Climb Bio, Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
CLYM$10.29+16.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0000950170-24-125294
Item 2. Management’s Discussion and Analysis of Financial Condition and Results and OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0000950170-25-070902
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 126 previous paragraphs and 107 current paragraphs.
35 unchanged; 34 reworded; 32 added; 55 removed; 2 previous and 6 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (32)
Current report
We are a clinical-stage biotechnology company committed to developing potential best-in-class therapeutics that address significant unmet need for the millions of patients living with immune-mediated diseases. We have built our pipeline by strategically acquiring or in-licensing product candidates that we believe have clear biological rationale and the potential to treat multiple indications.
Current report
We are developing our product candidates for multiple immune-mediated diseases, as summarized in the pipeline figure below.
Current report
We acquired the rights to our product candidates through license and asset purchase agreements. We have worldwide rights to develop and commercialize budoprutug for all indications, except for oncology. We have rights to develop and commercialize CLYM116 for all indications worldwide outside of mainland China, Hong Kong, Macau, and Taiwan (Greater China).
Current report
Our cornerstone product candidate, budoprutug, is a clinical-stage anti-CD19 monoclonal antibody (mAb) which has the potential to address a broad range of B-cell mediated diseases. Budoprutug is designed to deplete CD19-positive B cells, including antibody secreting cells (plasma blasts), in order to directly reduce pathogenic autoantibodies. This reduction of autoantibodies has the potential to be a disease-modifying approach in the treatment of immune-mediated diseases. We believe we are well-positioned to advance budoprutug across three distinct opportunity sets in immune-mediated disease: primarily IgG4-mediated diseases, primarily single organ IgG1-3 mediated diseases and complex systemic diseases.
Current report
We are initially developing budoprutug in lead indications representing each of these three opportunity sets, namely primary membranous nephropathy (pMN), a primarily IgG4-mediated disease, immune thrombocytopenia (ITP), a primarily single organ IgG1-3 mediated disease, and systemic lupus erythematosus (SLE), a complex systemic disease, where we believe budoprutug has the potential to be differentiated from other therapies in development and improve patient outcomes.
Current report
In March 2025, we received clearance from the U.S. Food and Drug Administration (FDA) for a Phase 2, dose range finding clinical trial of budoprutug in pMN. Budoprutug was previously evaluated in a Phase 1b clinical trial in pMN, the results of which suggest that budoprutug may offer the opportunity to induce remission of pMN in patients with moderate to severe disease. In that clinical trial, three out of five patients (60%) that received four doses of budoprutug and completed at least 48-weeks of follow-up achieved a complete remission of proteinuria, an important clinical endpoint in pMN. Notably, the FDA has granted budoprutug orphan drug designation for the treatment of pMN. We are advancing our Phase 2 clinical trial of budoprutug in pMN and anticipate dosing our first patient in the second half of 2025. Separately, in March 2025, we received clearance from the FDA for our investigational new drug (IND) application to evaluate budoprutug in a Phase 1b/2a clinical trial in ITP. In parallel, we are also pursuing regulatory clearance outside the United States for this clinical trial. We are in the process of activating sites in the Phase 1b/2a clinical trial and anticipate enrolling our first patient in the first half of 2025. Following the receipt of clearance in October 2024 from the FDA for our IND to evaluate budoprutug in a Phase 1b clinical trial in SLE, we are also pursuing regulatory clearance outside the United States for this clinical trial. We are in the process of activating sites for our Phase 1b clinical trial in SLE and anticipate enrolling our first patient in the first half of 2025. Each of these clinical trials of budoprutug in pMN, ITP and SLE will be conducted using an intravenous (IV) formulation of budoprutug. In parallel, we are advancing a subcutaneous formulation of budoprutug, which may provide the opportunity for a patient-tailored approach to treatment. We anticipate obtaining additional preclinical data for the subcutaneous formulation in the first half of 2025 and we currently plan to initiate a Phase 1 clinical trial in healthy volunteers with the subcutaneous formulation in the second half of 2025.
Current report
In addition to budoprutug, we are also developing CLYM116, a preclinical stage anti-APRIL (A Proliferation-Inducing Ligand) mAb for patients with IgA nephropathy (IgAN) and other B-cell mediated diseases. CLYM116 utilizes a novel mechanism of action to prevent APRIL signaling, potently blocking binding of APRIL to its receptors and also promoting lysosomal APRIL degradation via a pH-dependent bind-and-release design. Through its unique binding profile, CLYM116 has the potential to enable more rapid, deep and durable inhibition of APRIL signaling. We are currently evaluating CLYM116 in IND-enabling studies. We expect to report preclinical data from the program in the second half of 2025, and we anticipate submitting an IND or clinical trial application for a Phase 1 clinical trial of CLYM116 in IgAN in the second half of 2025.
Current report
Mabworks Agreement
Current report
On January 8, 2025, we 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 CLYM 116 in the territory outside of Greater China. Under the terms of the Mabworks Agreement, we made an upfront cash payment of $9.0 million to Mabworks, and we will be required to make certain additional payments upon the achievement of specified development, regulatory and commercial milestones, and to pay low- to mid-single digit tiered royalties on net sales outside of Greater China. The Mabworks Agreement was accounted for as an asset acquisition and the upfront payment was included in research and development expenses in the condensed consolidated statement of operations for the three months ended March 31, 2025.
Current report
Operating Expenses
Current report
expenses incurred under our intellectual property licenses; and
Current report
The following table sets forth our disaggregated research and development expenses (in thousands):
Current report
1 Represents the upfront payment and the associated direct transaction costs incurred in connection with the Mabworks Agreement.
Current report
2 Includes expenses related to our legacy product candidates ETX-123 and ETX-155 and direct cross-program expenses.
Current report
3 Includes indirect expenses related to facility rent.
Current report
the impact of inflationary pressures on salaries and wages, and costs of goods and transportation expenses, including the imposition of tariffs and other trade restrictions by the U.S., as well as reciprocal trade restrictions imposed by other countries (as further described Part II, Item 1A, “Risk Factors” of this Quarterly Report), among other things;
Current report
the cost of commercialization activities if budoprutug, CLYM116, or any product candidates we may develop are approved for sale, including marketing, sales and distribution costs; and
Current report
our efforts to enhance operational systems and hire personnel to support development of budoprutug, CLYM116, or any product candidates we may develop.
Current report
General and Administrative
Current report
Other Income (Expense)
Current report
Foreign Currency Loss
Current report
Operating Expenses
Current report
Research and development expenses increased from $1.1 million for the three months ended March 31, 2024 to $17.3 million for the three months ended March 31, 2025. The increase was due to (i) an increase of $15.5 million in direct research and development expenses, driven primarily by the upfront payment and the associated direct transaction costs of $9.1 million incurred in connection with the Mabworks Agreement and $6.1 million of expenses incurred during the period related to our budoprutug program and (ii) an $0.8 million increase in personnel-related expenses from increased headcount. This increase was partially offset by a $0.1 million decrease in facility rent.
Current report
General and Administrative
Current report
Other Income (Expense)
Current report
Foreign Currency Loss
Current report
In March 2025, we entered into an Equity Distribution Agreement (the Distribution Agreement) with Oppenheimer & Co. Inc., as agent (Oppenheimer), pursuant to which we may offer and sell shares of our 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, we did not issue and sell any shares of our common stock pursuant to the Distribution Agreement.
Current report
the impact of inflationary pressures on salaries and wages, and costs of goods and transportation expenses, including the imposition of tariffs and other trade restrictions by the U.S., as well as reciprocal trade restrictions imposed by other countries (as further described Part II, Item 1A, “Risk Factors” of this Quarterly Report), among other things;
Current report
the cost of commercialization activities if budoprutug, CLYM116, or any product candidates we may develop are approved for sale, including marketing, sales and distribution costs; and
Current report
our efforts to enhance operational systems and hire personnel to support development of budoprutug, CLYM116, or any product candidates we may develop.
Current report
For the three months ended March 31, 2025, net cash used in operating activities was $15.4 million. This consisted of a net loss of $20.8 million, partially offset by: (i) $1.5 million in non-cash charges primarily related to stock-based compensation expense and (ii) changes in our operating assets and liabilities that resulted in a net increase of cash of $3.9 million.
Current report
As discussed further in Note 6 in our unaudited condensed consolidated financial statements, we entered into a non-cancellable lease agreement for office space in Wellesley Hills, Massachusetts in October 2024 for a period of 24 months. As of March 31, 2025, our undiscounted future minimum lease payments under this non-cancelable lease agreement was approximately $0.5 million.
Removed paragraphs (55)
Previous report
We are a clinical-stage biotechnology company primarily focused on developing therapeutics for patients with immune-mediated diseases. Our lead product candidate, budoprutug (previously referred to as TNT119), is an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases, including primary membranous nephropathy (pMN), immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE). Budoprutug is designed to achieve broad and deep depletion of pathogenic B cells with a favorable tolerability profile and convenient dosing regimen with the potential for subcutaneous administration. We believe this reduction of autoantibodies has the potential to be disease modifying in autoantibody driven diseases, such as pMN, ITP and SLE. In a Phase 1b clinical trial of budoprutug in pMN, 3 out of 5 (or 60%) of patients that received four doses of budoprutug achieved a complete remission of proteinuria, a primary symptom of pMN, and a complete and sustained B-cell depletion was observed in all patients (5/5).
Previous report
In addition to pMN, we are also developing budoprutug for the treatment of ITP and SLE. In ITP, we believe targeting plasmablasts and plasma cells is likely to decrease the production of autoantibodies, increase platelet count and ameliorate disease. B cell depletion with anti-CD20 targeting monoclonal antibodies (mAbs) whose expression initiates somewhat later and is lost somewhat earlier than anti-CD19, has demonstrated efficacy in ITP disease for some patients in clinical trials by third parties. For those patients who do not respond to anti-CD20 therapy, we believe an anti-CD19 approach, such as budoprutug, may have the ability to further deplete pathogenic CD20-CD19+ cells. In SLE, the underlying pathology involves production of autoantibodies by autoreactive B cells that contribute to inflammation and tissue damage. CD19 is a protein expressed on the surface of these B cells and plays a key role in B cell activation. Because budoprutug is designed to target and deplete CD19-expressing B cells known to produce autoantibodies, we believe budoprutug has the potential to treat SLE.
Previous report
Based on the results of the Phase 1b clinical trial of budoprutug in pMN and clearance from the U.S. Food and Drug Administration (FDA) of our investigational new drug application (IND) for budoprutug in SLE in October 2024, we plan to initiate a Phase 1b clinical trial of budoprutug for SLE in the first half of 2025. We also plan to initiate a Phase 2 clinical trial of budoprutug for ITP in the first half of 2025, subject to clearance of an IND or clinical trial application (CTA). We are also advancing the subcutaneous formulation of budoprutug, with non-clinical data expected in the first half of 2025. We also plan to advance budoprutug into late phase clinical development for pMN in 2025.
Previous report
Below is a summary of our clinical development pipeline for budoprutug.
Previous report
On June 27, 2024, we completed our acquisition (the Acquisition) of Tenet Medicines, Inc. (Tenet). In connection with the closing of the Acquisition, we issued and sold 31,238,282 shares of our common stock at a price of $3.84 per share in a private placement (the Private Placement) to several accredited institutional investors. We received aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting offering expenses of $0.3 million.
Previous report
Recent Developments
Previous report
FDA Clearance of IND for Budoprutug in SLE
Previous report
In October 2024, the FDA cleared our IND allowing the initiation of a Phase 1b open label clinical trial of budoprutug in patients with active lupus. The clinical trial is designed to evaluate the safety and impact of ascending dose regimens on the speed and depth of depletion of circulating B cells, the decline in production of pathogenic autoantibodies, and the nature of B cell subsets that are produced upon recovery of B cells. In addition, patients will be followed for changes in clinical outcomes.
Previous report
Appointment of Director and Chair of our Board of Directors
Previous report
On November 8, 2024, our board of directors, upon the recommendation of the nominating and corporate governance committee of our board of directors, appointed Douglas E. Williams, Ph.D., as a director and the chair of our board of directors, effective immediately. Dr. Williams will serve as a director with a term expiring at the 2026 annual meeting of stockholders. Additionally, Dr. Williams has been appointed to serve as the chair of the compensation committee of our board of directors and as a member of the nominating and corporate governance committee of our board of directors, effective immediately.
Previous report
Provided Budoprutug Development Strategy and Corporate Update at Virtual Investor Event
Previous report
On October 15, 2024, we hosted a virtual investor event during which we provided an update on our development strategy for budoprutug and presented additional clinical and preclinical data.
Previous report
Strategy
Previous report
Our strategic approach to developing budoprutug will consider indications across three opportunity sets, including IgG4-mediated diseases, such as pMN; diseases caused by IgG1-3 that impact a single organ system, such as ITP; and complex systemic diseases, such as SLE. While our initial focus is on developing budoprutug for pMN, ITP and SLE, we believe that there is an opportunity to develop budoprutug for other immune-mediated diseases across both orphan and larger indications.
Previous report
Clinical Data Updates
Previous report
In October 2024, we announced additional data from the completed Phase 1b clinical trial of budoprutug for pMN. In particular, we announced the following data for the five patients who received all four doses of budoprutug in the trial:
Previous report
Three of five (60%) patients achieved complete remission of proteinuria at week 48.
Previous report
Rapid and significant reductions in anti-PLA2R autoantibodies, a key driver of pMN, with serological remission occurred in the three patients that were PLA2R-positive at baseline. Phospholipase A2 receptor (PLA2R) is a protein found in the kidney that plays a role in the development of pMN.
Previous report
Complete and sustained B-cell depletion was observed in all patients (5/5), with undetectable levels of B-cells occurring after just two doses of study drug as low as 100 mg.
Previous report
Budoprutug was generally well-tolerated at doses up to 200mg, with no reported drug-related serious adverse events. Of the eight patients who received at least one injection of budoprutug, there were no deaths on study, there were three serious adverse events none of which were considered to be related to budoprutug by the investigator, no discontinuations due to adverse events and no dose limiting toxicities were observed. Four patients reported infections on study of which three were cases of COVID-19 and one was bacterial pneumonia.
Previous report
Data from the five patients who received all four doses of budoprutug in the Phase 1b clinical trial of budoprutug for pMN is presented in the figure below.
Previous report
In October 2024, we also reported that one patient in the Phase 1b clinical trial of budoprutug for complicated minimal change disease who received two induction doses and two maintenance doses of budoprutug achieved sustained depletion of B-cells and remained in remission 18 months after the last infusion of budoprutug.
Previous report
Preclinical Data Update
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To assess whether budoprutug was capable of achieving B-cell depletion in tissues, we developed a transgenic mouse model where mouse CD19 was replaced with human CD19 in a C57BL/6 mouse. These human CD19 transgenic mice, which we refer to as huCD19 mice, were treated once weekly for four weeks with budoprutug at doses ranging from 0.1 mg/kg to 100 mg/kg. Tissue samples were taken seven days post dose and analyzed via flow cytometry for CD20+ B-cell counts in bone marrow, lymph node, and spleen. As shown in the figure below, we observed dose-dependent B-cell depletion in all tissues analyzed at day 28 with greater than 90% depletion of B-cells observed in all tissues analyzed at the highest dose tested. We believe these data lend further support to the advantages of using a CD19-targeted monoclonal antibody to deplete autoantibody secreting cells in tissues, and that this concept is translatable to humans.
Previous report
Clinical Development Plans for Budoprutug
Previous report
Based on the results of the Phase 1b clinical trial of budoprutug in pMN and clearance from the FDA of our IND for budoprutug in SLE in October 2024, we plan to initiate a Phase 1b clinical trial of budoprutug for SLE in the first half of 2025. We also plan to initiate a Phase 2 clinical trial of budoprutug for ITP in the first half of 2025, subject to clearance of an IND or CTA. We are also advancing the subcutaneous formulation of budoprutug, with non-clinical data expected in the first half of 2025. We also plan to advance budoprutug into late phase clinical development for pMN in 2025.
Previous report
pMN. Based on the results of the Phase 1b clinical trial of budoprutug in pMN, we are engaging with global regulatory agencies on the design of our late phase clinical program and plan to advance the program in 2025.
Previous report
ITP. We expect our Phase 2 clinical trial of budoprutug for ITP will be a single-arm, open-label trial evaluating budoprutug in adult patients with chronic disease who had an insufficient response to one or more prior therapies. The primary endpoints of the trial are expected to be safety and tolerability and improvement in platelet counts. Secondary endpoints are expected to include patient reported outcomes, quality of life measures, pharmacokinetics and pharmacodynamics. Patients will receive a treatment cycle at day 1 and day 15. Investigators can elect for a second cycle of treatment if improvement wanes, guided by individual patient laboratory findings and clinical needs.
Previous report
SLE. We expect our Phase 1b clinical trial of budoprutug for SLE will be an open-label, dose escalation trial in patients with active SLE that will evaluate ascending dose regimens. The primary objective of the trial will be to evaluate the safety and tolerability of budoprutug. Secondary and exploratory endpoints are expected to include clinical response, decline in pathogenic autoantibodies and assessment of B-cell subsets upon recovery.
Previous report
Subcutaneous Formulation of Budoprutug We are also developing a high concentration formulation of budoprutug to support subcutaneous administration, which is a convenient dose form that is designed to differentiate budoprutug from intravenous treatments. We have successfully formulated budoprutug to concentrations exceeding 175 mg/ml while maintaining low viscosity, creating an opportunity to pursue a subcutaneous dosing form that potentially features a low volume injection. We plan to announce non-clinical data on the subcutaneous formulation of budoprutug in the first half of 2025.
Previous report
Acquired In-Process Research and Development, Related Party
Previous report
Our acquired IPR&D expense consists of the relative fair value of the assets acquired and consideration transferred in connection with the Acquisition. As the assets acquired were in the research and development phase and were determined to not have any alternative future use, it was expensed as IPR&D.
Previous report
The direct and indirect costs research and development costs were as follows (in thousands):
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the costs of manufacturing our product candidates by third parties;
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Foreign Currency Gain (Loss)
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Research and Development and Research and Development, Related Party
Previous report
Research and development expenses increased 111.6% from $2.9 million for the three months ended September 30, 2023 to $6.1 million for the three months ended September 30, 2024. Research and development expenses, related party increased by $0.2 million for the three months ended September 30, 2024. In total, research and development expenses increased by 117.2% from $2.9 million for the three months ended September 30, 2023 to $6.3 million for the three months ended September 30, 2024. The increase was due to (i) a $2.1 million increase in personnel-related expenses, primarily driven by restructuring costs of $2.7 million, partially offset by a decrease of $0.6 million from reduced headcount, (ii) a $1.0 million increase in direct preclinical and clinical expenses related to the development of budoprutug, and (iii) a $0.3 million decrease in the U.K. refundable research and development tax credits due to the overall reduction in qualifying research and development expense.
Previous report
Foreign Currency Gain (Loss)
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Comparison of the Nine Months Ended September 30, 2024 and September 30, 2023
Previous report
Acquired In-Process Research and Development, Related Party
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Reworded paragraphs (34)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the SEC on March 28, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve substantial risks and uncertainties. As a result of many factors, including those factors set forth in Part II, Item 1A. “Risk Factors” of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. For further information regarding our forward-looking statements, see “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q (Quarterly Report) and the audited financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the SEC on March 25, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve substantial risks and uncertainties. As a result of many factors, including those factors set forth in Part II, Item 1A. “Risk Factors” of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. For further information regarding our forward-looking statements, see “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report.
Previous wording
Effective on October 2, 2024, we amended our Amended and Restated Certificate of Incorporation to effect a change of our name from “Eliem Therapeutics, Inc.” to “Climb Bio, Inc.”. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us” and “our” refer to Climb Bio, Inc. and its wholly owned subsidiaries.
Current wording
Unless the context requires otherwise, references in this Quarterly Report to “we,” “us,” and “our” refer to Climb Bio, Inc. and its wholly owned subsidiaries.
Previous wording
Previously, we focused primarily on developing novel therapies for neuronal excitability disorders to address unmet needs in psychiatry, epilepsy, chronic pain, and other disorders of the peripheral and central nervous systems, and our lead program was ETX-123, a Kv7.2/3 potassium channel opener. ETX-123 is designed to harness the efficacy of the Kv7.2/3 channel mechanism while attempting to improve the safety and tolerability relative to earlier molecules, based on our insights into the mechanisms of toxicity and the potency and selectivity profile. In July 2023, we made the determination to pause further development of our Kv7 program, and we continue to evaluate our Kv7 program, including seeking a partner for further development.
Current wording
Previously, we focused primarily on developing novel therapies for neuronal excitability disorders to address unmet needs in psychiatry, epilepsy, chronic pain, and other disorders of the peripheral and central nervous systems, and our lead program was ETX-123, a Kv7.2/3 potassium channel opener. ETX-123 was designed to harness the efficacy of the Kv7.2/3 channel mechanism while attempting to improve the safety and tolerability relative to earlier molecules, based on our insights into the mechanisms of toxicity and the potency and selectivity profile. In July 2023, we made the determination to pause further development of our Kv7 program, and we continue to evaluate our Kv7 program, including seeking a partner for further development.
Previous wording
We have incurred significant operating losses since inception, as we have devoted substantially all of our resources to organizing and staffing our company, identifying potential product candidates, business planning, raising capital, undertaking research, executing preclinical studies and clinical development trials, and providing general and administrative support for business activities. We incurred net losses of $8.9 million and $4.0 million for the three months ended September 30, 2024 and 2023, respectively, and $65.5 million and $31.5 million for the nine months ended September 30, 2024 and 2023, respectively. We had an accumulated deficit of $221.5 million and $156.0 million as of September 30, 2024 and December 31, 2023, respectively.
Current wording
We have incurred significant operating losses since inception, as we have devoted substantially all of our resources to organizing and staffing our company, identifying potential product candidates, business planning, raising capital, undertaking research, executing preclinical studies and clinical development trials, and providing general and administrative support for business activities. We incurred net losses of $20.8 million and $1.7 million for the three months ended March 31, 2025 and 2024, respectively. We had an accumulated deficit of $250.7 million and $229.9 million as of March 31, 2025 and December 31, 2024, respectively.
Previous wording
Since our inception, we have primarily funded our operations with an aggregate of $328.0 million in net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering of our common stock and the sale and issuance of shares in the Private Placement of our common stock that was completed in June 2024. We had cash, cash equivalents and marketable securities of $217.9 million and $106.8 million as of September 30, 2024 and December 31, 2023, respectively. Based on our current operating plan, we estimate that our cash, cash equivalents and marketable securities will be sufficient to fund our planned operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate, which case we would be required to obtain additional financing, which may not be available to us on acceptable terms, or at all.
Current wording
Since our inception, we have primarily funded our operations with an aggregate of $328.0 million in net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering of our common stock, and the sale and issuance of shares in a private placement of our common stock that was completed in June 2024. We had cash, cash equivalents and marketable securities of $197.8 million and $212.5 million as of March 31, 2025 and December 31, 2024, respectively. Based on our current operating plan, we estimate that our cash, cash equivalents and marketable securities will be sufficient to fund our planned operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently anticipate, in which case we would be required to obtain additional financing, which may not be available to us on acceptable terms, or at all.
Previous wording
Until such time, if ever, as we can generate significant revenue from product sales, we may finance our operations through equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. Adequate funding may not be available when needed or on terms acceptable to us, or at all. If we are unable to raise additional capital as needed, we may have to significantly delay, scale back or discontinue any future development of our product candidates. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, resulting from increased volatility in the trading prices for shares in the biopharmaceutical industry, or otherwise. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose.
Current wording
Until such time, if ever, as we can generate significant revenue from product sales, we may finance our operations through equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. Adequate funding may not be available when needed or on terms acceptable to us, or at all.
Previous wording
On June 27, 2024, we acquired 100% of the share capital of Tenet in exchange for 5,560,047 shares of our common stock, valued at $41.9 million, or $7.53 per share. The Acquisition is accounted for as an asset acquisition. The total cost of the asset acquisition was $52.8 million, which also included (i) $5.8 million of direct transaction costs incurred and (ii) $5.0 million related to a loan provided to Tenet prior to the closing of the Acquisition that was effectively settled upon the closing of the Acquisition. We recognized in-process research and development (IPR&D) expense of $51.7 million for the nine months ended September 30, 2024, as the IPR&D was determined to have no future alternative use.
Current wording
On June 27, 2024, we acquired 100% of the share capital of Tenet Medicines, Inc. (Tenet) in exchange for 5,560,047 shares of our common stock, valued at $41.9 million, or $7.53 per share (the Acquisition). The Acquisition is accounted for as an asset acquisition. The total cost of the asset acquisition was $52.8 million, which also included (i) $5.8 million of direct transaction costs incurred and (ii) $5.0 million related to a loan provided to Tenet prior to the closing of the Acquisition that was effectively settled upon the closing of the Acquisition. We recognized in-process research and development (IPR&D) expense of $51.7 million for the year ended December 31, 2024, as the IPR&D was determined to have no future alternative use.
Previous wording
Our operating expenses consist of (i) acquired IPR&D, related party, (ii) research and development expenses, and (iii) general and administrative expenses.
Current wording
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Previous wording
Our research and development expenses consist primarily of direct and indirect costs incurred in connection with our discovery efforts, preclinical studies, and clinical trial activities related to our pipeline, including budoprutug and our previous product candidates ETX-123 and ETX-155.
Current wording
Our research and development expenses consist of direct and indirect costs incurred in connection with our discovery efforts, preclinical studies, expenses incurred under our intellectual property licenses, and clinical trial activities related to our pipeline, including budoprutug, CLYM116 and our previous product candidates ETX-123 and ETX-155.
Previous wording
Our direct research and development costs include:
Current wording
Our direct research and development expenses include:
Previous wording
the cost to manufacture drug products for use in our preclinical studies and clinical trials; and
Current wording
the cost to manufacture drug products for use in our preclinical studies and clinical trials;
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Our indirect research and development costs include:
Current wording
Our indirect research and development expenses include:
Previous wording
Given our stage of development and the utilization of our resources across our current and legacy programs, we have not historically tracked our research and development costs by program or indication. Research and development expenses are presented net of refundable research and development tax credits from the U.K. government.
Current wording
Given our stage of development and the utilization of our resources across our current and legacy programs, we have not historically tracked our indirect research and development costs by program or indication.
Previous wording
We expect our research and development expenses to increase substantially for the foreseeable future as we conduct our ongoing research and development activities. The process of conducting preclinical studies, acquiring drug product supply, and conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for budoprutug or any product candidate we may develop.
Current wording
We expect our research and development expenses to increase substantially for the foreseeable future as we conduct our ongoing research and development activities. The process of conducting preclinical studies, acquiring drug product supply, and conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for budoprutug, CLYM116, or any product candidate we may develop.
Previous wording
The timelines and costs associated with research and development activities are uncertain and can vary significantly among product candidates and development programs due to the inherently unpredictable nature of preclinical and clinical development. We anticipate that we will make determinations as to which indications to pursue in connection with our clinical development of budoprutug or any product candidates we may develop and how much funding to direct to each such indication on an ongoing basis in response to preclinical and clinical results, regulatory developments, and ongoing assessments as to each such indication’s commercial potential. We will need to raise substantial additional capital in the future.
Current wording
The timelines and costs associated with research and development activities are uncertain and can vary significantly among product candidates and development programs due to the inherently unpredictable nature of preclinical and clinical development. We anticipate that we will make determinations as to which indications to pursue in connection with our clinical development of budoprutug, CLYM116, or any product candidates we may develop and how much funding to direct to each such indication on an ongoing basis in response to preclinical and clinical results, regulatory developments, and ongoing assessments as to each such indication’s commercial potential. We will need to raise substantial additional capital in the future.
Previous wording
A change in the outcome of any of these variables with respect to the development of budoprutug or any product candidates we may develop could significantly change the costs and timing associated with the development.
Current wording
A change in the outcome of any of these variables with respect to the development of budoprutug, CLYM116, or any product candidates we may develop could significantly change the costs and timing associated with the development.
Previous wording
Our general and administrative expenses consist primarily of personnel-related expenses such as salaries, bonuses, benefits, stock-based compensation, and termination benefits, for our personnel in executive, finance and accounting, human resources, business development and other administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, audit, regulatory, tax and consulting services, insurance costs, as well as investor and public relations costs.
Current wording
Our general and administrative expenses consist primarily of personnel-related expenses such as salaries, bonuses, benefits, stock-based compensation, and termination benefits, for our personnel in executive, finance and accounting, human resources, business development and other administrative functions. Other significant general and administrative expenses include legal fees relating to corporate matters and intellectual property, professional fees for accounting, audit, regulatory, tax and consulting services, insurance costs, as well as investor and public relations costs.
Previous wording
We expect that our general and administrative expenses will significantly increase in the future as we increase our headcount to support our operations.
Current wording
We expect that our general and administrative expenses will increase for the foreseeable future as we continue to increase our general and administrative headcount to support our growth strategy and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally.
Previous wording
Our foreign currency gain (loss) consists of foreign exchange losses resulting from remeasurement and foreign currency transactions between the British Pound and the U.S. Dollar.
Current wording
Our foreign currency loss consists of foreign exchange losses resulting from remeasurement and foreign currency transactions between foreign currency and the U.S. Dollar.
Previous wording
General and administrative expenses increased by 158.4% from $2.1 million for the three months ended September 30, 2023 to $5.5 million for the three months ended September 30, 2024. The increase was primarily due to due to (i) a $1.7 million increase in personnel-related expenses, largely driven by an increase of $1.3 million from increased headcount and a $0.4 million increase in restructuring costs and (ii) a $1.7 million increase in other general and administrative expenses, largely due to an increase in legal expenses and consulting fees.
Current wording
General and administrative expenses increased from $1.9 million for the three months ended March 31, 2024 to $5.7 million for the three months ended March 31, 2025. The increase was due to (i) a $2.1 million increase in other general and administrative expenses, largely due to an increase in consulting fees, legal expenses, and human resources costs and (ii) a $1.7 million increase in personnel-related expenses from increased headcount.
Previous wording
Foreign currency gain (loss) increased from a $0.2 million loss for the three months ended September 30, 2023 to a $0.1 million gain for the three months ended September 30, 2024. The increase was driven by favorable changes in foreign currency exchange rates between the British Pound and the U.S. Dollar in the three months ended September 30, 2024.
Current wording
Foreign currency loss increased from a $33,000 loss for the three months ended March 31, 2024 to a $50,000 loss for the three months ended March 31, 2025. The increase in loss was driven primarily by unfavorable changes in foreign currency exchange rates for the three months ended March 31, 2025.
Previous wording
Interest income, net increased from $1.3 million for the three months ended September 30, 2023 to $2.8 million for the three months ended September 30, 2024, which was driven by an increase in investment income from an increase in marketable securities during the three months ended September 30, 2024.
Current wording
Interest income, net increased from $1.3 million for the three months ended March 31, 2024 to $2.3 million for the three months ended March 31, 2025, which was driven by an increase in investment income due to an increase in marketable securities in the current period.
Previous wording
Since our inception, we have primarily funded our operations with an aggregate of $328.0 million in net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering of our common stock and the sale and issuance of shares of our common stock in the Private Placement. We have not generated any revenue from product sales or otherwise. We have incurred net losses from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. As of September 30, 2024 and December 31, 2023, we had cash, cash equivalents and marketable securities of $217.9 million and $106.8 million, respectively, and an accumulated deficit of $221.5 million and $156.0 million, respectively.
Current wording
Since our inception, we have primarily funded our operations with an aggregate of $328.0 million in net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering of our common stock and the sale and issuance of shares of our common stock in a private placement in June 2024. We have not generated any revenue from product sales or otherwise. We have incurred net losses from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. As of March 31, 2025 and December 31, 2024, we had cash, cash equivalents and marketable securities of $197.8 million and $212.5 million, respectively, and an accumulated deficit of $250.7 million and $229.9 million, respectively.
Previous wording
We believe our cash, cash equivalents and marketable securities of $217.9 million as of September 30, 2024 will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
We believe our cash, cash equivalents and marketable securities of $197.8 million as of March 31, 2025 will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Previous wording
We anticipate that our expenses will increase for the foreseeable future as we continue to advance budoprutugand any product candidates we may develop, expand our corporate infrastructure, and incur costs associated with potential commercialization. We are subject to all of the risks typically related to the development of biopharmaceutical candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
Current wording
We are subject to all of the risks typically related to the development of biopharmaceutical candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
Previous wording
Until such time, if ever, as we can generate substantial revenue from product sales, we may finance our operations through equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or budoprutug, or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts, or grant rights to develop and market budoprutug or any product candidates we may develop even if we would otherwise prefer to develop and market such product candidates ourselves.
Current wording
Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or our product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts, or grant rights to develop and market budoprutug, CLYM116, orany product candidates we may develop even if we would otherwise prefer to develop and market such product candidates ourselves.
Previous wording
The following table summarizes our cash flows (in thousands):
Current wording
The following table sets forth our cash flows (in thousands):
Previous wording
For the nine months ended September 30, 2024, net cash used in operating activities was $10.0 million. This consisted primarily of a net loss of $65.5 million, partially offset by total non-cash adjustments of $55.5 million that primarily related to IPR&D and stock-based compensation expense.
Current wording
For the three months ended March 31, 2024, net cash used in operating activities was $1.8 million. This consisted primarily of a net loss of $1.7 million and changes in our operating assets and liabilities that resulted in a net decrease in cash of $0.6 million. The decrease in cash was partially offset by total non-cash adjustments of $0.5 million that primarily related to stock-based compensation expense.
Previous wording
For the nine months ended September 30, 2023, net cash provided by investing activities was $32.2 million. This consisted of $90.7 million in proceeds received from maturities of marketable securities, primarily offset by purchases of $58.4 million of marketable securities.
Current wording
For the three months ended March 31, 2025, net cash used in investing activities was $42.8 million. This consisted of purchases of $58.8 million of marketable securities, partially offset by $16.0 million in proceeds received from maturities of marketable securities.
Previous wording
Following the Acquisition, we have obligations under an asset purchase agreement and certain license agreements that obligate us to make specified milestone and royalty payments. The payment obligations under these agreements are contingent upon future events, such as our achievement of specified development, regulatory and commercial milestones, or generating product sales. We are unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. See Note 6 in our condensed consolidated financial statements included herein for a discussion of these milestone and royalty obligations.
Current wording
We have obligations under an asset purchase agreement and certain license agreements that obligate us to make specified milestone and royalty payments. The payment obligations under these agreements are contingent upon future events, such as our achievement of specified development, regulatory and commercial milestones, or generating product sales. We are unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. See Note 5 to our unaudited condensed consolidated financial statements included in this Quarterly Report for a discussion of these milestone and royalty obligations.
Previous wording
This management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of our condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and notes to the condensed consolidated financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions and conditions.
Current wording
This management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of our unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and notes to the unaudited condensed consolidated financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions and conditions.
Previous wording
A summary of our critical accounting policies is presented in our audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 included in our Annual Report on Form 10-K. There were no other material changes to our critical accounting policies during the nine months ended September 30, 2024.
Current wording
A summary of our critical accounting policies is presented in our audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2024 included in our Annual Report on Form 10-K. There were no material changes to our critical accounting policies during the three months ended March 31, 2025.
Previous wording
See Note 1 in our condensed consolidated financial statements included herein and see Note 2 to our annual consolidated financial statements included in our Annual Report on Form 10-K.
Current wording
See Note 1 to our unaudited condensed consolidated financial statements included in this Quarterly Report and see Note 2 to our annual consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited consolidated financial statements in a registration statement for an initial public offering (IPO), an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to the Sarbanes-Oxley Act, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We have elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) we are no longer an emerging growth company or (ii) we affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
Current wording
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued after the enactment of the JOBS Act until those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited consolidated financial statements in a registration statement for an initial public offering, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to the Sarbanes-Oxley Act, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We have elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) we are no longer an emerging growth company or (ii) we affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
If we are unable to raise additional capital as needed, we may have to significantly delay, scale back or discontinue any future development of our product candidates. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, resulting from increased volatility in the trading prices for shares in the biopharmaceutical industry, or otherwise. Further, imposition of tariffs and other trade restrictions by the U.S., as well as reciprocal trade restrictions imposed by other countries, could adversely affect global economies, financial markets and the overall environment in which we do business, as further described in Part II, Item 1A, “Risk Factors” of this Quarterly Report.
Current report — wording carried from elsewhere
If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Current report — wording carried from elsewhere
Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose.
Current report — wording carried from elsewhere
We anticipate that our expenses will increase for the foreseeable future as we continue to advance our current product candidatesand any product candidates we may develop, expand our corporate infrastructure, and incur costs associated with potential commercialization.
Current report — wording carried from elsewhere
Furthermore, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. Until such time, if ever, as we can generate substantial revenue from product sales, we may finance our operations through equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.
Current report — wording carried from elsewhere
For the three months ended March 31, 2024, net cash provided by investing activities was $13.8 million, which consisted of proceeds received from maturities of marketable securities.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The following table sets forth our results of operations (in thousands):
Previous report — wording carried elsewhere
Furthermore, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures.