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Terns Pharmaceuticals, Inc. (TERN)·Q1 2025 Earnings Summary
Executive Summary
- In-line quarter operationally with a modest EPS beat: Q1 2025 GAAP EPS of $(0.26) versus S&P Global consensus of $(0.27); no product revenue reported as the company remains clinical-stage . EPS consensus and revenue consensus from S&P Global shown with asterisks below.*
- Key pipeline execution maintained: completed TERN-701 Phase 1 dose escalation and initiated dose expansion in April; FALCON Phase 2 (TERN-601, oral GLP‑1 RA) enrolling well; both programs guide to 4Q25 data readouts (6‑month MMR for 701; 12‑week weight loss for 601) .
- Cash of $334.3M at 3/31/25 supports runway “into 2028,” unchanged from prior guidance, providing funding through near-term catalysts .
- Potential stock catalysts near-term: clarity on 701 dose‑expansion enrollment cadence and any interim updates; medium-term: two 4Q25 data readouts that could re-rate the pipeline depending on efficacy/tolerability and approvable endpoints (6‑month MMR) .
What Went Well and What Went Wrong
What Went Well
- Executed quickly on 701: “Dose escalation…completed in less than a year” and dose expansion initiated in April with 320 mg and 500 mg QD cohorts; target is to assess 6‑month MMR in 4Q25, the regulatory endpoint for 2L+ CML .
- Strong early profile for 701: no dose‑limiting toxicities through 500 mg, linear PK with QD dosing, and “compelling molecular responses” in heavily pretreated patients, supporting selection of high-end doses for expansion .
- FALCON Phase 2 enrollment “is enrolling well” with 12‑week topline weight-loss data expected in 4Q25; management continues to position 601 on oral convenience and tolerability differentiation .
What Went Wrong
- Operating loss widened modestly YoY: net loss $(23.9)M vs $(22.4)M in Q1’24, driven by higher G&A ($8.7M vs $6.9M) while R&D was roughly flat ($18.7M vs $18.6M) .
- Limited new financial levers near-term: with no product revenue, quarterly P&L remains driven by opex and interest income ($3.6M in Q1), keeping EPS tied to spending cadence until data inflections .
- No formal Q1 earnings call transcript found (typical for some small-cap biotech), limiting real-time guidance nuance; however, management discussed programs and partnering approach at a May 7 conference .
Financial Results
P&L and EPS trend (USD Millions, except per-share)
Note: Company reports no product revenue; financial statements presented begin with operating expenses (consistent with clinical-stage status) .
Cash and Balance Sheet (USD Millions)
Actual vs. S&P Global Consensus (Q1 2025)
Values with asterisks retrieved from S&P Global.
Guidance Changes
Earnings Call Themes & Trends
Note: No Q1 2025 earnings call transcript located; commentary informed by company press releases and May 7, 2025 Citizens/JMP conference transcript.
Management Commentary
- “Terns had a strong start to 2025…we have initiated enrollment in the dose expansion portion of [TERN‑701]…[and] the Phase 2 FALCON trial of TERN‑601 in obesity is enrolling well…we remain on track to deliver meaningful data from both these studies in the second half of this year” — CEO Amy Burroughs .
- “TERN‑701 showed highly encouraging safety with no dose limiting toxicities…linear pharmacokinetics with once daily dosing, and compelling molecular responses…[which] allowed us to select doses at the top end…for dose expansion.” — CMO Emil Kuriakose, MD .
- Obesity partnering rationale: registration scale ($0.5–$1.0B) and GP commercial footprint argue for pharma partnership; company open to risk‑sharing given multiple programs — CFO Andrew Gengos .
Q&A Highlights
- 701 early efficacy/safety: management reiterated a 3‑month cumulative MMR of ~50% in an early 15‑patient dataset (Oct cut) with no DLTs and absence of LFT/pancreatic enzyme elevations; 6‑month MMR readout prioritized for 4Q25 .
- 701 dose expansion: initiated; excludes certain mutations to create a more homogeneous population; doses at 320/500 mg QD; aim is increased N and longer follow‑up for 6‑mo MMR .
- 601 differentiation: focus on tolerability via PK/pharmaceutical properties; slower titration in 12‑week Phase 2 vs aggressive 28‑day Phase 1, with expectation of improved tolerability .
- Competitive landscape: views Lilly’s orforglipron as establishing the oral GLP‑1 market; Terns positions 601 for patient‑friendly titration and tolerability; sees multiple viable players .
- BD stance: obesity program intended to be partnered; continued execution across pipeline provides optionality in deal structures .
Estimates Context
- Q1 2025 GAAP EPS: $(0.26) vs consensus $(0.27); beat by $0.01. Four EPS estimates contributed to the consensus.*
- Q1 2025 Revenue: company reported no product revenue; consensus was $0.0M* on six revenue estimates.*
Values with asterisks retrieved from S&P Global.
Key Takeaways for Investors
- Pipeline execution is on track for two 4Q25 catalysts (701 6‑mo MMR and 601 12‑week weight loss), which are likely to be the primary stock drivers near-term .
- 701’s safety/PK profile (no DLTs through 500 mg, QD dosing, favorable DDI profile) and selection of higher doses for expansion support a potential best‑in‑class allosteric profile if 6‑mo MMR translates at scale .
- 601 will be judged on competitive weight loss plus tolerability/simplicity; Phase 2 design targets simple titration and patient convenience themes discussed with prescribers .
- Balance sheet provides runway into 2028, enabling data‑driven decision making without near‑term financing pressure under current plans .
- Expect partnering discussions for 601 ahead of or around 12‑week data if differentiation is confirmed; company open to risk‑sharing structures given multi‑asset pipeline .
- Near-term trading setup: limited financial surprises (no revenue model), sensitivity to any interim program updates, competitor data (oral GLP‑1 class), and conference commentary .
- Risk factors: dependence on clinical outcomes; competition in CML (asciminib) and obesity (Lilly/Novo); any tolerability/efficacy shortfall vs evolving benchmarks could pressure shares .