LONDON, Nov. 07, 2019 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2019.
“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. Christian Itin, chairman and chief executive officer of Autolus. “This quarter we have made significant operational progress, delivering cell products from our new manufacturing operations at the Cell and Gene Therapy Catapult and further strengthening our management team. Supported by a strong balance sheet, our key focus is on moving AUTO1 into our first pivotal clinical program in adult patients with ALL.”
Pipeline Updates:
Operational and Corporate Highlights:
Key Upcoming Clinical Milestones:
Financial results for third quarter 2019
Cash and equivalents at September 30, 2019 totaled $229.4 million, compared with $247.1 million at September 30, 2018.
Net total operating expenses for the three months ended September 30, 2019 were $35.6 million, net of grant income of $0.3 million, as compared to net operating expenses of $17.1 million, net of grant income of $0.3 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 $27.3 million for the three months ended September 30, 2019 from $10.1 million for the three months ended September 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $21.6 million from $9.0 million. The increase in research and development cash costs of $12.6 million consisted primarily of an increase of compensation-related costs of $5.2 million primarily due to an increase in employee headcount to support the advancement of our product candidates in clinical development, an increase of $3.6 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, including the manufacturing technical transfer activities required for AUTO1 to enable the commencement at the end of 2019 of a registration study in Adult Acute Lymphoblastic Leukemia, an increase of $2.6 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, an increase of $0.7 million in telecom and software costs, and an increase of $0.5 million in other costs.
General and administrative expenses increased to $8.6 million for the three months ended September 30, 2019 from $7.3 million for the three months ended September 30, 2018. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $5.6 million from $5.7 million. Compensation related expenses decreased by $0.6 million and IT, telecommunication, and general office expense costs decreased by $0.7 million which were offset by an increase in legal and professional fees of $0.9 million and an increase of $0.3 million in commercial costs.
Net loss attributable to ordinary shareholders was $27.2 million for the three months ended September 30, 2019, compared to $12.9 million for the same period in 2018.
The basic and diluted net loss per ordinary share for the three months ended September 30, 2019 totaled $(0.61) compared to a basic and diluted net loss per ordinary share of $(0.33) for the three months ended September 30, 2018.
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, November 7, at 8:30 a.m. EST/ 1:30pm GMT, to discuss the company’s financial results and operational update.
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 Canada callers or (409) 217-8320 for international callers. Please reference conference ID 5075598. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 5075598.
About Autolus Therapeutics plc
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 November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
Investor and media contact:
Silvia Taylor
Vice President, Corporate Affairs and Communications
Autolus
+1-240-801-3850
s.taylor@autolus.com
UK:
Julia Wilson
+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 |