0000000000-21-002527.txt : 20210716 0000000000-21-002527.hdr.sgml : 20210716 20210303073006 ACCESSION NUMBER: 0000000000-21-002527 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20210303 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Ambrx Biopharma Inc. CENTRAL INDEX KEY: 0001836056 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 571147346 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 10975 NORTH TORREY PINES ROAD CITY: LA JOLLA STATE: CA ZIP: 92037 BUSINESS PHONE: (858) 729-3339 MAIL ADDRESS: STREET 1: 10975 NORTH TORREY PINES ROAD CITY: LA JOLLA STATE: CA ZIP: 92037 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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P(&]B:@H\/"]&:6QT97(O1FQA=&5$96-O9&4O5'EP M92]/8FI3=&TO3&5N9W1H(#(U."]&:7)S=" U,"].(#@^/G-T"$I*8*98BI0NDI'5&,J=4:]*4:4DIY4E.&-<)K=?BQKN!W1 H0W*X&?H_ 2ABY=P*96YD TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo March 2, 2021 Feng Tian Chairman, President and Chief Executive Officer Ambrx Biopharma Inc. 10975 North Torrey Pines Road La Jolla, California 92037 Re: Ambrx Biopharma Inc. Draft Registration Statement on Form F-1 Submitted February 3, 2021 CIK No. 0001836056 Dear Dr. Tian: We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form F-1, Submitted February 3, 2021 Summary Overview, page 1 1. Please balance your discussion in the Summary of the ongoing clinical trials related to your product candidates in China by clarifying that the clinical data discussed may not be accepted by the FDA or comparable foreign regulatory authorities, as you have stated in the risk factor on page 32. 2. Given your disclosures regarding AEs and SAEs on pages 148-150, please balance your statements concerning your product candidates being well-tolerated or potentially safer than other products in the Summary. Feng Tian FirstName LastNameFeng Tian Ambrx Biopharma Inc. Comapany March NameAmbrx Biopharma Inc. 2, 2021 March2 2, 2021 Page 2 Page FirstName LastName 3. Please explain what you mean by "potentially registrational" trials, as referenced throughout the prospectus. Our Product Pipeline, page 2 4. We note much of the trial disclosure is for studies conducted by NovoCodex. Please revise the Summary and the description of the License Agreement with NovoCodex for ARX788 on pages 112 and 167 to explain your ability and intent to use and rely upon NovoCodex s trial data. Please also revise the pipeline table to clarify which arrows reflect trials conducted by NovoCodex and in a footnote state the nature of your relationship and ability to use such data. 5. With respect to your pipeline table, please make the table and footnotes legible and remove the marketed column from your pipeline table as it implies likelihood of regulatory approval. Please also removed the planned trials from your table. 6. Please revise page 4 to define DCR. 7. We note your statement on page 6 that in preclinical models, ARX788 has demonstrated greater anti-tumor activity as a single agent compared to T-DM1, an approved ADC, in HER2-positive cancers. If this comparison reflects a head-to-head comparison please revise to state such. If not, please remove such comparison as comparisons to available products and other product candidates are not appropriate unless you have conducted head-to-head trials. ARX788, page 3 8. We note your statement on page 4 that you have "developed a clinical development strategy to accelerate the development of ARX788" and your emphasis throughout the prospectus on "accelerated development timelines". We contrast these statements with your risk factor on page 31 which states that accelerated approval by the FDA, even if granted, may not lead to faster development or regulatory review or approval. Please revise to balance your discussion in the Summary to clarify these points. Use of Proceeds, page 97 9. Please revise this section to provide more specific detail regarding the use of the funds to be allocated to the development and commercialization of ARX517 and your EPB product candidates, including reference to specific phases of preclinical and/or clinical trials, as applicable. Business Overview, page 130 10. We note your statement on page 130 that you observed a favorable safety profile in your Feng Tian FirstName LastNameFeng Tian Ambrx Biopharma Inc. Comapany March NameAmbrx Biopharma Inc. 2, 2021 March3 2, 2021 Page 3 Page FirstName LastName ongoing Phase 1 clinical trial of ARX788. Please revise this statement and all similar statements throughout your prospectus to remove implication that your product candidates are safe or effective, as these determinations are solely within the authority of the FDA and comparable regulatory bodies. Our Product Pipeline, page 142 11. Please provide the SAE details mentioned on page 27, including the one death, in your description of the applicable study for ARX788 in the Business section. Summary of ARX788 Clinical Results, page 144 12. Please revise page 146 and 148 to define EOT, SD and PR shown in the graphics. Our Collaborations, page 167 13. Please revise page 169 to provide the royalty term of the License Agreement with Agensys. 14. On page 171 you state that the License Agreement with The Regents will terminate upon the expiration of the last to expire patent or abandonment of the last to be abandoned patent application licensed under the agreement. Please revise to state when these patents are expected to expire, and also the royalty term. 15. One page 172 you state that the License Agreement with Calibr terminates upon the expiration of the last payment obligations under the agreement. Please revise to state the payment obligations under the agreement, including any royalties or milestone payments. 16. With respect to the Elanco License Agreement, please revise page 172 to disclose the aggregate upfront and milestone payments received to date, the term and termination provisions of the agreement, the aggregate potential milestone payments to be received, and the royalty term. In addition, we note you have listed the Elanco partnership in the collaboration pipeline table on page 140 but have not filed the related License Agreement as an exhibit. Please either file the License Agreement pursuant to Item 601(b)(10) of Regulation S-K, or provide an analysis as to why you do not believe filing is required. If you do not consider the agreement material, please remove the collaboration from the table. Intellectual Property, page 176 17. Please revise page 178 to state the material foreign jurisdictions covered by your patents with respect to each of your EuCODE mammalian platform and the ReCODE bacterial platform, respectively. Description of American Depositary Shares Governing Law, page 252 We note on page 252 that your forum selection provision identifies state and federal Feng Tian FirstName LastNameFeng Tian Ambrx Biopharma Inc. Comapany March NameAmbrx Biopharma Inc. 2, 2021 March4 2, 2021 Page 4 Page FirstName LastName 18. courts in New York, New York as the exclusive forum for certain litigation. Please disclose whether this provision applies to actions arising under the Securities Act or Exchange Act. If so, please also state that there is uncertainty as to whether a court would enforce such provision. If the provision applies to Securities Act claims, please also state that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. In that regard, we note that Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If this provision does not apply to actions arising under the Securities Act or Exchange Act, please also ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Please also revise your statement on page 82 where you refer to state and federal courts in New York as having non-exclusive jurisdiction over matters arising under the deposit agreement to clarify that such statement does not apply to suits by investors, which must exclusively be filed in a state or federal court in New York, New York. Exhibits 19. Please file the Shanghai Option Agreement as an exhibit pursuant to Item 601(b)(10)(i)(A) of Regulation S-K. 20. On page 256 you state that the matters discussed in this section related to US federal income tax law are the opinion of Cooley LLP, and the discussion of Cayman Islands tax law are the opinion of Harney Westwood & Riegels; however, no tax opinions have been filed as exhibits. Please file tax opinions in relation to the opinions expressed on pages 256-261, or advise. See Section III of Staff Legal Bulletin No. 19 for guidance. General 21. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. You may contact Michael Fay at 202-551-3812 or Brian Cascio at 202-551-3676 if you have questions regarding comments on the financial statements and related matters. Please contact Margaret Schwartz at 202-551-7153 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Feng Tian Ambrx Biopharma Inc. March 2, 2021 Page 5 FirstName LastNameFeng Tian Division of Corporation Finance Comapany NameAmbrx Biopharma Inc. Office of Life Sciences March 2, 2021 Page 5 cc: Sean Clayton, Esq. FirstName LastName