Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. Under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2021 to ensure that the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 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 us in the reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate, to allow timely decisions regarding required disclosure. Our management, with participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2021. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2021 to provide reasonable assurance that the information required to be disclosed by us in this Annual Report was (a) reported within the time periods specified by SEC rules and regulations and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding any required disclosure.
Management’s 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 Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our principal executive, financial and accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2021 based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2021.
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Cybersecurity
We utilize information technology for internal and external communications with vendors, clinical sites, banks, investors and shareholders. Loss, disruption or compromise of these systems could significantly impact operations and results.
We are not aware of any material cybersecurity violation or occurrence. We believe our efforts toward prevention of such violation or occurrence, including system design and controls, processes and procedures, training and monitoring of system access, limit, but may not prevent unauthorized access to our systems.
Other than temporary disruption to operations that may be caused by a cybersecurity breach, we consider cash transactions to be the primary risk for potential loss. We and our financial institution take steps to minimize the risk by requiring multiple levels of authorization and other controls.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the fiscal quarter ended December 31, 2021 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Internal Controls
In designing and evaluating the disclosure controls and procedures, management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
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 and not set forth below will be set forth in the sections headed “Election of Directors,” “Executive Officers” and “Delinquent Section 16(a) Reports” in our definitive proxy statement for our 2021 Annual Meeting of Stockholders, or our Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2021 and is incorporated herein by reference.
We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial and accounting officer or controller, or persons performing similar functions, known as the Code of Ethics and Business Conduct. The Code of Ethics and Business Conduct is available on our website at www.markertherapeutics.com under the Corporate Governance section of our Investors page. If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item will be set forth in the section headed “Securities Authorized for Issuance Under Equity Compensation Plans” and “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated herein by reference.
The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation " and "Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The information required by this item will be set forth in the section headed “Transactions with Related Persons and Indemnification” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item will be set forth in the section headed “Principal Accountant Fees and Services” in our Proxy Statement and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) The documents filed as part of this report are as follows:
1. The financial statements and accompanying report of independent registered public accounting firm are set forth immediately following the signature page of this report on pages F-1 through F-22.
2. All financial statement schedules are omitted because they are inapplicable, not required or the information is included elsewhere in the financial statements or the notes thereto.
3. The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
EXHIBIT INDEX
Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
3.1
Certificate of Incorporation
8-K
001-37939
3.4
10/17/18
3.2
Bylaws of Marker Therapeutics, Inc.
8-K
000-37939
3.6
10/17/18
4.0
Form of Common Stock Certificate of Marker Therapeutics, Inc.
8-A/A
000-37939
4.1
10/17/18
4.24
Form of Marker Warrant
8-K
001-37939
2.1
5/15/18
4.25
Description of Common Stock of Marker Therapeutics, Inc.
10-K
001-37939
4.25
3/12/20
10.1
Form of Restructuring Agreement dated May 28, 2015
8-K
000-27239
10.1
6/3/15
10.2
Amended and Restated Restructuring Agreement, dated as of June 2, 2015
8-K
000-27239
10.1
6/5/15
10.3
Form of Securities Purchase Agreement (including registration rights)
8-K
001-37939
10.1
6/8/18
10.4
Registration Rights Agreement
8-K
001-37939
2.1
5/15/18
10.5
License and Assignment Agreement, dated July 21, 2015, with The Mayo Foundation for Medical Education and Research**
10-Q
000-27239
10.1
8/14/15
10.6
License and Assignment Agreement with Mayo Foundation for Medical Education and Research dated May 19, 2016**
10-Q
000-27239
10.1
8/15/16
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Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
10.7
Exclusive License Agreement between Baylor College of Medicine and Marker Therapeutics, Inc. dated March 16, 2018***
10-K
001-37939
10.21
3/15/19
10.8
Sponsored Research Contract between Baylor College of Medicine and Marker Therapeutics, Inc. dated November 16, 2018***
10-K
001-37939
10.22
3/15/19
10.9
2009 Stock Incentive Plan*
DEF14-C
000-27239
B
1/29/10
10.10
2014 Omnibus Stock Ownership Plan, as amended through August 29, 2017*
8-K
001-37939
10.1
9/5/17
10.11
Amendment to 2014 Omnibus Stock Ownership Plan, as amended *
8-K
001-37939
4.4
10/17/18
10.12
Form of Stock Option Award Agreement –Employee*
8-K
001-37939
10.3
10/23/18
10.13
Form of Stock Option Award Agreement – Non-Employee Director*
S-8
333-228056
10.1
10/30/18
10.14
Form of Stock Option Award Agreement – Consultant*
8-K
001-37939
10.2
10/23/18
10.15
Form of Restricted Stock Award Agreement – Consultant*
10-Q
000-27239
10.7
11/16/15
10.16
Employment Agreement between TapImmune Inc. and Peter Hoang dated as of September 22, 2017*
8-K
001-37939
10.1
9/25/17
10.17
Employment Agreement by and between TapImmune Inc. and Michael J. Loiacono dated as of August 25, 2016*
8-K
000-27239
10.1
8/25/16
10.18
Amendment to Employment Agreement between Marker Therapeutics, Inc. and Michael J. Loiacono dated as of November 27, 2018*
8-K
001-37939
10.2
12/3/18
10.19
Employment Agreement between Marker Therapeutics, Inc. and Anthony Kim dated as of November 27, 2018*
8-K
001-37939
10.3
12/3/18
10.20
Consulting Agreement between Dr. Juan Vera and Marker Therapeutics, Inc. dated October 19, 2018*
8-K
001-37939
10.1
10/23/18
10.21
Form of Director and Officer Indemnification Agreement*
10-K
001-37939
10.39
3/15/19
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Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
10.22
Amendment to Employment Agreement between Marker Therapeutics, Inc. and Peter Hoang, dated March 14, 2019*
10-K
001-37939
10.40
3/15/19
10.23
Employment Agreement between Marker Therapeutics, Inc. and Mythili Koneru, dated February 6, 2019.*
10-Q
001-37939
10.3
5/10/19
10.24
Marker Therapeutics, Inc. 2020 Equity Incentive Plan
S-8
333-239136
99.1
6/12/20
10.25
Form of Stock Option Grant Notice and Stock Option Agreement under the Marker Therapeutics, Inc. 2020 Equity Incentive Plan.
10-Q
001-37939
10.1
11/9/20
10.26
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Marker Therapeutics, Inc. 2020 Equity Incentive Plan.
10-Q
001-37939
10.2
11/9/20
10.27
Form of Common Stock Purchase Warrant
8-K
000-27239
4.1
8/14/14
10.28
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series A
8-K
000-27239
4.6
1/12/15
10.29
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series C
8-K
000-27239
4.8
1/12/15
10.30
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series D
8-K
000-27239
4.9
1/12/15
10.31
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series E
8-K
000-27239
4.10
1/12/15
10.32
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series A-1
8-K
000-27239
4.6
3/10/15
10.33
Form of Placement Agent Warrant Common Stock Purchase Warrants-Series E-1
8-K
000-27239
4.10
3/10/15
10.34
Form of Amended Series A Warrant
8-K
000-27239
4.2
8/11/16
10.35
Form of Amended Series C Warrant
8-K
000-27239
4.3
8/11/16
10.36
Form of Amended Series D Warrant
8-K
000-27239
4.4
8/11/16
10.37
Form of Amended Series E Warrant
8-K
000-27239
4.5
8/11/16
10.38
Form of Amended Series A-1 Warrant
8-K
000-27239
4.6
8/11/16
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Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
10.39
Form of Amended Series D-1 Warrant
8-K
000-27239
4.7
8/11/16
10.40
Form of Series F Warrant
8-K
000-27239
4.9
8/11/16
10.41
Form of Series F-1 Warrant
8-K
000-27239
4.10
8/11/16
10.42
Form of August 2016 Private Placement Warrant
8-K
000-27239
4.1
8/11/16
10.43
Form of 2016 Private Placement Agent Warrant
8-K
000-27239
4.11
8/11/16
10.44
Form of June 2017 Private Placement Warrant
8-K
001-37939
4.1
6/22/17
10.45
Form of 2017 Private Placement Agent Warrant
8-K
001-37939
4.2
6/22/17
10.46
Form of Warrant Amendment Agreement August 2016 Private Placement
8-K
000-27239
10.3
8/11/16
10.47
Form of Warrant Exercise Agreement
8-K
001-37939
10.3
6/22/17
10.48
Form of Private Placement Warrant
8-K
001-37939
4.1
6/8/18
10.49
Form of Private Placement Warrant
8-K
001-37393
4.2
6/8/18
21.1
List of Subsidiaries
X
23.1
Consent of Marcum LLP, an independent public accounting firm.
X
24.1
Powers of Attorney (included on signature page)
X
31.1
Certification of Chief Executive Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
X
31.2
Certification of Chief Financial Officer pursuant to Securities Exchange Act of 1934 Rule 13a-14(a) or 15d-14a
X
32.1
Certification of Chief Executive Officer pursuant to 18 U. S. C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002#
X
32.2
Certification of Chief Financial Officer pursuant to 18 U. S. C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002#
X
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Incorporated by Reference
Exhibit
number
Exhibit description
Form
File no.
Exhibit
Filing
date
Filed
herewith
101.INS
XBRL Instance Document
X
101.SCH
XBRL Taxonomy Extension Schema Document
X
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 filed herewith)
* Executive management contract or compensatory plan or arrangement.
** Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
*** Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for conditional treatment and this exhibit has been submitted separately with the SEC.
# These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C. Section 1350 and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 and 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.
Dated: March 17, 2022
Marker Therapeutics, Inc.
By:
/s/ Peter Hoang
Peter Hoang
Chief Executive Officer (Principal Executive Officer)
By:
/s/ Anthony Kim
Anthony Kim
Chief Financial Officer (Principal Financial and Accounting Officer)
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Table of Contents
POWER OF ATTORNEY
Each of the undersigned officers and directors of Marker Therapeutics, Inc., hereby constitutes and appoints Peter Hoang and Anthony Kim, their true and lawful attorney-in-fact and agent, for them and in their name, place and stead, in any and all capacities, to sign their name to any and all amendments to this Report on Form 10-K, and other related documents, and to cause the same to be filed with the Securities and Exchange Commission, granting unto said attorneys, full power and authority to do and perform any act and thing necessary and proper to be done in the premises, as fully to all intents and purposes as the undersigned could do if personally present, and the undersigned for himself hereby ratifies and confirms all that said attorney shall lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on March 17, 2022 on behalf of the registrant and in the capacities indicated.
Signature
Title
Date
/s/ Peter Hoang
President, Chief Executive Officer and Director (Principal Executive Officer)
March 17, 2022
Peter Hoang
/s/ Frederick Wasserman
Director
March 17, 2022
Frederick Wasserman
/s/ David Laskow-Pooley
Director
March 17, 2022
David Laskow-Pooley
/s/ John Wilson
Director
March 17, 2022
John Wilson
/s/ Juan Vera
Director
March 17, 2022
Juan Vera
/s/ N. David Eansor
Director
March 17, 2022
N. David Eansor
/s/ Steve Elms
Director
March 17, 2022
Steve Elms
/s/ Katharine Knobil
Director
March 17, 2022
Katharine Knobil
/s/ Anthony Kim
Chief Financial Officer (Principal Financial and Accounting Officer)
March 17, 2022
Anthony Kim
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MARKER THERAPEUTICS, INC.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2021 AND DECEMBER 31, 2020
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 688 )
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Stockholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to the Consolidated Financial Statements
F-7
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
Marker Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Marker Therapeutics, Inc. (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred significant losses and needs to raise additional funds to sustain its operating expenses and capital expenditure requirements. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since 2014 .
Houston TX
March 17, 2022
F-2
Table of Contents
MARKER THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
42,351,145
$
21,352,382
Restricted cash
1,146,186
—
Prepaid expenses and deposits
2,484,634
2,057,924
Other receivables
237
1,000,559
Total current assets
45,982,202
24,410,865
Non-current assets:
Property, plant and equipment, net
10,096,861
3,570,736
Construction in progress
2,225,610
6,789,098
Right-of-use assets, net
9,830,461
10,844,116
Total non-current assets
22,152,932
21,203,950
Total assets
$
68,135,134
$
45,614,815
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
11,134,913
$
6,013,010
Lease liability
620,490
388,792
Deferred revenue
1,146,186
—
Total current liabilities
12,901,589
6,401,802
Non-current liabilities:
Lease liability, net of current portion
11,247,950
11,868,440
Total non-current liabilities
11,247,950
11,868,440
Total liabilities
24,149,539
18,270,242
Stockholders' equity:
Preferred stock - $ 0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2021 and 2020, respectively
—
—
Common stock, $ 0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of December 31, 2021 and 2020, respectively
83,079
50,731
Additional paid-in capital
442,020,871
383,533,326
Accumulated deficit
( 398,118,355 )
( 356,239,484 )
Total stockholders' equity
43,985,595
27,344,573
Total liabilities and stockholders' equity
$
68,135,134
$
45,614,815
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Table of Contents
MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended
December 31,
2021
2020
Revenues:
Grant income
$
1,241,710
$
466,785
Total revenues
1,241,710
466,785
Operating expenses:
Research and development
27,794,879
18,880,751
General and administrative
12,924,826
10,471,846
Total operating expenses
40,719,705
29,352,597
Loss from operations
( 39,477,995 )
( 28,885,812 )
Other income:
Change in fair value of warrant liabilities
—
31,000
Arbitration settlement
( 2,406,576 )
—
Interest income
5,700
148,742
Net loss
$
( 41,878,871 )
$
( 28,706,070 )
Net loss per share, basic and diluted
$
( 0.55 )
$
( 0.61 )
Weighted average number of common shares outstanding, basic and diluted
76,505,675
47,039,862
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Total
Common Stock
Additional Paid-
Accumulated
Stockholders'
Shares
Par value
in Capital
Deficit
Equity
Balance at January 1, 2020
45,728,831
$
45,728
$
371,573,909
$
( 327,533,414 )
$
44,086,223
Issuance common stock for cash
4,113,440
4,114
6,181,897
—
6,186,011
Warrants exercised for cash
458,334
459
549,541
—
550,000
Issuance of common stock as commitment fee for future financing
345,357
345
( 345 )
—
—
Stock-based compensation
85,110
85
5,228,324
—
5,228,409
Net loss
—
—
—
( 28,706,070 )
( 28,706,070 )
Balance at December 31, 2020
50,731,072
50,731
383,533,326
( 356,239,484 )
27,344,573
Issuance of common stock for cash (net of offering costs of $ 3.9 million)
32,282,857
32,283
52,520,475
—
52,552,758
Stock options exercised for cash
1,456
2
3,085
—
3,087
Stock-based compensation
63,290
63
5,963,985
—
5,964,048
Net loss
—
—
—
( 41,878,871 )
( 41,878,871 )
Balance at December 31, 2021
83,078,675
$
83,079
$
442,020,871
$
( 398,118,355 )
$
43,985,595
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
MARKER THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended
December 31,
2021
2020
Cash Flows from Operating Activities:
Net loss
$
( 41,878,871 )
$
( 28,706,070 )
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization
2,148,983
485,641
Changes in fair value of warrant liabilities
—
( 31,000 )
Stock-based compensation
5,964,048
5,228,409
Amortization on right-of-use assets
1,013,655
590,039
Changes in operating assets and liabilities:
Prepaid expenses and deposits
( 426,710 )
( 531,482 )
Other receivables
1,000,322
55,630
Accounts payable and accrued expenses
4,141,414
3,047,410
Deferred revenue
1,146,186
—
Lease liability
( 388,792 )
( 173,268 )
Net cash used in operating activities
( 27,279,765 )
( 20,034,691 )
Cash Flows from Investing Activities:
Purchase of property and equipment
( 1,572,161 )
( 3,422,754 )
Purchase of construction in progress
( 1,558,970 )
( 5,830,133 )
Net cash used in investing activities
( 3,131,131 )
( 9,252,887 )
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net
52,552,758
6,186,011
Proceeds from exercise of warrants
—
550,000
Proceeds from exercise of stock options
3,087
—
Net cash provided by financing activities
52,555,845
6,736,011
Net increase (decrease) in cash, cash equivlants and restricted cash
22,144,949
( 22,551,567 )
Cash, cash equivalents and restricted cash at beginning of the year
21,352,382
43,903,949
Cash, cash equivalents and restricted cash at end of the year
$
43,497,331
$
21,352,382
For the Years Ended
December 31,
2021
2020
Supplemental schedule of non-cash financing and investing activities:
Reclassifications between construction in progress and fixed assets
$
6,789,098
$
—
Capital expenditures included in accounts payable
$
2,160,765
$
1,180,276
Issuance of common stock as commitment fee for future financing
$
—
$
345
Recognition of right-of-use assets and lease liability from new operating lease agreement
$
—
$
11,114,300
The accompanying notes are an integral part of these consolidated financial statements.
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MARKER THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE FISCAL YEARS DECEMBER 31, 2021 AND 2020
NOTE 1: NATURE OF OPERATIONS
Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The Company’s MultiTAA-specific T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.
NOTE 2: FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
As of December 31, 2021, the Company had cash, cash equivalents and restricted cash of approximately $ 43.5 million. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity and debt financings.
On March 16, 2021, the Company issued an aggregate of 32,282,857 shares of its common stock, for net proceeds of $ 52.6 million.
In August 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the "ATM Agreement") with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (the "Sales Agents"), pursuant to which the Company can offer and sell, from time to time at its sole discretion through the Sales Agents, shares of its common stock having an aggregate offering price of up to $ 75.0 million. Any shares of its common stock sold will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-258687), which the SEC declared effective on August 19, 2021. The Sales Agents will be entitled to compensation under the Sales Agreement at a commission rate equal to 3.0 % of the gross sales price per share sold under the ATM Agreement, and the Company has provided each of the Sales Agents with indemnification and contribution rights. To date, the Company has not sold any shares of its common stock under the ATM Agreement.
In August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from the Cancer Prevention and Research Institute of Texas ("CPRIT") to support the Company's Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the Company's Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group. To date, the Company has received $ 2.4 million of funds from the CPRIT grant. The Company recorded $ 1.2 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2021. At December 31, 2021 , $ 1.1 million was recorded as Restricted Cash and Deferred Revenue on the Company’s consolidated financial statements.
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The Company expects to continue to incur substantial losses over the next several years during its development phase. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved.
Based on the Company’s clinical and research and development plans and its timing expectations related to the progress of its programs, the Company expects that its cash, cash equivalents and restricted cash as of December 31, 2021 will enable the Company to fund its operating expenses and capital expenditure requirements into the first quarter of 2023, as such these factors raise substantial doubt regarding the Company's ability to continue as a going concern. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it:
● initiates or continues clinical trials of its product candidates;
● continues the research and development of its product candidates and seeks to discover additional product candidates;
● seeks regulatory approvals for any product candidates that successfully complete clinical trials;
● maintains and enforces intellectual property rights;
● establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;
● evaluates strategic transactions the Company may undertake; and
● enhances operational, financial and information management systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate is approved, commercialization efforts.
These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on a going concern basis, which implies that the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the COVID-19 pandemic. However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs. The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the emergence of any new variant strains of COVID-19, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements, the timing, distribution, rate of public acceptance and efficacy of vaccines and other treatments, and business closures in the United States and other countries to contain and treat the disease. While the potential economic impact brought by, and the duration of the COVID-19 pandemic may be difficult to assess or predict it could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 and any variant strains thereof could materially affect the Company’s business and the value of its common stock.
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NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America. Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All significant intercompany balances and transactions are eliminated upon consolidation.
Prior Period Reclassification
Certain reclassifications have been made to reclass certain non-cash capital expenditures on the consolidated statements of cash flows from a cash outflow from investing activity to a non-cash investing activity. The Company has evaluated the materiality of this adjustment and concluded it was not material to the previously issued consolidated financial statements and had no impact to the reported consolidated balance sheets, consolidated statements of operations or net loss per share.
For the year ended December 31, 2020, this immaterial adjustment had the effect of increasing net cash used in operating activities and decreasing net cash used in investing activities by $1.2 million from what was previously reported.
Use of Estimates
Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ materially from those estimates. Significant areas requiring management’s estimates and assumptions include valuation allowance on deferred tax assets, determining the fair value of stock-based compensation and stock-based transactions, the fair value of the components of the warrant liabilities and accrued liabilities.
Cash, Cash Equivalents, Restricted Cash and Credit Risk
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash, cash equivalents and restricted cash at December 31, 2021 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities.
The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 250,000 . As of December 31, 2021, approximately $ 3.2 million in cash was uninsured based upon the FDIC insurance coverage limits.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows.
December 31,
December 31,
Cash, cash equivalents and restricted cash
2021
2020
Cash and cash equivalents
$
42,351,145
$
21,352,382
Restricted cash
$
1,146,186
$
—
Total cash, cash equivalents and restricted cash shown in statements of cash flows
$
43,497,331
$
21,352,382
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Cash received from grants in advance of incurring qualifying costs are recorded as restricted cash and deferred revenue until they are earned and recorded to grant income.
Property and Equipment
Leasehold improvements, furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from three to five years . Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.
Property and equipment - Construction in Progress
In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and install modular cleanrooms in a manufacturing facility. The facility's construction was completed during December 2020, and a certificate of occupancy was delivered to the Company in January 2021, and as such was placed into service in January 2021. All costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.
During the third and fourth quarters of 2021, and in connection with the Company's manufacturing facility in Houston, Texas, the Company incurred $ 2.2 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom. Such costs were recorded in fixed assets - construction in progress on the balance sheet as of December 31, 2021. Upon completion and installation of the modular cleanroom, all costs associated with the buildout will be recorded as manufacturing equipment and amortized over the estimated useful life.
Fair Value Measurements
The Company follows Accounting Standards Codification (“ASC”) 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the Company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows:
● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.
● Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, financial instruments and concentration of credit risk.
Patents and Patent Application Costs
Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred.
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Stock-Based Compensation
The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life:
Expected Term — The expected life of stock options was estimated using the "simplified method," as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant.
Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U. S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models. The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the awards. The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the period in which the related services are received as if the Company had paid cash for those services. Forfeitures are accounted for as incurred.
Research and Development Costs
Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses.
Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved.
Income Taxes
The Company follows the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets.
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Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of December 31, 2021 and 2020, no liability for unrecognized tax benefits was required to be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded during the years ended December 31, 2021 and 2020.
Grant Income
The Company recognizes grant income in accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the U. S. Department of Defense. In various situations, the Company receives certain payments from the Mayo Foundation for reimbursement of clinical supplies. These payments are non-refundable and are not dependent on the Company’s ongoing future performance. The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No. 2014 09, "Revenue from Contracts with Customers (Topic 606)" issued by FASB.
In August 2021, we received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support our Phase 2 clinical trial of MT-401.
In accordance with ASC 730-20-25-8, the extent the financial risk associated with the research and development has been transferred to CPRIT, because repayment of the grant depends solely on the results of research and development having future economic benefit, the Company accounts for this obligation as a contract to perform research and development for others. The funds received from CPRIT will initially be recorded as a deferred credit in the Company’s balance sheet.
Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. During the fourth quarter of 2021, the Company received $ 2.4 million advancement of funds in relation to the CPRIT grant. The Company recorded $ 1.2 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2021. At December 31, 2021, $ 1.1 million was recorded as restricted cash and deferred revenue on the Company's consolidated financial statements.
Loss per Common Share
Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities. Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation.
New Accounting Standards
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption.
Recent Accounting Standards Adopted in the Year
Income Taxes
In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company has adopted the new standard effective January 1, 2021 and has concluded that the adoption of this standard did not have a material impact on its consolidated financial statements and related disclosures.
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NOTE 4: NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
The following table sets forth the computation of net loss per share for the years ended December 31, 2021 and 2020, respectively:
For the Years Ended
December 31,
2021
2020
Numerator:
Net loss
$
( 41,878,871 )
$
( 28,706,070 )
Denominator:
Weighted average common shares outstanding
76,505,675
47,039,862
Net loss per share:
Basic and diluted
$
( 0.55 )
$
( 0.61 )
The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
For the Years Ended
December 31,
2021
2020
Common stock options
7,686,000
6,002,000
Common stock purchase warrants
19,830,000
20,830,000
Potentially dilutive securities
27,516,000
26,832,000
NOTE 5: OTHER RECEIVABLE
Pursuant to the Company’s lease agreement for its manufacturing facility, the Company incurred and paid for the construction invoices directly for both the structural improvements of the facility and the building of the manufacturing modular cleanroom (i.e. leasehold improvements and manufacturing equipment). In accordance with the agreement, upon completion of the facility’s construction, the Company was owed up to $ 1.0 million as reimbursement, and as such a landlord receivable was recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances. During the fiscal year ended 2020, the Company recorded a $ 1.0 million receivable in its consolidated financial statements. The Company received the $ 1.0 million reimbursement in April 2021.
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NOTE 6: PROPERTY AND EQUIPMENT
Property and equipment consist of the following as of December 31, 2021 and 2020, respectively:
December 31,
December 31,
Estimated Useful Lives
2021
2020
Lab and manufacturing equipment
5 Years
$
7,851,000
$
2,360,000
Computers, equipment and software
3 - 5 Years
1,020,000
835,000
Office furniture
5 Years
793,000
678,000
Leasehold improvements
Lesser of lease term or estimated useful life
3,173,000
289,000
Total
12,837,000
4,162,000
Less: accumulated depreciation
( 2,740,000 )
( 591,000 )
Construction in progress
2,226,000
6,789,000
Total fixed assets, net
$
12,323,000
$
10,360,000
Depreciation expense for the years ended December 31, 2021 and 2020 was approximately $ 2.1 million and $ 0.5 million, respectively.
In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.The Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in the manufacturing facility. $ 6.8 million is recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2020. The completion of the facility’s construction occurred during December 2020 and the Company received its certificate of occupancy in January 2021, and as such was placed into service in January 2021. During January 2021, all costs associated with the buildout will be recorded as either manufacturing equipment and/or leasehold improvements and amortized over the estimated useful life of the asset and/or leasehold lease.
During the year ended December 31, 2021, and in connection with the opening of the Company’s manufacturing facility in Houston, Texas, the Company incurred $ 2.2 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom. Such costs were recorded in fixed assets – construction in progress on the balance sheet as of December 31, 2021.
NOTE 7: LEASES
The Company leases manufacturing, research and administrative facilities under operating leases. The Company evaluates its contracts to determine if an arrangement is a lease at inception and classify it as a finance or operating lease. Currently, all of the Company’s leases are classified as operating leases. Leased assets and corresponding liabilities are recognized based on the present value of the lease payments over the lease term. The lease terms may include options to extend when it is reasonably certain that the Company will exercise that option. The company did not consider that option in calculating Right-of-use assets and lease liability as the Company is not reasonably certain it will extend the contract beyond the current terms.
Topic ASC 842 requires the Company to recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. Right-of-use assets are recorded in non-current assets on the Company’s consolidated balance sheets. Current and non-current lease liabilities are recorded within current liabilities and non-current liabilities, respectively, on its consolidated balance sheets. Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease.
As of December 31, 2021, the Company had total operating lease liabilities of approximately $ 11.9 million and right-of-use assets of approximately $ 9.8 million, which were included in the consolidated balance sheet.
Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Variable
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expenses generally represent the Company’s share of the landlord’s operating expenses. The Company does not act as a lessor or have any leases classified as financing leases.
The following summarizes quantitative information about the Company’s operating leases:
For the Years Ended
December 31,
2021
2020
Operating lease expense summary:
Operating lease expense
$
1,702,000
$
960,000
Short-term lease expense
—
22,000
Variable lease expense
606,000
167,000
Total
$
2,308,000
$
1,149,000
For the Years Ended
December 31,
2021
2020
Other information:
Operating cash flows - operating leases
$
1,077,000
$
544,000
The weighted-average remaining lease term as of December 31, 2021 and December 31, 2020 was approximately 8.4 years and 9.3 years, respectively. The weighted-average discount rate used to determine the operating lease liability as of December 31, 2021 and December 31, 2020 was approximately 5.7 %.
Maturities of the Company’s operating leases, excluding short-term leases, are as follows:
Year ended December 31, 2022
$
1,278,000
Year ended December 31, 2023
1,542,000
Year ended December 31, 2024
1,826,000
Year ended December 31, 2025
1,874,000
Year ended December 31, 2026
1,775,000
Thereafter
6,997,000
Total
15,292,000
Less present value discount
( 3,424,000 )
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at December 31, 2021
$
11,868,000
NOTE 8: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable and accrued liabilities consist of the following as of December 31, 2021 and 2020, respectively:
December 31,
December 31,
2021
2020
Accounts payable
$
5,144,000
$
2,935,000
Compensation and benefits
2,055,000
1,694,000
Process development expenses
385,000
277,000
Professional fees
644,000
875,000
Technology license fees
250,000
105,000
Arbitration settlement fees
2,407,000
—
Other
250,000
127,000
Total accounts payable and accrued liabilities
$
11,135,000
$
6,013,000
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NOTE 9: STOCKHOLDERS’ EQUITY
Preferred Stock
The Company has authorized up to 5,000,000 shares of preferred stock, $ 0.001 par value per share, for issuance. The preferred stock will have such rights, privileges and restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance. To date, the Company has not issued any preferred shares.
Common Stock
The Company has authorized up to 150,000,000 shares of common stock, $ 0.001 par value per share, for issuance. Significant 2021 and 2020 common stock transactions were as follows:
2021 Common Stock Transactions
Exercise of Stock Options
During the year ended December 31, 2021, certain outstanding options were exercised for 1,456 shares of common stock providing aggregate proceeds to the Company of approximately $ 3,100 .
Board Compensation
During the year ended December 31, 2021, the Company issued an aggregate of 0.1 million shares of common stock to its non-employee directors. The fair value of the common stock of approximately $ 0.2 million was recognized as a component of stock-based compensation expense in general and administrative expenses.
Underwritten Public Offering
On March 11, 2021, the Company entered into an underwriting agreement with Piper Sandler & Co., as representative of the several underwriters, to issue and sell 28,572,000 shares of common stock of the Company in an underwritten public offering. The offering price to the public was $ 1.75 per share. In addition, the Company granted the underwriters an option to purchase, for a period of 30 days , up to an additional 4,285,800 shares of common stock, which such option was partially exercised with respect to 3,710,857 shares. An aggregate of 32,282,857 shares of the Company’s common stock was issued for net proceeds of $ 52.6 million.
2020 Common Stock Transactions
Exercise of Stock Warrants
During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $ 0.6 million.
Board Compensation
During the year ended December 31, 2020, the Company issued an aggregate of 0.1 million shares of common stock to its non-employee directors. The fair value of the common stock of approximately $ 0.2 million was recognized as a component of stock-based compensation expense in general and administrative expenses.
Aspire Capital
On February 28, 2020, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $ 30.0 million of shares of the Company’s common stock over the 30-month term of the purchase agreement. In consideration for entering into the purchase agreement, the Company issued to Aspire Capital 0.3 million
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shares of the Company’s common stock as a commitment fee. The Company recorded the commitment fee to additional paid in capital. As of December 31, 2020, Aspire Capital had purchased 4.1 million shares under the Purchase Agreement, providing aggregate proceeds to the Company of approximately $ 6.2 million. Aspire Capital did not purchase any shares under the Purchase Agreement during the year ended December 31, 2021.
NOTE 10: WARRANTS
Share Purchase Warrants
A summary of the Company’s share purchase warrants as of December 31, 2021 and 2020, respectively, and changes during the period is presented below:
Weighted Average
Number of
Weighted Average
Remaining Contractual
Total Intrinsic
Warrants
Exercise Price
Life (in years)
Value
Balance - January 1, 2020
22,664,000
$
4.71
3.33
$
954,000
Exercised for cash
( 458,000 )
1.20
—
—
Expired or cancelled
( 1,376,000 )
9.46
—
—
Balance - December 31, 2020
20,830,000
4.47
2.60
—
Expired or cancelled
( 1,000,000 )
5.50
—
—
Balance - December 31, 2021
19,830,000
$
4.42
1.70
$
—
2020 Warrant Transactions
Exercise of Stock Warrants
During the year ended December 31, 2020, certain outstanding warrants were exercised for 0.5 million shares of common stock providing aggregate proceeds to the Company of approximately $ 0.6 million.
NOTE 11: STOCK OPTION PLANS
Options to Purchase Shares of Common Stock
2021 Equity Incentive Awards
On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan ("2020 Plan") which replaced the 2014 Omnibus Stock Option Plan. The 2020 Plan allows for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company. Awards under the 2020 Plan may be at prices and for terms as determined by the Company's board of directors and may have vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the stock on the grant date. Once granted, the exercise price of an option may not be reduced without the approval of the Company's stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules and regulations of the Nasdaq Stock Exchange.
Options granted under the 2020 Plan have a maximum term of ten years from the date of grant and generally vest over four years .
On February 10, 2021, pursuant to the Company's 2020 Equity Incentive Plan, the compensation committee of the Company's board of directors approved a total of 740,000 options to purchase the Company's common stock as equity-based incentive awards to the Company's executive officers, other than the Chief Executive Officer. Each option award was granted with an exercise price of $ 3.29 per share, the closing price of the Company's common stock on the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such executive officer's continued service on the applicable vesting date. Additionally, on February 10, 2021, the compensation committee of the Company's board of directors approved a total of 260,000 options to purchase the Company's common stock to non-executive employees of the Company as equity-based incentive awards. Each option award was granted with an exercise price of $ 3.29 per share, the closing price of the Company's common stock on
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the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee's continued service on the applicable vesting date.
On February 11, 2021, upon the recommendation of the compensation committee and pursuant to the Company's 2020 Equity Incentive Plan, the Company's board of directors approved a total of 430,000 options to purchase the Company's common stock as (equity-based incentive awards to the Company's Chief Executive Officer. The option award was granted with an exercise price of $ 3.06 per share, the closing price of the Company's common stock on the Nasdaq Global Market on February 11, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such Chief Executive Officer's continued service on the applicable vesting date.
The above awards were in addition to 90,000 stock option awards issued during the three months ended March 31, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 1.47 per share, the closing price of the Company's common stock on the Nasdaq Global Market on January 4, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date.
100,000 stock option awards were issued during the three months ended June 30, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 2.19 per share, the closing price of the Company's common stock on the Nasdaq Global Market on April 1, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date.
130,000 stock option awards were issued during the three months ended September 30, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 2.88 per share, the closing price of the Company's common stock on the Nasdaq Global Market on July 1, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date.
40,000 stock option awards were issued during the three months ended December 31, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 1.67 per share, the closing price of the Company's common stock on the Nasdaq Global Market on October 1, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date. Also, 125,000 stock option awards were issued to a new outside director. The option award was granted with an exercise price of $ 1.20 per share, the closing price of the Company's common stock on the Nasdaq Global Market on December 8, 2021, vesting in 36 equal monthly installments.
During the year ended December 31, 2021, 1,456 stock options were exercised for net proceeds of $ 3,100 .
As of December 31, 2021, approximately 2.9 million options are available to be issued from the 2020 Plan.
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Stock Options
A summary of the Company’s stock option activity is as follows for stock options:
Weighted Average
Remaining
Weighted Average
Total Intrinsic
Contractual
Number of Shares
Exercise Price
Value
Life (in years)
Outstanding as of January 1, 2021
6,001,814
$
6.22
$
—
8.3
Granted
1,915,000
2.90
—
8.9
Exercised
( 1,456 )
2.12
—
—
Canceled/Expired
( 229,125 )
3.59
—
—
Outstanding as of December 31, 2021
7,686,233
$
5.47
$
—
7.7
Options vested and exercisable
4,298,747
$
6.66
$
—
7.2
The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the years ended December 31, 2021 and 2020, respectively, were as follows:
For the Years Ended
December 31,
2021
2020
Exercise price
$
2.90
$
2.08
Expected term (years)
6.0
6.0
Expected stock price volatility
94
%
108
%
Risk-free rate of interest
1
%
1
%
Expected dividend rate
0
%
0
%
The following table sets forth stock-based compensation expenses recorded during the respective periods:
For the Years Ended
December 31,
2021
2020
Stock Compensation expenses:
Research and development
$
2,856,000
$
2,588,000
General and administrative
3,108,000
2,640,000
Total stock compensation expenses
$
5,964,000
$
5,228,000
At December 31, 2021, the total stock-based compensation cost related to unvested awards not yet recognized was $ 8.6 million. The expected weighted average period compensation costs to be recognized was 2.0 years. Future option grants will impact the compensation expense recognized.
NOTE 12: GRANT INCOME
During the years ended December 31, 2021 and 2020, the Company received $ 0 and $ 0.5 million, respectively, of a grant awarded to Mayo Foundation from the U.S. Department of Defense for the Phase 2 Clinical Trial of TPIV200. The grant compensated the Company for clinical supplies manufactured and provided by the Company for the clinical study.
Additionally, in August 2021, the Company received notice of a Product Development Research award totaling approximately $ 13.1 million from CPRIT to support the Company's Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the Company's Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group.
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During the fourth quarter of 2021, the Company received $ 2.4 million advancement of funds in relation to the CPRIT grant. The Company recorded $ 1.2 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2021. At December 31, 2021 $ 1.1 million was recorded as Restricted Cash and Deferred Revenue on the Company's consolidated financial statements.
NOTE 13: LEGAL PROCEEDINGS
From time to time, the Company may be party to ordinary, routine litigation incidental to their business. Other than below, the Company knows of no material, active or pending legal proceedings against the Company, nor is the Company involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to the Company’s interest.
An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc. (“FINRA”) by a broker seeking to be paid compensation for two financing transactions that occurred in 2018, a warrant conversion and a private placement brokered by another broker. The broker's claims were based on a placement agent agreement for a private placement it brokered in 2017, under which it alleged it was entitled to compensation for the 2018 transactions. The FINRA panel found in favor of the broker and awarded the broker $ 2.4 million for compensation, interest and attorney fees. As of September 30, 2021, the Company recorded an accrual of $ 2.4 million in accrued liabilities on its consolidated balance sheet and a $ 2.4 million charge to other expenses. On September 17, 2021, the broker filed a petition to confirm the FINRA arbitration award in the Supreme Court of New York for the County of New York. The Company removed the case to the United States District Court for the Southern District of New York on September 27, 2021. On October 22, 2021, the Company filed a motion in federal court to vacate the award.
On March 9, 2022, the Company was notified that its motion to vacate the award was denied and the broker was awarded an additional $ 0.1 million in interest. Post judgment interest will continue to accrue at 1.02 % until the judgement is paid.
NOTE 14: RELATED PARTY TRANSACTIONS
The following table sets forth related party transaction expenses recorded for the years ended December 31, 2021 and 2020, respectively.
For the Years Ended
December 31,
2021
2020
Baylor College of Medicine
$
2,851,000
$
1,818,000
Bio-Techne Corporation
306,000
152,000
Wilson Wolf Manufacturing Corporation
280,000
61,000
Total Research and development
$
3,437,000
$
2,031,000
$ 1.0 million of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2021.
Agreements with The Baylor College of Medicine (“BCM”) .
In November 2018, January 2020 and February 2020, the Company entered in Sponsored Research Agreements with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.
In September 2019, May 2020 and July 2021, the Company entered into Clinical Supply Agreements with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products.
In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities.
In August 2020, the Company entered in a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company investigator-initiated research studies.
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Purchases from Bio-Techne Corporation .
The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines. Mr. David Eansor is a member of the Company's board of directors and is serving as the President of the Protein Sciences Segment of Bio-Techne Corporation.
Purchases from Wilson Wolf Manufacturing Corporation .
The Company is currently utilizing Wilson Wolf Manufacturing Corporation for the purchases of cell culture devices called G-Rexes. Mr. John Wilson is a member of the Company's board of directors and is serving as the CEO of Wilson Wolf Manufacturing Corporation. Wilson Wolf Manufacturing became a related party during fiscal year 2021 and as such, $ 61,000 transactions for the period ended December 31, 2020 were included in the table above.
NOTE 15: INCOME TAXES
The Company has no income tax expense due to operating losses incurred for the years ended December 31, 2021 and 2020.
The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2021 and 2020 are as follows:
As of December 31,
2021
2020
2020
Deferred Tax Assets
(As revised)
(As reported)
Net Operating Loss Carryforward
29,087,000
21,783,000
21,783,000
Stock Compensation
5,599,000
4,718,000
6,775,000
Accrued Expenses
510,000
—
—
License Agreements
127,000
144,000
144,000
Research and Development
733,000
733,000
733,000
Charitable Contributions
8,000
8,000
8,000
Operating Lease Liability
2,514,000
2,626,000
2,626,000
38,578,000
30,012,000
32,069,000
Less: Valuation Allowance
( 36,401,000 )
( 27,632,000 )
( 29,689,000 )
Total Deferred Tax Assets
2,177,000
2,380,000
2,380,000
Deferred Tax Liabilities
Fixed Assets
( 94,000 )
( 57,000 )
—
Right-of-Use Assets
( 2,083,000 )
( 2,323,000 )
( 2,380,000 )
Total Deferred Tax Liabilities
( 2,177,000 )
( 2,380,000 )
( 2,380,000 )
Net Deferred Tax Assets/(Liabilities)
—
—
—
The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation allowance is established. Based upon the history of losses, management believes that it is more likely than not, that future benefits of deferred tax assets will not be realized and has established a full valuation allowance for the years ended December 31, 2021 and 2020. The Company decreased the prior period deferred tax asset by $ 2.1 million with a corresponding decrease in its valuation allowance. This immaterial adjustment mostly related to the correction of the cumulative value of cancelled non-qualified stock options. The Company has research and development tax credit carryforwards of $ 733,000 available to offset future federal income taxes. The research and development tax credit carryforwards begin to expire in 2030.
The Company has approximately $ 130.5 million of federal and $ 38.6 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $ 41.6 million, if not utilized, will expire between 2029 and 2037 . The federal net operating loss carryforwards of $ 88.9 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of
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$ 21.9 million, if not utilized, will begin to expire in 2035. The state net operating loss carryforwards of $ 16.7 million generated in 2018 and thereafter are subject to an 80 % limitation on taxable income, do not expire and will carry forward indefinitely.
In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s net operating loss carryforwards may be limited in the event of a change in ownership. A full Section 382 analysis has not been prepared and NOLs could be subject to limitation under Section 382.
The Company’s income tax returns for 2017 to 2020 are still open and subject to audit. In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years.
For the years ended December 31, 2021 and 2020, the expected tax expense (benefit) based on the U. S. federal statutory rate is reconciled with the actual tax provision (benefit) as follows:
For the Years Ended December 31,
2021
2020
Percent of
Percent of
Amount
Pretax Loss
Amount
Pretax Loss
U.S. federal statutory rate
( 8,795,000 )
21.00
%
( 6,028,000 )
21.00
%
State taxes, net of federal benefit
( 48,000 )
0.11
%
( 118,000 )
0.41
%
Tax rate change
( 291,000 )
0.69
%
677,000
- 2.36
%
Permanent Differences
0.00
%
- Change in fair value of derivative liabilities
—
0.00
%
( 7,000 )
0.02
%
- Other permanent differences
262,000
- 0.63
%
182,000
- 0.63
%
Change in valuation allowance
8,769,000
- 20.94
%
5,057,000
- 17.62
%
Deferred true-up
103,000
- 0.25
%
237,000
- 0.83
%
Income tax provision/(benefit)
—
0.00
%
—
0.00
%
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. As of December 31, 2020, and 2019, there were no unrecognized tax benefits. The Company recognizes accrued interest and penalties as income tax expense. No amounts were accrued for the payment of interest and penalties at December 31, 2021 and 2020. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position in the next year.
On March 27, 2020, the CARES Act was enabled in response to COVID-19 pandemic. Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted. The CARES Act made various tax law changes including among other things (i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional expensing of interest, (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k),(iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018, 2019 and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes and (iv) enhancing the recoverability of alternative minimum tax credits. Given the Company’s full valuation allowance position, the CARES Act did not have an impact on the financial statements.
NOTE 16: SUBSEQUENT EVENTS
On February 16, 2022, the Company received a notice from the Nasdaq Global Market that the Company was not in compliance with Nasdaq's Listing Rule 5450(a)(1), as the minimum bid price of its common stock had been below $ 1.00 per share for 30 consecutive business days. The Company has 180 calendar days, or until August 15, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company's common stock must meet or exceed $ 1.00 per share for a minimum of ten consecutive business days during this 180 -calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by August 15, 2022, the Company may be eligible for an additional 180 -calendar day compliance period if it elects to transfer to the Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.