On May 6, 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 March 31, 2021 (Press release, Autolus, MAY 6, 2021, View Source [SID1234579395]).
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"We have had a productive first quarter and are on track for multiple clinical read outs during the remainder of this year and into 2022," said Dr. Christian Itin, chief executive officer of Autolus. "We are excited by the unique characteristics of AUTO1 and encouraged by what we believe is the significant clinical benefit AUTO1 can offer for patients with relapsed/refractory (r/r) Acute Lymphoblastic Leukemia (ALL). AUTO1 is being evaluated in the P1b/2 FELIX study in adult ALL patients with data expected in 2022. In addition, AUTO1 is being explored in patients with B-NHL and in primary CNS lymphoma, and we are also evaluating AUTO1/22 in pediatric ALL patients. Finally, several programs are expected to enter the clinic in 2021, including our next generation program AUTO6NG in Neuroblastoma, setting up clinical news flow for 2022 and beyond."
Key Pipeline Updates:
AUTO1 in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
The International Nonproprietary Name (INN) name (obecabtagene autoleucel, or obe-cel) was published.
Autolus received PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for AUTO1 being investigated in the ongoing FELIX Phase 1b/2 clinical trial in ALL. This designation is designed to accelerate the review of a promising therapy targeting unmet medical need. Data from this potentially pivotal program is expected in 2022, which, if positive, could enable us to file for accelerated approval.
AUTO1 in indolent B cell Non-Hodgkin Lymphoma (NHL) (cohort 1), high grade B-NHL (cohort 2) and chronic lymphocytic leukemia (CLL) (cohort 3).
The trial is progressing well and Autolus will present updated data at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2021.
AUTO4 in Peripheral T Cell Lymphoma (PTCL).
Autolus received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO4, which is currently being studied in a Phase 1 clinical trial in PTCL. As with the AUTO1 PRIME designation, this is intended to accelerate the review of a promising therapy targeting unmet medical need. Autolus expects to provide a next data update in the second half of 2021.
Partnerable Coronavirus Disease (COVID-19) Project. Autolus’ research team has developed a potentially universal SARS-CoV2 decoy receptor with virus neutralizing activity against SARS-CoV2 and its variants and also active against SARS-CoV1.
Operational Highlights:
In the first quarter of 2021, Autolus sold an aggregate of 1,718,506 ADSs in offerings under its Open Market Sales AgreementSM with Jefferies LLC, for net proceeds of approximately $15.3 million.
Successful closing of a follow-on public offering raising net proceeds to Autolus, after underwriting discounts and offering expenses, of $106.9 million in February 2021, taking total net cash raised in Q1 2021 to approximately $122.2 million.
As announced in Autolus’ business update in January 2021, Autolus has realigned its research and development resources to prioritize the AUTO1 program and plans to partner the AUTO3 program before progressing it into the next phase of development.
Also announced in Autolus’ business update in January 2021, the company adjusted its workforce and infrastructure footprint, including an overall reduction in headcount of approximately 20%. Autolus expects to realize cash savings, on an annualized basis, of approximately $15 million with the operational changes fully implemented.
In March 2021, Autolus announced it was establishing global commercial launch manufacturing capacity in the UK, enabling the company to leverage the expertise and skill base of its U.K. employees. As a result, future commercial supply will be provided by a combination of the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult (CGTC) facility and a new Autolus facility. This revised strategy aims to deliver a less capital-intensive commercial manufacturing infrastructure at a lower cost base. In conjunction, Autolus announced the termination of its lease for the manufacturing and office facility in, Rockville, MD, resulting in a cash payment to Autolus of $2.0 million.
Dr Muhammad Al-Hajj, Senior Vice President, Translational Sciences, left the Company in April 2021. The company would like to thank Dr. Al-Hajj for his contributions and wishes him well in the future.
Post the period end, Dr Martin Murphy was appointed non-executive chairman of Autolus.
Key Upcoming Clinical Milestones:
AUTO1 updates in 2021 on ALLCAR19 in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort.
AUTO1 – Currently enrolling a potentially pivotal Phase 1b/2 clinical trial (FELIX) in r/r adult ALL patients with data expected in 2022.
Updates on Phase 1 programs AUTO1/22 in pediatric ALL, as well as AUTO4 in TRBC1+ Peripheral TCL, in 2021.
Phase 1 trials are expected to be initiated in 2021 with AUTO1 in Primary CNS Lymphoma, AUTO5 in TRBC2+ Peripheral TCL, AUTO6NG in Neuroblastoma, and AUTO8 in Multiple Myeloma.
First exploratory allogeneic program expected to enter the clinic in 2021.
Financial Results for the Quarter Ended March 31, 2021
Cash at March 31, 2021 totaled $239.0 million, as compared to $153.3 million at December 31, 2020. In January 2021, the company sold 1.7 million ADSs under its Open Market Sales AgreementSM with Jefferies LLC as sales agent, resulting in net proceeds of $15.3 million and in February 2021, the company sold 16.4 million ADSs representing 16.4 million ordinary shares in a follow-on, public offering, including the exercise in full by the underwriters of their option to purchase an additional 2.1 million ADSs, at a public offering price of $7.00 per ADS, yielding net proceeds of $106.9 million.
Net total operating expenses for the three months ended March 31, 2021 were $39.9 million, net of grant income of $0.3 million, as compared to net operating expenses of $38.6 million, net of grant income of $0.3 million, for the same period in 2020.
Research and development expenses decreased to $30.7 million for the three months ended March 31, 2021 from $31.3 million for the three months ended March 31, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $30.7 million from $25.6 million. The increase in research and development cash costs of $5.1 million consisted primarily of (i) an increase in compensation and employment related costs, net of lower travel costs (as a result of restricted travel due to the ongoing COVID-19 pandemic), of $3.5 million due to a combination of an increase in employee headcount to support the advancement of our product candidates in clinical development and severance payments related to the reduction in workforce that began to take place during the quarter, (ii) an increase of $2.2 million in facilities costs related to the continued scaling of manufacturing operations, and (iii) an increase of $0.4 million related to cell logistics, which is offset by decreases in purchased materials in the amount of $0.6 million and project expenses of $0.4 million.
Non-cash R&D costs decreased to $36,000 for the three months ended March 31, 2021 from $5.7 million for the three months ended March 31, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $6.2 million as a result of forfeitures of incentive share options related to employees affected by the reduction in workforce. This was offset by an increase in depreciation of $0.5 million.
General and administrative expenses increased to $8.7 million for the three months ended March 31, 2021 from $7.6 million for the three months ended March 31, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation increased to $7.6 million from $5.9 million. The increase in general and administrative cash costs of $1.7 million related to an increase of (i) $0.4 million in facilities cost, (ii) an increase of $0.6 million in legal fees and audit fees, (iii) an increase of $0.3 million of expenses related to preparations for becoming a commercial stage company, and (iv) an increase of $0.4 million in compensation and employment related costs due to an increase in headcount, and severance payments related to the reduction in workforce that began to take place during the quarter.
Non-cash general and administrative costs decreased to $1.1 million for the three months ended March 31, 2021 from $1.7 million for the three months ended March 31, 2020. The decrease is attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period. Loss on disposal of leasehold improvements of $0.7 million related to the leasehold improvements no longer being utilized in the facility in White City, London.
Interest income decreased by $0.5 million for three months ended March 31, 2021 due to lower interest rates for cash held on deposit. Other income decreased by $3.7 million for the three months ended March 31, 2021 from other income of $4.5 million for the three months ended March 31, 2020 to $0.8 million. There was a decrease of $5.6 million primarily due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended March 31, 2021 as compared to the three months ended March 31, 2020, offset by gains on lease terminations of $2.0 million, net of the related expenses.
Income tax benefit increased to $5.7 million for the three months ended March 31, 2021 from $3.7 million for the three months ended March 31, 2020 due to increased research and development credits. As research and development credits grew at a faster rate than our net loss before income tax, this led to a higher 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 $33.3 million for the three months ended March 31, 2021, compared to $29.9 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended March 31, 2021 totaled $(0.53) compared to a basic and diluted net loss per ordinary share of $(0.60) for the three months ended March 31, 2020.
Autolus estimates that its current cash on hand will provide the Company with a cash runway into the first half of 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 7756178. 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 7756178.