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KZR

Kezar Life Sciences, Inc.

Kezar Life Sciences, Inc. Q2 FY2020 earnings call

August 9, 2020 · fiscal period ended 2020-06

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Summary

Generated 2020-08-09

Management highlights

  • Praised team's dedication during COVID-19. - Discussed reevaluation of KZR-616 clinical strategy, including updates on MISSION, PRESIDIO, and MARINA trials. - KZR-261 progress in protein secretion platform, planning to submit IND in Q1 2021. - Financials: Cash, cash equivalents, and marketable securities totaled $157.5 million as of June 30, 2020; R&D expenses increased to $7.1 million in Q2 2020; G&A expenses increased to $2.7 million; net loss was $9.5 million.
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Segment performance

No detailed segment performance with revenue contribution percentages provided in the transcript. Focus is on clinical development and financials.

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Guidance

  • Reevaluated clinical strategy for KZR-616 based on trial slowdowns and updated results. - Plan to submit IND for KZR-261 in Q1 2021. - Cash runway of $157.5 million provides ample runway through 2023.
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Risks

  • Impact of COVID-19 on clinical trial recruitment and enrollment. - Uncertainties in clinical trial outcomes and efficacy of drug candidates. - Regulatory and safety risks associated with drug development.
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Q&A highlights

Q: What factors predominantly contributed to better tolerability on Cohort 2c?

A: Better tolerability was due to a combination of moving to a lyophilized formulation, step-up dosing, and supportive measures for patients and physicians.

Q: To the new formulation, does this basically make the drug more stable or what is special about it?

A: It does not change stability but removes an excipient (polysorbate 80) to simplify formulation for patient self-administration.

Q: When do you think we could expect another update from the Stage 1b MISSION study and how many patients do you think we should expect in that data? Has the progression of the trial been impacted by COVID-19 at all?

A: Goal is to provide interim update by end of year, fully enrolled third cohort this month, and progression impacted with slowing enrollment now looking to mid-2022 for PRESIDIO.

Q: Could you just elaborate on that a 50% reduction in proteinuria is associated with long term clinical benefit in patients with LN?

A: Proteinuria reduction is a standard benchmark as it's a sign of disease activity, and 50% reduction is correlated with long-term clinical benefit.

Q: With regard to the discontinuation of the MARINA study, what was driving the highest screening failure rate?

A: MARINA had no patients enrolled, with exclusion criteria not reflecting real-world conditions, leading to study withdrawal.

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Transcript

August 9, 2020

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