What changed in this filing

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Item 9A. Controls and Procedures

2024-03-28 compared with 2023-03-31 · 107 added, 115 removed, 150 unchanged (60% of the section changed)

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls

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Based on the evaluation of our disclosure controls

and procedures as of December 31, 2022, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date,

our disclosure controls and procedures were not effective as we did not design or maintain an effective control environment commensurate

with the financial reporting requirements.

Specifically, we lack a sufficient number of professionals with an appropriate level of accounting

knowledge, training and experience to appropriately analyze, record and disclose accounting matters timely and accurately while maintaining

appropriate segregation of duties.

Without such professionals, we did not design and maintain formal accounting policies, procedures

and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, including controls over the preparation

and review of account reconciliations and journal entries.

and procedures as of December 31, 2023, our Chief Executive Officer and our Chief Financial Officer determined, based upon the existence

of the material weakness described below, that we did not maintain effective internal control over financial reporting as of December

Specifically, we lack a sufficient number of professionals with an appropriate level of accounting knowledge, training and

experience to appropriately analyze, record and disclose accounting matters timely and accurately while maintaining appropriate segregation

Without such professionals, we did not design and maintain formal accounting policies, procedures and controls to achieve

complete, accurate and timely financial accounting, reporting and disclosures, including controls over the preparation and review of

account reconciliations and journal entries.

The lack of adequate staffing levels and expertise

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weakness in our internal control over financial reporting.

To address the issues, we plan to hire additional personnel.

Specifically,

management will:

● Increase the number of accounting

● Engage third party experts to assist

management in completing a comprehensive risk assessment to identify, design and implement

control activities;

● Review and enhance business policies,

procedures and related internal controls to standardize business processes.

We expect to complete the remediation by the

We expect to incur additional costs to remediate this weakness, primarily personnel costs.

To address the issues, management has:

the number of accounting personnel;

third party experts to assist management in analyses and conclusions involving complex or infrequently applied accounting treatment;

third party experts to assist management in completing a comprehensive risk assessment to identify, design and implement control activities.

In addition, management is taking steps to review

and enhance business policies, procedures and related internal controls to standardize business processes.

We expect to complete the remediation

by the end of 2024.

We expect to incur additional costs to remediate this weakness.

Management’s Report on Internal Control

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weakness in our internal control over financial reporting.

To address the issues, we plan to hire additional personnel.

Specifically,

management will:

● Increase the number of accounting

● Engage third party experts to assist

management in completing a comprehensive risk assessment to identify, design and implement

control activities;

● Review and enhance business policies,

procedures and related internal controls to standardize business processes.

To address the issues, management has:

the number of accounting personnel;

third party experts to assist management in analyses and conclusions involving complex or infrequently applied accounting treatment;

third party experts to assist management in completing a comprehensive risk assessment to identify, design and implement control activities.

In addition, management is taking steps to review

and enhance business policies, procedures and related internal controls to standardize business processes.

We expect to complete the remediation by the

We expect to incur additional costs to remediate this weakness, primarily personnel costs.

We expect to incur additional costs to remediate this weakness.

This Annual Report on Form 10-K does not include

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OTHER INFORMATION

DISCLOSURE REGARDING

FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS

THAT PREVENT INSPECTIONS.

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND

CORPORATE GOVERNANCE

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item is incorporated

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by reference from the information contained in the 2024 Proxy Statement under the heading “Executive Compensation.”

SECURITY OWNERSHIP

OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL

OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this item is incorporated

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Owners and Management and Related Stockholder Matters.”

CERTAIN RELATIONSHIPS

AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

CERTAIN RELATIONSHIPS AND RELATED

TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this item is incorporated

by reference from the information contained in the 2024 Proxy Statement under the headings “Family Relationships and other Arrangements.”

PRINCIPAL ACCOUNTANT

FEES AND SERVICES

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this item is incorporated

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EXHIBITS, FINANCIAL STATEMENT SCHEDULES

following documents are filed as part of this report:

(1) Financial

The following documents

are filed as part of this report:

Financial Statements:

The financial statements required by this

Item are included beginning at page F-1.

(2) Financial

Statement Schedules:

Financial Statement Schedules:

All financial statement schedules have been omitted

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The following documents are included as exhibits to this report.

and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.4 to Amendment No.

2 to Form S-1 filed on June

of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (incorporated by reference

to Exhibit 3.1 to Form 8-K filed on March 6, 2023)

and Restated Bylaws (incorporated by reference to Exhibit 3.5 to Amendment No.

Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.4 to Amendment No.

2 to Form S-1 filed on June 21, 2021)

Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on March 6, 2023)

Stock Certificate evidencing the shares of common stock (incorporated by reference to Exhibit 4.1 to Form S-1 filed on May

of Warrant Agent Agreement (including the terms of the Warrant) (incorporated by reference to Exhibit 4.2 to Amendment No.

S-1 filed on June 21, 2021)

of Underwriter’s Unit Purchase Option (incorporated by reference to Exhibit 4.3 to Amendment No.

2 to Form S-1 filed

on June 21, 2021)

of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference

to Exhibit 4.4 to Form 10-K filed on March 31, 2022).

of Specimen Stock Certificate for Series A-1 Preferred Stock (incorporated by reference to Exhibit 4.1 to Form 8-K filed on March

of Tranche A Warrant (incorporated by reference to Exhibit 4.2 to Form 8-K filed on March 6, 2023)

of Tranche B Warrant (incorporated by reference to Exhibit 4.3 to Form 8-K filed on March 6, 2023)

of Tranche C Warrant (incorporated by reference to Exhibit 4.4 to Form 8-K filed on March 6, 2023)

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.5 to Amendment No.

2 to Form S-1 filed on June 21, 2021)

Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (incorporated by reference to Exhibit 3.6 to Form 8-K filed on March 14, 2024)

Certificate of Elimination of Series A-1 Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on March 14, 2024)

Certificate of Elimination of Series A-2 Preferred Stock (incorporated by reference to Exhibit 3.2 to Form 8-K filed on March 14, 2024)

Certificate of Elimination of Series A-3 Preferred Stock (incorporated by reference to Exhibit 3.3 to Form 8-K filed on March 14, 2024)

Certificate of Elimination of Series A-4 Preferred Stock (incorporated by reference to Exhibit 3.4 to Form 8-K filed on March 14, 2024)

Certificate of Elimination of Series A-5 Preferred Stock (incorporated by reference to Exhibit 3.5 to Form 8-K filed on March 14, 2024)

Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Voting Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on March 14, 2024)

Specimen Stock Certificate evidencing the shares of common stock (incorporated by reference to Exhibit 4.1 to Form S-1 filed on May 21, 2021)

Form of Warrant Agent Agreement (including the terms of the Warrant) (incorporated by reference to Exhibit 4.2 to Amendment No.

2 to Form S-1 filed on June 21, 2021)

Form of Underwriter’s Unit Purchase Option (incorporated by reference to Exhibit 4.3 to Amendment No.

2 to Form S-1 filed on June 21, 2021)

Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.4 to Form 10-K filed on March 31, 2022).

Form of Specimen Stock Certificate for Series A-1 Preferred Stock (incorporated by reference to Exhibit 4.1 to Form 8-K filed on March 6, 2023)

Form of Tranche A Warrant (incorporated by reference to Exhibit 4.2 to Form 8-K filed on March 6, 2023)

Form of Tranche B Warrant (incorporated by reference to Exhibit 4.3 to Form 8-K filed on March 6, 2023)

Form of Tranche C Warrant (incorporated by reference to Exhibit 4.4 to Form 8-K filed on March 6, 2023)

Form of Amended and Restated Tranche A Warrant (incorporated by reference to Exhibit 4.1 to Form 8-K filed on March 14, 2024)

Form of Amended and Restated Tranche B Warrant (incorporated by reference to Exhibit 4.2 to Form 8-K filed on March 14, 2024)

Form of Amended and Restated Tranche C Warrant (incorporated by reference to Exhibit 4.3 to Form 8-K filed on March 14, 2024)

2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to Amendment No.

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2021 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Form S-1 filed on June 7, 2021)

and Asset Purchase Agreement by and between the Company and Spectrum Pharmaceuticals, Inc., dated September 20, 2018 (incorporated

by reference to Exhibit 10.4 to Amendment No.

Assignment and Asset Purchase Agreement by and between the Company and Spectrum Pharmaceuticals, Inc., dated September 20, 2018 (incorporated by reference to Exhibit 10.4 to Amendment No.

1 to Form S-1 filed on June 7, 2021)

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1 to Form S-1 filed on June 7, 2021)

Agreement by and between the Company and Globavir Biosciences, Inc.

dated July 1, 2017 (incorporated by reference to Exhibit 10.6

to Amendment No.

Service Agreement by and between the Company and Globavir Biosciences, Inc.

dated July 1, 2017 (incorporated by reference to Exhibit 10.6 to Amendment No.

1 to Form S-1 filed on June 7, 2021)

Agreement by and between the Company and Shalabh Gupta, M.D., dated May 18, 2021 (incorporated by reference to Exhibit 10.7 to Form

S-1 filed on May 21, 2021)

Agreement by and between the Company and Pramod Gupta, M.D., dated March 22, 2021 incorporated by reference to Exhibit 10.8 to Form

S-1 filed on May 21, 2021)

to Employment Agreement by and between the Company and Pramod Gupta, M.D., dated April 28, 2021 (incorporated by reference to Exhibit

10.9 to Form S-1 filed on May 21, 2021)

Services Agreement, dated February 8, 2021, by and between Unicycive Therapeutics, Inc.

Employment Agreement by and between the Company and Shalabh Gupta, M.D., dated May 18, 2021 (incorporated by reference to Exhibit 10.7 to Form S-1 filed on May 21, 2021)

Employment Agreement by and between the Company and Pramod Gupta, M.D., dated March 22, 2021 incorporated by reference to Exhibit 10.8 to Form S-1 filed on May 21, 2021)

Amendment to Employment Agreement by and between the Company and Pramod Gupta, M.D., dated April 28, 2021 (incorporated by reference to Exhibit 10.9 to Form S-1 filed on May 21, 2021)

Master Services Agreement, dated February 8, 2021, by and between Unicycive Therapeutics, Inc.

and Ascent Development Services, Inc.

(incorporated

by reference to Exhibit 10.10 to Form S-1 filed on May 21, 2021)

Agreement effective as of July 14, 2022 by and between Unicycive Therapeutics, Inc.

and Lee’s Pharmaceutical (HK) Limited (incorporated

by reference to Exhibit 10.1 to Form 8-K filed on July 18, 2022)

Agreement effective as of February 1, 2023 by and between Unicycive Therapeutics, Inc.

(incorporated by reference to Exhibit 10.10 to Form S-1 filed on May 21, 2021)

License Agreement effective as of July 14, 2022 by and between Unicycive Therapeutics, Inc.

and Lee’s Pharmaceutical (HK) Limited (incorporated by reference to Exhibit 10.1 to Form 8-K filed on July 18, 2022)

License Agreement effective as of February 1, 2023 by and between Unicycive Therapeutics, Inc.

and Lotus International Pte Ltd.

(incorporated

by reference to Exhibit 10.1 to Form 8-K filed on February 2, 2023)

of Securities Purchase Agreement, dated March 3, 2023, by and between Unicycive Therapeutics, Inc.

and the purchasers named therein

(incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 6, 2023)

Agency Agreement, dated March 3, 2023 by and between Unicycive Therapeutics, Inc.

and EF Hutton, division of Benchmark Investments,

LLC (incorporated by reference to Exhibit 10.2 to Form 8-K filed on March 6, 2023)

of Business Conduct and Ethics (incorporated by reference to Exhibit 14.1 to Form 10-K filed on March 31, 2022).

(incorporated by reference to Exhibit 10.1 to Form 8-K filed on February 2, 2023)

Form of Securities Purchase Agreement, dated March 3, 2023, by and between Unicycive Therapeutics, Inc.

and the purchasers named therein (incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 6, 2023)

Placement Agency Agreement, dated March 3, 2023 by and between Unicycive Therapeutics, Inc.

and EF Hutton, division of Benchmark Investments, LLC (incorporated by reference to Exhibit 10.2 to Form 8-K filed on March 6, 2023)

Form of Amendment No.

1 to Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to Form 8-K filed on April 10, 2023)

Form of Exchange Agreement dated March 13, 2024 by and between Unicycive Therapeutics, Inc.

and the purchasers named therein (incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 14, 2024)

Securities Purchase Agreement, dated March 13, 2024, by and between Unicycive Therapeutics, Inc.

and the purchasers named therein (incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 14, 2024)

Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14.1 to Form 10-K filed on March 31, 2022).

Consent of Mayer Hoffman McCann P.C., independent registered public accounting firm

Consent of Grassi & Co., CPAs, P.C., independent registered public accounting firm

Power of Attorney (included on signature page hereto)

Certification of Principal Executive

Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

Certification of Principal Financial

Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

Certification of Principal Executive

Officer pursuant to 18 U.S.C.

Certification of Principal Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

Certification of Principal Executive Officer pursuant to 18 U.S.C.

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Certification of Principal Financial

Officer pursuant to 18 U.S.C.

Certification of Principal Financial Officer pursuant to 18 U.S.C.

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Clawback Policy

Inline XBRL Instance Document.

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a management contract or any compensatory plan, contract or arrangement.

of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation

S-K Item 601(b)(10)(iv).

of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).

FORM 10-K SUMMARY

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March 28, 2024

/s/ Shalabh Gupta

Shalabh Gupta

Chief Executive Officer (Principal Executive

Officer), President and Chairman of the Board of Directors

Chief Executive Officer (Principal Executive Officer),

President and Chairman of the Board of Directors

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS,

that each person whose signature appears below hereby constitutes and appoints Shalabh Gupta as his or her attorney-in-fact, with full

power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report

on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange

Commission, granting unto said attorney-in-fact full power and authority to do and perform each and every act and thing requisite and

necessary to be done in connection therewith as fully to all intents and purposes as he might or could do in person, hereby ratifying

and confirming all that said attorney-in-fact, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

KNOW ALL PERSONS BY THESE

PRESENTS, that each person whose signature appears below hereby constitutes and appoints Shalabh Gupta as his or her attorney-in-fact,

with full power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all amendments to this

Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities

and Exchange Commission, granting unto said attorney-in-fact full power and authority to do and perform each and every act and thing

requisite and necessary to be done in connection therewith as fully to all intents and purposes as he might or could do in person, hereby

ratifying and confirming all that said attorney-in-fact, or his substitute or substitutes, may lawfully do or cause to be done by virtue

Pursuant to the requirements

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and on the dates indicated.

Chief Executive Officer, President and Chairman of the Board of Directors

March 30, 2023

Shalabh Gupta

Chief Executive Officer,

President and Chairman of the Board of Directors

March 28, 2024

(Principal Executive Officer)

/s/ John Townsend

John Townsend

Chief Financial Officer

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(Principal Financial and Accounting Officer)

/s/ John Ryan,

John Ryan, M.D., Ph.D.

March 28, 2024

John Ryan, M.D., Ph.D.

Sandeep Laumas, M.D.

March 28, 2024

Sandeep Laumas, M.D.

Schiller, M.D.

Saraswati Kenkare-Mitra, Ph.D.

March 28, 2024

Brigitte Schiller, M.D.

/s/ Gaurav Aggarwal, M.D.

Saraswati Kenkare-Mitra,

Gaurav Aggarwal, M.D.

March 28, 2024

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures