Zevra Therapeutics Files 8-K Report

TL;DR

Zevra Therapeutics (ZEVRA) filed an 8-K on June 3rd, mostly financial docs & other events.

AI Summary

On June 3, 2024, Zevra Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. The company, formerly known as KemPharm, Inc., is incorporated in Delaware and headquartered in Celebration, Florida.

Why It Matters

This filing provides updated information and disclosures for Zevra Therapeutics, Inc., which is important for investors and stakeholders to stay informed about the company's status and activities.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report detailing financial statements and other events, not indicating any immediate operational or financial distress.

Key Players & Entities

• Zevra Therapeutics, Inc. (company) — Registrant
• KemPharm, Inc. (company) — Former company name
• June 3, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• Celebration, FL (location) — Address of Principal Executive Offices

FAQ

Filing Documents

• zvra20240530c_8k.htm (8-K) — 49KB
• ex_681567.htm (EX-99.1) — 37KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-019074.txt ( ) — 236KB
• zvra-20240603.xsd (EX-101.SCH) — 3KB
• zvra-20240603_def.xml (EX-101.DEF) — 11KB
• zvra-20240603_lab.xml (EX-101.LAB) — 15KB
• zvra-20240603_pre.xml (EX-101.PRE) — 11KB
• zvra20240530c_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 3, 2024, Zevra Therapeutics, Inc., a Delaware corporation (the Company), issued a press release announcing that the final results from its placebo-controlled, double-blind Phase 2 Clinical Trial evaluating the safety and tolerability of KP1077 (serdexmethylphenidate or SDX) in patients with idiopathic hypersomnia (IH)) were presented in a poster at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society held in June 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. As noted in Item 7.01 above, on June 3, 2024, the Company announced final results from the Phase 2 Clinical Trial of KP1077 for IH. The proof-of-concept study was designed to demonstrate safety and tolerability and was not powered to demonstrate statistical significance. However, the trial included several important secondary and exploratory endpoints, such as the change in Epworth Sleepiness Scale (ESS) total score, the IH Severity Scale (IHSS), the Sleep Inertia Visual Analog Scale (SIVAS), and a new scale to assess the symptoms and severity of brain fog. These data gathered from the secondary endpoints will help inform the study design for a potential Phase 3 clinical trial of KP1077. Key Takeaways from Phase 2 Clinical Trial of KP 1077 for Idiopathic Hypersomnia include: KP1077 was well tolerated at all dose levels evaluated in the trial, including the highest dose of 320 mg daily, regardless of the dosing regimen: once daily (QD) or twice daily (BID). o Adverse events (AEs) were similar to other methylphenidate products o Most common AEs included insomnia, headache, anxiety, decreased appetite, and nausea o Most AEs occurred during the titration period, were mild, and did not lead to early discontinuation KP1077 produced clinically meaningful improvements in EDS as assessed by change from baseline in the ESS during both the 5-week open-label (OL) titration period which was maintained during the 2-week double-blind withdrawal period for both dosing regimens. o Mean total ESS scores decreased by approximately 9 points after 5 weeks of OL treatment. At the end of 7 weeks of treatment, patients administered KP1077 showed clinically meaningful benefits in change from baseline for the ESS, IHSS, SIVAS, and Brain Fog Scale (BFS): o Mean total ESS score decreased by 9.4 (QD) and 8.8 (BID) o Mean total IHSS score decreased by 16.1 (QD) and 12.3 (BID) o Mean SIVAS score decreased by 25.9 (QD) and 17.2 (BID) o Mean total BFS

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed: (d) Exhibits Exhibit No. Description 99.1 Press Release dated June 3, 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. Zevra Therapeutics, Inc . Date: June 3, 2024 By: /s/ Timothy J. Sangiovanni Timothy J. Sangiovanni, CPA Senior Vice President, Corporate Controller

View Full Filing

View this 8-K filing on SEC EDGAR