On December 9, 2021 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported financial results for the 2021 fiscal year ended July 31, 2021 (Press release, Helix BioPharma, DEC 9, 2021, View Source [SID1234597359]).
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The Company reported a net loss and total comprehensive loss of $8,038,000 or $0.06 loss per common share for fiscal 2021 (2020-$8,985,000 or $0.07 loss per common share). Clinical development Phase I combination therapy study in lung cancer (LDOS001): Final clinical study report expected to be completed in December 2021; 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. The Company ceased patient enrolment into the trial in 2020 and proceeded to data analysis. As previously announced, the Company will not be advancing the randomized portion of the study without third-party partner funding. To date, no third-party partner has been identified. Phase Ib/II combination trial in pancreatic cancer (LDSOS006):
Two dose limiting toxicity events (each, a "DLT") have been reported in the first cohort ("Cohort 1") of the trial. As a result of an amended protocol, an additional three
(3) patients are required for this trial, bringing the total number of patients required to complete Cohort 1 to nine (9) patients. The Company currently continues to enroll patients in Cohort 1; If another DLT is observed in Cohort 1, the Company will not be able to complete the currently planned dose escalation plan, but instead will be required to design a protocol revision; On November 15, 2021, the Company applied for a revision to the clinical protocol to the U.S. Food and Drug Administration ("FDA"). L-DOS47 immunotherapy chemo combination study in lung cancer: The Company engaged key opinion leaders on the feasibility and design of a possible immunotherapy chemo combination clinical study and had targeted a possible submission to the FDA by December 2021.
The Company is not currently in a position to make a submission to the FDA regarding the potential clinical study. Clinical drug product strategic review: The Company 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. This engagement includes input from key opinion leaders on the positioning 1 of possible combination therapies and the prioritization of current and/or any additional clinical indications. The Company expects the consulting firm’s report to be finalized by December 2021. Corporate development
On September 3, 2020, Helix Immuno-Oncology S.A., the Company’s former wholly-owned subsidiary ("HIO"), completed a direct financing with an arm’s length party, CAIAC Fund Management AG ("CAIAC"), as designated trustee of an alternative investment fund to be established, resulting in a further dilution of the Company’s holding in HIO from approximately 42.51% to 29.89% and a loss of the Company’s control in HIO. On December 22, 2020, the Company disposed of its remaining interest in HIO to CAIAC for gross proceeds of CDN$2,308,000 ($2,020,000 net of transaction costs). Effective October 21, 2020, the financial advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management AG and the investor relations and advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management Est. ("ACMest") were terminated by mutual agreement of the parties.
On December 4 and 30, 2020, the Company completed two private placements resulting in the issuance of 8,200,000 units ("Units") at a price of $0.50 per Unit for aggregate gross proceeds of $4,100,000. See Liquidity and Capital Resources below. In February 2021, BDO Canada LLP resigned as the Company’s auditors. The Company appointed Marcum LLP as its new auditors on June 24, 2021.
On May 11, 2021, the Company entered into a definitive convertible security funding agreement (the "Lind Agreement") with Lind Global Macro Fund, LP, a New York based institutional investment fund managed by The Lind Partners, LLC (collectively "Lind"). The Company closed the first tranche under the Lind Agreement on May 13, 2021 for gross proceeds of $3,500,000 (the "First Tranche"). See Liquidity and Capital Resources section below.
In the fourth quarter of fiscal 2021, the Company decided to defer its application to the Nasdaq Stock Market (the "NASDAQ") as a result of no longer being able to qualify for an accelerated cross border qualifying financing under the Multijurisdictional Disclosure System ("MJDS").
On August 19, 2021, the Company announced that Dr. Krzysztof Saczek had been appointed as a member of the board of directors of the Company (the "Board") effective immediately in connection with the resignation of Mr. Heman Chao as CEO, CSO and as a member of the Board. Mr. Chao’s resignation became effective on September 1, 2021 and Mr. Chaor assumed the position of Chair of the Company’s Scientific Advisory Board on the same date. On September 20, 2021, the Company announced the appointment of the company’s Chairman, Dr. Slawomir Majewski, as Interim Chief Executive Officer to hold office while the Board worked to identify and evaluate potential candidates as permanent CEO. Research and development Research and development expenses for fiscal 2021 totalled $5,880,000 (2020-$5,868,000)Research and development expenditures in fiscal 2021, when compared to fiscal 2020, were higher by $12,000. Higher collaborative research activity totaling $1,023,000 and salaries of $79,000 were offset by lower clinical study expenditures of $476,000, lower intellectual property patent expenses of $303,000, lower manufacturing and stability assay expenses of $136,000 and a reduction in stock-based compensation expense of $116,000.
The increase in collaborative research spend in fiscal 2021 compared to fiscal 2020 is related to the Company’s sublicensing agreement with HIO, whereby the Company was responsible to fund pre-clinical activity in exchange for future royalties and milestones. As part of the sub-licensing agreement, HIO is responsible for certain intellectual property expenditures.
In addition, the Company also incurred collaborative research spend in fiscal 2021 related to research activities with Moffitt Cancer Centre. Lower clinical operations spend in fiscal 2021 compared to fiscal 2020 are related to the Company’s LDOS003 Phase II clinical study in Poland and Ukraine as a result of enrollment being halted in the previous fiscal year, causing no further expenditures incurred in the current fiscal year. The Company intends to finalize reporting by March 2022 provided the Company’s disagreement over billings by the clinical research organization overseeing the program are resolved. The Company also incurred lower expenditures associated 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.
The Company’s LDOS006 Phase Ib/II pancreatic clinical study in the U.S. commenced enrollment in December 2019 during the early days of the coronavirus pandemic (COVID-19) which delayed the clinical trial patient enrollment. In early 2021, the Company added two additional new sites in an effort to increase the rate of patient enrollment and advance the study. The study is currently still in the first cohort. The decrease in intellectual property spend in fiscal 2021 compared to fiscal 2020 includes an amount totaling $135,000 which the Company invoiced to HIO as passthrough costs for reimbursement associated with the sublicensing agreement. This amount is included in receivables at July 31, 2021.
The decrease in manufacturing and stability assay spend in fiscal 2021 compared to fiscal 2020 of $136,000 mainly reflects the timing of manufacturing expenses related to the repolishing of older drug substance and the resulting lyophilization of new drug product where the expenses overlapped both fiscal years. Operating, general and administration Operating, general and administration expenses for fiscal 2021 totalled $3,251,000 (2020-$2,748,000).The increase in operating, general and administration expenses of $503,000 in fiscal 2021 compared to fiscal 2020 reflects higher stock-based compensation expense, and higher expenses associated with various third-party advisory services such as legal, accounting, business development and investment banking services in an attempt to raise additional capital as part of a qualifying transaction to list the common shares in the capital of the Company ("Common Shares") on the NASDAQ or other United States stock exchange.
Several factors materialized that resulted in the Company eventually abandoning its plans to up-list on a U.S. stock exchange. These include but are not limited to the increase in the percentage ownership of the Common Shares by new insiders, a decline in the price of the Common Shares making it extremely challenging for the Company to leverage the MJDS, and the resignation of the Company’s previous auditors. Stock based compensation expense for fiscal 2021 totaled $663,000 (2020-$353,000).
The increase represents the expense associated with the vesting of stock options granted to directors, over their vesting period. 3 The reduction in investor relations expense for fiscal 2021 compared to fiscal 2020 mainly reflects the termination of the investor relations and advisory services agreement with ACMest. LIQUIDITY AND CAPITAL RESOURCES As at July 31, 2021 the Company had working capital of $144,000 (2020-$2,735,000), shareholders’ deficiency of $1,393,000 (2020 – shareholders’ equity of 2,981,000) and a deficit of $188,554,000 (2020-$180,516,000). On December 22, 2020, the Company disposed of its remaining interest in HIO for net proceeds of $2,020,000. See Corporate developments above. On December 4 and 30, 2020, the Company 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 ($3,561,000 net of transaction costs).
The sale of the Units resulted in the issuance of an aggregate of 8,200,000 Common Shares and 8,2000,000 Common Share purchase warrants ("Warrants"). Each Warrant entitles 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. On May 11, 2021, the Company entered into the Lind Agreement and on May 13, 2021, closed the First Tranche for gross proceeds of $3,500,000. In connection with the closing of the First Tranche, the Company issued a convertible security (a "Convertible Security") with a two-year term and a face value of $4,112,500 and issued an aggregate of 1,957,056 warrants exercisable into Common Shares for a period of 48 months at an exercise price of $1.0283 per Common Share.
The Convertible Security issued under the First Tranche accrues a simple interest rate obligation of 8.75% per annum on the amount funded, being $3,500,000, which interest is prepaid and attributed to the face value of the Convertible Security. The Lind Agreement also contemplates the issuance of a second Convertible Security upon the mutual agreement of the Company and Lind for gross proceeds to the Company of up to $6,500,000. Lind is entitled to convert the Convertible Securities issued under the terms of the Lind Agreement into Common Shares over their term, subject to certain limitations, at a conversion price equal to 85% of the five-day volume-weighted average trading price ("VWAP") of the Common Shares prior to the date a notice of conversion is provided to the Company by Lind. The Lind Agreement includes certain restrictions on the maximum face value of each of the Convertible Securities that may be converted in any particular month.
In addition, the Company has the option to buyback 66.7% of the Convertible Securities in cash at any time with no penalty, subject to the option of Lind to convert up to 1/3 of the face value of the Convertible Security into Common Shares at the time of such buy-back. The Lind Agreement is subject to covenant requirements. In the event of default Lind may declare, by notice to the Company, effective immediately, all outstanding obligations by the Company under the Funding Agreement to be immediately due and payable in immediately available funds and terminate the agreement. No such declaration has been made at time of filing of these annual consolidated financial statements. 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 $15,000,000 through to the end of fiscal 2023.
The Company projects an average monthly fixed overhead spend of approximately $275,000. 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 currently has one clinical study enrolling patients in LDOS006. Due to slow enrollment, the Company stopped LDOS001 enrollment and continues to work on finalizing the clinical study report. The Company is forecasting a cost of approximately $4,826,000 through to October 2023 to complete both the Phase Ib and Phase II portion of the study. Certain conditions need to be achieved in order for the Company to be able to progress through to the Phase II portion of the study. Of the forecasted $4,826,000, the portion attributable to Phase II is approximately $2,603,000 and is forecasted to begin sometime in May 2023. The Company is forecasting approximately $256,00 and $456,000, respectively to fully complete and report on both the LDOS001 and LDOS003 studies which are forecasted for December 2021 and March 2022, respectively. The Company is forecasting manufacturing expenditures of approximately $1,243,000 through to the end of fiscal 2023 in support of the Company’s clinical program. The Company previous forecasted a manufacturing technology transfer to a new manufacturer with a scaled-up production in anticipation of having sufficient supply for a contemplated pivotal trial and a new clinical study of L-DOS47 in combination with an immune-oncology drug.
The Company has since produced a new batch of drug product from previous drug substance providing additionally sufficient supply for the Company’s current clinical program, provided stability assays continue to meet protocol standards. 4 The Company is currently not forecasting any collaborative research enditures. The Company’s cash reserves of $3,565,000 as at July 31, 2021 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised during this fiscal year have assisted the Company in dealing with its immediate working capital requirements, additional funds are required to advance the Company’s clinical and preclinical programs and deal with future working capital requirements. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, preferably through the issuance of equity securities of the Company, to be critical for its development needs.
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 at www.sedar.com, as well as on the Company’s website at www.helixbiopharma.com.