Accessible version US Biopharmaceuticals 2026 Year Ahead: What to expect from our coverage universe in 2026 Price Objective Change Biopharma favorable despite lingering uncertainties Despite its challenges, Biopharma ended 2025 on a high note (NBI +32%, DRG +21% vs. SPX +17%)—with, in our view, reasons for optimism heading into 2026. Admittedly, the macro concerns weighing on 1H25 sentiment (inflation, tariffs) remain overhangs. That said, 1) sector-specific worries, mostly around drug pricing, eased; 2) lo ...

Several biotechnology and pharmaceutical names posted notable gains in after-hours trading on Monday, driven by clinical trial updates, regulatory progress, and investor anticipation ahead of key data releases.Alumis Inc. (ALMS) surged 17.33% to $9.75, adding $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis will be reported on January 6, 2026. The company also confirmed it will host a conference ...

Group 1: Market Movements - Several healthcare and biotech companies experienced notable gains in after-hours trading, driven by clinical updates, recent announcements, and technical rebounds [1] - Kymera Therapeutics Inc. (KYMR) saw a 9.58% increase to $73.00 after hours, following a modest 0.59% rise during the regular session [2] - Ocular Therapeutix Inc. (OCUL) advanced 11.29% to $14.00 after hours, with a 1.21% increase during the day [3] - Guardian Pharmacy Services Inc. (GRDN) shares rose 2.62% to $30.54 in after-hours trading, extending its earlier 1.50% gain [4] - Predictive Oncology Inc. (POAI) jumped 13.62% to $4.84 after hours, recovering from a 22% decline during the regular session [5] - Acumen Pharmaceuticals Inc. (ABOS) edged up 3.23% to $1.92 after hours, following a 6.06% drop during the day [6] - EUDA Health Holdings Ltd. (EUDA) rose 7.72% to $2.93 after hours, recovering from a 6.85% decline earlier [7] - Butterfly Network Inc. (BFLY) gained 4.90% to $3.21 after hours, after finishing the regular session flat [8] Group 2: Company-Specific Updates - Kymera Therapeutics is set to announce results from the BroADen Phase 1b clinical trial of KT-621 for atopic dermatitis on December 8, which has fueled after-hours momentum [2] - Ocular Therapeutix recently announced progress in its HELIOS-3 Phase 3 program for AXPAXLI in diabetic retinopathy, with the first patient randomized on November 24 [3] - Predictive Oncology regained compliance with Nasdaq's minimum stockholders' equity requirement, which has renewed investor confidence [5] - Acumen Pharmaceuticals presented new research at the CTAD conference, highlighting advancements in Alzheimer's treatment [6] - EUDA Health announced a securities purchase agreement for a convertible warrant valued at $100,000, providing financing flexibility for growth initiatives [7]

Core Insights - Acumen Pharmaceuticals is advancing research on a novel therapeutic targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease, presenting findings at the 18th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference [1][2] - The company has demonstrated improved delivery of AβO-targeting monoclonal antibodies to the central nervous system using the transferrin receptor (TfR) pathway, which may enhance brain distribution and efficacy [1][3] - Recruitment strategies from the Phase 2 ALTITUDE-AD clinical trial indicate that site databases and physician referrals are the most effective methods for participant recruitment [1][4] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for Alzheimer's disease, specifically targeting toxic soluble AβOs [9] - The investigational product candidate, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets soluble AβOs and has received Fast Track designation from the FDA for early Alzheimer's disease treatment [6][9] - The ALTITUDE-AD trial, initiated in 2024, is a Phase 2 study evaluating the efficacy and safety of sabirnetug in slowing cognitive decline in early Alzheimer's disease patients [8] Research and Development - The collaboration with JCR Pharmaceuticals has led to the development of TfR-targeting antibodies for clinical testing, enhancing the delivery of AβO-targeting therapies [1][2] - Fusion of TfR-binding antibody fragments with ACU193 has resulted in significant increases in brain penetration, achieving 15 to 68 times higher levels in mouse models [3] - The ALTITUDE-AD trial has screened 2,362 participants across 76 sites, with 542 enrolled, providing insights for improving future trial recruitment efficiency [4][8]

Core Insights - Acumen Pharmaceuticals is set to present new findings at the 18th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference, focusing on its Phase 2 ALTITUDE-AD study of sabirnetug and a nonclinical Enhanced Brain Delivery (EBD™) study [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing sabirnetug, a humanized monoclonal antibody targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment [7] - The company aims to address the neurodegenerative process in Alzheimer's by selectively targeting toxic soluble AβOs, which are linked to synaptic dysfunction and neurodegeneration [5][7] Research and Development - Sabirnetug is the first humanized monoclonal antibody to show selective target engagement of AβOs in early symptomatic Alzheimer's patients [2] - The Phase 2 ALTITUDE-AD study, initiated in 2024, has enrolled 542 individuals and is designed to evaluate the efficacy and safety of sabirnetug in slowing cognitive decline compared to placebo [6] - Acumen's collaboration with JCR Pharmaceuticals focuses on enhancing drug delivery to the brain using JCR's blood-brain barrier-penetrating technology [3][8] Upcoming Presentations - Acumen will present recruitment strategies for the ALTITUDE-AD trial and findings on the EBD study at the CTAD conference from December 1-4, 2025 [1][4]

Core Insights - Acumen Pharmaceuticals has initiated the open-label extension of its Phase 2 ALTITUDE-AD clinical trial for sabirnetug (ACU193), targeting early Alzheimer's disease [1][2][3] - The open-label extension allows participants from the placebo-controlled phase to receive sabirnetug for an additional 52 weeks, maintaining the same clinical measures and safety monitoring [2][3] - Sabirnetug is the first humanized monoclonal antibody to selectively target soluble amyloid beta oligomers (AβOs), which are implicated in the neurodegenerative process of Alzheimer's disease [3][5] - The company anticipates reporting topline results from the ALTITUDE-AD trial in late 2026 [4] Company Overview - Acumen Pharmaceuticals is focused on developing therapies targeting toxic soluble AβOs for Alzheimer's disease, with sabirnetug currently in Phase 2 trials following positive Phase 1 results [7][8] - The ALTITUDE-AD trial has enrolled 542 participants with early Alzheimer's disease across multiple sites in the U.S., Canada, EU, and the UK [6] - Sabirnetug has received Fast Track designation from the U.S. FDA for the treatment of early Alzheimer's disease [5]

Financial Performance - The company reported a net loss of $96.2 million for the nine months ended September 30, 2025, compared to a net loss of $65.2 million for the same period in 2024, with approximately 88% of the loss attributed to research and development spending [120]. - Net loss increased by $31.0 million, or 48%, to $96.2 million for the nine months ended September 30, 2025 [133]. - Other income decreased by $6.8 million to $2.4 million for the nine months ended September 30, 2025, primarily due to a $5.2 million decrease in interest income [136]. - Interest income decreased by 53% to $1.64 million for the three months ended September 30, 2025, compared to $3.50 million in 2024 [129]. - Cash provided by financing activities decreased by $7.0 million to $(36) thousand for the nine months ended September 30, 2025 [148]. Research and Development - Research and development expenses decreased by 19% to $21.97 million for the three months ended September 30, 2025, down from $27.25 million in 2024, primarily due to reduced costs associated with the ALTITUDE-AD clinical trial [129][130]. - The company expects to continue increasing research and development expenses as it advances sabirnetug in clinical development and expands its product candidate portfolio [120]. - Research and development expenses increased by $25.1 million, or 42%, to $84.4 million for the nine months ended September 30, 2025, driven mainly by costs associated with the ALTITUDE-AD clinical trial [134]. - The company completed enrollment in the Phase 2 ALTITUDE-AD clinical trial in March 2025, with a total of 542 participants expected to be evaluated for the efficacy of the drug candidate sabirnetug [114]. Cash and Funding - The company has cash and cash equivalents of $136.1 million as of September 30, 2025, which is expected to fund operations into early 2027 [122]. - Cash and cash equivalents and marketable securities totaled $136.1 million as of September 30, 2025, expected to fund operations into early 2027 [142]. - The company has borrowed $30 million under a loan agreement with K2 HealthVentures, with an additional $20 million available upon request [118]. - The company anticipates needing substantial additional funding for future operations and may seek third-party collaborators for commercialization [149]. Operating Expenses - The company incurred total operating expenses of $26.51 million for the three months ended September 30, 2025, an 18% decrease from $32.27 million in the same period of 2024 [129]. - Total operating expenses rose by $24.2 million, or 33%, to $98.6 million for the nine months ended September 30, 2025 [133]. - Net cash used in operating activities increased by $37.4 million to $96.4 million for the nine months ended September 30, 2025 [145]. Company Status and Compliance - The company has not generated any revenue from product sales and relies on funding through equity offerings and debt financings [117]. - The company has not generated revenue from product sales and does not expect to do so for several years [137]. - The company may cease to qualify as an emerging growth company by December 31, 2026, or if total annual gross revenues exceed $1.235 billion [158]. - The market value of the company's shares held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [159]. - The company’s annual revenue was less than $100 million during the most recently completed fiscal year [159]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company [159]. - The company has taken advantage of reduced reporting requirements in its Quarterly Report on Form 10-Q [158]. Intellectual Property and Competition - The company needs to maintain, expand, and defend its intellectual property portfolio, which may involve payments related to licensing and enforcement [157]. - The company faces competition from other drugs and product candidates in the market [157]. - The company may enter into collaborations, licensing, or other arrangements for product commercialization [157]. - The company may need to retain management and hire scientific and clinical personnel to support its operations [157]. Collaborations - A collaboration agreement with JCR Pharmaceuticals was established in July 2025, which includes potential milestone payments of up to $555 million and royalties on sales of products developed from the partnership [116].

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had $136.1 million in cash and marketable securities, expected to support clinical and operational activities into early 2027 [10] - R&D expenses for Q3 2025 were $22 million, a decrease from the prior year primarily due to reduced CRO costs associated with the ALTITUDE-AD clinical trial [10] - G&A expenses were $4.5 million in Q3 2025, down due to reductions in legal fees, audit, and recruiting expenses [10] - The company reported a loss from operations and a net loss of $26.5 million for the quarter [11] Business Line Data and Key Metrics Changes - The ALTITUDE-AD trial is progressing with 542 participants enrolled, and some are beginning to complete the placebo-controlled phase [4][5] - The open-label extension of the trial allows participants to receive sabirnetug at 35 mg per kg every four weeks for up to 52 weeks, aimed at gathering long-term safety and efficacy data [5] Market Data and Key Metrics Changes - The company is exploring a strategic collaboration with JCR Pharmaceuticals to develop an Alzheimer's disease product that combines A-beta oligomer selective antibody expertise with blood-brain barrier technology [6][8] Company Strategy and Development Direction - The company is focused on advancing the ALTITUDE-AD trial and the Enhanced Brain Delivery (EBD) program, targeting synaptotoxic A-beta oligomers for Alzheimer's treatment [4][11] - The addition of Dr. George Golembeski to the board is expected to enhance strategic initiatives and business development efforts [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the ALTITUDE-AD trial and anticipates sharing top-line results in late 2026 [11] - The EBD program is seen as a potential next-generation product opportunity in Alzheimer's treatment [5][11] Other Important Information - The company plans to present data at upcoming medical conferences related to the EBD program [7] - A non-clinical data package, including a non-human primate study, is expected in early 2026 to inform decisions on advancing development candidates [8] Q&A Session Summary Question: What are the criteria for the early transferrin data for a go/no-go decision? - Management indicated that they are looking for a meaningful increase in overall exposure of sabirnetug in the brain, which could enhance efficacy and safety [15][16] Question: How does the Evoke trials impact the company's approach? - Management is monitoring the GLP-1 studies closely and believes that improved metabolic profiles could positively affect Alzheimer's patients [18] Question: Will both candidates in the shuttle program be advanced simultaneously? - It is too early to determine if one or both candidates will advance, as it will be data-dependent in early 2026 [36] Question: What biomarkers will be included in the non-clinical data package? - The data package will include preclinical studies on pharmacokinetics and biomarker profiles, including A-beta levels and synaptic markers [32][33] Question: What is the minimum expectation from the ALTITUDE-AD study? - The primary outcome will be assessed using the iADRS scale, and management is looking for a clear and demonstrable effect on clinical scales [40][42]

Financial Performance - Acumen reported cash, cash equivalents, and marketable securities of $136.1 million as of September 30, 2025, down from $166.2 million as of June 30, 2025, expected to support operations into early 2027[5] - Loss from operations for Q3 2025 was $26.5 million, compared to $32.3 million in Q3 2024, reflecting decreased R&D expenses[9] - Net loss for Q3 2025 was $26.5 million, compared to $29.8 million in Q3 2024[9] - Net loss for the nine months ended September 30, 2025, was $96,197,000, compared to a net loss of $65,175,000 for the same period in 2024, representing a 47.7% increase in losses[22] - Net cash used in operating activities for the nine months ended September 30, 2025, was $96,442,000, up from $59,000,000 in 2024, indicating a significant increase in cash outflow[22] Research and Development - Research and Development (R&D) expenses for Q3 2025 were $22.0 million, a decrease from $27.2 million in Q3 2024, primarily due to reduced CRO costs associated with the ALTITUDE-AD clinical trial[9] - The company expects to report topline results for the ALTITUDE-AD Phase 2 study in late 2026, investigating sabirnetug for early Alzheimer's disease[5] - The first patient in the open-label extension of the ALTITUDE-AD trial is expected to be dosed in November 2025[6] - Acumen anticipates non-clinical data to support the development of an Enhanced Brain Delivery therapy in early 2026[9] Administrative Expenses - General and Administrative (G&A) expenses were $4.5 million for Q3 2025, down from $5.0 million in Q3 2024, attributed to reductions in legal and recruiting expenses[9] Cash Flow and Investments - Cash and cash equivalents and restricted cash at the end of the period increased to $47,064,000 from $33,420,000 at the end of the previous period[22] - Net cash provided by investing activities was $107,683,000 for the nine months ended September 30, 2025, compared to $18,364,000 in 2024, showing a substantial increase in cash inflow from investments[22] - Purchases of marketable securities totaled $38,056,000 in 2025, down from $155,631,000 in 2024, reflecting a decrease of approximately 75.6%[22] - Proceeds from maturities and sales of marketable securities were $145,827,000 in 2025, compared to $174,011,000 in 2024, indicating a decrease of about 16.2%[22] - The company reported a realized gain on marketable securities of $(17,000) in 2025, compared to $(97,000) in 2024, indicating a smaller loss[22] Clinical Trial Expenses - Accrued clinical trial expenses decreased significantly from $8,130,000 in 2024 to $5,460,000 in 2025, a reduction of approximately 32.6%[22] Board of Directors - The addition of George Golumbeski, Ph.D., to the Board of Directors increases the board size to eight members, bringing over 30 years of biopharma experience[9] Partnerships - The company has an exclusive right to develop up to two candidates as part of its partnership with JCR Pharmaceuticals, expected to be exercised in early 2026[9] Stock-Based Compensation - Stock-based compensation expense increased slightly to $7,433,000 in 2025 from $7,292,000 in 2024[22] Financing Activities - The company had a net cash used in financing activities of $(36,000) in 2025, compared to a net cash provided of $6,937,000 in 2024, showing a shift in financing cash flow[22]

Core Insights - Acumen Pharmaceuticals reported strong operational progress in Q3 2025, focusing on its Phase 2 trial of sabirnetug and the Enhanced Brain Delivery program [2][5] - The company aims to translate advanced science into innovative medicines for Alzheimer's disease while maximizing shareholder value [2] - Anticipated non-clinical data in early 2026 and topline results from the ALTITUDE-AD Phase 2 study in late 2026 are expected to provide insights into the role of amyloid beta oligomers in Alzheimer's disease [2][5] Recent Highlights - The first patient is expected to be dosed in the open-label extension of the ALTITUDE-AD trial in November 2025 [6] - George Golumbeski, Ph.D., was appointed as Chairman of the Board, bringing over 30 years of biotechnology experience [6] - Acumen has exclusive rights to develop up to two candidates in partnership with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [6] Financial Results - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $136.1 million, down from $166.2 million as of June 30, 2025, expected to support operations into early 2027 [5][14] - Research and Development (R&D) expenses decreased to $22.0 million in Q3 2025 from $27.2 million in Q3 2024, primarily due to reduced costs associated with the ALTITUDE-AD trial [6][14] - General and Administrative (G&A) expenses were $4.5 million for Q3 2025, down from $5.0 million in Q3 2024, attributed to lower legal and recruiting expenses [6][7] Loss and Equity - Loss from operations was $26.5 million for Q3 2025, compared to $32.3 million for Q3 2024, reflecting decreased R&D expenses [14] - Net loss for Q3 2025 was $26.5 million, down from $29.8 million in Q3 2024 [14] - Total stockholders' equity as of September 30, 2025, was $93.2 million, a decrease from $181.8 million as of December 31, 2024 [18]