Keep Zevra Strong

We are confident in our strategy

Our decision to focus on rare diseases positions us to field a small, nimble commercial team that we believe can be highly effective and drive better return on capital than our results to date with an outlicensing model. As we move Zevra forward, we will continue leveraging our legacy platform to target internally discovered rare disease product opportunities and extend our pipeline assets' exclusivity through lifecycle management. In this way, we aim to bring transformational therapies – and hope – to patients with rare diseases and their families and create value for our shareholders.

Secure regulatory approval for our pipeline assets

Build top-tier commercial capabilities

Enhance our pipeline through targeted business development transactions

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Our Board and leadership team are highly qualified to continue driving Zevra’s transformation

The Board is fully engaged and has been deeply involved in our strategic evolution. The three Zevra directors nominated for re-election collectively bring decades of biotech and pharmaceutical experience, both as senior executives and as members of public company boards. Their valuable experience across such areas as drug development, medical, finance, business development and commercialization are essential to support Zevra’s continued execution of its growth strategy. Additionally, with recent management appointments, our leadership team added deep and relevant clinical and regulatory expertise, including success with multiple product launches.

Meet Our Board

We are advancing our clinical pipeline with capital to fund our development plans into 2026

We see the AZSTARYS® license as foundational to where we are as a company, and we look forward to the potential for growth through commercialization of arimoclomol and KP1077, if approved. There are numerous milestone opportunities anticipated for 2023 and beyond to drive value creation for shareholders. With $102.9 million in cash, cash equivalents and investments as of December 31, 2022, we expect our available capital will fund Zevra through its upcoming milestones. Ongoing revenue from our arimoclomol Early Access Program (EAP) in France and the potential to realize additional sales milestones and revenue for AZSTARYS® could provide further capital flexibility and lengthen our cash runway, which already extends into 2026.

We continue our ongoing discussions with regulatory agencies and are preparing to refile the arimoclomol New Drug Application as a treatment for Niemann-Pick disease type C (“NPC”) as soon as the third quarter of this year.

For the KP1077 program in rare sleep disorders, we are on track to file an Investigation New Drug (IND) application for KP1077 in narcolepsy in the second quarter of this year.

For KP1077, we also anticipate interim data from the Phase 2 trial in idiopathic hypersomnia (IH) as early as the third quarter, with top-line results expected by the end of this year. Those data have the potential to not only support the advancement of KP1077 into a pivotal Phase 3 study in IH, but also may support a Phase 3 trial in narcolepsy.

We are uniquely positioned as a development-stage company with growing revenue to bolster our already strong financial position

We continue to have a solid balance sheet, and adding the arimoclomol program has begun to generate steady revenue to support our ongoing regulatory and product development initiatives. This includes reimbursements from the French EAP, the arimoclomol NDA resubmission, the complete development program for KP1077 through NDA submission and the FDA’s potential PDUFA date, as well as our preparations for the possible U.S. launch of arimoclomol, if approved. In addition, under our AZSTARYS® license agreement, we anticipate that the current prescription trend will allow us to earn at least one, and possibly two, of the sales milestones this year.

We are confident in our team, our strong financial foundation and diverse portfolio of multiple clinical programs, and our ability to deliver value in 2023 and beyond.

Investor FAQ

We urge you to protect the value of your investment in Zevra by voting on the WHITE proxy card “FOR” the re-election of your highly experienced and qualified Board nominees, Richard W. Pascoe, David S. Tierney, M.D., and Christopher A. Posner.

DO NOT vote for the Mangless nominees.
Vote “AGAINST” the Mangless Proposal.

How to Vote

support the right strategy and board for zevra