Corbus Pharmaceuticals Holdings Inc

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; 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 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.

Previous wording

CRB-701 is a next-generation ADC targeting the expression of Nectin-4 on cancer cells to release a cytotoxic payload. 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 (the “CSPC License Agreement”). The Investigational New Drug (“IND”) application for CRB-701 was cleared by the U.S. Food and Drug Administration (“FDA”) in 2022 and the drug is currently being investigated by CSPC in a Phase 1 clinical trial in patients with advanced solid tumors in China. On June 1, 2024, updated clinical data was presented at ASCO 2024 by CSPC building upon the data presented at ASCO-GU on January 26, 2024. The larger data set included 37 patients of whom 25 patients reflective of seven dose levels had been evaluated for efficacy at the time of the data cut. The emerging clinical data shows that CRB-701 was well-tolerated and demonstrated an overall response rate (“ORR”) of 44% and a disease control rate (“DCR”) of 78% in metastatic urothelial cancer (“mUC”) and 43% ORR and 86% DCR in cervical cancer. No dose limiting toxicities (“DLTs”) have been observed to date in doses up to and including 4.5 mg/Kg.

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 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.

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. The 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 patients with solid tumors in combination with existing therapies, including checkpoint inhibitors. On January 9, 2024, we announced that the FDA cleared the IND for CRB-601 and we expect to enroll the first patient in a Phase 1 study in Q4 2024.

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.

Previous wording

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. We are currently conducting IND-enabling studies and we expect to treat the first patient in a Phase 1 study in the first quarter of 2025.

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/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.

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 September 30, 2024, we had an accumulated deficit of approximately $467.4 million. Our net losses for the three months ended September 30, 2024 and 2023, were approximately $13.8 million and $10.1 million, respectively. For the nine months ended September 30, 2024 and 2023, our net losses were approximately $30.7 million and $36.6 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 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.

Previous wording

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in 2024 as compared to 2023 as we incur Phase 1 clinical trial costs for both CRB-701 and CRB-601. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

Current wording

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our product candidates. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

Previous wording

The following table summarizes our operating expenses for the three months ended September 30, 2024 and 2023 (in thousands):

Current wording

Operating Expense. The following table summarizes our operating expenses for the three months ended March 31, 2025 and 2024 (in thousands):

Previous wording

We have a subsidiary in each of the U.K. and Australia and approximately 41% and 64% of research and development expenses recorded for the three months ended September 30, 2024 and 2023, respectively was recorded in these entities.

Current 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.

Previous wording

General and Administrative. General and administrative expenses for the three months ended September 30, 2024 totaled approximately $4.7 million, an increase of $1.8 million from approximately $2.9 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was attributable to increases in stock-based compensation costs of $1.2 million primarily due to stock options being granted at higher current fair values as compared to earlier grants and a $0.4 million increase in investor relations expense primarily due to issuing common stock pursuant to a professional services agreement with a service provider.

Current 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.

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 September 30, 2024, our accumulated deficit since inception was approximately $467.4 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 March 31, 2025, our accumulated deficit since inception was approximately $493.9 million.

Previous wording

At September 30, 2024, we had total current assets of approximately $160.9 million and current liabilities of approximately $11.6 million, resulting in working capital of approximately $149.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $160.0 million at September 30, 2024, approximately $156.8 million was held within the U.S.

Current 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.

Previous wording

The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):

Current wording

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

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $30.9 million, which includes a net loss of approximately $30.7 million, adjusted for non-cash expenses of approximately $2.9 million largely related to stock-based compensation expense offset by net amortization on discount of investments, and approximately $3.0 million of cash used in net working capital items principally due to decreases in accrued expenses and operating lease liabilities offset by a decrease in prepaid expenses and other current assets.

Current 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.

Previous wording

Cash used by investing activities for the nine months ended September 30, 2024 totaled approximately $130.0 million, which was principally related to purchases of investments.

Current 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.

Previous wording

Cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $166.6 million, which was related to the issuance of common stock. On January 31, 2024, we entered into an underwriting agreement with Jefferies, as representative of the underwriters, relating to an underwritten public offering of 4,325,000 shares of our common stock at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, we completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, for the nine months ended September 30, 2024, we sold an aggregate of 2,484,517 shares of common stock under the Open Market Sale Agreement, for net proceeds of approximately $91.4 million.

Current wording

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

Previous wording

We expect our cash, cash equivalents, and investments of approximately $159.4 million at September 30, 2024 will be sufficient to meet our operating and capital requirements to support our operations through the third quarter of 2027, based on current planned expenditures.

Current 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.

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. 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. 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.

Previous wording

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay potential milestone payments totaling up to $153.2 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.

Current wording

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay up to $150.8 million in remaining potential milestone payments based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.