Chemomab Therapeutics Ltd. (CMMB)·Q4 2022 Earnings Summary
Executive Summary
- Chemomab reported no product revenue and a FY 2022 net loss of $27.6M as operating expenses rose with Phase 2 program expansion; Q4 operating loss was broadly in line with recent quarters as R&D and G&A stepped up to support trials .
- Positive clinical updates were key: CM-101 met the primary endpoint (safety/tolerability) and showed multi-biomarker activity in a Phase 2a NASH fibrosis study, and the FDA cleared the IND to initiate a Phase 2 SSc trial, enhancing program visibility .
- PSC Phase 2 trial was expanded (dose-finding and OLE) with focus on higher doses after encouraging biomarker data at lower doses, positioning for topline in 2H 2024; management extended cash runway guidance to at least March 31, 2024, a modest improvement vs prior “end of 2023” commentary .
- Estimate context: S&P Global consensus EPS/revenue for Q4/FY 2022 was unavailable due to access limits; therefore, no beat/miss assessment is provided at this time.
What Went Well and What Went Wrong
What Went Well
- CM-101 Phase 2a in NASH achieved its primary endpoint (safety/tolerability) and showed improvement across multiple liver fibrosis biomarkers and physiologic measures; CEO: “this trial confirmed the safety and tolerability of CM-101…while providing biomarker data further demonstrating…activity” .
- FDA cleared the IND for the Phase 2 systemic sclerosis (SSc) trial (ABATE), with the primary outcome of safety and multiple biomarker/clinical secondary endpoints; CMO: “an important milestone…we look forward to initiating patient enrollment in the first half of this year” .
- PSC Phase 2 trial expansion—adding higher dose (20 mg/kg) and OLE—refined dose strategy after encouraging lower-dose signals elsewhere; management sees this facilitating timely conduct/completion (focus on 10 and 20 mg/kg) .
What Went Wrong
- Operating expenses rose sharply: R&D +168% YoY to $17.0M and G&A +92% YoY to $11.6M, widening FY net loss to $27.6M as the company invested in Phase 2 programs and organizational build-out .
- VAT audit risk: Israeli Tax Authority issued assessments aggregating ~$1.046M; the company recorded a provision but outcome remains uncertain .
- Funding dependence persists; while runway extended to March 31, 2024, management still expects to require significant additional capital to advance programs to key milestones .
Financial Results
Quarterly P&L snapshot (USD Millions, unless noted)
Annual YoY comparison (USD Millions, unless noted)
Liquidity snapshot (period-end, USD Millions)
Cash flow (FY 2022)
Notes: Q4 figures for R&D, G&A, Net Loss are calculated as FY 2022 minus 9M 2022 based on cited filings . Revenue remains $0 as Chemomab has no product sales .
Guidance Changes
Earnings Call Themes & Trends
Note: We did not locate a Q4 2022 earnings call transcript; themes for Q4 are derived from the FY 2022 8-K/MD&A and contemporaneous press releases. We read Q2 and Q3 call transcripts for trend context .
Management Commentary
- “It is noteworthy that this trial confirmed the safety and tolerability of CM-101 and the pharmacokinetics of our subcutaneous formulation, while providing biomarker data further demonstrating the anti-inflammatory and anti-fibrotic activity of CM-101.” — Dale Pfost, PhD, CEO, on NASH Phase 2a topline .
- “Achieving FDA clearance to initiate our Phase 2 systemic sclerosis trial is an important milestone for Chemomab.” — Matt Frankel, MD, CMO .
- “We are actively advancing CM-101 in Phase 2 clinical studies…expanding [PSC] by adding clinical sites, an additional high dose arm (20mg/kg) as well as an open label extension.” — FY 2022 MD&A .
- “We believe that our existing cash, cash equivalents and bank deposits will enable us to fund our operating expenses and capital expenditure requirements at least through March 31, 2024.” — FY 2022 liquidity outlook .
Q&A Highlights
(From Q3 2022 call; no Q4 call located)
- Patient enrichment in SSc by baseline CCL24: Company intends to enroll approximately ≥70–75th percentile CCL24 levels to enrich for biology and potential responders; correlations observed with disease activity and pulmonary outcomes .
- PSC study interim disclosure: Management weighed optional interim read on original 10 mg/kg cohort but is balancing data integrity/power; topline still targeted for 2H 2024 .
- Biomarker causality: Strategy is to test whether neutralizing elevated CCL24 translates to meaningful biomarker and clinical signals in enriched SSc subgroups .
Estimates Context
- We attempted to retrieve S&P Global consensus EPS and revenue for Q4 2022 and FY 2022; data was unavailable due to system request limits. As a result, we cannot provide beat/miss versus consensus at this time. Given Chemomab’s pre-revenue status and limited sell-side coverage, Street EPS/Revenue expectations may be sparse.
Key Takeaways for Investors
- Clinical momentum strengthened: positive NASH biomarker readout and SSc IND clearance de-risk the platform across organs and support the focus on PSC/SSc orphan indications .
- PSC trial execution is the main 2024 catalyst (2H topline); the shift to 10/20 mg/kg and OLE should optimize dose learning and durability assessments, albeit with no near-term efficacy read .
- Operating spend is intentionally elevated to fund Phase 2 execution; monitor quarterly burn versus the runway to Mar 31, 2024 and potential financing windows .
- Regulatory/legal overhang from VAT assessments (~$1.046M) is manageable but worth tracking to resolution .
- With no revenue and limited consensus coverage, stock reactions hinge on program updates, dose-selection data, and external validation (e.g., KOL commentary, conference data) rather than quarterly P&L prints .
- Near-term watch items: SSc enrollment start/pace; PSC site activation and interim safety gating; additional biomarker data disclosures that support patient stratification .
Sources: FY 2022 8-K and audited financials/MD&A ; Phase 2a NASH topline 8-K/press release ; FDA IND clearance for SSc 8-K/press release ; Q2 and Q3 2022 earnings materials and call transcripts .