ACHIEVE LIFE SCIENCES, INC.

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 are associated with lung injury, cardiovascular disease and cancer. In 2025, 1.4 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 U.S. Food and Drug Administration, or 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.

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 are associated with lung injury, cardiovascular disease and cancer. In 2025, 1.4 million high school and middle school students reported using e-cigarettes. In 2024, the U.S. Food and Drug Administration, or 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

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. A CNPV is granted to product candidates 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 wording

In October 2025, the FDA awarded cytisinicline for vaping cessation the Commissioner’s National Priority Voucher, or CNPV, as part of the pilot program. A CNPV is granted to product candidates 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.

Previous wording

Cytisinicline is a naturally occurring 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 craving and 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 New Drug Application, or 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.

Current wording

Cytisinicline is an investigational compound that binds to nicotinic receptors. It is being developed as an aid to smoking cessation treatment in adults and as an aid to vaping cessation. It is believed to work in treating nicotine dependence by interacting with nicotinic receptors in the brain by reducing the severity of craving and withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products.

Previous wording

In June 2026, we received a Complete Response Letter, or CRL, from the FDA regarding our NDA for cytisinicline relating to outstanding manufacturing-related observations from a current Good Manufacturing Practice, or cGMP, inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline. The deficiencies cited in the CRL concern our prior third-party manufacturer named in our NDA, who underwent a non-Achieve related FDA cGMP inspection and the FDA made observations, two of which were related to solid oral dose manufacturing. As a result, the third-party manufacturer's facility, where the FDA made the two observations, received an Official Action Indicated, or OAI, classification and a warning letter. The observations resulting in the OAI classification and warning letter at the third-party manufacturer's facility relate to general cGMP matters at the facility and are not specific to cytisinicline. We have partnered with a U.S.-based manufacturer, Adare Pharma Solutions, or Adare, to manufacture our finished drug product for potential commercial launch and beyond (see Note 8 "Related Party Transactions" in the accompanying consolidated financial statements). We have completed the analytical method transfer to Adare's manufacturing facility in Vandalia, Ohio. In addition, we have completed our first cytisinicline engineering batch manufactured at Adare's facility and fully qualified all testing procedures at the site. We anticipate the partnership with Adare will help to decrease risks related to our supply chain and international importation of pharmaceuticals, and reduce costs, including with respect to potential tariffs. We intend to resubmit the NDA naming Adare as our finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipate the potential approval of cytisinicline for smoking cessation in the first half of 2027, followed by U.S. commercial launch.

Current wording

In June 2026, we received a Complete Response Letter, or CRL, from the FDA regarding our NDA for cytisinicline relating to outstanding manufacturing-related observations from a current Good Manufacturing Practice, or cGMP, inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline. The deficiencies cited in the CRL concern our prior third-party manufacturer named in our NDA, which underwent a non-Achieve related FDA cGMP inspection in which the FDA made observations, two of which were related to solid oral dose manufacturing. As a result, the third-party manufacturer's facility, where the FDA made the two observations, received an Official Action Indicated, or OAI, classification and a warning letter. The observations resulting in the OAI classification and warning letter at the third-party manufacturer's facility relate to general cGMP matters at the facility and are not specific to cytisinicline. We have partnered with a U.S.-based manufacturer, Adare Pharma Solutions, or Adare, to manufacture our finished drug product for potential commercial launch and beyond (see Note 8 "Related Party Transactions" in the accompanying consolidated financial statements). We have completed the manufacture of three commercial-scale stability batches at Adare's facility and fully qualified all testing procedures at the site. We anticipate the partnership with Adare will help to decrease risks related to our supply chain and international importation of pharmaceuticals, and reduce costs, including with respect to potential tariffs. We intend to resubmit the NDA naming Adare as our finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipate the potential approval of cytisinicline for smoking cessation by the end of the second quarter of 2027, followed by U.S. commercial launch.

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-cigarette users. We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile and dosing flexibility with a 6 or 12-week regimen, 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 vaping users. We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile and dosing flexibility with a 6- or 12-week regimen, as demonstrated in clinical trials.

Previous wording

We believe we will be able to commercialize independently in the U.S. market by focusing our commercial efforts on areas where patient unmet needs are highest, while developing a framework to support broader adoption across payers, prescribers, and health systems. We are conducting market research to inform and validate our go-to-market strategy. This work coincides with building out internal commercial infrastructure. Commercial leadership activities are underway, with recruitment across key functional areas including market access, medical education, patient advocacy and government affairs, trade, and customer strategy. Additionally, we are evaluating the use of field-based representatives to supplement digital promotional efforts.

Current wording

We believe we will be able to commercialize independently in the U.S. market by focusing our commercial efforts on areas where patient unmet needs are highest, while developing a framework to support broader adoption across payers, prescribers, and health systems. We are conducting market research to inform and validate our go-to-market strategy. This work coincides with building out internal commercial infrastructure. Our commercial leadership team is in place, and additional recruitment is underway across our commercial organization, including our market access, sales and enablement, and commercial operations functions. Additionally, we have evaluated the use of field-based representatives and are evaluating sales force sizing.

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 $84.9 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $345.2 million, cash, cash equivalents and marketable securities balance of $187.3 million and a negative working capital balance of $9.4 million. For the six months ended June 30, 2026, net cash used in operating activities was $17.7 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 $97.0 million for the nine months ended September 30, 2026. As of September 30, 2026, we had an accumulated deficit of $357.3 million, cash, cash equivalents and marketable securities balance of $201.5 million and a positive working capital balance of $184.0 million. For the nine months ended September 30, 2026, net cash used in operating activities was $26.1 million.

Previous 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 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. We dispute these claims and intend to defend the matter vigorously. For more information on this arbitration demand, see “Item 1. Legal Proceedings."

Current wording

We communicated to Sopharma that we had concerns regarding its 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. We dispute these claims and intend to defend the matter vigorously. For more information on this arbitration demand, see “Part II, Item 1. Legal Proceedings."

Previous wording

As of June 30, 2026, 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 a gain of $0.2 million for the three 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.

Current wording

As of September 30, 2026, 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 $35,000 and a gain of $0.2 million for the three and nine months ended September 30, 2026, respectively, and a loss of $0.1 million and $0.3 million for the three and nine months ended September 30, 2025, respectively.

Previous wording

Research and development, or R&D, expenses consist primarily of costs for clinical trials, manufacture of product, personnel costs, milestone payments to third parties, facilities, regulatory activities, non-clinical studies and allocations of other R&D-related costs. External expenses for clinical trials include fees paid to clinical research organizations, clinical trial site costs and patient treatment costs.

Current wording

Research and development, or R&D, expenses consist primarily of costs for clinical trials, manufacturing of product, personnel costs, milestone payments to third parties, facilities, regulatory activities, non-clinical studies and allocations of other R&D-related costs. External expenses for clinical trials include fees paid to clinical research organizations, clinical trial site costs and patient treatment costs.

Previous wording

General and administrative expenses consist primarily of personnel costs related to executive, finance and accounting, commercial and other administrative functions, as well as consulting costs, including commercial, corporate communications, market research, business consulting, human resources and intellectual property. Other costs include professional fees for legal and auditing services, insurance and facility costs.

Current wording

General and administrative, or G&A, expenses consist primarily of personnel costs related to executive, finance and accounting, commercial and other administrative functions, as well as consulting costs, including commercial, corporate communications, market research, business consulting, human resources and intellectual property. Other costs include professional fees for legal and auditing services, insurance and facility costs.

Previous wording

For the three and six months ended June 30, 2026 and 2025

Current wording

For the three and nine months ended September 30, 2026 and 2025

Previous wording

Our R&D expenses are devoted to our one ongoing clinical development program, cytisinicline. R&D expenses for the three and six months ended June 30, 2026 decreased to $3.8 million and $7.1 million, respectively, as compared to $6.7 million and $13.8 million, respectively, for the three and six months ended June 30, 2025. The decrease in R&D expense was primarily due to a decrease in clinical trial costs of $3.2 million and $6.4 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025, which were associated with the ORCA-OL trial, which was completed in September 2025. In addition, R&D expenses were lower due to a decrease in stock-based compensation expense of $0.3 million and $1.3 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025, due to the revaluation of the probability of achieving certain performance conditions of our outstanding performance-based restricted stock unit awards. This was partially offset by higher manufacturing and supply chain costs of $0.4 million and $1.0 million during the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025, which were associated with commercial launch preparation, including purchase of raw cytisinicline inventory expensed to R&D prior to regulatory approval, completion of analytical method transfer to Adare and completion of an engineering batch manufactured at Adare's facility.

Current wording

The decrease in R&D expense for the nine months ended September 30, 2026, was primarily due to a decrease in clinical trial costs of $8.3 million as compared to the same period in 2025, which were associated with the ORCA-OL trial, which was completed in October 2025. In addition, R&D expenses were lower due to a decrease in stock-based compensation expense of $1.9 million as compared to the same period in 2025, due to the revaluation of the probability of achieving certain performance conditions of our outstanding performance-based restricted stock unit awards. This was partially offset by an increase in manufacturing and supply chain costs of $2.9 million during the nine months ended September 30, 2026, as compared to the same period in 2025, which were associated with manufacturing development, including purchase of raw cytisinicline inventory expensed to R&D prior to regulatory approval, completion of analytical method transfer to Adare, completion of an engineering batch manufactured at Adare's facility and continued progression of transition of finished drug product manufacturing to Adare, including packaging and stability. Additionally, higher employee expenses of $1.6 million as compared to the same period in 2025, due to severance, increased headcount and recruitment activity also offset the decrease in R&D expenses for the nine months ended September 30, 2026.

Previous wording

General and administrative expenses for the three and six months ended June 30, 2026 increased to $14.6 million and $21.8 million, respectively, from $5.9 million and $11.7 million, respectively, for the three and six months ended June 30, 2025. The increase in expenses was primarily due to an increase in commercial launch preparation costs of $0.4 million and $2.6 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025 and higher employee expenses of $7.7 million and $6.2 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025, which were associated with increased stock-based compensation and severance expenses.

Current wording

Our G&A expenses for the three and nine months ended September 30, 2026 increased to $14.3 million and $36.1 million, respectively, from $9.4 million and $21.0 million, respectively, for the three and nine months ended September 30, 2025. The increase in expenses was primarily due to an increase in stock-based compensation expense of $5.9 million and $8.4 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in 2025 and higher employee expenses of $1.3 million and $4.8 million for the three and nine months ended September 30, 2026, respectively, as compared to the same periods in

Previous wording

Total interest income for the three and six months ended June 30, 2026 was $1.5 million and $1.8 million, respectively, compared to $0.2 million and $0.5 million, respectively, for the three and six months ended June 30, 2025. The increase in interest income for the three and six months ended June 30, 2026, as compared to the same periods in 2025 was primarily due to higher average cash balances in the second quarter of 2026 from receipt of net proceeds from our April 2026 Private Placement financing.

Current wording

Total interest income for the three and nine months ended September 30, 2026 was $1.8 million and $3.6 million, respectively, compared to $0.6 million and $1.1 million, respectively, for the three and nine months ended September 30, 2025. The increase in interest income for the three and nine months ended September 30, 2026, as compared to the same periods in 2025 was primarily due to higher average cash balances in the second and third quarters of 2026 from receipt of net proceeds from our April 2026 Private Placement financing.

Previous wording

Total interest expense for the three and six months ended June 30, 2026, was $0.3 million and $0.6 million, respectively, compared to $0.2 million and $0.4 million for the three and six months ended June 30, 2025, respectively. The increase in interest expense for the three and six months ended June 30, 2026 as compared to the same periods in 2025 was due to a higher average debt balance of $15.0 million in 2026 as compared to $10.0 million in 2025.

Current wording

Total interest expense for the three and nine months ended September 30, 2026, was $0.3 million and $0.8 million, respectively, compared to $0.2 million and $0.6 million for the three and nine months ended September 30, 2025, respectively. The increase in interest expense for the three and nine months ended September 30, 2026 as compared to the same periods in 2025 was due to a higher average debt balance of $14.6 million in 2026 as compared to $10.0 million in 2025.

Previous wording

For the three and six months ended June 30, 2026, we recognized a loss of $0.1 million and a gain of $0.2 million, respectively, on the fair value of the contingent consideration. For the three and six months ended June 30, 2025, we recognized a loss on the fair value of the contingent consideration of $0.1 million and $0.2 million, respectively.

Current wording

For the three and nine months ended September 30, 2026, we recognized a loss of $35,000 and a gain of $0.2 million, respectively, on the fair value of the contingent consideration. 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.

Previous wording

We determine the fair value of the warrant liability using the Black-Scholes pricing model. Adjustments to the fair value of the warrant liability 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 Liability Classified Warrants” in the accompanying consolidated financial statements).

Current wording

We determined the fair value of the warrant liability using the Black-Scholes pricing model. Adjustments to the fair value of the warrant liability 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 Liability Classified Warrants and Pre-Funded Warrants” in the accompanying consolidated financial statements).

Previous wording

We recorded a loss of $48.5 million for the three and six months ended June 30, 2026. We did not have any warrants classified as a liability in 2025.

Current wording

For the three and nine months ended September 30, 2026, we recognized a gain of $6.9 million and a loss of $41.6 million, respectively. We did not have any warrants classified as a liability in 2025. On July 2, 2026, following stockholder approval of an increase in our authorized shares of common stock, the warrants were reclassified to equity and are no longer reassessed for their fair values at each reporting date.

Previous wording

We determine the fair value of the pre-funded warrant liability to approximate the underlying equity share.

Current wording

We determined the fair value of the pre-funded warrant liability to approximate the value of the underlying common stock.

Previous wording

We recorded a loss of $0.1 million for the three and six months ended June 30, 2026. We did not have any pre-funded warrants classified as a liability in 2025.

Current wording

For the three and nine months ended September 30, 2026, we recognized a gain of $13,000 and a loss of $0.1 million, respectively. We did not have any pre-funded warrants classified as a liability in 2025. On July 2, 2026, following stockholder approval of an increase in our authorized shares of common stock, the pre-funded warrants were reclassified to equity and are no longer reassessed for their fair values at each reporting date.

Previous wording

We have incurred an accumulated deficit of $345.2 million through June 30, 2026, 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, 2026, we had a cash, cash equivalents and marketable securities balance of $187.3 million and a negative working capital balance of $9.4 million. For the six months ended June 30, 2026, net cash used in operations was $17.7 million.

Current wording

We have incurred an accumulated deficit of $357.3 million through September 30, 2026, 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, 2026, we had a cash, cash equivalents and marketable securities balance of $201.5 million and a positive working capital balance of $184.0 million. For the nine months ended September 30, 2026, net cash used in operations was $26.1 million.

Previous wording

We have historically financed our operations through equity offerings, 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. 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 fund our operations and finance the remaining development and commercialization of our product candidate.

Current wording

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 fund our operations and finance the remaining development and commercialization of our product candidate.

Previous wording

We did not have during the periods presented, and we do not currently have, any commitments or obligations, including contingent obligations, other than the Sopharma Contingent Consideration (as defined in Note 4 "License Agreements" in the accompanying consolidated financial statements), arising from arrangements with unconsolidated entities or persons that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.

Current wording

We did not have during the periods presented, and we do not currently have, any commitments or obligations, including contingent obligations, other than the Sopharma contingent consideration (as described in Note 4 "License Agreements" in the accompanying consolidated financial statements), arising from arrangements with unconsolidated entities or persons that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.

Previous wording

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 of any prepayment pursuant to the New Debt Agreement, or (z) the maturity date. The New Convertible Term Loan was “interest-only” through June 30, 2026 (see Note 6 "Convertible Debt" in the accompanying consolidated financial statements).

Current wording

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 of any prepayment pursuant to the New Debt Agreement, or (z) the maturity date. The New Convertible Term Loan was “interest-only” through June 30, 2026. During the three months ended September 30, 2026, we made principal repayments of $1.9 million, and $13.1 million of principal remained outstanding as of September 30, 2026 (see Note 6 "Convertible Debt" in the accompanying consolidated financial statements).

Previous wording

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.

Current wording

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

Previous wording

We received net proceeds of approximately $168.2 million after deducting estimated placement agent fees and other expenses of approximately $11.8 million.

Current wording

We received net proceeds of approximately $168.2 million after deducting placement agent fees and other expenses of approximately $11.8 million.

Previous wording

For the six months ended June 30, 2026, net cash used in operating activities was $17.7 million compared to $20.2 million for the six months ended June 30, 2025. The decrease in cash used in operations in the 2026 period as compared to the 2025 period was due mainly to higher compensation costs paid out in 2025 for the 2024 bonuses associated with achievement of corporate goals and cash upfront payments in 2025 for commercial launch preparation activities. This was partially offset by payment of severance in 2026.

Current wording

For the nine months ended September 30, 2026, net cash used in operating activities was $26.1 million compared to $31.5 million for the nine months ended September 30, 2025. The decrease in cash used in operations in the 2026 period as compared to the 2025 period was due mainly to higher compensation costs paid out in 2025 for the 2024 bonuses associated with achievement of corporate goals and cash upfront payments in 2025 for commercial launch preparation activities. This was partially offset by payment of severance in 2026.

Previous wording

For the six months ended June 30, 2026, net cash provided by financing activities was $168.5 million, compared to $41.2 million for the six months ended June 30, 2025. Net cash provided by financing activities in the six months ended June 30, 2026 related to proceeds received from the April 2026 private placement, proceeds from the sale of shares under the ESPP plan, proceeds from the exercise of stock options and proceeds from the exercise of warrants. Net cash provided by financing activities in the six months ended June 30, 2025, related to proceeds received from the June 2025 public offering.

Current wording

For the nine months ended September 30, 2026, net cash provided by financing activities was $190.1 million, compared to $45.3 million for the nine months ended September 30, 2025. Net cash provided by financing activities in the nine months ended September 30, 2026 related to proceeds received from the April 2026 private placement, proceeds from the exercise of warrants, proceeds from the exercise of stock options and proceeds from the sale of shares under the ESPP plan. This was partially offset by principal repayments on our New Convertible Term Loan. 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 proceeds received from the exercise of warrants.

Previous wording

For the six months ended June 30, 2026, net cash used in investing activities was $123.5 million, compared to net cash provided by investing activities of $18.1 million for the six months ended June 30, 2025. Net cash used in investing activities for the six months ended June 30, 2026 and net cash provided by investing activities for the six months ended June 30, 2025, were due to transactions involving marketable securities in the normal course of business.

Current wording

For the nine months ended September 30, 2026, net cash used in investing activities was $125.2 million, compared to net cash provided by investing activities of $5.4 million for the nine months ended September 30, 2025. Net cash used in investing activities for the nine months ended September 30, 2026 and net cash provided by investing activities for the nine months ended September 30, 2025, were due to transactions involving marketable securities in the normal course of business.

Previous wording

We previously disclosed certain contractual obligations and contingencies and commitments relevant to us within the financial statements and Management’s Discussion and Analysis of Results of Operations and Liquidity and Capital Resources in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 24, 2026. For more information regarding our current contingencies and commitments, see Note 9 to the financial statements included above.

Current wording

We previously disclosed certain contractual obligations and contingencies and commitments relevant to us within the financial statements and Management’s Discussion and Analysis of Results of Operations and Liquidity and Capital Resources in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 24, 2026. For more information regarding our current contingencies and commitments, see Note 4 and Note 9 to the financial statements and to Part II, Item 1 included below.

Previous wording

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those estimates that we believe are critical and require the use of complex judgment in their application in our audited financial statements for the year ended December 31, 2025 in our Annual Report on Form 10-K filed with the SEC, on March 24, 2026. See Note 2, “Accounting Policies,” for new significant accounting polices since December 31, 2025.

Current wording

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those estimates that we believe are critical and require the use of complex judgment in their application in our audited financial statements for the year ended December 31, 2025 in our Annual Report on Form 10-K filed with the SEC, on March 24, 2026. See Note 2, “Accounting Policies,” for new significant accounting policies since December 31, 2025.