Helix BioPharma Reports Narrowed Loss in Fiscal 2025 Amid Strategic Shift to NSCLC Focus

Helix BioPharma Corp. reported financial results for the fiscal year ended July 31, 2025, showing a net loss and total comprehensive loss of $5,205,000 compared to $9,264,000 in the previous year, representing a significant reduction in losses. The company's loss per common share decreased to $0.09 from $0.21 in the prior year, reflecting improved financial performance amid strategic restructuring. This financial improvement occurred as the company underwent substantial operational changes, including a strategic shift toward focusing resources on developing L-DOS47 as a combination therapy with PD-1 inhibitor pembrolizumab as first-line therapy for Non-Small Cell Lung Carcinoma.

The company's strategic review in the second half of 2024 resulted in several key decisions that shaped its current direction. Helix determined that focusing on NSCLC represented the most promising path forward based on expert review of available pre-clinical and clinical data, the significant unmet medical need in NSCLC despite immunotherapy advancements, and assessment of where pharmacological tumor alkalization therapy could deliver meaningful clinical impact in the near term. As part of this refocusing, the company terminated research collaborations with University of Tuebingen, Germany, and Peter Mac, Australia, on August 9, 2024 and August 13, 2024, respectively, as these projects fell outside the new NSCLC focus.

Operational changes included the closure of the company's laboratory in Edmonton, Canada, on October 31, 2024, with liquidation of laboratory equipment and safekeeping of documents, reagents, and lab samples with a third-party storage provider. The company also reviewed its chemistry, manufacturing, and controls practices and entered discussions with several Contract Drug Manufacturing Organizations to optimize resource expenditure and plan for manufacturing of the next drug batch. Research and development expenses for the year totaled $3,558,000, a decrease of $2,419,000 or 40% compared to the previous year, primarily due to the conclusion of the Phase Ib/II study in metastatic pancreatic adenocarcinoma and changes in collaborative research activities.

Clinical development progress included the completion of the Phase Ib/II combination trial in metastatic pancreatic adenocarcinoma in October 2024, with data and sample analyses ongoing and the Clinical Study Report expected in fall 2025. The company is now advancing LDOS007, a new Phase Ib/Randomized Phase II study to assess L-DOS47 in combination with pembrolizumab as first-line therapy in NSCLC. The company received positive and constructive written feedback from the U.S. Food and Drug Administration on the study design of LDOS007 on August 8, 2025, ahead of a planned End-of-Phase I meeting. As the FDA indicated the company could proceed without the meeting if written feedback was sufficiently clear, Helix elected to forego the videoconference in favor of preparing the Clinical Trial Application as the next step.

Corporate developments throughout the fiscal year included significant leadership changes and financial transactions. On April 10, 2025, the company appointed Thomas Mehrling, MD, PhD as Chief Executive Officer, replacing Jacek Antas, who continues as Director and Chairman of the Board. On June 2, 2025, Rohit Babbar was appointed Chief Financial Officer, replacing James B. Murphy. The company also completed several financing activities, including a private placement on January 8, 2025, that raised $3,000,000 from the issuance of 4,000,000 common shares at $0.75 per share. On August 22, 2025, the company closed a non-brokered private placement of 2,222,333 common shares at $0.75 per share for gross proceeds of $1,667,000.

The company's liquidity position remains challenging, with cash reserves of $65,000 as of July 31, 2025, insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months. Management considers securing additional funds primarily through equity arrangements to be of utmost importance. Operating, general and administration expenses decreased by $1,423,000 or 43% to $1,839,000, primarily due to changes in service providers relating to accounting and tax, legal, consultants and business development. The company's financial statements and related documents are filed on SEDAR+ at https://www.sedarplus.ca/ and available on the company website at https://www.helixbiopharma.com/.