Tyra Biosciences(TYRA) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This part presents unaudited condensed financial statements, notes, MD&A, market risk, and controls Item 1. Condensed Financial Statements This section presents Tyra Biosciences' unaudited condensed financial statements and comprehensive notes for interim periods Condensed Balance Sheets This section provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $98,490 | $91,966 | | Marketable securities | $197,781 | $249,475 | | Total current assets | $302,155 | $347,463 | | Total assets | $321,499 | $363,558 | | Total current liabilities | $13,770 | $14,594 | | Total liabilities | $19,352 | $20,407 | | Total stockholders' equity | $302,147 | $343,151 | | Accumulated deficit | $(307,556) | $(251,311) | - Total assets decreased by $42.06 million from December 31, 2024, to June 30, 2025, primarily due to a reduction in marketable securities[10] - Accumulated deficit increased significantly from $(251.311) million to $(307.556) million, reflecting ongoing net losses[10] Condensed Statements of Operations and Comprehensive Loss This section details the company's revenues, expenses, and net loss over specific interim periods | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $24,309 | $17,997 | $49,273 | $35,199 | | General and administrative | $7,143 | $5,535 | $14,029 | $10,654 | | Total operating expenses | $31,452 | $23,532 | $63,302 | $45,853 | | Loss from operations | $(31,452) | $(23,532) | $(63,302) | $(45,853) | | Interest and other income, net | $3,354 | $4,830 | $7,057 | $8,959 | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - Net loss increased by $9.4 million (50.2%) for the three months ended June 30, 2025, compared to the same period in 2024, and by $19.35 million (52.5%) for the six months ended June 30, 2025, driven by higher operating expenses[12] - Research and development expenses increased by $6.3 million (35.1%) for the three months and $14.1 million (40.0%) for the six months ended June 30, 2025, reflecting increased clinical activities[12] Condensed Statements of Stockholders' Equity This section outlines changes in the company's equity accounts, including net loss and stock issuances - Total stockholders' equity decreased from $343.151 million at December 31, 2024, to $302.147 million at June 30, 2025, primarily due to the net loss incurred during the period[17] - Additional paid-in capital increased by $15.575 million, mainly from stock-based compensation and issuance of common stock under benefit plans[17] - The number of common shares outstanding increased from 50,749,945 at December 31, 2024, to 53,233,494 at June 30, 2025, due to warrant exercises and benefit plan issuances[17] Condensed Statements of Cash Flows This section summarizes cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(49,138) | $(32,286) | | Net cash provided by (used in) investing activities | $52,892 | $(126,918) | | Net cash provided by financing activities | $2,770 | $200,688 | | Net cash increase for the period | $6,524 | $41,484 | | Cash, cash equivalents and restricted cash at end of period | $99,490 | $100,490 | - Net cash used in operating activities increased by $16.85 million, primarily due to the higher net loss[20][112] - Investing activities shifted from a net cash outflow of $126.9 million in 2024 to a net cash inflow of $52.9 million in 2025, driven by a significant reduction in marketable securities purchases[20][113] - Financing activities provided significantly less cash in 2025 ($2.77 million) compared to 2024 ($200.69 million), as the prior year included proceeds from a large private placement[20][114][115] Notes to the Condensed Financial Statements These notes provide detailed information on accounting policies, fair value, marketable securities, equity, leases, and commitments 1. Organization and Summary of Significant Accounting Policies This note describes the company's business and the significant accounting policies applied in the financial statements - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision medicines for Fibroblast Growth Factor Receptor (FGFR) biology, utilizing its SNÅP platform for drug design[22] - The unaudited condensed financial statements are prepared in accordance with GAAP for interim financial information and SEC Form 10-Q, and should be read in conjunction with the 2024 Annual Report on Form 10-K[23] - No changes to significant accounting policies were made during the three and six months ended June 30, 2025[24] 2. Fair Value Measurements This note details the fair value hierarchy and valuation techniques used for financial assets and liabilities | Asset Category (in thousands) | June 30, 2025 Total | Level 1 | Level 2 | | :---------------------------- | :------------------ | :------ | :------ | | Money market funds | $72,922 | $72,922 | $— | | U.S. government agency securities (cash equivalents) | $2,992 | $— | $2,992 | | U.S. Treasury securities (marketable) | $110,878 | $— | $110,878| | U.S. government agency securities (marketable) | $86,903 | $— | $86,903 | | Total | $273,695 | $72,922 | $200,773| - The Company's cash equivalents and marketable securities are measured at fair value, primarily classified as Level 1 (money market funds) and Level 2 (U.S. Treasury and government agency securities) within the fair value hierarchy[25][27][36] 3. Marketable Securities This note provides details on the composition and fair value of the company's marketable securities portfolio | Marketable Securities (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :----------------------- | :--------------------------- | | U.S. Treasury securities | $110,878 | $122,980 | | U.S. government agency securities | $86,903 | $126,495 | | Total marketable securities | $197,781 | $249,475 | - Marketable securities, classified as available-for-sale, decreased by $51.69 million from December 31, 2024, to June 30, 2025[38] - As of June 30, 2025, $34.3 million of available-for-sale securities were in gross unrealized loss positions for less than 12 months, attributed to market factors and interest rate fluctuations, not credit risk[38][39] 4. Accrued Expenses and Other Current Liabilities This note details the components of accrued expenses and other current liabilities on the balance sheet | Accrued Expense Category (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accrued payroll and other employee benefits | $2,724 | $6,451 | | Accrued research and development expenses | $7,864 | $6,612 | | Accrued legal and professional fees | $209 | $296 | | Accrued other general and administrative fees | $287 | $233 | | Total accrued and other current liabilities | $11,084 | $13,592 | - Total accrued expenses and other current liabilities decreased by $2.508 million from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued payroll and other employee benefits[41] 5. Stockholders' Equity This note provides information on common stock, warrants, and shares reserved for future issuance under equity plans | Common Stock Reserved for Future Issuance | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Common stock options granted and outstanding | 10,408,456 | 10,462,129 | | Shares available for future issuance under 2021 Incentive Award Plan | 5,189,786 | 3,051,588 | | Shares available for future issuance under 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 | 23,952,954| 23,387,099 | - The Company terminated its 2022 ATM Sales Agreement and entered into a new 2025 Sales Agreement with TD Securities (USA) LLC to sell up to $150.0 million of common stock in 'at the market' offerings[42][43][109][110] - During the six months ended June 30, 2025, 2,000,069 shares of common stock were issued from the exercise of pre-funded warrants by Boxer Capital[47] 6. Equity Incentive Plans and Stock-Based Compensation This note details stock option activity and the recognition of stock-based compensation expense | Stock Option Activity | Outstanding at Dec 31, 2024 | Granted | Exercised | Cancelled | Outstanding at Jun 30, 2025 | | :-------------------- | :-------------------------- | :------ | :-------- | :-------- | :-------------------------- | | Options | 10,462,129 | 1,030,100 | (453,188) | (630,585) | 10,408,456 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expense | $3,690 | $2,658 | $7,368 | $5,133 | | General and administrative expense | $2,690 | $1,753 | $5,434 | $3,393 | | Total | $6,380 | $4,411 | $12,802 | $8,526 | - Total stock-based compensation expense increased by $1.969 million (44.6%) for the three months and $4.276 million (50.2%) for the six months ended June 30, 2025, compared to the prior year periods[52] 7. Net Loss Per Share This note explains the calculation of basic and diluted net loss per share for the periods presented | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Weighted-average common shares outstanding | 59,550,771 | 58,668,712 | 59,442,646 | 55,448,823 | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - Potentially dilutive securities, including stock options and ESPP shares, were excluded from diluted EPS calculation due to the Company's net loss position, making their inclusion anti-dilutive[32][56][57] 8. Leases This note describes the company's operating lease arrangements for office and laboratory facilities - The Company has two operating leases for office and laboratory space in Carlsbad, California, expiring in November 2033[58] | Lease Cost Component (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $239 | $239 | $478 | $478 | | Short-term lease cost | $22 | $24 | $45 | $48 | | Variable lease cost | $35 | $32 | $67 | $63 | | Total lease cost | $296 | $295 | $590 | $589 | - Total minimum lease payments as of June 30, 2025, are $8.255 million, with a weighted-average remaining lease term of 8.4 years and a weighted-average incremental borrowing rate of 8.07%[61] 9. Commitments and Contingencies This note discloses information regarding the company's contractual commitments and potential contingent liabilities - The Company has ongoing clinical and pre-clinical studies with cancellable contracts for research, consulting, and manufacturing, generally without significant cancellation penalties[62] - As of June 30, 2025, the Company was not subject to any material legal proceedings, nor were any material legal proceedings currently pending or threatened[63] 10. Segment Information This note identifies the company's operating segments and provides financial information for each segment - The Company operates as a single reportable segment, focusing on research, development, and potential commercialization of small molecule drug candidates, with the CEO acting as the chief operating decision maker (CODM)[64][65] | Research and Development Expenses by Program (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | ACH Dabogratinib (TYRA-300) | $2,588 | $2,133 | $6,175 | $3,538 | | NMIBC Dabogratinib (TYRA-300) | $2,436 | $— | $3,725 | $— | | mUC Dabogratinib (TYRA-300) | $1,993 | $3,529 | $5,248 | $8,063 | | TYRA-430 | $2,142 | $936 | $4,436 | $1,892 | | TYRA-200 | $1,329 | $1,051 | $2,794 | $1,955 | | FGFR discovery | $3,311 | $1,816 | $6,443 | $3,193 | | Other development programs | $457 | $734 | $971 | $1,570 | | Personnel costs (unallocated) | $8,660 | $6,248 | $16,683 | $12,138 | | Facilities and other costs (unallocated) | $1,393 | $1,550 | $2,798 | $2,850 | | Total Research and Development Expenses | $24,309 | $17,997 | $49,273 | $35,199 | 11. Subsequent Events This note discloses significant events that occurred after the balance sheet date but before the financial statements were issued - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, modifying corporate income tax code, including immediate expensing of domestic R&D and 100% bonus depreciation for qualified assets[68] - The Company is evaluating the OBBBA's impact but does not anticipate a material change to its effective income tax rate or net deferred federal income tax assets due to a full valuation allowance[68] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes Tyra Biosciences' financial condition, operations, expense drivers, and liquidity and capital resources Overview This section provides a general business description and strategic focus of Tyra Biosciences - Tyra Biosciences is a clinical-stage biotechnology company developing next-generation precision medicines for targeted oncology and genetically defined conditions, with an initial focus on Fibroblast Growth Factor Receptor (FGFR) biology[72] - The company utilizes its in-house SNÅP precision medicine platform for rapid and precise drug design, aiming to overcome toxicity and resistance issues of first-generation FGFR inhibitors[73] - Lead programs include dabogratinib (TYRA-300) for bladder cancer (SURF302, SURF301) and skeletal conditions (BEACH301), TYRA-430 for hepatocellular carcinoma, and TYRA-200 for intrahepatic cholangiocarcinoma, all in clinical stages[74][76][77][78][79][81][84] Financial Overview This section summarizes the company's financial performance, accumulated deficit, and liquidity position - Since inception in 2018, the Company has incurred significant operating losses, with net losses of $56.2 million and $36.9 million for the six months ended June 30, 2025 and 2024, respectively[85] - As of June 30, 2025, the accumulated deficit was $307.6 million, and cash, cash equivalents, and marketable securities totaled $296.3 million[85] - The Company expects to continue incurring significant expenses and operating losses, projecting current cash resources to fund operations through at least 2027, but anticipates needing additional financing for future development and commercialization[86][87] Components of Results of Operations This section details the Company's operating expenses (R&D, G&A) and other income, outlining their nature and future trends Research and Development Expenses This section describes the nature of R&D expenses and factors influencing their future trends - R&D expenses primarily consist of external costs for clinical trials, preclinical development, CMC, and internal costs like personnel, laboratory supplies, and facilities[88][91] - The Company expects R&D expenses to increase substantially as product candidates advance through clinical trials, new candidates are discovered, and intellectual property is expanded[90] - Future R&D expenses are highly variable, depending on factors such as trial scope, patient enrollment, regulatory approvals, manufacturing costs, and geopolitical stability[91][92][93][97] General and Administrative Expenses This section describes the nature of G&A expenses and factors influencing their future trends - G&A expenses primarily include personnel-related costs (salaries, benefits, stock-based compensation), legal fees, facility costs, and professional fees[95] - G&A expenses are expected to increase to support growing R&D activities, manufacturing, and the costs associated with operating as a public company, including hiring additional personnel and compliance[95] Other Income This section describes the sources of other income, primarily interest income from investments - Other income primarily consists of interest income from cash, cash equivalents, and marketable securities, as well as accretion income from marketable securities[96] Results of Operations This section compares the Company's financial performance for the three and six months ended June 30, 2025 and 2024 Comparison of the Three Months Ended June 30, 2025 and 2024 This section compares financial results for the three-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $24,309 | $17,997 | $6,312 | | General and administrative | $7,143 | $5,535 | $1,608 | | Interest and other income, net | $3,354 | $4,830 | $(1,476) | | Net loss | $(28,098) | $(18,702) | $(9,396) | - R&D expenses increased by $6.3 million, driven by a $4.1 million increase in clinical start-up and enrollment activities for BEACH301, SURF302, and SURF431, and a $2.4 million increase in personnel costs[99][101] - G&A expenses rose by $1.6 million, primarily due to higher compensation and personnel expenses, including a $0.9 million increase in stock-based compensation[100] - Other income decreased by $1.4 million due to lower interest rates and reduced balances in cash, cash equivalents, and marketable securities[102] Comparison of the Six Months Ended June 30, 2025 and 2024 This section compares financial results for the six-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $49,273 | $35,199 | $14,074 | | General and administrative | $14,029 | $10,654 | $3,375 | | Interest and other income, net | $7,057 | $8,959 | $(1,902) | | Net loss | $(56,245) | $(36,894) | $(19,351) | - R&D expenses increased by $14.1 million, driven by a $9.6 million increase in clinical start-up and enrollment activities for BEACH301, SURF302, and SURF431, and a $4.5 million increase in personnel costs[104][106] - G&A expenses rose by $3.3 million, primarily due to higher compensation and personnel expenses, including a $2.0 million increase in stock-based compensation[105] - Other income decreased by $1.9 million due to lower interest rates and reduced balances in cash, cash equivalents, and marketable securities[107] Liquidity and Capital Resources This section discusses the Company's cash sources, uses, liquidity, and future capital requirements Sources of Liquidity This section identifies the primary sources of cash and capital available to the company - In February 2024, the Company completed a private placement, issuing common stock and pre-funded warrants for net proceeds of approximately $199.6 million[108] - The Company terminated its 2022 ATM Sales Agreement and entered into a new 2025 Sales Agreement in May 2025, allowing for the sale of up to $150.0 million in common stock through 'at the market' offerings, with no sales made as of June 30, 2025[109][110] Cash Flows This section analyzes the changes in cash and cash equivalents from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Operating activities | $(49,138) | $(32,286) | $(16,852) | | Investing activities | $52,892 | $(126,918) | $179,810 | | Financing activities | $2,770 | $200,688 | $(197,918) | | Net increase in cash and cash equivalents | $6,524 | $41,484 | $(34,960) | - Net cash used in operating activities increased by $16.9 million, primarily due to the increased net loss[112] - Net cash provided by investing activities increased by $179.8 million, mainly due to a $162.2 million reduction in marketable securities purchases and increased maturities[113] - Net cash provided by financing activities decreased by $197.9 million, primarily due to the absence of a large private placement in 2025, which occurred in 2024[114][115] Material Cash Requirements This section outlines the company's significant future cash obligations and capital needs - The Company's primary cash uses are for R&D activities, personnel, and operating lease obligations[116][117] - Existing cash, cash equivalents, and marketable securities are believed to be sufficient to fund operations through at least 2027, but this is a forward-looking estimate subject to risks and uncertainties[118] - Future capital requirements depend on factors such as the scope and timing of clinical trials, manufacturing costs, regulatory review, intellectual property maintenance, and hiring additional personnel[119][120] Contractual Obligations and Commitments This section details the company's contractual obligations and commitments as of the reporting date - As of June 30, 2025, total future aggregate operating lease commitments were $8.3 million, with approximately $0.4 million due in the remaining six months of 2025[123] - No material changes to contractual obligations occurred during the six months ended June 30, 2025, outside the ordinary course of business[122] Critical Accounting Policies and Estimates This section discusses accounting policies and estimates requiring significant management judgment - There have been no material changes to the Company's critical accounting policies and estimates during the six months ended June 30, 2025[124] Recently Adopted Accounting Pronouncements This section outlines the impact of recently adopted accounting standards on the financial statements - The Company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03/2025-01 (Expense Disaggregation Disclosures) on its financial statements, with ASU 2023-09 effective for annual periods beginning after December 15, 2024, and ASU 2024-03 effective for annual periods beginning after December 15, 2026[34][35][125] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section addresses the Company's exposure to market risks, including interest rate, foreign currency, and inflation risks - As of June 30, 2025, there have been no material changes to the Company's market risk profile, including interest rate risk, foreign currency exchange risk, and inflation risk, compared to the disclosures in the 2024 Annual Report[126] Item 4. Controls and Procedures This section evaluates disclosure controls and procedures and reports on changes in internal control over financial reporting - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[127][128][129] - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting during the quarter ended June 30, 2025[130] PART II. OTHER INFORMATION This part provides additional information on legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings This section discloses information regarding any material legal proceedings involving the Company - The Company is not currently subject to any material legal proceedings, and no material legal proceedings are pending or threatened as of June 30, 2025[132] Item 1A. Risk Factors This section refers to risk factors that could materially affect the Company's business and financial condition - There have been no material changes to the risk factors disclosed in Item 1A of the Company's 2024 Annual Report[133] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports on any unregistered sales of equity securities and issuer repurchases of equity securities - There were no unregistered sales of equity securities or issuer repurchases of equity securities during the period[134][135] Item 3. Defaults Upon Senior Securities This section reports on any defaults upon senior securities - This item is not applicable to the Company for the reporting period[136] Item 4. Mine Safety Disclosures This section provides disclosures related to mine safety - This item is not applicable to the Company for the reporting period[137] Item 5. Other Information This section includes other information not disclosed elsewhere, such as director and officer trading arrangements - During the three months ended June 30, 2025, none of the Company's officers or directors adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[138] Item 6. Exhibits This section lists all exhibits filed as part of the 10-Q report, including corporate documents and certifications - The report includes various exhibits such as the Amended and Restated Certificate of Incorporation, Bylaws, forms of Pre-Funded and Exchange Warrants, Sales Agreement with TD Securities (USA) LLC, and certifications from the CEO and CFO[139] Signatures This section contains the required signatures of authorized officers, certifying the quarterly report filing - The report was signed on August 14, 2025, by Todd Harris, Ph.D., President, Chief Executive Officer, and Director (Principal Executive Officer), and Alan Fuhrman, Chief Financial Officer (Principal Financial and Accounting Officer)[144]