Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) (“Helix” or the
“Company”), a clinical stage immuno-oncology company developing
innovative drug candidates for the prevention and treatment of
cancer, announces its financial results for its fiscal second
quarter ended January 31, 2019.
FINANCIAL REVIEW
The Company recorded a net loss and total
comprehensive loss of $1,908,000 ($0.02 loss per common share) and
$2,564,000 ($0.03 loss per common share) for the three-month
periods ended January 31, 2019 and 2018, respectively. For
the six-month periods ended January 31, 2019 and 2018,
respectively, the Company recorded a net loss and total
comprehensive loss of $3,287,000 ($0.03 loss per common share) and
$4,868,000 ($0.05 loss per common share).
Research and development
Research and development costs for the three and
six-month periods ended January 31, 2019 totalled $1,330,000 and
$2,344,000, respectively ($1,895,000 and $3,660,000 respectively
for the three and six-month periods ended January 31, 2018).
The following table outlines research and
development costs expensed and investment tax credits for the
Company’s significant research and development projects for the
following periods:
|
|
For the three-month |
|
|
For the six-month |
|
|
|
periods ended January 31 |
|
|
periods ended January 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
L-DOS47 |
|
$ |
788,000 |
|
|
$ |
1,472,000 |
|
|
$ |
1,649,000 |
|
|
$ |
3,010,000 |
|
|
V-DOS47 |
|
102,000 |
|
|
94,000 |
|
|
232,000 |
|
|
177,000 |
|
|
CAR-T |
|
333,000 |
|
|
125,000 |
|
|
333,000 |
|
|
125,000 |
|
|
Corporate research and
development expenses |
|
125,000 |
|
|
125,000 |
|
|
225,000 |
|
|
224,000 |
|
|
Trademark and patent
related expenses |
|
43,000 |
|
|
139,000 |
|
|
68,000 |
|
|
238,000 |
|
|
Stock-based
compensation expense |
|
– |
|
|
2,000 |
|
|
– |
|
|
6,000 |
|
|
Depreciation
expense |
|
26,000 |
|
|
25,000 |
|
|
59,000 |
|
|
80,000 |
|
|
Polish
grant government funding |
|
(87,000 |
) |
|
(87,000 |
) |
|
(222,000 |
) |
|
(200,000 |
) |
|
|
$ |
1,330,000 |
|
|
$ |
1,895,000 |
|
|
$ |
2,344,000 |
|
|
$ |
3,660,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
L-DOS47 research and development expenses for
the three and six-month periods ended January 31, 2019 totalled
$788,000 and $1,649,000, respectively ($1,472,000 and $3,010,000
respectively for the three and six-month periods ended January 31,
2018). L-DOS47 research and development expenditures relate
primarily to the Company’s LDOS001 Phase I clinical study in the
U.S., and preliminary expenditures related to the Company’s LDOS003
Phase II clinical study in Poland, Ukraine and Hungary.
The Company’s LDOS001 clinical study continues
to face patient enrolment challenges. An accelerated dosing
protocol has been approved to help accelerate the LDOS001 clinical
study. The Company continues to be committed to the LDOS001 study
and has re-allocated limited resources to improve patient
enrollment. Enrolment in the Company’s LDOS002 clinical study
was previously halted at the end of stage 1 of a two-stage phase II
study as the intensified schedule did not result in improving
patient benefits compared to that observed in the Phase I portion
of the study. The Company recently advanced some funds to the CRO
overseeing the LDOS003 study and most recently announced the dosing
of the first patient. The Company is in the late stages of
protocol development for a Phase I/II study with L-DOS47 given in
combination with doxorubicin, for the treatment of metastatic
pancreatic cancer. The Company expects to file an
investigational new drug application with the U.S. Food and Drug
Administration for a study protocol targeting advanced pancreatic
cancer patients sometime in April/May 2019.
The Company’s Polish subsidiary continues to
focus its activities on the V-DOS47 pre-clinical program.
V-DOS47 research and development expenses for the three and
six-month periods ended January 31, 2019 totalled $102,000 and
$232,000, respectively ($94,000 and $177,000 respectively for the
three and six-month periods ended January 31, 2018). For the
three and six-month periods ended January 31, 2019 the Company’s
Polish subsidiary received grant funding of $87,000 and $222,000,
respectively ($87,000 and $200,000 respectively for the three and
six-month periods ended January 31, 2018). Grant funding for
the V-DOS4 program is the result of an agreement entered into with
the Polish National Centre for Research and Development.
CAR-T research and development expenses for the
three and six-month periods ended January 31, 2019 totalled
$333,000 and $333,000 respectively ($125,000 and $125,000
respectively for the three and six-month periods ended January 31,
2018). The Company commenced development of novel CAR-T
therapeutics and new antibody-based technologies for cell-based
therapies. The Company’s CAR-T expenditures relate primarily to
collaborative research activities with ProMab Biotechnologies
Inc.
Trademark and patent related expenses for the
three and six-month periods ended January 31, 2019 totalled $43,000
and $68,000, respectively ($139,000 and $238,000 respectively for
the three and six-month periods ended January 31, 2019). The
Company continues to ensure it adequately protects its intellectual
property.
Operating, general and
administration
Operating, general and administration expenses
for the three and six-month periods ended January 31, 2019 and 2018
totalled $533,000 and $906,000, respectively ($644,000 and
$1,170,000 respectively for the three and six-month periods ended
January 31, 2018). The decrease in operating, general and
administration expenses mainly reflects companywide cost cutting
initiatives.
The following table outlines operating, general
and administration costs expensed for the following periods:
|
|
For the three-month |
|
For the six-month |
|
|
periods ended April 30 |
|
periods ended April 30 |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Wages and benefits |
|
$ |
179,000 |
|
$ |
151,000 |
|
$ |
334,000 |
|
$ |
278,000 |
|
Director fees |
|
41,000 |
|
55,000 |
|
80,000 |
|
135,000 |
|
Third-party
advisors |
|
210,000 |
|
309,000 |
|
314,000 |
|
459,000 |
|
Other general and
administrative |
|
100,000 |
|
124,000 |
|
172,000 |
|
287,000 |
|
Stock-based
compensation expense |
|
– |
|
– |
|
1,000 |
|
– |
|
Depreciation expense |
|
3,000 |
|
5,000 |
|
5,000 |
|
11,000 |
|
|
$ |
533,000 |
|
$ |
644,000 |
|
$ |
906,000 |
|
$ |
1,170,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIQUIDITY AND CAPITAL
RESOURCES
The Company recorded a net loss and total
comprehensive loss of $1,908,000 ($0.02 loss per common share) and
$2,564,000 ($0.03 loss per common share) for the three-month
periods ended January 31, 2019 and 2018, respectively. For
the six-month periods ended January 31, 2019 and 2018,
respectively, the Company recorded a net loss and total
comprehensive loss of $3,287,000 ($0.03 loss per common share) and
$4,868,000 ($0.05 loss per common share), respectively.
As at January 31, 2019 the Company had a working
capital deficiency of $1,998,000, shareholders’ deficiency of
$1,686,000 and a deficit of $167,292,000. As at July 31, 2018
the Company had a working capital deficiency of $1,901,000,
shareholders’ deficiency of $1,527,000 and a deficit of
$164,005,000.
The Company continues to work with vendors to
manage its cash position while ensuring vendors continue providing
services while being paid, albeit over a longer period of time than
previously agreed terms. Some vendors have placed the Company
on hold (cash in advance) and is impacting the Company’s clinical
development program. The Company has raised gross proceeds of
approximately $8,518,000 from private placement financings during
fiscal 2018 and an additional $3,878,400 during the six-month
period ended January 31, 2019. In addition, the Company
subsequent to the January 31, 2019 quarter end, announced the
closing of a private placement on March 15, 2019 for gross proceeds
of $609,450. Nevertheless, the Company’s cash reserves of
$306,000 as at January 31, 2019 continue to be 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 or any planned research and development initiatives through
to completion. Though the funds raised have somewhat assisted
the Company in dealing with its working capital deficiency and
attempts to make vendors current, additional funds are required to
advance the various clinical and preclinical programs, pay for the
Company’s overhead costs and its past due vendors. 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 critical for its development
needs.
Additional information can be found about the
Company’s liquidity and capital resources in the Company’s
Management Discussion and Analysis.
The Company’s condensed unaudited interim
consolidated statement of net loss and comprehensive loss for the
three and six-month periods ending January 31, 2019 and 2018 and
the condensed unaudited interim consolidated statement of cash
flows for the six-month periods ending January 31, 2019 and 2018
are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Net Loss and Comprehensive
Loss |
|
|
|
Consolidated Statements of Cash Flows |
|
|
|
(thousand $, except for per share data) |
|
|
|
|
|
|
(thousand $) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three-month periods ended |
|
For the six-month periods ended |
|
|
|
|
For the six-month periods ended |
|
|
|
|
|
|
|
|
|
|
|
Jan 31 |
Jan 31 |
|
Jan 31 |
Jan 31 |
|
|
|
|
Jan 31 |
Jan 31 |
|
|
|
2019 |
2018 |
|
2019 |
2018 |
|
|
|
|
2019 |
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Cash provided by (used in): |
|
|
|
|
Research and development |
|
|
1,330 |
|
|
1,895 |
|
|
|
2,344 |
|
|
3,660 |
|
|
|
Net loss and total comprehensive loss |
|
(3,287 |
) |
(4,868 |
) |
|
Operating, general, administration |
|
|
533 |
|
|
644 |
|
|
|
906 |
|
|
1,170 |
|
|
|
|
|
|
|
|
Results from operating activities |
|
|
|
|
|
|
|
|
Items not involving cash: |
|
|
|
|
before finance items |
|
|
(1,863 |
) |
|
(2,539 |
) |
|
|
(3,250 |
) |
|
(4,830 |
) |
|
|
Depreciation |
|
64 |
|
91 |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
2 |
|
6 |
|
|
Finance items |
|
|
(45 |
) |
|
(25 |
) |
|
|
(37 |
) |
|
(38 |
) |
|
|
Foreign exchange loss |
|
13 |
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss and total comprehensive loss |
|
|
(1,908 |
) |
|
(2,564 |
) |
|
|
(3,287 |
) |
|
(4,868 |
) |
|
|
Changes in non-cash working capital |
|
37 |
|
503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share |
|
$ |
(0.02 |
) |
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
$ |
(0.05 |
) |
|
|
Operating activities |
|
(3,171 |
) |
(4,233 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Figures are for both basic and fully diluted |
|
|
|
|
|
|
Financing activities |
|
3,126 |
|
5,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
(2 |
) |
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange rate changes on cash |
|
(13 |
) |
(35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash |
|
(60 |
) |
744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash beginning of the period |
|
366 |
|
897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash end of the period |
|
306 |
|
1,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company’s Consolidated Statement of
Financial Position as at January 31, 2019 and July 31, 2018 are
summarized below.
|
|
|
|
|
Consolidated Statement of Financial Position (thousand
$) |
|
|
|
|
|
|
|
|
31-Jan-19 |
|
31-Jul-18 |
|
|
|
|
|
|
|
Non current assets |
|
312 |
|
374 |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
Prepaids |
|
331 |
|
92 |
|
|
Accounts receivable |
|
246 |
|
315 |
|
|
Cash |
|
306 |
|
366 |
|
|
|
|
883 |
|
773 |
|
|
|
|
|
|
|
Total assets |
|
1,195 |
|
1,147 |
|
|
|
|
|
|
|
Shareholders' deficiency |
|
(1,686 |
) |
(1,527 |
) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
Deferred government grant |
57 |
|
38 |
|
|
Accrued liabilities |
|
446 |
|
644 |
|
|
Accounts payable |
|
2,378 |
|
1,992 |
|
|
|
|
2,881 |
|
2,674 |
|
|
|
|
|
|
|
Total liabilities & shareholders equity |
1,195 |
|
1,147 |
|
|
|
|
|
|
|
|
|
|
|
|
The Company’s condensed unaudited interim
consolidated financial statements and management’s discussion and
analysis will be filed under the Company’s profile on SEDAR at
www.sedar.com, as well as on the Company’s website.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology
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 Chimeric Antigen Receptor (“CAR”) based cell
therapies. Helix is currently listed on the TSX and FSE under the
symbol “HBP”.
INVESTOR RELATIONS
Helix BioPharma Corp.9120 Leslie Street, Suite
205Richmond Hill, Ontario, L4B 3J9Tel: (905) 841-2300Email:
ir@helixbiopharma.com
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 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 DOS47,
L-DOS47, V-DOS47 and CAR-T; (iv) future expenditures, the
insufficiency of the Company’s current cash resources and the need
for financing; and (v) 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 “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”, 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;
that sufficient financing will be obtained in a timely manner to
allow the Company to continue operations and implement its clinical
trials in the manner and on the timelines anticipated; the timely
provision of services and supplies 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 the Company’s annual management’s discussion and
analysis for the year ended July 31, 2017 under the heading “Risks
and Uncertainty” and Helix’s Annual Information Form, 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.
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