Autolus Therapeutics Reports Third Quarter 2019 Financial Results and Operational Progress
“We are excited about the opportunity to share data updates at ASH on AUTO1 in ALL in three oral presentations, as well as an oral presentation on AUTO3 in DLBCL. We are also looking forward to presenting data on our other hematological clinical programs at ASH, and non-clinical data on our lead solid tumor program AUTO6NG at SITC,” stated Dr.
Pipeline Updates:
- On
November 5 , theUnited States Food and Drug Administration granted orphan drug designation for AUTO1 for the treatment of acute lymphoblastic leukemia (ALL).
- SITC Meeting Presentation
Solid tumors (AUTO6NG) - AUTO6NG: Next generation GD2-targeting CAR T-cell therapy with improved persistence and insensitivity to TGFb and checkpoint inhibition for relapsed/refractory neuroblastoma (Saturday November 9 , poster presentation) - ASH Meeting Presentations
Adult ALL (AUTO1) - AUTO1, a novel fast off CD19 CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Saturday December 7 , oral presentation)
Pediatric ALL (AUTO1) - Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Saturday December 7 , oral presentation)
Integration Site Analysis (AUTO1) - Clonal dynamics of early responder and long-term persisting CAR-T cells in humans (Saturday December 7 , oral presentation)
DLBCL (AUTO3) - Phase 1/2 study of AUTO3 the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of Cohort 1 and 2 of the ALEXANDER study (Saturday December 7 , oral presentation)
Multiple Myeloma (AUTO2) - Phase 1 First-in-Human study of AUTO2, the first chimeric antigen receptor (CAR) T cell targeting APRIL for patients with relapsed/refractory Multiple Myeloma (RRMM) (Sunday December 8 , poster presentation)
Pediatric ALL (AUTO3) - Phase 1 Study of AUTO3, a Bicistronic Chimeric Antigen Receptor (CAR) T-cell Therapy Targeting of CD19 and CD22, in Pediatric Patients with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL): AMELIA Study (Sunday December 8 , poster presentation)
Operational and Corporate Highlights:
- Manufacturing update
The Cell and Gene Therapy Catapult site is fully operational and is delivering clinical products for patients in bothEurope and the US - Significant change in shareholder base
In September,PPF Group announced that they had acquired, mainly fromWoodford Investment Management , an approximate 19% holding of Autolus. Control of all the remaining shares of Autolus held byWoodford Investment Management are in the process of being transferred toSchroder UK Public Private Trust plc . - Nature Medicine publication of AUTO1 CARPALL study in pediatric ALL
In September, Autolus announced that the journal Nature Medicine has published both pre-clinical results and clinical data from the ongoing Phase 1 CARPALL trial of AUTO1, demonstrating the potential of the company’s novel CAR T therapy targeting CD19 in development for the treatment of pediatric acute lymphoblastic leukemia (ALL). - Executive Leadership Team Changes
David Brochu has been named Senior Vice President, Head of Product Delivery to lead the transition of the company’s manufacturing organization to deliver products for late-stage clinical studies and commercial sale. In addition,Vishal Mehta has been named Vice President, Head of Clinical Operations.
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
Financial results for third quarter 2019
Cash and equivalents at
Net total operating expenses for the three 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 three months ended
Autolus anticipates that cash on hand provides a runway into the second half of 2021.
Conference Call and Presentation Information
Autolus management will host a conference call today,
To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-events/events.
The call may also be accessed by dialing (866) 679-5407 for U.S. and
About
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit www.autolus.com.
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, as well as statements regarding the anticipated development of Autolus’ product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. 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 Autolus' Annual Report on Form 20-F filed on
Investor and media contact:
Vice President,
Autolus
+1-240-801-3850
s.taylor@autolus.com
+44 (0) 7818 430877
j.wilson@autolus.com
Autolus Therapeutics PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||
Grant income | $ | 297 | $ | 307 | $ | 2,599 | $ | 1,176 | ||||
Operating expenses: | ||||||||||||
Research and development | (27,310) | (10,096) | (76,050) | (30,586) | ||||||||
General and administrative | (8,605) | (7,273) | (29,531) | (19,706) | ||||||||
Total operating expenses, net | (35,618) | (17,062) | (102,982) | (49,116) | ||||||||
Other income (expense): | ||||||||||||
Interest income | 509 | 796 | 2,124 | 1,351 | ||||||||
Other income | 3,263 | 1,206 | 6,659 | 4,655 | ||||||||
Total other income, net | 3,772 | 2,002 | 8,783 | 6,006 | ||||||||
Net loss before income tax | (31,846) | (15,060) | (94,199) | (43,110) | ||||||||
Income tax benefit | 4,598 | 2,200 | 11,294 | 5,883 | ||||||||
Net loss attributable to ordinary shareholders | (27,248) | (12,860) | (82,905) | (37,227) | ||||||||
Other comprehensive loss: | ||||||||||||
Foreign currency exchange translation adjustment | (9,044) | (973) | (12,865) | (7,215) | ||||||||
Total comprehensive loss | $ | (36,292) | $ | (13,833) | $ | (95,770) | $ | (44,442) | ||||
Basic and diluted net loss per ordinary share | $ | (0.61) | $ | (0.33) | $ | (1.95) | $ | (1.14) | ||||
Weighted-average basic and diluted ordinary shares |
44,505,383 | 39,214,334 | 42,547,755 | 32,516,001 |
Autolus Therapeutics PLC
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
September 30, 2019 |
December 31, 2018 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 229,366 | $ | 217,450 | |||
Restricted cash | 681 | 105 | |||||
Prepaid expenses and other current assets | 30,136 | 15,411 | |||||
Total current assets | 260,183 | 232,966 | |||||
Non-current assets: | |||||||
Property and equipment, net | 28,413 | 19,968 | |||||
Right of use asset, net | 24,133 | — | |||||
Long-term deposits | 1,912 | 1,276 | |||||
Total assets | $ | 314,641 | $ | 254,210 | |||
Liabilities and shareholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | 2,733 | 2,022 | |||||
Accrued expenses and other liabilities | 15,548 | 19,054 | |||||
Lease liability | 2,282 | — | |||||
Total current liabilities | 20,563 | 21,076 | |||||
Non-current liabilities: | |||||||
Lease liability | 24,407 | — | |||||
Long-term lease incentive obligation | — | 207 | |||||
Other long-term payables | 30 | 285 | |||||
Total liabilities | 45,000 | 21,568 | |||||
Shareholders' equity: | |||||||
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 44,982,378 and 40,145,617, shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
2 | 2 | |||||
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2019 and December 31, 2018 |
— | — | |||||
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2019 and December 31, 2018 |
118 | 118 | |||||
Deferred C shares, £0.000001 par value; 1 share authorized, issued and outstanding at September 30, 2019 and December 31, 2018 |
— | — | |||||
Additional paid-in capital | 494,080 | 361,311 | |||||
Accumulated other comprehensive loss | (28,353 | ) | (15,488 | ) | |||
Accumulated deficit | (196,206 | ) | (113,301 | ) | |||
Total shareholders' equity | 269,641 | 232,642 | |||||
Total liabilities and shareholders' equity | $ | 314,641 | $ | 254,210 |
Source: Autolus Therapeutics plc