Executive Summary

Q4 2024 was execution-heavy: NDA acceptance with Priority Review for avutometinib + defactinib (PDUFA June 30, 2025) and commercialization prep, while GAAP loss widened on a non‑cash warrant liability mark; non‑GAAP loss improved vs Q3 .
Liquidity: $88.8M cash/investments at 12/31/24; pro forma $151.3M after Oberland refinancing/equity and January ATM—runway through a potential mid‑’25 launch and into Q4 2025 .
Clinical momentum: RAMP 301 (confirmatory LGSOC Phase 3) guided to full enrollment by YE’25; VS‑7375 U.S. IND filed; RAMP 205 (1L pancreatic) expansion dose selection targeted H1’25, but public data update slid to mid‑’25 from prior Q1’25 target .
Key trading catalysts: PDUFA (Jun 30, 2025), mid‑year RAMP 205 update and RP2D, and regulatory/launch readiness; note financing overhang (1–2% revenue participation, high call premia) from Oberland deal .

What Went Well and What Went Wrong

What Went Well
- FDA accepted NDA and granted Priority Review for avutometinib + defactinib in KRAS‑mutant recurrent LGSOC; PDUFA set for June 30, 2025. CEO: “2025 is expected to be a transformational year… potential to launch the first FDA‑approved treatment specifically for KRAS mutant recurrent LGSOC” .
- Non‑GAAP adjusted net loss improved sequentially to $(29.3)M vs $(35.3)M in Q3, reflecting primarily non‑cash drivers in GAAP loss; adjusted EPS $(0.60) vs $(0.88) in Q3 .
- U.S. IND filed for VS‑7375 (KRAS G12D ON/OFF inhibitor) in Q1’25, advancing pipeline optionality beyond LGSOC .
What Went Wrong
- RAMP 205 public data timing pushed from “Q1 2025” to “mid‑year 2025,” extending the wait for confirmatory pancreatic signal; expansion dose still pending until H1’25 .
- GAAP net loss widened to $(64.6)M (EPS $(1.33)) vs $(24.0)M (EPS $(0.60)) in Q3, largely from a $(32.6)M non‑cash warrant liability fair value change .
- Operating expenses remain elevated ahead of potential launch (Q4 Opex $31.6M; FY24 Opex $125.0M), underscoring execution risk if timelines slip .

Financial Results

Income statement snapshot (USD):

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($M)	$10.0	$0.0	$0.0
R&D Expense ($M)	$18.1	$24.8	$20.8
SG&A Expense ($M)	$10.2	$12.3	$10.8
Total Operating Expenses ($M)	$28.3	$37.0	$31.6
Net Loss ($M)	$(8.3)	$(24.0)	$(64.6)
Diluted EPS ($)	$(0.31)	$(0.60)	$(1.33)
Adj. Net Loss ($M, non‑GAAP)	$(16.5)	$(35.3)	$(29.3)
Adj. EPS ($, non‑GAAP)	$(0.61)	$(0.88)	$(0.60)
Change in Warrant Liability ($M)	N/A	+$13.46	$(32.61)

Liquidity snapshot:

Metric	Q2 2024	Q3 2024	Q4 2024
Cash, Cash Equivalents & Investments ($M)	$83.4	$113.2	$88.8
Pro Forma Cash, CE & Investments ($M)	—	—	$151.3 (post Oberland notes/equity and Jan ATM)
Cash Runway Commentary	Through potential approval H1’25	Through potential approval mid‑’25	Through potential launch into Q4’25

Balance sheet highlights (12/31/24):

Warrant Liability: $58.2M; Stockholders’ Equity: $(28.9)M .
Long‑term debt: $40.7M at 12/31/24 (pre Oberland refinancing close) , replaced on 1/13/25 by $75M Oberland notes; net proceeds ≈$32.3M after repaying $42.7M Oxford loan .

Segment/KPIs:

No revenue‑generating segments; key operational KPIs are Opex (R&D/SG&A), cash runway, and clinical milestones .

Vs. Estimates:

Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS was unavailable at query time; comparisons to consensus cannot be shown. Values retrieved from S&P Global were unavailable due to API limits.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
FDA Filing/NDA Status	Q4 2024	FDA filing decision before YE’24; potential approval mid‑’25	NDA accepted; Priority Review; PDUFA 6/30/2025	Achieved acceptance; specificity added
Cash Runway	2025	Through potential approval mid‑’25	Through potential launch into Q4’25	Raised/extended
RAMP 301 (LGSOC Ph3) Enrollment	2025	Complete by YE’25	Complete by YE’25	Maintained
RAMP 205 (1L Pancreatic) Data Timing	2025	Updated data in Q1’25	Present additional data mid‑year ’25; RP2D in H1’25	Delayed public readout
RAMP 203 (NSCLC) Update	2024/25	Updated data by YE’24	Interim update H2’25	Delayed
VS‑7375 (KRAS G12D) IND	Q1 2025	Anticipated U.S. IND by Q1’25	U.S. IND filed Q1’25	Achieved
NCCN inclusion Plan	Post‑approval	Not specified	Plan to submit upon FDA approval	New item

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript was not available in the document set; themes reflect management’s Q4/FY press release plus prior quarter releases.

Topic	Previous Mentions (Q2, Q3)	Current Period (Q4)	Trend
Regulatory—LGSOC NDA	Q2: Rolling NDA initiated ; Q3: Rolling NDA completed, awaiting filing decision	NDA accepted; Priority Review; PDUFA 6/30/2025	Positive progression
Commercial Readiness	Q2–Q3: Launch prep for mid‑’25	Continued commercial preparation	Steady execution
RAMP 205 (Pancreatic)	Q2: Initial interim ASCO data; strong ORR in DL1	Added dose level “0”; expansion; plan RP2D H1’25; data mid‑’25	Slower external data cadence
RAMP 203 (NSCLC)	Q3: Prior‑treated and naïve cohorts updates planned	Triplet cohort with sotorasib + defactinib saw no DLTs; two with ≥20% tumor shrinkage; broader update H2’25	Encouraging early safety; later update timing
VS‑7375 (KRAS G12D)	Q2: China Ph1 initiated	U.S. IND filed; plan to start Ph1/2a mid‑’25	Advancement to U.S.

Management Commentary

“2025 is expected to be a transformational year with our potential to launch the first FDA‑approved treatment specifically for KRAS mutant recurrent low‑grade serous ovarian cancer and become a fully integrated commercial‑stage company.” – Dan Paterson, CEO .
“All dose levels [in RAMP 205] have been expanded to 12 patients each… Based on the initial safety and efficacy data from these cohorts, dose level 1 or 0 is anticipated to be chosen for expansion.” .
On RAMP 203 triplet: “No dose‑limiting toxicities have been observed… preliminary data have shown a generally favorable tolerability profile and encouraging initial anti‑tumor activity.” .

Q&A Highlights

No Q4 2024 earnings call transcript was available in the document set; consequently, Q&A topics and management clarifications cannot be reported based on primary sources.

Estimates Context

S&P Global consensus for Q4 2024 revenue and EPS could not be retrieved at query time due to vendor rate limits; comparisons to consensus are unavailable. Historically, VSTM has minimal quarterly revenue and results are driven by Opex and non‑cash fair value changes, so estimate revisions would likely focus on FY’25 Opex trajectory and timing of potential launch revenues once approved (no consensus figures available).

Key Takeaways for Investors

PDUFA set for June 30, 2025 with Priority Review—primary stock catalyst; launch prep ongoing for mid‑’25 .
Non‑GAAP loss improved sequentially in Q4 despite higher GAAP loss from a large non‑cash warrant liability change; watch for continued control of Opex into H1’25 .
Cash runway extended into Q4’25 post Oberland refinancing and ATM—supports commercial readiness and late‑stage trials, but introduces revenue‑participation (1–2%) and high redemption premia (up to 195%) that are equity‑holder relevant .
Pipeline: RAMP 205 dose selection (H1’25) and mid‑year data; RAMP 203 triplet early safety/activity encouraging but broader efficacy update not until H2’25 .
Confirmatory RAMP 301 enrollment targeted by YE’25—critical for conversion post‑accelerated approval and potential label expansion beyond KRAS‑mutant .
Execution risks: Delays in external data disclosures (RAMP 205/203) vs prior timelines; sustained Opex ahead of approval increases sensitivity to regulatory outcomes .
Near‑term focus: Regulatory interaction updates, launch build‑out metrics, payer/NCCN progress upon approval, and any early commercial guidance once visibility improves .

Additional Relevant Press Releases for Q4 2024

FDA accepted NDA; Priority Review (Dec 30, 2024) .
RAMP 203 triplet preliminary data (Dec 18, 2024) .
NDA completed (Oct 31, 2024) .

Cross‑References and Notes

Preliminary 12/31/24 cash in the Jan 13, 2025 8‑K (Item 2.02) matched final Q4 cash disclosed on Mar 20, 2025 press release ($88.8M) .
Oberland Note Purchase: $75M initial; optional $25M on approval and up to $50M based on sales; 1–2% revenue participation; significant redemption multipliers—material financing terms for valuation frameworks .

Verastem, Inc. (VSTM)·Q4 2024 Earnings Summary