# EDGAR Filing Document

**Accession Number:** 0001949257
**File Stem:** 0000000000-23-002084
**Filing Date:** 2023-3
**Character Count:** 15164
**Document Hash:** 1b818ad5ad488e74cf9eb2ea59c9efe2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-23-002084.hdr.sgml**: 20241227

**ACCESSION NUMBER**: 0000000000-23-002084

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230301

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Radiopharm Theranostics Ltd
- **CENTRAL INDEX KEY:** 0001949257
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** C3
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** UPLOAD
- **SEC FILE NUMBER:** 377-06505

**BUSINESS ADDRESS:**
- **STREET 1:** LEVEL 3, 62 LYGON STREET
- **CITY:** CARLTON VIC
- **STATE:** C3
- **ZIP:** 3053
- **BUSINESS PHONE:** 61 3 9824 5254

**MAIL ADDRESS:**
- **STREET 1:** LEVEL 3, 62 LYGON STREET
- **CITY:** CARLTON VIC
- **STATE:** C3
- **ZIP:** 3053
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001213900-22-080267

## Text-Extract

```

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
 Riccardo Canevari
FirstName
RadiopharmLastNameRiccardo
             Theranostics Ltd Canevari
Comapany
March      NameRadiopharm Theranostics Ltd
       1, 2023
March2 1, 2023 Page 2
Page
FirstName LastName
         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.
 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,
FirstName LastNameRiccardo Canevari
                                                             Division of
Corporation Finance
Comapany NameRadiopharm Theranostics Ltd
                                                             Office of Life
Sciences
March 1, 2023 Page 3
cc:       Alberto Pacchioni
FirstName LastName

```

### Attached PDF Documents

**Attachment 1:** `filename1`

![img-0.jpeg](img-0.jpeg)

CORPORATION FINANCE

# UNITED STATES  
SECURITIES AND EXCHANGE COMMISSION  
WASHINGTON, D.C. 20549

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

Riccardo 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 disclosure 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 disclosure 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 disclosure 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.

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

cc: Alberto Pacchioni