Reviva Pharmaceuticals Files 8-K

TL;DR

REVIVA files 8-K, check for updates.

AI Summary

Reviva Pharmaceuticals Holdings, Inc. filed an 8-K on December 16, 2024, reporting on other events and financial statements. The company, formerly Tenzing Acquisition Corp., is incorporated in Delaware and headquartered in Cupertino, CA.

Why It Matters

This filing provides an update on the company's corporate activities and financial reporting, which is crucial for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — The filing is a routine corporate disclosure and does not appear to contain significant negative news.

Key Numbers

• 001-38634 — Commission File Number (Identifies the company's SEC filing history)
• 85-4306526 — IRS Employer Identification No. (Company's tax identification number)

Key Players & Entities

• REVIVA PHARMACEUTICALS HOLDINGS, INC. (company) — Registrant
• Tenzing Acquisition Corp. (company) — Former company name
• December 16, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• Cupertino, CA (location) — Business address

FAQ

Key Financial Figures

• $0.0001 — registered Common Stock, par value $0.0001 per share RVPH Nasdaq Capital Marke

Filing Documents

• rvph20241215_8k.htm (8-K) — 46KB
• ex_757662.htm (EX-99.1) — 30KB
• img01.jpg (GRAPHIC) — 1KB
• 0001437749-24-037520.txt ( ) — 237KB
• rvph-20241216.xsd (EX-101.SCH) — 4KB
• rvph-20241216_def.xml (EX-101.DEF) — 14KB
• rvph-20241216_lab.xml (EX-101.LAB) — 18KB
• rvph-20241216_pre.xml (EX-101.PRE) — 14KB
• rvph20241215_8k_htm.xml (XML) — 5KB

01

Item 7.01. Regulation FD Disclosure. On December 16, 2024, Reviva Pharmaceuticals Holdings, Inc. (the "Company") issued a press release announcing positive preliminary topline data for the open-label extension (the "OLE") portion of the Company's ongoing Phase 3 RECOVER trial evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Current Report on Form 8-K under Item 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, as amended (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, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

01

Item 8.01. Other Events. On December 16, 2024, the Company announced positive preliminary topline data from its OLE evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. Administration of brilaroxazine once daily led to robust broad-spectrum efficacy that was sustained over 1 year. Brilaroxazine was generally well tolerated with no single side effect >5% and favorable compliance, with a discontinuation rate of 35% in the OLE part of this study. All three doses of brilaroxazine (15 mg, 30 mg and 50 mg) tested were efficacious and generally well-tolerated. Key safety, efficacy and compliance findings for pooled analysis of brilaroxazine at 15, 30, and 50 mg include: A total number of 435 patients were enrolled in the OLE across three dose groups: 139 in brilaroxazine 15 mg, 155 in brilaroxazine 30mg and 141 in brilaroxazine 50mg 156 (35.86%) rollover participants from the double-blind portion of the Phase 3 trial, while 279 (64.13%) de novo participants enrolled in the OLE Preliminary efficacy results are presented for 113 patients who completed 52 weeks (1 year) of treatment; preliminary safety results are presented for all 435 patients who enrolled in the OLE, including patients that are still participating in the trial Brilaroxazine across doses improved major symptom domains of schizophrenia after 1-year of treatment: Dose dependent efficacy at the 15, 30, and 50 mg doses was observed, with decreases in PANSS total scores of -15.2, -18.6 and -20.8 points, respectively, from baseline to end-of-treatment at 52 -week (1 -year) Pooled data of brilaroxazine at the 15, 30, and 50 mg doses (N = 113) demonstrated clinically meaningful and sustained long-term (1-year) efficacy for schizophrenia with a significant decrease in PANSS total scores, PANSS positive symptoms, and PANSS negative symptoms compared to baseline o PANSS Total scores: 18.6-point decrease (71.6 53), p 0.0001 o PANSS Positive Symptoms: 5.2-poin

Financial Statements and Exhibits

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 December 16, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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. Dated: December 16, 2024 By: /s/ Narayan Prabhu Name: Title: Narayan Prabhu Chief Financial Officer