Price | 24.65 | EPS | -1 | |
Shares | 27 | P/E | -27 | |
MCap | 662 | P/FCF | -30 | |
Net Debt | -121 | EBIT | -25 | |
TEV | 541 | TEV/EBIT | -22 | TTM 2019-09-30, in MM, except price, ratios |
10-Q | 2020-09-30 | Filed 2020-11-12 |
10-Q | 2020-06-30 | Filed 2020-08-14 |
S-1 | 2020-04-07 | Public Filing |
10-Q | 2020-03-31 | Filed 2020-05-12 |
10-K | 2019-12-31 | Filed 2020-03-16 |
10-Q | 2019-09-30 | Filed 2019-11-12 |
10-Q | 2019-06-30 | Filed 2019-08-09 |
S-1 | 2019-04-12 | Public Filing |
10-Q | 2019-03-31 | Filed 2019-06-12 |
8-K | 2021-02-12 | Other Events, Exhibits |
8-K | 2021-02-09 | Officers |
8-K | 2021-01-26 | Earnings, Other Events, Exhibits |
8-K | 2021-01-19 | Officers |
8-K | 2020-12-04 | Other Events |
8-K | 2020-06-08 | |
8-K | 2020-05-18 | |
8-K | 2020-05-12 | |
8-K | 2020-04-27 | |
8-K | 2020-03-17 | |
8-K | 2020-02-05 | |
8-K | 2019-05-13 |
Part I - Financial Information |
Item 1. Financial Statements. |
Note 1. Organization |
Note 2. Summary of Significant Accounting Policies |
Note 3. Fair Value Measurements |
Note 4: Cash, Cash Equivalents and Investments |
Note 5. Balance Sheet Components |
Note 6. Leases |
Note 7. Stock - Based Compensation |
Note 8. Related Party Transactions |
Note 9. Income Taxes |
Note 10. Net Loss per Share |
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. |
Item 3. Quantitative and Qualitative Disclosures About Market Risk. |
Item 4. Controls and Procedures. |
Part II - Other Information |
Item 1. Legal Proceedings. |
Item 1A. Risk Factors. |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. |
Item 3. Defaults Upon Senior Securities. |
Item 4. Mine Safety Disclosures. |
Item 5. Other Information. |
Item 6. Exhibits. |
EX-31.1 | crtx-ex311_9.htm |
EX-31.2 | crtx-ex312_7.htm |
EX-32.1 | crtx-ex321_10.htm |
EX-32.2 | crtx-ex322_8.htm |
Balance Sheet | Income Statement | Cash Flow |
---|---|---|
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
OR
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _______________ to _______________
Commission File Number: 001-38890
Cortexyme, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 90-1024039 |
( State or other jurisdiction of incorporation or organization) | (I.R.S. Employer |
269 East Grand Ave. South San Francisco, California | 94080 |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (415) 910-5717
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
| CRTX |
| Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
| ☐ |
| Accelerated filer |
| ☐ |
|
|
|
| |||
Non-accelerated filer |
| ☒ |
| Smaller reporting company |
| ☒ |
|
|
|
|
|
|
|
Emerging growth company |
| ☒ |
|
|
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 11, 2020, the registrant had 29,497,999 shares of common stock, $0.001 par value per share, outstanding.
|
| Page |
PART I. |
| |
Item 1. | 1 | |
| 1 | |
| 2 | |
| Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity | 4 |
| 5 | |
| 6 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 17 |
Item 3. | 24 | |
Item 4. | 25 | |
PART II. |
| |
Item 1. | 26 | |
Item 1A. | 26 | |
Item 2. | 33 | |
Item 3. | 34 | |
Item 4. | 34 | |
Item 5. | 34 | |
Item 6. | 35 | |
36 |
i
Cortexyme, Inc.
(Unaudited)
(In thousands, except share and per share amounts)
|
| September 30, 2020 |
|
| December 31, 2019 (1) |
| ||
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
| $ | 64,246 |
|
| $ | 51,214 |
|
Short term investments |
|
| 73,548 |
|
|
| 48,650 |
|
Prepaid expenses and other current assets |
|
| 5,180 |
|
|
| 6,192 |
|
Total current assets |
|
| 142,974 |
|
|
| 106,056 |
|
Property and equipment, net |
|
| 500 |
|
|
| 709 |
|
Operating lease right-of-use assets, net |
|
| 848 |
|
|
| 625 |
|
Long term investments |
|
| 60,133 |
|
|
| 16,763 |
|
Other assets |
|
| 209 |
|
|
| 217 |
|
Total assets |
| $ | 204,664 |
|
| $ | 124,370 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 4,309 |
|
| $ | 3,075 |
|
Accrued expenses and other current liabilities |
|
| 12,100 |
|
|
| 5,817 |
|
Total current liabilities |
|
| 16,409 |
|
|
| 8,892 |
|
Long-term operating lease liability |
|
| 244 |
|
|
| — |
|
Total liabilities |
|
| 16,653 |
|
|
| 8,892 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 authorized, no shares issued and outstanding as of September 30, 2020 and December 31, 2019 |
|
| — |
|
|
| — |
|
Common stock, $0.001 par value, 100,000,000 shares authorized, 29,494,249 and 26,869,413 issued and outstanding as of September 30, 2020 and December 31, 2019, respectively |
|
| 29 |
|
|
| 27 |
|
Additional paid in capital |
|
| 313,568 |
|
|
| 185,196 |
|
Accumulated other comprehensive income |
|
| 513 |
|
|
| 60 |
|
Accumulated deficit |
|
| (126,099 | ) |
|
| (69,805 | ) |
Total stockholders’ equity |
|
| 188,011 |
|
|
| 115,478 |
|
Total liabilities and stockholders’ equity |
| $ | 204,664 |
|
| $ | 124,370 |
|
(1) | The balance sheet as of December 31, 2019 is derived from the audited financial statements as of that date |
The accompanying notes are an integral part of these condensed financial statements.
1
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
|
| Three Months Ended September 30, |
|
| Nine Months Ended September 30, |
| ||||||||||
|
| 2020 |
|
| 2019 |
|
| 2020 |
|
| 2019 |
| ||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
| $ | 16,983 |
|
| $ | 8,253 |
|
| $ | 45,450 |
|
| $ | 20,187 |
|
General and administrative |
|
| 4,929 |
|
|
| 2,316 |
|
|
| 12,591 |
|
|
| 6,032 |
|
Total operating expenses |
|
| 21,912 |
|
|
| 10,569 |
|
|
| 58,041 |
|
|
| 26,219 |
|
Loss from operations |
|
| (21,912 | ) |
|
| (10,569 | ) |
|
| (58,041 | ) |
|
| (26,219 | ) |
Interest income |
|
| 406 |
|
|
| 711 |
|
|
| 1,747 |
|
|
| 1,618 |
|
Net loss |
|
| (21,506 | ) |
|
| (9,858 | ) |
|
| (56,294 | ) |
|
| (24,601 | ) |
Other comprehensive income / (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain / (loss) on available for sales securities |
|
| (198 | ) |
|
| 16 |
|
|
| 453 |
|
|
| 145 |
|
Total comprehensive loss |
| $ | (21,704 | ) |
| $ | (9,842 | ) |
| $ | (55,841 | ) |
| $ | (24,456 | ) |
Net loss per share - basic and diluted |
| $ | (0.73 | ) |
| $ | (0.37 | ) |
| $ | (1.94 | ) |
| $ | (1.59 | ) |
Weighted average shares of common stock outstanding - basic and diluted |
|
| 29,488,739 |
|
|
| 26,841,149 |
|
|
| 29,066,006 |
|
|
| 15,489,216 |
|
The accompanying notes are an integral part of these condensed financial statements.
2
Condensed Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except share and per share amounts)
For the three months ended September 30, 2020 and 2019 |
| |||||||||||||||||||||||
|
| Common Stock |
|
| Additional Paid in |
|
| Other Comprehensive |
|
| Accumulated |
|
| Shareholders' |
| |||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Income / (Loss) |
|
| Deficit |
|
| Equity |
| ||||||
Balance June 30, 2020 |
|
| 29,486,269 |
|
| $ | 29 |
|
| $ | 309,320 |
|
| $ | 711 |
|
| $ | (104,593 | ) |
| $ | 205,467 |
|
Exercise of stock options |
|
| 7,980 |
|
|
| — |
|
|
| 90 |
|
|
| — |
|
|
| — |
|
|
| 90 |
|
Stock based compensation |
|
| — |
|
|
| — |
|
|
| 4,158 |
|
|
| — |
|
|
| — |
|
|
| 4,158 |
|
Other comprehensive loss |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (198 | ) |
|
| — |
|
|
| (198 | ) |
Net loss |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (21,506 | ) |
|
| (21,506 | ) |
Balance September 30, 2020 |
|
| 29,494,249 |
|
| $ | 29 |
|
| $ | 313,568 |
|
| $ | 513 |
|
| $ | (126,099 | ) |
| $ | 188,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance June 30, 2019 |
|
| 26,841,149 |
|
| $ | 27 |
|
| $ | 183,678 |
|
| $ | 80 |
|
| $ | (47,568 | ) |
| $ | 136,217 |
|
Stock based compensation |
|
| — |
|
|
| — |
|
|
| 912 |
|
|
| — |
|
|
| — |
|
|
| 912 |
|
Other comprehensive income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| 16 |
|
|
| — |
|
|
| 16 |
|
Net loss |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (9,858 | ) |
|
| (9,858 | ) |
Balance September 30, 2019 |
|
| 26,841,149 |
|
| $ | 27 |
|
| $ | 184,590 |
|
| $ | 96 |
|
| $ | (57,426 | ) |
| $ | 127,287 |
|
The accompanying notes are an integral part of these condensed financial statements.
3
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity
(Unaudited)
(In thousands, except share and per share amounts)
For the nine months ended September 30, 2020 and 2019 |
| |||||||||||||||||||||||||||||||||||||||
|
| Series A Redeemable Convertible Preferred Stock |
|
| Series B Redeemable Convertible Preferred Stock |
|
| Common Stock |
|
| Additional Paid in |
|
| Other Comprehensive |
|
| Accumulated |
|
| Shareholders' |
| |||||||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Capital |
|
| Income / (Loss) |
|
| Deficit |
|
| Equity |
| ||||||||||
Balance January 1, 2020 |
|
| — |
|
| $ | — |
|
|
| — |
|
| $ | — |
|
|
| 26,869,413 |
|
| $ | 27 |
|
| $ | 185,196 |
|
| $ | 60 |
|
| $ | (69,805 | ) |
| $ | 115,478 |
|
Issuance of common stock in connection with private placement, net of issuance costs of $7,372 |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 2,500,000 |
|
|
| 2 |
|
|
| 117,626 |
|
|
| — |
|
|
| — |
|
|
| 117,628 |
|
Exercise of stock options |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 124,836 |
|
|
| — |
|
|
| 1,235 |
|
|
| — |
|
|
| — |
|
|
| 1,235 |
|
Stock based compensation |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 9,511 |
|
|
| — |
|
|
| — |
|
|
| 9,511 |
|
Other comprehensive income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 453 |
|
|
| — |
|
|
| 453 |
|
Net loss |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (56,294 | ) |
|
| (56,294 | ) |
Balance September 30, 2020 |
|
| — |
|
| $ | — |
|
|
| — |
|
| $ | — |
|
|
| 29,494,249 |
|
| $ | 29 |
|
| $ | 313,568 |
|
| $ | 513 |
|
| $ | (126,099 | ) |
| $ | 188,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance January 1, 2019 |
|
| 9,008,919 |
|
| $ | 17,178 |
|
|
| 9,152,108 |
|
| $ | 86,868 |
|
|
| 3,412,366 |
|
| $ | 3 |
|
| $ | 245 |
|
| $ | (49 | ) |
| $ | (32,825 | ) |
| $ | (32,626 | ) |
Exercise of stock options |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 166,015 |
|
|
| 1 |
|
|
| 68 |
|
|
| — |
|
|
| — |
|
|
| 69 |
|
Stock based compensation |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 1,479 |
|
|
| — |
|
|
| — |
|
|
| 1,479 |
|
Vesting of Series B redeemable convertible preferred stock in lieu of rent |
|
| — |
|
|
| — |
|
|
| — |
|
|
| 948 |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
Conversion of redeemable convertible preferred stock to common stock |
|
| (9,008,919 | ) |
|
| (17,178 | ) |
|
| (9,152,108 | ) |
|
| (87,816 | ) |
|
| 18,161,027 |
|
|
| 18 |
|
|
| 104,976 |
|
|
| — |
|
|
| — |
|
|
| 104,994 |
|
Initial public offering of common stock, net of issuance costs of $8,427 |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 5,073,800 |
|
|
| 5 |
|
|
| 77,822 |
|
|
| — |
|
|
| — |
|
|
| 77,827 |
|
Exercise of stock warrant |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 27,941 |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
Other comprehensive income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 145 |
|
|
| — |
|
|
| 145 |
|
Net loss |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| (24,601 | ) |
|
| (24,601 | ) |
Balance September 30, 2019 |
|
| — |
|
| $ | — |
|
|
| — |
|
| $ | — |
|
|
| 26,841,149 |
|
| $ | 27 |
|
| $ | 184,590 |
|
| $ | 96 |
|
| $ | (57,426 | ) |
| $ | 127,287 |
|
The accompanying notes are an integral part of these condensed financial statements.
4
Condensed Statements of Cash Flows
(Unaudited)
|
| For the Nine Months Ended September 30, |
| |||||
|
| 2020 |
|
| 2019 |
| ||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
| $ | (56,294 | ) |
| $ | (24,601 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Non-cash rent expense |
|
| 275 |
|
|
| 275 |
|
Stock based compensation |
|
| 9,511 |
|
|
| 1,479 |
|
Depreciation and amortization |
|
| 247 |
|
|
| 112 |
|
Amortization of premium (discount) on available for sale investments |
|
| 429 |
|
|
| (728 | ) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
| 1,044 |
|
|
| (3,281 | ) |
Other assets |
|
| 8 |
|
|
| (253 | ) |
Accounts payable |
|
| 1,234 |
|
|
| 1,800 |
|
Accrued expenses and other current liabilities |
|
| 6,004 |
|
|
| 2,870 |
|
Net cash used in operating activities |
|
| (37,542 | ) |
|
| (22,327 | ) |
Cash flow from investing activities: |
|
|
|
|
|
|
|
|
Purchase of investments |
|
| (183,356 | ) |
|
| (98,475 | ) |
Proceeds from maturities of investments |
|
| 115,141 |
|
|
| 63,070 |
|
Purchase of property and equipment |
|
| (42 | ) |
|
| (46 | ) |
Net cash used in investing activities |
|
| (68,257 | ) |
|
| (35,451 | ) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments of finance leases |
|
| (32 | ) |
|
| — |
|
Proceeds from issuance of common stock upon exercise of stock options |
|
| 1,235 |
|
|
| 69 |
|
Proceeds from initial public offering, net of stock offering costs |
|
| — |
|
|
| 77,827 |
|
Proceeds from private placement offering, net of issuance costs |
|
| 117,628 |
|
|
| — |
|
Net cash provided by financing activities |
|
| 118,831 |
|
|
| 77,896 |
|
Net change in cash and cash equivalents |
|
| 13,032 |
|
|
| 20,118 |
|
Cash, cash equivalents and restricted cash at beginning of period |
|
| 51,214 |
|
|
| 24,872 |
|
Cash, cash equivalents and restricted cash at end of period |
| $ | 64,246 |
|
| $ | 44,990 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of non-cash information: |
|
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for new operating lease liabilities |
| $ | 620 |
|
| $ | 878 |
|
Right-of-use assets obtained in exchange for new finance lease liabilities |
| $ | — |
|
| $ | 500 |
|
Conversion of Series A redeemable convertible preferred stock to common stock on initial public offering |
| $ | — |
|
| $ | 17,178 |
|
Conversion of Series B redeemable convertible preferred stock to common stock on initial public offering |
| $ | — |
|
| $ | 87,816 |
|
Acceleration of vesting of Series B redeemable convertible preferred stock on initial public offering |
| $ | — |
|
| $ | 856 |
|
The accompanying notes are an integral part of these condensed financial statements.
5
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.
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 September 30, 2020, the Company had an accumulated deficit of $126.1 million. Since inception through September 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 September 30, 2020, the Company had cash, cash equivalents, and short-term investments of $137.8 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 $60.1 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 September 30, 2020, the condensed statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2019, the condensed statements of redeemable convertible preferred stock and stockholders’ equity for the three and nine months ended September 30, 2020 and 2019, the condensed statements of cash flows for the nine months ended September 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 nine months ended September 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 and beyond.
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 nine months ended September 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
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
8
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.
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 September 30, 2020 and December 31, 2019 are presented in the following tables (in thousands):
|
| Fair Value Measurements at September 30, 2020 |
| |||||||||||||
|
| Total |
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
| ||||
Money market funds |
| $ | 61,172 |
|
| $ | 61,172 |
|
| $ | — |
|
| $ | — |
|
Certificates of deposit |
|
| 39,296 |
|
|
| — |
|
|
| 39,296 |
|
|
| — |
|
Municipal notes |
|
| 3,061 |
|
|
| — |
|
|
| 3,061 |
|
|
| — |
|
Corporate notes |
|
| 81,112 |
|
|
| — |
|
|
| 81,112 |
|
|
| — |
|
Government and agency notes |
|
| 11,192 |
|
|
| — |
|
|
| 11,192 |
|
|
| — |
|
Total |
| $ | 195,833 |
|
| $ | 61,172 |
|
| $ | 134,661 |
|
| $ | — |
|
|
| 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 |
|
|
| — |
|