Helix BioPharma Reports Narrowed Losses as It Shifts Focus to Lung Cancer Combination Therapy

Helix BioPharma Corp. reported a net loss of $5.2 million for the fiscal year ended July 31, 2025, representing a significant improvement from the $9.3 million loss recorded in the previous year. The clinical-stage oncology company reduced its loss per common share to $0.09 from $0.21 in 2024, while implementing a strategic shift toward developing its lead candidate L-DOS47 as a combination therapy for non-small cell lung cancer (NSCLC).

The company's narrowed losses reflect a deliberate restructuring of operations and research priorities. Research and development expenses decreased by 40% to $3.6 million, while operating, general and administration costs fell by 43% to $1.8 million. These reductions followed the company's decision to close its Edmonton laboratory in October 2024 and terminate research collaborations with University of Tuebingen in Germany and Peter Mac in Australia, redirecting resources toward the NSCLC focus.

Helix's strategic pivot centers on developing L-DOS47 in combination with PD-1 inhibitor pembrolizumab as first-line therapy for NSCLC. The company received positive written feedback from the U.S. Food and Drug Administration on August 8, 2025, regarding the study design for LDOS007, a planned Phase Ib/Randomized Phase II trial. This regulatory support allowed the company to proceed directly with preparing its Clinical Trial Application rather than holding a scheduled End-of-Phase I meeting.

The company completed its 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. The decision to focus on NSCLC was driven by expert review of available data, the significant unmet medical need in lung cancer despite immunotherapy advances, and assessment of where tumor alkalization therapy could deliver meaningful clinical impact in the near term.

Corporate developments throughout the fiscal year included significant leadership changes, with Thomas Mehrling, MD, PhD appointed as Chief Executive Officer on April 10, 2025, and Rohit Babbar named Chief Financial Officer on June 2, 2025. The company also strengthened its scientific leadership with the appointment of Veronika Kandziora as Chief Operating Officer on April 24, 2025.

Financing activities included a private placement generating $3 million on January 8, 2025, and a subsequent non-brokered private placement raising $1.7 million on August 22, 2025. The company also completed the acquisition of Laevoroc Immunology AG and Laevoroc Chemotherapy AG assets in May 2025, issuing approximately 21 million common shares valued at nearly $18 million collectively.

Despite these financial maneuvers, the company reported a working capital deficiency of $2.8 million and shareholders' deficiency of $15.6 million as of July 31, 2025. With cash reserves of only $65,000, management acknowledged insufficient liquidity to meet anticipated needs through the next twelve months or complete current research initiatives, emphasizing the priority of securing additional funding primarily through equity arrangements.

The company's financial statements and related documents are available through its SEDAR+ profile at https://www.sedarplus.ca/ and on the company website at https://www.helixbiopharma.com/. The strategic refocusing on NSCLC combination therapy represents a calculated bet on addressing one of oncology's most challenging treatment areas, with potential implications for lung cancer patients who have limited options despite immunotherapy advances.