Corbus Pharmaceuticals Holdings Inc

Previous wording

Corbus Pharmaceuticals Holdings, Inc. (the “Company,” “Corbus,” “we,” “us,” or “our”) is a precision oncology 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; 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 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 dose-escalation 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. On April 2, 2024, the first patient in the U.S. Phase 1 clinical trial was dosed. The study is currently enrolling patients with mUC and other Nectin-4 enriched tumors.

Current 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.

Previous wording

CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. In a diet-induced obesity (“DIO”) mouse model, CRB-913 demonstrates a reduction in body weight, body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and improvements in liver histology. These outcomes were further improved when CRB-913 was used in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide). 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 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.

Previous wording

On May 31, 2023, the Company entered into the Open Market Sale Agreement with Jefferies, as sales agent. Under the Open Market Sale Agreement, the Company 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 six months ended June 30, 2024, the Company sold an aggregate of 881,399 and 1,820,787 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $35.6 million and $55.8 million, respectively. As of June 30, 2024, approximately $113.2 million was available for issuance and sale under the Open Market Sale Agreement.

Current wording

On May 31, 2023, we entered into the Open Market Sale Agreement with 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, 2024, we sold an aggregate of 663,730 and 2,484,517 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $35.6 million and $91.4 million, respectively. As of September 30, 2024, approximately $76.4 million was available for issuance and sale under the Open Market Sale Agreement.

Previous wording

We are a precision oncology 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, 2024, we had an accumulated deficit of approximately $453.6 million. Our net losses for the three months ended June 30, 2024 and 2023, were approximately $10.0 million and $8.8 million, respectively. For the six months ended June 30, 2024 and 2023, our net losses were approximately $16.9 million and $26.5 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, 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.

Previous wording

Research and Development. Research and development expenses for the three months ended June 30, 2024 totaled approximately $6.9 million, an increase of $2.7 million from approximately $4.2 million recorded for the three months ended June 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was primarily attributable to increases of $2.0 million in CRB-701 clinical trial costs with our contract research organizations ("CROs") and clinical sites, as well as $0.3 million in drug manufacturing costs for CRB-913 and $0.2 million in higher stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants. These increases are offset by a $0.5 million decrease in toxicology costs as we transition from pre-clinical to clinical phase for CRB-601.

Current wording

Research and Development. Research and development expenses for the three months ended September 30, 2024 totaled approximately $10.8 million, an increase of $4.3 million from approximately $6.6 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was primarily attributable to increases of $3.2 million primarily related to CRB-701 clinical trial costs with our contract research organizations ("CROs") and clinical sites, $1.0 million in CRB-913 IND-enabling studies, and $0.4 million in higher compensation costs mainly due to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants. These increases are offset by a $0.7 million decrease in manufacturing costs for CRB-601.

Previous wording

The Company has a subsidiary in each of the United Kingdom and Australia and approximately 35% and 46% of research and development expenses recorded for the three months ended June 30, 2024 and 2023, respectively was recorded in these entities.

Current 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.

Previous wording

Other Income (Expense), Net. Other income (expense), net for the three months ended June 30, 2024 was approximately $1.0 million in income as compared to other expense of approximately $0.6 million recorded for the three months ended June 30, 2023. The increase of $1.6 million in 2024 as compared to 2023 was primarily attributable to higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.

Current wording

Other income (expense), net for the three months ended September 30, 2024 was approximately $1.7 million in income as compared to other expense of approximately $0.6 million recorded for the three months ended September 30, 2023. The increase of $2.3 million in 2024 as compared to 2023 was primarily attributable to higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.

Previous wording

Research and Development. Research and development expenses for the six months ended June 30, 2024 totaled approximately $12.6 million, a decrease of $5.0 million from approximately $17.6 million recorded for the six months ended June 30, 2023. The decrease in fiscal 2024 as compared to fiscal 2023 was primarily attributable to decreases in licensing costs of $7.5 million associated with the CSPC License Agreement and $1.2 million associated with the achievement of a development milestone under the UCSF License Agreement. This decrease is offset by increases of $3.2 million in CRB-701 clinical trial costs with our contract research organizations ("CROs") and clinical sites, as well as $0.9 million in drug manufacturing costs, primarily related to CRB-701 drug purchases, packaging, labeling, and distribution to clinical trial sites.

Current wording

Research and Development. Research and development expenses for the nine months ended September 30, 2024 totaled approximately $23.4 million, a decrease of $0.8 million from approximately $24.2 million recorded for the nine months ended September 30, 2023. The decrease in fiscal 2024 as compared to fiscal 2023 was primarily attributable to decreases in licensing costs of $7.5 million associated with the CSPC License Agreement and $1.2 million associated with the achievement of a development milestone under the UCSF License Agreement, as well as a decrease of $0.6 million in sponsored research agreement expense as the contract ended in January 2024. These decreases are offset by a $6.6 million increase in CRB-701 clinical trial costs with our CROs and clinical sites, as well as an increase of $0.8 million in CRB-913 IND-enabling studies, $0.5 million increase in manufacturing costs primarily related to CRB-701, and $0.5 million in higher compensation costs primarily related to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants.

Previous wording

The Company has a subsidiary in each of the United Kingdom and Australia and approximately 33% and 20% of research and development expenses recorded for the six months ended June 30, 2024 and 2023, respectively was recorded in these entities.

Current wording

We have a subsidiary in each of the U.K. and Australia and approximately 37% and 32% of research and development expenses recorded for the nine months ended September 30, 2024 and 2023, respectively, was recorded in these entities.

Previous wording

Other Income (Expense), Net. Other income (expense), net for the six months ended June 30, 2024 was approximately $3.7 million in income as compared to other expense of approximately $1.0 million recorded for the six months ended June 30, 2023. The increase of $4.7 million in 2024 as compared to 2023 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2.5 million in 2024, as well as higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.

Current wording

Other income (expense), net for the nine months ended September 30, 2024 was approximately $5.4 million in income as compared to other expense of approximately $1.6 million recorded for the nine months ended September 30, 2023. The increase of $7.0 million in 2024 as compared to 2023 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2.5 million in 2024, as well as higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 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, 2024, our accumulated deficit since inception was approximately $453.6 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, 2024, our accumulated deficit since inception was approximately $467.4 million.

Previous wording

At June 30, 2024, we had total current assets of approximately $148.3 million and current liabilities of approximately $24.0 million, resulting in working capital of approximately $124.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $147.7 million at June 30, 2024, approximately $143.4 million was held within the U.S.

Current 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.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was approximately $16.9 million, which includes a net loss of approximately $16.9 million, adjusted for non-cash expenses of approximately $1.0 million largely related to stock-based compensation expense offset by net amortization on discount of investments, and approximately $1.0 million of cash used in net working capital items principally due to decreases in accounts payable 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 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.

Previous wording

Cash used by investing activities for the six months ended June 30, 2024 totaled approximately $114.7 million, which was principally related to purchases of marketable securities.

Current 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.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024 totaled approximately $141.5 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 six months ended June 30, 2024, we sold an aggregate of 1,820,787 shares of common stock under the Open Market Sale Agreement, for net proceeds of approximately $55.8 million.

Current 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.

Previous wording

We expect our cash, cash equivalents, and investments of approximately $147.0 million at June 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

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.

Previous wording

We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701 and CRB-601. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.

Current wording

We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701, CRB-601 and CRB-913. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.