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
Allen Davidoff
FirstName LastNameAllen
XORTX Therapeutics Inc. Davidoff
Comapany
August NameXORTX Therapeutics Inc.
2, 2021
August
Page 2 2, 2021 Page 2
FirstName LastName
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
Allen Davidoff
FirstName LastNameAllen
XORTX Therapeutics Inc. Davidoff
Comapany
August NameXORTX Therapeutics Inc.
2, 2021
August
Page 3 2, 2021 Page 3
FirstName LastName
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
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,
FirstName LastNameAllen Davidoff
Division of
Corporation Finance
Comapany NameXORTX Therapeutics Inc.
Office of Life
Sciences
August 2, 2021 Page 4
cc: Anthony W. Epps
FirstName LastName