Executive Summary

Nuvalent reported Q4 2024 net loss of $74.8M and EPS of $(1.05), an improvement vs Q3’s $84.3M loss and $(1.28) EPS, driven by higher interest income and a smaller revenue share liability fair value charge .
Operating momentum continued: Expanded Access Programs (EAPs) launched for zidesamtinib (ROS1) and neladalkib (ALK); pivotal data for pre‑treated ROS1 and ALK NSCLC expected in 2025; first NDA submission targeted mid‑2025 for zidesamtinib and potential first approval in 2026 .
Cash, cash equivalents and marketable securities were $1.12B at year‑end, supporting runway into 2028; Q4 OpEx increased sequentially with R&D of $69.4M and G&A of $16.9M as programs advanced .
Stock reaction catalysts over the near term include the mid‑2025 NDA submission, pivotal readouts (ROS1 H1 2025; ALK YE 2025), and initiation of the ALKAZAR Phase 3 front‑line ALK trial in H1 2025 .

What Went Well and What Went Wrong

What Went Well

Implemented global EAPs for both zidesamtinib and neladalkib, expanding patient access ahead of pivotal data and potential filings .
Robust clinical execution with cumulative enrollments: ARROS‑1 (ROS1) 430 patients and ALKOVE‑1 (ALK) 596 patients as of Dec 31, 2024, supporting registrational intent .
Management reiterated confidence transitioning to a commercial-stage company: “we believe we are well‑positioned to deliver on our near‑, mid‑ and long‑term goals” — James Porter, Ph.D., CEO .

What Went Wrong

Operating expenses rose materially on program advancement: Q4 R&D $69.4M (+14.7% QoQ) and G&A $16.9M (+7.0% QoQ), pressuring OpEx and equity usage .
Continued net losses with non‑cash volatility from the related party revenue share liability (Q4: $(1.34)M; Q3: $(16.6)M), adding uncertainty to periodic P&L reported results .
No numeric revenue or margin guidance; timelines carry execution risk (enrollment, regulatory interactions) per forward‑looking statements and risk disclosures .

Financial Results

P&L and EPS (USD, except per-share; thousands denote $MM formatting in table)

Metric	Q2 2024	Q3 2024	Q4 2024
Research & Development ($USD Millions)	$49.166	$60.551	$69.423
General & Administrative ($USD Millions)	$15.984	$15.780	$16.876
Total Operating Expenses ($USD Millions)	$65.150	$76.331	$86.299
Loss from Operations ($USD Millions)	$(65.150)	$(76.331)	$(86.299)
Change in FV of Revenue Share Liability ($USD Millions)	—	$(16.600)	$(1.340)
Interest & Other, net ($USD Millions)	$8.154	$8.626	$13.047
Total Other, net ($USD Millions)	$8.154	$(7.974)	$11.707
Net Loss ($USD Millions)	$(57.166)	$(84.345)	$(74.763)
Net Loss per Share (Basic/Diluted) ($USD)	$(0.88)	$(1.28)	$(1.05)

Notes: Company statements of operations do not present a revenue line; reported results reflect operating expenses and other income/expense only .

Balance Sheet Snapshot (USD Millions)

Metric	Q2 2024	Q3 2024	Q4 2024
Cash, Cash Equivalents & Marketable Securities	$657.994	$1,168.309	$1,118.302
Working Capital	$628.066	$1,128.543	$1,078.428
Total Assets	$675.230	$1,188.858	$1,141.752
Total Liabilities	$38.192	$67.732	$71.960
Total Stockholders’ Equity	$637.038	$1,121.126	$1,069.792

KPIs (Clinical and Regulatory)

KPI	Q2 2024	Q3 2024	Q4 2024
FDA Breakthrough Therapy Designation	BTD granted for zidesamtinib and NVL‑655	—	—
ARROS‑1 Enrollment (ROS1)	Phase 2 ongoing; update planned at ESMO	227 Phase 2 pts through 9/1/24	430 total Phase 1/2 pts as of 12/31/24
ALKOVE‑1 Enrollment (ALK)	Phase 2 initiated; update planned at ESMO	229 Phase 2 pts through 9/1/24	596 total Phase 1/2 pts as of 12/31/24
Expanded Access Programs	—	—	EAPs launched for ROS1 and ALK programs
Front‑Line ALK Strategy	To be outlined later in 2024	ALKAZAR global P3 announced; initiation H1’25	ALKAZAR initiation confirmed H1’25
NDA Timeline (ROS1)	—	First pivotal data in 2025; first approved product 2026 (plan)	First NDA mid‑2025; potential first approval in 2026

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi‑year	Operating runway into 2028 (Q3)	Operating runway into 2028 (Q4)	Maintained
ALKAZAR Phase 3 Initiation	H1 2025	Announced, initiation planned H1 2025 (Q3)	Initiation in H1 2025 reiterated (Q4)	Maintained
ROS1 Pivotal Readout (TKI pre‑treated)	H1 2025	Pivotal data expected in 2025 (Q3)	Pivotal data expected in H1 2025 (Q4)	Narrowed timing window
ROS1 NDA Submission (zidesamtinib)	Mid‑2025	First approved product targeted 2026 (plan)	First NDA planned mid‑2025; potential first approval 2026	Introduced specific NDA timing
ALK Pivotal Readout (TKI pre‑treated)	YE 2025	Pivotal data expected in 2025 (Q3)	Pivotal data expected by year‑end 2025 (Q4)	Clarified timeline

No numeric revenue, margin, OpEx, tax, or OI&E guidance was provided in Q4; management reiterated pipeline timelines and cash runway .

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available in our document set; themes below reflect press releases and 8‑K disclosures.

Topic	Previous Mentions (Q2 2024)	Previous Mentions (Q3 2024)	Current Period (Q4 2024)	Trend
Clinical Enrollment Momentum	Phase 2 updates planned at ESMO for ARROS‑1 and ALKOVE‑1	227 (ROS1) and 229 (ALK) Phase 2 enrollments through 9/1/24	430 (ROS1) and 596 (ALK) total pts as of 12/31/24	Accelerating
Regulatory Designations	BTD granted for zidesamtinib and NVL‑655	—	EAPs launched for both programs	Positive access expansion
Front‑Line ALK Strategy	To be outlined later in 2024	ALKAZAR trial announced; H1 2025 start	ALKAZAR H1 2025 initiation reiterated	Progressing to P3
ROS1 NDA/Approval Timeline	—	Plan: pivotal data 2025; first approval 2026	First NDA mid‑2025; potential approval 2026	Firming timeline
Cash Runway	Into 2027	Into 2028 (post offering)	Into 2028	Stable/extended
Publications/External Validation	—	NVL‑655 publication in Cancer Discovery	—	Neutral

Management Commentary

“We believe we are on track to report pivotal data for TKI pre‑treated patients from both trials this year and to submit our first NDA by mid‑year 2025.” — Darlene Noci, A.L.M., Chief Development Officer .
“As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company… we believe we are well‑positioned to deliver on our near‑, mid‑ and long‑term goals.” — James Porter, Ph.D., CEO .
“We believe our recent upsized public offering reflects the shared excitement… and the potential for multiple value‑creating catalysts ahead.” — Alexandra Balcom, CFO (Q3 context) .

Q&A Highlights

No Q4 2024 earnings call transcript identified in our document set; therefore Q&A themes and clarifications are not available for this period.

Estimates Context

Wall Street consensus for Q4 2024 EPS and revenue (S&P Global) was unavailable due to data access limits at the time of retrieval. As a result, we cannot provide beat/miss analysis versus consensus for this quarter. If/when accessible, comparisons should anchor to S&P Global consensus.

Key Takeaways for Investors

Near‑term regulatory catalysts: First NDA submission for zidesamtinib targeted mid‑2025 and potential first approval in 2026; H1 2025 initiation of ALKAZAR Phase 3 in front‑line ALK NSCLC .
Clinical execution remains strong with accelerating enrollment and expanded access programs, supporting pivotal data readouts in 2025 (ROS1 H1; ALK YE) .
Cash runway into 2028 provides strategic flexibility to advance multiple programs through pivotal phases and potential commercialization buildout .
P&L volatility from fair value revenue share liability and increasing OpEx should be monitored; net loss improved QoQ on higher interest income despite higher R&D/G&A .
Absence of numeric guidance (revenue/margins) focuses the narrative on milestone delivery; stock likely to trade on clinical/regulatory events timing rather than near‑term fundamentals .
Watch for FDA interactions (accelerated pathways, line‑agnostic indications) and data on brain metastases/resistance mutation coverage to support differentiated profiles vs incumbents .
Consider position sizing around expected H1 2025 ROS1 pivotal disclosure and mid‑2025 NDA filing windows as potential binary catalysts .

Nuvalent, Inc. (NUVL)·Q4 2024 Earnings Summary