0001558370-23-014901 | 10-Q | XBRL Viewer

Print Document View Excel Document

NET LOSS PER SHARE OF COMMON STOCK - Dilutive Securities Excluded From the Computations of Earnings Per Share (Details)	3 Months Ended
	Jun. 30, 2023 shares
Restricted Stock Units
Dilutive Securities Excluded From the Computations of Earnings Per Share
Potentially dilutive securities	23,936
Warrants
Dilutive Securities Excluded From the Computations of Earnings Per Share
Potentially dilutive securities	15,416

LEASES

6 Months Ended

Jun. 30, 2023

Leases

LEASES

8.LEASES

The Company adopted FASB ASU No. 2016-02, Leases (Topic 842) on January 1, 2022, using the modified retrospective method, in which it did not restate prior periods. Upon adoption, the Company elected the package of practical expedients permitted under the transition guidance within Topic 842 which, among other things, allowed the Company to carry forward the historical lease classification.

In our implementation of ASU No. 2016-02 the Company elected to discount lease obligations using our incremental borrowing rate, which is derived from information available at the lease commencement date, in determining the present value of lease payments. The Company’s incremental borrowing rate represents the rate of interest that it would have to pay to borrow over a similar term an amount equal to the lease payments in a similar economic environment. The Company considers publicly available data for instruments with similar terms and characteristics when determining its incremental borrowing rates. In addition, we elected the practical expedient to account for the lease and non-lease components on a combined basis. The Company intends to use the full lease term under the existing lease agreement as the lease term,

which is currently set to expire on April 30, 2026. As of June 30, 2023, the Company is not able to determine if any renewal options will be exercised.

The Company leases its premises in Houston, Texas under an operating lease which was renewed on November 19, 2020. This renewed lease agreement will commence under an operating lease agreement that is noncancelable from commencement until May 1, 2024.

On March 22, 2021, the Company’s Board of Directors approved a lease expansion within its premises in Houston, Texas. The amended lease agreement commenced on August 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 15,385 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day notice of cancellation.

Two further amendments were executed in 2021. The agreements commenced on November 1, 2021, and December 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 3,684 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day notice of cancellation.

An amendment to the lease agreement was executed in January 2022 and commenced May 1, 2022. The amendment added approximately 9,352 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on May 1, 2026. The termination date is effective after a 90-day notice of cancellation. In year one and two monthly rent is $4,800 per month, in year three and four monthly rent is $4,896 per month, and in year five monthly rent is $5,000 per month.

If the Company exercises the cancellation option, the Company must also pay the lessor a termination payment equal to three months of base rent.

The Company entered into a sublease of three suites for the use of certain fixture, fixtures and equipment on June 2, 2023. The lease commenced on June 5, 2023 under an operating lease agreement that is noncancelable until April 29, 2026. The monthly rent is $6,444 and remains flat during the period of the lease. The rent income received for this sublease is recorded in other income.

The following table indicates the balance sheet line items that include the right-of-use assets and lease liabilities for our operating lease:



	June 30, 2023			December 31, 2022
	Operating lease			Operating lease
Right-of-Use Asset
Operating lease	$	1,840,400	$	2,117,300
Total right-of use asset	$	1,840,400	$	2,117,300

Lease Liabilities
Operating lease - short term	$	(608,800)	$	(584,400)
Operating lease - long term		(1,231,700)		(1,544,900)
Total lease liabilities	$	(1,840,500)	$	(2,129,300)

For the three months and six months ended June 30, 2023, the components of lease expense were as follows:


		Three Months Ended			Three Months Ended			Six Months Ended			Six Months Ended
		June 30, 2023			June 30, 2022		June 30, 2023				June 30, 2022
Operating lease cost allocated to research and development expense	$	89,500		$	131,300		$	179,000		$	213,700
Operating lease cost allocated to general and administrative expense		89,500			38,200			179,000			106,300
Total lease expense	$	179,000		$	169,500		$	358,000		$	320,000
Weighted-average remaining lease term		2.84			3.84			2.84			3.84
Weighted-average discount rate		7.12	%		7.12	%		7.12	%		7.12	%

As of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows:




Maturity of Lease Liabilities		Operating lease
2023 (remaining)	$	358,800
2024		717,600
2025		724,700
2026		242,800
Total lease payments		2,043,900
Less: imputed interest		(203,400)
Present value of lease payments		1,840,500

The Company maintained a month-to-month lease in Arlington, VA, until October 1, 2022, which was considered a short-term lease. The Company elected to exclude this lease from the determination of the right-of-use asset and lease liability, as permitted under ASC 842. The Company recognized the lease payments in profit or loss in the statement of operations on a straight-line basis over the term of the lease. The monthly rent expense prior to termination of the lease was $2,500 per month. For the six months ended June 30, 2022, short-term lease expense was $15,000.

ORGANIZATION

6 Months Ended

Jun. 30, 2023

ORGANIZATION

ORGANIZATION

KIROMIC BIOPHARMA, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1.	ORGANIZATION

Nature of Business

Kiromic BioPharma, Inc. and subsidiaries (the "Company") is a clinical stage fully integrated biotherapeutics company formed under the Texas Business Organizations Code in December 2012. The Company maintains offices in Houston, Texas. The Company has not generated any revenues to date.

The Company is an Artificial Intelligence (“AI”) driven, end-to-end allogeneic cell therapy company, currently developing multi-indication allogeneic T cell therapies that exploit the natural potency of Gamma Delta T cells (“GDTs”) to target solid tumors. Our end-to-end approach consists of target discovery and validation, product development, and current good manufacturing practices (“cGMP”), which we believe will allow us to leverage a new framework for the next generation of cell therapies. We also have new technologies in development to support our end-to-end approach.

From a development standpoint, we utilize innovative engineered and non-engineered GDT manufacturing technologies and are developing proprietary, virus-free cell engineering tools to develop novel therapies for solid tumors that we believe will be effective and cost-efficient. Deltacel is our first allogeneic off-the-shelf GDT cell-based product in Phase 1 clinical stage. Our ProcelÔ (“Procel”) and IsocelÔ (“Isocel”) product candidates consist of allogeneic, cryopreserved, and engineered GDT cells and they are currently in the preclinical development stage. Our Deltacel product candidate consists of non-engineered GDTs that have been expanded, enriched, and activated ex-vivo through a proprietary process, and are intended to treat solid tumors regardless of the specific tumor antigen expression. Our Procel product candidate consists of engineered GDTs and is intended to be used to target PD-L1. Our Isocel product candidate consists of engineered GDTs and is intended to be used to target Mesothelin Isoform 2 positive tumors (“Iso-Meso”).

We currently have three product candidates: 1) Deltacel: not-engineered GDTs, expanded and activated with proprietary technology; 2) Procel: GDTs engineered with a PD-1 switch receptor; and 3) Isocel: GDTs engineered with an anti-Mesothelin isoform 2 Chimeric Antigen Receptor.

We have a total of five clinical programs to study our key product candidates:

Deltacel-01: This phase 1 clinical trial will evaluate Deltacel in combination with low-dose radiation for patients with non-small cell lung cancer (NSCLC)

Procel combination: This phase 1 clinical trial is expected to evaluate Procel in combination with low-dose radiation for patients with PD-L1 positive solid malignancies.

Alexis-PRO-1: This phase 1 clinical trial is expected to evaluate Procel in patients with PD-L1 positive solid malignancies.

Isocel combination: This phase 1 clinical trial is expected to evaluate Isocel in combination with low-dose radiation for patients with Mesothelin Isoform 2 positive solid malignancies.

Alexis-ISO-1: This phase 1 clinical trial is expected to evaluate Isocel in patients with Mesothelin Isoform 2 positive solid malignancies.

In June 2021, the FDA noted deficiencies in the chemistry, manufacturing, and control (CMC) sections of Alexis-PRO-1 (clinical trial evaluating Procel) and Alexis-ISO-1 (clinical trial evaluating Isocel) IND applications, consequently placing them on clinical hold.

On July 13, 2021, the Company received the FDA’s formal clinical hold letters, which asked the Company to address key components regarding the chemical, manufacturing, and control components of the IND applications. The basis for the hold was mainly rooted in the use of a non-suitable retroviral vector to engineer the gamma delta T cells. The Company is developing a novel and virus-independent engineering method, which will result in the submission of new IND applications (numbers 2 to 5 above). These applications are expected to be ready for submission to the FDA in the first

half of 2025, subject to sufficient financing to support the progression of the developments of those additional clinical trial candidates.

IND #1 (number 1 above) will evaluate Deltacel GDTs in combination with low-dose radiation. We submitted the IND for the Deltacel trial on March 31, 2023. On April 28, 2023, the FDA authorized us to proceed with the first-in-human clinical trial of Deltacel (IND #1). We began the clinical trial activation process during the three months ended June 30, 2023.

Reverse Stock Split — On March 10, 2023, the Company’s Board of Directors approved a one-for-thirty reverse split of the Company’s issued and outstanding shares of common stock (“the Reverse Stock Split”). In addition, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, restricted stock units and warrants to purchase shares of common stock and the number of shares reserved for issuance pursuant to the Company’s equity incentive compensation plans. Any fraction of a share of common stock that would be created as a result of the Reverse Stock Split was rounded up to the next whole share. Unless noted otherwise, all common shares and per share amounts contained in the consolidated financial statements have been retroactively adjusted for the Reverse Stock Split.

Going Concern— These condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. The Company had negative cash flow from operations of $10,588,800 for the six months ended June 30, 2023, and an accumulated deficit of $114,012,200 as of June 30, 2023. To date, the Company has relied on equity and debt financing to fund its operations. The Company’s product candidates are still in the early stages of development, and substantial additional financing will be needed by the Company to fund its operations and ongoing research and development efforts prior to the commercialization, if any, of its product candidates. The Company does not have sufficient cash on hand or available liquidity to meet its obligations through the twelve months following the date the condensed consolidated financial statements are issued. This condition raises substantial doubt about the Company’s ability to continue as a going concern.

Given its projected operating requirements and its existing cash and cash equivalents, management’s plans include evaluating different strategies to obtain the required funding of future operations. These plans may include, but are not limited to, obtaining funding from current or new investors, including through private placements or public offering. However, there can be no assurance that the Company will be able to secure financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Therefore, the plans cannot be deemed probable of being implemented. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern. In the event the Company is unable to secure sufficient financing to allow it to meet its obligations as they become due, the Company may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation.

The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

CONVERTIBLE DEBT (Details)	6 Months Ended
CONVERTIBLE DEBT (Details)	Jun. 30, 2023 USD ($) item	Apr. 30, 2023 USD ($)
Debt Instrument
Proceeds from senior secured convertible note payable	$ 12,400,000
Aggregate principal amount of convertible debt exchanged	$ 8,000,000	$ 8,000,000
25% Senior Secured Convertible Promissory Notes
Debt Instrument
Number of promissory notes issued \| item	8
Principal amount	$ 16,400,000
Proceeds from senior secured convertible note payable	$ 12,400,000
Interest rate (as a percent)	25.00%	25.00%
Note term	1 year
Interest rate increase to per annum	27.00%
Aggregate principal amount of convertible debt exchanged		$ 8,000,000

NET LOSS PER SHARE OF COMMON STOCK - Series C Stock (Details) - USD ($)	3 Months Ended	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2023	Apr. 30, 2023	Apr. 02, 2023	Dec. 31, 2022
Debt conversion
Aggregate principal amount of convertible debt exchanged	$ 8,000,000	$ 8,000,000	$ 8,000,000
Preferred stock, issued	8,000	8,000			0
Preferred dividends	$ 515,100	$ 515,100
Series C Preferred Stock
Debt conversion
Annual dividend rate		25.00%
Preferred stock, issued	8,000	8,000		8,000
Preferred dividends		$ 515,100

LEASES - Lease information (Details)					2 Months Ended
LEASES - Lease information (Details)	Jun. 05, 2023 USD ($) item	May 01, 2022 USD ($) ft² item	Jan. 01, 2022	Aug. 01, 2021 ft²	Dec. 31, 2021 ft² item
Leases
Lease, Practical Expedients, Package [true false]			true
Additional office space leased \| ft²		9,352		15,385	3,684
Period of time after notice of cancellation that the lease effectively terminates		90 days		90 days	90 days
Number of lease amendments executed \| item					2
Number of months rent due as a termination payment if lease cancellation option exercised \| item		3
Monthly rent - Years one and two		$ 4,800
Monthly rent - Years three and four		4,896
Monthly rent - Year five		$ 5,000
Number of suites sublet \| item	3
Monthly rent on subleases	$ 6,444

STOCKHOLDERS EQUITY

6 Months Ended

Jun. 30, 2023

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

10.STOCKHOLDERS’ EQUITY

Stock— As of June 30, 2023 and December 31, 2022, the Company was authorized to issue 60,000,000 shares of preferred stock (24,000,000 shares designated as Series A-1 Preferred Stock and 16,500,000 shares designated as Series B Preferred stock) and 300,000,000 shares of common stock (1,176,260 and 648,384 shares issued and outstanding, respectively). Additionally, for the six months ended June 30, 2023, the Company authorized the issuance of 8,000 shares of Series C Convertible Voting Preferred Stock (the “Series C Stock”). The Company issued 8,000 shares of Series C Stock on April 2, 2023 as part of the Exchange agreement discussed below, of which 8,000 shares remain outstanding as of June 30, 2023.

The Series C Stock is convertible into shares of the Company’s common stock, par value $0.001 per share. The Series C Preferred Stock is voting stock and holders of the Series C Preferred Stock are entitled to vote together with the Common Stock on an as-if-converted-to-Common-Stock basis as determined by dividing the Liquidation Preference with respect to such shares of Series C Preferred Stock by the Conversion Price. Holders of Common Stock are entitled to one vote for each share of Common Stock held on all matters submitted to a vote of stockholders. Accordingly, holders of Series C Preferred Stock will be entitled to one vote for each whole share of Common Stock into which their Series C Preferred Stock is then-convertible on all matters submitted to a vote of stockholders.

Cumulative Rights of Series C Stock Shareholders— The Series C Stock accumulates undeclared dividends at an annual rate of 25%. Unpaid dividends and undeclared dividends are added to the aggregate Liquidation Preference, which also includes the face value of the Series C Stock outstanding. In the event of any liquidation of the Company, holders of shares of Series C Stock then outstanding shall be entitled to be paid the Liquidation Preference out of the assets of the Company available for distribution to its stockholders, before any payment shall be made to the holders of any other shares of capital. As of June 30, 2023 and December 31, 2022, the outstanding Liquidation Preference of the Series C Stock is $8,515,100 and zero, respectively.

Participating Rights of Series C Stock Shareholders— In the event the Company declares a dividend, and all cumulative dividends have been distributed, the Series C stock participates in any remaing declared dividends to be paid equal to (on an as-if-converted-to-common-stock basis) and in the same form as dividends paid on shares of common stock.

Exchange Agreement

In April 2023, the Company entered into an Exchange Agreement with the holder of promissory notes to exchange an aggregate principal amount of $8 million of the Company’s 25% Senior Secured Convertible Promissory Notes for 8,000 shares of Series C Stock. The $8 million Senior Secured Convertible Promissory Notes is the aggregate of four promissory notes that were issued in the previous months, for $2 million each.

Representative’s Warrants—In connection with a public offering on October 15, 2020, the Company granted the underwriters warrants (the “Underwriters’ Warrants”) to purchase an aggregate of 2,083 shares of common stock at an exercise price of $450.00 per share. The Underwriters’ Warrants have a five-year term and were not exercisable prior to April 13, 2021. All of the Underwriters’ Warrants were outstanding and exercisable at June 30, 2023 and December 31, 2022. The warrants related to the IPO stock discount will be fully amortized in July 2024.

In connection with a public offering on July 2, 2021, the Company granted the underwriters warrants to purchase an aggregate of 13,333 shares of common stock at an exercise price of $187.50 per share, The Underwriters’ Warrants have a five-year term. All of the Underwriters’ Warrants were outstanding as of June 30, 2023 and December 31, 2022. The warrants related to the Public Offering stock discount will be fully amortized in April 2025.

Standby Equity Purchase Agreement

On May 24, 2023, we exercised the Commitment increase under the SEPA and issued to YA II PN, Ltd. 97,000 shares of common stock at a purchase price of $3.89, for an advance amount of $377,000.

On June 2, 2023, we exercised an additional Commitment increase under the SEPA and issued to YA II PN, Ltd. 100,000 shares of common stock at a purchase price of $2.82, for an advance amount of $282,100.

- 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
-Section 50
-Paragraph 13
-Subparagraph (b)
-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
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 16
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 40
-Section 50
-Paragraph 6
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

PROPERTY AND EQUIPMENT (Tables)

6 Months Ended

Jun. 30, 2023

PROPERTY AND EQUIPMENT

Schedule of property and equipment


	June 30, 2023		December 31, 2022
Equipment	$	3,041,900	$	3,041,900
Leasehold improvements		7,298,500		7,298,500
Office furniture, fixtures, and equipment		137,300		137,300
Software		359,500		359,500
Construction in progress		30,400		—
		10,867,600		10,837,200
Less: Accumulated depreciation		(3,805,800)		(2,700,300)
Total	$	7,061,800	$	8,136,900

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

6 Months Ended

Jun. 30, 2023

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

5.ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consisted of the following as of June 30, 2023 and December 31, 2022.


	June 30, 2023		December 31, 2022
Accrued litigation *	$	1,770,000	$	—
Accrued compensation		323,500		668,700
Accrued consulting and outside services		221,300		212,900
Total	$	2,314,800	$	881,600

* See Note 13 Subsequent Events for more information.

STOCK-BASED COMPENSATION - Stock Options (Details) - Stock Options - USD ($)	3 Months Ended	6 Months Ended		12 Months Ended
	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Stock Incentive Plan 2017
Stock option activity
Options outstanding at beginning of year		11,286	12,697	12,697
Cancelled and forfeited		(5,433)	(1,401)
Balance at June 30:	11,296	5,853	11,296	11,286
Options exercisable at June 30	11,165	5,853	11,165
Intrinsic value of options exercisable		$ 0		$ 0
Weighted average exercise price
Options outstanding at beginning of year		$ 254.40	$ 257.10	$ 257.10
Cancelled and forfeited		215.35	275.70
Balance at June 30	$ 254.70	285.36	254.70	$ 254.40
Options exercisable at June 30	$ 255.00	$ 285.36	$ 255.00
Additional stock option information
Stock compensation expense	$ 10,000		$ 67,000
Total unrecognized stock compensation expense		$ 0
Weighted-average remaining contractual life		4 years 5 months 4 days		4 years 11 months 4 days
Stock Incentive Plan 2017 \| Research and development
Additional stock option information
Stock compensation expense	3,000		52,000
Stock Incentive Plan 2017 \| General and administrative
Additional stock option information
Stock compensation expense	$ 7,000		$ 15,000
Stock Incentive Plan 2021
Stock option activity
Options outstanding at beginning of year		21,420
Granted			24,480
Cancelled and forfeited		(9,180)
Balance at June 30:	24,480	12,240	24,480	21,420
Options exercisable at June 30	12,240	12,240	12,240
Weighted average exercise price
Options outstanding at beginning of year		$ 12.90
Granted			$ 12.90
Cancelled and forfeited		12.90
Balance at June 30	$ 12.90	12.90	12.90	$ 12.90
Options exercisable at June 30	$ 12.90	$ 12.90	12.90
Weighted average grant date fair value for options granted and expected to be vested during the year:			$ 10.80
Additional stock option information
Stock compensation expense		$ 0	$ 0
Weighted-average remaining contractual life		4 years 11 months 4 days

STOCKHOLDERS EQUITY - Representative's Warrants (Details) - Common Stock Warrants - Representative - $ / shares	Jul. 02, 2021	Oct. 15, 2020
Initial Public Offering
Weighted average valuation assumptions
Warrants and Rights Outstanding, Term		5 years
Warrants
Number of warrants granted		2,083
Warrant exercise price		$ 450.00
Public Offering
Weighted average valuation assumptions
Warrants and Rights Outstanding, Term	5 years
Warrants
Number of warrants granted	13,333
Warrant exercise price	$ 187.50

PROPERTY AND EQUIPMENT

6 Months Ended

Jun. 30, 2023

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

4.	PROPERTY AND EQUIPMENT

Property and equipment consisted of the following as of June 30, 2023 and December 31, 2022:


	June 30, 2023		December 31, 2022
Equipment	$	3,041,900	$	3,041,900
Leasehold improvements		7,298,500		7,298,500
Office furniture, fixtures, and equipment		137,300		137,300
Software		359,500		359,500
Construction in progress		30,400		—
		10,867,600		10,837,200
Less: Accumulated depreciation		(3,805,800)		(2,700,300)
Total	$	7,061,800	$	8,136,900

Depreciation expense was $549,600 and $399,100 for the three months ended June 30, 2023 and 2022, respectively, and $1,105,400 and $581,900 for the six months ended June 30, 2023 and 2022, respectively. Depreciation expense is allocated between research and development and general and administrative operating expenses on the condensed consolidated statements of operations.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Nonvested Stock Options and Warrants (Details)	6 Months Ended
	Jun. 30, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Expected dividend yield	0.00%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2.	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification ("ASC") 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. Operating results for interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2022. The results of operations for the period ended June 30, 2023 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2022 contains financial information taken from the audited Company consolidated financial statements as of that date.

All intercompany balances were eliminated upon consolidation.

Use of Estimates—The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include determination of the fair value of common stock and related stock-based compensation, warrants to purchase common stock underlying shares of Series B Preferred Stock and public offering common stock, and estimating services incurred by third-party service providers used to recognize research and development expense.

Concentrations of Credit Risk and Other Uncertainties—Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. Substantially all of the Company’s cash and cash equivalents were deposited in accounts at a small number of national financial institutions. Account balances may at times exceed federally-insured limits. The Company has not incurred losses related to these cash and cash equivalents deposited at financial institutions and management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash is held.

The Company is subject to certain risks and uncertainties from changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: the ability to obtain regulatory approval and market acceptance of, and reimbursement for, the Company’s product candidates; the performance of third-party clinical research organizations and manufacturers; protection of the intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; the Company’s ability to attract and retain employees necessary to support commercial success; and changes in the industry or customer requirements including the emergence of competitive products with new capabilities.

Income Taxes—The Company files federal and state income tax returns, utilizing the accrual basis of accounting. Income taxes are provided for the tax effects of transactions reported in the condensed consolidated financial statements and consist of taxes currently due and deferred taxes. Certain transactions of the Company may be subject to accounting methods for income tax purposes, which differ from the accounting methods used in preparing these condensed consolidated financial statements in accordance with GAAP. Accordingly, the net income or loss of the Company reported for income tax purposes may differ from the balances reported for those same items in the accompanying condensed consolidated financial statements.

Deferred tax assets and liabilities are recognized for the future tax consequences attributable between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which such temporary differences are expected to be recovered or settled. The Company records valuation allowances to reduce deferred income tax assets to the amount that is more likely than not to be realized.

The Company records uncertain tax positions in accordance with ASC 740, Income Taxes, on the basis of a two-step process in which (1) the Company determines whether it is more-likely-than-not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying condensed consolidated statements of operations. No such interest or penalties were recognized during the three and six months ended June 30, 2023 or 2022.

Research and Development Expense—The Company expenses research and development costs as incurred. Research and development expenses include personnel and personnel-related costs, costs associated with the Company’s clinical development activities including costs of outside consultants and contractors, the submission and maintenance of regulatory filings, equipment and supplies used in developing products prior to market approval and an allocation of certain overhead costs such as facility and related expenses.

The Company accrues and expenses costs of services provided by contract research organizations in connection with preclinical studies and contract manufacturing organizations engaged to manufacture clinical trial material, costs of licensing technology, and costs of services provided by research organizations and service providers. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred if the technology is not expected to have any alternative future uses other than the specific research and development project for which it was intended. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed rather than when the payment is made.

Net Loss per Share Attributable to Common Stockholders—The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.

Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities.

Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, convertible preferred stock and warrants to purchase shares of convertible preferred stock are considered potential dilutive common shares.

Stock-Based Compensation—The Company records stock compensation expense related to the 2017 Equity Incentive Plan (the “2017 Plan”) and the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”) in accordance with ASC 718, Compensation—Stock Compensation. The Company measures and recognizes stock compensation expense for all stock-based awards, including stock options, based on estimated fair values recognized using cliff vesting or the straight-line method over the requisite service period. The fair value of stock options is estimated on the grant date using the Black-Scholes option-valuation model (the “Black-Scholes model”). The calculation of stock-based compensation expense requires that the Company make assumptions and judgments about the variables used in the Black-Scholes model, including the fair value of the Company’s common stock, expected term, expected volatility of the underlying common stock, and risk-free interest rate. Forfeitures are accounted for when they occur.

The Company estimates the grant-date fair value of stock options using the Black-Scholes model and the assumptions used to value such stock options are determined as follows:

Expected Term. The expected term represents the period that the Company’s stock options are expected to be outstanding. Due to limitations on the sale or transfer of the Company’s common stock under the lock-up agreements and market standoff components of the stock option agreements, the Company does not believe its historical exercise pattern is indicative of the pattern it will experience after restricted periods expire. The Company uses the Staff Accounting Bulletin (“SAB”) No. 110, simplified method to calculate the expected term, which is the average of the contractual term and vesting period.

Risk-Free Interest Rate. The Company bases the risk-free interest rate used in the Black-Scholes model on the implied yield available on US Treasury zero-coupon issues with a term equivalent to that of the expected term of the stock options for each stock option group.

Volatility. The Company determines the price volatility based on the historical volatilities of industry peers as it has limited trading history for its common stock price. The Company intends to continue to consistently apply this process using the same or a similar peer group of public companies, until a sufficient amount of historical information regarding the volatility

of its own common stock price becomes available, or unless circumstances change such that the identified peer companies are no longer similar, in which case other suitable peer companies whose common stock prices are publicly available would be utilized in the calculation.

Dividend Yield. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy. To date, the Company has not declared any dividends and, therefore, the Company has used an expected dividend yield of zero.

Common Stock Valuations. We use our listed Nasdaq Capital Market closing price on the grant date to determine common stock valuation.

Segment Data—The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

Recently Issued Accounting Pronouncements—From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position, results of operations, or cash flows upon adoption.

In June 2016, FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326). The amendments in ASU 2016-13 affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off-balance-sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial asset(s) to present the net carrying value at the amount expected to be collected on the financial asset. On October 16, 2019, the FASB has changed the effective date of this standard applicable to the Company as an emerging growth company to January 1, 2023. The Company has evaluated the potential impact of this standard on its financial position, results of operations, and cash flows, and determined that it is immaterial to the financial statements as of June 30, 2023.

Condensed Consolidated Statements of Cash Flows - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (12,064,700)	$ (15,802,800)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation	1,105,400	581,900
Operating lease non-cash expense	276,900	139,200
Stock compensation expense	56,100	264,300
Amortization of debt issuance costs	445,400
Changes in operating assets and liabilities, net of effects from acquisitions:
Accounts receivable		16,200
Prepaid expenses and other current assets	(962,300)	176,800
Accounts payable	(1,339,900)	794,500
Interest payable	749,800
Accrued expenses and other current liabilities	1,433,300	413,600
Operating lease liability	(288,800)	(131,700)
Net cash used for operating activities	(10,588,800)	(13,548,000)
Cash flows from investing activities:
Purchases of property and equipment		(4,955,700)
Net cash used for investing activities		(4,955,700)
Cash flows from financing activities:
Proceeds from senior secured convertible note payable	12,400,000
Proceeds from issuance of common stock	659,100
Stock issuance costs	(81,700)
Repayments of note payable	(329,600)	(339,600)
Net cash provided by (used for) financing activities	12,647,800	(339,600)
Net change in cash and cash equivalents	2,059,000	(18,843,300)
Cash and cash equivalents:
Beginning of period	645,200	25,353,900
End of period	2,704,200	6,510,600
Supplemental disclosures of cash flow information:
Right-of-use asset/lease liability recognized from ASC842 implementation		2,232,700
Conversion of 25% senior convertible promissory notes into preferred stock	8,000,000
Conversion of subordinated convertible notes into shares of common stock	2,914,000
Accruals for property and equipment purchases		1,154,900
Stock issuance costs in accounts payable	2,900
Cash paid for interest on note payable	34,900	5,500
Right-of-use asset/liability acquired through lease liability		$ 204,800
Construction in progress in accounts payable	30,400
Debt issuance costs in accounts payable	$ 620,000

SUBSEQUENT EVENTS (Details)		1 Months Ended	3 Months Ended	6 Months Ended
SUBSEQUENT EVENTS (Details)	Jul. 18, 2023 USD ($) item shares	Apr. 30, 2023 USD ($) item shares	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) item $ / shares shares	Aug. 07, 2023 USD ($)	Jul. 25, 2023 USD ($) $ / shares	Apr. 02, 2023 $ / shares shares	Dec. 31, 2022 $ / shares shares
Subsequent events
Aggregate principal amount of convertible debt exchanged		$ 8,000,000	$ 8,000,000	$ 8,000,000
Preferred stock, issued \| shares			8,000	8,000				0
Common stock, par value (in dollars per share) \| $ / shares			$ 0.001	$ 0.001			$ 0.001	$ 0.001
Litigation settlement loss			$ 1,770,000	$ 1,770,000
25% Senior Secured Convertible Promissory Notes
Subsequent events
Principal amount			$ 16,400,000	$ 16,400,000
Aggregate principal amount of convertible debt exchanged		$ 8,000,000
Interest rate (as a percent)		25.00%	25.00%	25.00%
Number of promissory notes issued \| item				8
Number of promissory notes exchanged \| item		4
Principal amount of the individual debt instruments exchanged.		$ 2,000,000
Interest rate increase to per annum				27.00%
Series C Preferred Stock
Subsequent events
Preferred stock, issued \| shares			8,000	8,000			8,000
Series C Preferred Stock \| 25% Senior Secured Convertible Promissory Notes
Subsequent events
Preferred stock, issued \| shares		8,000
Subsequent Event \| Settled Litigation \| Class Action
Subsequent events
Cash reserve in escrow					$ 2,300,000
Portion of litigation settlement to be reimbursed by insurance carrier					$ 530,000
Subsequent Event \| 25% Senior Secured Convertible Promissory Notes
Subsequent events
Principal amount	$ 6,000,000
Aggregate principal amount of convertible debt exchanged	$ 6,000,000
Interest rate (as a percent)	25.00%
Number of promissory notes issued \| item	3
Principal amount of the individual debt instruments exchanged.	$ 2,000,000
Subsequent Event \| 25% Senior Secured Convertible Promissory Note, Maturing July 2024
Subsequent events
Principal amount						$ 2,400,000
Interest rate (as a percent)						25.00%
Increased interest rate in event of default						27.00%
Common stock, par value (in dollars per share) \| $ / shares						$ 0.001
Conversion price \| $ / shares						$ 6.50
Maximum beneficial ownership percentage						9.99%
Subsequent Event \| Series C Preferred Stock
Subsequent events
Preferred stock, issued \| shares	6,000

INCOME TAXES

6 Months Ended

Jun. 30, 2023

INCOME TAXES

INCOME TAXES

12.INCOME TAXES

The Company’s effective tax rate from continuing operations was 0% for the three and six months ended June 30, 2023 and 2022. The Company recorded no income tax provision for the three or six months ended June 30, 2023.

The provision for income taxes during the interim reporting periods is calculated by applying an estimate of the annual effective tax rate for the full fiscal year to “ordinary” income or loss for the reporting period. Each quarter, the estimate of the annual effective tax rate is updated, and if the estimated effective tax rate changes, a cumulative adjustment is made. There is a potential for volatility of the effective tax rate due to several factors, including changes in the mix of the pre-tax income and the jurisdictions to which it relates, changes in tax laws, business reorganizations and settlements with taxing authorities.

The income tax rates vary from the US federal statutory rate of 21% primarily due to the full valuation allowance on the Company’s deferred tax assets. The Company has recorded the full valuation allowance based on an evaluation of both positive and negative evidence, including latest forecasts and cumulative losses in recent years. The Company has concluded that it was more likely than not that none of its deferred tax assets would be realized.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

LEASES - Operating lease liability maturities (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Operating leases
2023 (remaining)	$ 358,800
2024	717,600
2025	724,700
2026	242,800
Total lease payments	2,043,900
Less: imputed interest	(203,400)
Present value of lease payments	$ 1,840,500	$ 2,129,300

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)

6 Months Ended

Jun. 30, 2023

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Schedule of accrued expenses and other current liabilities


	June 30, 2023		December 31, 2022
Accrued litigation *	$	1,770,000	$	—
Accrued compensation		323,500		668,700
Accrued consulting and outside services		221,300		212,900
Total	$	2,314,800	$	881,600

NOTE PAYABLE

6 Months Ended

Jun. 30, 2023

NOTE PAYABLE

NOTE PAYABLE

6.NOTE PAYABLE

In November 2022, the Company entered into a financing arrangement for its Director and Officer Insurance policy. The total amount financed was approximately $610,700 with an annual interest rate of 8.49%, to be paid over a period of eleven months. As of June 30, 2023 and December 31, 2022, the remaining payable balance on the financed amount was $227,600 and $557,200, respectively.

Condensed Consolidated Statements of Operations - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating expenses:
Research and development	$ 1,966,600	$ 3,880,700	$ 4,041,600	$ 6,806,500
General and administrative	2,325,900	4,551,700	5,028,300	8,990,800
Total operating expenses	4,292,500	8,432,400	9,069,900	15,797,300
Loss from operations	(4,292,500)	(8,432,400)	(9,069,900)	(15,797,300)
Other expense:
Interest expense	(335,400)	(2,700)	(779,400)	(5,500)
Debt issuance amortization	(366,500)		(445,400)
Litigation settlement	(1,770,000)		(1,770,000)
Total other expense	(2,471,900)	(2,700)	(2,994,800)	(5,500)
Net loss	$ (6,764,400)	$ (8,435,100)	$ (12,064,700)	$ (15,802,800)
Net loss per preferred share, basic	$ (495.89)		$ (1,235.17)
Net loss per common share, basic	(3.22)	$ (16.25)	(8.07)	$ (30.64)
Net loss per preferred share, diluted	(495.89)		(1,235.17)
Net loss per common share, diluted	$ (3.22)	$ (16.25)	$ (8.07)	$ (30.64)
Weighted average preferred shares outstanding, basic	8,000		4,022
Weighted average common shares outstanding, basic	1,054,277	524,402	964,049	521,259
Weighted average preferred shares outstanding, diluted	8,000		4,022
Weighted average common shares outstanding, diluted	1,054,277	524,402	964,049	521,259

LEASES - Short-term Lease (Details) - USD ($)	6 Months Ended	9 Months Ended
LEASES - Short-term Lease (Details) - USD ($)	Jun. 30, 2022	Sep. 30, 2022
Leases
Monthly rent expense on short-term lease		$ 2,500
Short-term lease expense	$ 15,000

LEASES (Tables)

6 Months Ended

Jun. 30, 2023

Leases

Schedule of lessee's operating lease right-of-use assets and lease liabilities



	June 30, 2023			December 31, 2022
	Operating lease			Operating lease
Right-of-Use Asset
Operating lease	$	1,840,400	$	2,117,300
Total right-of use asset	$	1,840,400	$	2,117,300

Lease Liabilities
Operating lease - short term	$	(608,800)	$	(584,400)
Operating lease - long term		(1,231,700)		(1,544,900)
Total lease liabilities	$	(1,840,500)	$	(2,129,300)

Schedule of components of lease expense


		Three Months Ended			Three Months Ended			Six Months Ended			Six Months Ended
		June 30, 2023			June 30, 2022		June 30, 2023				June 30, 2022
Operating lease cost allocated to research and development expense	$	89,500		$	131,300		$	179,000		$	213,700
Operating lease cost allocated to general and administrative expense		89,500			38,200			179,000			106,300
Total lease expense	$	179,000		$	169,500		$	358,000		$	320,000
Weighted-average remaining lease term		2.84			3.84			2.84			3.84
Weighted-average discount rate		7.12	%		7.12	%		7.12	%		7.12	%

Schedule of maturities of operating lease liabilities




Maturity of Lease Liabilities		Operating lease
2023 (remaining)	$	358,800
2024		717,600
2025		724,700
2026		242,800
Total lease payments		2,043,900
Less: imputed interest		(203,400)
Present value of lease payments		1,840,500

STOCKHOLDERS' EQUITY - Standby Equity Purchase Agreement (Details) - USD ($)			6 Months Ended
	Jun. 02, 2023	May 24, 2023	Jun. 30, 2023
Note Purchase Agreement
Proceeds from issuance of common stock			$ 659,100
Standby Equity Purchase Agreement Financing
Note Purchase Agreement
Shares issued	100,000	97,000
Stock purchase price	$ 2.82	$ 3.89
Proceeds from issuance of common stock	$ 282,100	$ 377,000

LEASES - Balance sheet disclosures (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Leases
Operating lease right-of-use asset	$ 1,840,400	$ 2,117,300
Operating lease liability - short term	(608,800)	(584,400)
Operating lease liability - long term	(1,231,700)	(1,544,900)
Total lease liabilities	$ (1,840,500)	$ (2,129,300)

LEASES - Components of lease expense (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating leases
Operating lease cost	$ 179,000	$ 169,500	$ 358,000	$ 320,000
Weighted-average remaining lease term	2 years 10 months 2 days	3 years 10 months 2 days	2 years 10 months 2 days	3 years 10 months 2 days
Weighted-average discount rate	7.12%	7.12%	7.12%	7.12%
Research and development
Operating leases
Operating lease cost	$ 89,500	$ 131,300	$ 179,000	$ 213,700
General and administrative
Operating leases
Operating lease cost	$ 89,500	$ 38,200	$ 179,000	$ 106,300

NET LOSS PER SHARE OF COMMON STOCK - Computation of basic and diluted earnings per share (Details) - USD ($)	3 Months Ended				6 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022
Net loss per common share
Net loss	$ (6,764,400)	$ (5,300,300)	$ (8,435,100)	$ (7,367,700)	$ (12,064,700)	$ (15,802,800)
Less: Initial Public Offering Common Stock discount amortization	(24,900)		(24,900)		(49,500)	(49,600)
Less: Public offering Common Stock discount amortization	(61,000)		(61,000)		(121,400)	(121,400)
Less: Dividends attributable to preferred stock	(515,100)				(515,100)
Net loss attributable to common shareholders, basic	(7,365,400)		(8,521,000)		(12,750,700)	(15,973,800)
Net loss attributable to common shareholders, diluted	$ (7,365,400)		$ (8,521,000)		$ (12,750,700)	$ (15,973,800)
Weighted average common shares outstanding, basic	1,054,277		524,402		964,049	521,259
Weighted average preferred shares outstanding, basic	8,000				4,022
Weighted average common shares outstanding, diluted	1,054,277		524,402		964,049	521,259
Weighted average preferred shares outstanding, diluted	8,000				4,022
Net loss per common share, basic	$ (3.22)		$ (16.25)		$ (8.07)	$ (30.64)
Net loss per preferred share, basic	(495.89)				(1,235.17)
Net loss per common share, diluted	(3.22)		$ (16.25)		(8.07)	$ (30.64)
Net loss per preferred share, diluted	$ (495.89)				$ (1,235.17)
Preferred Stock
Net loss per common share
Net loss attributable to common shareholders, basic	$ (3,967,144)				$ (4,967,977)
Net loss attributable to common shareholders, diluted	$ (3,967,144)				$ (4,967,977)
Weighted average preferred shares outstanding, basic	8,000				4,022
Weighted average preferred shares outstanding, diluted	8,000				4,022
Net loss per preferred share, basic	$ (495.89)				$ (1,235.17)
Net loss per preferred share, diluted	$ (495.89)				$ (1,235.17)
Common Stock
Net loss per common share
Net loss attributable to common shareholders, basic	$ (3,398,256)		$ (8,521,000)		$ (7,782,723)	$ (15,973,800)
Net loss attributable to common shareholders, diluted	$ (3,398,256)		$ (8,521,000)		$ (7,782,723)	$ (15,973,800)
Weighted average common shares outstanding, basic	1,054,277		524,402		964,049	521,259
Weighted average common shares outstanding, diluted	1,054,277		524,402		964,049	521,259
Net loss per common share, basic	$ (3.22)		$ (16.25)		$ (8.07)	$ (30.64)
Net loss per common share, diluted	$ (3.22)		$ (16.25)		$ (8.07)	$ (30.64)

ORGANIZATION (Details)		6 Months Ended
ORGANIZATION (Details)	Mar. 10, 2023	Jun. 30, 2023 USD ($)	Jun. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)
ORGANIZATION
Stock split (Reverse stock split) ratio	30
Cash flow from operations		$ (10,588,800)	$ (13,548,000)
Accumulated deficit		$ (114,012,200)		$ (101,947,500)

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued litigation	$ 1,770,000
Accrued consulting and outside services	323,500	$ 668,700
Accrued compensation	221,300	212,900
Total	$ 2,314,800	$ 881,600

Condensed Consolidated Balance Sheets - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current Assets:
Cash and cash equivalents	$ 2,704,200	$ 645,200
Prepaid expenses and other current assets	2,009,000	1,043,700
Total current assets	4,713,200	1,688,900
Property and equipment, net	7,061,800	8,136,900
Operating lease right-of-use asset	1,840,400	2,117,300
Other assets	21,400	24,400
Total Assets	13,636,800	11,967,500
Current Liabilities:
Senior secured convertible promissory note, net	8,035,300	3,809,900
Accounts payable	6,621,500	7,308,100
Accrued expenses and other current liabilities	2,314,800	881,600
Interest payable	891,900	142,100
Note payable	227,600	557,200
Operating lease liability - short term	608,800	584,400
Total current liabilities	18,699,900	13,283,300
Subordinated convertible promissory note		2,914,000
Operating lease liability - long term	1,231,700	1,544,900
Total Liabilities	19,931,600	17,742,200
Stockholders' Equity:
Preferred Stock, $0.0001 par value: 60,000,000 shares authorized, 8,000 and 0, issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	1
Common stock, $0.001 par value: 300,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 1,176,260 and 648,384 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	1,176	648
Additional paid-in capital	107,716,223	96,172,152
Accumulated deficit	(114,012,200)	(101,947,500)
Total Stockholders' Equity	(6,294,800)	(5,774,700)
Total Liabilities and Stockholders' Equity	$ 13,636,800	$ 11,967,500

COMMITMENTS AND CONTINGENCIES

6 Months Ended

Jun. 30, 2023

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

7.COMMITMENTS AND CONTINGENCIES

License Agreements—The Company has entered into a number of licensing arrangements for various intellectual property and licensed patent rights for technologies being developed for commercial sale. As part of these arrangements, the Company is subject to contingent milestone payments in accordance with agreed-upon development objectives, as well as future royalty payments on product sales of the underlying assets. As of June 30, 2023 and December 31, 2022, the Company has not incurred any milestone or royalty liabilities related to these license agreements.

Legal Proceedings— On March 22, 2021, Jason Terrell (“Terrell”), a former consultant and former director of the Company, commenced an action against us in the Court of Chancery of the State of Delaware, C.A. No. 2021-0248-MTZ (the “Action”). In the Action, Terrell seeks a declaratory judgment that the Company is obligated to issue him (i) options to purchase 16,667 shares of common stock at a price of $5.10 per share pursuant to an alleged 2014 consulting agreement, and (ii) options to purchase an additional 16,667 shares of common stock at a price of $5.10 per share pursuant to an alleged January 2017 non-employee director options agreement. In his complaint, Terrell also claimed that, pursuant to the operative certificate of incorporation, he is entitled to indemnification from us for attorneys’ fees and costs he incurs in connection with the Action because the Action arises in connection with his position as a former director.

The Company disputes Terrell’s claims and allegations in the Action and intends to vigorously defend against them. On May 21, 2021, the Company filed a motion to dismiss Terrell’s claims in the actions with prejudice, arguing that (i) Terrell’s options-related claims fail because his 2014 and January 2017 agreements were explicitly superseded by a later options agreement, under which Terrell relinquished his prior options; and (ii) Terrell is not entitled to indemnification because the Action relates to contracts between the Company and Terrell in his personal capacity, and not in connection with any activities or duties of Terrell in his official capacity as former director. In response to the motion, filed on June 21, 2021, Terrell withdrew his claim for indemnification, but opposed the portion seeking dismissal of his declaratory judgment claim. The motion was fully briefed with the filing of the Company’s reply brief on July 7, 2021.

Oral argument was held before the Vice Chancellor on October 20, 2021. During oral argument, the Vice Chancellor invited the parties to submit supplemental letter briefs on the question of whether the Court of Chancery even had the authority to adjudicate the Action in light of the delegation of authority in Terrell’s most recent stock option agreement with the Company (the “SOA”) to the Company’s Compensation Committee to resolve all disputes regarding the interpretation of the SOA. The parties submitted simultaneous supplemental letters briefs on this issue on November 15, 2021. On January 20, 2022, the Vice Chancellor issued her decision on our motion to dismiss, ruling that the Action is stayed until the Compensation Committee itself resolves whether it has sole authority to resolve the parties’ contract interpretation dispute.

Subsequently, the parties agreed upon a process for coordinating submissions and/or presentations to the Compensation Committee. The parties made their respective written submissions to the Compensation Committee on March 31, 2022, and on July 21, 2022, the Compensation Committee determined that (i) the Compensation Committee has sole authority under the SOA to resolve the parties’ contract interpretation dispute, and (ii) Terrell’s most recent options agreement superseded and nullified any option rights Terrell may have had under his prior agreements. On August 2, 2022, the Vice Chancellor issued an order dismissing the Action for lack of subject matter jurisdiction.

On August 23, 2022, Terrell filed a notice of appeal of the Vice Chancellor’s order of dismissal to the Delaware Supreme Court.

Oral argument on Terrell’s appeal was held before the Delaware Supreme Court on February 8, 2023. On May 4, 2023, the Delaware Supreme Court issued a written opinion (the “Opinion”) reversing the Vice Chancellor’s order of dismissal and remanding to Chancery Court for further proceedings consistent with the Opinion. In its Opinion, the Delaware

Supreme Court affirmed several of the Chancery Court’s legal determinations on the motion to dismiss, but concluded that Chancery Court itself should independently review the Compensation Committee’s determinations under Delaware law.

The parties are awaiting guidance from the Chancery Court regarding further briefing and/or argument on our motion to dismiss.

In a separate matter, on or about August 17 and 23, 2021, Tony Tontat, who at the time was the Chief Financial Officer and a member of the Board, submitted substantially identical reports (the “Complaints”) through the Company’s complaint hotline. These Complaints, alleged, among other topics, risks associated with the Company’s public disclosures in securities filings and in statements made to the public, investors, and potential investors regarding (i) the anticipated timing of the FDA authorization of the IND applications and (ii) the anticipated timing of human clinical trials. These Complaints were subsequently submitted to the Audit Committee of the Board.

After receiving the Complaints, the Audit Committee recommended that the Board form, and the Board did in turn form, a Special Committee comprised of three independent directors (the “Special Committee”) to review the Complaints and other related issues (the “Internal Review”). The Special Committee retained an independent counsel to assist it in conducting the Internal Review.

On February 2, 2022, following the conclusion of the Internal Review, the Company’s Special Committee reported the results of its Internal Review to the Board. The Board approved certain actions to address the fact that the Company had received communications from the FDA on June 16 and June 17, 2021 that the FDA was placing the IND applications that the Company submitted to the FDA on May 14 and May 17, 2021 for the ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively, on clinical hold (the “June 16 and 17 FDA Communications”). The Company did not disclose the June 16 and 17, 2021 FDA Communications in the Registration Statement on Form S-1 (Registration No. 333-257427) that was filed on June 25, 2021 and declared effective on June 29, 2021, nor the final prospectus contained therein dated June 29, 2021 (collectively, the “Registration Statement”). The Company then consummated a public offering of $40 million of its common stock pursuant to the Registration Statement on July 2, 2021. On July 13, 2021, the Company received the FDA’s formal clinical hold letters, which asked the Company to address key components regarding the chemical, manufacturing, and control components of the IND applications. On July 16, 2021, the Company issued a press release disclosing that it had received comments from the FDA on the two INDs, but did not use the term “clinical hold.” The Company did not disclose the clinical hold in its Form 10-Q for the fiscal quarter ended June 30, 2021 that was filed with the Securities and Exchange Commission on August 13, 2021. On August 13, 2021, the Company issued a press release announcing that these INDs were placed on clinical hold.

Upon completion of the Internal Review, the Company voluntarily contacted the SEC to report certain information about the Internal Review. Since that time, the Company has been voluntarily cooperating with requests for information from the SEC and intends to fully cooperate with any further requests from the SEC.

In November 2022, we received a Grand Jury Subpoena (the “Subpoena”) from the U.S. Department of Justice requesting certain information from the company in connection with an ongoing investigation being conducted by the Federal Grand Jury in the Southern District of Texas. The Company is not a target of this investigation at this time.

As a result of the disclosure omission of the June 16 and 17 FDA Communications, on March 7, 2022, entities related to Sabby Management LLC (the “Sabby Entities”) and Empery Asset Management, LP (the “Empery Entities”) filed a complaint in the United States District Court for the Southern District of New York asserting claims against the Company and certain current and former officers and directors of the Company for alleged violations of Sections 11, 12, and 15 of the Securities Act of 1933 in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021. On July 1, 2022, the defendants filed motions to dismiss the complaint. In response, on July 22, 2022, the plaintiffs amended their complaint to, among other things, include the Company’s underwriters on the July 2, 2021 public offering, ThinkEquity LLC, as a defendant. The plaintiffs seek unspecified damages; rescission to the extent they still hold the Company’s securities, or if sold, rescissory damages; reasonable costs and expenses, including attorneys’ and experts’ fees; and other unspecified equitable and injunctive relief. The two parties reached a settlement agreement in principle on September 26, 2022, which the Company’s board of directors approved on September 27, 2022. The settlement contained a cash component of $75,000 payable to Sabby Entities and $75,000 to Empery Entities.

As part of the settlement, the Company also agreed to issue convertible notes (the “Settlement Notes”) in the aggregate principal amount of $1,656,720 to each of the Empery Entities and the Sabby Entities. The Settlement Notes are convertible into shares (the “Conversion Shares”) of the Company’s common stock at an initial conversion price per share of $9.20 and can be convertible into a maximum of 180,000 shares of the Company’s common stock to each of the Empery Entities and Sabby Entities, subject to the adjustment of the conversion price and a beneficial ownership limitation equivalent to 9.99%. The United States District Court for the Southern District of New York granted a motion jointly filed by the plaintiffs and defendants, pursuant to which the Settlement Notes will be unrestricted and exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), and the Conversion Shares, when issued upon conversion of the Settlement Notes in accordance with the terms set forth therein, will also be unrestricted and exempt from the registration requirements of the Securities Act.

There was also a related subordinated convertible promissory note totaling $2,914,000 on the balance sheet at December 31, 2022, which Empery held $1,502,700 and Sabby held $1,411,300. During the three months ended March 31, 2023, Empery and Sabby converted the totality of their notes into shares of common stock of 163,268 and 153,333, respectively, at a share price of $9.20.

On August 5, 2022, Ronald H. Karp filed a class action complaint in the United States District Court for the Southern District of New York (the “Karp Class Action”) covering the same subject matter as the Sabby Entities’ and Empery Entities’ claim discussed above asserting claims against the Company and certain current and former officers and directors for alleged violations of Sections 11, 12, and 15 of the Securities Act of 1933 in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with the certain statements and acts made by the defendants between June 25, 2021 and August 13, 2021.

On October 3, 2022, Joseph Podmore filed a class action complaint in the United States District Court for the Southern District of New York (the “Podmore Class Action”) covering the same subject matter as the Sabby Entities’ and Empery Entities’ claim discussed above asserting claims against the Company and certain current and former officers and directors for alleged violations of Sections 11, 12, and 15 of the Securities Act of 1933 in connection with the purchase of common stock through the Company’s public offering that closed on July 2, 2021 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with the certain statements and acts made by the defendants between June 25, 2021 and August 13, 2021.

The Karp Class Action and the Podmore Class Action are collectively referred to as the “Class Action.” See Note 13 – Subsequent Events for further discussion.

The Company regularly assesses all contingencies and believes, based on information presently known, the Company is not involved in any other matters that would have a material effect on the Company’s financial position, results of operations or cash flows.

INCOME TAXES (Details) - USD ($)	3 Months Ended		6 Months Ended
INCOME TAXES (Details) - USD ($)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
INCOME TAXES
Effective tax rate from continuing operations	0.00%	0.00%	0.00%	0.00%
Income tax provision	$ 0		$ 0
Federal statutory rate	21.00%	21.00%	21.00%	21.00%

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	6 Months Ended
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	Jun. 30, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation	Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification ("ASC") 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. Operating results for interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2022. The results of operations for the period ended June 30, 2023 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2022 contains financial information taken from the audited Company consolidated financial statements as of that date. All intercompany balances were eliminated upon consolidation.
Use of Estimates	Use of Estimates—The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include determination of the fair value of common stock and related stock-based compensation, warrants to purchase common stock underlying shares of Series B Preferred Stock and public offering common stock, and estimating services incurred by third-party service providers used to recognize research and development expense.
Concentrations of Credit Risk and Other Uncertainties	Concentrations of Credit Risk and Other Uncertainties—Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. Substantially all of the Company’s cash and cash equivalents were deposited in accounts at a small number of national financial institutions. Account balances may at times exceed federally-insured limits. The Company has not incurred losses related to these cash and cash equivalents deposited at financial institutions and management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash is held. The Company is subject to certain risks and uncertainties from changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: the ability to obtain regulatory approval and market acceptance of, and reimbursement for, the Company’s product candidates; the performance of third-party clinical research organizations and manufacturers; protection of the intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; the Company’s ability to attract and retain employees necessary to support commercial success; and changes in the industry or customer requirements including the emergence of competitive products with new capabilities.
Income Taxes	Income Taxes—The Company files federal and state income tax returns, utilizing the accrual basis of accounting. Income taxes are provided for the tax effects of transactions reported in the condensed consolidated financial statements and consist of taxes currently due and deferred taxes. Certain transactions of the Company may be subject to accounting methods for income tax purposes, which differ from the accounting methods used in preparing these condensed consolidated financial statements in accordance with GAAP. Accordingly, the net income or loss of the Company reported for income tax purposes may differ from the balances reported for those same items in the accompanying condensed consolidated financial statements. Deferred tax assets and liabilities are recognized for the future tax consequences attributable between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which such temporary differences are expected to be recovered or settled. The Company records valuation allowances to reduce deferred income tax assets to the amount that is more likely than not to be realized. The Company records uncertain tax positions in accordance with ASC 740, Income Taxes, on the basis of a two-step process in which (1) the Company determines whether it is more-likely-than-not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying condensed consolidated statements of operations. No such interest or penalties were recognized during the three and six months ended June 30, 2023 or 2022.
Research and Development Expense	Research and Development Expense—The Company expenses research and development costs as incurred. Research and development expenses include personnel and personnel-related costs, costs associated with the Company’s clinical development activities including costs of outside consultants and contractors, the submission and maintenance of regulatory filings, equipment and supplies used in developing products prior to market approval and an allocation of certain overhead costs such as facility and related expenses. The Company accrues and expenses costs of services provided by contract research organizations in connection with preclinical studies and contract manufacturing organizations engaged to manufacture clinical trial material, costs of licensing technology, and costs of services provided by research organizations and service providers. Upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred if the technology is not expected to have any alternative future uses other than the specific research and development project for which it was intended. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed rather than when the payment is made.
Net Loss per Share Attributable to Common Stockholders	Net Loss per Share Attributable to Common Stockholders—The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, convertible preferred stock and warrants to purchase shares of convertible preferred stock are considered potential dilutive common shares.
Stock-Based Compensation	Stock-Based Compensation—The Company records stock compensation expense related to the 2017 Equity Incentive Plan (the “2017 Plan”) and the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”) in accordance with ASC 718, Compensation—Stock Compensation. The Company measures and recognizes stock compensation expense for all stock-based awards, including stock options, based on estimated fair values recognized using cliff vesting or the straight-line method over the requisite service period. The fair value of stock options is estimated on the grant date using the Black-Scholes option-valuation model (the “Black-Scholes model”). The calculation of stock-based compensation expense requires that the Company make assumptions and judgments about the variables used in the Black-Scholes model, including the fair value of the Company’s common stock, expected term, expected volatility of the underlying common stock, and risk-free interest rate. Forfeitures are accounted for when they occur. The Company estimates the grant-date fair value of stock options using the Black-Scholes model and the assumptions used to value such stock options are determined as follows: Expected Term. The expected term represents the period that the Company’s stock options are expected to be outstanding. Due to limitations on the sale or transfer of the Company’s common stock under the lock-up agreements and market standoff components of the stock option agreements, the Company does not believe its historical exercise pattern is indicative of the pattern it will experience after restricted periods expire. The Company uses the Staff Accounting Bulletin (“SAB”) No. 110, simplified method to calculate the expected term, which is the average of the contractual term and vesting period. Risk-Free Interest Rate. The Company bases the risk-free interest rate used in the Black-Scholes model on the implied yield available on US Treasury zero-coupon issues with a term equivalent to that of the expected term of the stock options for each stock option group. Volatility. The Company determines the price volatility based on the historical volatilities of industry peers as it has limited trading history for its common stock price. The Company intends to continue to consistently apply this process using the same or a similar peer group of public companies, until a sufficient amount of historical information regarding the volatility of its own common stock price becomes available, or unless circumstances change such that the identified peer companies are no longer similar, in which case other suitable peer companies whose common stock prices are publicly available would be utilized in the calculation. Dividend Yield. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy. To date, the Company has not declared any dividends and, therefore, the Company has used an expected dividend yield of zero. Common Stock Valuations. We use our listed Nasdaq Capital Market closing price on the grant date to determine common stock valuation.
Segment Data	Segment Data—The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements—From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position, results of operations, or cash flows upon adoption. In June 2016, FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326). The amendments in ASU 2016-13 affect entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off-balance-sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial asset(s) to present the net carrying value at the amount expected to be collected on the financial asset. On October 16, 2019, the FASB has changed the effective date of this standard applicable to the Company as an emerging growth company to January 1, 2023. The Company has evaluated the potential impact of this standard on its financial position, results of operations, and cash flows, and determined that it is immaterial to the financial statements as of June 30, 2023.

STOCKHOLDERS' EQUITY - Exchange Agreement (Details)	1 Months Ended
STOCKHOLDERS' EQUITY - Exchange Agreement (Details)	Apr. 30, 2023 USD ($) item shares	Jun. 30, 2023 USD ($) shares	Apr. 02, 2023 shares	Dec. 31, 2022 shares
Note Purchase Agreement
Aggregate principal amount of convertible debt exchanged \| $	$ 8,000,000	$ 8,000,000
Preferred stock, issued \| shares		8,000		0
Series C Preferred Stock
Note Purchase Agreement
Preferred stock, issued \| shares		8,000	8,000
25% Senior Secured Convertible Promissory Notes
Note Purchase Agreement
Aggregate principal amount of convertible debt exchanged \| $	$ 8,000,000
Interest rate (as a percent)	25.00%	25.00%
Number of promissory notes exchanged \| item	4
Principal amount of the individual debt instruments exchanged. \| $	$ 2,000,000
25% Senior Secured Convertible Promissory Notes \| Series C Preferred Stock
Note Purchase Agreement
Preferred stock, issued \| shares	8,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Unrecognized tax benefits, interest or penalties	$ 0	$ 0	$ 0	$ 0

CONVERTIBLE DEBT- Maturity (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Debt Instrument
Total Convertible Promissory Note	$ 8,400,000	$ 4,000,000
Less: unamortized debt issuance costs	(364,700)	(190,100)
Convertible Promissory Note, net	8,035,300	3,809,900
Senior Secured Convertible Promissory Note, maturing December 12, 2023
Debt Instrument
Total Convertible Promissory Note		$ 4,000,000
Senior Secured Convertible Promissory Note, maturing March 28, 2024
Debt Instrument
Total Convertible Promissory Note	2,000,000
Senior Secured Convertible Promissory Note, maturing April 25, 2024
Debt Instrument
Total Convertible Promissory Note	2,000,000
Senior Secured Convertible Promissory Note, maturing May 24, 2024
Debt Instrument
Total Convertible Promissory Note	2,000,000
Senior Secured Convertible Promissory Note, maturing June 26, 2024
Debt Instrument
Total Convertible Promissory Note	$ 2,400,000

CONVERTIBLE DEBT

6 Months Ended

Jun. 30, 2023

CONVERTIBLE DEBT

CONVERTIBLE DEBT

9.CONVERTIBLE DEBT

The Company began issuing senior secured promissory notes (each a “CPN” and together the “Notes”) notes payable to a private accredited investor (the “Investor”) during 2022. The Company has continued to issue notes to the Investor during 2023. Through June 30, 2023, the Company has issued to the Investor eight notes totaling $16,400,000, of which $12,400,000 were issued during the six months ended June 30, 2023. The notes are each 25% Senior Secured Convertible Promissory Notes with largely consistent terms including a stated interest rate of 25% per year, a stated conversion price subject to a beneficial ownership limitation and share cap representing a certain percentage of the outstanding shares of Common Stock at the time of conversion, and a one year maturity. The stated interest rates for these notes increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon the occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the related note on the respective maturity date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency law. In April 2023, the Company executed an exchange agreement to convert $8,000,000 of convertible promissory notes principal into shares of preferred stock. See Note 10 – Stockholder’s Equity for further discussion..


	June 30, 2023		December 31, 2022
Senior Secured Convertible Promissory Note, maturing December 12, 2023	$	—	$	4,000,000
Senior Secured Convertible Promissory Note, maturing March 28, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing April 25, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing May 24, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing June 26, 2024		2,400,000		—
Total Convertible Promissory Note	$	8,400,000	$	4,000,000
Less: unamortized debt issuance costs		(364,700)		(190,100)
Convertible Promissory Note, net	$	8,035,300	$	3,809,900

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1E
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495348-112611

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

STOCKHOLDERS EQUITY - Stock (Details)	6 Months Ended
STOCKHOLDERS EQUITY - Stock (Details)	Jun. 30, 2023 USD ($) Vote $ / shares shares	Apr. 02, 2023 $ / shares shares	Dec. 31, 2022 USD ($) $ / shares shares
Common stock
Preferred stock, authorized	60,000,000		60,000,000
Common stock, authorized	300,000,000		300,000,000
Common stock, issued	1,176,260		648,384
Common stock, outstanding	1,176,260		648,384
Preferred stock, issued	8,000		0
Preferred stock, outstanding	8,000		0
Common stock, par value (in dollars per share) \| $ / shares	$ 0.001	$ 0.001	$ 0.001
Series A-1 Preferred Stock
Common stock
Preferred stock, authorized	24,000,000		24,000,000
Series B Preferred Stock
Common stock
Preferred stock, authorized	16,500,000		16,500,000
Series C Preferred Stock
Common stock
Preferred stock, authorized	8,000
Preferred stock, issued	8,000	8,000
Preferred stock, outstanding	8,000
Number of entitled votes per share \| Vote	1
Annual dividend rate	25.00%
Liquidation preference, value \| $	$ 8,515,100		$ 0
Common Stock
Common stock
Number of entitled votes per share \| Vote	1

COMMITMENTS AND CONTINGENCIES - Legal proceedings (Details)				3 Months Ended	6 Months Ended
	Sep. 26, 2022 USD ($) item $ / shares	Jul. 02, 2021 USD ($)	Mar. 22, 2021 $ / shares shares	Mar. 31, 2023 $ / shares shares	Jun. 30, 2023 USD ($)	Dec. 31, 2022 USD ($)
Legal proceedings
Proceeds from issuance of common stock					$ 659,100
Subordinated convertible promissory note						$ 2,914,000
Strategic Alliance Agreement
Legal proceedings
Proceeds from issuance of common stock		$ 40,000,000
Jason Terrell - 2014 Consulting Agreement
Legal proceedings
Number of stock options sought \| shares			16,667
Stock option exercise price \| $ / shares			$ 5.10
Jason Terrell - 2017 Non-employee Director Options Agreement
Legal proceedings
Number of stock options sought \| shares			16,667
Stock option exercise price \| $ / shares			$ 5.10
Sabby Entities
Legal proceedings
Cash settlement payments	$ 75,000
Convertible notes issued in settlement of legal proceedings	$ 1,656,720
Conversion price \| $ / shares	$ 9.20			$ 9.20
Maximum beneficial ownership percentage	9.99%
Subordinated convertible promissory note						1,411,300
Shares issued in conversion of subordinated promissory notes \| shares				153,333
Sabby Entities \| Maximum
Legal proceedings
Maximum shares to be issued under conversion \| item	180,000
Empery Entities
Legal proceedings
Cash settlement payments	$ 75,000
Convertible notes issued in settlement of legal proceedings	$ 1,656,720
Conversion price \| $ / shares	$ 9.20			$ 9.20
Maximum beneficial ownership percentage	9.99%
Subordinated convertible promissory note						$ 1,502,700
Shares issued in conversion of subordinated promissory notes \| shares				163,268
Empery Entities \| Maximum
Legal proceedings
Maximum shares to be issued under conversion \| item	180,000

NET LOSS PER SHARE OF COMMON STOCK

6 Months Ended

Jun. 30, 2023

NET LOSS PER SHARE OF COMMON STOCK

NET LOSS PER SHARE OF COMMON STOCK

3.NET LOSS PER SHARE OF COMMON STOCK

Basic and diluted net loss per common share is determined by dividing net loss less deemed dividends by the weighted-average common shares outstanding during the period. For all periods presented the common shares underlying the stock options, RSUs and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average common shares outstanding used to calculate both basic and diluted loss per common shares are the same. The following table illustrates the computation of basic and diluted loss per share:


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Net loss	$	(6,764,400)	$	(8,435,100)	$	(12,064,700)	$	(15,802,800)
Less: Initial Public Offering Common Stock discount amortization		(24,900)		(24,900)		(49,500)		(49,600)
Less: Public Offering Common Stock discount amortization		(61,000)		(61,000)		(121,400)		(121,400)
Less: Dividends attributable to preferred stock		(515,100)		—		(515,100)		—
Net loss attributable to common shareholders	$	(7,365,400)	$	(8,521,000)	$	(12,750,700)	$	(15,973,800)


	Three Months Ended				Three Months Ended
	June 30, 2023				June 30, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(3,398,256)	$	(3,967,144)	$	(8,521,000)	$	—
Weighted average shares outstanding, basic and diluted		1,054,277		8,000		524,402		—
Basic and diluted net loss per share	$	(3.22)	$	(495.89)	$	(16.25)	$	—


	Six Months Ended				Six Months Ended
	June 30, 2023				June 30, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(7,782,723)	$	(4,967,977)	$	(15,973,800)	$	—
Weighted average shares outstanding, basic and diluted		964,049		4,022		521,259		—
Basic and diluted net loss per share	$	(8.07)	$	(1,235.17)	$	(30.64)	$	—

For the three months ended June 30, 2023, there were 23,936 restricted stock units and 15,416 warrants, that were potentially dilutive securities excluded from the computations of diluted weighted-average shares of common stock.

During the six months ended June 30, 2023, the Company entered into an Exchange Agreement whereby outstanding promissory notes totaling $8,000,000 were exchanged for 8,000 shares of Series C Convertible Voting Preferred Stock (the “Series C Stock”). The Series C Stock accrues an annual 25% dividend, whether or not declared, which if unpaid is added to the aggregate liquidation preference. During the six months ended June 30, 2023, the preferred shareholders earned $515,100 of preferred dividends, which were not declared.

NET LOSS PER SHARE OF COMMON STOCK (Tables)

6 Months Ended

Jun. 30, 2023

NET LOSS PER SHARE OF COMMON STOCK

Schedule of earnings per share, basic and diluted


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Net loss	$	(6,764,400)	$	(8,435,100)	$	(12,064,700)	$	(15,802,800)
Less: Initial Public Offering Common Stock discount amortization		(24,900)		(24,900)		(49,500)		(49,600)
Less: Public Offering Common Stock discount amortization		(61,000)		(61,000)		(121,400)		(121,400)
Less: Dividends attributable to preferred stock		(515,100)		—		(515,100)		—
Net loss attributable to common shareholders	$	(7,365,400)	$	(8,521,000)	$	(12,750,700)	$	(15,973,800)


	Three Months Ended				Three Months Ended
	June 30, 2023				June 30, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(3,398,256)	$	(3,967,144)	$	(8,521,000)	$	—
Weighted average shares outstanding, basic and diluted		1,054,277		8,000		524,402		—
Basic and diluted net loss per share	$	(3.22)	$	(495.89)	$	(16.25)	$	—


	Six Months Ended				Six Months Ended
	June 30, 2023				June 30, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(7,782,723)	$	(4,967,977)	$	(15,973,800)	$	—
Weighted average shares outstanding, basic and diluted		964,049		4,022		521,259		—
Basic and diluted net loss per share	$	(8.07)	$	(1,235.17)	$	(30.64)	$	—

NOTE PAYABLE (Details) - USD ($)	1 Months Ended
NOTE PAYABLE (Details) - USD ($)	Nov. 30, 2022	Jun. 30, 2023	Dec. 31, 2022
Note payable
Note payable		$ 227,600	$ 557,200
Director and Officer Insurance Policy Financing
Note payable
Note payable	$ 610,700	$ 227,600	$ 557,200
Interest rate	8.49%
Note term	11 months

SUBSEQUENT EVENTS

6 Months Ended

Jun. 30, 2023

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

13.SUBSEQUENT EVENTS

Exchange Agreement

On July 18, 2023, the Company entered into an Exchange Agreement (the “July 18 Exchange Agreement”) with the holder of promissory notes of the Company (the “Holder”) pursuant to which the Holder agreed to exchange aggregate principal amount of $6 million of the Company’s 25% Senior Secured Convertible Promissory Notes (the “July 18 Exchange Notes”) for 6,000 shares of Series C Stock. The $6 million Senior Secured Convertible Promissory Notes is the aggregate of three promissory notes that were issued in the previous months, for $2 million each, as discussed in Note 9 above.

Board of Directors Appointment

On July 20, 2023, the Board of Directors appointed Pam Misajon and Mike Catlin as members of the Board of Directors. Ms. Misajon has been appointed chair of the Nominating and Corporate Governance Committee and member of the Compensation Committee, Mr. Catlin has been appointed chair of the Audit Committee and member of the Nominating and Corporate Governance Committee. After these nominations, the Company regained the audit committee requirements under Listing Rule 5605 (c)(4), meeting the expectations of the Nasdaq which gave the Company until November 16, 2023 for compliance.

Issuance of Senior Secured Convertible Promissory Note

On July 25, 2023, the Company issued a 25% Senior Secured Convertible Promissory Note (the “July 25 Note”) to the investor. The Note has a principal amount of $2,400,000, bears interest at a rate of 25% per annum (the “Stated Rate”) and matures on July 25, 2024 (the “July 25 Maturity Date”), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws.

The July 25 Note is convertible into shares of the Company’s common stock, par value $0.001 per share, at an initial conversion price of $6.50 per share, subject to a beneficial ownership limitation equivalent to 9.99%.

Settlement in Principle of the Class Action

On August 7, 2023, we entered into a term sheet with the plaintiffs in the Class Action, to settle in principle (and globally resolve) the Class Actions. In the Class Action, the plaintiffs have made allegations and asserted claims against the Company and certain current and former directors and officers, as well as the Company’s former underwriter, including for alleged violations of Sections 11, 12(a)(2), and 15 of the Securities Act of 1933 as well as Section 10(b) (and Rule 10b-5 promulgated thereunder) and Section 20(a) of the Securities Exchange Act of 1934 in connection with a public offering by the Company that closed on or about July 2, 2021. The Term Sheet provides, among other things, that it is subject to approval by the U.S. District Court for the Southern District of New York (the “Court”); that plaintiffs and the Company will prepare settlement materials consistent with the Term Sheet; that the settlement will globally resolve all claims and allegations; that no defendant admits any liability or any allegation; that the Company shall make cash consideration payments totaling $2,300,000 into an escrow account, of which $530,000 we expect to be paid by our insurance carrier directly to the plaintiffs, resulting in recognition of a $1.77 million expense in our income statement for the three and six months ended June 30, 2023. Such amounts shall be distributed as set forth in the Term Sheet, including that amounts shall be distributed upon approval of the settlement by the Court. The plaintiffs subsequently sent a letter to the Court on August 7, 2023, informing the Court of the settlement in principle and requesting that the Court stay all proceedings pending approval of the settlement.

STOCK-BASED COMPENSATION (Tables)

6 Months Ended

Jun. 30, 2023

Stock Incentive Plan 2017 | Stock Options

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of stock option activity


	2023			2022
		Weighted			Weighted
		Average			Average
		Exercise			Exercise
	Shares	Price		Shares	Price
Options outstanding at beginning of period	11,286	$	254.40	12,697	$	257.10
Granted	—		—	—		—
Exercised	—		—	—		—
Cancelled and forfeited	(5,433)		215.35	(1,401)		275.70
Balance at June 30	5,853	$	285.36	11,296	$	254.70
Options exercisable at June 30:	5,853	$	285.36	11,165	$	255.00

Schedule of stock-based compensation


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	—	$	3,000	$	—	$	52,000
General and administrative		—		7,000		—		15,000
Total	$	—	$	10,000	$	—	$	67,000

Stock Incentive Plan 2017 | Restricted Stock Units

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of restricted stock unit activity


	2023			2022
		Weighted Average			Weighted Average
		Grant Date			Grant Date
		Fair Value			Fair Value
	Shares	Per Share		Shares	Per Share
Nonvested RSUs at beginning of period	650	$	259.50	17,028	$	374.40
Granted	—		—	—		—
Vested	(251)		255.85	(356)		259.20
Cancelled and forfeited	(11)		260.10	(11,191)		383.70
Nonvested RSUs at June 30	388	$	285.36	5,481	$	362.70

Schedule of stock-based compensation


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	15,100	$	1,900	$	15,100	$	13,900
General and administrative		14,500		2,400		14,500		(4,700)
Total	$	29,600	$	4,300	$	29,600	$	9,200

Stock Incentive Plan 2021 | Stock Options

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of stock option activity


	2023			2022
		Weighted			Weighted
		Average			Average
		Exercise			Exercise
	Shares	Price		Shares	Price
Options outstanding at beginning of period	21,420	$	12.90	—	$	—
Granted	—		—	24,480		12.90
Exercised	—		—	—		—
Cancelled and forfeited	(9,180)		12.90	—		—
Balance at June 30	12,240	$	12.90	24,480	$	12.90
Options exercisable at June 30:	12,240	$	12.90	12,240	$	12.90
Weighted average grant date fair value for options granted during the year:		$	—		$	10.80

Stock Incentive Plan 2021 | Restricted Stock Units

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of restricted stock unit activity


	2023			2022
		Weighted Average			Weighted Average
		Grant Date			Grant Date
		Fair Value			Fair Value
	Shares	Per Share		Shares	Per Share
Nonvested RSUs at beginning of period	684	$	133.20	2,068	$	165.60
Granted	36,910		0.62	—		—
Vested	(13,425)		0.62	—		—
Cancelled and forfeited	(668)		126.60	(131)		126.60
Nonvested RSUs at June 30	23,501	$	20.41	1,937	$	168.30

Schedule of stock-based compensation


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	3,900	$	17,400	$	11,800	$	25,700
General and administrative		1,900		19,900		14,700		29,800
Total	$	5,800	$	37,300	$	26,500	$	55,500

Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($)	Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
Balance at beginning of period at Dec. 31, 2021		$ 516	$ 94,535,784	$ (67,216,500)	$ 27,319,800
Balance at beginning of period (in shares) at Dec. 31, 2021		516,284
Common stock discount amortization			85,100		85,100
Warrants underlying common stock issuance			(85,100)		(85,100)
Released restricted stock units		$ 4	(4)
Released restricted stock units (in shares)		3,236
Stock compensation expense			80,100		80,100
Net loss				(7,367,700)	(7,367,700)
Balance at end of period at Mar. 31, 2022		$ 520	94,615,880	(74,584,200)	20,032,200
Balance at end of period (in shares) at Mar. 31, 2022		519,520
Balance at beginning of period at Dec. 31, 2021		$ 516	94,535,784	(67,216,500)	27,319,800
Balance at beginning of period (in shares) at Dec. 31, 2021		516,284
Net loss					(15,802,800)
Balance at end of period at Jun. 30, 2022		$ 528	94,800,072	(83,019,300)	11,781,300
Balance at end of period (in shares) at Jun. 30, 2022		527,971
Balance at beginning of period at Mar. 31, 2022		$ 520	94,615,880	(74,584,200)	20,032,200
Balance at beginning of period (in shares) at Mar. 31, 2022		519,520
Common stock discount amortization			85,900		85,900
Warrants underlying common stock issuance			(85,900)		(85,900)
Released restricted stock units		$ 8	(8)
Released restricted stock units (in shares)		8,451
Stock compensation expense			184,200		184,200
Net loss				(8,435,100)	(8,435,100)
Balance at end of period at Jun. 30, 2022		$ 528	94,800,072	(83,019,300)	11,781,300
Balance at end of period (in shares) at Jun. 30, 2022		527,971
Balance at beginning of period at Dec. 31, 2022		$ 648	96,172,152	(101,947,500)	(5,774,700)
Balance at beginning of period (in shares) at Dec. 31, 2022		648,384
Common stock discount amortization			85,000		85,000
Warrants underlying common stock issuance			(85,000)		(85,000)
Released restricted stock units		$ 2	(2)
Released restricted stock units (in shares)		1,773
Conversion of subordinated convertible notes into shares of common stock		$ 329	2,913,671		2,914,000
Conversion of subordinated convertible notes into shares of common stock (in shares)		329,086
Stock compensation expense			20,700		20,700
Net loss				(5,300,300)	(5,300,300)
Balance at end of period at Mar. 31, 2023		$ 979	99,106,521	(107,247,800)	(8,140,300)
Balance at end of period (in shares) at Mar. 31, 2023		979,243
Balance at beginning of period at Dec. 31, 2022		$ 648	96,172,152	(101,947,500)	(5,774,700)
Balance at beginning of period (in shares) at Dec. 31, 2022		648,384
Conversion of subordinated convertible notes into shares of common stock					2,914,000
Net loss					(12,064,700)
Balance at end of period at Jun. 30, 2023	$ 1	$ 1,176	107,716,223	(114,012,200)	(6,294,800)
Balance at end of period (in shares) at Jun. 30, 2023	8,000	1,176,260
Balance at beginning of period at Mar. 31, 2023		$ 979	99,106,521	(107,247,800)	(8,140,300)
Balance at beginning of period (in shares) at Mar. 31, 2023		979,243
Common stock discount amortization			85,900		85,900
Warrants underlying common stock issuance			(85,900)		(85,900)
Commitment shares issuance from standby equity purchase agreement		$ 197	658,903		659,100
Commitment shares issuance from standby equity purchase agreement (in shares)		197,017
Issuance of preferred stock	$ 1		7,999,999		8,000,000
Issuance of preferred stock (in shares)	8,000
Stock issuance costs			(84,600)		(84,600)
Stock compensation expense			35,400		35,400
Net loss				(6,764,400)	(6,764,400)
Balance at end of period at Jun. 30, 2023	$ 1	$ 1,176	$ 107,716,223	$ (114,012,200)	$ (6,294,800)
Balance at end of period (in shares) at Jun. 30, 2023	8,000	1,176,260

CONVERTIBLE DEBT (Tables)

6 Months Ended

Jun. 30, 2023

CONVERTIBLE DEBT

Schedule of convertible debt


	June 30, 2023		December 31, 2022
Senior Secured Convertible Promissory Note, maturing December 12, 2023	$	—	$	4,000,000
Senior Secured Convertible Promissory Note, maturing March 28, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing April 25, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing May 24, 2024		2,000,000		—
Senior Secured Convertible Promissory Note, maturing June 26, 2024		2,400,000		—
Total Convertible Promissory Note	$	8,400,000	$	4,000,000
Less: unamortized debt issuance costs		(364,700)		(190,100)
Convertible Promissory Note, net	$	8,035,300	$	3,809,900

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2023	Aug. 11, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Jun. 30, 2023
Entity File Number	001-39619
Entity Registrant Name	Kiromic BioPharma, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-4762913
Entity Address, Address Line One	7707 Fannin Street
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Houston
Entity Address State Or Province	TX
Entity Address, Postal Zip Code	77054
City Area Code	832
Local Phone Number	968-4888
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	KRBP
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	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		1,176,260
Entity Central Index Key	0001792581
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Condensed Consolidated Balance Sheets
Preferred stock, par value ( in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, authorized	60,000,000	60,000,000
Preferred stock, issued	8,000	0
Preferred stock, outstanding	8,000	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, authorized	300,000,000	300,000,000
Common stock, issued	1,176,260	648,384
Common stock, outstanding	1,176,260	648,384

PROPERTY AND EQUIPMENT (Details) - USD ($)	3 Months Ended		6 Months Ended
PROPERTY AND EQUIPMENT (Details) - USD ($)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	$ 10,867,600		$ 10,867,600		$ 10,837,200
Less: Accumulated depreciation	(3,805,800)		(3,805,800)		(2,700,300)
Total	7,061,800		7,061,800		8,136,900
Depreciation	549,600	$ 399,100	1,105,400	$ 581,900
Equipment
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	3,041,900		3,041,900		3,041,900
Leasehold improvements
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	7,298,500		7,298,500		7,298,500
Office furniture, fixtures, and equipment
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	137,300		137,300		137,300
Software
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	359,500		359,500		$ 359,500
Construction in progress
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	$ 30,400		$ 30,400

STOCK-BASED COMPENSATION - Restricted Stock Units (Details) - Restricted Stock Units - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Stock Incentive Plan 2017
Restricted stock units
Stock compensation expense	$ 29,600	$ 4,300	$ 29,600	$ 9,200
Unrecognized stock compensation expenses	$ 96,600		$ 96,600
Restricted stock unit activity
Nonvested RSUs at beginning of year			650	17,028
Vested			(251)	(356)
Cancelled and forfeited			(11)	(11,191)
Nonvested RSUs at June 30	388	5,481	388	5,481
Weighted average grant day fair value per share
Nonvested RSUs at beginning of year			$ 259.50	$ 374.40
Vested			255.85	259.20
Cancelled and forfeited			260.10	383.70
Nonvested RSUs at June 30	$ 285.36	$ 362.70	$ 285.36	$ 362.70
Stock Incentive Plan 2017 \| Research and development
Restricted stock units
Stock compensation expense	$ 15,100	$ 1,900	$ 15,100	$ 13,900
Stock Incentive Plan 2017 \| General and administrative
Restricted stock units
Stock compensation expense	14,500	2,400	14,500	(4,700)
Stock Incentive Plan 2021
Restricted stock units
Stock compensation expense	$ 5,800	$ 37,300	$ 26,500	$ 55,500
Restricted stock unit activity
Nonvested RSUs at beginning of year			684	2,068
Granted			36,910
Vested			(13,425)
Cancelled and forfeited			(668)	(131)
Nonvested RSUs at June 30	23,501	1,937	23,501	1,937
Weighted average grant day fair value per share
Nonvested RSUs at beginning of year			$ 133.20	$ 165.60
Granted			0.62
Vested			0.62
Cancelled and forfeited			126.60	126.60
Nonvested RSUs at June 30	$ 20.41	$ 168.30	$ 20.41	$ 168.30
Stock Incentive Plan 2021 \| Research and development
Restricted stock units
Stock compensation expense	$ 3,900	$ 17,400	$ 11,800	$ 25,700
Stock Incentive Plan 2021 \| General and administrative
Restricted stock units
Stock compensation expense	$ 1,900	$ 19,900	$ 14,700	$ 29,800

STOCK-BASED COMPENSATION

6 Months Ended

Jun. 30, 2023

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

11.STOCK-BASED COMPENSATION

2017 Stock Incentive Plan—Restricted Stock Units

The following table summarizes the activity for all RSUs outstanding under the 2017 Plan at:


	2023			2022
		Weighted Average			Weighted Average
		Grant Date			Grant Date
		Fair Value			Fair Value
	Shares	Per Share		Shares	Per Share
Nonvested RSUs at beginning of period	650	$	259.50	17,028	$	374.40
Granted	—		—	—		—
Vested	(251)		255.85	(356)		259.20
Cancelled and forfeited	(11)		260.10	(11,191)		383.70
Nonvested RSUs at June 30	388	$	285.36	5,481	$	362.70

Total stock compensation expense recognized from stock-based compensation awards classified as restricted stock units were recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2023 and 2022, as follows:


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	15,100	$	1,900	$	15,100	$	13,900
General and administrative		14,500		2,400		14,500		(4,700)
Total	$	29,600	$	4,300	$	29,600	$	9,200

2017 Stock Incentive Plan— Stock Options

The following table summarizes the activity for all stock options outstanding at June 30, 2023 under the 2017 Plan:


	2023			2022
		Weighted			Weighted
		Average			Average
		Exercise			Exercise
	Shares	Price		Shares	Price
Options outstanding at beginning of period	11,286	$	254.40	12,697	$	257.10
Granted	—		—	—		—
Exercised	—		—	—		—
Cancelled and forfeited	(5,433)		215.35	(1,401)		275.70
Balance at June 30	5,853	$	285.36	11,296	$	254.70
Options exercisable at June 30:	5,853	$	285.36	11,165	$	255.00

In addition, the weighted average remaining contractual life for the options is 4.43 years and 4.93 years as of June 30, 2023 and December 31, 2022, respectively. The options have no intrinsic value as of June 30, 2023 or December 31, 2022, respectively.

Total stock compensation expense recognized from stock-based compensation awards classified as stock options were recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2023 and 2022 as follows:


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	—	$	3,000	$	—	$	52,000
General and administrative		—		7,000		—		15,000
Total	$	—	$	10,000	$	—	$	67,000

As of June 30, 2023, there was no unrecognized stock compensation expense related to unvested stock options.

As of June 30, 2023, there was $96,600 unrecognized stock compensation expense related to unvested restricted stock units.

2021 Stock Incentive Plan—Restricted Stock Units

The following table summarizes the activity for all RSUs outstanding at June 30, 2023 and 2022 under the 2021 Plan:


	2023			2022
		Weighted Average			Weighted Average
		Grant Date			Grant Date
		Fair Value			Fair Value
	Shares	Per Share		Shares	Per Share
Nonvested RSUs at beginning of period	684	$	133.20	2,068	$	165.60
Granted	36,910		0.62	—		—
Vested	(13,425)		0.62	—		—
Cancelled and forfeited	(668)		126.60	(131)		126.60
Nonvested RSUs at June 30	23,501	$	20.41	1,937	$	168.30


	Three Months Ended				Six Months Ended
	2023		2022		2023		2022
Research and development	$	3,900	$	17,400	$	11,800	$	25,700
General and administrative		1,900		19,900		14,700		29,800
Total	$	5,800	$	37,300	$	26,500	$	55,500

The vested outstanding restricted stock units have not been released to grantees as of June 30, 2023, but they were included in calculation of weighted average common shares outstanding, basic and diluted (See Note 3, Net Loss Per Share of Common Stock). The Company plans to release these shares to the grantees before the end of the year. Since there is a possibility that any portion of those shares could be sold as part of the release, the shares will be released in compliance with the Company’s insider trading policy when there is an open trading window and grantees are not in possession of any material non-public information.

2021 Stock Incentive Plan — Stock Options

The following table summarizes the activity for all stock options outstanding at June 30, 2023 under the 2021 Plan:


	2023			2022
		Weighted			Weighted
		Average			Average
		Exercise			Exercise
	Shares	Price		Shares	Price
Options outstanding at beginning of period	21,420	$	12.90	—	$	—
Granted	—		—	24,480		12.90
Exercised	—		—	—		—
Cancelled and forfeited	(9,180)		12.90	—		—
Balance at June 30	12,240	$	12.90	24,480	$	12.90
Options exercisable at June 30:	12,240	$	12.90	12,240	$	12.90
Weighted average grant date fair value for options granted during the year:		$	—		$	10.80

In addition, the stock options had weighted average remaining contractual life of 4.93 years. There was no stock compensation expense during the six months ended June 30, 2023 and June 30, 2022, respectively.