Helix BioPharma Corp. (TSX:HBP), focused on trying to combat killer cancers based on its DOS47 technological platform, reported that it advanced the development of its lead candidate L-DOS47, which is currently in clinical studies for lung and pancreatic cancer, while keeping a tight grip on research and development (R&D) expenses.
For the 2022 fiscal year ended July 31, 2022, the Toronto-based clinical-stage biopharmaceutical company reported R&D expenses of $4,544,000, a 29% decrease from $5,880,000 in the 2021 fiscal year.
“R&D expenditures for the year ended July 31, 2022, when compared to the year ended July 31, 2021, were lower by $1,318,000,” noted the company, while adding that the 29% decrease in R&D expenses partially offset the increases in consulting services and stock-based compensation.
In comparison to the fiscal year ended July 31, 2021, Helix also spent less on salaries and benefits by $195,000, or 15%, while consulting and stock-based compensation were higher by $943,000.
Helix said it hired biotech consultants to “assess” the company’s lead drug candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47.
In addition, Helix said the Phase I study for combination therapy in lung cancer (LDOS001) was completed and the final clinical trial report issued in December 2021. A manuscript was accepted for publication in the 'Journal of Thoracic Oncology Clinical and Research Reports' on September 2, 2022.
“Another important aspect of the development of the LDOS47 platform is the combination with chemo- and/or immuno-therapy, that may boost the utility of the platform,” noted Helix, while adding that it has engaged several key opinion leaders to “evaluate the feasibility of such combinations”. The company said it aims to develop a roadmap later this year.
LDOS47 in pancreatic cancer
The company's Phase I-b/II combination trial in pancreatic cancer (LDSOS006) continues to recruit patients. Helix said it recently applied to the US Food and Drug Administration (FDA) for a revision to the clinical study protocol to extend the number of treatment cycles for those patients where the benefits outweigh the risks.
“We remain committed to this study. The first dosing cohort was successfully completed and now the second dosing cohort is also nearing completion,” said Helix.
In a positive, Helix lowered its net loss and total comprehensive loss for fiscal 2022 to $6,563,000, or a loss of $0.04 per share, compared to a loss of $8,038,000, or loss of $0.06 per share in fiscal 2021.
During the year ended July 31, 2022, 12,346,938 warrants were exercised for a total subscription amount of $3,210,204. Helix also noted that as of October 31, 2022, the company has received a total of $4,644,000 in subscription receipts related to another financing.
Helix said that to advance its planned preclinical and clinical R&D activities, its collaborative scientific research programs and to pay for its overhead costs, it will need to raise around $11,000,000 through to the end of fiscal 2024.
Helix noted that it currently has three clinical studies in various stages. The company has completed the clinical study report for LDOS001 and submitted a final annual report to the FDA in April 2022.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive