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EP

Eloxx Pharmaceuticals, Inc. (ELOX)·Q3 2022 Earnings Summary

Executive Summary

  • Q3 2022 delivered operational progress (Alport Phase 2 PoC initiated) with narrowed losses: net loss of $7.5M ($0.09 EPS) vs $9.9M in Q3 2021; cash and equivalents ended at $24.6M .
  • Management reiterated cash runway into Q4 2023, contingent on maintaining minimum cash covenant or restructuring with lender; company remained in compliance at quarter end .
  • Pipeline milestones were emphasized: Alport topline in H1 2023; ZKN-013 IND for RDEB by end-2022/early-2023; inhaled ELX-02 IND enabling studies continuing; CF combination study did not meet efficacy endpoints, informing higher lung exposure/inhaled path .
  • Street consensus (S&P Global) for Q3 2022 EPS and revenue was unavailable; estimate-based beat/miss analysis cannot be performed. S&P Global consensus unavailable.

What Went Well and What Went Wrong

What Went Well

  • Initiated proof-of-concept Phase 2 in Alport syndrome; topline expected H1 2023. Quote: “With the recent start of our Phase 2 proof-of-concept trial for ELX-02… we are on track to deliver topline results… in the first half of 2023.” — Sumit Aggarwal, CEO .
  • Ongoing advancement of RMA platform with new oncology posters (MYC-driven cancers, colorectal subtypes ZKN-157, SCLC ZKN-217), and selective hits from phenotypic screens .
  • Operating discipline: Q3 R&D fell to $4.9M and G&A to $2.3M (down sharply YoY), contributing to lower net loss vs prior year .

What Went Wrong

  • CF Phase 2 combination study with ivacaftor did not meet efficacy endpoints, necessitating focus on higher lung exposure and potential inhaled delivery path .
  • Cash declined sequentially ($24.6M vs $30.0M in Q2), and runway is contingent on covenant maintenance or restructuring, highlighting financing and covenant risks .
  • No product revenue and continuing operating losses; accumulated deficit reflected in negative stockholders’ equity at Q3 ($-5.0M) .

Financial Results

MetricQ1 2022Q2 2022Q3 2022
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$11.62 $10.62 $7.51
Diluted EPS ($USD)$0.13 $0.12 $0.09
R&D Expense ($USD Millions)$7.90 $7.65 $4.88
G&A Expense ($USD Millions)$3.05 $2.65 $2.26
Cash and Equivalents ($USD Millions, period-end)$39.77 $30.05 $24.55
Weighted Avg Shares (Millions)86.65 86.65 86.66

Notes:

  • Company reported no product revenue; statements present only operating expenses and loss from operations .
  • Cash runway guidance: “sufficient to fund our operations into the fourth quarter of 2023” subject to covenant compliance or restructuring .

Segment breakdown: Not applicable (no revenue segments reported) .

KPIs

KPIQ1 2022Q2 2022Q3 2022
Current Portion of Long-term Debt ($USD Millions)— 1.13 2.53
Long-term Debt (net of current) ($USD Millions)12.12 11.13 9.86
Advances from Collaboration Partners ($USD Millions)10.72 10.72 12.22
Stockholders’ Equity ($USD Millions)11.69 1.81 -4.98

Guidance Changes

MetricPeriodPrevious Guidance (Q2 2022)Current Guidance (Q3 2022)Change
Cash RunwayThrough Q4 2023Sufficient to fund operations into Q4 2023 if lender does not accelerate upon failure to comply with minimum cash covenant Sufficient to fund operations into Q4 2023 assuming compliance or lender covenant restructuring; in compliance at 9/30/22 Clarified covenant dependency (maintained)
ELX-02 Alport Phase 2 PoCStart / ToplineInitiate H2 2022; topline H1 2023 Started; topline H1 2023 Achieved start; timeline maintained
ZKN-013 (RDEB) INDTimingIND in Q4 2022 IND by end-2022 or early 2023 Slightly widened window
Inhaled ELX-02 INDTimingIND in Q4 2022; preclinical modeling suggests ≥50-fold lung exposure vs SC IND-enabling ongoing; path forward in CF to be determined with CF Foundation Timing more cautious; pathway under review
CF ELX-02 + IvacaftorReadout / EfficacyTopline by end of Q3 2022 Did not meet efficacy endpoints; confirms drug activity; need higher lung exposure Negative efficacy update

Earnings Call Themes & Trends

(Transcript not found for Q3 2022; themes derived from press releases.)

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
CF Program (ELX-02)Q1: CF Foundation award up to $15.9M; combo with Kalydeco ongoing; inhaled IND H2 2022 . Q2: Topline expected by end Q3 2022; inhaled delivery modeled ≥50x lung exposure .Combo study did not meet efficacy endpoints; drug activity confirmed; focus on higher lung exposure via inhaled; path with CF Foundation to be determined .Pivot to inhaled strategy; de-risked combo efficacy outlook
Alport Syndrome (ELX-02)Q1/Q2: Plan to initiate H2 2022; topline H1 2023 .Phase 2 PoC started; topline H1 2023; poster presented at ASN Kidney Week .Executing per plan; momentum maintained
ZKN-013 (RDEB/FAP)Q1: FIH Phase 1 in 2022; FAP preclinical data (APC Min) encouraging . Q2: IND RDEB in Q4 2022; repeat APC Min study confirmed prior findings; FAP IND H2 2023 .IND RDEB by end-2022 or early 2023; continuing FAP IND prep .Slight timing shift; continued progress
RMA Platform/OncologyQ1/Q2: Platform expansion underway .New posters in MYC-driven cancers; selective hits via phenotypic screen .Growing breadth of indications
Cash/CovenantsQ1: Cash $39.8M; runway into Q2 2023 . Q2: Cash $30.0M; runway into Q4 2023 subject to covenant .Cash $24.6M; runway into Q4 2023 assuming compliance/restructuring; compliant at Q3 end .Runway reiterated; covenant sensitivity highlighted

Management Commentary

  • “With the recent start of our Phase 2 proof-of-concept trial for ELX-02… we are on track to deliver topline results for the program in the first half of 2023.” — Sumit Aggarwal, President & CEO .
  • “We have also made significant advancements in our Ribosome Modulating Agents programs, approaching clinical development for ZKN-013 for the treatment of RDEB and generating encouraging preclinical data in multiple indications.” — Sumit Aggarwal .
  • CF update: “A Phase 2 combination study… did not meet efficacy endpoints but did confirm drug activity for ELX-02 and demonstrated need for higher drug exposure in lung… Eloxx aims to complete IND enabling studies for inhaled ELX-02.” .

Q&A Highlights

  • Q3 2022 earnings call transcript could not be located; no Q&A highlights available.

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2022 EPS and revenue was unavailable due to missing SPGI mapping for ELOX; estimate-based beat/miss assessment cannot be completed. S&P Global consensus unavailable.

Key Takeaways for Investors

  • Near-term catalysts: Alport Phase 2 PoC topline in H1 2023; potential IND submissions (ZKN-013 for RDEB end-2022/early-2023; inhaled ELX-02 path under review)—these events can drive sentiment and stock movement .
  • CF readthrough remains mechanistically active; failure to meet combo efficacy endpoints refocuses value on inhaled delivery and lung exposure—watch IND-enabling progress and CF Foundation decisions .
  • Operating discipline improved P&L: lower R&D and G&A versus prior quarter/year; net loss narrowed to $7.5M and EPS to $0.09, easing cash burn rate .
  • Balance sheet/covenant watch: cash fell to $24.6M; runway contingent on minimum cash covenant or restructuring with lender; management reported covenant compliance at Q3-end .
  • RMA platform/oncology signals optionality beyond CF/Alport (MYC-driven cancers, colorectal, SCLC)—early, but expands potential TAM and partnership optionality .
  • Collaboration advances (advances from partners $12.22M) and CF Foundation support help fund development; monitor milestone-triggered tranches and any partnering updates .
  • No Street estimates available; in absence of “beat/miss,” trading may anchor to pipeline milestones and financing trajectory rather than near-term financial metrics. S&P Global consensus unavailable.

Additional Documents Read

  • Q3 2022 8-K 2.02 and press release (Exhibit 99.1) .
  • Q2 2022 8-K and press release (Exhibit 99.1) .
  • Q1 2022 8-K and press release (Exhibit 99.1) .

Other relevant press releases in Q3 2022: None found beyond the Q3 earnings press release .