Helix BioPharma Amends Acquisition Agreements to Finalise Share Consideration ahead of Potential Financing

(TORONTO, ONTARIO, CANADA) December 6, 2024 | Newswire |  – 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 immune-oncology, based on its proprietary technological CEACAM6 platform, DOS47, announces that, further to its news releases dated November 29, 2024 and December 2, 2024, it has entered into amendment agreements with each of Laevoroc Immunology AG (“Laevoroc Immunology”) and Laevoroc Chemotherapy AG (“Laevoroc Chemotherapy”) to amend the consideration payable under the asset purchase agreements dated November 28, 2024, and November 30, 2024, respectively (the “Immunology Agreement” and the “Chemotherapy Agreement”).

Pursuant to an amendment agreement between the Company and Laevoroc Immunology dated December 5, 2024, the Company and Laevoroc Immunology have agreed to amend the Immunology Agreement to set the number of common shares issuable upon closing at 11,555,076 common shares, rather than a floating percentage of 16.5% of the number of issued and outstanding shares as of the closing date.

Similarly, pursuant to an amendment agreement between the Company and Laevoroc Chemotherapy dated December 5, 2024, the Company and Laevoroc Chemotherapy have agreed to amend the Chemotherapy Agreement to set the number of common shares issuable upon closing at 9,454,153 common shares, rather than a floating percentage of 13.5% of the number of issued and outstanding shares as of the closing date.

The Company amended the terms as a result of a potential financing deal that may close before the closing of the transactions, which, if consummated, would have led to unintended dilution and valuation adjustments. Management believes this approach allows the Company greater flexibility to negotiate financing terms while protecting shareholder value.

All shares issuable in connection with the transactions will be subject to a hold period of four months and one day from the date of issuance. Both transactions are subject to the approval of the Toronto Stock Exchange and certain closing conditions of transactions of a similar nature. The transactions are also subject to the approval of the Company’s shareholders, which the Company anticipates obtaining through written consent.

For more information on the transactions, please see the Company’s news releases dated November 13, 2024, November 29, 2024 and December 2, 2024.[i], [ii],[iii]

—ENDS—

[i] https://www.helixbiopharma.com/2024/11/13/helix-biopharma-corp-enters-into-non-binding-letter-of-intent-to-acquire-laevoroc-groups-oncology-assets/

[ii] https://www.helixbiopharma.com/2024/11/29/helix-biopharma-corp-enters-into-asset-purchase-agreement-to-acquire-oral-immune-checkpoint-inhibitor-and-expand-immune-oncology-portfolio/

[iii] https://www.helixbiopharma.com/2024/12/02/helix-biopharma-corp-enters-into-asset-purchase-agreement-to-acquire-oral-gemcitabine-chemotherapy-compound/

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 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, and the anticipated completion of the transactions, along with the financing. 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 that all conditions to the closing of the transactions will be met; the transactions will be completed on the terms currently contemplated; neither the Immunology Agreement or the Chemotherapy Agreement will be terminated prior to closing of the applicable transactions; and 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 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 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. The anticipated dates indicated above may change for a number of reasons, including delays in preparing materials in connection with the transactions, the inability to receive the necessary approvals in a timely manner, or the 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 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

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

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

[sibwp_form id=1]

This will close in 0 seconds

Tumor Defense Breaker™, L-DOS47


L‑DOS47 is a first‑in‑class, clinical-stage antibody‑enzyme conjugate designed to deliver a game-changing assist to anti-cancer immunity and today’s leading cancer immunotherapies for the treatment of prevalent, hard-to-treat solid tumors. The compound precisely targets CEACAM6, a cell-surface protein overexpressed in non‑small cell lung cancer (NSCLC) and other aggressive tumors, where it delivers an enzymatic payload that raises the extracellular pH of the acidic tumor microenvironment (TME). By neutralizing tumor acidity, L-DOS47 restores immune cell infiltration and activity, helps turn immunologically “cold” tumors “hot”, and enhances the therapeutic reach of immune checkpoint inhibitors. With patented composition-of-matter coverage through 2036 and demonstrated synergy with PD-1 inhibitor, pembrolizumab, L-DOS47 is poised to significantly increase the efficacy of immune checkpoint blockade and unlock broader and more durable responses in NSCLC and other aggressive solid tumors.

This will close in 0 seconds

LEUMUNA™


LEUMUNA™ is an oral immune checkpoint modulator designed to activate the donor immune system to recognize and fight relapsing leukemia in patients who have undergone allogeneic stem cell transplantation (allo-SCT). Although a life-saving procedure, up to 30% of patients who undergo allo-SCT see their cancer return, facing a median survival of just four months. LEUMUNA aims to offer these patients a new lease on life, by activating an immune cascade and inciting graft-versus-leukemia (GvL) effect, potentially offering long-term remission. Backed by strong preclinical data and a promising safety record from trials with its precursor compound, ulodesine, LEUMUNA offers a patient‑friendly, oral approach to a difficult-to-treat condition, with patent protection through 2041 and an Orphan Drug Designation granted by the US FDA.

This will close in 0 seconds

GEMCEDA™


GEMCEDA is a first-in-class oral prodrug of gemcitabine that opens up the possibility for convenient at-home administration, metronomic dosing and seamless integration into combination regimens with immune checkpoint inhibitors. To date, gemcitabine is only administered intravenously because oral forms have shown poor bioavailability of about 10%. GEMCEDA was developed as a prodrug to enable new uses of gemcitabine by combining it with cedazuridine, an enzyme inhibitor that helps boost its bioavailability to 90%. This remarkable innovation allows for greater flexibility in dosing schedules, fewer clinic visits, and a better quality of life, while achieving bioavailability on par with intravenous gemcitabine. Supported by a well‑established safety profile, scalable manufacturing, and patent coverage to 2043, GEMCEDA reimagines how chemotherapy can fit into patients’ lives.

This will close in 0 seconds