Q - Corbus Pharmaceuticals Holdings,

Previous wording

Corbus Pharmaceuticals Holdings, Inc. (the "Company," "Corbus," "we," "us," or "our") is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE"); and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity.

Current wording

Corbus Pharmaceuticals Holdings, Inc. (the "Company," "Corbus," "we," "us," or "our") is a clinical-stage oncology and obesity company and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE"); and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity.

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 is currently being investigated by CSPC in a Phase 1 dose expansion clinical trial in participants with advanced solid tumors in China (the "China study"). We commenced a corresponding Phase 1 dose escalation 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. The dose optimization portion in the Western study is currently ongoing and we are in the process of adding additional clinical sites in Europe. Both studies are enrolling participants with advanced solid tumors associated with Nectin-4 expression.

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 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.

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.

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. We expect to report dose escalation data in the fourth quarter of 2025.

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/multiple ascending ("SAD/MAD") dose portion of a Phase 1 study in the first quarter of 2025. CB1 inverse agonism is a highly clinically validated mechanism 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 has 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, 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.

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 March 31, 2025, we had an accumulated deficit of approximately $493.9 million. Our net losses for the three months ended March 31, 2025 and 2024, were approximately $17.0 million and $6.9 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 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.

Previous wording

There have been no changes to the critical accounting estimates we identified in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report.

Current wording

There have been no changes to the critical accounting estimates we identified in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 11, 2025 (the “2024 Annual Report”).

Previous wording

Personnel related costs increased by $1.1 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The increase is primarily due to an increase in headcount.

Current 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.

Previous wording

We have a subsidiary in each of the U.K. and Australia. During the three months ended March 31, 2025 and 2024, approximately 38% and 30% 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 June 30, 2025 and 2024, approximately 31% and 35% 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 March 31, 2025 totaled approximately $4.1 million, an increase of $0.3 million from approximately $3.9 million recorded for the three months ended March 31, 2024. The increase in first quarter 2025 as compared to first quarter 2024 was primarily attributable to an increase in stock-based compensation costs.

Current 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.

Previous wording

Total program-specific costs increased by $8.9 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. Costs related to CRB-601 increased by $1.9 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 $4.7 million as a result of higher clinical and drug supply related costs as the Phase 1 clinical trial enrollment began in April 2024 and is on-going. CRB-913 costs increased by $2.2 million due to the manufacturing of drug supply and commencement of the SAD/MAD dose portion of the Phase 1 clinical study during the first quarter of 2025.

Current 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.

Previous wording

Total other income, net was comparable for the three months ended March 31, 2025 and 2024. Other income, net includes $1.1 million in employee retention tax credits for the three months ended March 31, 2025 and refundable research and development credits from a foreign tax authority of $2.5 million for the three months ended March 31, 2024.

Current 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.

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 March 31, 2025, our accumulated deficit since inception was approximately $493.9 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 June 30, 2025, our accumulated deficit since inception was approximately $511.5 million.

Previous wording

At March 31, 2025, we had total current assets of approximately $137.4 million and current liabilities of approximately $11.6 million, resulting in working capital of approximately $125.7 million. Of our total cash, cash equivalents, investments, and restricted cash of $133.5 million at March 31, 2025, approximately $131.3 million was held within the U.S.

Current 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.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was approximately $16.4 million, which includes a net loss of approximately $17.0 million, adjusted for non-cash expenses of approximately $1.6 million primarily related to stock-based compensation expense, and approximately $1.0 million of cash used by net working capital items principally due to a decrease in accounts payable and increases in accrued expenses and prepaid expenses and other current assets.

Current 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.

Previous wording

Cash provided by investing activities for the three months ended March 31, 2025 totaled approximately $18.1 million, which was principally related to proceeds from sales and maturities of marketable securities.

Current 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.

Previous wording

No cash was provided by financing activities for the three months ended March 31, 2025.

Current wording

No cash was provided by financing activities for the six months ended June 30, 2025.

Previous wording

Based on our current planned operations and our cash, cash equivalents, and investments of approximately $132.8 million at March 31, 2025, we expect to have sufficient funds to meet our operating and capital requirements to support our operations through the second quarter of 2027.

Current wording

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.

Previous wording

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC ("Jenrin"), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. A $0.4 million milestone payment was achieved in the first quarter of 2025 and paid in April 2025. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions.

Current wording

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC ("Jenrin"), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions. A $0.4 million milestone payment was achieved in the first quarter of 2025 associated with the progression into a clinical trial for CRB-913 and paid during the second quarter of 2025. The Company is obligated to pay Jenrin up to $18.0 million in additional potential milestone payments for further development of CRB-913.

Previous wording

Pursuant to the terms of the CSPC License Agreement with CSPC, we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

Current wording

Pursuant to the terms of the license agreement with CSPC (the “CSPC License Agreement”), we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.