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SEC Comment Letter 0000000000-24-002444 to APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)

APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)
Date: March 5, 2024 · CIK: 0001998311 · Accession: 0000000000-24-002444

AI Filing Summary & Sentiment

File numbers found in text: 333-276696

Date
March 5, 2024
Author
Not clearly detected
Form
UPLOAD
Company
APRINOIA Therapeutics Inc. (APRI) (CIK 0001998311)

Letter

United States securities and exchange commission logo March 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. Amendment No. 1 to Registration Statement on Form F-1 Filed February 26, 2024 File No. 333-276696 Dear Mark S. Shearman: We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our February 5, 2024 letter. Amendment No. 1 to Registration Statement on Form F-1 Prospectus Summary Overview, page 1 1.We note your revised disclosure in response to prior comment 1 and reissue in part. Please revise to describe the ADDF’s “rigorous scientific review process.” Our Pipeline, page 4 2.We note your revised disclosure indicating that you plan to submit an NDA for APN-1607 in the fourth quarter of 2026. Given that you have yet to commence or complete the Phase 3 trial for this product candidate, please revise here and throughout to remove this statement. You may state when you anticipate commencing the pivotal trial for APN- 1607.

FirstName LastNameMark S. Shearman, Ph.D. Comapany NameAPRINOIA Therapeutics Inc. March 5, 2024 Page 2 FirstName LastNameMark S. Shearman, Ph.D. APRINOIA Therapeutics Inc. March 5, 2024 Page 2 Risk Factors General Risk Factors An active trading market for our ordinary shares may not be available . . . ., page 53 3.Please revise this risk factor to clearly state that stock price volatility, including any stock- run up, may be unrelated to your actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of your stock. Capitalization, page 64 4.Please revise your filing to clearly describe the nature of the transaction that resulted in a $4.45 million increase to your cash on a pro forma basis. Management's Discussion and Analysis of Financial Condition and Results of Operations Share-Based Compensation, page 83 5.We note that you have updated your filing with an estimated price range. As previously requested in comment 15 of our December 8, 2023 comment letter, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the initial public offering and the estimated offering price. Please discuss with the staff how to submit your response. Business Summary of Safety for APN-1607, page 94 6.We note your revised disclosure in response to prior comment 3. Please revise to remove your statement that APN-1607 "was demonstrated to have a favorable safety profile." You may describe the data supporting your conclusion. Preclinical Results, page 105 7.We note your revised disclosure providing data from preclinical tests for APNmAb005. Please revise to state whether any of these tests were powered for statistical significance. If so, revise to provide the p-values and state whether the results were statistically significant. License Agreements and Collaborations Research Collaboration Agreement with Lundbeck and Abbvie, page 112 8.We note your response to prior comment 4 and reissue in part. Please revise to describe the material terms of your agreement with Lundbeck and AbbVie, including the obligations of all parties to the agreement, the aggregate payments made and/or received to date, 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

FirstName LastNameMark S. Shearman, Ph.D. Comapany NameAPRINOIA Therapeutics Inc. March 5, 2024 Page 3 FirstName LastName Mark S. Shearman, Ph.D. APRINOIA Therapeutics Inc. March 5, 2024 Page 3 from the collaboration, who will have commercialization rights and disclose term and termination provisions. To the extent that any of these terms have not been negotiated pursuant to the existing collaboration agreement, please advise. 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.

Show Raw Text
United States securities and exchange commission logo
March 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.
Amendment No. 1 to Registration Statement on Form F-1
Filed February 26, 2024
File No. 333-276696
Dear Mark S. Shearman:
            We have reviewed your amended 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. Unless we note otherwise,
any references to prior comments are to comments in our February 5, 2024 letter.
Amendment No. 1 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your revised disclosure in response to prior comment 1 and reissue in part. Please
revise to describe the ADDF’s “rigorous scientific review process.”
Our Pipeline, page 4
2.We note your revised disclosure indicating that you plan to submit an NDA for APN-1607
in the fourth quarter of 2026. Given that you have yet to commence or complete the Phase
3 trial for this product candidate, please revise here and throughout to remove this
statement. You may state when you anticipate commencing the pivotal trial for APN-
1607.

 FirstName LastNameMark S. Shearman, Ph.D.
 Comapany NameAPRINOIA Therapeutics Inc.
 March 5, 2024 Page 2
 FirstName LastNameMark S. Shearman, Ph.D.
APRINOIA Therapeutics Inc.
March 5, 2024
Page 2
Risk Factors
General Risk Factors
An active trading market for our ordinary shares may not be available . . . ., page 53
3.Please revise this risk factor to clearly state that stock price volatility, including any stock-
run up, may be unrelated to your actual or expected operating performance and financial
condition or prospects, making it difficult for prospective investors to assess the rapidly
changing value of your stock.
Capitalization, page 64
4.Please revise your filing to clearly describe the nature of the transaction that resulted in a
$4.45 million increase to your cash on a pro forma basis.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Share-Based Compensation, page 83
5.We note that you have updated your filing with an estimated price range.  As previously
requested in comment 15 of our December 8, 2023 comment letter, please explain to us
how you determined the fair value of the common stock underlying your equity issuances
and the reasons for any differences between the recent valuations of your common stock
leading up to the initial public offering and the estimated offering price. Please discuss
with the staff how to submit your response.
Business
Summary of Safety for APN-1607, page 94
6.We note your revised disclosure in response to prior comment 3. Please revise to remove
your statement that APN-1607 "was demonstrated to have a favorable safety profile." You
may describe the data supporting your conclusion.
Preclinical Results, page 105
7.We note your revised disclosure providing data from preclinical tests for APNmAb005.
Please revise to state whether any of these tests were powered for statistical significance.
If so, revise to provide the p-values and state whether the results were statistically
significant.
License Agreements and Collaborations
Research Collaboration Agreement with Lundbeck and Abbvie, page 112
8.We note your response to prior comment 4 and reissue in part. Please revise to describe
the material terms of your agreement with Lundbeck and AbbVie, including the
obligations of all parties to the agreement, the aggregate payments made and/or received
to date, 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

 FirstName LastNameMark S. Shearman, Ph.D.
 Comapany NameAPRINOIA Therapeutics Inc.
 March 5, 2024 Page 3
 FirstName LastName
Mark S. Shearman, Ph.D.
APRINOIA Therapeutics Inc.
March 5, 2024
Page 3
from the collaboration, who will have commercialization rights and disclose term and
termination provisions. To the extent that any of these terms have not been negotiated
pursuant to the existing collaboration agreement, please advise.
            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.