Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Positive Phase 3 results for izokibep in hidradenitis suppurativa, meeting the primary endpoint of HiSCR75.
- Compelling response rates in HiSCR90 and HiSCR100 within 12 weeks of treatment for izokibep.
- Refocused pipeline strategy designed to extend cash runway to mid-2027.
- Ongoing Phase 2b/3 trial in uveitis with top-line data expected in Q4 2024.
- Strong financial position with a cash position of approximately $635 million as of June 30, 2024.
Negative Points
- Decision to stop internal development of SLRN-517, despite demonstrating molecular activity in healthy volunteers.
- Approximately 33% reduction in workforce as part of the organizational restructuring.
- No new trials will be started for izokibep in HS and PsA, limiting future development in these indications.
- Increased R&D expenses, primarily due to the izokibep program, leading to higher operational costs.
- Projected cash used in operations to increase substantially in the second half of 2024.
Q & A Highlights
Q: What's the rationale for adding the 70-mg dose in the ongoing Phase 2 for lonigutamab? Also, the every three-week dosing arm as well, just wanted to also figure out whether this is kind of leading to potentially a loading dose in Phase 3?
A: We are adding the 70-mg dose to complete dose exploration in the Phase 2 trial rather than in a 2b/3 as originally planned. This allows us to move directly into a Phase 3 program and potentially run two Phase 3 trials concurrently, which could accelerate the program. We are looking at both three-week and four-week regimens to confirm the dose for the pivotal program. We think we have our dose, but regimen is also important. (Mina Kim, CEO)
Q: Is the plan to partner the izokibep asset right now, or is it just going on the shelf? And what are the plans for uveitis if the data looks good?
A: We are open to all options for izokibep, including partnering with a larger organization that has existing capabilities and infrastructure. We have not included any financing proceeds or proceeds from a partnership in our cash runway guidance. For uveitis, we will evaluate the totality of the data, the market, and the unmet need before making a decision. (Mina Kim, CEO)
Q: What would compelling data from the Phase 3 uveitis trial look like later this year that would lead you to pursue another trial for registration?
A: The trial is designed similarly to the HUMIRA trial, with patients receiving steroids at baseline and then tapering off over 15 weeks. The primary efficacy endpoint at week 24 includes four parameters: chorioretinal inflammation, vitreous haze, anterior chamber inflammation, and best corrected visual acuity. Compelling data would show more patients on placebo versus drug achieving this endpoint. (Shephard Mpofu, CMO)
Q: Could you provide more details on the tinnitus observed in Cohort 1 of the lonigutamab trial? Why was it only in Cohort 1 and not in Cohort 2?
A: We have not seen any specific reason why tinnitus occurred in Cohort 1. The tinnitus was transient and resolved in the majority of the three patients. None of the patients in Cohort 2 experienced tinnitus, and all patients undergo audiograms at baseline and throughout the study. We have not seen any sensorineural hearing loss or impairment. (Shephard Mpofu, CMO)
Q: Are you targeting more refractory patients in the uveitis trial, like those who are on or after prior biologic use? Will uveitis be considered an orphan indication, and could you potentially get orphan pricing?
A: The trial includes patients with active, non-infectious uveitis, including those previously exposed to other biologics, except those targeting the IL-17 pathway. It's too early to speculate on pricing, but we believe there is a high unmet need and limited therapeutic options, which could justify orphan pricing. (Gil Labrucherie, CFO & CBO; Shephard Mpofu, CMO)
Q: What are the main questions you hope to have answered at the end-of-Phase 2 meeting with the FDA for lonigutamab?
A: The end-of-Phase 2 meeting will focus on discussing the benefit-risk profile, dose selection, and study designs for the Phase 3 program. We aim to get agreement from the FDA on these aspects to proceed with the Phase 3 trials. (Shephard Mpofu, CMO)
Q: What did you see in the early stage of development for SLRN-517 that led to the decision to stop pursuing it further?
A: We conducted a healthy volunteer study, and the data is available on our website. The decision to stop pursuing SLRN-517 was a strategic prioritization to focus on other programs. (Mina Kim, CEO)
Q: Can you confirm that you haven't seen any cases of hearing impacts from any of the lonigutamab cohorts so far?
A: Yes, we have not seen any notable hearing impairment or sensorineural hearing loss in any of the dose groups. There were three cases of transient tinnitus in Cohort 1, but none in Cohort 2, and no changes in audiograms were observed. (Shephard Mpofu, CMO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
