Autolus Therapeutics Reports Third Quarter 2020 Financial Results and Operational Progress
“We have made steady progress in the third quarter and continued to enroll in our AUTO3 ALEXANDER outpatient cohort, as well as our
Pipeline Updates:
- Data presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from our recommended Phase 2 dose cohort from the ALEXANDER trial of AUTO3, a CD19 and CD22 dual targeting CAR T product candidate in relapsed/refractory diffuse large B cell lymphoma (DLBCL).
- Data on both
AUTO1 and AUTO3 will be presented in oral presentations at theAmerican Society of Hematology (ASH) inDecember 2020
°AUTO1 in adult Acute Lymphoblastic Leukemia (ALL) - longer term follow up
° AUTO3 in DLBCL - updated data and longer term follow up from ALEXANDER study.
- Plans to progress the solid tumor programs, AUTO6NG in GD2 positive tumors and AUTO7 in prostate cancer, into the clinic in 2021.
Key Upcoming Clinical Milestones:
- Clinical updates for AUTO1 in adult ALL (ALLCAR study) at ASH in
December 2020 . - Clinical update for AUTO3 in DLBCL (ALEXANDER study) at ASH.
- Initiation of Phase 1 study for
AUTO1 /22 in pediatric ALL in Q4 2020. - Phase 1 interim data for AUTO4 in T cell lymphoma in 2021.
- Initiation of Phase 1 studies for AUTO6NG and AUTO7 in solid tumors in 2021.
- First exploratory allogeneic program expected to enter the clinic in Q1 2021.
Financial results for third quarter 2020
Cash and equivalents at September 30, 2020 totaled $177.7 million, compared with $212.0 million at June 30, 2020.
Net total operating expenses for the three months ended September 30, 2020 were $42.7 million, net of grant income of $0.4 million and license revenue of
Research and development expenses increased to
Non-cash costs decreased to
General and administrative expenses increased to
Non-cash costs decreased to
Interest income decreased by
Other (expense)/ income decreased by
Income tax benefit increased to
Net loss attributable to ordinary shareholders was $37.3 million for the three months ended September 30, 2020, compared to $27.2 million for the same period in 2019.
The basic and diluted net loss per ordinary share for the three months ended September 30, 2020 totaled $(0.72), compared to a basic and diluted net loss per ordinary share of $(0.61) for the three months ended September 30, 2019.
The Company anticipates that cash on hand is sufficient to fund operations into 2022.
Conference Call and Presentation Information
Management will host a conference call and webcast at 8:30 am ET/
The call may also be accessed by dialing (866) 679-5407 for
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of AUTO3 and the future clinical development of AUTO3 including progress, expectations as to the reporting of data, conduct and timing. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in
Contact:
Vice President, Investor Relations and Corporate Communications
+44 (0) 7587 372 619
l.crabtree@autolus.com
+44 (0) 7818 430877
j.wilson@autolus.com
+1-212-966-3650
susan@sanoonan.com
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended |
Nine Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Grant income | $ | 438 | $ | 297 | $ | 1,069 | $ | 2,599 | |||||||
License revenue | 242 | — | 242 | — | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | (33,545 | ) | (27,310 | ) | (96,160 | ) | (76,050 | ) | |||||||
General and administrative | (9,843 | ) | (8,605 | ) | (25,966 | ) | (29,531 | ) | |||||||
Total operating expenses, net | (42,708 | ) | (35,618 | ) | (120,815 | ) | (102,982 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 37 | 509 | 500 | 2,124 | |||||||||||
Other (expense) income | (2,509 | ) | 3,263 | 2,500 | 6,659 | ||||||||||
Total other (expense) income, net | (2,472 | ) | 3,772 | 3,000 | 8,783 | ||||||||||
Net loss before income tax | (45,180 | ) | (31,846 | ) | (117,815 | ) | (94,199 | ) | |||||||
Income tax benefit | 7,865 | 4,598 | 18,582 | 11,294 | |||||||||||
Net loss attributable to ordinary shareholders | (37,315 | ) | (27,248 | ) | (99,233 | ) | (82,905 | ) | |||||||
Other comprehensive (loss) income: | |||||||||||||||
Foreign currency exchange translation adjustment | 10,915 | (9,044 | ) | (8,605 | ) | (12,865 | ) | ||||||||
Total comprehensive loss | $ | (26,400 | ) | $ | (36,292 | ) | $ | (107,838 | ) | (95,770 | ) | ||||
Basic and diluted net loss per ordinary share | $ | (0.72 | ) | $ | (0.61 | ) | $ | (1.93 | ) | $ | (1.95 | ) | |||
Weighted-average basic and diluted ordinary shares | 52,093,826 | 44,505,383 | 51,339,662 | 42,547,755 | |||||||||||
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
Assets | |||||||
Current assets: | |||||||
Cash | $ | 177,695 | $ | 210,643 | |||
Restricted cash | 786 | 787 | |||||
Prepaid expenses and other assets, current | 50,388 | 37,826 | |||||
Total current assets | 228,869 | 249,256 | |||||
Non-current assets: | |||||||
Property and equipment, net | 32,755 | 28,164 | |||||
Right of use assets, net | 49,535 | 23,409 | |||||
Long-term deposits | 2,446 | 2,040 | |||||
Prepaid expenses and other assets, non-current | 2,890 | — | |||||
Deferred tax asset | 410 | 410 | |||||
Intangible assets, net | 172 | 254 | |||||
Total assets | $ | 317,077 | $ | 303,533 | |||
Liabilities and shareholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | 1,997 | 1,075 | |||||
Accrued expenses and other liabilities | 25,400 | 21,398 | |||||
Lease liabilities | 3,413 | 2,511 | |||||
Total current liabilities | 30,810 | 24,984 | |||||
Non-current liabilities: | |||||||
Lease liabilities | 49,456 | 23,710 | |||||
Total liabilities | 80,266 | 48,694 | |||||
Shareholders' equity: | |||||||
Ordinary shares, |
3 | 2 | |||||
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at |
— | — | |||||
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at |
118 | 118 | |||||
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at |
— | — | |||||
Additional paid-in capital | 590,369 | 500,560 | |||||
Accumulated other comprehensive loss | (17,296 | ) | (8,691 | ) | |||
Accumulated deficit | (336,383 | ) | (237,150 | ) | |||
Total shareholders' equity | 236,811 | 254,839 | |||||
Total liabilities and shareholders' equity | $ | 317,077 | $ | 303,533 |
Source: Autolus Therapeutics plc