Reviva Pharmaceuticals Holdings, Inc. is a biotechnology and pharmaceutical company focusing on the discovery, development, and potential commercialization of next-generation therapeutics targeting high unmet medical needs.

# Company Summary: Reviva Pharmaceuticals Holdings, Inc.

## Overview
- **Industry:** Biotechnology / Pharmaceutical
- **Focus:** Discovery, development, and potential commercialization of next-generation therapeutics targeting diseases with high unmet medical needs.
- **Pipeline Focus Areas:**  
  - Central Nervous System (CNS) disorders  
  - Inflammatory diseases  
  - Cardiometabolic diseases

## Current Product Candidates
- **Brilaroxazine (RP5063):**  
  - **Type:** Novel chemical entity; serotonin, dopamine, and nicotinic receptor modulator.  
  - **Status:** In clinical development, including Phase 3 trials.  
  - **Indications Targeted:**  
    - Schizophrenia (primary focus, with positive topline Phase 3 RECOVER-1 trial results)  
    - Bipolar Disorder (BD)  
    - Major Depressive Disorder (MDD)  
    - Attention-Deficit/Hyperactivity Disorder (ADHD)  
    - Behavioral and Psychotic Symptoms of Dementia (BPSD)  
    - Parkinson’s Disease Psychosis (PDP)  
    - Pulmonary Arterial Hypertension (PAH) (orphan drug designation granted)  
    - Idiopathic Pulmonary Fibrosis (IPF) (orphan drug designation granted)  
    - Psoriasis (preclinical development)  

- **RP1208:**  
  - **Type:** New chemical entity; triple reuptake inhibitor (DAT, SERT, NET).  
  - **Status:** Preclinical; ready for IND-enabling studies for depression and animal efficacy studies for obesity.  
  - **Potential Indications:** Depression and Obesity.

## Clinical Data Highlights
- **Brilaroxazine (RP5063):**  
  - **Latest Results:** Positive topline Phase 3 RECOVER-1 data (October 30, 2023) showing significant improvement in schizophrenia symptoms.  
  - **Safety Profile:** Well tolerated, no serious adverse events, with low rates of extrapyramidal symptoms and weight change.  
  - **Ongoing Trials:**  
    - Long-term open-label extension (OLE) with over 250 patients enrolled; 108 completed 1 year of treatment.  
    - Registrational Phase 3 Trial (RECOVER-2) planned for mid-2025, topline results expected in Q3-2026.  
  - **Market Potential:** Significant, with anticipated NDA submission in Q4 2026.

## Employees and Customers
- **Employees:** 14 full-time employees.
- **Customers / Market:**  
  - The company currently has no product revenues or commercialized products.
  - No current customers; future sales depend on successful regulatory approval and commercialization of lead candidates.

## Revenue and Income
- **2024 Revenue:** None; the company has not generated any product revenue.
- **2024 Income:**  
  - Reported a net loss of **$29.9 million** for the year ended December 31, 2024.
  - Negative cash flow from operations: **$33.5 million**.
  - **Cash and equivalents as of December 31, 2024:** **$13.5 million**.
- **Financial Position:**  
  - **Accumulated deficit:** **$164.3 million**.
  - The company is in early-stage biotech development with ongoing clinical trials and no current products generating revenue.
  
## Additional Notes
- The company is heavily reliant on the success of its lead candidate, brilaroxazine.
- As of the date of the report, it has not submitted any NDA for approval.
- The company is in late-stage clinical development but has not yet reached commercialization.

Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapeutics for neuropsychiatric conditions and respiratory diseases.

# Reviva Pharmaceuticals Holdings, Inc. Overview

## Company Description
Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company that focuses on the discovery, development, and commercialization of next-generation therapeutics targeting significant unmet medical needs across various disease areas. The company leverages a chemical genomics-driven technology platform and proprietary chemistry to create new medications.

## Current Pipeline
Reviva's pipeline centers on:

1. **Brilaroxazine (RP5063)**:
   - A multimodal modulator of serotonin, dopamine, and nicotinic receptors.
   - Targets multiple neuropsychiatric conditions, including:
     - Schizophrenia
     - Bipolar Disorder (BD)
     - Major Depressive Disorder (MDD)
     - Attention-Deficit/Hyperactivity Disorder (ADHD)
     - Behavioral and Psychotic Symptoms of Dementia and Alzheimer's Disease (BPSD)
     - Parkinson's Disease Psychosis (PDP)
   - Also in clinical development for two respiratory diseases:
     - Pulmonary Arterial Hypertension (PAH)
     - Idiopathic Pulmonary Fibrosis (IPF)
   - **Orphan Drug Designation** granted for both PAH and IPF.

2. **RP1208**:
   - A new chemical entity currently in preclinical development.
   - Intended for treating depression and obesity.

## Recent Developments
- As of October 30, 2023, the company announced positive top-line results from the Phase 3 RECOVER-1 trial for brilaroxazine, demonstrating statistically significant reductions in schizophrenia symptoms.
- The company plans to initiate the global Phase 3 RECOVER-2 trial in Q2 2024, with an anticipated NDA submission to the FDA in 2025.

## Employment and Financial Details
- **Number of Employees**: 15 full-time employees.
- **Revenue**: The company has not generated any product revenue as of December 31, 2023.
- **Net Income**: Reported a loss of $39.3 million for the year ended December 31, 2023.
- **Accumulated Deficit**: $134.4 million as of December 31, 2023.
- **Cash and Cash Equivalents**: $23.4 million as of December 31, 2023.

## Strategic Objectives
Reviva aims to complete the clinical development of brilaroxazine and successfully navigate regulatory challenges to bring its products to market. The company intends to establish partnerships and collaborations to aid in commercialization and expand its product pipeline.

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This overview captures key aspects of Reviva Pharmaceuticals, highlighting its focus areas, recent advancements, financial situation, and strategic plans for the future.

REVIVA PHARMACEUTICALS HOLDINGS, INC.

10-K / April 3, 2025

10-K / April 15, 2024

10-K / April 3, 2025

Company Summary: Reviva Pharmaceuticals Holdings, Inc.

Overview

Current Product Candidates

Clinical Data Highlights

Employees and Customers

Revenue and Income

Additional Notes