On August 5, 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 quarter ended June 30, 2021 (Press release, Autolus, AUG 5, 2021, View Source [SID1234585932]).
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"We are very encouraged by the obe-cel data in adult acute lymphoblastic leukemia (ALL) and in B-cell non-Hodgkins Lymphoma (B-NHL) presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress in June. In adult patients with ALL, event-free survival stabilized at 50% with 12 months follow up and was sustained at 24 months. These data indicate that obe-cel may be the first stand-alone therapy in adult ALL with curative potential in a last line setting. The FELIX trial is progressing well, and we expect pivotal data during 2022," said Dr. Christian Itin, chief executive officer of Autolus. "Additional data were presented at EHA (Free EHA Whitepaper) for obe-cel in indolent B-NHL indicating a high level of clinical activity combined with a well manageable safety profile. Further data in patients with aggressive B-NHL and chronic lymphocytic leukemia (CLL) are expected by the end of the year."
Key Pipeline Updates:
Obe-cel in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
Data presented at EHA (Free EHA Whitepaper) in June 2021 from the ALLCAR19 trial in r/r adult ALL patients demonstrated that obe-cel was generally well tolerated, with no patients experiencing Grade 3 or higher cytokine release syndrome (CRS). Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) that resolved swiftly with steroids. Of the 20 patients treated with obe-cel, 17 (85%) achieved minimum residual disease (MRD)-negative complete remission (CR) at one month. Most notably, as of the data cutoff date of May 17, 2021, the durability of remissions is encouraging. Across all treated patients, event free survival (EFS) at twelve months and twenty-four months was 50.2% with median EFS not being reached.
Obe-cel in other relapsed/refractory B-NHL – ALLCAR19 extension (Cohort D)
Data presented at EHA (Free EHA Whitepaper) in June 2021 in r/r B-NHL (Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)) patients demonstrated that, as of the data cut-off date of May 17, 2021, 9 r/r B-NHL patients (7 FL, 2 MCL) infused with obe-cel achieved a complete metabolic remission and, apart from one, all evaluable patients remained in CR. Obe-cel has a tolerable safety profile in adult patients with r/r FL and MCL, despite high disease burden. Grade 1 CRS was reported in 4 patients and Grade 2 CRS in 1 patient. No ICANS of any grade was observed in the trial.
Obe-cel in high grade B-NHL and CLL – ALLCAR19 extension (Cohorts B & C)
The ALLCAR extension trial also involves two cohorts of patients with high grade B-NHL (DLBCL) and CLL. These cohorts are progressing well and Autolus plans to present updated data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2021.
Autolus received preferred regulatory access for obe-cel from UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA):
Autolus received an innovative licensing and access pathway (ILAP) designation from the MHRA for obe-cel being investigated in the ongoing FELIX trial in ALL.
Autolus received PRIority MEdicines (PRIME) designation from the EMA.
These designations are designed to accelerate the review of a promising therapy targeting an unmet medical need. Data from the FELIX trial is expected in 2022, which, if positive, could enable Autolus to file for accelerated approval.
AUTO4 in Peripheral T Cell Lymphoma (PTCL).
Autolus received ILAP designation from the MHRA for AUTO4 being investigated in PTCL.
AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide a next data update in the first half of 2022.
Operational Highlights:
Post the period end, in July 2021, Autolus announced an agreement with Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, granting Moderna an exclusive license to develop and commercialize mRNA-based therapeutics incorporating Autolus’ proprietary binders to up to four immuno-oncology targets. Under the terms of the agreement, Autolus would be eligible to receive an upfront payment for each target licensed by Moderna and development and commercial milestone payments for each product successfully commercialized. In addition, Autolus will be entitled to receive royalties on net sales of all products commercialized under the agreement. The use of the technology in Moderna’s mRNA platform underscores Autolus’ leadership in the development of innovative differentiated binder and cell programming technologies.
Post the period end, 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. He is part of Autolus’ executive team and is leading the company’s development organization. In addition, Wolfram Brugger M.D., Ph.D. joined Autolus as VP, Head of Clinical Development in June 2021. Wolfram is a highly experienced hematologist, medical oncologist, and internal medicine specialist with 21 years of academia and hospital-based clinical physician experience in hematological malignancies in Germany, including 15 years of leadership as Chief Medical Director at the teaching hospital of Freiburg University. Wolfram joined Autolus from MorphoSys, where he was Head of Global Clinical Programs and oversaw the development of Monjuvi (tafasitamab).
Key Upcoming Clinical Milestones:
Obe-cel updates from the ALLCAR19 extension trial in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort in H2 2021
Obe-cel currently enrolling the FELIX trial in r/r adult ALL patients with pivotal data expected in 2022
Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022
Updates on the AUTO1/22 CARPALL extension trial in pediatric ALL in Q4 2021
Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL in H1 2022
Phase 1 trials are expected to be initiated in H2 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
First exploratory allogeneic development candidate expected to enter the clinic in 2021
Financial Results for the Quarter Ended June 30, 2021
Cash at June 30, 2021, totaled $216.4 million, as compared to $239.0 million at March 31, 2020. During the three months ended June 30, 2021, the company issued an aggregate of 2,069,466 ADSs under its Sales Agreement with Jefferies for net proceeds, after underwriting discounts and offering expenses, of $14.3 million.
Net total operating expenses for the three months ended June 30, 2021 were $37.7 million, net of grant income and license revenue of $1.6 million, as compared to net operating expenses of $39.5 million, net of grant income of $0.3 million, for the same period in 2020.
Research and development expenses increased to $32.1 million for the three months ended June 30, 2021, from $31.3 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $29.2 million from $26.5 million. The increase in research and development cash costs of $2.7 million consisted primarily of (i) an increase in compensation and employment related costs of $0.7 million due to severance payments related to the reduction in workforce that started in the first quarter, and offset by a reduction in employment costs due to a decrease in headcount, (ii) an increase of $1.0 million in facilities costs related to the continued scaling of manufacturing operations, (iii) an increase of $0.9 million related to purchased materials, (iv) an increase of $0.3 million related to cell logistics, and (v) an increase of $0.3 million related to IT infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. This was offset by a decrease of $0.4 million in clinical costs and $0.1 million of legal expenses.
Non-cash costs decreased to $2.9 million for the three months ended June 30, 2021, from $4.8 million for the three months ended June 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $2.8 million as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSUs related to employees affected by the reduction in workforce. This was offset by an increase in depreciation of $0.9 million.
General and administrative expenses decreased to $7.2 million for the three months ended June 30, 2021, from $8.5 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $6.6 million from $6.7 million. The decrease in general and administrative cash costs of $0.1 million related to decreases of (i) $0.3 million related to the reduction in workforce that began to take place in the first quarter, which reduced the headcount, and (ii) $0.3 million of expenses related to preparations for becoming a commercial stage company. These decreases were offset by an increase of $0.5 million in legal fees and directors & officers liability insurance premiums.
Non-cash costs decreased to $0.6 million for the three months ended June 30, 2021, from $1.8 million for the three months ended June 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 RSUs related to employees affected by the reduction in workforce.
Other income/(expense) decreased by $2.3 million for the three months ended June 30, 2021, from other income of $0.5 million for the three months ended June 30, 2020, to an other expense of $1.8 million. The decrease was primarily due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended June 30, 2021 as compared to the three months ended June 30, 2020.
Income tax benefit decreased to $6.4 million for the three months ended June 30, 2021 from $7.0 million for the three months ended June 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 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 $33.2 million for the three months ended June 30, 2021, compared to $32.1 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended June 30, 2021 totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.62) for the three months ended June 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/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 9757293. 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 9757293.