SEC Comment Letter 0000000000-24-001368 to APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)
APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)
Date: Feb. 5, 2024 · CIK: 0001998311 · Accession: 0000000000-24-001368
AI Filing Summary & Sentiment
File numbers found in text: 333-276696
Referenced dates: December 8, 2023
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United States securities and exchange commission logo
February 5, 2024
Mark S. Shearman, Ph.D.
Chief Executive Officer
APRINOIA Therapeutics Inc.
245 Main Street, 2nd Floor
Cambridge, MA 02142
Re:APRINOIA Therapeutics Inc.
Registration Statement on Form F-1
Filed January 26, 2024
File No. 333-276696
Dear Mark S. Shearman:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on From 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.
FirstName LastNameMark S. Shearman, Ph.D.
Comapany NameAPRINOIA Therapeutics Inc.
February 5, 2024 Page 2
FirstName LastName
Mark S. Shearman, Ph.D.
APRINOIA Therapeutics Inc.
February 5, 2024
Page 2
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.
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.
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.
Management
Compensation of Directors and Officers, page 125
5.Please revise to provide executive compensation information for the year ended December
31, 2023.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameMark S. Shearman, Ph.D.
Comapany NameAPRINOIA Therapeutics Inc.
February 5, 2024 Page 3
FirstName LastName
Mark S. Shearman, Ph.D.
APRINOIA Therapeutics Inc.
February 5, 2024
Page 3
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Eric Atallah at 202-551-3663 or Lynn Dicker at 202-551-3616 if you have
questions regarding comments on the financial statements and related matters. Please contact
Daniel Crawford at 202-551-7767 or Alan Campbell at 202-551-4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Will H. Cai, Esq.