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

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 10-Q

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(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2023

 

OR

 

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to

 

Commission File Number: 001-38634

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Reviva Pharmaceuticals Holdings, Inc.

(Exact name of registrant as specified in its charter)

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Delaware	85-4306526
(State or other jurisdiction of	(I.R.S. Employer Identification No.)
incorporation or organization)
19925 Stevens Creek Blvd., Suite 100
Cupertino, CA	95014
(Address of principal executive offices)	(Zip Code)

 

[phone]

(Registrant’s telephone number, including area code)

 

Not applicable

(Former name, former address and former fiscal year,

if changed since last report)

 

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

 

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	RVPH	The Nasdaq Capital Market
Warrants to purchase one share of Common Stock	RVPHW	The Nasdaq Capital Market

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Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

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

 

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

 

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

 

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

 

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

 

As of August 11, 2023 the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was 22,650,266.

 

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

FORM 10-Q TABLE OF CONTENTS

 

		Page
Part I Financial Information
Item 1.	Financial Statements (unaudited)	F-1
	Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022 (unaudited)	F-1
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2023 and 2022 (unaudited)	F-2
	Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022 (unaudited)	F-3
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022 (unaudited)	F-5
	Notes to Condensed Consolidated Financial Statements (unaudited)	F-6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	12
Item 4.	Controls and Procedures	12
Part II Other Information
Item 1.	Legal Proceedings	14
Item 1A.	Risk Factors	14
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	14
Item 3.	Defaults Upon Senior Securities	14
Item 4.	Mine Safety Disclosures	14
Item 5.	Other Information	14
Item 6.	Exhibits	15
Signatures		16

 

 

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PART 1. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS (Unaudited)

 

REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

 

June 30, 2023 and December 31, 2022

 

		June 30,				December 31,
		2023				2022
Assets
Cash and cash equivalents		$	11,151,582			$	18,519,856
Prepaid expenses and other current assets			690,440				403,819
Total Assets		$	11,842,022			$	18,923,675
Liabilities and Stockholders' Equity
Liabilities
Short-term debt		$	222,500			$	—
Accounts payable			2,648,287				3,520,271
Accrued expenses and other current liabilities			6,337,558				2,519,569
Total current liabilities			9,208,345				6,039,840
Warrant liabilities			1,012,490				567,439
Total Liabilities			10,220,835				6,607,279
Commitments and contingencies (Note 8)
Stockholders' equity
Common stock, par value of $0.0001; 115,000,000 shares authorized; 22,650,266 and 20,447,371 shares issued and outstanding as of June 30, 2023, and December 31, 2022, respectively			2,265				2,045
Additional paid-in capital			111,835,588				103,485,612
Accumulated deficit			(110,216,666	)			(91,171,261	)
Total stockholders' equity			1,621,187				12,316,396
Total Liabilities and Stockholders' Equity		$	11,842,022			$	18,923,675

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-1

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

 

For the Three and Six Months Ended June 30, 2023 and 2022

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Operating expenses
Research and development		$	8,991,250			$	4,514,389			$	14,226,249			$	10,344,407
General and administrative			3,079,301				1,005,099				4,579,855				2,625,238
Total operating expenses			12,070,551				5,519,488				18,806,104				12,969,645
Loss from operations			(12,070,551	)			(5,519,488	)			(18,806,104	)			(12,969,645	)
Other (expense) income
(Loss) gain on remeasurement of warrant liabilities			(456,177	)			178,021				(445,051	)			267,031
Interest expense			(12,759	)			—				(20,414	)			—
Interest income			103,080				13,825				250,091				15,560
Other expense			(19	)			(6,141	)			(14,513	)			(8,108	)
Total other (expense) income, net			(365,875	)			185,705				(229,887	)			274,483
Loss before provision for income taxes			(12,436,426	)			(5,333,783	)			(19,035,991	)			(12,695,162	)
Provision for income taxes			6,436				6,921				9,414				10,550
Net loss		$	(12,442,862	)		$	(5,340,704	)		$	(19,045,405	)		$	(12,705,712	)
Net loss per share:
Basic and diluted		$	(0.55	)		$	(0.29	)		$	(0.86	)		$	(0.69	)
Weighted average shares outstanding
Basic and diluted			22,434,781				18,466,586				22,135,850				18,466,586

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-2

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)

 

For the Three and Six Months Ended June 30, 2023

 

										Additional								Total
		Common Stock								Paid-In				Accumulated				Stockholders'
Three Months Ended June 30, 2023		Shares				Amount				Capital				Deficit				Equity
Balance at March 31, 2023			20,452,121			$	2,045			$	103,556,732			$	(97,773,804	)		$	5,784,973
Common stock issued in connection with warrant exercises			2,198,145				220				5,658,037				—				5,658,257
Stock-based compensation expense			—				—				2,620,819				—				2,620,819
Net loss			—				—				—				(12,442,862	)			(12,442,862	)
Balance at June 30, 2023			22,650,266			$	2,265			$	111,835,588			$	(110,216,666	)		$	1,621,187

 

 

										Additional								Total
		Common Stock								Paid-In				Accumulated				Stockholders'
Six Months Ended June 30, 2023		Shares				Amount				Capital				Deficit				Equity
Balance at December 31, 2022			20,447,371			$	2,045			$	103,485,612			$	(91,171,261	)		$	12,316,396
Common stock issued in connection with warrant exercises			2,202,895				220				5,677,630				—				5,677,850
Stock-based compensation expense			—				—				2,672,346				—				2,672,346
Net loss			—				—				—				(19,045,405	)			(19,045,405	)
Balance at June 30, 2023			22,650,266			$	2,265			$	111,835,588			$	(110,216,666	)		$	1,621,187

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-3

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)

 

For the Three and Six Months Ended June 30, 2022

 

										Additional								Total
		Common Stock								Paid-In				Accumulated				Stockholders'
Three Months Ended June 30, 2022		Shares				Amount				Capital				Deficit				Equity
Balance at March 31, 2022			15,133,286			$	1,513			$	95,556,672			$	(74,196,977	)		$	21,361,208
Stock-based compensation expense			—				—				39,876				—				39,876
Net loss			—				—				—				(5,340,704	)			(5,340,704	)
Balance at June 30, 2022			15,133,286			$	1,513			$	95,596,548			$	(79,537,681	)		$	16,060,380

 

 

										Additional								Total
		Common Stock								Paid-In				Accumulated				Stockholders'
Six Months Ended June 30, 2022		Shares				Amount				Capital				Deficit				Equity
Balance at December 31, 2021			14,433,286			$	1,443			$	95,516,986			$	(66,831,969	)		$	28,686,460
Common stock issued in connection with warrant exercises			700,000				70				—				—				70
Stock-based compensation expense			—				—				79,562				—				79,562
Net loss			—				—				—				(12,705,712	)			(12,705,712	)
Balance at June 30, 2022			15,133,286			$	1,513			$	95,596,548			$	(79,537,681	)		$	16,060,380

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-4

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

For the Six Months Ended June 30, 2023 and 2022

 

		Six Months Ended June 30,
		2023				2022
Cash flows from operating activities
Net loss		$	(19,045,405	)		$	(12,705,712	)
Adjustments to reconcile net loss to net cash used in operating activities
Change in fair value of warrant liabilities			445,051				(267,031	)
Stock-based compensation expense			2,672,346				79,562
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			(286,621	)			661,972
Accounts payable			(871,984	)			1,874,328
Accrued expenses and other current liabilities			3,817,989				88,929
Net cash used in operating activities			(13,268,624	)			(10,267,952	)
Cash flows from financing activities
Proceeds from issuance of short-term debt			667,500				—
Repayment of short-term debt			(445,000	)			—
Proceeds from exercise of warrants			5,677,850				70
Net cash provided by financing activities			5,900,350				70
Net decrease in cash and cash equivalents			(7,368,274	)			(10,267,882	)
Cash and cash equivalents, beginning of period			18,519,856				29,687,944
Cash and cash equivalents, end of period		$	11,151,582			$	19,420,062
Supplemental disclosures of cash flow information:
Cash paid for taxes		$	3,941			$	3,981
Cash paid for interest		$	20,414			$	—
Prepaid expenses included in accounts payable		$	—			$	169,314

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

F-5

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REVIVA PHARMACEUTICALS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

 

1.   ORGANIZATION AND NATURE OF OPERATIONS

 

On December 14, 2020, Reviva Pharmaceuticals Holdings, Inc. (the “Company”), a Delaware corporation and the successor by re-domiciliation to Tenzing Acquisition Corp. (“Tenzing”), a British Virgin Islands exempted company, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiary), consummated a business combination (the “Business Combination”) through the merger of Merger Sub with and into Reviva Pharmaceuticals, Inc. (the “Merger”), in accordance with the Agreement and Plan of Merger, dated as of July 20, 2020 (the “Merger Agreement”), by and among Tenzing, Merger Sub, Reviva Pharmaceuticals, Inc., and the other parties thereto. Pursuant to the Merger Agreement, at the effective time of the Merger, Merger Sub merged with and into Reviva Pharmaceuticals, Inc., with Reviva Pharmaceuticals, Inc. as the surviving company in the Merger and, after giving effect to such Merger, Reviva Pharmaceuticals, Inc. becoming a wholly-owned subsidiary of Reviva Pharmaceuticals Holdings, Inc. In these notes to the condensed consolidated financial statements, unless otherwise specified or the context indicates otherwise, references to the “Company,” “Reviva,” “we,” “us” and “our” refer to Reviva Pharmaceuticals Holdings, Inc. and its consolidated subsidiaries.

 

Reviva Pharmaceuticals, Inc. was originally incorporated in the state of Delaware and commenced operations on May 1, 2006 and its Indian subsidiary, Reviva Pharmaceuticals India Pvt. Ltd. was incorporated in 2014. The Company is a late-stage pharmaceutical company developing new therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases.

 

 

 

2.   SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2023.

 

The condensed consolidated balance sheet as of December 31, 2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2023.

 

Liquidity and Going Concern

 

The Company has incurred losses since inception and as of June 30, 2023, the Company had working capital of approximately $2.6 million, an accumulated deficit of $110.2 million and cash and cash equivalents on hand of approximately $11.2 million. The Company’s net loss for the three months ended June 30, 2023 and 2022, was approximately $12.4 million and $5.3 million, respectively. The Company's net loss for the six months ended June 30, 2023 and 2022, was approximately $19.0 million and $12.7 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so.

 

F-6

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The Company obtained financing for certain Director & Officer liability insurance policy premiums from First Insurance Funding (the “Lender”). The total premiums, taxes, and fees financed is $667,500 with an annual percentage interest rate of 8.735%. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on the condensed consolidated balance sheet, with the last quarterly installment payment due on October 1, 2023.

 

The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern.

 

Use of estimates

 

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, depreciative and amortization useful lives, assumptions used to calculate the fair value of stock-based compensation, warrant values, deferred taxes, and related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances.

 

Concentration of credit risk and other risks and uncertainties

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. Currently, substantially all the Company’s cash and cash equivalents are held in demand deposit form at two financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash.

 

The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of products in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors.

 

Impact of COVID-19

 

In response to the spread of COVID-19, the Company has taken temporary precautionary measures intended to help minimize the risk of the virus to its employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for the Company’s employees.

 

As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, the Company may experience disruptions that could adversely impact the Company’s business. Effects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. Effects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that the Company intends to rely upon to assist it in conducting its clinical trials and the contract manufacturers who manufacture the Company’s drug candidates.

 

F-7

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The Company is continuing to assess the potential impact of the continuing and lasting effects of the COVID-19 pandemic on its business and operations as of June 30, 2023.

 

 

 

3. EMPLOYEE BENEFIT PLAN

 

In 2014, Reviva Pharmaceuticals, Inc. implemented a tax deferred savings plan, commonly referred to as a 401(k) plan. Employee’s contributions are withheld from standard payroll checks and are automatically withdrawn from the Company checking account and deposited into individual employee retirement accounts a few days following each payroll period. Employees can defer or contribute the statutory legal limits. There has been no Company matching of employee contributions to the plan through June 30, 2023.

 

 

 

4.   LOSS PER SHARE

 

Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share includes potentially dilutive securities such as stock options, warrants to purchase common stock, and other convertible instruments unless the result of inclusion would be anti-dilutive. These securities have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022, because all such securities are anti-dilutive for all periods presented.

 

The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Shares issuable upon exercise of stock options			1,547,774				192,898				1,547,774				192,898
Shares issuable upon exercise of warrants to purchase common stock			15,030,209				13,883,732				15,030,209				13,883,732
Shares contingently issuable for earnout			1,000,000				1,000,000				1,000,000				1,000,000
			17,577,983				15,076,630				17,577,983				15,076,630

 

The diluted loss per share computation equals basic loss per share for the three and six months ended June 30, 2023 and 2022 because the Company had a net loss and the impact of the assumed exercise of stock options and warrants would have been anti-dilutive.

 

 

 

5.   WARRANTS

 

As of June 30, 2023, there were public warrants outstanding to purchase an aggregate of 6,325,000 shares of common stock, private warrants outstanding to purchase an aggregate of 1,939,712 shares of common stock, investor warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock, private pre-funded warrants to purchase an aggregate of 1,383,399 shares of common stock, and assumed warrants outstanding to purchase an aggregate of 120,456 shares of common stock.

 

2020 Business Combination

 

In connection with the closing of our Business Combination in 2020, our predecessor company, Tenzing, issued public warrants to purchase 6,325,000 shares and private placement warrants to purchase 556,313 shares.

 

F-8

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Further, there were assumed warrants to purchase an aggregate of 126,268 shares of common stock, of which 5,812 expired during fiscal year 2022. These warrants were classified as equity as of June 30, 2023 and June 30, 2022. The fair value of these warrants on the date of issuance was $1,279,182.

 

Each public warrant entitles the holder thereof to purchase one share of common stock at a price of $11.50 per share, subject to adjustment. No public warrants will be exercisable for cash unless we have an effective and current registration statement covering the issuance of the shares of common stock issuable upon exercise of the public warrants and a current prospectus relating to such shares of common stock.

 

We may call the public warrants for redemption, in whole and not in part, at a price of $0.01 per warrant;

 

•

if, and only if, the reported last sale price of the common stock equals or exceeds $21.00 per share (as adjusted for stock splits, stock dividends, reorganizations and recapitalizations), for any 20 trading days within a 30 trading day period ending on the third trading business day prior to the notice of redemption to holders of the public warrants, and

 

•

if, and only if, there is a current registration statement in effect with respect to the issuance of the shares of common stock underlying such Public Warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption

 

•

at any time while the public warrants are exercisable

 

•

upon not less than 30 days’ prior written notice of redemption to each warrant holder

 

The private warrants are substantially similar to the public warrants except such private warrants;

 

•

are exercisable for cash or on a cashless basis, at the holder’s option

 

•

cannot be redeemed by us, so long as they are still held by the initial purchasers or their affiliates.

 

•

The redemption price is to be calculated as the 10-day average trading price ending one trading business day prior to the notice of redemption.

 

In no event will the Company be required to net cash settle either the public or the private warrants.

 

The exercise price and number of shares of common stock issuable on exercise of the warrants may be adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or a recapitalization, reorganization, merger or consolidation. The private warrants were classified as derivative liabilities pursuant to ASC 815 (see to Note 9).

 

2021 Public Offering

 

In connection with the Company’s public offering of units completed on June 1, 2021, the Company issued pre-funded warrants (“2021 Pre-Funded Warrants”) exercisable for 5,066,600 shares of common stock and warrants (“2021 Investor Warrants”) exercisable for 6,900,000 shares of common stock.

 

During fiscal year 2021, 1,033,300 of the 2021 Pre-Funded Warrants were exercised for $103 in proceeds, resulting in the issuance of 1,033,300 common shares. During fiscal year 2022, 4,033,300 of the 2021 Pre-Funded Warrants were exercised for $403 in proceeds, resulting in the issuance of 4,033,300 common shares. There were no 2021 Pre-Funded Warrants outstanding as of June 30, 2023.

 

During fiscal year 2022, 6,000 of the 2021 Investor Warrants were exercised for $18,563 in proceeds, resulting in the issuance of 4,500 shares of common stock. During the three months ended June 30, 2023, 295,816 of the 2021 Investor Warrants were exercised for $915,173 in proceeds, resulting in the issuance of 221,860 shares of common stock. During the six months ended June 30, 2023, 302,150 of the 2021 Investor Warrants were exercised for $934,766 in proceeds, resulting in the issuance of 226,610 shares of common stock. As of June 30, 2023, there are 2021 Investor Warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock.

 

F-9

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2022 Registered Direct Offering and Private Placement

 

On September 8, 2022, the Company completed a registered direct offering and concurrent private placement (the “September 2022 Offering”). In connection with this offering, the Company issued to investors warrants (the “2022 Private Placement Warrants”) to purchase up to 3,359,684 shares of common stock. The 2022 Private Placement Warrants were immediately exercisable upon issuance.

 

In a concurrent private placement, the Company issued pre-funded warrants (the “2022 Private Pre-Funded Warrants”) to purchase up to an aggregate of 1,383,399 shares of common stock. The 2022 Private Pre-Funded Warrants were immediately exercisable.

 

During the three and six months ended June 30, 2023, an aggregate of 1,976,285 of the 2022 Private Placement Warrants were exercised for $4,743,084 in proceeds, resulting in the issuance of 1,976,285 shares of common stock. As of June 30, 2023, there are 1,383,399 of the 2022 Private Placement Warrants outstanding to purchase an aggregate of 1,383,399 shares of common stock. No 2022 Private Pre-Funded Warrants issued during the September 2022 Offering have been exercised as of June 30, 2023.

 

The Company has determined that as the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants were issued at fair value in an offering transaction in tandem with shares of equity with no debt funding included in the offering, the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants should be classified as equity.

 

The fair value of the 2022 Private Placement Warrants and 2022 Private Pre-Funded Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., Company share price of $2.20, exercise price of $2.40 for the 2022 Private Placement Warrants and $0.0001 for the 2022 Private Pre-Funded Warrants, term of 5 years, volatility of 111%, risk-free rate of 3.4%, and expected dividend rate of 0%). The grant date relative fair value of these warrants was estimated to be $5,712,592 on September 8, 2022 and are classified as equity.

 

The Company evaluated the 2022 Private Placement Warrants and the 2022 Private Pre-Funded Warrants in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging, and determined that they should be classified as equity instruments, with no recurring fair value measurement required. The warrants are indexed to the Company’s common stock and are required to be settled through physical settlement or net share settlement, if exercised. Accordingly, the warrants were recorded at their grant date fair value with no subsequent remeasurement.

 

 

 

6.  STOCK-BASED COMPENSATION

 

Stock-Based Compensation Expense

 

On April 25, 2023, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) approved the grant of option awards to certain of the Company's officers and employees in accordance with the terms of the Company’s 2020 Equity Incentive Plan ("2020 Plan"). The Compensation Committee's approval included options granted to purchase a total of 1,303,000 shares of common stock to the Company's executive officers and other employees of the Company. All of the options were granted pursuant to the 2020 Plan and have an exercise price of $6.74 per share, based on the closing price of the common stock on the grant date in accordance with the terms of the 2020 Plan. The options granted to the named executive officers and Vice President for Program & Portfolio Management were immediately vested as to 50% of the shares subject thereto on the grant date, and will vest as to an additional 1.389% of the shares subject thereto on the last day of each month thereafter and have a ten-year expiration date. The options granted to the other employees have varying vesting terms between three and four years.

 

F-10

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The Company records stock-based compensation expense in connection with the amortization of the fair value of stock options granted to employees, non-employee consultants and non-employee directors. During the three months ended June 30, 2023 and 2022, the Company recorded stock-based compensation of $2,620,819 and $39,876 respectively. During the six months ended June 30, 2023 and 2022, the Company recorded stock-based compensation of $2,672,346 and $79,562 respectively. As of June 30, 2023, the Company had unrecognized stock-based compensation expense of $4,188,195, which is expected to be recognized over a weighted-average period of 3.0 years. As of June 30, 2023, there are 0 and 1,297,063 shares of common stock available for issuance under the 2006 Equity Incentive Plan and the 2020 Plan, respectively.

 

Determining Fair Value

 

Valuation and Recognition – The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes pricing model utilizes the following assumptions:

 

Expected Term – Expected life of an option award is the average length of time over which the Company expects employees will exercise their options, which is based on historical experience with similar grants.

 

Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the awards.

 

Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent expected term.

 

Dividend Yield – The Company has not paid a dividend and does not anticipate paying a dividend in the foreseeable future.

 

There were no options granted during the six months ended June 30, 2022. The value of option grants is calculated using the Black-Scholes option pricing model with the following assumptions for options granted during the six months ended June 30, 2023:

 

		June 30, 2023
Risk-free interest rate			3.43%
Expected term (in years)		5.37	-	6.05
Expected volatility		86.64%	-	88.56%
Expected dividend yield			0%

 

Activity under the stock plans for the six months ended June 30, 2023, is as follows:

 

		Shares Available for Grant				Number of Options Outstanding				Weighted Average Exercise price per share				Weighted Average Remaining Contractual Term in Years				Aggregate Intrinsic Value
Balance, December 31, 2022			2,600,063				244,774			$	6.32				8.62			$	—
Granted			(1,303,000	)			1,303,000			$	6.74
Balance, June 30, 2023			1,297,063				1,547,774			$	6.67				9.55			$	314,468
Options exercisable at June 30, 2023							622,027			$	6.96				9.32			$	188,850

 

The options granted had a $4.90 weighted average grant date fair value during the six months ended June 30, 2023.

 

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7.   SHORT-TERM DEBT

 

Insurance Funding

 

The Company obtained financing for certain Director & Officer liability insurance policy premiums. The governing agreement assigns the Lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies.

 

The total premiums, taxes and fees financed is $667,500 with an annual interest rate of 8.735%. In consideration of the premium payment by the Lender to the insurance companies or the agent or broker, the Company unconditionally promises to pay the Lender the amount financed plus interest and other charges permitted under the governing agreement. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on its condensed consolidated balance sheet. The Company will pay the remaining insurance financing through the last quarterly installment payment on October 1, 2023.

 

 

 

8.   COMMITMENTS AND CONTINGENCIES

 

Clinical trials

 

Since 2010, the Company has entered into multiple clinical trial agreements with medical institutions in the United States, Europe and Asia for the purpose of enrolling patients into various clinical trials. The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, the amount to be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions. The clinical trial services provided by each site generally include the screening of prospective patients and, for those patients to be enrolled in the study, administration of the Company’s investigation drug according to the trial protocol, any required hospitalization, ancillary medical supplies, and 2-week patient follow-up. Further, each agreement requires the Company to indemnify each respective clinical site against any and all liability, loss, or damage it may suffer as a result of third-party claims; the Company maintains product liability insurance of not less than $10 million in conjunction with this indemnification. The agreements may be terminated upon 30 days’ written notice, subject to conditions of paying all liabilities incurred through the date of termination. Additionally, with each screened patient, the Company incurs expense with other entities engaged to provide independent review of patient medical records.

 

As part of the Company's agreement with one of its clinical research organizations, the Company is required to maintain a 7% upfront float for fees related to expenses incurred in clinical studies. When the float has depleted to 15% (i.e. 85% of the float has been used) the Company will receive an invoice to replenish the float up to 7% of the remaining estimated budget for the studies. During the three months ended June 30, 2023, the Company did not make any additional payments to replenish the float and expensed approximately $0.7 million. During the six months ended June 30, 2023, the Company paid approximately $0.9 million to replenish the float and expensed approximately $1.0 million. As of June 30, 2023, the Company has no remaining prepaid float balance.

 

Indemnification

 

From time to time, in its normal course of business, the Company may indemnify other parties, with whom it enters into contractual relationships, including lessors and parties to other transactions with the Company. The Company may agree to hold other parties harmless against specific losses, such as those that could arise from a breach of representation, covenant or third-party infringement claims. It may not be possible to determine the maximum potential amount of liability under such indemnification obligations due to the unique facts and circumstances that are likely to be involved in each particular claim and indemnification provision. Historically, there have been no such indemnification claims. The Company has also indemnified its directors and executive officers, to the extent legally permissible, against all liabilities reasonably incurred in connection with any action in which such individual may be involved by reason of such individual being or having been a director or executive officer.

 

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Operating Leases

 

The Company adopted ASC 842, Leases, on January 1, 2019. The Company has elected to apply the short-term lease exception to leases of one year or less. Presently, the Company has a single twelve-month lease on its Corporate Office located at 19925 Stevens Creek Blvd., Suite 100, Cupertino, CA 95014. The monthly lease payment is approximately $1,447 and the lease was renewed in February 2022 and again on February 1, 2023, for another 12-month term.

 

 

 

9. FAIR VALUE MEASUREMENTS

 

Fair value is defined as 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. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

 

•

Level 1 — Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

 

•

Level 2 — Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.

 

•

Level 3 — Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.

 

The determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

 

The following is a listing of the Company’s warrant liabilities required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of June 30, 2023 and December 31, 2022:

 

		June 30, 2023
		Level 1				Level 2				Level 3				Total
		(unaudited)
Liabilities:
Warrant liability			—				—			$	1,012,490			$	1,012,490
Total		$	—			$	—			$	1,012,490			$	1,012,490

 

		December 31, 2022
		Level 1				Level 2				Level 3				Total
Liabilities:
Warrant liability		$	—			$	—			$	567,439			$	567,439
Total		$	—			$	—			$	567,439			$	567,439

 

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The following table summarizes the changes in the fair value of the warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3):

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
		(unaudited)								(unaudited)
Balance, beginning of period		$	556,313				283,720				567,439			$	372,730
Change in fair value of warrant liability			456,177				(178,021	)			445,051				(267,031	)
Balance, end of period		$	1,012,490			$	105,699			$	1,012,490			$	105,699

 

The Company classified the private warrants pursuant to ASC 815 as derivative liabilities, as the warrants have terms which are modified upon any future transfer of ownership, with subsequent changes in their fair values to be recognized in the consolidated financial statements at each reporting date. The Company calculated the fair value of the private warrants as of June 30, 2023 as $1,012,490 using a Black-Scholes model. The key inputs used in the Black-Scholes calculation were the risk-free interest rate, expected volatility, expected life, exercise price and stock price. The risk-free interest rate was estimated to be 4.70%, the expected volatility was estimated to be 77.90%, and the expected life was estimated to be 2.46 years. The exercise price was $11.50, and the stock price $5.86.

 

The Company recorded a loss on remeasurement of warrant liabilities of $456,177 and a gain of 178,021 for the three months ended June 30, 2023 and 2022, respectively. The Company recorded a loss on remeasurement of warrant liabilities of $445,051 and a gain of $267,031 for the six months ended June 30, 2023 and 2022, respectively.

 

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ITEM 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

All statements other than statements of historical fact included in this section regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward- looking statements. When used in this section, words such “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to our management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those contemplated by the forward- looking statements as a result of certain factors detailed herein. All such forward-looking statements, and all subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph and the "Cautionary Note Regarding Forward-Looking Statements" below.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

 

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

 

•

the success of our current or planned clinical trials through all phases of clinical development, including our ability to conduct and complete clinical trials in accordance with projected timelines, our ability to achieve the desired results, and our ability to successfully complete requisite regulatory review and approval processes;

 

•

our ability to grow and manage growth economically;

 

•

our ability to retain key executives and medical and science personnel;

 

•

the possibility that our products in development succeed in or fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable authorities;

 

•

the possibility that we could be forced to delay, reduce or eliminate our planned clinical trials or development programs;

 

•

our ability to obtain approval from regulatory agencies in different jurisdictions for our current or future product candidates;

 

•

changes in applicable laws or regulations;

 

•

changes to our relationships within the pharmaceutical ecosystem;

 

•

the performance of third-party suppliers and manufacturers and our ability to find additional suppliers and manufacturers and obtain alternative sources of raw materials;

 

•

our ability and the potential to successfully manufacture our product candidates for pre-clinical use, for clinical trials and, if approved, on a larger scale for commercial use;

 

•

our current and future capital requirements to support our development and commercialization efforts and our ability to satisfy our capital needs;

 

•

our ability to access capital on acceptable terms in a rising interest rate and tighter credit environment;

 

•

expectations regarding our ability to continue as a going concern;

 

•

the accuracy of our estimates regarding expenses and capital requirements, including estimated costs of our clinical studies;

 

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•

our limited operating history;

 

•

our history of operating losses in each year since inception and expectation that we will continue to incur operating losses for the foreseeable future;

 

•

changes in the markets that we target;

 

•

continuing uncertainties associated with the ongoing impact and uncertain effect of COVID-19 or other future pandemics or events, and related responses of businesses and governments to COVID-19 or other future pandemics or events, on our operations including our clinical trials and on our personnel and those of any third party service providers upon which we rely, on commercial activity in the markets in which we operate and on our results of operations;

 

•

our ability to meet the continued listing requirements for the listing of our common stock and listed warrants on Nasdaq;

 

•

our ability to maintain or protect the validity of our patents and other intellectual property;

 

•

our exposure to any liability, protracted and costly litigation or reputational damage relating to data security;

 

•

our ability to maintain effective internal controls; and

 

•

the possibility that we may be adversely affected by other economic, business, and/or competitive factors.

 

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

 

Company Overview

 

We are a late-stage pharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing significant unmet medical needs and burdens to society, patients, and their families. Our current pipeline focuses on the central nervous system, inflammatory, and cardiometabolic diseases. We use a chemical genomics driven technology platform and proprietary chemistry to develop new medicines. Our pipeline currently has two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. We have been granted composition of matter patents for both brilaroxazine and RP1208 in the United States (U.S.), Europe, and several other countries.

 

Our lead drug candidate, brilaroxazine, is in clinical development and is intended to treat multiple neuropsychiatric indications. These include schizophrenia, bipolar disorder (BD), major depressive disorder (MDD), attention–deficit/hyperactivity disorder (ADHD), behavioral and psychotic symptoms of dementia or Alzheimer’s disease (BPSD), and Parkinson’s disease psychosis. Furthermore, brilaroxazine is also ready for clinical development for two respiratory indications —  pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to brilaroxazine for the treatment of PAH in November 2016 and IPF in April 2018. Brilaroxazine also is in preclinical development for the treatment of psoriasis.

 

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On January 10, 2022, the FDA notified us that we could proceed with our Phase 3 RECOVER trial (the “RECOVER Trial”), which is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. On February 1, 2022, we announced that the first patients in the RECOVER Trial had been dosed. On July 27, 2022, we announced that we had enrolled patients in 15 geographically diverse sites across the U.S.

 

The Company received regulatory approval for initiating the study in Asia (India) on October 11, 2022 and multiple sites were initiated in India in November and December 2022.

 

On October 31, 2022, we announced over 30% enrollment in the RECOVER Trial in the United States and the initiation and ongoing enrollment across sites in Europe, and we finished 2022 with about 40% enrollment. On June 22, 2023, the Company reported that over 80% of patients have been enrolled in the RECOVER Trial, and on August 14, 2023, the Company reported that enrollment was near completion for approximately 400 patients across multiple sites in the Unites States, Europe and Asia for the RECOVER Trial with topline data expected in October 2023.

 

Our primary focus is to complete the clinical development of brilaroxazine for the treatment of acute and maintenance schizophrenia.

 

We are currently developing Phase 2 trial protocols for studies of brilaroxazine in ADHD and PAH and anticipate submitting the protocols to regulatory agencies in the second half of 2023 and initiating the Phase 2 studies in the second half of 2023.

 

Subject to the receipt of additional financing, we may also continue the clinical development of brilaroxazine for the treatment of BD, MDD, BPSD, PDP, and IPF. Moreover, subject to the receipt of additional financing, we may also advance the development of our second drug candidate, RP1208, for the treatment of depression and obesity.

 

Impact of COVID-19

 

In response to the spread of COVID-19, we have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for our employees.

 

As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, we may experience disruptions that could adversely impact our business. Effects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. Effects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that we intend continue to rely upon to assist us in conducting our clinical trials and the contract manufacturers who manufacture our drug candidates.

 

We are continuing to assess the potential impact of the continuing and lasting effects of theCOVID-19 pandemic on our business and operations. For additional information on the various risks posed by the COVID-19 pandemic, refer to Part I—Item 1A—Risk Factors of our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2023.

 

Business Combination and Domestication

 

On December 14, 2020, our predecessor company, formerly known as Tenzing Acquisition Corp., a British Virgin Islands exempted company (“Tenzing”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiaries, “Old Reviva”), consummated the transactions (the “Business Combination”) contemplated by the Agreement and Plan of Merger, dated as of July 20, 2020 (as amended, the “Merger Agreement”), by and among Tenzing, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), Old Reviva, and the other parties thereto. Pursuant to the Merger Agreement, Merger Sub merged with and into Old Reviva, with Old Reviva surviving as our wholly owned subsidiary. We refer to this transaction as the Business Combination. In connection with and one day prior to the completion of the Business Combination, Tenzing re-domiciled out of the British Virgin Islands and continued as a company incorporated in the State of Delaware, and changed its name to Reviva Pharmaceuticals Holdings, Inc. Prior to the completion of the Business Combination, the Company was a shell company. Following the Business Combination, the business of Old Reviva is the business of the Company.

 

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Old Reviva was incorporated in the state of Delaware on May 1, 2006 and its subsidiary, Reviva Pharmaceuticals India Pvt. Ltd., was incorporated on December 23, 2014. Tenzing was formed pursuant to the laws of the British Virgin Islands on March 20, 2018.

 

Financial Overview

 

We are a clinical-stage biopharmaceutical company and have not generated any revenues from the sale of products. We have never been profitable, and our accumulated deficit as of June 30, 2023, was $110.2 million. Our net loss for the three months ended June 30, 2023 and 2022, was approximately $12.4 million and $5.3 million, respectively. Our net loss for the six months ended June 30, 2023 and 2022, was approximately $19.0 million and $12.7 million, respectively. We expect to incur significant expenses and increased operating losses for the next several years. We expect our expenses to increase in connection with our ongoing activities to research, develop and commercialize our product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company. We will need to generate significant revenues to achieve profitability, and we may never do so.

 

We expect our expenses will increase substantially in connection with our ongoing activities, as we:

 

•

invest significantly to further research and develop, through clinical trials for RP5063 (Brilaroxazine) and pre-clinical research for RP1208, and seek regulatory approval for our product candidates RP5063 (Brilaroxazine) and RP1208;

 

•

identify and develop additional product candidates;

 

•

hire additional clinical, scientific and management personnel;

 

•

seek regulatory and marketing approvals for any product candidates that we may develop;

 

•

ultimately establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;

 

•

maintain, expand and protect our intellectual property portfolio;

 

•

acquire or in-license other drugs and technologies; and

 

•

add operational, financial and management information systems and personnel, including personnel to support our product candidate development, any future commercialization efforts, and our ongoing compliance with and maintenance of public company controls, procedures and regulatory requirements and standards.

 

We have funded our operations to date primarily from the issuance and sale of our equity and convertible equity securities. As of June 30, 2023, we had cash and cash equivalents of approximately $11.2 million. To fund our current operating plans, we will need to raise additional capital. Our existing cash and cash equivalents will not be sufficient for us to complete development of our product candidates and, if applicable, to prepare for commercializing any product candidate that may receive approval. Accordingly, we will continue to require substantial additional capital beyond our existing cash to continue our clinical development and potential commercialization activities. We believe that we have adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date the financial statements are issued. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition, and our ability to pursue our business strategy, and our ability to continue as a going concern. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

 

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Research and Development Expenses

 

We focus our resources on research and development activities, including the conduct of preclinical and clinical studies and product development and expense such costs as they are incurred. We have not historically tracked or recorded research and development expenses on a project-by-project basis, primarily because we use our employee and infrastructure resources across multiple research and development projects, and it is not practical for us to allocate such costs on a project-by-project basis. Our research and development expenses primarily consist of employee-related expenses, including salaries, benefits and taxes for personnel in research and development functions.

 

The largest recurring component of our total operating expenses has historically been research and development activities. We expect our research and development expenses will increase for the next several years as we advance our development programs, pursues regulatory approval of our product candidates in the U.S. and other jurisdictions and prepare for potential commercialization, which would require a significant investment in costs related to contract manufacturing, inventory buildup and sales and marketing activities.

 

Our primary product candidates and their current status is as follows:

 

Drug Candidate	Indication	Status
Brilaroxazine (RP5063)	Schizophrenia	Initiated pivotal Phase 3 and long-term safety studies. Topline data for the pivotal Phase 3 study is anticipated in October 2023
Brilaroxazine	Bipolar Disorder	Phase 1 complete**
Brilaroxazine	Depression-MDD	Phase 1 complete**
Brilaroxazine	Alzheimer’s (AD-Psychosis/Behavior)	Phase 1 complete**
Brilaroxazine	Parkinson’s	Phase 1 complete**
Brilaroxazine	ADHD/ADD	Phase 1 complete**
Brilaroxazine	PAH	Phase 1 complete**
Brilaroxazine	IPF	Phase 1 complete**
Brilaroxazine	Psoriasis	In pre-clinical development
RP1208	Depression	Completed pre-clinical development studies, including in vitro receptor binding studies, animal efficacy studies, and PK studies. Compound ready for IND enabling studies.
RP1208	Obesity	Completed pre-clinical development studies, including in vitro receptor binding studies and PK studies. Compound ready for animal efficacy studies.

 

** We completed the Phase 1 clinical study for brilaroxazine prior to starting the Phase 2 study in schizophrenia and schizoaffective disorder. We collected safety data for brilaroxazine in over 200 patients, including healthy subjects and patients with stable schizophrenia, acute schizophrenia and schizoaffective disorder. Generally, no separate Phase 1 study is required for conducting a Phase 2 study for an additional indication, provided the treatment doses in the Phase 2 study for an additional indication are within the range of doses tested in the previously completed Phase 1 study.

 

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The successful development of our platform and product candidates is highly uncertain, and we may never succeed in achieving marketing approval for our product candidates RP5063 (Brilaroxazine), RP1208, or any future product candidates. We expect the remaining costs in connection with our ongoing Phase 3 clinical study for brilaroxazine to be approximately $9.2 million as of June 30, 2023, with approximately $5.5 million payable during the rest of calendar 2023, and approximately $3.7 million payable during calendar 2024. At this time, other than our estimates for conducting our Phase 3 clinical study for brilaroxazine, we cannot reasonably estimate the nature, timing, or costs of the efforts necessary to finish developing any of our product candidates or the period in which material net cash, if any, from these product candidates may commence. This is due to the numerous risks and uncertainties associated with developing therapeutics, including the uncertainty of:

 

•	the scope, rate of progress, expense, and results of clinical trials;

 

•	the scope, rate of progress, and expense of process development and manufacturing;

 

•	preclinical and other research activities; and

 

•	the timing of regulatory approvals.

 

General Administrative Expenses

 

General and administrative expenses primarily consist of payroll and related costs for employees in executive, business development, finance, and administrative functions. Other significant general and administrative expenses include professional fees for accounting and legal services.

 

We expect general and administrative expenses to increase as we expand infrastructure and continue the development of our clinical programs. Other increases could potentially include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel, and increased fees for directors, outside consultants, lawyers, and accountants. We expect to incur significant costs to comply with corporate governance, internal controls, and similar requirements applicable to public companies.

 

Interest Income and Other Income

 

Interest income and other, net consists largely of interest earned on our cash & cash equivalents.

 

Critical Accounting Policies and Use of Estimates

 

Our critical accounting policies are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023. Since the date of the Annual Report on Form 10-K, there have been no material changes in our critical accounting policies.

 

7

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Results of Operations

 

Comparison of the three months ended June 30, 2023 and 2022:

 

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

 

		Three Months Ended June 30,								Change				Change
		2023				2022				$				%
Operating expenses
Research and development		$	8,991,250			$	4,514,389				4,476,861				99	%
General and administrative			3,079,301				1,005,099				2,074,202				206	%
Total operating expenses			12,070,551				5,519,488
Loss from operations			(12,070,551	)			(5,519,488	)
(Loss) gain on remeasurement of warrant liabilities			(456,177	)			178,021				(634,198	)			(356	)%
Interest expense			(12,759	)			—				(12,759	)			10000	%
Interest income			103,080				13,825				89,255				646	%
Other expense			(19	)			(6,141	)			6,122				100	%
Total other (expense) income, net			(365,875	)			185,705
Loss before provision for income taxes			(12,436,426	)			(5,333,783	)
Provision for income taxes			6,436				6,921				(485	)			(7	)%
Net loss		$	(12,442,862	)		$	(5,340,704	)

 

Research and Development Expenses

 

We incurred approximately $9.0 million and $4.5 million in research and development expenses for the three months ended June 30, 2023 and 2022, respectively. The primary reason for the increase of $4.5 million, or 99%, was attributable to an increase in Phase 3 clinical trial expenses and drug development costs of approximately $3.0 million for our product candidate brilaroxazine. This is coupled with an increase of approximately $0.9 million in stock-based compensation, an increase of approximately $0.6 million related to safety and toxicology studies and an increase in salaries of approximately $0.5 million. This is slightly offset by a decrease of approximately $0.4 million related to manufacturing and testing expenses, a decrease of approximately $0.1 million related to preclinical expenditures and a decrease of approximately $0.1 million related to recruiting expenses. Our research and development expenses are expected to increase for the foreseeable future as we continue to advance our platform and product candidates.

 

General and Administrative Expenses

 

We incurred approximately $3.1 million and $1.0 million in general and administrative expenses for the three months ended June 30, 2023 and 2022, respectively. The increase of $2.1 million, or 206%, was primarily attributable to increases in stock-based compensation of approximately $1.6 million, legal expenses of approximately $0.3 million, recruiting expenses of approximately $0.1 million, consultant and professional expenses of approximately $0.1 million and salary and board of director compensation totaling approximately $0.1 million. This is slightly offset by a decrease in health and commercial insurance of approximately $0.1 million.

 

(Loss) gain on Remeasurement of Warrant Liabilities

 

The remeasurement of warrant liabilities loss of $0.5 million and gain of $0.2 million for the three months ended June 30, 2023 and 2022, respectively, resulted from the increase in calculated fair value principally as a result of the increase in our stock price during the three months ended June 30, 2023. The gain on remeasurement of warrant liabilities $0.2 million for the three months ended June 30, 2022, resulted from the decrease in calculated fair value principally as a result of the decline in stock price during the three months ended June 30, 2022.

 

8

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Interest Income

 

Interest Income increased primarily due to the Company moving funds to an interest-bearing account in the final months of fiscal year 2022, coupled with an increase in market interest rates in 2023 as compared to 2022.

 

Comparison of the six months ended June 30, 2023 and 2022:

 

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

 

		Six Months Ended June 30,								Change				Change
		2023				2022				$				%
Operating expenses
Research and development		$	14,226,249			$	10,344,407				3,881,842				38	%
General and administrative			4,579,855				2,625,238				1,954,617				74	%
Total operating expenses			18,806,104				12,969,645
Loss from operations			(18,806,104	)			(12,969,645	)
(Loss) gain on remeasurement of warrant liabilities			(445,051	)			267,031				(712,082	)			(267	)%
Interest expense			(20,414	)			—				(20,414	)			10000	%
Interest income			250,091				15,560				234,531				(1507	)%
Other expense			(14,513	)			(8,108	)			(6,405	)			7900	%
Total other (expense) income, net			(229,887	)			274,483
Loss before provision for income taxes			(19,035,991	)			(12,695,162	)
Provision for income taxes			9,414				10,550				(1,136	)			(11	)%
Net loss		$	(19,045,405	)		$	(12,705,712	)

 

Research and Development Expenses

 

We incurred approximately $14.2 million and $10.3 million in research and development expenses for the six months ended June 30, 2023 and 2022, respectively. The primary reason for the increase of $3.9 million, or 38%, was attributable to an increase in Phase 3 clinical trial expenses and higher drug development costs of approximately $1.6 million for our product candidate brilaroxazine. This is coupled with an increase of approximately $1.0 million in stock-based compensation, an increase of approximately $1.0 million related to safety and toxicology studies, an increase in salaries of approximately $0.8 million, and an increase of approximately $0.1 million in consultant expense. This is slightly offset by a decrease of approximately $0.4 million related to manufacturing and testing expenses, a decrease of approximately $0.2 million related to preclinical expenditures and a decrease of approximately $0.1 million related to recruiting and other research and development expenses. Our research and development expenses are expected to increase for the foreseeable future as we continue to advance our platform and product candidates.

 

General and Administrative Expenses

 

We incurred approximately $4.6 million and $2.6 million in general and administrative expenses for the six months ended June 30, 2023 and 2022, respectively. The increase of $2.0 million, or 74%, was primarily attributable to increases in stock-based compensation of approximately $1.6 million, legal expenses of approximately $0.2 million, consultant and professional expenses of approximately $0.2 million, recruiting expenses of approximately $0.1 million and salary and board of director compensation totaling approximately $0.1 million. This is slightly offset by a decrease in health and commercial insurance of approximately $0.2 million.

 

9

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(Loss) gain on Remeasurement of Warrant Liabilities

 

The loss on remeasurement of warrant liabilities of $0.4 million and gain of $0.3 million for the six months ended June 30, 2023 and 2022, respectively, resulted from the increase in calculated fair value principally as a result of the increase in our stock price during the six months ended June 30, 2023. The gain on remeasurement of warrant liabilities $0.3 million for the six months ended June 30, 2022, resulted from the decrease in calculated fair value principally as a result of the decline in stock price during the six months ended June 30, 2022.

 

Interest Income

 

Interest Income increased primarily due to the Company moving funds to an interest-bearing account in the final months of fiscal year 2022, coupled with an increase in market interest rates in 2023 as compared to 2022.

 

Liquidity and Capital Resources

 

		June 30				December 31,				Change
		2023				2022				Dollars				Percentage
Balance Sheet Data:
Cash and cash equivalents		$	11,151,582			$	18,519,856				(7,368,274	)			(39.8	)%
Working capital		$	2,633,677			$	12,883,835				(10,250,158	)			(79.6	)%
Total assets		$	11,842,022			$	18,923,675				(7,081,653	)			(37.4	)%
Total stockholders' equity		$	1,621,187			$	12,316,396				(10,695,209	)			(86.8	)%

 

		Six Months Ended June 30,								Change
Statement of Cash Flow Data:		2023				2022				Dollars				Percentage
Net cash used in operating activities		$	(13,268,624	)		$	(10,267,952	)			(3,000,672	)			29.2	%
Net cash provided by financing activities			5,900,350				70				5,900,280				8428971.4	%
Net decrease in cash and cash equivalents		$	(7,368,274	)		$	(10,267,882	)			2,899,608				(28.2	)%

 

Capital Resources

 

As of June 30, 2023, we had cash and cash equivalents of approximately $11.2 million. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue our research and preclinical and clinical development of our product candidates; expand the scope of our current studies for our product candidates; initiate additional preclinical, clinical or other studies for our product candidates; change or add additional manufacturers or suppliers; seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies; seek to identify, evaluate and validate additional product candidates; acquire or in-license other product candidates and technologies; maintain, protect and expand our intellectual property portfolio; attract and retain skilled personnel; and experience any delays or encounter issues with any of the above.

 

On September 8, 2022, we completed a registered direct offering and concurrent private placement (together, the “September 2022 Offering”). In the registered direct offering, we issued 1,976,285 shares of common stock at a purchase price per share of $2.53, for aggregate gross proceeds to us of approximately $5.0 million, before deducting certain transaction expenses payable by us of approximately $0.7 million. The transaction expenses were net against the proceeds received and were included in additional paid-in capital.

 

10

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We issued to the investors in the September 2022 Offering warrants to purchase up to 3,359,684 shares of common stock (the “2022 Private Placement Warrants”). The 2022 Private Placement Warrants were immediately exercisable upon issuance at an exercise price of $2.40 per share and will expire on September 8, 2027.

 

In a concurrent private placement we issued pre-funded warrants (the “2022 Private Pre-Funded Warrants”) to purchase up to an aggregate of 1,383,399 shares of common stock at a purchase price of $2.5299 per share, for aggregate gross proceeds to us of approximately $3.5 million, before deducting transaction expenses payable by us, which were net against the proceeds received and were included in additional paid-in capital. The 2022 Private Pre-Funded Warrants were immediately exercisable at an exercise price of $0.0001 per share and will expire when the 2022 Private Pre-Funded Warrants are fully exercised.

 

During the six months ended June 30, 2023, 1,976,285 2022 Private Placement Warrants were exercised for $4,743,084 in proceeds, resulting in the issuance of 1,976,285 shares of common shares. As of June 30, 2023, there are 2022 Private Placement Warrants outstanding to purchase an aggregate of 1,383,399 shares of common stock. No 2022 Private Pre-Funded Warrants issued during the September 2022 Offering have been exercised as of June 30, 2023. Additionally, during the six months ended June 30, 2023, 302,150 of the 2021 Investor Warrants were exercised for $934,766 in proceeds, resulting in the issuance of 226,610 shares of common stock. As of June 30, 2023, there are 2021 Investor Warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock.

 

The September 2022 Offering resulted in aggregate gross proceeds of approximately $8.5 million before deducting transaction expenses. Net proceeds totaled approximately $7.8 million after deducting transaction costs of $0.7 million.

 

We obtained financing for certain Director & Officer liability insurance policy premiums from First Insurance Funding. The total premiums, taxes, and fees financed is $667,500 with an annual percentage interest rate of 8.735%. At June 30, 2023 the balance of insurance financing debt payable was $222,500, recorded at such date as short-term debt on the condensed consolidated balance sheet. The Company will pay the remaining insurance financing through the last quarterly installment payment on October 1, 2023.

 

Until such time as we can generate substantial product revenue, if ever, we expect to finance our cash needs through a combination of equity or debt financings and collaboration agreements. We do not currently have any committed external sources of capital.

 

To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders.

 

If we raise additional funds through collaboration agreements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.

 

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. 

 

Cash Flows

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities for the six months ended June 30, 2023, was approximately $13.3 million, consisting primarily of a net loss of $19.0 million, an increase of approximately $2.7 million in stock-based compensation expense, and a change in our operating assets and liabilities totaling $2.7 million. The decrease in net operating assets was primarily due to a decrease in accounts payable coupled with an increase in accrued expenses and other current liabilities and prepaid expenses and other current assets.

 

11

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Net cash used in operating activities for the six months ended June 30, 2022, was approximately $10.3 million, consisting primarily of a net loss of approximately $12.7 million, coupled with a change in our operating assets and liabilities totaling $2.6 million. The decrease in net operating assets was primarily due to increases in accounts payable, a decrease in prepaid expenses and other current assets and an increase in accrued expenses and other current liabilities.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities for the six months ended June 30, 2023 consists of approximately $0.7 million related to proceeds from the issuance of short-term debt and approximately $5.7 million related to proceeds from the exercise of warrants for common stock, slightly offset by repayments of short-term debt of approximately $0.4 million. Net cash provided by financing activities for the six months ended June 30, 2022, of $70 related to proceeds from the exercise of warrants for common stock.

 

Off-Balance Sheet Arrangements

 

We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

 

JOBS Act Accounting Election

 

As an emerging growth company under the Jumpstart Our Business Startups Act, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We have elected not to opt out of such extended transition period. Accordingly, when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, will adopt the new or revised standard at the time private companies adopt the new or revised standard, unless early adoption is permitted by the standard, and we elect early adoption. This may make comparison of our financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used. We expect that our eligibility to qualify as an emerging growth company will end on December 31, 2023, the last day of the fiscal year following the fifth anniversary of Tenzing’s initial public offering.

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As a smaller reporting company, we are not required to provide the information called for by this item.

 

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

12

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As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2023. Based on such evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30, 2023, our disclosure controls and procedures were effective at the reasonable assurance level. 

 

Changes in Internal Control Over Financial Reporting

 

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.  

 

Inherent Limitations on Effectiveness of Controls

 

Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

13

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PART II – Other Information

 

ITEM 1.

LEGAL PROCEEDINGS.

 

We may, from time to time, become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that may be, individually or in the aggregate, material to us.

 

ITEM 1A.

RISK FACTORS.

 

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.

 

There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023.

 

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

There were no unregistered sales of equity securities during the period covered by this report.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4.

MINE SAFETY DISCLOSURES.

 

Not applicable.

 

ITEM 5.

OTHER INFORMATION.

 

None.

 

14

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ITEM 6.

EXHIBITS.

 

Exhibit No.		Exhibit
31.1*		Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a)
31.2*		Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a)
32.1**		Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350
101.INS*		Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH*		Inline XBRL Taxonomy Extension Schema Document
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101)

 

*

Filed herewith.

 

**

The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act and will not be deemed to be incorporated by reference into any filing under such Act or the Securities Act of 1933, as amended, except to the extent that the registrant specifically incorporates such certifications by reference.

 

15

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

	Reviva Pharmaceuticals Holdings, Inc. (Registrant)
Date: August 14, 2023	/s/ Laxminarayan Bhat
	Laxminarayan Bhat
	Chief Executive Officer
	(Principal Executive Officer)
Date: August 14, 2023	/s/ Narayan Prabhu
	Narayan Prabhu
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

 

 

16

Exhibit 31.1

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER

Pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a),

As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Laxminarayan Bhat, hereby certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Reviva Pharmaceuticals Holdings, Inc.;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

Dated: August 14, 2023

	/s/ Laxminarayan Bhat
	Laxminarayan Bhat
	Chief Executive Officer
	(Principal Executive Officer)

 

 

 

Exhibit 31.2

CERTIFICATION OF THE CHIEF FINANCIAL OFFICER

Pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a),

As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Narayan Prabhu, hereby certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Reviva Pharmaceuticals Holdings, Inc.;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Dated: August 14, 2023

	/s/ Narayan Prabhu
	Narayan Prabhu
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

 

 

 

Exhibit 32.1

 

CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER

AND CHIEF FINANCIAL OFFICER

Pursuant To 18 U.S.C. Section 1350,

As Adopted Pursuant To Section 906 Of The Sarbanes-Oxley Act Of 2002

 

In connection with the Quarterly Report of Reviva Pharmaceuticals Holdings, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Quarterly Report”), Laxminarayan Bhat, as Chief Executive Officer of the Company, and Narayan Prabhu, Chief Financial Officer of the Company, each hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350), to his knowledge:

 

1

The Quarterly Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and

 

2

The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 14th day of August, 2023.

 

/s/ Laxminarayan Bhat		/s/ Narayan Prabhu
Laxminarayan Bhat		Narayan Prabhu
Chief Executive Officer		Chief Financial Officer
(Principal Executive Officer)		(Principal Financial and Accounting Officer)

 

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

 

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2023	Aug. 11, 2023
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-38634
Entity Registrant Name	Reviva Pharmaceuticals Holdings, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-4306526
Entity Address, Address Line One	19925 Stevens Creek Blvd., Suite 100
Entity Address, City or Town	Cupertino
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	95014
City Area Code	408
Local Phone Number	501-8881
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding (in shares)		22,650,266
Entity Central Index Key	0001742927
Current Fiscal Year End Date	--12-30
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	RVPH
Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants to purchase one share of Common Stock
Trading Symbol	RVPHW
Security Exchange Name	NASDAQ

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Assets [Abstract]
Cash and cash equivalents	$ 11,151,582	$ 18,519,856
Prepaid expenses and other current assets	690,440	403,819
Total Assets	11,842,022	18,923,675
Liabilities [Abstract]
Short-term debt	222,500	0
Accounts payable	2,648,287	3,520,271
Accrued expenses and other current liabilities	6,337,558	2,519,569
Total current liabilities	9,208,345	6,039,840
Warrant liabilities	1,012,490	567,439
Total Liabilities	10,220,835	6,607,279
Commitments and Contingencies
Equity [Abstract]
Common stock, par value of $0.0001; 115,000,000 shares authorized; 22,650,266 and 20,447,371 shares issued and outstanding as of June 30, 2023, and December 31, 2022, respectively	2,265	2,045
Additional paid-in capital	111,835,588	103,485,612
Accumulated deficit	(110,216,666)	(91,171,261)
Total stockholders' equity	1,621,187	12,316,396
Total Liabilities and Stockholders' Equity	$ 11,842,022	$ 18,923,675

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	115,000,000	115,000,000
Common Stock, Shares, Issued (in shares)	22,650,266	20,447,371
Common stock, shares outstanding (in shares)	22,650,266	20,447,371

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating expenses
Research and development	$ 8,991,250	$ 4,514,389	$ 14,226,249	$ 10,344,407
General and administrative	3,079,301	1,005,099	4,579,855	2,625,238
Total operating expenses	12,070,551	5,519,488	18,806,104	12,969,645
Loss from operations	(12,070,551)	(5,519,488)	(18,806,104)	(12,969,645)
Other income (expense)
Gain on remeasurement of warrant liabilities	(456,177)	178,021	(445,051)	267,031
Interest expense	(12,759)	0	(20,414)	0
Interest income	103,080	13,825	250,091	15,560
Other expense	(19)	(6,141)	(14,513)	(8,108)
Total other (expense) income, net	(365,875)	185,705	(229,887)	274,483
Loss before provision for income taxes	(12,436,426)	(5,333,783)	(19,035,991)	(12,695,162)
Provision for income taxes	6,436	6,921	9,414	10,550
Net loss	$ (12,442,862)	$ (5,340,704)	$ (19,045,405)	$ (12,705,712)
Earnings Per Share [Abstract]
Basic and diluted (in dollars per share)	$ (0.55)	$ (0.29)	$ (0.86)	$ (0.69)
Earnings Per Share, Basic, Other Disclosure [Abstract]
Basic and diluted (in shares)	22,434,781	18,466,586	22,135,850	18,466,586

Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance (in shares) at Dec. 31, 2021	14,433,286
Balance at Dec. 31, 2021	$ 1,443	$ 95,516,986	$ (66,831,969)	$ 28,686,460
Common stock issued in connection with warrant exercises (in shares)	700,000
Common stock issued in connection with warrant exercises	$ 70	0	0	70
Stock-based compensation expense	0	79,562	0	79,562
Net loss	$ 0	0	(12,705,712)	(12,705,712)
Balance (in shares) at Jun. 30, 2022	15,133,286
Balance at Jun. 30, 2022	$ 1,513	95,596,548	(79,537,681)	16,060,380
Balance (in shares) at Dec. 31, 2021	14,433,286
Balance at Dec. 31, 2021	$ 1,443	95,516,986	(66,831,969)	28,686,460
Balance (in shares) at Dec. 31, 2022	20,447,371
Balance at Dec. 31, 2022	$ 2,045	103,485,612	(91,171,261)	12,316,396
Balance (in shares) at Mar. 31, 2022	15,133,286
Balance at Mar. 31, 2022	$ 1,513	95,556,672	(74,196,977)	21,361,208
Stock-based compensation expense	0	39,876	0	39,876
Net loss	$ 0	0	(5,340,704)	(5,340,704)
Balance (in shares) at Jun. 30, 2022	15,133,286
Balance at Jun. 30, 2022	$ 1,513	95,596,548	(79,537,681)	16,060,380
Balance (in shares) at Dec. 31, 2022	20,447,371
Balance at Dec. 31, 2022	$ 2,045	103,485,612	(91,171,261)	12,316,396
Common stock issued in connection with warrant exercises (in shares)	2,202,895
Common stock issued in connection with warrant exercises	$ 220	5,677,630	0	5,677,850
Stock-based compensation expense	0	2,672,346	0	2,672,346
Net loss	$ 0	0	(19,045,405)	(19,045,405)
Balance (in shares) at Jun. 30, 2023	22,650,266
Balance at Jun. 30, 2023	$ 2,265	111,835,588	(110,216,666)	1,621,187
Balance (in shares) at Mar. 31, 2023	20,452,121
Balance at Mar. 31, 2023	$ 2,045	103,556,732	(97,773,804)	5,784,973
Common stock issued in connection with warrant exercises (in shares)	2,198,145
Common stock issued in connection with warrant exercises	$ 220	5,658,037	0	5,658,257
Stock-based compensation expense	0	2,620,819	0	2,620,819
Net loss	$ 0	0	(12,442,862)	(12,442,862)
Balance (in shares) at Jun. 30, 2023	22,650,266
Balance at Jun. 30, 2023	$ 2,265	$ 111,835,588	$ (110,216,666)	$ 1,621,187

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Net Cash Provided by (Used in) Operating Activities [Abstract]
Net loss	$ (12,442,862)	$ (5,340,704)	$ (19,045,405)	$ (12,705,712)
Adjustments to reconcile net loss to net cash used in operating activities
Change in fair value of warrant liabilities			445,051	(267,031)
Stock-based compensation expense			2,672,346	79,562
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			(286,621)	661,972
Accounts payable			(871,984)	1,874,328
Accrued expenses and other current liabilities			3,817,989	88,929
Net cash used in operating activities			(13,268,624)	(10,267,952)
Cash flows from financing activities
Proceeds from issuance of short-term debt			667,500	0
Repayment of short-term debt			(445,000)	0
Proceeds from exercise of warrants			5,677,850	70
Net cash provided by financing activities			5,900,350	70
Net decrease in cash and cash equivalents			(7,368,274)	(10,267,882)
Cash and cash equivalents, beginning of period			18,519,856	29,687,944	$ 29,687,944
Cash and cash equivalents, end of period	11,151,582	19,420,062	11,151,582	19,420,062	$ 18,519,856
Supplemental disclosures of cash flow information:
Cash paid for taxes			3,941	3,981
Interest Paid, Excluding Capitalized Interest, Operating Activities			20,414	0
Prepaid expenses included in accounts payable	$ 0	$ 169,314	$ 0	$ 169,314

Note 1 - Organization and Nature of Operations	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]	1.   ORGANIZATION AND NATURE OF OPERATIONS   On December 14, 2020, Reviva Pharmaceuticals Holdings, Inc. (the “Company”), a Delaware corporation and the successor by re-domiciliation to Tenzing Acquisition Corp. (“Tenzing”), a British Virgin Islands exempted company, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiary), consummated a business combination (the “Business Combination”) through the merger of Merger Sub with and into Reviva Pharmaceuticals, Inc. (the “Merger”), in accordance with the Agreement and Plan of Merger, dated as of July 20, 2020 (the “Merger Agreement”), by and among Tenzing, Merger Sub, Reviva Pharmaceuticals, Inc., and the other parties thereto. Pursuant to the Merger Agreement, at the effective time of the Merger, Merger Sub merged with and into Reviva Pharmaceuticals, Inc., with Reviva Pharmaceuticals, Inc. as the surviving company in the Merger and, after giving effect to such Merger, Reviva Pharmaceuticals, Inc. becoming a wholly-owned subsidiary of Reviva Pharmaceuticals Holdings, Inc. In these notes to the condensed consolidated financial statements, unless otherwise specified or the context indicates otherwise, references to the “Company,” “Reviva,” “we,” “us” and “our” refer to Reviva Pharmaceuticals Holdings, Inc. and its consolidated subsidiaries.   Reviva Pharmaceuticals, Inc. was originally incorporated in the state of Delaware and commenced operations on May 1, 2006 and its Indian subsidiary, Reviva Pharmaceuticals India Pvt. Ltd. was incorporated in 2014. The Company is a late-stage pharmaceutical company developing new therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases.

Note 2 - Summary of Significant Accounting Policies and Basis of Presentation	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Significant Accounting Policies [Text Block]	2.   SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION   Basis of Presentation   The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2023.   The condensed consolidated balance sheet as of December 31, 2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2023.   Liquidity and Going Concern   The Company has incurred losses since inception and as of June 30, 2023, the Company had working capital of approximately $2.6 million, an accumulated deficit of $110.2 million and cash and cash equivalents on hand of approximately $11.2 million. The Company’s net loss for the three months ended June 30, 2023 and 2022, was approximately $12.4 million and $5.3 million, respectively. The Company's net loss for the six months ended June 30, 2023 and 2022, was approximately $19.0 million and $12.7 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so.     The Company obtained financing for certain Director & Officer liability insurance policy premiums from First Insurance Funding (the “Lender”). The total premiums, taxes, and fees financed is $667,500 with an annual percentage interest rate of 8.735%. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on the condensed consolidated balance sheet, with the last quarterly installment payment due on October 1, 2023.   The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern.   Use of estimates   The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, depreciative and amortization useful lives, assumptions used to calculate the fair value of stock-based compensation, warrant values, deferred taxes, and related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances.   Concentration of credit risk and other risks and uncertainties   Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. Currently, substantially all the Company’s cash and cash equivalents are held in demand deposit form at two financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash.   The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of products in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors.   Impact of COVID-19   In response to the spread of COVID-19, the Company has taken temporary precautionary measures intended to help minimize the risk of the virus to its employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for the Company’s employees.   As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, the Company may experience disruptions that could adversely impact the Company’s business. Effects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. Effects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that the Company intends to rely upon to assist it in conducting its clinical trials and the contract manufacturers who manufacture the Company’s drug candidates.     The Company is continuing to assess the potential impact of the continuing and lasting effects of the COVID-19 pandemic on its business and operations as of June 30, 2023.

Note 3 - Employee Benefit Plan	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Compensation and Employee Benefit Plans [Text Block]	3. EMPLOYEE BENEFIT PLAN   In 2014, Reviva Pharmaceuticals, Inc. implemented a tax deferred savings plan, commonly referred to as a 401(k) plan. Employee’s contributions are withheld from standard payroll checks and are automatically withdrawn from the Company checking account and deposited into individual employee retirement accounts a few days following each payroll period. Employees can defer or contribute the statutory legal limits. There has been no Company matching of employee contributions to the plan through June 30, 2023.

Note 4 - Loss Per Share	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Earnings Per Share [Text Block]	4.   LOSS PER SHARE   Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share includes potentially dilutive securities such as stock options, warrants to purchase common stock, and other convertible instruments unless the result of inclusion would be anti-dilutive. These securities have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022, because all such securities are anti-dilutive for all periods presented.   The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:       Three Months Ended June 30,     Six Months Ended June 30,       2023     2022     2023     2022   Shares issuable upon exercise of stock options     1,547,774       192,898       1,547,774       192,898   Shares issuable upon exercise of warrants to purchase common stock     15,030,209       13,883,732       15,030,209       13,883,732   Shares contingently issuable for earnout     1,000,000       1,000,000       1,000,000       1,000,000         17,577,983       15,076,630       17,577,983       15,076,630     The diluted loss per share computation equals basic loss per share for the three and six months ended June 30, 2023 and 2022 because the Company had a net loss and the impact of the assumed exercise of stock options and warrants would have been anti-dilutive.

Note 5 - Warrants	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Warrants [Text Block]	5.   WARRANTS   As of June 30, 2023, there were public warrants outstanding to purchase an aggregate of 6,325,000 shares of common stock, private warrants outstanding to purchase an aggregate of 1,939,712 shares of common stock, investor warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock, private pre-funded warrants to purchase an aggregate of 1,383,399 shares of common stock, and assumed warrants outstanding to purchase an aggregate of 120,456 shares of common stock.   2020 Business Combination   In connection with the closing of our Business Combination in 2020, our predecessor company, Tenzing, issued public warrants to purchase 6,325,000 shares and private placement warrants to purchase 556,313 shares.     Further, there were assumed warrants to purchase an aggregate of 126,268 shares of common stock, of which 5,812 expired during fiscal year 2022. These warrants were classified as equity as of June 30, 2023 and June 30, 2022. The fair value of these warrants on the date of issuance was $1,279,182.   Each public warrant entitles the holder thereof to purchase one share of common stock at a price of $11.50 per share, subject to adjustment. No public warrants will be exercisable for cash unless we have an effective and current registration statement covering the issuance of the shares of common stock issuable upon exercise of the public warrants and a current prospectus relating to such shares of common stock.   We may call the public warrants for redemption, in whole and not in part, at a price of $0.01 per warrant;     • if, and only if, the reported last sale price of the common stock equals or exceeds $21.00 per share (as adjusted for stock splits, stock dividends, reorganizations and recapitalizations), for any 20 trading days within a 30 trading day period ending on the third trading business day prior to the notice of redemption to holders of the public warrants, and     • if, and only if, there is a current registration statement in effect with respect to the issuance of the shares of common stock underlying such Public Warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption     • at any time while the public warrants are exercisable     • upon not less than 30 days’ prior written notice of redemption to each warrant holder   The private warrants are substantially similar to the public warrants except such private warrants;     • are exercisable for cash or on a cashless basis, at the holder’s option     • cannot be redeemed by us, so long as they are still held by the initial purchasers or their affiliates.     • The redemption price is to be calculated as the 10-day average trading price ending one trading business day prior to the notice of redemption.   In no event will the Company be required to net cash settle either the public or the private warrants.   The exercise price and number of shares of common stock issuable on exercise of the warrants may be adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or a recapitalization, reorganization, merger or consolidation. The private warrants were classified as derivative liabilities pursuant to ASC 815 (see to Note 9).   2021 Public Offering   In connection with the Company’s public offering of units completed on June 1, 2021, the Company issued pre-funded warrants (“2021 Pre-Funded Warrants”) exercisable for 5,066,600 shares of common stock and warrants (“2021 Investor Warrants”) exercisable for 6,900,000 shares of common stock.   During fiscal year 2021, 1,033,300 of the 2021 Pre-Funded Warrants were exercised for $103 in proceeds, resulting in the issuance of 1,033,300 common shares. During fiscal year 2022, 4,033,300 of the 2021 Pre-Funded Warrants were exercised for $403 in proceeds, resulting in the issuance of 4,033,300 common shares. There were no 2021 Pre-Funded Warrants outstanding as of June 30, 2023.   During fiscal year 2022, 6,000 of the 2021 Investor Warrants were exercised for $18,563 in proceeds, resulting in the issuance of 4,500 shares of common stock. During the three months ended June 30, 2023, 295,816 of the 2021 Investor Warrants were exercised for $915,173 in proceeds, resulting in the issuance of 221,860 shares of common stock. During the six months ended June 30, 2023, 302,150 of the 2021 Investor Warrants were exercised for $934,766 in proceeds, resulting in the issuance of 226,610 shares of common stock. As of June 30, 2023, there are 2021 Investor Warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock.     2022 Registered Direct Offering and Private Placement   On September 8, 2022, the Company completed a registered direct offering and concurrent private placement (the “September 2022 Offering”). In connection with this offering, the Company issued to investors warrants (the “2022 Private Placement Warrants”) to purchase up to 3,359,684 shares of common stock. The 2022 Private Placement Warrants were immediately exercisable upon issuance.   In a concurrent private placement, the Company issued pre-funded warrants (the “2022 Private Pre-Funded Warrants”) to purchase up to an aggregate of 1,383,399 shares of common stock. The 2022 Private Pre-Funded Warrants were immediately exercisable.   During the three and six months ended June 30, 2023, an aggregate of 1,976,285 of the 2022 Private Placement Warrants were exercised for $4,743,084 in proceeds, resulting in the issuance of 1,976,285 shares of common stock. As of June 30, 2023, there are 1,383,399 of the 2022 Private Placement Warrants outstanding to purchase an aggregate of 1,383,399 shares of common stock. No 2022 Private Pre-Funded Warrants issued during the September 2022 Offering have been exercised as of June 30, 2023.   The Company has determined that as the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants were issued at fair value in an offering transaction in tandem with shares of equity with no debt funding included in the offering, the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants should be classified as equity.   The fair value of the 2022 Private Placement Warrants and 2022 Private Pre-Funded Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., Company share price of $2.20, exercise price of $2.40 for the 2022 Private Placement Warrants and $0.0001 for the 2022 Private Pre-Funded Warrants, term of 5 years, volatility of 111%, risk-free rate of 3.4%, and expected dividend rate of 0%). The grant date relative fair value of these warrants was estimated to be $5,712,592 on September 8, 2022 and are classified as equity.   The Company evaluated the 2022 Private Placement Warrants and the 2022 Private Pre-Funded Warrants in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging, and determined that they should be classified as equity instruments, with no recurring fair value measurement required. The warrants are indexed to the Company’s common stock and are required to be settled through physical settlement or net share settlement, if exercised. Accordingly, the warrants were recorded at their grant date fair value with no subsequent remeasurement.

Note 6 - Stock-based Compensation	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Share-Based Payment Arrangement [Text Block]	6.  STOCK-BASED COMPENSATION   Stock-Based Compensation Expense   On April 25, 2023, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) approved the grant of option awards to certain of the Company's officers and employees in accordance with the terms of the Company’s 2020 Equity Incentive Plan ("2020 Plan"). The Compensation Committee's approval included options granted to purchase a total of 1,303,000 shares of common stock to the Company's executive officers and other employees of the Company. All of the options were granted pursuant to the 2020 Plan and have an exercise price of $6.74 per share, based on the closing price of the common stock on the grant date in accordance with the terms of the 2020 Plan. The options granted to the named executive officers and Vice President for Program & Portfolio Management were immediately vested as to 50% of the shares subject thereto on the grant date, and will vest as to an additional 1.389% of the shares subject thereto on the last day of each month thereafter and have a ten-year expiration date. The options granted to the other employees have varying vesting terms between three and four years.     The Company records stock-based compensation expense in connection with the amortization of the fair value of stock options granted to employees, non-employee consultants and non-employee directors. During the three months ended June 30, 2023 and 2022, the Company recorded stock-based compensation of $2,620,819 and $39,876 respectively. During the six months ended June 30, 2023 and 2022, the Company recorded stock-based compensation of $2,672,346 and $79,562 respectively. As of June 30, 2023, the Company had unrecognized stock-based compensation expense of $4,188,195, which is expected to be recognized over a weighted-average period of 3.0 years. As of June 30, 2023, there are 0 and 1,297,063 shares of common stock available for issuance under the 2006 Equity Incentive Plan and the 2020 Plan, respectively.   Determining Fair Value   Valuation and Recognition – The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes pricing model utilizes the following assumptions:   Expected Term – Expected life of an option award is the average length of time over which the Company expects employees will exercise their options, which is based on historical experience with similar grants.   Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the awards.   Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent expected term.   Dividend Yield – The Company has not paid a dividend and does not anticipate paying a dividend in the foreseeable future.   There were no options granted during the six months ended June 30, 2022. The value of option grants is calculated using the Black-Scholes option pricing model with the following assumptions for options granted during the six months ended June 30, 2023:       June 30, 2023   Risk-free interest rate     3.43%     Expected term (in years)   5.37 - 6.05   Expected volatility   86.64% - 88.56%   Expected dividend yield     0%       Activity under the stock plans for the six months ended June 30, 2023, is as follows:       Shares Available for Grant     Number of Options Outstanding     Weighted Average Exercise price per share     Weighted Average Remaining Contractual Term in Years     Aggregate Intrinsic Value   Balance, December 31, 2022     2,600,063       244,774     $ 6.32       8.62     $ —   Granted     (1,303,000 )     1,303,000     $ 6.74                   Balance, June 30, 2023     1,297,063       1,547,774     $ 6.67       9.55     $ 314,468                                             Options exercisable at June 30, 2023             622,027     $ 6.96       9.32     $ 188,850     The options granted had a $4.90 weighted average grant date fair value during the six months ended June 30, 2023.

Note 7 - Short-term Debt	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Short-Term Debt [Text Block]	7.   SHORT-TERM DEBT   Insurance Funding   The Company obtained financing for certain Director & Officer liability insurance policy premiums. The governing agreement assigns the Lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies.   The total premiums, taxes and fees financed is $667,500 with an annual interest rate of 8.735%. In consideration of the premium payment by the Lender to the insurance companies or the agent or broker, the Company unconditionally promises to pay the Lender the amount financed plus interest and other charges permitted under the governing agreement. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on its condensed consolidated balance sheet. The Company will pay the remaining insurance financing through the last quarterly installment payment on October 1, 2023.

Note 8 - Commitments and Contingencies	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	8.   COMMITMENTS AND CONTINGENCIES   Clinical trials   Since 2010, the Company has entered into multiple clinical trial agreements with medical institutions in the United States, Europe and Asia for the purpose of enrolling patients into various clinical trials. The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, the amount to be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions. The clinical trial services provided by each site generally include the screening of prospective patients and, for those patients to be enrolled in the study, administration of the Company’s investigation drug according to the trial protocol, any required hospitalization, ancillary medical supplies, and 2-week patient follow-up. Further, each agreement requires the Company to indemnify each respective clinical site against any and all liability, loss, or damage it may suffer as a result of third-party claims; the Company maintains product liability insurance of not less than $10 million in conjunction with this indemnification. The agreements may be terminated upon 30 days’ written notice, subject to conditions of paying all liabilities incurred through the date of termination. Additionally, with each screened patient, the Company incurs expense with other entities engaged to provide independent review of patient medical records.   As part of the Company's agreement with one of its clinical research organizations, the Company is required to maintain a 7% upfront float for fees related to expenses incurred in clinical studies. When the float has depleted to 15% (i.e. 85% of the float has been used) the Company will receive an invoice to replenish the float up to 7% of the remaining estimated budget for the studies. During the three months ended June 30, 2023, the Company did not make any additional payments to replenish the float and expensed approximately $0.7 million. During the six months ended June 30, 2023, the Company paid approximately $0.9 million to replenish the float and expensed approximately $1.0 million. As of June 30, 2023, the Company has no remaining prepaid float balance.   Indemnification   From time to time, in its normal course of business, the Company may indemnify other parties, with whom it enters into contractual relationships, including lessors and parties to other transactions with the Company. The Company may agree to hold other parties harmless against specific losses, such as those that could arise from a breach of representation, covenant or third-party infringement claims. It may not be possible to determine the maximum potential amount of liability under such indemnification obligations due to the unique facts and circumstances that are likely to be involved in each particular claim and indemnification provision. Historically, there have been no such indemnification claims. The Company has also indemnified its directors and executive officers, to the extent legally permissible, against all liabilities reasonably incurred in connection with any action in which such individual may be involved by reason of such individual being or having been a director or executive officer.     Operating Leases   The Company adopted ASC 842, Leases, on January 1, 2019. The Company has elected to apply the short-term lease exception to leases of one year or less. Presently, the Company has a single twelve-month lease on its Corporate Office located at 19925 Stevens Creek Blvd., Suite 100, Cupertino, CA 95014. The monthly lease payment is approximately $1,447 and the lease was renewed in February 2022 and again on February 1, 2023, for another 12-month term.

Note 9 - Fair Value Measurements	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Fair Value Disclosures [Text Block]	9. FAIR VALUE MEASUREMENTS   Fair value is defined as 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. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:     • Level 1 — Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.     • Level 2 — Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.     • Level 3 — Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.   The determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant to the fair value measurement.   The following is a listing of the Company’s warrant liabilities required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of June 30, 2023 and December 31, 2022:       June 30, 2023       Level 1     Level 2     Level 3     Total       (unaudited)   Liabilities:                                 Warrant liability     —       —     $ 1,012,490     $ 1,012,490   Total   $ —     $ —     $ 1,012,490     $ 1,012,490         December 31, 2022       Level 1     Level 2     Level 3     Total   Liabilities:                                 Warrant liability   $ —     $ —     $ 567,439     $ 567,439   Total   $ —     $ —     $ 567,439     $ 567,439       The following table summarizes the changes in the fair value of the warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3):       Three Months Ended June 30,     Six Months Ended June 30,       2023     2022     2023     2022       (unaudited)     (unaudited)   Balance, beginning of period   $ 556,313       283,720       567,439     $ 372,730   Change in fair value of warrant liability     456,177       (178,021 )     445,051       (267,031 ) Balance, end of period   $ 1,012,490     $ 105,699     $ 1,012,490     $ 105,699     The Company classified the private warrants pursuant to ASC 815 as derivative liabilities, as the warrants have terms which are modified upon any future transfer of ownership, with subsequent changes in their fair values to be recognized in the consolidated financial statements at each reporting date. The Company calculated the fair value of the private warrants as of June 30, 2023 as $1,012,490 using a Black-Scholes model. The key inputs used in the Black-Scholes calculation were the risk-free interest rate, expected volatility, expected life, exercise price and stock price. The risk-free interest rate was estimated to be 4.70%, the expected volatility was estimated to be 77.90%, and the expected life was estimated to be 2.46 years. The exercise price was $11.50, and the stock price $5.86.   The Company recorded a loss on remeasurement of warrant liabilities of $456,177 and a gain of 178,021 for the three months ended June 30, 2023 and 2022, respectively. The Company recorded a loss on remeasurement of warrant liabilities of $445,051 and a gain of $267,031 for the six months ended June 30, 2023 and 2022, respectively.

Note 10 - Subsequent Events	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Subsequent Events [Text Block]

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Basis of Accounting, Policy [Policy Text Block]	Basis of Presentation   The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2023.   The condensed consolidated balance sheet as of December 31, 2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2023.
Going Concern [Policy Text Block]	Liquidity and Going Concern   The Company has incurred losses since inception and as of June 30, 2023, the Company had working capital of approximately $2.6 million, an accumulated deficit of $110.2 million and cash and cash equivalents on hand of approximately $11.2 million. The Company’s net loss for the three months ended June 30, 2023 and 2022, was approximately $12.4 million and $5.3 million, respectively. The Company's net loss for the six months ended June 30, 2023 and 2022, was approximately $19.0 million and $12.7 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so.     The Company obtained financing for certain Director & Officer liability insurance policy premiums from First Insurance Funding (the “Lender”). The total premiums, taxes, and fees financed is $667,500 with an annual percentage interest rate of 8.735%. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on the condensed consolidated balance sheet, with the last quarterly installment payment due on October 1, 2023.   The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern.
Use of Estimates, Policy [Policy Text Block]	Use of estimates   The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, depreciative and amortization useful lives, assumptions used to calculate the fair value of stock-based compensation, warrant values, deferred taxes, and related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances.
Concentration Risk, Credit Risk, Policy [Policy Text Block]	Concentration of credit risk and other risks and uncertainties   Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. Currently, substantially all the Company’s cash and cash equivalents are held in demand deposit form at two financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash.   The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of products in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors.
Impact of COVID-19 [Policy Text Block]	Impact of COVID-19   In response to the spread of COVID-19, the Company has taken temporary precautionary measures intended to help minimize the risk of the virus to its employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for the Company’s employees.   As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, the Company may experience disruptions that could adversely impact the Company’s business. Effects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. Effects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that the Company intends to rely upon to assist it in conducting its clinical trials and the contract manufacturers who manufacture the Company’s drug candidates.     The Company is continuing to assess the potential impact of the continuing and lasting effects of the COVID-19 pandemic on its business and operations as of June 30, 2023.

Note 4 - Loss Per Share (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	Three Months Ended June 30,     Six Months Ended June 30,       2023     2022     2023     2022   Shares issuable upon exercise of stock options     1,547,774       192,898       1,547,774       192,898   Shares issuable upon exercise of warrants to purchase common stock     15,030,209       13,883,732       15,030,209       13,883,732   Shares contingently issuable for earnout     1,000,000       1,000,000       1,000,000       1,000,000         17,577,983       15,076,630       17,577,983       15,076,630

Note 6 - Stock-based Compensation (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]	June 30, 2023   Risk-free interest rate     3.43%     Expected term (in years)   5.37 - 6.05   Expected volatility   86.64% - 88.56%   Expected dividend yield     0%
Share-Based Payment Arrangement, Option, Activity [Table Text Block]	Shares Available for Grant     Number of Options Outstanding     Weighted Average Exercise price per share     Weighted Average Remaining Contractual Term in Years     Aggregate Intrinsic Value   Balance, December 31, 2022     2,600,063       244,774     $ 6.32       8.62     $ —   Granted     (1,303,000 )     1,303,000     $ 6.74                   Balance, June 30, 2023     1,297,063       1,547,774     $ 6.67       9.55     $ 314,468                                             Options exercisable at June 30, 2023             622,027     $ 6.96       9.32     $ 188,850

Note 9 - Fair Value Measurements (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Fair Value, Assets Measured on Recurring Basis [Table Text Block]	June 30, 2023       Level 1     Level 2     Level 3     Total       (unaudited)   Liabilities:                                 Warrant liability     —       —     $ 1,012,490     $ 1,012,490   Total   $ —     $ —     $ 1,012,490     $ 1,012,490       December 31, 2022       Level 1     Level 2     Level 3     Total   Liabilities:                                 Warrant liability   $ —     $ —     $ 567,439     $ 567,439   Total   $ —     $ —     $ 567,439     $ 567,439
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]	Three Months Ended June 30,     Six Months Ended June 30,       2023     2022     2023     2022       (unaudited)     (unaudited)   Balance, beginning of period   $ 556,313       283,720       567,439     $ 372,730   Change in fair value of warrant liability     456,177       (178,021 )     445,051       (267,031 ) Balance, end of period   $ 1,012,490     $ 105,699     $ 1,012,490     $ 105,699

Note 2 - Summary of Significant Accounting Policies and Basis of Presentation (Details Textual) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Working Capital	$ 2,600,000		$ 2,600,000
Retained Earnings (Accumulated Deficit), Total	110,216,666		110,216,666		$ 91,171,261
Cash	11,200,000		11,200,000
Net Income (Loss) Attributable to Parent, Total	(12,442,862)	$ (5,340,704)	(19,045,405)	$ (12,705,712)
Net Income (Loss) Attributable to Parent	12,442,862	$ 5,340,704	19,045,405	12,705,712
Repayments of Short-Term Debt			445,000	$ (0)
Short-Term Debt	222,500		222,500		$ 0
Financing for Liability Insurance Policy Premiums [Member]
Debt Instrument, Face Amount	667,500		667,500
Repayments of Short-Term Debt			445,000
Short-Term Debt	$ 222,500		$ 222,500

Note 4 - Loss Per Share - Antidilutive Securities (Details) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Antidilutive securities (in shares)	17,577,983	15,076,630	17,577,983	15,076,630
Share-Based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)	1,547,774	192,898	1,547,774	192,898
Warrant [Member]
Antidilutive securities (in shares)	15,030,209	13,883,732	15,030,209	13,883,732
Earn-out Shares [Member]
Antidilutive securities (in shares)	1,000,000	1,000,000	1,000,000	1,000,000

Note 5 - Warrants (Details Textual)	3 Months Ended	6 Months Ended		12 Months Ended
	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) $ / shares shares	Jun. 30, 2022 USD ($)	Dec. 31, 2022 USD ($) shares	Dec. 31, 2021 USD ($) shares	Sep. 08, 2022 USD ($) $ / shares shares	Jun. 01, 2021 shares	Dec. 31, 2020 USD ($) shares
Proceeds from Warrant Exercises | $		$ 5,677,850	$ 70
Share Price | $ / shares						$ 2.20
Public Warrants [Member]
Class of Warrant or Right, Outstanding	6,325,000	6,325,000
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right	1	1						6,325,000
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares	$ 11.50	$ 11.50
Class of Warrant or Right, Redemption Price Per Share | $ / shares	0.01	0.01
Threshold Closing Price for Specified Number of Trading Days | $ / shares	$ 21.00	$ 21.00
Threshold Trading Days for Sale of Shares (Day)		20 days
Threshold Consecutive Trading Days for Sale of Shares (Day)		30 days
Private Warrants [Member]
Class of Warrant or Right, Outstanding	1,939,712	1,939,712
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares	$ 11.50	$ 11.50
Share Price | $ / shares	$ 5.86	$ 5.86
Private Warrants [Member] | Measurement Input, Price Volatility [Member]
Warrants and Rights Outstanding, Measurement Input	0.7790	0.7790
Private Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants and Rights Outstanding, Measurement Input	0.0470	0.0470
Investor Warrant [Member]
Class of Warrant or Right, Outstanding	6,645,041	6,645,041
Class of Warrant or Right, Number of Securities Called by Warrants or Rights							6,900,000
Class of Warrant or Right, Exercised During Period (in shares)	295,816	302,150		6,000
Proceeds from Warrant Exercises | $	$ 915,173	$ 934,766		$ 18,563
Stock Issued During Period, Shares, Warrants Exercised (in shares)	221,860	226,610		4,500
Private Pre-funded Warrant [Member]
Class of Warrant or Right, Outstanding	1,383,399	1,383,399
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right						1,383,399
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares						$ 0.0001
Assumed Warrants [Member]
Class of Warrant or Right, Outstanding	120,456	120,456
Class of Warrant or Right, Number of Securities Called by Warrants or Rights								126,268
Class of Warrant or Right, Expired During Period				5,812
Warrants and Rights Outstanding | $								$ 1,279,182
Private Placement Warrants [Member]
Class of Warrant or Right, Outstanding	1,383,399	1,383,399
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	1,383,399	1,383,399				3,359,684		556,313
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares						$ 2.40
Class of Warrant or Right, Exercised During Period (in shares)	1,976,285
Proceeds from Warrant Exercises | $	$ 4,743,084
Stock Issued During Period, Shares, Warrants Exercised (in shares)	1,976,285
Pre-Funded Warrant [Member]
Class of Warrant or Right, Outstanding	0	0
Class of Warrant or Right, Number of Securities Called by Warrants or Rights							5,066,600
Class of Warrant or Right, Exercised During Period (in shares)				4,033,300	1,033,300
Proceeds from Warrant Exercises | $				$ 403	$ 103
Stock Issued During Period, Shares, Warrants Exercised (in shares)				4,033,300	1,033,300
Private Placement Warrants and Private Pre-funded Warrants [Member]
Warrants and Rights Outstanding | $						$ 5,712,592
Warrants and Rights Outstanding, Term						5 years
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Price Volatility [Member]
Warrants and Rights Outstanding, Measurement Input						1.11
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants and Rights Outstanding, Measurement Input						0.034
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]
Warrants and Rights Outstanding, Measurement Input						0

Note 6 - Stock-based Compensation (Details Textual) - USD ($)		3 Months Ended		6 Months Ended
	Apr. 25, 2023	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross	1,303,000
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price	$ 6.74
Share-Based Payment Arrangement, Expense		$ 2,620,819	$ 39,876	$ 2,672,346	$ 79,562
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount		$ 4,188,195		$ 4,188,195
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition				3 years
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value				$ 4.90
Equity Incentive Plan 2006 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized		0		0
Equity Incentive Plan 2020 [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized		1,297,063		1,297,063
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross				1,303,000
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price				$ 6.74
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period	10 years
Share-Based Payment Arrangement, Option [Member] | Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period	3 years
Share-Based Payment Arrangement, Option [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period	4 years
Share-Based Payment Arrangement, Option [Member] | Vesting Immediately [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage	50.00%
Share-Based Payment Arrangement, Option [Member] | Vest at the End of Each Month [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage	1.389%

Note 6 - Stock-based Compensation - Schedule of Valuation Assumptions (Details)	6 Months Ended
	Jun. 30, 2023
Risk-free interest rate	3.43%
Expected dividend yield	0.00%
Minimum [Member]
Expected term (in years) (Year)	5 years 4 months 13 days
Expected volatility	86.64%
Maximum [Member]
Expected term (in years) (Year)	6 years 18 days
Expected volatility	88.56%

Note 6 - Stock-based Compensation - Stock Option Activity (Details) - USD ($)		6 Months Ended	12 Months Ended
	Apr. 25, 2023	Jun. 30, 2023	Dec. 31, 2022
Granted, number of options outstanding (in shares)	1,303,000
Granted, weighted average exercise price (in dollars per share)	$ 6.74
Share-Based Payment Arrangement, Option [Member]
Balance, shares available for grant (in shares)			2,600,063
Balance, option outstanding (in shares)			244,774
Balance, weighted average exercise price (in dollars per share)			$ 6.32
Balance, weighted average remaining contractual term (Year)		9 years 6 months 18 days	8 years 7 months 13 days
Balance, aggregate intrinsic value		$ 314,468	$ 0
Granted (in shares)		(1,303,000)
Granted, number of options outstanding (in shares)		1,303,000
Granted, weighted average exercise price (in dollars per share)		$ 6.74
Balance, shares available for grant (in shares)		1,297,063
Balance, option outstanding (in shares)		1,547,774
Balance, weighted average exercise price (in dollars per share)		$ 6.67
Options exercisable (in shares)		622,027
Options exercisable, weighted average exercise price (in dollars per share)		$ 6.96
Options exercisable, weighted average remaining contractual term (Year)		9 years 3 months 25 days
Options exercisable, aggregate intrinsic value		$ 188,850

Note 7 - Short-term Debt (Details Textual) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Repayments of Short-Term Debt	$ 445,000	$ (0)
Short-Term Debt	222,500		$ 0
Financing for Liability Insurance Policy Premiums [Member]
Debt Instrument, Face Amount	$ 667,500
Debt Instrument, Interest Rate, Stated Percentage	8.735%
Repayments of Short-Term Debt	$ 445,000
Short-Term Debt	$ 222,500

Note 8 - Commitments and Contingencies (Details Textual)	3 Months Ended	6 Months Ended
	Jun. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)
Corporate Office Lease [Member]
Lessee, Operating Lease, Term of Contract	12 months	12 months
Lessee, Operating Lease, Monthly Lease Payment		$ 1,447
Agreement With One of Clinical Research Organizations [Member]
Agreement, Required Upfront Float for Fees, Percentage	7.00%	7.00%
Agreement, Upfront Float, Percentage Left to Receive Invoice to Replenish	15.00%	15.00%
Agreement, Upfront Float, Percentage Used to Receive Invoice to Replenish	85.00%	85.00%
Payments for Upfront Float	$ 700,000	$ 900,000
Prepaid Float Expense		1,000,000.0
Minimum [Member]
General Product Liability Insurance	$ 10,000,000	$ 10,000,000

Note 9 - Fair Value Measurements (Details Textual)	3 Months Ended		6 Months Ended
	Jun. 30, 2023 USD ($) $ / shares	Jun. 30, 2022 USD ($)	Jun. 30, 2023 USD ($) $ / shares	Jun. 30, 2022 USD ($)	Sep. 08, 2022 $ / shares
Share Price | $ / shares					$ 2.20
Fair Value Adjustment of Warrants			$ (445,051)	$ 267,031
Fair Value Adjustment of Warrants			445,051	(267,031)
Private Warrants [Member]
Warrants and Rights Outstanding, Fair Value	$ 1,012,490		$ 1,012,490
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares	$ 11.50		$ 11.50
Share Price | $ / shares	$ 5.86		$ 5.86
Fair Value Adjustment of Warrants	$ 456,177	$ (178,021)	$ (445,051)	(267,031)
Fair Value Adjustment of Warrants	$ (456,177)	$ 178,021	$ 445,051	$ 267,031
Private Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants and Rights Outstanding, Measurement Input	0.0470		0.0470
Private Warrants [Member] | Measurement Input, Price Volatility [Member]
Warrants and Rights Outstanding, Measurement Input	0.7790		0.7790
Private Warrants [Member] | Measurement Input, Expected Term [Member]
Warrants and Rights Outstanding, Measurement Input	2.46		2.46

Note 9 - Fair Value Measurements - Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Warrant liability	$ 1,012,490	$ 567,439
Total	1,012,490	567,439
Fair Value, Inputs, Level 1 [Member]
Warrant liability		0
Total		0
Fair Value, Inputs, Level 2 [Member]
Warrant liability		0
Total		0
Fair Value, Inputs, Level 3 [Member]
Warrant liability	1,012,490	567,439
Total	$ 1,012,490	$ 567,439

Note 9 - Fair Value Measurements - Fair Value on Recurring Basis Unobservable Input Reconciliation (Details) - Fair Value, Recurring [Member] - Fair Value, Inputs, Level 3 [Member] - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Balance, beginning of period	$ 556,313	$ 283,720	$ 567,439	$ 372,730
Change in fair value of warrant liability	(456,177)	178,021	(445,051)	267,031
Balance, end of period	$ 1,012,490	$ 105,699	$ 1,012,490	$ 105,699

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