Helix BioPharma Corp revealed that it had spent around $5.88 million on research and development (R&D) costs for the 2021 fiscal year ended July 31, 2021, as the biopharma continued to develop drugs to treat cancer.
The Richmond Hill, Ontario-based company’s DOS47 patented oncology platform technology offers a bold, new approach to the destruction of cancer cells by modulating the tumor microenvironment and turning it alkaline from acid, which, in turn, corrects an impaired immune system.
The biopharma company developing unique therapies in the field of immune oncology noted that higher collaborative research activity and salaries were offset by lower clinical study expenditures of $476,000, and lower patent expenses of $303,000. It also had lower manufacturing and stability assay expenses of $136,000.
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“The increase in collaborative research spend in fiscal 2021 compared to fiscal 2020 is related to the company's sub-licensing agreement with HIO, whereby the company was responsible to fund pre-clinical activity in exchange for future royalties and milestones,” said the company.
In addition, Helix also incurred collaborative research expenses in fiscal 2021 related to research activities with the Moffitt Cancer Centre.
In terms of clinical development, the company has advanced its Phase I combination therapy study in lung cancer (LDOS001). Helix said that it incurred lower expenses with its LDOS001 clinical study in the current fiscal year and is now finalizing the clinical study report, which is expected to be completed by December 2021.
Helix also gave an update on its Phase II combination therapy trial in lung cancer (LDOS003). “Final clinical study report expected to be completed in March 2022, provided the company settles a contractual disagreement with the clinical research organization engaged to oversee the study,” said Helix.
The company ceased patient enrolment into the trial in 2020 and proceeded to data analysis. As previously announced, Helix will not be advancing the randomized portion of the study without third-party partner funding.
Meanwhile, the company’s Phase Ib/II combination trial in pancreatic cancer (LDSOS006) in the US started enrollment in December 2019 during the early days of the pandemic, which delayed the clinical trial patient enrollment. In early 2021, the company added two additional new sites to increase the rate of patient enrollment and advance the study. “The study is currently still in the first cohort,” said the company.
Separately, Helix said it has engaged key opinion leaders on the feasibility and design of a possible L-DOS47 immunotherapy chemo combination study in lung cancer. The company said it has targeted a possible submission to the United States Food and Drug Administration (FDA) by December 2021.
Meanwhile, the company said its cash reserves of nearly $3.57 million as of July 31, 2021 are "insufficient to meet anticipated cash needs for working capital" through the next 12 months.
Although the funds raised during the fiscal year have helped Helix in dealing with its immediate working capital requirements, the company said that additional funds are required to advance its clinical and preclinical programs.
“Management considers securing additional funds, preferably through the issuance of equity securities of the company, to be critical for its development needs,” said Helix.
In the meantime, Helix has hired a biotechnology consulting firm to assess the company's drug product candidate with a focus on “identifying value propositions and positioning strategies” that would enable clinical adoption of L-DOS47.
The company expects the consulting firm's report to be finalized by December 2021.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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