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CURIS INC

For the period ended Dec 31, 2023. Filed Feb 8, 2024.

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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.

FY2023 · Filed Feb 8, 2024

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

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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, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity 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, 2023 and 2022, 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 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.

Liability Related to the Sale of Future Royalties

As described in Note 8 to the consolidated financial statements, the Company entered into a royalty interest purchase agreement (“Oberland Purchase Agreement”) in 2019 with entities managed by Oberland Capital Management, LLC (“the Purchasers”). 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, management recorded the proceeds from this transaction as a liability on its consolidated balance sheet accounted for using the interest method over the estimated life of the Oberland Purchase Agreement. Management 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. As of December 31, 2023, the liability related to the sale of future royalties was $42.6 million. 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 principal considerations for our determination that performing procedures relating to the liability related to the sale of future royalties is a critical audit matter are the (i) high degree of auditor judgment and subjectivity in applying procedures relating to the fair value measurement of the liability due to the significant amount of judgment by management when developing the estimate and (ii) significant audit effort in evaluating the revenue growth rate and in evaluating the audit evidence obtained.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. These procedures included, among others, testing management’s process for estimating the fair value of the liability related to the sale of future royalties and testing management’s cash flow projections used to estimate the fair value of the liability. Testing management’s process included evaluating the appropriateness of the valuation method, testing the completeness and accuracy of data provided by management, and evaluating the reasonableness of the revenue growth rate significant assumption. Evaluating the reasonableness of the revenue growth rate involved (i) testing historical royalty payments received from Genentech, (ii) confirming information and amounts directly with Genentech, including evaluating this information for consistency with the contractual terms of the agreement, and (iii) testing management’s process for estimating future Erivedge sales by comparing prior period revenue estimates to actual revenue amounts based on payments received.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts

February 8, 2024

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

Consolidated Balance Sheets

(In thousands, except share and per share data)

December 31,
20232022
ASSETS
Current assets:
Cash and cash equivalents$26,681$19,658
Short-term investments29,65365,965
Accounts receivable2,7942,975
Prepaid expenses and other current assets1,7803,521
Total current assets60,90892,119
Property and equipment, net434689
Restricted cash, long-term544635
Operating lease right-of-use asset3,0564,401
Other assets3,3582,022
Goodwill8,9828,982
Total assets$77,282$108,848
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$3,172$3,193
Accrued liabilities9,0405,679
Current portion of operating lease liability1,3051,141
Total current liabilities13,51710,013
Long-term operating lease liability1,4892,800
Liability related to the sale of future royalties, net42,60649,483
Total liabilities57,61262,296
Stockholders’ equity:
Preferred stock, $0.01 par value—5,000,000 shares authorized, no shares issued and outstanding at December 31, 2023 and 2022——
Common stock, $0.01 par value—22,781,250 shares authorized, 5,894,085 shares issued and outstanding at December 31, 2023; 11,390,625 shares authorized, 4,830,464 shares issued and outstanding at December 31, 20225948
Additional paid-in capital1,215,7921,195,687
Accumulated deficit(1,196,410)(1,148,997)
Accumulated other comprehensive gain (loss)229(186)
Total stockholders’ equity19,67046,552
Total liabilities and stockholders’ equity$77,282$108,848

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

Years Ended December 31,
20232022
Revenues, net$10,023$10,162
Operating expenses:
Cost of royalties212257
Research and development39,49643,277
General and administrative18,64719,648
Total operating expenses58,35563,182
Loss from operations(48,332)(53,020)
Other income (expense):
Interest income2,9381,119
Expense related to the sale of future royalties(2,019)(4,771)
Total other income (expense)919(3,652)
Net loss$(47,413)$(56,672)
Net loss per common share (basic and diluted)$(8.96)$(12.14)
Weighted average common shares (basic and diluted)5,293,2944,669,626
Net Loss$(47,413)$(56,672)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities415(77)
Comprehensive loss$(46,998)$(56,749)

Consolidated Statements of Stockholders’ Equity

(In thousands, except share data)

Common Stock · AdditionalPaid-inCapital · AccumulatedDeficit · AccumulatedOtherComprehensiveGain (Loss) · TotalStockholders’Equity
Shares · Amount
December 31, 20214,582,353$46$1,183,095$(1,092,325)$(109)$90,707
Issuance of common stock in connection with 2021 Sales Agreement, net of fees of $0.7 million229,18525,592——5,594
Stock-based compensation——6,752——6,752
Issuance of common stock under employee benefit plans18,926—248——248
Unrealized loss on marketable securities————(77)(77)
Net loss———(56,672)—(56,672)
December 31, 20224,830,464$48$1,195,687$(1,148,997)$(186)$46,552
Issuance of common stock in connection with July Registered Direct, net of fees of $1.3 million920,488913,805——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

Consolidated Statements of Cash Flows

(In thousands)

Years Ended December 31,
20232022
Cash flows from operating activities:
Net loss$(47,413)$(56,672)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization255233
Non-cash lease expense1,3441,158
Stock-based compensation expense6,0006,752
Non-cash activity related to the sale of future royalties(340)659
Amortization of premiums and discounts on investments(1,059)351
Changes in operating assets and liabilities:
Accounts receivable181249
Prepaid expenses and other assets405(2,276)
Accounts payable and accrued and other liabilities3,340(3,884)
Operating lease liability(1,147)(907)
Total adjustments8,9792,335
Net cash used in operating activities(38,434)(54,337)
Cash flows from investing activities:
Purchases of investments(70,340)(62,000)
Sales and maturities of investments108,12695,439
Purchases of property and equipment—(416)
Net cash provided by investing activities37,78633,023
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs14,1175,842
Payment of liability of future royalties, net of imputed interest(6,537)(4,975)
Net cash provided by financing activities7,580867
Net increase (decrease) in cash and cash equivalents and restricted cash6,932(20,447)
Cash and cash equivalents and restricted cash, beginning of period20,29340,740
Cash and cash equivalents and restricted cash, end of period$27,225$20,293
Supplemental cash flow data:
Cash paid for interest2,3594,112
Decrease in right-of-use assets and operating lease liabilities resulting from lease modification—191

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,” “Curis,” “we,” “us,” or “our.”

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 entities managed by Oberland Capital Management, LLC (the “Purchasers”), and Lind SA LLC (the “Agent”), 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 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, 2023 and incurred a net loss of $47.4 million and used $38.4 million of cash in operations for the year ended December 31, 2023. 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 $56.3 million of existing cash, cash equivalents and investments at December 31, 2023, 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 our 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 as needed. 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 may have a material adverse effect on the Company’s operations and future prospects.

(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.

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.

On September 28, 2023, the Company effected a 1-for-20 reverse stock split of its common stock (“the Reverse Stock Split”). All references to shares of common stock outstanding, average number of shares outstanding and per share amounts in these consolidated financial statements and notes to consolidated financial statements have been restated to reflect the Reverse Stock Split on a retroactive basis.

(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 investments and 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. All other investments are marketable securities.

The Company separately classified $0.5 million and $0.6 million of its cash as restricted cash, long-term as of December 31, 2023 and 2022, respectively. These amounts represent the security deposit associated with the Company's Lexington, Massachusetts headquarters.

The Company’s short-term investments are 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 consist of commercial paper, corporate bonds and notes, and/or government obligations. All of the Company’s investments have been 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 (expense) in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income.

(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, marketable securities, 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 credit risk related to investments is reduced as a result of the Company’s policy to limit the amount invested in any one issue.

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 99% and 100% of the total gross revenues for the years ended December 31, 2023 and 2022, respectively.

The Company’s accounts receivable at December 31, 2023 and December 31, 2022 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 an impairment based on the difference between the carrying value and fair value of the asset. The Company did not recognize any material impairment charges for the years ended December 31, 2023 or December 31, 2022.

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, 2023 and 2022. 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, 2023 and 2022, 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

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) costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants; (3) other outside service including regulatory and costs of contract manufacturing; (4) the cost of companion drugs; (5) facility costs; and (6) certain payments that we make under our collaboration agreements. The Company expenses research and development costs as they are incurred.

(k)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 840,880 and 683,666 as of December 31, 2023 and 2022, respectively and unvested restricted stock awards of 110,500 as of December 31, 2023.

(l)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 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 Company has not historically paid cash dividends, and does not expect to pay cash dividends in the foreseeable future.

(m)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.

(n)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.

(o)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.

(p)New Accounting Pronouncements

Issued, Not Yet 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. Early adoption is permitted, and the amendments should be applied retrospectively. The Company is currently evaluating the impact of the ASU on the consolidated financial statement disclosures.

In December 2023, the FASB issued ASU No. 2023-09, 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.

(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, 2023 and 2022 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)
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
Quoted Prices inActive Markets(Level 1)OtherObservableInputs(Level 2)UnobservableInputs(Level 3)Fair Value
(in thousands)
Cash equivalents:
Money market funds$15,215$—$—$15,215
U.S. treasury securities and government agency obligations—2,998—2,998
Short-term investments:
Corporate debt securities and commercial paper—42,071—42,071
U.S. treasury securities and government agency obligations—23,894—23,894
Total assets at fair value$15,215$68,963$—$84,178

Accrued interest receivable on the Company's available-for-sale debt securities totaled $0.1 million and $0.2 million as of December 31, 2023 and 2022, respectively.

(4)Investments

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.

The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2022 are as follows:

(in thousands)AmortizedCostUnrealizedGainUnrealizedLossFair Value
Short-term investments:
Corporate debt securities and commercial paper$42,109$2$(40)$42,071
U.S. treasury securities and government agency obligations24,042—(148)23,894
Total investments$66,151$2$(188)$65,965

The weighted average remaining maturity of short-term investments was 0.3 years at December 31, 2022.

No credit losses on available-for-sale securities were recognized during the years ended December 31, 2023 and 2022. 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. The Company does not intend to sell, and is unlikely to be required to sell, any of these available-for-sale investments before their effective maturity or market price recovery.

As of December 31, 2023, the Company heldno investments that have been in a continuous unrealized loss position for 12 months or longer. The aggregate fair value of available-for-sale investments in a continuous unrealized loss position for 12 months or longer as of December 31, 2022 was $27.4 million.

(5)Property and Equipment, Net

Property and equipment consisted of the following:

December 31,
(in thousands)20232022
Laboratory equipment, computers and software$1,140$1,776
Leasehold improvements257257
Office furniture and equipment1,0281,113
2,4253,146
Less—Accumulated depreciation and amortization(1,991)(2,457)
Property and equipment, net$434$689

Depreciation and amortization expense related to property and equipment was $0.3 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively.

(6)Accrued Liabilities

Accrued liabilities consisted of the following:

December 31,
(in thousands)20232022
Headcount related costs$3,701$3,152
Research and development costs4,1631,727
Professional and legal fees1,059762
Other11738
Total$9,040$5,679

(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.

In January 2022, the Company amended its lease agreement for 128 Spring Street ("Lease Amendment") and the Lease Amendment commenced during the second quarter of 2022. The Lease Amendment added approximately 9,340 square feet to the existing space for $30 per square foot, or $0.3 million per year in base rent subject to annual rent increases. The Lease Amendment provides the Company and the landlord each with an option to terminate the lease agreement before the original lease term expires on April 30, 2027. The Company's early termination option becomes effective on the lease commencement date of a new lease for larger premises within the landlord’s commercial real estate portfolio (“New Lease”), and the Company may exercise its early termination option by providing the landlord with written notice of such election to terminate the lease agreement concurrently with the execution of the New Lease. The landlord has the option to early terminate the lease agreement by providing written notice to the Company eighteen months prior to December 31, 2025, or June 30, 2024. The Company expects the lease to end as of December 31, 2025.

The Lease Amendment constituted a modification as it reduces the original lease term and increases the scope of the lease (additional space provided under the Lease Amendment), and required evaluation of the remeasurement of the lease liability and corresponding right-of-use asset. The additional space did not result in a separate contract as the rent increase was determined not to be commensurate with the standalone price for the additional right of use. Accordingly, the Company reassessed the classification of the lease, and concluded it continues to be an operating lease, and remeasured the lease liability on the basis of the reduced lease term as of the effective date of the modification.

The shortened lease term and resulting remeasurement for the modification resulted in a decrease to the lease liability and the right-of-use asset. The additional space provided under the Lease Amendment and resulting remeasurement for the modification resulted in an increase to the lease liability and the right-of-use asset. During the year ended December 31, 2022, the Company recognized a net decrease of $0.2 million to the lease liability and right-of-use asset as a result of the modification.

The discount rate associated with the Company’s right-of-use asset is 10%. The total cash obligation for the base rent over thesix-year term of this lease is approximately $8.8 million, of which $1.5 million was paid during the year ended December 31, 2023.

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)20232022
Assets:
Operating lease right-of-use asset$3,056$4,401
Liabilities:
Operating lease liability - short-term$1,305$1,141
Operating lease liability - long-term1,4892,800
Total operating liability$2,794$3,941

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)20232022
Operating lease cost
Research and development$483$1,187
General and administrative1,182382
Total$1,665$1,569

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)
20241,512
20251,558
Total lease payments$3,070
Less: interest276
Present value of operating lease liabilities$2,794

(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. For the years ended December 31, 2023 and 2022, the Company also recognized $0.2 million and $0.3 million, respectively, as cost of royalty revenues in its consolidated statements of operations and comprehensive loss (see Note 10(a), Research and Development Collaborations - Genentech).

(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, 2023 and 2022. 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, 2023.

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 initial 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, with a current effective annual imputed interest rate of 1.5%. 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 carrying value of the liability related to the sale of future royalties approximates fair value as of December 31, 2023 and is based on the Company's current estimates of future royalties expected to be paid the Purchasers over the life of the arrangement, which are considered Level 3 inputs.

The following table shows the activity with respect to the liability related to the sale of future royalties during the years ended December 31, 2022 and 2023:

(in thousands)
Carrying value of liability related to the sale of future royalties at January 1, 2022$53,798
Other739
Imputed interest expense4,033
Less: payments to the Purchasers(9,087)
Carrying value of liability related to the sale of future royalties at December 31, 2022$49,483
Other(119)
Imputed interest expense2,138
Less: payments to the Purchasers(8,896)
Carrying value of liability related to the sale of future royalties at December 31, 2023$42,606

In March 2023, Curis and Curis Royalty received a letter from counsel to Oberland Capital Management, LLC, the Purchasers and the Agent alleging defaults under Sections 4.04 and 6.04(b) of the Oberland Purchase Agreement and demanding cure of the asserted default under Section 6.04(b) of the Oberland Purchase Agreement. The asserted basis for the alleged defaults is that Curis and Curis Royalty were required to disclose, and failed to disclose, certain information prior to execution of the Oberland Purchase Agreement and that Curis and Curis Royalty have since failed to disclose certain information that has been requested by the Purchasers pursuant to Section 6.04(b) of the Oberland Purchase Agreement. The letter further alleges that these alleged defaults are events of default under the Oberland Purchase Agreement and that each alleged default separately entitles the Purchasers to exercise the put option described above, which would require Curis Royalty to repurchase the Purchased Receivables at the Put/Call Price. The Purchasers have not attempted to exercise that put option but have purported to reserve their alleged right to exercise it without further notice. The Purchasers have also reserved other asserted rights in respect of the alleged defaults, including the asserted right to seek judicial remedies, including for damages and rescission, and to assert alleged claims against Curis and Curis Royalty for indemnification on the basis of material breach and fraud in the inducement. Curis and Curis Royalty dispute these allegations. If Oberland elects to pursue these claims, and if Curis and Curis Royalty are unsuccessful in defending against these claims, it could have a material adverse impact on Curis and Curis Royalty, including their ability to continue as a going concern. We have not received any further communication on this topic from counsel to Oberland Capital Management, LLC, or the Purchasers and the Agent since the March 2023 letter. As of December 31, 2023, the estimated amount of the Put/Call Price is $56.9 million.

(9)Common Stock

All common share amounts and per share amounts have been adjusted to reflect the Reverse Stock Split.

(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.

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

In March 2021, the Company entered into a sales agreement (the “2021 Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) and JonesTrading Institutional Services LLC (“JonesTrading”) to sell from time to time 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 2021 Sales Agreement, Cantor and JonesTrading could 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 (the "Securities Act").

Pursuant to the terms of the 2021 Sales Agreement, the aggregate compensation payable to each of Cantor and JonesTrading was 3% of the gross proceeds from sales of the common stock sold by Cantor or JonesTrading, as applicable. The Company sold 229,185 shares of common stock under the 2021 Sales Agreement during the year ended December 31, 2022, representing gross proceeds of $6.3 million.

On February 8, 2024, the Company entered into an amended and restated sales agreement with Cantor and JonesTrading (the “2024 Sales Agreement”), which supersedes the 2021 Sales Agreement. Pursuant to the 2024 Sales Agreement, the Company can sell from time to time shares of the Company’s 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.

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.

(c)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)Aspire Capital Fund, LLC

In February 2020, the Company entered into a common stock purchase agreement (the “Agreement”) for the sale of up to $30.0 million of the Company's common stock with Aspire Capital Fund, LLC ("Aspire Capital"). The Company did not sell shares of common stock under the Agreement during the year ended December 31, 2022. The Agreement expired in August 2022. The Company also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement, which also expired in August 2022.

(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, 2023.

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 $9.9 million and $10.3 million in royalty revenues under the Genentech collaboration during the years ended December 31, 2023 and 2022, respectively. Cost of royalties comprises payments to university licensors and was immaterial for the years ended December 31, 2023 and 2022.

The Company has accounts receivable from Genentech under this collaboration of $2.7 million and $3.0 million as of December 31, 2023 and 2022, 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 third and fourth licensed program.

In February 2020, the Company and Aurigene further amended their collaboration agreement. Under the terms of the amended agreement, Aurigene will fund and 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 turn, Aurigene has rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. The Company retains U.S., European Union, and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia at percentage rates ranging from the high single digits up to 10% subject to specified reductions.

As of December 31, 2023, the Company has exercised its option to license the following four programs under the collaboration:

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

  2. PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170.

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

  4. An immuno-oncology program.

For each of the licensed 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, and Aurigene is obligated to use commercially reasonable efforts to perform its obligations under the development plan for such licensed program in an expeditious manner.

For each of the IRAK4, PD1/VISTA, PD1/TIM3 programs, and the immuno-oncology program, 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.

(c)ImmuNext

In January 2020, the Company entered into an option and license agreement with ImmuNext (the “ImmuNext Agreement”). Under the terms of the ImmuNext Agreement, the Company agreed to engage in a collaborative effort with ImmuNext, and to conduct a Phase 1 clinical trial of CI-8993. In exchange, ImmuNext granted the Company an exclusive option, exercisable until the earlier of (a) January 2024 or (b) 90 days after database lock for the first Phase 1 trial in which the endpoints are satisfied to obtain an exclusive, worldwide license to develop and commercialize certain VISTA antagonizing compounds and products containing these compounds in the field of oncology. The Company did not exercise its option. The rights to the VISTA antagonizing compounds reverted to ImmuNext upon the expiration of the ImmuNext agreement in January 2024.

(11) Stock Plans and Stock-Based Compensation

As of December 31, 2023, the Company hadtwo shareholder-approved, stock-based compensation plans: (i) the Fourth 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 number of shares of common stock available for issuance under the plans and the number of shares of common stock issuable upon the exercise of then outstanding options have been adjusted to reflect the Reverse Stock Split.

The Fourth 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. The Company can issue up to 1,159,500 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, 2023, 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, 2023, the Company’s board of directors granted options to purchase 220,180 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, 2023, 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, 2023,289,912 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, 2023, the Company’s board of directors granted Inducement Awards to purchase 43,112 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, 2022683,666$64.726.51
Granted284,54213.90
Exercised(515)13.40
Canceled(126,813)64.58
Outstanding, December 31, 2023840,880$47.587.16$91
Exercisable at December 31, 2023450,008$63.005.77$—
Vested and unvested expected to vest at December 31, 2023840,880$47.587.16$91

The weighted average grant date fair values of stock options granted during the years ended December 31, 2023 and 2022 were $11.70 and $42.80, respectively, and were calculated usingthe following estimated assumptions under the Black-Scholes option pricing model:

For the Year EndedDecember 31,
20232022
Expected term (years)5.55.5
Risk-free interest rate3.5-4.7%1.4-4.1%
Expected volatility115-116%110-115%
Expected dividend yieldNoneNone

As of December 31, 2023, there was approximately $8.0 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 2.5 years. The intrinsic value of employee stock options exercised during the year ended December 31, 2023 was immaterial.

Restricted Stock Awards

The following table presents a summary of outstanding RSAs under the 2010 Plan as of December 31, 2023:

Number ofSharesWeightedAverageGrant Date Fair Value
Unvested, December 31, 2022—$—
Awarded117,00018.20
Vested——
Forfeited(6,500)18.20
Unvested, December 31, 2023110,500$18.20

As of December 31, 2023, there were 110,500 shares outstanding underlying RSAs that are expected to vest. The aggregate fair value of these shares of restricted stock was $2.1 million. As of December 31, 2023, there was $1.4 million of unrecognized compensation costs related to RSAs, which are expected to be recognized as expense over a remaining weighted average period of 1.4 years.

Amended and Restated 2010 Employee Stock Purchase Plan

The Company has reserved 100,000 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, 2023,32,117 shares were issued under the ESPP. As of December 31, 2023, there were 26,631 shares available for future purchase under the ESPP.

For the years ended December 31, 2023 and 2022, 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.

Total Stock-Based Compensation Expense

For the years ended December 31, 2023 and 2022, the Company recorded employee and non-employee 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,
20232022
Research and development expenses$2,770$2,798
General and administrative expenses3,2303,954
Total stock-based compensation expense$6,000$6,752

No income tax benefits have been recorded for the years ended December 31, 2023 and 2022, 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. For the years ended December 31, 2023 and 2022, the Company made matching contributions of $0.6 million and $0.7 million, respectively.

(13)Income Taxes

For the years ended December 31, 2023 and 2022, 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, 2023 and 2022 are as follows:

For the Year EndedDecember 31,
20232022
Statutory federal income tax rate21.0%21.0%
State income taxes, net of federal benefit6.1%6.0%
Research and development tax credits3.7%3.3%
Orphan drug tax credits4.9%4.4%
Expiration of NOLs/credits(6.3)%(3.2)%
Other1.5%(0.6)%
Stock based compensation(2.5)%—%
Change in valuation allowance(28.4)%(30.9)%
Effective income tax rate—%—%

The principal components of the Company’s deferred tax assets at December 31, 2023 and December 31, 2022, respectively, are as follows:

December 31,
20232022
Deferred Tax Assets:
NOL carryforwards$91,036$79,827
Research and development tax credit carryforwards16,97315,996
Orphan drug tax credit carryforwards24,98322,565
Depreciation and amortization5,5526,449
Capitalized research and development expenditures42,27141,168
Stock options4,8574,506
Accrued expenses and other9731,067
Oberland agreement11,64013,285
Lease liability7631,072
Total gross deferred tax asset199,048185,935
Valuation allowance(198,212)(184,738)
Net deferred tax asset$836$1,197
Deferred tax liabilities:
Right of use asset(836)(1,197)
Total gross deferred tax liabilities$(836)$(1,197)
Net deferred tax assets (liabilities)$—$—

As of December 31, 2023, the Company had U.S. federal tax-effected net operating loss carryforwards of $74.8 million, of which $34.1 million will expire in years 2024 through 2037 and the remainder do not expire but are subject to 80% limitation. As of December 31, 2023, the Company had state net operating loss carryforwards of $16.2 million that will expire between years 2033 and 2043.

As of December 31, 2023 and 2022, the Company had federal research and development credit carryforwards of $12.9 million and $12.2 million, respectively. The credits will expire in the years 2024 through 2043. As of December 31, 2023 and 2022, the Company had state research and development credit carryforwards of $4.1 million and $3.8 million, respectively. The credits will expire in the years 2024 through 2038, unless previously utilized.

As of December 31, 2023 and 2022, the Company had orphan drug tax credit carryforwards of $25.0 million and $22.6 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 2043.

As of December 31, 2023 and 2022, the Company had deferred tax assets associated with the capitalization of Section 174 costs of $16.9 million and $9.8 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 $198.2 million and $184.7 million as of December 31, 2023 and 2022, respectively. The valuation allowance increased approximately $13.5 million and $17.3 million during the years ended December 31, 2023 and 2022.

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, 2023 and 2022, 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, 2023, the Company is generally no longer subject to examination by taxing authorities for years prior to 2020. 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.

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