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| LEI | 21380056R45ONMT94Z50 |
| CIK | 1748907 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Orchard Therapeutics plc - Depositary Receipt (Common Stock)
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| November 14, 2024 |
SC 13G/A 1 ef20038686sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1)* Orchard Therapeutics plc (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P200 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Stat |
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| November 14, 2024 |
SC 13G/A 1 deeptrack-ortx093024a1.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, par value £0.10 per share (represented by American Depositary Shares) (Title of Class of Securities) 68570P200 (CUSIP Number) September 30, 2024 (Date of Eve |
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| February 14, 2024 |
US68570P2002 / Orchard Therapeutics plc / RA CAPITAL MANAGEMENT, L.P. - SC 13G/A Passive Investment SC 13G/A 1 tm246065d27sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P200 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this St |
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| February 14, 2024 |
EX-99.1 2 tm246065d27ex1.htm EXHIBIT 1 EXHIBIT 1 AGREEMENT This Joint Filing Agreement, dated as of February 14, 2024, is by and among RA Capital Management, L.P., Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the foregoing are collectively referred to herein as the “Filers”). Each of the Filers may be required to file with the United States Securities and Exchange Commissio |
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| February 14, 2024 |
US68570P2002 / Orchard Therapeutics plc / Blue Owl Capital Holdings LP - SC 13G Passive Investment SC 13G 1 ef20021762sc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Orchard Therapeutics plc (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P200 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) |
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| February 8, 2024 |
US68570P2002 / Orchard Therapeutics plc / Beryl Capital Management LLC Passive Investment SC 13G/A 1 ortx13ga.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Orchard Therapeutics PLC (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P2001 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the |
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| February 5, 2024 |
OMB APPROVAL OMB Number: 3235-0167 Expires: July 31, 2024 Estimated average burden hours per response 1. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
CONTINGENT VALUE RIGHTS AGREEMENT Exhibit 2.2 Execution Version CONTINGENT VALUE RIGHTS AGREEMENT THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of December 15, 2023 (this “Agreement”), is entered into by and between Kyowa Kirin Co., Ltd., a Japanese joint stock company (kabushiki kaisha) (“Purchaser”), and Wilmington Savings Fund Society, FSB (the “Rights Agent”). RECITALS WHEREAS, Purchaser and Orchard Therapeutics plc, a publ |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 24, 2024 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 24, 2024 |
As filed with the Securities and Exchange Commission on January 24, 2024 As filed with the Securities and Exchange Commission on January 24, 2024 Registration No. |
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| January 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 22, 2024 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| December 19, 2023 |
Regulation FD Disclosure, Other Events, Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 19, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| December 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 6, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| December 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| November 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
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| November 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 30, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 30, 2023 |
Exhibit 99.1 Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH Previously reported results from ongoing proof-of-concept study showed extensive metabolic correction, continued cognitive, motor, and physical development, as well as early improvements in skeletal health Additionally, study investigators presented favorable outcomes for other disease manifestations n |
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| November 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
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| November 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 15, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 16, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defi |
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| November 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One)c ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable (State or other jurisdiction of incorporation or organization) (I. |
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| November 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 13, 2023 |
Exhibit 99.1 Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments Reported $5.6 million in quarterly Libmeldy net revenue and $12.7 million year-to-date Planned acquisition by Kyowa Kirin valued at up to $477.6 million with an anticipated closing in the first quarter of 2024 Biologics License Application for OTL-200 in MLD accepted by U.S |
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| November 3, 2023 |
EX-FILING FEES Exhibit 107 CALCULATION OF FILING FEE TABLES Schedule 14A (Form Type) ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) Table 1 – Transaction Valuation Proposed Maximum Aggregate Value of Transaction Fee Rate Amount of Filing Fee Fees to Be Paid $400,432,702. |
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| November 3, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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| October 26, 2023 |
Exhibit 99.1 Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023 New clinical data beyond previously reported neurological and skeletal results demonstrate favorable outcomes for multiple disease manifestations not effectively addressed by the current standard of care BOSTON and LONDON, October 26, 2023, (GLOBE NEWS |
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| October 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 26, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| October 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
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| October 16, 2023 |
US68570P2002 / Orchard Therapeutics plc / Beryl Capital Management LLC Passive Investment SC 13G 1 ortx13g.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Orchard Therapeutics PLC (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P2001 (CUSIP Number) October 5, 2023 (Date of Event Which Requires Filing of this Statement) Check the approp |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Prox |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 5, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporatio |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 5, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporatio |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Prox |
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| October 5, 2023 |
Kyowa Kirin to Acquire Orchard Therapeutics Exhibit 99.1 Kyowa Kirin to Acquire Orchard Therapeutics -Orchard Therapeutics is a global gene therapy leader with experience successfully developing and commercializing medicines for rare diseases- -Acquisition enriches Kyowa Kirin’s portfolio, enables the development of numerous promising candidates with a clinically differentiated platform, and helps resource the ongoing and future launches of |
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| October 5, 2023 |
Exhibit 2.1 TRANSACTION AGREEMENT by and between KYOWA KIRIN CO., LTD. and ORCHARD THERAPEUTICS PLC Dated as of October 5, 2023 TABLE OF CONTENTS Page ARTICLE I THE TRANSACTION 2 Section 1.01 The Transaction 2 Section 1.02 Closing 2 Section 1.03 Delivery of Court Order 2 ARTICLE II TRANSFER OF SCHEME SHARES 2 Section 2.01 Transfer of Scheme Shares 2 Section 2.02 Treatment of Equity Awards and W |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Prox |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Prox |
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| October 5, 2023 |
Form of Irrevocable Undertaking, dated October 5, 2023. Exhibit 10.1 To: Kyowa Kirin Co., Ltd. (the “Purchaser”) October 5, 2023 Offer for Orchard Therapeutics plc (the “Company”) I, the undersigned, understand that the Purchaser is considering the Acquisition substantially on the terms and conditions set out or referred to in a draft of the transaction agreement, a copy of which is annexed hereto (the “Transaction Agreement”), and/or on such other ter |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Prox |
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| September 18, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 18, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorpora |
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| September 18, 2023 |
Exhibit 99.1 Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and cognitive developmen |
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| August 21, 2023 |
Table of Contents Filed pursuant to Rule 424(b)(3) Registration No. 333-273891 PROSPECTUS 20,825,049 American Depositary Shares Representing 208,250,490 Ordinary Shares Offered by the Selling Securityholders This prospectus relates to the proposed resale or other disposition by the selling securityholders identified herein of (i) up to 99,166,900 of our ordinary shares, nominal value £0.10 per sha |
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| August 17, 2023 |
Orchard Therapeutics plc 245 Hammersmith Road London W6 8PW United Kingdom Orchard Therapeutics plc 245 Hammersmith Road London W6 8PW United Kingdom August 17, 2023 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| August 10, 2023 |
As filed with the Securities and Exchange Commission on August 10, 2023 As filed with the Securities and Exchange Commission on August 10, 2023 Registration No. |
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| August 10, 2023 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Orchard Therapeutics plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Share(3) Maximum Aggregate Offering Price(3) Fee Rate Amount of Registration Fee Fees to Be Paid Equity Ordinary Shares, nominal value £0. |
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| August 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable (State or other jurisdiction of incorporation or organization) (I. |
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| August 10, 2023 |
EX-FILING FEES Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) Orchard Therapeutics plc (Exact name of Registrant as Specified in its Charter) Newly Registered Securities Security Type Security Class Title(1) Fee Calculation Rule Amount Registered(2) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Ordinary shares, nominal value £0. |
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| August 10, 2023 |
As filed with the Securities and Exchange Commission on August 10, 2023 S-3 Table of Contents As filed with the Securities and Exchange Commission on August 10, 2023 Registration No. |
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| August 3, 2023 |
We aspire to end the devastation caused by genetic and other severe diseases through the curative potential of HSC gene therapy. |
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| August 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 3, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| August 3, 2023 |
Exhibit 99.1 Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA Reported $6.6M in Q2’23 Libmeldy net sales, representing the highest quarter to date $34.0M of additional capital from second closing of strategic financing extends runway to mid-2025 Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests sign |
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| June 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 26, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| June 26, 2023 |
Exhibit 99.1 Orchard Therapeutics Announces Second Closing of Strategic Financing, Resulting in $34 Million of Additional Capital Funding from second closing extends cash runway to mid-2025 to advance the company’s HSC gene therapy portfolio through several potential value-creating milestones OTL-200 (MLD) BLA submission initiated and on track for completion in mid-2023 with potential for U.S. app |
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| June 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 14, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 23, 2023 |
Exhibit 99.3 Orchard Therapeutics Announces Positive Clinical and Preclinical Data in Programs Targeting Neurometabolic and CNS Disorders at ASGCT New OTL-203 proof-of-concept data demonstrate extensive metabolic correction in the skeletal system of patients with MPS-IH including normal growth rates, improvement in joint function and progressive acquisition of motor skills Updated OTL-201 data fro |
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| May 23, 2023 |
ASGCT Data Review IR webcast May 23, 2023 Exhibit 99.1 ASGCT IR Event Agenda TIME AGENDA TOPIC SPEAKERS 8:00 – 8:10 a.m. Orchard’s HSC Gene Therapy Platform and ASGCT Overview Bobby Gaspar CEO 8:10 – 8:30 a.m. Clinical Data: OTL-203 (MPS-IH) + OTL-201 (MPS-IIIA) Leslie Meltzer CMO 8:30 – 8:40 a.m. Preclinical: OTL-204 (GRN-FTD) + OTL-104 (NOD2-CD) Bobby Gaspar CEO 8:40 – 9:00 a.m. Q&A Forward-look |
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| May 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 18, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 23, 2023 |
Exhibit 99.2 Orchard Therapeutics Presents Data from Research Programs at ASGCT Demonstrating the Ability of HSC Gene Therapy to Address Larger Indications Preclinical proof-of-concept data show the therapeutic potential of OTL-104 for NOD2 Crohn’s disease, a severe and treatment-refractory form of the disease In vivo data demonstrate the development of CAR-Treg cells from genetically engineered H |
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| May 15, 2023 |
Exhibit 99.1 Orchard Therapeutics Reports First Quarter 2023 Financial Results and Announces Initiation of Rolling Submission for Biologics License Application of OTL-200 for Metachromatic Leukodystrophy to U.S. FDA OTL-200 Biologics License Application (BLA) submission completion anticipated in mid-2023 Libmeldy revenue and commercial patients treated expected to grow year-over-year in 2023 New c |
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| May 15, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable (State or other jurisdiction of incorporation or organization) (I. |
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| April 27, 2023 |
DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 13, 2023 |
PRE 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 10, 2023 |
ORTX / Orchard Therapeutics plc - ADR / FEDERATED HERMES, INC. Passive Investment OMB APPROVAL OMB Number: 3235-0145 Estimated average burden hours per response ….11 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2*) ORCHARD THERAPEUTICS, PLC (Name of Issuer) COMMON STOCK (Title of Class of Securities) 68570P101 (CUSIP Number) March 31, 2023 (Date of Event Which Requires Filing of thi |
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| March 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 23, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| March 20, 2023 |
ORTX / Orchard Therapeutics plc - ADR / RA CAPITAL MANAGEMENT, L.P. - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, nominal value £0.10 per share (Title of Class of Securities) 68570P101 (CUSIP Number) March 10, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate |
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| March 20, 2023 |
US68570P2002 / Orchard Therapeutics plc / Deep Track Capital, LP Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| March 14, 2023 |
Exhibit 10.19 CERTAIN CONFIDENTIAL INFORMATION MARKED BY [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. AMENDMENT 1 TO THE MANUFACTURING AND TECHNOLOGY DEVELOPMENT MASTER AGREEMENT This amendment is effective as of the date the last signature is made ("Effective Date") between Orchard Therapeutics (Eu |
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| March 14, 2023 |
Amendment No. 1 to Deposit Agreement Exhibit 4.2 ORCHARD THERAPEUTICS PLC and CITIBANK, N.A., as Depositary, and THE HOLDERS AND BENEFICIAL OWNERS OF AMERICAN DEPOSITARY SHARES OUTSTANDING UNDER THE TERMS OF THE DEPOSIT AGREEMENT, DATED AS OF November 2, 2018 Amendment No. 1 to the Deposit Agreement Dated as of March 10, 2023 Exhibit 4.2 ARTICLE I DEFINITIONS 2 Section 1.1 Definitions 2 Section 1.2 Effective Date 2 ARTICLE II AMENDME |
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| March 14, 2023 |
Exhibit 10.14 CERTAIN CONFIDENTIAL INFORMATION MARKED BY [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Originally dated 24 May 2019 as amended and restated on 28 May 2021 and on the Second Effective Date (as defined below) Orchard Therapeutics plc as the Company - and - The entities listed as Origina |
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| March 14, 2023 |
Description of the registrant’s securities Exhibit 4.5 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED The following description is a summary of the material terms of Orchard Therapeutics plc (the “Company”) American Depositary Shares (“ADSs”), each representing ten ordinary shares, nominal value £0.10 per share. This description also summarizes relevant provisions of English l |
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| March 14, 2023 |
Exhibit 21.1 Subsidiaries Name of Subsidiary Jurisdiction of Incorporation or Organization Orchard Therapeutics (Europe) Limited England and Wales Orchard Therapeutics North America California (United States) Orchard Therapeutics (Netherlands) B.V. Netherlands Orchard Therapeutics (France) SAS France Orchard Therapeutics (Italy) S.r.l Italy Orchard Therapeutics (Germany) GmbH Germany Orchard Thera |
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| March 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38722 ORCHARD THERAPE |
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| March 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 10, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| March 6, 2023 |
EX-10.1 Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of March 6, 2023 (the “Effective Date”), among Orchard Therapeutics plc, a public limited company incorporated under the laws of England and Wales (the “Company”), and each purchaser identified on Exhibit A attached hereto (each a “Purchaser” and collectively the “Purchasers”). WHER |
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| March 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| March 6, 2023 |
EX-99.1 Exhibit 99.1 Orchard Therapeutics Announces Strategic Financing Totalling up to $188 Million Proceeds to accelerate commercialization of Libmeldy and advance the company’s HSC gene therapy R&D portfolio Initial closing of $34 million to support execution and extend cash runway into 2025 with potential for significant additional capital at increasing valuations BOSTON and LONDON, March 6, 2 |
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| March 6, 2023 |
EX-4.1 Exhibit 4.1 FORM THESE SECURITIES REPRESENTED HEREBY AND THE SECURITIES ISSUABLE UPON EXERCISE OF THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE BUT HAVE BEEN OR WILL BE ISSUED IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND, ACCORDINGLY, MAY NOT BE TRANSFERRED |
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| March 6, 2023 |
Exhibit 99.1 Orchard Therapeutics Provides Business Update and Reports 2022 Financial Results OTL-200 pre-BLA meeting granted for second quarter of 2023 following productive clinical Type B meeting with the U.S. Food and Drug Administration (FDA) Strategic financing from leading healthcare investors provides up to $188 million of additional capital upon achievement of key milestones $18.8M of Libm |
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| March 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| February 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| February 27, 2023 |
Exhibit 99.1 Orchard Therapeutics Announces Agreement Enabling Reimbursed Access to Libmeldy for All Eligible MLD Patients in Sweden BOSTON and LONDON, February 27, 2023, (GLOBE NEWSWIRE) - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced it has reached an agreement with the New Therapies (NT) Council which will result in reimbursed access to Libmeldy® (atidarsage |
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| February 24, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 24, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| February 24, 2023 |
Exhibit 99.1 Orchard Therapeutics Announces Presentation of Updated Integrated Analysis of OTL-200 in MLD and Reports Progress with Newborn Screening Efforts at the 19th Annual WORLDSymposium™ Administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 11 years of follow-up (median 6.15 years) Composite primary endpo |
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| February 13, 2023 |
ORTX / Orchard Therapeutics plc / CHI Advisors LLC - CHI ADVISORS LLC Passive Investment SC 13G/A 1 ortxa121323.htm CHI ADVISORS LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Orchard Therapeutics plc (Name of Issuer) Ordinary Shares, nominal value 0.10 per share (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Sta |
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| February 10, 2023 |
As filed with the Securities and Exchange Commission on February 10, 2023 Registration No. |
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| February 10, 2023 |
Exhibit (b) ORCHARD THERAPEUTICS PLC As of December 12, 2022 Citibank, N.A. – ADR Department 388 Greenwich Street New York, New York 10013 Attn: Ryan Everett Program ADSs (CUSIP No.: 68570P101) Ladies and Gentlemen: Reference is hereby made to the Deposit Agreement, dated as of November 2, 2018, as amended and supplemented from time to time (the “Deposit Agreement”), by and among Orchard Therapeut |
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| February 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 10, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| February 10, 2023 |
Exhibit (a)(ii) DEPOSIT AGREEMENT by and among ORCHARD THERAPEUTICS PLC and CITIBANK, N. |
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| February 10, 2023 |
Exhibit (a)(i) ORCHARD THERAPEUTICS PLC and CITIBANK, N.A., as Depositary, and THE HOLDERS AND BENEFICIAL OWNERS OF AMERICAN DEPOSITARY SHARES OUTSTANDING UNDER THE TERMS OF THE DEPOSIT AGREEMENT, DATED AS OF November 2, 2018 Amendment No. 1 to the Deposit Agreement Dated as of [·], 2023 Table of Contents Page ARTICLE I DEFINITIONS 2 Section 1.1 Definitions 2 Section 1.2 Effective Date 2 ARTICLE I |
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| February 10, 2023 |
Orchard Therapeutics Announces Proposed ADS Ratio Change EXHIBIT 99.1 Orchard Therapeutics Announces Proposed ADS Ratio Change BOSTON and LONDON, February 10, 2023, (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that it plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value £0.10 per share, from the current ADS Ratio of one (1) AD |
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| February 10, 2023 |
ORTX / Orchard Therapeutics plc / Flynn James E Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. |
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| February 9, 2023 |
ORTX / Orchard Therapeutics plc / Zentree Investments Ltd - AMENDMENT NO. 2 Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Orchard Therapeutics Plc (Name of Issuer) American Depository Shares (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuan |
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| February 1, 2023 |
ORTX / Orchard Therapeutics plc / FEDERATED HERMES, INC. Passive Investment OMB APPROVAL OMB Number: 3235-0145 Estimated average burden hours per response ….11 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1*) ORCHARD THERAPEUTICS, PLC (Name of Issuer) COMMON STOCK (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of |
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| January 9, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporatio |
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| January 9, 2023 |
EX-99.1 2 ortx-ex991.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Highlights Recent Progress Across HSC Gene Therapy Portfolio and Outlines Key 2023 Milestones Libmeldy® revenue totaled $5.8M in Q4 2022 and $18.8M for the full year with commercial expansion activities continuing in Europe Clinical Type B meeting with U.S. FDA to take place in early 2023 prior to OTL-200 (MLD) BLA submission Ended |
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| January 9, 2023 |
We aspire to end the devastation caused by genetic and other severe diseases through the curative potential of HSC gene therapy. |
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| January 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 5, 2023 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporatio |
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| January 5, 2023 |
EX-99.1 2 ortx-ex991.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Announces U.S. FDA Clearance of IND Application for OTL-203 in MPS-IH Global registrational trial expected to commence in the second half of 2023 BOSTON and LONDON, January 5, 2023, (GLOBE NEWSWIRE) - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has c |
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| December 20, 2022 |
ORTX / Orchard Therapeutics plc / Zentree Investments Ltd - AMENDMENT NO. 1 Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Orchard Therapeutics Plc (Name of Issuer) American Depository Shares (Title of Class of Securities) 68570P101 (CUSIP Number) December 15, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuan |
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| December 12, 2022 |
EX-99.1 OTL-201 MPS-IIIA Data IR webcast December 12, 2022 Exhibit 99.1 | Forward-looking Statements Certain information set forth in this presentation and in statements made orally during this presentation contain “forward-looking statements”. Except for statements of historical fact, information contained herein constitutes forward-looking statements and may include, but is not limited to, expec |
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| December 12, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 12 , 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorpora |
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| December 12, 2022 |
EX-99.2 Exhibit 99.2 Orchard Therapeutics Announces Promising Early Neurocognitive Outcomes from Ongoing Proof-of-concept Study of OTL-201 in MPS-IIIA All patients achieved sustained engraftment and supraphysiological SGSH enzyme levels with median 1.5 years follow-up Four out of five patients demonstrated gain of cognitive skills in line with development in healthy children with one patient showi |
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| November 14, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| November 14, 2022 |
EX-99.1 Exhibit 99.1 Orchard Therapeutics Reports Third Quarter 2022 Financial Results and Reviews Recent Business Highlights Libmeldy® product sales totaled $4.8M in Q3 and $13.0M YTD with market expansion activities continuing in Europe First case of MLD confirmed from newborn screening study provides critical evidence to advance adoption of universal screening in key countries Clinical Type B m |
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| November 14, 2022 |
ORTX / Orchard Therapeutics plc / RA CAPITAL MANAGEMENT, L.P. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 5)* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, par value £0.10 (represented by American Depositary Shares) (Title of Class of Securities) 68570P101 (CUSIP Number) November 14, 2022 (Date of Event Which Requires Filing of this Statement) Che |
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| November 14, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 14, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| October 6, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 4, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporatio |
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| October 6, 2022 |
American Depositary Shares representing Ordinary Shares Table of Contents Filed pursuant to Rule 424(b)(5) Registration No. 333-263967 PROSPECTUS SUPPLEMENT (To prospectus dated April 29, 2022) $30,000,000 American Depositary Shares representing Ordinary Shares We have entered into a sales agreement with Guggenheim Securities, LLC, or Guggenheim Securities, relating to the sale of American Depositary Shares, or ADSs, offered by this prospectus suppleme |
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| October 6, 2022 |
Sales Agreement, dated October 6, 2022 EX-1.1 2 d351981dex11.htm EX-1.1 Exhibit 1.1 ORCHARD THERAPEUTICS PLC $30,000,000 AMERICAN DEPOSITARY SHARES EACH REPRESENTING ONE ORDINARY SHARE (NOMINAL VALUE £0.10 PER SHARE) SALES AGREEMENT October 6, 2022 Guggenheim Securities, LLC 330 Madison Avenue New York, NY 10017 Ladies and Gentlemen: Orchard Therapeutics plc, a public limited company incorporated under the laws of England and Wales (th |
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| October 6, 2022 |
Exhibit 10.1 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (?Agreement?) is made by and between Orchard Therapeutics plc (the ?Parent?), Orchard Therapeutics North America (the ?U.S. Subsidiary?), and Frank Thomas (the ?Executive?), and is effective as of October 4, 2022 (the ?Effective Date?). The Parent, the U.S. Subsidiary, and their respective subsidi |
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| September 9, 2022 |
ORTX / Orchard Therapeutics plc / Zentree Investments Ltd Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Orchard Therapeutics Plc (Name of Issuer) American Depository Shares (Title of Class of Securities) 68570P101 (CUSIP Number) September 1, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant |
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| August 4, 2022 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) Orchard Therapeutics plc (Exact name of Registrant as Specified in its Charter) Newly Registered Securities Security Type Security Class Title(1) Fee Calculation Rule Amount Registered(2) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Ordinary shares, nominal value ?0. |
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| August 4, 2022 |
As filed with the Securities and Exchange Commission on August 4, 2022 As filed with the Securities and Exchange Commission on August 4, 2022 Registration No. |
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| August 4, 2022 |
LEASE Relating to premises known as Part 3rd Floor 245 Hammersmith Road, London W6 8PW Dated: 5 April 2022 (1) 245 HAMMERSMITH ROAD NOMINEE 1 LIMITED, 245 HAMMERSMITH ROAD NOMINEE 2 LIMITED and 245 HAMMERSMITH ROAD LIMITED PARTNERSHIP (acting through its general partner 245 HAMMERSMITH ROAD GENERAL PARTNER LIMITED) (2) ORCHARD THERAPEUTICS (EUROPE) LIMITED CONTENTS ?1 DEFINITIONS 1 ?2 INTERPRETATION 8 ?3 DEMISE, TERM AND RENT 9 ?4 TENANT'S OBLIGATIONS 10 ?4. |
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| August 4, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 4, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| August 4, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| August 4, 2022 |
Exhibit 99.1 Orchard Therapeutics Reports Second Quarter 2022 Financial Results and Reviews Recent Business Highlights Additional Libmeldy? reimbursement discussions advancing across Europe with product sales totaling $3.1M in Q2 and $8.2M YTD OTL-200 U.S. BLA filing for MLD on track for late 2022 / early 2023 Seven abstracts accepted at SSIEM highlight potential of HSC gene therapy platform to ad |
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| June 10, 2022 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 7, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 12, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| May 12, 2022 |
Exhibit 99.1 Orchard Therapeutics Reports First Quarter 2022 Financial Results and Highlights Recent Commercial Progress Product sales for Libmeldy totaled $5.1M for the first two commercial patients treated in Q1 2022 Libmeldy? access and reimbursement expanding with agreements now signed in three major European markets recognizing its clinical value OTL-200 U.S. BLA filing for MLD on track for l |
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| May 12, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| April 27, 2022 |
Orchard Therapeutics plc 108 Cannon Street London EC4N 6EU United Kingdom Orchard Therapeutics plc 108 Cannon Street London EC4N 6EU United Kingdom April 27, 2022 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| April 27, 2022 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 8, 2022 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 4, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| March 30, 2022 |
As filed with the Securities and Exchange Commission on March 30, 2022 Table of Contents As filed with the Securities and Exchange Commission on March 30, 2022 Registration Statement No. |
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| March 30, 2022 |
EX-FILING FEES 7 d280487dexfilingfees.htm EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Orchard Therapeutics plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(2) Proposed Maximum Offering Price Per Unit(3) Maxi |
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| March 30, 2022 |
Exhibit 21.1 Subsidiaries Name of Subsidiary Jurisdiction of Incorporation or Organization Orchard Therapeutics (Europe) Limited England and Wales Orchard Therapeutics North America California (United States) Orchard Therapeutics (Netherlands) B.V. Netherlands Orchard Therapeutics (France) SAS France Orchard Therapeutics (Italy) S.r.l Italy Orchard Therapeutics (Germany) GmbH Germany Orchard Thera |
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| March 30, 2022 |
Form of Senior Debt Security (included in Exhibit 4.3 hereto) Exhibit 4.3 ORCHARD THERAPEUTICS PLC TO Trustee Indenture Dated as of , 20 Senior Debt Securities TABLE OF CONTENTS Page ARTICLE ONE?DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 SECTION 101. Definitions 1 SECTION 102. Compliance Certificates and Opinions 10 SECTION 103. Form of Documents Delivered to Trustee 11 SECTION 104. Acts of Holders 11 SECTION 105. Notices, etc., to Trustee and |
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| March 30, 2022 |
Exhibit 10.19 March 30, 2022 Frank Thomas Re: First Amendment to the Transitional Services Agreement Dear Frank: As we have discussed, this First Amendment to the Transitional Services Agreement (the ?Amendment?) confirms the agreement between you, Orchard Therapeutics plc (the ?Parent?) and Orchard Therapeutics North America (the ?U.S. Subsidiary?, and together with the Parent, the ?Company?), to |
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| March 30, 2022 |
As filed with the Securities and Exchange Commission on March 30, 2022 Table of Contents As filed with the Securities and Exchange Commission on March 30, 2022 Registration Statement No. |
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| March 30, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38722 ORCHARD THERAPE |
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| March 30, 2022 |
EX-99.1 2 ortx-ex9917.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Extends Runway into 2024, Focusing HSC Gene Therapy Platform Exclusively on Severe Neurometabolic Diseases and Research Platform Libmeldy European launch momentum building with multiple MLD patients treated and strong recognition of value proposition; U.S. BLA filing of OTL-200 on track for late 2022 / early 2023 Broad research pl |
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| March 30, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Orchard Therapeutics plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial effective date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity(1) Ordinary Shares, nominal value ?0. |
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| March 30, 2022 |
Form of Subordinated Debt Security (included in Exhibit 4.5 hereto) Exhibit 4.5 ORCHARD THERAPEUTICS PLC TO Trustee Indenture Dated as of , 20 Subordinated Debt Securities TABLE OF CONTENTS Page ARTICLE ONE - DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 SECTION 101. Definitions 1 SECTION 102. Compliance Certificates and Opinions 11 SECTION 103. Form of Documents Delivered to Trustee 12 SECTION 104. Acts of Holders 13 SECTION 105. Notices, etc., to Tru |
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| March 30, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 30, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| February 14, 2022 |
ORTX / Orchard Therapeutics plc / FEDERATED HERMES, INC. Passive Investment OMB APPROVAL OMB Number: 3235-0145 Estimated average burden hours per response ?.11 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. *) ORCHARD THERAPEUTICS, PLC (Name of Issuer) COMMON STOCK (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of t |
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| February 14, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 4)* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, par value ?0.10 (represented by American Depositary Shares) (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Che |
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| February 11, 2022 |
ORTX / Orchard Therapeutics plc / CHI Advisors LLC - CHI ADVISORS LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Orchard Therapeutics plc (Name of Issuer) Ordinary Shares, nominal value 0.10 per share (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2021 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuan |
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| February 11, 2022 |
ORTX / Orchard Therapeutics plc / Flynn James E Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. |
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| February 4, 2022 |
Exhibit 99.1 Orchard Therapeutics Announces Historic Agreement Making Libmeldy? Available by NHS England for MLD Patients First-ever lentiviral hematopoietic stem cell gene therapy approved for reimbursement by NHS England Two children with early-onset MLD recently treated commercially with Libmeldy in Germany and France A third eligible patient identified through partnership in Middle East and re |
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| February 4, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 3, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 21, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 21, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 21, 2022 |
Exhibit 99.1 Orchard Therapeutics Announces Publication in The Lancet of Long-term Clinical Outcomes with Libmeldy for the Treatment of Children with Early-onset MLD Administration of one-time hematopoietic stem cell (HSC) gene therapy resulted in sustained, clinically meaningful benefits by preserving cognitive function and motor development in most patients 90% overall survival with up to 7.5 ye |
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| January 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 10, 2022 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 10, 2022 |
Exhibit 99.1 Orchard Therapeutics Announces Recent Commercial and Regulatory Progress for Late-stage HSC Gene Therapy Programs and Outlines Key 2022 Milestones Launch Momentum Building for Libmeldy? in Europe with Health Technology Assessments Progressing Favorably and Treatment Underway for Multiple Commercial Patients Initiating U.S. BLA Submission for OTL-200 as Early as Year End 2022; Construc |
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| January 10, 2022 |
Bobby Gaspar, M.D., Ph.D., chief executive officer 40th Annual J.P. Morgan Healthcare Conference January 13, 2022 Reaching New Heights, Looking to New Horizons Exhibit 99.2 2 | 40th Annual J.P. Morgan Healthcare Conference Photo courtesy of Great Ormond Street Hospital From Clinician to CEO: The Evolution of HSC Gene Therapy We aspire to end the devastation caused by genetic and other severe disea |
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| November 18, 2021 |
Exhibit 99.1 Orchard Therapeutics Announces New England Journal of Medicine Publication of Interim Proof-of-concept Study Results of OTL-203 for Hurler Syndrome 100 percent overall survival with median follow-up of two years post-treatment with HSC gene therapy Preliminary findings show promising metabolic and early clinical outcomes Results warrant further evaluation in global registrational stud |
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| November 18, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 18, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 4, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| November 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| November 4, 2021 |
Exhibit 10.1 November 3, 2021 Frank Thomas Re:Transitional Services Agreement Dear Frank: This letter confirms that you have resigned without Good Reason your employment with Orchard Therapeutics plc (the ?Parent?) and Orchard Therapeutics North America (the ?U.S. Subsidiary?, and together with the Parent, the ?Company?), and that the Company has accepted such resignation, with a mutually agreeabl |
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| November 4, 2021 |
Exhibit 99.1 Orchard Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Business Updates Updates from OTL-201 Clinical Proof-of-Concept Study in MPS-IIIA and OTL-204 Preclinical Study for GRN-FTD at ESGCT Showcase Potential for HSC Gene Therapy in Multiple Neurodegenerative Disorders Launch Activities for Libmeldy? Across Key European Countries, including Reimbursement |
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| September 14, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 9, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| September 14, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 14, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorpora |
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| September 14, 2021 |
Exhibit 99.1 Orchard Therapeutics Bolsters R&D and Technical Operations Leadership with New Executive Appointments Gene therapy experts Fulvio Mavilio, Ph.D., and Nicoletta Loggia, Ph.D., join as chief scientific officer and chief technical officer, respectively Neuroscience and rare disease leader Leslie Meltzer, Ph.D., promoted to chief medical officer Appointments reinforce company?s strategic |
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| September 14, 2021 |
Exhibit 99.1 Orchard Therapeutics Outlines Differentiated Profile of Its HSC Gene Therapy Approach and Discusses Potential Future Applications at Virtual R&D Investor Event Novel Discovery Research in HSC-generated Antigen-specific Regulatory T Cells Disclosed HSC Gene Therapy Also Provides Advantages for Delivery of Monoclonal Antibodies New Applications Present Opportunities for Future Partnersh |
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| August 4, 2021 |
As filed with the Securities and Exchange Commission on August 4, 2021 As filed with the Securities and Exchange Commission on August 4, 2021 Registration No. |
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| August 4, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 4, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| August 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| August 4, 2021 |
EXHIBIT 10.1 CERTAIN CONFIDENTIAL INFORMATION MARKED BY [***] HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Originally dated 24 May 2019 as amended and restated on the First Effective Date (as defined below) Orchard Therapeutics plc as the Company - and - The entities listed as Original Guarantors - and - |
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| August 4, 2021 |
Exhibit 99.1 Orchard Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Business Updates Regulatory feedback obtained on OTL-200 (MLD) and OTL-203 (MPS-IH) programs New HAE collaboration with Pharming Group highlights broad potential for HSC gene therapy Multiple presentations from neurometabolic programs at MPS Symposia including additional follow-up in MPS-IH Cash a |
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| July 1, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 1, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| July 1, 2021 |
Exhibit 99.1 Orchard Therapeutics and Pharming Group Announce Collaboration to Develop and Commercialize ex vivo autologous HSC Gene Therapy for Hereditary Angioedema Highlights the broader potential of Orchard?s ex vivo HSC gene therapy platform approach in new and larger indications Reinforces Pharming?s commitment to the HAE community and utilizes its relevant clinical expertise and global comm |
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| June 29, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 29, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| June 29, 2021 |
EXHIBIT 99.1 Orchard Therapeutics Announces Regulatory and Clinical Updates for Lead Gene Therapy Programs Expected clinical package for OTL-200 BLA for MLD using data from existing patients clarified with FDA Guidance obtained on design of OTL-203 global registrational trial for MPS-IH Enrollment goal met in OTL-201 POC trial for MPS-IIIA Updates for OTL-103 MAA and BLA submission timelines for W |
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| June 22, 2021 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 16, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| June 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 28, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 28, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 28, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 13, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 13, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| May 13, 2021 |
EX-99.1 2 ortx-ex99115.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Reports First Quarter 2021 Financial Results and Provides Recent Business Updates Commercial Activities Advancing for Upcoming Launch of LibmeldyTM (atidarsagene autotemcel) for Eligible Patients with Early-onset MLD in Germany Update on OTL-200 U.S. BLA Filing Strategy for MLD on Track for Mid-2021 Following Type B RMAT Meeting |
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| May 11, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 11, 2021 |
EX-99.1 2 ortx-ex9918.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Announces New England Journal of Medicine Publication of HSC Gene Therapy Data for ADA-SCID 100% overall survival and ≥95% event-free survival observed at two and three years following one-time treatment with lentiviral HSC gene therapy 50 total participants represent largest published dataset of gene therapy-treated patients with |
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| April 28, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 14, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 8, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| April 14, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 8, 2021 |
Table of Contents As filed with the Securities and Exchange Commission on April 8, 2021 Registration No. |
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| March 2, 2021 |
EX-21.1 2 ortx-ex2116.htm EX-21.1 Exhibit 21.1 Subsidiaries Name of Subsidiary Jurisdiction of Incorporation or Organization Orchard Therapeutics (Europe) Limited England and Wales Orchard Therapeutics North America California (United States) Orchard Therapeutics (Netherlands) B.V. Netherlands Orchard Therapeutics (France) SAS France Orchard Therapeutics (Italy) S.r.l Italy Orchard Therapeutics (G |
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| March 2, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 2, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| March 2, 2021 |
EX-99.1 2 ortx-ex9916.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Reports 2020 Financial Results and Reviews Recent Accomplishments $150M Strategic Financing Supports Execution into the First Half of 2023 OTL-203 Achieves Proof of Concept (POC) in MPS-I Hurler Syndrome (MPS-IH); Registrational Trial Planned to Initiate by Year End 2021 OTL-200 U.S. Filing Strategy for Metachromatic Leukodystroph |
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| March 2, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38722 ORCHARD THERAPE |
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| February 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3)* ORCHARD THERAPEUTICS PLC (Name of Issuer) Ordinary Shares, par value £0.10 (represented by American Depositary Shares) (Title of Class of Securities) 68570P101 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check |
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| February 12, 2021 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. |
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| February 9, 2021 |
EX-10.1 2 d100234dex101.htm EX-10.1 Exhibit 10.1 Execution Version SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of February 4, 2021 (the “Effective Date”), among Orchard Therapeutics plc, a public limited company incorporated under the laws of England and Wales (the “Company”), and each purchaser identified on Exhibit A attached hereto (each a “Pu |
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| February 9, 2021 |
EX-99.1 3 d100234dex991.htm EX-99.1 Exhibit 99.1 Orchard Therapeutics Announces $150 Million Strategic Financing Strengthened Financial Position Supports Execution into the First Half of 2023 BOSTON and LONDON, February 5, 2021 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that it has executed a securities purchase agreement to raise gross proceeds of $150 mi |
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| February 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 4, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| February 9, 2021 |
EX-99.2 4 d100234dex992.htm EX-99.2 Exhibit 99.2 Orchard Therapeutics Announces Interim Data for OTL-203 Showing Positive Clinical Results in Multiple Disease Manifestations of Mucopolysaccharidosis Type I Hurler Syndrome (MPS-IH) All eight patients treated with OTL-203 show stable cognitive function, motor function and growth within the normal range at multiple data points post-treatment Supporti |
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| January 29, 2021 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 29, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 29, 2021 |
Exhibit 99.1 Orchard Therapeutics Appoints Braden Parker as Chief Commercial Officer Commercial Launch of Libmeldy™ in Europe On-Track for 1H 2021 BOSTON and LONDON, Jan. 29, 2021 - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the appointment of Braden Parker to the role of Chief Commercial Officer (CCO). In this capacity, Mr. Parker will oversee all aspects o |
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| January 19, 2021 |
Exhibit 99.1 Orchard Therapeutics Secures Partnerships to Broaden Access to LibmeldyTM for Eligible Patients in Middle East & Turkey BOSTON and LONDON, Jan. 19, 2021 (GLOBE NEWSWIRE) - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced plans to extend the company’s commercial reach in the Middle East and Turkey through exclusive agreements with GenPharm Services and |
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| January 19, 2021 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 19, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 14, 2021 |
Exhibit 99.1 Orchard Therapeutics Announces OTL-200 Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by FDA for the Treatment of Metachromatic Leukodystrophy (MLD) Interactions with FDA anticipated by mid-2021 to determine the BLA filing strategy for OTL-200 BOSTON and LONDON, January 14, 2021 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced tha |
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| January 14, 2021 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 14, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 11, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2021 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| January 11, 2021 |
Exhibit 99.1 Orchard Therapeutics Announces 2021 Corporate Priorities Supporting the Build-out of its Commercial Business in Hematopoietic Stem Cell (HSC) Gene Therapy and Expansion of its Clinical Applications Preparations on Track for First Half 2021 Commercial Launch of Libmeldy™ (OTL-200), the First Approved Product for Metachromatic Leukodystrophy (MLD) in the EU Filing Strategy for OTL-200 B |
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| January 11, 2021 |
2021 JP Morgan Presentation Bobby Gaspar, M.D., Ph.D. Chief executive officer January 13, 2021 Exhibit 99.2 Certain information set forth in this presentation and in statements made orally during this presentation contains “forward-looking statements”. Except for statements of historical fact, information contained herein constitutes forward-looking statements and may include, but is not limited t |
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| December 21, 2020 |
Exhibit 99.1 Orchard Therapeutics Receives EC Approval for Libmeldy™ for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD) • First gene therapy to receive full EU marketing authorization for eligible MLD patients • One-time treatment with Libmeldy has been shown to preserve motor and cognitive function • Achievement shared with research alliance partners Fondazione Telethon and Osped |
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| December 21, 2020 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 21, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| December 8, 2020 |
Financial Statements and Exhibits - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 8, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| December 8, 2020 |
Exhibit 99.1 Orchard Therapeutics Reports OTL-201 Initial Clinical Data in Sanfilippo Syndrome Type A (MPS-IIIA) Preliminary results from first patient treated with OTL-201 show over expression of the therapeutic enzyme and decrease in substrate levels three months following gene therapy BOSTON and LONDON, December 8, 2020 - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, yester |
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| November 19, 2020 |
Financial Statements and Exhibits - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 19, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 19, 2020 |
Exhibit 99.1 Orchard Therapeutics Announces FDA Clearance of IND Application for OTL-200 for Metachromatic Leukodystrophy (MLD) BOSTON and LONDON, November 19, 2020 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OTL-200, an autologous, hema |
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| November 12, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| November 12, 2020 |
Exhibit 99.1 Orchard Therapeutics Unveils Details on New HSC Gene Therapy Research Programs as Part of R&D Investor Event Tomorrow at 9:00 a.m. ET First look at preclinical data in frontotemporal dementia with progranulin mutations (GRN-FTD) and new amyotrophic lateral sclerosis (ALS) program NOD2 mutation revealed as Crohn’s disease (CD) genetic target, associated with 7-10% of all CD cases in th |
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| November 5, 2020 |
Financial Statements and Exhibits - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 5, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| November 5, 2020 |
Exhibit 99.1 Orchard Therapeutics Announces New OTL-201 Clinical Data in Sanfilippo Syndrome Type A (MPS-IIIA) Accepted for Oral Presentation at 62nd American Society of Hematology Annual Meeting Preliminary results from first patient in ongoing proof-of-concept trial show evidence of engraftment of gene-modified cells three months following treatment BOSTON and LONDON, November 5, 2020 - Orchard |
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| November 3, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| November 3, 2020 |
Exhibit 99.1 Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results Libmeldy TM Receives Positive CHMP Opinion for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD); U.S. IND Application on Track for Year End 2020 Cash and Investments of More Than $200M and Runway into 2022 Frontotemporal dementia (FTD) and Crohn’s Disease Preclinical |
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| November 3, 2020 |
Financial Statements and Exhibits - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| October 30, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| October 16, 2020 |
Financial Statements and Exhibits - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 16, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporati |
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| October 16, 2020 |
Exhibit 99.1 Orchard Therapeutics Receives Positive CHMP Opinion for LibmeldyTM for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD) First therapy recommended for full marketing authorization in the EU for eligible patients with confirmed diagnosis of late infantile or early juvenile MLD variants One-time treatment with Libmeldy has been shown to preserve cognitive and motor functio |
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| September 28, 2020 |
Orchard Therapeutics Receives EMA PRIME Designation for OTL-203 for the Treatment of MPS-I Exhibit 99.1 Orchard Therapeutics Receives EMA PRIME Designation for OTL-203 for the Treatment of MPS-I BOSTON and LONDON, September 28, 2020 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to OTL-203, an investigational ex vivo autologous hematopoietic stem cell (HSC) g |
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| September 28, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 28, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorpora |
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| September 1, 2020 |
Exhibit 99.1 Orchard Therapeutics Announces Additional Interim Results from Proof-of-Concept Study of OTL-203 for MPS-I Data on all eight patients demonstrate sustained engraftment and supranormal IDUA enzyme expression Translation of metabolic correction to clinical outcomes in first two patients continues to support potential of hematopoietic stem cell gene therapy in a second neurometabolic dis |
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| September 1, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 1, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporat |
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| August 6, 2020 |
S-8 As filed with the Securities and Exchange Commission on August 6, 2020 Registration No. |
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| August 6, 2020 |
Exhibit 99.1 Orchard Therapeutics Advances New Strategic Plan and Reports Second Quarter 2020 Financial Results Regulatory and Clinical Progress in MLD, MPS-I and MPS-IIIA Illustrate Execution in Neurometabolic Disorders; EU Regulatory Decision for Libmeldy™ Expected in 2H 2020 MolMed and GSK Agreements Provide Near-term Manufacturing Capacity and Highlight Future Innovations Near-term Financial P |
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| August 6, 2020 |
2020 Inducement Equity Plan and forms of award agreements thereunder EX-99.2 Exhibit 99.2 ORCHARD THERAPEUTICS PLC 2020 INDUCEMENT EQUITY PLAN SECTION 1. GENERAL PURPOSE OF THE PLAN; DEFINITIONS The name of the plan is the Orchard Therapeutics plc 2020 Inducement Equity Plan (the “Plan”). The purpose of the Plan is to enable Orchard Therapeutics plc (the “Company”) and its Affiliates to grant equity awards to induce highly-qualified prospective officers and employe |
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| August 6, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 6, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| August 6, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| August 6, 2020 |
CERTAIN IDENTIFIED INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY “[***]”, HAS BEEN EXCLUDED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. |
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| July 20, 2020 |
Exhibit 99.1 Orchard Therapeutics Announces Orphan Drug and Rare Pediatric Disease Designations for OTL-203 for the Treatment of MPS-I BOSTON and LONDON, July 20, 2020 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company has received both orphan drug designation and rare pediatric disease designation from the U.S Food and Drug Administration (FDA) f |
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| July 20, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 20, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| July 15, 2020 |
Orchard Therapeutics Announces Global License Agreements for Stable Cell Line Technology from GSK Exhibit 99.1 Orchard Therapeutics Announces Global License Agreements for Stable Cell Line Technology from GSK BOSTON and LONDON, July 15, 2020 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company has entered into two worldwide royalty-bearing license agreements with GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) for use of their proprietary lentiviral s |
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| July 15, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 15, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| July 9, 2020 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 2, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| July 9, 2020 |
Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration Exhibit 99.1 Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration BOSTON and LONDON and MILAN, Italy, July 9, 2020 – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and MolMed S.p.A (MLMD.MI), one of the company’s principal contract development and manufacturing partners, today announced that they have extended their collaboration – init |
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| June 19, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 17, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| June 19, 2020 |
Articles of Association of Orchard Therapeutics plc Exhibit 3.1 DATED 17 JUNE 2020 The Companies Act 2006 Public Company Limited by shares ARTICLES OF ASSOCIATION of ORCHARD THERAPEUTICS PLC ACTIVE/102506167.3 TABLE OF CONTENTS 1Defined terms1 2Interpretation1 3Form of Resolution3 4Capital3 5Limited Liability3 6Change of Name4 7Power to Attach Rights to Shares4 8Allotment of Shares and Pre-Emption4 9Redeemable Shares5 10Shareholder Rights5 11Pari P |
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| May 15, 2020 |
Exhibit 99.1 Orchard Therapeutics Presents New Interim Data from OTL-203 Proof-of-concept Study for MPS-I First Primary Outcome Measure Met with All Eight Patients Achieving Hematologic Engraftment Improved Motor Skills, Stable Cognitive Scores and Normal Growth Seen in First Two Patients One-year Follow-up Results and Initiation of Registrational Trial Expected in 2021 BOSTON and LONDON, May 15, |
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| May 15, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) |
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| May 7, 2020 |
2019 Short-Term Incentive Plan Exhibit 10.1 Orchard Therapeutics plc 2019 Short-Term Incentive Plan Contents Article 1. Establishment, Objectives, and Duration 2 Article 2. Definitions 2 Article 3. Administration 4 Article 4. Eligibility and Participation 4 Article 5. Short-Term Cash-Based Awards 5 Article 6. Performance Measures 7 Article 7. Rights of Employees 8 Article 8. Amendment, Modification, and Termination 8 Article 9. |
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| May 7, 2020 |
Exhibit 10.3 Amendment Letter 7 April 2020 From (1) Orchard Therapeutics plc, a company incorporated in England and Wales with company number 11494381 for itself and as Obligors' Agent for and on behalf of the Obligors (the "Company") To (2) Midcap Financial (Ireland) Limited as agent of the other Finance Parties (the "Agent") Recitals: (A) We refer to the senior term facilities agreement dated 24 |
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| May 7, 2020 |
CERTAIN IDENTIFIED INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY “[***]”, HAS BEEN EXCLUDED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. |
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| May 7, 2020 |
Exhibit 99.1 Orchard Therapeutics Unveils New Strategic Plan and Reports First Quarter 2020 Financial Results Portfolio Investments More Tightly Prioritized Around High Need, High Value Indications First Disease Targets Extending Platform into Less Rare Indications Disclosed Updated Timelines Provided for MLD and MPS-I Programs California Facility Investment Terminated with Near-term Manufacturing |
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| May 7, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38722 ORCHARD THERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) England and Wales Not Applicable ( State or other jurisdiction of incorporation or organization) (I. |
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| May 7, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation) ( |
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| April 29, 2020 |
DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 27, 2020 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 27, 2020 ORCHARD THERAPEUTICS PLC (Exact name of Registrant as Specified in Its Charter) England and Wales 001-38722 Not Applicable (State or Other Jurisdiction of Incorporation |
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| April 27, 2020 |
Exhibit 99.1 Orchard Therapeutics Announces First Patient Dosed with OTL-201 Gene Therapy in Proof-of-Concept Clinical Trial for Sanfilippo Syndrome (MPS-IIIA) BOSTON and LONDON, April 27, 2020 (GLOBE NEWSWIRE) - Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the first patient has been dosed in an open-label, proof-of-concept investigational study of OTL-20 |
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| April 14, 2020 |
ORTX / Orchard Therapeutics plc PRE 14A - - PRE 14A PRE 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
