Helix BioPharma Reports Fiscal 2025 Results with Strategic Focus on NSCLC Combination Therapy

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. The loss per common share decreased to $0.09 from $0.21 in fiscal 2024, reflecting the company's ongoing efforts to streamline operations and focus resources on its most promising clinical programs.

The company conducted an extensive strategic review in the second half of 2024 that resulted in a decisive shift toward developing L-DOS47 as a combination therapy with PD-1 inhibitor pembrolizumab as first-line treatment for non-small cell lung carcinoma. This strategic pivot was informed by comprehensive analysis of available preclinical and clinical data, the significant unmet medical need in NSCLC despite immunotherapy advancements, and assessment of where tumor alkalization therapy could deliver meaningful clinical impact in the near term. The decision also considered the potential for accelerated FDA approval pathways.

As part of this strategic refocusing, Helix terminated research collaborations with University of Tuebingen, Germany, and Peter Mac, 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 and transferring documents, reagents, and lab samples to third-party storage. Additionally, Helix reviewed its chemistry, manufacturing, and controls practices and initiated discussions with multiple contract drug manufacturing organizations to optimize resource allocation and plan for future drug manufacturing.

The company's clinical development pipeline shows significant progress, with the Phase Ib/II combination trial in metastatic pancreatic adenocarcinoma (LDOS006) completing in October 2024. Data and sample analyses are ongoing, with the clinical study report expected in fall 2025. More importantly, the new Phase Ib/Randomized Phase II study LDOS007, which will assess L-DOS47 in combination with pembrolizumab as first-line therapy in NSCLC, received positive written feedback from the U.S. Food and Drug Administration on August 8, 2025. The FDA indicated the company could proceed without a planned End-of-Phase I meeting, allowing Helix to advance directly to preparing the clinical trial application. The study design includes an initial dose escalation safety lead-in investigating low, medium, and high L-DOS47 dose levels combined with standard pembrolizumab, followed by a randomized Phase II arm testing two selected L-DOS47 dose levels in combination versus standard pembrolizumab alone.

Research and development expenses for fiscal 2025 totaled $3,558,000, representing a 40% decrease from the previous year's $5,977,000. This reduction resulted from the conclusion of the Phase Ib/II pancreatic cancer study, changes in collaborative research activities with third parties, and timing differences in stock-based compensation expenses. Operating, general, and administration expenses also decreased by 43% to $1,839,000 from $3,262,000 in the prior year, primarily due to changes in service providers for accounting, tax, legal, consulting, and business development functions.

Corporate developments throughout the fiscal year included significant leadership changes and financing activities. The company appointed Thomas Mehrling, MD, PhD as Chief Executive Officer on April 10, 2025, with Veronika Kandziora joining as Chief Operating Officer on April 24, 2025, and Rohit Babbar appointed as Chief Financial Officer on June 2, 2025. Financing activities included a private placement closing on January 8, 2025, raising $3,000,000 through the issuance of 4,000,000 common shares at $0.75 per share, and another private placement on August 22, 2025, raising $1,667,000 through the issuance of 2,222,333 common shares at the same price. The company also completed the Laevoroc asset acquisition transactions on May 20, 2025, acquiring substantially all assets and certain liabilities of Laevoroc Immunology AG and Laevoroc Chemotherapy AG in exchange for common shares valued at $9,880,000 and $8,083,000, respectively.

As of July 31, 2025, Helix reported a working capital deficiency of $2,807,000, shareholders' deficiency of $15,586,000, and an accumulated deficit of $215,876,000. The company's cash reserves of $65,000 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months or to complete current research and development initiatives. Management considers securing additional funds primarily through equity arrangements to be of utmost importance. The company's financial statements, management's discussion and analysis, and annual information form will be filed under the company's profile on SEDAR+ and on the company's website at www.helixbiopharma.com.

The strategic focus on NSCLC combination therapy represents a significant development in oncology treatment, particularly given the persistent unmet medical needs in lung cancer despite immunotherapy advancements. The positive FDA feedback on the LDOS007 study design suggests regulatory alignment with Helix's approach, potentially accelerating development timelines. For investors and the oncology community, Helix's narrowed losses and strategic refocusing indicate a more targeted approach to drug development that could yield meaningful clinical benefits for NSCLC patients while optimizing resource allocation. The company's progress in securing financing and making key leadership appointments further supports its ability to execute on this refined strategy, though ongoing capital requirements remain a critical consideration for future development.