Executive Summary

Achieve submitted the NDA for cytisinicline (smoking cessation) in June, established a broad commercialization partnership with Omnicom, and raised $49.3M gross; management frames these as “three transformative milestones” that set up 2026 approval/launch readiness .
Q2 financials reflect the pre-commercial transition: OpEx rose year over year with R&D $6.71M and G&A $5.86M, driving net loss of $12.72M ($0.37) vs $8.46M ($0.25) in Q2 2024; cash and securities increased to $55.4M after the financing, extending runway “into 2026”/“second half of 2026” .
Regulatory timeline: Day-74 NDA acceptance letter expected mid-September; 120‑day safety update in October; standard review most likely (priority review requested but viewed as unlikely) .
Commercial catalysts: premium pricing positioning vs generic varenicline (Chantix) discussed with payers; pre‑approval information exchange to begin in Q4; AI‑enabled, targeted launch strategy via Omnicom/Credera to drive efficient awareness, access, availability .

What Went Well and What Went Wrong

What Went Well

NDA submission achieved; management sees “a defining moment” with a clear regulatory, commercial, and financial path; PDUFA timing to be confirmed upon acceptance .
Long-term safety exposure milestones met in ORCA‑OL (≥300 participants with ≥6 months, ≥100 with one year; ACHV indicated 290 had completed one year as of July) supporting tolerability and the 120‑day update; DSMC found no new safety signals .
Omnicom partnership consolidates seven specialized agencies into an AI‑enabled commercial platform to scale efficiently and reduce costs; teams fully activated across brand, access, media, tech .

Selected quote: “We achieved three transformative milestones… [NDA submission]… a strategic commercial partnership with… Omnicom… and a $49,000,000 capital raise that positions us to reach critical value inflection points in 2026, including potential product approval.”

What Went Wrong

Elevated OpEx vs prior year as ACHV invests in regulatory and pre-commercial build: Q2 OpEx $12.56M vs $8.43M in Q2 2024; net loss widened to $12.72M vs $8.46M; EPS $(0.37) vs $(0.25) .
Priority review deemed unlikely despite request, implying a standard review timeline and later potential approval/launch (late 2026) .
Commercial spending set to ramp incrementally pre‑approval; management stresses discipline, but investors should expect higher spend ahead of launch .

Financial Results

Note: Achieve is pre‑commercial; no product revenue was reported in the earnings materials. Financial focus remains on OpEx, cash runway, and net loss .

P&L highlights (USD Millions, except per share)

Metric	Q2 2024	Q1 2025	Q2 2025
Research & Development	$5.113	$7.097	$6.707
General & Administrative	$3.318	$5.797	$5.856
Total Operating Expenses	$8.431	$12.894	$12.563
Other Income (Expense)	$(0.030)	$0.067	$(0.155)
Net Loss	$(8.461)	$(12.827)	$(12.718)
Basic & Diluted EPS	$(0.25)	$(0.37)	$(0.37)
Weighted Avg Shares (M)	34.319	34.685	34.685

Balance sheet and liquidity (USD Millions)

Metric	12/31/2024	3/31/2025	6/30/2025
Cash, Cash Equivalents & Marketable Securities	$34.360	$23.245	$55.397
Total Assets	$38.633	$27.358	$58.935
Convertible Debt - Current	—	$1.194	$1.208
Convertible Debt - Non-current	$9.837	$8.657	$8.657
Stockholders’ Equity	$20.899	$10.279	$41.668
Liquidity Commentary	“Runway into Q3’25” (legacy), extended to “into 2026”/“2H’26” post raise	—	—

KPIs and program milestones

KPI	Prior Periods (Q4’24, Q1’25)	Current (Q2’25)
ORCA‑OL ≥6 months exposure	300+ participants achieved (gate for NDA)	Maintained; included in NDA
ORCA‑OL ≥12 months exposure	Reached 100 participants in Q1’25 (fed into 120‑day safety update)	“As of July, 290 participants” with one‑year exposure; final subject projected early Oct
DSMC Safety Reviews	Two positive DSMC reviews; no safety concerns	Continued monitoring; no new safety signals reported
Cash Runway	YE’24 cash $34.4M; runway into Q3’25	Cash/securities $55.4M; runway “into 2026”/“2H’26” post $49.3M gross raise

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
NDA Submission (smoking cessation)	2Q25	Submit by end of Q2’25	Submitted in June 2025	Achieved
NDA Acceptance (Day‑74 letter)	3Q25	Not previously specified	Expected mid‑September 2025	New timing
120‑Day Safety Update	4Q25	Plan to submit during review	Submit in October 2025	Timed
Review Type	2025‑2026	Not specified	Priority review requested; most likely standard review	Clarified (lower likelihood of priority)
U.S. Launch Timing	2026	Planned 3Q 2026	“Late 2026” (post‑approval)	Slightly later/less specific
Payer Pre‑Approval Info Exchange	4Q25–1Q26	Not specified	Begin PAI in Q4’25; outsourced AMs in Q1’26	New
Pricing Positioning	Pre‑launch	In evaluation	Branded product at premium price vs generic varenicline	Formalized stance
Cash Runway	2025‑2026	Into Q3’25	Into 2026 / 2H 2026	Extended via raise

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4’24 and Q1’25)	Current Period (Q2’25)	Trend
Regulatory path	On track to file NDA end Q2’25; ORCA‑OL safety exposure gating achieved/near	NDA submitted; Day‑74 letter mid‑Sep; 120‑day safety update in Oct	Advancing per plan
Safety/tolerability	DSMC reviews: no concerns; high adherence	No new safety signals; 290 with one‑year exposure as of July	Reinforced
Commercial strategy (AI/data)	Digital‑first, targeted approach; 3PL selection; label/packaging groundwork	Omnicom consolidated 7 agencies; AI‑enabled platform; PAI in Q4; outsourced AMs in Q1	Accelerating
Pricing & access	Payer research ongoing; value communication; specialty‑light channel contemplated	Premium branded pricing stance; payer discussions aligned	Clearer positioning
Partnerships	Considering COPD/comorbidity studies; open to strategic options	Focused on NDA/Omnicom; partnering to be re‑engaged post‑submission	De‑prioritized near term
Vaping indication	EoP2 alignment; Breakthrough Therapy; plan ORCA‑V2 in 1H’26 (funding‑dependent)	No change; remains post‑smoking NDA priority	Maintained

Management Commentary

“We achieved three transformative milestones… [NDA]… Omnicom… and a $49,000,000 capital raise… to reach critical value inflection points in 2026, including potential product approval.” — Richard Stewart, CEO
“We officially submitted our NDA… supported by data from over 2,000 clinical trial participants… and long‑term exposure safety results… Meeting both critical thresholds… was essential.” — Cindy Jacobs, President & CMO
“We are building… a proprietary AI‑enabled commercial platform… to enable precision, agility, and measurable outcomes… reducing costs… and remaining highly adaptive.” — Jaime Xinos, CCO
“As of June 30, 2025, we had cash, cash equivalents and marketable securities totaling $55.4 million… expected to support operations into 2026.” — Mark Oki, CFO

Q&A Highlights

Pricing strategy: ACHV expects “a branded product at a premium price” vs generic varenicline; early payer feedback “not in disagreement” .
Spend cadence: pre‑commercial expenses will “increase over the coming quarters,” with discipline, then step up on approval .
Review timeline: Priority review requested (including via the commissioner’s national priority voucher program), but management views standard review as most likely .
Safety update scope: 120‑day update will submit all subjects available at June database cut (exceeding the 100 threshold) .
Field market access: PAI begins Q4’25; outsourced account managers targeted for Q1’26 .

Estimates Context

S&P Global consensus for quarterly EPS and revenue was not available for ACHV for Q2 2025 (pre‑commercial stage). We attempted to retrieve consensus; no data were returned for the relevant periods. Values retrieved from S&P Global.*

Key Takeaways for Investors

Regulatory momentum is intact: NDA submitted; Day‑74 acceptance (mid‑Sep) and 120‑day safety update (Oct) are near‑term catalysts that could shape the approval timeline and investor sentiment .
Safety/tolerability profile continues to look supportive, with extensive long‑term exposure data and no new safety signals identified by DSMC—an important de‑risking factor into approval .
Commercial plan emphasizes efficiency and precision via Omnicom/AI; early payer work and PAI in Q4’25 suggest deliberate access groundwork ahead of a 2026 launch .
Financial runway now reaches into 2026/2H’26 after $49.3M gross raise, supporting regulatory review and pre‑launch build while management reiterates disciplined spend .
Expect elevated OpEx and ongoing net losses pre‑launch; watch for updates on pricing, access, and manufacturing readiness as spending ramps .
Optionality: COPD/comorbidity partnerships and global commercialization remain potential levers post‑NDA milestones; priority review is a positive swing factor but currently unlikely per management .
Trading setup: Upcoming acceptance letter and visibility on review type/timing, plus any priority review decision, are the most proximate stock catalysts; later 120‑day safety update is another checkpoint .

Appendix: Additional Quantitative References

Q2 financial statement excerpts (press release/8‑K)

Metric	Q2 2025	Source
Net loss	$(12.718)M
EPS (basic/diluted)	$(0.37)
R&D	$6.707M
G&A	$5.856M
OpEx total	$12.563M
Cash & securities (6/30/25)	$55.397M
Runway commentary	Into 2026 / 2H’26

Prior comparisons

Metric	Q1 2025	Q2 2024
Net loss	$(12.827)M	$(8.461)M
EPS	$(0.37)	$(0.25)
R&D	$7.097M	$5.113M
G&A	$5.797M	$3.318M
Cash & securities	$23.245M (3/31/25)	—

Sources: Q2’25 call and press release ; Q2’25 press release/8‑K (financials) ; Q1’25 8‑K/call ; Q4’24 call/press release ; NDA submission PR .

ACHIEVE LIFE SCIENCES, INC. (ACHV)·Q2 2025 Earnings Summary