Ym Biosciences Reports Fiscal Year End 2009 Operational and Financial Results
Press Release
Source: YM BioSciences Inc.
On Friday September 25, 2009, 7:00 am EDT
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SEVERE EDIT AND REARRANGEMENT
As at June 30, 2009 the Company had 58,216,309 common shares outstanding, of which 2,380,953 common shares held in escrow to be released contingent upon the completion of certain milestones.
Nimotuzumab is being advanced globally on multiple fronts supported by a network of cooperative relationships. In total, 32 Phase II and III clinical trials are currently ongoing, 11 of which are being conducted by YM's majority owned subsidiary, CIMYM BioSciences Inc., or its licensees
Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan,and YM's licensee in Korea, Kuhnil Pharmaceutical Co., are currently collaborating on a Phase II randomized, open-label trial they are conducting that is evaluating nimotuzumab plus irinotecan compared to
irinotecan alone in patients with advanced or recurrent gastric
cancer refractory to 5-FU-containing regimens which is designed to complete recruitment in calendar 2009. Daiichi has also launched a Phase II trial in first-line NSCLC bringing to three the number of NSCLC indications being investigated by our direct consortium.
- Randomized, Phase II, double-blind trials in brain metastases from non-small cell lung cancer (NSCLC) and in NSCLC patients ineligible for radical chemotherapy were initiated in Canada; recruitment commenced in March 2009 for NSCLC and in September for the brain metastases trial. A Phase II, second-line, single-arm trial in children with progressive diffuse intrinsic pontine glioma (DIPG) is ongoing at multiple sites in the US, Canada, and Israel.
- Oncoscience AG (OSAG), CIMYM's licensee for Europe, reports that it continues to recruit for a Phase III trial in adult glioma and a Phase II/III trial in pancreatic cancer.
- Innogene Kalbiotech PTE Ltd. (IGK), a subsidiary of Kalbe Farma, the largest public Southeast Asian pharmaceutical company and a CIMYM licensee, reported marketing approval in the Philippines and Indonesia, bringing to 21 the number of countries that are now reported as having approved the drug for sale in specific indications. In January 2009, the National Cancer Centre of Singapore announced that it was launching a worldwide Phase III, 710-patient trial of nimotuzumab in the adjuvant setting in head and neck cancer
in cooperation with IGK. This trial is in addition to the on-going investigator-initiated Phase II trial in locally advanced head and neck cancer and the initiation of a Phase II trial in cervical cancer.
- Subsequent to the end of the fiscal year, YM received a license from the US Department of the Treasury's Office of Foreign Assets Control(OFAC) to further develop its lead product, nimotuzumab, for patients in the United States. YM's first priority is discussion with the FDA on its two IND submissions to include US citizens in the randomized, double-blind Phase II trial of nimotuzumab in NSCLC patients
ineligible for radical chemotherapy and the parallel Phase II trial in patients with brain metastases from NSCLC, both of which YM initiated in Canada during the 2009 fiscal year. Development plans may also include extending one of the Phase III trials being conducted worldwide into the US, such as the multinational 710-patient Phase III trial of nimotuzumab in the adjuvant setting in head and neck cancer.
YM filed and received clearance for a "shelf" prospectus in Canada and the USA subsequent to the end of the fiscal year. A "shelf" facilitates financing by a company, reduces the time period during which a company must otherwise wait for a prospectus to be cleared, permits the sale to investors of shares without a "hold period" (thus significantly reducing the cost of capital) and permits the use of freely traded shares in the case of another acquisition by YM, again significantly reducing the prospective cost of capital. The "shelf" registration covers any financing during the forthcoming 25 months.
Total revenue for the fiscal year ended June 30, 2009 was $5.6 million compared with $7.4 million for fiscal 2008. Total revenue for the fourth quarter of fiscal 2009 was $0.8 million compared with $2.0 million for the fourth quarter of fiscal 2008. Revenue from out-licensing was $4.5 million for fiscal 2009 compared with $4.9 million for fiscal 2008. The decrease is mainly attributable to the 12 month extension of the revenue recognition period for the initial payment from Daiichi Pharmaceutical Co., Ltd, as a result of a revision to the estimated period of the collaboration. The majority of YM's out-licensing revenue comes from five out-licensing agreements with third party licensees. YM also began receiving royalty payments from a limited sales program in Europe in the fourth quarter of fiscal 2008.
The Company received an audit opinion for the fiscal year ended June 30, 2009 which included an explanatory paragraph referencing note 1 to the consolidated financial statements of the Company's fiscal 2009 annual report which discusses substantial doubt about the Company's ability to continue as a going concern as the Company has no net earnings, minimal revenue and negative operating cash flows.
YM had net cash of more than $41 million at June 30, 2009 which it believes is sufficient to continue its development activity well beyond the 2010 fiscal year.
The disclosure in note 1 is consistent with YM's disclosure in previous financial reports and is intended to alert readers to the risks inherent to the industry in which it operates, which include the reliance on the capital markets and uncertain partnership revenues.
As at June 30, 2009 the net cash consisted of cash and cash equivalents and short-term deposits totaling $42.1 million and payables and accrued liabilities totaling $0.9 million compared to $58.1 million and $2.0 million respectively at June 30, 2008.
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