FILANA THERAPEUTICS, INC.
For the period ended Mar 31, 2026. Filed May 7, 2026.
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Mar 31, 2026 · Filed May 7, 2026
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Notes to Condensed Consolidated Financial Statements
Filana Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note1. General and Liquidity
Filana Therapeutics, Inc. and its wholly-owned subsidiary (collectively referred to as the “Company”) discovers and develops proprietary pharmaceutical product candidates that* may*offer significant improvements to patients and healthcare professionals. The Company currently focuses its discovery and product development efforts on disorders of the nervous system.
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and pursuant to the instructions to the Quarterly Report on Form10-Q and Article10 of Regulation S-X. All intercompany transactions and balances have been eliminated in consolidation. Accordingly, the condensed consolidated financial statements donot include all of the information and footnotes required by GAAP for complete consolidated financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included. Operating results for thethree months ended* March 31, 2026* arenot necessarily indicative of the results that* maybe expected for any other interim period or for the year2026.* For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form10-K for the year ended* December 31, 2025*.
Liquidity
The Company has incurred significant net losses and negative cash flows since inception, and as a result has an accumulated deficit of $506.4 million at* March 31, 2026*. The Company expects its cash requirements to be significant in the future. The amount and timing of the Company’s future cash requirements will depend on regulatory and market acceptance of its product candidates and the resources it devotes to researching and developing, formulating, manufacturing, commercializing and supporting its products. The Company* mayseek additional funding through public or private financing in the future, if such funding is available and on terms acceptable to the Company. There areno* assurances that additional financing will be available on favorable terms, or at all. However, management believes that the current working capital position will be sufficient to meet the Company’s working capital needs for at least the next12 months.
Note2. Significant Accounting Policies
Use of Estimates
The Company makes estimates and assumptions in preparing its condensed consolidated financial statements in conformity with GAAP. These estimates and assumptions affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of expenses incurred during the reporting period. The Company evaluates its estimates on an ongoing basis, including those estimates related to legal liabilities, stock-based compensation, clinical trials and manufacturing agreements. Actual results could differ from these estimates and assumptions.
Cash and Cash Equivalents and Concentration of Credit Risk
The Company invests in cash and cash equivalents. The Company considers highly liquid financial instruments with original maturities ofthree months or less to be cash equivalents. Highly liquid investments that are considered cash equivalents include money market accounts and funds, certificates of deposit, and U.S. Treasury securities. The Company maintains its cash and cash equivalents atone financial institution.
Fair Value Measurements
The Company recognizes financial instruments in accordance with the authoritative guidance on fair value measurements and disclosures for financial assets and liabilities. This guidance defines fair value, establishes a framework for measuring fair value in accordance with GAAP, and expands disclosures about fair value measurements. The guidance also establishes athree-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
| ● | Level 1 includes quoted prices in active markets. |
| ● | Level 2 includes significant observable inputs, such as quoted prices for identical or similar securities, or other inputs that are observable and can be corroborated by observable market data for similar securities. The Company uses market pricing and other observable market inputs obtained from third-party providers. It uses the bid price to establish fair value where a bid price is available. The Company does not have any financial instruments where the fair value is based on Level 2 inputs. |
| ● | Level 3 includes unobservable inputs that are supported by little or no market activity. The Company does not have any financial instruments where the fair value is based on Level 3 inputs. |
If a financial instrument uses inputs that fall in different levels of the hierarchy, the instrument will be categorized based upon the lowest level of input that is significant to the fair value calculation. The fair value of cash and cash equivalents was based on Level1 inputs at* March 31, 2026* and* December 31, 2025*.
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Business Segments
The Company reports segment information based on how it internally evaluates the operating performance of its business units, or segments. The Company’s operations are confined toone business segment: the development of novel drugs and diagnostics.
The Company’s reportable segment reflects the manner in which its chief operating decision maker (“CODM”) allocates resources and assesses performance. The Company's CODM is the President and Chief Executive Officer. The primary measure used by the Company's CODM for purposes of allocating resources is based on net loss that also is reported on the consolidated statements of operations as consolidated net loss. The measure of segment assets is reported on the condensed consolidated balance sheets as cash and cash equivalents.
The Company hasnot generated any product revenue in the current period and expects to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through stages of development and clinical trials.
As such, the CODM uses cash forecast models in deciding how to invest in the development of novel drugs and diagnostics. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.
The following table summarizes expenses by category regularly reviewed by the CODM (in thousands):
| Three months ended | ||
|---|---|---|
| March 31, | ||
| 2026 | 2025 | |
| Operating expenses | ||
| Research and development | $(4,544) | $(13,666) |
| General and administrative | (6,624) | (10,920) |
| Other segment items(a) | 837 | 1,183 |
| Net loss | $(10,331) | $(23,403) |
(a) Other segment items include interest income and other income (loss), net.
The following table summarizes assets regularly reviewed by the CODM (in thousands):
| March 31, 2026 | December 31, 2025 | |
|---|---|---|
| Cash and cash equivalents | $86,573 | $95,502 |
For thethree months ended* March 31, 2026and2025,* the net cash used in operating activities was $8.9 million and $11.3 million, respectively.
Stock-based Compensation
The Company recognizes non-cash expense for the fair value of all stock options and other share-based awards. The Company uses the Black-Scholes option valuation model to calculate the fair value of stock options, using the single-option award approach and straight-line attribution method. This model requires the input of subjective assumptions including expected stock price volatility, expected life and estimated forfeitures of each award. These assumptions consist of estimates of future market conditions, which are inherently uncertain, and therefore, are subject to management's judgment. For all options granted, it recognizes the resulting fair value as expense on a straight-line basis over the vesting period of each respective stock option, generallyone tofour years.
The Company has granted share-based awards that vest upon achievement of certain performance criteria (“Performance Awards”). The Company multiplies the number of Performance Awards by the fair value of its common stock on the date of grant to calculate the fair value of each award. It estimates an implicit service period for achieving performance criteria for each award. The Company recognizes the resulting fair value as expense over the implicit service period when it concludes that achieving the performance criteria is probable. It periodically reviews and updates as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance Awards vest and common stock is issued upon achievement of the performance criteria.
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Net Loss per Share
The Company computes basic net loss per share on the basis of the weighted-average number of common shares outstanding for the reporting period. Diluted net loss per share is computed on the basis of the weighted-average number of common shares outstanding plus potential dilutive common shares outstanding using the treasury-stock method. Potential dilutive common shares consist of outstanding common stock options and Performance Awards. There isno difference between the Company’s net loss and comprehensive loss. The numerators and denominators in the calculation of basic and diluted net loss per share were as follows (in thousands, except net loss per share data):
| Three months ended | ||
|---|---|---|
| March 31, | ||
| 2026 | 2025 | |
| Numerator: | ||
| Net loss | $(10,331) | $(23,403) |
| Denominator: | ||
| Shares used in computing net loss per share, basic and diluted | 48,308 | 48,262 |
| Net loss per share, basic and diluted | $(0.21) | $(0.48) |
| Dilutive common stock options excluded from net loss per share, diluted | 3,972 | 3,751 |
| Dilutive Performance Awards excluded from net loss per share, diluted | 7 | 7 |
The Company excluded all common stock options and Performance Awards outstanding for thethree months ended* March 31, 2026and2025* from the calculation of net loss per share, diluted, because the effect of including outstanding options and Performance Awards would have been anti**-**dilutive.
Fair Value of Financial Instruments
Financial instruments include accounts payable, accrued expenses, accrued development expense and other liabilities. The estimated fair value of certain financial instruments* maybe determined using available market information or other appropriate valuation methodologies. However, considerable judgment is required in interpreting market data to develop estimates of fair value; therefore, the estimates arenot* necessarily indicative of the amounts that could be realized or would be paid in a current market exchange. The effect of using different market assumptions and/or estimation methodologies* may*be material to the estimated fair value amounts. The carrying amounts of accounts payable, accrued expenses, accrued development expense and other liabilities are at cost, which approximates fair value due to the short maturity of those instruments.
Research Contracts, Prepaids and Accruals
The Company has entered into various research and development contracts with research institutions and otherthird-party vendors. These agreements are generally cancelable. Related payments are recorded as research and development expenses as incurred. The Company records prepaids and accruals for estimated ongoing research costs. When evaluating the adequacy of prepaid expenses and accrued liabilities, the Company analyzes progress of the studies including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the prepaid and accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical prepaid and accrual estimates havenot been materially different from actual costs.
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Incentive Bonus Plan
In2020, the Company established the2020 Cash Incentive Bonus Plan (the “CIB Plan”) to incentivize CIB Plan participants. Awards under the CIB Plan are accounted for as liability awards under ASC718 “Stock-based Compensation”. The fair value of each potential CIB Plan award will be determined once a grant date occurs and will be remeasured each reporting period. Compensation expense associated with the CIB Plan will be recognized over the expected achievement period for each CIB Plan award, when a Performance Condition (as defined below) is considered probable of being met. See Note9 for further discussion of the CIB Plan.
Property and Equipment
Property and equipment are recorded at cost, net of accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets. Owned buildings and related improvements have estimated useful lives of 39 years and approximately 10 years, respectively. Tenant improvements are amortized using the straight-line method over the useful lives of the improvements or the remaining term of the corresponding leases, whichever is shorter.
Property and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset* may**not* be recoverable. If property and equipment are considered to be impaired, an impairment loss is recognized.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax balances are adjusted to reflect tax rates based on currently enacted tax laws, which will be in effect in the years in which the temporary differences are expected to reverse. The Company has accumulated significant deferred tax assets that reflect the tax effects of net operating loss and tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Realization of certain deferred tax assets is dependent upon future earnings. The Company is uncertain about the timing and amount of any future earnings. Accordingly, the Company offsets these deferred tax assets with a valuation allowance.
The Company accounts for uncertain tax positions in accordance with ASC740, “Income Taxes”, which clarifies the accounting for uncertainty in tax positions. These provisions require recognition of the impact of a tax position in the Company’s condensed consolidated financial statements only if that position is more likely thannot of being sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected as a component of income tax expense.
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Recently Issued Accounting Pronouncements
In* November 2024,the FASB issued ASU2024*-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220-40): Disaggregation of Income Statement Expenses. This ASU includes amendments that require entities to bifurcate specified expense line items on the income statement into underlying components, including employee compensation, depreciation, and intangible asset amortization, as applicable. Qualitative descriptions of the remaining components are required. These enhanced disclosures are required for both interim and annual periods. In* January 2025,the FASB subsequently issued ASU2025*-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220-40): Clarifying the Effective Date, to provide clarification on the ASU's effective date. The new standard is effective for fiscal years beginning after* December 15, 2026on a prospective basis with the option to apply it retrospectively, and for interim periods within fiscal years beginning after December 15, 2027.*Early adoption is permitted. The adoption of this guidance will result in the Company being required to include enhanced disclosures around income statement expenses.
Note3. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets at* March 31, 2026* and* December 31, 2025* consisted of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Prepaid insurance | $253 | $493 |
| Contract research organization and other deposits | 801 | 1,530 |
| Interest receivable | 117 | 120 |
| Other | 220 | 64 |
| Total prepaid expenses and other current assets | $1,391 | $2,207 |
Contract research organization and other deposits represent cash payments made to vendors in excess of expenses incurred.
Note4. Real Property and Other Income, Expense
The Company owns atwo-building office complex in Austin, Texas, a portion of which serves as its corporate headquarters. Maintenance, physical facilities, leasing, property management and other key responsibilities related to property ownership are outsourced to professional real-estate managers. The office complex has approximately 90,000 square feet of rentable space. At* March 31, 2026*, the Company occupied approximately 25% of the property with the remainder either leased or available for lease tothird parties.
The Company records the net income (loss) from building operations and leases as other income (loss), net, as leasing isnot core to the Company’s operations. Building depreciation and amortization for spacenot occupied by the Company is included in general and administrative expense. Building depreciation and amortization for space occupied by the Company is allocated between general and administrative expense and research and development expense. Components of other income (loss), net, for the periods presented were as follows (in thousands):
| Three months ended | ||
|---|---|---|
| March 31, | ||
| 2026 | 2025 | |
| Lease revenue | $253 | $135 |
| Property operating expenses | (206) | (217) |
| Other income (loss), net | $48 | $(82) |
The Company had accrued property taxes related to the building totaling $46,000 and $178,000 at* March 31, 2026and December 31, 2025,*respectively, included in other current liabilities.
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Gross rental income under existingthird-party leases at* March 31, 2026*is as follows (in millions):
| For the year ending December 31, | |
|---|---|
| 2026 | 0.6 |
| 2027 | 0.6 |
| 2028 | 0.5 |
| 2029 | 0.5 |
| 2030 and beyond | 1.0 |
| Total gross rental income | 3.2 |
Note5. Property and equipment
The components of property and equipment, net, as of* March 31, 2026* and* December 31, 2025* were as follows (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Land | $3,734 | $3,734 |
| Buildings | 15,980 | 15,980 |
| Site improvements | 494 | 494 |
| Tenant improvements | 3,468 | 3,468 |
| Furniture and equipment | 891 | 891 |
| Construction in progress | 25 | 25 |
| Other | 181 | 193 |
| Gross property and equipment | $24,773 | $24,785 |
| Accumulated depreciation | (4,370) | (4,139) |
| Property and equipment, net | $20,403 | $20,646 |
Depreciation expense for property and equipment was $0.2 million for thethree months ended* March 31, 2026and2025*.
Note6. Stockholders’** Equity and Stock-Based Compensation Expense**
Stock Option and Performance Award Activity in2026
During thethree months ended* March 31, 2026*, stock options and unvested Performance Awards outstanding under the Company’s stock option plans changed as follows:
| Stock Options | Performance Awards | |
|---|---|---|
| Outstanding as of December 31, 2025 | 4,157,094 | 7,142 |
| Options granted | — | — |
| Options exercised | — | — |
| Options forfeited/canceled | — | — |
| Outstanding as of March 31, 2026 | 4,157,094 | 7,142 |
The weighted average exercise price per share of options outstanding at* March 31, 2026* was $15.01. As outstanding options vest over the current remaining vesting period of 2.2 years, the Company expects to recognize stock-based compensation expense of $19.9 million. If and when outstanding Performance Awards vest, the Company will recognize stock-based compensation expense of $0.1 million over the implicit service period.
During thethree months ended* March 31, 2026,*there wereno stock options exercised.
Stock-based Compensation Expense in2026
During thethree months ended* March 31, 2026and2025*, the Company’s stock-based compensation expense was as follows (in thousands):
| Three months ended | ||
|---|---|---|
| March 31, | ||
| 2026 | 2025 | |
| Research and development | $1,333 | $2,372 |
| General and administrative | 2,736 | 2,853 |
| Total stock-based compensation expense | $4,069 | $5,225 |
The Company estimates forfeitures for each award in determining stock-based compensation expense. There wereno estimated forfeitures during thethree months ended* March 31, 2026.The Company recorded $0.8 million of estimated forfeitures during thethree* months ended* March 31, 2025**.*
2018 Equity Incentive Plan
The Company’s Board of Directors (the “Board”) or a designated committee of the Board is responsible for administration of the Company’s2018 Omnibus Incentive Plan, as amended in* May 2022 (the“2018* Plan”) and determines the terms and conditions of each option granted, consistent with the terms of the2018 Plan. The Company’s employees, directors, and consultants are eligible to receive awards under the2018 Plan, including grants of stock options and Performance Awards. Share-based awards generally expire 10 years from the date of grant. The2018 Plan provides for issuance of up to 5,000,000 shares of common stock, par value $0.001 per share, subject to adjustment as provided in the2018 Plan.
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When stock options or Performance Awards are exercised net of the exercise price and taxes, the number of shares of stock issued is reduced by the number of shares equal to the amount of taxes owed by the award recipient and that number of shares are cancelled. The Company then uses its cash to pay tax authorities the amount of statutory taxes owed by and on behalf of the award recipient.
Note7. Income Taxes*** ***
The Company didnot provide for income taxes during thethree months ended* March 31, 2026* because it has projected a taxable net loss for the full year2026 for which any benefit will be offset by an increase in the valuation allowance. There was alsono provision for income taxes for thethree months ended* March 31, 2025*.
Note8. Commitments
The Company conducts its product research and development programs through a combination of internal and collaborative programs that include, among others, arrangements with universities, contract research organizations and clinical research sites. The Company has contractual arrangements with these organizations that are cancelable. The Company’s obligations under these contracts are largely based on services performed. The Company also had non-cancellable commitments for the manufacture of simufilam's active pharmaceutical ingredient totaling approximately $0.4 million recorded in prepaid expenses and other current assets at* March 31, 2026.*The Company is dependent on contract development and manufacturing organizations for the manufacture of all our materials for clinical studies.
On* February 26, 2025,the Company entered into a License Agreement (the “License Agreement”) with Yale University (“Yale”) pursuant to which the Company was granted exclusive worldwide rights, with rights to sublicense, to Yale’s interest in certain patent and other intellectual property rights that could be useful or necessary to the development and commercialization of simufilam for the treatment of Tuberous Sclerosis Complex (TSC)-related epilepsy and other potential indications. Pursuant to the License Agreement, the Company has agreed to use reasonable commercial efforts to implement a plan that it has designed for such development and commercialization. In exchange for the rights acquired pursuant to the License Agreement, the Company paid Yale (i) a nominal upfront license fee, and agreed to pay (ii) payments upon the achievement of specified clinical, regulatory and commercial milestones, totaling up to $4.5 million and (iii) upon transfer to athird* party in connection with a regulatory priority review voucher, if issued, a low-to-mid double digit percentage of any consideration received for such transfer. The Company also agreed to pay Yale tiered royalties, ranging from a low- to mid- single digit percentage, on aggregate net sales of licensed products, subject to tiered minimum annual royalty payments ranging from the low- to mid- hundreds of thousands of dollars. There wereno License Agreement payments made, other than the nominal upfront license fee, during thethree months ended* March 31, 2026and the year ended December 31, 2025.*
Unless earlier terminated, the License Agreement will continue on a country-by-country basis until the later of (i) the date on which the last valid claim of the license patents expires or otherwise lapses, (ii) the end of any government or regulatory exclusivity period, and (iii)10 years following the date offirst sale of licensed product in such country.
Note 9. ** 2020 Cash Incentive Bonus Plan**
In* August 2020,the Board approved the CIB Plan. The CIB Plan was subsequently amended, as described below on March 6, 2025.The CIB Plan was established as an “at-risk” cash bonus program that would reward CIB Plan participants with additional cash compensation in lockstep with significant increases in the Company’s market valuation (as measured by market capitalization or potential merger consideration). The CIB Plan is considered “at-risk” because CIB Plan participants willnot* receive a cash bonus unless the Company’s market valuation increases significantly and certain other conditions specified in the CIB Plan are met. Specifically, CIB Plan participants willnot be paid any cash bonuses unless (1) the Company completes a merger or acquisition transaction that constitutes a sale of ownership of the Company or its assets (a Merger Transaction) or (2) the Compensation Committee of the Board (the Compensation Committee) determines the Company has sufficient cash on hand, as defined in the CIB Plan. CIB Plan participants will be paid all earned cash bonuses allocated under the CIB Plan in the event of a Merger Transaction.
Because of the inherent discretion and uncertainty regarding the CIB Plan requirements, the Company has concluded that a CIB Plan grant date hasnot occurred as of* March 31, 2026.*
The Company’s market valuation for purposes of the CIB Plan is determined based on either (1) the closing price ofone share of the Company's common stock on the Nasdaq Capital Market multiplied by the total issued and outstanding shares and options to purchase shares of the Company, or (2) the aggregate consideration payable to security holders of the Company in a Merger Transaction. This constitutes a market condition under applicable accounting guidance.
The CIB Plan (as amended* March 6, 2025)triggers a potential cash bonus each time the Company’s market valuation increases significantly, up to a maximum $5 billion in market capitalization (or up to a maximum $8 billion in merger consideration). The CIB Plan specifies incremental amounts between $200 million and $5 billion in market capitalization (or $8 billion in merger consideration) (each increment, a “Valuation Milestone”). Each Valuation Milestone triggers a potential cash bonus award in a pre-set amount defined in the CIB Plan. Each Valuation Milestone based on market capitalization must be achieved and maintained forno* less than 20 consecutive trading days for CIB Plan participants to be eligible for a potential cash bonus award (the “Market Capitalization Conditions”).
Payment of cash bonuses is deferred until such time as (1) the Company completes a Merger Transaction, or (2) the Compensation Committee determines the Company has sufficient cash on hand to render payment (each, a “Performance Condition”), neither of which* mayever occur. Accordingly, CIB Plan participants may*never be paid a cash bonus that is awarded under the CIB Plan, even if the Company’s market capitalization increases significantly.
The CIB Plan is accounted for as a liability award. The fair value of each Valuation Milestone award will be determined once a grant date occurs and will be remeasured each reporting period. Compensation expense associated with the CIB Plan will be recognized over the expected achievement period for each of the Valuation Milestones, when a Performance Condition is considered probable of being met.
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In* October 2020,the Company achieved thefirst* Valuation Milestone based on market capitalization. Subsequently in2020, the Compensation Committee approved a potential cash bonus award of $6.5 million in total for all CIB Plan participants (after taking into account a* March 2023CIB Plan amendment), subject to future satisfaction of a Performance Condition. There isno* continuing service requirement for CIB Plan participants once the Compensation Committee approves a cash bonus award.
During the year ended* December 31, 2021,the Company achieved 11 additional Valuation Milestones based on market capitalization. The achievement of these 11 milestones in2021* triggered a non-discretionary potential Company obligation to the Company’s Chairman, President and CEO (assuming such person holds allthree such offices) of $74.3 million (after taking into account a* March 2023CIB Plan amendment) and contingent upon future satisfaction of a Performance Condition. However,no compensation expense has been recorded andno* payments have been made sinceno grant date has occurred andno Performance Conditions are considered probable of being met.
No Valuation Milestones were achieved during thethree months ended* March 31, 2026and the years ended December 31, 2025,*2024, 2023 and2022.
On* February 13, 2025,the Compensation Committee concluded thatno discretionary cash bonus amounts would be awarded for the 11 Valuation Milestones achieved in2021* nor for any remaining CIB Plan Valuation Milestones which havenot been achieved. Thus, the only CIB Plan participant who could be eligible for cash bonus amounts based on future Valuation Milestone achievement is the Chairman, President and CEO (assuming such person holds allthree such offices), providing that, other than in connection with a Merger Transaction,no bonus payments will be made to such person unless and until the U.S. Food and Drug Administration has approved simufilam for any indication.
As discussed in Note10, on* January 24, 2025,the Delaware Court of Chancery entered a Final Order and Judgment approving the Stipulation and dismissing an action related to the CIB Plan with prejudice. The Final Order and Judgment required the Company to further amend the CIB Plan, as provided in the Stipulation, which was completed on March 6, 2025.The March 6, 2025Amendment specifies that upon the occurrence of a Merger Transaction, the Chairman, President and CEO (assuming such person holds allthree* such offices) willnot be entitled to any payments in respect of any Market Capitalization Conditions, but will instead be entitled to receive a bonus payment based upon the Merger Transaction only. Cash bonuses to the Chairman, President and CEO (assuming such person holds allthree offices) arenot subject to discretionary allocation under the CIB Plan.No person currently holds allthree offices of Chairman, President and CEO.
No actual cash payments were authorized or made to participants under the CIB Plan through* March 31, 2026and the date of filing of this Quarterly Report on Form10*-Q.
Note10. Contingencies
The Company is, and from time to time, the Company* maybecome, involved in litigation or other legal proceedings and claims, including U.S. government inquiries, investigations and Citizen Petitions submitted to the U.S. Food and Drug Administration (“FDA”). In addition, the Company has received, and from time to time may*receive, inquiries from government authorities relating to matters arising from the ordinary course of business. The outcome of these proceedings is inherently uncertain. Regardless of outcome, legal proceedings can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. At this time,no assessment can be made as to their likely outcome or whether the outcome will be material to the Company other than as disclosed below. The Company believes that its total provisions for legal matters are adequate based upon currently available information.
Government Investigations
Beginning in* August 2021,*the Company received subpoenas and other requests for documents and information from the Department of Justice Fraud Section (“DOJ”), document requests from the SEC, and a Civil Investigative Demand from the Civil Division of the Department of Justice. These requests sought corporate information and documents concerning the research and development of simufilam and/or SavaDx, and the Company cooperated fully with each.
On* September 26, 2024,the Company announced that it had reached a settlement with the SEC resolving the SEC investigation of the Company’s disclosures regarding its Phase2b* clinical trial of simufilam for the treatment of Alzheimer’s disease (the “Phase2b Study”) and related matters. The SEC also agreed to a settlement withtwo former senior employees of the Company. Pursuant to these settlements, the U.S. District Court for the Western District of Texas (the “Texas District Court”) entered final consent judgment on* October 18, 2024,on a complaint filed by the SEC against the Company and itstwo* former senior employees. The Company has neither admitted nor denied the allegations of the complaint. The SEC’s complaint alleged that certain disclosures by the Company regarding the Phase2b Study violated certain federal securities laws and SEC rules, including negligence-based disclosure violations of Sections17(a)(2) and17(a)(3) of the Securities Act of1933, as amended (the “Securities Act”), as well as recordkeeping and reporting requirements under the Securities Exchange Act of1934, as amended (the “Exchange Act”). The complaint alleges that the Company’s SEC reports and other public statements regarding the Phase2b Study negligently contained materially misleading statements and omissions. The SEC’s allegations with respect to the Company’stwo former employees relate to these employees’ roles in such disclosures. Under its settlement, the Company consented to a permanent injunction against future violations of Section17(a) of the Securities Act, Section13(a)(1) of the Exchange Act and Rules12b-20, 13a-1, 13a-11 and13a-13 under the Exchange Act. In addition, the Company paid a civil monetary penalty of*$40* million in* November 2024.*
On* February 18, 2026,the DOJ notified the Company that it had closed its inquiry into the Company regarding allegations of research misconduct as described in the indictment inUnited States* v. Wang,8:24-cr-000211-TDC (D. Md.). As previously disclosed, that indictment was dismissed with prejudice by DOJ on* October 23, 2025.*
These outcomes end the previously disclosed investigations of the Company by the DOJ and SEC.
Securities Class Actions and Shareholder Derivative Actions
Between* August 27, 2021and October 26, 2021,*four putative class action lawsuits were filed alleging violations of the federal securities laws by the Company and certain named officers. The complaints rely on allegations contained in Citizen Petitions submitted to FDA and allege that various statements made by the defendants regarding simufilam were rendered materially false and misleading. The Citizen Petitions were all subsequently denied by FDA. These actions were filed in the Texas District Court. The complaints seek unspecified compensatory damages and other relief on behalf of a purported class of purchasers of the Company’s securities.
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On* June 30, 2022,a federal judge consolidated thefour class action lawsuits intoone case (the “Consolidated Securities Action”) and appointed a lead plaintiff and a lead counsel. Lead plaintiff filed a consolidated amended complaint on August 18, 2022on behalf of a putative class of purchasers of the Company’s securities between September 14, 2020and July 26, 2022.On May 11, 2023,the Texas District Court dismissed with prejudice plaintiffs’ claims against defendant Nadav Friedmann, PhD, MD, our former Chief Medical Officer and a Company director, who is now deceased, but otherwise denied defendants’ motion to dismiss. Defendants filed an answer to the consolidated amended complaint on July 3, 2023.On February 22, 2024,plaintiffs filed a motion to supplement their complaint to extend the putative class period through October 12, 2023.The Texas District Court granted that Motion on June 12, 2024,and plaintiffs filed a supplemental complaint on June 13, 2024.*
On* February 2, 2024,a putative class action lawsuit was filed alleging violations of the federal securities law by the Company and certain named officers. The complaint relies on an October 12, 2023article that describes a purported leaked report of alleged scientific misconduct by a scientific collaborator of the Company at City University of New York (the “CUNY Article”). The complaint alleges that various statements made by the defendants regarding simufilam were rendered materially false and misleading by this article. The action was filed in the U.S. District Court for the Northern District of Illinois (the “Illinois District Court”). The complaint seeks unspecified compensatory damages and other relief on behalf of a purported class of purchasers of the Company’s securities between August 18, 2022and October 12, 2023.On May 28, 2024,*the Illinois District Court transferred this action to the Texas District Court, where it was consolidated into the Consolidated Securities Action.
On* November 13, 2024,Plaintiffs in the Consolidated Securities Action filed asecond* motion to supplement their complaint. On* March 13, 2024,plaintiffs filed a Motion for Class Certification. On February 25, 2025,the Texas District Court denied Plaintiff’s motion for class certification without prejudice, explaining that rulings on pending motions, including specifically Plaintiffs’second motion to supplement their complaint, could affect disposition of class certification. On May 21, 2025,the Texas District Court granted Plaintiffs’second motion for leave to file asecond* supplemented complaint and instructed Plaintiffs to refile their motion for class certification. Plaintiffs filed theirsecond supplemental complaint on* May 22, 2025,and reasserted their motion for class certification on June 20, 2025.The Texas District Court granted Plaintiffs’ motion for class certification on August 12, 2025.On October 21, 2025,the United States Court of Appeals for the Fifth Circuit agreed to hear Defendants’ interlocutory appeal challenging the District Court order granting class certification. Briefing was completed on April 20, 2026.*
The parties to the Consolidated Securities Action engaged in mediation with David M. Murphy of Phillips Alternative Dispute Resolutions Enterprises (the “Mediator”) beginning in* May 2025.On December 19, 2025,plaintiffs in the Consolidated Securities Action filed a Final Alternative Dispute Resolution (“ADR”) Report with the Texas District Court as required by Local Rule CV-88(g). As stated in the Final ADR Report, the Company andone* of its officers (the “Settling Defendants”) and plaintiffs have accepted a double-blind Mediator’s Recommendation, reflected in a binding term sheet (the “Term Sheet”) pursuant to which the Settling Defendants will pay plaintiffs $31.25 million to achieve a complete settlement of all claims and causes of action that have been or could be asserted by Plaintiffs in exchange for full and complete releases. The Final ADR Report further states that, although defendants Remi Barbier and Lindsay Burns (the “Non-Settling Defendants”), didnot execute the Term Sheet, those individuals are indemnified by the Company and under the Term Sheet are entitled to receive full and complete releases along with Settling Defendants upon final approval of a settlement by the Texas District Court.
The Term Sheet provides that the Company will pay a settlement amount equal to $31.25 million, which is expected to be placed into escrow after the Settling Defendants and plaintiffs enter a formal stipulation of settlement. In exchange, the plaintiffs and the class will grant full and complete releases in favor of the Settling Defendants and the Non-Settling Defendants of all of their claims that were or could have been asserted in the Consolidated Securities Action and will dismiss with prejudice the claims asserted against the Non-Settling Defendants. The settlement isnot an admission of fault or wrongdoing by the Company or any of the other defendants.
The Settling Defendants and plaintiffs intend to prepare a formal stipulation of settlement and motion for preliminary approval of the settlement describing the terms of the proposed settlement, which will be presented to the Texas District Court for preliminary approval. Following preliminary approval of the proposed settlement by the Texas District Court and a notice and review period for class members, plaintiffs will seek final approval of the proposed settlement from the Texas District Court.
The Company recorded a loss contingency of $31.25 million in accounts payable and other accrued expenses in the Consolidated Balance Sheets at* March 31, 2026and December 31, 2025*relating to the Consolidated Securities Action.
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On* November 4, 2021,a shareholder derivative action related to the initialfour* class action lawsuits filed in the Texas District Court was filed, purportedly on behalf of the Company, in the Texas District Court, asserting claims under the U.S. securities laws and state fiduciary duty laws against certain named officers and the members of the Company’s Board. This complaint relies on the allegations made in Citizen Petitions that were submitted to (and subsequently denied by) FDA. The complaint alleges, among other things, that the individual defendants exposed the Company to unspecified damages and securities law liability by causing it to make materially false and misleading statements, in violation of the U.S. securities laws and in breach of their fiduciary duties to the Company. The derivative case seeks, among other things, to recover unspecified compensatory damages on behalf of the Company arising out of the individual defendants’ alleged wrongful conduct. Although the plaintiff in this derivative case doesnot seek relief against the Company, the Company has certain indemnification obligations to the individual defendants. Between* November 4, 2021and November 9,2023, five additional shareholder derivative actions were filed alleging substantially similar claims, three in the Texas District Court, one in Texas state court (Travis County District Court) andone in the Delaware Court of Chancery. As of November 12, 2025,*thefour actions in the Texas District Court are all consolidated into a single action.
Beginning on* March 18, 2024,two shareholder derivative actions related to the February 2024class action lawsuit originally filed in the Illinois District Court were filed, purportedly on behalf of the Company, in the Illinois District Court, asserting claims under the U.S. securities laws and state fiduciary duty laws against certain named officers and the members of the Company’s Board. The complaints rely on the CUNY Article. The complaints allege, among other things, that the individual defendants exposed the Company to unspecified damages and securities law liability by causing it to make materially false and misleading statements, in violation of the U.S. securities laws and in breach of their fiduciary duties to the Company. The derivative cases seek, among other things, to recover unspecified compensatory damages on behalf of the Company arising out of the individual defendant’s alleged wrongful conduct. Although the plaintiffs in these derivative cases donot* seek relief against the Company, the Company has certain indemnification obligations to the individual defendants. On* September 6, 2024,thesetwo cases were consolidated and stayed pending further developments in the shareholder class action initially filed in the Illinois District Court on February 2, 2024.*Due to the stage of the foregoing shareholder derivative actions, the Company is unable to predict the outcome or estimate the amount of loss or range of losses that could potentially result from such derivative lawsuits.
On* December 13, 2024,a putative class action lawsuit (the“2024* Securities Class Action”) was filed, purportedly on behalf of the Company, alleging violations of the federal securities law by the Company and certain named officers. The complaint alleged that various statements made by the defendants regarding simufilam were revealed to be materially false and misleading by the release of top-line results for the Company’s RETHINK-ALZ Phase3 clinical trial on* November 25, 2024.The2024* Securities Class Action was filed in the Texas District Court. The complaint sought unspecified compensatory damages and other relief on behalf of a purported class of purchasers of the Company’s securities between* February 7, 2024,and November 24, 2024.*
On* May 8, 2025,the Court appointed a lead plaintiff and lead counsel for the2024* Securities Class Action. Lead plaintiff filed an amended complaint on* August 25, 2025,on behalf of a putative class of purchasers of the Company’s securities between October 13, 2023and March 25, 2025.The amended complaint added new officer defendants and additional allegations that various statements made by the defendants regarding simufilam were revealed to be materially false and misleading by disclosures in June 2024through September 2024.On September 19, 2025,defendants filed a motion to consolidate the2024* Securities Class Action into the Consolidated Securities Action. Lead plaintiff opposed that motion, and it remains pending.
On* November 6, 2025,Defendants moved to dismiss the2024* Securities Class Action. Lead plaintiff opposed that motion, and it remains pending.
Due to the stage and procedural posture of the2024 Securities Class Action, the Company is unable to predict the likelihood of an unfavorable outcome in the2024 Securities Class Action. It is reasonably possible, however, that the Company* may*incur a loss. The Company is unable to reasonably estimate the amount or range of potential loss at this time.
Subject to the Term Sheet in the Consolidated Securities Action, the Company intends to defend all pending shareholder derivative actions and securities class actions vigorously.
Anti-SLAPP Lawsuit
On* August 6, 2024,a lawsuit was filed in the District Court for the Southern District of New York which, as amended and as joined by intervenor plaintiffs, asserts claims, including a claim under the New York Anti-SLAPP Law, against the Company and againsttwo former officers to whom the Company has certain indemnification obligations. The amended complaint and the complaint in intervention seeks costs and damages relating to a defamation action filed by the Company against the plaintiffs and subsequently dismissed voluntarily and without prejudice by the Company. The Company and itstwo* former officers named as defendants have entered comprehensive settlement agreements with the intervenor plaintiffs and another potential plaintiff under which the parties provided mutual releases and the Company paid approximately $2.5 million in* October 2025.*The Company intends to defend vigorously the claims brought by the remaining plaintiffs.
Litigation Contingencies
In connection with ongoing litigation, the Company has reserved an amount of $32.75 million, including the $31.25 million loss contingency for the Consolidated Securities Action, for potential settlements at* March 31, 2026and December 31, 2025which was recorded in accounts payable and other accrued expenses. There wasno loss contingency expense recorded during thethree* months ended* March 31, 2026.The Company recorded loss continency expenses totaling $3.0 million during thethree* months ended* March**31,* 2025. The Company believes that the likelihood of an unfavorable outcome is reasonably possible and has accrued this amount as the best estimate of potential loss. The final outcome of the litigation in which the Company is involved* maydiffer from the reserved amount, and additional losses may*be incurred.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.