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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)

MetricQ2 2022Q3 2022Q4 2022 (calc)Notes
Revenue$0.0 $0.0 $0.0 No product revenue
R&D Expense$2.9 $5.4 $5.9 (FY $16.98 − 9M $11.08) Derived from FY and 9M
G&A Expense$3.3 $2.9 $2.7 (FY $11.56 − 9M $8.81) Derived from FY and 9M
Net Loss$(6.2) $(8.1) $(8.3) (FY $27.65 − 9M $19.37) Derived from FY and 9M
EPS (Loss per Ordinary Share)$(0.027) $(0.035) n/aQ4 EPS not separately disclosed

Annual YoY comparison (USD Millions, unless noted)

MetricFY 2021FY 2022
Revenue$0.0 $0.0
R&D Expense$6.33 $16.98
G&A Expense$6.03 $11.56
Net Loss$(12.48) $(27.65)
EPS (Loss per Ordinary Share)$(0.060) $(0.121)

Liquidity snapshot (period-end, USD Millions)

MetricQ2 2022Q3 2022Q4 2022
Cash & Equivalents$9.88 $10.74 $13.52
Short-term Bank Deposits$41.84 $35.73 $26.37
Total Liquidity (Cash + ST Deposits)$51.72 $46.47 $39.89

Cash flow (FY 2022)

MetricFY 2022
Net Cash Used in Operating Activities$(20.37)
Net Cash Provided by (Used in) Investing Activities$19.53
Net Cash Provided by (Used in) Financing Activities$(0.81)

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

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThroughEnd of 2023 (as of Q3 commentary) At least through March 31, 2024 Raised/extended
PSC Phase 2 Topline Timing2H 2024 2H 2024 (unchanged) Maintained
PSC Dose StrategyOngoing10 mg/kg + plan for 5/20 mg/kg Focus on 10 and 20 mg/kg; low dose dropped given prior data Refined/focused
PSC Trial DesignOngoingDose-finding + OLE planned Dose-finding + OLE implemented/expanding sites Executing expansion
SSc Phase 2 Start1H 2023Plan to open by year-end 2022 FDA IND cleared; enrollment 1H 2023 On track with IND clearance

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2022)Previous Mentions (Q3 2022)Current Period (Q4 2022)Trend
PSC program (design, dosing, recruitment)Trial expansion planning; 5/10/20 mg/kg cohorts; OLE planned Continuing site add; interim safety analysis planned; topline 2H24 Focus on 10/20 mg/kg; low dose dropped; continued expansion Steady execution; dose focus
SSc program (proof of concept)Trial design under development; target biology rationale Finalized design; enrich by high CCL24; IND filing imminent FDA cleared IND; plan to enroll 1H23 Milestone achieved
Biomarker strategy/clinical activityECM/biomarker data presented; plan for NASH readout Biomarker activity in COVID lung injury study presented NASH Phase 2a met primary; multiple biomarker improvements Building validation
Cash runway & financingRunway through end 2023; ATM refreshed, no draw planned Runway through end 2023 reiterated Runway through Mar 31, 2024; funding needs still expected Slightly improved runway
Regulatory/legalVAT audit provision noted in 10-Q VAT assessments ~$1.046M; provision recorded Ongoing

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 .