The accompanying notes are an integral part of these condensed financial statements.
The accompanying notes are an integral part of these condensed financial statements.
The accompanying notes are an integral part of these condensed financial statements.
The accompanying notes are an integral part of these condensed financial statements.
The accompanying notes are an integral part of these condensed financial statements.
Notes to Unaudited Condensed Financial Statements
Note 1. Organization
Description of Business
Cortexyme, Inc. (the “Company”) was incorporated in the State of Delaware in June 2012 and is headquartered in South San Francisco, California. The Company is a clinical stage biopharmaceutical company focused on developing therapeutics based on data supporting a new theory of the cause of Alzheimer’s disease and other degenerative disorders. Cortexyme is targeting a specific, infectious pathogen tied to neurodegeneration and chronic inflammation in humans and animal models.
Reverse Stock Split
On April 25, 2019, the Company’s Board of Directors approved a one-for-0.367647 reverse split of the Company’s issued and outstanding common stock, redeemable convertible preferred stock, and stock options. The par value of the common stock was not adjusted as a result of the reverse stock split. All share and per share amounts in the accompanying unaudited condensed financial statements and notes to the unaudited condensed financial statements have been retroactively adjusted for all periods presented to reflect the reverse stock split.
Initial Public Offering
On May 8, 2019, the Company’s registration statement on Form S-1 (File No. 333-230853) for its initial public offering of common stock (“IPO”) was declared effective by the Securities and Exchange Commission (“SEC”). On May 13, 2019, the Company closed its IPO with the sale of 5,073,800 shares of common stock, which included 661,800 shares of common stock issued upon the exercise in full of the underwriters’ option to purchase additional shares, at a public offering price of $17.00 per share, resulting in net proceeds of $77.8 million, after deducting underwriting discounts and commissions and estimated offering expenses paid by the Company.
In addition, in connection with the closing of the IPO, all of the Company’s outstanding shares of redeemable convertible preferred stock were automatically converted into 18,161,027 shares of common stock, and there are no shares of redeemable convertible preferred stock outstanding.
Private Investment in Public Equity (“PIPE”)
In February 2020, the Company completed a private investment in public equity transaction (“PIPE Financing”). The Company entered into Stock Purchase Agreements (the “Purchase Agreements”) with certain accredited investors, including an entity affiliated with a member of the Company’s Board of Directors, pursuant to which the Company sold and issued shares of common stock for aggregate gross proceeds of $125.0 million. Costs related to the offering were $7.4 million. Pursuant to the Purchase Agreements, the Company sold 2,500,000 common shares at $50.00 per common share. In connection with the PIPE Financing, the Company filed a registration statement on Form S-1 (File No. 333-237594), with the SEC registering for resale the shares of common stock issued in the PIPE Financing. The registration statement was declared effective by the SEC on April 13, 2020.
Liquidity and Capital Resources
The Company has incurred losses and negative cash flows from operations since inception and expects to continue to generate operating losses for the foreseeable future. As of June 30, 2020, the Company had an accumulated deficit of $104.6 million. Since inception through June 30, 2020, the Company has funded operations primarily with the net proceeds from the issuance of convertible promissory notes, from the issuance of redeemable convertible preferred stock, from the net proceeds from the IPO and from the net proceeds from the PIPE Financing. As of June 30,2020, the Company had cash, cash equivalents, and short-term investments of $144.5 million, which it believes will be sufficient to fund its planned operations for a period of at least 12 months from the date of the issuance of the accompanying unaudited financial statements. The Company also has long-term investments of $66.1 million.
Management expects to incur additional losses in the future to fund its operations and conduct product research and development and may need to raise additional capital to fully implement its business plan. The Company may raise additional capital through the issuance of equity securities, debt financings or other sources in order to further implement its business plan. However, if such financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of its product candidate.
6
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the instructions of the SEC on Form 10-Q and Article 10 of Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included.
The condensed balance sheet as of June 30, 2020, the condensed statements of operations and comprehensive loss for the three and six months ended June 30, 2020 and 2019, the condensed statements of redeemable convertible preferred stock and stockholders’ equity for the three and six months ended June 30, 2020 and 2019, the condensed statements of cash flows for the six months ended June 30, 2020 and 2019, and the financial data and other financial information disclosed in the notes to the condensed financial statements are unaudited. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2019 included in the Company’s Form 10-K filed with the SEC on March 16, 2020. The results of operations for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, or for any other future annual or interim period.
Risks and Uncertainties
The pandemic caused by an outbreak of a new strain of coronavirus, COVID-19, has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. The Company is actively monitoring the impact of COVID-19 and the possible effects on its financial condition, liquidity, operations, clinical trials, suppliers, industry and workforce. However, the full extent, consequences, and duration of the COVID-19 pandemic and the resulting impact on the Company cannot currently be predicted. The Company will continue to evaluate the impact that these events could have on the Company’s operations, financial position, and the results of operations and cash flows during fiscal year 2020.
Use of Estimates
The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and expenses, as well as related disclosure of contingent assets and liabilities. The most significant estimates used in the Company’s financial statements relate to the determination of the fair value of common stock prior to the initial public offering, stock-based awards and other issuances, accruals for research and development costs, useful lives of long-lived assets, stock-based compensation and related assumptions, the incremental borrowing rate for leases and income tax uncertainties, including a valuation allowance for deferred tax assets; and contingencies. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from the Company’s estimates.
Significant Accounting Policies
There have been no significant changes to the accounting policies during the six months ended June 30, 2020, as compared to the significant accounting policies described in our Annual Report on Form 10-K.
Cash, Cash Equivalents, and Restricted Cash
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the periods presented.
7
Fair Value Measurements
The fair value of our financial instruments reflects the amounts that we estimate we would receive in connection with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We disclose and recognize the fair value of our assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date;
Level 2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active;
Level 3 - Inputs that are unobservable. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
Our assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period.
Leases
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted the standard effective January 1, 2019.
The Company determines if an arrangement includes a lease at inception. Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The right-of-use asset includes any lease payments made and excludes lease incentives. Incremental borrowing rate is used in determining the present value of future payments. The Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The lease terms may include options to extend or terminate the lease. Lease expense for minimum lease payments is recognized on a straight-line basis over the non-cancelable lease term. The Company has elected not to recognize a right-of-use asset and lease liability for short-term leases. A short-term lease is a lease with an expected lease term of 12 months or less and which does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company also elected the package of practical expedients under the transition guidance that will retain the historical lease classification and initial direct costs for any leases that exist prior to adoption of the new guidance and the practical expedient to not separate lease and non-lease components. See Note 6 for further disclosure.
Finance lease right of use assets are recorded on the balance sheet in Property and equipment, net. The current portion of the operating lease liability is recorded in accrued expenses and other current liabilities.
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to not use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies.
Recent Accounting Pronouncements Adopted
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. The new guidance changes disclosure requirements related to fair value measurements as part of the disclosure framework project. The disclosure framework project aims to improve the effectiveness of disclosures in the notes to the financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The Company adopted this effective January 1, 2020. The adoption of this pronouncement did not have a material impact on its financial statements or disclosures.
8
In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40)”: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”), which clarifies the accounting for implementation costs in cloud computing arrangements. The Company adopted the standard prospectively on January 1, 2020. The adoption of this pronouncement did not have a material impact on its financial statements.
Recent Accounting Pronouncements Not Yet Adopted
The following are new accounting pronouncements that the Company is evaluating for future impacts on its financial statements:
Financial Instruments—Credit Losses: In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments which amends the principles around the recognition of credit losses by mandating entities incorporate an estimate of current expected credit losses when determining the value of certain assets. The guidance also amends reporting around allowances for credit losses on available-for-sale marketable securities. For Smaller Reporting Companies as defined by the SEC, ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is evaluating the impact of the guidance on its financial statements.
All other newly issued accounting pronouncements not yet effective have been deemed either immaterial or not applicable.
Note 3. Fair Value Measurements
The Company measures and reports its cash equivalents, restricted cash, and investments at fair value.
Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1. Investments are measured at fair value based on inputs other than quoted prices that are derived from observable market data and are classified as Level 2 inputs.
Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of June 30, 2020 and December 31, 2019 are presented in the following tables (in thousands):
|
|
Fair Value Measurements at June 30, 2020
|
|
|
|
Total
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Money market funds
|
|
$
|
62,568
|
|
|
$
|
62,568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Certificates of deposit
|
|
|
49,684
|
|
|
|
—
|
|
|
|
49,684
|
|
|
|
—
|
|
Municipal notes
|
|
|
214
|
|
|
|
—
|
|
|
|
214
|
|
|
|
—
|
|
Corporate notes
|
|
|
89,187
|
|
|
|
—
|
|
|
|
89,187
|
|
|
|
—
|
|
Government and agency notes
|
|
|
6,205
|
|
|
|
—
|
|
|
|
6,205
|
|
|
|
—
|
|
Total
|
|
$
|
207,858
|
|
|
$
|
62,568
|
|
|
$
|
145,290
|
|
|
$
|
—
|
|
|
|
Fair Value Measurements at December 31, 2019
|
|
|
|
Total
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Money market funds
|
|
$
|
30,054
|
|
|
$
|
30,054
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Certificates of deposit
|
|
|
20,046
|
|
|
|
—
|
|
|
|
20,046
|
|
|
|
—
|
|
Repurchase agreements
|
|
|
15,000
|
|
|
|
—
|
|
|
|
15,000
|
|
|
|
—
|
|
Corporate notes
|
|
|
38,783
|
|
|
|
—
|
|
|
|
38,783
|
|
|
|
—
|
|
Government notes
|
|
|
7,574
|
|
|
|
—
|
|
|
|
7,574
|
|
|
|
—
|
|
Commercial paper
|
|
|
1,096
|
|
|
|
—
|
|
|
|
1,096
|
|
|
|
—
|
|
Total
|
|
$
|
112,553
|
|
|
$
|
30,054
|
|
|
$
|
82,499
|
|
|
$
|
—
|
|
9
The following table summarizes the available-for-sale securities (in thousands):
|
|
Fair Value Measurements at June 30, 2020
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Fair Value
|
|
Money market funds
|
|
$
|
62,568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
62,568
|
|
Certificates of deposit
|
|
|
49,331
|
|
|
|
353
|
|
|
|
—
|
|
|
|
49,684
|
|
Municipal notes
|
|
|
213
|
|
|
|
1
|
|
|
|
—
|
|
|
|
214
|
|
Corporate notes
|
|
|
88,844
|
|
|
|
354
|
|
|
|
(11
|
)
|
|
|
89,187
|
|
Government and agency notes
|
|
|
6,191
|
|
|
|
23
|
|
|
|
(9
|
)
|
|
|
6,205
|
|
Total cash equivalents and investments
|
|
$
|
207,147
|
|
|
$
|
731
|
|
|
$
|
(20
|
)
|
|
$
|
207,858
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents (maturities within 90 days)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
63,403
|
|
Short-term investments (maturities within
one year)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
78,348
|
|
Long-term investments (maturities beyond
1 year)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66,107
|
|
Total cash equivalents and investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
207,858
|
|
|
|
Fair Value Measurements at December 31, 2019
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Fair Value
|
|
Money market funds
|
|
$
|
30,054
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,054
|
|
Certificates of deposit
|
|
|
19,992
|
|
|
|
54
|
|
|
|
—
|
|
|
|
20,046
|
|
Repurchase agreements
|
|
|
15,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
15,000
|
|
Corporate notes
|
|
|
38,788
|
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
38,783
|
|
Government notes
|
|
|
7,563
|
|
|
|
11
|
|
|
|
|
|
|
|
7,574
|
|
Commercial paper
|
|
|
1,096
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,096
|
|
Total cash equivalents and investments
|
|
$
|
112,493
|
|
|
$
|
65
|
|
|
$
|
(5
|
)
|
|
$
|
112,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents (maturities within 90 days)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
47,140
|
|
Short-term investments (maturities within
one year)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,650
|
|
Long-term investments (maturities beyond
1 year)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,763
|
|
Total cash equivalents and investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
112,553
|
|
As of June 30, 2020, the weighted average remaining contractual maturities of available-for-sale securities was approximately 11 months. There have been no significant realized losses on available-for-sale securities for the period presented. Based on the Company’s review of its available-for-sale securities, the Company has a limited number of available-for-sale securities in insignificant loss positions as of June 30, 2020, none of which have been in a loss position for more than one year. The Company believes it had no other-than-temporary impairments on these securities as of June 30, 2020, because the Company does not intend to sell these securities nor does the Company believe that it will be required to sell these securities before the recovery of their amortized cost basis.
The investments are classified as available-for-sale securities. At June 30, 2020 and December 31, 2019, the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities for the three or six months ended June 30, 2020 and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the quarter.
There were no transfers between Levels 1, 2 or 3 for the period presented.
10
Note 4: Cash, cash equivalents and investments
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed balance sheets that sum to the total of the same amounts shown in the condensed statements of cash flows (in thousands):
|
|
Six Months Ended June 30,
|
|
|
|
2020
|
|
|
2019
|
|
Cash and cash equivalents
|
|
$
|
66,156
|
|
|
$
|
44,314
|
|
Restricted cash
|
|
|
—
|
|
|
|
250
|
|
Total cash, cash equivalents and restricted cash
|
|
$
|
66,156
|
|
|
$
|
44,564
|
|
Restricted cash as of June 30, 2019 relates to a compensating balance to secure a credit card facility. There was no restricted cash as of June 30, 2020.
The following tables categorize the fair values of cash, cash equivalents, and short-term investments measured at fair value on a recurring basis on our balance sheet (in thousands):
|
|
June 30, 2020
|
|
|
December 31, 2019
|
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
2,753
|
|
|
$
|
4,074
|
|
Money market funds
|
|
|
62,568
|
|
|
|
30,054
|
|
Repurchase agreements
|
|
|
—
|
|
|
|
15,000
|
|
Certificates of deposit
|
|
|
735
|
|
|
|
985
|
|
Corporate notes
|
|
|
100
|
|
|
|
1,101
|
|
Total cash and cash equivalents
|
|
$
|
66,156
|
|
|
$
|
51,214
|
|
|
|
|
|
|
|
|
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
Commercial paper
|
|
$
|
—
|
|
|
$
|
1,096
|
|
Certificates of deposit
|
|
|
37,671
|
|
|
|
15,428
|
|
Municipal notes
|
|
|
214
|
|
|
|
—
|
|
Corporate notes
|
|
|
39,175
|
|
|
|
24,552
|
|
Government and agency notes
|
|
|
1,288
|
|
|
|
7,574
|
|
Total short-term investments
|
|
$
|
78,348
|
|
|
$
|
48,650
|
|
|
|
|
|
|
|
|
|
|
Long-term investments
|
|
|
|
|
|
|
|
|
Corporate notes
|
|
$
|
49,912
|
|
|
$
|
13,130
|
|
Certificates of deposit
|
|
|
11,278
|
|
|
|
3,633
|
|
Government and agency notes
|
|
|
4,917
|
|
|
|
—
|
|
Total long-term investments
|
|
$
|
66,107
|
|
|
$
|
16,763
|
|
Note 5. Balance Sheet Components
Prepaid expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Prepaid expenses
|
|
$
|
142
|
|
|
$
|
129
|
|
Prepaid insurance
|
|
|
2,342
|
|
|
|
858
|
|
Prepaid research and development expenses
|
|
|
3,737
|
|
|
|
4,517
|
|
Other current assets
|
|
|
883
|
|
|
|
688
|
|
Total prepaid expenses and other current assets
|
|
$
|
7,104
|
|
|
$
|
6,192
|
|
11
Property and Equipment
Property and equipment, net consist of the following (in thousands):
|
|
June 30
|
|
|
December 31
|
|
|
|
2020
|
|
|
2019
|
|
Computer equipment
|
|
$
|
33
|
|
|
$
|
28
|
|
Lab equipment
|
|
|
405
|
|
|
|
405
|
|
Finance lease right of use assets
|
|
|
556
|
|
|
|
559
|
|
Leasehold improvement
|
|
|
17
|
|
|
|
—
|
|
Less: accumulated amortization and depreciation
|
|
|
(446
|
)
|
|
|
(283
|
)
|
Property and equipment, net
|
|
$
|
565
|
|
|
$
|
709
|
|
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Personnel expenses
|
|
$
|
1,306
|
|
|
$
|
1,261
|
|
Professional fees
|
|
|
142
|
|
|
|
96
|
|
Research and development expenses
|
|
|
6,948
|
|
|
|
4,410
|
|
Other
|
|
|
206
|
|
|
|
50
|
|
Total accrued expenses and other current liabilities
|
|
$
|
8,602
|
|
|
$
|
5,817
|
|
Note 6. Leases
Real Estate Operating Leases
In June 2018, the Company entered into a three-year lease agreement with no renewal options with a related party, one of the investors in the Series B redeemable convertible preferred stock. The lease began on July 16, 2018 and provides 3,185 square feet of office and laboratory space in South San Francisco, California. The Company issued 114,437 shares of its Series B redeemable convertible preferred stock with a fair value of $1.1 million in exchange for the leased facility. No other payments are due under the lease. The common area maintenance and other operating costs are included in the base rent. 100% of the issued shares were initially subject to a repurchase option. Pursuant to the terms of the lease, each month beginning on the one-month anniversary of the commencement date of the lease, 1/36th of the total shares are released from the repurchase option until all shares are released over the lease period of three years. The scheduled release of shares ceased immediately upon the IPO which was a terminating event.
The Company completed its IPO on May 13, 2019 and as a result, pursuant to the terms of the lease agreement, all previously unvested shares were fully vested and as part of the IPO process, all outstanding shares of the Company’s redeemable convertible preferred stock including the Series B redeemable convertible preferred stock issued in connection with the lease agreement were converted into shares of the Company’s common stock on a 1-for-1 basis and the operating lease liability was extinguished.
In May 2019 the Company entered into an amendment to the lease agreement to rent additional space in the same facility under the same terms as its existing facility lease except the terms of payment. Under the terms of the amendment, the Company paid a one-time fee of approximately $63,000 for the additional space and the lease agreement will terminate in July 2021. No other payments are due under the lease agreement and no renewal option is available. As the entire lease is prepaid, there is no associated lease liability.
In May 2020 the Company entered into a second amendment to the lease agreement to rent additional space in the same facility under the same terms as its existing facility lease except the terms of payment. Under the terms of the amendment, the Company will pay rent monthly for the additional space and the lease agreement will terminate in July 2021. The Company recorded an operating lease asset and liability of $172,000.
In May 2020 the Company entered into a lease agreement to rent space in San Diego, California for our clinical operations team. The lease agreement is for three years commencing July 1, 2020. Total payments under the lease will be $346,000. The Company paid a security deposit of $29,400 and is included in Other Assets on our June 30, 2020 balance sheets. The lease did not create any other significant rights or obligations.
12
The Company recognizes lease expense on a straight-line basis over the term of its operating lease. As of June 30, 2020, future rent expense of $588,000 will be recognized over the remaining term of 13 months on a straight-line basis over the respective lease period.
Clinical Equipment Operating Lease
The Company uses certain vendor supplied equipment in connection with its on-going clinical trial. The Company has analyzed the vendor agreement and determined that it contains an embedded operating lease. The Company recognizes monthly the leases costs in our research and development expenses. The right of use asset and lease liability are recognized at the lease commencement date based on the present value of lease payments over the lease term. The Company’s lease does not provide an implicit rate. The Company used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. The remaining lease expense of $103,000 will be recognized over the remaining lease term of approximately 26 months.
Clinical Equipment Financing Lease
The Company uses certain vendor supplied equipment in connection with its on-going clinical trial. The Company has analyzed the vendor agreements and determined that they contain embedded finance leases. The Company recognizes the depreciation expense in research and development expenses in the statement of operations and recognizes expense on a straight-line basis starting when the equipment is placed into service until the end of the contract term ranging from 25 to 31 months. Amortization expense of the financing lease right of use asset for the six months ended June 30, 2020 and 2019 was $117,000 and $0 , respectively.
Supplemental balance sheet information related to leases as follows (in thousands except lease terms and discount rates):
|
|
|
June 30, 2020
|
|
|
December 31, 2019
|
|
Operating lease right of use asset, net
|
|
$
|
686
|
|
|
$
|
625
|
|
Short-term operating lease liability
|
|
|
|
205
|
|
|
|
|
—
|
|
Long-term operating lease liability
|
|
|
|
50
|
|
|
|
|
—
|
|
|
|
$
|
|
255
|
|
|
$
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance lease right of use asset
|
|
|
|
556
|
|
|
|
|
559
|
|
Finance lease accumulated amortization
|
|
|
|
(224
|
)
|
|
|
|
(107
|
)
|
Total finance lease right of use asset, net
|
|
$
|
|
332
|
|
|
$
|
|
452
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average remaining lease term
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
1.3 years
|
|
|
|
1.6 years
|
|
Finance leases
|
|
|
1.5 years
|
|
|
|
2.1 years
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average discount rate
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
|
2.32
|
%
|
|
|
|
—
|
%
|
Finance leases
|
|
|
|
—
|
%
|
|
|
|
—
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31,
|
|
|
Operating Lease
|
|
|
|
|
|
|
2020 (excluding the six months ended June 30, 2020)
|
|
|
|
105
|
|
|
|
|
|
|
2021
|
|
|
|
132
|
|
|
|
|
|
|
2022
|
|
|
|
23
|
|
|
|
|
|
|
Total lease payments
|
|
|
|
260
|
|
|
|
|
|
|
Less: imputed interest
|
|
|
|
(5
|
)
|
|
|
|
|
|
Total remaining lease liability
|
|
|
|
255
|
|
|
|
|
|
|
Note 7. Stock-Based Compensation
On December 4, 2014, the Company’s stockholders approved the 2014 Stock Plan (“2014 Plan”) and amended the 2014 Plan on April 25, 2019. The 2014 Plan was amended, restated and re-named the 2019 Equity Incentive Plan (the “2019 Plan”), which became effective as of May 7, 2019, the day prior to the effectiveness of the registration statement filed in connection with the IPO. The remaining shares available for issuance under the 2014 Plan were added to the shares reserved for issuance under the 2019 Plan.
13
The 2019 Plan provides for the grant of stock options (including incentive stock options and non-qualified stock options), stock appreciation rights, restricted stock, RSUs, performance units, and performance shares to the Company’s employees, directors, and consultants. The maximum aggregate number of shares that may be issued under the 2019 Plan is 5,131,549 shares of the Company’s common stock. In addition, the number of shares available for issuance under the 2019 Plan will be increased annually on the first day of each of its fiscal years beginning with fiscal 2020, by an amount equal to the least of (i) 2,146,354 shares of common stock; (ii) 4% of the outstanding shares of its common stock as of the last day of its immediately preceding fiscal year; and (iii) such other amount as the Company’s Board of Directors may determine.
The 2019 Plan may be amended, suspended or terminated by the Company’s Board of Directors at any time, provided such action does not impair the existing rights of any participant, subject to stockholder approval of any amendment to the 2019 Plan as required by applicable law or listing requirements. Unless sooner terminated by the Company’s Board of Directors, the 2019 Plan will automatically terminate on April 23, 2029.
As of June 30, 2020, the Company had 2,146,861 shares available for future issuance under the 2019 Plan.
For the three and six months ended June 30, 2020, the Company recognized $3,398,000 and $5,353,000 of stock-based compensation expense, respectively related to options granted to employees and non-employees. The compensation expense is allocated on a departmental basis, based on the classification of the option holder. No income tax benefits have been recognized in the statements of operations for stock-based compensation arrangements.
|
|
Number of
Options and
Unvested
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
average
remaining
contractual
life (years)
|
|
|
Aggregate
intrinsic
value
|
|
Balance at December 31, 2019
|
|
|
2,393,934
|
|
|
|
5.35
|
|
|
|
8.62
|
|
|
$
|
121,592,682
|
|
Options granted
|
|
|
1,535,145
|
|
|
|
50.93
|
|
|
|
|
|
|
|
|
|
Options exercised
|
|
|
(116,856
|
)
|
|
|
9.80
|
|
|
|
|
|
|
|
|
|
Options cancelled
|
|
|
(167,451
|
)
|
|
|
41.68
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2020
|
|
|
3,644,772
|
|
|
|
22.73
|
|
|
|
8.74
|
|
|
|
92,891,465
|
|
Options vested and expected to vest as of
June 30, 2020
|
|
|
3,644,772
|
|
|
|
22.73
|
|
|
|
8.74
|
|
|
|
92,891,465
|
|
Options exercisable as of June 30, 2020
|
|
|
1,137,492
|
|
|
|
6.83
|
|
|
|
7.86
|
|
|
|
45,506,270
|
|
Future stock-based compensation for unvested employee and non-employee options granted and outstanding as of June 30, 2020 is $52.5 million with a weighted average remaining expense life of 2.2 years.
The following table summarizes employee and non-employee stock-based compensation expense for the three and six months ended June 30, 2020 and 2019 and the allocation within the statements of operations and comprehensive loss (in thousands):
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
General and administrative expense
|
|
|
$
|
1,616
|
|
|
|
$
|
267
|
|
|
|
$
|
2,654
|
|
|
|
$
|
366
|
|
Research and development expense
|
|
|
|
1,782
|
|
|
|
|
110
|
|
|
|
|
2,699
|
|
|
|
|
201
|
|
Total stock-based compensation
|
|
|
$
|
3,398
|
|
|
|
$
|
377
|
|
|
|
$
|
5,353
|
|
|
|
$
|
567
|
|
Employee Stock Purchase Plan
On April 24, 2019, the Company’s Board of Directors adopted its 2019 Employee Stock Purchase Plan (“2019 ESPP”), which was subsequently approved by the Company’s stockholders and became effective on May 7, 2019, the day immediately prior to the effectiveness of the registration statement filed in connection with the IPO. The 2019 ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code (the “Code”) for U.S. employees. In addition, the 2019 ESPP authorizes grants of purchase rights that do not comply with Section 423 of the Code under a separate non-423 component for non-U.S. employees and certain non-U.S. service providers. The Company has reserved 536,989 shares of common stock for issuance under the 2019 ESPP. In addition, the number of shares reserved for issuance under the 2019 ESPP will be increased automatically on the first day of each fiscal year for a period of up to ten years, starting with the 2020 fiscal year, by a number equal to the least of: (i) 536,589 shares; (ii) 1% of the shares of common stock outstanding on the last day of the prior fiscal year; or (iii) such lesser number of shares determined by the Company’s Board of Directors. The 2019 ESPP is expected to be implemented through a series of offerings under which participants are granted purchase rights to purchase shares of the Company’s common stock on specified dates during such offerings. The Company has not yet approved an offering under the 2019 ESPP.
14
Note 8. Related Party Transactions
In June 2014, the Company entered into a research grant and license agreement (the Agreement) with a stockholder of the Company. The Agreement requires the Company to pay royalties to the stockholder in the amount of 3% of gross revenues not to exceed $1.05 million. This agreement was amended in April 2019 and the royalty payment provision was removed.
As described in Note 6, the Company entered into a three-year lease agreement with a Series B redeemable preferred stock investor. The lease began on July 16, 2018 and provides 3,185 square feet of office space in South San Francisco, California. The Company issued 114,437 restricted shares of its Series B redeemable convertible preferred stock in exchange for the use of the leased facility. In May 2019, the Company entered into an amendment to the lease agreement to rent additional space in the same building for a one-time payment of approximately $63,000 on the same terms as the July 2018 agreement except rent.
As described in Note 1, the Company completed its IPO in May 2019. As a result of the IPO, in addition to the 229,453 shares of Series B redeemable convertible preferred stock held by the investor, an additional 82,649 shares of the Company’s Series B redeemable convertible preferred stock under issued pursuant the lease agreement fully vested and were converted into common stock of the Company on a one-to-one basis.
As described in Note 1, on February 10, 2020, the Company issued and sold shares of common stock at a purchase price of $50.00 per share in a private placement. In the private placement, the Company issued and sold 30,000 shares of common stock for an aggregate purchase price of $1,500,000 to an entity affiliated with David A. Lamond, a member of the Company’s Board of Directors.
As described in Note 6, the Company entered into a second amendment to the lease agreement to rent additional space in the same facility under the same terms as its existing facility lease except the terms of payment. Under the terms of the amendment, the Company will pay rent monthly for the additional space and the lease agreement will terminate in July 2021. The Company recorded an operating lease asset and liability of $172,000.
Note 9. Income Taxes
The Company has a history of losses and expects to record a loss in 2020.
The Company accounts for income taxes under ASC Topic 740 – Income Taxes. Under this standard, deferred tax assets and liabilities are recognized for future tax benefits or consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
A valuation allowance is provided for significant deferred tax assets when it is more likely than not that such assets will not be realized through future operations. No provision for income taxes has been recorded due to the available net operating loss carry forwards. Future tax benefits which may arise as a result of these losses have not been recognized in these financial statements, as their realization is determined not likely to occur and accordingly, the Company has recorded a valuation allowance for the future deferred tax assets.
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") into law. The Company has reviewed the aspects of this law as it relates to income taxes and have concluded that at this time, the CARES Act will have no material impact to the Company’s 2020 provision for income taxes. The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.
Note 10. Net Loss Per Share
The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect:
|
|
June 30,
|
|
|
|
2020
|
|
|
2019
|
|
Options issued and outstanding
|
|
|
3,644,772
|
|
|
|
2,270,946
|
|
Total
|
|
|
3,644,772
|
|
|
|
2,270,946
|
|
15