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BriaCell Therapeutics Corp.
Response Received
8 company response(s)
Medium - date proximity
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BriaCell Therapeutics Corp.
Response Received
3 company response(s)
Medium - date proximity
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Company responded
2025-04-22
BriaCell Therapeutics Corp.
References: March 24, 2025
BriaCell Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
↓
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
BriaCell Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-03-13
BriaCell Therapeutics Corp.
References: March 8, 2023
BriaCell Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
↓
BriaCell Therapeutics Corp.
Response Received
13 company response(s)
High - file number match
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↓
Company responded
2019-11-27
BriaCell Therapeutics Corp.
References: November 22, 2019
Summary
Generating summary...
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Company responded
2020-03-13
BriaCell Therapeutics Corp.
Summary
Generating summary...
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Company responded
2020-05-15
BriaCell Therapeutics Corp.
Summary
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Company responded
2020-05-27
BriaCell Therapeutics Corp.
Summary
Generating summary...
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Company responded
2020-10-20
BriaCell Therapeutics Corp.
Summary
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Company responded
2020-12-10
BriaCell Therapeutics Corp.
Summary
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Company responded
2020-12-22
BriaCell Therapeutics Corp.
Summary
Generating summary...
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Company responded
2021-01-14
BriaCell Therapeutics Corp.
Summary
Generating summary...
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Company responded
2021-02-02
BriaCell Therapeutics Corp.
Summary
Generating summary...
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Company responded
2021-02-18
BriaCell Therapeutics Corp.
Summary
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Company responded
2021-02-18
BriaCell Therapeutics Corp.
Summary
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Company responded
2021-02-18
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-02-01
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-12-21
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-10-23
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-10-16
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-03-09
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-11-22
BriaCell Therapeutics Corp.
Summary
Generating summary...
BriaCell Therapeutics Corp.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-10-01
BriaCell Therapeutics Corp.
Summary
Generating summary...
↓
Company responded
2019-10-22
BriaCell Therapeutics Corp.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-11 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-11 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-08 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-08 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-06-24 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 377-08120 | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-03-24 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 377-07783 | Read Filing View |
| 2024-01-29 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2024-01-29 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 333-276650 | Read Filing View |
| 2023-03-16 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2023-03-13 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2023-03-08 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-02 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-01 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-01-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-21 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-10 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-23 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-20 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-16 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-05-27 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-05-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-13 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-09 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-27 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-22 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-12 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-10-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-10-01 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-24 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 377-08120 | Read Filing View |
| 2025-03-24 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 377-07783 | Read Filing View |
| 2024-01-29 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | 333-276650 | Read Filing View |
| 2023-03-16 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2023-03-08 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-01 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-21 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-23 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-16 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-09 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-22 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-10-01 | SEC Comment Letter | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-11 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-11 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-08 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-08 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2025-04-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2024-01-29 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2023-03-13 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-06-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-18 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-02-02 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2021-01-14 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-12-10 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-10-20 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-05-27 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-05-15 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-13 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-27 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-11-12 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
| 2019-10-22 | Company Response | BriaCell Therapeutics Corp. | British Columbia, Canada | N/A | Read Filing View |
2025-07-15 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm BriaCell Therapeutics Corp. Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1 July 15, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Alan Campbell Re: BriaCell Therapeutics Corp. (the "Company") Registration Statement on Form S-1 (the "Registration Statement") File No. 333-288562 Ladies and Gentlemen: The Company hereby withdraws its request for an accelerated effective date of the above-referenced Registration Statement to 5:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter. In addition, the Company hereby requests that the effective date of the above-referenced Registration Statement be accelerated to 1:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time pursuant to Rule 461 under the Securities Act of 1933. Once the Registration Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by contacting Christian Lichtenberger, Esq. at (212) 997-0962 or clichtenberger@srfc.law. Very truly yours, /s/ William V. Williams William V. Williams Chief Executive Officer
2025-07-15 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
ThinkEquity
LLC
17
State Street, 41 st Floor
New
York, NY 10004
July
15, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Alan Campbell
Re:
BriaCell
Therapeutics Corp. (the "Company")
Registration
Statement on Form S-1 (the "Registration Statement")
File
No. 333-288562
Ladies
and Gentlemen:
ThinkEquity
LLC ("ThinkEquity") hereby concurs in the request by the Company to withdraw its request for an accelerated effective date
of the above-referenced Registration Statement to 5:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter.
In
addition, ThinkEquity, solely acting as placement agent on a best efforts basis in an offering pursuant to the Registration Statement,
hereby concurs in the request by the Company that the effective date of the above-referenced Registration Statement be accelerated to
1:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such
time pursuant to Rule 461 under the Securities Act of 1933 (the "Securities Act").
ThinkEquity
affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very
truly yours,
ThinkEquity
LLC
/s/
Eric Lord
Eric
Lord
Head
of Investment Banking
2025-07-14 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
ThinkEquity
LLC
17
State Street, 41 st Floor
New
York, NY 10004
July
14, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Alan Campbell
Re:
BriaCell
Therapeutics Corp. (the "Company")
Registration
Statement on Form S-1 (the "Registration Statement")
File
No. 333-288562
Ladies
and Gentlemen:
ThinkEquity
LLC ("ThinkEquity") hereby concurs in the request by the Company to withdraw its request for an accelerated effective date
of the above-referenced Registration Statement to 9:00 a.m. Eastern Time on July 14, 2025, or as soon as practicable thereafter.
In
addition, ThinkEquity, solely acting as placement agent on a best efforts basis in an offering pursuant to the Registration Statement,
hereby concurs in the request by the Company that the effective date of the above-referenced Registration Statement be accelerated to
5:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such
time pursuant to Rule 461 under the Securities Act of 1933 (the "Securities Act").
ThinkEquity
affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very
truly yours,
ThinkEquity
LLC
/s/
Eric Lord
Eric
Lord
Head
of Investment Banking
2025-07-14 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm BriaCell Therapeutics Corp. Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1 July 14, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Alan Campbell Re: BriaCell Therapeutics Corp. (the "Company") Registration Statement on Form S-1 (the "Registration Statement") File No. 333-288562 Ladies and Gentlemen: The Company hereby withdraws its request for an accelerated effective date of the above-referenced Registration Statement to 9:00 a.m. Eastern Time on July 14, 2025, or as soon as practicable thereafter. In addition, the Company hereby requests that the effective date of the above-referenced Registration Statement be accelerated to 5:00 p.m. Eastern Time on July 15, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time pursuant to Rule 461 under the Securities Act of 1933. Once the Registration Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by contacting Christian Lichtenberger, Esq. at (212) 997-0962 or clichtenberger@srfc.law. Very truly yours, /s/ William V. Williams William V. Williams Chief Executive Officer
2025-07-11 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
ThinkEquity
LLC
17
State Street, 41 st Floor
New
York, NY 10004
July
11, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Alan Campbell
Re:
BriaCell
Therapeutics Corp. (the "Company")
Registration
Statement on Form S-1 (the "Registration Statement")
File
No. 333-288562
Ladies
and Gentlemen:
ThinkEquity
LLC ("ThinkEquity") hereby concurs in the request by the Company to withdraw its request for an accelerated effective date
of the above-referenced Registration Statement to 5:00 p.m. Eastern Time on July 10, 2025, or as soon as practicable thereafter.
In
addition, ThinkEquity, solely acting as placement agent on a best efforts basis in an offering pursuant to the Registration Statement,
hereby concurs in the request by the Company that the effective date of the above-referenced Registration Statement be accelerated to
9:00 a.m. Eastern Time on July 14, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such
time pursuant to Rule 461 under the Securities Act of 1933 (the "Securities Act").
ThinkEquity
affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very
truly yours,
ThinkEquity
LLC
/s/
Eric Lord
Eric
Lord
Head of Investment Banking
2025-07-11 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm BriaCell Therapeutics Corp. Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1 July 11, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Alan Campbell Re: BriaCell Therapeutics Corp. (the "Company") Registration Statement on Form S-1 (the "Registration Statement") File No. 333-288562 Ladies and Gentlemen: The Company hereby withdraw its request for an accelerated effective date of the above-referenced Registration Statement to 5:00 p.m. Eastern Time on July 10, 2025, or as soon as practicable thereafter. In addition, the Company hereby requests that the effective date of the above-referenced Registration Statement be accelerated to 9:00 a.m. Eastern Time on July 14, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time pursuant to Rule 461 under the Securities Act of 1933. Once the Registration Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by contacting Christian Lichtenberger, Esq. at (212) 997-0962 or clichtenberger@srfc.law. Very truly yours, /s/ William V. Williams William V. Williams Chief Executive Officer
2025-07-08 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
ThinkEquity
LLC
17
State Street, 41 st Floor
New
York, NY 10004
July
8, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Alan Campbell
Re:
BriaCell Therapeutics
Corp. (the "Company")
Registration Statement
on Form S-1 (the "Registration Statement")
File
No. 333-288562
Filed July 8, 2025
Ladies
and Gentlemen:
ThinkEquity
LLC ("ThinkEquity"), solely acting as placement agent on a best efforts basis in an offering pursuant to the Registration
Statement, hereby concurs in the request by the Company that the effective date of the above-referenced Registration Statement be accelerated
to 5:00 p.m. Eastern Time on July 10, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to
such time pursuant to Rule 461 under the Securities Act of 1933 (the "Securities Act").
ThinkEquity
affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very truly yours,
ThinkEquity LLC
/s/ Eric
Lord
Eric Lord
Head of Investment Banking
2025-07-08 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm July 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Alan Campbell Re: BriaCell Therapeutics Corp. Registration Statement on Form S-1 File No. 333-288562 Filed July 8, 2025 Ladies and Gentlemen: BriaCell Therapeutics Corp. (the "Company") hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it may become effective at 5:00 p.m. Eastern Time on July 10, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time. Once the Registration Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by contacting Christian Lichtenberger, Esq. at (646) 810-0591 or clichtenberger@srfc.law. Very truly yours, /s/ William V. Williams William V. Williams Chief Executive Officer
2025-06-24 - UPLOAD - BriaCell Therapeutics Corp. File: 377-08120
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 24, 2025 William V. Williams Chief Executive Officer BriaCell Therapeutics Corp. Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1, Canada Re: BriaCell Therapeutics Corp. Draft Registration Statement on Form S-1 Submitted June 18, 2025 CIK No. 0001610820 Dear William V. Williams: 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 Alan Campbell at 202-551-4224 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Benasz Hansotia </TEXT> </DOCUMENT>
2025-04-22 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm ThinkEquity LLC 17 State Street, 41 st Floor New York, NY 10004 April 22, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Tyler Howes and Jason Drory Re: BriaCell Therapeutics Corp. Registration Statement on Form S-1 CIK No. 0001610820 Filed April 22, 2025 Acceleration Request Requested Date: April 24, 2025 Requested Time: 5:00 pm Eastern Time (US) Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933 , as amended (the " Act "), we, as representative of the underwriters, hereby join in the request of BriaCell Therapeutics Corp. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 5:00 pm, Eastern Time (US), on April 24, 2025, or soon as thereafter practicable. Pursuant to Rule 460 under the Act, we wish to advise you that the underwriters will distribute as many copies of the Preliminary Prospectus dated April 22, 2025 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus. The undersigned, as representatives of the underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, ThinkEquity LLC /s/ Eric Lord Eric Lord Head of Investment Banking
2025-04-22 - CORRESP - BriaCell Therapeutics Corp.
CORRESP 1 filename1.htm April 22, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attention: Tyler Howes and Jason Drory Re: BriaCell Therapeutics Corp. Registration Statement on Form S-1 CIK No. 0001610820 Filed April 22, 2025 Ladies and Gentlemen: BriaCell Therapeutics Corp. (the "Company") hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it may become effective at 5:00 p.m. Eastern Time on April 24, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time. Once the Registration Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by contacting Christian Lichtenberger, Esq. at (646) 810-0591 or clichtenberger@srfc.law. Very truly yours, /s/ William V. Williams William V. Williams Chief Executive Officer
2025-04-22 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
April
22, 2025
BY
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Tyler
Howes
Jason
Drory
Re:
BriaCell
Therapeutics Corp.
Draft
Registration Statement on Form S-1
Submitted:
March 12, 2025
CIK
No. 0001610820
Ladies
and Gentlemen:
This
letter is submitted by BriaCell Therapeutics Corp. (the " Company, " " we ," " us ,"
or " our "), in response to the comments of the staff of the Division of Corporation Finance (the " Staff ")
of the Securities and Exchange Commission with respect to the Company's Draft Registration Statement on Form S-1, confidentially
submitted on March 12, 2025 (the " Draft Registration Statement "), as set forth in the Staff's letter, dated
March 24, 2025 (the " Comment Letter "). The Company is concurrently publicly filing the Registration Statement on Form
S-1 (" Registration Statement "), which includes changes to reflect responses to the Staff's comment and other
updates.
For
reference purposes, the text of the Comment Letter has been reproduced herein with the response below for the numbered comment. For your
convenience, we have italicized the reproduced Staff comment from the Comment Letter. All capitalized terms used and not otherwise defined
herein shall have the meanings set forth in Registration Statement.
Draft
Registration Statement on Form S-1
Cover
Page
1.
Please
revise the graphics appearing on the inside cover of your prospectus to remove any statements concluding that your product candidates
are safe, effective or likely to be approved by the FDA. For example, we note your statements claiming your Bria-IMT candidate has
"remarkable clinical efficacy" and "safety & efficacy data similar or superior to approved breast cancer drugs."
We also note your statement claiming "If hazard ratio (HR) is < 0.6... approved!" and the section titled "What
does the FDA think?" which both improperly imply you will receive approval of your Bria-IMT candidate. Statements that conclude
safety, efficacy or impending FDA approval are improper and premature, as such conclusions are within the sole authority of the FDA
and comparable foreign regulators. In your revisions, please also ensure that your graphics accurately represent your current business
and do not present only the most favorable aspects of your company. Refer to Question 101.02 of the Compliance and Disclosure Interpretations
for Securities Act Forms for further guidance.
Response :
In response to the Staff's comment, the Company has revised the disclosure on the cover page.
We
hope that the Company's response above adequately addresses the Staff's comments. If the Staff has any questions or requires
any additional information, please do not hesitate to contact Christian Lichtenberger at Sichenzia Ross Ference Carmel LLP at (646) 810-0591
or clichtenberger@srfc.law .
Very
truly yours,
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
2025-03-24 - UPLOAD - BriaCell Therapeutics Corp. File: 377-07783
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 24, 2025 William V. Williams Chief Executive Officer BriaCell Therapeutics Corp. Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1 Re: BriaCell Therapeutics Corp. Draft Registration Statement on Form S-1 Submitted March 12, 2025 CIK No. 0001610820 Dear William V. Williams: We have conducted a limited review of your draft registration statement and have the following comment. Please respond to this letter by providing any requested information and by publicly filing your registration statement and non-public draft submission on EDGAR. If you do not believe a comment applies 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 this letter and your filed registration statement, we may have additional comments. Draft Registration Statement on Form S-1 Cover Page 1. Please revise the graphics appearing on the inside cover of your prospectus to remove any statements concluding that your product candidates are safe, effective or likely to be approved by the FDA. For example, we note your statements claiming your Bria- IMT candidate has "remarkable clinical efficacy" and "safety & efficacy data similar or superior to approved breast cancer drugs." We also note your statement claiming "If hazard ratio (HR) is < 0.6... approved!" and the the section titled "What does the FDA think?" which both improperly imply you will receive approval of your Bria- IMT candidate. Statements that conclude safety, efficacy or impending FDA approval are improper and premature, as such conclusions are within the sole authority of the FDA and comparable foreign regulators. In your revisions, please also ensure that your graphics accurately represent your current business and do not present only the March 24, 2025 Page 2 most favorable aspects of your company. Refer to Question 101.02 of the Compliance and Disclosure Interpretations for Securities Act Forms for further guidance. 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. We also remind you that your registration statement must be on file no later than 48 hours prior to the requested effective date and time. 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. Please contact Tyler Howes at 202-551-3370 or Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Christian Lichtenberger, Esq. </TEXT> </DOCUMENT>
2024-01-29 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
January
29, 2024
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Alan Campbell
Re:
BriaCell
Therapeutics Corp.
Registration
Statement on Form S-3
File
No. 333-276650
Filed
January 22, 2024
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), BriaCell Therapeutics
Corp. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to accelerate the effective date of the above-referenced registration statement (the “Registration Statement”)
so as to become effective on Wednesday, January 31, 2024, at 5:00 p.m. Eastern Time, or as soon thereafter as practicable. Once the Registration
Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference Carmel LLP, by calling
Avital Perlman, Esq. at 212-930-9700.
Very
truly yours,
/s/
William V. Williams
William V. Williams
Chief Executive Officer
2024-01-29 - UPLOAD - BriaCell Therapeutics Corp. File: 333-276650
United States securities and exchange commission logo
January 29, 2024
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300, 235 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Registration Statement on Form S-3
Filed January 22, 2024
File No. 333-276650
Dear William V. Williams:
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: Avital Perlman, Esq.
2023-03-16 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
March 16, 2023
Gadi Levin
Chief Financial Officer
BriaCell Therapeutics Corp.
Suite 300 - 235 15th Street
West Vancouver, BC V7T2X1
Re:BriaCell Therapeutics Corp.
Form 10-K for the Fiscal Year Ended July 31, 2022
Filed October 28, 2022
File No. 001-40101
Dear Gadi Levin:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-03-13 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
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March
13, 2023
United
States Securities and Exchange Commission
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Christine Torney and Vanessa Robertson
Re:
BriaCell Therapeutics Corp.
Form
10-K for the Fiscal Year Ended July 31, 2022 Filed October 28, 2022
File
No. 001-40101
Ladies
and Gentlemen:
On
behalf of BriaCell Therapeutics Corp. (the “Company”), please find below our response to the comment raised by the staff
(the “Staff”) of the Securities and Exchange Commission in its letter dated March 8, 2023 relating to the Company’s
Form 10-K for the Fiscal Year Ended July 31, 2022 filed October 28, 2022.
For
your convenience, the Staff’s comment has been restated and is followed by the Company’s response in italics.
Form
10-K for the Fiscal Year Ended July 31, 2022
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Results of Operations
Research
Costs, page 64
1. Please
disclose the costs incurred during each period presented for each of your key research and
development projects. If you do not track your research and development costs by project,
please disclose that fact and explain why you do not maintain and evaluate research and development
costs by project. Provide other quantitative or qualitative disclosure that provides more
transparency as to the type of research and development expenses incurred (i.e. by nature
or type of expense) which should reconcile to total research and development expense on the
Statements of Operations.
Response:
The
Company has a breakdown of research and development expenses by project and by nature for all periods from August 1, 2022. The
Company did not track expenses by project prior to August 1, 2022 as the Company was at a significantly earlier stage in its
clinical and pre-clinical development and we believed that the breakdown of such costs would have been arbitrary and would not
provide a meaningful assessment.
We
are therefore in a position to include quantitative and qualitative analysis of our research and development costs in our January 31,
2023 Form 10-Q, which is also set forth below.
Results
of Operations for the Three Months Ended January 31, 2023 and 2022
Research
and Development Costs
Research
costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory; and (ii) clinical trials and investigational
drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
The
following is a breakdown of our research and development costs by project:
Three months ended January 31,
2023
2022
Clinical trials
$ 1,438,231
$ 635,195
Pre-clinical projects
745,236
599,007
Chemical, Manufacturing and Control Costs (“CMC Costs”)
331,590
178,012
Other
538,300
295,965
$ 3,053,357
$ 1,708,179
Our
clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial. Clinical trial
expenses increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.
Pre-clinical
projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an addition
pre-clinical program (sCD80).
CMC
costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the
investigational product. CMC costs increased in 2023 to support the addition patients in our trials.
Other
costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
expenditure. Other costs increased in 2023 as we investigated additional potential pre-clinical projects.
The
following is a breakdown of our research and development costs by nature of expenses:
Three months ended January 31,
2023
2022
Clinical trial sites and investigational drug costs
$ 1,288,577
$ 1,022,705
Wages and salaries
1,282,441
524,108
Laboratory Rent
48,000
25,800
Supplies
207,061
20,762
Professional fees
2,187
5,351
Insurance product
-
-
Share-based compensation
225,091
109,453
$ 3,053,357
$ 1,708,179
For
the three-month period ended January 31, 2023, total research costs amounted to $3,053,357, as compared to $1,708,179 for the three-month
period ended January 31, 2022. The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical
trials, specifically our Bria-IMT™ trial. Clinical Trials and investigational drug costs increased from $1,022,705 in 2022 to $1,288,577
in 2023. Laboratory costs increase during 2023 as well, including the hiring of additional lab employees which increased from $524,108
in 2022 to $1,282,441 in 2023 and increased supplies from $20,762 in 2022 to $207,061 in 2023. Finally, the increase in share based compensation
(non-cash) expenses, from $109,453 in 2022 to $225,091 in 2023 also contributed to the increase in research and development expenses.
2
Results
of Operations for the Six Months Ended January 31, 2023 and 2022
Research
and Development Costs
Research
costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory; and (ii) Clinical trials and investigational
drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
The
following is a breakdown of our research and development costs by project:
Six months ended January 31,
2023
2022
Clinical trials
$ 3,041,327
$ 960,804
Pre-clinical projects
1,608,402
906,067
CMC Costs
741,608
269,264
Other
917,235
447,679
$ 6,308,572
$ 2,583,815
Our
clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial. Clinical trial
expenses increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.
Pre-clinical
projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an addition
pre-clinical program (sCD80).
CMC
costs include the manufacturing of Bria-IMT™ and Bria-OTS™. CMC costs increased in 2023 to support the additional patients
in our trials.
Other
costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
expenditure. Other costs increased in 2023 as we investigated additional potential pre-clinical projects.
The
following is a breakdown of our research and development costs by nature of expenses:
Six months ended January 31,
2023
2022
Clinical trial sites and investigational drug costs
$ 3,330,516
$ 1,497,780
Wages and salaries
1,998,985
809,648
Laboratory Rent
96,000
55,954
Supplies
300,425
80,391
Professional fees
7,299
28,933
Insurance product
-
1,656
Share-based compensation
575,347
109,453
$ 6,308,572
$ 2,583,815
For
the six-month period ended January 31, 2023, research costs amounted to $6,308,572, as compared to $2,583,815 for the six-month period
ended January 31, 2022. The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical trials,
specifically our Bria-IMT™ trial. Clinical Trials and investigational drug costs increased from $1,497,780 in 2022 to $3,330,516
in 2023. Laboratory costs increase during 2023 as well, including the hiring of additional lab employees which increased from $809,648
in 2022 to $1,998,985 in 2023 and increased supplies from $80,391 in 2022 to $300,425 in 2023. Finally, the increase in share based compensation
(non-cash) expenses, from $109,453 in 2022 to $575,347 in 2023 also contributed to the increase in research and development expenses.
The
following is a breakdown of research and development expenses by project (for the year ended July 31, 2022 only) and by nature for the
year ended July 31, 2022 compared to July 31, 2021.
3
The
following is a breakdown of our research and development costs by project:
Year ended
July 31, 2022
Clinical Trial
$ 3,540,955
Pre-clinical projects
2,076,127
CMC Costs
1,346,810
Other
1,057,598
$ 8,021,489
The
following is a breakdown of our research and development costs by nature of expenses:
Year ended July 31,
2022
2021
Clinical Trials and Investigational drug costs
$ 4,881,940
$ 669,943
Wages and salaries
2,225,050
605,106
Laboratory Rent
138,354
28,031
Supplies
-
4,084
Professional fees
309,992
-
Insurance product
30,590
-
Share-based compensation
-
8,332
$ 8,021,489
$ 2,020,899
***
4
We
acknowledge our responsibility for the accuracy and adequacy for our disclosures notwithstanding any review, comment or action or absence
of action by the Staff.
Should
you have additional questions regarding the information contained herein, please contact our counsel, Avital Perlman at 212-930-9700.
Sincerely,
/s/
Gadi Levin
Gadi
Levin, Chief Financial Officer
cc:
William
V. Williams
Avital
Perlman, Esq.
5
2023-03-08 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
March 8, 2023
Gadi Levin
Chief Financial Officer
BriaCell Therapeutics Corp.
Suite 300 - 235 15th Street
West Vancouver, BC V7T2X1
Re:BriaCell Therapeutics Corp.
Form 10-K for the Fiscal Year Ended July 31, 2022
Filed October 28, 2022
File No. 001-40101
Dear Gadi Levin:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended July 31, 2022
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research Costs, page 64
1.Please disclose the costs incurred during each period presented for each of your key
research and development projects. If you do not track your research and development
costs by project, please disclose that fact and explain why you do not maintain and
evaluate research and development costs by project. Provide other quantitative or
qualitative disclosure that provides more transparency as to the type of research and
development expenses incurred (i.e. by nature or type of expense) which should reconcile
to total research and development expense on the Statements of Operations.
In closing, 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
FirstName LastNameGadi Levin
Comapany NameBriaCell Therapeutics Corp.
March 8, 2023 Page 2
FirstName LastName
Gadi Levin
BriaCell Therapeutics Corp.
March 8, 2023
Page 2
absence of action by the staff.
You may contact Christine Torney at (202) 551-3652 or Vanessa Robertson at (202) 551-
3649 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-06-22 - CORRESP - BriaCell Therapeutics Corp.
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June
22, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Attention:
Tim Buchmiller and Fredrick Philantrope
Re:
Briacell
Therapeutics Corp.
Registration
Statement on Form F-1
File
No. 333-257104
Filed
June 15, 2021
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Briacell Therapeutics
Corp. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to accelerate the effective date of the above-referenced registration statement (the “Registration Statement”)
so as to become effective on Thursday, June 24, 2021, at 5:00 p.m. Eastern Time, or as soon thereafter as practicable. Once the Registration
Statement has been declared effective, please confirm orally that event with our counsel, Sichenzia Ross Ference LLP, by calling
Avital Perlman at 212-930-9700.
Very
truly yours,
/s/
William V. Williams
William
V. Williams
Chief Executive Officer
2021-06-21 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
June 21, 2021
William V. Williams
Chief Executive Officer, President and Director
BriaCell Therapeutics Corp.
Suite 300 – 235 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Registration Statement on Form F-1
Filed June 15, 2021
File No. 333-257104
Dear Dr. Williams:
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 Tim Buchmiller at (202) 551-3635 or Fredrick Philantrope at (202) 551-
6875 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman, Esq.
2021-02-18 - CORRESP - BriaCell Therapeutics Corp.
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February
18, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
BriaCell
Therapeutics Corp.
Registration
Statement on Form F-1
File
No. 333-234292
Acceleration
Request
Requested
Date: February 23, 2021
Requested
Time: 5:00 pm Eastern Time (US)
Ladies
and Gentlemen:
In
connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933,
as amended (the “Act”), we, as representative of the underwriters, hereby join in the request of BriaCell Therapeutics
Corp. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 5:00 pm, Eastern
Time (US), on February 23, 2021, or soon as thereafter practicable.
Pursuant
to Rule 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus
dated February 3, 2021 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution
of the Preliminary Prospectus.
The
undersigned, as representatives of the underwriters, have complied and will comply, and we have been informed by the participating
underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
THINKEQUITY
a division of Fordham Financial
Management, Inc.
By:
/s/
Eric Lord
Name:
Title:
Eric
Lord
Head
of Investment Banking
ThinkEquity
17
State Street, 22nd Floor
A division of Fordham
Financial Management, Inc.
New
York, NY 10004
Member FINRA –
SIPC
Tel:
646-968-9355
2021-02-18 - CORRESP - BriaCell Therapeutics Corp.
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BriaCell
Therapeutics Corp.
Suite
300 – 235 15th Street
West
Vancouver, BC V7T 2X1
February
18, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street N.E.
Washington,
D.C. 20549
Attention:
Ms.
Abby Adams and Mr. Joseph McCann
Re:
BriaCell
Therapeutics Corp.
Registration
Statement on Form F-1
File
No. 333-234292
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended, BriaCell Therapeutics Corp. (the “Company”)
hereby respectfully requests acceleration of the effectiveness of the above-referenced Registration Statement so that such Registration
Statement will become effective as of 5:00 p.m. Eastern Time, February 23, 2021, or as soon as practicable thereafter.
Very
truly yours,
BriaCell
Therapeutics Corp.
By:
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
2021-02-18 - CORRESP - BriaCell Therapeutics Corp.
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1
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BriaCell
Therapeutics Corp.
Suite
300 – 235 15th Street
West
Vancouver, BC V7T 2X1
February
18, 2020
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 15 to Registration Statement on Form F-1
Filed
February 18, 2021
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 15 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 15”). Amendment No. 15 is being filed solely to increase the total offering amount raised
and number of securities offered.
Please
do not hesitate to contact me or our counsel with any questions or comments regarding this correspondence or on Amendment No.
15 filed herewith. Thank you.
Sincerely,
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
cc:
(via
email)
Avital
Perlman, Esq.
Gregory
Sichenzia, Esq.
2021-02-02 - CORRESP - BriaCell Therapeutics Corp.
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February
2, 2021
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Franklin Wyman, Lisa Vanjoske, Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 13 to Registration Statement on Form F-1
Filed
January 15, 2021
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 14 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 14”). Amendment No. 14 is being filed to (1) respond to a comment received from the staff
of the Securities and Exchange Commission (the “Staff”), relating to the above-referenced Amendment No. 13 to the
Registration Statement on Form F-1 and (ii) change the assumed offering price to $4.25 and change the resulting number of units
being offered.
For
the Staff’s convenience, the Staff’s comment has been stated below in bold type, followed by the Company’s response
thereto.
Prospectus
Summary, page 1
1.
We
note that you updated the filing to add financial results for the period ended October 31, 2020. Given the significant
changes in your operating results, which you attribute to “the effects of COVID-19 and lack of funds,” please
revise the summary to address the impact of the pandemic, including without limitation, the impact on your clinical trials.
Response:
The Company has clarified in Amendment No. 14 that the change in operating results referenced above was due to lack of funds,
not to COVID-19. The Company has added language to the prospectus summary on page 10 to explain that the lack of funding has resulted
in a pause in enrolling new patients and has also added language describing the impact of COVID-19. The company has also clarified
on pages 45 and 47 that the slowdown in clinical trials in the relevant periods was due to lack of funds.
Please
do not hesitate to contact me at (212) 930-9700 with any questions or comments regarding this correspondence or on Amendment No.
14 filed herewith. Thank you.
Sincerely,
/s/
Avital Perlman
cc:
(via
email)
Dr.
William V. Williams
Gregory
Sichenzia, Esq.
1185
Avenue of the Americas | 37th Floor | New York, NY | 10036
T
(212) 930 9700 | F (212) 930 9725 | WWW.SRF.LAW
2021-02-01 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
January 29, 2021
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Amendment No. 13 to Registration Statement on Form F-1
Filed January 15, 2021
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended 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.
Amendment No. 13 to Registration Statement on Form F-1
Prospectus Summary, page 1
1.We note that you updated the filing to add financial results for the period ended October
31, 2020. Given the significant changes in your operating results, which you attribute to
"the effects of COVID-19 and lack of funds," please revise the summary to address the
impact of the pandemic, including without limitation, the impact on your clinical trials.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
January 29, 2021 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
January 29, 2021
Page 2
You may contact Franklin Wyman at (202) 551-3660 or Angela Connell at (202) 551-
3426 if you have questions regarding the financial statements and related matters. Please contact
Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman
2021-01-14 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
January
14, 2021
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Franklin Wyman, Lisa Vanjoske, Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 12 to Registration Statement on Form F-1
Filed
December 23, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 13 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 13”). Amendment No. 13 is being filed to (i) include the Company’s financial statements
for the fiscal quarter ended October 31, 2020 and (ii) respond to oral comments received from the staff of the Securities and
Exchange Commission, relating to the above-referenced Amendment No. 12 to the Registration Statement on Form F-1.
Opinion
5.1 and Opinion 5.2 filed with Amendment No. 13 have been revised to remove certain assumptions. Please note that Opinion 5.1
includes an opinion as to the valid issuance of the shares underlying the units.
Please
do not hesitate to contact me at (212) 930-9700 with any questions or comments regarding this correspondence or on Amendment No.
13 filed herewith. Thank you.
Sincerely,
/s/
Avital Perlman
cc:
(via
email)
Dr.
William V. Williams
Gregory
Sichenzia, Esq.
1185
Avenue of the Americas | 37th Floor | New York, NY | 10036
T
(212) 930 9700 | F (212) 930 9725 | WWW.SRF.LAW
2020-12-22 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
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BriaCell
Therapeutics Corp.
Suite
300 – 235 15th Street
West
Vancouver, BC V7T 2X1
December
22, 2020
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Franklin Wyman, Lisa Vanjoske, Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 11 to Registration Statement on Form F-1
Filed
December 10, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 12 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 11”). Amendment No. 12 is being filed to respond to the comment from the staff (the “Staff”)
of the Securities and Exchange Commission received on December 21, 2020, relating to the above-referenced Amendment No. 1` to
the Registration Statement on Form F-1.
For
the Staff’s convenience, the Staff’s comment has been stated below in bold type, followed by the Company’s response
thereto.
Amendment
No. 11 to Registration Statement on Form F-1 Prospectus Summary, page 1
1.
Tell
us why you deleted disclosure throughout the document of the investigator-initiated Phase I/IIa study by Dr. Bhattacharya,
and also deleted the related agreement from the exhibits, formerly Exhibit 10.6. We note results were not anticipated until
2021 and 2022. Tell us if the study has been terminated and, if so, why.
RESPONSE:
The Company has deleted the above referenced disclosure and exhibits because Thomas Jefferson University has cancelled the
study as funding had not been received. The study was never initiated and never recruited or dosed any patients.
Exhibits
2.
It
appears that you deleted the legal opinion, previously filed, from the list of exhibits to the registration statement.
Please include the legal opinion with your next amendment.
RESPONSE:
The Company has included the legal opinions that were previously filed with Amendment No. 12.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me or our counsel with any questions
or comments regarding this correspondence or on Amendment No. 12 filed herewith. Thank you.
Sincerely,
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
cc:
(via
email)
Avital
Perlman, Esq.
Gregory
Sichenzia, Esq.
2020-12-21 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
December 21, 2020
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Amendment No. 11 to Registration Statement on Form F-1
Filed December 10, 2020
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended registration statement and have the following
comments. In one of our comments, we 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.
Amendment No. 11 to Registration Statement on Form F-1
Prospectus Summary, page 1
1.Tell us why you deleted disclosure throughout the document of the investigator-initiated
Phase I/IIa study by Dr. Bhattacharya, and also deleted the related agreement from the
exhibits, formerly Exhibit 10.6. We note results were not anticipated until 2021 and
2022. Tell us if the study has been terminated and, if so, why.
Exhibits
2.It appears that you deleted the legal opinion, previously filed, from the list of exhibits to
the registration statement. Please include the legal opinion with your next amendment.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
December 21, 2020 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
December 21, 2020
Page 2
You may contact Franklin Wyman at (202) 551-3660 or Angela Connell at (202) 551-
3426 if you have questions regarding comments on the financial statements and related
matters. Please contact Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman
2020-12-10 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
BriaCell
Therapeutics Corp.
Suite
300 – 235 15th Street
West
Vancouver, BC V7T 2X1
December
10, 2020
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Franklin Wyman, Lisa Vanjoske, Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 10 to Registration Statement on Form F-1
Filed
October 20, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 11 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 11”). Amendment No. 11 is being filed to respond to the comment from the staff (the “Staff”)
of the Securities and Exchange Commission received on October 22, 2020, relating to the above-referenced Amendment No. 10 to the
Registration Statement on Form F-1.
Amendment
No. 11 also includes the Company’s audited financial statements for the fiscal year ended July 31, 2020, includes minor
updates to the Company’s business description and removes Aegis Capital Corp. as a co-manager.
For
the Staff’s convenience, the Staff’s comment has been stated below in bold type, followed by the Company’s response
thereto.
Amendment
No. 10 to Registration Statement on Form F-1
Cover
Page
1. Your response to prior comment 4 explains that the inability of the underwriters to sell the Common Units and/or Pre-funded Units would have a negative effect on the amount of proceeds that the Company would receive. We further note that Section 1.1.1(ii) of the underwriting agreement indicates that there will be an “initial” offering price. Accordingly, please reconcile your response and the terms of the underwriting agreement with your coverpage disclosurewhich highlights and represents that this is a “firm commitment underwritten offering” that will have an “actual” offering price.
RESPONSE:
The Company has revised the F-1 on page 123 to remove the term “initial” when discussing the offering price and to
remove the following sentence:
“If
all of the units offered by us are not sold at the public offering prices, the representative may change the offering prices and
other selling terms. If we cannot sell all of the units at the public offering prices set forth on the cover page of this prospectus
the proceeds from the offering will be lower. We will inform investors of material changes by filing an amendment to the registration
statement of which this prospectus forms a part. If there are immaterial changes to the number of units sold or the public offering
prices, as permitted by Rule 430A of the Securities Act, these changes will be reflected in the final prospectus.”
The
Company has also revised Section 1.1.1(ii) of the underwriting agreement to remove the term “initial” when discussing
the offering price.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me or our counsel with any questions
or comments regarding this correspondence or on Amendment No. 11 filed herewith. Thank you.
Sincerely,
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
cc:
(via email)
Avital
Perlman, Esq.
Gregory
Sichenzia, Esq.
2020-10-23 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
October 22, 2020
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Amendment No. 10 to Registration Statement on Form F-1
Filed October 20, 2020
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended registration statement and have the following
comment. Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe our comment applies 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 , we may have additional comments. Unless we note otherwise, our
references to prior comments are to comments in our October 15, 2020 letter.
Amendment No. 10 to Registration Statement on Form S-1
Coverpage
1.Your response to prior comment 4 explains that the inability of the underwriters to sell the
Common Units and/or Pre-funded Units would have a negative effect on the amount of
proceeds that the Company would receive. We further note that Section 1.1.1(ii) of the
underwriting agreement indicates that there will be an "initial" offering
price. Accordingly, please reconcile your response and the terms of the underwriting
agreement with your coverpage disclosure which highlights and represents that this is a
"firm commitment underwritten offering" that will have an "actual" offering price.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
October 22, 2020 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
October 22, 2020
Page 2
You may contact Franklin Wyman at (202) 551-3660 or Lisa Vanjoske at (202) 551-
3614 if you have questions regarding the financial statements and related matters. Please contact
Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman
2020-10-20 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
BriaCell
Therapeutics Corp.
Suite
300 – 235 15th Street
West
Vancouver, BC V7T 2X1
October
20, 2020
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Attention:
Franklin Wyman, Lisa Vanjoske, Abby Adams, Joseph McCann
Re:
BriaCell Therapeutics Corp.
Amendment
No. 9 to Registration Statement on Form F-1
Filed
September 18, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby submitting Amendment No. 10 to the Company’s Registration Statement
on Form F-1 (“Amendment No. 10”). Amendment No. 10 revises the number of units offered and offering prices and
reflects the Company’s changes in response to the comments from the staff (the “Staff”) of the Securities
and Exchange Commission, received on October 15, 2020, relating to the above-referenced Amendment No. 9 to the Registration Statement
on Form F-1.
For
the Staff’s convenience, the Staff’s comments have been stated below in bold type, followed by the Company’s
responses thereto. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in Amendment No.
10 and all references to page numbers in such responses are to page numbers in Amendment No. 10.
Amendment
No. 9 to Registration Statement on Form F-1
Cover
Page
1.
We reissue our May 29, 2020 comment. Please revise your references to the “assumed price” and “assumed public
offering price” of $4.64 per Common Unit on the cover page of the prospectus to clarify that this is the midpoint of your
price range. To this end, please also disclose the price range in the first and eighth paragraphs of the cover page to provide
context for the assumed price of $4.64 and to clarify that the actual price will fall within the specified ranges.
RESPONSE:
Amendment No. 10 addresses this comment on the cover page.
2.
We note you have included alternative cover pages and disclosure for the sale of shares offered by the selling shareholders. Please
tell us whether the selling stockholder would have the ability to make sales prior to the closing of the primary offering.
RESPONSE:
The selling stockholder has expressed an intent not sell its shares using the selling stockholder prospectus prior to the closing
of the primary offering or concurrently with the primary offering.
Risk
Factors, page 19
3.
Add a risk factor to highlight the potential conflict of interest that one of the company’s named experts is selling shares
in the offering received in lieu of cash compensation.
RESPONSE:
The Company has added a risk factor to address this comment on page 36 of Amendment No. 10.
Underwriting,
page 123
4.
We note your disclosure that if all the shares are not sold at the initial offering price, the representative may change the offering
price and other selling terms. Please explain to us whether the inability of the underwriters to sell the shares would impact
the amount of proceeds that you receive. Also, tell us how you would inform investors of changes to the offering.
RESPONSE:
The inability of the underwriters to sell the Common Units and/or Pre-funded Units would have a negative effect on the amount
of proceeds that the Company would receive. The Company will inform investors of any material changes to the offering by filing
an amendment to the registration statement. If there are immaterial changes to the number of Common Units and/or Pre-funded Units
sold or the public offering prices, as permitted by Rule 430A of the Securities Act, these changes will be reflected in the final
prospectus. Please see page 123.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me or our counsel with any questions
or comments regarding this correspondence or on Amendment No. 10 filed herewith. Thank you.
Sincerely,
/s/
William V. Williams
William
V. Williams
Chief
Executive Officer
cc:
(via email)
Avital
Perlman, Esq.
Gregory
Sichenzia, Esq.
2020-10-16 - UPLOAD - BriaCell Therapeutics Corp.
United States securities and exchange commission logo
October 15, 2020
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Amendment No. 9 to Registration Statement on Form F-1
Filed September 18, 2020
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended 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.
Amendment No. 9 to Registration Statement on Form F-1
Cover Page
1.We reissue our May 29, 2020 comment. Please revise your references to the "assumed
price" and "assumed public offering price" of $4.64 per Common Unit on the cover page
of the prospectus to clarify that this is the midpoint of your price range. To this end,
please also disclose the price range in the first and eighth paragraphs of the cover page to
provide context for the assumed price of $4.64 and to clarify that the actual price will fall
within the specified ranges.
2.We note you have included alternative cover pages and disclosure for the sale of shares
offered by the selling shareholders. Please tell us whether the selling stockholder would
have the ability to make sales prior to the closing of the primary offering.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
October 15, 2020 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
October 15, 2020
Page 2
Risk Factors, page 19
3.Add a risk factor to highlight the potential conflict of interest that one of the company's
named experts is selling shares in the offering received in lieu of cash compensation.
Underwriting, page 123
4.We note your disclosure that if all the shares are not sold at the initial offering
price, the representative may change the offering price and other selling terms. Please
explain to us whether the inability of the underwriters to sell the shares would impact the
amount of proceeds that you receive. Also, tell us how you would inform investors of
changes to the offering.
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 Abby Adams at (202) 551-6902 or Joseph McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Avital Perlman
2020-05-27 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
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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
May
27, 2020
Re:
BriaCell
Therapeutics Corp.
Amendment
No. 8 to Registration Statement on Form F-1
Filed
May 27, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby filing Amendment No. 8 to its Registration Statement on Form F-1/A (“Amendment
No. 8”). Amendment No. 8 has been revised to reflect i) the change to a reasonable efforts offering on the OTCQB from an
underwritten offering on Nasdaq, ii) maximum gross proceeds of up to $4 million from up to $15.755 million and iii) describe the
new terms of the investor warrant.
Please
do not hesitate to contact our counsel at (212) 930-9700 with any questions or comments regarding this correspondence.
Sincerely,
/s/
William V. Williams
William
V. Williams
cc:
(via email)
Jamieson
Bondarenko
Gadi
Levin
Gregory
Sichenzia, Esq.
Avital
Perlman, Esq.
Aaron
Sonshine
Virgil
Z. Hlus
2020-05-15 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
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
May
15, 2020
Re:
BriaCell
Therapeutics Corp.
Amendment
No. 7 to Registration Statement on Form F-1
Filed
May 18, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby filing Amendment No. 7 to its Registration Statement on Form F-1/ Amendment
No. 7 has been revised to reflect i) recent developments, ii) the Company’s financials for the fiscal quarter ended January
31, 2020 and iii) the assumed public offering price per Common Unit and Pre-funded Unit of $6.33 (the “Offering Price”).
The Offering Price was not determined by any particular formula but rather through negotiations between the Company and the underwriter.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact our counsel at (212) 930-9700 with
any questions or comments regarding this correspondence.
Sincerely,
/s/
William V. Williams
William
V. Williams
cc:
(via email)
Jamieson
Bondarenko
Gadi
Levin
Gregory
Sichenzia, Esq.
Avital
Perlman, Esq.
Aaron
Sonshine
Virgil
Z. Hlus
2020-03-13 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
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
March
13, 2020
Re:
BriaCell
Therapeutics Corp.
Amendment
No. 5 to Registration Statement on Form F-1
Filed
February 21, 2020
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby filing Amendment No. 6 to its Registration Statement on Form F-1. Amendment
No. 6 has been revised to reflect the Company’s responses to the comment letter to the Registration Statement received on
March 6, 2020 from the staff of the Commission (the “Staff”).
For
ease of review, we have set forth below each of the numbered comments of the Staff’s 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 Amendment No. 6 and all references to page numbers in such responses are to page numbers in Amendment No. 6.
Amendment
No. 5 to Registration Statement on Form F-1 dated February 21, 2020
Cover
Page
1.
We
note that you present an assumed initial offering price of $14.40 per Common Unit throughout your prospectus, which is the
upper limit of your price range that you have provided on your prospectus cover page and a 20% discount to the last reported
sale price of your common shares as reported on the OTCQB on February 20, 2020. With a view to disclosure and reference to
the Instructions to Regulation S-K, Item 501(b)(3), please tell us why you have selected this assumed offering price/method.
In this regard, it should be clear whether the underwriter will be pricing the offering at a 20% discount to the current market
price.
Response:
The Company has used a 20% discount to the current market price for the assumed offering price in Amendment No. 6 for illustrative
purposes only. However, the actual public offering price per Common Unit and Pre-funded Unit, as the case may be, will
not be determined by any particular formula but will rather be determined through negotiations between the Company and the
underwriter at the time of pricing and may be at a greater than a 20% discount to the current market price. Therefore, the
assumed public offering prices used throughout the prospectus may not be indicative of the final offering price.
Capitalization,
page 38
2.
Please
provide us an analysis that shows how you determined each of the pro forma adjustments in the Capitalization table and the
calculation of “as adjusted net tangible book value per share after this offering” in the Dilution table. In particular,
confirm the calculation of gross and net proceeds in Canadian dollars that you used to prepare each table. Tell us why you
assume the underwriters exercise their overallotment option in full for the Capitalization table and assume they will not
exercise their overallotment option in the Dilution table.
Response:
The Company respectfully acknowledges the Staff’s comment and has provided the table below, which includes an analysis
of how the Company determined each of the pro forma adjustments in the Capitalization table.
Financial
Statement Captions
Pro
forma adjustments as of October 31, 2019
Explanation
Calculation
Cash,
cash equivalents, and short term investments
$14,157,389
Calculated
as the gross proceeds (US$12.5m) less commissions and expenses (“Net Proceeds”)
A.
Gross Proceeds = $16.5M [being US$12.5 million X 1.316 (the CAD/USD rate as of October 31, 2019) B. Commissions = $1,315,999
[being the underwriter’s commission on the gross proceeds (7%+1%)]
C.
expenses = $976,605 [being the total expenses for the registration of the Company’s common stock (“Registration”)
and the offering of Common Units (“Offering”)
D.
Net Proceeds = A – B - C
Common
Stock
$8,634,414
The
amount included in Common stock is calculated as the relative value of the share being offered in the Common Unit, after calculating
the relative value of the warrant (see below), net of expenses being relating to the Offering.
1.
FV of the warrant based on Black-Scholes options pricing model: US$11.7M (41% of Total value of the Common Unit)
2.
FV of shares being offered: US$16.8M [1,200,768 shares X US$13.95] (59% of Total value of the Common Unit)
3.
Total value of the Common Unit: US$28.5M [1+2]
4.
$8,634,414 = 59% of Gross Proceeds less 59% of Commissions less 59% of expenses relating to the Offering
5.
$6,025,820 = 41% of Gross Proceeds less 41% of Commissions less 41% of expenses relating to the Offering
Warrant
reserve
$6,025,820
The
amount included in the warrant reserve is based on the relative value of the warrant to the share being offered in the
Common Unit, net of expenses relating to the Offering.
The
fair value of the warrants included in the above calculation are based on the Black-Scholes option pricing model with
the following assumptions:
share
price – US$13.95 (being the closing price of the stock prior to the filing) ; exercise price - $13.01 (being 125%
premium to the Unit; expected life – 5 years; annualized volatility – 88.11% (bring the volatility used in
the last options issued by the Company); dividend yield – 0%; risk free rate – 1.436%.
Retained
deficit
$502,845
Calculated
as of the portion of total expenses relating to the Registration. As noted above, the portion relating to the Offering is
set off against Common stock and Warrant reserve.
Total
expenses: $976,605, of which $502,845 relates to the Registration and the balance relates to the Offering.
Registration
expenses include primarily NASDAQ and SEC fees, legal and accounting expense.
Offering
costs relate to legal expenses relating to the underwriter’s counsel, legal costs and underwriter costs (excluding
commissions).
The
following tables includes a calculation of “as adjusted net tangible book value per share after this offering” in
the Dilution table:
Caption
in dilution table
Amount
Calculation
A
Public
offering price per Common Unit
$13.70
Public
offering price US$10.41 X 1.316 (the CAD/USD rate as of October 31, 2019)
B
Historical
net tangible book value per common share as of October 31, 2019
$
(1.95)
Net
working capital as of October 31, 2019 ($1,409,349) divided by the number of common shares outstanding as of October 31, 2019
(721,962)
C
Increase
in as adjusted net tangible book value per common share attributable to the net proceeds from new investors
$8.67
D-B
D
As
adjusted net tangible book value per common share after this offering
$6.72
Proforma
net book value after the Offering ($12,912,526) divided by the total amount of outstanding common shares after the offering
(1,590,017 shares)
E
Dilution
per common share to new investors participating in this offering
$6.98
A-D
In
both the Dilution table and Capitalization table the Company has assumed that the underwriters will not exercise their overallotment.
The Company has revised the Registration Statement in both sections to make this disclosure clearer.
Description
of Business
Overview
of the Company, page 47
3.
We
note your added disclosure that Merck will be providing Keytruda for use in a combination study with Bria-IMT and that Merck
will provide Dr. Bhattacharya with a grant to conduct such study. Please revise to explain whether you have collaboration
or license agreements with Dr. Bhattacharya or Thomas Jefferson University. If so, please describe the material terms of the
relevant agreement and file it as an exhibit to the registration statement. Also revise to indicate whether you have a supply
agreement with Merck for Keytruda and, as applicable, describe the material terms of such agreement and file it as an exhibit
to the registration statement. Also revise your disclosure to explain why the Merck grant is “highly coveted”
and state the dollar amount involved. Refer to Item 601(b)(10) of Regulation S-K.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised pages 5, 12, 47, 53 and 123 to
disclose that i) Merck will supply Keytruda directly to Thomas Jefferson University (“TJU”), ii) the Company does
not have an agreement with Merck for the supply of Keytruda and iii) the Company has entered into a study agreement
with TJU providing for the investigator-initiated Phase I/IIa study by Dr. Bhattacharya, the Company’s supply of Bria-IMT™
to TJU and Dr. Bhattacharya and a budget of $3,049,322.50 which shall be paid by the Company to TJU.
The
Company notes that the FDA and TJU’s internal review board have approved the clinical protocol and that TJU has confirmed
to the Company in writing that TJU has received a grant from Merck for the supply of Keytruda in connection with the study.
The
Company has removed the phrase “highly coveted” from the Registration Statement.
Exhibits
5.
We
note counsel’s statement in the legal opinion filed as Exhibit 5.1 that it has assumed that the Warrants, Pre-funded
Unit Warrants and the Underwriting Warrants, which are governed by and construed in accordance with the laws of the State
of New York, comply with and do not violate the laws of the State of New York. Please also provide an opinion of counsel that
addresses whether the Warrants, Pre-funded Unit Warrants and the Underwriting Warrants are binding obligations of the registrant
under the laws of the State of New York. For guidance, please refer to Section II.B.1.f of Staff Legal Bulletin No. 19.
Response:
The Company respectfully acknowledges the Staff’s comment and has filed an opinion of counsel responsive to this comment.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact our counsel at (212) 930-9700 with
any questions or comments regarding this correspondence.
Sincerely,
/s/
William V. Williams
William
V. Williams
cc:
(via email)
Jamieson
Bondarenko
Gadi
Levin
Gregory
Sichenzia, Esq.
Avital
Perlman, Esq.
Aaron
Sonshine
Virgil
Z. Hlus
2020-03-09 - UPLOAD - BriaCell Therapeutics Corp.
March 6, 2020
William V. Williams
Chief Executive Officer
BriaCell Therapeutics Corp.
Suite 300 – 235 West 15th Street
West Vancouver, BC V7T 2X1
Re:BriaCell Therapeutics Corp.
Amendment No. 5 to Registration Statement on Form F-1
Filed February 21, 2020
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended 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.
Amendment No. 5 to Registration Statement on Form F-1 dated February 21, 2020
Cover Page
1.We note that you present an assumed initial offering price of $14.40 per Common
Unit throughout your prospectus, which is the upper limit of your price range that you
have provided on your prospectus cover page and a 20% discount to the last reported sale
price of your common shares as reported on the OTCQB on February 20, 2020. With a
view to disclosure and reference to the Instructions to Regulation S-K, Item 501(b)(3),
please tell us why you have selected this assumed offering price/method. In this regard, it
should be clear whether the underwriter will be pricing the offering at a 20% discount to
the current market price.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
March 6, 2020 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
March 6, 2020
Page 2
Capitalization, page 38
2.Please provide us an analysis that shows how you determined each of the pro forma
adjustments in the Capitalization table and the calculation of “as adjusted net tangible
book value per share after this offering” in the Dilution table. In particular, confirm the
calculation of gross and net proceeds in Canadian dollars that you used to prepare each
table. Tell us why you assume the underwriters exercise their overallotment option in full
for the Capitalization table and assume they will not exercise their overallotment option in
the Dilution table.
Description of Business
Overview of the Company, page 47
3.We note your added disclosure that Merck will be providing Keytruda for use in a
combination study with Bria-IMT and that Merck will provide Dr. Bhattacharya with a
grant to conduct such study. Please revise to explain whether you have collaboration or
license agreements with Dr. Bhattacharya or Thomas Jefferson University. If so, please
describe the material terms of the relevant agreement and file it as an exhibit to the
registration statement. Also revise to indicate whether you have a supply agreement with
Merck for Keytruda and, as applicable, describe the material terms of such agreement and
file it as an exhibit to the registration statement. Also revise your disclosure to explain
why the Merck grant is "highly coveted" and state the dollar amount involved. Refer to
Item 601(b)(10) of Regulation S-K.
Exhibits
4.We note counsel's statement in the legal opinion filed as Exhibit 5.1 that it has assumed
that the Warrants, Pre-funded Unit Warrants and the Underwriting Warrants, which are
governed by and construed in accordance with the laws of the State of New York, comply
with and do not violate the laws of the State of New York. Please also provide an opinion
of counsel that addresses whether the Warrants, Pre-funded Unit Warrants and the
Underwriting Warrants are binding obligations of the registrant under the laws of the State
of New York. For guidance, please refer to Section II.B.1.f of Staff Legal Bulletin No.
19.
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
March 6, 2020 Page 3
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
March 6, 2020
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
2019-11-27 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
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
November
27, 2019
Re:
BriaCell
Therapeutics Corp.
Amendment
No. 1 to Registration Statement on Form F-1
Filed
on November 12, 2019
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell Therapeutics
Corp. (the “Company”) is hereby responding to the comment of the Staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) contained in its letter dated November 22, 2019, with respect to the above
referenced filing with the Commission by the Company. For ease of review, we have set forth below the Staff’s comment
in italics, followed by the Company’s responses.
Prospectus
Summary
Phase
I/IIA Combination Study of BRIA-IMT™ with KEYTRUDA®..., page 9
1.
We
note your revisions in response to our prior comment 2. However, your disclosure in this
section suggests that you are continuing your development work of a combination therapy
with Keytruda. Please substantially revise this section to provide proper context regarding
your Phase I/IIa combination studies with Keytruda, including but not limited to: (i)
removing the graphic on page 10 and providing a brief narrative description of the combination
studies conducted to date to the extent you plan to use this data in your Biologics License
Application; (ii) limiting your disclosure regarding the substantial benefits of Keytruda
to the extent you are not pursuing approval of this combination; (iii) explaining that
you do not have an agreement with Merck for the supply of Keytruda and (iv) disclosing
that you have discontinued studying the combination of Bria-
IMT™
with Keytruda.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the F-1 on pages 10, 46, 52, 64 and 67
to respond to the comment.
Please do not hesitate
to contact the undersigned with any questions or comments regarding this correspondence.
Sincerely,
/s/
William V. Williams
William
V. Williams
cc:
(via email)
Jamieson
Bondarenko
Gadi
Levin
Gregory
Sichenzia, Esq.
Avital
Perlman, Esq.
Aaron
Sonshine
Virgil
Z. Hlus
2019-11-22 - UPLOAD - BriaCell Therapeutics Corp.
November 22, 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.
Amendment No. 1 to Registration Statement on Form F-1
Filed November 12, 2019
File No. 333-234292
Dear Dr. Williams:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our November 7, 2019 letter.
Amendment No. 1 to Registration Statement on Form F-1 filed November 12, 2019
Prospectus Summary
Phase I/IIA Combination Study of BRIA-IMT™ with KEYTRUDA®..., page 9
1.We note your revisions in response to our prior comment 2. However, your disclosure in
this section suggests that you are continuing your development work of a combination
therapy with Keytruda. Please substantially revise this section to provide proper context
regarding your Phase I/IIa combination studies with Keytruda, including but not limited
to: (i) removing the graphic on page 10 and providing a brief narrative description of the
combination studies conducted to date to the extent you plan to use this data in your
Biologics License Application; (ii) limiting your disclosure regarding the substantial
benefits of Keytruda to the extent you are not pursuing approval of this combination;
FirstName LastNameWilliam V. Williams
Comapany NameBriaCell Therapeutics Corp.
November 22, 2019 Page 2
FirstName LastName
William V. Williams
BriaCell Therapeutics Corp.
November 22, 2019
Page 2
(iii) explaining that you do not have an agreement with Merck for the supply of Keytruda
and (iv) disclosing that you have discontinued studying the combination of Bria-
IMT™ with Keytruda.
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
2019-11-12 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
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
November
12, 2019
Re:
BriaCell
Therapeutics Corp.
Registration
Statement on Form F-1 Filed on October 22, 2019
File
No. 333-234292
Ladies
and Gentlemen:
BriaCell
Therapeutics Corp. (the “Company”) is hereby confidentially submitting a Registration Statement on Form F-1 (“Submission
No. 3”). 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”) and a Registration Statement on Form F-1 (the “Registration
Statement”) on October 22, 2019. Submission No. 3 has been revised to reflect the Company’s responses to the
comment letter to the Registration Statement received on November 7, 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. 3 and all references to page numbers in such responses are to page numbers in Submission No. 3.
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.
Response:
The Company respectfully acknowledges the Staff’s comment and has removed the graphics from the Summary presentation
on page 5.
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
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.
Response:
The Company respectfully acknowledges the Staff’s comment and has removed the references to Keytruda and Merck on page
5.
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.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 to discuss the
additional clinical studies that will need to be completed prior to submitting a Biologics License Application as follows:
“BriaCell
plans to continue the Phase I/IIa study of the combination of Bria-IMT™ with INCMGA00012 and epacadostat. Once sufficient
data is available from this study (anticipated to include data on at least 30 patients), BriaCell will determine the design
of a Phase II registration study. BriaCell will negotiate with the FDA to obtain a “Special Protocol Assessment”
(SPA) of the registration study. Under the SPA, the FDA would agree with the design and endpoints of the registration
study and if these endpoints are met, would agree to grant marketing approval of the drug. Completion of the Phase II
registration study will permit BriaCell to submit a Biologics License Application for Bria-IMT.”
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.
Response:
The Company respectfully acknowledges the Staff’s comment and has refiled Exhibit
10.9 to include Attachments One and Two. The Company respectfully acknowledges the Staff’s
comment and has expanded the discussion of the termination provisions of each manufacturing
agreement discussed on page 71. The expanded language is provided in bold font
below:
“On
June 11, 2015, the Company entered into an Agreement for Services with The Regents of the University of California, acting
for and on behalf of its University of California, Davis Health System (“UC Davis”), pursuant to which UC
Davis manufactures Bria-IMT (previously known as BriaVax) at its GMP facility. The Company pays UC Davis
certain hourly rates depending on the specific services provided by UC Davis in connection with its manufacturing of Bria-IMT.
Either Party may terminate this Agreement without cause by giving thirty (30) calendar days written notice to the other.
To effect termination in the event of a material breach of this Agreement, the aggrieved party must provide written notice
of the breach to the offending party and allow the offending party ten (10) business days to cure the breach. If the offending
party does not cure the breach within ten (10) business days, the Agreement will immediately and automatically terminate
on the eleventh (11th) day. This Agreement shall be subject to immediate termination in the event that any Party is excluded
from participation in any federal healthcare or procurement program. Termination or expiration of this Agreement shall
not affect any rights or obligations of the Parties that accrued prior to the date of termination. BriaCell shall pay
UC Davis for all Services rendered and obligations incurred under the Agreement that cannot reasonably be terminated immediately
upon notice of termination up to the date of termination of this Agreement, regardless of the reason for termination.”
“Pursuant
to the Company’s Masters Services Agreement with KBI, dated March 17, 2017, KBI has conducted developmental studies
to derive and optimize a cryopreserved formulation of Bria-IMT (previously known as BriaVax) as a research working
cell bank (RCB) of final drug product doses suitable for cold chain shipment (the “KBI Services”). The Company
pays for the cost of materials, consumables, and third party services, plus an additional 5% fee to compensate KBI for the
cost of purchasing, material handling, inventory and administration and management of third party services necessary for KBI
Biopharma to perform the KBI Services. The Masters Services Agreement with KBI terminates on March 17, 2022. BriaCell
may terminate this Agreement or a Proposal prior to completion of the Proposal by providing sixty (60) days written notice
to KBI Biopharma. In the event that this Agreement or a Proposal is terminated for any reason other than (i) by Client for
KBI Biopharma’s material breach or (ii) by Client, Client shall pay KBI Biopharma upon receipt of invoice all of its
costs for Services performed and expenses incurred or irrevocably obligated related to the Proposal and wind down of activities,
plus, as liquidated damages and not as a penalty, an amount equal to the greater of (a) twenty percent (20%) of the cost of
the Services not yet performed as of the effective date of termination for any Proposal terminated; or (b) the amounts due
for cancellation or postponement of any manufacturing runs scheduled within 180 days of the termination. In the event of a
material breach of this Agreement by a Party that is not cured within thirty (30) days of written notice of such breach by
the non-breaching Party, the non-breaching Party may terminate this Agreement or a Proposal immediately upon written notice.
Upon such termination, KBI Biopharma will promptly scale down the affected portion of the Proposal and use its reasonable
commercial efforts to avoid (or minimize, where non-cancellable) additional expenses. It is understood between the Parties
that KBI Biopharma will incur substantial costs for reservations of resources and planning in order to undertake the provision
of Services. Therefore, in the event of termination by KBI Biopharma, Client shall pay KBI Biopharma upon receipt of invoice
all of its costs incurred or irrevocably obligated related to the Proposal and wind down of activities, plus, as liquidated
damages and not as a penalty, an amount equal to the greater of (a) fifty percent (50%) of the cost of the Services not yet
performed as of the effective date of termination for any Proposal terminated; or (b) the amounts due for cancellation or
postponement of any manufacturing runs scheduled within 180 days of the termination. In the event of termination
by Client, Client’s sole remedy shall be a reduction in the total contract price for the Services in an amount equal
to the difference between: (i) the total contract price for the Proposal; and, (ii) the price of the Services properly performed.
This Agreement may also be terminated upon written notice by a Party in the event: (i) the other Party voluntarily enters
into bankruptcy proceedings; (ii) the other Party makes an assignment for the benefit of creditors; (iii) a petition is filed
against the other Party under a bankruptcy law, a corporate reorganization law, or any other law for relief of debtors or
similar law analogous in purpose or effect, which petition is not stayed or dismissed within thirty (30) days of filing thereof;
or (iv) the other Party enters into liquidation or dissolution proceedings or a receiver is appointed with respect to any
assets of the other Party, which appointment is not vacated within one hundred and twenty (120) days.”
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.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure
on page 73 by including the following language:
“BriaCell
is evaluating Bria-IMT in patients with breast cancer who have failed at least two prior lines of therapy. In this population
there is no approved therapy. Therefore, the development plan for Bria-IMT is an area of high unmet medical need. It is
anticipated that BriaCell will not need to complete Phase 3 clinical trials prior to submitting the marketing application
for Bria-IMT in patients with advanced breast cancer who have failed at least two prior lines of therapy. In this case
a confirmatory Phase 3 evaluation post-marketing will be required. It is anticipated that this would consist of a randomized,
controlled clinical trial of Bria-IMT in combination with immune checkpoint inhibitors compared with best available therapy.
However, this design is subject to negotiation with the FDA.”
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.
Response: The Company respectfully
acknowledges the Staff’s comment. BriaCell is developing a whole cell immunotherapy
derived from a genetically modified breast cancer cell line designated SV-BR-1-GM. In
prior years, SV-BR-1-GM has been referred to as BriaVax™. However, during clinical
evaluation, some of our investigators requested that we not refer to our therapy as a
vaccine as this was confusing to patients who thought vaccines only work to prevent disease.
Therefore, we changed the name from BriaVax to Bria-IMT (with IMT standing for immunotherapy).
This has been clarified where the term BriaVax™ has been used, such as on pages
44, 71 and 123, except in historical documents which used this term.
We
hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (212) 906-1281
with any questions or comments regarding this correspondence.
Sincerely,
/s/
William V. Williams
William
V. Williams
cc:
(via email)
Jamieson
Bondarenko
Gadi
Levin
Gregory
Sichenzia, Esq.
Avital
Perlman, Esq.
Aaron
Sonshine
Virgil
Z. Hlus
2019-11-08 - UPLOAD - BriaCell Therapeutics Corp.
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
2019-10-22 - CORRESP - BriaCell Therapeutics Corp.
CORRESP
1
filename1.htm
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
2019-10-01 - UPLOAD - BriaCell Therapeutics Corp.
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