ACHV

General and Administrative Expenses General and administrative expenses consist primarily of personnel costs related to executive, finance and accounting, and other administrative functions, as well as consulting costs, including commercial, corporate communications, market research, business consulting, human resources and intellectual property.
Results of Operations Years Ended December 31, 2025 and 2024 Research and Development Expenses Our R&D expenses are devoted to our ongoing clinical development program, cytisinicline.
R&D expenses for the years ended December 31, 2025 and 2024 were $23.0 million and $22.8 million, respectively.
The increase in 2025 as compared to 2024 was primarily due to higher employee costs from increased headcount and higher manufacturing and supply chain costs associated with commercial launch preparation, including purchase of raw cytisinicline inventory expensed to R&D prior to regulatory approval.
This was partially offset by lower clinical trial costs associated with the wind down of the ORCA-OL trial which was completed at the end of September 2025.
General and Administrative Expenses General and administrative expenses for the years ended December 31, 2025 and 2024 were $31.9 million and $16.3 million, respectively.
The increase in 2025 as compared to 2024 was primarily due to higher commercial launch preparation costs, which were $12.3 million in 2025 as compared to $1.2 million in 2024, and a $2.7 million increase in stock-based compensation expense in 2025 as compared to 2024.
Interest Income Total interest income for the years ended December 31, 2025 and 2024 was $1.5 million and $2.4 million, respectively.
The decrease in interest income for the year ended December 31, 2025 as compared to 2024 was primarily due to lower average cash balances throughout 2025 and lower interest rates.
Interest Expense Total interest expense for the years ended December 31, 2025 and 2024 was $0.8 million and $2.2 million, respectively.
The decrease in interest expense for the year ended December 31, 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 prior contingent convertible debt agreement with the Lenders, that bears only a monthly interest as a result of the debt refinancing under the New Debt Agreement (such terms as defined in "Liquidity and Capital Resources" below).
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 6 “Fair Value Measurements—Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying consolidated financial statements).
For the years ended December 31, 2025 and 2024 we recognized losses of $0.4 million and $0.6 million, respectively.
Loss on extinguishment of 2023 Silicon Valley Bank convertible term loan The debt refinancing under the New Debt Agreement was recognized as an extinguishment of debt under Accounting Standards Update, or ASU, 470-50.
Liquidity, Capital Resources and Going Concern We have incurred an accumulated deficit of $260.2 million through December 31, 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.
As of December 31, 2025, we had cash, cash equivalents and marketable securities of $ 36.4 million and a positive working capital balance of $ 30.8 million.
For the year ended December 31, 2025, net cash used in operations was $49.5 million.
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.
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.
Without additional funds, we would be forced to delay, scale back or eliminate some of our commercialization and research and development, or 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 occurs, our ability to achieve our commercialization and development goals would be adversely affected.
The amount and timing of our future funding requirements will depend on many factors, including the pace of our commercialization activities and the pace and results of our clinical development efforts.
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.
We expect our expenses to substantially increase over time in connection with our development, particularly as we prepare our commercialization activities and advance our product candidate in clinical development.
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.
The New Convertible Term Loan matures on June 1, 2028 .
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.
The New Convertible Term Loan will be “interest-only” until 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 a conversion 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.
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.
As of December 31, 2025, we are in compliance with all covenants under the New Debt Agreement.
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.
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.

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Gone since FY2024

General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for our personnel in executive, finance and accounting, and other administrative functions, as well as consulting costs, including commercial, corporate communications, market research, business consulting, human resources and intellectual property.
Results of Operations Years Ended December 31, 2024 and 2023 Research and Development Expenses Our research and development expenses for our cytisinicline clinical development program are as follows (in thousands): Year Ended December 31, 2024 2023 Clinical development program: Cytisinicline $ 22,817 $ 15,814 Total research and development expenses $ 22,817 $ 15,814 Research and development expenses for the years ended December 31, 2024 and 2023 were $22.8 million and $15.8 million, respectively.
The increase in 2024 as compared to 2023 was primarily due to the initiation, in May 2024, of our ORCA-OL open label safety trial.
This increase was partially offset by a reduction in costs associated with our Phase 3 ORCA-3 trial and Phase 2 ORCA-V1 trial as both were completed in the second quarter of 2023.
General and Administrative Expenses Our general and administrative expenses were as follows (in thousands): Year Ended December 31, 2024 2023 Total general and administrative expenses $ 16,252 $ 11,436 G&A expenses for the years ended December 31, 2024 and 2023 were $16.3 million and $11.4 million, respectively.
The increase in 2024 as compared to 2023 was primarily due to higher employee expenses associated with stock based compensation expense and severance costs, commercial launch preparation costs, consulting costs, and legal expenses associated with patent activities and general corporate activities.
Interest Income Total interest income for the years ended December 31, 2024 and 2023 was $2.4 million and $0.8 million, respectively.
The increase in interest income for the year ended December 31, 2024 as compared to the same period in 2023was primarily due to higher average cash balances throughout 2024 and higher interest rates.
Interest Expense Total interest expense for the years ended December 31, 2024 and 2023 was $2.2 million and $2.9 million, respectively.
The decrease in interest expense for the year ended December 31, 2024 as compared to the same period in 2023 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).
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 7 “Fair Value Measurements, Fair Value of Sopharma Share Purchase Agreement Contingent Consideration” in the accompanying consolidated Financial Statements).
For the years ended December 31, 2024 and 2023 we recognized losses of $0.6 million and $0.5 million, respectively.
Loss on extinguishment of 2023 SVB convertible term loan The debt refinancing under the New Debt Agreement was recognized as an extinguishment of debt under Accounting Standards Update, or ASU, 470-50.
Liquidity, Capital Resources and Going Concern We have incurred an accumulated deficit of $205.6 million through December 31, 2024 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.
As of December 31, 2024, we had a cash, cash equivalents and marketable securities balance of $34.4 million and a positive working capital balance of $29.8 million.
For the year ended December 31, 2024, net cash used in operations was $29.8 million.
We have historically financed our operations through equity and debt financings.
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 advancement of our clinical trials and corporate 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 third quarter of 2025.
We have historically financed our operations through equity offerings and/or debt financings.
Without additional funds, we may be forced to delay, scale back or eliminate some of our research and development 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 development and commercialization goals would be adversely affected.
The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development, regulatory review and commercialization efforts.
In addition, current macroeconomic conditions have caused uncertainty in various sectors, including 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 develop our product candidate.
We expect that our operating losses will fluctuate significantly from quarter to quarter and year to year due to timing of clinical development programs and efforts to achieve regulatory approval and commercialization.
The New Convertible Term Loan matures on December 1, 2027, which maturity date may be extended to June 1, 2028 upon the occurrence of certain events as provided for in the New Debt Agreement.
The Lender will further make available to us, upon our request: (a) on or 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 receive written notice that the FDA has 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.
The New Convertible Term Loan will be “interest-only” until December 31, 2025, subject to extension as provided for in the New Debt Agreement.
The “interest-only” period may be extended to June 30, 2026, if (i) prior to December 31, 2025, we have received at least $ 40,000,000 in net cash proceeds from the issuance equity interests and (ii) the conditions of Additional Term Loan Event I have been satisfied.
Subject to certain terms and conditions, the conversion feature grants the Lender or, pursuant to an assignment, any designee thereof, or Conversion Right Holders, (as defined in the New Debt Agreement), 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 and third tranches of the New Convertible Term Loan, plus accrued and unpaid interest, into shares of our common stock at a conversion 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.
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 and third tranches 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.
Virtu At-the-Market Sales Agreement On December 21, 2021, we entered into an At-the-Market Offering Sales Agreement, or ATM, with Virtu Americas, LLC, as sales agent.
The ATM was terminated on February 29, 2024, and no further sales of our common stock will be made pursuant to the ATM.
Through the date of termination of the ATM, we offered and sold an aggregate of 200,000 shares of our common stock.
These aggregate sales resulted in gross proceeds to us of approximately $ 1.5 million.
During the year ended December 31, 2024, we did not sell any shares of our common stock pursuant to the ATM.
November 2022 Private Placement In November 2022, we entered into subscription agreements with certain accredited investors pursuant to which we sold to the purchasers in a private placement transaction approximately 4,093,141 units at a purchase price of $4.625 per unit, with each unit consisting of two shares of common stock and a common stock purchase warrant to purchase one share of common stock, or the Warrants.
The Warrants are exercisable at a price per share of common stock of $4.50, subject to adjustment.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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