Name: Aerovate Therapeutics, Inc. Q1 2024 Earnings Call
Start: 2024-05-13T00:00:00.000Z

Executive Summary

Q1 2024 featured continued execution on AV-101 for PAH: Phase 2b topline data guided for June 2024 and Phase 3 enrollment progressing across >120 sites in >20 countries .
Operating expenses increased materially YoY (R&D up 48.9%), widening net loss to $23.19M and EPS to $(0.83) versus $(0.67) a year ago; other income of $1.43M partially offset the loss .
Liquidity remained solid with $99.33M in cash, cash equivalents, and short-term investments at 3/31/2024, augmented by ~$23.6M net raised via the ATM in April; management reiterated cash runway “into 2026” .
Near-term stock catalyst: the June 2024 Phase 2b topline readout (primary endpoint PVR) from IMPAHCT; Phase 3 topline timing to be determined based on Phase 2b results .

What Went Well and What Went Wrong

AV-101 clinical progress: “Topline data expected in June 2024 from the Phase 2b portion of the IMPAHCT trial,” with ongoing Phase 3 enrollment across >120 sites in >20 countries .
Financing flexibility: Raised net proceeds of ~$23.6M in April via ATM; supports runway into 2026 under current operating plan .
Confidence in inhaled imatinib approach: “We remain confident that delivering our proprietary formulation of imatinib directly to the pulmonary vasculature via inhalation has the potential to achieve robust efficacy with a low side effect burden in PAH patients…” — Tim Noyes, CEO (Q4 2023) .

Expense ramp: R&D rose to $20.08M from $13.49M YoY, driven by clinical trial, manufacturing, and headcount costs; G&A increased to $4.54M from $4.15M YoY .
Wider losses: Net loss expanded to $23.19M from $16.52M YoY; EPS to $(0.83) from $(0.67), reflecting higher operating expenses despite $1.43M other income .
No revenue contribution: As a clinical-stage company, results are driven by operating expenses and other income; revenue was not reported in Q1 2024 materials .

Metric	Q1 2023 (YoY base)	Q3 2023	Q4 2023	Q1 2024
Revenues ($USD)	N/A	N/A	N/A	N/A
R&D Expense ($USD Millions)	$13.49	$16.88	$17.81	$20.08
G&A Expense ($USD Millions)	$4.15	$4.48	$4.25	$4.54
Total Operating Expenses ($USD Millions)	$17.64	$21.37	$22.07	$24.62
Loss from Operations ($USD Millions)	$(17.64)	$(21.37)	$(22.07)	$(24.62)
Total Other Income ($USD Millions)	$1.12	$1.81	$1.71	$1.43
Net Loss ($USD Millions)	$(16.52)	$(19.56)	$(20.41)	$(23.19)
Diluted EPS ($USD)	$(0.67)	$(0.71)	$(0.74)	$(0.83)
Weighted-Average Shares (units)	24,777,847	27,640,542	27,695,184	27,795,827
Cash, Cash Equivalents & ST Investments ($USD Millions)	—	$135.20 (as of 9/30/2023)	$122.44 (as of 12/31/2023)	$99.33 (as of 3/31/2024)
Stock-based Comp (Non-cash) ($USD Millions)	$2.40	$3.20	$3.30	$4.20

Notes:

No segment reporting disclosed; margins not applicable without revenue (company reports operating expenses and losses) .

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 2b topline timing	Q2 2024 vs Q1 2024 specificity	“Topline data in the second quarter of 2024” (Q3 2023)	“Topline data expected in June 2024” (Q1 2024)	Refined timing (narrowed to June)
Phase 3 enrollment	Ongoing	“First patient enrolled in November 2023” (Q4 2023); >120 sites noted subsequently	“Enrollment continues; >120 sites in >20 countries participating” (Q1 2024)	Progressing enrollment
Cash runway	Through 2026	“Runway into 2026” reiterated (Q3/Q4 2023)	“Runway into 2026” maintained (Q1 2024)	Maintained
Financing (ATM)	April 2024	Not applicable	Raised ~$23.6M net proceeds under ATM (April 2024)	New financing disclosed
Revenue/Margins/OpEx/OI&E/Tax	2024	Not provided	Not provided	N/A

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
R&D execution and trial timelines	Q3: IMPAHCT Phase 2b/3 on track for Q2 2024 topline; >125 sites activated . Q4: Phase 2b enrollment complete; Phase 3 first patient in Nov 2023; topline 2Q24 .	Specific timing: Phase 2b topline in June 2024; Phase 3 enrollment continues (>120 sites, >20 countries) .	Continued execution; timing refined.
Financing & runway	Q3: Runway into 2026 . Q4: Runway into 2026 maintained .	ATM raised ~$23.6M net in April; runway into 2026 maintained .	Strengthened liquidity; runway unchanged.
IP and leadership	Q3: Patent issuance increased total to five . Q4: Total issued patents six; board enhanced (Dable chair; Santel added) .	No new IP updates in Q1 release; focus on clinical execution .	Stable governance/IP; execution focus.
Clinical footprint	Q3: >125 sites activated in >20 countries .	>120 sites participating in Phase 3 across >20 countries .	Sustained global footprint.
Regulatory/compliance messaging	Standard forward-looking/risk disclosures .	Standard forward-looking/risk disclosures .	Consistent disclosures.

“We remain confident that delivering our proprietary formulation of imatinib directly to the pulmonary vasculature via inhalation has the potential to achieve robust efficacy with a low side effect burden in PAH patients on two or three background therapies.” — Tim Noyes, CEO (Q4 2023 press release) .
Q1 2024 reiterations focused on near-term IMPAHCT milestones (June 2024 Phase 2b topline), active Phase 3 enrollment (>120 sites in >20 countries), and liquidity (ATM proceeds; runway into 2026) .

No Q1 2024 earnings call transcript was available in the document catalog; therefore, Q&A details and tone assessment are unavailable for this period [ListDocuments returned 0 for earnings-call-transcript].

Wall Street consensus (S&P Global) for Q1 2024 was unavailable due to missing CIQ mapping for AVTE at the time of retrieval. Values retrieved from S&P Global.*
With estimates unavailable, we cannot benchmark EPS or operating metrics vs consensus for Q1 2024 at this time.

Near-term catalyst in June 2024: Phase 2b topline (PVR) for AV-101; Phase 3 topline timing depends on Phase 2b results .
Expense ramp reflects trial progression; R&D rose to $20.08M (+48.9% YoY), widening loss to $23.19M and EPS to $(0.83) .
Liquidity remains adequate for clinical milestones: $99.33M at 3/31/2024 plus ~$23.6M net ATM in April; runway maintained into 2026 .
Enrollment momentum and global footprint support Phase 3 execution (>120 sites, >20 countries), but outcome risk is high pending Phase 2b readout .
No revenue reported; equity story remains binary around AV-101 efficacy/safety profile and subsequent regulatory/clinical outcomes .
Positioning: Short-term trading likely keyed to topline data; medium-term thesis hinges on Phase 2b dose selection, safety/tolerability, and Phase 3 6MWD outcome design .

KPI	Q3 2023	Q4 2023	Q1 2024
IMPAHCT Phase 2b topline timing	“Second quarter 2024”	“Second quarter 2024”	“June 2024”
Phase 3 enrollment status	>125 sites activated; enrolling	First patient enrolled Nov 2023	Enrollment continues; >120 sites; >20 countries
ATM financing	Not disclosed	Not disclosed	~$23.6M net raised in April
Cash runway	Into 2026	Into 2026	Into 2026

Balance sheet at 3/31/2024: Cash, cash equivalents and short-term investments $99.33M; total assets $106.82M; total liabilities $15.92M; stockholders’ equity $90.90M .
Non-cash charges: $4.20M in Q1 2024 vs $2.40M in Q1 2023; Q4 2023 $3.30M; Q3 2023 $3.20M .

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