On November 3, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2022 (Press release, Autolus, NOV 3, 2022, View Source [SID1234623121]).
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"Autolus has continued to deliver further strategic and operational progress during the third quarter of 2022, with our pivotal FELIX trial on track for a Q4 2022 update, the commercial manufacturing facility build on schedule for the handover of the first clean rooms to Autolus, and the announcement post-period end of an agreement for our proprietary technology with Bristol Myers Squibb and an option exercise by Moderna," said Dr. Christian Itin, CEO of Autolus "Alongside this, we have continued progressing our pipeline candidates through Phase 1 clinical trials through our long-standing collaboration with UCL, laying the foundations for our clinical pipeline beyond obe-cel. We are looking forward to updating the market with our progress over the coming months as we remain fully focused on bringing obe-cel to market."
Key Pipeline Programs:
Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL – The FELIX Trial
The pivotal FELIX Phase 2 clinical trial is on track to report initial results in Q4 2022. Autolus plans to present FELIX Phase 2 data at a medical conference in mid-2023. Assuming a positive outcome from the FELIX trial, the Company expects the data to form the basis of a Biologics License Application (BLA) submission for obe-cel to the FDA at the end of 2023.
Obe-cel in r/r adult ALL patients – ALLCAR19 Trial
In collaboration with University College London (UCL), Autolus expects to present long term follow-up data from the Phase 1 ALLCAR19 trial in Q4 2022 at the 2022 ASH (Free ASH Whitepaper) meeting, to be held December 10-13, 2022. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in r/r B-NHL patients – ALLCAR19 Extension Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 ALLCAR19 extension trial. Data were presented at the European Hematology Congress (EHA) (Free EHA Whitepaper) in June 2022, and longer-term follow up will be presented at the 2022 ASH (Free ASH Whitepaper) meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in Primary CNS Lymphoma patients – CAROUSEL Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 CAROUSEL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022 – and longer-term follow up data is planned in 2023.
AUTO1/22 in pediatric ALL patients – CARPALL Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO1/22 Phase 1 CARPALL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO4 in T Cell Lymphoma patients – LibrA T1 Trial
Autolus has optimized the manufacturing process for AUTO4, and is currently enrolling additional patients into the trial to test this manufacturing change. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO8 in Multiple Myeloma – MCARTY Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO8 Phase 1 clinical trial, with first data expected in H2 2023.
AUTO6NG in Neuroblastoma – MCARGD2 Trial
In collaboration with UCL, the first patient is expected to be dosed in the Phase 1 MCARGD2 clinical trial in H1 2023, with initial data expected towards the end of 2023.
Key Operational Updates during Q3 2022
The build phase of the Company’s new 70,000 square foot commercial manufacturing facility in Stevenage, UK has continued to progress on track with the planned schedule during Q3 2022, with Phase 1 of the buildout scheduled to complete in Q4 2022. This first phase includes the first of three cell product commercial manufacturing clean rooms in Stevenage. Final equipment installations and qualification by Autolus are on track for the commencement of Good Manufacturing Practice (GMP) operations in H2 2023. This facility has been designed for a capacity of 2,000 batches per year with the option to expand capacity as needed.
Autolus is on schedule to complete the development work and report generation for the Chemistry Manufacturing and Controls (CMC) package planned to be submitted to the FDA. All work including process qualification activities in the new Stevenage facility are on track for submission of a BLA by the end of 2023.
Post Period End:
In October 2022, Autolus announced a new collaboration with Bristol Myers Squibb, and the exercise of an option by Moderna under an existing license and option agreement announced in August 2021. These two technology deals underscore the scientific capabilities and expertise at Autolus.
Bristol Myers Squibb entered into a licensing agreement with Autolus for access to the Company’s proprietary RQR8 rituximab-induced safety switch for incorporation into a set of selected cell therapy programs, in return for an upfront payment, with potential for near term option exercise fees and development milestone payments plus royalties.
Moderna exercised an option on one of the proprietary binders being developed against an undisclosed immuno-oncology target for the delivery of pioneering messenger RNA (mRNA) therapeutics, in return for an upfront payment, development and commercial milestone payments for each product successfully commercialized, as well as royalties on net sales of all products commercialized under the agreement.
This license option stems from a deal announced on August 2, 2021, granting Moderna an exclusive option to license Autolus’ proprietary binders for incorporation in certain mRNA therapeutics.
Financial Results for the Quarter Ended September 30, 2022
Cash at September 30, 2022, totaled $163.1 million, as compared to cash of $310.3 million at December 31, 2021. Post period end the company received $19.1m in relation to its 2021 U.K research and development tax credit claim.
Net total operating expenses for the three months ended September 30, 2022, were $43.5 million, which included license revenue income of $2.4 million, as compared to net operating expenses of $40.4 million, which included grant income of $0.2 million, for the same period in 2021.
Research and development expenses increased by $5.3 million to $37.6 million for the three months ended September 30, 2022 from $32.3 million for the three months ended September 30, 2021 primarily due to:
an increase of $3.6 million in clinical costs and manufacturing costs primarily relating to the Company’s obe-cel clinical product candidate,
an increase of $2.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
an increase of $0.8 million in legal fees and professional consulting fees in relation to the Company’s research and development activities,
an increase of $0.2 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations.
a decrease of $0.7 million in facilities costs related to the termination and closure of the Company’s US manufacturing facility in 2021 and a shift in the Company’s overall manufacturing strategy, and
a decrease of $0.6 million in depreciation and amortization related to property, plant and equipment and intangible assets.
General and administrative expenses decreased by $0.1 million to $8.2 million for the three months ended September 30, 2022 from $8.3 million for the three months ended September 30, 2021 primarily due to:
an increase of $1.0 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
an increase of $0.1 million in facilities costs due to the increased space utilized for general and administrative activities,
a decrease of $1.1 million primarily related to a reduction in directors’ and officers’ liability insurance premiums, as well as reduced professional fees and information technology costs, and
a decrease of $0.1 million in depreciation and amortization related to property, plant and equipment and intangible assets.
Other (expense) / income net, decreased to an expense of $3.7 million from an income of $1.0 million for the three months ended September 30, 2022 and 2021, respectively. The decrease of $4.7 million is primarily due to the weakening of the pound sterling relative to the U.S. dollar exchange rate during the three month period.
Interest expense increased to $1.9 million for the three months ended September 30, 2022 and relates primarily to the liability related to sale of future royalties and sales milestones which arose upon the Company’s entry into the strategic collaboration and financing agreement with Blackstone, in November 2021. There was no interest expense during the comparable period in 2021.
Income tax benefit increased by $0.8 million to $6.2 million for the three months ended September 30, 2022 from $5.4 million for the three months ended September 30, 2021 due to an increase in qualifying research and development expenditures for the quarter.
Net loss attributable to ordinary shareholders was $42.8 million for the three months ended September 30, 2022, compared to $34.0 million for the same period in 2021. The basic and diluted net loss per ordinary share for the three months ended September 30, 2022, totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.47) for the three months ended September 30, 2021.
Autolus estimates that its current cash on hand and anticipated milestone payments in the relevant period from Blackstone extends the Company’s runway into 2024.
Conference Call
Management will host a conference call and webcast at 8:30 am ET/12:30 pm GMT to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. The webcast can be accessed at this link.
A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.