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Correspondence 0001213900-24-041784 from Alpha Cognition Inc. (ACOG)

Alpha Cognition Inc.
Date: May 10, 2024 · CIK: 0001655923 · Accession: 0001213900-24-041784

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File numbers found in text: 333-278997

Date
May 10, 2024
Author
Not clearly detected
Form
CORRESP
Company
Alpha Cognition Inc.

Letter

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.

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.

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).”

● 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

Show Raw Text
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