SEC Company Response from BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820) (BCTX) — Oct 22, 2019
BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820)
Date: Oct. 22, 2019 · CIK: 0001610820 · Accession: 0001493152-19-015841
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BriaCell
Therapeutics Corp.
Suite
300 – 235 West 15th Street
West
Vancouver, BC V7T 2X1
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Irene Paik, Joseph McCann, Franklin Wyman and Lisa Vanjoske
October
22, 2019
Re:
BriaCell
Therapeutics Corp.
Draft
Registration Statement on Form F-1 Submitted August 30, 2019
CIK
No. 0001610820
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby confidentially submitting a Registration Statement on Form
F-1 (“Submission No. 2”). The Company previously submitted a Draft Registration Statement on Form F-1
on a confidential basis pursuant to Title I, Section 106 under the Jumpstart Our Business Startups Act with the Securities and
Exchange Commission (the “Commission”) on August 30, 2019 (the “Draft Submission”).
Submission No. 2 has been revised to reflect the Company’s responses to the comment letter to the Draft Submission received
on September 26, 2019 from the staff of the Commission (the “Staff”).
For
ease of review, we have set forth below each of the numbered comments of your letter in bold type followed by the Company’s
responses thereto. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in Submission
No. 2 and all references to page numbers in such responses are to page numbers in Submission No. 2.
Cover
Page
1.
Your
coverpage highlights that you are “in the process of applying” to have your common stock and warrants listed on
the Nasdaq Capital Market and your disclosure on page 112 notes that you might “consummate and close this offering without
a listing approval letter from the Nasdaq Capital Market.” To the extent that the offering will close without a Nasdaq
listing, please (i) revise the coverpage to remove reference to a Nasdaq listing, and (ii) confirm to us that you will register
one or more classes of securities pursuant to Section 12(g) of the Exchange Act or, alternatively, add appropriate risk factor
disclosures concerning the lack of a Section 12 reporting obligation.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on the inside coverpage and page 112 to clarify that listing of the common stock and warrants on the Nasdaq Capital Market is a condition to closing
the offering.
2.
With
reference to Instruction 1 to Regulation S-K, Item 501(b)(3), please tell us whether you plan to revise the coverpage to add
a price range.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on the coverpage to add a price
range.
Prospectus
Summary
Overview
of the Company, page 5
3.
Your
summary should be a brief overview of the key aspects of the offering and should not include a lengthy and detailed description
of your business and strategy or include highly technical terminology. Refer to Item 503(a) of Regulation S-K and Note 4 to
Rule 421(b) under the Securities Act, as amended. We note that your Summary extends over 20 pages in length and duplicates
many of the technical disclosures and graphics concerning trials and mechanisms of action that are presented in your Business
section. In addition, your extensive use of footnotes is not appropriate to a Summary presentation. Accordingly, please substantially
revise the Summary presentation to focus on key aspects and also balance this presentation by including discussion of the
most significant business and offering risks.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the Summary to focus on key aspects of the
Company’s business and discuss the most significant business and offering risks.
4.
Please
revise the second and third paragraphs on page 1 to remove stock exchange, ticker symbols and market capitalization information
for Merck and Incyte. Also, revise the second paragraph to clarify your statement concerning “launching combination
therapy.” In this regard, it should be clear from your disclosure whether clinical work or product commercialization
is commencing in the near term.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to address
the comment.
2
5.
Please
revise to explain at first use the terms “off the shelf” and “personalized immunotherapy.”
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to explain the
terms “off the shelf” and “personalized immunotherapy”.
Bria-IMT™,
page 5
6.
We
note that your discussion of Bria-IMT highlights positive efficacy, safety and tolerability data. Accordingly, please revise
the first paragraph under the heading to place this data into context by clarifying, if true, that “proof of concept”
data is preliminary in nature and that you will need to complete your Phase I/IIa study and additional clinical studies before
FDA assesses the efficacy, safety and tolerability of this product candidate and determines whether it will be approved for
commercial sale.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to add the
requested language.
7.
We
note your disclosure on page 55 that Bria-IMT’s indication will be for the treatment of patients with metastatic breast
cancer who have failed at least two lines of therapy. Please revise your disclosure to note this information in the Prospectus
Summary.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to add the
requested language.
8.
Please
revise the third bullet point under the caption “Positive Proof of Concept” to provide support for your conclusion
that the data is “impressive.” In your response, please also provide us with objective support for your statement
that the data is “similar to, or superior to” other approved breast cancer drugs when they were at a similar development
stage. In your response, please tell us whether there were any material differences in the patient populations or trial protocols,
and if so, why you nonetheless believe it is appropriate to compare the data across trials.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to remove
any reference to “impressive” data or any direct comparison to other drugs. Instead, the data itself has been
more objectively presented. Thus, comparison to other patient populations is no longer relevant.
3
Corporate
Background, page 21
9.
Please
revise to discuss the reverse takeover transaction referenced on page F-21 and the corporate restructuring referenced on page
49, or advise.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure
on page 14 to discuss the referenced corporate restructuring. The reverse takeover
transaction occurred in November 2014 and was referenced in the Company’s financial
statements for the year ended July 31, 2018 with respect to certain shares that were
held in escrow as a result of the reverse takeover. As there are no longer any shares
held in escrow, the Company has not referenced the reverse takeover transaction in its
financial statements for the year ended July 31, 2019.
Implications
of Being an “Emerging Growth Company” and a Foreign Private Issuer, page 22
10.
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.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that, once available, it will supplementally
provide the Staff with copies of additional graphics and artwork it intends to use.
11.
We
note your statement, “We currently report and will continue to report under the Securities Exchange Act of 1934.”
It does not appear that you have been a reporting company under the Securities Exchange Act. Please revise your disclosure
as appropriate.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 15.
Summary
Financial Data, page 25
12. It
does not appear that any amounts in this table are in thousands as stated. Please revise
the disclosure as necessary.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 18.
Use
of Proceeds, page 44
13. We
note that you intend to use $4,000,000 of the net proceeds from this offering for clinical
trials of Bria-IMT™ and $1,200,000 for initial clinical trials of Bria-OTS™.
Please revise your disclosure in this paragraph to specify the stage of development you
plan to achieve for each listed product candidate with these allocated funds. To the
extent material amounts of other funds are necessary to accomplish the specified purposes,
state the amounts and sources of such other funds needed for each specified purpose.
Refer to Item 3.C.1 of Form 20-F.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 37 to specify the
stage of development it plans to achieve for each listed product candidate with the $4,000,000 and $1,200,000 of allocated funds.
At the present time, the Company does not believe that additional funds would be necessary to achieve these purposes.
4
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates, page 49
14. Please
explain how the absence of an active trading market for your common shares listed on
OTCQB and TSXV, as stated on page 38, affected your determination of share compensation
expense, as well as the extent to which the share price amounts disclosed in Notes 8
and 9 may have differed from values determined by an independent valuation firm. In addition,
once you have an estimated offering price range, please explain to us the reasons for
any differences between recent valuations of your common shares leading up to the planned
offering and the midpoint of your estimated offering price range. This information will
help facilitate our review of your accounting for equity issuances, including stock compensation.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the risk factor on page 31 to more accurately
describe that there is an active market for the common stock on the TSXV. As such, the Company believes that it is appropriate
to the use the trading price of the common stock to determine share based compensation expense. Once there is an estimated offering
price range, the Company will explain the reasons for any differences, if any, between recent valuations of the common shares
leading up to the planned offering and the midpoint of the estimated offering price range.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Research Cost, page 50
15. You
state that work began on the development of “second generation Bria-IMT™”
during the nine month period ended April 30, 2019. Please revise your disclosure as appropriate
to discuss the development of “second generation Bria-IMT™.”
Response:
The Company respectfully acknowledges the Staff’s comment. The phrase “second generation Bria-IMTTM”
refers to Bria-OTSTM. The Company has removed references to “second generation Bria-IMTTM” in
the Registration Statement.
Liquidity
and Capital Resources, page 53
16. Please
substantially revise your disclosure in this section to address the requirements of Item
5.B of Form 20-F.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 46 to provide the
information required by Item 5.B of Form 20-F.
5
Competition,
page 56
17. Please
define “CTCs/CAMLs” where first used.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 52 to define “CTCs/CAMLs”
where first used.
Description
of Business
Products/Pipeline,
page 59
18. We
note your disclosure throughout the prospectus suggesting that your product candidate
is safe or effective, such as “impressive Phase IIa efficacy data,” “an
outstanding safety and tolerability profile,” “the patients for which Bria-IMT
immunotherapy was highly effective” and “regulatory review of effective novel
therapies such as Bria-IMT™.” Safety and efficacy determinations are solely
within the authority of the FDA and comparable regulatory authorities. Please revise
your prospectus disclosure to remove all references to your product candidates as being
safe and effective, including preliminary indications of efficacy. You may present the
objective results of trials and any discussion of preliminary results should be sufficiently
balanced with a disclosure of the preliminary nature of such results.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure throughout the Registration Statement
as requested by the comment above.
Bria-OTS™
Immunotherapy Covers ~99% of the Breast Cancer Population, page 61
19. Please
disclose how you determined that Bria-OTS™ would cover 99% of the breast cancer
population and how many variations of Bria-OTS would have to be pre- manufactured in
order to cover this percentage of the population.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 56 and 57.
Available
Clinical Data for Treatment with the Bria-IMT™ Regimen, page 63
20. Please
revise your disclosure concerning the three “Proof of C