Sign in

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

IT

iTeos Therapeutics, Inc. (ITOS)·Q1 2021 Earnings Summary

Executive Summary

  • Clinical execution on track with expansion of pipeline activities; Q1 highlighted six active studies across TIGIT antibody EOS-448 and A2A antagonist inupadenant, with additional ASCO and mid-2021 combination readouts ahead .
  • Operating expenses rose as planned on R&D scale-up (R&D $11.6M, +$5.8M YoY; G&A $7.0M, +$4.6M YoY) and public company costs; net loss was $13.5M or $0.39 per share as the company remains pre-revenue .
  • Liquidity remains strong with $321.4M cash/equivalents and runway into 2023, supporting multiple clinical trials and discovery efforts .
  • Near-term catalysts: ASCO monotherapy-biomarker update for inupadenant (June 4–8) and initiation of EOS-448 combinations (pembro, inupadenant, IMiD) in mid-2021; these data points and clinical initiations are likely to drive stock narrative and estimate revisions in the sector despite lack of formal revenue/EPS estimates for ITOS .

What Went Well and What Went Wrong

What Went Well

  • TIGIT program momentum: EOS-448 Phase 1 monotherapy showed a confirmed partial response in a pembrolizumab-refractory melanoma patient and robust peripheral biomarker activity (TIGIT+ Treg depletion; reduced exhausted CD8 T-cells), supporting FcγR engagement and the move into combination cohorts mid-2021 .
  • Inupadenant biomarker progress: Updated monotherapy data slated for ASCO indicate a potential association between intratumoral A2A receptor expression and clinical benefit, a potentially differentiating biomarker approach among A2AR antagonists .
  • Balance sheet resilience: $321.4M in cash/equivalents and reiterated runway into 2023 provide flexibility to pursue multiple combination strategies and a discovery pipeline candidate nomination before year-end 2021 .

Quotes:

  • “Our current clinical strategy includes six studies for our two clinical programs… expected to provide meaningful readouts before the end of 2022.” — Michel Detheux, CEO .
  • “These robust biomarker data… indicate that EOS-448 is highly active with strong on target immune responses and may potentially drive even stronger responses in combination studies.” — Joanne (Joe) Lager, CMO .

What Went Wrong

  • No topline clinical efficacy expansions yet disclosed beyond dose escalation anecdotes; key validation events remain ahead (ASCO, combination initiations), sustaining execution risk typical for early-stage IO .
  • Operating spend stepped up materially as trials expand (R&D $11.6M vs $5.8M YoY; G&A $7.0M vs $2.4M YoY), increasing quarterly burn despite strong cash reserves .
  • Consensus estimate benchmarking unavailable: S&P Global consensus data was not accessible for ITOS this quarter via our connection, limiting traditional beat/miss framing and potentially tempering near-term trader interest in a numbers-driven setup (S&P Global consensus unavailable).

Financial Results

MetricQ3 2020Q4 2020Q1 2021
Cash and Cash Equivalents ($M)$340.0 $336.3 $321.4
Research & Development Expense ($M)$8.7 $9.2 $11.6
General & Administrative Expense ($M)$4.8 $5.7 $7.0
Net Loss ($M)$11.7 $14.9 $13.5
Diluted EPS ($)-$0.48 -$0.43 -$0.39

Notes:

  • The company did not disclose revenue for Q3 2020, Q4 2020, or Q1 2021 in these press releases; ITOS remains a clinical-stage biotech without commercial products, and margins are not applicable in this stage .
  • YoY drivers (Q1 2021): R&D increase primarily due to higher activity in clinical trials for inupadenant and EOS-448 and headcount; G&A increase driven by headcount and public company costs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate“Into second half of 2023” (as of 12/31/20) “Runway into 2023” (as of 3/31/21) Maintained (slightly narrowed phrasing)
EOS-448 Combo Trial Starts2021Begin mid-2021 (pembro, inupadenant, other combos) Advance into combo trials mid-2021 (pembro, inupadenant; IMiD in myeloma) Maintained
Inupadenant Monotherapy Update2021Updated single-agent and initial pembro combo later in 2021 Monotherapy biomarker update at ASCO, June 4–8, 2021 Timing specified (near-term)
Pipeline: New Candidate Nomination2021Nominate additional candidate before YE 2021 Nominate additional product candidate before YE 2021 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3’20 and Q4’20)Current Period (Q1’21)Trend
TIGIT (EOS-448) clinical profileInitial data anticipated 1H21; FcγR engagement intended; dose escalation ongoing First-in-human monotherapy data show PR in pembrolizumab-refractory melanoma; TIGIT+ Treg depletion and reduced exhausted CD8+; combinations starting mid-2021 Improving validation; moving to combinations
A2A (inupadenant) biomarkerExpansion and updated single-agent/initial pembro combo later in 2021 ASCO update to show association of A2A receptor expression with outcomes; selective A2AR profile emphasized Clearer biomarker thesis
Combination strategyEOS-850 + pembro; +chemo TNBC; EOS-448 combos planned post-dose escalation EOS-448 + pembro (NSCLC, HNSCC), +inupadenant, +IMiD (myeloma); inupadenant + pembro and +chemo cohorts ongoing Broader and targeted
Indication focusSignal-seeking in melanoma, CRPC, TNBC; TIGIT in solid tumors Considering gastric, pancreatic; prioritizing 1L NSCLC and HNSCC; post-PD-1 melanoma for combos Expanding indications
Corporate runwayStrong cash post-IPO; runway into 2023/2H23 $321.4M cash; runway into 2023 Maintained
New formulationNot previously highlighted in PRsNew salt formulation for inupadenant entering Phase 1 in coming months Incremental CMC progress

Management Commentary

  • Strategic posture: “Our current clinical strategy includes six studies… expected to provide meaningful readouts before the end of 2022.” — Michel Detheux, CEO .
  • Inupadenant biomarker: “We think that there is a potential correlation between the expression… of the A2A receptor in the tumors and the clinical outcomes of patients.” — Joanne (Joe) Lager, CMO .
  • EOS-448 mechanism: “Our peripheral biomarker data demonstrated TIGIT positive Treg depletion and a reduction in exhausted TIGIT positive CD8 T-cells… [indicating] strong on target immune responses.” — Joanne (Joe) Lager, CMO .
  • Capital position: “We are well capitalized with a runway well into 2023.” — Michel Detheux, CEO ; cash/equivalents $321.4M at 3/31/21 .

Q&A Highlights

  • Near-term data cadence: ASCO update will include monotherapy expansion cohorts (melanoma, prostate, lung, endometrial; six patients each) and >20 biomarker biopsies; deeper biomarker detail likely later in 2021 (potential SITC) .
  • Indication expansion: Considering gastric and pancreatic cancers; prioritizing 1L NSCLC and HNSCC for TIGIT+pembro; interest in post-PD-1 melanoma; rationale grounded in biology and competitor landscape .
  • Biomarker differentiation: Developed challenging A2A receptor IHC; believe correlation with outcomes is novel; assay and selectivity may confer competitive advantage .
  • CMC/formulation: New salt formulation for inupadenant may improve dissolution; Phase 1 start anticipated in coming months .
  • CRPC strategy: Monotherapy helps define MOA and patient selection; pembro combination offers chemo-free approach and potential differentiation vs triplets .

Estimates Context

  • Wall Street consensus via S&P Global for ITOS Q1 2021 was unavailable in our connection at this time; as a result, we do not present revenue/EPS beat/miss comparisons this quarter. We attempted to retrieve S&P Global consensus but could not access a company mapping for ITOS; estimate comparisons are therefore not shown (S&P Global data unavailable).

Key Takeaways for Investors

  • TIGIT (EOS-448) advancing with supportive biomarker and monotherapy signal; combination initiation mid-2021 is the next inflection to watch for efficacy and safety synergy with PD-1 and other backbones .
  • Inupadenant’s A2A receptor expression biomarker could be differentiating; ASCO readout is the near-term trading catalyst and may guide patient selection and combo strategy .
  • Strong cash runway into 2023 supports multiple parallel studies without near-term financing pressure, enabling data-driven prioritization .
  • Expense growth is intentional as trials expand; monitor burn trajectory versus milestone cadence (e.g., ASCO data, combo starts, new candidate nomination) .
  • Indication strategy is broadening (NSCLC, HNSCC, melanoma, myeloma, plus potential gastric/pancreatic), increasing optionality but also execution complexity; partner discussions may accelerate programs over time .
  • Absence of consensus estimates/financial guidance limits classic beat/miss trading setups; stock likely to trade on clinical readouts and partnership signals rather than quarterly P&L .

Supporting Sources:

  • Q1 2021 8-K/Press Release and Business Update: cash, OpEx, net loss/EPS, clinical updates, upcoming ASCO and combination plans .
  • Q1 2021 Earnings Call Transcript: strategy, biomarker and mechanism details, indications, Q&A on data timing, formulation, and competitive positioning .
  • Prior Quarters for Trend Analysis: Q3 2020 and Q4 2020 press releases (cash, OpEx, net loss/EPS; pipeline timelines) .