Helix BioPharma Corp. Announces Fiscal 2025 Year-End Results
(TheNewswire)
Toronto, Ontario – TheNewswire - 29 October 2025 –Helix BioPharma Corp. (TSX:“HBP”, OTC: “HBPCF”, FRANKFURT: “HBP0”) ( “Helix” or the “Company” ), aclinical-stage oncology company shaping a near future where today’shard-to-treat cancers are vincible, today announced financial resultsfor the 2025 fiscal year ended July 31, 2025.
Overview
The Company reported a net loss and total comprehensiveloss of $5,205,000 for the year ended July 31, 2025, (July 31, 2024:$9,264,000) and a loss of $0.09 per common share (July 31, 2024: lossof $0.21 per common share.
Clinical Development
In the second half of 2024, the Company conducted anextensive review of its assets and forward strategy, that resulted inthe following key decisions:
The Company decided to focus its resources ondeveloping L-DOS47 as a combination therapy with PD-1 inhibitor,pembrolizumab, as first-line therapy for Non-Small Cell Lung Carcinoma(NSCLC). This decision was the result of an extensive expert review ofavailable pre-clinical and clinical data on L-DOS47, the significantunmet medical need in NSCLC despite the emergence of immunotherapy asthe standard of care, and an assessment of where a pharmacologicaltumor alkalization therapy is most likely to deliver meaningfulclinical impact in the near term, also keeping in mind the shortesttime to FDA approval.
On August 9, 2024 and August 13, 2024, the researchcollaborations with University of Tuebingen, Germany, and Peter Mac,Australia, respectively, were terminated. Projects with theseinstitutions were outside the scope of the new focus on NSCLC.
The Company resolved to close its laboratory inEdmonton Canada, which was closed on 31 October, 2024, withliquidation of laboratory equipment and safekeeping of documents,reagents, and lab samples with a third-party storage provider.
The Company’s Phase Ib/II combination trial inmetastatic pancreatic adenocarcinoma (LDOS006) evaluating the safetyand tolerability of L-DOS47 in combination with doxorubicin wascompleted in October 2024. Data and sample analyses are ongoing withthe Clinical Study Report (CSR) expected to be issued fall2025.
LDOS007 is a new Phase Ib/Randomized Phase II, openlabel study to assess L-DOS47 in combination with pembrolizumab asfirst-line therapy in NSCLC, currently in the planning stage. TheCompany received positive and constructive feedback in writing fromthe U.S. Food and Drug Administration (FDA) on the study design ofLDOS007 on August 8, 2025, ahead of a planned End-of-Phase I (EOP1)meeting that was scheduled with the FDA via videoconference on August13, 2025. As the FDA indicated that the Company could proceed withoutthe meeting if the written feedback was sufficiently clear, and giventhat no additional discussion was deemed necessary, the Companyelected to forego the videoconference in favor of preparing theClinical Trial Application (CTA) as the next step in its interactionswith the Agency. The study design will include an initial doseescalation safety lead-in investigating low, medium and high L-DOS47dose levels in combination with standardpembrolizumab, followed by a randomized Phase II arm to test twoselected L-DOS47 dose levels in combination versus standardpembrolizumab alone.
Corporate Development
On September 5, 2025, the Company announced it will notproceed with the previously announced equity draw-down subscriptionfacility with GEM Global Yield LLC SCS and GEM Yield Bahamas Limited(together, “GEM”), given that the Company determined that the GEMfacility no longer aligns with its capital strategy or its commitmentto maximizing long-term shareholder value.
On August 22, 2025, the Company closed its non-brokeredprivate placement of 2,222,333 common shares of the Company at a priceof $0.75 per Common Share for gross proceeds of $1,667,000.
On August 13, 2025, the Company announced thepublication of a peer-reviewed article by Frontiers in Oncologyreporting results from a previously completed Phase I/II clinicalstudy of L-DOS47 as a single agent in patients with advanced non-smallcell lung cancer (NSCLC) and titled “Safety of unconventionalantibody-drug conjugate L-DOS47 in a Phase I/II monotherapy studytargeting advanced NSCLC”.
On June 16, 2025, the Company completed filing of theCompany’s interim financial statements for the nine months endedApril 30, 2025 (the “Financial Statements”), the management’sdiscussion and analysis relating to the Financial Statements, and theCEO and CFO certifications relating to the Financial Statements(collectively, the “Interim Filings”).
On June 2, 2025, the Company announced appointment ofRohit Babbar as Chief Financial Officer (“CFO”) of the Company,replacing James B. Murphy. Mr. Babbar is further supported by anexperienced team specializing in accounting and finance, capitalraising and administrative operations via Brio Financial Group, aUS-based financial and management consulting firm, of which Mr. Babbaris a Director.
On May 20, 2025, the Company closed the Laevoroc assetacquisition transactions, acquiring substantially all of the assetsand certain liabilities of Laevoroc Immunology AG and LaevorocChemotherapy AG, in consideration for the issuance of 11,555,076common shares at a fair value of $9,880,000 and 9,454,153 commonshares at a fair value of $8,083,000, respectively.
On April 24, 2025, the Company announced appointment ofVeronika Kandziora as Chief Operating Officer (“COO”).
On April 21, 2025, the Company issued 125,000 commonshares for the exercise of 125,000 stock options for cash proceeds of$113,000.
On April 10, 2025, the Company announced appointment ofThomas Mehrling, MD, PhD as Chief Executive Officer (“CEO”),taking over from Jacek Antas, who continues to be a Director and theChairman of the Board.
On March 26, 2025, the Company announced the votingresults from the Annual and Special Meeting of its Shareholders(“the Meeting”), which was held on the same day. A total of40,294,667 common shares were voted at the Meeting, representing 76%of the Company’s total issued and outstanding shares, with all itemsof business approved by an overwhelming majority of the sharesrepresented (99.5%).
On March 18, 2025, the Company completed filing of theCompany’s interim financial statements for the three and six monthsended January 31, 2025 (the “Financial Statements”), themanagement’s discussion and analysis relating to the FinancialStatements, and the CEO and CFO certifications relating to theFinancial Statements (collectively, the “InterimFilings”).
On January 8, 2025, the Company closed its privateplacement financing for gross proceeds of $3,000,000 from the issuanceof 4,000,000 common shares at a price of $0.75 per common share. Inconnection with the closing, the Company paid a cash fee of 10% ofgross proceeds raised to an eligible finder.
On November 8, 2024, the Company announced theresignation of its Chief Financial Officer (“CFO”) and CorporateSecretary, Praveen Varshney, with immediate effect. On December 11,2024, the Company appointed James B. Murphy as its Chief FinancialOfficer (“CFO”).
Effective September 30, 2024, the Company changed itsregistrar and transfer agent from Computershare Trust Company toEndeavour Trust Corporation.
On September 10, 2024, the Company commenced trading onthe Frankfurt Boerse under the trading symbol “HBP0”.
Effective August 16, 2024, the common shares of theCompany commenced trading on a 1-for-5 consolidation basis under thenew CUSIP number 422910208 and existing stock symbol“HBP”.
Research & Development
Research & Development expenses for the year endedJuly 31, 2025, totaled $3,558,000 (2024: $5,977,000). The followingtable outlines research and development cost expenses for the currentand comparative year (in thousands of Canadian dollars):
Research and development expenditures for the yearended July 31, 2025, when compared to the year ended July 31, 2024,decreased by $2,419,000 or 40%. The change in spending during the yearwas the net effect of the conclusion of the Phase Ib/II study inmetastatic pancreatic adenocarcinoma (LDOS006), collaborative researchactivities carried out by third parties on behalf of the Company, andstock-based compensation expenses based on the timing of the vestingof stock options issued to employees and consultants associated withresearch activities in the quarters ended July 31, 2025 and 2024.
Operating, General andAdministration
Operating, general and administration expenses for theyear ended July 31, 2025, totaled $1,839,000 (2024: $3,262,000). Thefollowing table outlines operating, general and administrationexpenses for the current and comparative years (in thousands ofCanadian dollars):
Operating, general and administration expenses for theyear ended July 31, 2025, when compared to the year ended July 31,2024, decreased by $1,423,000 or 43%, primarily due to changes inservice providers relating to accounting and tax, legal, consultantsand business development.
Liquidity and CapitalResources
Since its inception, the Company has mainly relied onfinancing its operations from public and private sales of equity. TheCompany does not have any credit facilities and is therefore notsubject to any externally imposed capital requirements or covenants.The Company manages its liquidity risk by continuously monitoringforecasts and actual cash flow from operations and anticipatedinvestment and financing activities.
The Company reported a net loss and total comprehensiveloss of $5,205,000 or $0.09 per common share for the year ended July31, 2025, (July 31, 2024: $9,264,000 or $0.21 per common share). As ofJuly 31, 2025, the Company had a working capital deficiency of$2,807,000, shareholders’ deficiency of $15,586,000 and anaccumulated deficit of $215,876,000.
On January 8, 2025, the Company closed its privateplacement financing for gross proceeds of $3,000,000 from the issuanceof 4,000,000 common shares at a price of $0.75 per common share. Inconnection with the closing, the Company paid a cash fee of 10% ofgross proceeds raised to an eligible finder.
On April 21, 2025, the Company issued 125,000 commonshares for the exercise of 125,000 stock options for cash proceeds of$113,000.
On May 20, 2025, the Company closed the Laevoroc assetacquisition transactions, acquiring substantially all of the assetsand certain liabilities of Laevoroc Immunology AG and LaevorocChemotherapy AG, in consideration for the issuance of 11,555,076common shares at a fair value of $9,880,000, and 9,454,153 commonshares at a fair value of $8,083,000, respectively.
On August 16, 2024, the Company completed aone-for-five (1:5) consolidation of all of its issued and outstandingcommon shares, resulting in a reduction in the issued and outstandingshares from 245,107,749 to 49,021,536 common shares. Shares reservedunder the Company’s equity and incentive plans were adjusted toreflect the Consolidation. The Consolidation was approved by theCompany’s shareholders at the Annual General Meeting held on January18, 2024 and became effective on August 16, 2024. No fractional commonshares are issued in connection with the Consolidation, which are, ifany, deemed to have been tendered by its registered owner to theCompany for cancellation for no consideration.
As at July 31, 2025, the Company’s cash reserves of$65,000 are insufficient to meet anticipated cash needs for workingcapital and capital expenditures through the next twelve months, norare they sufficient to see the current research and developmentinitiates through to completion. To the extentthat the Company does not believe it has sufficient liquidity to meetits current obligations, management considers securing additionalfunds primarily through equity arrangements to be of utmostimportance.
The Company’s Statement of Financial Position andStatement of Net Loss and Comprehensive Loss for the fiscal year 2025and 2024 are summarized below:
Statements of FinancialPosition in Thousands of CanadianDollars | Statements of Net Loss andComprehensive Loss in Thousands of CanadianDollars |
The Company’s financial statements, management’sdiscussion and analysis and annual information form will be filedunder the Company’s profile on SEDAR+ at https://www.sedarplus.ca/ ,as well as on the Company’s website at www.helixbiopharma.com .
About Helix BioPharma Corp.
Helix BioPharma is an oncology company that innovatesfrom strength to bring near-term solutions for today’shardest-to-treat cancers. The Company’s pipeline is led by TumorDefense Breaker™ L-DOS47, a clinical-stage antibody-enzyme conjugatedesigned to prime CEACAM6-expressing tumors for increased sensitivityto therapy and augment the effectiveness of today’s front-runninganti-cancer treatments. L-DOS47 has completed Phase Ib studies innon-small cell lung cancer (NSCLC) and shares its CEACAM6-targetingfoundation with Helix’s next-generation bi-specific antibody-drugconjugates (ADCs), currently in discovery. The Company also advancestwo pre-IND candidates: (i) LEUMUNA™, an oral immune checkpointmodulator aimed at achieving durable remission in post-transplantleukemia relapse, and (ii) GEMCEDA™, a first-in-class oralgemcitabine prodrug with bioavailability on a par with IV, designed toexpand treatment options for advanced cancers.
Helix is listed on TSX (HBP), OTC PINK (HBPCD), and FWB(HBP0). For more information, pleasevisit : https://www.helixbiopharma.com/
For more information, pleasecontact:
Helix BioPharma Corp.
Bay Adelaide Centre - North Tower
40 Temperance Street, Suite 2
Toronto, ON M5H 0B4
Tel: +1 857 208 7687
Thomas Mehrling, CEO
Forward-Looking Statements and Risksand Uncertainties
This news release containsforward-looking statements and information (collectively,“forward-looking statements”) within the meaning of applicableCanadian securities laws. Forward-looking statements are statementsand information that are not historical facts but instead includefinancial projections and estimates, statements regarding plans,goals, objectives, intentions and expectations with respect to theCompany’s future business, operations, research and development,including the Company’s activities relating to Tumor DefenseBreaker™ L-DOS47, LEUMUNA™ and GEMCEDA™. 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 arenecessarily based on a number of estimates and assumptions that theCompany considered appropriate and reasonable as of the date suchinformation is given, including but not limited to the assumptionsregarding the implied benefits of the transactions. Forward-lookingstatements are subject to known and unknown risks, uncertainties, andother factors, many of which are beyond the Company’s control, thatmay cause actual results, performance or achievements to be materiallydifferent from those expressed or implied by such forward-lookingstatements, including but not limited to the risk that theCompany's assumptions on which its forward-looking statements arebased may not be accurate; the ability of the Company to capitalize onthe potential benefits of the transactions; and the risk factorsdisclosed in the Company's periodic reports publicly filed andavailable on its SEDAR+ profile at www.sedarplus.ca . No assurance can be given that any ofthe events anticipated by the forward-looking statements willtranspire or occur. There is no assurance that the proposedtransactions will be completed in accordance with its terms or at all.The forward-looking statements contained in this news release are madeas of the date of this announcement and the Company does not assumeany obligation to update any forward-looking statement or informationshould those beliefs, assumptions, opinions or expectations, or othercircumstances change, except as required by law.
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