03/05/2026 | Press release | Distributed by Public on 03/05/2026 06:11
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K for the year ended December 31, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
Overview
Tango Therapeutics was founded with a clear mission: to discover the next wave of targeted therapies in oncology by addressing the specific genetic alterations that drive cancer. We leverage our state-of-the-art target and drug discovery platforms to identify novel disease-relevant targets and develop medicines tailored to defined patient populations with high unmet medical need. Our novel small molecules are designed to be selectively active in cancer cells with specific genetic alterations, killing those cancer cells while sparing normal cells. We believe our approach will provide the ability to deliver deep, durable target inhibition with favorable tolerability and safety profiles, thus potentially maximizing clinical benefit.
We are currently focused on clinical development of two MTAP-deleted selective PRMT5 inhibitors: vopimetostat (TNG462) for non-CNS cancers, both as a monotherapy and in combination with RAS inhibitors, and TNG456, our next-generation, brain-penetrant PRMT5 inhibitor, for CNS cancers, including glioblastoma (GBM).
In October 2025, we reported positive data from the ongoing Phase 1/2 clinical trial of vopimetostat monotherapy in patients with MTAP-deleted selective cancers, illustrating clinical activity across multiple cancer types with a favorable safety and tolerability profile. Specifically, the data in second-line MTAP-deleted pancreatic cancer demonstrated a median progression free survival (mPFS) of 7.2 months and 25% objective response rate (ORR), supporting the planned initiation of a 2L pivotal trial in this patient population in 2026. The histology selective cohort, which excludes sarcoma, pancreatic and lung cancer patients, also showed positive data, with a mPFS of 9.1 months and 49% ORR. We are evaluating the development path for the histology selective cohort, as well as for selected indications as stand-alone development opportunities. Lastly, emerging data from the lung cancer cohort are consistent with expectations, and we anticipate providing a safety and efficacy update in 2026.
We are focused on evaluating the combination of vopimetostat with RAS inhibitors, given the overlap in patient populations, robust preclinical data supporting potential strong combination effect in clinical trials, and favorable clinical efficacy, durability, and safety profiles observed with each drug individually. We believe this approach may enable a development path for chemotherapy-free first-line and potentially second-line therapies for MTAP-deleted/RAS-mutated patients with pancreatic and lung cancer. In June 2025, we treated the first patient in our combination clinical trial evaluating vopimetostat with the RAS(ON) multi-selective inhibitor, daraxonrasib, and RAS(ON) G12D-selective inhibitor, zoldonrasib (Revolution Medicines), which enrolled 30 patients as of December 24, 2025. Both combinations have been well-tolerated to date with exposures in the active range for all compounds with encouraging early efficacy data. We anticipate providing a safety and efficacy update from this trial in 2026. Given the differentiated profile of vopimetostat enabling the potential for efficacious and tolerable RAS inhibitor combinations, in March 2026, we entered into a clinical trial collaboration and supply agreement (CTCSA) with Erasca, Inc., or Erasca, to evaluate vopimetostat in combination with Erasca's pan-RAS molecular glue, ERAS-0015. Under the terms of the agreement, Tango is the sponsor of the trial and Erasca is supplying ERAS-0015 at no cost.
TNG456 is a brain-penetrant PRMT5 inhibitor. In May 2025, the first patient was treated with TNG456 in the dose escalation portion of the Phase 1/2 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of TNG456 as a monotherapy. The trial is currently enrolling patients with MTAP-deleted solid tumors, with a focus on GBM. We anticipate providing a safety and efficacy update from this trial in 2026.
TNG961 is a novel, potent and selective molecular glue development candidate targeting HBS1L for degradation in solid tumors in FOCAD-deleted/MTAP-deleted cancers. FOCAD deletion occurs in 20-40% of all MTAP-deleted cancers due to the collateral loss with the tumor suppressor gene CDKN2A/B on chromosome 9p21. Cancers with FOCAD loss are dependent on HBS1L for mRNA processing, thus protein synthesis. By degrading HBS1L and disrupting the HBS1L/PELO complex, TNG961 causes tumor regression in FOCAD-deleted preclinical models of multiple histologies. TNG961 is in the IND-enabling phase of development.
TNG260 is a first-in-class CoREST inhibitor. In November 2025, we announced that patients with checkpoint inhibitor resistant STK11 mutant/KRAS wild-type NSCLC receiving clinically active doses of TNG260 plus pembrolizumab had a mPFS of 29 weeks (n=5), more than double the standard of care PFS of ~10 weeks. 80 mg QD of TNG260 was selected for dose expansion, which is ongoing for patients.
Financial Overview
Since the Company's inception, we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering product candidates, securing related intellectual property, and conducting research and development activities for our programs. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Through December 31, 2025, we have raised an aggregate of $1.1 billion from such transactions, including $857.0 million in aggregate gross proceeds from the sale of preferred shares, the closing of our Business Combination, follow-on public and private offerings, and through our "at-the-market" stock offering programs, and $237.1 million through our collaboration with Gilead. Additionally, during the first quarter of 2026, and through March 2, 2026, we have received gross proceeds of $62.1 million from our "at-the-market" stock offering program.
We expect that our existing cash, cash equivalents and marketable securities on hand as of December 31, 2025 of $343.1 million, will enable us to fund our operating expenses and capital expenditure requirements into 2028. Since inception, we have incurred significant operating losses. For the years ended December 31, 2025, 2024, and 2023 our net losses were $101.6 million, $130.3 million, and $101.7 million, respectively. We had an accumulated deficit of $603.2 million as of December 31, 2025. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, and maintain and expand our intellectual property portfolio. We also expect to hire additional personnel, incur accounting, audit, legal, regulatory, consulting, and other costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, our clinical trials, and our expenditures on other research and development activities.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates, if ever. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements, as and when needed, could have a negative effect on our business, results of operations and financial condition.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenues from the sale of our therapies, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
Liquidity and Capital Resources
In October 2025, we completed an underwritten offering and a concurrent private placement for the issuance of a total of 22,755,438 shares of common stock at a price of $8.66 per share and pre-funded warrants to purchase 3,226,458 shares of common stock at a purchase price of $8.659 per pre-funded warrant, resulting in gross proceeds of $225.0 million. The pre-funded warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and will remain exercisable until exercised in full. After deducting expenses related to the offering and private placement of $13.2 million, net proceeds were $211.8 million. Both transactions closed on October 24, 2025. Net proceeds from all financing activities will be used to advance our pipeline and for working capital and other general corporate purposes.
In November 2025, we entered into a sales agreement (the Leerink Sales Agreement) with Leerink Partners LLC (Leerink) which permitted us to sell from time to time, at its option, up to an aggregate of $100.0 million of shares of its common stock through Leerink, as sales agent. Sales of the common stock, if any, will be made by methods deemed to be "at-the-market" stock offerings. The Leerink Sales Agreement will terminate upon the earliest of: (a) the sale of $100.0 million of shares of the Company's common stock or (b) the termination of the Leerink Sales Agreement by the Company or Leerink. As of March 2, 2026, we had sold 4,953,078 shares of common stock under this stock offering program for gross proceeds of $62.1 million.
In September 2022, we entered into a sales agreement (the Jefferies Sales Agreement) with Jefferies LLC (Jefferies) which permitted us to sell shares of our common stock through Jefferies, as sales agent. In November 2025, the Jefferies Sales Agreement was terminated. At the time of the termination of the Jefferies Sales Agreement, we had sold 4,001,200 shares of common stock under this stock offering program for gross proceeds of $43.0 million.
Revenue
To date, we have not recognized any revenue from product sales, and we do not expect to generate any revenue from the sale of products in the next several years. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Collaboration Agreements with Gilead Sciences
In October 2018, we entered into a collaboration agreement (the 2018 Gilead Agreement) with Gilead Sciences, Inc. (Gilead), under which we received an initial upfront payment of $50.0 million. In August 2020, the 2018 Gilead Agreement was expanded into a broader collaboration via an amended and restated research collaboration and license agreement (the Gilead Agreement), under which we received an upfront payment of $125.0 million. Upfront payments totaling $175.0 million and subsequent research extension fees totaling $24.0 million were recorded as deferred revenue on our balance sheet and recognized as revenue as or when the performance obligation under the contract was satisfied. In June 2024, Gilead licensed a program for a $12.0 million fee, which was recognized as license revenue in the second quarter of 2024.
In August 2025, the Company and Gilead mutually agreed to truncate the research term of the collaboration and license agreement from seven to five years, concluding the research portion of the collaboration. There was no financial penalty to the Company as a result, no licensed programs were returned to the Company, all ongoing work at Gilead on licensed programs will continue and agreements for all future milestones and royalties remain in effect. The Company has no future research obligations and the remaining unrecognized deferred revenue balance at the time of truncating the collaboration agreement of $53.8 million was recognized as revenue in the third quarter of 2025.
As of December 31, 2025, all $199.0 million has been recognized as collaboration revenue related to the upfront and research option-extension payments from the Gilead Agreements.
During the years ended December 31, 2025, 2024, and 2023, we recognized $62.4 million, $30.0 million, and $31.5 million, respectively, of collaboration revenue associated with the Gilead agreements based on performance completed during each period.
Refer to Note 2 and Note 3 to our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information regarding our revenue recognition accounting policy and our collaboration agreement with Gilead.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our drug discovery efforts and the development of our product candidates. We expense research and development costs as incurred, which include:
Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical studies or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.
Our direct external research and development expenses consist primarily of fees paid to CROs, as well as outside vendors and consultants in connection with our preclinical and clinical development and manufacturing activities. We track these external research and development costs on a program-by-program basis once we have identified a product candidate.
We do not allocate employee costs or costs associated with our target discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We characterize research and development costs incurred prior to the identification of a product candidate as discovery costs. We use internal resources primarily to conduct our research and discovery activities as well as for managing our preclinical, development and manufacturing activities.
The following table summarizes our research and development expenses:
|
Year Ended December 31, |
||||||||
|
2025 |
2024 |
|||||||
|
(in thousands) |
||||||||
|
vopimetostat direct program expenses |
$ |
26,522 |
$ |
16,161 |
||||
|
TNG456 direct program expenses |
6,557 |
4,531 |
||||||
|
TNG260 direct program expenses |
6,278 |
9,382 |
||||||
|
TNG961 direct program expenses |
5,675 |
- |
||||||
|
TNG908 direct program expenses* |
5,027 |
13,587 |
||||||
|
TNG348 direct program expenses** |
- |
5,476 |
||||||
|
Discovery direct program expenses |
10,167 |
24,440 |
||||||
|
Unallocated research and development expenses: |
||||||||
|
Personnel-related expenses |
51,474 |
51,457 |
||||||
|
Facilities and other related expenses |
20,465 |
18,884 |
||||||
|
Total research and development expenses |
$ |
132,165 |
$ |
143,918 |
||||
*In November 2024, we announced we stopped enrollment in the TNG908 Phase 1/2 trial due to insufficient brain exposure for GBM clinical activity and portfolio prioritization. Expenses beyond November 2024 related to previously enrolled patients and close-out clinical trial costs.
**In May 2024, we announced the discontinuation of TNG348, a USP1 inhibitor, due to toxicity observed in the dose escalation portion of our Phase 1/2 clinical trial. Expenses beyond May 2024 related to close-out clinical trial costs.
The successful development of our product candidates is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates or the timing of regulatory filings in connection with clinical trials or regulatory approval, due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines,
the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate's commercial potential. Our clinical development costs have, and are expected to continue to, increase significantly with the commencement and continuation of our current and planned clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of employee related costs, including salaries, bonuses, benefits, stock-based compensation and other related costs. General and administrative expense also includes professional services, including legal, accounting and audit services and other consulting fees as well as facility costs not otherwise included in research and development expenses, insurance and other general administrative expenses.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.
Other Income, Net
Interest Income
Interest income consists of income earned and losses incurred in connection with our investments in money market funds, U.S. Treasury bills and U.S. government agency bonds.
Other Income, Net
Other income, net consists of miscellaneous income and expense unrelated to our core operations.
Provision for Income Taxes
Our provision for income tax consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. We recorded an insignificant provision for income taxes for each of the years ended December 31, 2025 and 2024.
Results of Operations
Comparison of the Years Ended December 31, 2025 and 2024
The following table summarizes our results of operations for the years ended December 31, 2025 and 2024:
|
Year Ended December 31, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(in thousands) |
||||||||||||
|
Collaboration revenue |
$ |
62,384 |
$ |
29,969 |
$ |
32,415 |
||||||
|
License revenue |
- |
12,100 |
(12,100 |
) |
||||||||
|
Total revenue |
62,384 |
42,069 |
20,315 |
|||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
132,165 |
143,918 |
(11,753 |
) |
||||||||
|
General and administrative |
41,508 |
43,746 |
(2,238 |
) |
||||||||
|
Total operating expenses |
173,673 |
187,664 |
(13,991 |
) |
||||||||
|
Loss from operations |
(111,289 |
) |
(145,595 |
) |
34,306 |
|||||||
|
Other income: |
||||||||||||
|
Interest income |
5,630 |
7,890 |
(2,260 |
) |
||||||||
|
Other income, net |
4,069 |
7,611 |
(3,542 |
) |
||||||||
|
Total other income, net |
9,699 |
15,501 |
(5,802 |
) |
||||||||
|
Loss before income taxes |
(101,590 |
) |
(130,094 |
) |
28,504 |
|||||||
|
Provision for income taxes |
(4 |
) |
(208 |
) |
204 |
|||||||
|
Net loss |
$ |
(101,594 |
) |
$ |
(130,302 |
) |
$ |
28,708 |
||||
Collaboration Revenue
Collaboration revenue of $62.4 million and $30.0 million for the years ended December 31, 2025 and 2024, respectively, was derived from the Gilead collaboration. All remaining deferred revenue from the upfront and research option-extension payments under the collaboration were recognized as revenue during the year ended December 31, 2025 as a result of the truncation of the collaboration agreement which concluded all research activities.
License Revenue
License revenue was $0 and $12.1 million for the years ended December 31, 2025 and 2024, respectively. The revenue recognized during the second quarter of 2024 was primarily due to licensing a program to Gilead for $12.0 million during the period.
Research and Development Expenses
Research and development expense was $132.2 million for the year ended December 31, 2025 compared to $143.9 million for the year ended December 31, 2024. The decrease of $11.7 million was mainly driven by a $14.0 million decrease due to the discontinuation of the TNG908 and TNG348 clinical programs, a $3.1 million decrease in TNG260 clinical trial costs and lower discovery program expenses. This decrease was partially offset by increased spend related to the advancement of the vopimetostat, TNG456 and TNG961 clinical programs.
General and Administrative Expenses
General and administrative expense was $41.5 million for the year ended December 31, 2025 compared to $43.7 million for the year ended December 31, 2024. The decrease of $2.2 million was primarily due to a decrease in personnel-related costs, including share-based compensation expense.
Interest Income
Interest income was $5.6 million for the year ended December 31, 2025 compared to $7.9 million for the year ended December 31, 2024. The decrease of $2.3 million was primarily due to a higher average portfolio balance in 2024 compared to 2025 combined with declining rates throughout 2025.
Other Income, Net
Other income, net was $4.1 million for the year ended December 31, 2025 compared to $7.6 million for the year ended December 31, 2024, with the decrease primarily attributed to lower accretion from investments purchased at a discount.
Provision for Income Taxes
Provision for income taxes was less than $0.1 million for the year ended December 31, 2025 compared to $0.2 million for the year ended December 31, 2024. The income tax provision amount for both periods is primarily attributable to state taxes on interest income earned on marketable securities.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have generated recurring net losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have funded our operations primarily through equity financings and from the proceeds received from our former collaboration agreement with Gilead. Through December 31, 2025, we have raised an aggregate of $1.1 billion from such transactions, including $857.0 million in aggregate gross proceeds from the sale of pre-public entity preferred shares, the closing of our Business Combination, follow-on public and private offerings, and through our "at-the-market" stock offering programs, and $237.1 million through our former collaboration with Gilead. Additionally, during the first quarter of 2026, and through March 2, 2026, we have received gross proceeds of $62.1 million from our "at-the-market" stock offering program. As of December 31, 2025, we had cash and cash equivalents and marketable securities of $343.1 million.
Funding Requirements
We expect that our existing cash, cash equivalents and marketable securities on hand as of December 31, 2025 of $343.1 million will enable us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
Cash Flows
Comparison of the Years Ended December 31, 2025 and 2024
The following table summarizes our cash flows for each of the years presented:
|
Year Ended December 31, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(in thousands) |
||||||||||||
|
Net cash used in operating activities |
$ |
(138,886 |
) |
$ |
(131,501 |
) |
$ |
(7,385 |
) |
|||
|
Net cash (used in) provided by investing activities |
(40,865 |
) |
86,126 |
(126,991 |
) |
|||||||
|
Net cash provided by financing activities |
222,500 |
47,664 |
174,836 |
|||||||||
|
Net increase in cash, cash equivalents and restricted cash |
$ |
42,749 |
$ |
2,289 |
$ |
40,460 |
||||||
Operating Activities
Net cash used in operating activities was $138.9 million for the year ended December 31, 2025 compared to net cash used in operating activities of $131.5 million for the year ended December 31, 2024. The increase in net cash used in operating activities for the twelve months ended December 31, 2025 was primarily due to a decrease in operating assets and liabilities, including a deferred revenue decrease driven by the truncation of the Gilead collaboration in August of 2025, which was partially offset by a decrease in net loss.
Investing Activities
Net cash used in investing activities was $40.9 million for the year ended December 31, 2025 compared to net cash provided by investing activities of $86.1 million for the year ended December 31, 2024. The change was primarily due to an increase in purchases of marketable securities and a decrease in sales and maturities of marketable securities as compared to the year ended December 31, 2024.
Financing Activities
Net cash provided by financing activities was $222.5 million for the year ended December 31, 2025 compared to net cash provided by financing activities of $47.7 million for the year ended December 31, 2024. The cash provided by financing activities for the twelve months ended December 31, 2025 consisted of the net proceeds received from our underwritten offering and concurrent private placement of common shares and pre-funded warrants to purchase common shares in October 2025 of $211.8 million, as well as the cash provided from the exercises of stock options and ESPP purchases. The cash provided by financing activities for the twelve months ended December 31, 2024 consisted of the $41.7 million in net proceeds received from our "at-the-market" stock offering program in January 2024, as well as the cash provided from the exercises of stock options and ESPP purchases .
Contractual Obligations and Commitments
The following table summarizes our contractual obligations at December 31, 2025 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:
|
Payments Due by Period |
||||||||||||||||||||
|
Total |
Less than |
1 - 3 Years |
3 - 5 Years |
More than |
||||||||||||||||
|
(in thousands) |
||||||||||||||||||||
|
Operating lease commitments |
$ |
44,367 |
$ |
5,308 |
$ |
12,077 |
$ |
12,813 |
$ |
14,169 |
||||||||||
|
Total |
$ |
44,367 |
$ |
5,308 |
$ |
12,077 |
$ |
12,813 |
$ |
14,169 |
||||||||||
The commitment amounts in the table above primarily reflect the minimum payments due under our amended operating lease for office and laboratory space at our 201 Brookline Avenue, Boston, Massachusetts location. These commitments are also recognized as operating lease liabilities in our balance sheet at December 31, 2025. Refer to Note 7 to our audited consolidated financial statements and related notes included in this Annual Report on Form 10-K for additional discussion of the lease.
Purchase Obligations
In the normal course of business, we enter into contracts with third parties for preclinical studies, clinical operations, manufacturing and research and development supplies. These contracts generally do not contain minimum purchase commitments and generally provide for termination on notice, and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of December 31, 2025.
License Agreement Obligations
We have also entered into a license agreement under which we may be obligated to make milestone and royalty payments. We have not included future milestone or royalty payments under the agreement in the table above since the payment obligations are contingent upon future events, such as achieving certain development, regulatory, and commercial milestones or generating product sales. As of December 31, 2025 and December 31, 2024, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. Refer to Note 8 of our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in this Annual Report on Form 10-K for a description of our license agreement.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues 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 and at the time these estimates are made, 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. We evaluate our estimates and assumptions on an ongoing basis. Some of the judgments and estimates we make can be subjective and complex. Our actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the consolidated financial statements prospectively from the date of change in estimates.
While our significant accounting policies are described in more detail in Note 2 to our audited consolidated financial statements and related notes included in this Annual Report on Form 10-K for the year ended December 31, 2025, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
The terms of our collaboration agreements may include consideration such as non-refundable up-front payments, license fees, research extension fees, and clinical, regulatory and sales-based milestones and royalties on product sales.
We recognize revenue under ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. ASC 606 provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the revenue standard, we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) determine whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be likely. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. We then allocate the transaction price (the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled.
We recognize the transaction price allocated to license payments as revenue upon delivery of the license to the customer and resulting ability of the customer to use and benefit from the license, if the license is determined to be distinct from the other performance obligations identified in the contract. If the license is considered to not be distinct from other performance obligations, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied (i) at a point in time, but only for licenses determined to be distinct from other performance obligations in the contract, or (ii) over time; and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from license payments. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We evaluate whether it is probable that the consideration associated with each milestone payment will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are considered constrained and excluded from the transaction price until they meet this threshold. Milestones tied to regulatory approval, and therefore not within our control, are considered constrained until such approval is received. Upfront and ongoing development milestones under our collaboration agreements are not subject to refund if the development activities are not successful. At the end of each subsequent reporting period, we re-evaluate the probability of a significant reversal of the cumulative revenue recognized for the milestones, and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues from collaborators in the period of adjustment. We exclude sales-based milestone payments and royalties from the transaction price until the sale occurs (or, if later, until the underlying performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied), because the license to our intellectual property is deemed to be the predominant item to which the royalties relate as it is the primary driver of value.
ASC 606 requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in ASC 606 as the price at which an entity would sell a promised good or service separately to a customer. If other observable transactions in which we have sold the same performance obligation separately are not available, we are required to estimate the standalone selling price of each performance obligation. Key assumptions to determine the standalone selling price may include forecasted revenues,
development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
Whenever we determine that multiple promises to a customer are not distinct and comprise a combined performance obligation that includes services, we recognize revenue over time using the cost-to-cost input method, based on the total estimated cost to fulfill the obligation. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement.
Consideration that does not meet the requirements to satisfy the above revenue recognition criteria is a contract liability and is recorded as deferred revenue in the consolidated balance sheets. We have recorded short-term and long-term deferred revenue on our consolidated balance sheets based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue.
In certain instances, the timing of and total costs of satisfying these obligations under our collaboration agreement can be difficult to estimate. Accordingly, our estimates may change in the future. If these estimates and judgments change over the course of these agreements, it may affect the timing and amount of revenue that we will recognize and record in future periods.
Under ASC 606, we will recognize revenue when we fulfill our performance obligations under the agreements with customers. As the required performance obligation is satisfied, we will recognize revenue for the portion satisfied and record a receivable for any fees that have not been received. Amounts are recorded as short-term collaboration receivables when our right to consideration is unconditional. A contract liability is recognized when a customer prepays consideration or owes payment to an entity in advance of our performance according to a contract. We do not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial.
Accrued Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments, which would be recorded as a prepaid expense in other assets, or if there is the right of offset, offset against our liability balance with the counterparty. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary.
We record the expense and accrual related to research and development activities performed by our vendors based on our estimates of the services received and efforts expended considering a number of factors, including our knowledge of the progress towards completion of the research and development activities; invoicing to date under the contracts; communication from the vendors of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Recently Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our audited consolidated financial statements and related notes in this Annual Report on Form 10-K for the year ended December 31, 2025.
Smaller Reporting Company Status
As of June 30, 2025, the last business day of our most recently completed second fiscal quarter, the aggregate market value of the our voting and non-voting common equity held by non-affiliates, based on the closing price of the shares of common stock on The Nasdaq Stock Market LLC on June 30, 2025, was approximately $528.4 million. As the market value of our stock held by non-affiliates was less than $560 million on the measurement date and our annual revenue was less than $100 million during the most recently completed fiscal year, our filer status changed to non-accelerated filer and we again qualify as a "smaller reporting company." 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 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. As a smaller reporting company we may 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.