Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2023

☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____.

Commission File Number: 001-37939

MARKER THERAPEUTICS, INC.

(Name of registrant in its charter)


DELAWARE		45-4497941
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)



9350 Kirby Drive, Suite 300 Houston, Texas		77054
(Address of principal executive offices)		(Zip Code)

(713) 400-6400
(Issuer’s telephone number)

4551 Kennedy Commerce Drive, Houston, Texas, 77032

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	MRKR	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “accelerated filer”, “large accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 8, 2023, the Company had 8,809,260 shares of common stock issued and outstanding.

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		Page

PART I – FINANCIAL INFORMATION		1

Item 1.	Financial Statements (Unaudited)	1

	Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022	1

	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2023 and 2022	2

	Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022	3

	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022	4

	Notes to Condensed Consolidated Financial Statements	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	16

Item 3.	Quantitative and Qualitative Disclosures About Market Risk.	24

Item 4.	Controls and Procedures.	24

PART II – OTHER INFORMATION		25

Item 1.	Legal Proceedings.	25

Item 1A.	Risk Factors.	25

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds.	26

Item 3.	Defaults Upon Senior Securities.	26

Item 4.	Mine Safety Disclosure.	26

Item 5.	Other Information.	27

Item 6.	Exhibits.	27

Signatures		29

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)


	June 30,		December 31,
	2023		2022
ASSETS
Current assets:
Cash and cash equivalents	$	18,122,086	$	11,782,172
Prepaid expenses and deposits		2,087,462		1,849,239
Other receivables		1,746,100		2,402,004
Current assets of discontinued operations		—		585,840
Total current assets		21,955,648		16,619,255
Non-current assets of discontinued operations		—		17,802,929
Total assets	$	21,955,648	$	34,422,184

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities	$	2,660,616	$	2,521,193
Current liabilities of discontinued operations		260,280		5,260,616
Total current liabilities		2,920,896		7,781,809
Non-current liabilities of discontinued operations		—		7,039,338
Total liabilities		2,920,896		14,821,147

Stockholders’ equity:
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively		—		—
Common stock, $0.001 par value, 30 million shares authorized, 8.8 million and 8.4 million shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively		8,799		8,406
Additional paid-in capital		449,526,789		447,641,680
Accumulated deficit		(430,500,836)		(428,049,049)
Total stockholders’ equity		19,034,752		19,601,037

Total liabilities and stockholders’ equity	$	21,955,648	$	34,422,184

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.

See accompanying notes to these unaudited condensed consolidated financial statements.

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MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Revenues:
Grant income	$	762,658	$	790,508	$	1,996,995	$	1,754,830
Total revenues		762,658		790,508		1,996,995		1,754,830
Operating expenses:
Research and development		2,377,993		2,923,877		5,754,492		6,194,241
General and administrative		2,518,725		3,135,168		4,686,044		6,486,465
Total operating expenses		4,896,718		6,059,045		10,440,536		12,680,706
Loss from operations		(4,134,060)		(5,268,537)		(8,443,541)		(10,925,876)
Other income (expenses):
Arbitration settlement		—		—		—		(118,880)
Interest income		35,080		35,786		119,734		38,902
Loss from continuing operations		(4,098,980)		(5,232,751)		(8,323,807)		(11,005,854)
Discontinued operations:
Loss from discontinued operations before income taxes		(2,179,657)		(4,011,437)		(2,922,406)		(8,148,842)
Gain on disposal of discontinued operations		8,794,426		—		8,794,426		—
Income (loss) from discontinued operations		6,614,769		(4,011,437)		5,872,020		(8,148,842)
Net income (loss)	$	2,515,789	$	(9,244,188)	$	(2,451,787)	$	(19,154,696)

Net earnings (loss) per share, basic and diluted:
Loss from continuing operations	$	(0.47)	$	(0.63)	$	(0.95)	$	(1.32)
Income (loss) from discontinued operations	$	0.75	$	(0.48)	$	0.67	$	(0.98)
Net earnings (loss) per share	$	0.29	$	(1.11)	$	(0.28)	$	(2.30)

Weighted average number of common shares outstanding,
Basic and diluted		8,798,956		8,359,205		8,760,209		8,335,119

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock. All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.

See accompanying notes to these unaudited condensed consolidated financial statements.

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MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)


	For the Three Months Ended June 30, 2023
								Total
	Common Stock			Additional Paid-		Accumulated		Stockholders’
	Shares	Par value		in Capital		Deficit		Equity
Balance at April 1, 2023	8,798,829	$	8,799	$	448,921,174	$	(433,016,625)	$	15,913,348
Issuance of common stock from exercise of stock options	344		—		736		—		736
Stock-based compensation	—		—		604,879		—		604,879
Net income	—		—		—		2,515,789		2,515,789
Balance at June 30, 2023	8,799,173		8,799		449,526,789		(430,500,836)		19,034,752


	For the Six Months Ended June 30, 2023
								Total
	Common Stock			Additional Paid-		Accumulated		Stockholders’
	Shares	Par value		in Capital		Deficit		Equity
Balance at January 1, 2023	8,405,771	$	8,406	$	447,641,680	$	(428,049,049)	$	19,601,037
Issuance of common stock for cash	212,761		213		619,761		—		619,974
Issuance of common stock as commitment fee for future financing	180,410		180		(180)		—		—
Issuance of common stock from exercise of stock options	344		—		736		—		736
Stock-based compensation	—		—		1,264,792		—		1,264,792
Net loss	—		—		—		(2,451,787)		(2,451,787)
Fractional shares adjustment due to reverse split	(113)		—		—		—		—
Balance at June 30, 2023	8,799,173		8,799		449,526,789		(430,500,836)		19,034,752


	For the Three Months Ended June 30, 2022
								Total
	Common Stock			Additional Paid-		Accumulated		Stockholders’
	Shares	Par value		in Capital		Deficit		Equity
Balance at April 1, 2022	8,345,119	$	8,345	$	443,726,282	$	(408,028,863)	$	35,705,764
Issuance common shares for cash, net	14,800		15		63,558		—		63,573
Stock-based compensation	—		—		1,501,124		—		1,501,124
Net loss	—		—		—		(9,244,188)		(9,244,188)
Balance at June 30, 2022	8,359,919	$	8,360	$	445,290,964	$	(417,273,051)	$	28,026,273


	For the Six Months Ended June 30, 2022
								Total
	Common Stock			Additional Paid-		Accumulated		Stockholders’
	Shares	Par value		in Capital		Deficit		Equity
Balance at January 1, 2022	8,307,868	$	8,308	$	442,095,642	$	(398,118,355)	$	43,985,595
Issuance common shares for cash, net	14,800		15		63,558		—		63,573
Stock-based compensation	37,251		37		3,131,764		—		3,131,801
Net loss	—		—		—		(19,154,696)		(19,154,696)
Balance at June 30, 2022	8,359,919	$	8,360	$	445,290,964	$	(417,273,051)	$	28,026,273

See accompanying notes to these unaudited condensed consolidated financial statements.

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MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)


	For the Six Months Ended
	June 30,
	2023		2022
Cash Flows from Operating Activities:
Net loss	$	(2,451,787)	$	(19,154,696)
Less: gain (loss) from discontinued operations, net of tax		5,872,020		(8,148,842)
Net loss from continuing operations		(8,323,807)		(11,005,854)
Reconciliation of net loss to net cash used in operating activities:
Stock-based compensation		539,858		1,986,402
Changes in operating assets and liabilities:
Prepaid expenses and deposits		(238,223)		(309,254)
Other receivables		655,904		(627,392)
Accounts payable and accrued expenses		197,030		(1,061,562)
Deferred revenue		—		(1,146,186)
Net cash used in operating activities - continuing operations		(7,169,238)		(12,163,846)
Net cash used in operating activities - discontinued operations		(5,775,680)		(856,922)
Net cash used in operating activities		(12,944,918)		(13,020,768)
Cash Flows from Investing Activities:
Net cash provided by (used in) investing activities - discontinued operations		18,664,122		(4,718,428)
Net cash provided by (used in) investing activities		18,664,122		(4,718,428)
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net		619,974		63,573
Proceeds from stock options exercise		736		—
Net cash provided by financing activities		620,710		63,573
Net increase (decrease) in cash, cash equivalents and restricted cash (1)		6,339,914		(17,675,623)

Cash, cash equivalents and restricted cash at beginning of the period (1)		11,782,172		43,497,331
Cash and cash equivalents at end of the period	$	18,122,086	$	25,821,708

(1) As of June 30, 2022 and December 31, 2021, the Company had $0 and $1,146,186 of restricted cash, respectively.


	For the Six Months Ended
	June 30,
	2023		2022
Supplemental schedule of non-cash financing and investing activities:
Changes between assets and liabilities in discontinued operations	$	141,979	$	25,025
Issuance of common stock as commitment fee for future financing	$	180	$	—

See accompanying notes to these unaudited condensed consolidated financial statements.

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MARKER THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(Unaudited)

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 for the treatment of hematological malignancies and solid tumor indications. The Company’s multiTAA 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.

Purchase Agreement With Cell Ready

On June 26, 2023, the Company completed the previously announced transaction with Cell Ready, LLC (“Cell Ready”) pursuant to a Purchase Agreement (the “Cell Ready Purchase Agreement), dated May 1, 2023, by and between the Company and Cell Ready. Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, therefore Cell Ready is a related party. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, the Company (i) assigned to Cell Ready the leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready its rights, title and interest in the Company's Master Services Agreement for Product Supply (the “MSA”), dated April 7, 2023, by and between the Company, Cell Ready and Indapta Therapeutics, Inc., as well as its rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively, the “Purchased Assets”). Following the Closing Date, the Company and Cell Ready have agreed to enter into a long-term contract pursuant to which Cell Ready will perform a wide variety of services for the Company, including research and development, manufacturing, and regulatory activity in support of the Company’s clinical trials; however, the parties have not yet executed such agreement. Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of the Company’s former employees in its manufacturing, development, quality and regulatory affairs functions.

The Purchased Assets constituted a significant disposition. Based upon the magnitude of the disposition and because the Company is exiting certain manufacturing operations, the disposition represents a significant strategic shift that will have a material effect on the Company’s operations and financial results. Accordingly, the assets sold meet the definition of a discontinued operation, as defined by Accounting Standards Codification 205-20 – Discontinued Operations, and prior comparative periods have been retrospectively adjusted to reflect the current presentation.

Reverse Stock Split

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock (the “Reverse Stock Split”) and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All references to common stock, warrants to purchase common stock, options to purchase common stock, share data, per share data and related information contained in the condensed consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Payment for fractional shares resulting from the reverse stock split amounted to $394.80.

Organizational Restructuring

In May 2023 and June 2023, the Company implemented changes to its organizational structure as part of an operational cost reduction plan and reorganization plan due to the transaction with Cell Ready. In connection with these changes, the Company reduced headcount, including the separation of its former Chief Executive Officer, Peter Hoang, in May 2023 and its former Chief Accounting Officer, Michael Loiacono in June 2023. During the second quarter of 2023, the Company recorded $0.9 million of severance and termination-related costs. The payments of these costs were completed in July of 2023.

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Effective May 1, 2023, the Company’s board of directors appointed Dr. Vera as the Company’s Chief Executive Officer.

Effective June 30, 2023, the board of directors appointed Eliot M. Lurier as the Company’s Interim Chief Financial Officer. Mr. Lurier provides consulting services to the Company pursuant to a consulting agreement between the Company and Danforth Advisors, LLC and receives no compensation directly from the Company.

NOTE 2: BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results (see Note 6 for information on discontinued operations).

The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at June 30, 2023 has been derived from unaudited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s annual report on Form 10-K filed on March 22, 2023.

NOTE 3: LIQUIDITY AND FINANCIAL CONDITION

As of June 30, 2023, the Company had cash and cash equivalents of approximately $18.1 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.

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 shelf registration statement on Form S-3 includes a prospectus supplement covering the offering up to $9.87 million of shares of common stock over the 12 months ending March 22, 2024 pursuant to General Instruction I.B.6 of Form S-3, which limits the amounts that the Company may sell under the registration statement, and in accordance with the ATM agreement. 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. During the six months ended June 30, 2023, the Company sold 200,261 shares of its common stock under the ATM Agreement for proceeds of $0.6 million.

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 its lead multiTAA-specific T cell product 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 $6.9 million of funds from the CPRIT grant. The Company recorded $0.7 million and $1.8 million of grant income related to the CPRIT grant as revenue for the three and six months ended June 30, 2023, respectively.

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In September 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that it had awarded the Company a $2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. The Company recorded $0.1 million and $0.2 million of grant income related to the FDA grant as revenue for the three and six months ended June 30, 2023, respectively.

In December 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $25,000,000 of shares of its common stock (“the Purchase Shares”) from time to time over a 24-month term, at a variable price with certain market-based terms as defined in the Purchase Agreement. The Purchase Agreement does not exhibit any of the characteristics for liability classification under ASC Topic 480, Distinguishing Liabilities from Equity. Instead, the purchase agreement is indexed to the Company’s own stock under ASC Subtopic 815-40, Contracts in Entity’s Own Equity, and classified as equity. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. During the three months ended March 31, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately $33,000.

In March 2023, the Company signed an agreement with AlloVir, Inc. (“Allovir”) in which Marker will provide services for AlloVirs’ long range process development and scale optimization. Under the terms of this agreement, Marker would have received total compensation in the amount of $0.4 million, estimated to have been fully earned by September 30, 2023. As of June 30, 2023, the Company did not receive any funds from the Allovir agreement. Additionally, the Allovir agreement was included as part of the Purchased Asset under the Cell Ready Agreement (defined below) and future compensation under the AlloVir agreement will be paid to Cell Ready.

As described in Note 1, on June 26, 2023, the Company completed the previously announced transaction with Cell Ready pursuant to the Cell Ready Purchase Agreement. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, the Company (i) assigned to Cell Ready the leases for the Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready its rights, title and interest in the Company’s MSA, dated April 7, 2023, by and between the Company, Cell Ready and Indapta Therapeutics, Inc., as well as its rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively, the “Purchased Assets”). Following the Closing Date, the Company and Cell Ready have agreed to enter into a long-term contract pursuant to which Cell Ready will perform a wide variety of services for the Company, including research and development, manufacturing, and regulatory activity in support of the Company’s clinical trials; however, the parties have not yet executed such agreement. Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of the Company’s former employees in its manufacturing, development, quality and regulatory affairs functions.

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 and cash equivalents as of June 30, 2023 will enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025. Prior to the Cell Ready transaction, there was substantial doubt regarding the Company’s ability to continue as a going concern, which was alleviated by the proceeds from the transaction.

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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;

●	enters into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical manufacturing supply;

●	establishes sales, marketing and distribution infrastructure and establishes third-party 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.

The Company has no sources of revenue to provide incoming cash flows to sustain its future operations. As outlined above, its ability to pursue its long-term planned business activities is dependent upon its successful efforts to raise additional capital and grant income.

The COVID-19 pandemic, decades-high inflation and concerns about an economic recession in the United States or other major markets has resulted in, among other things, volatility in the capital markets that may have the effect of 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 due to these factors could materially affect the Company’s business and the value of its common stock.

NOTE 4: SIGNIFICANT ACCOUNTING POLICIES

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 (see Note 6 for information on discontinued operations).

Discontinued Operations

The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its operations and financial results. Therefore, the Purchased Assets, related party revenue, service revenue and related expenses are classified as discontinued operations for all periods presented herein. See Note 6 for further information.

Modification of Stock Options

During the three and six months ended June 30, 2023, the Company recorded incremental stock-based compensation expense of $0.2 million pertaining to the modification of stock options in connection with the termination of certain employees, including individuals that were hired by Cell Ready. The modification provided for an acceleration of unvested options, resulting in $0.2 million in compensation expense that was immediately recognized, and is reflected in loss from discontinued operations.

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New Accounting Standards

From time to time, new accounting pronouncements are issued by Financial Accounting Standards Board (“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 consolidated financial position or results of operations upon adoption.

There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2022 filed on March 22, 2023.

NOTE 5: NET LOSS PER SHARE

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 three and six months ended June 30, 2023 and 2022, respectively:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Loss from continuing operations	$	(4,098,980)	$	(5,232,751)	$	(8,323,807)	$	(11,005,854)
Income (loss) from discontinued operations	$	6,614,769	$	(4,011,437)	$	5,872,020	$	(8,148,842)
Net income (loss)	$	2,515,789	$	(9,244,188)	$	(2,451,787)	$	(19,154,696)

Denominator:
Weighted average common shares outstanding, basic and diluted		8,798,956		8,359,205		8,760,209		8,335,119

Net loss per share, basic and diluted:
Loss from continuing operations	$	(0.47)	$	(0.63)	$	(0.95)	$	(1.32)
Income (loss) from discontinued operations	$	0.75	$	(0.48)	$	0.67	$	(0.98)
Net income (loss)	$	0.29	$	(1.11)	$	(0.28)	$	(2.30)

The following securities, rounded to the nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:


	For the Three and Six Months Ended
	June 30,
	2023	2022
Common stock options	1,143,000	995,900
Common stock purchase warrants	1,848,000	1,848,200
Potentially dilutive securities	2,991,000	2,844,100

All common stock options and common stock purchase warrants outstanding as of June 30, 2023 were out of the money and were not included in net loss per share calculation.

NOTE 6: DISCONTINUED OPERATIONS

As discussed in Note 1, on June 26, 2023, the Company completed the previously announced transaction with Cell Ready for cash consideration of $19.0 million, resulting in derecognition of the Purchased Assets and a gain on sale of approximately $8.8 million.

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The assets and liabilities classified in discontinued operations as of June 30, 2023 and December 31, 2022 are as follows:


	June 30, 2023		December 31, 2022
Prepaid expenses and other current assets	$	—	$	585,840
Total current assets of discontinued operations				585,840
Fixed Assets		—		12,323,143
Right of use assets		—		5,479,786
Total non-current assets of discontinued operations				17,802,929
Total assets of discontinued operations	$	—	$	18,388,769

Accounts payable	$	260,280	$	2,183,418
Related party deferred revenue		—		2,500,000
Short-term lease liabilities		—		577,198
Total current liabilities of discontinued operations		260,280		5,260,616
Long-term lease liabilities		—		7,039,338
Total non-current liabilities of discontinued operations		—		7,039,338
Total liabilities of discontinued operations	$	260,280	$	12,299,954

The Company reclassified the following operations to discontinued operations for the three and six months ended June 30, 2023 and 2022, respectively, excluding the gain on disposal:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Revenues:
Service revenue	$	816,641	$	—	$	816,641	$	—
Related party service revenue		—		—		3,500,000		—
Total revenues		816,641		—		4,316,641		—
Operating expenses:
Research and development		2,667,712		3,631,422		6,561,957		7,387,124
General and administrative		328,585		380,015		677,090		761,719
Total operating expenses		2,996,297		4,011,437		7,239,048		8,148,842
Loss from discontinued operations	$	(2,179,657)	$	(4,011,437)	$	(2,922,406)	$	(8,148,842)

Related Party Service Revenue

In April 2022, the Company entered into a binding services agreement ("Wilson Wolf Agreement") with Wilson Wolf Manufacturing Corporation (“Wilson Wolf”). Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf. Wilson Wolf is in the business of creating products and services intended to simplify and expedite the transition of cell therapies and gene-modified cell therapies to mainstream society (the “Wilson Wolf Mission”). Pursuant to the Wilson Wolf Agreement, Wilson Wolf made a cash payment to the Company in the amount of $8.0 million, as consideration for certain training and research services.

For the three-month period ending March 31, 2023, the Company recognized the final $2.5 million of revenue pursuant to this $8.0 million agreement and at June 30, 2023, the Company had no related party deferred revenue on its condensed consolidated balance sheet.

Additionally, pursuant to the Wilson Wolf Agreement, Wilson Wolf agreed to pay the Company an additional $1.0 million because the Work Direction was completed within one year from the onset of the Wilson Wolf Agreement, achieving the agreed milestone. As such, the Company recorded an additional $1.0 million of service fee revenue during the three months ended March 31, 2023, which was received in May 2023 and recorded to discontinued operations.

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Service Revenue

In April 2023, we signed the Indapta Master Services Agreement, pursuant to which the Company provided services to Indapta. Under an executed work order of that agreement, now complete, we recognized $0.8 million for the services rendered during the three and six months ended June 30, 2023. Effective as of the closing date of the Purchase Agreement with Cell Ready, the rights and obligations to the Indapta Agreement were transferred to Cell Ready, and as such the revenues were recorded to discontinued operations.

NOTE 7: PROPERTY AND EQUIPMENT

Substantially all of the previously reported property and equipment was disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.

NOTE 8: LEASES

Substantially all of the previously reported leases were disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.

NOTE 9: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

Accounts payable and accrued liabilities consist of the following as of June 30, 2023 and December 31, 2022, respectively:


	June 30,		December 31,
	2023		2022
Accounts payable	$	1,330,000	$	1,101,000
Compensation and benefits		610,000		750,000
Process development expenses		—		—
Professional fees		525,000		518,000
Arbitration settlement fees		—		114,000
Other		196,000		38,000
Total accounts payable and accrued liabilities	$	2,661,000	$	2,521,000

NOTE 10: STOCKHOLDERS’ EQUITY

Reverse Stock Split

On January 26, 2023, the Company effected the Reverse Stock Split and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All historical share and per share amounts reflected in this report have been adjusted to reflect the Reverse Stock Split.

Common Stock Transactions

Issuance of Stock Pursuant to ATM Agreement

During the six months ended June 30, 2023, the Company sold 200,261 shares of its common stock under the ATM Agreement for proceeds of $0.6 million.

Stock Purchase Agreement

In December 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $25,000,000 of shares of its common stock (the “Purchase Shares”) from time to time over

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a 24-month term, at a variable price with certain market-based terms as defined in the Purchase Agreement. The Purchase Agreement does not exhibit any of the characteristics for liability classification under ASC Topic 480, Distinguishing Liabilities from Equity. Instead, the purchase agreement is indexed to the Company’s own stock under ASC Subtopic 815-40, Contracts in Entity’s Own Equity, and classified as equity. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. During the six months ended June 30, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately $33,000.

Exercise of Stock Options

During the six months ended June 30, 2023, certain outstanding options were exercised for 344 shares of common stock, providing aggregate proceeds to the Company of approximately $700.

Share Purchase Warrants

A summary of the Company’s share purchase warrants as of June 30, 2023 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, 2023	1,848,000	$	44.51	0.79	$	—
Expired or cancelled	—		—	—		—
Balance - June 30, 2023	1,848,000	$	44.51	0.30	$	—

NOTE 11: STOCK-BASED COMPENSATION

Stock Options

2022 Equity Incentive Awards

On February 27, 2023, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 316,855 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers and management team. Each option award was granted with an exercise price of $2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, 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 27, 2023, the compensation committee of the Company’s board of directors approved a total of 87,677 options to purchase the Company’s common stock to non-executive employees and management team of the Company as equity-based incentive awards. Each option award was granted with an exercise price of $2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, 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.

The above awards were in addition to 7,000 stock option awards issued during the three months ended March 31, 2023 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $2.769 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2023, 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.

Additionally, 1,000 stock option awards issued during the three months ended June 30, 2023 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $0.7802 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on April 3, 2023, 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.

On May 10, 2023, the Company’s board of directors approved a one-time share option grant of 100,000 shares of common stock to Dr. Vera for his appointment as the Company’s Chief Executive Officer. The option has a term of ten years and will vest in equal annual

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installments on May 10, 2024, May 10, 2025, May 10, 2026 and May 10, 2027, subject to Mr. Vera’s continued service to the Company as of the applicable vesting date. Each option award was granted with an exercise price of $1.42 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on May 10, 2023.

Also, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s board of directors, a total of 32,000 stock option awards were issued during the three months ended June 30, 2023 to independent members of the board of directors of the Company. Each option award was granted with an exercise price of $1.72 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on June 6, 2023. Each option award will vest in one year subject to the director’s continuance of service through June 6, 2024.

A summary of the Company’s stock option activity for the three months ended June 30, 2023 is as follows:


						Weighted Average
						Remaining
		Weighted Average				Contractual
	Number of Shares	Exercise Price		Total Intrinsic Value		Life (in years)
Outstanding as of January 1, 2023	886,173	$	42.90	$	—	7.3
Granted	544,532		1.99		—	9.7
Exercised	(344)		2.14		—	—
Canceled/Expired	(287,803)		7.57		—	—
Outstanding as of June 30, 2023	1,142,558	$	32.30	$	455,000	6.9
Options vested and exercisable	687,689	$	50.53	$	26,000	5.3

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 six months ended June 30, 2023 was as follows:


	For the Six Months Ended
	June 30, 2023
Exercise price	$	1.99
Expected term (years)		6.0
Expected stock price volatility		91	%
Risk-free rate of interest		4	%
Expected dividend rate		0	%

The following table sets forth stock-based compensation expenses recorded during the respective periods:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Stock Compensation expenses:
Research and development	$	42,000	$	200,000	$	193,000	$	398,000
General and administrative		127,000		739,000		347,000		1,588,000
Stock compensation in continuing operations		169,000		939,000		540,000		1,986,000
Stock compensation in discontinued operations		437,000		563,000		725,000		1,146,000
Total stock compensation expenses	$	606,000	$	1,502,000	$	1,265,000	$	3,132,000

During the three and six months ended June 30, 2023, the Company recorded incremental stock-based compensation expense of approximately $0.2 million pertaining to the modification of stock options in connection with the termination of certain employees that were hired by Cell Ready. The modification provided for an acceleration of unvested options, resulting in a change in compensation expense that was immediately recognized. $0.2 million is reflected in loss from discontinued operations.

As of June 30, 2023, the total stock-based compensation cost related to unvested awards not yet recognized was $1.0 million. The expected weighted average period compensation costs to be recognized was approximately 1.9 years. Future option grants will impact the compensation expense recognized.

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NOTE 12: GRANT INCOME

CPRIT

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.

If restricted cash is received from grants in advance of incurring qualifying costs, it is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. There was no restricted cash recorded as of June 30, 2023 and as of December 31, 2022. If qualifying grant income is earned in advance of cash received from grants, it is recognized as revenue and recorded as other receivable.

The Company recorded $0.7 million and $1.8 million of grant income related to the CPRIT grant as revenue for the three and six months ended June 30, 2023, respectively. At June 30, 2023, the Company recorded $1.7 million of grant income receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT. In July 2023, the Company received $2.1 million from CPRIT.

FDA

In September 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. The Company recorded $0.1 million and $0.2 million of grant income related to the FDA grant as revenue for the three and six months ended June 30, 2023, respectively.

NOTE 13: LEGAL PROCEEDINGS

From time to time, the Company may be party to ordinary, routine litigation incidental to their business. 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. The Company is not currently a party to any material legal proceedings, and the Company is not aware of any pending or threatened legal proceeding against it that it believes could have an adverse effect on its business, operating results or financial condition.

NOTE 14: RELATED PARTY EXPENSES

The following table sets forth related party transaction expenses recorded for the three and six months ended June 30, 2023 and 2022, respectively.


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Baylor College of Medicine	$	2,000	$	285,000	$	13,000	$	1,142,000
Bio-Techne Corporation		—		—		—		101,000
Wilson Wolf Manufacturing Corporation		73,000		46,000		277,000		101,000
Total Research and development	$	75,000	$	331,000	$	290,000	$	1,344,000

No related party transactions are included in accounts payable and accrued liabilities as of June 30, 2023.

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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.

The Company has also entered into a Clinical Site Agreement with BCM, which provided for BCM to conduct clinical trials for the Company and is a part of continuing operations.

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 was serving as the President of the Protein Sciences Segment of Bio-Techne Corporation. Mr. Eansor resigned from Bio-Techne Corporation on March 1, 2022, and as such, two months of transactions in 2022 are included in the table above.

Purchases from Wilson Wolf.

The Company is currently utilizing Wilson Wolf 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.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. All statements other than statements relating to historical matters including statements to the effect that we “believe”, “expect”, “anticipate”, “plan”, “target”, “intend” and similar expressions should be considered forward-looking statements. Our actual results could differ materially from those discussed in the forward-looking statements as a result of a number of important factors, including factors discussed in this section and elsewhere in this Quarterly Report on Form 10-Q, and the risks discussed in our other filings with the SEC. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its potential impact on our business and the global economy. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis, judgment, belief or expectation only as the date hereof. We assume no obligation to update these forward-looking statements to reflect events or circumstance that arise after the date hereof.

As used in this quarterly report: (i) the terms “we”, “us”, “our”, “Marker” and the “Company” mean Marker Therapeutics, Inc. and its wholly owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. which wholly owns GeneMax Pharmaceuticals Canada Inc., unless the context otherwise requires; (ii) “SEC” refers to the Securities and Exchange Commission; (iii) “Securities Act” refers to the Securities Act of 1933, as amended; (iv) “Exchange Act” refers to the Securities Exchange Act of 1934, as amended; and (v) all dollar amounts refer to United States dollars unless otherwise indicated.

The following should be read in conjunction with our unaudited condensed consolidated interim financial statements and related notes included in this Quarterly Report on Form 10-Q.

Company Overview

We are a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. We developed our lead product candidates from our multiTAA-specific T cell technology, which is based on the manufacture of non-engineered, tumor-specific T cells that recognize multiple tumor-associated antigens, or TAAs. multiTAA-specific T cells are able to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. When infused into a cancer patient, the multiTAA-specific T cells are designed to kill cancer cells expressing the TAA targets and potentially recruit the patient’s immune system to participate in the cancer killing process.

We licensed the underlying technology for multiTAA-specific T cell therapy from Baylor College of Medicine, or BCM, in March 2018. BCM had utilized the therapy in seven exploratory clinical trials. In these studies, BCM treated over 180 patients suffering from a variety of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, acute lymphoblastic leukemia and pancreatic cancer. In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, epitope spreading, and decreased toxicity compared to other cellular therapies.

We are advancing three product candidates as part of our multiTAA-specific T cell program for:

autologous treatment of lymphoma, and selected solid tumors

allogeneic T cells for the treatment of acute myeloid leukemia, or AML

off-the-shelf products in various indications

Our current clinical development programs are:

●

MT-401 for the treatment of post-transplant AML

●

MT-401-OTS for the treatment of AML

●

MT-601 for the treatment of lymphoma

●

MT-601 for the treatment of pancreatic cancer¹

¹ Clinical advancement will be pending additional financial support from non-dilutive grant activities.

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We are currently undertaking a strategic review of our clinical development programs, including with respect to clinical trial initiation and readout guidance, and look forward to providing an update once completed.

We believe that the simplicity of our manufacturing process allows additional modifications to expand multiTAA-specific T cell recognition of cancer targets. In May 2023, we entered into a purchase agreement with Cell Ready, LLC with respect to our manufacturing facility and certain related assets. See “—Recent Developments.”

Pipeline

Our clinical-stage pipeline, including clinical trials being conducted by BCM and other partners, is set forth below:

Recent Developments

On June 26, 2023, we completed the previously announced transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell Ready Purchase Agreement, dated May 1, 2023, by and between us and Cell Ready. Mr. John Wilson is a member of our board of directors and is serving as the CEO of Cell Ready, therefore Cell Ready is a related party. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, we (i) assigned to Cell Ready the leases for our two manufacturing facilities in Houston, Texas, or the Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready our rights, title and interest in our Master Services Agreement for Product Supply, or the MSA, dated April 7, 2023, by and between us, Cell Ready and Indapta Therapeutics, Inc., or Indapta, as well as our rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively referred to as the “Purchased Assets”). Following the Closing Date, we and Cell Ready have agreed to enter into a long-term contract with pursuant to which Cell Ready will perform a wide variety of services for us, including research and development, manufacturing, and regulatory activity in support of our clinical trials; however, the parties have not yet executed such agreement. Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of our former employees in our manufacturing, development, quality and regulatory affairs functions.

In May 2023, we announced that we had received a $2.0 million grant from the National Institutes of Health Small Business Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents.

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Organizational Restructuring

In May and June 2023, we implemented changes to our organizational structure as part of an operational cost reduction plan and reorganization plan due to the transaction with Cell Ready. In connection with these changes, we reduced headcount, including the separation of our former Chief Executive Officer, Peter Hoang, and our former Chief Accounting Officer, Michael Loiacono. During the second quarter of 2023, we recorded $0.9 million of severance and termination-related costs. The payment of these costs were completed in July of 2023.

Effective May 1, 2023, our board of directors appointed Dr. Vera as our Chief Executive Officer.

Effective June 30, 2023, our board of directors appointed Eliot M. Lurier as our Interim Chief Financial Officer. Mr. Lurier provides consulting services to us pursuant to a consulting agreement between us and Danforth Advisors, LLC and receives no compensation directly from us.

Reverse Stock Split

On January 26, 2023, we effected the Reverse Stock Split and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All historical share and per share amounts reflected in this report have been adjusted to reflect the Reverse Stock Split.

Results of Operations

In this discussion of our results of operations and financial condition, amounts in financial tables, other than per-share amounts, have been rounded to the nearest thousand.

Comparison of the Three Months Ended June 30, 2023 and 2022

The following table summarizes the results of our continuing operations for the three months ended June 30, 2023 and 2022:


	For the Three Months Ended
	June 30,
	2023		2022		Change
Revenues:
Grant income	$	763,000	$	791,000	$	(28,000)	(4)	%
Total revenues		763,000		791,000		(28,000)	(4)	%
Operating expenses:
Research and development		2,378,000		2,924,000		(546,000)	(19)	%
General and administrative		2,519,000		3,135,000		(616,000)	(20)	%
Total operating expenses		4,897,000		6,059,000		(1,162,000)	(19)	%
Loss from operations		(4,134,000)		(5,268,000)		1,134,000	(22)	%
Other income (expenses):
Arbitration settlement		—		—		—	0	%
Interest income		35,000		36,000		(1,000)	(3)	%
Loss from continuing operations	$	(4,099,000)	$	(5,232,000)	$	1,133,000	(22)	%

Revenue

We did not generate any revenue during the three months ended June 30, 2023 and 2022, respectively, from the sales or licensing of our product candidates.

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In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas, or CPRIT, to support our Phase 2 clinical trial of MT-401. During the three months ended June 30, 2023, we recognized $0.7 million of revenue associated with the CPRIT grant.

In September 2022, we received notice from the FDA that it had awarded us a $2.0 million grant from the FDA’s Orphan Products Grant program to support our Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. During the three months ended June 30, 2023, we recognized $0.1 million of revenue associated with the FDA grant.

Operating Expenses

Operating expenses incurred during the three months ended June 30, 2023 were $4.9 million compared to $6.1 million during the three months ended June 30, 2022.

Significant changes and expenditures in operating expenses are outlined as follows:

Research and Development Expenses

Research and development expenses decreased by 19% to $2.4 million for the three months ended June 30, 2023, compared to $2.9 million for the three months ended June 30, 2022.

The decrease of $0.5 million in 2023 was primarily attributable to the following:

●

decrease of $0.3 million in process development expenses,

●

decrease of $0.1 million in stock-based compensation expenses,

●

decrease of $0.2 million in headcount-related expenses

●

decrease of $0.1 million in other expenses, offset by

●

increase of $0.2 million in clinical trial expenses.

General and Administrative Expenses

General and administrative expenses decreased by 20% to $2.5 million for the three months ended June 30, 2023, compared to $3.1 million for the three months ended June 30, 2022.

The decrease of $0.6 million in 2023 was primarily attributable to the following:

●

decrease of $0.6 million in stock-based compensation expenses,

●

decrease of $0.6 million in headcount-related expenses,

●

decrease of $0.3 million in rent expense, offset by

●

increase of $0.9 million in severance expenses.

Other Income (Expense)

Interest Income

Interest income was $35,000 and $36,000 for the three months ended June 30, 2023 and 2022, respectively, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.

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Comparison of the Six Months Ended June 30, 2023 and 2022

The following table summarizes the results of our continuing operations for the six months ended June 30, 2023 and 2022:


	For the Six Months Ended
	June 30,
	2023		2022		Change
Revenues:
Grant income	$	1,997,000	$	1,755,000	$	242,000	14	%
Total revenues		1,997,000		1,755,000		242,000	14	%
Operating expenses:
Research and development		5,754,000		6,194,000		(440,000)	(7)	%
General and administrative		4,686,000		6,486,000		(1,800,000)	(28)	%
Total operating expenses		10,440,000		12,680,000		(2,240,000)	(18)	%
Loss from operations		(8,443,000)		(10,925,000)		2,482,000	(23)	%
Other income (expenses):
Arbitration settlement		—		(119,000)		119,000	0	%
Interest income		120,000		39,000		81,000	208	%
Loss from continuing operations	$	(8,323,000)	$	(11,006,000)	$	2,683,000	(24)	%

Revenue

We did not generate any revenue during the six months ended June 30, 2023 and 2022, respectively, from the sales or licensing of our product candidates.

In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas, or CPRIT, to support our Phase 2 clinical trial of MT-401. During the six months ended June 30, 2023, we recognized $1.8 million of revenue associated with the CPRIT grant.

In September 2022, we received notice from the FDA that it had awarded us a $2.0 million grant from the FDA’s Orphan Products Grant program to support our Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. During the six months ended June 30, 2023, we recognized $0.2 million of revenue associated with the FDA grant.

Operating Expenses

Operating expenses incurred during the six months ended June 30, 2023 were $10.4 million compared to $12.7 million during the six months ended June 30, 2022.

Significant changes and expenditures in operating expenses are outlined as follows:

Research and Development Expenses

Research and development expenses decreased by 7% to $5.8 million for the six months ended June 30, 2023, compared to $6.2 million for the six months ended June 30, 2022.

The decrease of $0.4 million in 2023 was primarily attributable to the following:

●

decrease of $0.3 million in process development expenses,

●

decrease of $0.1 million in stock-based compensation expenses,

●

decrease of $0.1 million in headcount-related expenses

●

decrease of $0.5 million in sponsored research expenses from BCM agreements, offset by

●

increase of $0.2 million in clinical trial expenses,

●

increase of $0.1 million in rent expenses, and

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●

increase of $0.3 million in other expenses

General and Administrative Expenses

General and administrative expenses decreased by 28% to $4.7 million for the six months ended June 30, 2023, compared to $6.5 million for the six months ended June 30, 2022.

The decrease of $1.8 million in 2023 was primarily attributable to the following:

●

decrease of $1.2 million in stock-based compensation expenses,

●

decrease of $0.9 million in headcount-related expenses,

●

decrease of $0.6 million in rent expenses, offset by

●

increase of $0.9 million in severance expenses.

Other Income (Expense)

Arbitration Settlement

An arbitration proceeding was brought against us before the 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 FINRA panel found in favor of the broker and awarded the broker $2.4 million for compensation, interest and attorney fees, which we recorded in the year ended December 31, 2021. During the six months ended June 30, 2022, we recorded an additional $0.1 million of expense related to this matter.

Interest Income

Interest income was $0.1 million and $39,000 for the six months ended June 30, 2023 and 2022, respectively, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.

Liquidity and Capital Resources

We have not generated any revenues from product sales since inception. We have financed our operations primarily through public and private offerings of our debt and equity securities.

The following table sets forth our cash and cash equivalents and working capital as of June 30, 2023 and December 31, 2022:


	June 30,		December 31,
	2023		2022
Cash and cash equivalents	$	18,122,000	$	11,782,000
Working capital	$	19,035,000	$	8,837,000

Cash Flows

The following table summarizes our cash flows for the three months ended June 30, 2023 and 2022:


	For the Six Months Ended
	June 30,
	2023		2022
Net cash provided by (used in):
Operating activities	$	(12,945,000)	$	(13,021,000)
Investing activities		18,664,000		(4,719,000)
Financing activities		621,000		64,000
Net increase (decrease) in cash, cash equivalents and restricted cash (1)	$	6,340,000	$	(17,676,000)

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(1) As of June 30, 2022 and December 31, 2021, the Company had $0 and $1,146,186 of restricted cash, respectively.

Operating Activities

Net cash used in operating activities during the six months ended June 30, 2023 was $12.9 million compared to $13.0 million for the same period last year.

Net cash used in operating activities during the six months ended June 30, 2023 was $12.9 million. The changes in cash flow from operating activities during the six months ended June 30, 2023 were due to $8.3 million of net losses from continuing operations and a $0.7 million increase from changes in operating assets and liabilities and $5.8 million of cash used in discontinued operations. This was in addition to $0.5 million of stock-based compensation in continuing operations.

Net cash used in operating activities during the six months ended June 30, 2022 was $13.0 million. The changes in cash flow from operating activities during the six months ended June 30, 2022 were due to $11.0 million of net losses from continuing operations and a $3.1 million decrease from changes in operating assets and liabilities and $0.9 million of cash used in discontinued operations. This was in addition to $2.0 million of stock-based compensation.

Investing Activities

Net cash provided by investing activities was $18.7 million primarily from the sale of assets in discounted operations.

Net cash used in investing activities was $4.7 million for the purchase of property and equipment and construction in progress related to our manufacturing facility during the six months ended June 30, 2022.

Financing Activities

Net cash provided by financing activities was $0.6 million during the six months ended June 30, 2023, due to sales of common stock under the ATM Agreement and the Lincoln Park Purchase Agreement (as defined below).

Future Capital Requirements

To date, we have not generated any revenues from the commercial sale of approved drug products, and we do not expect to generate substantial revenue for at least the next several years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be compromised. We do not know when, or if, we will generate any revenue from our product candidates, and we do not expect to generate significant revenue unless and until we obtain regulatory approval of, and commercialize, our product candidates. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of and seek marketing approval for our product candidates. In addition, if we obtain approval for any of our product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

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. 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, we have received $6.9 million of funds from the CPRIT grant.

In September 2022, we received notice from the U.S. Food and Drug Administration, or the FDA, that it had awarded us a $2.0 million grant from the FDA’s Orphan Products Grant program to support our Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. To date, we have received $0.2 million of funds from the FDA grant.

On June 26, 2023, we completed the previously announced transaction with Cell Ready. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, we assigned and sold, as applicable, the Purchased Assets to Cell Ready. Following the Closing Date,

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we and Cell Ready have agreed to enter into a long-term contract with pursuant to which Cell Ready will perform a wide variety of services for us, including research and development, manufacturing, and regulatory activity in support of our clinical trials; however, the parties have not yet executed such agreement. Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of our former employees in our manufacturing, development, quality and regulatory affairs functions.

As of June 30, 2023, we had working capital of $19.0 million, compared to working capital of $8.8 million as of December 31, 2022. Based on our clinical development plans and the disposition of the Purchased Assets pursuant to the Cell Ready Purchase Agreement and related organizational restructuring, we expect that our cash and cash equivalents as of June 30, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Furthermore, our operating plans may change, and we 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 our product candidates and the extent to which we may enter into additional collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, as we:

●	initiate or continue clinical trials of our product candidates;

●	continue the research and development of our product candidates and seek to discover additional product candidates;seek regulatory approvals for our product candidates if they successfully complete clinical trials;

●	enter into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical manufacturing supply;

●	establish sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;

●	evaluate strategic transactions we may undertake; and

●	enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts.

Because all of our product candidates are in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, we may achieve profitability. Until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements.

We plan to continue to fund our operations and capital funding needs through existing cash and future equity and/or debt financing. We may also consider new collaborations or selectively partner our technology. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our existing stockholders’ common stock. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms unfavorable to us. We may also be required to pay damages or have liabilities associated with litigation or other legal proceedings involving our company.

ATM Agreement

In August 2021, we 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 we can offer and sell, from time to time at our sole discretion

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through the Sales Agents, shares of our common stock having an aggregate offering price of up to $75.0 million. Any shares of our common stock sold will be issued pursuant to our shelf registration statement on Form S-3 (File No. 333-258687), which the SEC declared effective on August 19, 2021. The shelf registration statement on Form S-3 includes a prospectus supplement covering the offering up to $9.87 million of shares of common stock over the 12 months ending March 22, 2024 pursuant to General Instruction I.B.6 of Form S-3, which limits the amounts that the Company may sell under the registration statement, and in accordance with the ATM agreement. 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 we have provided each of the Sales Agents with indemnification and contribution rights. During the three months ended June 30, 2023, we sold 200,261 shares of our common stock under the ATM Agreement for proceeds of $0.6 million.

Stock Purchase Agreement

In December 2022, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provides that, upon the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park up to $25,000,000 of shares of our common stock (the “Purchase Shares”) from time to time over a 24-month term, at a variable price with certain market-based terms as defined in the Purchase Agreement. The Purchase Agreement does not exhibit any of the characteristics for liability classification under ASC Topic 480, Distinguishing Liabilities from Equity. Instead, the purchase agreement is indexed to the Company’s own stock under ASC Subtopic 815-40, Contracts in Entity’s Own Equity, and classified as equity. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. During the three months ended June 30, 2023, we sold 12,500 shares of our common stock under the Purchase Agreement for proceeds of approximately $33,000.

Critical Accounting Policies

The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses in the periods presented. We believe that the accounting estimates employed are appropriate and resulting balances are reasonable; however, due to inherent uncertainties in making estimates, actual results could differ from the original estimates, requiring adjustments to these balances in future periods. The critical accounting estimates that affect the condensed consolidated financial statements and the judgments and assumptions used are consistent with those described under Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2022.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures

(a)Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on such evaluation, our Chief Executive Officer and our Chief Accounting Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the Exchange Act.

It should be noted that any system of controls is based in part upon certain assumptions designed to obtain reasonable (and not absolute) assurance as to its effectiveness, and there can be no assurance that any design will succeed in achieving its stated goals.

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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. Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been or will be detected.

(b)Changes in Internal Control Over Financial Reporting

There have been no changes in our internal controls over financial reporting during the three months ended June 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.

Item 1A. Risk Factors

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on March 12, 2023. There have been no material changes to the risk factors described in that report, other than as described below.

We may not realize the expected benefits from the transaction with Cell Ready.

We may not be able to achieve the full strategic and financial benefits expected to result from the closing of the transaction with Cell Ready, or such benefits may be delayed or not occur at all. In particular, we have made the strategic decision to dispose of our manufacturing facilities and related assets in order to focus on clinical development of the multiTAA-specific T cell therapy-based product candidates in our pipeline. Following the closing of the transaction, we no longer operate our own cGMP manufacturing facility and must rely on third parties for the clinical and, if approved, commercial manufacture of our product candidates. Although we intend to enter into a long-term agreement with Cell Ready for manufacturing, among other services, we have not yet executed such agreement and may not realize the anticipated cost savings associated with contracting out our manufacturing, research and development and regulatory requirements. The assumptions we made related to the Cell Ready transaction may prove to be inaccurate, including as to the expected benefits of the transaction and anticipated cost savings. Further, the transition activities following closing may disrupt our operations and divert management’s attention to our business, particularly because our Chief Executive Officer, Dr. Juan Vera, expects to perform consulting work for Cell Ready in addition to his duties for our company. An inability to realize the anticipated benefits of the Cell Ready transaction could have an adverse impact on our business, financial condition and results of operations.

Following the closing of the transaction with Cell Ready, we no longer operate our own cGMP manufacturing facility and instead will rely on third parties, including Cell Ready, for the clinical and, if approved, commercial manufacture of our product candidates. The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory requirements.

We do not have any cGMP manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the cGMP manufacture of our product candidates for clinical development and, if approved, commercial supply. We intend to enter into a long-term agreement with Cell Ready, pursuant to which Cell Ready will perform a wide variety of services for us, including research and development, manufacturing and regulatory activity in support of our clinical trials; however, we have not yet executed such agreement. There is no guarantee that we will or have properly estimated our required manufacturing capacities or that the third parties we rely on to provide required machinery and materials for the manufacturing process will be able to perform on our proposed timelines or meet

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our manufacturing demands, if at all. Also, if we must increase production capacity for any reason, we may need to make considerable investments that could lead to significant financing needs or require us to enter into subcontracting agreements in order to outsource part of the production.

If Cell Ready or any other third-party contract manufacturing organization on which we rely experiences capacity constraints, other disruptions, or delays in manufacturing our multiTAA-specific T cell therapy-based product candidates, our planned clinical trials and necessary manufacturing capabilities will be disrupted or delayed. Third-party manufacturers may not be able to meet our needs concerning timing, quantity, or quality. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products. Any such delay may lower our revenues and potential profitability. If any third party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked completely. It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration with others, as a means for developing treatments for the diseases targeted by our collaborative programs, or for other reasons. The effectiveness of these third parties in marketing their own products may also affect our revenues and earnings. We intend to continue to enter into additional third-party agreements in the future. However, we may not be able to negotiate any additional agreements successfully. Even if established, these relationships may not be scientifically or commercially successful.

The facilities used by our contract manufacturers to manufacture our product candidates must be inspected by the FDA. We do not have control over a supplier’s or manufacturer’s compliance with laws, regulations and applicable cGMP standards or similar regulatory requirements and other laws and regulations, such as those related to environmental health and safety matters. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, we may be unable to obtain regulatory approval of our marketing applications. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supply of our products.

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, cause us to incur higher costs and prevent us from commercializing our products successfully, if approved. Furthermore, if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed or we could lose potential revenue.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

We did not record any issuances of unregistered securities during the six months ended June 30, 2023.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosure

Not applicable.

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Item 5. Other Information

Not applicable.

Item 6. Exhibits

The following exhibits are included with this Quarterly Report on Form 10-Q:

Incorporated by Reference

Exhibit
number

Exhibit description

Form

File no.

Exhibit

Filing
date

Filed
herewith

3.1

Certificate of Incorporation (Delaware).

8-K

001-37939

3.4

10/17/18

3.1.1

Certificate of Amendment to Certificate of Incorporation.

8-K

001-37939

3.1

5/27/2022

3.1.2

Certificate of Amendment to Amended and Restated Certificate of Incorporation

8-K

001-37939

3.1

1/26/2023

3.2

Bylaws of Marker Therapeutics, Inc.

8-K

001-37939

3.6

10/17/18

10.1

Separation Agreement between Marker Therapeutics, Inc. and Peter Hoang dated as of April 27, 2023.

10-Q

001-37939

10.1

5/15/2023

10.2#

Purchase Agreement between Cell Ready, LLC and Marker Therapeutics, Inc., dated May 1, 2023

10-Q

001-37939

10.2

5/15/2023

31.1

Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1933, as amended.

31.2

Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1933, as amended.

32.1^*

Certification of Chief Executive Officer Pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2^*

Certification of Chief Financial Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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Exhibit 101

101.INS - XBRL Instance Document

101.SCH - XBRL Taxonomy Extension Schema Document

101.CAL - XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF - XBRL Taxonomy Extension Definition Linkbase Document

101.LAB - XBRL Taxonomy Extension Label Linkbase Document

101.PRE - XBRL Taxonomy Extension Presentation Linkbase Document

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

Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

#	Certain schedules to this agreement have been omitted in accordance with Item 601(b)(2) of Regulation S-K. A copy of any omitted schedules will be furnished supplementally to the SEC upon request.

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SIGNATURES

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: August 14, 2023

MARKER THERAPEUTICS, INC.

	/s/ Juan Vera
	Juan Vera
	President, Chief Executive Officer and Principal Executive Officer

	/s/ Eliot M. Lurier
	Eliot M. Lurier
	Interim Chief Financial Officer and Interim Principal Financial and Accounting Officer

Exhibit 31.1

CERTIFICATION

I, Juan Vera, certify that:

(1)	I have reviewed this Quarterly Report on Form 10-Q of Marker Therapeutics, Inc.;

(2)	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

(3)	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(4)

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurances regarding the reliability of financial reporting in the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

(5)	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date:	August 14, 2023

/s/ Juan Vera
By:	Juan Vera
Title:	Chief Executive Officer (Principal Executive Officer)

Exhibit 31.2

CERTIFICATION

I, Eliot M. Lurier, certify that:

(1)	I have reviewed this Quarterly Report on Form 10-Q of Marker Therapeutics, Inc.;

(2)	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

(3)	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(4)

(a)

(b)

(c)

(d)

(5)	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date:	August 14, 2023

/s/ Eliot M. Lurier
By:	Eliot M. Lurier
Title:	Interim Chief Financial Officer (Interim Principal Financial and Accounting Officer)

Exhibit 32.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

The undersigned, Juan Vera, the Chief Executive Officer of Marker Therapeutics, Inc. (the “Company”) hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge, the Quarterly Report on Form 10-Q for the period ended June 30, 2023, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and that the information contained in the Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of the Company.

Date:	August 14, 2023

	/s/ Juan Vera
	Juan Vera
	Chief Executive Officer (Principal Executive Officer)

Exhibit 32.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

The undersigned, Eliot M. Lurier, the Interim Chief Financial Officer of Marker Therapeutics, Inc. (the “Company”) hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge, the Quarterly Report on Form 10-Q for the period ended June 30, 2023, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and that the information contained in the Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of the Company.

Date:	August 14, 2023

	/s/ Eliot M. Lurier
	Eliot M. Lurier
	Interim Chief Financial Officer (Interim Principal Financial and Accounting Officer)

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2023	Aug. 08, 2023
Entity Addresses [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-37939
Entity Registrant Name	MARKER THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-4497941
Entity Address, Address Line One	9350 Kirby Drive, Suite 300
Entity Address, City or Town	Houston
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77054
City Area Code	713
Local Phone Number	400-6400
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	MRKR
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		8,809,260
Entity Central Index Key	0001094038
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false
Former Address
Entity Addresses [Line Items]
Entity Information, Former Legal or Registered Name	4551 Kennedy Commerce Drive, Houston, Texas, 77032

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 18,122,086	$ 11,782,172
Prepaid expenses and deposits	2,087,462	1,849,239
Other receivables	1,746,100	2,402,004
Current assets of discontinued operations		585,840
Total current assets	21,955,648	16,619,255
Non-current assets of discontinued operations		17,802,929
Total assets	21,955,648	34,422,184
Current liabilities:
Accounts payable and accrued liabilities	2,660,616	2,521,193
Current liabilities of discontinued operations	260,280	5,260,616
Total current liabilities	2,920,896	7,781,809
Non-current liabilities of discontinued operations		7,039,338
Total liabilities	2,920,896	14,821,147
Stockholders' equity:
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
Common stock, $0.001 par value, 30 million shares authorized, 8.8 million and 8.4 million shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	8,799	8,406
Additional paid-in capital	449,526,789	447,641,680
Accumulated deficit	(430,500,836)	(428,049,049)
Total stockholders' equity	19,034,752	19,601,037
Total liabilities and stockholders' equity	$ 21,955,648	$ 34,422,184

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Preferred stock par value (per share)	$ 0.001	$ 0.001
Preferred stock authorized	5,000,000	5,000,000
Preferred stock issued	0	0
Preferred stock outstanding	0	0
Common stock par value (per share)	$ 0.001	$ 0.001
Common stock authorized	30,000,000	30,000,000
Common stock issued	8,800,000	8,400,000
Common stock outstanding	8,800,000	8,400,000

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Revenues:
Total revenues	$ 762,658	$ 790,508	$ 1,996,995	$ 1,754,830
Operating expenses:
Research and development	2,377,993	2,923,877	5,754,492	6,194,241
General and administrative	2,518,725	3,135,168	4,686,044	6,486,465
Total operating expenses	4,896,718	6,059,045	10,440,536	12,680,706
Loss from operations	(4,134,060)	(5,268,537)	(8,443,541)	(10,925,876)
Other income (expenses):
Arbitration settlement				(118,880)
Interest income	35,080	35,786	119,734	38,902
Loss from continuing operations	(4,098,980)	(5,232,751)	(8,323,807)	(11,005,854)
Discontinued operations:
Loss from discontinued operations before income taxes	(2,179,657)	(4,011,437)	(2,922,406)	(8,148,842)
Gain on disposal of discontinued operations	8,794,426		8,794,426
Income (loss) from discontinued operations	6,614,769	(4,011,437)	5,872,020	(8,148,842)
Net income (loss)	$ 2,515,789	$ (9,244,188)	$ (2,451,787)	$ (19,154,696)
Net earnings (loss) per share, basic and diluted:
Loss from continuing operations, basic	$ (0.47)	$ (0.63)	$ (0.95)	$ (1.32)
Income (loss) from discontinued operations, basic	0.75	(0.48)	0.67	(0.98)
Net earnings (loss) per share, basic	0.29	(1.11)	(0.28)	(2.30)
Loss from continuing operations, diluted	(0.47)	(0.63)	(0.95)	(1.32)
Income (loss) from discontinued operations, diluted	0.75	(0.48)	0.67	(0.98)
Net earnings (loss) per share, diluted	$ 0.29	$ (1.11)	$ (0.28)	$ (2.30)
Weighted average number of common shares outstanding, basic	8,798,956	8,359,205	8,760,209	8,335,119
Weighted average number of common shares outstanding, diluted	8,798,956	8,359,205	8,760,209	8,335,119
Grant income
Revenues:
Total revenues	$ 762,658	$ 790,508	$ 1,996,995	$ 1,754,830

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical)	Jan. 26, 2023
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Reverse stock split	1-for-10

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid- in Capital	Accumulated Deficit	Total
Beginning Balance at Dec. 31, 2021	$ 8,308	$ 442,095,642	$ (398,118,355)	$ 43,985,595
Beginning Balance, Shares at Dec. 31, 2021	8,307,868
Issuance of common stock for cash	$ 15	63,558		63,573
Issuance of common stock for cash (in shares)	14,800
Stock-based compensation	$ 37	3,131,764		3,131,801
Stock-based compensation (in shares)	37,251
Net Income (loss)			(19,154,696)	(19,154,696)
Ending Balance at Jun. 30, 2022	$ 8,360	445,290,964	(417,273,051)	28,026,273
Ending Balance, Shares at Jun. 30, 2022	8,359,919
Beginning Balance at Mar. 31, 2022	$ 8,345	443,726,282	(408,028,863)	35,705,764
Beginning Balance, Shares at Mar. 31, 2022	8,345,119
Issuance of common stock for cash	$ 15	63,558		63,573
Issuance of common stock for cash (in shares)	14,800
Stock-based compensation		1,501,124		1,501,124
Net Income (loss)			(9,244,188)	(9,244,188)
Ending Balance at Jun. 30, 2022	$ 8,360	445,290,964	(417,273,051)	28,026,273
Ending Balance, Shares at Jun. 30, 2022	8,359,919
Beginning Balance at Dec. 31, 2022	$ 8,406	447,641,680	(428,049,049)	19,601,037
Beginning Balance, Shares at Dec. 31, 2022	8,405,771
Ending Balance at Mar. 31, 2023	$ 8,799	448,921,174	(433,016,625)	15,913,348
Ending Balance, Shares at Mar. 31, 2023	8,798,829
Beginning Balance at Dec. 31, 2022	$ 8,406	447,641,680	(428,049,049)	19,601,037
Beginning Balance, Shares at Dec. 31, 2022	8,405,771
Issuance of common stock for cash	$ 213	619,761		619,974
Issuance of common stock for cash (in shares)	212,761
Issuance of common stock from exercise of stock options		736		$ 736
Stock options exercised for cash (in shares)	344			344
Issuance of common stock as commitment fee for future financing	$ 180	(180)
Issuance of common stock as commitment fee for future financing (Shares)	180,410
Stock-based compensation	$ 0	1,264,792	0	$ 1,264,792
Stock-based compensation (in shares)	0
Net Income (loss)			(2,451,787)	(2,451,787)
Fractional shares adjustment due to reverse split	(113)
Ending Balance at Jun. 30, 2023	$ 8,799	449,526,789	(430,500,836)	19,034,752
Ending Balance, Shares at Jun. 30, 2023	8,799,173
Beginning Balance at Mar. 31, 2023	$ 8,799	448,921,174	(433,016,625)	15,913,348
Beginning Balance, Shares at Mar. 31, 2023	8,798,829
Issuance of common stock from exercise of stock options		736		736
Stock options exercised for cash (in shares)	344
Stock-based compensation		604,879		604,879
Net Income (loss)			2,515,789	2,515,789
Ending Balance at Jun. 30, 2023	$ 8,799	$ 449,526,789	$ (430,500,836)	$ 19,034,752
Ending Balance, Shares at Jun. 30, 2023	8,799,173

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical)	Jan. 26, 2023
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
Reverse stock split	1-for-10

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)

6 Months Ended

Jun. 30, 2023

Jun. 30, 2022

Cash Flows from Operating Activities:

Net loss

$ (2,451,787)

$ (19,154,696)

Less: gain (loss) from discontinued operations, net of tax

5,872,020

(8,148,842)

Net loss from continuing operations

(8,323,807)

(11,005,854)

Reconciliation of net loss to net cash used in operating activities:

Stock-based compensation

539,858

1,986,402

Changes in operating assets and liabilities:

Prepaid expenses and deposits

(238,223)

(309,254)

Other receivables

655,904

(627,392)

Accounts payable and accrued expenses

197,030

(1,061,562)

Deferred revenue

(1,146,186)

Net cash used in operating activities - continuing operations

(7,169,238)

(12,163,846)

Net cash used in operating activities - discontinued operations

(5,775,680)

(856,922)

Net cash used in operating activities

(12,944,918)

(13,020,768)

Cash Flows from Investing Activities:

Net cash provided by (used in) investing activities - discontinued operations

18,664,122

(4,718,428)

Net cash provided by (used in) investing activities

18,664,122

(4,718,428)

Cash Flows from Financing Activities:

Proceeds from issuance of common stock, net

619,974

63,573

Proceeds from stock options exercise

736

Net cash provided by financing activities

620,710

63,573

Net increase (decrease) in cash, cash equivalents and restricted cash

^[1]

6,339,914

(17,675,623)

Cash, cash equivalents and restricted cash at beginning of the period

^[1]

11,782,172

43,497,331

Cash and cash equivalents at end of the period

18,122,086

25,821,708

Supplemental schedule of non-cash financing and investing activities:

Changes between assets and liabilities in discontinued operations

141,979

$ 25,025

Issuance of common stock as commitment fee for future financing

$ 180

[1]	As of June 30, 2022 and December 31, 2021, the Company had $0 and $1,146,186 of restricted cash, respectively.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($)	Jun. 30, 2022	Dec. 31, 2021
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Restricted cash	$ 0	$ 1,146,186

NATURE OF OPERATIONS

6 Months Ended

Jun. 30, 2023

NATURE OF OPERATIONS

NATURE OF OPERATIONS

NOTE 1: NATURE OF OPERATIONS

Purchase Agreement With Cell Ready

Reverse Stock Split

Organizational Restructuring

Effective May 1, 2023, the Company’s board of directors appointed Dr. Vera as the Company’s Chief Executive Officer.

BASIS OF PRESENTATION

6 Months Ended

Jun. 30, 2023

BASIS OF PRESENTATION

BASIS OF PRESENTATION

NOTE 2: BASIS OF PRESENTATION

LIQUIDITY AND FINANCIAL CONDITION

6 Months Ended

Jun. 30, 2023

LIQUIDITY AND FINANCIAL CONDITION

LIQUIDITY AND FINANCIAL CONDITION

NOTE 3: LIQUIDITY AND FINANCIAL CONDITION

●	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;

●	enters into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical manufacturing supply;

●	establishes sales, marketing and distribution infrastructure and establishes third-party 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.

SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2023

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 4: SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

Discontinued Operations

Modification of Stock Options

New Accounting Standards

NET LOSS PER SHARE

6 Months Ended

Jun. 30, 2023

NET LOSS PER SHARE

NET LOSS PER SHARE

NOTE 5: NET LOSS PER SHARE

The following table sets forth the computation of net loss per share for the three and six months ended June 30, 2023 and 2022, respectively:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Loss from continuing operations	$	(4,098,980)	$	(5,232,751)	$	(8,323,807)	$	(11,005,854)
Income (loss) from discontinued operations	$	6,614,769	$	(4,011,437)	$	5,872,020	$	(8,148,842)
Net income (loss)	$	2,515,789	$	(9,244,188)	$	(2,451,787)	$	(19,154,696)

Denominator:
Weighted average common shares outstanding, basic and diluted		8,798,956		8,359,205		8,760,209		8,335,119

Net loss per share, basic and diluted:
Loss from continuing operations	$	(0.47)	$	(0.63)	$	(0.95)	$	(1.32)
Income (loss) from discontinued operations	$	0.75	$	(0.48)	$	0.67	$	(0.98)
Net income (loss)	$	0.29	$	(1.11)	$	(0.28)	$	(2.30)

The following securities, rounded to the nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:


	For the Three and Six Months Ended
	June 30,
	2023	2022
Common stock options	1,143,000	995,900
Common stock purchase warrants	1,848,000	1,848,200
Potentially dilutive securities	2,991,000	2,844,100

All common stock options and common stock purchase warrants outstanding as of June 30, 2023 were out of the money and were not included in net loss per share calculation.

DISCONTINUED OPERATIONS

6 Months Ended

Jun. 30, 2023

DISCONTINUED OPERATIONS

DISCONTINUED OPERATIONS

NOTE 6: DISCONTINUED OPERATIONS

The assets and liabilities classified in discontinued operations as of June 30, 2023 and December 31, 2022 are as follows:


	June 30, 2023		December 31, 2022
Prepaid expenses and other current assets	$	—	$	585,840
Total current assets of discontinued operations				585,840
Fixed Assets		—		12,323,143
Right of use assets		—		5,479,786
Total non-current assets of discontinued operations				17,802,929
Total assets of discontinued operations	$	—	$	18,388,769

Accounts payable	$	260,280	$	2,183,418
Related party deferred revenue		—		2,500,000
Short-term lease liabilities		—		577,198
Total current liabilities of discontinued operations		260,280		5,260,616
Long-term lease liabilities		—		7,039,338
Total non-current liabilities of discontinued operations		—		7,039,338
Total liabilities of discontinued operations	$	260,280	$	12,299,954

The Company reclassified the following operations to discontinued operations for the three and six months ended June 30, 2023 and 2022, respectively, excluding the gain on disposal:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Revenues:
Service revenue	$	816,641	$	—	$	816,641	$	—
Related party service revenue		—		—		3,500,000		—
Total revenues		816,641		—		4,316,641		—
Operating expenses:
Research and development		2,667,712		3,631,422		6,561,957		7,387,124
General and administrative		328,585		380,015		677,090		761,719
Total operating expenses		2,996,297		4,011,437		7,239,048		8,148,842
Loss from discontinued operations	$	(2,179,657)	$	(4,011,437)	$	(2,922,406)	$	(8,148,842)

Related Party Service Revenue

Service Revenue

PROPERTY AND EQUIPMENT

6 Months Ended

Jun. 30, 2023

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

NOTE 7: PROPERTY AND EQUIPMENT

Substantially all of the previously reported property and equipment was disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.

LEASES

6 Months Ended

Jun. 30, 2023

LEASES

LEASES

NOTE 8: LEASES

Substantially all of the previously reported leases were disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

6 Months Ended

Jun. 30, 2023

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

NOTE 9: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

Accounts payable and accrued liabilities consist of the following as of June 30, 2023 and December 31, 2022, respectively:


	June 30,		December 31,
	2023		2022
Accounts payable	$	1,330,000	$	1,101,000
Compensation and benefits		610,000		750,000
Process development expenses		—		—
Professional fees		525,000		518,000
Arbitration settlement fees		—		114,000
Other		196,000		38,000
Total accounts payable and accrued liabilities	$	2,661,000	$	2,521,000

STOCKHOLDERS' EQUITY

6 Months Ended

Jun. 30, 2023

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 10: STOCKHOLDERS’ EQUITY

Reverse Stock Split

Common Stock Transactions

Issuance of Stock Pursuant to ATM Agreement

During the six months ended June 30, 2023, the Company sold 200,261 shares of its common stock under the ATM Agreement for proceeds of $0.6 million.

Stock Purchase Agreement

Exercise of Stock Options

During the six months ended June 30, 2023, certain outstanding options were exercised for 344 shares of common stock, providing aggregate proceeds to the Company of approximately $700.

Share Purchase Warrants

A summary of the Company’s share purchase warrants as of June 30, 2023 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, 2023	1,848,000	$	44.51	0.79	$	—
Expired or cancelled	—		—	—		—
Balance - June 30, 2023	1,848,000	$	44.51	0.30	$	—

STOCK-BASED COMPENSATION

6 Months Ended

Jun. 30, 2023

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

NOTE 11: STOCK-BASED COMPENSATION

Stock Options

2022 Equity Incentive Awards

A summary of the Company’s stock option activity for the three months ended June 30, 2023 is as follows:


						Weighted Average
						Remaining
		Weighted Average				Contractual
	Number of Shares	Exercise Price		Total Intrinsic Value		Life (in years)
Outstanding as of January 1, 2023	886,173	$	42.90	$	—	7.3
Granted	544,532		1.99		—	9.7
Exercised	(344)		2.14		—	—
Canceled/Expired	(287,803)		7.57		—	—
Outstanding as of June 30, 2023	1,142,558	$	32.30	$	455,000	6.9
Options vested and exercisable	687,689	$	50.53	$	26,000	5.3


	For the Six Months Ended
	June 30, 2023
Exercise price	$	1.99
Expected term (years)		6.0
Expected stock price volatility		91	%
Risk-free rate of interest		4	%
Expected dividend rate		0	%

The following table sets forth stock-based compensation expenses recorded during the respective periods:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Stock Compensation expenses:
Research and development	$	42,000	$	200,000	$	193,000	$	398,000
General and administrative		127,000		739,000		347,000		1,588,000
Stock compensation in continuing operations		169,000		939,000		540,000		1,986,000
Stock compensation in discontinued operations		437,000		563,000		725,000		1,146,000
Total stock compensation expenses	$	606,000	$	1,502,000	$	1,265,000	$	3,132,000

GRANT INCOME

6 Months Ended

Jun. 30, 2023

GRANT INCOME

GRANT INCOME

NOTE 12: GRANT INCOME

CPRIT

FDA

LEGAL PROCEEDINGS

6 Months Ended

Jun. 30, 2023

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS

NOTE 13: LEGAL PROCEEDINGS

RELATED PARTY EXPENSES

6 Months Ended

Jun. 30, 2023

RELATED PARTY EXPENSES

RELATED PARTY EXPENSES

NOTE 14: RELATED PARTY EXPENSES

The following table sets forth related party transaction expenses recorded for the three and six months ended June 30, 2023 and 2022, respectively.


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Baylor College of Medicine	$	2,000	$	285,000	$	13,000	$	1,142,000
Bio-Techne Corporation		—		—		—		101,000
Wilson Wolf Manufacturing Corporation		73,000		46,000		277,000		101,000
Total Research and development	$	75,000	$	331,000	$	290,000	$	1,344,000

No related party transactions are included in accounts payable and accrued liabilities as of June 30, 2023.

Agreements with The Baylor College of Medicine (“BCM”).

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 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.

The Company has also entered into a Clinical Site Agreement with BCM, which provided for BCM to conduct clinical trials for the Company and is a part of continuing operations.

Purchases from Bio-Techne Corporation.

Purchases from Wilson Wolf.

SIGNIFICANT ACCOUNTING POLICIES (Policies)	6 Months Ended
SIGNIFICANT ACCOUNTING POLICIES (Policies)	Jun. 30, 2023
SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation	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 (see Note 6 for information on discontinued operations).
Discontinued Operations	Discontinued Operations The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its operations and financial results. Therefore, the Purchased Assets, related party revenue, service revenue and related expenses are classified as discontinued operations for all periods presented herein. See Note 6 for further information.
Modification of Stock Options	Modification of Stock Options During the three and six months ended June 30, 2023, the Company recorded incremental stock-based compensation expense of $0.2 million pertaining to the modification of stock options in connection with the termination of certain employees, including individuals that were hired by Cell Ready. The modification provided for an acceleration of unvested options, resulting in $0.2 million in compensation expense that was immediately recognized, and is reflected in loss from discontinued operations.
New Accounting Standards	New Accounting Standards From time to time, new accounting pronouncements are issued by Financial Accounting Standards Board (“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 consolidated financial position or results of operations upon adoption. There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2022 filed on March 22, 2023.

NET LOSS PER SHARE (Tables)

6 Months Ended

Jun. 30, 2023

NET LOSS PER SHARE

Schedule of computation of net loss per share


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Loss from continuing operations	$	(4,098,980)	$	(5,232,751)	$	(8,323,807)	$	(11,005,854)
Income (loss) from discontinued operations	$	6,614,769	$	(4,011,437)	$	5,872,020	$	(8,148,842)
Net income (loss)	$	2,515,789	$	(9,244,188)	$	(2,451,787)	$	(19,154,696)

Denominator:
Weighted average common shares outstanding, basic and diluted		8,798,956		8,359,205		8,760,209		8,335,119

Net loss per share, basic and diluted:
Loss from continuing operations	$	(0.47)	$	(0.63)	$	(0.95)	$	(1.32)
Income (loss) from discontinued operations	$	0.75	$	(0.48)	$	0.67	$	(0.98)
Net income (loss)	$	0.29	$	(1.11)	$	(0.28)	$	(2.30)

Schedule of anti-dilutive securities


	For the Three and Six Months Ended
	June 30,
	2023	2022
Common stock options	1,143,000	995,900
Common stock purchase warrants	1,848,000	1,848,200
Potentially dilutive securities	2,991,000	2,844,100

DISCONTINUED OPERATIONS (Tables)

6 Months Ended

Jun. 30, 2023

DISCONTINUED OPERATIONS

Schedule of balance sheet and income statement information of discontinued operations


	June 30, 2023		December 31, 2022
Prepaid expenses and other current assets	$	—	$	585,840
Total current assets of discontinued operations				585,840
Fixed Assets		—		12,323,143
Right of use assets		—		5,479,786
Total non-current assets of discontinued operations				17,802,929
Total assets of discontinued operations	$	—	$	18,388,769

Accounts payable	$	260,280	$	2,183,418
Related party deferred revenue		—		2,500,000
Short-term lease liabilities		—		577,198
Total current liabilities of discontinued operations		260,280		5,260,616
Long-term lease liabilities		—		7,039,338
Total non-current liabilities of discontinued operations		—		7,039,338
Total liabilities of discontinued operations	$	260,280	$	12,299,954


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Revenues:
Service revenue	$	816,641	$	—	$	816,641	$	—
Related party service revenue		—		—		3,500,000		—
Total revenues		816,641		—		4,316,641		—
Operating expenses:
Research and development		2,667,712		3,631,422		6,561,957		7,387,124
General and administrative		328,585		380,015		677,090		761,719
Total operating expenses		2,996,297		4,011,437		7,239,048		8,148,842
Loss from discontinued operations	$	(2,179,657)	$	(4,011,437)	$	(2,922,406)	$	(8,148,842)

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

6 Months Ended

Jun. 30, 2023

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

Schedule of accounts payable and accrued liabilities


	June 30,		December 31,
	2023		2022
Accounts payable	$	1,330,000	$	1,101,000
Compensation and benefits		610,000		750,000
Process development expenses		—		—
Professional fees		525,000		518,000
Arbitration settlement fees		—		114,000
Other		196,000		38,000
Total accounts payable and accrued liabilities	$	2,661,000	$	2,521,000

STOCKHOLDERS' EQUITY (Tables)

6 Months Ended

Jun. 30, 2023

STOCKHOLDERS' EQUITY (Tables)

Schedule of share purchase warrants


				Weighted Average
	Number of	Weighted Average		Remaining Contractual	Total Intrinsic
	Warrants	Exercise Price		Life (in years)	Value
Balance - January 1, 2023	1,848,000	$	44.51	0.79	$	—
Expired or cancelled	—		—	—		—
Balance - June 30, 2023	1,848,000	$	44.51	0.30	$	—

STOCK BASED COMPENSATION (Tables)

6 Months Ended

Jun. 30, 2023

STOCK-BASED COMPENSATION

Schedule of the company's stock option activity


						Weighted Average
						Remaining
		Weighted Average				Contractual
	Number of Shares	Exercise Price		Total Intrinsic Value		Life (in years)
Outstanding as of January 1, 2023	886,173	$	42.90	$	—	7.3
Granted	544,532		1.99		—	9.7
Exercised	(344)		2.14		—	—
Canceled/Expired	(287,803)		7.57		—	—
Outstanding as of June 30, 2023	1,142,558	$	32.30	$	455,000	6.9
Options vested and exercisable	687,689	$	50.53	$	26,000	5.3

Schedule of weighted average assumptions used in calculating the fair values of stock options that were granted


	For the Six Months Ended
	June 30, 2023
Exercise price	$	1.99
Expected term (years)		6.0
Expected stock price volatility		91	%
Risk-free rate of interest		4	%
Expected dividend rate		0	%

Schedule of stock-based compensation expenses


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Stock Compensation expenses:
Research and development	$	42,000	$	200,000	$	193,000	$	398,000
General and administrative		127,000		739,000		347,000		1,588,000
Stock compensation in continuing operations		169,000		939,000		540,000		1,986,000
Stock compensation in discontinued operations		437,000		563,000		725,000		1,146,000
Total stock compensation expenses	$	606,000	$	1,502,000	$	1,265,000	$	3,132,000

RELATED PARTY EXPENSES (Tables)

6 Months Ended

Jun. 30, 2023

RELATED PARTY EXPENSES


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Baylor College of Medicine	$	2,000	$	285,000	$	13,000	$	1,142,000
Bio-Techne Corporation		—		—		—		101,000
Wilson Wolf Manufacturing Corporation		73,000		46,000		277,000		101,000
Total Research and development	$	75,000	$	331,000	$	290,000	$	1,344,000

NATURE OF OPERATIONS (Details)			3 Months Ended
NATURE OF OPERATIONS (Details)	Jun. 26, 2023 USD ($) employee	Jan. 26, 2023 USD ($) shares	Jun. 30, 2023 USD ($) shares	Dec. 31, 2022 shares
NATURE OF OPERATIONS
Reverse stock split		1-for-10
Common stock authorized \| shares			30,000,000	30,000,000
Reverse stock split value		$ 394.80
Severance and termination-related costs			$ 900,000
Cell Ready Agreement [Member]
NATURE OF OPERATIONS
Consideration for purchased assets	$ 19,000,000.0
Number of former employees offered employment \| employee	50
Cell Ready Agreement [Member] \| Discontinued Operations, Disposed of by Sale [Member]
NATURE OF OPERATIONS
Consideration for purchased assets	$ 19,000,000.0
Number of former employees offered employment \| employee	50
Maximum
NATURE OF OPERATIONS
Common stock authorized \| shares		300,000,000
Minimum
NATURE OF OPERATIONS
Common stock authorized \| shares		30,000,000

LIQUIDITY AND FINANCIAL CONDITION (Details)			1 Months Ended	3 Months Ended				6 Months Ended		12 Months Ended
LIQUIDITY AND FINANCIAL CONDITION (Details)	Jun. 26, 2023 USD ($) employee	Aug. 31, 2021 USD ($)	Jan. 31, 2023 USD ($) shares	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Mar. 31, 2023 shares	Jun. 30, 2022 USD ($) shares	Jun. 30, 2023 USD ($) shares	Jun. 30, 2022 USD ($) shares	Dec. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)
LIQUIDITY AND FINANCIAL CONDITION
Cash and cash equivalents					$ 18,122,086			$ 18,122,086		$ 11,782,172
Proceeds from issuance of common stock, net								619,974	$ 63,573
Amount of notice received		$ 13,100,000
Funds received from CPRIT grant								6,900,000
Grant receivable											$ 2,000,000.0
Revenue recognized					762,658		$ 790,508	1,996,995	1,754,830
Total compensation amount								$ 539,858	$ 1,986,402
Common Stock
LIQUIDITY AND FINANCIAL CONDITION
Number of shares issued \| shares							14,800	212,761	14,800
Grant income
LIQUIDITY AND FINANCIAL CONDITION
Revenue from CPRIT					700,000			$ 1,800,000
Revenue recognized					762,658		$ 790,508	1,996,995	$ 1,754,830
FDA grant
LIQUIDITY AND FINANCIAL CONDITION
Grant receivable											$ 2,000,000.0
Revenue recognized					$ 100,000			200,000
Lincoln Park
LIQUIDITY AND FINANCIAL CONDITION
Commitment fee			$ 500,000
Lincoln Park \| Common Stock
LIQUIDITY AND FINANCIAL CONDITION
Number of shares issued \| shares						12,500
Proceeds from issuance of common stock, net								$ 33,000
Stock issued during period other										$ 25,000,000
Stock issued during period other (in shares) \| shares			180,410
Subsequent event \| AlloVir, Inc
LIQUIDITY AND FINANCIAL CONDITION
Total compensation amount				$ 400,000
ATM Agreement
LIQUIDITY AND FINANCIAL CONDITION
Aggregate offering price		75,000,000.0
ATM Agreement \| Sales Agents
LIQUIDITY AND FINANCIAL CONDITION
Aggregate offering price		$ 9,870,000
Commission rate		3.00%
Number of shares issued \| shares								200,261
Proceeds from issuance of common stock, net								$ 600,000
Cell Ready Purchase Agreement
LIQUIDITY AND FINANCIAL CONDITION
Consideration for purchased assets	$ 19,000,000.0
Offers employment to number of employees \| employee	50

SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Millions	3 Months Ended	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2023
Significant Accounting Policies
Incremental stock-based compensation expense in connection with the termination of certain employees	$ 0.2	$ 0.2
Loss From Discontinued Operations [Member]
Significant Accounting Policies
Incremental stock-based compensation expense in connection with the termination of certain employees	$ 0.2	$ 0.2

NET LOSS PER SHARE - Computation of loss per Share (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Numerator:
Loss from continuing operations	$ (4,098,980)	$ (5,232,751)	$ (8,323,807)	$ (11,005,854)
Income (loss) from discontinued operations	6,614,769	(4,011,437)	5,872,020	(8,148,842)
Net income (loss)	$ 2,515,789	$ (9,244,188)	$ (2,451,787)	$ (19,154,696)
Denominator:
Weighted average common shares outstanding, Basic	8,798,956	8,359,205	8,760,209	8,335,119
Weighted average common shares outstanding, Diluted	8,798,956	8,359,205	8,760,209	8,335,119
Net loss per share, basic and diluted:
Loss from continuing operations, basic	$ (0.47)	$ (0.63)	$ (0.95)	$ (1.32)
Loss from continuing operations, diluted	(0.47)	(0.63)	(0.95)	(1.32)
Income (loss) from discontinued operations, basic	0.75	(0.48)	0.67	(0.98)
Income (loss) from discontinued operations, diluted	0.75	(0.48)	0.67	(0.98)
Net income (loss), basic	0.29	(1.11)	(0.28)	(2.30)
Net income (loss), diluted	$ 0.29	$ (1.11)	$ (0.28)	$ (2.30)

NET LOSS PER SHARE - Dilutive Securities (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
NET LOSS PER SHARE
Potentially dilutive securities	2,991,000	2,844,100	2,991,000	2,844,100
Common stock options
NET LOSS PER SHARE
Common stock options/purchase warrants	1,143,000	995,900	1,143,000	995,900
Common stock purchase warrants
NET LOSS PER SHARE
Common stock options/purchase warrants	1,848,000	1,848,200	1,848,000	1,848,200

DISCONTINUED OPERATIONS - Assets and liabilities (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
DISCONTINUED OPERATIONS
Total current assets of discontinued operations		$ 585,840
Total non-current assets of discontinued operations		17,802,929
Total current liabilities of discontinued operations	$ 260,280	5,260,616
Total non-current liabilities of discontinued operations		7,039,338
Disposed by sale
DISCONTINUED OPERATIONS
Prepaid expenses and other current assets		585,840
Total current assets of discontinued operations		585,840
Fixed Assets		12,323,143
Right of use assets		5,479,786
Total non-current assets of discontinued operations		17,802,929
Total assets of discontinued operations		18,388,769
Accounts payable	260,280	2,183,418
Related party deferred revenue		2,500,000
Short-term lease liabilities		577,198
Total current liabilities of discontinued operations	260,280	5,260,616
Long-term lease liabilities		7,039,338
Total non-current liabilities of discontinued operations		7,039,338
Total liabilities of discontinued operations	$ 260,280	$ 12,299,954

DISCONTINUED OPERATIONS - Operations (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
DISCONTINUED OPERATIONS
Loss from discontinued operations	$ 6,614,769	$ (4,011,437)	$ 5,872,020	$ (8,148,842)
Disposed by sale
DISCONTINUED OPERATIONS
Total revenues	816,641		4,316,641
Total operating expenses	2,996,297	4,011,437	7,239,048	8,148,842
Loss from discontinued operations	(2,179,657)	(4,011,437)	(2,922,406)	(8,148,842)
Disposed by sale \| Research and development
DISCONTINUED OPERATIONS
Total operating expenses	2,667,712	3,631,422	6,561,957	7,387,124
Disposed by sale \| General and administrative
DISCONTINUED OPERATIONS
Total operating expenses	328,585	$ 380,015	677,090	$ 761,719
Disposed by sale \| Service revenue
DISCONTINUED OPERATIONS
Total revenues	$ 816,641		816,641
Disposed by sale \| Related party service revenue
DISCONTINUED OPERATIONS
Total revenues			$ 3,500,000

DISCONTINUED OPERATIONS - Additional Information (Details) - USD ($)		1 Months Ended	3 Months Ended			6 Months Ended
	Jun. 26, 2023	Apr. 30, 2022	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
DISCONTINUED OPERATIONS
Gain on disposal of discontinued operations			$ 8,794,426			$ 8,794,426
Revenue recognized			762,658		$ 790,508	1,996,995	$ 1,754,830
Cell Ready Purchase Agreement
DISCONTINUED OPERATIONS
Consideration for purchased assets	$ 19,000,000.0
Service revenue \| Indapta
DISCONTINUED OPERATIONS
Revenue recognized			$ 800,000			$ 800,000
Related party service revenue \| Binding Services Agreement \| Wilson Wolf
DISCONTINUED OPERATIONS
Cash payment		$ 8,000,000.0		$ 8,000,000.0
Additional cash payment				1,000,000.0
Revenue recognized				2,500,000
Additional revenue recognized				$ 1,000,000.0
Disposed by sale \| Cell Ready Purchase Agreement
DISCONTINUED OPERATIONS
Consideration for purchased assets	19,000,000.0
Gain on disposal of discontinued operations	$ 8,800,000

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable	$ 1,330,000	$ 1,101,000
Compensation and benefits	610,000	750,000
Professional fees	525,000	518,000
Arbitration settlement fees		114,000
Other	196,000	38,000
Total accounts payable and accrued liabilities	$ 2,660,616	$ 2,521,193

STOCKHOLDERS' EQUITY - Reverse Stock Split and Common Stock Transactions (Details) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jan. 26, 2023	Dec. 31, 2022
STOCKHOLDERS' EQUITY
Common stock authorized	30,000,000			30,000,000
Proceeds from issuance of common stock, net	$ 619,974	$ 63,573
ATM Agreement
STOCKHOLDERS' EQUITY
Number of shares issued	200,261
Proceeds from issuance of common stock, net	$ 600,000
Minimum
STOCKHOLDERS' EQUITY
Common stock authorized			30,000,000
Maximum
STOCKHOLDERS' EQUITY
Common stock authorized			300,000,000

STOCKHOLDERS' EQUITY - Stock Purchase Agreement (Details) - USD ($)	1 Months Ended		3 Months Ended		6 Months Ended
	Jan. 31, 2023	Dec. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
STOCKHOLDERS' EQUITY
Aggregate proceeds from shares issued under the purchase agreement				$ 63,573	$ 619,974	$ 63,573
Proceeds from Issuance of Common Stock					619,974	$ 63,573
Issuance of common stock from exercise of stock options			$ 736		$ 736
Issuance of common stock from exercise of stock options (in shares)					344
Lincoln Park
STOCKHOLDERS' EQUITY
Commitment fee	$ 500,000
Stock Purchase Agreement \| Lincoln Park
STOCKHOLDERS' EQUITY
Aggregate proceeds from shares issued under the purchase agreement		$ 25,000,000
Issuance of common stock for cash (in shares)	180,410				12,500
Proceeds from Issuance of Common Stock					$ 33,000
Commitment fee	$ 500,000

STOCKHOLDERS' EQUITY - Share Purchase Warrants (Details) - $ / shares	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
WARRANTS
Number of Warrants, Beginning balance	1,848,000
Number of Warrants, Ending balance	1,848,000	1,848,000
Weighted Average Exercise Price, Beginning Balance	$ 44.51
Weighted Average Exercise Price, Ending Balance	$ 44.51	$ 44.51
Weighted Average Remaining Contractual Life (in years)	3 months 18 days	9 months 14 days

STOCK-BASED COMPENSATION - Stock option activity (Details) - USD ($)	3 Months Ended	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Jun. 30, 2023	Dec. 31, 2022
STOCK-BASED COMPENSATION
Exercised (Shares)		(344)
Common stock options
STOCK-BASED COMPENSATION
Number of Shares Outstanding, Beginning Balance		886,173
Granted (Shares)	544,532
Exercised (Shares)	(344)
Number of Shares, Cancelled / Expired	(287,803)
Number of Shares Outstanding, Ending Balance	1,142,558	1,142,558	886,173
Number of Shares, Options vested and exercisable	687,689	687,689
Weighted Average Exercise Price per Share Outstanding, Beginning Balance		$ 42.90
Weighted Average Exercise Price per Share, Granted	$ 1.99
Weighted Average Exercise Price per Share, Exercised	2.14
Weighted Average Exercise Price per Share, Cancelled / Expired	7.57
Weighted Average Exercise Price per Share Outstanding, Ending Balance	32.30	32.30	$ 42.90
Weighted Average Exercise Price, Options vested and exercisable	$ 50.53	$ 50.53
Total Intrinsic Value Outstanding	$ 455,000	$ 455,000
Total Intrinsic Value, Options vested and exercisable	$ 26,000	$ 26,000
Weighted Average Remaining Contractual Life, Outstanding	6 years 10 months 24 days		7 years 3 months 18 days
Weighted Average Remaining Contractual Life, Options granted	9 years 8 months 12 days
Weighted Average Remaining Contractual Life, Options vested and exercisable	5 years 3 months 18 days

STOCK-BASED COMPENSATION - Weighted average assumptions (Details)	6 Months Ended
	Jun. 30, 2023 $ / shares
STOCK-BASED COMPENSATION
Exercise price	$ 1.99
Expected term (years)	6 years
Expected stock price volatility	91.00%
Risk-free rate of interest	4.00%
Expected dividend rate	0.00%

STOCK-BASED COMPENSATION- Stock-based compensation expenses (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
STOCK-BASED COMPENSATION
Stock compensation in continuing operations	$ 169,000	$ 939,000	$ 540,000	$ 1,986,000
Stock compensation in discontinued operations	437,000	563,000	725,000	1,146,000
Total stock compensation expenses	606,000	1,502,000	1,265,000	3,132,000
Research and development
STOCK-BASED COMPENSATION
Total stock compensation expenses	42,000	200,000	193,000	398,000
General and administrative
STOCK-BASED COMPENSATION
Total stock compensation expenses	$ 127,000	$ 739,000	$ 347,000	$ 1,588,000

STOCK-BASED COMPENSATION - Additional Information (Details)						3 Months Ended	6 Months Ended
	Jun. 03, 2023 $ / shares	May 10, 2023 $ / shares shares	Apr. 03, 2023 installment $ / shares	Feb. 27, 2023 installment $ / shares shares	Jan. 03, 2023 installment $ / shares	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) $ / shares shares	Mar. 31, 2023 shares
STOCK-BASED COMPENSATION
Exercise price \| $ / shares						$ 1.99	$ 1.99
Compensation cost not yet recognized \| $						$ 1,000,000.0	$ 1,000,000.0
Compensation cost not yet recognized, period for recognition							1 year 10 months 24 days
Issuance of common stock from exercise of stock options (in shares) \| shares							344
Proceeds from exercise of stock options \| $							$ 736
Incremental stock-based compensation expense in connection with the termination of certain employees \| $						200,000	200,000
Loss from discontinued operations.
STOCK-BASED COMPENSATION
Incremental stock-based compensation expense in connection with the termination of certain employees \| $						$ 200,000	$ 200,000
2022 Equity Incentive Awards \| Employees
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares						1,000
Exercise price \| $ / shares			$ 0.7802
Number of options to purchase shares \| shares								7,000
Exercise price \| $ / shares					$ 2.769
Vesting percentage			0.25%		0.25%
2022 Equity Incentive Awards \| Employees \| Tranche one
STOCK-BASED COMPENSATION
Award vesting period			1 year		1 year
2022 Equity Incentive Awards \| Employees \| Tranche two
STOCK-BASED COMPENSATION
Number of equal monthly installments of award \| installment			36		36
Award vesting period			3 years		3 years
Vesting percentage			0.75%		0.75%
2022 Equity Incentive Awards \| Chief Executive Officer, President and Chairman \| Employees
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares		100,000
Exercise price \| $ / shares		$ 1.42
Award vesting period		10 years
2022 Equity Incentive Awards \| Director \| Non employee
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares						32,000
Exercise price \| $ / shares	$ 1.72
Award vesting period	1 year
2022 Equity Incentive Awards \| 2020 Equity Incentive Plan \| Executive officer
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares				316,855
Exercise price \| $ / shares				$ 2.14
Number of equal monthly installments of award \| installment				48
Award vesting period				4 years
2022 Equity Incentive Awards \| 2020 Equity Incentive Plan \| Non-executive employees
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares				87,677
Exercise price \| $ / shares				$ 2.14
Number of equal monthly installments of award \| installment				48
Award vesting period				4 years

GRANT INCOME (Details) - USD ($)	1 Months Ended		3 Months Ended		6 Months Ended
GRANT INCOME (Details) - USD ($)	Jul. 31, 2023	Aug. 31, 2021	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
GRANT INCOME
Receipt of product development research award		$ 13,100,000
Revenue recognized			$ 762,658	$ 790,508	$ 1,996,995	$ 1,754,830
Grant receivable								$ 2,000,000.0
Restricted cash recorded				0		0			$ 1,146,186
Grant income
GRANT INCOME
Revenue recognized			762,658	$ 790,508	1,996,995	$ 1,754,830
CPRIT grant
GRANT INCOME
Revenue recognized			700,000		1,800,000
Grant receivable			1,700,000		1,700,000
Restricted cash recorded			0		0		$ 0
FDA grant
GRANT INCOME
Revenue recognized			$ 100,000		$ 200,000
Grant receivable								$ 2,000,000.0
Subsequent event \| CPRIT grant
GRANT INCOME
Revenue recognized	$ 2,100,000

RELATED PARTY EXPENSES (Details) - USD ($)	3 Months Ended		6 Months Ended
RELATED PARTY EXPENSES (Details) - USD ($)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
RELATED PARTY EXPENSES
Total Research and development	$ 75,000	$ 331,000	$ 290,000	$ 1,344,000
Due to related party	0		0
Baylor College of Medicine
RELATED PARTY EXPENSES
Total Research and development	2,000	285,000	13,000	1,142,000
Bio-Techne Corporation
RELATED PARTY EXPENSES
Total Research and development				101,000
Wilson Wolf
RELATED PARTY EXPENSES
Total Research and development	$ 73,000	$ 46,000	$ 277,000	$ 101,000