Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 8, 2024

Autolus Therapeutics plc

(Exact name of registrant as specified in its Charter)


England and Wales	001-38547		Not applicable
(State or other jurisdiction of incorporation or organization)	(Commission File Number)		(I.R.S. Employer Identification No.)

The Mediaworks
191 Wood Lane
London		W12 7FP
United Kingdom
(Address of principal executive offices)(Zip Code)

(44) 20		3829 6230
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing one ordinary share, nominal value $0.000042 per share	AUTL	The Nasdaq Global Select Market
Ordinary shares, nominal value $0.000042 per share*	*	The Nasdaq Stock Market LLC*


*						Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Select Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8 thereunder.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Conditions.

On August 8, 2024, Autolus Therapeutics plc (the “Company”) announced its financial results for the second quarter ended June 30, 2024 and provided a corporate update. A copy of the press release is being furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

The information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 7.01 Regulation FD Disclosure.

In connection with its conference call on August 8, 2024 to discuss its results for the second quarter ended June 30, 2024, the Company will utilize an updated corporate presentation, a copy of which is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

d) Exhibits


Exhibit No.						Description of Exhibit

99.1						Press release dated Augus t 8 , 2024
99.2						Corporate Presentation dated June 2024
104						Cover Page Interactive Date File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


		AUTOLUS THERAPEUTICS PLC
Dated: August 8, 2024	By:	/s/Christian Itin, Ph.D.
		Name: Christian Itin, Ph.D.
		Title: Chief Executive Officer

Autolus Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates August 8, 2024 at 7:00 AM EDT On track for potential US commercial launch of obe-cel; PDUFA date November 16, 2024 Longer follow up and subset analyses from pivotal FELIX Phase 2 data presented at ASCO and EHA; majority of responders showed durable responses; 40% of patients in ongoing remission without subsequent stem cell transplant (SCT) or other intervention A Market Authorization Application (MAA) for obe-cel in relapsed/refractory r/r adult B-cell Acute Lymphoblastic Leukemia (B-ALL) was submitted to the Medicine and Healthcare products Regulatory Authority (MHRA) in the UK at the end of July 2024. The MAA review process continues with the European Medicines Agency (EMA) Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces its financial results for the second quarter ended June 30, 2024, and provides additional operation and clinical updates. “We are focused on driving commercial readiness activities across Autolus to bring our lead product obecabtagene autoleucel (obe-cel) to adult B-ALL patients. Applications for marketing authorizations are under review by regulatory agencies in the US, Europe and UK, and we are working towards a US Food and Drug Administration (FDA) PDUFA target date of November 16, 2024,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “Data from the FELIX Phase 1b/2 study with a median follow up of 21 months presented at ASCO and EHA indicate a long-term plateau forming in event-free and overall survival rates. Stem cell transplant post obe-cel did not appear to improve patient outcomes, and patients with long-term persisting obe-cel appear to have improved event free survival. The data support the potential for obe-cel as a stand-alone therapy in a portion of r/r adult ALL patients.” Key obe-cel updates and anticipated milestones: Obe-cel in r/r adult B-ALL – The FELIX Study In the UK, an MAA was submitted to the MHRA at the end of July 2024. The Biologics License Application (BLA) is on track with the FDA, working towards a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024. An MAA submitted to EMA was accepted in April 2024. Pooled analysis of the FELIX Phase 1b/2 study were presented at the American Society of Oncology (ASCO) and European Hematology Association (EHA) annual meetings in June 2024, with a median follow-up of 21 months. Data showed stabilization of event-free survival and overall survival following treatment with obe-cel, with 40% of patients in ongoing remission. Of the 99 responders following treatment with obe-cel, 18 received a subsequent stem cell transplant (SCT) while in minimal residual disease (MRD)-negative response but did not show improved survival compared to patients who did not have a subsequent SCT. Patients with prolonged obe-cel persistence experienced improved event-free survival and data indicate that bridging of high tumor burden patients with inotuzumab could be effective at reducing tumor burden, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) without increasing liver toxicity. Obe-cel in B-cell mediated autoimmune diseases The Phase 1 dose confirmation study (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients is ongoing. Autolus continues to expect initial clinical data in late 2024. Pipeline programs in collaboration with University College London Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing well and we are planning data updates for all programs in 2025. Operational Updates: During the quarter, Autolus promoted the following individuals to Senior Vice President: Andrea Braun, Regulatory Affairs; Markus Gruell, Corporate Quality; Claudia Mercedes Mayer, Manufacturing Strategy and Technology; Chris Gray, Technical Operations and Facilities and Dilip Patel, Market Access and Pricing Strategy. These individuals bring significant leadership experience and continue to drive Autolus’ regulatory activities and preparation for the potential commercialization and launch of obe-cel. In April 2024, Autolus announced that the EMA had accepted its MAA for obe-cel for patients with r/r adult B-ALL. EX-99.1

In April 2024, Autolus entered into a distribution services agreement with a subsidiary of Cardinal Health to support the ordering and distribution of obe-cel in the United States, if it receives regulatory approval. In April 2024, Autolus announced the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D. as Non-Executive Director. John H. Johnson stepped down from his roles as Chairman of the Board and Non-Executive Director, effective April 1, 2024. 2024 Expected News Flow: Obe-cel U.S. FDA PDUFA target action date November 16, 2024 Obe-cel FELIX data at American Society of Hematology (ASH) meeting December 2024 Obe-cel in autoimmune disease – initial data from SLE Phase 1 study Late 2024 Financial Results (Unaudited) for the Quarter Ended June 30, 2024 Cash and cash equivalents at June 30, 2024 totaled $705.9 million, as compared to $239.6 million at December 31, 2023. Total operating expenses, net for the three months ended June 30, 2024 were $58.9 million, as compared to $44.4 million for the same period in 2023. Research and development expenses increased from $33.2 million to $36.6 million for the three months ended June 30, 2024, compared to the same period in 2023. This change was primarily due to increases in operating costs related to our new manufacturing facility, employee salaries and related costs, and clinical trial and manufacturing costs related to obe-cel, partially offset by an increase in our U.K. reimbursable R&D tax credits that reduce R&D expense. General and administrative expenses increased from $11.1 million to $21.9 million for the three months ended June 30, 2024, compared to the same period in 2023. This increase was primarily due to salaries and other employment-related costs driven by increased headcount supporting pre-commercialization activities. Net loss was $58.3 million for the three months June 30, 2024, compared to $45.6 million for the same period in 2023. Basic and diluted net loss per ordinary share for the three months ended June 30, 2024, totaled $(0.22), compared to basic and diluted net loss per ordinary share of $(0.26) for the same period in 2023. Autolus estimates that, with its current cash and cash equivalents, it is well capitalized to drive the full launch and commercialization of obe-cel in r/r adult B-ALL as well as to advance its pipeline development plans, which includes providing runway to data in the first pivotal study of obe-cel in autoimmune disease. Financial Results for the Quarter Ended June 30, 2024 Selected Unaudited Condensed Consolidated Balance Sheet Data (In thousands) June 30 December 31 2024 2023 Assets Cash and cash equivalents $ 705,939 $ 239,566 Total current assets $ 758,600 $ 275,302 Total assets $ 853,620 $ 375,381 Liabilities and shareholders’ equity Total current liabilities $ 40,904 $ 44,737 Total liabilities $ 325,776 $ 263,907 Total shareholders' equity $ 527,844 $ 111,474 Selected Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss Data (In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 License revenue $ — $ — $ 10,091 $ 1,292 Operating expenses: Research and development (36,612) (33,232) (67,283) (60,620) General and administrative (21,903) (11,122) (40,080) (20,406) Loss on disposal of property and equipment — (23) — (3,791) Impairment of operating lease right-of-use assets and related property and equipment (414) — (414) — Total operating expenses, net (58,929) (44,377) (97,686) (83,525)

Total other income (expense), net 708 (1,135) (13,233) (1,812) Net loss before income tax (58,221) (45,512) (110,919) (85,337) Income tax expense (51) (40) (43) (26) Net loss (58,272) (45,552) (110,962) (85,363) Other comprehensive income (loss): Foreign currency exchange translation adjustment 1,026 5,300 1,084 10,941 Total comprehensive loss $ (57,246) $ (40,252) $ (109,878) $ (74,422) Basic and diluted net loss per ordinary share $ (0.22) $ (0.26) $ (0.43) $ (0.49) Weighted-average basic and diluted ordinary shares 266,025,783 173,860,491 255,131,873 173,843,249 Conference Call Management will host a conference call and webcast at 08:30 am EDT/13:30 pm BST to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website. About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com About obe-cel (AUTO1) Obecabatagene autoleucel (obe-cel) is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. In clinical trials of obe-cel, this “fast off-rate” profile reduced toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in relapsed/refractory (r/r) Adult B-cell Acute Lymphoblastic Leukemia (B-ALL) patients. The results of the FELIX trial, a pivotal trial for adult B-ALL, have been submitted and accepted by the FDA with a PDUFA target action date of November 16, 2024. In the EU a regulatory submission to the EMA was accepted in April 2024, while in the UK, an MAA was submitted to MHRA in July 2024. In collaboration with Autolus’ academic partner, University College London, obe-cel is currently being evaluated in a Phase 1 clinical trial for B-cell non-Hodgkin lymphoma (B-NHL). About obe-cel FELIX clinical trial Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint was overall response rate, and the secondary endpoints included duration of response, MRD negative complete remission rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660] About AUTO1/22 AUTO1/22 is a novel dual targeting CAR T cell-based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust expansion and persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase 1 clinical trial for patients with r/r pediatric ALL. [NCT02443831] About AUTO6NG AUTO6NG is a next generation programmed T cell product candidate in development for the treatment of both neuroblastoma and other GD2-expressing solid tumors. AUTO6NG builds on preliminary proof of concept data from AUTO6, a CAR targeting GD2-expression cancer cell currently in clinical development for the treatment of neuroblastoma. AUTO6NG incorporates additional cell programming modules to overcome immune suppressive defense mechanisms in the tumor microenvironment, in addition to endowing the CAR T cells with extended persistence capacity. A Phase 1 clinical trial of AUTO6NG in children with relapsed/refractory neuroblastoma was opened for enrollment in the fourth quarter of 2023. About AUTO8 AUTO8 is a next-generation product candidate for multiple myeloma which comprises two independent CARs for the multiple myeloma targets, B-cell maturation antigen (BCMA) and CD19. We have developed an optimized BCMA CAR designed for improved killing of target cells that express BCMA at low levels. This has been combined with fast off rate CD19 CAR from obe-cel, with the aim of inducing deep and durable responses and extending the durability of effect over other BCMA CARs currently in development. This product candidate is currently in a Phase I clinical trial for patients with r/r multiple myeloma. [NCT04795882] Forward-Looking Statements This press release contains 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 statements include, but are not limited to, statements regarding Autolus’ development and commercialization of its product candidates, timing of data announcements and regulatory submissions, its cash resources and the market opportunity for obe-cel. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing

and results of clinical trials;that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release. Contact: Olivia Manser +44 (0) 7780 471 568 o.manser@autolus.com Julia Wilson +44 (0) 7818 430877 j.wilson@autolus.com Susan A. Noonan S.A. Noonan Communications +1-917-513-5303 susan@sanoonan.com

Q2 2024 Financial Results and Business Updates 8 August 2024 Autolus.com EX-99.2

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 statements include, but are not limited to, statements regarding Autolus’ development of its product candidates, including the obe-cel program; the profile and potential application of obe- cel in additional disease settings; the future clinical development, efficacy, safety and therapeutic potential of the Company’s product candidates, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical and preclinical activity and milestones; expectations regarding the initiation, design and reporting of data from clinical trials and preclinical studies; the extension of the pipeline beyond obe-cel; expectations regarding the regulatory approval process for any product candidates; the benefits of the collaboration between Autolus and BioNTech, including the potential and timing of milestone payments and royalties under the terms of the strategic collaboration; the Company’s current and future manufacturing capabilities; and the Company’s anticipated cash runway. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the Securities and Exchange Commission. All information in this presentation is as of the date of the presentation, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this presentation. Developing Next Generation Programmed T Cell Therapies 2

Agenda 3 Developing Next Generation Programmed T Cell Therapies • Welcome and Introduction: Olivia Manser, Director, Investor Relations • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr. Christian Itin and Rob Dolski

Autolus executed to plan in Q2 2024 Developing Next Generation Programmed T Cell Therapies 4 Clinical Operational • Obe-cel progressing according to plan – FDA PDUFA target date of November 16 – MAA submitted to MHRA in Q3; MAA accepted by EMA – SLE Phase 1 CARLYSLE study first patient dosed in Q2, enrolment ongoing • Further FELIX Phase 2 data presentation at ASCO and EHA – Longer f/u for FELIX study – potential for long-term plateau of survival outcomes – Stem cell transplant consolidation does not appear to improve EFS or OS – Ongoing CAR T persistence appears associated with improved EFS – Impact of inotuzumab-based bridging therapy • Strengthened of board of directors and promotions within senior leadership team – Announced Mike Bonney as new chair and Ravi Rao as a new director of the board – Recognizing their leadership and contributions several leaders across regulatory, commercial and product delivery areas have been promoted to SVP: Andrea Braun, Chris Gray, Markus Gruell, Claudia Mercedes Mayer and Dilip Patel

ASCO/EHA 2024 OBE-CEL IN ADULTS WITH R/R B-ALL FELIX Phase 1b/2 trial

FELIX study all cohorts: Majority of responders show durable response (n=127) Developing Next Generation Programmed T Cell Therapies 6 40% of responders are in ongoing remission without consolidative SCT and 18% had consolidative SCT CR or CRi n = 99 (78%) Infused N = 127 Started new anti-cancer therapy n = 5 (5%) Subsequent SCT in remission (MRD-negative) n = 18 (18%) Ongoing remission without subsequent SCT or other therapy‡ n = 40 (40%) No response or not evaluable n = 28 Relapsed/ died n = 36 (36%) Data cut-off date: February 7, 2024 Median follow-up: 21.5 months (range: 8.6–41.4) Jabbour et al., ASCO 2024

FELIX study all cohorts: Event-free survival (n=127) Developing Next Generation Programmed T Cell Therapies 7 Subset of patients benefit from standalone treatment with obe-cel 44.0 (35.2, 52.5) 127 12231017263647637991 Without censoring for SCT Without censoring for SCT 9.0 (6.57, 14.32) P ro b ab ili ty ( % ) 90 80 70 60 50 40 30 20 10 100 0 Time (months)Patients at risk 12-month EFS rate (95% CI), %: Censoring for SCT (main analysis) 0 363534333231302928272625242322212019181716151413121110987654321 37 127 2315285385 129233865 Censoring for SCT 49.5 (39.6, 58.6) Median (95% CI), months: 11.9 (7.98, 22.11) • All (18/18) patients who had SCT in remission were MRD-negative • 10/18 patients (55.6%) had ongoing CAR T persistence prior to SCT (n = 2 ongoing without event; n = 8 relapse or death) • Characteristics similar between patients who did and did not undergo consolidative SCT Jabbour et al., ASCO 2024

FELIX study all cohorts: Overall survival (n=127) Developing Next Generation Programmed T Cell Therapies 8 Potential long-term plateau P ro b ab ili ty ( % ) 90 80 70 60 50 40 30 20 10 100 0 Time (months)Patients at risk 237255186108127 Without censoring for SCT (main analysis) 0 413937353331292725232119171513119751 3 43 12-month OS rate (95% CI), %: Without censoring for SCT 61.1 (52.0, 69.0) 15.6 (12.91, NE) 63.7 (53.7, 72.0) 235193769100127 Censoring for SCT Censoring for SCT 23.8 (12.91, NE)Median (95% CI), months: Jabbour et al., ASCO 2024

FELIX study all cohorts: CAR T persistence and predicted relapse Developing Next Generation Programmed T Cell Therapies 9 Ongoing CAR T persistence correlates with long-term EFS HR 2.7 (95% CI: 1.4, 5.3) HR 1.7 (95% CI: 0.7, 3.8) P re d ic te d E FS Loss of CAR T persistence at Month 6 Loss of CAR T persistence at Month 12 Ongoing CAR T persistence 0.8 0.6 0.4 0.2 1.0 0.0 Months since obe-cel infusion 0 363330272421181512963 P re d ic te d E FS B-cell recovery at Month 6 B-cell recovery at Month 12 Ongoing B-cell aplasia 0.8 0.6 0.4 0.2 1.0 0.0 Months since obe-cel infusion 0 363330272421181512963 Jabbour et al., ASCO 2024

ASCO 2024 takeaway messages Developing Next Generation Programmed T Cell Therapies 10 FELIX study - pooled analysis of all cohorts • 40% of responders in ongoing remission without subsequent SCT/other therapy, with a median follow-up of 21.5 months • Survival outcomes show potential of long-term plateau • SCT consolidation in remission following obe-cel did not improve EFS or OS • Ongoing CAR T persistence was associated with improved EFS

Commercial Launch Readiness

Commercial Readiness Obe-cel steps to commercialization 12 Roadmap to a commercial launch in r/r adult ALL Obe-cel BLA accepted by FDA Nucleus MHRA inspection & approval Obe-cel EMA MAA Developing Next Generation Programmed T Cell Therapies FDA PDUFA Target FDA Action Date November 16 Obtained MHRA MIA together with accompanying GMP certificate Q1 Q2 Q3 Q4 Medical affairs engagement Value and HEOR evidence generation US Center onboarding US supply chain, logistics and systems testing Obe-cel MHRA authorization application 2024

2024 2025 Now-Oct Nov Dec Jan Feb Mar US treatment center timelines for authorization and first patient readiness Centers have their own internal processes / requirements to fulfil prior to administering CAR T; therefore, not every center will be ready to prescribe upon receiving Autolus authorization Qualification (activities ongoing) Activation Activities Complete = Authorization Activation Trigger PDUFA* (Nov 16th) Autolus Authorization Example Center-defined Activities (varies by center) 1. Conduct final trainings based on FDA approved label 2. Administer Risk Evaluation & Mitigation Strategy training ✓ Center Electronic Health Records order sets for obe-cel ✓ Pharmacy & Therapeutics Committee review ✓ Value assessment ✓ Financial clearance finalized ✓ External center authorization document ✓ Addition to Authorized Treatment Center locator *FDA=US Food and Drug Administration; PDUFA=Prescription Drug User Fee Act Developing Next Generation Programmed T Cell Therapies 13

Key steps from approval to patients dosed Final steps of center activation are driven by the actual label Developing Next Generation Programmed T Cell Therapies 2024 2025 Key steps Anticipated Timing Complete site accreditation (e.g. final label, training plans, REMS and Out of Specification (OOS) protocol) 2 – 12 weeks Patient screening and leukapheresis scheduled/completed 1 – 2 weeks Anticipated vein to delivery time 16 days 14 Based on a potential November approval and considering year-end holidays, expectation would be for a first patient dosed early 2025

Expanding the obe-cel opportunity Deep value program with potentially broad applicability

The obe-cel product family and franchise opportunity Developing Next Generation Programmed T Cell Therapies 16 Obe-cel CD19 AUTO1/22 CD19/CD22 AUTO8 CD19/BCMA B-ALL and B-NHL B-cell mediated autoimmune disease B-ALL and B-NHL Multiple Myeloma B-cell and plasma cell mediated autoimmune • Optimized CD19 CAR design • Potential best-in-class efficacy and safety profile • Supported by state-of-the-art manufacturing • Supported by mature FELIX clinical/CMC package • Dual CD19 & CD22 Targeting • Designed to prevent antigen negative escape • Supported by Phase 1 data in pediatric B-ALL • Dual CD19 & BCMA Targeting • Designed to induce deep and durable responses • Initial Phase 1 data presented at ASH 2023

Dynamic environment in cell therapy for autoimmune patients Developing Next Generation Programmed T Cell Therapies 17 EULAR updates continue to support overall proof of concept/biology in autoimmune disease • Available clinical data is largely based on compassionate use experience with more clinical trial data emerging • A Kymriah-like autologous CAR T program showed transformational clinical outcomes in refractory autoimmune patients – To date a single myositis patient relapsed after 18 months (compassionate use cohort) – Response rate expectations for the field were set high ~100% • Some variability in clinical outcomes is beginning to emerge – All CD19 CAR Ts may not be alike; different design and manufacturing process may contribute – Patient populations vary across data sets – All autoimmune indications may not be alike – inflammatory process versus structural damage • Obe-cel has shown profound removal of the B cell compartment, indicated by the long-term outcomes in ALL without subsequent therapy while showing a favorable safety profile in this challenging patient population. • Obe-cel shows a comparable profile to Erlangen CAR-T program in dose, molecular remission rates, persistence based on pediatric ALL experience while differentiating with lower immunological toxicity (CRS, ICANS) Autoimmune

• Erlangen CD19 CART was developed for treating paediatric ALL – CD19 CAR is identical to Kymriah – Manufacturing modified from Kymriah – Initial data shown in paediatric ALL patients at ASH 2021 in line with data from Kymriah • Obe-cel has a modified design to reduce immunological toxicity compared to Kymriah • Obe-cel experience in pediatric and adult ALL confirm differentiated profile – High level of molecular complete remissions – Lasting responses – Similar persistence of CART cells – Reduced immunological toxicity (CRS, ICANS) 18 Obe-cel is similar to Erlangen CD19 CART Differentiated CD19 engagement (fast off-rate) Off Rate: Kd [S-1] ]1 - S 1 - [M a K : e Ra t - On Other CD19 Binders Obe-cel Binder Off Rate: Kd [S-1] O n -R at e: K a [M -1 S- 1 ] Shorter half-life of interaction compared to binders used in approved products • obe-cel = 9.8 seconds (CAT) • Kymriah® = 21 minutes (FMC63) CARPALL1 FELIX2 FELIX2 low disease burden ELIANA3 Indication Pediatric Adult Adult Pediatric n 14 127 29 75 ORR 86% 78% 100% 83% 12mth EFS 54% 50% 65% 50% CRS any Grade 93% 69% 47% 77% CRS > Grade 3 0% 2% 0% 48% ICANS any Grade 50% 23% 8% 71% ICANS > Grade 3 7% 7% 0% 22% 1. Ghorashian et al., Nature Medicine 2019 2. Roddie et al, ASH 2023 3. USPI 2023, Maude et al., NEJM 2018 Low disease burden defined as <5% bone marrow blast at lymphodepletion obe-cel Kymriah Autoimmune Developing Next Generation Programmed T Cell Therapies

Phase 1 study in r/r SLE – enrollment ongoing Developing Next Generation Programmed T Cell Therapies 19 Primary goal of the Phase 1 study will be confirming the fixed dose in adult SLE patients * A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) – Full Text View – ClinicalTrials.gov Autoimmune CARLYSLE Study • A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus (SLE)* Study details • Number of patients: 6 (option to add further cohort of 6 patients) • Primary endpoint: to establish the tolerability and safety of obe-cel in patients with severe, refractory SLE • Secondary endpoints: to evaluate the preliminary efficacy of obe-cel using measures of SLE disease activity • Dosing: 50 x 106 CD19 CAR-positive T cells • Follow up: up to 12 months • 3 centers enrolling in UK and Spain • Initial clinical data expected in late 2024

Other pipeline programs and technologies A broad portfolio of potential next generation modular T cell therapies

Autolus pipeline Developing Next Generation Programmed T Cell Therapies 21 Product Indication Target Study Name Partner Phase Status/Expected Milestones Obe-cel Adult B-ALL CD19 FELIX Pivotal Submitted to EMA, MHRA and FDA (PDUFA November 16, 2024) Obe-cel Systemic Lupus Erythematosus CD19 CARLYSLE Phase 1 Initial data late 2024 Obe-cel B-NHL and CLL CD19 ALLCAR19 UCL Phase 1 Data in peer reviewed journal Obe-cel PCNSL CD19 CAROUSEL UCL | Phase 1 Data in peer reviewed journal AUTO1/22 Pediatric ALL CD19 & CD22 CARPALL UCL * Phase 1 Data in BLOOD August 2023 AUTO8 Multiple Myeloma CD19 & BCMA MCARTY Phase 1 Update in 2025 * BioNTech holds an option to co-fund and co-commercialize Obe-cel product family Product Indication Target Study Name Partner Phase Status/Expected Milestones AUTO4 TRBC1+ Peripheral TCL TRBC1 LibrA T1 Phase 1 Data in peer reviewed journal AUTO5 TRBC2+ Peripheral TCL TRBC2 – Preclinical Data in peer reviewed journal AUTO6NG Neuroblastoma GD2 MAGNETO UCL | BioNTech * Phase 1 Open and actively recruiting AUTO9 Acute Myeloid Leukemia CD33, CD123 & CLL1 TBD UCL Preclinical Estimated Phase 1 start 2025 Additional pipeline programs Oncology Autoimmune

Financial Results

Financial summary (unaudited) USD ($’ 000) Q2 2024 Q4 2023 Variance Cash and cash equivalents 705,939 239,566 466,373 Q2 2024 Q2 2023 Variance Operating expenses: R&D (36,612) (33,232) (3,380) G&A (21,903) (11,122) (10,781) Loss on disposal of property and equipment - (23) 23 Impairment of operating lease right-of-use assets and related property and equipment (414) - (414) Total operating expense, net (58,929) (44,377) (14,552) Other income, net 1,226 482 744 Interest Income 9,656 3,403 6,253 Interest expense (10,174) (5,020) (5,154) Income tax expense (51) (40) (11) Net loss (58,272) (45,552) (12,720) Building a fully integrated, next-generation CAR T company 23

Upcoming news flow

Autolus planned news flow Developing Next Generation Programmed T Cell Therapies 25 Anticipated Milestone or Data Catalysts Anticipated Timing Obe-cel U.S. FDA PDUFA target action date November 16, 2024 Obe-cel FELIX data update at ASH 2024 December 2024 Obe-cel in autoimmune disease – initial data from SLE Phase 1 study Late 2024

Autolus.com Thank you

Cover	Aug. 08, 2024
Entity Listings [Line Items]
Document Type	8-K
Document Period End Date	Aug. 08, 2024
Entity Registrant Name	Autolus Therapeutics plc
Entity Incorporation, State or Country Code	X0
Entity File Number	001-38547
Entity Address, Address Line One	The Mediaworks
Entity Address, Address Line Two	191 Wood Lane
Entity Address, City or Town	London
Entity Address, Postal Zip Code	W12 7FP
Entity Address, Country	GB
City Area Code	(44) 20
Local Phone Number	3829 6230
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Central Index Key	0001730463
Amendment Flag	false
Entity Emerging Growth Company	false
Common Class A
Entity Listings [Line Items]
Title of 12(b) Security	Ordinary shares, nominal value $0.000042 per share*
Trading Symbol	*
Security Exchange Name	NASDAQ
8880 American Depositary Receipts
Entity Listings [Line Items]
Title of 12(b) Security	American Depositary Shares, each representing one ordinary share, nominal value $0.000042 per share
Trading Symbol	AUTL
Security Exchange Name	NASDAQ