Skip to main content

CURIS INC

For the period ended Dec 31, 2024. Filed Mar 31, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 31, 2025

CRIS$0.65-6.4%Stored close · as of Nov 10, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Stockholders of Curis, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Curis, Inc. and its subsidiaries (the "Company") as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring losses and cash outflows from operations that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

External Research and Development Costs

As described in Note 2 to the consolidated financial statements, research and development costs are expensed as incurred. These expenses primarily include salaries and related expense for personnel, including stock-based compensation expense, external research and development costs, regulatory costs, facility costs, and certain payments made under collaboration agreements. The Company’s research and development expense for the year ended December 31, 2024 was $38.6 million, a significant portion of which relates to external research and development costs. Management recognizes external research and development costs based on an evaluation of the level of activity and services performed using information provided to the Company by its service providers. This process involves reviewing vendor invoices, open contracts and purchase orders, communicating with applicable personnel to identify services that have been performed on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs.

The principal consideration for our determination that performing procedures relating to external research and development costs is a critical audit matter is a high degree of auditor effort in performing procedures related to the Company’s external research and development costs.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others, testing external research and development costs, on a sample basis, by obtaining and inspecting source documentation such as the underlying contractual agreements, purchase orders, invoices received, and information received from third-party service providers, where applicable.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts

March 31, 2025

We have served as the Company's auditor since 2002.

Consolidated Balance Sheets

(In thousands, except share and per share data)

December 31,
20242023
ASSETS
Current assets:
Cash and cash equivalents$19,997$26,681
Short-term investments—29,653
Accounts receivable3,3492,794
Prepaid expenses and other current assets3,0391,780
Total current assets26,38560,908
Property and equipment, net231434
Restricted cash, long-term544544
Operating lease right-of-use asset3,1633,056
Other assets1,9603,358
Goodwill8,9828,982
Total assets$41,265$77,282
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable$3,024$3,172
Accrued liabilities7,1119,040
Current portion of operating lease liability1,3361,305
Current portion of liability related to sale of future royalties7,5568,504
Total current liabilities19,02722,021
Long-term operating lease liability1,6181,489
Liability related to the sale of future royalties, net26,61834,102
Total liabilities47,26357,612
Stockholders’ equity:
Preferred stock, $0.01 par value—5,000,000 shares authorized, no shares issued and outstanding at December 31, 2024 and 2023——
Common stock, $0.01 par value—34,171,875 shares authorized, 8,487,818 shares issued and outstanding at December 31, 2024; 22,781,250 shares authorized, 5,894,085 shares issued and outstanding at December 31, 20238559
Additional paid-in capital1,233,7161,215,792
Accumulated deficit(1,239,799)(1,196,410)
Accumulated other comprehensive gain (loss)—229
Total stockholders’ equity (deficit)(5,998)19,670
Total liabilities and stockholders’ equity (deficit)$41,265$77,282

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

Years Ended December 31,
20242023
Revenues, net$10,908$10,023
Operating expenses:
Cost of royalties98212
Research and development38,56239,496
General and administrative16,79018,647
Total operating expenses55,45058,355
Loss from operations(44,542)(48,332)
Other income:
Interest income1,7682,938
Expense related to the sale of future royalties(615)(2,019)
Total other income1,153919
Net loss$(43,389)$(47,413)
Net loss per common share (basic and diluted)$(6.88)$(8.96)
Weighted average common shares (basic and diluted)6,306,2845,293,294
Net Loss$(43,389)$(47,413)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities(229)415
Comprehensive loss$(43,618)$(46,998)

Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share data)

Common Stock · AdditionalPaid-inCapital · AccumulatedDeficit · AccumulatedOtherComprehensiveGain (Loss) · TotalStockholders’Equity (Deficit)
Shares · Amount
December 31, 20224,830,464$48$1,195,687$(1,148,997)$(186)$46,552
Issuance of common stock in connection with 2023 Registered Direct, net of issuance costs920,488913,805——13,814
Stock-based compensation——6,000——6,000
Issuance of common stock under employee benefit plans, including restricted stock awards149,6332300——302
Cancellation of restricted stock awards(6,500)—————
Unrealized gain on marketable securities————415415
Net loss———(47,413)—(47,413)
December 31, 20235,894,085$59$1,215,792$(1,196,410)$229$19,670
Stock-based compensation——5,927——5,927
Issuance of common stock in connection with October 2024 Financings, net of issuance costs2,398,414245,948——5,972
Issuance of warrants in connection with October 2024 Financings, net of issuance costs——4,798——4,798
Issuance of shares in connection with 2024 Sales Agreement, net of issuance costs188,31621,110——1,112
Issuance of common stock under employee benefit plans, net of shares received to settle minimum tax obligation for vesting of restricted stock awards11,378—141——141
Cancellation of restricted stock awards(4,375)—————
Reclassification of accumulated gain on maturity of investments————(229)(229)
Net loss———(43,389)—(43,389)
December 31, 20248,487,818851,233,716(1,239,799)—(5,998)

Consolidated Statements of Cash Flows

(In thousands)

Years Ended December 31,
20242023
Cash flows from operating activities:
Net loss$(43,389)$(47,413)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization203255
Non-cash lease expense1,2741,344
Stock-based compensation expense5,9276,000
Non-cash activity related to the sale of future royalties154(340)
Amortization of premiums and discounts on investments(16)(1,059)
Changes in operating assets and liabilities:
Accounts receivable(555)181
Prepaid expenses and other assets139405
Accounts payable and accrued and other liabilities(2,077)3,340
Operating lease liability(1,223)(1,147)
Total adjustments3,8268,979
Net cash used in operating activities(39,563)(38,434)
Cash flows from investing activities:
Purchases of investments(18,098)(70,340)
Sales and maturities of investments47,540108,126
Net cash provided by investing activities29,44237,786
Cash flows from financing activities:
Proceeds from issuance of common stock and Warrants, net of issuance costs12,02314,117
Payment of liability of future royalties, net of imputed interest(8,586)(6,537)
Net cash provided by financing activities3,4377,580
Net increase (decrease) in cash and cash equivalents and restricted cash(6,684)6,932
Cash and cash equivalents and restricted cash, beginning of period27,22520,293
Cash and cash equivalents and restricted cash, end of period$20,541$27,225
Supplemental cash flow data:
Issuance costs in accounts payable50—
Cash paid for interest4612,359
Increase in right-of-use assets and operating lease liabilities resulting from lease modification(1,383)—
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents19,99726,681
Restricted cash, long-term544544
Total cash, cash equivalents and restricted cash shown in the statement of cash flows$20,541$27,225

Notes to Consolidated Financial Statements

(1)Nature of Business

Curis, Inc. is a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule inhibitor of Interleukin-1 receptor associated kinase, or IRAK4. Throughout these Consolidated Financial Statements, Curis, Inc. and its wholly owned subsidiaries are collectively referred to as the “Company” or “Curis”.

The Company is party to a collaboration agreement with Genentech Inc. (“Genentech”), a member of the Roche Group, under which Genentech and F. Hoffmann-La Roche Ltd (“Roche”) are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist. Erivedge is approved for the treatment of advanced basal cell carcinoma (“BCC”).

The Company is party to an exclusive collaboration agreement with Aurigene Discovery Technologies Limited (“Aurigene”) for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology, including emavusertib.

The Company is subject to risks common to companies in the biotechnology industry as well as risks that are specific to the Company’s business, including, but not limited to: the Company’s ability to obtain adequate financing to fund its operations; the Company’s ability to continue as a going concern; the Company’s ability to advance and expand its research and development program for emavusertib; the Company’s ability to execute on its overall business strategies; the Company’s ability to obtain and maintain necessary intellectual property protection; development by the Company’s competitors of new or better technological innovations; the Company’s ability to comply with regulatory requirements; the Company’s ability to obtain and maintain applicable regulatory approvals and commercialize any approved drug candidates; and the ability of the Company and its wholly owned subsidiary, Curis Royalty, LLC (“Curis Royalty”), to satisfy the terms of the royalty interest purchase agreement (the “Oberland Purchase Agreement”) with TPC Investments I LP and TPC Investments II LP (the “Purchasers”), each of which is a Delaware limited partnership managed by Oberland Capital Management, LLC, and Lind SA LLC (the “Agent”), a Delaware limited liability company managed by Oberland Capital Management, LLC, as collateral agent for the Purchasers.

The Company’s future operating results will largely depend on the progress of emavusertib and the magnitude of payments that it may receive and make under its current and potential future collaborations. The results of the Company’s operations have varied and will likely continue to vary significantly from year to year and quarter to quarter and depend on a number of factors, including, but not limited to the timing, outcome and cost of the Company’s preclinical studies and clinical trials for its drug candidate.

The Company will require substantial funds in the immediate term to maintain its research and development program and support operations. The Company has incurred losses and cash outflows from operations since its inception. The Company had an accumulated deficit of approximately $1.2 billion as of December 31, 2024 and incurred a net loss of $43.4 million and used $39.6 million of cash in operations for the year ended December 31, 2024. The Company expects to continue to generate operating losses in the foreseeable future.

In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has concluded there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the Consolidated Financial Statements are issued. Based on the Company's $20.0 million of existing cash and cash equivalents at December 31, 2024, recurring losses and cash outflows from operations since inception, an expectation of continuing losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance the Company's future operations, the Company concluded it does not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Annual Report on Form 10-K. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

The Company plans to seek additional funding through a number of potential avenues, including private or public equity financings, collaborations, or other strategic transactions. The Company has faced and expects to continue to face substantial difficulty in raising capital. The Company may not be able to obtain funding on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. The Company’s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of its control, and it may be unable to raise financing when needed, or on terms favorable to the Company. If necessary funds are not available, the Company will have to delay, reduce the scope of, or eliminate its development of emavusertib, potentially delaying the time to market for or preventing the marketing of emavusertib, which would have a material adverse effect on the Company’s operations and future prospects. If the Company is unable to obtain sufficient capital, the Company would be unable to fund its operations and may be required to evaluate alternatives, which could include dissolving and liquidating its assets or seeking protection under the bankruptcy laws, and a determination to file for bankruptcy could occur at a time that is earlier than when the Company would otherwise exhaust its cash resources. If the Company decides to dissolve and liquidate its assets or to seek protection under the bankruptcy laws, it is unclear to what extent the Company would be able to pay its obligations, and, accordingly, it is further unclear whether and to what extent any resources would be available for distributions to stockholders.

(2)Summary of Significant Accounting Policies

(a)Basis of Presentation and Principles of Consolidation

The accompanying Consolidated Financial Statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“GAAP”) and include the accounts of our wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

The Company’s Consolidated Financial Statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. In accordance with FASB ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has concluded there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the Consolidated Financial Statements are issued. The Consolidated Financial Statements do not include any adjustments that might result from the outcome of this uncertainty.

(b)Use of Estimates and Assumptions

The preparation of the Company’s Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of revenue, expenses and certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company’s collaboration agreements; the collectability of receivables; and the value of certain liabilities. Actual results may differ from such estimates.

(c)Cash Equivalents, Restricted Cash, and Investments

Cash equivalents consist of highly liquid investments purchased with original maturities of three months or less.

The Company classified $0.5 million of its cash as restricted cash, long-term as of both December 31, 2024 and 2023. These amounts represent the security deposit associated with the Company's Lexington, Massachusetts headquarters.

The Company’s short-term investments were marketable debt securities with original maturities of greater than three months from the date of purchase, but less than twelve months from the balance sheet date. Marketable securities consisted of commercial paper, corporate bonds and notes, and/or government obligations. All of the Company’s investments were designated available-for-sale and are stated at fair value. Unrealized gains and losses on investments are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Realized gains and losses, dividends and interest income are included in other income in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income. As of December 31, 2024, all of the Company's investments have matured.

(d)Concentrations and Significant Customer Information

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.

The Company's operations are located entirely within the U.S. The Company's focus is primarily on the development of emavusertib, a small molecule IRK4 inhibitor. The Company's customer, Genentech, accounted for 100% and 99% of the total gross revenues for the years ended December 31, 2024 and 2023, respectively.

The Company’s accounts receivable at December 31, 2024 and December 31, 2023 represents amounts due from royalties earned on sales of Erivedge by Genentech and Roche.

The Company relies on third parties to manufacture and supply emavusertib. In addition, there are a small number of suppliers for certain raw materials that the Company uses to manufacture emavusertib.

(e)Long-Lived Assets Other than Goodwill

Long-lived assets other than goodwill consist of property and equipment. The Company applies the guidance in FASB Codification Topic 360-10-05, Impairment or Disposal of Long-Lived Assets. If it were determined that the carrying value of the Company’s other long-lived assets might not be recoverable based upon the existence of one or more indicators of impairment, the Company would measure for impairment. Recoverability is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. The Company did not recognize any material impairment charges for the years ended December 31, 2024 or December 31, 2023.

Purchased equipment is recorded at cost. The Company does not currently hold any leased equipment. Depreciation and amortization are provided on the straight-line method over the estimated useful lives of the related assets or the remaining terms of the leases, whichever is shorter, as follows:

Useful Life
Laboratory equipment, computers and software3-5 years
Leasehold improvementsLesser of lease or asset life
Office furniture and equipment5 years

(f)Leases

The Company determines if an arrangement is a lease at contract inception. The Company made an accounting policy election to not recognize leases with an initial term of 12 months or less within its Consolidated Balance Sheets and to recognize those lease payments on a straight-line basis in its Consolidated Statements of Operations and Comprehensive Loss over the lease term. Operating lease assets represent the Company's right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.

As the Company's lease does not provide an implicit interest rate, the Company uses its incremental borrowing rate, which is based on rates that would be incurred to borrow on a collateralized basis over a term equal to the lease payments in a similar economic environment, in determining the present value of lease payments.

The lease payment used to determine the operating lease asset may include lease incentives, stated rent increases and was recognized as an operating lease right-of-use asset in the Consolidated Balance Sheets. The Company's lease agreements may include both lease and non-lease components, which may be accounted for as a single lease component when the payments are fixed. Variable payments included in the lease agreement are expensed as incurred.

The Company's operating lease is reflected in operating lease right-of-use asset and operating lease liability in the Consolidated Balance Sheets. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

(g)Other assets

Other assets consist of long-term prepayments and deposits.

(h)Goodwill

The Company had goodwill of $9.0 million as of both December 31, 2024 and 2023. The Company applies the guidance in the FASB Codification Topic 350, Intangibles—Goodwill and Other. The Company performs its annual goodwill assessment as of December 31. As part of its annual goodwill assessment, the Company determined (1) it operates as a single reporting unit and (2) the fair value of the Company exceeded the carrying value of its net assets. Accordingly, no goodwill impairment was recognized for each of the years ended December 31, 2024 and 2023, and there have been no cumulative impairments.

(i)Revenue Recognition

The Company applies the revenue recognition guidance in accordance with FASB Codification Topic 606, Revenue from Contracts with Customers.

The Company recognizes royalty revenues related to Genentech’s and Roche’s sales of Erivedge. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company expects to continue recognizing royalty revenue from Genentech’s sales of Erivedge in the U.S. and Roche's sales of Erivedge outside of the U.S. (see Note 10, Research and Development Collaborations). However, a significant portion of Erivedge royalties will be paid to the Purchasers pursuant to the Oberland Purchase Agreement (see Note 8, Liability Related to the Sale of Future Royalties).

(j)Research and Development

The Company expenses research and development costs as they are incurred. Research and development expense primarily consists of costs incurred to discover, research and develop emavusertib. These expenses primarily include: (1) salaries and related expenses for personnel, including stock-based compensation expense; (2) external research and development costs, including amounts paid to clinical centers, clinical research organizations and consultants, costs of contract manufacturing, and the cost of companion drugs; (3) regulatory costs; (4) facility costs; and (5) certain payments that we make under the Company's collaboration agreements. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

(k)External Research and Development Costs

The Company has entered into various research and development contracts with clinical research organizations, clinical manufacturing organizations, and other service providers both inside and outside of the United States. These agreements are generally cancellable. The Company recognizes external research and development costs based on an evaluation of the level of activity and services performed, using information provided to the Company by its service providers. This process involves reviewing vendor invoices, open contracts and purchase orders, communicating with applicable personnel to identify services that have been performed on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs.

(l)Basic and Diluted Loss per Common Share

Basic and diluted net losses per share were determined by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share for all periods presented, as the effect of the potential common stock equivalents is antidilutive due to the Company’s net loss position for all periods presented. Antidilutive securities consist of stock options outstanding of 1,160,251 and 840,880 as of December 31, 2024 and 2023, respectively, unvested restricted stock awards of 40,137 and 110,500 as of December 31, 2024 and 2023, respectively and warrants of 2,398,414 as of December 31, 2024.

(m)Stock-Based Compensation

The Company accounts for stock-based compensation transactions using a grant-date fair-value based method under FASB Codification Topic 718, Compensation-Stock Compensation.

The Company measures compensation cost for stock-based compensation at fair value and recognizes the expense as compensation expense over the period that the recipient is required to provide service in exchange for the award, which generally is the vesting period. The fair value for restricted stock awards is based on the closing share price of the Company's common stock on the date of grant. The Company uses the Black-Scholes option pricing model to measure the fair value of stock options. This model requires estimates related to the award’s expected life and future stock price volatility of the underlying equity security. Actual compensation expense recognized over the vesting period will only be for those shares that vest.

The expected volatility is based on the annualized daily historical volatility of the Company’s stock price for a time period consistent with the expected term of each grant. Management believes that the historical volatility of the Company’s stock price best represents the future volatility of the stock price. The risk-free rate is based on the U.S. Treasury yield in effect at the time of grant for the expected term of the respective grant. The expected term is based on historical data. The Company has not historically paid cash dividends, and does not expect to pay cash dividends in the foreseeable future.

(n)Comprehensive Loss

Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other comprehensive income (loss) includes unrealized gains and losses arising during the period on available-for-sale securities.

(o)Segment Reporting

The Company has determined that it operates in a single reportable segment, which is the research and development of innovative drug candidates for the treatment of human cancer. See Note 14, Segment Information.

(p)Interest Expense on Liability related to the Sale of Future Royalties

In March 2019 the Company entered into the Oberland Purchase Agreement. Pursuant to the terms of the Oberland Purchase Agreement the Company sold to the Purchasers a portion of its rights to receive royalties from Genentech on potential net sales of Erivedge. As a result of the obligation to pay future royalties to the Purchasers, the Company recorded the proceeds as a liability in its Consolidated Balance Sheet that is accounted for using the interest method over the expected life of the Oberland Purchase Agreement. As a result, the Company imputes interest on the transaction and records imputed interest expense at the estimated interest rate. The Company's estimate of the interest rate under the Oberland Purchase Agreement is based on the amount of royalty payments expected to be received by the Purchasers over the life of the arrangement.

(q)Warrants

The Company accounts for warrants to purchase shares of its common stock in accordance with the guidance in FASB Codification Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and FASB Codification Topic 815, Derivatives and Hedging (“ASC 815”). The Company classifies warrants issued for the purchase of shares of its common stock as either equity or liability instruments based on an assessment of the specific terms and conditions of the contract. The assessment considers whether the warrants are freestanding financial instruments or embedded in a host instrument, and whether the warrants meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815. For warrants that meet all of the criteria for equity classification, the warrants are recorded as a component of equity without subsequent remeasurement at the time of issuance.

(r)New Accounting Pronouncements

Recently Adopted

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. The Company adopted this ASU for the fiscal year beginning January 1, 2024. See Note 14, Segment Information.

Issued, Not Yet Adopted

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the income tax disclosures within the Consolidated Financial Statements.

In November 2024, the FASB issued ASU-2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220): Disaggregation of Income Statement Expenses. The ASU requires additional disclosures of the nature of the expenses included in the income statement, including disaggregation of the expense captions presented on the Consolidated Statements of Operations into specific categories. ASU No. 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the Consolidated Financial Statement disclosures.

(3) Fair Value of Financial Instruments

The Company applies the provisions of FASB Codification 820, Fair Value Measurements (“ASC 820”) for its financial assets and liabilities that are re-measured and reported at fair value each reporting period and the non-financial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability. ASC 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows:

Level 1Quoted prices in active markets for identical assets or liabilities.
Level 2Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

In accordance with the fair value hierarchy, the following tables show the fair value as of December 31, 2024 and 2023 of those financial assets and liabilities that are measured at fair value on a recurring basis, according to the valuation techniques the Company used to determine their fair value.

Quoted Prices inActive Markets(Level 1)OtherObservableInputs(Level 2)UnobservableInputs(Level 3)Fair Value
(in thousands)
Assets:
Cash equivalents:
Money market funds$17,201$—$—$17,201
Total$17,201$—$—$17,201
Quoted Prices inActive Markets(Level 1)OtherObservableInputs(Level 2)UnobservableInputs(Level 3)Fair Value
(in thousands)
Assets:
Cash equivalents:
Money market funds$16,780$—$—$16,780
U.S. treasury securities and government agency obligations—4,735—4,735
Corporate debt securities and commercial paper—2,021—2,021
Short-term investments:
Corporate debt securities and commercial paper—12,996—12,996
U.S. treasury securities and government agency obligations—16,657—16,657
Total$16,780$36,409$—$53,189

(4)Investments

As of December 31, 2024, all of the Company's investments have matured.

The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2023 are as follows:

(in thousands)AmortizedCostUnrealizedGainUnrealizedLossFair Value
Short-term investments:
Corporate debt securities and commercial paper$12,999$—$(3)$12,996
U.S. treasury securities and government agency obligations16,6553(1)16,657
Total investments$29,654$3$(4)$29,653

The weighted average remaining maturity of short-term investments was 0.2 years at December 31, 2023.

No credit losses on available-for-sale securities were recognized during the year ended December 31, 2023. In its evaluation to determine expected credit losses, management considered all available historical and current information, expectations of future economic conditions, the type of security, the credit rating of the security, and the size of the loss position, as well as other relevant information. As of December 31, 2024, all of the Company's investments have matured.

As of December 31, 2023, the Company heldno investments that have been in a continuous unrealized loss position for 12 months or longer.

(5)Property and Equipment, Net

Property and equipment consisted of the following:

December 31,
(in thousands)20242023
Laboratory equipment, computers and software$77$1,140
Leasehold improvements257257
Office furniture and equipment9101,028
1,2442,425
Less—Accumulated depreciation and amortization(1,013)(1,991)
Property and equipment, net$231$434

Depreciation and amortization expense related to property and equipment was $0.2 million and $0.3 million for the years ended December 31, 2024 and 2023, respectively.

(6)Accrued Liabilities

Accrued liabilities consisted of the following:

December 31,
(in thousands)20242023
Employee related costs$3,255$3,701
Research and development costs3,0494,163
Professional and legal fees7711,059
Other36117
Total$7,111$9,040

(7)Leases and Commitments

(a)Operating Leases

The Company has a single lease for real estate, including laboratory and office space, and certain equipment, located at 128 Spring Street in Lexington, Massachusetts which commenced on May 1, 2020.

A portion of the Company’s leased space is subject to an early termination option that becomes effective on the lease commencement date of a new lease for larger premises within the landlord’s commercial real estate portfolio. The landlord had the option to early terminate the lease agreement by providing written notice to the Company eighteen months prior to December 31, 2025, or by June 30, 2024. The Company previously expected the lease to end as of December 31, 2025, and the Company no longer expects the lease to end early, which was accounted for as a lease modification. The lease will expire on April 30, 2027. During the year ended December 31, 2024, the Company recognized an increase of $1.4 million to the lease liability and right-of-use asset as a result of the lease modification.

The discount rate associated with the Company’s right-of-use asset is 10%. The total cash obligation for the base rent over theseven-year term of this lease is approximately $10.5 million, of which $1.5 million was paid during the year ended December 31, 2024.

The Company's lease is an operating lease. The following table summarizes the presentation in the Company's Consolidated Balance Sheet for the operating lease:

December 31,
(in thousands)20242023
Assets:
Operating lease right-of-use asset$3,163$3,056
Liabilities:
Operating lease liability - short-term$1,336$1,305
Operating lease liability - long-term1,6181,489
Total operating liability$2,954$2,794

The following table summarizes the effect of lease costs in our Consolidated Statements of Operations and Comprehensive Loss:

For the Year Ended December 31,
(in thousands)20242023
Operating lease cost
Research and development$844$483
General and administrative7221,182
Total$1,566$1,665

The Company’s lease payments through the end of the expected lease term are expected to be as follows:

Year Ending December 31,(in thousands)
20251,558
20261,287
2027433
Total lease payments$3,278
Less: interest324
Present value of operating lease liabilities$2,954

(b)License and Funding Agreements

In exchange for the right to use licensed technology in its research and development efforts, the Company has entered into various license agreements and funding agreements. These license agreements generally stipulate that the Company is obligated to pay royalties on future revenues, if any, resulting from use of the underlying licensed technology. Such revenues may include up-front license fees, contingent payments upon collaborators’ achievement of development and regulatory objectives, and royalties. In addition, some of the agreements commit the Company to make contractually defined payments upon the attainment of scientific or clinical milestones. The Company expenses these payments as they are incurred and expenses royalty payments as related future product sales or as royalty revenues are recorded. The Company accrues expenses for scientific and clinical objectives over the period that the work required to meet the respective objective is completed, provided that the Company believes that the achievement of such objective is probable.

(8)Liability Related to the Sale of Future Royalties

In March 2019, the Company and Curis Royalty entered into the royalty interest purchase agreement (“Oberland Purchase Agreement”) with TPC Investments I LP and TPC Investments II LP ("the Purchasers"), each of which is a Delaware limited partnership managed by Oberland Capital Management, LLC, and Lind SA LLC, a Delaware limited liability company managed by Oberland Capital Management, LLC, as collateral agent for the Purchasers. The Company sold to the Purchasers a portion of its rights to receive royalties from Genentech on potential net sales of Erivedge. Concurrently with the closing of the Oberland Purchase Agreement, Curis Royalty used a portion of the proceeds to terminate and repay the then existing loan with Healthcare Royalty Partners III, L.P.

As upfront consideration for the purchase of the royalty rights, the Purchasers paid to Curis Royalty $65.0 million less certain transaction expenses. Curis Royalty will also be entitled to receive up to $53.5 million in milestone payments based on sales of Erivedge if the Purchasers receive payments pursuant to the Oberland Purchase Agreement in excess of $117.0 million on or prior to December 31, 2026.

The Oberland Purchase Agreement provides that after the occurrence of an event of default as defined under the security agreement by Curis Royalty, the Purchasers shall have the option, for a period of 180 days, to require Curis Royalty to repurchase a portion of certain royalty and royalty related payments, excluding a portion of non-U.S. royalties retained by Curis Royalty ("Purchased Receivables"), at a price (the "Put/Call Price") equal to 250% of the sum of the upfront purchase price and any portion of the milestone payments paid in a lump sum by the Purchasers, if any, minus certain payments previously received by the Purchasers with respect to the Purchased Receivables. The Company concluded the put option is an embedded derivative that requires bifurcation from the deferred royalty obligation and evaluates the fair value of the put option each reporting period. The estimated fair value of the put option is immaterial as of both December 31, 2024 and 2023. Additionally, Curis Royalty shall have the option at any time to repurchase the Purchased Receivables at the Put/Call Price as of the date of such repurchase. No events of default occurred as of December 31, 2024.

As a result of the obligation to pay future royalties to the Purchasers, the Company recorded the proceeds as a liability on its Consolidated Balance Sheets. It accounts for the liability and interest expense using the interest method over the expected life of the Oberland Purchase Agreement. As a result, the Company imputes interest on the transaction and records imputed interest expense at the estimated interest rate. The Company's estimate of the interest rate under the Oberland Purchase Agreement is based on the amount of royalty payments expected to be received by the Purchasers over the life of the Oberland Purchase Agreement. The projected amount of royalty payments expected to be paid to the Purchasers involves the use of significant estimates and assumptions with respect to the revenue growth rate in the Company's projections of sales of Erivedge. The Company periodically assesses the expected royalty payments to Curis Royalty from Genentech using a combination of historical results and forecasts from market data sources. To the extent such payments are greater or less than its estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability.

The Company determined the fair value of the liability related to the sale of future royalties at the time of the Oberland Purchase Agreement to be $65.0 million. The Company uses the prospective method to impute interest on this obligation. Under the prospective method, the current effective annual imputed interest rate is 6.2% as of December 31, 2024. The carrying value of the liability related to the sale of future royalties approximates fair value as of December 31, 2024. The Company incurred $0.6 million of transaction costs in connection with the Oberland Purchase Agreement. These transaction costs will be amortized to imputed interest expense over the estimated term of the Oberland Purchase Agreement.

The following table shows the activity with respect to the liability related to the sale of future royalties during the years ended December 31, 2023 and 2024:

(in thousands)
Carrying value of liability related to the sale of future royalties at January 1, 2023$49,483
Imputed interest expense2,138
Other(119)
Less: payments to the Purchasers(8,896)
Carrying value of liability related to the sale of future royalties at December 31, 2023$42,606
Imputed interest expense559
Other56
Less: payments to the Purchasers(9,047)
Carrying value of liability related to the sale of future royalties at December 31, 2024$34,174

The Company has revised the balance sheet classification of the liability related to the sale of future royalties, net to adjust for an immaterial reclassification of the presentation of this liability between long term and short term. A summary of adjustments as of December 31, 2023 are as follows:

As Previously reportedAdjustmentAs Revised
Current portion of liability related to sale of future royalties—8,5048,504
Liability related to sale of future royalties, net42,606(8,504)34,102

The revisions increased total current liabilities by the amounts noted above and have no impact on total liabilities for any of the periods presented. The revisions did not impact the Consolidated Statement of Operations and Comprehensive Loss, the Consolidated Statement of Cash Flows, or the Consolidated Statement of Stockholders' Equity (Deficit).

(9)Common Stock

(a)Charter Amendments

In September 2023, the Company's stockholders approved an increase to the number of authorized shares of its common stock from 11,390,625 shares to 22,781,250 shares.

In May 2024, the Company's stockholders approved an increase to the number of authorized shares of its common stock from 22,781,250 shares to 34,171,875 shares.

(b)Sales Agreement with Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC

In February 2024, the Company entered into an amended and restated sales agreement with Cantor Fitzgerald & Co. (“Cantor”) and JonesTrading Institutional Services LLC (“JonesTrading”) (the “2024 Sales Agreement”). Pursuant to the 2024 Sales Agreement, the Company can sell from time to time up to $100.0 million shares of the Company’s common stock through an “at-the-market offering” program under which Cantor and JonesTrading act as sales agents. Subject to the terms and conditions of the 2024 Sales Agreement, Cantor and JonesTrading can sell the common stock by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

Pursuant to the terms of the 2024 Sales Agreement, the aggregate compensation payable to each of Cantor and JonesTrading is 3% of the gross proceeds from sales of the common stock sold by Cantor or JonesTrading, as applicable. The Company sold 188,316 shares of common stock under the 2024 Sales Agreement representing gross proceeds of $1.2 million during the year ended December 31, 2024. As of December 31, 2024, $98.8 million of shares of common stock remained available for sale under the 2024 Sales Agreement.

(c)2023 Registered Direct Offering

In July 2023, the Company sold and issued, in a registered direct offering (the “July Registered Direct”) to certain institutional investors, an aggregate of 920,488 shares of common stock at a purchase price per share of $16.40 per share for net proceeds of approximately $13.8 million.

(d)October 2024 Offerings

In October 2024, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company issued and sold: (i) in a registered direct offering,2,398,414 shares of the Company's common stock and (ii) in a concurrent private placement, warrants to purchase up to an aggregate of 2,398,414 shares of the Company's common stock (the “Warrants”), at an exercise price of $4.92 per share. The registered direct offering and concurrent private placement are collectively referred to as the "October 2024 Offerings". The Warrants were exercisable immediately upon closing on October 30, 2024 and will expire five years following the issuance date. The combined purchase price for one share of common stock and the associated Warrant was $5.045. The net proceeds to the Company from the October 2024 Offerings were approximately $10.8 million, excluding the proceeds from any exercise of the Warrants.

The Company concluded the Warrants meet the equity scope exception under ASC 815-40. The total net proceeds were allocated to common stock and the Warrants based on the relative fair value. The relative fair value of the common stock and Warrants were $6.0 million and $4.8 million, respectively.

The Company calculated the fair value of the Warrants using the Black-Scholes option pricing model with the following weighted average inputs:

October 28 , 2024 (Issuance Date)
Stock price$4.92
Expected term (years)4.78
Risk-free interest rate4.1%
Expected volatility117%
Expected dividend yieldNone

(e)March 2025 Offerings

In March 2025, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue: (i) in a registered direct offering,1,974,432 shares of the Company’s common stock and (ii) in a concurrent private placement, (a) in lieu of shares to certain investors, unregistered pre-funded warrants to purchase up to an aggregate of 2,184,009 shares of common stock (the “Pre-Funded Warrants”), at an exercise price of $0.01 per share, and (b) unregistered warrants (the “Common Warrants” and together with the Pre-Funded Warrants, the “Unregistered Warrants”) to purchase up to an aggregate of 8,316,882 shares of common stock, at an exercise price of $2.41 per share. Each Common Warrant will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of Common Stock upon exercise of the Common Warrants and will have a term offive years from the date of issuance. Each Pre-Funded Warrant will be exercisable immediately upon issuance and continuing through and including the date the Pre-Funded Warrant is exercised in full. The combined purchase price for one share of the Company's common stock and the associated Common Warrant is $2.41. The combined purchase price for one Pre-Funded Warrant and the associated Common Warrant is $2.40. The aggregate gross proceeds to the Company from the Offerings were approximately $10.0 million, before deducting fees payable to the placement agent, advisory fees and other estimated offering expenses payable by the Company, and excluding the proceeds from any exercise of the Unregistered Warrants.

(10)Research and Development Collaborations

(a)Genentech

In June 2003, the Company licensed its proprietary Hedgehog pathway antagonist technologies to Genentech for human therapeutic use. The primary focus of the collaborative research plan has been to develop molecules that inhibit the Hedgehog pathway for the treatment of various cancers. The collaboration is currently focused on the development of Erivedge, which is being commercialized by Genentech in the U.S. and by Genentech's parent company, Roche, outside of the U.S. for the treatment of advanced BCC. Pursuant to the collaboration agreement, the Company is eligible to receive up to an aggregate of $115.0 million in contingent cash milestone payments, exclusive of royalty payments, in connection with the development of Erivedge or another small molecule Hedgehog pathway inhibitor, assuming the successful achievement by Genentech and

Roche of specified clinical development and regulatory objectives. Of this amount, the Company has received $59.0 million in cash milestone payments as of December 31, 2024.

In addition to these payments and pursuant to the collaboration agreement, the Company is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5%. The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances.

The Company recognized $10.9 million and $9.9 million in royalty revenues under the Genentech collaboration during the years ended December 31, 2024 and 2023, respectively. Cost of royalties comprises payments to university licensors and was not material for the years ended December 31, 2024 and 2023.

The Company has accounts receivable from Genentech under this collaboration of $3.3 million and $2.7 million as of December 31, 2024 and 2023, respectively, in its Consolidated Balance Sheets.

As further discussed in Note 8, Liability Related to the Sales of Future Royalties, a significant portion of royalty revenues received from Genentech on net sales of Erivedge will be paid to the Purchasers pursuant to the Oberland Purchase Agreement.

(b)Aurigene

In January 2015, the Company entered into an exclusive collaboration agreement with Aurigene for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and selected precision oncology targets. Under the collaboration agreement, Aurigene granted the Company an option to obtain exclusive, royalty-bearing licenses to relevant Aurigene technology to develop, manufacture and commercialize products containing certain of such compounds anywhere in the world, except for India and Russia, which are territories retained by Aurigene.

In September 2016, the Company and Aurigene entered into an amendment to the collaboration agreement. Under the terms of the amendment, in exchange for the issuance of shares of the Company's common stock, Aurigene waived payment of up to a total of $24.5 million in potential milestones and other payments associated with the first four programs in the collaboration that may have become due from the Company under the collaboration agreement. To the extent any of these waived milestones or other payments are not payable by the Company, for example in the event one or more of the milestone events do not occur, the Company will have the right to deduct the unused waived amount from any one or more of the milestone payment obligations tied to achievement of commercial milestone events. The amendment also provides that, in the event supplemental program activities are performed by Aurigene, the Company will provide up to $2.0 million of additional funding for each of the two licensed programs besides the IRAK4 licensed program.

In February 2020, the Company and Aurigene further amended their collaboration agreement. Under the terms of the amended agreement, Aurigene expanded their rights to develop and commercialize CA-170 to Asia and will conduct a Phase 2b/3 randomized study evaluating CA-170, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In September 2024, the collaboration agreement was further amended to expand Aurigene's rights to develop and commercialize CA-170 worldwide. The Company is entitled to receive royalty payments on potential future sales of CA-170 at percentage rates ranging from the high single digits up to 10%, subject to specified reductions. In addition, the Company is entitled to receive a low double-digit percentage of Aurigene’s sublicensing revenues subject to specified reductions.

As of December 31, 2024, the Company has licensed the following programs under the collaboration:

IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is emavusertib.

PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327.

An immuno-oncology program.

For each of the IRAK4, PD1/TIM3, and the immuno-oncology programs the Company is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at leastone product in each of the U.S., specified countries in the European Union and Japan. Aurigene is obligated to use commercially reasonable efforts to perform its obligations under the development plan for its licensed programs.

For each of the IRAK4, PD1/TIM3, and the immuno-oncology programs, the Company has remaining unpaid or unwaived payment obligations of $42.5 million per program, related to regulatory approval and commercial sales milestones, plus specified additional payments for approvals for additional indications, if any.

(11) Stock Plans and Stock-Based Compensation

As of December 31, 2024, the Company hadtwo shareholder-approved, stock-based compensation plans: (i) the Fifth Amended and Restated 2010 Stock Incentive Plan (“2010 Plan”) and (ii) the Amended and Restated 2010 Employee Stock Purchase Plan, (“ESPP”). New employees are generally issued options as an inducement equity award under Nasdaq Listing Rule 5635(c)(4) outside of the 2010 Plan (“Inducement Awards”).

The Fifth Amended and Restated 2010 Stock Incentive Plan

The 2010 Plan permits the granting of incentive and non-qualified stock options and stock awards to employees, officers, directors, and consultants of the Company and its subsidiaries at prices determined by the Company’s board of directors. In May 2024, the Company's stockholders approved the amendment and restatement of the 2010 Plan to reserve an additional 942,100 shares of common stock for issuance under the 2010 Plan. The Company can issue up to 2,101,600 shares of its common stock pursuant to awards granted under the 2010 Plan. Options vest and become exercisable based on a schedule determined by the board of directors and expire up toten years from the date of grant. The 2010 Plan uses a “fungible share” concept under which each share of stock subject to awards granted as options and stock appreciation rights (“SARs”), will causeone share per share under the award to be removed from the available share pool, while each share of stock subject to awards granted as restricted stock, restricted stock units, other stock-based awards or performance awards where the price charged for the award is less than 100% of the fair market value of the Company’s common stock will cause 1.3 shares per share under the award to be removed from the available share pool. As of December 31, 2024, the Company has only granted options to purchase shares of the Company’s common stock with an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Capital Market on the grant date and issued restricted stock awards at no cost to Company employees, excluding officers.

During the year ended December 31, 2024, the Company’s board of directors granted options to purchase 457,670 shares of the Company’s common stock to officers and employees of the Company under the 2010 Plan. These options vest and become exercisable as to 25% of the shares underlying the award after the first year and as to an additional 6.25% of the shares underlying the award in each subsequent quarter, based upon continued employment over afour-year period, and are exercisable at a price equal to the closing price of the Company’s common stock on the grant date.

During the year ended December 31, 2024, the Company’s board of directors granted options to its non-employee directors to purchase 21,250 shares of common stock under the 2010 Plan, which will vest and become exercisable inone year from the date of grant. These options were granted at an exercise price that equaled the closing market price of the Company’s common stock on the grant date.

During the year ended December 31, 2023, the Company’s board of directors granted restricted stock awards ("RSAs"), for an aggregate amount of 117,000 shares to the employees of the Company, excluding officers, under the 2010 Plan. These RSAs vest as to 50% of the shares underlying the award on the first anniversary of the date of the grant and 50% after the second anniversary, based upon continued employment.

As of December 31, 2024,912,598 shares remained available for grant under the 2010 Plan.

Inducement Awards

The Company grants Inducement Awards to certain new employees. These options generally vest as to 25% of the shares underlying the option on the first anniversary of the grant date, and as to an additional 6.25% of the shares underlying the option on each successive quarter thereafter. During the year ended December 31, 2024, the Company’s board of directors granted Inducement Awards to purchase 39,350 shares of common stock. These options were granted at an exercise price that equaled the closing market price of the Company’s common stock on grant date.

Stock Options

A summary of stock option activity under the 2010 Plan and Inducement Awards are summarized as follows:

Number ofOptionsWeightedAverageExercisePrice perShareWeightedAverageRemaining Contractual LifeAggregate Intrinsic Value (000's)
Outstanding, December 31, 2023840,880$47.587.16$91
Granted518,27011.39
Exercised——
Canceled(198,899)45.82
Outstanding, December 31, 20241,160,251$33.447.19$—
Exercisable at December 31, 2024575,688$55.365.50$—
Vested and unvested expected to vest at December 31, 20241,160,251$33.447.19$—

The weighted average grant date fair values of stock options granted during the years ended December 31, 2024 and 2023 were $9.50 and $11.70, respectively, and were calculated usingthe following estimated assumptions under the Black-Scholes option pricing model:

For the Year EndedDecember 31,
20242023
Expected term (years)6.05.5
Risk-free interest rate3.9-4.5%3.5-4.7%
Expected volatility114-116%115-116%
Expected dividend yieldNoneNone

As of December 31, 2024, there was approximately $5.7 million of unrecognized compensation cost related to unvested employee stock option awards outstanding, which is expected to be recognized as expense over a weighted average period of 2.3 years. There wereno employee stock options exercised during the year ended December 31, 2024.

Restricted Stock Awards

The following table presents a summary of outstanding RSAs under the 2010 Plan as of December 31, 2024:

Number ofSharesWeightedAverageGrant Date Fair Value
Unvested, December 31, 2023110,500$18.20
Awarded——
Vested(65,988)18.20
Forfeited(4,375)18.20
Unvested, December 31, 202440,137$18.20

As of December 31, 2024, there were 40,137 shares outstanding underlying RSAs that are expected to vest. As of December 31, 2024, there was $0.3 million of unrecognized compensation costs related to RSAs, which are expected to be recognized as expense over a remaining weighted average period of 0.4 years. The fair value of RSAs that vested during the year ended December 31, 2024 was $1.0 million. There wereno RSAs that vested during the year ended December 31, 2023. The weighted average grant date fair value of RSAs granted during the year ended December 31, 2023 was $18.20.

Amended and Restated 2010 Employee Stock Purchase Plan

In May 2024, the Company's stockholders approved an amendment to the ESPP to reserve an additional 400,000 shares of common stock for issuance under the ESPP. The Company has reserved 500,000 shares of common stock for issuance under the ESPP. Eligible employees may purchase shares of the Company’s common stock at 85% of the lower closing market price of the common stock at the beginning of the enrollment period or ending date of the any purchase period within atwo-year enrollment period, as defined. The Company hasfour six-month purchase periods per eachtwo-year enrollment period. If, within any one of thefour purchase periods in an enrollment period, the purchase period ending stock price is lower than the stock price at the beginning of the enrollment period, thetwo-year enrollment resets at the new lower stock price. During the year ended December 31, 2024,32,168 shares were issued under the ESPP. As of December 31, 2024, there were 394,463 shares available for future purchase under the ESPP.

For the years ended December 31, 2024 and 2023, the Company recorded compensation expense related to its ESPP and calculated the fair value of shares expected to be purchased under the ESPP using the Black-Scholes model.

Stock-Based Compensation Expense

For the years ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense to the following line items in its costs and expenses section of the Consolidated Statements of Operations and Comprehensive Loss:

For the Year Ended December 31,
20242023
Research and development expenses$2,760$2,770
General and administrative expenses3,1673,230
Total stock-based compensation expense$5,927$6,000

No income tax benefits have been recorded for the years ended December 31, 2024 and 2023, as the Company has recorded a full valuation allowance and management has concluded that it is more likely than not that the net deferred tax assets will not be realized (see Note 13, Income Taxes).

(12)Retirement Savings Plan

The Company has a 401(k) retirement savings plan covering substantially all of the Company’s employees. The Company made matching contributions of $0.6 million during each of the years ended December 31, 2024 and 2023.

(13)Income Taxes

For the years ended December 31, 2024 and 2023, the Company did not record any federal or state income tax expense given its continued operating losses, all of which were attributable to the United States.

A reconciliation between income tax benefit and the expected tax benefit at the statutory rate for the years ended December 31, 2024 and 2023 are as follows:

For the Year EndedDecember 31,
20242023
Statutory federal income tax rate21.0%21.0%
State income taxes, net of federal benefit5.9%6.1%
Research and development tax credits4.3%3.7%
Orphan drug tax credits4.4%4.9%
Expiration of NOLs/credits(6.1)%(6.3)%
Other(0.3)%1.5%
Stock based compensation(1.7)%(2.5)%
Change in valuation allowance(27.5)%(28.4)%
Effective income tax rate—%—%

The principal components of the Company’s deferred tax assets at December 31, 2024 and December 31, 2023, respectively, are as follows:

December 31,
20242023
Deferred Tax Assets:
NOL carryforwards$104,122$91,036
Research and development tax credit carryforwards18,22016,973
Orphan drug tax credit carryforwards26,88524,983
Depreciation and amortization4,5975,552
Capitalized research and development expenditures41,28342,271
Stock options5,5714,857
Accrued expenses and other154973
Oberland agreement9,33611,640
Lease liability807763
Total gross deferred tax asset210,975199,048
Valuation allowance(210,112)(198,212)
Net deferred tax asset$863$836
Deferred tax liabilities:
Right of use asset(863)(836)
Total gross deferred tax liabilities$(863)$(836)
Net deferred tax assets (liabilities)$—$—

As of December 31, 2024, the Company had U.S. federal tax-effected net operating loss carryforwards of $84.5 million, of which $32.1 million will expire in years 2025 through 2037 and the remainder do not expire but are subject to 80% limitation. As of December 31, 2024, the Company had state net operating loss carryforwards of $19.6 million that will expire between years 2033 and 2044.

As of December 31, 2024 and 2023, the Company had federal research and development credit carryforwards of $14.0 million and $12.9 million, respectively. The credits will expire in the years 2025 through 2044. As of December 31, 2024 and 2023, the Company had state research and development credit carryforwards of $4.2 million and $4.1 million, respectively. The credits will expire in the years 2025 through 2039, unless previously utilized.

As of December 31, 2024 and 2023, the Company had orphan drug tax credit carryforwards of $26.9 million and $25.0 million, respectively. These credits, if any, relate to qualified expenses incurred for fimepinostat and emavusertib since receiving the Orphan Drug designation. The credits will expire in the years 2035 through 2044.

As of December 31, 2024 and 2023, the Company had deferred tax assets associated with the capitalization of Section 174 costs of $21.8 million and $16.9 million, respectively, which were included in capitalized research and development expenditures in the table above.

The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, and has determined that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. Accordingly, the Company had a valuation allowance of approximately $210.1 million and $198.2 million as of December 31, 2024 and 2023, respectively. The valuation allowance increased approximately $11.9 million and $13.5 million during the years ended December 31, 2024 and 2023.

Utilization of the NOL may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a §382 study in 2019 and determined no ownership changes have occurred and no limitation on NOLs through December 31, 2018. There could be additional ownership changes in the future, which may result in additional limitations in the utilization of the carryforward NOLs and credits, and the Company does not expect to have any taxable income for the foreseeable future.

An individual tax position must satisfy for some or all of the benefits of that position to be recognized in a company’s financial statements. At December 31, 2024 and 2023, the Company hadno unrecognized tax benefits. The Company has not, as yet, conducted a study of its R&D credit carryforwards. This study may result in an adjustment to the Company’s R&D credit carryforwards, however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position under FASB Codification Topic 740 Income Taxes. A full valuation allowance has been provided against the Company’s R&D credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the Consolidated Balance Sheets or Consolidated Statements of Operations and Comprehensive Loss if an adjustment were required.

As of December 31, 2024, the Company is generally no longer subject to examination by taxing authorities for years prior to 2021. However, NOL’s and credits in the United States may be subject to adjustments by taxing authorities in future years in which they are utilized. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years. The Company recognizes both accrued interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded any interest or penalties on any unrecognized tax benefits since its inception.

(14)Segment Information

The Company has determined that it operates in a single reportable segment, which is the research and development of innovative drug candidates for the treatment of human cancer. Resources are allocated and performance is assessed by the Company's President and Chief Executive Officer, whom the Company has determined to be its Chief Operating Decision Maker (CODM).

The CODM considers actual operating results on an annual basis on a consolidated basis, including consolidated net loss, when making decisions about allocating capital and personnel to the segment in the annual budgeting and forecasting process, which includes comparison of budget to actual and current period to prior period variances. The CODM assesses performance for the operating segment and decides, in part, how to allocate resources based on net loss that also is reported on the Consolidated Statement of Operations as net loss. The measure of segment assets is reported on the Consolidated Balance Sheets as total assets.

In addition to the significant categories included within net loss presented on the Company's Consolidated Statement of Operations, the following table is representative of the significant expense categories for the years ended December 31, 2024 and 2023, including a reconciliation to Net Loss:

For the Year EndedDecember 31,
20242023
Revenues, net$10,908$10,023
Direct research and development expenses22,24623,078
Research and development employee related costs14,49914,330
General and administrative employee related costs8,7229,171
Professional, legal, and consulting costs4,8105,598
Other segment items (1)4,0205,259
Net loss$(43,389)$(47,413)

(1) Other operating expenses for the reportable segment includes cost of royalties, facility related costs, insurance costs, and other income.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.