Corbus Pharmaceuticals Holdings, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 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 12, 2025
CRBP$3.07+7.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0000950170-25-103118
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277748
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 77 previous paragraphs and 81 current paragraphs.
50 unchanged; 22 reworded; 9 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 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
Recent Developments
Current report
On May 31, 2023, the Company entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the "Open Market Sale Agreement") with Jefferies LLC ("Jefferies"), as sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million. During the three and nine months ended September 30, 2025, we sold an aggregate of 272,938 shares of common stock, under the Open Market Sale Agreement, for net proceeds of approximately $2.9 million. From October 1, 2025 through the date of filing, the Company has sold approximately 232,279 shares of its common stock pursuant to the Open Market Sale Agreement for which the Company received net proceeds of approximately $3.6 million.
Current report
2025 Public Offering
Current report
On October 30, 2025, the Company entered into an underwriting agreement with Jefferies, as representative of the several underwriters, relating to an underwritten public offering of 4,744,231 shares of the Company’s common stock, par value $0.0001, at a price to the public of $13.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,025,000 shares of common stock at a public offering price of $12.9999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. The underwriters were also granted a 30-day option to purchase up to an additional 865,384 shares of common stock at the public offering price. On November 3, 2025, the Company completed the public offering raising gross proceeds of approximately $75.0 million and net proceeds of approximately $70.2 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
Current report
Research and development expenses for the three months ended September 30, 2025 totaled approximately $20.9 million, an increase of $10.1 million from approximately $10.8 million recorded for the three months ended September 30, 2024.
Current report
Comparison of Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses for the nine months ended September 30, 2025 totaled approximately $51.7 million, an increase of $28.3 million from approximately $23.4 million recorded for the nine months ended September 30, 2024.
Current report
Cash provided by financing activities for the nine months ended September 30, 2025 totaled approximately $2.9 million, which was related to the issuance of common stock. For the nine months ended September 30, 2025, we sold an aggregate of 272,938 shares of common stock under the Open Market Sale Agreement for net proceeds of approximately $2.9 million.
Current report
Based on current operating plans and assumptions regarding clinical timelines and other planned expenditures, we expect our cash, cash equivalents, and investments of approximately $104.0 million at September 30, 2025, together with net proceeds of $73.8 million raised from the sale of our common stock under the Open Market Sales Agreement and the 2025 Public Offering, will be sufficient to meet our operating and capital requirements through at least twelve months from the issuance of this Quarterly Report on Form 10-Q.
Removed paragraphs (5)
Previous report
Research and development expenses for the three months ended June 30, 2025 totaled approximately $15.2 million, an increase of $8.3 million from approximately $6.9 million recorded for the three months ended June 30, 2024.
Previous report
Comparison of Six Months Ended June 30, 2025 and 2024
Previous report
Research and development expenses for the six months ended June 30, 2025 totaled approximately $30.8 million, an increase of $18.2 million from approximately $12.6 million recorded for the six months ended June 30, 2024.
Previous report
No cash was provided by financing activities for the six months ended June 30, 2025.
Previous report
Based on our current planned operations and our cash, cash equivalents, and investments of approximately $116.6 million at June 30, 2025, we expect to have sufficient funds to meet our operating and capital requirements to support our operations through the second quarter of 2027.
Reworded paragraphs (22)
Previous wording
CRB-701 is a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of MMAE. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States ("U.S."), Canada, the European Union (including the European Free Trade Area), the United Kingdom ("U.K.") and Australia. CRB-701 (SYS6002) is currently being investigated by CSPC in a Phase 1/2 clinical trial in participants with advanced solid tumors in China (the "China study"). We commenced a corresponding Phase 1/2 study in the U.S. and the U.K. (the "Western study") in April 2024 and completed enrollment of the dose escalation phase in October 2024. Both studies are enrolling participants with advanced solid tumors associated with Nectin-4 expression. Subsequent to the completion of enrollment in the dose escalation phase, we began enrolling the dose optimization portion of the Western study, added additional clinical sites in Europe, and in June 2025 began dosing participants in the PD-1 combination arm with CRB-701 in combination with Keytruda® (pembrolizumab). We expect to present the dose expansion data at the European Society for Medical Oncology ("ESMO") in October 2025, which will include data from over 100 participants from the U.S. and Europe with head and neck squamous cell carcinoma ("HNSCC"), cervical and urothelial ("mUC") tumors. We further expect to complete the dose optimization phase and identify the recommended Phase 2 dose ("RP2D") in the fourth quarter of 2025.
Current wording
CRB-701 is a next-generation ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of MMAE. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. ("CSPC"), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States ("U.S."), Canada, the European Union (including the European Free Trade Area), the United Kingdom ("U.K.") and Australia. CRB-701 (SYS6002) is currently being investigated by CSPC in a Phase 1/2 clinical trial in participants with advanced solid tumors in China (the "China study"). We commenced a corresponding Phase 1/2 study in the U.S. and the U.K. (the "Western study") in April 2024 and completed enrollment of the dose escalation phase in October 2024. Both studies are enrolling participants with advanced solid tumors associated with Nectin-4 expression. Subsequent to the completion of enrollment in the dose escalation phase, we began enrolling the dose optimization portion of the Western study, added additional clinical sites in Europe, and in June 2025 began dosing participants in the PD-1 combination arm with CRB-701 in combination with Keytruda® (pembrolizumab). We presented the dose optimization data at the European Society for Medical Oncology ("ESMO") in October 2025. Data as of September 1, 2025 was presented from 167 patients, of whom 122 were evaluable for efficacy, from the U.S. and Europe with head and neck squamous cell carcinoma ("HNSCC"), cervical, locally advanced/metastatic urothelial ("mUC") tumors and other solid-tumor types. We expect to engage and consult with the FDA regarding the design of a registrational study and anticipate commencing this study by mid-2026.
Previous wording
CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. Pre-clinical data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for participants with solid tumors in combination with existing therapies, including checkpoint inhibitors. The first participant in a Phase 1 dose escalation study was dosed in December 2024 under an open IND and regulatory approval for the study was received in the U.K. in January 2025. Dose escalation in combination with Keytruda® (pembrolizumab) commenced in June 2025. We expect to report dose escalation data in the fourth quarter of 2025.
Current wording
CRB-601 is a potent and selective anti-αvβ8 monoclonal antibody that blocks the activation of latent TGFβ found on cancer cells. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with an anti-PD-1 checkpoint inhibitor compared to each single agent on its own. Pre-clinical data suggests that blockade of latent TGFβ production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, thus potentially enhancing the benefit of PD-1 blockade. CRB-601 is being developed as a potential treatment for participants with solid tumors in combination with existing therapies, including checkpoint inhibitors. The first participant in a Phase 1 dose escalation study was dosed in December 2024 under an open IND and regulatory approval for the study was received in the U.K. in January 2025. Dose escalation in combination with Keytruda® (pembrolizumab) commenced in June 2025. In November 2025, we presented a study-in-progress poster at the 2025 Society for Immunotherapy of Cancer ("SITC") conference and dose escalation is on-going.
Previous wording
CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We dosed the first participant in the single ascending dose ("SAD") portion of a Phase 1 study in the first quarter of 2025 and thus far have observed an absence of treatment-related neuropsychiatric events. In June 2025, we dosed the first participant in the multiple ascending dose ("MAD") portion of the Phase 1 trial, which is scheduled for completion in the third quarter of 2025. The initiation of a Phase 1b dose-range finding study in obese non-diabetic individuals is expected to begin in the fourth quarter of 2025. CB1 inverse agonism is a clinically validated mechanism known to induce weight loss; however, neuropsychiatric adverse events have been reported in prior clinical studies with both rimonabant and monlunabant. CRB-913 has been specifically formulated to shift the drug exposure from the brain to the periphery to improve safety and tolerability. The drug was shown in pre-clinical studies to have a brain to plasma ratio fifty times lower than rimonabant and fifteen times more peripherally restricted than monlunabant.
Current wording
CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We dosed the first participant in the single ascending dose ("SAD") portion of a Phase 1 study in the first quarter of 2025 and thus far have observed an absence of treatment-related neuropsychiatric events. In June 2025, we dosed the first participant in the multiple ascending dose ("MAD") portion of the Phase 1 trial. We expect to report SAD/MAD data, as well as initiate a Phase 1b dose-range finding study in obese non-diabetic individuals in the fourth quarter of 2025. CB1 inverse agonism is a clinically validated mechanism known to induce weight loss; however, neuropsychiatric adverse events have been reported in prior clinical studies with both rimonabant and monlunabant. CRB-913 has been specifically formulated to shift the drug exposure from the brain to the periphery to improve safety and tolerability. The drug was shown in pre-clinical studies to have a brain-to-plasma ratio fifty times lower than rimonabant and fifteen times more peripherally restricted than monlunabant.
Previous wording
We are an oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at June 30, 2025, we had an accumulated deficit of approximately $511.5 million. Our net losses for the three months ended June 30, 2025 and 2024, were approximately $17.7 million and $10.0 million, respectively. Our net losses for the six months ended June 30, 2025 and 2024, were approximately $34.6 million and $16.9 million, respectively.
Current wording
We are an oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at September 30, 2025, we had an accumulated deficit of approximately $534.9 million. Our net losses for the three months ended September 30, 2025 and 2024, were approximately $23.3 million and $13.8 million, respectively. Our net losses for the nine months ended September 30, 2025 and 2024, were approximately $58.0 million and $30.7 million, respectively.
Previous wording
Total program-specific costs increased by $7.5 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. Costs related to CRB-601 increased by $2.5 million as a result of higher clinical costs as the first participant in a Phase 1 dose escalation study was dosed in December 2024 and dose escalation is on-going. Costs related to CRB-701 increased by $2.5 million as a result of higher clinical costs as more sites were activated and participants enrolled in the ongoing Phase 1/2 clinical trial, which began in April 2024. CRB-913 costs increased by $2.5 million due to enrollment in the SAD/MAD dose portion of the Phase 1 clinical study, which began in March 2025, as well as manufacturing of drug supply for the Phase 1b dose-range finding study, which is expected to commence in the fourth quarter of 2025.
Current wording
Total program-specific costs increased by $9.4 million for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024. Costs related to CRB-601 increased by $3.6 million as a result of higher clinical and drug supply related costs as the first participant in a Phase 1 dose escalation study was dosed in December 2024 and dose escalation is on-going. Costs related to CRB-701 increased by $5.4 million as a result of higher clinical costs as more sites were activated and participants enrolled in the ongoing Phase 1/2 clinical trial, which began in April 2024. CRB-913 costs increased by $0.4 million primarily due to enrollment in the SAD/MAD dose portion of the Phase 1 clinical study, which began in March 2025, partially offset by a decrease in manufacturing costs.
Previous wording
Personnel-related costs increased by $0.9 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. The increase is primarily due to an increase in headcount.
Current wording
Personnel-related costs increased by $0.8 million for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024. The increase is primarily due to an increase in headcount.
Previous wording
We have a subsidiary in each of the U.K. and Australia. During the three months ended June 30, 2025 and 2024, approximately 31% and 35% of research and development expenses, respectively, were recorded in these entities.
Current wording
We have a subsidiary in each of the U.K. and Australia. During the three months ended September 30, 2025 and 2024, approximately 40% and 41% of research and development expenses, respectively, were recorded in these entities.
Previous wording
General and Administrative. General and administrative expense for the three months ended June 30, 2025 totaled approximately $4.0 million, a decrease of $0.2 million from approximately $4.1 million recorded for the three months ended June 30, 2024. The decrease in second quarter 2025 as compared to second quarter 2024 was primarily attributable to a decrease in legal expenses offset by an increase in personnel related costs due to an increase in headcount.
Current wording
General and Administrative. General and administrative expense for the three months ended September 30, 2025 totaled approximately $3.6 million, a decrease of $1.1 million from approximately $4.7 million recorded for the three months ended September 30, 2024. The decrease in fiscal quarter 2025 as compared to fiscal quarter 2024 was attributable to a decrease in compensation costs of $0.7 million primarily due to a decrease in stock-based compensation costs and a $0.3 million decrease in investor relations expense primarily due to issuing stock pursuant to a professional services agreement with a service provider in the prior year.
Previous wording
Total other income, net for the three months ended June 30, 2025 totaled approximately $1.5 million, an increase of $0.5 million from approximately $1.0 million recorded for the three months ended June 30, 2024. The increase of $0.5 million in 2025 as compared to 2024 was primarily attributable to no interest expense on debt in 2025 as principal payments were made in 2024 ultimately leading to the final payment in August 2024 offset by lower investment income due to lower cash and investment balances.
Current wording
Total other income, net for the three months ended September 30, 2025 totaled approximately $1.1 million, a decrease of $0.6 million from approximately $1.7 million recorded for the three months ended September 30, 2024. The decrease in 2025 as compared to 2024 was primarily attributable to lower investment income due to lower cash and investment balances, partially offset by no interest expense on debt in 2025 as principal payments were made in 2024 ultimately leading to the final payment in August 2024.
Previous wording
Operating Expense. The following table summarizes our operating expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
Operating Expense. The following table summarizes our operating expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Research and Development. The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
Research and Development. The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Total program-specific costs increased by $16.4 million for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024. Costs related to CRB-601 increased by $4.4 million as a result of higher clinical costs as the first participant in the on-going Phase 1 dose escalation study was dosed in December 2024 offset by a decrease in sponsored research agreement expense. Costs related to CRB-701 increased by $7.1 million as a result of higher clinical and drug supply related costs as the Phase 1/2 clinical trial enrollment began in April 2024 and is on-going. CRB-913 costs increased by $4.6 million due to enrollment in the SAD/MAD dose portion of the Phase 1 clinical study, which began in March 2025, as well as manufacturing of drug supply for the Phase 1b dose-range finding study, which is expected to commence in the fourth quarter of 2025.
Current wording
Total program-specific costs increased by $25.7 million for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024. Costs related to CRB-601 increased by $7.9 million as a result of higher clinical and drug supply related costs as the first participant in the on-going Phase 1 dose escalation study was dosed in December 2024, partially offset by a decrease in sponsored research agreement expense. Costs related to CRB-701 increased by $12.5 million as a result of higher clinical and drug supply related costs as the Phase 1/2 clinical trial enrollment began in April 2024 and is on-going. CRB-913 costs increased by $5.1 million due to enrollment in the SAD/MAD dose portion of the Phase 1 clinical study, which began in March 2025, as well as manufacturing of drug supply for the Phase 1b dose-range finding study, which is expected to commence in the fourth quarter of 2025.
Previous wording
Personnel-related costs increased by $2.0 million for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024. The increase is primarily due to an increase in headcount.
Current wording
Personnel-related costs increased by $2.7 million for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024. The increase is primarily due to an increase in headcount.
Previous wording
We have a subsidiary in each of the U.K. and Australia. During the six months ended June 30, 2025 and 2024, approximately 35% and 33% of research and development expenses, respectively, were recorded in these entities.
Current wording
We have a subsidiary in each of the U.K. and Australia. During the nine months ended September 30, 2025 and 2024, approximately 37% and 37% of research and development expenses, respectively, were recorded in these entities.
Previous wording
General and Administrative. General and administrative expense for the six months ended June 30, 2025 totaled approximately $8.1 million, an increase of $0.1 million from approximately $8.0 million recorded for the six months ended June 30, 2024. The increase is primarily related to an increase in stock compensation expense, partially offset by a decrease in legal expenses.
Current wording
General and Administrative. General and administrative expense for the nine months ended September 30, 2025 totaled approximately $11.7 million, a decrease of $1.0 million from approximately $12.7 million recorded for the nine months ended September 30, 2024. The decrease is primarily related to a decrease in legal expenses of $0.6 million and a decrease in facility expense of $0.3 million.
Previous wording
Other Income, Net. The following table summarizes our total other income, net for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
Other Income, Net. The following table summarizes our total other income, net for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Total other income, net for the six months ended June 30, 2025 totaled approximately $4.3 million, an increase of $0.6 million from approximately $3.7 million recorded for the six months ended June 30, 2024. The increase of $0.6 million in 2025 as compared to 2024 was primarily attributable to no interest expense on debt in 2025 as principal payments were made in 2024 ultimately leading to the final payment in August 2024 offset by lower government tax credits. Other income, net includes $1.1 million in employee retention tax credits for the six months ended June 30, 2025 and refundable research and development credits from a foreign tax authority of $2.5 million for the six months ended June 30, 2024.
Current wording
Total other income, net was comparable for the nine months ended September 30, 2025 and 2024. Other income, net includes $1.1 million in employee retention tax credits for the nine months ended September 30, 2025 and refundable research and development credits from a foreign tax authority of $2.5 million for the nine months ended September 30, 2024. This decrease is partially offset by no interest expense on debt in 2025 as principal payments were made in 2024 leading to the final payment in August 2024.
Previous wording
Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At June 30, 2025, our accumulated deficit since inception was approximately $511.5 million.
Current wording
Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At September 30, 2025, our accumulated deficit since inception was approximately $534.9 million.
Previous wording
At June 30, 2025, we had total current assets of approximately $122.8 million and current liabilities of approximately $13.3 million, resulting in working capital of approximately $109.5 million. Of our total cash, cash equivalents, investments, and restricted cash of $117.3 million at June 30, 2025, approximately $115.5 million was held within the U.S.
Current wording
At September 30, 2025, we had total current assets of approximately $107.6 million and current liabilities of approximately $17.1 million, resulting in working capital of approximately $90.5 million. Of our total cash, cash equivalents, investments, and restricted cash of $104.7 million at September 30, 2025, approximately $103.5 million was held within the U.S.
Previous wording
The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was approximately $33.0 million, which includes a net loss of approximately $34.6 million, adjusted for non-cash expenses of approximately $2.5 million primarily related to stock-based compensation expense, and approximately $0.9 million of cash used by net working capital items principally due to an increase in prepaid expenses and other current assets and a decrease in operating lease liabilities partially offset by an increase in accrued expenses.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025 was approximately $48.6 million, which includes a net loss of approximately $58.0 million, adjusted for non-cash expenses of approximately $4.1 million primarily related to stock-based compensation expense, and approximately $5.3 million of cash provided by net working capital items principally due to an increase in accrued expenses, partially offset by decreases in accounts payable and operating lease liabilities.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2025 totaled approximately $35.9 million, which was principally related to proceeds from sales and maturities of marketable securities.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025 totaled approximately $55.5 million, which was principally related to proceeds from sales and maturities of marketable securities.