HBP:CC - Helix BioPharma Corp. Announces Fiscal 2023 Third Quarter Results
(TheNewswire)
Toronto, Ontario – TheNewswire – June 14, 2023 - 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 fiscal 2023third quarter results for the period ending April 30, 2023.
OVERVIEW
The Company reported a net loss and total comprehensiveloss of $1,337,000 and $4,136,000 for the three and nine-month periodsended April 30, 2023, respectively (April 30, 2022 - $1,345,000 and$5,177,000) and a loss of $0.01 and $0.01 per common sharerespectively (April 30, 2022– loss of $0.01 and $0.04 per commonshare).
Clinicaldevelopment
LDOS47 in lung cancer
Ø The Phase I study combination therapy in lungcancer (LDOS001) was completed and a manuscript was accepted forpublication in Journal ofThoracic Oncology Clinical and Research Reports on September 2 nd , 2022. The full-text open accessarticle can be found here: https://www.jtocrr.org/article/S2666-3643(22)00132-1/fulltext .
Ø 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. The company iscurrently working with study partners to retrieve any data that issalvageable and conclude the study by the end of the third quarter of2023.
Ø Another important aspect of the development ofthe LDOS47 platform is the combination with chemo- and/orimmuno-therapy to enhance current therapies, that may boost theutility of the platform. The Company continuesto have engaged several key opinion leaders to evaluate potentialcombinations for partnership opportunities.
LDOS47 in pancreatic cancer
The Company's Phase I-b/II combination trial inpancreatic cancer (LDSOS006) continues to recruit patients, now in thethird dosing cohort (9 µg/kg), after the successful completion of thesecond dosing cohort (6 µg/kg). A revision to the clinical studyprotocol was recently submitted to the U.S. Food and DrugAdministration to permit the addition of a further dosing cohort at13.55 µg/kg. We remain committed to this study.
Corporatedevelopment
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On November 3, 2022, the Company announced that it hadclosed a private placement financing for net proceeds of CAD$4,629,019.86 from the issuance of 25,716,777 common shares at a priceof $0.18 per common share. The common shares issued pursuant to theprivate placement were subject to a statutory hold period of fourmonths and one day ending on March 4, 2023, in accordance withapplicable securities law. In connection with the closing, the Companypaid a cash fee of 10% of gross proceeds raised to an eligible finder.
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On October 3, 2022, the Company announced theappointment of Dr. Frank Gary Renshaw, as the Chief Medical Officer.
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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 August 30, 2022, 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 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.
Research &development
Research & development expenses for the three andnine-month periods ended April 30, 2023, totalled $1,084,000 and$3,422,000 respectively (April 30, 2022 – $939,000 and$3,707,000).
The following table outlines research and developmentcosts expensed for the following periods:
Research and developmentexpenditures for the three -month period ended April 30, 2023, whencompared to the period ended April 30, 2022, were higher by$145,00 0 or 15%. However, the research anddevelopment expenditures for the nine -month period ended April 30,2023, when compared to the period ended April 30, 2022, were lower by$285,000. The decrease in spending is mainly the result of lowerexpenditures associated with research and development activities by 8%including 64% decrease in stock-based compensation expenses or$$167,000. When compared to the nine-month period ended April 30,2022, the Company spent more on salaries and benefits by 1%.
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. See “ Overview ” abovefor additional information.
Operating, generaland administration
Operating, general and administration expenses for thethree and nine-month periods ended April 30, 2023, totalled $272,000and 764,000 respectively (April 30, 2022 – totalled $363,000 and1,218,000).
The following table outlines operating, general andadministration expenses for the following periods:
Operating, general and administration expenditures forthe three and nine-month periods ended April 30, 2023, when comparedto the three and nine-month periods ended April 30, 2022, were lowerby $91,000 and $414,000 respectively or 25% and 37%.
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 currentyear.
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 and a decline in theprice of the Common Shares making it extremely challenging for theCompany to leverage the Multijurisdictional Disclosure System.
LIQUIDITY AND CAPITALRESOURCES
The Company reported a net loss and total comprehensiveloss of $1,337,000 and $4,136,000 for the three and nine-month periodsended April 30, 2023, respectively (April 30, 2022 - $1,345,000 and$5,177,000) and a loss of $0.01 and $0.02 per common sharerespectively (April 30, 2022 - loss of $0.01 and $0.04 per commonshare). As at April 30, 2023 the Company had working capital of$877,000, shareholders’ equity of $913,000 and a deficit of$199,254,000. As at July 31, 2022, the Company had working capital of$283,000, shareholders’ equity $319,000 and a deficit of$195,117,000.
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. On November 3, 2022, the Company announced that ithad closed a private placement financing for net proceeds of CAD$4,629,020 from the issuance of 25,716,777 common shares at a price of$0.18 per common share with insiders subscribing for $270,000. Thecommon shares issued pursuant to the Private Placement are subject toa statutory hold period of four months and one day ending on March 4,2023, in accordance with applicable securities law. In connection withthe closing, the Company paid a cash fee of 10% of gross proceedsraised to an eligible finder.
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 three-month period ended October 31, 2022,12,346,938 warrants were exercised for a total subscription amount of$3,210,204.
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.
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 $230,000. Thisamount does not include the costs related to any of the Company’sthird-party activities such as clinical studies, collaborativeresearch activities and contract manufacturing.
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The Company’s Statement of Financial Position andStatement of Net Loss and Comprehensive Loss for fiscal 2023 and 2022are summarized below:
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”.
Helix BioPharma Corp.
2704, 401 Bay Street,
Toronto M5H 2Y4, Ontario,
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) theCompany’s development programs for DOS47 and L-DOS47; (iv) futureexpenditures, the insufficiency of the Company’s current cashresources and the need for financing; (v) future financingrequirements, and the seeking of additional funding, and (vi)forecasts and future projections regarding development programs andexpenditures. Forward-looking statements can further be identified bythe use of forward-looking terminology such as “ongoing”,“estimates”, “expects”, or the negative thereof or any othervariations thereon or comparable terminology referring to futureevents or results, or that events or conditions “will”, “may”,“could”, or “should” occur or be achieved, or comparableterminology referring to future events or 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, 2023 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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