On October 30, 2020 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 its financial results for the 2020 fiscal year ended July 31, 2020 (Press release, Helix BioPharma, OCT 30, 2020, View Source [SID1234569584]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OVERVIEW

The Company reported a consolidated net loss and total comprehensive loss of $9,174,000 or $0.07 loss per common share for fiscal 2020 (2019-$7,526,000 or $0.07 loss per common share. This includes a net loss from discontinued operations in fiscal 2020 of $613,000 (2019-$719,000) related to the Company’s planned divestiture of Helix Immuno-Oncology S.A. ("HIO").

The Company began the year with a working capital deficiency of $3,534,000 until August 21, 2019 when the Company closed a series of private placements in fiscal 2020 for total gross proceeds of approximately $16,000,000. A portion of these private placement financings included the disposition of a 49.0% stake in HIO. On July 8, 2020 HIO completed a direct Series B private placement which resulted in a dilution of the Company’s holding in HIO down to 42.51% as at July 31, 2020 and subsequently on September 3, 2020, HIO closed a direct Series C private placement which further diluted the Company’s holding in HIO down to 29.89%.

On June 26, 2020, the Company announced that it had entered into agreements with HIO, pursuant to which the Company cancelled an aggregate amount of approximately $2,700,000 of intercompany debt owed to the Company by HIO. As a result, all transferred assets related to Biphasix and V-DOS47 have been automatically reassigned and transferred from HIO back to the Company without any formality. In addition, the Company also ceased financing HIO with immediate effect.

Also, on June 26, 2020, the Company announced the receipt of a non-binding offer for PLN6,700,000 from CAIAC Fund Management AG ("CAIAC") to purchase the Company’s remaining shares in HIO. The transaction was initially expected to close no later than August 31, 2020 but has since been deferred to the end of October 30, 2020, subject to the satisfaction of certain conditions. As of the filing date of this press release the Company has not yet closed the transaction with CAIAC though both parties continue to work through the process to finalize and close the transaction.

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. were terminated by mutual agreement of the parties.

As previously disclosed, the Company has also been in discussions, during the year, with various capital market firms, both in the U.S. and Canada, with the goal of raising additional sufficient capital to qualify for a NASDAQ listing and further advance the Company’s clinical development programs.

At present, the only clinical program enrolling patients is the Company’s U.S. Phase Ib/II LDOS006 study (L-DOS47 in combination with doxorubicin) in the treatment of patients with metastatic pancreatic cancer who have progresses 1 on at least two prior treatment regimens. COVID-19 had impacted patient enrollment and as a result, the Company is in the process of adding two additional clinical trial sites in other U.S. jurisdictions.

The Company’s clinical studies in non-small cell lung cancer patients, a U.S. Phase I LDOS001 study (L-DOS47 in combination with pemetrexed and carboplatin) and a European Phase II LDOS003 study (L-DOS47 in combination with vinorelbine and cisplatin), have completed patient enrolment.

For LDOS001, the Company is working through the process of completing the anti-drug antibody assays, which from a timing perspective, have been hampered by COVID-19. Once the analysis is complete, the clinical study database lock will be initiated with the goal of finalizing the clinical study report by April 2021.

As for LDOS003, the Company previous disclosed that the first stage of the study related to dose escalation would be concluded and that any progression to the second stage would only proceed if a third-party was willing to partner with the Company on the study. The Company is in a contractual dispute with the CRO that is managing the clinical study. Until such time the dispute is resolved, the Company expects a delay in completing final monitoring, close out activities and finalizing the clinical study report. The Company is currently in discussion with the CRO in order to resolve the matter.

Research and development

Research and development expenses for fiscal 2020 totalled $5,868,000 (2019-$4,948,000). L-DOS47 research and development expenses for fiscal 2020 totalled $4,715,000 (2019-$3,530,000).

L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., the LDOS003 Phase II clinical study in Poland and the Ukraine and the Company’s new LDOS006 Phase Ib/II pancreatic clinical study in the U.S.

For fiscal 2020 when compared to fiscal 2019 the increase in spending mainly reflects drug substance manufacturing spend of $590,000, costs associated with the new LDOS006 pancreatic trial in the U.S. of $1,144,000 and costs associated with finalizing and reporting on LDOS001 of $168,000. Offsetting the increased spend was a reduction in spending of $354,000 related to the Company’s LDOS003 and a further reduction of $278,000 related to the Moffitt Cancer Centre research collaboration.

CAR-T research and development expenses for fiscal 2020 totalled $64,000 (2019-$333,000). The Company’s collaboration with ProMab Biotechnologies Inc. has been impacted by the Coronavirus pandemic and as such certain planned activities have been deferred.

Trademark and patent related expenses for fiscal 2020 totalled $516,000 (2019-$435,000). The Company continues to ensure it adequately protects its intellectual property.

Stock based compensation expense for fiscal 2020 totalled $117,000 (2019-$197,000). The amount represents the expense associated with the vesting of stock options that were granted, over their vesting period.

Operating, general and administration

Operating, general and administration expenses for fiscal 2020 totalled $2,748,000 (2019-$1,827,000). The increase is mainly the result of higher expenses associated with various third-party advisor services such as investor and media relations, legal, business development activities and investment banking services. During the year, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ. Stock based compensation expense for fiscal 2020 totalled $353,000 (2019-$164,000). The amount represents the expense associated with the vesting of stock options that were granted, over their vesting period.

LIQUIDITY AND CAPITAL RESOURCES

The Company reported a consolidated net loss and total comprehensive loss of $9,174,000 for the fiscal year ended July 31, 2020 (July 31, 2019-$7,526,000). As at July 31, 2020 the Company had working capital of $2,735,000, shareholders’ equity of $2,981,000, a deficit of $180,516,000. As at July 31, 2019 the Company had a working capital deficiency of $3,534,000, shareholders’ deficiency of $3,281,000 and a deficit of $171,531,000. The Company experienced a working capital deficiency throughout fiscal 2018 and 2019 until August 21, 2019 when the Company closed the first of a series of private placements for total gross proceeds of approximately $16,000,000. A portion of the private placement financings included the total disposition of a 49.0% stake in HIO. On July 8, 2020 HIO completed a direct Series B private placement which resulted in a dilution of the Company’s holding in HIO down to 42.51% as at July 31, 2020 and subsequently on September 3, 2020, HIO closed a direct Series C private placement which further diluted the Company’s holding in HIO down to 29.89%.

On June 26, 2020, the Company announced the receipt of a non-binding offer from CAIAC, as designated trustee of an alternative investment fund to be established, to purchase the Company’s remaining shares in HIO. The transaction was initially expected to close no later than August 31, 2020 but has since been deferred to the end of October 30, 2020, subject to the satisfaction of certain conditions, including, but not limited to, the negotiation of binding documentation, the receipt of a minimum of PLN7,300,000 by CAIAC pursuant to a financing, and the receipt of all required regulatory approvals. As of the filing of this press release, the Company had not yet closed the transaction with CAIAC though both parties continue to work through the process to finalize and close the transaction. There can be no assurance that the closing of the divestment will occur on the terms set out herein or at all.

In addition, the Company has been in discussions, during the year, with various capital market firms, both in the U.S. and Canada, with the goal of raising additional sufficient capital ($15,000,000 to $20,000,000) in order to qualify for a NASDAQ listing and further advance the Company’s clinical development programs. T

he Company’s group cash reserves of $4,235,000 as at July 31, 2020 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 have assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with 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, primarily 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.