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Apogee Therapeutics, Inc. (APGE)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 was execution-heavy: APGE advanced APG777 into Phase 2 (first patient dosed), added APG333 (anti‑TSLP) to the portfolio, and accelerated APG990 (OX40L) Phase 1 start to Q3 2024, while reaffirming a long runway into 2028 .
  • Operating expenses rose as programs moved into/through clinical stages: R&D $33.2M (+139% YoY), G&A $10.9M (+123% YoY); net loss widened to $33.8M (vs. $18.9M YoY), partially offset by higher interest income ($10.3M) .
  • Cash, cash equivalents and marketable securities were $789.6M as of June 30, 2024; management reiterated runway into Q1 2028, supported by the March equity raise and cash positioning .
  • Wall Street consensus (S&P Global) revenue/EPS estimates for Q2 2024 were unavailable in this session; APGE did not report product revenue and did not disclose EPS in the press release. The stock’s near-term narrative hinges on upcoming clinical catalysts (APG808 interim Phase 1 in Q4 2024; APG990 Phase 1 start in Q3 2024; APG777 Phase 2 PoC in 2H 2025) .

What Went Well and What Went Wrong

What Went Well

  • Pipeline breadth and combo optionality expanded: APG333 (anti‑TSLP) added to enable IL‑13+TSLP and IL‑13+OX40L combinations for potentially deeper responses across I&I, with initial APG333 clinical entry targeted for 2025 .
  • Execution milestones on-track/accelerated: First patient dosed in APG777 Phase 2 (AD); APG808 Phase 1 HV interim data expected Q4 2024; APG990 Phase 1 HV pulled forward to Q3 2024 .
  • Management tone confident on strategy and cash runway: “We have a strong cash position taking us into 2028” and a portfolio aiming for “best‑in‑class monotherapy and combination efficacy and improved dosing schedules” (CEO Michael Henderson, M.D.) .

What Went Wrong

  • OpEx escalation with clinical advancement: R&D +$19.3M YoY and G&A +$6.0M YoY led to net loss $33.8M (vs. $18.9M in Q2 2023), despite higher interest income; investors will monitor burn trajectory vs. milestones .
  • No reported product revenue; margin/EPS analytics not meaningful at this stage and EPS was not disclosed in the Q2 release .
  • Limited disclosure cadence (no earnings call transcript located for Q2): reduces qualitative visibility into management Q&A on trial design, timelines, and competitive positioning this quarter [ListDocuments: earnings-call-transcript none for 2024-07-01 to 2024-09-30].

Financial Results

MetricQ4 2023Q1 2024Q2 2024
R&D Expenses ($USD Millions)$29.0 $28.7 $33.2
G&A Expenses ($USD Millions)$8.2 $9.5 $10.9
Net Loss ($USD Millions)$31.7 $32.1 $33.8
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$395.5 $816.2 $789.6

Notes:

  • APGE did not report product revenue and did not disclose EPS in its Q2 press release; margins are not applicable for a pre‑revenue biotech .
  • S&P Global consensus revenue/EPS for Q2 2024 were not retrievable in this session due to API limits; see Estimates Context.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of Q4 2023Into 4Q 2026
Cash runwayAs of Q1 2024Into Q1 2028 Raised vs. FY23
Cash runwayAs of Q2 2024Into Q1 2028 Into Q1 2028 Maintained

Additional qualitative guidance/catalysts:

  • APG808 interim Phase 1 HV data in Q4 2024; APG990 Phase 1 HV start in Q3 2024; APG333 Phase 1 HV anticipated in 2025; APG777 Phase 2 Part A 16‑week PoC data expected 2H 2025 .

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was found. Narrative below leverages press releases and corporate materials across quarters.

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
Dosing differentiation via extended half‑lifeAPG777 Phase 1 interim data showed ~75‑day half‑life enabling potential Q3M/Q6M maintenance; plan to exceed lebrikizumab exposures in induction Reiterated extended half‑life strategy and induction/maintenance exposure design; APG808 and APG990 also engineered for less frequent dosing Consistent, expanding across portfolio
Combination strategy (orthogonal mechanisms)Early articulation of IL‑13 + OX40L and IL‑13 + TSLP hypotheses; APG990 nomination; APG777 asthma Phase 2 in 2025 contemplated APG333 added; first APG777+APG990 trial planned for 2025; potential APG777+APG333 in respiratory indications pending APG333 data Strengthening, concrete timelines
Cash runway and capital planningYear‑end 2023 cash $395.5M; runway into 4Q 2026; March 2024 upsized offering ($483M) extended runway Cash $789.6M; runway into Q1 2028 Improved and maintained
R&D execution cadenceInitiated APG808 Phase 1 HV; APG777 Phase 2 initiation on track; APG990 Phase 1 expected in 2H 2024 APG777 Phase 2 first patient dosed; APG808 interim HV data Q4 2024; APG990 Phase 1 HV accelerated to Q3 2024 On schedule/accelerated
Regulatory and governanceRegulatory clearances for APG990 (Australia); material governance updates in 1H 2024 Board expansion with Lisa Bollinger, M.D., adding deep FDA/regulatory experience Enhanced regulatory bench

Management Commentary

  • “A key component of [our] strategy is combining several of our pipeline programs… We have strategically built a unique portfolio of IL‑13, IL‑4Rα, OX40L and TLSP inhibitors that enable multiple combinations… and we have a strong cash position taking us into 2028.” — Michael Henderson, M.D., CEO .
  • “The first half of this year has been marked with significant pipeline progress and a focus on further defining our strategy… We look forward to discussing our programs and additional plans for combination approaches in further detail at our R&D Day in December this year.” — Michael Henderson, M.D., CEO .
  • In Q1: “We raised $483 million in an upsized public offering providing capital into 2028.” — Michael Henderson, M.D., CEO .

Q&A Highlights

  • No Q2 2024 earnings call transcript was found; no Q&A highlights available for this quarter [ListDocuments: earnings-call-transcript none for 2024-07-01 to 2024-09-30].

Estimates Context

  • S&P Global consensus estimates for Q2 2024 revenue and EPS were unavailable in this session due to SPGI daily request limits; as a result, we cannot quantify beats/misses versus Wall Street estimates. APGE did not disclose EPS in its Q2 press release and remains pre‑revenue, making margin and revenue comparisons not applicable this quarter .
  • Attempted retrieval failed: “Daily Request Limit of 250000 Exceeded” for both financials and estimates tools in this session (SPGI). If required, we can re‑run once limits reset to populate the estimates table and compare actuals to consensus.

Key Takeaways for Investors

  • Cash runway into Q1 2028 provides durable funding for multiple clinical readouts across APG777 (AD), APG808 (respiratory), APG990 (AD), and APG333 (respiratory), reducing financing overhang in the near/medium term .
  • Operating expense growth reflects program advancement; monitor burn discipline relative to forthcoming catalysts (APG808 HV interim Q4 2024; APG990 Phase 1 start Q3 2024; APG777 PoC 2H 2025) as the narrative will pivot to data quality and timing .
  • The combination strategy (IL‑13 + OX40L; IL‑13 + TSLP) is a central differentiation lever; first APG777+APG990 trial planned for 2025 is a potential upside catalyst if safety/PK and efficacy signals align with mechanistic rationale .
  • Dosing differentiation (Q3M/Q6M maintenance) remains a key commercial thesis in AD and potentially in respiratory indications; execution on PK/PD durability in human trials will be critical .
  • Absence of a Q2 call reduces real‑time color; watch for the December R&D Day for detailed updates on combination regimens and respiratory development path (including APG333) .
  • Short‑term trading: stock likely sensitive to APG808 interim Phase 1 HV data in Q4 2024 and APG990 Phase 1 initiation headlines; medium‑term thesis centers on APG777 Phase 2 Part A PoC in 2H 2025 and combo validation .

Appendix: Prior Two Quarters’ Earnings (for trend reference)

  • Q1 2024: Cash $816.2M; R&D $28.7M; G&A $9.5M; Net loss $32.1M; runway into Q1 2028 .
  • Q4/FY 2023: Cash $395.5M at year‑end; quarterly R&D $29.0M; quarterly G&A $8.2M; quarterly net loss $31.7M; runway into 4Q 2026 (pre‑offering) .

Additional Notes

  • Other Q2-period press releases: none found beyond the 8‑K furnished press release for Q2 results [ListDocuments: 8-K press release 2024-08-12; press-release none for 2024-07-01 to 2024-09-30].
  • Corporate presentation (Exhibit 99.2) reiterated strategy, timelines, and market context for AD/asthma/COPD and combinations .