Climb Bio, Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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Mar 31, 2025 · Filed May 14, 2025
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Notes to Condensed Consolidated Financial Statements
- Description of Organization and Summary of Significant Accounting Policies
Organization
Climb Bio, Inc. (the Company), is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes budoprutug and CLYM116.
Budoprutug is an anti-CD19 monoclonal antibody designed to treat a broad range of B-cell mediated diseases. The Company is currently developing budoprutug for the treatment of primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus. CLYM116 is an anti-APRIL (A Proliferation-Inducing Ligand) monoclonal antibody currently being developed for the treatment of immunoglobin A nephropathy (IgAN). The Company was incorporated on October 18, 2018 in Delaware, and its corporate headquarters are in Massachusetts.
On June 27, 2024, the Company completed its acquisition of Tenet Medicines, Inc. (the Acquisition). In connection with the closing of the Acquisition, the Company issued and sold 31,238,282 shares of its common stock at a price of $3.84 per share in a private placement to several accredited institutional investors (the Private Placement). The Company received aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting offering costs of $0.3 million. For additional information on the Acquisition and Private Placement, please refer to Note 2, Asset Acquisition and Private Placement with a Related Party, in these unaudited condensed consolidated financial statements.
On January 8, 2025, the Company entered into a technology transfer and exclusive license agreement (the Mabworks Agreement) with Beijing Mabworks Biotech Co., Ltd. (Mabworks), for rights to develop and commercialize CLYM116 for all indications worldwide outside of mainland China, Hong Kong, Macau, and Taiwan (Greater China). For additional information on the Mabworks Agreement, please refer to Note 5, License Agreements, in these unaudited condensed consolidated financial statements.
Basis of Presentation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements of the Company and its wholly owned subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States (U.S. GAAP) and accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) for Quarterly Reports on Form 10-Q. All intercompany transactions and balances have been eliminated in consolidation.
The accompanying condensed consolidated balance sheet as of March 31, 2025, and condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of cash flows, and condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2025 and 2024, are unaudited. The consolidated balance sheet as of December 31, 2024 was derived from the audited financial statements as of and for the year ended December 31, 2024, but does not include all disclosures required by U.S. GAAP. The unaudited interim condensed consolidated financial statements have been prepared on a basis consistent with the audited annual financial statements as of and for the year ended December 31, 2024, and, in the opinion of management, reflect all adjustments, consisting solely of normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025, the condensed results of its operations as of the three months ended March 31, 2025 and 2024, 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 also unaudited. The condensed results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the full year ending December 31, 2025 or any other period. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025.
Liquidity
Since inception, the Company has experienced recurring losses from operations and generated negative cash flows from operations. The Company has an accumulated deficit of $250.7 million as of March 31, 2025 and expects to incur additional losses from operations in the future.
In March 2025, the Company entered into an Equity Distribution Agreement (the Distribution Agreement) with Oppenheimer & Co. Inc., as agent (Oppenheimer), pursuant to which the Company may offer and sell shares of its common stock from time to time through Oppenheimer having an aggregate offering price of up to $22.35 million in an at the market offering. During the three months ended March 31, 2025, the Company did not issue and sell any shares of its common stock pursuant to the Distribution Agreement.
The Company believes the available cash, cash equivalents and marketable securities of $197.8 million as of March 31, 2025 will be sufficient to meet its projected operating requirements for at least the next twelve months from the filing date of these unaudited condensed consolidated financial statements, and the Company anticipates that it will need to raise substantial financing in the future to fund its operations.
The Company may finance future cash needs through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or other strategic arrangements. There are no assurances that the Company will be able to raise sufficient amounts of funding in the future on acceptable terms, or at all.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Key management estimates include those related to the accrual of research and development expenses and the valuation of stock-based awards. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company’s cash is held by one financial institution in the United States (U.S.) and one financial institution in the United Kingdom (U.K.). The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company’s deposits held in the U.S. and U.K. may exceed the Federal Depository Insurance Corporation’s and Financial Services Compensation Scheme’s, respectively, insured limits. As of March 31, 2025, the Company had investments in money market funds and marketable securities, which are held in a segregated account at a third-party custodian. The Company has established guidelines relative to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. Through March 31, 2025, and the date of this filing, the Company has not experienced any losses on such investments.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on single-source vendors and collaborators, availability of raw materials, patentability of the Company’s product candidates and processes and clinical efficacy and safety of the Company’s product candidates, compliance with government regulations and the need to obtain additional financing to fund operations. Budoprutug, CLYM116, or any product candidate the Company may develop will require significant additional research and development efforts, including extensive preclinical studies, clinical trials, and regulatory approval, prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting.
There can be no assurance that any future research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any product candidates developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if any future product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
Segments
The Company hasone operating and reportable segment. Financial information about the Company’s operating segment and the evaluation of segment results is discussed further in Note 9, Segments, to these unaudited condensed consolidated financial statements.
Fair Value Measurement
Assets and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability 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. The Company measures fair value based on a three-tier hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liabilities. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
In determining fair value, the Company utilizes quoted market prices, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
There wereno transfers into or out of Level 3 for any of the periods presented.
The Company’s fair value measurements as of March 31, 2025 and December 31, 2024 were as follows (in thousands):
| Level 1 | Level 2 | Balance | |
|---|---|---|---|
| Assets: | |||
| Cash equivalents: | |||
| Money market funds | $28,179 | $— | $28,179 |
| Marketable securities: | |||
| U.S. Treasury securities | 54,016 | — | 54,016 |
| Corporate bonds | — | 102,317 | 102,317 |
| U.S. government agency debt securities | — | 12,492 | 12,492 |
| Total marketable securities | 54,016 | 114,809 | 168,825 |
| Total assets | $82,195 | $114,809 | $197,004 |
| Level 1 | Level 2 | Balance | |
|---|---|---|---|
| Assets: | |||
| Cash equivalents: | |||
| Money market funds | $85,612 | $— | $85,612 |
| Marketable securities: | |||
| U.S. Treasury securities | 54,307 | — | 54,307 |
| Corporate bonds | — | 67,492 | 67,492 |
| U.S. government agency debt securities | — | 3,501 | 3,501 |
| Total marketable securities | 54,307 | 70,993 | 125,300 |
| Total assets | $139,919 | $70,993 | $210,912 |
Summary of Significant Accounting Policies
There have been no revisions in the Company’s significant accounting policies described in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07 (ASU 2023-07), Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which requires, among other things, the following: (i) enhanced disclosures about significant segment expenses that are regularly provided to the CODM and included in a segment’s reported measure of profit or loss; (ii) disclosure of the amount and description of the composition of other segment items, as defined in ASU 2023-07, by reportable segment; and (iii) reporting the disclosures about each reportable segment’s profit or loss and assets on an annual and interim basis. The provisions of ASU 2023-07 were effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company adopted ASU 2023-07 on December 31, 2024, and applied the amendments retrospectively to all prior periods presented in these unaudited condensed consolidated financial statements (see Note 9, Segments, to these unaudited condensed consolidated financial statements).
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU No. 2023-09 (ASU 2023-09), Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires, among other things, the following for public business entities: (i) enhanced disclosures of specific categories of reconciling items included in the rate reconciliation, as well as additional information for any of these items meeting certain qualitative and quantitative thresholds; (ii) disclosure of the nature, effect and underlying causes of each individual reconciling item disclosed in the rate reconciliation and the judgment used in categorizing them if not otherwise evident; and (iii) enhanced disclosures for income taxes paid, which includes federal, state, and foreign taxes, as well as for individual jurisdictions over a certain quantitative threshold. The amendments in ASU 2023-09 eliminate the requirement to disclose the nature and estimate of the range of the reasonably possible change in unrecognized tax benefits for the 12 months after the balance sheet date. The effective date of this update for non-public companies is for fiscal years beginning after December 15, 2025; early adoption is permitted. The Company expects ASU 2023-09 to require additional disclosures in the notes to its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03 (ASU 2024-03), Disaggregation of Income Statement Expenses, which requires additional disclosures about specific types of expenses included in the expense captions presented on the face of the income statement, as well as disclosures about selling expenses. The provisions of ASU 2024-03 are effective for public business entities for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted. The guidance is to be applied prospectively, with the option for retrospective application. The Company is currently evaluating the impact of ASU 2024-03 on its consolidated financial statements.
There were no other significant updates to the recently issued accounting standards other than as disclosed herewith for the three months ended March 31, 2025. Although there are several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results.
Note 2. Asset Acquisition and Private Placement with a Related Party
Background
The Company entered into (i) an Agreement and Plan of Merger and Reorganization, dated as of April 10, 2024 (the Acquisition Agreement), by and among the Company, Tango Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (Transitory Subsidiary), Tenet Medicines, Inc. (Tenet), a Delaware corporation, and, solely in his capacity as Tenet equityholder representative, Stephen Thomas, providing for the acquisition of Tenet by the Company through the merger of Transitory Subsidiary into Tenet, with Tenet surviving as a wholly owned subsidiary of the Company, (ii) a Securities Purchase Agreement, dated as of April 10, 2024 (the Securities Purchase Agreement), by and among the Company and several accredited institutional investors (the PIPE Investors) including funds affiliated with RA Capital Management, L.P. (RA Capital Management), pursuant to which the Company agreed to issue and sell to the PIPE Investors in the Private Placement an aggregate of 31,238,282 shares (the PIPE Shares) of the Company’s common stock, and (iii) a registration rights agreement with the PIPE Investors, pursuant to which the Company agreed to register for resale the PIPE Shares.
On June 27, 2024, the Company completed its acquisition of Tenet in accordance with the terms of the Acquisition Agreement. Tenet was a private, development stage biotechnology company that was majority-owned by funds affiliated with RA Capital Management prior to the closing of the Acquisition. Immediately prior to the closing of the Acquisition and Private Placement, RA Capital Management beneficially owned approximately 43.9% of the Company’s outstanding common stock. The Private Placement closed immediately following the closing of the Acquisition.
The Company received aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting offering costs of $0.3 million. The offering costs were recorded as a reduction of additional paid-in capital generated in connection with the Private Placement.
Basis of Presentation
In accordance with the ASC Topic 805, Business Combinations, the Company first evaluated the initial screen test to determine if substantially all of the fair value of the gross assets acquired of Tenet was concentrated in a single asset or a group of similar assets. The Company concluded that substantially all of the fair value of the gross assets being acquired of Tenet was concentrated in the in-process research and development (IPR&D) related to the budoprutug asset. Accordingly, the Company accounted for the Acquisition as an asset acquisition.
In accordance with the asset acquisition method of accounting, the cost of the asset acquisition, which reflects the consideration transferred, (i) was allocated to the assets acquired and liabilities assumed on a relative fair value basis, (ii) no goodwill was recorded and (iii) all direct transaction costs were included in the total consideration transferred.
As illustrated further below, the amount of the consideration transferred that was allocated to the IPR&D was $51.7 million, which was expensed on the consolidated statements of operations and comprehensive loss, as the IPR&D was determined to have no future alternative use at the closing of the Acquisition.
Consideration Transferred
The fair value of the total consideration was approximately $52.8 million and was comprised of the following components (in thousands):
| Equity consideration | $41,867 |
|---|---|
| Settlement of pre-existing loan | 5,036 |
| Direct transaction costs | 5,849 |
| Total consideration | $52,752 |
Equity consideration: Based on: (i) the issuance of 5,560,047 shares of the Company’s common stock issued to the equityholders of Tenet and (ii) the closing stock price of the Company’s common stock on the Nasdaq Global Market on June 27, 2024, which was $7.53 per share.
Settlement of pre-existing loan: In May 2024, the Company and Tenet entered into a Senior Secured Promissory Note (the Note) providing for the Company to make short-term loans to Tenet up to an aggregate principal amount of $15.0 million. Pursuant to the Note, the Company made a loan (the Loan) of $5.0 million to Tenet in order to provide it with sufficient cash to fund its operations prior to the consummation of the Acquisition. The Loan included simple interest at a fixed rate per annum of 6%. Upon closing of the Acquisition, the Loan and accrued interest were eliminated in the consolidated financial statements as the preexisting relationship was effectively settled and included in consideration transferred. Further, as the carrying value of the Loan was determined to approximate fair value at the time of the Acquisition, no gain or loss was recorded upon the effective settlement.
Transaction costs: Represents the direct transaction costs, primarily legal and advisory services incurred by the Company in connection with the Acquisition.
Purchase Price Allocation
The following is the allocation of the purchase consideration for the Acquisition based on the fair value of the net assets acquired by the Company (in thousands):
| Assets acquired | |
|---|---|
| In-process research and development | $51,659 |
| Cash and cash equivalents | 1,204 |
| Prepaid expenses and other current assets | 1,861 |
| Total assets acquired | $54,724 |
| Liabilities assumed | |
| Accounts payable | (1,603) |
| Accounts payable, related party | (101) |
| Accrued expenses and other current liabilities | (192) |
| Accrued expenses, related party | (76) |
| Total liabilities assumed | $(1,972) |
| Net assets acquired | $52,752 |
- Investments
Investments consisted of available-for-sale securities as follows (in thousands):
| Amortized Cost | Unrealized Gain | Unrealized Loss | Estimated FairValue | |
|---|---|---|---|---|
| Short-term marketable securities: | ||||
| Corporate bonds | $42,200 | $18 | $(4) | $42,214 |
| U.S. Treasury securities | 26,811 | 21 | (4) | 26,828 |
| Total short-term marketable securities | $69,011 | $39 | $(8) | $69,042 |
| Long-term marketable securities: | ||||
| Corporate bonds | $59,961 | $148 | $(6) | $60,103 |
| U.S. Treasury securities | 27,068 | 120 | — | 27,188 |
| U.S. government agency debt securities | 12,499 | 2 | (9) | 12,492 |
| Total long-term marketable securities | $99,528 | $270 | $(15) | $99,783 |
| Amortized Cost | Unrealized Gain | Unrealized Loss | Estimated FairValue | |
|---|---|---|---|---|
| Short-term marketable securities: | ||||
| Corporate bonds | $33,519 | $23 | $(5) | $33,537 |
| U.S. Treasury securities | 30,130 | 27 | (4) | 30,153 |
| Total short-term marketable securities | $63,649 | $50 | $(9) | $63,690 |
| Long-term marketable securities: | ||||
| Corporate bonds | $33,982 | $16 | $(43) | $33,955 |
| U.S. Treasury securities | 24,146 | 23 | (15) | 24,154 |
| U.S. government agency debt securities | 3,500 | 1 | — | 3,501 |
| Total long-term marketable securities | $61,628 | $40 | $(58) | $61,610 |
The Company’s corporate bonds and U.S. Treasury securities, which are designated as short-term marketable securities, have a contractual maturity date that is equal to or less than one year from the respective balance sheet date.
The Company’s corporate bonds, U.S. Treasury securities, and U.S. government agency debt securities, which are designated as long-term marketable securities, have a contractual maturity date that is more than one year from the respective balance sheet date.
The unrealized losses on the Company’s available-for-sale securities as of March 31, 2025 and December 31, 2024 were not material and were caused by fluctuations in market values and interest rates as a result of the economic environment. The Company concluded that an allowance for credit losses was unnecessary as of March 31, 2025 and December 31, 2024 because the decline in the market value was attributable to changes in market conditions and not credit quality, and that it is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. There was no material realized gain or loss on available-for-sale securities in the periods presented.
The Company excludes accrued interest from both the fair value and the amortized cost basis of its available-for-sale debt securities for the purposes of identifying and measuring an impairment and to not measure an allowance for expected credit losses for accrued interest receivables. Accrued interest receivable is written off through net realized investment gains (losses) at the time the issuer of the bond defaults or is expected to default on payment. The Company presents the accrued interest receivable balance in prepaid expenses and other current assets in the unaudited condensed consolidated balance sheets. Accrued interest receivable related to marketable securities as of March 31, 2025 and December 31, 2024 was $1.3 million and $0.8 million, respectively.
Investments in a continual unrealized loss position for less than 12 months consisted of the following (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Fair Value | Fair Value | |
| Corporate bonds | $12,593 | $23,375 |
| U.S. government agency debt securities | 8,991 | — |
| U.S. Treasury securities | 6,406 | 13,079 |
| Total available-for-sale securities | $27,990 | $36,454 |
The Company did not have any investments in a continual unrealized loss position for greater than 12 months as of March 31, 2025 and December 31, 2024.
- Certain Balance Sheet Accounts
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Investment interest receivable | $1,366 | $1,119 |
| Prepaid expenses | 622 | 722 |
| Prepaid research and development deposits and expenses | 116 | 1,856 |
| Other assets | 114 | 256 |
| Total prepaid expenses and other current assets | $2,218 | $3,953 |
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Accrued research and development expenses | $3,662 | $1,237 |
| Accrued payroll expenses | 1,442 | 1,997 |
| Other accrued expenses and current liabilities | 1,000 | 835 |
| Total accrued expenses and other current liabilities | $6,104 | $4,069 |
- License Agreements
Agreements Related to Budoprutug
As a result of the Acquisition, the following legacy Tenet agreements effectively became agreements of the Company.
Acelyrin Asset Purchase Agreement
On January 11, 2024, Tenet entered into an asset purchase agreement (the Asset Purchase Agreement) with Acelyrin, Inc. (Acelyrin) and WH2, LLC, which was subsequently transferred to the Company by operation of law upon the closing of the Acquisition, providing for the acquisition of certain assets of Acelyrin related to budoprutug, including certain assigned contracts. Under these assigned contracts, the Company received worldwide license (with the right to sublicense) rights to develop, manufacture, use and commercialize budoprutug for any non-oncology indication and assumed certain liabilities of Acelyrin.
In addition, the Company inherited the rights and obligations, including financial obligations, under the CRH Agreement (as defined below) and the ProBioGen Agreement (as defined below). In consideration for the license and other rights the Company received under the Asset Purchase Agreement, the Company is obligated to (i) make total payments of up to $157.5 million to Acelyrin upon the achievement of various development, regulatory and commercial milestones, (ii) pay royalties in the single-digit percentages, subject to specified reductions, to Acelyrin on worldwide net sales in a given calendar year, and (iii) make non-refundable and non-creditable payments to Acelyrin on sublicense income with rates ranging from the low single digit to mid-teen percent depending on the stage of development of the most advanced licensed product incorporating or comprising budoprutug at the time of such sublicense.
As of March 31, 2025, the Company has not recognized milestone payments under the Asset Purchase Agreement as the underlying milestones were not achieved and are not assessed as probable.
CRH Agreement
In connection with the Asset Purchase Agreement, in January 2024 Tenet was assigned a license agreement with Cancer Research Technology Limited (CRH) and, in connection with such assignment, Tenet entered into an amended and restated license agreement with CRH (the CRH Agreement) which was subsequently transferred to the Company by operation of law upon the closing of the Acquisition. The CRH Agreement granted the Company a worldwide exclusive license (other than specified patent rights and materials, which are licensed to the Company on a non-exclusive basis) to research, develop, test, manufacture or sell certain licensed products related to budoprutug, for all therapeutic uses except for oncology indications. The Company is permitted to grant a sublicense under these licenses with CRH’s prior written consent.
The Company is obligated to pay CRH a mid-five figure digit fee on each anniversary of the effective date and up to an aggregate of £106.8 million ($138.1 million) upon the achievement of specified development, regulatory, commercial and sales milestone events, including: (i) payments of up to mid-six figure digits in pounds sterling for certain development milestones, (ii) payments of up to low-eight figures in pounds sterling per indication (for up to three indications) for certain regulatory and commercial milestones and (iii) payments up to mid-eight figures in pounds sterling for certain sales milestones. The Company is also obligated to pay tiered royalties ranging from a rate in the mid-single digit to high-single digit percentage on net sales.
The Company is also responsible for a sublicensing revenue payment ranging from a rate in the mid-single digit to mid-double digits for any sublicense revenue.
As of March 31, 2025, the Company has not recognized milestone payments under the CRH Agreement as the underlying milestones were not achieved and are not assessed as probable.
ProBioGen Agreement
Under the Asset Purchase Agreement, Tenet was assigned a cell line development, manufacturing services and license agreement (the ProBioGen Agreement) originally entered into by ValenzaBio, Inc. and ProBioGen AG (ProBioGen) in February 2021, which was subsequently transferred to the Company by operation of law upon the closing of the Acquisition.
The ProBioGen Agreement granted the Company a non-exclusive license to use cell lines in which ProBioGen’s proprietary technology is applied to research, develop, manufacture, use, sell, offer to sell, import or export budoprutug. This license includes a non-exclusive sublicense by ProBioGen of certain third-party patent rights, limited to the use of budoprutug.
The Company is obligated to (i) make payments of up to €10.0 million($10.8 million) upon the achievement of certain development, manufacturing and commercial milestones, including the start of a Phase 2 clinical trial for budoprutug, and (ii) make milestone payments of up to €7.0 million ($7.6 million) upon the achievement of certain sales milestones.
If the Company elects to contract ProBioGen to perform certain manufacturing services for budoprutug, the milestone payments would be reduced by €1.1 million ($1.1 million).
As of March 31, 2025, the Company has not recognized milestone payments under the ProBioGen Agreement as the underlying milestones were not achieved and are not assessed as probable.
Agreement Related to CLYM116
Mabworks Technology Transfer and Exclusive License Agreement
On January 8, 2025, the Company entered into the Mabworks Agreement, pursuant to which Mabworks granted to the Company (i) an exclusive (even as to Mabworks and its affiliates), sublicensable right and license under certain patent rights and related know-how (the Licensed Intellectual Property) to develop manufacture and commercialize Mabworks’ proprietary antibodies associated with Mabworks’ proprietary antibody program, CLYM116 and products containing CLYM116 (Licensed Products) outside of Greater China, (ii) a non-exclusive, sublicensable right and license under the Licensed Intellectual Property to manufacture CLYM116 and Licensed Products in Greater China (the Licensed Territory) and (iii) a non-exclusive, sublicensable right and license under the Licensed Intellectual Property to develop CLYM116 and Licensed Products in Greater China in connection with certain global clinical studies (as described below).
Under the terms of the Mabworks Agreement, the Company paid to Mabworks a $9.0 million upfront payment, and the Company is obligated to pay a total of up to $30.0 million upon the achievement of certain development and regulatory milestones pertaining to the first indication for a Licensed Product, additional lower amounts upon the achievement of certain development and regulatory milestones pertaining to up to two additional indications for a Licensed Product and a total of up to $832 million upon the achievement of certain commercial milestones for all Licensed Products. In addition, the Company is also obligated to pay Mabworks tiered royalties in the low-to mid-single-digit percentages on aggregate annual net sales of all Licensed Products in the Licensed Territory.
The Company is obligated to pay royalties on a Licensed Product-by-Licensed Product and country-by-country basis from the date of the first commercial sale in such country until the latest of: (i) the expiration of the last valid claim on the Licensed Intellectual Property covering the composition of matter of CLYM116 in such Licensed Product in such country; and (ii) ten years following the first commercial sale of such Licensed Product in such country (each, a Royalty Term).
The royalty rate is subject to reduction on a Licensed Product-by-Licensed Product and country-by-country basis under certain circumstances. In the event that the Company grants sublicenses under the Licensed Intellectual Property, the Company will be obligated to pay Mabworks a percentage, in the mid-single-digits to low-double-digits, of certain consideration received under such sublicenses.
The Company agreed to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize a Licensed Product in the U.S. The Company has also granted Mabworks a right of first refusal to develop and commercialize in the China Territory any product the Company controls that contains an antibody directed to tumor necrosis factor ligand superfamily member 13 (APRIL). Mabworks has agreed not to exploit in the Licensed Territory any product that is directed to APRIL during the term of the Mabworks Agreement. The Mabworks Agreement also contains a mechanism for the parties to collaborate on global clinical studies in the future, where the Company has a right to perform clinical studies in Greater China with Mabworks’ approval in the event that Mabworks elects not to participate in such global clinical studies.
Unless earlier terminated, the Mabworks Agreement will expire on the expiration of the last to expire Royalty Term. Either party may terminate the Mabworks Agreement for the other party’s material breach, following a customary notice and cure period, or insolvency. Additionally, the Company may terminate the Mabworks Agreement for any reason upon 60 days written notice to Mabworks.
The Mabworks Agreement was accounted for as an asset acquisition, and the upfront payment of $9.0 million and direct transaction costs of $0.1 million were included in research and development expenses in the condensed consolidated statement of operations for the three months ended March 31, 2025.
As of March 31, 2025, the Company hasnot recognized milestone payments under the Mabworks Agreement as the underlying milestones were not achieved and are not assessed as probable.
- Commitments and Contingencies
Facility Leases
The Company leases office space in the U.S. under non-cancelable operating leases.
In October 2024, the Company agreed to lease approximately 4,000 square feet of office space in Wellesley Hills, Massachusetts. The term of this lease is 24 months, which commenced on November 1, 2024.
The lease contains rent escalation clauses and an option to extend the term of the lease for an additional 12-month period at a market rate determined according to the lease. At the lease’s inception and as of March 31, 2025, the Company expects to exercise its option to extend the lease, and therefore the period covered by this option is included in the lease term.
As of March 31, 2025, the remaining lease term was 2.8 yearsand the weighted-average incremental borrowing rate used to determine the operating lease liability was 8.5%.
In November 2021, the Company agreed to lease approximately 5,000 square feet of office space in Bellevue, Washington. The term of this lease is 39 months, which commenced on November 1, 2021 and ended on January 31, 2025. In July 2023, the Company entered into a non-cancellable sublease agreement for the Bellevue office space, under the terms of which the Company is entitled to receive $0.2 million in lease payments over the term of the sublease, which commenced in July 2023 and ended concurrently with the original lease in January 2025.
For the three months ended March 31, 2025 and 2024, the Company incurred $38,000 and$0.1 million in rent expense, respectively. Sublease income was$11,000 for the three months ended March 31, 2025, which was classified as a reduction in rent expense.
As of March 31, 2025, the annual future minimum lease payments due under the Company’s non-cancelable operating leases were as follows (in thousands):
| Operating | |
|---|---|
| Year Ending December 31, | Lease Payments |
| 2025 (remaining 9 months) | $142 |
| 2026 | 194 |
| 2027 | 198 |
| Total undiscounted lease payments | $534 |
| Present value adjustment | (60) |
| Total operating lease liabilities | $474 |
Legal Proceedings
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. As of the date of these unaudited condensed consolidated financial statements, the Company is not party to any material legal matters or claims.
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless, and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has entered into indemnification agreements with its directors and officers that require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is immaterial.
- Stock-Based Compensation
2019 Plan
In 2019, the Company adopted the 2019 Equity Incentive Plan (the 2019 Plan). The 2019 Plan provided for the Company to grant qualified stock options, non-qualified stock options, and restricted stock awards to employees, non-employee directors and consultants of the Company under terms and provisions established by the Company’s board of directors. Under the terms of the 2019 Plan, options were granted at an exercise price no less than fair value of the Company’s common stock on the grant date, except in certain cases related to employees outside of the U.S. Option awards granted typically had 10-year terms measured from the option grant date. While no shares are available for future issuance under the 2019 Plan, it continues to govern outstanding equity awards granted thereunder.
2021 Plan and ESPP
The compensation committee of the Company’s board of directors adopted and the Company’s stockholders approved the 2021 Equity Incentive Plan (the 2021 Plan) and the 2021 Employee Stock Purchase Plan (the ESPP), which became effective in August 2021. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units (RSUs), stock appreciation rights and other stock-based awards. The Company’s employees, officers, directors and consultants are eligible to receive awards under the 2021 Plan. Under the terms of the 2021 Plan, options are granted at an exercise price no less than fair value of the Company’s common stock on the grant date, except in certain cases related to significant corporate transactions. Option awards granted typically have 10-year terms measured from the option grant date. As of March 31, 2025, the total number of shares authorized for issuance under the 2021 Plan was 10,148,121. Any shares that are returned under the 2019 Plan as a result of cancellation or forfeiture become available under the 2021 Plan. Further, the number of shares of common stock reserved for issuance under the 2021 Plan automatically increases on January 1 of each year, beginning on January 1, 2022, and continuing through and including January 1, 2031, by 5% of the total number of shares of common stock outstanding on December 31 of the immediately preceding calendar year, or a lesser number of shares determined by the Company’s board of directors prior to the applicable January 1st.
The ESPP allows employees, including executive officers, to contribute up to 15% of their earnings, subject to certain limitations, for the purchase of the Company’s common stock at a price per share equal to the lower of (a)85% of the fair market value of a share of common stock on the first day of the offering period, or (b)85% of the fair market value of a share of common stock on the last day of the offering period. As of March 31, 2025, there were 2,132,339 shares of common stock reserved for future issuance under the ESPP. The number of shares of common stock reserved for issuance under the ESPP will automatically increase on January 1 of each calendar year, beginning on January 1, 2022 and continuing through and including January 1, 2031, by the lesser of (1)1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year or (2) a number of shares determined by the Company’s board of directors. Shares subject to purchase rights granted under the ESPP that terminate without having been exercised in full will not reduce the number of shares available for issuance under the ESPP.
As of March 31, 2025, no shares had been granted or purchased under the ESPP.
2025 Inducement Plan
In March 2025, the Company’s board of directors adopted the 2025 Inducement Plan (the Inducement Plan), pursuant to which the Company may grant nonstatutory stock options, stock appreciation rights, restricted stock, RSUs and other stock-based awards with respect to an aggregate of 1,250,000 shares of its common stock. Awards under the Inducement Plan may only be granted to new employees who were not previously an employee or director of the Company or are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to the individual’s entering into employment with the Company in accordance with the requirements of Nasdaq Stock Market Rule 5635(c)(4). The plan was not adopted by the Company’s stockholders and will be administered by the Company’s board of directors.
As of March 31, 2025, no shares had been granted under the Inducement Plan.
Stock Options
Awards with vesting conditions under all three plans typically vest 25% on the first anniversary of the grant date with the remainder vesting monthly over the following three years.
The activity for stock options is as follows:
| Weighted | ||||
|---|---|---|---|---|
| Average | ||||
| Weighted · Remaining · Aggregate | ||||
| Average · Contract · Intrinsic | ||||
| Options | Exercise | Terms | Values | |
| Outstanding | Price | (in years) | (in thousands) | |
| Balance as of December 31, 2024 | 2,817,751 | $6.49 | 6.87 | $19 |
| Options granted | 3,009,196 | 1.80 | ||
| Options expired | (40,000) | 7.87 | ||
| Options forfeited | (225,000) | 7.58 | ||
| Balance as of March 31, 2025 | 5,561,947 | $3.90 | 8.60 | $— |
| Vested and expected to vest, March 31, 2025 | 5,561,947 | $3.90 | 8.60 | $— |
| Options exercisable as of March 31, 2025 | 804,776 | $5.86 | 2.50 | $— |
The aggregate intrinsic value disclosed in the above table is based on the difference between the exercise price of the stock option and the fair value of the Company’s common stock as of the respective period-end dates. The weighted-average grant-date fair value of stock options granted during the three months ended March 31, 2025 was $1.50 per share. There wereno grants for the three months ended March 31, 2024.
The Black-Scholes option pricing model for employee and nonemployee stock options incorporates the following assumptions:
Fair Value of Common Stock— The fair value of each share of common stock is based on the closing price of the Company’s common stock on the date of grant as reported on the Nasdaq Global Market.
Volatility— The expected stock price volatilities are estimated based on the historical and implied volatilities of comparable publicly traded companies as the Company does not have sufficient history of trading in its common stock.
Risk-free Interest Rate— The risk-free interest rates are based on US Treasury yields in effect at the grant date for notes with comparable terms as the awards.
Expected Term— The expected term represents the period that the Company’s stock options are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term).
Dividend Yield— The expected dividend yield assumption is based on the Company’s current expectations about its anticipated dividend policy.
The fair value of the Company’s stock option awards was estimated at the date of grant using a Black-Scholes option pricing model with the following assumptions for the three months ended March 31, 2025. There were no grants for the three months ended March 31, 2024.
| Three Months Ended | |
|---|---|
| March 31, 2025 | |
| Expected term (in years) | 5.77 - 6.08 |
| Expected volatility | 105.01% - 108.04 % |
| Risk-free interest rate | 4.01% - 4.66% |
| Expected dividend yield | 0.00% |
RSUs
The Company has granted: (i) RSUs that vest quarterly over a two and a half year period or vest 25% annually over a four year period and (ii) RSUs with performance-based vesting conditions.
Upon the closing of the Acquisition, the Company granted a total of 803,000 RSUs to certain consultants. Of these RSUs,401,500 are subject to service conditions, with 50% of such RSUs vesting on January 1, 2025,25% of such RSUs vesting on March 27, 2025 and the remaining 25% of such RSUs vesting on June 27, 2025. The remaining 401,500 RSUs will vest subject to the satisfaction of performance conditions, including the achievement of specific operational milestones before September 30, 2025 (Performance-Based RSUs). For the Performance-Based RSUs, no stock-based compensation expense has been recognized because the vesting conditions are not probable of being achieved.
The activity for RSUs is as follows:
| Weighted-AverageGrant-Date Fair | ||
|---|---|---|
| Number of Shares | Value | |
| Unvested at December 31, 2024 | 1,228,876 | $7.17 |
| Vested | (320,333) | 7.28 |
| Unvested at March 31, 2025 | 908,543 | $7.13 |
The fair value of restricted stock awards and RSUs vested during the three months ended March 31, 2025 and 2024 was approximately$0.5 million and $0.1 million, respectively.
Stock-Based Compensation
The following table sets forth stock-based compensation expense for stock options, restricted stock awards, and RSUs included in the Company’s condensed consolidated statements of operations and comprehensive loss (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development expense | $906 | $269 |
| General and administrative expense | 1,116 | 196 |
| Total stock-based compensation expense | $2,022 | $465 |
As of March 31, 2025, there was $12.0 million of total unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted average period of 3.4 years. Further, there was$2.8 millionof unrecognized compensation cost related to unvested RSUs, which is expected to be recognized over a weighted average period of 2.5 years.
- Net Loss Per Share
The following table shows the computation of basic and diluted net loss per share (in thousands, except share and per share data):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Net loss | $(20,781) | $(1,697) |
| Weighted-average number of shares used to compute net loss per share, basic and diluted | 67,462,450 | 27,638,528 |
| Net loss per share, basic and diluted | $(0.31) | $(0.06) |
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Common stock options | 5,561,947 | 4,261,527 |
| Unvested restricted stock awards and units | 908,543 | 188,396 |
| Total potentially dilutive shares | 6,470,490 | 4,449,923 |
- Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (the CODM). The Company views its operations and manages its business asone operating and reportable segment, focused on developing therapeutics for patients with immune-mediated diseases. The Company’s CODM is its chief executive officer.
Segment profit or loss is measured as net loss presented on the consolidated statements of operations and comprehensive loss. For the purpose of evaluating segment performance and allocating resources, the CODM reviews the Company’s financial information on a consolidated basis together with certain operating metrics and evaluates net loss against comparable prior periods and the Company’s annual operating plan. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
In addition to the significant expense categories included within net loss presented on the unaudited condensed consolidated statements of operations and comprehensive loss, the following table sets forth disaggregated research and development expenses (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Direct research and development expenses: | ||
| CLYM116 1 | $9,120 | $— |
| Budoprutug | 6,141 | — |
| Legacy and cross-program expenses 2 | 299 | 74 |
| Indirect research and development expenses: | ||
| Personnel expenses | 1,757 | 943 |
| Other research and development expenses 3 | 10 | 74 |
| Total research and development expenses | $17,327 | $1,091 |
1 Represents the upfront payment and the associated direct transaction costs incurred in connection with the Mabworks Agree ment.
2 Includes direct expenses related to the Company's legacy product candidates ETX-123 and ETX-155 and direct cross-program expenses.
3 Includes indirect expenses related to facility rent.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.