What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-26 compared with 2025-03-27 · 100 added, 70 removed, 181 unchanged (48% of the section changed)

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Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, includes forward-looking statements that involve risks and uncertainties and should be read together with the “Risk Factors” section of this Annual Report on Form 10-K for a discussion of important factors that could cause our actual results to differ materially from those described in or implied by these forward-looking statements contained in the following discussion and analysis.

We are a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to target what we believe to be a key underlying cause of Alzheimer’s disease, or AD.

We are a clinical-stage biopharmaceutical company developing a novel disease-modifying approach targeting what we believe to be a key underlying cause of Alzheimer’s disease, or AD.

Alzheimer’s disease is a progressive neurodegenerative disease of the brain that leads to loss of memory and cognitive functions and ultimately results in death.

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Based on decades of research and supporting evidence, AßOs have gained increasing scientific acceptance as a primary toxin involved in the initiation and propagation of AD pathology.

We are currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug, in our Phase 2 ALTITUDE-AD clinical trial following Phase 1 results in “early AD” patients (patients with mild cognitive impairment or mild dementia due to AD) that were reported in July 2023.

Sabirnetug is a recombinant humanized immunoglobulin gamma 2, or IgG2, monoclonal antibody, or mAb, that was designed to selectively target AßOs, has demonstrated functional and protective effects in in vitro assays, and has demonstrated in vivo safety and pharmacologic activity in multiple animal species, including transgenic mouse models for AD.

In July 2023, we announced topline results from our Phase 1 clinical trial of sabirnetug, called INTERCEPT-AD, which demonstrated that sabirnetug met the primary and secondary objectives of this clinical trial in 62 participants with early AD.

We announced the initiation of our Phase 2 ALTITUDE-AD clinical trial of sabirnetug in May 2024 and completed enrollment in March 2025 .

We expect to announce top-line results for ALTITUDE-AD in late 2026.

ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three-arm clinical trial designed to evaluate the clinical efficacy, safety and tolerability of sabirnetug, with up to 180 participants per arm for a total of up to 540 participants with mild cognitive impairment or mild dementia due to AD.

We are currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug, in our Phase 2 ALTITUDE-AD clinical trial, and expect to announce top-line results in late 2026.

ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three-arm clinical trial designed to evaluate the clinical efficacy, safety and tolerability of sabirnetug with up to 180 participants per arm for a total of 542 participants with mild cognitive impairment or mild dementia due to AD.

We plan to use the Integrated Alzheimer’s Disease Rating Scale at 18 months as the primary outcome measure.

The active doses for ALTITUDE-AD are 35 mg/kg and 50 mg/kg, both dosed intravenously every four weeks.

These dose levels and frequency were selected based on extensive pharmacokinetic and pharmacodynamic modeling of our Phase 1 clinical trial data.

The active doses for ALTITUDE-AD are 35 mg/kg and 50 mg/kg, dosed intravenously every four weeks.

These dose levels and frequency were selected based on extensive pharmacokinetic and pharmacodynamic modeling of our Phase 1 INTERCEPT-AD clinical trial of sabirnetug.

Sabirnetug is a recombinant humanized immunoglobulin gamma 2, or IgG2, monoclonal antibody, or mAb, that was designed to selectively target AßOs.

In July 2023, we announced topline results from INTERCEPT-AD, which demonstrated that sabirnetug met the primary and secondary objectives of this clinical trial in 62 participants with early AD.

We announced the results of a Phase 1 clinical trial investigating a subcutaneous dosing option of sabirnetug in March 2025.

This study in healthy volunteers enrolled 16 subjects who received four weekly subcutaneous doses of 1,200 mg of sabirnetug and 12 subjects who received a single intravenous dose of 2,800 mg of sabirnetug.

The most frequently reported adverse events included injection site reactions (62.5%), all of which were mild (Grade 1) in severity and resolved.

No other safety issues were identified.

Additionally, subcutaneous administration of sabirnetug was shown to produce sufficient systemic exposure to support further development of this formulation as a more convenient administration option for patients.

In addition, we are investigating a blood-brain barrier-penetrating, Aß oligomer-targeted Enhanced Brain Delivery (EBD™) therapy for AD.

In March 2026, we announced certain preclinical data from EBD candidates, including in vitro , in vivo and non-human primate study results, supporting the advancement of the EBD program:

(1) EBD candidates achieved 14-40x higher brain levels in non-human primates compared to native antibodies 24 hours after dosing;

(2) hematology data in non-human primates indicated low potential for anemia, including that, at 24 hours after subcutaneous dosing, EBD candidates demonstrated no observed change in red blood cell count, hematocrit, hemoglobin or reticulocyte count;

and (3) favorable stability profile and enhanced brain delivery support a path to subcutaneous administration with low-volume devices.

Based on this data, an IND is targeted for mid-2027.

In July 2025, we entered into a collaboration, option and license agreement with JCR Pharmaceuticals Co.

Ltd., or JCR, to develop an Aß oligomer-targeted EBD TM therapy for the treatment of AD.

Under the terms of the agreement, in addition to an upfront license payment that we paid to JCR, if we exercise our exclusive option to develop up to two development candidates, JCR will be eligible for an option exercise payment of $9.25 million.

Our option is expected to be exercised when we have selected or identified up to two preclinical candidates we would license and advance into IND-enabling activities.

JCR will also be eligible to receive future milestone payments of up to $40.0 million related to development, and up to $515.0 million related to sales, for a total of up to $555.0 million, as well as single-digit percentage royalties on sales of any products that emerge from the collaboration.

The combination of sabirnetug or additional, novel, AβO-selective antibodies with JCR’s blood-brain barrier-penetrating technology, J-Brain Cargo ® , strengthens Acumen’s portfolio of AβO-targeted therapies.

The partnership is designed to advance potential next-generation treatment options for people living with AD, by targeting the development of products with enhanced efficacy, safety and convenience.

We were incorporated in 1996 and were party to an exclusive license and research collaboration with Merck & Co., Inc., or Merck, in 2003.

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We have funded our operations primarily through the sale of our convertible preferred stock and common stock, the issuance of notes, entry into a term loan facility, grant revenue and, during our collaboration with Merck, certain payments received under our collaboration agreement.

On July 21, 2023, we issued 16,774,193 shares of our common stock in an underwritten public offering, or the Offering, at a price to the public of $7.75 per share.

The net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $121.9 million.

In November 2023, we entered into a loan and security agreement, or the Loan Agreement, with K2 HealthVentures LLC, or, together with its affiliates, K2HV.

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The term loan facility matures on November 1, 2027 and can be extended to November 1, 2028, subject to our achievement of certain financing milestones.

In accordance with

the Loan Agreement, we issued to K2HV a warrant to purchase up to 730,769 shares of our common stock at an exercise price of $1.95 per share.

In January 2024, we issued 2,068,246 shares of our common stock under our at-the-market offering program, or the ATM, for net proceeds of $7.9 million, or $3.84 per share.

In accordance with the Loan Agreement, we issued to K2HV a warrant to purchase up to 730,769 shares of our common stock at an exercise price of $1.95 per share.

On March 13, 2026, we entered into a securities purchase agreement with certain institutional and accredited investors for a private placement, or the Private Placement, of 10,833,331 shares of our common stock, at an offering price of $3.30 per share.

The Private Placement closed on March 16, 2026, for aggregate gross proceeds of approximately $35.75 million, before deducting applicable fees and expenses.

We intend to use the net proceeds from the Private Placement to primarily support our EBD program, including ongoing preclinical development work to support the nomination of a lead clinical candidate molecule, and for working capital and other general corporate purposes.

During the year ended December 31, 2025, no shares of our common stock were issued under our at-the-market offering program, or the ATM.

In January 2024, we issued 2,068,246 shares of our common stock under our ATM, for net proceeds of $7.9 million, or $3.84 per share.

We have incurred net losses and negative cash flows from operations since our inception.

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Approximately $104.9 million , or 86% , of the net loss for the year ended December 31, 2025 was due to research and development spending.

As of December 31, 2024, we had an accumulated deficit of $325.1 million.

Our net losses and cash flows from operations may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of nonclinical studies, clinical trials and our expenditures on other research and development activities.

We expect our expenses and operating losses will increase substantially for the foreseeable future as we advance sabirnetug in clinical trials, seek to expand our product candidate portfolio through developing additional product candidates, grow our clinical, regulatory and quality capabilities, and incur additional costs associated with operating as a public company.

As of December 31, 2025, we had an accumulated deficit of $446.5 million and cash and cash equivalents and marketable securities of $116.9 million .

We expect our expenses and operating losses will increase substantially for the foreseeable future as we advance sabirnetug in clinical development, seek to expand our product candidate portfolio through developing additional product candidates, and incur additional costs associated with operating as a public company.

It is likely that we will seek third-party collaborators for the future commercialization of sabirnetug or any other product candidate that is approved for marketing.

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We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all.

In addition, global economic conditions may impact our ability to raise additional funds, and we may be impacted by disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, rising inflation and supply disruptions, the ongoing conflict between Russia and Ukraine, and Israel and Hamas and related sanctions, and otherwise.

In addition, global economic conditions may impact our ability to raise additional funds, and we may be impacted by disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, tariff policy and geopolitical tensions between the United States and foreign countries, rising inflation and supply disruptions, the ongoing conflicts between Russia and Ukraine, the recent military actions involving Iran, and the Israel-Hamas war and related sanctions, and otherwise.

If these conditions persist and deepen, we could experience an inability to access additional capital, or our liquidity could otherwise be impacted.

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Our failure to raise capital or enter into such agreements as and when needed could have a material adverse effect on our business, results of operations and financial condition.

As of December 31, 2024, we had cash and cash equivalents and marketable securities of $231.5 million;

included in this amount is the first tranche of $30.0 million that we received under our Loan Agreement, which was received on November 10, 2023.

Based on our current operating plan, we expect that our existing cash and cash equivalents and marketable securities, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect, including based on our decision to initiate other clinical trials or programs.

See “Liquidity and Capital Resources.”

We evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern.

Based on our current operating plan, we expect that our current balance of cash and cash equivalents and marketable securities will fund our operations into early 2027, but we believe it will not be enough to fund our operations for at least 12 months from the date of issuance of our financial statements included in this Annual Report on Form 10-K.

Our cash forecast contains estimates and assumptions related to our ongoing clinical trial and other research and development expenses, and we cannot predict the amount or timing of all expenditures with certainty.

Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.

See “Liquidity, Capital Resources and Going Concern.”

Components of Results of Operations

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• costs of conducting nonclinical studies and clinical trials of our product candidates;

• consulting and professional fees related to research and development activities, including stock-based compensation to non-employees;

• consulting and professional fees related to research and development activities, including noncash stock-based compensation to non-employees;

• payments made pursuant to our license agreements;

• costs related to compliance with clinical regulatory requirements;

• employee-related expenses, including salaries, benefits and stock-based compensation expenses for our research and development personnel.

As we currently only have one product candidate, sabirnetug, in development, we do not separately track expenses by program.

• employee-related expenses, including salaries, benefits and noncash stock-based compensation expenses for our research and development personnel.

As we currently only have one product candidate, sabirnetug, in clinical development, we do not separately track expenses by program.

Further, we have historically relied primarily on consultants for research and development activities;

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General and Administrative Expenses

General and administrative expenses consist primarily of employee-related expenses, including stock-based compensation costs, as well as business insurance, management and business consultants and other related costs.

General and administrative expenses also include professional fees for legal, consulting, accounting, auditing, tax and patent services, investor and public relations, recruiting expenses, board of directors’ expenses, information technology, franchise taxes, rent, travel expenses and subscriptions.

We expect that our general and administrative expenses will increase as our organization and headcount required in the future grows to support continued research and development activities and potential commercialization of our product candidates.

General and administrative expenses consist primarily of employee-related expenses, including noncash stock-based compensation costs, as well as business insurance, management and business consultants and other related costs.

General and administrative expenses also include professional fees for legal, consulting, accounting, auditing, tax, patent services, investor and public relations, board of directors’ expenses, information technology, franchise taxes, rent, travel expenses and subscriptions.

We expect that our general and administrative expenses will remain consistent for the foreseeable future and may increase as our organization and headcount required in the future grows to support continued research and development activities and potential commercialization of our product candidates.

These increases will likely include increased costs related to the hiring of additional personnel and fees incurred for outside consultants, attorneys and accountants, among other expenses.

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Interest expense includes interest due under the Loan Agreement, as well as the amortization of the related debt discount.

The change in fair value of embedded derivatives relates to the embedded derivatives that were bifurcated from the term loan, borrowed under the Loan Agreement, and accounted for as a derivative at fair value and which is remeasured at each reporting period for the term of the loan.

The change in fair value of embedded derivatives relates to the embedded derivatives that were bifurcated from the term loan, borrowed under the Loan Agreement, and accounted for as a derivative at fair value which is remeasured at each reporting period for the term of the loan.

Other expense, net generally consists of fees incurred on our investments in marketable securities.

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2025 2024 $ %

Costs and operating expenses

Operating expenses

Research and development $ 104,885 $ 93,798 $ 11,087 12 %

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Research and development expenses were $104.9 million and $93.8 million for the years ended December 31, 2025 and 2024, respectively.

The $51.5 million increase was primarily due to $35.6 million for CRO costs associated with the ALTITUDE-AD clinical trial, for which we announced the dosing of the first patient in May 2024.

Additionally, we incurred $5.3 million for higher personnel-related costs, which included a $1.7 million increase for non-cash stock-based compensation expenses, as well as increases in the following:

$3.2 million for license agreement expenses, $2.9 million for manufacturing and materials, $1.4 million for storage, shipping and packaging, $1.1 million for other research projects, $0.8 million for other clinical trial expenses, $0.5 million for travel and conferences, $0.4 million related to services provided by research and development contractors and consultants and $0.3 million for other miscellaneous costs.

The $11.1 million increase was primarily due to a $15.9 million increase for manufacturing and materials mainly associated with our ALTITUDE-AD clinical trial.

Additionally, we incurred a $2.6 million increase for personnel-related costs, including share-based compensation expense, a $1.1 million increase for other research expenses including EBD research, a $0.6 million increase for shipping, packaging and storage costs, a $0.4 million increase for other clinical trial costs and $0.3 million for other expenses such as insurance and software.

These increased expenses were partially offset by a decrease of $4.7 million for license agreement expense, a $2.3 million decrease in CRO costs associated with our ALTITUDE-AD clinical trial mainly due to pass through costs, a $1.6 million decrease related to services provided by research and development contractors and consultants and a $1.2 million decrease in clinical assay development work.

General and Administrative Expenses

General and administrative expenses were $18.9 million and $20.2 million for the years ended December 31, 2025 and 2024, respectively.

The $1.4 million increase was primarily due to increases of $2.3 million for personnel costs, including an increase of $1.8 million for non-cash stock-based compensation expenses, and $0.3 million for recruiting expenses, partially offset by reductions of $0.5 million in corporate insurance expenses, $0.4 million for consulting expenses and $0.3 million for legal/patent expenses.

The $1.3 million decrease was primarily due to $0.6 million for recruiting expense, $0.4 million for corporate insurance expense and $0.3 million for consulting costs.

Other Income (Expense)

Other income increased by $2.9 million to $11.7 million for the year ended December 31, 2024 from $8.8 million for the year ended December 31, 2023.

The increase was primarily attributable to a $3.5 million increase in interest income on our portfolio of marketable securities due to both higher interest rates and higher average investments in marketable securities during 2024, as well as a $3.0 million increase in change in fair value of embedded derivatives due to the decrease in fair value of the embedded derivatives that are bifurcated from the term loan under the Loan Agreement.

These increases in other income were partially offset by an increase in interest expense of $3.5 million related to our Loan Agreement funded in November 2023 and other expense, net of $0.1 million.

Liquidity and Capital Resources

Other income decreased by $9.2 million to $2.5 million for the year ended December 31, 2025 from $11.7 million for the year ended December 31, 2024.

The decrease was primarily attributable to a $6.9 million decrease in interest income on our portfolio of marketable securities due to a lower average investment balance in marketable securities during the year

ended December 31, 2025.

Additionally, there were increased expenses associated with the change in fair value of our embedded derivatives related to our Loan Agreement of $2.1 million.

These decreases in other income were partially offset by an increase in interest expense of $0.2 million related to our Loan Agreement and other expense, net of $0.1 million.

Liquidity, Capital Resources and Going Concern

We have incurred net losses since inception.

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We have not yet commercialized any products and we do not expect to generate revenue from sales of any drug candidates for at least several years, if ever.

Our operations have been financed primarily by net proceeds from the sale and issuance of our common stock and convertible preferred stock, net proceeds from our initial public offering, or the IPO, and the Offering, the issuance of notes, grant revenue and, during our collaboration with Merck, which was in place from 2003 to 2011, certain payments received under our collaboration agreement.

On July 21, 2023, we issued 16,774,193 shares of our common stock, $0.0001 par value per share, or Common Stock, in the Offering at a price of $7.75 per share.

The aggregate net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $121.9 million.

Our operations have been financed primarily by net proceeds from the sale and issuance of our common stock and convertible preferred stock, net proceeds from our initial and subsequent public offering, the Private Placement and from sales of shares of our common stock under our ATM, borrowings under the Loan Agreement, the issuance of notes, grant revenue and, during our collaboration with Merck, which was in place from 2003 to 2011, certain payments received under our collaboration agreement.

On July 1, 2022, we filed a shelf registration statement on Form S-3, or the 2022 Registration Statement.

Pursuant to the 2022 Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $200.0 million.

In connection with the filing of the Registration Statement, we also entered into a sales agreement, or the Sales Agreement, with BofA Securities, Inc.

and Stifel, Nicolaus & Company, Incorporated, as sales agents, pursuant to which we may issue and sell shares of our Common Stock for an aggregate offering price of up to $50.0 million under an ATM, which is included in the $200.0 million of securities that may be offered pursuant to the Registration Statement.

On April 23, 2023, we entered into an amendment to the Sales Agreement, or, as amended, the Amended Sales Agreement, to add BTIG, LLC as a sales agent under the Amended Sales Agreement.

Pursuant to the Amended Sales Agreement, we will pay the sales agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our Common Stock.

In connection with the filing of the 2022 Registration Statement, we also entered into a sales agreement, or the Sales Agreement, with BofA Securities, Inc., or BofA, and Stifel, Nicolaus & Company, Incorporated, or Stifel, as sales agents, pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $50.0 million under the ATM, which was included in the $200.0 million of securities that were registered for sale pursuant to the 2022 Registration Statement.

On April 23, 2023, we entered into an amendment to the Sales Agreement, or as amended, the Amended Sales Agreement, to add BTIG, LLC, or BTIG, as a sales agent under the Amended Sales Agreement.

BTIG, BofA and Stifel are collectively referred to as the Sales Agents.

Pursuant to the Amended Sales Agreement, we will pay the Sales Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock made under the ATM.

We are not obligated to make any sales of shares of our common stock under the ATM.

In January 2024, we issued 2,068,246 shares of Common Stock under the ATM for net proceeds of $7.9 million, or $3.84 per share.

On July 21, 2023, we issued 16,774,193 shares of our common stock in an underwritten public offering, or the Offering, at a price of $7.75 per share.

The aggregate net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $121.9 million.

On November 10, 2023, we received the first tranche of $30.0 million under the Loan Agreement.

In January 2024, we issued 2,068,246 shares of common stock under the ATM for net proceeds of $7.9 million, or $3.84 per share.

During the year ended December 31, 2025, no shares of our common stock were issued under our ATM.

On March 27, 2024, we filed a shelf registration statement on Form S-3, or the 2024 Registration Statement.

Pursuant to the 2024 Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $200.0 million.

On November 13, 2025, we filed a prospectus supplement to the 2024 Registration Statement with respect to our ATM, designating up to $50.0 million of the $200.0 million of securities that may be offered pursuant to the 2024 Registration Statement for issuance under the ATM.

As of December 31, 2025, we had cash and cash equivalents and marketable securities totaling $116.9 million.

Our available-for-sale marketable securities mature over the next two years.

Based on our current operating plan, we expect that our existing cash and cash equivalents and marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027.

Our available-for-sale marketable securities mature in less than one year.

We could exhaust our available capital resources sooner than we expect, including if we decide to initiate other clinical trials or programs.

We evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern.

Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.

On March 13, 2026, we entered into a Private Placement of 10,833,331 shares of our common stock, at an offering price of $3.30 per share.

The Private Placement closed on March 16, 2026, for aggregate gross proceeds of approximately $35.75 million, before deducting applicable fees and expenses.

We intend to use the net proceeds from the Private Placement to

primarily support our EBD program, including ongoing preclinical development work to support the nomination of a lead clinical candidate molecule, and for working capital and other general corporate purposes.

We enter into contracts in the normal course of business with CROs and CMOs for clinical trials, nonclinical research studies and testing, manufacturing and other services and products for operating purposes.

These contracts do not contain any minimum purchase commitments and are generally cancellable by us after giving a certain amount notice.

These contracts do not contain any minimum purchase commitments and are generally cancellable by us after giving a certain amount of notice.

Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation.

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Net cash used in operating activities $ (115,538) $ (86,215)

Net cash provided by (used in) investing activities 48,027 (171,671)

Net cash provided by financing activities 6,928 151,753

Net cash provided by investing activities 133,933 48,027

Net cash (used in) provided by financing activities (34) 6,928

Net change in cash and cash equivalents and restricted cash $ 18,361 $ (31,260)

Operating Activities

Net cash used in operating activities increased by $43.1 million to $86.2 million for the year ended December 31, 2024, from $43.1 million for the year ended December 31, 2023.

The $50.0 million increase in our net loss for the year ended December 31, 2024, as adjusted for non-cash net expenses totaling $1.0 million, accounted for a $49.6 million increase in cash used in operating activities as compared to the prior year.

Non-cash items included increases in stock-based compensation expense and non-cash interest expense of $3.5 million and $1.0 million, respectively, which were partially offset by an $1.9 million increase in amortization and accretion income on marketable securities, a $2.9 million increase in income related to a change in fair value of embedded derivatives and a $0.7 million decrease in non-cash equipment lease costs.

The adjusted net loss was partially offset by working capital changes of $7.8 million, including increases in cash provided by accrued clinical trial expenses of $9.3 million, accounts payable of $4.5 million and other long-term assets of $0.1 million, partially offset by increases in cash used in prepaid expenses and other current assets of $3.3 million and accrued expenses and other current liabilities of $2.8 million.

The increase in net cash used in operating activities of $29.3 million to $115.5 million for the year ended December 31, 2025, from $86.2 million for the year ended December 31, 2024, is primarily attributable to an increase in net loss for the year ended December 31, 2025 of $19.0 million, a net increase in noncash adjustments of $6.4 million and working capital changes of $16.7 million.

Significant noncash items consisted of decreases in noncash income for amortization and accretion on marketable securities of $4.2 million and the change in fair value of embedded derivatives of $2.0 million.

Working capital changes contributed $16.7 million of additional cash used in operations, including increases in cash used for accrued clinical trial expenses and accounts payable of $15.7 million and $9.3 million, respectively, which were partially offset by cash provided by prepaid expenses and other current assets of $5.0 million and accrued expenses and other liabilities of $3.3 million.

Investing Activities

Net cash provided by investing activities increased by $219.7 million to $48.0 million for the year ended December 31, 2024 from cash used in investing activities of $171.7 million for the year ended December 31, 2023, and was primarily due to an increase in maturities of marketable securities of $139.8 million and a decrease in purchases of marketable securities of $79.9 million.

Net cash provided by investing activities increased by $85.9 million to $133.9 million for the year ended December 31, 2025 from $48.0 million for the year ended December 31, 2024, and was primarily due to a decrease in purchases of marketable securities of $132.7 million, partially offset by a decrease in cash provided by maturities of marketable securities of $46.7 million and an increase of $0.1 million for purchases of property and equipment.

Financing Activities

Net cash provided by financing activities decreased by $144.9 million to $6.9 million for the year ended December 31, 2024 from $151.8 million for the year ended December 31, 2023.

The decrease was primarily due to a reduction in cash provided from the issuance of common stock of $114.0 million, as well as a decrease in proceeds from the term loan of $30.0 million, as well as cash used of $0.7 million for the financing lease and $0.2 million of other costs.

Net cash provided by financing activities during the year ended December 31, 2025 decreased by $7.0 million from cash provided by financing activities of $6.9 million for the year ended December 31, 2024.

Cash provided by financing activities during the year ended December 31, 2024 was primarily due to net proceeds of $7.9 million from the issuance of common stock under our ATM, partially offset by $0.7 million for payment under a finance lease agreement for certain computer equipment for our Phase 2 ALTITUDE-AD clinical trial and $0.2 million for payments related to deferred offering costs.

Funding Requirements

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Should we seek to commercialize our products at our own expense, we would incur significant additional expenses for marketing, sales, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties.

As a result, we expect that we will need to obtain substantial additional funding in connection with our future operations.

As a result, we expect that we will need to obtain substantial additional

funding in connection with our future operations.

If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

Based on our current operating plan, we believe that our existing cash and cash equivalents and marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027.

Based on our current operating plan, we believe there is substantial doubt about our ability to continue as a going concern for at least 12 months following the date of issuance of our financial statements included in this Annual Report on Form 10-K.

We could exhaust our available capital resources sooner than we expect, including if we decide to initiate other clinical trials or programs.

In addition, changing circumstances may cause us to increase our spending significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.

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• the outcome, costs and timing of seeking and obtaining FDA, EMA and any other regulatory approvals;

• our progress and success in investigating EBD TM therapy for AD;

• the number and characteristics of product candidates that we pursue;

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Any funds we raise may not be sufficient to enable us to continue to implement our long-term business strategy.

Further, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide.

Further, our ability to raise additional capital may be adversely impacted by global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, as well as tariff policy and geopolitical tensions between the United States and foreign countries.

Additionally, escalation in interest rates, in conjunction with banking failures, may lead to financial institutions being more prudent with capital deployment and tightening lending.

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• Expected Term —We have opted to use the “si mplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the mid-point between the vesting date and the end of contractual term of the option (generally 10 years).

• Expected Volatility —Due to our limited operating h istory and a lack of sufficient company-specific historical and implied volatility data, we have based our estimate of expected volatility on a blended volatility of the volatility of our stock price following our IPO and the historical volatility of a group of industry peers that are publicly traded.

We will continue to utilize this blended approach to estimate volatility until a sufficient amount of historical information regarding the volatility of our own stock is available.

• Expected Volatility —Prior to January 1, 2025, the Company lacked sufficient company-specific historical and implied volatility information for its common stock and estimated its expected stock volatility using a weighted average blend of historical volatility of a publicly traded set of peer companies, as well as its own historical volatility.

Beginning on January 1, 2025, based on the availability of sufficient historical trading data of the Company’s common stock, the Company began using its historical volatility.

• Risk-Free Interest Rate —The risk-free rate assu mption is based on the U.S.

11 unchanged sentences

The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows.

There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense.

There may be instances in which payments made to our vendors will exceed the level of services provided

and result in a prepayment of the research and development expense.

In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period.

12 unchanged sentences

We calculate the fair value of embedded derivatives using the Monte Carlo option-pricing model, which requires the use of various highly subjective assumptions, including the expected term, expected volatility, risk-free interest rate and expected dividend yield.

Our selection of the expected volatility, risk-free interest rate and expected dividend yield are discussed above under Stock-Based Compensation Expense.

Emerging Growth Company and Smaller Reporting Company Status

13 unchanged sentences

We may choose to take advantage of some but not all of these reduced reporting burdens.

We have taken advantage of certain reduced reporting requirements in this Annual Report on Form 10-K and our other filings with the SEC.

We have taken advantage of certain reduced reporting requirements in this Annual Report

on Form 10-K and our other filings with the SEC.

Accordingly, the information contained herein may be different than you might obtain from other public companies in which you hold equity interests.

We are also a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year.

We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million.

We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million.

If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis