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XORTX Therapeutics Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
XORTX Therapeutics Inc.
Awaiting Response
0 company response(s)
High
XORTX Therapeutics Inc.
Response Received
1 company response(s)
High - file number match
↓
XORTX Therapeutics Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-01-31
XORTX Therapeutics Inc.
Filing - SEC Comment Letter to XORTX Therapeutics Inc.
UPLOAD · 2023-01-31
Generating summary...
↓
XORTX Therapeutics Inc.
Response Received
8 company response(s)
Medium - date proximity
SEC wrote to company
2022-08-16
XORTX Therapeutics Inc.
Filing - SEC Comment Letter to XORTX Therapeutics Inc.
UPLOAD · 2022-08-16
Generating summary...
↓
Company responded
2022-09-08
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-08
Generating summary...
↓
Company responded
2022-09-08
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-08
Generating summary...
↓
Company responded
2022-09-14
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-14
Generating summary...
↓
Company responded
2022-09-19
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-19
Generating summary...
↓
Company responded
2022-09-19
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-19
Generating summary...
↓
Company responded
2022-09-21
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-21
Generating summary...
↓
Company responded
2022-09-22
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-22
Generating summary...
↓
Company responded
2022-09-22
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2022-09-22
Generating summary...
XORTX Therapeutics Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2021-09-01
XORTX Therapeutics Inc.
Filing - SEC Comment Letter to XORTX Therapeutics Inc.
UPLOAD · 2021-09-01
Generating summary...
↓
Company responded
2021-09-16
XORTX Therapeutics Inc.
References: September 1, 2021
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2021-09-16
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↓
Company responded
2021-10-08
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2021-10-08
Generating summary...
↓
Company responded
2021-10-08
XORTX Therapeutics Inc.
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2021-10-08
Generating summary...
XORTX Therapeutics Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-08-02
XORTX Therapeutics Inc.
Filing - SEC Comment Letter to XORTX Therapeutics Inc.
UPLOAD · 2021-08-02
Generating summary...
↓
Company responded
2021-08-11
XORTX Therapeutics Inc.
References: August 2, 2021
Filing - Correspondence from XORTX Therapeutics Inc.
CORRESP · 2021-08-11
Generating summary...
XORTX Therapeutics Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-06-28
XORTX Therapeutics Inc.
Filing - SEC Comment Letter to XORTX Therapeutics Inc.
UPLOAD · 2021-06-28
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-12 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-08-05 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | 377-08272 | Read Filing View |
| 2024-11-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-11-20 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | 333-283275 | Read Filing View |
| 2023-02-01 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2023-01-31 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-21 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-19 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-19 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-14 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-16 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-10-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-10-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-09-16 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-09-01 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-08-11 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-08-02 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-28 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-05 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | 377-08272 | Read Filing View |
| 2024-11-20 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | 333-283275 | Read Filing View |
| 2023-01-31 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-16 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-09-01 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-08-02 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-28 | SEC Comment Letter | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-12 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-11-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2023-02-01 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-22 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-21 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-19 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-19 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-14 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-09-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-10-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-10-08 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-09-16 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2021-08-11 | Company Response | XORTX Therapeutics Inc. | British Columbia, Canada | N/A | Read Filing View |
2026-02-12 - CORRESP - XORTX Therapeutics Inc.
CORRESP 1 filename1.htm XORTX THERAPEUTICS INC. 3710 – 33rd Street NW Calgary, Alberta, T2L 2M1 Canada VIA EDGAR February 12, 2026 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: XORTX THERAPEUTICS INC. Registration Statement on Form F-1 (File No. 333-290512) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, XORTX Therapeutics Inc., Inc. (the "Company") hereby requests that the Securities and Exchange Commission (the "Commission") accelerate the effective date of the above-referenced Registration Statement on Form F-1 (the "Registration Statement") so that the Registration Statement will be declared effective as of 4:15 p.m. Eastern time, on Tuesday, February 17, 2026, or as soon as practicable thereafter. The Company hereby authorizes Alexander T. Yarbrough or Thomas M. Rose, both of whom are attorneys at the Company's outside legal counsel, Troutman Pepper Locke LLP, to orally modify or withdraw this request for acceleration. Once the Registration Statement has been declared effective, please orally confirm that event with Mr. Yarbrough at (704) 998-4077. Thank you for your assistance in this matter. Sincerely, XORTX Therapeutics Inc. /s/ Allen Davidoff Name: Allen Davidoff Title: Chief Executive Officer cc (via email): Thomas M. Rose, Troutman Pepper Locke LLP Alexander T. Yarbrough, Troutman Pepper Locke LLP Ross Carmel, Sichenzia Ross Ference Carmel LLP Thiago Spercel, Sichenzia Ross Ference Carmel LLP
2025-08-05 - UPLOAD - XORTX Therapeutics Inc. File: 377-08272
August 5, 2025
Allen Davidoff
President and Chief Executive Officer
XORTX Therapeutics Inc.
3710–33rd Street NW
Calgary, Alberta, Canada T2L 2M1
Re:XORTX Therapeutics Inc.
Draft Registration Statement on Form F-1
Submitted on July 30, 2025
CIK No. 0001729214
Dear Allen Davidoff:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement at least two business
days prior to the requested effective date and time. 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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Thomas M. Rose
2024-11-22 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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VIA EDGAR
November 22, 2024
Office of Life Sciences
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alan Campbell
Re: XORTX
Therapeutics Inc.
Acceleration Request for Registration Statement on Form F-1
File No. 333-283275
Requested Date: November 25, 2024
Requested Time: 4:00 p.m. Eastern Standard Time
Dear Mr. Campbell:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, XORTX Therapeutics Inc. (the “Company”) hereby requests that the effective date of the above-referenced
registration statement (the “Registration Statement”) be accelerated to November 25, 2024, at 4:00 p.m., Eastern
Time, or as soon thereafter as practicable, unless we or our outside counsel, Troutman Pepper Hamilton Sanders LLP, request by telephone
that such Registration Statement be declared effective at some other time.
Please contact Nicole Edmonds of Troutman Pepper
Hamilton Sanders LLP, counsel to the Company, at (804) 339-1847 to provide notice of effectiveness, or if you have any questions or comments
concerning this request. Thank you for your assistance.
Very Truly Yours,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Allen Davidoff
Chief Executive Officer
2024-11-20 - UPLOAD - XORTX Therapeutics Inc. File: 333-283275
November 20, 2024
Allen Davidoff
President and Chief Executive Officer
XORTX Therapeutics Inc.
3710–33rd Street NW
Calgary, Alberta, Canada T2L 2M1
Re:XORTX Therapeutics Inc.
Registration Statement on Form F-1
Filed November 15, 2024
File No. 333-283275
Dear Allen Davidoff:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Nicole A. Edmonds
2023-02-01 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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VIA EDGAR
February 1, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-3561
Re: XORTX Therapeutics Inc.
Registration Statement on Form F-3 Filed
on January 27, 2023
File No. 333-269429
Acceleration Request
Requested Date: February 3, 2023
Requested Time: 5:00 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act
of 1933, as amended, XORTX Therapeutics Inc. (the “Registrant”) hereby requests that the above-referenced Registration
Statement on Form F-3 (File No. 333-269429) (the “Registration Statement”) be declared
effective at the “Requested Date” and “Requested Time” set forth above.
In the event that there is any change in the acceleration
request set forth in the preceding paragraph, the Registrant will promptly notify the U.S. Securities and Exchange Commission (the “Commission”)
of such change, in which case the Registrant may be making an oral request for acceleration of the effectiveness of the above-captioned
Registration Statement on Form F-3 in accordance with Rule 461 of the General Rules and Regulations under the Securities Act
of 1933, as amended. Such request may be made by any officer of the Registrant.
We request that we be notified of the effectiveness
of the Registration Statement by telephone to Thomas M. Rose of Troutman Pepper Hamilton Sanders LLP, the Registrant’s legal counsel,
by email at thomas.rose@troutman.com or at 757-687-7715. Thank you for your assistance.
Sincerely,
/s/ Amar Keshri
Amar Keshri
Chief Financial Officer
2023-01-31 - UPLOAD - XORTX Therapeutics Inc.
United States securities and exchange commission logo
January 31, 2023
Allen Davidoff
Chief Executive Officer
XORTX Therapeutics Inc.
3710 — 33rd Street NW
Calgary, Alberta, Canada
Re:XORTX Therapeutics Inc.
Registration Statement on Form F-3
Filed January 27, 2023
File No. 333-269429
Dear Allen Davidoff:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Thomas Rose
2022-09-22 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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A.G.P./Alliance Global Partners
590 Madison Avenue
New York, NY 10022
September 22, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
A.G.P./Alliance Global Partners (“A.G.P.”),
as underwriter for the referenced offering, hereby concurs in the request by XORTX Therapeutics Inc. that the effective date of the above-referenced
registration statement be accelerated to 4:30 p.m., Eastern Time, on September 22, 2022, or as soon as practicable thereafter. A.G.P.
affirms that it is aware of its responsibilities under the federal securities laws as they relate to the
issuance of the securities covered by the Registration Statement.
Pursuant to Rule 460 under the Act, please be advised
that A.G.P. will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions
and others, prior to the requested effective time of the Registration Statement.
A.G.P. has been informed by the participating underwriters
that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
Very truly yours,
A.G.P./Alliance Global Partners
By:
/s/ Thomas Higgins
Name:
Thomas Higgins
Title:
Managing Director, Investment Banking
2022-09-22 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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XORTX THERAPEUTICS INC.
3710 - 33rd Street NW
Calgary, Alberta T2L 2M1
Canada
September 22, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, XORTX Therapeutics Inc. (the “Registrant”) hereby requests acceleration of effectiveness
of the registration statement on Form F-1 (File No. 333-267328) (the “Registration Statement”) to 4:30
p.m., Eastern Time, on September 22, 2022, or as soon as practicable thereafter.
The
Registrant understands that the Staff will consider this request as confirmation by the Registrant of its awareness of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Troutman Pepper Hamilton Sanders
LLP, by calling Thomas M. Rose at (757) 687-7715.
Very truly yours,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Name:
Allen Davidoff
Title:
President and Chief Executive Officer
cc: Thomas M. Rose.
2022-09-21 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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XORTX
Therapeutics INC.
3710 – 33rd Street NW
Calgary, Alberta, Canada T2L 2M1
September 21, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attention: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Withdrawal of Request for Acceleration of Effectiveness
Registration Statement on Form F-1
File No.: 333-267328
Ladies and Gentlemen:
Reference is made to our letter,
dated September 19, 2022, in which we requested the acceleration of the effective date of the Registration Statement on Form F-1 (File
No. 333-267328) to September 19, 2022 at 4:30 p.m., Eastern time, or as soon as practicable thereafter.
We are no longer requesting
that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the
effective date.
Please direct any question
to Thomas M. Rose, Esq., at (757) 687-7715.
Sincerely,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Name: Allen Davidoff
Title: CEO
2022-09-19 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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XORTX THERAPEUTICS INC.
3710 - 33rd Street NW
Calgary, Alberta T2L 2M1
Canada
September 19, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, XORTX Therapeutics Inc. (the “Registrant”) hereby requests acceleration of effectiveness
of the registration statement on Form F-1 (File No. 333-267328) (the “Registration Statement”) to 4:30
p.m., Eastern Time, on September 19, 2022, or as soon as practicable thereafter.
The
Registrant understands that the Staff will consider this request as confirmation by the Registrant of its awareness of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Troutman Pepper Hamilton Sanders
LLP, by calling Thomas M. Rose at (757) 687-7715.
Very truly yours,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Name:
Allen Davidoff
Title:
President and Chief Executive Officer
cc: Thomas M. Rose.
2022-09-19 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
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A.G.P./Alliance Global Partners
590 Madison Avenue
New York, NY 10022
September 19, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
A.G.P./Alliance Global Partners (“A.G.P.”),
as underwriter for the referenced offering, hereby concurs in the request by XORTX Therapeutics Inc. that the effective date of the above-referenced
registration statement be accelerated to 4:30 p.m., Eastern Time, on September 19, 2022, or as soon as practicable thereafter. A.G.P.
affirms that it is aware of its responsibilities under the federal securities laws as they relate to the
issuance of the securities covered by the Registration Statement.
Pursuant to Rule 460 under the Act, please be advised
that A.G.P. will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions
and others, prior to the requested effective time of the Registration Statement.
A.G.P. has been informed by the participating underwriters
that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
Very truly yours,
A.G.P./Alliance Global Partners
By:
/s/ Thomas Higgins
Name:
Thomas Higgins
Title:
Managing Director
2022-09-14 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
XORTX
Therapeutics INC.
3710 – 33rd Street NW
Calgary, Alberta, Canada T2L 2M1
September 14, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attention: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Withdrawal of Request for Acceleration of Effectiveness
Registration Statement on Form F-1
File No.: 333-267328
Ladies and Gentlemen:
Reference is made to our letter,
dated September 8, 2022, in which we requested the acceleration of the effective date of the Registration Statement on Form F-1 (File
No. 333-267328) to September 12, 2022 at 4:30 p.m., Eastern time, or as soon as practicable thereafter.
We are no longer requesting
that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the
effective date.
Please direct any question
to Thomas M. Rose, Esq., at (757) 687-7715.
Sincerely,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Name: Allen Davidoff
Title: CEO
2022-09-08 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
A.G.P./Alliance Global Partners
590 Madison Avenue
New York, NY 10022
September 8, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
A.G.P./Alliance Global Partners (“A.G.P.”),
as underwriter for the referenced offering, hereby concurs in the request by XORTX Therapeutics Inc. that the effective date of the above-referenced
registration statement be accelerated to 4:30 p.m., Eastern Time, on September 12, 2022, or as soon as practicable thereafter. A.G.P.
affirms that it is aware of its responsibilities under the federal securities laws as they relate to the
issuance of the securities covered by the Registration Statement.
Pursuant to Rule 460 under the Act, please be advised
that A.G.P. will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions
and others, prior to the requested effective time of the Registration Statement.
A.G.P. has been informed by the participating underwriters
that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
[Signature page follows]
Very truly yours,
A.G.P./Alliance Global Partners
By:
/s/Thomas J. Higgins
Name:
Thomas J. Higgins
Title:
Managing Director, Investment Banking
2022-09-08 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
XORTX THERAPEUTICS INC.
3710 - 33rd Street NW
Calgary, Alberta T2L 2M1
Canada
September 8, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Attn: Joshua Gorsky
Re:
XORTX Therapeutics Inc.
Registration Statement on Form F-1
File No. 333-267328
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, XORTX Therapeutics Inc. (the “Registrant”) hereby requests acceleration of effectiveness
of the registration statement on Form F-1 (File No. 333-267328) (the “Registration Statement”) to 4:30
p.m., Eastern Time, on September 12, 2022, or as soon as practicable thereafter.
The
Registrant understands that the Staff will consider this request as confirmation by the Registrant of its awareness of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. Once
the Registration Statement has been declared effective, please orally confirm that event with our counsel, Troutman Pepper Hamilton Sanders
LLP, by calling Thomas M. Rose at (757) 687-7715.
Very truly yours,
XORTX Therapeutics Inc.
By:
/s/ Allen Davidoff
Name:
Allen Davidoff
Title:
President and Chief Executive Officer
cc: Thomas M. Rose.
2022-08-16 - UPLOAD - XORTX Therapeutics Inc.
United States securities and exchange commission logo
August 16, 2022
Allen Davidoff, PhD
President and Chief Executive Officer
XORTX Therapeutics Inc.
3710 – 33rd Street NW
Calgary, Alberta, Canada T2L 2M1
Re:XORTX Therapeutics Inc.
Draft Registration Statement on Form F-1
Submitted August 15, 2022
CIK No. 0001729214
Dear Dr. Davidoff:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. 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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Thomas M. Rose
2021-10-08 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
October
8, 2021
VIA
EDGAR
U.S. Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn: Alan
Campbell
Joe
McCann
Re:
XORTX
Therapeutics Inc. (the “Company”)
Registration
Statement on Form F-1/A
File
No. 333-258741
Acceleration
Request
Requested
Date: October 12, 2021
Requested
Time: 4:30 p.m., Eastern Standard Time
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Alliance Global Partners,
as representative of the several underwriters, hereby joins the Company in requesting that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the Registration Statement on Form F-1/A (File No. 333-258741)
(the “Registration Statement”) to become effective on Tuesday, October 12, 2021, at 4:30 p.m., Eastern Standard
Time, or as soon as practicable thereafter.
Pursuant
to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary
prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement.
We
have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, to the extent applicable.
[Signature
Page Follows]
Very
truly yours,
Alliance
Global Partners
By:
Name:
Title:
cc:
Allen Warren Davidoff, XORTX Therapeutics Inc.
Anthony
Epps, Dorsey & Whitney LLP
Ivan
Blumenthal, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2021-10-08 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
October
8, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Re:
XORTX Therapeutics Inc. (the "Company")
Registration
Statement on Form F-1
File
No. 333-258741
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date
of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:30PM on October 12, 2021, or
as soon thereafter as is practicable, unless we or our outside counsel, Dorsey & Whitney LLP, request by telephone that such Registration Statement be declared effective
at some other time.
Very
truly yours,
XORTX
Therapeutics Inc.
By:
/s/ Allen Davidoff
Name:
Allen Davidoff
Title:
Chief Executive Officer
2021-09-16 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
CONFIDENTIAL
September
16, 2021
CONFIDENTIAL
SUBMISSION VIA EDGAR
Division
of Corporation Finance
Office
of Life Sciences
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attn: Jeanne Bennett, Mary Mast, Alan
Campbell, and Joe McCann
Re: Responses
to the Securities and Exchange Commission
Staff Comments
dated September 1, 2021 regarding
XORTX Therapeutics
Inc.
Registration
Statement on Form F-1
Filed August
11, 2021
Dear
Sirs and Madams:
This
letter responds to the written comments from the staff (the “Staff”) of the Securities and Exchange Commission (the
“SEC”) set forth in the September 1, 2021 letter regarding the above-referenced Registration Statement on Form
F-1 (the “Registration Statement”) of XORTX Therapeutics Inc. (the “Company”, “we,”
“our,” or “us”) filed on August 11, 2021. For your convenience, the Staff’s comments
are included below and we have numbered our responses accordingly. Simultaneously with the transmission of this letter, the Company
is filing via EDGAR an amendment (“Amendment No. 1”) to the Registration Statement, responding to the Staff’s
comments and including certain other revisions and updates.
Page
numbers in the text of the Company’s responses correspond to page numbers in Amendment No. 1. Please note that capitalized
terms used but not otherwise defined in this letter have the meanings ascribed to such terms in Amendment No. 1.
Our
responses are as follows:
Registration
Statement on Form F-1
Our
Proprietary Pipeline-in-a-Product, page 2
Staff
Comment No. 1.
We
note your revised disclosure stating that oxypurinol may be used "as an effective alternative" to allopurinol. Efficacy
is a determination solely within the purview of the FDA and similar foreign regulators. Please revise your disclosure to remove
this claim.
September
16, 2021
Page
2
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure on Page 2 to remove the efficacy claim.
Staff
Comment No. 2.
We
note your response to prior comment 4 and revised disclosure. Please clarify whether all of the patients in the two studies mentioned
were intolerant of allopurinol. To the extent not all patients were intolerant of allopurinol, please specify what percentage
of patients were intolerant of allopurinol and how many of those patients were able to tolerate oxypurinol. Also, disclose the
year when the two referenced studies were conducted.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure on page 2 to reflect the year the studies were documented.
All of the patients in the two studies mentioned were intolerant of allopurinol.
Risk
Factors
Common
Share Purchase Warrants are speculative in nature., page 53
Staff
Comment No. 3.
Your
disclosure is unclear regarding whether this risk factor applies to both the Common Share Purchase Warrants and the pre-funded
warrants or only to the Common Share Purchase Warrants. Please advise.
Company’s
Response:
In
response to the Staff’s comment, we have revised the risk factor on page 53 to clarify that the risk applies to both Common
Share Purchase Warrants and pre-funded warrants.
Capitalization,
page 64
Staff
Comment No. 4.
You
have included your current liabilities, Accounts payable and accrued liabilities and Derivative warrant liability, in your Capitalization
table. Please tell us why these amounts are appropriate to be included or remove them from the table.
September
16, 2021
Page
3
Company’s
Response:
In
response to the Staff’s comment, we have revised the capitalization table on page 64 to remove those line items.
Business
Product
Candidates, page 76
Staff
Comment No. 5.
We
note your response to prior comment 10. We further note that your disclosure throughout the prospectus indicates that you have
not commenced any Phase 3 clinical trials. Accordingly, please remove the arrows in the Phase 3 column for XRx-008 and XRx-101.
Company’s
Response:
In
response to the Staff’s comment, we have revised the diagram on page 77 to remove the arrows in the Phase 3 column.
September
16, 2021
Page
4
Thank
you for your review of the filing. If you should have any questions regarding the response letter, please do not hesitate to contact
the undersigned at (403) 607-2621, or Anthony W. Epps of Dorsey & Whitney LLP, our outside legal counsel at (303) 352-1109.
Sincerely,
XORTX
Therapeutics Inc.
Allen
Davidoff
President
and Chief Executive Officer
cc: Anthony
W. Epps, Dorsey & Whitney LLP
2021-09-01 - UPLOAD - XORTX Therapeutics Inc.
United States securities and exchange commission logo
September 1, 2021
Allen Davidoff
President and Chief Executive Officer
XORTX Therapeutics Inc.
Suite 4000, 421 – 7th Avenue SW
Calgary, Alberta, Canada T2P 4K9
Re:XORTX Therapeutics Inc.
Registration Statement on Form F-1
Filed August 11, 2021
File No. 333-258741
Dear Mr. Davidoff:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1
Our Proprietary Pipeline-in-a-Product, page 2
1.We note your revised disclosure stating that oxypurinol may be used "as an effective
alternative" to allopurinol. Efficacy is a determination solely within the purview of the
FDA and similar foreign regulators. Please revise your disclosure to remove this claim.
2.We note your response to prior comment 4 and revised disclosure. Please clarify whether
all of the patients in the two studies mentioned were intolerant of allopurinol. To the
extent not all patients were intolerant of allopurinol, please specify what percentage of
patients were intolerant of allopurinol and how many of those patients were able to
tolerate oxypurinol. Also, disclose the year when the two referenced studies were
conducted.
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
September 1, 2021 Page 2
FirstName LastName
Allen Davidoff
XORTX Therapeutics Inc.
September 1, 2021
Page 2
Risk Factors
Common Share Purchase Warrants are speculative in nature., page 53
3.Your disclosure is unclear regarding whether this risk factor applies to both the Common
Share Purchase Warrants and the pre-funded warrants or only to the Common Share
Purchase Warrants. Please advise.
Capitalization, page 64
4.You have included your current liabilities, Accounts payable and accrued liabilities and
Derivative warrant liability, in your Capitalization table. Please tell us why these amounts
are appropriate to be included or remove them from the table.
Business
Product Candidates, page 76
5.We note your response to prior comment 10. We further note that your disclosure
throughout the prospectus indicates that you have not commenced any Phase 3 clinical
trials. Accordingly, please remove the arrows in the Phase 3 column for XRx-008 and
XRx-101.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Jeanne Bennett at 202-551-3606 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Anthony W. Epps
2021-08-11 - CORRESP - XORTX Therapeutics Inc.
CORRESP
1
filename1.htm
August
11, 2021
SUBMISSION VIA EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jeanne Bennett, Mary Mast, Alan Campbell, and Joe McCann
Re: Responses to the Securities and Exchange Commission
Staff Comments dated August 2, 2021 regarding
XORTX Therapeutics Inc.
Amended Draft Registration Statement on Form F-1
Submitted July 21, 2021
CIK No. 0001729214
Dear
Sirs and Madams:
This
letter responds to the written comments from the staff (the “Staff”) of the
Securities and Exchange Commission (the “SEC”) set forth in the August
2, 2021 letter regarding the above-referenced confidential Amended Draft
Registration Statement on Form F-1 (the “Registration Statement”)
of XORTX Therapeutics Inc. (the “Company”, “we,” “our,”
or “us”) confidentially submitted on July 21, 2021. For your
convenience, the Staff’s comments are included below and we have numbered our
responses accordingly. Simultaneously with the transmission of this letter,
the Company is submitting via EDGAR to the Registration Statement, responding
to the Staff’s comments and including certain other revisions and updates.
Page
numbers in the text of the Company’s responses correspond to page numbers in
the Registration Statement. Please note that capitalized terms used but not
otherwise defined in this letter have the meanings ascribed to such terms in
the Registration Statement.
Our
responses are as follows:
Amendment
No. 1 to Draft Registration Statement on Form F-1
Cover Page
August 11, 2021
Page 2
Staff Comment No. 1.
We note your response to prior comment 2 and your statement that the
assumed offering price and assumed exercise price for the Common Share Purchase
will be for “illustrative purposes only” and that the public offering prices in
the prospectus “may not be indicative of the final offering price.” However,
Item 501(b)(3) of Regulation S-K requires that you disclose the offering price
of the securities, or a bona fide estimate of the range of the maximum offering
price, on the cover page as well as the maximum number of securities offered.
Accordingly, please confirm that you will insert the offering price of the
securities, or a range that complies with applicable requirements, in a future
filing prior to effectiveness, rather than an illustrative price that “may not
be indicative of the final offering price” and please remove your corresponding
disclosure stating that the public offering price and assumed exercise price of
the Common Share Purchase Warrants may not be indicative of the final offering
price.
In addition, we note your statement that the actual public offering
price will not be determined by the market price of the Company’s common shares
on the Canadian Securities Exchange (“CSE”). However, the disclosure in the
first sentence on the cover page states that your offering price will be “based
on the last reported price of [y]our common shares on the Canadian Securities
Exchange...” Please advise.
Company’s
Response:
We
can confirm that we will insert the offering price of the securities or a range
that complies with applicable requirements in a future filing prior to
effectiveness. We have removed the corresponding disclosure stating that the
public offering price and assumed exercise price of the Common Share Purchase
Warrants may not be indicative of the final offering price. We have also
updated the disclosure throughout to remove references that the offering price
will be based on the last report price of our shares on the Canadian Securities
Exchange.
Staff
Comment No. 2.
We note your disclosure indicating that the common shares and Common
Share Purchase Warrants are only being offered together. To the extent you are
offering the common shares and Common Share Purchase Warrants together, you
must register them as Units in your offering, even if the common shares and
Common Share Purchase Warrants are immediately separable following the
offering. If you plan to offer Units, please revise the registration statement
fee table and prospectus cover page to identify the Units as securities in the
offering, identifying the components of the Units. The pricing table on the
prospectus cover page should reflect the common shares and Common Share
Purchase Warrants priced as one security with a footnote indicating the
assigned values to each of the securities. For guidance, please refer to
Questions 240.05 and 240.06 of our Compliance and Disclosure Interpretations,
Securities Act Rules.
August 11, 2021
Page 3
Company’s Response:
Per
discussions with the Staff we have made edits on the cover page and to the
“Offering” section to make it clear that the securities offered in the offering
will not be offered together as units and that the common shares and Common
Share Purchase Warrants will not be required to be purchased together.
Prospectus
Summary
Overview, page 1
Staff
Comment No. 3.
Your disclosure in the second paragraph here and on page 75 states that
your pipeline-in-a-product strategy is supported by proposed clinical trials
with experienced clinicians. However, elsewhere in the prospectus, your
revised disclosure indicates that you are still in the processing of choosing a
contract research organization to conduct your clinical trials. Please
reconcile your disclosure or advise.
Please also revise your disclosure in the Prospectus Summary to reflect
your disclosure elsewhere in the prospectus that you have not conducted any
clinical trials for any of your product candidates.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at pages 2 and
75 to reflect that we plan
to conduct clinical trials with experienced clinicians. We have
also revised the disclosure at pages 3, 81 and 84 to clarify that we have
not conducted any clinical trials for any of our product candidates.
Staff
Comment No. 4.
We note your revised disclosures stating that oxypurinol has been well
tolerated when administered orally in clinical trials and clinical settings.
Please revise the Prospectus Summary, where appropriate, to briefly describe
the clinical trials where oxypurinol was found to be well tolerated.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at pages 2,
80 to reflect details of the third party conducted studies that document that
toleration of oxypurinol. Our information is based upon that in Section 7.2.1 of FDA Arthritis
Drugs Advisory Committee June 2, 2004 Briefing Document for Oxypurinol
Capsules, NDA 21-740 by Cardiome Pharma Corp.
Staff
Comment No. 5.
We note that it appears unclear whether oxypurinol has ever received a
final marketing approval. Please clarify here and in the Business section
whether oxypurinol received a final marketing approval and discuss whether the
505(b)(2) pathway is availability for products that have
not received a final marketing approval. Please also revise to discuss that
the prior FDA review of oxypurinol was for a different indication than the ones
you are targeting.
August 11, 2021
Page 4
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at pages 3,
74, 75, 81 and 82 to reflect that oxypurinol has not received final FDA marketing
approval. We also revised the disclosure at pages 3, 75 and 76 to clarify
that the Company’s use of the 505(b)(2) pathway will rely on data referenced within a third
party NDA originally developed for the indication of allopurinol intolerant
gout.
Readily
scalable and transferable., page 4
Staff
Comment No. 6.
We note your response to prior comment 6 and revised disclosure.
Please revise further to clarify that there is no guarantee that the FDA will
approve your uric lowering agent products for the treatment of kidney disease
or the health consequences of diabetes.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at pages 4,
76 to reflect that there is no guarantee that the FDA will approve our proposed
uric acid lowering agent products for the treatment of kidney disease or the
health consequences of diabetes.
Implications
of Being and Emerging Growth Company, page 6
Staff
Comment No. 7.
Refer to our prior comment 14. Please expand here and on pages 52 and
74 to address the transition period for complying with new and revised
accounting guidance as allowed by Section 107 of the JOBS Act and
Section 7(a)(2)(B) of the Securities Act of 1933.
Company’s
Response:
In response
to the Staff’s comment, the Company has revised the disclosure on the cover page, on pages 6, 52, 53, and 73 of the Registration Statement to state that the Company will not take advantage of the extended
transition period for emerging growth companies for complying with new or revised accounting guidance as allowed by Section 107 of the
JOBS Act and Section 7(a)(2)(B) of the Securities Act of 1933.
August 11, 2021
Page 5
Use of Proceeds, page 63
Staff
Comment No. 8.
We refer to prior comment 17 and re-issue in part. Please revise to
disclose how far you expect to reach in the development of your three lead
product candidates with the proceeds from this offering. If the proceeds will
not be sufficient to fund all of the proposed purposes, disclose the priority
of such purposes as well as the amount and sources of other funds needed.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure on page 63 to
add detail related to how far we expect to reach with the proceeds of the
offering, and the priority of such purposes.
Capitalization,
page 64
Staff
Comment No. 9.
Please update your Capitalization Table as of March 31, 2021.
Company’s
Response:
In
response to the Staff’s comment, we have updated the capitalization table on
page 64 to reflect a March 31, 2021 date.
Business
Product Candidates, page 76
Staff
Comment No. 10.
Please revise your pipeline graphic to clarify that you have not
conducted Phase 1 or Phase 2 trials of your product candidates and that there
is no guarantee that the FDA will permit you to directly proceed to a Phase 3
trial for XRx-008 or XRx-101.
Company’s
Response:
In
response to the Staff’s comment, we have revised the pipeline graphic on page
77 and added clarifying language on page 77.
Staff
Comment No. 11.
We note your response to prior comment 21 and re-issue. Please revise
your pipeline chart to shorten the arrow for XRx-225 to reflect its current
development status as you have indicated in your disclosure and response letter
that XRx-225 has not yet completed preclinical studies.
August 11, 2021
Page 6
Company’s Response:
In
response to the Staff’s comment, we have revised the pipeline graphic on page
77.
Prior
FDA Review of Oxypurinol, page 79
Staff
Comment No. 12.
Please revise this section to discuss the meaning of the term
“approvable letter” and to disclose whether oxypurinol received a final
marketing approval.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at page 79 to
clarify the information from third-party Cardiome Pharma Corp and to clarify
that the FDA did not give final marketing approval for oxypurinol. We are
relying on the June 24, 2004 information in the press release available at https://www.drugs.com/nda/oxyprim_040624.html.
Strategic
Partnerships and Collaborations, page 84
Staff
Comment No. 13.
We note your response to prior comment 27 and re-issue in part. Please
revise your descriptions of both agreements included in this section to
disclose the product candidates that are subject to each agreement. Please
also disclose the royalty rate, or a range no greater than 10 percentage
points, for your agreement with the Vendors. In addition, with respect to the
UFRF agreement, provisions providing the contracting party the right to
terminate the agreement for failure to meet milestone events are material to
investors, please expand your disclosures to describe the milestone events and
the dates by which you are required to achieve them.
Please also revise the Prospectus Summary to describe which of your
product candidates are subject to license agreements and file these agreements
as exhibits to your registration statement. In your revisions, please clearly
state whether you own or license oxypurinol.
Company’s
Response:
In
response to the Staff’s comment, we have revised the disclosure at pages 3,
85, 86 and 87 to add the product candidates that are subject to each
agreement, clarify the range of royalty rate under the Vendors Agreement, and
add the outstanding milestone events under the UFRF License Agreement.
August 11, 2021
Page 7
Independent Auditors’ Report, page F-2
Staff
Comment No. 14.
Refer to our prior comment 32 and your response. We note that the
revised report refers to the “consolidated statements of loss and comprehensive
loss” while the statements themselves are titled “consolidated statements of
comprehensive loss”. Please revise to be consistent with the exact title.
Company’s
Response:
In
response to the Staff’s comment, we have revised the reference on page F-2 to
be “consolidated statements of comprehensive loss.”
Staff
Comment No. 15.
Refer to our prior comment 34. We see the revised audit report does
not present the signature (name) of the audit firm. Please revise for this
issue.
Company’s
Response:
In
response to the Staff’s comment, we have added the name of the audit firm on
page F-3.
Condensed
Interim Consolidated Statements of Comprehensive Loss, page F-27
Staff
Comment No. 16.
We see the columns of financial data on the Consolidated Statements of
Comprehensive Loss are labeled 2020 and 2019. Please revise to present your
financial data for the three months ended March 31, 2021 and 2020.
Also please revise page F-25 to clarify the Consolidated Statements of
Financial Position are as of March 31, 2021 and December 31, 2020.
Company’s
Response:
In
response to the Staff’s comment, we have revised the tables on pages F-33 and
F-34 to reflect the correct periods.
August 11, 2021
Page 8
Thank you for your review of the filing. If you
should have any questions regarding the response letter, please do not hesitate
to contact the undersigned at (403) 607-2621, or Anthony W. Epps of
Dorsey & Whitney LLP, our outside legal counsel at (303) 352-1109.
Sincerely,
XORTX Therapeutics Inc.
Allen Davidoff
President and Chief Executive Officer
cc: Anthony
W. Epps, Dorsey & Whitney LLP
2021-08-02 - UPLOAD - XORTX Therapeutics Inc.
United States securities and exchange commission logo
August 2, 2021
Allen Davidoff
President and Chief Executive Officer
XORTX Therapeutics Inc.
Suite 4000, 421 – 7th Avenue SW
Calgary, Alberta
Canada T2P 4K9
Re:XORTX Therapeutics Inc.
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted July 21, 2021
CIK No. 0001729214
Dear Mr. Davidoff:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form F-1
Cover Page
1.We note your response to prior comment 2 and your statement that the assumed offering
price and assumed exercise price for the Common Share Purchase will be for "illustrative
purposes only" and that the public offering prices in the prospectus "may not be indicative
of the final offering price." However, Item 501(b)(3) of Regulation S-K requires that you
disclose the offering price of the securities, or a bona fide estimate of the range of the
maximum offering price, on the cover page as well as the maximum number of securities
offered. Accordingly, please confirm that you will insert the offering price of the
securities, or a range that complies with applicable requirements, in a future filing prior to
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
August 2, 2021 Page 2
FirstName LastNameAllen Davidoff
XORTX Therapeutics Inc.
August 2, 2021
Page 2
effectiveness, rather than an illustrative price that "may not be indicative of the final
offering price" and please remove your corresponding disclosure stating that the public
offering price and assumed exercise price of the Common Share Purchase Warrants may
not be indicative of the final offering price.
In addition, we note your statement that the actual public offering price will not be
determined by the market price of the Company's common shares on the Canadian
Securities Exchange ("CSE"). However, the disclosure in the first sentence on the cover
page states that your offering price will be "based on the last reported price of [y]our
common shares on the Canadian Securities Exchange..." Please advise.
2.We note your disclosure indicating that the common shares and Common Share Purchase
Warrants are only being offered together. To the extent you are offering the common
shares and Common Share Purchase Warrants together, you must register them as Units in
your offering, even if the common shares and Common Share Purchase Warrants are
immediately separable following the offering. If you plan to offer Units, please revise the
registration statement fee table and prospectus cover page to identify the Units as
securities in the offering, identifying the components of the Units. The pricing table on the
prospectus cover page should reflect the common shares and Common Share Purchase
Warrants priced as one security with a footnote indicating the assigned values to each of
the securities. For guidance, please refer to Questions 240.05 and 240.06 of our
Compliance and Disclosure Interpretations, Securities Act Rules.
Prospectus Summary
Overview, page 1
3.Your disclosure in the second paragraph here and on page 75 states that your pipeline-in-
a-product strategy is supported by proposed clinical trials with experienced clinicians.
However, elsewhere in the prospectus, your revised disclosure indicates that you are still
in the processing of choosing a contract research organization to conduct your clinical
trials. Please reconcile your disclosure or advise.
Please also revise your disclosure in the Prospectus Summary to reflect your disclosure
elsewhere in the prospectus that you have not conducted any clinical trials for any of your
product candidates.
4.We note your revised disclosures stating that oxypurinol has been well tolerated when
administered orally in clinical trials and clinical settings. Please revise the Prospectus
Summary, where appropriate, to briefly describe the clinical trials where oxypurinol was
found to be well tolerated.
5.We note that it appears unclear whether oxypurinol has ever received a final marketing
approval. Please clarify here and in the Business section whether oxypurinol received a
final marketing approval and discuss whether the 505(b)(2) pathway is availability for
products that have not received a final marketing approval. Please also revise to discuss
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
August 2, 2021 Page 3
FirstName LastNameAllen Davidoff
XORTX Therapeutics Inc.
August 2, 2021
Page 3
that the prior FDA review of oxypurinol was for a different indication than the ones you
are targeting.
Readily scalable and transferable., page 4
6.We note your response to prior comment 6 and revised disclosure. Please revise further to
clarify that there is no guarantee that the FDA will approve your uric lowering agent
products for the treatment of kidney disease or the health consequences of diabetes.
Implications of Being an Emerging Growth Company, page 6
7.Refer to our prior comment 14. Please expand here and on pages 52 and 74 to address the
transition period for complying with new and revised accounting guidance as allowed by
Section 107 of the JOBS Act and Section 7(a)(2)(B) of the Securities Act of 1933.
Use of Proceeds, page 63
8.We refer to prior comment 17 and re-issue in part. Please revise to disclose how far you
expect to reach in the development of your three lead product candidates with the
proceeds from this offering. If the proceeds will not be sufficient to fund all of the
proposed purposes, disclose the priority of such purposes as well as the amount and
sources of other funds needed.
Capitalization, page 64
9.Please update your Capitalization Table as of March 31, 2021.
Business
Product Candidates, page 76
10.Please revise your pipeline graphic to clarify that you have not conducted Phase 1 or
Phase 2 trials of your product candidates and that there is no guarantee that the FDA will
permit you to directly proceed to a Phase 3 trial for XRx-008 or XRx-101.
11.We note your response to prior comment 21 and re-issue. Please revise your pipeline chart
to shorten the arrow for XRx-225 to reflect its current development status as you have
indicated in your disclosure and response letter that XRx-225 has not yet completed
preclinical studies.
Prior FDA Review of Oxypurinol, page 79
12.Please revise this section to discuss the meaning of the term "approvable letter" and to
disclose whether oxypurinol received a final marketing approval.
Strategic Partnerships and Collaborations, page 84
13.We note your response to prior comment 27 and re-issue in part. Please revise your
descriptions of both agreements included in this section to disclose the product candidates
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
August 2, 2021 Page 4
FirstName LastName
Allen Davidoff
XORTX Therapeutics Inc.
August 2, 2021
Page 4
that are subject to each agreement. Please also disclose the royalty rate, or a range no
greater than 10 percentage points, for your agreement with the Vendors. In addition, with
respect to the UFRF agreement, provisions providing the contracting party the right to
terminate the agreement for failure to meet milestone events are material to investors,
please expand your disclosures to describe the milestone events and the dates by which
you are required to achieve them.
Please also revise the Prospectus Summary to describe which of your product candidates
are subject to license agreements and file these agreements as exhibits to your registration
statement. In your revisions, please clearly state whether you own or license oxypurinol.
Independent Auditors' Report, page F-2
14.Refer to our prior comment 32 and your response. We note that the revised report refers to
the “consolidated statements of loss and comprehensive loss” while the statements
themselves are titled “consolidated statements of comprehensive loss”. Please revise to be
consistent with the exact title.
15.Refer to our prior comment 34. We see the revised audit report does not present the
signature (name) of the audit firm. Please revise for this issue.
Condensed Interim Consolidated Statements of Comprehensive Loss, page F-27
16.We see the columns of financial data on the Consolidated Statements of Comprehensive
Loss are labeled 2020 and 2019. Please revise to present your financial data for the three
months ended March 31, 2021 and 2020. Also please revise page F-25 to clarify the
Consolidated Statements of Financial Position are as of March 31, 2021 and December 31,
2020.
You may contact Jeanne Bennett at 202-551-3606 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Anthony W. Epps
2021-06-28 - UPLOAD - XORTX Therapeutics Inc.
United States securities and exchange commission logo
June 25, 2021
Allen Davidoff
President and Chief Executive Officer
XORTX Therapeutics Inc.
Suite 4000, 421 – 7th Avenue SW
Calgary, Alberta
Canada T2P 4K9
Re:XORTX Therapeutics Inc.
Draft Registration Statement on Form F-1
Submitted May 26, 2021
CIK No. 0001729214
Dear Mr. Davidoff:
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 F-1
Cover Page
1.Please clarify whether your reference to "Public Warrants" in the first paragraph of the
prospectus cover page is a reference to the Common Share Purchase Warrants being
offered or to different warrants.
2.We note your statement that you intend to offer shares at an "assumed public offering
price" which is based on the last reported price of your common shares on the Canadian
Securities Exchange. Please revise your disclosure to explain how you will use the trading
price on the Canadian Securities Exchange to determine the offering price of both your
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 2
FirstName LastNameAllen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 2
common shares and Common Share Purchase Warrants. Please refer to the instructions to
Item 501(b)(3) of Regulation S-K which require bona fide pricing information for
offerings by companies not subject to the reporting requirements of Section 13(a) or 15(d)
of the Exchange Act.
3.Please revise your description of the compensation to be paid to A.G.P. to include a
discussion of the compensation warrant discussed on page 137.
Our Proprietary Therapeutic Platforms, page 2
4.Please revise your disclosure here and in Business to explain the difference between your
"proprietary therapeutic platforms" and your product candidates. Also, balance your
discussion in this section and in Business to clarify, if true, that your product candidates
and therapeutic platforms are still in preclinical and clinical development, the process of
product development is inherently uncertain and any potential advantages of your product
candidates are speculative. Please also explain to us the basis for your statement that your
platforms can be used alone, or in combination, with synergistic activity to develop an
approach to a variety of diseases.
5.Please provide us with the basis for your statement that your "platforms can be combined
in multiple ways and this synergy can be applied to address acute, intermittent or chronic
disease progression." In that regard, we note that you have yet to develop any product
candidates that have advanced to a Phase 3 clinical trial or received a marketing approval.
6.Please remove your statement here and in Business that you will have the opportunity to
provide "first-in-class" products.
Prospectus Summary
Overview, page 2
7.Please revise the Prospectus Summary, where appropriate, to briefly explain the current
regulatory status of oxypurinol and the difference between oxypurinol and allopurinol.
Please also provide a brief discussion of how your product candidates differ from
oxypurinol.
8.We note your statements here and throughout the Prospectus Summary, MD&A and
Business that you are focusing on treating "orphan" indications. Please refrain from
stating that you are targeting orphan indications unless you have obtained orphan drug
designation.
9.We note your statement that you "combine the power of oxypurinol with innovative
therapeutic products existing drugs that can be adapted for different disease indications
where elevated uric acid is a common denominator." Please revise here and in Business to
explain what is meant by this sentence and whether you have actually combined
oxypurinol with other existing drugs to create new product candidates.
We further note your statement that you intend to treat a variety of serious or life-
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 3
FirstName LastNameAllen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 3
threatening diseases. Please revise your disclosure here and throughout to clarify, if true,
that you have not developed any product candidates to treat diseases beyond ADPKD,
T2DN and AKI due to coronavirus infection.
Our Strategy, page 3
10.Please revise your statements here and throughout that you will rapidly and efficiently
advance XRx-008 through Phase 3 clinical development and regulatory approval. You
may state, if true, that you plan to submit an NDA to the FDA following the conclusion of
your Phase 3 clinical trial of XRx-008.
Product Candidate Pipeline, page 3
11.We note your statement here and in Business that XRx-008 is in preparations for a Phase
3 trial, the last stage before FDA approval. Please revise to disclose whether you have an
active IND for this trial and to clarify that there is no guarantee that the results from this
trial will be positive or that the FDA will view the results from this trial to be sufficient
for a marketing approval.
Risk Factors, page 3
12.Please revise to highlight the risk factor discussed on page 54 concerning your belief that
were a PFIC during fiscal 2020 and potential adverse tax consequences to stockholders.
Implications of Being an Emerging Growth Company, page 5
13.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Implications off Being an Emerging Growth Company, page 5
14.We note the discussion that you qualify as an “emerging growth company” as defined in
the JOBS Act. Please revise to disclose in the filing, including MD&A, whether you
intend to take advantage of the extended transition period allowed for emerging growth
companies for complying with new or revised accounting guidance as allowed by Section
107 of the JOBS Act and Section 7(a)(2)(B) of the Securities Act of 1933.
Risk Factors
Our commercial success depends significantly on our ability to operate without infringing the
patents..., page 35
15.We note your statement that you are aware of third party patents and patent applications
"containing claims." Please revise your disclosure to clarify if these claims are directed
towards your product candidates or technology.
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 4
FirstName LastName
Allen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 4
Market, Industry and Other Data, page 60
16.Your statements that you have not independently verified any third party information may
imply an inappropriate disclaimer of responsibility with respect to this information. Please
either delete these statements or specifically state that you are responsible for such
information.
Use of Proceeds, page 61
17.Please revise this section to provide more specificity regarding the use of proceeds from
the offering including the approximate amount of funds you plan to allocate toward each
of your three lead product candidates. If the proceeds will not be sufficient to fund all of
the proposed purposes, disclose the priority of such purposes as well as the amount and
sources of other funds needed.
Capitalization, page 62
18.We note that you include your statement of financial condition from page F-4 in the
Capitalization section. Revise to only include capitalization and indebtedness. If you
present cash, place a double line below the cash line.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Research and Development Expense, page 68
19.We note the increase in your research and development expenses and from page 73 that
you have multiple products in varying stages of development. Please revise to provide
more detail for your research and development expenses for each period presented
including, but not limited to, by product candidate as well as by the nature of the
expenses. To the extent that you do not track expenses by product candidate, please
disclose as such.
Business, page 72
20.Please revise your Business section, where appropriate, to discuss the results of the
clinical trials of your product candidates. In your revisions, please disclose who conducted
the trial, the phase of the trial, the primary and secondary endpoints and whether the trial
achieved these endpoints, metrics utilized, the number and nature of any drug-related
adverse events and the duration of the trial.
Product Candidate Pipeline, page 73
21.Your pipeline chart indicates that XRx-225 has completed preclinical studies. However,
your disclosure on page 79 appears to indicate that XRx-225 still needs to complete
preclinical studies before advancing to Phase 1 clinical testing. Please revise your pipeline
chart to shorten the arrow for XRx-225 to reflect its current development status or advise.
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 5
FirstName LastName
Allen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 5
Anticipated clinical development of XRx-008, page 77
22.We note your statement that oxypurinol has not been approved for marketing anywhere in
the world, though it has previously received FDA review under an NDA filing. Please
revise to discuss the circumstances of this FDA filing, including who made the filing and,
if known, why the FDA did not approve the product candidate under review.
23.We note your statement that if XRx-008 is approved, it would fit well in combination with
other pulmonary and cardiovascular products. Please revise to provide the basis for this
statement and to clarify whether XRx-008 has been clinically evaluated in combination
with other product candidates.
24.We note your statements that you are preparing for a bridging pharmacokinetic study and
a Phase 3 clinical trial of XRx-008. Please revise to disclose for each trial who will
conduct the trial, the primary and secondary endpoints, metrics utilized and the planned
duration of the trial.
Anticipated clinical development of XRx-101, page 78
25.We note your statement that you expect to conduct a Phase 3 pivotal clinical trial of XRx-
101 to evaluate whether it can attenuate acute tissue injuries in the setting of COVID-19
infection. Please revise to disclose who will conduct the trial, the primary and secondary
endpoints, metrics utilized and the planned duration of the trial.
XRx-225, page 78
26.Please revise your disclosure to provide the source for your claim that T2DN is forecast to
double in the next decades and provide more precision regarding the time period over
which T2DN is anticipated to double (e.g. next 10 years, 20 years, etc.).
Strategic Partnerships and Collaborations, page 79
27.Your disclosure on page 44 indicates that you license technology from the University of
Florida, the University of Washington and Dr. Richard Johnson. Please revise this
subsection of your Business section to disclose the material terms of these license
agreements, as well as any other license agreements that are material to your
business, including:
•the technology or product candidates subject to the agreement;
•each parties' rights and obligations under the agreement;
•quantify all payment made to date;
•disclose separately the aggregate amount of all potential development, regulatory and
commercial milestone payments;
•disclose any milestones that you are required to achieve pursuant to the agreements;
•disclose the amount of option fees for additional targets;
•quantify the royalty rate, or a range no greater than 10 percentage points per tier;
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 6
FirstName LastNameAllen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 6
•disclose when royalty provisions expire, if the expiration is based on a number of
years following commercialization, disclose the number of years;
•disclose the expiration date; and
•describe any termination provisions.
Please also revise your Prospectus Summary to briefly explain which of your products and
technology are subject to license agreements. Finally, please file these agreements as
exhibits to your registration statement.
Competition, page 81
28.Please remove your statement that XRX-008 is a "potent oral uric acid lowering agent that
does not require hospital administration and has a much superior safety profile" to
Jynarque. Given the current stage of development of this product candidate, it appears to
be premature to make this claim.
Similarly, please remove your statements that "XRX-101 will be a more effective and
better therapy...because it will be both potent and safe" and that "XRX-225 will be a more
effective and better therapy because it has been shown to be a powerful and safe uricacid
lowering agent."
Certain Relationships and Related Party Transactions, page 112
29.Please revise your disclosure to provide more specificity regarding the clinical trials that
are being supported by Prevail including the services that Prevail is providing, the product
candidates being evaluated and the timing of the clinical trials.
Independent Auditors' Report, page F-2
30.We note that the audit report references Canadian generally accepted auditing standards
and does not conform to the format required by PCAOB AS 3101. Please revise to include
financial statements that are audited in accordance with the standards of the Public
Company Accounting Oversight Board and a report of your independent registered public
accounting firm that fully complies with the guidance in PCAOB AS 3101.06 through .10
and Article 2 of Regulation S-X. Refer to PCAOB Release No. 2017-001.
31.We reference the disclosure in Note 2 that the consolidated financial statements have been
prepared in accordance with International Financial Reporting Standards (“IFRS”) as
issued by the International Accounting Standards Board (“IASB”). Please have the
auditors revise their report to opine on the financial statements prepared in accordance
with IFRS as issued by the IASB. Refer to 17(c) of Form 20-F.
32.Please revise such that the title of your financial statements is consistent with the exact
title included in the auditors' report.
33.Please have your auditors revise the section “Material Uncertainty Related to Going
Concern” to reference substantial doubt and comply with the guidance in PCAOB AS
FirstName LastNameAllen Davidoff
Comapany NameXORTX Therapeutics Inc.
June 25, 2021 Page 7
FirstName LastName
Allen Davidoff
XORTX Therapeutics Inc.
June 25, 2021
Page 7
2415.12 and .13.
34.The audit report does not present the signature of the audit firm, or state the date since
which they have served as the Company’s auditors. Please revise for these issues in
accordance with Rule 2-02 of Regulation S-X and AS 3101.
Financial Statements
Note 5. Deposits, page F-13
35.Revise to disclose your accounting treatment for deposits paid in connection with the
agreements discussed in the Note, including your accounting and valuation of the shares
issued for the deposit in connection with the private placement. Cite the accounting
literature use
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