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Acumen Pharmaceuticals, Inc.

For the period ended Mar 31, 2025. Filed May 13, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 13, 2025

ABOS$0.22+4.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-09-30; filed 2024-11-12.

0001576885-24-000098

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-03-31; filed 2025-05-13.

0001576885-25-000065

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 89 previous paragraphs and 88 current paragraphs.

53 unchanged; 24 reworded; 10 added; 11 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 3 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (10)

Current report

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 single intravenous doses 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.

Current report

General and administrative expenses were $5.1 million and $5.3 million for the three months ended March 31, 2025 and 2024, respectively. The$0.2 million decrease was primarily due to immaterial decreases in personnel costs, insurance and recruiting costs, which were partially offset by a small increase in legal expenses.

Current report

Other income decreased by$1.3 million to $1.6 million for the three months ended March 31, 2025 from $2.9 million for the three months ended March 31, 2024. The$1.3 million decrease was attributable to a $1.5 million decrease in interest income on our portfolio of marketable securities due to both lower interest rates and a lower average investment balance during the three months ended March 31, 2025 with the utilization of cash from investment maturities supporting our ongoing operating cash needs.
Removed paragraphs (11)

Previous report

In July 2023, we announced topline results from our INTERCEPT-AD clinical trial, which demonstrated that sabirnetug met the primary and secondary objectives of the study in 62 participants with early AD. Sabirnetug was well-tolerated throughout the single ascending dose, or SAD, and multiple ascending dose, or MAD, cohorts, with an overall rate of amyloid-related imaging abnormalities, or ARIA-E, of 10.4%. The incidence of ARIA-E was dose dependent, with a rate of 7% for patients given 10 mg/kg or 25 mg/kg and 21% for patients given 60 mg/kg. An analysis of change in amyloid plaque load, as measured in Centiloids by positron emission tomography, or PET, demonstrated a rapid, dose-related mean decrease at the higher dose levels studied. Statistically significant, dose-related central target engagement was observed as measured by sabirnetug-AßO complex, establishing the first target engagement assay developed that is specific to an AßO-targeting antibody. The study also demonstrated near maximal target engagement for patients receiving 25 mg/kg every two weeks or 60 mg/kg every four weeks, an important finding for dose selection in the ALTITUDE-AD clinical trial. In November 2023, we announced a number of downstream biomarkers in cerebrospinal fluid, or CSF, specific to amyloid and tau pathology and synaptic injury showed improvement in the INTERCEPT-AD MAD cohorts, further supporting a drug effect of sabirnetug on Alzheimer’s pathology. These included effects of sabirnetug on p-tau181, which reflects damage to neurons and is known to be elevated in CSF of patients with AD, and effects of sabirnetug on neurogranin and VAMP2, markers which reflect damage to neuronal synapses and are elevated in CSF of patients with AD.

Previous report

In November 2023, we announced a global collaboration and license agreement with Halozyme, Inc., or Halozyme, to develop a subcutaneous formulation of sabirnetug. In July 2024, we announced that the first subject had been dosed with a subcutaneous formulation of sabirnetug in a Phase 1 PK comparison clinical trial. The clinical trial plans to compare the PK between subcutaneous and intravenous administrations of sabirnetug in healthy volunteers. Topline results from this study are expected in the first quarter of 2025.

Previous report

Research and development expenses were $27.2 million and $11.2 million for the three months ended September 30, 2024 and 2023, respectively. The$16.0 million increase was primarily due to a $13.4 million increase in costs associated with our Phase 2 ALTITUDE-AD clinical trial, for which we announced the dosing of the first patient in May 2024. Additionally, we incurred a $3.1 million increase in license expenses, $1.5 million for higher personnel costs, which included a $0.4 million increase for non-cash stock compensation expenses, as well as an increase of $0.4 million for shipping and packaging of our drug products. These increases were partially offset by decreases of $1.4 million for manufacturing and materials costs and $1.0 million for other contract research expenses.

Previous report

General and administrative expenses were $5.0 million and $4.9 million for the three months ended September 30, 2024 and 2023, respectively. The$0.1 million increase was primarily due to an increase of $0.5 million in personnel expenses, including a $0.3 million increase for non-cash stock compensation expenses, partially offset by decreases of $0.2 million for legal expenses and $0.2 million for consulting expenses.

Previous report

Other income was $2.5 million and $3.1 million for the three months ended September 30, 2024 and 2023, respectively. The$0.6 million decrease was due to an increase in interest expense of$1.0 million related to our borrowings of $30.0 million upon the closing of our Loan Agreement in November 2023, which was partially offset by a $0.4 million increase in interest income due to both higher interest rates and increased investment in marketable securities following our July 2023 underwritten public offering, or the Offering, which raised net proceeds of $121.9 million.

Previous report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Previous report

General and administrative expenses were $15.2 million and $13.6 million for the nine months ended September 30, 2024 and 2023, respectively. The$1.6 million increase was primarily due to an increase of $2.1 million in personnel costs, including a $1.5 million increase for non-cash stock compensation expenses, which were partially offset by a decrease of $0.5 million for consulting expenses.

Previous report

Other income was $9.2 million and $6.8 million for the nine months ended September 30, 2024 and 2023, respectively. The$2.4 million increase was primarily attributable to a $4.5 million increase in interest income on our portfolio of marketable securities due to both higher interest rates and increased investment in marketable securities following the completion of the Offering, which raised net proceeds of $121.9 million, and our borrowings of $30.0 million upon the closing of our Loan Agreement in November 2023, as well as increased income of $1.0 million due to a decrease in the fair value of the embedded derivatives that are bifurcated from the term loan under the Loan Agreement. The increased income was partially offset by an increase in interest expense of $3.0 million related to our Loan Agreement.

Previous report

September 30, 2023. Working capital changes offset the adjusted net loss, providing $5.6 million of cash for operating activities, which included an increase in cash provided by accrued clinical trial expenses of $9.3 million due to our Phase 2 ALTITUDE-AD clinical trial, as well as an increase in accounts payable of $1.3 million. These increases were partially offset by increases in cash used for prepaid expenses and other current assets of $3.8 million and accrued expenses and other current liabilities of $1.2 million.
Reworded paragraphs (24)

Previous wording

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. 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. Our scientific founders pioneered research on soluble amyloid-beta oligomers, or AßOs, which are globular assemblies of the amyloid-beta, or Aß, peptide that are distinct from Aß monomers and amyloid plaques. 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 (ACU193), in our Phase 2 ALTITUDE-AD clinical trial following the results of INTERCEPT-AD, our Phase 1 clinical trial of sabirnetug in “early AD” patients (patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease), which were first 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 previously demonstrated in vivo safety and pharmacologic activity in multiple animal species, including transgenic mouse models for AD.

Current wording

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. 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. Our scientific founders pioneered research on soluble amyloid-beta oligomers, or AßOs, which are globular assemblies of the amyloid-beta, or Aß, peptide that are distinct from Aß monomers and amyloid plaques. 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.

Previous wording

We announced the dosing of the first patient in our Phase 2 ALTITUDE-AD clinical trial in May 2024, and we expect to complete enrollment in the first half of 2025. ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three-arm study designed to evaluate the clinical efficacy and safety of sabirnetug with approximately 180 participants per arm for a total of approximately 540 participants with mild cognitive impairment or mild dementia due to AD. We intend to use the Integrated Alzheimer’s Disease Rating Scale, or iADRS, at 18 months as the primary outcome measure. Our planned doses for ALTITUDE-AD are 35 mg/kg and 50 mg/kg, both dosed every four weeks, or Q4W. These dose levels and frequency were selected based on extensive pharmacokinetic, or PK, and pharmacodynamic, or PD, modeling of our Phase 1 data. Based on regulatory feedback from the European Medicines Agency, or EMA, and to enhance the probability that the EMA will consider ALTITUDE-AD as a registration-eligible study for sabirnetug, we have amended the ALTITUDE-AD clinical trial protocol from a Phase 2/3 study to a Phase 2 standalone study.

Current wording

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 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.

Previous wording

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. The Loan Agreement provides us with a term loan facility in the aggregate principal amount of up to $50 million, of which we have borrowed $30 million in the first tranche and which was funded upon closing. The remaining $20 million is available for borrowing upon our request, subject to review by the lenders of certain information from us and discretionary approval by the lenders. 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.

Current wording

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. The Loan Agreement provides us with a term loan facility in the aggregate principal amount of up to $50.0 million, of which we have borrowed $30.0 million in the first tranche and which was funded upon closing. The remaining $20.0 million is available for borrowing upon our request, subject to review by the lenders of certain information from us and discretionary approval by the lenders. 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.

Previous wording

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

Current wording

During the three months ended March 31, 2025, no shares of 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 the ATM, for net proceeds of $7.9 million, or $3.84 per share.

Previous wording

We have incurred net losses and negative cash flows from operations since our inception. Our net losses were $65.2 million and $35.9 million for the nine months ended September 30, 2024 and 2023, respectively. Approximately $59.2 million, or 91%, of the net loss for the nine months ended September 30, 2024 was due to research and development spending. As of September 30, 2024, we had an accumulated deficit of $288.0 million and working capital of $187.7 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. 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, sales, manufacturing and distribution. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

Current wording

We have incurred net losses and negative cash flows from operations since our inception. Our net losses were $28.8 million and $14.9 million for the three months ended March 31, 2025 and 2024, respectively. Approximately $25.3 million, or 88%, of the net loss for the three months ended March 31, 2025 was due to research and development spending. As of March 31, 2025, we had an accumulated deficit of $353.9 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 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. Should we seek to commercialize our products at our own expense, we would incur significant additional expenses for marketing, sales, manufacturing and distribution. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

Previous wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. 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, fluctuations in inflation and supply disruptions, the ongoing conflicts between Russia and Ukraine and Israel and Hamas 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. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or future commercialization efforts. 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.

Current wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. 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, tariff policy and geopolitical tensions between the United States and foreign countries, rising inflation and supply disruptions, the ongoing conflicts between Russia and Ukraine and Israel and Hamas 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. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or future commercialization efforts. 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.

Previous wording

As of September 30, 2024, we had cash and cash equivalents andmarketable securities totaling $258.9 million, which amount includes the first tranche of $30.0 million that we received under the Loan Agreement with K2HV. 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 oper ating 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.”

Current wording

As of March 31, 2025, we had cash and cash equivalents andmarketable securities of $197.9 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 oper ating expenses and capital expenditure requirements into early 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.”

Previous wording

Research and development costs primarily consist of direct costs associated with consultants and materials, biologic storage, third-party contract research organization, or CRO, costs and contract manufacturing organization, or CMO, expenses, and salaries and other personnel-related expenses. Research and development costs are expensed as incurred. More specifically, these costs include:

Current wording

Research and development costs primarily consist of direct costs associated with consultants and materials, biologic shipping and storage, third-party contract research organizations, or CROs, and contract manufacturing organizations, or

Previous wording

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

Current wording

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

Previous wording

As we currently only have one product candidate, sabirnetug, in development, we do not separately track expenses by program. Further, we have historically relied primarily on consultants for research and development activities; our internal research and development personnel costs currently represent approximately 18% of our total research and development expenses. Our research and development expenses increased substantially since initiating the clinical trial program for sabirnetug in 2021. We expect that our research and development expenses will continue to increase substantially in connection with our continued clinical development activities for sabirnetug.

Current wording

As we currently only have one product candidate, sabirnetug, in development, we do not separately track expenses by program. Further, we have historically relied primarily on consultants for research and development activities; our internal research and development personnel costs currently represent approximately 17% of our total research and development expenses. Our research and development expenses increased substantially since initiating the clinical trial program for sabirnetug in 2021. We expect that our research and development expenses will continue to increase substantially in connection with our continued clinical development activities for sabirnetug.

Previous wording

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, accounting, auditing, taxes, patent services, investor and public relations, board of directors expenses, information technology, franchise taxes, rent, travel expenses and subscriptions.

Current wording

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, board of directors’ expenses, information technology, franchise taxes, rent, travel expenses and subscriptions.

Previous wording

We expect that our general and administrative expenses will increase as our organization and headcount needed in the future grow to support continued research and development activities and potential commercialization of our product candidate. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, attorneys and accountants, among other expenses. Additionally, we expect to continue to incur significant expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission, or SEC, requirements, director and officer insurance costs, and investor and public relations costs.

Current wording

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. 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. Additionally, we expect to continue to incur significant expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission, or SEC, requirements, director and officer insurance costs, and investor and public relations costs.

Previous wording

Other income (expense) primarily includes interest income, interest expense, change in fair value of embedded derivatives and other income (expense), net. The interest income earned, as well as amortization and accretion of premiums and discounts, related to our investments in marketable securities are recorded in interest income. Interest expense primarily 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, accounted for as a derivative at fair value and remeasured at each reporting period for the term of the loan. Other income (expense), net, generally consists of fees incurred on our investments in marketable securities and losses on transactions in foreign currencies, partially offset by either realized gains on marketable securities or sublease income.

Current wording

Other income (expense) includes interest income, interest expense, change in fair value of embedded derivatives and other expense, net. Interest income consists of interest income earned, as well as amortization and accretion of premiums and discounts, related to our investments in marketable securities. 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 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.

Previous wording

Research and development expenses were $59.2 million and $29.0 million for the nine months ended September 30, 2024 and 2023, respectively. The $30.2 million increase in research and development expenses was prim arily due to a $20.9 million increase in costs associated with our Phase 2 ALTITUDE-AD clinical trial, for which we announced the dosing of the first patient in May 2024. Additionally, we incurred a $4.6 million increase in license expenses, $4.1 million for higher personnel costs, which included a $1.2 million increase for non-cash stock compensation expenses, as well as increases in the following: $0.9 million for shipping and packaging of our drug products, $0.8 million related to services provided by research and development contractors and consultants and $0.4 million for conferences and travel expenses. These increases were partially offset by decreases of $1.3 million for manufacturing and materials costs and $0.2 million for other contract research expenses.

Current wording

Research and development expenses were $25.3 million and $12.4 million for the three months ended March 31, 2025 and 2024, respectively. The $12.9 million increase was prim arily due to $7.0 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 a $4.7 million increase for manufacturing and materials, a $0.9 million increase for personnel costs, a $0.4 million increase for other research projects and a $0.3 million increase for storage, shipping and packaging costs. These increases were partially offset by a decrease of $0.4 million related to services provided by research and development consultants and contractors.

Previous wording

Our operations have been financed primarily by net proceeds from the sale and issuance of our common stock and convertible preferred stock, 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.

Current wording

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 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.

Previous wording

We have a sales agreement, or, as amended, the Sales Agreement, with BofA Securities, Inc., Stifel, Nicolaus & Company, Incorporated and BTIG, LLC 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 at-the-market offering program, or ATM, which is included in the $200.0 million of securities that were registered for sale pursuant to a registration statement on Form S-3 filed in 2022. Pursuant to the 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. We are not obligated to make any sales of shares of our common stock under the ATM.

Current wording

We have a sales agreement, or, as amended, the Sales Agreement, with BofA Securities, Inc., Stifel, Nicolaus & Company, Incorporated and BTIG, LLC 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 is included in the $200.0 million of securities that were registered for sale pursuant to a registration statement on Form S-3 filed in 2022. Pursuant to the 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. We are not obligated to make any sales of shares of our common stock under the ATM.

Previous wording

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.

Current wording

During the three months ended March 31, 2025, no shares of common stock were issued under our 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.

Previous wording

As of September 30, 2024, we had cash and cash equivalents andmarketable securities totaling $258.9 million, which amount includes the first tranche of $30.0 million that we received under the Loan Agreement with K2HV. Ouravailable-for-sale marketable securities mature within 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. 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.

Current wording

As of March 31, 2025, we had cash and cash equivalents andmarketable securities totaling $197.9 million. Ouravailable-for-sale marketable securities mature within 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 early 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.

Previous wording

Net cash used in operating activities increased by $24.2 million to $59.0 million for the nine months ended September 30, 2024 from $34.8 million for the nine months ended September 30, 2023. The primary reason for this was an increase in net loss of $29.3 million for the nine months ended September 30, 2024. When adjusted for increases in non-cash expenses including stock-based compensation of $2.8 million, non-cash interest of $0.8 million and other non-cash expense of $0.2 million, which were offset by increases in non-cash income for amortization and accretion on marketable securities of $3.3 million and change in fair value of embedded derivatives of $1.0 million, our net loss for the nine months ended September 30, 2024 was responsible for a $29.8 million increase in cash used as compared to the nine months ended

Current wording

Net cash used in operating activities increased by $16.2 million to $34.1 million for the three months ended March 31, 2025 from $17.9 million for the three months ended March 31, 2024. The$13.9 million increase in our net loss for the three months ended March 31, 2025, adjusted for a decrease in non-cash income for amortization and accretion on marketable securities of $1.2 million partially offset by an increase in the change in fair value of embedded derivatives of $0.2 million, accounted for a $12.9 million increase in cash used in operating activities as compared to the three months ended March 31, 2024. Working capital changes contributed $3.3 million of additional cash used in operations, including cash used for accounts payable and accrued clinical trial expenses of $6.3 million and $1.8 million, respectively, which were partially offset by cash provided from accrued expenses and other liabilities of $3.6 million and $1.2 million from prepaid expenses and other current assets.

Previous wording

Cash provided by investing activities during the nine months ended September 30, 2024 of $18.4 million increased by $141.2 million from cash used in investing activities of $122.9 million during the nine months ended September 30, 2023, primarily due to increases in proceeds from maturities of marketable securities of $118.0 million, net of purc hases of marketable securities of $23.2 million.

Current wording

Cash provided by investing activities during the three months ended March 31, 2025 of $28.7 million increased by $37.9 million from cash used in investing activities of $9.2 million during the three months ended March 31, 2024, primarily due to increases in proceeds from maturities of marketable securities of $27.7 million, and decreases in purchases of marketable securities of $10.2 million.

Previous wording

Cash provided by financing activities during the nine months ended September 30, 2024 of $6.9 million decreased by $115.7 million from cash provided by financing activities of $122.6 million during the nine months ended September 30, 2023, primarily due to net proceeds of $122.3 million from the Offering during the nine months ended September 30, 2023 as compared to $7.9 million of net proceeds from the issuance of common stock under our ATM during the nine months ended September 30, 2024. Additionally, during the nine months ended September 30, 2024, we used cash of $0.7 million as payment under a finance lease agreement for certain computer equipment for our Phase 2 ALTITUDE-AD clinical trial.

Current wording

Cash provided by financing activities during the three months ended March 31, 2025 was immaterial and decreased by $7.1 million from cash provided by financing activities of $7.1 million during the three months ended March 31, 2024. Cash provided by financing activities during the three months ended March 31, 2024 was primarilydue 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.

Previous wording

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, conduct clinical trials and seek marketing approval for our current and any of our future product candidates. 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. 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. 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.

Current wording

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, conduct clinical trials and seek marketing approval for our current and any of our future product candidates. Furthermore, we expect to 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. 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. 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.

Previous wording

•the requirements of the U.S. Food and Drug Administration, or the FDA, EMA and comparable foreign regulatory authorities for clinical trials and nonclinical studies and other work, for review and approval of sabirnetug for AD;

Current wording

•the requirements of the U.S. Food and Drug Administration, or the FDA, and European Medicines Agency, or EMA, and comparable foreign regulatory authorities for clinical trials and nonclinical studies and other work, for review and approval of sabirnetug for AD;

Previous wording

Additional funding may not be available to us on acceptable terms or at all. Any such funding may result in dilution to stockholders, imposition of debt covenants and repayment obligations or other restrictions that may affect our business. We also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us. 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. Additionally, escalation in interest rates, in conjunction with banking failures, may lead to financial institutions being more prudent with capital deployment and tightening lending. If we are unable to raise sufficient additional capital on a timely basis, we could be forced to curtail our planned operations and the pursuit of our business strategy, which would have a material adverse effect on the value of our common stock.

Current wording

Additional funding may not be available to us on acceptable terms or at all. Any such funding may result in dilution to stockholders, imposition of debt covenants and repayment obligations or other restrictions that may affect our business. We also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us. 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 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. If we are unable to raise sufficient additional capital on a timely basis, we could be forced to curtail our planned operations and the pursuit of our business strategy, which would have a material adverse effect on the value of our common stock.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

CMOs, license agreements, salaries and other personnel-related expenses. Research and development costs are expensed as incurred. More specifically, these costs include:
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):