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8th August 2019
Conference call to be held on August 8, 2019 at 8:30 am EDT/1:30 pm BST -
LONDON, August 8, 2019 -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its financial and operational results for the second quarter ended June 30, 2019.
Operational Highlights:
Pipeline Updates and Anticipated Milestones:
“This quarter we have focused on expanding operations at our clinical manufacturing site at the Catapult Cell and Gene facility in Stevenage, UK, enabling us to meet our expected clinical trial demand, including a registration trial with AUTO1. In April, we presented encouraging data on our ALLCAR19 clinical trial of AUTO1 in adult ALL. These data show that AUTO1 is well differentiated from the standard of care in ALL and other CAR T products in development, reaching a high level of clinical activity without inducing severe cytokine release syndrome. For the remainder of 2019, our efforts are focused on moving AUTO1 into a Phase 2 registration trial in adult ALL and advancing AUTO3 in DLBCL toward a Phase 2 decision point in Q2 2020.”
Dr. Christian Itin, chairman and chief executive officer of Autolus
Financial results for second quarter 2019:
Conference Call and Presentation Information
Autolus management will host a conference call today, August 8, at 8:30 a.m. EDT/ 1:30pm BST, 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 2763978. 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 2763978.
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 Statement
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.
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Autolus Therapeutics PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three months ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Grant income | $ | 338 | $ | 443 | $ | 2,302 | $ | 869 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | (26,173 | ) | (8,863 | ) | (48,738 | ) | (20,490 | ) | ||||||||
General and administrative | (11,370 | ) | (8,103 | ) | (20,926 | ) | (12,433 | ) | ||||||||
Total operating expenses, net | (37,205 | ) | (16,523 | ) | (67,362 | ) | (32,054 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,074 | 266 | 1,615 | 555 | ||||||||||||
Other income | 4,380 | 6,390 | 3,396 | 3,449 | ||||||||||||
Total other income, net | 5,454 | 6,656 | 5,011 | 4,004 | ||||||||||||
Net loss before income tax | (31,751 | ) | (9,867 | ) | (62,351 | ) | (28,050 | ) | ||||||||
Income tax benefit | 3,274 | 2,217 | 6,696 | 3,683 | ||||||||||||
Net loss attributable to ordinary shareholders | (28,477 | ) | (7,650 | ) | (55,655 | ) | (24,367 | ) | ||||||||
Other comprehensive income: | ||||||||||||||||
Foreign currency exchange translation adjustment | (8,872 | ) | (11,206 | ) | (3,821 | ) | (6,242 | ) | ||||||||
Total comprehensive loss | $ | (37,349 | ) | $ | (18,856 | ) | $ | (59,476 | ) | $ | (30,609 | ) | ||||
Basic and diluted net loss per ordinary share | $ | (0.65 | ) | $ | (0.26 | ) | $ | (1.34 | ) | $ | (0.84 | ) | ||||
Weighted-average basic and diluted ordinary shares | 43,611,531 | 29,386,128 | 41,552,718 | 29,111,323 |
Autolus Therapeutics PLC
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, | December 31, | ||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 266,194 | $ | 217,450 | |||
Restricted cash | 683 | 105 | |||||
Prepaid expenses and other current assets | 25,831 | 15,411 | |||||
Total current assets | 292,708 | 232,966 | |||||
Non-current assets: | |||||||
Property and equipment, net | 25,967 | 19,968 | |||||
Right of use asset, net | 25,505 | — | |||||
Long-term deposits | 1,965 | 1,276 | |||||
Total assets | $ | 346,145 | $ | 254,210 | |||
Liabilities and shareholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | 3,143 | 2,022 | |||||
Accrued expenses and other liabilities | 17,237 | 19,054 | |||||
Lease liability | 1,925 | — | |||||
Total current liabilities | 22,305 | 21,076 | |||||
Non-current liabilities: | |||||||
Lease liability | 25,497 | — | |||||
Long-term lease incentive obligation | — | 207 | |||||
Other long-term payables | 121 | 285 | |||||
Total liabilities | 47,923 | 21,568 | |||||
Shareholders' equity: | |||||||
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 44,981,860 and 40,145,617, shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 2 | 2 | |||||
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at June 30, 2019 and December 31, 2018 | — | — | |||||
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at June 30, 2019 and December 31, 2018 | 118 | 118 | |||||
Deferred C shares, £0.000001 par value; 1 share authorized, issued and outstanding at June 30, 2019 and December 31, 2018 | — | — | |||||
Additional paid-in capital | 486,369 | 361,311 | |||||
Accumulated other comprehensive loss | (19,309 | ) | (15,488 | ) | |||
Accumulated deficit | (168,958 | ) | (113,301 | ) | |||
Total shareholders' equity | 298,222 | 232,642 | |||||
Total liabilities and shareholders' equity | $ | 346,145 | $ | 254,210 |