An anonymous director reports

HELIX BIOPHARMA CORP. ANNOUNCES FISCAL 2024 FIRST QUARTER RESULTS

Helix BioPharma Corp. today released its financial results for the fiscal 2024 first quarter results for the period ending Oct. 31, 2023.

Overview

The company reported a net loss and total comprehensive loss of $1,254,000 for the three months ended Oct. 31, 2023 (Oct. 31, 2022 -- $1,606,000), and a loss of one cent per common share (July 31, 2023 -- loss of one cent per common share).

Clinical development

On Oct. 13, 2023, the company presented new preclinical data on L-DOS47 in combination with PD1 checkpoint inhibition at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, via in-person attendance. The title of the poster presentation was: Neutralizing Acidosis with ADC L-DOS47 Urease Immunoconjugate Enhances Response to Anti-PD1 Checkpoint Blockade in a Preclinical Orthotopic Model of Pancreatic Adenocarcinoma.

On Aug. 28, 2023, the company together with its partner Moffitt Cancer Center, Florida, published data on BioRxiv confirming the effectiveness of L-DOS47 in combination with anti PD-1 in pancreatic cancer. Statistically significant improvements in tumour regression were observed when combining L-DOS47 with anti-PD1 compared with each compound alone.

LDOS47 in lung cancer

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 pandemic lockdown and the final clinical trial report was further delayed amidst war in Ukraine where all subjects were recruited. The company is now preparing to submit the final clinical study report to regulatory authorities later this month.

LDOS47 in pancreatic cancer

The company's phase I-b/II combination trial in pancreatic cancer (LDSOS006) continues to recruit patients, now in the fourth dosing cohort (13.55 microg/kilogram), after successfully completing the second dosing cohort (nine microg/kg) in July, 2023. The company remains committed to this study.

Another important aspect of the development of the LDOS47 platform is the combination with chemo- and/or immuno-therapy to enhance current therapies, that may boost the utility of the platform. The company continues to engage several key opinion leaders to evaluate potential combinations for partnership opportunities in other CEACAM6 expressing tumours.

Corporate development

On Aug. 15, 2023, the company announced that it had closed a private placement financing for net proceeds of $2,998,000 from the issuance of 16,655,557 common shares at a price of 18 cents per common share. The common shares issued pursuant to the private placement were subject to a statutory hold period of four months and one day ending on Dec. 16, 2023, in accordance with applicable securities law. In connection with the closing, the company paid a cash fee of 10 per cent of gross proceeds raised to an eligible finder.

On Nov. 3, 2022, the company announced that it had closed a private placement financing for net proceeds of $4,629,019.86 from the issuance of 25,716,777 common shares at a price of 18 cents per common share. The common shares issued pursuant to the private placement were subject to a statutory hold period of four months and one day ending on March 4, 2023, in accordance with applicable securities law. In connection with the closing, the company paid a cash fee of 10 per cent of gross proceeds raised to an eligible finder.

On Oct. 3, 2022, the company announced the appointment of Dr. Frank Gary Renshaw as the chief medical officer.

Research and development

Research and development expenses for the three months ended Oct. 31, 2023, totalled $949,000 (2022 -- $1.3-million).

The attached table outlines research and development costs expenses for the current and comparative periods (in thousands of Canadian dollars).

Research and development expenditures for the three months ended Oct. 31, 2023, when compared with the three months ended Oct. 31, 2022, were lower by $351,000 or 27 per cent. The decrease in spending is covered most areas of expenditures including those associated with clinical and preclinical research and development activities. Stock-based compensation expenses were similar while salaries and benefits were lower by $31,000 when compared with the three months ended Oct. 31, 2022).

Operating, general and administration

Operating, general and administration expenses for the three months ended Oct. 31, 2023, totalled $303,000 (2022 -- $285,000 ).

The attached table outlines operating, general and administration expenses for the current and comparative periods (in thousands of Canadian dollars).

Operating, general and administration expenditures for the three months ended Oct. 31, 2023, when compared with the three months ended Oct. 31, 2022, were higher by $18,000 or 6 per cent.

Since May, 2022, the company has made significant efforts to control and reduce its overheads expenditures. This included closing its headquarters at Richmond Hill Ontario and moving it to Grove Corporate Services offices (Grove) in downtown Toronto. The company hired Grove to perform accounting and corporate secretarial services following the resignation of its previous chief financial officer 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 period.

In general, administrative savings were made in operating expenses ($137,000), wages were higher by ($12,000), and director and IR fees were higher by ($136,000). Stock-based compensation was higher by $18,000.

Liquidity and capital resources

Since inception, the company has mainly relied on financing its operations from public and private sales of equity. The company does not have any credit facilities and is therefore not subject to any externally imposed capital requirements or covenants.

The company manages its liquidity risk by continuously monitoring forecasts and actual cash flow from operations and anticipated investment and financing activities.

The company reported a net loss and total comprehensive loss of $1,254,000 for the three months ended Oct. 31, 2023 (2022 -- $1,606,000), and a loss of one cent per common share (2022 -- one cent per common share). As of Oct. 31, 2022, the company had a working capital deficiency of $877,000, shareholders' equity deficiency of $844,000 and a deficit of $201,407,000.

On July 19, 2023, the company applied to the Toronto Stock Exchange to price protect a proposed $3-million financing of common shares at a price of 18 cents per share. The TSX granted the conditional approval of the placement on July 19, 2023. On Aug. 15, 2023, the company announced that it had closed the private placement financing for gross proceeds of $2,998,000 from the issuance of 16,655,557 common shares at a price of 18 cents per common share.

On Sept. 12, 2022, the company applied to the TSX to price protect a proposed $5-million financing of common shares at a price of 18 cents per share. The TSX granted a price protection letter on Sept. 14, 2022, and the conditional approval of the placement on Sept. 26, 2022. On Nov. 3, 2022, the company announced that it had closed a private placement financing for net proceeds of $4,629,020 from the issuance of 25,716,777 common shares at a price of 18 cents per common share with insiders subscribing for $270,000. The common shares issued pursuant to the private placement are subject to a statutory hold period of four months and one day ending on March 4, 2023, in accordance with applicable securities law. In connection with the closing, the company paid a cash fee of 10 per cent of gross proceeds raised to an eligible finder.

In order for the company to advance the currently planned preclinical and clinical research and development activities, its collaborative scientific research programs, and pay for its overhead costs, the company will need to raise approximately $11-million through to the end of fiscal 2025. The company projects an average monthly fixed overhead spend of approximately $120,000. This amount does not include the costs related to any of the company's third party activities such as clinical studies, collaborative research activities and contract manufacturing.

The company's statement of financial position and statement of net loss and comprehensive loss for fiscal 2023 and 2022 are summarized in the attached table.

The company's consolidated financial statements, management's discussion and analysis and annual information form will be filed under the company's profile on SEDAR+, as well as on the company's website.

About Helix BioPharma Corp.

Helix 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. Helix is listed on the Toronto Stock Exchange under the symbol HBP.

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