Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data.
COMPASS THERAPEUTICS, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page(s)
Report of Independent Registered Public Accounting Firm
116
Consolidated Financial Statements
Consolidated Balance Sheets
117
Consolidated Statements of Operations and Comprehensive Loss
118
Consolidated Statements of Changes in Stockholders ’ Equity
119
Consolidated Statements of Cash Flows
120
Notes to Consolidated Financial Statements
121
115
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Compass Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Compass Therapeutics, Inc. and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and 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 each of the two years in the period ended December 31, 2024 in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these 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 in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit 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 entity'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.
/s/ CohnReznick LLP
We have served as the Company’s auditor since March 2020.
Melville, New York
February 27, 2025
116
Compass Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except par value per share data)
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
43,483
$
24,228
Marketable securities
83,239
128,233
Prepaid expenses and other current assets
6,029
1,420
Total current assets
132,751
153,881
Property and equipment, net
353
898
Operating lease, right-of-use ("ROU") asset
6,731
1,776
Other assets
568
320
Total assets
$
140,403
$
156,875
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
2,249
$
4,090
Accrued expenses
6,287
2,514
Operating lease obligations, current portion
338
1,197
Total current liabilities
8,874
7,801
Operating lease obligations, net of current portion
6,296
536
Total liabilities
15,170
8,337
Commitments and Contingencies (Note 11)
Stockholders' equity:
Common stock, $ 0.0001 par value: 300,000 shares authorized; 137,820 shares issued and outstanding at December 31, 2024; 127,668 shares issued and outstanding at December 31, 2023
14
13
Additional paid-in-capital
489,692
463,796
Accumulated other comprehensive income
210
37
Accumulated deficit
( 364,683
)
( 315,308
)
Total stockholders' equity
125,233
148,538
Total liabilities and stockholders' equity
$
140,403
$
156,875
The accompanying notes are an integral part of these consolidated financial statements.
117
Compass Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
Year Ended December 31,
2024
2023
Licensing revenue
$
850
$
—
Operating expenses:
Research and development
42,342
38,120
General and administrative
15,133
12,243
Total operating expenses
57,475
50,363
Loss from operations
( 56,625
)
( 50,363
)
Other income
7,250
7,869
Net loss
$
( 49,375
)
$
( 42,494
)
Net loss per share - basic and diluted
$
( 0.36
)
$
( 0.33
)
Basic and diluted weighted average shares outstanding
137,384
127,027
Other comprehensive loss:
Net loss
$
( 49,375
)
$
( 42,494
)
Unrealized gain on marketable securities
173
339
Comprehensive loss
$
( 49,202
)
$
( 42,155
)
The accompanying notes are an integral part of these consolidated financial statements.
118
Compass Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Changes in Stockholders ’ Equity
(In thousands)
Common Stock
Additional
Paid-in
Accumulated Other
Comprehensive
Accumulated
Total
Stockholders'
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance at December 31, 2022
126,302
$
13
$
454,741
$
( 302
)
$
( 272,814
)
$
181,638
Common shares issued in ATM Offering, net
952
—
3,032
—
—
3,032
Common stock issued upon exercise of options
29
—
62
—
—
62
Share-based awards, net of tax remittance
385
—
( 159
)
—
—
( 159
)
Stock-based compensation
—
—
6,120
—
—
6,120
Unrealized gain on marketable securities
—
—
—
339
—
339
Net loss
—
—
—
—
( 42,494
)
( 42,494
)
Balance at December 31, 2023
127,668
$
13
$
463,796
$
37
$
( 315,308
)
$
148,538
Common shares issued, net of $ 0.5 million costs
9,790
$
1
$
17,568
$
—
$
—
$
17,569
Share-based awards, net of tax remittance
362
—
( 232
)
—
—
( 232
)
Stock-based compensation
—
—
8,560
—
—
8,560
Unrealized gain on marketable securities
—
—
—
173
—
173
Net loss
—
—
—
—
( 49,375
)
( 49,375
)
Balance at December 31, 2024
137,820
$
14
$
489,692
$
210
$
( 364,683
)
$
125,233
The accompanying notes are an integral part of these consolidated financial statements.
119
Compass Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Year Ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$
( 49,375
)
$
( 42,494
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
589
699
Share-based compensation
8,560
6,120
Amortization of premium and discount on marketable securities
( 1,651
)
( 3,226
)
ROU asset amortization
1,164
1,191
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 4,857
)
6,762
Accounts payable
( 1,841
)
708
Accrued expenses
3,773
( 9,176
)
Operating lease liability
( 1,217
)
( 1,202
)
Net cash used in operating activities
( 44,855
)
( 40,618
)
Cash flows from investing activities:
Purchases of marketable securities
( 88,158
)
( 155,418
)
Proceeds from sale or maturities of marketable securities
134,974
182,413
Purchases of property and equipment
( 44
)
( 30
)
Net cash provided by in investing activities
46,772
26,965
Cash flows from financing activities:
Proceeds from issuance of common stock
18,113
3,126
Issuance costs from issuance of common stock
( 543
)
( 94
)
Proceeds from exercise of stock options
—
62
Taxes related to the vesting of RSUs
( 232
)
( 159
)
Net cash provided by financing activities
17,338
2,935
Net change in cash and cash equivalents
19,255
( 10,718
)
Cash and cash equivalents at beginning of year
24,228
34,946
Cash and cash equivalents at end of year
$
43,483
$
24,228
Supplemental disclosure of cash flow information
Unrealized gain on marketable securities
$
( 173
)
$
( 339
)
The accompanying notes are an integral part of these consolidated financial statements.
120
Compass Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
1.
Formation and Business of the Company
Compass Therapeutics, Inc. (“Compass” or the “Company”) is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Our scientific focus is on the relationship between angiogenesis and the immune system. Our pipeline includes novel product candidates that leverage our understanding of the tumor microenvironment, including both angiogenesis-targeted agents and immune-oncology focused agents. These product candidates are designed to optimize critical components required for an effective anti-tumor response to cancer. These include modulation of the microvasculature via angiogenesis-targeted agents; induction of a potent immune response via activators on effector cells in the tumor microenvironment; and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with our proprietary drug candidates as long as their continued development is supported by clinical and nonclinical data. References to Compass or the Company herein include Compass Therapeutics, Inc. and its wholly-owned subsidiaries.
The Company is subject to risks and uncertainties common to companies in the biotechnology and pharmaceutical industries. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants.
2.
Liquidity, Uncertainties and Going Concern
The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.
Since its inception, the Company has funded its operations primarily with proceeds from the sale of its equity securities. The Company has incurred recurring losses since its inception and had an accumulated deficit of $ 365 million on December 31, 2024. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2027. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations.
The Company is subject to risks common to early stage companies in the biotechnology industry including, but not limited to: having a limited operating history and no products approved for commercial sale; having a history of significant losses; its need to obtain additional financing; dependence on its ability to advance its current and future product candidates through clinical trials, marketing approval and commercialization; the lengthy and expensive nature and uncertain outcomes of the clinical development process; the lengthy, time consuming and unpredictable nature of the regulatory approval process; the results of preclinical studies and early stage clinical trials that may not be predictive of future results; dependence on its key personnel; risks related to patent protection and the Company’s pending patent applications; dependence on third party collaborators for the discovery, development and commercialization of current and future product candidates; and significant competition from other biotechnology and pharmaceutical companies. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
121
3.
Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements are presented in U.S. dollars and have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Compass Therapeutics, Inc., and its wholly-owned subsidiaries, including Compass Therapeutics LLC, Compass Therapeutics Advisors Inc., Trigr Therapeutics, Inc. and Compass Therapeutics Securities Corporation. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual of research and development expenses, useful lives of equipment, interest rate and term operating lease ROU and liability, the percentage of completion of contractual arrangements, future cash expenditures for liquidity estimates, the valuation of common stock and estimates associated with stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Changes in estimates are recorded prospectively in the period that they become known.
Segment Information
Operating segments are defined as components of an enterprise for which separate and discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company has one operating segment. The Company’s chief operating decision-maker, its chief executive officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
Cash and Cash Equivalents
The Company considers all highly liquid investments that are readily convertible into cash with original maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held in money market funds or commercial paper. Cash equivalents are stated at cost, which approximates market value. Cash and cash equivalents were $ 43.5 million and $ 24.2 million on December 31, 2024 and 2023, respectively.
122
Marketable Securities
All of the Company’s investment securities are debt securities and bank instruments. The Company carries these investments at fair value. Unrealized gains and losses, if any, are reported as a separate component of stockholders’ equity. The cost of investment securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses, if any, are also included in interest income. The cost of securities sold is based on the specific identification method.
Concentrations of Credit Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash equivalents and marketable securities. The Company invests its excess cash primarily in money market funds, U.S. treasury notes, and high quality, marketable debt instruments of corporations in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. The Company has not experienced any realized losses related to its cash equivalents and marketable securities.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the related assets as follows:
Asset Classification
Estimated Useful Life
Equipment
5 years
Furniture and fixtures
7 years
Software
5 years
Leasehold improvements
Lesser of estimated useful life or lease term
Estimated useful lives are periodically assessed to determine if changes are appropriate. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost of these assets and related accumulated depreciation or amortization are eliminated from the consolidated balance sheet and any resulting gains or losses are included in the consolidated statement of operations and comprehensive loss in the period of disposal. Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service.
Impairment of Long-Lived Assets
Long-lived assets consist of property, equipment and right-of-use (“ROU”) assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in the consolidated statements of operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. The Company did not record any impairment losses on long-lived assets during the years ended December 31, 2024 and 2023.
123
Fair Value Measurements
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
●
Level 1 – Quoted prices in active markets for identical assets or liabilities.
●
Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets and liabilities, or other inputs that are observable or can be corroborated by observable market data.
●
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
An entity may choose to measure many financial instruments and certain other items at fair value at specified election dates. Subsequent unrealized gains and losses on items for which the fair value option has been elected are reported in earnings.
Research and Development Costs
Costs associated with internal research and development and external research and development services, including drug development and preclinical studies, are expensed as incurred. Research and development expenses include costs for salaries, employee benefits, subcontractors, facility-related expenses, depreciation and amortization, stock-based compensation, third-party license fees, laboratory supplies, and external costs of outside vendors engaged to conduct discovery, preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials and other costs. The Company recognizes external research and development costs based on an evaluation of the progress of specific tasks using information provided to the Company by its service providers.
Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such prepaid expenses are recognized as an expense when the goods have been delivered or the related services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
124
Costs associated with licenses of technology acquired as part of collaborative arrangements are expensed as incurred and are generally included in research and development expense in the consolidated statements of operations if it is determined the license has no alternative future use.
Accrued Research and Development Expenses
The Company has entered into various research and development and other agreements with commercial firms, researchers, universities and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made to determine the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expense in the consolidated statements of operations.
Stock-Based Compensation
The Company recognizes the grant‑date fair value of stock‑based awards issued to employees and nonemployee board members as compensation expense on a straight‑line basis over the service period of the award. The Company uses the Black‑Scholes option pricing model to determine the grant‑date fair value of stock options and adjusts expense for forfeitures in the periods they occur.
The fair value of each equity award was determined by the Company on the date of grant and by using the methods and assumptions discussed below. Certain of these inputs are subjective and generally require judgment to determine.
Stock price: The stock price used to value equity awards is based on the closing price of the Company’s common stock as reported on the date of the grant. For equity awards issued after June 2020 until the Company started trading on a public market in the second quarter of 2021, the valuation of the Company’s common stock was $ 5.00 per share, which was the share price paid by outside investors in the Company’s Private Placement in June 2020.
Expected term : The expected term of the equity award represents the weighted average period the award is expected to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the Securities and Exchange Commission. The simplified method calculates the expected term as the average time to vesting and the contractual life of the award.
Expected volatility – The expected volatility is calculated based on the historical volatility of our common stock over the expected term of the option.
Risk-free interest rate – The risk-free rate assumption is based on U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s equity award.
Expected dividend – The Company has not paid and does not intend to pay dividends.
125
Net Loss per Share
Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, stock options, restricted stock units, unvested restricted stock awards and common stock warrants that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities outstanding as of December 31, 2024 and 2023 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:
December 31,
2024
2023
(000's)
Restricted stock units
3,766
1,500
Stock options
14,062
7,876
Total
17,828
9,376
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the deferred tax benefits will not be realized.
The Company files income tax returns in the U.S. Federal jurisdiction and in various states. The Company has tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination.
New Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2024-09, Income Taxes (Topic 740) : Improvements to Tax Disclosures . The purpose of ASU 2024-09 is to enhance the transparency and decision usefulness of income tax disclosures. The ASU requires a significant expansion of the granularity of the income tax rate reconciliation as well as an expansion of other income tax disclosures. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. This will result in additional disclosures being included in our consolidated financial statements, once adopted. The Company is evaluating the impact of ASU 2024-09 and does not expect ASU-2024-09 to have a significant impact on the consolidated financial statements.
126
Recently Adopted Accounting Pronouncements
The Company adopted ASU No. 2023-07, Segment Reporting — Improvements to Reportable Segment Disclosures (Topic 280) as of January 1, 2024. The amendments in ASU 2023-07 improve financial reporting by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors to develop more decision-useful financial analyses. ASU 2023-07 requires a public entity to report a measure of segment profit or loss that the chief operating decision maker (CODM) uses to assess segment performance and make decisions about allocating resources. ASU 2023-07 also requires other specified segment items and amounts, such as depreciation, amortization, and depletion expense, to be disclosed under certain circumstances. The amendments in ASU 2023-07 do not change or remove those disclosure requirements. The amendments in ASU 2023-07 also do not change how a public entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, adopted retrospectively. The adoption of ASU 2023-07 did not have a material effect on the Company’s consolidated financial statements or disclosures.
There are no other pending accounting pronouncements that are expected to have a material impact on the Company’s consolidated financial statements.
127
4.
Fair Value Measurements
The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:
Fair Value Measurements as of December 31, 2024 (000's):
Quoted Prices
Significant
in Active
Other
Significant
Markets for
Observable
Unobservable
Identical Assets
Inputs
Inputs
(Level 1)
(Level 2)
(Level 3)
Fair Value
Assets
Corporate bonds
$
—
$
44,963
$
—
$
44,963
Certificates of deposit
—
15,269
—
15,269
Commercial paper
12,084
—
—
12,084
U.S. government treasuries
4,399
—
—
4,399
Asset-backed securities
—
6,524
—
6,524
Money market funds (cash equivalents)
23,880
—
—
23,880
Total assets
$
40,363
$
66,756
$
—
$
107,119
Fair Value Measurements as of December 31, 2023 (000's):
Quoted Prices
Significant
in Active
Other
Significant
Markets for
Observable
Unobservable
Identical Assets
Inputs
Inputs
(Level 1)
(Level 2)
(Level 3)
Fair Value
Assets
Corporate bonds
$
—
$
54,281
$
—
$
54,281
Certificates of deposit
—
18,866
—
18,866
Commercial paper
28,534
—
—
28,534
U.S. government treasuries
16,080
—
16,080
Asset-backed securities
—
10,472
—
10,472
Money market funds (cash equivalents)
575
—
—
575
Total assets
$
45,189
$
83,619
$
—
$
128,808
5.
Marketable Securities
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any net losses from its investments.
Unrealized gains and losses on investments that are available for sale are recognized in accumulated comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis. The Company classifies marketable securities that are available for use in current operations as current assets on the consolidated balance sheet.
128
The following tables summarize marketable securities held at December 31, 2024 and 2023 (in thousands):
Fair Value Measurements as of December 31, 2024 Using:
Amortized Cost
Unrealized gains
Unrealized Losses
Fair Value
Assets
Corporate bonds
$
44,794
$
175
$
( 6
)
$
44,963
Certificates of deposit
15,262
8
( 1
)
15,269
Commercial paper
12,081
5
( 2
)
12,084
Asset-backed securities
6,484
40
—
6,524
U.S. government treasuries
4,408
2
( 11
)
4,399
Total assets
$
83,029
$
230
$
( 20
)
$
83,239
Fair Value Measurements as of December 31, 2023 Using:
Amortized Cost
Unrealized gains
Unrealized Losses
Fair Value
Assets
Corporate bonds
$
54,256
$
74
$
( 49
)
$
54,281
Certificates of deposit
18,850
17
( 1
)
18,866
Commercial paper
28,507
30
( 3
)
28,534
Asset-backed securities
10,456
23
( 7
)
10,472
U.S. government treasuries
16,127
3
( 50
)
16,080
Total assets
$
128,196
$
147
$
( 110
)
$
128,233
As of December 31,
2024
2023
Maturing in one year or less
56,386
93,117
Maturing after one year through two years
26,853
35,116
Total
$
83,239
$
128,233
129
6.
Property and Equipment
Property and equipment consist of the following:
December 31,
2024
2023
(000's)
Equipment
$
4,716
$
5,167
Furniture and fixtures
22
22
Leasehold improvements
1,612
1,612
Software
364
364
Total property and equipment–at cost
6,714
7,165
Less: Accumulated depreciation and amortization
( 6,361
)
( 6,267
)
Property and equipment, net
$
353
$
898
Total depreciation and amortization expense for years ended December 31, 2024 and 2023, was $ 0.6 million and $ 0.7 million, respectively.
7.
Accrued Expenses
Accrued expenses consist of the following:
December 31,
2024
2023
(000's)
Project expenses
$
2,873
$
336
Compensation and benefits
2,793
1,938
Other
621
240
Total accrued expenses
$
6,287
$
2,514
Project expenses in 2024 were primarily made up of $ 2.6 million of accrued manufacturing expenses related to minimum contractual obligations. Compensation and benefits primarily increased from 2023 based on accrued payroll related to the departure of the CEO of $ 0.7 million.
8.
Stockholders ’ Equity
In the first quarter of 2024, the Company sold through its at-the-market (“ATM”) agreement with Jefferies LLC, 9,790,577 shares of common stock at an average price of $ 1.85 for total proceeds of $ 18.1 million and net proceeds of $ 17.6 million.
In the second quarter of 2023, the Company sold through its ATM agreement with Jefferies LLC, 951,873 shares of common stock at an average price of $ 3.28 for total proceeds of $ 3.1 million and net proceeds of $ 3.0 million.
130
9.
Stock-Based Compensation
Stock-based compensation expense for the years ended December 31, 2024 and 2023 was classified in the consolidated statements of operations as follows:
Year Ended
December 31,
2024
2023
(000's)
Research and development
$
2,971
$
1,998
General and administrative
5,589
4,122
Total
$
8,560
$
6,120
2020 Plan
In June 2020, the Company’s board of directors adopted the 2020 Plan and reserved 2.9 million shares of common stock for issuance under this plan. The 2020 Plan provides that the number of shares reserved and available for issuance under the 2020 Plan will automatically increase each January 1, beginning on January 1, 2021, by the lesser of 4% of the outstanding number of shares of our common stock on the immediately preceding December 31 or such number of shares as determined by the plan administrator no later than the immediately preceding December 31. As of December 31, 2024, 1.4 million shares remain available for future grant. On January 1, 2025, an additional 5.5 million shares became available for issuance based on 4% of the outstanding shares of common stock, for a total of 6.9 million shares available for issuance.
The 2020 Plan authorizes the board of directors or a committee of the board to grant incentive stock options, nonqualified stock options, restricted stock awards and restricted stock units ("RSUs") to eligible officers, employees, consultants and directors of the Company. Options generally vest over a period of four years and have a contractual life of ten years from the date of grant.
Stock Options:
The following table summarizes the stock option activity for the 2020 Plan:
Number of
Nonvested
Options (000's)
Weighted
Average
Exercise
Price
Per Share
Weighted
Average
Remaining
Contractual
Life (in years)
Aggregate Intrinsic Value (000's)
Outstanding at December 31, 2022
5,378
$
3.89
8.24
$
6,316
Granted
2,803
$
3.69
9.18
$
—
Exercised
( 29
)
$
1.75
—
$
35
Forfeited/cancelled
( 276
)
$
4.29
—
$
164
Outstanding at December 31, 2023
7,876
$
3.81
8.05
$
11
Granted
6,193
$
1.58
7.10
$
—
Exercised
—
$
—
—
$
—
Forfeited/cancelled
( 7
)
$
3.04
—
$
—
Outstanding at December 31, 2024
14,062
$
2.83
6.23
$
579
Vested at December 31, 2024
6,551
$
3.67
5.28
$
49
For the year ended December 31, 2024, the weighted average grant date fair value for options granted was $ 1.13 . The aggregate intrinsic value for options vested and outstanding as of December 31, 2024 and 2023 was $ 579 thousand and $ 11 thousand, respectively. As of December 31, 2024, the unrecognized compensation cost related to outstanding options was $ 11.1 million, expected to be recognized over a weighted average period of approximately 1.5 years.
131
The weighted average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted to employees and directors during the years ended December 31, 2024 and 2023 were as follows:
Year Ended December 31,
2024
2023
Expected term (in years)
6.0
6.0
Risk-free rate
3.92
%
3.83
%
Expected volatility
81
%
87
%
RSUs:
The following table summarizes the RSU activity for the 2020 Plan:
Shares (000's)
Weighted
Average Price
Per Share
Weighted
Average Fair Value (000's)
Unvested, December 31, 2022
900
$
3.83
$
3,447
Granted
900
3.93
3,537
Vested
( 300
)
3.83
( 1,149
)
Forfeited or canceled
—
—
—
Unvested, December 31, 2023
1,500
$
3.83
$
5,745
Granted
2,791
$
1.89
$
5,275
Vested
( 525
)
3.87
( 2,032
)
Forfeited or canceled
—
—
—
Unvested, December 31, 2024
3,766
$
2.41
$
9,076
Weighted average price per share is the weighted grant price based on the closing market price of each of the stock grants. The weighted average fair value is the weighted average share price times the number of shares.
As of December 31, 2024, remaining unrecognized compensation cost related to RSUs to be recognized in future periods totaled $ 7.0 million, which is expected to be recognized over a weighted average period of 1.5 years. As of December 31, 2024, the total unrecognized compensation cost from all plans to be recognized in future periods totaled approximately $ 18.1 million.
10.
License, Research and Collaboration Agreements
Collaboration Agreements
ABL Bio Corporation ("ABL Bio") Agreements
In November 2018, the Company and ABL Bio, a South Korean biotechnology company, entered into an exclusive global (excluding South Korea) license agreement which granted the Company a license to tovecimig (ABL001), ABL Bio’s bispecific antibody targeting DLL4 and VEGF-A. Under the terms of the agreement, the two companies would jointly develop tovecimig, with ABL Bio responsible for development of tovecimig throughout the end of Phase 1 clinical trials and the Company responsible for the development of tovecimig from Phase 2 and onward. ABL Bio received a $ 5 million upfront payment and $ 6 million development milestone payment. In addition, ABL Bio is eligible to receive up to $ 96 million of development and regulatory milestone payments, and up to $ 303 million of commercial milestone payments and tiered single-digit royalties on net sales of tovecimig in oncology. ABL Bio is also eligible to receive up to $ 75 million in development and regulatory milestones and up to $ 110 million in commercial milestone payments and tiered, single-digit royalties on net sales of tovecimig in ophthalmology.
132
In May 2021, TRIGR and ABL Bio terminated license agreements to several preclinical assets. As a result of the return of these assets to ABL Bio and termination of the license agreements, the Company is eligible to receive royalty payments if ABL Bio develops or licenses two bispecific antibodies that were previously licensed to TRIGR.
Adimab Agreement
The Company entered into a collaboration agreement with Adimab, LLC on October 16, 2014. The agreement includes provisions for payment of royalties at rates ranging in the single digits as a percentage of future net sales within a specified term from the first commercial sale for certain antibodies, including our product candidate, CTX-471. There were no milestone payments made during 2024. As of December 31, 2024, future potential milestone payments in connection with this agreement amounted to $ 2.0 million.
11.
Commitments and Contingencies
Leases
The Company accounts for operating leases on a straight-line basis over the lease term, with recognition of a right-of-use asset and a corresponding lease liability, initially measured at the present value of the lease payments. For leases with a term of 12 months or less, we recognize lease expense on a straight-line basis over the lease term.
The Company has evaluated its leases under ASC 842, Leases , and determined that it has one lease that is classified as an operating lease. The classification of this lease is consistent with the Company’s determination under the previous accounting standard.
When available, the Company will use the rate implicit in the lease to discount lease payments to present value; however, the Company’s current lease does not provide an implicit rate. Therefore, the Company used its incremental borrowing rate of 6.25 % to discount the lease payments based on the date of the lease commencement.
The Company has one operating lease for its corporate office and laboratory facility (“Facility”) that was signed in December 2020. The Company moved into the Facility in January 2021. The Facility lease has an initial term of four years and five months, beginning on January 1, 2021.
The terms of the Facility lease were modified effective September 27, 2024 through the execution of a new lease. The modified terms extended the non-cancelable lease term through May 2031. The modified terms also included the right to use an additional 10,724 square feet that is expected to commence and be available for the Company’s use in May 2025. The classification and incremental borrowing rate for the lease did not change as a result of this lease modification. Right-of-use assets obtained in exchange for new operating lease liabilities due to the lease modification were $ 6.1 million for a total right-of-use assets as of December 31, 2024 of $ 6.7 million. The remaining lease term of the Facility lease is 6.4 years as of December 31, 2024. The Company has $ 568 thousand of restricted cash associated with an irrevocable letter of credit required by the landlord to enter into this lease.
133
Lease costs related to the Facility were $ 1.1 million and $ 1.3 million for the years ending December 31, 2024 and 2023, respectively. Cash paid for this lease was $ 1.4 million and $ 1.3 million for the years ended December 31, 2024 and 2023, respectively.
The table below presents the undiscounted cash flows for the lease term. The undiscounted cash flows are reconciled to the operating lease liabilities recorded on the consolidated balance sheets:
(000's)
Years ending December 31,
2025
$
733
2026
1,018
2027
1,412
2028
1,441
Thereafter
3,614
Total minimum lease payments
8,218
Less: amount of lease payments representing interest
( 1,584
)
Present value of future minimum lease payments
6,634
Less: operating lease obligations, current portion
( 338
)
Operating lease obligations, long-term portion
$
6,296
Defined Contribution Plan
The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for substantially all its employees. Eligible employees may make pre-tax or post-tax (Roth) contributions to the 401(k) Plan up to statutory limits. Since January 1, 2020, the Company has been matching employee contributions to the plan up to 4 % of salary. On July 1, 2023, the Company increased the employee matching contribution from 4 % to 6 %. The Company made matching contributions of $ 0.3 million and $0.2 million for the years ended December 31, 2024 and 2023, respectively.
12.
Other income
Other income consisted of interest income from investments on marketable securities of $ 7.3 million and $ 7.9 million for the years ended December 31, 2024 and 2023, respectively.
13.
Income Taxes
The Company had no income tax for the years ended December 31, 2024 and 2023.
The effective tax rate of our provision for income taxes differs from the federal statutory rate for the periods presented as follows:
December 31,
2024
2023
Statutory rate
21.0
%
21.0
%
State taxes
7.0
%
7.9
%
Share-based compensation & other nondeductible expenses
- 1.1
%
1.5
%
Research credits
5.8
%
7.3
%
Other
- 0.7
%
- 0.6
%
Change in valuation allowance
- 32.0
%
- 37.1
%
Total
0.0
%
0.0
%
134
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. In determining the need for a valuation allowance, management reviews both positive and negative evidence, including current and historical results of operations, future income projections and the overall prospects of our business. Based upon management’s assessment of all available evidence, the Company believes that it is more-likely-than-not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $ 59.5 million and $ 43.8 million as of December 31, 2024 and 2023, respectively.
As of December 31, 2024, the Company has U.S. federal and state net operating loss carryforwards (“NOLs”) of $ 79.8 . million and $ 80.0 million, respectively. As of December 31, 2024, the Company has federal and state research and development credit carryforwards (“R&D credits”) of $ 7.3 million and $ 2.4 million, respectively. For income tax purposes, federal NOLs will not expire since they were generated after 2017 and federal R&D credits will begin expiring in 2039. For income tax purposes, state NOLs and state R&D credits will begin to expire in 2040 and 2031, respectively.
Net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service (the “IRS”) and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50% as defined under Sections 382 and 383 in the Internal Revenue Code, which could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the Company’s value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has not yet conducted a study to determine if any such limitation exists.
The Tax Cuts and Jobs Act of 2017 (“TCJA”) amended IRC Section 174 to require capitalization of all research and developmental (R&D) costs incurred in tax years beginning after December 31, 2021. These costs are required to be amortized with a half-year convention over five years if the R&D activities are performed in the U.S., or over 15 years if the activities were performed outside the U.S. The Company capitalized approximately $ 39.9 million and amortized $ 14.3 million of R&D expenses incurred for the year ended December 31, 2024.
As of December 31, 2024 and 2023, the Company had no uncertain tax positions, and as such, no related interest or penalties have been recorded in the statements of operations and comprehensive loss. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. All tax years of the Company from inception are open to examination by federal tax and state tax authorities. To the extent utilized in future years’ tax returns, net operating loss carryforwards at December 31, 2024 will remain subject to examination until the respective tax year is closed. The Company has not been informed by any tax authorities for any jurisdiction that any of its tax years is under examination as of December 31, 2024.
135
Significant components of the Company’s deferred tax assets and liabilities are as follows:
December 31,
2024
2023
Deferred tax assets
(000's)
Federal net operating loss carryforwards
$
16,775
$
13,760
State net operating loss carryforwards
5,063
3,719
Research and development credits
9,252
6,387
Section 174 Capitalization
22,724
15,525
Share-based compensation
3,922
2,701
Lease liabilities
1,812
474
Capitalized licensing fees
1,375
1,484
Other
494
234
Subtotal
61,417
44,284
Less valuation allowance
( 59,521
)
( 43,799
)
Deferred tax assets, net of valuation allowance
1,896
485
Deferred tax liabilities
Right-of-use assets
( 1,839
)
( 485
)
Other
( 57
)
—
Net deferred tax assets
$
—
$
—
14.
Segment Information
Segment reporting is prepared on the same basis that our chief executive officer, who is our CODM, manages the business, makes operating decisions and assesses performance. The Company operates in one segment. The Company’s business is research and development of drug candidates. Costs, including supplies, outsourced development, personnel costs and other research and development costs are tracked to reported by major program. Facility and equipment costs are not allocated to programs. Research and development expenses are summarized by program in the table below:
Year Ended December 31,
2024
2023
(000's)
Licensing revenue
$
850
$
—
Personnel
9,918
7,568
General
3,965
3,647
Tovecimig
23,177
21,824
CTX-471
2,879
2,846
CTX-8371
2,403
2,235
Research and development
42,342
38,120
Personnel
3,818
2,623
General
4,661
4,054
Stock-based compensation
6,654
5,566
General and administrative
15,133
12,243
Other income
7,250
7,869
Net loss
$
( 49,375
)
$
( 42,494
)
136
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
Not applicable.