Senesco Technologies Reports Fiscal Year 2012 Financial Results
<0> Senesco Technologies, Inc.Leslie J. Browne, Ph.D.President & CEO908-393-9393 </0>
Senesco Technologies, Inc. ("Senesco" or the "Company") (NYSE MKT: SNT) today announced financial results for the 12 months ended June 30, 2012 (“Fiscal 2012”).
* Represents 995 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 $0.26 per common share.
“We have achieved some very important milestones this past fiscal year and are extremely pleased with the results of the first cohort of the Phase 1b/2a clinical trial in the multiple myeloma study with SNS01-T,” stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco Technologies, Inc. Dr. Browne continued, “We have begun treating patients in the second cohort of the Phase 1b/2a clinical trial in multiple myeloma, and we are looking forward to reporting the results over the coming months as our lead candidate progresses through the Phase 1b/2a dose-escalation study. Based on the Phase 1b/2a study and our pre-clinical research results, the planning for our next clinical trial for Multiple Myeloma or Diffuse Large B-cell Lymphoma is underway. We hope to initiate a Phase 2 clinical trial in or around the second half of 2013. If the clinical trial program remains on track, the Company hopes to file a New Drug Application by the end of 2016 or during 2017.
Revenue for Fiscal 2012 was $200,000, which consisted of a milestone payment in connection with an agricultural license agreement. There was no revenue during Fiscal 2011.
Research and development expenses for Fiscal 2012 were $2,566,247, compared with $3,720,394 for Fiscal 2011, a 31% decrease. The decrease was primarily due to a decrease in costs incurred in connection with the Company’s development of SNS01-T for multiple myeloma. Specifically, during Fiscal 2011, the Company incurred significant costs related to its filing and follow-up of its investigational new drug application, pivotal toxicology study and other preclinical work that it did not incur during Fiscal 2012. This was partially offset by costs incurred related to the performance of the Phase 1b/2a clinical trial for multiple myeloma which were not incurred during Fiscal 2011.
General and administrative expenses were $2,724,144 for Fiscal 2012 compared with $2,610,222 for Fiscal 2011, a 4% increase. The increase was primarily due to an increase in stock-based compensation, payroll, professional fees and depreciation and amortization, which was partially offset by a decrease in investor relations and other general and administrative expenses.
The loss applicable to common shares for Fiscal 2012 was $6,691,860 or $0.08 per share compared with a loss applicable to common shares for Fiscal 2011 of $9,907,276 or $0.14 per share. This decrease in the loss applicable to common shares was primarily the result of a decrease in research and development costs, other non-operating expenses and the cost of dividends on preferred stock.
As of June 30, 2012, the Company had cash and cash equivalents in the amount of $2,001,325, compared to cash and cash equivalents of $3,609,954, as of June 30, 2011. Senesco has initiated a Phase 1b/2a clinical study with SNS01-T in multiple myeloma patients. Patients are currently being treated in the second cohort of the trial. The Company plans to fund research and development and commercialization activities by utilizing their current cash balance and investments, by achieving milestones set forth in current licensing agreements, through the execution of additional licensing agreements, and through the placement of equity and / or debt instruments. The Company believes that it has sufficient cash on hand to maintain operations through November 2012. However, the Company believes it has the ability to raise additional capital, utilize its unused line of credit and, if necessary, delay certain costs which will provide the Company with enough cash to fund its operations at least through March 31, 2013.
SNS01-T is a novel approach to cancer therapy that is designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell and diffuse large B-cell lymphomas. Senesco is the sponsor of the Phase 1b/2a study that is actively enrolling patients at Mayo Clinic in Rochester, MN, the University of Arkansas for Medical Sciences in Little Rock, and the Mary Babb Randolph Cancer Center in Morgantown, WV.
Multiple myeloma is an incurable cancer of plasma cells, a type of white blood cell derived from B-lymphocytes, normally responsible for the production of antibodies, in which abnormal cells accumulate in the bone marrow leading to bone lesions and interfering with the production of normal blood cells. Senesco was previously granted orphan drug status for SNS01-T, the Company’s lead drug candidate for treatment of multiple myeloma.
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma (NHL) accounting for up to 30 percent of newly diagnosed cases. DLBCL is a fast-growing B-cell lymphoma that can arise in lymph nodes or outside of the lymphatic system in several organs. It can progress rapidly if untreated. The prevalence of DLBCL in the United States is approximately 137,000 patients
Senesco, a leader in eIF5A technology, is running a clinical study in multiple myeloma with its lead therapeutic candidate SNS01-T, which targets B-cell cancers by selectively inducing apoptosis by modulating eukaryotic, translation, initiation Factor 5A (eIF5A), which is believed to be an important regulator of cell growth and cell death. Accelerating apoptosis may have applications in treating cancer, while delaying apoptosis may have applications in treating certain inflammatory and ischemic diseases. Senesco has already partnered with leading-edge companies engaged in agricultural biotechnology and biofuels development, and is entitled to earn research and development milestones and royalties if its gene-regulating platform technology is incorporated into its partners’ products.