Autolus Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Operational Progress
- Conference call to be held on
“It has been an exciting year of progress for
Key Pipeline Updates:
AUTO1 in adult lymphocytic leukemia (ALL). Data presented at theAmerican Society of Hematology (ASH) demonstrated thatAUTO1 , a novel fast off CD19 CAR, was well-tolerated with a high level of clinical activity. As of the most recent cut-off date ofNovember 25, 2019 , of the 15 patients evaluable for efficacy, 13 patients (87%) achieved minimal residual disease, or MRD, negative complete responses at one month and all patients had ongoing CAR T cell persistence at last follow-up. 10 of the 15 evaluable patients (67%) remain disease-free at a median follow up of 11 months (range of 0.5 month - 21 months). Of the 16 patients dosed, ten patients were dosed withAUTO1 manufactured using our semi-automated, fully enclosed system for manufacturing. In this cohort, nine patients were evaluable and achieved MRD negative complete responses of 100%. The median follow-up in this cohort was 6.7 months (range of 1.1 month-14.5 months). The event free survival or EFS and overall survival or OS data are preliminary considering the small number of patients.
InOctober 2019 theU.S. Food and Drug Administration , or FDA, granted orphan drug designation forAUTO1 for the treatment of ALL.
- AUTO3 in Diffuse large B-cell lymphoma (DLBCL). Data were presented at ASH with an update provided in a keynote lecture at EHA-EBMT 2nd European CAR T Cell Meeting. These data support the encouraging early indications of durability and high level of activity previously reported and show the potential for a differentiated product profile. As of the data cut-off date of January 21, 2020 (data availability as of January 28, 2020), 18 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 were evaluable for safety and efficacy with minimum 28-day follow-up. In the cohorts dosed at 450 x 106 AUTO3 cells plus pembrolizumab, five out of seven patients (ORR=71%) achieved a response (complete response + partial response) and four out of seven patients (CRR=57%) achieved a complete response. Across all dose levels, seven out of eight complete responders (87%) had ongoing complete responses at a median follow up of six months (range of one month - 18 months). All seven out of seven complete responders (100%) treated with AUTO3 and pembrolizumab have ongoing complete responses as of January 21, 2020 at a median follow up of three months (range of one month - 18 months). AUTO3 was generally well tolerated, with no patients experiencing dose limiting toxicity, and there were no treatment-related deaths. Notably, none of the patients treated in the higher dose cohorts experienced any high grade CRS or any neurotoxic events of any grade, which may provide AUTO3 with a safety profile suitable for the outpatient setting, and allow for a significant expansion of the market opportunity compared to CAR T therapies currently approved for DLBCL.
- AUTO6NG in neuroblastoma. Pre-clinical data presented at the
Society for Immunotherapy of Cancer (SITC) from the Company’s next generation GD2-targeting CAR T cell therapy, demonstrates the utility of three modules added to the clinically active and validated AUTO6 GD-2 targeting CAR that not only improve CAR T persistence but also combat the immunosuppressive tumor microenvironment.
Operational and Corporate Highlights:
- Completed public offerings in
April 2019 andJanuary 2020 raising net proceeds of approx.$184 million .
- Presented clinical data on our lead programs
AUTO1 and AUTO3 in four oral presentations at AnnualAmerican Society of Hematology (ASH) conference inDecember 2019 .
- Presented non-clinical data for our most advanced next generation solid tumor program AUTO6NG at the annual meeting of the
Society for Immunotherapy Conference (SITC) inNovember 2019 , highlighting a suite of activity enhancing programming modules built into the clinically active AUTO6 program.
- Licensed the PRIME (proliferation-inducing and migration-enhancing) technology from
Noile-Immune Biotech, Inc. inNovember 2019 , which can provide our next-generation solid tumor CAR T programs the ability to activate the patient’s immune system against the cancer cells.
- Initiated manufacturing at the Cell and Gene Therapy Catapult site in
Stevenage, UK , inMarch 2019 , and delivering clinical products for patients in bothEurope and the US.
Key Upcoming Clinical Milestones:
- Initiation of the pivotal program of
AUTO1 in adult ALL on track – dosing of first patients in the first half of 2020.
- Go/no go decision on Phase 2 initiation of AUTO3 in DLBCL expected in mid-2020.
- Interim Phase 1 data in T cell lymphoma with AUTO4 in the second half of 2020.
- Report data from multiple clinical and pre-clinical programs at key medical conferences throughout the year and progress additional next generation programs through pre-clinical into clinical development.
- Expansion of the Company’s suite of cell programming technologies to include programming modules designed for allogeneic applications, with the first novel allogeneic program expected to enter the clinic in the fourth quarter of 2020.
Financial Results for the Quarter and Year Ended
Cash and equivalents at
Net total operating expenses for the twelve months ended
Research and development expenses increased to
General and administrative expenses increased to
Net loss attributable to ordinary shareholders was
The basic and diluted net loss per ordinary share for the twelve months ended
Conference Call and Presentation Information
To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-and-events/events.
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 Autolus’ financial condition and results of operations, including its expected cash runway; the development of Autolus’ product candidates, including statements regarding the timing of initiation, completion and the outcome of pre-clinical studies or clinical trials and related preparatory work, and the periods during which the results of the studies and trials will become available; Autolus’ plans to research, develop, manufacture and commercialize its product candidates; the potential for Autolus’ product candidates to be alternatives in the therapeutic areas investigated; and Autolus’ manufacturing capabilities and strategy. 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. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our 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
| Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) |
||||||||
| (unaudited) | ||||||||
| 2019 | 2018 | |||||||
| Grant income | $ | 2,908 | $ | 1,472 | ||||
| Gain on disposal | ||||||||
| Operating expenses: | ||||||||
| Research and development | (105,418 | ) | (48,299 | ) | ||||
| General and administrative | (39,452 | ) | (27,299 | ) | ||||
| Loss on impairment of leasehold improvements | (4,102 | ) | - | |||||
| Total operating expenses, net | (146,064 | ) | (74,126 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 2,542 | 2,011 | ||||||
| Other Income / (expense) | 4,514 | 5,752 | ||||||
| Total other income (expense), net | 7,056 | 7,763 | ||||||
| Net loss before income tax | (139,008 | ) | (66,363 | ) | ||||
| Income tax benefit | 15,159 | 8,488 | ||||||
| Net loss attributable to ordinary shareholders | $ | (123,849 | ) | $ | (57,875 | ) | ||
| Basic and diluted net loss per ordinary share | $ | (2.88 | ) | $ | (1.48 | ) | ||
| Weighted-average basic and diluted ordinary shares |
43,065,542 | 39,163,413 | ||||||
| Consolidated Balance Sheets (In thousands, except share and per share amounts) |
||||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 210,643 | $ | 217,450 | ||||
| Restricted cash | 787 | 105 | ||||||
| Prepaid expenses and other current assets | 37,826 | 15,411 | ||||||
| Total current assets | 249,256 | 232,966 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | 28,164 | 19,968 | ||||||
| Right of use asset, net | 23,409 | — | ||||||
| Long-term deposits | 2,040 | 1,276 | ||||||
| Deferred tax asset | 410 | — | ||||||
| Intangible assets, net | 254 | — | ||||||
| Total assets | $ | 303,533 | $ | 254,210 | ||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 1,075 | 2,022 | ||||||
| Accrued expenses and other liabilities | 21,398 | 19,054 | ||||||
| Lease liability | 2,511 | — | ||||||
| Total current liabilities | 24,984 | 21,076 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability | 23,710 | — | ||||||
| Long-term lease incentive obligation | — | 207 | ||||||
| Other long-term payables | — | 285 | ||||||
| Total liabilities | 48,694 | 21,568 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, 2019 and 2018, 44,983,006 and 40,145,617 shares issued and outstanding at December 31, 2019 and 2018 |
2 | 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 | 500,560 | 361,311 | ||||||
| Accumulated other comprehensive loss | (8,691 | ) | (15,488 | ) | ||||
| Accumulated deficit | (237,150 | ) | (113,301 | ) | ||||
| Total shareholders' equity | 254,839 | 232,642 | ||||||
| Total liabilities and shareholders' equity |
$ | 303,533 | $ | 254,210 | ||||
Source: Autolus Therapeutics plc