Helix BioPharma Corp. Announces Fiscal Second Quarter 2019 Results

RICHMOND HILL, Ontario, March 18, 2019 (GLOBE NEWSWIRE) -- 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:

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:

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: