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Keros Therapeutics, Inc. (KROS)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 revenue rose to $3.04M on a one-time license milestone (Hansoh), while net loss was $(46.0)M and EPS $(1.14); R&D spending moderated sequentially vs Q3 as programs progressed .
  • Liquidity strengthened: year-end cash was $559.9M, and the $200M Takeda upfront received in Feb-2025 extends cash runway into 2029, supporting continued advancement of KER-065 and cibotercept while Takeda funds elritercept ex‑China .
  • Program updates were mixed: elritercept advanced via Takeda partnership and positive ASH datasets, but the PAH Phase 2 TROPOS trial halted dosing in higher-dose arms after pericardial effusions; topline is still expected in Q2 2025 .
  • Near-term catalysts: KER-065 Phase 1 initial data in Q1 2025; TROPOS topline in Q2 2025 and subsequent strategic decision for cibotercept—key stock drivers over the next two quarters .

What Went Well and What Went Wrong

  • What Went Well

    • Strategic de-risking and capital infusion: exclusive global license with Takeda for elritercept with $200M upfront, milestones potentially >$1.1B, and tiered royalties; “We are thrilled to announce this agreement with Takeda…” (CEO) .
    • Compelling elritercept clinical signals: at ASH, durable transfusion independence in lower-risk MDS (median 134.1 weeks) and multi-lineage improvements; in MF, anemia improvements and reductions in spleen volume/symptoms support broader clinical benefit .
    • Cash runway extended into 2029 (post-Takeda payment), providing multi-year funding for KER-065 and cibotercept; CEO reiterated continued advancement and upcoming data timing .

  • What Went Wrong

    • TROPOS safety signal: voluntary halt of dosing in 3.0 and 4.5 mg/kg arms due to pericardial effusions; only 1.5 mg/kg arm continues; company notified FDA and expects topline in Q2 2025 .
    • Higher operating intensity year over year: Q4 net loss increased vs Q4 2023 (to $(46.0)M) driven by R&D and G&A to support pipeline and organization growth .
    • Limited recurring revenue: Q4 revenue spike to $3.04M was primarily a milestone under the Hansoh license; core operations remain pre-commercial with reliance on financing/partnering .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total Revenue ($USD Millions)$0.037 $0.388 $3.042
Service and Other Revenue ($USD Millions)$0.037 $0.388 $0.042
License Revenue ($USD Millions)——$3.000
R&D Expense ($USD Millions)$40.515 $49.225 $45.631
G&A Expense ($USD Millions)$9.961 $9.820 $10.665
Operating Loss ($USD Millions)$(50.439) $(58.657) $(53.254)
Dividend Income ($USD Millions)$5.378 $5.793 $6.519
Other Income (Expense), net ($USD Millions)$(0.196) $(0.092) $(0.229)
Net Loss ($USD Millions)$(45.257) $(52.956) $(46.026)
EPS, Basic & Diluted ($)$(1.25) $(1.41) $(1.14)
Weighted Avg. Shares (Millions)36.103 37.591 40.338
Cash & Cash Equivalents ($USD Millions, period-end)$405.863 $530.684 $559.931

Notes:

  • Q4 revenue includes a $3.0M license milestone (Hansoh). QoQ revenue increase largely reflects this item .
  • No segment reporting; company is pre-commercial .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q3 2024Into Q3 2027 Into 2029, inclusive of $200M Takeda upfront received Feb-2025 Raised
KER-065 (Phase 1 HV) Initial DataNear-term“First quarter of 2025” reiterated from earlier plans Q1 2025 (unchanged) Maintained
TROPOS (KER-012 in PAH) ToplineNear-termEnrollment completed; data updates expected next 9 months (prior commentary) Topline from all arms in Q2 2025; higher-dose arms halted; 1.5 mg/kg continues Clarified timing/safety update
Elritercept (KER-050) Phase 3 RENEWStart of enrollment“Will begin enrollment soon” (pre-license) Takeda responsible globally ex‑China; enrollment to commence soon (unchanged) Maintained/partner-led

Earnings Call Themes & Trends

Transcript for Q4 2024 earnings call was not available in our document set; themes below reflect company disclosures across Q2–Q4 period press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Capital & RunwayQ2: Cash $405.9M; runway into 2027 . Q3: ATM strengthened cash; runway into Q3 2027; cash $530.7M .YE cash $559.9M; $200M Takeda upfront in Feb-2025 extends runway into 2029 .Improving liquidity/duration
Strategic PartneringNo major partner update in Q2; focus on pipeline .Exclusive global license with Takeda for elritercept; milestones >$1.1B potential .Positive de-risking
R&D Execution (Elritercept)Ongoing Phase 2 in MDS/MF; progress noted . Q3: set stage for data updates .ASH data: durable TI in MDS; MF improvements in anemia/spleen/symptoms .Strengthened dataset
R&D Execution (Cibotercept)Q3: TROPOS fully enrolled .Safety-driven halt in higher-dose arms due to pericardial effusions; topline Q2 2025 .Elevated risk/safety management
KER-065Q2–Q3: entering/advancing Phase 1; obesity/neuromuscular positioning .Q4: Initial Phase 1 HV data expected Q1 2025 .On track for readout
Regulatory/LegalNot highlighted in Q2–Q3 operational releases .Noted FDA notifications re TROPOS dosing changes .Active regulatory engagement

Management Commentary

  • “The efforts over the past year by the team at Keros have positioned us to continue to advance our promising pipeline… [we] are excited to report initial data from the ongoing Phase 1 clinical trial of KER-065 in healthy volunteers in the first quarter of 2025… We continue to expect to report data from the Phase 2 TROPOS trial… and we plan to evaluate the appropriate development strategy for cibotercept following that data readout.” — Jasbir S. Seehra, Ph.D., Chair and CEO .
  • “We are thrilled to announce this agreement with Takeda, a leader in the hematologic oncology treatment space… We believe this global license further validates Keros’ position as a leader in… TGF‑β….” — Jasbir S. Seehra, Ph.D., Chair and CEO .
  • “The data we presented at ASH supports the differentiated profile of elritercept in both MDS and MF.” — Jasbir S. Seehra, Ph.D., Chair and CEO .
  • “We are working diligently to gain a better understanding of these unanticipated [TROPOS] findings… patient safety is our top priority….” — Jasbir S. Seehra, Ph.D., Chair and CEO .

Q&A Highlights

  • Q4 2024 earnings call transcript was not available via our document sources; therefore, Q&A details and any in-call guidance clarifications could not be reviewed [ListDocuments returned no earnings-call-transcript].

Estimates Context

  • S&P Global (Capital IQ) consensus estimates for Q4 2024 could not be retrieved at this time due to vendor rate limits; as a result, we cannot present a vs-consensus comparison for revenue or EPS. Values retrieved from S&P Global were unavailable at time of request.

Key Takeaways for Investors

  • Balance sheet and strategy de-risked by Takeda partnership: $200M upfront and potential milestones/royalties extend cash runway into 2029 and externalize elritercept development costs ex‑China .
  • Elritercept clinical momentum continues (MDS and MF datasets), supporting Phase 3 initiation (RENEW) and a clearer regulatory path under Takeda stewardship .
  • TROPOS safety event is the principal overhang near term; dose-dependent safety differentiation and Q2 2025 topline will be pivotal for cibotercept’s path forward .
  • Q4 revenue upside was non-recurring (license milestone), with the P&L otherwise reflecting expected pre-commercial R&D intensity; monitor spending trajectory vs milestone cadence .
  • Near-term catalysts: KER-065 Phase 1 data (Q1 2025) and TROPOS topline (Q2 2025) could reset the narrative; position sizing should reflect binary outcomes risk around TROPOS .
  • With extended runway and partner support, optionality improves around portfolio focus and capital allocation, especially pending TROPOS outcomes .

Supporting documents and data:

  • Q4 2024 8‑K 2.02 press release and financial statements .
  • Q3 2024 business update and financials .
  • Q2 2024 financial results .
  • Takeda license announcement (Dec 3, 2024) .
  • Elritercept ASH data (Dec 9–10, 2024) .
  • TROPOS safety update (Dec 12, 2024) .