Clearside Biomedical, Inc. Q1 FY2023 earnings call

CLS-AX Progress

• OASIS trial and extension study showed CLS-AX had excellent safety and tolerability, 2/3 of wet AMD patients in higher dose cohorts went at least 6 months without additional treatment, with 77-85% reduction in treatment burden.
• Plans for Odyssey trial, a Phase 2b randomized double-masked multi-centered trial in wet AMD, aiming to demonstrate improved duration and reduced treatment burden while maintaining visual acuity. Enrollment to open in next few weeks, targeting 30 US clinical trial sites, with top line data expected in Q3 2024.

XIPERE Updates

• Survey data from ARVO showed early adopters of XIPERE found suprachoroidal injection easy to learn, with patient improvements aligning with clinical trial findings.
• Bausch & Lomb expanding outreach in US/Canada, filed for XIPERE in Canada. Arctic Vision enrolling confirmatory Phase 3 trial for macular edema and completed Phase 1 for diabetic macular edema.

SCS Microinjector Partners

• REGENXBIO completed enrollment in Phase 2 trials using SCS delivery, AbbVie took over IND sponsorship for RGX-314. Aura Biosciences planning global Phase 3 trial for colloidal melanoma using SCS Microinjector.

Scientific Advisory Board

• Enhanced scientific advisory board with new members, instrumental in trial design.

Financial Status

• Cash and cash equivalents ~$41.4M as of March 31, 2023, sufficient to fund operations into Q2 2024.

No specific financial performance data for product segments in absolute terms or revenue contribution % provided in the transcript.

Odyssey Trial

• Trial to open for enrollment in next few weeks, expecting to enroll first patient shortly after.
• Target 30 US clinical trial sites for Odyssey.

Financial

• Cash resources sufficient to fund operations into Q2 2024.

No specific risks discussed in detail in the provided transcript; forward-looking statements and risk factors mentioned in the 10-K but not detailed in the call.

Q: Couple questions, George. First, how should we think about successful outcome for Odyssey trial? Secondly, how to minimize retreatment criteria issues?

A: Odyssey not powered as non-inferiority, looking to show lower treatment burden, setting up data for Phase 3. Enhanced training, supervision, and protocols to minimize retreatment issues.

Q: How are potential changes in draft guidelines for wet AMD trial design impacting Odyssey?

A: FDA draft guidance, waiting for final guidelines, Odyssey designed to align with draft, cognizant of possible changes.

Q: Why minimize sub-responders in Odyssey?

A: Trying to get relevant population, homogeneous group, avoiding sub-responders to facilitate enrollment.

Q: Non-inferiority margins for BCVA in Odyssey?

A: Looking for comparable BCVA, within a couple letters, clinically acceptable.

Q: Meaningful result in terms of treatment burden reduction and duration?

A: Hoping significant percentage of patients go 5-6 months without rescue, vast majority of CLS-AX patients go 5-6 months without need for supplemental therapy.

Q: XIPERE commercial performance and license revenue projection?

A: Bausch + Lomb launched XIPERE, trained over 1,000 specialists, no insight into sales; no revenue forecast provided for partnerships.

Q: Long-lasting wet AMD treatment on treatment-naive patients?

A: Eventually, as data accumulates, extended duration treatment may become norm, but physician practices may change gradually.