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Alpha Cognition Inc.
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Alpha Cognition Inc.
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Alpha Cognition Inc.
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Alpha Cognition Inc.
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Alpha Cognition Inc.
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Alpha Cognition Inc.
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Alpha Cognition Inc.
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2024-05-10
Alpha Cognition Inc.
Summary
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Company responded
2024-05-22
Alpha Cognition Inc.
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2024-06-06
Alpha Cognition Inc.
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Alpha Cognition Inc.
Awaiting Response
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2024-05-21
Alpha Cognition Inc.
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Alpha Cognition Inc.
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2024-04-17
Alpha Cognition Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-08-28 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-289792 | Read Filing View |
| 2025-07-23 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-23 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-288823 | Read Filing View |
| 2025-07-03 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-288454 | Read Filing View |
| 2025-07-03 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-01-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-01-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-284104 | Read Filing View |
| 2024-11-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-11-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-10-25 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-10-23 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07258 | Read Filing View |
| 2024-10-21 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-10-21 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-282675 | Read Filing View |
| 2024-06-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-05-22 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-05-21 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| 2024-05-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-289792 | Read Filing View |
| 2025-07-23 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-288823 | Read Filing View |
| 2025-07-03 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-288454 | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-284104 | Read Filing View |
| 2024-10-23 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07258 | Read Filing View |
| 2024-10-21 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 333-282675 | Read Filing View |
| 2024-05-21 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | Alpha Cognition Inc. | British Columbia, Canada | 377-07090 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-23 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-07-03 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-01-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2025-01-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-11-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-11-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-10-25 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-10-21 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-06-06 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-05-22 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
| 2024-05-10 | Company Response | Alpha Cognition Inc. | British Columbia, Canada | N/A | Read Filing View |
2025-08-28 - CORRESP - Alpha Cognition Inc.
CORRESP 1 filename1.htm Alpha Cognition Inc. 1452 Hughes Rd., Ste 200 Grapevine, Texas, 76051 August 28, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Alpha Cognition Inc. Registration Statement on Form S-3 File No. 333-289792 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:30 PM Eastern Time on August 29, 2025 or as soon thereafter as is practicable. Very truly yours, Alpha Cognition Inc. By: /s/ Michael McFadden Name: Michael McFadden Title: Chief Executive Officer cc: Dorsey & Whitney LLP
2025-08-28 - UPLOAD - Alpha Cognition Inc. File: 333-289792
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 28, 2025 Michael McFadden Chief Executive Officer Alpha Cognition Inc. 1452 Hughes Rd., Ste 200 Grapevine, Texas, 76051 Re: Alpha Cognition Inc. Registration Statement on Form S-3 Filed August 22, 2025 File No. 333-289792 Dear Michael McFadden: 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 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jason K. Brenkert, Esq. </TEXT> </DOCUMENT>
2025-07-23 - CORRESP - Alpha Cognition Inc.
CORRESP 1 filename1.htm ALPHA COGNITION INC. 1200 – 750 West Pender Street Vancouver, British Columbia V6C 2T8 July 23, 2025 Via EDGAR Division of Corporate Finance Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Mr. Lauren Hamill Re: Alpha Cognition Inc. – Request for Acceleration Registration Statement on Form S-3 File No. 333-288823 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the "Company"), hereby requests that the effective date for the Form S-3 registration statement (No. 333-288823), referred to above, be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on July 25, 2025, or as soon as possible thereafter. The Company hereby authorizes Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please contact Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective. Very truly yours, Alpha Cognition Inc. /s/ Michael McFadden Michael McFadden Chief Executive Officer
2025-07-23 - UPLOAD - Alpha Cognition Inc. File: 333-288823
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 23, 2025 Michael McFadden Chief Executive Officer Alpha Cognition Inc. 1452 Hughes Rd., Ste 200 Grapevine, TX 76051 Re: Alpha Cognition Inc. Registration Statement on Form S-3 Filed July 21, 2025 File No. 333-288823 Dear Michael McFadden: 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: Jason Brenkert </TEXT> </DOCUMENT>
2025-07-03 - UPLOAD - Alpha Cognition Inc. File: 333-288454
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 3, 2025 Michael McFadden Chief Executive Officer Alpha Cognition Inc. 1452 Hughes Rd., Ste 200 Grapevine, Texas, 76051 Re: Alpha Cognition Inc. Registration Statement on Form S-3 Filed July 1, 2025 File No. 333-288454 Dear Michael McFadden: 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 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jason K. Brenkert, Esq. </TEXT> </DOCUMENT>
2025-07-03 - CORRESP - Alpha Cognition Inc.
CORRESP 1 filename1.htm ALPHA COGNITION INC. 1200 – 750 West Pender Street Vancouver, British Columbia V6C 2T8 July 3, 2025 Via EDGAR Division of Corporate Finance Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Mr. Tim Buchmiller Re: Alpha Cognition Inc. – Request for Acceleration Registration Statement on Form S-3 File No. 333-288454 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the "Company"), hereby requests that the effective date for the Form S-3 registration statement (No. 333-288454), referred to above, be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on July 8, 2025, or as soon as possible thereafter. The Company hereby authorizes Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please contact Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective. Very truly yours, Alpha Cognition Inc. /s/ Michael McFadden Michael McFadden Chief Executive Officer
2025-01-10 - CORRESP - Alpha Cognition Inc.
CORRESP 1 filename1.htm ALPHA COGNITION INC. 1200 – 750 West Pender Street Vancouver, British Columbia V6C 2T8 January 10, 2025 Via EDGAR Division of Corporate Finance Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Mr. Alan Campbell Re: Alpha Cognition Inc. – Request for Acceleration Registration Statement on Form S-1/A File No. 333-284104 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the “Company”), hereby requests that the effective date for the Form S-1/A registration statement (No. 333-284104), referred to above, be accelerated so that it will be declared effective at 9:00 a.m. Eastern Time on January 13, 2025, or as soon as possible thereafter. The Company hereby authorizes Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please contact Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective. Very truly yours, Alpha Cognition Inc. /s/ Michael McFadden Michael McFadden Chief Executive Officer
2025-01-10 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
ALPHA COGNITION INC.
1200 – 750 West Pender Street
Vancouver, British Columbia V6C 2T8
January 10, 2025
Via EDGAR
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Mr. Alan Campbell
Re:
Alpha Cognition Inc. – Request for Acceleration
Registration Statement on Form S-1/A
File No. 333-284104
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the “Company”), hereby requests
that the effective date for the Form S-1/A registration statement (No. 333-284104), referred to above, be accelerated so that it will
be declared effective at 4:00 p.m. Eastern Time on January 13, 2025, or as soon as possible thereafter. The Company hereby authorizes
Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
Please contact Jason Brenkert
of Dorsey & Whitney LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective.
Very truly yours,
Alpha Cognition Inc.
/s/ Michael McFadden
Michael McFadden
Chief Executive Officer
2025-01-03 - UPLOAD - Alpha Cognition Inc. File: 333-284104
January 3, 2025
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 - 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Registration Statement on Form S-1
Filed December 31, 2024
File No. 333-284104
Dear Michael McFadden:
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:Jason K. Brenkert, Esq.
2024-11-06 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
November 6, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE: Alpha Cognition Inc. (“Company”)
Registration Statement on Form S-1
(File No. 333-280196) (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the
General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the “Securities Act”), Titan Partners
Group LLC, a division of American Capital Partners, LLC, as representative of the underwriters of the offering, hereby joins the request
of the Company that the effective date of the above-captioned Registration Statement be accelerated so as to permit it to become effective
on Friday, November 8, 2024, at 5:00 p.m., ET, or as soon thereafter as practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities and Exchange Commission under the Securities Act, we, acting on behalf of the several
underwriters, wish to advise you that, through November 6, 2024, we distributed to each underwriter or dealer, who is reasonably anticipated
to be invited to participate in the distribution of the security, as many copies, as well as “E-red” copies of the Preliminary
Prospectus dated November 6, 2024, as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We have
complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
TITAN PARTNERS GROUP LLC
A Division of American Capital Partners, LLC
By:
/s/ Adam Sands
Name: Adam Sands
Title: Authorized Representative
TitanPartnersGrp.com | Titan Partners Group LLC | 4 World Trade
Center, 29th Floor, New York, NY 10007
A division of and securities offered
through American Capital Partners, LLC, Member FINRA, SIPC, MSRB
2024-11-06 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
ALPHA COGNITION INC.
1200 – 750 West Pender Street
Vancouver, British Columbia V6C 2T8
November 6, 2024
Via EDGAR
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Ms. Tamika Sheppard
Re: Alpha
Cognition Inc. – Request for Acceleration
Registration Statement on Form S-1/A
File No. 333-280196
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the “Company”), hereby requests
that the effective date for the Form S-1/A registration statement (No. 333-282675), referred to above, be accelerated so that it will
be declared effective at 5:00 p.m. Eastern Time on Friday, November 8, 2024, or as soon as possible thereafter. The Company hereby authorizes
Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
Please contact Jason Brenkert of Dorsey & Whitney
LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective.
Very truly yours,
Alpha Cognition Inc.
/s/ Michael McFadden
Michael McFadden
Chief Executive Officer
2024-10-25 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
October 25, 2024
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
Attn:
Lauren Hamill
Re:
Alpha Cognition Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 16, 2024
File No. 333-280196
Ladies and Gentlemen,
Alpha Cognition Inc., a British Columbia corporation
(the “Company”), hereby provides the following information in response to the comments received from the staff (the
“Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in its letter to the
Company dated October 23, 2024 (the “Comment Letter”). The Company’s responses are preceded by a reproduction
of the corresponding Staff comments as set forth in the Comment Letter.
In addition, if the Staff would like hard copies
of the Amendment No. 3 to the Registration Statement on Form S-1 (“Amendment No. 3”) as filed with the Commission on
the date hereof, marked against the Registration Statement on Form S-1 as filed with the Commission on October 16, 2024, please so advise
and we would be happy to provide such copies.
Amendment No. 2 to Registration Statement on
Form S-1
Prospectus Summary
Summary Risk Factors, page 12
Staff Comment No. 1
We note the changes you made to your summary risk
factor disclosure beginning on page 13. Based on your disclosures throughout, including with respect to recent developments, it is unclear
to us that changes in your circumstances since the prior S- 1 review completed on June 7, 2024, warrant such revisions. By way of example
only:
● We note that in September 2024, you closed a
$4.545 million bridge financing through the issuance of convertible notes and warrants, that such convertible notes are subject to mandatory
conversion into common shares in conjunction with the closing of a Qualified Offering such as the offering being registered, and that
each bridge financing investor will receive an additional 50% of warrants relative to the principal amount of notes purchased with identical
terms upon the closing of a Qualified Offering. You also state throughout the registration statement that you are contemplating raising
additional capital by pursuing both dilutive and non- dilutive strategic sources of capital to executive your commercial and operating
plans. In light of the foregoing, please tell us why you have deleted summary risk factor disclosure relating to the dilution purchasers
in this offering will experience or may experience if you conduct future financings, or otherwise restore such disclosure.
● We note your disclosure that you are currently
primarily focused on the commercialization and further development of FDA-approved ZUNVEYL oral tablets or Alzheimer’s disease, that over
the coming year, you plan to begin commercialization of this product, and that you intend to use part of the net proceeds you receive
from this offering for the commercialization and launch of ZUNVEYL. In light of the foregoing, please tell us why you have deleted summary
risk factor disclosure relating to your plans to establish a commercialization infrastructure and scale up external manufacturing and
distribution capabilities to commercialize ZUNVEYL oral tabulation formulation, or otherwise restore such disclosure.
● Similarly, in light of your commercialization
plans for ZUNVEYL oral tablets, please tell us why you have deleted summary risk factor disclosure related to potential product safety
and product liability risks related to the use of your therapies, or otherwise restore such disclosure.
Company Response: The Company acknowledges
the Staff’s comment and has revised the S-1 in Amendment No. 3 to restore the summary risk factor disclosure beginning on page 13
in accordance with our prior S-1 filings, including those items referenced by way of example in the Staff’s comment.
Should you have any further comments or questions
about Amendment No. 3 or this letter, please contact our legal counsel, Jason K. Brenkert of Dorsey & Whitney LLP at 303-352-1133
or brenkert.jason@dorsey.com. We thank you for your time and attention.
Very truly yours,
ALPHA COGNITION INC.
By:
/s/ Michael McFadden
Michael McFadden
Chief Executive Officer
2024-10-23 - UPLOAD - Alpha Cognition Inc. File: 377-07258
October 23, 2024
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 – 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 16, 2024
File No. 333-280196
Dear Michael McFadden:
We have conducted a limited review of your 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 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 any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Amendment No. 2 to Registration Statement on Form S-1
Prospectus Summary
Summary Risk Factors, page 12
We note the changes you made to your summary risk factor disclosure beginning on
page 13. Based on your disclosures throughout, including with respect to recent
developments, it is unclear to us that changes in your circumstances since the prior S-
1 review completed on June 7, 2024, warrant such revisions. By way of example only:
We note that in September 2024, you closed a $4.545 million bridge financing
through the issuance of convertible notes and warrants, that such convertible notes
are subject to mandatory conversion into common shares in conjunction with the
closing of a Qualified Offering such as the offering being registered, and that each
bridge financing investor will receive an additional 50% of warrants relative to
the principal amount of notes purchased with identical terms upon the closing of a •1.
October 23, 2024
Page 2
Qualified Offering. You also state throughout the registration statement that you
are contemplating raising additional capital by pursuing both dilutive and non-
dilutive strategic sources of capital to executive your commercial and operating
plans. In light of the foregoing, please tell us why you have deleted summary risk
factor disclosure relating to the dilution purchasers in this offering will
experience or may experience if you conduct future financings, or otherwise
restore such disclosure.
•We note your disclosure that you are currently primarily focused on
the commercialization and further development of FDA-approved ZUNVEYL
oral tablets for Alzheimer's disease, that over the coming year, you plan to begin
commercialization of this product, and that you intend to use part of the net
proceeds you receive from this offering for the commercialization and launch of
ZUNVEYL. In light of the foregoing, please tell us why you have deleted
summary risk factor disclosure relating to your plans to establish a
commercialization infrastructure and scale up external manufacturing and
distribution capabilities to commercialize ZUNVEYL oral tabulation formulation,
or otherwise restore such disclosure.
•Similarly, in light of your commercialization plans for ZUNVEYL oral tablets,
please tell us why you have deleted summary risk factor disclosure related to
potential product safety and product liability risks related to the use of your
therapies, or otherwise restore such disclosure.
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.
Please contact Lauren Hamill at 303-844-1008 or Chris Edwards at 202-551-6761
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jason Brenkert
2024-10-21 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
ALPHA COGNITION INC.
1200 – 750 West Pender Street
Vancouver, British Columbia V6C 2T8
October 21, 2024
Via EDGAR
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Ms. Tamika Sheppard
Re: Alpha Cognition Inc. – Request for Acceleration
Registration Statement on Form S-1
Filed on October 16, 2024
File No. 333-282675
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the “Company”), hereby requests
that the effective date for the Form S-1 registration statement (No. 333-282675), referred to above, be accelerated so that it will be
declared effective at 4:00 p.m. Eastern Time on October 23, 2024, or as soon as possible thereafter. The Company hereby authorizes Jason
Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
Please contact Jason Brenkert of Dorsey & Whitney
LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective.
Very truly yours,
Alpha Cognition Inc
/s/ Michael McFadden
Michael McFadden
Chief Executive Officer
2024-10-21 - UPLOAD - Alpha Cognition Inc. File: 333-282675
October 21, 2024
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 – 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Registration Statement on Form S-1
Filed October 16, 2024
File No. 333-282675
Dear Michael McFadden:
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 Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jason Brenkert
2024-06-06 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
ALPHA COGNITION INC.
1200 – 750 West Pender Street
Vancouver, British Columbia V6C 2T8
June 6, 2024
Via EDGAR
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Ms. Lauren Hamill
Re: Alpha Cognition
Inc. – Request for Acceleration
Amendment No. 3 to Registration Statement
on Form S-1
Filed on June 4, 2024
File No. 333-278997
Ladies and Gentlemen:
Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Alpha Cognition Inc., a British Columbia corporation (the “Company”), hereby requests
that the effective date for the Form S-1 registration statement, as amended (No. 333-278997), referred to above, be accelerated so that
it will be declared effective at 4:00 p.m. Eastern Time on June 7, 2024, or as soon as possible thereafter. The Company hereby authorizes
Jason Brenkert of Dorsey & Whitney LLP, counsel to the Company, to orally modify or withdraw this request for acceleration.
Please contact Jason Brenkert of Dorsey & Whitney
LLP, counsel to the Company, at (303) 352-1133, as soon as the registration statement has been declared effective.
Very truly yours,
Alpha Cognition Inc.
/s/ Don Kalkofen
Don Kalkofen
Chief Financial Officer
2024-05-22 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
May 22, 2024
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
Attn:
Lauren Hamill
Re:
Alpha Cognition Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed May 10, 2024
File No. 333-278997
Ladies and Gentlemen,
Alpha Cognition Inc., a British
Columbia corporation (the “Company”), hereby provides the following information in response to the comments received
from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in
its letter to the Company dated May 21, 2024 (the “Comment Letter”). The Company’s responses are preceded by
a reproduction of the corresponding Staff comments as set forth in the Comment Letter.
In addition, if the Staff
would like hard copies of the Amendment No. 2 to the Registration Statement on Form S-1 (“Amendment No. 2”) as filed
with the Commission on the date hereof, marked against the Amendment No. 1 to the Registration Statement on Form S-1 as filed with the
Commission on May 10, 2024, please so advise and we would be happy to provide such copies. All page number references contained in the
Company’s responses below correspond to the page numbers in Amendment No. 2.
Amendment No. 1 to Registration Statement on
Form S-1
Prospectus Summary
Our Products and Approaches to Treatment, page
3
1. Please revise your pipeline table to ensure that all text, including footnotes, subscript, or other notations,
are clearly legible without the need for magnification.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 3 of Amendment No. 2 to make the text, footnotes, subscript and
other notations clearly legible.
2. We note your response to prior comment 5, and have the following additional comment. If true, please expand
your footnotes to the pipeline table to clarify that further development of ALPHA-1062IN is dependent upon (1) the out-license of ALPHA-1062IN
for mTBI and TBI to Alpha Seven Therapeutics Inc., which out-license has not yet occurred, and (2) Alpha Seven’s ability to raise sufficient
capital resources through financing(s).
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 3 of Amendment No. 2 to clarify in the footnotes to the pipeline
table that development of ALPHA-106IN is dependent on completion of the out-licensing with Alpha Seven Therapeutics and Alpha Seven raising
sufficient capital resources through financing.
3. We note your response to prior comment 6, which we reissue with respect to your discussion of the ALPHA-1062
sublingual formulation on page 5. Please specify the material resources that you must obtain in order to advance development of this program,
and describe any plans to procure such resources, to the extent such plans have been developed.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 5 of Amendment No. 2 to clarify that the sublingual formulation
is dependent upon receipt of additional capital resources through financing and that currently there are no specific plans for development.
Business
Our solution: Alpha-1062, page 85
4. We reissue the second and third bullets of prior comment 9 with respect to the following statement on
page 85: “According to third-party market research conducted by Infinity Group in October 2021, market research confirms that based
on the product attributes listed above, 88% of LTC prescribers are likely to prescribe ALPHA-1062, with a 29% preference share.”
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 85 of Amendment No. 2 to address the comment.
Exhibit Index, page II-8
5. In the next filing of your amended registration statement on Form S-1, please have your auditors correctly
state the Form to which their consent relates to.
Company Response: The Company
acknowledges the Staff’s comment and the auditor has revised their new consent to Amendment No. 2 to address the comment.
Should you have any further comments or questions
about Amendment No. 2 or this letter, please contact our legal counsel, Jason K. Brenkert of Dorsey & Whitney LLP at 303-352-1133
or brenkert.jason@dorsey.com. We thank you for your time and attention.
Very truly yours,
ALPHA COGNITION INC.
By:
/s/ Michael McFadden
Michael McFadden
Chief Executive Officer
2024-05-21 - UPLOAD - Alpha Cognition Inc. File: 377-07090
United States securities and exchange commission logo
May 21, 2024
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 - 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed May 10, 2024
File No. 333-278997
Dear Michael McFadden:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our May 8, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary
Our Products and Approaches to Treatment, page 3
1.Please revise your pipeline table to ensure that all text, including footnotes, subscript, or
other notations, are clearly legible without the need for magnification.
2.We note your response to prior comment 5, and have the following additional comment. If
true, please expand your footnotes to the pipeline table to clarify that further development
of ALPHA-1062IN is dependent upon (1) the out-license of ALPHA-1062IN for mTBI
and TBI to Alpha Seven Therapeutics Inc., which out-license has not yet occurred, and (2)
Alpha Seven's ability to raise sufficient capital resources through financing(s).
3.We note your response to prior comment 6, which we reissue with respect to your
discussion of the ALPHA-1062 sublingual formulation on page 5. Please specify the
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 21, 2024 Page 2
FirstName LastName
Michael McFadden
Alpha Cognition Inc.
May 21, 2024
Page 2
material resources that you must obtain in order to advance development of this program,
and describe any plans to procure such resources, to the extent such plans have been
developed.
Business
Our solution: Alpha-1062, page 85
4.We reissue the second and third bullets of prior comment 9 with respect to the
following statement on page 85: "According to third-party market research conducted by
Infinity Group in October 2021, market research confirms that based on the product
attributes listed above, 88% of LTC prescribers are likely to prescribe ALPHA-1062, with
a 29% preference share."
Exhibit Index, page II-8
5.In the next filing of your amended registration statement on Form S-1, please have your
auditors correctly state the Form to which their consent relates to.
Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Hamill at 303-844-1008 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jason Brenkert
2024-05-10 - CORRESP - Alpha Cognition Inc.
CORRESP
1
filename1.htm
May 10, 2024
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
Attn:
Lauren Hamill
Re:
Alpha Cognition Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted April 23, 2024
CIK No. 0001655923
Registration Statement on Form S-1 filed April 30, 2024
File No. 333-278997
Ladies and Gentlemen,
Alpha Cognition Inc., a British
Columbia corporation (the “Company”), hereby provides the following information in response to the comments received
from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in
its letter to the Company dated May 8, 2024 (the “Comment Letter”). The Company’s responses are preceded by a
reproduction of the corresponding Staff comments as set forth in the Comment Letter.
In addition, if the Staff
would like hard copies of the Amendment No. 1 to the Registration Statement on Form S-1 (“Amendment No. 1”) as filed
with the Commission on the date hereof, marked against the Registration Statement on Form S-1 as filed with the Commission on April 30,
2024, please so advise and we would be happy to provide such copies. All page number references contained in the Company’s responses
below correspond to the page numbers in Amendment No. 1.
Amendment No. 2 to Draft Registration
Statement on Form S-1 Our Business, page 1
1. We note your response to prior comment 1, which we reissue.
● Please revise your narrative disclosure here and elsewhere as appropriate to expressly
state, if true, that the following programs are in the preclinical development phase: (1) the sublingual formulation of ALPHA-1062 for
the treatment of mild-to-moderate AD and (2) ALPHA-1062IN for mTBI. For example only, revise your statements that a certain product candidate
is “in the early development stages” (page 5) or “is in development” (pages 1, 76 and 101) to provide greater specificity.
● Remove or revise the following statement on page 1 to reflect the current status
of any out-licensing plan: “ALPHA-1062...has been out-licensed to study an intranasal formulation for cognitive impairment with mTBI,”
or otherwise advise. In this regard, it appears from your other disclosures that the out-license of ALPHA-1062IN technology has not yet
occurred.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 1 of Amendment No. 1 and elsewhere throughout Amendment No. 1 to
clarify that the programs are in the preclincal development stage and to note that the outlicensing of ALPHA-1062IN has not yet occured.
2. Refer to the first sentence of the third paragraph in this section. If accurate,
please revise to clarify that ALPHA-0602, ALPHA-0702 and ALPHA-0802 are not the Company’s only preclinical stage assets. In this regard,
we note that the development of certain formulations of ALPHA-1062 are also currently in the preclinical development phase.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 1 of Amendment No. 1 to clarify that the outside of ALPHA-1062
oral formulation for Mild-to-Moderate Alzheimer’s Disease, the Company’s other products in its pipeline are in the preclinical
stage.
3. We note your response to prior comment 2, which we reissue. Notwithstanding the
Company’s plans to seek to out-license ALPHA-0602, please revise here and throughout where appropriate to briefly describe the eligibility
criteria and significance of having obtained Orphan Drug Designation for ALPHA-0602 for the treatment of ALS from the FDA.
Company
Response: The Company acknowledges the Staff’s comment and has revised the S-1
on pages 1 and 92 of Amendment No. 1 to describe the eligibility criteria and significance
of having obtained Orphan Drug Designation for ALPHA-0602 for the treatment of ALS from the
FDA.
4. Please revise your disclosure to describe briefly what you mean by “pivotal”
clinical trials the first time you use the term.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 4 and elsewhere throughout Amendment No. 1 to describe the Company’s
meaning of “pivotal” clinical trials.
Our Products and Approaches to Treatment,
page 3
5. With respect to your revised pipeline table on page 3:
● We reissue prior comment 6 with respect to the final bullet. If the pursuit of any
of indication may be delayed or is contingent upon obtaining additional resources (e.g., the out-licensing of ALPHA-1062IN for mTBI to,
and funding of, Alpha Seven, or marketing ALPHA-1062 as a treatment for mild-to- moderate AD), please clearly disclose this in a footnote
to the table.
● Revise to provide context for the reference to Alpha Seven in the column captioned
“Entity Responsible” in a footnote to the table.
● It appears the previous heading which clarified that the top three rows reflect
the development status of ALPHA-1062 programs has been deleted from the table. Please restore such heading.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 3 of Amendment No. 1 to (i) add a footnote to clarify that additional
capital resources through funding are needed to pursue that stated indication, (ii) clarify the context of Alpha Seven, and (iii) add
in the unintentionally omitted headings.
6. We note your response to prior comment 7. In the narrative discussion following
the pipeline table, you now state in various places that further development of various product candidates will be “contingent upon
additional resources” that the Company or Alpha Seven Therapeutics do not currently have, respectively. Please revise further to
specify the material resources that must be obtained by either company in order to advance development, and describe any plans to procure
such resources, to the extent such plans have been developed.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on pages 3-5 of Amendment No. 1 to clarify that the additional resources
needed are additional available capital through financings.
7. We note your response to prior comment 8. Please further revise page 4 to remove
any implications that your product candidates will be approved, will be approved quickly, or are more likely to receive FDA approval.
In this regard, please:
● clarify that use of the 505(b)(2) pathway does not guarantee an accelerated review
by the FDA
● clarify that FDA approval is not guaranteed notwithstanding the Company’s attempts
to conduct its pivotal studies “in direct alignment with the FDA feedback, as well as the FDA guidance document for 505(b)(2) approvals.”
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 4 of Amendment No. 1 and elsewhere throughout Amendment No. 1
to (i) clarify that use of the 505(b)(2) pathway does not guarantee an accelerated review by the FDA, and (ii) clarify that FDA approval
is not guaranteed.
2
8. We note your response to prior comment 9, which we reissue. Please specifically
revise the Summary in an appropriate place to disclose the geographic locations of completed clinical trials to date as you have on page
29. Alternatively, you may revise the summary risk factor on page 11 to clarify, if true, that all completed clinical trials of your product
candidates to date have been conducted outside the United States.
Company Response:
The Company acknowledges the Staff’s comment and has revised the S-1 on pages [●] of Amendment No. 1 to amend the summary
risk factor to clarify that all completed clinical trials to date have been conducted outside the United States.
Traumatic Brain Injury (TBI) Market,
page 3
9. We refer to your disclosure that you commissioned a market research report by Decision
Resources Group/Clarivate.
● Please revise to clarify the date of this market research report.
● With respect to the statements in your prospectus that are based on this report,
please revise to clarify whether such statements are statements of the third party or statements of the Company.
● If your disclosure attributes a statement to the third party, or if you commissioned
any other market or industry data cited in the prospectus including but not limited to research conducted by Infinity Group, please revise
your filing to identify such third party and file a consent from such third party. Please see Securities Act Rule 436 and Question 233.02
of the Securities Act Rules Compliance and Disclosure Interpretations.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 12 of Amendment No. 1 to (i) clarify that date of the third-party
market research report and (ii) clarify that statements based, in part, on the report are statements of the Company.
Traumatic Brain Injury: ALPHA-1062
Intranasal Formulation, page 5
10. We note your response to prior comment 11, which we reissue. The basis for the Company’s
expectation that Alpha Seven will complete the additional pre-clinical toxicity and manufacturing work for ALPHA-1062IN by the end of
2024 remains unclear, particularly in light of your disclosure that “further development work for ALPHA- 1062IN will require additional
resources which Alpha Seven Therapeutics does not currently have.”
Company Response:
The Company acknowledges the Staff’s comment and has revised the S-1 on pages [●] of Amendment No. 1 to clarify that completion
of the additional pre-clinical toxicity and manufacturing work is expected to be completed within 8 months of funding of Alpha Seven.
Recent Developments, page 9
11. We note your response to prior comment 14, which we reissue. In this regard, we
note that the reference to the Issuer’s Form 2A Listing Statement still appears at the bottom of page 9.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 5 of Amendment No. 1 to remove the noted reference.
Research and development of pharmaceuticals
is lengthy and inherently risky., page 31
12. Please revise the first sentence of this risk factor to clarify, if true, that other
than the oral tablet formulation of ALPHA-1062 for AD, all of your other programs, including those related to other formulations of ALPHA-1062,
are in pre-clinical development.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 31 of Amendment No. 1 to clarify that the outside of ALPHA-1062
oral formulation for Mild-to-Moderate Alzheimer’s Disease, the Company’s other products in its pipeline are in the preclinical
stage.
3
The regulatory approval processes
of the FDA and other comparable foreign regulatory authorities are lengthy..., page 51
13. We note your response to prior comment 18, which we reissue with respect to the
first bullet. Your statement on page 52 that you have not submitted for regulatory approval for any product candidate is inconsistent
with your disclosure elsewhere throughout that you have filed an NDA for ALPHA-1062 in AD. Please revise or advise.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 52 of Amendment No. 1 to note that we have submitted ALPHA-1062
in AD for approval.
14. The basis for your statement that you “have managed the regulatory approval
process with the FDA or any other regulatory authority only a limited number of times” is unclear. In this regard, we note your disclosure
on page 18 that to date, you have not yet demonstrated your ability to obtain regulatory approvals, among other things. Please revise
or advise.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 52 of Amendment No. 1 to clarify that while we have been engaged
in managing the approval process on a limited basis, we have not received regulatory approval for any of our products.
Our officers also serving as officers
of Alpha Seven may give rise to a conflict of interest..., page 59
15. Your disclosure that the Company owns approximately 47.5% of the issued and outstanding
shares of common stock of Alpha Seven is inconsistent with disclosure on page 1 that the Company retains 85.4% ownership of Alpha Seven.
Please reconcile or otherwise advise.’
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 59 of Amendment No. 1 to correct the typographical error and reconcile
these statements to reflect ownership of 85.4% of Alpha Seven.
ALPHA-1062 Clinical Development,
page 80
16. We note your response to prior comment 19, which we reissue with respect to the
first bullet. You state on page 80 that the Company completed two studies of ALPHA-1062 in Q2 2022 and a third in Q3 2022. However, it
appears that you have only disclosed the results of one study completed in Q2 2022. Please revise or advise.
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on page 80 of Amendment No. 1 to clarify that the displayed results are
for each of the three completed studies. As noted in the lead in to the table and in the sub-headings, the tables do show the results
of each of the two Q2 2022 studies and for the Q3 2022 study.
17. We note your response to prior comment 22, which we reissue in part. With respect
to each completed clinical trial discussed in this section, please revise to disclose the trial date(s) and trial location(s).
Company Response: The Company
acknowledges the Staff’s comment. The Company notes that the trial completion dates are set forth in this section just prior to
the table setting forth the results of the studies. Also, the Company previously added disclosure in this section noting that each of
the trials was completed in India. In response to the staff’s comment, the Company has revised the S-1 on page 80 of Amendment No.
1 to provide additional clarity on the trial dates and locations.
18. We note your response to prior comment 23, which we reissue in full. In this regard,
we reiterate that determinations as to safety, efficacy, and/or the sufficiency of any data the Company submitted to the FDA are solely
within the authority of the FDA. As such, please revise the following disclosure that implies or states a conclusion as to these matters:
● Revise the references to “positive pivotal study results” on page 80,
and to “positive results” and “positive pivotal data” on page 81.
● Remove the columns from the tables on page 80 captioned “Sufficient Date for
NDA Filing.”
● Below the tables on page 80, revise bulleted statements that “data confirmed”
ALPHA-1062 was bioequivalent to galantamine hydrobromide, and provide “necessary data for NDA filing (scientific bridge).”
4
● Similarly, remove or revise statements that data “confirmed” or “established”
bioequivalence of ALPHA-1062 and galantamine hydrobromide (pages 80-81). In this regard, we note you may present objective clinical trial
data resulting from trials without stating your conclusions as to bioequivalence.
● Remove or revise statements that data from a BABE study “strength the NDA application
for ALPHA-1062...” (page 81) and “strengthen the NDA data set...” (page 82).
Company Response: The Company
acknowledges the Staff’s comment and has revised the S-1 on pages 80-82 of Amendment No. 1 to (i) remove references to study results
being “positive”, (ii) rename the heading for the column in the table from “Sufficient Data for NDA Filing” to
“Data Enabled Filing of NDA” and (iii) revise language noted in the comment.
BABE Study vs. Extended Release,
page 81
19. We note your response to prior comment 24.
● We reissue the first bullet of
2024-05-08 - UPLOAD - Alpha Cognition Inc. File: 377-07090
United States securities and exchange commission logo
May 8, 2024
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 - 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted April 23, 2024
CIK No. 0001655923
Registration Statement on Form S-1 filed April 30, 2024
File No. 333-278997
Dear Michael McFadden:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our April 17, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Our Business, page 1
1.We note your response to prior comment 1, which we reissue.
•Please revise your narrative disclosure here and elsewhere as appropriate to expressly
state, if true, that the following programs are in the preclinical development phase:
(1) the sublingual formulation of ALPHA-1062 for the treatment of mild-to-moderate
AD and (2) ALPHA-1062IN for mTBI. For example only, revise your statements that
a certain product candidate is "in the early development stages" (page 5) or "is in
development" (pages 1, 76 and 101) to provide greater specificity.
•Remove or revise the following statement on page 1 to reflect the current status of
any out-licensing plan: "ALPHA-1062...has been out-licensed to study an intranasal
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 2
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 2
formulation for cognitive impairment with mTBI," or otherwise advise. In this regard,
it appears from your other disclosures that the out-license of ALPHA-1062IN
technology has not yet occurred.
2.Refer to the first sentence of the third paragraph in this section. If accurate, please revise
to clarify that ALPHA-0602, ALPHA-0702 and ALPHA-0802 are not the Company's only
preclinical stage assets. In this regard, we note that the development of certain
formulations of ALPHA-1062 are also currently in the preclinical development phase.
3.We note your response to prior comment 2, which we reissue. Notwithstanding the
Company's plans to seek to out-license ALPHA-0602, please revise here and throughout
where appropriate to briefly describe the eligibility criteria and significance of having
obtained Orphan Drug Designation for ALPHA-0602 for the treatment of ALS from the
FDA.
4.Please revise your disclosure to describe briefly what you mean by “pivotal” clinical trials
the first time you use the term.
Our Products and Approaches to Treatment, page 3
5.With respect to your revised pipeline table on page 3:
•We reissue prior comment 6 with respect to the final bullet. If the pursuit of any of
indication may be delayed or is contingent upon obtaining additional resources (e.g.,
the out-licensing of ALPHA-1062IN for mTBI to, and funding of, Alpha Seven, or
marketing ALPHA-1062 as a treatment for mild-to- moderate AD), please clearly
disclose this in a footnote to the table.
•Revise to provide context for the reference to Alpha Seven in the column captioned
"Entity Responsible" in a footnote to the table.
•It appears the previous heading which clarified that the top three rows reflect the
development status of ALPHA-1062 programs has been deleted from the table.
Please restore such heading.
6.We note your response to prior comment 7. In the narrative discussion following the
pipeline table, you now state in various places that further development of various product
candidates will be "contingent upon additional resources" that the Company or Alpha
Seven Therapeutics do not currently have, respectively. Please revise further to specify
the material resources that must be obtained by either company in order to advance
development, and describe any plans to procure such resources, to the extent such plans
have been developed.
7.We note your response to prior comment 8. Please further revise page 4 to remove any
implications that your product candidates will be approved, will be approved quickly,
or are more likely to receive FDA approval. In this regard, please:
•clarify that use of the 505(b)(2) pathway does not guarantee an accelerated review by
the FDA.
•clarify that FDA approval is not guaranteed notwithstanding the Company's attempts
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 3
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 3
to conduct its pivotal studies "in direct alignment with the FDA feedback, as well as
the FDA guidance document for 505(b)(2) approvals."
8.We note your response to prior comment 9, which we reissue. Please specifically revise
the Summary in an appropriate place to disclose the geographic locations of completed
clinical trials to date as you have on page 29. Alternatively, you may revise the summary
risk factor on page 11 to clarify, if true, that all completed clinical trials of your product
candidates to date have been conducted outside the United States.
Traumatic Brain Injury (TBI) Market, page 3
9.We refer to your disclosure that you commissioned a market research report by Decision
Resources Group/Clarivate.
•Please revise to clarify the date of this market research report.
•With respect to the statements in your prospectus that are based on this report, please
revise to clarify whether such statements are statements of the third party or
statements of the Company.
•If your disclosure attributes a statement to the third party, or if you commissioned any
other market or industry data cited in the prospectus including but not limited to
research conducted by Infinity Group, please revise your filing to identify such third
party and file a consent from such third party. Please see Securities Act Rule 436 and
Question 233.02 of the Securities Act Rules Compliance and Disclosure
Interpretations.
Traumatic Brain Injury: ALPHA-1062 Intranasal Formulation, page 5
10.We note your response to prior comment 11, which we reissue. The basis for the
Company's expectation that Alpha Seven will complete the additional pre-clinical toxicity
and manufacturing work for ALPHA-1062IN by the end of 2024 remains unclear,
particularly in light of your disclosure that "further development work for ALPHA-
1062IN will require additional resources which Alpha Seven Therapeutics does not
currently have."
Recent Developments, page 9
11.We note your response to prior comment 14, which we reissue. In this regard, we note that
the reference to the Issuer’s Form 2A Listing Statement still appears at the bottom of page
9.
Research and development of pharmaceuticals is lengthy and inherently risky., page 31
12.Please revise the first sentence of this risk factor to clarify, if true, that other than the oral
tablet formulation of ALPHA-1062 for AD, all of your other programs, including those
related to other formulations of ALPHA-1062, are in pre-clinical development.
The regulatory approval processes of the FDA and other comparable foreign regulatory
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 4
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 4
authorities are lengthy..., page 51
13.We note your response to prior comment 18, which we reissue with respect to the first
bullet. Your statement on page 52 that you have not submitted for regulatory approval for
any product candidate is inconsistent with your disclosure elsewhere throughout that you
have filed an NDA for ALPHA-1062 in AD. Please revise or advise.
14.The basis for your statement that you "have managed the regulatory approval process with
the FDA or any other regulatory authority only a limited number of times" is unclear. In
this regard, we note your disclosure on page 18 that to date, you have not yet
demonstrated your ability to obtain regulatory approvals, among other things. Please
revise or advise.
Our officers also serving as officers of Alpha Seven may give rise to a conflict of interest..., page
59
15.Your disclosure that the Company owns approximately 47.5 of the issued and outstanding
shares of common stock of Alpha Seven is inconsistent with disclosure on page 1 that the
Company retains 85.4% ownership of Alpha Seven. Please reconcile or otherwise advise.
ALPHA-1062 Clinical Development, page 80
16.We note your response to prior comment 19, which we reissue with respect to the first
bullet. You state on page 80 that the Company completed two studies of ALPHA-1062 in
Q2 2022 and a third in Q3 2022. However, it appears that you have only disclosed the
results of one study completed in Q2 2022. Please revise or advise.
17.We note your response to prior comment 22, which we reissue in part. With respect to
each completed clinical trial discussed in this section, please revise to disclose the trial
date(s) and trial location(s).
18.We note your response to prior comment 23, which we reissue in full. In this regard, we
reiterate that determinations as to safety, efficacy, and/or the sufficiency of any data the
Company submitted to the FDA are solely within the authority of the FDA. As such,
please revise the following disclosure that implies or states a conclusion as to these
matters:
•Revise the references to "positive pivotal study results" on page 80, and to "positive
results" and "positive pivotal data" on page 81.
•Remove the columns from the tables on page 80 captioned "Sufficient Date for NDA
Filing."
•Below the tables on page 80, revise bulleted statements that "data confirmed"
ALPHA-1062 was bioequivalent to galantamine hydrobromide, and
provide “necessary data for NDA filing (scientific bridge)."
•Similarly, remove or revise statements that data "confirmed" or "established"
bioequivalence of ALPHA-1062 and galantamine hydrobromide (pages 80-81). In
this regard, we note you may present objective clinical trial data resulting from trials
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 5
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 5
without stating your conclusions as to bioequivalence.
•Remove or revise statements that data from a BABE study "strength the NDA
application for ALPHA-1062..." (page 81) and "strengthen the NDA data set..." (page
82).
BABE Study vs. Extended Release, page 81
19.We note your response to prior comment 24.
•We reissue the first bullet of the prior comment in part. Please revise to disclose the
feedback the Company received regarding the ALPHA-1062 RESOLVE trial.
•We also reissue the second bullet of the prior comment in part. Please further revise
page 82 to highlight that although a PDUFA date has been provided, there is no
guarantee that the Company will not have to complete additional trials or studies in
order to seek regulatory approval for ALPHA-1062, and that ultimately such
approval may never be obtained.
20.You state that following the Q2 2022 meeting with FDA regarding the ALPHA-1062
program for mild-to-moderate AD, the "Company has since demonstrated required
stability endpoints for twelve months of long-term stability data in the three to-be-
marketed strengths of ALPHA-1062."
•Please revise this conclusory statement to avoid any suggestion that your data has
demonstrated or is likely to demonstrate stability to the satisfaction of the FDA.
You may disclose the stability endpoints and present objective stability data without
concluding that your data has met FDA requirements.
•Additionally, revise to qualify the phrase "to-be-marketed," as ALPHA-1062 has not
yet been approved.
21.We note your response to prior comment 25. Please disclose the information contained in
your response letter in your prospectus. Specifically, please:
•Revise your disclosure beginning on page 80 in an appropriate place to disclose that
the completed BABE studies were conducted on study participants from the general
population rather than an Alzheimer's population.
•Disclose the reason(s) why the Company determined the RESOLVE trial, which you
state was designed in part to measure adverse events in an Alzheimer’s population,
would not be implemented. Disclose whether, and if so how, the decision to forego
completing the RESOLVE trial may impact the NDA filed with the FDA.
•Make conforming revisions to the risk factor disclosure on page 18 as appropriate.
ALPHA-1062 Patent Portfolio, page 86
22.Although your response letter advises that page 86 was revised to address prior comment
30, we are unable to locate responsive revisions. We resissue prior comment 30 in full.
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 6
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 6
ALPHA-1062 Regulatory Matters, page 90
23.We note your revisions in response to prior comment 33. You have added a cross-
reference to disclosure on page 33 as it relates to potential partnership agreements in non-
US territories. We are unable to locate the disclosure to which you refer on page
33. Please revise or advise.
Financing Activities, page 107
24.We note your response to prior comment 36, which we reissue with respect to the first
bullet. Please define acronym "NLS" at first use in the prospectus.
Alpha 1062 Technology, page 109
25.We note your response to prior comment 37. You state on page 110 that the Memogain
Technology License Agreement will terminate upon the later of twenty years from the
Commencement Date (March 15, 2035) or the expiration of the last patent
obtained. Please revise to clarify when this patent is expected to expire.
Experts, page 163
26.Please update this section to reflect the financial statements that are included in the
registration statement.
Financial Statements
Note 2: Significant Accounting Policies
Grant Accounting, page F-12
27.Please explain to us why $69,416 from the federal wage tax credits refund relating to
subcontractor costs is included in grant income. If this amount is not specifically related to
the grant, please revise to remove this amount from grant income. If this expense is related
to the grant, specifically disclose this fact or explain why the amount is appropriately
classified as grant income.
Form S-1 filed April 30, 2024
Exhibit Index, page II-8
28.Please have your auditors revise their auditor consent filed as Exhibit 23.1 to correctly
state the audit report date.
General
29.Please revise your exhibit index to include the filing fee table. Refer to Item 601 of
Regulation S-K.
30.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,
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
May 8, 2024 Page 7
FirstName LastName
Michael McFadden
Alpha Cognition Inc.
May 8, 2024
Page 7
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Hamill at 303-844-1008 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jason Brenkert
2024-04-17 - UPLOAD - Alpha Cognition Inc. File: 377-07090
United States securities and exchange commission logo
April 17, 2024
Michael McFadden
Chief Executive Officer
Alpha Cognition Inc.
1200 - 750 West Pender Street
Vancouver, BC, V6C 2T8
Re:Alpha Cognition Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted March 21, 2024
CIK No. 0001655923
Dear Michael McFadden:
We have reviewed your draft registration statement and have the following comments.
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 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 amended
draft registration statement or filed registration statement, we may have additional comments.
Amendment No.1 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Business, page 1
1.Please revise the last sentence of the second paragraph of this section, pages 4-5, and
elsewhere throughout as appropriate, to clarify that the following programs are only in the
preclinical development phase: (1) the sublingual formulation of ALPHA-1062 for the
treatment of mild-to-moderate AD, (2) ALPHA-1062 in combination with memantine for
the treatment of moderate-to-severe AD, and (3) ALPHA-1062IN for mTBI. Also, revise
statements such as the following on pages 1 and 28 to reflect the current status of any out-
licensing plan: "ALPHA-1062...has been out-licensed to study an intranasal formulation
for cognitive impairment with mTBI."
2.Please revise to briefly describe the significance of having obtained Orphan Drug
Designation for ALPHA-0602 for the treatment of ALS.
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
April 17, 2024 Page 2
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
April 17, 2024
Page 2
3.Throughout the registration statement, we note numerous unqualified and/or conclusory
statements regarding your business and your future development and commercialization
plans, including statements that inappropriately assume the occurrence of certain material
events or outcomes, or imply that your product candidates will ultimately be successful.
Please review and revise statements throughout such as the following, which are listed by
way of example only and not limitation:
•"As a result of FDA feedback and following the out-licensing to Alpha Seven and its
needed capital raise, Alpha Seven will be in a position to complete additional
manufacturing and toxicity work which will allow Alpha Seven to initiate a Phase 2
clinical study." (page 1)
•"ALPHA-1062 sublingual formulation...is in early development phases and will be
advanced after commercialization of ALPHA-1062." (page 4)
•"Once the Company completes the clinical trials and receive approval for ALPHA-
1062 for mild-to-moderate Alzheimer’s Disease, we plan to continue progression in
clinical trials with ALPHA-1062 + memantine. The Company plans to initiate the
streamlined 505(b)2 regulatory path for approval." (pages 4 and similar on page 85)
•"During the second half of 2023 the Company started, in parallel with the Company’s
regulatory activities, taking steps to develop a commercialization team to ensure a
successful launch in the U.S." (page 81)
•"Success will be further enabled by securing product coverage with U.S. payors.
Market." (page 81)
•"As the Company progresses closer to commercialization, after the approval of
ALPHA-1062 for mild-to-moderate Alzheimer’s Disease, the payer team will glean
additional insights from their customer to ensure price and coverage acceptance by
the payer community." (page 85)
•"For caregivers, we will deploy a targeted multi-channel market campaign aimed at
creating awareness and motivating requests for ALPHA-1062 + memantine from
their physician."
•"The Company believes that ALPHA-0602 will have seven year marketing
exclusivity due to ALPHA-0602 Orphan Drug Designation in the U.S." (page 88)
•"[T]he Company is satisfied that the CROs and sites meet the international and FDA
standards required for successful conduct of the Pilot Pivotal Studies required for
NDA approval." (page 89)
TBI Out-License, page 1
4.With respect to this subsection in the Summary, please address the following:
•If true, revise the caption of this discussion to highlight that the out-license ALPHA-
1062IN has not yet occurred.
•While we acknowledge your disclosure on page 2 that the establishment and funding
of Alpha Seven is at the proposal stage only, please revise your discussion to qualify
conclusory "will" statements and other statements drafted in the present tense so as to
clarify that the Company's plans with respect to Alpha Seven Therapeutics Inc.
("Alpha Seven") are currently aspirational.
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
April 17, 2024 Page 3
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
April 17, 2024
Page 3
•Disclose when and where Alpha Seven was incorporated.
•Disclose the identity of the agent that has agreed to conduct a capital raise for Alpha
Seven in exchange for an initial 37.5% ownership interest in Alpha Seven.
•Clarify how much time that Mr. McFadden and Ms. D’Angelo will devote to your
business and how their participation with Alpha Seven could create a conflict of
interest.
Alzheimer's Disease Moderate-to-Severe Stage Market, page 2
5.Please provide the basis for the following statement, or otherwise revise: "Most providers
and caregivers believe the approved generic medications provide limited efficacy, and the
currently available branded combination medication doesn’t deliver any differentiating
features."
Our Products and Approaches to Treatment, page 3
6.The pipeline table at the top of page 3 should graphically demonstrate the current status of
your material product candidates, as well as indicate the material stages you will need to
complete before marketing your products. The table should be a reflection of the narrative
disclosure in the prospectus and should not be used to prematurely project successful
completion of the stages required prior to regulatory approval and commercialization or to
emphasize currently immaterial assets. A narrative discussion is more appropriate with
respect to aspirational plans for your product candidates, such as intended preclinical or
clincial studies, potential partnerships, or regulatory submissions. As such, we have the
following comments:
•Please remove the dashed line progress bar extending through the end of Phase 1 for
ALPHA-1062IN. In this regard, we note your disclosure on page 4 that you have
completed a pre-clinical study of ALPHA-1062IN in mTBI, and have received FDA
feedback that "further toxicity and manufacturing work will be needed to file IND
and enter into a Phase 2 trial."
•If true, please tell us why you believe the ALPHA-1062 sublingual formulation is
currently sufficiently material to your operations to warrant inclusion in the pipeline
table. In this regard, we note that you state on page 4 that the sublingual formulation
"will be developed as an alternative formulation" to the oral tablet; however, your
narrative disclosure appears to include no substantive discussion of the status of any
preclinical studies involving the sublingual formulation or the Company's
development plans with respect thereto. Further, your Business discussion appears to
contain no mention of the sublingual formulation.
•Tell us why you believe it is appropriate to include each of ALPHA-0602, -0702 and
-0802 in the pipeline table. In this regard, we note your disclosure on page 5 that you
have "paused further development of ALPHA-0602 and the granulin program and
will seek to out-license the assets." Further, with respect to ALPHA-0602, -0702 and
-0802, you appear to have included no substantive Business discussion regarding the
development status of these assets. It is also unclear from your disclosure on page
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
April 17, 2024 Page 4
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
April 17, 2024
Page 4
109 whether the Company has license agreements covering the right to
develop ALPHA-0702 and -0802. Please also revise page 109 as appropriate to
clarify, or advise.
•We note your filing contains no substantive discussion regarding your pursuit of
spinal muscular atrophy (SMA) as an indication for the "Progranulin franchise." As
such, it is unclear that such pursuit is currently sufficiently material to your
operations to warrant reference thereto in the pipeline table. Please remove from the
table or advise.
•If the pursuit of any of indication may be delayed or is contingent upon obtaining
additional resources (e.g., the out-licensing of ALPHA-1062IN for mTBI to, and
funding of, Alpha Seven, or marketing ALPHA-1062 as a treatment for mild-to-
moderate AD), please clearly disclose this in a footnote or in the narrative discussion
surrounding the pipeline table.
7.In the narrative disclosure following the pipeline table and in Business, please revise your
discussion of each product candidate in preclinical development to describe the status of
your preclinical development efforts to date. To the extent you have yet to conduct
certain preclinical trials or IND-enabling studies required as a prerequisite to preparing an
IND for submission, please revise your disclosure to clarify. Describe all material steps
you will need to complete before the Company can file and IND with the FDA in order to
advance the candidate into clinical trials.
8.Under the heading “Alzheimer’s Disease Mild-to-Moderate Stage," please briefly explain
what the Section 505(b)(2) regulatory approval pathway entails. Also, explain what a
"bioavailability and bioequivalence pivotal study" is and how it differs from traditional
efficacy trials. Explain the Company's strategy to use such a pivotal study to seek
regulatory approval, and explain the basis for your belief, if any, that the FDA has agreed
or will agree that the pivotal studies may be sufficient for the approval of the
commercialization of the ALPHA-1062 oral table for treatment of Mild-to-Moderate
Alzheimer's Disease. Where appropriate throughout the Summary, disclose whether or
not you discussed your pivotal study results with the FDA prior to submitting the NDA,
and if so, describe the outcome of such discussions.
9.Please revise your Summary to disclose where your clinical trials have been conducted to
date. In this regard, we note your disclosure on page 28 that you initially conducted a
clinical trial of ALPHA-1062 in India, and conducted Phase 1 single and multiple
ascending dose studies of ALPHA-1062 in healthy volunteers in the Netherlands. Also
revise to highlight that clinical data generated outside the U.S. may not be accepted by the
FDA.
Traumatic Brain Injury (TBI) Market, page 3
10.You disclose that more than 5.3 million children and adults in the United States are living
with a permanent brain injury-related disability. Please revise to:
•Clarify whether ALPHA-1062IN is being developed for both adult and pediatric
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
April 17, 2024 Page 5
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
April 17, 2024
Page 5
subpopulations of TBI patients.
•Clarify whether the $17B U.S. market size pertaining to cognitive impairment
management includes both children and adults. To the extent you plan to develop
ALPHA-1062 for a specific subset of the TBI patient population, revise to clarify the
estimated patient population(s) and addressable market size you are targeting
accordingly.
•Revise your disclosure as appropriate to provide the sources upon which you are
basing your estimates, as well as any material assumptions and limitations associated
with your estimates. In this regard, we note the statement "see source in comments"
on page 3. It is unclear what disclosure this notation refers to.
Traumatic Brain Injury: ALPHA-1062 Intranasal Formulation, page 4
11.Please revise this section to explain the basis for the Company's expectation that Alpha
Seven "will initiate the additional toxicity and manufacturing work which is anticipated to
be completed by the end of 2024." In this regard, we note your disclosure elsewhere
that the planned out-licensing of ALPHA-1062IN to Alpha Seven has not yet occurred.
Further, we note that as of September 30, 2023, the Company has advanced Alpha Seven
$55,000 pursuant to a loan agreement, but the "needed capital raise" for Alpha Seven to
develop ALPHA-1062IN has also not yet occurred. Revise to disclose all material steps
you will need to complete before "Alpha Seven would then be in the position to file an
IND for ALPHA-1062IN."
Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig's disease: ALPHA-0602 (Progranulin and
Granulin Epithelin Modules), page 5
12.Here and in your Business discussion, please revise to clarify the reason(s) why the
Company has "paused further development of ALPHA-0602 and the granulin program
and will seek to out-license the assets." Also, please clarify here and elsewhere as
appropriate whether the development of ALPHA-0702 and -0802, which are Granulin
Epithelin Motifs, (“GEMs”), is similarly paused, and whether you will seek to out-license
these assets.
Our Strategy, page 5
13.Here, and elsewhere as appropriate, explain the meaning of being granted a PDUFA goal
date of July 27, 2024, and the potential outcomes that may result from the FDA's review
of ALPHA-1062 in mild-to-moderate Alzheimer's disease. Balance your disclosure by
stating, if true, that notwithstanding the goal date, the FDA could conduct a longer than
expected regulatory review process, resulting in increased expected development costs or
the delay or prevention of commercialization of ALPHA-1062. Also disclose that even if
ALPHA-1062 is ultimately approved, it may not achieve commercial success. Explain, if
true, that you do not expect ALPHA-1062 to be commercially available immediately
following approval. Disclose, as you do elsewhere throughout, that the Company will
need to raise substantial additional capital in order to fund its operations and
FirstName LastNameMichael McFadden
Comapany NameAlpha Cognition Inc.
April 17, 2024 Page 6
FirstName LastNameMichael McFadden
Alpha Cognition Inc.
April 17, 2024
Page 6
commercialization plans for ALPHA-1062, if approved.
Recent Developments, page 8
14.Please revise page 8 to remove the reference to the Issuer's Form 2A Listing Statement,
which appears to be a form utilized by the Canadian Securities Exchange.
Summary Risk Factors
Risks Related to Our Common Shares and this Offering, page 10
15.This registration statement relates to the resale of common shares by the selling
stockholders listed starting on page 144. However, this section and the similar Risk
Factors section beginning on page 60 include references to, and risk factors attendant to, a
primary offering. Please review and revise these sections and elsewhere as appropriate to
ensure they contain disclosure applicable to a secondary offering only. By way of example
only, please refer to the following statements:
•"Even if this Offering is successful, we will need substantial additional capital..."
(page 10)
•"We have broad discretion to determine how to use the funds raised in this
offering..." (page 12)
•"Purchasers in this offering will experience immediate and substantial dilution in the
book value of their investment." (Page 13)
•Note also statements throughout referring to the "consummation" or "closing of this
offering."
We will need substantial additional capital to meet our financial obligations and to pursue our
business objectives., page 17
16.Please refer to the following