9 unchanged sentences
Report of Independent Registered Public Accounting Firm
−Removed: To the Shareholders and the Board of Directors of Acumen Pharmaceuticals, Inc.
+Added: To the Stockholders and the Board of Directors of Acumen Pharmaceuticals, Inc.
Opinion on the Financial Statements
18 unchanged sentences
/s/ Ernst & Young LLP
−Removed: We have served as the Company’s auditors since 2021.
−Removed: Tysons, Virginia
+Added: We have served as the Company’s auditor since 2021.
+Added: Philadelphia, Pennsylvania
March 27, 2025
9 unchanged sentences
Restricted cash 232 233
−Removed: Property and equipment, net 122 165
−Removed: Right-of-use asset 381 105
−Removed: Other assets 221 151
+Added: Other assets, long-term 486 724
Total assets $ 238,992 $ 310,125
4 unchanged sentences
Accrued expenses and other current liabilities 6,615 6,449
−Removed: Finance lease liability, short-term 756 —
−Removed: Operating lease liability, short-term 110 105
+Added: Finance lease liability — 756
Total current liabilities 27,607 12,971
−Removed: Operating lease liability, long-term 284 —
Debt, long-term 29,419 29,897
+Added: Other liabilities, long-term 150 284
Total liabilities 57,176 43,152
23 unchanged sentences
Interest income 14,317 10,791
−Removed: Change in fair value of embedded derivatives ( 1,360 ) —
Interest expense ( 4,068 ) ( 581 )
+Added: Change in fair value of embedded derivatives 1,590 ( 1,360 )
Other expense, net ( 151 ) ( 83 )
19 unchanged sentences
16,774,193 2 121,902 — — 121,904
−Removed: Unrealized loss on marketable securities — — — — ( 520 ) ( 520 )
Stock options exercised for cash 111,206 — 325 — — 325
−Removed: Cashless exercise of stock options 4,746 — — — — —
+Added: Issuance of warrant with Term Loan — — 1,132 — — 1,132
+Added: Unrealized gain on marketable securities — — — — 1,063 1,063
Stock-based compensation — — 6,145 — — 6,145
3 unchanged sentences
2,068,246 — 7,938 — — 7,938
−Removed: Stock options exercised for cash 111,206 — 325 — — 325
−Removed: Issuance of warrant with Term Loan — — 1,132 — — 1,132
−Removed: Unrealized gain on marketable securities — — — — 1,063 1,063
+Added: Issuance of common stock for restricted stock units, net of shares withheld for taxes 115,376 — ( 41 ) — — ( 41 )
+Added: Unrealized loss on marketable securities — — — — ( 360 ) ( 360 )
Stock-based compensation — — 9,635 — — 9,635
17 unchanged sentences
Non-cash interest expense 1,118 145
+Added: Other non-cash expense 232 —
Changes in operating assets and liabilities:
Prepaid expenses and other current assets ( 3,656 ) ( 369 )
−Removed: Other assets ( 70 ) ( 137 )
+Added: Other long-term assets 74 ( 70 )
Accounts payable 4,269 ( 261 )
Accrued clinical trial expenses 10,957 1,670
−Removed: Accrued expenses and other current liabilities 2,989 ( 562 )
+Added: Accrued expenses and other liabilities 32 2,879
Finance lease liability ( 23 ) 17
−Removed: Operating lease liability ( 110 ) ( 137 )
Net cash used in operating activities ( 86,215 ) ( 43,064 )
8 unchanged sentences
Proceeds from Term Loan — 30,000
+Added: Payment for financing lease ( 739 ) —
Payments for financing costs — ( 476 )
+Added: Payments for deferred offering costs ( 230 ) —
+Added: Repurchase of common shares to pay employee withholding taxes ( 41 ) —
Proceeds from exercise of stock options — 325
3 unchanged sentences
Cash and cash equivalents and restricted cash at the end of the period $ 35,859 $ 67,119
+Added: ACUMEN PHARMACEUTICALS, INC.
+Added: STATEMENTS OF CASH FLOWS (CONTINUED)
+Added: (in thousands)
+Added: Year Ended December 31,
Supplemental disclosure of cash flow information
15 unchanged sentences
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.
−Removed: The Company is currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug, in clinical development following Phase 1 results in “early AD” patients (patients with mild cognitive impairment or mild dementia due to Alzheimer’s pathology) that were reported in July 2023.
−Removed: Sabirnetug is a recombinant humanized immunoglobulin gamma 2 (“IgG2”) monoclonal antibody (“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.
+Added: The Company is currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug, in its Phase 2 ALTITUDE-AD clinical trial following the results of INTERCEPT-AD, its Phase 1 clinical trial of sabirnetug in “early AD” patients (patients with mild cognitive impairment or mild dementia due to AD), which were first reported in July 2023.
+Added: Sabirnetug is a recombinant humanized immunoglobulin gamma 2 monoclonal antibody 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.
The Company is subject to the uncertainty of whether its intellectual property will develop into successful commercial products.
−Removed: Public Offering
−Removed: On July 21, 2023, the Company issued 16,774,193 shares of its common stock, $ 0.0001 par value per share (“Common Stock”), in a public offering (the “Offering”) at a price of $ 7.75 per share.
−Removed: The aggregate net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $ 121.9 million.
−Removed: See additional discussion in Note 8.
−Removed: Stockholders’ Equity.
Liquidity and Capital Resources
11 unchanged sentences
The Company may be required to delay, limit, reduce or terminate its product discovery and development activities or future commercialization efforts.
−Removed: The Company completed a Phase 1 clinical trial of sabirnetug in the second quarter of 2023, which the Company named “INTERCEPT-AD.” This trial enrolled 65 patients with “early AD” and 62 participants received at least one dose of study drug.
+Added: The Company completed its INTERCEPT-AD clinical trial of sabirnetug in the second quarter of 2023.
+Added: This trial enrolled 65 patients with early AD and 62 participants received at least one dose of study drug.
INTERCEPT-AD was a U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial with overlapping single ascending dose and multiple ascending dose cohorts evaluating patients with early AD.
−Removed: In July 2023, the
−Removed: Company announced topline results from INTERCEPT-AD, which demonstrated that sabirnetug met the primary and secondary objectives of this study in 62 participants with early AD .
−Removed: The Company expects to initiate a Phase 2 clinical trial of sabirnetug called “ALTITUDE-AD” in the first half of 2024.
+Added: In July 2023, the Company 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 .
+Added: The Company announced the dosing of the first patient in its Phase 2 ALTITUDE-AD clinical trial in May 2024 and completed enrollment in March 2025.
BASIS OF PRESENTATION, SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND RECENT ACCOUNTING PRONOUNCEMENTS
4 unchanged sentences
In the opinion of management, all adjustments (consisting of normal recurring adjustments) have been made that are necessary to present fairly the Company’s financial position, and the results of its operations and its cash flows.
+Added: Reclassifications
+Added: The Company has made certain reclassifications to prior period amounts to conform to the current period presentation within the accompanying financial statements and notes to the financial statements.
+Added: On the balance sheet, property and equipment, net, and right-of-use asset are presented within other assets, whereas they were previously presented as separate line items.
+Added: Similarly, operating lease liability, short-term, and operating lease liability, long-term are now presented within accrued expenses and other current liabilities, and other liabilities, long-term, respectively, rather than as separate line items.
+Added: Additionally, on the statement of cash flows, operating lease liability is presented within accrued expenses and other liabilities instead of as a separate line item.
Emerging Growth Company
20 unchanged sentences
Marketable Securities
−Removed: The Company’s marketable securities portfolio consists primarily of investments in money market funds, asset-backed securities, U.S.
+Added: The Company’s marketable securities portfolio consists primarily of investments in money market funds, U.S.
treasury and agency securities and short-term highly liquid, high credit quality corporate debt securities.
16 unchanged sentences
The Company has made the accounting policy election to exclude accrued interest receivable on securities from the estimate of credit losses and will record a credit loss expense for accrued interest receivable in the period when a credit loss is recorded for the related securities.
−Removed: Management determined that t he Company did not require an allowance for credit losses for available-for-sale securities as of December 31, 2023 or 2022, as only a small number of investments had a present value of cash flows expected to be collected in excess of the amortized cost, and the aggregate amount of this credit loss was immaterial.
+Added: Management determined that t he Company did not require an allowance for credit losses for available-for-sale securities as of December 31, 2024 or 2023, as the aggregate amount of any credit losses was immaterial.
The Company did not have any related write-offs or recoveries for the years ended December 31, 2024 and 2023.
24 unchanged sentences
three years for computer-related assets and five years for furniture.
−Removed: Leases for additional discussion regarding our finance lease for computer equipment .
+Added: Supplemental Financial Information.
The Company accounts for its leases under ASC 842, Leases .
9 unchanged sentences
For short-term leases, the Company recognized lease payments on a straight-line basis over the lease term.
+Added: Computer Equipment Lease
+Added: In September 2023, the Company entered into an agreement with a vendor that included the lease of certain computer equipment for its Phase 2 clinical trial with an October 2023 lease commencement date.
+Added: In January 2024, the Company paid $ 0.8 million for the computer equipment, which will be returned to the vendor at the completion of the vendor’s services under the agreement.
+Added: Upon the lease inception, the Company recorded non-cash expense of $ 0.7 million in research and development expense in the statement of operations and comprehensive loss for the right-of-use assets related to the computer equipment lease as the equipment is being used for research and development and does not have an alternative future use.
Debt Discount and Debt Issuance Costs
22 unchanged sentences
The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant date fair value of the awards and actual forfeitures.
−Removed: The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, which requires the use of a number of complex assumptions including the fair value of the Common Stock, expected volatility, risk-free interest rate, expected dividends, and the expected term of the option.
+Added: The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, which requires the use of a number of complex assumptions including expected volatility, risk-free interest rate, expected dividends, and the expected term of the option.
The fair value of restricted stock units (“RSUs”) is the closing market price of the common stock on the date of the grant.
3 unchanged sentences
Forfeitures are recorded as they occur.
−Removed: See also Note 9.
−Removed: Stock-based Compensation below.
+Added: Stock-based Compensation.
Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach.
12 unchanged sentences
Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period.
−Removed: Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, stock options, restricted stock units and warrants, which would result in the issuance of incremental shares of common stock.
+Added: Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, stock options, RSUs and warrants, which would result in the issuance of incremental shares of common stock.
However, potential shares of common stock are excluded if their effect is anti-dilutive.
For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.
−Removed: For the year ended December 31, 2023, potential common shares consisted of stock options, restricted stock units, convertible debt and a warrant to purchase Common Stock.
−Removed: For the year ended December 31, 2022, potential shares of common stock consisted of stock options.
+Added: For the years ended December 31, 2024 and 2023, potential common shares consisted of stock options, RSUs, convertible debt and a warrant to purchase common stock.
Potentially dilutive securities not included in the calculation of diluted net loss per share of common stock as of the periods presented, because to do so would be anti-dilutive, were as follows:
5 unchanged sentences
Segment Information
−Removed: Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
−Removed: The Company views its operations and manages its business in one segment.
+Added: Operating segments are defined as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance.
+Added: The Company’s CODM is its chief executive officer.
+Added: The Company has one operating segment focused on the research and development of sabirnetug for the treatment of patients with AD.
+Added: See Note 10 – Segments.
Recently Adopted Accounting Pronouncements
−Removed: In June 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments-Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments , which was codified with its subsequent amendments as ASC 326.
−Removed: ASC 326 seeks to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments, including trade receivables, and other commitments to extend credit held by a reporting entity at each reporting date.
−Removed: The amendments require an entity to replace the incurred loss impairment methodology in current U.S.
−Removed: GAAP with a methodology that reflects current expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates.
+Added: In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures.
+Added: The standard is intended to improve financing reporting by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors to develop more decision-useful financial analyses.
+Added: The standard is effective for fiscal years beginning after December 31, 2023, and interim periods within fiscal years beginning after December 15, 2024 and must be applied retrospectively to all prior periods presented in the financial statements.
The Company adopted this guidance on January 1, 2024.
−Removed: The Company’s marketable securities portfolio consists entirely of available-for-sale debt securities and, as such, the adoption of this guidance did not have a material impact on its financial statements and disclosures upon adoption, but it did require the Company to provide additional disclosures related to its available-for-sale debt securities in a continuous unrealized loss position.
−Removed: In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), to address the complexity associated with applying U.S.
−Removed: GAAP to certain financial instruments with characteristics of liabilities and equity.
−Removed: ASU 2020-06 includes amendments to the guidance on convertible instruments and the derivative scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments, which include beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20.
−Removed: Additionally, ASU 2020-06 requires entities to use the “if-converted” method when calculating diluted earnings per share for convertible instruments.
−Removed: The Company early adopted this guidance on January 1, 2023, with no impact to the financial statements or results of operations of the Company.
+Added: The adoption of this guidance did not have a material impact on its financial statements and disclosures upon adoption;
+Added: but it did require the Company to provide additional disclosures regarding segments.
+Added: Recently Issued Accounting Pronouncements
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: The standard is intended to enhance the existing income tax disclosures to provide information to better assess how an entity’s operations and related tax risks and tax planning and operational opportunities affect its tax rate and prospects for future cash flows.
+Added: The standard is effective for annual periods beginning after December 15, 2024.
+Added: Upon adoption, the standard should be applied on a prospective basis, although retrospective application is permitted.
+Added: Early adoption is also permitted.
+Added: The Company is evaluating the potential impact of this adoption on the financial statements and related disclosures.
+Added: In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses.
+Added: The standard is intended to require more detailed disclosures about specified categories of expenses, including employee compensation, depreciation and amortization, included in certain expense captions presented on the face of the income statement.
+Added: The ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 31, 2027.
+Added: Early adoption is permitted.
+Added: The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements.
+Added: The Company is evaluating the potential impact of this adoption on the financial statements and related disclosures.
+Added: In November 2024, the FASB issued ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470- 20):
+Added: Induced Conversions of Convertible Debt Instruments.
+Added: The standard is intended to clarify the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion.
+Added: The standard is effective for annual periods beginning after December 15, 2025, and for interim periods within those annual reporting periods.
+Added: Early adoption is permitted if ASU 2020-06 has been adopted.
+Added: Upon adoption, the standard may be applied on a prospective or retrospective basis.
+Added: The Company is evaluating the potential impact of this adoption on the financial statements and related disclosures.
MARKETABLE SECURITIES
9 unchanged sentences
Corporate debt securities 60,171 — ( 203 ) 59,968
−Removed: Government and agency - U.S.
−Removed: 4,985 23 — 5,008
Total available-for-sale securities, long-term 60,171 — ( 203 ) 59,968
6 unchanged sentences
securities 32,470 82 ( 6 ) 32,546
−Removed: Asset-backed securities 3,006 — ( 102 ) 2,904
Total available-for-sale securities, short-term 176,654 179 ( 197 ) 176,636
1 unchanged sentence
Corporate debt securities 57,240 320 ( 15 ) 57,545
+Added: Government and agency - U.S.
+Added: securities 4,985 23 — 5,008
Total available-for-sale securities, long-term 62,225 343 ( 15 ) 62,553
6 unchanged sentences
Corporate debt securities $ 73,952 $ ( 211 ) $ 2,515 $ — $ 76,467 $ ( 211 )
−Removed: Government and agency - U.S.
−Removed: securities 5,585 ( 6 ) — — 5,585 ( 6 )
Total $ 73,952 $ ( 211 ) $ 2,515 $ — $ 76,467 $ ( 211 )
3 unchanged sentences
Corporate debt securities $ 78,995 $ ( 152 ) $ 12,074 $ ( 54 ) $ 91,069 $ ( 206 )
−Removed: Asset-backed securities — — 2,904 ( 102 ) 2,904 ( 102 )
Government and agency - U.S.
2 unchanged sentences
As of December 31, 2024, the Company’s available-for-sale securities classified as short-term mature in one year or less and the Company’s available-for-sale securities classified as long-term mature within two years .
−Removed: As noted in the table above, although some of the Company’s available-for-sale marketable securities as of December 31, 2023 have been in an unrealized loss position for more than 12 months, the Company does not intend to sell these securities and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
+Added: As noted in the table above, although one of the Company’s available-for-sale marketable securities with a fair value of $ 2.5 million has been in an unrealized loss position for more than 12 months as of December 31, 2024, the loss is immaterial and the Company does not intend to sell any of its available-for-sale securities and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
No credit losses were recognized on the Company’s available-for-sale securities during the years ended December 31, 2024 and 2023.
−Removed: The Company recorded an immaterial realized gain during the year ended December 31, 2023 and had no realized gains or losses during the year ended December 31, 2022.
+Added: The Company recorded a realized gain of approximately $ 0.1 million during the year ended December 31, 2024 and recorded an immaterial realized gain during the year ended December 31, 2023.
FAIR VALUE MEASUREMENTS
The Company’s financial assets and liabilities subject to fair value measurement on a recurring basis and the level of inputs used for such measurements were as follows (in thousands):
−Removed: Fair value measurements at reporting date using
+Added: Fair value measurements as of December 31, 2024 using
Quoted Prices in
3 unchanged sentences
Inputs (Level 2) Significant
−Removed: (Level 3) Fair Value at
+Added: (Level 3) Fair Value as of
Assets included in:
3 unchanged sentences
Corporate debt securities — 178,901 — 178,901
−Removed: treasury securities — 37,554 — 37,554
+Added: Government and agency - U.S.
+Added: — 16,997 — 16,997
Total fair value $ 35,268 $ 195,898 $ — $ 231,166
3 unchanged sentences
Total fair value $ — $ — $ 970 $ 970
−Removed: Fair value measurements at reporting date using
+Added: Fair value measurements as of December 31, 2023 using
Quoted Prices in
3 unchanged sentences
Inputs (Level 2) Significant
−Removed: (Level 3) Fair Value at
+Added: (Level 3) Fair Value as of
Assets included in:
3 unchanged sentences
Corporate debt securities — 201,635 — 201,635
−Removed: Asset-backed securities — 2,904 — 2,904
Government and agency - U.S.
1 unchanged sentence
Total fair value $ 66,207 $ 239,189 $ — $ 305,396
+Added: Liabilities included in:
+Added: Debt, long-term
+Added: Embedded derivative liabilities $ — $ — $ 2,560 $ 2,560
+Added: Total fair value $ — $ — $ 2,560 $ 2,560
The fair value of the Company’s money market funds is determined using quoted market prices in active markets for identical assets.
The fair value for the available-for-sale marketable securities is determined based on valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curve, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, broker and dealer quotes, as well as other relevant economic measures.
−Removed: The following table presents changes in Level 3 liabilities measured at fair value for the year ended December 31, 2023 (in thousands):
+Added: The following table presents changes in Level 3 liabilities measured at fair value for the two-year period ended December 31, 2024 (in thousands):
Balance, January 1, 2023 $ —
2 unchanged sentences
Balance, December 31, 2023 2,560
−Removed: For the year ended December 31, 2023, the fair value of the embedded derivatives in the Term Loan has been estimated using the Monte Carlo model.
−Removed: A summary of the weighted-average significant unobservable inputs (Level 3 inputs) used in measuring the embedded derivatives in the Term Loan as of December 31, 2023 and November 10, 2023 (inception) is as follows:
+Added: Change in fair value of embedded derivatives ( 1,590 )
+Added: Balance, December 31, 2024 $ 970
+Added: During the years ended December 31, 2024 and 2023, the fair value of the embedded derivatives in the Term Loan has been estimated using the Monte Carlo model.
+Added: A summary of the weighted-average significant unobservable inputs (Level 3 inputs) used in measuring the embedded derivatives in the Term Loan as of December 31, 2024 and 2023 and November 10, 2023 (inception) is as follows:
December 31, November 10,
+Added: 2024 2023 2023
Conversion price $ 2.53 $ 2.53 $ 2.53
5 unchanged sentences
SUPPLEMENTAL FINANCIAL INFORMATION
−Removed: Prepaid expenses and other current assets consisted of the following (in thousands):
+Added: Prepaid expenses and other assets as of December 31, 2024 and 2023 consisted of the following (in thousands):
+Added: December 31, 2024
+Added: Prepaid Expenses and Other Current Assets Other Long-Term Assets Total Prepaid Expenses and Other Assets
Research and development service agreements $ 4,841 $ 75 $ 4,916
Prepaid insurance 858 — 858
+Added: Other receivables 345 — 345
+Added: Dues and subscriptions 230 — 230
+Added: Prepaid raw materials 159 9 168
Interest receivable 53 — 53
+Added: Right-of-use asset — 266 266
+Added: Property and equipment, net (1) — 73 73
+Added: Other 263 63 326
+Added: Total $ 6,749 $ 486 $ 7,235
+Added: December 31, 2023
+Added: Prepaid Expenses and Other Current Assets Other Long-Term Assets Total Prepaid Expenses and Other Assets
+Added: Research and development service agreements $ 1,680 $ 169 $ 1,849
+Added: Prepaid insurance 807 — 807
+Added: Interest receivable 225 — 225
Dues and subscriptions 175 — 175
Prepaid raw materials 98 42 140
+Added: Right-of-use asset — 381 381
+Added: Property and equipment, net (1) — 122 122
Other 108 10 118
−Removed: Total prepaid expenses and other current assets $ 3,093 $ 2,724
−Removed: Accrued expenses and other current liabilities consisted of the following (in thousands):
+Added: Total $ 3,093 $ 724 $ 3,817
+Added: (1) As of both December 31, 2024 and 2023, accumulated depreciation totaled approximately $ 0.1 million.
+Added: Accrued expenses and other liabilities as of December 31, 2024 and 2023 consisted of the following (in thousands):
+Added: December 31, 2024
+Added: Accrued Expenses and Other Current Liabilities Other Long-Term Liabilities Total Accrued Expenses and Other Liabilities
Compensation and other employee liabilities $ 4,207 $ — $ 4,207
1 unchanged sentence
Interest 249 — 249
+Added: Operating lease liability 133 150 283
Other 230 — 230
−Removed: Total accrued expenses and other current liabilities $ 6,339 $ 3,350
+Added: Total $ 6,615 $ 150 $ 6,765
+Added: December 31, 2023
+Added: Accrued Expenses and Other Current Liabilities Other Long-Term Liabilities Total Accrued Expenses and Other Liabilities
+Added: Compensation and other employee liabilities $ 3,692 $ — $ 3,692
+Added: Research and development 2,186 — 2,186
+Added: Interest 249 — 249
+Added: Operating lease liability 110 284 394
+Added: Other 212 — 212
+Added: Total $ 6,449 $ 284 $ 6,733
On November 10, 2023, the Company entered into a Loan and Security Agreement with K2 HealthVentures LLC (the “Loan Agreement”).
1 unchanged sentence
The remaining $ 20.0 million is available for borrowing upon the Company’s request based on review of certain information and discretionary approval from the lenders.
−Removed: The Loan Agreement bears interest per annum at the greater of 9.65 % or the sum of the prime rate last quoted in The Wall Street Journal plus 1.15 % for such interest period and the principal amount of Term Loan outstanding under the Loan Agreement.
+Added: The principal amount of the Term Loan outstanding under the Loan Agreement bears interest per annum at the greater of (i) 9.65 % or (ii) the sum of the prime rate last quoted in The Wall Street Journal plus 1.15 % for such interest period.
The Term Loan matures on November 1, 2027, and can be extended to November 1, 2028 if the Company achieves certain financing milestones.
The Loan Agreement provides for a final payment fee of an additional $ 1.6 million (the “Final Payment”) due upon repayment of the Term Loan.
+Added: As security for its obligations under the Loan Agreement, the Company granted the lenders a security interest in substantially all of the Company’s assets (other than intellectual property).
The principal and interest of the Term Loan are to be repaid in equal monthly installments beginning on July 1, 2026 through the maturity of the Loan Agreement.
The Loan Agreement allows prepayments of the entire Term Loan or a portion of the Term Loan of more than $ 5.0 million, provided that any partial prepayment will leave outstanding borrowings of at least $ 15.0 million.
−Removed: The lenders can elect to convert up to $ 2.5 million of the Term Loan (the “Conversion Amount”) to Common Stock at a conversion price of $ 2.53 (the “Conversion Option”).
+Added: The lenders can elect to convert up to $ 2.5 million of the Term Loan (the “Conversion Amount”) into common stock at a conversion price of $ 2.53 (the “Conversion Option”).
If the lenders elect to convert the Conversion Amount upon the Next Qualified Financing, as defined in the Loan Agreement whereby the Company receives aggregate gross proceeds of at least $ 20.0 million, the conversion price will equal the lowest effective cash price per share of securities issued in such Qualified Financing (the “Share-Settled Redemption”).
5 unchanged sentences
Outstanding debt consisted of the following (in thousands):
−Removed: December 31, 2023
Principal value of Term Loan, including final payment of $ 1,635
+Added: $ 31,635 $ 31,635
Fair value of bifurcated embedded derivatives 970 2,560
2 unchanged sentences
The following table provides the components of interest expense (in thousands):
−Removed: December 31, 2023
+Added: Year Ended December 31,
Interest expense based on the coupon interest rate of the outstanding debt $ 2,943 $ 418
Accretion of debt discount 1,112 145
−Removed: Total interest expense $ 563
−Removed: For the year ended December 31, 2023, the effective interest rate for the Term Loan was 14.3 %.
+Added: Total interest expense related to debt $ 4,055 $ 563
+Added: For both the years ended December 31, 2024 and 2023, the effective interest rate for the Term Loan was 13.5 %.
As of December 31, 2024, the aggregate principal payments due for the Term Loan by year are as follows (in thousands):
2 unchanged sentences
Total principal payment due for Term Loan $ 31,635
−Removed: Office leases
−Removed: On September 11, 2023, the Company entered into a lease for office space in Newton, Massachusetts, with a lease term of approximately 38 months beginning October 20, 2023, and which expires on December 31, 2026.
−Removed: On September 28, 2022, the Company entered into a lease for office space in Charlottesville, Virginia with a lease term of 15 months beginning October 1, 2022.
−Removed: On December 1, 2022, the Company entered into a lease for additional office space in the same building in Charlottesville, Virginia with a lease term of 12 months beginning on January 1, 2023.
−Removed: There is no automatic renewal for either of the Charlottesville, Virginia leases, but the lease agreements provide that any holdover tenancy shall be on a month-to-month basis thereafter.
−Removed: The Company had been subleasing space in Carmel, Indiana since March 1, 2020.
−Removed: The Company executed a new sublease for this space that was effective on February 1, 2021 and expired on August 30, 2023, at which time the Company ceased to occupy this space.
−Removed: The Company allowed others to sublease a portion of the space from the Company for less than a one-year period.
−Removed: The Company recognizes sublease income in other expense, net in the statements of operations and comprehensive Loss.
−Removed: Computer Equipment Lease
−Removed: In September 2023, the Company entered into an agreement with a vendor that included the lease of certain computer equipment for its planned Phase 2 clinical trial with an October 2023 lease commencement date.
−Removed: In January 2024, the Company paid $ 0.8 million for the computer equipment which will be returned to the vendor at the completion of the vendor’s services under the agreement.
−Removed: Upon the lease inception, the Company recorded non-cash expense of $ 0.7 million in research and development expense in the statement of operations and comprehensive loss for the right-of-use assets related to the computer equipment lease as the equipment is being used for R&D and does not have an alternative future use.
−Removed: The following table summarizes quantitative information about the Company’s leases (in thousands):
−Removed: Year Ended December 31,
−Removed: Finance lease
−Removed: Interest lease cost $ 17 $ —
−Removed: Finance lease expense 17 —
−Removed: Operating leases
−Removed: Operating lease cost 133 154
−Removed: sublease income ( 5 ) ( 43 )
−Removed: Operating lease expense 128 111
−Removed: Short-term lease rent expense 15 13
−Removed: Total rent expense $ 160 $ 124
−Removed: Supplemental information related to leases was as follows (dollar amounts in thousands):
−Removed: Year Ended December 31,
−Removed: Operating cash flows from finance lease $ 17 $ —
−Removed: Operating cash flows from operating leases $ 121 $ 154
−Removed: Right-of-use assets obtained in exchange for finance lease liabilities $ 739 $ —
−Removed: Right-of-use assets obtained in exchange for operating lease liabilities $ 399 $ 242
−Removed: Noncash research and development expense for the right-of-use assets (finance lease) $ 739 —
−Removed: Weighted-average remaining lease term – finance leases (in years) 3.8 —
−Removed: Weighted-average remaining lease term – operating leases (in years) 3.0 0.7
−Removed: Weighted-average discount rate – finance leases 9.7 % —
−Removed: Weighted-average discount rate – operating leases 9.7 % 10.0 %
−Removed: As of December 31, 2023, the present value of maturities of the Company’s finance lease liabilities were as follows (in thousands):
−Removed: Year ended December 31, 2024 $ 763
−Removed: present value discount ( 7 )
−Removed: Finance lease liability $ 756
−Removed: As of December 31, 2023, the present value of maturities of the Company’s operating lease liabilities were as follows (in thousands):
−Removed: Year ended December 31, 2024 $ 143
−Removed: Year ended December 31, 2025 155
−Removed: Year ended December 31, 2026 158
−Removed: present value discount ( 63 )
−Removed: Operating lease liability $ 393
STOCKHOLDERS’ EQUITY
Authorized Shares
−Removed: As of December 31, 2023, the total number of shares of capital stock authorized to be issued per the Company’s Amended and Restated Certificate of Incorporation is 310,000,000 , with 10,000,000 shares designated as preferred stock with a par value of $ 0.0001 , and 300,000,000 shares designated as Common Stock.
+Added: As of December 31, 2024, the total number of shares of capital stock authorized to be issued per the Company’s Amended and Restated Certificate of Incorporation is 310,000,000 , with 10,000,000 shares designated as preferred stock with a par value of $ 0.0001 , and 300,000,000 shares designated as common stock, with a par value of $ 0.0001 (“Common Stock”).
Each share of common stock issued and outstanding is entitled to one vote.
8 unchanged sentences
On April 23, 2023, the Company entered into an amendment to the Sales Agreement (as amended, the “Amended Sales Agreement”) to add BTIG, LLC (“BTIG”) as a sales agent under the Amended Sales Agreement (BTIG, together with BofA and Stifel, the “Sales Agents”).
−Removed: Pursuant to the Amended Sales Agreement, the Company will pay the Sales Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of Common Stock.
+Added: Pursuant to the Amended Sales Agreement, the Company will pay the Sales Agents a commission rate of up to 3.0 % of the gross
+Added: proceeds from the sale of any shares of Common Stock under the ATM.
The Company is not obligated to make any sales of shares of its Common Stock under the ATM.
−Removed: The Company did not sell any shares of its Common Stock under the ATM during the year ended December 31, 2023.
−Removed: In October 2022, the Company issued 422,160 shares of common stock under the ATM for net proceeds of $ 3.8 million, at a weighted average price of $ 10.06 per share.
−Removed: See additional discussion in Note 12.
−Removed: Subsequent Events.
+Added: During the year ended December 31, 2024, the Company issued and sold 2,068,246 shares of Common Stock under the ATM for net proceeds of $ 7.9 million, or $ 3.84 per share.
+Added: The Company did not sell any shares of Common Stock under the ATM during the year ended December 31, 2023.
+Added: The Company has issued shares of Common Stock for aggregate gross proceeds of $ 12.2 million under the ATM since the program’s inception.
+Added: On March 27, 2024, the Company filed a shelf registration statement on Form S-3 (the “2024 Registration Statement”).
+Added: Pursuant to the 2024 Registration Statement, the Company may offer and sell securities having an aggregate public offering price of up to $ 200.0 million.
+Added: Restricted Stock Units
+Added: During the year ended December 31, 2024, the Company issued 115,376 shares of Common Stock in settlement of fully vested RSUs.
Common Stock Warrant
33 unchanged sentences
Stock options granted after December 31, 2017 generally vest monthly over a range of 12 to 48 months or vest monthly over a total of 48 months following a one-year cliff and all have a ten-year contractual term.
−Removed: During the year ended December 31, 2023, the Company also issued option awards to members of its Board that vest in full on the first anniversary of the grant date.
+Added: Stock options granted to consultants during the year ended December 31, 2024 vest quarterly over a one-year period, provided the consultants continue to perform services as dictated by their respective consulting agreements with the Company.
+Added: During the years ended December 31, 2024 and 2023, the Company also issued option awards to members of its Board that vest in full on the first anniversary of the grant date.
Stock options granted prior to December 31, 2017 were either fully vested upon grant or generally vested monthly over a range of three to 24 months and have a ten-year term.
11 unchanged sentences
Value (in thousands)
−Removed: Outstanding at January 1, 2023 5,610,893 $ 3.36
+Added: Outstanding as of December 31, 2023 7,523,947 $ 4.01
Granted 3,385,650 $ 3.60
−Removed: Exercised ( 111,206 ) $ 2.92
Forfeited ( 163,218 ) $ 5.76
Expired ( 90,250 ) $ 7.27
−Removed: Outstanding at December 31, 2023 7,523,947 $ 4.01 7.7 $ 9,004
−Removed: Vested and exercisable at December 31, 2023 4,021,147 $ 3.17 7.1 $ 7,055
−Removed: The intrinsic value of stock options exercised during the years ended December 31, 2023 and 2022 was approximately $ 0.5 million and $ 0.6 million, respectively.
−Removed: As of December 31, 2023, total unrecognized compensation costs related to unvested stock option awards granted was approximately $ 12.3 million, which the Company expects to recognize over a weighted-average period of approximately 2.2 years.
+Added: Outstanding as of December 31, 2024 10,656,129 $ 3.83 7.4 $ 2,042
+Added: Vested and exercisable as of December 31, 2024 6,173,546 $ 3.51 6.5 $ 2,015
+Added: No options were exercised during the year ended December 31, 2024.
+Added: The intrinsic value of stock options exercised during the year ended December 31, 2023 was approximately $ 0.5 million.
+Added: As of December 31, 2024, total unrecognized compensation cost related to unvested stock option awards granted was approximately $ 13.8 million, which the Company expects to recognize over a weighted-average period of approximately 2.5 years.
Restricted Stock Units
−Removed: In January 2023, the Company granted a RSU award to each of its then-current employees.
−Removed: These RSU awards vest in equal annual installments on the first three anniversaries of the grant date.
+Added: RSU awards granted to employees during the years ended December 31, 2024 and 2023 vest in equal annual installments on the first three anniversaries of the grant date.
Number of Shares Weighted Average Grant Date Fair Value
−Removed: Unvested as of January 1, 2023 — $ —
+Added: Unvested as of December 31, 2023 328,500 $ 6.11
Granted 1,204,640 $ 4.15
−Removed: Unvested at December 31, 2023 328,500 $ 6.11
−Removed: As of December 31, 2023, total unrecognized compensation costs related to unvested RSUs was approximately $ 1.4 million, which the Company expects to recognize over a weighted-average period of approximately 2.1 years.
+Added: Vested ( 129,198 ) $ 5.86
+Added: Forfeited ( 49,399 ) $ 4.38
+Added: Unvested as of December 31, 2024 1,354,543 $ 4.46
+Added: As of December 31, 2024, total unrecognized compensation cost related to unvested RSUs was approximately $ 3.9 million, which the Company expects to recognize over a weighted-average period of approximately 1.9 years.
Employee Stock Purchase Plan
1 unchanged sentence
The number of shares of Common Stock reserved for issuance automatically increases on January 1 of each calendar year through January 1, 2031, by the lesser of (1) 1 % of the total number of shares of Common Stock outstanding on the last day of the fiscal year before the date of the automatic increase, and (2) 800,000 shares;
−Removed: provided that before the date of any such increase, the Board may determine that such increase will be less than the amount set forth in clauses (1) and (2).
+Added: provided, however, that before the date of any such increase, the Board may determine that such increase will be less than the amount set forth in clauses (1) and (2).
On January 1, 2024, the number of shares of Common Stock reserved for issuance under the ESPP automatically increased by 579,105 shares.
−Removed: As of December 31, 2023, there are a total of 1,189,983 shares authorized for issuance and there have been no purchases of shares under the ESPP.
+Added: As of December 31, 2024, there were a total of 1,769,088 shares authorized for issuance and there have been no purchases of shares under the ESPP.
The Company has not recorded any tax provision or benefit for federal income taxes for the years ended December 31, 2024 and 2023.
26 unchanged sentences
Other ( 65 ) ( 163 )
−Removed: Depreciation — ( 30 )
Total deferred tax liabilities ( 273 ) ( 437 )
16 unchanged sentences
The Company has not completed a formal analysis of the potential impact of Section 382 on its deferred tax assets as of December 31, 2024.
−Removed: Until this analysis has been completed, the Company has
−Removed: not adjusted any of its deferred tax assets, including NOLs or R&D credits.
+Added: Until this analysis has been completed, the Company has not adjusted any of its deferred tax assets, including NOLs or R&D credits.
The Company will reassess the amount of NOLs and credits subject to limitation under Section 382 when a study is complete.
5 unchanged sentences
However, the Company’s tax years from 2004 and after are subject to examination by the United States and state taxing authorities due to the carry forward of unused NOLs and R&D credits.
+Added: SEGMENT REPORTING
+Added: The Company manages its operations as a single segment.
+Added: The CODM assesses performance and allocates resources for its clinical-stage biopharmaceutical segment based on net loss, which is reported on the statement of operations and comprehensive loss as net loss.
+Added: The CODM is regularly provided with actual, budgeted and forecasted expense information to make decisions on resource allocation and assess performance of the business and monitor budget versus actual results using loss from operations.
+Added: Substantially all long-lived assets are located in the U.S.
+Added: The measure of segment assets is reported on the balance sheet as total assets.
+Added: The following table presents selected financial information about the Company’s single operating segment for the years ended December 31, 2024 and 2023 (in thousands):
+Added: Year Ended December 31,
+Added: Operating expenses
+Added: Research and development
+Added: External costs (1) $ 71,188 $ 25,405
+Added: Internally-managed costs (2) 19,062 15,025
+Added: General and administrative (3) 14,069 14,506
+Added: Other segment expenses (4) 9,698 6,202
+Added: Other income, net ( 11,688 ) ( 8,767 )
+Added: Segment net loss $ 102,329 $ 52,371
+Added: (1) Includes a $ 0.7 million non-cash charge for the year ended December 31, 2023.
+Added: (2) Includes Acumen-managed research, consultants and contractors, as well as internal personnel and operating expenses, and excludes stock-based compensation expense and depreciation.
+Added: (3) Excludes stock-based compensation expense and depreciation.
+Added: (4) Other segment expenses include stock-based compensation expense and depreciation.
COMMITMENTS AND CONTINGENCIES
4 unchanged sentences
Under the terms of the Halozyme License Agreement, Halozyme granted the Company a non-exclusive license to Halozyme’s drug delivery technology for the development of a subcutaneous formulation of sabirnetug (such combination, the “Halozyme Product”).
−Removed: For the year ended December 31, 2023, the Company recorded R&D expense with an offsetting accrual in accrued expenses and other current liabilities as of December 31, 2023, for the majority of the seven-figure upfront license payment for the Halozyme Product (the “Upfront Payment”), as the Halozyme Product is in its development stage and does not have an alternative future use.
−Removed: Subsequent Events for more information regarding the Upfront Payment.
−Removed: Additionally, the Company will make milestone payments tied to achievement of certain development and commercialization milestone events with respect to the Halozyme Product, as well as milestone payments based on achievement of certain net sales levels of the Halozyme Product.
+Added: In January 2024, the Company paid a seven-figure upfront license payment for the Halozyme Product, which was included in accrued expenses and other current liabilities as of December 31, 2023.
+Added: The Company is required to make milestone payments upon the achievement of certain development and commercialization events with respect to the Halozyme Product, as well as milestone payments based on achievement of certain net sales levels of the Halozyme Product.
The Company will also make single-digit royalty payments based on worldwide net sales of the Halozyme Product.
+Added: The upfront license payment and milestones are recorded as in-process research and development expense when incurred.
In November 2022, the Company entered into a License Agreement (“Lonza License Agreement”) with Lonza Sales AG (“Lonza”).
2 unchanged sentences
The Company is also required to pay certain royalties upon commercialization and annual payments on a country-by-country basis in respect of the manufacturing and sale of the Lonza Product, which include (i) a royalty of less than 1 % on net sales where Lonza manufactures the Lonza Product, (ii) an annual royalty payment in Swiss Francs in the low six-digits and a royalty of less than 1 % on net sales where the Company manufactures the Lonza Product and (iii) an annual payment in Swiss Francs in the mid six-digits per sublicense and a royalty on net sales in the low single digits where a third party manufactures the Lonza Product.
−Removed: These payment obligations would expire ten years from the first commercial sales of the Lonza Product in such country of sale.
+Added: These payment obligations expire ten years from the first commercial sales of the Lonza Product in such country of sale.
SUBSEQUENT EVENTS
−Removed: In January 2024, the Company issued 2,068,246 shares of Common Stock under the ATM for net proceeds of $ 7.9 million, or $ 3.84 per share.
−Removed: In January 2024, the Company paid the seven-figure Upfront Payment for the Halozyme Agreement.
−Removed: Commitments and Contingencies for additional information.
+Added: In January 2025, the Company issued 446,756 shares of its Common Stock in settlement of fully vested RSUs.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
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.