By John Vandermosten, CFA
NASDAQ:ACHV
READ THE FULL ACHV RESEARCH REPORT
Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported first quarter results following the recent appointment of Dr. Andrew Goldberg as CEO and a material capital raise. In its report, management reiterated expectations that it will receive a Complete Response Letter (CRL) and affirmed its intent to resubmit a New Drug Application (NDA) in 4Q:26. If Achieve is able to hold this timeline, it should support a 1H:27 launch of cytisinicline in smoking cessation. Along with first quarter results, the company announced several changes to the board including the appointment of a new Chairman and new leadership in the commercialization team. The new professionals bring experience gained at Verona Pharma. They launched Ohtuvayre in 2024 which is estimated to be an $800 million drug this year.
As previously mentioned, Adare Pharma Solutions will be Achieve’s primary manufacturer for cytisinicline. It has completed the technology transfer, successfully manufactured its first cytisinicline engineering batch and fully qualified all testing procedures at the facility. Achieve announced the shift to Adare in March citing the domestic location of the manufacturer, the avoidance of tariffs and the Official Action Indicated (OAI) classification at its European manufacturer as reasons for the change.
Financial and Operational Results
Achieve’s 1Q:26 financial and operational results were detailed in a press release, Form 10-Q filing and webcast, which provided analysts the opportunity to ask questions. No revenues were reported in 1Q:26. Operating expense was $10.5 million producing a net loss of $10.2 million or $0.19 per share. For the quarter ending March 31st, 2026 versus the same prior year period:
- Research & development expense totaled $3.3 million, down 54% from $7.1 million, due to lower clinical trial costs and stock-based compensation. This was partially offset by higher manufacturing and supply chain costs related to the anticipated commercial launch. These costs included the purchase of raw cytisinicline inventory and the technology transfer to Adare;
- General & administrative expense was $7.2 million, up 24% from $5.8 million on higher legal expenses, employee expenses and commercial launch preparation. These were partially offset by a decrease in stock-based compensation expenses;
- Net interest income was $23,000 vs. $137,000 as greater debt balances offset interest income;
- Other expense of $0.3 million was related to change in fair value of contingent consideration and other expense;
- Net loss was $10.2 million vs. $12.8 million or $0.19 and $0.37 per share, respectively.
As of March 31st, 2026, cash and equivalents totaled $29.3 million. This compares to a $36.4 million balance held at the end of 2025. At the end of the first quarter, Achieve carried convertible debt of $14.9 million on the balance sheet. Cash used in operations during 1Q:26 was $6.9 million versus $11.1 million in the same prior year period. Following the end of the first quarter, on April 16th, 2026, Achieve announced a $180 million financing that was funded by a consortium of healthcare investors. It included warrants that could raise another $174 million upon FDA approval of cytisinicline. Based on management guidance, this approval could come in the first half of 2027.
New Executive and Board Members Added
New CEO Andrew Goldberg, MD, assumed the top spot at Achieve and was added to the company’s board of directors. Two other directors joined the board along with Dr. Goldberg, including Lucian Iancovici, MD, a managing director at TPG and Aaron Royston, MD, a managing partner at venBio. Announced alongside first quarter results, Dr. Iancovici was elevated to the role of Chairman of the Board and Christopher Martin was added to the board.
Other members were added to the executive team to strengthen the commercialization effort. Mark Zappia joined as Senior Vice President, Commercial and Jim Willis joined as Vice President of Sales and Sales Enablement where he will lead the field force. These individuals were part of the team at Verona Pharma where they led the commercial operations for the launch of Ohtuvayre, a therapy for chronic obstructive pulmonary disease (COPD) which has generated almost $550 million in revenues over the trailing four quarters and is expected to generate over $800 million in 2026.[1]
Shift to Adare Pharma Solutions
Manufacturing Modifications
Along with its 2025 earnings report released on March 24th, Achieve announced that it had developed a partnership with Adare Pharma Solutions, a domestic manufacturer of drug products. In a follow-up release, Achieve indicated that the unnamed manufacturer listed in its new drug application (NDA) had received two observations related to solid oral dose manufacturing. In a press release on April 15th, 2026, the company indicated that the FDA had issued an Official Action Indicated (OAI) classification to the unnamed manufacturer following a current Good Manufacturing Practices (cGMP) inspection.[2] Achieve management asserts that the OAI arose from general cGMP matters not related to cytisinicline. As a result, it believes that the FDA will issue a CRL for cytisinicline.
The relationship with Adare helps source domestically to avoid tariffs and sidestep the problematic OAI classification. Adare’s manufacturing facility is located in Vandalia, Ohio and significant progress has been made transferring cytisinicline manufacturing there. Achieve has completed the analytical transfer and has confirmed that the first cytisinicline engineering batch has been manufactured. Adare’s Chief Executive, Tom Sellig, sits on Achieve’s board of directors, providing a connection that should support rapid progress, communication and execution.
April 2026 Private Placement
Along with the announcement of Dr. Goldberg taking the CEO role, Achieve also executed a substantial capital raise. The deal provides $180 million of financing upfront and another $174 million potentially available from warrants exercisable within 20 days of FDA approval. If cytisinicline is successfully approved, this structure will generate the capital the company needs to expand sales efforts as first commercialization activities begin. The private placement issued 49,418,069 shares of common stock at $3.635 per share and 100,500 pre-funded warrants at $3.634 per pre-funded warrant. The transaction generated gross proceeds of $180 million.
One common warrant was attached to each share of common stock and prefunded warrant, bringing the total to 49,518,569 warrants. They may be exercised at $3.51 per share at any time after issuance and will expire 20 business days after FDA approval of cytisinicline for smoking cessation or two years after shareholder approval is given for an increase in the number of authorized shares of common stock.
Proceeds from the raise will be used to fund a Phase III trial for cytisinicline for e-cigarette cessation, the commercialization of cytisinicline and for working capital and general corporate purposes.
Investors participating in the deal include Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital Advisors and Marshall Wace and also includes participation from both new and existing investors, including Coastlands Capital, Dialectic Capital, Janus Henderson Investors, LifeSci Venture Partners, Logos Capital, Propel Bio Partners, Spruce Street Capital, Venrock Healthcare Capital Partners, Vivo Capital and Wellington Management. Morgan Stanley served as the sole placement agent for the transaction.
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[1] Estimates sourced from Evaluate, Ltd.
[2] An official action indicated (OAI) means regulatory and/or administrative actions are recommended. An OAI finding may result in warning letters, enforcement actions, or follow-up inspections. In clinical research, OAI classifications often relate to informed consent deficiencies, protocol noncompliance, or inadequate recordkeeping. Organizations must implement documented corrective and preventive actions (CAPA) to remediate issues.