SEC Comment Letter for BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820) (BCTX) — Nov 8, 2019
BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820)
Date: Nov. 8, 2019 · CIK: 0001610820 · Accession: 0000000000-19-015343
AI Filing Summary & Sentiment
File numbers found in text: 333-234292
Show Raw Text
November 7, 2019
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Registration Statement on Form F-1
Filed October 22, 2019
File No. 333-234292
Dear Dr. Williams:
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. Unless we note
otherwise, our references to prior comments are to comments in our September 26, 2019 letter.
Registration Statement on Form F-1 filed October 22, 2019
Prospectus Summary
Overview of the Company, page 5
1.We note your revisions in response to prior comment 3; however, your revised Summary
presentation includes graphics concerning proposed mechanisms of action that are highly
detailed, reliant on complex scientific terminology, and repetitive of graphics presented in
your Business section. Accordingly, please revise your Summary presentation to remove
these graphics or advise.
2.We note your revisions in response to prior comment 4. Your disclosure in the seventh
paragraph on page 5 indicates that your development work is now focused on a
combination therapy involving your product and Incyte Corporation's PD-1 inhibitor
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
November 7, 2019 Page 2
FirstName LastNameWilliam V. Williams
BriaCell Therapeutics Corp.
November 7, 2019
Page 2
pursuant to a collaboration and supply agreement. If so, please revise the third and
seventh paragraphs on page 5 to remove references to Keytruda and Merck. To the extent
that you are actively pursuing development of a combination therapy using Keytruda and
wish to highlight it in your Summary, the Summary should clarify whether you have a
license and/or collaboration/supply agreement with Merck, or whether you will need such
agreement(s) to commercialize a combination therapy using Keytruda.
Products/Pipeline, page 5
3.We note that you will need to complete your Phase I/IIa study and additional clinical
studies before the FDA determines whether your product candidate will be approved for
commercial sale. Please revise your disclosure to discuss the additional clinical studies
that will need to be completed prior to submitting a Biologics License Application.
Description of Business
Manufacturing, page 72
4.We note your response to our prior comment 32. Please also expand your disclosure on
page 72 to discuss the termination provisions of each agreement. In addition, please refile
Exhibit 10.9 to include Attachments One and Two.
Government Regulation, page 72
5.We note your revised disclosure on page 74 that in some cases, FDA will grant
preliminary marketing authorization for drugs treating areas of unmet medical need based
on Phase 2 clinical trials and that in this case, they will also require confirmatory Phase 3
evaluation post-marketing. Please revise your disclosure to clarify whether you will need
to complete Phase 3 clinical trials prior to submitting your marketing application and to
describe what the Phase 3 evaluation post-marketing will entail.
Material Agreements, page 122
6.We note that many of your material agreements relate to conducting clinical studies of a
product candidate called BriaVaxTM. Please tell us the significance of BriaVaxTM to your
business operations and why there is no disclosure relating to it in the discussion of your
product candidates.
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.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
November 7, 2019 Page 3
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
November 7, 2019
Page 3
You may contact Franklin Wyman at (202) 551-3660 or Lisa Vanjoske at (202) 551-3614
if you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at (202) 551-6553 or Joseph McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman