Curative Biotechnology Inc S-1/A, filed Jan 9, 2023

Curative Biotechnology Inc (CUBT)

S-1/A 2023-01-09

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		Emerging growth company	☒

	Per Unit	Total
Public offering price	$	$
Underwriting discounts (1)	$	$
Underwriter’s Warrants (2)	$	$
Proceeds to us before offering expenses (3)	$	$

(1)	In addition to the underwriting discounts and commissions, we have agreed to reimburse the underwriter for certain expenses, including a non-accountable expense allowance equal to 1.0% of the gross proceeds we receive in this offering. See “Underwriting” on page 74 of this prospectus for a description of these arrangements.
(2)	The Underwriter’s Warrants will represent the right to purchase 5.0% of the aggregate number of shares of common stock sold in this offering, excluding the overallotment option, at an exercise price equal to 125% of the offering price per share
(3)	We estimate the total expenses of this offering will be approximately $960,000. Upon closing, we have also agreed to reimburse $100,000 of the underwriter’s expenses relating to the offering, including for road show, diligence, and legal expenses.

	Page
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	ii
PROSPECTUS SUMMARY	1
RISK FACTORS	7
USE OF PROCEEDS	29
CAPITALIZATION	30
DILUTION	31
DETERMINATION OF OFFERING PRICE	31
DIVIDEND POLICY	32
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	32
BUSINESS	37
DESCRIPTION OF SECURITIES	56
MANAGEMENT	63
EXECUTIVE COMPENSATION	67
PRINCIPAL STOCKHOLDERS	70
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS	72
UNDERWRITING	74
LEGAL MATTERS	77
EXPERTS	77
WHERE YOU CAN FIND MORE INFORMATION	77
INDEX TO FINANCIAL STATEMENTS	F-1

	●	statements relating to projected growth and management’s long-term performance goals;
	●	statements relating to the anticipated effects on results of operations or our financial condition from expected developments or events;
	●	statements relating to our business and growth strategies; and
	●	any other statements which are not historical facts.

	●	our current and anticipated cash needs and our need for additional financing;
	●	federal, state and foreign regulatory requirements;
	●	our future ability to conduct clinical trials with respect to our products and services;
	●	our ability to develop and commercialize our products and services;
	●	our ability to enter into agreements to implement our business strategy;
	●	the acceptance of our products and services by patients and the medical community;
	●	our manufacturing capabilities to produce our products;
	●	our ability to maintain exclusive rights with respect to our licensed technology;
	●	our ability to protect our intellectual property;
	●	our ability to obtain and maintain an adequate level of insurance;
	●	our ability to obtain third party reimbursement for our products and services from private and governmental insurers;
	●	the effects of competition in our market areas;
	●	our reliance on certain key personnel;
	●	further sales or other dilution of our equity, which may adversely affect the market price of our Common Stock; and
	●	other factors and risks described under “Risk Factors” beginning on page 7 of this prospectus.

	(1)	Each of these therapeutics have undergone certain toxicology and pharmacokinetics animal studies. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.
	(2)	Each of these therapeutics have not undergone pre-clinical development. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.

	●	We have a limited operating history and may be unable to predict future operations;

	●	Our independent auditor’s report for the years ended December 31, 2021, and 2020, contains a qualification as to our ability to continue as a going concern, and management, in consultation with our independent auditor has also determined there is a going concern as of September 30, 2022;

	●	We are an early-stage company, have no product revenues, are not profitable and may never be profitable;

	●	We will need to obtain a significant amount of financing to initiate and complete our clinical trials and implement our business plan;

	●	We have incurred significant losses in prior periods, and losses in the future could have a material adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows;

	●	We expect to rely on third parties to conduct our clinical trials and all or most aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing;

	●	We may rely entirely on third parties for the manufacturing of our product candidates or other product candidates that we may develop for preclinical studies and clinical trials and expect to continue to do so for commercialization. Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices;

	●	If we fail to comply with the obligations of our licensing agreements or these agreements are terminated or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business;

	●	If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.

	●	The insurance coverage and reimbursement status of newly-approved products is uncertain. Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.

	●	We have paid no dividends and we do not anticipate paying any cash dividends in the foreseeable future.

	●	Investors in this offering will experience immediate and substantial dilution in net tangible book value.

	●	If, following this offering, our Common Stock becomes classified again as a “penny stock,” the restrictions of the penny stock regulations of the Securities and Exchange Commission, or SEC, may result in less liquidity for our Common Stock.

	●	A reverse stock split could cause our stock price to decline relative to its value before the split.

	●	Even if the reverse stock split achieves the requisite increase in the market price of our Common Stock, we cannot assure you that we will be able to continue to comply with the minimum trading price requirement of NYSE American.

	●	Following the reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.

	●	Assuming the conversion of our Series C Preferred Stock, the holders of our Series B Preferred Stock will still have certain rights, preferences, and privileges over our shares of Common Stock, including the right to approve certain transactions.

	●	In order to have our securities continue to be listed on the NYSE American, among other requirements, we will need to add independent qualified persons to our Board.

	●	In connection with the reverse stock split, we will have additional authorized shares of Common Stock available for issuance; the issuance of such additional shares would dilute the percentage ownership of existing stockholders.

	●	The Common Stock purchase warrant issued in our March 2022 secured note offering may be adjusted in the number of shares underlying the warrant upon completion of this offering, which would result in further dilution to our shareholders.

	●	As of January 4, 2023, our management team and Board of Directors have unilateral control over key decision making as a result of their control of a majority of our voting stock.

	●	Our amended and restated Bylaws provide that the state of Florida is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Securities Offered:		1,333,333 Units, each consisting of one share of Common Stock and one Warrant to purchase one share of Common Stock. The Units will not be certificated or issued in stand-alone form. The shares of our Common Stock and the Warrants comprising the Units are immediately separable upon issuance and will be issued separately; but will be purchased together in this offering.

Description of Warrants included in Units:		The exercise price of the Warrants is $9.00 per share (150% of the public offering price per Unit). Each Warrant is exercisable for one share of Common Stock. Each Warrant will be exercisable immediately upon issuance and will expire five years after the initial issuance date. The terms of the Warrants will be governed by a warrant agency agreement, dated as of the effective date of this offering, between us and Issuer Direct Corporation as the warrant agent (the “Warrant Agent”). The Warrants will be subject to redemption at a redemption price of $0.01 per Warrant commencing six months from issuance subject to the condition that the volume weighted average price of the Company’s common stock exceeds 200% of the initial exercise price for twenty (20) consecutive trading days and subject to certain other conditions set forth in the Warrants. This prospectus also relates to the offering of the shares of Common Stock issuable upon exercise of the Warrants. For more information regarding the warrants, you should carefully read the section titled “Description of Our Securities—Warrants” in this prospectus.

Common Stock Outstanding prior to the Offering:		1,448,177 shares based on the reverse stock split ratio of 1-for-400 (which amount does not include the conversion of Series C Preferred Stock).

Common Stock Outstanding Immediately after the Offering:		3,402,157 shares, including the conversion of Series C Preferred Stock into 620,647 shares of Common Stock (or 3,602,156 shares, if the underwriter exercises its over-allotment option in full), based on a public offering price of $6.00 per share.

Underwriter’s Over-Allotment Option:		The underwriting agreement provides that we will grant to the underwriter, an option, exercisable within 45 days after the date of this prospectus, to acquire up to an additional 15% of the total number of shares of Common Stock and Warrants sold by us pursuant to this offering, solely for the purpose of covering over-allotments, if any.

Use of Proceeds:		We estimate that we will receive net proceeds of approximately $6.8 million from our sale of Units in this offering assuming the sale of all Units at $6.00 per share (based on the reverse split ratio as described on the cover page of this prospectus), after deducting underwriting discounts and estimated offering expenses payable by us. We intend to use the net proceeds of this offering, including any over-allotment amount, as follows: (i) for the repayment of amounts due under our March 2022 secured convertible promissory note and May 2022 unsecured promissory note, and (ii) for our programs, we will complete necessary preclinical trials, IND-enabling studies, manufacturing, and other necessary costs related to submitting IND applications for our product candidates. In the event we receive approval of one or more of our proposed INDs, we intend to proceed with up to two (2) clinical trials (Rabies and Dry-Age Macular Degeneration). The remainder of funds will be used for general corporate and business purposes; however, the use of the net proceeds is subject to change at the complete and absolute discretion of our management. For a more complete description of our anticipated use of proceeds from this offering, see “Use of Proceeds.”

Proposed Trading Symbol:		Our shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American under the symbol “CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”. The listing of the Common Stock and the Warrants is a condition to this offering. If our Warrant listing application is not approved, we will not complete this offering.

Series C Preferred Stock Conversion and anti-dilution rights:		Immediately prior to the closing of the offering, the holders of the issued and outstanding shares of Series C Preferred Stock have agreed to convert their shares of Series C Preferred Stock into shares of Common Stock. The Series C Preferred Stock will collectively convert into thirty percent (30%) of the total issued and outstanding shares of Common Stock on a post conversion basis immediately prior to the closing of the offering, or approximately 620,647 shares of Common Stock, without the payment of any additional consideration by the holders, based on the reverse stock split ratio as described on the cover page of this prospectus.

Risk Factors:		Investing in our securities involves substantial risks. You should carefully review and consider the “Risk Factors” section of this prospectus beginning on page 7 and the other information in this prospectus for a discussion of the factors you should consider before you decide to invest in this offering.

	●	176,246 shares of Common Stock issuable upon the exercise of outstanding warrants having an average weighted exercise price of $31.86. Notwithstanding, such amount of warrants will increase by 262,432 shares of Common Stock (assuming the $6.00 offering price and utilizing the 1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender in our March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon the consummation of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less than $20.00;

	●	18,641 shares of Common Stock issuable upon the exercise of outstanding equity awards pursuant to our 2021 Equity Incentive Plan; and

	●	the exercise of the Warrants contained in the Units; and

	●	the exercise by the underwriter of its option to purchase additional Units.

	●	the inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that the applicable product candidate is safe and effective as a treatment for our targeted indications;

	●	the FDA or comparable foreign regulatory authorities may disagree with the design, endpoints or implementation of our clinical trials;

	●	the population studied in the clinical program may not be sufficiently broad or representative to assure safety or efficacy in the full population for which we seek approval;

	●	the FDA or comparable foreign regulatory authorities may require additional preclinical studies or clinical trials beyond those that we currently anticipate;

	●	the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;

	●	the data collected from clinical trials of product candidates that we may identify and pursue may not be sufficient to support the submission of an NDA or BLA, or other submission for regulatory approval in the United States or elsewhere;

	●	we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;

	●	the FDA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

	●	the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders the clinical trial design or data insufficient for approval.

	●	issue warning letters that would result in adverse publicity;
	●	impose civil or criminal penalties;
	●	suspend or withdraw regulatory approvals;
	●	suspend any of our ongoing clinical trials;
	●	refuse to approve pending applications or supplements to approved applications submitted by us;
	●	impose restrictions on our operations, including closing our CMOs’ facilities;
	●	seize or detain products; or
	●	require a product recall.

	●	reliance on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing processes and the oversight by the third party of its suppliers;
	●	reliance on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs;
	●	the possible breach of the manufacturing agreement by the third party;
	●	the possible misappropriation of proprietary information, including trade secrets and know-how; and
	●	the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

	●	significant time and effort from our management team;
	●	coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and
	●	effective allocation of our resources to multiple projects.

	●	collaborators may have significant discretion in determining the efforts and resources that they will apply to collaborations;
	●	collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their internal development of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
	●	collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
	●	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
	●	a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
	●	we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;
	●	collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
	●	disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future product candidates or that results in costly litigation or arbitration that diverts management attention and resources;
	●	collaborations may be terminated, which may result in a need for additional capital to pursue further development or commercialization of the applicable current or future product candidates;
	●	collaborators may own or co-own intellectual property covering products that result from our collaboration with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;

	●	disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and
	●	a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

	●	the efficacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals;
	●	the potential and perceived advantages compared to alternative treatments, including any similar generic treatments;
	●	the ability to offer these products for sale at competitive prices;
	●	the ability to offer appropriate patient access programs, such as co-pay assistance;
	●	convenience and ease of dosing and administration compared to alternative treatments;
	●	the clinical indications for which the product candidate is approved by FDA or comparable regulatory agencies;
	●	product labeling or product insert requirements of the FDA or other comparable foreign regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labeling;
	●	restrictions on how the product is distributed;
	●	the timing of market introduction of competitive products;
	●	publicity concerning these products or competing products and treatments;
	●	the strength of marketing and distribution support;
	●	favorable third-party coverage and sufficient reimbursement; and
	●	the prevalence and severity of any side effects or AEs.

	At September 30, 2022
	Actual			Pro Forma			Pro Forma, as Adjusted

Cash	$	636		$	636		$	6,825,634
Warrant Liability		-			-			606,533
Preferred stock, Series C, $.0001 par value; 30,000,000 shares authorized, issued and outstanding on an actual basis and no shares issued and outstanding on a pro forma and proforma as adjusted basis		18,065,735			-			-
Stockholders’ (Deficit) Equity
Preferred stock, Series B, $.0001 par value; 1,000,000 shares authorized, 81,000 shares issued and outstanding on an actual, pro forma and pro forma as adjusted basis		8			8			8
Common stock, $.0001 par value; 1,100,000,000 shares authorized; 1,429,129 shares issued and outstanding on an actual basis; 2,041,612 issued and outstanding on a pro forma basis and 3,374,945 shares issued and outstanding on pro forma as adjusted basis, respectively		143			204			337
Additional paid-in capital		11,922,430			29,988,104			36,206,436
Accumulated deficit		(31,041,348	)		(31,041,348	)		(31,041,348	)
Total stockholders’ (deficit) equity		(19,118,767	)		(1,053,032	)		5,165,433
Total capitalization	$	(1,053,032)		$	(1,053,032	)	$	5,771,966

Assumed offering price per share				$	6.00
Deficiency in net tangible book value per share as of September 30, 2022	$	(13.86	)
Increase per share attributable to the conversion of preferred stock	$	13.28
Pro forma deficiency in net tangible book value per share as of September 30, 2022, before giving effect to this offering	$	(1.48	)
Increase attributable to new investors in this offering	$	2.42
As adjusted, net tangible book value per share after the offering				$	0.94
Dilution per share to new investors				$	5.06

	Shares Purchased*					Total Consideration					Average Price Per
	Number		Percent			Amount		Percent			Share
						(in thousands)
Existing stockholders		2,041,612		60.5	%	$	30,163,102		79.0	%	$	14.77

New investors		1,333,333		39.5	%	$	7,999,998		21.0	%	$	6.00

Totals		3,374,945		100.0	%		38,163,100	$	100.0	%	$	11.31

	●	176,246 shares of our common stock issuable upon the exercise of Warrants. Notwithstanding, such amount of warrants will increase by 262,432 shares of Common Stock (assuming the $5.80 offering price and 1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender in our March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon the consummation of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less than $20.00;

	●	18,641 shares of our common stock issuable upon exercise of options to purchase shares of our common stock outstanding as of September 30, 2022, under our Stock Option Plan, with a weighted-average exercise price of $20.70 per share;

	●	121,521 shares of our common stock reserved for future issuance under our Stock Option Plan; and

	●	The exercise of Warrants contained in the Units.

	●	prevailing market conditions;

	●	our historical performance and capital structure;

	●	estimates of our business potential and earnings prospects;

	●	an overall assessment of our management; and

	●	the consideration of these factors in relation to the market valuation of companies in related businesses.

	Three Months Ended September 30,				Increase (Decrease)
	2022		2021		$			%

General and administrative (G&A) expenses, salaries and share based compensation and professional fees separately stated below	$	77,504	$	10,275	$	67,229			654.3	%
Salaries and share based compensation – G&A		279,206		611,839		(332,633	)		(54.4	)%
Professional fees and share based compensation – G&A		265,542		116,253		149,289			128.4	%
Research and development		456,377		125,947		330,430			262.4	%
Depreciation and amortization		1,988		1,990		(2	)		(0.1	)%
Total operating expenses	$	1,080,617	$	866,304	$	214,313			24.7	%

	Nine Months Ended September 30,				Increase (Decrease)
	2022		2021		$			%

General and administrative (G&A) expenses, salaries and share-based compensation and professional fees separately stated below	$	170,303	$	37,271	$	133,032			356.9	%
Salaries and share-based compensation – G&A		1,184,719		2,964,089		(1,779,370	)		(60.0	)%
Professional fees and share based compensation – G&A		422,574		836,194		(413,620	)		(49.5	)%
Research and development		1,548,830		221,087		1,327,743			600.6	%
Impairment of long-lived assets		-		15,000		(15,000	)		(100.0	)%
Depreciation and amortization		5,967		4,755		1,212			25.5	%
Total operating expenses	$	3,332,393	$	4,078,396	$	(746,003	)		(18.3	)%

	Year Ended December 31,				Increase (Decrease)
	2021		2020		$			%

General and administrative (G&A) expenses, salaries and share-based compensation and professional fees separately stated below	$	79,523	$	26,689	$	52,834			198.0	%
Salaries and share-based compensation – G&A		3,214,987		4,446,043		(1,231,056	)		(27.7	)%
Professional fees and share-based compensation – G&A		916,845		125,570		791,275			630.2	%
Research and development		779,275		-		779,275			NM
Impairment of long-lived assets		16,958		32,136		(15,178	)		(47.2	)%
Depreciation and amortization		6,744		5,301		1,443			27.2	%
Total operating expenses	$	5,014,332	$	4,635,739	$	378,593			8.2	%

	Years Ended December 31,						Increase (Decrease)
	2021			2020			$			%

Net cash used in operating activities	$	(1,604,035	)	$	(190,093	)	$	(1,413,942	)		(743.8	)%
Net cash used in investing activities	$	(21,334	)	$	(34,300	)	$	12,966			37.8	%
Net cash provided by financing activities	$	2,135,025		$	385,000		$	1,750,025			(454.6	)%

	1.	Initiate preclinical IND-enabling studies within 6 months of the Effective Date of the license agreement.

	2.	Select at least one lead ADC candidate within eighteen (18) months of the Effective Date of the license agreement.

	3.	Raise at least a total of $500,000 within twenty-two (22) months of the Effective Date of the license agreement.

	4.	IND submission within twenty-four (24) months of the Effective Date of the license agreement.

	1.	Evaluate m900 and m906 to further character the ADCs and determine their stability, solubility, etc.

	2.	Select one of the two antibodies for further development and select one or two leads for IND consideration by the expiration of the license agreement.

	1.	On or before five (5) months from the Effective Date (February 2, 2021), initiate any pre-clinical study activities, as needed, under target points 2.1 and 3.1 in the Commercial Development Plan (described below). This has been completed by the Company.

	2.	On or before twenty-four (24) months from the Effective Date, complete a Phase 1 Clinical Study for initiate a Phase 2 Clinical Study for treatment of a first indicated disease within the Field of Use using a Licensed Product.

	3.	On or before thirty-six (36) months from the Effective Date, complete a Phase 2 Clinical Study or initiate a Phase 3 Clinical Study for the treatment of a first indicated disease within the Field of Use using a Licensed Product.

	4.	On or before forty-eight (48) months from the Effective Date, complete a First Commercial Sale of a Licensed Product to treat a first indicated disease within a Field of Use.

	5.	On or before sixty (60) months from the Effective Date, initiate clinical studies for treatment of an at least second indicated disease within the Field of Use using a Licensed Product.

	6.	On or before one hundred and twenty (120) months, complete a First commercial Sale of a Licensed Product to treat at least a second indicated disease with the Field of Use.

	1.	Gap analysis will be performed on the information provided by the National Eye Institute too assess development requirements for pre-IND and IND preparation.

	2.	We are required to utilize certain consultants with sufficient training to perform certain chemistry, manufacturing and control processes.

	3.	Create and analyze a clinical development strategy.

	4.	Target point 2.1 of the Commercial Development Plan sets forth certain process development, analytics and formulation for first in human GMP manufacturing.

	5.	Target points 3.1 and 3.2 of the Commercial Development Plan set forth certain manufacturing, IND and clinical initiation plans.

	6.	Target point 4.1 sets forth future manufacturing and development plans, including Phase 1.

	7.	Target point 4.2 through 7.1 sets forth future manufacturing and development plans, including potential Phase 2, Phase 3, and NDA (New Drug Application) submissions

	●	Phase 1. The investigational product is initially introduced into patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early indications of effectiveness.

	●	Phase 2. The investigational product is administered to a limited patient population to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

	●	Phase 3. The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval

Description of Securities	Exercise Price		Expiration Date	Price Adjustment
Consultant / Employee Warrants
10,000 Warrants	$	40.00	5/20/2026	Stock Splits and Dividends
12,500 Warrants	$	80.00	6/11/2024	Stock Splits and Dividends
1,250 Warrants (1)	$	49.60	7/14/2024	Stock Splits and Dividends
Offering Warrants
1,000 Warrants	$	20.00	12/3/2023	Stock Splits, Dividends and Fundamental Transactions
12,500 Warrants	$	44.00	5/21/2026	Stock Splits and Dividends
312 Warrants	$	60.00	7/9/2024	Stock Splits and Dividends
7,500 Warrants	$	60.00	8/18/2024	Stock Splits and Dividends
2,777 Warrants	$	56.00	8/19/2024	Stock Splits and Dividends
1,008 Warrants	$	44.00	11/12/2024	Stock Splits and Dividends
30,365 Warrants	$	36.00	Dec. 2024	Stock Splits and Dividends
30,365 Warrants	$	60.00	Dec. 2024	Stock Splits and Dividends
66,666 Warrants	$	0.0001	3/4/2027	N/A

●	any derivative action or proceeding brought on our behalf;

●	any action asserting a claim of breach of a fiduciary duty;

●	any action asserting a claim against us arising pursuant to any provision of the Florida Business Corporation Act (“FBCA”), our amended and restated certificate of incorporation or our amended and restated bylaws; or

●	any action asserting a claim against us that is governed by the internal affairs doctrine.

Plan category	Number of securities to be issued upon exercise of outstanding options, warrants and rights(a)	Weighted average exercise price of outstanding options, warrants and rights ($)	Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)

Plans approved by our stockholders:	—	—	—
2021 Equity Incentive Plan (1)	21,141	20.70	123,677
Plans not approved by stockholders