Helix Biopharma Corp. Enters into Asset Purchase Agreement to Acquire Oral Gemcitabine Chemotherapy Compound

(TORONTO, ONTARIO, CANADA) December 2, 2024 | Newswire and EIN Presswire | — Helix BioPharma Corp. (TSX: “HBP”, OTC PINK: “HBPCD”, FRANKFURT: “HBP0”) (“Helix” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapies in immune-oncology, based on its proprietary technological CEACAM6 platform, DOS47, is pleased to announce it has entered into an asset purchase agreement dated November 30, 2024 (the “Agreement”) with Laevoroc Chemotherapy AG (“Laevoroc Chemotherapy”), a privately-held Swiss company.

Pursuant to the transaction (the “L-Chemo Transaction”), Helix will acquire the intellectual property, inventory, assigned agreements and rights to GEMCEDA, an oral gemcitabine chemotherapy combined with cedazuridine that near-matches the bioavailability of its intravenous counterpart, while providing a more tolerable treatment regimen for patients with prevalent, hard-to-treat cancers. Gemcitabine is a World Health Organization (WHO) Essential Medicine and GEMCEDA is a patented prodrug in preclinical development to offer a spectrum of disease-limiting and life-enhancing treatment outcomes for these patients.

Through the L-Chemo Transaction, Helix will acquire substantially all the assets and certain liabilities of Laevoroc Chemotherapy for 13.5% of Helix’ issued and outstanding common shares upon closing. If the L-Chemo Transaction were to close today, Helix would be required to issue 6,617,907 common shares (the “L-Chemo Consideration Shares”), based on the 49,021,536 shares currently issued and outstanding. All shares issuable under the L-Chemo Transaction will be subject to a hold period of four months and one day from the issuance date.

TSX/Shareholder Approval Requirements
Helix entered into an asset purchase agreement dated November 28, 2024 with Laevoroc Immunology AG (“Laevoroc Immunology”), whereby Helix agreed to acquire substantially all the assets and certain liabilities of Laevoroc Immunology for 16.5% of the Company’s issued and outstanding common shares upon closing (the “L-Immu Transaction”; together with the L-Chemo Transaction, the “Transactions”). If the L-Immu Transaction closed today, Helix would be required to issue 8,088,553 common shares (the “L-Chemo Consideration Shares”; together with the L-Immu Consideration Shares, the “Consideration Shares”), based on the 49,021,536 shares currently issued and outstanding. For more information on the L-Immu Transaction, please see Helix’ news release dated November 29, 2024.

If both Transactions closed today, Helix would be required to issue an aggregate 14,706,460 Consideration Shares. As such, issuance would exceed 25% of the Company’s outstanding securities on a non-diluted basis, and Helix is required to obtain shareholder approval for the Transactions, which it anticipates obtaining through written consent.

Both Transactions are subject to approval of the Toronto Stock Exchange and certain standard closing conditions. The Company anticipates the Transactions will close on or around January 30, 2025.

Jacek Antas, Helix Biopharma’s CEO, said: “Intravenous gemcitabine is a widely used anti-cancer agent and Laevoroc Chemotherapy has overcome one of the biggest hurdles in formulating it as an oral treatment: its bioavailability. We believe this asset is a great fit for Helix’ portfolio. Ultimately, the acquisition is part of an ambitious, pragmatic strategy to create a near future where hard-to-treat cancers are less hard-to-treat and deliver value to our shareholders.”

—ENDS—

About Helix BioPharma Corp.
Helix BioPharma Corp. is a clinical-stage biopharmaceutical company developing unique, immune-oncology therapies for the prevention and treatment of cancer based on its proprietary technological platform, DOS47. Helix is listed on the TSX under the symbol “HBP”, OTC PINK under “HBPCD” and FWB under “HBP0”.

For more information please contact:
Helix BioPharma Corp.
Bay Adelaide Centre – North Tower
40 Temperance Street, Suite 2
Toronto, ON M5H 0B4
Tel: +1 604-428-7050
Jacek Antas, Director
corporate@helixbiopharma.com 

Forward-Looking Statements, 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 not historical facts, but instead include financial projections and estimates, statements regarding plans, goals, objectives, intentions and expectations concerning Helix’ future business, operations, research and development, including Helix’ activities relating to DOS47 and the anticipated completion of the Transactions, individually or as a whole. Forward-looking statements can be identified by the use of forward-looking terminology, including “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 based on estimates and assumptions that Helix considered appropriate and reasonable on the date such information is given, including but not limited to assumptions that the Transactions will proceed according to Helix’ anticipated timelines; all conditions to the closing of the Transactions will be met; the Transactions will be completed on the terms currently contemplated; the Agreement and the L-Immu Agreement will not be terminated prior to closing of the L-Chemo Transaction and L-Immu Transaction, respectively; and the implied benefits of GEMCEDA. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors, many of which are beyond Helix’ 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 Helix’ assumptions on which its forward-looking statements are based may not be accurate; the inability to receive, in a timely manner and on satisfactory terms, the necessary approvals for the Transactions; the inability to satisfy, in a timely manner, all other conditions to the completion of the Transactions; the ability of Helix to capitalise on the potential benefits of GEMCEDA; and the risk factors disclosed in Helix’ periodic reports publicly filed and available on its SEDAR+ profile at www.sedarplus.ca. The anticipated dates indicated above may change for various reasons, including delays in preparing materials in connection with the Transactions, inability to receive the necessary approvals in a timely manner, or need for additional time to satisfy the conditions to the completion of the Transactions. 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 their respective terms or at all. The forward-looking statements contained in this news release are made as of the date of this announcement and Helix 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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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