Dr. Thomas Mehrling reports
HELIX BIOPHARMA (TSX: "HBP", OTC PINK: "HBPCD", FRANKFURT: "HBP0") SECURES PRE-IND CANDIDATES LEUMUNA AND GEMCEDA IN STRATEGIC ACQUISITION FROM THE LAEVOROC GROUP
Helix BioPharma Corp.
has closed the acquisitions of the assets of Laevoroc Immunology AG and Laevoroc Chemotherapy AG, pursuant to the asset purchase agreements dated Nov. 28, 2024, and Nov. 30, 2024, respectively, as amended.
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 (investigational new drug), 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 United States 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, 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 95 cents per share, which represents the closing price of the common shares on Dec. 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 Nov. 13, 2024, Nov. 29, 2024, Dec. 2, 2024, and Dec. 6, 2024.
Subsequently to the filing of the company's management information circular dated Jan. 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 per cent and
2.12
per cent, 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. Mehrling is a hemato-oncologist and pharmacologist with over 20 years of experience in the biopharmaceutical industry and a strong 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, United Kingdom, 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 tumours 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 centre. 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.
Dr. Mehrling, MD, PhD, chief executive officer 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 per cent of the shares of Laevoroc Medical AG CH, the majority shareholder of Laevoroc Immunology and 50 per cent 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
per cent 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 Hunenberg, 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 tumours 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 bispecific 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 posttransplant leukemia relapse, and (ii) Gemceda, a first-in-class oral gemcitabine pro drug with bioavailability on a par with IV, designed to expand treatment options for advanced cancers.
We seek Safe Harbor.
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