Earnings Call Transcript - AUTL Q1 2023

Operator, Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics First Quarter 2023 Financial Results Conference Call and Operational Progress. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. As a reminder, today's conference is being recorded. I would now like to turn the conference over to your host, Alexandra Deschner, Investor Relations Consultant. Alexandra, please go ahead.

Alexandra Deschner, Investor Relations Consultant

Thank you so much, Eric. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus' first quarter 2023 financial results and operational highlights. I'm Alexandra Deschner, Investor Relations Consultant for Autolus. With me today are Dr. Christian Itin, our Chief Executive Officer; and Dr. Lucinda Crabtree, our Chief Financial Officer. Before we begin, I would like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the status of clinical trials and development and/or regulatory timeliness for our product candidates and our expectations regarding our cash runway. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and our SEC filings, both available on the Investors section of our website. On Slide 3, you will see the agenda for today's call, which is as follows: Christian will provide an overview of our operational highlights for the first quarter of 2023. Lucy will then discuss the company's first quarter 2023 financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions. Over to you, Christian.

Christian Itin, CEO

Thank you, Alexandra, and good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the first quarter in 2023. Moving to Slide number 4. We're really pleased with our program and operational progress during the first quarter of 2023, which is highlighted over the next four slides. We're making good progress with our pipeline of CAR-T programs, particularly with our elite product, Obe-cel, in relapsed/refractory adult ALL patients. You will recall that we announced in December that the Phase II pivotal clinical trial of Obe-cel in this patient population has met its primary endpoint based on a pre-planned interim analysis of 50 patients with morphological disease and as verified by an independent data monitoring committee. This positive data triggered a $35 million milestone for our partner Blackstone Life Sciences earlier than anticipated. We're looking forward to presenting the top-line data of the FELIX study in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 2 in Chicago and a second oral presentation at the European Hematology Association Congress being held from the 8th to the 11th of June in Frankfurt. Updates on longer follow-up and additional sub-analysis of the data are planned for the American Society of Hematology meeting at the end of 2023 as well as at medical conferences in the first half of 2024. Operationally, the key goal for Obe-cel is the filing for a biologics license application to the U.S. Food and Drug Administration by the end of this year. In February, Dr. Claire Rode from UCL presented long-term follow-up data from our adult ALL patients in the ALLCAR19 Phase I study of Obe-cel at the Tandem Meetings of ASTCT and CIBMTR. The data demonstrated that 35% of adult patients remain in complete remission without additional anti-leukemia therapy, an immediate follow-up of 36 months with ranges from 24 months to 48 months. We're now looking at the broader range of development options for Obe-cel and AUTO122 beyond adult patients with acute lymphoblastic leukemia. In the ALLCAR extension study, we have reported Obe-cel's high level of clinical activity and well-manageable safety profile across non-Hodgkin's lymphoma indications and chronic lymphocytic leukemia. We're completing enrollment in this study and expect to report final data in a peer-reviewed publication. In the CAROUSEL study, we evaluate Obe-cel in peripheral CNS lymphoma, and we have completed enrollment and continue to see consistent and encouraging safety and efficacy, with adequate follow-up; we are planning to publish the full data in a peer-reviewed journal as well. We're following with interest the early and very encouraging results from the team at the University of Erlangen, Germany, and Andreas Mackensen in patients with refractory systemic lupus and related B cell-mediated autoimmune diseases treated with an academic CD19 CAR-T product. Considering Obe-cel's excellent activity and safety profile and combined with our commercial manufacturing base, this set of indications may become an attractive additional opportunity for the program. In an oral presentation at the 49th European Bone Marrow and Transplant Meeting in April, our key investigator Dr. Sara Ghorashian and Perseomrolia from Great Ormond Street Hospital in London, presented updated data from AUTO1/22, our CD19 and CD22 dual targeting CAR-T product candidate. Kymriah ineligible pediatric ALL patients showed a high level of clinical activity and good tolerability with over 80% of patients achieving a molecular complete remission with no antigen negative relapses seen with a median follow-up of 8.7 months. Included also were patients who had relapsed after Kymriah therapy with CD19 negative disease. Additionally, data on the molecular design of AUTO1/22 and preclinical characterizations were published in Molecular Therapy in March and highlighted the state-of-the-art design of AUTO1/22 with its high sensitivity CD22 Kymriah antigen receptor and the efficient core targeting leveraging Obe-cel's CD19 Kymriah antigen receptor. Turning to Slide 5 and other pipeline updates. We're looking forward to updating the progress with the AUTO4 peripheral T-cell lymphoma program in an oral presentation at the International Conference for Malignant Lymphoma in Lugano, Switzerland in June as well. Finally, we continue to enroll patients into the CART Phase I trial of AUTO8 in multiple myeloma and expect first data at the end of this year and expect to dose the first patient into Phase I trial of AUTO6NG in Neuroblastoma this year as well. Turning now to Slide number 6. With continued progress against our strategic and operational goals throughout the quarter. The company's new 70,000 square foot commercial manufacturing facility in Stevenage in the UK has continued to progress on track. Key equipment installation and validation were completed by Autolus in the first quarter of 2023, enabling operational qualifications commencing now in the second quarter of 2023. This facility will have an initial capacity of up to 2,000 batches per year, sufficient to serve the global demand in adult ALL. Just 18 months from groundbreaking, we are now working on the qualification and validation of the Nucleus facility and remain on track for good manufacturing practice operations commencing in the second half of this year. We're also undertaking the development work and report generation for the CMC package planned to support a BLA submission to the FDA. Our industry-leading cell programming platform creates opportunities for collaboration and licensing through our relationships with BMS and Moderna. We added in Q1 a partnership with Cabaletta, granting them access to our proprietary RQR8, rituximab-induced safety switch for incorporation into better selected cell therapy programs. In January, we also announced two changes to the Board of Directors. The company's non-executive Chairman, John Johnson, who has held the role since September '21, will not stand for reelection at the Autolus upcoming Annual Shareholder Meeting. Additionally, at the end of February, Dr. J. Backstrom, who had served on Autolus' Board of Directors since August 2020, stepped down from the Board after taking on a public CEO role at Scholar Rock. We also announced a change to our management team with Dr. Lucinda Crabtree, our CFO, also on the line today, planning to step down in August 2023 to pursue a new opportunity. Searches for successors for these posts are underway. Finally, total cash and cash equivalents and restricted cash at the end of March were $343.4 million. We've had a diversified treasury approach in place, which served us well during the Silicon Valley Bank incident, and we continue to diligently monitor developments in the financial sector. Moving on to Slide number 7. There are also several post-period events I'd like to bring to your attention. Last week, we announced that we had selected Cardinal Health as a core distributor for Obe-cel, giving us the platform and distribution capabilities required to commercialize a CAR-T cell therapy in the U.S. Cardinal Health's innovative depot model is intended to reduce delivery time by allowing for transit while the product release is being finalized. Alongside this, we continue to build out Autolus’ own commercial infrastructure and are working towards onboarding the clinical centers over the course of this year. Also, last week, we held a virtual Capital Markets Day that presented the positioning and commercial opportunity for Obe-cel. The event started with Professor Lori Muffly from Stanford University, reviewing the disease therapeutic options and medical need for adult patients with acute lymphoblastic leukemia. Professor Claire Rode from UCL then introduced Obe-cel's initial clinical experience in patients with ALL, followed by a video presentation of one of her patients and her experiences of living with an ALL diagnosis as well as her experience with the treatment regimen. With this deeper understanding of the physicians' and patients' views of this challenging disease, Dr. Matthew Gitlin talked about the ALL market and the prospective payers are taking. In particular, he looked at the cost of patient management and the impact on hospitals and payers, highlighting the substantial impact on the cost of managing high-grade cytokine release syndromes and ICANS. Finally, Chris Van, Autolus' Chief Operating Officer, walked through the commercial roadmap for Obe-cel. We believe it was a very informative and well-attended event. For anyone who missed it, a replay is on the Events section of the Autolus website available to you. Finally, we recently announced the publication of two papers, the first of which included the publication of the preclinical data for AUTO1/22 in Molecular Therapy, which I mentioned earlier, and the second published in Molecular Therapy Nucleic Acids focused on a new set of self-programming modules based on novel Fas-TNF receptor chimeras. This technology converts a threat to the CAR-T cell into an activating or survival signal instead. We're borrowing here from a martial arts principle of taking an incoming blow and rolling with it. Moving to Slide 8, Obe-cel. With that, I also am moving forward to Slide 9. Obe-cel has a unique mechanism of action. What's fundamentally different about our product candidate is that it has an ability to engage with the target cells, rapidly binding to the target, which delivers specificity paired with a fast offering for rapid disengagement from the target once the cell kill has been delivered. This unique engagement drives maximum activity while minimizing toxicity and is at the heart of the differentiated clinical profile we are observing for Obe-cel in ALL and non-Hodgkin's lymphoma. Moving to Slide 10. Our clinical experience with Obe-cel in ALL shows a high overall response rate across all patient populations evaluated. In our prior ALLCAR19 study, we have 35% of patients in long-term remission at 36 months of median follow-up with a range of 24 months to 48 months after receiving Obe-cel and without receiving any further anti-leukemia therapy. The safety profile is well manageable with low levels of high-grade cytokine release syndrome and ICANS. The mid-section of the slide shows the patients with long-term remissions have a continued presence of CAR T cells over the entire observation period, pointing to CAR T cell persistence as an indicator for long-term outcome. The program is developed under RMAT, Prime, and ILAP designation. Moving to Slide 11. We've now completed the enrollment and dosing of our pivotal study, which we call the FELIX study in adult patients with relapsed/refractory ALL. As I mentioned, we announced in December that we have met the primary endpoint based on the overall response rate at an interim analysis of the first 50 patients followed for at least three months. Clinical benefit in ALL will be assessed based on patients remaining in sustained complete remission. We conducted this study in 34 centers, 24 centers in the U.S., seven centers in the UK, and three centers in Spain, enrolling patients from July 2021 to November 2022 during the peak infection period of the pandemic. It's important to realize that relapsed/refractory adult ALL patients are highly immune-suppressed, and the pandemic posed significant added risks to them. Moreover, due to access restrictions and various other pandemic rules and regulations, we could not access our clinical trial sites for most of the FELIX study. This is a difficult population to work with, as you can imagine, particularly in an environment where there is a high risk of infection. And indeed, we did lose a few patients to COVID-19. In many ways, this was more of a real-world study conducted under difficult circumstances. In addition to patient safety, every aspect of product delivery and logistics were pressure-tested during the trial with massively reduced air traffic and other impacts of the pandemic and our manufacturing teams. Remarkably, manufacturing for all patients from our facility in the UK turned out to be an asset also for U.S. delivery as the long-haul flights from the U.S. to the UK have priority over domestic flights. We're pleased that we got it done under such challenging circumstances, and credit to our patients and their caregivers, clinical collaborators, and the whole Autolus team for this achievement. As mentioned earlier, the next key data is planned in oral presentations at ASCO and EHA in early June 2023. Moving to Slide number 12. This slide summarizes the announcement we made in December regarding the prespecified interim analysis of the first 50 out of 90 patients dosed and who have reached at least three months of follow-up. The primary endpoint is based on overall remission rate, which includes patients in complete remission and patients in complete remission with incomplete bone marrow recovery or CR and CRI. The ORR was 70%, as all recent programs in ALL have used ORR as the primary endpoint in their respective studies. Safety analysis was conducted on a larger 92 patient data set and showed an excellent profile with high-grade cytokine release experience in less than 3% of patients and high-grade ICANS in less than 8%. ICANS are fully reversible, and less than 25% of patients had any grade of neurotoxicity. In contrast to approved T-cell or T-cell engaging therapies, this is a very unusual profile in this patient population. And as I mentioned earlier, the data triggered a $35 million milestone from Blackstone. Moving to Slide 13. This slide summarizes our current experience with Obe-cel across ALL. As you can see, the data are highly consistent across the various studies, both on safety and efficacy. Worth noting is that CARPALL and ALLCAR were conducted prior to the pandemic, while both parts of the FELIX study were conducted during the pandemic. Both the CARPALL and ALLCAR19 studies were conducted in the UK, while the FELIX study was largely conducted in the U.S. What we did pick up is that patients in the FELIX study were more advanced in their disease based on tumor burden and increased presence of so-called extramedullary disease. This, in essence, is again a function of the leukemia that allows it to leave the bone marrow and settle and grow in other organs. Patients with extramedullary disease respond poorly to anti-leukemia therapies. Moving to Slide 14 to look at further into the data we presented at ASH from the ALLCAR19 study. When we look into the ALLCAR long-term observation from the ALLCAR19 study, where we have up to four years of follow-up, you can see the unusual and quite an unusual profile. We could see that clinical benefit in these patients is the ability to convert patients into complete remission and sustain them over time without additional therapy. And as you can see, obviously, a substantial proportion of the patients are indeed in sustained therapy. So if you go from bottom up, you can see at the bottom patients that obviously did not respond. We have then a group of patients that did respond and had relapsed quickly, including patients that have lost the CD19 antigen, with then a group of patients that actually relapsed with CD19-positive disease, those are patients that have lost persistence of the CAR-T product. And then there is the top group with long green survival lines, where you can see patients that actually have continued remission. In fact, those are also patients that have continued presence or persistence of CAR-T cells. Overall, this gives us a lot of confidence in terms of the consistency of the data, understanding the reasons when patients actually do relapse and the causes for that relapse are, and obviously the proportion of patients that are in ongoing remission without any additional therapeutic need. Turning to Slide 15. I thought it might help here to give you an overview of the ALL treatment landscape as it stands. The figure on the right represents the NCCN guidelines for the treatment of relapsed/refractory ALL. You can see it splits into two main arms. The lower arm actually looks at T-cell lymphoma, which is a subset and relatively small group of patients, and the upper two arms actually include B-cell lymphoma, specifically B-cell acute lymphoblastic leukemia. This is the disease setting that we're focusing on. We can also see that there are three novel therapeutics that have been incorporated into that scheme over the past 10 years. The first is BLINATUMOMAB or Blincyto. This is a bispecific T-cell engaging anti-CD19 therapeutic antibody, given as a continuous intravenous infusion for 28 days per cycle, with these cycles being repeatable at two-week intervals. The patient starts at the hospital and is eventually discharged with a container or a bag for continuous delivery through a central port throughout the entirety of the treatment cycle. These bags are typically changed once a week by a nurse that visits the patients at home to support the therapy. While the product is very active, unfortunately, like all therapeutic options available for adult patients with ALL, it does not actually lead to long-term remissions — one of the fundamental challenges we have in the field, as we have active therapies, but we have a hard time converting those effects and responses into long-term remissions. The next therapeutic we focus on is inotuzumab or Besponsa, an antibody conjugated drug therapy directed to CD22, which is expressed on most B-cells that can form ALL. This drug also has a very high response rate but is typically used as a bridge to transplant. Finally, the newest product is brexucabtagene or Tecartus, approved in 2021, which is the first CAR-T cell therapy approved for adult ALL patients. Both Blincyto and Tecartus leverage T-cell action but show similar immunological toxicities, namely CRS and ICANS, while inotuzumab can induce liver toxicity. Overall, it is clear we have a product that has a high level of clinical activity with a manageable safety profile, which is obviously attractive for all patients with ALL. If that product can also translate into at least a portion of patients achieving long-term remission, I believe that would represent a big step forward. Moving to Slide 16 to look at the data from these programs in the space. Blincyto, as I mentioned, is a T-cell engaging CD19 targeting monoclonal bispecific antibody that has become the standard of care in relapsed/refactory ALL over the last few years. The key to success has been its manageable safety profile. Key focus from a patient management perspective is the monitoring of ICANS, which impacts about two-thirds of patients. In contrast, if you look at Obe-cel, substantially more patients experience ICANS. As I mentioned before, we see about 25% of patients experiencing ICANS with Obe-cel. High-grade CRS for Blincyto is relatively low at around the 5% level, and Obe-cel seems to be similar or potentially slightly better. In contrast to Blincyto, Tecartus induces high-grade CRS in a substantially higher proportion of patients at 26%, with high-grade neurotoxicity reaching about 35%, while 87% of patients experience neurotoxicity of any grade. This presents a challenging safety profile often requiring ICU access. When we look at inotuzumab, the program has liver toxicity and is primarily used to bridge to transplant. None of these therapies have established long-term remissions without subsequent stem cell transplant. Moving to Slide 17. The market opportunity in ALL remains unchanged. As we haven't seen any significant move towards long-term remissions, we still see around 3,000 patients in high medical need of therapy between the U.S., Europe, and Japan. Moving to Slide 18. When we look at the actual size of the market, we always look for suitable surrogates, and we believe that the sales of Blincyto provide a strong reference for our product. First, Blincyto has a similar mechanism of action, being CD19 T-cell engaging agents. Second, it’s used largely in the same indication with somewhat higher levels of CRS and ICANS. About 80% of Blincyto revenue comes from adult ALL, with approximately 20% coming from pediatric ALL. Importantly, Blincyto's safety profile allows its use in a broad range of centers, not just in academic transplant centers. Blincyto had a record quarter in Q1, achieving a 41% year-over-year increase, with sales reaching $194 million in the first quarter. If we prudently assume quarterly sales remain constant with no further growth, we estimate full-year sales could reach approximately $800 million, indicating a year-over-year growth of about 33%. This highlights the meaningful commercial opportunity in adult ALL, driven by the manageable safety profile of Blincyto, and we report that the increase is attributable to an expansion of treatment centers. We are also seeing that many CAR-T centers are expanding their capacity for delivering CAR-T cell therapy. Both Blincyto and ultimately Obe-cel have the potential to be used in a broader array of hospitals. Prices for CAR T therapy in the U.S. are in the range of $450,000 to $500,000. Moving to Slide 19. As we look forward, first, we plan to disclose the FELIX data in oral presentations at ASCO and also EHA; long-term follow-up and additional sub-analyses are planned for ASH. We're targeting a BLA submission for the program towards the end of this year and an MAA filing towards the end of the first quarter of 2024, as well as a UK filing in the second quarter of next year. This sets up very nicely for the key territories we expect to be initially active in. In addition to the mature clinical data, the submission will also require data from the validation of our commercial manufacturing site. This work has been a key focus throughout the first half of 2023 and will continue into the third quarter. Our commercial manufacturing facility is set up to cover supply for approximately two-thirds of the estimated market from the start. We’ve also talked about selecting Cardinal Health as our U.S. distribution partner, which is an important step. As we move through 2023, we need to prepare key areas for commercialization. We're creating awareness for the program through a focused medical affairs program. Additionally, we are establishing the value proposition for payers in our HDA dosage and preparing for and starting the center onboarding process that will take between nine to 15 months to get each vendor ready to deliver CAR-T therapy. Moving to Slide 21 to discuss the broader opportunity we see with Obe-cel. As part of the ALLCAR extension study, we've been evaluating Obe-cel in relapsed/refractory non-Hodgkin's lymphoma and CLL patients. We consistently see very high response rates, combined with an attractive safety profile suitable for outpatient use. This data will support the selection of the second indication after ALL. In terms of the life cycle, we're working on the next-generation version of Obe-cel with Auto122, aiming to minimize CD19 antigen loss in relapses with this dual targeting approach. Building on Obe-cel, we are adding a highly potent CD22 CAR that can recognize very low amounts of CD22 on leukemia cells' surfaces. This program was initially evaluated in children who had failed Kymriah therapy or were not eligible. In this challenging population, we saw an 83% molecular response rate, including patients who had CD19 negative disease, demonstrating the efficacy of the CD22 CAR alone. Among responding patients, with a median follow-up of 8.7 months, there have been no cases of leukemic relapse or emergence of MRD related to antigen escape, indicating that combining our optimized CD22 CAR design with the CD19 CAR used in Obe-cel may effectively prevent antigen loss-driven relapse in pediatric CLL. We're working on further streamlining the manufacturing process for Auto1/22, knowing we have an attractive life cycle option. Timing of investment decisions will balance between Auto1/22 and additional investments for Obe-cel. Switching gears and heading to Slide 23. Our technology platform enables us to engineer a range of properties into T-cells that drive specificity of recognition, resilience against negative signals from tumor cells, and provide survival signals for T-cells. Our strength in T-cell engineering drives our pipeline and forms the foundation of the three collaborations I have mentioned, which were reported on in 2022 and early '23. On Slide 24, we have a quick summary of our earlier-stage programs in T-cell lymphoma with AUTO4/5, AUTO6NG neuroblastoma, AUTO8 multiple myeloma. AUTO4 and AUTO8 are in Phase I clinical trials, and AUTO6NG is expected to start during the course of the year. Moving to Slide 25. T-cell lymphoma represents a very high medical need, similar to ALL. In fact, when you look at the NCCN guidelines, it states that once you're through the frontline therapy and relapse, you must look for a clinical trial. Moving to Slide 26. With its unique targeting approach, AUTO4 is starting to show meaningful clinical impact at the higher dose levels we explored. The first metabolic CRs are reaching one year post-treatment, and we continue to follow the patients. In addition, we have streamlined the manufacturing process and explored activity in an additional cohort. We are planning to report data at the ICML Conference in June. Moving to Slide 28 to talk about manufacturing. Cell manufacturing is at the core of any autologous cell therapy. Developing a highly reliable, robust, and economical process is critical for the success of any program. Additionally, we must deliver a product at scale, matching capacity to the size of medical need, which is essential for successful rollout of any therapy. Building on the robust and well-characterized process used to manufacture for the FELIX clinical study, we're setting up our commercial cell manufacturing facility, called the Nucleus, about a mile away from the clinical trial manufacturing plant. This proximity is crucial as we can move our entire staff to the new facility, with many of our employees already engaged in the validation of the Nucleus facility. The capacity of the nucleus and its initial setup reaches 2,000 patient batches per year or about two-thirds of the adult ALL market size. The Nucleus has been a fantastic project to realize, with innovative design and about 75% off-site building to accelerate the construction while maximizing quality. Moving to Slide 29, which introduces the financial section. With that, I would like to turn to Slide 30 and pass the call over to Lucy for our Q1 2023 financial update. Lucy?

Lucinda Crabtree, CFO

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the first quarter ended March 31, 2023. The cash and cash equivalents and restricted cash at March 31, 2023, totaled $343.4 million, compared to $382.8 million at December 31, 2022. Net total operating expenses for the three months ended March 31, 2023, were $43.1 million, net of license revenue of $1.3 million, compared to net total operating expenses of $41.8 million, net of grant income of $0.2 million for the same period in 2022. Research and development expenses decreased by $2.7 million to $31.3 million for the three months ended March 31, 2023, from $34 million for the same period in 2022, primarily due to a decrease of $5.5 million in clinical trial and manufacturing costs, offset by an increase of $0.8 million in manufacturing material costs due to increased validation activities for Obe-cel, a decrease of $0.2 million in depreciation and amortization related to property, plant, and equipment and intangible assets, a decrease of $0.1 million in legal and professional consulting fees related to our research and development activities, an increase of $1.4 million in salaries and other employment-related costs, and an increase of $0.7 million related to information technology infrastructure and support for clinical trial and manufacturing operations; finally, an increase of $0.2 million in facilities costs related to our new manufacturing facility, the Nucleus. General and administrative expenses increased by $1.3 million to $9.3 million for the three months ended March 31, 2023, from $8 million for the same period in 2022, primarily due to the following: an increase of $0.7 million in salaries and other employment-related costs, an increase of $0.7 million in commercial readiness costs, and an increase of $0.1 million in general office supplies and expenses. For the three months ended March 31, 2023, we recognized a loss on disposal of property and equipment of $3.8 million related to fixed assets no longer used in the manufacturing facility exited in Stevenage, UK. No such disposals occurred for the three months ended March 31, 2022. Other income net decreased to $0.8 million from $0.9 million for the three months ended March 31, 2023, and 2022, respectively. The decrease of $0.1 million is primarily due to the recognition of lease termination loss from exiting one of our manufacturing suites in Stevenage, UK. Interest income increased to $3.4 million for the three months ended March 31, 2023, compared to $28,000 for the same period in 2022, relating to the increase in interest rates on our interest-bearing bank accounts and short-term investments. Interest expense increased to $4.9 million for the three months ended March 31, 2023, compared to $1.8 million for the same period in 2022. Interest expense is primarily related to the liability for future royalties and sales milestones associated with our strategic collaboration agreement with Blackstone. Net loss attributable to ordinary shareholders was $39.8 million for the three months ended March 31, 2023, compared to $37.1 million for the same period in 2022. The basic and diluted net loss per ordinary share for the three months ended March 31, 2023, totaled $0.23 compared to a basic and diluted net loss per ordinary share of $0.41 for the same period in 2022. Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the company's runway into 2025. With that, I'll hand it back to Christian to give you a brief outlook on expected milestones.

Christian Itin, CEO

Thanks, Lucy. Moving to Slide 32. To summarize, we think we have an exciting time ahead of us. The key focus is on getting Obe-cel into the regulatory process with the BLA filing targeted towards the end of the year, followed by filings in Europe in the first half of next year. Next, our planned FELIX presentation, followed by data presentations at ASCO and EHA. Additionally, we're preparing for commercial product supply and launch readiness. We expect to provide updates on the pipeline programs with additional data and follow-up during the year with our key programs, which are currently unpartnered and create opportunities for collaborations. Moving to Slide 33. We have the cash to deliver a significant value step. We have data that show Obe-cel has a differentiated product profile addressing a high medical need with limited competition, potentially leading to transformational outcomes. Alongside that, we have additional opportunities for Obe-cel and broader indications and a valuable pipeline for other oncology programs. We're excited about our manufacturing facility and have a strong technology foundation validated by our collaborators, BMS, Moderna, and Cabaletta, which recognize the value of our technology platform, enabling us to monetize this value via functional exercise fees and milestone payments. Importantly, we aim to forge more deals of this nature in the future. With that, I would like to thank you for listening to our prepared remarks. We are happy to take questions.

Operator, Operator

Thank you. Please stand by while we compile the Q&A roster. Our first question comes from Mara Goldstein with Mizuho. Mara, your line is open. Please go ahead.

Mara Goldstein, Analyst

Great. Thanks so much for taking the question. So a couple of things. One is, I'm just curious about the data disclosure on FELIX at ASCO versus EHA and will there be anything that's different or incremental at EHA? And then, on the AUTO8 program and data expectation for data this year, can you speak to what the totality of that could look like? How many patients you might have data on?

Christian Itin, CEO

Yeah. First off, thanks a lot for joining, Mara, and thanks for the question. The data that we're planning to release at ASCO, EHA are similar overall. What we're currently looking into is to evaluate certain additional sub-analysis that could be included in the EHA presentation. The data cut for the two presentations is the same since they are a few days apart, but there will be slight differences in some of the sub-analyses we plan to discuss. In terms of the flow of data, we have enrolled a little over 90 patients, which we will be reporting on, and that gives us a good understanding of the overall profile of the product and serves as a good first look in terms of follow-up. By the end of the year, we'll be able to add about six months of follow-up, which should provide further insight into the product's trajectory.

Mara Goldstein, Analyst

Okay. And then if I could just ask, since you included it in the news flow on the pipeline under collaboration, anything specifically related to the current collaborators that you think might occur in this year or is this a reference to potential new collaborations?

Christian Itin, CEO

I think we'll keep that open. Both outcomes are possible.

Mara Goldstein, Analyst

Okay. Thanks.

Christian Itin, CEO

Thanks, Mara.

Operator, Operator

And our next question comes from Matthew Phipps with William Blair. Matthew, your line is open. Please go ahead.

Matthew Phipps, Analyst

Thanks for taking my call and question. The AUTO immune indication is obviously pretty interesting in Novartis and Bristol talked this up pretty significantly last week during their own earnings calls, planning to move a kind of more rapid manufacturing process of their CAR-Ts into those indications. Do you think you'll take Obe-cel as is into the autoimmune field, or would you look to possibly add safety modules in case of adverse events in that population? Do you have thoughts on what the ideal durability of a CAR-T is in an autoimmune disease? Is this something where you need consistent application, or is it more of a reset of the immune system?

Christian Itin, CEO

Very good questions, Matt, and thanks for joining. We have always been monitoring the team in Erlangen closely and have had the opportunity to review their data. What we're seeing is a promising profile in terms of resetting the autoreactive B-cell compartment for a number of ways that can be beneficial. However, there's still vital follow-up is needed to assess the longevity of this effect. While B-cells may eventually return, autoreactive B-cells seem to have a long-term range as of the data seen so far. Determining the ideal duration of CAR-T application varies based on the individual case considerations, but sustained B-cell aplasia could be crucial. It is still early days to provide a specific timeframe, and we continue to watch and evaluate this space closely. Regarding the design of the product, we believe it fits well with its safety profile demonstrated across various challenging patients, and that positions us strongly in the setting. We also see the need for efficient manufacturing capabilities at reasonable cost levels for Obe-cel.

Matthew Phipps, Analyst

Thanks, Christian. And I have one quick follow-up. For the AUTO4 update at ICML, will that include the full cohort of patients treated with the streamlined manufacturing process?

Christian Itin, CEO

Probably not the full cohort at this point, but there will be additional updates, including longer follow-up of the patients and some translational data that should be helpful for understanding the trial's progress. All right. Thanks a lot, Matt.

Operator, Operator

Please stand by for our next question. And our next question comes from Yanan Zhu from Wells Fargo Securities. Yanan, please go ahead. Your line is open.

Yanan Zhu, Analyst

Hi. Thanks for taking our questions. You mentioned that the FELIX study was enrolled during the pandemic, which presented some challenges, such as patient loss to COVID-19. Did conducting the study during the pandemic impact the response rate or duration of response and other metric endpoints? Did the second half of the enrolled population experience any differences in disease severity, such as extramedullary involvement compared to the first 50 patients in the interim analysis?

Christian Itin, CEO

Thanks a lot, Yanan. Those are insightful questions. As we've observed with the interim analysis, we have a high level of response and an excellent safety profile. Overall, the program has performed well amidst the challenges presented by the pandemic. However, the individual impacts of the pandemic on patient access, travel restrictions, and overall health are variables that we continue to analyze. It is premature to speculate but remains essential for our evaluations. We will conduct a thorough analysis and will present findings in detail at a later conference, most likely at ASH, providing a complete review.

Yanan Zhu, Analyst

Understood. Thanks for taking the questions.

Christian Itin, CEO

Thanks, Yanan.

Operator, Operator

Please stand by for our next question. And our next question comes from Gil Blum from Needham & Company. Gil, your line is open. Please go ahead.

Gil Blum, Analyst

Good morning, everyone, and thank you for taking my question. Regarding multiple myeloma, it seems that standards have become increasingly high. Given the early stage of your program, where do you see this treatment fitting in, and what’s the best strategy to advance it? Is there potential for going allogeneic in some way?

Christian Itin, CEO

Good question, Gil. It's an interesting field where much learning is taking place. We have remarkable data coming from approved programs in early-line therapy, which provides immense excitement. However, the gap between demand for therapy and actual delivery remains significant. This disconnect opens an avenue for additional programs to help serve the high demand. In terms of profile, we want a product with a well-managed safety profile that can be accessible in a broad range of centers rather than just academic ones. The age of the patients is also a consideration. There's yet to be observed whether initial outstanding activities translate into long-term outcomes. Evaluating AUTO8 for sustained presence of the product and the persistence may provide insights towards longer-term efficacy.

Gil Blum, Analyst

Thank you, Christian. That's very helpful. On AUTO4, is the company leaning toward the program as a company-sponsored effort or more akin to potential partnerships?

Christian Itin, CEO

Currently, we are very focused on delivering Obe-cel and establishing the initial infrastructure for its commercialization. This focus requires us to prioritize our efforts. While we’re excited about AUTO4, which shows potential, there's room for partnerships that could allow moving it more aggressively alongside our efforts with Obe-cel.

Gil Blum, Analyst

Thank you for taking my question.

Christian Itin, CEO

Thanks a lot, Gil. Appreciate it.

Operator, Operator

Standby for our next question. Next, we have Kelly Shi with Jefferies. Kelly, your line is open. Please go ahead.

Kelly Shi, Analyst

Thank you for taking my question. For AUTO1 CD22, could you elaborate on Kymriah therapy exclusion criteria? Do you find the post-CD19 CAR market attractive for AUTO1 CD22? Additionally, we see two new targeting programs targeting CD19 CD20 running trials in post-CD19 settings. How do you compare CD20 and CD22 as targets for CAR-T therapy indicating CD19 relapse?

Christian Itin, CEO

Very good questions, and thanks for joining, Kelly. For AUTO1/22, patients defined as Kymriah-ineligible are those who have failed Kymriah therapy and patients with isolated extramedullary disease, along with those in too poor condition for therapy. These patients are deemed truly refractory, and we expect that if treated with Obe-cel, we might convert some to CR but not close to the 83% we’ve observed in this study. Regarding dual targeting approaches, we prioritize CD22 due to its presence in early stages of leukemia and the challenge posed by therapeutic pressures on CD20. The CD22 CAR in our tests has shown promise, particularly with responses seen in patients who also had CD19 negative disease.

Kelly Shi, Analyst

Very insightful. Thank you.

Christian Itin, CEO

Thank you.

Operator, Operator

Thank you very much, and stand by for our next caller. And our next question comes from Asthika Goonewardene at Truist. Asthika, your line is open. Please go ahead.

Asthika Goonewardene, Analyst

Hi, guys. Thanks for taking my questions. I want to dig into the comparison you've given on the number of centers for Blincyto versus those for Obe-cel. Given the initial focus on transplant centers, could you detail your commercialization strategy and what your anticipated sales force size should be?

Christian Itin, CEO

Thanks for joining, and it's an interesting question. BLINCYTO launched primarily in transplant centers within the U.S. and Europe, around 60 centers treated the majority of these advanced disease patients. For us, the initial core will focus on those 60 centers where we have gained experience with the product. However, we also aim to increase accessibility in non-academic centers with proper patient management. Our safety profile significantly aids in this strategy. Significant expansion could include treating lower disease burden patients in non-academic transplant centers, reducing risk and facilitating access. Our commercial organization could initially range between 120 to 150 personnel to effectively support these centers.

Asthika Goonewardene, Analyst

Thank you, Christian. Quick one on ASCO — what proportion of patients from the 50 in the efficacy analysis will have six months of follow-up? Any insights into potential sub-analyses at EHA as well?

Christian Itin, CEO

Around eight to nine months of median follow-up of all patients will be close by ASCO. Specifics on sub-analyses for EHA are still being finalized.

Asthika Goonewardene, Analyst

Okay. Appreciate the color. Thanks so much.

Christian Itin, CEO

Thank you.

Operator, Operator

That concludes our Q&A for today. I would now like to turn it back to Dr. Christian Itin, Chief Executive Officer, for closing remarks.

Christian Itin, CEO

Thank you for joining today. It's fantastic to have all of you participate and I look forward to seeing you at upcoming conferences later this summer. If not, I hope to visit your respective areas soon. With that, I conclude this call. Thank you for your time, and I look forward to providing updates at ASCO in a few weeks' time.

Operator, Operator

Thank you very much for your participation. This does conclude our program. You may now disconnect.