Company Performance - AC Immune reported a quarterly loss of $0.25 per share, which was worse than the Zacks Consensus Estimate of $0.42, and compared to a loss of $0.22 per share a year ago, indicating a significant earnings surprise of -159.52% [1] - The company generated revenues of $0.76 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 99.17%, and this is an increase from zero revenues a year ago [1] - Over the last four quarters, AC Immune has only surpassed consensus EPS estimates once [1] Stock Performance - AC Immune shares have declined approximately 30.2% since the beginning of the year, contrasting with the S&P 500's gain of 8.7% [2] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.22 on $1 million in revenues, and for the current fiscal year, it is -$0.20 on $99.11 million in revenues [4] - The estimate revisions trend for AC Immune is currently unfavorable, resulting in a Zacks Rank 4 (Sell), indicating expected underperformance in the near future [4] Industry Context - The Medical - Biomedical and Genetics industry, to which AC Immune belongs, is currently in the top 37% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [5] - Another company in the same industry, Agenus, is expected to report a quarterly loss of $1.33 per share, reflecting a year-over-year change of +66.8%, with revenues anticipated to be $64.73 million, up 155.8% from the year-ago quarter [5][6]

Core Insights - AC Immune has reported strong financial results for Q2 2024, highlighting a partnership with Takeda for ACI-24.060, which includes an upfront payment of $100 million and potential milestones totaling approximately $2.1 billion [1][3][6] - The company is advancing its clinical trials, with the ABATE Phase 2 trial for ACI-24.060 in Alzheimer's disease on track and the VacSYn Phase 2 trial for ACI-7104.056 in Parkinson's disease expected to provide interim data in H2 2024 [1][5][6] - AC Immune's cash position is robust, with a balance of CHF 175.2 million, providing sufficient runway for three years of operations [1][6] Financial Highlights - The company recorded CHF 0.7 million in contract revenues for Q2 2024, a significant increase from nil in the prior period, primarily due to the agreement with Takeda [6][13] - Research and development expenses rose to CHF 17.1 million in Q2 2024 from CHF 13.7 million in the same period of 2023, driven by increased clinical activities [6][14] - The net loss for the period was CHF 22.8 million, compared to a net loss of CHF 16.8 million in Q2 2023, reflecting higher operating expenses [6][15] Clinical Development Updates - Enrollment in the ACI-24.060 ABATE Phase 2 trial for Alzheimer's disease is progressing as planned [2][3] - The company has completed regulatory toxicology studies for its anti-TDP-43 monoclonal antibody candidate, enabling the IND filing [3] - ACI-19764, a potent NLRP3 inhibitor, has shown promising preclinical results and is expected to file an IND soon [3][4] Strategic Partnerships and Innovations - The partnership with Takeda is expected to enhance AC Immune's capabilities in developing best-in-class immunotherapies targeting Abeta [2][3] - The morADC platform, combining SupraAntigen® and Morphomer® technologies, is showing promise in preclinical models for neurodegenerative diseases [2][3] - The company is also developing a first-in-class TDP-43 PET tracer, [18F]ACI-19626, for monitoring TDP-43 aggregates [4]

Core Viewpoint - AC Immune SA has introduced a novel class of drug candidates called morADC (Morphomer® Antibody Drug Conjugate) aimed at improving efficacy in treating neurodegenerative diseases, as presented at the AAIC 2024 conference [1][2][3] Group 1: Technology Overview - morADC technology combines proprietary brain-penetrant small molecules (Morphomers®) with monoclonal antibodies (SupraAntigen®), targeting toxic proteins in the central nervous system (CNS) [1][2] - The morADC platform allows for single or dual-targeting strategies, enhancing therapeutic efficacy by delivering combination therapy in a single agent [2][5] - Significant synergies were observed with morADC, leading to increased blood-brain barrier penetration and enhanced potency against protein aggregation compared to using antibodies or small molecules alone [1][2][5] Group 2: Clinical Implications - The morADC technology is designed to address critical targets such as Abeta, Tau, and a-synuclein, which are associated with neurodegenerative diseases [2] - Single-targeting morADC demonstrated significant anti-aggregation effects, while dual-targeting morADC showed even greater efficacy [2][5] - The technology aims to overcome challenges faced by existing treatment modalities, potentially improving clinical outcomes for patients suffering from neurodegenerative diseases [5] Group 3: Company Background - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision medicine for neurodegenerative diseases, with a diverse pipeline that includes sixteen therapeutic and diagnostic programs [6] - The company has a strong history of strategic partnerships with leading pharmaceutical companies, resulting in substantial non-dilutive funding and milestone payments [6]

Core Viewpoint - AC Immune SA is advancing its active immunotherapy candidates ACI-24.060 for Alzheimer's Disease (AD) and ACI-7104.056 for early Parkinson's Disease (PD), with significant upcoming catalysts and a partnership with Takeda Pharmaceuticals that enhances its financial position and development prospects [1][4][14]. Group 1: ACI-24.060 Development - ACI-24.060 is currently being tested in the phase 2 ABATE trial, targeting both AD patients and non-demented adults with Down Syndrome (DS) [1][6]. - Two key catalysts are anticipated: updated guidance on interim results from the ABATE trial expected in the second half of 2024, and interim safety and immunogenicity data for DS patients with AD [2][7]. - The partnership with Takeda includes an upfront payment of $100 million and potential milestone payments up to $2.1 billion, which will support further pipeline development [2][9]. Group 2: Market Opportunity - The global Alzheimer's therapeutics market is projected to exceed $8.18 billion by 2032, with a significant portion of the patient population being those with Down Syndrome, where approximately 30% are expected to develop AD [5][15]. - The global Parkinson's Disease drugs market is expected to reach $6.69 billion by 2029, providing another substantial opportunity for AC Immune with its ACI-7104.056 candidate [15][16]. Group 3: Financial Position - As of March 31, 2024, AC Immune reported total cash of $118.7 million, sufficient to fund operations for at least three years, largely due to partnership agreements [10]. - The company incurred R&D expenses of $17.4 million and G&A expenses of $5.6 million for the three months ending March 31, 2024, resulting in a total cash burn of $23 million per quarter [10].

Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company specializing in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins [3] - The company has two clinically validated technology platforms, SupraAntigen® and Morphomer®, which support a diversified pipeline of 16 therapeutic and diagnostic programs, with five in Phase 2 clinical trials and one in Phase 3 [3] - AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding through milestone payments and royalties [3] AAIC 2024 Presentations - AC Immune will present three oral presentations at the Alzheimer's Association International Conference (AAIC 2024) in Philadelphia, PA, from July 28 to August 1, 2024 [1] - The presentations will cover the discovery and preclinical development of [18F]ACI-19626, a first-in-class TDP-43-PET tracer, on July 29, 2024 [2] - Another presentation will discuss ACI-24.060, an active immunotherapy that induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, on July 30, 2024 [2] - The third presentation will introduce morADC (Morphomer®-Antibody Drug Conjugates), a new class of neurodegenerative disease-fighting drugs, on July 31, 2024 [2] Technology Platforms - SupraAntigen® is a registered trademark of AC Immune SA in multiple territories, including AU, EU, CH, GB, JP, RU, SG, and USA [4] - Morphomer® is also a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO, and RU [4]

Core Insights - AC Immune SA is participating in the Jefferies 2024 Global Healthcare Conference on June 5-6, 2024, in New York, with a fireside chat scheduled for June 5 at 3:30 PM (ET) [1] - The company is focused on precision medicine for neurodegenerative diseases, including Alzheimer's and Parkinson's, and has a diversified pipeline with 16 therapeutic and diagnostic programs [3] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company recognized as a leader in precision prevention for neurodegenerative diseases driven by misfolded proteins [3] - The company has two clinically validated technology platforms, SupraAntigen® and Morphomer®, which support its pipeline [3] - AC Immune has secured strategic partnerships with leading pharmaceutical companies, resulting in over $4.5 billion in potential milestone payments and royalties [3]

Core Insights - AC Immune's stock is experiencing an increase following the release of its Q1 2024 earnings report, which includes a significant operational update [1] - The company has entered into a collaboration agreement with Takeda Pharmaceutical, involving a licensing agreement for AC Immune's ACI-24.060, which includes an upfront payment of $100 million and potential payments of up to $2.1 billion [1] Financial Highlights - The collaboration with Takeda Pharmaceutical includes an upfront payment of $100 million to AC Immune [1] - Potential future payments from the agreement could reach up to $2.1 billion, contingent on option exercise and milestones [1] Market Performance - AC Immune's stock has risen by 45% as of Monday morning, with over 6.6 million shares traded, significantly exceeding the average daily trading volume of approximately 185,000 shares [2] - The company is expected to report initial results from its ongoing Phase 2 clinical trial of ACI-24.060 this month, with further data anticipated in the second half of 2024 [2]

Financial Performance - The company reported a net loss of CHF 17,862 thousand for the three months ended March 31, 2024, compared to a net loss of CHF 17,513 thousand for the same period in 2023, indicating a slight increase in losses[7]. - Total comprehensive loss for the period was CHF 17,846 thousand, slightly better than the CHF 17,521 thousand reported in the previous year[7]. - For the three months ended March 31, 2024, the net loss attributable to equity holders was CHF 17,862 thousand, compared to a loss of CHF 17,513 thousand for the same period in 2023[32]. - The diluted loss per share for the period was CHF (0.18), compared to CHF (0.21) for the same period last year, showing an improvement in loss per share[5]. - The basic and diluted loss per share for the period was CHF (0.18), an improvement from CHF (0.21) in the prior year[32]. Assets and Liabilities - Total assets decreased from CHF 182,814 thousand as of December 31, 2023, to CHF 167,281 thousand as of March 31, 2024, representing a decline of approximately 8.5%[2]. - Shareholders' equity decreased from CHF 160,643 thousand to CHF 144,681 thousand, a reduction of about 9.9%[2]. - Cash and cash equivalents decreased from CHF 78,494 thousand to CHF 57,009 thousand, a decline of approximately 27.4%[2]. - Total current liabilities increased from CHF 13,576 thousand to CHF 14,124 thousand, an increase of about 4%[2]. - As of March 31, 2024, cash and cash equivalents totaled CHF 57,009 thousand, down from CHF 57,434 thousand at the end of March 2023[1]. - AC Immune's accrued expenses totaled CHF 10.5 million as of March 31, 2024, down from CHF 11.1 million as of December 31, 2023, reflecting a decrease of 4.9%[43]. Cash Flow and Investments - Cash provided by operating activities was CHF 704 thousand, a significant recovery from a cash used of CHF (16,769) thousand in the same period last year[1]. - The company reported net cash flows used in investing activities of CHF (23,561) thousand, compared to cash provided of CHF 42,800 thousand in the prior year[1]. - The company invested CHF 0.2 million in laboratory equipment during the first quarter of 2024, representing a 1.6% increase from the beginning of the year[36]. - The total cash outflow for leases was CHF 391,000 for the three months ended March 31, 2024, compared to CHF 458,000 in the prior year[40]. Financial Position - The company has a cash position of CHF 57.0 million and short-term financial assets of CHF 47.8 million as of March 31, 2024, indicating a stable financial outlook[27]. - Short-term financial assets increased significantly to CHF 47.8 million as of March 31, 2024, compared to CHF 24.6 million as of December 31, 2023, marking an increase of 94.5%[49]. - The company recorded a net financial gain of CHF 2.2 million for the three months ended March 31, 2024, compared to CHF 0.1 million in the same period of 2023, indicating a substantial improvement[52]. Revenue and Grants - The company recognized less than CHF 0.1 million in grant income for the three months ended March 31, 2024, down from CHF 0.4 million in the same period of 2023[31]. - The company has not generated any contract revenues for the three months ended March 31, 2024 and 2023[29]. Collaborations and Agreements - The company announced it will regain all global rights to the anti-amyloid beta antibody crenezumab and the anti-Tau antibody semorinemab following the termination of collaboration agreements with Genentech and Roche[30]. - The company received a CHF 14.8 million milestone payment from Janssen, resulting in a nil balance for accounts receivable as of March 31, 2024[50]. - On May 11, 2024, AC Immune entered into a licensing agreement with Takeda Pharmaceuticals, which includes an upfront payment of USD 100 million (CHF 91 million) and potential total payments of approximately USD 2.1 billion (CHF 1.9 billion)[54].

Core Insights - AC Immune SA reported a landmark collaboration with Takeda for the development of ACI-24.060, which includes an upfront payment of $100 million and potential total payments of approximately $2.1 billion [1][3] - The company is on track to report Phase 2 trial results for ACI-24.060 in Q2 2024, focusing on amyloid plaque reduction in Alzheimer's disease [2][4] - AC Immune has a strong financial position with CHF 104.8 million in cash at the end of Q1 2024, providing a runway for at least three years [6] Financial Highlights - The cash balance as of March 31, 2024, was CHF 104.8 million, an increase from CHF 103.1 million at the end of 2023, including CHF 47.8 million in cash and cash equivalents and CHF 57.0 million in short-term financial assets [6] - Research and development expenses for Q1 2024 were CHF 15.2 million, compared to CHF 13.9 million in the same period in 2023, primarily due to increased clinical expenses for ACI-24.060 [6] - The company reported a net loss of CHF 17.9 million for Q1 2024, slightly higher than the net loss of CHF 17.5 million in Q1 2023 [6][14] Pipeline Developments - ACI-24.060 is currently in the ABATE Phase 2 trial, with full enrollment in cohorts 1 and 2, and cohort 3 expected to complete enrollment by year-end [3] - The ACI-7104.056 VacSYn Phase 2 trial for Parkinson's disease is on track for interim safety and immunogenicity data in H2 2024 [5] - The ACI-35.030 anti-phospho-Tau active immunotherapy is being evaluated in a Phase 2b trial, with the first patient expected to be treated soon [5] Strategic Partnerships - The collaboration with Takeda aims to leverage both companies' expertise in neuroscience, enhancing AC Immune's position in the field of neurodegenerative diseases [2] - The agreement includes tiered royalties on worldwide net sales upon commercialization, further strengthening AC Immune's revenue potential [3]

AC Immune and Takeda Sign Exclusive Option and License Agreement for Active Immunotherapy Targeting Amyloid Beta for Alzheimer's Disease Takeda to receive exclusive option to license global rights to ACI-24.060, a potential first-in-class active immunotherapy designed to delay or slow Alzheimer's disease progressionAC Immune to receive upfront payment of $100 million upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately $2.1 billionAC Immune to h ...