Correspondence 0001213900-23-010451 from Radiopharm Theranostics Ltd (RADX, RDPTF) (CIK 0001949257) (RADX)
Radiopharm Theranostics Ltd (RADX, RDPTF) (CIK 0001949257)
Date: Feb. 13, 2023 · CIK: 0001949257 · Accession: 0001213900-23-010451
AI Filing Summary & Sentiment
Referenced dates: January 13, 2023
Letter
February 13, 2023
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
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.
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.
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.
Our Drug Candidates, page 31
18. With
Show Raw Text
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