(via TheNewswire)
OVERVIEW
The Company reported a netloss and total comprehensive lossof
Clinical development
LDOS47 in lung cancer
The Phase I study combination therapy in lung cancer (LDOS001) was completed and the final clinical trial report issued in
December 2021 . A manuscript was accepted for publication inJournal of Thoracic Oncology Clinical and Research Reports onSeptember 2 nd, 2022. A pre-print can be found here: https://www.jtocrr.org/article/S2666-3643(22)00132-1/fulltext#relatedArticles.The Phase II study of combination therapy in lung cancer (LDOS003) was halted in the dose escalation portion of the study in 2020 at the height of pandemic lockdown and the final abbreviated clinical trial report has been further delayed amidst war in
Ukraine where all subjects were recruited. A final effort is being made in an attempt to retrieve any data that is salvageable and conclude the study.Another important aspect of the development of the LDOS47 platform is the combination with chemo- and/or immuno-therapy, that may boost the utility of the platform. The Company has engaged several key opinion leaders to evaluate the feasibility of such combinations and aims to develop a develop a roadmap by the second quarter of 2022.
LDOS47 in pancreatic cancer
The Company's Phase I-b/II combination trial in pancreatic cancer (LDSOS006) continues to recruit patients. We recently applied to the
Corporate development
On
August 19, 2021 , the Company announced that Dr.Krzysztof Saczek had been appointed as a member of the board of directors of the Company (the “Board”) effective immediately in connection with the resignation of Mr.Heman Chao as CEO, CSO and as a member of the Board. Mr. Chao’s resignation became effective onSeptember 1, 2021 andMr. Chao assumed the position of Chair of the Company’sScientific Advisory Board on the same date.
On
March 11, 2022 , the Company closed a private placement financing for gross proceeds of$1,001,000 from the issuance of 3,850,000 common share at a price of$0.26 per common share. OnApril 21, 2022 , the Company closed a private placement financing for net proceeds of$2,002,000 from the issuance of 7,700,000 common shares at a price of$0.26 per common share.
On
April 13, 2022 , the Company announced that it has received conditional approval from theToronto Stock Exchange to extend its previously announced Early Warrant Exercise Incentive Program fromApril 28, 2022 , toMay 31, 2022 . The Incentive Program is a period during which holders of the Company’s eligible common share purchase warrants (“Eligible Warrants”) may take advantage of a temporary reduction in the exercise price of the Eligible Warrants to a price ofC$0.26 . The Eligible Warrants include an aggregate of 49,806,469 warrants that if exercised at the Incentive Exercise Price will result in the Company receiving gross proceeds of up to$12,949,682 . During the year endedJuly 31, 2022 , 12,346,938 warrants were exercised for a total subscription amount of$3,210,204 .
On
April 18, 2022 , the Company announced thatArtur Gabor has been appointed as the Company’s Chief Executive Officer with immediate effect. The Company also announced the addition of three new members to its Board of Directors: Jerzy Leszczyński,Christopher Maciejewski andJacek Antas have been appointed to the Board effective immediately.
On
May 11, 2021 , the Company entered into a definitive convertible security funding agreement (the “Lind Agreement”) withLind Global Macro Fund, LP , aNew York based institutional investment fund managed byThe Lind Partners, LLC (collectively "Lind"). The Company closed the first tranche under the Lind Agreement onMay 13, 2021 for gross proceeds of$3,500,000 (the “First Tranche”).SeeLiquidity and Capital Resourcessection below.
On
May 18, 2022 , the Company announced the appointment of Mr.Hatem Kawar as the Company’s Chief Financial Officer effective immediately.
On
August 9, 2022 , the Company announced that it has entered into a two-year scientific collaboration agreement (“Agreement”) with University Hospital Tubingen (Germany ) to assess the therapeutic response of L-DOS47 in several cancer models expressing CEACAM6, with advanced preclinical metabolic imaging.
On
August 30, 2021 , the Company announced that it had completed the buyback of the outstanding amount of the convertible security funding agreement withLind Global Macro Fund, LP . The Company entered into the Agreement with Lind inMay 2021 and closed the first tranche under the Agreement for gross proceeds of$3,500,000 shortly thereafter. The Company has now bought back the amount outstanding of the Convertible Security under the Agreement, which isC$2,061,875 .
On
September 1, 2022 , the Company announced the appointment of Dr. Gabrielle M Siegers, MA, Ph.D., as the Head of RD based out of the Company’s lab inEdmonton .
On
Sep 12, 2022 , the Company applied to the TSX to price protect a proposed$5 million financing of common shares at a price of$0.18 per share. The TSX granted a price protection letter onSep 14, 2022 , and the conditional approval of the placement onSep 26, 2022 . The closing of the private placement is expected byNovember 1, 2022 . As ofOctober 31, 2022 , the Company has received a total of$4,644,000 in subscription receipts related to this financing.
On
October 3, 2022 , the Company announced the appointment of Dr.Frank Gary Renshaw , as the Chief Medical Officer.
Research and development
Research and development expenses for fiscal 2022 totalled
The following table outlines research and development costs and investment tax credits for the Company’s significant research and development projects for the fiscal years ended
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Research and development expenditures for the year ended
The Company hired biotechnology consultants to assess the Company’s drug product candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47.
Operating, general and administration
Operating, general and administration expenses for fiscal 2022 totalled
The following table outlines operating, general and administration costs expensedfor the fiscal years ended
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Operating, general and administrationexpenditures for the year ended
Since
Some expenditures in the comparative period relates to theCompany’s attempt to raise additional capital as part of a qualifying transaction to list its common shares on a
Several factors materialized that resulted in the Company abandoning its plans to list on a
LIQUIDITY AND CAPITAL RESOURCES
As at
On
On
On
On
In order for the Company to advance the currently planned preclinical and clinical research and development activities, its collaborative scientific research programs and pay for its overhead costs, the Company will need to raise approximately
The Company currently has three clinical studies (seeResearch and Development Activitiesabove for additional information) in various stages. The Company has completed the clinical study report for LDOS001 and submitted a final annual report to the FDA in
The Company received IND approval by the FDA to conduct a Phase I-b/II study (LDOS006) in the
The Company is also forecasting
The Company’sStatement of Financial Position andStatement of Net Loss and Comprehensive Loss for fiscal 2022 and 2021 are summarized below:
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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 atwww.sedar.com, as well as on the Company’s website atwww.helixbiopharma.com.
About
Investor Relations
Tel: 905-841-2300
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 focus of the Company’s primary drug product candidate L-DOS47 and other information relating to 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; (ii) the Company’s development programs, clinical studies, trials and reports for DOS-47 and 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; (v) future financing requirements, and the seeking of additional funding, and (vi) forecasts and future projections regarding development programs and expenditures. 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
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