Acumen Pharmaceuticals Inc

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 Phase 2 of our 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 pathology), 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 (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.

Previous wording

We announced the dosing of the first patient in the ALTITUDE-AD clinical trial in May 2024. ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three arm study 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 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 are in the process of amending the ALTITUDE-AD clinical trial protocol, which currently provides for a Phase 2/3 study, to a Phase 2 standalone study. The Company expects to complete enrollment in ALTITUDE-AD in the first half of 2025.

Current 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.

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

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 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.

Previous wording

We have incurred net losses and negative cash flows from operations since our inception. Our net losses were $35.4 million and $22.9 million for the six months ended June 30, 2024 and 2023, respectively. Approximately $32.0 million, or 90%, of the net loss for the six months ended June 30, 2024 was due to research and development spending. As of June 30, 2024, we had an accumulated deficit of $258.2 million and working capital of $251.5 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 $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.

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 U.S. 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, 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.

Previous wording

As of June 30, 2024, we had cash and cash equivalents andmarketable securities totaling $281.4 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 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.”

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 22% 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 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.

Previous wording

Other income (expense) primarily includes interest income, interest expense, change in fair value of embedded derivatives and other 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 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 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 partially offset by sublease income.

Current 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.

Previous wording

Research and development expenses were $19.5 million and $9.1 million for the three months ended June 30, 2024 and 2023, respectively. The $10.4 million increase was primarily due to a $5.9 million increase in CRO costs associated with the ALTITUDE-AD study, for which we announced the dosing of the first patient in May 2024. Additionally, we incurred$1.4 million for higher personnel costs, which included a $0.4 million increase for non-cash stock compensation expenses, as well as increases in the following: $1.6 million for license agreement expenses, $1.0 million for other clinical trial expenses, $0.4 million for shipping and packaging of our drug products and $0.1 million related to services provided by research and development contractors and consultants.

Current wording

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 wording

General and administrative expenses were $4.8 million and $4.3 million for the three months ended June 30, 2024 and 2023, respectively. The $0.5 million increase was primarily due to increases of $0.7 million in personnel expenses, including a $0.5 million increase for non-cash stock compensation expenses, and was partially offset by a decrease of $0.2 million for insurance expense.

Current wording

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 wording

Other income was $3.8 million and $1.9 million for the three months ended June 30, 2024 and 2023, which was primarily related to net interest income on our portfolio of marketable securities. The $1.9 million increase in interest income was due to both higher interest rates and increased investment in marketable securities following our July 2023 underwritten public offering, which raised net proceeds of $121.9 million, or the Offering, and our borrowings of $30.0 million upon the closing of our Loan Agreement in November 2023. Other income also increased $1.1 million due to a decrease in the fair value of the embedded derivatives that are bifurcated from the term loan under the Loan Agreement, and was partially offset by an increase in interest expense of $1.0 million related to our Loan Agreement, as well as a $0.1 million increase in other expense, net.

Current wording

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 wording

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

Current wording

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

Previous wording

Research and development expenses were $32.0 million and $17.8 million for the six months ended June 30, 2024 and 2023, respectively. The $14.2 million increase in research and development expenses was primarily due to a $6.2 million increase in 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$2.6 million for higher personnel costs, which included a $0.8 million increase for non-cash stock compensation expenses, as well as increases in the following: $1.4 million for license agreement expenses, $1.3 million for manufacturing and materials costs, $1.0 million for other clinical trial expenses, $0.9 million related to services provided by research and development contractors and consultants, $0.5 million for shipping and packaging of our drug products and an overall $0.3 million increase in other contract research expenses.

Current 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.

Previous wording

General and administrative expenses were $10.2 million and $8.8 million for the six months ended June 30, 2024 and 2023, respectively. The $1.4 million increase was primarily due to an increase of $1.7 million in personnel costs, including a $1.2 million increase for non-cash stock compensation expenses, which was partially offset by a decrease of $0.3 million for insurance expense.

Current wording

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 wording

Other income was $6.7 million and $3.7 million for the six months ended June 30, 2024 and 2023, respectively. The $3.0 million increase was primarily attributable to a $4.1 million increase in interest income on our portfolio of marketable securities due to both higher interest rates and increased investment in marketable securities following our July 2023 public 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 $1.1 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 $2.0 million related to our Loan Agreement, as well as a $0.1 million increase in other expense, net.

Current wording

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 wording

As of June 30, 2024, we had cash and cash equivalents andmarketable securities totaling $281.4 million. Ouravailable-for-sale marketable securities mature over the next 15 months. 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 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.

Previous wording

Net cash used in operating activities increased by $12.6 million to $34.4 million for the six months ended June 30, 2024 from $21.8 million for the six months ended June 30, 2023. The primary reason for this was an increase in net loss of $12.5 million for the six months ended June 30, 2024. When adjusted for increases in non-cash expenses including stock-based compensation of $2.0 million and non-cash interest of $0.5 million, which were offset by increases in non-cash income for amortization and accretion on marketable securities of $2.6 million and change in fair value of embedded derivatives of $1.0 million, our net loss for the six months ended June 30, 2024 was responsible for a $13.6 million increase in cash used as compared to the six months ended June 30, 2023. Working capital changes offset the adjusted net loss, providing $1.0 million of cash for operating activities, which included an increase in cash provided by accrued clinical trial expenses of

Current 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

Previous wording

$1.3 million due to our ALTITUDE-AD clinical trial, as well as an increase in accounts payable of $2.4 million. These increases were partially offset by increases in cash used for prepaid expenses and other current assets of $1.4 million and accrued expenses and other current liabilities of $1.3 million.

Current wording

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.

Previous wording

Cash provided by investing activities during the six months ended June 30, 2024 of $28.5 million increased by $59.4 million from cash used in investing activities of $30.9 million during the six months ended June 30, 2023, primarily due to increases in maturities of marketable securities of $64.4 million, net of purc hases of marketable securities of $5.0 million.

Current 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.

Previous wording

Cash provided by financing activities during the six months ended June 30, 2024 of $7.0 million increased by $7.1 million from cash used in financing activities of $0.1 million during the six months ended June 30, 2023, primarily due to $7.9 million of net proceeds from the issuance of our common stock under our ATM, which was partially offset by a payment of $0.7 million under a finance lease agreement for certain computer equipment for our ALTITUDE-AD clinical trial and a $0.1 million increase in deferred offering costs related to our 2024 Registration Statement.

Current 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.

Previous wording

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