Item 1. Financial Statements
Item 1. Financial Statements
Zenas BioPharma, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
March 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
196,554
$
319,742
Short-term investments
115,825
31,024
Restricted cash
—
90
Prepaid expenses and other current assets
5,428
5,067
Total current assets
317,807
355,923
Property and equipment, net
72
185
Operating lease right-of-use assets, net
1,204
1,004
Long-term investments
1,835
—
Other non-current assets
12,848
12,856
Total assets
$
333,766
$
369,968
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
20,018
$
17,136
Accrued expenses
28,206
39,371
Operating lease liabilities, current
908
785
Total current liabilities
49,132
57,292
Operating lease liabilities, non-current
317
218
Total liabilities
49,449
57,510
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock, par value $ 0.0001 per share; 25,000,000 shares authorized and no shares issued and outstanding as of March 31, 2025 and December 31, 2024
—
—
Common stock, par value $ 0.0001 per share; 175,000,000 shares authorized; 41,821,887 and 41,793,412 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
4
4
Additional paid-in capital
705,136
699,651
Accumulated other comprehensive income
141
194
Accumulated deficit
( 420,964 )
( 387,391 )
Total stockholders’ equity
284,317
312,458
Total liabilities and stockholders’ equity
$
333,766
$
369,968
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Zenas BioPharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended March 31,
2025
2024
Revenue:
License and collaboration revenue
$
10,000
$
—
Total revenue
10,000
—
Operating expenses:
Research and development
34,915
22,645
General and administrative
12,415
4,933
Total operating expenses
47,330
27,578
Loss from operations
( 37,330 )
( 27,578 )
Other income (expense), net:
Fair value adjustments to convertible notes
—
( 694 )
Other income, net
3,552
472
Total other income (expense), net
3,552
( 222 )
Loss before income taxes
( 33,778 )
( 27,800 )
Income tax benefit
205
—
Net loss to common stockholders
$
( 33,573 )
$
( 27,800 )
Net loss per share attributable to common stockholders - basic and diluted
$
( 0.80 )
$
( 17.89 )
Weighted-average common stock outstanding - basic and diluted
41,800,802
1,554,087
Comprehensive loss:
Net loss to common stockholders
$
( 33,573 )
$
( 27,800 )
Other comprehensive income (loss):
Unrealized gain on investments
12
—
Foreign currency translation adjustment
( 65 )
37
Comprehensive loss
$
( 33,626 )
$
( 27,763 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Zenas BioPharma, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(in thousands, except share data)
Three Months Ended March 31, 2025
Common Stock
Shares
Amount
Additional Paid-in Capital
Accumulated Other Comprehensive Income
Accumulated Deficit
Total Stockholders'
Equity
Balance as of December 31, 2024
41,793,412
$
4
$
699,651
$
194
$
( 387,391 )
$
312,458
Exercises of common stock options
28,475
—
99
—
—
99
Stock-based compensation expense
—
—
5,386
—
—
5,386
Unrealized gain on investments
—
—
—
12
—
12
Foreign currency translation adjustment
—
—
—
( 65 )
—
( 65 )
Net loss
—
—
—
—
( 33,573 )
( 33,573 )
Balance as of March 31, 2025
41,821,887
$
4
$
705,136
$
141
$
( 420,964 )
$
284,317
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Zenas BioPharma, Inc.
Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Deficit
(Unaudited)
(in thousands, except share data)
Three Months Ended March 31, 2024
Convertible Preferred Stock
Seed Series
Series A
Series B
Common Stock
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Additional Paid-in Capital
Accumulated Other Comprehensive Income
Accumulated Deficit
Total Stockholders'
Deficit
Balance as of December 31, 2023
1,785,714
$
956
17,589,380
$
55,840
81,242,587
$
193,290
1,576,854
$
—
$
4,645
$
37
$
( 230,403 )
$
( 225,721 )
Repurchase of unvested restricted stock awards
—
—
—
—
—
—
( 21,172 )
—
—
—
—
—
Exercises of common stock options
—
—
—
—
—
—
7,035
—
42
—
—
42
Stock-based compensation expense
—
—
—
—
—
—
—
—
947
—
—
947
Foreign currency translation adjustment
—
—
—
—
—
—
—
—
—
37
—
37
Net loss
—
—
—
—
—
—
—
—
—
—
( 27,800 )
( 27,800 )
Balance as of March 31, 2024
1,785,714
$
956
17,589,380
$
55,840
81,242,587
$
193,290
1,562,717
$
—
$
5,634
$
74
$
( 258,203 )
$
( 252,495 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Zenas BioPharma, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
Three Months Ended March 31,
2025
2024
Cash flows from operating activities:
Net loss
$
( 33,573 )
$
( 27,800 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
23
33
Loss on disposal of property and equipment
107
—
Net amortization of premiums and accretion of discounts on investments
( 382 )
—
Stock-based compensation expense
5,386
947
Change in fair value of convertible notes
—
694
Non-cash lease expense
246
159
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 353 )
1,787
Accounts payable
2,882
3,407
Accrued expenses
( 11,165 )
335
Operating lease liabilities
( 222 )
( 164 )
Other current liabilities
—
1,500
Net cash used in operating activities
( 37,051 )
( 19,102 )
Cash flows from investing activities:
Purchases of property and equipment
( 18 )
( 22 )
Purchases of investments
( 99,114 )
—
Proceeds from sales and maturities of investments
12,858
—
Net cash used in investing activities
( 86,274 )
( 22 )
Cash flows from financing activities:
Payment of initial public offering costs
—
( 656 )
Proceeds from exercise of stock options
99
42
Net cash provided by (used in) financing activities
99
( 614 )
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 52 )
36
Net decrease in cash, cash equivalents and restricted cash
( 123,278 )
( 19,702 )
Cash, cash equivalents and restricted cash at beginning of period
319,832
56,942
Cash, cash equivalents and restricted cash at end of period
$
196,554
$
37,240
Supplemental disclosure of non-cash investing and financing activities:
Right-of-use assets obtained under operating lease arrangements
$
445
$
—
Deferred offering costs in accounts payable and accrued expenses
$
—
$
1,872
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents
$
196,554
$
37,154
Restricted cash
—
86
Total cash, cash equivalents and restricted cash
$
196,554
$
37,240
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Zenas BioPharma, Inc.
Notes to Condensed Consolidated Financial Statements
1. Nature of Business
Organization
Zenas BioPharma, Inc. (“Zenas” or the “Company”) was incorporated in November 2019 as Zenas BioPharma (Cayman) Limited, an exempted company incorporated in the Cayman Islands with limited liability and commenced operations in 2020. On August 2, 2023, the Company (then known as Zenas BioPharma (Cayman) Limited) de-registered from the Cayman Islands and registered by way of continuation in the State of Delaware. Zenas is a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies for patients in need. The Company’s goal is to build an immunology and inflammation (“I&I”) focused biopharmaceutical company. The Company has in-licensed and is developing several product candidates for the treatment of various auto-immune and rare diseases. The Company is headquartered in Waltham, Massachusetts and operates in one segment, which is the business of acquiring and developing immune-based therapies for potential commercialization.
The Company’s condensed consolidated financial statements include the accounts of its wholly owned subsidiaries which include Zenas BioPharma (HK) Limited (“Zenas HK”), Zenas BioPharma (USA) LLC, Shanghai Zenas Biotechnology Co. Limited, Zenas BioPharma Securities Corp., and Zenas BioPharma GmbH.
Liquidity and Capital Resources
Since its inception, the Company has devoted its efforts principally to research and development, and raising capital. The Company is subject to risks and uncertainties common to clinical stage companies in the biopharmaceutical industry, including, but not limited to, completing preclinical studies and clinical trials, obtaining regulatory approval for product candidates, market acceptance of products, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, reliance on third-party organizations, protection of proprietary technology, compliance with government regulations, and the ability to raise additional capital to fund operations. The Company’s revenues to date have been generated from payments received under the Company’s license and collaboration agreement with Bristol-Myers Squibb Company (“BMS”), novation agreement with Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and license agreement with Zai Lab (Hong Kong) Limited (“Zai”) (please see Note 7, License and Collaboration Revenue , to these condensed consolidated financial statements). The Company has not generated any revenue from product sales since inception, and its product candidates currently under development will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization.
On September 16, 2024, the Company completed its initial public offering (“IPO”), in which the Company issued and sold 15,220,588 shares of its common stock, including 1,985,294 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $ 17.00 per share, for aggregate gross proceeds of $ 258.7 million. The Company received $ 234.3 million in net proceeds after deducting underwriting discounts, commissions and other offering expenses. In connection with the IPO, all outstanding shares of convertible preferred stock converted into 24,978,715 shares of the Company’s common stock.
In connection with, and prior to, the Company’s IPO, the Company effected a 1-for- 8.6831 reverse stock split of the Company’s issued and outstanding common stock and adjusted the conversion ratio of all the Company’s outstanding convertible preferred stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the reverse stock split and the adjustment of the preferred stock conversion ratios.
The Company has incurred operating losses and negative cash flows, since its inception, including net losses of $ 33.6 million and $ 27.8 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, the
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Company had an accumulated deficit of $ 421.0 million. Management expects operating losses and negative operating cash flows to continue for the foreseeable future.
The Company expects that its existing cash, cash equivalents and investments of $ 314.2 million as of March 31, 2025 will be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from the date this Form 10-Q is filed. The Company will need additional financing to support its continuing operations and to pursue its growth strategy. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations through a combination of private or public equity financings, debt financings or other capital sources, including collaborations with other companies or other strategic transactions and licensing agreements. The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all. The inability to raise capital as and when needed could have a negative impact on the Company’s financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.
2. Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in Note 2, Summary of Significant Accounting Policies, in the audited consolidated financial statements for the year ended December 31, 2024, and notes thereto, included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 11, 2025. Since the date of those financial statements, there have been no material changes to the Company’s significant accounting policies.
Basis of Presentation and Consolidation
The accompanying condensed consolidated financial statements include the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts, transactions, and balances have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). 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 Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been or omitted pursuant to such rules and regulations.
Unaudited Interim Financial Information
The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025, and the results of operations and its cash flows for the three months ended March 31, 2025 and 2024. The financial data and other information disclosed in these notes related to the three months ended March 31, 2025 and 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K as filed with the SEC, on March 11, 2025.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. The Company bases its estimates on historical experience, known trends and other market-specific factors or other relevant factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis using such factors and adjusts those estimates and assumptions as facts and circumstances dictate. Actual results may differ from those estimates or assumptions. Significant estimates in these condensed consolidated financial statements include estimates made in connection with accrued research and development expenses, stock-based compensation and pre-initial public offering (“IPO”) valuations of common stock.
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Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgement. As of the date of the issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgements or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the “FASB” or other standard setting bodies that we adopt as of the specified effective date. Unless otherwise discussed, we do not believe that the adoption of recently issued standards have or may have a material impact on our condensed consolidated statements or disclosures.
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3. Fair Value Measurements
The following table presents information about the Company’s assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands):
As of March 31, 2025
Description
Total Carrying Value
Quoted Prices in Active Market
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Other Observable Inputs
(Level 3)
Assets:
Cash
$
23,721
$
23,721
$
—
$
—
Money market funds
172,833
172,833
—
—
Short-term investments:
Commercial paper
6,387
—
6,387
—
Corporate debt securities
45,418
—
45,418
—
Government securities
64,020
64,020
—
—
Long-term investments:
Corporate debt securities
1,835
—
1,835
—
Total assets
$
314,214
$
260,574
$
53,640
$
—
As of December 31, 2024
Description
Total Carrying Value
Quoted Prices in Active Market
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Other Observable Inputs
(Level 3)
Assets:
Cash
$
19,070
$
19,070
$
—
$
—
Money market funds
300,672
300,672
—
—
Short-term investments:
Commercial paper
3,315
—
3,315
—
Corporate debt securities
8,601
—
8,601
—
Government securities
19,108
19,108
—
—
Total assets
$
350,766
$
338,850
$
11,916
$
—
There have been no material impairments of our assets measured and carried at fair value as of March 31, 2025 and December 31, 2024. In addition, there have been no changes in valuation techniques as of March 31, 2025 and December 31, 2024. The fair value of Level 1 instruments classified as money market funds and government securities are valued using quoted market prices in active markets. The fair value of Level 2 instruments classified as short-term investments was determined using other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date and fair value is determined using models or other valuation methodologies. During the three months ended March 31, 2025 and year ended December 31, 2024, there were no transfers between levels.
The short and long-term investments are classified as available-for-sales securities. As of March 31, 2025, the remaining contractual maturities of the available-for-sales securities were 1 to 18 months , the balance in the Company’s accumulated other comprehensive income was comprised of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three months ended March 31, 2025 and 2024. As a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the same period. The Company had a limited number of available-for-sale securities in
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insignificant loss positions as of March 31, 2025, which the Company does not intend to sell and has concluded will not be required to sell before recovery of amortized cost for the investment maturity.
The following table summarizes the available-for-sale securities (in thousands):
As of March 31, 2025
Amortized Cost
Gross Unrealized Gains
Gross Unrealized Losses
Fair Value
March 31, 2025
Commercial paper
$
6,378
$
9
$
—
$
6,387
Corporate debt securities
47,228
29
( 4 )
47,253
Government securities
64,011
13
( 4 )
64,020
Total
$
117,617
$
51
$
( 8 )
$
117,660
As of December 31, 2024
Amortized Cost
Gross Unrealized Gains
Gross Unrealized Losses
Fair Value
December 31, 2024
Commercial paper
$
3,311
$
4
$
—
$
3,315
Corporate debt securities
8,589
12
—
8,601
Government securities
19,093
17
( 2 )
19,108
Total
$
30,993
$
33
$
( 2 )
$
31,024
Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the condensed consolidated balance sheets and are not included in the table above.
4. Other Assets
Other assets consisted of the following (in thousands):
March 31, 2025
December 31, 2024
Clinical trial deposits
$
12,639
$
12,639
Other
209
217
Total other assets
$
12,848
$
12,856
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
March 31, 2025
December 31, 2024
External research, development and manufacturing expenses
$
23,588
$
29,338
Employee compensation and benefits
3,383
8,308
Professional and consultant fees
846
1,265
Income taxes payable
5
211
Other
384
249
Total accrued expenses
$
28,206
$
39,371
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6 . Leases
The Company has various leases for office space, which are accounted for as operating leases and generally have terms of less than two years in length, some of which have the option to renew. The Company recognizes monthly operating lease expense on a straight-line basis over the term of the lease as general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss. Variable lease expense relates primarily to office lease common area maintenance, insurance, and property taxes, and it is expensed as incurred. Variable lease expense is also excluded from the calculation of lease liabilities and right-of-use-assets.
The minimum lease payments under the Company’s operating leases are expected to be as follows (in thousands):
Fiscal Year
Amount
2025 (remaining nine months)
$
713
2026
453
2027
136
Thereafter
—
Total future minimum lease payments
1,302
Less: imputed interest
( 77 )
Total operating lease liabilities
$
1,225
7 . License and Collaboration Revenue
License and Collaboration Agreement with Bristol-Myers Squibb
In August 2023, the Company entered into a license and collaboration agreement (the “BMS Agreement”) with BMS, under which the Company granted BMS an exclusive license to (i) develop, manufacture (subject to the Company’s rights to be the exclusive manufacturer for BMS for a certain period of time), commercialize or otherwise exploit obexelimab and any biological product (irrespective of presentations, formulations or dosages) containing obexelimab but not any of the Company’s other proprietary active ingredient (the “BMS Product”) into Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia (collectively, the “BMS Territory”) and (ii) develop and manufacture obexelimab and the BMS Product outside the BMS Territory provided that obexelimab and the BMS Product are solely used in the BMS Territory.
Pursuant to the BMS Agreement, BMS paid the Company a one-time non-refundable upfront cash payment of $ 50.0 million. The Company is entitled to receive further separate development, regulatory milestone payments from BMS of up to approximately $ 79.5 million. The Company is also entitled to receive one-time sales milestone payments up to $ 70.0 million upon BMS achieving certain net sales milestones in a given year in the BMS Territory. The Company is also eligible to receive tiered high single-digit to low double-digit royalties on net sales in the BMS Territory, subject to specified reductions.
The Company will continue to perform and oversee the ongoing Phase 3 trial of obexelimab in the IgG4-RD indication and BMS will participate in the performance of the study. BMS will fund their pro rata share of the total global study costs up to a specified percentage of the patients enrolled in the study from the BMS Territory. Should the percentage of patients from the BMS Territory fall below the specified percentage, BMS’s funding would proportionately decrease. The global development activities under the agreement do not represent a transaction with a customer and reimbursement payments received by the Company for global development activities are accounted for as a reduction of the related research and development expenses.
For the three months ended March 31, 2025 and 2024, the Company recorded $ 1.7 million and $ 1.0 million, respectively, as a receivable included in prepaid expenses and other current assets. The Company recorded $ 1.7 million and $ 1.0 million for the three months ended March 31, 2025 and 2024, respectively, as a reduction to research and development expense for global development costs to be reimbursed by BMS. The Company did not recognize revenue related to the BMS Agreement during the three months ended March 31, 2025 and 2024.
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Tenacia Biotechnology Co. Novation Agreement
In October 2024, the Company entered into a novation agreement with Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”), under which the Company transferred its rights and obligations under the agreements with Dianthus to Tenacia (the “Tenacia Agreement”). Pursuant to the Tenacia Agreement, the Company, transferred all the ZB005 inventory, analytical methods and manufacturing records generated, under the Dianthus Option Agreement and License Agreement (collectively the “Dianthus Agreements”) to Tenacia, for the exclusive right to research, develop, manufacture and commercialize products within China, Hong Kong, Macau and Taiwan (“greater China”). As a result of the Tenacia Agreement, the Company has no further obligations to Dianthus pursuant to the Dianthus Agreements.
Pursuant to the Tenacia Agreement, Tenacia paid the Company a one-time non-refundable upfront cash payment of $ 5.0 million, which was recognized as revenue in the fourth quarter of 2024. The Company is entitled to receive further development, regulatory and sales milestones from Tenacia of up to approximately $ 86.0 million if certain milestones are successfully achieved. The Company did not recognize revenue related to the Tenacia Agreement during the three months ended March 31, 2025 and 2024.
License Agreement with Zai Lab (Hong Kong) Limited
In January 2025, the Company entered into a license agreement (the “Zai License Agreement”), with Zai, under which the Company granted Zai an exclusive sublicense to develop, manufacture and commercialize ZB001 and related programs in greater China. Under the Zai Agreement, Zai will be responsible for conducting all research and development activities, manufacturing, regulatory and commercialization in greater China.
Pursuant to the Zai Agreement, Zai paid the Company a one-time non-refundable upfront cash payment of $ 10.0 million. The Company is entitled to receive further development, regulatory and sales milestones from Zai up to approximately $ 117.0 million if certain milestones are successfully achieved, with passthrough obligations of $ 21.0 million due to Viridian. The Company is also eligible to receive tiered royalties on net sales in greater China, ranging from the low to mid-single digits, net of passthrough obligations due to Viridian.
The Company evaluated the terms of the Zai Agreement and determined it is within the scope of ASC 606. The Company identified the following promises in the Zai Agreement that were evaluated under the scope of ASC 606: (i) transfer of the license for ZB001, (ii) licensed technology transfer (iii) licensed material transfer and (iv) continued licensed technology transfer. The Company also evaluated whether certain options outlined in the Zai Agreement represented material rights that would give rise to a performance obligation and concluded that none of the options conveyed a material right to Zai or were immaterial and, therefore, are not considered separate performance obligations within the Zai Agreement.
The Company assessed the above promises and determined that the license for ZB001 and technology transfer are a combined distinct performance obligation within the scope of ASC 606. The licensed material transfer and the continued technology know-how transfer services are promises that are separately identifiable and considered to be distinct. The Company determined the transfer of the licensed materials and continued technology know-how transfer services were immaterial in the context of the contract based on the minimal resources required to fulfill the obligations and the estimated standalone selling price of the licensed materials. Therefore, the sublicense and technology transfer represent a single performance obligation at contract inception.
The Company concluded that the transaction price of $ 10.0 million was allocated to the combined performance obligation, which was recognized upon delivery prior to March 31, 2025. The Company used the most likely amount method to estimate variable consideration and estimated that the most likely amount for each potential developmental and regulatory variable consideration milestone payment under the agreement is zero, as achievement of those milestones is uncertain and susceptible to factors outside the Company’s control. Accordingly, all such milestone payments were excluded from the transaction price. Management will reevaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, will adjust the transaction price as necessary. Sales and royalty based milestones structured on the level of sales, were also excluded from the transaction price, as the license is deemed to be the predominant item to which the transaction price relates. The Company will recognize such milestone and
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royalty 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).
As of March 31, 2025, no milestones were achieved or deemed probable of achievement.
8. License Agreements
License Agreements with Xencor, Inc.
2020 Xencor Agreement
In September 2020, the Company entered into a license agreement (the “2020 Xencor Agreement”) with Xencor, Inc. (“Xencor”), under which the Company is required to pay Xencor tiered royalties on annual net sales of successfully commercialized products, including ZB002 and ZB004. The royalty percentage rates vary by geographic areas as defined in the 2020 Xencor Agreement and range from the mid-single digits to mid-teens. The Company is also obligated to reimburse Xencor for third-party costs incurred for certain patent filings, prosecution and maintenance as further specified in the 2020 Xencor Agreement. During the three months ended March 31, 2025 and 2024, the Company incurred no such reimbursable costs.
2021 Xencor Agreement
In May 2021, the Company entered into a license agreement with Xencor (the “2021 Xencor Agreement”), under which the Company obtained an exclusive, royalty-bearing, sublicensable worldwide license to research, develop, manufacture, market and sell obexelimab. The Company is also obligated to make regulatory milestone payments up to $ 75.0 million and one-time sales milestone payments up to $ 385.0 million upon achieving milestone events of net sales in a given calendar year in the territory equal to certain threshold amounts. In addition, the Company is required to pay Xencor tiered royalties on annual net sales of successfully commercialized products utilizing obexelimab, with the royalty percentages varying based on regions and ranging from the mid-single digits to the mid-teens.
For the three months ended March 31, 2025 and 2024, the Company recorded no reimbursable patent-related costs, respectively.
License Agreement with Viridian Therapeutics, Inc.
In October 2020, the Company entered into a license agreement with Viridian Therapeutics, Inc. (the “Viridian Agreement”) to obtain an exclusive, royalty-bearing, sublicensable license to research, develop, manufacture, market and sell certain antibody product candidates based on Viridian’s proprietary technology. The Company’s license rights are limited to non-oncology indications and are limited to China, Hong Kong, Macau and Taiwan (“Zenas Territories”). Viridian retains its rights to develop and commercialize such product candidates outside of the Zenas Territories. In December 2021, the Company and Viridian entered into two letter agreements to authorize initiation of certain manufacturing and development activities related to the licensed product candidate, ZB001. Under the terms of the letter agreements, Viridian engaged a third-party contract manufacturer to initiate certain work related to ZB001. In May 2022, the Company entered into a manufacturing development and supply agreement (“Viridian Supply Agreement”). In January 2025, the Company entered into a third amendment to the Viridian Agreement, under which the Company is obligated to make development and sales milestone payments to Viridian, totaling $ 21.0 million, based on achievement of certain specified development and sales milestones, and royalties on net sales.
In January 2025, the Company entered the Zai License Agreement under which the Company granted Zai an exclusive sublicense to develop, manufacture and commercialize ZB001 and related programs in greater China. In connection with the Zai License Agreement, the Company assigned the Viridian Supply Agreement to Zai. For additional information on the Zai Agreement, please see License Agreement with Zai Lab (Hong Kong) Limited in Note 7 – License and Collaboration Revenue to these condensed consolidated financial statements.
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During the three months ended March 31, 2025 and 2024, the Company recognized no expense related to Viridian contract manufacturing organization (“CMO”) costs. Viridian has agreed to reimburse the Company for certain services the Company performs on Viridian’s behalf, with reimbursements being recorded as a reduction in research and development expenses. During the three months ended March 31, 2025, the Company recorded $ 0.1 million in reimbursable expenses. During the three months ended March 31, 2024, the Company had no reimbursable expenses. Additionally, during the three months ended March 31, 2025 and 2024, no milestones were achieved.
9. Common Stock
In September 2024, upon the completion of the IPO, the Company restated its certificate of incorporation, pursuant to which the Company is authorized to issue 175,000,000 shares of $ 0.0001 par value common stock. The voting, dividend and liquidation rights of the holders of the Company’s common stock were subject to and qualified by the rights, powers and preference of the holders of any preferred stock then issued and outstanding.
The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are no cumulative voting rights.
The Company had reserved the following shares of common stock for the potential conversion of outstanding stock options:
March 31, 2025
December 31, 2024
Options to purchase common stock
8,670,569
8,706,197
Remaining shares reserved for future issuance
2,456,222
359,399
Employee stock purchase plan
815,890
397,956
Total
11,942,681
9,463,552
10. Stock-Based Compensation
2024 Plan
On September 3, 2024, the Board of Directors (the “Board”) adopted the 2024 Equity Incentive Plan (the “2024 Plan”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO. The 2024 Plan provides for the award of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, unrestricted stock, restricted stock units and other stock-based awards.
The number of shares reserved and available for issuance under the 2024 Plan will automatically increase each January 1, beginning on January 1, 2025 through January 1, 2034, by the number of shares equal to the lesser of (i) five percent of the aggregate number of shares of common stock outstanding as of such date, and (ii) a number of shares as may be determined by the Board on or prior to such date. In January 2025, the number of shares of common stock available for issuance under the Company’s 2024 Plan, was increased by 2,089,670 shares of common stock due to the automatic annual provision to increase shares of common stock available under the 2024 Plan. As of March 31, 2025, 2,456,222 shares of common stock were available for issuance under the 2024 Plan.
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Stock Options
The Company has granted stock-based awards with either service or performance based vesting conditions. Compensation expense related to awards to employees and directors with service based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance based vesting conditions is recognized based on the grant date fair value once the achievement of the performance condition is probable.
The following table presents a summary of the Company’s stock option activity and related information:
Number of Shares
Weighted - Average Exercise Price
Weighted-Average Remaining Contractual Term (in years)
Aggregate Intrinsic Value
(in thousands)
Outstanding - December 31, 2024
8,706,197
$
13.21
$
2,104
Granted
108,000
$
7.28
Exercised
( 28,475 )
$
3.48
$
136
Forfeited or cancelled
( 115,153 )
$
13.94
Outstanding - March 31, 2025
8,670,569
$
13.16
8.53
$
1,877
Options vested and exercisable as of March 31, 2025
1,434,494
$
7.93
5.62
$
1,708
Options vested and expected to vest as of March 31, 2025
8,670,569
$
13.16
8.53
$
1,877
The aggregate intrinsic value of the stock options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock for those stock options that had an exercise price lower than the fair value of the Company’s common stock as of the measurement date of March 31, 2025.
As of March 31, 2025, there was $ 68.4 million of unrecognized stock-based compensation related to stock options, which is expected to be recognized over a weighted-average period of 3.15 years.
The Company recognized stock-based compensation expense related to the issuance of equity awards to employees and directors in the condensed consolidated statement of operations as follows (in thousands):
Three Months Ended March 31,
2025
2024
Research and development
$
1,581
$
411
General and administrative
3,805
536
Total stock-based compensation expense
$
5,386
$
947
Employee Stock Purchase Plan
On September 3, 2024, the Board adopted the 2024 Employee Stock Purchase Plan (the “ESPP”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO. The number of shares of common stock available under the ESPP will automatically increase on January 1st of each year, beginning on January 1, 2025 through January 1, 2034, by the number of shares equal to the lesser of (i) one percent of the aggregate number of shares of common stock outstanding as of such date, and (ii) a number of shares as may be determined by the Board on or prior to such date, up to a maximum of 1,000,000 shares in the aggregate per year. On January 1, 2025, the number of shares of common stock authorized for issuance under the ESPP increased automatically by 417,934 shares and as of March 31, 2025, a total of 815,890 shares were available for future issuance under the ESPP. There were no shares issued under the ESPP during the three months ended March 31, 2025.
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11. Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):
Three Months Ended March 31,
2025
2024
Numerator:
Net loss attributable to common stockholders
$
( 33,573 )
$
( 27,800 )
Denominator:
Weighted-average common stock outstanding - basic and diluted
41,800,802
1,554,087
Net loss per share attributable to common stockholders - basic and diluted
$
( 0.80 )
$
( 17.89 )
The Company’s potentially dilutive securities, which include convertible preferred stock, restricted stock and stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following shares from the computation of diluted net loss per share attributable to common stockholders as of March 31, 2025 and 2024 because including them would have had an anti-dilutive effect:
March 31,
2025
2024
Convertible preferred stock
—
100,617,681
Unvested restricted stock
—
3,767
Options to purchase common stock
8,670,569
2,403,183
12. Commitments and Contingencies
Operating Leases
The Company has entered into arrangements for leases of office space; see Note 6, Leases , for details.
License Agreements
The Company entered into license agreements under which it is obligated to make fixed and contingent payments; see Note 8, License Agreements , for details.
Other Contracts
The Company has entered into agreements with certain vendors for the provision of services that the Company is not contractually able to terminate for convenience and thereby avoid any and all future obligations to the vendors. Under such agreements, the Company is contractually obligated to make certain minimum payments to the vendors, with the exact amounts in the event of termination to be based on the timing of the termination and the exact terms of the agreement. As of March 31, 2025, our total non-cancellable clinical manufacturing contract payment obligations are $ 18.4 million of which the full obligation is payable within 12 months.
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Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and certain officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and had not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of March 31, 2025.
Litigation and Other Proceedings
The Company may periodically become subject to legal proceedings and claims arising in the ordinary course of business. As of March 31, 2025, the Company was not subject to any material legal proceedings which would reasonably be expected to have a material adverse effect on the Company’s financial results.
13. Related Party Transactions
Xencor, Inc.
The Company has obtained exclusive, worldwide licenses from Xencor to research, develop, manufacture, market and sell three antibody product candidates pursuant to two license agreements. The Company has concluded that Xencor is a related party, due to the issuance of convertible preferred stock in December 2020 and April 2023. In connection with the completion of the IPO, in September 2024, all outstanding shares of preferred stock converted into shares of common stock. As of March 31, 2025, Xencor held less than 10 % of shares of the Company’s outstanding common stock.
Viridian Therapeutics, Inc.
The Company has obtained a license from Viridian to research, develop, manufacture, market and sell an antibody product candidate in China. The Company has concluded that Viridian is a related party because although Fairmount Funds Management LLC owns less than 10 % of shares of the Company’s outstanding common stock, they have a seat on the Board and are also a 10% or greater stockholder of Viridian and have two seats on Viridian’s board of directors. As initial consideration for this license, the Company issued 38,707 shares of its common stock to Viridian during the year ended December 31, 2020. As of March 31, 2025, Viridian held 0.1 % of shares of the Company’s outstanding common stock.
Zai Lab (Hong Kong) Limited
The Company has granted a sublicense to Zai to develop, manufacture and commercialize ZB001 and related programs in greater China. The Company has concluded that Zai is a related party, as the Company’s CEO and Chairman is a member of Zai’s board of directors.
For additional information on these arrangements, please see Note 7, License and Collaboration Revenue and Note 8, License Agreements, to these condensed consolidated financial statements.
14. Segment Information
The Company manages its operations on a consolidated basis as a single reportable segment focused on the research and development of precision immunology-based therapies. The accounting policies of the single reportable segment are identical to those described in Note 2, Summary of Significant Accounting Policies . When evaluating the Company’s financial performance, the Company’s chief operating decision-maker (the “CODM”), its Chief Executive Officer regularly reviews consolidated net loss, total expense and direct expenses by program and compared to budget. The CODM
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allocates resources based on the Company’s available cash resources, forecasted expenditures on a consolidated basis, as well as an assessment of the probability of success of its research and development activities on a program basis. Segment asset information regularly provided to the CODM is consistent with that reported on the consolidated balance sheets with particular emphasis on the Company’s available liquidity, including its cash, cash equivalents and marketable securities balances. Revenue is primarily attributed to individual countries based on the entity owning the license, During the three months ended March 31, 2025, revenue was attributed to Zenas HK. The Company did not recognize revenue during the three months ended March 31, 2024.
The following table presents certain financial data for the Company’s reportable segments for the three months ended March 31, 2025 and 2024 (in thousands):
March 31,
2025
2024
Revenue
$
10,000
$
-
Less:
Direct research and development expenses: 1
Obexelimab
23,491
12,295
Other programs (ZB002 & ZB004)
203
894
Partnered regional programs (ZB001 & ZB005)
99
1,588
Unallocated research and development 2
9,541
7,457
General and administrative 3
8,610
4,397
Stock-based compensation
5,386
947
Other segment items 4
( 3,757 )
222
Segment net loss
$
( 33,573 )
$
( 27,800 )
1 Direct research and development expenses primarily consist of direct costs incurred to specific program research and development activities, including costs to conduct clinical trials and to manufacture clinical drug supply.
2 Unallocated research and development expenses primarily consist of indirect costs incurred in support of overall research and development activities and non-specific programs, including activities that benefit multiple programs, such as personnel costs for employees involved in research and development activities, excluding stock-based compensation, as well as contract services not allocated to specific programs.
3 General and administrative expenses primarily consist of professional fees, depreciation expense, facilities expenses as well as all other personnel costs, excluding stock-based compensation.
4 Other segment items consist of other income (expense), net and income tax benefit (provision). Other income (expense), net consists of interest income and realized and unrealized gains and losses on foreign currency transactions .
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.