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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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January 13, 2023
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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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Radiopharm Theranostics Ltd
January 13, 2023
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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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January 13, 2023
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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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January 13, 2023
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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