Climb Bio, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
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.
Sep 30, 2025 · Filed Nov 6, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-106916
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-268086
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 98 previous paragraphs and 102 current paragraphs.
62 unchanged; 32 reworded; 7 added; 3 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 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 (7)
Current report
Separately, in March 2025, we received clearance from the FDA for our IND application to initiate an open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts. We have also received regulatory clearance for this trial in multiple countries outside the United States, and we continue to activate sites and enroll and dose patients. Results from this trial are expected to provide a deeper understanding of budoprutug activity and dosing and will inform future development efforts in ITP and other immune-mediated diseases. We expect to have initial data, including preliminary efficacy, from the Phase 1b/2a clinical trial in ITP in the second half of 2026.
Current report
In October 2024, we received clearance from the FDA for our IND application to initiate an open-label, dose-escalation Phase 1b clinical trial of budoprutug in patients with SLE to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. We have also received regulatory clearance for this trial in multiple countries outside the United States, and we continue to activate sites and enroll and dose patients. Results from this trial are expected to provide insights into budoprutug activity after a single intravenous dose and will also inform future development efforts for the program broadly. We expect to have initial data, including preliminary efficacy, from the Phase 1b clinical trial in SLE in the second half of 2026.
Current report
Acquired In-Process Research and Development, Related Party
Current report
General and administrative expenses increased by $0.3 million from $5.5 million for the three months ended September 30, 2024 to $5.8 million for the three months ended September 30, 2025. The increase was due primarily to higher personnel-related expenses of $0.8 million from increased headcount and stock-based compensation expense, partially offset by a decrease due to prior year restructuring costs. General and administrative expenses for the three months ended September 30, 2025 and 2024 included stock-based compensation expense of $2.2 million and $1.2 million, respectively. The increase in personnel-related expenses was partially offset by higher legal expenses in the prior year.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses increased from $8.4 million for the nine months ended September 30, 2024 to $33.0 million for the nine months ended September 30, 2025. The increase was due primarily to an increase in costs of $13.4 million for our budoprutug program, which we acquired as part of the Acquisition on June 27, 2024. The increase was driven primarily by increased costs as we advanced our clinical trials of budoprutug in pMN, ITP and SLE and increased manufacturing costs, and milestone payments under our license agreements. Costs of $9.9 million for our CLYM116 program, which we licensed in January 2025, consisted primarily of an upfront payment of $9.0 million under the Mabworks Agreement and manufacturing costs. Personnel-related expenses increased by $0.5 million due primarily to increased headcount and stock-based compensation expense, partially offset by a decrease due to prior year restructuring costs. Research and development expenses for the nine months ended September 30, 2025 and 2024 included stock-based compensation expense of $3.2 million and $2.3 million, respectively.
Current report
Acquired In-Process Research and Development, Related Party
Removed paragraphs (3)
Previous report
Research and development expenses increased from $1.0 million for the three months ended June 30, 2024 to $6.6 million for the three months ended June 30, 2025. The increase was due primarily to an increase of $4.5 million in costs incurred for our budoprutug program, which we acquired as part of the Acquisition on June 27, 2024, primarily related to clinical trial start-up and initiation activities and manufacturing. Personnel-related expenses increased by $0.6 million due to increased headcount.
Previous report
General and administrative expenses increased from $3.7 million for the three months ended June 30, 2024 to $4.1 million for the three months ended June 30, 2025. The increase was due to higher personnel-related expenses of $0.6 million from increased headcount, partially offset by higher consulting fees in the prior year in connection with the Acquisition.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Reworded paragraphs (32)
Previous wording
In March 2025, we received clearance from the 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 October 2024 and March 2025, we received clearance from the FDA for our IND applications to evaluate budoprutug in a Phase 1b clinical trial in SLE and a Phase 1b/2a clinical trial in ITP, respectively. We continue to activate sites and are enrolling and dosing patients in both trials. We also continue to pursue regulatory clearance outside of the United States for both clinical trials. Each of our 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 (SC) formulation of budoprutug, which together with the IV formulation, may provide the opportunity for a patient-tailored approach to treatment. We obtained additional non-clinical data for the SC formulation in the first half of 2025, which demonstrated high bioavailability and favorable tolerability. In August 2025, we received clearance for our clinical trial application (CTA) to initiate a Phase 1 clinical trial in healthy volunteers with the SC formulation in Australia. We anticipate initiating this trial in the coming weeks and expect to have initial clinical data in the first half of 2026.
Current wording
In March 2025, we received clearance from the 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. In October 2025, we published long-term follow-up clinical data from the previously conducted Phase 1b clinical trial, which demonstrated long-term control of proteinuria for up to three years after initial dosing in four patients who received up to four doses of budoprutug. Additionally, in three of the patients, no further immunosuppressive treatment was required. In the trial, no treatment-related adverse events grade 3 or higher were observed. Notably, the FDA has granted budoprutug orphan drug designation for the treatment of pMN. We have initiated our Phase 2 clinical trial of budoprutug in pMN (PrisMN) in multiple countries, continue to pursue regulatory clearance to open additional trial sites outside the United States and expect to dose our first patient in the coming weeks. PrisMN, an open-label, dose-ranging Phase 2 clinical trial, is designed to further evaluate safety, pharmacokinetics, pharmacodynamics (including B cells, anti-PLA2R and total immunoglobulin), and preliminary efficacy, including complete and partial remission, and identify a dose to carry forward into Phase 3.
Previous wording
In addition to budoprutug, we are also developing CLYM116, a preclinical stage anti-APRIL (A Proliferation-Inducing Ligand) mAb for patients with immunoglobulin A 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, and this ‘sweeper’ mechanism of action, 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 September 2025, and we anticipate submitting an IND or CTA for CLYM116 in IgAN in the second half of 2025.
Current wording
In addition to budoprutug, we are also developing CLYM116, an anti-APRIL (A Proliferation-Inducing Ligand) mAb for patients with immunoglobulin A 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, and this ‘sweeper’ mechanism of action, CLYM116 has the potential to enable more rapid, deep and durable inhibition of APRIL signaling. We completed IND-enabling studies for CLYM116 and reported preclinical data from a completed nonhuman primate study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody, in September 2025. The preclinical data demonstrated improvement versus sibeprenlimab, including high bioavailability, prolonged exposure, with an approximately two to three times longer half-life across doses, and deeper and more prolonged IgA reduction. Additional in vivo studies in mice showed enhanced APRIL elimination and antibody recycling relative to sibeprenlimab. In October 2025, we received clearance for our CTA to initiate a Phase 1 clinical trial in healthy volunteers with CLYM116 in Australia. We expect to dose the first subject by year-end 2025 and anticipate having initial clinical data from the Phase 1 trial in mid-2026.
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, acquiring and in-licensing 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 $8.7 million and $29.4 million for the three and six months ended June 30, 2025, respectively. We had an accumulated deficit of $259.3 million as of June 30, 2025.
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, acquiring and in-licensing 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 $12.9 million and $42.3 million for the three and nine months ended September 30, 2025, respectively. We had an accumulated deficit of $272.2 million as of September 30, 2025.
Previous wording
Since our inception, we have primarily funded our operations with net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering (IPO) of common stock, and the sale and issuance of shares in a private placement of our common stock that was completed in June 2024 in connection with the Acquisition. We do not have any products approved for sale and have not generated any revenue from product sales since our inception. Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, if approved. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities. We expect to continue to incur operating losses for the foreseeable future. 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.
Current wording
Since our inception, we have primarily funded our operations with net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our initial public offering (IPO) of common stock in 2021, and the sale and issuance of shares in a private placement of our common stock that we completed in June 2024 in connection with the Acquisition. We do not have any products approved for sale and have not generated any revenue from product sales since our inception. Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, if approved. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities. We expect to continue to incur operating losses for the foreseeable future. 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 January 8, 2025, we entered into the Mabworks Agreement 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. 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 upfront payment of $9.0 million was included in research and development expenses for the first quarter of 2025.
Current wording
On January 8, 2025, we entered into the Mabworks Agreement 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. 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 upfront payment of $9.0 million was included in research and development expenses in the first quarter of 2025.
Previous wording
Research and development expenses consist of costs incurred for our research and development activities, including preclinical studies and the development of our product candidates, budoprutug and CLYM116, and our previous product candidates, ETX-123 and ETX-155, including the following:
Current wording
Research and development expenses consist of costs incurred for our research and development activities, including development of our product candidates, budoprutug and CLYM116, and our previous product candidates, ETX-123 and ETX-155, consisting primarily of the following:
Previous wording
employee-related expenses, including salaries and related costs, and stock-based compensation expense, for employees engaged in research and development functions;
Current wording
employee-related expenses, such as salaries, bonuses, benefits, stock-based compensation, and termination benefits, for employees engaged in research and development functions;
Previous wording
the cost of third-party suppliers and manufacturers for material used in our preclinical and clinical development activities, including under agreements with contract development and manufacturing organizations (CDMOs);
Current wording
the cost of third-party suppliers and manufacturers for material used in our development activities, including under agreements with contract development and manufacturing organizations (CDMOs);
Previous wording
Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to consultants, contractors, CDMOs and CROs in connection with our preclinical and clinical development activities. We do not allocate employee costs, costs associated with facility expenses, or other indirect costs, to specific programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.
Current wording
Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to CDMOs, CROs, consultants and contractors, in connection with our preclinical and clinical development activities. We do not allocate employee costs, costs associated with facility expenses, or other indirect costs, to specific programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.
Previous wording
the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE, our planned Phase 1 clinical trial of the SC formulation of budoprutug, and any future clinical trials of our product candidates;
Current wording
the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE, our Phase 1 clinical trial of the SC formulation of budoprutug, our Phase 1 clinical trial of CLYM116, and any future clinical trials of our product candidates;
Previous wording
the potential delays in our preclinical studies, our development programs and our ongoing and planned clinical trial activities due to the effects of global events, including macroeconomic conditions and supply chain disruptions;
Current wording
the potential delays in our preclinical studies, our development programs and our clinical trial activities due to the effects of global events, including macroeconomic conditions and supply chain disruptions;
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, legal, 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.
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, legal, human resources, business development, information technology 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
Our foreign currency loss consists of foreign exchange losses resulting from remeasurement of foreign currency transactions to the U.S. Dollar.
Current wording
Our foreign currency gain (loss) consists of foreign exchange gains and losses resulting from remeasurement of foreign currency transactions to the U.S. Dollar.
Previous wording
Research and development expenses increased from $2.1 million for the six months ended June 30, 2024 to $23.9 million for the six months ended June 30, 2025. The increase was due primarily to an increase in costs of $10.6 million for our budoprutug program, which we acquired as part of the Acquisition on June 27, 2024, related to clinical trial start-up and initiation activities and manufacturing costs. Costs of $9.3 million for our CLYM116 program, which we licensed in January 2025, consisted primarily of an upfront payment of $9.0 million under the Mabworks Agreement. Personnel-related expenses increased by $1.4 million due to increased headcount.
Current wording
Research and development expenses increased from $6.2 million for the three months ended September 30, 2024 to $9.1 million for the three months ended September 30, 2025. The increase was due primarily to an increase of $2.7 million in costs incurred for our budoprutug program, which we acquired as part of the Acquisition on June 27, 2024. The increase was driven primarily by increased costs as we advanced our clinical trials of budoprutug in pMN, ITP and SLE, partially offset by lower manufacturing costs. Costs of $0.6 million for our CLYM116 program, which we licensed in January 2025, consisted primarily of manufacturing costs. Personnel-related expenses decreased by $0.9 million due primarily to prior year restructuring costs, partially offset by increased headcount.
Previous wording
Interest income increased from $2.8 million for the six months ended June 30, 2024 to $4.5 million for the six months ended June 30, 2025 due to higher invested balances in 2025 compared to 2024.
Current wording
Interest income decreased from $2.8 million for the three months ended September 30, 2024 to $2.0 million for the three months ended September 30, 2025, due primarily to lower invested balances during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024.
Previous wording
Foreign currency loss was not material in either of the three months ended June 30, 2025 or 2024.
Current wording
Foreign currency gain (loss) was not material in either of the three months ended September 30, 2025 or 2024.
Previous wording
Acquired IPR&D expense, related party was $51.7 million for the three months ended June 30, 2024. This amount represents the recognition of IPR&D expense from the Acquisition completed on June 27, 2024.
Current wording
Acquired IPR&D expense, related party was $51.7 million for the nine months ended September 30, 2024. This amount represents the recognition of IPR&D expense from the Acquisition completed on June 27, 2024.
Previous wording
General and administrative expenses increased from $5.6 million for the six months ended June 30, 2024 to $9.8 million for the six months ended June 30, 2025. The increase was primarily due to an increase in personnel-related expenses of $2.3 million from increased headcount and an increase in legal expenses of $1.2 million related to corporate matters.
Current wording
General and administrative expenses increased by $4.5 million from $11.1 million for the nine months ended September 30, 2024 to $15.6 million for the nine months ended September 30, 2025. The increase was primarily due to an increase in personnel-related expenses of $3.1 million from increased headcount and stock-based compensation expense. General and administrative expenses for the nine months ended September 30, 2025 and 2024 included stock-based compensation expense of $3.8 million and $1.6 million, respectively. Legal expenses also increased by $0.7 million.
Previous wording
Interest income increased from $1.5 million for the three months ended June 30, 2024 to $2.2 million for the three months ended June 30, 2025, due to higher invested balances in 2025 as compared to 2024.
Current wording
Interest income increased from $5.6 million for the nine months ended September 30, 2024 to $6.5 million for the nine months ended September 30, 2025 due to higher invested balances during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.
Previous wording
Foreign currency loss was not material in either of the six months ended June 30, 2025 or 2024.
Current wording
Foreign currency gain (loss) was not material in either of the nine months ended September 30, 2025 or 2024.
Previous wording
Since our inception, we have primarily funded our operations with net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our IPO of common stock and the sale and issuance of shares of our common stock in a private placement completed in June 2024 in connection with the Acquisition. 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 June 30, 2025, we had cash, cash equivalents and marketable securities of $187.4 million.
Current wording
Since our inception, we have primarily funded our operations with net proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our IPO of common stock in 2021, and the sale and issuance of shares of our common stock in a private placement we completed in June 2024 in connection with the Acquisition. 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, 2025, we had cash, cash equivalents and marketable securities of $175.8 million.
Previous wording
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 $22.4 million in an at the market offering. During the three and six months ended June 30, 2025, we did not issue and sell any shares of our common stock pursuant to the Distribution Agreement.
Current wording
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 $22.4 million in an at the market offering. During the three and nine months ended September 30, 2025, we did not issue and sell any shares of our common stock pursuant to the Distribution Agreement.
Previous wording
For the six months ended June 30, 2025, net cash used in operating activities was $26.6 million, resulting from our net loss of $29.4 million, partially offset by $1.9 million in non-cash charges and cash provided by changes in our operating assets and liabilities of $0.9 million. Cash provided by changes in our operating assets and liabilities primarily consisted of a decrease in prepaid expense and other current assets of $1.3 million and an increase in accounts payable and accrued expenses and other current liabilities of $1.1 million, partially offset by an increase in other long-term assets of $1.4 million.
Current wording
For the nine months ended September 30, 2025, net cash used in operating activities was $38.7 million, resulting from our net loss of $42.3 million and cash used by changes in our operating assets and liabilities of $1.9 million, partially offset by $5.5 million in non-cash charges. Cash used by changes in our operating assets and liabilities primarily consisted of an increase in other long-term assets of $1.5 million.
Previous wording
For the six months ended June 30, 2024, net cash used in operating activities was $2.5 million, resulting from our net loss of $56.6 million, partially offset by $52.8 million in non-cash charges, which consisted primarily of our IPR&D charge of $51.7 million and cash provided by changes in our operating assets and liabilities of $1.3 million. Cash provided by changes in our operating assets and liabilities primarily consisted of a decrease in prepaid expense and other current assets of $2.4 million, partially offset by a net decrease in accounts payable and accrued expenses and other current liabilities of $0.8 million.
Current wording
For the nine months ended September 30, 2024, net cash used in operating activities was $10.0 million, resulting from our net loss of $65.5 million, partially offset by $55.4 million in non-cash charges, which consisted primarily of our IPR&D charge of $51.7 million. Cash provided by changes in our operating assets and liabilities was not meaningful as a decrease in prepaid expense and other current assets of $1.4 million was almost entirely offset by increases in accounts payable, accrued expense amounts and operating lease liabilities.
Previous wording
For the six months ended June 30, 2025, net cash used in investing activities was $38.0 million, consisting primarily of purchases of $79.4 million of marketable securities, partially offset by $41.5 million in proceeds received from maturities of marketable securities.
Current wording
For the nine months ended September 30, 2025, net cash used in investing activities was $22.7 million, consisting primarily of purchases of $103.1 million of marketable securities, partially offset by $80.6 million in proceeds received from maturities of marketable securities.
Previous wording
For the six months ended June 30, 2024, net cash provided by investing activities was $4.1 million, consisting of $13.8 million in proceeds received from maturities of marketable securities, partially offset by the issuance of a promissory loan of $5.0 million and cash paid of $4.6 million in connection with the Acquisition.
Current wording
For the nine months ended September 30, 2024, net cash used by investing activities was $67.7 million, consisting primarily of purchases of $71.8 million of marketable securities, the issuance of a promissory loan of $5.0 million and cash paid of $4.6 million in connection with the Acquisition, partially offset by $13.8 million in proceeds received from maturities of marketable securities.
Previous wording
For the six months ended June 30, 2025, there was no financing activities.
Current wording
For the nine months ended September 30, 2025, there were no financing activities.
Previous wording
For the six months ended June 30, 2024, net cash provided by financing activities was $128.4 million, consisting of $119.7 million in proceeds received from the issuance of our common stock in the private placement completed in June 2024 in connection with the Acquisition and $8.7 million in proceeds from exercises of stock options.
Current wording
For the nine months ended September 30, 2024, net cash provided by financing activities was $130.7 million, consisting of $119.7 million in proceeds received from the issuance of our common stock in the private placement completed in June 2024 in connection with the Acquisition and $10.9 million in proceeds from exercises of stock options.
Previous wording
the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE, our planned Phase 1 clinical trial of the SC formulation of budoprutug, and any future clinical trials of our product candidates;
Current wording
the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE, our Phase 1 clinical trial of the SC formulation of budoprutug, our Phase 1 clinical trial of CLYM116, and any future clinical trials of our product candidates;
Previous wording
the potential delays in our preclinical studies, our development programs and our ongoing and planned clinical trial activities due to the effects of global events, including macroeconomic conditions and supply chain disruptions;
Current wording
the potential delays in our preclinical studies, our development programs and our clinical trial activities due to the effects of global events, including macroeconomic conditions and supply chain disruptions;
Previous 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 7 to our unaudited condensed consolidated financial statements included in this Quarterly Report for a discussion of these milestone and royalty obligations.
Current wording
We have obligations under an asset purchase agreement (the Asset Purchase Agreement) with Acelyrin, Inc. (Acelyrin) with respect to Products (as defined in the 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 7 to our unaudited condensed consolidated financial statements included in this Quarterly Report for a discussion of these milestone and royalty obligations.
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, 2024 included in our Annual Report on Form 10-K. There were no material changes to our critical accounting policies during the three or six months ended June 30, 2025.
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 or nine months ended September 30, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Each of our 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 (SC) formulation of budoprutug, which together with the IV formulation, may provide the opportunity for a patient-tailored approach to treatment. We obtained additional non-clinical data for the SC formulation in the first half of 2025, which demonstrated high bioavailability and favorable tolerability. In August 2025, we received clearance for our clinical trial application (CTA) to initiate a Phase 1 clinical trial in healthy volunteers with the SC formulation in Australia to evaluate bioavailability, pharmacokinetics, and pharmacodynamics. We are actively enrolling and dosing subjects in this trial and expect to have initial clinical data in the first half of 2026.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Acquired IPR&D expense, related party was $51.7 million for the six months ended June 30, 2024. This amount represents the recognition of IPR&D expense from the Acquisition completed on June 27, 2024.