Chemomab Therapeutics Ltd.
Chemomab Therapeutics Ltd. Q2 FY2022 earnings call
August 12, 2022 · fiscal period ended 2022-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-08-12
Management highlights
• Progress on CM-101 clinical programs: Concluded treatment phase of Phase 2 Liver Fibrosis study, finalized plan revisions and initiated global regulatory filings for PSC Phase 2 trial expansion, and made progress on Systemic Sclerosis Phase 2 trial design. • IP portfolio updates: US Patent and Trademark Office issued a new method of use patent for CM-101 covering treatment of fibro-inflammatory liver diseases. • Preclinical data presentations: Presentations at European scientific meetings on CM-101's role in PSC, ECM expression, and Systemic Sclerosis. • Key hires: Added director and senior executives, including Christina Crater as VP of Clinical Development, Dylan Backman as VP of Research and Development, and mid-level professionals to enhance clinical and research capabilities.
Segment performance
No distinct product segments with revenue contributions to report as Chemomab focuses on a single main product (CM-101) with no separate product line financial breakdown.
Guidance
• Anticipate final readout of liver fibrosis study in fourth quarter of 2022. • Interim safety assessment of PSC trial expected by end of 2023. • Top line data from PSC Phase 2 trial expected in second half of 2024. • Planning a virtual event in fall to provide details on systemic sclerosis trial and to share final design details of Systemic Sclerosis trial in upcoming quarters.
Risks
• Market challenges for biotech stocks. • Uncertainties in clinical trial outcomes and regulatory approvals. • Potential differences between expected and actual results due to various risks and uncertainties outlined in SEC filings, including factors in risk factors sections of annual reports.
Q&A highlights
Q: Regarding the 5 mg subcutaneous dose in the NASH/liver fibrosis study, comparison of exposure to IV doses in PSC trial, interim safety readout on PSC trial, and timeline for systemic sclerosis trial results.
A: Subcutaneous formulation in Phase 1b had roughly 60% exposure of equivalent IV dose; interim safety analysis of PSC trial will be blind so detailed safety data won't be shared yet; systemic sclerosis trial design details to be shared via special webcast or next quarterly call with timing of top line/interim results dependent on final trial design.
Q: Timelines for PSC enrollment cadence, number of sites, and patient populations with comorbidities like IBD.
A: Expanding number of sites in EU and US for PSC trial; current timeline for top line data in second half of 2024 based on site expansion and historical enrollment rates in PSC; focusing initial trial on PSC patients with large duct disease and no active IBD but exploring patients with concurrent IBD in future as CM-101 has anti-inflammatory effects relevant to IBD.
Q: Focus of Phase 2 studies on safety and path to efficacy, and competence in running multiple mid-stage studies.
A: Phase 2 studies are safety-focused initially as primary outcome; in PSC, robust trial design could lead to direct registration studies depending on data; organization has key hires in clinical operations to competently run multiple mid-stage studies like Liver Fibrosis, PSC, and Systemic Sclerosis trials simultaneously.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.54 | $-0.60 | +10.0% | — |
| Revenue | — | — | — | — |
Transcript
August 12, 2022Full transcript unavailable for redistribution
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