MISSISSAUGA, ON, Nov. 12 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported operational and financial results for the first quarter of fiscal 2008, ended September 30, 2007.
“We launched into our 2008 fiscal year by further increasing the level of clinical activity for our lead drug, nimotuzumab,” said David Allan, Chairman and CEO of YM BioSciences. “In July 2007, we initiated patient enrollment for our colorectal cancer trial - the first trial using nimotuzumab with chemotherapy in a bulky tumor. Data from this trial could provide important evidence supporting the observations to date that nimotuzumab can deliver efficacy without the debilitating side effects common to other EGFR-targeting drugs. In August 2007, YM-USA received clearance from the FDA to initiate a 44-patient clinical trial in children with diffuse, intrinsic pontine glioma (DIPG), an inoperable progressive brain cancer.”
“More recently our licensee in Europe, Oncoscience AG, recruited its first patients into a randomized Phase III trial in first line adult glioblastoma grade IV and a Phase IIb/IIIa randomized, placebo controlled trial in patients with advanced pancreatic cancer for which YM has received clearance to extend into Canada. Moreover, Daiichi-Sankyo, our licensee in Japan, has advised us that it has completed its preliminary trials with nimotuzumab, permitting it to advance into more advanced trials in 2008,” added Mr. Allan. “We also continued to progress the development of AeroLEF(TM) and the FDA have scheduled an end-of-Phase II meeting to discuss the Phase III trial design. The first US trial for AeroLEF(TM) has been cleared to proceed by the FDA and is pending clearance with the relevant Investigator Review Boards.”
Nimotuzumab:
Nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), is currently in varying stages of development in a number of trials, including colorectal cancer, adult and pediatric glioma, non-small-cell lung cancer and pancreatic cancer. During the first quarter of fiscal 2008:
AeroLEF(TM) is a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. AeroLEF(TM) uniquely permits patients to identify and select the appropriate dose in real-time for each pain episode to achieve both rapid onset and extended duration of analgesia. During the first quarter of fiscal 2008:
Total revenue for the first quarter of fiscal 2008, ended September 30, 2007 was $1.8 million compared with $1.8 million for the first quarter of fiscal 2007, ended September 30, 2006. Revenue from out-licensing was $1.1 million for first quarter of fiscal 2008 compared with $0.9 million for the first quarter of fiscal 2007. Interest income for the first quarter of fiscal 2008 was $0.7 million compared with $0.9 million for the first quarter of fiscal 2007.
Total operating expenditures for the first quarter of fiscal 2008 were $5.6 million compared to $9.7 million for the first quarter of fiscal 2007. General and administrative expenses were $2.0 million for the first quarter of fiscal 2008 compared with $1.9 million for the first quarter of fiscal 2007. Licensing and product development expenses decreased to $3.5 million for the first quarter of fiscal 2008 compared to $7.9 million for the first quarter of fiscal 2007. The change is mainly the result of reduced development activity for tesmilifene, for which a Phase III trial was terminated in January 2007, and reduced clinical development costs for nimotuzumab and AeroLEF(TM), for both of which certain trials have finished and others are just starting up.
Net loss for the first quarter of fiscal 2008 was $3.6 million ($0.06 per share) compared to $9.7 million ($0.17 per share) for the same period last year.
As at September 30, 2007 the Company had cash and cash equivalents and short-term deposits totaling $71.1 million and payables and accrued liabilities totaling $2.2 million compared to $75.6 million and $3.3 million respectively at June 30, 2007.
As at September 30, 2007 the Company had 58,216,309 common shares outstanding, of which 2,380,953 common shares are held in escrow for contingent additional payment related to the acquisition of Delex Therapeutics Inc., 5,799,765 warrants, and 6,155,662 options.
AGM Announcement
YM BioSciences’ Annual Meeting of Shareholders will be held on November 28th, 2007 at 4:00 p.m. at the Gallery of the TSX Broadcast & Conference Centre, The Exchange Tower, 130 King Street West, Toronto, Ontario.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEF(TM), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(TM) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Thomas Fechtner, the Trout Group LLC, Tel. (646) 378-2931, Email:
tfechtner@troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Email: jsmith@equicomgroup.com; Nominated Adviser,
Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
