Financial Data and Key Metrics Changes - Cash and cash equivalents increased to $657.1 million as of September 30, 2024, compared to $239.6 million at the end of December 2023 [37] - Total net operating expenses for Q3 2024 were $67.9 million, up from $42.9 million in Q3 2023 [38] - Research and development expenses rose from $32.3 million to $40.3 million year-over-year [39] - General and administrative expenses increased significantly from $10.6 million to $27.3 million, primarily due to increased headcount for pre-commercialization activities [40] - Net loss for Q3 2024 was $82.1 million, compared to $45.8 million in the same period last year [41] Business Line Data and Key Metrics Changes - The approval of AUCATZYL is a significant milestone, marking the first CAR-T program approved without a REMS requirement by the FDA [7][8] - The company has onboarded approximately 60 centers for AUCATZYL, with 30 ready to activate, covering about 60% of the target patient population in the U.S. [11] - The commercial manufacturing facility, The Nucleus, is expected to produce approximately 2,000 products annually, targeting two-thirds of relapsed or refractory patients in the U.S. and Europe [14] Market Data and Key Metrics Changes - The price for AUCATZYL is set at $525,000, based on extensive evaluations of its clinical value and safety profile [19] - The company is actively engaging with regulatory authorities in Europe and the UK for the approval of obe-cel, with expectations for mid-2025 [21][46] Company Strategy and Development Direction - The company is focused on launching AUCATZYL and expanding its CAR-T therapy offerings, with plans to add 30 more centers in 2025 to reach approximately 90% of the target population [12] - The company is also exploring broader applications for obe-cel beyond ALL, including studies in pediatric patients and systemic lupus [29][30] - The strategy includes a country-by-country approach for the European launch, starting with Germany [85] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the approval of AUCATZYL and the potential impact on ALL patients [9][34] - The company anticipates initial data from the Phase 1 SLE trial by the end of Q1 2025, with further updates on pediatric ALL and long-term observations later in the year [43][35] - Management highlighted the importance of a strong safety profile for obe-cel, which may facilitate outpatient administration [47] Other Important Information - The company expects to receive a $30 million milestone payment from Blackstone due to the FDA approval, along with a £10 million regulatory milestone payment [42] - The company is preparing for presentations at the upcoming ASH meeting, with four abstracts selected for presentation [24] Q&A Session Summary Question: Is obe-cel's EU approval still on track for mid-25? - Management confirmed that the EU approval process is on track for mid-2025, with similar expectations for the UK [46] Question: Can you expand on the baseline characteristics that might suggest obe-cel's superior efficacy? - Management noted that patients with less than 75% tumor burden at lymphodepletion showed an ORR of 85-86%, indicating high efficacy [51] Question: How are you maintaining a low out-of-spec rate in a commercial setting? - Management expressed confidence in maintaining low out-of-spec rates due to established specifications based on clinical performance [57] Question: Can you discuss any feedback from physicians regarding Ticardis versus Obe-cel? - Management reported positive feedback on obe-cel's product profile, highlighting its easier management and lower toxicity [74] Question: Can you provide insights into the SLE trial patient numbers and data disclosure? - The SLE trial is enrolling six patients initially, with data expected in Q1 and longer-term follow-up in the second half of the year [78]

Autolus Q3 2024 Financial Results and Business Updates 12 November 2024 For Investor communication only. Not for use in product promotion. Not for further distribution. Autolus.com Disclaimer These slides contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "pl ...

Financial Results - Autolus Therapeutics plc announced its financial results for Q3 2024, ending September 30, 2024[4]. - The financial results and corporate updates are not deemed "filed" under the Securities Exchange Act[4]. Corporate Updates - The company provided a corporate update during the conference call held on November 12, 2024[5]. - A press release detailing the financial results was issued, which is included as Exhibit 99.1[6]. - An updated corporate presentation was utilized during the conference call, available as Exhibit 99.2[5]. - The report was signed by CEO Christian Itin, Ph.D., on November 12, 2024[7]. Company Information - The company is listed on the Nasdaq Global Select Market under the trading symbol AUTL[2]. - The nominal value of the ordinary shares is $0.000042 per share[2]. - Autolus Therapeutics plc is not classified as an emerging growth company[3]. - The company is based in London, United Kingdom[1].

Core Insights - The FDA has granted marketing approval for AUCATZYL (obecabtagene autoleucel), the first CAR T therapy without a REMS program, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - The approval is based on the results from the FELIX clinical trial, which demonstrated significant efficacy and safety profiles for AUCATZYL [2][4] Company Overview - Autolus Therapeutics plc is an early commercial stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases [7] - AUCATZYL is the company's first commercial product, marking a significant milestone in its development journey [4] Clinical Trial Results - In the FELIX trial, 94 patients received AUCATZYL, with 63% achieving overall complete remission (OCR) and 42% achieving complete remission within 3 months [2][22] - The median duration of remission was reported at 14.1 months, indicating long-term efficacy [2][4] Safety Profile - AUCATZYL showed low levels of Cytokine Release Syndrome (CRS), with only 3% of patients experiencing Grade 3 events, and no Grade 4 or 5 events reported [2][3] - The most common adverse reactions included infections, musculoskeletal pain, and neurologic toxicities, with 64% of patients experiencing some form of neurologic toxicity [3][23] Manufacturing and Distribution - AUCATZYL will be manufactured at Autolus' dedicated site in Stevenage, UK, which has received necessary regulatory approvals [4] - Cardinal Health will serve as the commercial distribution partner in the U.S. [4] Market Context - Approximately 8,400 new cases of adult ALL are diagnosed annually in the US and EU, with around 3,000 patients in the relapsed refractory setting, highlighting a significant unmet medical need [5] - The approval of AUCATZYL is expected to address the poor survival rates in adult patients with r/r ALL, which currently stands at a median overall survival of eight months [5]

LONDON, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will release its third quarter 2024 financial results and operational highlights before open of US markets on Tuesday, November 12, 2024. Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company’s financial results and provide a general business update. Conferen ...

kadirkaplan/iStock via Getty Images Investment Overview - Brife Cell Therapy Overview — Autolus' November PDUFA Date The list of approved cell therapies is growing every year, and potentially, Autolus Therapeutics plc (NASDAQ:AUTL), the United Kingdom based T-cell specialist could be the next to enter the commercial markets. As a reminder, “autologous” cell therapies work extraction a patients' cells, transportation to a lab, genetically engineer the cells to be able to target, attack and destroy, certa ...

Autolus Q2 2024 Financial Results and Business Updates 8 August 2024 Autolus.com Developing Next Generation Programmed T Cell Therapies Disclaimer These slides contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These st ...

Financial Data and Key Metrics - Cash and cash equivalents at the end of June 2024 totaled $705.9 million, compared to $239.6 million at the end of December 2023 [36] - Total net operating expenses for Q2 2024 were $58.9 million, up from $44.4 million in Q2 2023 [36] - Research and development expenses increased from $33.2 million to $36.6 million year-over-year, driven by manufacturing facility costs, employee salaries, and obe-cel clinical trial expenses [36] - General and administrative expenses rose from $11.1 million to $21.9 million, primarily due to increased headcount for pre-commercialization activities [37] - Net loss for Q2 2024 was $58.3 million, compared to $45.6 million in Q2 2023 [37] Business Line Data and Key Metrics - The company is progressing with regulatory reviews for obe-cel in the US, Europe, and the UK, with a PDUFA target date of November 16, 2024 [6] - Two Phase 1 clinical trials are ongoing: one in pediatric ALL and another in advanced-stage relapsed/refractory systemic lupus (CARLYSLE study) [6][7] - The pivotal FELIX study showed stabilization in event-free survival and overall survival, with 40% of responders in ongoing remission without subsequent therapy [8][14][20] - The company is preparing for commercialization, with 30-36 centers expected to be ready for activation by the time of approval, targeting 60 centers within the first year of launch [22][23] Market Data and Key Metrics - The company is focusing on the US market for obe-cel commercialization, with centers covering 65%-70% of the ALL population in the US [55][56] - The CARLYSLE study in systemic lupus erythematosus (SLE) is enrolling patients, with the first patient dosed in Q2 2024 [32] - The company is also exploring opportunities in autoimmune diseases, with plans to expand the AUTO8 program into additional indications [33][34] Company Strategy and Industry Competition - The company is strengthening its board with the addition of Mike Bonney as chair and Ravi Rao, an expert in autoimmune diseases, to support commercialization and expansion into adjacent indications [10] - The company is preparing for the launch of obe-cel, focusing on medical affairs, market access, and onboarding treatment centers [21][22] - The company is differentiating obe-cel through its unique CAR T-cell design, which provides rapid expansion and long persistence, leading to improved safety and efficacy profiles [48][49][76] Management Commentary on Operating Environment and Future Outlook - Management is focused on achieving regulatory approval and successful commercialization of obe-cel, with a strong emphasis on launch readiness and operational execution [39][61] - The company is well-capitalized to support the launch of obe-cel and advance pipeline development, including pivotal studies in autoimmune diseases [37] - Management highlighted the potential for obe-cel to serve as a standalone therapy, with no evidence that stem cell transplant consolidation improves outcomes [18][20] Other Important Information - The company has promoted several leaders to senior vice president roles, recognizing their contributions to regulatory, manufacturing, and market access efforts [12] - The company is collaborating with BioNTech, with ongoing discussions that may create additional opportunities beyond current visibility [61] Q&A Session Summary Question: Launch Timeline and Center Activation - The company clarified that the launch is not rolling but depends on center readiness, with activation timelines ranging from 2 to 12 weeks [42][43] - Centers covering 65%-70% of the ALL population in the US are already in the onboarding process, with 30-36 centers expected to be ready at approval [55][56] Question: Autoimmune Data Expectations - Initial data from the CARLYSLE study will focus on safety and short-term efficacy, with limited follow-up due to the early stage of the trial [45] Question: Costimulatory Domains and Safety - The company explained that obe-cel's design combines rapid expansion with long persistence, offering a unique safety and efficacy profile compared to other CAR T therapies [47][48][76] Question: Manufacturing and Delivery Time - The company is targeting a 16-day vein-to-delivery time at launch, with potential for further reduction, supported by faster analytics and logistics improvements [101] Question: Impact of Blincyto Approval on Relapsed/Refractory ALL - The company believes the impact of Blincyto's approval in frontline consolidation is already reflected in the market, with minimal effect on the relapsed/refractory setting [104][106] Question: Next Steps in Autoimmune Development - The company plans to provide updates on the next autoimmune disease target in Q1 2025, following the launch of obe-cel [89]

Financial Performance - For the three months ended June 30, 2024, the company incurred a net loss of $58.3 million, compared to a net loss of $45.6 million for the same period in 2023, representing a 28.9% increase in losses year-over-year[138]. - For the six months ended June 30, 2024, the company reported net losses of $111.0 million, up from $85.4 million in the same period in 2023, indicating a 29.9% increase in losses[138]. - The company reported a net loss of $58.3 million for Q2 2024, compared to a net loss of $45.6 million in Q2 2023, representing a 28% increase in losses[160]. - Net loss before income tax was $110.9 million for the six months ended June 30, 2024, a 30% increase from $85.3 million in 2023[175]. Cash and Liquidity - As of June 30, 2024, the company had an accumulated deficit of $989.5 million, compared to $878.6 million as of December 31, 2023[138]. - The company had cash and cash equivalents of $705.9 million as of June 30, 2024, which is expected to fund current and planned operating expenses for at least the next twelve months[138]. - Cash and cash equivalents as of June 30, 2024, totaled $705.9 million[183]. - As of June 30, 2024, the company had cash and cash equivalents of $705.9 million, up from $239.6 million as of December 31, 2023[201]. - The company expects its current cash and cash equivalents to be sufficient to fund operating expenses and capital expenditures for at least the next twelve months[192]. - Net cash used in operating activities was $91.6 million for the six months ended June 30, 2024, compared to $80.6 million in 2023[186]. - Net cash provided by financing activities was $559.4 million for the six months ended June 30, 2024, primarily from proceeds raised from BioNTech Agreements and an underwritten offering[189]. - Approximately 30% of the company's cash and cash equivalents were denominated in pound sterling and 70% in U.S. dollars as of June 30, 2024, highlighting the company's exposure to foreign currency risk[202]. - The company maintains significant amounts of cash in excess of federally insured limits, which are placed with financial institutions for varying periods[201]. Revenue and Income - The company has not generated any revenue from commercial product sales, with total revenue to date primarily from license agreements[142]. - License revenue for the six months ended June 30, 2024, was $10.1 million, a 681% increase from $1.3 million for the same period in 2023[172]. - Interest income surged to $9.7 million in Q2 2024, up from $3.4 million in Q2 2023, indicating a significant increase of 185% due to higher yields and account balances[168]. - Interest income increased by 142% to $16.6 million for the six months ended June 30, 2024, from $6.8 million in 2023[180]. - Other income (expense), net rose to $1.2 million in Q2 2024 from $0.5 million in Q2 2023, primarily due to favorable foreign currency exchange rates[167]. Expenses - Total operating expenses increased by 17% to $97.7 million for the six months ended June 30, 2024, compared to $83.5 million for the same period in 2023[175]. - Research and development expenses are expected to increase substantially over the next few years due to additional clinical trials and regulatory filings[149]. - Research and development expenses rose to $36.6 million in Q2 2024 from $33.2 million in Q2 2023, marking a 10% increase, primarily driven by clinical trial costs and increased salaries[159][163]. - Research and development expenses rose by 11% to $67.3 million for the six months ended June 30, 2024, up from $60.6 million in 2023[175]. - General and administrative expenses increased by 96% to $40.1 million for the six months ended June 30, 2024, compared to $20.4 million in 2023[176]. - Interest expense increased to $10.2 million in Q2 2024 from $5.0 million in Q2 2023, reflecting a 104% rise attributed to higher liabilities for future royalties and milestones[169]. - Interest expense surged by 197% to $29.4 million for the six months ended June 30, 2024, compared to $9.9 million in 2023[181]. - Direct research and development expenses for B cell malignancies increased by 86% to $7.7 million in Q2 2024 from $4.1 million in Q2 2023[161]. Clinical Development and Regulatory - The company’s obe-cel BLA for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia is on track for an FDA target action date of November 16, 2024[139]. - The pooled analysis of the FELIX Phase 1b/2 study showed that 40% of patients treated with obe-cel are in ongoing remission, with 99 responders noted[139]. - The company expects initial clinical data from the Phase 1 dose confirmation study in refractory systemic lupus erythematosus patients in late 2024[140]. - The company entered into a distribution services agreement with a subsidiary of Cardinal Health to support the ordering and distribution of obe-cel in the U.S. upon regulatory approval[141]. - The company anticipates incurring significant commercialization expenses if regulatory approval is received for its product candidates, including manufacturing, sales, and marketing costs[192]. Tax and Accounting - The company accumulated tax losses for carry forward in the U.K. amounting to $418.1 million as of December 31, 2023, with a valuation allowance recognized against the deferred tax asset[158]. - The company expects to benefit from U.K. R&D tax credits, with an increase of $1.8 million in credits due to qualifying expenditures under the SME scheme[163]. - A material weakness in internal control over financial reporting was identified related to the misinterpretation of ASC 740 regarding U.K. SME tax credits, which was remediated by June 30, 2024[204]. - The company identified a material weakness in internal controls related to accounting for complex transactions, which has been addressed through a remediation plan[203]. - The company has identified a second material weakness related to accounting for complex transactions, particularly concerning the BioNTech Agreements[203]. - There were no material changes in internal control over financial reporting during the three months ended June 30, 2024, except for the remediation processes described[204]. Foreign Exchange and Risk Management - The company recorded foreign exchange gains of $1.2 million for the three months ended June 30, 2024, compared to gains of $0.4 million for the same period in 2023[202]. - The company recorded foreign exchange losses of $0.5 million for the six months ended June 30, 2024, compared to gains of $1.3 million for the same period in 2023[202]. - The company has not engaged in currency hedging activities but may consider it in the future to manage foreign currency exposure[202]. - An immediate hypothetical one percentage point change in interest rates would have resulted in a $2.1 million increase in interest income for the year ended December 31, 2023[201].

Form 8-K Current Report [Results of Operations and Financial Conditions](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Conditions) The company announced its Q2 2024 financial results and corporate update, furnished as Exhibit 99.1, on August 8, 2024 - The company announced its financial results for the **second quarter ended June 30, 2024**, and provided a corporate update on **August 8, 2024**[4](index=4&type=chunk) - A copy of the press release was furnished as **Exhibit 99.1** and is incorporated by reference[4](index=4&type=chunk) - Information under this item is **furnished**, not **filed**, under Section 18 of the Exchange Act and not incorporated by reference unless explicitly stated[4](index=4&type=chunk) [Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) An updated corporate presentation, furnished as Exhibit 99.2, was used for the August 8, 2024, Q2 2024 results conference call - An updated corporate presentation was furnished as **Exhibit 99.2** for the **August 8, 2024**, conference call discussing **Q2 2024** results[5](index=5&type=chunk) - Information in this item is also **furnished**, not **filed**, for purposes of Section 18 of the Exchange Act[5](index=5&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits furnished with the Form 8-K report, including the Q2 2024 press release and corporate presentation Exhibit List | Exhibit No. | Description of Exhibit | | :--- | :--- | | 99.1 | Press release dated August 8, 2024 | | 99.2 | Corporate Presentation dated June 2024 | | 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document) |