Key Developments: Coronado Biosciences Inc (CNDO.W)
9.55USD
24 May 2013
$-0.09 (-0.93%)
$9.64
$9.55
$9.55
$9.40
700
1,056
$12.60
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Latest Key Developments (Source: Significant Developments)
Coronado Biosciences Inc Announces Resignation Of President-Form 8-K
Coronado Biosciences Inc reported in its Form 8-K that on April 22, 2013, President, Dr. Bobby W. Sandage, Jr., resigned from his position as President and as a Director of the Company, effective immediately. Full Article
Coronado Biosciences Inc Announces Initiation Of Investigator-Initiated Study Evaluating TSO In Psoriasis
Coronado Biosciences Inc announced the initiation of an Investigator-Initiated Study (IIS) evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of psoriasis. The first site initiated in the multicenter study is the Icahn School of Medicine at Mount Sinai (ISMMS). Dr. Mark G. Lebwohl, Sol and Clara Kest Professor and Chairman of the Department of Dermatology, is the Principal Investigator of the trial at ISMMS. This trial is an open-label study designed to enroll 20 patients with moderate to severe plaque psoriasis. ISMMS is the first of three sites which the company anticipates being involved in this study. Participants will receive eight doses of either TSO 2500 or TSO 7500 orally every other week over a 16-week treatment period. The trial will evaluate the effect of TSO on clinical response of psoriasis. The primary endpoint will be the average improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 16. The goal of the pilot study is to test for early safety and efficacy of TSO at two different doses. Psoriasis (psoriasis vulgaris) is a chronic inflammatory skin disease characterized by red, scaly, raised plaques. The disease process is driven by T-cell infiltration and associated elevation in cytokine levels leading to increased cell division and aberrant differentiation, resulting in the psoriatic phenotype. Full Article
Coronado Biosciences Inc Announces Key Addition To Management Team
Coronado Biosciences Inc announced the appointment of Harlan F. Weisman, M.D., a director for the Company since August 2012, as its new Chairman and Chief Executive Officer (CEO). Bobby W. Sandage, Jr., will continue in his role as President and a member of the Board of Directors. In addition, Glenn L. Cooper, M.D., will step down as Executive Chairman of the board of the Company, although Dr. Cooper will continue to support the company in a consulting role. Full Article
Coronado Biosciences Inc Signs Clinical Trial Agreement With The National Institute Of Allergy And Infectious Diseases
Coronado Biosciences Inc announced the signing of a Clinical Trial Agreement between the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and Coronado Biosciences to evaluate TSO ( Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC) in a phase 2 clinical trial. This multi-center study will be conducted by the NIAID-funded Autoimmunity Centers of Excellence (ACE). The phase 2 trial is a randomized, double-blind, placebo-controlled clinical study designed to examine the safety and efficacy of TSO treatment in active left-sided ulcerative colitis and effects on mucosal immune state and microbiota. The trial will randomize 120 people in a 1:1 ratio to receive either TSO 7500 or placebo. Full Article
Coronado Biosciences Inc Initiates Phase 1/2 Trial Of CNDO-109 Activated Allogeneic Natural Killer Cells In Acute Myeloid Leukemia
Coronado Biosciences Inc announced the initiation of a phase 1/2 dose escalation trial of allogeneic natural killer (NK) cells activated by the Company's CNDO-109 in patients in first complete remission (CR1) from acute myeloid leukemia (AML), and who are deemed high-risk for relapse. The phase 1/2 trial is a multi-center, open-label, single-dose, dose-escalating clinical study designed to examine the safety of CNDO-109 activated allogeneic NK cells, as well as the relapse-free survival and overall survival in adult patients with AML. Up to 36 patients who are in CR1 from AML at the time of enrollment, and who are at high-risk for relapse, will be infused with a preparatory regimen of cyclophosphamide and fludarabine followed by a single dose of allogeneic NK cells activated by CNDO-109. Full Article
Coronado Biosciences Inc Secures $15 Million Loan Facility From Hercules Technology Growth Capital
Coronado Biosciences Inc announced that it has entered into a $15 million secured loan facility, fully funded at closing, with Hercules Technology Growth Capital, Inc. company into customized debt financing for companies in life sciences and technology-related markets. The loan is repayable in installments over forty-two months, including an initial interest-only period of twelve months after closing. Subsequently, the principal, together with interest, will be repaid over the following 30 months. Pursuant to the loan agreement, Coronado issued Hercules a warrant to purchase 73,009 shares of Coronado common stock at an exercise price of $5.65 per share. Full Article
Coronado Biosciences Inc Announces Closing Of $28.8 Million Public Offering
Coronado Biosciences Inc announced that it closed its previously announced underwritten public offering of 5,750,000 shares of its common stock at a price to the public of $5.00 per share for gross proceeds to Coronado of $28.8 million. The shares include 750,000 shares of common stock sold pursuant to the over-allotment option granted by Coronado to the underwriters, which option was exercised in full. Coronado expects net proceeds of the offering will be approximately $26.5 million, after deducting underwriting commissions and other offering expenses. Oppenheimer & Co. Inc. and Roth Capital Partners acted as joint book-running managers for the offering. National Securities Corporation acted as an underwriter for the offering. The Company expects to use the net proceeds from the sale of the shares primarily to fund clinical trials for the Company's product candidates, to fund the Company's research and development activities, for working capital and general corporate purposes. Full Article
Coronado Biosciences Inc Announces Pricing of Public Offering of Common Stock
Coronado Biosciences Inc announced the pricing of its underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $5.00 per share for gross proceeds to Coronado of $25.0 million. Coronado expects to receive approximately $23.0 million in net proceeds from the offering, after deducting underwriting discount and estimated offering expenses. The Company also has granted the underwriters a 30-day option to purchase up to an aggregate of 750,000 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on June 27, 2012. Oppenheimer & Co. Inc. and Roth Capital Partners are acting as joint book-running managers for the offering. National Securities Corporation is acting as an underwriter for the offering. The Company expects to use the net proceeds from the sale of the shares primarily to fund clinical trials for the Company's product candidates, to fund the Company's research and development activities, for working capital and general corporate purposes. Full Article
Coronado Biosciences Inc Receives Orphan-Drug Designation From FDA For CNDO-109-Activated Allogeneic Natural Killer Cells For Treatment Of AML
Coronado Biosciences Inc announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to CNDO-109-Activated Allogeneic Natural Killer Cells (CNDO-109) for the treatment of acute myeloid leukemia (AML). CNDO-109 is a biologic that activates the immune system's natural killer cells to seek and destroy cancer cells. Preclinical studies of CNDO-109 have demonstrated activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer and, based on data obtained from a Phase 1 investigator-sponsored clinical trial in patients with AML, the Company believes early efficacy was observed. Coronado currently plans to initiate a Phase 1/2 dose escalation trial in AML patients in the second half of 2012. Full Article
Coronado Biosciences Inc Signs Collaboration Agreement With Dr. Falk Pharma And OvaMed For The Development Of TSO For Crohn's Disease
Coronado Biosciences Inc announced that the Company signed a Collaboration Agreement with Dr. Falk Pharma GmbH (Falk) and OvaMed GmbH (OvaMed) for the development of TSO (Trichuris suis ova or CNDO-201) for Crohn's disease. On December 22, 2011, Coronado announced the execution of a binding Terms of Agreement with respect to this collaboration. Under the Collaboration Agreement, Falk granted Coronado exclusive rights and licenses under certain Falk patent rights, pre-clinical data and clinical data from Falk's clinical trials of TSO in Crohn's disease, including an ongoing Phase 2 clinical trial, for use in North America, South America and Japan. Coronado granted Falk exclusive rights and licenses to data from Coronado's clinical trials of TSO in Crohn's disease for use in Europe. Under the agreement, Coronado agreed to pay Falk a total of EUR5 million after receipt of certain pre-clinical and clinical data, all of which is estimated to be paid within 12 months, and a royalty of 1% of net sales of TSO. Coronado has licensed TSO, a orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines, from OvaMed, the manufacturer of the product, in North America, South America and Japan. Falk has licensed TSO from OvaMed for gastroenterology indications in Europe. Full Article
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