HBP:CC - Helix BioPharma Corp. Announces Fiscal 2024 First Quarter Results
(TheNewswire)
Toronto, Ontario – TheNewswire– December 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 2024first quarter results for the period ending October 31, 2023.
OVERVIEW
The Company reported a net loss and total comprehensiveloss of $1,254,000 for the three months ended October 31, 2023,(October 31, 2022 - $1,606,000) and a loss of $0.01 per common share(July 31, 2023– loss of $0.01 per common share).
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Clinicaldevelopment
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On October 13,2023 the Companypresented new preclinical data on L-DOS47 in combination with PD1checkpoint inhibition at the 2023 AACR-NCI-EORTC InternationalConference on Molecular Targets and Cancer Therapeutics in Boston, viain person attendance. The title of the poster presentation was:Neutralizing Acidosis with ADC L-DOS47 Urease Immunoconjugate EnhancesResponse to Anti-PD1 Checkpoint Blockade in a Preclinical OrthotopicModel of Pancreatic Adenocarcinoma.
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On August 28, 2023, the Company together with itspartner Moffitt Cancer Center, Florida published data on BioRxivconfirming the effectiveness of L-DOS47 in combination with anti PD-1in pancreatic cancer. Statistically significant improvements in tumorregression were observed when combining L-DOS47 with anti-PD1 comparedto each compound alone.
LDOS47 in lung cancer
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 finalclinical trial report was further delayed amidst war in Ukraine whereall subjects were recruited. The company is now preparing to submitthe final clinical study report to regulatory authorities later thismonth.
LDOS47 in pancreatic cancer
The Company's Phase I-b/II combination trial inpancreatic cancer (LDSOS006) continues to recruit patients, now in thefourth dosing cohort (13.55 µg/kg), after successfully completing thesecond dosing cohort (9 µg/kg) in July 2023. We remain committed tothis study.
Another important aspect of the development of theLDOS47 platform is the combination with chemo- and/orimmuno-therapy to enhance current therapies, that may boost theutility of the platform. The Company continues to engage several key opinion leaders toevaluate potential combinations for partnership opportunities inother CEACAM6 expressing tumors.
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Corporatedevelopment
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On August 15, 2023, the Company announced that it hadclosed a private placement financing for net proceeds of CAD$2,998,000 from the issuance of 16,655,557 common shares at a price of$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 December 16, 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 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.
Research &development
Research & development expenses for the threemonths ended October 31, 2023, totalled $949,000 (2022 – $1,300,000 ).
The following table outlines research and developmentcosts expenses for the current and comparative periods (in thousandsof Canadian dollars):
Research and development expenditures for the threemonths ended October 31, 2023, when compared to the three months endedOctober 31, 2022, were lower by $351,000 or 27%. The decrease inspending is covered most areas of expenditures including thoseassociated with clinical and pre-clinical research and developmentactivities. Stock-based compensation expenses were similar whilesalaries and benefits were lower by $31,000 when compared to the threemonths ended October 31, 2022).
Operating, generaland administration
Operating, general and administrationexpenses for the three months ended October 31,2023, totalled $303,000 (2022 – $285,000 ).
The following table outlines operating, general andadministration expenses for the current and comparative periods (inthousands of Canadian dollars):
Operating, general and administration expenditures for the three months ended October 31, 2023,when compared to the three months ended October 31, 2022, were higherby $18,000 or 6%.
Since May 2022, the Company has made significantefforts to control and reduce its overheads expenditures. Thisincluded closing
its headquarters at Richmond Hill Ontario and moving itto Grove Corporate Services offices “(Grove”) in downtown Toronto.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 currentperiod.
In general, administrative savings were made inoperating expenses ($137,000), Wages were higher by ($12,000) andDirector and IR fees were higher by ($136,000). Stock-basedcompensation was higher by $18,000.
LIQUIDITY AND CAPITALRESOURCES
Since inception, the Company has mainly relied on financingits operations from public and private sales of equity. The Companydoes not have any credit facilities and is therefore not subject toany externally imposed capital requirements or covenants. The Company manages its liquidity risk by continuouslymonitoring forecasts and actual cash flow fromoperations and anticipated investment and financing activities.
The Company reported a net loss and total comprehensive loss of $1,254,000 for the three months ended October 31 ,2023, (2022 - $1,606,000) and a loss of $0.01 per common share (2022 -$0.01 per common share). As of October 31, 2022, the Company had aworking capital deficiency of $877,000, shareholders’ equitydeficiency of $844,000 and a deficit of $201,407,000.
On July 19, 2023, the Company applied to the TSX toprice protect a proposed $3 million financing of common shares at aprice of $0.18 per share. The TSX granted the conditional approval ofthe placement on July 19, 2023. On August 15, 2023, the Companyannounced that it had closed the private placement financing for grossproceeds of CAD $2,998,000 from the issuance of 16,655,557 commonshares at a price of $0.18 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. 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.
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 2025. The Company projects anaverage monthly fixed overhead spend of approximately $120,000. 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’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 three months ended October 31, 2023 under the heading“Risks and 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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