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    SEC Form 10-Q filed by Tyra Biosciences Inc.

    5/8/25 4:10:01 PM ET
    $TYRA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $TYRA alert in real time by email
    10-Q
    Q112-31false0001863127November 30, 2033http://tyra.bio/20250331#ChiefOperatingDecisionMakerMember0001863127us-gaap:EmployeeStockMember2025-01-012025-03-310001863127us-gaap:USGovernmentCorporationsAndAgenciesSecuritiesMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-310001863127us-gaap:AdditionalPaidInCapitalMember2024-03-310001863127us-gaap:PrivatePlacementMemberus-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-310001863127us-gaap:AdditionalPaidInCapitalMember2023-12-310001863127us-gaap:LeaseholdImprovementsMember2025-03-310001863127tyra:PersonnelCostsMembertyra:ChiefOperatingDecisionMakerMember2024-01-012024-03-310001863127us-gaap:FairValueInputsLevel3Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2025-03-310001863127us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-310001863127tyra:EstimatedSharesPurchasableUnderTheEsppMember2024-01-012024-03-310001863127tyra:AtmSalesAgreementMember2022-10-032022-10-030001863127us-gaap:AdditionalPaidInCapitalMember2024-12-310001863127us-gaap:CommonStockMemberus-gaap:EmployeeStockMember2025-03-310001863127us-gaap:WarrantMember2024-01-012024-03-310001863127tyra:TwentyTwentyOneEmployeeStockPurchasePlanMember2025-03-310001863127us-gaap:FairValueInputsLevel3Memberus-gaap:USGovernmentCorporationsAndAgenciesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2025-03-310001863127us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2025-03-310001863127us-gaap:USTreasurySecuritiesMember2024-12-310001863127tyra:AccumulatedOtherComprehensiveLossMember2025-01-012025-03-310001863127tyra:TwentyTwentyOneEmployeeStockPurchasePlanMember2024-12-310001863127tyra:TwoThousandTwentyFourPrivatePlacementMember2024-02-062024-02-0600018631272024-03-3100018631272024-12-310001863127us-gaap:FurnitureAndFixturesMember2024-12-310001863127tyra:StockOptionsToPurchaseCommonStockMember2024-01-012024-03-310001863127tyra:BoxerCapitalLlcMembertyra:TwoThousandTwentyFourPreFundedWarrantsMember2025-01-012025-03-310001863127tyra:UnvestedCommonStockExerciseOfStockOptionsMember2025-01-012025-03-310001863127us-gaap:RetainedEarningsMember2024-12-310001863127us-gaap:CommonStockMembertyra:BoxerCapitalLlcMember2024-10-182024-10-180001863127us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-310001863127us-gaap:CommonStockMember2025-03-310001863127us-gaap:FairValueMeasurementsRecurringMember2025-03-3100018631272025-05-050001863127tyra:TwoThousandsAndTwentyOneIncentiveAwardPlanMember2025-01-012025-03-310001863127us-gaap:CommonStockMemberus-gaap:PrivatePlacementMember2024-01-012024-03-310001863127us-gaap:USGovernmentAgenciesDebtSecuritiesMember2025-01-012025-03-310001863127tyra:TwentyTwentyOneEquityIncentivePlanMember2024-12-310001863127tyra:PreFundedWarrantsMember2025-01-012025-03-310001863127us-gaap:USGovernmentCorporationsAndAgenciesSecuritiesMember2024-01-012024-12-310001863127us-gaap:USTreasurySecuritiesMemberus-gaap:LongTermDebtMember2024-12-310001863127tyra:FacilitiesAndOtherCostsMembertyra:ChiefOperatingDecisionMakerMember2024-01-012024-03-310001863127us-gaap:USTreasurySecuritiesMember2025-01-012025-03-310001863127us-gaap:USGovernmentAgenciesDebtSecuritiesMember2025-03-310001863127us-gaap:AdditionalPaidInCapitalMember2025-01-012025-03-310001863127us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:LongTermDebtMember2024-01-012024-12-310001863127us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-03-310001863127us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-12-310001863127us-gaap:CommonStockMember2023-12-310001863127tyra:TwoThousandTwentyFourPrivatePlacementMemberus-gaap:PrivatePlacementMember2024-02-062024-02-0600018631272024-01-012024-12-310001863127us-gaap:ResearchAndDevelopmentExpenseMember2025-01-012025-03-310001863127us-gaap:USTreasurySecuritiesMemberus-gaap:LongTermDebtMember2025-03-3100018631272024-10-180001863127tyra:TYRA-430Membertyra:ChiefOperatingDecisionMakerMember2025-01-012025-03-310001863127tyra:FGFRDiscoveryMembertyra:ChiefOperatingDecisionMakerMember2025-01-012025-03-310001863127us-gaap:CommonStockMember2024-03-310001863127us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:LongTermDebtMember2025-01-012025-03-310001863127us-gaap:FairValueInputsLevel1Member2025-01-012025-03-310001863127tyra:AtmSalesAgreementMember2022-10-030001863127tyra:TwentyTwentyOneEquityIncentivePlanMember2025-03-310001863127tyra:BoxerCapitalLlcMembertyra:PreFundedWarrantsMember2024-10-182024-10-180001863127tyra:TwoThousandTwentyFourPrivatePlacementMembertyra:PreFundedWarrantsMember2024-02-060001863127us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2025-03-310001863127tyra:PersonnelCostsMembertyra:ChiefOperatingDecisionMakerMember2025-01-012025-03-3100018631272025-03-310001863127tyra:TwoThousandTwentyFiveSalesAgreementMember2025-05-080001863127tyra:FGFRDiscoveryMem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    

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, DC 20549

     

    FORM 10-Q

     

    (Mark One)

    ☒

    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

    For the quarterly period ended March 31, 2025

    OR

    ☐

    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

    For the transition period from _________ to _________.

    Commission File Number: 001-40800

     

    TYRA BIOSCIENCES, INC.

    (Exact Name of Registrant as Specified in its Charter)

     

     

    Delaware

    83-1476348

    (State or other jurisdiction of

    incorporation or organization)

    (I.R.S. Employer
    Identification No.)

    2656 State Street

    Carlsbad, California

    92008

    (Address of principal executive offices)

    (Zip Code)

    Registrant’s telephone number, including area code: (619) 728-4760

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class

     

    Trading

    Symbol(s)

     

    Name of each exchange on which registered

    Common Stock, $0.0001 par value per share

     

    TYRA

     

    The Nasdaq Global Select Market

     

    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

    Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

     

    Large accelerated filer

    ☐

     

    Accelerated filer

    ☐

     

     

     

     

     

    Non-accelerated filer

    ☒

     

    Smaller reporting company

    ☒

     

     

     

     

     

    Emerging growth company

    ☒

     

     

     

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

    As of May 5, 2025, the registrant had 53,177,990 shares of common stock, $0.0001 par value per share, outstanding.

     

     


    Table of Contents

     

    Page

    PART I.

    FINANCIAL INFORMATION

    Item 1.

    Condensed Financial Statements

    2

    Condensed Balance Sheets

    2

    Condensed Statements of Operations and Comprehensive Loss

    3

    Condensed Statements of Stockholders' Equity

    4

    Condensed Statements of Cash Flows

    5

    Notes to the Condensed Financial Statements

    6

    Item 2.

    Management’s Discussion and Analysis of Financial Condition and Results of Operations

    17

    Item 3.

    Quantitative and Qualitative Disclosures About Market Risk

    25

    Item 4.

    Controls and Procedures

    25

    PART II.

    OTHER INFORMATION

    Item 1.

    Legal Proceedings

    26

    Item 1A.

    Risk Factors

    26

    Item 2.

    Unregistered Sales of Equity Securities and Use of Proceeds

    26

    Item 3.

    Defaults Upon Senior Securities

    26

    Item 4.

    Mine Safety Disclosures

    26

    Item 5.

    Other Information

    26

    Item 6.

    Exhibits

    28

    Signatures

    29

     

     

    1


     

    PART I—FINANCIAL INFORMATION

    Item 1. Condensed Financial Statements

    Tyra Biosciences, Inc.
    Condensed Ba
    lance Sheets

    (in thousands, except share and per share data)

     

     

    March 31,

     

     

    December 31,

     

     

     

    2025

     

     

    2024

     

     

     

    (unaudited)

     

     

     

     

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    100,721

     

     

    $

    91,966

     

    Marketable securities

     

     

    218,222

     

     

     

    249,475

     

    Prepaid expenses and other current assets

     

     

    5,623

     

     

     

    6,022

     

    Total current assets

     

     

    324,566

     

     

     

    347,463

     

    Restricted cash

     

     

    1,000

     

     

     

    1,000

     

    Property and equipment, net

     

     

    1,522

     

     

     

    1,651

     

    Right-of-use assets

     

     

    5,946

     

     

     

    6,068

     

    Other long-term assets

     

     

    10,442

     

     

     

    7,376

     

    Total assets

     

    $

    343,476

     

     

    $

    363,558

     

    Liabilities and Stockholders’ Equity

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    2,500

     

     

    $

    590

     

    Lease liabilities, current

     

     

    426

     

     

     

    412

     

    Accrued expenses and other current liabilities

     

     

    11,320

     

     

     

    13,592

     

    Total current liabilities

     

     

    14,246

     

     

     

    14,594

     

    Lease liabilities, noncurrent

     

     

    5,696

     

     

     

    5,810

     

    Other long-term liabilities

     

     

    —

     

     

     

    3

     

    Total liabilities

     

     

    19,942

     

     

     

    20,407

     

    Commitments and contingencies (Note 10)

     

     

     

     

     

     

    Stockholders’ equity:

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 50,000,000 shares
       authorized at March 31, 2025 and December 31, 2024;
       
    no shares issued and outstanding at March 31, 2025 and
       December 31, 2024.

     

     

    —

     

     

     

    —

     

    Common stock, $0.0001 par value; 500,000,000 shares authorized
       at March 31, 2025 and December 31, 2024;
    53,089,957 and
       
    50,754,262 shares issued at March 31, 2025 and
       December 31, 2024, respectively, and
    53,089,957 and
       
    50,749,945 shares outstanding at March 31, 2025 and
       December 31, 2024, respectively.

     

     

    5

     

     

     

    5

     

    Additional paid-in capital

     

     

    602,299

     

     

     

    593,687

     

    Accumulated other comprehensive income

     

     

    688

     

     

     

    770

     

    Accumulated deficit

     

     

    (279,458

    )

     

     

    (251,311

    )

    Total stockholders’ equity

     

     

    323,534

     

     

     

    343,151

     

    Total liabilities and stockholders’ equity

     

    $

    343,476

     

     

    $

    363,558

     

     

    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)

     

     

    Three Months Ended
    March 31,

     

     

     

    2025

     

     

    2024

     

    Operating expenses:

     

     

     

     

     

     

    Research and development

     

    $

    24,964

     

     

    $

    17,203

     

    General and administrative

     

     

    6,886

     

     

     

    5,119

     

    Total operating expenses

     

     

    31,850

     

     

     

    22,322

     

    Loss from operations

     

     

    (31,850

    )

     

     

    (22,322

    )

    Other income:

     

     

     

     

     

     

    Interest and other income, net

     

     

    3,703

     

     

     

    4,130

     

    Total other income

     

     

    3,703

     

     

     

    4,130

     

    Net loss

     

     

    (28,147

    )

     

     

    (18,192

    )

    Unrealized loss on marketable securities
       available-for-sale, net

     

     

    (82

    )

     

     

    (387

    )

    Comprehensive loss

     

    $

    (28,229

    )

     

    $

    (18,579

    )

    Net loss per share, basic and diluted

     

    $

    (0.47

    )

     

    $

    (0.35

    )

    Weighted-average shares used to compute net loss
       per share, basic and diluted

     

     

    59,336,550

     

     

     

    52,228,934

     

     

    See accompanying notes to unaudited condensed financial statements.

    3


     

    Tyra Biosciences, Inc.

    Condensed Statements of Stockholders’ Equity

    (unaudited)

    (in thousands, except share amounts)

     

     

     

    Common Stock

     

     

    Additional Paid-In Capital

     

     

    Accumulated Other Comprehensive Income (Loss)

     

     

    Accumulated
    Deficit

     

     

    Total
    Stockholders’
    Equity

     

     

     

    Shares

     

     

    Amount

     

     

     

     

     

     

     

     

     

     

     

     

     

    Balance at December 31, 2023

     

     

    43,024,634

     

     

    $

    4

     

     

    $

    368,707

     

     

    $

    381

     

     

    $

    (164,830

    )

     

    $

    204,262

     

    Issuance of common stock under
       Private Placement, net of
       issuance costs of $
    0.2 million

     

     

    9,286,023

     

     

     

    1

     

     

     

    120,557

     

     

     

    —

     

     

     

    —

     

     

     

    120,558

     

    Issuance of pre-funded warrants, net
       of issuance costs of $
    0.2 million

     

     

    —

     

     

     

    —

     

     

     

    79,022

     

     

     

    —

     

     

     

    —

     

     

     

    79,022

     

    Issuance of common stock
       under benefit plans

     

     

    135,972

     

     

     

    —

     

     

     

    484

     

     

     

    —

     

     

     

    —

     

     

     

    484

     

    Vesting of shares of common
       stock subject to repurchase

     

     

    27,904

     

     

     

    —

     

     

     

    17

     

     

     

    —

     

     

     

    —

     

     

     

    17

     

    Stock-based compensation

     

     

    —

     

     

     

    —

     

     

     

    4,115

     

     

     

    —

     

     

     

    —

     

     

     

    4,115

     

    Unrealized loss on marketable
       securities available-for-sale, net

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (387

    )

     

     

    —

     

     

     

    (387

    )

    Net loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (18,192

    )

     

     

    (18,192

    )

    Balance at March 31, 2024

     

     

    52,474,533

     

     

    $

    5

     

     

    $

    572,902

     

     

    $

    (6

    )

     

    $

    (183,022

    )

     

    $

    389,879

     

     

     

     

    Common Stock

     

     

    Additional Paid-In Capital

     

     

    Accumulated Other Comprehensive Income

     

     

    Accumulated
    Deficit

     

     

    Total
    Stockholders’
    Equity

     

     

     

    Shares

     

     

    Amount

     

     

     

     

     

     

     

     

     

     

     

     

     

    Balance at December 31, 2024

     

     

    50,749,945

     

     

    $

    5

     

     

    $

    593,687

     

     

    $

    770

     

     

    $

    (251,311

    )

     

    $

    343,151

     

    Issuance of common stock pursuant to
       pre-funded warrant exercise

     

     

    2,000,069

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

    Issuance of common stock under
       benefit plans

     

     

    335,626

     

     

     

    —

     

     

     

    2,187

     

     

     

    —

     

     

     

    —

     

     

     

    2,187

     

    Vesting of shares of common
       stock subject to repurchase

     

     

    4,317

     

     

     

    —

     

     

     

    3

     

     

     

    —

     

     

     

    —

     

     

     

    3

     

    Stock-based compensation

     

     

    —

     

     

     

    —

     

     

     

    6,422

     

     

     

    —

     

     

     

    —

     

     

     

    6,422

     

    Unrealized loss on marketable
       securities available-for-sale, net

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (82

    )

     

     

    —

     

     

     

    (82

    )

    Net loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (28,147

    )

     

     

    (28,147

    )

    Balance at March 31, 2025

     

     

    53,089,957

     

     

    $

    5

     

     

    $

    602,299

     

     

    $

    688

     

     

    $

    (279,458

    )

     

    $

    323,534

     

    See accompanying notes to unaudited condensed financial statements.

    4


     

    Tyra Biosciences, Inc.

    Condensed Statements of Cash Flows

    (unaudited)

    (in thousands)

     

     

     

    Three Months Ended
    March 31,

     

     

     

    2025

     

     

    2024

     

    Cash flows from operating activities:

     

     

     

     

     

     

    Net loss

     

    $

    (28,147

    )

     

    $

    (18,192

    )

    Adjustments to reconcile net loss to net cash used in operating activities:

     

     

     

     

     

     

    Depreciation

     

     

    143

     

     

     

    122

     

    Stock-based compensation

     

     

    6,422

     

     

     

    4,115

     

    Accretion of marketable securities, net

     

     

    (866

    )

     

     

    (1,229

    )

    Changes in operating assets and liabilities:

     

     

     

     

     

     

    Prepaid expenses and other assets

     

     

    (2,667

    )

     

     

    (43

    )

    Accounts payable, accrued expenses and other liabilities

     

     

    (365

    )

     

     

    (6,906

    )

    Right-of-use assets and lease liabilities, net

     

     

    22

     

     

     

    105

     

    Net cash used in operating activities

     

     

    (25,458

    )

     

     

    (22,028

    )

    Cash flows from investing activities:

     

     

     

     

     

     

    Purchases of marketable securities

     

     

    (6,870

    )

     

     

    (11,791

    )

    Maturities of marketable securities

     

     

    38,910

     

     

     

    30,000

     

    Purchases of property and equipment

     

     

    (14

    )

     

     

    (136

    )

    Net cash provided by investing activities

     

     

    32,026

     

     

     

    18,073

     

    Cash flows from financing activities:

     

     

     

     

     

     

    Proceeds from issuances of common stock under benefit plans

     

     

    2,187

     

     

     

    484

     

    Proceeds from issuance of common stock and pre-funded warrants from Private Placement

     

     

    —

     

     

     

    200,000

     

    Payments of issuance costs for common stock and pre-funded warrants from Private Placement

     

     

    —

     

     

     

    (169

    )

    Net cash provided by financing activities

     

     

    2,187

     

     

     

    200,315

     

    Net cash increase for the period

     

     

    8,755

     

     

     

    196,360

     

    Cash, cash equivalents and restricted cash at beginning of the period

     

     

    92,966

     

     

     

    59,006

     

    Cash, cash equivalents and restricted cash at end of the period

     

    $

    101,721

     

     

    $

    255,366

     

    Reconciliation of cash, cash equivalents and restricted cash to the
       balance sheet

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    100,721

     

     

    $

    254,366

     

    Restricted cash

     

     

    1,000

     

     

     

    1,000

     

    Total cash, cash equivalents and restricted cash

     

    $

    101,721

     

     

    $

    255,366

     

    Supplemental disclosure of cash flow information:

     

     

     

     

     

     

    Non-cash investing and financing activities:

     

     

     

     

     

     

    Purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities

     

    $

    —

     

     

    $

    9

     

    Vesting of options early exercised subject to repurchase

     

    $

    3

     

     

    $

    17

     

    Issuance costs for common stock and pre-funded warrants from Private Placement included in accounts payable and accrued expenses and other current liabilities

     

    $

    —

     

     

    $

    251

     

     

    See accompanying notes to unaudited condensed financial statements.

    5


     

    Tyra Biosciences, Inc.

    Notes to the Condensed Financial Statements

    (unaudited)

    1. Organization and Summary of Significant Accounting Policies

    Organization

    Tyra Biosciences, Inc. (the Company) was incorporated in the state of Delaware on August 2, 2018. The Company is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. The Company’s in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. The Company’s initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.

    Basis of Presentation

    The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) for interim financial information and pursuant to the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB). The unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three months ended March 31, 2025 and 2024 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed balance sheet at March 31, 2025 has been derived from the financial statements at that date but does not include all disclosures required by GAAP for complete financial statements. Because all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

    Summary of Significant Accounting Policies

    During the three months ended March 31, 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).

    6


     

    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

    Marketable securities consist of debt securities of government-sponsored entities. These securities are classified as available-for sale, as the sale of such securities may be required prior to their maturity. Available-for-sale securities are recorded at fair value, with the related unrealized gains and losses included in accumulated other comprehensive income or loss and included as a separate component of stockholders' equity. The amortized cost of available-for-sale securities reflects amortization of premiums and accretion of discounts to maturity. Premiums and discounts on debt securities are amortized or accreted into interest and other income, net. The Company classifies investments in marketable debt securities as current assets, regardless of the stated maturity date, which may be beyond one year from the current balance sheet date. Short-term classification reflects management's view that the entire portfolio is available, and the Company may use the proceeds from sales of these investments to fund current operations, as necessary.

    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 March 31, 2025 and December 31, 2024 was $1.0 million, which consisted of collateral for letters of credit related to the Company’s operating leases.

    Net Loss Per Share

    Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little or no additional consideration and are fully vested and exercisable after the original issuance date of the pre-funded warrant. The Company’s potentially dilutive securities include unvested common stock upon early exercise of stock options, outstanding stock options under the Company’s equity incentive plan, and estimated shares purchasable under the employee stock purchase plan, and have been excluded from the computation of diluted net loss per share as their inclusion would be anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

    7


     

    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.

    Recently Adopted Accounting Pronouncements

    In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures", which requires public entities to make additional disclosures, primarily related to segment expenses and other segment items. The Company adopted ASU 2023-07 for the annual period ending on December 31, 2024. ASU 2023-07 did not impact the Company’s condensed financial statements. See Note 11, Segment Information, for additional disclosures.

    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 2025-0, "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, cash equivalents, marketable securities and restricted cash measured at fair value as of March 31, 2025 and December 31, 2024 (in thousands):

     

     

    March 31, 2025

     

     

    Total

     

    Quoted prices in active markets for identical assets (Level 1)

     

    Significant other observable inputs (Level 2)

     

    Significant unobservable inputs (Level 3)

     

    Cash and cash equivalents:

     

     

     

     

     

     

     

     

       Cash and money market funds

    $

    100,721

     

    $

    100,721

     

    $

    —

     

    $

    —

     

    Marketable securities:

     

     

     

     

     

     

     

     

       U.S. Treasury securities

     

    124,169

     

     

    —

     

     

    124,169

     

     

    —

     

       U.S. government agency securities

     

    94,053

     

     

    —

     

     

    94,053

     

     

    —

     

          Total marketable securities

     

    218,222

     

     

    —

     

     

    218,222

     

     

    —

     

          Total

    $

    318,943

     

    $

    100,721

     

    $

    218,222

     

    $

    —

     

     

    8


     

     

    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 and cash equivalents:

     

     

     

     

     

     

     

     

       Cash and money market funds

    $

    91,966

     

    $

    91,966

     

    $

    —

     

    $

    —

     

    Marketable securities:

     

     

     

     

     

     

     

     

       U.S. Treasury securities

     

    122,980

     

     

    —

     

     

    122,980

     

     

    —

     

       U.S. government agency securities

     

    126,495

     

     

    —

     

     

    126,495

     

     

    —

     

          Total marketable securities

     

    249,475

     

     

    —

     

     

    249,475

     

     

    —

     

          Total

    $

    341,441

     

    $

    91,966

     

    $

    249,475

     

    $

    —

     

    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):

     

    March 31, 2025

     

     

    Maturity
    (in years)

    Amortized cost

     

    Unrealized gains

     

    Unrealized losses

     

    Estimated fair value

     

    U.S. Treasury securities

    Less than one

    $

    99,985

     

    $

    248

     

    $

    (2

    )

    $

    100,231

     

    U.S. government agency securities

    Less than one

     

    61,760

     

     

    93

     

     

    (9

    )

     

    61,844

     

    U.S. Treasury securities

    1-2

     

    23,775

     

     

    163

     

     

    —

     

     

    23,938

     

    U.S. government agency securities

    1-2

     

    32,014

     

     

    195

     

     

    —

     

     

    32,209

     

    Total

     

    $

    217,534

     

    $

    699

     

    $

    (11

    )

    $

    218,222

     

     

     

    December 31, 2024

     

     

    Maturity
    (in years)

    Amortized cost

     

    Unrealized gains

     

    Unrealized losses

     

    Estimated fair value

     

    U.S. Treasury securities

    Less than one

    $

    77,990

     

    $

    210

     

    $

    (3

    )

    $

    78,197

     

    U.S. government agency securities

    Less than one

     

    94,153

     

     

    189

     

     

    (9

    )

     

    94,333

     

    U.S. Treasury securities

    1-2

     

    44,547

     

     

    239

     

     

    (3

    )

     

    44,783

     

    U.S. government agency securities

    1-2

     

    32,015

     

     

    159

     

     

    (12

    )

     

    32,162

     

    Total

     

    $

    248,705

     

    $

    797

     

    $

    (27

    )

    $

    249,475

     

    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):

     

    March 31, 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

    $

    8,002

     

     

    $

    (2

    )

     

    $

    —

     

     

    $

    —

     

     

    $

    8,002

     

     

    $

    (2

    )

    U.S. government agency securities

     

    8,378

     

     

     

    (9

    )

     

     

    —

     

     

     

    —

     

     

     

    8,378

     

     

     

    (9

    )

    Total

    $

    16,380

     

     

    $

    (11

    )

     

    $

    —

     

     

    $

    —

     

     

    $

    16,380

     

     

    $

    (11

    )

     

    9


     

     

     

    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

    $

    16,033

     

     

    $

    (6

    )

     

    $

    —

     

     

    $

    —

     

     

    $

    16,033

     

     

    $

    (6

    )

    U.S. government agency securities

     

    9,891

     

     

     

    (21

    )

     

     

    —

     

     

     

    —

     

     

     

    9,891

     

     

     

    (21

    )

    Total

    $

    25,924

     

     

    $

    (27

    )

     

    $

    —

     

     

    $

    —

     

     

    $

    25,924

     

     

    $

    (27

    )

    As of March 31, 2025, there were three available-for-sale securities with an estimated fair value of $16.4 million in gross unrealized loss positions for less than 12 months. As of March 31, 2025, unrealized losses on available-for-sale securities are not attributed to credit risk. The Company believes that an allowance for credit losses is unnecessary because the unrealized loss is due to market factors and interest rate fluctuations. Additionally, the Company does not intend to sell the securities nor is it more likely than not that the Company will be required to sell the securities before recovery of their amortized cost basis.

    The amortized cost and fair value of marketable securities excludes $1.8 million and $2.0 million of accrued interest receivable as of March 31, 2025 and December 31, 2024, respectively. Accrued interest receivable is included in prepaid expenses and other current assets on the Company's condensed balance sheets. We have not written off any accrued interest receivables for the periods ended March 31, 2025 and December 31, 2024.

    4. Property and Equipment

    Property and equipment consisted of the following (in thousands):

     

     

    March 31,
    2025

     

     

    December 31,
    2024

     

    Equipment

     

    $

    1,875

     

     

    $

    1,875

     

    Computers and software

     

     

    188

     

     

     

    205

     

    Leasehold improvements

     

     

    469

     

     

     

    469

     

    Furniture and fixtures

     

     

    383

     

     

     

    383

     

     

     

    2,915

     

     

     

    2,932

     

    Less: accumulated depreciation

     

     

    (1,393

    )

     

     

    (1,281

    )

    Total property and equipment, net

     

    $

    1,522

     

     

    $

    1,651

     

    The Company recognized $0.1 million in depreciation expense for each of the three months ended March 31, 2025 and 2024.

    5. Accrued Expenses and Other Current Liabilities

    Accrued expenses and other current liabilities consisted of the following (in thousands):

     

     

    March 31,
    2025

     

     

    December 31,
    2024

     

    Accrued payroll and other employee benefits

     

    $

    1,544

     

     

    $

    6,451

     

    Accrued research and development expenses

     

     

    9,303

     

     

     

    6,612

     

    Accrued legal and professional fees

     

     

    264

     

     

     

    296

     

    Accrued other general and administrative fees

     

     

    209

     

     

     

    233

     

    Total accrued and other current liabilities

     

    $

    11,320

     

     

    $

    13,592

     

     

    10


     

    6. Stockholders' Equity

    Common stock reserved for future issuance consisted of the following:

     

     

    March 31,
    2025

     

     

    December 31,
    2024

     

    Common stock options granted and outstanding

     

     

    10,165,576

     

     

     

    10,462,129

     

    Shares available for future issuance under the 2021
       Incentive Award Plan

     

     

    5,576,203

     

     

     

    3,051,588

     

    Shares available for future issuance under the
       2021 Employee Stock Purchase Plan

     

     

    1,972,762

     

     

     

    1,491,195

     

    Pre-funded warrants issued and outstanding

     

     

    6,381,950

     

     

     

    8,382,187

     

    Total common stock reserved for future issuance

     

     

    24,096,491

     

     

     

    23,387,099

     

    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 may, from time to time, sell shares of its common stock having an aggregate offering price of up to $150.0 million, through an “at the market” offering program. The 2022 Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the 2022 Sales Agreement. As of March 31, 2025, no shares of common stock were issued and sold pursuant to the at-the-market offering program since inception. The Company terminated the 2022 Sales Agreement in May 2025 (see Note 12 - Subsequent Events).

    On February 1, 2024, the Company entered into a securities purchase agreement for a private placement of 9,286,023 shares of the Company's common stock at a price of $13.01 per share (the 2024 Private Placement). The 2024 Private Placement also included pre-funded warrants (the 2024 Pre-Funded Warrants) to purchase an aggregate of 6,087,230 shares of common stock at a purchase price of $13.009 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable on the date of issuance and will not expire. The 2024 Private Placement closed on February 6, 2024 and the Company received gross proceeds of approximately $200.0 million, before deducting offering expenses of $0.4 million. In connection with the 2024 Private Placement, the Company issued 4,780,846 shares of common stock and pre-funded warrants to purchase 2,243,737 shares of common stock to related parties, resulting in aggregate gross proceeds of approximately $91.4 million. On March 19, 2024, the Company filed a registration statement on Form S-3 with the SEC registering the resale of the shares of common stock issued, or underlying the pre-funded warrants issued, in the 2024 Private Placement. The 2024 Pre-funded Warrants did not meet the characteristics of a liability or a derivative and are classified within stockholders' equity.

    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 2,000,000 shares of the Company’s common stock for one or more pre-funded warrants to acquire an aggregate of 2,000,000 shares of common stock and (ii) RA Capital agreed to exchange 1,000,000 shares of common stock for one or more pre-funded warrants to acquire an aggregate of 1,000,000 shares of common stock (each of such pre-funded warrants an Exchange Warrant and collectively the Exchange Warrants, and such exchanges of common stock for Exchange Warrants collectively the Exchange). Each Exchange Warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable on the date of issuance and will not expire. No cash was exchanged related to the transaction. The Exchange closed on October 22, 2024. The Exchange Warrants did not meet the characteristics of a liability or a derivative and are classified within stockholders' equity.

    During the three months ended March 31, 2025, Boxer Capital exercised 2,000,000 of the Exchange Warrants and 237 of the 2024 Pre-Funded Warrants in cashless transactions, which resulted in an aggregate of 2,000,069 shares of common stock being issued. As of March 31, 2025, a total of 6,381,950 pre-funded warrants remained available for exercise, including 1,000,000 Exchange Warrants and 5,381,950 2024 Pre-Funded Warrants.

    11


     

    7. 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) 5% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (2) such smaller amount as determined by the Company’s Board of Directors. The Company issues new shares of common stock upon exercise of options. As of March 31, 2025, 5,576,203 shares were available for future grant under the 2021 Plan.

    A summary of the Company’s stock option activity for the period ended March 31, 2025 was as follows (in thousands, except share and per share data and years):

     

     

    Options

     

     

    Weighted-Average
    Exercise
    Price per Share

     

     

    Weighted-Average
    Remaining
    Contractual Term

     

     

    Aggregate
    Intrinsic Value

     

    Outstanding at December 31, 2024

     

     

    10,462,129

     

     

    $

    13.43

     

     

     

    7.6

     

     

    $

    33,798

     

    Granted

     

     

    434,700

     

     

    $

    12.69

     

     

     

     

     

     

     

    Exercised

     

     

    (309,651

    )

     

    $

    6.24

     

     

     

     

     

     

     

    Cancelled

     

     

    (421,602

    )

     

    $

    17.14

     

     

     

     

     

     

     

    Outstanding at March 31, 2025

     

     

    10,165,576

     

     

    $

    13.46

     

     

     

    7.6

     

     

    $

    13,465

     

    Exercisable at March 31, 2025

     

     

    5,262,922

     

     

    $

    10.71

     

     

     

    6.5

     

     

    $

    12,076

     

    Vested and expected to vest as of March 31, 2025

     

     

    10,165,576

     

     

    $

    13.46

     

     

     

    7.6

     

     

    $

    13,465

     

    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). The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of common stock purchased under the ESPP is equal to 85% of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. As of March 31, 2025, there were 1,972,762 shares available for future purchase under the 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 award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following assumptions:

     

     

    Three Months Ended
    March 31,

     

     

     

    2025

     

    2024

     

    Risk-free rate of interest

     

    4.0 - 4.4%

     

    4.2%

     

    Expected term (years)

     

    5.8 - 6.1

     

    6.0 - 6.1

     

    Expected stock price volatility

     

    93.7 - 95.4%

     

    88.6%

     

    Dividend yield

     

    —

     

    —

     

     

    12


     

    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
    March 31,

     

     

     

    2025

     

     

    2024

     

    Research and development expense

     

    $

    3,678

     

     

    $

    2,475

     

    General and administrative expense

     

     

    2,744

     

     

     

    1,640

     

    Total

     

    $

    6,422

     

     

    $

    4,115

     

    The weighted-average grant date fair value of options granted for the three months ended March 31, 2025 and 2024 was $9.97 and $15.10 per share, respectively.

    For the three months ended March 31, 2025 and 2024, forfeitures resulting in the reversal of compensation expenses were immaterial.

    As of March 31, 2025, the unrecognized compensation cost related to options was $58.3 million, and is expected to be recognized as expense over a weighted-average period of approximately 2.4 years.

    As of March 31, 2025, the unrecognized compensation cost related to ESPP was $0.7 million, and is expected to be recognized as expense over a weighted-average period of approximately 1.7 years.

    8. Net Loss Per Share

    The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):

     

     

    Three Months Ended
    March 31,

     

     

     

    2025

     

     

    2024

     

    Numerator:

     

     

     

     

     

     

    Net loss

     

    $

    (28,147

    )

     

    $

    (18,192

    )

    Denominator:

     

     

     

     

     

     

    Weighted-average common shares outstanding

     

     

    59,336,550

     

     

     

    52,275,451

     

    Less: weighted-average unvested common stock issued upon early exercise of common stock options

     

     

    —

     

     

     

    (46,517

    )

    Weighted-average shares used to compute net loss per common share, basic and diluted

     

     

    59,336,550

     

     

     

    52,228,934

     

    Net loss per share, basic and diluted

     

    $

    (0.47

    )

     

    $

    (0.35

    )

    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 months ended March 31, 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 months ended March 31, 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 March 31,

     

     

     

    2025

     

     

    2024

     

    Options to purchase common stock

     

     

    10,165,576

     

     

     

    8,347,499

     

    Unvested common stock upon early exercise of stock options

     

     

    —

     

     

     

    46,517

     

    Estimated shares purchasable under the ESPP

     

     

    3,761

     

     

     

    2,913

     

     

     

    10,169,337

     

     

     

    8,396,929

     

     

    13


     

    9. Leases

    The Company has two operating leases for its office and laboratory space in Carlsbad, California that expire in November 2033. The Company has an option to renew the leases for two additional three-year periods. The Company did not include the renewal periods in determining the lease term, as the Company was not reasonably certain to exercise them.

    In connection with the Company's lease agreements, the Company paid security deposits of $0.1 million and is required to maintain a letter of credit of $1.0 million. The letter of credit may be reduced to $0.9 million in 2027 and further reduced to $0.5 million in 2028.

    Cash paid for amounts included in the measurement of lease liabilities was $0.2 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively.

    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. Components of lease cost for the three months ended March 31, 2025 and 2024, respectively, were as follows (in thousands):

     

     

    Three Months Ended
    March 31,

     

     

     

    2025

     

     

    2024

     

    Operating lease cost

     

    $

    239

     

     

    $

    239

     

    Short-term lease cost

     

     

    22

     

     

     

    24

     

    Variable lease cost

     

     

    33

     

     

     

    32

     

    Total lease cost

     

    $

    294

     

     

    $

    295

     

    Maturities of lease liabilities, weighted-average remaining term and weighted-average discount rate were as follows (in thousands):

     

     

    As of March 31,

     

    Year ending December 31,

     

     

     

    2025 (remaining nine months)

     

    $

    658

     

    2026

     

     

    900

     

    2027

     

     

    927

     

    2028

     

     

    955

     

    2029

     

     

    983

     

    Thereafter

     

     

    4,048

     

    Total minimum lease payments

     

     

    8,471

     

    Less: amount representing interest

     

     

    (2,349

    )

    Present value of lease liabilities

     

     

    6,122

     

    Less: current portion of lease liabilities

     

     

    (426

    )

    Lease liabilities, noncurrent

     

    $

    5,696

     

     

     

     

    March 31,

     

     

    December 31,

     

     

     

    2025

     

     

    2024

     

    Weighted-average remaining lease term (years) - operating leases

     

     

    8.6

     

     

     

    8.9

     

    Weighted-average incremental borrowing rate - operating leases

     

     

    8.07

    %

     

     

    8.07

    %

     

    10. Commitments and Contingencies

    Other Funding Commitments

    As of March 31, 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.

    14


     

    Litigation

    The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of March 31, 2025, and no material legal proceedings are currently pending or threatened. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss.

    11. 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 net loss (presented in the condensed statements of operations and comprehensive loss). The measure of segment assets is reported on the Balance Sheets as total assets. All long-lived assets are located in the United States.

    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
    March 31,

     

     

     

    2025

     

     

    2024

     

    Research and development expenses:

     

     

     

     

     

     

          External research and development expenses by program:

     

     

     

     

     

     

          TYRA-300ACH

     

    $

    3,587

     

     

    $

    1,405

     

          TYRA-300NMIBC

     

     

    1,290

     

     

     

    -

     

          TYRA-300mUC

     

     

    3,255

     

     

     

    4,534

     

          TYRA-430

     

     

    2,293

     

     

     

    955

     

          TYRA-200

     

     

    1,465

     

     

     

    904

     

          FGFR discovery

     

     

    3,132

     

     

     

    1,376

     

          Other development programs

     

     

    514

     

     

     

    839

     

          Unallocated research and development expenses:

     

     

     

     

     

     

          Personnel costs(1)

     

     

    8,023

     

     

     

    5,890

     

          Facilities and other costs(2)

     

     

    1,405

     

     

     

    1,300

     

    Total research and development expenses

     

     

    24,964

     

     

     

    17,203

     

    General and administrative expenses(3)

     

     

    6,886

     

     

     

    5,119

     

    Interest and other income, net

     

     

    (3,703

    )

     

     

    (4,130

    )

    Net loss

     

    $

    (28,147

    )

     

    $

    (18,192

    )

    (1) Personnel costs include $3.7 million and $2.5 million of stock-based compensation for the three months ended March 31, 2025 and 2024, respectively.

    (2) Facilities and other costs consist of research consumables, facility-related costs, depreciation and costs not attributed to a specific program.

    (3) General and administrative expenses consist of personnel-related expenses, including stock-based compensation, legal fees, facility-related costs, depreciation, professional and consulting fees and insurance costs.

    12. Subsequent Events

     

    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 common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2025 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time

    15


     

    of sale, or as otherwise agreed with the 2025 Sales Agent. The 2025 Sales Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the 2025 Sales Agreement. In connection with the 2025 Sales Agreement, the Company terminated the 2022 Sales Agreement with Virtu Americas LLC.

    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 TYRA-300, TYRA-200 and TYRA-430: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.

    Our FGFR3 Programs - TYRA-300 for Bladder Cancer and Skeletal Conditions

    Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: bladder cancer and skeletal conditions. In bladder cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth.

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    Our lead program, TYRA-300, 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 bladder cancer and skeletal conditions.

    TYRA-300 is expected to be evaluated in three Phase 2 studies: BEACH301, for the treatment of pediatric achondroplasia (ACH); SURF302, for the treatment of non-muscle invasive bladder cancer (NMIBC); and SURF301, for the treatment of metastatic urothelial carcinoma (mUC).

    BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating TYRA-300 at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with ACH with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the second quarter of 2025.

    SURF302 for NMIBC: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of TYRA-300 at lower doses (50 and 60mg QD) in participants with FGFR3-altered low-grade, intermediate risk (IR) NMIBC. We expect to dose the first patient in this study in the second quarter of 2025.

    SURF301 for mUC: This ongoing study is an international, multi-center, 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 TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In late October 2024, we reported interim data that in patients with FGFR3+ 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 TYRA-300 was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study.

    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 multi-center, open label Phase 1 clinical study, SURF201 that is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200, determine the optimal dose for further development and the MTD and RP2D, and evaluate preliminary antitumor activity, with a focus on achieving proof-of-concept in a cohort of FGFR2-driven ICC resistant to previous FGFR inhibitors.

    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.

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    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 three months ended March 31, 2025 and 2024 were $28.1 million and $18.2 million, respectively. As of March 31, 2025, we had an accumulated deficit of $279.5 million. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $318.9 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 March 31, 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.

    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:

    •
    external costs, including:
    o
    expenses incurred in connection with conducting clinical trials, including investigator grants and site payments for time and pass-through expenses and expenses incurred under agreements with contract research organizations (CROs), central laboratories and other vendors and service providers engaged to conduct our trials;
    o
    expenses incurred in connection with the discovery and preclinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
    o
    costs associated with consultants for chemistry, manufacturing and controls (CMC) development, and other services;
    o
    the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and

    19


     

    o
    costs related to compliance with drug development regulatory requirements; and
    •
    internal costs, including:
    o
    employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions;
    o
    the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and
    o
    facilities, depreciation and other indirect expenses, which include allocated expenses for rent and maintenance of facilities, and supplies.

    We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external expenses on a development program and other program-specific basis. However, we do not track internal costs on a program-specific basis because these costs primarily relate to compensation, early research and consumable costs, which are deployed across multiple programs under development.

    Research and development activities are central to our business model. There are numerous factors associated with the successful development of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates and expand our pipeline, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel.

    Our future research and development expenses may vary significantly based on a wide variety of factors, such as:

    •
    the number and scope, rate of progress, expense and results of our discovery and preclinical development activities and clinical trials;
    •
    the number of trials required for approval;
    •
    the number of sites included in each of our trials;
    •
    the countries in which the trials are conducted;
    •
    the length of time required to enroll eligible patients;
    •
    the number of patients that participate in the trials;
    •
    the ability to identify appropriate patients eligible for our clinical trials;
    •
    the number of doses that patients receive;
    •
    the drop-out or discontinuation rates of patients;
    •
    potential additional safety monitoring requested by regulatory agencies;
    •
    the duration of patient participation in the trials and follow-up;
    •
    the phase of development of the product candidate;
    •
    the efficacy and safety profile of the product candidate;

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    •
    the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
    •
    maintaining a continued acceptable safety profile of our product candidates following approval, if any;
    •
    the cost and timing of manufacturing our product candidates;
    •
    significant and changing government regulation and regulatory guidance;
    •
    the ability to attract and retain personnel;
    •
    the impact of any business interruptions to our operations or to those of the third parties with whom we work;
    •
    geopolitical instability, such as the war and other conflicts in Ukraine and the Middle East;
    •
    adverse effects on the financial markets, the global economy, the supply chain and our expenses due to pandemic or epidemic diseases, geopolitical instability, inflation, interest rates and other factors; and
    •
    the extent to which we establish additional strategic collaborations or other arrangements.

    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 consist primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.

    21


     

    Results of Operations for the Three Months Ended March 31, 2025 and 2024

    The following table summarizes our results of operations for the periods indicated (in thousands):

     

     

    Three Months Ended March 31,

     

     

     

     

     

     

    2025

     

     

    2024

     

     

    Change

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    24,964

     

     

    $

    17,203

     

     

    $

    7,761

     

    General and administrative

     

     

    6,886

     

     

     

    5,119

     

     

     

    1,767

     

    Total operating expenses

     

     

    31,850

     

     

     

    22,322

     

     

     

    9,528

     

    Loss from operations

     

     

    (31,850

    )

     

     

    (22,322

    )

     

     

    (9,528

    )

    Other income:

     

     

     

     

     

     

     

     

     

    Interest and other income, net

     

     

    3,703

     

     

     

    4,130

     

     

     

    (427

    )

    Total other income

     

     

    3,703

     

     

     

    4,130

     

     

     

    (427

    )

    Net loss

     

    $

    (28,147

    )

     

    $

    (18,192

    )

     

    $

    (9,955

    )

    Research and Development Expenses

    We track most external development costs by development program. We do not allocate internal costs, such as personnel-related expenses, stock-based compensation expense, facility, supplies and certain external consultant costs, to individual development programs.

    The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):

     

     

    Three Months Ended March 31,

     

     

     

     

     

     

    2025

     

     

    2024

     

     

    Change

     

    External research and development expenses by program:

     

     

     

     

     

     

     

     

     

    TYRA-300ACH

     

    $

    3,587

     

     

    $

    1,405

     

     

    $

    2,182

     

    TYRA-300NMIBC

     

     

    1,290

     

     

     

    —

     

     

     

    1,290

     

    TYRA-300mUC

     

     

    3,255

     

     

     

    4,534

     

     

     

    (1,279

    )

    TYRA-430

     

     

    2,293

     

     

     

    955

     

     

     

    1,338

     

    TYRA-200

     

     

    1,465

     

     

     

    904

     

     

     

    561

     

    FGFR discovery

     

     

    3,132

     

     

     

    1,376

     

     

     

    1,756

     

    Other development programs

     

     

    514

     

     

     

    839

     

     

     

    (325

    )

    Unallocated research and development expenses:

     

     

     

     

     

     

     

     

     

    Personnel costs

     

     

    8,023

     

     

     

    5,890

     

     

     

    2,133

     

    Facilities and other costs

     

     

    1,405

     

     

     

    1,300

     

     

     

    105

     

    Total research and development expenses

     

    $

    24,964

     

     

    $

    17,203

     

     

    $

    7,761

     

    Research and development expenses were $25.0 million and $17.2 million for the three months ended March 31, 2025 and 2024, respectively. The overall increase of $7.8 million was primarily driven by:

    •
    $5.6 million increase in clinical costs primarily for start-up activities related to BEACH301, SURF302 and SURF431 study launches and CMC activities; and
    •
    $2.1 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.2 million, driven by headcount growth.

    General and Administrative Expenses

    General and administrative expenses were $6.9 million and $5.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $1.8 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.1 million, driven by headcount growth.

     

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    Other Income

    Other income was $3.7 million and $4.1 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $0.4 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 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 2022 Sales Agent. As of March 31, 2025, we have not sold 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 2025 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 2025 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 2025 Sales Agent. The 2025 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.

    Cash Flows

    The following table sets forth a summary of our cash flows for the periods indicated (in thousands):

     

     

    Three Months Ended March 31,

     

     

     

     

     

     

    2025

     

     

    2024

     

     

    Change

     

    Net cash provided by (used in):

     

     

     

     

     

     

     

     

     

       Operating activities

     

    $

    (25,458

    )

     

    $

    (22,028

    )

     

    $

    (3,430

    )

       Investing activities

     

     

    32,026

     

     

     

    18,073

     

     

     

    13,953

     

       Financing activities

     

     

    2,187

     

     

     

    200,315

     

     

     

    (198,128

    )

    Net increase in cash and cash equivalents

     

    $

    8,755

     

     

    $

    196,360

     

     

    $

    (187,605

    )

    Operating Activities

    The increase of $3.4 million in net cash used in operating activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase of $10.0 million in net loss, offset by increases of $2.3 million in non-cash stock-based compensation expense, $0.4 million in non-cash net accretion on marketable securities, and changes in operating assets and liabilities of $3.9 million.

    Investing Activities

    The increase of $14.0 million in net cash provided by investing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase in maturities of marketable securities of $8.9 million, a decrease in purchases of marketable securities of $5.0 million and a decrease in purchases of property and equipment of $0.1 million.

    Financing Activities

    The decrease of $198.1 million in net cash provided by financing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to the $199.8 million in net proceeds from

    23


     

    the 2024 Private Placement received during the three months ended March 31, 2024. This decrease was partially offset by an increase of $1.7 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 TYRA-300, TYRA-430 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

    Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 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:

    •
    the initiation, type, number, scope, results, costs and timing of our ongoing and planned preclinical studies and clinical trials of existing product candidates or clinical trials of other potential product candidates we may choose to pursue in the future, including based on feedback received from regulatory authorities;
    •
    the costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing if any product candidate is approved;
    •
    the costs, timing and outcome of regulatory review of current or future product candidates;
    •
    the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
    •
    our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
    •
    the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development personnel, as well as retaining personnel;
    •
    the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved;
    •
    our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
    •
    costs associated with any products or technologies that we may in-license or acquire; and
    •
    delays or issues with any of the above, including that the risk of each may be exacerbated by any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.

    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

    24


     

    could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

    Contractual Obligations and Commitments

    Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 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 March 31, 2025, total future aggregate operating lease commitments were $8.5 million, with approximately $0.7 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 three months ended March 31, 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 March 31, 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

    25


     

    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 March 31, 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 March 31, 2025, none of our officers or directors adopted, modified or terminated any such trading arrangements.

    At the Market Sales Agreements

    2022 Sales Agreement

    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, 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 2022 Sales Agent (the 2022 ATM Offering). In connection with the 2022 ATM Offering, we filed a sales agreement prospectus (the

    26


     

    2022 ATM Prospectus) with a shelf registration statement on Form S-3 (File No. 333-267712), which was declared effective by the SEC on October 13, 2022. In connection with the 2025 Sales Agreement (defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement, and we have discontinued all offers and sales of shares of our common stock under the 2022 Sales Agreement and the 2022 ATM Prospectus. We have not sold any shares under the 2022 Sales Agreement.

    2025 Sales Agreement

    On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the 2025 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 2025 Sales Agent.

    Subject to the terms and conditions of the 2025 Sales Agreement, the 2025 Sales Agent will use commercially reasonable efforts to sell the shares from time to time, based upon our instructions. Sales of our common stock made pursuant to the 2025 Sales Agreement, if any, will be made under our shelf registration statement on Form S-3 to be filed with the SEC on May 8, 2025 (the 2025 Registration Statement), following such time as the 2025 Registration Statement is declared effective by the SEC.

    We have provided the 2025 Sales Agent with customary indemnification rights, and the 2025 Sales Agent will be entitled to a commission of up to 3.0% of the gross sales price of the shares sold through it pursuant to the 2025 Sales Agreement. The shares may be offered only by means of a prospectus forming a part of the effective 2025 Registration Statement. Sales of the shares, if any, under the 2025 Sales Agreement may be made in transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers' transactions, including on the Nasdaq Global Select Market, at market prices, or as otherwise agreed with the 2025 Sales Agent. We have no obligation to sell any shares under the 2025 Sales Agreement, and may at any time suspend offers under the 2025 Sales Agreement or terminate the 2025 Sales Agreement.

    The foregoing description of the 2025 Sales Agreement is not complete and is qualified in its entirety by reference to the 2025 Sales Agreement, a copy of which will be filed as Exhibit 1.2 to the 2025 Registration Statement and is incorporated herein by reference.

     

    27


     

    Item 6. Exhibits

    Exhibit Number

    Exhibit Description

    Incorporated by Reference

    Filed Herewith

    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.

     

    28


     

    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: May 8, 2025

    By:

    /s/ Todd Harris, Ph.D.

    Todd Harris, Ph.D.

    President, Chief Executive Officer, and Director

     

     (Principal Executive Officer)

     

     

     

     

    Date: May 8, 2025

    By:

    /s/ Alan Fuhrman

    Alan Fuhrman

    Chief Financial Officer

     

     

     

    (Principal Financial and Accounting Officer)

     

    29


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