During Wednesday’s current trade, Celsion Corp. (NASDAQ:CLSN)’s shares surged 19.30% to $3.17, showing an unusual surge in volume of 3,779,738 shares as contrast to its average volume of 197,230.
Recently, Celsion Corp, declared positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer. The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data accessible to date, 67% of patients practiced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients, notably 5 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). The Company remains on track to complete enrollment in the study in the third quarter of 2015.
These data are compriseent with the formerly stated Phase 1 data for ThermoDox® plus hyperthermia in RCW breast cancer, counting combined clinical data from the Company’s Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox®. The two similarly designed studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. There were 29 patients treated in the two trials, representing 11 patients in the DIGNITY study and 18 patients in the Duke study. Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was stated in 14 of the 23 evaluable patients, with 5 complete responses and 9 partial responses.
The Euro-DIGNITY trial will evaluate ThermoDox® plus hyperthermia in RCW breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company. In addition, Celsion has a license and distribution contract with myTomorrows to implement an Early Access Program (EAP) for ThermoDox® in all countries of the European Union territory plus Switzerland for the treatment of patients with RCW breast cancer. The Company anticipates to have ThermoDox® accessible for sales at commercial prices to physicians who are treating patients with limited therapeutic options in the second quarter of 2015. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place.
Celsion Corporation, an oncology drug development company, focuses on the development and commercialization of chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology.
During an early morning trade, Biodel Inc. (NASDAQ:BIOD)’s shares declined -2.91% to $1.00, showing an unusual surge in volume of 1,695,106 shares as contrast to its average volume of 202,000.
Recently, Biodel declared that it has priced a public offering of 32,608,696 shares of its ordinary stock at a price of $0.92 per share. The offering is predictable to close on April 20, 2015, subject to customary closing conditions. In addition, Biodel has granted the underwriters a 30-day option to purchase up to 4,891,304 additional shares of ordinary stock to cover over-allotments, if any.
William Blair and Ladenburg Thalmann are acting as joint book-running managers for the offering. Roth Capital Partners is acting as co-manager.
The gross proceeds to Biodel from this offering are predictable to be about $30,000,000 before deducting underwriting discounts and commissions and other offering expenses payable by Biodel. All of the shares in the offering are being sold by Biodel. Biodel intends to use the net proceeds from the offering for operating costs, capital expenditures and for general corporate purposes, counting working capital.
Biodel Inc., a specialty biopharmaceutical company, focuses on the development and commercialization of treatments for diabetes in the United States. Its lead product candidate is a glucagon emergency administration (GEM) device that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose.
Smart & Final Stores, Inc. (NYSE:SFS), during its Wednesday’s current trading session lost -1.74%, to $18.66, showing an unusual surge in volume of 2,130,361 shares as contrast to its average volume of 207,436.
Yesterday, a food retailer declared the pricing of an underwritten public offering of 10.0 million shares of its ordinary stock by certain stockholders of the Company, counting associates of Ares Administration, L.P., at a public offering price of $18.50 per share.
Ares is selling about 9.98 million shares of ordinary stock in the offering. In addition, the selling stockholders have granted to the underwriters the option to purchase up to an additional 1.5 million shares of ordinary stock. Smart & Final Stores will not issue any shares in connection with the offering and will not receive any proceeds from the sale of the shares by the selling stockholders.
The offering is predictable to close on April 20, 2015, subject to customary closing conditions.
Smart & Final Stores, Inc. operates as a food retailer in the United States. The company operates through two segments, Smart & Final and Cash & Carry. It operates non-membership warehouse-style grocery stores under the Smart & Final banner in California, Arizona, and Nevada, in addition to under the Cash & Carry banner in Washington, Oregon, California, Idaho, and Nevada.
Finally, Monroe Capital Corporation (NASDAQ:MRCC), lost -3.34% Wednesday, showing an unusual surge in volume of 411,470 shares as contrast to its average volume of 53,164.
Recently, Monroe Capital declared the pricing of an underwritten public offering of 2,450,000 shares of its ordinary stock at a public offering price of $14.85 per share, raising about $36.4 million in gross proceeds. The Company has granted the underwriters a 30-day option to purchase up to an additional 367,500 shares of its ordinary stock to cover over-allotments, if any.
The Company intends to use the net proceeds from the offering to repay indebtedness, to invest in portfolio companies in accordance with its investment objectives and for other general corporate purposes. The Company will also pay operating expenses, counting administration and administrative fees, and may pay other expenses from the net proceeds of this offering.
Monroe Capital Corporation is a publicly-traded specialty finance company that principally invests in senior, unitranche and junior secured debt and, to a lesser extent, unsecured subordinated debt and equity investments in middle-market companies.
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