Financial Data and Key Metrics Changes - The company reported a net loss of approximately $5.9 million for Q4 2024, compared to a net loss of approximately $4.2 million in Q4 2023, reflecting a loss per share increase from $0.39 to $0.54 [62] - For the full year 2024, R&D expenses were approximately $16.1 million, up from approximately $11.9 million in 2023, primarily due to increased research studies and payroll expenses [63] - The total cash position as of December 31, 2024, was approximately $24 million, which is expected to fund operations for at least 12 months [65] Business Line Data and Key Metrics Changes - All clinical stage drug candidates are now in Phase 1 and Phase 2 trials, with significant progress reported in the clinical pipeline and AI platform [12][14] - The Phase 2 asset LP-300 has seen accelerated enrollment, particularly in Japan and Taiwan, where the incidence of non-small cell lung cancer among never smokers is significantly higher [17][70] - The lead cohort for LP-300 achieved an 86% clinical benefit rate and a 43% objective response rate in never smoker non-small cell lung cancer patients [15] Market Data and Key Metrics Changes - The company is expanding its geographic strategy to Japan and Taiwan, where 33% to 40% of non-small cell lung cancer cases occur in never smokers, compared to just 15% in the U.S. [17] - The market potential for LP-300 is estimated to be between $4 billion to $5 billion annually, with a growing opportunity in the targeted population [14] Company Strategy and Development Direction - The company emphasizes the innovative use of AI and machine learning to transform oncology drug discovery and development, aiming for significant returns for investors and patients [8] - The strategic expansion into Asia is expected to enhance enrollment rates and generate robust data sets for clinical trials [17][70] - The company is focused on advancing its product candidates and pipeline, with a strong emphasis on R&D expenses exceeding G&A expenses [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative potential of AI in drug development, highlighting the efficiency and cost-effectiveness of their approach [68][76] - The company anticipates multiple value-creating milestones throughout the year, with the potential to deliver transformative therapies for patients with limited treatment options [60][87] - Management acknowledged the need for substantial additional funding in the near future to support ongoing operations and clinical trials [65] Other Important Information - The company has received two FDA Fast Track designations for LP-184 in glioblastoma and triple-negative breast cancer, which could expedite clinical development timelines [18] - The RADR platform has expanded beyond $100 billion in oncology-specific data points, enabling sophisticated analysis and biomarker discovery initiatives [56][58] Q&A Session Summary Question: How is the pace and quality of enrollment in Asia compared to the U.S.? - The enrollment pace in Asia is about 2x to 4x faster than in the U.S., with significant output observed in recent months [90] Question: What are the opportunities for ADCs that substitute the toxic payload with another immunotherapy? - The design of multi-payload ADCs is seen as a future direction, with potential for combining immunomodulating agents with toxic payloads [91][92] Question: What should be expected from the HARMONIC update later this year? - The company expects to have a significant amount of data from enrolled patients, with key insights anticipated by mid to late Q2 [96][100] Question: When will results for LP-184 be provided? - The results for LP-184 have been delayed due to higher dose levels being reached, with therapeutic levels of efficacy beginning to be observed [107] Question: When will the pediatric trial for STAR begin? - The company is close to finalizing a protocol for pediatric brain cancers and expects to launch the trial mid to late this year [111]

Financial Data and Key Metrics Changes - The company reported a net loss of approximately $5.9 million for Q4 2024, compared to a net loss of approximately $4.2 million in Q4 2023, reflecting an increase in loss per share from $0.39 to $0.54 [62] - For the full year 2024, R&D expenses were approximately $16.1 million, up from approximately $11.9 million in 2023, primarily due to increased research studies and payroll expenses [63] - The total cash position as of December 31, 2024, was approximately $24 million, which is expected to fund operations for at least 12 months [65] Business Line Data and Key Metrics Changes - All clinical stage drug candidates are now in Phase 1 and Phase 2 trials, with significant progress reported in the clinical pipeline and AI platform [12][14] - The Phase 2 asset LP-300 has seen accelerated enrollment, particularly in Japan and Taiwan, where the incidence of non-small cell lung cancer among never smokers is significantly higher [17][70] - The lead cohort for LP-300 achieved an 86% clinical benefit rate and a 43% objective response rate in never smoker non-small cell lung cancer patients [15] Market Data and Key Metrics Changes - The market potential for LP-300 is estimated to be between $4 billion to $5 billion annually, with a growing opportunity due to the increasing incidence of non-small cell lung cancer in specific populations [14] - The market potential across indications for LP-184 exceeds $10 billion annually, addressing over 150,000 patients with limited therapeutic options [20] Company Strategy and Development Direction - The company is focused on leveraging AI and machine learning to transform oncology drug discovery and development, aiming for significant returns for investors and patients [8] - The strategic expansion into Asia is expected to enhance enrollment rates and generate robust data sets, positioning the company for compelling readouts in 2025 [17][70] - The company is developing an agentic AI platform that will enhance drug development efficiency and precision, potentially reducing preclinical development costs by 60% to 80% [80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative potential of AI in oncology, emphasizing the importance of data-driven approaches in drug development [87] - The company anticipates multiple value-creating milestones throughout the year, with a focus on delivering transformative therapies for patients with limited treatment options [60] Other Important Information - The company has received two FDA Fast Track designations for LP-184 in glioblastoma and triple negative breast cancer, which could expedite clinical development timelines [18] - The RADR platform has expanded beyond $100 billion oncology-specific data points, enabling sophisticated analysis that traditional approaches cannot match [56] Q&A Session Summary Question: How is the pace and quality of enrollment in Asia compared to the U.S.? - The pace of enrollment in Asia is about 2x to 4x faster than in the U.S., with significant output observed in recent months [90] Question: What are the opportunities for ADCs that substitute the toxic payload with another immunotherapy? - The company sees potential in using small molecule immunomodulating agents in ADCs, and there is ongoing exploration of multi-payload designs [91][92] Question: What should be expected in the upcoming HARMONIC update? - The company expects to have a significant amount of data from enrolled patients, with key readouts anticipated in mid to late Q2 [100] Question: What is the status of LP-184 data? - The LP-184 data was delayed due to higher dose levels being reached, which has extended the timeline for results [107] Question: When will pediatric trials for STAR begin? - The company is close to finalizing a protocol for pediatric brain cancers and expects to launch trials mid to late this year [111]

Industry Overview - Artificial Intelligence (AI) and Machine Learning (ML) are crucial in precision oncology, enhancing decision-making through the analysis of large datasets and digital pathology [1] - The global AI in oncology market is valued at $1.92 billion in 2023, with a projected CAGR of 29.4%, reaching $11.52 billion by 2030, indicating rising investor interest [3] AI Initiatives and Developments - The National Institutes of Health (NIH) is evaluating the PRIMED-AI initiative to enhance disease diagnosis and treatment through coordinated AI/ML efforts [2] - AI models developed by NIH aim to predict cancer patients' responses to therapies, showcasing the growing integration of AI in healthcare [2] Key Players in AI-Driven Precision Oncology - NVIDIA is a significant player, providing powerful GPUs essential for AI models in imaging and drug development [5] - Palantir's Foundry platform enables comprehensive data analysis across laboratories, enhancing research capabilities [5] - Google's DeepMind, IBM Watson Health, and Microsoft's AI initiatives are also shaping the competitive landscape in healthcare [6] Investment Opportunities - BioXcel Therapeutics utilizes its proprietary AI platform, NovareAI, to expedite drug development, with a long-term expected earnings growth rate of 37.9% and projected revenue growth of 71.2% by 2025 [8][9] - Tempus AI enhances precision medicine through its algorithmic test platform, with a long-term expected earnings growth rate of 42% and projected revenue growth of 78.4% by 2025 [10][12] - Quest Diagnostics is integrating AI to improve operational efficiency and has acquired PathAI Diagnostics to advance digital pathology innovations, with a long-term expected earnings growth rate of 8.2% [13][14]

Company Overview - Aadi Bioscience, Inc. is a precision oncology company focused on delivering improved therapies for difficult-to-treat cancers [2] Financial Results Announcement - Aadi will host a webcast on March 19, 2025, to discuss its fourth quarter and full-year 2024 financial results [1] - The financial results will be accessible on the "Investors & News" page of Aadi's website [1]

As filed with the Securities and Exchange Commission on December 4, 2023. 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 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2834 | 87-2147982 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Numbe ...

As filed with the Securities and Exchange Commission on October 30, 2023. Registration No. 333-___________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 2834 87-2147982 (I.R.S. Employer Identification No.) 24 School Street, 2nd Floor Bos ...