Autolus Therapeutics Reports Second Quarter 2020 Financial Results and Operational Progress
“We have had a busy second quarter with data updates across our portfolio at key medical and scientific conferences,” said Dr
“At AACR we presented data across a number of next generation programs,” said Dr Martin Pule, chief scientific officer of
AUTO1in acute lymphocytic leukemia (ALL). Positive data were presented at the European Hematology Association (EHA) meeting in June 2020. These data showed an encouraging durability of response without subsequent stem cell transplant and confirmed the safety profile. Autolus has now started enrolment of adult patients with relapsed / refractory ALL in its pivotal Phase 1b/2 AUTO1program and is targeting to have full data by the end of 2021.
- AUTO3 in diffuse large B-cell lymphoma (DLBCL). Positive data were presented at the
American Society of Clinical Oncology(ASCO) meeting in June 2020. These data showed a high level of complete remissions and a safety profile supportive of evaluation of outpatient use. Based on these data, Autolusselected its recommended Phase 2 dose range of 150 - 450 x 106 cells, with a single dose of pembrolizumab during preconditioning. In addition, the company has also commenced an outpatient cohort as an extension to its ongoing Phase 1/2 ALEXANDER study, with results expected in the second half of 2020. The data from this outpatient cohort will provide important insights that will be used to refine the design of the potential pivotal Phase 2 part of the ALEXANDER study. Autolusexpects to present next updated data from the study at ESMO in September 2020.
- AUTO5 in T cell lymphoma. Positive preclinical data were presented at the
American Association for Cancer Research II (AACR) Meetingin June 2020. The data highlight the specificity and selectivity of the company’s T-cell lymphoma product candidate, AUTO5.
- AUTO6NG in small cell lung cancer (SCLC). Positive preclinical data were presented at the AACR Meeting in
June 2020. Autolushas designed enhancing modules to specifically overcome tumor microenvironment (TME) defenses in solid tumor settings. The new data suggest that AUTO6NG can overcome the immune suppressive mechanisms in the TME.
- AUTO7 in prostate cancer. Positive preclinical data were presented at an oral presentation at the AACR Meeting in
June 2020. The program builds on a novel and optimized CAR to PSMA designed to be highly active, even in an acidic environment, and combines modules introduced in AUTO6NG with a novel low level secretion of IL-12 to change the prostate tumor from an immunologically cold to an immunologically supportive environment.
- Appointment of Dr Jay T Backstrom to Autolus’ Board of Directors, effective
August 1, 2020. Dr Backstromcurrently serves as EVP, Head of Research & Development at Acceleron Pharma Inc. and prior to that served as CMO and Head of Regulatory Affairs at Celgene Corporation.
Nushmia Khokharpromoted to Senior Vice President, Clinical Development. Dr Khokharwill take over the clinical leadership role at Autolus. She is a board-certified oncologist with extensive early and late stage clinical development experience, having led several successful registration trials within the industry in both solid tumors and hematologic malignancies, including the global daratumumab program at Janssen Oncology. Dr Vijay Peddareddigari, Senior Vice President, Chief Medical Officer will be leaving the Company to return to the United States.
- Expanded manufacturing capacity at the Cell and Gene Therapy Catapult to secure initial commercial launch capability.
Key Upcoming Clinical Milestones:
- Further update for AUTO3 at ESMO in Q3 2020.
- Further data updates for both
AUTO1and AUTO3 in Q4 2020.
- First data from outpatient cohort in the AUTO3 ALEXANDER study in H2 2020.
- Interim Phase 1 data for AUTO4 in T cell lymphoma in H1 2021.
- Initiation of Phase 1 study for AUTO1NG in pediatric ALL in H2 2020.
- Initiation of Phase 1 study for AUTO8 in multiple myeloma in H2 2020.
- Progression of additional next generation programs from preclinical stages to Phase 1 throughout 2021.
- Expansion of the company’s suite of cell programming technologies to include additional modules designed for allogeneic applications, with the first novel allogeneic program expected to enter the clinic in Q4 2020.
Financial Results for the Quarter Ended
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
Non-cash costs decreased to
General and administrative expenses decreased to
Non-cash costs decreased to
Interest income decreased by
Other income decreased to
Income tax benefit increased to
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
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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
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|Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
|Three Months Ended
||Six Months Ended
|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|
|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||)||$||(1.34||)|
|Weighted-average basic and diluted ordinary shares||52,041,340||43,611,531||50,956,566||41,552,718|
|Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
|Prepaid expenses and other assets, current||35,901||37,826|
|Total current assets||248,731||249,256|
|Property and equipment, net||30,954||28,164|
|Right of use assets, net||25,100||23,409|
|Prepaid expenses and other assets, non-current||2,813||—|
|Deferred tax asset||410||410|
|Intangible assets, net||186||254|
|Liabilities and shareholders' equity|
|Accrued expenses and other liabilities||22,753||21,398|
|Total current liabilities||27,267||24,984|
|Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at
|Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at
|Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at
|Additional paid-in capital||586,110||500,560|
|Accumulated other comprehensive loss||(28,211||)||(8,691||)|
|Total shareholders' equity||258,952||254,839|
|Total liabilities and shareholders' equity||$||310,548||$||303,533|
Source: Autolus Therapeutics plc