Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
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, 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. GAAP. 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
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
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, 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.
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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; 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.
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
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. 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.
ITEM 9B. OTHER INFORMATION
None .
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS.
Not applicable.
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PART III
ITEM 10. 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 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. Our
insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference
from the information contained in the 2025 Proxy Statement under the heading “Executive Compensation.”
ITEM 12. 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.”
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by this item is incorporated by reference
from the information contained in the 2025 Proxy Statement under the heading “Certain Transactions.”
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
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.”
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)
The following documents are filed as part of this report:
(1)
Financial Statements:
The financial statements required by this
Item are included beginning at page F-1.
(2)
Financial Statement Schedules:
All financial statement schedules have been omitted
because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
(b) Exhibits
The following documents are included as exhibits to this report.
Exhibit No.
Description
1.1
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)
3.1
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)
3.2
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)
3.3
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.5 to Amendment No. 2 to Form S-1 filed on June 21, 2021)
3.4
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)
3.5
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)
3.6
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)
3.7
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)
3.8
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)
3.9
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)
3.10
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)
3.11
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).
3.12
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
4.1
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)
4.2
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)
4.3
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)
4.4*
Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
4.5
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)
4.6
Form of Tranche A Warrant (incorporated by reference to Exhibit 4.2 to Form 8-K filed on March 6, 2023)
4.7
Form of Tranche B Warrant (incorporated by reference to Exhibit 4.3 to Form 8-K filed on March 6, 2023)
4.8
Form of Tranche C Warrant (incorporated by reference to Exhibit 4.4 to Form 8-K filed on March 6, 2023)
4.9
Form of Amended and Restated Tranche A Warrant (incorporated by reference to Exhibit 4.1 to Form 8-K filed on March 14, 2024)
4.10
Form of Amended and Restated Tranche B Warrant (incorporated by reference to Exhibit 4.2 to Form 8-K filed on March 14, 2024)
4.11
Form of Amended and Restated Tranche C Warrant (incorporated by reference to Exhibit 4.3 to Form 8-K filed on March 14, 2024)
10.1+
2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to Amendment No. 1 to Form S-1 filed on June 7, 2021)
10.2+
2019 Stock Option Plan (incorporated by reference to Exhibit 10.2 to Amendment No. 1 to Form S-1 filed on June 7, 2021)
10.3+
2021 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Form S-1 filed on June 7, 2021)
10.4
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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10.5
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)
10.6
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)
10.7+
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)
10.8+
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)
10.9+
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)
10.10#
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)
10.11#
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)
10.12#
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)
10.13
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)
10.14
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)
10.15
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)
10.16
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)
10.17
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)
10.18+
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
10.19
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)
10.20
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)
10.21+
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)
14.1
Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14.1 to Form 10-K filed on March 31, 2022).
19.1*
Insider Trading Policy
23.1*
Consent of Grassi & Co., CPAs, P.C., independent registered public accounting firm
24.1
Power of Attorney (included on signature page hereto)
31.1*
Certification of Principal Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
31.2*
Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
32.1*
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.
32.2*
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.
97.1
Clawback Policy (incorporated by reference to Exhibit 97.1 to Form 10-K filed on March 28, 2024
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase.
101.LAB*
Inline XBRL Taxonomy Extension Labels Linkbase.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
+
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
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
UNICYCIVE THERAPEUTICS, INC.
March 31, 2025
/s/ Shalabh Gupta
Shalabh Gupta
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.
Pursuant to the requirements
of the Securities Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
Signature
Title
Date
/s/ Shalabh Gupta
Chief Executive Officer, President and Chairman of the Board of Directors
March 31, 2025
Shalabh Gupta
(Principal Executive Officer)
/s/ John Townsend
Chief Financial Officer
March 31, 2025
John Townsend
(Principal Financial and Accounting Officer)
/s/ Sandeep Laumas, M.D.
Director
March 31, 2025
Sandeep Laumas, M.D.
/s/ Saraswati Kenkare-Mitra, Ph.D.
Director
March 31, 2025
Saraswati Kenkare-Mitra, Ph.D.
/s/ Gaurav Aggarwal, M.D.
Director
March 31, 2025
Gaurav Aggarwal, M.D.
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