On May 5, 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 quarter ended March 31, 2022 (Press release, Autolus, MAY 5, 2022, View Source [SID1234613693]).
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"The momentum at Autolus has continued during the first quarter. We are delighted to note that the FELIX clinical trial of obe-cel in patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) passed its futility analysis during the period and we continue to enroll patients as planned, with initial data expected in the second half of 2022, with the full data in the first half of 2023," said Dr. Christian Itin, Chief Executive Officer of Autolus. "obe-cel recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), supporting our drive to bring this innovative therapy to patients as quickly as possible."
"We also have updates at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in early June from four Phase 1 clinical trials. Two trials are evaluating obe-cel in B-Cell Non-Hodgkin’s Lymphoma (B-NHL) and primary CNS lymphoma (PCNSL). In addition, two oral presentations will cover the first clinical data for AUTO4 in TRBC1+ Peripheral T cell lymphoma (PTCL) and data for the dual targeting AUTO1/22 in pediatric ALL patients."
Key Pipeline Updates:
Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL
During the quarter, the FELIX study passed its pre-specified futility analysis based on the results assessed by an independent response review committee. As previously guided, the morphological cohort is expected to complete enrollment in 2022 with initial data from the FELIX study expected to be reported in H2 2022 and full data in H1 2023. Assuming a positive outcome from the FELIX study, this data is expected to form the basis of a planned Biologics License Application (BLA) submission by the Company.
Autolus plans to evaluate a separate cohort of up to 50 additional patients with Minimal Residual Disease (MRD). The additional data aims to establish the profile of obe-cel in patients across all levels of disease burden in adult ALL.
In March 2022 obe-cel was granted Orphan Medical Product Designation by the European Medicines Agency (EMA) for the treatment of ALL, having previously received Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for B-ALL.
Obe-cel in r/r B-NHL – ALLCAR19 Extension Trial
Subjects continue to be enrolled into the Phase 1 ALLCAR19 extension trial. The latest data readout from this extension study of obe-cel in patients with r/r B-Cell Non-Hodgkin’s Lymphoma (B-NHL) and Chronic Lymphocytic Leukemia (CLL) were presented at ASH (Free ASH Whitepaper) in December 2021. Updated data from the trial will be presented as a poster at the EHA (Free EHA Whitepaper) Congress in June.
Obe-cel in PCNSL – CAROUSEL Trial
Subjects continue to be enrolled into the Phase 1 CAROUSEL trial. Data from the trial will be presented as a poster at the EHA (Free EHA Whitepaper) Congress in June.
AUTO1/22 in pediatric ALL – CARPALL Trial
Autolus continues to enroll patients into the AUTO1/22 Phase 1 CARPALL trial. Initial clinical data from the trial will be presented as an oral presentation at the EHA (Free EHA Whitepaper) Congress in June.
AUTO4 in Peripheral T Cell Lymphoma – LibrA T1 Trial
Autolus continues to enroll patients into the AUTO4 Phase 1 clinical trial, which is progressing through its dose escalation phase. Interim Phase 1 data will be presented as an oral presentation at the EHA (Free EHA Whitepaper) Congress in June.
AUTO6NG in Neuroblastoma
Autolus plans to initiate a Phase 1 clinical trial of AUTO6NG in patients with neuroblastoma in H2 2022.
AUTO8 in Multiple Myeloma – MCARTY Trial
During the period, Autolus initiated a Phase 1 clinical trial of AUTO8, the Company’s next-generation product candidate for multiple myeloma. AUTO8 comprises two independent CARs targeting BCMA and CD19 designed to induce deep and durable responses and extend the durability of effect.
Key Operational Updates during Q1 2022
Effective March 31, 2022, Dr. Lucinda Crabtree was appointed as Chief Financial Officer succeeding Andrew J. Oakley upon his retirement. Dr. Crabtree served as SVP Finance prior to her promotion.
Good progress is being made in the build phase of the Company’s new 70,000 square foot commercial manufacturing facility in Stevenage, UK. This facility is expected to be ready for GMP operations by H2 2023 and is designed for a capacity of 2,000 batches a year with the option to expand.
Post Period Updates:
On 25 April, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel, in recognition of the therapy’s potential to address significant unmet medical needs in patients with serious or life-threatening conditions. RMAT designation provides important benefits in the drug development process, designed to facilitate and expedite development and regulatory review. Obe-cel also received PRIME designation from EMA and ILAP from MHRA.
On 2 May, Autolus announced the online publication of three abstracts submitted to the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) to be held May 16-19, 2022. The three abstracts focus on Autolus’ modular approach to CAR T product development, using innovative technology to improve our pipeline of precise, controlled and highly active products. The three abstracts cover: 1) enhancing CAR T therapy using constitutively active cytokine receptors, 2) engineering CAR T cells to express a Fas-CD40 to increase its persistence and tumor cytotoxicity and 3) developing a minocycline mediated protein-protein displacement platform to make cell therapies tunable, dose dependent and reversible.
Key Anticipated Clinical Milestones:
Initial clinical data from the FELIX Phase 2 trial in H2 2022 and full data in H1 2023.
Updated Phase 1 data from the ALLCAR19 extension trial in patients with r/r B-NHL and CLL presented as a poster at the EHA (Free EHA Whitepaper) Congress in June 2022.
Updates on the obe-cel Phase 1 CAROUSEL trial in Primary CNS Lymphoma presented as a poster at the EHA (Free EHA Whitepaper) Congress in June 2022.
Initial clinical data from the AUTO1/22 CARPALL extension trial in pediatric ALL presented as an oral presentation at the EHA (Free EHA Whitepaper) Congress in June 2022, with longer follow up in H2 2022.
Initial clinical data from AUTO4 LibraT1 Phase 1 trial in TRBC1+ Peripheral TCL presented as an oral presentation at the EHA (Free EHA Whitepaper) Congress in June 2022.
AUTO6NG Phase 1 clinical trial in neuroblastoma expected to start in H2 2022. Expect first data in H2 2023.
AUTO8 Phase 1 clinical trial in patients with multiple myeloma has started, expect first data in H2 2023.
Financial Results for the Quarter Ended March 31, 2022
Cash at March 31, 2022, totaled $268.6 million, as compared to $310.3 million at December 31, 2021.
Total operating expenses, net of grant income of $0.2 million, for the three months ended March 31, 2022, were $41.8 million, as compared to total operating expenses, net of grant income of $0.3 million, of $39.9 million for the same period in 2021.
Grant income decreased by $0.1 million to $0.2 million for the three months ended March 31, 2022, as compared to $0.3 million for the same period in the prior year. The decrease is due to a corresponding decrease in reimbursable expenditures.
Research and development expenses increased to $34.0 million for the three months ended March 31, 2022, as compared to $30.7 million for the three months ended March 31, 2021. Cash costs decreased to $30.6 million from $30.7 million. The decrease in research and development cash costs of $0.1 million consisted primarily of (i) $2.8 million decrease in compensation and employment related costs which was due to a combination of lower retention, severance payments and timing and salary mix of new employee hires, (ii) $0.9 million decrease in facilities costs related to the termination and exit of the Company’s US manufacturing facility in 2021 and shift in its manufacturing strategy, and (iii) $0.2 million in research and development costs related to cell logistics.
This was offset by an increase of (i) $2.9 million in clinical costs and manufacturing costs primarily relating to the Company’s obe-cel clinical product candidate, (ii) $0.8 million increase in legal fees and professional consulting fees in relation to our research and development activities, and (iii) $0.1 million increase related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations.
Non-cash costs increased to $3.4 million for the three months ended March 31, 2022 from $36,000 for the three months ended March 31, 2021. The increase is primarily attributable to an increase of $3.1 million in share-based compensation expense included in research and development expenses as a result of retention of employees post the reduction of workforce that was implemented during the three months ended March 31, 2021. In addition, depreciation and amortization expense increased by $0.3 million.
General and administrative expenses decreased by $0.7 million to $8.0 million for the three months ended March 31, 2022, from $8.7 million for the three months ended March 31, 2021. Cash costs, which exclude depreciation and amortization as wells as share-based compensation decreased to $7.0 million from $7.6 million. The decrease in general and administrative cash costs of $0.6 million related to decreases of (i) $0.5 million in facilities costs related to the termination and exit of the Company’s lease agreements in the prior year, (ii) $0.4 million of commercial preparation costs due to the timing of related activities and (iii) $0.3 million associated with compensation expense due to fewer contracted staff. These decreases were offset by increases of $0.5 million primarily related to higher directors’ and officers’ liability insurance premiums and professional fees in relation to business development opportunities and $0.1 million in costs related to information technology infrastructure and support for information systems.
Non-cash costs decreased by $0.1 million to $1.0 million for the three months ended March 31, 2022 from $1.1 million for the three months ended March 31, 2021. The decrease of $0.1 million primarily related to a decrease in depreciation and amortization expense.
There were no disposals of leasehold improvements for the three month period ended March 31, 2022. For the three months ended March 31, 2021, the Company incurred a loss on disposal of leasehold improvements of $0.7 million related to the leasehold improvements no longer being utilized in its facility in White City, London.
Other income, net for the three months ended March 31, 2022, was consistent with the three months ended March 31, 2021. During the three months ended March 31, 2022 there was a strengthening of the U.S. dollar exchange rate relative to the pound sterling resulting in a foreign exchange gain of $0.8 million. This compares to the three months ended March 31, 2021 where there was a gain on lease terminations of $2.0 million offset by other expenses of $1.2 million related to a foreign exchange loss.
Interest expense increased to $1.8 million for the three months ended March 31, 2022 and relates to the liability related to sales of future royalties and sales milestones which arose upon entering into the Blackstone Strategic Collaboration and Financing Agreement with BXLS V – Autobahn L.P., in November 2021. There was no interest expense during the comparable period in 2021.
Income tax benefit decreased by $0.1 million to $5.6 million for the three months ended March 31, 2022 from $5.7 million for the three months ended March 31, 2021 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 the Company’s net loss before income tax, this led to a lower effective tax rate.
Net loss attributable to ordinary shareholders was $37.1 million for the three months ended March 31, 2022, compared to $33.3 million for the same period in 2021. The basic and diluted net loss per ordinary share for the three months ended March 31, 2022, totaled $(0.41) compared to a basic and diluted net loss per ordinary share of $(0.53) for the three months ended March 31, 2021.
Autolus estimates that its current cash on hand and anticipated milestone payments from Blackstone extends the Company’s runway into 2024.
Conference Call
Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST 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: 3245616. 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: 3245616.