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Sep 30, 2022
Zevra Q3 2022 Earnings Report
Reported financial results, made progress with arimoclomol NDA resubmission, and advanced key activities to initiate a Phase 2 clinical trial of KP1077 in IH.
Key Takeaways
KemPharm reported Q3 2022 financial results with a net revenue of $2.9 million. The company is progressing with the arimoclomol NDA resubmission and advancing KP1077 for a Phase 2 clinical trial in IH. With $107.4 million in cash, the company's cash runway extends into 2026.
Made substantial progress with arimoclomol, anticipating NDA resubmission as early as Q3 2023.
Reported positive initial results from the Phase 1 cardiovascular safety trial of SDX for KP1077.
On track to initiate a Phase 2 clinical trial of KP1077 in IH by the end of 2022.
Possess a strong financial foundation with a cash runway extending into 2026.
Zevra
Zevra
Forward Guidance
KemPharm is focused on advancing its arimoclomol and KP1077 programs, with key milestones expected in the near term. The company anticipates resubmitting the NDA for arimoclomol as early as Q3 2023 and initiating a Phase 2 clinical trial of KP1077 in IH by the end of 2022. A strong financial foundation supports these activities, with a cash runway extending into 2026.
Positive Outlook
- Anticipating resubmission of the updated NDA as early as Q3 2023
- Ongoing collaborative dialogue and periodic meetings with the FDA intended to ensure an optimal NDA data package
- Preparing to initiate a Phase 2 clinical trial of KP1077 in patients with IH prior to year-end 2022
- Preparing a second trial in patients with narcolepsy in 2023
- Existing cash, cash equivalents and investments are expected to be sufficient to continue operations into 2026
Challenges Ahead
- No new or unanticipated issues related to resubmission have arisen; however, added time will be well-spent in preparation of an NDA filing with the highest likelihood of approval
- The potential to realize milestone and royalty revenue from AZSTARYS® depends on Corium's commercialization strategy
- R&D expenses increased due to the KP1077 clinical development program and the arimoclomol program
- G&A expenses increased due to increased compensation costs, professional fees, and depreciation/amortization
- Cash decreased by $7.1 million compared to June 30, 2022, driven by increased R&D costs and investment of working capital