SEC Company Response from Clinuvel Pharmaceuticals (CUVL) — Jun 15, 2026
Clinuvel Pharmaceuticals Ltd
Date: June 15, 2026 · CIK: 0001290877 · Accession: 0001493152-26-028644
AI Filing Summary & Sentiment
Reasoning
Referenced dates: April 23, 2026
Letter
Clinuvel Pharmaceuticals Limited
June 15, 2026
Via EDGAR
Division of Corporation Finance
Office of Life Sciences
U.S. Securities and Exchange Commission
F Street, NE
Washington, D.C., 20549
Attention:
Vanessa Robertson
Bonnie Baynes Joe McCann Lauren Sprague Hamill
Re: Clinuvel Pharmaceuticals Limited
Amendment No. 3 to Draft Registration Statement on Form 20-F
Submitted April 17, 2026
CIK No. 0001290877
To Whom It May Concern:
This letter is in response to the letter dated April 23, 2026 from the staff (the "Staff") of the U.S. Securities and Exchange Commission (the "Commission") addressed to Clinuvel Pharmaceuticals Limited (the "Company," "we," and "our"). For ease of reference, we have recited the Staff's comment in this response and numbered it accordingly. We are including the requested updates in the public filing of the Registration Statement noted above(the "Registration Statement").
Amendment No. 3 to Draft Registration Statement on Form 20-F
Interim Consolidated Financial Statements for the six months ended December 31, 2025 and 2024 (Unaudited and Presented on an IFRS basis), page F-24
1. As your June 30, 2025 annual audited financial statements are prepared in accordance with U.S. GAAP, all interim unaudited financial statements required in the registration statement must also be prepared under U.S. GAAP as required by Item 8.A.5 of Form 20-F. Note that while foreign private issuers are allowed to initially include more current published information, that published data accommodation does not waive the underlying requirement for consistent accounting standards in a registration statement. Please revise to disclose the following:
● Revise to replace your current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared under U.S. GAAP that were due on April 1, 2026.
●
Please revise other areas of the document impacted by this change, including your capitalization table and Item 5. Operating and financial review and prospects.
Response : In response to the Staff's comments, we have revised our disclosures beginning on page F-24 of the Registration Statement to replace our current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared under U.S. GAAP and also revised other areas of the Registration Statement impacted by the change, including our capitalization table and Item 5. Operating and financial review and prospects.
We appreciate the assistance the Staff has provided with its comments. If you have any questions, please do not hesitate to call our counsel, Louis Taubman, Esq., of Hunter Taubman Fischer & Li LLC, at (917) 512-0827.
Very
truly yours,
/s/
Philippe Wolgen
Show Raw Text
CORRESP 1 filename1.htm Clinuvel Pharmaceuticals Limited June 15, 2026 Via EDGAR Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission 100 F Street, NE Washington, D.C., 20549 Attention: Vanessa Robertson Bonnie Baynes Joe McCann Lauren Sprague Hamill Re: Clinuvel Pharmaceuticals Limited Amendment No. 3 to Draft Registration Statement on Form 20-F Submitted April 17, 2026 CIK No. 0001290877 To Whom It May Concern: This letter is in response to the letter dated April 23, 2026 from the staff (the "Staff") of the U.S. Securities and Exchange Commission (the "Commission") addressed to Clinuvel Pharmaceuticals Limited (the "Company," "we," and "our"). For ease of reference, we have recited the Staff's comment in this response and numbered it accordingly. We are including the requested updates in the public filing of the Registration Statement noted above(the "Registration Statement"). Amendment No. 3 to Draft Registration Statement on Form 20-F Interim Consolidated Financial Statements for the six months ended December 31, 2025 and 2024 (Unaudited and Presented on an IFRS basis), page F-24 1. As your June 30, 2025 annual audited financial statements are prepared in accordance with U.S. GAAP, all interim unaudited financial statements required in the registration statement must also be prepared under U.S. GAAP as required by Item 8.A.5 of Form 20-F. Note that while foreign private issuers are allowed to initially include more current published information, that published data accommodation does not waive the underlying requirement for consistent accounting standards in a registration statement. Please revise to disclose the following: ● Revise to replace your current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared under U.S. GAAP that were due on April 1, 2026. ● Please revise other areas of the document impacted by this change, including your capitalization table and Item 5. Operating and financial review and prospects. Response : In response to the Staff's comments, we have revised our disclosures beginning on page F-24 of the Registration Statement to replace our current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared under U.S. GAAP and also revised other areas of the Registration Statement impacted by the change, including our capitalization table and Item 5. Operating and financial review and prospects. We appreciate the assistance the Staff has provided with its comments. If you have any questions, please do not hesitate to call our counsel, Louis Taubman, Esq., of Hunter Taubman Fischer & Li LLC, at (917) 512-0827. Very truly yours, /s/ Philippe Wolgen Name: Philippe Wolgen Title: Managing Director and Chief Executive Officer cc: Louis Taubman, Esq. Hunter Taubman Fischer & Li LLC