Executive Summary

Clean quarter operationally with no revenue, sequentially lower operating expenses ($6.07m) and narrower net loss ($5.85m), aided by lower G&A vs Q2; cash ended at $17.65m and runway guided “into June 2025.”
Clinical narrative strengthened: combined Cohort 1+2 for LTI-03 achieved statistical significance in 4/8 biomarkers; Cohort 2 (5 mg BID) showed dose-dependent effects in 5 biomarkers and a 5% reduction in SPD over 14 days, supporting progression to Phase 2 planning.
Corporate update: exclusive option agreement with Advancium Health Network for ALRN-6924 could provide future non-dilutive proceeds if exercised; no near-term P&L impact disclosed.
No Q3 earnings call transcript was available; a separate Nov 13 data call focused on LTI-03 Cohort 2 results and included no Q&A.
Street estimates (S&P Global) were unavailable; results should be viewed vs internal spend trajectory and clinical milestones rather than consensus EPS/revenue. (S&P Global estimates unavailable)

What Went Well and What Went Wrong

What Went Well

LTI-03 clinical signal strengthened: Cohort 2 demonstrated dose-dependent effects in five biomarkers (e.g., COL1A1, CXCL7, TSLP, GAL7, SPD), with statistical significance in three biomarkers; combined Cohort 1+2 reached significance in four biomarkers, supporting Phase 2 planning. “This past quarter has been one of significant progress…” — CEO Brian Windsor.
Safety profile reinforced: pAKT (safety biomarker) showed no activation in PBMCs in either cohort; SPD fell ~5% over 14 days in Cohort 2, a directionally favorable epithelial-health signal and an emerging plasma KPI for future trials.
Operating discipline sequentially improved: G&A dropped to $2.35m vs $5.30m in Q2, driving lower total OpEx ($6.07m vs $9.04m) and a narrower net loss ($5.85m vs $8.94m).

What Went Wrong

Cash runway narrowed from “into H2’25” (Q1/Q2) to “into June 2025,” largely reflecting increased R&D activity and manufacturing write-offs tied to a temporary delay in LTI-01 clinical development ($0.8m in Q3).
YoY cost base stepped up with Lung Therapeutics programs: R&D rose to $3.72m vs < $0.1m in Q3’23; G&A modestly higher YoY ($2.35m vs $1.96m).
No revenue and limited external estimate coverage persist, reducing traditional “beat/miss” catalysts and placing more weight on clinical data disclosures and financing cadence.

Financial Results

Summary P&L and Liquidity (USD $ thousands, except per share)

Metric	Q1 2024	Q2 2024	Q3 2024
Revenue	$0	$0	$0
Research & Development	$3,463	$3,741	$3,722
General & Administrative	$3,742	$5,298	$2,349
Total Operating Expenses	$7,205	$9,039	$6,071
Net Loss	$(7,113)	$(8,942)	$(5,847)
Diluted EPS	$(0.86)	$(0.45)	$(0.27)
Cash & Cash Equivalents (end of period)	$12,042	$21,917	$17,652

Q3 2024 YoY Comparison (USD $ thousands, except per share)

Metric	Q3 2023	Q3 2024
Revenue	$0	$0
Research & Development	<$100	$3,722
General & Administrative	$1,955	$2,349
Total Operating Expenses	$1,983	$6,071
Net Loss	$(1,827)	$(5,847)
Diluted EPS	$(0.40)	$(0.27)

R&D Spend Mix (management disclosure, USD $ millions)

R&D Component	Q1 2024	Q2 2024	Q3 2024
Clinical trials	$1.1	$1.1	$2.1
Manufacturing	$1.6	$2.0	$1.0 (incl. $0.8 write-offs, LTI-01 delay)
Regulatory & development consulting	$0.2	$0.1	$0.1
Employee & related	$0.6	$0.5	$0.5

Notes: No revenue segments to report; company remains clinical-stage.

Actual vs Estimates

Metric	Actual (Q3 2024)	Consensus (S&P Global)	Surprise
Revenue	$0	Unavailable (no S&P Global consensus)	N/A
Diluted EPS	$(0.27)	Unavailable (no S&P Global consensus)	N/A

S&P Global consensus estimates were unavailable for ALRN for Q3 2024; comparisons to Street estimates cannot be made. (S&P Global estimates unavailable)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	FY2025	“Into the second half of 2025” (Q1/Q2 disclosures)	“Into June 2025” (Q3)	Narrowed/shortened
LTI-03 development	2024-2025	Phase 1b Cohort 2 topline expected Q3’24 (Q1/Q2)	Phase 2 planning underway (post Cohort 2 data)	Progressed to planning
Corporate BD (ALRN-6924)	2024-2025	N/A	Exclusive option agreement with Advancium; potential exercise/milestones/royalties if option exercised	New optionality (no quantified guidance)

No quantitative revenue/OpEx/EPS guidance provided.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2, Q1)	Current Period (Q3 2024)	Trend
LTI-03 biomarkers/efficacy rationale	Cohort 1: positive trend in 7/8 biomarkers; 3 statistically significant; safety clean; Cohort 2 topline expected Q3’24.	Cohort 2: dose-dependent effects in 5 biomarkers; 3 significant; combined 4/8 significant; SPD down ~5%; Phase 2 planning underway.	Improving evidence; moving toward Phase 2
Safety (pAKT)	Clean safety signal noted in Cohort 1; no SAEs.	pAKT not activated in Cohort 1 or 2; continued tolerability.	Stable positive
Cash runway/capital	Q1: runway into H2’25; Q2: runway into H2’25 post $18.2m raise.	Runway guided to June 2025; cash $17.65m at 9/30.	Slightly shorter runway
LTI-01 program	In development for LPE; no near-term readouts; ongoing work.	Temporary clinical delay caused $0.8m manufacturing write-offs.	Timing/regulatory work re-sequenced
Corporate development (ALRN-6924)	N/A	Entered exclusive option with Advancium for retinoblastoma use; potential milestones/royalties.	New monetization optionality

Note: No Q3 earnings-call transcript available; a Nov 13 data-call transcript focused on Cohort 2 contained no Q&A.

Management Commentary

“This past quarter has been one of significant progress for Aileron… high dose LTI-03 demonstrated dose dependent effects in five biomarkers… the combined data set from Cohort 1 and 2 achieved statistical significance in four out of eight biomarkers… [which] reinforce the potential of LTI-03 to improve lung function and reverse the course of the disease.” — Brian Windsor, President and CEO.
“We observed dose-dependent effects of LTI-03 in Cohort 2… statistical significance of 3 biomarkers… combined data set showed even stronger results with 4… LTI-03 demonstrated a 5% decrease in SPD after a 14-day treatment course… We believe that the results… support advancement to a Phase II study.” — Brian Windsor, data call.
“pAKT… was not activated in PBMCs at either cohort… We believe that LTI-03 could meaningfully impact the current treatment paradigm.” — Brian Windsor, data call.

Q&A Highlights

No Q3 earnings-call transcript was available in the document set; the Nov 13 data call concluded without questions from participants.

Estimates Context

S&P Global consensus estimates for Q3 2024 revenue and EPS were unavailable for ALRN; as a clinical-stage micro-cap with no revenue, coverage appears limited (no consensus to benchmark). (S&P Global estimates unavailable)
Implication: investor focus remains on clinical catalysts, spend trajectory, cash runway, and potential BD optionality rather than quarterly “beats/misses.”

Key Takeaways for Investors

Clinical momentum: Cohort 2 delivered dose-dependent biomarker moves and added SPD reduction, and combined cohorts achieved significance in 4/8 biomarkers, strengthening the probability of advancing to Phase 2.
Safety intact: No pAKT activation in either cohort; tolerability profile supportive of continued development.
Spending disciplined sequentially: G&A and total OpEx declined from Q2, narrowing the quarterly loss; cash ended Q3 at $17.65m.
Runway recalibration: Guidance shifted from “H2’25” to “June 2025,” emphasizing the need to sequence Phase 2 plans with financing optionality (potential warrant exercises/B.D.).
LTI-01 re-sequencing: Temporary clinical delay resulted in $0.8m manufacturing write-offs; watch for updates on timing and strategy.
BD optionality: Exclusive option with Advancium for ALRN-6924 creates potential non-dilutive proceeds if exercised and milestones achieved.
Trading setup: With no Street estimates and no revenue, stock direction likely keyed to Phase 2 initiation timing/design, further biomarker validation, and capital updates; near-term catalysts include protocol disclosures and regulatory interactions for Phase 2.

Additional Relevant Press Releases (Q4 reporting window for Q3 period)

Positive topline data from Cohort 2 announced Nov 13 (reinforced in Q3 8-K press release summary).
Exclusive option agreement with Advancium announced Oct 31 (summarized in Q3 press release).

Prior Quarter References (for trend)

Q2 2024: Positive Cohort 1 biomarker data (3/8 significant), $21.9m cash, runway into H2’25; G&A elevated on integration costs.
Q1 2024: Raised ~$20m gross (subsequent), Cohort 1 signals communicated, runway into H2’25, cash $12.0m at 3/31.

Aileron Therapeutics, Inc. (ALRN)·Q3 2024 Earnings Summary