ALX ONCOLOGY HOLDINGS INC
For the period ended Mar 31, 2025. Filed May 8, 2025.
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Mar 31, 2025 · Filed May 8, 2025
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Notes to Condensed Consolidated Financial Statements
(1) ORGANIZATION
Organization
ALX Oncology Holdings Inc., or the Company, was formed as a Delaware corporation on April 1, 2020, or Inception. The Company was formed for the purpose of completing the Company’s initial public offering of its common stock and related transactions in order to carry on the business of ALX Oncology Limited. The Company is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system.
ALX Oncology Holdings Inc. is incorporated in Delaware. ALX Oncology Limited, incorporated in Ireland, is a wholly-owned subsidiary of ALX Oncology Holdings Inc. ALX Oncology Inc., incorporated in Delaware, is a wholly-owned subsidiary of ALX Oncology Limited. All the companies, except for ALX Oncology Holdings Inc., are collectively known as the Subsidiaries.
As of March 31, 2025, the Company has devoted substantially all of its efforts to the formation and financing of the Company, as well as product development, and has not realized product revenues from its planned principal operations. The Company does not have manufacturing facilities and all manufacturing related activities are contracted out to third-party service providers.
Management expects to incur additional losses in the future to conduct product candidate research and development and to conduct pre-commercialization activities and recognizes that the Company will likely be required to raise additional capital to fully implement its business plan. The Company intends to raise such capital through the sale of additional equity, debt financings and/or strategic alliances with third parties. However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms acceptable to the Company. If the Company is unsuccessful in its efforts to raise additional financing, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate some of its development programs or its future commercialization efforts, out-license intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above, any of which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all. The Company believes that the existing capital resources will be sufficient to fund the projected operating requirements for at least the next twelve months.
(2) SIGNIFICANT ACCOUNTING POLICIES
Basis of Preparation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 6, 2025.
The condensed consolidated balance sheet as of March 31, 2025 included herein was derived from the audited financial statements as of that date, but does not include all disclosures including notes required by U.S. GAAP.
The accompanying condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year ending December 31, 2025.
Principles of Consolidation
All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. On an ongoing basis, management evaluates its estimates, including, but not limited to, those related to the estimated useful lives of long-lived assets, clinical and contract manufacturing accruals, fair value of assets and liabilities, fair value of investments, and stock-based compensation. The Company evaluates its estimates and assumptions on an ongoing basis based on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
Significant Accounting Policies
There have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 requires enhanced annual disclosures regarding the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 and may be adopted on a prospective or retrospective basis. Early adoption is permitted. The Company is evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement Reporting - Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03). ASU 2024-03 requires disaggregated disclosure of certain costs and expenses, including purchases of inventory, employee compensation, depreciation and amortization, within relevant income statement captions. ASU 2024-03 is effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The guidance is applied on a prospective basis with the option for retrospective application. The Company is evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
(3) SEGMENT REPORTING
The Company manages its operations as asingle operating segment. The Company’s chief operating decision maker (CODM) uses consolidated, single-segment financial information for the purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
The CODM assesses performance and decides how to allocate resources based on the Company’s consolidated net loss, including key components of research and development costs and general and administrative costs. These measures are used to monitor budget versus actual results and to evaluate the performance of the segment.
The CODM reviews cash, cash equivalents and investments as a measure of segment assets. As of March 31, 2025 and December 31, 2024, the Company’s cash, cash equivalents and investments were$107.0 million and$131.3 million, respectively.
The following table presents the significant segment expenses for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Research and development expenses: | ||
| Clinical and development costs | $10,537 | $17,537 |
| Preclinical costs | 1,238 | 819 |
| Personnel and related costs | 7,563 | 5,896 |
| Stock-based compensation expense | 3,005 | 4,998 |
| Other research costs | 1,545 | 2,467 |
| Total research and development expenses | 23,888 | 31,717 |
| General and administrative expenses: | ||
| Personnel and related costs | 2,825 | 1,612 |
| Stock-based compensation expense | 2,211 | 2,033 |
| Other general and administrative costs | 2,896 | 2,400 |
| Total general and administrative expenses | 7,932 | 6,045 |
| Loss from operations | (31,820) | (37,762) |
| Interest income | 1,483 | 2,622 |
| Interest expense | (406) | (427) |
| Other income (expense), net | (11) | (14) |
| Net loss | $(30,754) | $(35,581) |
(4)FAIR VALUE OF FINANCIAL INSTRUMENTS
The fair value of the Company’s financial assets and liabilities are determined in accordance with the fair value hierarchy established in ASC 820, Fair Value Measurements and Disclosures.
The following table presents the Company’s investments, which consist of cash equivalents and investments classified as available-for-sale investments, that are measured at fair value on a recurring basis by level within the fair value hierarchy as of March 31, 2025 and December 31, 2024 (in thousands):
| Fair ValueHierarchyLevel | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents | |||||
| Money market funds | Level 1 | $17,550 | $— | $— | $17,550 |
| Corporate debt securities | Level 2 | 1,393 | 2 | — | 1,395 |
| Short-term investments | |||||
| U.S. Treasury securities | Level 1 | 34,821 | 73 | — | 34,894 |
| Corporate debt securities | Level 2 | 41,063 | 42 | — | 41,105 |
| Commercial paper | Level 2 | 1,219 | — | (1) | 1,218 |
| Long-term investments | |||||
| U.S. government agency securities | Level 2 | 2,000 | 1 | — | 2,001 |
| Corporate debt securities | Level 2 | 7,159 | 1 | — | 7,160 |
| Total | $105,205 | $119 | $(1) | $105,323 | |
| Fair ValueHierarchyLevel | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|---|
| Cash equivalents | |||||
| Money market funds | Level 1 | $15,468 | $— | $— | $15,468 |
| Short-term investments | |||||
| U.S. Treasury securities | Level 1 | 52,167 | 148 | — | 52,315 |
| U.S. government agency securities | Level 2 | 3,101 | 6 | — | 3,107 |
| Corporate debt securities | Level 2 | 52,657 | 122 | — | 52,779 |
| Commercial paper | Level 2 | 1,988 | 1 | — | 1,989 |
| Long-term investments | |||||
| Corporate debt securities | Level 2 | 3,526 | 1 | (3) | 3,524 |
| Total | $128,907 | $278 | $(3) | $129,182 | |
The fair value of cash equivalents and available-for-sale investments by classification included in the condensed consolidated balance sheets was as follows as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Cash equivalents | $18,945 | $15,468 |
| Short-term investments | 77,217 | 110,190 |
| Long-term investments | 9,161 | 3,524 |
| Total | $105,323 | $129,182 |
Cash and cash equivalents in the above table excludes bank account cash of$1.7 million and$2.1 million as of March 31, 2025 and December 31, 2024, respectively.
The fair value of cash equivalents and available-for-sale investments by contractual maturity was as follows as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Maturing in one year or less | $96,162 | $125,658 |
| Maturing after one year through five years | 9,161 | 3,524 |
| Total | $105,323 | $129,182 |
The primary objective of the Company’s investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. The Company’s investment policy limits investments to certain types of instruments issued by institutions with investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
There wereno transfers of financial instruments between the fair value measurement levels during thethree months ended March 31, 2025 and 2024 and there wereno financial instruments classified as Level 3 as of March 31, 2025 and December 31, 2024.
As of March 31, 2025 and December 31, 2024, accrued interest receivable related to the Company’s investments of$0.9 million was included inprepaid expenses and other current assets on the condensed consolidated balance sheet.
As of March 31, 2025, the unrealized losses for available-for-sale investments were non-credit related and the Company does not intend to sell the investments that were in an unrealized loss position, nor does it foresee or project that it will be required to sell those investments before recovery of their amortized costs basis, which may be maturity. As of March 31, 2025 and 2024, no allowance for credit losses for the Company’s investments was recorded. As of March 31, 2025 and December 31, 2024, no securities were in a continuous net unrealized loss position for more than 12 months. As of March 31, 2025 and 2024, the Company hasnot recognized any impairment losses on available-for-sale investments.
(5)BALANCE SHEET COMPONENTS
Prepaid Expenses and Other Current Assets
The following table presents the components of prepaid expenses and other current assets as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Prepaid clinical expenses | $2,643 | $3,757 |
| Interest and investment receivables | 911 | 892 |
| Prepaid expenses | 834 | 1,343 |
| Prepaid insurance | 313 | 576 |
| Other current assets | — | 27 |
| Total prepaid expenses and other current assets | $4,701 | $6,595 |
Property and Equipment, Net
The following table presents the components of property and equipment, net as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Leasehold improvements | $2,509 | $2,509 |
| Laboratory equipment | 1,844 | 1,835 |
| Computer hardware and software | 473 | 473 |
| Furniture and fixtures | 165 | 165 |
| Property and equipment, gross | 4,991 | 4,982 |
| Less: accumulated depreciation | (2,288) | (2,077) |
| Property and equipment, net | $2,703 | $2,905 |
Depreciation was$0.2 million for the three months ended March 31, 2025 and 2024.
Other Assets
The following table presents the components of other assets as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Operating lease right-of-use assets | $3,807 | $4,023 |
| Finance lease right-of-use assets | 2,442 | 2,704 |
| Other assets | 200 | 200 |
| Long-term prepaid contract manufacturing costs | 55 | 67 |
| Total other assets | $6,504 | $6,994 |
Accrued Expenses and Other Current Liabilities
The following table presents the components of accrued expenses and other current liabilities as of March 31, 2025 and December 31, 2024 (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Accrued clinical and nonclinical study costs | $5,500 | $3,858 |
| Accrued compensation and related expenses | 3,763 | 5,306 |
| Other current liabilities | 2,621 | 2,573 |
| Accrued contract manufacturing | 939 | 1,479 |
| Accrued property and equipment | 195 | 203 |
| Total accrued expenses and other current liabilities | $13,018 | $13,419 |
(6)LEASES
The Company has non-cancelable operating leases for its offices located in the U.S. As of March 31, 2025, these leases expire on various dates between 2026 and 2030. Certain lease agreements include one or more options to renew, with renewal terms that can extend the lease up totwo years after expiration. The Company has the right to exercise or forego the lease renewal options. The lease agreements do not contain any material residual value guarantees or material restrictive covenants.
The following table presents the maturities and balance sheet information of the Company’s operating lease liabilities as of March 31, 2025 (in thousands, except lease term and discount rate):
| Operating Leases · Finance Leases | ||
|---|---|---|
| 2025 | $983 | $864 |
| 2026 | 1,187 | 1,152 |
| 2027 | 912 | 672 |
| 2028 | 939 | — |
| 2029 | 967 | — |
| Thereafter | 163 | — |
| Total lease payments | 5,151 | 2,688 |
| Less: imputed interest | (967) | (258) |
| Total lease liabilities | $4,184 | $2,430 |
| Lease liabilities: current (i) | $976 | $983 |
| Lease liabilities: non-current (ii) | 3,208 | 1,447 |
| Total lease liabilities | $4,184 | $2,430 |
| Weighted average remaining lease term (in years) | 4.4 | 2.3 |
| Weighted average discount rate | 9.1% | 8.5% |
(i)
Current lease liabilities are presented within accrued expenses and other current liabilities on the condensed consolidated balance sheets.
(ii)
Non-current lease liabilities are presented within other non-current liabilities on the condensed consolidated balance sheets.
The following table presents the components of lease costs for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Operating lease cost | $292 | $311 |
| Variable lease cost and other, net (i) | 112 | 167 |
| Short-term lease cost | — | 8 |
| Finance lease cost: | ||
| Amortization of right-of-use assets | 262 | 249 |
| Interest | 55 | 47 |
| Total lease costs | $721 | $782 |
(i)
The variable lease cost and other, net is comprised primarily of common area maintenance charges for the operating lease, which are dependent on usage. These costs are classified as operating lease expense due to the election to not separate lease and non-lease components. These costs were not included within the measurement of the Company’s operating lease ROU assets and operating lease liabilities.
The following table presents the supplemental cash flow disclosures for cash paid for leases for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $322 | $313 |
| Operating cash flows from finance leases | $77 | $41 |
| Financing cash flows from finance leases | $307 | $175 |
(7) TERM LOAN
Oxford Finance and Silicon Valley Bank Loan
In October 2022, the Company entered into a loan and security agreement, as amended, the Loan Agreement, with Oxford Finance LLC, Oxford Finance Credit Fund II LP, and Silicon Valley Bank, or SVB, collectively the Lenders, for a secured term loan facility of up to $100.0 million. Pursuant to the Loan Agreement, the Company drew an initial loan of $10.0 million. Under the original terms of the Loan Agreement, the Company had the right to draw an additional $40.0 million through the end of June 2024. The original terms of the Loan Agreement provided for an additional $50.0 million over three tranches, with $12.5 million available in each of two tranches based upon the achievement of milestones related to the development of evorpacept and one preclinical product candidate, and $25.0 million at the Lenders’ sole discretion. The Company decided not to draw down on any portion of the $40.0 million available under the Loan Agreement by the deadline of June 30, 2024 and did not achieve all of the requirements needed to gain access to each of the two tranches available upon the achievement of pre-determined development milestones by the deadline of December 31, 2024. As a result, only the $25.0 million tranche available at the Lenders’ sole discretion was available as of March 31, 2025.
The proceeds of the loans may be used by the Company for working capital and to fund its general business requirements.
Additional information regarding our indebtedness is included in our notes to our consolidated financial statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 6, 2025.
During the three months ended March 31, 2025 and 2024, interest expense incurred in connection with the Loan Agreement was$0.3 million.
As of March 31, 2025, the Company was in compliance with all financial reporting covenants under the Loan Agreement.
As of March 31, 2025, the future maturities under the Loan Agreement are as follows (in thousands):
| 2025 | $435 |
| 2026 | 5,217 |
| 2027 | 4,948 |
| 2028 | — |
| 2029 | — |
| Total future maturities | 10,600 |
| Less: current portion of term loan | (1,739) |
| Total term loan, net of current portion | 8,861 |
| Less: unamortized debt issuance costs | (502) |
| Less: unaccreted final payment costs | (127) |
| Term loan, non-current, net | $8,232 |
(8)STOCKHOLDERS’ EQUITY
On July 21, 2020, the Company’s amended and restated certificate of incorporation became effective, authorizing 1,000,000,000 shares of common stock, $0.001 par value per share, and 100,000,000 shares of undesignated preferred stock, $0.001 par value per share. As of March 31, 2025 and December 31, 2024, the Company had 53,384,145 and 53,052,912 shares of common stock outstanding, respectively, andno shares of undesignated preferred stock outstanding, respectively.
Common stock reserved for future issuance as of March 31, 2025 consists of the following:
| Stock options issued and outstanding | 12,099,944 |
|---|---|
| RSUs issued and outstanding | 594,552 |
| PSUs issued and outstanding | 72,000 |
| Stock options authorized for future issuance | 3,157,263 |
| Employee Stock Purchase Plan shares authorized for future issuance | 1,504,780 |
| Pre-funded warrants issued and outstanding | 1,250,000 |
| Total | 18,678,539 |
At-the-Market Equity Offering
In December 2021, the Company entered into a sales agreement (as amended, Sales Agreement) with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC (Credit Suisse), under which it may offer and sell shares of the Company’s common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as the Company’s sales agents in its at-the-market (ATM) equity offering program. In August 2023, the Company entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of March 31, 2025, the Company had issued approximately 2,404,855 shares of common stock pursuant to the Sales Agreement for net proceeds of$30.0 million. The Company may terminate this ATM program at any time, pursuant to its terms.
Pre-Funded Warrants
In October 2023, the Company completed an underwritten follow-on public offering (the October 2023 Offering) pursuant to a shelf registration statement, which provides for aggregate offerings of up to $450.0 million of the Company’s securities. As part of the October 2023 underwritten public offering, the Company issued pre-funded warrants to certain investors to purchase 1,250,000 shares of common stock in an underwritten public offering at a public offering price of $6.379 per pre-funded warrant. Each pre-funded warrant entitles the holder to purchase one share of common stock at an exercise price of $0.001 per share.
As of March 31, 2025 and December 31, 2024, respectively, no shares underlying the pre-funded warrants had been exercised. All of the outstanding pre-funded warrants are included in the weighted-average number of shares of common stock used to calculate basic net loss per share attributable to common stockholders (see Note 11 “Net Loss Per Share”).
(9)STOCK-BASED COMPENSATION
Equity Incentive Plans
Amended and Restated 2020 Equity Incentive Plan
The Company’s Amended and Restated 2020 Equity Incentive Plan, or the 2020 Plan, serves as the successor to the Company’s 2020 Equity Incentive Plan and provides for the granting of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units and performance shares.
On January 1, 2025, the number of shares available under the 2020 Plan was increased by 2,122,116 shares.
2025 Inducement Equity Incentive Plan
In January 2025, the Company adopted the 2025 Inducement Equity Incentive Plan, or the 2025 Plan. The 2025 Plan provides for the granting of equity-based awards, including non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units and performance shares. A total of 1,500,000 shares were reserved under the 2025 Plan.
Performance-Based Restricted Stock Units
In February 2024, the Company granted 365,000 performance-based restricted stock units, or PSUs, to certain employees under the 2020 Plan. The PSUs are subject to both performance-based and service-based vesting conditions with a fair value based on the closing price of the underlying common stock on the date of grant. Each PSU is split into two tranches with each tranche having performance goals based on the achievement of pre-determined clinical milestones that result in the shares attributable to such tranche being eligible for vesting, subject to the service-based vesting condition. The service-based vesting condition is satisfied on the one-year anniversary of the performance achievement date for each tranche and is subject to the employee’s continuous service through such vesting date. Upon vesting, each PSU will automatically convert intoone share of the Company’s common stock. If the performance condition for a tranche is not met by March 31, 2025, the shares attributable to such tranche will be forfeited.
During the three months ended March 31, 2025, the Company determined that the performance conditions for one tranche of PSUs was achieved. As a result, compensation expense of$0.6 million has been recognized related to this tranche of PSUs as of and for the three months ended March 31, 2025. The performance conditions for the other tranche of PSUs was not achieved as of March 31, 2025, and therefore, these awards were forfeited. As of March 31, 2025, there were 72,000 PSUs outstanding and unvested.
Employee Stock Purchase Plan
Under the Company’s 2020 Employee Stock Purchase Plan, or the ESPP, eligible employees are entitled to purchase shares of common stock with accumulated payroll deductions.
Stock-based Compensation Expenses
Total stock-based compensation expense recognized in the condensed consolidated statements of operations was as follows (in thousands):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Research and development | $3,005 | $4,998 |
| General and administrative | 2,211 | 2,033 |
| Total | $5,216 | $7,031 |
(10)RELATED-PARTY TRANSACTIONS
The Company has several related-party agreements with Tallac Therapeutics, Inc., or Tallac, and with ScalmiBio, Inc., or ScalmiBio. The details of these agreements are described in our notes to our consolidated financial statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 6, 2025. During the three months ended March 31, 2025, there were no material changes to these agreements.
Tallac Service Agreement
During the three months ended March 31, 2024, the Company recorded a nominal amount as research and development, or R&D, costs in relation to the research and development services agreement with Tallac, or the Tallac Services Agreement. Per contractual terms, the Tallac Services Agreement terminated on July 1, 2024.
Tallac Collaboration Agreement
During the three months ended March 31, 2025 and 2024, the Company recorded $48,000 and$0.4 million, respectively, as R&D costs in relation to the collaboration agreement with Tallac, or the Tallac Collaboration Agreement.
As of March 31, 2025 and December 31, 2024, the Company hadaccrued expenses of $48,000 and$0.1 million, respectively, related to the Tallac Collaboration Agreement, which was presented within the payable and accrued liabilities due to related party on the condensed consolidated balance sheets.
ScalmiBio Milestone Payments
The Company has agreed to pay up to $35.0 million, in aggregate, in certain milestones based on the clinical development of the acquired ScalmiBio technology and has also agreed to pay a low single digit royalty on net sales of any products developed from the ScalmiBio acquired technology for a defined term. The Company has the option to buy-out the royalty payment, prior to the first marketing approval of the developed product.
During the three months ended March 31, 2025 and 2024, the Company madeno milestone payment and $1.0 million milestone payment, respectively, as a result of selecting a development candidate, to the stockholders of ScalmiBio, including 31.7%, or $0.3 million, to the Company’s former Chief Executive Officer and former Chief Scientific Officer and President, and 63.5%, or $0.6 million, to another employee of the Company. This milestone payment was recorded as R&D costs within the condensed consolidated statements of operations.
(11) NET LOSS PER SHARE
The following table sets forth the computation of the basic and diluted net loss per share for thethree months ended March 31, 2025 and 2024 (in thousands, except share and per share data):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Numerator: | ||
| Net loss | $(30,754) | $(35,581) |
| Denominator: | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 53,359,338 | 50,120,758 |
| Net loss per share, basic and diluted | $(0.58) | $(0.71) |
Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods presented as the inclusion of all potential common stock outstanding would have been anti-dilutive.
The following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share for thethree months ended March 31, 2025 and 2024 because including them would have been anti-dilutive:
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Stock options issued and outstanding | 12,099,944 | 9,870,347 |
| RSUs issued and outstanding | 594,552 | 1,263,321 |
| PSUs issued and outstanding | 72,000 | 365,000 |
| Employee Stock Purchase Plan estimated shares issuable | 37,684 | 1,146 |
| Total | 12,804,180 | 11,499,814 |
(12)COMMITMENTS AND CONTINGENCIES
Guarantees and Indemnifications
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its officers and directors for specified events or occurrences, subject to some limits, while they are serving at the Company’s request in such capacities. There have been no claims to date and the Company has director and officer insurance that may enable the Company to recover a portion of any amounts paid for future potential claims. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company hasnot recorded any liabilities for these agreements as of March 31, 2025.
Contingencies
From time to time, the Company may be a party to various claims in the normal course of business. Legal fees and other costs associated with such actions will be expensed as incurred. The Company will assess, in conjunction with its legal counsel, the need to record a liability for litigation and contingencies. Reserve estimates will be recorded when and if it is determined that a loss related matter is both probable and reasonably estimable. As of March 31, 2025, the Company hadno pending or threatened litigation.
Other Contractual Obligations and Other Commitments
The Company has other contractual obligations and other commitments from manufacturing and service contracts, which are presented as follows as of March 31, 2025 (in thousands):
| Total | 2025(remaining nine months) | 2026-2027 | 2028-2029 | Thereafter | |
| Manufacturing and service contracts | $2,216 | $1,800 | $416 | $— | $— |
|---|---|---|---|---|---|
| Total | $2,216 | $1,800 | $416 | $— | $— |
In November 2015, the Company entered into a Master Service Agreement, or the MSA, with KBI Biopharma, Inc. relating to formulation development, process development and current good manufacturing practices, or cGMP, manufacturing of evorpacept for use in clinical trials on a project basis. The MSA had an initial term ofthree years with successiveone-year renewal periods, which was extended an additional eight years until November 2026, is cancellable upon notice and is non-exclusive. Statements of work under the MSA commit the Company to certain future purchase obligations of approxim ately$0.9 million. In addition, the Company has commitments with three other pharmaceutical contract manufacturers, including certain future purchase obligations of approximately$1.3 million. These amounts are based on non-cancellable commitments and forecasts that include estimates of future market demand, quantity discounts and manufacturing efficiencies that may impact timing of purchases.
The Company enters into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of the Company’s service providers, up to the date of cancellation.
(13) SUBSEQUENT EVENTS
Subsequent to March 31, 2025, the Company paid approximately $1.5 million in severance payments in connection with the Company’s reduction in workforce in connection with the Company’s pipeline prioritization, clinical development and cash preservation strategy approved by the Company’s Board of Directors on February 28, 2025. The Company may incur other charges due to events that may occur as a result of, or associated with, the pipeline prioritization, clinical development and cash preservation strategy, including (but not limited to) impairment charges relating to the balances of laboratory equipment, leasehold improvements, and operating lease right-of-use assets related to the Palo Alto facility of up to $5.7 million.
Nasdaq Minimum Bid Price Compliance Notice
On April 23, 2025, the Company received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that, for the last 30 consecutive business days, the closing bid price of the Company’s common stock had closed below the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Global Select Market. The Company was provided a compliance period of 180 calendar days, or until October 20, 2025, to regain compliance with the minimum bid price requirement subject to Nasdaq rules.
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