QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
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||
(Address of Principal Executive Offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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Capital Market |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
Page |
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5 |
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Item 1. |
5 |
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5 |
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6 |
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7 |
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9 |
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10 |
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Item 2. |
22 |
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Item 3. |
28 |
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Item 4. |
28 |
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29 |
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Item 1. |
29 |
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Item 1A. |
29 |
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Item 2. |
62 |
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Item 3. |
62 |
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Item 4. |
62 |
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Item 5. |
62 |
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Item 6. |
63 |
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64 |
• |
our expected future growth and our ability to manage such growth; |
• |
our ability to develop, obtain regulatory approval for and commercialize TPST-1495 and TPST-1120 and our future product candidates; |
• |
the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
• |
the development, regulatory approval, efficacy and commercialization of competing products; |
• |
our ability to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates. |
• |
our ability to retain regulatory approval for our product candidates or future product candidates in the United States and in any foreign countries in which we make seek to do business; |
• |
our ability to retain and hire our board of directors, senior management, or operational personnel; |
• |
our ability integrate TempestTx, Inc. and Millendo Therapeutics, Inc. (now the Company) successfully and realize the anticipated benefits of the merger of the two entities, which close in July 2021; |
• |
our expectations regarding the period during which we will qualify as a smaller reporting company under the federal securities laws; |
• |
our ability to develop and maintain our corporate infrastructure, including our ability to remediate our existing material weakness and to design and maintain an effective system of internal controls; |
• |
our financial performance and capital requirements; and |
• |
our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our products and technology, as well as our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others. |
(Unaudited) June 30, 2021 |
December 31, 2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
Prepaid expenses and other current assets |
||||||||
Total current assets |
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Property and equipment — net |
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Operating lease right-of-use |
||||||||
Other noncurrent assets |
||||||||
Total assets |
$ | $ | ||||||
Liabilities and stockholders’ equity (deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Current operating lease liabilities |
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Accrued compensation |
||||||||
Interest payable |
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Early option exercise liability |
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Total current liabilities |
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Loan payable (net of issuance costs of $ |
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Operating lease liabilities |
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Total liabilities |
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Commitments and contingencies (Note 8) |
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Convertible preferred stock, $ par value; 2020, respectively; |
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Stockholders’ equity (deficit): |
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Common stock, $ par value; 2020, respectively; |
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Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ equity (deficit) |
( |
) | ||||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
$ | $ | ||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
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2021 |
2020 |
2021 |
2020 |
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Operating expenses: |
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Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
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Loss from operations |
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Other income (expense): |
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Interest expense |
$ | ( |
) | $ | $ | ( |
) | $ | ||||||||
Interest income and other income (expense), net |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Net loss per share of common stock, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Weighted-average shares of common stock outstanding, basic and diluted |
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Three Months Ended June 30, 2021 |
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Series A Convertible |
Series B Convertible |
Series B1 Convertible |
Additional Paid-In Capital |
Deficit Accumulated |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Prefer110red Stock |
Preferred Stock |
Common Stock |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||
BALANCE—March 31, 2021 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Vesting of early exercised stock options |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | — | |||||||||||||||||||||||||||||||
Issuance of common stock for cash |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Reverse recapitalization transaction costs |
— | — | — | — | — | — | — | — | ( |
) | — | ( |
) | |||||||||||||||||||||||||||||||
Record pre-merger Millendo stockholders’ equity and elimination of Millendo historical accumulated deficit |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
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|||||||||||||||||||||||
BALANCE—June 30, 2021 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||||||||||||||
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Three Months Ended June 30, 2020 |
||||||||||||||||||||||||||||||||||||||||||||
Series A Convertible |
Series B Convertible |
Series B1 Convertible |
Additional Paid-In Capital |
Deficit Accumulated |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Preferred Stock |
Preferred Stock |
Common Stock |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||
BALANCE—March 31, 2020 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||||||||
Vesting of early exercised stock options |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
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|||||||||||||||||||||||
BALANCE—June 30, 2020 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||||||||
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Six Months Ended June 30, 2021 |
||||||||||||||||||||||||||||||||||||||||||||
Series A Convertible |
Series B Convertible |
Series B1 Convertible |
Additional Paid-In Capital |
Deficit Accumulated |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Preferred Stock |
Preferred Stock |
Common Stock |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||
BALANCE—December 31, 2020 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Vesting of early exercised stock options |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | — | |||||||||||||||||||||||||||||||
Issuance of common stock for cash |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Reverse recapitalization transaction costs |
— | — | — | — | — | — | — | — | ( |
) | — | ( |
) | |||||||||||||||||||||||||||||||
Record pre-merger Millendo stockholders’ equity and elimination of Millendo historical accumulated deficit |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
BALANCE—June 30, 2021 |
$ | $ | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||||||||||||||
Six Months Ended June 30, 2020 |
||||||||||||||||||||||||||||||||||||||||||||
Series A Convertible |
Series B Convertible |
Series B1 Convertible |
Additional Paid-In Capital |
Deficit Accumulated |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Preferred Stock |
Preferred Stock |
Common Stock |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||
BALANCE—December 31, 2019 |
$ | $ | $ | $ | — | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||||||||||||
Exercise of options—net of |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Issuance of preferred stock for cash—net of issuance costs of $ |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Vesting of early exercised stock options |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
BALANCE—June 30, 2020 |
$ | $ | $ | $ | — | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||||||||||||
Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation expense |
||||||||
Stock-based compensation expense |
||||||||
Noncash lease expense |
||||||||
Noncash related party interest income |
( |
) | ( |
) | ||||
Noncash interest and other expense |
— | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ||||||
Accounts payable |
( |
) | ||||||
Accrued expenses and other liabilities |
( |
) | ( |
) | ||||
Interest payable |
— | |||||||
Operating lease liabilities |
( |
) | ||||||
|
|
|
|
|||||
Cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Investing activities: |
||||||||
Purchase of property and equipment |
( |
) | ( |
) | ||||
Repayment of note receivable |
||||||||
|
|
|
|
|||||
Cash (used in) provided by investing activities |
( |
) | ||||||
|
|
|
|
|||||
Financing activities: |
||||||||
Proceeds from issuance of preferred stock |
||||||||
Payment of preferred stock issuance costs |
( |
) | ||||||
Proceeds from the issuance of common stock |
||||||||
Borrowings on loan payable |
— | |||||||
Payment of loan issuance costs |
( |
) | ||||||
Cash acquired in connection with the reverse recapitalization |
— | |||||||
Payment of reverse recapitalization transaction costs |
( |
) | — | |||||
Proceeds from option exercises |
||||||||
|
|
|
|
|||||
Cash provided by financing activities |
||||||||
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|||||
Net increase in cash and cash equivalents |
||||||||
Cash and cash equivalents and restricted cash at beginning of period |
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Cash and cash equivalents and restricted cash at end of period |
$ | $ | ||||||
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|||||
Supplemental disclosure of cashflow information: |
||||||||
Cash paid for interest |
$ | $ | — | |||||
|
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|
|
|||||
Supplemental schedule of non-cash investing and financing activities: |
||||||||
Vesting of early exercise stock options |
$ | $ | ||||||
|
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|
1. |
ORGANIZATION AND DESCRIPTION OF THE BUSINESS |
2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Computer equipment and software |
||
Furniture and fixtures |
||
Laboratory equipment |
||
Leasehold improvements |
3. |
MILLENDO MERGER |
4. |
FAIR VALUE MEASUREMENTS |
June 30, 2021 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Cash and cash equivalents |
$ | $ | $ | $ | ||||||||||||
Short-term restricted cash |
||||||||||||||||
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|
|||||||||
Total assets |
$ | $ | $ | $ | ||||||||||||
December 31, 2020 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Cash and cash equivalents |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total assets |
$ | $ | $ | $ |
5. |
TRANSACTIONS WITH RELATED PARTIES (AMOUNTS IN THOUSANDS) |
6. |
BALANCE SHEET ITEMS (AMOUNTS IN THOUSANDS) |
June 30, 2021 |
December 31, 2020 |
|||||||
Prepaid expenses |
$ | $ | ||||||
Research tax credit |
||||||||
Prepaid research and development costs |
||||||||
Notes and interest receivable |
||||||||
Other current assets |
||||||||
$ | |
$ | |
|||||
June 30, 202 1 |
December 31, 2020 |
|||||||
Computer equipment and software |
$ | $ | ||||||
Furniture and fixtures |
||||||||
Lab equipment |
||||||||
Leasehold improvements |
||||||||
Property and equipment |
||||||||
Less accumulated depreciation |
( |
) | ( |
) | ||||
Property and equipment—net |
$ | |
$ | |
||||
June 30, 2021 |
December 31, 2020 |
|||||||
Accrued other liabilities |
$ | $ | ||||||
Accrued clinical trial liability |
||||||||
$ | |
$ | |
|||||
7. |
EARLY OPTION EXERCISE LIABILITY (AMOUNTS IN THOUSANDS) |
8. |
COMMITMENTS AND CONTINGENCIES (AMOUNTS IN THOUSANDS) |
Year Ending |
Total Commitment |
|||
2021 (excluding the six months ended June 30, 2021) |
$ | |||
2022 |
||||
2023 |
||||
2024 |
||||
2025 |
— | |||
|
|
|||
Total minimum lease payments |
||||
Less: imputed interest |
( |
) | ||
|
|
|||
Present value of operating lease obligations |
||||
Less: current portion |
( |
) | ||
|
|
|||
Noncurrent operating lease obligations |
$ | |||
|
|
9. |
LOAN PAYABLE (AMOUNTS IN THOUSANDS) |
10. |
CONVERTIBLE PREFERRED STOCK |
December 31, 2020 |
||||||||||||||||||||||||
Series |
Shares Authorized |
Shares Issued and Outstanding |
Per Share Liquidation Preference |
Aggregate Liquidation Amount |
Proceeds Net of Issuance Cost |
Net Carrying Value |
||||||||||||||||||
Series A |
$ | |
$ | $ | |
$ | |
|||||||||||||||||
Series B |
||||||||||||||||||||||||
Series B-1 |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
$ | |
$ | $ | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
11. |
COMMON STOCK |
12. |
STOCK COMPENSATION |
Weighted- |
||||||||||||
Shares |
Average |
|||||||||||
Available |
Total Options |
Exercise |
||||||||||
for Grant |
Outstanding |
Price |
||||||||||
Balance—January 1, 2021 |
$ | |||||||||||
Assumed in reverse recapitalization |
— | |||||||||||
Granted |
( |
) | ||||||||||
Exercised |
— | ( |
) | |||||||||
Cancelled and forfeited |
( |
) | ||||||||||
|
|
|
|
|||||||||
Balance—June 30, 2021 |
||||||||||||
|
|
|
|
Weighted |
||||||||||||||||
Average |
Weighted |
|||||||||||||||
Remaining |
Average |
Aggregate |
||||||||||||||
Contractual |
Exercise |
Intrinsic |
||||||||||||||
Shares |
Life (In Years) |
Price |
Value |
|||||||||||||
Options outstanding |
$ | |
$ | |
||||||||||||
Vested and expected to vest |
$ | $ | ||||||||||||||
Exercisable |
$ | $ |
Expected term (in years) |
||||
Expected volatility |
||||
Risk-free interest rate |
||||
Dividends |
Expected term (in years) |
||||
Expected volatility |
% | |||
Risk-free interest rate |
% | |||
Dividends |
% |
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Research and development |
$ | $ | |
$ | |
$ | |
|||||||||
General and administrative |
( |
) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | |
$ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
13. |
RETIREMENT PLAN |
14. |
NET LOSS PER SHARE |
Three months ended June 30, |
||||||||
Numerator: |
2021 |
2020 |
||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Denominator: |
||||||||
Weighted-average common shares outstanding |
||||||||
Less: Weighted-average unvested restricted shares and shares subject to repurchase |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Weighted-average shares used to computing basic and diluted net loss per share |
||||||||
|
|
|
|
|||||
Net loss per share attributable to common stockholders—basic and diluted |
$ |
( |
) |
$ |
( |
) | ||
|
|
|
|
Six months ended June 30, |
||||||||
2021 |
2020 |
|||||||
Numerator: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Denominator: |
||||||||
Weighted-average common shares outstanding |
||||||||
Less: Weighted-average unvested restricted shares and shares subject to repurchase |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Weighted-average shares used to computing basic and diluted net loss per share |
||||||||
|
|
|
|
|||||
Net loss per share attributable to common stockholders—basic and diluted |
$ |
( |
) |
$ |
( |
) | ||
|
|
|
|
June 30, 2021 |
June 30, 2020 |
|||||||
Options to purchase common stock |
||||||||
Redeemable convertible preferred stock |
||||||||
Unvested restricted common stock |
||||||||
Common stock warrants |
||||||||
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|||||
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15. |
SUBSEQUENT EVENTS |