- Helix announced that it has completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with L-DOS47. These studies demonstrated a good safety profile in an expanded number of rodent and primate test animals, building upon Helix's positive findings from its preliminary non-GLP toxicology studies.
- Helix announced the filing of an investigational new drug application with the U.S. Food and Drug Administration ("FDA"), seeking approval to perform a planned Phase II/III efficacy trial of Topical interferon Alpha-2b in patients with low-grade cervical lesions, which is currently on clinical hold pending further review by the FDA.
- Further announced positive safety and efficacy findings from its Phase II PK study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.
- Completed a private placement financing on August 6, 2010 for net proceeds of $9,457,000.
- Trading of Helix common stock commenced on the NYSE Amex stock exchange.
- Subsequent to the Company's fiscal Q1 2011, Helix entered into an agreement to transfer world-wide Klean-Prep® rights, except Canada, to Helsinn Birex Pharmaceuticals Limited. The parties also entered into a new supply agreement where Helsinn will supply Klean-Prep® to Helix with terms extending over a ten year period, subject to certain performance conditions. Helix will retain the Canadian rights to Klean-Prep® and continue to distribute the product in Canada.
- Helix exclusively retained US investor relations firm, Consulting for Strategic Growth 1 Ltd.
Consolidated Balance Sheets as at
(thousand $)
31-Oct 31-Jul
2010 2010
--------- ---------
Current assets:
Cash and cash equivalents 19,525 13,125
Accounts receivable 1,461 1,365
Inventory 787 780
Prepaid and other 247 398
--------- ---------
22,020 15,668
Non current assets 2,348 2,446
--------- ---------
Total assets 24,368 18,114
========= =========
31-Oct 31-Jul
2010 2010
--------- ---------
Current liabilities:
Accounts payable 1,565 1,435
Accrued liabilities 363 821
Deferred lease credit 25 25
--------- ---------
1,953 2,281
Non current liabilities 66 72
--------- ---------
Total liabilities 2,019 2,353
Shareholders' equity 22,349 15,761
--------- ---------
Total liabilities & Shareholders' Equity 24,368 18,114
========= =========
The Company's unaudited interim consolidated Statements of Operations and
Cash Flows for the three month periods ended October 31, 2010 and 2009 are
summarized below:
Consolidated Statements of Operations
for the three month period ended October 31
(thousand $, except for per share data)
2010 2009
-------- --------
Revenue:
Product revenue 1,105 903
License fees & royalties 100 117
-------- --------
1,205 1,020
Expenses:
Cost of sales 414 418
Research and development 2,401 2,925
Operating, general and admin 976 677
Sales and marketing 258 261
Amortization of capital assets 107 98
Stock-based compensation 694 160
Interest income (50) (14)
Foreign exchange (gain) (35) (42)
-------- --------
4,765 4,483
Loss before income taxes (3,560) (3,463)
Income taxes 3 10
-------- --------
Loss for the year (3,563) (3,473)
======== ========
Loss per share:
Basic and diluted (0.06) (0.06)
-------- --------
Consolidated Statements of Cash Flows
for the three month period ended October 31
(thousand $, except for per share data)
2010 2009
-------- --------
Cash provided by (used in):
Loss for the year (3,563) (3,473)
Items not involving cash:
Amortization of capital assets 107 98
Deferred lease credit (6) (8)
Stock-based compensation 694 160
Foreign exchange (gain) (35) (42)
-------- --------
(2,803) (3,265)
Change in non-cash
working capital (280) 917
-------- --------
Operating activities (3,083) (2,348)
Financing activities 9,457 11,597
Investing activities (9) (245)
Effect of exchange rate changes
on cash and cash equivalents 35 42
-------- --------
Cash and cash equivalents:
Increase in the year 6,400 9,046
Beginning of the year 13,125 14,494
-------- --------
End of the year 19,525 23,540
======== ========
The Company's unaudited interim consolidated financial statements and
management's discussion and analysis of financial condition and results of
operations have been filed, today, with Canadian securities regulatory
authorities and will be available at SEDAR at www.sedar.com
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company specializing in the
field of cancer therapy. The Company is actively developing innovative
products for the prevention and treatment of cancer based on its
proprietary technologies. Helix's product development initiatives include
its novel L-DOS47 new drug candidate and its Topical Interferon Alpha-2b.
Helix is listed on the TSX, NYSE Amex and FSE under the symbol "HBP".
Forward-Looking Statements and Risks and Uncertainties
This News Release contains certain forward-looking statements and
information (collectively, "forward-looking statements") within the meaning
of applicable securities laws, regarding the development of products by
Helix for the prevention and treatment of cancer based on its proprietary
technologies, sufficiency of the Company's cash reserves and expected cash
flow from operations; seeking additional financing, and other information
in future periods. Although Helix believes that the expectations reflected
in such forward-looking statements are reasonable, such statements involve
risks and uncertainties, and undue reliance should not be placed on such
statements. Certain material factors or assumptions are applied in making
forward-looking statements, including, but not limited to, receipt of
necessary additional funding, strategic partner support and regulatory
approvals; GMP manufacturing and other activities; the timely provision of
services and performance of contracts by third parties; the successful and
timely closing of the transfers of certain Klean-Prep® rights to Helsinn,
and future revenue, costs and expenditures. Helix's actual results could
differ materially from those anticipated in these forward-looking
statements as a result of numerous risks and uncertainties including
without limitation, Helix's need for additional capital, which may not be
available; uncertainty whether the Company's products under development,
including L-DOS47 and Topical Interferon Alpha-2b, will be successfully
developed and commercialized; uncertainty whether clinical trials will
proceed as planned or at all, and the risk that clinical trial results may
be negative; uncertainty whether the transfers of certain Klean-Prep®
rights to Helsinn will occur in a timely manner or at all; insurance and
intellectual property risks; research and development risks; the need for
further regulatory approvals, which may not be obtained; the Company's
dependence on its third-party service providers; upscaling and
manufacturing risks; partnership / strategic alliance risks; the effect of
competition; the risk of technical obsolescence; uncertainty of the size
and existence of a market opportunity for Helix's products; uncertainty
whether the Company will be able to obtain an appropriate pharmaceutical or
strategic partner for the drug candidates, which are not assured; changes
in business strategy or plans; and the risk factors that are discussed
under Item 3.D. - "Risk Factors" in the Company's latest Form 20-F Annual
Report or identified in the Company's other public filings with the
Canadian Securities Administrators at www.sedar.com or with the SEC at
www.sec.gov. Forward-looking statements and information are based on the
beliefs, assumptions and expectations of Helix's management at the time
they are made, and Helix does not assume any obligation to update any
forward-looking statement or information should those beliefs, assumptions
or expectations, or other circumstances change, except as required by law.
Contact Information: For further information contact: Investor Relations: Stanley Wunderlich Consulting for Strategic Growth 1 Ltd. Tel: 800-625-2236 ext. 7770 Email: Web Site: www.cfsg1.com Media Relations: Richard Stern Stern & Co. Tel: 212 888-0044 Email: Web Site: www.sternco.com