Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update
- Encouraging first-in-human data for CRB-701 (SYS6002) targeting Nectin-4 presented at ASCO-GU 2024.
- IND application for CRB-601 cleared, with Ph1 study set to commence in Summer 2024.
- Pre-clinical data for CRB-913 presented at Obesity Week, IND filing expected by end of 2024.
- $127 million of cash and investments as of February 2, 2024, providing over 3 years of projected runway.
- Appointment of Dr. Dominic Smethurst as Chief Medical Officer.
- $116 million raised in 2024 through public offering and ATM sales.
- Net loss of $8.0 million reported for Q4 2023, with operating expenses decreasing.
- Total cash, cash equivalents, and investments increased to $127 million by February 2, 2024.
- None.
Insights
The recent announcement by Corbus Pharmaceuticals Holdings, Inc. regarding their financial position and the progress of their clinical pipeline is a significant development for investors and analysts monitoring the biotechnology sector. The company's successful capital raise of $116 million in 2024, which has extended its cash runway through Q1 2027, is a positive indicator of investor confidence and financial stability. This capital infusion is crucial as it supports ongoing research and development activities without the immediate need for further fundraising, which could have diluted shareholder value.
Moreover, the reported net loss of $44.6 million for the year-ended 2023, while substantial, must be contextualized within the biotech industry where high R&D costs are the norm before reaching profitability. The slight increase in net loss compared to the previous year suggests controlled spending relative to their developmental progress. Investors should monitor the company's burn rate and how effectively the raised capital is being utilized to advance their pipeline.
The advancement of CRB-701 and CRB-601 into clinical studies represents a critical milestone for Corbus Pharmaceuticals. CRB-701's first-in-human data showing a favorable safety profile and preliminary efficacy in bladder and cervical cancer patients provides a compelling case for its continued development. The absence of dose-limiting toxicities and peripheral neuropathy in early trials is particularly noteworthy, as these are common concerns with antibody drug conjugates (ADCs). The drug's differentiated pharmacokinetic profile compared to enfortumab vedotin, an already approved ADC for urothelial cancer, indicates potential for a competitive advantage in the market.
For CRB-601, the FDA's clearance of the IND application signals regulatory confidence in the pre-clinical data and allows the company to proceed with human trials. The therapeutic approach of blocking TGFβ activation in the tumor microenvironment may offer synergistic effects with existing PD-1 inhibitors, which could lead to an enhanced anti-tumor response. The potential for CRB-601 to be used in combination therapies expands its clinical utility and market potential.
Corbus' strategic focus on precision oncology and obesity, two areas with significant unmet medical needs, positions the company to tap into large and growing markets. The obesity treatment market, in particular, is experiencing a surge in interest due to rising global obesity rates and the limited efficacy of current treatment options. CRB-913's pre-clinical data suggest it could be a promising candidate in this space. Its mechanism as a CB1 receptor inverse agonist could differentiate it from other obesity treatments and the observed improvements in obesity-related biomarkers could translate into clinical benefits.
It is essential to consider the competitive landscape and the potential market size for each of Corbus' candidates. While early positive data can be encouraging, the transition from pre-clinical to clinical efficacy is fraught with challenges. Investors should assess the risks of clinical trial outcomes, potential regulatory hurdles and the company's ability to execute on its strategic goals. The appointment of Dr. Dominic Smethurst as CMO, with his experience in advancing Nectin-4 investigational drugs, is a strategic move that could strengthen the company's clinical development expertise.
- Encouraging CRB-701 (SYS6002) First-in-Human Data Presented at ASCO-GU 2024; first patient expected to be dosed in US Ph1 study by end of March 2024
- IND Application for CRB-601 cleared; Ph1 study on track to commence in Summer of 2024
- Pre-clinical data for CRB-913 presented at Obesity Week; IND filing on track by the end of 2024
$127M of cash & investments at February 2, 2024; 3+ years of projected runway through Q1 2027- Appointed Dr. Dominic Smethurst as Chief Medical Officer
NORWOOD, Mass., March 12, 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 fourth quarter of 2023 and year-ended 2023.
“In 2023 we made significant progress in advancing our pipeline to meaningful milestones. These efforts culminated in us strengthening our balance sheet by raising
Key Corporate and Program Updates:
CRB-701 - a Nectin-4 ADC
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (“ADC”) 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.
Encouraging safety and efficacy data from the Ph1 dose-escalation study in China for patients with Nectin-4 positive tumors was presented in January 2024 by CSPC at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”) Poster.
Summary of Ph1 Results:
- 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 (“DLTs”) were observed to date 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.
The Company is on track to dose the first patient in the US dose-escalation study by the end of March 2024. The Company expects to provide a clinical update for CSPC’s dose-escalation study in mid-2024 and to present US dose-escalation data by Q1 2025.
CRB-601-TGFβ blocking monoclonal antibody targeting the integrin αVβ8
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 and the Company expects to enroll the first patient in the Ph1 study in the summer of 2024. The Company expects to complete the CRB-601 Ph1 dose-escalation study (monotherapy and in combination with PD-1) by the end of 2024.
CRB-913-CB1 receptor inverse agonist for the treatment of obesity
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 presented CRB-913 pre-clinical data at Obesity Week as an oral presentation and as a late breaking poster in October 2023. The study was also published in Obesity in November 2023. The Company is currently conducting IND enabling studies and expects to file an IND in the fourth quarter of 2024.
In February 2024, the Company closed 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). In this role, Dr. Smethurst is guiding the clinical development of the Company’s clinical pipeline. Dr. Dominic Smethurst has over twenty years of experience working with various pharmaceutical and biotechnology companies and most recently served as CMO of Bicycle Therapeutics, where he helped advance Nectin-4 investigational drugs through early stage and into late-stage development.
Financial Results for Fourth Quarter Ended December 31, 2023
The Company reported a net loss of approximately
Operating expenses for Q4 2023 decreased by
The Company reported
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 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 CONTACT:
Sean Moran
Chief Financial Officer
Sean.moran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
---tables to follow---
| Corbus Pharmaceuticals Holdings, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||||||
| Unaudited For the Three Months Ended December 31, | For the Twelve Months Ended December 31, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | $ | 6,980,116 | $ | 6,242,758 | $ | 31,167,660 | $ | 16,136,826 | ||||||||||||
| General and administrative | 3,123,231 | 4,554,062 | 13,909,641 | 18,698,619 | ||||||||||||||||
| Litigation Settlement | — | — | — | 5,000,000 | ||||||||||||||||
| Total operating expenses | 10,103,347 | 10,796,820 | 45,077,301 | 39,835,445 | ||||||||||||||||
| Operating loss | (10,103,347 | ) | (10,796,820 | ) | (45,077,301 | ) | (39,835,445 | ) | ||||||||||||
| Other income (expense), net: | ||||||||||||||||||||
| Other income (expense), net | 2,759,731 | 275,549 | 3,389,440 | (48,773 | ) | |||||||||||||||
| Interest income (expense), net | (707,010 | ) | (640,954 | ) | (2,923,974 | ) | (2,132,091 | ) | ||||||||||||
| Change in fair value of derivative liability | (2,582 | ) | 96,842 | (2,582 | ) | 96,842 | ||||||||||||||
| Foreign currency exchange gain (loss), net | 31,814 | 186,330 | 11,101 | (427,436 | ) | |||||||||||||||
| Other income (expense), net | 2,081,953 | (82,233 | ) | 473,985 | (2,511,458 | ) | ||||||||||||||
| Net loss | $ | (8,021,394 | ) | $ | (10,879,053 | ) | $ | (44,603,316 | ) | $ | (42,346,903 | ) | ||||||||
| Net loss per share, basic and diluted | $ | (1.81 | ) | $ | (2.61 | ) | $ | (10.31 | ) | $ | (10.15 | ) | ||||||||
| Weighted average number of common shares outstanding, basic and diluted | 4,423,683 | 4,171,297 | 4,327,568 | 4,170,675 | ||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||
| Net loss | $ | (8,021,394 | ) | $ | (10,879,053 | ) | $ | (44,603,316 | ) | $ | (42,346,903 | ) | ||||||||
| Other comprehensive income (loss): | ||||||||||||||||||||
| Change in unrealized gain (loss) on marketable debt securities | 6,479 | 80,782 | 124,536 | (63,647 | ) | |||||||||||||||
| Total other comprehensive income (loss) | 6,479 | 80,782 | 124,536 | (63,647 | ) | |||||||||||||||
| Total comprehensive loss | $ | (8,014,915 | ) | $ | (10,798,271 | ) | $ | (44,478,780 | ) | $ | (42,410,550 | ) | ||||||||
| Corbus Pharmaceuticals Holdings, Inc. Consolidated Balance Sheets | ||||||||
| December 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,723,681 | $ | 17,002,715 | ||||
| Investments | 7,182,325 | 42,194,296 | ||||||
| Restricted cash | 192,475 | 192,475 | ||||||
| Prepaid expenses and other current assets | 2,447,549 | 791,616 | ||||||
| Total current assets | 23,546,030 | 60,181,102 | ||||||
| Restricted cash | 477,425 | 477,425 | ||||||
| Property and equipment, net | 973,214 | 1,613,815 | ||||||
| Operating lease right of use assets | 3,062,920 | 3,884,252 | ||||||
| Other assets | 212,804 | 155,346 | ||||||
| Total assets | $ | 28,272,393 | $ | 66,311,940 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Notes payable | $ | 300,664 | $ | 353,323 | ||||
| Accounts payable | 3,178,516 | 2,173,963 | ||||||
| Accrued expenses | 11,030,506 | 5,999,252 | ||||||
| Derivative liability | 39,450 | 36,868 | ||||||
| Operating lease liabilities, current | 1,436,723 | 1,280,863 | ||||||
| Current portion of long-term debt | 15,908,214 | 2,795,669 | ||||||
| Total current liabilities | 31,894,073 | 12,639,938 | ||||||
| Long-term debt, net of debt discount | — | 15,984,426 | ||||||
| Other long-term liabilities | 44,411 | 22,205 | ||||||
| Operating lease liabilities, noncurrent | 3,238,631 | 4,675,354 | ||||||
| Total liabilities | 35,177,115 | 33,321,923 | ||||||
| Stockholders’ equity | ||||||||
| Preferred stock, shares issued and outstanding at December 31, 2023 and December 31, 2022 | — | — | ||||||
| Common stock, 4,423,683 and 4,171,297 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 442 | 417 | ||||||
| Additional paid-in capital | 429,780,375 | 425,196,359 | ||||||
| Accumulated deficit | (436,683,983 | ) | (392,080,667 | ) | ||||
| Accumulated other comprehensive loss | (1,556 | ) | (126,092 | ) | ||||
| Total stockholders’ (deficit) equity | (6,904,722 | ) | 32,990,017 | |||||
| Total liabilities and stockholders’ equity | $ | 28,272,393 | $ | 66,311,940 | ||||
FAQ
What encouraging data was presented for CRB-701 at ASCO-GU 2024?
What milestone did the FDA clear for CRB-601?
When is the IND filing for CRB-913 expected?
How much cash and investments did the company have as of February 2, 2024?
Who was appointed as Chief Medical Officer in February 2024?
How much capital was raised by the company in 2024?
What was the net loss reported for the fourth quarter of 2023?
What was the total cash, cash equivalents, and investments on December 31, 2023?
What were the operating expenses for Q4 2023?
How much did the total cash, cash equivalents, and investments increase to by February 2, 2024?
