Corbus Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update
Corbus Pharmaceuticals reported its first-quarter 2024 financial results, highlighting the dosing of the first patient in the U.S. Phase 1 clinical trial of CRB-701, targeting Nectin-4. The company raised $116 million in capital, extending its cash runway through Q1 2027, and appointed Dr. Dominic Smethurst as Chief Medical Officer. CRB-701 Phase 1 data will be presented at ASCO Annual Meeting on June 1, 2024.
Progress in advancing pipeline with dosing of first CRB-701 patient in Phase 1 trial
Raised $116 million in Q1 2024, extending cash runway through Q1 2027
Appointment of Dr. Dominic Smethurst as Chief Medical Officer strengthens management team
Encouraging safety and efficacy data presented for CRB-701 at ASCO GU
CRB-913 shows promise in treating obesity with positive results in DIO mouse model
Net loss of approximately $6.9 million reported for the quarter ended March 31, 2024
Decrease in operating expenses primarily due to upfront licensing fee recorded in 2023
Reliance on cash, cash equivalents, and investments to fund operations through Q1 2027
Upon reviewing the financial health of Corbus Pharmaceuticals, marked by their Q1 2024 net loss of approximately
Corbus has strategically fortified its cash position by raising
The dose escalation data presented for CRB-701 and the upcoming presentation at the ASCO 2024 Annual Meeting are particularly noteworthy. The reported 43% Objective Response Rate (ORR) and 71% Disease Control Rate (DCR) in the patient group treated with CRB-701 herald the potential for a significant clinical advancement in the treatment of Nectin-4 positive tumors. The absence of dose limiting toxicities and side effects such as peripheral neuropathy or skin rash are also promising indicators of CRB-701's safety profile.
Moreover, the initiation of the Phase 1 trial for CRB-601 and the progress towards the IND for CRB-913 signal a robust pipeline, which could potentially lead to value creation over time if the candidates proceed positively through the clinical phases. These advancements in Corbus' diversified oncology and obesity portfolios could have material implications for long-term investors, considering their impact on the company's growth trajectory and future revenue streams.
Dr. Dominic Smethurst's appointment as Chief Medical Officer injects experienced leadership into Corbus at a critical phase in its development cycle. Smethurst's prior experience could prove pivotal in steering the company's clinical programs towards success. While management changes are not typically direct market movers, in the context of a biopharmaceutical firm at Corbus' stage, leadership with a strong track record in drug development can significantly influence investor confidence and the strategic direction of the company.
The investor should also recognize that the biopharmaceutical industry is prone to volatility, heavily dependent on clinical outcomes and regulatory approvals. As such, progress in the pipeline must be monitored closely, with an understanding that while current developments are positive, the inherent risks of drug development can lead to abrupt shifts in the company's valuation and trajectory.
- Phase 1 data for CRB-701 (SYS6002) to be presented at ASCO Annual Meeting on June 1, 2024
$116M of capital raised in Q1 2024 extending cash runway through Q1 2027
- Appointed Dr. Dominic Smethurst as Chief Medical Officer
NORWOOD, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today provided a corporate update and reported financial results for the quarter ended March 31, 2024.
“During the first quarter of 2024, we continued to make significant progress in advancing our pipeline toward meaningful milestones led by the dosing of the first patient in our U.S. Phase 1 clinical trial of CRB-701, our next-generation antibody drug conjugate targeting expression of Nectin-4,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “The potential of CRB-701 was highlighted at ASCO GU in January 2024. The dose escalation data, presented by our development partner CSPC, demonstrated a differentiated safety and PK profile compared to enfortumab vedotin, as well as an emerging efficacy signal in both bladder and cervical cancer patients who are Nectin-4 positive. We look forward to CSPC’s presentation of updated data at the ASCO 2024 Annual Meeting. During the quarter, we also continued to advance CRB-913 for the treatment of obesity and expect to dose the first patient in Q1 2025. We strengthened our balance sheet by raising
Key Corporate and Program Updates:
CRB-701:
CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4 that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2 using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer.
The first U.S. patient was dosed in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics (“PK”) of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to present the U.S. dose escalation data by Q1 2025.
Encouraging safety and efficacy data from the Phase 1 dose escalation study in China for patients with Nectin-4 positive tumors was presented in January 2024 by our development partner CSPC at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO GU”) as a Poster Presentation.
Summary of data presented at ASCO GU:
- Q3W schedule of CRB-701 (SYS6002) demonstrated a
43% ORR and71% DCR (n=7) at predicted therapeutically relevant doses (>=2.7mgs/kg). - All assessable Nectin-4 positive study participants with mUC or cervical cancer treated at or above this dose demonstrated some level of disease control.
- No dose limiting toxicities were observed to date at doses up to 3.6 mg/kg with further escalation at 4.5 mg/kg ongoing.
- No cases of peripheral neuropathy or skin rash have been observed to date.
Updated data from this study will be presented by CSPC as a poster at the ASCO 2024 Annual Meeting on June 1, 2024.
CRB-913:
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, as a monotherapy and in combination with incretin analogues (tirzepatide, semaglutide, or liraglutide), demonstrates a reduction in body weight in DIO mice and improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology. The Company is currently conducting IND-enabling studies and expects to dose the first patient in the Phase 1 study in Q1 2025.
CRB-601:
CRB-601 is a high affinity and selective anti-αvβ8 monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells in the tumor microenvironment. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with anti-PD-1 checkpoint inhibitor therapy compared to either single agent alone.
In January 2024, the FDA cleared the IND for CRB-601 and the Company expects to initiate a Phase 1 study of CRB-601 in the summer of 2024.
Immediately following the ASCO GU data, the Company completed a public offering raising
Dr. Dominic Smethurst Appointed as Chief Medical Officer
In February 2024, the Company appointed Dr. Dominic Smethurst, MA MRCP, as the Company’s Chief Medical Officer (“CMO”). He has over twenty years of experience working with pharmaceutical and biotechnology companies and most recently served as the CMO of Bicycle Therapeutics.
Financial Results for Quarter Ended March 31, 2024:
The Company reported a net loss of approximately
Operating expenses decreased by
As of March 31, 2024, the Company had
About Corbus
Corbus Pharmaceuticals Holdings, Inc. 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. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACTS:
Sean Moran
Chief Financial Officer
smoran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
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| Corbus Pharmaceuticals Holdings, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
| For the Three Months Ended March 31, | |||||||||
| 2024 | 2023 | ||||||||
| Operating expenses: | |||||||||
| Research and development | $ | 5,761,494 | $ | 13,388,343 | |||||
| General and administrative | 3,861,251 | 3,908,682 | |||||||
| Total operating expenses | 9,622,745 | 17,297,025 | |||||||
| Operating loss | (9,622,745 | ) | (17,297,025 | ) | |||||
| Other income (expense), net: | |||||||||
| Other income, net | 2,909,097 | 229,507 | |||||||
| Interest expense, net | (177,015 | ) | (678,022 | ) | |||||
| Change in fair value of derivative liability | 28,568 | — | |||||||
| Foreign currency transaction (loss) gain, net | (36,676 | ) | 728 | ||||||
| Other income (expense), net | 2,723,974 | (447,787 | ) | ||||||
| Net loss | $ | (6,898,771 | ) | $ | (17,744,812 | ) | |||
| Net loss per share, basic and diluted | $ | (0.83 | ) | $ | (4.24 | ) | |||
| Weighted average number of common shares outstanding, basic and diluted | 8,310,508 | 4,181,556 | |||||||
| Comprehensive loss: | |||||||||
| Net loss | $ | (6,898,771 | ) | $ | (17,744,812 | ) | |||
| Other comprehensive (loss) income : | |||||||||
| Change in unrealized (loss) gain on marketable debt securities | (326,949 | ) | 57,623 | ||||||
| Total other comprehensive (loss) income | (326,949 | ) | 57,623 | ||||||
| Total comprehensive loss | $ | (7,225,720 | ) | $ | (17,687,189 | ) | |||
| Corbus Pharmaceuticals Holdings, Inc. Consolidated Balance Sheets | ||||||||
| March 31, 2024 (Unaudited) | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,103,120 | $ | 13,723,681 | ||||
| Investments | 106,000,091 | 7,182,325 | ||||||
| Restricted cash | 284,950 | 192,475 | ||||||
| Prepaid expenses and other current assets | 1,308,336 | 2,447,549 | ||||||
| Total current assets | 121,696,497 | 23,546,030 | ||||||
| Restricted cash | 384,950 | 477,425 | ||||||
| Property and equipment, net | 821,526 | 973,214 | ||||||
| Operating lease right-of-use assets | 2,841,189 | 3,062,920 | ||||||
| Other assets | — | 212,804 | ||||||
| Total assets | $ | 125,744,162 | $ | 28,272,393 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Notes payable | $ | 189,818 | $ | 300,664 | ||||
| Accounts payable | 2,081,812 | 3,178,516 | ||||||
| Accrued expenses | 9,398,225 | 11,030,506 | ||||||
| Derivative liability | 10,882 | 39,450 | ||||||
| Operating lease liabilities, current | 1,477,669 | 1,436,723 | ||||||
| Current portion of long-term debt | 12,764,915 | 15,908,214 | ||||||
| Total current liabilities | 25,923,321 | 31,894,073 | ||||||
| Other long-term liabilities | — | 44,411 | ||||||
| Operating lease liabilities, noncurrent | 2,855,140 | 3,238,631 | ||||||
| Total liabilities | 28,778,461 | 35,177,115 | ||||||
| Stockholders’ equity | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, 10,507,237 and 4,423,683 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 1,050 | 442 | ||||||
| Additional paid-in capital | 540,875,910 | 429,780,375 | ||||||
| Accumulated deficit | (443,582,754 | ) | (436,683,983 | ) | ||||
| Accumulated other comprehensive loss | (328,505 | ) | (1,556 | ) | ||||
| Total stockholders’ equity (deficit) | 96,965,701 | (6,904,722 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 125,744,162 | $ | 28,272,393 | ||||
FAQ
<p>When will Phase 1 data for CRB-701 be presented?</p>
Phase 1 data for CRB-701 will be presented at the ASCO Annual Meeting on June 1, 2024.
<p>Who was appointed as Chief Medical Officer?</p>
Dr. Dominic Smethurst was appointed as Chief Medical Officer in February 2024.
<p>How much capital was raised in Q1 2024?</p>
$116 million of capital was raised in Q1 2024.
<p>What is the cash runway extended through?</p>
The cash runway was extended through Q1 2027.
<p>What did the Company report as its net loss for the quarter ended March 31, 2024?</p>
The Company reported a net loss of approximately $6.9 million for the quarter ended March 31, 2024.
