Helix BioPharma Corp. Announces Fiscal Q3 2014 Results
AURORA, ON--(Marketwired - Jun 12, 2014) - 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 and nine-month periods
ended April 30, 2014 and 2013.
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 ("LDOS002"). 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 Cohort 8
of the Phase I component of the European Phase I/II clinical study
by the summer of 2014. As previously disclosed, the total number of
patients to be enrolled in the study will depend on how many
escalating dose levels are required to reach maximum tolerated dose
("MTD"). The Company originally estimated that MTD would be reached
after enrolling eight cohorts of three patients. Management also
originally assumed that there would be two dose limiting toxicity
events requiring a further six patients to be enrolled, for a total
of up to 30 patients by the time the study dosed patients in Cohort
8.
On October 15, 2013, the Company announced the completion of an
interim data review of the first four cohorts for this study. The
release stated that L-DOS47 was well tolerated for all patients
treated within all cohorts. None of the treatment related adverse
events reported to date has met the definition of a dose-limiting
toxicity. Adverse events reported as of that date are those
normally expected for the population under study. The Company plans
to conduct a second interim data review of LDOS002 that will
commence following the completion of the second treatment cycle of
Cohort 8 patients. The Company has initiated a protocol amendment
that would allow sites to continue dose escalation for the Phase I
component of the LDOS002 study in the event MTD is not reached by
the end of Cohort 8. Without regulatory approval for the protocol
amendment, the Company will not be able to enroll patients beyond
Cohort 8.
The Company has met or exceeded certain expectations in
executing the clinical development plan for L-DOS47. Specifically,
the Company has:
- Completed the enrollment of Cohort 8 of the Phase I component
of study LDOS002 in advance of its previously disclosed
milestone.
- Applied for a new US Phase I Investigational New Drug ("IND")
trial and on April 22, 2014 announced the approval by the FDA to
commence a study for an L-DOS47 Phase I, open label, dose
escalation study in combination with standard doublet therapy of
pemetrexed/carboplatin in patients with Stage IV recurrent or
metastatic non-squamous non-small-cell lung cancer ("NSCLC").
Regarding the Clinical Trial Application ("CTA") filing in
Canada for the approval and commencement of a Phase I study for
L-DOS47 in combination with the chemotherapy drug vinorelbine in
patients with metastatic NSCLC and metastatic breast cancer, the
Company has had discussions with Health Canada. In these
discussions, Heath Canada requested additional information
regarding the proposed trial and in order to properly address
Health Canada's questions in the most efficient manner, the Company
on June 11, 2014 voluntarily withdrew the CTA submission and will
be resubmitting the CTA along with any additional information, as
soon as possible.
The Company's cash position as at April 30, 2014 of $2,832,000
is not sufficient to see the entire European Phase I/II clinical
study in Poland, nor any part of the U.S. Phase I study or, if
approved, the Canadian Phase I study, through to completion. The
Company has previously disclosed that it expected to have
sufficient cash to complete the Phase I portion of the European
clinical study, provided the Company did not experience any
unforeseen challenges and expenditures. The Company is currently
dosing patients in Cohort 8. The Company originally estimated that
the Phase I component of this study would enroll eight cohorts, as
this was the number of cohorts estimated to be required to reach
MTD. However, in the event the Company does receive regulatory
approval for the protocol amendment but does not reach MTD at
Cohort 8 as originally estimated, the Company will not have
sufficient funds to complete the European Phase I trial for L-DOS47
in Poland.
Topical Interferon Alpha-2b
After agreeing to terminate the contractual arrangement 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
$2,109,000 and $6,878,000, respectively for the three and
nine-month periods ended April 30, 2014 for a loss per common share
of $0.03 and $0.10, respectively. For the comparative three and
nine-month periods ended April 30, 2013, the Company recorded net
loss and total comprehensive loss of $2,224,000 (loss per common
share of $0.03) and net income and total comprehensive income of
$368,000 (earnings per common share of $0.01), respectively.
Included in net income and total comprehensive income for the
nine-month period ended April 30, 2013 is a gain on sale from
discontinued operations of $6,014,000. On January 25, 2013, the
Company announced the sale of its distribution business in
Canada.
Excluding both the gain on sale and net income and total
comprehensive income from discontinued operations, the Company
recorded a net loss and total comprehensive loss from continuing
operations of $2,224,000 and $6,281,000, respectively for the three
and nine-month periods ended April 30, 2013 for a loss per common
share of $0.03 and $0.09, respectively.
Research and development
Research and development costs totalled $1,285,000 and
$4,266,000, respectively for the three and nine-month periods ended
April 30, 2014. For the three and nine month periods ended April
30, 2013, research and development costs totalled $1,303,000 and
$3,960,000, respectively.
L-DOS47 research and development expenses for the three and
nine-month periods ended April 30, 2014 totaled $794,000 and
$1,999,000, respectively ($683,000 and $2,092,000 respectively for
the three and nine-month periods ended April 30, 2013). L-DOS47
research and development expenditures relate primarily to
expenditures associated with the ongoing European Phase I/II
clinical study in Poland, costs associated with the preparation of
the IND and CTA applications with the FDA and Health Canada,
respectively and ongoing overhead costs in support of the L-DOS47
drug program.
Topical Interferon Alpha-2b research and development expenses
for the three and nine-month periods ended April 30, 2014 totaled
$70,000 and $308,000, respectively ($87,000 and $599,000
respectively for the three and nine-month periods ended April 30,
2013). Beginning in June 2012, the Company initiated a downsizing
of the staff in the Saskatoon laboratory. The Company further
downsized staffing levels at its Saskatoon laboratory in October
2012, including a decision that resulted in the closure of the
Saskatoon laboratory at the end of November 2012. Costs associated
with the downsizing were charged in fiscal 2013. The Company has
now limited ongoing activities with respect to its Topical
Interferon Alpha-2b program 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 any remaining development costs.
Corporate research and development expenses for the three and
nine-month periods ended April 30, 2014 totaled $187,000 and
$1,213,000 respectively ($339,000 and $803,000 respectively for the
three and nine-month periods ended April 30, 2013). Included in
corporate research and development expenses for the nine-month
period ended April 30, 2014 is a one-time payout of $500,000
related to a severance payment.
Trademark and patent related expenses for the three and
nine-month periods ended April 30, 2014 totaled $142,000 and
$520,000, respectively ($94,000 and $118,000 respectively for the
three and nine-month periods ended April 30, 2013). The Company has
increased its efforts to strengthen the DOS47 and Biphasix™ patent
portfolio.
Operating, general and administration
Operating, general and administration expenses for the three and
nine-month periods ended April 30, 2014 totaled $829,000 and
$2,666,000, respectively ($911,000 and $2,379,000 respectively for
the three and nine-month periods ended April 30, 2013). Lower legal
fees, consulting fees, travel and investor relations activities
were the main drivers for lower operating, general and
administration expenses for the three-month period ended April 30,
2014 when compared to the three-month period ended April 30, 2013,
while on a year-to-date basis, these expenditures also reflect the
higher spend in operating, general and administrative expenses.
In addition, during the quarter, the Company completed the
wind-up and dissolution of Intercon Pharma Ltd., a wholly owned
subsidiary in Ireland, which was undertaken to simplify the
Company's corporate structure and repatriate cash.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash reserves of $2,832,000 as at April 30, 2014
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. 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 April 30, 2014 and July 31, 2013 are
summarized below:
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Financial Position
(thousand $) |
|
|
|
|
|
|
|
April 30 |
|
July 31 |
|
|
2014 |
|
2013 |
|
|
|
|
|
Non current assets |
|
525 |
|
677 |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Prepaid expenses |
|
123 |
|
139 |
|
Accounts receivable |
|
183 |
|
559 |
|
Cash |
|
2,832 |
|
4,493 |
|
|
3,138 |
|
5,191 |
Total assets |
|
3,663 |
|
5,868 |
Shareholders' equity |
|
3,013 |
|
4,920 |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Deferred lease credit |
|
4 |
|
23 |
|
Accrued liabilities |
|
400 |
|
621 |
|
Accounts payable |
|
246 |
|
304 |
|
|
650 |
|
948 |
Total liabilities & shareholders equity |
|
3,663 |
|
5,868 |
|
|
|
|
|
|
|
|
|
|
The Company's condensed unaudited interim consolidated statement
of net loss and comprehensive loss for the three and nine-month
periods ending April 30, 2014 and 2013 and the condensed unaudited
interim consolidated statement of cash flows for the three and
nine-month periods ending April 30, 2014 and 2013 are summarized
below:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Net Loss and
Comprehenisve Loss |
|
(thousand $, except for per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three-month periods ended |
|
|
For the nine-month periods ended |
|
|
|
|
|
Apr-30 |
|
|
Apr-30 |
|
|
Apr-30 |
|
|
Apr-30 |
|
|
|
2014 |
|
|
2013 |
|
|
2014 |
|
|
2013 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,285 |
|
|
|
1,303 |
|
|
|
4,266 |
|
|
|
3,960 |
|
|
Operating, general & administration |
|
|
829 |
|
|
|
911 |
|
|
|
2,666 |
|
|
|
2,379 |
|
|
(Gain) on disposal of property, plant, equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(18 |
) |
Results from operating activities before finance
items |
|
|
(2,114 |
) |
|
|
(2,214 |
) |
|
|
(6,932 |
) |
|
|
(6,321 |
) |
Finance items |
|
|
5 |
|
|
|
59 |
|
|
|
54 |
|
|
|
40 |
|
Loss and total comprehensive loss from continuing
operations |
|
|
(2,109 |
) |
|
|
(2,155 |
) |
|
|
(6,878 |
) |
|
|
(6,281 |
) |
Net income and total comprehensive income from
discontinued operations |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
635 |
|
Gain from sale of discontinued operation |
|
|
- |
|
|
|
(69 |
) |
|
|
- |
|
|
|
6,014 |
|
Net income (loss) and total comprehensive income
(loss) |
|
|
(2,109 |
) |
|
|
(2,224 |
) |
|
|
(6,878 |
) |
|
|
368 |
|
Loss per share from continuing operations * |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.09 |
) |
Income per share from discontinued operations
* |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
0.01 |
|
Total loss per common share * |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.10 |
) |
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Figures are for both basic and fully diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Cash Flows (thousand
$) |
|
(thousand $) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three-month periods ended |
|
|
For the nine-month periods ended |
|
|
|
|
|
Apr-30 |
|
|
Apr-30 |
|
|
Apr-30 |
|
|
Apr-30 |
|
|
|
2014 |
|
|
2013 |
|
|
2014 |
|
|
2013 |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and total comprehensive loss from continuing
operations |
|
(2,109 |
) |
|
(2,155 |
) |
|
(6,878 |
) |
|
(6,281 |
) |
Items not involving cash: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
51 |
|
|
104 |
|
|
155 |
|
|
310 |
|
|
Deferred lease credit |
|
(6 |
) |
|
(6 |
) |
|
(19 |
) |
|
(19 |
) |
|
Stock-based compensation |
|
118 |
|
|
68 |
|
|
299 |
|
|
240 |
|
|
Foreign exchange loss |
|
1 |
|
|
(51 |
) |
|
(34 |
) |
|
(24 |
) |
|
(Gain) on disposal of property, plant, equipment |
|
- |
|
|
- |
|
|
- |
|
|
(18 |
) |
|
|
(1,945 |
) |
|
(2,040 |
) |
|
(6,477 |
) |
|
(5,792 |
) |
Changes in non-cash working capital |
|
392 |
|
|
464 |
|
|
113 |
|
|
125 |
|
Operating activities |
|
(1,553 |
) |
|
(1,576 |
) |
|
(6,364 |
) |
|
(5,667 |
) |
Financing activities |
|
- |
|
|
- |
|
|
4,672 |
|
|
- |
|
Investing activities |
|
- |
|
|
(9 |
) |
|
(3 |
) |
|
(5 |
) |
Effect of exchange rate changes on cash |
|
(1 |
) |
|
51 |
|
|
34 |
|
|
24 |
|
Net decrease in cash from continuing operations |
|
(1,554 |
) |
|
(1,534 |
) |
|
(1,661 |
) |
|
(5,648 |
) |
Net increase in cash from discontinued operations |
|
- |
|
|
(270 |
) |
|
- |
|
|
7,460 |
|
Cash beginning of the year |
|
4,386 |
|
|
8,478 |
|
|
4,493 |
|
|
4,862 |
|
Cash end of the year |
|
2,832 |
|
|
6,674 |
|
|
2,832 |
|
|
6,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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 European Phase I/II
clinical trials for L-DOS47 in Poland including the number of
cohorts required to reach MTD and the Company's potential protocol
amendment in connection with this trial; (v) the Company's planned
future U.S. Phase I clinical trial for L-DOS47 and the Company's
CTA application in Canada; and (vi) future expenditures, the
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 "2014", "ongoing",
"estimates", "expects", 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 Company's ability to
commence the Phase I U.S. clinical trial for L-DOS47, the success
of the Company's CTA application and the cost and timeline for
reaching MTD in the Company's European Phase I/II clinical trial
for L-DOS47 in Poland and/or that the Company's proposed protocol
amendments for this study are accepted, in each case, on a timeline
and on terms satisfactory to the Company; 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 the anticipated budget 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 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 the Company'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 the Company 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
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