Executive Summary

Q1 2025 execution remained disciplined ahead of the August 8 PDUFA; LENZ ended the quarter with $194.1M cash, cash equivalents, and marketable securities, and raised projected PDUFA cash to over $185.0M following a $16.3M April ATM block trade .
OpEx ramped in-line with pre-launch plans: SG&A rose to $11.1M (sequential increase vs Q4), R&D was $5.8M, and net loss was $14.6M (EPS $(0.53)); management noted total OpEx up ~11% q/q and net cash burn of ~$15M, reflecting pre-approval build for launch .
Regulatory momentum: mid-cycle review completed with no significant issues; late-cycle review moved forward to late May 2025; FDA continuity cited with no review team changes; CBP rulings confirm LNZ100 is U.S. origin and duty-free, removing tariff uncertainty .
Commercial readiness advanced: >40% of 88 sales territories already accepted offers; full field team targeted by July 1; sampling logistics and e-pharmacy pathways built to drive rapid patient conversion at launch—DTC influencer campaign slated for early 2026 after ECP education in Q4 2025 .
Near-term stock catalysts: late-cycle review outcome, continued hiring milestones and sampling readiness updates, and affirmation of cash runway to post-launch positive operating cash flow; no Street consensus available for revenue/EPS to frame beats/misses this quarter (pre-commercial) .

What Went Well and What Went Wrong

What Went Well

“Upwardly revised anticipated cash balance at PDUFA to over $185.0 million; cash runway anticipated to extend to post-launch positive operating cash flow” (press release) .
FDA interactions remained constructive: “mid-cycle review… noting no significant review issues… late-cycle review meeting… scheduled for late May 2025… no plans to request an Advisory Committee Meeting” (CEO prepared remarks) .
Tariff/country-of-origin certainty: CBP confirmed U.S. origin and duty-free classification—“we are proud to say that LNZ100 is designated Made in the USA” (CEO) .

What Went Wrong

Operating costs continued to ramp ahead of launch: total OpEx rose to $16.9M (≈+11% q/q) driven by commercial build-out; SG&A increased ~19% sequentially to support hiring and pre-launch marketing .
Net loss increased to $(14.6)M (EPS $(0.53)), reflecting manufacturing and commercial readiness spend; compares to $(12.7)M (EPS $(0.46)) in Q4 2024 .
No Street estimates available to benchmark performance, limiting near-term “beat/miss” narrative for trading-focused investors (S&P Global consensus data returned no quarterly revenue/EPS estimates for LENZ in Q1/Q4) .

Financial Results

Metric	Q3 2024	Q4 2024	Q1 2025
Revenue ($USD Millions)	NR	NR	NR
R&D Expenses ($USD Millions)	$6.451	$5.868	$5.818
SG&A Expenses ($USD Millions)	$6.494	$9.357	$11.113
Total Operating Expenses ($USD Millions)	$12.945	$15.225	$16.931
Net Loss ($USD Millions)	$(10.215)	$(12.652)	$(14.619)
EPS (Basic & Diluted) ($)	$(0.38)	$(0.46)	$(0.53)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$217.2	$209.1	$194.1
Weighted-Average Shares (Millions)	27.172	27.493	27.526

Notes:

Management highlighted sequential OpEx up ~11% vs Q4 2024, and SG&A up ~19% q/q (rounded), on commercial hiring and marketing ramp .
The company remains pre-commercial; statements of operations present only operating expenses and other income (no product revenue line reported) .

Estimate Comparison (Q1 2025)

Metric	Consensus Mean	# of Estimates	Actual
Revenue ($USD Millions)	N/A*	N/A*	NR
EPS ($)	N/A*	N/A*	$(0.53)

*S&P Global consensus was queried and returned no quarterly revenue/EPS estimates for LENZ for the relevant periods (pre-commercial company). Values retrieved from S&P Global.

KPIs

KPI	Q3 2024	Q4 2024	Q1 2025
Total Assets ($USD Millions)	$224.0	$215.3	$201.3
Total Liabilities ($USD Millions)	$8.7	$11.2	$9.2
Total Stockholders’ Equity ($USD Millions)	$215.3	$204.1	$192.0
Net Cash Burn ($USD Millions)	—	~$8.1 (Q4)	~$15.0 (Q1)

Discrepancy note: SG&A in Q1 press release was $11.113M ; CFO referenced ~$11.3M on the call (rounding) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash at PDUFA	Aug 8, 2025	>$170M (disclosed at Commercial Day)	>$185.0M	Raised
U.S. Product Availability	Q4 2025	Availability anticipated in Q4 2025	Packaging/shipping post-approval; product in market Q4 2025	Maintained (timeline clarified)
Cash Runway	Post-launch	Funded to post-launch positive operating cash flow	Funded to post-launch positive operating cash flow	Maintained
FDA Review Timing	Late-cycle	—	Late-cycle review moved forward to late May 2025	Advanced schedule
Tariff Classification	Ongoing	—	Duty-free; country of origin U.S. (CBP rulings Nov 7, 2024 and Apr 2, 2025)	Resolved in LENZ’s favor
Sales Force Build	Through Q2 2025	88 territories targeted; leadership hired	>40% offers accepted; full team targeted by July 1, 2025	Progressing

Earnings Call Themes & Trends

Topic	Q3 2024 (Nov 2024)	Q4 2024 (Mar 2025)	Q1 2025 (May 2025)	Trend
Regulatory/FDA	NDA accepted; PDUFA 8/8/2025; no AdCom planned	Mid-cycle review completed; inspections underway	Late-cycle moved forward to late May; review team unchanged; on-track	Continued positive engagement
Commercial Readiness	Commercial leadership in place	RD + all DMs hired; postings for 88 territories	>40% rep offers accepted; target full field by July 1	Accelerating build
Tariffs/Origin	—	—	CBP confirms U.S. origin and duty-free	Risk removed
DTC Marketing	—	Unbranded campaign scaled; creative locked	DTC influencers early 2026; Q4 2025 focus on ECP education	Staged roll-out
Sampling & Access	—	Sample vendor contracted; 5-day packs designed	Rep-delivered sampling; e-pharmacy integration and auto-refill	Execution focus
Manufacturing Readiness	—	Began production of commercial product in Feb 2025	Building inventory to support launch (levels not disclosed)	Scaling inventory
IP/Exclusivity	—	7 granted U.S. patents to 2039; 10 pending to extend to ≥2044	Expect ≥5 years NCE exclusivity; patent estate reinforcement	Strengthening moat

Management Commentary

CEO: “We remain on track for our August 8 PDUFA date… [with] a high level of engagement from the agency… our late-cycle review meeting has been moved forward to later this month” .
CEO: “We are proud to say that LNZ100 is designated Made in the USA” following CBP rulings confirming U.S. origin and duty-free status .
CFO: “We ended Q1 2025 in a position of financial strength… approximately $194.1 million… subsequent to quarter end… net proceeds of $16.3 million… we have upwardly revised our projected cash… to now over $185 million” .
CCO: “As of today, we’ve extended and received accepted offers for over 40% of our field sales team… 97%… have prior eye care or pharma experience” .
CCO: “Our sample vendor has been contracted… five-day sample pack… rep-delivered to eye care professionals… e-pharmacy home delivery” .

Q&A Highlights

Sampling infrastructure: reps will deliver and track samples with monthly replenishment; signed transfers at offices; designed to drive high initial conversion with “wow” effect (95% ≥2 lines improvement at hour one, day one) .
E-pharmacy journey: EMR-integrated, text-to-pay, auto-refill support; LENZ expects to provide guidance on e-pharmacy scripts given limited IQVIA capture .
DTC timing/channels: Q4 2025 dedicated to ECP education; DTC influencers targeted for early 2026 on Facebook, Instagram, YouTube, Pinterest (cash-pay product not gated by PBM coverage) .
Macro sensitivity: management views demand as relatively insulated using medical aesthetics proxies; targeting major metros/higher-income consumers to mitigate recession risks .
Competitive dynamic: emphasis on aceclidine’s pupil selectivity and sub-2mm pupil performance; sampling-heavy strategy intended to win on first-use efficacy versus pilocarpine-based alternatives .

Estimates Context

Street consensus for Q1 2025 revenue and EPS was not available via S&P Global for LENZ (pre-commercial stage); as such, no formal “beat/miss” framing can be made this quarter. S&P Global was queried and returned no quarterly estimates. Values retrieved from S&P Global.
As LENZ transitions to commercial operations (anticipated product availability in Q4 2025), consensus coverage is likely to expand, enabling beat/miss analytics tied to new scripts and refill trajectories .

Key Takeaways for Investors

Regulatory cadence remains favorable: mid-cycle benign; late-cycle moved forward; no AdCom planned—sustains high-confidence path to August 8 PDUFA .
Commercial engine is taking shape: >40% of 88 reps secured; training planned pre-approval; rep-delivered samples and e-pharmacy workflows set to accelerate early adoption and stickiness .
Cash runway strengthened: $194.1M at quarter-end and >$185M expected at PDUFA; funded to post-launch positive operating cash flow—de-risks near-term financing overhang .
Tariff/COO risk removed: duty-free and U.S. origin confirmed—simplifies cost-to-serve and messaging (“Made in USA”) .
Near-term focus: watch late-cycle meeting outcome and hiring completion by July 1; Q4 2025 ECP sampling metrics and early script data (including e-pharmacy) will shape 2026 DTC acceleration .
Modeling caution: Q1 shows pre-launch OpEx ramp (SG&A +~19% q/q) and net loss widened; expect continued spend through launch as manufacturing costs shift to COGS post-approval .
Strategic moat: NCE exclusivity (~5 years) plus expanding patent estate (to ≥2044) positions LENZ for durable economics if clinical/commercial performance meets expectations .

Sources:

Q1 2025 8-K press release (Item 2.02; Exhibit 99.1) .
Q1 2025 earnings call transcripts and –.
Q4 2024 8-K press release and call (for trend) .
Q3 2024 8-K press release (for trend) .

LENZ Therapeutics, Inc. (LENZ)·Q1 2025 Earnings Summary