SecProbe.io

CORRESP
 1
 filename1.htm

 December 19, 2025

 via EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, DC 20549

 Re:
 Radiopharm Theranostics Limited

 Registration Statement on Form F-3

 Filed December 17, 2025

 File No. 333-292198

 Request for Acceleration of Effectiveness

 Ladies and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, Radiopharm Theranostics Limited (the "Registrant") respectfully requests
acceleration of its Registration Statement on Form F-3 (File No. 333-292198), filed on December 17,
2025, so that it will become effective at 9:00 a.m. (Eastern time) on December 23, 2025, or as soon as practicable thereafter.

 If you have any questions, or require any
additional information, please do not hesitate to email Andrew Reilly, the Registrant's outside counsel, at andrew.reilly@rimonlaw.com.

 The Registrant acknowledges that, if the Securities
and Exchange Commission (or its staff, acting pursuant to delegated authority) (the "Commission") declares the filing effective,
such action:

 (i)
 does not foreclose the Commission from taking any action with respect to the filing;

 (ii)
 does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 (iii)
 may not be asserted by the Registrant as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

 Very truly yours,

 Radiopharm Theranostics Limited

 /s/ Riccardo Canevari

 Riccardo Canevari

 Chief Executive Officer and

Managing Director

CORRESP
 1
 filename1.htm

 December 19, 2025

 via EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, DC 20549

 Re:
 Radiopharm Theranostics Limited

 Registration Statement on Form F-3

 Filed December 16, 2025

 File No. 333-292178

 Request for Acceleration of Effectiveness

 Ladies and Gentlemen:

 Pursuant to Rule 461 under the Securities
Act of 1933, Radiopharm Theranostics Limited (the "Registrant") respectfully requests acceleration of its Registration Statement
on Form F-3 (File No. 333-292178), filed on December 16, 2025, so that it will become effective at 9:00
a.m. (Eastern time) on December 23, 2025, or as soon as practicable thereafter.

 If you have any questions, or require any
additional information, please do not hesitate to email Andrew Reilly, the Registrant's outside counsel, at andrew.reilly@rimonlaw.com.

 The Registrant acknowledges that, if the Securities
and Exchange Commission (or its staff, acting pursuant to delegated authority) (the "Commission") declares the filing effective,
such action:

 (i)
 does not foreclose the Commission from taking any action with respect to the filing;

 (ii)
 does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 (iii)
 may not be asserted by the Registrant as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

 Very truly yours,

 Radiopharm Theranostics Limited

 /s/ Riccardo Canevari

 Riccardo Canevari

 Chief Executive Officer and

Managing Director

CORRESP
1
filename1.htm

December 11, 2024

via EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

    Re:
    Radiopharm Theranostics Limited

Registration Statement on Form F-1

Filed December 5, 2024

File No. 333-283627

Request for Acceleration of Effectiveness

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities
Act of 1933, Radiopharm Theranostics Limited (the “Registrant”) respectfully requests acceleration of its Registration Statement
on Form F-1 (File No. 333-283627), filed on December 5, 2024, so that it will become effective at 9:00 a.m.
(Eastern time) on December 13, 2024, or as soon as practicable thereafter.

If you have any questions, or require any
additional information, please do not hesitate to email Andrew Reilly, the Registrant’s outside counsel, at andrew.reilly@rimonlaw.com.

The Registrant acknowledges that, if the Securities
and Exchange Commission (or its staff, acting pursuant to delegated authority) (the “Commission”) declares the filing effective,
such action:

 (i) does
not foreclose the Commission from taking any action with respect to the filing;

 (ii) does
not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 (iii) may
not be asserted by the Registrant as a defense in any proceeding initiated by the Commission or any person under the federal securities
laws of the United States.

    Very truly yours,

    Radiopharm Theranostics Limited

    /s/ Riccardo Canevari

    Riccardo Canevari

    Chief Executive Officer and

    Managing Director

December 10, 2024
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Limited
Level 3, 62 Lygon Street
Carlton, VIC 3053
Australia
Re:Radiopharm Theranostics Limited
Registration Statement on Form F-1
Filed December 5, 2024
File No. 333-283627
Dear Riccardo Canevari:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
            Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrew Reilly, Esq.

CORRESP
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November 25, 2024

Via EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

    Attn:

    Gary Newberry

    Kevin Vaughn

    Lauren Hamill

    Suzanne Hayes

    RE:
    Radiopharm Theranostics Limited

    Registration Statement on Form 20-FR12B

    File No 001-41621

Ladies and Gentlemen:

The undersigned registrant hereby requests that the effectiveness of
the above captioned Registration Statement on Form 20-F, initially filed with the U.S. Securities and Exchange Commission on February
13, 2023, as thereafter amended, be accelerated so that it will be made effective at 9am Eastern Time on November 27, 2024, or as soon
thereafter as practicable, pursuant to Section 12(d) and Rule 12d1-1 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”).

The undersigned registrant hereby requests accelerated effectiveness
in connection with the completion of the registration of the undersigned registrant’s ordinary shares as represented by American
Depositary Shares, under Section 12(b) of the Exchange Act, and planned listing on the Nasdaq Capital Market.

Once the Registration Statement has been declared effective, please
confirm it with our counsel, Rimôn Law Pty Ltd, by emailing Andrew Reilly at andrew.reilly@rimonlaw.com.

    Very truly yours,

    Radiopharm Theranostics Limited

    By:
    /s/ Riccardo Canevari

    Riccardo Canevari

    Chief Executive Officer and

Managing Director

CORRESP
1
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November 5, 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. 6 to Registration Statement
on Form 20FR12B

Filed October 21, 2024

File No. 001-41621

Ladies and Gentlemen:

On behalf of Radiopharm Theranostics Limited (the
“Company”), we are providing this letter in response to a comment (the “Comment”) received from
the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) by letter
dated November 1, 2024, with respect to Amendment No. 6 to the Company’s Registration Statement on Form 20-F that was filed on October
21, 2024.

Set forth below is the Company’s response to
the Comment, which for your convenience we have incorporated into this response letter.

Amendment No. 6 to Registration Statement on
Form 20FR12B

D. Risk Factors, page 1

1. Please include a risk factor discussing the going concern opinion issued by your auditors and the potential
consequences with respect to raising capital.

The Company respectfully advises that
the going concern opinion included in the audit opinion for fiscal 2023 (see page F-50 of Amendment No. 6) has been lifted in the audit
opinion for fiscal 2024 (see page F-2 of Amendment No. 6). The Company’s auditors lifted the going concern opinion for fiscal 2024
because the Company has sufficient cash and cash equivalents to fund its operations until July 2026, as disclosed on page 47 of Amendment
No. 6, following a private placement of ordinary shares and options that was completed in two tranches, in June 2024 and in August 2024.

As a result, the Company believes there
is currently no risk that should be disclosed in the risk factors section of its Registration Statement on Form 20-F regarding a going
concern opinion issued by its auditors.

*          *          *          *          *

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

November 1, 2024
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Amendment No. 6 to Registration Statement on Form 20FR12B
Filed October 21, 2024
File No. 001-41621
Dear Riccardo Canevari:
            We have reviewed your filing and have the following comment.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response and any amendment you may file in response to this
letter, we may have additional comments.
Amendment No. 6 to Registration Statement on Form 20FR12B
D. Risk Factors, page 1
1.Please include a risk factor discussing the going concern opinion issued by your
auditors and the potential consequences with respect to raising capital.
            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.

November 1, 2024
Page 2

            Please contact Gary Newberry at 202-551-3761 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at 202-551-3675
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Alberto Pacchioni

CORRESP
1
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September 25, 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. 4 to Registration Statement on Form
                                            20FR12B   Filed September 9, 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 September 16, 2024, with respect to Amendment No. 4 to the Company’s Registration Statement on Form 20-F that was filed on
September 9, 2024.

The Company is concurrently filing Amendment No.
5 to its Registration Statement on Form 20-F, which includes changes made in response to the Comments and certain other
changes (the “Amendment No. 5”).

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. 5.

Amendment No. 4 to Registration Statement on
Form 20FR12B

Item 4. Information on the Company, page 23

 1. We note your revisions to pages 23 and 72 in response to prior comment 1. Please further revise to
disclose the number of ordinary shares Lantheus Omega has the right to purchase under the terms of the options issued in August 2024.

The Company respectfully advises that
it has revised the disclosure on pages 23 and 72.

Operating and Financial Review and Prospects,
page 44

 2. You disclose on page 45 that the significant increase in your Research and development expenses was
due to expenses incurred to conduct your clinical trials related to the development of RAD101, RAD202 and RAD204, and expenses related
to the clinical programs developed by Radiopharm Ventures. Given the 79% increase, please revise to address the following regarding this
increase in Research and development expenses:

 ● Disclose the extent to which you track Research and development expenses by product candidate. If you
do not track any expenses by product candidate, disclose that fact. For amounts that are tracked by product candidate, revise to provide
a breakdown by product candidate.

 ● For any amounts that are not tracked by product candidate, provide a breakdown by type or nature of
expenses such that the total reconciles to the line item for each period presented.

The Company respectfully advises that
it has revised the disclosure on page 45.

Item 6. Directors, Senior Management and Employees,
page 51

 3. Please revise the disclosure pertaining to Dimitris Voliotis to clearly indicate his business experience
for the past five years. In this regard, we note that you have not included applicable dates or ranges from which investors can discern
his principal occupations and employment during such time period as you have for your other executives.

The Company respectfully advises that
it has revised the disclosure on page 51.

*          *          *          *          *

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

September 16, 2024
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Amendment No. 4 to Registration Statement on Form 20FR12B
Filed September 9, 2024
File No. 001-41621
Dear Riccardo Canevari:
            We have reviewed your filing and have the following comments.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments.
Amendment No. 4 to Registration Statement on Form 20FR12B
Item 4. Information on the Company, page 23
1.We note your revisions to pages 23 and 72 in response to prior comment 1. Please further
revise to disclose the number of ordinary shares Lantheus Omega has the right to purchase
under the terms of the options issued in August 2024.
Operating and Financial Review and Prospects, page 44
You disclose on page 45 that the significant increase in your Research and development
expenses was due to expenses incurred to conduct your clinical trials related to the
development of RAD101, RAD202 and RAD204, and expenses related to the clinical
programs developed by Radiopharm Ventures.  Given the 79% increase, please revise to
address the following regarding this increase in Research and development expenses:
•Disclose the extent to which you track Research and development expenses by
product candidate.  If you do not track any expenses by product candidate, disclose
that fact.  For amounts that are tracked by product candidate, revise to provide a
breakdown by product candidate.  2.

September 16, 2024
Page 2
•For any amounts that are not tracked by product candidate, provide a breakdown by
type or nature of expenses such that the total reconciles to the line item for each
period presented.
Item 6. Directors, Senior Management and Employees, page 51
3.Please revise the disclosure pertaining to Dimitris Voliotis to clearly indicate his business
experience for the past five years. In this regard, we note that you have not included
applicable dates or ranges from which investors can discern his principal occupations and
employment during such time period as you have for your other executives.
            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.
            Please contact Gary Newberry at 202-551-3761 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Alberto Pacchioni

CORRESP
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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.

    2

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

3

August 22, 2024
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Amendment No. 3 to Registration Statement on Form 20FR12B
Filed July 25, 2024
File No. 001-41621
Dear Riccardo Canevari:
            We have reviewed your filing and have the following comments.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response and any amendment you may file in response to this letter,
we may have additional comments.
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.

Our Licensed Platform Technologies, page 27
We note that in numerous places throughout this section, you disclose the potential timing 2.

August 22, 2024
Page 2
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.
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.
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.
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.
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.
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.
            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.
            Please contact Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at 202-551-3675 with any other
questions.

August 22, 2024
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Alberto Pacchioni

CORRESP
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April
14, 2023

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. 1 to Registration Statement on Form 20FR12B

Filed
March 20, 2023

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 March 31, 2023 with respect to Amendment No. 1 to the Company’s Registration
Statement on Form 20-F that was filed on March 20, 2023.

The
Company is concurrently filing Amendment No. 2 to its Registration Statement on Form 20-F, which includes changes made
in response to the Comments and certain other changes (the “Amendment No. 2”).

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. 2.

Amendment
No. 1 to Registration Statement on Form 20FR12B

RAD
Clinical Development Pipeline, page 26

 1. We
                                            note your response to prior comment two.  Your pipeline table should include material
                                            product candidates in development.  Given your lack of current plans to develop RAD201,
                                            it does not appear that it is appropriate to continue to include this product candidate in
                                            your pipeline table.  The facts that development could be resumed and the results
                                            of your Phase I trials supported your decision to pursue another candidate trial, which
                                            is depicted in the table, is not sufficient to continue to continue to include RAD201 in
                                            your pipeline table.

The
Company respectfully advises that it has revised the disclosure on page 26 accordingly.

Stock
Purchase Agreement with Pharma15 and its selling stockholders, page 70

 2. We
                                            note your disclosure regarding your recent acquisition of Pharma15 via a stock purchase agreement,
                                            the terms of which provide for post-closing contingent consideration of $3.2 million [sic]
                                            to Pharma15 selling stockholders which could be satisfied by the issuance of Radiopharm
                                            ordinary shares depending on the price of such shares at the time a grant occurs.
                                            Given your statement that you can issue up to 47,000,000 ordinary shares without shareholder
                                            approval to satisfy the contingent consideration under ASX listing rules, and that this
                                            number of shares appears to be material relative to the number of ordinary shares currently
                                            issued and outstanding, please include risk factor disclosure addressing dilution your
                                            shareholders may experience and the potential impact such additional issuance may have on
                                            the market price of your ordinary shares.

The
Company respectfully advises that it has revised the disclosure on page 16 accordingly.

Sublicense
Agreement with NeoIndicate, page 70

 3. Please
                                            disclose your obligation to pay an annual license maintenance fee and quantify the amount
                                            of the fee.

The
Company respectfully advises that it has revised the disclosure on page 70 accordingly.

Jurisdiction
and Arbitration, page 89

 4. We
                                            note your revisions in response to prior comment 9, which we reissue.  You now state
                                            both on page 89 and in your risk factor on page 20 that the arbitration provisions of
                                            the Deposit Agreement do not preclude ADS holders from pursuing claims under the Securities
                                            Act or the Exchange Act “in federal courts,” mirroring the third paragraph of
                                            Section 7.6 in the Deposit Agreement.  However, the fourth paragraph of Section
                                            7.6 states that ADS holders irrevocably agree that any legal suit, action or proceeding against
                                            or involving the Company or the Depositary may be instituted in a state or federal court
                                            in New York, New York.  Please revise exhibit 2.1 to eliminate this internal inconsistency
                                            by stating that the arbitration provisions will not preclude ADS holders from pursuing
                                            Securities Act or Exchange Act claims in state or federal courts, and make conforming
                                            changes to your prospectus disclosure.  In this regard, we note that Section 22
                                            of the Securities Act creates concurrent jurisdiction for federal and state courts over all
                                            suits brought to enforce any duty or liability created by the Securities Act or the rules
                                            and regulations thereunder.

Consistent
with prior conversation with the Staff, the Company respectfully advises that it has revised the disclosure on pages 20 and 87 of Amendment
2 and page 32 of Exhibit 2.1.

*          *          *          *          *

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

United States securities and exchange commission logo
March 31, 2023
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Amendment No. 1 to Registration Statement on Form 20FR12B
Filed March 20, 2023
File No. 001-41621
Dear Riccardo Canevari:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response and any amendment you may file in response to these
comments, we may have additional comments.
Amendment No. 1 to Registration Statement on Form 20FR12B
RAD Clinical Development Pipeline, page 26
1.We note your response to prior comment two.  Your pipeline table should include material
product candidates in development.  Given your lack of current plans to develop RAD201,
it does not appear that it is appropriate to continue to include this product candidate in
your pipeline table.  The facts that development could be resumed and the results of your
Phase I trials supported your decision to pursue another candidate trial, which is depicted
in the table, is not sufficient to continue to continue to include RAD201 in your pipeline
table.
Stock Purchase Agreement with Pharma15 and its selling stockholders, page 70
2.We note your disclosure regarding your recent acquisition of Pharma15 via a stock
purchase agreement, the terms of which provide for post-closing contingent consideration

 FirstName LastNameRiccardo  Canevari
 Comapany NameRadiopharm Theranostics Ltd
 March 31, 2023 Page 2
 FirstName LastName
Riccardo  Canevari
Radiopharm Theranostics Ltd
March 31, 2023
Page 2
of $3.2 million to Pharma15 selling stockholders which could be satisfied by the issuance
of Radiopharm ordinary shares depending on the price of such shares at the time a grant
occurs.  Given your statement that you can issue up to 47,000,000 ordinary shares without
shareholder approval to satisfy the contingent consideration under ASX listing rules, and
that this number of shares appears to be material relative to the number of ordinary shares
currently issued and outstanding, please include risk factor disclosure addressing dilution
your shareholders may experience and the potential impact such additional issuance may
have on the market price of your ordinary shares.
Sublicense Agreement with NeoIndicate, page 70
3.Please disclose your obligation to pay an annual license maintenance fee and quantify the
amount of the fee.
Jurisdiction and Arbitration, page 89
4.We note your revisions in response to prior comment 9, which we reissue.  You now state
both on page 89 and in your risk factor on page 20 that the arbitration provisions of the
Deposit Agreement do not preclude ADS holders from pursuing claims under the
Securities Act or the Exchange Act “in federal courts," mirroring the third paragraph of
Section 7.6 in the Deposit Agreement.  However, the fourth paragraph of Section 7.6
states that ADS holders irrevocably agree that any legal suit, action or proceeding against
or involving the Company or the Depositary may be instituted in a state or federal court in
New York, New York.  Please revise exhibit 2.1 to eliminate this internal inconsistency by
stating that the arbitration provisions will not preclude ADS holders from pursuing
Securities Act or Exchange Act claims in state or federal courts, and make conforming
changes to your prospectus disclsoure.  In this regard, we note that Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state courts over all suits
brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder.
            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.  You may contact Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-
551-3662 if you have questions regarding comments on the financial statements and related
matters.  Please contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at 202-551-3675 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Alberto Pacchioni

CORRESP
1
filename1.htm

March
20, 2023

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

Registration
Statement on Form 20FR12B

Filed
February 13, 2023

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 March 1, 2023 with respect to the Company’s Registration Statement on Form 20-F
that was filed on February 13, 2023.

The
Company is concurrently publicly filing Amendment No. 1 to its Registration Statement on Form 20-F, which includes changes
made in response to the Comments and certain other changes (the “Amended Registration Statement”).

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
the Amended Registration Statement.

Registration
Statement on Form 20FR12B Filed February 13, 2023

Risk
Factors

We
have a limited operating history and a history of losses . . ., page 4

1. We
                                       note your response to prior comment 4, which we reissue in part.  Please revise both the
                                       heading and narrative disclosure in this risk factor to expressly state that your independent
                                       auditor included a going concern opinion in its audit report raising substantial doubt
                                       about the Group’s ability to continue as a going concern.

The
Company respectfully advises that it has revised the disclosure on page 4.

Clinical
Approach

RAD
Clinical Development Pipeline, page 26

2. In
                                            light of your disclosure on page 32 that you no longer intend to further develop RAD201,
                                            please tell us whether, and if so how, the RAD201 program is sufficiently material to
                                            your business to warrant its continued inclusion in the pipeline table.  To the extent
                                            RAD201 remains in your pipeline table, please revise the notes column to explain that
                                            you have ceased development of this candidate, if accurate.

The
Company respectfully advises that it has revised the disclosure on pages 26 and 32. RAD201 should still be included in the pipeline table
because, as discussed in the revised disclosure, its development could be resumed and the results of its Phase I supported the Company’s
decision to start the RAD202 trial.

ITEM
4. INFORMATION ON THE COMPANY

Our
Licensed Platform Technologies

Nano-mAbs,
page 29

3. We
                                       note your revised disclsoure stating that you plan to seek IND approval from the FDA in 2023 to
                                       start a Phase 1 trial with RAD201 and RAD202.  This statement appears to be inconsistent
                                       with disclsoure on page 32 indicating that you do not currently intend to further develop RAD201.
                                       Please reconcile or advise.

The
Company respectfully advises that it has revised the disclosure on pages 29 and 32.

Our
Drug Candidates

RAD201
(Nano-mAb HER-2 Breast Diagnostic) and RAD202 (Nano-mAb Her-2 Breast Therapeutic), page 31

4. Please
                                       further revise your disclsoure in this section to explain when and why the Company decided not
                                       to further develop the RAD201 product candidate.

The
Company respectfully advises that it has revised the disclosure on page 32.

RAD502
(DUNP-19 Osteosarcoma), page 33

5. We
                                       note your response to prior comment 20, and we have the following additional comment.

 ● Please
                                            further revise your disclosure to clarify that FDA Orphan Drug Designation does not
                                            eliminate any FDA regulatory requirements or guarantee a shortened regulatory review process
                                            or FDA approval.

 ● Please
                                            briefly explain the conditions for and the impact of receiving a FDA Priority Review Voucher
                                            at the time a marketing authorization may be granted.

The
Company respectfully advises that it has revised the disclosure on page 34.

Corporate
Governance Requirements under NASDAQ listing rules, page 58

6. Please
                                       expand your disclosure to clearly state whether proxies are counted in show of hands voting.
                                       If there are any circumstances in which proxies are not counted, please explain those circumstances
                                       and expand your risk factor discussion on page 22 to describe the circumstances under which proxies
                                       will not be counted.

The
Company respectfully advises that it has revised the disclosure on pages 22 and 59.

    2

ITEM
10. ADDITIONAL INFORMATION

C.
Material Contracts, page 68

7. We
                                       note your response to prior comment 28, which we reissue with respect to the license agreement
                                       with Diaprost AB and Fredax AB. Please revise to state the expected expiration date
                                       of the last-to-expire patent right under that agreement.  Additionally, please revise
                                       your discussion of the license agreement with The Regents of the University of California to state
                                       the expected expiration date of the last-to-expire patent right under that agreement.

The
Company respectfully advises that it has revised the disclosure on pages 69 and 70.

Jurisdiction
and Arbitration, page 86

8. Since
                                       you state that the exclusive jurisdiction provision under the Deposit Agreement will apply
                                       to claims under the Securities Act and the Exchange Act, please revise your disclosure to
                                       state that there is uncertainty as to whether a court would enforce such provision. Since the
                                       provision applies to Securities Act claims, please also state that investors cannot
                                       waive compliance with the federal securities laws and the rules and regulations thereunder. In
                                       that regard, we note that Section 22 of the Securities Act creates concurrent jurisdiction for
                                       federal and state courts over all suits brought to enforce any duty or liability created by the
                                       Securities Act or the rules and regulations thereunder.

Additionally,
please revise Exhibit 2.1 to clarify how the jurisdiction provision applies to claims under the Securities Act and the Exchange Act or
confirm that you will make future investors aware of the provision’s applicability by providing disclosure in future Exchange Act reports.

The
Company respectfully advises that it has revised the disclosure on pages 20 and 87.

The
Company confirms that the Company will make future investors aware of the Jurisdiction and Arbitration provision included in the Deposit
Agreement by providing disclosure in future Exchange Act reports.

9. You
                                       state both on page 86 and in your risk factor on page 20 that the arbitration provisions
                                       of the deposit agreement do not preclude ADS holders from pursuing claims under the Securities
                                       Act or the Exchange Act “in federal or state courts,” while the third paragraph
                                       of Section 7.6 in the Deposit Agreement indicates that the arbitration provisions do not preclude
                                       ADS holders from pursuing claims “in federal courts.”  Please reconcile your disclosure
                                       in Exhibit 2.1 to eliminate this inconsistency.

The
Company respectfully advises that it has revised the disclosure on page 20 and 87.

*          *          *          *          *

    3

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

4

United States securities and exchange commission logo
March 1, 2023
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Registration Statement on Form 20FR12B
Filed February 13, 2023
File No. 001-41621
Dear Riccardo Canevari:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response and any amendment you may file in response to these
comments, we may have additional comments.
Registration Statement on Form 20FR12B Filed February 13, 2023
Risk Factors
We have a limited operating history and a history of losses . . ., page 4
1.We note your response to prior comment 4, which we reissue in part.  Please revise both
the heading and narrative disclosure in this risk factor to expressly state that your
independent auditor included a going concern opinion in its audit report raising substantial
doubt about the Group’s ability to continue as a going concern.
Clinical Approach
RAD Clinical Development Pipeline, page 26
2.In light of your disclosure on page 32 that you no longer intend to further develop
RAD201, please tell us whether, and if so how, the RAD201 program is sufficiently
material to your business to warrant its continued inclusion in the pipeline table.  To the

 FirstName LastNameRiccardo  Canevari
 Comapany NameRadiopharm Theranostics Ltd
 March 1, 2023 Page 2
 FirstName LastNameRiccardo  Canevari
Radiopharm Theranostics Ltd
March 1, 2023
Page 2
extent RAD201 remains in your pipeline table, please revise the notes column to
explain that you have ceased development of this candidate, if accurate.
ITEM 4. INFORMATION ON THE COMPANY
Our Licensed Platform Technologies
Nano-mAbs, page 29
3.We note your revised disclsoure stating that you plan to seek IND approval from the FDA
in 2023 to start a Phase 1 trial with RAD201 and RAD202.  This statement appears to be
inconsistent with disclsoure on page 32 indicating that you do not currently intend to
further develop RAD201.  Please reconcile or advise.
Our Drug Candidates
RAD201 (Nano-mAb HER-2 Breast Diagnostic) and RAD202 (Nano-mAb Her-2 Breast
Therapeutic), page 31
4.Please further revise your disclsoure in this section to explain when and why the Company
decided not to further develop the RAD201 product candidate.

RAD502 (DUNP-19 Osteosarcoma), page 33
5.We note your response to prior comment 20, and we have the following additional
comment.
•Please further revise your disclosure to clarify that FDA Orphan Drug Designation
does not eliminate any FDA regulatory requirements or guarantee a shortened
regulatory review process or FDA approval.
•Please briefly explain the conditions for and the impact of receiving a FDA Priority
Review Voucher at the time a marketing authorization may be granted.
Corporate Governance Requirements under NASDAQ listing rules, page 58
6.Please expand your disclosure to clearly state whether proxies are counted in show of
hands voting.  If there are any circumstances in which proxies are not counted, please
explain those circumstances and expand your risk factor discussion on page 22 to describe
the circumstances under which proxies will not be counted.
ITEM 10. ADDITIONAL INFORMATION
C. Material Contracts, page 68
7.We note your response to prior comment 28, which we reissue with respect to the license
agreement with Diaprost AB and Fredax AB. Please revise to state the expected
expiration date of the last-to-expire patent right under that agreement.  Additionally,
please revise your discussion of the license agreement with The Regents of the University
of California to state the expected expiration date of the last-to-expire patent right under
that agreement.

 FirstName LastNameRiccardo  Canevari
 Comapany NameRadiopharm Theranostics Ltd
 March 1, 2023 Page 3
 FirstName LastName
Riccardo  Canevari
Radiopharm Theranostics Ltd
March 1, 2023
Page 3
Jurisdiction and Arbitration, page 86
8.Since you state that the exclusive jurisdiction provision under the Deposit Agreement will
apply to claims under the Securities Act and the Exchange Act, please revise your
disclosure to state that there is uncertainty as to whether a court would enforce such
provision. Since the provision applies to Securities Act claims, please also state that
investors cannot waive compliance with the federal securities laws and the rules and
regulations thereunder. In that regard, we note that Section 22 of the Securities Act creates
concurrent jurisdiction for federal and state courts over all suits brought to enforce any
duty or liability created by the Securities Act or the rules and regulations thereunder.

Additionally, please revise Exhibit 2.1 to clarify how the jurisdiction provision applies to
claims under the Securities Act and the Exchange Act or confirm that you will make
future investors aware of the provision's applicability by providing disclosure in future
Exchange Act reports.

9.You state both on page 86 and in your risk factor on page 20 that the arbitration provisions
of the deposit agreement do not preclude ADS holders from pursuing claims under the
Securities Act or the Exchange Act "in federal or state courts,"  while the third paragraph
of section Section 7.6 in the Deposit Agreement indicates that the arbitration provisions
do not preclude ADS holders from pursuing claims"in federal courts."  Please reconcile
your disclosure in Exhibit 2.1 to eliminate this inconsistency.
            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.
            You may contact Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Alberto Pacchioni

CORRESP
1
filename1.htm

February
13, 2023

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 Ltd

                                            Draft Registration Statement on Form 20-F

                                            Filing date: December 16, 2022

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 January 13, 2023 with respect to the Company’s Draft Registration Statement on
Form 20-F that was filed on December 16, 2022. The Company is concurrently publicly filing its Registration Statement on Form 20-F, which
includes changes made in response to the Comments and certain other changes (the “Registration Statement”).

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
the Registration Statement.

Draft
Registration Statement on Form 20-F Submitted December 16, 2022

ITEM
3. KEY INFORMATION, page -

 1. Remove
                                            statements indicting that your product candidates are safe or effective, including statements
                                            that imply safety or efficacy, such as those describing your candidates or their mechanisms
                                            of action as “promising” or “very promising,” and referring to their
                                            “noteworthy performance” or “encouraging” data or results.  Make
                                            similar revisions throughout your registration statement.  Conclusions regarding the
                                            safety or efficacy of your drug candidates are solely within the authority of the FDA and
                                            comparable regulatory bodies. With respect to safety, we will not object to statements that
                                            your drug candidates were well-tolerated, if true, or that no serious adverse events deemed
                                            to be study related were reported.  You may also present a balanced summary of
                                            the objective pre-clinical and clinical data, including whether clinical trials trial
                                            met primary and secondary endpoints without including your conclusions related to efficacy.

The
Company respectfully advises that it has updated the disclosure throughout the Registration Statement  in accordance with this Comment.

D.
Risk Factors, page 1

 2. Please
                                            describe in an appropriate risk factor the risks related to your quorum requirements
                                            and voting on a show of hands. Additionally, expand the disclosure on pages 18, 58 and 65
                                            to describe the distinction between poll voting and voting on a show of hands.

The
Company respectfully advises that it has updated the disclosure on pages 18, 22, 58 and 65.

ITEM
6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES, page -

 3. We
                                            note your statement that you develop your products and therapies in conjunction with a medical
                                            advisory board.  If material, please include disclosure in an appropriate place that:

 ● Describes
the role or function of your medical advisory board; and

 ● Describes
the composition of such board.

The
Company respectfully advises that it has updated the disclosure on page 51.

We
have a limited operating history and a history of losses . . ., page 4

 4. Please
                                            revise the heading and narrative disclosure in this risk factor to expressly highlight the
                                            explanatory paragraph in the audit opinion raising substantial doubt about the Group’s
                                            ability to continue as a going concern. Also, disclose the potential effect it may have
                                            on your ability to raise additional funds through equity or debt financing.

The
Company respectfully advises that it has updated the disclosure on page 4.

ADSs
holders may not be entitled to a jury trial . . ., page 19

 5. We
                                            note that the deposit agreement to be filed as Exhibit 2.1 contains a jury trial waiver
                                            provision. Please augment your risk factor disclosure as follows:

 ● Expressly
disclose that this provision applies to any claim under the U.S. federal securities laws, as you have on page 86.  Also revise
the disclosure on page 86 to state that, by agreeing to such provision, investors will not be deemed to have waived the Company’s
compliance with the federal securities laws and the rules and regulations thereunder.

 ● Highlight
the risk that the provision may limit access to information and lead to other imbalances of resources between the Company and
shareholders, and that the provision may limit shareholders’ ability to bring a claim in a judicial forum that they find
favorable.

The
Company respectfully advises that it has updated the disclosure on pages 19 and 86.

B.
Business Overview

Strategy,
page 24

 6. You
                                            state on page 24 that your clinical assets have the potential to be “First to Market”
                                            in specific indications or “Best in Class” compared to other molecules already
                                            in development.  You also make references throughout to DUNP19 as a “first-in-class”
                                            small antibody and to RAD601’s potential to be a “first in class therapy,” and imply
                                            an expectation of regulatory approval when making statements such as the following on
                                            page 25:   “Once we receive FDA approval for our drug candidates, we will
                                            be able to commercialize our drug candidates in the United States . . .”  Given
                                            the development stage of your candidates and the length and uncertainty of the regulatory approval
                                            process, it is premature and speculative to state or imply that any of your products will
                                            ultimately be approved or become best-in-class or first-in-class.  Please remove these
                                            statements.

The
Company respectfully advises that it has updated the disclosure throughout the Registration Statement in accordance with this Comment.

    2

 7. Your
                                            disclosure that the July 2021 exclusive license agreement with NanoMab Technologies included
                                            an agreement to pay upfront license fees of US$1,500,000 in cash and US$9,500,000 in ordinary
                                            shares appears inconsistent with the disclosure on page 67 indicating that the July 2021
                                            agreement required an upfront payment of US$12.5 million. Please revise your disclosure accordingly.

The
Company respectfully advises that it has updated the disclosure on page 23.

 8. On
                                            page 25, you state your belief that your product candidates may qualify for one or more FDA
                                            expedited review programs.  In this regard:

 ● In
an appropriate place in your Business discussion, disclose which of your product candidates you believe may qualify for such programs
and explain why.

 ● Please
balance your disclosure here and elsewhere as appropriate by clarifying that because your candidates are in early development, there
can be no assurance that the FDA will approve any form of application for expedited review for any of your product candidates.

 ● Affirmatively
state that the FDA’s accelerated approval pathways do not guarantee an accelerated review by the FDA. Further, explain that even
if a product candidate could be granted a designation or qualify for expedited development, it does not increase the likelihood that
the product candidate will receive approval.

The
Company respectfully advises that it has updated page 25 by deleting from the disclosure of its strategy that the Company intends to
take advantage of expedited review programs.

Clinical
Approach, page 25

 9. It
                                            appears that part of your business strategy is to perform preclinical studies and clinical
                                            trials in various countries to generate data to be used first to seek FDA approval in the
                                            United States before seeking approval in other jurisdictions.

 ● For
each of your product candidates, please disclose the location of completed, ongoing, and planned preclinical and clinical trials.
Balance your discussion by clarifying that the clinical data discussed may not be accepted by the FDA or comparable foreign regulatory
authorities and if so, may result in the need to conduct additional trials.

 ● Make
similar conforming changes to your risk factor disclosure in the fifth bullet point on page 4 to highlight that certain of your completed,
ongoing, and planned clinical trials have been conducted outside the U.S.

The
Company respectfully advises that it has updated the disclosure on pages 4, 31, 32, 33 and 34.

Market
Opportunity, page 26

 10. Please
                                            balance your statement that the global market size your are targeting is US$6 billion
                                            by disclosing here that you do not have any products approved for commercial sale and discussing
                                            the regulatory steps you must take before receiving such approvals.

The
Company respectfully advises that it has updated the disclosure on page 26.

    3

RAD
Clinical Development Pipeline, page 26

 11. With
                                            respect to your pipeline table on page 26:

 ● Please
revise to indicate what the information presented in the “Country” and “DX/TX” columns is intended to convey.
Also, explain why there is no country indicated in the rows for RAD 601 and 602.

 ● Revise
to indicate the sponsor of the trials reflected for each candidate.

The
Company respectfully advises that it has updated the table and the disclosure on page 26.

 12. Please
                                            explain the acronyms ODD and RPDD in the Notes to the pipeline table or in a footnote to
                                            the table.

The
Company respectfully advises that it has updated the table and the disclosure on page 26.

Our
Licensed Platform Technologies, page 28

 13. In
                                            numerous places throughout the Business section, you disclose the potential timing of planned
                                            Phase 1 clinical trials for certain preclinical candidates without addressing whether you
                                            have sought regulatory approval to commence such trials.

 ● Please
revise where appropriate to clarify if you have submitted an IND or foreign equivalent and if so, whether you have received approval
from the FDA or a comparable foreign regulator for RAD202, RAD204, RAD501, RAD502, RAD601 and RAD602.  If not, revise to state when
you plan to do so.

 ● Additionally,
please revise your clinical trial descriptions to disclose the specific program/product candidate to be investigated in your planned
trials.  For example, you reference a planned Phase 1 trial of DUNP19 in osteosarcoma, but do not indicate whether the trial will
involve RAD501, RAD502, or both.

The
Company respectfully advises that it has updated the disclosure on pages 29 and 30.

 14. Please
                                            provide support for your claim that you have one of the deepest pipelines of radiopharmaceutical
                                            therapies or delete the claim from your registration statement.

The
Company respectfully advises that it has deleted the table on page 28.

 15. Please
                                            explain the significance of the logos included at the bottom of the table on page 28. To
                                            the extent that you have entered into licensing or commercialization agreements with any
                                            of the parties represented by the logos, please ensure that the terms of the agreements are
                                            described and the agreements are filed as exhibits.  If you believe the agreements are
                                            not required to be filed as exhibits, please provide an analysis supporting your conclusion.
                                             Additionally, in some instances the logos are illegible.  Please ensure that the
                                            references are sufficiently clear so that they can be read.

The
Company respectfully advises that it has deleted the table on page 28.

 16. Please
                                            revise your graphics on page 32 and any others throughout your filing to ensure that
                                            the text in each, including subscript or other notations, are clearly legible.

The
Company respectfully advises that it has deleted the table on pages 32, 33 and 34.

 17. With
                                            respect to your description of Privalate on page 29, you have indicated that Privalate showed
                                            superior imaging performance in prostate and brain cancers and equally good performance in
                                            breast cancer models.  Please refrain from indicating that technology that is not FDA
                                            approved is effective or superior to technologies that are approved.  You may present
                                            objective result of clinical trials but such results should not be compared to alternative
                                            technologies unless head to head studies were conducted.  With respect to your Privalate
                                            trials appearing on page 31 remove your statement that the F-FPIA has been shown to be safe
                                            and that it showed superior quality of imaging performance.  If accurate, you may indicate
                                            that there were no participants that experienced serious adverse events along with an objective
                                            description of the results.  If a statistical analysis was performed, disclose the p
                                            values.

The
Company respectfully advises that it has updated the disclosure on pages 29 and 31.

    4

Our
Drug Candidates, page 31

 18. With

United States securities and exchange commission logo
January 13, 2023
Riccardo Canevari
Chief Executive Officer
Radiopharm Theranostics Ltd
Level 3, 62 Lygon Street, Carlton VIC 3053
Australia
Re:Radiopharm Theranostics Ltd
Draft Registration Statement on Form 20-F
Submitted December 16, 2022
CIK No. 0001949257
Dear Riccardo Canevari:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form 20-F Submitted December 16, 2022
ITEM 3. KEY INFORMATION, page -
1.Remove statements indicting that your product candidates are safe or effective,
including statements that imply safety or efficacy, such as those describing your
candidates or their mechanisms of action as "promising" or "very promising," and
referring to their "noteworthy performance" or "encouraging" data or results.  Make
similar revisions throughout your registration statement.  Conclusions regarding the safety
or efficacy of your drug candidates are solely within the authority of the FDA and
comparable regulatory bodies. With respect to safety, we will not object to statements that
your drug candidates were well-tolerated, if true, or that no serious adverse events deemed
to be study related were reported.  You may also present a balanced summary of the

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objective pre-clinical and clinical data, including whether clinical trials trial met primary
and secondary endpoints without including your conclusions related to efficacy.
D. Risk Factors , page 1
2.Please describe in an appropriate risk factor the risks related to your quorum requirements
and voting on a show of hands. Additionally, expand the disclosure on pages 18, 58 and
65 to describe the distinction between poll voting and voting on a show of hands.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES, page -
3.We note your statement that you develop your products and therapies in conjunction with
a medical advisory board.  If material, please include disclosure in an appropriate place
that:
•Describes the role or function of your medical advisory board; and
•Describes the composition of such board.
We have a limited operating history and a history of losses . . ., page 4
4.Please revise the heading and narrative disclosure in this risk factor to expressly highlight
the explanatory paragraph in the audit opinion raising substantial doubt about the Group’s
ability to continue as a going concern. Also, disclose the potential effect it may have on
your ability to raise additional funds through equity or debt financing.
ADSs holders may not be entitled to a jury trial . . ., page 19
5.We note that the deposit agreement to be filed as Exhibit 2.1 contains a jury trial waiver
provision. Please augment your risk factor disclosure as follows:
•Expressly disclose that this provision applies to any claim under the U.S. federal
securities laws, as you have on page 86.  Also revise the disclosure on page 86 to
state that, by agreeing to such provision, investors will not be deemed to have waived
the Company's compliance with the federal securities laws and the rules and
regulations thereunder.
•Highlight the risk that the provision may limit access to information and lead to other
imbalances of resources between the Company and shareholders, and that
the provision may limit shareholders' ability to bring a claim in a judicial forum that
they find favorable.
B. Business Overview
Strategy, page 24
6.You state on page 24 that your clinical assets have the potential to be "First to Market" in
specific indications or "Best in Class" compared to other molecules already in
development.  You also make references throughout to DUNP19 as a "first-in-class" small
antibody and to RAD601's potential to be a "first in class therapy," and imply an
expectation of regulatory approval when making statements such as the following on page

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25:   "Once we receive FDA approval for our drug candidates, we will be able to
commercialize our drug candidates in the United States . . ."  Given the development stage
of your candidates and the length and uncertainty of the regulatory approval process, it is
premature and speculative to state or imply that any of your products will ultimately be
approved or become best-in-class or first-in-class.  Please remove these statements.
7.Your disclosure that the July 2021 exclusive license agreement with NanoMab
Technologies included an agreement to pay upfront license fees of US$1,500,000 in cash
and US$9,500,000 in ordinary shares appears inconsistent with the disclosure on page 67
indicating that the July 2021 agreement required an upfront payment of US$12.5 million.
Please revise your disclosure accordingly.
8.On page 25, you state your belief that your product candidates may qualify for one or
more FDA expedited review programs.  In this regard:
•In an appropriate place in your Business discussion, disclose which of your product
candidates you believe may qualify for such programs and explain why.
•Please balance your disclosure here and elsewhere as appropriate by clarifying that
because your candidates are in early development, there can be no assurance that the
FDA will approve any form of application for expedited review for any of your
product candidates.
•Affirmatively state that the FDA’s accelerated approval pathways do not guarantee an
accelerated review by the FDA. Further, explain that even if a product candidate
could be granted a designation or qualify for expedited development, it does not
increase the likelihood that the product candidate will receive approval.
Clinical Approach, page 25
9.It appears that part of your business strategy is to perform preclinical studies and clinical
trials in various countries to generate data to be used first to seek FDA approval in the
United States before seeking approval in other jurisdictions.
•For each of your product candidates, please disclose the location of completed,
ongoing, and planned preclinical and clinical trials. Balance your discussion by
clarifying that the clinical data discussed may not be accepted by the FDA or
comparable foreign regulatory authorities and if so, may result in the need to conduct
additional trials.
•Make similar conforming changes to your risk factor disclosure in the fifth bullet
point on page 4 to highlight that certain of your completed, ongoing, and
planned clinical trials have been conducted outside the U.S.
Market Opportunity, page 26
10.Please balance your statement that the global market size your are targeting is US$6
billion by disclosing here that you do not have any products approved for commercial sale
and discussing the regulatory steps you must take before receiving such approvals.
RAD Clinical Development Pipeline, page 26

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11.With respect to your pipeline table on page 26:
•Please revise to indicate what the information presented in the "Country" and
"DX/TX" columns is intended to convey.  Also, explain why there is no country
indicated in the rows for RAD 601 and 602.
•Revise to indicate the sponsor of the trials reflected for each candidate.
12.Please explain the acronyms ODD and RPDD in the Notes to the pipeline table or in a
footnote to the table.
Our Licensed Platform Technologies, page 28
13.In numerous places throughout the Business section, you disclose the potential timing of
planned Phase 1 clinical trials for certain preclinical candidates without addressing
whether you have sought regulatory approval to commence such trials.
•Please revise where appropriate to clarify if you have submitted an IND or foreign
equivalent and if so, whether you have received approval from the FDA or a
comparable foreign regulator for RAD202, RAD204, RAD501, RAD502, RAD601
and RAD602.  If not, revise to state when you plan to do so.
•Additionally, please revise your clinical trial descriptions to disclose the specific
program/product candidate to be investigated in your planned trials.  For example,
you reference a planned Phase 1 trial of DUNP19 in osteosarcoma, but do not
indicate whether the trial will involve RAD501, RAD502, or both.
14.Please provide support for your claim that you have one of the deepest pipelines of
radiopharmaceutical therapies or delete the claim from your registration statement.
15.Please explain the significance of the logos included at the bottom of the table on page
28.  To the extent that you have entered into licensing or commercialization agreements
with any of the parties represented by the logos, please ensure that the terms of the
agreements are described and the agreements are filed as exhibits.  If you believe the
agreements are not required to be filed as exhibits, please provide an analysis supporting
your conclusion.   Additionally, in some instances the logos are illegible.  Please ensure
that the references are sufficiently clear so that they can be read.
16.Please revise your graphics on page 32 and any others throughout your filing to ensure
that the text in each, including subscript or other notations, are clearly legible.
17.With respect to your description of Privalate on page 29, you have indicated that Privalate
showed superior imaging performance in prostate and brain cancers and equally good
performance in breast cancer models.  Please refrain from indicating that technology that
is not FDA approved is effective or superior to technologies that are approved.  You may
present objective result of clinical trials but such results should not be compared to
alternative technologies unless head to head studies were conducted.  With respect to your
Privalate trials appearing on page 31 remove your statement that the F-FPIA has been
shown to be safe and that it showed superior quality of imaging performance.  If accurate,

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you may indicate that there were no participants that experienced serious adverse events
along with an objective description of the results.  If a statistical analysis was performed,
disclose the p values.
Our Drug Candidates, page 31
18.With respect to all completed clinical trials discussed in this section, please revise your
disclosure to provide results in proper context for such results. For each completed clinical
trial, please disclose the number of subjects participating in the trial, the primary and
secondary end points, the results observed relative to the endpoints, and whether statistical
significance was demonstrated, including supporting p-values.  Additionally, disclose
where the trials were conducted and any serious adverse events.

RAD203 (Nano-mAb PDL1 Non-small Cell Lung Diagnostic) and RAD204 (Nano-mAb PDL1
Non-small Cell Lung Cancer Therapeutic), page 32
19.We note that you licensed RAD203 to Lantheus Molecular Imaging.  Please clarify what
rights you have retained in the product candidate.
RAD501 and RAD502 (DUNP-19 Osteosarcoma), page 33
20.Please revise to briefly describe the significance of having obtained Orphan Drug
Designation and Pediatric Rare Disease Designation for DUNP19 in osteosarcoma.
Competition, page 36
21.It is unclear how the table on page 36 demonstrates competing products' "associated
pitfalls for patients." Please remove this phrase from the narrative preceding the table or
revise.
Patent Portfolio, page 36
22.Please revise the patent portfolio table on page 36 as follows:
•Describe the type of patent protection granted for each product or technology
(composition of matter, use, or process).
•With respect to the final two rows of the table for DUNP19 and PTP, please revise
the Details column to disclose the status of your patents as you have for patents
related to your other clinical assets.
FDA Process, page 37
23.Please expand your discussion to address how the pediatric drug approval process differs
from the FDA approval process described.
Manufacturing and Raw Materials, page 45
24.Please revise to provide a description of the sources and availability of raw materials,

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including a description of whether prices of principal raw materials are volatile.  Refer to
Item 4.B.4 of Form 20-F.
Operating and Financial Review and Prospects
Comparison of fiscal year ended June 30, 2022 to June 30, 2021, page 46
25.Revise your tabular summary of results of operations to present income tax expense.
Your current presentation implies that the various line items all sum to equal total
comprehensive loss, which is not true as income tax expense is excluded.
B. Liquidity and Capital Resources, page 48
26.We note the disclosure of liabilities contingent on future events in respect of the various
license agreements in Footnote 12 on page F-25.  Please provide a discussion and analysis
of any material events and uncertainties known to management regarding these contingent
milestones that would cause reported financial information not to be necessarily indicative
of future operating results or of future financial condition.  Refer to Part I, Item 5 of Form
20-F and Instruction 7 to Item 5.
Executive Compensation, page 53
27.Please clarify the nature of the remuneration disclosed with respect to each individual in
the "Other" column of the compensation table.
ITEM 10. ADDITIONAL INFORMATION
C. Material Contracts, page 67
28. With respect to the discussion of each of your license and sublicense agreements:
•Please revise your description of the duration of each agreement by disclosing the
expected expiry of the last-to-expire patent licensed under the agreements.
•Revise to disclose the applicable royalty rate under each agreement. In the event a
range is provided in place of the actual royalty rate, such range should be within ten
percentage points.
•Revise page 68 to include a summary description of any royalty payments and
sublicensing fees under the license agreement with Diaprost and Fredax.  In this
regard, we note you disclose on page 23 that you have agreed to pay net sales-based
royalty payments and sublicensing fees under that agreement, but do not discuss these
payments and fees here.

29.Throughout the Form 20-F, you refer to various agreements with related or third parties
that you have not discussed as material contracts or included as exhibits, including the
following:
•Service Research Agreement with the Imperial College of London related to
RAD102;
•Outlicense agreement with Lantheus Molecular Imaging granting worldwide rights to

 FirstName LastNameRiccardo  Canevari
 Comapany NameRadi