Full Press Release Details
Pharmaceuticals Reports Third Quarter Financial Results and Provides Corporate Updates
| Company intends to shorten fully-enrolled Phase 3 dermatomyositis trial to 28 weeks from 52 weeks following recent developments in competitive landscape; data now expected as early as the second quarter of 2021 | ||
| Expected cash runway extended into second quarter of 2022 as a result of Company restructuring, with potential to extend cash runway even further due to shortening of Phase 3 dermatomyositis trial | ||
| Company will also focus on progressing pipeline compounds toward clinical testing | ||
| Reported topline data from RESOLVE-1 Phase 3 study of lenabasum in systemic sclerosis and data from Phase 2b study of lenabasum in cystic fibrosis; Corbus is exploring potential next steps in both indications | ||
| Company to host conference call and webcast today, Tuesday, November 10, 2020 at 8:30 a.m. ET |
MA, November 10, 2020 (GLOBE NEWSWIRE) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: 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.
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."
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."
a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist
- The Phase 3 "DETERMINE" study in dermatomyositis, a rare and life-threatening
autoimmune disease characterized by skin and muscle inflammation, is fully enrolled.
| This double-blind, randomized, placebo-controlled, multinational study enrolled 176 patients, which exceeded the original target of 150 patients. Approximately 60% of patients have completed Week 28 of dosing. | ||
| There have been recent changes in the dermatomyositis competitive landscape with studies that are shorter than one year using the same efficacy endpoint as D ETER M INE. Therefore, Corbus will submit a protocol amendment to the FDA and other regulatory agencies to shorten the treatment duration of D ETER M INE to 28 weeks from one year. The last subject visit through 28 weeks is expected in March 2021 with topline data to be reported shortly thereafter. | ||
| Baseline patient demographics and disease characteristics were presented at the American College of Rheumatology's (ACR) Convergence 2020, which took place November 5-9, 2020. ACR poster is available online . | ||
| A separate presentation at ACR Convergence 2020 showed that CB2 expression was increased on immune cells in lesional skin from dermatomyositis subjects in the lenabasum Phase 2 study. Treatment with lenabasum was associated with reduction in immune cell infiltrates, CB2 expression and inflammatory cytokine production in lesional skin from these subjects. ACR poster is available online . | ||
| There is significant unmet need for new medicines to achieve disease control in dermatomyositis because of the limitations of current treatment options. Dermatomyositis affects approximately 80,000 people in North America, EU and Japan. |
| Topline data remain as previously reported. | ||
| Exploratory post -hoc analyses showed lenabasum treatment was associated with a benefit in lung function (forced vital capacity) in subjects on established background immunosuppressant therapies (greater than 2 years) | ||
| Focusing on FVC in patients on established immunosuppressant therapies could address a key unmet need, which Corbus believes represent a potential commercial opportunity. | ||
| Systemic sclerosis is a rare, life-threatening autoimmune disease affecting up to 75K Americans. |
| Topline data remain as previously reported. | ||
| Lenabasum did not meet its primary efficacy endpoint in the study. | ||
| Lenabasum was well tolerated with no new safety findings. | ||
| Exploratory post-hoc analyses revealed unexpectedly low PEx rates in subjects from five eastern European countries (21% of total subjects) who received placebo. Pulmonary exacerbations rates in these subjects were 85% lower than in subjects from other countries. | ||
| Exploratory post-hoc analyses in subjects with similar FEV1% predicted at baseline and similar treatment with CFTR-modulators suggested evidence of clinical benefit of lenabasum. | ||
| PEx remains a significant burden in people with CF even with current standard therapies, including antibiotics and CFTR modulators. |
Results for Third Quarter Ended September 30, 2020:
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
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.
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.
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.
Call and Webcast Information:
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.
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
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.
is not approved for the treatment of any indication. For more information on Corbus' clinical programs, please visit here.
more information, visit http://www.corbuspharma.com/, and connect with us on Twitter, LinkedIn, and Facebook.
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.
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.
Pharmaceuticals Holdings, Inc.
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 |
Pharmaceuticals Holdings, Inc.
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 |
Pharmaceuticals Contacts:
Jenkins, Senior Director, Investor Relations and Corporate Communications
Smith, Director, Investor Relations and Corporate Communications