Climb Bio, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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, 2026 · Filed Nov 5, 2026
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 2026-06-30; filed 2026-08-06.
0001193125-26-336774
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-448567
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 108 previous paragraphs and 112 current paragraphs.
81 unchanged; 21 reworded; 9 added; 5 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 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 (9)
Current report
In October 2026, we presented initial data from the ongoing PrisMN Phase 2 trial, including B-cell and anti-PLA2R data from the low dose cohort (200 mg) in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026. At Week 12, the 200 mg cohort demonstrated B-cell depletion, a mean reduction in PLA2R antibody levels of 70%, and immunologic remission in five of 13 patients (38%). Patients in the 200 mg cohort with baseline PLA2R antibody levels below 175 RU/mL had a mean reduction in PLA2R antibody levels of 80% at Week 12. Phase 2 Week 12 data in the 200 mg cohort were consistent with Phase 1b Week 12 data across B-cell depletion, anti-PLA2R antibody reduction, and immunologic remission rate. A population PK analysis completed across all budoprutug studies (approximately 120) found that patients with high proteinuria (median urine protein-to-creatinine ratio (UPCR) of 6.8 g/g) clear budoprutug at least two-fold faster than non-proteinuric individuals, supporting the evaluation of higher doses in pMN. Initial data from the ongoing 600 mg cohort suggest greater drug exposure and deeper peripheral B-cell depletion compared with 200 mg, with mean peripheral CD20+ B-cell suppression at Week 4 of 98% at 600 mg compared with 74% at 200 mg. Budoprutug has been generally well tolerated in both cohorts to date, with follow-up through Week 12 for 200 mg and Week 6 for 600 mg. Enrollment in the third cohort (1000 mg) is ongoing and we expect additional data from the PrisMN Phase 2 trial from all cohorts, including longer-term follow-up in 2027.
Current report
In July 2025, we dosed the first patient in our global, open-label, dose-escalation Phase 1b clinical trial of budoprutug in moderate to severe SLE. In this trial, a single dose of budoprutug will be administered in moderate to severe SLE patients to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. As of the October 7, 2026 data cutoff, 17 participants had enrolled across the 10 mg, 30 mg and 100 mg single-dose cohorts. B-cell depletion deepened and was more durable with increasing dose, and reached a mean reduction of 84% at Week 12 in the 100 mg cohort. Reductions of greater than or equal to 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores were observed at Week 12 in 7 of 12 participants in the 30 mg and 100 mg cohorts, compared with none of the 5 in the 10 mg cohort. Budoprutug was generally well tolerated, with no serious adverse events, discontinuations due to adverse events or infusion-related reactions reported. Enrollment is ongoing in the final 200 mg cohort of the global trial.
Current report
At an R&D Spotlight Event in September 2026, we presented initial data from our Phase 1 trial and later in October 2026 at the ASN Kidney Week, we presented additional data from our Phase 1 trial, and our partner, Mabworks, presented initial healthy volunteer data from their Phase 1/2 trial. The data presented included safety, tolerability, and PK/PD. Across both studies, over 90% free APRIL suppression was sustained through 12 weeks following a single SC dose greater than or equal to 480 mg. Following a single 800 mg dose, an approximately 70% reduction in Gd-IgA1 and an approximately 60% reduction in IgA were observed at 12 weeks. PK was consistent across both studies. CLYM116 has an estimated half-life of approximately 33 days based on the 800 mg single-dose and 320 mg multiple-dose (Day 1 and Day 15) cohorts. Exposure was linear, with no target-mediated drug disposition (TMDD) observed across the effective dose range. Together, these PK and PD data support an every 12-week (Q12W) dosing regimen. CLYM116 has been generally well tolerated, with no dose limiting toxicities, treatment-related serious adverse events (SAEs), or hypogammaglobulinemia. NAVIGATE-2, the Phase 2 portion of Mabworks’ ongoing Phase 1/2 study, is a randomized, open-label study evaluating an 800 mg loading dose of CLYM116 followed by 400 mg every 8 weeks (Q8W) or Q12W, intended to support advancement of a Q12W regimen into Phase 3. The first IgAN patient was dosed in August 2026, enrollment is ongoing, and we expect initial data from this trial in the first half of 2027. We anticipate initiating a global Phase 3 trial in 2027, pending regulatory feedback.
Current report
ATM Program
Current report
Research and development expenses increased from $9.1 million for the three months ended September 30, 2025 to $11.0 million for the three months ended September 30, 2026, primarily due to $1.9 million of higher CLYM116 program costs associated with the advancement of our CLYM116 program and $0.3 million for our budoprutug program. This increase was partially offset by a $0.4 million decrease in personnel-related expenses resulting from $1.5 million of non-recurring stock-based compensation recognized in the prior-year period upon achievement of the performance conditions of certain performance-based RSUs, partially offset by increases in personnel-related expenses in the three months ended September 30, 2026 associated with increased headcount to support the continued advancement of our pipeline.
Current report
General and administrative expenses were consistent at $5.8 million for the three months ended September 30, 2026 and 2025, as higher compensation costs associated with increased headcount were fully offset by a decrease in stock-based compensation related to a non-recurring charge recognized in the prior-year period upon achievement of the performance conditions of certain performance-based RSUs.
Current report
Interest income increased from $2.0 million for the three months ended September 30, 2025 to $2.3 million for the three months ended September 30, 2026, primarily due to higher average invested balances resulting in approximately $0.6 million of additional interest income, offset by an approximately $0.3 million decrease due to lower returns earned on our marketable securities as a result of changes in interest rates.
Current report
Foreign Currency Gain (Loss)
Current report
In October 2026, we sold 1,010,000 shares of our common stock under the ATM Program at a price of $10.00 per share, resulting in gross proceeds of approximately $10.1 million.
Removed paragraphs (5)
Previous report
Target enrollment for the Phase 1b/2a trial is approximately 24 patients, which is expected to be achieved within the Phase 1b portion of the study. We expect the Phase 1b dataset will provide adequate information to inform dose selection and future development planning in ITP and other immune-mediated diseases. Future development decisions will be subject to review of the complete dataset and other considerations.
Previous report
Additionally, Mabworks anticipates dosing the first IgAN patient in the Phase 2 portion of their ongoing study in the third quarter of 2026 and we expect initial data from this trial in 2027.
Previous report
Research and development expenses increased from $6.6 million for the three months ended June 30, 2025 to $9.7 million for the three months ended June 30, 2026. The increase was primarily due to the increased spend associated with the advancement of our budoprutug and CLYM116 programs as well as increased personnel-related expenses to support such advancement.
Previous report
General and administrative expenses increased from $9.8 million for the six months ended June 30, 2025 to $11.5 million for the six months ended June 30, 2026. The increase was primarily due to higher personnel-related expenses of $1.8 million, including increased stock-based compensation of $0.6 million, driven by increased headcount.
Previous report
Foreign Currency (Loss)
Reworded paragraphs (21)
Previous wording
In November 2025, we dosed the first patient in our Phase 2 clinical trial of budoprutug in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAAS) inhibition, known as PrisMN. PrisMN, an open-label, dose-ranging Phase 2 clinical trial, is designed to further evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) (including B cells, anti-PLA2R (Phospholipase A2 Receptor) and total immunoglobulin), and preliminary efficacy, including complete and partial remission, and to identify an optimal dose for Phase 3. The FDA granted budoprutug orphan-drug designation for the treatment of pMN in January 2023 and Fast Track Designation for pMN in April 2026. Enrollment is now ongoing in the second cohort (600 mg) of the PrisMN trial, and we expect to have initial data, including B-cell and anti-PLA2R data from the low dose cohort (200 mg at 12-24 weeks) at a medical meeting in the fourth quarter of 2026.
Current wording
In November 2025, we dosed the first patient in our Phase 2 clinical trial of budoprutug in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAAS) inhibition, known as PrisMN. PrisMN, an open-label, dose-escalation Phase 2 clinical trial, is designed to further evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) (including B cells, anti-PLA2R (Phospholipase A2 Receptor) and total immunoglobulin), and preliminary efficacy, including complete and partial remission, and to identify an optimal dose for Phase 3. The FDA granted budoprutug orphan-drug designation for the treatment of pMN in January 2023 and Fast Track Designation for pMN in April 2026.
Previous wording
In June 2025, we dosed the first patient in our open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP, which is designed to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B-cell depletion and platelet counts. 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.
Current wording
In June 2025, we dosed the first patient in our open-label, dose-escalation Phase 1b clinical trial of budoprutug in patients with ITP, which is designed to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B-cell depletion and platelet counts. 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.
Previous wording
In June 2026, we presented initial Phase 1b data in patients with primary ITP at the European Hematology Association, which demonstrated an encouraging safety and tolerability profile, robust B-cell depletion, and meaningful platelet responses in heavily pretreated patients. Initial safety and efficacy data were reported from the 250 mg cohort, while initial safety data were reported from the 500 mg cohort. These findings support the continued development of budoprutug across multiple autoimmune indications. Enrollment in the 1000 mg cohort is near complete and we expect to report additional data from the 500 mg and 1000 mg dose cohorts in the fourth quarter of 2026.
Current wording
In June 2026, we presented initial Phase 1b data in patients with primary ITP at the European Hematology Association, which demonstrated an encouraging safety and tolerability profile, robust B-cell depletion, and meaningful platelet responses in heavily pretreated patients. Initial safety and efficacy data were reported from the 250 mg cohort, while initial safety data were reported from the 500 mg cohort. These findings support the continued development of budoprutug across multiple autoimmune indications. Enrollment is complete and we will present additional data from the ongoing Phase 1b trial, including from the 500 mg and 1000 mg dose cohorts at the American Society of Hematology (ASH) Annual Meeting in December 2026.
Previous wording
In July 2025, we dosed the first patient in our global, open-label, dose-escalation Phase 1b clinical trial of budoprutug in moderate to severe SLE. In this trial, a single dose of budoprutug will be administered in moderate to severe SLE patients to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. Enrollment is ongoing and we expect to have initial B-cell data from the global Phase 1b clinical trial in SLE in the fourth quarter of 2026. In December 2025, we received clearance of our IND to initiate a separate, parallel Phase 1b/2a clinical trial in SLE patients in China, which will complement our ongoing global Phase 1b clinical trial and also seek to enroll SLE patients who have lupus nephritis (LN). We dosed the first patient in this trial in June 2026 and are actively enrolling. The data from these trials in SLE are expected to provide insights into budoprutug activity and will also help to inform future development efforts for our program broadly.
Current wording
In December 2025, we received clearance of our IND to initiate a separate, parallel Phase 1b/2a clinical trial in SLE patients in China, which will complement our ongoing global Phase 1b clinical trial and also seek to enroll SLE patients who have lupus nephritis (LN). We dosed the first patient in this trial in June 2026 and are actively enrolling. These trials in SLE are expected to provide insights into budoprutug activity and will also help to inform future development efforts for our program broadly. We expect additional data from both ongoing SLE trials in 2027.
Previous wording
In parallel, we are advancing a high-concentration subcutaneous (SC) formulation of budoprutug, which may offer a differentiated convenience profile and potential commercial advantage. We completed a Phase 1 clinical trial of the SC formulation of budoprutug in healthy volunteers in Australia and announced topline data from this trial in May 2026. The SC formulation of budoprutug was generally well-tolerated and resulted in robust B-cell depletion, which was similar to the IV formulation at a matched dose. The results support the advancement of the SC formulation to a multiple dose study in autoimmune disease patients to evaluate full B-cell depleting doses and optimal dosing regimen. We expect initial data from this trial in 2027.
Current wording
In parallel, we are advancing a high-concentration subcutaneous (SC) formulation of budoprutug, which may offer a differentiated convenience profile and potential commercial advantage. We completed a Phase 1 clinical trial of the SC formulation of budoprutug in healthy volunteers in Australia and announced topline data from this trial in May 2026. The SC formulation of budoprutug was generally well-tolerated and resulted in robust B-cell depletion, which was similar to the IV formulation at a matched dose. The results support the advancement of the SC formulation to a multiple dose study in autoimmune disease patients to evaluate full B-cell depleting doses and optimal dosing regimen. We plan to initiate this study and expect initial data in 2027.
Previous wording
In December 2025, we dosed the first subject in our Phase 1 clinical trial in healthy volunteers designed to evaluate the safety, tolerability, PK, and PD of CLYM116. Separately, in February 2026, our partner, Mabworks, initiated a Phase 1/2 clinical trial in China in healthy volunteers and IgAN patients and enrollment is ongoing. In June 2026, we completed dosing in our Phase 1 trial and presented positive translational pharmacometrics modeling and initial Phase 1 safety data for CLYM116 at European Renal Association Congress. We anticipate reporting PK and PD data from our Phase 1 study in healthy volunteers at our next R&D Spotlight on September 3, 2026, and expect additional Phase 1 updates from us and our partner, Mabworks at a medical meeting later this year.
Current wording
In December 2025, we dosed the first subject in our Phase 1 clinical trial in healthy volunteers designed to evaluate the safety, tolerability, PK, and PD of CLYM116. Separately, in February 2026, our partner, Mabworks, initiated a Phase 1/2 clinical trial in China in healthy volunteers and IgAN patients and enrollment is ongoing. In June 2026, we completed dosing in our Phase 1 trial and presented positive translational pharmacometrics modeling and initial Phase 1 safety data for CLYM116 at European Renal Association Congress.
Previous wording
Cash, cash equivalents, and marketable securities were $239.2 million as of June 30, 2026. Based on our current operating plan, we expect this balance to fund operations into the second half of 2028. We have based our current estimate on assumptions that may prove to be wrong and that may change following our evaluation of our operating plan. 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. See “—Liquidity and Capital Resources.”
Current wording
Cash, cash equivalents, and marketable securities were $227.6 million as of September 30, 2026. Based on our current operating plan, we expect this balance to fund operations into the second half of 2028. We have based our current estimate on assumptions that may prove to be wrong and that may change following our evaluation of our operating plan. 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. See “—Liquidity and Capital Resources.”
Previous wording
The following table sets forth our results of operations for the three and six months ended June 30, 2026 and 2025(in thousands):
Current wording
The following table sets forth our results of operations for the three and nine months ended September 30, 2026 and 2025(in thousands):
Previous wording
The following table sets forth our research and development expenses for the three and six months ended June 30, 2026 and 2025(in thousands):
Current wording
The following table sets forth our research and development expenses for the three and nine months ended September 30, 2026 and 2025(in thousands):
Previous wording
Research and development expenses decreased from $23.9 million for the six months ended June 30, 2025 to $19.1 million for the six months ended June 30, 2026. The decrease was primarily due to the $9.0 million upfront payment and associated transaction costs made during the six months ended June 30, 2025 in connection with the Mabworks Agreement and our license of CLYM116 with no similar payment made during the six months ended June 30, 2026, partially offset by approximately $2.7 million of spend associated with the advancement of our clinical and preclinical pipeline as well as an additional $1.5 million in personnel-related expenses incurred during the six months ended June 30, 2026.
Current wording
Research and development expenses decreased from $33.0 million for the nine months ended September 30, 2025 to $30.1 million for the nine months ended September 30, 2026. The decrease was primarily due to the $9.0 million upfront payment and associated transaction costs made during the nine months ended September 30, 2025 in connection with the Mabworks Agreement and our license of CLYM116 with no similar payment made during the nine months ended September 30, 2026, partially offset by approximately $4.6 million of increased spend associated with the advancement of our pipeline as well as an additional $1.1 million in personnel-related expenses driven by increased headcount to support the continued advancement of our pipeline.
Previous wording
General and administrative expenses increased from $4.1 million for the three months ended June 30, 2025 to $5.6 million for the three months ended June 30, 2026. The increase was primarily due to higher personnel-related expenses of $1.5 million, including increased stock-based compensation of $0.7 million, driven by increased headcount.
Current wording
General and administrative expenses increased from $15.6 million for the nine months ended September 30, 2025 to $17.3 million for the nine months ended September 30, 2026, primarily due to a $1.6 million increase in personnel-related expenses driven by increased headcount.
Previous wording
Interest income decreased from $2.2 million for the three months ended June 30, 2025 to $1.9 million for the three months ended June 30, 2026, primarily due to lower returns earned on our marketable securities.
Current wording
Interest income decreased from $6.5 million for the nine months ended September 30, 2025 to $5.7 million for the nine months ended September 30, 2026, primarily due to lower returns earned on our marketable securities as a result of the changes in interest rates.
Previous wording
Foreign currency (loss) was not material in either of the three and six months ended June 30, 2026 or 2025.
Current wording
Foreign currency gain (loss) was not material in either of the three and nine months ended September 30, 2026 or 2025.
Previous wording
Since our inception, we have primarily funded our operations with proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our IPO, the sale and issuance of shares of our common stock and pre-funded warrants to purchase shares of our common stock in private placements including the 2026 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 June 30, 2026, we had cash, cash equivalents and marketable securities of $239.2 million.
Current wording
Since our inception, we have primarily funded our operations with proceeds from the sale and issuance of shares of our redeemable convertible preferred stock, our IPO, the sale and issuance of shares of our common stock and pre-funded warrants to purchase shares of our common stock in private placements including the 2026 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, 2026, we had cash, cash equivalents and marketable securities of $227.6 million.
Previous wording
For the six months ended June 30, 2026, net cash used in operating activities was $24.9 million, reflects our net loss of $27.2 million, non-cash adjustments totaling $2.5 million and a net change of $(0.2) million in our net operating assets and liabilities. Non-cash adjustments primarily related to stock-based compensation expense of $3.1 million, partially offset by net accretion of discounts on marketable securities of $0.7 million.
Current wording
For the nine months ended September 30, 2026, net cash used in operating activities was $36.9 million, which reflects our net loss of $41.8 million, non-cash adjustments totaling $4.5 million and a net change of $0.3 million in our net operating assets and liabilities. Non-cash adjustments primarily related to stock-based compensation expense of $5.1 million, partially offset by net accretion of discounts on marketable securities of $1.2 million.
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. 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, 2026, net cash used in investing activities was $70.2 million, consisting primarily of purchases of $127.5 million of marketable securities, offset by $57.5 million in proceeds received from maturities of marketable securities.
Current wording
For the nine months ended September 30, 2026, net cash used in investing activities was $63.8 million, consisting primarily of purchases of $164.3 million of marketable securities, offset by $101.5 million in proceeds received from maturities of marketable securities.
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, 2026, net cash provided by financing activities was $103.7 million, consisting primarily of net proceeds related to the 2026 Private Placement of $103.4 million.
Current wording
For the nine months ended September 30, 2026, net cash provided by financing activities was $104.9 million, consisting primarily of net proceeds related to the 2026 Private Placement of $103.4 million.
Previous wording
For the six months ended June 30, 2025, there were no financing activities.
Current wording
For the nine months ended September 30, 2025, there were no financing activities.
Previous wording
Cash, cash equivalents, and marketable securities were $239.2 million as of June 30, 2026. Based on our current operating plan, we expect this balance to fund operations into the second half of 2028. We have based our current estimate on assumptions that may prove to be wrong and that may change following our evaluation of our operating plan. We could exhaust our available capital resources sooner than we expect. 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 wording
Cash, cash equivalents, and marketable securities were $227.6 million as of September 30, 2026. Based on our current operating plan, we expect this balance to fund operations into the second half of 2028. We have based our current estimate on assumptions that may prove to be wrong and that may change following our evaluation of our operating plan. We could exhaust our available capital resources sooner than we expect. 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In June 2026, we entered into an Open Market Sale Agreement℠ with Jefferies LLC, as sales agent, to provide for the issuance and sale of up to $100.0 million of our common stock from time to time in “at-the-market” offerings (the ATM Program). In October 2026, we sold 1,010,000 shares of our common stock under the ATM Program, resulting in gross proceeds of approximately $10.1 million.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Interest income decreased from $4.5 million for the six months ended June 30, 2025 to $3.4 million for the six months ended June 30, 2026, primarily due to lower returns earned on our marketable securities.