Second Quarter 2019 Operational and Financial Results
Helix BioPharma Corp. (TSX:HBP.TO) (OTC:HBPCF) reported second quarter 2020 results and submitted its SEDAR filings on March 16, 2020. The second quarter, which spanned the November 1 to January 31 period, saw the launch of the L-DOS47 pancreatic trial, participation in several investor conferences, and the close of multiple private placements to funds its research and development activities.
Net loss for 2Q:20 was ($2.3) million1, an increase from the ($1.9) million loss in 2Q:19. On a per share basis this was ($0.02). Research and development expense was $1.6 million, up 19% from prior year levels due to greater expenditures on L-DOS47 including the launch of the pancreatic cancer study, and additional manufacturing costs for procuring additional drug product. Higher trademark and patent costs were also a contributor; however, there was no spend on the CAR-T program this year as there was in the prior period. General and administrative expenses were $654,000, rising 23% on increased expenditures for third party advisors and stock based compensation partially offset by lower wages and benefits.
As of January 31, 2020, the cash balance was $2.1 million compared to $0.2 million as of the end of the fiscal year, July 31, 2019. Cash burn in the second quarter was ($2.1) million, below prior year levels of ($2.4) million. Following the end of the reporting period, Helix raised an additional 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. A combination chemotherapy trial for European and Asian markets and a monotherapy trial which has completed data collection and is now finalizing reports for non-small cell lung cancer (NSCLC). A Phase Ib/II pancreatic cancer trial was recently launched that is expected to read out in 2021. This latter trial, which is being conducted in Scottsdale, Arizona has two actively enrolled patients in the study. Two other patients had also been enrolled, however, prior to starting the experimental treatment, they no longer qualified for the trial and withdrew from the study.
Helix recently contracted with a manufacturing organization to produce additional volumes of L-DOS47 for use in ongoing trials. Additional drug product is expected by the end of the summer. The product has already been manufactured and the polishing and fill and finish steps are now taking place. During the second quarter, approximately $295,000 was spent in this effort.
Helix’ pancreatic cancer trial, LDOS006, was launched in December and now has two enrollees in the Phase Ib portion of the study. 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 is working on finalizing data for reporting. An abstract for trial outcomes has been submitted for presentation at American Society of Clinical Oncology (ASCO) conference this year. A clinical study report is expected by 1Q:20.
Exhibit I – Product Development Pipeline2
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 under review – Calendar 1Q:20
‣ Availability of additional supply of L-DOS47 – 2H:20
‣ Advancement of LDOS003 to Part II – Dependent on partnership
‣ Anticipated completion of LDOS006 – year-end 2021
Helix is focused on modulating the acidic tumor microenvironment through the use of an antibody protein conjugate which links a epitope-specific antibody to a urease enzyme. The urease enzyme is able to catalyze extracellular urea into inert carbon dioxide and basic ammonia which raises the pH of the tumor microenvironment. The ammonia is toxic to cancer cells and also creates an environment that allows weak-base chemotherapies to come in closer contact with target cancer cells. Helix is currently pursuing indications in combination with chemotherapy for non-small cell lung carcinoma (NSCLC) and pancreatic cancer. There may be future opportunities for combination work with checkpoint inhibitors. Below we summarize the key elements supporting our favorable investment thesis. Refer to our initiation report for a details discussion of the company.
Key reasons to own Helix shares:
‣ Novel mechanism of action that is synergistic with other therapies
‣ CEACAM6 target is specific to tumor cells, especially lung and pancreatic adenocarcinoma
‣ L-DOS47 may reverse acidic extra-cellular conditions favorable to cancer cell survival
‣ L-DOS47 may improve uptake of weak-base chemotherapeutics
‣ L-DOS47 may reduce PD-1 and PD-L1 expression thereby improving immune response
‣ Favorable drug safety profile with no reported drug-related adverse events
‣ Biologic eligible for 12 years of exclusivity in United States and extended protection in other geographies
‣ North American rights to intellectual property
‣ Pursuing multiple indications
◦ Non small cell lung cancer
◦ Pancreatic cancer
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1. Share prices, value references in the text and financial statement items are denominated in Canadian dollars.
2. Source: Helix Biopharma February 2020 Corporate Presentation.