ACHV Stock — Achieve Life Sciences Inc.: Cash, EV, Pipeline

What they do

Our primary focus is to address this global epidemic. While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain highly addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease. In 2024, 1.6 million high school and middle school students reported using e-cigarettes.

Source: 10-K FY2025 via SEC EDGAR

Share price

$6.72

Market cap

$691.5M

Cash

$187.3M

Enterprise value

$504.2M

Balance sheet

Cash	$187.3M
Debt	$0.0M
Net cash	$187.3M
Enterprise value	$504.2M
Basic shares	102.9M shares
Fully diluted shares	200.6M shares
Fully diluted market cap	$1,348.3M
Cash per share	$1.82
Quarterly burn	$10.8M
Cash runway	17.4 quarters

Cash figures as of 2026-06-30. Database snapshot: 2026-11-07.

Share structure

Common

102.9M

Pre-funded warrants

0.2M

Options

9.3M

RSUs

14.5M

Warrants

69.9M

Converts

2.5M

Conv preferred

0.0M

ESPP reserve

1.3M

FDSO

200.6M

Cap table as of 2026-06-30.

Price history

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Next catalyst

cytisinicline · Est. Nov 15, 2026 · quarter midpoint · guided Now

Upcoming catalysts

Expected	Drug	Phase	Indication	Mgmt guide
GUIDEDEst. Nov 15, 2026 Now quarter midpoint	cytisinicline NDA resubmission for smoking cessation	Not disclosed	smoking cessation	Q4 2026
Dec 27, 2026 - Feb 7, 2027 in 7 wks	Cytisinicline	Phase 3	Vaping Cessation	H1 2027 Est. Jan 1, 2027 · PCD + 6 wks (Jan 1-Jan 10)

Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.

Full readout calendar →

Pipeline assets

Cytisinicline

Phase 3 · Active

Aliases cytisine, Tabex

Target nicotinic acetylcholine receptor

Partnerships Sopharma AD: license + supply agreements (mid-single digit royalties on Tabex-branded net sales in territory; $2.0M deferred consideration contingent on FDA/EMA approval via 2015 Extab share purchase); Adare Pharma Solutions: U.S.-based finished drug product manufacturer named for NDA resubmission and commercial supply (~$3.2M development agreements; Adare CEO Thomas Sellig is an Achieve board member)

Indications

Smoking cessation (Phase 3)
Nicotine e-cigarette (vaping) cessation (Phase 2)

Catalysts

— Q4 2026
— first half of 2027

Status note NDA for smoking cessation submitted Jun 2025, accepted Sep 2025 with PDUFA Jun 20, 2026. FDA issued Complete Response Letter Jun 2026 citing manufacturing-related observations at a third-party facility (OAI classification + warning letter) and incomplete final labeling; no efficacy or safety deficiencies identified. NDA resubmission planned Q4 2026 naming Adare; potential approval H1 2027. Filing states cytisinicline is the company's sole product candidate. Commissioner's National Priority Voucher (CNPV) awarded Oct 2025 for nicotine e-cigarette cessation. Sopharma filed an arbitration demand Jul 2026 alleging breach of the supply agreement over use of third-party manufacturers; company disputes it.

Per-asset detail extracted from the 10-Q filed 2026-08-11. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.

Pipeline

Lead drug	Cytisinicline
Lead indication	Vaping Cessation
Lead phase	Phase 3
Active trials	1

Active clinical trials

Trial	Phase	Status	Role	Sponsor	BP	Condition(s)	Mgmt guide
NCT07392125	Phase 3	Not yet recruiting	Sponsor	Achieve Life Sciences	—	Vaping Cessation	H1 2027 Est. Jan 1, 2027 · PCD + 6 wks (Jan 1-Jan 10)

Sponsor-matched active trials from ClinicalTrials.gov (1 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.

View all 1 active trials for Achieve Life Sciences on ClinicalTrials.gov

Specialist fund holders

Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.

Fund	Shares	Q/Q change	% of portfolio	Filing
Frazier Life Sciences	7,614,836	+7,614,836	1.08%	2026-08-14
Logos Global Management	5,425,000	+5,425,000	1.53%	2026-08-14
Vivo Capital	2,751,032	+2,751,032	1.64%	2026-08-14
ADAR1 Capital Management	53,800	+6,000	0.02%	2026-08-14

Specialist-fund positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.

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ACHV — Achieve Life Sciences Inc. ☆