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GT Biopharma, Inc. (GTBP)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered no revenue and a narrower net loss, with operating discipline offsetting higher SG&A; cash was $2.53M at quarter-end, with runway into Q1 2026 reiterated .
  • Clinical execution advanced GTB-3650 to Cohort 4 (10 µg/kg/day) with clean safety reviews through Cohort 3; next trial update guided to Q1 2026, pushing back from “later in 2025” commentary earlier in the year .
  • GTB-5550 IND timing was refined to late December 2025 or January 2026, a modest shift from prior Q4 2025 target; management framed platform advantages vs bispecifics, cell therapies and ADCs targeting B7H3 .
  • Against S&P Global consensus, EPS materially missed in Q3 2025 (actual −$0.83 vs −$0.38*), while revenue matched the $0 consensus; dilution risk rose as Greenshoe exercises cut conversion and warrant exercise prices and expanded warrant count .

What Went Well and What Went Wrong

What Went Well

  • Advanced GTB-3650 into Cohort 4 (10 µg/kg/day) after completing Cohort 3 safety review with no dose-limiting toxicities; six patients treated across Cohorts 1–3 with biomarker evidence of immune activation .
  • Management reaffirmed cash runway into Q1 2026, providing near-term funding clarity amid ongoing trials and IND preparation .
  • CEO highlighted the platform’s potential competitive advantage by bringing IL-15 to the immune synapse, suggesting differentiation versus bispecifics, cell therapies, and ADCs on B7H3: “The excellent safety profile… and the immune activation potential… suggests a potential competitive advantage for GTB-5550…” .

What Went Wrong

  • Q3 EPS missed consensus materially (−$0.83 actual vs −$0.38* estimate), despite year-over-year net loss improvement; SG&A rose vs prior year as stock comp increased .
  • Timelines slipped modestly: data update moved from “later in 2025” to Q1 2026; GTB-5550 IND window broadened to late Dec 2025/Jan 2026 .
  • Capital structure dilution intensified: Greenshoe exercises lowered conversion price to $0.6421 (and subsequently to $0.5319 post-quarter) and expanded warrant count via full-ratchet and anti-dilution protections, increasing overhang risk .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$(3.41) $(1.43) $(3.11)
Net Loss Per Share (EPS, $USD)$(1.53) $(0.55) $(0.83)
Operating ExpensesQ3 2024Q2 2025Q3 2025
R&D ($USD Millions)$1.31 $0.36 $0.63
SG&A ($USD Millions, incl. stock comp)$2.30 $1.15 $2.75
SG&A (Ex-Stock Comp) ($USD Millions)$2.3 $1.1 $2.4
Balance & CapitalQ3 2024Q2 2025Q3 2025
Cash & Equivalents ($USD Millions)—$5.23 $2.53
Warrant Liability ($USD Millions)—$0.24 $0.01
Weighted Avg. Shares (Basic/Diluted)2.23M 2.77M 3.94M
Shares Outstanding (Period End)—3.27M 6.05M
Common Shares Outstanding (Nov 6, 2025)——10.64M

Notes: SG&A ex-stock comp per press releases; SG&A including stock comp per 10-Q.

Segment breakdown: GT Biopharma reports one operating segment (clinical-stage immuno-oncology based on TriKE platform) .

KPIs:

  • GTB-3650 dose status: Cohort 4 initiated/planned at 10 µg/kg/day; protocol allows escalation to 25/50/100 µg/kg/day (Cohorts 5–7) if needed .
  • Patients: 14 planned (2 per cohort); six patients treated in Cohorts 1–3; two-week on/off cycles up to four months based on benefit .
  • GTB-5550 IND timing: late Dec 2025 or Jan 2026 .
  • Cash runway: into Q1 2026 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough Q1 2026“Sufficient into Q1 2026” (as of Q2) “Sufficient into Q1 2026” reiterated Maintained
GTB-3650 Trial UpdateData/Update Timing“More detailed results later in 2025” “Next update in Q1 2026” Lowered (timing pushed)
GTB-5550 IND SubmissionIND Timing“Q4 2025” “Late Dec 2025 or Jan 2026” Slightly Lowered/Refined

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available; company did not publish a call transcript in the period reviewed [List: earnings-call-transcript: none].

TopicPrevious Mentions (Q2 2025)Current Period (Q3 2025)Trend
R&D execution (GTB-3650)Cohorts 1–2 completed; Cohort 3 initiated; early immune activation signals Cohort 3 safety review completed; advancement to Cohort 4 (10 µg/kg/day) with no safety/tolerability issues Positive progression
Clinical data timing“More detailed results later in 2025” “Next update anticipated in Q1 2026” Timing pushed
GTB-5550 INDTarget Q4 2025 Late Dec 2025/Jan 2026 Slight push
Financing/dilution mechanicsSeries L preferred financing and warrants (May) Greenshoe exercises reduced conversion price (to $0.6421 in Q3; to $0.5319 in Oct) and increased warrants via full-ratchet protections Dilution risk rising
Legal/regulatoryActive litigation matters disclosed (notes) Matters continue; next hearing dates and motions updated Ongoing

Management Commentary

  • “We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day… we are now approaching the efficacy range predicted by preclinical in vivo leukemia models” — Michael Breen, Executive Chairman & CEO .
  • “The excellent safety profile observed with GTB-3650 and the immune activation potential of bringing IL-15 to the immune synapse suggests a potential competitive advantage for GTB-5550 compared to other modalities like bispecific antibodies, cell therapies, and antibody drug conjugates also targeting solid tumors expressing B7H3” — Michael Breen .

Q&A Highlights

No Q3 2025 earnings call transcript was found; Q&A is unavailable for this period [List: earnings-call-transcript: none].

Estimates Context

MetricQ1 2025 ConsensusQ2 2025 ConsensusQ3 2025 Consensus
Primary EPS Consensus Mean ($)−0.64*−0.68*−0.38*
Revenue Consensus Mean ($USD Millions)0.00*0.00*0.00*
Primary EPS – # of Estimates1*1*1*
Revenue – # of Estimates1*1*1*

Comparison vs actual (Q3 2025):

  • EPS: actual −$0.83 vs −$0.38* consensus → bold miss.
  • Revenue: actual $0.00 vs $0.00* consensus → in line .

Values retrieved from S&P Global*.

Key Takeaways for Investors

  • Clinical momentum remains intact: GTB-3650 progressed to Cohort 4 with clean safety to date; protocol enables escalation to 25/50/100 µg/kg/day as needed, with next update guided for Q1 2026 .
  • Cash runway into Q1 2026 was reaffirmed; quarter-end cash of $2.53M underscores the importance of continued access to capital given ongoing R&D burn .
  • Dilution overhang has increased: Greenshoe exercises lowered conversion price and expanded warrant counts via full-ratchet protections (exercise price reduced to $0.6421, then $0.5319 post-quarter), raising future supply risk .
  • Q3 2025 EPS missed consensus, while revenue matched expectations; rising SG&A (including stock comp) offset reduced R&D versus prior year .
  • Near-term catalysts: GTB-5550 IND submission targeted for late Dec 2025/Jan 2026; GTB-3650 data update in Q1 2026; cohort progression and any efficacy signals could be stock-moving events .
  • Legal matters remain ongoing but non-core; monitor potential costs or distractions ahead of clinical readouts .
  • Risk framing: going concern language persists; operational execution and financing terms warrant close monitoring through IND and dose-escalation milestones .