SEC Comment Letter for BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820) (BCTX) — Oct 1, 2019
BriaCell Therapeutics Corp. (BCTX, BCTXL, BCTXZ) (CIK 0001610820)
Date: Oct. 1, 2019 · CIK: 0001610820 · Accession: 0000000000-19-014114
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September 26, 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.
Draft Registration Statement on Form F-1
Submitted August 30, 2019
CIK No. 0001610820
Dear Dr. Williams:
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 submitted August 30, 2019
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.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 2
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.
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.
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.
5.Please revise to explain at first use 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.
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.
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
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 3
FirstName LastNameWilliam V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 3
appropriate to compare the data across trials.
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.
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.
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.
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.
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.
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.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 4
FirstName LastNameWilliam V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 4
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™."
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.
Competition, page 56
17.Please 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.
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.
Available Clinical Data for Treatment with the Bria-IMT™ Regimen, page 63
20.Please revise your disclosure concerning the three "Proof of Concept" clinical trials to
indicate when and where each trial was conducted. To the extent the testing was
conducted in the United States, indicate whether the trials were subject to FDA approved
protocols or advise.
21.In your discussion of the three proof of concept trials conducted to date, please revise your
disclosure to specify the primary and secondary endpoints of the different trials, the
results as they relate to the endpoints and any statistical analysis that was done. With
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 5
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 5
respect to the median overall survival data, please provide a comparison to the median
overall survival data for untreated patients. Please also disclose the number of patients
who experienced partial and complete responses to the treatment. In addition, with
respect to the third proof of concept trial, please revise your disclosure to specify that the
treatment regimen included pre-treatment with low-dose cyclophosphamide and post-
treatment inoculation of interferon-alpha-2b.
22.We note your disclosure that most patients who dropped out did so due to worsening of
their underlying disease. Please disclose how many people in each study dropped out and
at what point in time they dropped out.
23.Please revise the first chart on page 10 to clarify that the tumor shrinkage and biological
response columns are representative of the number of patients who experienced tumor
shrinkage and biological response rather than the percentage of tumor shrinkage and
biological response for each type of patient.
24.Please define and discuss the significance of the term "delayed-type hypersensitivity
response."
Protein Kinase C Delta (PKC) Inhibitors, page 64
25.Please substantially revise this section to (i) define scientific terms such as PKC, RAS,
TGF and TGF, (ii) describe the PKC inhibitor that you plan to develop and the results of
preclinical studies you have done to date, (iii) provide additional narrative context for
each of the graphics in this section such that investors do not need to read the articles that
are cited to understand the significance of the graphics and (iv) explain the significance of
the measurements (e.g. % control OD value, absorbance 490 nm, etc.) used for each of the
graphs.
26.Please explain why your disclosure on page 66 states that "PKC inhibitor reduces tumor
burden in a human lung cancer model (lower is better)," but the chart above it shows that
tumor volume increases with treatment. Please also include the unit of measurement for
tumor volume.
27.In the graph labelled (B) on page 68, please explain why the percent survival rate with the
vehicle is only measured as of one day as opposed to over a period of time.
Clinical Trials, page 69
28.Please expand your disclosure regarding the Phase I/IIa combination study of Bria-IMT™
with pembrolizumab to provide details regarding the study, including the number of
patients you plan to enroll in the study, patient eligibility requirements, primary and
secondary endpoints and the estimated completion date.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 6
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 6
KEYTRUDA® (pembrolizumab), page 71
29.Please tell us whether you are party to any agreements with Merck for the supply of
Keytruda, and if so, please disclose the material terms of the agreement and file it as an
exhibit to the registration statement. Alternatively, please tell us why you do not believe
this is required. See Item 601(b)(10) of Regulation S-K.
Completed Proof of Concept Trials, page 72
30.It appears that the disclosures on pages 18-20 and 72-74 are identical to the disclosures on
pages 9-10 and 63-64, except for the results in the second chart separating patients by
DTH response. Please remove any duplicative disclosure or advise.
License Agreements, page 75
31.Please expand your disclosure to discuss the material terms of the License Agreement
between Sapientia and Faller-Williams Technology, including rights and obligations,
payment terms such as up-front payment, milestone payments and royalties, and term and
termination provisions.
Manufacturing, page 78
32.Please describe the material terms of any agreements with the University of California,
Davis Health System and with KBI Biopharma, Inc. and file them as exhibits to the
registration statement. Alternatively, please tell us why you do not believe this is
required. See Item 601(b)(10) of Regulation S-K.
Employment Agreements with Executive Officers and Significant Employees, page 103
33.Please file the consulting agreement with Mr. Gadi Levin as an exhibit to the registration
statement pursuant to Item 601(b)(10)(iii)(A), or tell us why you do not believe this is
required.
Independent Auditors' Report, page F-1
34.Please obtain and file a revised audit report from your independent accountant that
complies with the format and language required in PCAOB Auditing Standard 3101. The
report of the independent accountant should include a statement that the audit was
conducted "in accordance with the standards of the Public Company Accounting
Oversight Board (United States)" or tell us why no revision is necessary.
2. Basis of Presentation, page F-6
35.On page 39, you appear to have asserted that adoption of new or revised accounting
standards can be delayed under Section 107 of the JOBS Act. Please explain your
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
September 26, 2019 Page 7
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
September 26, 2019
Page 7
consideration of this guidance for emerging growth companies that report under IFRS.
9. Share-Based Compensation, page F-22
36.You do not specify the vesting terms of all options granted, for example, the 3.4 million
options described on page F-23. Please revise the disclosure as necessary.
14. Research and Development Costs, page F-28
37.Please provide us a summary of the material terms governing the contractual
arrangements described on page 128 and listed in the Exhibits section, as well as