0001558370-24-003520 | 10-K | XBRL Viewer

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

Condensed Consolidated Statements of Stockholders' Deficit - 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			344,800		344,800
Warrants underlying common stock issuance			(344,800)		(344,800)
Released restricted stock units		$ 35	(35)
Released restricted stock units (in shares)		35,257
Commitment shares issuance from standby equity purchase agreement		$ 20	(20)
Commitment shares issuance from standby equity purchase agreement (in shares)		20,111
Letter agreement share issuance		$ 33	(33)
Letter agreement share issuance (in shares)		33,333
Conversion of subordinated convertible promissory notes into shares of common stock		$ 44	399,356		399,400
Conversion of subordinated convertible notes into shares of common stock (in shares)		43,399
Stock compensation expense			1,237,100		1,237,100
Net Income (Loss)				(34,731,000)	(34,731,000)
Balance at end of period at Dec. 31, 2022		$ 648	96,172,152	(101,947,500)	(5,774,700)
Balance at end of period (in shares) at Dec. 31, 2022		648,384
Common stock discount amortization			344,700		344,700
Warrants underlying common stock issuance			(344,700)		(344,700)
Released restricted stock units		$ 84	(84)
Released restricted stock units (in shares)		83,973
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
Conversion of subordinated convertible promissory 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
Issuance of preferred stock	$ 2		13,999,998		14,000,000
Issuance of preferred stock (in shares)	14,000
Stock issuance costs			(111,200)		(111,200)
Stock compensation expense			141,300		141,300
Net Income (Loss)				(20,949,300)	(20,949,300)
Balance at end of period at Dec. 31, 2023	$ 2	$ 1,258	$ 113,774,740	$ (122,896,800)	$ (9,120,800)
Balance at end of period (in shares) at Dec. 31, 2023	14,000	1,258,460

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE

12 Months Ended

Dec. 31, 2023

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE

7.SENIOR SECURED CONVERTIBLE PROMISSORY NOTE

The Company began issuing senior secured convertible promissory notes (each a “CPN” and together the “Notes”) payable to a private accredited investor (the “Investor”) during 2022. The Company has continued to issue notes to the Investor during 2023.

Through December 31, 2023, the Company has issued to the Investor thirteen notes totaling $28,000,000, of which $24,000,000 were issued during year ended December 31, 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. As of December 31, 2023, there were six outstanding notes. Two outstanding notes with a value of $2,400,000, were each issued with a conversion price of $6.50. Two outstanding notes with a value of $2,400,000 were each issued with a conversion price of $5.00. One outstanding note with a value of $2,400,000 was issued with a conversion price of $2.50, and one outstanding note with a value of $2,000,000 was issued with a conversion price of $2.50.

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 and July 2023, the Company executed an exchange agreement to convert $8,000,000 and $6,000,000 of the senior secured promissory notes principal into shares of preferred stock, respectively. See Note 10 – Stockholder’s Deficit for further discussion.


	December 31, 2023		December 31, 2022
Senior secured convertible promissory note, maturing December 12, 2023	$	—	$	4,000,000
Senior secured convertible promissory note, maturing June 26, 2024		2,400,000		—
Senior secured convertible promissory note, maturing July 25, 2024		2,400,000		—
Senior secured convertible promissory note, maturing August 25, 2024		2,400,000		—
Senior secured convertible promissory note, maturing September 27, 2024		2,400,000		—
Senior secured convertible promissory note, maturing November 2, 2024		2,400,000		—
Senior secured convertible promissory note, maturing December 12, 2024		2,000,000		—
Total convertible promissory note	$	14,000,000	$	4,000,000
Less: unamortized debt issuance costs		—		(190,100)
Convertible promissory note, net	$	14,000,000	$	3,809,900

As part of the recognition of the Credit Memo, our deferred financing costs related to the convertible debt were derecognized. See Note 1 for more information.

- 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.

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+ Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Nonvested Stock Options and Warrants (Details)	12 Months Ended
	Dec. 31, 2023 segment $ / shares	Jul. 02, 2021 $ / shares	Oct. 15, 2020 $ / shares
Nonvested Stock Options
Expected dividend yield	0.00%
Warrants
Number of reportable segment \| segment	1
Restricted Stock Units
Nonvested Stock Options
Period, after vesting, during which shares are released to grantee	60 days
Employee Stock Option
Nonvested Stock Options
Expiration period	10 years
Minimum \| Restricted Stock Units
Nonvested Stock Options
Vesting period	6 months
Maximum \| Restricted Stock Units
Nonvested Stock Options
Vesting period	12 months
Annual Vesting Conditions
Nonvested Stock Options
Vesting period	4 years
Monthly Vesting Conditions \| Minimum
Nonvested Stock Options
Vesting period	10 months
Monthly Vesting Conditions \| Maximum
Nonvested Stock Options
Vesting period	48 months
Common Stock Warrants - Representative
Nonvested Stock Options
Expected dividend yield	0.00%
Common Stock Warrants - Representative \| Initial Public Offering
Warrants
Share price	$ 12.00
Warrant exercise price	15.00		$ 450.00
Common Stock Warrants - Representative \| Public Offering
Warrants
Share price	5.00
Warrant exercise price	$ 6.25	$ 187.50

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2023
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

LEASES - Components of lease expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Operating leases
Operating lease cost	$ 716,100	$ 663,100
Weighted-average remaining lease term	2 years 4 months 2 days	3 years 4 months 2 days
Weighted-average discount rate	7.12%	7.12%
Research and development
Operating leases
Operating lease cost	$ 393,900	$ 473,200
General and administrative
Operating leases
Operating lease cost	$ 322,200	$ 189,900

STOCKHOLDERS' EQUITY - Standby Equity Purchase Agreement Financing (Details)					12 Months Ended
	Jun. 02, 2023 USD ($) $ / shares shares	May 24, 2023 USD ($) $ / shares shares	Oct. 31, 2022 USD ($) shares	Oct. 13, 2022 USD ($) D $ / shares shares	Dec. 31, 2023 USD ($) $ / shares	Dec. 31, 2022 USD ($) $ / shares
Stockholder's equity (Deficit)
Common stock, par value (in dollars per share) \| $ / shares					$ 0.001	$ 0.001
Stock-based compensation expense					$ 141,300	$ 1,237,100
Proceeds from Issuance of Common Stock					$ 659,100
Standby Equity Purchase Agreement Financing
Stockholder's equity (Deficit)
Common stock, par value (in dollars per share) \| $ / shares				$ 0.001
Term of anniversary				24 months
Percentage of market price				95.00%
Maximum beneficial ownership percentage				9.99%
Percentage of outstanding common stock on the date of agreement				19.90%
Threshold value of applicability of exchange cap				$ 9.33
Number of trading days proceeding the date of agreement \| D				5
Amount of cash outflow for structuring fee				$ 10,000
Commitment shares issuance from standby equity purchase agreement (in shares) \| shares				20,111
Amount of dividing factor for calculation of additional number of common stock to be issued				$ 120,000
Stock-based compensation expense			$ 298,000	$ 193,665		$ 491,665
Number of trading days prior to the date of delivery \| D				5
Shares issued for services rendered \| shares			33,333
Shares issued \| shares	100,000	97,000
Stock purchase price \| $ / shares	$ 2.82	$ 3.89
Proceeds from Issuance of Common Stock	$ 282,100	$ 377,000
Standby Equity Purchase Agreement Financing \| Maximum
Stockholder's equity (Deficit)
Commitment amount				$ 8,000,000

INCOME TAXES - Net Operating Loss Carryforward (Details) - U.S. - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Operating loss carryforwards
Net operating loss carryforwards	$ 77,037,900	$ 60,328,200
Net operating loss carryforwards subject to expiration beginning in 2036	6,126,173
Net operating loss carryforwards which may be carried forward indefinitely until fully utilized	$ 70,911,727

PROPERTY AND EQUIPMENT, NET (Details) - USD ($)	12 Months Ended
PROPERTY AND EQUIPMENT, NET (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	$ 11,096,500	$ 10,837,200
Less: Accumulated depreciation	(4,921,400)	(2,700,300)
Total	6,175,100	8,136,900
Depreciation	2,221,100	1,673,400
Equipment
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	3,126,300	3,041,900
Leasehold improvements
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	7,372,100	7,298,500
Office furniture, fixtures, and equipment
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	137,300	137,300
Software
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	359,500	$ 359,500
Construction in progress
PROPERTY AND EQUIPMENT
Property, plant and equipment, gross	$ 101,300

Pay vs Performance Disclosure - USD ($)	12 Months Ended
Pay vs Performance Disclosure - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ (20,949,300)	$ (34,731,000)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 34: http://www.xbrl.org/2003/role/disclosureRef
-Topic 205
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483499/205-20-50-7

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-Topic 230
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 28
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482740/230-10-45-28

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482790/220-10-45-1A

Reference 37: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482790/220-10-45-1B

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-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
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-Topic 942
-SubTopic 220
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483589/942-220-S99-1

+ Details

INCOME TAXES - Tax Rate Reconciliation (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
INCOME TAXES
Income tax provision	$ 0	$ 0
Reconciliation of the statutory federal income tax rate to the effective tax rate
Federal income tax at statutory rates	21.00%	21.00%
Change in valuation allowance	(21.00%)	(21.00%)

- Definition

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

+ References + Details

COMMITMENTS AND CONTINGENCIES

12 Months Ended

Dec. 31, 2023

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

8.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 December 31, 2023 and 2022, the Company has not incurred any milestone or royalty liabilities related to these license agreements.

Legal Proceedings

Jason Terrel Claim

On March 22, 2021, Jason Terrell (“Terrell”), a former consultant and 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 we are obligated to issue him (i) options to purchase 16,667 shares of our common stock at a price of $15.00 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 our 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.

We dispute 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 Delaware Supreme Court also rejected Terrell’s argument that the waiver clause in the third options agreement (which, according to the Company, superseded and extinguished unexercised options under the prior options agreements) was unconscionable.

Pursuant to a stipulated scheduling order, the parties submitted supplemental letter briefs to the Chancery Court in mid-August 2023, addressing the impact of the Opinion on the Company’s motion to dismiss. Thereafter, the Chancery Court notified the parties that it had received the supplemental letter briefs and would take the matter under advisement without holding oral argument.

On January 31, 2024, the Chancery Court issued a letter opinion that dismissed Terrell’s claims based on the contract-interpretation grounds the Company originally advanced back in 2021, as well as the Delaware Supreme Court’s determination that the third options agreement was not unconscionable. The parties are required to submit a stipulated final order to the Chancery Court, reflecting the outcome of the Chancery Court’s letter opinion, for approval. Should Terrell appeal the dismissal to the Delaware Supreme Court, the Company intends to vigorously argue that the Chancery Court’s dismissal should be affirmed.

Sabby and Empery Claims

On February 2, 2022, 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.”

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.

This settlement loss resulted in an expense charged as a separate line item within Other expenses on the consolidated statement of operations for $3,463,000 for the year ended December 31, 2022. 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 year ended December 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.

Karp Class Action

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’ claims discussed above and 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 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.

Podmore Class Action

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”. Please refer to the Settlement of the Class Action described more fully below.

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. We subsequently reached agreement with the plaintiffs in the Class Action on all settlement materials and terms including with respect to payment of up to $2,300,000 and, on September 29, 2023, counsel for plaintiffs submitted the proposed settlement materials to the Court for approval. Of this amount, insurance will cover $570,000, resulting in a net settlement of $1,730,000 owed by the Company. As of December 31, 2023, we have paid $1,282,500 to the plaintiffs, with a remaining balance of $447,500 to be payable according to the term sheet, and recorded in accrued expenses and other current liabilities.

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 and cash flows.

Company 401(k) Plan— During the year ended December 31, 2022, the Company started a defined contribution 401(k) plan covering substantially all full-time employees. Employees are permitted to make voluntary contributions, which the Company matches up to a certain percentage. The plan contribution expense was $220,500 and $291,800 for the years ended December 31, 2023 and December 31, 2022, respectively. These amounts are allocated between research and development and general and administrative expenses in the income statement.

LEASES - Balance sheet disclosures (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Leases
Operating lease right-of-use asset	$ 1,542,500	$ 2,117,300
Operating lease liability - short term	(631,000)	(584,400)
Operating lease liability - long term	(911,500)	(1,544,900)
Total lease liabilities	$ (1,542,500)	$ (2,129,300)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of estimated useful lives of property and equipment


Asset Description		Estimated Lives
Laboratory Equipment		3 - 8
Leasehold Improvements		1 - 7
Office Furniture, Fixtures, and Equipment		5
Software		3 - 5

ORGANIZATION

12 Months Ended

Dec. 31, 2023

ORGANIZATION

ORGANIZATION

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 allogeneic Gamma Delta T-cell therapy company featuring unique, proprietary, end-to-end bioinformatic, AI targeting, and manufacturing technologies to address solid tumors. Our end-to-end approach consists of target discovery and validation, product development, and on-site current good manufacturing practices (“cGMP”), which we believe will allow us to leverage a new framework for the next generation of cell therapies.

From a development standpoint, the Company utilizes innovative engineered and non-engineered GDT manufacturing technologies and is developing proprietary, virus-free gene editing tools, to develop novel therapies for solid tumors that we believe will be effective and cost-efficient. The Procel, Isocel, and Deltacel product platform candidates consist of allogeneic cell therapy candidates that are currently in the preclinical development stage. Our Procel product candidate consists of engineered GDTs targeting PD-L1. Our Isocel product candidate consists of engineered GDTs targeting Mesothelin Isoform 2 positive tumors (“Iso-Meso”). Our Deltacel product candidate consists of non-engineered GDTs that have been expanded, enriched, and activated ex-vivo through a proprietary process, and are used to treat solid tumors regardless of the specific tumor antigen expression. Procel consists of engineered GDTs targeting PD-L1 positive tumors, while Isocel consists of engineered GDTs targeting solid tumors expressing a tumor-specific variant (Isoform) of Mesothelin (“Iso-Meso”).

We currently have three product candidates: 1) DeltacelÔ, non-engineered GDTs, expanded and activated with proprietary technology; 2) Isocel^TM, GDTs engineered with an anti-Mesothelin isoform Chimeric Antigen Receptor; and 3) ProcelÔ, GDTs engineered with a PD-1 switch receptor.

The Company is developing a novel and virus-independent engineering method, which will result in the submission of new IND applications for clinical programs. 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. Depending on evidence from preclinical studies, we may limit the new IND submission to two instead of four: one for Isocel and one for Procel. Refer to Item 1- Business for more information.

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.

Credit Memo — During the year ended December 31, 2023, the Company entered into an engagement letter with a vendor whereby we renegotiated the terms of services to be received and the amounts to be paid for such services. As part of this negotiation, the Company obtained a credit memo (the “Credit Memo”) of $1.10 million against the amounts outstanding as of June 30, 2023. This credit memo has been recognized as follows:

●

Reduction to accounts payable of $1.10 million

●

Reduction of deferred financing costs of $0.36 million

●

Increase to other income of $0.74 million

Notice of Delisting — On September 12, 2023, the Company received written notice from the Nasdaq Stock Market, LLC (“Nasdaq”) that it would delist the Company’s shares of common stock from the Nasdaq Capital Market upon the opening of trading on September 14, 2023. As of this date, the Company’s common stock was delisted from the NASDAQ and began trading on the OTC Pink Sheets. On November 17, 2023, the Company successfully uplisted to and began trading on the OTCQB exchange. The transition of the Company’s stock to the OTCQB exchange has not had any impact on its day-to-day operations, nor does the Company anticipate an impact to its operations.

Going Concern —These 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 $21,225,300 for the year ended December 31, 2023, and an accumulated deficit of $122,896,800 as of December 31, 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 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, additional funding from current or new investors. However, there can be no assurance that the Company will be able to secure such additional 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 financing sufficient 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 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.

STOCK-BASED COMPENSATION - Restricted Stock Units (Details) - Restricted Stock Units - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Stock Incentive Plan 2017
Restricted stock units
Stock compensation expense	$ 58,500	$ 61,100
Unrecognized stock compensation expenses	$ 255,800
Restricted stock unit activity
Nonvested RSUs at beginning of period	650	17,028
Vested	(273)	(433)
Cancelled and forfeited	(57)	(15,945)
Nonvested RSUs at December 31	320	650
Weighted average grant day fair value per share
Nonvested RSUs at beginning of period	$ 259.50	$ 374.40
Vested	255.85	297.00
Cancelled and forfeited	260.10	382.50
Nonvested RSUs at December 31	$ 285.36	$ 259.50
Stock Incentive Plan 2017 \| Research and development
Restricted stock units
Stock compensation expense	$ 26,400	$ 38,900
Stock Incentive Plan 2017 \| General and administrative
Restricted stock units
Stock compensation expense	32,100	22,200
Stock Incentive Plan 2021
Restricted stock units
Stock compensation expense	$ 82,600	$ 358,500
Restricted stock unit activity
Nonvested RSUs at beginning of period	684	2,068
Granted	138,343	24,610
Vested	(83,700)	(25,241)
Cancelled and forfeited	(621)	(753)
Nonvested RSUs at December 31	54,706	684
Weighted average grant day fair value per share
Nonvested RSUs at beginning of period	$ 133.20	$ 165.60
Granted	1.45	12.30
Vested	0.23	33.00
Cancelled and forfeited	126.60	206.40
Nonvested RSUs at December 31	$ 1.56	$ 133.20
Stock Incentive Plan 2021 \| Research and development
Restricted stock units
Stock compensation expense	$ 37,700	$ 56,300
Stock Incentive Plan 2021 \| General and administrative
Restricted stock units
Stock compensation expense	$ 44,900	$ 302,200

NET LOSS PER COMMON SHARE - Computation of basic and diluted earnings per share (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Net loss per common share
Net Income (Loss)	$ (20,949,300)	$ (34,731,000)
Less: Initial Public Offering Common Stock discount amortization	(99,900)	(100,000)
Less: Public offering Common Stock discount amortization	(244,800)	(244,800)
Less: Undeclared dividends attributable to preferred stock	(2,205,500)
Net loss attributable to common shareholders, basic	$ (23,499,500)	$ (35,075,800)
Weighted average common shares outstanding, basic	1,097,630	544,475
Weighted average preferred shares outstanding, basic	8,773
Weighted average common shares outstanding, diluted	1,097,630	544,475
Weighted average preferred shares outstanding, diluted	8,773
Net loss per common share, basic	$ (12.59)	$ (64.42)
Net loss per preferred share, basic	(1,103.73)
Net loss per common share, diluted	(12.59)	$ (64.42)
Net loss per preferred share, diluted	$ (1,103.73)
Preferred Stock
Net loss per common share
Net loss attributable to common shareholders, basic	$ (9,682,600)
Net loss attributable to common shareholders, diluted	$ (9,682,600)
Weighted average preferred shares outstanding, basic	8,773
Weighted average preferred shares outstanding, diluted	8,773
Net loss per preferred share, basic	$ (1,103.73)
Net loss per preferred share, diluted	$ (1,103.73)
Common Stock
Net loss per common share
Net loss attributable to common shareholders, basic	$ (13,816,900)	$ (35,075,800)
Net loss attributable to common shareholders, diluted	$ (13,816,900)	$ (35,075,800)
Weighted average common shares outstanding, basic	1,097,630	544,475
Weighted average common shares outstanding, diluted	1,097,630	544,475
Net loss per common share, basic	$ (12.59)	$ (64.42)
Net loss per common share, diluted	$ (12.59)	$ (64.42)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2.	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”). All intercompany balances were eliminated upon consolidation. Operating results for the year ended December 31, 2023, are not necessarily indicative of results to be expected for any future year.

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.

Property and Equipment—Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets ranging from 1 to 8 years. Major replacements and improvements are capitalized as leasehold improvements, while general repairs and maintenance are expensed as incurred. Estimated useful lives of leasehold improvements are the shorter of the remaining lease term or the estimated useful economic life of the specific asset.


Asset Description		Estimated Lives
Laboratory Equipment		3 - 8
Leasehold Improvements		1 - 7
Office Furniture, Fixtures, and Equipment		5
Software		3 - 5

Internal Use Software Development Costs—The Company capitalizes certain costs incurred to develop internal use software. All costs incurred that relate to planning and post-implementation phases of development are expensed as incurred. Costs incurred in the development and implementation phases are capitalized and amortized over the estimated life of the software, generally five years. The Company capitalized software development costs of approximately $91,500 and $107,000 for the years ended December 31, 2023 and 2022, respectively, which are recorded in property and equipment.

Impairment of Long-Lived Assets—The Company reviews its long-lived assets, including property and equipment, for impairment indicators. If indicators are noted, the Company compares the carrying amount of the asset to its estimated undiscounted cash flows. If the carrying amount exceeds its estimated undiscounted cash flows, an impairment loss is recognized to adjust the long-lived asset to fair value. There have been no impairment losses on the Company’s long-lived assets since inception.

Comprehensive Loss—Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For all periods presented, there was no difference between net loss and comprehensive loss.

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 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 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 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 Accounting Standard Codification (“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 consolidated statements of operations. No such interest or penalties were recognized during the years ended December 31, 2023 and 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 pre-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.

Fair Value Measurements— The carrying value of our cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses, other current liabilities and debt approximate their fair value.

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In estimating the fair value of an asset or a liability, we take into account the characteristics of the asset or liability if market participants would take those characteristics into account when pricing the asset or liability at the measurement date.

We account for financial instruments in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures. ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below:

Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

Level 2—Quoted prices in non-active markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices, and inputs that are not directly observable but are corroborated by observable market data.

Level 3—Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.

There were no changes in the fair value hierarchy leveling during the years ended December 31, 2023 or 2022.

Nonvested Stock Options and Restricted Stock Units—Pursuant to the Company’s 2017 Stock Incentive Plan (the “2017 Plan”) and the Omnibus 2021 Equity Incentive Plan (the “2021 Plan”), the Company has the ability to issue a variety

of share-based payments and incentives to board members, employees, and non-employees through grants of nonvested stock options and restricted stock units (“RSUs”).

The vesting conditions for stock options and RSUs include annual and monthly vesting. Annual vesting conditions are for four years. Monthly vesting conditions range from 10 to 48 months. When nonvested options are vested, they become exercisable over a 10-year period from grant date.

The vesting conditions for RSUs include cliff vesting conditions. Certain RSUs vest with a range of 6 to 12 months following the expiration of employee lock-up agreements. Certain RSUs vest based on the later of achievement of key milestones or the expiration of employee lock-up agreements. When nonvested RSUs are vested, they are released to the grantee within sixty days.

Stock-Based Compensation—The Company records stock compensation expense related to the 2017 Equity Incentive Plan (the “2017 Plan”) and the Omnibus 2021 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 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 U.S. 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. The closing price listed on the OTCQB Capital Market or previously the NASDAQ Capital Market for the Company’s common stock on the date of the grant is used as the common stock valuation.

Warrants Underlying Shares from common stock offerings—The Company records warrants to purchase shares of common stock underlying shares of common stock offerings in accordance with ASC 470, Debt with conversion and other options. The fair value of the warrants were estimated on the offering dates using the Black-Scholes option- valuation model. The calculation of warrants requires that we make assumptions and judgments about the variables used in the Black-Scholes option-valuation model, including the fair value of our common stock, expected term, expected volatility of the underlying common stock, risk-free interest rate, and exercise price.

The Company estimated the fair value of warrants underlying shares of offering common stock using the Black-Scholes option-valuation model and the assumptions used to value such warrants are determined as follows:

Expected Term. The expected term represents the period that warrants are expected to be outstanding. The expected term was calculated by taking the average of the vesting period and contract period.

Risk-Free Interest Rate. The Company based the risk-free interest rate used in the Black-Scholes option-valuation model on the implied yield available on U.S. Treasury zero-coupon issues with a term equivalent to that of the expected term of the warrants.

Volatility. The Company determined the price volatility based on the historical volatilities of industry peers as the Company had one day of trading history as of the IPO date. 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 the Company’s 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 current expectations about anticipated dividend policy. To date, the Company has not declared any dividends and, therefore, it used an expected dividend yield of zero.

Common Stock Valuations. The fair value of common stock when the warrants were issued is equal to the IPO common stock issuance price of $12.00 per share, and July 2021 offering issuance price of $5.00 per share.

Exercise Price. The representative warrants’ exercise price to purchase common stock is $15.00 per share, and $6.25 per share for the IPO common stock issuance and July 2021 offering issuance, respectively.

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 February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842), which requires lessees to recognize the following for all leases (with the exception of short-term leases) at the commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. In July 2018, the FASB issued ASU 2018-11 to amend certain aspects of Topic 842. These amendments provide entities with an additional (and optional) transition method to adopt Topic 842. Under this transition method, an entity initially applies the transition requirements in Topic 842 at that Topic’s effective date with the effects of initially applying Topic 842 recognized as a cumulative effect adjustment to the opening balance of retained earnings (or other components of equity or net assets, as appropriate) in the period of adoption. On October 16, 2019, the FASB changed the effective date of this standard applicable to the Company as an emerging growth company to January 1, 2022. Accordingly, Topic 842 is effective for the Company beginning in the first quarter of 2022. The Company notes that adopting the new standard resulted in recording a lease liability and right-of-use asset associated with the Company’s facility lease agreement and subsequent amendments thereto totaling $2,232,700, as of January 1, 2022.

In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” The ASU, including subsequently issued updates, offers temporary optional expedients and exceptions for applying U.S. GAAP to modifications to agreements such as loans, debt securities, derivatives, and borrowings which reference LIBOR or another reference rate that will partially discontinue after December 31, 2021 and fully cease by June 30, 2023. The expedients and exceptions provided by the standard do not apply to modifications made and hedging relationships entered into or evaluated after that, except for hedging relationships existing as of the phase-out date that an entity has elected certain optional expedients for and are retained through the end of the hedging relationship. The ASU is effective until the replacement for LIBOR is completed. The interest rate on the Company’s senior secured convertible promissory note is determined by the investor and does not fluctuate with LIBOR. As such, the Company’s adoption of this standard in fiscal year 2023 did not have a significant impact on the consolidated financial statements and related disclosures.

In November 2023, the FASB issued ASU 2023-07, “Improvements to Reportable Segment Disclosures (Topic 280)”. ASU 2023-07 modifies reportable segment disclosure requirements, primarily through enhanced disclosures about segment expenses categorized as significant or regularly provided to the Chief Operating Decision Maker (CODM). In addition, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, and contain other disclosure requirements. The purpose of the amendments is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. This ASU is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024, with early adoption permitted. The Company currently operates as one reportable segment and does not believe there will be a material impact on the related disclosures in the consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures (Topic 740)”. ASU 2023-09 requires enhanced disclosures on income taxes paid, adds disaggregation of continuing operations before income taxes between foreign and domestic earnings and defines specific categories for the reconciliation of jurisdictional tax rate to effective tax rate. This ASU is effective for fiscal years beginning after December 15, 2024, and can be applied on a prospective basis. The Company is currently evaluating the impact this new standard will have on the related disclosures in the consolidated financial statements.

PROPERTY AND EQUIPMENT, NET

12 Months Ended

Dec. 31, 2023

PROPERTY AND EQUIPMENT, NET

PROPERTY AND EQUIPMENT, NET

4.	PROPERTY AND EQUIPMENT, NET

Property and equipment, net consisted of the following at:


	December 31, 2023		December 31, 2022
Equipment	$	3,126,300	$	3,041,900
Leasehold improvements		7,372,100		7,298,500
Office furniture, fixtures, and equipment		137,300		137,300
Software		359,500		359,500
Construction in progress		101,300		—
		11,096,500		10,837,200
Less: Accumulated depreciation		(4,921,400)		(2,700,300)
Total	$	6,175,100	$	8,136,900

Depreciation expense was $2,221,100 and $1,673,400 for the years ended December 31, 2023 and 2022, respectively. Depreciation expense is allocated between research and development and general and administrative operating expenses on the consolidated statements of operations.

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE (Tables)

12 Months Ended

Dec. 31, 2023

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE

Schedule of convertible debt


	December 31, 2023		December 31, 2022
Senior secured convertible promissory note, maturing December 12, 2023	$	—	$	4,000,000
Senior secured convertible promissory note, maturing June 26, 2024		2,400,000		—
Senior secured convertible promissory note, maturing July 25, 2024		2,400,000		—
Senior secured convertible promissory note, maturing August 25, 2024		2,400,000		—
Senior secured convertible promissory note, maturing September 27, 2024		2,400,000		—
Senior secured convertible promissory note, maturing November 2, 2024		2,400,000		—
Senior secured convertible promissory note, maturing December 12, 2024		2,000,000		—
Total convertible promissory note	$	14,000,000	$	4,000,000
Less: unamortized debt issuance costs		—		(190,100)
Convertible promissory note, net	$	14,000,000	$	3,809,900

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recently issued accounting pronouncements (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2023	Dec. 31, 2022
Adoption of accounting pronouncements
Operating lease liability		$ 1,542,500	$ 2,129,300
Operating lease right-of-use asset		$ 1,542,500	2,117,300
Cumulative Effect, Period of Adoption, Adjustment
Adoption of accounting pronouncements
Operating lease liability			2,232,700
Operating lease right-of-use asset			$ 2,232,700
Accounting Standards Update [Extensible Enumeration]	us-gaap:AccountingStandardsUpdate201602Member

- Definition

Indicates amendment to accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
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+ Details

LEASES - Lease information (Details)					2 Months Ended	12 Months Ended
LEASES - Lease information (Details)	Jun. 05, 2023 USD ($) item	Aug. 02, 2022 USD ($) ft²	May 01, 2022 USD ($) ft² item	Aug. 01, 2021 ft²	Dec. 31, 2021 ft² item	Dec. 31, 2022
Leases
Lease, Practical Expedients, Package [true false]						true
Additional office space leased \| ft²		1,458	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 - Year one		$ 2,430
Monthly rent - Years one and two			$ 4,800
Monthly rent - Years two and three		2,490
Monthly rent - Years three and four			4,896
Monthly rent - Year five		$ 2,552	$ 5,000
Number of suites sublet \| item	3
Monthly rent on subleases	$ 6,444

STOCKHOLDERS DEFICIT

12 Months Ended

Dec. 31, 2023

STOCKHOLDERS DEFICIT

STOCKHOLDERS DEFICIT

10.STOCKHOLDERS’ DEFICIT

Stock—As of December 31, 2023 and 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 (1,258,460 and 648,384 shares issued and outstanding, respectively). Additionally, for the year ended December 31, 2023, the Company authorized the issuance of 14,000 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 and 6,000 shares of Series C Stock as part of the two Exchange agreements discussed below, of which 14,000 shares remain outstanding as of December 31, 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 December 31, 2023 and December 31, 2022, the outstanding Liquidation Preference of the Series C Stock is $16,205,500 and $0, 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 remaining 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 Agreements

On April 2, 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.

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.

Representative's Warrants— In connection with the IPO 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, which is 125% of the IPO price. 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 as of December 31, 2023 and 2022.

In connection with the 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, which is 125% of the IPO price. The Underwriters’ Warrants have a five-year term and were not exercisable prior to January 2, 2022. All of the Underwriters’ Warrants were outstanding as of December 31, 2023 and 2022. The warrants related to the Public Offering stock discount wll be fully amortized in April 2025.

Standby Equity Purchase Agreement Financing

On October 13, 2022, the Company entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, Ltd. (the “Investor”). Pursuant to the SEPA, the Company has the right to sell to the Investor up to $8,000,000 (the “Commitment Amount”) of its shares of common stock, par value $0.001 per share (“Common Stock”), at the Company’s request any time during the commitment period commencing on October 13, 2022 and terminating on the earliest of (i) the first day of the month following the 24-month anniversary of the SEPA or (ii) the date on which the Investor has paid for shares of Common Stock equal to the Commitment Amount.

The shares would be purchased at 95.0% of the Market Price (as defined in the agreement) and would be subject to certain limitations, including that the Investor could not purchase any shares that would result in it owning more than 9.99% of the outstanding Common Stock after such purchase (the "Ownership Limitation") or an aggregate of 19.9% of the outstanding Common Stock as of the date of the SEPA (the "Exchange Cap"). The Exchange Cap will not apply under certain circumstances, including to any sales of Common Stock under the SEPA that equal or exceed $9.33, representing the lower of (i) the closing price of the Common Stock as reflected on Nasdaq.com immediately preceding the date of the SEPA, or (ii) the average closing price of the Common Stock for the five trading days immediately preceding the date of the SEPA.

Pursuant to the SEPA, the Company also paid a subsidiary of the Investor, a structuring fee in the amount of $10,000 and issued to the Investor 20,111 shares of Common Stock as a commitment fee on October 13, 2022 (the “Commitment Shares”). The Company incurred a stock-based compensation expense of $193,665 related to this issuance. In the event of the Commitment Increase, the Company will issue to the Investor an additional number of shares of Common Stock determined by dividing $120,000 by the average of the daily VWAPs for the five trading days prior to the date of delivery by the Company of written notice of the Commitment Increase.

In connection with the SEPA agreement, on October 31, 2022, the Company entered into a letter agreement with an accredited investor (the “Investor”), pursuant to which the Company agreed to issue to the Investor 33,333 shares (the “Shares”) of the Company’s common stock in consideration of the Investor’s services to the Company in identifying investors. The Company issued the Shares to the Investor on October 31, 2022 and incurred a stock-based compensation expense of $298,000 related to this issuance. The Shares were issued in reliance upon the exemption from the registration requirements of the Securities Act, provided by Section 4(a)(2) of the Securities Act as sales by an issuer not involving any public offering.

Total compensation recognized in general and administrative expenses for the issuance of the Commitment Shares and the shares issued to the Investor totaled $491,665 during the year ended December 31, 2022.

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 equity.

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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

COMMITMENTS AND CONTINGENCIES - Legal proceedings (Details) - USD ($)					12 Months Ended
	Sep. 29, 2023	Sep. 26, 2022	Jul. 02, 2021	Mar. 22, 2021	Dec. 31, 2023	Dec. 31, 2022
Legal proceedings
Proceeds from issuance of common stock					$ 659,100
Subordinated convertible promissory note						$ 2,914,000
Litigation settlement loss, net					1,730,000	3,463,000
Accrued litigation liability					447,500
Company 401(K) Plan
401(K) plan contribution expense					$ 220,500	291,800
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				16,667
Stock option exercise price				$ 15.00
Jason Terrell - 2017 Non-employee Director Options Agreement
Legal proceedings
Number of stock options sought				16,667
Stock option exercise price				$ 5.10
Sabby Entities
Legal proceedings
Litigation settlement payments		$ 75,000
Convertible notes issued in settlement of legal proceedings		$ 1,656,720
Conversion price		$ 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					153,333
Sabby Entities \| Maximum
Legal proceedings
Maximum shares to be issued under conversion		180,000
Empery Entities
Legal proceedings
Litigation settlement payments		$ 75,000
Convertible notes issued in settlement of legal proceedings		$ 1,656,720
Conversion price		$ 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					163,268
Empery Entities \| Maximum
Legal proceedings
Maximum shares to be issued under conversion		180,000
Class Action \| Settled Litigation
Legal proceedings
Litigation settlement payments					$ 1,282,500
Portion of litigation settlement to be reimbursed by insurance carrier	$ 570,000
Litigation settlement loss, net	1,730,000
Class Action \| Settled Litigation \| Accrued expenses and other current liabilities
Legal proceedings
Accrued litigation liability					$ 447,500
Class Action \| Settled Litigation \| Maximum
Legal proceedings
Gross litigation settlement	$ 2,300,000

Condensed Consolidated Balance Sheets - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Current Assets:
Cash and cash equivalents	$ 3,204,000	$ 645,200
Prepaid expenses and other current assets	1,226,000	1,043,700
Total current assets	4,430,000	1,688,900
Property and equipment, net	6,175,100	8,136,900
Operating lease right-of-use asset	1,542,500	2,117,300
Other assets	21,400	24,400
Total Assets	12,169,000	11,967,500
Current Liabilities:
Senior secured convertible promissory notes, net	14,000,000	3,809,900
Accounts payable	2,136,000	7,308,100
Accrued expenses and other current liabilities	1,673,400	881,600
Interest payable	1,937,900	142,100
Note payable		557,200
Operating lease liability - short term	631,000	584,400
Total current liabilities	20,378,300	13,283,300
Subordinated convertible promissory note		2,914,000
Operating lease liability - long term	911,500	1,544,900
Total Liabilities	21,289,800	17,742,200
Stockholders' Deficit:
Preferred Stock, $0.0001 par value: 60,000,000 shares authorized, 14,000 and 0 issued and outstanding, with a liquidation preference of $16,205,500 and $0, as of December 31, 2023 and December 31, 2022, respectively	2
Common stock, $0.001 par value: 300,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 1,258,460 and 648,384 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively	1,258	648
Additional paid-in capital	113,774,740	96,172,152
Accumulated deficit	(122,896,800)	(101,947,500)
Total Stockholders' Deficit	(9,120,800)	(5,774,700)
Total Liabilities and Stockholders' Deficit	$ 12,169,000	$ 11,967,500

STOCK-BASED COMPENSATION

12 Months Ended

Dec. 31, 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	(273)		255.85	(433)		297.00
Cancelled and forfeited	(57)		260.10	(15,945)		382.50
Nonvested RSUs at December 31	320	$	285.36	650	$	259.50

Total stock compensation expense recognized from stock-based compensation awards classified as RSUs were recognized in the consolidated statements of operations for the years ended December 31, 2023 and 2022, as follows:


	December 31,
	2023		2022
Research and development	$	26,400	$	38,900
General and administrative		32,100		22,200
Total	$	58,500	$	61,100

As of December 31, 2023, there was $255,800 unrecognized stock compensation expense related to unvested restricted stock units.

2017 Stock Incentive Plan— Stock Options

The following table summarizes the activity for all stock options outstanding at December 31 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	(1,411)		277.50
Balance at December 31	5,853	$	285.36	11,286	$	254.40
Options exercisable at December 31:	5,853	$	285.36	11,218	$	256.20

In addition, the weighted average remaining contractual life for the options is 3.93 years and 4.93 years as of December 31, 2023 and December 31, 2022, respectively. The options have no intrinsic value as of December 31, 2023 or December 31, 2022.

Total stock compensation expense recognized from stock-based compensation awards classified as stock options were recognized in the consolidated statements of operations for the years ended December 31, 2023 and 2022, as follows:


	December 31,
	2023		2022
Research and development	$	—	$	65,000
General and administrative		—		30,000
Total	$	—	$	95,000

As of December 31, 2023, there was no unrecognized stock compensation expense related to unvested stock options.

As of December 31, 2022, total unrecognized stock compensation expense is $4,700, related to unvested stock options to be recognized over the remaining weighted-average vesting period of 0.29 years.

2021 Stock Incentive Plan—Restricted Stock Units

The following table summarizes the activity for all RSUs outstanding under the 2021 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	684	$	133.20	2,068	$	165.60
Granted	138,343		1.45	24,610		12.30
Vested	(83,700)		0.23	(25,241)		33.00
Cancelled and forfeited	(621)		126.60	(753)		206.40
Nonvested RSUs at December 31	54,706	$	1.56	684	$	133.20

Total stock compensation expense recognized from stock-based compensation awards classified as RSUs were recognized in the consolidated statements of operations for years ended December 31, 2023 and 2022, as follows:


	December 31,
	2023		2022
Research and development	$	37,700	$	56,300
General and administrative		44,900		302,200
Total	$	82,600	$	358,500

The vested outstanding restricted stock units that have not been released to grantees as of December 31, 2023, were included in calculation of weighted average common shares outstanding, basic and diluted (See Note 3, Net Loss Per Common Share). The Company plans to release these shares to the grantees in the near future. 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 December 31, 2023 under the 2022 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	(3,060)		—
Balance at December 31	12,240	$	12.90	21,420	$	12.90
Options exercisable at December 31:	12,240	$	12.90	21,420	$	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 3.93 years. There was no stock compensation expense during the year ended December 31, 2023 or December 31, 2022.

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2023

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Schedule of accrued expenses and other current liabilities


	December 31, 2023		December 31, 2022
Accrued litigation	$	447,500	$	—
Accrued compensation		864,900		668,700
Accrued consulting and outside services		361,000		212,900
Total	$	1,673,400	$	881,600

Condensed Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Cash flows from operating activities:
Net Income (Loss)	$ (20,949,300)	$ (34,731,000)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation	2,221,100	1,673,400
Operating lease non-cash expense	574,800	394,200
Stock compensation expense	141,300	1,237,100
Litigation settlement loss		3,313,400
Gain on sale of equipment		(12,800)
Amortization of debt issuance costs		9,900
Changes in operating assets and liabilities:
Accounts receivable		16,200
Prepaid expenses and other current assets	(179,300)	662,400
Accounts payable	(5,034,700)	3,790,800
Interest payable	1,795,800	142,100
Accrued litigation liability	447,500
Accrued expenses and other current liabilities	344,300	140,600
Operating lease liability	(586,800)	(382,200)
Net cash used for operating activities	(21,225,300)	(23,745,900)
Cash flows from investing activities:
Capital expenditures	(206,600)	(4,880,500)
Proceeds from sale of equipment		15,000
Net cash used for investing activities	(206,600)	(4,865,500)
Cash flows from financing activities:
Proceeds from senior secured convertible notes payable	24,000,000	4,000,000
Proceeds from issuance of common stock	659,100
Stock issuance costs	(111,200)
Borrowings from note payable		610,700
Repayments of note payable	(557,200)	(508,000)
Debt issuance costs		(200,000)
Net cash provided by financing activities	23,990,700	3,902,700
Net change in cash and cash equivalents	2,558,800	(24,708,700)
Cash and cash equivalents:
Beginning of year	645,200	25,353,900
End of year	3,204,000	645,200
Supplemental disclosures of cash flow information:
Cash paid for interest on note payable	56,400	12,200
Non-cash investing and financing activities:
Right-of-use asset/lease liability recognized from ASC842 implementation		2,232,700
Exchange of 25% senior convertible promissory notes into preferred stock	14,000,000
Conversion of subordinated convertible promissory notes into shares of common stock	2,914,000	399,400
Property and equipment in accounts payable	52,700	1,303,000
Right-of-use asset/liability acquired through lease liability		$ 303,662
Deferred financing costs forgiven	$ 364,700

Condensed Consolidated Statements of Operations - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Operating expenses:
Research and development	$ 9,624,900	$ 13,920,400
General and administrative	10,314,400	17,193,900
Total operating expenses	19,939,300	31,114,300
Loss from operations	(19,939,300)	(31,114,300)
Other expense:
Interest expense	(1,852,200)	(166,500)
Litigation settlement	(1,730,000)	(3,463,000)
Other income	2,572,200	12,800
Total other expense	(1,010,000)	(3,616,700)
Net loss	$ (20,949,300)	$ (34,731,000)
Net loss per preferred share, basic	$ (1,103.73)
Net loss per preferred share, diluted	(1,103.73)
Net loss per common share, basic	(12.59)	$ (64.42)
Net loss per common share, diluted	$ (12.59)	$ (64.42)
Weighted average preferred shares outstanding, basic	8,773
Weighted average preferred shares outstanding, diluted	8,773
Weighted average common shares outstanding, basic	1,097,630	544,475
Weighted average common shares outstanding, diluted	1,097,630	544,475

NET LOSS PER COMMON SHARE - Dilutive Securities Excluded From the Computations of Earnings Per Share (Details)	12 Months Ended
	Dec. 31, 2023 shares
Restricted Stock Units
Dilutive Securities Excluded From the Computations of Earnings Per Share
Potentially dilutive securities	59,632
Warrants
Dilutive Securities Excluded From the Computations of Earnings Per Share
Potentially dilutive securities	15,416

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

Use of Estimates

Concentrations of Credit Risk and Other Uncertainties

Property and Equipment


Asset Description		Estimated Lives
Laboratory Equipment		3 - 8
Leasehold Improvements		1 - 7
Office Furniture, Fixtures, and Equipment		5
Software		3 - 5

Internal Use Software Development Costs

Impairment of Long-Lived Assets

Comprehensive Loss

Income Taxes

Research and Development Expense

Fair Value Measurements

Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

Level 3—Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.

There were no changes in the fair value hierarchy leveling during the years ended December 31, 2023 or 2022.

Nonvested Stock Options and Restricted Stock Units

of share-based payments and incentives to board members, employees, and non-employees through grants of nonvested stock options and restricted stock units (“RSUs”).

Stock-Based Compensation

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:

Warrants Underlying Shares from common stock offerings

Expected Term. The expected term represents the period that warrants are expected to be outstanding. The expected term was calculated by taking the average of the vesting period and contract period.

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

NET LOSS PER COMMON SHARE

12 Months Ended

Dec. 31, 2023

NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE

3.	NET LOSS PER COMMON SHARE

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:


	Year Ended
	December 31,
	2023		2022
Net loss	$	(20,949,300)	$	(34,731,000)
Less: Initial Public Offering Common Stock discount amortization		(99,900)		(100,000)
Less: Public Offering Common Stock discount amortization		(244,800)		(244,800)
Less: Undeclared dividends attributable to preferred stock		(2,205,500)		—
Net loss attributable to common shareholders	$	(23,499,500)	$	(35,075,800)


	Year Ended				Year Ended
	December 31, 2023				December 31, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(13,816,900)	$	(9,682,600)	$	(35,075,800)	$	—
Weighted average shares outstanding, basic and diluted		1,097,630		8,773		544,475		—
Basic and diluted net loss per share	$	(12.59)	$	(1,103.73)	$	(64.42)	$	—

For the year ended December 31, 2023, there were 59,632 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 year ended December 31, 2023, the Company entered into an Exchange Agreement whereby outstanding promissory notes totaling $14,000,000 were exchanged for 14,000 shares of Series C Convertible Voting Preferred Stock (the “Series C Stock”). See Note 10 for details about conversion price. 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 year ended December 31, 2023, the preferred shareholders earned $2,205,500 of preferred dividends. The dividends were not accrued on the condensed consolidated balance sheet as of December 31, 2023, as these dividends were not declared.

INCOME TAXES

12 Months Ended

Dec. 31, 2023

INCOME TAXES

INCOME TAXES

12.	INCOME TAXES

For the years ended December 31, 2023 and 2022, the Company recognized no provision or benefit from income taxes.

The following is a reconciliation of the effective income tax rate to the statutory federal income tax rate for the years ended December 31, 2023 and 2022.


	2023		2022
Federal income tax at statutory rates	21.00	%	21.00	%
Federal income tax rate reduction	—	%	—	%
Change in valuation allowance	(21.00)		(21.00)
Effective income tax rate	—	%	—	%

Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences. The Company recorded a valuation allowance to fully offset the net deferred tax asset, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets as of December 31, 2023 or 2022 due to the significant uncertainty about the realization of the deferred tax asset until the Company can operate profitably.

The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets are as follows as of December 31:


	2023		2022
Deferred tax assets (liabilities):
Net operating loss carryforward	$	16,178,000	$	12,668,900
Stock compensation expense		470,700		3,371,900
Research and development tax credit		2,156,300		874,400
Sec. 174 Research and experimentation expense		3,206,600		2,293,000
Property and equipment		260,200		105,800
Intangible assets		81,600		88,500
Lease liability		323,900		428,400
Accrued expenses		139,700		158,500
Total gross deferred tax assets		22,817,000		19,989,400
Valuation allowance		(22,493,100)		(19,563,500)
Right-of-use assets		(323,900)		(425,900)
Net deferred tax assets (liabilities)		—		—

As of December 31, 2023 and 2022, the Company has U.S. net operating loss ("NOL") carryforwards of $77,037,900 and $60,328,200, respectively. NOL carryforwards of $6,126,173 are subject to expiration beginning in 2036. The remaining approximately $70,911,727 of NOL carryforwards may be carried forward indefinitely until it is fully utilized.

The NOL carryforwards may be subject to annual limitations due to "change in ownership" provisions of Internal Revenue Code Section 382 ("Section 382") that can be triggered due to future ownership changes. Additionally, the NOL loss carryforwards are subject to examination and adjustments by the Internal Revenue Service until the statute of limitations closes on the year in which the NOL is utilized.

As of December 31, 2023 and 2022, there were no material uncertain tax positions taken by the Company. Additionally, the Company does not expect any unrecognized tax benefits to change significantly over the next twelve months.

As of December 31, 2023, the Company is not currently under audit by any income tax authority.

- 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
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-21

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

PROPERTY AND EQUIPMENT, NET (Tables)

12 Months Ended

Dec. 31, 2023

PROPERTY AND EQUIPMENT, NET

Schedule of property and equipment


	December 31, 2023		December 31, 2022
Equipment	$	3,126,300	$	3,041,900
Leasehold improvements		7,372,100		7,298,500
Office furniture, fixtures, and equipment		137,300		137,300
Software		359,500		359,500
Construction in progress		101,300		—
		11,096,500		10,837,200
Less: Accumulated depreciation		(4,921,400)		(2,700,300)
Total	$	6,175,100	$	8,136,900

LEASES - Operating lease liability maturities (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Operating leases
2024	$ 717,600
2025	724,700
2026	242,800
Total lease payments	1,685,100
Less: imputed interest	(142,600)
Present value of lease payments	$ 1,542,500	$ 2,129,300

LEASES

12 Months Ended

Dec. 31, 2023

Leases

LEASES

9.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 December 31, 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.

Another amendment to the lease agreement was executed in May 2022 and commenced August 2, 2022. The amendment added approximately 1,458 square feet. The Company has the option to cancel the lease thereafter until the agreement expires on April 30, 2026. In year one, the monthly rent is $2,430 per month, in years two and three monthly rent is $2,490 per month, and in year five monthly rent is $2,552 per month.

There are no variable payments associated with the lease agreements, as the rent payments are predetermined on a fixed schedule and disclosed above.

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



	December 31, 2023			December 31, 2022
	Operating lease			Operating lease
Right-of-Use Asset
Operating lease	$	1,542,500	$	2,117,300
Total right-of use asset	$	1,542,500	$	2,117,300

Lease Liabilities
Operating lease - short term	$	(631,000)	$	(584,400)
Operating lease - long term		(911,500)		(1,544,900)
Total lease liabilities	$	(1,542,500)	$	(2,129,300)

For the year ended December 31, 2023 and December 31, 2022, the components of lease expense were as follows:


	Years Ended
		December 31, 2023			December 31, 2022
Operating lease cost allocated to research and development expense	$	393,900		$	473,200
Operating lease cost allocated to general and administrative expense		322,200			189,900
Total lease expense	$	716,100		$	663,100
Weighted-average remaining lease term		2.34			3.34
Weighted-average discount rate		7.12	%		7.12	%

As of December 31, 2023, the maturities of the Company’s operating lease liabilities were as follows:


Maturity of Lease Liabilities		Operating lease
2024	$	717,600
2025		724,700
2026		242,800
Total lease payments		1,685,100
Less: imputed interest		(142,600)
Present value of lease payments	$	1,542,500

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 year ended December 31, 2022, short-term lease expense was $22,500.

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.

SUBSEQUENT EVENTS (Details)							12 Months Ended	24 Months Ended
SUBSEQUENT EVENTS (Details)	Mar. 07, 2024 USD ($)	Feb. 12, 2024 USD ($)	Jan. 08, 2024 USD ($)	Jul. 18, 2023 item shares	Apr. 02, 2023 item shares	Apr. 03, 2020	Dec. 31, 2023 USD ($) shares	Dec. 31, 2023 USD ($) shares	Dec. 31, 2022 shares
Subsequent events
Principal amount \| $							$ 24,000,000	$ 24,000,000
Preferred stock, issued							14,000	14,000	0
Molipharma Joint Venture
Subsequent events
Term of joint venture agreement						5 years
Term of available extension of the joint venture agreement						5 years
Non-renewal notice prior to expiration date required to cancel the joint venture agreement						1 year
Series C Preferred Stock
Subsequent events
Preferred stock, issued				6,000	8,000		14,000	14,000
25% Senior Secured Convertible Promissory Notes
Subsequent events
Interest rate (as a percent)				25.00%	25.00%		25.00%	25.00%
Note term								1 year
Number of promissory notes exchanged \| item				3	4
Interest rate increase to per annum							27.00%
25% Senior Secured Convertible Promissory Notes \| Series C Preferred Stock
Subsequent events
Preferred stock, issued				6,000	8,000
Subsequent Event \| 25% Senior Secured Convertible Promissory Notes
Subsequent events
Principal amount \| $	$ 2,000,000	$ 2,000,000	$ 2,000,000
Interest rate (as a percent)	25.00%	25.00%	25.00%
Note term	365 days	365 days	365 days
Interest rate increase to per annum	27.00%	27.00%	27.00%

NET LOSS PER COMMON SHARE - Series C Stock (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Jul. 31, 2023	Jul. 18, 2023	Apr. 30, 2023	Apr. 02, 2023	Dec. 31, 2022
Debt conversion
Preferred stock, issued	14,000					0
Undeclared preferred dividends	$ 2,205,500
25% Senior Secured Convertible Promissory Notes
Debt conversion
Aggregate principal amount of convertible debt exchanged	$ 14,000,000	$ 6,000,000	$ 6,000,000	$ 8,000,000	$ 8,000,000
Series C Preferred Stock
Debt conversion
Annual dividend rate	25.00%
Preferred stock, issued	14,000		6,000		8,000
Preferred dividends	$ 2,205,500
Series C Preferred Stock \| 25% Senior Secured Convertible Promissory Notes
Debt conversion
Preferred stock, issued			6,000		8,000

INCOME TAXES - Deferred Tax Assets and Liabilities (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Deferred tax assets (liabilities):
Net operating loss carryforward	$ 16,178,000	$ 12,668,900
Stock compensation expense	470,700	3,371,900
Research and development tax credit	2,156,300	874,400
Sec. 174 Research and experimentation expense	3,206,600	2,293,000
Property and equipment	260,200	105,800
Intangible assets	81,600	88,500
Lease liability	323,900	428,400
Accrued expenses	139,700	158,500
Total gross deferred tax assets	22,817,000	19,989,400
Valuation allowance	(22,493,100)	(19,563,500)
Right-of-use assets	$ (323,900)	$ (425,900)

NET LOSS PER COMMON SHARE (Tables)

12 Months Ended

Dec. 31, 2023

NET LOSS PER COMMON SHARE

Schedule of earnings per share, basic and diluted


	Year Ended
	December 31,
	2023		2022
Net loss	$	(20,949,300)	$	(34,731,000)
Less: Initial Public Offering Common Stock discount amortization		(99,900)		(100,000)
Less: Public Offering Common Stock discount amortization		(244,800)		(244,800)
Less: Undeclared dividends attributable to preferred stock		(2,205,500)		—
Net loss attributable to common shareholders	$	(23,499,500)	$	(35,075,800)


	Year Ended				Year Ended
	December 31, 2023				December 31, 2022
	Common Stock		Preferred Stock		Common Stock		Preferred Stock
Net loss per share, basic and diluted
Allocation of undistributed net loss	$	(13,816,900)	$	(9,682,600)	$	(35,075,800)	$	—
Weighted average shares outstanding, basic and diluted		1,097,630		8,773		544,475		—
Basic and diluted net loss per share	$	(12.59)	$	(1,103.73)	$	(64.42)	$	—

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)	Dec. 31, 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	14,000	0
Preferred stock, outstanding	14,000	0
Liquidation preference, value	$ 16,205,500	$ 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	1,258,460	648,384
Common stock, outstanding	1,258,460	648,384

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2023	Mar. 18, 2024	Jun. 30, 2023
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Transition Report	false
Document Period End Date	Dec. 31, 2023
Entity File Number	001-39169
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 Shares, par value $0.001 per share
Trading Symbol	KRBP
Security Exchange Name	NONE
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction	false
Entity Shell Company	false
Entity Public Float			$ 3,175,902
Entity Common Stock, Shares Outstanding		1,288,235
Auditor Name	Whitley Penn
Auditor Firm ID	726
Auditor Location	Houston, Texas
Entity Central Index Key	0001792581
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	FY
Amendment Flag	false

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued litigation	$ 447,500
Accrued compensation	864,900	$ 668,700
Accrued consulting and outside services	361,000	212,900
Total	$ 1,673,400	$ 881,600

NOTE PAYABLE

12 Months Ended

Dec. 31, 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 December 31, 2022, this remaining payable balance on the financed amount was $557,200. As of December 31, 2023, this financing arrangement was paid in its entirety.

STOCK-BASED COMPENSATION - Stock Options (Details) - Employee Stock Option - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Stock Incentive Plan 2017
Stock option activity
Options outstanding at beginning of period	11,286	12,697
Cancelled and forfeited	(5,433)	(1,411)
Balance at December 31:	5,853	11,286
Options exercisable at December 31	5,853	11,218
Intrinsic value of options exercisable	$ 0	$ 0
Weighted average exercise price
Options outstanding at beginning of period	$ 254.40	$ 257.10
Cancelled and forfeited	215.35	277.50
Balance at December 31	285.36	254.40
Options exercisable at December 31	$ 285.36	$ 256.20
Additional stock option information
Stock compensation expense		$ 95,000
Total unrecognized stock compensation expense	$ 0	$ 4,700
Weighted-average period over which cost not yet recognized is expected to be recognized		3 months 14 days
Weighted-average remaining contractual life	3 years 11 months 4 days	4 years 11 months 4 days
Stock Incentive Plan 2017 \| Research and development
Additional stock option information
Stock compensation expense		$ 65,000
Stock Incentive Plan 2017 \| General and administrative
Additional stock option information
Stock compensation expense		$ 30,000
Stock Incentive Plan 2021
Stock option activity
Options outstanding at beginning of period	21,420
Granted		24,480
Cancelled and forfeited	(9,180)	(3,060)
Balance at December 31:	12,240	21,420
Options exercisable at December 31	12,240	21,420
Weighted average exercise price
Options outstanding at beginning of period	$ 12.90
Granted		$ 12.90
Cancelled and forfeited	12.90
Balance at December 31	12.90	12.90
Options exercisable at December 31	$ 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
Options outstanding, weighted average remaining contractual life	3 years 11 months 4 days

STOCK-BASED COMPENSATION (Tables)

12 Months Ended

Dec. 31, 2023

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	(273)		255.85	(433)		297.00
Cancelled and forfeited	(57)		260.10	(15,945)		382.50
Nonvested RSUs at December 31	320	$	285.36	650	$	259.50

Schedule of stock-based compensation


	December 31,
	2023		2022
Research and development	$	26,400	$	38,900
General and administrative		32,100		22,200
Total	$	58,500	$	61,100

Stock Incentive Plan 2017 | Employee Stock Option

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	(1,411)		277.50
Balance at December 31	5,853	$	285.36	11,286	$	254.40
Options exercisable at December 31:	5,853	$	285.36	11,218	$	256.20

Schedule of stock-based compensation


	December 31,
	2023		2022
Research and development	$	—	$	65,000
General and administrative		—		30,000
Total	$	—	$	95,000

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	138,343		1.45	24,610		12.30
Vested	(83,700)		0.23	(25,241)		33.00
Cancelled and forfeited	(621)		126.60	(753)		206.40
Nonvested RSUs at December 31	54,706	$	1.56	684	$	133.20

Schedule of stock-based compensation


	December 31,
	2023		2022
Research and development	$	37,700	$	56,300
General and administrative		44,900		302,200
Total	$	82,600	$	358,500

Stock Incentive Plan 2021 | Employee Stock Option

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	(3,060)		—
Balance at December 31	12,240	$	12.90	21,420	$	12.90
Options exercisable at December 31:	12,240	$	12.90	21,420	$	12.90
Weighted average grant date fair value for options granted during the year:		$	—		$	10.80

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)(iv)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480429/718-10-50-2

Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)(v)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480429/718-10-50-2

+ Details

Condensed Consolidated Statements of Cash Flows (Parenthetical)	Dec. 31, 2023	Jul. 18, 2023	Apr. 02, 2023
25% Senior Secured Convertible Promissory Notes
Interest rate (as a percent)	25.00%	25.00%	25.00%

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

12 Months Ended

Dec. 31, 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 at:


	December 31, 2023		December 31, 2022
Accrued litigation	$	447,500	$	—
Accrued compensation		864,900		668,700
Accrued consulting and outside services		361,000		212,900
Total	$	1,673,400	$	881,600

LEASES (Tables)

12 Months Ended

Dec. 31, 2023

Leases

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



	December 31, 2023			December 31, 2022
	Operating lease			Operating lease
Right-of-Use Asset
Operating lease	$	1,542,500	$	2,117,300
Total right-of use asset	$	1,542,500	$	2,117,300

Lease Liabilities
Operating lease - short term	$	(631,000)	$	(584,400)
Operating lease - long term		(911,500)		(1,544,900)
Total lease liabilities	$	(1,542,500)	$	(2,129,300)

Schedule of components of lease expense


	Years Ended
		December 31, 2023			December 31, 2022
Operating lease cost allocated to research and development expense	$	393,900		$	473,200
Operating lease cost allocated to general and administrative expense		322,200			189,900
Total lease expense	$	716,100		$	663,100
Weighted-average remaining lease term		2.34			3.34
Weighted-average discount rate		7.12	%		7.12	%

Schedule of maturities of operating lease liabilities


Maturity of Lease Liabilities		Operating lease
2024	$	717,600
2025		724,700
2026		242,800
Total lease payments		1,685,100
Less: imputed interest		(142,600)
Present value of lease payments	$	1,542,500

LEASES - Short-term Lease (Details)	12 Months Ended
LEASES - Short-term Lease (Details)	Dec. 31, 2022 USD ($)
Leases
Monthly rent expense on short-term lease	$ 2,500
Short-term lease expense	$ 22,500

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2023

INCOME TAXES

Schedule of reconciliation of the effective income tax rate to the statutory federal income tax rate


	2023		2022
Federal income tax at statutory rates	21.00	%	21.00	%
Federal income tax rate reduction	—	%	—	%
Change in valuation allowance	(21.00)		(21.00)
Effective income tax rate	—	%	—	%

Schedule of tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets


	2023		2022
Deferred tax assets (liabilities):
Net operating loss carryforward	$	16,178,000	$	12,668,900
Stock compensation expense		470,700		3,371,900
Research and development tax credit		2,156,300		874,400
Sec. 174 Research and experimentation expense		3,206,600		2,293,000
Property and equipment		260,200		105,800
Intangible assets		81,600		88,500
Lease liability		323,900		428,400
Accrued expenses		139,700		158,500
Total gross deferred tax assets		22,817,000		19,989,400
Valuation allowance		(22,493,100)		(19,563,500)
Right-of-use assets		(323,900)		(425,900)
Net deferred tax assets (liabilities)		—		—

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2023

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

13.SUBSEQUENT EVENTS

Issuance of Senior Secured Convertible Promissory Note

On January 8, 2024, February 12, 2024 and March 7, 2024, the Company issued a 25% Senior Secured Convertible Promissory Note to an investor (each a “Subsequent Note” and together the “Subsequent Notes”). Each Subsequent Note has a principal amount of $2,000,000, bears interest at a rate of 25% per annum and matures 365 days from the date of issuance, on which the principal balance and accrued but unpaid interest under each Subsequent Note is due and payable. The interest rate for each Subsequent Note 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.

Molipharma Agreement

On April 3, 2020, we entered into a joint venture agreement ("Joint Venture") with Molipharma, S.R.L. ("Molipharma") to collaborate in (1) a clinical trial program in oncology development ("Oncology") and (2) a clinical trial program in COVID-19 Vaccine ("COVID-19 Vaccine").

With respect to Oncology, we will grant a low single digit royalty to Molipharma for turnover of the marketing of ovarian cancer research in Europe. With respect to COVID-19 Vaccine, economic rights in Europe will transfer to Molipharma, and economic rights in the U.S. will transfer to us. Molipharma agreed to financially support the research program for COVID-19 and we agreed to financially support the research program in oncology. The Joint Venture has a duration of five years, extendable for a further five years, unless notice of non-renewal is sent one year before the expiration date. The parties may withdraw from the Joint Venture only for serious and justified reasons or by mutual consent.

On February 28, 2024, we notified Molipharma of the Company’s intent not to renew, allowing the Joint Venture to expire on April 2, 2025.

STOCKHOLDERS DEFICIT - Stock (Details)	12 Months Ended
STOCKHOLDERS DEFICIT - Stock (Details)	Dec. 31, 2023 USD ($) Vote $ / shares shares	Jul. 31, 2023 agreement	Jul. 18, 2023 shares	Apr. 02, 2023 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	1,258,460				648,384
Common stock, outstanding	1,258,460				648,384
Preferred stock, issued	14,000				0
Number of exchange agreements entered into \| agreement		2
Preferred stock, outstanding	14,000				0
Common stock, par value (in dollars per share) \| $ / shares	$ 0.001				$ 0.001
Liquidation preference, value \| $	$ 16,205,500				$ 0
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, issued	14,000		6,000	8,000
Preferred stock, outstanding	14,000
Annual dividend rate	25.00%
Liquidation preference, value \| $	$ 16,205,500				$ 0
Common Stock
Common stock
Number of entitled votes per share \| Vote	1

STOCKHOLDERS DEFICIT - Representative's Warrants (Details) - Common Stock Warrants - Representative - $ / shares	Jul. 02, 2021	Oct. 15, 2020	Dec. 31, 2023
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	$ 15.00
Exercise price as a percentage of the initial offering price		125.00%
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		$ 6.25
Exercise price as a percentage of the initial offering price	125.00%

ORGANIZATION (Details)		12 Months Ended
ORGANIZATION (Details)	Mar. 10, 2023	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
ORGANIZATION
Stock split (Reverse stock split) ratio	30
Decrease in accounts payable resulting from renegotiation of service agreement		$ 1,100,000
Decrease in deferred financing costs resulting from renegotiation of service agreement		360,000
Oher income resulting from renegotiation of service agreement		740,000
Cash flow from operations		(21,225,300)	$ (23,745,900)
Accumulated deficit		$ (122,896,800)	$ (101,947,500)

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE - Maturity (Details) - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Debt Instrument
Total Convertible Promissory Note	$ 14,000,000	$ 4,000,000
Less: unamortized debt issuance costs		(190,100)
Convertible Promissory Note, net	14,000,000	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 June 26, 2024
Debt Instrument
Total Convertible Promissory Note	2,400,000
Senior Secured Convertible Promissory Note, maturing July 25, 2024
Debt Instrument
Total Convertible Promissory Note	2,400,000
Senior Secured Convertible Promissory Note, maturing August 25, 2024
Debt Instrument
Total Convertible Promissory Note	2,400,000
Senior Secured Convertible Promissory Note, maturing September 27, 2024
Debt Instrument
Total Convertible Promissory Note	2,400,000
Senior Secured Convertible Promissory Note Maturing November 2, 2024
Debt Instrument
Total Convertible Promissory Note	2,400,000
Senior Secured Convertible Promissory Note Maturing December 12, 2024
Debt Instrument
Total Convertible Promissory Note	$ 2,000,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Property and Equipment
Impairment of long-lived assets held-for-use	$ 0	$ 0
Unrecognized tax benefits, interest or penalties	$ 0	0
Minimum
Property and Equipment
Property plant and equipment useful life	1 year
Maximum
Property and Equipment
Property plant and equipment useful life	8 years
Laboratory equipment \| Minimum
Property and Equipment
Property plant and equipment useful life	3 years
Laboratory equipment \| Maximum
Property and Equipment
Property plant and equipment useful life	8 years
Leasehold improvements \| Minimum
Property and Equipment
Property plant and equipment useful life	1 year
Leasehold improvements \| Maximum
Property and Equipment
Property plant and equipment useful life	7 years
Office furniture, fixtures, and equipment
Property and Equipment
Property plant and equipment useful life	5 years
Software \| Minimum
Property and Equipment
Property plant and equipment useful life	3 years
Software \| Maximum
Property and Equipment
Property plant and equipment useful life	5 years
Software development costs
Property and Equipment
Property plant and equipment useful life	5 years
Capitalized software development costs	$ 91,500	$ 107,000

STOCKHOLDERS DEFICIT - Exchange Agreement (Details)	Jul. 18, 2023 USD ($) item shares	Apr. 02, 2023 USD ($) item shares	Dec. 31, 2023 USD ($) shares	Jul. 31, 2023 USD ($)	Apr. 30, 2023 USD ($)	Dec. 31, 2022 shares
Note Purchase Agreement
Preferred stock, issued			14,000			0
Series C Preferred Stock
Note Purchase Agreement
Preferred stock, issued	6,000	8,000	14,000
25% Senior Secured Convertible Promissory Notes
Note Purchase Agreement
Aggregate principal amount of convertible debt exchanged \| $	$ 6,000,000	$ 8,000,000	$ 14,000,000	$ 6,000,000	$ 8,000,000
Interest rate (as a percent)	25.00%	25.00%	25.00%
Number of promissory notes exchanged \| item	3	4
Principal amount of the individual debt instruments exchanged. \| $	$ 2,000,000	$ 2,000,000
25% Senior Secured Convertible Promissory Notes \| Series C Preferred Stock
Note Purchase Agreement
Preferred stock, issued	6,000	8,000

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482900/835-30-50-1

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(f))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-3

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (a)
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
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-Name Accounting Standards Codification
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Reference 7: http://www.xbrl.org/2003/role/exampleRef
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Reference 8: http://www.xbrl.org/2003/role/exampleRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Name Accounting Standards Codification
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-Paragraph 1B
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

SENIOR SECURED CONVERTIBLE PROMISSORY NOTE (Details)	12 Months Ended		24 Months Ended
SENIOR SECURED CONVERTIBLE PROMISSORY NOTE (Details)	Dec. 31, 2023 USD ($) item $ / shares	Dec. 31, 2022 USD ($)	Dec. 31, 2023 USD ($) item $ / shares	Jul. 31, 2023 USD ($)	Jul. 18, 2023 USD ($)	Apr. 30, 2023 USD ($)	Apr. 02, 2023 USD ($)
Debt Instrument
Number of promissory notes issued \| item			13
Aggregate principal of debt instruments issued			$ 28,000,000
Principal amount	$ 24,000,000		$ 24,000,000
Proceeds from senior secured convertible notes payable	$ 24,000,000	$ 4,000,000
Number of promissory notes outstanding \| item	6
25% Senior Secured Convertible Promissory Notes
Debt Instrument
Interest rate (as a percent)	25.00%		25.00%		25.00%		25.00%
Note term			1 year
Interest rate increase to per annum	27.00%
Aggregate principal amount of convertible debt exchanged	$ 14,000,000		$ 14,000,000	$ 6,000,000	$ 6,000,000	$ 8,000,000	$ 8,000,000
25% Senior secured convertible promissory note with $6.50 conversion price
Debt Instrument
Principal amount	$ 2,400,000		$ 2,400,000
Number of promissory notes outstanding \| item	2
Conversion price \| $ / shares	$ 6.50		$ 6.50
25% Senior secured convertible promissory note with $5.00 conversion price
Debt Instrument
Principal amount	$ 2,400,000		$ 2,400,000
Number of promissory notes outstanding \| item	2
Conversion price \| $ / shares	$ 5.00		$ 5.00
Senior Secured Convertible Promissory Notes, 25 Percent, 2.50 Conversion Price, Note 1
Debt Instrument
Principal amount	$ 2,400,000		$ 2,400,000
Number of promissory notes outstanding \| item	1
Conversion price \| $ / shares	$ 2.50		$ 2.50
Senior Secured Convertible Promissory Notes, 25 Percent, 2.50 Conversion Price, Note 2
Debt Instrument
Principal amount	$ 2,000,000		$ 2,000,000
Number of promissory notes outstanding \| item	1
Conversion price \| $ / shares	$ 2.50		$ 2.50