0001410578-23-001217 | 10-Q | XBRL Viewer

For the Three Months Ended

March 31,

Other information:

Operating cash flows - operating leases

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STOCKHOLDERS' EQUITY (Tables)

3 Months Ended

Mar. 31, 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 - March 31, 2023	1,848,000	$	44.51	0.55	$	—

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

STOCKHOLDERS' EQUITY - Stock Purchase Agreement (Details) - USD ($)	1 Months Ended		3 Months Ended
	Jan. 31, 2023	Dec. 31, 2022	Mar. 31, 2023
STOCKHOLDERS' EQUITY
Aggregate proceeds from shares issued under the purchase agreement			$ 619,974
Proceeds from Issuance of Common Stock			$ 619,974
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

RELATED PARTY EXPENSES

3 Months Ended

Mar. 31, 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 months ended March 31, 2023 and 2022, respectively.


	For the Three Months Ended
	March 31,
	2023		2022
Baylor College of Medicine	$	11,000	$	856,000
Bio-Techne Corporation		—		101,000
Wilson Wolf Manufacturing Corporation		204,000		55,000
Total Research and development	$	215,000	$	1,012,000

$97,400 of related party transactions are included in accounts payable and accrued liabilities as of March 31, 2023.

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.

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.

SUBSEQUENT EVENTS	3 Months Ended
Mar. 31, 2023
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	NOTE 15: SUBSEQUENT EVENTS The Cell Ready Agreement In May 2023, the Company entered into a purchase agreement (the “Cell Ready Agreement”) with Cell Ready, LLC (“Cell Ready”), pursuant to which the Company will (i) assign to Cell Ready the leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sell to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assign to Cell Ready its rights, title and interest in the Company’s Master Services Agreement for Product Supply, 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”). Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready. Pursuant to the Cell Ready Agreement, Cell Ready will acquire the Purchased Assets for total consideration of approximately $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also intends to extend offers of employment to approximately 50 of the Company’s employees currently employed in its manufacturing, development, quality and regulatory affairs functions. The Cell Ready Agreement contains representations, warranties and covenants of the Company and Cell Ready that are customary for a transaction of this nature. The transaction is expected to close on June 26, 2023, subject to the satisfaction of customary closing conditions. Chief Executive Officer Change On April 27, 2023, the Board appointed Juan Vera as the Company’s President and Chief Executive Officer, effective Peter Hoang’s resignation effective May 1, 2023. There are no family relationships between Mr. Vera and any of the Company’s current or former directors or executive officers. The Company is party to a services agreement with AlloVir, Inc. (“AlloVir”), pursuant to which the Company provides AlloVir with development services. Mr. Vera serves on the board of directors of AlloVir. During the term of the services agreement, the Company and AlloVir may prepare work orders setting forth services to be provided by the Company. AlloVir has a $400,000 work order under the services agreement for long range process development and scale optimization services. The Company estimates that the severance costs related to the departure of Mr. Hoang will total approximately $0.4 million and will be recorded and paid in the second quarter of 2023.

SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2023

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 15: SUBSEQUENT EVENTS

The Cell Ready Agreement

In May 2023, the Company entered into a purchase agreement (the “Cell Ready Agreement”) with Cell Ready, LLC (“Cell Ready”), pursuant to which the Company will (i) assign to Cell Ready the leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sell to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assign to Cell Ready its rights, title and interest in the Company’s Master Services Agreement for Product Supply, 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”). Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready.

Pursuant to the Cell Ready Agreement, Cell Ready will acquire the Purchased Assets for total consideration of approximately $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also intends to extend offers of employment to approximately 50 of the Company’s employees currently employed in its manufacturing, development, quality and regulatory affairs functions.

The Cell Ready Agreement contains representations, warranties and covenants of the Company and Cell Ready that are customary for a transaction of this nature. The transaction is expected to close on June 26, 2023, subject to the satisfaction of customary closing conditions.

Chief Executive Officer Change

On April 27, 2023, the Board appointed Juan Vera as the Company’s President and Chief Executive Officer, effective Peter Hoang’s resignation effective May 1, 2023.

There are no family relationships between Mr. Vera and any of the Company’s current or former directors or executive officers. The Company is party to a services agreement with AlloVir, Inc. (“AlloVir”), pursuant to which the Company provides AlloVir with development services. Mr. Vera serves on the board of directors of AlloVir. During the term of the services agreement, the Company and AlloVir may prepare work orders setting forth services to be provided by the Company. AlloVir has a $400,000 work order under the services agreement for long range process development and scale optimization services.

The Company estimates that the severance costs related to the departure of Mr. Hoang will total approximately $0.4 million and will be recorded and paid in the second quarter of 2023.

RELATED PARTY EXPENSES (Tables)

3 Months Ended

Mar. 31, 2023

RELATED PARTY EXPENSES


	For the Three Months Ended
	March 31,
	2023		2022
Baylor College of Medicine	$	11,000	$	856,000
Bio-Techne Corporation		—		101,000
Wilson Wolf Manufacturing Corporation		204,000		55,000
Total Research and development	$	215,000	$	1,012,000

NET LOSS PER SHARE - Dilutive Securities (Details) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
NET LOSS PER SHARE
Potentially dilutive securities	3,145,000	2,921,900
Common stock options
NET LOSS PER SHARE
Common stock purchase warrants	1,297,000	938,900
Common stock purchase warrants
NET LOSS PER SHARE
Common stock purchase warrants	1,848,000	1,983,000

NET LOSS PER SHARE - Computation of loss per Share (Details) - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Numerator:
Net loss	$ (4,967,576)	$ (9,910,508)
Denominator:
Weighted average common shares outstanding, Basic	8,721,031	8,310,765
Weighted average common shares outstanding, Diluted	8,721,031	8,310,765
Net loss per share:
Net loss per share, basic	$ (0.57)	$ (1.19)
Net loss per share, diluted	$ (0.57)	$ (1.19)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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+ Details

PROPERTY AND EQUIPMENT (Tables)

3 Months Ended

Mar. 31, 2023

PROPERTY AND EQUIPMENT

Schedule of property and equipment


		March 31,		December 31,
	Estimated Useful Lives	2023		2022
Lab and manufacturing equipment	5 Years	$	12,020,000	$	11,824,000
Computers, equipment and software	3-5 Years		900,000		899,000
Office furniture	5 Years		924,000		924,000
Leasehold improvements	Lesser of lease term or estimated useful life		3,950,000		3,950,000
Total			17,794,000		17,597,000
Less: accumulated depreciation			(6,092,000)		(5,274,000)
Total fixed assets, net		$	11,702,000	$	12,323,000

STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Common stock options - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
STOCK-BASED COMPENSATION
Number of Shares Outstanding, Beginning Balance	886,173
Granted (Shares)	411,532
Number of Shares, Cancelled / Expired	(1,000)
Number of Shares Outstanding, Ending Balance	1,296,705	886,173
Number of Shares, Options vested and exercisable	604,335
Weighted Average Exercise Price per Share Outstanding, Beginning Balance	$ 42.90
Weighted Average Exercise Price per Share, Granted	2.15
Weighted Average Exercise Price per Share Outstanding, Ending Balance	29.98	$ 42.90
Weighted Average Exercise Price, Options vested and exercisable	$ 56.39
Weighted Average Remaining Contractual Life, Outstanding	8 years	7 years 3 months 18 days
Weighted Average Remaining Contractual Life, Options granted	9 years 10 months 24 days
Weighted Average Remaining Contractual Life, Options vested and exercisable	6 years 6 months

STOCK BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2023

STOCK-BASED COMPENSATION

Summary 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	411,532		2.15		—	9.9
Canceled/Expired	(1,000)		—		—	—
Outstanding as of March 31, 2023	1,296,705	$	29.98	$	—	8.0
Options vested and exercisable	604,335	$	56.39	$	—	6.5

Schedule or description of weighted average discount rate


	For the Three Months Ended
	March 31, 2023
Exercise price	$	2.15
Expected term (years)		6.0
Expected stock price volatility		90	%
Risk-free rate of interest		4	%
Expected dividend rate		0	%

Schedule of stock-based compensation expenses


	For the Three Months Ended
	March 31,
	2023		2022
Stock Compensation expenses:
Research and development	$	408,000	$	878,000
General and administrative		252,000		753,000
Total stock compensation expenses	$	660,000	$	1,631,000

RELATED PARTY RECEIVABLE AND RELATED PARTY DEFERRED REVENUE (Details) - USD ($)		1 Months Ended	3 Months Ended
	May 15, 2023	Apr. 30, 2022	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
RELATED PARTY LIABILITY
Revenue recognized			$ 4,734,336	$ 964,322
Related party receivable			1,000,000
Related party deferred revenue					$ 2,500,000
Wilson Wolf Manufacturing Corporation \| Binding Services Agreement
RELATED PARTY LIABILITY
Cash payment from related party		$ 8,000,000.0
Advance received for non-exclusive training of Wilson Wolf to make, use, and sell Marker's cell culture non-proprietary media formulation		2,000,000.0
Advance received for non-exclusive training of Wilson Wolf to replicate Marker's quality management system inclusive of all underlying documents		1,000,000.0
Advance received for non-exclusive training of Wilson Wolf to replicate Marker's cGMP-compliant, linearly scalable, G-Rex based T-cell manufacturing process		2,000,000.0
Advance received under the hired to invent doctrine for Marker to train Wilson Wolf on its expertise in the optimization of T-cell therapy manufacturing processes		$ 3,000,000.0
Period for completion of optimization work under the direction of Wilson Wolf which Marker will make good faith efforts from the agreement date		18 months
Additional amount agreed to received from Wilson Wolf if the Work Direction is completed within one year from the onset of the agreement		$ 1,000,000.0
Revenue recognized			2,500,000
Revenue from service fee recorded			1,000,000.0
Revenue receivable from achievement of the agreed milestone of completing the service			1,000,000.0
Related party receivable			$ 1,000,000.0
Wilson Wolf Manufacturing Corporation \| Binding Services Agreement \| Subsequent event
RELATED PARTY LIABILITY
Payment received	$ 1,000,000.0

LEASES (Details) - USD ($)	Mar. 31, 2023	Dec. 31, 2022
LEASES
Total operating lease liabilities	$ 7,489,000
Operating lease, right-of-use asset	$ 5,326,268	$ 5,479,786

STOCK-BASED COMPENSATION

3 Months Ended

Mar. 31, 2023

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

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, 2022, 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.

A summary of the Company’s stock option activity for the three months ended March 31, 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	411,532		2.15		—	9.9
Canceled/Expired	(1,000)		—		—	—
Outstanding as of March 31, 2023	1,296,705	$	29.98	$	—	8.0
Options vested and exercisable	604,335	$	56.39	$	—	6.5

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 three months ended March 31, 2023 was as follows:


	For the Three Months Ended
	March 31, 2023
Exercise price	$	2.15
Expected term (years)		6.0
Expected stock price volatility		90	%
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
	March 31,
	2023		2022
Stock Compensation expenses:
Research and development	$	408,000	$	878,000
General and administrative		252,000		753,000
Total stock compensation expenses	$	660,000	$	1,631,000

As of March 31, 2023, the total stock-based compensation cost related to unvested awards not yet recognized was $3.5 million. The expected weighted average period compensation costs to be recognized was approximately 2.0 years. Future option grants will impact the compensation expense recognized.

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Mar. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 6,401,243	$ 11,782,172
Prepaid expenses and deposits	2,428,743	2,435,079
Related party receivable	1,000,000
Other receivables	1,082,886	2,402,004
Total current assets	10,912,872	16,619,255
Non-current assets:
Property, plant and equipment, net	11,701,907	12,323,143
Right-of-use assets, net	5,326,268	5,479,786
Total non-current assets	17,028,175	17,802,929
Total assets	27,941,047	34,422,184
Current liabilities:
Accounts payable and accrued liabilities	4,538,966	4,704,611
Related party deferred revenue		2,500,000
Lease liability	665,082	577,198
Total current liabilities	5,204,048	7,781,809
Non-current liabilities:
Lease liability, net of current portion	6,823,651	7,039,338
Total non-current liabilities	6,823,651	7,039,338
Total liabilities	12,027,699	14,821,147
Stockholders' equity:
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at March 31, 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 March 31, 2023 and December 31, 2022, respectively	8,799	8,406
Additional paid-in capital	448,921,174	447,641,680
Accumulated deficit	(433,016,625)	(428,049,049)
Total stockholders' equity	15,913,348	19,601,037
Total liabilities and stockholders' equity	$ 27,941,047	$ 34,422,184

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2023

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

Schedule of accounts payable and accrued liabilities


	March 31,		December 31,
	2023		2022
Accounts payable	$	2,863,000	$	1,612,000
Compensation and benefits		454,000		1,779,000
Process development expenses		329,000		342,000
Professional fees		598,000		558,000
Arbitration settlement fees		—		114,000
Other		295,000		300,000
Total accounts payable and accrued liabilities	$	4,539,000	$	4,705,000

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
Stock-based compensation	$ 37	1,630,640		1,630,677
Stock-based compensation (in shares)	37,251
Net loss			(9,910,508)	(9,910,508)
Ending Balance at Mar. 31, 2022	$ 8,345	443,726,282	(408,028,863)	35,705,764
Ending Balance, Shares at Mar. 31, 2022	8,345,119
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 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	659,913	0	659,913
Stock-based compensation (in shares)	0
Net loss			(4,967,576)	(4,967,576)
Fractional shares adjustment due to reverse split	(113)
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

BASIS OF PRESENTATION

3 Months Ended

Mar. 31, 2023

BASIS OF PRESENTATION

BASIS OF PRESENTATION

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.

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 March 31, 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.

LEASES - Quantitative Information About Operating Leases (Details) - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Operating lease expense summary:
Operating lease expense	$ 258,000	$ 425,000
Short-term lease expense	26,000	3,000
Variable lease expense	109,000	179,000
Total	393,000	607,000
Other information:
Operating cash flows - operating leases	$ 232,000	$ 316,000
Weighted-average remaining lease term - operating leases	7 years 3 months 18 days		7 years 6 months
Weighted-average discount rate used to determine the operating lease liability	5.50%		5.50%

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	May 08, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 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	4551 Kennedy Commerce Drive
Entity Address, City or Town	Houston
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77032
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		8,798,829
Entity Central Index Key	0001094038
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Amendment Flag	false

STOCK-BASED COMPENSATION- Stock-based compensation expenses (Details) - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
STOCK-BASED COMPENSATION
Total stock compensation expenses	$ 660,000	$ 1,631,000
Research and development
STOCK-BASED COMPENSATION
Total stock compensation expenses	408,000	878,000
General and administrative
STOCK-BASED COMPENSATION
Total stock compensation expenses	$ 252,000	$ 753,000

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

3 Months Ended

Mar. 31, 2023

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

NOTE 8: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

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


	March 31,		December 31,
	2023		2022
Accounts payable	$	2,863,000	$	1,612,000
Compensation and benefits		454,000		1,779,000
Process development expenses		329,000		342,000
Professional fees		598,000		558,000
Arbitration settlement fees		—		114,000
Other		295,000		300,000
Total accounts payable and accrued liabilities	$	4,539,000	$	4,705,000

RELATED PARTY RECEIVABLE AND RELATED PARTY DEFERRED REVENUE

3 Months Ended

Mar. 31, 2023

NOTE 9: RELATED PARTY RECEIVABLE AND RELATED PARTY DEFERRED REVENUE

In April 2022, the Company entered into a binding services agreement, effective April 12, 2022, 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 Services 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 allocated as follows:

●

$2.0 million for non-exclusive training of Wilson Wolf to make, use, and sell the Company’s cell culture non-proprietary media formulation that has been cleared in an FDA investigational new drug application;

●

$1.0 million for non-exclusive training of Wilson Wolf to replicate the Company’s quality management system inclusive of all underlying documents related thereto, none of which shall include unique information specific to the manufacture of the Company’s multiTAA product candidates such as direct peptide stimulation;

●

$2.0 million for non-exclusive training of Wilson Wolf to be able to replicate the Company’s cGMP-compliant, linearly scalable, G-Rex based T-cell manufacturing process which Wilson Wolf shall use as it sees fit in pursuit of the Wilson Wolf Mission; and

●

$3.0 million for the Company to train Wilson Wolf on its expertise in the optimization of T-cell therapy manufacturing processes using G-Rex and to conduct CAR T and TCR G-Rex Optimization Work under the direction of Wilson Wolf (the “Work Direction”), whereunder all intellectual property provided by Wilson Wolf or created or derived by the Company will be solely owned by Wilson Wolf, and whereby the Company will make good faith efforts to complete the conduct of such work as soon as practicable within 18 months from the date of the agreement. Wilson Wolf has agreed to pay the Company an additional $1.0 million if the Work Direction is completed within one year from the onset of the Agreement.

The Company recognizes related party revenue over time in accordance with Accounting Standard Codification, or ASC, 606 Revenue from Contracts with Customers, as each of the training and/or research services are provided to Wilson Wolf. Revenue is recognized, using an output method based on progress toward satisfaction of the performance obligations. Additionally, in accordance with the spirit of the standard expressed in ASC 606-50-1, the timing of the revenue recognition is expected to be approximately 12 months.

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 March 31, 2023, the Company had no related party deferred revenue on its condensed consolidated balance sheet.

Additionally, pursuant to the 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 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, with a corresponding $1.0 million related party receivable on its condensed consolidated balance sheet as of March 31, 2023. The Company received the $1.0 million payment in May 2023.

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 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

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2023

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 4: SIGNIFICANT ACCOUNTING POLICIES

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.

LEASES

3 Months Ended

Mar. 31, 2023

LEASES

LEASES

NOTE 7: LEASES

The Company leases manufacturing, research and administrative facilities under operating leases. The Company evaluates its contracts to determine if an arrangement is a lease at inception and classify it as a finance or operating lease. Currently, all of the Company’s leases are classified as operating leases. Leased assets and corresponding liabilities are recognized based on the present value of the lease payments over the lease term. The lease terms may include options to extend when it is reasonably certain that the Company will exercise that option.

Topic ASC 842 requires the Company to recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. Right-of-use assets are recorded in other assets on the Company’s condensed consolidated balance sheets. Current and non-current lease liabilities are recorded in other accruals within current liabilities and other non-current liabilities, respectively, on its condensed consolidated balance sheets. Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease.

As of March 31, 2023, the Company had total operating lease liabilities of approximately $7.5 million and right-of-use assets of approximately $5.3 million, which were included in the condensed consolidated balance sheet.

Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Variable expenses generally represent the Company’s share of the landlord’s operating expenses. The Company does not act as a lessor or have any leases classified as financing leases.

The following summarizes quantitative information about the Company’s operating leases for the three months ended March 31, 2023 and 2022, respectively:


	For the Three Months Ended
	March 31,
	2023		2022
Operating lease expense summary:
Operating lease expense		258,000		425,000
Short-term lease expense		26,000		3,000
Variable lease expense		109,000		179,000
Total	$	393,000	$	607,000

The weighted-average remaining lease term as of March 31, 2023 and December 31, 2022 was approximately 7.3 years and 7.5 years, respectively. The weighted-average discount rate used to determine the operating lease liability as of March 31, 2023 and December 31, 2022 was approximately 5.5%, respectively.

Maturities of our operating leases, excluding short-term leases, are as follows:


Nine months ending December 31, 2023		751,000
Year ending December 31, 2024		1,254,000
Year ending December 31, 2025		1,290,000
Year ending December 31, 2026		1,177,000
Year ending December 31, 2027		1,163,000
Thereafter		3,590,000
Total		9,225,000
Less present value discount		(1,736,000)
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023	$	7,489,000

STOCKHOLDERS' EQUITY - Share Purchase Warrants (Details) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 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)	6 months 18 days	9 months 14 days

RELATED PARTY EXPENSES (Details) - USD ($)	3 Months Ended
RELATED PARTY EXPENSES (Details) - USD ($)	Mar. 31, 2023	Mar. 31, 2022
RELATED PARTY EXPENSES
Total Research and development	$ 215,000	$ 1,012,000
Due to related party	97,400
Baylor College of Medicine
RELATED PARTY EXPENSES
Total Research and development	11,000	856,000
Bio-Techne Corporation
RELATED PARTY EXPENSES
Total Research and development		101,000
Wilson Wolf Manufacturing Corporation
RELATED PARTY EXPENSES
Total Research and development	$ 204,000	$ 55,000

- Definition

Carrying amount as of the balance sheet date of obligations due all related parties.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(k)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(C))
-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442552-122756

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
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-Subparagraph (SX 210.13-02(a)(5))
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 210
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03.17)
-URI https://asc.fasb.org/extlink&oid=126734703&loc=d3e572229-122910

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
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-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(iv))
-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442526-122756

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(iii)(B))
-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442526-122756

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 210
-Section S99
-Paragraph 1
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 850
-SubTopic 10
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-Paragraph 1
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=6457730&loc=d3e39549-107864

+ Details

PROPERTY AND EQUIPMENT - Additional Information (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
PROPERTY AND EQUIPMENT
Depreciation expense	$ 800,000	$ 600,000
Property, plant and equipment, net	11,702,000	$ 12,323,000
Accounts Payable and Accrued Liabilities
PROPERTY AND EQUIPMENT
Property, plant and equipment, net	$ 142,000

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

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Mar. 31, 2023	Dec. 31, 2022
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable	$ 2,863,000	$ 1,612,000
Compensation and benefits	454,000	1,779,000
Process development expenses	329,000	342,000
Professional fees	598,000	558,000
Arbitration settlement fees		114,000
Other	295,000	300,000
Total accounts payable and accrued liabilities	$ 4,538,966	$ 4,704,611

PROPERTY AND EQUIPMENT

3 Months Ended

Mar. 31, 2023

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

NOTE 6: PROPERTY AND EQUIPMENT

Property and equipment consist of the following as of March 31, 2023 and December 31, 2022, respectively:


		March 31,		December 31,
	Estimated Useful Lives	2023		2022
Lab and manufacturing equipment	5 Years	$	12,020,000	$	11,824,000
Computers, equipment and software	3-5 Years		900,000		899,000
Office furniture	5 Years		924,000		924,000
Leasehold improvements	Lesser of lease term or estimated useful life		3,950,000		3,950,000
Total			17,794,000		17,597,000
Less: accumulated depreciation			(6,092,000)		(5,274,000)
Total fixed assets, net		$	11,702,000	$	12,323,000

Depreciation expense for the three months ended March 31, 2023 and 2022 was approximately $0.8 million and $0.6 million, respectively.

$142,000 of property and equipment transactions are included in accounts payable and accrued liabilities as of March 31, 2023.

SUBSEQUENT EVENTS (Details) - Subsequent event		1 Months Ended
SUBSEQUENT EVENTS (Details) - Subsequent event	Apr. 27, 2023 USD ($)	May 31, 2023 USD ($) lease employee	Jun. 30, 2023 USD ($)
Cell Ready Agreement
Subsequent Events
Number of leased manufacturing facilities assigned \| lease		2
Consideration		$ 19,000,000.0
Offers employment to number of employees \| employee		50
AlloVir, Inc
Subsequent Events
Value of work order under the services agreement	$ 400,000
Severance costs related to the departure			$ 400,000

LEASES (Tables)

3 Months Ended

Mar. 31, 2023

LEASES

Schedule of quantitative information about operating leases


	For the Three Months Ended
	March 31,
	2023		2022
Operating lease expense summary:
Operating lease expense		258,000		425,000
Short-term lease expense		26,000		3,000
Variable lease expense		109,000		179,000
Total	$	393,000	$	607,000

Schedule of maturities of operating leases


Nine months ending December 31, 2023		751,000
Year ending December 31, 2024		1,254,000
Year ending December 31, 2025		1,290,000
Year ending December 31, 2026		1,177,000
Year ending December 31, 2027		1,163,000
Thereafter		3,590,000
Total		9,225,000
Less present value discount		(1,736,000)
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023	$	7,489,000

STOCK-BASED COMPENSATION - Additional Information (Details) $ / shares in Units, $ in Millions			3 Months Ended
	Feb. 27, 2023 installment $ / shares shares	Jan. 03, 2022	Mar. 31, 2023 USD ($) installment $ / shares shares
STOCK-BASED COMPENSATION
Exercise price			$ 2.15
Compensation cost not yet recognized \| $			$ 3.5
Compensation cost not yet recognized, period for recognition			2 years
2022 Equity Incentive Awards \| Employees
STOCK-BASED COMPENSATION
Number of options to purchase shares \| shares			7,000
Exercise price			$ 2.769
Vesting percentage		25.00%
2022 Equity Incentive Awards \| Employees \| Tranche one
STOCK-BASED COMPENSATION
Award vesting period			1 year
2022 Equity Incentive Awards \| Employees \| Tranche two
STOCK-BASED COMPENSATION
Number of equal monthly installments of award \| installment			36
Award vesting period			3 years
Vesting percentage			75.00%
2022 Equity Incentive Awards \| 2020 Equity Incentive Plan \| Executive officer
STOCK-BASED COMPENSATION
Number of Shares, Granted \| shares	316,855
Exercise price	$ 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	$ 2.14
Number of equal monthly installments of award \| installment	48
Award vesting period	4 years

LEASES - Maturities of Operating Leases (Details)	Mar. 31, 2023 USD ($)
LEASES
Nine months ending December 31, 2023	$ 751,000
Year ending December 31, 2024	1,254,000
Year ending December 31, 2025	1,290,000
Year ending December 31, 2026	1,177,000
Year ending December 31, 2027	1,163,000
Thereafter	3,590,000
Total	9,225,000
Less present value discount	(1,736,000)
Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2023	$ 7,489,000

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Revenues:
Total revenues	$ 4,734,336	$ 964,322
Operating expenses:
Research and development	7,270,742	7,026,066
General and administrative	2,515,824	3,733,001
Total operating expenses	9,786,566	10,759,067
Loss from operations	(5,052,230)	(9,794,745)
Other income (expenses):
Arbitration settlement		(118,880)
Interest income	84,654	3,117
Net loss	$ (4,967,576)	$ (9,910,508)
Net loss per share, basic	$ (0.57)	$ (1.19)
Net loss per share, diluted	$ (0.57)	$ (1.19)
Weighted average number of common shares outstanding, basic	8,721,031	8,310,765
Weighted average number of common shares outstanding, diluted	8,721,031	8,310,765
Grant income
Revenues:
Total revenues	$ 1,234,336	$ 964,322
Related partry service revenue
Revenues:
Total revenues	$ 3,500,000

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2023

SIGNIFICANT ACCOUNTING POLICIES

New Accounting Standards

GRANT INCOME (Details) - USD ($)	1 Months Ended	3 Months Ended
GRANT INCOME (Details) - USD ($)	Aug. 31, 2021	Mar. 31, 2023	Mar. 31, 2022
GRANT INCOME
Receipt of product development research award	$ 13,100,000
Revenue recognized		$ 4,734,336	$ 964,322
FDA's orphan products grant program, grant receivable		2,000,000.0
Grant income
GRANT INCOME
Revenue recognized		1,234,336	$ 964,322
CPRIT grant
GRANT INCOME
Revenue recognized		$ 1,200,000

- Definition

Amount, including tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value-added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-SubTopic 10
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-Paragraph 32
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130543-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-SubTopic 10
-Section 50
-Paragraph 42
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9031-108599

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
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-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI https://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

LIQUIDITY, GOING CONCERN AND FINANCIAL CONDITION

3 Months Ended

Mar. 31, 2023

LIQUIDITY, GOING CONCERN AND FINANCIAL CONDITION

LIQUIDITY, GOING CONCERN AND FINANCIAL CONDITION

NOTE 3: LIQUIDITY, GOING CONCERN AND FINANCIAL CONDITION

As of March 31, 2023, the Company had cash and cash equivalents of approximately $6.4 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 three months ended March 31, 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 $4.8 million of funds from the CPRIT grant. The Company recorded $1.1 million of grant income related to the CPRIT grant as revenue for the three months ended March 31, 2023.

In April 2022, the Company entered into a binding services agreement (the “Agreement”), effective April 12, 2022 (see Note 9), 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, therefore Wilson Wolf is a related party. 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 Agreement, Wilson Wolf made a cash payment to the Company in the amount of $8.0 million. For the three-month period ending March 31, 2023, the Company recognized the final $2.5 million of revenue pursuant to this Agreement. Additionally, pursuant to the Agreement, Wilson Wolf agreed to pay the Company an additional $1.0 million because the Company achieved the agreed milestone of completing the services within one year from the onset of the Agreement. As such, the Company recorded an additional $1.0 million of service fee revenue during the three months ended March 31, 2023, with a corresponding $1.0 million related party receivable on its condensed consolidated balance sheet as of March 31, 2023. The Company received the $1.0 million payment in May 2023.

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 of grant income related to the FDA grant as revenue for the three months ended March 31, 2023.

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. in which Marker will provide services for AlloVir’s long range process development and scale optimization. Under the terms of this agreement, Marker will receive total compensation in the amount of $0.4 million, estimated to be fully earned by the end of quarter ended September 30, 2023. As of March 31, 2023, the Company did not receive any funds from the Allovir agreement. The Company anticipates that the Allovir agreement will be a Purchased Asset under the Cell Ready Agreement.

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”). 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 Agreement, Cell Ready will acquire the Purchased Assets for total consideration of approximately $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also intends to extend offers of employment to approximately 50 of the Company’s employees currently employed in its manufacturing, development, quality and regulatory affairs functions. The Cell Ready Agreement contains representations, warranties and covenants of the Company and Cell Ready that are customary for a transaction of this nature. The transaction is expected to close on June 26, 2023, subject to the satisfaction of customary closing conditions.

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 March 31, 2023 will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2023. Such estimate does not include receipt of the approximately $19.0 million in connection with the closing of the Cell Ready Agreement, which is expected on June 26, 2023, subject to the satisfaction of customary closing conditions, and related anticipated cost savings. In an effort to further preserve the Company’s working capital, the Company’s employees took a portion of their 2022 earned bonus in the form of equity in lieu of cash.

The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it:

●

initiates or continues clinical trials of its product candidates;

●

continues the research and development of its product candidates and seeks to discover additional product candidates;

●

seeks regulatory approvals for any product candidates that successfully complete clinical trials;

●

maintains and enforces intellectual property rights;

●

establishes sales, marketing and distribution infrastructure and 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 planned business activities is dependent upon its successful efforts to raise additional capital.

These factors raise substantial doubt regarding its ability to continue as a going concern. The Company’s condensed consolidated financial statements have been prepared on a going concern basis, which implies that it will continue to realize its assets and discharge its liabilities in the normal course of business. The Company’s financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should it be unable to continue as a going concern.

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.

GRANT INCOME

3 Months Ended

Mar. 31, 2023

GRANT INCOME

GRANT INCOME

NOTE 12: GRANT INCOME

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.

Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.

The Company recorded $1.2 million of grant income related to the CPRIT grant as revenue for the three months ended March 31, 2023.

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 $1.2 million of grant income related to the FDA grant as revenue for the three months ended March 31, 2023.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
-Section 50
-Paragraph 9
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 12
-Subparagraph (e)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

+ Details

NET LOSS PER SHARE

3 Months Ended

Mar. 31, 2023

NET LOSS PER SHARE

NET LOSS PER SHARE

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 months ended March 31, 2023 and 2022, respectively:


	For the Three Months Ended
	March 31,
	2023		2022
Numerator:
Net loss	$	(4,967,576)	$	(9,910,508)

Denominator:
Weighted average common shares outstanding		8,721,031		8,310,765

Net loss per share:
Basic and diluted	$	(0.57)	$	(1.19)

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 Months Ended
	March 31,
	2023	2022
Common stock options	1,297,000	938,900
Common stock purchase warrants	1,848,000	1,983,000
Potentially dilutive securities	3,145,000	2,921,900

LIQUIDITY, GOING CONCERN AND FINANCIAL CONDITION (Details)				1 Months Ended		3 Months Ended			12 Months Ended
	May 15, 2023 USD ($)	Apr. 21, 2022 USD ($)	Aug. 31, 2021 USD ($)	May 31, 2023 USD ($) lease employee	Jan. 31, 2023 USD ($) shares	Sep. 30, 2023 USD ($)	Mar. 31, 2023 USD ($) shares	Mar. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Cash and cash equivalents							$ 6,401,243		$ 11,782,172
Proceeds from issuance of common stock, net							619,974
Amount of notice received			$ 13,100,000
Funds received from CPRIT grant							4,800,000
Related party receivable							1,000,000
Revenue recognized							4,734,336	$ 964,322
FDA's orphan products grant program, grant receivable							2,000,000.0
Total compensation amount							659,913	1,630,677
Issuance of common stock for cash							619,974
Research and development including capital expenditure cost							$ 19,000,000.0
Common Stock
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Number of shares issued \| shares							212,761
Issuance of common stock for cash							$ 213
Related partry service revenue
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Revenue recognized							3,500,000
Grant income
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Revenue from CPRIT							1,100,000
Revenue recognized							1,234,336	$ 964,322
FDA grant
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Revenue recognized							$ 100,000
FDA's orphan products grant program, grant receivable										$ 2,000,000.0
Lincoln Park
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Commitment fee					$ 500,000
Lincoln Park \| Common Stock
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
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
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Total compensation amount						$ 400,000
ATM Agreement
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Aggregate offering price			75,000,000.0
ATM Agreement \| Sales Agents
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
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
Binding Services Agreement \| Wilson Wolf Manufacturing Corporation
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Total amount of cash received from Wilson Wolf		$ 8,000,000.0					2,500,000
Revenue receivable from achievement of the agreed milestone of completing the service							1,000,000.0
Revenue from service fee recorded							1,000,000.0
Related party receivable							1,000,000.0
Revenue recognized							$ 2,500,000
Binding Services Agreement \| Subsequent event \| Wilson Wolf Manufacturing Corporation
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Payment received	$ 1,000,000.0
Cell Ready Agreement \| Subsequent event
FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
Number of leased manufacturing facilities assigned \| lease				2
Consideration				$ 19,000,000.0
Offers employment to number of employees \| employee				50

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash Flows from Operating Activities:
Net loss	$ (4,967,576)	$ (9,910,508)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization	818,216	576,331
Stock-based compensation	659,913	1,630,677
Amortization on right-of-use assets	153,518	257,889
Changes in operating assets and liabilities:
Prepaid expenses and deposits	6,336	288,409
Related party receivable	(1,000,000)
Other receivables	1,319,118	(1,948)
Accounts payable and accrued expenses	(250,017)	(3,953,976)
Related party deferred revenue	(2,500,000)
Deferred revenue		(964,322)
Lease liability	(127,803)	(148,614)
Net cash used in operating activities	(5,888,295)	(12,226,062)
Cash Flows from Investing Activities:
Purchase of property and equipment	(112,608)	(826,583)
Purchase of construction in progress		(1,625,605)
Net cash used in investing activities	(112,608)	(2,452,188)
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net	619,974
Net cash provided by financing activities	619,974
Net decrease in cash and cash equivalents	(5,380,929)	(14,678,250)
Cash and cash equivalents at beginning of the period	11,782,172	43,497,331
Cash and cash equivalents at end of the period	6,401,243	28,819,081
Supplemental schedule of non-cash financing and investing activities:
Capital expenditures included in accounts payable	141,979	$ 2,328,499
Issuance of common stock as commitment fee for future financing	$ 180

NATURE OF OPERATIONS (Details) - USD ($)	Jan. 26, 2023	Mar. 31, 2023	Dec. 31, 2022
NATURE OF OPERATIONS
Reverse stock split	1-for-10
Common stock authorized		30,000,000	30,000,000
Reverse stock split value	$ 394.80
Maximum
NATURE OF OPERATIONS
Common stock authorized	300,000,000
Minimum
NATURE OF OPERATIONS
Common stock authorized	30,000,000

LEGAL PROCEEDINGS

3 Months Ended

Mar. 31, 2023

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS

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.

NATURE OF OPERATIONS

3 Months Ended

Mar. 31, 2023

NATURE OF OPERATIONS

NATURE OF OPERATIONS

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.

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.

STOCK-BASED COMPENSATION - Weighted Average Assumptions (Details)	3 Months Ended
	Mar. 31, 2023 $ / shares
STOCK-BASED COMPENSATION
Exercise price	$ 2.15
Expected term (years)	6 years
Expected stock price volatility	90.00%
Risk-free rate of interest	4.00%
Expected dividend rate	0.00%

STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2023

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

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 three months ended March 31, 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 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.

Share Purchase Warrants

A summary of the Company’s share purchase warrants as of March 31, 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 - March 31, 2023	1,848,000	$	44.51	0.55	$	—

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-Paragraph 13
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

PROPERTY AND EQUIPMENT (Details) - USD ($)	3 Months Ended
PROPERTY AND EQUIPMENT (Details) - USD ($)	Mar. 31, 2023	Dec. 31, 2022
PROPERTY AND EQUIPMENT
Total	$ 17,794,000	$ 17,597,000
Less: accumulated depreciation	(6,092,000)	(5,274,000)
Total fixed assets, net	11,702,000	12,323,000
Lab and manufacturing equipment
PROPERTY AND EQUIPMENT
Total	$ 12,020,000	11,824,000
Estimated Useful Lives	5 years
Computers, equipment and software
PROPERTY AND EQUIPMENT
Total	$ 900,000	899,000
Computers, equipment and software \| Minimum
PROPERTY AND EQUIPMENT
Estimated Useful Lives	3 years
Computers, equipment and software \| Maximum
PROPERTY AND EQUIPMENT
Estimated Useful Lives	5 years
Office furniture
PROPERTY AND EQUIPMENT
Total	$ 924,000	924,000
Estimated Useful Lives	5 years
Leasehold improvements
PROPERTY AND EQUIPMENT
Total	$ 3,950,000	$ 3,950,000

NET LOSS PER SHARE (Tables)

3 Months Ended

Mar. 31, 2023

NET LOSS PER SHARE

Schedule of computation of net loss per share


	For the Three Months Ended
	March 31,
	2023		2022
Numerator:
Net loss	$	(4,967,576)	$	(9,910,508)

Denominator:
Weighted average common shares outstanding		8,721,031		8,310,765

Net loss per share:
Basic and diluted	$	(0.57)	$	(1.19)

Schedule of anti-dilutive securities


	For the Three Months Ended
	March 31,
	2023	2022
Common stock options	1,297,000	938,900
Common stock purchase warrants	1,848,000	1,983,000
Potentially dilutive securities	3,145,000	2,921,900

STOCKHOLDERS' EQUITY - Reverse Stock Split and Common Stock Transactions (Details) - USD ($)	3 Months Ended
	Mar. 31, 2023	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
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