LONDON, Aug. 06, 2020 (GLOBE NEWSWIRE) -- 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, 2020.
“We have had a busy second quarter with data updates across our portfolio at key medical and scientific conferences,” said Dr Christian Itin, chairman and chief executive officer of Autolus. “Both our later stage programs, AUTO1 and AUTO3, continue to show encouraging clinical activity with tolerable safety in adult patients with ALL and DLBCL, respectively, and we are excited by the potential for these product candidates to have differentiated profiles addressing indications with high unmet needs. We look forward to providing further updates in H2 2020, starting with AUTO3 ALEXANDER data at a mini oral session at ESMO in September.”
“At AACR we presented data across a number of next generation programs,” said Dr Martin Pule, chief scientific officer of Autolus. “These data demonstrate the strength of our binder discovery capabilities with highly selective targeting in AUTO5 for T Cell lymphoma, as well as the ability of our cell programming modules to address the hostile solid tumor microenvironment as shown for AUTO6NG and AUTO7 for small cell lung cancer and prostate cancer, respectively. We are excited to be progressing these next generation programs into Phase 1 in 2021.”
Pipeline Updates:
Operational Highlights:
Key Upcoming Clinical Milestones:
Financial Results for the Quarter Ended June 30, 2020
Cash and equivalents at June 30, 2020 totaled $212.0 million, compared with $243.3 million at March 31, 2020.
Net total operating expenses for the three months ended June 30, 2020 were $39.5 million, net of grant income of $0.3 million, as compared to net operating expenses of $37.2 million, net of grant income of $0.3 million, for the same period in 2019.
Research and development expenses increased to $31.3 million for the three months ended June 30, 2020 from $26.2 million for the three months ended June 30, 2019. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $26.5 million from $20.2 million. The increase in research and development cash costs of $6.3 million consisted primarily of (i) an increase in compensation and employment related costs, net of lower travel costs as a result of the ongoing pandemic, of $1.8 million due to an increase in employee headcount to support the advancement of our product candidates in clinical development, (ii) an increase of $3.0 million in project expenses as a consequence of the advancement of our clinical portfolio which includes research and process development and manufacturing activities necessary to prepare, activate, and monitor clinical trial programs, (iii) an increase of $1.3 million in facilities costs related to the commencement of a lease for an additional manufacturing suite and the continued scaling of operations in the manufacturing facility, and (iv) an increase in IT and telecoms, general office expense, and professional fees of $0.6 million, which is offset by a decrease in materials purchases of $0.4 million.
Non-cash costs decreased to $4.8 million for the three months ended June 30, 2020 from $6.0 million for the three months ended June 30, 2019. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $1.3 million as a result of a lower fair value of stock options recognized in the period, offset by a small increase in depreciation.
General and administrative expenses decreased to $8.5 million for the three months ended June 30, 2020 from $11.4 million for the three months ended June 30, 2019. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $6.7 million from $7.3 million. Compensation related expenses decreased by $0.1 million aided by lower travel costs as described above. Further there was a decrease of $0.7 million in commercial activities. These decreases were offset by an increase of $0.1 million in legal and professional fees.
Non-cash costs decreased to $1.8 million for the three months ended June 30, 2020 from $3.9 million for the three months ended June 30, 2019. The decrease is attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period.
Interest income decreased by $1.1 million for three months ended June 30, 2020 due to lower interest rates.
Other income decreased to $0.5 million for the three months ended June 30, 2020 from other income of $4.4 million for the three months ended June 30, 2019 primarily due to a decrease of the U.S. dollar exchange rate relative to the pound sterling during the three months ending June 30, 2020 as compared to the three months ended June 30, 2019.
Income tax benefit increased to $7.0 million for the three months ended June 30, 2020 from $3.3 million for the three months ended June 30, 2019 due to increased R&D expenses, which led to a higher effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the increase in the net credit was primarily attributable to an increase in our eligible research and development expenses.
Net loss attributable to ordinary shareholders was $32.0 million for the three months ended June 30, 2020, compared to $28.5 million for the same period in 2019.
The basic and diluted net loss per ordinary share for the three months ended June 30, 2020 totaled $(0.62) compared to a basic and diluted net loss per ordinary share of $(0.65) for the three months ended June 30, 2019.
The Company anticipates that cash on hand is sufficient to fund operations into 2022.
Conference Call and Presentation Information
Autolus management will host a conference call today, August 6, at 8:30 a.m. EDT/ 1:30pm BST, to discuss the company’s financial results and operational update.
To access the live and subsequent replay, as well as dial in information of this webcast and view the accompanying slide presentation, please register here.
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, including its expected cash runway; the development of Autolus’ product candidates, including statements regarding the timing of initiation, completion and the outcome of preclinical 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 Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 3, 2020, as amended, 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.
Contact:
Lucinda Crabtree, PhD
Vice President, Investor Relations and Corporate Communications
+44 (0) 7587 372 619
l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+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 June 30, | Six Months Ended June 30, | |||||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||||
Grant income | $ | 293 | $ | 338 | $ | 631 | $ | 2,302 | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | (31,328 | ) | (26,173 | ) | (62,615 | ) | (48,738 | ) | ||||||||||
General and administrative | (8,509 | ) | (11,370 | ) | (16,123 | ) | (20,926 | ) | ||||||||||
Total operating expenses, net | (39,544 | ) | (37,205 | ) | (78,107 | ) | (67,362 | ) | ||||||||||
Other income (expense): | ||||||||||||||||||
Interest (expense) income | (47 | ) | 1,073 | 463 | 1,615 | |||||||||||||
Other income | 525 | 4,380 | 5,009 | 3,396 | ||||||||||||||
Total other income, net | 478 | 5,453 | 5,472 | 5,011 | ||||||||||||||
Net loss before income tax | (39,066 | ) | (31,752 | ) | (72,635 | ) | (62,351 | ) | ||||||||||
Income tax benefit | 7,021 | 3,274 | 10,717 | 6,696 | ||||||||||||||
Net loss attributable to ordinary shareholders | (32,045 | ) | (28,478 | ) | (61,918 | ) | (55,655 | ) | ||||||||||
Other comprehensive (loss) income: | ||||||||||||||||||
Foreign currency exchange translation adjustment | (1,819 | ) | (8,872 | ) | (19,520 | ) | (3,821 | ) | ||||||||||
Total comprehensive loss | (33,864 | ) | (37,350 | ) | (81,438 | ) | (59,476 | ) | ||||||||||
Basic and diluted net loss per ordinary share | $ | (0.62 | ) | $ | (0.65 | ) | $ | (1.22 | ) | $ | (1.34 | ) | ||||||
Weighted-average basic and diluted ordinary shares | 52,041,340 | 43,611,531 | 50,956,566 | 41,552,718 |
Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except share and per share amounts) | ||||||||
June 30, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 212,044 | $ | 210,643 | ||||
Restricted cash | 786 | 787 | ||||||
Prepaid expenses and other assets, current | 35,901 | 37,826 | ||||||
Total current assets | 248,731 | 249,256 | ||||||
Non-current assets: | ||||||||
Property and equipment, net | 30,954 | 28,164 | ||||||
Right of use assets, net | 25,100 | 23,409 | ||||||
Long-term deposits | 2,354 | 2,040 | ||||||
Prepaid expenses and other assets, non-current | 2,813 | — | ||||||
Deferred tax asset | 410 | 410 | ||||||
Intangible assets, net | 186 | 254 | ||||||
Total assets | $ | 310,548 | $ | 303,533 | ||||
Liabilities and shareholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | 626 | 1,075 | ||||||
Accrued expenses and other liabilities | 22,753 | 21,398 | ||||||
Lease liabilities | 3,888 | 2,511 | ||||||
Total current liabilities | 27,267 | 24,984 | ||||||
Non-current liabilities: | ||||||||
Lease liabilities | 24,329 | 23,710 | ||||||
Total liabilities | 51,596 | 48,694 | ||||||
Shareholders' equity: | ||||||||
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 52,250,404 and 44,983,006, shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 3 | 2 | ||||||
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at June 30, 2020 and December 31, 2019 | — | — | ||||||
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at June 30, 2020 and December 31, 2019 | 118 | 118 | ||||||
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at June 30, 2020 and December 31, 2019 | — | — | ||||||
Additional paid-in capital | 586,110 | 500,560 | ||||||
Accumulated other comprehensive loss | (28,211 | ) | (8,691 | ) | ||||
Accumulated deficit | (299,068 | ) | (237,150 | ) | ||||
Total shareholders' equity | 258,952 | 254,839 | ||||||
Total liabilities and shareholders' equity | $ | 310,548 | $ | 303,533 | ||||