Tyra Biosciences, Inc.: Form 10-Q for the period ended Jun 30, 2025
Filed with the SEC on Aug 14, 2025 and accepted by EDGAR at Aug 14, 2025, 16:17 ET.
Management's discussion and analysis
As filed, 36,184 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
The following discussion and analysis and the unaudited interim condensed financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2024 (the 2024 Annual Report).
Forward-Looking Statements
This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing and phase of development, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the potential benefits of regulatory designations, the timing and likelihood of regulatory filings and approvals for our product candidates, the potential to develop product candidates and the safety and therapeutic benefits of our product candidates, our ability to commercialize our product candidates, if approved, the pricing and reimbursement of our product candidates, if approved, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target” “will” or “would” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions, including, without limitation, the risk factors described in Part II, Item 1A, “Risk Factors” of this Quarterly Report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Overview
We are a clinical-stage biotechnology company focused on developing next-generation precision medicines for large opportunities in targeted oncology and genetically defined conditions, with an initial focus on Fibroblast Growth Factor Receptor (FGFR) biology.
Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP approach to develop dabogratinib (formerly TYRA-300), TYRA-430 and TYRA-200: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.
Our FGFR3 Programs - Dabogratinib for 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, dabogratinib, was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4 to minimize off-target side effects, providing potential clinical advantages over less selective first-generation compounds and potentially addressing key unmet needs across both bladder cancer and skeletal conditions.
The current planned clinical development for dabogratinib includes Phase 2 clinical studies for the treatment of non-muscle invasive bladder cancer (SURF302) and the treatment of pediatric achondroplasia (BEACH301) and potentially for the treatment of metastatic urothelial carcinoma (SURF301).
BEACH301: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating dabogratinib at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with achondroplasia (ACH) with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the third quarter of 2025.
SURF302: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, intermediate risk (IR) non-muscle invasive bladder cancer (NMIBC). The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with dabogratinib at 50 mg once daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival, progression free survival, safety and tolerability. We dosed the first patient in this study in June 2025. We expect to report initial three-month CR data in the first half of 2026.
SURF301: This ongoing study is an international, multicenter, open-label Phase 1/2 clinical trial that was designed to determine the optimal and maximum tolerated doses (MTD), and the recommended Phase 2 dose (RP2D) of dabogratinib, as well as to evaluate the preliminary antitumor activity of dabogratinib. In late October 2024, we reported interim data that in patients with FGFR3+ metastatic urothelial carcinoma (mUC) who received doses ≥ 90 mg once daily (QD), 6 out of 11 (54.5%) patients achieved a confirmed partial response. Preliminary data, as of the August 15, 2024 data cutoff, suggested dabogratinib was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study in preparation for potential future Phase 2 studies.
Our FGF19+ Program - TYRA-430 for Hepatocellular Carcinoma
FGF19 is a post-prandial enterohepatic hormone that signals through FGFR4 and its associated co-receptor Klotho Beta (KLB) to exert its normal cellular functions. In certain cancers, FGF19 is aberrantly expressed due to focal chromosomal amplifications or epigenetic mechanisms, promoting tumor cells to become dependent on the FGFR4/KLB/FGF19 oncogenic axis. Recent insights into FGF/FGFR signaling in HCC have indicated an important bypass mechanism in FGFR3, which shares the Klotho Beta coreceptor.
TYRA-430 was designed to be biased for FGFR4 and FGFR3 over the FGFR1 and FGFR2 isoforms specifically to address the FGF19 signaling pathway, while also potentially limiting side effects due to inhibition of FGFR1 and FGFR2, as well as to address acquired resistance mutations that have limited the efficacy of previous FGFR4-specific inhibitors. TYRA-430 is currently being evaluated in a global Phase 1 multicenter, open-label study, SURF431, that is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. TYRA-430 is initially being studied in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations. In April 2025, we commenced patient dosing in this study.
Our FGFR2 Program - TYRA-200 for Intrahepatic Cholangiocarcinoma
FGFR2 is a protein receptor present on the cell surface that promotes cellular proliferation and transformation upon binding of fibroblast growth factor. Activating gene alterations of FGFR2 have been implicated in the tumorigenesis of multiple solid tumor types, with pan-FGFR inhibitors approved for intrahepatic cholangiocarcinoma (ICC).
TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. TYRA-200 is currently being evaluated in a multicenter, open-label Phase 1 clinical study, SURF201 that is designed to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200, determine the optimal dose for further development and the MTD and RP2D, and evaluate preliminary antitumor activity, with a focus on achieving proof-of-concept in a cohort of FGFR2-driven ICC resistant to previous FGFR inhibitors.
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 six months ended June 30, 2025 and 2024 were $56.2 million and $36.9 million, respectively. As of June 30, 2025, we had an accumulated deficit of $307.6 million. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $296.3 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 June 30, 2025 will be sufficient to fund our operating expenses and capital expenditures through at least 2027. We have never generated any revenue and do not expect to generate any revenue from product sales unless and until we successfully complete the development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Components of Results of Operations
Operating Expenses
Research and Development Expenses
To date, our research and development expenses consist primarily of external and internal costs related to the development of our SNÅP platform and our product candidates and development programs. Our research and development expenses primarily include:
- external costs, including:
- 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;
- 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;
- costs associated with consultants for chemistry, manufacturing and controls (CMC) development, and other services;
- 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
- costs related to compliance with drug development regulatory requirements; and
- internal costs, including:
- employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions;
- the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and
- 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, such as personnel-related expenses, stock-based compensation expense, facility-related costs, and supplies, and certain external consultant costs on a program-specific basis because these costs are primarily deployed across multiple programs under development.
Research and development activities are central to our business model. There are numerous factors associated with the successful development of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates and expand our pipeline, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel.
Our future research and development expenses may vary significantly based on a wide variety of factors, such as:
- the number and scope, rate of progress, expense and results of our discovery and preclinical development activities and clinical trials;
- the number of trials required for approval;
- the number of sites included in each of our trials;
- the countries in which the trials are conducted;
- the length of time required to enroll eligible patients;
- the number of patients that participate in the trials;
- the ability to identify appropriate patients eligible for our clinical trials;
- the number of doses that patients receive;
- the drop-out or discontinuation rates of patients;
- potential additional safety monitoring requested by regulatory agencies;
- the duration of patient participation in the trials and follow-up;
- the phase of development of the product candidate;
- the efficacy and safety profile of the product candidate;
- the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
- maintaining a continued acceptable safety profile of our product candidates following approval, if any;
- the cost and timing of manufacturing our product candidates;
- significant and changing government regulation and regulatory guidance;
- the ability to attract and retain personnel;
- the impact of any business interruptions to our operations or to those of the third parties with whom we work;
- geopolitical instability, such as the war and other conflicts in Ukraine and the Middle East;
- adverse effects on the financial markets, the global economy, the supply chain and our expenses due to tariffs and trade policies, pandemic or epidemic diseases, geopolitical instability, inflation, interest rates and other factors; and
- the extent to which we establish additional strategic collaborations or other arrangements.
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate.
The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates or any future candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our product candidates or any future candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and stock-based compensation charges for personnel in executive, finance and other administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, allocated facility-related costs, professional fees for accounting, tax, business development and consulting services and insurance costs. We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company. These increased costs will likely include increased expenses related to hiring additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance costs, and investor and public relations costs.
Other Income
Other income consists primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.
Results of Operations
Comparison of the Three Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
| Operating expenses: | Three Months Ended June 30, 2025 | 2024 | Change |
|---|---|---|---|
| Research and development | $24,309 | $17,997 | $6,312 |
| General and administrative | 7,143 | 5,535 | 1,608 |
| Total operating expenses | 31,452 | 23,532 | 7,920 |
| Loss from operations | (31,452) | (23,532) | (7,920) |
| Other income: | |||
| Interest and other income, net | 3,354 | 4,830 | (1,476) |
| Total other income | 3,354 | 4,830 | (1,476) |
| Net loss | $(28,098) | $(18,702) | $(9,396) |
Research and Development Expenses
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
| External research and development expenses by program: | Three Months Ended June 30, 2025 | 2024 | Change |
|---|---|---|---|
| Dabogratinib (TYRA-300ACH) | $2,588 | $2,133 | $455 |
| Dabogratinib (TYRA-300NMIBC) | 2,436 | — | 2,436 |
| Dabogratinib (TYRA-300mUC) | 1,993 | 3,529 | (1,536) |
| TYRA-430 | 2,142 | 936 | 1,206 |
| TYRA-200 | 1,329 | 1,051 | 278 |
| FGFR discovery | 3,311 | 1,816 | 1,495 |
| Other development programs | 457 | 734 | (277) |
| Unallocated research and development expenses: | |||
| Personnel costs | 8,660 | 6,248 | 2,412 |
| Facilities and other costs | 1,393 | 1,550 | (157) |
| Total research and development expenses | $24,309 | $17,997 | $6,312 |
Research and development expenses were $24.3 million and $18.0 million for the three months ended June 30, 2025 and 2024, respectively. The overall increase of $6.3 million was primarily related to a:
- $4.1 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431 and ongoing CMC activities;
- $2.4 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.0 million, driven by headcount growth; and
- Offset by a decrease in facilities and other operating costs of $0.2 million.
General and Administrative Expenses
General and administrative expenses were $7.1 million and $5.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase of $1.6 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $0.9 million, driven by headcount growth.
Other Income
Other income was $3.4 million and $4.8 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $1.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Comparison of the Six Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
| Operating expenses: | Six Months Ended June 30, 2025 | 2024 | Change |
|---|---|---|---|
| Research and development | $49,273 | $35,199 | $14,074 |
| General and administrative | 14,029 | 10,654 | 3,375 |
| Total operating expenses | 63,302 | 45,853 | 17,449 |
| Loss from operations | (63,302) | (45,853) | (17,449) |
| Other income: | |||
| Interest and other income, net | 7,057 | 8,959 | (1,902) |
| Total other income | 7,057 | 8,959 | (1,902) |
| Net loss | $(56,245) | $(36,894) | $(19,351) |
Research and Development Expenses
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
| External research and development expenses by program: | Six Months Ended June 30, 2025 | 2024 | Change |
|---|---|---|---|
| Dabogratinib (TYRA-300ACH) | $6,175 | $3,538 | $2,637 |
| Dabogratinib (TYRA-300NMIBC) | 3,725 | — | 3,725 |
| Dabogratinib (TYRA-300mUC) | 5,248 | 8,063 | (2,815) |
| TYRA-430 | 4,436 | 1,892 | 2,544 |
| TYRA-200 | 2,794 | 1,955 | 839 |
| FGFR discovery | 6,443 | 3,193 | 3,250 |
| Other development programs | 971 | 1,570 | (599) |
| Unallocated research and development expenses: | |||
| Personnel costs | 16,683 | 12,138 | 4,545 |
| Facilities and other costs | 2,798 | 2,850 | (52) |
| Total research and development expenses | $49,273 | $35,199 | $14,074 |
Research and development expenses were $49.3 million and $35.2 million for the six months ended June 30, 2025 and 2024, respectively. The overall increase of $14.1 million was primarily related to a:
- $9.6 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431 and ongoing CMC activities; and
- $4.5 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $2.2 million, driven by headcount growth.
General and Administrative Expenses
General and administrative expenses were $14.0 million and $10.7 million for the six months ended June 30, 2025 and 2024, respectively. The increase of $3.3 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $2.0 million, driven by headcount growth.
Other Income
Other income was $7.1 million and $9.0 million for the six months ended June 30, 2025 and 2024, respectively. The decrease of $1.9 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Liquidity and Capital Resources
Sources of Liquidity
On February 6, 2024, we completed a private placement and issued 9,286,023 shares of our common stock and pre-funded warrants to purchase an aggregate of 6,087,230 shares of our common stock (the 2024 Private Placement) for net proceeds of approximately $199.6 million, excluding issuance costs of $0.4 million.
On October 3, 2022, we entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Sales Agent), under which we could have, from time to time, sold shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2022 Sales Agent. We did not sell any shares under the 2022 Sales Agreement. In connection with the 2025 Sales Agreement (as defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement.
On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale or as otherwise agreed with the Sales Agent. The Sales Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of June 30, 2025, we had not sold any shares under the 2025 Sales Agreement.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated (in thousands):
| Net cash provided by (used in): | Six Months Ended June 30, 2025 | 2024 | Change |
|---|---|---|---|
| Operating activities | $(49,138) | $(32,286) | $(16,852) |
| Investing activities | 52,892 | (126,918) | 179,810 |
| Financing activities | 2,770 | 200,688 | (197,918) |
| Net increase in cash and cash equivalents | $6,524 | $41,484 | $(34,960) |
Operating Activities
The increase of $16.9 million in net cash used in operating activities for the six months ended June 30, 2025, compared to the same period in 2024, was primarily due to an increase of $19.4 million in net loss and an increase in net changes in operating assets and liabilities of $3.3 million, offset by an increase of $4.3 million in non-cash stock-based compensation expense and a decrease of $1.5 million in non-cash net accretion on marketable securities.
Investing Activities
The increase of $179.8 million in net cash provided by investing activities for the six months ended June 30, 2025, compared to the same period in 2024, was driven by a reduction in purchases of marketable securities of $162.2 million, a $17.0 million increase in maturities of marketable securities, and a $0.6 million decrease in capital expenditures for property and equipment.
Financing Activities
The decrease of $197.9 million in net cash provided by financing activities for the six months ended June 30, 2025, compared to the same period in 2024, was primarily due to the $199.6 million in net proceeds from the 2024 Private Placement received during the six months ended June 30, 2024. This decrease was partially offset by an increase of $1.7 million in proceeds from issuances of common stock under benefit plans.
Material Cash Requirements
Our material cash requirements consist of expected operating expenses to conduct our clinical trials and other research and development activities, personnel-related expenses and operating lease obligations.
Our primary uses of cash to date have been to fund our research and development activities, including with respect to dabogratinib, TYRA-430, TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.
Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to meet our anticipated operating expenses and capital expenditures through at least 2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
Our future capital requirements will depend on many factors, including:
- the initiation, type, number, scope, results, costs and timing of our ongoing and planned preclinical studies and clinical trials of existing product candidates or clinical trials of other potential product candidates we may choose to pursue in the future, including based on feedback received from regulatory authorities;
- the costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing if any product candidate is approved;
- the costs, timing and outcome of regulatory review of current or future product candidates;
- the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
- our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
- the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development personnel, as well as retaining personnel;
- the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved;
- our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
- costs associated with any products or technologies that we may in-license or acquire; and
- delays or issues with any of the above, including that the risk of each may be exacerbated by tariffs or trade policies, any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.
Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Contractual Obligations and Commitments
Other than disclosed below, there were no material changes outside the ordinary course of our business during the six months ended June 30, 2025 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.
As of June 30, 2025, total future aggregate operating lease commitments were $8.3 million, with approximately $0.4 million due during 2025, and the remaining due in periods from 2026 through 2033.
Critical Accounting Policies and Estimates
There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2025, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.
Recently Adopted Accounting Pronouncements
See Note 1 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for recently issued accounting pronouncements that may potentially impact our financial position and results of operations.
Market risk
As filed, 375 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
As of June 30, 2025, there have been no material changes surrounding our market risk, including interest rate risk, foreign currency exchange risk, and inflation risk, from the discussion provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures about Market Risk” in the 2024 Annual Report.
Controls and procedures
As filed, 2,205 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Our management, with the participation of our chief executive officer and our chief financial officer (our principal executive officer and principal financial and accounting officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this quarterly report. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As required by SEC Rule 13a-15(b), we carried out an evaluation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on such evaluation, our chief executive officer and our chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Figures reported in this filing
Standardized line items from the XBRL in this filing, for the period ended 2025-06-30. Comparative periods it repeats are left out.
| Line item | Period | Value | XBRL concept |
|---|---|---|---|
| Research and development | 3 months2025-04-01 to 2025-06-30 | $24.3m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 6 months2025-01-01 to 2025-06-30 | $49.3m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months2025-04-01 to 2025-06-30 | −$31.5m | us-gaap:OperatingIncomeLoss |
| Operating income | 6 months2025-01-01 to 2025-06-30 | −$63.3m | us-gaap:OperatingIncomeLoss |
| Net income | 3 months2025-04-01 to 2025-06-30 | −$28.1m | us-gaap:NetIncomeLoss |
| Net income | 6 months2025-01-01 to 2025-06-30 | −$56.2m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months2025-04-01 to 2025-06-30 | −$0.47 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 6 months2025-01-01 to 2025-06-30 | −$0.95 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months2025-04-01 to 2025-06-30 | −$0.47 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 6 months2025-01-01 to 2025-06-30 | −$0.95 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months2025-04-01 to 2025-06-30 | 59,550,771 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 6 months2025-01-01 to 2025-06-30 | 59,442,646 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 6 months2025-01-01 to 2025-06-30 | −$49.1m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 6 months2025-01-01 to 2025-06-30 | $45.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | At period end2025-06-30 | $98.5m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | At period end2025-06-30 | $302.2m | us-gaap:AssetsCurrent |
| Total assets | At period end2025-06-30 | $321.5m | us-gaap:Assets |
| Current liabilities | At period end2025-06-30 | $13.8m | us-gaap:LiabilitiesCurrent |
| Total liabilities | At period end2025-06-30 | $19.4m | us-gaap:Liabilities |
| Shareholders' equity | At period end2025-06-30 | $302.1m | us-gaap:StockholdersEquity |
Source: SEC EDGAR, the filing index for accession 0000950170-25-108899. Last ingested by Listed: Oct 27, 2026, 17:31 ET. Listed shows no prices and gives no investment advice.