Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our “disclosure controls and procedures” as of December 31, 2022, 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, 2022, our management, with the participation of our principal executive officer and
principal financial officer has concluded that, based
on such evaluation, as of the end of the period covered by this Annual Report on Form 10-K ,
our disclosure controls and procedures were not effective due to the material weakness described below. However,
our management, including our principal executive officer and principal financial officer, has concluded that, notwithstanding the identified
material weakness in our internal control over financial reporting, the financial statements in this Annual Report on Form 10-K fairly
present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity
with U.S. GAAP.
Material
Weakness in Internal Controls Over Financial Reporting
We
identified a material weakness in our internal control over financial reporting that exists as of December 31, 2022. A material weakness
is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We determined
that we had a material weakness because, due to our small size, and our limited number of personnel, we did not have in place an effective
internal control environment with formal processes and procedures, including journal entry processing and review, to allow for a detailed
review of accounting transactions that would identify errors in a timely manner.
Notwithstanding
the material weaknesses in our internal control over financial reporting, we have concluded that the consolidated financial statements
included in this Annual Report on Form 10-K fairly present, in all material respects, our financial position, results of operations and
cash flows for the periods presented in conformity with accounting principles generally accepted in the United States of America.
Management’s
Plan to Remediate the Material Weakness
With
the oversight of senior management, we implemented remediation steps in 2021 including addition of accounting consultants and continue
to evaluate and implement procedures that will strengthen our internal controls. We believe these measures will remediate the material
weakness identified and strengthen our internal control over financial reporting. We are committed to continuing to improve our
internal control processes and will continue to diligently review our financial reporting controls and procedures.
Management’s
Annual Report on Internal Control Over Financial Reporting and Auditor Attestation
This
Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting
due to a transition period established by the rules of the SEC for new public companies. In addition, this Annual Report on Form 10-K
does not include an attestation report of our independent registered public accounting firm regarding internal control over financial
reporting as an attestation is not required 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 Reporting
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.
ITEM
9B. OTHER INFORMATION
None.
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not
applicable.
97
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
information required by this item is incorporated by reference to our 2023 Proxy Statement for the 2023 Annual Meeting of Stockholders
to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
ITEM
11. EXECUTIVE COMPENSATION
The
information required by this item is incorporated by reference to our 2023 Proxy Statement for the 2023 Annual Meeting of Stockholders
to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
information required by this item is incorporated by reference to our 2023 Proxy Statement for the 2023 Annual Meeting of Stockholders
to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
information required by this item is incorporated by reference to our 2023 Proxy Statement for the 2023 Annual Meeting of Stockholders
to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information required by this item is incorporated by reference to our 2023 Proxy Statement for the 2023 Annual Meeting of Stockholders
to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
98
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
The
following documents are filed as part of this report:
(1)
Financial
Statements:
Page
Index
to Consolidated Financial Statements:
F-1
Consolidated
Financial Statements:
Report of the Independent Registered Public Accounting Firm (PCAOB ID: 170)
F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021
F-3
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021
F-4
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2022 and
2021
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
F-6
Notes to the Consolidated Financial Statements
F-7
(b)
Exhibits
The
following documents are included as exhibits to this report.
Exhibit
No.
Title
of Document
3.1
Third Amended and Restated Certificate of Incorporation of Immix Biopharma, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 20, 2021)
3.2
Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the SEC on December 20, 2021)
4.1
Specimen Stock Certificate Evidencing the Shares of Common Stock (Incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
4.2
Form of Representative’s Warrant (Incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 28, 2021)
4.3*
Description of the Registrant’s Securities
4.4
Form of Senior Indenture (Incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-3 filed with the SEC on January 3, 2023)
4.5
Form of Subordinated Indenture (Incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-3 filed with the SEC on January 3, 2023)
10.1+
2021 Equity Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
99
10.2+
Form of Indemnification Agreement with Directors and Executive Officers (Incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
10.3#
IP License Agreement by and between the Company and Immix Biopharma Australia Pty Ltd dated January 23, 2017 (Incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
10.4+
Employment Agreement by and between the Company and Ilya Rachman dated June 18, 2021 (Incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
10.5+
Management Services Agreement by and between the Company and Alwaysraise LLC, dated March 18, 2021 (Incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
10.6
Master Service Agreement by and between the Company and AxioMx, Inc. dated December 22, 2014 (Incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
10.7#
Clinical Collaboration and Supply Agreement by and between the Company and BeiGene Switzerland GmbH dated August 20, 2021 (Incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 15, 2021)
10.8+
Amendment to Employment Agreement by and between the Company and Ilya Rachman dated as of November 9, 2022 (Incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2022)
10.9+
Amendment to Master Services Agreement by and between the Company and Alwaysraise, LLC dated as of November 9, 2022 (Incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2022)
10.10#
Research and License Agreement entered into on December 8, 2022 by and between Nexcella, Inc. (formerly Immix Biopharma Cell Therapy, Inc.), Hadasit Medical Research Services & Development, Ltd. and BIRAD Research and Development Company Ltd. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 14, 2022)
10.11
Form of Share Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 18, 2023)
10.12*
Senior Unsecured Promissory Note issued by Nexcella, Inc. to Immix Biopharma, Inc. on December 21, 2022
10.13+
2016 Equity Incentive Plan (Incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 6, 2021)
14.1*
Code of Business Conduct and Ethics (Incorporated by reference to Exhibit 14.1 to the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2022)
21.1*
Subsidiaries
23.1*
Consent of KMJ Corbin & Company LLP, independent registered public accounting firm
24.1*
Power of Attorney (included on signature page hereto)
100
31.1*
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of the Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
104*
Cover
Page Interactive Data File – the cover page of the Registrant’s Annual Report on Form 10-K for the year ended December
31, 2022 is formatted in Inline XBRL
*
Filed herewith.
** Furnished herewith.
+
Management contract or compensatory plan or arrangement.
#
Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions
with an asterisk because the Company customarily and actually treats such information as private
or confidential and such omitted information is not material.
ITEM
16. FORM 10-K SUMMARY
None.
101
SIGNATURES
Pursuant
to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report
on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized on this 27 th day of March, 2023.
IMMIX
BIOPHARMA, INC.
/s/
Ilya Rachman
Ilya
Rachman
Chief
Executive Officer (Principal Executive Officer) 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 Ilya Rachman 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 Annual Report on Form 10-K 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/
Ilya Rachman
Chief
Executive Officer (Principal Executive Officer) and Chairman of the Board of Directors
March
27, 2023
Ilya
Rachman
/s/
Gabriel Morris
Chief
Financial Officer and Director
March
27, 2023
Gabriel
Morris
(Principal
Financial and Accounting Officer)
/s/
Jason Hsu
Director
March
27, 2023
Jason
Hsu
/s/
Magda Marquet
Director
March
27, 2023
Magda
Marquet
/s/
Helen C. Adams
Director
March
27, 2023
Helen
C. Adams
/s/
Carey Ng
Director
March
27, 2023
Carey
Ng
/s/
Jane Buchan
Director
March
27, 2023
Jane
Buchan
102