HBP:CC - HELIX BIOPHARMA CORP. Announces Fiscal 2022 Year-End Results
(TheNewswire)
Toronto, Ontario – TheNewswire – November 1, 2022 - Helix BioPharma Corp. (TSX:HBP), (“ Helix ” or the “ Company ”), aclinical-stage biopharmaceutical company developing unique therapiesin the field of immuno-oncology based on its proprietary technologicalplatform DOS47, today announced financial results for the 2022 fiscalyear ended July 31, 2022.
OVERVIEW
The Company reported a net loss and total comprehensive loss of$6,563,000 or $0.04 loss per common share for fiscal 2022(2021 - $8,038,000 or $0.06 loss per common share).
Clinicaldevelopment
LDOS47 in lung cancer
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The Phase I study combination therapy in lung cancer(LDOS001) was completed and the final clinical trial report issued inDecember 2021. A manuscript was accepted for publication in Journal of Thoracic OncologyClinical and Research Reports on September2 nd ,2022. A pre-print can be found here:https://www.jtocrr.org/article/S2666-3643(22)00132-1/fulltext#relatedArticles.
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The Phase II study of combination therapy in lungcancer (LDOS003) was halted in the dose escalation portion of thestudy in 2020 at the height of pandemic lockdown and the finalabbreviated clinical trial report has been further delayed amidst warin Ukraine where all subjects were recruited. A final effort is beingmade in an attempt to retrieve any data that is salvageable andconclude the study.
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Another important aspect of the development of theLDOS47 platform is the combination with chemo- and/or immuno-therapy,that may boost the utility of the platform. The Company has engagedseveral key opinion leaders to evaluate the feasibility of suchcombinations and aims to develop a develop a roadmap by the secondquarter of 2022.
LDOS47 in pancreatic cancer
The Company's Phase I-b/II combination trial inpancreatic cancer (LDSOS006) continues to recruit patients. Werecently applied to the U.S. Food and Drug Administration for arevision to the clinical study protocol to extend the number oftreatment cycles for those patients where the benefits outweigh therisks. We remain committed to this study. The first dosing cohort wassuccessfully completed and now the second dosing cohort is alsonearing completion.
Corporatedevelopment
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On August 19, 2021, the Company announced that Dr.Krzysztof Saczek had been appointed as a member of the board ofdirectors of the Company (the “Board”) effective immediately inconnection with the resignation of Mr. Heman Chao as CEO, CSO and as amember of the Board. Mr. Chao’s resignation became effective onSeptember 1, 2021 and Mr. Chao assumed theposition of Chair of the Company’s Scientific Advisory Board on thesame date.
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On March 11, 2022, the Company closed a privateplacement financing for gross proceeds of $1,001,000 from the issuanceof 3,850,000 common share at a price of $0.26 per common share. OnApril 21, 2022 , the Company closed a privateplacement financing for net proceeds of $2,002,000 from the issuanceof 7,700,000 common shares at a price of $0.26 per commonshare.
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On April 13, 2022, the Company announced that it hasreceived conditional approval from the Toronto Stock Exchange toextend its previously announced Early Warrant Exercise IncentiveProgram from April 28, 2022, to May 31, 2022. The Incentive Program isa period during which holders of the Company’s eligible common sharepurchase warrants (“Eligible Warrants”) may take advantage of atemporary reduction in the exercise price of the Eligible Warrants toa price of C$0.26. The Eligible Warrants include an aggregate of49,806,469 warrants that if exercised at the Incentive Exercise Pricewill result in the Company receiving gross proceeds of up to$12,949,682. During the year ended July 31, 2022, 12,346,938 warrantswere exercised for a total subscription amount of $3,210,204.
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On April 18, 2022, the Company announced that Artur Gabor has beenappointed as the Company’s Chief Executive Officer with immediateeffect. The Company also announced the addition of three new membersto its Board of Directors: Jerzy Leszczy?ski, ChristopherMaciejewski and Jacek Antas have been appointed to the Board effectiveimmediately.
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On May 11, 2021, the Company entered into a definitiveconvertible security funding agreement (the “Lind Agreement”) withLind Global Macro Fund, LP, a New York based institutional investmentfund managed by The Lind Partners, LLC (collectively"Lind"). The Company closed the first tranche under the LindAgreement on May 13, 2021 for gross proceeds of $3,500,000 (the“First Tranche”). See Liquidity and CapitalResources section below.
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On May 18, 2022, the Company announced the appointmentof Mr. Hatem Kawar as the Company’s Chief Financial Officereffective immediately.
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On August 9, 2022, the Company announced that it hasentered into a two-year scientific collaboration agreement(“Agreement”) with University Hospital Tubingen (Germany) toassess the therapeutic response of L-DOS47 in several cancer modelsexpressing CEACAM6, with advanced preclinical metabolicimaging.
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On August 30, 2021, the Company announced that it hadcompleted the buyback of the outstanding amount of the convertiblesecurity funding agreement with Lind Global Macro Fund, LP. TheCompany entered into the Agreement with Lind in May 2021 and closedthe first tranche under the Agreement for gross proceeds of $3,500,000shortly thereafter. The Company has now bought back the amountoutstanding of the Convertible Security under the Agreement, which isC$2,061,875.
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On September 1, 2022, the Company announced theappointment of Dr. Gabrielle M Siegers, MA, Ph.D., as the Head of RDbased out of the Company’s lab in Edmonton.
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On Sep 12, 2022, the Company applied to the TSX toprice protect a proposed $5 million financing of common shares at aprice of $0.18 per share. The TSX granted a price protection letter onSep 14, 2022, and the conditional approval of the placement on Sep 26,2022. The closing of the private placement is expected by November 1,2022. As of October 31, 2022, the Company has received a total of$4,644,000 in subscription receipts related to thisfinancing.
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On October 3, 2022, the Company announced theappointment of Dr. Frank Gary Renshaw, as the Chief Medical Officer.
Research anddevelopment
Research and developmentexpenses for fiscal 2022 totalled $4,544,000 (2021 -$5,880,000).
The following table outlines research and developmentcosts and investment tax credits for the Company’s significantresearch and development projects for the fiscal years endedJuly 31:
Research and development expenditures for the yearended July 31, 2022, when compared to the year ended July 31, 2021,were lower by $1,318,000. The decrease in spending is mainly theresult of lower expenditures associated with research and developmentactivities by 29% partially offsetting the increases in consultingservices and stock-based compensation, which were higher due toexpense of stock options granted to consultants. When compared tothe year ended July 31, 2021, the Company also spent less on salariesand benefits by $195,000 or15% while consulting and stock-basedcompensation were higher by $943,000.
The Company hired biotechnology consultants to assessthe Company’s drug product candidate with a focus on identifyingvalue propositions and positioning strategies that would enableclinical adoption of L-DOS47.
Operating, generaland administration
Operating, general andadministration expenses for fiscal 2022 totalled $1,496,000 (2021 -$3,251,000).
The following table outlines operating, general andadministration costs expensed for the fiscalyears ended July 31:
Operating, general and administration expenditures for the year ended July 31, 2022, when comparedto the year ended July 31, 2021, were lower by $1,756,000 or54%.
Since May 2022. The Company has made significantefforts to control and reduce its overheads expenditures. Thisincluded closing its headquarters at Richmond Hill Ontario and movingit to Grove Corporate Services offices “(Grove”) in downtownToronto. The Company hired Grove to perform accounting and corporatesecretarial services following the resignation of its previous CFO inMay 2022. The savings apply to various activities including salaries,rent, legal, and other operational expenditures. Further measures arebeing taken which will result in more reductions in the nextquarter.
Some expenditures in the comparative period relates tothe Company’s attempt to raise additionalcapital as part of a qualifying transaction to list its common shareson a U.S. stock exchange, the termination of an investor relationsagreement with ACM Alpha Consulting Management EST (“ACMest”) andstock-based compensation expenses of stock options granted todirectors and consultants.
Several factors materialized that resulted in theCompany abandoning its plans to list on a U.S. stock exchange. Theseinclude but are not limited to the increase in the percentageownership of the Common Shares by new insiders;a decline in the price of the Common Shares making it extremelychallenging for the Company to leverage the MultijurisdictionalDisclosure System; and the resignation of the Company’s previousauditors.
LIQUIDITY AND CAPITALRESOURCES
As at July 31, 2022 the Company had working capital of$283,000 (2021 - $144,000), shareholders’ equity of $319,000 (2021– shareholders’ deficit of 1,393,000) and a deficit of $195,117,000 (2021 - $188,554,000).
On March 11, 2022, the Company closed a privateplacement financing for gross proceeds of $1,001,000 from the issuanceof 3,850,000 common share at a price of $0.26 per common share. OnApril 21, 2022, the Company closed a private placement financing fornet proceeds of $2,002,000 from the issuance of 7,700,000 commonshares at a price of $0.26 per common share.
On April 13, 2022, the Company announced that it hasreceived conditional approval from the Toronto Stock Exchange toextend its previously announced Early Warrant Exercise IncentiveProgram from April 28, 2022, to May 31, 2022. The Incentive Program isa period during which holders of the Company’s eligible common sharepurchase warrants (“Eligible Warrants”) may take advantage of atemporary reduction in the exercise price of the Eligible Warrants toa price of C$0.26. The Eligible Warrants include an aggregate of49,806,469 warrants that if exercised at the Incentive Exercise Pricewill result in the Company receiving gross proceeds of up to$12,949,682. During the year ended July 31, 2022, 12,346,938 warrantswere exercised for a total subscription amount of $3,210,204.
On August 30, 2022, the Company announced that it hadcompleted the buyback of the outstanding amount of the convertiblesecurity funding agreement with Lind at a cost of C$2,061,875. In May2021, the Company initially issued a convertible security with atwo-year term and a face value of $4,112,500 and issued an aggregateof 1,957,056 warrants exercisable into Common Shares for a period of48 months at an exercise price of $1.0283 per Common Share. As of July31, 2022, Lind has converted an aggregate of $1,233,750 of the facevalue of the Convertible Security issued under the first tranche intoan aggregate of 4,345,087 common of the Company at an average deemedprice of $0.243 per common share. In August 2022, Lind furtherconverted $405,625 of face value into an aggregate 2,507,329 shares atan average deemed price of $0.1618 per common share.
On September 12, 2022, the Company applied to the TSXto price protect a proposed $5 million financing of common shares at aprice of $0.18 per share. The TSX granted a price protection letter onSeptember 14, 2022, and the conditional approval of the placement onSeptember 26, 2022. As of October 31, 2022, the Company has received atotal of $4,644,000 in subscription receipts related to thisfinancing.
In order for the Company to advance the currentlyplanned preclinical and clinical research and development activities,its collaborative scientific research programs and pay for itsoverhead costs, the Company will need to raise approximately$11,000,000 through to the end of fiscal 2024. The Company projects anaverage monthly fixed overhead spend of approximately $250,000. Thisamount does not include the costs related to any of the Company’sthird-party activities such as clinical studies, collaborativeresearch activities and contract manufacturing.
The Company currently has three clinical studies (see Research and DevelopmentActivities above for additional information) invarious stages. The Company has completed the clinical study reportfor LDOS001 and submitted a final annual report to the FDA in April2022 and update the result into the www.clinicaltrials.gov portal in June 2022. The Company is forecastingapproximately $10,000 to finalize reporting.
The Company received IND approval by the FDA to conducta Phase I-b/II study (LDOS006) in the U.S., L-DOS47 in combinationwith doxorubicin, for previously treated advanced pancreatic cancer.Patient enrollment commenced December 2019. COVID-19 impacted patientenrollment resulting in the Company adding two additional clinicalsites this year. The Company is forecasting a cost of approximately$4,650,000 through to December 2024 to complete both the Phase I-b andPhase II portion of the trial. Certain conditions need to beachieved in order for the Company to be able to progress through tothe Phase II portion of the trial. Of the forecasted $4,650,000, theportion attributable to the Phase II is estimated to be approximately$2,600,000.
The Company is also forecasting $1,600,000 towardspre-clinical studies which are to be carried out in cooperation withits partners at Tubingen University and H. Lee Moffitt Cancer Centerand Research Institute Inc.
The Company’s Statement ofFinancial Position and Statement of Net Loss andComprehensive Loss for fiscal 2022 and 2021 are summarizedbelow:
The Company’s consolidatedfinancial statements, management’s discussion and analysis andannual information form will be filed under the Company’s profile onSEDAR at www.sedar.com , as well as on the Company’s website at www.helixbiopharma.com .
About Helix BioPharma Corp.
Helix BioPharma Corp. is a clinical-stagebiopharmaceutical company developing unique therapies in the field ofimmune-oncology for the prevention and treatment of cancer based onour proprietary technological platform DOS47. Helix is listed on theToronto Stock Exchange under the symbol “HBP”.
Investor Relations
Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9
Tel: 905-841-2300
Forward-LookingStatements and Risks and Uncertainties
Thisnews release contains forward-looking statements and information(collectively, “forward-looking statements”) within the meaning ofapplicable Canadian securities laws. Forward-looking statements arestatements and information that are not historical facts but insteadinclude financial projections and estimates, statements regardingplans, goals, objectives, intentions and expectations with respect tothe Company’s future business, operations, research and development,including the focus of the Company’s primary drug product candidateL-DOS47 and other information relating to future periods.
Forward-looking statements include,without limitation, statements concerning (i) the Company’sability to operate on a going concern being dependent mainly onobtaining additional financing; (ii) the Company’s prioritycontinuing 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 developmentprograms for DOS47 and L-DOS47; (iv) future expenditures, theinsufficiency of the Company’s current cash resources and the needfor financing; (v) future financing requirements, and the seeking ofadditional funding, and (vi) forecasts and future projectionsregarding development programs and expenditures. Forward-lookingstatements can further be identified by the use of forward-lookingterminology such as “ongoing”, “estimates”, “expects”, orthe negative thereof or any other variations thereon or comparableterminology referring to future events or results, or that events orconditions “will”, “may”, “could”, or “should” occuror be achieved, or comparable terminology referring to future eventsor results.
Forward-looking statements arestatements about the future and are inherently uncertain and arenecessarily based upon a number of estimates and assumptions that arealso uncertain. Although the Company believes that the expectationsreflected in such forward-looking statements are reasonable, suchstatements involve risks and uncertainties, and undue reliance shouldnot be placed on such statements. Forward-looking statements,including financial outlooks, are intended to provide informationabout management’s current plans and expectations regarding futureoperations, including without limitation, future financingrequirements, and may not be appropriate for other purposes. Certainmaterial factors, estimates or assumptions have been applied in makingforward-looking statements in this news release, including, but notlimited to, the safety and efficacy of L-DOS47; that sufficientfinancing will be obtained in a timely manner to allow the Company tocontinue operations and implement its clinical trials in the mannerand on the timelines anticipated; the timely provision of services andsupplies or other performance of contracts by third parties; futurecosts; the absence of any material changes in business strategy orplans; and the timely receipt of required regulatory approvals andstrategic partner support.
The Company’s actual results coulddiffer materially from those anticipated in the forward-lookingstatements contained in this news release as a result of numerousknown and unknown risks and uncertainties, including withoutlimitation, the risk that the Company’s assumptions may prove to beincorrect; the risk that additional financing may not be obtainable ina timely manner, or at all, and that clinical trials may not commenceor complete within anticipated timelines or the anticipated budget ormay fail; third party suppliers of necessary services or of drugproduct and other materials may fail to perform or be unwilling orunable to supply the Company, which could cause delay or cancellationof the Company’s research and development activities; necessaryregulatory approvals may not be granted or may be withdrawn; theCompany may not be able to secure necessary strategic partner support;general economic conditions, intellectual property and insurancerisks; changes in business strategy or plans; and other risks anduncertainties referred to elsewhere in this news release, any of whichcould cause actual results to vary materially from current results orthe Company’s anticipated future results. Certain of these risks anduncertainties, and others affecting the Company, are more fullydescribed in the Company’s annual management’s discussion andanalysis for the year ended July 31, 2022 under the heading “Risksand Uncertainty” and Helix’s Annual Information Form, inparticular under the headings “Forward-looking Statements” and“Risk Factors”, and other reports filed under the Company’sprofile on SEDAR at www.sedar.com from time to time. Forward-lookingstatements and information are based on the beliefs, assumptions,opinions and expectations of Helix’s management on the date of thisnew release, and the Company does not assume any obligation to updateany forward-looking statement or information should those beliefs,assumptions, opinions or expectations, or other circumstances change,except as required by law.
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