3rd March 2020
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LONDON, March 3, 2020 -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the fourth quarter and full year ended December 31, 2019.
“It has been an exciting year of progress for Autolus concluding with the presentation of encouraging AUTO 1 and AUTO 3 clinical data at the ASH conference in December 2019. AUTO1 is poised for a pivotal Phase 2 clinical trial starting in the first half of 2020, and AUTO3 is progressing to a Phase 2 decision point in mid-2020. Supported by a strong balance sheet and alongside the two lead programs, we also continue to advance our next generation programs towards key near-term value inflection points.”
Dr. Christian Itin, Chairman and Chief Executive Officer of Autolus
Key Pipeline Updates:
In October 2019 the U.S. Food and Drug Administration, or FDA, granted orphan drug designation for AUTO1 for the treatment of ALL.
Operational and Corporate Highlights:
Key Upcoming Clinical Milestones:
Financial Results for the Quarter and Year Ended December 31, 2019
Cash and equivalents at December 31, 2019 totaled $210.6 million, before adjusting for the public offering in January 2020 of approximately $75 million net. This compared to $217.5 million at December 31, 2018.
Net total operating expenses for the twelve months ended December 31, 2019 were $146.1 million, net of grant income of $2.9 million, as compared to net operating expenses of $74.1 million, net of grant income of $1.5 million, for the same period in 2018. The increase was due, in general, to the increase in development activity, increased headcount primarily in our development and manufacturing functions, and the cost of being a public company.
Research and development expenses increased to $105.4 million for the year ended December 31, 2019 from $48.3 million for the year ended December 31, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $83.4 million from $41.5 million. The increase in research and development cash costs of $41.9 million consisted of an increase in compensation-related costs of $20.0 million, primarily due to an increase in headcount to support the advancement of our product candidates in clinical development and investment in manufacturing facilities and equipment, an increase of $4.1 million in research and manufacturing consumables, in part due to the migration and expansion of our research and process development laboratories from Forest House to our new location in the Media Works facility, preparations in advance of any potential disruption to supply arrangements that may occur due to Brexit, as well as validation and training costs as part of the start-up at the Catapult facility, an increase of $10.2 million in facility costs primarily related to the addition of Media Works and Catapult, an increase of $3.8 million in project expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, an increase of $1.5 million in consulting, contracting and license fees that includes a decrease in milestone payments of $0.5 million consisting of a milestone payable to UCL Business plc in 2018 and a milestone payable to Noile-Immune Biotech Inc. in 2019, and an increase in IT and general office expenses of $2.3 million.
General and administrative expenses increased to $39.5 million for the year ended December 31, 2019 from $27.3 million for the year ended December 31, 2018. Cash costs, which exclude depreciation as well as share-based compensation increased to $26.6 million from $21.4 million. The increase of $5.2 million consisted primarily of an increase in compensation-related costs of $2.6 million due to an overall increase in headcount, an increase of $1.9 million in commercial costs, an increase in public company compliance costs of $1.0 million, an increase of $0.7 million in facility costs related to lease and maintenance costs, offset by decrease of $1.0 million in IT charges, project expenses, and other office expenses.
Net loss attributable to ordinary shareholders was $123.8 million for the twelve months ended December 31, 2019, compared to $57.9 million for the same period in 2018.
The basic and diluted net loss per ordinary share for the twelve months ended December 31, 2019 totaled $(2.88) compared to a basic and diluted net loss per ordinary share of $(1.48) for the twelve months ended December 31, 2018.
Autolus anticipates that cash on hand provides a runway into 2022.