Achieve Life Sciences Q3 net loss narrows to $12.1M
Achieve Life Sciences, Inc. (ACHV) reported third-quarter 2026 operating expenses of $20.5 million and a net loss of $12.1 million, compared with $14.7 million and $14.4 million, respectively, a year earlier.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Achieve Life Sciences, Inc. (ACHV) reported third-quarter 2026 operating expenses of $20.5 million and a net loss of $12.1 million, compared with $14.7 million and $14.4 million, respectively, a year earlier. For the first nine months, operating expenses were $49.4 million and net loss was $97.0 million, versus $40.1 million and $40.0 million in 2025. Third-quarter net loss included a $6.9 million non-cash gain related to a change in the fair value of warrant liabilities. Cash, cash equivalents and marketable securities totaled $201.5 million as of September 30, 2026, compared with $187.3 million as of June 30, primarily due to proceeds from warrant exercises.
In the 479-person, long-term open-label ORCA-OL trial, four-week continuous abstinence rose from 25.5% at Weeks 9–12 to 31.2% at Weeks 49–52; the independent Data Safety Monitoring Committee identified no new safety signals. Achieve Life Sciences completed three commercial-scale stability batches for U.S.-based finished drug product manufacturing. The NDA resubmission remains on track for the fourth quarter of 2026; potential FDA approval is anticipated by the end of the second quarter of 2027, with U.S. commercial launch to follow if approved.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointQuarterly net loss was $12.1 million, compared with $14.4 million a year earlier.
Negative
- Moderate pointNine-month net loss was $97.0 million, compared with $40.0 million in 2025.
Filing Explained
The release identifies key approval uncertainties: whether stability data will support the planned NDA resubmission, whether the FDA will require more data to address its complete response letter, and whether pre-approval inspections and manufacturer supply will be successful.
8-K Event Classification
Key Figures
Key Terms
four-week continuous abstinence medical
New Drug Application (NDA) regulatory
commercial-scale stability batches technical
warrant liabilities financial
Commissioner’s National Priority Voucher regulatory
Earnings Snapshot
NDA resubmission remains on track for the fourth quarter of 2026; potential FDA approval is anticipated by the end of the second quarter of 2027, with U.S. commercial launch to follow if approved.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were ACHV's third-quarter 2026 financial results?
How much cash did ACHV have at September 30, 2026?
What did the ORCA-OL trial report at 52 weeks?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
|
|
|||
(State or Other Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|||
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: (
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol |
Name of exchange on which registered |
The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 10, 2026, Achieve Life Sciences, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
|
|
|
99.1
104 |
|
Press release of Achieve Life Sciences, Inc. dated November 10, 2026 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
________________________
The information in Item 2.02 of this Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
________________________
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
ACHIEVE LIFE SCIENCES, INC. |
Date: November 10, 2026 |
/s/ BENJAMIN HALLADAY |
|
Benjamin Halladay Chief Financial Officer (Principal Financial Officer) |
Exhibit 99.1
AchieveRx Reports Third Quarter 2026 Financial Results and Provides Business Updates
Launched new corporate brand as AchieveRx, The Quit Company (Nasdaq: QUIT)
Presented 52-week ORCA-OL data at the CHEST 2026 Annual Meeting showing that nearly one in three adults still smoking or vaping after a supervised quit attempt in a prior trial (a median of five quit attempts among those who smoked) had quit by the end of treatment, with quit rates rising over the course of the year
Expanded leadership team with two senior appointments, strengthening the launch team
Completed three commercial-scale stability batches for U.S.-based finished drug product manufacturing; NDA resubmission remains on track for the fourth quarter of 2026
Cash, cash equivalents, and marketable securities of $201.5 million as of September 30, 2026
SEATTLE and VANCOUVER, British Columbia, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc., doing business as AchieveRx (AchieveRx or the Company) (Nasdaq: QUIT), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the third quarter of 2026 and provided business updates.
“Becoming AchieveRx, The Quit Company, reflects our shift from a clinical-stage company to one preparing to launch what could be the first new FDA-approved prescription medicine in 20 years to help people who smoke quit,” said Andrew D. Goldberg, MD, Chief Executive Officer, AchieveRx. “Our 52-week ORCA-OL results add to the growing body of evidence supporting cytisinicline as a potential treatment option for people looking to quit smoking. With an experienced launch team and our NDA resubmission on track for later this year, we are well positioned to bring cytisinicline to people who want to quit, if it is approved.”
Key Highlights
Clinical and Regulatory
Corporate
Financial Results
As of September 30, 2026, the Company’s cash, cash equivalents, and marketable securities were $201.5 million, compared to $187.3 million as of June 30, 2026. The increase in cash, cash equivalents, and marketable securities was primarily due to proceeds received from the exercise of previously issued warrants. Total operating expenses for the three and nine months ended September 30, 2026, were $20.5 million and $49.4 million, respectively. Total net loss for the three and nine months ended September 30, 2026, were $12.1 million and $97.0 million, respectively. Net loss for the quarter includes a non-cash gain of $6.9 million related to the change in fair value of the warrant liabilities issued in connection with the Company’s private placement in the second quarter of 2026.
“The opportunity ahead of us is large, and so is our duty to fund it well,” said Ben Halladay, Chief Financial Officer, AchieveRx. “We’re entering this next phase with a strong balance sheet, and my priority is disciplined capital allocation that supports both our NDA resubmission and readiness for a potential U.S. launch in 2027.”
About AchieveRx
AchieveRx is a late-stage pharmaceutical company with a singular focus on nicotine dependence. AchieveRx’s mission is to develop medicine for people who want to quit smoking or vaping. That medicine is cytisinicline, an investigational compound. Three ideas guide the Company: simplicity, science, and second chances, for good™. To learn more, visit www.AchieveRx.com.
About Cytisinicline
Cytisinicline is an investigational compound that binds to nicotinic receptors. It is being developed as an oral tablet to aid smoking and e-cigarette cessation in adults. The FDA has granted the vaping cessation program Breakthrough Therapy designation and a Commissioner’s National Priority Voucher. The NDA for cytisinicline for smoking cessation in adults is supported by two successfully
completed Phase 3 studies (ORCA-2 and ORCA-3) and an open-label long-term safety study (ORCA-OL). The Company has also completed a Phase 2 study of cytisinicline in e-cigarette cessation (ORCA-V1) and held an end-of-Phase 2 meeting with the FDA.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements regarding the timing and outcome of the Company’s planned NDA resubmission for cytisinicline and potential FDA approval, the Company’s transition of finished drug product manufacturing to Adare, the timing of any potential U.S. commercial launch, the potential benefits of and market for cytisinicline, the Company’s commercialization plans and readiness, the Company’s cash position and use of capital, and the anticipated benefits of new executive leadership. The Company may not achieve its plans, projections, or other expectations and may not be able to successfully complete its NDA resubmission or obtain regulatory approval for cytisinicline on the anticipated timeline or at all. Factors that could cause actual results to differ materially include, among others: whether the Company generates stability data sufficient to support the NDA resubmission on the anticipated timeline; whether the resubmission adequately addresses the matters cited in the FDA’s complete response letter or the FDA requires additional data prior to approval; the outcome of any pre-approval inspection of Adare or other manufacturers and their ability to supply cytisinicline; the outcome of the Company’s dispute with Sopharma AD; the Company’s ability to raise additional capital as needed; and the Company’s ability to successfully commercialize cytisinicline, if approved. These statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those detailed in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
Contacts:
Investors
Nicole Jones
ir@achieverx.com
425-686-1510
Media
Kaitlyn Tuson
media@achieverx.com
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Consolidated Statements of Loss |
|
||||||||||||||||
(In thousands, except per share and share data) |
|
||||||||||||||||
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
||||||||||
|
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
6,214 |
|
|
|
5,320 |
|
|
|
13,314 |
|
|
|
19,124 |
|
General and administrative |
|
|
|
14,321 |
|
|
|
9,372 |
|
|
|
36,076 |
|
|
|
21,025 |
|
Total operating expenses |
|
|
|
20,535 |
|
|
|
14,692 |
|
|
|
49,390 |
|
|
|
40,149 |
|
Loss from operations |
|
|
|
(20,535 |
) |
|
|
(14,692 |
) |
|
|
(49,390 |
) |
|
|
(40,149 |
) |
Other income |
|
|
|
8,425 |
|
|
|
251 |
|
|
|
(47,657 |
) |
|
|
163 |
|
Net loss |
|
|
$ |
(12,110 |
) |
|
$ |
(14,441 |
) |
|
$ |
(97,047 |
) |
|
$ |
(39,986 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share |
|
|
$ |
(0.11 |
) |
|
$ |
(0.28 |
) |
|
$ |
(1.15 |
) |
|
$ |
(0.99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of basic and diluted common shares |
|
|
|
105,477,761 |
|
|
|
51,017,662 |
|
|
|
84,314,259 |
|
|
|
40,189,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Consolidated Balance Sheets |
|
||||||||||||||||
(In thousands) |
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
||||
|
|
|
|
|
|
|
|
|
2026 |
|
|
2025 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash, cash equivalents and marketable securities |
|
|
|
|
|
|
|
|
$ |
201,518 |
|
|
$ |
36,404 |
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
|
|
1,894 |
|
|
|
3,485 |
|
||
Other assets and restricted cash |
|
|
|
|
|
|
|
|
|
253 |
|
|
|
52 |
|
||
Right-of-use assets |
|
|
|
|
|
|
|
|
|
974 |
|
|
|
64 |
|
||
Other intangible assets |
|
|
|
|
|
|
|
|
|
166 |
|
|
|
— |
|
||
License agreement |
|
|
|
|
|
|
|
|
|
584 |
|
|
|
751 |
|
||
Goodwill |
|
|
|
|
|
|
|
|
|
1,034 |
|
|
|
1,034 |
|
||
Total assets |
|
|
|
|
|
|
|
|
$ |
206,423 |
|
|
$ |
41,790 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
|
|
|
|
|
|
|
$ |
10,240 |
|
|
$ |
3,760 |
|
||
Current portion of long-term obligations |
|
|
|
|
|
|
|
|
|
286 |
|
|
|
61 |
|
||
Current portion of convertible debt |
|
|
|
|
|
|
|
|
|
7,454 |
|
|
|
3,704 |
|
||
Contingent consideration |
|
|
|
|
|
|
|
|
|
1,407 |
|
|
|
1,557 |
|
||
Non-current portion of convertible debt |
|
|
|
|
|
|
|
|
|
5,595 |
|
|
|
11,185 |
|
||
Other long-term obligations |
|
|
|
|
|
|
|
|
|
712 |
|
|
|
5 |
|
||
Stockholders' equity |
|
|
|
|
|
|
|
|
|
180,729 |
|
|
|
21,518 |
|
||
Total liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
$ |
206,423 |
|
|
$ |
41,790 |
|
||