ACHIEVE LIFE SCIENCES, INC.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
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Jun 30, 2026 · Filed Aug 11, 2026
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Notes to Consolidated Financial Statements (unaudited)
Notes to Consolidated Financial Statements
- NATURE OF BUSINESS, BASIS OF PRESENTATION AND LIQUIDITY RISK
Achieve Life Sciences, Inc. (referred to as “Achieve,” “we,” “us,” or “our”) is a late-stage clinical specialty pharmaceutical company with the sole mission to address the global nicotine dependence epidemic through the development and commercialization of cytisinicline. We were incorporated in the state of Delaware, and operate out of Bothell, Washington and Vancouver, British Columbia.
The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required to be presented for complete financial statements. The accompanying unaudited consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying consolidated Balance Sheet at December 31, 2025 has been derived from the audited consolidated financial statements included in our Annual Report on Form 10-K for the year then ended. The unaudited consolidated financial statements and related disclosures have been prepared with the assumption that users of the interim financial information have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2025 and filed with the U.S. Securities and Exchange Commission, or the SEC, on March 24, 2026.
The consolidated financial statements include the accounts of Achieve and our wholly owned subsidiaries, Achieve Life Sciences Technologies Inc., Achieve Life Science, Inc., Extab Corporation, or Extab, and Achieve Pharma UK Limited. All intercompany balances and transactions have been eliminated.
Liquidity Risk
We have historically experienced recurring losses from operations and have incurred an accumulated deficit of $345.2 million through June 30, 2026 and $260.2 million through December 31, 2025. As of June 30, 2026 and December 31, 2025, we had cash, cash equivalents and marketable securities of $187.3 million and $36.4 million, respectively. As of June 30, 2026, we had a negative working capital balance of $9.4 million. As of December 31, 2025 we had a positive working capital balance of $30.8 million. For thesix months ended June 30, 2026, we incurred a net loss of $84.9 million and net cash used in operating activities was $17.7 million. For the six months ended June 30, 2025, we incurred a net loss of $25.5 million and net cash used in operating activities was $20.2 million.
We have historically financed our operations through equity offerings, debt financings and government grants. While we believe that we will be able to settle our commitments and liabilities in the normal course of business as they fall due during the next 12 months, as a late-stage clinical specialty pharmaceutical company with no current sources of revenue, we are dependent on our ability to raise funds (through public or private securities offerings, debt financings, government funding or grants, or from other sources, which may include licensing, collaborations or other strategic transactions or arrangements) to support our ongoing clinical development and commercialization activities.
- ACCOUNTING POLICIES
Intangible Assets — Defensive Intangible Assets
We periodically acquire internet domain names for defensive purposes, to prevent their use by competitors and to protect our brand from third-party use and is not used actively in our operations. Such domain names are recognized as separate intangible assets, apart from goodwill, and are initially measured at cost, including the purchase price and direct costs incurred to acquire and register the domain. Although we do not intend to actively use these domain names and the underlying registrations are indefinitely renewable, defensive intangible assets are not assigned an indefinite useful life. Consistent with ASC 350 "Intangibles - Goodwill and Other," we estimate a finite useful life for each defensive domain name based on the expected period over which the domains' defensive values are expected to continue and indirectly benefit us. These assets are amortized on a straight-line basis over their estimated useful lives. Defensive intangible assets are tested for impairment in accordance with our policy for other finite-lived intangible assets — that is, whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, rather than through an annual indefinite-lived impairment test. Such indicators may include a change in our assessment of the continued strategic need to hold the domain name defensively, or a decision to cease renewing the underlying registration.
Fair value of financial instruments
We determine the fair value of our warrant liability based on the Black-Scholes pricing model and using considerable judgment, including estimating stock price volatility and expected warrant life.
Warrants
We have warrants classified on the consolidated balance sheet as a liability, which are revalued at each balance sheet date subsequent to the initial issuance. Determining the appropriate fair-value model and calculating the fair value of warrants requires considerable judgment, including estimating stock price volatility and expected warrant life. We use the Black-Scholes pricing model to value the warrants. The computation of expected volatility was based on the historical volatility of shares of our common stock for a period that coincides with the expected life of the warrants. A small change in the estimates used may have a relatively large change in the estimated valuation. Changes in the fair value of the warrants are reflected in the consolidated statement of loss as gain (loss) on revaluation of warrants.
- INTANGIBLE ASSETS
License Agreements
Our intangible assets related to license agreements are subject to amortization and are amortized using the straight-line method over their estimated useful life.
We acquired license and supply agreements in relation to cytisinicline upon the acquisition of Extab, on May 18, 2015. The agreements were determined to have a fair value of $3.1 million with an estimated useful life of 14 years.
The components of intangible assets were as follows (in thousands):
| June 30, 2026 | December 31, 2025 | |||||
|---|---|---|---|---|---|---|
| Gross Carrying | Accumulated | Net Carrying | Gross Carrying | Accumulated | Net Carrying | |
| Value | Amortization | Value | Value | Amortization | Value | |
| License Agreements | $3,117 | $(2,477) | $640 | $3,117 | $(2,366) | $751 |
For the three and six months ended June 30, 2026 we recorded license agreement amortization expense of $0.1 million and $0.1 million, respectively. For thethree and six months ended June 30, 2025 we recorded license agreement amortization expense of $0.1 million and $0.1 million, respectively. The following table outlines the estimated future amortization expense related to intangible assets held as of June 30, 2026 (in thousands):
| Year Ending December 31, | |
|---|---|
| 2026 | 112 |
| 2027 | 223 |
| 2028 | 223 |
| 2029 | 82 |
| Total | $640 |
Other Intangible Assets — Domain Name Defensive Intangible Assets
We acquire internet domain names to prevent their use by competitors and to protect our brand from third-party use. The domain names are not actively used in our operations. Accordingly, the asset has been classified as a defensive intangible asset in accordance with ASC 350-30.
Althoughwe have no current plan to actively use the domains and the underlying registrations are indefinitely renewable, the assets do notqualify for an indefinite useful life. We estimated a useful life of 14 years based on the expected period over which the domains' defensive values are expected to continue and indirectly benefit us. The assets are amortized on a straight-line basis over this period.
As of June 30, 2026, the domain name intangible assets consisted of the following:
| June 30, 2026 | December 31, 2025 | |||||
|---|---|---|---|---|---|---|
| Gross Carrying | Accumulated | Net Carrying | Gross Carrying | Accumulated | Net Carrying | |
| Value | Amortization | Value | Value | Amortization | Value | |
| Domain Names | $170 | $(1) | $169 | $— | $— | $— |
The following table outlines the estimated future amortization expense related to intangible assets held as of June 30, 2026 (in thousands):
| Year Ending December 31, | |
|---|---|
| 2026 | 6 |
| 2027 | 12 |
| 2028 | 12 |
| 2029 | 12 |
| 2030 | 12 |
| Thereafter | 115 |
| Total | $169 |
Intangible Assets Impairment Analysis
We evaluate the carrying amount of intangible assets periodically by taking into account events or circumstances that may warrant revised estimates of useful life or that indicate the asset may be impaired. We conducted an analysis of potential impairment indicators for long lived assets, including the license and supply agreements for the active pharmaceutical ingredient cytisinicline and Domain Name Defensive Intangible Assets, and concluded that there wereno indicators of impairment identified as of June 30, 2026.
- LICENSE AGREEMENTS
Sopharma License and Supply Agreements
We are party to a license agreement, or the Sopharma License Agreement, and a supply agreement, or the Sopharma Supply Agreement, with Sopharma. Pursuant to the Sopharma License Agreement, we were granted access to all available manufacturing, efficacy and safety data related to cytisinicline. Additional rights granted under the Sopharma License Agreement include the exclusive use of, and the right to sublicense, certain Sopharma patent rights and the trademark Tabex in all territories described in the Sopharma License Agreement. Under the Sopharma License Agreement, we agreed to pay a nonrefundable license fee. In addition, we agreed to make certain royalty payments equal to a mid-single digit percentage of all net sales of Tabex branded products in our territory during the term of the Sopharma License Agreement, including those sold by a third party pursuant to any sublicense which may be granted by us. We have agreed to coordinate with Sopharma in the defense against any actual or threatened infringement claims with respect to Tabex branded products. The Sopharma License Agreement will terminate under customary termination provisions including bankruptcy or insolvency and material breach. To date, any amounts paid to Sopharma pursuant to the Sopharma License Agreement have been immaterial.
We communicated to Sopharma that we had concerns regarding their ability to pass an FDA pre-approval inspection and that if those concerns were not resolved, we planned to utilize third-party manufacturers, and include such manufacturers in our NDA, until such time that Sopharma is able to pass an FDA inspection. In June 2025, we submitted our NDA, which included third-party manufacturers. Sopharma has alleged that our planned utilization of third-party manufacturers is a breach of our agreement, which we have disputed. In July 2026, Sopharma filed an arbitration demand alleging breach of the Sopharma Supply Agreement. Sopharma seeks actual, compensatory, incidental, and consequential damages; costs and attorneys’ fees; restitution; declaratory relief; and an order requiring us to include Sopharma as our designated manufacturer in any future NDA submission. We dispute these claims and intend to defend the matter vigorously. Based on the information currently available, we are unable to reasonably estimate the amount or range of any potential loss at this time because the arbitration is in its early stages. Accordingly, no liability has been recorded in the accompanying consolidated financial statements related to this matter as of June 30, 2026.
Share Purchase Agreement
On May 14, 2015, we entered into a Share Purchase Agreement with Sopharma to acquire 75% of the outstanding shares of Extab for $2.0 million in cash and $2.0 million in a deferred payment, contingent on regulatory approval of cytisinicline by the FDA or the European Medicines Agency. The fair value of the contingent consideration on the acquisition date was nil. The contingent consideration liability is measured at fair value in our financial statements.
As of June 30, 2026, the fair value of the contingent consideration was estimated to be $1.4 million. We recognized a loss of $0.1 million and a gain of $0.2 million for thethree and six months ended June 30, 2026, respectively, and a loss of $0.1 million and $0.2 million for the three and six months ended June 30, 2025, respectively.
- FAIR VALUE MEASUREMENTS
Assets and liabilities recorded at fair value in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair value. For certain of our financial instruments including amounts receivable and accounts payable the carrying values approximate fair value due to their short-term nature.
ASC 820 “Fair Value Measurements and Disclosures” specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. In accordance with ASC 820, these inputs are summarized in the three broad levels listed below:
Level 1 – Quoted prices in active markets for identical securities.
Level 2 – Other significant inputs that are observable through corroboration with market data (including quoted prices in active markets for similar securities).
Level 3 – Significant unobservable input that reflects management’s best estimate of what market participants would use in pricing the asset or liability.
As quoted prices in active markets are not readily available for certain financial instruments, we obtain estimates for the fair value of financial instruments through third-party pricing service providers.
In determining the appropriate levels, we performed a detailed analysis of the assets and liabilities that are subject to ASC 820.
We invest our excess cash in accordance with investment guidelines that limit the credit exposure to any one financial institution other than securities issued by the U.S. Government. These securities are not collateralized and mature withinone year. No expected credit loss has been taken against these securities.
A description of the valuation techniques applied to our financial instruments measured at fair value on a recurring basis follows.
Financial Instruments
The following table presents information about our assets and liabilities that are measured at fair value on a recurring basis, and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value (in thousands):
| June 30, 2026 | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| Assets | ||||
| Money market securities (cash equivalents) | $45,378 | $— | $— | $45,378 |
| Corporate bonds and commercial paper (cash equivalents) | — | 1,993 | — | 1,993 |
| Restricted cash | 235 | — | — | 235 |
| U.S. government securities | — | 47,921 | — | 47,921 |
| Corporate bonds (marketable securities) | — | 23,803 | — | 23,803 |
| Commercial paper (marketable securities) | — | 67,621 | — | 67,621 |
| Total assets | $45,613 | $141,338 | $— | $186,951 |
| Liabilities | ||||
| Convertible debt | $— | $14,507 | $— | $14,507 |
| Contingent consideration | — | — | 1,372 | 1,372 |
| Warrant liability | — | — | 182,724 | 182,724 |
| Pre-funded warrant liability | — | — | 655 | 655 |
| Total liabilities | $— | $14,507 | $184,751 | $199,258 |
Money Market Securities
Money market securities are classified within Level 1 of the fair value hierarchy and are valued based on quoted prices in active markets for identical securities.
Money market securities consist of the following (in thousands):
| Gross · Gross | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| June 30, 2026 | Cost | Gains | Losses | Fair Value |
| Money market securities (cash equivalents) | $45,378 | $— | $— | $45,378 |
| Money market securities (restricted cash) | 235 | — | — | 235 |
| Total money market securities | $45,613 | $— | $— | $45,613 |
We only invest in A (or equivalent) rated securities. All securities included in cash and cash equivalents had maturities of 90 days or less at the time of purchase.
Corporate and Other Debt Corporate Bonds and Commercial Paper
The fair value of corporate bonds and commercial paper is estimated using recently executed transactions, market price quotations (where observable), bond spreads or credit default swap spreads adjusted for any basis difference between cash and derivative instruments. The spread data used are for the same maturity as the bond. If the spread data does not reference the issuer, then data that reference a comparable issuer are used. When observable price quotations are not available, fair value is determined based on cash flow models with yield curves, bond or single name credit default swap spreads and recovery rates based on collateral values as significant inputs. Corporate bonds and commercial paper are generally categorized in Level 2 of the fair value hierarchy; in instances where prices, spreads or any of the other aforementioned key inputs are unobservable, they are categorized in Level 3 of the hierarchy.
| Gross · Gross | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| June 30, 2026 | Cost | Gains | Losses | Fair Value |
| Corporate bonds and commercial paper (cash equivalents) | $1,993 | $— | $— | $1,993 |
| U.S. government securities | 47,959 | — | (38) | 47,921 |
| Corporate bonds | 23,830 | — | (27) | 23,803 |
| Commercial paper | 67,649 | — | (28) | 67,621 |
| Total commercial paper | $141,431 | $— | $(93) | $141,338 |
Concentration of Cash and Cash Equivalents Risk
We place our cash in a custodial account and in commercial checking and sweep accounts with various financial institutions.
As of June 30, 2026, approximately $164.6 million in cash equivalents and marketable securities is held in a custodial account with U.S. Bank, for which SVB Asset Management is the advisor; and approximately $0.1 million of our cash and $21.6 million of our cash equivalents is held in a single financial institution, Silicon Valley Bank, or SVB, as required by the covenants of the Debt Agreement (see Note 6 – "Convertible Debt").
Our commercial bank balances exceed federal insurance limits. We have not experienced any losses in our cash and cash equivalents for the six months ended June 30, 2026 and 2025.
Concentration of Credit Risk
For certain of our financial instruments, including cash and cash equivalents, accounts payable, accrued liabilities other, accrued clinical liabilities and accrued compensation, carrying values approximate fair value due to their short-term nature. Our cash equivalents are recorded at fair value.
Financial risk is the risk to our results of operations that arises from fluctuations in interest rates and foreign exchange rates and the degree of volatility of these rates as well as credit risk associated with the financial stability of the issuers of the financial instruments. Foreign exchange rate risk arises as a portion of our expenses are denominated in other than U.S. dollars.
We invest our excess cash in accordance with investment guidelines, which limit our credit exposure for securities to any one financial institution or corporation other than securities issued by the U.S. government. We only invest in A (or equivalent) rated securities with maturities of one year or less. These securities generally mature within one year or less and in some cases are not collateralized. At June 30, 2026, the average days to maturity of our portfolio of cash equivalents and marketable securities was 122 days. We do not use derivative instruments to hedge against any of these financial risks.
Fair Value of Debt
The principal amount, carrying value and related estimated fair value of our convertible debt reported in the consolidated balance sheets as of June 30, 2026 and December 31, 2025 was as follows (in thousands). The aggregate fair value of the principal amount of the convertible debt is a Level 2 fair value measurement.
| June 30, 2026 | December 31, 2025 | |||||
|---|---|---|---|---|---|---|
| Principal | Carrying | Fair | Principal | Carrying | Fair | |
| Amount | Value | Value | Amount | Value | Value | |
| 2024 SVB Convertible Debt | $15,000 | $14,912 | $14,507 | $15,000 | $14,889 | $14,320 |
Fair Value of Sopharma Share Purchase Agreement Contingent Consideration
We determine the fair value of the contingent consideration using a probability based discounted cash flow model whereby we forecast the timing of the cash flow of the related future payment based on cytisinicline’s current clinical development phase and the remaining requirements for regulatory approval. We then discount the expected payment amount to calculate the present value and then apply a probability of success in obtaining regulatory approval as of the valuation date. We evaluate the underlying projection used in determining the fair value each period and make updates as necessary.
The significant assumptions we use to value the contingent consideration are the forecasted timing of the future payment, the risk-adjusted discount rate and the probability of success which are all considered significant unobservable inputs, and as such, the liability is classified as a Level 3 measurement. The risk-adjusted discount rate is adjusted for credit risk.
An increase in the discount rate and decrease in the probability of success will result in a decrease in the fair value of the contingent consideration. Conversely, a decrease in the discount rate and increase in the probability of success will result in an increase in the fair value of the contingent consideration. As of June 30, 2026 the risk adjusted discount rate was 30.8% and the probability of success was 90.6%. Adjustments to the fair value of the contingent liabilities, other than payments, are recorded as a gain or loss in the Consolidated Statements of Loss and Comprehensive Loss.
The following table presents the changes in fair value of our total Level 3 financial liabilities for thesix months ended June 30, 2026 (in thousands):
| Balance at | Change in | Balance at | |
|---|---|---|---|
| (in thousands) | December 31, 2025 | Fair Value | June 30, 2026 |
| Contingent consideration | $1,557 | $(185) | $1,372 |
Fair Value of Liability Classified Warrants and Pre-Funded Warrants
As of June 30, 2026, we recorded a $182.7 million warrant liability. We reassess the fair value of our common stock warrants and pre-funded common stock warrants classified as liabilities at each reporting date.
We determine the fair value of our liability classified common stock warrants utilizing the Black-Scholes pricing model. Inputs used in the pricing model include estimates of stock price volatility, expected warrant life and risk-free interest rate. The computation of expected volatility is based on the historical volatility of shares of our common stock for a period that coincides with the expected life of the warrants that are classified as liabilities. Warrants that are classified as liabilities are categorized in Level 3 of the fair value hierarchy. A small change in the estimates used may result in a relatively large change in the estimated valuation. Warrants that are classified as equity are not considered liabilities and therefore are not reassessed for their fair values at each reporting date.
The inputs and significant assumptions used in Black-Scholes pricing model were as follows:
| As of · Six Months Ended | |||
|---|---|---|---|
| April 17, · June 30, | |||
| 2026 | 2026 | 2025 | |
| Risk-free interest rates | 3.62% | 3.94% | — |
| Expected dividend yield | 0% | 0% | — |
| Expected life | 1.17 years | 0.97 years | — |
| Expected volatility | 98.98% | 90.90% | — |
| Forfeiture rate | 0.00% | 0.00% | — |
The liability classified pre-funded warrants do not have an expiration date and we determine their fair value to approximate the underlying equity share because the exercise price is considered to be de minimis at $0.001.
During thesix months ended June 30, 2026, we issued 49.5 million common stock warrants and 0.1 million pre-funded common stock warrants that were classified as liabilities. The following table presents the changes in fair value of our total Level 3 financial liabilities for thesix months ended June 30, 2026 (in thousands):
| Liability at | Issuance of | Unrealized Loss on | Liability at | |
|---|---|---|---|---|
| December 31, 2025 | Warrants | Warrants | June 30, 2026 | |
| Warrant Liability | $— | $134,196 | $48,528 | $182,724 |
| Pre-funded Warrant Liability | — | 511 | 144 | 655 |
| $— | $134,707 | $48,672 | $183,379 |
- CONVERTIBLE DEBT
On July 25, 2024, we entered into a contingent convertible debt agreement, or New Debt Agreement with SVB, a division of First-Citizens Bank & Trust Company, or FCB, in its capacity as administrative agent and collateral agent, and FCB, as a lender, or Lender, pursuant to which the Lender provided term loans having an aggregate original principal amount of $10.0 million, with additional term loans of up to $10.0 million available upon the occurrence of certain events as provided for in the New Debt Agreement and further described below, or New Convertible Term Loan. Our obligations under the New Debt Agreement are secured by substantially all of our assets, other than intellectual property.
The New Convertible Term Loan matures on June 1, 2028. The first tranche of the New Convertible Term Loan, which was advanced on July 25, 2024, has an aggregate original principal amount of $10.0 million. The Lender made available to us, upon our request: (a) prior to October 31, 2025, a second tranche of the New Convertible Term Loan having an aggregate principal amount of $5.0 million in the event that we received written notice that the FDA had accepted for filing our NDA with respect to cytisinicline for a smoking cessation indication, or the Additional Term Loan Event I, and (b) on or prior to December 31, 2025, a third tranche of the New Convertible Term Loan having an aggregate principal amount of $5.0 million, subject to the Lender’s sole discretion.
In October 2025, pursuant to the New Debt Agreement and following the occurrence of the Additional Term Loan Event I as described therein, we drew down on the second tranche of the New Convertible Term Loan for an additional $5.0 million. We did not draw down on the third tranche of the New Convertible Term Loan and it expired and became unavailable on December 31, 2025.
Interest is calculated on the outstanding principal amount of the New Convertible Term Loan at a floating rate per annum equal to the greater of (i)7.0% and (ii) the prime rate minus 1.0%, which interest shall be payable in cash monthly in arrears and shall be payable on the earlier to occur of (x) the first day of the first month following any extension of credit by the Lender for our credit, (y) the date ofany prepayment pursuant to the New Debt Agreement, or (z) the maturity date. The New Convertible Term Loan was “interest-only” through June 30, 2026.
Subject to certain terms and conditions, the conversion feature grants the Lender or, pursuant to an assignment, any designee thereof, or Conversion Right Holders, the right to convert part or all of the outstanding aggregate original principal amount of the New Convertible Term Loan, plus accrued and unpaid interest, into shares of our common stock at a conversion price equal to $7.00, subject to customary adjustment provisions. The Conversion Right Holders have the further right to convert part or all of the outstanding principal amount of the second tranche of the New Convertible Term Loan, plus accrued and unpaid interest, into shares of our common stock at aconversion price equal to the greater of (i) $4.854, subject to customary adjustment provisions, and (ii) the lower of (a)150% of the average of the closing sale price of our common stock during the 10 trading days preceding the effective date of such tranche and (b)150% of the closing sale price of our common stock on the trading day immediately preceding the effective date of such tranche.
The conversion rights may be exercised at each Conversion Right Holder's option any time prior to repayment of the New Convertible Term Loan; provided, however, that the Conversion Right Holders will not be permitted to convert part or all of the outstanding aggregate original principal amount of the New Convertible Term Loan without the agreement of the relevant Conversion Right Holder and us if the sum of the amount of debt to be converted; and the aggregate amount of debt previously converted pursuant to any such voluntary conversion, divided by the aggregate of all debt that is then outstanding or that has been repaid other than by conversion exceeds 50%.
Additionally, the outstanding principal of the New Convertible Term Loan, plus accrued and unpaid interest, will automatically be converted into shares of our common stock at the applicable conversion price on such date if any, when the closing price per share of our common stock has been equal to or greater than (a) in the case of the outstanding aggregate original principal amount of the New Convertible Term Loan, plus accrued and unpaid interest, $24.00 or, (b) in the case of the outstanding principal amount of the second tranche of the New Convertible Term Loan, plus accrued and unpaid interest, three times the applicable conversion price, in each case for the thirty consecutive trading days prior to such date, and the Liquidity Conditions (as defined in the New Debt Agreement) have been satisfied.
The New Convertible Term Loan may be repaid at our election and upon notice to the Agent (as defined in the New Debt Agreement) by paying the Lender an amount equal to (i) a prepayment fee equal to (a)3.0% of the aggregate outstanding principal balance if such prepayment occurs on or prior to the first anniversary of the New Convertible Term Loan, (b)2.0% of the aggregate outstanding principal balance if such prepayment occurs after the first anniversary, but on or prior to the second anniversary, of the New Convertible Term Loan or (c)1.0% of the aggregate outstanding principal balance if such prepayment occurs after the second anniversary of the New Convertible Term Loan and before the maturity date; (ii)4.0% of the original aggregate principal amount of the New Convertible Term Loan and (iii) all other sums due and payable under the New Convertible Term Loan.
The New Debt Agreement contains customary affirmative and restrictive covenants, including covenants regarding the incurrence of additional indebtedness or liens, investments, transactions with affiliates, delivery of financial statements, payment of taxes, maintenance of insurance, dispositions of property, mergers or acquisitions, among other customary covenants. We are also restricted from paying dividends or making other distributions or payments on our capital stock, subject to limited exceptions. The New Debt Agreement also includes customary representations and warranties, events of default and termination provisions. The Lender may not engage in any short sales of, or other hedging transactions in, our common stock while any amounts are outstanding under the New Debt Agreement. As of June 30, 2026, we are in compliance with all covenants under the New Debt Agreement.
In connection with the New Debt Agreement, we entered into a Registration Rights Agreement, or RRA, with the Lender, pursuant to which we registered for resale shares of our common stock issuable to the Conversion Right Holders upon the conversion of outstanding debt under the New Debt Agreement. Our obligations under the RRA will terminate with respect to a holder of applicable registrable securities if, as of the date we would be required to provide written notice of such registration, (x) the aggregate number of registrable securities then issued and issuable to such holder and to such holder’s affiliates, together with all other shares then held beneficially and/or of record by such holder and its affiliates, does not exceed 7.0% of our then-total shares issued and outstanding (calculated including all such registrable securities and other shares), or (y) we and such holder mutually reasonably agree that all registrable securities then issued and issuable to such holder and its affiliates may then be sold by such holder without the requirement to be in compliance with Rule 144 promulgated under the Securities Act, or Rule 144, and otherwise without restriction or limitation pursuant to Rule 144.
Under ASU 2020-06 the embedded conversion feature was not required to be bifurcated and recognized separately, as a result the convertible debt including the conversion feature has been recognized as a single unit of debt.
The debt refinancing under the New Debt Agreement was recognized as an extinguishment of debt under ASC 470-50, and the difference between the reacquisition price and carrying value was recognized on the Consolidated Statement of Loss as a loss on extinguishment of debt. Associated third-party issuance costs have been recognized against the single unit of debt and will be amortized into interest expense over the term of the loan.
As of June 30, 2026 and December 31, 2025, the New Convertible Term Loan balance was comprised of the following (in thousands):
| June 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| New Convertible Term Loan Information | ||
| Principal | $15,000 | $15,000 |
| Transaction costs | (186) | (186) |
| Amortization of transaction costs | 98 | 75 |
| $14,912 | $14,889 | |
- COMMON STOCK
[a] Authorized
150,000,000 authorized common shares, par value of $0.001, and 5,000,000 preferred shares, par value of $0.001.
[b] Issued and outstanding shares
February 2024 Registered Direct Offering and Concurrent Private Placement
In February 2024, we entered into a securities purchase agreement with certain purchasers, pursuant to which we sold 13,086,151 shares of common stock at a price of $4.585 per share in a registered direct offering. The offering of the shares was made pursuant to our shelf registration statement on Form S-3, including the prospectus dated January 5, 2022 contained therein, and the prospectus supplement dated February 28, 2024.
In a concurrent private placement, we issued unregistered warrants to purchase up to 13,086,151 shares of common stock at an exercise price of $4.906 per share (provided, however, that the purchaser may elect to exercise the warrants for pre-funded warrants in lieu of shares of common stock at an exercise price of $4.906, minus $0.001, the exercise price of each pre-funded warrant). These warrants are immediately exercisable for shares of common stock or pre-funded warrants in lieu thereof, and will expire in October 2025 on the earlier of (i) three and one-half years following the date of issuance and (ii) 30 days following our public disclosure of the acceptance of an NDA for cytisinicline by the FDA in a Day 74 Letter or equivalent correspondence, which date occurred in October 2025. The shares of common stock issuable upon exercise of the warrants (or pre-funded warrants, as applicable) were subsequently registered pursuant to our registration statement on Form S-3, which was declared effective on May 6, 2024.
The registered direct offering raised total gross proceeds of approximately $60.0 million, and after deducting approximately $3.9 million in placement agent fees and offering expenses, we received net proceeds of approximately $56.1 million.
June 2025 Public Offering
On June 26, 2025, we entered into an underwriting agreement, or Underwriting Agreement, with Citizens JMP Securities, LLC and Raymond James & Associates, Inc., or the Underwriters, as representatives of the underwriters, pursuant to which we agreed to issue and sell to the Underwriters 15,000,000 shares of our common stock, or the shares, and accompanying common warrants, or accompanying warrants, to purchase up to 15,000,000 shares of common stock, or warrant shares, or pre-funded warrants to purchase shares of our common stock in lieu thereof, or pre-funded warrants.
The shares and accompanying warrants were sold collectively at the public offering price of $3.00 per share and accompanying warrant, less underwriting discounts and commissions. Pursuant to the Underwriting Agreement, we also granted the Underwriters a 30-day option to purchase up to an additional 2,250,000 shares and/or up to an additional 2,250,000 accompanying warrants at the same public offering price per share and accompanying warrant, less underwriting discounts and commissions. On June 28, 2025, the Underwriters exercised their option in part to purchase an additional 1,766,666 accompanying warrants. On July 25, 2025, the Underwriters exercised their option in part to purchase an additional 1,419,896 shares.
Each accompanying warrant is exercisable, at the purchaser’s election, for either warrant shares at an exercise price of $3.00 per share or for pre-funded warrants at an exercise price of $2.999 per pre-funded warrant. The accompanying warrants are exercisable at any time after the date of issuance, subject to certain ownership limitations, and will expire on thefifth anniversary of the date of issuance. A holder of accompanying warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99%of the number of shares of our common stock outstanding immediately after giving effect to such exercise. The pre-funded warrants have an exercise price of $0.001 per share, will be immediately exercisable subject to certain ownership limitations, and have no expiration. A holder of pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of our common stock outstanding immediately after giving effect to such exercise. A holder of accompanying warrants and pre-funded warrants may increase or decrease the ownership limitation by providing at least 61 days' prior notice to us.
The June 2025 public offering of 15,000,000 shares and 15,000,000 accompanying warrants raised total gross proceeds of approximately $45.0 million, and after deducting approximately $3.8 million in underwriting discounts and offering expenses, we received net proceeds of approximately $41.2 million. The exercises in part of the Underwriters’ option to purchase 1,766,666 accompanying warrants and 1,419,896 shares raised gross proceeds of $4.3 million, and after deducting approximately $0.3 million in underwriting discounts, we received net proceeds of approximately $4.0 million.
April 2026 Private Placement
On April 15, 2026 we entered into a securities purchase agreement with certain institutional and accredited investors, or Investors, pursuant to which we sold and issued to the Investors in a private placement an aggregate of (i)49,418,069 shares, or shares, our common stock, and, in lieu of shares of our common stock for an Investor, pre-funded warrants to purchase up to 100,500 shares of our common stock, or pre-funded warrant shares, and (ii) accompanying warrants, or common warrants, to purchase up to 49,518,569 shares of our common stock or pre-funded warrants to purchase shares of our common stock, or common warrant shares, at a collective purchase price of (a) $3.635 per combination of shares and accompanying common warrants or (b) $3.634 per combination of pre-funded warrants and accompanying common warrants.
Each pre-funded warrant has an exercise price of $0.001 per pre-funded warrant share. The pre-funded warrants are exercisable at any time after their original issuance, subject to certain ownership limitations, and will not expire.
Each common warrant is exercisable at an exercise price of $3.51 per common warrant share. The common warrants are exercisable at any time after the date of issuance, subject to certain ownership limitations, and will expire on the later of the twentieth business day following (i) the date on which we publicly announce that the FDA has approved cytisinicline for smoking cessation in adults, or FDA Approval, and (ii) the date on which we notify the common warrant holders of the FDA Approval, provided that if a common warrant is not fully exercisable because we have insufficient authorized and unreserved shares of our common stock at the time of the public announcement of the FDA Approval, the common warrant will be exercisable for two years following the date on which we obtain stockholder approval for an amendment to our certificate of incorporation to increase the number of authorized shares of our common stock.
A holder of common warrants or pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99%,9.99% or 19.99%, at the election of the holder (provided that no holder may beneficially own more than 19.99%), or the Ownership Limitation, of the number of shares of our common stock outstanding immediately after giving effect to such exercise. A holder of common warrants or pre-funded warrants may generally increase or decrease the Ownership Limitation by providing at least 61 days’ prior notice to us. A holder of common warrants or pre-funded warrants also may not exercise the common warrants or pre-funded warrants, as applicable, for shares of our common stock if we do not have sufficient authorized and unissued shares of our common stock to issue such shares of our common stock upon exercise.
In connection with the private placement, on April 15, 2026, the Board appointed Andrew D. Goldberg, M.D. as our Chief Executive Officer, or CEO, and President, and as a member of the Board, effective April 18, 2026.
We received net proceeds of approximately $168.2 million after deducting estimated placement agent fees and other expenses of approximately $11.8 million, allocated as follows:
| Pre-funded | |||
|---|---|---|---|
| Common | Common Stock | Common Stock | |
| Stock | Warrants | Warrants | |
| Unit Issued | 49,418,069 | 100,500 | 49,518,569 |
| Gross Proceeds (in thousands) | $45,293 | $511 | $134,196 |
| Underwriting discount and offering expense (in thousands) | $2,958 | $33 | $8,766 |
The common stock warrants and pre-funded warrants issued in the April 2026 Private Placement are classified as liabilities. Theplacement agent fees and other expenses allocated to the common stock warrants and pre-funded warrants have been expensed in the Consolidated Statement of Loss.
The shares of common stock issued in the April 2026 Private Placement are classified as equity. Theplacement agent fees and other expenses allocated to the shares of common stock have been charged against the allocated gross proceeds.
[c] Equity Awards
2024 Equity Inducement Plan
As of June 30, 2026, we had reserved, pursuant to the 2024 Equity Inducement Plan,23,173,538 shares of common stock for issuance upon exercise of stock options and settlement of restricted stock units by employees, of which 5,203,533 shares were reserved for options currently outstanding,13,507,235 shares were reserved for restricted stock units currently outstanding, and 4,462,770 shares were available for future equity grants.
Under the 2024 Equity Inducement Plan, we may grant options to purchase shares of our common stock or restricted stock units as a material inducement to new employees to enter into employment with us. The exercise price of the options is determined by our board of directors, or Board, but will be at least equal to the fair value of the shares of common stock on the grant date. The options vest in accordance with terms as determined by our Board. The expiration date for each option is set by our Board with a maximum expiration date often years from the date of grant. In addition, the 2024 Equity Inducement Plan allows for accelerated vesting of outstanding equity awards in the event of a change in control.
2023 Non-Employee Director Equity Incentive Plan
As of June 30, 2026, we had reserved, pursuant to the 2023 Non-Employee Director Equity Incentive Plan,300,000 shares of common stock for issuance upon exercise of stock options by non-employee directors, of which 227,250 shares were reserved for options currently outstanding and 72,750 shares were available for future equity grants.
Under the 2023 Non-Employee Director Equity Incentive Plan, we may grant options to purchase shares of our common stock or restricted stock units to our non-employee directors. The exercise price of the options is determined by our Board, but will be at least equal to the fair value of the shares of common stock at the grant date. The options vest in accordance with terms as determined by our Board, typically overone tothree years. The expiration date for each option is set by our Board with a maximum expiration date often years from the date of grant. In addition, the 2023 Non-Employee Director Equity Incentive Plan allows for accelerated vesting of outstanding equity awards in the event of a change in control.
2018 Equity Incentive Plan
As of June 30, 2026, we had reserved, pursuant to the 2018 Equity Incentive Plan, or the 2018 Plan,5,550,225 shares of common stock for issuance upon exercise of stock options and settlement of restricted stock units by employees, directors, officers and consultants of ours, of which 3,733,128 were reserved for options currently outstanding,971,830 for restricted stock units currently outstanding, and 845,267 were available for future equity grants.
Under the 2018 Plan, we may grant options to purchase common shares or restricted stock units to our employees, directors, officers and consultants. The exercise price of the options is determined by our Board, but will be at least equal to the fair value of the shares of common stock at the grant date. The options vest in accordance with terms as determined by our Board, typically over three tofour years for options issued to employees and consultants, and overone tothree years for members of our Board. The expiration date for each option is set by our Board with a maximum expiration date often years from the date of grant. In addition, the 2018 Plan allows for accelerated vesting of outstanding equity awards in the event of a change in control. The terms for accelerated vesting, in the event of a change in control, is determined at our discretion and defined under the employment agreements for our officers and certain of our employees.
New Employee Inducement Grants
We grant stock options as a material inducement to new employees to enter into employment agreements with us in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options approved under the inducement grants are issued pursuant to a stock option agreement on terms substantially similar to those described in our 2018 Plan. The exercise price of the options is determined by our Board but will be at least equal to the fair value of the common shares at the grant date. The options vest in accordance with terms as determined by our Board. The expiration date for each option is set by our Board with a maximum expiration date often years from the date of grant. For thethree and six months ended June 30, 2026, we didnot grant any inducement stock options to new employees in accordance with Nasdaq Listing Rule 5635(c)(4)outside of the 2024 Equity Inducement Plan. As of June 30, 2026,125,000 stock options granted as new employee inducement grants were outstanding.
2017 Equity Incentive Plan
As of June 30, 2026, we had reserved, pursuant to the 2017 Equity Incentive Plan, or the 2017 Plan,10,536 shares of common stock for issuance upon exercise of currently outstanding stock options by employees, directors and officers of ours. Upon the effectiveness of our 2018 Plan, we ceased granting equity awards under our 2017 Plan.
Stock Option Summary
We grant stock options that vest over time in accordance with terms as determined by our Board, which are typically four years for employee and consultant grants andone tothree years for Board option grants. We also grant stock option awards that vest in conjunction with certain performance conditions to executive officers, employees and consultants. At each reporting date, we are required to evaluate whether achievement of the performance conditions is probable. Compensation expense is recorded over the appropriate service period based upon our assessment of accomplishing each performance condition. The expiration date for each option is set by our Board, which is typically seven toten years. The exercise price of the options is determined by our Board.
Stock option transactions and the number of stock options outstanding are summarized below:
| Number of | Weighted | |
|---|---|---|
| Optioned | Average | |
| Common | Exercise | |
| Shares | Price | |
| Balance, December 31, 2025 | 2,730,211 | $7.08 |
| Granted | 7,028,579 | 4.49 |
| Expired | (20) | 2,200.00 |
| Exercised | (31,248) | 3.65 |
| Cancelled/Forfeited | (428,075) | 4.38 |
| Balance, June 30, 2026 | 9,299,447 | $5.26 |
The fair value of each stock award for employees and directors is estimated on the grant date and for consultants at each reporting period, using the Black-Scholes option-pricing model based on the weighted-average assumptions noted in the following table:
| Six Months Ended | ||
|---|---|---|
| June 30, | ||
| 2026 | 2025 | |
| Risk-free interest rates | 3.91% | 4.31% |
| Expected dividend yield | 0% | 0% |
| Expected life | 6.01 years | 5.63 years |
| Expected volatility | 76.88% | 78.31% |
| Forfeiture rate | 0.00% | 0.00% |
The expected life was calculated based on the simplified method as permitted by the SEC’s Staff Accounting Bulletin 110, Share-Based Payment. We consider the use of the simplified method appropriate because of the lack of sufficient historical exercise data following the 2017 Merger Agreement between Achieve Life Sciences, Inc. and OncoGenex Pharmaceuticals. The computation of expected volatility was calculated based on the historical volatility of the shares of our common stock. The risk-free interest rate is based on a U.S. Treasury instrument whose term is consistent with the expected life of the stock options. In addition to the assumptions above, as required under ASC 718, management made an estimate of expected forfeitures and is recognizing compensation costs only for those equity awards expected to vest. Forfeiture rates are estimated using historical actual forfeiture rates.
These rates are adjusted on a quarterly basis and any change in compensation expense is recognized in the period of the change. We have never paid or declared cash dividends on our common stock and do not expect to pay cash dividends in the foreseeable future.
The results for the periods set forth below included stock-based compensation expense for stock options, restricted stock units and employee share purchase plan compensation expenses in the following expense categories of the consolidated statements of loss (in thousands):
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $460 | $779 | $(10) | $1,333 |
| General and administrative | 6,495 | 2,109 | 6,280 | 3,787 |
| Total stock-based compensation | $6,955 | $2,888 | $6,270 | $5,120 |
As of June 30, 2026, the total unrecognized compensation expense related to stock options granted was $16.8 million, which is expected to be recognized as expense over a period of approximately 3.49 years from June 30, 2026.
Rescindable Stock Option Grants
During the six months ended June 30, 2026, we granted options to purchase 975,000 shares of common stock to certain employees, subject to and contingent upon stockholder approval of an increase in the number of authorized shares of common stock. Under the terms of the award agreements, if such approval was not obtained by May 11, 2027, the grants would be automatically rescinded and no shares would be issued.
Because stockholder approval of the share increase is considered a substantive condition under ASC 718, the grant date for accounting purposes has not yet occurred as of June 30, 2026, and no compensation cost has been recognized for these awards during the period then ended. We will establish the accounting grant date, measure the grant-date fair value of the awards, and begin recognizing compensation cost over the requisite service period upon receipt of stockholder approval.
As of June 30, 2026,975,000 options remain outstanding and unrecognized as accounting grant-date awards, with a weighted-average exercise price of $5.59, based on the stock price on the date the awards were communicated to employees. The actual grant-date fair value may differ once stockholder approval is obtained and measurement occurs.
Subsequent to June 30, 2026, on July 2, 2026, our stockholders approved an increase in authorized shares of common stock. Accordingly, the accounting grant date for these awards was established as July 2, 2026, and we will recognize compensation cost over the remaining requisite service period beginning on that date (see Note 10 "Subsequent Events").
Restricted Stock Unit Awards Summary
We grant restricted stock unit awards that generally vest and are expensed over afour-year period. We also grant restricted stock unit awards that vest in conjunction with certain performance conditions to certain executive officers, key employees and consultants. At each reporting date, we are required to evaluate whether achievement of the performance conditions is probable. Compensation expense is recorded over the appropriate service period based upon our assessment of accomplishing each performance condition. For thethree and six months ended June 30, 2026, we recognized compensation expense of $4.5 million and a $3.0 million, respectively. This is compared to compensation expense of $2.4 million and $4.2 million, respectively, for thethree and six months ended June 30, 2025.
CEO Market Condition RSUs
During the three and six months ended June 30, 2026, we granted 11,706,270 RSUs to our CEO and President that vest based on market conditions tied to the achievement of eight share price milestones ranging from 2x to 9x of a reference price. Because the vesting condition is based on the price of our shares, the market condition is incorporated directly into the measurement of grant-date fair value, rather than assessed for probability of achievement in subsequent periods. We estimated the grant-date fair value of these awards using a Monte Carlo simulation model. The model simulates a large number of independent share price paths, approximately 100,000 iterations. For each simulated path, the model determines whether and to what extent the market condition would be satisfied and calculates the resulting payout under the award's vesting schedule. The grant-date fair value represents the average of the discounted payouts across all simulated paths.
The inputs and significant assumptions used in the Monte Carlo simulation were as follows:
| Inputs and Assumptions | |
|---|---|
| Valuation date | April 18, 2026 |
| Underlying share price | $5.10 |
| Risk free interest rate | 3.82% |
| Contractual term | April 18, 2036 |
| Volatility estimate | 88.32% |
| Reference price | $3.39 |
The resulting weighted-average grant-date fair value of these awards was $4.80 per unit and a total grant-date fair value of $56.2 million. Compensation cost is recognized on a straight-line basis over the requisite service period regardless of whether the market condition is ultimately achieved, and is not reversed if the market condition is not met.
RSU Awards Summary
The following table summarizes our restricted stock unit award activity during thesix months ended June 30, 2026:
| Weighted | ||
|---|---|---|
| Number | Average | |
| of | Grant Date | |
| Shares | Fair Value | |
| Balance, December 31, 2025 | 1,084,330 | $3.76 |
| Granted | 13,507,235 | 4.25 |
| Cancelled/Forfeited | (112,500) | 3.63 |
| Balance, June 30, 2026 | 14,479,065 | $4.08 |
As of June 30, 2026, we had approximately $60.3 million in total unrecognized compensation expense related to our restricted stock unit awards that is to be recognized over a weighted-average period of approximately 3.28 years.
[d] Loss Per Share
For the six months ended June 30, 2026, a total of 93,688,388 shares, consisting of warrants to purchase 69,909,876 shares, options exercisable for 9,299,447 shares and 14,479,065 restricted stock units, have not been included in the loss per share computation, as their effect on diluted per share amounts would have been anti-dilutive. For the same period in 2025, a total of 39,004,028 shares underlying options, restricted stock units and warrants have not been included in the loss per share computation. Additionally, the outstanding New Convertible Term Loan is included in the calculation of diluted per share amounts only if its inclusion is dilutive for periods during which the notes were outstanding. As of June 30, 2026, the outstanding New Convertible Term Loan was not included in the calculation of diluted per share amounts as its effect would have been anti-dilutive.
[e] Non-employee options and restricted stock units
We recognize non-employee stock-based compensation expense over the period of expected service by the non-employee. As the service is performed, we are required to update our valuation assumptions, re-measure unvested options and restricted stock units and record the stock-based compensation using the valuation as of the vesting date. This differs from the accounting for employee awards where the fair value is determined at the grant date and is not subsequently adjusted. This re-measurement may result in higher or lower stock-based compensation expense in the Consolidated Statements of Loss and Comprehensive Loss. As such, changes in the market price of our stock could materially change the value of an option or restricted stock unit and the resulting stock-based compensation expense.
[f] Employee Share Purchase Plan
Our Board and stockholders approved the 2017 Employee Stock Purchase Plan, or ESPP, in August 2017. Contributions are made by eligible employees, subject to certain limits defined in the ESPP. The number of shares available for future purchases under the ESPP is 1,346,298 shares. All shares purchased under the ESPP are new share issuances.
For the three and six months ended June 30, 2026, we recorded a compensation expense of $41,000 and $81,000, respectively, related to the current ESPP offering period. For thethree and six months ended June 30, 2025, no compensation expense was recognized related to our ESPP as we did not have an active offering period.
During the six months ended June 30, 2026 40,518 shares were purchased under the ESPP. During thesix months ended June 30, 2025, no shares were purchased under the ESPP as we did not have an active offering period.
[g] Common Stock Warrants
The following is a summary of outstanding warrants to purchase common stock as of June 30, 2026:
| Total | |||
|---|---|---|---|
| Outstanding · Exercise | |||
| and · price per | |||
| Exercisable | Share | Expiration Date | |
| Pre-Funded warrants issued in August 2020 financing | 142,857 | $0.001 | * |
| Warrants issued in November 2022 financing | 4,093,141 | $4.500 | November 2029 |
| Warrants issued in June 2025 financing | 16,298,166 | $3.000 | June 2030 |
| Warrants issued in April 2026 financing | 49,518,569 | $3.510 | ** |
| Pre-Funded warrants issued in April 2026 financing | 100,500 | $0.001 | * |
*The pre-funded warrants do not have an expiration date.
**These warrants have an exercise price of $3.51 per common warrant share and are exercisable at any time after the date of issuance, subject to certain ownership limitations, and will expire on the later of the twentieth business day following (i) the date on which we publicly announce that the FDA has approved cytisinicline for smoking cessation in adults, or FDA Approval, and (ii) the date on which we notify the common warrant holders of the FDA Approval, provided that if a common warrant is not fully exercisable because we have insufficient authorized and unreserved shares of our common stock at the time of the public announcement of the FDA Approval, the common warrant will be exercisable for two years following the date on which we obtain stockholder approval for an amendment to our certificate of incorporation to increase the number of authorized shares of our common stock.
The agreements governing the above warrants include the following terms:
certain warrants have exercise prices which are subject to adjustment for certain events, including the issuance of stock dividends on our common stock and, in certain instances, the issuance of our common stock or instruments convertible into our common stock at a price per share less than the exercise price of the respective warrants (specifically those issued in the November 2022 financing);
warrant holders may exercise the warrants through a cashless exercise if, and only if, we do not have an effective registration statement then available for the issuance of the shares of our common stock. If an effective registration statement is available for the issuance of our common stock a holder may only exercise the warrants through a cash exercise;
the exercise price and the number and type of securities purchasable upon exercise of the warrants are subject to adjustment upon certain corporate events, including certain combinations, consolidations, liquidations, mergers, recapitalizations, reclassifications, reorganizations, stock dividends and stock splits, a sale of all or substantially all of our assets and certain other events;
in the case of certain warrants, in the event of an “extraordinary transaction” or a “fundamental transaction” (as such terms are defined in the respective warrant agreements), generally including any merger with or into another entity, sale of all or substantially all of the Company’s assets, tender offer or exchange offer, or reclassification of its common stock, in which the successor entity (as defined in the respective warrant agreements) that assumes the warrants is not a publicly traded company, the Company or any successor entity will pay the warrant holder, at such holder’s option, exercisable at any time concurrently with or within 30 days after the consummation of the extraordinary transaction or fundamental transaction, an amount of cash equal to the value of such holder’s warrants as determined in accordance with the Black Scholes option pricing model and the terms of the respective warrant agreement. In some circumstances, we or successor entity may be obligated to make such payments regardless of whether the successor entity that assumes the warrants is a publicly traded company; and
with respect to the warrants issued in the June 2025 financing, or the 2025 Warrants, in the event we consummate a “fundamental transaction,” as described in the 2025 Warrants and generally including a merger or consolidation with or into another entity or other reorganization event in which our common shares are converted or exchanged for securities, cash or other property, we are not the surviving entity and in which our stockholders immediately prior to the merger or consolidation do not own, directly or indirectly, at least 50%of the voting power of the surviving entity immediately after such merger or consolidation (excluding any merger effected solely to change the Company’s name), or we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets or another entity acquires 50% or more of our outstanding shares of common stock, then following such event, the holders of the 2025 Warrants will be entitled to receive upon exercise of such 2025 Warrants the same kind and amount of securities, cash or property which the holders would have received had they exercised their Warrants immediately prior to such fundamental transaction. Any successor to us or surviving entity shall assume the obligations under the 2025 Warrants. Additionally, as more fully described in the 2025 Warrants, in the event of certain fundamental transactions, the holders of the 2025 Warrants will be entitled to receive consideration in an amount equal to the Black Scholes value, as defined in the 2025 Warrants, on the date of consummation of such transaction.
During the three and six months ended June 30, 2026, no warrants were exercised and warrants to purchase 7,000 shares were exercised at a per share price of $3.00, for aggregate proceeds of $21,000, respectively. No warrants were exercised for thethree and six months ended June 30, 2025.
- RELATED PARTY TRANSACTIONS
From September 25, 2025 to December 22, 2025, we entered into three develop ment agreements, or the Adare Agreements, with Adare Pharma Solutions, or Adare, to perform analytical and drug product development for cytisinicline. Thomas Sellig is the current Chief Executive Officer of Adare. Thomas Sellig is also a member of our Board, chairs the Compensation Committee of the Board and is a member of the Audit Committee of the Board.
We expect to incur approximately $3.2 million in expenses over the term of the Adare Agreements. Adare will invoice us for work completed under the agreements based on industry standard payment terms and will be paid in cash. For thethree and six months ended June 30, 2026, we incurred expenses of $0.4 million and $0.7 million, respectively, related to the Adare Agreements. For the year ended December 31, 2025, we incurred expenses of $34,000 related to the Adare Agreements. As of June 30, 2026, we recorded a prepayment of $0.2 million and accrued clinical liabilities of $0.2 million on our balance sheet related to the Adare Agreements. As of December 31, 2025, we recorded a prepayment of $0.2 million on our balance sheet related to the Adare Agreements. Since entering into the agreements, we have incurred a total of $0.8 million in R&D expenses.
On November 10, 2025, we entered into a consulting agreement with Kristen Slaoui to provide strategic business development and transaction advisory support services. Dr. Slaoui was a member of our Board, the Compensation Committee of the Board and the Nominating and Corporate Governance Committee of the Board until July 2, 2026. We incurred consulting fees from Dr. Slaoui of $24,000 and $48,000 for thethree and six months ended June 30, 2026, and $13,750 for the year ended December 31, 2025. As of June 30, 2026, we recorded $21,000 in accrued liabilities on our balance sheet due to Dr. Slaoui. As of December 31, 2025, we recorded amounts payable to Dr. Slaoui of $8,250 in accounts payable and $5,500 in accrued liabilities on our balance sheet. Since entering into the agreement we have incurred a total of $62,000 in consulting fees. The consulting agreement was terminated effective July 3, 2026.
- COMMITMENTS AND CONTINGENCIES
The following table summarizes our contractual obligations as of June 30, 2026 (in thousands):
| Total | Less than 1 year | 1-3 years | 3-5 years | More than 5 years | |
|---|---|---|---|---|---|
| Vancouver office operating lease | $37 | $37 | $— | $— | $— |
| Total | $37 | $37 | $— | $— | $— |
Leases
We have operating leases for our corporate offices.
Operating leases with a term of 12 months or longer are included in ROU assets, other current liabilities, and operating lease liabilities on our consolidated balance sheets. Finance leases are included in property and equipment, other current liabilities, and other long-term liabilities on our consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use the incremental borrowing rate of comparable companies from a representative peer group selected based on industry and market capitalization. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
Vancouver lease arrangement
On November 19, 2018, we entered into a lease agreement, or the Vancouver Lease, for office space in Vancouver, British Columbia, which commenced on February 1, 2019, and had afour-year term. Pursuant to the terms of the Vancouver Lease, we rent approximately 2,367 square feet of office space. On December 16, 2022, we entered into an agreement toextend the Vancouver Lease for anothertwo-year term, which commenced on February 1, 2023. On December 9, 2024, we extended the Vancouver Lease for a furthertwo-year term, which commenced on February 1, 2025. Pursuant to this Vancouver Lease, we rent approximately 2,367 square feet of office space. The annual rent is approximately $0.1 million.
Consolidated rent expense relating to the Vancouver, British Columbia office, for the three and six months ended June 30, 2026, was $29,000 and $61,000, respectively, and, for thethree and six months ended June 30, 2025, was $30,000 and $61,000, respectively.
Other information related to leases was as follows (dollars in thousands):
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Supplemental Cash Flow Information | ||||
| Cash paid for amounts included in the measurement of lease liabilities: | ||||
| Operating cash flows to operating leases | $15 | $13 | $30 | $85 |
| Right-of-use assets obtained in exchange for lease obligations: | ||||
| Operating leases | — | — | — | — |
| Weighted Average Remaining Lease Term | ||||
| Operating leases | 0.58 years | 1.58 years | 0.58 years | 1.58 years |
| Weighted Average Discount Rate | ||||
| Operating leases | 8.98% | 8.98% | 8.98% | 8.98% |
Guarantees and Indemnifications
We indemnify our officers, directors and certain consultants for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at its request in such capacity. The term of the indemnification period is equal to the officer’s or director’s lifetime.
The maximum amount of potential future indemnification is unlimited; however, we have obtained director and officer insurance that limits our exposure and may enable us to recover a portion of any future amounts paid. We believe that the fair value of these indemnification obligations is minimal. Accordingly, we havenot recognized any liabilities relating to these obligations as of June 30, 2026.
We have certain agreements with certain organizations with which we do business that contain indemnification provisions pursuant to which we typically agree to indemnify the party against certain types of third-party claims. We accrue for known indemnification issues when a loss is probable and can be reasonably estimated. There wereno accruals for, or expenses related to, indemnification for any period presented.
- SUBSEQUENT EVENTS
Increase in authorized common stock
On July 2, 2026, our stockholders approved an amendment to our Certificate of Incorporation to increase the number of authorized shares of common stock from 150,000,000 shares to 300,000,000 shares. The amendment was filed with the Secretary of State of Delaware and became effective on July 6, 2026. This increase in authorized shares did not affect the number of shares issued and outstanding as of June 30, 2026.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.