Norwood, MA, Nov 10, 2020 (GLOBE NEWSWIRE via COMTEX) -- Corbus Pharmaceuticals Holdings, Inc. (NAS:CRBP) ("Corbus" or the "Company"), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system ("ECS"), today reported financial results for the third quarter of 2020. The Company also provided clinical, pipeline and corporate updates.
Yuval Cohen, Ph.D., Chief Executive Officer said, "We are emerging from a very challenging period with a continued focus on our lenabasum dermatomyositis program and preclinical pipeline. Our restructuring significantly improved our cash runway, so we can continue to work toward delivering a much-needed novel therapeutic option for patients while also giving us the resources to look at external assets that will be synergistic to our in-house capabilities. We expect our cash runway to be further extended with the cost savings from our plan to shorten the DETERMINE Phase 3 dermatomyositis study to 28 weeks from one year. This decision is driven by recent changes in the dermatomyositis competitive landscape and will accelerate topline data readout to the second quarter of 2021. We see our dermatomyositis program as a potential large value driver for our Company, given that there are about 40,000 dermatomyositis patients in North America and limitations with current treatment options."
Dr. Cohen continued, "While we were disappointed that both the RESOLVE-1 systemic sclerosis study and the Phase 2b cystic fibrosis study did not meet their primary endpoints, we have a solid understanding of what led to those outcomes. The data generated point to clinical activity associated with lenabasum treatment. The dataset also provided unique insight into disease progression and the impact of current standards of care. With this in mind, we are working with systemic sclerosis and cystic fibrosis experts to further analyze the data and potentially explore paths forward in these programs."
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist
Dermatomyositis - The Phase 3 "DETERMINE" study in dermatomyositis, a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, is fully enrolled.
Financial Results for Third Quarter Ended September 30, 2020:
For the quarter ended September 30, 2020, the Company reported a net loss of approximately $34.9 million or a net loss per diluted share of $0.43, compared to a net loss of approximately $20.8 million or net loss per diluted share of $0.32 for the quarter ended September 30, 2019.
For the quarter ended September 30, 2020, revenue decreased by approximately $1.4 million from the third quarter of 2019 to $1.2 million, due primarily to revenue recognized under the Cystic Fibrosis Program Related Investment Agreement.
Operating expenses for the quarter ended September 30, 2020 increased by approximately $7.5 million to $35.2 million. The increase was primarily attributable to increased clinical trial costs.
Corbus expects its cash and cash equivalents on hand of approximately $81.9 million at September 30, 2020 together with proceeds from the expected final $2.5 million milestone payment from the Cystic Fibrosis Foundation and anticipated foreign tax credits to fund operations and its current clinical plan beyond the second quarter of 2022.
Conference Call and Webcast Information:
Corbus management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Tuesday, November 10, 2020, at 8:30 a.m. ET.
To participate on the call, please dial (877) 407-3978 (domestic) or (412) 902-0039 (international). The live webcast will be accessible on the Events page of the Investors section of the Corbus website, www.corbuspharma.com , and will be archived for 90 days.
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on the development and commercialization of novel medicines designed to target the endocannabinoid system. The Company's lead product candidate, lenabasum, is a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to provide an alternative to immunosuppressive medications in the treatment of chronic inflammatory and fibrotic diseases. Lenabasum is currently being evaluated in dermatomyositis and systemic lupus erythematosus. Corbus is also developing a pipeline of other preclinical drug candidates from its endocannabinoid system platform.
Lenabasum is not approved for the treatment of any indication. For more information on Corbus' clinical programs, please visit here.
For more information, visit http://www.corbuspharma.com/ , and connect with us on Twitter, LinkedIn, and Facebook.
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 restructuring, 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 statements 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, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, 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.
Corbus Pharmaceuticals Holdings, Inc.
Condensed Consolidated Balance Sheets
September 30, December 31, 2020 2019 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 81,870,651 $ 31,748,686 Restricted cash 350,000 -- Prepaid expenses and other current assets 2,177,383 3,724,932 Contract asset 960,091 2,681,065 Total current assets 85,358,125 38,154,683 Restricted cash 669,900 -- Property and equipment, net 4,402,022 5,083,865 Operating lease right of use asset 5,396,248 5,818,983 Other assets 13,041 84,968 Total assets $ 95,839,336 $ 49,142,499 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Notes payable $ -- $ 752,659 Accounts payable 11,080,717 11,091,363 Accrued expenses 28,593,049 22,447,939 Derivative liability 757,000 -- Operating lease liabilities, current 972,464 595,745 Total current liabilities 41,403,230 34,887,706 Long-term debt, net of debt discount 17,856,589 -- Operating lease liabilities, noncurrent 7,353,765 8,097,228 Total liabilities $ 66,613,584 $ 42,984,934 Stockholders' equity Preferred Stock $0.0001 par value:10,000,000 shares authorized, no shares issued and outstanding at September 30, 2020 and December 31, 2019 -- -- Common stock, $0.0001 par value; 150,000,000 shares authorized, 82,207,405 and 64,672,893 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 8,220 6,467 Additional paid-in capital 324,698,962 198,975,056 Accumulated deficit (295,481,430 ) (192,823,958 ) Total stockholders' equity 29,225,752 6,157,565 Total liabilities and stockholders' equity $ 95,839,336 $ 49,142,499
Corbus Pharmaceuticals Holdings, Inc.
Consolidated Statements of Operations
For the Three Months Ended For the Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Revenue from awards and licenses $ 1,230,621 $ 2,589,783 $ 3,279,026 $ 33,570,048 Operating expenses: Research and development 27,522,989 22,152,001 82,156,926 66,117,114 General and administrative 7,681,573 5,534,493 23,120,020 17,367,202 Total operating expenses 35,204,562 27,686,494 105,276,946 83,484,316 Operating loss (33,973,941 ) (25,096,711 ) (101,997,920 ) (49,914,268 ) Other income (expense), net: Other income (expense), net (4,972 ) 4,109,338 4,005 4,109,338 Interest income (expense), net (454,319 ) 292,854 (348,654 ) 1,076,166 Change in fair value of derivative liability (211,000 ) - (211,000 ) - Foreign currency exchange loss, net (251,117 ) (96,282 ) (103,903 ) (144,193 ) Other income (expense), net (921,408 ) 4,305,910 (659,552 ) 5,041,311 Net loss $ (34,895,349 ) $ (20,790,801 ) $ (102,657,472 ) $ (44,872,957 ) Net loss per share, basic and diluted $ (0.43 ) $ (0.32 ) $ (1.37 ) $ (0.71 ) Weighted average number of common shares outstanding, basic and diluted 81,879,119 64,660,017 75,037,418 63,638,447
Corbus Pharmaceuticals Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7745
Lindsey Smith, Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7749
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