Helix BioPharma Secures Pre-IND Candidates LEUMUNA™ and GEMCEDA™ in Strategic Acquisition from the Laevoroc Group

May 20, 2025; Toronto, Ontario | The Newswire | 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. 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.

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.


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.

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.

Tags:

Jacek Antas

Chief Executive Officer

Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

This will close in 0 seconds

James B. Murphy

Chief Financial Officer

Mr. Murphy is a certified public accountant with over thirty years of experience in finance and operations management. He is currently a consultant with Danforth Advisors LLC (“Danforth”), a leading provider of outsourced strategic and operational specialists across functions in the life sciences industry. While at Danforth, Mr. Murphy has served over fifteen private and publicly held life sciences companies as CFO and CFO Advisor, helping them secure over USD 0.5 billion in financing and successfully execute pivotal asset transactions. Mr. Murphy functions as a consultant to Helix pursuant to a consulting agreement between the Company and Danforth.

This will close in 0 seconds

Thomas Mehrling

Medical Adviser

Thomas Mehrling (PhD in Pharmacology and MD) has over 20 years’ experience in multinational Pharma companies developing novel oncology compounds from preclinical research through to registration. Prior to entering the industry, he spent 13 years as an MD at the University Hospital in Frankfurt, working on preclinical and translational projects. He served as Director of European Oncology at Mundipharma International (2003–2013), building the company’s first European oncology business from the ground up out of Cambridge, UK, and completing the clinical development, registration and launch of two major products in Europe, DepoCyte® and Levact® (Ribomustin® and Treanda®). In 2013, he led the establishment of the Mundipharma Group’s start-up, Mundipharma EDO, developing anti-cancer therapeutics for solid tumours out of Basel, Switzerland.

This will close in 0 seconds

Christof Boehler

Chief Business Development Officer

Dr. Christof Boehler is a commercially oriented scientist with a proven track record in building and leading teams that successfully commercialize products and services in the life science industry. His core competencies are in technology transfer, business development and corporate governance with a focus on technology scouting, preclinical and clinical R&D, licensing, sales, capital raising and M&A.

Mr. Boehler is also a strategic advisor to Takeda.

This will close in 0 seconds

Kim Gaspar

Director Quality Assurance

Kim is the Director of Quality Assurance at Helix BioPharma Corp. An experienced quality assurance professional with expertise in Canadian, US, and EU regulations, she has been involved in all aspects of Phase I/II biopharmaceutical product development over the years, including regulatory submissions, QC laboratory compliance, tech transfer and third-party oversight of CMC activities, clinical QA, and bioanalytical data analysis. Kim joined Helix in 2000, transitioning into QA in 2003. She holds a B.Sc in Biochemistry and a Ph.D in Veterinary Physiological Sciences, both from the University of Saskatchewan.

This will close in 0 seconds

Brenda Lee

Director Clinical Operations

Brenda is the Clinical Operations Director at Helix Biopharma Corp. A clinical research operations professional with 25 years of experience managing clinical trials, ranging from early Phase I to late Phase IIIb/IV studies, she brings experience in clinical study protocol writing and development, trial start-up and vendor management, and a proven track record in planning and managing clinical trials to quality standards, timelines and budget. Brenda joined Helix Biopharma Corp. in 2018, working to advance the clinical program of L-DOS47. She holds B.Sc and M.Sc. degrees from the University of Toronto, specializing in Nutritional Sciences and Human Biology.

This will close in 0 seconds

Praveen Kumar

V.P. Drug Development

Praveen has experience working in the pharmaceutical industry for more than 25 years and has expertise in the development of drug products for small and macro-molecules using various dosage forms. He was involved in projects comprising the formulation development of generic drug products and their production and developed a novel transdermal drug product containing a protein-based drug (interferon alpha 2b) for the treatment of HPV infections.

Presently as a V.P. he manages the CMC-related activities (drug product formulation, technology transfer, quality, stability testing and interaction with regulatory agency) for the development of L-DOS47 drug product, an antibody drug conjugate, for the treatment of various cancers. He has a Ph.D. in Pharmaceutical sciences and he completed his post-doctoral fellowship in gene regulation. He was the author of multiple peer-reviewed published articles, a book chapter, and patents.

This will close in 0 seconds

Jerzy Leszczynski

Director

Jerzy Leszczynski is a shareholder of the Company, has spent more than 35 years developing businesses and has served in the capacity of board member of various real estate development companies. Mr. Leszczynski obtained his Master of Science in Chemistry from the Warsaw Institute of Technology.

This will close in 0 seconds

Janusz Grabski

Director, Chair of Audit Committee

Janusz (John) Grabski is a lawyer specialized in corporate and real estate law with over twenty years of experience.

This will close in 0 seconds

Malgorzata Laube

Director

Malgorzata Laube has over 19 years of experience in nuclear medicine. In her last role with Alberta Health Services, she was the Department Supervisor, Nuclear Medicine at Royal Alexandra Hospital. Ms. Laube obtained a MSc degree in Environmental Engineering from the Warsaw University of Technology and is based in Edmonton, Alberta, Canada.

This will close in 0 seconds

Jacek Antas

Chairman of the Board

Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

This will close in 0 seconds

Jonathan Davis

Advisor, ADC Discovery

Jonathan Davis received his Ph.D. from University of California, San Francisco, where he studied protein structure and function using NMR. After a post-doc at Harvard Medical School exploring RNA selection and structure in the labs of Jack Szostak and Gerhard Wagner, he went to work at EMD Serono, where his work involved improving antibody-based therapeutics, inventing a platform technology for generating heterodimeric Fcs as a basis for multifunctional molecules, and developing a novel scaffold based on an artificially-designed protein from David Baker’s lab. In 2008 he took a job at Bristol-Myers Squibb in Waltham/Cambridge MA, working on antibody discovery and platform development in a wide range of therapeutic areas, with a particular focus on multispecific therapeutics. He moved to Madison, WI in 2019 to take on the role of VP of Innovation and Strategy at Invenra, a biotech focused on bispecific antibodies, and where he is currently head of the Scientific Advisory Board. In early 2024 he left the corporate world to found Creative Antibodies, a consulting firm that helps guide companies to successful antibody discovery and development projects, from mAbs to multispecifics, ADCs, and other formats. Outside of science, Jonathan is a conservatory trained cellist, plays numerous other instruments, and founded the UCSF Orchestra (now Symphony Parnassus) in San Francisco, where he was Music Director for six years.

This will close in 0 seconds

Davide Guggi

Advisor, CMC

Davide graduated as a pharmacist and received his PhD in Pharmaceutical Technology and Biotechnology from the University of Vienna. He has over 20 years of experience in the pharmaceutical industry, principally in the field of oncology. At the beginning of his career, Davide led oncology business units and commercial departments at Mundipharma and Gilead across Austria and Eastern Europe. Since over 10 years he has been working as a CMC expert, covering operational and regulatory CMC functions on behalf of over 20 different small- and medium-sized biotech companies across the world. He has served as CMC Director and CSO/CTO for several years, developing both small molecules and biologics (mABs, Fab, ADCs and Radio-immuno-conjugates) from early discovery to NDA/BLA in the US, EU and Canada, with a focus on First-in-Human and Phase I/II studies in oncology indications.

This will close in 0 seconds

This will close in 0 seconds