false 0001742927 0001742927 2024-08-14 2024-08-14 0001742927 rvph:CommonStockParValue00001PerShareCustomMember 2024-08-14 2024-08-14 0001742927 rvph:WarrantsToPurchaseOneShareOfCommonStockCustomMember 2024-08-14 2024-08-14
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
 
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).

 

o

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

 

o

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

 

o

65 patients have completed 12 months of treatment

 

o

53 patients who completed 9 months treatment currently in the study

 

o

About 200 patients completed 6 months of treatment

 

o

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

 

o

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)

 

o

Acceptance of a 4-week RECOVER-2 study

 

o

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

 

o

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  

 

 
v3.24.2.u1
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

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