Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled “Forward Looking Statements and Market Data.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section entitled “Risk Factors” or in other parts of this Annual Report.
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.
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 to be evaluated in three Phase 2 studies: SURF301, for the treatment of metastatic urothelial carcinoma (mUC); SURF302, for the treatment of non-muscle invasive bladder cancer (NMIBC); and BEACH301, for the treatment of pediatric achondroplasia (ACH).
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.
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.
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 will enroll 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.
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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 will be initially studied in SURF431, a global Phase 1 multicenter, open-label, study in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431). We expect to dose the first patient in this study in the second quarter of 2025.
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 years ended December 31, 2024 and 2023 were $86.5 million and $69.1 million, respectively. As of December 31, 2024, we had an accumulated deficit of $251.3 million. As of December 31, 2024, we had cash, cash equivalents, and marketable securities of $341.4 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 December 31, 2024 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,
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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:
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external costs, including:
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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;
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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;
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costs associated with consultants for chemistry, manufacturing and controls (CMC) development, and other services;
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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
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costs related to compliance with drug development regulatory requirements; and
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internal costs, including:
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employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions;
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the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and
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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.
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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:
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the number and scope, rate of progress, expense and results of our discovery and preclinical development activities and clinical trials;
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the number of trials required for approval;
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the number of sites included in each of our trials;
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the countries in which the trials are conducted;
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the length of time required to enroll eligible patients;
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the number of patients that participate in the trials;
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the ability to identify appropriate patients eligible for our clinical trials;
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the number of doses that patients receive;
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the drop-out or discontinuation rates of patients;
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potential additional safety monitoring requested by regulatory agencies;
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the duration of patient participation in the trials and follow-up;
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the phase of development of the product candidate;
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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;
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maintaining a continued acceptable safety profile of our product candidates following approval, if any;
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the cost and timing of manufacturing our product candidates;
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significant and changing government regulation and regulatory guidance;
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the ability to attract and retain personnel;
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the impact of any business interruptions to our operations or to those of the third parties with whom we work;
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geopolitical instability, such as the war and other conflicts in Ukraine and the Middle East;
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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
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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.
Results of Operations for the Years Ended December 31, 2024 and 2023
The following table summarizes our results of operations for the periods indicated (in thousands):
Year Ended December 31,
Operating expenses:
Other income:
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.
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The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
Year Ended December 31,
External research and development expenses by program
Unallocated research and development expenses
Research and development expenses were $80.1 million and $62.5 million for the years ended December 31, 2024 and 2023, respectively. The overall increase of $17.6 million was driven by:
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$7.3 million increase in clinical costs driven by progression of SURF301 and SURF201 clinical trials and start-up activities related to BEACH301, SURF302 and SURF431 study launches;
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$1.7 million decrease in preclinical costs due to a decrease in early drug discovery and toxicology costs as various programs moved into clinical development;
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$0.3 million decrease in CMC costs for most programs in the clinical stage, except for TYRA-300ACH and certain preclinical programs;
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$10.4 million increase in compensation and other personnel expenses, including an increase in stock-based compensation costs of $6.0 million, driven by headcount growth; and
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$1.9 million increase in facilities and other operating costs due to our continuing expansion efforts.
General and Administrative Expenses
General and administrative expenses were $24.1 million and $17.4 million for the years ended December 31, 2024 and 2023, respectively. The increase of $6.7 million was driven by:
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$4.9 million increase in compensation and other personnel expenses, including an increase in stock-based compensation costs of $3.3 million, driven by headcount growth;
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$1.4 million increase in professional services, legal and other public company costs; and
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$0.4 million increase in facilities and other operating costs to support growing operations.
Other Income
Other income was $17.7 million and $10.8 million for the years ended December 31, 2024 and 2023, respectively. The increase of $6.9 million was primarily related to an increase in our cash, cash equivalents and marketable securities balances due to proceeds received from our private placement completed in February 2024.
Liquidity and Capital Resources
Sources of Liquidity
On September 17, 2021, we completed our IPO and issued 12,420,000 shares of common stock for net proceeds of approximately $181.2 million. Prior to our IPO, we funded our operations primarily through private
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placements of our convertible preferred stock with net proceeds of $157.2 million, excluding issuance costs of $0.4 million.
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 Sales Agreement) with Virtu Americas LLC (the 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 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 Agent. The Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of December 31, 2024, we have not sold any shares under the Sales Agreement.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated (in thousands):
Year Ended December 31,
Net cash used in operating activities $ (69,774 ) $ (50,139 )
Net cash used in investing activities (98,403 ) (144,605 )
Net cash provided by financing activities 202,137 1,537
Net cash increase (decrease) for the period $ 33,960 $ (193,207 )
Operating Activities
Net cash used in operating activities for the year ended December 31, 2024 was $69.8 million, consisting primarily of our net loss of $86.5 million, adjusted for $17.4 million of non-cash charges primarily related to stock-based compensation expense and accretion on marketable securities, partially offset by $0.7 million for net changes in operating assets and liabilities.
Net cash used in operating activities for the year ended December 31, 2023 was $50.1 million, consisting primarily of our net loss of $69.1 million, adjusted for $12.6 million of non-cash charges primarily related to stock-based compensation expense and accretion on marketable securities and $6.4 million for net changes in operating assets and liabilities.
Investing Activities
Net cash used in investing activities for the year ended December 31, 2024 was $98.4 million, consisting of $263.6 million for purchases of marketable securities available-for-sale and $0.7 million for purchases of property and equipment, offset by $165.9 for maturities of marketable securities available-for-sale.
Net cash used in investing activities for the year ended December 31, 2023 was $144.6 million, consisting of $143.8 million for purchases of marketable securities available-for-sale and $0.8 million for purchases of property and equipment.
Financing Activities
Net cash provided by financing activities for the year ended December 31, 2024 was $202.1 million, consisting primarily of proceeds from the issuance of common stock and pre-funded warrants from the 2024 Private Placement of $200 million, offset by issuance costs of $0.4 million, and proceeds from the issuance of common stock under benefit plans of $2.5 million.
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Net cash provided by financing activities for the year ended December 31, 2023 was $1.5 million, related to proceeds from the issuance 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, facility 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-300 ACH, 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 December 31, 2024 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:
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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;
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the costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing if any product candidate is approved;
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the costs, timing and outcome of regulatory review of current or future product candidates;
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the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
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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;
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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;
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the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved;
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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;
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costs associated with any products or technologies that we may in-license or acquire; and
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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
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potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
We lease our corporate office and laboratory space in Carlsbad, California. As of December 31, 2024, total future aggregate operating lease commitments were $8.7 million, with approximately $0.9 million due in 2025, and the remaining due in periods from 2026 through 2033. These obligations are further described in Note 10 to our audited financial statements.
In addition, we enter into agreements and purchase orders in the normal course of business with vendors for the provision of goods and services. These agreements may include certain provisions for termination, with notice, which typically consist of payments for services provided or expenses incurred through the date of cancellation. We believe that our non-cancelable obligations under these agreements are not material.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 1 to our financial statements included elsewhere in this filing, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Accrued Research and Development Expenses
Research and development expenses consist of external and internal costs associated with the Company’s research and development activities, including its discovery and research efforts and the preclinical and clinical development of its product candidates. Research and development costs are expensed in the period incurred.
The Company has entered into various research and development contracts with clinical research organizations, clinical manufacturing organizations, clinical sites and other vendors and consultants. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of or after the performance are reflected in the accompanying balance sheets as prepaid expenses or accrued liabilities, respectively. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes the progress of the services, including the phase or completion of events, invoices received and contracted costs. The Company holds discussions with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the
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Company’s estimates. Nonrefundable advance payments for goods and services, including fees for process development, are deferred and recognized as expenses in the period that the related goods are consumed or services are performed.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 1 to our financial statements appearing elsewhere in this Annual Report on Form 10-K.
Emerging Growth Company and Smaller Reporting Company Status
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (JOBS Act). We will remain an emerging growth company until the earliest to occur of: (i) the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; (ii) the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; (iii) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (iv) December 31, 2026. As a result of this status, we have taken advantage of reduced reporting requirements in this Annual Report on Form 10-K and may elect to take advantage of other reduced reporting requirements in our future filings with the SEC. In particular, in this Annual Report on Form 10-K, we have provided only two years of audited financial statements and have not included all of the executive compensation-related information that would be required if we were not an emerging growth company.
In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. We have elected to use the extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date on which we (i) are no longer an emerging growth company and (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation and other matters.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
We are exposed to market risk based on changes in interest rates. Our cash, cash equivalents and marketable securities were $341.4 million as of December 31, 2024 and consisted of cash, money market funds and securities issued by the U.S. government and its agencies. Due to the short-term nature of these instruments, we believe that we do not have any material exposure to changes in the fair value of our portfolio. However, declines in interest rates would reduce future interest income and cash flow. A hypothetical 10% relative change in interest rates during the periods presented would not have had a material impact on our financial statements.
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Foreign Currency Exchange Risk
Our expenses are generally denominated in U.S. dollars. However, we have entered into a limited number of contracts with vendors for research and development services that are denominated in foreign currencies. We are subject to foreign currency transaction gains or losses on our contracts denominated in foreign currencies. As of December 31, 2024, foreign currency transaction gains and losses have not been material to our financial statements, and we have not had a formal hedging program with respect to foreign currency. A hypothetical 10% increase or decrease in exchange rates during any of the periods presented would not have had a material impact on our financial results.
Effects of Inflation
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our financial results during the periods presented.
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Item 8. Financial Statements and Supplementary Data.
Report of Independent Registered Public Accounting Firm (PCAOB: 42) 115
Balance Sheets 116
Statements of Operations and Comprehensive Loss 117
Statements of Stockholders’ Equity 118
Statements of Cash Flows 119
Notes to Financial Statements 120
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Tyra Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Tyra Biosciences, Inc. (the Company) as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2021.
San Diego, California
March 27, 2025
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Tyra Biosciences, Inc.
Balance Sheets
(in thousands, except share and per share data)
December 31, December 31,
Assets
Current assets:
Prepaid expenses and other current assets 6,022 8,202
Liabilities and Stockholders’ Equity
Current liabilities:
Lease liabilities, current 412 280
Accrued expenses and other current liabilities 13,592 10,391
Lease liabilities, noncurrent 5,810 6,216
Other long-term liabilities 3 46
Commitments and contingencies (Note 11)
Stockholders’ equity:
Accumulated other comprehensive income 770 381
Total liabilities and stockholders’ equity $ 363,558 $ 225,857
See accompanying notes to financial statements.
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Tyra Biosciences, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Year EndedDecember 31,
Operating expenses:
Other income:
Unrealized gain on marketable securities available-for-sale, net 389 381
Net loss per share, basic and diluted $ (1.51 ) $ (1.62 )
See accompanying notes to financial statements.
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Tyra Biosciences, Inc.
Statements of Stockholders’ Equity
(in thousands, except share amounts)
Shares Amount
Vesting of shares of common stock subject to repurchase 206,488 — 124 — — 124
Unrealized gain on marketable securities available-for-sale, net — — — 381 — 381
Exchange of common stock for pre-funded warrants (3,000,000 ) — — — — —
Vesting of shares of common stock subject to repurchase 70,104 — 43 — — 43
Unrealized gain on marketable securities available-for-sale, net — — — 389 — 389
See accompanying notes to financial statements.
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Tyra Biosciences, Inc.
Statements of Cash Flows
(in thousands)
Year EndedDecember 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Accretion on marketable securities, net (5,884 ) (1,247 )
Changes in operating assets and liabilities:
Prepaid expenses and other assets (169 ) (2,823 )
Accounts payable, accrued expenses and other liabilities (744 ) 9,369
Right-of-use assets and lease liabilities, net 184 (186 )
Net cash used in operating activities (69,774 ) (50,139 )
Cash flows from investing activities:
Maturities of marketable securities 165,885 —
Purchases of property and equipment (664 ) (770 )
Net cash used in investing activities (98,403 ) (144,605 )
Cash flows from financing activities:
Proceeds from issuances of common stock under benefit plans 2,557 1,537
Net cash provided by financing activities 202,137 1,537
Net cash increase (decrease) for the period 33,960 (193,207 )
Total cash, cash equivalents and restricted cash $ 92,966 $ 59,006
Supplemental disclosure of cash flow information:
Right-of-use assets obtained in exchange for lease liabilities $ — $ 4,405
Non-cash investing and financing activities:
Vesting of options early exercised subject to repurchase $ 43 $ 124
See accompanying notes to financial statements.
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Tyra Biosciences, Inc.
Notes to the Financial Statements
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.
Since its inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. It has incurred losses and negative cash flows from operations since commencement of its operations. The Company had an accumulated deficit of $251.3 million and cash, cash equivalents and marketable securities of $341.4 million as of December 31, 2024. From its inception through December 31, 2024, the Company has financed its operations primarily through the sale of common stock, private placements of its convertible preferred stock, and the issuance of common stock and pre-funded common stock warrants through a private placement.
As the Company continues its expansion, it may seek additional financing and/or strategic investments. However, there can be no assurance that any additional financing or strategic investments will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it will most likely be required to reduce its plans and/or certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of issuance of these financial statements.
Basis of Presentation
The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).
Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Estimates and assumptions made in the accompanying financial statements include, but are not limited to, the valuation of share-based awards, the valuation of deferred tax assets and income tax uncertainties, accruals for research and development activities, and incremental borrowing rate (IBR) for right-of-use (ROU) assets. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions.
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Concentration of Credit Risk
Financial instruments which potentially subject the Company to a significant concentration of credit risk consist of cash, cash equivalents and marketable securities. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the nature of the instruments held in the depository institutions.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash equivalents primarily represent funds invested in readily available money market accounts. As of December 31, 2024, the Company had cash and cash equivalents balances deposited at major financial institutions.
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.
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:
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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).
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.
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 December 31, 2024 and 2023 was $1.0 million, which consisted of collateral for letters of credit related to the Company’s operating leases.
Property and Equipment
Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to seven years, or the remaining term of the lease).
Impairment of Long-Lived Assets
The Company accounts for the impairment of long-lived assets by reviewing these assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted-cash-flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. The Company did not recognize impairment losses for the years ended December 31, 2024 and 2023.
Accrued Research and Development Expenses
Research and development expenses consist of external and internal costs associated with the Company’s research and development activities, including its discovery and research efforts and the preclinical and clinical development of its product candidates. Research and development costs are expensed in the period incurred.
The Company has entered into various research and development contracts with clinical research organizations, clinical manufacturing organizations, clinical sites and other vendors and consultants. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of or after the performance are reflected in the accompanying balance sheets as prepaid expenses or accrued liabilities, respectively. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. The Company holds discussions with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Nonrefundable advance payments for goods and services, including fees for process
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development, are deferred and recognized as expenses in the period that the related goods are consumed or services are performed.
Patent Costs
The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the statements of operations and comprehensive loss.
Leases
The Company has operating leases for office and lab space. At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, the Company records the associated lease liability and corresponding ROU asset upon commencement of the lease using the implicit rate or a discount rate based on a credit-adjusted secured borrowing rate commensurate with the term of the lease. The Company evaluates leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease.
Operating lease assets represent a right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. Operating lease liabilities with a term greater than one year and their corresponding ROU assets are recognized on the balance sheet at the commencement date of the lease based on the present value of lease payments over the expected lease term. The Company excludes short-term leases, if any, having initial terms of 12 months or less at lease commencement as an accounting policy election.
Certain adjustments to the ROU assets may be required for items such as payments made at or before the commencement date, initial direct costs paid or lease incentives received. As the Company’s leases do not typically provide an implicit rate, the Company utilizes the appropriate IBR, determined as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and in a similar economic environment. Lease cost is recognized on a straight-line basis over the lease term and variable lease payments are recognized as operating expenses in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company. In measuring the ROU assets and lease liabilities, the Company has elected to combine lease and non-lease components.
Operating ROU assets are reflected in right-of-use assets in the accompanying balance sheets. Operating lease liabilities are reflected in lease liabilities, current and noncurrent in the accompanying balance sheets.
Common Stock Warrants
Common stock warrants are classified as either a liability or equity, based on an assessment of specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (ASC 480) and ASC 815, Derivatives and Hedging (ASC 815). The Company considers whether the warrants are freestanding financial instruments, whether they meet the definition of a liability pursuant to ASC 480, and whether they meet all of the requirements for equity classification under ASC 815. This assessment is performed at the time of warrant issuance and re-assessed as of each subsequent quarterly balance sheet date, while the warrants are outstanding.
Stock-Based Compensation
Stock-based compensation expense represents the cost of the grant date fair value of employee, officer, director and non-employee equity awards, estimated in accordance with the applicable accounting guidance, and, for those awards subject only to service conditions, recognized on a straight-line basis over the vesting period. The vesting period generally approximates the expected service period of the awards. The Company recognizes stock-based compensation expense for awards with performance conditions when it is probable that the condition will be
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met, and the award will vest. If the achievement of performance conditions is no longer deemed probable, previously recognized compensation cost is reversed. For awards with performance and service conditions, the Company begins recording share-based compensation when achieving the performance criteria is probable and recognizes the costs using the accelerated attribution method. The Company recognizes forfeitures as they occur.
The fair value of stock options is estimated using a Black-Scholes valuation model on the date of grant. This method requires certain assumptions to be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend. Options granted have a maximum contractual term of ten years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the arithmetic average of the original contractual term of the stock option and its weighted-average vesting term. The expected volatility of stock options is estimated based on the average historical volatilities of common stock of comparable publicly traded companies and the Company's own volatility. The comparable companies are chosen based on their size and stage in the life cycle. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future, and therefore, has estimated the dividend yield to be zero.
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.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the statement of operations in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
As of December 31, 2024 and 2023, the Company maintained valuation allowances against its deferred tax assets as the Company concluded it had not met the “more likely than not” to be realized threshold. Changes in the valuation allowance when they are recognized in the provision for income taxes may result in a change in the estimated annual effective tax rate.
The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to
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unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. As of December 31, 2024, the Company had no accrued interest or penalties.
Comprehensive Loss
Comprehensive loss consists of two components: net loss and other comprehensive income or loss. Other comprehensive income (loss) refers to gains or losses that are recorded as an element of stockholders’ equity but are excluded from net loss. The Company’s other comprehensive income (loss) consists of unrealized gains and losses on marketable securities.
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, 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.
Related Parties
Transactions between related parties are considered to be related party transactions even though they may not be given accounting recognition. FASB ASC 850, Related Party Disclosures (ASC 850) requires that transactions with related parties that would make a difference in decision making shall be disclosed so that users of the financial statements can evaluate their significance.
Capitalized Software Implementation Costs
The Company capitalizes certain implementation costs incurred under a cloud computing arrangement that is a service contract. Costs incurred during the application development stage related to the implementation of the hosting arrangement are capitalized and included within prepaid and other current assets, and other long-term assets on the accompanying balance sheets. Amortization of capitalized implementation costs is recognized on a straight-line basis over the term of the associated hosting arrangement when it is ready for its intended use. Costs related to preliminary project activities and post-implementation activities are expensed as incurred.
Recently Adopted Accounting Pronouncements
On August 5, 2020, the FASB issued ASU 2020-06, “Debt - Debt With Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40)”, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in GAAP. For smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2023. The Company adopted this standard effective January 1, 2024, which did not have a material impact on the Company's financial statements.
In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures". ASU 2023-07 updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for all entities for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15,
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2024. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU-2023-07, as well as all existing segments disclosures as required by ASC 280. The Company adopted this standard effective January 1, 2024 and retrospectively to all prior periods. The adoption impacted the disclosures and did not impact the financial statements. See Note 13, Segment Information, for disclosures related to the adoption of ASU 2023-07.
Issued Accounting Pronouncements Not Yet Adopted
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". ASU 2024-03 requires public entities to disclose specified information about certain costs and expenses on an interim and annual basis and is effective for annual reporting periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027, with early adoption permitted. The new standard is expected to be applied prospectively, but retrospective application is permitted. The Company is currently evaluating the impact of ASU 2024-03 on the financial statements and related disclosures.
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.
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 December 31, 2024 and 2023 (in thousands):
Cash and cash equivalents:
Cash and money market funds $ 91,966 $ 91,966 $ — $ —
Restricted cash:
Marketable securities:
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Cash and cash equivalents:
Cash and money market funds $ 58,006 $ 58,006 $ — $ —
Restricted cash:
Marketable securities:
U.S. government agency securities 49,864 — 49,864 —
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):
U.S. Treasury securities Less than one $ 76,481 $ 153 $ — $ 76,634
U.S. government agency securities Less than one 37,376 38 (3 ) 37,411
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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):
Less than 12 months 12 months or longer Total
U.S. Treasury securities $ 16,033 $ (6 ) $ — $ — $ 16,033 $ (6 )
U.S. government agency securities 9,891 (21 ) — — 9,891 (21 )
Less than 12 months 12 months or longer Total
U.S. government agency securities $ 9,939 $ (3 ) $ — $ — $ 9,939 $ (3 )
As of December 31, 2024, there were six available-for-sale securities with an estimated fair value of $25.9 million in gross unrealized loss positions for less than 12 months. As of December 31, 2024, 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 $2.0 million and $0.7 million of accrued interest receivable as of December 31, 2024 and 2023, respectively. Accrued interest receivable is included in prepaid expenses and other current assets on the Company's balance sheets. We have not written off any accrued interest receivables for the years ended December 31, 2024 and 2023.
4. Property and Equipment
Property and equipment consisted of the following (in thousands):
Less: accumulated depreciation (1,281 ) (807 )
Total property and equipment, net $ 1,651 $ 1,628
The Company recognized $0.5 million and $0.4 million in depreciation expense for the years ended December 31, 2024 and 2023, respectively.
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5. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
Accrued payroll and other employee benefits $ 6,451 $ 5,117
Accrued research and development expenses 6,612 4,848
Accrued legal and professional fees 296 132
Accrued other general and administrative fees 233 294
Total accrued and other current liabilities $ 13,592 $ 10,391
6. Stockholders' Equity
Common Stock
Common stock reserved for future issuance consisted of the following:
Pre-funded warrants issued and outstanding 8,382,187 —
On October 3, 2022, the Company entered into an ATM Sales Agreement (the Sales Agreement) with Virtu Americas LLC (the 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 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 Agent. The 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 Sales Agreement. As of December 31, 2024, no shares of common stock were issued and sold pursuant to the Sales Agreement since inception.
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 million, before deducting offering expenses of $0.4 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.
RA Capital Healthcare Fund, L.P. (RA Capital) is considered a related party to the Company because Jake Simson, Ph.D. is a member of the Company's board of directors and a partner at RA Capital. In connection with the 2024 Private Placement, the Company issued 3,180,155 shares of common stock and pre-funded warrants to purchase 1,538,457shares of the Company's common stock to RA Capital, resulting in aggregate gross proceeds of approximately $61.4 million.
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Boxer Capital, LLC (Boxer Capital) was considered a related party to the Company because, at the time of the 2024 Private Placement closing, Siddarth Subramony, Ph.D., was a member of the Company's board of directors and a managing director of Boxer Capital. Dr. Subramony subsequently resigned from the Company's board of directors on October 24, 2024. In connection with the 2024 Private Placement, the Company issued 63,412 shares of common stock and pre-funded warrants to purchase 705,280 shares of the Company's common stock to Boxer Capital, resulting in aggregate gross proceeds of approximately $10.0 million. During the year ended December 31, 2024, Boxer Capital exercised 705,043 of 2024 Pre-Funded Warrants in cashless transactions, which resulted in 705,000 shares of common stock being issued to Boxer Capital. There were no other 2024 Pre-Funded Warrant exercises during the period.
Nextech VI Oncology SCSP is considered a related party to the Company because Melissa McCracken, Ph.D., is a member of the Company's board of directors and a principal at Nextech Invest Ltd. (an affiliate of Nextech VI Oncology SCSP). In connection with the 2024 Private Placement, the Company issued 1,537,279 shares of common stock to Nextech VI Oncology SCSP, resulting in aggregate gross proceeds of approximately $20.0 million.
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 year ended December 31, 2024, there were no exercises of the Exchange Warrants.
As of December 31, 2024, a total of 8,382,187 pre-funded warrants remained available for exercise, including 3,000,000 Exchange Warrants and 5,382,187 2024 Pre-Funded Warrants. In February 2025, Boxer Capital exercised its remaining 2024 Pre-Funded Warrants and Exchange Warrants (see Note 14 - Subsequent Events). Following Boxer Capital's exercises, 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.
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 December 31, 2024, 3,051,588 shares were available for future grant under the 2021 Plan.
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A summary of the Company’s stock option activity for the year ended December 31, 2024 was as follows (in thousands, except share and per share data and years):
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 December 31, 2024, there were 1,491,195 shares available for future purchase under the ESPP.
The Company recognized compensation expense of $0.3 million and $0.5 million for the years ended December 31, 2024 and 2023, respectively, related to the ESPP. As of December 31, 2024, the remaining unrecognized compensation expense related to the ESPP was $0.4 million, and is expected to be recognized as expense over a weighted-average period of approximately 1.5 years.
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:
Year EndedDecember 31,
Risk-free rate of interest 3.5 - 4.6% 3.5 - 4.7%
Expected term (years) 5.3 - 6.1 5.2 - 6.1
Dividend yield — —
Stock-based compensation expense recognized for all equity awards has been reported in the statements of operations and comprehensive loss as follows (in thousands):
Year EndedDecember 31,
Research and development expense $ 14,291 $ 8,337
General and administrative expense 8,510 5,188
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The weighted-average grant date fair value of options granted for the years ended December 31, 2024 and 2023 was $15.95 and $9.96 per share, respectively.
During the year ended December 31, 2024, the Company entered into a transition agreement (the Transition Agreement) with its Chief Medical Officer. The Transition Agreement included accelerated vesting of 50% of unvested stock options and modified the original award terms to extend the exercise period of vested options from three months to two years from the separation date. As a result, the Company recognized an additional stock-based compensation expense of $2.0 million recorded within research and development expenses.
For the years ended December 31, 2024 and 2023, forfeitures resulting in the reversal of compensation expenses were immaterial.
As of December 31, 2024, the unrecognized compensation cost related to options was $65.1 million, and is expected to be recognized as expense over a weighted-average period of approximately 2.5 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):
Year EndedDecember 31,
Numerator:
Denominator:
Net loss per share, basic and diluted $ (1.51 ) $ (1.62 )
Included in the weighted-average shares of common stock outstanding, both basic and diluted for the year ended December 31, 2024 are weighted shares of common stock issuable upon the exercise of the 2024 Pre-Funded Warrants and the Exchange Warrants (described in Note 6). The 2024 Pre-Funded Warrants and the Exchange Warrants are exercisable at any time for nominal consideration, and therefore, these shares 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 December 31,
Unvested common stock upon early exercise of stock options 4,317 74,421
Estimated shares purchasable under the ESPP 14,280 27,035
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9. Income Taxes
The following is a reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate for the years ended December 31, 2024 and 2023 is as follows (in thousands):
Year EndedDecember 31,
Expected tax benefit at statutory rate $ (18,161 ) $ (14,518 )
State income tax, net of federal benefit (134 ) (67 )
Permanent items and other (750 ) (374 )
Provision for income taxes $ — $ —
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities as of December 31, 2024 and 2023 are as follows (in thousands):
As of December 31,
Deferred tax assets:
Deferred tax assets, net of valuation allowance 1,539 1,643
Deferred tax liabilities:
Total deferred tax liabilities (1,539 ) (1,643 )
Net deferred tax assets / (liabilities) $ — $ —
The Company has established a valuation allowance against its net deferred tax assets due to the uncertainty surrounding the realization of such assets. The Company periodically evaluates the recoverability of the deferred tax assets. At such time as it is determined that it is more likely than not that deferred assets are realizable, the valuation allowance will be reduced. The Company has recorded a full valuation allowance of $63.3 million as of December 31, 2024 as management cannot conclude that it is more likely than not that certain deferred tax assets will be realized primarily due to the history of losses from inception. The Company increased its valuation allowance by approximately $22.3 million during the year ended December 31, 2024.
At December 31, 2024, the Company had federal and state tax loss carry forwards of approximately $80.5 million and $52.2 million, respectively. As a result of the Tax Cuts and Jobs Act of 2017, for U.S. income tax purposes, net operating losses generated after December 31, 2017 can be carried forward indefinitely, but are limited to 80% utilization against future taxable income each year. Of the amount of federal and state net operating loss carryforwards, $80.5 million and $1.9 million, respectively, can be carried forward indefinitely. Unless previously utilized, certain state net operating losses will begin to expire in 2038.
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In accordance with the 2017 Tax Cuts and Jobs Act, research and experimental (R&E) expenses under Internal Revenue Code (IRC) Section 174 are required to be capitalized beginning in 2022. R&E expenses are required to be amortized over a period of five years for domestic expenses and 15 years for foreign expenses. The Company has capitalized R&E expenses in its current tax provision pursuant to the IRC Section 174.
At December 31, 2024, the Company has federal and California research and development tax credits of $11.6 million and $3.0 million, respectively. The federal research and development tax credits begin to expire in 2038 unless previously utilized.The California research and development tax credits carry forward indefinitely.
Pursuant to the IRC Sections 382 and 383, annual use of the Company’s net operating loss (NOL) and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes have occurred or occurs in the future, the amount of remaining tax attribute carryforwards available to offset taxable income and income tax expense in future years may be restricted or eliminated. If eliminated, the related asset would be removed from deferred tax assets with a corresponding reduction in the valuation allowance.
Uncertain tax positions are evaluated based upon the facts and circumstances that exist at each reporting period. Subsequent changes in judgment based upon new information may lead to changes in recognition, derecognition, and measurement. Adjustment may result, for example, upon resolution of an issue with the taxing authorities or expiration of a statute of limitations barring an assessment for an issue.
The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination by tax authorities.
The following table summarizes the changes to the Company’s gross unrecognized tax benefits for the years ended December 31, 2024 and 2023, respectively (in thousands):
Year EndedDecember 31,
Beginning balance at January 1 $ 3,006 $ 1,574
Additions related to current year positions 1,869 605
Additions related to prior year positions 654 827
Due to the existence of the valuation allowance, future recognition of previously unrecognized tax benefits will not impact the Company’s effective tax rate. The Company is subject to taxation in the United States and various state jurisdictions. All of the Company’s tax years from inception are subject to examination by federal and state tax authorities. The Company’s practice is to recognize interest and penalties related to income tax matters in income tax expense.
The Company had no accrued interest or penalties related to income tax matters in the Company’s balance sheet as of December 31, 2024 and has not recognized interest or penalties in the Company’s statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023. Further, the Company is not currently under examination by any federal, state or local tax authority.
10. Leases
The Company has operating leases for its office and laboratory space, including its corporate headquarters.
In August 2020, the Company entered into a lease agreement for approximately 4,734 square feet of office and lab space at 2656 State Street in Carlsbad, California, for the Company’s headquarters (the Original Lease). The Original Lease commenced in May 2021 and had an original term of 60 months, with an option to extend for two additional 36 month periods.
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In March 2022, the Company entered into a lease agreement for approximately 8,331 square feet of additional office and laboratory space at 2676 State Street in Carlsbad, California (the Expansion Lease). The Expansion Lease commenced for accounting purposes when the Company gained access to the premises in May 2023. The Company's obligation for payment of base rent began on the date the landlord delivered possession of the Expansion Lease premises in November 2023. The landlord completed improvements on the Expansion Lease premises, and the Company paid $0.5 million of these costs prior to the Expansion Lease commencement. The Company has concluded that the landlord is the accounting owner of these improvements, and therefore this payment was included in the calculation of the right-of-use asset and lease liability. The Company is entitled to certain rent abatement for delays related to the landlord's delivery of the Expansion Lease premises to the Company. The Expansion Lease has a lease term of 120 months, starting on the day the landlord delivered possession of the Expansion Lease premises. The Company has an option to renew the Expansion Lease for two additional 36 month periods. The Original Lease was also amended to have the same lease expiration as the Expansion Lease.
The Company did not include the renewal periods in determining the lease term, as the Company was not reasonably certain to exercise either the amended Original Lease or the Expansion Lease renewal options.
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 $0.8 million for each of the years ended December 31, 2024 and 2023.
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 statements of operations and comprehensive loss. Components of lease cost for the years ended December 31, 2024 and 2023, respectively, were as follows (in thousands):
Year EndedDecember 31,
Operating lease cost $ 957 $ 708
Short-term lease cost 90 61
Variable lease cost 127 79
Maturities of lease liabilities, weighted-average remaining term and weighted-average discount rate were as follows (in thousands):
As of December 31,
Year ending December 31,
Total minimum lease payments 8,687
Less: amount representing interest (2,465 )
Present value of lease liabilities 6,222
Less: current portion of lease liabilities (412 )
Lease liabilities, noncurrent $ 5,810
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December 31, December 31,
Weighted-average remaining lease term (years) - operating leases 8.9 9.9
Weighted-average incremental borrowing rate - operating leases 8.07 % 8.07 %
11. Commitments and Contingencies
Other Funding Commitments
As of December 31, 2024, the Company had ongoing clinical and pre-clinical studies for its various programs. The Company enters into contracts in the normal course of business with contract research organizations in preparation for clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties.
Litigation
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 December 31, 2024, 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.
12. Employee Benefits
The Company offers a 401(k) plan (401(k) Plan) for all employees who have met certain eligibility requirements. Under the 401(k) Plan, employees may elect to contribute a portion of their eligible compensation, subject to certain limitations. The Company did not make any matching employer contributions to the 401(k) Plan for the years ended December 31, 2024 and 2023.
13. 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 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.
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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 Statements of Operations and Comprehensive Loss (in thousands):
Year endedDecember 31,
Research and development expenses:
External research and development expenses by program:
Unallocated research and development expenses:
Total research and development expenses 80,077 62,518
(1) Personnel costs include $14.3 million and $8.3 million of stock-based compensation for the years ended December 31, 2024 and 2023, 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.
14. Subsequent Events
Subsequent to December 31, 2024, Exchange Warrants (as defined in Note 6) to purchase an aggregate of 2,000,000 shares of common stock and 2024 Pre-Funded Warrants (as defined in Note 6) to purchase 237 shares of common stock were exercised in cashless transactions, which resulted in an aggregate of 2,000,069 shares of common stock being issued.
Effective January 1, 2025, the Company amended its 401(k) Plan to adopt a program to match 100% of employee contributions to the 401(k) Plan up to a maximum of 4% of eligible earnings, subject to statutory limitations.
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Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure 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 December 31, 2024. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (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 Securities and Exchange Commission (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. Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our chief executive officer and our chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rules 13a-15(f). Management assessed our internal control over financial reporting as of December 31, 2024, and based its assessment on criteria established in "Internal Control - Integrated Framework (2013)" issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on that assessment, our management concluded that our internal control over financial reporting was effective as of December 31, 2024.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
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 December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Item 9B. 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 December 31, 2024, certain of our officers adopted such trading arrangements as noted below:
Trading Arrangement
* Intended to satisfy the affirmative defense of Rule 10b5-1(c)
** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)
*** Represents the maximum number of shares that may be sold pursuant to the 10b5-1 arrangement. The number of shares sold is dependent on the satisfaction of certain conditions as set forth in the written plan and the satisfaction of applicable vesting conditions of equity awards.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Information required by this item and not set forth below will be contained in our definitive proxy statement to be filed with the SEC in connection with our 2025 Annual Meeting of Stockholders (the Definitive Proxy Statement), which is expected to be filed not later than 120 days after the end of our fiscal year ended December 31, 2024, and is incorporated herein by reference.
Code of Business Conduct and Ethics
We have adopted a Code of Business Conduct and Ethics that applies to our officers, directors and employees, which is available on our website at www.tyra.bio. The Code of Business Conduct and Ethics contains general guidelines for conducting the business of our company consistent with the highest standards of business ethics and is intended to qualify as a “code of ethics” within the meaning of Section 406 of the Sarbanes-Oxley Act of 2002 and Item 406 of Regulation S-K. In addition, we intend to promptly disclose (1) the nature of any amendment to our Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar functions and (2) the nature of any waiver, including an implicit waiver, from a provision of our code of ethics that is granted to one of these
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specified officers, the name of such person who is granted the waiver and the date of the waiver on our website in the future.
Insider Trading Policy and Procedures
We have adopted an insider trading policy and procedures governing the purchase, sale, and/or other dispositions of our securities by our directors, officers, employees and other covered persons that are designed to promote compliance with insider trading laws, rules and regulations, and the Nasdaq Stock Market LLC listing rules, as applicable. A copy of our Insider Trading Compliance Policy and Procedures is filed as Exhibit 19.1 to this Annual Report. It is our policy to comply with U.S. insider trading laws and regulations, including with respect to transactions in our own securities.
Item 11. Executive Compensation.
Information required by this item will be contained in our Definitive Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Information required by this item will be contained in our Definitive Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Information required by this item will be contained in our Definitive Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services.
Information required by this item will be contained in our Definitive Proxy Statement and is incorporated herein by reference.
PART IV
Item 15. Exhibits and Financial Statement Schedules.
1.
Financial Statements.
The financial statements of Tyra Biosciences, Inc., together with the report thereon of Ernst & Young LLP, an independent registered public accounting firm (PCAOB ID No. 42), are included in this Annual Report contained in Part II, Item 8. Financial Statements and Supplementary Data.
2.
Finance Statement Schedules.
All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.
3.
Exhibits.
A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this Annual Report and is incorporated herein by reference.
Item 16. Form 10-K Summary.
None.
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EXHIBIT INDEX