Third Quarter 2019 Operational and Financial Results
Helix BioPharma Corp. (TSX: HBP.TO) (OTC: HBPCF) reported third quarter 2020 results and submitted its SEDAR filings on July 30, 2020. During the third quarter, which ended April 30, 2020, Helix presented at the Noble Capital Markets conference, raised CAD$6 million in a private placement and updated investors on the impact of COVID-19 on operations. Following 3Q:20, the company announced the Phase I lung cancer data presentation at the American Society of Clinical Oncology (ASCO) conference, signaled that it will completely divest of its interest in its Polish subsidiary and entered into an agreement with CAIAC Fund Management to sell its remaining interest in it. Helix also participated in investor events, one of which we summarize in an article here1.
Net loss for 3Q:20 was ($2.6) million2, which compares with the ($2.1) million loss in 3Q:19. On a per share basis, this was ($0.02). Research and development expense was $1.5 million, up 13% from prior year levels due to expenditure on manufacturing of L-DOS47 for use in clinical trials and expenditure for the Phase Ib/II pancreatic trial. These amounts were partially offset by a reduction in spend related to the L-DOS001 study and lower spending related to the research collaboration with the Moffitt Cancer Center. General and administrative expenses were $862,000, rising 23% on increased expenditures for third party advisory services such as investor and media relations, legal, business development activities and investment banking services.
As of April 30, 2020, the cash balance was $5.0 million compared to $0.2 million at the end of the fiscal year, July 31, 2019. Cash burn in the third quarter was ($2.2) million, compared with prior year levels of ($1.2) million. During the fiscal third quarter, Helix raised CAD$6 million which will continue to fund operations and research and development activities. The company has no debt on its balance sheet.
Helix is sponsoring two active Phase II trials. These include a combination chemotherapy trial for European and Asian markets and a monotherapy trial which has completed data collection and the clinical study report as of June 2020 for non-small cell lung cancer (NSCLC). Phase Ib/II pancreatic cancer trial LDOS006 was recently launched that is expected to read out in 2021. LDOS006 is being conducted in Scottsdale, Arizona with five patients enrolled in the study. Two of the enrollees have successfully completed the cycles and only one patient remains to complete the first cohort. One patient is currently active in the safety evaluation portion. Due to delays anticipated from the COVID-19 pandemic, additional sites are being sought to advance the trial and new locations may be added.
Helix recently contracted with a manufacturing organization to produce additional volumes of L-DOS47 for use in ongoing trials. Additional supply is expected before the end of the year. The product has already been manufactured and the polishing and fill and finish steps are now taking place. During the third quarter, approximately $161,000 was spent in this effort.
On June 26, 2020 Helix announced that it would be divesting its remaining ownership in its Polish subsidiary, Helix Immuno-Oncology S.A. (HIO). At the time of the announcement, Helix held a 51% interest in the entity following the sale earlier in the year of a 15.5% ownership stake. HIO had been developing V-DOS47, an antibody protein conjugate that targets vascular endothelial growth factor 2 receptor (VEGFR2) expressed in many carcinomas and lymphomas. Following the end of the reporting period, Helix cancelled approximately $2.7 million in intercompany debt owed it by HIO and assets related to Biphasix and V-DOS47 were transferred back to Helix. An increase in share capital was approved for HIO, which allowed for 2.2 million shares to be issued raising gross proceeds of approximately 3 million Polish zloty. This action reduced Helix’ interest in HIO to 42.5%. The company also accepted a non-binding offer to purchase the remaining 42.5% for 6.7 million Polish zloty, equivalent to CAD$2.3 million. The transaction is scheduled to close on August 31, 2020 and is subject to several conditions.
Helix’ pancreatic cancer trial, LDOS006, was launched in December and now has enrolled five patients in the Phase Ib portion of the study with only one more patient necessary to complete enrollment in the first cohort. This trial is combining chemotherapy agent doxorubicin with L-DOS47 in a dose escalating study for pancreatic cancer patients who have already undergone prior lines of therapy. The Phase Ib portion is targeting 9 patients for the study and will progress to the 11-patient Phase II segment of the study.
The LDOS003 trial is also underway examining the benefit of L-DOS47 with a combination of vinorelbine and cisplatin for non-small cell lung cancer (NSCLC) patients. This trial has been on hold since 2018 due to a shortage of vinorelbine and as management awaits a partner to advance the work.
The LDOS001 trial is being conducted in the United States using L-DOS47 in combination with carboplatin and pemetrexed for NSCLC. Patient recruitment was closed mid-2019 and the trial has issued a clinical study report. An abstract for trial outcomes has been submitted for presentation at American Society of Clinical Oncology (ASCO) conference this year.
Product Development Pipeline3
Corporate Milestones: Updates
Below we list key milestones that have occurred in the last year and anticipated future events.
‣ IND clearance by FDA for LDOS006 – August 2019
‣ Launch of LDOS006 – December 2019
‣ $6.0 million capital raise – March 2020
‣ Divestiture of 15.5% of Helix Immuno-Oncology (HIO) – March 2020
‣ LDOS001 abstract submitted – Calendar 1Q:20
‣ LDOS002 clinical study report completed – June 2020
‣ Full divestiture of HIO – August 31, 2020
‣ Availability of additional supply of L-DOS47 – Fall / Winter 2020
‣ Advancement of LDOS003 to Part II – Dependent on partnership
‣ Anticipated completion of LDOS006 – year-end 2021
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2. Share prices, value references in the text and financial statement items are denominated in Canadian dollars.
3. Source: Helix Biopharma February 2020 Corporate Presentation.