November 13, 2024 – TheNewswire - Toronto, Ontario – Helix BioPharma Corp. (TSX: “HBP”, OTC PINK: “HBPCD”, FRANKFURT: “HBP0”) (“Helix” or the “Company), a clinical-stage biopharmaceutical company developing novel and unique therapies in the field of immuno-oncology, based on its proprietary technological CEACAM6 platform, DOS47, is pleased to announce that the Company has entered into a non-binding letter of intent (LOI) to acquire a 100% interest in the oncology assets of Laevoroc Chemotherapy AG and Laevoroc Immunology AG, both privately-held, Swiss oncology companies.

Laevoroc Chemotherapy’s asset is a novel, oral formulation of gemcitabine designed to be used as combination or maintenance therapy for high-prevalence, hard-to-treat cancers, including lung, pancreatic, ovarian and breast cancers. A WHO Essential Medicine, gemcitabine is currently available only in intravenous form. Formulated as an oral capsule, Laevoroc Chemotherapy’s GEMCEDA is expected to simplify care for patients with repeat, low-dose chemotherapy, offering improved convenience and fewer side effects.

Laevoroc Immunology’s asset is a novel, highly potent and selective inhibitor of purine nucleoside phosphorylase (PNP) in preclinical development for the treatment of leukaemia relapse following allogeneic stem cell transplantation (SCT). The PNP inhibitor, LR 09, was recently discovered to be a metabolic immune checkpoint inhibitor, offering the potential to initiate graft-versus-leukaemia effect and become the game-changing standard-of-care for this disease.1,2 LR 09 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in late 2022.

The non-binding LOI between the companies provides for a short exclusivity period during which the companies shall discuss Helix’ potential acquisition of the assets of Laevoroc Chemotherapy and Laevoroc Immunology. All three companies aim to close definitive agreements before year-end, upon completion of the requisite due diligence.

Thomas Mehrling, MD, PhD, CEO and Chairman of Laevoroc Chemotherapy and Immunology, said: “We are delighted that our novel assets will likely find a new home where their development will be expedited, and they can reach patients as soon as possible.”

Jacek Antas, CEO of Helix Biopharma, said: “Helix is thrilled about the prospect of acquiring the Laevoroc assets, which we think will contribute great synergies to our pipeline. We have the resources and will build a world-class team to drive the development forward and to create substantial value for our shareholders.”

About Helix BioPharma Corp.

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

For more information, please contact:

Helix BioPharma Corp.

Bay Adelaide Centre - North Tower

40 Temperance Street, Suite 2

Toronto, ON M5H 0B4

Tel: 604-428-7050

Jacek Antas, Director

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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. 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 statements about the future and are inherently uncertain and are necessarily based upon a number of estimates and assumptions that are also uncertain. Although the Company believes that the expectations reflected in such forward- looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Forward-looking statements, including financial outlooks, are intended to provide information about management’s current plans and expectations regarding future operations, including without limitation, future financing requirements, and may not be appropriate for other purposes. Certain material factors, estimates or assumptions have been applied in making forward-looking statements in this news release.

The Company’s actual results could differ materially from those anticipated in the forward-looking statements contained in this news release as a result of numerous known and unknown risks and uncertainties, including without limitation; the risk that the Company’s assumptions may prove to be incorrect; the risk that additional financing may not be obtainable in a timely manner, or at all, and that clinical trials may not commence or complete within anticipated timelines or the anticipated budget or may fail; third party suppliers of necessary services or of drug product and other materials may fail to perform or be unwilling or unable to supply the Company, which could cause delay or cancellation of the Company’s research and development activities; necessary regulatory approvals may not be granted or may be withdrawn; the Company may not be able to secure necessary strategic partner support; general economic conditions, intellectual property and insurance risks; changes in business strategy or plans; and other risks and uncertainties referred to elsewhere in this news release, any of which could cause actual results to vary materially from current results or the Company’s anticipated future results. Certain of these risks and uncertainties, and others affecting the Company, are more fully described in the Company’s annual management’s discussion and analysis for the year ended July 31, 2024 under the heading “Risks and Uncertainties” and Helix’s Annual Information Form, in particular under the headings “Forward-looking Statements” and “Risk Factors”, and other reports filed under the Company’s profile on SEDAR at www.sedar.com from time to time. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix’s management on the date of this new release, 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.

References

1 https://www.jci.org/articles/view/160852

2 https://www.nature.com/articles/d43747-023-00010-6