EB
Evelo Biosciences, Inc. (EVLO)·Q2 2022 Earnings Summary
Executive Summary
- Pre-revenue biotech quarter with disciplined OpEx and pipeline milestones; net loss was $30.6M (EPS $(0.40)), modestly improved vs prior year on a per-share basis due to higher share count after the May financing .
- Cash rose to $92.0M at 6/30 from $39.6M at 3/31 on proceeds from a $79.2M registered direct offering in May; management reiterated cost control focus to extend runway .
- Guidance sharpened: EDP1815 psoriasis regulatory feedback by year-end 2022; atopic dermatitis Phase 2 readouts in Q1 and Q2 2023; EDP2939 Phase 1/2 start in Q3 2022 with dosing in Q4 and psoriasis data in 2H 2023 .
- Potential stock catalysts: CEO succession announcement, EDP1815 AD data cadence, psoriasis registrational design feedback, and initiation/dosing for EDP2939 (first EV candidate) .
What Went Well and What Went Wrong
-
What Went Well
- Strengthened balance sheet: cash increased to $92.0M at quarter-end after a $79.2M financing; added an experienced CFO effective Sept 1, 2022 .
- Clinical execution on track: AD Phase 2 recruitment “on-schedule”; two AD readouts guided for Q1 and Q2 2023; psoriasis feedback from regulators expected by year-end 2022 .
- Strategic clarity on formulation: management highlighted potential of faster-release capsule to enhance efficacy and will use Cohort 4 AD readout to inform psoriasis Phase 3 formulation choice .
-
What Went Wrong
- Continued losses with no revenue; Q2 net loss of $30.6M and total OpEx of $29.6M underscore ongoing cash burn typical for clinical-stage biotech .
- Rising G&A year over year (Q2: $8.4M vs $7.0M), reflecting growth needs ahead of late-stage development; R&D also edged up (Q2: $21.2M vs $20.7M) .
- Estimates context unavailable: S&P Global consensus for EVLO could not be retrieved; thus we cannot quantify beats/misses this quarter (pre-revenue stage) (S&P Global consensus data unavailable for this ticker at time of retrieval).
Financial Results
Notes: EVLO reported no revenue line in its statements of operations for these periods; treated as $0 revenue .
Cash and Debt
Estimates vs. Actuals
S&P Global consensus estimates were unavailable for EVLO at the time of retrieval; therefore beats/misses cannot be assessed.
Segment breakdown and operating margins are not applicable given no revenue recognition.
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “Enrollment is progressing well in the first three cohorts of the Phase 2 trial for EDP1815 in atopic dermatitis… [and] a fourth cohort… with a faster release profile… is expected to read out in the second quarter of 2023.”
- “We… are waiting on guidance for advancing EDP1815 into registration trials [in psoriasis]… by year-end.”
- On cost control: “We… looked at critical areas of investment… already taken a number of measures to bring cost under control in a very disciplined manner.”
- On formulation strategy: “Base plan is to go forward with the original formulation… If we see a substantive improvement in… Cohort 4 in atopic dermatitis, then we will use that in the Phase 3 in psoriasis.”
- On EVs: “Best case, we could get antibody-like efficacy with the microbial extracellular vesicles… the preclinical data supports that as a possibility.”
Q&A Highlights
- Capital preservation/runway: Management reiterated prior cost cuts and focus on core programs to ensure cash lasts through key 2023 catalysts .
- Psoriasis Phase 3 design: Planning to proceed with once-daily original formulation unless the faster-release Cohort 4 in AD shows clear improvement; regulators to confirm Phase 3 design and CMC readiness .
- AD efficacy bar: EASI50 is key; “20% or greater separation… versus placebo would be a very strong win,” 15–20% a gray zone .
- EV candidate segmentation: If EV efficacy is high, could segment severe patients vs keeping EDP1815 for mild-moderate; awaiting data to decide .
- Commercial insights: Strong patient/clinician preference for oral therapy (Otezla as proof point) and intent for “very reasonable pricing” to drive volume .
Estimates Context
- Wall Street consensus (S&P Global) for Q2 2022 revenue and EPS was unavailable for this ticker at the time of retrieval; as a pre-revenue biotech, reported revenue was $0 and EPS $(0.40). This limits beat/miss assessment based on consensus .
- Implications: Absent consensus anchors, investor focus remains on OpEx trends, cash runway, and 2023 clinical catalysts rather than near-term P&L beats/misses.
Key Takeaways for Investors
- Cash runway extended by May financing; management is tightly prioritizing spend to reach multi-quarter 2023 catalysts (AD Phase 2 readouts, psoriasis registrational design, EV first-in-human) .
- Formulation strategy offers upside optionality: faster-release capsule could boost efficacy, with a data-informed pivot available ahead of psoriasis Phase 3 without timeline slippage .
- Multiple near-term catalysts: regulatory feedback by year-end 2022, AD readouts in Q1/Q2 2023, EDP2939 dosing in Q4 2022 and data in 2H 2023—each a potential stock mover .
- Commercial thesis reinforced: strong preference for oral options and intent for reasonable pricing suggests large mild/moderate populations are addressable if efficacy clears the AD “20% separation” bar and psoriasis endpoints .
- Leadership transition is underway (CEO succession; new CFO), but continuity is emphasized; watch for any strategic pivots as a new CEO is appointed .
- With no revenue and ongoing losses, valuation will key off clinical probability of success, formulation-enhanced efficacy, and partnering optionality discussed by management in prior periods .
Citations:
- Q2 2022 8-K press release and financials:
- Q2 2022 earnings call transcript:
- Q1 2022 8-K press release and financials:
- Q4 2021 8-K press release and financials: