Helix BioPharma Reports Fiscal 2025 Results, Streamlines Focus on L-DOS47 Combination Therapy for NSCLC

Helix BioPharma Corp. announced its fiscal 2025 year-end results, revealing a narrowed net loss of $5.2 million, a strategic refocus on L-DOS47 combined with pembrolizumab for first-line NSCLC, and cash reserves insufficient to fund operations for the next twelve months.

Bay Area Metrowire Staff
Business
Helix BioPharma Reports Fiscal 2025 Results, Streamlines Focus on L-DOS47 Combination Therapy for NSCLC

Helix BioPharma Corp. (TSX: HBP, OTC: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company, today reported financial results for the fiscal year ended July 31, 2025, highlighting a reduced net loss and a strategic pivot toward its lead candidate L-DOS47 in combination with pembrolizumab for non-small cell lung carcinoma (NSCLC).

The company posted a net loss and total comprehensive loss of $5,205,000 for the year, compared to $9,264,000 in fiscal 2024, with a loss per share of $0.09 versus $0.21 the prior year. Research and development expenses decreased 40% to $3,558,000, primarily due to the conclusion of a Phase Ib/II study in pancreatic cancer and reduced collaborative research activities. Operating, general, and administration expenses fell 43% to $1,839,000, driven by changes in service providers.

Helix announced a strategic refocus on L-DOS47, an antibody-enzyme conjugate designed to alkalinize the tumor microenvironment, as a combination therapy with the PD-1 inhibitor pembrolizumab for first-line treatment of NSCLC. The decision followed an extensive review of preclinical and clinical data, the significant unmet medical need in NSCLC, and an assessment of where tumor alkalization therapy could deliver the most meaningful clinical impact. The company received positive written feedback from the U.S. Food and Drug Administration on the study design for the planned Phase Ib/Randomized Phase II trial (LDOS007) on August 8, 2025, and elected to proceed directly to preparing the Clinical Trial Application.

In line with this focus, Helix terminated research collaborations with the University of Tuebingen, Germany, and Peter Mac, Australia, in August 2024. The company closed its Edmonton, Canada laboratory on October 31, 2024, liquidating equipment and storing materials with a third-party provider. The Phase Ib/II trial in metastatic pancreatic adenocarcinoma (LDOS006) was completed in October 2024, with data analysis ongoing and the Clinical Study Report expected in fall 2025.

On the corporate front, Helix appointed Thomas Mehrling, MD, PhD, as CEO on April 10, 2025, and Veronika Kandziora as COO on April 24, 2025. Rohit Babbar was named CFO on June 2, 2025, supported by Brio Financial Group. The company also completed asset acquisition transactions for Laevoroc Immunology AG and Laevoroc Chemotherapy AG on May 20, 2025, issuing 20,019,229 common shares in consideration. A non-brokered private placement on August 22, 2025, raised $1,667,000 through the issuance of 2,222,333 common shares at $0.75 per share.

Despite these moves, Helix faces significant liquidity challenges. As of July 31, 2025, the company had cash reserves of only $65,000 and a working capital deficiency of $2,807,000. The company stated that its cash is insufficient to meet anticipated needs for working capital and capital expenditures through the next twelve months, nor to complete current research initiatives. Management considers securing additional funds through equity arrangements to be of utmost importance. The company reported an accumulated deficit of $215,876,000 as of July 31, 2025.

Helix’s financial statements and management discussion will be filed on SEDAR+ at www.sedarplus.ca and the company’s website at www.helixbiopharma.com.

Blockchain Registration

QR Code for Blockchain Registration