Helix BioPharma Reports Improved Financial Results Amid Strategic Shift to NSCLC Focus

Helix BioPharma Corp. reported a net loss of $5,205,000 for the fiscal year ended July 31, 2025, representing a significant improvement from the $9,264,000 loss reported in the previous year. The company's loss per common share decreased to $0.09 from $0.21 in 2024, reflecting progress in managing expenses while advancing its oncology pipeline. The company underwent a comprehensive strategic review in the second half of 2024 that resulted in a decisive shift toward focusing resources on developing L-DOS47 as a combination therapy with pembrolizumab as first-line treatment for non-small cell lung carcinoma.

This strategic pivot was informed by extensive analysis of preclinical and clinical data, consideration of unmet medical needs in NSCLC despite immunotherapy advances, and assessment of where tumor alkalization therapy could deliver meaningful clinical impact in the shortest timeframe to FDA approval. As part of this strategic realignment, Helix terminated research collaborations with University of Tuebingen in Germany and Peter Mac in Australia on August 9 and August 13, 2024, respectively, as these projects fell outside the new NSCLC focus. The company also closed its Edmonton laboratory on October 31, 2024, liquidating equipment while preserving documents and samples with third-party storage.

Manufacturing practices were reviewed, with discussions initiated with several Contract Drug Manufacturing Organizations to optimize resource allocation and plan for future drug production. The company's clinical development program saw completion of the Phase Ib/II combination trial in metastatic pancreatic adenocarcinoma (LDOS006) in October 2024, with data analysis ongoing and a Clinical Study Report expected in fall 2025. More significantly, the company is planning LDOS007, a new Phase Ib/Randomized Phase II study to assess L-DOS47 in combination with pembrolizumab as first-line NSCLC therapy.

The U.S. Food and Drug Administration provided positive written feedback on the study design on August 8, 2025, leading the company to forego a scheduled End-of-Phase I meeting and proceed directly with Clinical Trial Application preparation. Research and development expenses decreased by 40% to $3,558,000 for fiscal 2025, primarily due to the conclusion of the pancreatic cancer trial, reduced collaborative research activities, and timing of stock-based compensation vesting. Operating, general and administration expenses also declined by 43% to $1,839,000, attributed to changes in service providers for accounting, legal, consulting and business development functions.

Corporate developments included significant leadership changes, with Thomas Mehrling, MD, PhD appointed as Chief Executive Officer on April 10, 2025, replacing Jacek Antas, who remains as Director and Chairman. Veronika Kandziora was appointed Chief Operating Officer on April 24, 2025, while Rohit Babbar replaced James B. Murphy as Chief Financial Officer on June 2, 2025, supported by Brio Financial Group. The company strengthened its pipeline through the Laevoroc asset acquisition on May 20, 2025, acquiring substantially all assets of Laevoroc Immunology AG and Laevoroc Chemotherapy AG in exchange for common shares valued at $9,880,000 and $8,083,000 respectively.

Financing activities included a $3,000,000 private placement on January 8, 2025, and a $1,667,000 non-brokered private placement on August 22, 2025. The company also completed a one-for-five share consolidation effective August 16, 2024. Despite these improvements, the company reported a working capital deficiency of $2,807,000 and shareholders' deficiency of $15,586,000 as of July 31, 2025, with cash reserves of $65,000 insufficient to meet anticipated needs over the next twelve months. Management emphasized that securing additional funding through equity arrangements remains critical for continuing research and development initiatives. The company's financial statements and related documents are available through its SEDAR+ profile and on its corporate website.