OnKure Therapeutics FY Conference Summary Company Overview - **Company**: OnKure Therapeutics - **Ticker**: NasdaqGM:OKUR - **Location**: Boulder, Colorado - **Focus**: Development of selective PI3K alpha inhibitors, particularly targeting mutant forms of the enzyme [2][4] Key Product: OKI-219 - **Description**: OKI-219 is the most advanced candidate targeting the PI3K alpha H1047R mutation, which represents approximately two-thirds of mutations in patient populations with mutated PI3K alpha [3][4] - **Selectivity**: OKI-219 exhibits greater than 80-fold selectivity for mutant over wild type PI3K alpha, allowing for effective dosing without significant side effects associated with wild type inhibition [5][7] - **Comparison with Competitors**: Other approved drugs like alpelisib show no selectivity, while inavolisib has only four-fold selectivity. OKI-219's high selectivity minimizes common side effects such as hyperglycemia and rash [6][7] Clinical Studies - **Current Studies**: OKI-219 is involved in three clinical studies: - Monotherapy basket study - Doublet study in combination with fulvestrant for breast cancer - Triplet studies in ER-positive and HER2-positive breast cancer [11][12] - **Data Reporting**: Efficacy data from these studies is expected to be reported in the first quarter of 2026 [13][25] Differentiation and Market Strategy - **Differentiation**: The company aims to differentiate itself by moving into front-line therapy with a well-tolerated regimen, focusing on tolerability and combinability with existing treatments [12][20] - **Target Patient Population**: The HER2-positive breast cancer cohort is noted to have a significant opportunity, despite a lower mutation frequency compared to ER-positive breast cancer [18] CNS Penetration - **Importance**: OKI-219 has a high brain-to-plasma ratio (Kp,uu of 0.6), which is crucial for treating cancers with CNS involvement, particularly HER2-positive breast cancer [15][16] Future Development Plans - **Pan-PI3K Mutant Inhibitor**: The company is also developing a pan-PI3K mutant inhibitor with greater than 10-fold selectivity across all mutants, with plans to report on these developments in the first quarter of 2026 [32] - **Regulatory Strategy**: The company is focused on minimizing risks and ensuring that their drugs do not lead to significant drug-drug interactions (DDIs) with existing therapies [34][35] Conclusion - **Overall Strategy**: OnKure Therapeutics is positioning itself to compete effectively in the oncology market by focusing on high selectivity, tolerability, and strategic partnerships in clinical studies, with a clear timeline for data disclosure and future development [31][32]

Theravance Biopharma Third Quarter 2025 Financial Results and Business Update November 10, 2025 THERAVANCE BIOPHARMA®, THERAVANCE®, the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third-party trademarks used herein are the property of their respective owners. © 2025 Theravance Biopharma. All rights reserved. Forward Looking Statements Examples of such statements include statement ...

Nasdaq: HIT 22,40,80 30,109,175 210,20,125 This Presentation has been prepared by the Company solely for informational purposes. The information included herein in this presentation has not been independently verified. No representations, warranties or undertakings, express or implied, are made by the Company or any of it' s affiliates, advisers or representatives or the underwriters as to, and no reliance should be placed upon, the accuracy, fairness, completeness or correctness of the information or opini ...

Q3 2025 Results November 10th, 2025 Green Dot Corporation Safe Harbor Statement This presentation contains forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, among other things, statements regarding Green Dot's business and pipeline momentum, revenue and division trends, timing and impact of partner launches and 2025 guidance and outlook, and other future events that involve risks and uncertainties. A ...

Summary of Avalo Therapeutics FY Conference Call Company Overview - **Company**: Avalo Therapeutics (NasdaqCM:AVTX) - **Location**: Near Philadelphia - **New Asset**: AVTX-009, a high affinity human anti-IL-1 beta monoclonal antibody targeting hidradenitis suppurativa (HS) [2][3] Key Points Product Development - **Background**: AVTX-009 was originally developed by Lilly for type 2 diabetes, showing a moderate effect size of 0.25-0.3 grams reduction in hemoglobin A1C, but was not pursued further [2][3] - **Acquisition**: Avalo acquired the asset after it was not advanced by previous owners [3] - **Funding**: The company raised $185 million in 2024 to support its operations and trials [3] - **Lotus Trial**: A phase 2b proof of concept study for AVTX-009 is fully enrolled, with data expected in mid-2026 [4] Mechanism of Action - **IL-1 Beta Role**: IL-1 beta is a master regulator of the immune system, crucial in the inflammatory response in HS lesions [5][6] - **Cytokine Levels**: IL-1 beta is the most abundant cytokine in HS lesions, making it a prime target for treatment [7] Comparison with Competitors - **AbbVie’s Lutikizumab**: A bispecific anti-IL-1 beta and anti-IL-1 alpha drug with a shorter half-life and lower affinity for IL-1 beta compared to AVTX-009 [11][12] - **Efficacy Data**: AbbVie reported a drug effect size of approximately 46% in a severe HS population, which Avalo aims to exceed with its higher affinity drug [13][15] Trial Design and Expectations - **Placebo Response**: The Lotus trial is designed to mitigate placebo responses, with a conservative estimate of a 20% placebo rate based on historical data [19][20] - **Patient Demographics**: The trial includes a mix of biologically experienced patients, with a higher proportion of TNF and IL-17 failures compared to competitors [25][26] Future Indications - **Exploration Beyond HS**: Avalo is interested in expanding indications to include crystal arthropathies, such as gout, in addition to other inflammatory conditions [30][31] Financial Health - **Balance Sheet**: Avalo has $115 million available, sufficient to fund operations through data release and into 2028, with plans to raise funds for phase three trials [33] Additional Insights - **Trial Management**: The company emphasizes rigorous training for investigators to ensure objective assessments and accurate data collection [27][28] - **Statistical Approach**: Avalo plans to handle non-responder imputation scientifically, contrasting with other companies' methods that may artificially lower efficacy results [29]

As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. You should understand that it is not possible to predict or identify all such factors. We operate in a competitive and rapidly changing environment. New factors emerge from time to time, and it is not possible to predict the impact of all of these factors on our business, financial condition or results of operations. Furthermore, if our forward-looking statements prove to be ...

This presentation includes adjusted EBITDA, a non-GAAP financial measure, which supplements the Company's financial measures prepared in accordance with GAAP. This non-GAAP financial measure is not intended to supersede or replace the Company's GAAP results. Net Income, the most directly comparable GAAP financial measure, and a detailed reconciliation between Net Income and Adjusted EBITDA for the third quarter of 2025 are included in the Appendix to this presentation. Earnings Call Supplemental Slides Thir ...

THIRD QUARTER 2025 BUSINESS UPDATE This communication contains "forward-looking statements" that are not historical facts, and involve risks and uncertainties that could cause actual results of AST SpaceMobile to differ materially from those expected and projected. These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes," "estimates," "anticipates," "expects," "intends," "plans," "may," "will," "would," "potential," "projects," "predicts," ...

Q3 2025 Disclaimer Forward-Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our future results of operations and financial position, our operational performance, our anticipated growth and business strategy, our future capital expenditures and debt service obligations, the projected costs, prospects and plans and objectives of management for ...

3Q 2025 Earnings Presentation November 2025 FORWARD- LOOKING STATEMENTS Statements made in this presentation regarding American Public Education, Inc. or its subsidiary institutions ("APEI" or the "Company") that are not historical facts are forward-looking statements based on current expectations, assumptions, estimates and projections about APEI and the industry. In some cases, forward looking statements can be identified by words such as "anticipate," "believe," "seek," "could," "estimate," "expect," "in ...