Helix BioPharma Corp. (TSX: HBP, OTC: HBPCF, FRANKFURT: HBP0) announced its financial results for the fiscal year ended July 31, 2025, reporting a net loss and total comprehensive loss of $5,205,000, or $0.09 per common share, compared to a loss of $9,264,000, or $0.21 per common share, in fiscal 2024. The reduction in net loss reflects the company's strategic refocusing on its lead candidate L-DOS47 as a combination therapy for non-small cell lung carcinoma (NSCLC).
The company conducted an extensive review of its assets and forward strategy in the second half of 2024, leading to a decision to concentrate resources on developing L-DOS47 in combination with the PD-1 inhibitor pembrolizumab as first-line therapy for NSCLC. This decision was based on expert review of pre-clinical and clinical data, the significant unmet medical need in NSCLC despite immunotherapy advances, and an assessment of where pharmacological tumor alkalization therapy could deliver meaningful clinical impact. As part of this refocus, research collaborations with the University of Tuebingen, Germany, and Peter Mac, Australia, were terminated in August 2024, and the company closed its laboratory in Edmonton, Canada, on October 31, 2024.
Helix received positive written feedback from the U.S. Food and Drug Administration (FDA) on August 8, 2025, regarding the study design of LDOS007, a planned Phase Ib/Randomized Phase II trial evaluating L-DOS47 in combination with pembrolizumab as first-line therapy in NSCLC. The FDA indicated that the company could proceed without an End-of-Phase I meeting, and Helix elected to forego the videoconference to prepare the Clinical Trial Application. The study design includes an initial dose escalation safety lead-in followed by a randomized Phase II arm.
The company also completed its Phase Ib/II combination trial in metastatic pancreatic adenocarcinoma (LDOS006) in October 2024, with data analysis ongoing and the Clinical Study Report expected in fall 2025. Research and development expenses for the year totaled $3,558,000, down 40% from $5,977,000 in fiscal 2024, primarily due to the conclusion of the LDOS006 study and reduced collaborative research activities.
Operating, general and administration expenses decreased 43% to $1,839,000 from $3,262,000, mainly due to changes in service providers. As of July 31, 2025, the company had cash reserves of $65,000, a working capital deficiency of $2,807,000, and an accumulated deficit of $215,876,000. Helix acknowledged that its cash reserves are insufficient to meet anticipated needs through the next twelve months and that securing additional funds through equity arrangements is of utmost importance.
Corporate developments included the appointment of Thomas Mehrling, MD, PhD as CEO in April 2025, Rohit Babbar as CFO in June 2025, and Veronika Kandziora as COO in April 2025. The company closed a private placement in January 2025 for gross proceeds of $3,000,000 and another in August 2025 for $1,667,000. Additionally, Helix acquired substantially all assets of Laevoroc Immunology AG and Laevoroc Chemotherapy AG in May 2025, issuing common shares valued at $17,963,000. The company also announced it will not proceed with the GEM equity draw-down facility, citing misalignment with its capital strategy.
Helix's pipeline is led by L-DOS47, a clinical-stage antibody-enzyme conjugate designed to prime CEACAM6-expressing tumors for increased therapy sensitivity. The company also advances LEUMUNA™, an oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA™, an oral gemcitabine prodrug. Detailed financial statements are available on SEDAR+ at SEDAR+ and the company's website at Helix BioPharma.
