CRBP Corbus Pharmaceuticals Holdings Inc.

1.33
-0.04  -3%
Previous Close 1.37
Open 1.37
52 Week Low 0.91
52 Week High 9.78
Market Cap $166,293,898
Shares 125,033,006
Float 124,331,025
Enterprise Value $80,001,646
Volume 897,135
Av. Daily Volume 2,757,747
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Upcoming Catalysts

Drug Stage Catalyst Date
Lenabasum (Resunab)
Systemic lupus erythematosus (SLE)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Lenabasum (Resunab) - DETERMINE
Dermatomyositis
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 24, 2021.
Lenabasum (Resunab)
Cystic Fibrosis
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint - October 6, 2020.
Resunab - RESOLVE-1
Systemic Sclerosis
Phase 3
Phase 3
Phase 3 top-line data did not meet endpoints - September 8, 2020.
CRB-4001
Nonalcoholic steatohepatitis (NASH)
Phase 1
Phase 1
Phase 1 trial to commence in 2021.

Latest News

    • Study did not meet primary endpoint of Total Improvement Score (TIS) at Week 28
    • Additional findings included nominally significant improvements in TIS (p = 0.0302) and CDASI (p = 0.0166) depending on the dermatomyositis subtype
    • Lenabasum treatment was safe and well-tolerated in this study

    Norwood, MA, June 24, 2021 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), an immunology company developing innovative medicines that target inflammation, fibrosis, metabolism and immuno-oncology, today announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the rare, heterogeneous, autoimmune disease dermatomyositis.

    Primary endpoint:

    The study did not meet its primary endpoint…

    • Study did not meet primary endpoint of Total Improvement Score (TIS) at Week 28
    • Additional findings included nominally significant improvements in TIS (p = 0.0302) and CDASI (p = 0.0166) depending on the dermatomyositis subtype
    • Lenabasum treatment was safe and well-tolerated in this study

    Norwood, MA, June 24, 2021 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), an immunology company developing innovative medicines that target inflammation, fibrosis, metabolism and immuno-oncology, today announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the rare, heterogeneous, autoimmune disease dermatomyositis.

    Primary endpoint:

    The study did not meet its primary endpoint of Total Improvement Score (TIS) at Week 28. Higher TIS values indicate greater overall improvement. At Week 28, the lenabasum 20 mg twice daily group achieved a mean TIS of 28.3 versus the control group mean TIS of 26.7, p = 0.1965. All subjects, including the control group, received standard background treatments, with 89% of dosed subjects receiving ≥ 1 immunosuppressive or immunomodulating therapy. Additional pre-specified analyses of the overall effect on TIS of lenabasum 20 mg twice daily versus control group through Week 52 showed a trend of beneficial effect of lenabasum, nominal p = 0.0795.

    Additional findings:

    Dermatomyositis patients have characteristic muscle weakness and inflammatory skin involvement. This study enrolled subjects with the two major types of dermatomyositis: classic dermatomyositis with both muscle weakness and skin involvement and dermatomyositis with no significant muscle weakness but with skin involvement. Improvement in muscle weakness is heavily weighted in the TIS score. In the overall study, higher TIS scores were seen in those subjects who had muscle weakness (Manual Muscle Test-8 muscle group score < 142) and were treated with lenabasum 20 mg twice daily versus the control group, nominal p = 0.0302. Conversely, the Cutaneous Dermatomyositis Activity and Severity Index (CDASI) activity score, a secondary endpoint in this study, is a validated outcome that was designed to assess inflammatory skin involvement in dermatomyositis. In the overall study, greater improvement (reduction) in CDASI activity scores was seen in subjects with skin involvement but no muscle weakness who were treated lenabasum 20 mg twice daily versus the control group, nominal p = 0.0166. This is a similar patient population and the same endpoint as was tested in Corbus' previously completed Phase 2 study (ClinicalTrials.gov Identifier: NCT02466243).

    Effect of lenabasum on lung function was a secondary endpoint in this study, and no statistically significant difference was seen at Week 28 in the lenabasum 20 mg twice daily group versus control group. In the overall study, other pre-specified analyses showed that subjects on stable immunosuppressive therapies (> 1 year treatment duration) had an improvement in forced vital capacity compared to the control group, nominal p = 0.0591.

    Efficacy results for the lenabasum 5 mg twice daily group were generally similar to those for the control group.

    Safety:

    Safety data showed 86.5% of lenabasum-treated subjects and 85.9% of control subjects had treatment-emergent adverse events (AEs), 11.5% of lenabasum-treated subjects and 5.6% of control subjects had serious AEs, and no lenabasum-treated subject and 1 control subject discontinued study drug because of an AE related to study drug. Adverse events that occurred in ≥ 10% lenabasum-treated subjects and also in ≥ 5% more lenabasum-treated subjects than control subjects were diarrhea (12.5% versus 7.0%), dizziness (10.6% versus 4.2%), and nausea (10.6% versus 4.2%). There were fewer AEs of dermatomyositis worsening in the lenabasum 20 mg twice daily group than the control group (27 versus 44).

    Data from this study will be presented at an upcoming medical conference.

    "We are disappointed that the trial did not meet the primary endpoint of TIS at Week 28," said Barbara White, M.D., Chief Medical Officer and Head of Research at Corbus. "Nonetheless, we are encouraged by the results when the outcome is matched to the subtype of dermatomyositis in the study. We believe we see clinical activity of lenabasum 20 mg administered twice daily compared to the control group just receiving standard background treatments, with higher TIS scores in classic dermatomyositis subjects with muscle weakness and skin involvement and greater reduction in CDASI activity score in subjects with active skin disease but normal muscle strength. We thank the participants, investigators and clinical site study staff, and the patient advocacy community for their support of this study."

    Victoria Werth, M.D., Professor of Dermatology and Medicine, University of Pennsylvania Perelman School of Medicine and Chief of Dermatology, Corporal Michael J. Crescenz VAMC, said, "I'm pleased by the improvement in CDASI activity scores seen in dermatomyositis patients with minimal active muscle disease in this study. It is difficult to conduct a large stand-alone study in just this small subtype of patients. In such a complex disease, seeing this subtype with refractory skin disease respond so well in this and the Phase 2 study is promising. These patients frequently have widespread disfiguring, symptomatic and refractory skin manifestations, and there is a need for new treatments, especially those that are not immunosuppressive. Our skin biomarker data from Phase 2 show reductions in inflammatory cytokines and T cells with lenabasum treatment compared to placebo, supporting improvement in skin disease in these patients. The improvement in TIS in subjects with muscle weakness is also interesting. It is clear to me that we have to look at the organs that are involved and use outcomes that correspond to those organs to detect change in dermatomyositis."

    Yuval Cohen, Ph.D., Chief Executive Officer, commented, "We look forward to discussing the data from the Phase 2 and Phase 3 dermatomyositis studies with regulatory authorities and seeking their input on next steps. With our strong cash position, we have the resources to both advance our now diversified pipeline while also planning next steps for lenabasum."

    DETERMINE Phase 3 Study Design

    The Phase 3 trial evaluated the safety and efficacy of lenabasum in adults with active classic or amyopathic dermatomyositis who were receiving standard treatments. This international study dosed 175 subjects who were randomized 2:1:2 to receive lenabasum 20 mg twice per day (n = 69), lenabasum 5 mg twice per day (n = 35), or placebo twice per day (n = 71), all added to background treatments. The primary efficacy endpoint was the composite American College of Rheumatology/European League Against Rheumatism 2016 Total Improvement Score at Week 28, comparing lenabasum 20 mg twice daily versus placebo. Change in CDASI activity score and forced vital capacity were among secondary efficacy endpoints. As previously disclosed, in this study of up to one year duration, the timing of the primary efficacy endpoint was changed from Week 52 to Week 28.

    About Lenabasum

    Lenabasum is a novel, oral, small molecule designed to provide an alternative to immunosuppressive treatments for inflammatory or fibrotic diseases. Lenabasum binds to and activates the cannabinoid receptor type 2 (CB2), which is preferentially expressed on activated immune cells, to resolve inflammation and limit fibrosis. Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. In clinical testing to date, lenabasum has acceptable safety and tolerability profiles.

    About Dermatomyositis

    Dermatomyositis, a form of idiopathic inflammatory myositis, is a chronic, rare, inflammatory, clinically heterogenous, and sometimes life-threatening autoimmune disease affecting approximately 80,000 people in North America, EU and Japan.1 The signs and symptoms of dermatomyositis reflect multi-organ involvement, which includes distinctive skin rashes usually accompanied by proximal muscle weakness, and can also include pulmonary, cardiac, gastrointestinal, and joint involvement.2 Patients with dermatomyositis can have recurrent disease flares or chronic progressive disease activity, with increased mortality.3,4 The current mainstay of treatments include FDA-approved systemic glucocorticoids and off-label use of glucocorticoid-sparing immunosuppressive or immunomodulating agents.5,6 There is significant unmet need for new treatments to achieve disease control in dermatomyositis because of limited efficacy or toxicity of immunosuppressive agents or refractory disease.7,8

    About Corbus

    Corbus is committed to connecting innovation to our purpose of improving lives by developing new medicines that target inflammation, fibrosis, metabolism and immuno-oncology, by building upon our underlying expertise in immunology. Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on TwitterLinkedIn 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 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 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, 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 Contacts:

    Ted Jenkins, Senior Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7745

    Email:

    Lindsey Smith, Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7749

    Email:

    1. Health Advances, LLC Analysis
    2. "Dermatomyositis Information Page." National Institute of Neurological Disorders and Stroke, U.S. Department of Health and Human Services, 23 June 2021, www.ninds.nih.gov/Disorders/All-Disorders/Dermatomyositis-Information-Page
    3. Marie, Isabelle. "Morbidity and Mortality in Adult Polymyositis and Dermatomyositis." Current Rheumatology Reports, vol. 14, no. 3, 2012, pp. 275–285., doi:10.1007/s11926-012-0249-3
    4. Schiopu, Elena, et al. "Predictors of Survival in a Cohort of Patients with Polymyositis and Dermatomyositis: Effect of Corticosteroids, Methotrexate and Azathioprine." Arthritis Research & Therapy, vol. 14, no. 1, 2012, doi:10.1186/ar3704
    5. FDA label Orapred ODT, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf; accessed 23 June 2021
    6. FDA label H.P. Acthar gel, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf; accessed 23 June 2021
    7. Dalakas, Marinos C. "Immunotherapy of Myositis: Issues, Concerns and Future Prospects." Nature Reviews Rheumatology, vol. 6, no. 3, Mar. 2010, pp. 129–137., doi:10.1038/nrrheum.2010.2
    8. DeWane ME, et al. Dermatomyositis: Clinical features and pathogenesis. J Am Acad Dermatol.



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    • Corbus diversifies pipeline with two new mAbs that target integrins that inhibit activation of TGFβ
    • High potency anti-αvβ8 mAb licensed from University of California San Francisco and
      anti-αvβ6/αvβ8 mAb licensed from Panorama Research Inc.
    • Both mAbs expected to start Phase 1 testing in 2022
    • Capital and resources in place to advance multiple programs into clinical development
    • Company to host conference call and webcast today, Tuesday, June 1, 2021 at 8:30 a.m. ET

    Norwood, MA, June 01, 2021 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), today announced licensing deals for two new monoclonal antibodies (mAbs), CRB-601 and CRB-602, that target integrins to inhibit activation of transforming growth…

    • Corbus diversifies pipeline with two new mAbs that target integrins that inhibit activation of TGFβ
    • High potency anti-αvβ8 mAb licensed from University of California San Francisco and

      anti-αvβ6/αvβ8 mAb licensed from Panorama Research Inc.
    • Both mAbs expected to start Phase 1 testing in 2022
    • Capital and resources in place to advance multiple programs into clinical development
    • Company to host conference call and webcast today, Tuesday, June 1, 2021 at 8:30 a.m. ET

    Norwood, MA, June 01, 2021 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) ("Corbus" or the "Company"), today announced licensing deals for two new monoclonal antibodies (mAbs), CRB-601 and CRB-602, that target integrins to inhibit activation of transforming growth factor β (TGFβ). This new integrin program, in addition to the existing endocannabinoid system program, strengthens and diversifies Corbus' immunology pipeline for inflammatory, fibrotic, and metabolic diseases, and cancer. With these additions, Corbus expects to have four compounds other than lenabasum in Phase 1 testing in 2022.

    Targeting integrins to inhibit TGFβ activation

    TGFβ is a multifunctional cytokine involved in many cellular processes, including cell growth and differentiation, immune responses, wound healing, and tissue repair. TGFβ plays a key role in fibrosis and also promotes cancer growth and metastasis via its effects in the tumor microenvironment (TME). The integrins αvβ6 and αvβ8 are expressed by cancer cells, and αvβ6 is also expressed on epithelial cells in fibrotic diseases. These integrins enable TGFβ to exert its biologic effects by releasing it from its latent complex. The goal of blocking these integrins is to inhibit the deleterious effects of TGFβ. A number of other preclinical and early clinical stage programs are testing this approach of inhibiting αv integrins.

    CRB-601 and CRB-602 are two novel and distinct anti-integrin mAbs:

    • CRB-601 is an anti-αvβ8 mAb rationally designed by Dr. Stephen Nishimura and his colleagues at the University of California San Francisco and is potent at picomolar concentrations in inhibiting activation of TGFβ. C6D4, the parent mAb of CRB-601, has single agent activity as well as synergistic activity when combined with an anti-PD1 mAb in syngeneic mouse tumor models. Corbus plans to develop CRB-601 for treatment of solid tumors in combination with existing therapies, including checkpoint inhibitors. Phase 1 studies are expected to start in 2022.
    • CRB-602 was developed by Panorama Research Inc. to specifically inhibit both αvβ6 and αvβ8. Both αvβ6 and αvβ8 have been implicated in fibrotic diseases and in cancers of epithelial cell origin. Corbus believes targeting both integrins at once is a rational approach to treating fibrotic diseases and carcinomas. Phase 1 studies are expected to start in 2022.

    "We look forward to a strong partnership with Corbus and hope to see our mAb make a positive impact on the lives of cancer patients all over the world," said Anthony Francis, Executive Director of Technology Management at UCSF Innovation Ventures.

    "Corbus is committed to developing new medicines to improve the lives of people who need them," stated Yuval Cohen, Ph.D., Chief Executive Officer. "We believe these two new integrin-targeting mAbs offer a promising approach to inhibiting TGFβ, fit well with our expertise in immunology, and diversify and expand our pipeline. We plan to advance up to four new programs into the clinic next year and have the capital and resources to do so." 

    The Company's $125 million of cash and investments on hand, as of March 31, 2021, is expected to fund operations into the first quarter of 2024, based on the current planned expenditures. 

    Transactions Terms and Conditions:

    Under the combined terms of the two exclusive licensing agreements, Corbus will pay $2,000,000 upfront and will make potential development and sales milestone payments totaling up to $206,000,000 and pay low single-digit royalties on sales.

    Conference Call and Webcast Information:

    Corbus management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Tuesday, June 1, 2021, 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.

    About UCSF

    The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes UCSF Health, which comprises three top-ranked hospitals, as well as affiliations throughout the Bay Area. Learn more at ucsf.eduor see our Fact Sheet.

    About Panorama Research Inc.

    Panorama Research Inc. is a translational research lab and incubator with deep domain expertise in antibody engineering and preclinical drug development. Panorama focuses on identifying promising therapeutic targets and incubates novel, proprietary technologies from in-house research or through collaboration with leading academic institutions. Panorama is headquartered in Sunnyvale, CA.

    About Corbus

    Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on TwitterLinkedIn 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 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 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, 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.

    UCSF Contact:

    Ellen Kats, Assistant Director, Business Development & Licensing

    Email:

    Corbus Pharmaceuticals Contacts:

    Ted Jenkins, Senior Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7745

    Email:

    Lindsey Smith, Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7749

    Email:



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  1. Norwood, MA, May 25, 2021 (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, today announced the publication of two abstracts at the European League Against Rheumatism (EULAR) 2021 Virtual Congress that will be taking place June 2-5, 2021.

    Details of the presentations are as follows:

    Presentation Title: Phase 3 Trial of Lenabasum, a CB2 Agonist, for the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc)
    Session: Progress in myositis and scleroderma research - I
    Date: Thursday, June 3, 2021
    Presentation Time: 10:25 a.m. - 10:32 a.m. CEST (4:25 a.m. – 4:32 a.m. EDT…

    Norwood, MA, May 25, 2021 (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, today announced the publication of two abstracts at the European League Against Rheumatism (EULAR) 2021 Virtual Congress that will be taking place June 2-5, 2021.

    Details of the presentations are as follows:

    Presentation Title: Phase 3 Trial of Lenabasum, a CB2 Agonist, for the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc)

    Session: Progress in myositis and scleroderma research - I

    Date: Thursday, June 3, 2021

    Presentation Time: 10:25 a.m. - 10:32 a.m. CEST (4:25 a.m. – 4:32 a.m. EDT)

    Presenter: Robert Spiera, M.D., Director of the Scleroderma, Vasculitis, and Myositis Program at the Hospital for Special Surgery, Weill Cornell Medical College and Co-Principal Investigator of Corbus' Phase 3 RESOLVE-1 study in systemic sclerosis

    Abstract Number: OP0171

    Poster TitleLong-term Safety and Efficacy of Lenabasum during 3 Years in an Open-Label Extension (OLE) of a Phase 2 Study of Lenabasum in Refractory Skin Disease in Dermatomyositis (DM)

    Session: Scleroderma, myositis and related syndromes

    Date: Saturday, June 5, 2021

    Presentation Time: 10:30 a.m. - 10:36 a.m. CEST (4:30 a.m. – 4:36 a.m. EDT)

    Presenter: Victoria Werth, M.D., Professor of Dermatology and Medicine at the University of Pennsylvania Perelman School of Medicine and Co-Principal Investigator of Corbus' Phase 3 DETERMINE study in dermatomyositis

    Abstract Number: POS0315

    The abstracts are published in the EULAR 2021 Abstract Archive on the conference website. EULAR presentations are under embargo until 00:01 GMT+1 on June 2, 2021. Once the presentations are made public, they will be available on the Company's website in the Scientific Conferences section.

    About Lenabasum

    Lenabasum is a novel, oral, small molecule designed to provide an alternative to immunosuppressive treatments for inflammatory or fibrotic diseases. Lenabasum binds to and activates the cannabinoid receptor type 2 (CB2), which is preferentially expressed on activated immune cells, to resolve inflammation and limit fibrosis. Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. In clinical testing to date, lenabasum has acceptable safety and tolerability profiles without evidence of immunosuppression.

    About Corbus 

    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.

    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 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 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, 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 Contacts:

    Ted Jenkins, Senior Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7745

    Email:

    Lindsey Smith, Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7749

    Email:



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  2. Norwood, MA, May 19, 2021 (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, today announced that it has adjourned its 2021 Annual Meeting of Stockholders (the "Annual Meeting") in order to provide stockholders additional time within which to vote on all proposals, including Proposal 4 to approve an amendment to the Company's certificate of incorporation to increase the Company's authorized shares of common stock from 150,000,000 to 300,000,000.

    The Company believes there is significant support for Proposal 4. At the time of the Annual Meeting, approximately 85% of the…

    Norwood, MA, May 19, 2021 (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, today announced that it has adjourned its 2021 Annual Meeting of Stockholders (the "Annual Meeting") in order to provide stockholders additional time within which to vote on all proposals, including Proposal 4 to approve an amendment to the Company's certificate of incorporation to increase the Company's authorized shares of common stock from 150,000,000 to 300,000,000.

    The Company believes there is significant support for Proposal 4. At the time of the Annual Meeting, approximately 85% of the votes cast on Proposal 4 were voted in favor of its approval. Because Proposal 4 must be approved by a majority of the outstanding shares of common stock, however, it has not yet received a sufficient number of votes in its favor. Because Corbus' Board of Directors continues to believe that Proposal 4 is advisable and in the best interests of the Company's stockholders to consider and act upon Proposal 4, the Company adjourned the Annual Meeting.

    The adjourned meeting will be held at 9:00 a.m. ET on Thursday, June 17, 2021 at the following url: www.viewproxy.com/corbuspharma/2021/vm. The record date for the annual meeting is March 31, 2021.

    About Corbus

    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 TwitterLinkedIn, and Facebook.

    Corbus Pharmaceuticals Contacts:

    Ted Jenkins, Senior Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7745

    Email: 

    Lindsey Smith, Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7749

    Email: 



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    • Phase 3 study of lenabasum in dermatomyositis on schedule for topline data in Q2 2021
    • Company focused on advancing cannabinoid programs in metabolic diseases and cancer into the clinic in 2022
    • Corbus is actively engaging with potential partners to expand its pipeline through acquisition of external assets
    • Cash and investments on hand of $125M provides projected runway into Q1 2024

    Norwood, MA, May 13, 2021 (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, today reported financial results for the first quarter of 2021 and provided corporate updates.

    Pipeline Updates:

    • Phase 3 study of lenabasum in dermatomyositis on schedule for topline data in Q2 2021
    • Company focused on advancing cannabinoid programs in metabolic diseases and cancer into the clinic in 2022
    • Corbus is actively engaging with potential partners to expand its pipeline through acquisition of external assets
    • Cash and investments on hand of $125M provides projected runway into Q1 2024

    Norwood, MA, May 13, 2021 (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, today reported financial results for the first quarter of 2021 and provided corporate updates.

    Pipeline Updates:

    • Lenabasum, a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist:
      • Dermatomyositis: The last subject completed the final visit in the Phase 3 "DETERMINE" study on March 30, 2021. Topline data are on schedule for Q2 2021. 
      • Systemic lupus erythematosus: The last subject was enrolled in the National Institutes of Health-sponsored Phase 2 study on April 20, 2021. Topline data are expected in the second half of 2021. 
    • Cannabinoid receptor type 1 (CB1) inverse agonists for metabolic diseases: 
      • Corbus compounds promote weight loss and improve glucose tolerance and insulin sensitivity in a preclinical model of diet-induced obesity. Corbus is moving toward candidate selection and first-in-human clinical studies in 2022.
    • CB2 agonists for cancer:
      • Multiple Corbus compounds have demonstrated activity against tumor cells in vitro, and several show activity as monotherapy in animal models of solid tumors. The Company plans candidate selection later this year and first-in-human clinical studies in 2022. 

    Yuval Cohen, Ph.D., Chief Executive Officer said, "We are making progress on our plan to expand our pipeline with our internal cannabinoid programs as well as actively engaging with potential partners to add new assets."

    Dr. Cohen continued, "We benefit from a strong financial position with approximately $125M of cash and investments on hand, which is expected to fund the Company into the first quarter of 2024."

    Financial Results for First Quarter Ended March 31, 2021:

    Revenue from awards and licenses was approximately $648,000 for the three months ended March 31, 2021, compared to approximately $1.8 million in the comparable period in 2020.

    Operating expenses decreased by $15.5 million to approximately $16.1 million for the three months ended March 31, 2021, compared to $31.6 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

    The Company reported a net loss of approximately $16.1 million, or a net loss per diluted share of $0.14, for the three months ended March 31, 2021, compared to a net loss of approximately $29.7 million, or a net loss per diluted share of $0.43, for the same period in 2020.

    Cash, cash equivalents and investments were $125 million as of March 31, 2021. During the first quarter of 2021, the Company raised $58.9 million in net proceeds from the Company's ATM facility.

    The $125 million of cash and investments on hand, as of March 31, 2021, is expected to fund operations into the first quarter of 2024, based on the current planned expenditures.

    About Corbus 

    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.

    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 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 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, 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

      March 31,  December 31, 
      2021 (unaudited)  2020 
    ASSETS        
    Current assets:        
    Cash and cash equivalents $66,613,246  $85,433,441 
    Marketable Securities  57,399,179    
    Restricted cash  350,000   350,000 
    Stock subscriptions receivable     960,033 
    Prepaid expenses and other current assets  3,658,794   3,712,861 
    Contract asset  2,266,120   1,618,296 
    Total current assets  130,287,339   92,074,631 
    Restricted cash  669,900   669,900 
    Property and equipment, net  3,787,596   4,067,837 
    Operating lease right of use asset  5,096,165   5,248,525 
    Other assets  304,037   234,038 
    Total assets $140,145,037  $102,294,931 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
    Notes payable $408,278  $710,158 
    Accounts payable  3,615,366   7,381,183 
    Accrued expenses  17,742,474   22,005,432 
    Derivative liability  803,000   797,000 
    Operating lease liabilities, current  1,036,297   1,004,063 
    Total current liabilities  23,605,415   31,897,836 
    Long-term debt, net of debt discount  18,199,289   18,029,005 
    Operating lease liabilities, noncurrent  6,823,339   7,093,165 
    Total liabilities  48,628,043   57,020,006 
    Stockholders' equity        
    Preferred Stock $0.0001 par value: 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2021 and December 31, 2020      
    Common stock, $0.0001 par value; 150,000,000 shares authorized, 125,033,006 and 98,852,696 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively  12,503   9,885 
    Additional paid-in capital  411,691,762   349,358,378 
    Accumulated other comprehensive loss  (28,765)   
    Accumulated deficit  (320,158,506)  (304,093,338)
    Total stockholders' equity  91,516,994   45,274,925 
    Total liabilities and stockholders' equity $140,145,037  $102,294,931 

    Corbus Pharmaceuticals Holdings, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

      For the Three Months Ended 
      March 31, 
      2021  2020 
    Revenue from awards and licenses $647,824  $1,762,059 
    Operating expenses:        
    Research and development  10,720,823   23,947,866 
    General and administrative  5,341,197   7,699,479 
    Total operating expenses  16,062,020   31,647,345 
    Operating loss  (15,414,196)  (29,885,286)
    Other income (expense), net:        
    Other income (expense), net  (15,094)  - 
    Interest income (expense), net  (646,550)  101,993 
    Change in fair value of derivative liability  (6,000)  - 
    Foreign currency exchange loss, net  16,672   126,493 
    Other income (expense), net  (650,972)  228,486 
    Net loss $(16,065,168) $(29,656,800)
    Net loss per share, basic and diluted $(0.14) $(0.43)
    Weighted average number of common shares outstanding, basic and diluted  116,344,900   69,272,402 

    Corbus Pharmaceuticals Contacts:

    Ted Jenkins, Senior Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7745

    Email:

    Lindsey Smith, Director, Investor Relations and Corporate Communications

    Phone: +1 (617) 415-7749

    Email:



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