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Protara Therapeutics, Inc. (TARA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was an operationally constructive quarter highlighted by positive interim data for TARA-002 in NMIBC showing 100% CR at any time (5/5) and 67% 12‑month CR (2/3) in the BCG‑Unresponsive cohort; BCG‑Naïve cohort showed 76% CR at any time (16/21) and 43% 12‑month CR (3/7) .
  • Cash, cash equivalents, and marketable securities were $157.5M, with runway guided into 2027; R&D rose on clinical activity, and net loss was $11.9M ($0.29 per share) .
  • Guidance shifts: THRIVE‑3 registrational trial start moved to Q3 2025 (from prior 1H 2025); BCG‑Naïve registrational design update moved to 2H 2025 (from prior by end of 1H 2025); STARBORN‑1 interim update moved to 2H 2025 (from prior by end of 1H 2025) .
  • Near‑term catalysts: continued ADVANCED‑2 updates (including ~25 six‑month evaluable BCG‑Unresponsive patients by year‑end 2025) and initiation of THRIVE‑3 in Q3 2025 .

What Went Well and What Went Wrong

What Went Well

  • Positive ADVANCED‑2 interim efficacy and durability in NMIBC: BCG‑Unresponsive CR 100% at any time and 67% at 12 months; BCG‑Naïve CR 76% at any time and 43% at 12 months; favorable safety with no Grade ≥3 TRAEs .
    “We believe TARA‑002 is well positioned to make a meaningful difference in the lives of patients with non‑muscle invasive bladder cancer” — CEO Jesse Shefferman .
  • Clear path to registrational efforts: BCG‑Unresponsive cohort designed to be registrational per 2024 FDA draft guidance; interim results for ~25 six‑month evaluable BCG‑Unresponsive patients targeted by end‑2025 .
  • Strong liquidity and runway: $157.5M cash/securities at 3/31/25, runway guided into 2027; supports execution across NMIBC, LMs, and IV Choline programs .

What Went Wrong

  • Timeline slippage: THRIVE‑3 registrational start moved from 1H 2025 (prior) to Q3 2025 (current); BCG‑Naïve registrational design update pushed from end‑1H 2025 (prior) to 2H 2025; STARBORN‑1 interim update shifted to 2H 2025 from end‑1H 2025 .
  • Operating expense growth: R&D increased to $9.1M (+$1.4M YoY), driven by +$2.6M clinical trial activity for TARA‑002 and IV Choline; G&A up to $5.0M on personnel and professional fees .
  • Continued losses: Net loss of $11.9M and diluted EPS of $(0.29) (vs $(11.1)M and $(0.97) in Q1 2024), reflecting clinical‑stage profile and higher OpEx .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Research & Development ($USD Millions)$8.07 $9.50 $9.15
General & Administrative ($USD Millions)$4.26 $4.81 $4.98
Total Operating Expenses ($USD Millions)$12.33 $14.31 $14.12
Net Loss ($USD Millions)$(11.22) $(12.77) $(11.91)
Diluted EPS ($USD)$(0.50) $(0.48) $(0.29)
Weighted Avg Shares (Basic & Diluted)22,329,772 26,432,563 40,707,937
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$81.5 $170.3 $157.5

Notes:

  • Company did not disclose revenue; statements present operating expenses and net loss only (consistent with clinical‑stage status) .

Clinical KPIs (ADVANCED‑2 Interim Data)

KPIQ3 2024Q4 2024Q1 2025
CR at any time (BCG‑Unresponsive)N/APart of overall CR at any time 70% (14/20) across exposures 100% (5/5)
CR at 12 months (BCG‑Unresponsive)N/AN/A67% (2/3)
CR at any time (BCG‑Naïve)N/APart of overall CR at any time 70% (14/20) across exposures 76% (16/21)
CR at 12 months (BCG‑Naïve)N/AN/A43% (3/7)
Safety (TRAEs Grade ≥3)N/ANo Grade ≥2 TRAEs reported in interim data No Grade ≥3 TRAEs; majority Grade 1/transient

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
THRIVE‑3 (IV Choline) registrational start2025 start1H 2025 Q3 2025 Lowered (delayed)
BCG‑Naïve registrational trial design update2025By end of 1H 2025 2H 2025 Lowered (delayed)
STARBORN‑1 interim update (LMs)2025By end of 1H 2025 2H 2025 Lowered (delayed)
ADVANCED‑2 interim (≈25 six‑month evaluable BCG‑Unresponsive)2025By end of 2025 By end of 2025 Maintained
Cash runwayMulti‑yearInto 2027 Into 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
NMIBC efficacy/durabilityOn track for interim six‑month analysis 4Q24; planning 12‑month mid‑2025 Positive updated interim data with 12‑month CRs; continued registrational alignment Improving efficacy narrative; durability reinforced
Regulatory alignment (registrational strategy)BCG‑Unresponsive cohort designed per 2024 FDA guidance Continues; planning additional BCG‑Naïve registrational design Stable; expanding
IV Choline programFast Track; THRIVE‑3 start targeted 1Q/1H 2025 THRIVE‑3 planned Q3 2025 Timing delayed
LMs program (STARBORN‑1)First cohort encouraging; interim update 1H 2025 Interim update now 2H 2025 Timing delayed
Corporate/leadershipN/ANew CMO and Chief People Officer appointed Strengthened leadership bench

Management Commentary

  • “We have made significant progress thus far in 2025… positive interim results from our ADVANCED‑2 trial… demonstrated durable 12‑month landmark responses. We believe TARA‑002 is well positioned to make a meaningful difference in the lives of patients with NMIBC.” — CEO Jesse Shefferman .
  • “The durable results shared today continue to support our conviction that TARA‑002 has the potential to make a meaningful difference in the lives of patients with NMIBC.” — CEO Jesse Shefferman (AUA interim data) .
  • R&D drivers: “Increase was primarily due to a $2.6 million increase in clinical trial activities for TARA‑002 and IV Choline” .
  • Liquidity: “Unrestricted cash and cash equivalents and investments… totaled $157.5 million… sufficient to fund operations into 2027” .

Q&A Highlights

  • The May 8 press release did not reference an earnings call; no Q1 2025 earnings call transcript was located in our document set. Company did host an AUA data call/webcast on April 28 to discuss ADVANCED‑2 updates (12‑month evaluation) .

Estimates Context

MetricQ1 2025 ConsensusActualSurprise
EPS ($)Unavailable*$(0.29) N/A*
Revenue ($USD)Unavailable*Not disclosed N/A*

*Values retrieved from S&P Global.

Note: Consensus estimates via S&P Global were unavailable for Q1 2025 (common for micro‑cap, clinical‑stage biotechs); therefore no beat/miss determination could be made.

Key Takeaways for Investors

  • Clinical momentum in NMIBC: BCG‑Unresponsive efficacy and durability data remain competitive, with 12‑month CR at 67%; safety profile favorable with no Grade ≥3 TRAEs — supports registrational intent and potential value inflection with additional interim readouts in 2025 .
  • Milestone visibility: Expect interim results (~25 six‑month evaluable BCG‑Unresponsive) by end‑2025 and THRIVE‑3 initiation in Q3 2025 — clear catalyst path into 2H 2025 and early 2026 .
  • Execution capacity: $157.5M liquidity and runway guided into 2027 provide funding to reach multiple clinical milestones without near‑term financing overhang .
  • Watch timelines: Several guidance items slipped (THRIVE‑3, BCG‑Naïve design, STARBORN‑1 interim) — monitor adherence to updated schedules to sustain investor confidence .
  • P&L dynamics: OpEx growth driven by clinical activity is expected at this stage; net losses should be assessed against milestone cadence rather than near‑term profitability .
  • Stock‑moving narrative: Further durability data (especially 12‑month outcomes) and clarity on registrational designs (BCG‑Naïve) can reset probability of success assumptions and influence sentiment; THRIVE‑3 initiation is a second pillar for non‑oncology optionality .
  • Coverage gap: Lack of consensus estimates reduces headline beat/miss catalysts; trading may be more event‑driven around clinical updates and regulatory interactions rather than quarterly prints .