An anonymous director reports

HELIX BIOPHARMA CORP. ANNOUNCES FISCAL 2023 YEAR-END RESULTS

Helix BioPharma Corp. has released financial results for the 2023 fiscal year ended July 31, 2023.

Overview

The company reported a net loss and total comprehensive loss of $6.29-million for the year ended July 31, 2023 (July 31, 2022: $6,563,000), and a loss of three cents per common share (July 31, 2023: loss of four cents per common share.

Clinical development

LDOS47 in lung cancer

The phase 2 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 clinical trial report was further delayed amidst war in Ukraine, where all subjects were recruited. The company is preparing to submit the final clinical study report to regulatory authorities later this month.

LDOS47 in pancreatic cancer

The company's phase 1-b/2 combination trial in pancreatic cancer (LDSOS006) continues to recruit patients, now in the fourth dosing cohort (13.55 micrograms per kilogram) after completing the second dosing cohort (nine micrograms per kilogram) 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 immunotherapy 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:

• In August, 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.
• On Sept. 1, 2022, the company announced the appointment of Dr. Gabrielle M. Siegers, MA, PhD, as the head of RD, based out of the company's lab in Edmonton.
• On Aug. 30, 2022, the company announced that it had completed the buyback of the outstanding amount of the convertible security financing agreement with Lind Global Macro Fund LP. The company entered into the agreement with Lind in May, 2021, and closed the first tranche under the agreement for gross proceeds of $3.5-million shortly thereafter. The company has bought back the amount outstanding of the convertible security under the agreement, which is $2,061,875.
• On Aug. 9, 2022, the company announced that it has entered into a two-year scientific collaboration agreement with University Hospital Tubingen (Germany) to assess the therapeutic response of L-DOS47 in several cancer models expressing CEACAM6, with advanced preclinical metabolic imaging.

Research and development

Research and development expenses for the year ended July 31, 2023, totalled $5,281,000 (July 31, 2022: $4,544,000).

The attached table outlines research and development costs expensed (in thousands of dollars).

Research and development expenditures for the year ended July 31, 2023, when compared with the year ended July 31, 2022, were higher by $539,000 or 12 per cent. The increase in spending is mainly the result of higher expenditure associated with clinical and preclinical research and development activities. Stock-based compensation expenses were lower by $14,000, and salaries and benefits were lower by $67,000 when compared with the year ended July 31, 2022. The company hired biotechnology consultants 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.

Operating, general and administration

Operating, general and administration expenses for the year ended July 31, 2023, totalled $1,243,000 (July 31, 2022: totalled $1,496,000).

Operating, general and administration expenditures for the year ended July 31, 2023, when compared with the year ended July 31, 2022, were lower by $253,000 or 17 per cent. Since May, 2022, the company has made significant efforts to control and reduce its overhead expenditures. This included closing its headquarters at Richmond Hill, Ont., 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 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 year. In general, administrative savings were made in operating expenses ($80,000), wages ($275,000), and director and investor relations fees ($57,000). Stock-based compensation was higher by $160,000.

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 $6.29-million for the year ended July 31, 2023 (July 31, 2022: $6,563,000), and a loss of three cents per common share (July 31, 2022: four cents per common share). As of July 31, 2023, the company had a working capital deficiency of $877,000, shareholders equity deficiency of $844,000 and a deficit of $201,407,000. As of July 31, 2022, the company had working capital of $283,000, shareholders equity pf $319,000 and a deficit of $195,117,000.

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. In August, 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.

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 $200,000. 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 herein.

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.

We seek Safe Harbor.