Context Therapeutics Inc.
For the period ended Mar 31, 2026. Filed May 6, 2026.
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Mar 31, 2026 · Filed May 6, 2026
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Notes to the Unaudited Condensed Consolidated Financial Statements
CONTEXT THERAPEUTICS INC.
Notes to Unaudited Condensed Consolidated Financial Statements
(1)Organization and Description of Business
Context Therapeutics Inc. (the “Company”) is a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies (“bsAb”) for solid tumors. The Company’s product candidates include CTIM-76, a Claudin 6 (“CLDN6”) x CD3 TCE, CT-95, a Mesothelin (“MSLN”) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (“Nectin-4”) x CD3 TCE.
The Company was organized in April 2015 under the laws of the State of Delaware. The Company is headquartered in Philadelphia, Pennsylvania.
(2)Risks and Liquidity
The Company has incurred losses and negative cash flows from operations since inception and had an accumulated deficit of $139.6 million as of March 31, 2026. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its current or any future product candidates. The Company believes its cash and cash equivalents of $54.5 million as of March 31, 2026 are sufficient to fund its projected operations for a period of at least 12 months from the issuance date of these unaudited condensed consolidated financial statements. Substantial additional funding will be needed by the Company to fund its operations and to commercially develop its current and any future product candidates.
Management plans to seek additional capital in the future through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements to carry out the Company’s planned development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations until such funding is received. There is no assurance that such financing will be available when needed or on acceptable terms. Various internal and external factors will affect whether and when the Company’s current or any future product candidates become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s current and any future product candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the approval process will materially affect the Company’s financial condition and future operations.
The Company faces risks associated with companies whose products are in development. These risks include the need for additional financing to complete its research and development, achieving its research and development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key members of management, among others.
(3)Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the unaudited condensed consolidated financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2026, and its results of operations and cash flows for the three months ended March 31, 2026 and 2025. Operating results for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. The unaudited condensed consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2025. The consolidated financial information as of December 31, 2025 included herein has been derived from the annual audited consolidated financial statements.
The unaudited condensed consolidated financial statements include the accounts of the Company, Context Therapeutics LLC, Context Biopharma, Inc. and Context Ireland Ltd., the Company’s wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Estimates and assumptions are periodically reviewed, and the effects of the revisions are reflected in the accompanying unaudited condensed consolidated financial statements in the period they are determined to be necessary. Significant estimates and assumptions made in the accompanying unaudited condensed consolidated financial statements include, but are not limited to, share-based compensation arrangements, the fair value of warrants, and in recording the prepayments, accruals and associated expense for research and development activities performed for the Company by third parties.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company hasone reportable segment which consists of the development of clinical and preclinical product candidates for the advancement of therapies to treat solid tumors. The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
The accounting policies of the Company’s segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the Company’s segment based on net loss, which is reported on the condensed consolidated statements of operations as net loss. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seeks regulatory approval. As such, the CODM uses cash forecast models in deciding how to deploy capital at the Company. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment, along with cash forecast models. The CODM is regularly provided with net loss and consolidated assets, which are reported on the unaudited condensed consolidated statements of operations and unaudited condensed consolidated balance sheets, respectively.
The table below summarizes the significant expense and income categories regularly reviewed by the CODM for the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Operating Expenses: | ||
| CTIM-76 | $2,284,033 | $1,060,759 |
| CT-95 | 1,389,773 | 765,030 |
| CT-202 | 1,904,761 | 983,573 |
| Personnel-related costs | 2,203,587 | 1,356,134 |
| Professional fees | 689,431 | 643,222 |
| Share-based compensation | 409,220 | 293,717 |
| Other segment items (a) | 462,994 | 426,708 |
| Loss from operations | (9,343,799) | (5,529,143) |
| Interest income | 520,139 | 958,517 |
| Other income (expense) | 143,088 | (6,635) |
| Segment and Net Loss | $(8,680,572) | $(4,577,261) |
(a)Other segment items included in Segment loss mainly includes board fees, insurance, facilities and information technology costs.
The Company tracks outsourced development costs and other external research and development costs to specific product candidates on a program-by-program basis. However, it does not track internal research and development expenses on a program-by-program basis as they primarily relate to compensation, early research and other costs which are deployed across multiple projects under development.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values given their short-term nature.
Cash and Cash Equivalents
The Company considers all highly-liquid investments that have original maturities of three months or less when acquired to be cash equivalents. Cash equivalents consist of amounts invested in money market accounts. At March 31, 2026, the Company’s cash and cash equivalent balances exceeded federally insured limits by approximately $54.0 million.
Deferred Offering Costs
The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, the costs are recorded as a reduction of additional paid-in capital generated as a result of such offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the condensed consolidated statements of operations. As of March 31, 2026 and December 31, 2025, there was $0.2 million of deferred offering costs included in prepaid expenses and other current assets.
Property and Equipment
Property and equipment consist of office equipment, furniture, and leasehold improvements and are recorded at cost. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. Leasehold improvements are amortized over the shorter of their economic lives or the remaining lease term.
Leases
The Company determines if an arrangement is a lease at inception. Balances recognized related to operating leases are included in operating lease right-of-use assets and operating lease liabilities in the condensed consolidated balance sheets. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid.
Acquired In-Process Research and Development Costs
Acquired in-process research and development (“IPR&D”) expense consists of payments incurred in connection with the acquisition or licensing of products or technologies that do not meet the definition of a business under FASB ASC Topic 805, Business Combinations. Payments for acquired IPR&D as well as future product development milestones are initially treated as the acquisition of an asset but then immediately expensed as there is no future alternative use for the asset. These payments are reflected as a component of research and development expense as well as an investing activity outflow on the Company’s condensed consolidated statements of cash flows due to the nature of the underlying acquisition of an asset. See Note 8 for further discussion.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, acquired IPR&D, salaries, share-based compensation, and other operational costs related to the Company’s research and development activities.
Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the unaudited condensed consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Patent Costs
Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain.
Share-Based Compensation
The Company measures and recognizes share-based compensation expense for both employee and non-employee awards based on the grant date fair value of the awards. The Company recognizes share-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company recognizes forfeitures as they occur.
The Company classifies share-based compensation expense in its condensed consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.
The Company estimates the fair value of employee and non-employee stock awards as of the date of grant using the Black-Scholes option pricing model. The Company lacks Company-specific historical and implied volatility information. Therefore, management estimates the expected share price volatility based on the historical volatility of a publicly traded set of peer companies in addition to the Company's historical volatility information. Management expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own publicly traded share price. The expected term of the Company’s stock awards has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” stock awards. The risk-free interest rate is determined by reference to the yield curve of a zero-coupon U.S. Treasury bond on the date of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future.
Net Loss Per Share
Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period, including outstanding pre-funded warrants to purchase shares of common stock that were issued in the private placement transaction in May 2024 (Note 6). Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as preferred stock, warrants (excluding pre-funded warrants) and share-based awards, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
| March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Stock options | 8,099,074 | 5,458,875 |
| Warrants | 5,860,000 | 5,860,000 |
| 13,959,074 | 11,318,875 | |
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these unaudited condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company’s adoption of this pronouncement did not have a material effect on the Company’s disclosures.
Recently Issued but Not yet Adopted Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses. ASU 2024-03 requires additional disclosure of specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The requirements will be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its disclosures.
(4)Fair Value Measurements
The Company utilizes a valuation hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques related to its financial assets and financial liabilities. The three levels of inputs used to measure fair value are described as follows:
Level 1 – Observable inputs such as quoted prices in active markets.
Level 2 – Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly.
Level 3 – Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.
In accordance with the fair value hierarchy described above, the following table sets forth the Company’s assets and liabilities measured at fair value on a recurring basis:
| Total | Quoted Prices in ActiveMarkets for IdenticalAssets (Level 1) | Significant OtherObservable Inputs(Level 2) | SignificantUnobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Financial assets | ||||
| Cash equivalents (Money Market Accounts) | $54,041,446 | $54,041,446 | $— | $— |
| Total | Quoted Prices in ActiveMarkets for IdenticalAssets (Level 1) | Significant OtherObservable Inputs(Level 2) | SignificantUnobservable Inputs(Level 3) | |
|---|---|---|---|---|
| Financial assets | ||||
| Cash equivalents (Money Market Accounts) | $65,523,204 | $65,523,204 | $— | $— |
(5)Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| March 31, 2026 | December 31, 2025 | |
|---|---|---|
| Compensation and benefits | $438,276 | $1,384,430 |
| Research and development costs | 2,487,578 | 3,913,168 |
| Professional fees | 61,590 | 38,524 |
| Accrued contingency | 850,000 | — |
| Other | 71,121 | 38,968 |
| Total | $3,908,565 | $5,375,090 |
(6)Stockholders' Equity
Increase to Authorized Shares
On September 17, 2024, the Company held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders approved, among other things, an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 100,000,000 to 200,000,000.
Private Placement
On May 1, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for the private placement (the “Private Placement”) of (i)59,032,259 shares (the “PIPE Shares”) of the Company’s common stock at a purchase price of $1.55 per PIPE Share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,482,741 shares of common stock at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. During year ended December 31, 2025,2,178,200 Pre-Funded Warrants were exercised on a cashless basis, resulting in the issuance of 2,174,983 shares of common stock. As of March 31, 2026,3,304,541 Pre-Funded Warrants remained outstanding.
At-the-Market Facility
On December 2, 2024, the Company entered into a Sales Agreement (the “ATM Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the ATM Sales Agreement, the Company may offer and sell shares of the Company’s common stock (the “ATM Shares”), having an aggregate offering amount of up to $75.0 million from time to time through the Agent. Sales of the ATM Shares may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. On October 24, 2025, the Company entered into Amendment No. 1 to Sales Agreement (the “Amendment”, and together with the ATM Sales Agreement, the “Amended ATM Sales Agreement”) to provide for an increase in the aggregate offering amount under the Amended ATM Sales Agreement, such that following the filing of a new prospectus supplement with respect to the ATM Shares on October 24, 2025, the Company may offer and sell ATM Shares having an aggregate offering price of up to $75.0 million, exclusive of ATM Shares previously sold in December 2024.
Warrants for Common Stock
At March 31, 2026, the Company had the following warrants outstanding to acquire common stock:
| Outstanding | Exercise price | Expiration dates | |
|---|---|---|---|
| Issued in connection with 2021 initial public offering | 250,000 | $6.25 | October 2026 |
| Issued in connection with 2021 private placement | 5,250,000 | $6.25 | June 2027 |
| Issued in 2022 for consulting services | 360,000 | $10.00 | December 2027 |
| Issued in connection with 2024 private placement | 3,304,541 | $0.001 | No expiration |
(7)Share-Based Compensation
In April 2021, the Company adopted the 2021 Long-Term Performance Incentive Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company can grant stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”) and stock grants. On its initial effective date, the 2021 Incentive Plan allowed for the issuance of up to 1,266,092 shares of common stock (the “Share Limit”). The Share Limit automatically increases on January 1st of each year, during the term of the 2021 Incentive Plan, commencing on January 1 of the year following the year in which the effective date occurs, in an amount equal to four percent (4%) of the total number of shares of the Company’s common stock outstanding on December 31st of the preceding calendar year; provided that the board of directors may determine that there will be no such increase or a smaller increase for any particular year. As of March 31, 2026,2,817,769 shares remained available for future grants.
In addition, from time to time, the Company makes inducement grants of stock options to new hires, which awards are made pursuant to the Nasdaq’s inducement grant exception to the shareholder approval requirement for grants of equity compensation. During the three months ended March 31, 2026 and 2025, the Company granted inducement stock options covering 120,000 and 46,000 shares, respectively, of the Company’s common stock to new employees.
Share-based awards generally vest over a period ofone year tofour years, and share-based awards that lapse or are forfeited are available to be granted again. The contractual life of all share-based awards isten years. The expiration dates of the outstanding share-based awards range from January 2028 to March 2036.
The Company measures share-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the service period of the awards. Share-based compensation is allocated to employees and consultants based on their respective departments. All board of directors’ compensation is charged to general and administrative expense.
Share-based compensation expense related to the issuance of stock options was as follows for the three months ended March 31, 2026 and 2025:
| Three Months Ended March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Research and development | $55,084 | $47,070 |
| General and administrative | 354,136 | 246,647 |
| $409,220 | $293,717 | |
The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of share-based awards granted during the three months ended March 31, 2026 and 2025 were as follows:
| 2026 | 2025 | |
|---|---|---|
| Expected stock price volatility | 105.47% | 111.56% |
| Risk-free interest rate | 3.75% | 4.42% |
| Expected term (in years) | 6.08 | 6.07 |
| Expected dividend yield | — | — |
The following table summarizes the share-based award activity for the periods presented:
| Number of Shares | Weighted AverageExercise Price PerShare | Weighted AverageRemainingContractual Term(years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding at January 1, 2026 | 5,868,500 | $1.33 | 8.2 | $2,941,679 |
| Granted | 2,330,500 | $2.28 | ||
| Forfeited | (99,926) | $1.25 | ||
| Outstanding at March 31, 2026 | 8,099,074 | $1.60 | 8.5 | $9,468,855 |
| Vested and exercisable at March 31, 2026 | 2,763,426 | $1.90 | 6.9 | $3,218,919 |
| Vested and expected to vest at March 31, 2026 | 8,099,074 | $1.60 | 8.5 | $9,468,855 |
The aggregate intrinsic value in the above table is calculated as the difference between the fair market value of the Company’s common stock price and the exercise price of the stock options. The weighted average fair value of share-based awards granted during the three months ended March 31, 2026 and 2025 was $1.89 and $0.69, respectively. As of March 31, 2026, the unrecognized compensation cost related to outstanding share-based awards was $5.9 million and is expected to be recognized as expense over a weighted-average period of approximately 3.5 years.
(8)Commitments and Contingencies, including License Agreements
Operating Lease
In July 2024, the Company amended its lease, that it initially entered into in March 2023 for corporate office space in Philadelphia, Pennsylvania, to extend the expiration date to November 30, 2026. In January 2026, the Company further amended the lease in order to renew the lease forone additional successiveone-year period and obtain additional office space. The Company also retains the right to renew the lease for an additional 12-month term upon at least nine months advance notice to the landlord, including the right to remove the additional office space from that renewal.
This renewal option was not contemplated in the Company's calculation of its right-of-use asset and lease liability.
As of March 31, 2026, the operating lease right-of-use asset and the operating lease liabilities were each $0.3 million, which were estimated using a discount rate of 11%. As of March 31, 2026, the remaining term of the Company’s noncancellable operating lease was 1.67 years. Future minimum lease payments under the sublease are $0.3 million at March 31, 2026.
The Company recognizes rent expense on a straight-line basis over the lease period and accrues for rent expense incurred but not yet paid. Rent expense related to the Company’s operating lease was approximately $37,000 and $32,000 for the three months ended March 31, 2026 and 2025, respectively.
Employee Benefit Plans
The Company established a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company contributes a safe harbor minimum contribution equivalent to 3% of employees’ compensation. For the three months ended March 31, 2026 and 2025, the Company provided contributions of approximately $66,000 and $49,000, respectively.
Collaboration and Licensing Agreement with Integral Molecular
In April 2021, the Company entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 bsAb for cancer therapy. Under the terms of the Integral License Agreement, Integral and the Company developed a CLDN6 bsAb that is intended to trigger the activation of T cells and eliminate cancer cells displaying CLDN6. The Company will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. The payment for the initial upfront license fee as well as subsequent payments for milestones achieved were expensed to acquired IPR&D. As a part of the Integral License Agreement, Integral was eligible to receive remaining development and regulatory milestone payments totaling approximately $55.0 million, sales milestone payments totaling up to $130.0 million, and tiered royalties of up to 12% of net sales of certain products developed under the Integral License Agreement.
On March 20, 2023, the Company amended the Integral License Agreement (the “First Amendment”) to remove the previously agreed to second milestone payment and to change the amount of the third milestone payment to increase such payment by the amount of the prior second milestone payment and to add payment for third-party research funding obtained and used by Integral in connection with the development of CTIM-76.
On February 29, 2024, the Company further amended the Integral License Agreement (the “Second Amendment”) to reflect updated financial terms. Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrowed the license grant from Integral to the Company to only cover CTIM-76, removed any further obligation to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.
Asset Purchase Agreement
On July 9, 2024, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) pursuant to which the Company acquired CT-95 (formerly known as LNK-101), an MSLN x CD3 TCE bsAb, from Link (assignment for the benefit of creditors), LLC (“Link”), which succeeded to the assets of Link Immunotherapeutics Inc.
Pursuant to the Asset Purchase Agreement, the Company purchased all of the assets from Link associated with CT-95, including patent rights, know-how, regulatory filings, and inventory of drug substance and drug product (the “Transferred Assets”), on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Taiwan and Japan. The Company also assumed certain liabilities relating to the Transferred Assets. In consideration of the purchase of the Transferred Assets, the Company made a one-time payment to Link of $3.75 million and is not obligated to make any other payments. This transaction qualified as an asset purchase as prescribed by ASC 805-50 and the assets purchased were determined to have no alternative future use under the accounting definition, and therefore, the Company expensed the one-time payment as a component of research and development expense in the consolidated statements of operations during the year ended December 31, 2024.
Collaboration and Licensing Agreement with BioAtla
On September 23, 2024, the Company entered into a license agreement (the “BioAtla License Agreement”) with BioAtla, Inc. ("BioAtla"), pursuant to which the Company obtained an exclusive, worldwide license to develop, manufacture and commercializetwo licensed antibodies (the “BioAtla Assets”), including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 T cell engaging bispecific antibody.
As partial consideration for the exclusive license under the BioAtla License Agreement, the Company made an upfront payment of $11.0 million for the IPR&D asset, which was determined to have no alternative future use under the accounting definition. Therefore, the upfront payment was expensed as a component of research and development expense in the consolidated statements of operations during the year ended December 31, 2024. The Company may be obligated to pay up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions. In October 2025, the Company achieved a $2.0 million development milestone under the BioAtla License Agreement, which was expensed as a component of research and development expense in the consolidated statements of operations for the year ended December 31, 2025. The BioAtla License Agreement will continue on a country-by-country, product-by-product basis until the expiration of the royalty term as defined in the BioAtla License Agreement, unless earlier terminated.
CTIM-76 and CT-202 Lonza License Agreements
The Company has obtained active pharmaceutical ingredients and drug product for its product candidates from several third-party contract manufacturers, including Lonza Sales AG (“Lonza Sales”) and Lonza AG (“Lonza AG”, and collectively with Lonza Sales, “Lonza”).
On November 7, 2022, the Company entered into a license agreement (the “Lonza CTIM-76 License Agreement”) with Lonza Sales in connection with Lonza’s development and manufacturing services with respect to CTIM-76. Under the terms of the Lonza CTIM-76 License Agreement, to the extent Lonza’s technology is incorporated into CTIM-76, Lonza granted the Company a non-exclusive license to use certain proprietary Lonza intellectual property and systems for the Company to develop, manufacture and commercially exploit CTIM-76.
On November 3, 2025, the Company entered into a license agreement (the “Lonza CT-202 License Agreement”) with Lonza Sales in connection with Lonza’s development and manufacturing services with respect to CT-202. Under the terms of the Lonza CT-202 License Agreement, to the extent Lonza’s technology is incorporated into CT-202, Lonza granted the Company a non-exclusive license to use certain proprietary Lonza intellectual property and systems for the Company to develop, manufacture and commercially exploit CT-202.
The Company shall pay certain royalties and annual payments to Lonza under the applicable license agreement with respect to the manufacturing and sale of CTIM-76 or CT-202, as applicable, which amounts shall be determined by the party manufacturing CTIM-76 or CT-202, as applicable, and ranges from a potential annual payment of up to less than $500,000 per asset and a royalty per asset on net sales from 0% up to a low single digit percentage. Under each respective license agreement, the royalty payments and annual payments would be reduced per asset in certain circumstances, including should the valid claims for any such patent rights not exist in the country in which CTIM-76 or CT-202, as applicable, is being sold, and the royalty payments per asset would expire upon the later of the expiration of the licensed patents in the country in which CTIM-76 or CT-202, as applicable, is being sold, the expiration of the licensed patents in the country in which CTIM-76 or CT-202, as applicable, is being manufactured, and 10 years from the first commercial sales of CTIM-76 or CT-202, as applicable, in such country of sale.
The Lonza CTIM-76 License Agreement and the Lonza CT-202 License Agreement each continue until terminated. The Company or Lonza may terminate either the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement, as applicable, for uncured material breaches or insolvency of the other party. The Company can unilaterally terminate the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement with prior written notice to Lonza, and Lonza can also unilaterally terminate the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement upon certain actions by the Company.
Research and Development Arrangements
In the course of normal business operations, the Company enters into agreements with investigative sites and contract research organizations to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls-related expenses. Expenditures to contract research organizations represent a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash.
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated.
On February 4, 2026, the Vladimir Gusinsky Revocable Trust filed a stockholder class action complaint (the “Action”) against the Company and its directors in the Court of Chancery of the State of Delaware (the “Court”) asserting that (i) Article V, Section 2 of the Company's Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), provides for a full term of three years for directors in violation of Section 211(b) of the General Corporation Law of the State of Delaware (the “DGCL”) and (ii) Article VI, Section 1 of the Certificate of Incorporation limits removal of directors only for cause in violation of Section 141(k) of the DGCL.
On February 24, 2026, a stipulation and proposed consent judgment (the “Stipulated Judgment”) was filed with the Court regarding the Action, and on March 11, 2026, the Court approved the Stipulated Judgment, pursuant to which Article V, Section 2 and Article VI, Section 1 of the Certificate of Incorporation were determined to be invalid and unenforceable. On March 11, 2026, the Company filed a Certificate of Correction with the Delaware Secretary of State reflecting such provisions as invalid, unenforceable and no longer part of the Certificate of Incorporation. On March 11, 2026, pursuant to the Stipulated Judgment, the Action was dismissed with prejudice with respect to the plaintiff; however, the Court retained jurisdiction to address any mootness fee application.
On April 30, 2026, the Company entered into a letter agreement (the “Letter Agreement”), pursuant to which a third party service provider (the “Provider”) of the Company agreed to pay the Mootness Fee (as defined below) in full on behalf of the Company.
On April 30, 2026, the Court granted a Stipulation and Proposed Order Closing the Case (the “Stipulated Order”). The Stipulated Order requires the payment of $0.9 million in fees and expenses to plaintiff’s counsel in the Action (the “Mootness Fee”). The Court was not asked to review, and did not pass judgment on, entitlement to or the amount of the Mootness Fee being paid in connection with the Stipulated Order.
On May 1, 2026, the Provider paid the Mootness Fee in full pursuant to the Letter Agreement. The Action will be closed after the Court is informed a quorum was achieved at the Company’s 2026 annual meeting of stockholders, which is scheduled to be held on June 24, 2026.
The Company has accrued a liability of $0.9 million as of March 31, 2026 based on management's assessment that a loss is probable and reasonably estimable. However, based on the expected recovery of the full amount from the Provider, the Company has recognized a receivable of $0.9 million as of March 31, 2026 which is included in Other Current Assets.
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