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Viant(DSP) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
SAFE HARBOR This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words such as "guidance," "believe," "expect," "estimate," "project," "plan," "will," or words or phrases with similar meaning. Forward-looking statements s ...
Tenax Therapeutics (NasdaqCM:TENX) FY Conference Transcript
2025-11-10 22:00
Tenax Therapeutics Conference Call Summary Company Overview - **Company**: Tenax Therapeutics (NasdaqCM:TENX) - **Focus**: Development of Levosimendan for the treatment of pulmonary hypertension with preserved ejection fraction (PH-HFpEF) [2][3] Industry Context - **Market Size**: Estimated prevalence of PH-HFpEF in the U.S. is about 2 million patients, with an additional 2 million in Europe, indicating a significant market opportunity [12][13] - **Unmet Need**: No approved therapies for PH-HFpEF exist, and some existing treatments have been harmful, highlighting a substantial unmet medical need [12][13] Core Points and Arguments - **Drug Development**: - Levosimendan is currently in phase three trials, with the first trial ongoing and a second trial expected to start soon [2][25] - The drug has been approved in over 60 countries for IV use but has not been previously studied for HFpEF in the U.S. [6][7] - Tenax's approach involves treating volume overload rather than directly targeting left ventricular compliance, which has been a common failure point in past drug developments [4][5] - **Trial Design**: - The phase two HELP trial demonstrated significant improvements in hemodynamics, specifically in wedge pressure and central venous pressure, without affecting contractility [15][16] - The primary endpoint for the phase three trials is the six-minute walk distance, which is a recognized endpoint for approval in pulmonary hypertension [17][27] - **Licensing and Rights**: - Tenax has secured a worldwide license for Levosimendan, allowing for various formulations, including oral and modified oral forms [9] - **Patient Transition**: - Transition from IV to oral formulation has shown positive outcomes, with patients reporting improved symptoms and walking distances [20][24] Additional Important Insights - **Regulatory Pathway**: The use of six-minute walk as an endpoint is seen as a straightforward regulatory path for approval, especially given the lack of existing effective therapies [17][27] - **Market Research**: Feedback from key opinion leaders (KOLs) indicates that the three-times-a-day dosing of the oral formulation is not seen as a barrier to patient compliance due to the significant symptom relief it provides [32][33] - **Future Opportunities**: There are plans for lifecycle management, including potential dosing changes to improve market penetration and patient adherence [33][34] Financial Position - **Cash Runway**: As of the last reported quarter, Tenax had over $100 million in cash, which is expected to support ongoing research and development efforts [35]
The RealReal(REAL) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
Q3 2025 Financial Results November 10, 2025 Q3 2025 FINANCIAL RESULTS Safe Harbor/Disclosure Statement These materials contain forward-looking statements relating to, among other things, the future performance of The RealReal that are based on the company's current expectations, forecasts and assumptions and involve risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expect," "plan," "anticipate," "target," "contemplat ...
Repay (RPAY) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
Exhibit 99.2 Q3 2025 Earnings Supplement November 2025 Disclaimer 1 Repay Holdings Corporation ("REPAY" or the "Company") is required to file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission ("SEC") Such filings, which you may obtain for free at the SEC's website at http://www.sec.gov, discuss some of the important risk factors that may affect REPAY's business, results of operations and financial condition. Forward-Looking Statements T ...
FibroGen(FGEN) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
November 10, 2025 FibroGen Reports Third Quarter 2025 Financial Results Forward-Looking Statements This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, convenience, and potential clinical or commercial success of F ...
Septerna (NasdaqGM:SEPN) FY Conference Transcript
2025-11-10 22:00
Summary of Septerna's Conference Call Company Overview - **Company**: Septerna - **Focus**: G protein-coupled receptors (GPCRs) and small molecule discovery using the Native Complex platform - **Financial Position**: Well-capitalized with an operating cash runway into at least 2029 [2][2][2] Key Programs 1. **SEP479 Program** - **Target**: Parathyroid hormone receptor agonist for hyperparathyroidism - **Clinical Development**: Anticipated entry into the clinic in the first half of next year [3][3][9] - **Pharmacodynamics**: Demonstrated ability to normalize serum calcium and phosphate levels in preclinical studies with low dosing (0.15 mg/kg) [7][7][8] - **Safety Profile**: Improved pharmaceutical properties compared to previous candidate SEP786, which was discontinued due to safety issues related to bilirubin levels [6][14][15] - **Half-Life**: Predicted human half-life of 40-80 hours, supporting once-daily dosing [7][17][17] 2. **SEP631 Program** - **Target**: MRGPRX2 negative allosteric modulator for mast cell-driven diseases, including chronic spontaneous urticaria - **Clinical Development**: Currently in phase one trial, with data expected in early 2026 [9][12][25] - **Pharmacodynamics**: Demonstrated complete inhibition of extravasation in preclinical models [11][11] - **Differentiation**: Unique profile as an insurmountable negative allosteric modulator, potentially offering a long duration of action [10][19] 3. **Thyroid-Stimulating Hormone Receptor Program** - **Target**: Graves' disease and thyroid eye disease - **Market Opportunity**: Significant unmet need with a large market size; current treatments are outdated [26][26][27] - **Mechanism**: Utilizing an insurmountable negative allosteric modulator approach to inhibit receptor activation by various antibodies [27][28] Collaborations and Financials - **Collaboration with Novo Nordisk**: Announced a significant collaboration in May, including $195 million upfront and full support for R&D costs [4][4] Market Context and Competitive Landscape - **Mast Cell Indications**: Potential to target multiple mast cell-driven diseases, with chronic spontaneous urticaria as the initial focus [21][21] - **Competitive Landscape**: Acknowledgment of a crowded market for chronic spontaneous urticaria treatments, with a focus on differentiating SEP631 from existing therapies [22][22][19] Future Outlook - **Pipeline Expansion**: The platform has broader applications for GPCRs, with potential for a deep pipeline of products targeting various therapeutic areas [29][30] - **Clinical Trials**: Plans to initiate trials for SEP631 in chronic spontaneous urticaria following successful phase one results [25][25] Conclusion - **Overall Sentiment**: Positive outlook on the progress of Septerna's programs, with a focus on advancing clinical development and addressing significant market needs in the biopharma space [30][30]
OnKure Therapeutics (NasdaqGM:OKUR) FY Conference Transcript
2025-11-10 22:00
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(TBPH) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
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 ...
Health In Tech Inc(HIT) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
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 ...
Green Dot(GDOT) - 2025 Q3 - Earnings Call Presentation
2025-11-10 22:00
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 ...