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Adherex Reports Recent Developments and Fiscal Year Ended December 31, 2011 Financial Results
March 27, 2012 17:30 ET
Adherex Reports Recent Developments and Fiscal Year Ended December 31, 2011 Financial Results
RESEARCH TRIANGLE PARK, NORTH CAROLINA--(Marketwire - March 27, 2012) - Adherex Technologies Inc. (TSX:AHX)(PINKSHEETS:ADHXF), a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today reported its financial results for the fiscal year ended December 31, 2011. All amounts are in U.S. dollars unless otherwise specified.
Recent Developments
- Eniluracil Phase II StudyUpdate - Enrollment in the Company's Phase II clinical trial for Metastatic Breast Cancer comparing the oral regiment of eniluracil + 5-Fluorouracil (5-FU) and leucovorin (Treatment Arm 1; n=80) versus Capecitabine (Xeloda®)(Treatment Arm 2; n=60 commenced on April 27, 2011. Patients who have disease progression in Arm 2 may crossover to take eniluracil plus 5-FU and leucovorin (Treatment Arm X). The eniluracil plus 5-FU and leucovorin regimen has been generally well-tolerated and shown activity in both Arm 1 and Arm X. To date, 104 of the 140 patients have enrolled in the trial and enrollment is expected to be completed during the third calendar quarter of 2012 and final data for progression-free survival to be available by the first quarter of 2013. The statistical comparison of Treatment Arms 1 and 2 will occur after the study has been completed.
- Sodium Thiosulfate (STS) Phase III Study Update - Enrollment continues in a Phase III trial with STS to prevent hearing loss in children receiving cisplatin-based chemotherapy in collaboration with the Children's Oncology Group. The goal is to evaluate in a multi-centered, randomized trial whether STS is an effective and safe means of preventing hearing loss in children receiving cisplatin-based chemotherapy for newly diagnosed germ cell, liver (hepatoblastoma), brain (medulloblastoma), nerve tissue (neuroblastoma) or bone (osteosarcoma) cancers. To date, 131 of the 135 patients have enrolled in the trial.
"Fiscal 2011 was an important year for Adherex. Thanks to the support of our shareholders, we successfully completed a $2.5 million Rights Offering that put us in a solid capital position to initiate and complete a Phase II trial for eniluracil + 5-FU. We are satisfied with our enrollment progress in both the eniluracil and STS trials during the year. We look forward to completing enrollment in both studies during 2012 and updating shareholders on the progress of these trials over the course of the next 12 months. " said Mr. Rosty Raykov, Chief Executive Officer of Adherex.
Financial Update
The Company reported a net loss from operations of $3.4 million excluding the $8.1 million non-cash gain on derivative warrants for the fiscal year ended December 31, 2011, compared to a net loss from operations of $4.6 million excluding the non-cash loss of $3.2 million in the same period in 2010. The decrease in the net loss from operations excluding the non-cash impact of derivative warrants is primarily due to a reduction in non-cash stock based compensation of $2.2 million that was offset by increased research and development expenses of $0.8 million in the comparable periods
Operating expenses, which exclude stock based compensation, totaled $3.1 million for the fiscal year ended December 31, 2011 compared to $2.1 million in the same period in 2010. The increase in operating expenses is primarily due to the higher clinical trial expenditures related to the eniluracil Phase II study. Research and development expenses totaled $1.5 million, as compared to $0.7 million in the same period in 2010.
Cash and cash equivalents totaled $5.3 million at December 31, 2011, compared to $5.9 million at December 31, 2010. The decreased cash balance is due to clinical trial and corporate expenses in the period offset by the approximate $2.5 million proceeds received by the Company from its March 2011 Rights Offering. At December 31, 2011, the Company had working capital totaling approximately $5.0 million compared to $5.5 million as of December 31, 2010.
The selected financial data presented below is derived from our audited consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete consolidated financial statements for the year ended December 31, 2011 and management's discussion and analysis of financial condition and results of operations will be available via [ www.sec.gov ] and [ www.sedar.com ].
FINANCIAL CHARTS FOLLOW
Adherex Technologies Inc. Selected Financial Data (U.S. dollars in thousands except per share amounts) |
Consolidated Balance Sheets: | December 31, 2011 | December 31, 2010 | |||||
Assets: | |||||||
Cash and cash equivalents | $ | 5,297 | $ | 5,947 | |||
Other current assets | 54 | 46 | |||||
Total assets | $ | 5,351 | $ | 5,993 | |||
Liabilities and stockholders' equity: | |||||||
Current liabilities | $ | 394 | $ | 467 | |||
Derivative warrant liability | 5,077 | 10,450 | |||||
Other long-term liabilities | - | - | |||||
Total stockholders' equity | (120 | ) | (4,924 | ) | |||
Total liabilities and stockholders' equity | $ | 5,351 | $ | 5,993 | |||
Consolidated Statements of Operations: | December 31, 2011 | December 31, 2010 | |||||
Revenue | $ | - | $ | - | |||
Operating expenses: | |||||||
Research and development | 1,494 | 708 | |||||
Impairment of Capital Assets | --- | --- | |||||
(Gain) on Deferred Lease Inducements | --- | --- | |||||
General and administrative | 1,944 | 3,896 | |||||
(Loss) from operations | (3,438 | ) | (4,604 | ) | |||
Other income (expense) | 9 | - | |||||
Gain/(Loss) on derivative warrants | 8,071 | (3,251 | ) | ||||
Interest income | 43 | 32 | |||||
Net income/(loss) and comprehensive (loss) | $ | 4,685 | $ | (7,823 | ) | ||
Basic net earnings/(loss) per common share | $ | 0.19 | $ | (0.49 | ) |
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2011. Adherex Technologies, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
For a more detailed discussion of related risk factors, please refer to our public filings available at [ www.sec.gov ] and [ www.sedar.com ].