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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, 2023
 
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.)
     
19925 Stevens Creek Blvd., Suite 100, Cupertino, CA
 
95014
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (408) 501-8881
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
 
 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, 2023, disclosing financial information and operating metrics for its fiscal quarter ended September 30, 2023 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) Exhibits.
 
The following Exhibit 99.1 is furnished with this report:
 
Exhibit
Number
 
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, 2023
By:
/s/ Narayan Prabhu
 
   
Narayan Prabhu
 
   
Chief Financial Officer
 
 
 

Exhibit 99.1

 

Reviva Reports Third Quarter 2023 Financial Results and Recent Business Highlights

 

- RECOVER global Phase 3 trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo in schizophrenia

 

- Consistent Phase 3 RECOVER and Phase 2 REFRESH findings reinforce meaningful improvements across domains, well-tolerated safety, and low discontinuation rates for brilaroxazine vs. placebo

 

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

 

 

Cupertino, Calif., November 14, 2023 – 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), respiratory and metabolic diseases, today reported financial results for the third quarter ended September 30, 2023 and summarized recent business highlights.

 

“Our brilaroxazine clinical program continues to advance, and we were pleased to recently announce positive topline results for our global Phase 3 RECOVER trial in adults with schizophrenia. The RECOVER trial met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine compared to placebo,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Importantly, we saw generally consistent, clinically significant efficacy and safety findings across our Phase 2 REFRESH and Phase 3 RECOVER trials further reinforcing brilaroxazine’s competitive profile. We expect to report long-term data from our OLE trial in the fourth quarter of 2024 and initiate a registrational Phase 3 RECOVER-2 trial in the first quarter of 2024, which if successful will help support our planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) expected in 2025.”

 

Recent Business Highlights

 

 

 

Announced positive topline results and successful completion of Reviva’s pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine in adults with schizophrenia (October 2023)

 

 

o

Trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4.

 

 

o

Brilaroxazine achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo.

 

 

o

The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints and reached statistical significance on two key secondary endpoints.

 

 

 

 

o

Generally well-tolerated with a side effect profile comparable to placebo for the 15 and 50 mg doses of brilaroxazine; discontinuation rates for brilaroxazine lower than placebo.

 

 

Over 50% of patients currently enrolled in the 1-year OLE study for brilaroxazine in schizophrenia

 

Anticipated Milestones and Events

 

 

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

 

 

Initiation of a registrational Phase 3 RECOVER-2 trial expected Q1 2024

 

 

May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024

 

 

Submit investigational new drug application (IND) for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2024

 

 

Pursue partnership opportunities for the development of our pipeline

 

 

Evaluate grant and other non-dilutive financing opportunities for our product candidates from Federal and State Healthcare Agencies and Foundations

 

 

Third Quarter 2023 Financial Results

 

The Company reported a net loss of approximately $10.5 million, or ($0.44) per share, for the three months ended September 30, 2023, compared to a net loss of approximately $3.5 million, or ($0.18) per share, for the same period in 2022.

 

As of September 30, 2023, the Company’s cash totaled approximately $5.0 million compared to approximately $18.5 million as of December 31, 2022.

 

 

First Nine Months Fiscal Year 2023 Financial Results

 

The Company reported a net loss of approximately $29.5 million, or ($1.30) per share, for the nine months ended September 30, 2023, compared to a net loss of approximately $16.2 million, or ($0.87) per share, for the same period in 2022.

 

 

About Brilaroxazine

Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER 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 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 pharmaceutical 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, inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, RP5063 (brilaroxazine) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both RP5063 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, registrational global, randomized 6-week Phase 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, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential 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, 2022, 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

September 30, 2023 (unaudited) and December 31, 2022

 

   

September 30,

   

December 31,

 
   

2023

   

2022

 

Assets

               

Cash and cash equivalents

  $ 4,972,298     $ 18,519,856  

Prepaid expenses and other current assets

    414,743       403,819  
                 

Total Assets

  $ 5,387,041     $ 18,923,675  
                 

Liabilities and Stockholders' Equity

               
                 

Liabilities

               

Short-term debt

  $ 222,500     $  

Accounts payable

    5,278,375       3,520,271  

Accrued expenses and other current liabilities

    7,532,187       2,519,569  

Total current liabilities

    13,033,062       6,039,840  

Warrant liabilities

    873,411       567,439  

Total Liabilities

    13,906,473       6,607,279  
                 

Commitments and contingencies (Note 7)

               
                 

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 September 30, 2023, and December 31, 2022, respectively

    2,265       2,045  

Additional paid-in capital

    112,185,998       103,485,612  

Accumulated deficit

    (120,707,695 )     (91,171,261 )

Total stockholders' equity

    (8,519,432 )     12,316,396  
                 

Total Liabilities and Stockholders' Equity

  $ 5,387,041     $ 18,923,675  

 

 

 

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
For the Three and Nine Months Ended September 30, 2023 and 2022

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2023

   

2022

   

2023

   

2022

 

Operating expenses

                               

Research and development

  $ 8,717,273     $ 2,305,981     $ 22,943,522     $ 12,650,388  

General and administrative

    1,991,774       1,256,972       6,571,629       3,882,210  

Total operating expenses

    10,709,047       3,562,953       29,515,151       16,532,598  

Loss from operations

    (10,709,047 )     (3,562,953 )     (29,515,151 )     (16,532,598 )

Other (expense) income

                               

Gain (loss) on remeasurement of warrant liabilities

    139,079             (305,972 )     267,031  

Interest expense

    (5,901 )           (20,414 )      

Interest income

    91,763       53,150       341,854       68,710  

Other income (expense)

    5,194       (3,641 )     (15,220 )     (11,749 )

Total other (expense) income, net

    230,135       49,509       248       323,992  

Loss before provision for income taxes

    (10,478,912 )     (3,513,444 )     (29,514,903 )     (16,208,606 )

Provision for income taxes

    12,117       1,864       21,531       12,414  

Net loss

  $ (10,491,029 )   $ (3,515,308 )   $ (29,536,434 )   $ (16,221,020 )
                                 

Net loss per share:

                               

Basic and diluted

  $ (0.44 )   $ (0.18 )   $ (1.30 )   $ (0.87 )
                                 

Weighted average shares outstanding

                               

Basic and diluted

    24,033,665       19,269,989       22,775,407       18,737,330  

 

 

 

 

 

 

 
v3.23.3
Document And Entity Information
Nov. 14, 2023
Document Information [Line Items]  
Entity, Registrant Name REVIVA PHARMACEUTICALS HOLDINGS, INC.
Document, Type 8-K
Document, Period End Date Nov. 14, 2023
Entity, Incorporation, State or Country Code DE
Entity, File Number 001-38634
Entity, Tax Identification Number 85-4306526
Entity, Address, Address Line One 19925 Stevens Creek Blvd.
Entity, Address, Address Line Two 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
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity, Emerging Growth Company true
Entity, Ex Transition Period false
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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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