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 future where today’s hard-to-treat cancers are vincible, is pleased to announce that the Company has closed the acquisitions of the assets of Laevoroc Immunology AG (“Laevoroc Immunology”) and Laevoroc Chemotherapy AG (“Laevoroc Chemotherapy”), pursuant to the asset purchase agreements dated November 28, 2024, and November 30, 2024, respectively, as amended (the “Agreements”).

 

Acquisition of LEUMUNA™ and GEMCEDA

With the closure of the Agreements, Helix has acquired substantially all the assets of Laevoroc Immunology, comprising the intellectual property, inventory, assigned agreements and rights to LEUMUNA™ (LR 09, ulodesine hemiglutarate). LEUMUNA is a pre-IND, oral inhibitor of purine nucleoside phosphorylase (PNP) developed for the treatment of leukemia relapse after allogeneic stem cell transplantation—a rare condition with a median survival of just four months.i The compound has demonstrated significant survival benefits in mouse models of B Cell acute leukemia relapse and is supported by encouraging clinical safety and efficacy data from predecessor and analog compounds. It is a novel, patented chemical entity discovered to be an immune checkpoint modulator and granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in 2022.ii,iii

 

In addition, Helix has acquired substantially all the assets of Laevoroc Chemotherapy, specifically the intellectual property, inventory, assigned agreements and rights to GEMCEDA™, a patented, oral gemcitabine prodrug combined with cedazuridine. GEMCEDA is a first-in-class, pre-IND candidate that overcomes the challenges associated with the poor absorption of oral gemcitabine, achieving bioavailability on a par with its intravenous counterpart in pharmacokinetic studies in large animal models. Gemcitabine is a World Health Organization (WHO) Essential Medicine and GEMCEDA is designed to offer more ways to fight and more ways to live for patients whose cancer has progressed, while minimizing their treatment burden.

 

Transaction Details

In consideration for the transactions, the Company issued an aggregate of 21,009,229 common shares in the capital of the Company (the “Consideration Shares”), with 11,555,076 Consideration Shares issued to Laevoroc Immunology and 9,454,153 Consideration Shares issued to Laevoroc Chemotherapy. The Consideration Shares were issued at a price of $0.95 per share, which represents the closing price of the common shares (the “Shares”) on December 5, 2024, the day before the Company entered into the amendment agreements. All Consideration Shares issuable in connection with the transactions are subject to a hold period of four months and one day from the date of issuance. For more information on the transactions, please see the Company’s news releases dated November 13, 2024, November 29, 2024, December 2, 2024 and December 6, 2024.iv

 

Subsequently to the filing of the Company’s management information circular dated January 31, 2025, and obtaining shareholder approval of the transactions at the Company’s annual general and special meeting held on March 26, 2025, Dr. Mehrling informed the Company that he and Dr. Zikopoulos are no longer acting jointly or in concert, with Dr. Mehrling indirectly exercising control over 13,393,383 Shares and Dr. Zikopoulos indirectly exercising control over 1,575,534 Shares (representing approximately 18% and 2.12%, respectively, of the issued and outstanding Shares on a non-diluted basis, based on 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 Report Disclosure” below.

 

Changes to the Board of Directors

In connection with the transactions, the Company granted Laevoroc Immunology the right to nominate a single member of the board of directors of the Company. As such, the Company has expanded its board of directors through the appointment of Dr. Thomas Mehrling as director of the Helix. Following this change, the Company’s board is now comprised of five directors. Dr. Mehrling is currently also the Chief Executive Officer of the Company.

 

Dr. Thomas Mehrling

Dr. Thomas Mehrling is a Hemato-Oncologist and Pharmacologist with over 20 years of experience in the biopharmaceutical industry and a strong track record of building global oncology businesses. From 2003 to 2013, he served in successive leadership roles at Mundipharma International, culminating in his position as Director of European Oncology—a capacity in which Dr. Mehrling led the establishment of the company’s first oncology division 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 lead the establishment of the Mundipharma Group’s oncology start-up, Mundipharma EDO, focused on developing therapeutics for solid tumors out of Basel, Switzerland. In 2019, Dr. Mehrling co-founded Laevoroc Medical AG (formerly, Laevoroc Oncology AG), the majority shareholder of Laevoroc Immunology and Laevoroc Chemotherapy.

 

Earlier on in his career, Dr. Mehrling served as Senior Vice President of global CRO Medical Affairs at Staticon International, and as Medical Leader at Takeda European R&D Center. Prior to transitioning to industry, he spent 13 years as an MD at the University Hospital in Frankfurt, where he also earned his MD degree from the Department of Internal Medicine (Hemato-oncology and Cardiology) and his PhD in Pharmacology. For more information on Dr. Mehrling’s background, please see the Company’s news release dated April 10, 2025.v

 

Thomas Mehrling, MD, PhD, CEO and Director of Helix, said “As co-founder of the Laevoroc companies, I’ve had the privilege of seeing LEUMUNA and GEMCEDA evolve from early scientific concepts into differentiated, first-in-class therapeutic candidates with real potential to transform cancer care. Their integration into Helix marks a strategic consolidation of assets that strengthens our portfolio, supports capital raising efforts, and advances our mission to bring smarter, more effective treatment options to people facing hard-to-treat cancers—and soon.”

 

Early Warning Report Disclosure

This news release is also being issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues (“NI 62-103”) in connection with the issuance of the Consideration Shares.

 

Dr. Mehrling holds approximately 62.44% of the shares of Laevoroc Medical AG CH (“Laevoroc Medical”), the majority shareholder of Laevoroc Immunology and 50% shareholder of Laevoroc Chemotherapy. Immediately prior to the closing of the transactions, Dr. Mehrling did not beneficially own, directly or indirectly, or exercise control or direction over, any Shares or securities convertible into or exercisable for Shares. Immediately following the closing of the transactions, Dr. Mehrling acquired beneficial ownership, directly or indirectly, or exercised control or direction, over 13,393,383 Shares (representing approximately 18% of the issued and outstanding Shares on a non-diluted basis, based on 74,155,765 Shares issued and outstanding).

 

Dr. Mehrling acquired the Shares indirectly in satisfaction of the purchase price in connection with the transactions and will indirectly hold the Shares for investment purposes. Dr. Mehrling intends to review the investment in the Company on a continuing basis and may, from time to time and at any time, and depending on market and other conditions, acquire or dispose of equity, debt or other securities of the Company through open market transactions, private placements and other privately negotiated transactions, or otherwise, in each case, depending on a number of factors, including general market and economic conditions and other factors and conditions Dr. Mehrling deems appropriate, including the contractual resale restrictions applicable to the Shares.

 

Laevoroc Medical is a company incorporated under the laws 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 innovates from strength to bring near-term solutions for today’s hardest-to-treat cancers. The Company’s pipeline is led by Tumor Defense Breaker™ L-DOS47, a clinical-stage antibody-enzyme conjugate designed to prime CEACAM6-expressing tumors for increased sensitivity to therapy and augment the effectiveness of today’s front-running anti-cancer treatments. L-DOS47 has completed Phase Ib studies in non-small cell lung cancer (NSCLC) and shares its CEACAM6-targeting foundation with Helix’s next-generation bi-specific antibody-drug conjugates (ADCs), currently in discovery. The Company also advances two pre-IND candidates: (i) LEUMUNA™, an oral immune checkpoint modulator aimed at achieving durable remission in post-transplant leukemia relapse, and (ii) GEMCEDA™, a first-in-class oral gemcitabine prodrug with bioavailability on a par with IV, designed to expand treatment options for advanced cancers.

 

Helix is listed on TSX (HBP), OTC PINK (HBPCD), and FWB (HBP0). For more information, please visit: https://www.helixbiopharma.com/

 

For more information, please contact:

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 Risks and Uncertainties

 

This news release contains forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws. Forward-looking statements are statements and information that are not historical facts but instead include financial projections and estimates, statements regarding plans, goals, objectives, intentions and expectations with respect to the Company’s future business, operations, research and development, including the Company’s activities relating to DOS47, LR 09 and GEMCEDA. Forward-looking statements can further be identified by the use of forward-looking terminology such as “ongoing”, “estimates”, “expects”, or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions “will”, “may”, “could”, or “should” occur or be achieved, or comparable terminology referring to future events or results.

 

Forward-looking statements are necessarily based on a number of estimates and assumptions that the Company considered appropriate and reasonable as of the date such information is given, including but not limited to the assumptions regarding the implied benefits of the transactions. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, including but not limited to the risk that the Company's assumptions on which its forward-looking statements are based may not be accurate; the ability of the Company to capitalize on the potential benefits of the transactions; and the risk factors disclosed in the Company's periodic reports publicly filed and available on its SEDAR+ profile at www.sedarplus.ca. No assurance can be given that any of the events anticipated by the forward-looking statements will transpire or occur. There is no assurance that the proposed transactions will be completed in accordance with its terms or at all. The forward-looking statements contained in this news release are made as of the date of this announcement and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.

_________________

 

iReferences

 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/