HBP Huttig Building Products Inc

Helix BioPharma Corp. (TSX: 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 third quarter ended April 30, 2019.

FINANCIAL REVIEW

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively.  For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share).

Research and development

Research and development costs for the three and nine-month periods ended April 30, 2019 totalled $1,351,000 and $3,695,000, respectively ($1,435,000 and $5,095,000 respectively for the three and nine-month periods ended April 30, 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 nine-month
	periods ended April 30						periods ended April 30
		2019			2018			2019			2018
L-DOS47	$	1,054,000		$	1,029,000		$	2,703,000		$	4,039,000
V-DOS47		137,000			133,000			369,000			310,000
CAR-T		–			192,000			333,000			317,000
Corporate research and development expenses		155,000			122,000			380,000			346,000
Trademark and patent related expenses		109,000			70,000			177,000			308,000
Stock-based compensation expense		–			2,000			–			8,000
Depreciation expense		26,000			31,000			85,000			111,000
Polish grant government funding		(130,000	)		(144,000	)		(352,000	)		(344,000	)
	$	1,351,000		$	1,435,000		$	3,695,000		$	5,095,000

L-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $1,054,000 and $2,703,000, respectively ($1,029,000 and $4,039,000 respectively for the three and nine-month periods ended April 30, 2018).  L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., and 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’s LDOS003 clinical study recently dosed its third patient and commenced second cohort enrollment.  The Company is very close to finalizing a clinical study protocol for a Phase I/II study with L-DOS47 to be 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 by the end of the month.

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 nine-month periods ended April 30, 2019 totalled $137,000 and $369,000, respectively ($133,000 and $310,000 respectively for the three and nine-month periods ended April 30, 2018).  For the three and nine-month periods ended April 30, 2019 the Company’s Polish subsidiary received grant funding of $130,000 and $352,000, respectively ($144,000 and $344,000 respectively for the three and nine-month periods ended April 30, 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 (“PNCRD”). The Agreement may be terminated by either party upon one month’s written notice and must also state the grounds for which the Agreement is being terminated.  In certain cases of termination, the Company’s Polish subsidiary may be obligated to return the received financial support in full within fourteen days of the day notice is served, with interest. As at April 30, 2019 that Company’s Polish subsidiary has received grant funds of approximately PLN3,634,609 or 28% of the entire grant funding amount approved by the PNCRD.

CAR-T research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $nil and $333,000 respectively ($192,000 and $317,000 respectively for the three and nine-month periods ended April 30, 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 nine-month periods ended April 30, 2019 totalled $109,000 and $177,000, respectively ($70,000 and $308,000 respectively for the three and nine-month periods ended April 30, 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 nine-month periods ended April 30, 2019 and 2018 totalled $699,000 and $1,605,000, respectively ($686,000 and $1,856,000 respectively for the three and nine-month periods ended April 30, 2018).  The decrease in operating, general and administration expenses mainly reflects the normalization of expenditures after companywide cost cutting initiatives.

The following table outlines operating, general and administration costs expensed for the following periods:

	For the three-month				For the nine-month
	periods ended April 30				periods ended April 30
	2019		2018		2019		2018
Wages and benefits	$	214,000	$	215,000	$	548,000	$	493,000
Director fees	42,000		13,000		122,000		148,000
Third-party advisors	361,000		320,000		675,000		779,000
Other general and administrative	78,000		133,000		250,000		420,000
Stock-based compensation expense	–		–		2,000		–
Depreciation expense	4,000		5,000		8,000		16,000
	$	699,000	$	686,000	$	1,605,000	$	1,856,000

LIQUIDITY AND CAPITAL RESOURCES

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively.  For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share), respectively.

As at April 30, 2019 the Company had a working capital deficiency of $2,203,000, shareholders’ deficiency of $1,920,000 and a deficit of $169,363,000.  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 $6,014,000 during the nine-month period ended April 30, 2019.  Subsequent to the April 30, 2019 quarter end, the Company announced the closing of a private placement on May 29th, 2019 for gross proceeds of $507,960.  Nevertheless, the Company’s cash reserves of $938,000 as at April 30, 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 nine-month periods ending April 30, 2019 and 2018 and the condensed unaudited interim consolidated statement of cash flows for the nine-month periods ending April 30, 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 $)
	For the nine-month periods ended							For the nine-month periods ended									For the nine-month periods ended
		Apr 30			Apr 30				Apr 30			Apr 30					Apr 30		Apr 30
		2019			2018				2019			2018					2019		2018
Expenses:																Cash provided by (used in):
Research and development		1,351			1,435				3,695			5,095				Net loss and total comprehensive loss	(5,358	)	(7,015	)
Operating, general, administration		699			686				1,605			1,856
Results from operating activities																Items not involving cash:
before finance items		(2,050	)		(2,121	)			(5,300	)		(6,951	)			Depreciation	93		116
																Stock-based compensation	2		8
Finance items		(21	)		(26	)			(58	)		(64	)			Foreign exchange loss	21		54
Loss and total comprehensive loss		(2,071	)		(2,147	)			(5,358	)		(7,015	)			Changes in non-cash working capital	874		1,284
Loss per share	-$	0.02		-$	0.02			-$	0.05		-$	0.07				Operating activities	(4,368	)	(5,553	)
* Figures are for both basic and fully diluted																Financing activities	4,963		5,517
																Investing activities	(2	)	(37	)
																Exchange rate changes on cash	(21	)	(54	)
																Net decrease in cash	572		(127	)
																Cash beginning of the period	366		897
																Cash end of the period	938		770

The Company’s Consolidated Statement of Financial Position as at April 30, 2019 and July 31, 2018 are summarized below.

Consolidated Statement of Financial Position (thousand $)
	30-Apr-19		31-Jul-18
Non current assets	283		374
Current assets:
Prepaids	220		92
Accounts receivable	158		315
Cash	938		366
	1,316		773
Total assets	1,599		1,147
Shareholders' deficiency	(1,920	)	(1,527	)
Current liabilities:
Deferred government grant	51		38
Accrued liabilities	667		644
Accounts payable	2,801		1,992
	3,519		2,674
Total liabilities & shareholders equity	1,599		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 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, 2018 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.