Corbus Pharmaceuticals Holdings Inc

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 January 26, 2024, we presented data from the Phase 1 dose-escalation trial in China for the first eighteen patients reflective of the first six dose cohorts. The data was presented at ASCO-GU. The emerging clinical data shows that CRB-701 was well-tolerated and demonstrated an overall response rate ("ORR") of 43% and a disease control rate ("DCR") of 71% in the seven patients who received doses predicted to be therapeutically relevant. On April 2, 2024, the first patient in the U.S. Phase 1 clinical trial was dosed. The study is currently enrolling patients with metastatic urothelial cancer ("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 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.

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 the summer of 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. 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.

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 March 31, 2024, we had an accumulated deficit of approximately $443,583,000. Our net losses for the three months ended March 31, 2024 and 2023, were approximately $6,899,000 and $17,745,000, respectively.

Current 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.

Previous wording

We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to decline in 2024 as compared to 2023 as the upfront cost to license CRB-701 in 2023 of $7,500,000 will not recur and we incurred significant expenses in 2023 to manufacture CRB-601 for clinical studies. 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 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.

Previous wording

During 2018, we formed subsidiaries in the United Kingdom and Australia and approximately 30% and 16% of research and development expenses recorded for the three months ended March 31, 2024 and 2023, respectively, were recorded in these entities.

Current 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.

Previous wording

Research and Development. Research and development expenses for the three months ended March 31, 2024 totaled approximately $5,761,000, a decrease of $7,627,000 from approximately $13,388,000 recorded for the three months ended March 31, 2023. The decrease in first quarter 2024 as compared to first quarter 2023 was primarily attributable to a decrease of $7,500,000 in upfront licensing costs associated with the CSPC License Agreement and $1,200,000 associated with the achievement of the first development milestone under the UCSF License Agreement. These decreases were offset by an increase in contract research organizations ("CROs") costs associated with the start of the CRB-701 clinical trial in the U.S.

Current 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.

Previous wording

Other Income (Expense), Net. Other income (expense), net for the three months ended March 31, 2024 was income of approximately $2,724,000, an increase of $3,172,000 from an expense of approximately $448,000 recorded for the three months ended March 31, 2023. The increase in first quarter 2024 as compared to first quarter 2023 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2,500,000, as well as higher investment income.

Current 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.

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, 2024, our accumulated deficit since inception was approximately $443,583,000.

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, 2024, our accumulated deficit since inception was approximately $453.6 million.

Previous wording

At March 31, 2024, we had total current assets of approximately $121,696,000 and current liabilities of approximately $25,923,000, resulting in working capital of approximately $95,773,000. Of our total cash, cash equivalents, investments, and restricted cash of $120,773,000 at March 31, 2024, approximately $115,944,000 was held within the U.S.

Current 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.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2024 was approximately $7,967,000, which includes a net loss of approximately $6,899,000, adjusted for non-cash expenses of approximately $418,000 primarily related to stock-based compensation expense, and approximately $1,487,000 of cash used by net working capital items principally due to decreases in accounts payable and accrued expenses offset by an increase in prepaid expenses and other current assets.

Current 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.

Previous wording

Cash used in investing activities for the three months ended March 31, 2024 totaled approximately $98,236,000, which was principally related to purchases of marketable securities.

Current 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.

Previous wording

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 $94,500,000 and net proceeds of $88,600,000 after deducting underwriting discounts and commissions and other offering expenses payable by us.

Current 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.

Previous wording

We expect our cash, cash equivalents, and investments of approximately $120,103,000 at March 31, 2024 will be sufficient to meet our operating and capital requirements to support our operations through the first quarter of 2027, based on current planned expenditures.

Current 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.

Previous wording

We will need to raise significant additional capital to continue to fund operations, including pre-clinical and clinical costs for our product candidates. If we are unable to raise sufficient capital in the future, we may be required to undertake cost-cutting measures, including delaying or discontinuing certain clinical activities. We may seek to sell common stock, preferred stock, 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 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.

Previous wording

Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned clinical trials.

Current wording

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned clinical trials.

Previous wording

Pursuant to the terms of the license agreement (the "Milky Way License Agreement") with Milky Way BioPharma, LLC (“Milky Way”), we are obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement.

Current wording

Pursuant to the terms of the license agreement (the "Milky Way License Agreement") with Milky Way BioPharma, LLC (“Milky Way”), we were obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we were obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement.

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 $153.15 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 $50,000 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 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.