Correspondence 0001213900-24-076688 from Radiopharm Theranostics Ltd (RADX, RDPTF) (CIK 0001949257) (RADX)
Radiopharm Theranostics Ltd (RADX, RDPTF) (CIK 0001949257)
Date: Sept. 9, 2024 · CIK: 0001949257 · Accession: 0001213900-24-076688
AI Filing Summary & Sentiment
File numbers found in text: 001-41621
Referenced dates: August 22, 2024
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CORRESP
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filename1.htm
September 9, 2024
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Gary Newberry
Kevin Kuhar
Lauren Hamill
Suzanne Hayes
Re: Radiopharm Theranostics Limited
Amendment No. 3 to Registration Statement
on Form 20FR12B
Filed July 25, 2024
File No. 001-41621
Ladies and Gentlemen:
On behalf of Radiopharm Theranostics Limited (the
“Company”), we are providing this letter in response to comments (the “Comments”) received from
the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) by
letter dated August 22, 2024, with respect to Amendment No. 3 to the Company’s Registration Statement on Form 20-F that was filed
on July 25, 2024.
The Company is concurrently filing Amendment No.
4 to its Registration Statement on Form 20-F, which includes changes made in response to the Comments and certain other
changes (the “Amendment No. 4”).
Set forth below is the Company’s response
to the Comments, which for your convenience we have incorporated into this response letter. Capitalized terms used in this response letter
but not otherwise defined in this response letter shall have the meanings set forth in Amendment No. 4.
Amendment No. 3 to Registration Statement
on Form 20FR12B
Item 4. Information on the Company, page 23
1. We note the description of your agreement
with Lantheus on page 23, which indicates that Lantheus purchased ordinary shares for a total
value of A$7.5 million and retains the right to purchase ordinary shares for an additional
amount of A$7.5 million for the six months following the execution of the agreement. Please
revise the description of the agreement here and on page 72 to disclose the number of shares
purchased and the number of shares they have the right to purchase. Additionally, the disclosure
on page 72 indicates that you will issue options to Lantheus. Please clarify if they currently
have the right to purchase additional shares. If they do not, clarify when the options will
be issued and when they expire.
The Company respectfully advises that
it has revised the disclosure on pages 23 and 72.
Our Licensed Platform Technologies, page 27
2. We note that in numerous places throughout
this section, you disclose the potential timing of planned clinical trials for certain product
candidates without first addressing whether you have sought or obtained the requisite regulatory
approval to commence such trials. Please revise throughout this section to disclose whether
you have sought or received regulatory approval and the specific indication(s) for which
each of your product candidates are being studied or will be studied in all of your ongoing
or planned clinical trials. To the extent you are conducting trials related to treatment
of cancer, please indicate the types of cancer(s). By way of example only and not limitation:
● On
page 27, clarify whether you have Ethics Committee approval for, or have applied for approval
of, your Phase I trial for RAD202 expected in 2H 2024, and for which indication(s); and
● Disclose
the indication(s) you are studying in the ongoing Phase 1 trial for RAD 204, and those you
plan to study in the planned US Phase II trial of RAD 204.
The Company respectfully advises that
it has revised the disclosure on pages 27, 28, 29, 30, 31.
3. Given your agreement to transfer
TROP2 and DUNP19 to Lantheus Holding, please remove the discussion of your plans to develop
the DUNP19 clinical asset from this section or otherwise advise.
The Company respectfully advises that
it has revised the disclosure on pages 24, 28, 31, 72 and F-41
B. Related Party Transactions, page 62
4. Please delete the statement that
the related party transaction were negotiated at arm’s length. Related party transactions
by their nature are not arm’s length transactions.
The Company respectfully advises that
it has revised the disclosure on page 62.
Item 10. Additional Information
Technology Commercialization Agreements with
MD Anderson, page 70
5. Please supplement your disclosure regarding
the amended Technology Commercialization Agreement with MD Anderson to quantify all amounts
paid to date and the minimum annual royalties due under the agreement, if applicable.
The Company respectfully advises that
it has revised the disclosure on page 71.
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Index to Consolidated Financial Statements, page
F-1
6. As an emerging growth company that
qualifies as a smaller reporting company, you are required to provide two years of financial
statements. You have also presented financial statements for the fiscal years ended June
30, 2022 and 2021 starting on page F-55. Please revise or advise.
The Company respectfully advises that
Item 8.A.2 to Form 20-F requires three years of financial statements and, as a result, the Company has included audited annual
financial statements for fiscal years 2023, 2022 and 2021. While the Company is an emerging growth company, Instruction 4 to Item
8.A.2. does not permit the Company to present just two years of audited financial statements because the Registration Statement
does not involve an initial public offering of equity securities.
The Company also respectfully advises
that a foreign private issuer, such as the Company, cannot qualify as smaller reporting company.
Consolidated Statements of Comprehensive Income/(Loss),
page F-3
7. Please present the basic and diluted loss per
share here and on page F-100 to the nearest whole cent so as not to imply more precision
than exists in this calculation.
The Company respectfully advises that
it has revised the disclosure on pages F-3 and F-100.
* * * * *
Please feel free to contact me on +61 403 292 589 (in your late afternoon
or early evening, given the time zone difference with Sydney) or email andrew.reilly@rimonlaw.com.
Very truly yours,
/s/ Andrew Reilly
Andrew Reilly
Partner
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