On November 3, 2021 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, 2021 (Press release, Autolus, NOV 3, 2021, View Source [SID1234594461]).
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"We continue to make good progress on the clinical evaluation of obe-cel in the Phase 2 portion of the FELIX study and remain on track to deliver primary endpoint data in the middle of 2022. We are also pleased to update that the response rate and safety data from patients in the multi-center Phase 1b cohort are consistent with the data reported from the academic ALLCAR19 study of obe-cel in relapsed/refractory adult B-acute lymphoblastic leukemia (ALL)," said Dr. Christian Itin, chief executive officer of Autolus. "In addition, we expect a busy end of the year with clinical data at the upcoming 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), including an oral presentation, where we will provide early clinical data from the Phase 1b trial, as well as a poster presentation covering clinical data from the ALLCAR19 extension trial and a poster with initial clinical data for AUTO1/22."
Key Pipeline Updates:
Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL.
FELIX Study – Autolus continues to enroll patients in the Phase 2 portion of the FELIX study. The multi-center study is progressing well, with consistent one-month complete response rate and safety data observed from the initial 16 patients in the Phase 1b cohort as compared to data reported from the academic ALLCAR19 study of obe-cel in r/r adult ALL. Autolus expects to present early clinical data from the Phase 1b portion of the FELIX trial at the 63rd ASH (Free ASH Whitepaper) Meeting in December 2021. The Company reiterates its expectation of pivotal data in 2022.
ALLCAR19 Study – Data were published in the Journal of Clinical Oncology (JCO) in September 2021 from the ALLCAR19 trial in r/r adult ALL patients. Obe-cel demonstrated a manageable adverse events profile, with no patients experiencing high grade (≥ grade 3) cytokine release syndrome (CRS), despite the majority having a high disease burden prior to lymphodepletion1. CAR T cell concentration reached very high levels at peak (mean peak CAR T concentration (Cmax) by quantitative polymerase chain reaction (qPCR) was 127,152 copies/µg genomic DNA1) and persistence in peripheral blood was evident in 15/20 (75%) patients at a median of 166.5 days, with 4/20 (20%) patients having follow-up duration over 2 years, and 3/4 of these patients with ongoing CAR persistence at the data cut-off date of February 26, 20211. B-cell aplasia was ongoing in 15/20 patients at the last observation date of February 26, 20211. Of the 20 patients, 85% patients achieved minimal residual disease (MRD) negative complete response (CR) at month 11. Duration of response remains highly encouraging. With a data cut-off date of May 17, 2021, and as presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress in June 2021, event free survival (EFS) at 12 months and 24 months was 50.2%, with median EFS not reached across all patients treated2.
1Roddie et al. "Durable responses and low toxicity after fast off-rate CD19 CAR-T therapy in adults with relapsed/ refractory B-ALL." DOI: 10.1200/JCO.21.00917 Journal of Clinical Oncology – published online before print August 31, 2021
2Roddie et al. "Early Safety and Efficacy Findings of AUTO1 (CAT19), a Fast-Off Rate CD19 CAR, in Relapsed/Refractory Indolent B Cell Lymphomas." EHA (Free EHA Whitepaper) annual meeting, June 11 2021, abstract EP788. EHA (Free EHA Whitepaper) Investor slide presentation
Obe-cel in r/r B-NHL – ALLCAR19 extension
The latest data of obe-cel were presented by Autolus at EHA (Free EHA Whitepaper) in June 2021 in r/r B-NHL (Follicular Lymphoma and Mantle Cell Lymphoma) patients. The trial is progressing well and Autolus plans to present updated data from the ALLCAR extension trial at the ASH (Free ASH Whitepaper) Meeting in December 2021.
AUTO4 in Peripheral T Cell Lymphoma
The AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide its next data update from the trial in the first half of 2022.
AUTO8 in Multiple Myeloma
The Company is on track to start a Phase 1 trial in the fourth quarter of 2021.
Operational Highlights:
Updates to Autolus’ Executive team
In July 2021, Autolus announced the appointment of Edgar Braendle M.D., Ph.D., as Chief Development Officer. Dr Braendle is an experienced oncologist who joined Autolus from Sumitomo Dainippon Pharma Oncology, where he held the position of Chief Medical Officer and Global Head of Development and was responsible for leading the global oncology development programs of Sumitomo Dainippon. In addition, in June 2021, Wolfram Brugger M.D., Ph.D. joined Autolus as its Vice President, Head of Clinical Development. Dr. Brugger joined Autolus from MorphoSys, where he was Head of Global Clinical Programs and oversaw the development of Monjuvi (tafasitamab).
In October 2021, Alexander Swan was promoted to Senior Vice President, Human Resources. Mr. Swan joined Autolus prior to its Nasdaq listing in 2018 as Vice President, Human Resources. Prior to that, he was EMEA Head of Human Resources for Kite where he was responsible for all aspects of human resources.
Also in October 2021, Dr. Chris Williams was promoted to Senior Vice President, Corporate Development. Dr. Williams was part of the team that founded Autolus in 2014, and he initially served on the Company’s board of directors as a Non-Executive Director from September 2014 to July 2016. In 2016, Dr. Williams transitioned into the Company to establish Autolus’ business development function. Previously he worked at UCL Business, Orchard Therapeutics, Eli Lilly, and GSK.
Matthias Alder, Senior Vice President, Chief Business Officer and Company Secretary, left Autolus at the end of September 2021. The Company would like to thank Mr. Alder for his contributions and wishes him well in the future.
In September 2021, Autolus announced the appointment of John H. Johnson as non-executive chairman of its Board of Directors. Mr. Johnson brings to Autolus more than 30 years of experience in the life science industry. He most recently was chief executive officer and a director of Strongbridge Biopharma plc, a Nasdaq-listed commercial stage biopharmaceutical company. He previously served as the executive chairman of Strongbridge Biopharma from November 2019 to July 2020, and as chairman from March 2015 to November 2019. He is a recognized leader in the biopharmaceutical industry and has held executive, operations and commercial leadership roles at Eli Lilly & Company, ImClone, Johnson & Johnson, and Pfizer. He also currently serves as a member of the Board of Directors of Xeris Biopharma Holdings, Inc., Verastem, Inc. and Axogen, Inc. Mr. Johnson previously served on the Board of Directors of the Pharmaceutical Research and Manufacturers of America and the Health Section Governing Board of the Biotechnology Industry Organization (now known as the Biotechnology Innovation Organization).
In September 2021, Autolus gave an update on its manufacturing strategy, announcing that planning approval had been granted to build the Company’s new manufacturing facility in Stevenage, UK. The 70,000 square foot facility is being built by Merit Holdings Limited as general contractor for the Reef Group, who will lease the facility to Autolus. Global commercial launch capacity for obe-cel will initially be provided by the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult facility, and will then move to the new Autolus facility, which will allow for good manufacturing practice capacity for approximately 2,000 batches a year initially, with scope to expand.
As previously announced, in July 2021, Autolus announced its entry into an agreement with Moderna, Inc., granting Moderna an exclusive license to develop and commercialize mRNA-based therapeutics incorporating Autolus’ proprietary binders for up to four immuno-oncology targets.
Key Anticipated Clinical Milestones:
Updates on the FELIX trial, where Autolus is evaluating obe-cel in r/r adult ALL patients. The trial is currently enrolling patients into the Phase 2 portion. Initial data on the Phase 1b portion of the trial planned to be presented at the ASH (Free ASH Whitepaper) Meeting in December 2021. Autolus expects data from the Phase 2 trial to be available in 2022
Updates from the ALLCAR19 extension trial in patients with r/r B-NHL and longer-term follow-up of the fully enrolled r/r adult ALL cohort expected at ASH (Free ASH Whitepaper) Annual Meeting in December 2021
Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022
Non-clinical data and initial data from the AUTO1/22 CARPALL extension trial in pediatric ALL expected at ASH (Free ASH Whitepaper) in December 2021
Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL expected in H1 2022
Phase 1 trials are expected to be initiated in Q4 2021 with AUTO8 in Multiple Myeloma
Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL
Financial Results for the Quarter Ended September 30, 2021
Cash at September 30, 2021, totaled $173.1 million, as compared to $216.4 million at June 30, 2021.
Net total operating expenses for the three months ended September 30, 2021, were $40.4 million, net of grant income of $0.2 million, as compared to net operating expenses of $42.7 million, net of grant income of $0.4 million and license revenue of $0.2 million, for the same period in 2020.
Research and development expenses decreased to $32.3 million for the three months ended September 30, 2021 from $33.5 million for the three months ended September 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, decreased to $29.4 million from $30.0 million. The decrease in research and development cash costs of $0.6 million consisted primarily of (i) $1.4 million decrease in clinical costs and manufacturing costs (ii) $0.2 million decrease of consultancy fees related to our clinical pipeline, (iii) $0.3 million decrease in facilities costs related to the termination of our US manufacturing facility and shift in manufacturing strategy, (iv) $0.4 million in research and development costs related to cell logistics and (v) $0.1 million decrease related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations . This was offset by (i) an increase of $1.0 million related to purchased consumables for the manufacture of obe-cel in our Phase 2 FELIX clinical trial and (ii) an increase in compensation and employment related costs of $0.8 million net, due to a combination of severance payments which are offset by a reduction in employment costs for a decrease in headcount.
Non-cash costs decreased to $2.9 million for the three months ended September 30, 2021 from $3.5 million for the three months ended September 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $1.6 million as a result of the lower fair value of stock options granted during the period, combined with forfeitures of incentive share options and unvested RSU awards. This was offset by an increase in depreciation expense of $1.0 million.
General and administrative expenses decreased to $8.3 million for the three months ended September 30, 2021 from $9.8 million for the three months ended September 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $7.2 million from $7.7 million. The decrease in general and administrative cash costs of $0.5 million related to decreases of (i) $0.2 million associated with compensation expense due to a reduction in headcount, (ii) $0.8 million of expenses related to preparations for becoming a commercial stage company, and (iii) $0.4 million in facilities costs related to the termination lease and exit of our lease agreements. These decreases were offset by an increase of $0.8 million which was primarily related to professional services fees and directors and officers liability insurance premiums and $0.1 million in costs related to IT infrastructure and support for information systems.
Non-cash costs decreased to $1.1 million for the three months ended September 30, 2021 from $2.1 million for the three months ended September 30, 2020. The decrease is mainly attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSU awards related to employees affected by our reduction in workforce.
Other income / (expense) increased by $3.5 million for the three months ended September 30, 2021, from other expense of $2.5 million for the three months ended September 30, 2020 to other income of $1.0 million. The increase was primarily due to the strengthening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended September 30, 2021 as compared to the three months ended September 30, 2020.
Income tax benefit decreased to $5.4 million for the three months ended September 30, 2021 from $7.9 million for the three months ended September 30, 2020 due to a decrease in the research and development expenditures which were qualifying for the quarter. As research and development credits fell at a faster rate than our net loss before income tax, this led to a lower 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 decrease in the net credit was primarily attributable to a decrease in our eligible research and development expenses.
Net loss attributable to ordinary shareholders was $34.0 million for the three months ended September 30, 2021, compared to $37.3 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended September 30, 2021, totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.72) for the three months ended September 30, 2020.
Autolus estimates that its current cash on hand will provide the Company with a cash runway into H1 2023.
Conference Call
Management will host a conference call and webcast today at 8:30 am ET/12:30 pm GMT to discuss the Company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.
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 6984737. 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 6984737.