Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023, indicating a significant increase in losses [41] - Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, compared with approximately $20.3 million for 2023, reflecting a substantial increase in investment in R&D [41] - General and administrative expenses were approximately $9.5 million for the year ended December 31, 2024, compared with approximately $9.6 million for 2023, showing a slight decrease [41] - As of December 31, 2024, the company had cash and cash equivalents of approximately $20.9 million, with an additional $5.4 million raised since year-end through the use of the ATM [42] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease enrolled 208 patients across eight countries, with nearly 800 patients screened, indicating a rigorous patient selection process [15][16] - The CARE-PC trial using IncMUNE for treating metastatic prostate cancer has made steady progress, with completion of dosing in the Phase 1 dose escalation part and ongoing dosing in the Phase 2 part [18] Market Data and Key Metrics Changes - The company has pivoted to solid tumors with the INCMUNE platform, believing that future opportunities are greater in this area compared to hematologic diseases [17] Company Strategy and Development Direction - The company aims to challenge the traditional amyloid-centric paradigm of Alzheimer's disease treatment by focusing on neuroinflammation as a primary driver [14][35] - The addition of Cordstrom has introduced a third therapeutic platform, which is expected to accelerate the timeline to becoming a commercial entity [37] - The company plans to file a Biologics License Application (BLA) for Cordstrom in the first quarter of next year, marking a significant milestone towards revenue generation [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [35][36] - The company is focused on achieving primary clinical objectives while remaining cost-prudent, with expectations of sufficient cash to fund operations through Q3 2025 [42][43] Other Important Information - The company has received orphan drug status and rare pediatric disease designation for Cordstrom, differentiating it from other therapies by providing a systemic disease-modifying approach [22] Q&A Session Summary Question: Is the 12-month open-label trial required for filing? - Management indicated that they have access to all clinical data from the current trial and believe it will be adequate for a BLA submission [51] Question: Will the EMAC and CDR results be staggered? - Both EMAC and CDR results will be released simultaneously when the data becomes public [56][57] Question: Are there any dropouts in the Phase II trial? - Dropouts are less than expected, primarily due to typical elderly-related issues rather than drug efficacy or safety concerns [76] Question: How does the company plan to commercialize Cordstrom? - The company aims to move forward independently but may seek a partner for distribution and marketing as they approach commercialization [82][83] Question: Will the BLA for Cordstrom be filed in the UK and US? - The company expects to have all necessary data ready for filing in the first quarter of 2025, with ongoing preparations for both markets [90][91]

Core Insights - AbbVie is set to present new data from its early oncology research at the upcoming AACR Annual Meeting, focusing on investigational molecules ABBV-969 and ABBV-514 for hard-to-treat tumors [1][4][12] - The company aims to advance innovative therapies for patients with difficult-to-treat cancers, emphasizing the importance of early-stage research in addressing unmet medical needs [1][9] AbbVie’s Investigational Therapies - ABBV-969 is a dual-targeted antibody-drug conjugate (ADC) designed to target tumor cells expressing STEAP1 and/or PSMA antigens, currently in Phase 1 clinical trials for metastatic castration-resistant prostate cancer (mCRPC) [1][7][12] - ABBV-514 is a novel CCR8-targeting antibody that shows promise in enhancing anti-tumor immunity and is being evaluated in Phase 1 trials for non-small cell lung cancer (NSCLC) and head and neck cancer [1][7][12] Research Focus Areas - Presentations will include analyses of treatment resistance and biomarker discovery based on real-world data, which are critical for developing precision medicine [1][5][12] - A study will explore the overlap of folate receptor alpha expression in ovarian cancers, potentially aiding in treatment matching and sequencing [5][12] - Another study will utilize multi-omics approaches to understand long-term responses and resistance to immunotherapy in NSCLC [5][12] Clinical Trials and Presentations - ABBV-969 data will be presented in an oral session on April 27, 2025, highlighting its potential as a first-in-class treatment for advanced prostate cancer [3][4] - ABBV-514 data will be showcased in a poster presentation on April 29, 2025, focusing on its ability to deplete immunosuppressive Tregs in tumors [3][4] - Additional presentations will cover various aspects of cancer research, including germline variants and their association with patient prognosis [5][12]

Financial Data and Key Metrics Changes - The company ended the year with a cash balance of $4.6 million, with cash used in operations for Q4 2024 at $1.7 million and for the full year at $9.6 million, compared to $3 million and $15.8 million for the same periods in 2023, reflecting efforts to contain spending while advancing programs [27][28] - The net loss for the year ended 2024 was $10.8 million or $2.86 per share, compared to a net loss of $22.5 million or $6.54 per share in the prior year [28] Business Line Data and Key Metrics Changes - The company made significant progress in its clinical programs, particularly with the iNKT cell therapy, which has shown effectiveness in treating solid tumors and immune-driven diseases [11][12] - The collaboration with Autonomous Therapeutics aims to enhance the efficacy of iNKT cell therapy by integrating their encrypted RNA technology, targeting metastatic cancer with greater precision [9][10] Market Data and Key Metrics Changes - The company presented data at major conferences, demonstrating that its iNKT cell therapy enhances immune activation and overcomes resistance in challenging cancers, including gastric cancer [12][13] - The Phase 1 study of AgenT-797 in patients with severe acute respiratory distress showed an 80% survival rate, significantly higher than the 10% survival rate of in-hospital controls [20][21] Company Strategy and Development Direction - The company is focused on delivering scalable, durable, and effective allogeneic iNKT cell therapy to patients, with plans to advance multiple clinical programs in 2025, including gastric cancer and GvHD [5][31] - The addition of Dr. Robert Kadlec to the Board of Directors is expected to enhance the company's strategic depth in biodefense and pandemic preparedness [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's momentum entering 2025, highlighting a differentiated technology and a clear plan to reach the next value inflection point [26][32] - The company remains committed to operational efficiency and fiscal responsibility while advancing its innovative therapies [32] Other Important Information - The company has received probable funding from the National Institute of Allergy and Infectious Diseases (NIAID) to explore the activity of 797 in acute GvHD, with plans for a Phase 1 trial [23][24] - The company is advancing its PRAME-TCR program, which targets intracellular tumor antigens, demonstrating high specificity and potent tumor killing [15][18] Q&A Session Summary Question: Status of the Phase 2 study and focus for 2025 - Management confirmed that the majority of patients are enrolled in the Phase 2 study for gastric cancer, with data expected in the second half of the year, and emphasized the importance of advancing both gastric cancer and GvHD programs in 2025 [36][41] Question: KOL investigator feedback and potential for approval - Management noted positive feedback from key opinion leaders and emphasized the goal of accumulating data to demonstrate clinical benefits, with plans for regulatory discussions [47][53] Question: Timing of funding for GvHD study and cash runway - Management indicated that funding for the GvHD study is fluid but expressed optimism about securing it, while confirming that the company has cash runway through the end of 2025 [66][78]

Core Viewpoint - Alumis Inc. announced positive 52-week data from the open-label extension of its Phase 2 STRIDE clinical trial for ESK-001, indicating its potential as an effective oral therapy for moderate-to-severe plaque psoriasis [1][2][3] Group 1: Clinical Trial Results - Patients receiving 40 mg of ESK-001 twice daily showed sustained clinical responses at Week 52, with PASI 90 at 61.3% compared to 52.4% at Week 12, and PASI 100 at 38.8% compared to 26.8% [2] - At Week 52, 81.3% of patients reported improved control of itch (NRS≤4) and 61.3% reported enhanced quality of life (DLQI0/1) [2] - ESK-001 was well tolerated at Week 52, with safety profiles consistent with earlier data and no new safety findings reported [2][6] Group 2: Drug Profile and Mechanism - ESK-001 is a next-generation oral TYK2 inhibitor designed to correct immune dysregulation related to proinflammatory mediators such as IL-23, IL-17, and type 1 interferon [3][4] - The drug's selective targeting aims to maximize inhibition while minimizing off-target effects, positioning it as a potential best-in-class treatment for plaque psoriasis [4][6] Group 3: Ongoing and Future Studies - The Phase 3 ONWARD clinical program is currently underway, consisting of two parallel trials (ONWARD1 and ONWARD2) with approximately 840 patients each, comparing ESK-001 to placebo and apremilast [5][7] - Topline data from the ONWARD studies is expected in the first quarter of 2026, with ongoing patient enrollment for moderate-to-severe psoriasis [4][5] Group 4: Broader Development Strategy - Alumis is also developing a once-daily modified release formulation of ESK-001 and evaluating its application in systemic lupus erythematosus through the LUMUS Phase 2b trial [8] - The company leverages a precision data analytics platform to explore ESK-001's potential in other immune-mediated conditions, aiming to build a diverse pipeline of therapeutic options [9]

Table of Contents As filed with the Securities and Exchange Commission on January 29, 2025 Registration No. 333-284164 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 82-2635018 (I.R.S. Emplo ...

Table of Contents As filed with the Securities and Exchange Commission on January 7, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 82-2635018 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) ...

Summary of InMed Pharmaceuticals (INM) Update / Briefing Industry Overview - The discussion centers around the Alzheimer's disease research and development landscape, highlighting the recent advancements in disease-modifying therapies and the challenges faced in clinical trials and drug development [6][7][15]. Key Points and Arguments Advances in Alzheimer's Research - There has been a significant increase in understanding Alzheimer's disease over the past decade, with the first disease-modifying therapies launched in the U.S., Japan, and China [6][7]. - The removal of amyloid from the brains of patients has been achieved, impacting tau levels and disease progression, although the average clinical impact remains limited [15][16][18]. Challenges with Mouse Models - Current mouse models primarily focus on amyloidosis and tauopathy, which do not fully replicate the complexity of Alzheimer's disease [8][9][10]. - The efficacy of treatments is often tested in younger mice, which may not accurately reflect the disease's progression in older adults [10][11]. - Advanced-stage models are necessary to better understand the safety and efficacy of treatments [11][13]. Importance of Biomarkers - The selection of patients for clinical trials has evolved from clinical criteria to biomarker-based criteria, improving the ability to demonstrate clinical efficacy [21][22]. - There is a need for better biomarkers for neuroinflammation, which is still in early development compared to amyloid biomarkers [47][48]. Neuroinflammation as a Target - Chronic neuroinflammation is recognized as a significant factor in Alzheimer's disease, with potential drug targets being explored [32][33][36]. - InMed's compound, INM901, shows promise in modulating neuroinflammation and promoting neurogenesis, with positive results in animal studies [30][51][52]. Diversity in Clinical Trials - Current clinical trials have been criticized for lacking racial and ethnic diversity, which may affect the understanding of drug efficacy across different populations [18][20][60]. Future Directions - The panelists express optimism about the future of Alzheimer's research, emphasizing the need for combination therapies and the potential for repurposing existing drugs [41][65]. - The goal is to transform Alzheimer's from a terminal disease to a chronic condition, improving the quality of life for patients [88][89]. Other Important Content - The discussion highlights the iterative learning process in selecting patients for trials based on biomarkers rather than solely on clinical diagnosis [21][22]. - The role of inflammation in Alzheimer's is complex, with both beneficial and harmful effects depending on the disease stage [40][76]. - The importance of accurate diagnosis and the distinction between Alzheimer's disease and dementia is emphasized [103]. This summary encapsulates the key discussions and insights from the InMed Pharmaceuticals update, focusing on the current state and future directions of Alzheimer's disease research and treatment.

As filed with the Securities and Exchange Commission on April 17, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 87-2147982 (State or other jurisdiction of incorporation or organization) William N. Haddad Arif Soto Venable LLP 151 W. 42 Street, Floor 49 New York, NY 10036 (212) 307-5500 Approximate ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 24, 2024. Registration No. 333-276664 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) 2834 Delaware (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) David Happel President ...

Table of Contents As filed with the Securities and Exchange Commission on December 11, 2023 Registration No. 333-275870 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.1 To FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTOSE BIOSCIENCES INC. (Exact Name of Registrant As Specified In Its Charter) (State or other jurisdiction of incorporation or organization) Canada 2836 98-1136802 (Primary Standard Industrial Classification Code Number) (I.R.S. Employe ...