ACHIEVE LIFE SCIENCES, INC.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
ACHV$6.72+5.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-104571
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-268074
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 83 previous paragraphs and 93 current paragraphs.
55 unchanged; 26 reworded; 10 added; 1 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
In October 2025, the FDA awarded cytisinicline for nicotine e-cigarette, or vaping, cessation the Commissioner’s National Priority Voucher, or CNPV, as part of the pilot program. The CNPV is granted to products with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization or addressing a public health crisis. CNPV recipients will receive a decision from the FDA within one to two months following filing of a complete application for a drug, as well as enhanced communication with review staff throughout the development process prior to their final submission and during the review period. Currently, there are no FDA-approved therapies indicated specifically as an aid for nicotine e-cigarette cessation.
Current report
Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our ability to obtain additional financing. For additional information, see the section titled “—Liquidity, Capital Resources and Going Concern.”
Current report
In October 2025, the FDA awarded cytisinicline for nicotine e-cigarette, or vaping, cessation the CNPV as part of the pilot program. The CNPV is granted to products with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization or addressing a public health crisis. CNPV recipients will receive a decision from the FDA within one to two months following filing of a complete application for a drug, as well as enhanced communication with review staff throughout the development process prior to their final submission and during the review period.
Current report
Liquidity, Capital Resources and Going Concern
Current report
The financial results have been prepared assuming we will continue to operate as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business.
Current report
Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our ability to obtain additional financing. While we have historically financed our operations through equity offerings, debt financings and government grants, the timing and amount of future financings may be impacted by macroeconomic conditions including uncertainty in the capital markets. There can be no assurance that financing from these or other sources will be available to us in the future. Without additional funds, we may be forced to delay, scale back or eliminate some of our commercialization and R&D activities or other operations and potentially delay product development in an effort to provide sufficient funds to continue our operations. If any of these events occur, our ability to achieve our commercialization and development goals would be adversely affected.
Current report
Our current resources are insufficient to fund our planned operations for the next 12 months. We will continue to require substantial additional capital to continue our commercialization and clinical development activities. Accordingly, we will need to raise substantial additional capital from the sale of our securities, debt, partnering arrangements, non-dilutive fundraising or other financing transactions in order to continue to fund our operations and finance the remaining development and commercialization of our product candidate. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of regulatory review, our commercialization efforts and our clinical development activities. The uncertainty with respect to our operations and the market generally may also make it challenging to raise additional capital on favorable terms, if at all. In addition, current macroeconomic conditions have caused uncertainty in various sectors, including the capital markets. Failure to raise capital as and when needed, on favorable terms or at all, will have a negative impact on our financial condition and our ability to prepare for commercialization and develop our product candidate.
Current report
In addition, we expect to incur significant expenses and increasing operating losses for at least the next several years as we continue our clinical development of, seek regulatory approval for, and commercialize, cytisinicline and add personnel necessary to operate as a commercial-stage public company. We expect that our operating losses will fluctuate significantly from quarter to quarter and year to year due to timing efforts to achieve regulatory approval, commercialization activities, and of clinical development programs.
Current report
The consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should we be unable to continue as a going concern. Such adjustments could be material.
Current report
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.
Removed paragraphs (1)
Previous report
Liquidity and Capital Resources
Reworded paragraphs (26)
Previous wording
While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain highly addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease. In 2024, 1.6 million high school and middle school students reported using e-cigarettes. Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never used e-cigarettes. In 2024, the FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. Breakthrough Therapy designation is a process that expedites the development and review of new drugs and biologics that are intended to treat serious or life-threatening conditions and have preliminary clinical evidence indicating substantial improvement over existing therapies. Currently, there are no FDA approved drug therapies indicated specifically as an aid to nicotine e-cigarette cessation. We believe cytisinicline represents a unique opportunity to significantly impact global health by addressing the considerable unmet need among millions of smokers and e-cigarettes users.
Current wording
While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain highly addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease. In 2024, 1.6 million high school and middle school students reported using e-cigarettes. Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never used e-cigarettes. In 2024, the FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. Breakthrough Therapy designation is a process that expedites the development and review of new drugs and biologics that are intended to treat serious or life-threatening conditions and have preliminary clinical evidence indicating substantial improvement over existing therapies.
Previous wording
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to work in treating nicotine dependence for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain by reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine dependence. In June 2025, we submitted an NDA to the FDA for cytisinicline as a treatment for smoking cessation as the first indication in the United States.
Current wording
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to work in treating nicotine dependence for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain by reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine dependence. In September 2025, we announced that the FDA accepted for review our NDA for cytisinicline as a treatment for smoking cessation as the first indication in the United States and assigned a Prescription Drug User Fee Act, or PDUFA, targeted action date of June 20, 2026.
Previous wording
We believe cytisinicline represents a unique opportunity to significantly impact global health by addressing the considerable unmet need among millions of smokers and e-cigarettes users. If approved by the FDA, it may become one of the first new prescription medicines in nearly two decades aimed at aiding individuals in overcoming nicotine dependence. We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile, and a shorter therapy duration, as demonstrated in clinical trials.
Current wording
We believe cytisinicline represents a unique opportunity to significantly impact global health by addressing the considerable unmet need among millions of smokers and e-cigarettes users. If approved by the FDA, it may become one of the first new prescription medicines in nearly two decades aimed at aiding individuals in overcoming nicotine dependence. We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile, and a potential option for a shorter therapy duration as compared to existing prescription smoking cessation therapies, as demonstrated in clinical trials.
Previous wording
We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have never been profitable and have incurred operating losses in each year since inception. Our net loss was $25.5 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $231.1 million, cash, cash equivalents and marketable securities balance of $55.4 million and a positive working capital balance of $48.3 million. For the six months ended June 30, 2025, net cash used in operating activities was $20.2 million.
Current wording
We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have never been profitable and have incurred operating losses in each year since inception. Our net loss was $40.0 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $245.6 million, cash, cash equivalents and marketable securities balance of $48.1 million and a positive working capital balance of $40.3 million. For the nine months ended September 30, 2025, net cash used in operating activities was $31.5 million.
Previous wording
In June 2025, we announced the submission of an NDA with the FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults. The cytisinicline NDA is supported by a combination of efficacy and well-tolerated safety results from two large, placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation. In both studies, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. We also included safety data on over 300 participants with at least six months of cumulative cytisinicline exposure from the open-label long-term trial, ORCA-OL, and the Data Safety Monitoring Committee did not identify new safety concerns in this trial.
Current wording
In September 2025, we announced that the FDA accepted for review our NDA for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults and assigned a PDUFA targeted action date of June 20, 2026. The cytisinicline NDA is supported by a combination of efficacy and safety results from two large, placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation, and an open label exposure trial, ORCA-OL, which evaluated long-term safety exposure of cytisinicline. In the ORCA-2 and ORCA-3 Phase 3 studies, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. Safety data from the ORCA-OL trial on over 300 patients with at least six months of cumulative cytisinicline exposure were included as part of our NDA submission and safety data on over 100 patients receiving at least one year of cumulative cytisinicline exposure were submitted to the FDA as part of a 120-day safety update. In November 2025, we announced completion of the fourth and final scheduled safety review by the Data Safety Monitoring Committee, or DMSC, for the ORCA-OL trial. Adverse events reviewed during the final DSMC meeting were mostly mild in severity, and no serious adverse events were deemed to be treatment related. The DSMC found no concerns with respect to drug safety.
Previous wording
In December 2024, we announced the completion of our end-of-Phase 2 meeting with the FDA to review and receive guidance on our proposed Phase 3 clinical program for a future supplemental NDA submission, or sNDA, to expand cytisinicline for vaping cessation treatment. We obtained FDA agreement on a proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting an sNDA. The FDA was in alignment on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of vaping abstinence with biochemical verification, and other overall study assessments. The FDA agreed that one well-controlled Phase 3 trial, in addition to our completed Phase 2 ORCA-V1 trial and the safety exposure data from our ongoing ORCA-OL trial, would be sufficient for a vaping cessation indication as an sNDA. Dependent on availability of funding, we intend to initiate Phase 3 clinical development of cytisinicline for nicotine dependence for e-cigarettes/vaping. We would target to enroll and complete study evaluations approximately 12 months after study initiation. We may explore additional indications for the treatment of nicotine dependence in the future.
Current wording
In December 2024, we announced the completion of our end-of-Phase 2 meeting with the FDA to review and receive guidance on our proposed Phase 3 clinical program for a future supplemental NDA submission, or sNDA, to expand cytisinicline for vaping cessation treatment. We obtained FDA agreement on a proposed single Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of vaping abstinence with biochemical verification, and other overall study assessments, as well as additional requirements for submitting an sNDA. The FDA agreed that one well-controlled Phase 3 trial, in addition to our completed Phase 2 ORCA-V1 trial and the safety exposure data from our ORCA-OL trial, would be sufficient for a vaping cessation indication as an sNDA. We would target to enroll and complete study evaluations approximately 12 months after study initiation. We may explore additional indications for the treatment of nicotine dependence in the future.
Previous wording
Ongoing Open Label ORCA-OL Trial
Current wording
Completed Open Label ORCA-OL Trial
Previous wording
The ORCA-OL open-label exposure trial was initiated in May 2024 and enrollment was completed in October 2024 with 479 subjects enrolled at 29 clinical trial sites across the United States. ORCA-OL is designed to evaluate the long-term safety exposure of 3 mg cytisinicline treatment dosed three times daily in U.S. adults who want to quit smoking or vaping. Subjects receive cytisinicline treatment and are monitored for safety events for up to one year. The primary endpoint is frequency of serious adverse events, or SAEs. Other safety and efficacy outcomes will be collected.
Current wording
The ORCA-OL open-label exposure trial was initiated in May 2024 and was completed in September 2025. The clinical trial enrolled 479 subjects at 29 clinical trial sites across the United States. ORCA-OL was designed to evaluate the long-term safety exposure of 3 mg cytisinicline treatment dosed three times daily in U.S. adults who want to quit smoking or vaping. Subjects received cytisinicline treatment and were monitored for safety events for up to one year. The primary endpoint was frequency of serious adverse events, or SAEs. Other safety and efficacy outcomes were also collected.
Previous wording
In April 2025, the ORCA-OL trial reached the second milestone, with at least 100 subjects completing one year of cumulative cytisinicline treatment. The cumulative one-year exposure data will be provided prior to potential product approval.
Current wording
In April 2025, the ORCA-OL trial reached the second milestone, with at least 100 subjects completing one year of cumulative cytisinicline treatment. The cumulative one-year exposure data were submitted to the FDA in October of 2025 as part of the 120-day safety update.
Previous wording
We recently 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 engage 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 and included third-party manufacturers. Sopharma has alleged that our engagement of third-party manufacturers is a breach of our agreement, which we have disputed and have proposed steps to resolve.
Current wording
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 engage 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 and included third-party manufacturers. Sopharma has alleged that our engagement of third-party manufacturers is a breach of our agreement, which we have disputed and have proposed steps to resolve.
Previous wording
On May 14, 2015, we entered into a Share Purchase Agreement with Sopharma to acquire 75% of the outstanding shares of Extab Corporation for $2.0 million in cash and $2.0 million in a deferred payment, contingent on regulatory approval of cytisinicline by the
Current wording
On May 14, 2015, we entered into a Share Purchase Agreement with Sopharma to acquire 75% of the outstanding shares of Extab Corporation 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, or EMA. 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,
Previous wording
As of June 30, 2025, the fair value of the contingent consideration was estimated to be $1.3 million (see Note 5 “Fair Value Measurements, Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying unaudited consolidated financial statements). We recognized a loss of $0.1 million and $0.2 million for the three and six months ended June 30, 2025, respectively.
Current wording
As of September 30, 2025, the fair value of the contingent consideration was estimated to be $1.4 million (see Note 5 “Fair Value Measurements, Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying unaudited consolidated financial statements). We recognized a loss of $0.1 million and $0.3 million for the three and nine months ended September 30, 2025, respectively.
Previous wording
For the three and six months ended June 30, 2025 and 2024
Current wording
For the three and nine months ended September 30, 2025 and 2024
Previous wording
Our R&D expenses are devoted to our one ongoing clinical development program, cytisinicline. R&D expenses for the three months ended June 30, 2025 increased to $6.7 million as compared to $5.1 million for the three months ended June 30, 2024. For the six months ended June 30, 2025, R&D expenses increased to $13.8 million from $7.9 million for the six months ended June 30, 2024. The increases in expenses for the three and six months ended June 30, 2025 were primarily due to costs from our ORCA-OL open-label safety trial, which continued at full enrollment during the three and the six months ended June 30, 2025, as compared to the same periods in 2024 during which costs incurred were associated with initiation and commencement of enrollment of our ORCA-OL trial, which initiated in the second quarter of 2024.
Current wording
Our R&D expenses are devoted to our one ongoing clinical development program, cytisinicline. R&D expenses for the three months ended September 30, 2025 decreased to $5.3 million as compared to $7.6 million for the three months ended September 30, 2024. For the nine months ended September 30, 2025, R&D expenses increased to $19.1 million from $15.5 million for the nine months ended September 30, 2024. The decrease in expense for the three months ended September 30, 2025 was primarily due to the wind down of the ORCA-OL trial, which was completed in September 2025, as compared to the same period in 2024, in which costs incurred were associated with ramp up of enrollment in the ORCA-OL trial, initiated in May 2024 and completed in October 2024. The increase in expense for the nine months ended September 30, 2025 was primarily due costs associated with the ORCA-OL trial, which continued at full enrollment during the nine months ended September 30, 2025, as compared to the same period in 2024 during which costs incurred were associated with initiation and commencement of enrollment of our ORCA-OL trial, which initiated in the second quarter of 2024.
Previous wording
General and administrative expenses for the three and six months ended June 30, 2025 increased to $5.9 million and $11.7 million, respectively, from $3.3 million and $6.5 million for the three and six months ended June 30, 2024, respectively. The increases in expenses for the three and six months ended June 30, 2025 as compared to the same periods in 2024, were primarily due to higher employee and commercial launch preparation costs. For the three and six months ended June 30, 2025 as compared to the same periods in 2024, employee expense increases included $1.1 million and $1.9 million, respectively, in higher stock-based compensation expense, and $0.3 million and $0.5 million, respectively, in non-stock based compensation expense related to headcount. Increases in commercial launch preparation costs for the three and six months ended June 30, 2025, as compared to the same periods in 2024, were $0.5 million and $1.7 million, respectively.
Current wording
General and administrative expenses for the three and nine months ended September 30, 2025 increased to $9.4 million and $21.0 million, respectively, from $4.9 million and $11.4 million for the three and nine months ended September 30, 2024, respectively. The increases in expenses for the three and nine months ended September 30, 2025 as compared to the same periods in 2024, were primarily due to higher commercial launch preparation and employee costs. For the three and nine months ended September 30, 2025 as compared to the same periods in 2024, employee expense increases included $0.1 million and $2.7 million, respectively, in higher stock-based compensation expense. This was partially offset by higher severance costs in 2024. For the three and nine months ended September 30, 2025 as compared to the same periods in 2024, increases in commercial launch preparation costs, were $4.3 million and $7.2 million, respectively.
Previous wording
Total interest income for the three and six months ended June 30, 2025, was $0.2 million and $0.5 million, respectively, compared to $0.8 million and $1.2 million for three and six months ended June 30, 2024, respectively. The decrease in interest income for the three and six months ended June 30, 2025, as compared to the same period in 2024 was primarily due to lower average cash balances throughout the first six months of 2025 and lower interest rates.
Current wording
Total interest income for the three and nine months ended September 30, 2025, was $0.6 million and $1.1 million, respectively, compared to $0.7 million and $1.9 million for three and nine months ended September 30, 2024, respectively. The decrease in interest income for the three and nine months ended September 30, 2025, as compared to the same period in 2024 was primarily due to lower average cash balances throughout the first nine months of 2025 and lower interest rates.
Previous wording
Total interest expense for the three and six months ended June 30, 2025, was $0.2 million and $0.4 million, respectively, compared to $0.8 million and $1.6 million for the three and six months ended June 30, 2024, respectively. The decrease in interest expense for the six months ended June 30, 2025 as compared to the same period in 2024 was due to a lower principal balance on our New Convertible Term Loan, relative to the Convertible Term Loan, that bears only a monthly interest as a result of the debt refinancing under the New Debt Agreement (see "Liquidity and Capital Resources" below).
Current wording
Total interest expense for the three and nine months ended September 30, 2025, was $0.2 million and $0.6 million, respectively, compared to $0.4 million and $2.0 million for the three and nine months ended September 30, 2024, respectively. The decrease in interest expense for the three and nine months ended September 30, 2025 as compared to the same periods in 2024 was due to a lower principal balance on our New Convertible Term Loan, relative to the Convertible Term Loan, that bears only a monthly interest as a result of the debt refinancing under the New Debt Agreement (see "Liquidity and Capital Resources" below).
Previous wording
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. 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 (see Note 5 “Fair Value Measurements, Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying consolidated financial statements).
Current wording
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. 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 (see Note 5 “Fair Value Measurements,
Previous wording
For the three and six months ended June 30, 2025, we recognized a loss of $ 0.1 million and $ 0.2 million, respectively. For the three and six months ended June 30, 2024, we recognized a loss of $0.1 million and $0.1 million, respectively.
Current wording
For the three and nine months ended September 30, 2025, we recognized a loss on the fair value of the contingent consideration of $ 0.1 million and $ 0.3 million, respectively. For the three and nine months ended September 30, 2024, we recognized a loss of $0.1 million and $0.2 million, respectively.
Previous wording
We have incurred an accumulated deficit of $231.1 million through June 30, 2025 and we expect to incur substantial additional losses in the future as we operate our business and continue or expand our regulatory, manufacturing, commercialization and other R&D activities and other operations. We have not generated any revenue from product sales to date, and we may not generate product sales revenue in the near future, if ever. As of June 30, 2025, we had a cash, cash equivalents and marketable securities balance of $55.4 million and a positive working capital balance of $48.3 million. For the six months ended June 30, 2025, net cash used in operations was $20.2 million.
Current wording
We have incurred an accumulated deficit of $245.6 million through September 30, 2025 and we expect to incur substantial additional losses in the future as we operate our business and continue or expand our regulatory, manufacturing, commercialization and other R&D activities and other operations. We have not generated any revenue from product sales to date, and we may not generate product sales revenue in the near future, if ever. As of September 30, 2025, we had a cash, cash equivalents and marketable securities balance of $48.1 million and a positive working capital balance of $40.3 million. For the nine months ended September 30, 2025, net cash used in operations was $31.5 million.
Previous wording
We have historically financed our operations through equity and 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 other sources, which may include licensing, collaborations or other strategic transactions or arrangements) to support the ongoing clinical development and commercialization activities. We believe that our existing cash, cash equivalents and marketable securities will be sufficient for us to fund our current operating expenses and capital expenditures into the second half of 2026.
Current wording
We have historically financed our operations through equity and debt financings and government grants. 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 other sources, which may include licensing, collaborations or other strategic transactions or arrangements) to support the ongoing clinical development and commercialization activities. We believe that our existing cash, cash equivalents and marketable securities will be sufficient for us to fund our current operating expenses and capital expenditures into the second half of 2026.
Previous wording
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 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 filing for cytisinicline by the FDA in a Day 74 Letter or equivalent correspondence. 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.
Current wording
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 were immediately exercisable for shares of common stock or pre-funded warrants in lieu thereof and expired in October 2025 on the date 30 days after our public disclosure of the acceptance of an NDA filing 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.
Previous wording
On September 27, 2024, we entered into an Open Market Sale Agreement, or Sale Agreement, with Jefferies LLC as sales agent, to establish an at-the-market offering program through which we may sell shares of our common stock with an aggregate offering price of up to $50.0 million. During the three and six months ended June 30, 2025, we did not sell any shares under the Sale Agreement. As of June 30, 2025, we had $50.0 million available under the Sale Agreement.
Current wording
On September 27, 2024, we entered into an Open Market Sale Agreement, or Sale Agreement, with Jefferies LLC as sales agent, to establish an at-the-market offering program through which we may sell shares of our common stock with an aggregate offering price of up to $50.0 million. On November 6, 2025, the Sale Agreement with Jeffries LLC was terminated and no sales of our common stock will be made pursuant to the Sale Agreement.
Previous wording
For the six months ended June 30, 2025, net cash used in operating activities was $20.2 million compared to $10.2 million for the six months ended June 30, 2024. The increase in cash used in operations in the 2025 period as compared to the 2024 period was due to higher R&D expenses associated with our ORCA-OL open-label safety trial, which was initiated in May 2024 and continued at full enrollment during the six months ended June 30, 2025.
Current wording
For the nine months ended September 30, 2025, net cash used in operating activities was $31.5 million compared to $20.6 million for the nine months ended September 30, 2024. The increase in cash used in operations in the 2025 period as compared to the 2024 period was due to higher R&D expenses associated with our ORCA-OL open-label safety trial, which was initiated in May 2024 and continued at full enrollment during the nine months ended September 30, 2025.
Previous wording
For the six months ended June 30, 2025, net cash provided by financing activities was $41.2 million, compared to $56.0 million for the six months ended June 30, 2024. Net cash provided by financing activities in the six months ended June 30, 2025 related to proceeds received from the June 2025 public offering. Net cash provided by financing in the six months ended June 30, 2024, related to proceeds received from the February 2024 registered direct offering.
Current wording
For the nine months ended September 30, 2025, net cash provided by financing activities was $45.3 million, compared to $47.8 million for the nine months ended September 30, 2024. Net cash provided by financing activities in the nine months ended September 30, 2025 related to proceeds received from the June 2025 public offering and from warrant exercises. Net cash provided by financing in the nine months ended September 30, 2024, related to proceeds received from the February 2024 registered direct offering, the New Convertible Term Loan associated with the refinancing transaction, and stock sales under our employee stock purchase plan.
Previous wording
For the six months ended June 30, 2025, net cash provided by investing activities was $18.1 million compared to $46.6 million used in investing activities for the six months ended June 30, 2024. Net cash used and provided by investing activities in the six months ended June 30, 2025 and 2024, respectively, was due to transactions involving marketable securities in the normal course of business.
Current wording
For the nine months ended September 30, 2025, net cash provided by investing activities was $5.4 million compared to $33.3 million used in investing activities for the nine months ended September 30, 2024. Net cash used and provided by investing activities in the nine months ended September 30, 2025 and 2024, respectively, was due to transactions involving marketable securities in the normal course of business.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying consolidated financial statements).
Current report — wording carried from elsewhere
During the three and nine months ended September 30, 2025, we did not sell any shares under the Sale Agreement. As of September 30, 2025, we had $50.0 million available under the Sale Agreement.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
FDA or the European Medicines Agency, or EMA. 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,