Executive Summary

FYARRO net product sales reached $7.2M in Q3 2024, up 17% QoQ and 21% YoY, with management highlighting a “nearly 90 percent reorder rate,” while net loss improved to $12.5M and total operating expenses declined versus prior year .
Cash, cash equivalents and short-term investments totaled $62.6M; the company extended cash runway guidance to at least 2H 2026 following restructuring and pipeline actions .
A comprehensive strategic review is ongoing; PRECISION1 was halted after a 2/3 interim analysis indicated it was unlikely to meet the threshold for accelerated approval, shifting focus to FYARRO commercialization and near-term EEC/NET signals later in 2024 .
Near-term catalysts: initial efficacy signals from Phase 2 EEC (n=24) and NET (n=12) later in 2024; strategic update timing not specified .

What Went Well and What Went Wrong

What Went Well

Strong commercial execution: “The third quarter saw strong sales growth for FYARRO … and a nearly 90 percent reorder rate,” underpinning $7.2M FYARRO net sales (+17% QoQ; +21% YoY) .
Operating discipline: Total operating expenses fell to $20.6M vs $23.8M prior-year quarter; net loss improved to $12.5M from $16.3M .
Liquidity and runway: Cash/short-term investments at $62.6M; guidance extended to at least 2H 2026 after restructuring and prioritization .

What Went Wrong

Pipeline setback: PRECISION1 halted after DMC review indicated it would not exceed the efficacy threshold for accelerated approval; R&D headcount reduced ~80% and enrollment paused in EEC/NET (continue dosing), reflecting a narrower development scope .
Restructuring costs: Q3 included $2.6M restructuring charges, impacting OpEx in the period .
Customer concentration: Two customers represented 54% and 44% of Q3 revenue, highlighting concentration risk in the channel .

Financial Results

Quarterly progression (oldest → newest)

Metric	Q1 2024	Q2 2024	Q3 2024
Revenue ($USD Millions)	$5.353	$6.179	$7.212
Net Loss ($USD Millions)	$(18.289)	$(14.583)	$(12.546)
Net Loss per Share ($USD)	$(0.68)	$(0.54)	$(0.46)
Total Operating Expenses ($USD Millions)	$24.865	$21.763	$20.625
Cost of Goods Sold ($USD Millions)	$0.652	$0.778	$0.804
Loss from Operations ($USD Millions)	$(19.512)	$(15.584)	$(13.413)
Operating Margin %	(364.5%)	(252.2%)	(185.8%)

Year-over-year comparison

Metric	Q3 2023	Q3 2024
Revenue ($USD Millions)	$5.959	$7.212
Net Loss ($USD Millions)	$(16.302)	$(12.546)
Net Loss per Share ($USD)	$(0.60)	$(0.46)
Total Operating Expenses ($USD Millions)	$23.808	$20.625
Cost of Goods Sold ($USD Millions)	$0.697	$0.804
Operating Margin %	(299.5%)	(185.8%)

KPIs and balance sheet items

KPI/Metric	Q1 2024	Q2 2024	Q3 2024
FYARRO Reorder Rate (%)	N/A	N/A	~90%
Ordering Accounts Since Launch (#)	>200 (cumulative)	>200	>200 (context)
Cash, Cash Equivalents & Short-term Investments ($USD Millions)	$88.3	$78.6	$62.6
Gross-to-net Allowances (QTD, $USD Millions)	N/A	N/A	$1.7
Customer Concentration (% of revenue, top two)	N/A	N/A	54% and 44%

Note: Aadi reports a single revenue stream (FYARRO net sales); no segment breakdown disclosed .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Into Q4 2025	Into at least 2H 2026	Raised/Extended
PRECISION1 (Tumor-agnostic, TSC1/TSC2)	Q3 2024 / 2025	2/3 interim analysis planned Q3 2024; full results early 2025	Trial halted; expanded access; report in 2025	Lowered/Terminated
EEC (Endometrioid-type Endometrial Cancer)	2024	Initial data later in 2024 (ongoing enrollment)	Enrollment paused; continue dosing; n=24; initial signals later in 2024	Maintained timing; scope reduced
NET (Neuroendocrine Tumors)	2024	Initial data later in 2024 (ongoing enrollment)	Enrollment paused; continue dosing; n=12; initial signals later in 2024	Maintained timing; scope reduced
Revenue/EPS	Q3 onward	None provided	None provided	Maintained (no formal guidance)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2 2024)	Current Period (Q3 2024)	Trend
PRECISION1 path to accelerated approval	Q1/Q2 emphasized fully-enrolled trial, 2/3 interim in Q3; potential FDA path if results hold	DMC concluded trial unlikely to meet threshold; halted; results in 2025	Deteriorated materially
FYARRO commercial demand	Q1 softness (distributor patterns; clinical “cannibalization”), Q2 rebound and +15% QoQ sales	Q3 +17% QoQ; 21% YoY; ~90% reorder rate; demand strong	Improving
Strategic alternatives	Not discussed in Q1/Q2	Comprehensive strategic review ongoing; timing unspecified	New development
Cash runway	Into Q4 2025	Into at least 2H 2026	Improved via restructuring
EEC/NET programs	Initial data targeted for late 2024; strong interest; Simon’s two-stage design (EEC ≥20% ORR benchmark)	Enrollment paused; continue dosing; sufficient n to assess initial signals later 2024	Cautious; scope reduced
Legal/regulatory	Mirati combo terminated to focus investment	Arbitration win vs. EOC; no damages	Resolved positively
Supply chain/macro	N/A specific in calls	Ongoing monitoring; no current material impacts disclosed	Stable/monitored

Management Commentary

“The third quarter saw strong sales growth for FYARRO, backed by continued account momentum, increased demand and a nearly 90 percent reorder rate – all reinforcing the clinical value of FYARRO for patients with advanced malignant PEComa.” – Dave Lennon, President & CEO .
“Our comprehensive review of strategic options to maximize value for shareholders is ongoing, and we will provide further updates when available.” – Dave Lennon .
Q2 call framing: Focus on unlocking mTOR inhibition via nab-sirolimus; commercial backbone with FYARRO and broader mTOR-driven opportunities; cash runway and upcoming catalysts .

Q&A Highlights

PRECISION1 outcomes and FDA path: Management expected to use 2/3 interim as basis for FDA dialogue; now superseded by halt decision after DMC analysis .
FYARRO trajectory: Q2 commentary noted demand rebound across segments and expectation of continued incremental growth into Q3 and Q4 .
EEC/NET programs: Initial data by year-end; for EEC, an ORR exceeding ~20% targeted in Simon’s two-stage design; for NET, aim to improve on historically low ORR with mTOR inhibitors .
Trial design and tumor-agnostic strategy: Emphasized true tumor-agnostic approach without bias to specific indications; highlighted physician enthusiasm in EEC specialists .

Estimates Context

S&P Global consensus (EPS, revenue) for AADI Q3 2024 was unavailable due to missing SPGI/CIQ mapping for the ticker; as a result, direct comparisons to Wall Street estimates cannot be provided at this time. If/when mapping is updated, we can incorporate estimate comparisons and any beat/miss signals for revenue/EPS [GetEstimates error].

Key Takeaways for Investors

Commercial execution is the story near term: FYARRO sales growth (+17% QoQ; +21% YoY) and ~90% reorder rate demonstrate durable demand in malignant PEComa despite pipeline reset .
Balance sheet and runway improved: Runway extended to at least 2H 2026 post restructuring; however, cost discipline must persist given single-product economics .
Pipeline risk reset: With PRECISION1 halted, near-term development value hinges on initial EEC/NET signals later in 2024; scope narrowed (paused enrollment, continue dosing) .
Strategic review is a wild card: Potential corporate actions could be value-moving; timing remains unspecified .
Channel concentration and gross-to-net dynamics are important: Two customers account for the majority of revenue; gross-to-net allowances rose to $1.7M in Q3, requiring ongoing monitoring .
No formal revenue/EPS guidance and limited estimate visibility: With SPGI mapping unavailable, trade around fundamentals and company disclosures (commercial traction, cash runway, strategic updates) [GetEstimates error].
Watch catalysts: 4Q 2024 EEC/NET initial efficacy readouts, any strategic review outcome, and continued commercial momentum updates from FYARRO .

References:
Press release (Q3 results):
Form 8-K with Exhibit 99.1:
Scheduling PR (Q3 timing):
Corporate update PR (PRECISION1 halt):
Q2 2024 earnings call transcript:
Q2 2024 press release and 8-K:
Q1 2024 earnings call transcript and PR:
Form 10-Q (Q3 2024):

Aadi Bioscience, Inc. (AADI)·Q3 2024 Earnings Summary