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or Name
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Helix BioPharma Corp
Symbol HBP
Shares Issued 75,900,337
Close 2014-10-23 C$ 1.79
Market Cap C$ 135,861,603
Recent Sedar Documents

Helix loses $8.68-million in fiscal 2014

2014-10-23 20:46 ET - News Release

An anonymous director reports

HELIX BIOPHARMA CORP. ANNOUNCES FISCAL 2014 RESULTS

Helix BioPharma Corp. has released its financial results for the year ended July 31, 2014.

Highlights

The following are selected highlights during the 2014 fiscal year and subsequent to year-end:

  • Completed a second interim review of data collected for the first eight cohorts in the company's continuing European phase I/II clinical study of L-DOS47 in Poland. The review included all available data, including patient demographics, safety assessments, pharmacokinetics, immunogenicity and radiological tumour assessments. The following observations were made:
    • Adverse events reported are those expected for the investigational product and population under study;
    • No dose-limiting toxicities reported;
    • Stable disease observed in radiological assessments of 12 of 24 (50 per cent) of patients treated;
    • Two patients completed six cycles of treatment.
  • Received approval from Polish regulatory authorities to continue dose escalation through cohorts nine to 12, based on the safety profile observed in the LDOS002 clinical study. By July 31, 2014, the company had completed enrolment for eight cohorts, and is currently enrolling into Cohort 10.
  • Received approval from the U.S. Food and Drug Administration to initiate an L-DOS47 phase I, open-label, dose-escalation study in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV recurrent or metastatic non-squamous NSCLC.
  • Announced the closing of two private placements for net proceeds totalling $10,153,000. The terms of the first private placement, which closed on Nov. 4, 2013, included the purchase of units at $1.15 per unit. Each unit consists of one common share and one warrant with an exercise price of $1.61 and an expiry of five years from the date of issue. On July 11, 2014, the company closed a second private placement, which included the purchase of units at $1.60 per unit. Each unit consists of one common share and one common share warrant with an exercise price of $2.24, and an expiry of five years from the date of issue.

Financial review

The company recorded a net loss and total comprehensive loss of $8,682,000 (12-cent loss per common share) and $1,545,000 (12-cent loss per common share) for the fiscal years ended 2014 and 2013, respectively.

Excluding the gain on sale and the net income and total comprehensive income from discontinued operations, the company realized a net loss and total comprehensive loss from continuing operations of $8,194,000 (12-cent loss per common share) for the fiscal year ended 2013. On Jan. 25, 2013, the company announced the sale of its distribution business in Canada.

Research and development

Research and development costs for fiscal 2014 and 2013 totalled $5,239,000 and $5,032,000, respectively.

L-DOS47 research and development expenses for fiscal 2014 and fiscal 2013 totalled $2.73-million and $2,771,000, respectively. L-DOS47 research and development expenditures relate primarily to expenditures associated with the continuing LDOS0002 clinical study in Poland and costs associated with the preparation of an investigational new drug and clinical trial applications with the FDA and Health Canada.

Topical interferon Alpha-2b research and development expenses for fiscal 2014 and fiscal 2013 totalled $383,000 and $774,000, respectively. In fiscal 2014, the company focused its continuing activities with respect to its topical interferon Alpha-2b program to sourcing and qualifying alternative interferon Alpha-2b raw material samples, strengthening the BiPhasix patent portfolio, and finding a suitable partner(s), which would be willing to license or acquire the product and support the remaining development costs.

Corporate research and development expenses for fiscal 2014 and fiscal 2013 totalled $1,407,000 and $1,081,000, respectively. Included in corporate research and development expense for fiscal 2014 is a one-time payment of $500,000 related to the termination of the company's former president and chief operating officer.

Trademark- and patent-related expenses for fiscal 2014 and fiscal 2013 totalled $612,000 and $278,000, respectively. The increase reflects additional efforts taken by the company to strengthen the DOS47 and Biphasix patent portfolio.

Operating, general and administration

Operating, general and administration expenses for the fiscal 2014 and 2013 totalled $3,496,000 and $3,196,000, respectively. Lower director and audit fees were offset by higher legal fees in defence of a legal claim, which management believes is without merit, higher stock-based compensation expense and higher consulting fees.

Liquidity and capital resources

The company's cash reserves of $6.98-million as at July 31, 2014, are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next 12 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 fiscal 2014 and 2013 financial statements are summarized in the attached table.

         CONSOLIDATED STATEMENTS OF NET LOSS AND COMPREHENISVE LOSS
                   (thousands $, except for per-share data)
                                                             2014       2013
Expenses
Research and development                                    5,239      5,032
Operating, general and administration                       3,496      3,196
Loss (gain) on disposal and impairment on property,
plant and equipment                                            --        (18)
Results from operating activities before finance items     (8,735)    (8,210)
Finance items                                                  53         16
(Loss) and total comprehensive (loss) from continuing
operations                                                 (8,682)    (8,194)
Net income and total comprehensive income from
discontinued operations                                        --        630
Gain from sale of discontinued operations                      --      6,019
Net (loss) and total comprehensive (loss)                  (8,682)    (1,545)
(Loss) per share from continuing operations*            $   (0.12) $   (0.12)
Income per share from discontinued operations*          $      --  $    0.01
Gain per share from sale of discontinued operations*    $      --  $    0.09
Total (loss) per common share*                          $   (0.12) $   (0.02)

* Figures are for both basic and fully diluted.

The company's complete 2014 consolidated financial statements, management's discussion and analysis, and annual information form are being filed today with Canadian securities regulatory authorities and will be available at SEDAR, as well as on the company's website. Shareholders have the ability to receive a hard copy of the company's complete audited financial statements free of charge upon request by e-mail or in writing to the company's chief financial officer at 305 Industrial Parkway South, Unit No. 3, Aurora, Ont., Canada, L4G 6X7.

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