HBP:CC - Helix BioPharma Corp. Announces Fiscal 2023 First Quarter Results
(TheNewswire)
Toronto, Ontario – Thenewswire– December 14, 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 fiscal 2023first quarter results for the three-month period ending October 31,2022.
OVERVIEW
The Company reported a net loss and total comprehensive loss of$1,606,000 or $0.01 loss per common share for the three-month period ended October 31, 2022 (2021 - $1,813,000 or $0.01 loss per common share).
Clinicaldevelopment
LDOS47 in lung cancer
-
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.
-
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.
-
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 roadmap by the second quarter of2023.
LDOS47 in pancreatic cancer
The Company's Phase Ib/II combination trial inpancreatic cancer (LDSOS006) continues to recruit patients, as theCompany remains committed to this study. The second dosing cohort wassuccessfully completed in November 2022 without any safety concernsand enrolment into the third dosing cohort (9 µ g/kg) has now opened.
Corporatedevelopment
-
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.
-
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.
-
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.
-
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 $4,629,020 in subscription receipts related to this financingwith insiders subscribing for $270,000. On November 3, 2022, theCompany announced that it had closed a private placement financing fornet proceeds of CAD $4,629,020 from the issuance of 25,716,777 commonshares at a price of $0.18 per common share. The common shares issuedpursuant to the Private Placement are subject to a statutory holdperiod of four months and one day ending on March 4, 2023, inaccordance with applicable securities law. In connection with theclosing, the Company paid a cash fee of 10% of gross proceeds raisedto an eligible finder.
-
On October 3, 2022, the Company announced theappointment of Dr. Frank Gary Renshaw, as the Chief Medical Officer.
-
On December 8, 2022, the Company announced theappointment of Mr. Jacek Antas as the CEO of Helix replacing Mr. ArturGabor who had resigned as the CEO and as a director of the Company.Furthermore, Ms. Malgorzata Laube was appointed to the Board ofDirectors of the Company with immediate effect.
Research anddevelopment
Research & development expenses for the three-monthperiod ended October 31, 2022, totalled $1,300,000 (October 31,2021 – $1,249,000).
The following table outlines research and developmentcosts expensed for the following periods:
Research and development expenditures for thethree-month period ended October 31, 2022, when compared to thethree-month period ended October 31, 2021, were higher by $51,000. Theincrease in spending is mainly the result of higher expendituresassociated with research and development activities by 3% as well as a7% increase in business development cost. When compared to thethree-month period ended October 31, 2021, the Company also spent moreon salaries and benefits by $3,000 or 1%.
Operating, generaland administration
Operating, general and administrationexpenses for the three-month period endedOctober 31, 2022, totalled $ 285,000 (October 31, 2021 – $ 447,000).
The following table outlines operating, general andadministration expenses for the following periods:
Operating, general and administration expenditures for the three-month period ended October 31,2022, when compared to the three-month period ended October 31, 2021,were lower by $162,000 or 36%.
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.
Wages and benefits were decreased by $60,000 or 61%.This is due to the fact that the CFO position is now handled by theGrove Corporate Services contract which covers accounting,administration and corporate secretarial services. Directors fees andinvestor relations were decreased by $93,000 or 91% which is due tothe fact that the Company opted to restrict compensation to thedirectors to only stock-based compensation
LIQUIDITY AND CAPITALRESOURCES
The Company reported a net loss and total comprehensive loss for the three-month periods ended October31, 2022 of $1,606,000 (October 31, 2021- $1,813,000) . As at October 31, 2022 the Companyhad working capital deficiency of $903,000, shareholders’ equitydeficiency of $865,000 and a deficit of $196,72,000. 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. As of October 31, 2022, the Company has received atotal of $4,629,020 in subscription receipts related to this financingwith insiders subscribing for $270,000. On November 3, 2022, theCompany announced that it had closed a private placement financing fornet proceeds of CAD $4,629,020 from the issuance of 25,716,777 commonshares at a price of $0.18 per common share. The common shares issuedpursuant to the Private Placement are subject to a statutory holdperiod of four months and one day ending on March 4, 2023, inaccordance with applicable securities law. In connection with theclosing, the Company paid a cash fee of 10% of gross proceeds raisedto an eligible finder.
During the three-month period ended October 31, 2021,the Company completed two private placements resulting in the issuanceof 8,200,000 units (“Units”) at a price of $0.50 per Unit foraggregate gross proceeds of $4,100,000 ($3,561,000 net of issuecosts). The sale of the Units resulted in the issuance of anaggregate of 8,200,000 Common shares and 8,200,000 Warrants, with eachsuch Warrant entitling the holder thereof to purchase one Common Shareat an exercise price of $0.70 for a period of five years from the dateof issuance.
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 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 the three-month periods ended October 31, 2022and 2021 are summarized below:
The Company’s financialstatements, management’s discussion and analysis and annualinformation form will be filed under the Company’s profile on SEDARat 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”.
Company Contact
Helix BioPharma Corp.
401 Bay Street, suite 2704
Toronto, Ontario, M5H 2Y4
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 seekingof additional 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 interim management’s discussion andanalysis for the three-month period ended October 31, 2022 under theheading “Risks and Uncertainty” and Helix’s Annual InformationForm, in particular under the headings “Forward-lookingStatements” and “Risk Factors”, and other reports filed underthe Company’s profile on SEDAR at www.sedar.com from time to time.Forward-looking statements and information are based on the beliefs,assumptions, opinions and expectations of Helix’s management on thedate of this new release, and the Company does not assume anyobligation to update any forward-looking statement or informationshould those beliefs, assumptions, opinions or expectations, or othercircumstances change, except as required by law.
__________
Copyright (c) 2022 TheNewswire - All rights reserved.