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Correspondence 0001140361-24-009420 from APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)

APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)
Date: Feb. 26, 2024 · CIK: 0001998311 · Accession: 0001140361-24-009420

AI Filing Summary & Sentiment

File numbers found in text: 333-276696

Referenced dates: December 8, 2023, February 5, 2024

Date
February 26, 2024
Author
/s/ Will H. Cai
Form
CORRESP
Company
APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)

Letter

Will H. Cai

+852 3758 1210

wcai@cooley.com

February 26, 2024

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. Eric Atallah

Ms. Lynn Dicker

Mr. Daniel Crawford

Mr. Alan Campbell

Re:

APRINOIA Therapeutics Inc.

Registration Statement on Form F-1

Filed January 26, 2024

File No. 333-276696

Ladies and Gentlemen:

On behalf of our client, APRINOIA Therapeutics Inc. (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the letter dated February 5, 2024 (the “Comment Letter”). Concurrently with the submission of this letter, the Company is filing Amendment No. 1 to the Company’s Registration Statement on Form F-1 (the “Amendment No. 1”) and certain exhibits via EDGAR,

The Staff’s comments are repeated thereafter in bold and are followed by the Company’s responses. Page references in the text of this response letter correspond to the page numbers of Amendment No. 1. Capitalized terms used but not defined herein are used herein as defined in Amendment No. 1.

The Company respectfully advises the Staff that Amendment No. 1 contains the estimated price range and offering size, and that the Company will launch the road show as soon as legally permissible on or around February 29, 2024, subject to market conditions.

February 26, 2024

Page 2

Registration Statement on Form F-1

Prospectus Summary

Overview, page 1

1.

We note your revised disclosure on pages 3 and 86 that “[y]our tau degrader program is supported by Alzheimer’s Drug Discovery Foundation (“ADDF”) following their rigorous scientific review process.” Please revise to describe and provide the data from the ADDF’s “rigorous scientific review process.” Please also remove your characterizations of your degraders as “potent” as well as your statement that it is feasible for this class of molecules to achieve reasonable brain penetration as these statements appear to be premature given your current stage of development. You may summarize the results of your preclinical studies and discuss your beliefs regarding your product candidates without making conclusions as to efficacy.

In response to the Staff’s comment, the Company has revised pages 3 and 88 of Amendment No. 1.

The Offering, page 12

2.

Your disclosure elsewhere in the document indicates that certain of your outstanding convertible promissory notes will convert into ordinary shares upon the consummation of the IPO. Please revise your disclosure on page 13 and elsewhere throughout the prospectus, as appropriate, to disclose the number of ordinary shares that will be issued pursuant to these conversions. Alternatively, please advise.

In response to the Staff’s comment, the Company has revised pages 14 and 64 of Amendment No. 1.

Business

Our Next-Generation Diagnostics Pipeline, page 91

3.

We note your response to prior comment 3 and reissue in part. Please revise to state whether there were any adverse events in the cited trials and if so, describe them. We also note it appears there may have been other investigator initiated trials other than the Li et al and the Tagai et al trials. If so, disclose whether the results of the unidentified studies were similar to the results of the cited studies. To the extent they were not, describe the studies and their results.

In response to the Staff’s comment, the Company has revised pages 94 and 95 of Amendment No. 1.

55 Hudson Yards, New York, New York 10001-2157

t: +1 212 479 6000 f: +1 212 479 6275 cooley.com

February 26, 2024

Page 3

Collaborations, page 99

4.

We note your responses to prior comment 1 and to comment 18 from our letter dated December 8, 2023. We are unable to agree with your response to previous comment 18 indicating that you are not substantially dependent on these collaboration agreements given that you entered into them in furtherance of the development of a material product candidate that appears in your pipeline table. Please file these agreements as exhibits to your registration statement. To the extent you continue to disagree, please provide more information about your ability to develop this product candidate without relying on Lundbeck and/or AbbVie.

Additionally, please revise to describe the material terms of your agreements with Lundbeck and AbbVie, including the obligations of all parties to the agreements, the aggregate amounts of all potential milestone payments, quantify any royalty rates or provide a reasonable range, disclose who will own rights to technologies arising from the collaboration, who will have commercialization rights and disclose term and termination provisions.

In response to the Staff’s comment, the Company has filed the aforementioned collaboration agreements as Exhibits 10.14 - 10.21 to the Amendment No.1 and revised page 112 of Amendment No. 1 to describe the material terms of such agreements.

Management

Compensation of Directors and Officers, page 125

5.

Please revise to provide executive compensation information for the year ended December 31, 2023.

In response to the Staff’s comment, the Company has revised page 132 of Amendment No. 1.

* * *

55 Hudson Yards, New York, New York 10001-2157

t: +1 212 479 6000 f: +1 212 479 6275 cooley.com

If you have any questions regarding the response letter, please contact the undersigned by phone at +852-3758-1210 or via e-mail at wcai@cooley.com.

Very truly yours,
/s/ Will H. Cai

Show Raw Text
CORRESP
1
filename1.htm

     Will H. Cai

      +852 3758 1210

      wcai@cooley.com

    February 26, 2024

    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. Eric Atallah

              Ms. Lynn Dicker

              Mr. Daniel Crawford

              Mr. Alan Campbell

          Re:

            APRINOIA Therapeutics Inc.

              Registration Statement on Form F-1

              Filed January 26, 2024

              File No. 333-276696

    Ladies and Gentlemen:

    On behalf of our client, APRINOIA Therapeutics Inc. (the “Company”), we are responding to the
      comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the letter dated
      February 5, 2024 (the “Comment Letter”). Concurrently with the submission of this letter, the Company is filing Amendment No. 1 to the Company’s Registration Statement on Form F-1 (the “Amendment No. 1”) and certain exhibits via EDGAR,

    The Staff’s comments are repeated thereafter in bold and are followed by the Company’s responses. Page references in the text of this response letter correspond
      to the page numbers of Amendment No. 1. Capitalized terms used but not defined herein are used herein as defined in Amendment No. 1.

    The Company respectfully advises the Staff that Amendment No. 1 contains the estimated price range and offering size, and that the Company will launch the road
      show as soon as legally permissible on or around February 29, 2024, subject to market conditions.

       February 26, 2024

        Page 2

    Registration Statement on Form F-1

    Prospectus Summary

    Overview, page 1

              1.

              We note your revised disclosure on pages 3 and 86 that “[y]our tau degrader program is supported by Alzheimer’s Drug Discovery Foundation (“ADDF”) following their
                rigorous scientific review process.” Please revise to describe and provide the data from the ADDF’s “rigorous scientific review process.” Please also remove your characterizations of your degraders as “potent” as well as your statement that
                it is feasible for this class of molecules to achieve reasonable brain penetration as these statements appear to be premature given your current stage of development. You may summarize the results of your preclinical studies and discuss
                your beliefs regarding your product candidates without making conclusions as to efficacy.

              In response to the Staff’s comment, the Company has revised pages 3 and 88 of Amendment No. 1.

    The Offering, page 12

              2.

              Your disclosure elsewhere in the document indicates that certain of your outstanding convertible promissory notes will convert into ordinary shares upon the
                consummation of the IPO. Please revise your disclosure on page 13 and elsewhere throughout the prospectus, as appropriate, to disclose the number of ordinary shares that will be issued pursuant to these conversions. Alternatively, please
                advise.

              In response to the Staff’s comment, the Company has revised pages 14 and 64 of Amendment No. 1.

    Business

    Our Next-Generation Diagnostics Pipeline, page 91

              3.

              We note your response to prior comment 3 and reissue in part. Please revise to state whether there were any adverse events in the cited trials and if so, describe them.
                We also note it appears there may have been other investigator initiated trials other than the Li et al and the Tagai et al trials. If so, disclose whether the results of the unidentified studies were similar to the results of the cited
                studies. To the extent they were not, describe the studies and their results.

                In response to the Staff’s comment, the Company has revised pages 94 and 95 of Amendment No. 1.

     55 Hudson Yards, New York, New York 10001-2157

        t: +1 212 479 6000 f: +1 212 479 6275 cooley.com

    February 26, 2024

        Page 3

    Collaborations, page 99

              4.

              We note your responses to prior comment 1 and to comment 18 from our letter dated December 8, 2023. We are unable to agree with your response to previous comment 18
                indicating that you are not substantially dependent on these collaboration agreements given that you entered into them in furtherance of the development of a material product candidate that appears in your pipeline table. Please file these
                agreements as exhibits to your registration statement. To the extent you continue to disagree, please provide more information about your ability to develop this product candidate without relying on Lundbeck and/or AbbVie.

                Additionally, please revise to describe the material terms of your agreements with Lundbeck and AbbVie, including the obligations of all parties to the agreements, the aggregate
                  amounts of all potential milestone payments, quantify any royalty rates or provide a reasonable range, disclose who will own rights to technologies arising from the collaboration, who will have commercialization rights and disclose term
                  and termination provisions.

                In response to the Staff’s comment, the Company has filed the aforementioned collaboration agreements as Exhibits 10.14 - 10.21 to the Amendment No.1 and revised page 112 of Amendment No. 1 to
                  describe the material terms of such agreements.

    Management

    Compensation of Directors and Officers, page 125

              5.

              Please revise to provide executive compensation information for the year ended December 31, 2023.

              In response to the Staff’s comment, the Company has revised page 132 of Amendment No. 1.

    * * *

    55 Hudson Yards, New York, New York 10001-2157

        t: +1 212 479 6000 f: +1 212 479 6275 cooley.com

    If you have any questions regarding the response letter, please contact the undersigned by phone at +852-3758-1210 or via e-mail at wcai@cooley.com.

          Very truly yours,

          /s/ Will H. Cai

          Will H. Cai

          cc:

            Mark S. Shearman, Chief Executive Officer, APRINOIA Therapeutics Inc.

              Brian Achenbach, Chief Financial Officer, APRINOIA Therapeutics Inc.

              Lana Gladstein, General Counsel, APRINOIA Therapeutics Inc.

              Timothy Pitrelli, Esq., Cooley LLP

              Reid S. Hooper, Esq., Cooley LLP

              Leah Gonzales, Audit Partner, MaloneBailey, LLP

              Michael J. Blankenship, Winston & Strawn LLP