HBP:CC - Helix BioPharma (TSX: HBP, OTC PINK: HBPCD, FRANKFURT: HBP0) Secures Pre-IND Candidates LEUMUNA(TM) and GEMCEDA(TM) in Strategic Acquisition from the Laevoroc Group
(TheNewswire)
May 20 ,2025 – TheNewswire - Toronto, Ontario – Helix BioPharma Corp. (TSX: “HBP” , OTC PINK: “HBPCD” ,FRANKFURT: “HBP0” ) ( “Helix” or the “Company” ), a clinical-stage oncology company shaping a near futurewhere today’s hard-to-treat cancers are vincible, is pleased to announce that the Company has closed theacquisitions of the assets of Laevoroc Immunology AG (“ Laevoroc Immunology ”) and Laevoroc Chemotherapy AG (“ Laevoroc Chemotherapy ”), pursuant to the asset purchase agreements datedNovember 28, 2024, and November 30, 2024, respectively, as amended(the “ Agreements ”).
Acquisition of LEUMUNA™ andGEMCEDA
With the closure of the Agreements, Helix has acquiredsubstantially all the assets of Laevoroc Immunology, comprising theintellectual property, inventory, assigned agreements and rights toLEUMUNA™ (LR 09, ulodesine hemiglutarate). LEUMUNA is a pre-IND,oral inhibitor of purine nucleoside phosphorylase (PNP) developed forthe treatment of leukemia relapse after allogeneic stem celltransplantation—a rare condition with a median survival of just fourmonths. i The compound hasdemonstrated significant survival benefits in mouse models of B Cellacute leukemia relapse and is supported by encouraging clinical safetyand efficacy data from predecessor and analog compounds. It is anovel, patented chemical entity discovered to be an immune checkpointmodulator and granted Orphan Drug Designation by the US Food and DrugAdministration (FDA) in 2022. ii , iii
In addition, Helix has acquired substantially all theassets of Laevoroc Chemotherapy, specifically the intellectualproperty, inventory, assigned agreements and rights to GEMCEDA™, apatented, oral gemcitabine prodrug combined with cedazuridine. GEMCEDAis a first-in-class, pre-IND candidate that overcomes the challengesassociated with the poor absorption of oral gemcitabine, achievingbioavailability on a par with its intravenous counterpart inpharmacokinetic studies in large animal models. Gemcitabine is a WorldHealth Organization (WHO) Essential Medicine and GEMCEDA is designedto offer more ways to fight and more ways to live for patients whosecancer has progressed, while minimizing their treatment burden.
Transaction Details
In consideration for the transactions, the Companyissued an aggregate of 21,009,229 common shares in the capital of theCompany (the “ ConsiderationShares ”), with 11,555,076 Consideration Sharesissued to Laevoroc Immunology and 9,454,153 Consideration Sharesissued to Laevoroc Chemotherapy. The Consideration Shares were issuedat a price of $0.95 per share, which represents the closing price ofthe common shares (the “ Shares ”) on December 5, 2024, the day beforethe Company entered into the amendment agreements. All ConsiderationShares issuable in connection with the transactions are subject to ahold period of four months and one day from the date of issuance. Formore information on the transactions, please see the Company’s newsreleases dated November 13, 2024, November 29, 2024, December 2, 2024and December 6, 2024. iv
Subsequently to the filing of the Company’smanagement information circular dated January 31, 2025, and obtainingshareholder approval of the transactions at the Company’s annualgeneral and special meeting held on March 26, 2025, Dr. Mehrlinginformed the Company that he and Dr. Zikopoulos are no longer actingjointly or in concert, with Dr. Mehrling indirectly exercising control over 13,393,383 Shares and Dr. Zikopoulosindirectly exercising control over 1,575,534 Shares ( representing approximately 18% and 2.12 %, respectively, of the issued andoutstanding Shares on a non-diluted basis, basedon 74,155,765 Shares issued and outstanding following closing). For more information with respect to Dr.Mehrling’s security holdings, please see the section titled“ Early Warning ReportDisclosure ” below.
Changes to the Board ofDirectors
In connection with the transactions, the Companygranted Laevoroc Immunology the right to nominate a single member ofthe board of directors of the Company. As such, the Company hasexpanded its board of directors through the appointment of Dr. ThomasMehrling as director of the Helix. Following this change, theCompany’s board is now comprised of five directors. Dr. Mehrling iscurrently also the Chief Executive Officer of the Company.
Dr. Thomas Mehrling
Dr. Thomas Mehrling is a Hemato-Oncologist andPharmacologist with over 20 years of experience in thebiopharmaceutical industry and a strong track record of buildingglobal oncology businesses. From 2003 to 2013, he served in successiveleadership roles at Mundipharma International, culminating in hisposition as Director of European Oncology—a capacity in which Dr.Mehrling led the establishment of the company’s first oncologydivision in Cambridge, UK, and completed the clinical development,registration and launch of two major products in Europe—DepoCyte®and Levact® (Ribomustin® and Treanda®). In 2013, he went on to leadthe establishment of the Mundipharma Group’s oncology start-up,Mundipharma EDO, focused on developing therapeutics for solid tumorsout of Basel, Switzerland. In 2019, Dr. Mehrling co-founded LaevorocMedical AG (formerly, Laevoroc Oncology AG), the majority shareholderof Laevoroc Immunology and Laevoroc Chemotherapy.
Earlier on in his career, Dr. Mehrling served as SeniorVice President of global CRO Medical Affairs at StaticonInternational, and as Medical Leader at Takeda European R&DCenter. Prior to transitioning to industry, he spent 13 years as an MDat the University Hospital in Frankfurt, where he also earned his MDdegree from the Department of Internal Medicine (Hemato-oncology andCardiology) and his PhD in Pharmacology. For more information on Dr.Mehrling’s background, please see the Company’s news release datedApril 10, 2025. v
Thomas Mehrling, MD, PhD, CEO andDirector of Helix, said “As co-founder of theLaevoroc companies, I’ve had the privilege of seeing LEUMUNA andGEMCEDA evolve from early scientific concepts into differentiated,first-in-class therapeutic candidates with real potential to transformcancer care. Their integration into Helix marks a strategicconsolidation of assets that strengthens our portfolio, supportscapital raising efforts, and advances our mission to bring smarter,more effective treatment options to people facing hard-to-treatcancers—and soon.”
EarlyWarning Report Disclosure
This news release is also being issued pursuant toNational Instrument 62-103 – The Early Warning System and Related Take-Over Bid and InsiderReporting Issues (“ NI 62-103 ”) inconnection with the issuance of the Consideration Shares.
Dr. Mehrling holds approximately 62.44% of the sharesof Laevoroc Medical AG CH (“ Laevoroc Medical ”), the majorityshareholder of Laevoroc Immunology and 50% shareholder of LaevorocChemotherapy. Immediately prior to the closing of the transactions,Dr. Mehrling did not beneficially own, directly or indirectly, orexercise control or direction over, any Shares or securitiesconvertible into or exercisable for Shares. Immediately following theclosing of the transactions, Dr. Mehrling acquired beneficialownership, directly or indirectly, or exercised control or direction, over 13,393,383 Shares (representing approximately 18 % of the issued and outstandingShares on a non-diluted basis, based on 74,155,765 Shares issued andoutstanding).
Dr. Mehrling acquired the Shares indirectly insatisfaction of the purchase price in connection with the transactionsand will indirectly hold the Shares for investment purposes. Dr.Mehrling intends to review the investment in the Company on acontinuing basis and may, from time to time and at any time, anddepending on market and other conditions, acquire or dispose ofequity, debt or other securities of the Company through open markettransactions, private placements and other privately negotiatedtransactions, or otherwise, in each case, depending on a number offactors, including general market and economic conditions and otherfactors and conditions Dr. Mehrling deems appropriate, including thecontractual resale restrictions applicable to the Shares.
Laevoroc Medical is a company incorporated under thelaws of Switzerland with a registered address of c/o Rothusstrasse 21,6331 Hünenberg, Switzerland.
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
Dr. Thomas Mehrling, CEO and Director
corporate@helixbiopharma.com
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 DOS47, LR 09 andGEMCEDA. Forward-looking statements can further be identified by theuse 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 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 the Company'sassumptions on which its forward-looking statements are based may notbe accurate; the ability of the Company to capitalize on the potentialbenefits of the transactions; and the risk factors disclosed in theCompany's periodic reports publicly filed and available 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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i References
https://pmc.ncbi.nlm.nih.gov/articles/PMC9850970/
ii https://www.jci.org/articles/view/160852
iii https://laevoroc.com/28-02-2023-laevoroc-immunology-announces-fda-orphan-drug-designation-granted-to-lr-09-a-novel-metabolic-immune-checkpoint-inhibitor-for-the-treatment-of-leukemia-relapse-after-allogeneic-st/
iv https://www.helixbiopharma.com/fy2024/helix-biopharma-corp-enters-into-non-binding-letter-of-intent-to-acquire-laevoroc-groups-oncology-assets/;https://www.helixbiopharma.com/fy2024/helix-biopharma-corp-enters-into-asset-purchase-agreement-to-acquire-oral-immune-checkpoint-inhibitor-and-expand-immune-oncology-portfolio/;https://www.helixbiopharma.com/fy2024/helix-biopharma-corp-enters-into-asset-purchase-agreement-to-acquire-oral-gemcitabine-chemotherapy-compound/;https://www.thenewswire.com/press-releases/1LaPF0JdM-helix-biopharma-amends-acquisition-agreements-to-finalise-share-consideration-ahead-of-potential-financing.html
v https://www.helixbiopharma.com/fy2015/helix-biopharma-corp-appoints-dr-thomas-mehrling-as-chief-executive-officer-to-drive-ambitious-clinical-development-plan/
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