TORONTO, ONTARIO--(Marketwired - Dec. 13, 2016) - Helix BioPharma Corp. (TSX:HBP)(FRANKFURT:HBP), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, today announced its financial results for the quarter ended October 31, 2016.
HIGHLIGHTS
- Presented top-line data from its phase I/II dose escalation study of immunoconjugate L-DOS47 as a monotherapy in non-squamous non-small-cell lung cancer ("NSCLC") patients at the 17th International Association for the Study of Lung Cancer (IASCLC) world conference on lung cancer in Vienna, Austria;
- The U.S. Food and Drug Administration ("FDA") accepted an accelerated escalation scheme for L-DOS47 dosing in the U.S. phase I study ("LDOS001") up to 12 micrograms per kilogram in combination with pemetrexed/carboplatin;
- Announced the appointment of Theodore Witek Jr. to the Board of Directors of the Company;
- Presented a poster presentation entitled " CAR-T Cells Harboring Camelid Single Domain Antibody as Targeting Agent to CEACAM6 Antigen in Pancreatic Cancer" at the AACR Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts;
- Presented " Therapeutic Strategy Against Tumor Acidity Induced Immune-Suppression: L-DOS47 a Clinical Candidate for Lung Cancer" at the Precision Lung Cancer World R&D Summit in Boston, Massachusetts.
- Presented a corporate overview on the Company's development of its novel immuno-oncology drugs and product pipeline at the National Investment Banking Association at Newport Beach, California.
- Closed a private placement financing for gross proceeds of $1 million.
- Subsequent to the Company's fiscal first quarter ended October 31, 2016, the Company signed an exclusive agreement with Xisle Pharma Ventures ("Xisle") for its late stage Biphasix™ technology platform, including the lead product candidate, interferon alpha for the treatment of HPV-induced, low-grade cervical intraepithelial lesions. Xisle will be responsible for the continued clinical development and subsequent commercialization of the product. Under the terms of the agreement, Xisle pays an up-front fee of USD125,000 and subsequent milestone payments as they advance the technology to registration and market approvals.
FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of $3,287,000 and $2,592,000 (loss per common share of $0.04 and $0.03) for the three-month periods ended October 31, 2016 and 2015, respectively.
Research and development
Research and development expenses for the three-month periods ended October 31, 2016 and 2015 totalled $2,295,000 and $1,339,000, respectively. Higher research and development expenses relate primarily to expenditures associated with the ongoing European Phase I/II monotherapy clinical study in Poland, the Phase I combination clinical study in the U.S, the start-up and associated activities of the Company's newly established research laboratory in Warsaw, Poland, an increase in manufacturing costs and an increase in headcount.
Operating, general and administration
Operating, general and administration expenses for the three-month periods ended October 31, 2016 and 2015 totalled $1,008,000 and $1,259,000, respectively. The decrease mainly reflects a reduction in third-party consulting services and lower stock-based compensation expense.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash reserves of $2,397,000 as at October 31, 2016, 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. 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 October 31, 2016 and July 31, 2016 are summarized below.
| Consolidated Statement of Financial Position (thousand $) | |||||
| 31-Oct-16 | 31-Jul-16 | ||||
| Non current assets | 312 | 235 | |||
| Current assets: | |||||
| Prepaids | 54 | 90 | |||
| Accounts receivable | 485 | 489 | |||
| Cash | 2,397 | 3,654 | |||
| 2,936 | 4,233 | ||||
| Total assets | 3,248 | 4,468 | |||
| Shareholders' equity | 907 | 3,164 | |||
| Current liabilities: | |||||
| Accrued liabilities | 923 | 589 | |||
| Accounts payable | 1,418 | 715 | |||
| 2,341 | 1,304 | ||||
| Total liabilities & shareholders equity | 3,248 | 4,468 | |||
The Company's Consolidated Statements of Net Loss and Comprehensive Loss and Consolidated Statements of Cash Flow for the three-month periods ended October 31, 2016 and October 31, 2015 are summarized below:
| Consolidated Statements of Net Loss and Comprehensive Loss | |||||
| (thousand $, except for per share data) | |||||
| Oct-31 | Oct-31 | ||||
| 2016 | 2015 | ||||
| Other income | 27 | - | |||
| Expenses: | |||||
| Research and development | 2,295 | 1,339 | |||
| Operating, general & administration | 1,008 | 1,259 | |||
| Results from operating activities | |||||
| before finance items | (3,303 | ) | (2,598 | ) | |
| Finance items | (11 | ) | 6 | ||
| Net loss and total comprehensive loss | (3,287 | ) | (2,592 | ) | |
| Total loss per common share * | $ (0.04 | ) | $ (0.03 | ) | |
| * Figures are for both basic and fully diluted | |||||
| Consolidated Statements of Cash Flows (thousand $) | |||||
| Oct-31 | Oct-31 | ||||
| 2016 | 2015 | ||||
| Cash provided by (used in): | |||||
| Net loss and total comprehensive loss | (3,287 | ) | (2,592 | ) | |
| Items not involving cash: | |||||
| Depreciation of property, plant and equipment | 36 | 36 | |||
| Stock-based compensation | - | 73 | |||
| Foreign exchange loss | 9 | - | |||
| 45 | 109 | ||||
| Changes in non-cash working capital | 1,077 | 711 | |||
| Operating activities | (2,165 | ) | (1,772 | ) | |
| Financing activities | 1,030 | 16 | |||
| Investing activities | (113 | ) | (28 | ) | |
| Effect of exchange rate changes on cash | (9 | ) | - | ||
| Net decrease in cash from continuing operations | (1,257 | ) | (1,784 | ) | |
| Cash beginning of the period | 3,654 | 6,792 | |||
| Cash end of the period | 2,397 | 5,008 | |||
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 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".
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 and L-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.
