MISSISSAUGA, ON, Sept. 22 /PRNewswire-FirstCall/ - YM BioSciences Inc. , 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(R) (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(R) (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.
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 the pivotal tesmilifene Phase III trial will be completed on schedule and yield mature data in calendar 2007; that the DSMB's recommendations to continue the pivotal trial for tesmilifene based on two early analyses implies that the trial continues to have the prospect of meeting its primary endpoint; that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; 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.
Summary financial statements attached: YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Balance Sheets (Amounts in Canadian dollars, unless otherwise noted) June 30, 2006 and 2005 ------------------------------------------------------------------------- 2006 2005 ------------------------------------------------------------------------- Assets Current assets: Cash and cash equivalents $ 2,735,317 $ 686,373 Short-term deposits 85,606,117 29,882,472 Marketable securities - 4,834 Accounts receivable 2,214,775 1,591,712 Prepaid expenses 318,338 159,661 ------------------------------------------------------------------------- 90,874,547 32,325,052 Capital assets 304,985 226,698 Intangible assets 8,868,528 5,648,141 ------------------------------------------------------------------------- $ 100,048,060 $ 38,199,891 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 2,367,042 $ 2,995,457 Accrued liabilities 1,350,923 830,158 Deferred revenue 738,297 206,770 ----------------------------------------------------------------------- 4,456,262 4,032,385 Long-term portion of deferred revenue 844,275 327,387 Shareholders' equity: Share capital 172,771,544 87,487,802 Share purchase warrants 4,597,988 5,313,283 Contributed surplus 3,944,492 1,790,928 Deficit accumulated during the development stage (86,566,501) (60,751,894) ----------------------------------------------------------------------- 94,747,523 33,840,119 Basis of presentation Commitments Subsequent event ------------------------------------------------------------------------- $ 100,048,060 $ 38,199,891 ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Statements of Operations and Deficit Accumulated During the Development Stage (Amounts in Canadian dollars, unless otherwise noted) ------------------------------------------------------------------------- From inception on August 17, 1994 Years ended June 30, to June 30, 2006 2005 2004 2006 ------------------------------------------------------------------------- Revenue $ 1,151,135 $ 748,020 $ - $ 1,899,155 Interest income 1,397,558 703,873 347,187 4,889,849 ------------------------------------------------------------------------- 2,548,693 1,451,893 347,187 6,789,004 Expenses: General and admini- strative 7,951,470 6,314,357 3,610,848 29,099,199 Licensing and product development 20,188,577 10,981,950 5,066,569 62,046,914 ----------------------------------------------------------------------- 28,140,047 17,296,307 8,677,417 91,146,113 ------------------------------------------------------------------------- Loss before the undernoted (25,591,354) (15,844,414) (8,330,230) (84,357,109) Loss on foreign exchange (220,630) - - (220,630) Gain (loss) on marketable securities (2,623) - 638,332 (1,191,329) Unrealized loss on marketable securities - (14,881) - - ------------------------------------------------------------------------- Loss before income taxes (25,814,607) (15,859,295) (7,691,898) (85,769,068) Income taxes - - - 7,300 ------------------------------------------------------------------------- Loss for the period (25,814,607) (15,859,295) (7,691,898) (85,776,368) Deficit, beginning of period (60,751,894) (44,319,267) (36,470,665) - Cost of purchasing shares for cancellation in excess of book value - (573,332) (156,704) (790,133) ------------------------------------------------------------------------- Deficit, end of period $ (86,566,501) $ (60,751,894) $ (44,319,267) $ (86,566,501) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share $ (0.59) $ (0.47) $ (0.36) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding 43,755,160 34,046,450 21,353,479 Excludes common shares held in escrow for contingent additional payment related to the acquisition of Delex Therapeutics Inc. 2,380,953 2,777,778 - ------------------------------------------------------------------------- ------------------------------------------------------------------------- YM BIOSCIENCES INC. (A DEVELOPMENT STAGE COMPANY) Consolidated Statements of Cash Flows (Amounts in Canadian dollars, unless otherwise noted) ------------------------------------------------------------------------- From inception on August 17, 1994 Years ended June 30, to June 30, 2006 2005 2004 2006 ------------------------------------------------------------------------- Cash provided by (used in): Operating activities: Loss for the period $ (25,814,607) $ (15,859,295) $ (7,691,898) $ (85,776,368) Items not involving cash: Depre- ciation of capital assets 61,017 11,717 14,910 331,681 Amorti- zation of intangible assets 1,269,158 137,760 - 1,406,918 Unrealized loss on marketable securities - 14,881 - 1,827,038 Loss (gain) on marketable securities 2,623 - (638,332) (635,709) Stock-based compen- sation 2,588,413 1,278,955 500,375 4,436,563 Stock-based consider- ation 100,000 192,750 - 292,750 Warrants- based consider- ation 54,775 - - 54,775 Change in non-cash operating working capital: Accounts receivable and prepaid expenses (672,639) (367,916) (295,651) (1,504,391) Accounts payable and accrued liabilities and deferred revenue (1,599,032) 2,396,216 841,128 2,058,895 ------------------------------------------------------------------------- (24,010,292) (12,194,932) (7,269,468) (77,507,848) Financing activities: Repayment of debentures - (1,469,425) - (1,469,425) Issuance of common shares on exercise of options 851,322 109,318 1,544,375 2,505,014 Issuance of common shares on exercise of warrants 3,627,430 432,402 222,348 4,282,180 Redemption of preferred shares - - - (2,630,372) Purchase of shares for cancellation - (779,909) (230,379) (1,029,679) Net proceeds from issuance of shares and warrants 42,622,618 18,884,120 17,047,001 123,276,729 ------------------------------------------------------------------------- 47,101,370 17,176,506 18,583,345 124,934,447 Investing activities: Short-term deposits, net (55,529,720) (14,988,521) (14,893,951) (85,412,192) Proceeds on sale of marketable securities 2,211 - 1,402,239 1,404,450 Additions to capital and intangible assets (54,791) (27,034) (3,724) (450,153) ------------------------------------------------------------------------- (55,582,300) (15,015,555) (13,495,436) (84,457,895) ------------------------------------------------------------------------- Decrease in cash and cash equivalents (32,491,222) (10,033,981) (2,181,559) (37,031,296) Net cash assumed on acquisition 34,540,166 5,226,447 - 39,766,613 Cash and cash equivalents, beginning of period 686,373 5,493,907 7,675,466 - ------------------------------------------------------------------------- Cash and cash equivalents, end of period $ 2,735,317 $ 686,373 $ 5,493,907 $ 2,735,317 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Non-cash items: Issuance of common shares on Delex acqui- sition $ 1,464,284 $ 9,862,697 $ - $ 11,326,981 Issuance of common shares on Eximias acquisition 35,063,171 - - 35,063,171 ------------------------------------------------------------------------- -------------------------------------------------------------------------
YM BioSciences Inc.CONTACT: Enquiries: Thomas Fechtner, The Trout Group LLC, Tel. (212)477-9007 x31, Fax (212) 460-9028, Email: tfechtner@troutgroup.com; JamesSmith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416)815-0080, Email: jsmith@equicomgroup.com
