Helix BioPharma Corp. Announces Fiscal 2018 Year-End Results

RICHMOND HILL, Ontario, Oct. 26, 2018 (GLOBE NEWSWIRE) — Helix BioPharma Corp. (TSX, FSE: “HBP”), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, today announced its financial results for the year ended July 31, 2018.

FINANCIAL REVIEW

The Company recorded a net loss and total comprehensive loss of $8,625,000 and $10,059,000 (a loss per common share of $0.09 and $0.11) for the fiscal years ended July 31, 2018 and 2017 respectively. 

Research and development

Research and development expenses totalled $6,084,000 and $6,524,000, respectively for the twelve-month periods ended July 31, 2018 and 2017.

The following table outlines research and development costs expensed and investment tax credits for the Company’s significant research and development projects for the fiscal years ended July 31:

    2018     2017  
L-DOS47 $ 4,893,000   $ 5,496,000  
V-DOS47   457,000     372,000  
CAR-T   318,000     259,000  
Corporate research and development expenses   432,000     474,000  
Trademark and patent related expenses   440,000     361,000  
Stock-based compensation expense   10,000     24,000  
Depreciation expense   141,000     103,000  
Research and development investment tax credit   (132,000 )   (230,000 )
Polish government grant subsidy (V-DOS47)   (475,000 )   (335,000 )
  $ 6,084,000   $ 6,524,000  
             

L-DOS47 research and development expenses for fiscal 2018 totalled $4,893,000 (2017 – $5,496,000).  L-DOS47 research and development expenditures relate primarily to the Company’s LDOS002 European Phase I/II clinical study in Poland, LDOS001 Phase I clinical study in the U.S., and preliminary expenditures related to the Company’s LDOS003 Phase II clinical study in Poland and the Ukraine.

The Company stopped further enrolment in the second stage of the Phase I/II component of the study due to lack of efficacy as defined by protocol.  The final analysis has been completed and the Company is currently awaiting the clinical study report.  In addition, given the limited cash resources, the LDOS003 clinical trial which was previously planned to commence enrolment in early 2018 had not moved forward though the Company is still committed to advance the program.  The Company continues to be committed to the LDOS001 study and has re-allocated resources to improve patient enrollment. An amendment to the LDOS001 study protocol allowed the Company to advance enrollment from Cohort two at the beginning of the 2018 fiscal year to where it was most recently announced that the Company commenced enrolment in the final two cohorts of the study which is now enrolling patients in Cohort six.  In addition, the Company has begun early development of a Phase I/II study, L-DOS47 given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. An initial draft study protocol was circulated in July 2018 and ongoing development continues.

V-DOS47 research and development expenses for fiscal 2018 totalled $457,000 (2017 – $372,000).  The higher expenditures in the current year mainly reflect the increase in staff and consultants as the Polish subsidiary ramped up activities in the program.  In fiscal 2016 the Company established a wholly-owned subsidiary in Poland and entered into a grant funding agreement with the Polish National Centre for Research and Development (“PNCRD”) for research and development expenditures associated with V-DOS47.  The Company’s subsidiary received $475,000 and $335,000 in fiscal 2018 and 2017, respectively, from the PNCRD.

CAR-T research and development expenses for fiscal 2018 and 2017 totalled $318,000 (2017 – $259,000).  During the current fiscal year, the Company announced a collaboration agreement related to novel CAR-T therapeutics and new antibody-based technologies for cell-based therapies.

Corporate research and development expenses were relatively flat for fiscal 2018 and 2017 and totalled $432,000 (2017 – $474,000).

Trademark and patent related expenses for fiscal 2018 and 2017 totalled $440,000 (2017 – $361,000).  The Company continues to ensure it works to adequately protect its intellectual property.

Operating, general and administration

Operating, general and administration expenses totalled $2,462,000 and $3,738,000, respectively for the fiscal years ended July 31, 2018 and 2016. The decrease in operating, general and administration expenses reflects the Company’s cost cutting initiatives.  The Company eliminated the employment/contractual arrangement with its then CEO, who was also a director of the Company, and also let go if it’s controller as part of a headcount reduction plan.  Aggressive steps were also taken to reduce unnecessary expenditures such as travel and conferences.  In addition, various third-party contracts were also eliminated. During the fiscal year the Company hired Deloitte as strategic advisor to explore partnering and licensing opportunities.  Cost reductions in Canada were offset by operating, general and administrative expenditure increases incurred at the Company’s Polish subsidiary.

LIQUIDITY AND CAPITAL RESOURCES

As at July 31, 2018 the Company had a working capital deficiency of $1,901,000 (2017 – $504,000), shareholders’ deficiency of $1,527,000 (2017 – $17,000) and a deficit of $164,005,000 (2017 – $155,380,000).

The Company’s cash reserves of $366,000, as at July 31, 2018 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 initiatives through to completion.  Subsequent to the Company’s fiscal year ending July 31, 2018, the Company closed two additional private placements for gross proceeds of $1,274,000.  Though the funds raised have assisted the Company in dealing with the working capital deficiency, additional funds are required to advance the various clinical and preclinical programs and pay for the Company’s overhead costs.  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.

The Company’s Consolidated Statement of Financial Position as at July 31, 2018 and July 31, 2017 is summarized below.

Consolidated Statement of Financial Position (thousand $)
    31-Jul-18   31-Jul-17  
       
Non current assets     374     487  
       
Current assets:      
Prepaids     92     173  
Accounts receivable     315     630  
Cash     366     897  
      773     1,700  
Total assets     1,147     2,187  
       
Shareholders’ deficiency     (1,527 )   (17 )
       
Current liabilities:      
Deferred government grant     38     44  
Accrued liabilities     644     722  
Accounts payable     1,992     1,438  
      2,674     2,204  
Total liabilities & shareholders deficiency   1,147     2,187  
         

The Company’s Consolidated Statement of Net Loss and Comprehensive Loss and Consolidated Statement of Cash Flow for fiscal 2018 and 2017 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 year ended           For the year ended  
    Jul-31     Jul-31             Jul-31   Jul-31    
    2018     2017             2018   2017    
                     
Expenses:             Cash provided by (used in):      
Research and development     6,084       6,524           Net loss and total comprehensive loss   (8,625 )   (10,059 )  
Operating, general, administration     2,462       3,738                  
Gain on sale property, plant, equipment     –        (168 )         Items not involving cash:      
              Depreciation   165     130    
Results from operating activities             Stock-based compensation   10     159    
before finance items     (8,546 )    (10,094 )         Foreign exchange loss (gain)   60     (33 )  
              Gain on sale property, plant, equipment   –      (168 )  
Finance items     (79 )     35               235     88    
                     
              Changes in non-cash working capital   866     676    
Loss and total comprehensive loss     (8,625 )    (10,059 )                
              Operating activities   (7,524 )   (9,295 )  
Loss per share -$   0.09   -$   0.11                  
* Figures are for both basic and fully diluted           Financing activities   7,105     6,719    
              Investing activities   (53 )   (214 )  
              Exchange rate changes on cash   (59 )   33    
              Net increase (decrease) in cash   (531 )   (2,757 )  
              Cash beginning of the period   897     3,654    
              Cash end of the period   366     897    
                     
                     

The Company’s consolidated financial statements, management’s discussion and analysis and annual information form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website at www.helixbiopharma.com.

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. Helix is currently listed on the TSX and FSE under the symbol “HBP”.

INVESTOR RELATIONS

Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9
Tel: (905) 841-2300
Email: 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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