Executive Summary

EVLO reported Q3 2022 net loss of $30.6M and EPS of $(0.28), with R&D of $21.9M and G&A of $7.1M; cash and equivalents were $69.1M at quarter-end, down from $92.0M in Q2 after Q2 financing, reflecting burn to fund pipeline progress .
Regulatory momentum in psoriasis advanced: EMA and MHRA gave supportive feedback on proposed registration trial design; initial FDA feedback received with a meeting requested, de-risking path to pivotal trials .
Key 2023 catalysts reiterated: EDP1815 atopic dermatitis Phase 2 Cohorts 1–3 data early Q1, Cohort 4 (faster-release) in Q2, and first EV product candidate EDP2939 Phase 2 in psoriasis in 2H 2023; MHRA requested additional CTA information for EDP2939, pushing initial dosing into Q1 2023 .
No Wall Street consensus estimates (EPS, revenue) available via S&P Global for EVLO this quarter due to a mapping issue; consequently, no beat/miss determination versus estimates can be made [SpgiEstimatesError].

What Went Well and What Went Wrong

What Went Well

EMA and MHRA supported EVLO’s proposed registration trial design for EDP1815 in psoriasis, including endpoints and CMC, marking substantive regulatory progress toward pivotal studies .
Atopic dermatitis Phase 2 execution remained strong: recruitment completed for Cohorts 1–3; Cohort 4 recruitment ahead of schedule with a faster-release capsule targeting upper small intestine, aiming for greater efficacy .
EDP1815’s platform narrative emphasized broad anti-inflammatory effects (Th1/Th2/Th17) with placebo-like safety/tolerability and affordability potential, positioning as foundational therapy across disease severities, per CEO remarks .

What Went Wrong

Cash declined to $69.1M from $92.0M in Q2 as operating burn continued; net loss remained elevated at $30.6M, underscoring ongoing funding needs typical for clinical-stage biotech .
EDP2939 timeline slipped: MHRA requested additional CTA information; dosing now anticipated in Q1 2023 rather than Q4 2022, modestly pushing the EV psoriasis program .
No Q3 earnings call transcript available in our document set, limiting real-time management Q&A insights for the quarter; reliance on press release and prior quarter call commentary for qualitative color [ListDocuments: 0 results for Q3 call].

Financial Results

Metric	Q1 2022	Q2 2022	Q3 2022
Cash and Equivalents ($USD Millions)	$39.6	$92.0	$69.1
Research & Development Expense ($USD Millions)	$19.3	$21.2	$21.9
General & Administrative Expense ($USD Millions)	$9.4	$8.4	$7.1
Total Operating Expenses ($USD Millions)	$28.7	$29.6	$29.1
Loss from Operations ($USD Millions)	$(28.7)	$(29.6)	$(29.1)
Net Loss ($USD Millions)	$(29.9)	$(30.6)	$(30.6)
EPS, Basic & Diluted ($USD)	$(0.56)	$(0.40)	$(0.28)
Weighted-Average Shares (Basic & Diluted)	53,619,635	75,719,092	108,051,851

Notes:

EVLO did not report product revenue; financials are dominated by operating expenses and losses .
No consensus estimates available via S&P Global; therefore, no vs-estimates comparison can be provided this quarter [SpgiEstimatesError].

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
EDP1815 AD Phase 2 Cohorts 1–3 data	Early Q1 2023	Data anticipated in Q1 2023	Data expected early Q1 2023	Maintained
EDP1815 AD Phase 2 Cohort 4 (faster-release) data	Q2 2023	Data anticipated in Q2 2023	Data expected in Q2 2023	Maintained
EDP2939 Psoriasis Phase 2 data	2H 2023	Data expected 2H 2023	Data anticipated 2H 2023	Maintained
EDP2939 CTA/dosing start	Initially Q4 2022	Initiation in Q3 2022; dosing expected Q4 2022	MHRA requested info; dosing anticipated Q1 2023	Lowered (timeline slipped)
EDP1815 Psoriasis registration trial feedback	By year-end 2022	Expect feedback by year-end 2022	EMA/MHRA supportive; initial FDA feedback received; meeting requested	Achieved milestone (EU/UK), progressing (US)

No explicit financial guidance (revenue, margins, OpEx totals, tax rate, dividends) was provided in Q3 materials .

Earnings Call Themes & Trends

Note: No Q3 2022 call transcript found; themes below track evolution from Q1 to Q2 alongside Q3 press release commentary.

Topic	Q1 2022 (Prior-2)	Q2 2022 (Prior-1)	Q3 2022 (Current)	Trend
Psoriasis registration pathway	Advancing EDP1815 toward later-stage trials; faster-release capsule highlighted	Expect health authority feedback by year-end	EMA/MHRA supportive on design/endpoints; initial FDA feedback; meeting requested	Positive progression toward pivotal
Atopic dermatitis Phase 2 progress	Recruitment ahead of plan; added potential 4th cohort	Cohorts 1–3 on-schedule; added Cohort 4 faster-release	Cohorts 1–3 recruitment complete; Cohort 4 ahead of schedule	Execution strong; timelines intact
EDP2939 (EV) psoriasis	Clinical initiation planned Q3 2022	Initiation Q3; dosing expected Q4 2022	MHRA requested info; dosing now anticipated Q1 2023	Modest delay; still targeting 2H 2023 data
Financing and cash	Cash $39.6M at Q1-end	$79.2M registered direct offering completed; cash $92.0M	Cash $69.1M at Q3-end	Raise then burn; runway management critical
Leadership	Board/advisors additions	CFO appointment effective Sep 1; CEO succession plan announced; Chair remarks	No new leadership changes disclosed in Q3 PR	Transition underway
Cost control focus	—	Management emphasized disciplined cost controls in Q&A	Not discussed in Q3 PR	Ongoing focus (inferred from Q2)
Pricing and market strategy	—	Oral demand and volume-driven pricing strategy positioning vs Otezla	—	Strategic stance consistent (from Q2)

Management Commentary

“We are on-track to deliver on three Phase 2 clinical milestones throughout 2023… data from the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis [early Q1],… data from the fourth cohort… [Q2],… and… data… in the Phase 2 trial of EDP2939… [2H 2023].” – CEO Simba Gill .
“EMA and MHRA… acknowledged the appropriateness of our proposed registration clinical trial design for EDP1815 in psoriasis… We have also received initial written feedback from the FDA… and have requested a meeting…” – CEO Simba Gill .
“Given the integrated profile of EDP1815, which is not just effective, but also has placebo-like safety and tolerability, oral delivery and affordable pricing, we anticipate broad usage as a foundational therapy…” – CEO Simba Gill (Q2 call) .

Q&A Highlights

Capital preservation and cost controls: Management had already implemented disciplined cost measures and prioritized core programs to align with cash runway in the current environment .
Psoriasis Phase 3 design/formulation: Base plan is original once-daily formulation; faster-release capsule adoption in Phase 3 contingent on Cohort 4 AD data showing improved efficacy, with no expected timeline impact .
AD efficacy bar: EASI50 separation of ≥20% versus placebo would be a “clear win”; 15–20% considered a gray zone; safety expected to remain strong .
EDP2939 efficacy expectations: EVs may achieve higher potency than whole microbes due to better small intestine access; ambition is antibody-like efficacy in a majority of patients, potentially segmenting with 1815 in mild/moderate and EV candidate in more severe populations depending on data .
Durability: Noted durability and deepening of response post-dosing; hypothesis centered on modulation of circulating regulatory T-cell subpopulations; plans for longer-duration and open-label extensions to assess maintenance .

Estimates Context

S&P Global consensus estimates for Q3 2022 (EPS and revenue) were unavailable due to a CIQ mapping issue for EVLO; as a result, we cannot determine beats/misses vs Wall Street estimates this quarter [SpgiEstimatesError].
Given no product revenue reported and operating loss profile, future estimate adjustments will likely be driven by clinical timeline shifts (e.g., EDP2939 dosing move to Q1 2023) and OpEx run-rate disclosures .

Key Takeaways for Investors

Regulatory de-risking in psoriasis: EMA/MHRA supportive design feedback and initial FDA engagement materially improve visibility toward registration trials; watch for FDA meeting outcomes as a potential catalyst .
2023 catalyst cadence intact for EDP1815 (AD) with Cohorts 1–3 in early Q1 and Cohort 4 in Q2; positive Cohort 4 data could upgrade Phase 3 formulation choice and strengthen efficacy narrative .
EDP2939 (EV) modestly delayed to Q1 dosing; still aiming for 2H 2023 data—monitor timeline adherence and initial healthy volunteer safety/tolerability .
Cash dynamics: Post-Q2 financing, cash fell to $69.1M by Q3; continued burn underscores importance of disciplined OpEx and potential future financing ahead of pivotal trials .
Positioning vs oral competitors: Management’s volume-driven pricing strategy and safety/tolerability differentiation target broad mild/moderate segments, potentially expanding market access relative to higher-priced or less-tolerable orals .
Stock-relevant narrative: Near-term bidirectional risk around regulatory feedback and AD readouts; upside if faster-release capsule shows superior efficacy and FDA aligns on registration path; downside if efficacy bars not met or timelines slip .
No estimates comparison this quarter due to data unavailability; watch for future consensus formation post-major readouts and regulatory milestones to recalibrate expectations [SpgiEstimatesError].

Appendix: Source Documents Read

Q3 2022 8-K press release with financial statements and regulatory/business updates .
Q2 2022 8-K press release and full earnings call transcript for trend analysis .
Q1 2022 8-K press release for trend analysis .

S&P Global consensus estimates were attempted but unavailable due to CIQ mapping error; no estimates are presented for Q3 2022 [SpgiEstimatesError].

Evelo Biosciences, Inc. (EVLO)·Q3 2022 Earnings Summary