- The Company completed the second cohort of patients in its Phase 1b/2a clinical trial for the treatment of multiple myeloma, diffuse large B-cell lymphoma and mantle cell lymphoma with SNS01-T, the Company’s lead drug candidate. In cohort 2, two multiple myeloma patients and one diffuse large B-cell lymphoma patient completed the required number of doses to be evaluable from the total of 4 patients enrolled. As with the previous dose level, there were no drug-related serious adverse events or dose-limiting toxicities in the evaluable patients or in the one patient who received only 5 infusions before being withdrawn. Over cohorts 1 and 2 at the two lowest dose levels, stabilization of serum monoclonal protein levels had been observed in three of the five evaluable multiple myeloma patients, and, in three of nine patients overall.
- In the first quarter of fiscal 2014, the Company began dosing patients in the third cohort at a four-fold increase in the dose level from 0.05 mg/kg to 0.2 mg/kg in its Phase 1b/2a clinical trial for the treatment of multiple myeloma, diffuse large B-cell lymphoma and mantle cell lymphoma. At this does level, the Company has seen efficacy in the preclinical cancer models in mice.
- A poster entitled “Combination Therapy with Novel Nanoparticle, SNS01-T, and Bortezomib Results in Synergistic Cytotoxicity in Vitro and in Vivo in Multiple Myeloma” was presented at the 16 th annual meeting of the American Society of Gene & Cell Therapy.
- The Company completed an equity offering of $1,255,000 in gross proceeds in May 2013.
- The Company completed a warrant exchange program in June 2013 whereby outstanding warrants to purchase 30,000,000 shares of common stock were exchanged for shares of common stock and 165 shares of Series A Convertible Preferred Stock were converted into an aggregate of 35,250,000 shares of common stock. Subsequent to the warrant exchange and as of August 31, 2013, the capitalization table of the Company consisted of the following:
|Common Stock outstanding||231,901,368|
|Preferred Stock *||22,166,667|
|*||Represents 665 shares of Series A 10% Convertible Preferred Stock, with a stated value of $1,000 per share. Such 10% Convertible Preferred Stock is currently convertible into common stock at a conversion rate of $0.03 per common share.|