Basic Stats
CIK | 1826492 |
SEC Filings
SEC Filings (Chronological Order)
March 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 15 CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER SECTION 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR SUSPENSION OF DUTY TO FILE REPORTS UNDER SECTIONS 13 AND 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. Commission File Number 001-39838 GRACELL BIOTECHNOLOGIES INC. (Exact name of registrant as specifie |
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February 26, 2024 |
As filed with the Securities and Exchange Commission on February 26, 2024 As filed with the Securities and Exchange Commission on February 26, 2024 Registration No. |
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February 26, 2024 |
As filed with the Securities and Exchange Commission on February 26, 2024 As filed with the Securities and Exchange Commission on February 26, 2024 Registration No. |
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February 26, 2024 |
As filed with the Securities and Exchange Commission on February 26, 2024 As filed with the Securities and Exchange Commission on February 26, 2024 Registration No. |
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February 26, 2024 |
As filed with the Securities and Exchange Commission on February 26, 2024 As filed with the Securities and Exchange Commission on February 26, 2024 Registration No. |
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February 22, 2024 |
Gracell Biotechnologies Acquisition Completed Exhibit 99.1 Gracell Biotechnologies Acquisition Completed SAN DIEGO and SUZHOU, China and SHANGHAI, China, February 22, 2024 - Gracell Biotechnologies Inc. (“Gracell” or the “Company”, Nasdaq: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune disease, today announced the completion of its previously announced a |
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February 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2024 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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February 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2024 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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February 20, 2024 |
Gracell Biotechnologies Announces Shareholders’ Approval of Merger Agreement Exhibit 99.1 Gracell Biotechnologies Announces Shareholders’ Approval of Merger Agreement SAN DIEGO and SUZHOU, China and SHANGHAI, China, Feb. 20, 2024 - Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseas |
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February 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* GRACELL BIOTECHNOLOGIES INC. (Name of Issuer) Ordinary Shares, par value $0.0001 per share American Depository Shares, each of which represents five Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) |
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February 14, 2024 |
EX-1 2 tm246065d12ex1.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 Commission a |
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February 14, 2024 |
SC 13G 1 g118245sc13g.htm CUSIP No. 38406L103 Page 1 of 6 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103 ** (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this St |
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February 14, 2024 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 Under the Securities Exchange Act of 1934 (Amendment No. 2)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary shares, par value $0.0001 per share (Title of Class of Sec |
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February 14, 2024 |
EX-99.1 2 tm246211d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k) promulgated under the Securities Exchange Act of 1934, as amended, the undersigned hereby agree to the joint filing with all other Reporting Persons (as such term is defined in the Schedule 13G referred to below) on behalf of each of them of a statement on Schedule 13G (including amendm |
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February 13, 2024 |
SC 13G/A 1 ea193538-13ga1vivogracell.htm AMENDMENT NO. 1 TO SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share, represented by American Depositary Shares (Title of Class of Securities) 38406L103 (CUS |
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February 13, 2024 |
SC 13G/A 1 ea193272-13ga1lavbio5grace.htm AMENDMENT NO. 1 TO SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) December 31, 2023 (Date of Event |
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February 13, 2024 |
EX-99.1 2 ea193272ex99-1grace.htm AGREEMENT OF JOINT FILING Exhibit 99.1 AGREEMENT OF JOINT FILING The undersigned hereby agree that a single Schedule 13G (or any amendment thereto) relating to the Common Stock of Gracell Biotechnologies Inc. shall be filed on behalf of each of the undersigned and that this Agreement shall be filed as an exhibit to such Schedule 13G. Dated: February 13, 2024 LAV g |
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January 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of January 2024 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republ |
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January 30, 2024 |
Exhibit 99.1 Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1 Clinical Trial of FasTCAR-T GC012F as Early-Line Treatment of Multiple Myeloma Further expands clinical development of FasTCAR-T GC012F in multiple myeloma amid ongoing U.S. trial evaluating therapy for treatment of relapsed/refractory multiple myeloma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Jan. 2 |
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January 17, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of January 2024 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republ |
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January 17, 2024 |
TABLE OF CONTENTS Exhibit 99.1 Gracell Biotechnologies Inc. Building 12, 218 Sangtian St. Suzhou BioBay Park, Suzhou, 215000 People’s Republic of China January 17, 2024 Dear Gracell Shareholders: You are cordially invited to attend an extraordinary general meeting (the “Extraordinary General Meeting”) of shareholders of Gracell Biotechnologies Inc. (“Gracell,” the “Company,” “we,” “our” or “us”), |
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January 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of January 2024 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republ |
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January 2, 2024 |
Investor Frequently Asked Questions (FAQ) Exhibit 99.1 Investor Frequently Asked Questions (FAQ) 1. When did discussions between AstraZeneca and Gracell begin? How long did this process take? We intend to furnish a proxy statement (the “Proxy Statement”) with the US Securities and Exchange Commission (the “SEC”) on Form 6-K. Please refer to our Proxy Statement when it becomes available for details of the history of discussions between the |
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January 2, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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December 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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December 26, 2023 |
Frequently Asked Questions (FAQ) Exhibit 99.4 Frequently Asked Questions (FAQ) Benefits of Our Combination 1. What is the benefit of this acquisition for Gracell and AstraZeneca, and why was it the best path forward? By combining the expertise and resources at AstraZeneca and Gracell, we can unlock new ways to harness Gracell’s FasTCAR manufacturing platform, which we believe has the potential to optimize the therapeutic profile |
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December 26, 2023 |
Exhibit 99.2 Gracell Biotechnologies to be acquired by AstraZeneca, furthering cell therapy ambition across oncology and autoimmune diseases Proposed acquisition will enrich the AstraZeneca cell therapy pipeline with clinical-stage autologous BCMA/CD19 CAR-T therapy targeting haematologic malignancies and autoimmune diseases, and proprietary cell therapy manufacturing platform Gracell shareholders |
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December 26, 2023 |
Exhibit 2.1 Execution Version AGREEMENT AND PLAN OF MERGER by and among ASTRAZENECA TREASURY LIMITED, GREY WOLF MERGER SUB and GRACELL BIOTECHNOLOGIES INC. Dated as of December 23, 2023 TABLE OF CONTENTS Page Article I THE MERGER 2 Section 1.1 The Merger 2 Section 1.2 Closing 2 Section 1.3 Effective Time 3 Section 1.4 Effect of the Merg |
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December 26, 2023 |
Exhibit 99.3 LETTER TO COMPANY EMPLOYEES Dear Gracell Team: Today is a significant day for Gracell Biotechnologies Inc. A few minutes ago, we announced that our company has entered into a definitive agreement with AstraZeneca, pursuant to which, AstraZeneca will acquire all of our company’s outstanding shares for a price of $2.00 per ordinary share in cash ($10.00 per ADS), plus a non-tradable con |
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December 26, 2023 |
Exhibit 99.1 VOTING AND SUPPORT AGREEMENT THIS VOTING AND SUPPORT AGREEMENT (this “Agreement”) is made and entered into as of December 23, 2023, by and between AstraZeneca Treasury Limited, a private limited company incorporated under the laws of England and Wales (“Parent”), and the undersigned holder (the “Shareholder”) of ordinary shares of Gracell Biotechnologies Inc., an exempted compan |
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December 22, 2023 |
Exhibit 99.1 Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus Expands clinical development of GC012F in rSLE following FDA IND clearance for Phase 1/2 trial in the United States Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aim |
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December 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Rep |
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December 18, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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December 18, 2023 |
Exhibit 99.1 Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023 Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR- |
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November 14, 2023 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Third Quarter 2023 Unaudited Financial Results and Provides Corporate Update · Dosed first patient in Phase 1b/2 clinical trial in the US evaluating FasTCAR-T GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) · Expect to commence Phase 1/2 clinical trial in China evaluating GC012F for the treatment of RRMM in the four |
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November 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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October 19, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value US$0.0001 per share (Title of Class of Securities) 38406L103 (CUSIP Number) October 17, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to des |
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September 29, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of September 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repu |
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September 29, 2023 |
Exhibit 99.1 Gracell Biotechnologies Reports Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent Complete Response Rate - Updated results from the BCMA/CD19 dual-targeted GC012F, including longer-term follow-up and three additional patients, presented at the International Myeloma Society Annual Meeting - 100% (19/19) patients ach |
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September 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of September 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repu |
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September 27, 2023 |
Exhibit 99.1 Gracell Biotechnologies Doses First Patient in Phase 1b/2 Clinical Trial in U.S. Evaluating GC012F for Treatment of Relapsed/Refractory Multiple Myeloma SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, September 26, 2023 - Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and |
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September 21, 2023 |
September 21, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Daniel Crawford Mr. Jason Drory Re: Gracell Biotechnologies Inc. Registration Statement on Form F-3 (File No. 333-274191) Ladies and Gentlemen: Pursuant to Rule 461 of Regulation C (“Rule 461”) promulgated under the Securit |
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September 12, 2023 |
Will H. Cai +852 3758 1210 [email protected] September 12, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Daniel Crawford Mr. Jason Drory Re: Gracell Biotechnologies Inc. Registration Statement on Form F-3 Filed August 24, 2023 File No. 333-274191 Ladies and Gentlemen: On behalf of our |
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September 12, 2023 |
As filed with the Securities and Exchange Commission on September 12, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 12, 2023 Registration No. |
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September 6, 2023 |
Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China September 6, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Disclosure Review Program 100 F Street, N.E. Washington, D.C. 20549 Attn: Austin Pattan Andrew Mew Re: Gracell Biotechnologies Inc. (the “Comp |
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August 24, 2023 |
Exhibit 107 CALCULATION OF FILING FEE TABLE FORM F-3 (Form Type) GRACELL BIOTECHNOLOGIES INC. |
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August 24, 2023 |
As filed with the Securities and Exchange Commission on August 24, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 24, 2023 Registration No. |
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August 21, 2023 |
GRCL / Gracell Biotechnologies Inc - 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. )* GRACELL BIOTECHNOLOGIES INC. (Name of Issuer) Ordinary Shares, par value $0.0001 per share American Depository Shares, each of which represents five Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) Aug |
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August 18, 2023 |
SC 13G 1 ea183893-13gvivogracell.htm SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share, represented by American Depositary Shares (Title of Class of Securities) 38406L103 (CUSIP Number) August 10, 2023 |
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August 18, 2023 |
EX-99.1 2 ea183893ex99-1gracell.htm JOINT FILING STATEMENT EXHIBIT 99.1 Joint Filing Agreement The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing additional joint filing |
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August 14, 2023 |
Exhibit 99.2 RECENT DEVELOPMENT Unless otherwise stated or unless the context otherwise requires, the terms, “we,” “us,” “our,” “our Company,” “Gracell” refer to Gracell Biotechnologies Inc. Results of Operations for the Six Months Ended June 30, 2023 Set forth below is a discussion of our unaudited statements of comprehensive loss data for the six months ended June 30, 2022 and 2023. In the below |
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August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republi |
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August 14, 2023 |
Table of Contents Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. INDEX TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Unaudited Interim Condensed Consolidated Financial Statements PAGES Unaudited Interim Condensed Consolidated Balance Sheets as of December 31, 2022 and June 30, 2023 F-2 Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the Six Months En |
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August 11, 2023 |
Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that Amendment No. 1 to the Statement on Schedule 13D, dated August 10, 2023, with respect to the ordinary shares and American depository shares of Gracell Biotechnologies Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended. Each o |
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August 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 1)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share American Depository Shares, each of which represents five Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) Or |
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August 7, 2023 |
Exhibit 10.1 Execution Version SUBSCRIPTION AGREEMENT This Subscription Agreement (this “Agreement”) is made as of August 7, 2023 by and among: (1) Gracell Biotechnologies Inc., an exempted company with limited liability incorporated in the Cayman Islands (the “Company”); and (2) each of the purchasers listed on Schedule I hereto (together the “Purchasers,” and each, a “Purchaser”). The Company an |
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August 7, 2023 |
Exhibit 99.1 Gracell Biotechnologies Announces Up to $150 Million Private Placement Financing Joined by a Syndicate of Premier Healthcare Investors · Oversubscribed transaction led by Vivo Capital and joined by leading healthcare investors including Adage Capital Partners LP, Exome Asset Management, Janus Henderson Investors, Logos Capital, OrbiMed, Pivotal Life Sciences, RA Capital Management and |
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August 7, 2023 |
Exhibit 99.2 UNVEILING NEXT GEN CAR-T CELL THERAPIES CORPORATE PRESENTATION AUGUST 2023 NASDAQ: GRCL GRACELLBIO.COM 2 DISCLAIMER This presentation has been prepared by Gracell Biotechnologies Inc. (the “Company”) solely for information purpose on a confidential basis and has not been independently verified. By viewing or accessing the information contained in this presentation, the recipient hereb |
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August 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republi |
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July 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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July 14, 2023 |
Exhibit 3.1 AMENDMENT TO FOURTH AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION OF GRACELL BIOTECHNOLOGIES INC. (adopted by a Special Resolution passed and effective on July 13, 2023) The first sentence in paragraph 7 of the Fourth Amended and Restated Memorandum of Association of Gracell Biotechnologies Inc. shall be replaced with the following in its entirety: “The authorized share capital of the |
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June 14, 2023 |
Exhibit 99.1 Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate Data on CD19/BCMA dual-targeting FasTCAR-T GC012F showed 100% overall response rate (ORR) and 66.7% 6-month complete response (CR) rate among treated patients, all with diffuse large B-cell lymphoma (DLBCL) subtype Data on GC012 |
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June 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of June 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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June 5, 2023 |
Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on July 13, 2023 (or any adjournment(s) or postponement(s) thereof) On Thursday, July 13, 2023, Gracell Biotechnologies Inc. (the “Company”) will hold its annual general meeting (“AGM”) of shareholders at 41th Floor, Buildi |
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June 5, 2023 |
Exhibit 99.2 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) FORM OF PROXY FOR ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on July 13, 2023 (or any adjournment(s) or postponement(s) thereof) Introduction This Form of Proxy is furnished in connection with the solicitation by the Board of Directors of Gracell Biotechnologies Inc. (the “Co |
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June 5, 2023 |
Exhibit 99.3 23848 Gracell Biotechnologies VIF Proof 3 Annual General Meeting of Gracell Biotechnologies, Inc. Date: July 13, 2023 See Voting Instruction On Reverse Side. Please make your marks like this: x Use pen only • Mark, sign and date your Voting Instruction Form. • Detach your Voting Instruction Form. • Return your Voting Instruction Form in the postage-paid envelope provided. MAIL Please |
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June 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of June 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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June 5, 2023 |
Exhibit 99.1 Gracell Biotechnologies Presents Updated Data of Deep and Durable Responses for FasTCAR-T GC012F in Relapsed/Refractory Multiple Myeloma at 2023 ASCO Annual Meeting Data on BCMA/CD19 dual-targeting FasTCAR-T GC012F showed 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk relapsed/refractory multiple mye |
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June 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of June 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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May 16, 2023 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports First Quarter 2023 Unaudited Financial Results, and Provides Corporate Update · Presenting longer-term follow-up data from investigator-initiated trial (IIT) evaluating BCMA/CD19 dual-targeting FasTCAR-T GC012F in relapsed/refractory multiple myeloma (RRMM) at 2023 ASCO and EHA2023 · On track to commence a Phase 1b/2 clinical trial in U.S. |
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May 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic o |
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May 16, 2023 |
Exhibit 99.1 Gracell Biotechnologies Initiates Investigational Study Evaluating GC012F for Treatment of Refractory Systemic Lupus Erythematosus (SLE) Gracell announces start of investigator-initiated trial to expand clinical evaluation of FasTCAR-T GC012F into autoimmune disease GC012F pioneers the use of CD19/BCMA dual-targeting CAR-T in SLE, aiming for deeper and wider depletion of autoantibodie |
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May 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic o |
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April 25, 2023 |
Consent of AllBright Law Offices Exhibit 15.3 Date: April 25, 2023 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir/Madam: We hereby consent to the reference to our firm and the summary of our opinion under the headings “Item 3. Key Information,” “Item 3. Key Information—D. Risk Factors—Risks Related to Our Corpor |
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April 25, 2023 |
Exhibit 13.2 Certification by the Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of Gracell Biotechnologies Inc (the “Company”) on Form 20-F for the fiscal year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yili Kevin Xie, Chief Financial Officer of the C |
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April 25, 2023 |
License Agreement between Seagen Inc. and Gracell Biotechnologies, Inc., dated March 8, 2023. Exhibit 4.20 Certain confidential information contained in this document, marked by [***], has been omitted because such information is both not material and is the type that Gracell Biotechnologies Inc. customarily and actually treats that as private or confidential. LICENSE AGREEMENT This License Agreement (this “Agreement”), entered into by and between Seagen Inc., a Delaware corporation with o |
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April 25, 2023 |
Exhibit 13.1 Certification by the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of Gracell Biotechnologies Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, William Wei Cao, Chief Executive Officer of the |
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April 25, 2023 |
Consent of PricewaterhouseCoopers Zhong Tian LLP, an independent Registered Public Accounting Firm Exhibit 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (File No. 333-253486 and File No. 333-269505) and Form F-3 (No. 333-264545) of Gracell Biotechnologies Inc. of our report dated April 25, 2023 relating to the financial statements, which appears in this Form 20-F. /s/ PricewaterhouseCo |
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April 25, 2023 |
Exhibit 12.2 Certification by the Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Yili Kevin Xie, certify that: 1.I have reviewed this annual report on Form 20-F of Gracell Biotechnologies Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made |
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April 25, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ 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) |
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April 25, 2023 |
Exhibit 12.1 Certification by the Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, William Wei Cao, certify that: 1.I have reviewed this annual report on Form 20-F of Gracell Biotechnologies Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements mad |
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April 25, 2023 |
Consent of Harney Westwood & Riegels Exhibit 15.2 Date: April 25, 2023 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir or Madam: Gracell Biotechnologies Inc. (the Company) We are attorneys-at-law qualified to practise in the Cayman Islands and have been asked to provide this consent to you with regard to the laws of |
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April 25, 2023 |
Exhibit 15.4 VIA EDGAR April 25, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Finance 100 F Street, N.E. Washington, D.C. 20549 Re:Gracell Biotechnologies Inc. Supplemental Submission pursuant to Item 16I(a) of Form 20-F Dear Madam/Sir: This letter is being submitted to the U.S. Securities and Exchange Commission (the “Commission”) pursuant to the requirem |
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March 31, 2023 |
GRCL / Gracell Biotechnologies Inc - ADR / ORBIMED ADVISORS LLC - SCHEDULE 13D Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share American Depository Shares, each of which represents five Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) OrbiMed Advisors LLC |
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March 31, 2023 |
Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on Schedule 13D, dated March 29, 2023, with respect to the ordinary shares of Gracell Biotechnologies Inc. |
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March 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of March 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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March 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of March 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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March 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of March 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic |
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March 14, 2023 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Fourth Quarter and Full Year 2022 Unaudited Financial Results, and Provides Corporate Update · Plan to commence Phase 1b/2 clinical trial in US evaluating FasTCAR-T GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) in the second quarter of 2023 after receipt of FDA clearance for Investigational New Drug (IND) applicat |
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February 14, 2023 |
EX-99 2 ss1758576ex99a.htm JOINT FILING AGREEMENT EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on this Schedule 13G dated December 31, 2022 (the “Schedule 13G”), with respect to the Ordinary Shares, par value $0.0001 per share, of Gracell Biotechnologies Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) unde |
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February 14, 2023 |
SC 13G/A SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. |
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February 14, 2023 |
SC 13G/A 1 ss1758576sc13ga.htm UNDER THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G (Amendment No. 1)* Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value $0.0001 per share (Title of Class of Securities) 38406L103 (CUSIP Number) December 31, 2022 (Date of Event Whi |
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February 13, 2023 |
SC 13G/A 1 SEC13GFiling.htm SEC SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1 )* Gracell Biotechnologies Inc. (Name of Issuer) Common Stock (Title of Class of Securities) G4037L105 (CUSIP Number) December 30, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropria |
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February 7, 2023 |
Exhibit 99.1 Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies Company plans to initiate Phase 1b/2 clinical trial in the U.S. in s |
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February 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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February 7, 2023 |
Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k) promulgated under the Securities Exchange Act of 1934, as amended, the undersigned hereby agree to the joint filing with all other Reporting Persons (as such term is defined in the Schedule 13G referred to below) on behalf of each of them of a statement on Schedule 13G (including amendments thereto) with respect to the ordinary s |
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February 7, 2023 |
GRCL / Gracell Biotechnologies Inc. / William Cao Wei - SC 13G/A Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 Under the Securities Exchange Act of 1934 (Amendment No. 1)* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary shares, par value $0.0001 per share (Title of Class of Sec |
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February 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1 )* Gracell Biotechnologies Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 38406L103 (CUSIP Number) December 30, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to whic |
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February 1, 2023 |
As filed with the Securities and Exchange Commission on February 1, 2023 As filed with the Securities and Exchange Commission on February 1, 2023 Registration No. |
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February 1, 2023 |
EX-FILING FEES 4 tm234978d1ex-filingfees.htm EX-FILING FEES Exhibit 107 CALCULATION OF FILING FEE TABLE FORM S-8 (Form Type) GRACELL BIOTECHNOLOGIES INC. (Exact Name of Registrant as Specified in its Charter) Not Applicable (Translation of Registrant’s Name into English) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum |
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January 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of January 2023 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republ |
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January 6, 2023 |
Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China January 6, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Ibolya Ignat Franklin Wyman Re: Gracell Biotechnologies Inc. (the “Compa |
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January 6, 2023 |
Exhibit 99.1 UNVEILING NEXT GEN CAR - T CELL THERAPIES CORPORATE PRESENTATION JANUARY 2023 NASDAQ: GRCL GRACELLBIO.COM 2 DISCLAIMER This presentation has been prepared by Gracell Biotechnologies Inc. (the ?Company?) solely for information purpose and has no t b een independently verified. By viewing or accessing the information contained in this presentation, the recipient hereby acknowledges and |
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December 16, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of December 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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December 16, 2022 |
Exhibit 99.1 Gracell Biotechnologies to Present First Clinical Data of FasTCAR-T GC012F for Newly Diagnosed Multiple Myeloma at 64th American Society of Hematology Annual Meeting & Exposition BCMA/CD19 dual-targeting FasTCAR-T GC012F demonstrated 100% ORR and 100% MRD negativity in the 13 patients treated SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China (Nov. 3, 2022) – Gracell Biotechnologies Inc |
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November 16, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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November 16, 2022 |
Exhibit 99.1 Gracell Biotechnologies Wins 2022 Fierce Life Sciences Innovation Award FasTCAR next-day manufacturing autologous CAR-T platform recognized with prestigious biotech innovation award SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China (Nov. 15, 2022) – Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to de |
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November 16, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Third Quarter 2022 Unaudited Financial Results and Provides Corporate Update · On track to submit IND filings in U.S. and China for GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) in the fourth quarter 2022 · First clinical data from ongoing investigator-initiated trial (IIT) evaluating GC012F in newly-diagnosed mul |
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November 16, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Repub |
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October 18, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of October 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republ |
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October 18, 2022 |
Exhibit 99.1 Gracell Biotechnologies Doses First Patient in Phase 2 Portion of Registrational Phase 1/2 Clinical Trial Evaluating GC007g for Treatment of B-cell Acute Lymphoblastic Leukemia Clinical trial assessing allogeneic, HLA-matched, donor-derived allogeneic CAR-T therapy SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China (October 17, 2022) ? Gracell Biotechnologies Inc. (?Gracell? or the ?Com |
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September 15, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of September 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Repu |
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August 15, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Second Quarter 2022 Unaudited Financial Results and Provides Corporate Update ? Presented updated clinical data from an investigator-initiated trial (IIT) evaluating FasTCAR GC012F for the treatment of relapsed/refractory multiple myeloma (r/r MM) at ASCO and EHA 2022, which underscored the deep response with a 100% MRD negativity rate ? P |
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August 15, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republi |
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August 15, 2022 |
Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. INDEX TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Unaudited Interim Condensed Consolidated Financial Statements PAGES Unaudited Interim Condensed Consolidated Balance Sheets as of December 31, 2021 and June 30, 2022 F-2 Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the Six Months Ended June 30, 2021 |
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August 15, 2022 |
Exhibit 99.2 RECENT DEVELOPMENT Unless otherwise stated or unless the context otherwise requires, the terms, ?we,? ?us,? ?our,? ?our Company,? ?Gracell? refer to Gracell Biotechnologies Inc. Results of Operations for the Six Months of 2022 Set forth below is a discussion of our unaudited statements of comprehensive loss data for the six months ended June 30, 2021 and 2022. In the below discussion, |
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August 15, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republi |
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August 2, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republi |
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August 2, 2022 |
Exhibit 99.1 Gracell Biotechnologies Appoints Accomplished Clinical Leader Dr. Wendy Li as Chief Medical Officer Dr. Li brings deep oncology clinical development, medical affairs and U.S. regulatory experience SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China (August 1, 2022) ? Gracell Biotechnologies Inc. (?Gracell? or the ?Company?, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company |
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August 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republi |
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August 1, 2022 |
Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on September 15, 2022 (or any adjournment(s) or postponement(s) thereof) On Thursday, September 15, 2022, Gracell Biotechnologies Inc. (the ?Company?) will hold its annual general meeting (?AGM?) of shareholders in a virtua |
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August 1, 2022 |
Exhibit 99.2 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) FORM OF PROXY FOR ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on September 15, 2022 (or any adjournment(s) or postponement(s) thereof) Introduction This Form of Proxy is furnished in connection with the solicitation by the Board of Directors of Gracell Biotechnologies Inc. (th |
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July 19, 2022 |
6-K 1 d384644d6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial P |
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June 28, 2022 |
June 28, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Jane Park Mr. Jason Drory Re: Gracell Biotechnologies Inc. Registration Statement on Form F-3 Filed June 17, 2022 File No. 333-264545 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended |
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June 17, 2022 |
CORRESP 1 filename1.htm Will H. Cai +852 3758 1210 [email protected] June 17, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Jane Park Mr. Jason Drory Re: Gracell Biotechnologies Inc. Amendment No. 1 to Registration Statement on Form F-3 Filed May 19, 2022 File No. 333-264545 Ladies an |
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June 17, 2022 |
As filed with the Securities and Exchange Commission on June 17, 2022 Table of Contents As filed with the Securities and Exchange Commission on June 17, 2022 Registration No. |
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June 14, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Presents Updated Clinical Data for BCMA/CD19 Dual-targeting FasTCAR GC012F in RRMM at EHA2022 Congress, Highlighting 100% MRD Negativity Rate in All Treated Patients Gracell also presented data on GC012F for treatment of B-NHL and allogeneic TruUCAR-candidate GC502 for treatment of B-ALL Management to host clinical update call on Monday, June 13, |
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June 14, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of June 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic |
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May 31, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic o |
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May 31, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies to Present Updated Clinical Data on BCMA/CD19 Dual-Targeting CAR-T GC012F for Relapsed/Refractory Multiple Myeloma at 2022 ASCO Annual Meeting SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China (May 26, 2022) ? Gracell Biotechnologies Inc. (?Gracell? or the ?Company?, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to deve |
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May 19, 2022 |
55 Hudson Yards, New York, New York 10001-2157 t: +1 212 479 6000 f: +1 212 479 6275 cooley.com Will H. Cai +852 3758 1210 [email protected] May 19, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Jane Park Mr. Jason Drory Re: Gracell Biotechnologies Inc. Registration Statement on Form F-3 Filed April 28, 2022 File No. 333-264545 Ladies and Gentlemen: On behalf of our client, Grac |
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May 19, 2022 |
As filed with the Securities and Exchange Commission on May 19, 2022 Table of Contents As filed with the Securities and Exchange Commission on May 19, 2022 Registration No. |
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May 17, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports First Quarter 2022 Unaudited Financial Results and Provides Corporate Update ? Presented early clinical data from a first-in-human Phase 1 investigator-initiated trial (IIT) of allogeneic TruUCAR candidate GC502 for relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) at AACR 2022; updated data to be presented at EHA 2022 ? |
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May 17, 2022 |
6-K 1 d343645d6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Pa |
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April 28, 2022 |
EX-FILING FEES 6 d337128dexfilingfees.htm EX-FILING FEES Exhibit 107 CALCULATION OF FILING FEE TABLE FORM F-3 (Form Type) GRACELL BIOTECHNOLOGIES INC. (Exact Name of Registrant as Specified in its Charter) Not Applicable (Translation of Registrant’s Name into English) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amo |
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April 28, 2022 |
Exhibit 1.2 Gracell Biotechnologies Inc. Shares of American Depositary Shares Each Representing Five Ordinary Shares (par value US$0.0001 per share) Controlled Equity OfferingSM Sales Agreement April 28, 2022 Cantor Fitzgerald & Co. 499 Park Avenue New York, NY 10022 BTIG, LLC 600 Montgomery Street San Francisco, CA 94111 Ladies and Gentlemen: Gracell Biotechnologies, Inc., an exempted company inc |
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April 28, 2022 |
Powers of Attorney (incorporated by reference to the signature page hereto) Table of Contents As filed with the Securities and Exchange Commission on April 28, 2022 Registration No. |
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April 22, 2022 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ? REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ? 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) |
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April 22, 2022 |
EX-13.2 Exhibit 13.2 Certification by the Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the annual report of Gracell Biotechnologies Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yili Kevin Xie, Chief Financial Officer |
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April 22, 2022 |
EX-12.1 Exhibit 12.1 Certification by the Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, William Wei Cao, certify that: 1. I have reviewed this annual report on Form 20-F of Gracell Biotechnologies Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the stat |
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April 22, 2022 |
Exhibit 4.18 Certain confidential information contained in this document, marked by [***], has been omitted because such information is both not material and is the type that Gracell Biotechnologies Inc. Company customarily and actually treats that as private or confidential. MANUFACTURING SERVICES AGREEMENT This Manufacturing Services Agreement (the ?Agreement?) is executed on March 31, 2021 and |
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April 22, 2022 |
Consent of PricewaterhouseCoopers Zhong Tian LLP, an independent Registered Public Accounting Firm EX-15.1 9 d273170dex151.htm EX-15.1 Exhibit 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (File No. 333-253486) of Gracell Biotechnologies Inc. of our report dated April 22, 2022 relating to the financial statements, which appears in this Form 20-F. /s/ PricewaterhouseCoopers Zhong Tian LL |
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April 22, 2022 |
Consent of Harney Westwood & Riegels EX-15.2 10 d273170dex152.htm EX-15.2 Exhibit 15.2 Date: April 22, 2022 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir or Madam: Gracell Biotechnologies Inc. (the Company) We are attorneys-at-law qualified to practise in the Cayman Islands and have been asked to provide this conse |
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April 22, 2022 |
Consent of AllBright Law Offices EX-15.3 Exhibit 15.3 Date: April 22, 2022 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir/Madam: We hereby consent to the reference to our firm and the summary of our opinion under the headings “Item 3. Key Information,” “Item 3. Key Information—D. Risk Factors—Risks Related to Ou |
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April 22, 2022 |
EX-12.2 Exhibit 12.2 Certification by the Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Yili Kevin Xie, certify that: 1. I have reviewed this annual report on Form 20-F of Gracell Biotechnologies; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements |
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April 22, 2022 |
Exhibit 4.17 Certain confidential information contained in this document, marked by [***], has been omitted because such information is both not material and is the type that Gracell Biotechnologies Inc. Company customarily and actually treats that as private or confidential. EXCLUSIVE LICENSE AGREEMENT THIS AGREEMENT is made and entered into on May 11, 2021 (hereinafter the ?Effective Date?) by a |
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April 22, 2022 |
EX-13.1 Exhibit 13.1 Certification by the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the annual report of Gracell Biotechnologies Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, William Wei Cao, Chief Executive Office |
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April 11, 2022 |
6-K 1 d315218d6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of April 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial |
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April 11, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies to Present Data at AACR Annual Meeting 2022 Showcasing Early First-in-Human Results for GC502 in r/r B-ALL Allogeneic, off-the-shelf CAR-T therapy with CD19/CD7 dual-directed CAR shows promising early results in patients with r/r B-ALL PALO ALTO, Calif. and SUZHOU, China (April 8, 2022) ? Gracell Biotechnologies Inc. (?Gracell? or the ?Company?, N |
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March 17, 2022 |
EXHIBIT A AGREEMENT Pursuant to Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, the undersigned hereby agree that only one statement containing the information required by Schedule 13G need be filed with respect to the ownership by each of the undersigned of Ordinary Shares of Gracell Biotechnologies Inc. |
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March 17, 2022 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. |
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February 22, 2022 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Doses First Patients in First-in-Human Clinical Trial Evaluating GC012F, its Dual-Targeting FasTCAR-T Therapy, in B-Cell Non-Hodgkin?s Lymphoma Candidate dual-targeting B cell maturation antigen (BCMA) and CD19 expands Gracell?s FasTCAR autologous, next-day manufacturing CAR-T platform SUZHOU, China, and PALO ALTO, Calif. (Feb.17, 2022) ? Gracell |
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February 22, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2022 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Repub |
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February 14, 2022 |
Exhibit 99.1 JOINT FILING AGREEMENT In accordance with Rule 13d-1(k) promulgated under the Securities Exchange Act of 1934, as amended, the undersigned hereby agree to the joint filing with all other Reporting Persons (as such term is defined in the Schedule 13G referred to below) on behalf of each of them of a statement on Schedule 13G (including amendments thereto) with respect to the ordinary s |
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February 14, 2022 |
GRCL / Gracell Biotechnologies Inc. / William Cao Wei - SCHEDULE 13G Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO ? 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO ? 240.13d-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934 (AMENDMENT NO. )* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary shares, $0.0001 par value per share (Title of Class of Secu |
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February 11, 2022 |
CUSIP No. 38406L103 SCHEDULE 13G Page 9 of 9 Pages EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on this Schedule 13G dated February 11, 2022 (the ?Schedule 13G?), with respect to the Ordinary Shares, par value $0.0001 per share, of Gracell Biotechnologies Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) und |
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February 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Gracell Biotechnologies Inc. (Name of Issuer) Common Stock (Title of Class of Securities) G4037L105 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which |
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February 11, 2022 |
GRCL / Gracell Biotechnologies Inc. / ORBIMED ADVISORS LLC - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. |
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February 9, 2022 |
GRCL / Gracell Biotechnologies Inc. / LAV Biosciences Fund V, L.P. - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Stock, US$0.0001 par value per share (Title of Class of Securities) 38406L103 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pur |
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February 4, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Gracell Biotechnologies Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 38406L103 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which |
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November 24, 2021 |
6-K 1 d248305d6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industri |
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November 24, 2021 |
Gracell Biotechnologies Announces Senior Management Team Share Purchase Plan Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Announces Senior Management Team Share Purchase Plan SUZHOU, China and PALO ALTO, Calif. Nov. 23, 2021 ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell? or the ?Company?), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced th |
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November 22, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Repub |
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November 22, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy Candidate GC012F for the Treatment of Multiple Myeloma SUZHOU and SHANGHAI, China, and PALO ALTO, Calif., Nov. 19, 2021 /PRNewswire/ ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicat |
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November 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Repub |
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November 16, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Third Quarter 2021 Unaudited Financial Results and Provides Corporate Update SUZHOU, China and PALO ALTO, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapie |
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August 18, 2021 |
EX-99.1 2 d182277dex991.htm EX-99.1 Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Second Quarter 2021 Unaudited Financial Results and Provides Corporate Update SUZHOU, China and PALO ALTO, Calif., August 17, 2021 (GLOBE NEWSWIRE) – Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly e |
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August 18, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republi |
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July 12, 2021 |
Voting Results of 2021 Annual General Meeting Exhibit 99.1 Voting Results of 2021 Annual General Meeting At Gracell Biotechnologies Inc.?s (the ?Company?) annual general meeting of shareholders held on July 9, 2021 (the ?AGM?), the Company?s shareholders: ? Elected Mr. Christophe Lee to serve as Class I director of the Company. A total of 263,917,715 ordinary shares, including those underlying ADSs, representing approximately 78.53% of the or |
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July 12, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic |
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June 4, 2021 |
Exhibit 99.1 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on July 9, 2021 (or any adjournment(s) or postponement(s) thereof) On Friday, July 9, 2021, Gracell Biotechnologies Inc. (the ?Company?), will hold its annual general meeting (?AGM?) of shareholders at Building 3, No. 418 G |
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June 4, 2021 |
Exhibit 99.2 GRACELL BIOTECHNOLOGIES INC. (incorporated in the Cayman Islands with limited liability) (NASDAQ: GRCL) FORM OF PROXY FOR ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on July 9, 2021 (or any adjournment(s) or postponement(s) thereof) Introduction This Form of Proxy is furnished in connection with the solicitation by the Board of Directors of Gracell Biotechnologies Inc. (the ?Com |
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June 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of June 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic |
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May 21, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies to Present Updated Results of GC012F FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma at ASCO 2021 and EHA 2021 SUZHOU, China and Palo Alto, California, May 19, 2021 ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicated to developin |
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May 21, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic o |
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May 20, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports First Quarter 2021 Unaudited Financial Results and Provides Corporate Update Reported updated long-term follow-up data for TruUCAR-enabled CD7-targeted CAR-T product candidate GC027 for the treatment of T-ALL at AACR 2021 Annual Meeting Signed agreement with Lonza to manufacture FasTCAR-enabled product candidates in the U.S. Completed init |
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May 20, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic o |
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May 11, 2021 |
Current Report of Foreign Issuer - FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic o |
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May 11, 2021 |
Gracell Biotechnologies Appoints Seasoned Gene & Cell Therapy Executive Dr. Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Appoints Seasoned Gene & Cell Therapy Executive Dr. Jenny (Yajin) Ni as Chief Technology Officer SUZHOU and SHANGHAI, China, May 11, 2021 ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, |
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April 23, 2021 |
EX-12.1 Exhibit 12.1 Certification by the Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, William Wei Cao, certify that: 1. I have reviewed this annual report on Form 20-F of Gracell Biotechnologies Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the stat |
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April 23, 2021 |
Exhibit 4.29 Contract No.: [2020 SYZBZ No. 811208071607] Contract of Maximum Guarantee (Version 2.0, 2018) Filling Instructions 1. This Contract shall be filled out with a blue black or black roller pen or pen. 2. This Contract shall be filled out completely, and the handwriting shall be clear and neat. 3. The currency shall be filled out in Chinese instead of a currency symbol. The Chinese name o |
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April 23, 2021 |
Exhibit 4.26 No.: 2021 SYD Zi No.811208077578 Working Capital (in RMB) Loan Contract (Ver. 1.0, 2021) Instructions for Filling I. This Contract shall be filled out with blue-black or black sign pen or pen. II. All blanks herein shall be filled out completely with clear and legible handwriting. III. The currency shall be filled out in Chinese characters rather than currency symbol. Chinese name of |
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April 23, 2021 |
Exhibit 4.27 Edition in June 2018 Contract of Maximum Guarantee (Model Text) Serial No. 11200S1520011A002 Creditor: Suzhou Branch of Industrial Bank Co., Ltd. Domicile: No.125 Wangdun Road, Suzhou Industrial Park Legal Representative/Principal: Wang Xuexiang Guarantor (Enterprise): Gracell Bioscience (Shanghai) Co., Ltd. Domicile: 10/F, Building No. 1, No.926 Yishan Road, Xuhui District, Shanghai |
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April 23, 2021 |
Exhibit 4.23 Edition February 2020 Working Capital Loan Contract (Model) No. 11201S1720018 Lender: Industrial Bank Co., Ltd. Suzhou Branch Domicile: 125 Wangdun Road, Suzhou Industrial Park Legal representative (person-in-charge): [***] Lender: Suzhou Gracell Biotechnologies Co., Ltd. Domicile: 218 Sangtian Street, Suzhou Industrial Park Legal representative (person-in-charge): /s/ Cao Wei Place o |
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April 23, 2021 |
Exhibit 4.21 Working Capital (in RMB) Loan Contract Contract No.: [***] Borrower (Party A): Suzhou Gracell Biotechnologies Co., Ltd. Domicile: Building 12, Block B, Biomedical Industrial Park Phase II, No. 218, Sangtian Street, Suzhou Industrial Park Zip code: 215123 Legal representative (person-in-charge): Cao Wei Fax: Tel.: [***] Lender (Party B): Suzhou Industrial Park Sub-branch of China Const |
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April 23, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ? REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ? 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) |
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April 23, 2021 |
EX-12.2 Exhibit 12.2 Certification by the Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Yili Kevin Xie, certify that: 1. I have reviewed this annual report on Form 20-F of Gracell Biotechnologies; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements |
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April 23, 2021 |
Exhibit 4.24 No. 2020 SYD Zi No.811208071607 Working Capital (in RMB) Loan Contract (Ver. 3.0, 2018) Instructions for Filling I. This Contract shall be filled out with blue-black or black sign pen or pen. II. All blanks herein shall be filled out completely with clear and legible handwriting. III. The currency shall be filled out in Chinese characters rather than currency symbol. Chinese name of t |
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April 23, 2021 |
Exhibit 2.5 Description of Rights of Securities Registered under Section 12 of the Securities Exchange Act of 1934 American Depositary Shares (?ADSs?), each representing five ordinary shares of Gracell Biotechnologies Inc. (?our company?) are listed on The Nasdaq Global Select Market and the shares are registered under Section 12(b) of the Securities Exchange Act of 1934 (the ?Exchange Act?). This |
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April 23, 2021 |
Exhibit 4.28 Edition in June 2018 Contract of Maximum Guarantee (Model Text) Serial No. 11200S1520011A001 Creditor: Suzhou Branch of Industrial Bank Co., Ltd. Domicile: No.125 Wangdun Road, Suzhou Industrial Park Legal Representative/Principal: Wang Xuexiang Gracell Biotechnologies (Shanghai) Co., Ltd. Guarantor (Enterprise): Gracell Biotechnologies (Shanghai) Co., Ltd. Domicile: 12/F, Building No |
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April 23, 2021 |
Consent of PricewaterhouseCoopers Zhong Tian LLP, an independent Registered Public Accounting Firm EX-15.1 Exhibit 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (No. 333-253486) of Gracell Biotechnologies Inc. of our report dated April 23, 2021 relating to the financial statements, which appears in this Form 20-F. /s/ PricewaterhouseCoopers Zhong Tian LLP Shanghai, the People’s Republic |
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April 23, 2021 |
Exhibit 4.20 Working Capital (in RMB) Loan Contract Contract No.: [***] Borrower (Party A): Suzhou Gracell Biotechnologies Co., Ltd. Domicile: Building 12, Block B, Biomedical Industrial Park Phase II, No. 218, Sangtian Street, Suzhou Industrial Park Zip code: 215123 Legal representative (person-in-charge): Cao Wei Fax: This column is left blank Tel.: [***] Lender (Party B): Suzhou Industrial Park |
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April 23, 2021 |
Exhibit 4.25 No. 2020 SYD Zi No.811208071621 Working Capital (in RMB) Loan Contract (Ver. 3.0, 2018) Instructions for Filling I. This Contract shall be filled out with blue-black or black sign pen or pen. II. All blanks herein shall be filled out completely with clear and legible handwriting. III. The currency shall be filled out in Chinese characters rather than currency symbol. Chinese name of t |
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April 23, 2021 |
Consent of Harney Westwood & Riegels Exhibit 15.2 Date: April 23, 2021 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir or Madam: Gracell Biotechnologies Inc. (the “Company”) We are attorneys-at-law qualified to practise in the Cayman Islands and have been asked to provide this consent to you with regard to the laws o |
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April 23, 2021 |
EX-13.1 Exhibit 13.1 Certification by the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of Gracell Biotechnologies Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, William Wei Cao, Chief Executive Office |
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April 23, 2021 |
EX-13.2 Exhibit 13.2 Certification by the Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of Gracell (the “Company”) on Form 20-F for the fiscal year ended December 31, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yili Kevin Xie, Chief Financial Officer of the Company, cert |
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April 23, 2021 |
Consent of AllBright Law Offices EX-15.3 Exhibit 15.3 Date: April 23, 2021 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China Dear Sir/Madam: We hereby consent to the reference to our firm and the summary of our opinion under the headings, “Item 3. Key Information—D. Risk Factors—Risks Related to Our Corporate Structure”, “I |
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April 12, 2021 |
Current Report of Foreign Issuer - FORM 6-K 6-K 1 d140966d6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of April 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial |
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April 12, 2021 |
Gracell Biotechnologies Reports Long-term Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Long-term Follow-up Data on TruUCAR-enabled GC027 in Relapsed/Refractory T-ALL at the AACR 2021 Annual Meeting SUZHOU and SHANGHAI, China, April 10, 2021 ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for t |
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April 6, 2021 |
Current Report of Foreign Issuer - FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of April 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic |
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April 6, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Signs Agreement with Lonza to Manufacture Gracell?s FasTCAR Product Candidates in the U.S. The collaboration will help Gracell leverage Lonza?s worldwide integrated services and expertise in CAR-T cell therapy manufacturing SUZHOU, China and PALO ALTO, California, March. 31, 2021 /PRNewswire/? Gracell Biotechnologies Inc. (NASDAQ:GRCL)(?Gracell?), |
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April 6, 2021 |
Exhibit 99.2 PRESS RELEASE Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy for the Treatment of Relapsed or Refractory B-ALL SUZHOU and SHANGHAI, China, March 31, 2021 ? Gracell Biotechnologies Inc. (NASDAQ: GRCL) (?Gracell?), a global clinical-stage biopharmaceutical company dedicated to developi |
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March 15, 2021 |
Current Report of Foreign Issuer - FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of March 2021 Commission file number: 001-39838 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People?s Republic |
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March 15, 2021 |
Exhibit 99.1 PRESS RELEASE Gracell Biotechnologies Reports Fourth Quarter and Fiscal Year 2020 Unaudited Financial Results and Provides Corporate Update Reported interim readouts for lead CAR-T product candidates: FasTCAR-enabled dual-targeting BCMA/CD19 autologous CAR-T product candidate GC012F for the treatment of multiple myeloma and TruUCAR-enabled CD7-directed CAR-T product candidate GC027 fo |
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February 25, 2021 |
Exhibit 4.3 GRACELL BIOTECHNOLOGIES INC. AND THE BANK OF NEW YORK MELLON As Depositary AND OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES Deposit Agreement January 7, 2021 TABLE OF CONTENTS ARTICLE 1. DEFINITIONS 1 SECTION 1.1. American Depositary Shares 1 SECTION 1.2. Commission 2 SECTION 1.3. Company 2 SECTION 1.4. Custodian 2 SECTION 1.5. Deliver; Surrender 2 SECTION 1.6. Deposit Agreement 3 |
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February 25, 2021 |
As filed with the Securities and Exchange Commission on February 25, 2021 Registration No. |
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January 21, 2021 |
Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on Schedule 13D, dated January 21, 2021, with respect to the ordinary shares of Gracell Biotechnologies Inc. |
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January 21, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 Gracell Biotechnologies Inc. (Name of Issuer) ORDINARY SHARES, par value US$0.0001 per share (Title of Class of Securities) 38406L103** (CUSIP Number) OrbiMed Advisors LLC OrbiMed Asia GP III, L.P. OrbiMed Advisors III Limited OrbiMed Genesis GP LLC OrbiMed New Horizons GP |
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January 15, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Gracell Biotechnologies Inc. (Name of Issuer) Ordinary Shares, par value US$0.0001 per share (Title of Class of Securities) 38406L103 (CUSIP Number) January 7, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to desig |
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January 8, 2021 |
424(B)(4) Table of Contents Filed Pursuant to Rule 424(b)(4) Registration No. 333-251494 11,000,000 AMERICAN DEPOSITARY SHARES GRACELL BIOTECHNOLOGIES INC. Representing 55,000,000 Ordinary Shares This is an initial public offering of American depositary shares, or ADSs, representing ordinary shares of Gracell Biotechnologies Inc. We are offering 11,000,000 ADSs. Each ADS represents five ordinary s |
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January 7, 2021 |
AMENDMENT NO.3 TO FORM F-1 Table of Contents As filed with the Securities and Exchange Commission on January 7, 2021 Registration No. 333-251494 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 3 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRACELL BIOTECHNOLOGIES INC. (Exact name of Registrant as specified in its charter) Not Applicable |
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January 7, 2021 |
Free Writing Prospectus Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration No. |
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January 6, 2021 |
AMENDMENT NO.2 TO FORM F-1 Table of Contents As filed with the Securities and Exchange Commission on January 6, 2021 Registration No. 333-251494 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRACELL BIOTECHNOLOGIES INC. (Exact name of Registrant as specified in its charter) Not Applicable |
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January 6, 2021 |
Representation under Item 8.A.4 of Form 20-F EX-99.3 Exhibit 99.3 Gracell Biotechnologies Inc. Building 12, Block B, Phase II Biobay Industrial Park 218 Sangtian St. Suzhou Industrial Park, 215123 People’s Republic of China +86-512-6262-6701 January 6, 2021 VIA EDGAR Division of Corporation Finance Office of the Chief Accountant U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Gracell Biotechnologies Inc. |
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January 6, 2021 |
Will H. Cai +852 3758 1210 [email protected] January 6, 2021 VIA EDGAR U.S. Securities and Exchange Commission Office of Life Sciences Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Mr. Franklin Wyman Ms. Sasha Parikh Ms. Abby Adams Ms. Christine Westbrook Re: Gracell Biotechnologies Inc. Amendment No.2 to Registration Statement on Form F-1 and Respons |
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January 6, 2021 |
Citigroup Global Markets Inc. 388 Greenwich Street New York, New York 10013 Jefferies LLC 520 Madison Avenue New York, NY 10022 Piper Sandler & Co. 800 Nicollet Mall Minneapolis, Minnesota 55402 Wells Fargo Securities, LLC 500 West 33rd Street New York, NY 10001 As representatives of the several underwriters January 6, 2021 VIA EDGAR Mr. Franklin Wyman Ms. Sasha Parikh Ms. Abby Adams Ms. Christine |
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January 6, 2021 |
CORRESP 1 filename1.htm January 6, 2021 VIA EDGAR Mr. Franklin Wyman Ms. Sasha Parikh Ms. Abby Adams Ms. Christine Westbrook Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission 100 F Street, NE Washington, D.C., 20549 Re: Gracell Biotechnologies Inc. (CIK: 0001826492) Registration Statement on Form F-1 (File No. 333-251494) Registration Statement on Form |
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January 5, 2021 |
=============================================================== GRACELL BIOTECHNOLOGIES INC. |
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January 5, 2021 |
- PRE-EFFECTIVE AMENDMENT NO. 1 As filed with the Securities and Exchange Commission on January 5, 2021. Registration No. 333-251864 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 PRE-EFFECTIVE AMENDMENT NO. 1 TO THE FORM F-6 REGISTRATION STATEMENT under THE SECURITIES ACT OF 1933 For Depositary Shares GRACELL BIOTECHNOLOGIES (Exact name of issuer of deposited securities as specified in its charter) N/A (Translation o |
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January 4, 2021 |
EX-10.21 Exhibit 10.21 EXCLUSIVE LICENSE AGREEMENT [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because Gracell Biotechnologies Inc. has determined it is not material and would be competitively harmful if publicly disclosed. THIS AGREEMENT is made and entered into on April 19th , 2017 (hereinafter “EFFECTIVE DATE”) by and between ProMab |
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January 4, 2021 |
As filed with the Securities and Exchange Commission on January 4, 2021. Registration No. 333- SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-6 REGISTRATION STATEMENT under THE SECURITIES ACT OF 1933 For Depositary Shares GRACELL BIOTECHNOLOGIES (Exact name of issuer of deposited securities as specified in its charter) N/A (Translation of issuer's name into English) Cayman Island |
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January 4, 2021 |
EX-4 3 gracellopin.htm OPINION OF DEPOSITARY'S COUNSEL Emmet, Marvin & Martin, llp Counsellors at Law 120 Broadway New York, New York 10271 Tel: 212-238-3000 Fax: 212-238-3100 www.emmetmarvin.com January 4, 2021 The Bank of New York Mellon, as Depositary 240 Greenwich Street New York, New York, 10286 Re: American Depositary Shares representing ordinary shares of Gracell Biotechnologies Inc. Ladies |
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January 4, 2021 |
Opinion of AllBright Law Offices regarding certain PRC tax matters (included in Exhibit 99.2) Exhibit 99.2 Date: January 4, 2021 To: William Wei Cao, Chairman & CEO Gracell Biotechnologies Inc. Building 12, Block B, Phase II, Biobay Industrial Park, 218 Sangtian St., Suzhou Industrial Park, 215123 Re: Gracell Biotechnologies Inc. We are a firm of lawyers qualified to practice in the People’s Republic of China (the “PRC”). We have acted as PRC legal counsel to Gracell Biotechnologies Inc., |
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January 4, 2021 |
=============================================================== GRACELL BIOTECHNOLOGIES INC. |
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January 4, 2021 |
8-A12B UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-A FOR REGISTRATION OF CERTAIN CLASSES OF SECURITIES PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 GRACELL BIOTECHNOLOGIES INC. |
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January 4, 2021 |
Form of Underwriting Agreement EX-1.1 Exhibit 1.1 Gracell Biotechnologies Inc. [●] Ordinary Shares ($0.0001 par value per share) Each represented by American Depositary Shares Underwriting Agreement New York, New York [insert date], 2021 Citigroup Global Markets Inc. Jefferies LLC Piper Sandler & Co. Wells Fargo Securities, LLC As Representatives of the several Underwriters, c/o Citigroup Global Markets Inc. 388 Greenwich Stree |
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January 4, 2021 |
AMENDMENT NO.1 TO FORM F-1 Table of Contents As filed with the Securities and Exchange Commission on January 4, 2021 Registration No. 333-251494 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRACELL BIOTECHNOLOGIES INC. (Exact name of Registrant as specified in its charter) Not Applicable |
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January 4, 2021 |
CORRESP Will H. Cai +852 3758 1210 [email protected] January 4, 2021 VIA EDGAR U.S. Securities and Exchange Commission Office of Life Sciences Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Mr. Franklin Wyman Ms. Sasha Parikh Ms. Abby Adams Ms. Christine Westbrook Re: Gracell Biotechnologies Inc. Registration Statement on Form F-1 and Response to the S |
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January 4, 2021 |
EX-4.3 Exhibit 4.3 GRACELL BIOTECHNOLOGIES INC. AND THE BANK OF NEW YORK MELLON As Depositary AND OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES Deposit Agreement , 2021 TABLE OF CONTENTS ARTICLE 1. DEFINITIONS 1 SECTION 1.1. American Depositary Shares 1 SECTION 1.2. Commission 2 SECTION 1.3. Company 2 SECTION 1.4. Custodian 2 SECTION 1.5. Deliver; Surrender 2 SECTION 1.6. Deposit Agreement 3 SE |
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December 21, 2020 |
*FOIA Confidential Treatment Request* Confidential Treatment Requested by Gracell Biotechnologies Inc. |
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December 18, 2020 |
EX-10.18 Exhibit 10.18 Working Capital (in RMB) Loan Contract Contract No.: HTZ322988800LDZJ202000116 Borrower (Party A): Suzhou Gracell Biotechnologies Co., Ltd. Domicile: Building 12, Block B, Biomedical Industrial Park Phase II, No. 218, Sangtian Street, Suzhou Industrial Park Zip code: 215000 Legal representative (person-in-charge): Cao Wei Fax: This column is left blank. Tel.: [***] Lender (P |
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December 18, 2020 |
Exhibit 10.14 认购期权协议 Call Option Agreement 本认购期权协议下称“本协议”)由以下各方于 2020年 11月 10日在中华人民共和国(下称“中国”)上海签订: This Call Option Agreement (this “Agreement”) is executed by and among the following Parties as of November 10, 2020 in Shanghai, the People’s Republic of China (“China” or the “PRC”): 甲方: 亘利生物科技(上海)有限公司 地址: [***] Party A: Gracell Bioscience (Shanghai) Co., Ltd. Address: [***] 乙方: 华晓弥 身份证号码: [***] P |
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December 18, 2020 |
EX-10.15 Exhibit 10.15 Fixed Asset Loan Contract No. 2020 Yuan Zhong Dai Zi 007 Borrower: Gracell Biotechnologies (Suzhou) Co., Ltd. Business license no.: [***] Legal representative/Principal: Cao Wei Address: 12/F, Area B, Biomedical Industry Park Phase II, 218 Sangtian Street, Suzhou Industrial Park, Suzhou 215000 Account opening financial institution and A/C no.: Bank of China Dushuhu Sub-branc |
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December 18, 2020 |
EX-10.19 Exhibit 10.19 Working Capital (in RMB) Loan Contract Contract No.: HTZ322988800LDZJ202000182 Borrower (Party A): Suzhou Gracell Biotechnologies Co., Ltd. Domicile: Building 12, Block B, Biomedical Industrial Park Phase II, No. 218, Sangtian Street, Suzhou Industrial Park Zip code: 215123 Legal representative (person-in-charge): Cao Wei Fax: This column is left blank. Tel.: [***] Lender (P |
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December 18, 2020 |
EX-10.8 Exhibit 10.8 业务合作协议 Business Cooperation Agreement 本业务合作协议(下称“本协议”)由以下双方于 2019年 1月 3日在中华人民共和国(下称“中国”)上海市签署。 This Business Cooperation Agreement (this “Agreement”) is made and entered into by and between the following parties on January 3, 2019 in Shanghai, the People’s Republic of China (“China” or the “PRC”). 甲方: 亘利生物科技(上海)有限公司 地址: [***] Party A: Gracell Bioscience (Shanghai) Co., Ltd. Ad |
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December 18, 2020 |
EX-4.4 Exhibit 4.4 GRACELL BIOTECHNOLOGIES INC. SECOND AMENDED AND RESTATED SHAREHOLDERS AGREEMENT SECOND AMENDED AND RESTATED SHAREHOLDERS AGREEMENT THIS SECOND AMENDED AND RESTATED SHAREHOLDERS AGREEMENT (this “Agreement”) is made and entered into on October 20, 2020 by and among: (1) Gracell Biotechnologies Inc., an exempted company duly incorporated under the Laws of the Cayman Islands (the “C |
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December 18, 2020 |
Exhibit 10.9 股东表决权委托协议修正协议 Amendment to Voting Rights Proxy Agreement 本股东表决权委托协议修正协议 (以下称“本协议”)于2020年11月10 日由以下各方在上海市签订: This Amendment to Voting Rights Proxy Agreement (the “Agreement”) is made in Shanghai on November 10, 2020 among the following parties: 甲方:曹卫(下称 “委托方”) 身份证号码:[***] Party A: CAO, Wei (hereinafter “Entrusting Party “) ID No.: [***] 乙方:亘利生物科技(上海)有限公司 地址:[***] Party B: Gracell Biosc |
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December 18, 2020 |
EX-10.12 Exhibit 10.12 股权质押协议 Equity Pledge Agreement 本股权质押协议 (下称“本协议”)由下列各方于 2020 年 11 月 10日在中华人民共和国(下称“中国”)上海签订: This Equity Pledge Agreement (this “Agreement”) has been executed by and among the following parties on November 10, 2020 in Shanghai, the People’s Republic of China (“China” or the “PRC”): 甲方: 亘利生物科技(上海)有限公司 (下称“质权人”) 地址: [***] Party A: Gracell Bioscience (Shanghai) Co., Ltd. (herein |
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December 18, 2020 |
EX-10.13 Exhibit 10.13 认购期权协议修正协议 Amendment to Call Option Agreement 本认购期权协议修正协议(下称“ 本协议”)由以下各方于 2020年 11月 10日在中华人民共和国(下称“中国”)上海签订: This Amendment to Call Option Agreement (this “Agreement”) is executed by and among the following Parties as of November 10, 2020 in Shanghai, the People’s Republic of China (“China” or the “PRC”): 甲方: 亘利生物科技(上海)有限公司 地址: [***] Party A: Gracell Bioscience (Shanghai) Co |
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December 18, 2020 |
EX-10.17 Exhibit 10.17 Working Capital (in RMB) Loan Contract Contract No.: HTZ322988800LDZJ202000095 Borrower (Party A): Suzhou Gracell Biotechnologies Co., Ltd. Domicile: Building 12, Block B, Biomedical Industrial Park Phase II, No. 218, Sangtian Street, Suzhou Industrial Park Zip code: 215123 Legal representative (person-in-charge): Cao Wei Fax: This column is left blank. Tel.: [***] Lender (P |
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December 18, 2020 |
EX-10.21 Exhibit 10.21 EXCLUSIVE LICENSE AGREEMENT [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because Gracell Biotechnologies Inc. has determined it is not material and would be competitively harmful if publicly disclosed. THIS AGREEMENT is made and entered into on April 19th , 2017 (hereinafter “EFFECTIVE DATE”) by and between ProMab |
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December 18, 2020 |
EX-10.6 Exhibit 10.6 配偶同意函 Spouse Consent Letter 本人,CAO Jacqueline Jie [***],护照号码:[***]),为曹卫([***]公民,[***]号码:[***])之合法配偶。 The undersigned, CAO Jacqueline Jie (a [***]citizen with Passport No.: [***]), is the lawful spouse of CAO Wei (a [***] citizen with [***] No.: [***]). 本人在此无条件并不可撤销地同意曹卫于 2020年11月10日签署下列文件(下称“交易文件”),并同意按照以下文件的规定处置曹卫持有的、并登记在其名下的亘喜生物科技(上海)有限公司(“ 亘喜上海”)的股权: I hereby unconditionall |
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December 18, 2020 |
Principal subsidiaries of the Registrant EX-21.1 Exhibit 21.1 Principal Subsidiaries, Consolidated Affiliated Entity and Subsidiary of Consolidated Affiliated Entity of the Registrant Subsidiaries Place of Incorporation Gracell Biotechnologies Holdings Limited British Virgin Islands Gracell Biotechnologies (HK) Limited Hong Kong Gracell Biopharmaceuticals, Inc. United States Gracell Bioscience (Shanghai) Co., Ltd. People’s Republic of Ch |
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December 18, 2020 |
EX-3.1 Exhibit 3.1 THE COMPANIES LAW (AS AMENDED) OF THE CAYMAN ISLANDS THIRD AMENDED AND RESTATED MEMORANDUM AND ARTICLES OF ASSOCIATION OF GRACELL BIOTECHNOLOGIES INC. THE COMPANIES LAW (AS AMENDED) OF THE CAYMAN ISLANDS THIRD AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION OF GRACELL BIOTECHONOLOGIES INC. (adopted by a special resolution passed on October 14, 2020) 1. The name of the Company is |
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December 18, 2020 |
EX-10.2 Exhibit 10.2 GRACELL BIOTECHNOLOGIES INC. 2020 Share Incentive Plan (adopted by ordinary resolution passed on December 18, 2020 and effective immediately prior to the completion of the initial public offering of the ADSs representing the Company’s ordinary shares) ARTICLE 1 PURPOSE The purpose of the Plan is to promote the success and enhance the value of Gracell Biotechnologies Inc., an e |
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December 18, 2020 |
EX-10.20 Exhibit 10.20 Fixed Assets Loan Contract No.: 512HT2020104831 ☐ This Contract is a specific Contract under the Credit Extension Agreement numbered / (If this article is applicable, check the box). Lender: China Merchants Bank Co., Ltd. Suzhou Branch (hereinafter referred to as “Party A”) Borrower: Suzhou Gracell Biotechnologies Co., Ltd. (hereinafter referred to as “Party B”) Through frie |
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December 18, 2020 |
EX-10.3 Exhibit 10.3 GRACELL BIOTECHNOLOGIES INC. INDEMNIFICATION AGREEMENT This Indemnification Agreement (this “Agreement”) is made as of , by and between Gracell Biotechnologies Inc., an exempted company incorporated and existing under the laws of the Cayman Islands (the “Company”), and [Name of Director] ([US passport/ID]:[*]) WHEREAS, the Indemnitee has agreed to serve as a director or office |
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December 18, 2020 |
EX-4.2 Exhibit 4.2 SHARE CERTIFICATE Number Shares [NO. OF SHARES] Gracell Biotechnologies Inc. THIS SHARE CERTIFICATE CERTIFIES THAT as of [DATE], [NAME OF SHAREHOLDER] of [ADDRESS OF SHAREHOLDER] is the registered holder of NO. OF SHARE fully paid [SHARE CLASS] Share(s) of [PAR VALUE] par value per share in the above named Company which are held subject to, and transferable in accordance with, t |
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December 18, 2020 |
Exhibit 10.22 AMENDED AND RESTATED No.1 TO EXCLUSIVE LICENSE AGREEMENT WITH SUBLICENSING TERMS [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because Gracell Biotechnologies Inc. has determined it is not material and would be competitively harmful if publicly disclosed. This Amended and Restated Agreement (“Agreement”) is made effective No |
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December 18, 2020 |
Third Amended and Restated 2017 Employee Stock Option Plan EX-10.1 Exhibit 10.1 GRACELL BIOTECHNOLOGIES, INC. Third Amended and Restated 2017 Employee Stock Option Plan 1. PURPOSE: The purposes the Third Amended and Restated 2017 Employee Stock Option Plan is to attract and retain the best available personnel, to provide additional incentive to Employees, Directors and Consultants and to promote the success of the Company’s business. 2. DEFINITIONS AND IN |