Loaded from persisted store.
Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
↓
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-03-07
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2025-03-07
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-03-04
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-02-20
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2025-02-26
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-12-21
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2022-12-21
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-09
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2022-08-10
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-15
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2022-04-15
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-02-27
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2020-03-04
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-09-10
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2019-09-10
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2018-06-13
Edesa Biotech, Inc.
Summary
Generating summary...
↓
SEC wrote to company
2018-06-14
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-05-01
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2018-05-07
Edesa Biotech, Inc.
References: May 1, 2018
Summary
Generating summary...
↓
Company responded
2018-05-09
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-09-23
Edesa Biotech, Inc.
Summary
Generating summary...
↓
Company responded
2016-09-26
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-08-06
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-14
Edesa Biotech, Inc.
Summary
Generating summary...
Edesa Biotech, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-01
Edesa Biotech, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-05 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 333-288966 | Read Filing View |
| 2025-03-07 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-03-07 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 333-285539 | Read Filing View |
| 2025-03-04 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 001-37619 | Read Filing View |
| 2025-02-26 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-02-20 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 001-37619 | Read Filing View |
| 2022-12-21 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-12-21 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-10 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-09 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-04-15 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-04-15 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-04 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2020-02-27 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2019-09-10 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2019-09-10 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-06-14 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-06-13 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-09 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-07 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-01 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2016-09-26 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2016-09-23 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-08-06 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-05-14 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-03-01 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-30 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 333-288966 | Read Filing View |
| 2025-03-07 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 333-285539 | Read Filing View |
| 2025-03-04 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 001-37619 | Read Filing View |
| 2025-02-20 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | 001-37619 | Read Filing View |
| 2022-12-21 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-09 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-04-15 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2020-02-27 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2019-09-10 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-06-14 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-01 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2016-09-23 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-08-06 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-05-14 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2012-03-01 | SEC Comment Letter | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-05 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-03-07 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-02-26 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-12-21 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-08-10 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2022-04-15 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2020-03-04 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2019-09-10 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-06-13 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-09 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2018-05-07 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2016-09-26 | Company Response | Edesa Biotech, Inc. | British Columbia, Canada | N/A | Read Filing View |
2025-09-05 - CORRESP - Edesa Biotech, Inc.
CORRESP 1 filename1.htm Edesa Biotech, Inc. 100 Spy Court Markham, Ontario, Canada L3R 5H6 September 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Edesa Biotech, Inc. Registration Statement on Form S-3 (File No. 333-288966) Filed on July 25, 2025 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Edesa Biotech, Inc. (the " Company ") hereby requests that the above-referenced Registration Statement (the " Registration Statement ") be declared effective by the Securities and Exchange Commission at 4:00 p.m., Eastern Time, on September 9, 2025, or as soon as practicable thereafter. Please call Tracy Buffer of Lowenstein Sandler LLP at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any questions. Very truly yours, EDESA BIOTECH, INC. By: /s/ Peter Weiler Name: Peter Weiler Title: Chief Financial Officer
2025-07-30 - UPLOAD - Edesa Biotech, Inc. File: 333-288966
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 Peter Weiler Chief Financial Officer Edesa Biotech, Inc. 100 Spy Court Markham, Ontario, Canada L3R 5H6 Re: Edesa Biotech, Inc. Registration Statement on Form S-3 Filed July 25, 2025 File No. 333-288966 Dear Peter Weiler: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Tracy F. Buffer </TEXT> </DOCUMENT>
2025-03-07 - CORRESP - Edesa Biotech, Inc.
CORRESP 1 filename1.htm Edesa Biotech, Inc. 100 Spy Court Markham, Ontario, Canada L3R 5H6 March 7, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Edesa Biotech, Inc. Registration Statement on Form S-3 (File No. 333-285539) Filed on March 4, 2025 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Edesa Biotech, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement (the “ Registration Statement ”) be declared effective by the Securities and Exchange Commission at 4:05 p.m., Eastern Time, on March 11, 2025, or as soon as practicable thereafter. Please call Tracy Buffer of Lowenstein Sandler LLP at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any questions. Very truly yours, EDESA BIOTECH, INC. By: /s/ Stephen Lemieux Name: Stephen Lemieux Title: Chief Financial Officer
2025-03-07 - UPLOAD - Edesa Biotech, Inc. File: 333-285539
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 7, 2025 Stephen Lemieux Chief Financial Officer Edesa Biotech, Inc. 100 Spy Court Markham, Ontario, Canada L3R 5H6 Re: Edesa Biotech, Inc. Registration Statement on Form S-3 Filed March 4, 2025 File No. 333-285539 Dear Stephen Lemieux: 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 Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Tracy Buffer </TEXT> </DOCUMENT>
2025-03-04 - UPLOAD - Edesa Biotech, Inc. File: 001-37619
March 4, 2025
Stephen Lemieux
Chief Financial Officer
Edesa Biotech, Inc.
100 Spy Court
Markum, ON L3R 5H6
Canada
Re:Edesa Biotech, Inc.
Form 10-K for Fiscal Year Ended September 30, 2024
File No. 001-37619
Dear Stephen Lemieux:
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
2025-02-26 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Edesa Biotech, Inc.
100 Spy Court, Markham, Ontario L3R 5H6
(289) 800-9600 |
www.edesabiotech.com
February 26, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tracie Mariner
Vanessa Robertson
Re:
Edesa Biotech, Inc.
Form 10-K for Fiscal Year Ended September 30, 2024
File No. 001-37619
Dear Ms. Mariner and Ms. Robertson:
Edesa Biotech, Inc. (the “Company,” “we,” or “our”)
acknowledges receipt of your comment letter (the “Comment Letter”) dated February 20, 2025 from the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “SEC” or the “Commission”) regarding the above-referenced
Form 10-K, as filed on December 13, 2024. As such, set forth below is the Company’s response to the comment contained in the Comment
Letter. To facilitate the Staff’s review, the Company has included the Staff’s comment in bold italics below.
Form 10-K for Fiscal Year Ended September 30, 2024
Management's Discussion and Analysis of Financial Condition and Results
of Operations
Results of Operations, page 44
1.
Considering the significant research and development expenses
you have historically incurred and expect to continue to incur, please provide revised disclosure to be included in future filings to
include more disaggregated disclosures for your research and development expenses. Please address the following to more clearly disclose
the trends experienced during the periods presented:
·
Revise to break out the costs incurred during each period presented by product candidate or therapeutic area.
·
If you do not track your research and development costs by product or therapeutic area, please disclose that fact and separately
quantify the total amount of external costs recognized for each period presented.
·
For all other research and development expenses, provide other quantitative or qualitative disclosure that provides more
transparency as to the type of research and development expenses incurred (i.e. quantify by nature or type of expense). The total
of costs broken out should reconcile to total research and development expense on the Statements of Operations.
Response: The Company acknowledges the Staff’s comment.
The Company respectfully advises the Staff that it tracks research and development expenses as either external research and development
expenses or internal research and development expenses. External research and development expenses include clinical trial costs, contract
manufacturing costs, research and innovation costs, pre-clinical study costs and other development costs that are either incurred for
a specific clinical program or incurred for pre-clinical or early-stage programs. The Company also incurs external research and development
expenses related to general research and development costs that are not related to any specific program.
The Company’s internal research and development costs consist primarily
of compensation and related personnel costs and other general research and development costs that support the entire research and development
group and are not tracked by program. As such, the only research and development costs that the Company tracks by program are external
research and development expenses incurred for a specific program.
Edesa Biotech, Inc.
100 Spy Court, Markham, Ontario L3R 5H6
(289) 800-9600 |
www.edesabiotech.com
The Company intends to include tables similar to those set forth on Exhibit
A hereto in the section titled Results of Operations in Part II, Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations of its Quarterly Report on Form 10-Q for the period ending March 31, 2025, as well as narrative disclosure
accompanying such tables. Because the quarter ending March 31, 2025 has not been completed, the form of the narrative disclosure accompanying
the tables is not set forth on Exhibit A. We will include similar tables in each Quarterly Report on Form 10-Q and Annual Report
on Form 10-K on a prospective basis. Such tables will be included in the section titled Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
Please contact the undersigned if you have any comments or questions regarding
the foregoing. Thank you in advance for your cooperation in connection with this matter.
EDESA BIOTECH, INC.
/s/ Stephen Lemieux
Stephen Lemieux
Chief Financial Officer
cc: Steven M. Skolnick, Esq., Lowenstein Sandler LLP
cc: Tracy Buffer, Esq., Lowenstein Sandler LLP
Edesa Biotech, Inc.
100 Spy Court, Markham, Ontario L3R 5H6
(289) 800-9600 |
www.edesabiotech.com
Exhibit A
The following table summarizes our research and development expenses incurred during the three
months ended March 31, 2025 and 2024, together with the dollar increase or decrease in those items:
(In thousands)
Three Months Ended March 31,
Change
2025
2024
$
Program-specific external costs:
EB06
$
$
EB05
Other development and discovery programs
Total program-specific costs
Non-program specific external costs
Unallocated internal costs
Compensation and related personnel costs
Other expenses
Total unallocated internal costs
—
—
—
Total research and development costs
—
—
—
The following table summarizes our research and development expenses incurred during the six
months ended March 31, 2025 and 2024, together with the dollar increase or decrease in those items:
(In thousands)
Six Months Ended March 31,
Change
2025
2024
$
Program-specific external costs:
EB06
$
$
EB05
Other development and discovery programs
Total program-specific costs
Non-program specific external costs
Unallocated internal costs
Compensation and related personnel costs
Other expenses
Total unallocated internal costs
—
—
—
Total research and development costs
—
—
—
2025-02-20 - UPLOAD - Edesa Biotech, Inc. File: 001-37619
February 20, 2025
Stephen Lemieux
Chief Financial Officer
Edesa Biotech, Inc.
100 Spy Court
Markum, ON L3R 5H6
Canada
Re:Edesa Biotech, Inc.
Form 10-K for Fiscal Year Ended September 30, 2024
File No. 001-37619
Dear Stephen Lemieux:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended September 30, 2024
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 44
Considering the significant research and development expenses you have historically
incurred and expect to continue to incur, please provide revised disclosure to be
included in future filings to include more disaggregated disclosures for your research
and development expenses. Please address the following to more clearly disclose the
trends experienced during the periods presented:
•Revise to to break out the costs incurred during each period presented by product
candidate or therapeutic area.
•If you do not track your research and development costs by product or therapeutic
area, please disclose that fact and separately quantify the total amount of external
costs recognized for each period presented.
For all other research and development expenses, provide other quantitative or
qualitative disclosure that provides more transparency as to the type of research •1.
February 20, 2025
Page 2
and development expenses incurred (i.e. quantify by nature or type of expense).
The total of costs broken out 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 absence of action by the staff.
Please contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at 202-551-
3649 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-12-21 - UPLOAD - Edesa Biotech, Inc.
United States securities and exchange commission logo
December 21, 2022
Kathi Niffenegger
Chief Financial Officer
Edesa Biotech, Inc.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
Re:Edesa Biotech, Inc.
Registration Statement on Form S-3
Filed December 16, 2022
File No. 333-268847
Dear Kathi Niffenegger :
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tracy Buffer
2022-12-21 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Edesa Biotech, Inc.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
December 21, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Edesa Biotech, Inc.
Registration Statement on Form S-3 (File No. 333-268847)
Filed on December 16, 2022
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended, Edesa Biotech, Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission
at 4:05 p.m., Eastern Time, on December 23, 2022, or as soon as practicable thereafter.
Please call Tracy Buffer of
Lowenstein Sandler LLP at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
EDESA BIOTECH, INC.
By: /s/ Kathi Niffenegger
Name: Kathi Niffenegger
Title: Chief Financial Officer
2022-08-10 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Edesa Biotech, Inc.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
August 10, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Edesa Biotech, Inc.
Registration Statement on Form S-3 (File No. 333-266604)
Filed on August 5, 2022
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended, Edesa Biotech, Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission
at 5:00 p.m., Eastern Time, on August 12, 2022, or as soon as practicable thereafter.
Please call Steven M. Skolnick
of Lowenstein Sandler LLP at (646) 414-6947 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
EDESA BIOTECH, INC.
By:
/s/ Kathi Niffenegger
Name: Kathi Niffenegger
Title: Chief Financial Officer
2022-08-09 - UPLOAD - Edesa Biotech, Inc.
United States securities and exchange commission logo
August 9, 2022
Kathi Niffenegger
Chief Financial Officer
Edesa Biotech, Inc.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
Re:Edesa Biotech, Inc.
Registration Statement on Form S-3
Filed August 5, 2022
File No. 333-266604
Dear Ms. Niffenegger:
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 Conlon Danberg at 202-551-4466 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tracy Buffer, Esq.
2022-04-15 - UPLOAD - Edesa Biotech, Inc.
United States securities and exchange commission logo
April 15, 2022
Pardeep Nijhawan
Chief Executive Officer
Edesa Biotech, Inc.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
Re:Edesa Biotech, Inc.
Registration Statement on Form S-1
Filed April 11, 2022
File No. 333-264235
Dear Dr. Nijhawan:
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 Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tracy F. Buffer, Esq.
2022-04-15 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
April 15,
2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re:
Edesa Biotech, Inc.
Registration Statement on Form S-1
File No. 333-264235
CIK No. 0001540159
Acceleration Request
Requested Date:
April 19, 2022
Requested Time:
4:30 PM, Eastern Time
Dear Ladies and Gentlemen:
Pursuant to
Rule 461 under the Securities Act of 1933, as amended, Edesa Biotech, Inc. (the “Company”) hereby requests that
the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange
Commission (the “Commission”) at the “Requested Date” and “Requested Time” set forth above or at such
later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of
the Commission.
Please call
Steven M. Skolnick of Lowenstein Sandler LLP at (646) 414-6947 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
EDESA BIOTECH, INC.
By:
/s/ Kathi Niffenegger
Name:
Kathi Niffenegger
Title:
Chief Financial Officer
2020-03-04 - CORRESP - Edesa Biotech, Inc.
CORRESP 1 filename1.htm Blueprint Edesa Biotech, Inc. 100 Spy Court Markham, Ontario, Canada L3R 5H6 March 4, 2020 United States Securities and Exchange Commission Attention: Ada D. Sarmento Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Edesa Biotech, Inc. (the “Company”) Registration Statement on Form S-1 (the “Registration Statement”) File Number 333-236608 Dear Ms. Sarmento: The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of the effectiveness of the Registration Statement so that such Registration Statement will become effective as of 5:00 P.M. on Friday, March 6, 2020, or as soon thereafter as practicable. Very truly yours, EDESA BIOTECH, INC. By: /s/ Kathi Niffenegger Name: Kathi Niffenegger Title: Chief Financial Officer
2020-02-27 - UPLOAD - Edesa Biotech, Inc.
February 27, 2020
Kathi Niffenegger
Chief Financial Officer
Edesa Biotech, Inc.
100 Spy Court
Markham, ON L3R 5H6 Canada
Re:Edesa Biotech, Inc.
Registration Statement on Form S-1
Filed February 25, 2020
File No. 333-236608
Dear Ms. Niffenegger:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jonathan Friedman, Esq.
2019-09-10 - UPLOAD - Edesa Biotech, Inc.
September 9, 2019
Pardeep Nijhawan
Chief Executive Officer
Edesa Biotech, Inc.
100 Spy Court
Markham, ON L3R 5H6 Canada
Re:Edesa Biotech, Inc.
Registration Statement on Form S-3
Filed August 30, 2019
File No. 333-233567
Dear Dr. Nijhawan:
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 Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jonathan Friedman
2019-09-10 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Blueprint
EDESA BIOTECH, INC.
100 Spy Court
Markham, Ontario, Canada L3R 5H6
September
10, 2019
VIA EDGAR
United
States Securities and Exchange Commission
100 F
Street, N.E.
Washington,
D.C. 20549
Re:
Edesa
Biotech, Inc.
Registration
Statement on Form S-3 (File No. 333-233567)
Acceleration
Request
Requested
Date:
September
12, 2019
Requested
Time:
4:00
p.m. Eastern Time
Ladies
and Gentlemen:
Edesa
Biotech, Inc. (the “Company”) hereby requests that the
above-referenced Registration Statement on Form S-3 (File No.
333-233567) (the “Registration Statement”) be
declared effective at the “Requested Date” and
“Requested Time” set forth above or as soon thereafter
as possible.
Very truly
yours,
EDESA BIOTECH,
INC.
Date: September 10,
2019
By:
/s/ Kathi
Niffenegger
Kathi
Niffenegger
Chief Financial
Officer
2018-06-14 - UPLOAD - Edesa Biotech, Inc.
June 13, 2018
Kathi Niffenegger
Chief Financial Officer
Stellar Biotechnologies, Inc.
332 E. Scott Street
Port Hueneme, California 93041
Re:Stellar Biotechnologies, Inc.
Registration Statement on Form S-1
Filed June 6, 2018
File No. 333-225450
Dear Ms. Niffenegger:
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 Irene Paik at 202-551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Barbara A. Jones - Greenberg Traurig, LLP
2018-06-13 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Stellar Biotechnologies, Inc.
332 E. Scott Street
Port Hueneme, CA 93041
June 13, 2018
United States Securities and Exchange Commission
Attention: Irene Paik
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE: Stellar Biotechnologies, Inc. (the “Company”)
Registration Statement on Form S-1 (the “Registration
Statement”)
File Number 333-225450
Dear Ms. Paik:
The Company hereby
requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of the effectiveness of the
Registration Statement so that such Registration Statement will become effective as of 5:00 P.M. on Friday, June 15, 2018, or
as soon thereafter as practicable.
The Company hereby acknowledges that:
· Should the Securities and Exchange Commission (the “Commission”) or the Staff, acting pursuant to delegated authority,
declare the Registration Statement effective, the Commission is not foreclosed from taking any action with respect to the Registration
Statement;
· The action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration
Statement; and
· The Company may not assert the declaration of effectiveness as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
STELLAR BIOTECHNOLOGIES, INC.
By:
/s/ Kathi Niffenegger
Name: Kathi Niffenegger
Title: Chief Financial Officer
2018-05-09 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Stellar Biotechnologies, Inc.
332 E. Scott Street
Port Hueneme, CA 93041
May 9, 2018
Unites States Securities and
Exchange Commission
Attention: Ada D. Sarmento and Suzanne Hayes
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE: Stellar Biotechnologies, Inc. (the “Company”)
Registration
Statement on Form S-1 (the “Registration Statement”)
File
Number 333-224314
Dear Mses. Sarmento and Hayes:
The Company hereby
requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of the effectiveness of the
Registration Statement that such Registration Statement will become effective as of 5:00 P.M. on Thursday, May 10, 2018, or as
soon thereafter as practicable.
The Company hereby acknowledges that:
· Should the Securities and Exchange Commission (the “Commission”) or the Staff, acting pursuant to delegated authority,
declare the Registration Statement effective, the Commission is not foreclosed from taking any action with respect to the Registration
Statement;
· The action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement
effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration
Statement; and
· The Company may not assert the declaration of effectiveness as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
STELLAR BIOTECHNOLOGIES, INC.
By:
/s/ Kathi Niffenegger
Name: Kathi Niffenegger
Title: Chief Financial
Officer
2018-05-07 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Stellar
Biotechnologies, Inc.
322 E.
Scott Street
Port Hueneme,
California 93041
May 7, 2018
VIA EDGAR
United States Securities and Exchange Commission
Attention: Ada D. Sarmento and Suzanne Hayes
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Stellar Biotechnologies, Inc.
Registration Statement on Form S-1
Filed April 17, 2018
File No. 333-224314
Dear Mses. Sarmento and Hayes,
This letter sets forth the responses of Stellar Biotechnologies,
Inc. (the “Company”) to the comment set forth in your letter dated May 1, 2018, with respect to the above-referenced
Registration Statement on Form S-1. For ease of reference, our response correlates with the Staff’s comment, which we provided
immediately preceding the Company’s response.
Registration Statement on Form S-1
Cover Page
1. Please revise the cover page to provide the date that
the offering will end. Refer to Item 501(b)(8)(iii) of Regulation S-K.
Company Response:
The Company acknowledges the Staff’s comment and notes
that it will revise the outside cover page of the prospectus included in the Company’s Registration Statement on Form S-1
to add a new sentence at the end of the first full paragraph under the pricing table to reflect that the offering is expected to
end on or before May 17, 2018.
If you have any questions regarding this request, please contact
the undersigned at (805) 488-2800 or Barbara Jones of Greenberg Traurig, LLP at (617) 310-6064.
Sincerely,
STELLAR BIOTECHNOLOGIES, INC.
By:
/s/ Kathi Niffenegger
Name:
Kathi Niffenegger
Title:
Chief Financial Officer
2018-05-01 - UPLOAD - Edesa Biotech, Inc.
May 1, 2018
Kathi Niffenegger
Chief Financial Officer
Stellar Biotechnologies, Inc.
332 E. Scott Street
Port Hueneme, CA 93041
Re:Stellar Biotechnologies, Inc.
Registration Statement on Form S-1
Filed April 17, 2018
File No. 333-224314
Dear Ms. Niffenegger:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Registration Statement on Form S-1
Cover Page
1.Please revise the cover page to provide the date that the offering will end. Refer to Item
501(b)(8)(iii) of Regulation S-K.
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
FirstName LastNameKathi Niffenegger
Comapany NameStellar Biotechnologies, Inc.
June 16, 2017 Page 2
FirstName LastName
Kathi Niffenegger
Stellar Biotechnologies, Inc.
May 1, 2018
Page 2
statement.
Please contact Ada D. Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Barbara Jones, Esq.
2016-09-26 - CORRESP - Edesa Biotech, Inc.
CORRESP
1
filename1.htm
Stellar Biotechnologies, Inc.
332 E. Scott Street
Port Hueneme, California 93041
September 26, 2016
By EDGAR
Securities and Exchange Commission
Attention: Suzanne Hayes
Assistant Director
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Stellar Biotechnologies, Inc.
Registration Statement on Form S-3
File No. 333-213654
Dear Ms. Hayes:
Pursuant to Rule 461 under the Securities
Act of 1933, the undersigned registrant (the “Registrant”) hereby respectfully requests that the above-referenced
Registration Statement on Form S-3 be declared effective at 4:00 p.m. (Washington, D.C. time) on Wednesday, September 28, 2016,
or as soon as practicable thereafter. An oral request for acceleration of effectiveness may be made in the future. The Registrant
is aware of its obligations under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended.
In connection with the Registrant’s
request for acceleration of effectiveness of the above-referenced Registration Statement on Form S-3, the Registrant acknowledges
that:
· should the Securities
and Exchange Commission (the “Commission”) or the staff, acting pursuant
to delegated authority, declare the filing effective, it does not foreclose the Commission
from taking any action with respect to the filing;
· the action of
the Commission or the staff, acting pursuant to delegated authority, in declaring the
filing effective, does not relieve the Registrant from its full responsibility for the
adequacy and accuracy of the disclosure in the filing; and
· the Registrant
may not assert staff comments and the declaration of effectiveness as a defense in any
proceeding initiated by the Commission or any person under the federal securities laws
of the United States.
If you have any questions regarding this
request, please contact the undersigned at (805) 488-2800 or Barbara A. Jones of Greenberg Traurig, LLP at (617) 310-6064.
Sincerely,
STELLAR BIOTECHNOLOGIES, INC.
By:
/s/ Kathi Niffenegger
Name: Kathi Niffenegger
Title: Chief Financial Officer
2016-09-23 - UPLOAD - Edesa Biotech, Inc.
Mail Stop 4546 September 23, 2016 Kathi Niffenegger Chief Financial Officer Stellar Biotechnologies, Inc. 332 E. Scott St. Port Hueneme, CA 93041 Re: Stellar Biotechnologies, Inc. Registration Statement on Form S-3 Filed September 16, 2016 File No. 333-213654 Dear Ms. Niffenegger : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Kathi Niffenegger Stellar Biotechnologies, Inc. September 23, 2016 Page 2 Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Jeffrey Gabor at (202) 551 -2544 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Barbara A. Jones , Esq. Greenberg Traurig, LLP
2012-08-06 - UPLOAD - Edesa Biotech, Inc.
August 6, 2012 Via E -Mail Mr. Frank Oates President and Chief Executive Officer Stellar Biotechnologies, Inc. 332 E. Scott Street Port Hueneme, California 93041 Re: Stellar Biotechnologies, Inc. Registration Statement on Form 20 -F Filed February 3, 2012 File No. 000-54598 Dear Mr. Oates : We have completed our review of your filing and related amendments . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing s and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal secur ities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan Daniel Greenspan Legal Branch Chief
2012-05-14 - UPLOAD - Edesa Biotech, Inc.
May 14, 2012
Via E-Mail
Frank Oakes President and Chief Executive Officer Stellar Biotechnologies, Inc. 332 E. Scott Street Port Hueneme, California 93041
Re: Stellar Biotechnologies, Inc.
Registration Statement on Form 20-F Amendment No. 1 filed April 30, 2012
File No. 000-54598
Dear Mr. Oakes:
We have reviewed the amendment to your registration statement filed on April 30, 2012
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 within te n business days 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 re gistration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form 20-F
General
1. Please note that our comments on your recent request for confidential treatment with
respect to certain exhibits will be provided under separate cover. In addition, please note
that we may request additional disclosures in your registration statement as a result of our
review of the exhibits for which you ha ve requested confidential treatment.
2. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please disclose prominently in the beginning of
your registration statement that you are an emerging growth company. In addition,
describe how and when a company may lo se emerging growth company status and
provide a brief description of the exemption from Section 404(b) of the Sarbanes-Oxley
Act of 2002.
Mr. Frank Oakes Stellar Biotechnologies, Inc. May 14, 2012 Page 2
Part I
Item 3 . Key Information
Statement of Capitalization and Indebtedness, page 7
3. It appears that the stockholders’ equity amounts at Fe bruary 28, 2012 should be labeled
November 30, 2011 consistent with your disc losure on page 120. Please revise.
Item 5. Operating and Financial Review and Prospects, page 27
4. Please revise your disclosure to highlight that the financia l information for the periods
ended November 30, 2011 and 2010 are unaudited.
Part III
Item 17. Financial Statements
Consolidated Statements of Income (Loss), Comp rehensive Income (Loss), and Deficit, page 95
5. Based on your revised disclosure in response to prior comment 44, it appears the earnings
(loss) per share prior to the recapitalization should be restated to reflect the equivalent
number of shares received by Stellar CA. Please revise your disclo sure in Note 3, and
explain to us, how the shares issued in the recapitalization were retroactively restated in
the historical financial statements prior to the transaction.
Notes to Consolidated Financial Statements
Note 7. Licensing Rights, page 106
6. Refer to your revised disclosure in res ponse to prior comment 46. Please revise your
disclosure in the application se ctions of the filing to describe all of the significant terms
of your agreements. For example, it appears that you did not disclose the length of each
agreement, any material milestone paym ents, and the termination provisions.
Note 10. Share Capital, page 108
7. We note your response to prior comment 47. It appears that you should revise your
tabular disclosure in Note 10 and Note 16 to arrive at 10,000,000 as the number of shares
outstanding immediately prior to the recapita lization and 6,763,256 as the shares issued
in fiscal 2010 to reflect the historical number of shares of the legal parent upon
recapitalization. Please revise or tell us why your current disclosure is appropriate.
8. Consistent with your revised disclosure in response to prior comment 44 please revise
your disclosure in Note 10 and Note 16 to state that the line item for the net assets of the
parent were recorded at their ca rrying value and not fair value.
Mr. Frank Oakes Stellar Biotechnologies, Inc. May 14, 2012 Page 3
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Securities Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that:
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Don Abbott, Senior
Accountant, at (202) 551-3608, if you have que stions regarding comments on the financial
statements and related matters. Please cont act John Krug, Senior C ounsel, at (202) 551-3862,
Dan Greenspan, Branch Chief, at (202) 551-3623 , or me at (202) 551-3715 with any other
questions.
Sincerely,
/s/ Daniel Greenspan for Jeffrey Riedler
Assistant Director
cc: Mr. Steve Taylor A.B. Korelin & Associates, Inc. 17404 163
rd Place SE
Renton, Washington 98058
Mr. Frank Oakes Stellar Biotechnologies, Inc. May 14, 2012 Page 4
2012-03-01 - UPLOAD - Edesa Biotech, Inc.
February 29, 2012 Via E-Mail Frank Oakes President and Chief Executive Officer Stellar Biotechnologies, Inc. 332 E. Scott Street Port Hueneme, California 93041 Re: Stellar Biotechnologies, Inc. Registration Statement on Form 20-F Filed February 3, 2012 File No. 000-54598 Dear Mr. Oakes: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. Please respond to this letter within te n business days 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form 20-F General 1. Please note that your registration statement will become effective automatically by operation of law 60 days from the date you file d it. Upon effectiveness, you will become subject to the reporting requireme nts of the Exchange Act, even if we have not completed the review process of your filing. To the ex tent this is a voluntary filing, if you do not wish to incur these obligations until all of the following issues are resolved, you should withdraw your registration statement prio r to the sixtieth day and resubmit a new registration statement when you have revised your document. 2. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are appli cable to portions of the filing that we have not cited as examples, please make the appropriate changes in compliance with our comments. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 2 3. Please update the discussion in your prospect us to the most recent date practicable. Business of Stellar Biot echnologies, Inc., page 4 4. Please define the term Keyhole Limpet and KLH subunit the first time you use the terms. 5. Please expand the discussion to clarify whether you develop and manufacture the vaccines or whether you raise and harvest th e limpets from which a component of the vaccine is derived. Statement of Capitalization and Indebtedness, page 7 6. Please revise to include a statement of cap italization and indebte dness in dollar amounts or tell us how your statement complies with Item 3B of Form 20-F. Risk Factors – General 7. Please include a risk factor addressing competition in the production and marketing of KLH and the development of therapeutic va ccines, respectively, if material. If applicable, the discussion should also addre ss whether your KLH is unique relative to the KLH produced by other companies. 8. Please include a risk factor that addresses th e risks posed by the diminishing supply of M. crenulata in the wild due to the lack of regulation limiting th e fishery of limpets and the risk that the company’s aquaculture facil ity may not be sufficient to meet demand. “The Company faces uncertainties rela ted to regulatory approval.” page 9 9. Please discuss the specific regulatory approvals that the company must obtain to market and sell its current products and the status of such approvals. 10. Please clarify the extent to which you have c onducted the preclinical testing and clinical trials for products developed by others which products utilize your KLH. “Even if the Company obtains marketing approval…,” page 9 “The Company has limited marketing, sale s and distribution experience,” page 9 11. Please expand the discussion in these risk fact ors to clarify whether you are referring to your KLH product or the vaccines develope d by others which use your KLH as a component. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 3 “The Company is subject to the risk of product liability claims…,” page 10 12. Please expand the disclosure to state whethe r or not you currently maintain liability insurance, the amount of such coverage, and, if material, th e cost of such coverage. Similar risk factor disclosure should also be provided w ith respect to environmental and/or hazardous waste li ability, if material. “The Company has a history of net losses and limited cash flow…,’ page 10 13. Please expand the discussion to include the amount of net losses for ea ch of the last two years and your cumulative losses. “The Company will require additional financing…,” page 10 14. Please disclose whether your existing resource s will be sufficient to fund your operations for the next twelve months. If not, please disclose how long your existing resources will fund your operations. In additi on, please expand the discussion to quantify the amount of additional financing required for your budgeted expenditures, the nature of the expenditures, and when you will need the additional financing. “The Company has a dependence upon key management employees…,” page 11 15. Please expand the discussion to indicate th e extent to which you have employment contracts with your key employees. In addition, if applicable, please di scuss the extent to which you have previously experienced diffi culty in attracting a nd retaining qualified personnel. Corporate Background, page 13 16. Please expand the discussion to define th e terms “Capital Pool Corporation” and “qualifying transaction.” 17. Please describe the nature and extent of th e company’s activities prior to the reverse merger with Stellar CA. History and Development of the Business, page 13 18. Please discuss the conditions under which the 10 million performance shares were issuable and the extent to which any such shares have been issued. 19. We note the reference to the filing of pate nts in September 2010. Since Stellar CA was formed in 1999, please expand the discussion to cl arify the extent to which Stellar CA or its predecessors filed patents prior to September 2010 and when such patents were filed. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 4 20. We note the reference to the new facility wi th a spawning capacity of two million larvae, designed production of 50,000 juvenile limpets pe r year, and future production capacity of 20,000 grams of KLH annually. Please expand the discussion to explain the apparent discrepancy between spawning capacity and th e amount of designed production, i.e. do all but 50,000 of the larvae die before reaching juvenile stage or do you sell or intend to sell the larvae you do not use for your own production requirements. Capital Expenditures, page 15 21. Please expand the discussion to indicate your current KLH production capacity, the number of grams of KLH your actually produce currently, a nd the number of grams of KLH you sold in the last fiscal year. In addition, please expand the discussion of KLH where appropriate in the document to indicate the storage properties and “shelf life”, if any, for KLH. Business Overview, page 16 22. We note the statement that pharmaceutical fo rmulations of KLH typically sell for $5000 to $200,000 per gram. Please discuss the va riables for this range of pricing. 23. We note for the year ended August 31, 2011 you had revenues of approximately $79,000 from contract revenue and commercial sales. Assuming all of this revenue was derived from the sale of KLH, at the minimum price of $5000 per gram, it appears you sold approximately 16 grams of KLH. If so, pl ease explain the reason(s) for increasing your production capacity to 20,000 grams. We may have additional comments. Aquaculture, page 17 24. Please expand the discussion to indicate the approximate number of mature Giant Keyhole Lympets you currently have at your facility. In addition, please describe the approximate duration a mature Giant Keyhol e Lympet can be expected to produce hemolymph for your purposes. Company Products and Development, page 19 25. Please explain what you mean by the phrase “s upported by an FDA drug master file” and the significance of such information. 26. Please expand the discussion to describe whet her the immuno-toxicity diagnostic test you are developing requires regulatory approval and, if so, the nature of the requirements and your status in the approval process. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 5 Patents, page 21 27. Please include here a discussion of your September 9, 2010 patent filings for your inventions related to your native imm unogenic KLH technology pl atform and immune status monitoring product portfolio and cl arify the status of these filings. 28. Please expand the discussion to explain what you mean by the term “provisional patents.” 29. Please clarify whether the patent pertaining to non-lethal extraction me thods is the patent that was assigned to you from Mr. Oakes. 30. Please expand your disclosure to indicate the jurisdiction(s) for the granted and provisional patents. 31. Please provide the expiration date of the granted patent and with respect to the provisional patents, please e xpand the disclosure to describe what the patents or patent applications cover. New drug development, page 21 32. Please expand your disclosure to clarify whethe r the discussion pertains to the company’s activities related to new drugs and vaccines or to the activities of the companies to which Stellar sells its KLH. Results of Operations Year Ended August 31, 2011 vs. Year Ended August 31, 2010, page 23 33. Please expand the discussion to explain what you mean by the phrase “contract revenue of $60,000 from one customer for maintaining dedicated inventory.” 34. Please clarify whether the commercial sale s of $18,988 represents your entire sales of KLH for the year. If so, the sections enti tled “Business of Stella r Biotechnologies, Inc.” on page 4 and “History and Development of the Business” on page 13 should be expanded to quantify the limited amount of re venues you currently derive from your sales of KLH. 35. Please explain the reason why commercial sales dec lined from $299,700 in 2010 to $18,988 for the year ended 2011. Liquidity and Capital Resources, page 26 36. We note your statement that “management believes the current working capital, as well as anticipated revenue, is su fficient to meet the Company’ s contractual obligations and Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 6 anticipated research and development expendi tures in Fiscal 2011.” Please update this disclosure for the current fiscal year. Audit Committee, page 44 37. We note the statement that the audit committ ee charter has been filed as an exhibit, however the charter is not included in the list of exhibits and it doe s not appear that the charter has been filed. Please advise or revise. Item 8. Financial Information, page 48 38. Please include the more current interim fina ncial information published on February 28, 2012 in the filing. Please refer to Item 8A5 of Form 20-F and the related instructions. Current Legal Proceedings, page 49 39. Please expand the disclosure to indicate when the company filed its request to waive any penalties and when the revised discharge permit was issued. Shareholder Rights Plan, page 60 40. Please update the discussion to include the resu lts of the special meeting held on January 17, 2012. Exhibits, page 75 41. Please file the following documents or provi de us with your basis for not filing as exhibits the following documents pursuant to th e Instructions for exhibits to Form 20-F: The Bayer Innovation GmbH collaborative and license agreement(s) (page 14); Therapeutic Discovery Project Program grants (page 14); SAFC marketing and sale s agreement (page 14); National Science Foundati on grant (page 14); and The October 2011 agreement with Li fe Diagnostics, Inc. (page 14). Combined Statements of Cash Flows, page 81 42. Please revise your statement of cash flow to s how the effect of exchange rate changes on cash balances held in a foreign currency as a separate part of the reconciliation of the change in cash and cash equivalents. 43. Please tell us why the net assets assumed on recapitalization represent cash provided by financing activities when the cash acquired fr om the recapitalization of approximately $84 thousand is netted against other assets and liabilities acquired in the transaction. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 7 Please revise your statement of cash flow di sclosure to clarify that $84,012 in cash was acquired in the transaction. Notes to Consolidated Financial Statements Note 3. Merger Transaction, page 87 44. Your disclosure of the transaction appears to be inconsistent. Y ou disclose that the acquisition has been treated for accounting purposes as a recapit alization and then disclose in (b) that the tran saction has been accounted as a purchase of the assets and liabilities of the Company, which have been re corded at their fair values. Please revise your disclosure to state, if true, that CAG Capital, Inc. was non-operating and had only monetary assets and lia bilities at the date of the merger transaction, and there was no revaluation to fair value or tell us th e basis for your current disclosure. 45. You disclose in other sections of the f iling that 16,207,401 shares were issued in the merger agreement. This appears to be incons istent with your disclo sure that CAG issued 10,000,000 shares to Stellar CA shareholders completing the revers e takeover of the Company. Please revise your disclosure to eliminate all inconsistencies. Note 7. Licensing Rights, page 91 46. Please revise your disclosure to describe th e significant terms of your Bayer Innovation GmbH agreement including potential future mile stones. Also in the appropriate section of the notes describe the significant terms of other agreements, such as the agreements disclosed in Item 4. Note 10. Share Capital, page 92 47. Please revise your tabular disclosure informa tion for periods prior to the reverse merger, so that the equity of the legal parent is the historical equity of Stellar CA prior to the transaction, retroactively restated to reflect the number shares Stellar CA received in the transaction. In addition, refl ect the reverse merger as a line item during fiscal 2010 by showing the number of shares of the legal pa rent outstanding prior th e transaction. Revise your disclosure in Note 16 as appropriate. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Mr. Frank Oakes Stellar Biotechnologies, Inc. February 29, 2012 Page 8 In responding to our comments, please provi de a written statement from the company acknowledging that: In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Don Abbott, Senior Accountant, at (202) 551-3608, if you have que stions regarding