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Autolus Therapeutics plc
Response Received
1 company response(s)
High - file number match
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-11-07
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-06-18
Autolus Therapeutics plc
Summary
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Company responded
2020-06-30
Autolus Therapeutics plc
References: June 18, 2020
Summary
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Company responded
2024-09-30
Autolus Therapeutics plc
References: September 19, 2024
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-09-19
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-05-09
Autolus Therapeutics plc
Summary
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Company responded
2022-05-13
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-20
Autolus Therapeutics plc
Summary
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Company responded
2022-04-26
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-08-12
Autolus Therapeutics plc
Summary
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Company responded
2021-08-16
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-07-09
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-07-22
Autolus Therapeutics plc
Summary
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Company responded
2019-07-22
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2019-04-08
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2019-04-08
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-11-29
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Response Received
6 company response(s)
High - file number match
Company responded
2018-05-10
Autolus Therapeutics plc
References: May 7, 2018
Summary
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↓
SEC wrote to company
2018-05-17
Autolus Therapeutics plc
Summary
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Company responded
2018-05-30
Autolus Therapeutics plc
References: March 8, 2018
Summary
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Company responded
2018-06-08
Autolus Therapeutics plc
References: May 17, 2018
Summary
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Company responded
2018-06-19
Autolus Therapeutics plc
Summary
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Company responded
2018-06-19
Autolus Therapeutics plc
References: June 15, 2018
Summary
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Company responded
2018-06-19
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-06-15
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-05-08
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-04-09
Autolus Therapeutics plc
Summary
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Autolus Therapeutics plc
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-03-09
Autolus Therapeutics plc
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-13 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2025-05-12 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 333-287097 | Read Filing View |
| 2024-11-07 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 001-38547 | Read Filing View |
| 2024-09-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2024-09-19 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 001-38547 | Read Filing View |
| 2022-05-13 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-05-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-04-26 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-04-20 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2021-08-16 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2021-08-12 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-07-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-06-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-06-18 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-07-22 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-07-22 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-04-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-04-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-11-29 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-15 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-17 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-10 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-08 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-04-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-03-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-12 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 333-287097 | Read Filing View |
| 2024-11-07 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 001-38547 | Read Filing View |
| 2024-09-19 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | 001-38547 | Read Filing View |
| 2022-05-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-04-20 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2021-08-12 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-07-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-06-18 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-07-22 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-11-29 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-15 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-17 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-08 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-04-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-03-09 | SEC Comment Letter | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-13 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2024-09-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-05-13 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2022-04-26 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2021-08-16 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2020-06-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-07-22 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-04-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2019-04-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-19 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-06-08 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-30 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
| 2018-05-10 | Company Response | Autolus Therapeutics plc | United Kingdom | N/A | Read Filing View |
2025-05-13 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP The MediaWorks 191 Wood Lane White City London W12 7FP United Kingdom VIA EDGAR May 13, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Autolus Therapeutics plc Registration Statement on Form S-1 File No. 333-287097 Acceleration Request Requested Date: May 15, 2025 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “ Registration Statement ”) to become effective on May 15, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Christian Plaza, Courtney Thorne and William DuVal of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with William DuVal of Cooley LLP at (703) 456-8663, or in his absence, Courtney Thorne at (617) 937-2318. Thank you for your assistance with this matter. Sincerely, AUTOLUS THERAPEUTICS PLC By: /s/ Christian Itin Christian Itin Chief Executive Officer cc: Alex Driggs, Autolus Therapeutics plc Christian Plaza, Cooley LLP Courtney Thorne, Cooley LLP William DuVal, Cooley LLP
2025-05-12 - UPLOAD - Autolus Therapeutics plc File: 333-287097
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 12, 2025 Christian Itin, Ph.D. Chief Executive Officer Autolus Therapeutics plc The MediaWorks 191 Wood Lane White City London W12 7FP United Kingdom Re: Autolus Therapeutics plc Registration Statement on Form S-1 Filed May 8, 2025 File No. 333-287097 Dear Christian Itin Ph.D.: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: William DuVal </TEXT> </DOCUMENT>
2024-11-07 - UPLOAD - Autolus Therapeutics plc File: 001-38547
November 7, 2024
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics plc
191 Wood Lane
London W12 7FP
United Kingdom
Re:Autolus Therapeutics plc
Form 10-K for Fiscal Year Ended December 31, 2023
File No. 001-38547
Dear Christian Itin Ph.D.:
We have completed our review of your filing. We remind you that the company and
its management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-09-30 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm Document September 30, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Sebastian Gomez Abero Re: Autolus Therapeutics plc Form 10-K for Fiscal Year Ended December 31, 2023 Filed March 21, 2024 File No. 001-38547 Dear Mr. Howes and Mr. Gomez Abero: Autolus Therapeutics plc (the “Company”) sets forth below its response to the comment received in the letter dated September 19, 2024 (the “Comment Letter”) from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) related to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed on March 21, 2024 (the “2023 Form 10-K”). To facilitate the Staff’s review, the Staff’s comment as communicated in the Comment Letter is reprinted below in italics and is followed by the Company’s response. Form 10-K for Fiscal Year Ended December 31, 2023 Item 11. Executive Compensation, page 128 1. We note you have checked the box stating that your filing contains error corrections to previously issued financial statements that required a recovery analysis of incentive-based compensation received by your executive officers. However, we do not note any disclosure related to your recovery analysis. Please provide the information required by Item 402(w) of Regulation S-K. Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company concluded that no recovery of compensation was required pursuant to the Company’s compensation recovery policy. However, the disclosure responsive to Item 402(w)(2) regarding the recovery analysis was inadvertently omitted from the 2023 Form 10-K. Autolus Therapeutics plc, The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom T: 020 3829 6230 www.autolus.com Registered in England no: 11185179 As described on page 134 of the 2023 Form 10-K under the heading “Clawbacks,” the Company adopted a Dodd-Frank Act-compliant clawback policy, referred to as the Incentive Compensation Recoupment Policy, which was filed as Exhibit 97.1 to the 2023 Form 10-K. The Incentive Compensation Recoupment Policy applies to Incentive Compensation (as defined in the Incentive Compensation Recoupment Policy) received on or after October 2, 2023. The Company advises the Staff that the only Incentive Compensation paid on or after October 2, 2023 that was earned based on the attainment of a Financial Reporting Measure (as defined in the Incentive Compensation Recoupment Policy) was the annual cash bonus paid in March 2024 for individual and company performance during the year ended December 31, 2023. The Company has from time to time also granted performance-based restricted stock units and performance-based stock options to its officers; however, the performance conditions for vesting of all such awards granted to date have related to the achievement of clinical development or regulatory milestones and not on the achievement of any Financial Reporting Measure. With respect to the annual cash bonuses paid to the Company’s senior management in 2024 for performance during 2023, the performance goals related primarily to research, clinical development and regulatory milestones; however, two of the performance goals contained a financial component: (i) entering into a collaboration for the Company’s product candidate obe-cel with a positive net cash flow impact on the Company of at least a specified amount, and (ii) generating collaboration and technology licensing income of at least a specified amount. When the Compensation Committee of the Company’s Board of Directors evaluated the achievement of the corporate goals for 2023, the Committee also took into account that the Company had completed a public offering of its equity securities in February 2023, which was not contemplated when the corporate goals for 2023 were originally established. As described in Note 3 to the Company’s financial statements included in the 2023 Form 10-K, in connection with the preparation of the Company's consolidated financial statements as of and for the year ended December 31, 2023, the Company discovered that in prior years it had incorrectly accounted and presented its U.K Small and Medium-Sized Enterprise (SME) tax credit in accordance with ASC 740 - Income Taxes. The error resulted in an overstatement of both income tax benefit and research and development expense, and therefore total operating expenses, of $24.6 million and $24.0 million for the years ended December 31, 2022 and 2021, respectively. The correction of the foregoing error only impacted the Company’s consolidated statement of operations and comprehensive loss and had no impact on the Company’s consolidated balance sheet, consolidated statement of cash flows or consolidated statement of stockholders’ equity. Within the consolidated statement of operations and comprehensive loss, the Company’s income tax benefit was reduced by $24.6 million and $24.0 million for the years ended December 31, 2022 and 2021, respectively, with corresponding reductions in research and development expenses and total operating expenses. There was no impact on net loss attributable to the Company’s ordinary shareholders in any of the periods. Autolus Therapeutics plc, The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom T: 020 3829 6230 www.autolus.com Registered in England no: 11185179 As none of the Financial Measures that were part of the annual cash bonuses paid in March 2024 related to income tax expense/benefit, research and development expense or total operating expense, the Company concluded that no recovery of erroneously awarded compensation was required under the Incentive Compensation Recoupment Policy. Please direct any questions concerning this letter to Brian F. Leaf of Cooley LLP at +1 703 456 8053 or bleaf@cooley.com or Courtney T. Thorne of Cooley LLP at +1 617 937 2318 or cthorne@cooley.com. Sincerely, /s/Christian Itin Christian Itin, Ph.D. Chief Executive Officer Autolus Therapeutics plc Cc: Alex Driggs, Autolus Therapeutics plc Robert Dolski, Autolus Therapeutics plc Courtney T. Thorne, Cooley LLP Brian F. Leaf, Cooley LLP Christian E. Plaza, Cooley LLP
2024-09-19 - UPLOAD - Autolus Therapeutics plc File: 001-38547
September 19, 2024
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics plc
191 Wood Lane
London W12 7FP
United Kingdom
Re:Autolus Therapeutics plc
Form 10-K for Fiscal Year Ended December 31, 2023
File No. 001-38547
Dear Christian Itin Ph.D.:
We have reviewed your filing and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2023
Item 11. Executive Compensation, page 128
1.We note you have checked the box stating that your filing contains error corrections to
previously issued financial statements that required a recovery analysis of incentive-based
compensation received by your executive officers. However, we do not note any
disclosure related to your recovery analysis. Please provide the information required by
Item 402(w) of Regulation S-K.
We remind you that the company and its management are responsible for the accuracy and
adequacy of their disclosures, notwithstanding any review, comments, action or absence of action
by the staff.
Please contact Tyler Howes at 202-551-3370 or Sebastian Gomez Abero at 202-551-3578
with any other questions.
September 19, 2024
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-05-13 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP The MediaWorks 191 Wood Lane White City London W12 7FP United Kingdom VIA EDGAR May 13, 2022 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Autolus Therapeutics plc Registration Statement on Form F-3 File No. 333-264650 Acceleration Request Requested Date: May 17, 2022 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-3 (the “Registration Statement”) to become effective on May 17, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Darren DeStefano, Courtney Thorne and William DuVal of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP at (703) 456-8034, or in his absence, Courtney Thorne at (617) 937-2318. Thank you for your assistance with this matter. Sincerely, AUTOLUS THERAPEUTICS PLC By: /s/ Christian Itin Christian Itin Chief Executive Officer cc: Alex Driggs, Autolus Therapeutics plc Darren DeStefano, Cooley LLP Christian Plaza, Cooley LLP Courtney Thorne, Cooley LLP
2022-05-09 - UPLOAD - Autolus Therapeutics plc
United States securities and exchange commission logo
May 9, 2022
Christian Itin, Ph.D.
Chief Executive Officer and Director
Autolus Therapeutics plc
The MediaWorks
191 Wood Lane
White City
London W12 7FP
United Kingdom
Re:Autolus Therapeutics plc
Registration Statement on Form F-3
Filed May 4, 2022
File No. 333-264650
Dear Christian Itin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney Thorne
2022-04-26 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP The MediaWorks 191 Wood Lane White City London W12 7FP United Kingdom VIA EDGAR April 26, 2022 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Autolus Therapeutics plc Registration Statement on Form F-3 File No. 333-264304 Acceleration Request Requested Date: April 28, 2022 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-3 (the “Registration Statement”) to become effective on April 28, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Darren DeStefano, Courtney Thorne and William DuVal of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP at (703) 456-8034, or in his absence, Courtney Thorne at (617) 937-2318. Thank you for your assistance with this matter. Sincerely, AUTOLUS THERAPEUTICS PLC By: /s/ Christian Itin Christian Itin Chief Executive Officer cc: Matthias Alder, Autolus Therapeutics plc Alex Driggs, Autolus Therapeutics plc Darren DeStefano, Cooley LLP Christian Plaza, Cooley LLP Courtney Thorne, Cooley LLP
2022-04-20 - UPLOAD - Autolus Therapeutics plc
United States securities and exchange commission logo
April 20, 2022
Christian Itin
Chief Executive Officer and Director
Autolus Therapeutics plc
The MediaWorks
191 Wood Lane
White City
London W12 7FP
United Kingdom
Re:Autolus Therapeutics plc
Registration Statement on Form F-3
Filed April 15, 2022
File No. 333-264304
Dear Dr. Itin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Laura Crotty at 202-551-7614 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian F. Leaf
2021-08-16 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP Forest House 58 Wood Lane White City London W12 7RZ United Kingdom VIA EDGAR August 16, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Autolus Therapeutics plc Registration Statement on Form F-3 File No. 333-258556 Acceleration Request Requested Date: August 18, 2021 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-3 (the “Registration Statement”) to become effective on August 18, 2021, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Darren DeStefano, Courtney Thorne and William DuVal of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP at (703) 456-8034, or in his absence, Courtney Thorne at (617) 937-2318. Thank you for your assistance with this matter. Sincerely, AUTOLUS THERAPEUTICS PLC By: /s/ Christian Itin Christian Itin Chief Executive Officer cc: Matthias Alder, Autolus Therapeutics plc Alex Driggs, Autolus Therapeutics plc Darren DeStefano, Cooley LLP Christian Plaza, Cooley LLP Courtney Thorne, Cooley LLP
2021-08-12 - UPLOAD - Autolus Therapeutics plc
United States securities and exchange commission logo
August 12, 2021
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics plc
Forest House
58 Wood Lane
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics plc
Registration Statement on Form F-3
Filed August 5, 2021
File No. 333-258556
Dear Dr. Itin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney T. Thorne, Esq.
2020-07-09 - UPLOAD - Autolus Therapeutics plc
United States securities and exchange commission logo
July 9, 2020
Christian Itin
Chief Executive Officer
Autolus Therapeutics plc
Forest House
58 Wood Lane
London W12 7RZ United Kingdom
Re:Autolus Therapeutics plc
Form 20-F for the Fiscal Year Ended December 31, 2019
Filed March 3, 2020
File No. 001-38547
Dear Mr. Itin:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-06-30 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP Darren K. DeStefano + 1 703 456 8034 ddestefano@cooley.com VIA EDGAR June 30, 2020 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Gary Newberry Mr. Kevin Kuhar Re: Autolus Therapeutics plc Form 20-F for the Fiscal Year Ended December 31, 2019 Filed March 3, 2020 File No. 001-38547 Ladies and Gentlemen: On behalf of our client, Autolus Therapeutics plc (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated June 18, 2020 (the “Comment Letter”), relating to the above referenced Form 20-F for the fiscal year ended December 31, 2019. The Staff’s comment is repeated below and is followed by the Company’s response thereto. Exhibits 1. We note the certifications provided in Exhibits 12.1 and 12.2 do not include paragraph 4(b) and the introductory language in paragraph 4 referring to internal control over financial reporting after the end of the transition period that allows for these omissions. Please file an abbreviated amendment containing the cover page, explanatory note, signature page and currently dated certifications that include paragraphs 1, 2, 4 and 5. Refer to Item 19(12) of Form 20-F and Regulation S-K Compliance & Disclosure Interpretation 246.13. Response to Comment 1: In response to the Staff’s comment, the Company has filed Amendment No. 1 to Form 20-F for the fiscal year ended December 31, 2019 on June 30, 2020, which contains the updated certifications as Exhibit 12.1 and Exhibit 12.2. * * * * June 30, 2020 Page 2 Please direct any questions or comments concerning this response letter to the undersigned at (703) 456-8034, Brian Leaf at (703) 456-8053 or Courtney Thorne at (617) 937-2318. Very truly yours, /s/ Darren K. DeStefano Darren K. DeStefano cc: Andrew Oakley, Autolus Therapeutics plc Alex Driggs, Autolus Therapeutics plc Brian F. Leaf, Cooley LLP Courtney T. Thorne, Cooley LLP
2020-06-18 - UPLOAD - Autolus Therapeutics plc
United States securities and exchange commission logo
June 18, 2020
Christian Itin
Chief Executive Officer
Autolus Therapeutics plc
Forest House
58 Wood Lane
London W12 7RZ United Kingdom
Re:Autolus Therapeutics plc
Form 20-F for the Fiscal Year Ended December 31, 2019
Filed March 3, 2020
File No. 001-38547
Dear Mr. Itin:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 20-F for the Fiscal Year Ended December 31, 2019
Exhibits
1.We note the certifications provided in Exhibits 12.1 and 12.2 do not include paragraph
4(b) and the introductory language in paragraph 4 referring to internal control over
financial reporting after the end of the transition period that allows for these omissions.
Please file an abbreviated amendment containing the cover page, explanatory note,
signature page and currently dated certifications that include paragraphs 1, 2, 4 and 5.
Refer to Item 19(12) of Form 20-F and Regulation S-K Compliance & Disclosure
Interpretation 246.13.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
FirstName LastNameChristian Itin
Comapany NameAutolus Therapeutics plc
June 18, 2020 Page 2
FirstName LastName
Christian Itin
Autolus Therapeutics plc
June 18, 2020
Page 2
You may contact Gary Newberry at (202) 551-3761 or Kevin Kuhar, Accounting Branch
Chief, at (202) 551-3662 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-07-22 - UPLOAD - Autolus Therapeutics plc
July 22, 2019
Christian Itin
Chief Executive Officer
Autolus Therapeutics plc
Forest House
58 Wood Lane
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics plc
Registration Statement on Form F-3
Filed July 17, 2019
File No. 333-232690
Dear Mr. Itin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Courtney T. Thorne, Esq.
2019-07-22 - CORRESP - Autolus Therapeutics plc
CORRESP
1
filename1.htm
CORRESP
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
VIA EDGAR
July 22, 2019
U.S.
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Autolus Therapeutics plc
Registration Statement on Form F-3
File No. 333-232690
Acceleration Request
Requested Date:
July 24, 2019
Requested Time:
4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the
“Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-3 (the
“Registration Statement”) to become effective on July 24, 2019, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the
staff. The Registrant hereby authorizes each of Darren DeStefano, Courtney Thorne and William DuVal of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP at (703) 456-8034, or in his absence, Courtney Thorne at (617) 937-2318. Thank you for your assistance with this matter.
Sincerely,
AUTOLUS THERAPEUTICS PLC
By:
/s/ Christian Itin
Christian Itin
Chief Executive Officer
cc:
Matthias Alder, Autolus Therapeutics plc
Alex Driggs, Autolus Therapeutics plc
Darren DeStefano, Cooley LLP
Christian Plaza, Cooley LLP
Courtney Thorne, Cooley LLP
2019-04-08 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP April 8, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christine Westbrook Re: Autolus Therapeutics plc Registration Statement on Form F-1 (CIK No. 0001730463) (the “Registration Statement”) Ms. Westbrook: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Autolus Therapeutics plc that the effectiveness of the Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on April 10, 2019, or as soon thereafter as practicable. Pursuant to Rule 460 under the Act, please be advised that we expect to take all reasonable steps to effect the distribution of as many copies of the preliminary prospectus, dated as of the date hereof (“Preliminary Prospectus”), to secure adequate distribution of the Preliminary Prospectus to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. In connection with the Preliminary Prospectus distribution for the above-referenced issue, we hereby confirm that we are, and the other prospective underwriters have confirmed that they are, complying with the 48-hour requirement as promulgated by Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of page intentionally left blank] Very truly yours, GOLDMAN SACHS & CO. LLC JEFFERIES LLC As Representatives of the several Underwriters GOLDMAN SACHS & CO. LLC By: /s/ Elizabeth Wood Name: Elizabeth Wood Title: Managing Director JEFFERIES LLC By: /s/ Matthew Kim Name: Matthew Kim Title: Managing Director [Signature Page to Request for Acceleration of Effectiveness]
2019-04-08 - CORRESP - Autolus Therapeutics plc
CORRESP
1
filename1.htm
CORRESP
Autolus Therapeutics plc
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
VIA EDGAR
April 8, 2019
U.S. Securities
and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Mary Beth Breslin
Ms. Christine Westbrook
Re:
Autolus Therapeutics plc
Registration Statement on Form F-1
File No. 333-230767
Acceleration Request
Requested Date: Wednesday, April 10, 2019
Requested Time: 4:30 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-1 to
become effective on April 10, 2019, at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Darren
DeStefano, Brian Leaf, Courtney Thorne and Katie Kazem of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
Once
the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP at + 1 703 456 8034, or in his absence, Courtney Thorne at + 1 617 937 2318. Thank you for your
assistance with this matter.
[Signature Page Follows]
Sincerely,
AUTOLUS THERAPEUTICS PLC
By:
/s/ Christian Itin
Christian Itin
Chief Executive Officer
cc:
Matthias Alder, Autolus Therapeutics plc
Darren DeStefano, Cooley LLP
Christian Plaza, Cooley LLP
Brian Leaf, Cooley
LLP
Courtney Thorne, Cooley LLP
Katie
Kazem, Cooley LLP
2018-11-29 - UPLOAD - Autolus Therapeutics plc
November 29, 2018
Christian Itin
Chief Executive Officer
Autolus Therapeutics plc
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics plc
Draft Registration Statement on Form F-1
Submitted November 23, 2018
CIK No. 0001730463
Dear Mr. Itin:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano, Esq.
2018-06-19 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP June 19, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Mary Beth Breslin Ms. Irene Paik Mr. Mark Brunhofer Ms. Mary Mast Re: Autolus Therapeutics plc Registration Statement on Form F-1 (File No. 333-224720) (the “Registration Statement”) Ladies and Gentleman: In connection with the above-referenced Registration Statement and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Autolus Therapeutics plc that the effectiveness of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on June 21, 2018, or as soon thereafter as practicable. Pursuant to Rule 460 of the General Rules and Regulations under the Act, please be advised that we and the other prospective underwriters have distributed approximately 1,292 copies of the preliminary prospectus dated June 8, 2018 (the “Preliminary Prospectus”) between June 8, 2018 and the date hereof to prospective underwriters, dealers, institutional investors and others. In connection with the Preliminary Prospectus distribution for the above-referenced issue, we hereby confirm that we are, and the other prospective underwriters have confirmed that they are, complying with the 48-hour requirement as promulgated by Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of page intentionally left blank] Very truly yours, GOLDMAN SACHS & CO. LLC JEFFERIES LLC As Representatives of the several Underwriters GOLDMAN SACHS & CO. LLC. By: /s/ Elizabeth Wood Name: Elizabeth Wood Title: Managing Director JEFFERIES LLC By: /s/ Matthew Kim Name: Matthew Kim Title: Managing Director [Signature Page to Request for Acceleration of Effectiveness]
2018-06-19 - CORRESP - Autolus Therapeutics plc
CORRESP
1
filename1.htm
CORRESP
Darren K. DeStefano
+ 1 703 456 8034
ddestefano@cooley.com
VIA EDGAR
June 19, 2018
U.S. Securities and Exchange Commission
Division of Corporation
Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Mary Beth Breslin
Ms. Irene Paik
Mr. Mark Brunhofer
Ms. Mary Mast
Re:
Autolus Therapeutics Ltd.
Amendment
No. 2 to Registration Statement on Form F-1
Filed June 8,
2018
File No. 333-224720
Ladies and Gentlemen:
On behalf of our client, Autolus
Therapeutics plc (formerly known as Autolus Therapeutics Limited) (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) contained in its letter dated June 15, 2018 (the “Comment Letter”), relating to the above referenced Registration Statement on Form F-1 filed
with the Commission on May 7, 2018 (File No. 333-224720) as amended on May 10, 2018 and June 8, 2018 (as amended, the “Registration Statement”). In response to the
comments set forth in the Comment Letter (the “Comments”), the Company has revised the Registration Statement and is filing via EDGAR Amendment No. 3 to the Registration Statement on Form
F-1 (the “Amended Registration Statement”) with this response letter. For the Staff’s reference, we are also delivering a clean copy of the Amended Registration Statement and a
copy marked to show all changes from Amendment No. 2 to the Registration Statement filed on June 8, 2018.
Set forth below are the
Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response
letter correspond to the page numbers of the Amended Registration Statement.
June 19, 2018
Page
2
Amendment No. 2 to Form F-1 filed June 8, 2018
Summary Financial Data, page 17
1.
Please clarify what the current pro forma information under the Statement of Operations and Comprehensive Loss Data represents. In addition, given that under the corporate reorganization all issued equity shares of
Autolus Limited convert on a 3.185-to-1 basis into shares of Autolus Therapeutics Limited stock, please revise your statement of operations and comprehensive loss data
to provide additional pro forma share and per share information for both years presented that reflect the conversion ratio. This comment also applies to your Selected Financial Data on page 93.
Response to Comment 1
In response to the Staff’s comments, the Company has revised the presentation of its financial data and accompanying footnotes thereto on
pages 18, 19 and 94 of the Amended Registration Statement.
Part II. Information Not Required in Prospectus
Item 7. Recent Sales of Unregistered Securities, page II-1
2.
Please tell us why your share option grants from July 3, 2014 through the date of the prospectus as disclosed on page II-2 declined from 4,365,562 in your previous amendment
to 1,454,934 in this amendment.
Response to Comment 2
In response to the Staff’s comments, the Company has revised the disclosure on page II-2 of the Amended Registration Statement. The
Company’s prior disclosure of its share option grants in its most recent amendment dated June 8, 2018 took into account the conversion ratio for the Company’s corporate reorganization.
3.
Please revise your disclosure throughout this item to clearly indicate that the share and per share information presented does not reflect the conversion ratio inherent in your corporate reorganization.
Response to Comment 3
In response to the Staff’s comments, the Company has revised the disclosure on page II-1 of the Amended Registration Statement.
Exhibits
4.
It is inappropriate to include assumptions in a legal opinion that are too broad, assume material facts underlying the opinion or any readily ascertainable facts. Please have counsel remove the assumptions in paragraph
(f) and (l) of Schedule 1 in Exhibit 5.1, or tell us why they are necessary and appropriate.
June 19, 2018
Page
3
Response to
Comment 4
The Company is filing a revised legal opinion of Cooley (UK) LLP as Exhibit 5.1 to the Amended Registration Statement to
address the Staff’s comment.
5.
Please file an opinion that does not include the qualification in paragraph (d) of Schedule 2 and that otherwise makes clear that counsel has reviewed all matters and made such inquiries as are necessary to render
its opinion.
Response to Comment 5
The Company is filing a revised legal opinion of Cooley (UK) LLP as Exhibit 5.1 to the Amended Registration Statement to address the
Staff’s comment.
June 19, 2018
Page
4
* * * *
Please direct any questions or comments concerning the Amended Registration Statement or this response letter to either the undersigned at +1 703 456 8034,
Brian Leaf at +1 703 456 8053 or Courtney Thorne at + 1 617 937 2318.
Very truly yours,
/s/ Darren K. DeStefano
Darren K. DeStefano
cc:
Christian Itin, Autolus Therapeutics plc
Brian F. Leaf, Cooley LLP
Courtney T. Thorne, Cooley LLP
Patrick O’Brien, Ropes & Gray LLP
2018-06-19 - CORRESP - Autolus Therapeutics plc
CORRESP
1
filename1.htm
CORRESP
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
VIA EDGAR
June 19, 2018
U.S.
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Mary Beth Breslin
Ms. Irene Paik
Mr. Mark Brunhofer
Ms. Mary Mast
Re:
Autolus Therapeutics plc
Registration Statement on Form F-1
File No. 333-224720
Acceleration Request
Requested Date: Thursday, June 21, 2018
Requested Time: 4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”)
hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-1 to
become effective on June 21, 2018, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Darren K.
DeStefano and Courtney Thorne of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
Once the Registration
Statement has been declared effective, please orally confirm that event with Darren K. DeStefano of Cooley LLP at + 1 703 456 8034, or in his absence, Courtney Thorne at + 1 617 937 2318. Thank you for your assistance with this
matter.
[Signature Page Follows]
Sincerely,
AUTOLUS THERAPEUTICS PLC
By:
/s/ Christian Itin
Christian Itin
Chief Executive Officer
cc:
Matthias Alder, Autolus Therapeutics plc
Darren DeStefano, Cooley LLP
Christian Plaza, Cooley LLP
Brian
Leaf, Cooley LLP
Courtney Thorne, Cooley LLP
Katie Kazem, Cooley LLP
2018-06-15 - UPLOAD - Autolus Therapeutics plc
June 15, 2018
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics Ltd
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics Ltd
Amendment No. 2 to Registration Statement on Form F-1
Filed June 8, 2018
File No. 333-224720
Dear Dr. Itin:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 2 to Form F-1 filed June 8, 2018
Summary Financial Data, page 17
1. Please clarify what the current pro forma information under the Statement of Operations
and Comprehensive Loss Data represents. In addition, given that under the corporate
reorganization all issued equity shares of Autolus Limited convert on a 3.185-to-1 basis
into shares of Autolus Therapeutics Limited stock, please revise your statement of
operations and comprehensive loss data to provide additional pro forma share and per
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
June 15, 2018 Page 2
FirstName LastName
Christian Itin, Ph.D.
Autolus Therapeutics Ltd
June 15, 2018
Page 2
share information for both years presented that reflect the conversion ratio. This comment
also applies to your Selected Financial Data on page 93.
Part II. Information Not Required in Prospectus
Item 7. Recent Sales of Unregistered Securities, page II-1
2.Please tell us why your share option grants from July 3, 2014 through the date of the
prospectus as disclosed on page II-2 declined from 4,365,562 in your previous amendment
to 1,454,934 in this amendment.
3.Please revise your disclosure throughout this item to clearly indicate that the share and per
share information presented does not reflect the conversion ratio inherent in your
corporate reorganization.
Exhibits
4.It is inappropriate to include assumptions in a legal opinion that are too broad, assume
material facts underlying the opinion or any readily ascertainable facts. Please have
counsel remove the assumptions in paragraph (f) and (l) of Schedule 1 in Exhibit 5.1, or
tell us why they are necessary and appropriate.
5.Please file an opinion that does not include the qualification in paragraph (d) of Schedule
2 and that otherwise makes clear that counsel has reviewed all matters and made such
inquiries as are necessary to render its opinion.
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano - Cooley LLP
2018-06-08 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP Darren K. DeStefano + 1 703 456 8034 ddestefano@cooley.com VIA EDGAR June 8, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Mary Beth Breslin Ms. Irene Paik Mr. Mark Brunhofer Ms. Mary Mast Re: Autolus Therapeutics Ltd. Registration Statement on Form F-1 Filed May 7, 2018 Amendment No. 1 to Registration Statement on Form F-1 File May 10, 2018 File No. 333-224720 Ladies and Gentlemen: On behalf of our client, Autolus Therapeutics Limited (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated May 17, 2018 (the “Comment Letter”), relating to the above referenced Registration Statement on Form F-1 filed with the Commission on May 7, 2018 (File No. 333-224720) as amended on May 10, 2018, (the “Registration Statement”) and to the comments discussed during a May 25, 2018 telephone conversation between Courtney Thorne, of this office, and the Staff (the “Conversation”) in regards to the Registration Statement. In response to the comments set forth in the Comment Letter (the “Comments”) and as discussed during the Conversation, the Company has revised the Registration Statement and is filing via EDGAR Amendment No. 2 to the Registration Statement on Form F-1 (the “Amended Registration Statement”) with this response letter. For the Staff’s reference, we are also delivering a clean copy of the Amended Registration Statement and a copy marked to show all changes from Amendment No. 1 to the Registration Statement filed on May 10, 2018. Set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Amended Registration Statement. June 8, 2018 Page 2 Registration Statement on Form F-1 filed May 7, 2018 Risk Factors Adverse side effects or other safety risks associated with our product candidates..., page 28 1. We note your disclosure on page 127 that there has been one serious adverse event of Grade 4 neutropenia deemed by the trial investigator to be related to AUTO2. Please also disclose this information in this risk factor. Response to Comment 1 In response to the Staff’s comments, the Company has revised the disclosure on page 29 of the Amended Registration Statement. Amendment No. 1 to Registration Statement on Form F-1 filed May 10, 2018 Exhibits 2. Please provide your auditors’ consent in each amendment that you file. See Item 601(b)(23) of Regulation S-K as stipulated in Item 8a of Form F-1 and Compliance and Disclosure Interpretation 233.03 of the Securities Act Rules. Response to Comment 2 The Company respectfully acknowledges the Staff’s comments and advises the Staff that it will provide its auditors’ consent in future amendments to the Registration Statement. As discussed during the Conversation, the Company has revised the disclosure on page 29 and pages 121-122 of the Amended Registration Statement to disclose the updated clinical data related to the CARPALL trial of AUTO1. June 8, 2018 Page 3 * * * * Please direct any questions or comments concerning the Amended Registration Statement or this response letter to either the undersigned at +1 703 456 8034, Brian Leaf at +1 703 456 8053 or Courtney Thorne at + 1 617 937 2318. Very truly yours, /s/ Darren K. DeStefano Darren K. DeStefano cc: Christian Itin, Autolus Therapeutics Limited Brian F. Leaf, Cooley LLP Courtney T. Thorne, Cooley LLP Patrick O’Brien, Ropes & Gray LLP Emily Oldshue, Ropes & Gray LLP
2018-05-30 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP Darren K. DeStefano +1 703 456 8034 ddestefano@cooley.com May 30, 2018 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Autolus Therapeutics Limited in connection with Registration Statement on Form F-1 (File No. 333-224720) U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Mary Beth Breslin Ms. Irene Paik Mr. Mark Brunhofer Ms. Mary Mast RE: Autolus Therapeutics Limited Registration Statement on Form F-1 Registration No. 333-224720 Ladies and Gentlemen: On behalf of Autolus Therapeutics Limited (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated March 8, 2018 (the “Comment Letter”) relating to the Company’s Registration Statement on Form F-1, originally confidentially submitted with the Commission on February 9, 2018, resubmitted to the Commission on March 22, 2018 and April 27, 2018, and subsequently filed by the Company with the Commission on May 7, 2018 (File No. 333-224720) and amended on May 10, 2018 (the “Registration Statement”), we submit this supplemental letter to further address comment 4 of the Comment Letter. Confidential Treatment Request Due to the commercially sensitive nature of information contained in this letter, the Company hereby requests, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person. The Company has filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations, as well as a copy of this correspondence, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. §200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days’ advance notice of any intended release so that the Company may, if it deems it to be necessary or appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned at (703) 456-8034 rather than rely on the U.S. mail for such notice. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 Cooley LLP One Freedom Square Reston Town Center 11951 Freedom Drive Reston, VA 20190-5656 t: (703) 456-8000 f: (703) 456-8100 cooley.com May 30, 2018 Page Two Staff Comment and Company Response For the convenience of the Staff, we have recited the prior comment from the Staff in italicized type and have followed the comment with the Company’s response. 4. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences between recent valuations of your ordinary shares leading up to the IPO and the estimated offering price. The Company respectfully submits the below additional information to assist the Staff in its review of the Company’s position with respect to its determination of the fair value of its ordinary shares underlying its outstanding equity awards and the reasons for the differences between the recent valuations of its ordinary shares and the estimated valuation range for its initial public offering (“IPO”). Preliminary IPO Valuation Range The Company advises the Staff that, after taking into account the input of the lead underwriters for the proposed IPO, it preliminarily estimates a pre-money valuation range for its IPO of approximately $[***] million to $[***] million (the “Valuation Range”), or approximately $[***] to $[***] per American Depositary Share (“ADS”) (the “Assumed IPO Price Range”), based on the number of ordinary shares outstanding on a fully diluted basis and before giving effect to an anticipated reverse stock split to be effected through the Reorganization described below. The Valuation Range remains under discussion between the Company and the lead underwriters of the IPO, and a bona fide price range will be included in a pre-effective amendment to the Registration Statement prior to any distribution of the preliminary prospectus in connection with the Company’s road show. The Company advises the Staff that the price range will be no more than $2.00, if the maximum price is $10.00 per ADS or less, or 20% of the high end of the range, if the maximum price is greater than $10.00 per ADS, unless otherwise approved by the Staff. As described in the Registration Statement, the Company plans to effect a reorganization of its outstanding share capital (the “Reorganization”) prior to the effectiveness of the Registration Statement. In the Reorganization, the different classes of the Company’s issued share capital (series A preferred, B ordinary and C ordinary) will be reorganized and converted into a single class of ordinary shares at a conversion ratio based on the midpoint of the bona fide price range for the IPO. The Company will re-register as a public limited company, and in connection therewith will change its name to Autolus Therapeutics plc. The Company currently anticipates that each ADS to be sold in the IPO will represent one ordinary share of Autolus Therapeutics plc. As is typical in IPOs, the Valuation Range was not derived using a formal determination of fair value, but was estimated by the Company with input from the lead underwriters. Among the factors that were considered in setting the Valuation Range were the following: • the general conditions of the securities market and the recent market prices of, and the demand for, publicly traded common stock of comparable companies; • the Company’s financial condition and prospects; • estimates of business potential and earnings prospects for the Company and the industry in which it operates; • recent performance of IPOs of companies in the biopharmaceutical industry; CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 May 30, 2018 Page Three • the Company’s progress in its clinical development programs; • other business developments impacting the Company; and • feedback from the Company’s “testing the waters” meetings with prospective investors. The Valuation Range does not take into account the current lack of liquidity for the Company’s ordinary shares and assumes a successful IPO, with no probability weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an acquisition transaction. Summary of Recent Option Grants The Company is providing the following supplemental information to the Staff to facilitate its review process. As there has been no public market for the Company’s ordinary shares to date, the estimated fair value of the C ordinary shares has been determined by the Company’s board of directors (the “Board”) as of the date of each equity grant, with input from management, considering the Company’s most recent third-party valuation of its B ordinary shares and C ordinary shares, as well as the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent sale of shares or third-party valuation through the date of the grant, including: • the progress of the Company’s research and development programs, including the status of preclinical studies and planned clinical trials for its product candidates; • the Company’s stage of development and commercialization and its business strategy; • external market conditions affecting the biopharmaceutical industry, and trends within that industry; • the Company’s financial position, including cash on hand, and its historical and forecasted performance and operating results; • the lack of an active public market for the C ordinary shares; • the likelihood of achieving a liquidity event, such as an IPO or a sale of the Company, in light of prevailing market conditions; and • the analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry. September 2017 Option Grants As described on pages 103-105 of the Registration Statement, the Company granted share options and restricted C ordinary shares during the fiscal year ended September 30, 2017. The most recent of these grants were made in September 2017, shortly before the closing of the Company’s preferred share financing transaction on September 25, 2017. For accounting purposes, the fair market value of the C ordinary shares underlying the September 2017 option grant was to be based on a third-party valuation that gave effect to the financing transaction (the “September 2017 Valuation”). As described on page 104 of the Registration Statement, the fair market value of the C ordinary shares was determined to be $1.74 per share in the September 2017 Valuation. The September 2017 Valuation was performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 May 30, 2018 Page Four Securities Issued as Compensation. The September 2017 Valuation used the option pricing method (“OPM”) to “backsolve” for the Company’s equity value implied by the purchase price of the series A preference shares in September 2017 ($3.08 per share). This implied company equity value of approximately $[***] million, based on the prevailing exchange rate at that time, was then allocated using the OPM to the securities outstanding based on their liquidation preferences and other rights. After giving effect to the issuance of new series A preference shares on September 25, 2017, the holders of series A preference shares would be entitled to receive a liquidation preference of approximately $175 million in any potential liquidity event before the holders of ordinary shares would begin to share in the proceeds of such an event. The September 2017 Valuation used an estimated equity volatility of [***]% and an expected time to liquidity event of [***] years and applied a [***]% discount for lack of marketability, resulting in an estimated fair value of $1.74 per C ordinary share. The Company did not consider any potential IPO scenario as part of the September 2017 Valuation, as the Company had not yet begun preparations for an offering. The Company supplementally advises the Staff that it did not select prospective lead underwriters for the IPO until [***]. February and March 2018 Option Grants Subsequent to September 30, 2017, the Company did not approve any further equity grants until February 2018. Between February 6, 2018 and March 21, 2018, the Board approved grants of options to employees, non-employee directors and consultants to purchase an aggregate of 2,548,100 C ordinary shares. All such grants were approved pending the completion of a third-party valuation of the C ordinary shares. This valuation was completed and received by the Board effective as of March 31, 2018 (the “March 2018 Valuation”). The March 2018 Valuation estimated that the fair value of the C ordinary shares was $2.63 per share. This third-party valuation was performed using a similar methodology as that used in the September 2017 Valuation, except that the March 2018 Valuation included an IPO scenario, reflecting that the Company had made progress toward a potential IPO, including the submission of a confidential draft registration statement on February 9, 2018. The March 2018 Valuation considered (i) scenarios in which the Company would complete an IPO at an average pre-IPO valuation of the Company of $[***] million and (ii) a stay-private scenario. The IPO scenarios were collectively weighted at [***]% probability, as was the stay-private scenario. For the stay-private scenario, the March 2018 Valuation used an OPM “backsolve” calculation to estimate the Company’s equity value implied by the purchase price of the series A preference shares in September 2017. This equity value was then allocated using the OPM to the securities outstanding based on their liquidation preferences and other rights, resulting in an implied value of $[***] per share. The March 2018 Valuation used an estimated equity volatility of [***]% and an expected time to liquidity event of [***] years and applied a [***]% discount for lack of marketability and a [***]% discount for lack of control, ultimately resulting in an estimated fair value of $[***] per share. The total equity value of the Company used in the IPO scenarios was informed by discussions earlier in March 2018 between management and the lead underwriters for the proposed IPO. In the IPO scenarios, the fair value per share was calculated by dividing the total estimated equity value of the Company by the number of fully diluted ordinary shares outstanding, and then discounting the implied per-share value at a rate intended to approximate the Company’s cost of equity between the March 31, 2018 valuation date and the expected IPO date of May 2018 (such discount being approximately [***]%) and a further discount for lack of marketability (approximately [***]%). After taking into account such discounts, the resulting estimated value in the IPO scenarios was $[***] per ordinary share. The IPO and stay-private scenarios were then [***] probability weighted [***]%, resulting in the final fair value estimate of $2.63 per share as of March 31, 2018. The Company notes for the Staff that the [***]% probability of an IPO occurring as of March 31, 2018 was, among other considerations, based on the fact that (1) the Company had only confidentially submitted a draft of the Registration Statement but had not yet publicly filed the Registration Statement, (2) there had been significant volatility in the public equity markets since the start of 2018 and (3) the Board had not made an affirmative decision to pursue the IPO, which occurred in May 2018 prior to the public filing of the Registration Statement. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 May 30, 2018 Page Five Anticipated May 2018 Option Grants In May 2018, the Remuneration Committee of the Board recommended to the Board the approval of option grants to recently hired employees and recently engaged consultants for an aggregate of 267,802 C ordinary shares. The Company expects the Board to approve such option grants in May 2018, prior to the commencement of the roadshow for the IPO. In connection with the Remuneration Committee’s recommendation, the Company received an updated third-party valuation of its ordinary shares as o
2018-05-17 - UPLOAD - Autolus Therapeutics plc
May 17, 2018
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics Ltd
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics Ltd
Registration Statement on Form F-1
Filed May 7, 2018
Amendment No. 1 to Registration Statement on Form F-1
Filed May 10, 2018
File No. 333-224720
Dear Dr. Itin:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1 filed May 7, 2018
Risk Factors
Adverse side effects or other safety risks associated with our product candidates..., page 28
1.We note your disclosure on page 127 that there has been one serious adverse event of
Grade 4 neutropenia deemed by the trial investigator to be related to AUTO2. Please also
disclose this information in this risk factor.
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
May 17, 2018 Page 2
FirstName LastName
Christian Itin, Ph.D.
Autolus Therapeutics Ltd
May 17, 2018
Page 2
Amendment No. 1 to Registration Statement on Form F-1 filed May 10, 2018
Exhibits
2.Please provide your auditors' consent in each amendment that you file. See Item
601(b)(23) of Regulation S-K as stipulated in Item 8a of Form F-1 and Compliance and
Disclosure Interpretation 233.03 of the Securities Act Rules.
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano - Cooley LLP
2018-05-10 - CORRESP - Autolus Therapeutics plc
CORRESP 1 filename1.htm CORRESP Darren K. DeStefano + 1 703 456 8034 ddestefano@cooley.com VIA EDGAR May 10, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Mary Beth Breslin Ms. Irene Paik Mr. Mark Brunhofer Ms. Mary Mast Re: Autolus Therapeutics Ltd. Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted April 27, 2018 CIK No. 0001730463 Ladies and Gentlemen: On behalf of our client, Autolus Therapeutics Limited (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated May 7, 2018 (the “Comment Letter”), relating to the above referenced Amendment No. 2 to Draft Registration Statement on Form F-1 (the “Amended Draft Registration Statement”) confidentially submitted to the Commission on February 9, 2018, resubmitted to the Commission on March 23, 2018, resubmitted to the Commission on April 27, 2018 and subsequently filed by the Company with the Commission on May 7, 2018 (File No. 333-224720) (the “Registration Statement”). In response to the comments set forth in the Comment Letter (the “Comments”), the Company is filing via EDGAR a pre-effective amendment to Registration Statement on Form F-1 (the “Amended Registration Statement”) with this response letter. For the Staff’s reference, we are also delivering a clean copy of the Amended Registration Statement and a copy marked to show all changes from the Amended Draft Registration Statement confidentially submitted on April 27, 2018. Set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Amended Registration Statement. May 10, 2018 Page 2 Prospectus Summary Our Pipeline, page 4 1. We note your disclosure on page 26 that you have received some positive preliminary data in a clinical trial of AUTO1 in pediatric ALL but you have no clinical data for AUTO1 in adult ALL. Your product pipeline chart suggests that your progress in your Phase 1 clinical trial for AUTO1 for pediatric ALL is the same as the progress you have made in adult ALL. Please revise your product pipeline chart here and on page 118 to reflect the progress you have made for each indication. Response to Comment 1: In response to the Staff’s comment, the Company has revised the product pipeline chart on pages 4, 111 and 119 of the Amended Registration Statement such that (i) for product candidates currently undergoing Phase 1/2 clinical trials and prior to completion of the proof-of-concept phases of these trials (such as AUTO1 for pediatric relapsed or refractory acute B lymphocytic leukemia), the arrows stop in the middle of the development phase and (ii) for product candidates that have received the required regulatory approvals and opened the Phase 1/2 clinical trials but have not yet begun patient enrollment or begun dosing patients (such as AUTO1 for adult relapsed or refractory acute B lymphocytic leukemia), the arrows stops at the beginning of the development phase. Our Strategy, page 4 2. We note your disclosure that you plan to develop AUTO1 for the treatment of adult ALL in collaboration with University College London. Please revise your disclosure as appropriate to clarify whether you plan to also further develop AUTO1 for the treatment of pediatric ALL. Response to Comment 2: In response to the Staff’s comment, the Company has revised the disclosure on pages 4, 112 and 121 of the Amended Registration Statement. Use of Proceeds, page 81 3. We note that you will use part of the net proceeds from the offering to contribute to the clinical trial conducted by UCL for AUTO1 in adult ALL. Please revise your disclosure to indicate the stage of development you expect to achieve using the net proceeds of the offering. To the extent the proceeds will not be sufficient to complete this stage of development, please also disclose the amount and sources of additional funds that may be needed to complete the trials. Refer to Instruction 3 to Item 504 of Regulation S-K. Response to Comment 3: In response to the Staff’s comment, the Company has revised the disclosure on page 81 of the Amended Registration Statement. May 10, 2018 Page 3 Business Clinical Experience in Phase 1 Clinical Trial in Pediatric ALL, page 120 4. Please expand your disclosure regarding the Phase 1 clinical trial of AUTO1 in Pediatric ALL to provide information, as appropriate, about the number of patients UCL plans to enroll in the study, clinical endpoints, the duration of treatment, whether the preliminary data demonstrates statistical significance, when the study is expected to be completed and the development strategy for the indication. In addition, we note your statement that preliminary data from the CARPALL trial suggests a “favorable safety profile.” Please revise your disclosure to eliminate any suggestion that your product candidate has been or will ultimately be determined to be safe or to have demonstrated safety for purposes of receiving marketing approval by the FDA or comparable agency, including comparisons to the current standard of care. Response to Comment 4: In response to the Staff’s comment, the Company has revised the disclosure on page 120 and 121 of the Amended Registration Statement. Phase 1 Clinical Trial in Adult ALL, page 122 5. Please expand your disclosure regarding the Phase 1 clinical trial of AUTO1 in adult ALL to provide information about the clinical endpoints of the study. Response to Comment 5: In response to the Staff’s comment, the Company has revised the disclosure on page 122 of the Amended Registration Statement. Manufacturing Agreements, Page 144 6. We note that you have requested confidential treatment for the length of the initial term and renewal terms of the supply agreement with Miltenyi. However, confidential treatment is generally not appropriate for the term of a material contract. Accordingly, please revise your disclosure to provide this information. Alternatively, please explain why this information is not material to investors. Response to Comment 6: The Company respectfully acknowledges this comment and is concurrently submitting an amended confidential treatment application to the Commission. It has revised the disclosure on page 144 of the Amended Registration Statement in response to the Staff’s comment. * * * * May 10, 2018 Page 4 Please direct any questions or comments concerning the Amended Registration Statement or this response letter to either the undersigned at +1 703 456 8034, Brian Leaf at +1 703 456 8053 or Courtney Thorne at + 1 617 937 2318. Very truly yours, /s/ Darren K. DeStefano Darren K. DeStefano cc: Christian Itin, Autolus Therapeutics Limited Brian F. Leaf, Cooley LLP Courtney T. Thorne, Cooley LLP Patrick O’Brien, Ropes & Gray LLP Emily Oldshue, Ropes & Gray LLP
2018-05-08 - UPLOAD - Autolus Therapeutics plc
May 7, 2018
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics Ltd
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics Ltd
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted April 27, 2018
CIK No. 0001730463
Dear Dr. Itin:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement submitted April 27, 2018
Prospectus Summary
Our Pipeline, page 4
1.We note your disclosure on page 26 that you have received some positive preliminary data
in a clinical trial of AUTO 1 in pediatric ALL but you have no clinical data for AUTO1 in
adult ALL. Your product pipeline chart suggests that your progress in your Phase 1
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
May 7, 2018 Page 2
FirstName LastNameChristian Itin, Ph.D.
Autolus Therapeutics Ltd
May 7, 2018
Page 2
clinical trial for AUTO1 for pediatric ALL is the same as the progress you have made in
adult ALL. Please revise your product pipeline chart here and on page 118 to reflect the
progress you have made for each indication.
Our Strategy, page 4
2.We note your disclosure that you plan to develop AUTO1 for the treatment of adult ALL
in collaboration with University College London. Please revise your disclosure as
appropriate to clarify whether you plan to also further develop AUTO1 for the treatment
of pediatric ALL.
Use of Proceeds, page 81
3.We note that you will use part of the net proceeds from the offering to contribute to the
clinical trial conducted by UCL for AUTO1 in adult ALL. Please revise your disclosure
to indicate the stage of development you expect to achieve using the net proceeds of the
offering. To the extent the proceeds will not be sufficient to complete this stage of
development, please also disclose the amount and sources of additional funds that may be
needed to complete the trials. Refer to Instruction 3 to Item 504 of Regulation S-K.
Business
Clinical Experience in Phase 1 Clinical Trial in Pediatric ALL, page 120
4.Please expand your disclosure regarding the Phase 1 clinical trial of AUTO1 in Pediatric
ALL to provide information, as appropriate, about the number of patients UCL plans to
enroll in the study, clinical endpoints, the duration of treatment, whether the preliminary
data demonstrates statistical significance, when the study is expected to be completed and
the development strategy for the indication. In addition, we note your statement that
preliminary data from the CARPALL trial suggests a "favorable safety profile." Please
revise your disclosure to eliminate any suggestion that your product candidate has been or
will ultimately be determined to be safe or to have demonstrated safety for purposes of
receiving marketing approval by the FDA or comparable agency, including comparisons
to the current standard of care.
Phase 1 Clinical Trial in Adult ALL, page 122
5.Please expand your disclosure regarding the Phase 1 clinical trial of AUTO1 in adult ALL
to provide information about the clinical endpoints of the study.
Manufacturing Agreements, page 144
6.We note that you have requested confidential treatment for the length of the initial term
and renewal terms of the supply agreement with Miltenyi. However, confidential
treatment is generally not appropriate for the term of a material contract. Accordingly,
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
May 7, 2018 Page 3
FirstName LastName
Christian Itin, Ph.D.
Autolus Therapeutics Ltd
May 7, 2018
Page 3
please revise your disclosure to provide this information. Alternatively, please explain
why this information is not material to investors.
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if
you have questions regarding comments on the financial statements and related matters.
Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any
other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano - Cooley LLP
2018-04-09 - UPLOAD - Autolus Therapeutics plc
April 9, 2018
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics Ltd
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics Ltd
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted March 23, 2018
CIK No. 0001730463
Dear Dr. Itin:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form F-1 submitted March 23, 2018
Business
Our License Agreement with UCL Business plc, page 135
1.We note your revised disclosure that the sublicensing income payable to UCLB ranges
from low-double-digits to mid-single digits in response to our prior comment 9. Please
revise your description of the high end of the range to provide a range within ten
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
June 16, 2017 Page 2
FirstName LastName
Christian Itin, Ph.D.
Autolus Therapeutics Ltd
April 9, 2018
Page 2
percentage points. We also note your response that the duration of the royalty term will
be subject to a confidential treatment request. Confidential treatment is generally not
appropriate for material information such as the royalty term of material contracts. Please
revise your disclosure to provide the royalty term of your license agreement with UCLB,
or tell us why you believe this information is not material to investors.
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano - Cooley LLP
2018-03-09 - UPLOAD - Autolus Therapeutics plc
March 8, 2018
Christian Itin, Ph.D.
Chief Executive Officer
Autolus Therapeutics Ltd
Forest House
58 Wood Lane
White City
London W12 7RZ
United Kingdom
Re:Autolus Therapeutics Ltd
Draft Registration Statement on Form F-1
Submitted February 9, 2018
CIK No. 0001730463
Dear Dr. Itin:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1 submitted February 9, 2018
Prospectus Summary
Implications of Being an Emerging Growth Company and a Foreign Private Issuer, page 9
1.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
June 16, 2017 Page 2
FirstName LastNameChristian Itin, Ph.D.
Autolus Therapeutics Ltd
March 8, 2018
Page 2
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Corporate Reorganization
Reduction of Capital of Autolus Therapeutics Limited and Autolus Holdings (UK) Limited, page
80
2.Please tell us how you intend to account for your expected capital reduction and how you
will reflect it in your pro forma capitalization table. In your response specifically tell us
the accounts you expect to debit and credit and reference for us the authoritative literature
you rely upon to support your accounting.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Components of Our Results of Operations
Grant Income, page 89
3.Please tell us whether your grants are repayable under any circumstances. If so, revise
your disclosure throughout your submission to describe the contingent repayment terms
and separately explain to us why your recognition of grant income is appropriate,
referencing the authoritative literature you rely upon to support your accounting.
Critical Accounting Policies and Significant Judgments and Estimates
Share-Based Compensation, page 97
4.We may have additional comments on your accounting for equity issuances including
stock compensation and beneficial conversion features. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between recent valuations of your ordinary shares leading up to the IPO and the estimated
offering price.
5.Please explain to us why the fair value of the C ordinary shares is higher than that of your
B ordinary shares when it appears from disclosure in Note 7 on page F-19 that your B
ordinary shares have voting rights and your C ordinary shares do not.
Preclinical Studies of AUTO3, page 119
6.We note your statements that AUTO3 cells targeting both CD19 and CCD22 were
"effective in eliminating tumor cells expressing these antigens" and that the "efficacy of
AUTO3 cells was also established in an in vivo tumor xenograft mouse model." Please
revise your disclosure to eliminate any suggestion that your product candidate has been or
will ultimately be determined to be effective or to have demonstrated efficacy for
purposes of receiving marketing approval by the FDA or comparable agency.
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
June 16, 2017 Page 3
FirstName LastNameChristian Itin, Ph.D.
Autolus Therapeutics Ltd
March 8, 2018
Page 3
Intellectual Property, page 132
7.We note your disclosure that your patent portfolio does not yet include any granted U.S.
patents. Please expand your disclosure to identify any granted patents that cover material
non-U.S. jurisdictions and provide the jurisdiction(s), the product candidate it covers, the
type of protection you have (such as composition of matter, use or process), whether you
own or license the patent and the expiration date.
Our License Agreement with UCL Business plc, page 133
8.Please revise your disclosure relating to your license agreement with UCLB to provide the
percentage range of sublicensing income you must pay UCLB and the royalty term.
9.We note your disclosure on page 89 that your research grant income increased due to a
collaboration agreement with the U.K. government. To the extent that these grants
are governed by your agreement with UCLB, please expand your disclosure here to
discuss the material terms of the research grants. If these grants are governed by another
collaboration agreement, please revise the appropriate section of your document to discuss
the material terms and file the agreement as an exhibit, or tell us why it is not required to
be filed.
Principal Shareholders, page 172
10.Please revise to identify the natural or legal person or persons who have voting and
dispositive control over the shares held by the entities in the table. Refer to Item 7.A.3 of
Form 20-F.
Management, page 194
11.We note that certain of your directors appear to have affiliations with Syncona Limited
and Arix Bioscience plc. Please revise this section to discuss any arrangements or
understandings with major shareholders, customers, suppliers or others, pursuant to which
any director or senior manager was selected as a director or member of senior
management. Refer to Item 6.A.5 of Form 20-F.
Note 2: Summary of Significant Accounting Policies
Income Tax Credit, page F-15
12.It appears from your disclosure here and in your Research and Developments Costs policy
disclosure on page F-12 that you classify part of your refundable research and
development (R&D) tax credits as R&D expenses and part as income tax benefits in your
statements of operations and comprehensive loss. Please address the following:
•Tell us how you determine the classification of these refundable credits between R&D
expense and income tax benefits.
FirstName LastNameChristian Itin, Ph.D.
Comapany NameAutolus Therapeutics Ltd
June 16, 2017 Page 4
FirstName LastName
Christian Itin, Ph.D.
Autolus Therapeutics Ltd
March 8, 2018
Page 4
•Tell us why it is appropriate to reflect a portion of these refundable credits as income
tax benefits when the credit appears to be based on the level of R&D expenditures and
not income as stipulated in ASC 740-10-15-3a.
•Revise your R&D costs policy disclosure to clarify that the R&D tax credits classified
as R&D expenses are reductions to R&D expenses or explain to us how they increase
these expenses.
Notes to Financial Statements
9. License Agreements, page F-25
13.You state on page 134 that you are obligated to pay UCLB milestone payments upon the
receipt of specified regulatory approvals in an aggregate amount of £15 million, the start
of commercialization in an aggregate amount of £18 million, and the achievement of net
sales levels in an aggregate amount of £51 million. Please provide disclosure in the notes
to the financial statements or tell us why the amounts are not required to be
disclosed pursuant to ASC 440-10-50-1.
General
14.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Darren DeStefano - Cooley LLP