Sign in

You're signed outSign in or to get full access.

WT

Werewolf Therapeutics, Inc. (HOWL)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally strong: HOWL initiated dosing in the Phase 1b/2 WTX-330 trial, kept WTX-124 expansion arms actively enrolling, and reiterated plans to present interim WTX-124 data and meet the FDA in 2H 2025 .
  • Financially, net loss was $18.09M and EPS was $(0.40); revenue was $0 as Jazz collaboration revenue has substantially completed—EPS beat consensus by ~$0.03 while revenue missed modestly versus a $0.30M estimate .
  • Cash guidance improved: runway extended into 4Q 2026 (previously through at least 2Q 2026), reducing near-term financing risk amid upcoming data catalysts .
  • New pipeline expansion: management introduced proprietary INDUCER T cell engagers with a first development candidate targeted by end of Q2 2025, broadening modality reach and potential future partnering options .

What Went Well and What Went Wrong

What Went Well

  • WTX-330 progressed into Phase 1b/2 with first patient dosed, aiming to optimize exposure and build on encouraging first-in-human signals—speed of execution de-risks timelines .
  • WTX-124 continued to show clinically meaningful anti-tumor activity with tolerable safety; expansion arms are actively enrolling at 18 mg IV Q2W, supporting a potential best-in-class IL-2 profile .
  • Cash runway extended into 4Q 2026, increasing operational flexibility ahead of 2H 2025 regulatory interactions and interim data readouts .

Management quotes:

  • “We remain on track... to share interim data and meet with the FDA to discuss potential registrational pathways in the second half of this year.” — Daniel J. Hicklin, Ph.D., President and CEO .
  • “We recently initiated a Phase 1b/2 clinical trial of WTX-330 to explore antitumor activity and optimize the exposure... in the tumor microenvironment.” — Daniel J. Hicklin, Ph.D. .
  • “Our proprietary PREDATOR masking and targeting technology distinctly positions us to build a robust pipeline of T cell engagers...” — Daniel J. Hicklin, Ph.D. .

What Went Wrong

  • Revenue was $0 in Q1 2025 as Jazz collaboration revenue recognition ceased after performance obligations were substantially completed—driving reliance on cash and raising sensitivity to cost control .
  • Net loss increased year over year (Q1 2025: $18.09M vs. $16.19M in Q1 2024) given continued R&D investment in clinical programs .
  • No earnings call transcript available for Q1 2025, limiting visibility into real-time Q&A clarifications on regulatory strategy and trial enrollment pacing .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$16.67 $20.40 $18.09
EPS, Basic & Diluted ($USD)$(0.38) $(0.46) $(0.40)
Total Operating Expenses ($USD Millions)$17.12 $20.35 $17.99
R&D Expense ($USD Millions)$12.53 $15.73 $13.12
G&A Expense ($USD Millions)$4.60 $4.62 $4.87
Cash & Cash Equivalents ($USD Millions)$122.83 $110.99 $92.04
Working Capital ($USD Millions)$113.37 $97.89 $82.79

Performance vs Consensus (Q1 2025):

MetricActualConsensusSurprise
EPS ($USD)$(0.40) $(0.4333)*+$0.0333 (beat)*
Revenue ($USD Millions)$0.00 $0.30*-$0.30 (miss)*

Values marked with * retrieved from S&P Global.

Notes:

  • Collaboration revenue was zero in Q1 and Q4 2024 as performance obligations under the Jazz agreement were substantially completed in mid-2024 .
  • With $92.0M cash at 3/31/25 and updated runway into 4Q 2026, liquidity appears sufficient for planned milestones .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearThrough at least 2Q 2026 Into 4Q 2026 Raised
WTX-124 Interim Data (Mono + Combo)2025Monotherapy & combo interim data in 4Q 2025 Present interim data during 2H 2025 Timing window broadened (earlier/2H)
WTX-124 FDA Interactions2H 2025Plan to meet FDA in 2H 2025 Engage regulators in 2H 2025 Maintained
WTX-330 Trial InitiationQ1 2025On track to initiate by end of Q1 2025 Phase 1b/2 dosing initiated Achieved
WTX-124 Expansion Arms2025Full enrollment targets set for 2025 (melanoma mono 1H; combo YE) All expansion arms actively enrolling at 18 mg IV Q2W Progressing

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available; themes derived from press releases and investor materials.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Regulatory/Registrational Path for WTX-124Planning for FDA meetings in 2H 2025; expansion data to inform registrational strategies On track to present interim data and engage FDA in 2H 2025 Consistent; timeline reiterated
R&D Execution (WTX-124)RDE selected; continued monotherapy/combo activity; expansion arms opened All expansion arms actively enrolling; ongoing anti-tumor activity Positive execution momentum
R&D Execution (WTX-330)Interim activity/tolerability; on track to start Phase 1/2 by end Q1 2025 Phase 1b/2 initiated; regimen optimization focus Milestone achieved; optimization phase
Pipeline Expansion (INDUCER TCEs)Platform breadth highlighted; preclinical progress INDUCER TCE development candidate targeted by end Q2 2025 New near-term candidate
Cash RunwayThrough at least 2Q 2026 Extended into 4Q 2026 Improved
Patient/Clinical NarrativeClinically meaningful responses in refractory settings Patient story: CSCC complete response sustained >1 year off therapy in WTX-124 program (external center) Reinforced clinical credibility

Management Commentary

  • Strategic emphasis: advancing WTX-124 toward potential registrational discussions based on interim data in 2H 2025 while broadening the platform into INDUCER T cell engagers .
  • Quote: “We remain on track... to share interim data and meet with the FDA to discuss potential registrational pathways in the second half of this year.” — Daniel J. Hicklin, Ph.D. .
  • Quote: “We recently initiated a Phase 1b/2 clinical trial of WTX-330...” — Daniel J. Hicklin, Ph.D. .
  • Platform positioning: “PREDATOR masking... positions us to build a robust pipeline of T cell engagers with potentially best-in-class potency and safety profiles...” — Daniel J. Hicklin, Ph.D. .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available in the document catalog; no Q&A highlights to report .
  • Investor-facing materials (Exhibit 99.2 corporate deck) covered clinical design details, PK findings, and trial strategy, partially substituting for typical call clarifications .

Estimates Context

  • EPS beat: Actual $(0.40) vs consensus $(0.4333), +$0.0333 surprise; indicates disciplined OpEx and absence of non-recurring charges in the quarter relative to expectations *.
  • Revenue miss: Actual $0 vs consensus $0.30M; consistent with prior disclosure that Jazz collaboration revenue largely ceased after mid-2024 performance completion *.
  • Forward consensus leans to continued negative EPS while revenue near zero given development-stage status (limited/no collaboration inflows) [GetEstimates forward periods]*.

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts: interim WTX-124 data and FDA engagement in 2H 2025; WTX-330 regimen optimization in Phase 1b/2 with multiple expansion indications—key stock reaction drivers over the next 6–9 months .
  • Liquidity improved: runway into 4Q 2026 reduces financing overhang through pivotal strategic inflections (data/FDA interactions) .
  • Clinical validation narrative strengthening: durable responses across WTX-124 mono/combo and encouraging WTX-330 signals support platform differentiation; patient case reports reinforce mechanism and tolerability .
  • Execution momentum: first patient dosed in WTX-330 Phase 1b/2 and active enrollment across WTX-124 arms at RDE (18 mg IV Q2W) demonstrate operational cadence .
  • Pipeline breadth: INDUCER T cell engager candidate targeted by end Q2 2025 expands addressable opportunities and potential BD optionality .
  • Estimate recalibration: consensus may adjust to slightly better EPS trajectory given cost controls; revenue remains negligible unless new BD/collaboration inflows emerge * *.
  • Trading lens: Data timing and FDA dialogue represent primary narrative drivers; improved runway dampens near-term dilution risk and may increase sensitivity to positive clinical disclosures .

Additional Data and KPIs

WTX-124 Program Status and Dosing

  • All expansion arms actively enrolling at 18 mg IV Q2W; plan to present interim data (mono + combo) and engage FDA in 2H 2025 .

WTX-330 Program Status

  • Phase 1b/2 initiated (WTX-330x2102); step-up/fixed dose finding to optimize exposure, with planned expansion arms in melanoma, MSS-CRC, and NHL .

Preclinical/Platform Expansion

  • INDUCER T cell engagers: anti-CD3 masking and tumor-protease linkers aim to reduce CRS and improve therapeutic index; first development candidate anticipated by end Q2 2025 .

Community/Patient Spotlight

  • External clinical site case: CSCC patient achieved undetectable disease sustained >1 year after enrollment in an IL-2 prodrug study; underscores potential of conditionally activated cytokine therapies .

All citations refer to primary documents:

  • Q1 2025 press release and 8-K:
  • Q4 2024 press release and 8-K:
  • Q3 2024 press release and 8-K:
  • Additional Q1 2025 period press releases:

Values marked with * retrieved from S&P Global.