[10-Q] Tyra Biosciences, Inc. Quarterly Earnings Report
Tyra Biosciences (TYRA) reported a wider quarterly net loss as it advanced multiple clinical programs. For the three months ended September 30, 2025, the company posted a net loss of $29.9 million versus $24.0 million a year ago. Operating expenses rose to $32.9 million, driven by R&D of $25.5 million and G&A of $7.5 million, while interest and other income contributed $3.1 million.
Liquidity remains strong with cash, cash equivalents and marketable securities of $274.9 million as of September 30, 2025. Net cash used in operations was $71.5 million for the first nine months of 2025. Management states this cash position is expected to fund operations through at least 2027.
Development highlights include progress across FGFR programs: dabogratinib Phase 2 studies in pediatric achondroplasia (BEACH301) and NMIBC (SURF302) are underway, UTUC (SURF303) received FDA clearance to initiate Phase 2, and TYRA-430 began dosing in a global Phase 1. Shares outstanding were 53,318,198 as of September 30, 2025; 53,372,098 were outstanding as of October 31, 2025.
- None.
- None.
Insights
R&D spend rises with advancing trials; liquidity remains solid.
TYRA increased investment as multiple studies progressed. Quarterly operating expenses reached
Cash, cash equivalents and marketable securities totaled
An at-the-market facility of up to
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:
Title of each class |
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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.
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 ☐ No
As of October 31, 2025, the registrant had
Table of Contents
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Page |
PART I. |
FINANCIAL INFORMATION |
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Item 1. |
Condensed Financial Statements |
2 |
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Condensed Balance Sheets |
2 |
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Condensed Statements of Operations and Comprehensive Loss |
3 |
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Condensed Statements of Stockholders' Equity |
4 |
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Condensed Statements of Cash Flows |
6 |
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Notes to the Condensed Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
17 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
27 |
Item 4. |
Controls and Procedures |
27 |
PART II. |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
28 |
Item 1A. |
Risk Factors |
28 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
28 |
Item 3. |
Defaults Upon Senior Securities |
28 |
Item 4. |
Mine Safety Disclosures |
28 |
Item 5. |
Other Information |
28 |
Item 6. |
Exhibits |
29 |
Signatures |
30 |
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1
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements
Tyra Biosciences, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
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September 30, |
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December 31, |
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2025 |
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2024 |
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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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Marketable securities |
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Prepaid expenses 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 assets |
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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 |
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$ |
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$ |
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Lease liabilities, current |
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Accrued expenses 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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Commitments and contingencies (Note 9) |
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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 other comprehensive income |
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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 condensed financial statements.
2
Tyra Biosciences, Inc.
Condensed 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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Nine Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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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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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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Other income: |
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Interest and other income, net |
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Total other income |
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Net loss |
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( |
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( |
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Unrealized gain (loss) on marketable securities |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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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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$ |
( |
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$ |
( |
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Weighted-average shares used to compute net |
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See accompanying notes to unaudited condensed financial statements.
3
Tyra Biosciences, Inc.
Condensed Statements of Stockholders’ Equity
(unaudited)
(in thousands, except share amounts)
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Common Stock |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive Income (Loss) |
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Accumulated |
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Total |
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Shares |
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Amount |
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Balance at December 31, 2023 |
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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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Issuance of pre-funded warrants, net |
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— |
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— |
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— |
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— |
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Issuance of common stock |
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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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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable |
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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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Balance at March 31, 2024 |
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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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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable |
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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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Balance at June 30, 2024 |
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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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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gain on marketable |
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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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( |
) |
Balance at September 30, 2024 |
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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 condensed financial statements.
4
Tyra Biosciences, Inc.
Condensed Statements of Stockholders’ Equity
(unaudited)
(in thousands, except share amounts)
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Common Stock |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive Income |
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Accumulated |
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Total |
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. |
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Shares |
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Amount |
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Balance at December 31, 2024 |
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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 |
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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 |
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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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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable |
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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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( |
) |
Balance at March 31, 2025 |
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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 |
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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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Unrealized loss on marketable |
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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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Balance at June 30, 2025 |
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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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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gain on marketable |
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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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Balance at September 30, 2025 |
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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 condensed financial statements.
5
Tyra Biosciences, Inc.
Condensed Statements of Cash Flows
(unaudited)
(in thousands)
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Nine Months Ended |
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2025 |
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2024 |
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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 operating activities: |
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Depreciation |
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Stock-based compensation |
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Accretion of marketable securities, net |
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( |
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( |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
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( |
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Accounts payable, accrued expenses and other liabilities |
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( |
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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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( |
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( |
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Cash flows from investing activities: |
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Purchases of marketable securities |
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( |
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( |
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Maturities of marketable securities |
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Purchases of property and equipment |
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( |
) |
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( |
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Net cash provided by (used in) investing activities |
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( |
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Cash flows from financing activities: |
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Proceeds from issuances of common stock under benefit plans |
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Proceeds from issuance of common stock and pre-funded warrants from Private Placement |
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Payments of issuance costs for common stock and pre-funded warrants from Private Placement |
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( |
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Net cash provided by financing activities |
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Net cash increase (decrease) for the period |
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( |
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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 |
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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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Non-cash investing and financing activities: |
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Purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities |
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$ |
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$ |
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Vesting of options early exercised subject to repurchase |
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$ |
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$ |
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See accompanying notes to unaudited condensed financial statements.
6
Tyra Biosciences, Inc.
Notes to the Condensed Financial Statements
(unaudited)
1. Organization and Summary of Significant Accounting Policies
Organization
Basis of Presentation
Summary of Significant Accounting Policies
During the three and nine months ended September 30, 2025, there have been no changes to the Company's significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Fair Value Measurements
The Company measures cash equivalents and available-for-sale debt securities at fair value. 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. Therefore, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. Fair value is affected by a number of factors, including the type of asset or liability, the characteristics specific to the asset or liability and the state of the marketplace, including the existence and transparency of transactions between market participants. 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 that 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).
7
Money market funds are highly liquid investments and are classified as Level 1. The pricing information for these assets is readily available and can be independently validated as of the measurement date. Available-for-sale debt securities, including U.S. Treasury securities and U.S. Agency bonds are classified as Level 2. These securities are valued using fair value from third-party pricing services, which may use observable inputs based on real-time trade data for similar assets, broker/dealer quotes, bids and/or offers and other observable inputs. The Company validates valuations obtained from third-party pricing services by understanding the models used and obtaining market values from independent sources.
Marketable Securities
Allowance for Credit Losses
The Company regularly reviews its portfolio for declines in fair value. For investments in an unrealized loss position, the Company assesses whether the decline is based on credit losses or other factor. As part of this assessment, the Company considers the cause of the impairment, the creditworthiness of the security issuers, current market conditions, the number of securities in an unrealized loss position, the severity of the losses, whether it will be required or will intend to sell the investment before recovery of its amortized cost basis. If fair value decline is determined to be due to a credit-related factor, the amortized cost basis is written down to fair value through net loss. If fair value decline is not due to credit-related factors, a loss is recorded in other comprehensive income or loss. The Company recognizes an allowance for credit losses up to the amount of the unrealized loss when appropriate.
We do not measure an allowance for credit losses for accrued interest receivables. For the purposes of identifying and measuring an impairment, accrued interest is excluded from both the fair value and amortized costs basis of the investment. Uncollectible accrued interest receivables associated with an impaired marketable security are reversed against interest income in a timely manner upon identification of the impairment.
Restricted Cash
Restricted cash is comprised of cash that is restricted as to its withdrawal or use under the terms of certain contractual agreements. Restricted cash as of September 30, 2025 and December 31, 2024 was $
Net Loss Per Share
8
Commitments and Contingencies
The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range.
Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of ASU 2023-09 on its financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, "Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses". In January 2025, the FASB issued ASU 2025-01, "Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date", to clarify the effective date of ASU 2024-03. These amendments are intended to provide more information about certain costs and expenses on an interim and annual basis. The amendments are effective for annual periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The new standards are expected to be applied prospectively, but retrospective application is permitted. The Company is currently evaluating the impact on its financial statements and related disclosures.
2. Fair Value Measurements
The following tables show the Company’s cash equivalents and marketable securities measured at fair value as of September 30, 2025 and December 31, 2024 (in thousands):
|
September 30, 2025 |
|
||||||||||
|
Total |
|
Quoted prices in active markets for identical assets (Level 1) |
|
Significant other observable inputs (Level 2) |
|
Significant unobservable inputs (Level 3) |
|
||||
Cash equivalents: |
|
|
|
|
|
|
|
|
||||
Money market funds |
$ |
|
$ |
|
$ |
|
$ |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
||||
U.S. government agency securities |
|
|
|
|
|
|
|
|
||||
Total marketable securities |
|
|
|
|
|
|
|
|
||||
Total |
$ |
|
$ |
|
$ |
|
$ |
|
||||
9
|
December 31, 2024 |
|
||||||||||
|
Total |
|
Quoted prices in active markets for identical assets (Level 1) |
|
Significant other observable inputs (Level 2) |
|
Significant unobservable inputs (Level 3) |
|
||||
Cash equivalents: |
|
|
|
|
|
|
|
|
||||
Money market funds |
$ |
|
$ |
|
$ |
|
$ |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
||||
U.S. government agency securities |
|
|
|
|
|
|
|
|
||||
Total marketable securities |
|
|
|
|
|
|
|
|
||||
Total |
$ |
|
$ |
|
$ |
|
$ |
|
||||
The carrying amounts of the Company’s prepaid and other current assets, accounts payable, and accrued and other current liabilities approximate fair value due to their short maturities. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. There were no transfers between Levels 1, 2 or 3 for any of the periods presented.
3. Marketable Securities
The following tables summarize the Company's marketable securities (see below and Note 2) accounted for as available-for-sale securities (in thousands, except years):
|
September 30, 2025 |
|
|||||||||||
|
Maturity |
Amortized cost |
|
Unrealized gains |
|
Unrealized losses |
|
Estimated fair value |
|
||||
U.S. Treasury securities |
Less than one |
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
U.S. government agency securities |
Less than one |
|
|
|
|
|
( |
) |
|
|
|||
U.S. Treasury securities |
1-2 |
|
|
|
|
|
( |
) |
|
|
|||
U.S. government agency securities |
1-2 |
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
|
December 31, 2024 |
|
|||||||||||
|
Maturity |
Amortized cost |
|
Unrealized gains |
|
Unrealized losses |
|
Estimated fair value |
|
||||
U.S. Treasury securities |
Less than one |
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
U.S. government agency securities |
Less than one |
|
|
|
|
|
( |
) |
|
|
|||
U.S. Treasury securities |
1-2 |
|
|
|
|
|
( |
) |
|
|
|||
U.S. government agency securities |
1-2 |
|
|
|
|
|
( |
) |
|
|
|||
Total |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
The following tables present fair values and gross unrealized losses for those available-for-sale securities that were in an unrealized loss position, aggregated by category and the length of time that the securities have been in a continuous loss position (in thousands):
|
September 30, 2025 |
|
|||||||||||||||||||||
|
Less than 12 months |
|
|
12 months or longer |
|
|
Total |
|
|||||||||||||||
|
Fair value |
|
|
Unrealized losses |
|
|
Fair value |
|
|
Unrealized losses |
|
|
Fair value |
|
|
Unrealized losses |
|
||||||
U.S. Treasury securities |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
U.S. government agency securities |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
||||
Total |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
10
|
December 31, 2024 |
|
|||||||||||||||||||||
|
Less than 12 months |
|
|
12 months or longer |
|
|
Total |
|
|||||||||||||||
|
Fair value |
|
|
Unrealized losses |
|
|
Fair value |
|
|
Unrealized losses |
|
|
Fair value |
|
|
Unrealized losses |
|
||||||
U.S. Treasury securities |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
U.S. government agency securities |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
||||
Total |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
As of September 30, 2025, there were
The amortized cost and fair value of marketable securities excludes $
4. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Accrued payroll and other employee benefits |
|
$ |
|
|
$ |
|
||
Accrued research and development expenses |
|
|
|
|
|
|
||
Accrued legal and professional fees |
|
|
|
|
|
|
||
Accrued other general and administrative fees |
|
|
|
|
|
|
||
Total accrued and other current liabilities |
|
$ |
|
|
$ |
|
||
5. Stockholders' Equity
Common stock reserved for future issuance consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||
Common stock options granted and outstanding |
|
|
|
|
|
|
||
Shares available for future issuance under the 2021 |
|
|
|
|
|
|
||
Shares available for future issuance under the |
|
|
|
|
|
|
||
Pre-funded warrants issued and outstanding |
|
|
|
|
|
|
||
Total common stock reserved for future issuance |
|
|
|
|
|
|
||
On October 3, 2022, the Company entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Agent), under which the Company could have, from time to time, sold shares of its common stock having an aggregate offering price of up to $
On May 8, 2025, the Company entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the 2025 Sales Agent), under which the Company may, from time to time, sell shares of its
11
common stock having an aggregate offering price of up to $
On February 1, 2024, the Company entered into a securities purchase agreement for a private placement of
On October 18, 2024, the Company entered into an exchange agreement with Boxer Capital and RA Capital, the Company's stockholders and related parties to the Company at the time of the exchange. Pursuant to the exchange agreement (i) Boxer Capital agreed to exchange
During the nine months ended September 30, 2025, Boxer Capital exercised
6. Equity Incentive Plans and Stock-Based Compensation
2021 Incentive Award Plan
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 Equity Incentive Plan (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. Shares that expire, terminate or are cancelled under the 2020 Plan are added back to the 2021 Plan share reserve. In addition, the number of shares of the Company’s common stock available for issuance under the 2021 Plan automatically increases on the first day of each fiscal year, beginning with the Company’s 2022 fiscal year, in an amount equal to the lesser of (1)
12
A summary of the Company’s stock option activity for the period ended September 30, 2025 was as follows (in thousands, except share and per share data and years):
|
|
Options |
|
|
Weighted-Average |
|
|
Weighted-Average |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Forfeited and expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest as of September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Employee Stock Purchase Plan
In September 2021, the Company’s Board of Directors adopted, and its stockholders approved, the 2021 Employee Stock Purchase Plan (ESPP).
Stock-Based Compensation Expense
The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for forfeitures of options when they occur. Previously recognized compensation expense for an unvested award is reversed in the period that the award is forfeited.
|
|
Nine Months Ended |
|
||
|
|
2025 |
|
2024 |
|
Risk-free rate of interest |
|
|
|
||
Expected term (years) |
|
|
|
||
Expected stock price volatility |
|
|
|
||
Dividend yield |
|
|
|
||
Stock-based compensation expense recognized for all equity awards has been reported in the condensed statements of operations and comprehensive loss as follows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The weighted-average grant date fair value of options granted (excluding modified options) for the nine months ended September 30, 2025 and 2024 was $
During the three months ended September 30, 2024, the Company recognized $
For the nine months ended September 30, 2025 and 2024, forfeitures resulting in the reversal of compensation expenses were immaterial.
13
As of September 30, 2025, the unrecognized compensation cost related to options was $
As of September 30, 2025, the unrecognized compensation cost related to ESPP was $
7. 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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Less: weighted-average unvested common stock issued upon early exercise of common stock options |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Weighted-average shares used to compute net loss per common share, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Shares issuable pursuant to the 2024 Pre-Funded Warrants and the Exchange Warrants are included in the calculation of weighted-average shares of common stock outstanding, both basic and diluted, for the three and nine months ended September 30, 2025. Shares issuable pursuant to the 2024 Pre-Funded Warrants are included in the calculation of weighted-average shares outstanding, both basic and diluted, for the three and nine months ended September 30, 2024. These warrants are exercisable at any time for nominal consideration, and therefore, the shares thereunder are considered outstanding for the purpose of calculating basic and diluted net loss per share.
The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive.
|
|
As of September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Unvested common stock upon early exercise of stock options |
|
|
|
|
|
|
||
Estimated shares purchasable under the ESPP |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
8. Leases
The Company has
In connection with the Company's lease agreements, the Company paid security deposits of $
Cash paid for amounts included in the measurement of lease liabilities was $
14
The components of lease expense include operating, short-term and variable lease costs. Amortization is recorded within research and development and general and administrative expenses in the condensed statements of operations and comprehensive loss.
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Operating lease cost |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Short-term lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Variable lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total lease cost |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Maturities of lease liabilities, weighted-average remaining term and weighted-average discount rate as of September 30, 2025 were as follows (in thousands):
Year ending December 31, |
|
|
|
|
2025 (remaining three months) |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum lease payments |
|
|
|
|
Less: amount representing interest |
|
|
( |
) |
Present value of lease liabilities |
|
|
|
|
Less: current portion of lease liabilities |
|
|
( |
) |
Lease liabilities, noncurrent |
|
$ |
|
|
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Weighted-average remaining lease term (years) - operating leases |
|
|
|
|
|
|
||
Weighted-average incremental borrowing rate - operating leases |
|
|
% |
|
|
% |
||
9. Commitments and Contingencies
Other Funding Commitments
As of September 30, 2025, the Company had ongoing clinical and pre-clinical studies for its various programs. The Company enters into contracts in the normal course of business with contract research organizations in preparation for clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties.
Litigation
15
10. Segment Information
The Company reports segment information based on the management approach, which reflects the way in which the internal reporting is used by the chief operating decision maker (CODM) to analyze performance, make decisions and allocate resources. The CODM is the Company’s Chief Executive Officer.
The Company manages its operations as a single reportable segment, which includes all activities related to the research, development, and potential future commercialization of its small molecule drug development candidates. The CODM assesses performance and decides how to allocate resources based on
The table below shows a reconciliation of the Company’s net loss, including the significant expense categories regularly provided to and reviewed by the CODM, to the Company’s total net loss in the condensed statements of operations and comprehensive loss (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
External research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Dabogratinib (TYRA-300ACH) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Dabogratinib (TYRA-300NMIBC) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Dabogratinib (TYRA-300UTUC) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Dabogratinib (TYRA-300mUC) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
TYRA-430 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
TYRA-200 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
FGFR discovery |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other development programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unallocated research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel costs(1) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Facilities and other costs(2) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total research and development expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses(3) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(1)
(2)
(3)
16
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis and the unaudited interim condensed 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, 2024 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, 2024 (the 2024 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 and phase of development, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the potential benefits of regulatory designations, the timing and likelihood of regulatory filings and approvals for our product candidates, the potential to develop product candidates and the safety and therapeutic benefits of our product candidates, our ability to commercialize our product candidates, if approved, the pricing and reimbursement of our product candidates, if approved, the timing and likelihood of success, 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 clinical-stage biotechnology company focused on developing next-generation precision medicines for large opportunities in targeted oncology and genetically defined conditions, with an initial focus on Fibroblast Growth Factor Receptor (FGFR) biology.
Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP approach to develop dabogratinib (formerly TYRA-300), TYRA-430 and TYRA-200: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.
Our FGFR3 Programs - Dabogratinib for Skeletal Conditions and Bladder Cancer
Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: skeletal conditions and bladder cancer. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth. In bladder cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation.
17
Our lead program, dabogratinib, was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4 to minimize off-target side effects, providing potential clinical advantages over less selective first-generation compounds and potentially addressing key unmet needs across both skeletal conditions and bladder cancer.
The current planned clinical development for dabogratinib includes Phase 2 clinical studies for the treatment of pediatric achondroplasia (BEACH301), treatment of low-grade intermediate risk non-muscle invasive bladder cancer (SURF302), our recent expansion into the treatment of low-grade upper tract urothelial carcinoma (SURF303), and potentially for the treatment of metastatic urothelial carcinoma (SURF301).
BEACH301: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating dabogratinib at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with achondroplasia (ACH) with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort planned for at least 3 participants per dose level in children ages 5 to 10. We dosed the first child in this study in August 2025. We expect to report interim results from the safety sentinel cohort in the second half of 2026.
SURF302: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered, low-grade intermediate risk (IR) non-muscle invasive bladder cancer (NMIBC). The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with dabogratinib at 50 mg once daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival, progression free survival, safety and tolerability. We dosed the first patient in this study in June 2025. We expect to report initial three-month CR data in the first half of 2026.
SURF303: We recently expanded our development of dabogratinib into low-grade upper tract urothelial carcinoma (LG-UTUC). This study is a multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered LG-UTUC. An investigational new drug application was cleared by the U.S. Food and Drug Administration in October 2025 to enable a Phase 2 study of dabogratinib in LG-UTUC. We expect to initiate this study in 2026.
SURF301: This ongoing study is an international, multicenter, open-label Phase 1/2 clinical trial that was designed to determine the optimal and maximum tolerated doses (MTD), and the recommended Phase 2 dose (RP2D) of dabogratinib, as well as to evaluate the preliminary antitumor activity of dabogratinib. In late October 2024, we reported interim data that in patients with FGFR3+ metastatic urothelial carcinoma (mUC) who received doses ≥ 90 mg once daily (QD), 6 out of 11 (54.5%) patients achieved a confirmed partial response. Preliminary data, as of the August 15, 2024 data cutoff, suggested dabogratinib was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study.
Our FGF19+ Program - TYRA-430 for Hepatocellular Carcinoma
FGF19 is a post-prandial enterohepatic hormone that signals through FGFR4 and its associated co-receptor Klotho Beta (KLB) to exert its normal cellular functions. In certain cancers, FGF19 is aberrantly expressed due to focal chromosomal amplifications or epigenetic mechanisms, promoting tumor cells to become dependent on the FGFR4/KLB/FGF19 oncogenic axis. Recent insights into FGF/FGFR signaling in HCC have indicated an important bypass mechanism in FGFR3, which shares the Klotho Beta coreceptor.
TYRA-430 was designed to be biased for FGFR4 and FGFR3 over the FGFR1 and FGFR2 isoforms specifically to address the FGF19 signaling pathway, while also potentially limiting side effects due to inhibition of FGFR1 and FGFR2, as well as to address acquired resistance mutations that have limited the efficacy of previous FGFR4-specific inhibitors. TYRA-430 is currently being evaluated in a global Phase 1 multicenter, open-label study, SURF431, that is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. TYRA-430 is initially being studied in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations. In April 2025, we commenced patient dosing in this study.
18
Our FGFR2 Program - TYRA-200 for Intrahepatic Cholangiocarcinoma
FGFR2 is a protein receptor present on the cell surface that promotes cellular proliferation and transformation upon binding of fibroblast growth factor. Activating gene alterations of FGFR2 have been implicated in the tumorigenesis of multiple solid tumor types, with pan-FGFR inhibitors approved for intrahepatic cholangiocarcinoma (ICC).
TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. TYRA-200 is currently being evaluated in a multicenter, open-label Phase 1 clinical study, SURF201, that is designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200, determine the optimal dose for further development and the MTD and RP2D, and evaluate preliminary antitumor activity.
Financial Overview
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, the issuance of Simple Agreements for Future Equity and the issuance of common stock and pre-funded common stock warrants through a private placement. Our net losses for the nine months ended September 30, 2025 and 2024 were $86.1 million and $60.9 million, respectively. As of September 30, 2025, we had an accumulated deficit of $337.4 million. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $274.9 million.
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 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 cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our operating expenses and capital expenditures through at least 2027. We have never generated any revenue and do not expect to generate any revenue from product sales unless and until we successfully complete the 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 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.
19
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:
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, such as personnel-related expenses, stock-based compensation expense, facility-related costs, and supplies, and certain external consultant costs on a program-specific basis because these costs are primarily 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.
20
Our future research and development expenses may vary significantly based on a wide variety of factors, such as:
21
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, finance and other administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, allocated facility-related costs, professional fees for accounting, tax, business development 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 additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance costs, and investor and public relations costs.
Other Income
Other income consists primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.
Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Three Months Ended September 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
25,469 |
|
|
$ |
22,697 |
|
|
$ |
2,772 |
|
General and administrative |
|
|
7,475 |
|
|
|
5,907 |
|
|
|
1,568 |
|
Total operating expenses |
|
|
32,944 |
|
|
|
28,604 |
|
|
|
4,340 |
|
Loss from operations |
|
|
(32,944 |
) |
|
|
(28,604 |
) |
|
|
(4,340 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest and other income, net |
|
|
3,076 |
|
|
|
4,588 |
|
|
|
(1,512 |
) |
Total other income |
|
|
3,076 |
|
|
|
4,588 |
|
|
|
(1,512 |
) |
Net loss |
|
$ |
(29,868 |
) |
|
$ |
(24,016 |
) |
|
$ |
(5,852 |
) |
22
Research and Development Expenses
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
|
|
Three Months Ended September 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
External research and development expenses by program: |
|
|
|
|
|
|
|
|
|
|||
Dabogratinib (TYRA-300ACH) |
|
$ |
3,590 |
|
|
$ |
2,182 |
|
|
$ |
1,408 |
|
Dabogratinib (TYRA-300NMIBC) |
|
|
1,821 |
|
|
|
— |
|
|
|
1,821 |
|
Dabogratinib (TYRA-300UTUC) |
|
|
498 |
|
|
|
— |
|
|
|
498 |
|
Dabogratinib (TYRA-300mUC) |
|
|
2,744 |
|
|
|
3,345 |
|
|
|
(601 |
) |
TYRA-430 |
|
|
2,299 |
|
|
|
1,621 |
|
|
|
678 |
|
TYRA-200 |
|
|
682 |
|
|
|
1,546 |
|
|
|
(864 |
) |
FGFR discovery |
|
|
2,362 |
|
|
|
2,124 |
|
|
|
238 |
|
Other development programs |
|
|
825 |
|
|
|
511 |
|
|
|
314 |
|
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Personnel costs |
|
|
8,858 |
|
|
|
9,574 |
|
|
|
(716 |
) |
Facilities and other costs |
|
|
1,790 |
|
|
|
1,794 |
|
|
|
(4 |
) |
Total research and development expenses |
|
$ |
25,469 |
|
|
$ |
22,697 |
|
|
$ |
2,772 |
|
Research and development expenses were $25.5 million and $22.7 million for the three months ended September 30, 2025 and 2024, respectively. The overall increase of $2.8 million was related to a:
General and Administrative Expenses
General and administrative expenses were $7.5 million and $5.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $1.6 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.2 million, driven by headcount growth.
Other Income
Other income was $3.1 million and $4.6 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of $1.5 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
23
Comparison of the Nine Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
74,742 |
|
|
$ |
57,897 |
|
|
$ |
16,845 |
|
General and administrative |
|
|
21,504 |
|
|
|
16,536 |
|
|
|
4,968 |
|
Total operating expenses |
|
|
96,246 |
|
|
|
74,433 |
|
|
|
21,813 |
|
Loss from operations |
|
|
(96,246 |
) |
|
|
(74,433 |
) |
|
|
(21,813 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest and other income, net |
|
|
10,133 |
|
|
|
13,523 |
|
|
|
(3,390 |
) |
Total other income |
|
|
10,133 |
|
|
|
13,523 |
|
|
|
(3,390 |
) |
Net loss |
|
$ |
(86,113 |
) |
|
$ |
(60,910 |
) |
|
$ |
(25,203 |
) |
Research and Development Expenses
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
External research and development expenses by program: |
|
|
|
|
|
|
|
|
|
|||
Dabogratinib (TYRA-300ACH) |
|
$ |
9,764 |
|
|
$ |
5,720 |
|
|
$ |
4,044 |
|
Dabogratinib (TYRA-300NMIBC) |
|
|
5,546 |
|
|
|
— |
|
|
|
5,546 |
|
Dabogratinib (TYRA-300UTUC) |
|
|
498 |
|
|
|
— |
|
|
|
498 |
|
Dabogratinib (TYRA-300mUC) |
|
|
7,992 |
|
|
|
11,408 |
|
|
|
(3,416 |
) |
TYRA-430 |
|
|
6,735 |
|
|
|
3,513 |
|
|
|
3,222 |
|
TYRA-200 |
|
|
3,475 |
|
|
|
3,501 |
|
|
|
(26 |
) |
FGFR discovery |
|
|
8,805 |
|
|
|
5,317 |
|
|
|
3,488 |
|
Other development programs |
|
|
1,798 |
|
|
|
2,082 |
|
|
|
(284 |
) |
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Personnel costs |
|
|
25,541 |
|
|
|
21,712 |
|
|
|
3,829 |
|
Facilities and other costs |
|
|
4,588 |
|
|
|
4,644 |
|
|
|
(56 |
) |
Total research and development expenses |
|
$ |
74,742 |
|
|
$ |
57,897 |
|
|
$ |
16,845 |
|
Research and development expenses were $74.7 million and $57.9 million for the nine months ended September 30, 2025 and 2024, respectively. The overall increase of $16.8 million was related to a:
General and Administrative Expenses
General and administrative expenses were $21.5 million and $16.5 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $5.0 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $3.3 million, driven by headcount growth.
24
Other Income
Other income was $10.1 million and $13.5 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of $3.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Liquidity and Capital Resources
Sources of Liquidity
On February 6, 2024, we completed a private placement and issued 9,286,023 shares of our common stock and pre-funded warrants to purchase an aggregate of 6,087,230 shares of our common stock (the 2024 Private Placement) for net proceeds of approximately $199.6 million, excluding issuance costs of $0.4 million.
On October 3, 2022, we entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Sales Agent), under which we could have, from time to time, sold shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2022 Sales Agent. We did not sell any shares under the 2022 Sales Agreement. In connection with the 2025 Sales Agreement (as defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement.
On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale or as otherwise agreed with the Sales Agent. The Sales Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of September 30, 2025, we had not sold any shares under the 2025 Sales Agreement.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Net cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|||
Operating activities |
|
$ |
(71,518 |
) |
|
$ |
(50,184 |
) |
|
$ |
(21,334 |
) |
Investing activities |
|
|
38,086 |
|
|
|
(105,361 |
) |
|
|
143,447 |
|
Financing activities |
|
|
3,417 |
|
|
|
201,431 |
|
|
|
(198,014 |
) |
Net increase (decrease) in cash and cash equivalents |
|
$ |
(30,015 |
) |
|
$ |
45,886 |
|
|
$ |
(75,901 |
) |
Operating Activities
The increase of $21.3 million in net cash used in operating activities for the nine months ended September 30, 2025, compared to the same period in 2024, was primarily due to an increase of $25.2 million in net loss and a decrease in net changes in operating assets and liabilities of $3.1 million, offset by an increase of $4.3 million in non-cash stock-based compensation expense and a decrease of $2.7 million in non-cash net accretion on marketable securities.
Investing Activities
The increase of $143.4 million in net cash provided by investing activities for the nine months ended September 30, 2025, compared to the same period in 2024, was driven by a reduction in purchases of marketable securities of $133.4 million, a $9.4 million increase in maturities of marketable securities, and a $0.6 million decrease in capital expenditures for property and equipment.
Financing Activities
The decrease of $198.0 million in net cash provided by financing activities for the nine months ended September 30, 2025, compared to the same period in 2024, was primarily due to the $199.6 million in net proceeds
25
from the 2024 Private Placement received during the nine months ended September 30, 2024. This decrease was partially offset by an increase of $1.6 million in proceeds from issuances of common stock under benefit plans.
Material Cash Requirements
Our material cash requirements consist of expected operating expenses to conduct our clinical trials and other research and development activities, personnel-related expenses and operating lease obligations.
Our primary uses of cash to date have been to fund our research and development activities, including with respect to dabogratinib, TYRA-430, 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.
Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to meet our anticipated operating expenses and capital expenditures through at least 2027. 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:
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
26
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 nine months ended September 30, 2025 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 2024 Annual Report.
As of September 30, 2025, total future aggregate operating lease commitments were $8.0 million, with approximately $0.2 million due during 2025, and the remaining due in periods from 2026 through 2033.
Critical Accounting Policies and Estimates
There have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2025, 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 2024 Annual Report.
Recently Adopted Accounting Pronouncements
See Note 1 to our condensed 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 September 30, 2025, 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 2024 Annual Report.
Item 4. Controls and Procedures
Our management, with the participation of our chief executive officer and our chief financial officer (our principal executive officer and principal financial and accounting officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this quarterly report. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As required by SEC Rule 13a-15(b), we carried out an evaluation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on such evaluation, our chief executive officer and our chief financial officer
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concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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 have been no material changes to the risk factors disclosed in Item 1A of our 2024 Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered Sales of Equity Securities
None.
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
Director and Officer Trading Arrangements
Rule 10b5-1 Trading Plans
From time to time, our officers (as defined in Rule 16a-1(f) of the Exchange Act) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three months ended September 30, 2025, none of our officers or directors
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Item 6. Exhibits
Exhibit Number |
|
Exhibit Description |
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Incorporated by Reference |
|
Filed Herewith |
||||
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|
|
|
Form |
|
Date |
|
Number |
|
|
3.1 |
|
Amended and Restated Certificate of Incorporation |
|
10-K |
|
3/22/23 |
|
3.1 |
|
|
3.2 |
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation, dated May 29, 2024 |
|
8-K |
|
5/31/24 |
|
3.1 |
|
|
3.3 |
|
Amended and Restated Bylaws, effective as of October 26, 2023 |
|
8-K |
|
10/26/23 |
|
3.1 |
|
|
4.1 |
|
Specimen stock certificate evidencing the shares of common stock |
|
S-1 |
|
8/20/21 |
|
4.1 |
|
|
4.2 |
|
Amended and Restated Investors’ Rights Agreement, dated March 5, 2021, by and among the Registrant and certain of its stockholders |
|
S-1/A |
|
9/9/21 |
|
4.2 |
|
|
4.3 |
|
Form of Pre-Funded Warrant |
|
8-K |
|
2/5/24 |
|
4.1 |
|
|
4.4 |
|
Form of Exchange Warrant |
|
8-K |
|
10/18/24 |
|
4.1 |
|
|
31.1 |
|
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
X |
31.2 |
|
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
X |
32.1* |
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
X |
32.2* |
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
X |
101.INS |
|
Inline XBRL Instance Document - the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document |
|
|
|
|
|
|
|
X |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
|
|
|
|
|
|
|
X |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
|
|
|
|
|
X
|
* 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.
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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.
|
|
TYRA BIOSCIENCES, INC. |
|
|
|
|
|
Date: November 5, 2025 |
|
By: |
/s/ Todd Harris, Ph.D. |
|
|
|
Todd Harris, Ph.D. |
|
|
|
President, Chief Executive Officer, and Director |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: November 5, 2025 |
|
By: |
/s/ Alan Fuhrman |
|
|
|
Alan Fuhrman |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
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FAQ
What was TYRA’s Q3 2025 net loss and operating expense mix?
How much cash and investments did TYRA have at quarter-end?
What was TYRA’s operating cash burn year-to-date?
Does TYRA expect its cash to fund operations for a defined period?
What clinical programs progressed during the period?
How many shares were outstanding?
Did TYRA use its at-the-market offering program?
