Financial Performance and Expenses - Net loss for the nine months ended September 30, 2024 was 65.2million,with9159.2 million) attributed to research and development spending[102] - Research and development expenses increased by 144% to 27.2millioninQ32024comparedtoQ32023[112]−Generalandadministrativeexpensesincreasedby35.0 million in Q3 2024 compared to Q3 2023[112] - Research and development expenses increased by 16.0millionto27.2 million for the three months ended September 30, 2024, primarily due to a 13.4millionincreaseincostsassociatedwiththePhase2ALTITUDE−ADclinicaltrial[113]−Generalandadministrativeexpensesincreasedby0.1 million to 5.0millionforthethreemonthsendedSeptember30,2024,primarilyduetohigherpersonnelcosts[114]−Otherincomedecreasedby0.6 million to 2.5millionforthethreemonthsendedSeptember30,2024,duetoanincreaseininterestexpenserelatedtoborrowings[115]−Researchanddevelopmentexpensesincreasedby30.2 million to 59.2millionfortheninemonthsendedSeptember30,2024,primarilyduetoa20.9 million increase in costs associated with the Phase 2 ALTITUDE-AD clinical trial[118] - General and administrative expenses increased by 1.6millionto15.2 million for the nine months ended September 30, 2024, primarily due to higher personnel costs[119] - Other income increased by 2.4millionto9.2 million for the nine months ended September 30, 2024, primarily due to a 4.5millionincreaseininterestincome[120]−Netcashusedinoperatingactivitiesincreasedby24.2 million to 59.0millionfortheninemonthsendedSeptember30,2024,primarilyduetoanincreaseinnetloss[129]CashandFunding−Cashandcashequivalentsandmarketablesecuritiestotaled258.9 million as of September 30, 2024, including 30.0millionfromthefirsttrancheoftheK2HVloan[104]−Thecompanyexpectsitsexistingcashandcashequivalentstofundoperationsintothefirsthalfof2027[104]−Thecompanyenteredintoa50 million loan agreement with K2HV in November 2023, with 30millionalreadydrawn[100]−InQ32024,thecompanyissued2,068,246sharesofcommonstockunderitsATMprogramfornetproceedsof7.9 million (3.84pershare)[101]−Cashprovidedbyinvestingactivitiesincreasedby141.2 million to 18.4millionfortheninemonthsendedSeptember30,2024,primarilyduetoproceedsfrommaturitiesofmarketablesecurities[132]−Cashprovidedbyfinancingactivitiesdecreasedby115.7 million to 6.9millionfortheninemonthsendedSeptember30,2024,primarilyduetolowernetproceedsfromtheissuanceofcommonstock[133]−Thecompanyexpectsitsexistingcashandcashequivalentsandmarketablesecuritiestotaling258.9 million to fund operating expenses and capital expenditure requirements into the first half of 2027[127] - Additional funding may result in dilution to stockholders, imposition of debt covenants, and repayment obligations, potentially affecting the company's business[138] - The company's ability to raise capital may be adversely impacted by worsening global economic conditions, disruptions in credit markets, and rising interest rates[138] Clinical Trials and Drug Development - The Phase 2 ALTITUDE-AD clinical trial for sabirnetug is expected to complete enrollment in the first half of 2025 with approximately 540 participants[96] - Sabirnetug demonstrated a 10.4% overall rate of ARIA-E in the INTERCEPT-AD trial, with dose-dependent rates of 7% (10/25 mg/kg) and 21% (60 mg/kg)[95] Financial Position and Deficits - The company has an accumulated deficit of 288.0millionandworkingcapitalof187.7 million as of September 30, 2024[102] Accounting and Reporting - Financial statements preparation requires significant estimates and assumptions, which may differ under different conditions[139] - The company has elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act[142] - The company qualifies as an "emerging growth company" and may take advantage of reduced disclosure requirements until December 31, 2026, or until specific financial thresholds are met[144] - The company is also a "smaller reporting company" with a market value of shares held by non-affiliates less than 700millionandannualrevenuebelow100 million[145] - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[145] - The company may continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[145] - Quantitative and qualitative disclosures about market risk are not applicable to the company as a smaller reporting company[146]