YM BioSciences Inc. has reported operational and financial results for the third quarter of fiscal 2011, ended March 31, 2011.
"We continue to advance our JAK1/JAK2 inhibitor CYT387 in the clinic and look forward to reporting interim data from our Phase I/II trial at ASCO in June, with mature data from the full trial anticipated by the end of the calendar year," said Dr. Nick Glover, President and CEO of YM BioSciences.
Glover continued, "Investigators recently reported that CYT387 continues to improve anemia in a substantial portion of patients in the trial. If this effect, combined with CYT387's demonstrated ability to rapidly shrink spleens and improve constitutional symptoms, continues to prove robust and durable, our drug could become an important clinical option in the emerging JAK inhibitor class."
∙ CYT387 is currently being studied in a Phase I/II trial for the treatment of patients with myelofibrosis. Enrollment in the trial has exceeded the initial target of 140 patients, is expected to close in calendar Q2 2011 and include approximately 155 patients.
∙ During the quarter an abstract was submitted for publication at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) describing updated interim data from the first 60 patients in the Phase I/II trial. The Company anticipates that these data will be further updated and reported on at the ASCO meeting in early June 2011 during an oral poster session. YM also anticipates that initial evaluable data from a subset of the full group of patients enrolled in the trial also will be reported at ASCO and that more mature data from the full trial will be reported by the end of calendar 2011.
∙ Subsequent to the end of the quarter, updated interim anemia response data were reported for the first 60 patients enrolled in the Phase I/II trial at the First Annual Florence Meeting on Myeloproliferative Neoplasms held in Florence, Italy. The overall anemia response rate was reported as 58% in 33 transfusion-dependent patients. Anemia response required a transfusion-free period of ≥12 weeks while on protocol drug therapy, with a minimum hemoglobin level of 8 g/dL. The median duration of transfusion independence was reported to be six months (range 4-15 months). Only two (11%) of the 19 patients who achieved transfusion-independency were reported to require single episodes of PRBC transfusions.
∙ YM continues toward completion of preclinical, manufacturing and regulatory activities required to enable CYT387 to commence a pivotal trial in late calendar H1 2012. The Company will also announce plans in H2 2011 for clinical trials evaluating CYT387 in other indications where the drug potentially could be effective.
∙ Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan, presented data during the quarter from a randomized trial with nimotuzumab in second line gastric cancer at the ASCO Gastrointestinal Cancers Symposium. Nimotuzumab demonstrated an improvement in Progression Free Survival in a subset of patients whose tumors were EGFR-positive. Daiichi Sankyo also has advised that data from its Phase II trial for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been submitted for presentation at a scientific conference being held in the second half of calendar 2011.
∙ YM's two randomized, Phase II, double-blind trials of nimotuzumab (for brain metastasis from NSCLC and for palliative treatment of NSCLC) are lagging recruitment targets and consequently the continuation of these studies is under review as the Company focuses support on the more advanced programs involving its partners. YM's Phase II, second-line, single-arm study in children with progressive diffuse intrinsic pontine glioma (DIPG) has concluded recruitment at multiple sites in the US, Canada, and Israel and YM anticipates reporting results in calendar Q3 2011.
∙ Oncoscience AG (OSAG), CIMYM's licensee for Europe, has advised that updated data from its Phase III trial in adult glioma patients and its physician led trial in children with DIPG will be reported at the 2011 ASCO Annual Meeting in June. OSAG continues to recruit patients into a Phase IIb/III trial for pancreatic cancer patients.
∙ CYT997 is a small molecule therapeutic with dual mechanisms of vascular disruption and cytotoxicity, capable of being developed in both intravenous and oral dose formulations. The Phase I/II trial of CYT997 given intravenously with platinum chemotherapy in glioma patients closed enrollment during the quarter and preliminary data from the trial are expected in calendar H2 2011.
Financial Results (CDN dollars)
Revenue currently primarily consists of revenue from out-licensing contracts and interest income. Total revenue for the third quarter of fiscal 2011, ended March 31, 2011, was $0.4 million compared to $0.7 million for the third quarter of fiscal 2010, ended March 31, 2010. Total revenue for the first nine months of fiscal 2011, ended March 31, 2011, was $1.1 million compared to $2.2 million for the first nine months of fiscal 2010, ended March 31, 2010.
Licensing and product development expenses were $5.2 million for the third quarter of fiscal 2011 compared to $4.5 million for the third quarter of fiscal 2010. Licensing and product development expenses were $15.7 million for the first nine months of fiscal 2011 compared to $9.3 million for the first nine months of fiscal 2010.
The increases mainly were due to increased development expenses for CYT387 offset by decreased expenses for nimotuzumab, as well as an increase in amortization expense from CYT387, CYT997, and the small molecule drug library, all acquired in January 2010, and increases in salaries, travel and office expenses as a result of restructuring and the addition of the Australian office.
General and administrative expenses were $1.9 million for the third quarter of fiscal 2011 compared with $1.6 million for the third quarter of fiscal 2010. General and administrative expenses were $7.4 million for the first nine months of fiscal 2011 compared with $5.1 million for the first nine months of fiscal 2010.
The increases were due mainly to higher stock-based compensation expense, restructuring costs, bonuses awarded and increased Board of Director fees and travel expenses. These increases were partially offset by one-time costs associated with the acquisition of Cytopia incurred in fiscal 2010.
Net loss for the third quarter of fiscal 2011 was $7.2 million ($0.06 per share) compared to $5.5 million ($0.09 per share) for the same period last year. Net loss for the first nine months of fiscal 2011 was $23.2 million ($0.25 per share) compared to $12.4 million ($0.21 per share) for the same period last year.
As previously announced, on April 23, 2010, the Company entered into a Sales Agreement with Cantor Fitzgerald & Co. (CF&Co), under which the Company may, at its discretion, from time to time, sell up to a maximum of 7,750,000 of its common shares through an "at-the-market" equity offering program known as a Controlled Equity Offering. CF&Co will act as sales agent for any sales made under the Controlled Equity Offering.
The common shares may be sold at market prices prevailing at the time of a sale (if any) of the common shares or at prices negotiated with CF&Co. The term of the Controlled Equity Offering extends until October 16, 2011 and the Sales Agreement does not prevent the Company from conducting additional financings. During the quarter, the Company sold 500,000 shares through the Controlled Equity Offering program at a weighted average price of US$2.7169 per common share for gross proceeds of $1,321,932 (US$1,358,460) resulting in net cash proceeds of $1,165,392.
As at March 31, 2011, the Company had cash and short-term deposits totaling $73.5 million and accounts payables and accrued liabilities totaling $3.7 million compared to $45.6 million and $2.8 million respectively, at June 30, 2010. Management believes that the cash and short-term deposits at March 31, 2011 are sufficient to support the Company's activities for at least the next 18 months.
Subsequent to the end of the quarter, the Company sold 5,225,000 shares through the Controlled Equity Offering program at a weighted average price of US$2.50 per common share for gross proceeds of $12,456,288 (US$13,072,848) resulting in net cash proceeds of $12,072,836.
As at March 31, 2011 the Company had 111,094,312 common shares and 7,429,137 warrants outstanding. As at April 30, the Company had 116,467,644 shares outstanding.