Neumora Therapeutics, Inc. (NMRA)·Q3 2024 Earnings Summary

Executive Summary

• Neumora delivered a pipeline‑driven quarter with operating expenses rising as KOASTAL Phase 3 execution accelerated; cash, cash equivalents and marketable securities were $341.3M, with runway now “into mid‑2026,” slightly tightening guidance language relative to earlier “into 2026” phrasing .
• No revenue was reported; GAAP net loss widened sequentially to $(72.5)M and $(0.45) per share on higher R&D tied to Phase 3 navacaprant, consistent with company commentary .
• Management reiterated timing: KOASTAL‑1 topline readout “around the end of 2024”; KOASTAL‑2/‑3 topline in 1H25; navacaprant bipolar depression Phase 2 and NMRA‑511 AD agitation Phase 1b data in 2H25; an additional M4 PAM IND expected 1H25 .
• Near‑term stock catalyst is the KOASTAL‑1 Phase 3 MDD readout; Q&A emphasized multiple placebo‑mitigation design/execution measures and optional sample‑size flexibility to support probability of success .

What Went Well and What Went Wrong

• What Went Well

  • Advanced KOASTAL Phase 3 program with detailed design/execution enhancements (MADRS primary endpoint, central raters, placebo‑expectation scripting, video‑verified dosing), aimed at reducing placebo effects and improving data quality: “state‑of‑the‑art” measures to increase probability of success .
  • Balance sheet and runway: $341.3M in cash, equivalents and marketable securities; runway now expected into mid‑2026, positioning company through multiple readouts .
  • Pipeline breadth maintained: KOASTAL‑1 readout around year‑end; KOASTAL‑2/‑3 in 1H25; navacaprant bipolar depression Phase 2 and NMRA‑511 AD agitation Phase 1b data in 2H25; additional M4 PAM IND 1H25 .
  • Quote: “We look forward to announcing topline data from KOASTAL‑1… around the end of the year… [navacaprant] has the potential to reshape the treatment of MDD” — CEO Henry Gosebruch .

• What Went Wrong

  • Operating expenses rose materially YoY and sequentially as Phase 3 progressed; R&D up to $60.6M (vs $48.6M in Q2 and $41.6M YoY), driving wider net loss $(72.5)M .
  • Interest income trended lower sequentially ($6.37M → $5.27M → $4.21M Q1→Q3), reducing a natural offset to OpEx .
  • M4 franchise execution required pivot: prior disclosures highlighted a clinical hold on NMRA‑266; strategy now emphasizes advancing an additional M4 PAM with an IND targeted for 1H25 (maintained in Q3) .

Financial Results

Notes:

• No revenue was reported; the company’s GAAP statement of operations presents operating expenses and net loss without a revenue line item .
• Drivers: R&D increase “primarily due to advancement of clinical and preclinical programs and related activities for Phase 3 clinical trials evaluating navacaprant as a monotherapy treatment for MDD” .

Segment breakdown: Not applicable; no product revenues disclosed .

KPIs (Operating/Balance Sheet)

• Cash runway guidance: “into mid‑2026” as of 9/30/24 .
• Weighted‑average diluted shares: 159.576M in Q3 2024 vs 158.984M in Q2 2024 and 157.943M in Q1 2024 .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategy and vision: “We look forward to announcing topline data from KOASTAL‑1… around the end of the year… [navacaprant] has the potential to reshape the treatment of MDD by meeting outstanding unmet needs that current therapies do not adequately address.” — Henry Gosebruch, CEO .
• Pipeline breadth: “We… expanded navacaprant’s potential with a Phase 2 study in bipolar depression and are advancing a Phase 1b study of NMRA‑511… data expected in the second half of 2025… plan to submit an IND [for an M4 PAM] in the first half of 2025.” — CEO .
• Financial posture: “We ended the third quarter with $341.3 million… which we expect to support operations into mid‑2026.” — CFO Josh Pinto (also in press release ).
• Phase 3 design/execution: “We implemented… measures [design and oversight] to increase the probability of success… MADRS primary endpoint… central raters… video apps for dosing compliance… placebo script…” — Head of R&D Rob Lenz .
• Dose rationale: “80 mg achieves ~90% [KOR] receptor occupancy throughout the dosing period… ~300‑fold selectivity for kappa over mu.” — Rob Lenz .

Q&A Highlights

• Placebo and execution quality: Management detailed multiple measures (central raters, expectation‑bias scripts, video‑verified dosing, site/rater QC) designed to mitigate placebo response and improve data integrity .
• Sample size flexibility: KOASTAL studies powered ~90% targeting ~332 patients each; design permitted seamless enrollment increase up to 25% without protocol amendment; more detail to come at topline .
• Safety/dose selection: Human PET demonstrated ~90% KOR occupancy at 80 mg; favorable tolerability vs SOC side effects (e.g., weight gain/sexual dysfunction not observed in Phase 2) .
• Commercialization intent: If successful, company is positioned to commercialize navacaprant on its own in the U.S. .
• M4 franchise context: Team reiterated confidence in M4 despite competitor readouts; multiple differentiated M4 PAMs, IND for additional program targeted 1H25 .

Estimates Context

• Wall Street consensus estimates (S&P Global) for Q3 2024 EPS and revenue were not retrievable at the time of query due to SPGI rate limits; the company reported no revenue and provided only GAAP results (no non‑GAAP) in its materials . Consensus comparisons are therefore unavailable at this time (Values would be retrieved from S&P Global when accessible).

Key Takeaways for Investors

• The KOASTAL‑1 Phase 3 MDD topline “around the end of 2024” is the decisive near‑term catalyst; multiple execution safeguards aim to reduce placebo risk and support readout quality .
• Operating spend ramp (R&D +24.7% QoQ; +45.8% YoY) reflects Phase 3 intensity; expect continued investment through Phase 3 readouts, with sequential net loss widening in Q3 .
• Cash runway into mid‑2026 reduces near‑term financing overhang and covers KOASTAL‑2/‑3, bipolar depression Phase 2, and NMRA‑511 Phase 1b data, plus M4 IND in 1H25 .
• Broader optionality: Positive KOASTAL data could enable a broad MDD monotherapy label (MADRS primary) and reinforce expansion into bipolar depression where anhedonia remains poorly addressed .
• Commercial path: Company indicates readiness to self‑commercialize in the U.S. contingent on success—an important consideration for valuation and partner optionality .
• M4 franchise remains a 2025+ call option with an additional IND planned for 1H25, shifting focus beyond the NMRA‑266 hold .
• Trading setup: Binary KOASTAL‑1 readout timing into year‑end should drive elevated event risk and positioning; subsequent KOASTAL‑2/‑3 readouts in 1H25 create a catalyst cadence .