Per Share

Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and warrants and any assumed issuance of common stock under restricted stock units (RSUs) as the effect would be antidilutive. Common stock equivalents of 7.0 million and 7.2 million shares for the three months ended March 31, 2019 and 2018, respectively, were excluded from the calculation because of their antidilutive effect.              

Stock-Based Compensation

Stock-Based Compensation

The Company records its compensation expense associated with stock options and other forms of equity compensation based on their fair value at the date of grant using the Black-Scholes-Merton option pricing model. Stock-based compensation includes amortization related to stock option awards based on the estimated grant date fair value. Stock-based compensation expense related to stock options is recognized ratably over the vesting period of the option. In addition, the Company records expense related to RSUs granted based on the fair value of those awards on the grant date. The fair value related to the RSUs is amortized to expense over the vesting term of those awards. Forfeitures of stock options and RSUs are recognized as they occur.  

Stock-based compensation expense for a stock-based award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

    In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).”  The new standard requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months and requires both lessees and lessors to disclose certain key information about lease transactions.  The standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.  The Company adopted this standard during the first quarter of 2019.  The adoption of this guidance did not have a material impact on the Company’s financial statements and related disclosures.

 

v3.19.1
Stock-Based Compensation (Tables)
3 Months Ended
Mar. 31, 2019
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]  
Summary of Total Stock-Based Compensation Expense

Total stock-based compensation expense was allocated to research and development, manufacturing and production and general and administrative expense as follows (in thousands):

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

Research and development

 

$

(50

)

 

$

28

 

Manufacturing and production

 

 

 

 

 

(68

)

General and administrative

 

 

31

 

 

 

87

 

Total stock-based compensation expense

 

$

(19

)

 

$

47

 

v3.19.1
Marketable Securities, Available for Sale (Tables)
3 Months Ended
Mar. 31, 2019
Investments Debt And Equity Securities [Abstract]  
Summary of Available-for-Sale Marketable Securities

The following is a summary of available-for-sale marketable securities (in thousands):

 

March 31, 2019

 

Amortized

Cost

 

 

Unrealized

Gain

 

 

Unrealized

Loss

 

 

Market

Value

 

U.S. treasuries

 

$

34,255

 

 

$

17

 

 

$

 

 

$

34,272

 

 

 

$

34,255

 

 

$

17

 

 

$

 

 

$

34,272

 

 

December 31, 2018

 

Amortized

Cost

 

 

Unrealized

Gain

 

 

Unrealized

Loss

 

 

Market

Value

 

U.S. treasuries

 

$

36,219

 

 

$

 

 

$

18

 

 

$

36,201

 

 

 

$

36,219

 

 

$

 

 

$

18

 

 

$

36,201

 

v3.19.1
Other Balance Sheet Accounts (Tables)
3 Months Ended
Mar. 31, 2019
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Summary of Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following (in thousands):

 

 

 

March 31,

 

 

December 31,

 

 

 

2019

 

 

2018

 

Employee compensation

 

$

548

 

 

$

1,768

 

Post-termination benefit accrual

 

 

898

 

 

 

 

Clinical trial accruals

 

 

158

 

 

 

1,000

 

Accounts payable

 

 

877

 

 

 

412

 

Other accrued liabilities

 

 

40

 

 

 

371

 

Total accounts payable and accrued expenses

 

$

2,521

 

 

$

3,551

 

v3.19.1
Fair Value Measurements (Tables)
3 Months Ended
Mar. 31, 2019
Fair Value Disclosures [Abstract]  
Summary of Cash Equivalents, Marketable Securities and Long-Term Investments Measured at Fair Value

Cash equivalents, marketable securities and long-term investments measured at fair value are classified in the table below in one of the three categories described above (in thousands):

 

 

 

Fair Value Measurements

 

March 31, 2019

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market funds

 

$

10,613

 

 

$

 

 

$

 

 

$

10,613

 

U.S. treasuries

 

 

34,272

 

 

 

 

 

 

 

 

 

34,272

 

 

 

$

44,885

 

 

$

 

 

$

 

 

$

44,885

 

 

 

 

Fair Value Measurements

 

December 31, 2018

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market funds

 

$

11,523

 

 

$

 

 

$

 

 

$

11,523

 

U.S. treasuries

 

 

36,201

 

 

 

 

 

 

 

 

 

36,201

 

Auction rate securities

 

 

 

 

 

 

 

 

2,386

 

 

 

2,386

 

 

 

$

47,724

 

 

$

 

 

$

2,386

 

 

$

50,110

 

Summary of Activity for Assets Measured at Fair Value Using Significant Unobservable Inputs

Activity for assets measured at fair value using significant unobservable inputs (Level 3) is presented in the table below (in thousands):

 

Balance at December 31, 2018

 

$

2,386

 

Change in fair market value included in other comprehensive loss

 

 

83

 

Sale of Level 3 security

 

 

(2,469

)

Balance at March 31, 2019

 

$

 

Total gains or losses for the period included in net loss attributable to the change in

   unrealized gains or losses relating to assets still held at the reporting date

 

$

 

v3.19.1
Restructuring Costs (Tables)
3 Months Ended
Mar. 31, 2019
Restructuring And Related Activities [Abstract]  
Summary of Restructuring Charges The following table summarizes the restructuring charges (in thousands) recorded for the three months ended March 31, 2019 and 2018:

 

 

Employee

 

 

 

 

 

 

 

 

 

 

 

Termination

 

 

Asset

 

 

 

 

 

2019

 

Benefits

 

 

Impairments

 

 

Total

 

Research and development

 

$

1,491

 

 

$

 

 

$

1,491

 

General and administrative

 

 

26

 

 

 

 

 

 

26

 

 

 

$

1,517

 

 

$

 

 

$

1,517

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

 

 

 

 

 

 

 

 

 

 

Termination

 

 

Asset

 

 

 

 

 

2018

 

Benefits

 

 

Impairments

 

 

Total

 

Research and development

 

$

272

 

 

$

267

 

 

$

539

 

Manufacturing and production

 

 

735

 

 

 

 

 

 

735

 

General and administrative

 

 

117

 

 

 

 

 

 

117

 

 

 

$

1,124

 

 

$

267

 

 

$

1,391

 

 

Schedule of Accrual Activity for Employee Termination Benefits

 

The following table sets forth the accrual activity for employee termination benefits for the three months ended March 31, 2019 (in thousands).

 

 

 

 

 

 

Balance at December 31, 2018

 

$

 

     Accruals

 

 

1,517

 

     Payments

 

 

(619

)

Balance at March 31, 2019

 

$

898

 

 

v3.19.1
Basis of Presentation - Additional Information (Detail) - shares
shares in Millions
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Organization Consolidation And Presentation Of Financial Statements [Abstract]    
Maximum period for cash and highly liquid securities with original maturities 90 days or less  
Minimum period for marketable securities classified as available-for-sale with original maturities More than 90 days  
Common stock equivalents excluded from the calculation of diluted net income per share 7.0 7.2
v3.19.1
Stock-Based Compensation - Summary of Total Stock-Based Compensation Expense (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Total stock-based compensation expense $ (19) $ 47
Research and development [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Total stock-based compensation expense (50) 28
Manufacturing and production [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Total stock-based compensation expense 0 (68)
General and administrative [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Total stock-based compensation expense $ 31 $ 87
v3.19.1
Stock-Based Compensation - Additional Information (Detail) - USD ($)
$ in Millions
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]    
Stock-based awards granted 0  
Estimated value of stock-based awards, granted   $ 0.4
Unrecognized compensation cost related to unvested options $ 0.1  
Unvested stock-based awards expected to be recognized, weighted-average period 1 year 4 months 24 days  
Portion of stock-based awards granted from outstanding common shares   2.30%
v3.19.1
Marketable Securities, Available for Sale - Summary of Available-for-Sale Marketable Securities (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Schedule of Available-for-sale Securities [Line Items]    
Amortized Cost $ 34,255 $ 36,219
Unrealized Gain 17 0
Unrealized Loss 0 18
Market Value 34,272 36,201
U.S. treasuries [Member]    
Schedule of Available-for-sale Securities [Line Items]    
Amortized Cost 34,255 36,219
Unrealized Gain 17 0
Unrealized Loss 0 18
Market Value $ 34,272 $ 36,201
v3.19.1
Marketable Securities, Available for Sale - Additional Information (Detail)
3 Months Ended
Mar. 31, 2019
USD ($)
Investments Debt And Equity Securities [Abstract]  
Available-for-sale securities maturing outside of one year $ 0
Realized gains or losses on sales of available-for-sale securities 0
Available-for-sale securities in a continuous material unrealized loss position longer than one year $ 0
v3.19.1
Other Balance Sheet Accounts - Summary of Accounts Payable and Accrued Expenses (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Payables And Accruals [Abstract]    
Employee compensation $ 548 $ 1,768
Post-termination benefit accrual 898 0
Clinical trial accruals 158 1,000
Accounts payable 877 412
Other accrued liabilities 40 371
Total accounts payable and accrued expenses $ 2,521 $ 3,551
v3.19.1
Long-Term Investments - Additional Information (Detail)
$ in Millions
3 Months Ended
Mar. 31, 2019
USD ($)
Investment [Line Items]  
Auction rate securities held, at par value $ 2.5
Investment and other income [Member]  
Investment [Line Items]  
Gain on sale $ 0.4
v3.19.1
Fair Value Measurements - Summary of Cash Equivalents, Marketable Securities and Long-Term Investments Measured at Fair Value (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value $ 44,885 $ 50,110
Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 44,885 47,724
Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 0 0
Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 0 2,386
Money market funds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 10,613 11,523
Money market funds [Member] | Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 10,613 11,523
Money market funds [Member] | Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 0 0
Money market funds [Member] | Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 0 0
U.S. treasuries [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 34,272 36,201
U.S. treasuries [Member] | Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 34,272 36,201
U.S. treasuries [Member] | Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value 0 0
U.S. treasuries [Member] | Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value $ 0 0
Auction rate securities [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value   2,386
Auction rate securities [Member] | Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value   0
Auction rate securities [Member] | Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value   0
Auction rate securities [Member] | Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair Value   $ 2,386
v3.19.1
Fair Value Measurements - Additional Information (Detail) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Level 2 [Member]    
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]    
Investments $ 0 $ 0
v3.19.1
Fair Value Measurements - Summary of Activity for Assets Measured at Fair Value Using Significant Unobservable Inputs (Detail)
$ in Thousands
3 Months Ended
Mar. 31, 2019
USD ($)
Fair Value Disclosures [Abstract]  
Balance at December 31, 2018 $ 2,386
Change in fair market value included in other comprehensive loss 83
Sale of Level 3 security (2,469)
Balance at March 31, 2019 0
Total gains or losses for the period included in net loss attributable to the change in unrealized gains or losses relating to assets still held at the reporting date $ 0
v3.19.1
Astellas Out-License Agreements - Additional Information (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]    
Revenue recognized $ 0 $ 706
Collaborative Arrangement [Member] | Astellas Out-License Agreements [Member] | Contract Services [Member]    
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]    
Revenue recognized   $ 500
v3.19.1
Facility Lease - Additional Information (Detail)
1 Months Ended
Jul. 31, 2018
USD ($)
ft²
Mar. 31, 2019
USD ($)
Dec. 31, 2018
USD ($)
Dec. 31, 2017
ft²
Facility Lease [Line Items]        
Receivables and other assets   $ 826,000 $ 1,128,000  
Receivables and Other Assets [Member]        
Facility Lease [Line Items]        
Receivables and other assets   $ 600,000    
Genopis Inc [Member]        
Facility Lease [Line Items]        
Sale of idle manufacturing assets $ 1,700,000      
Genopis Inc [Member] | California [Member]        
Facility Lease [Line Items]        
Area for leasing facility of research laboratory and office space | ft²       17,000
Genopis Inc [Member] | Period Through December 31, 2018 [Member]        
Facility Lease [Line Items]        
Renewal lease agreement expiry date Dec. 31, 2018      
Area of square feet agreed to sublease of facility | ft² 51,400      
Genopis Inc [Member] | Period Ending December 31, 2019 [Member]        
Facility Lease [Line Items]        
Area of square feet agreed to sublease of facility | ft² 17,000      
Long-term lease beginning date Jan. 01, 2019      
Facility lease cost $ 0      
Facility sublease expiration period 1 year      
Sublease expiration date Dec. 31, 2019