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Septerna, Inc. (SEPN)·Q3 2024 Earnings Summary

Executive Summary

  • Septerna delivered a clinical- and financing-driven quarter: Phase 1 for SEP-786 began in September with data expected mid-2025, and the company closed an upsized IPO in October, adding ~$302.6M net proceeds; cash and marketable securities were $137.5M at quarter-end, supporting runway into 2H 2027 .
  • Operating loss widened year over year on higher R&D and G&A, with minimal revenue; Q3 revenue was $0.18M, net loss was $20.5M, and diluted EPS was -$8.40 .
  • Management emphasized a “deep pipeline” across endocrinology, immunology/inflammation, and metabolic diseases, led by SEP-786 (PTH1R agonist) and SEP-631 (MRGPRX2 NAM), and advanced TSHR and incretin programs .
  • No earnings call transcript was available for Q3 2024; consensus EPS/revenue estimates from S&P Global were unavailable at time of analysis, limiting beat/miss assessment .

What Went Well and What Went Wrong

What Went Well

  • Initiated Phase 1 trial for SEP-786 with SAD/MAD design; data expected mid-2025, advancing the lead endocrine program. CEO: “we recently celebrated two major milestones: our transition to a clinical-stage company… and our debut as a public company” .
  • Strengthened balance sheet and extended runway: Q3 cash/marketable securities $137.5M; IPO net proceeds ~$302.6M; runway into 2H 2027 .
  • Pipeline breadth and progress: SEP-631 in IND-enabling; TSHR NAMs reversing hyperthyroidism in models; advancing next‑gen oral incretin receptor program candidates .

What Went Wrong

  • Operating expenses ramped meaningfully: R&D $17.8M (+92% YoY); G&A $4.9M (+76% YoY); total OpEx $22.7M (+88% YoY), driving operating loss to -$22.6M (vs -$12.0M YoY) .
  • Net loss widened to $20.5M (vs $10.9M YoY) with diluted EPS -$8.40 (vs -$5.45), reflecting higher spend pre- and post-IPO and limited revenue generation .
  • Revenue remained de minimis ($0.18M), underscoring early-stage status and dependence on financing and partnership inflows rather than product revenues .

Financial Results

MetricQ3 2023Q3 2024
Revenue ($USD Millions)$0.03 $0.18
Net Loss ($USD Millions)$10.9 $20.5
Diluted EPS ($USD)-$5.45 -$8.40
Operating Expenses ($USD Millions)Q2 2024Q3 2024
R&D$15.0 $17.8
G&A$3.4 $4.9
Total Operating Expenses$18.4 $22.7

Note: Prior-quarter (Q2 2024) revenue and EPS were not furnished in an 8-K 2.02; select OpEx metrics sourced from later IR materials. No Q1 2024 earnings materials were found in company filings/IR.

Segment breakdown: Not applicable; the company does not report revenue segments at this stage .

KPIs

KPI12/31/20239/30/2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$88.5 $137.5
Working Capital ($USD Millions)$105.8 $120.2
Total Assets ($USD Millions)$130.9 $174.3
Total Liabilities ($USD Millions)$20.0 $37.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateN/AOperating runway into 2H 2027 Maintained/affirmed for first disclosure
SEP-786 Phase 1 ReadoutProgram TimingN/ASAD/MAD data expected mid-2025 New disclosure (timing specified)
SEP-631 Next StepProgram TimingIND-enabling ongoingAnticipated Phase 1 initiation (timing not specified in Q3 PR) Maintained trajectory

No revenue/earnings/OpEx quantitative guidance ranges were issued in Q3 materials .

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was found; themes below reflect press releases and filings.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
R&D execution (SEP-786)N/A earnings materials; Phase 1 initiation disclosed late Q3 Phase 1 SAD/MAD initiated; mid-2025 data timing Advancing to first-in-human
Financing runway/IPON/A earnings materialsIPO closed; ~$302.6M net proceeds; runway into 2H 2027 Strengthened liquidity
Immunology (SEP-631)IND-enabling; staffing adds (CMO appointment) IND-enabling continues; Phase 1 anticipated Progressing toward clinic
Endocrinology (TSHR NAMs)Preclinical advances (ASBMR data, late Sep) Reversals of hyperthyroidism/proptosis in models; development candidate selection work ongoing Continued preclinical validation
Metabolic (incretin program)Discovery-stage profiling disclosedProgressing lead compounds toward candidate selection Building optionality

Management Commentary

  • “Our Native Complex Platform has yielded a deep pipeline of oral small molecule programs… Leading our pipeline is SEP-786, which we believe could transform hypoparathyroidism treatment by providing full-day calcium control with a convenient, disease-modifying oral therapy.” — Jeffrey Finer, CEO .
  • “Well-capitalized… following a successful IPO… we believe we are well positioned to deliver multiple novel GPCR medicines.” — Jeffrey Finer, CEO .

Q&A Highlights

  • No earnings call transcript or Q&A materials for Q3 2024 were found across SEC filings and IR sources .

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q3 2024 were unavailable at time of analysis due to data access limits; as a result, beat/miss vs Wall Street could not be assessed .
  • Given the limited revenue and rising OpEx profile, near-term estimate adjustments (when available) will likely center on R&D/G&A trajectories and clinical milestone timing rather than top-line variability .

Key Takeaways for Investors

  • Liquidity and runway validated: quarter-end cash of $137.5M plus ~$302.6M IPO proceeds extend the runway into 2H 2027, lowering near-term financing risk and supporting multiple programs through key readouts .
  • Clinical catalyst set: SEP-786 Phase 1 SAD/MAD data targeted for mid-2025; sustained execution in 2025 could shift investor focus toward biomarker evidence of calcium control and dose/titration strategies ahead of patient studies .
  • Expense trajectory rising: Q3 OpEx increased sharply YoY; watch cost discipline and allocation across SEP-786, SEP-631, and TSHR/incretin programs as management balances breadth with clinical depth .
  • Early-stage revenue: Q3 revenue was $0.18M; the investment case pivots on de-risking milestones and partnership economics rather than product sales in the near term .
  • Pipeline breadth is strategic: Multiple GPCR targets across endocrine, immunology/inflammation, and metabolic diseases provide optionality and potential for external collaborations to offset burn .
  • Near-term trading implication: Newsflow (trial progress, INDs, IPO momentum) likely drives stock moves absent financial beats; align positions with clinical readout timelines and any incremental IR updates .
  • Medium-term thesis: If Phase 1 data demonstrate targeted PK/PD and favorable safety for SEP-786, the path to patient studies and potential pivotal design clarity could re-rate execution risk and support valuation resilience .

Additional Q3 2024 References (Press Releases)

  • Septerna Reports Third Quarter 2024 Financial Results and Recent Business Highlights (IR site) .
  • Septerna Announces Initiation of Phase 1 Clinical Trial with SEP-786 (Sep 27, 2024) .
  • ASBMR 2024 Preclinical Data (Sep 30, 2024) .

Notes:

  • Primary source Q3 2024 press release was furnished as Exhibit 99.1 to Form 8-K with embedded financial statements .
  • No Q3 2024 earnings call transcript was listed or retrievable via filings/IR during the period reviewed .