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Regulus Therapeutics Inc. (RGLS)·Q3 2024 Earnings Summary

Executive Summary

  • Regulus reported a larger GAAP net loss as R&D spend accelerated with RGLS8429 Phase 1b progress, ending Q3 with $87.3M in cash and runway into H1 2026 .
  • Clinical execution remained on track: cohort 4 (300 mg Q2W, open-label) of the Phase 1b MAD study completed enrollment (26 pts) in October; preliminary topline data from a substantial number of patients expected in early 2025; End‑of‑Phase 1 meeting targeted by year-end 2024 .
  • Prior cohorts continued to show dose‑responsive increases in urinary polycystins (PC1/PC2) and exploratory reductions in htTKV; 70% of 3 mg/kg patients in cohort 3 showed htTKV reductions after three months, with safety profile remaining favorable .
  • No Q3 earnings call transcript or S&P Global consensus estimates were available; therefore, no quantitative beat/miss analysis vs. Street is provided. This limits near-term trading narrative to clinical/regulatory catalysts (EoP1, cohort 4 topline) and cash runway .

What Went Well and What Went Wrong

  • What Went Well

    • Cohort 4 enrollment completed (26 patients), keeping timelines intact; topline data from a substantial number of these patients expected in early 2025, and EoP1 by year-end 2024 .
    • Cohort 3 demonstrated 70% of patients with htTKV reductions and statistically significant PC1/PC2 increases vs placebo at 3 mg/kg, reinforcing mechanistic activity and potential disease impact after short treatment duration .
    • CEO emphasized team momentum and strong position into 2025: “We are in a strong position as we move towards the end of the year and into 2025” and reiterated early‑2025 topline timing for cohort 4 .

  • What Went Wrong

    • Operating expenses continued to rise with clinical advancement: Q3 R&D of $11.3M vs. $5.5M in Q3’23 and $8.3M in Q2’24; G&A also ran higher YoY, driving wider net loss .
    • Lack of a Q3 earnings call transcript and unavailable S&P Global consensus reduces visibility into investor Q&A, Street expectations, and potential estimate revisions .
    • With no reported revenue and ongoing trials, financial performance remains driven by spend and other income; dilution already visible in rising weighted average shares from Q1 to Q3 2024 .

Financial Results

Note: Development‑stage company; no revenue line disclosed in the press releases.

Income statement (GAAP)

Metric ($USD Millions except per‑share and shares)Q3 2023Q1 2024Q2 2024Q3 2024
R&D Expense5.488 6.040 8.309 11.347
G&A Expense2.637 2.786 3.951 3.863
Total Operating Expenses8.125 8.826 12.260 15.210
Other Income, net0.301 0.357 1.225 1.148
Net Loss(7.824) (8.469) (11.036) (14.062)
Diluted EPS ($)(0.40) (0.29) (0.17) (0.21)
Weighted Avg Shares (Millions)19.629 28.747 64.465 65.471

Balance sheet and liquidity

Metric ($USD Millions)Q1 2024 (3/31)Q2 2024 (6/30)Q3 2024 (9/30)
Cash, Cash Equivalents & Short‑Term Investments107.725 95.929 87.309
Total Assets114.138 104.119 93.763
Term Loan (less issuance costs)0.540 0.000 0.000
Stockholders’ Equity107.588 98.181 86.805
Company‑stated Cash RunwayInto H1 2026 Into H1 2026 Into H1 2026

KPIs and operating highlights

KPIQ1 2024Q2 2024Q3 2024
Phase 1b MAD ProgressInitiated cohort 4; cohort 3 topline expected mid‑2024 Positive cohort 3 topline; 70% showed htTKV reductions; statistically significant PC1/PC2 increases vs placebo at 3 mg/kg Completed cohort 4 enrollment (26 pts); 300 mg Q2W; topline from substantial number of patients expected early 2025
Regulatory MilestonesPreparing for EoP1; runway strengthened by $100M private placement Plan to request EoP1 meeting in Q4 2024; potential Phase 2/3 under Accelerated Approval discussed On track for EoP1 by year‑end 2024
IP/Platform——UTSW patent & tech license for miR‑17 ADPKD IP; $62.5K upfront plus reimbursed expenses and milestones

Guidance Changes

MetricPeriodPrevious Guidance (Q2 2024)Current Guidance (Q3 2024)Change
Cash RunwayCorporateInto H1 2026 Into H1 2026 Maintained
End‑of‑Phase 1 FDA Meeting2024Request/target in Q4 2024 On track by year‑end 2024 Maintained
Cohort 4 Topline ReadoutEarly 2025Early 2025 for substantial number of subjects Early 2025 for substantial number of patients Maintained

Earnings Call Themes & Trends

Note: No Q3’24 earnings call transcript found.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
R&D Execution (RGLS8429)Q1: Initiated cohort 4; cohort 3 topline mid‑2024 . Q2: Positive cohort 3 topline (PC1/PC2, htTKV) .Completed cohort 4 enrollment; 300 mg Q2W regimen .Improving/On‑track
Regulatory PathQ2: Plan to request EoP1 in Q4 2024; discuss potential Phase 2/3 under Accelerated Approval .On track for EoP1 by year‑end 2024 .Steady progress
Capital/RunwayQ1: $100M private placement; runway into H1 2026 . Q2: Runway reaffirmed .Runway into H1 2026 reiterated .Stable
Safety ProfileQ2: Well tolerated; no safety concerns at 3 mg/kg; no adverse kidney function signals .Reinforced by mechanistic data and transition learnings vs RGLS4326 (removal of off‑target AMPAR issue) .Stable/Positive
IP Positioning—UTSW license for miR‑17 ADPKD IP; $62.5K upfront, plus milestones .Strengthening
Index/CorporateQ2: Added to Russell 3000/2000 .—One‑off completed

Management Commentary

  • “We are in a strong position as we move towards the end of the year and into 2025. We expect to share preliminary topline data from a substantial number of patients from the fourth cohort … in early 2025.” — Jay Hagan, CEO .
  • Management highlighted continued dose‑responsive mechanistic activity (PC1/PC2) and exploratory htTKV reductions in earlier cohorts, and reiterated the EoP1 timeline by year‑end 2024 .
  • The company emphasized strategic IP progress via the UTSW license to miR‑17 ADPKD patents, supporting the RGLS8429 program .

Q&A Highlights

  • No Q3’24 earnings call transcript was found; therefore, no Q&A summary is available. Management commentary herein is drawn from the press releases and 8‑K furnishing .

Estimates Context

  • S&P Global consensus estimates for Q3’24 were unavailable for RGLS at this time, so no quantitative comparison to Street expectations is provided. As a development‑stage company with no reported revenue line, quarterly “beats/misses” are typically less relevant than clinical/regulatory milestones .

Key Takeaways for Investors

  • Clinical execution remains the core driver: cohort 4 enrollment completed; early‑2025 topline from a substantial number of patients and EoP1 by year‑end 2024 are the next catalysts .
  • Mechanistic consistency and exploratory efficacy signals (PC1/PC2 increases; 70% htTKV reductions at 3 mg/kg in cohort 3) de‑risk biological activity ahead of later‑stage studies .
  • Rising operating expenses are an intentional investment behind RGLS8429; net losses widened accordingly, a pattern likely to persist as development advances .
  • Liquidity appears sufficient into H1 2026, supporting execution through EoP1 and initial cohort 4 readout without near‑term financing needs, barring expanded development plans .
  • IP strengthening via the UTSW license underscores strategic positioning in miR‑17 targeting for ADPKD, potentially enhancing long‑term optionality .
  • Near‑term trading setup is catalyst‑driven (EoP1 outcome, early‑2025 topline); in absence of Street estimates and a call transcript, investor focus should remain on clinical data quality, FDA feedback, and cash runway .

Additional source documents read:

  • Q3’24 8‑K Item 2.02 and Exhibit 99.1 press release .
  • Q3’24 standalone press release (PR Newswire) .
  • Q2’24 8‑K and press release .
  • Q1’24 8‑K and press release .
  • Q4/Oct. 8, 2024 cohort 4 enrollment completion press release .