Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 14, 2024

REVIVA PHARMACEUTICALS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38634		85-4306526
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

10080 N Wolfe Road, Suite SW3-200, Cupertino, CA		95014
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (408) 501-8881

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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	Nasdaq Capital Market
Warrants to purchase one share of Common Stock	RVPHW	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02.

Results of Operations and Financial Condition.

Reviva Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release on August 14, 2024, disclosing financial information and operating metrics for its fiscal quarter ended June 30, 2024 and discussing its business outlook. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 7.01.

Regulation FD Disclosure.

See “Item 2.02 Results of Operations and Financial Condition” above.

The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

Item 9.01.

Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

Exhibit No.		Description
99.1		Press Release issued by Reviva Pharmaceuticals Holdings, Inc., dated August 14, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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 hereunto duly authorized.

	REVIVA PHARMACEUTICALS HOLDINGS, INC.

Date: August 14, 2024	By:	/s/ Narayan Prabhu
	Name: Title:	Narayan Prabhu Chief Financial Officer

Exhibit 99.1

Reviva Reports Second Quarter 2024 Financial Results and Recent Business Highlights

– Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 –

– Registrational RECOVER-2 trial in schizophrenia expected to initiate Q3 2024; topline data expected Q4 2025 –

– European patent granted covering brilaroxazine use for treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH) in any patients –

- U.S. patent granted covering use of brilaroxazine for the treatment of idiopathic pulmonary fibrosis (IPF) –

Cupertino, Calif., August 14, 2024 – Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the second quarter ended June 30, 2024 and summarized recent business highlights.

“Our late-stage brilaroxazine program continues to advance with topline data from our 1-year open-label extension trial evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia expected in the fourth quarter of the year,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We also further expanded our intellectual property for brilaroxazine to cover additional large markets for PH and IPF which are similarly driven by the underlying disruption in serotonin signaling. We believe brilaroxazine continues to show a differentiated safety and efficacy profile in the over 800 patients with schizophrenia treated to date in our trials, and we are highly encouraged by its broad therapeutic potential across indications.”

Second Quarter 2024 and Recent Business Highlights

Corporate Highlights

●

United States (U.S.) Patent 12053477 has been granted by the U.S. Patent and Trademark Office (USPTO) covering use of brilaroxazine for the treatment of idiopathic pulmonary fibrosis (IPF), adding to its existing patent protection in key markets around the world including Japan. Brilaroxazine has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of IPF (August 2024).

●

European Patent (EP3244896) granted by the European Patent Office (EPO) covering use of brilaroxazine for the treatment of pulmonary hypertension (PH), adding to its existing patent protection in key markets around the world including the United States, China and Japan. The European patent covers brilaroxazine use for treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH) in any patients and treating PH in patients with COPD or SCD. Brilaroxazine has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of PAH (July 2024).

Clinical Program Highlights

●	Provided an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia (August 2024).

Trial progressing as expected in the USA, Europe (Bulgaria) and Asia (India)

424 patients enrolled in the study; 230 patients currently on treatment in the study

65 patients have completed 12 months of treatment

53 patients who completed 9 months treatment currently in the study

About 200 patients completed 6 months of treatment

Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA

Reviva is on track to complete the 12 months long-term safety study in Q4 2024

●	Announced alignment with FDA on registrational Phase 3 program for brilaroxazine in schizophrenia (April 2024)

Acceptance of a 4-week RECOVER-2 study

Indication that two positive Phase 3 studies showing efficacy at week 4 that are accompanied by long-term safety data of at least 12 months could be supportive of an NDA submission for the acute treatment of schizophrenia

Requirement of a long-term randomized withdrawal study post-approval to support maintenance of effect

●	Presented successful RECOVER Phase 3 clinical trial data for brilaroxazine in schizophrenia at the 2024 Schizophrenia International Research Society (SIRS) Annual Meeting (April 2024)

Anticipated Milestones and Events

●	Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q3 2024

●	Topline data from 1-year open-label extension (OLE) trial expected Q4 2024

●	Topline data from registrational Phase 3 RECOVER-2 trial expected Q4 2025

●	Potential NDA submission for brilaroxazine in schizophrenia targeted for Q1 2026

●	Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2025

●	Pursue partnership opportunities for the development of our pipeline

Second Quarter 2024 Financial Results

The Company reported a net loss of approximately $7.9 million, or $0.26 per share, for the three months ended June 30, 2024, compared to a net loss of approximately $11.7 million, or $0.52 per share, for the same period in 2023 (as restated).

The Company reported a net loss of approximately $15.3 million, or $0.51 per share, for the six months ended June 30, 2024, compared to a net loss of approximately $18.6 million, or $0.84 per share, for the same period in 2023 (as restated).

As of June 30, 2024, the Company’s cash totaled approximately $6.2 million compared to approximately $23.4 million as of December 31, 2023.

About Brilaroxazine

Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathobiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).

Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathobiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions.

To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

About Reviva

Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Corporate Contact:

Reviva Pharmaceuticals Holdings, Inc.

Laxminarayan Bhat, PhD

www.revivapharma.com

Investor Relations Contact:

LifeSci Advisors, LLC

Bruce Mackle

bmackle@lifesciadvisors.com

Media Contact:

Kristin Politi

kpoliti@lifescicomms.com

(646) 876-4783

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

June 30, 2024 and December 31, 2023

	June 30,			December 31,
	2024			2023
Assets
Cash and cash equivalents	$	6,178,180		$	23,367,456
Prepaid clinical trial costs		528,947			78,295
Prepaid expenses and other current assets		525,826			254,637
Total current assets		7,232,953			23,700,388
Non-current prepaid clinical trial costs		819,721			—
Total Assets	$	8,052,674		$	23,700,388

Liabilities and Stockholders' Equity (Deficit)

Liabilities
Short-term debt	$	207,500		$	—
Accounts payable		4,693,360			3,849,108
Accrued clinical expenses		7,301,782			11,966,812
Accrued compensation		1,295,978			958,607
Other accrued liabilities		445,371			400,490
Total current liabilities		13,943,991			17,175,017
Warrant liabilities		150,205			806,655
Total Liabilities		14,094,196			17,981,672

Commitments and contingencies

Stockholders' Equity (Deficit)
Common stock, par value of $0.0001; 115,000,000 shares authorized; 29,817,294 and 27,918,560 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively		2,982			2,792
Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023		—			—
Additional paid-in capital		143,603,271			140,070,172
Accumulated deficit		(149,647,775	)		(134,354,248	)
Total stockholders' equity (deficit)		(6,041,522	)		5,718,716

Total Liabilities and Stockholders' Equity (Deficit)	$	8,052,674		$	23,700,388

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

For the Three and Six Months Ended June 30, 2024 and 2023

	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023
Operating expenses				(as restated)						(as restated)
Research and development	$	5,584,347		$	8,256,336		$	11,368,212		$	13,740,481
General and administrative		2,545,296			3,079,301			4,683,537			4,579,855
Total operating expenses		8,129,643			11,335,637			16,051,749			18,320,336
Loss from operations		(8,129,643	)		(11,335,637	)		(16,051,749	)		(18,320,336	)
Other income (expense)
Gain (loss) on remeasurement of warrant liabilities		200,273			(456,177	)		656,450			(445,051	)
Interest expense		(5,153	)		(12,759	)		(8,640	)		(20,414	)
Interest income		87,610			103,080			260,708			250,091
Other expense, net		(5,621	)		(19	)		(135,515	)		(14,513	)
Total other income (expense), net		277,109			(365,875	)		773,003			(229,887	)
Loss before provision for income taxes		(7,852,534	)		(11,701,512	)		(15,278,746	)		(18,550,223	)
Provision for income taxes		7,385			6,436			14,781			9,414
Net loss	$	(7,859,919	)	$	(11,707,948	)	$	(15,293,527	)	$	(18,559,637	)

Net loss per share:
Basic and diluted	$	(0.26	)	$	(0.52	)	$	(0.51	)	$	(0.84	)

Weighted average shares outstanding
Basic and diluted		30,555,012			22,434,781			30,221,168			22,135,850

Document And Entity Information	Aug. 14, 2024
Document Information [Line Items]
Entity, Registrant Name	REVIVA PHARMACEUTICALS HOLDINGS, INC.
Document, Type	8-K
Document, Period End Date	Aug. 14, 2024
Entity, Incorporation, State or Country Code	DE
Entity, File Number	001-38634
Entity, Tax Identification Number	85-4306526
Entity, Address, Address Line One	10080 N Wolfe Road
Entity, Address, Address Line Two	Suite SW3-200
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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0001742927
CommonStockParValue00001PerShare Custom [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
WarrantsToPurchaseOneShareOfCommonStock Custom [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