CRBP Corbus Pharmaceuticals Holdings Inc.

1.59
-0.08  -5%
Previous Close 1.67
Open 1.64
52 Week Low 0.91
52 Week High 9.78
Market Cap $198,802,480
Shares 125,033,006
Float 124,331,025
Enterprise Value $150,208,070
Volume 2,016,955
Av. Daily Volume 3,812,967
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Upcoming Catalysts

Drug Stage Catalyst Date
Lenabasum (resunab) - DETERMINE
Dermatomyositis
Phase 3
Phase 3
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Lenabasum (Resunab)
Systemic lupus erythematosus (SLE)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Lenabasum
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

    • 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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  1. Norwood, MA, May 11, 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 Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will be presenting at three upcoming virtual investor conferences.

    The following are the details for the conferences:

    2021 RBC Capital Markets Global Healthcare Conference

    • Event: Fireside Chat Discussion and Q&A
    • Date and Time: Tuesday, May 18, 2021, at 3:40pm EST

    Oppenheimer Rare & Orphan Disease Summit

    • Event: Fireside Chat Discussion and Q&A
    • Date and Time: Friday, May 21, 2021, at 9:55am EST

    Jefferies

    Norwood, MA, May 11, 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 Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will be presenting at three upcoming virtual investor conferences.

    The following are the details for the conferences:

    2021 RBC Capital Markets Global Healthcare Conference

    • Event: Fireside Chat Discussion and Q&A
    • Date and Time: Tuesday, May 18, 2021, at 3:40pm EST

    Oppenheimer Rare & Orphan Disease Summit

    • Event: Fireside Chat Discussion and Q&A
    • Date and Time: Friday, May 21, 2021, at 9:55am EST

    Jefferies Virtual Global Healthcare Conference

    • Event: Fireside Chat Discussion and Q&A
    • Date and Time: Tuesday, June 1, 2021, at 10:30am EST

    An audio webcast of the presentations will be accessible on the Events page of the Investors section of the Corbus website, www.corbuspharma.com. Replays will be available approximately one hour after each event and will be archived for 90 days following the event.

    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 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 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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    • First study to explore potential benefit of a cannabinoid receptor type 2 agonist in SLE
    • Study sponsored and funded by the Nastional Institute of Allergy and Infectious Diseases through the Autoimmunity Centers of Excellence (ACE) Cooperative Network
    • Topline data expected in the second half of 2021
    • SLE is a serious autoimmune disease with multi-organ involvement and affects more than 200,000 Americans

    Norwood, MA, April 20, 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 the last participant was enrolled in a Phase 2 study of lenabasum for the treatment…

    • First study to explore potential benefit of a cannabinoid receptor type 2 agonist in SLE
    • Study sponsored and funded by the Nastional Institute of Allergy and Infectious Diseases through the Autoimmunity Centers of Excellence (ACE) Cooperative Network
    • Topline data expected in the second half of 2021
    • SLE is a serious autoimmune disease with multi-organ involvement and affects more than 200,000 Americans

    Norwood, MA, April 20, 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 the last participant was enrolled in a Phase 2 study of lenabasum for the treatment of systemic lupus erythematosus (SLE).

    The 16-week, U.S., multi-center, first-in-patient, exploratory clinical trial enrolled 101 participants to evaluate the safety, efficacy, and tolerability of lenabasum in adults with SLE who are receiving standard treatments, including background immunosuppressive therapies. This study is the first randomized, double-blind, placebo-controlled study targeting the potential role of the cannabinoid receptor type 2 in SLE. Patients in the study are randomized 1:1:1:1 to either receive lenabasum 20 mg twice daily, lenabasum 20 mg once daily, lenabasum 5 mg twice daily, or placebo.

    The primary efficacy endpoint is change from baseline in the 7-day average of the maximum daily Numerical Rating Scale-Pain score at Week 12. Secondary efficacy assessments include other evaluations of musculoskeletal pain and disease activity, SLE Responder Index, SELENA-SLEDAI score, BILAG-2004 score, Physician Global Assessment, Lupus Activity Patient Global Assessment, and PROMISE-29 scores. Various biomarkers will also be measured.

    The clinical trial (ClinicalTrials.gov identifier: NCT03093402) is led by principal investigator, Meggan Mackay, M.D., professor at the Feinstein Institutes for Medical Research, and is sponsored and funded (UM1AI110494) by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Topline results from the study are expected in the second half of 2021.

    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 Systemic Lupus Erythematosus

    Systemic lupus erythematosus (SLE), a form of lupus, is a systemic autoimmune disease affecting more than 200,000 Americans.1,2 SLE occurs when the immune system is activated and attacks different parts of the body, leading to widespread inflammation that can affect many different body parts, including a person's joints, skin, kidneys, blood cells, brain, heart, and lungs.2,3

    Each person with SLE has slightly different symptoms that can range from mild to severe, depending on which body parts are affected by the disease.2 Symptoms may include arthritis, extreme fatigue, red rashes, hair loss, sensitivity to the sun, mouth sores, and pale or purple fingers and toes when exposed to cold or stress.2

    Although SLE is most often a disease that one can live with for decades, it is ranked among the top 20 leading causes of death in young women.4 Medicines specifically approved by the FDA for treatment of SLE are aspirin, hydroxychloroquine, corticosteroids (for example, prednisone), a repository corticotropin injection, and the immunosuppressive drug belimumab.2 Other drugs that are not FDA-approved for SLE but are often prescribed by physicians include methotrexate, mycophenolate, azathioprine and cyclophosphamide. These treatments may be associated with significant side effects, including serious infections.

    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.

    About the Feinstein Institutes

    The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.

    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 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 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: 

    Feinstein Institutes for Medical Research Contact:

    Matthew Libassi, Lead Media Relations Specialist

    Phone: +1 (631) 793-5325

    Email: 

    1. Izmirly, et al ."Prevalence of Systemic Lupus Erythematosus in the United States: Estimates from a Meta‐Analysis of the Centers for Disease Control and Prevention National Lupus Registries." Arthritis & Rheumatology, https://doi.org/10.1002/art.41632

    2. "Lupus." Mayo Clinic, Mayo Clinic, 24 March 2021, www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789

    3. "Systemic Lupus Erythematosus (Lupus)." National Institute of Arthritis and Musculoskeletal and Skin Diseases, U.S. Department of Health and Human Services, 24 March 2021, www.niams.nih.gov/health-topics/lupus/advanced#tab-symptoms

    4. Yen, et al. "Brief Report: Lupus-An Unrecognized Leading Cause of Death in Young Females: A Population-Based Study Using Nationwide Death Certificates, 2000-2015." Arthritis & Rheumatology, doi:10.1002/art.40512



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    • Topline data on schedule for Q2 2021
    • Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, and affects ~80,000 people in North America, EU, and Japan
    • There is a significant need for safer and more effective treatments in dermatomyositis because of limitations of current treatment options

    Norwood, MA, March 30, 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 the last subject completed the final visit in the double-blind, placebo-controlled part of the Company's Phase 3 DETERMINE study of lenabasum…

    • Topline data on schedule for Q2 2021
    • Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, and affects ~80,000 people in North America, EU, and Japan
    • There is a significant need for safer and more effective treatments in dermatomyositis because of limitations of current treatment options

    Norwood, MA, March 30, 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 the last subject completed the final visit in the double-blind, placebo-controlled part of the Company's Phase 3 DETERMINE study of lenabasum for the treatment of dermatomyositis. The open-label extension of the study is ongoing. Topline results from the study are on track to be reported in the second quarter of 2021.

    The Phase 3 trial is an international, 176-subject study evaluating the safety and efficacy of lenabasum in adult dermatomyositis patients who are receiving standard treatments, including background immunosuppressive therapies. This study is the largest randomized, double-blind, placebo-controlled dermatomyositis study to date. Subjects were randomized 2:1:2 to either receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day.

    The primary efficacy endpoint is the composite American College of Rheumatology/European League Against Rheumatism 2016 Total Improvement Score ("Total Improvement Score") at Week 28. Change from baseline will be provided for each component of the Total Improvement Score to support this composite endpoint. Definition of Improvement, Investigator Global Assessment scale of skin activity, and Cutaneous Dermatomyositis Activity and Severity Index activity score are among secondary efficacy endpoints.

    Lenabasum was granted Orphan Drug Designation for the treatment of dermatomyositis from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

    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 an acceptable safety and tolerability profiles without evidence of immunosuppression.

    About Dermatomyositis

    Dermatomyositis (DM), a form of myositis, is a chronic, rare, inflammatory, clinically heterogenous, life-threatening autoimmune disease affecting approximately 80,000 people in North America, EU and Japan.1 The signs and symptoms of DM 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 DM 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, adrenocorticotropic hormone analogue and off-label use of glucocorticoid-sparing immunosuppressive agents.5,6 There is significant unmet need for new treatments to achieve disease control in DM because of limited efficacy or toxicity of immunosuppressive agents or refractory disease.7,8

    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 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: 

    1. Health Advances, LLC Analysis
    2. "Dermatomyositis Information Page." National Institute of Neurological Disorders and Stroke, U.S. Department of Health and Human Services, 26 March 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, availableat https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf; accessed 26 March 2021
    6. FDA label H.P. Acthar gel, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf; accessed 26 March 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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  2.  Phase 3 study of lenabasum in dermatomyositis on schedule for topline data in Q2 2021
     Company focused on advancing in-house programs in metabolic diseases, fibrotic disorders, and cancer with clinical studies projected for 2022
     Corbus is actively engaging with potential partners to expand its pipeline through acquisition of external assets
     Cash on hand of $127M, projected runway into 2024
     Company to host conference call and webcast today, Monday, March 15th at 8:30 a.m. ET

    Norwood, MA, March 15, 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…

     Phase 3 study of lenabasum in dermatomyositis on schedule for topline data in Q2 2021
     Company focused on advancing in-house programs in metabolic diseases, fibrotic disorders, and cancer with clinical studies projected for 2022
     Corbus is actively engaging with potential partners to expand its pipeline through acquisition of external assets
     Cash on hand of $127M, projected runway into 2024
     Company to host conference call and webcast today, Monday, March 15th at 8:30 a.m. ET

    Norwood, MA, March 15, 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 fourth quarter and year-end 2020. The Company also provided clinical and pipeline updates.

    Yuval Cohen, Ph.D., Chief Executive Officer said, "We are making progress on our plans to advance development of our internal compounds and expand our pipeline. We look forward to topline results from our DETERMINE Phase 3 study of lenabasum in dermatomyositis in the second quarter. Our CB1 inverse agonist program focusing on metabolic diseases and our CB2 agonist program focusing on oncology continue to progress pre-clinically, and we project to initiate clinical studies next year. We are determined to expand our pipeline and are evaluating a number of potential assets."

    Dr. Cohen continued, "We are fortunate to be in a strong financial position with approximately $127M of cash on hand, which is expected to fund the Company into the first quarter of 2024."

    Clinical Program Updates:

    Lenabasum: a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist

     Dermatomyositis – The Phase 3 "DETERMINE" study is a double-blind, randomized, placebo-controlled, international study of safety and efficacy of lenabasum in adult dermatomyositis patients. This study enrolled 176 subjects, and all subjects are expected to complete Week 28 of the study this month. The primary efficacy endpoint is Total Improvement Score at Week 28, comparing lenabasum 20 mg twice per day and placebo groups. Topline data are on schedule for Q2 2021.
       
      Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation. Dermatomyositis affects approximately 80,000 people in North America, EU, and Japan. There is a significant unmet need for safer and more effective treatments in dermatomyositis because of the limitations of current treatment options.
       
     Systemic Lupus Erythematosus – This Phase 2b study is a double-blind, randomized, placebo-controlled, U.S.-based study of safety and efficacy of lenabasum in adult systemic lupus erythematosus patients. The ongoing study is expected to dose 100 subjects at 15 sites. Enrollment is expected to be completed in Q2 2021, and topline results are expected in the second half of 2021. The primary efficacy endpoint is change in maximum daily pain numerical rating score at Week 12, comparing lenabasum groups to placebo. The secondary endpoints include change from baseline in Active Lupus Musculoskeletal Disease Activity (BILAG-2004) and Change from baseline in Lupus Disease Activity (SELENA-SLEDAI Score). The National Institutes of Health is funding and managing this trial.
       
     Systemic Sclerosis – In 2020, lenabasum did not meet the primary endpoint in the RESOLVE-1 Phase 3 study of lenabasum in systemic sclerosis. Currently no systemic sclerosis patients are being treated with lenabasum. The Company is preparing the data from the RESOLVE-1 study for publication and will decide on the next steps in the development process pending the outcome of the DETERMINE study.
       
     Cystic Fibrosis – In 2020, lenabasum did not meet the primary endpoint in the Phase 2b study of lenabasum in cystic fibrosis. Corbus is preparing the cystic fibrosis study data for publication, but currently it does not have plans for additional clinical studies.

    Pipeline Updates:

     The cannabinoid receptor type 1 (CB1) inverse agonist program is in preclinical development for potential treatment of metabolic disorders such as obesity, diabetic nephropathy, diabetic retinopathy, and nonalcoholic steatohepatitis. Several compounds have demonstrated positive data in preclinical models of diet-induced obesity. These data were presented at the New York Academy of Sciences webinar in January 2020. Corbus is moving toward candidate selection and IND-enabling studies, and intends to initiate clinical studies in 2022.
       
     The cannabinoid receptor type 2 (CB2) agonist program is in preclinical development for potential treatment of cancer, investigating single agent activity and in combination with other cancer therapies such as checkpoint inhibitors. Several compounds have demonstrated positive data in preclinical models of solid tumors. These data were presented at the New York Academy of Sciences webinar in January 2020. The Company is moving toward candidate selection and IND-enabling studies, and intends to initiate clinical studies in 2022.
       
     Corbus is actively engaging with potential partners to expand its pipeline through acquisition of external assets. The Company is focusing on biology beyond the endocannabinoid system and new indications that will still leverage its expertise and capabilities within immunology.

    Financial Results for Fourth Quarter and Year-End December 31, 2020:

    Revenue from awards and licenses was $700,000 for the three months ended December 31, 2020, compared to $2.6 million in the comparable period in 2019. For the year ended December 31, 2020, revenue from awards and licenses was $3.9 million, compared to $36.1 million in the comparable period in 2019. Revenue for the year ended December 31, 2019 included a $27 million upfront payment received from Kaken Pharmaceutical Co., Ltd. for a license to commercialize and market lenabasum in Japan.

    Operating expenses were $21.5 million for the three months ended December 31, 2020, compared to $29.8 million in the comparable period in the prior year. For the year ended December 31, 2020, operating expenses were $126.7 million, compared to $113.2 million in the comparable period in the prior year. Increased expenses for the year were attributable to increased compensation costs, increased clinical trial costs and restructuring costs. Decreased operating expenses quarter over quarter were attributable to the completion of systemic sclerosis and cystic fibrosis in September and October of 2020, respectively. The Company expects expenses to decline in 2021 as a result of the completion in 2020 of clinical trials in systemic sclerosis and cystic fibrosis.

    The Company reported a net loss of approximately $8.6 million or a net loss per diluted share of $0.10, for the three months ended December 31, 2020, compared to a net loss of approximately $26.6 million, or a net loss per diluted share of $0.41, for the same period in 2019. For the year ended December 31, 2020, the Company reported a net loss of approximately $111.3 million, or a net loss per diluted share of $1.42, compared to a net loss of approximately $71.5 million, or a net loss per diluted share of $1.12, for the same period in 2019.

    Cash and cash equivalents were $85.4 million at December 31, 2020. During the fourth quarter of 2020 the Company raised $20.8 million in net proceeds from the Company's ATM facility, and in 2021 to date, the Company has raised $58.9 million in net proceeds from the Company's ATM facility. The $127 million of cash on hand at March 15, 2021 is expected to fund operations into the first quarter of 2024 based on the current planned expenditures.

    Conference Call and Webcast Information:

    Corbus management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Monday, March 15, 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 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

      December 31,  December 31, 
      2020  2019 
       (unaudited)     
    ASSETS        
    Current assets:        
    Cash and cash equivalents $85,433,441  $31,748,686 
    Restricted cash $350,000    
    Stock subscriptions receivable $960,033    
    Prepaid expenses and other current assets $3,712,861   3,724,932 
    Contract asset $1,618,296   2,681,065 
    Total current assets  92,074,631   38,154,683 
    Restricted cash  669,900    
    Property and equipment, net  4,067,837   5,083,865 
    Operating lease right of use asset  5,248,525   5,818,983 
    Other assets  234,038   84,968 
    Total assets $102,294,931  $49,142,499 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities:        
    Notes payable $710,158  $752,659 
    Accounts payable  7,381,183   11,091,363 
    Accrued expenses  22,005,432   22,447,939 
    Derivative liability  797,000    
    Operating lease liabilities, current  1,004,063   595,745 
    Total current liabilities  31,897,836   34,887,706 
    Long-term debt, net of debt discount  18,029,005    
    Operating lease liabilities, noncurrent  7,093,165   8,097,228 
    Total liabilities  57,020,006   42,984,934 
    Stockholders' equity        
    Preferred Stock $0.0001 par value:10,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and December 31, 2019      
    Common stock, $0.0001 par value; 150,000,000 shares authorized, 98,088,253 and 64,672,893 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively  9,885   6,467 
    Additional paid-in capital  349,358,378   198,975,056 
    Accumulated deficit  (304,093,338)  (192,823,958)
    Total stockholders' equity  45,274,925   6,157,565 
    Total liabilities and stockholders' equity $102,294,931  $49,142,499 



    Corbus Pharmaceuticals Holdings, Inc.

    Consolidated Statements of Operations


    (Unaudited)

      For the Three Months Ended  For the Twelve Months Ended 
      December 31,  December 31, 
      2020  2019  2020  2019 
    Revenue from awards and licenses $658,204  $2,573,519   3,937,230  $36,143,568 
    Operating expenses:                
    Research and development  16,110,287   23,487,675   98,267,213   89,604,790 
    General and administrative  5,360,231   6,276,155   28,480,250   23,643,357 
    Total operating expenses  21,470,518   29,763,830   126,747,463   113,248,147 
    Operating loss  (20,812,314)  (27,190,310)  (122,810,233)  (77,104,579)
    Other income (expense), net:                
    Other income (expense), net  13,266,206   472,500   13,270,211   4,581,838 
    Interest income (expense), net  (679,704)  151,477   (1,028,359)  1,227,643 
    Change in fair value of derivative liability  (40,000)  -   (251,000)  - 
    Foreign currency exchange loss, net  (346,058)  (14,428)  (449,999)  (158,620)
    Other income (expense), net  12,200,444   609,549   11,540,853   5,650,861 
    Net loss $(8,611,870) $(26,580,761)  (111,269,380) $(71,453,718)
    Net loss per share, basic and diluted $(0.10) $(0.41)  (1.42) $(1.12)
    Weighted average number of common shares outstanding, basic and diluted  87,207,293   64,660,017   78,133,289   63,899,184 

    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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