Helix BioPharma Corp. Fiscal 2025 Year-End Results and Strategic Update FAQ

What are the key financial results for Helix BioPharma Corp. for fiscal year 2025?

The Company reported a net loss and total comprehensive loss of $5,205,000 for the year ended July 31, 2025, compared to $9,264,000 in 2024, and a loss of $0.09 per common share compared to $0.21 per common share in the previous year.

What strategic changes did Helix BioPharma make in 2024?

The Company decided to focus resources on developing L-DOS47 as a combination therapy with pembrolizumab for NSCLC, terminated research collaborations with University of Tuebingen and Peter Mac, closed its Edmonton laboratory, and reviewed CMC practices while engaging with Contract Drug Manufacturing Organizations.

What is L-DOS47 and what is its new focus?

L-DOS47 is Helix BioPharma’s clinical-stage asset that will now be developed as a combination therapy with PD-1 inhibitor pembrolizumab as first-line therapy for Non-Small Cell Lung Carcinoma (NSCLC).

What is the status of the LDOS007 clinical trial?

LDOS007 is a new Phase Ib/Randomized Phase II study to assess L-DOS47 in combination with pembrolizumab as first-line therapy in NSCLC, currently in the planning stage, with positive FDA feedback received on August 8, 2025.

Why did Helix BioPharma decide to focus on NSCLC?

The decision was based on an extensive expert review of available data, the significant unmet medical need in NSCLC despite immunotherapy being standard of care, and assessment of where tumor alkalization therapy is most likely to deliver meaningful clinical impact with the shortest time to FDA approval.

What happened to the Company’s previous research collaborations?

Research collaborations with University of Tuebingen, Germany (terminated August 9, 2024) and Peter Mac, Australia (terminated August 13, 2024) were ended as these projects were outside the scope of the new NSCLC focus.

What is the status of the pancreatic cancer trial (LDOS006)?

The Phase Ib/II combination trial in metastatic pancreatic adenocarcinoma evaluating L-DOS47 with doxorubicin was completed in October 2024, with data and sample analyses ongoing and the Clinical Study Report expected fall 2025.

What feedback did the Company receive from the FDA regarding LDOS007?

The FDA provided positive and constructive written feedback on the LDOS007 study design on August 8, 2025, indicating the Company could proceed without a scheduled End-of-Phase I meeting, allowing them to move directly to preparing the Clinical Trial Application.

What changes were made to the Company’s operations and facilities?

The Company closed its laboratory in Edmonton, Canada on October 31, 2024, liquidated laboratory equipment, and arranged for safekeeping of documents, reagents, and lab samples with a third-party storage provider.