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Ikena Oncology, Inc. (IKNA)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 delivered operating discipline with lower R&D spend (-22% YoY) and essentially flat net loss (-$17.3M vs -$17.3M YoY), while collaboration revenue dropped as expected given timing of BMS-partnered activities ($1.2M vs $6.4M YoY) .
  • IK-930 Phase 1 dose-escalation update showed a differentiated safety profile (minimal grade 1–2 proteinuria, one DLT due to reversible liver enzyme elevation) and signs of activity in EHE (7/7 stable disease; 3/7 tumor shrinkage), reinforcing the clinical thesis and near-term program decisions .
  • Liquidity strengthened by cash and investments of $196.9M at 9/30/23 and the Pionyr acquisition (~$43M net cash), supporting runway into 2026 and multiple data readouts (IK-930, IK-595) .
  • Near-term catalysts: IK-595 Phase 1 startup by YE 2023 and IK-930 clinical update (including EHE and initial mesothelioma) in 2H 2024; combination cohort with osimertinib planned in 2024 .

What Went Well and What Went Wrong

What Went Well

  • IK-930 safety/activity signal: selective TEAD1 inhibition showed minimal treatment-related proteinuria (3/26; grade 1–2, reversible; no dose reductions/interruptions) and disease control in all EHE patients evaluated; management emphasized circumventing renal toxicity seen with pan-TEADs. “IK-930 has thus far circumvented the renal toxicity observed with pan-TEAD inhibitors” – CEO Mark Manfredi .
  • Emerging efficacy in EHE: 7/7 stable disease, 3/7 tumor shrinkage; 4/7 reported symptomatic improvement; durations on treatment 18–26+ weeks in ongoing patients .
  • Balance sheet and runway: $196.9M in cash, equivalents and marketable securities, bolstered by ~$43M net cash from Pionyr; runway into 2026 to fund key readouts (IK-930, IK-595) .

What Went Wrong

  • Revenue decline: Collaboration revenue fell to $1.2M from $6.4M YoY, primarily due to completion of prior-period manufacturing efforts for IK-412 and program mix/timing under the BMS agreement .
  • R&D rebalancing headwind optics: While total R&D decreased YoY (-$4.2M), reductions were tied to winding down IK-175 activities and other discovery programs; investors may question breadth of pipeline progress until IK-595 is in clinic .
  • No earnings call transcript available: Limits external validation of tone and Q&A color around regulatory strategy, dose optimization, and combination plans (no earnings-call-transcript found) [ListDocuments earnings-call-transcript 2023-10/12: none].

Financial Results

MetricQ3 2022Q1 2023Q2 2023Q3 2023
Collaboration Revenue ($M)$6.402 $5.313 $2.004 $1.185
Research & Development Expense ($M)$18.850 $15.552 $15.172 $14.654
General & Administrative Expense ($M)$5.428 $5.276 $5.322 $6.034
Total Operating Expenses ($M)$24.278 $20.828 $20.494 $20.688
Net Loss ($M)$(17.338) $(14.219) $(17.115) $(17.343)
Diluted EPS$(0.48) $(0.39) $(0.44) $(0.40)
LiquidityQ3 2022Q1 2023Q2 2023Q3 2023
Cash & Cash Equivalents ($M)$59.919 (12/31/22) $29.329 (3/31/23) $70.868 (6/30/23) $121.277 (9/30/23)
Marketable Securities ($M)$97.028 (12/31/22) $108.484 (3/31/23) $86.444 (6/30/23) $75.656 (9/30/23)

Additional KPIs (quarter-only where available):

  • Net cash used in operating activities: $(19.9)M (Q3’23) vs $(17.2)M (Q3’22) .
  • Shares outstanding (weighted-average basic/diluted): 43.44M (Q3’23) vs 36.26M (Q3’22) .

Segment breakdown and margin metrics: Not applicable (no commercial product revenue; collaboration revenue only) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearInto 2026 (Q2 2023 10-Q) Into 2026 (Q3 2023 PR/8-K) Maintained
IK-930 Clinical Update2H 2024Initial data Q4 2023 expectation (earlier narrative); broader update timing evolving Additional IK-930 data in 2H 2024 (EHE and mesothelioma) Clarified timeline
IK-595 First-in-Human2023 StartIND 2H 2023 plan Clinical startup anticipated by YE 2023 Affirmed/Timed
Combination Cohort (IK-930 + Osimertinib)2024Collaboration with AZ to evaluate combo noted Combination cohort planned to initiate in 2024 New timing detail

No revenue, expense, operating income, tax, or dividend guidance provided .

Earnings Call Themes & Trends

(No public Q3’23 earnings call transcript identified; themes below reflect company disclosures across Q1–Q3 documents.)

TopicPrevious Mentions (Q1 & Q2 2023)Current Period (Q3 2023)Trend
IK-930 Hippo/TEAD1 safety/activityPhase 1 progressing; no DLTs as of Q1; monotherapy data expected Q4’23 Differentiated safety (limited grade 1–2 proteinuria), 1 DLT (reversible LFTs); EHE: 7/7 SD, 3/7 shrinkage; dose optimization ongoing Improving evidence; narrowing to targeted populations
IK-595 MEK-RAF molecular glueIND planned 2H’23 Clinical startup anticipated by YE 2023 Executing to clinic
BMS-collab IK-175/AHR & IK-412Enrollment completed; opt-in window to early 2024; IK-412 manufacturing delays noted historically Revenue down YoY due to prior IK-412 manufacturing completion; opt-in timing reiterated Neutral; wind-down of revenue recognition
Capital & runwayInto 2025 (Q1); extended to 2026 (Q2) Runway into 2026; Pionyr adds ~$43M net cash Strengthened
Corporate actionsMay 2023 equity raise; Pionyr deal closed Aug 2023 Pionyr cash consolidation; preferred converted in Oct 2023 Completed; balance sheet accretive

Management Commentary

  • “Even in the projected efficacious exposure range and at doses with clinical activity, IK-930 has thus far circumvented the renal toxicity observed with pan-TEAD inhibitors… we are increasing our focus on our targeted monotherapy indications, such as EHE and mesothelioma…” — Mark Manfredi, Ph.D., CEO .
  • “The EHE community is excited by this early data from IK-930, the first targeted agent for patients with EHE, and we eagerly await more data.” — Tammy Silverthorne, Executive Director, The EHE Foundation .
  • “Based on preclinical data indicating IK-930 synergy with EGFR inhibitors… a combination cohort for IK-930 and osimertinib in EGFR-mutant NSCLC is planned to initiate in 2024.” — Company statement .

Q&A Highlights

  • No Q3 2023 earnings call transcript was found in the company filings database; as such, no Q&A session highlights or analyst clarifications can be provided for this period (no earnings-call-transcript available) [ListDocuments earnings-call-transcript 2023-10/12: none].

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2023 revenue/EPS was unavailable due to missing S&P Global CIQ mapping for IKNA in the tool; therefore, we cannot assess beat/miss versus consensus for this quarter (attempted pull failed) [SpgiEstimatesError].
  • Given collaboration revenue volatility and pre-commercial status, Street coverage may be limited; investors should anchor on liquidity runway, clinical milestones, and program execution timing .

Key Takeaways for Investors

  • IK-930’s early clinical signal (safety window with TEAD1 selectivity; disease control and shrinkage in EHE) de-risks target class concerns and supports focused monotherapy expansions in EHE/mesothelioma; upcoming 2H 2024 update is the major clinical catalyst .
  • Balance sheet is a differentiator: $196.9M cash/marketable securities at 9/30 plus ~$43M from Pionyr supports runway into 2026 across two clinical programs (IK-930, IK-595), lowering near-term financing risk .
  • Revenue is not an indicator of progress here; the YoY decline reflects BMS-collaboration accounting timing (IK-412 manufacturing completion in prior period), not commercial performance .
  • Near-term execution bar: start IK-595 Phase 1 by YE 2023 and finalize IK-930 dose optimization; a combination cohort with osimertinib in 2024 adds optionality to the resistance-prevention thesis in EGFR-mutant NSCLC .
  • Risk balance: clinical-stage oncology risks (dose/formulation optimization, heterogeneous PK, small rare-disease cohorts) and partnership option timing (BMS opt-in) remain; however, selectivity profile and patient-directed strategy offer a clearer path to proof-of-concept .
  • Trading catalysts: any interim IK-930 updates (EHE durability, mesothelioma early signals), IK-595 FIH start and early safety/PK read-throughs, and any BMS option decisions could drive stock moves .

Supporting documents and data:

  • Q3 2023 8-K and Press Release with financial tables and pipeline update .
  • Q3 2023 10-Q for detailed financial statements and MD&A .
  • Q2 2023 10-Q trend data .
  • Q1 2023 10-Q baseline and runway reference .