Helix BioPharma Corp. Announces Fiscal Q1 2014 Results
AURORA, ON--(Marketwired - Dec 13, 2013) - Helix BioPharma Corp.
(TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing
drug candidates for the prevention and treatment of cancer, today
announced financial results for the three-month period ended
October 31, 2013.
HIGHLIGHTS
During the first fiscal quarter of 2014, the Company
announced:
- On December 5, 2013 the termination of John Docherty, the
Company's President and Chief Operating Officer.
- On November 4, 2013, the closing of a private placement for net
proceeds in excess of $4,600,000. The terms of the private
placement ("Private Placement") are for the purchase of common
shares at $1.15 per share and include one warrant per share at an
exercise price of $1.61 with an expiry of five years from the date
of issue.
- On October 15, 2013, the completion of an interim review of
data collected to date, for its European Phase I/II clinical study
of L-DOS47. See "L-DOS47" below under the heading
"Research and Development Update".
- On August 28, 2013, the establishment of Helix Polska Sp. z
o.o., further strengthening Canadian-Polish relationships and
scientific collaboration which began in 2005, when Polish investors
first became shareholders of the Company;
- On August 9, 2013, the approval by the TSX, to extend the
expiry date of the 2010 warrants by 18 months, from August 5, 2013
to February 5, 2015, in addition to amending the exercise price
from $3.40 to $4.15. No other provisions of the 2010 warrants
were amended. The Company subsequently received approval from
the TSX to extend the expiry date of the 2009 warrants by 12
months, from September 7, 2013 to September 7, 2014 in addition to
amending the exercise price from $2.87 to $3.51. No other
provisions of the 2009 warrants were amended.
RESEARCH AND DEVELOPMENT UPDATE
L-DOS47
On May 14, 2012, the Company commenced clinical site initiations
and patient recruitment activities for its European Phase I/II
clinical study of L-DOS47 in Poland. Since the dosing of the
first patient in Cohort 1 on October 23, 2012, the Company remains
on target to achieve its milestone of completing the Phase I
component of the European Phase I/II clinical study by the summer
of 2014. As previously disclosed, the Company estimates that
the Phase I component of the study will enroll into 8
Cohorts. As at December 12, 2013 a total of 15 patients have
been dosed and the study is currently dosing patients in Cohort
5.
During the quarter, the Company conducted an interim data review
of the first four cohorts for this study. The interim data
review found that L-DOS47 was well tolerated for all patients
treated within all cohorts and that none of the treatment related
adverse events reported to date had met the definition of a
dose-limiting toxicity. In addition, no infusion or anaphylactic
reactions have been reported and that any adverse events reported
as of that date were those normally expected for the population
under study.
In addition, the Company is currently re-evaluating the U.S.
Phase I protocol previously approved by the U.S. Food and Drug
Administration ("FDA") and is preparing to file either an amendment
or a new protocol for approval by the FDA.
Even after the Private Placement, the Company does not have
sufficient cash resources to see the entire European Phase I/II
clinical study nor the U.S. Phase I study if approved by the FDA
through to completion, though the Company does expect to have
sufficient cash following the closing of the Private Placement to
complete the European Phase I portion of the clinical study,
provided the Company does not experience any unforeseen
expenditures.
Topical Interferon Alpha-2b
After agreeing to terminate the contractual arrangement on
December 12, 2014, with Merck Sharp & Dohme Corp ("Merck"), the
Company's primary and ongoing focus, as it relates to the Topical
Interferon Alpha-2b program, has been on sourcing and qualifying
alternative interferon alpha-2b raw material samples, and finding
suitable strategic partner(s) who would be willing to license or
acquire the product and supports the remaining development costs
through to commercial launch. As a result, the Company has
hired an outside consultant to assist it in finding a suitable
strategic partner(s).
To date, the Company has completed preliminary quality testing,
comparing alternate raw material samples to its approved drug
substance specification and a potential new supplier of the
interferon alpha-2b raw material necessary to formulate the product
candidate has been identified. However, further quality
testing and evaluation of this material and its supplier, as well
as negotiation of supply terms acceptable to the Company and
receipt of necessary regulatory approvals will be necessary before
the Company will be in a position to definitively verify raw
material comparability with the interferon alpha-2b originally
supplied by Merck.
The continuation of the Topical Interferon Alpha-2b program more
generally is dependent on a strategic partner(s) providing
additional funding.
FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of
$2,137,000 ($0.03 loss per common share) and $2,077,000 ($0.03 loss
per common share) for the three-month periods ended October 31,
2013 and 2012, respectively.
The net loss and comprehensive loss of $2,077,000 for the
three-month period ended October 31, 2012 included net income from
discontinued operations totaling $323,000 (three-month period ended
October 31, 2013 - nil). The Company announced the sale of its
distribution business in Canada, on January 25, 2013.
Research and development
Research and development costs for the three-month periods ended
October 31, 2013 and 2012 totalled $1,332,000 and $1,608,000,
respectively.
L-DOS47 research and development expenses for the three-month
periods ended October 31, 2013 and 2012 totalled $650,000 and
$822,000, respectively. These L-DOS47 research and development
expenditures relate primarily to expenditures associated with the
ongoing European Phase I/II clinical study in Poland. The
higher L-DOS47 research and development expenses in the comparative
three-month period ended October 31, 2012 reflect higher costs
associated with the initial ramping up of the European Phase I
clinical study which is now well advanced. The Company remains
on target with its milestone of completing the Phase I component of
the European Phase I/II clinical study by the summer of 2014.
Topical Interferon Alpha-2b research and development expenses
for three-month periods ended October 31, 2013 and 2012 totalled
$114,000 and $413,000, respectively. Beginning in June 2012,
the Company initiated a downsizing of the staff in the Saskatoon
laboratory which ultimately resulted in the close of the facility
in November 2012. The Company has now limited ongoing
activities relating to Tropical Interferon Alpha-2b, to sourcing
and qualifying alternative interferon alpha-2b raw material
samples, strengthening the BiPhasix™ patent portfolio and finding
suitable strategic partner(s) who would be willing to license or
acquire the product and support the remaining development costs
through to commercial launch.
The Company also incurs corporate research and development
expenses. Corporate research and development expenses for
three-month periods ended October 31, 2013 and 2012 totalled
$281,000 and $235,000, respectively with the increase mainly the
result of the hiring by the Company of a Director of Clinical
Studies to oversee the conduct of the Company's clinical
trials.
Trademark and patent related expenses for the three-month
periods ended October 31, 2013 and 2012 totalled $225,000 and
$11,000, respectively. The Company has increased its efforts
to strengthen the BiPhasix™ and DOS47 patent portfolio.
Operating, general and administration
Operating, general and administration expenses for the
three-month periods ended October 31, 2013 and 2012 totalled
$826,000 and $764,000, respectively. Slightly higher operating,
general and administration expenses are the result of higher legal
and travel expenses which are attributable in part to the number of
initiatives being pursued by the Company.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash reserves of $2,482,000 as at October 31, 2013
are insufficient to meet anticipated cash needs for working capital
and capital expenditures through the next twelve months, nor are
they sufficient to see the current research and development
initiates through to completion. On November 4, 2013,
subsequent to the Company fiscal quarter ending October 31, 2013,
the Company closed a private placement for net proceeds in excess
of $4,600,000.To the extent that the Company does not believe it
has sufficient liquidity to meet its current obligations,
management considers securing additional funds, primarily through
the issuance of equity securities of the Company, to be of the
utmost importance.
The Company's condensed unaudited interim consolidated statement
of financial position as at October 31, 2013 and July 31, 2013 are
summarized below:
|
|
Consolidated Statement of Financial
Position (thousand $) |
|
|
|
|
|
|
|
October 31 2013 |
|
July 31 2013 |
|
|
|
|
|
Non current assets |
|
623 |
|
677 |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Prepaids |
|
111 |
|
139 |
|
Accounts receivable |
|
474 |
|
559 |
|
Cash |
|
2,482 |
|
4,493 |
|
|
3,067 |
|
5,191 |
|
|
|
|
|
Total assets |
|
3,690 |
|
5,868 |
|
|
|
|
|
Shareholders' equity |
|
2,811 |
|
4,920 |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Deferred lease credit |
|
17 |
|
23 |
|
Accrued liabilities |
|
308 |
|
621 |
|
Accounts payable |
|
554 |
|
304 |
|
|
879 |
|
948 |
|
|
|
|
|
Total liabilities & shareholders equity |
|
3,690 |
|
5,868 |
|
|
|
|
|
|
|
|
|
|
The Company's condensed unaudited interim consolidated statement
of net loss and comprehensive loss for the three-month periods
ending October 31, 2013 and 2012 and the condensed unaudited
interim consolidated statement of cash flows for the three-month
periods ending October 31, 2013 and 2012 are summarized below:
|
|
Consolidated Statements of Net Loss and
Comprehenisve Loss |
(thousand
$, except for per share data) |
|
|
|
Oct-31 2013 |
|
|
Oct-31 2012 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,332 |
|
|
|
1,608 |
|
|
Operating, general & administration |
|
|
826 |
|
|
|
764 |
|
|
|
|
|
|
|
|
|
|
Results from operating activities before finance
items |
|
|
(2,158 |
) |
|
|
(2,372 |
) |
|
|
|
|
|
|
|
|
|
Finance items |
|
|
21 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss and total comprehensive loss from continuing
operations |
|
|
(2,137 |
) |
|
|
(2,400 |
) |
|
|
|
|
|
|
|
|
|
Net income and total comprehensive income from
discontinued operations |
|
|
- |
|
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and total comprehensive loss |
|
|
(2,137 |
) |
|
|
(2,077 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share from continuing operations * |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
Income per share from discontinued operations * |
|
$ |
- |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total loss per common share * |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Figures are for both basic and fully diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Cash Flows (thousand
$) |
(thousand
$) |
|
|
|
|
Oct-31 2013 |
|
|
Oct-31 2012 |
|
|
|
|
|
|
|
|
Cash provided by (used in): |
|
|
|
|
|
|
|
Net
loss and total comprehensive loss |
|
(2,137 |
) |
|
(2,400 |
) |
|
|
|
|
|
|
|
Items not involving cash: |
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
54 |
|
|
103 |
|
|
Deferred lease credit |
|
(6 |
) |
|
(6 |
) |
|
Stock-based compensation |
|
28 |
|
|
96 |
|
|
Foreign exchange loss |
|
(16 |
) |
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,077 |
) |
|
(2,173 |
) |
|
|
|
|
|
|
|
Changes in non-cash working capital |
|
50 |
|
|
37 |
|
|
|
|
|
|
|
|
Operating activities |
|
(2,027 |
) |
|
(2,136 |
) |
|
|
|
|
|
|
|
Financing activities |
|
- |
|
|
- |
|
|
|
|
|
|
|
|
Investing activities |
|
- |
|
|
(13 |
) |
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
16 |
|
|
(34 |
) |
|
|
|
|
|
|
|
Net decrease in cash from continuing operations |
|
(2,011 |
) |
|
(2,183 |
) |
|
|
|
|
|
|
|
Net increase in cash from discontinued operations |
|
- |
|
|
634 |
|
|
|
|
|
|
|
|
Cash beginning of the year |
|
4,493 |
|
|
4,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash end of the year |
|
2,482 |
|
|
3,313 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company's condensed unaudited interim consolidated financial
statements and management's discussion and analysis are being filed
under the Company's profile on SEDAR at www.sedar.com, as well as
on the Company's website at
www.helixbiopharma.com. Shareholders have the ability to
receive a hard copy of the Company's unaudited condensed interim
consolidated financial statements free of charge upon request at
the address below.
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 currently
listed on the TSX and FSE under the symbol "HBP".
Forward-Looking Statements and Risks and Uncertainties
This news release contains forward-looking statements and
information (collectively, "forward-looking statements") within the
meaning of applicable Canadian securities laws. Forward-looking
statements are statements and information that are not historical
facts but instead include financial projections and estimates;
statements regarding plans, goals, objectives, intentions and
expectations with respect to the Company's future business,
operations, research and development, including the Company's
activities relating to DOS47 and Topical Interferon Alpha-2b,
including the sourcing and qualifying of alternative raw material
samples, strengthening the BiPhasix™ patent portfolio and finding
suitable strategic partners and other information in future
periods.
Forward-looking statements include, without limitation,
statements concerning (i) the Company's ability to operate on a
going concern being dependent mainly on obtaining additional
financing; (ii) the Company's priority continuing to be L-DOS47;
(iii) the Company's development programs for Topical Interferon
Alpha-2b, DOS47 and L-DOS47; (iv) the Company's Polish Phase I/II
clinical trials for L-DOS47; (v) the Company's planned future U.S.
Phase I clinical trial for L-DOS47 and (vi) future expenditures,
insufficiency of the Company's current cash resources and the need
for financing and cost-cutting and/or cost-deferral measures and
future financing requirements and the seeking of additional
funding. Forward-looking statements can further be identified by
the use of forward-looking terminology such as "2013",
"2014", ongoing" or the negative thereof or any other
variations thereon or comparable terminology referring to future
events or results, or that events or conditions "will", "may",
"could", "would", or "should" occur or be achieved, or comparable
terminology referring to future events or results.
Forward-looking statements are statements about the future
and are inherently uncertain, and are necessarily based upon a
number of estimates and assumptions that are also uncertain.
Although the Company 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. Forward-looking statements, including
financial outlooks, are intended to provide information about
management's current plans and expectations regarding future
operations, including without limitation, future financing
requirements, and may not be appropriate for other purposes.
Certain material factors, estimates or assumptions have been
applied in making forward-looking statements in this news release,
including, but not limited to, the safety and efficacy of L-DOS47
and Topical Interferon Alpha-2b (low-grade cervical lesions); that
sufficient financing will be obtained in a timely manner to allow
the Company to continue operations; the timely provision of
services and supplies, including Interferon alpha-2b raw materials,
or other performance of contracts by third parties; future costs;
the absence of any material changes in business strategy or plans;
and the timely receipt of required regulatory approvals and
strategic partner support.
The Company's actual results could differ materially from
those anticipated in the forward-looking statements contained in
this news release as a result of numerous known and unknown risks
and uncertainties, including without limitation, the risk that the
Company's assumptions may prove to be incorrect; the risk that
additional financing may not be obtainable in a timely manner, or
at all, and that clinical trials may not commence or complete
within anticipated timelines or may fail; third party suppliers of
necessary services or of drug product and other materials may fail
to perform or be unwilling or unable to supply the Company, which
could cause delay or cancellation of the Company's research and
development or distribution activities; necessary regulatory
approvals may not be granted or may be withdrawn; the Company may
not be able to secure necessary strategic partner support; general
economic conditions, intellectual property and insurance risks;
changes in business strategy or plans; and other risks and
uncertainties referred to elsewhere in this news release, any of
which could cause actual results to vary materially from current
results or the Company's anticipated future results. Certain of
these risks and uncertainties, and others affecting the Company,
are more fully described in Helix's Annual Report, in particular
under the headings "Forward-looking Statements" and "Risk Factors",
and other reports filed under Helix's profile on SEDAR at
www.sedar.com from time to time. Forward-looking statements and
information are based on the beliefs, assumptions, opinions and
expectations of Helix's management on the date of this new release,
and Helix does not assume any obligation to update any
forward-looking statement or information should those beliefs,
assumptions, opinions or expectations, or other circumstances
change, except as required by law.
Investor Relations: Helix BioPharma Corp. Tel: 905 841-2300
Email: ir@helixbiopharma.com 3-305 Industrial Parkway South Aurora,
Ontario, Canada, L4G 6X7 Phone: (905) 841-2300 Fax: (905) 841-2244
Web: www.helixbiopharma.com
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