TICKERS: ZVRA

Rare Disease Co. Presents Positive Phase 2 KP1077 Data
Research Report

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Disclosures for Roth MKM, Zevra Therapeutics Inc., June 5, 2024

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

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Biotechnology / Pharmaceuticals

Source: Dr. Jonathan Aschoff (6/6/24)

Zevra Therapeutics Inc. (ZVRA:NASDAQ) recently presented positive final results from its Phase 2 trial evaluating KP1077 in idiopathic hypersomnia (IH) patients at the SLEEP 2024 conference, according to a Roth MKM research note.

Roth MKM analyst Dr. Jonathan Aschoff, in a research report published on June 5, 2024, provided an update on Zevra Therapeutics Inc. (ZVRA:NASDAQ) following the company's presentation of positive final results from its Phase 2 trial evaluating KP1077 in idiopathic hypersomnia (IH) patients at the SLEEP 2024 conference. The analyst maintains a Buy rating on Zevra Therapeutics and a 12-month price target of US$19.00.

"On Monday at the SLEEP 2024 conference, ZVRA presented positive final results from its Phase 2 trial evaluating KP1077 in idiopathic hypersomnia patients," Aschoff noted. "The results were enough to usefully inform the design of a Phase 3 trial, and we believe that such a trial will enroll at least 100 patients, treat for longer given that it takes placebo about three-four weeks to return to baseline, be of the same randomized withdrawal design (typical for an indication like IH and narcolepsy), and be randomized 2:1."

The Phase 2 trial highlights included statistically significant results with twice-daily (BID) dosing for the Epworth Sleepiness Scale (ESS; p=0.005) and Idiopathic Hypersomnia Severity Scale (IHSS; p=0.013) endpoints during the randomized controlled two weeks for KP1077 versus placebo, and a trend for Brain Fog Scale (BFS; p=0.06). KP1077 was well-tolerated regardless of dose or dosing regimen, with adverse events (AEs) being similar to other methylphenidate products.

"We believe that a Phase 3 trial will enroll at least 100 patients, treat for longer given that it takes placebo about three to four weeks to return to baseline, be of the same randomized withdrawal design (typical for an indication like IH and narcolepsy), and be randomized 2:1," Aschoff stated. "Alternatively a 1:1 randomized Phase 3 trial could enroll fewer patients."

Another poster presented at the conference described the pharmacokinetics (PK) of morning and nighttime KP1077 dosing, supporting nighttime dosing in IH patients who have difficulty waking up in the morning.

Roth MKM's 12-month price target of US$19 per share for Zevra Therapeutics is based on a discounted cash flow (DCF) analysis using a 15% discount rate applied to all cash flows and the terminal value, which is based on a 5x multiple of the firm's projected 2031 operating income of approximately US$272 million.

"Commercial success outside our modeled products and territories would provide upside to our valuation," Aschoff noted. The analyst also identified several factors that could impede the achievement of the target price, including failure or setbacks of pipeline candidates in clinical studies, failure of pipeline candidates to gain regulatory approval, departure of key personnel, and smaller than projected commercial opportunity due to changes in market size, competitive landscape, and drug pricing and reimbursement.

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Important Disclosures:

This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Roth MKM, Zevra Therapeutics Inc., June 5, 2024

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