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Chemomab Therapeutics Ltd. (CMMB)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 was an execution-heavy quarter: Chemomab advanced CM-101 across PSC, SSc, and liver fibrosis, while maintaining prudent cash management; cash, cash equivalents and bank deposits were $57.5M and net loss was $5.1M (−$0.02 per ordinary share) .
  • Clinical program revisions continued: PSC trial expansion (dose-finding cohorts, open-label extension) and an interim safety/variability analysis targeted for 2H22; SSc Phase 2 redesigned for earlier biological and clinical proof-of-concept with launch targeted by end of 2022 .
  • Operating expenses rose year over year as CM-101 programs ramped: R&D $2.7M vs $1.2M; G&A $2.6M vs $0.5M (including ~$0.9M non-cash stock-based comp), driving net loss to $5.1M vs $1.7M in Q1 2021 .
  • Near-term stock reaction catalysts: PSC interim safety/variability analysis in 2H22, SSc trial design details in August, and liver fibrosis study readout near year-end; management reiterated cash runway to end of 2023 and renewed but does not intend to draw the ~$18M ATM .

What Went Well and What Went Wrong

What Went Well

  • PSC program execution and scope expanded: added dose-finding cohorts (lower and higher doses), more sites across US/EU, and an open-label extension; interim analysis planned to support higher-dose progression and confirm cohort sizes. “We will be performing an interim analysis… expected late this year.” .
  • Liver fibrosis study completed enrollment early; final safety/PK/biomarker readout targeted for Q4 2022 to inform subcutaneous formulation next steps and mechanism-of-action validation .
  • Strengthened clinical operations: appointed Jack Lawler (20+ years global clinical ops) as VP of Global Clinical Development Operations, already adding US-based team members and improving trial execution .

What Went Wrong

  • OpEx escalated materially year over year: R&D rose to $2.7M (from $1.2M) and G&A to $2.6M (from $0.5M, including ~$0.9M SBC), lifting net loss to $5.1M (from $1.7M) .
  • SSc timeline push: previously guided to “early 2022” initiation, revised in Q4 2021 to 2H22 and now targeted “by the end of the year,” reflecting redesign for earlier proof-of-concept .
  • PSC interim readout will not include efficacy changes from baseline; management emphasized safety and variability assessment, which may temper near-term efficacy expectations .

Financial Results

MetricQ3 2021Q4 2021Q1 2022
Revenue ($USD Millions)$0.0 $0.0 $0.0
R&D Expenses ($USD Millions)$1.487 $2.383 $2.745
G&A Expenses ($USD Millions)$1.404 $2.641 $2.575
Total Operating Expenses ($USD Millions)$2.891 $5.024 $5.320
Net Loss ($USD Millions)$2.968 $5.036 $5.104
Diluted EPS - Continuing Operations ($USD per Ordinary Share)-$0.013 -$0.022 -$0.022
Cash + Short-term Bank Deposits ($USD Millions)$64.3 $61.2 $57.5

Notes:

  • Revenue is not reported; company remains pre-revenue, with statements of operations showing operating expenses and financing items only .
  • ADSs represent 20 ordinary shares; EPS figures reported per ordinary share .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough 2023Mid-2023 (Q3 2021) End-2023 (Q4 2021/Q1 2022) Raised/Extended
PSC Phase 2 interim analysis (10 mg/kg cohort)2H 2022Data 2H22 (Q3 2021) Interim safety/variability readout 2H22; supports higher-dose progression Maintained (scope clarified)
PSC dose cohorts2022–2023N/AAdd lower-dose cohort later 2022; open higher-dose cohort early 2023 New/Expanded
SSc Phase 2 initiation2022Early 2022 (Q3 2021) By end of 2022; redesigned for faster proof-of-concept Lowered/Delayed
ATM facilityOngoingPrior $75M cap Renewed at ~$18M; no plans to draw Reduced/Conservative stance

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q1 2022)Trend
Clinical strategy revisionQ4 2021: Strategic review to optimize CM-101; expand PSC trial; redesign SSc for earlier PoC; wind down liver fibrosis enrollment for focused objectives Execution underway: PSC sites expanded (US/EU), dose cohorts added, OLE added; SSc trial design progressing with KOLs; liver fibrosis enrollment completed Strengthening execution
PSC interim readout scopeQ3 2021: PSC data expected 2H22 Interim (2H22) will evaluate safety at 10 mg/kg and biomarker variability; no efficacy change-from-baseline at interim More precise expectations
SSc timelineQ3 2021: Early 2022 start ; Q4 2021: 2H22 Targeting end of 2022; design focuses on PoC across skin/lung/vascular Modest delay, clearer design
Subcutaneous formulationQ3 2021: SPLASH study to assess subcu PK/PD Enrollment complete; Q4 readout to inform subcu development On track
Cash management/runwayQ4 2021: Runway extended ~6 months to end-2023 Reiterated end-2023 runway; renewed ATM at ~$18M, no draw planned Conservative, stable
Business developmentN/APursuing partnering and potential in-licensing/acquisitions; follow-ups at BIO in June Active outreach

Management Commentary

  • “We are expanding our efforts in primary sclerosing cholangitis (PSC) with an enlarged clinical trial… adding an important dose finding component and an open-label extension… interim analysis… expected late this year.” — Dale Pfost, CEO .
  • “We expect the revised Phase 2 [SSc] trial design to enable an expedited path to proof-of-concept data… provide additional information on CM-101’s activity in modifying the skin, lung and vascular pathophysiology.” — Dale Pfost, CEO .
  • “Patient enrollment in [liver fibrosis] study is now complete and we are on target for a final data readout in the fourth quarter.” — David Weiner, Interim CMO .
  • “Cash, cash equivalents, and bank deposits were $57.5 million… We continue to prudently manage our cash and currently expect our runway to last through the end of 2023… renewed our existing ATM… ~$18 million… do not plan to draw.” — Don Marvin, CFO/COO .

Q&A Highlights

  • PSC interim analysis will focus on safety at 10 mg/kg and baseline variability in ALP and fibrosis biomarkers to validate cohort sizes; no efficacy change-from-baseline readout at interim .
  • SSc endpoints and design refinements are ongoing with KOLs; management plans significant detail on the next quarterly call in August .
  • Subcutaneous dosing: while IV would not be a barrier given unmet need, developing a viable subcu formulation remains important for patient convenience and broader indications .
  • OpEx outlook: expected to trend up through 2022 as PSC expands (US/Spain) and SSc kicks off in Q4 2022 .
  • BD focus: partnering discussions for CM-101 and potential pipeline expansion via licensing/acquisition; follow-ups at BIO (San Diego) in June .

Estimates Context

  • Wall Street consensus EPS and revenue estimates via S&P Global were not available for Q1 2022 at the time of this analysis; as a pre-revenue clinical-stage biotech with limited coverage, direct estimate comparisons are not included. As a result, there are no consensus-based beats/misses to report for Q1 2022.

Key Takeaways for Investors

  • Clinical execution is the core near-term driver: PSC interim safety/variability analysis in 2H22 and liver fibrosis readout in Q4 2022 will shape dose selection, endpoint strategy, and subcu pathway—key de-risking events .
  • SSc trial redesign prioritizes early proof-of-concept across multi-organ pathology; launch targeted by end-2022—clarity on endpoints/timing in August could reset expectations positively if scope is robust .
  • Balance sheet supports runway through end-2023; renewed ATM (~$18M) without intention to draw underscores disciplined capital posture amid challenging biotech markets .
  • OpEx is set to increase sequentially as trials scale—expect higher R&D through 2022; monitor cash burn versus milestones to validate runway and optionality .
  • Near-term share catalysts: PSC interim readout (safety/variability), August update on SSc design, Q4 liver fibrosis data; absence of interim efficacy in PSC suggests investors should focus on de-risking signals rather than immediate efficacy .
  • Strategic optionality via BD: ongoing dialogues for CM-101 partnering and possible asset in-licensing/acquisition could broaden the pipeline and funding avenues .
  • Net-net: With several data readouts and trial initiations pending, shares are sensitive to execution milestones and design disclosures; sustained cash discipline provides a bridge to these events .