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Chemomab Therapeutics Ltd. (CMMB)·Q2 2022 Earnings Summary

Executive Summary

  • Q2 2022 focused on advancing CM-101 across PSC, liver fibrosis (NASH), and systemic sclerosis, with regulatory filings to expand PSC, completion of the liver fibrosis treatment phase, and trial design progress in SSc; cash runway guided through end of 2023 .
  • Operating expenses rose year over year due to clinical ramp and non-cash items; net loss widened to $6.19M and loss per ordinary share to $0.027; cash and bank deposits were $51.8M vs. $57.5M in Q1 2022 .
  • Notable pipeline catalysts: PSC blinded interim safety review late 2022; PSC topline slated for 2H 2024; liver fibrosis topline planned before year-end 2022; SSc Phase 2 launch targeted by end of 2022 .
  • IP strengthened via a new U.S. method-of-use patent extending protection for CM-101 in hepatic diseases, with protection in U.S. to at least 2038 and additional extensions possible—supports long-term asset value .
  • Consensus estimates from S&P Global were unavailable; no beat/miss determination can be made for Q2 2022 (SPGI request limit exceeded; see Estimates Context).

What Went Well and What Went Wrong

What Went Well

  • Expanded PSC Phase 2 design filed with regulators to add dose-finding (5/10/20 mg/kg) and an open-label extension, enhancing the data package and dose selection for later-stage development .
  • Completed treatment phase for the randomized, placebo-controlled Phase 2 liver fibrosis trial in NASH (n=23; SC dosing 5 mg/kg every two weeks, 8 doses), positioning the program for a topline readout before year-end 2022 .
  • Strengthened IP via issuance of U.S. Patent No. 11365246 covering CM-101 in hepatic diseases; management emphasized its significance to CM-101 protections and therapeutic applicability: “This new patent adds to the protections…extends Chemomab intellectual property protections…through at least 2038” .

What Went Wrong

  • Operating expenses increased year over year as clinical programs ramped; R&D rose to $2.9M and G&A to $3.3M; net loss widened to $6.19M, driven in part by a non-cash equity-based compensation charge and a tax provision related to pre-merger transactions .
  • Cash and bank deposits declined sequentially to $51.8M from $57.5M as the company invested in clinical operations; management renewed ATM (cap ~$18M) but does not plan to draw—highlighting prudent capital stance amid sector volatility .
  • Consensus estimates were unavailable (SPGI limit), limiting external benchmark comparison for EPS/OpEx risk-management narratives and reducing ability to frame “beats/misses” (see Estimates Context).

Financial Results

P&L and EPS

MetricQ2 2021Q1 2022Q2 2022
R&D Expenses ($USD Millions)$1.31 $2.75 $2.91
G&A Expenses ($USD Millions)$1.45 $2.58 $3.34
Total Operating Expenses ($USD Millions)$2.75 $5.32 $6.25
Net Loss ($USD Millions)$2.77 $5.10 $6.19
Loss per Ordinary Share ($USD)$0.013 $0.022 $0.027

Notes:

  • Drivers of G&A increase included additions to senior team, non-cash equity compensation, and tax provision tied to pre-reverse merger activities .
  • Chemomab reports operating results without product revenue; margins not meaningful at this stage (see Statements of Operations showing operating expenses and net loss) .

Balance Sheet Liquidity

MetricQ4 2021Q1 2022Q2 2022
Cash, Cash Equivalents & Short-Term Bank Deposits ($USD Millions)$61.20 $57.50 $51.80
Cash & Cash Equivalents Only ($USD Millions)$14.69 $13.83 $9.88

Clinical Development KPIs

KPIQ1 2022Q2 2022
PSC Phase 2 DesignEnlarged trial with dose-finding; interim analysis late 2022 for safety/variability Finalized revisions; 3 dosing cohorts (5/10/20 mg/kg); 93 total patients (25 per dosing cohort; 18 placebo); primary outcome is safety; blinded interim safety review late 2022; topline 2H 2024
Liver Fibrosis (NASH) Phase 2Enrollment completed; final readout targeted near year-end 2022 Treatment phase concluded; 23 patients; active arm 5 mg/kg SC every 2 weeks × 8 doses; topline planned before year-end 2022
Systemic Sclerosis Phase 2Trial design focused on biological POC; launch by end of 2022 Significant design progress with KOLs; launch remains on track by end of 2022; special webcast planned
IP/Scientific ValidationSSc biomarker correlations and preclinical data presented at conferences New U.S. patent covering hepatic indications; multiple conference presentations highlighting CCL24 biology and CM-101 activity

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough end of 2023Runway through end of 2023 (updated last quarter) Runway through end of 2023 (unchanged) Maintained
PSC Phase 2 InterimLate 2022Interim analysis late 2022 (safety/variability) Blinded interim DMC safety review late 2022 Clarified (safety focus)
PSC Enrollment/Design2022–2024Dose-finding component added; expand sites 93 total patients; cohorts at 5/10/20 mg/kg; primary outcome safety; topline 2H 2024 Expanded scope; timeline defined
Liver Fibrosis (NASH) Topline2022Final readout near year-end 2022 Topline planned before year-end 2022 Maintained/affirmed
SSc Phase 2 Launch2022Launch by end of 2022 Launch by end of 2022; webcast to detail design Maintained
ATM FacilityOngoingRenewed ATM, reduced cap to ~$18M; no draw planned Renewed ATM (~$18M cap); no draw planned Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2021, Q1 2022)Current Period (Q2 2022)Trend
Clinical Strategy OptimizationRevisions to optimize CM-101 program; add PSC dose-finding; accelerate SSc POC PSC trial expansion finalized; SSc design progress with KOLs; liver fibrosis treatment phase completed Executing and advancing
Cash Runway & CapitalExtend runway through end of 2023; prudent OpEx, ATM reduced to ~$18M Runway reaffirmed; ATM renewed (~$18M), no draw planned Stable, conservative
Scientific ValidationPreclinical and clinical biomarker data in SSc; target engagement Multiple June conference presentations; ECM biomarker attenuation; PSC macrophage source of CCL24 Strengthening evidence
Regulatory/OperationalFDA IND for PSC site expansion; add sites in EU/US Global filings initiated; continued site openings in US and EU Scaling operations
IP PortfolioComposition of matter patents; global markets New U.S. method-of-use patent in hepatic diseases; protection to at least 2038 Expanded protection

Management Commentary

  • “We advanced our clinical programs for CM-101...added to our intellectual property portfolio...presented important new data...added several highly experienced staff...These are exciting times for our company” — Dale Pfost, CEO .
  • “We concluded the treatment phase of our Phase 2 Liver Fibrosis study...initiated global regulatory filings supporting expansion of our PSC Phase 2 trial...made significant progress on delineating the design of our upcoming Phase 2 trial in SSc” — Dale Pfost .
  • “We continue to prudently manage our cash and currently expect our runway to last through the end of 2023...renewed our existing ATM facility...cap of about $18 million...do not plan to draw” — Management .
  • “Treatment with CM-101 interfered with core PSC disease pathways in a way that is potentially associated with therapeutic activity” — Company on PSC preclinical model .
  • “CM-101 attenuates biomarkers associated with ECM expression...supports...translate findings...to similar serum biomarkers in patients” — Company on ECM data .

Q&A Highlights

  • Q2 2022 Q&A transcript content beyond introductory and prepared remarks was not retrievable due to a document retrieval inconsistency; highlights unavailable .
  • For context, Q1 2022 Q&A covered PSC interim focus (safety and biomarker variability), subcutaneous dosing convenience considerations, OpEx trajectory with PSC expansion and SSc start, and BD activity focus at BIO conference .

Estimates Context

  • S&P Global consensus for Q2 2022 EPS and revenue was unavailable due to request limits; no consensus vs. actual comparison can be provided at this time (SPGI daily limit exceeded) [GetEstimates error].
  • Given Chemomab’s pre-revenue profile and focus on clinical milestones, investor attention should center on OpEx, cash runway, and clinical catalysts rather than near-term revenue/EPS benchmarks .

Key Takeaways for Investors

  • PSC is the core value driver; expanded Phase 2 (93 patients; 3 dosing levels) and late-2022 blinded safety review de-risk dose selection ahead of topline in 2H 2024—watch for updates on enrollment pace and interim safety conclusions .
  • Liver fibrosis (NASH) Phase 2 topline before year-end 2022 provides first patient-level activity in established liver disease; positive signals would broaden platform credibility and support SC formulation .
  • SSc Phase 2 launch by end of 2022, with design aligned to biological POC across skin/lung/vascular endpoints; continued KOL engagement underpins endpoint selection integrity—anticipate webcast detailing final design .
  • Strengthened IP (method-of-use patent to at least 2038) and preclinical/biomarker data at major conferences bolster CM-101’s mechanistic rationale, aiding partnering optionality and long-term moat .
  • OpEx trending up with trial scale-up while cash runway through end of 2023 is reaffirmed; ATM renewed but no draw planned—supports disciplined capital strategy amid sector volatility .
  • Near-term trading catalysts: any PSC interim safety update late 2022, NASH topline at year-end, and SSc trial initiation news flow; these events can reset sentiment given absence of revenue/EPS beats/misses to anchor short-term moves .
  • Monitor G&A composition (non-cash stock comp; tax provision tied to pre-merger) and incremental site additions, which may impact quarterly OpEx variability; management remains focused on prudence .

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