05/13/2026 | Press release | Distributed by Public on 05/13/2026 06:03
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis and the unaudited interim condensed financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2025 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, 2025 (the 2025 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, harnessing the power of 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. Through this approach, we have built a wholly-owned pipeline of oral small molecule product candidates focused on targets that have previously been considered difficult-to-drug.
Our FGFR3 Programs-oral dabogratinib for Urothelial Cancers and Skeletal Dysplasia
Alterations in the protein receptor FGFR3 are a validated driver in multiple indications with large market opportunities: urothelial cancers and skeletal dysplasia conditions. In urothelial cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation. In skeletal dysplasia conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth.
Our lead program, oral 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 urothelial cancers and skeletal dysplasia conditions. To date, oral dabogratinib has been administered to over 100 participants across multiple clinical studies.
We demonstrated initial clinical proof-of-concept results with oral dabogratinib in the SURF301 study, a Phase 1 proof-of-concept study in metastatic urothelial carcinoma (mUC). Oral dabogratinib demonstrated encouraging anti-tumor activity and was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Response, safety, pharmacokinetics (PK) / pharmacodynamics (PD) and circulating tumor DNA (ctDNA) data from this study were leveraged to select doses that have the potential to achieve our target product profile for efficacy and safety in our Phase 2 trials and beyond.
We are currently advancing oral dabogratinib in three Phase 2 trials for three outsized market indications: SURF303, evaluating the treatment of low-grade upper tract urothelial carcinoma (LG-UTUC); SURF302, evaluating the treatment of intermediate risk non-muscle invasive bladder cancer (IR NMIBC); and BEACH301, evaluating the treatment of achondroplasia (ACH) in children. If we are successful with these Phase 2 studies, we expect to advance oral dabogratinib toward three potential registrational trials in LG-UTUC, IR NMIBC and ACH. We are calling this approach our "dabogratinib 3x3" strategy.
SURF303 for LG-UTUC: This open-label Phase 2a/b clinical trial was designed as a potential registrational trial to evaluate the efficacy and safety of oral dabogratinib at doses of 60 mg and 80 mg once daily (QD) in participants with FGFR3-altered low-grade upper tract urothelial carcinoma, where approximately 85% of tumors are driven by FGFR3. The Company has dosed the first patient in SURF303, with initial results expected in 2027.
SURF302 for IR NMIBC: This open-label Phase 2 clinical trial is evaluating the efficacy and safety of oral dabogratinib at 50 mg and 60 mg QD in participants with FGFR3-altered low-grade IR NMIBC, where approximately 70% of tumors are driven by FGFR3. To date, there are more than 20 patients enrolled at US and international trial sites, and the Company expects to report initial three-month complete response data from both dose cohorts in August 2026.
BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating oral dabogratinib at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg), as compared to the oncology studies, in children ages 3 to 10 with ACH with open growth plates, where approximately 99% of cases are driven by FGFR3. The study has enrolled the safety sentinel cohort, consisting of at least 3 participants per dose level in children ages 5 to 10, and is enrolling a natural history run-in for cohorts 1 and 2 with children ages 3 to 10. Initial results from the safety sentinel cohort, including 6-month average height velocity and safety data, are on-track and expected to be reported in the fourth quarter of 2026.
Our Other Programs
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 SURF431, a global, Phase 1, multicenter, open-label trial, with a focus on achieving clinical proof-of-concept in a cohort of patients with FGF19+ hepatocellular carcinoma (HCC).
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 SURF201, a global, Phase 1, multicenter, open-label trial, with a focus on achieving clinical proof-of-concept in a cohort of FGFR2-driven intrahepatic cholangiocarcinoma (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 common stock and pre-funded common stock warrants through a private placement and the issuance of common stock through an at-the-market offering program. Our net losses for the three months ended March 31, 2026 and 2025 were $39.3 million and $28.1 million, respectively. As of March 31, 2026, we had an accumulated deficit of $410.6 million. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $383.5 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 if and as we continue to develop and conduct clinical trials for our product candidates, continue our research and development activities for future product candidates, expand our clinical and regulatory capabilities, add operational and management information systems and hire additional personnel, expand and protect our intellectual property, establish marketing, sales, distribution and other commercialization capabilities if we obtain approval for any of our product candidates and incur additional costs associated with operating as a public company.
Based on our current operating plan, we believe that our cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditures into the second half of 2028. 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:
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 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 into later phases of clinical trials or 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:
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 March 31, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
Change |
||||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
33,470 |
$ |
24,964 |
$ |
8,506 |
||||||
|
General and administrative |
8,528 |
6,886 |
1,642 |
|||||||||
|
Total operating expenses |
41,998 |
31,850 |
10,148 |
|||||||||
|
Loss from operations |
(41,998 |
) |
(31,850 |
) |
(10,148 |
) |
||||||
|
Other income: |
||||||||||||
|
Interest and other income, net |
2,693 |
3,703 |
(1,010 |
) |
||||||||
|
Total other income |
2,693 |
3,703 |
(1,010 |
) |
||||||||
|
Net loss |
$ |
(39,305 |
) |
$ |
(28,147 |
) |
$ |
(11,158 |
) |
|||
Research and Development Expenses
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
Change |
||||||||||
|
External research and development expenses by program: |
||||||||||||
|
Dabogratinib LG-UTUC |
$ |
2,440 |
$ |
- |
$ |
2,440 |
||||||
|
Dabogratinib IR NMIBC |
5,248 |
1,290 |
3,958 |
|||||||||
|
Dabogratinib ACH |
4,309 |
3,587 |
722 |
|||||||||
|
Dabogratinib mUC |
1,614 |
3,255 |
(1,641 |
) |
||||||||
|
TYRA-430 HCC |
2,046 |
2,293 |
(247 |
) |
||||||||
|
TYRA-200 ICC |
1,010 |
1,465 |
(455 |
) |
||||||||
|
FGFR discovery |
2,532 |
3,132 |
(600 |
) |
||||||||
|
Other development programs |
849 |
514 |
335 |
|||||||||
|
Unallocated research and development expenses: |
||||||||||||
|
Personnel costs |
11,788 |
8,023 |
3,765 |
|||||||||
|
Facilities and other costs |
1,634 |
1,405 |
229 |
|||||||||
|
Total research and development expenses |
$ |
33,470 |
$ |
24,964 |
$ |
8,506 |
||||||
Research and development expenses were $33.5 million and $25.0 million for the three months ended March 31, 2026 and 2025, respectively. The $8.5 million increase was primarily driven by a $4.5 million increase in external costs, including a $5.5 million increase related to dabogratinib development activities supporting the ongoing BEACH301 and SURF302 clinical trials and start-up activities for SURF303, partially offset by a $1.0 million decrease in development activities for other programs. Personnel-related expenses also increased by $3.8 million, driven by headcount growth to support expanding clinical and development activities.
General and Administrative Expenses
General and administrative expenses were $8.5 million and $6.9 million for the three months ended March 31, 2026 and 2025, 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 $0.6 million, driven by headcount growth.
Other Income
Other income was $2.7 million and $3.7 million for the three months ended March 31, 2026 and 2025, respectively. The decrease of $1.0 million was driven by lower interest rates and reduced average balances in cash, cash equivalents and marketable securities prior to the receipt of proceeds under the at-the-market offering program.
Liquidity and Capital Resources
Sources of Liquidity
On May 8, 2025, we entered into a sales agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (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, in accordance with the terms of the 2025 Sales Agreement. As of March 31, 2026, 4,690,532 shares of common stock have been issued and sold pursuant to the 2025 Sales Agreement for net proceeds of approximately $147.9 million, after deducting offering expenses.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
Change |
||||||||||
|
Net cash provided by (used in): |
||||||||||||
|
Operating activities |
$ |
(32,571 |
) |
$ |
(25,458 |
) |
$ |
(7,113 |
) |
|||
|
Investing activities |
(120,244 |
) |
32,026 |
(152,270 |
) |
|||||||
|
Financing activities |
160,383 |
2,187 |
158,196 |
|||||||||
|
Net increase in cash and cash equivalents |
$ |
7,568 |
$ |
8,755 |
$ |
(1,187 |
) |
|||||
Operating Activities
The increase of $7.1 million in net cash used in operating activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to an increase of $11.2 million in net loss, offset by changes in operating assets and liabilities of $1.9 million, increases of $1.4 million in non-cash stock-based compensation expense and $0.8 million in non-cash net accretion on marketable securities.
Investing Activities
The change of $152.3 million in net cash used in investing activities for the three months ended March 31, 2026, compared to net cash provided by investing activities for the same period in 2025, was primarily driven by an increase in purchases of marketable securities of $155.3 million and a $0.1 million increase in purchases of property and equipment, partially offset by a $3.1 million increase in maturities of marketable securities.
Financing Activities
The increase of $158.2 million in net cash provided by financing activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to the $147.9 million in net proceeds from the sale of common stock under the 2025 Sales Agreement and an increase of $10.3 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 March 31, 2026 will be sufficient to meet our anticipated operating expenses and capital expenditures into the second half of 2028. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
Our future capital requirements will depend on many factors, including:
Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Contractual Obligations and Commitments
Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2026 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 2025 Annual Report.
As of March 31, 2026, total future aggregate operating lease commitments were $7.6 million, with approximately $0.7 million due during 2026, and the remaining due in periods from 2027 through 2033.
Critical Accounting Policies and Estimates
There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2026, 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 2025 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.