false 0001742927 0001742927 2024-11-14 2024-11-14 0001742927 rvph:CommonStockParValue00001PerShareCustomMember 2024-11-14 2024-11-14 0001742927 rvph:WarrantsToPurchaseOneShareOfCommonStockCustomMember 2024-11-14 2024-11-14
 
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): November 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 November 14, 2024, disclosing financial information and operating metrics for its fiscal quarter ended September 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: November 14, 2024
By:
/s/ Narayan Prabhu
 
Name:
Title:
Narayan Prabhu
Chief Financial Officer
 
 

Exhibit 99.1

 

Reviva Reports Third Quarter 2024 Financial Results and Recent Business Highlights

 

– 108 patients have completed 1-year of treatment in 1-year open-label extension (OLE) trial

 

– Vocal biomarker speech latency data from RECOVER trial reinforce brilaroxazines improvement on negative symptoms and other key symptom domains of schizophrenia

 

– Topline data from OLE trial expected in December 2024

 

Cupertino, Calif., November 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 third quarter ended September 30, 2024 and summarized recent business highlights.

 

“We continue to advance our late-stage brilaroxazine program with initial focus in schizophrenia and expansion potential across indications driven by underlying disruption in serotonin signaling,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Our global 1-year OLE trial is progressing well, and we have over 100 patients who have completed one year of treatment which is a requirement for New Drug Application (NDA) submission. Importantly, we expect topline data from the OLE trial in December 2024. In addition to long-term safety, tolerability and efficacy, the full data analysis of the OLE trial expected in the first quarter of 2025 will also include vocal and blood biomarker data designed to support the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia. We remain highly encouraged by the differentiated potential of once-daily brilaroxazine to address major unmet needs for patients with schizophrenia and are targeting a potential NDA submission for brilaroxazine in the second quarter of 2026.”

 

Third Quarter 2024 and Recent Business Highlights

 

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 (November 2024).

 

 

o

Global trial progressing well

 

o

108 patients have completed 1-year (12-month) of treatment

 

o

Over 250 patients have completed 6-months of treatment

 

o

Blood and digital biomarkers designed to independently support efficacy

 

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

12 months long-term safety study expected to complete in Q1 2025

 

Presented vocal biomarker data from Phase 3 RECOVER trial of brilaroxazine in schizophrenia during a virtual key opinion leader event hosted by the Company featuring Brian Kirkpatrick, MD, MSPH (Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences, Arkansas) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York) (September 2024).

 

 

 

 

o

Speech latency is an emerging objective vocal biomarker that can help validate scale-based assessments completed by human raters

 

o

Brilaroxazine demonstrated a strong efficacy for negative symptoms and other key symptoms of schizophrenia such as total and positive symptoms, disorganization, and social functioning in the pivotal phase 3 RECOVER trial in schizophrenia

 

o

Statistically significant results of the vocal biomarker speech latency data analysis from the RECOVER trial further support the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia

 

Corporate Highlights

 

 

Positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial presented as a poster presentation at the Central Nervous System (CNS) Summit 2024 on Tuesday, November 12th in Boston, Massachusetts

 

Anticipated Milestones and Events

 

Topline data from 1-year OLE trial expected in December 2024

 

Full data analysis of the OLE trial including long-term safety, tolerability and efficacy, as well as vocal and blood biomarker data expected in Q1 2025

 

Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q1 2025, subject to receipt of additional financing

 

Potential NDA submission for brilaroxazine in schizophrenia targeted for Q2 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

 

Third Quarter 2024 Financial Results

 

The Company reported a net loss of approximately $8.4 million, or $0.25 per share, for the three months ended September 30, 2024, compared to a net loss of approximately $11.3 million, or $0.48 per share, for the same period in 2023 (as restated).

 

The Company reported a net loss of approximately $23.7 million, or $0.75 per share, for the nine months ended September 30, 2024, compared to a net loss of approximately $29.9 million, or $1.32 per share, for the same period in 2023 (as restated).

 

As of September 30, 2024, the Company’s cash totaled approximately $5.6 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

 

 

 

 

REVIVA PHARMACEUTICALS HOLDINGS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

September 30, 2024 and December 31, 2023

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Assets

               

Cash and cash equivalents

  $ 5,558,817     $ 23,367,456  

Prepaid clinical trial costs

    925,526       78,295  

Prepaid expenses and other current assets

    325,808       254,637  

Total current assets

    6,810,151       23,700,388  

Non-current prepaid clinical trial costs

    819,721        

Total Assets

  $ 7,629,872     $ 23,700,388  
                 

Liabilities and Stockholders' Equity (Deficit)

               
                 

Liabilities

               

Short-term debt

  $ 83,000     $  

Accounts payable

    8,777,579       3,849,108  

Accrued clinical expenses

    7,362,666       11,966,812  

Accrued compensation

    881,830       958,607  

Other accrued liabilities

    428,801       400,490  

Total current liabilities

    17,533,876       17,175,017  

Warrant liabilities

    77,884       806,655  

Total Liabilities

    17,611,760       17,981,672  
                 

Commitments and contingencies

               
                 

Stockholders' Equity (Deficit)

               

Common stock, par value of $0.0001; 115,000,000 shares authorized; 33,441,199 and 27,918,560 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

    3,344       2,792  

Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023

           

Additional paid-in capital

    148,028,341       140,070,172  

Accumulated deficit

    (158,013,573 )     (134,354,248 )

Total stockholders' equity (deficit)

    (9,981,888 )     5,718,716  
                 

Total Liabilities and Stockholders' Equity (Deficit)

  $ 7,629,872     $ 23,700,388  

 

 

 

 

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

For the Three and Nine Months Ended September 30, 2024 and 2023

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2024

   

2023

   

2024

   

2023

 
            (as restated)             (as restated)  

Operating expenses

                               

Research and development

  $ 6,858,285     $ 9,572,180     $ 18,226,497     $ 23,312,661  

General and administrative

    1,604,249       1,991,774       6,287,786       6,571,629  

Total operating expenses

    8,462,534       11,563,954       24,514,283       29,884,290  

Loss from operations

    (8,462,534 )     (11,563,954 )     (24,514,283 )     (29,884,290 )

Other income (expense)

                               

Gain (loss) on remeasurement of warrant liabilities

    72,321       139,079       728,771       (305,972 )

Interest expense

    (5,146 )     (5,901 )     (13,786 )     (20,414 )

Interest income

    53,248       91,763       313,956       341,854  

Other income (expense), net

    (23,687 )     5,194       (159,202 )     (15,220 )

Total other income, net

    96,736       230,135       869,739       248  

Loss before provision for income taxes

    (8,365,798 )     (11,333,819 )     (23,644,544 )     (29,884,042 )

Provision for income taxes

          12,117       14,781       21,531  

Net loss

  $ (8,365,798 )   $ (11,345,936 )   $ (23,659,325 )   $ (29,905,573 )
                                 

Net loss per share:

                               

Basic and diluted

  $ (0.25 )   $ (0.48 )   $ (0.75 )   $ (1.32 )
                                 

Weighted average shares outstanding

                               

Basic and diluted

    33,804,693       23,637,367       31,424,395       22,655,737  

 

 
v3.24.3
Document And Entity Information
Nov. 14, 2024
Document Information [Line Items]  
Entity, Registrant Name REVIVA PHARMACEUTICALS HOLDINGS, INC.
Document, Type 8-K
Document, Period End Date Nov. 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, 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

Reviva Pharmaceuticals (NASDAQ:RVPHW)
Historical Stock Chart
From Oct 2024 to Nov 2024 Click Here for more Reviva Pharmaceuticals Charts.
Reviva Pharmaceuticals (NASDAQ:RVPHW)
Historical Stock Chart
From Nov 2023 to Nov 2024 Click Here for more Reviva Pharmaceuticals Charts.