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Indaptus Therapeutics, Inc. (INDP)·Q3 2025 Earnings Summary

Executive Summary

  • Indaptus reported no revenue and a narrower quarterly net loss of $2.98M, driven by lower operating expenses; diluted EPS of -$2.98 beat the Wall Street consensus of -$4.17, an upside of $1.19 per share, aided by disciplined OpEx management and reduced G&A versus last year .
  • Clinical update: Safety Lead-In cohort in the Decoy20 + tislelizumab combination showed tolerability at current dose/schedule; efficacy mixed (3 stable disease, 3 progressions), with enrollment paused pending additional efficacy evaluations and assessment of next development options .
  • Liquidity improved sequentially versus Q1 and supported by financing activities (SEPA, June convertible notes, September ATM), with cash/equivalents of $5.83M and runway guided into Q1 2026, up from Q2 guidance into Q4 2025 .
  • Operational focus shifted to the combination study (Decoy20 + PD‑1), with cost controls implemented since May; management highlighted tolerance data as a potential catalyst pending further efficacy readouts by year-end .

What Went Well and What Went Wrong

What Went Well

  • Tolerability confirmed in Safety Lead-In of Decoy20 + tislelizumab; Safety Review Committee judged the combo “appears to be tolerable at the current dose and schedule,” positioning for potential progression upon efficacy clarity .
  • Cost discipline and mix changes reduced OpEx: G&A down ~$0.55M YoY; total quarterly operating expenses fell to $2.65M from $3.14M YoY, improving EPS versus consensus and prior periods .
  • Financing optionality preserved and executed: ~$2.34M raised via ATM in September; conversion of $5.7M notes to equity and warrants in July; SEPA access ($20M capacity) with ~$1.75M net proceeds YTD .
    • CEO: “We remain focused on disciplined execution and look forward to sharing more data from our combination trial by the end of the year.”

What Went Wrong

  • Mixed efficacy signals in combo: among six evaluable patients, three progressed and three showed stable disease, leading to a pause in enrollment for further efficacy assessment—introducing timeline uncertainty for full enrollment .
  • Other income declined with lower average cash balances; fair value changes on the convertible notes added to reported losses in the period .
  • Going concern disclosures remain: substantial doubt flagged; while runway guided into Q1 2026, additional capital is required to sustain development beyond that horizon .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD)$0.00 $0.00 $0.00 $0.00
Net Loss ($USD Millions)$(3.069) $(4.532) $(5.229) $(2.975)
Diluted EPS ($)$(9.04)*$(9.00)*$(9.09)*$(2.98)*
Total Operating Expenses ($USD Millions)$3.142 $4.573 $4.457 $2.648
Cash and Equivalents ($USD Millions)$7.381 $3.891 $6.158 $5.826

Values with asterisk retrieved from S&P Global.

Estimate comparison (Q3 2025):

  • EPS: Actual $(2.98)* vs Consensus $(4.17) → Surprise +$1.19 per share; beat, driven by lower OpEx and reduced G&A YoY .
  • Revenue: Actual $0.00 vs Consensus $0.00 → In line.
    Values retrieved from S&P Global.

Segment breakdown:

  • Single segment (R&D-focused immunotherapy); no product revenue recognized .

KPIs:

KPI ($USD)Q3 2024Q1 2025Q2 2025Q3 2025
R&D Expense (Quarter)$1.466M $2.811M $2.167M $1.518M
G&A Expense (Quarter)$1.676M $1.762M $2.290M $1.131M
Other Income (Quarter)$0.073M $0.040M $0.016M $0.039M
Fair Value Change on Notes (Quarter)$0.000M $0.000M $(0.788)M $(0.366)M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperating activities coverageInto Q4 2025 (as of Q2) Into Q1 2026 (as of Q3) Raised runway
Combination Study EnrollmentNear-term planInitiated Safety Lead-In cohort in Q2 Paused enrollment pending efficacy evaluations and assessment of next options Paused
Financing Strategy2025SEPA in place; June 2025 notes; ATM available Continued use of ATM (Sept $2.34M gross), SEPA utilization; notes converted to equity/warrants Maintained/accessed facilities

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Clinical strategy pivot to comboQ1: Initiated expansion arm planning for Decoy20 + tislelizumab; cost focus Safety Lead-In completed; tolerability confirmed; enrollment paused pending efficacy review From initiation to safety readout; awaiting efficacy clarity
Safety/tolerability (CRS, transient AEs)Q1/Q2: Weekly dosing well-tolerated; CRS events resolved; transient biomarker induction Combo deemed tolerable at dose/schedule by Safety Review Committee Stable tolerability; combo acceptable
Financing/liquidityQ1/Q2: SEPA, January equity/warrants, June notes Sept ATM raise (~$2.34M); cash guided into Q1 2026 Improved runway; active financing toolkit
Cost disciplineQ1: Cost-reduction plan initiated; focus on combo Lower G&A YoY; OpEx down YoY Continued discipline supports EPS beat
Regulatory/legalRoutine disclosures; risk factors maintained Going concern risk reiterated; no material legal proceedings Risk profile unchanged; focus on financing

Note: No earnings call transcript was filed for Q3 2025; themes derived from 8‑K/press releases/10‑Q.

Management Commentary

  • CEO perspective: “We have completed the Safety Lead-In cohort... the Decoy20 and tislelizumab combination appears to be tolerable... we have paused enrollment pending additional efficacy evaluations... We remain focused on disciplined execution and look forward to sharing more data from our combination trial by the end of the year.”
  • Clinical observations: “Of the first three evaluable patients, one patient had stable disease at the first assessment, and the other two patients had disease progression. We continue to dose additional patients and will report their results in the coming weeks.” — Dr. Roger Waltzman, CMO
  • Financing emphasis: “We raised total gross proceeds of approximately $2.3 million through our at-the-market facility... further strengthening our balance sheet.” — CEO

Q&A Highlights

  • Not applicable; no Q3 2025 earnings call transcript was filed. Commentary and clarifications are drawn from SEC filings and press releases .

Estimates Context

  • Q3 2025 EPS: Actual $(2.98)* vs S&P Global consensus $(4.17) → beat by $1.19; coverage limited (1 estimate), suggesting low analyst depth and higher variance potential.
  • Q3 2025 Revenue: Actual $0.00 vs consensus $0.00 → in line; pre-revenue biotech profile maintained.
  • Target price consensus: $10.0; recommendation text unavailable; minimal coverage depth this quarter.
    Values retrieved from S&P Global.

Key Takeaways for Investors

  • EPS beat underscores effective OpEx control and lower G&A YoY; near-term trading may react to further efficacy data from the combo study by year-end as a catalyst .
  • Clinical risk remains elevated: mixed combo efficacy (stable disease vs progressions) and enrollment pause introduce timeline uncertainty; watch for efficacy updates and Safety Review Committee decisions .
  • Liquidity extended into Q1 2026 with active financing (ATM, SEPA, notes conversion); expect continued use of capital markets—dilution risk persists but mitigates near-term going concern pressure .
  • Pre-revenue, single-segment R&D model means valuation is driven by clinical milestones; robust safety/tolerability plus any efficacy signal improvement could re-rate sentiment .
  • Monitoring items: combo efficacy at next assessments, financing cadence/terms, OpEx trajectory, and any strategic partnering to defray trial costs .
  • Near-term stance: event-driven—position sizing should reflect data-readout risk and limited analyst coverage (1 estimate), which can amplify price moves on new information.
  • Medium-term thesis: if Decoy20 demonstrates durable efficacy signals in combination with PD‑1, the platform’s immunologic mechanism and tolerability profile could support progression into later-stage trials; financing and dilution management will be key .
Sources:
- Q3 2025 8‑K and press release: **[1857044_0001493152-25-021758_ex99-1.htm:0]** **[1857044_0001493152-25-021758_ex99-1.htm:6]** **[1857044_0001493152-25-021758_ex99-1.htm:1]** **[1857044_0001493152-25-021758_form8-k.htm:1]** **[1857044_a9072d47b730488b8724d076a75b1d6c_0]** **[1857044_a9072d47b730488b8724d076a75b1d6c_1]** **[1857044_a9072d47b730488b8724d076a75b1d6c_2]** **[1857044_a9072d47b730488b8724d076a75b1d6c_6]** **[1857044_a9072d47b730488b8724d076a75b1d6c_7]**
- Q3 2025 10‑Q: **[1857044_0001493152-25-021759_form10-q.htm:6]** **[1857044_0001493152-25-021759_form10-q.htm:8]** **[1857044_0001493152-25-021759_form10-q.htm:9]** **[1857044_0001493152-25-021759_form10-q.htm:17]** **[1857044_0001493152-25-021759_form10-q.htm:20]** **[1857044_0001493152-25-021759_form10-q.htm:22]** **[1857044_0001493152-25-021759_form10-q.htm:24]** **[1857044_0001493152-25-021759_form10-q.htm:27]** **[1857044_0001493152-25-021759_form10-q.htm:29]** **[1857044_0001493152-25-021759_form10-q.htm:34]**
- Q2 2025 8‑K/press release: **[1857044_0001641172-25-023332_ex99-1.htm:0]** **[1857044_0001641172-25-023332_ex99-1.htm:6]** **[1857044_10d2de3aa1084bc6bacca6647c45763c_1]** **[1857044_10d2de3aa1084bc6bacca6647c45763c_6]** **[1857044_10d2de3aa1084bc6bacca6647c45763c_7]**
- Q1 2025 8‑K/press release: **[1857044_0001641172-25-010098_ex99-1.htm:0]** **[1857044_0001641172-25-010098_ex99-1.htm:5]** **[1857044_ca505134f71e4626972e28b7d5fcff6e_0]** **[1857044_ca505134f71e4626972e28b7d5fcff6e_5]**
- Clinical update (Sept 4, 2025): **[1857044_5029d87726c54954b547c752c1c69f84_0]**

Values with asterisk retrieved from S&P Global.