UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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 ☒
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of April 30, 2022, the registrant had
Table of Contents
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PART I. |
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Item 1. |
2 |
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3 |
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Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) |
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5 |
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6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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23 |
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
Tyra Biosciences, Inc.
Balance Sheets
(in thousands, except share and par value data)
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March 31, |
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December 31, |
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2022 |
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2021 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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Prepaid and other current assets |
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Total current assets |
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Restricted cash |
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Property and equipment, net |
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Right-of-use asset |
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Other long-term assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable (including related party amounts of $ |
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$ |
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$ |
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Lease liabilities, current |
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Accrued and other current liabilities |
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Total current liabilities |
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Lease liabilities, noncurrent |
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Other long-term liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to unaudited financial statements.
2
Tyra Biosciences, Inc.
Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share data)
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Three Months Ended |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative (including related party |
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Total operating expenses |
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Loss from operations |
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Other (expense) income: |
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Interest income |
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Other expense |
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Total other income |
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Net loss and comprehensive loss |
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$ |
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Net loss per share, basic and diluted |
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$ |
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$ |
( |
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Weighted-average shares used to compute net loss |
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See accompanying notes to unaudited financial statements.
3
Tyra Biosciences, Inc.
Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(unaudited)
(in thousands, except share amounts)
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Series A |
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Series B |
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Balance at December 31, 2020 |
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$ |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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Issuance of Series A convertible |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of Series B convertible |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock under |
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— |
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— |
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— |
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Vesting of shares of common |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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Balance at March 31, 2021 |
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$ |
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$ |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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Series A |
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Series B |
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Balance at December 31, 2021 |
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— |
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$ |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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Issuance of common stock under |
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— |
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— |
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Vesting of shares of common |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at March 31, 2022 |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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See accompanying notes to unaudited financial statements.
4
Tyra Biosciences, Inc.
Statements of Cash Flows
(unaudited)
(in thousands)
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Three Months Ended |
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2022 |
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2021 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operations: |
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Depreciation and amortization |
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Stock-based compensation |
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Loss on disposal of property and equipment |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
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Accounts payable, accrued expenses and other liabilities |
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Right-of-use assets and lease liabilities, net |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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Net cash used in investing activities |
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Cash flows from financing activities: |
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Proceeds from the issuance of Series A convertible preferred stock, net of issuance costs |
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Proceeds from the issuance of Series B convertible preferred stock, net of issuance costs |
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Proceeds from issuances of common stock under benefit plans |
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Payments for financing lease |
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Net cash provided by financing activities |
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Net cash (decrease) increase for the period |
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Cash, cash equivalents and restricted cash at beginning of the period |
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Cash, cash equivalents and restricted cash at end of the period |
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$ |
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$ |
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Reconciliation of cash, cash equivalents and restricted cash to the balance sheet |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Total cash, cash equivalents and restricted cash |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Right-of-use asset obtained in exchange for lease liability |
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$ |
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$ |
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Non-cash investing and financing activities: |
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Purchases of equipment included in accounts payable |
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Deferred offering costs included in accounts payable and accrued expenses |
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Series B issuance costs included in accounts payable and accrued expenses |
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See accompanying notes to unaudited financial statements.
5
Tyra Biosciences, Inc.
Notes to the Financial Statements
(unaudited)
1. Organization and Basis of Presentation
Organization
Tyra Biosciences, Inc. (the Company) was incorporated in the state of Delaware on
On September 17, 2021, the Company completed its initial public offering (the IPO) and issued
Stock Split
On September 7, 2021, the Company effected a
Basis of Presentation
The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). The accompanying unaudited financial statements do not include all of the information and notes required by GAAP for complete financial statements. These unaudited financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three months ended March 31, 2022 and 2021 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The balance sheet at March 31, 2022 has been derived from the financial statements at that date but does not include all disclosures required by GAAP for complete financial statements. Because all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited financial statements and the notes accompanying them should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
Liquidity and Capital Resources
From inception to March 31, 2022, the Company has devoted substantially all of its resources to organizing and staffing the company, business planning, raising capital, developing its proprietary SNÅP platform, undertaking research and development activities for its development programs, establishing its intellectual property portfolio, and providing general and administrative support for its operations. The Company has a limited operating history, has never generated any revenue, and the sales and income potential of its business is unproven. The Company has incurred net losses and negative cash flows from operating activities since its inception and expects to continue to incur net losses into the foreseeable future as it continues to develop its current and future product candidates. From inception through March 31, 2022, the Company funded its operations primarily through the issuance of common stock in its IPO, the sale of convertible preferred stock and the issuance of Simple Agreements for Future Equity (SAFEs).
The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty. Management is required to perform a two-step analysis over the Company’s ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern (Step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (Step 2).
Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these financial statements were available to be issued. There can be no assurance that the Company will be successful in
6
acquiring additional funding (if needed), that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years.
2. Summary of Significant Accounting Policies
During the three months ended March 31, 2022, there have been no changes to our significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
Commitments and Contingencies
Related Parties
Transactions between related parties are considered to be related party transactions even though they may not be given accounting recognition. FASB ASC 850, Related Party Disclosures (FASB ASC 850) requires that transactions with related parties that would make a difference in decision making shall be disclosed so that users of the financial statements can evaluate their significance. Related party transactions typically occur within the context of the following relationships:
Recently Issued Accounting Pronouncements
There were no other significant updates not already disclosed in the Company’s audited financial statements for the years ended December 31, 2021 and 2020 to the recently issued accounting standards for the three months ended March 31, 2022. Although there are several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results.
7
3. Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2—Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
Level 3—Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).
The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities. Included in cash and cash equivalents at March 31, 2022 and December 31, 2021 are money market funds with a carrying value and fair value of $
None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.
4. Property and Equipment
Property and equipment consisted of the following (in thousands):
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March 31, |
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December 31, |
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Equipment |
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$ |
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$ |
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Computers and software |
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Leasehold improvements |
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Furniture and fixtures |
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Less: accumulated depreciation |
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( |
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( |
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Total property and equipment, net |
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$ |
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$ |
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The Company recognized $
5. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
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March 31, |
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December 31, |
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Accrued payroll and other employee benefits |
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$ |
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$ |
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Accrued research and development |
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Accrued legal and professional fees |
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Accrued other general and administrative fees |
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Total accrued and other current liabilities |
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$ |
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$ |
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8
6
Convertible Preferred Stock
In January 2020 and February 2021, the Company issued, at each date,
In March 2021, the Company issued
In September 2021, upon completion of the IPO, all of the Company’s shares of convertible preferred stock converted into
Common Stock
Common stock reserved for future issuance consisted of the following:
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March 31, |
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December 31, |
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Common stock options granted and outstanding |
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Shares available for future issuance under the 2021 |
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Shares available for future issuance under the 2021 |
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Total common stock reserved for future issuance |
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Restricted Stock
Since inception, the Company has issued
For the three months ended March 31, 2022 and 2021,
7. Equity Incentive Plans and Stock-Based Compensation
Equity Incentive Plans
In September 2021, the Company's Board of Directors adopted, and its stockholders approved, the 2021 Incentive Award Plan (the 2021 Plan). Upon the adoption of the 2021 Plan, the Company restricted the grant of future equity awards under the 2020 Plan.
The 2021 Plan provides for the grants of stock options and other equity-based awards to employees, non-employee directors, and consultants of the Company. A total of
9
The options granted under the 2020 Plan and the 2021 Plan are exercisable at various dates as determined upon grant and will expire no more than
A summary of the Company’s stock option activity for the period ended March 31, 2022 is as follows:
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Options |
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Weighted-Average |
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Weighted-Average |
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Aggregate |
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Outstanding at December 31, 2021 |
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$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding at March 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at March 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest as of March 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
As of March 31, 2022,
Stock-Based Compensation Expense
The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited.
|
|
Three Months Ended |
|
||
|
|
2022 |
|
2021 |
|
Stock Options: |
|
|
|
|
|
Stock price |
|
$ |
|
$ |
|
Risk-free rate of interest |
|
|
|
||
Expected term (years) |
|
|
|
||
Expected stock price volatility |
|
|
|
||
Dividend yield |
|
|
|
Stock-based compensation expense recognized for all equity awards, including Founder's Stock, has been reported in the statements of operations and comprehensive loss as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Research and development expense |
|
$ |
|
|
$ |
|
||
General and administrative expense |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
The weighted-average grant date fair value of employee option grants for the three months ended March 31, 2022 and 2021 was $
10
As of March 31, 2022, the unrecognized compensation cost related to outstanding employee and nonemployee options was $
Employee Stock Purchase Plan
In September 2021, the Company’s Board of Directors approved and adopted the 2021 Employee Stock Purchase Plan (ESPP). The ESPP became effective on the business day immediately prior to the effective date of the Company’s first registration statement. A total of
Liability for Early Exercise of Stock Options
Certain individuals were granted the ability to early exercise their stock options prior to the IPO. The shares of common stock issued from the early exercise of unvested stock options are restricted and continue to vest in accordance with the original vesting schedule. The Company has the option to repurchase any unvested shares at the original purchase price upon any voluntary or involuntary termination. The shares purchased by the employees and non-employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares vest. The cash received in exchange for exercised and unvested shares related to stock options granted is recorded as a liability for the early exercise of stock options on the accompanying balance sheets and will be transferred into common stock and additional paid-in capital as the shares vest. As of March 31, 2022 and December 31, 2021,
8. Net Loss Per Share
The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):
|
|
Three Months Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Numerator: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
||
Weighted average shares used to compute net loss per |
|
|
|
|
|
|
||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive.
|
|
As of March 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Unvested restricted common stock subject to repurchase |
|
|
|
|
|
|
||
Unvested common stock upon early exercise of stock |
|
|
|
|
|
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
11
9. Leases
The Company has leases for its office and laboratory space, including its corporate headquarters, with terms that expire in 2033. The Company has two options to extend the term of the operating lease for a period of three years each. However, as the Company was not reasonably certain to exercise either of those options at lease commencement, neither option was recognized as part of the associated operating lease Right of Use (ROU) asset or liability.
In March 2022, the Company entered into an agreement (the Expansion Lease), for an additional office and laboratory space. The Expansion Lease is expected to commence in the second quarter of 2023 and projected lease payments over the life of the lease are expected to be $
In connection with the Company's operating leases, the Company paid a security deposit of $
The Company's operating lease cost was $
Maturities of lease liabilities, weighted-average remaining term and weighted-average discount rate were as follows (in thousands):
|
|
As of March 31, |
|
|
Year ending December 31, |
|
|
|
|
2022 (remaining nine months) |
|
$ |
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum lease payments |
|
|
|
|
Less: amount representing interest |
|
|
( |
) |
Present value of lease liabilities |
|
|
|
|
Less: current portion of lease liabilities |
|
|
( |
) |
Lease liabilities, noncurrent |
|
$ |
|
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Weighted-average remaining lease term |
|
|
|
|
|
|
||
Weighted-average incremental borrowing |
|
|
% |
|
|
% |
12
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis and the unaudited interim financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2021 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2021 (the 2021 Annual Report).
Forward-Looking Statements
This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the impact of the COVID-19 pandemic on our business, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions, including, without limitation, the risk factors described in Part II, Item 1A, “Risk Factors” of this Quarterly Report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Overview
We are a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. We are using our proprietary SNÅP platform, which is optimized to enable rapid and precise refinement of structural design through iterative molecular SNÅPshots, in order to generate next-generation product candidates that are specifically designed to address acquired drug resistance and provide alternative treatment options. We are initially focused on developing a pipeline of selective inhibitors of the Fibroblast Growth Factor Receptor (FGFR) family members, which are altered in approximately 7% of all cancers. We are advancing multiple product candidates toward the clinic including our lead product candidate TYRA-300, an FGFR3 inhibitor with an initial focus on patients with metastatic urothelial carcinoma of the bladder and urinary tract. Our second product candidate, TYRA-200, is an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma who have developed drug resistance mutations to existing FGFR inhibitors due to activating mutations and gene alterations in FGFR2. We anticipate submitting an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for TYRA-300 in mid-2022 and for TYRA-200 in the second half of 2022. In addition, we have pipeline development programs targeting FGFR3-related achondroplasia and other FGFR3-related skeletal dysplasias, REarranged during Transfection kinase (RET), and FGFR4-related cancers.
Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, and the issuance of Simple Agreement for Future Equity. Our net losses for the three months ended March 31, 2022 and 2021 were $14.8 million and $4.2 million, respectively. As of March 31, 2022, we had an accumulated deficit of $55.2 million. As of March 31, 2022, we had cash and cash equivalents of $292.5 million.
13
We have incurred significant operating losses since inception. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical development activities, other research and development activities and capital expenditures. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future particularly if and as we conduct preclinical studies and planned clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditures through at least 2024. We have never generated any revenue and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
The global COVID-19 pandemic continues to evolve, and we will continue to monitor the COVID-19 situation closely. The extent of the impact of the COVID-19 pandemic on our business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration and spread of the pandemic and its impact on our development activities, contract research organizations (CROs), third-party manufacturers and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel.
Components of Results of Operations
Operating Expenses
Research and Development Expenses
To date, our research and development expenses consist primarily of external and internal costs related to the development of our SNÅP platform and our product candidates and development programs. Our research and development expenses primarily include:
14
We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external expenses on a development program and other program specific basis. However, we do not track internal costs on a program specific basis because these costs primarily relate to compensation, early research and consumable costs, which are deployed across multiple programs under development.
Research and development activities are central to our business model. There are numerous factors associated with the successful development of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates and expand our pipeline, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel.
Our future research and development expenses may vary significantly based on a wide variety of factors such as:
15
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate.
The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates or any future candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our product candidates or any future candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and stock-based compensation charges, for personnel in executive and administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services and insurance costs. We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company. These increased costs will likely include increased expenses related to hiring of additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC, requirements, director and officer insurance costs, and investor and public relations costs.
Results of Operations
Comparison of the Three Months Ended March 31, 2022 and 2021
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Three Months Ended March 31, |
|
|
|
|
||||||
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
9,645 |
|
|
$ |
3,522 |
|
|
$ |
6,123 |
|
General and administrative |
|
|
5,189 |
|
|
|
689 |
|
|
|
4,500 |
|
Total operating expenses |
|
|
14,834 |
|
|
|
4,211 |
|
|
|
10,623 |
|
Loss from operations |
|
|
(14,834 |
) |
|
|
(4,211 |
) |
|
|
(10,623 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
18 |
|
|
|
2 |
|
|
|
16 |
|
Other expense |
|
|
(10 |
) |
|
|
— |
|
|
|
(10 |
) |
Total other income |
|
|
8 |
|
|
|
2 |
|
|
|
6 |
|
Net loss and comprehensive loss |
|
$ |
(14,826 |
) |
|
$ |
(4,209 |
) |
|
$ |
(10,617 |
) |
16
Research and Development Expenses
Research and development expenses were $9.6 million and $3.5 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $6.1 million was primarily due to additional spend to support the advancement of our TYRA-300, TYRA-200 and our SNÅP platform, including $2.8 million of higher personnel-related costs, including $1.4 million of non-cash stock-based compensation costs.
The following table summarizes our research and development expenses by development program for the three months ended March 31, 2022 and 2021 (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
External research and development expense by |
|
|
|
|
|
|
||
TYRA-300 |
|
$ |
2,292 |
|
|
$ |
1,340 |
|
TYRA-200 |
|
|
1,007 |
|
|
|
556 |
|
FGFR3 ACH |
|
|
570 |
|
|
|
— |
|
RET |
|
|
1,466 |
|
|
|
374 |
|
FGFR4 |
|
|
486 |
|
|
|
124 |
|
Other development programs |
|
|
121 |
|
|
|
— |
|
Unallocated research and development expense |
|
|
|
|
|
|
||
Other research and development |
|
|
599 |
|
|
|
208 |
|
Personnel-related expenses |
|
|
1,626 |
|
|
|
841 |
|
Stock-based compensation |
|
|
1,478 |
|
|
|
79 |
|
Total research and development expense |
|
$ |
9,645 |
|
|
$ |
3,522 |
|
General and Administrative Expenses
General and administrative expenses were $5.2 million and $0.7 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $4.5 million was primarily due to increases of $3.3 million in personnel-related expenses, including $2.4 million in non-cash stock-based compensation costs, $0.6 million in professional services related to legal, accounting, and other consulting fees and $0.6 million in other operating expenses.
Liquidity and Capital Resources
Sources of Liquidity
On September 17, 2021, we completed our IPO and issued 12,420,000 shares of common stock for net proceeds of approximately $181.2 million. Prior to our initial public offering, we funded our operations primarily through private placements of our convertible preferred stock with aggregate gross proceeds of $157.2 million.
Our primary uses of cash to date have been to fund our research and development activities, including with respect to TYRA-300 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Net cash used in operating activities |
|
$ |
(8,925 |
) |
|
$ |
(4,678 |
) |
Net cash used in investing activities |
|
|
(239 |
) |
|
|
(60 |
) |
Net cash provided by financing activities |
|
|
238 |
|
|
|
130,152 |
|
Net cash (decrease) increase for the period |
|
$ |
(8,926 |
) |
|
$ |
125,414 |
|
17
Operating Activities
Net cash used in operating activities for the three months ended March 31, 2022 was $8.9 million, consisting primarily of our net loss of $14.8 million, adjusted for $4.0 million of non-cash charges related to stock-based compensation expense and $1.9.0 million for net changes in operating assets and liabilities.
Net cash used in operating activities for the three months ended March 31, 2021 was $4.7 million, consisting primarily of our net loss of $4.2 million and $0.7 million for net changes in operating assets and liabilities, partially offset by $0.2 million of non-cash charges related to stock-based compensation expense.
Investing Activities
Net cash used in investing activities for the three months ended March 31, 2022 and 2021 was $0.2 million and $0.1 million, respectively, consisting of purchases of property and equipment.
Financing Activities
Net cash provided by financing activities was $0.2 million for the three months ended March 31, 2022 and was primarily related to $0.2 million from proceeds received from the issuance of common stock under benefit plans.
Net cash provided by financing activities was $130.2 million for the three months ended March 31, 2021, primarily related to net proceeds of $23.5 million from the second closing of our Series A convertible preferred stock, $106.1 million in net proceeds from the issuance of our Series B convertible preferred stock, and $0.6 million from proceeds received from the issuance of common stock under equity plans.
Future Funding Requirements
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to meet our anticipated operating expenses and capital expenditures through at least 2024. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
Our future capital requirements will depend on many factors, including:
18
Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Contractual Obligations and Commitments
Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2022 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2021 Annual Report.
The following table summarizes our contractual obligations and commitments as of March 31, 2022 (in thousands):
|
|
Payments Due by Period |
|
|||||||||||||||||
|
|
Total |
|
|
Remainder of |
|
|
2023-2024 |
|
|
2025-2026 |
|
|
Thereafter |
|
|||||
Operating lease obligations |
|
$ |
3,848 |
|
|
$ |
219 |
|
|
$ |
607 |
|
|
$ |
644 |
|
|
$ |
2,378 |
|
Critical Accounting Policies and Estimates
There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2022, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2021 Annual Report.
Recently Adopted Accounting Pronouncements
See Note 2 to our financial statements included elsewhere in this Quarterly Report on Form 10-Q for recently issued accounting pronouncements that may potentially impact our financial position and results of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of March 31, 2022, there have been no material changes surrounding our market risk, including interest rate risk, foreign currency exchange risk, and inflation risk, from the discussion provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures about Market Risk” in the 2021 Annual Report.
19
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation and supervision of our Chief Executive Officer and our Chief Financial Officer, have evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
Due to a transition period established by SEC rules applicable to newly public companies, our management is not required to evaluate the effectiveness of our internal control over financial reporting until the filing of our Annual Report on Form 10-K for the year ended December 31, 2022. As a result, this Quarterly Report on Form 10-Q does not address whether there have been any changes in our internal control over financial reporting.
20
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
Item 1A. Risk Factors
There has been no material changes to the risk factors disclosed in Item 1A of our 2021 Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered Sales of Equity Securities
None.
Use of Proceeds from Initial Public Offering
On September 14, 2021, our registration statement on Form S-1 (File No. 333-258970) was declared effective by the SEC for our IPO. At the closing of the offering on September 17, 2021, we sold 12,420,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,620,000 additional shares, at an initial public offering price of $16.00 per share and received gross proceeds of $198.7 million, which resulted in net proceeds to us of approximately $181.2 million, after deducting underwriting discounts and commissions of approximately $13.9 million and offering-related transaction costs of approximately $3.6 million. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to their associates, or to our affiliates. BofA Securities, Inc., Jefferies LLC, and Cowen and Company, LLC acted as joint book-running managers for the offering.
There has been no material change in the planned use of such proceeds from that described in our final prospectus filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on September 15, 2021.
Issuer Repurchases of Equity Securities
None.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
21
Item 6. Exhibits
Exhibit Number |
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Exhibit Description |
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Incorporated by Reference |
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Filed Herewith |
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Form |
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Date |
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Number |
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3.1 |
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8-K |
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9/17/21 |
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3.1 |
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3.2 |
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8-K |
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9/17/21 |
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3.2 |
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4.1 |
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Specimen stock certificate evidencing the shares of common stock |
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S-1 |
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8/20/21 |
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4.1 |
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4.2 |
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S-1/A |
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9/9/21 |
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4.2 |
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10.1 |
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First Amendment to Lease between the Registrant and Fabric 2656 State, LLC, dated March 2, 2022 |
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10-K |
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3/3/22 |
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10.14 |
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10.2 |
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Office Lease between the Registrant and Fabric 2676 State Street, LLC, dated March 2, 2022 |
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10-K |
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3/3/22 |
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10.15 |
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31.1 |
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X |
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31.2 |
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X |
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32.1* |
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Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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X |
32.2* |
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Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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X |
101.INS |
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Inline XBRL Instance Document |
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X |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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X |
101.CAL |
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Inline XBRL Taxonomy Calculation Linkbase Document |
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X |
101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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X |
101.LAB |
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Inline XBRL Taxonomy Label Linkbase Document |
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X |
101.PRE |
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Inline XBRL Presentation Linkbase Document |
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X |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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X
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# Indicates management contract or compensatory plan.
* This certification is deemed not filed for purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
22
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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TYRA BIOSCIENCES, INC. |
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Date: May 5, 2022 |
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By: |
/s/ Todd Harris, Ph.D. |
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Todd Harris, Ph.D. |
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President, Chief Executive Officer, and Director |
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(Principal Executive Officer) |
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Date: May 5, 2022 |
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By: |
/s/ Esther van den Boom |
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Esther van den Boom |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
23
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Todd Harris, certify that:
Date: May 5, 2022 |
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By: |
/s/ Todd Harris, Ph.D. |
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Todd Harris, Ph.D. |
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President, Chief Executive Officer, and Director |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Esther van den Boom, certify that:
Date: May 5, 2022 |
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By: |
/s/ Esther van den Boom |
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Esther van den Boom |
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Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Tyra Biosciences, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: May 5, 2022 |
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By: |
/s/ Todd Harris, Ph.D. |
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Todd Harris, Ph.D. |
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President, Chief Executive Officer, and Director |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Tyra Biosciences, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: May 5, 2022 |
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By: |
/s/ Esther van den Boom |
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Esther van den Boom |
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Chief Financial Officer |