What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-03-31 compared with 2024-03-28 · 149 added, 137 removed, 120 unchanged (70% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls

Our principal executive officer and principal

financial officer evaluated the effectiveness of our “disclosure controls and procedures” as of December 31, 2023, the end

of the period covered by this Annual Report on Form 10-K.

The term “disclosure controls and procedures” as defined in Rules

13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information

required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported,

within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation,

controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files under

the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer and principal

financial officer, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating the disclosure

controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, cannot provide

absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that

all control issues and instances of fraud, if any, within a company have been detected.

Based on the evaluation of our disclosure controls

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

of unusual or infrequent transactions with complex or infrequently applied accounting topics resulted in the insufficient level of supervision,

review and approval of certain information used to prepare our financial statements and the maintenance of effective controls to adequately

monitor and review significant transactions for financial statement completeness and accuracy.

These control deficiencies, although varying

in severity, contributed to the material weakness in the control environment.

If one or more material weaknesses persist or if we fail

to establish and maintain effective internal control over financial reporting, our ability to accurately report our financial results

could be adversely affected.

The above material weakness did not result in

a material misstatement of our previously issued financial statements, however, it could result in a misstatement of our account balances

or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented

Management is taking steps to remediate the material

weakness in our internal control over financial reporting.

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

Our principal executive officer and principal financial officer evaluated

the effectiveness of our “disclosure controls and procedures” as of December 31, 2024, the end of the period covered by this

Annual Report on Form 10-K.

The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under

the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed

by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported, within the time periods

specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures

designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is accumulated

and communicated to a company’s management, including its principal executive officer and principal financial officer, as appropriate

to allow timely decisions regarding required disclosure.

In designing and evaluating the disclosure controls and procedures, management

recognizes that any controls and procedures, no matter how well designed and operated, cannot provide absolute assurance that the objectives

of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of

fraud, if any, within a company have been detected.

Based on the evaluation of our disclosure controls and procedures as of December

31, 2024, our Chief Executive Officer and our Chief Financial Officer determined that we maintained effective internal control over financial

reporting as of December 31, 2024.

Management Report on Internal Control Over

Financial Reporting

Our management is responsible for establishing and maintaining adequate

internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f).

Internal control over financial

reporting is a process designed under the supervision and with the participation of our management, including our principal executive

officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation

of financial statements for external purposes in accordance with U.S.

All internal control systems, no matter how well designed,

have inherent limitations.

Therefore, even those systems determined to be effective can provide only reasonable assurance with respect

to financial statement preparation and presentation.

As of December 31, 2024, under the supervision and with the participation

of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness

of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal

Control-Integrated Framework - 2013.

Based on this assessment, our management concluded that, as of December 31, 2024, our internal control

over financial reporting was effective.

This Annual Report on Form 10-K does not include an attestation report

of our registered public accounting firm regarding internal control over financial reporting.

Management’s report was not subject

to attestation by the Company’s registered public accounting firm pursuant to the exemption provided to issuers that are not “large

accelerated filers” nor “accelerated filers” under the Dodd-Frank Wall Street Reform and Consumer Protection Act.

Status of Remediation of Material Weaknesses in Internal Control

over Financial Reporting

Our management is responsible for establishing

and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f).

control over financial reporting is a process designed under the supervision and with the participation of our management, including

our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial

reporting and the preparation of financial statements for external purposes in accordance with U.S.

All internal control systems,

no matter how well designed, have inherent limitations.

Therefore, even those systems determined to be effective can provide only reasonable

assurance with respect to financial statement preparation and presentation.

As of December 31, 2023, under the supervision

As previously disclosed, as of December 31, 2023, under the supervision

and with the participation of our management, including our principal executive officer and principal financial officer, we conducted

1 unchanged sentence

of the Treadway Commission in Internal Control-Integrated Framework - 2013.

Based on this assessment, our management concluded that,

as of December 31, 2023, our internal control over financial reporting was not effective due to a material weakness in our internal control

over financial reporting as discussed above in our evaluation of disclosure controls.

Based on this assessment, our management concluded that, as

of December 31, 2023, our internal control over financial reporting was not effective because management identified a material weakness.

A material weakness is a significant deficiency or a combination of significant deficiencies in internal control over financial reporting

such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented

or detected on a timely basis.

Specifically, we lacked 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.

The lack of adequate staffing levels and expertise of unusual or infrequent

transactions with complex or infrequently applied accounting topics resulted in the insufficient level of supervision, review and approval

of certain information used to prepare our financial statements and the maintenance of effective controls to adequately monitor and review

significant transactions for financial statement completeness and accuracy.

These control deficiencies, although varying in severity,

contributed to the material weakness in the control environment during 2023.

If one or more material weaknesses persist or if we fail

to establish and maintain effective internal control over financial reporting, our ability to accurately report our financial results

could be adversely affected.

To address the material weakness described above, we have:

● Increased the number of accounting personnel;

● Engaged third party experts to assist management in analyses

and conclusions involving complex or infrequently applied accounting treatment;

● Engaged third party experts to assist management in completing

a comprehensive risk assessment to identify, design and implement control activities.

In addition, we have taken steps to review and enhance business policies,

procedures and related internal controls to standardize business processes.

Changes in Internal Control Over Financial Reporting

As noted above, as of December 31, 2023, our internal control over

financial reporting was not effective because management identified a material weakness.

The lack of adequate staffing levels and expertise

2 unchanged sentences

monitor and review significant transactions for financial statement completeness and accuracy.

These control deficiencies, although varying

in severity, contributed to the material weakness in the control environment.

If one or more material weaknesses persist or if we fail

to establish and maintain effective internal control over financial reporting, our ability to accurately report our financial results

could be adversely affected.

In light of the material weakness, we performed

additional analysis and other post-closing procedures to ensure the reliability of financial reporting and that our financial statements

were prepared in accordance with U.S.

Accordingly, we believe that the financial statements included in this report fairly present,

in all material respects, our financial condition, results of operations and cash flows for the periods presented.

Management is taking steps to remediate the material

weakness in our internal control over financial reporting.

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.

This Annual Report on Form 10-K does not include

an attestation report of our registered public accounting firm regarding internal control over financial reporting.

report was not subject to attestation by the Company’s registered public accounting firm pursuant to the exemption provided to

issuers that are not “large accelerated filers” nor “accelerated filers” under the Dodd-Frank Wall Street Reform

and Consumer Protection Act.

Changes in Internal Control Over Financial

There have been no changes in our internal control

over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially

affect, our internal control over financial reporting.

To address the material weakness in 2024,

we have increased the number of accounting personnel, engaged third party experts to assist management in analyses and conclusions involving

complex or infrequently applied accounting treatment, and engaged third party experts to assist management in completing a comprehensive

risk assessment to identify, design and implement control activities.

In addition, we have taken steps to review and enhance business

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

There have been no other changes in our internal

control over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely

to materially affect, our internal control over financial reporting.

OTHER INFORMATION

DISCLOSURE REGARDING FOREIGN JURISDICTIONS

THAT PREVENT INSPECTIONS.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item is incorporated

by reference from the information contained in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission

in connection with the Annual Meeting of Stockholders to be held in 2024 (the “2024 Proxy Statement”), under the heading

“Election of Directors.”

The information required by this item is incorporated by reference

from the information contained in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission in connection

with the Annual Meeting of Stockholders to be held in 2025 (the “2025 Proxy Statement”), under the heading “Election

of Directors.”

We have adopted a code of business conduct and ethics that applies

to all our employees, officers and directors, including those officers responsible for financial reporting.

Our code of business conduct

and ethics is available on the investors section of our website.

We intend to satisfy the disclosure requirement under Item 5.05 of Form

8-K regarding amendment to, or waiver from, a provision of our Code of Conduct by posting such information on the website address and

location specified above.

We have adopted an insider trading policy applicable to our

directors, officers, employees, and other covered persons, and have implemented processes for the company, that we believe are reasonably

designed to promote compliance with insider trading laws, rules and regulations, and the Nasdaq Capital Market listing standards.

insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.

EXECUTIVE COMPENSATION

The information required by this item is incorporated

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

The information required by this item is incorporated

by reference from the information contained in the 2024 Proxy Statement under the headings “Security Ownership of Certain Beneficial

Owners and Management and Related Stockholder Matters.”

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.”

The information required by this item is incorporated by reference

from the information contained in the 2025 Proxy Statement under the heading “Executive Compensation.”

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

AND RELATED STOCKHOLDER MATTERS

The information required by this item is incorporated by reference

from the information contained in the 2025 Proxy Statement under the heading “Security Ownership of Certain Beneficial Owners and

Management and Related Stockholder Matters.”

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR

The information required by this item is incorporated by reference

from the information contained in the 2025 Proxy Statement under the heading “Certain Transactions.”

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this item is incorporated

by reference from the information contained in the 2024 Proxy Statement under the heading “Proposal 2:

Ratification of the Appointment

of Our Independent Registered Public Accounting Firm for Fiscal Year Ending December 31, 2024.”

The information required by this item is incorporated by reference

from the information contained in the 2025 Proxy Statement under the heading “Proposal 2:

Ratification of the Appointment of Our

Independent Registered Public Accounting Firm for Fiscal Year Ending December 31, 2025.”

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

The following documents

are filed as part of this report:

The following documents are filed as part of this report:

Financial Statements:

5 unchanged sentences

The following documents are included as exhibits to this report.

Sales Agreement, dated as of November 13, 2024, between the Company and Guggenheim Securities, LLC (incorporated by reference to Exhibit 1.1 of Form S-3 filed on November 13, 2024)

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

10 unchanged sentences

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)

Certificate of Amendment to Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Form 8-K filed on June 26, 2024).

Certificate of Correction to Series B Preferred Certificate of Designation filed with the Delaware Secretary of State on November 8, 2024, incorporated by reference to Exhibit 3.1 to Form 10-Q for the period ended September 30, 2024 filed on November 13, 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)

3 unchanged sentences

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).

Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934

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)

12 unchanged sentences

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

License Agreement by and between the Company and Sphaera Pharma Pte.

Ltd., dated October 1, 2017 (incorporated by reference to Exhibit

10.5 to Amendment No.

Exclusive License Agreement by and between the Company and Sphaera Pharma Pte.

Ltd., dated October 1, 2017 (incorporated by reference to Exhibit 10.5 to Amendment No.

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

23 unchanged sentences

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

Second Amended and Restated 2021 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit C to registrant’s Proxy Statement on Schedule 14A filed on April 26, 2024

Manufacturing and Supply Agreement dated as of October 31, 2020 by and between Unicycive Therapeutics, Inc.

and Shilpa Medicare Ltd.

(incorporated by reference to Exhibit 10.1 to Form 10-Q filed on August 14, 2024)

First Amendment to Manufacturing and Supply Agreement dated June 25, 2024 by and between Unicycive Therapeutics, Inc.

and Shilpa Medicare Ltd.

(incorporated by reference to Exhibit 10.2 to Form 10-Q filed on August 14, 2024)

Employment Agreement (this “Agreement”), dated August 12, 2024, by and among Unicycive Therapeutics Inc.

and Doug Jermasek.

(incorporated by reference to Exhibit 10.3 to Form 10-Q filed on August 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

Insider Trading Policy

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

6 unchanged sentences

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

Clawback Policy

Clawback Policy (incorporated by reference to Exhibit 97.1 to Form 10-K filed on March 28, 2024

Inline XBRL Instance Document.

5 unchanged sentences

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

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).

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

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

Filed herewith

FORM 10-K SUMMARY

4 unchanged sentences

March 31, 2025

/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

1 unchanged sentence

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

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.

Pursuant to the requirements

1 unchanged sentence

and on the dates indicated.

Shalabh Gupta

Chief Executive Officer,

President and Chairman of the Board of Directors

/s/ Shalabh Gupta

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

March 31, 2025

Shalabh Gupta

(Principal Executive Officer)

John Townsend

/s/ John Townsend

Chief Financial Officer

2 unchanged sentences

(Principal Financial and Accounting Officer)

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

/s/ Sandeep Laumas, M.D.

March 31, 2025

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

Sandeep Laumas, M.D.

/s/ Saraswati Kenkare-Mitra, Ph.D.

March 31, 2025

Sandeep Laumas, M.D.

Saraswati Kenkare-Mitra, Ph.D.

March 28, 2024

Saraswati Kenkare-Mitra,

Gaurav Aggarwal, M.D.

/s/ Gaurav Aggarwal, M.D.

March 31, 2025

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