YM BIOSCIENCES REPORTS FISCAL YEAR END 2008 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, Sept. 19 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX:
YM, AIM: YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today reported
operational and financial results for its fiscal 2008 year end, ended June 30,
2008.
"The critical highlight of the year was the confirmation that nimotuzumab
differs mechanistically from the currently marketed EGFR-targeting monoclonal
antibodies, cetuximab and panitumumab. This mechanistic information supported
by recent clinical data, provides us with a clear path-to-market for
nimotuzumab," said David Allan, Chairman and CEO of YM BioSciences. "Recent
work has demonstrated that, in circumstances where EGFR-expression is moderate
to high, or where its density may be enhanced, as in radiation-containing
regimens, our antibody is effective without the debilitating and dangerous
Grade III/IV side-effects associated with cetuximab treatment. Nimotuzumab's
path-to-market in North America is in two indications in which there is an
unmet medical need - palliative non-small-cell lung cancer and in brain
metastases - for both of which indications we have supportive clinical
evidence, patient populations are substantial and the markets uncrowded. Our
licensees in the rest of the world have defined strategies and, in Europe, the
drug is in a number of late-stage, registration trials."
Nimotuzumab highlights
Nimotuzumab is being developed to compete as best-in-class against the
currently marketed EGFR-targeting drugs. This drug has displayed efficacy in
numerous clinical trials with anti-cancer activity that rivals the other
EGFR-targeting antibody drugs. However, in none of its trials to date, to YM's
knowledge, have any of the patients treated with nimotuzumab had Grade III/IV
rash, a severe and dose-limiting side-effect observed in all of the other
antibodies and small molecules targeting the EGF tyrosine kinase signaling
pathway. Reports of any severe incidents of the other side-effects that are
typical of EGFR-targeting molecules have been rare and, unlike cetuximab,
nimotuzumab patients do not have to be pre-medicated.
Results of the first trial of nimotuzumab in combination with irinotecan
in irinotecan-refractory colorectal cancer patients were recently reported
with the disease control rate (DCR) from the addition of nimotuzumab being
similar to that reported for cetuximab in similar trials. The nimotuzumab
treated patients exhibited no debilitating rash and the cetuximab patients
demonstrated a higher response rate. Since DCR has been established as a
significantly more powerful predictor of survival than RR, the similar overall
survival times seen with these two antibodies in this condition are,
therefore, not surprising.
YM and its direct licensees have studies underway and others in planning
that investigate nimotuzumab in settings where regimens that stimulate EGFR
activated expression are used, such as radiation or chemoradiation:
- In Europe, data from the fully recruited Phase III trial of
nimotuzumab combined with radiation therapy in the first-line
treatment for children with inoperable brain cancer conducted by our
licensee, Oncoscience AG, could be submitted to the EMEA for
marketing approval during calendar 2009, as a Type II Variation
should the submission that has been made to EMEA in late 2007 be
accepted.
- Oncoscience also continues to enrol patients in a Phase III study in
adult glioma treated with temozolomide and radiation therapy
+/- nimotuzumab.
During fiscal 2008, YM and its licensees achieved the following:
- YM received clearance from the FDA to initiate a clinical trial
evaluating nimotuzumab as a monotherapy in children with diffuse,
intrinsic pontine glioma (DIPG), an inoperable, treatment-resistant
brain cancer. This was followed the granting of a Special License to
YM USA by the US Treasury's Office of Foreign Assets Control (OFAC).
In February 2008, YM enrolled the first patient in the 44-patient
single-arm trial, initially limited by OFAC to six leading
US pediatric clinical centers, but now unlimited, and at two Canadian
centers. Recruitment is expected to be completed in late calendar
2009. Nimotuzumab is also available to patients in the US under an
Expanded Access Program.
- In Japan, YM licensee, Daiichi-Sankyo Co., Ltd., completed
preliminary safety trials with nimotuzumab and has advised that it
plans to evaluate the drug in more advanced trials.
- In Europe, Oncoscience continued to enrol patients in a
Phase IIb/IIIa randomized trial in advanced pancreatic cancer that
compares gemcitabine alone to gemcitabine plus nimotuzumab, designed
to be supportive of registration. In June 2008 nimotuzumab was
accorded Orphan Drug Designation for pancreatic cancer in Europe.
- In August 2008, YM's licensee in Singapore/Indonesia,
Innogene Kalbiotech/P.T. Kalbe Farma (IGK) received approval for
nimotuzumab for marketing in the Philippines and, in addition, has
initiated a Special Access Program in IGK's substantial markets where
a broad development program is underway. IGK is the sponsor for a
Phase II trial in locally advanced head and neck cancer (radiation +
nimotuzumab) being conducted by the internationally recognized
National Cancer Center of Singapore.
- YM presented data at ASCO 2008 from the Canadian arm of a fully
recruited Phase I palliative trial in non-small-cell lung cancer
(NSCLC) being conducted in Canada by YM and in Korea by
Kuhnil Pharmaceutical Co. suggesting that the combination of
nimotuzumab with radiation has the potential to provide an important
survival advantage to patients over radiation alone in the curative
setting.
- Subsequent to the end of fiscal 2008, the Company reported
preliminary results obtained from its open-label, Phase II study of
nimotuzumab in patients with irinotecan-refractory, metastatic
colorectal cancer. The overall survival and disease control rate for
the 58 evaluable patients receiving nimotuzumab compared well with
published results in similar patient populations treated with
cetuximab. However, as with all previous trials, nimotuzumab
continued to display a safety profile unequalled in its class.
AeroLEF(R)
AeroLEF(R) is a novel approach to the treatment of pain with an approved
drug which positions this product within a precedent context for its
prospective approval. The intellectual property relates to the composition of
free and liposome-encapsulated opioid - in this case fentanyl - which is
inhaled through a widely-available, FDA-approved nebulizer. The inhalation of
the free fentanyl produces very rapid onset of pain relief and the liposome
encapsulated proportion results in an extended duration of analgesia, thus
differentiating AeroLEF(R) from other fentanyl products in the marketplace.
AeroLEF(R) has successfully completed a randomized Phase IIb trial and is now
positioned for later-stage development.
During fiscal 2008:
- In May 2008, three posters were presented at the Annual Meeting of
the American Pain Society reporting results from previous clinical
trials including a randomized, placebo-controlled Phase IIb trial
enrolling opioid-naive patients with postoperative pain following
orthopedic surgery, where AeroLEF(R) demonstrated a statistically
significant difference in pain relief and pain intensity to placebo
(p(equal sign)0.0194). All the posters referred to both the safety
and efficacy of the product.
- In June 2007, the FDA cleared the first Phase II protocol to proceed
with an AeroLEF(R) trial in the US. An amended protocol, submitted in
2008, has since been cleared.
- YM put in place a strengthened team with extensive experience
developing fentanyl-based pain products, lead by Dr. Ali Raza,
appointed President of the AeroLEF(R) division and supported by
Elizabeth Jenkins, a UK-based regulatory expert. Under Dr. Raza's
leadership, the Company plans to meet with European regulators in the
coming months to solidify trial designs for registration of this
product.
Financial Results (CDN dollars)
Total revenue for the fiscal year ended June 30, 2008 was $7.4 million
compared with $7.6 million for fiscal 2007. Total revenue for the fourth
quarter of fiscal 2008 was $2.0 million compared with $1.9 million for the
fourth quarter of fiscal 2007. Revenue from out-licensing was $4.9 million for
fiscal 2008 compared with $4.4 million for fiscal 2007. The most significant
agreement, signed with Daiichi Pharmaceutical Co., Ltd. in July 2006, licensed
the commercial rights for nimotuzumab for Japan and included a non-refundable
up-front payment from Daiichi to the Company of $16.2 million. This initial
license fee has been recorded as deferred revenue and is being recognized over
a period of four years. Interest income for fiscal 2008 was $2.6 million
compared with $3.2 million for fiscal 2007. Interest income is decreasing as
the Company draws on its cash balances to fund its operations.
Total operating expenditures for the fiscal year ended June 30, 2008 were
$22.5 million compared to $37.6 million for the fiscal year ended June 30,
2007. Total operating expenditures for the fourth quarter ended June 30, 2008
were $4.9 million compared to $6.5 million for the same quarter in 2007.
General and administrative expenses decreased to $6.8 million in fiscal 2008
compared to $7.0 million in fiscal 2007. Licensing and product development
expenses for the year ended June 30, 2008 decreased by $13.1 million compared
to the year ended June 30, 2007. The large decreases are mainly the result of
reduced development activity for tesmilifene, for which a Phase III trial was
terminated in January 2007. Costs associated with development activities for
nimotuzumab decreased to $5.2 million for the fiscal year ended June 30, 2008
compared to $5.9 million for the year ended June 30, 2007. Costs associated
with development activities for AeroLEF(R) decreased to $2.0 million for the
fiscal year ended June 30, 2008 compared to $2.9 million for the year ended
June 30, 2007. Costs related to development activities for tesmilifene for the
year ended June, 2008 decreased to $1.3 million compared to $7.5 million for
the comparable period last year.
In addition to the specific licensing and product development costs,
there was a significant decrease in licensing and product development salary
expenses. Salary expenses, including termination costs, were $2.0 million less
in fiscal 2008 compared to fiscal 2007 as the Company reduced development
staff following the termination of the Phase III DEC study for tesmilifene in
February 2007.
Net losses for the fiscal year and fourth quarter ended June 30, 2008
were $14.9 million ($0.27 per share) and $3.0 million ($0.05 per share)
respectively compared to $31.7 million ($0.57 per share) and $4.7 million
($0.09 per share) for the same periods last year.
As at June 30, 2008 the Company had cash and cash equivalents and
short-term deposits totaling $58.1 million and payables and accrued
liabilities totaling $2.0 million compared to $75.6 million and $3.3 million
respectively at June 30, 2007.
As at June 30, 2008 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.,
5,709,765 warrants, and 5,633,102 options.
The Company's annual financial statements and management's discussion and
analysis will be available on www.sedar.com, www.edgar.com and at
www.ymbiosciences.com.
About YM BioSciences
YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
eight countries, is significantly differentiated from all other currently
marketed EGFR-targeting agents because of a remarkably benign side-effect
profile. In approximately 3,000 patients treated, to date, worldwide no Grade
III/IV rash has been reported and reports of any of the other side-effects
that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in
development for the treatment of moderate to severe pain, including cancer
pain. The product completed a randomized trial in 2007 and is being prepared
for late-stage development internationally.
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(R) 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.
YM BIOSCIENCES INC.
Consolidated Balance Sheets
(Amounts in Canadian dollars, unless otherwise noted)
June 30, 2008 and 2007
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2008 2007
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Assets
Current assets:
Cash and cash equivalents $ 3,119,189 $ 5,847,351
Short-term deposits 54,981,737 69,724,438
Accounts receivable 403,371 370,011
Prepaid expenses 375,133 347,010
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58,879,430 76,288,810
Property and equipment 128,400 325,040
Intangible assets 4,065,409 5,125,950
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$ 63,073,239 $ 81,739,800
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 307,588 $ 1,169,211
Accrued liabilities 1,715,024 2,103,755
Deferred revenue 4,623,340 4,702,132
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6,645,952 7,975,098
Deferred revenue 4,414,256 8,929,900
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants 3,150,539 4,553,308
Contributed surplus 9,123,824 5,657,082
Deficit (133,182,485) (118,296,741)
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52,013,031 64,834,802
Basis of presentation
Commitments
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$ 63,073,239 $ 81,739,800
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YM BIOSCIENCES INC.
Consolidated Statements of Operations and Comprehensive Loss and Deficit
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
Years ended June 30,
2008 2007 2006
-------------------------------------------------------------------------
Out-licensing revenue $ 4,859,085 $ 4,407,890 $ 1,151,135
Interest income 2,584,080 3,239,540 1,397,558
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7,443,165 7,647,430 2,548,693
Expenses:
General and administrative 6,831,955 6,978,336 7,951,470
Licensing and product
development 15,631,550 28,758,469 20,188,577
Impairment of intangible
assets - 1,829,538 -
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22,463,505 37,566,343 28,140,047
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Loss before the undernoted (15,020,340) (29,918,913) (25,591,354)
Gain (loss) on foreign
exchange 32,463 (142,552) (220,630)
Realized gain on short-term
deposits 126,588 - -
Unrealized gain on short-term
deposits 45,688 - -
Loss on marketable securities - - (2,623)
Loss on disposal of property
and equipment (70,143) - -
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Loss before income taxes (14,885,744) (30,061,465) (25,814,607)
Income taxes - 1,668,775 -
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Loss and comprehensive loss
for the year (14,885,744) (31,730,240) (25,814,607)
Deficit, beginning of year (118,296,741) (86,566,501) (60,751,894)
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Deficit, end of year $(133,182,485) $(118,296,741) $ (86,566,501)
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Basic and diluted loss per
common share $ (0.27) $ (0.57) $ (0.59)
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Weighted average number of
common shares outstanding 55,835,356 55,804,674 43,755,160
Excludes common shares held
in escrow for contingent
additional payment related
to the acquisition of
Delex Therapeutics Inc. 2,380,953 2,380,953 2,380,953
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YM BIOSCIENCES INC.
Consolidated Statements of Cash Flows
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
Years ended June 30,
2008 2007 2006
-------------------------------------------------------------------------
Cash provided by (used in):
Operating activities:
Loss for the year $ (14,885,744) $ (31,730,240) $ (25,814,607)
Items not involving cash:
Depreciation of property
and equipment 125,271 107,107 61,017
Amortization of
intangible assets 1,060,541 1,913,040 1,269,158
Impairment of intangible
assets - 1,829,538 -
Loss on disposal of
property and equipment 70,143 - -
Loss on sale of marketable
securities - - 2,623
Stock-based compensation 2,063,973 1,716,913 2,588,413
Stock-based consideration - - 100,000
Warrants-based
consideration - - 54,775
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses (61,483) 1,816,092 (672,639)
Accounts payable, accrued
liabilities and deferred
revenue (5,844,790) 11,604,460 (1,599,032)
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(17,472,089) (12,743,090) (24,010,292)
Financing activities:
Issuance of common shares
on exercise of options - 11,232 851,322
Issuance of common shares
on exercise of warrants - 89,375 3,627,430
Net proceeds from issuance of
shares and warrants - - 42,622,618
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- 100,607 47,101,370
Investing activities:
Short-term deposits, net 14,742,701 15,881,679 (55,529,720)
Proceeds on sale of
marketable securities - - 2,211
Additions to property and
equipment (37,770) (127,162) (54,791)
Proceeds on sale of
property and equipment 38,996 - -
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14,743,927 15,754,517 (55,582,300)
Increase (decrease) in cash
and cash equivalents (2,728,162) 3,112,034 (32,491,222)
Net cash assumed on
acquisition - - 34,540,166
Cash and cash equivalents,
beginning of year 5,847,351 2,735,317 686,373
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Cash and cash equivalents,
end of year $ 3,119,189 $ 5,847,351 $ 2,735,317
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-------------------------------------------------------------------------
Non-cash items:
Issuance of common shares
on Delex acquisition $ - $ - $ 1,464,284
Issuance of common shares
on Eximias acquisition - - 35,063,171
Issuance of common shares
in exchange for licensed
patents - - 100,000
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For further information: Thomas Fechtner, the Trout Group LLC, Tel. (646)
378-2931, Email: tfechtner(at)troutgroup.com; James Smith, the Equicom Group
Inc., Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
(YM. YMI YMBA)
END
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