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Protara Therapeutics, Inc. (TARA)·Q4 2024 Earnings Summary
Executive Summary
- Protara reported Q4 2024 net loss of $12.8M and diluted EPS of $(0.48); R&D rose to $9.5M and G&A to $4.8M, reflecting advancing clinical programs .
- Positive six‑month ADVANCED‑2 data in NMIBC: 72% six‑month CR across BCG exposures, 100% six‑month CR in BCG‑Unresponsive; favorable safety with no Grade ≥2 TRAEs—key catalyst ahead of 12‑month data mid‑2025 .
- Cash, cash equivalents and marketable debt securities were $170.3M at 12/31/24; cash runway extended into 2027, bolstered by $100M equity offering in December 2024 (13.69M shares + 2.33M pre‑funded warrants at $6.25) .
- THRIVE‑3 registrational trial (IV Choline Chloride) now guided to initiate in 1H 2025 vs prior Q1 2025, with Fast Track designation secured; STARBORN‑1 (LMs) interim update expected by end of 1H 2025 .
What Went Well and What Went Wrong
What Went Well
- Strong clinical signal: ADVANCED‑2 achieved 72% six‑month CR across BCG exposures and 100% six‑month CR in BCG‑Unresponsive, with durable responses and no Grade ≥2 TRAEs; “We are thrilled with these positive six‑month data…” (CEO) .
- Strengthened balance sheet and runway: Year‑end cash, equivalents, and marketable securities at $170.3M; management expects funding into 2027 .
- Regulatory momentum: FDA Fast Track for IV Choline Chloride; alignment on registrational THRIVE‑3 design .
What Went Wrong
- Loss widened YoY in Q4: Net loss $(12.8)M vs $(10.2)M prior year; operating expenses increased to $14.3M (R&D $9.5M, G&A $4.8M) as programs advanced .
- THRIVE‑3 timetable modestly slipped to 1H 2025 from prior Q1 2025 expectations .
- Dilution from capital raise: Common shares outstanding rose to 35.0M at 12/31/24 following the $100M offering .
Financial Results
Income Statement and EPS
Notes: Company reported no product revenue; statements present operating expenses and net results without revenue lines .
Balance Sheet and Liquidity
KPIs (Clinical and Operational)
Guidance Changes
Earnings Call Themes & Trends
Note: No Q4 earnings call transcript was found; themes reflect management disclosures across quarterly releases.
Management Commentary
- “Supported by positive six‑month data from our Phase 2 ADVANCED‑2 trial in non‑muscle invasive bladder cancer (NMIBC), we continue to believe TARA‑002 could represent a differentiated, meaningful addition to the treatment paradigm…” — CEO Jesse Shefferman .
- “We remain on track to commence our pivotal THRIVE‑3 trial of intravenous (IV) Choline Chloride in the first half of the year.” — CEO Jesse Shefferman .
- “With our cash runway extending into 2027, we look forward to achieving many critical milestones across all of our development programs…” — CEO Jesse Shefferman .
- “These impressive TARA‑002 results demonstrate meaningful activity in a difficult to treat patient population.” — Study investigator Brian Mazzarella, MD .
Q&A Highlights
- No Q4 earnings call transcript was available; the Dec 5 data release included a webcast for clinical results, but no transcript was found in the document set .
Estimates Context
- Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable in this session; SPGI returned request‑limit errors, so comparison versus consensus could not be completed at this time. As a pre‑revenue biotech, reported results comprised operating expenses and net loss rather than revenue/EPS versus sell‑side expectations .
Key Takeaways for Investors
- Clinical traction is the main driver: strong ADVANCED‑2 six‑month CR rates and clean safety profile set up 12‑month mid‑2025 readouts as a major catalyst .
- Balance sheet de‑risked: $170.3M cash and marketable securities and runway into 2027 following $100M raise; supports execution through key milestones .
- Near‑term events: THRIVE‑3 initiation in 1H 2025 (IV Choline Chloride, Fast Track) and STARBORN‑1 interim update by end of 1H 2025 broaden the catalyst calendar .
- Operating spend rising with pipeline progression; Q4 OpEx and net loss increased YoY as trials scale—watch OpEx discipline versus clinical timelines .
- Modest timing adjustment on THRIVE‑3 (Q1 → 1H 2025) should be monitored; any further delay could shift the medium‑term thesis on IV Choline .
- Dilution from the equity offering increased shares outstanding; focus shifts to value creation via data and regulatory milestones to offset dilution .
- Absent revenue, stock reaction will hinge on clinical/regulatory newsflow; maintaining momentum and clarity on registrational paths is critical to sustaining investor confidence .