TORONTO, ONTARIO--(Marketwired - March 17, 2017) - 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 quarter ended January 31, 2017.
HIGHLIGHTS
- Announced management changes whereby Dr. Heman Chao, effective March 31, 2017 will take on the role of Chief Executive Officer replacing Dr. Sven Rohmann who will remain as Chairman of the Board and act as strategic adviser to Company. Dr. Heman Chao will remain Chief Scientific Officer in addition to his new role as CEO of the Company. In addition, Steve Demas has taken on the new role of Chief Operating Officer.
- Entered into a non-binding letter of intent with ProMab Biotechnologies Inc. to develop cell-based therapies;
- Completed a license agreement with the National Research Council of Canada ("NRC") for the worldwide right to anti-CEACAM6 antibody 2A3 for oncology applications;
- Signed an exclusive out-licence agreement with Xisle Pharma Ventures Trust for the company's late-stage, Biphasix technology platform;
- The Company's wholly-owned subsidiary, Helix Immuno-Oncology ("HIO"), signed a non-binding letter of intent with KEN Poland LLP for approximately $30.0 million in support of the proposed European Centre for Cancer Immunotherapy;
- At the Company's annual and special meeting of shareholders held on January 17, 2017, Messrs. George Anders, Albert G. Beraldo, Sylwester Cacek, Slawomir Majewski, Marek Orlowski, Sven Rohmann and Theodore J. Witek Jr. where elected as directors of the Company.
- On December 28 and 29, 2016 the Company closed two private placements for total gross proceeds of $1.8 million. On March 16, 2017, subsequent to the Company's fiscal quarter ending January 31, 2017, the Company closed another private placement for gross proceeds of $1,110,000. The terms for all the private placements are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share at an exercise price of $1.50 for a period of five years from the date of issuance.
FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of $2,618,000 and $5,905,000, respectively for the three and six-month periods ended January 31, 2017 for a loss per common share of $0.03 and $0.06, respectively. For the comparative three and six-month periods ended January 31, 2016, the Company recorded a net loss and total comprehensive loss of $2,226,000 and $4,818,000, respectively for a loss per common share of $0.03 and $0.06, respectively.
Research and development
Research and development costs totalled $1,911,000 and $4,179,000, respectively for the three and six-month periods ended January 31, 2017. For the three and six-month periods ended January 31, 2016, research and development costs totalled $1,246,000 and $2,585,000, respectively. Higher research and development expenditures for the three and six-month periods ended January 31, 2017 compared to the same periods for 2016 reflect the ongoing activity associated with the Company's ongoing European Phase I/II clinical study in Poland and costs associated with the Phase I clinical trial of LDOS001 in the U.S. In addition the Company also incurred costs associated with work performed in assessing the viability of an LDOS003 clinical study of L-DOS47 in combination with VIN/CIS in patients with metastatic or advances solid tumors and expenditures associated with V-DOS47, a new product under development in Poland which is partially government subsidized and is in the early stages of development. The Company has decided to substitute the vinorelbine/cisplatin combination study going forward with a study combining L-DOS47 with pemetrexed/carboplatin.
Operating, general and administration
Operating, general and administration expenses for the three and six-month periods ended January 31, 2017 totaled $873,000 and $1,181,000, respectively ($957,000 and $2,216,000 respectively for the three and six-month periods ended January 31, 2016). Lower operating, general and administration expenditures for the three and six-month periods ended January 31, 2017 compared to the same periods for 2016 is mainly the result of reduced stock-based compensation expense over the vesting period of options previously granted to non-management directors, and consulting services fees incurred in the previous comparative periods.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash balance of $1,423,000, as at January 31, 2017, is insufficient to meet anticipated cash needs for working capital and capital expenditures, nor is it sufficient to see the current research and development initiatives through to completion.
As at January 31, 2017 the Company had a working capital deficiency of $612,000 and a deficit of $151,226,000. As at July 31, 2016 the Company had working capital of $2,929,000 and a deficit of $145,321,000. The Company will require additional financing in the near term and in the future to see the current research and development initiates through to completion. There can be no assurance however, that additional financing can be obtained in a timely manner, or at all. Management therefore considers securing additional funds, expected to be through the issuance of equity securities of the Company, to be of the utmost importance.
The Company's Consolidated Statement of Financial Position as at January 31, 2017 and July 31, 2016 are summarized below.
| Consolidated Statement of Financial Position (thousand $) | ||||
| 31-Jan-17 | 31-Jul-16 | |||
| Non current assets | 428 | 235 | ||
| Current assets: | ||||
| Prepaids | 165 | 90 | ||
| Accounts receivable | 477 | 489 | ||
| Cash | 1,423 | 3,654 | ||
| 2,065 | 4,233 | |||
| Total assets | 2,493 | 4,468 | ||
| Shareholders' defieciency equity | (184 | ) | 3,164 | |
| Current liabilities: | ||||
| Accrued liabilities | 938 | 589 | ||
| Accounts payable | 1,739 | 715 | ||
| 2,677 | 1,304 | |||
| Total liabilities & shareholders equity | 2,493 | 4,468 | ||
The Company's condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and six-month periods ending January 31, 2017 and 2016 and the condensed unaudited interim consolidated statement of cash flows for the six-month periods ending January 31, 2017 and 2016 are summarized below:
| Consolidated Statements of Net Loss and Comprehensive Loss | ||||||||||||||
| (thousand $, except for per share data) | ||||||||||||||
| For the three-month | For the six-month | |||||||||||||
| periods ended | periods ended | |||||||||||||
| Jan-31 | Jan-31 | Jan-31 | Jan-31 | |||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||
| Expenses: | ||||||||||||||
| Research and development | 1,911 | 1,246 | 4,179 | 2,585 | ||||||||||
| Operating, general, administration | 873 | 957 | 1,881 | 2,216 | ||||||||||
| Gain on Sale of Capital Assets | (137 | ) | - | (137 | ) | - | ||||||||
| Results from operating activities | ||||||||||||||
| before finance items | (2,647 | ) | (2,203 | ) | (5,923 | ) | (4,801 | ) | ||||||
| Finance items | 29 | (23 | ) | 18 | (17 | ) | ||||||||
| Loss and total comprehensive loss | (2,618 | ) | (2,226 | ) | (5,905 | ) | (4,818 | ) | ||||||
| Loss per share | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.06 | ) | $ | (0.06 | ) | ||
| * Figures are for both basic and fully diluted | ||||||||||||||
| Consolidated Statements of Cash Flows | |||||
| (thousand $) | |||||
| For the six-month | |||||
| periods ended | |||||
| Jan-31 | Jan-31 | ||||
| 2017 | 2016 | ||||
| Cash provided by (used in): | |||||
| Net loss and total comprehensive loss | (5,905 | ) | (4,818 | ) | |
| Items not involving cash: | |||||
| Depreciation | 80 | 70 | |||
| Stock-based compensation | 15 | 138 | |||
| Gain from Sale of Capital Assets | (137 | ) | - | ||
| Grant non-cash recognition | (32 | ) | - | ||
| Foreign exchange loss | (18 | ) | 26 | ||
| (5,997 | ) | (4,584 | ) | ||
| Changes in non-cash working capital | 1,310 | 249 | |||
| Operating activities | (4,687 | ) | (4,335 | ) | |
| Financing activities | 2,542 | 120 | |||
| Investing activities | (104 | ) | (28 | ) | |
| Exchange rate changes on cash | 18 | (26 | ) | ||
| Net decrease in cash | (2,231 | ) | (4,269 | ) | |
| Cash beginning of the period | 3,654 | 6,792 | |||
| Cash end of the period | 1,423 | 2,523 | |||
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 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 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 and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker™. 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."
Cautionary Statements
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 and V-DOS47; (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 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.
