YM Biosciences reports 2006 year end operational and financial results
Friday September 22, 7:00 am ET
MISSISSAUGA, ON, Sept. 22 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), a company engaged in the acquisition, development and commercialization of oncology and acute care products, today reported operational and financial results for the fourth quarter and the 2006 fiscal year, ended June 30, 2006.
"In fiscal 2006, we made exceptional progress in strengthening YM's fundamentals. We move into fiscal 2007 with significant cash reserves and an advanced product pipeline that has the prospect of yielding registration data for both of our lead cancer drugs within the next 12-15 months," said David Allan, Chairman and CEO of YM BioSciences. "The pivotal trial for tesmilifene, our lead clinical candidate, has been the subject of two interim analyses of safety and survival data which indicated the drug continues to be safe and the trial continues to have the prospect of meeting its survival endpoint. A third interim analysis is anticipated in the coming months, a fourth possibly in Q1 2007 and mature data during calendar 2007."
"For Nimotuzumab, data from numerous trials continue to demonstrate the unique and competitive safety profile of this drug including an absence of the side effects typically seen with other products in this drug class, notably rash, severe diarrhea, conjunctivitis and hypomagnesemia. As this drug progresses through a Phase III trial in pediatric glioma in Europe, these properties could position nimotuzumab to become the EGFr-targeting drug best suited for chronic use and we are encouraged by its having been approved, for commercial use, by regulatory authorities in a number of countries," added Mr. Allan.
Highlights of Fiscal 2006 (July 1, 2005 - June 30, 2006):
Tesmilifene
- Enrolment of 723 patients in the pivotal Phase III trial of
tesmilifene in metastatic and recurrent breast cancer was completed.
- FDA Fast Track designation for tesmilifene in advanced breast cancer
was received.
- A hypothesis of tesmilifene's mode of action authored by Dr. Mark
Vincent in Medical Hypotheses, Vol. 66 # 4, was published.
- Positive results of a Phase II trial in hormone refractory prostate
cancer were published in the November 2005 issue of the Journal of
Urology.
- Collaborative agreement was signed with Sanofi-Aventis to investigate
the effect of combining tesmilifene and Taxotere® (docetaxel) for
treatment of women with rapidly progressing metastatic breast cancer.
Nimotuzumab
- YM's partner, Oncoscience AG, commenced patient treatment in a
Phase III trial in Germany with nimotuzumab. The trial is expected to
complete patient recruitment in the first half of calendar 2007. The
drug is also undergoing a Phase II monotherapy trial in Europe in
patients with advanced metastatic pancreatic cancer.
- Oncoscience AG presented updated positive data from a Phase II
monotherapy trial of nimotuzumab in children with resistant or
relapsed brain cancers at the International Society of Paediatric
Oncology conference on September 18, 2006.
- A multi-center Phase I/II trial comparing the effects of the
combination of nimotuzumab with radiation against radiation alone in
patients with non-small-cell lung cancer (NSCLC) unfit for
chemotherapy was initiated. Recruitment for the trial should be
completed in late calendar 2007 or early 2008. The trial is expected
to be expanded into South Korea through YM partner Kuhnil
Pharmaceutical Company of Seoul, Korea.
AeroLEF(TM)
- A randomized Phase IIb trial with AeroLEF(TM) for the treatment of
moderate to severe post-operative acute pain was initiated in 2006
and a preliminary report is expected in calendar Q4, 2006. YM intends
to continue development with the goal of initiating a Phase III trial
in the U.S. subject to positive Phase II data.
Other product highlights
- Clinical trial results for its anti-GnRH prostate cancer vaccine,
Norelin(TM), in hormone sensitive prostate cancer (HSPC) were
presented at the "Cancer Vaccines/Adjuvants/Delivery for the Next
Decade" conference in Lisbon, Portugal September 5-7, 2005.
- An exclusive worldwide license agreement with the University of
Saskatchewan for a portfolio of small molecule compounds that appear
to be highly potent enhancers of the activities of existing
chemotherapeutic treatments was completed.
Corporate highlights
- Licensed South Korean development and marketing rights for
nimotuzumab to Kuhnil Pharmaceuticals Ltd. of Seoul, South Korea.
- Licensed Southeast Asian and some African development and marketing
rights for nimotuzumab to Innogene Kalbiotech, a subsidiary of PT.
Kalbe Farma Tbk. of Jakarta, Indonesia.
- Licensed nimotuzumab, subsequent to the year-end, to Daiichi
Pharmaceutical Co., Ltd., a subsidiary of Daiichi Sankyo Company,
Limited, for the Japanese territory and received an up-front payment
of US$14.5 million and potentially significant milestone payments at
certain stages of development for each of a number of indications as
well as payments based on supply of nimotuzumab and sales performance
in the territory.
- Acquired Eximias Pharmaceutical Corporation, obtaining an experienced
senior management team and approximately US $29.5 million in cash.
- Raised US $40.1 million through a "registered direct" offering of
common shares.
- The Company's first "R&D Day" was held in New York for analysts and
portfolio managers.
Financial Results (all figures in Canadian dollars)
Total revenue for the fiscal year ended June 30, 2006 was $2.5 million compared to $1.5 million for the fiscal year ended June 30, 2005. Total revenue for the fourth quarter ended June 30, 2006 was $1.1 million compared to $0.3 million for the same quarter last year. The increases were primarily due to increased interest income resulting from the Company's significantly larger short-term deposits compared with the previous year.
Total operating expenditures for the fiscal year ended June 30, 2006 were $28.1 million compared to $17.3 million for the fiscal year ended June 30, 2005. Total operating expenditures for the fourth quarter ended June 30, 2006 were $9.3 million compared to $6.9 million for the same quarter in 2005.
General and Administrative expenses for the fiscal year ended June 30, 2006 were $8.0 million compared to $6.3 million for the fiscal year ended June 30, 2005. General and Administrative expenses for the quarter ended June 30, 2006 were $3.4 million compared to $2.3 million for the same quarter in the prior year. General and Administrative expenses increased in 2006 over 2005 due principally to higher legal costs, stock-exchange and investor-related costs and stock-based compensation expenses.
Licensing and Product Development expenses for the fiscal year ended June 30, 2006 were $20.2 million compared to $11.0 million for the fiscal year ended June 30, 2005. Licensing and Product Development expenses for the fourth quarter ended June 30, 2006 were $5.9 million compared to $4.5 million for the same quarter in 2005. Licensing and Product Development expenses increased from 2005 due to the progression of the tesmilifene Phase III clinical trial, development of the AeroLEF(TM) technology, increased out-licensing activity and the inclusion of Eximias results for two months.
Net loss for the fiscal year and fourth quarter ended June 30, 2006 was $25.8 million ($0.59 per share) and $8.6 million ($0.16 per share) compared to $15.9 million ($0.47 per share) and $6.5 million ($0.18 per share) respectively for the same periods last year.
On February 16, 2006, the Company raised gross proceeds of US$40.1 million through a "registered direct" offering of common shares.
Subsequent to the end of the fiscal year, on July 25, 2006 the Company entered into a License, Development, Manufacturing and Supply Agreement for nimotuzumab. Under the terms of the agreement, the Company has received a license fee of US$14,500,000. The agreement also entitles the Company to receive milestone payments on the occurrence of events specified in the terms of the contract and further payments based on the commercial sale of the developed product. The license fee will be recognized over the term of the related development collaboration.
As at June 30, 2006 the Company had 55,781,523 common shares outstanding, 2,380,953 common shares held in escrow for contingent additional payment related to the acquisition of Delex Therapeutics Inc., 9,022,777 warrants, and 4,779,789 options.
AGM Announcement
YM BioSciences' Annual and Special Meeting of Shareholders will be held on November 28th, 2006 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 engaged in the acquisition, development and commercialization of oncology and acute care products.
Tesmilifene is a small molecule MDR-targeting agent that is being tested in combination with various standard chemotherapy regimens for the treatment of cancer. In addition to the Phase III DEC trial combining tesmilifene with an anthracycline, a collaborative trial with Sanofi-Aventis is currently ongoing combining tesmilifene with Taxotere® (docetaxel) a taxane drug. A trial combining tesmilifene with epirubicin, cyclophosphamide, and 5-FU is anticipated for the treatment of gastric cancer and additional trials are in planning.
In addition, YM BioSciences is developing nimotuzumab, AeroLEF(TM) and Norelin.
Nimotuzumab is an anti-EGFR humanized antibody that was recently partnered in Japan with Daiichi Pharmaceutical Co., Ltd., a subsidiary of Daiichi Sankyo Company, Limited Nimotuzumab was approved in India in July 2006 for the treatment of head & neck cancer, is currently in a Phase III trial in Europe in combination with radiation for the treatment of pediatric pontine glioma and a Phase I/II trial in a specific population of patients with non-small cell lung cancer in Canada.
AeroLEF(TM) is a unique inhaled-delivery composition of free and liposome encapsulated fentanyl, for the treatment of moderate to severe acute pain, including cancer pain. AeroLEF(TM) is currently enrolling post-surgical patients in a randomized Phase IIb trial.
Norelin, an anti-cancer vaccine, stimulates the immune system to develop antibodies to gonadotropin-releasing hormone (GnRH). In addition, YM BioSciences owns a portfolio of pre-clinical compounds. |
