Helix BioPharma Corp. (TSX:HBP) has announced its financial results for its fiscal first quarter ended October 31, 2022.
In addition to the results, the company also announced developments in LDOS47 in lung cancer therapy and LDOS47 in pancreatic cancer.
The company currently has three clinical studies in various stages of development.
READ:Helix BioPharma advances clinical development of lead candidate L-DOS47, but manages to decrease R&D expenses in 2022 fiscal year
The Phase I study combination therapy in lung cancer (LDOS001) final clinical trial report was issued in December 2021 and the manuscript was accepted for publication in the Journal of Thoracic Oncology Clinical and Research Reports on September 2, 2022.
The Phase II study of combination therapy in lung cancer (LDOS003) was halted in the dose escalation portion of the study in 2020 at the height of the pandemic lockdown and the final abbreviated clinical trial report has been further delayed amidst war in Ukraine where all subjects were recruited. A final effort is being made in an attempt to retrieve any data that is salvageable and conclude the study.
Another important aspect of the development of the LDOS47 platform is the combination with chemo- and/or immunotherapy, which may boost the utility of the platform.
The company has engaged several key opinion leaders to evaluate the feasibility of such combinations and aims to develop a roadmap by the second quarter of 2023.
LDOS47 in pancreatic cancer
Its Phase Ib/II combination trial in pancreatic cancer (LDSOS006) continues to recruit patients.
The second dosing cohort was successfully completed in November 2022 without any safety concerns and enrolment into the third dosing cohort (9 µg/kg) has now opened.
Corporate development
Corporate developments included:
- A two-year scientific collaboration agreement with the University Hospital Tubingen in Germany to assess the therapeutic response of L-DOS47 in several cancer models expressing CEACAM6, with advanced preclinical metabolic imaging.
- The completion of the buyback of the outstanding amount of the convertible security funding agreement with Lind Global Macro Fund, LP and the closing of the first tranche for gross proceeds of $3,500,000. The company has now bought back the amount outstanding of the convertible security under the agreement, which is C$2,061,875.
- The appointment of Dr. Gabrielle M Siegers, MA, Ph.D., as the Head of RD.
- The TSX approved its application to price protect a proposed $5 million financing of common shares at a price of $0.18 per share. As of October 31, 2022, the company has received a total of $4,629,020 in subscription receipts related to this financing with insiders subscribing for $270,000. On November 3, 2022, the company announced that it had closed a private placement financing for net proceeds of C$4,629,020 from the issuance of 25,716,777 common shares at a price of $0.18 per common share.
- It appointed Dr. Frank Gary Renshaw as the Chief Medical Officer.
- The appointment of Jacek Antas as the CEO of Helix replacing Artur Gabor who had resigned as the CEO and as a director of the company. Also, Malgorzata Laube was appointed to the board of directors.
Research and development
Research & development expenses for the three-month period ended October 31, 2022, totaled $1,300,000 (October 31, 2021– $1,249,000), up mainly due to higher expenditures associated with research and development activities by 3% as well as a 7% increase in business development cost.
Results
Operating, general and administration expenditures for the three-month period ended October 31, 2022, when compared to the three-month period ended October 31, 2021, were lower by $162,000 or 36%.
Since May 2022, the company has made significant efforts to control and reduce its overhead expenditures. This included closing its headquarters at Richmond Hill Ontario and moving it to Grove Corporate Services offices in downtown Toronto. The company hired Grove to perform accounting and corporate secretarial services following the resignation of its previous CFO in May 2022. The savings apply to various activities including salaries, rent, legal, and other operational expenditures. Further measures are being taken which will result in more reductions in the current year.
Wages and benefits fell by $60,000 or 61% due to the CFO position now being handled by the Grove Corporate Services contract which covers accounting, administration and corporate secretarial services.
Directors’ fees and investor relations were decreased by $93,000 or 91% after the company opted to restrict compensation to the directors to only stock-based compensation
Operating, general and administrative expenses for the three-month period ended October 31, 2022, totaled $285,000 (October 31, 2021 – $ 447,000).
The company reported a net loss and total comprehensive loss for the three-month period ended October 31, 2022, of $1,606,000 (October 31, 2021- $1,813,000)
During the three-month period, it completed two private placements resulting in the issuance of 8,200,000 units at a price of $0.50 per unit for aggregate gross proceeds of $4,100,000.
The sale of the units resulted in the issuance of an aggregate of 8,200,000 common shares and 8,200,000 warrants, with each such warrant entitling the holder thereof to purchase one common share at an exercise price of $0.70 for a period of five years from the date of issuance.
Helix BioPharma Corp. (TSX:HBP) is a clinical-stage biopharmaceutical company developing unique therapies in the field of immune-oncology for the prevention and treatment of cancer based on its proprietary technological platform DOS47.
Contact the author at jon.hopkins@proactiveinvestors.com