Summary of Edgewise Therapeutics Conference Call Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Event**: 2026 Healthcare Innovation Conference - **Key Speaker**: Behrad Derakhshan, Chief Operating Officer Key Points Industry and Product Focus - Edgewise is focused on developing treatments for hypertrophic cardiomyopathy (HCM) and Becker muscular dystrophy, with significant unmet needs in these areas [5][6] - The company is preparing for a Phase 3 readout in its Becker program with sevasemten, aiming to launch the first drug for Becker patients [5] Clinical Trials and Data - The company is excited about the upcoming Part D data related to obstructive and non-obstructive HCM, emphasizing the rigorous data quality over competitor timelines [16][17] - Changes in screening criteria for clinical trials have been implemented to reduce AFib observations, including extending the look-back period for patient history and enhancing cardiac monitoring [11][12][13] - The company reported no AFib burden during extensive screening, indicating progress in addressing previous concerns [13] Competitive Landscape - Edgewise aims to differentiate its drug by allowing physicians to dose optimize without the need for rigorous echo monitoring, which is a limitation for current treatments [26][27][36] - The company believes there is still room for improvement in the obstructive population, particularly outside of centers of excellence where community physicians manage heart failure [24][25] Future Plans and Regulatory Considerations - Edgewise plans to initiate Phase 3 trials in the fourth quarter of 2026 and is preparing to engage with the FDA regarding registration studies [46][49] - The company is considering the potential for a synergistic use of its drug with current treatments in the obstructive setting, although it may lead to a switch rather than combination therapy [47] Commercial Strategy - Edgewise is building a commercial organization in anticipation of positive data, aiming for a broad label to treat patients diagnosed during adolescence [60][62] - The company is focused on demonstrating the long-term benefits of its drug to justify orphan drug pricing and ensure patient retention [59][60] Other Programs - The company is also advancing EDG-15400, with data expected in the second quarter of 2026, targeting heart failure with preserved ejection fraction (HFpEF) [48][49] - The Grand Canyon study for sevasemten is on track, with a low dropout rate indicating strong patient retention [53][54] Market Positioning - Edgewise is positioning itself to capture a significant market share in HCM and Becker muscular dystrophy by addressing unmet needs and simplifying treatment protocols for physicians [38][60] Conclusion - Edgewise Therapeutics is poised for significant developments in the coming year, with a focus on rigorous data quality, innovative treatment approaches, and a strong commercial strategy to meet the needs of patients with HCM and Becker muscular dystrophy [5][6][60]

Summary of Conference Call with Boundless Bio Company Overview - **Company**: Boundless Bio - **CEO**: Zach Hornby Industry Insights - **Focus**: Oncology and cancer treatment - **Unmet Need**: Significant unmet need exists for patients with oncogene amplification, which accounts for approximately 25% of all cancer cases. These patients currently lack effective standard care and have worse survival outcomes compared to those with tumors driven by gene fusions or point mutations [5][3][4]. Core Concepts Discussed - **ecDNA**: - Stands for extrachromosomal DNA, which is a unique feature of cancer cells that allows for genomic diversity and tumor survival [7][9]. - Found in 15%-17% of tumors at diagnosis, ecDNA plays a critical role in oncogene amplification [10]. - **Spyglass Platform**: - A platform developed by Boundless Bio to study ecDNA and identify potential therapeutic targets. It includes hundreds of in vitro models and thousands of in silico models to analyze the effects of pharmacological inhibition on ecDNA-positive and negative tumor models [10][11]. Product Development - **BBI-940**: - A novel kinesin-targeting compound developed through the Spyglass platform. It has recently received IND acceptance and is set to enter Phase 1 clinical trials [12][13]. - The compound is designed to degrade a kinesin that is essential for the movement of ecDNA during cell division, which is not essential in healthy cells, potentially leading to a favorable therapeutic index [16][13]. Clinical Trial Design - **Phase 1 Study**: - The study will enroll patients with two subtypes of breast cancer: ER-positive, HER2-negative and a specific subset of triple-negative breast cancer (TNBC LAR) [24][25]. - The trial will focus on pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability, with an aim to achieve 70% target degradation for efficacy [34][40]. - FGFR1 amplification will be a key biomarker for patient selection, particularly in ER-positive breast cancer, where it is associated with rapid resistance to existing therapies [26][27]. Market Potential - **Breast Cancer**: - The breast cancer market is significant, and the company anticipates good enrollment for the trial due to the large patient population [40]. - FGFR1 amplification is found in about 15% of ER-positive breast cancer patients at baseline, increasing to 30% upon resistance to treatment [30][26]. Future Directions - **Additional Opportunities**: - Beyond breast cancer, Boundless Bio is exploring other tissue-specific cancers that may respond to BBI-940, with ongoing preclinical profiling [41]. - **Pipeline Expansion**: - The company has identified approximately a dozen additional targets related to ecDNA biology for future drug discovery efforts, contingent on the success of the current clinical study and available resources [42][43]. Financial Outlook - **Cash Runway**: - Boundless Bio projects its balance sheet will extend into the second half of 2028, allowing for potential capital-raising events based on clinical data generated by mid-next year [43]. Conclusion - The conference highlighted Boundless Bio's innovative approach to addressing significant unmet needs in cancer treatment through the development of BBI-940 and the utilization of the Spyglass platform to target ecDNA-driven oncogene amplifications. The company is positioned to make impactful advancements in oncology, particularly in breast cancer, while maintaining a focus on financial sustainability and future growth opportunities.

Financial Data and Key Metrics Changes - Pre-tax income for Q4 2025 was $113 million, down from $134 million in Q4 2024, with full-year pre-tax income at $561 million compared to $584 million in 2024, reflecting a decline of 4% [3] - Net income for Q4 2025 was $81 million, or $8.65 per share, compared to $111 million, or $11.56 per share in Q4 2024; full-year net income was $419 million, or $44.44 per share, down from $462 million, or $48.22 per share in 2024 [3][4] Business Line Data and Key Metrics Changes - Petroleum Additives sales for Q4 2025 were $585 million, down from $626 million in Q4 2024; operating profit for this segment was $107 million, compared to $136 million in the same period last year [4][5] - For the full year, Petroleum Additives sales were $2.5 billion, down from $2.6 billion in 2024, with operating profit at $520 million compared to $592 million in 2024 [6] - Specialty Materials sales for Q4 2025 were $49 million, up from $27 million in Q4 2024, with operating profit increasing to $7 million from about $2 million [7][8] - Full-year Specialty Materials sales were $182 million, compared to $141 million in 2024, with operating profit rising to $47 million from $17 million [9] Market Data and Key Metrics Changes - Shipments in the Petroleum Additives segment declined by 6% in Q4 2025 and 4.9% for the full year, attributed to market softness and strategic decisions to manage profitability [5][6] Company Strategy and Development Direction - The company is focused on investing in technology, optimizing inventory levels, and improving portfolio profitability, with a commitment of approximately $1 billion towards expanding capacity in the Specialty Materials segment [9][10] - The company aims to promote long-term value for shareholders and customers, emphasizing a safety-first culture, customer-focused solutions, and technology-driven products [11] Management's Comments on Operating Environment and Future Outlook - Management noted challenges from ongoing inflation, tariffs, and market softness impacting shipments, but expressed confidence in the strength of the petroleum additives and specialty materials segments [6][10] - The company generated solid cash flows in 2025, allowing for shareholder returns through share repurchases and dividends, while also reducing total debt by $88 million [10] Other Important Information - The effective tax rate increased in 2025 compared to 2024, significantly impacting net income and EPS [4] - The company reported a net debt to EBITDA ratio of 1.1 times as of December 31, 2025, slightly down from 1.2 at the end of 2024 [10] Q&A Session Summary - No specific questions or answers were provided in the content, indicating that the conference call concluded without a Q&A segment [12]

Summary of Climb Bio's Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Autoimmune diseases with two antibodies in clinical development Key Points Upcoming Milestones - Climb Bio has five clinical data readouts scheduled for this year - Monoclonal antibody targeting CD19: - Data on subcutaneous (subQ) formulation in healthy volunteers expected in the first half of the year - Initial data from Phase 1b studies in Immune Thrombocytopenic Purpura (ITP) and Systemic Lupus Erythematosus (SLE) in the second half - Initial data from Phase 2 study in Primary Membranous Nephropathy (PMN) also expected in the second half - Second antibody, an APRIL-only antibody for IgA nephropathy, will have data available mid-year [2][3][4] Competitive Landscape - UPLIZNA is currently the only approved CD19 antibody, focusing on rare neuro diseases - Climb Bio's CD19 antibody is believed to have greater affinity and a subQ formulation option, which UPLIZNA lacks [5][7][11] PMN Indication - No approved therapies currently exist for PMN; standard care includes off-label use of rituximab - Rituximab achieves complete renal remission in only 10% of patients after one year and 35% after two years - Climb Bio's Phase 1b study showed a 60% complete remission rate and 100% serological remission in PLA2R antibody-positive patients [14][15][32] Market Opportunity - Approximately 70,000 patients in the U.S. have PMN, with two-thirds requiring therapeutic intervention - Regulatory strategy involves one Phase 3 study with around 150 patients, focusing on proteinuria as the primary endpoint [32][34] ITP and SLE Indications - ITP has a strong rationale for CD19 targeting, with only 20% of refractory patients achieving a durable platelet response - SLE is viewed as a more complex indication, requiring larger pivotal trials; Climb Bio is conducting a parallel study in China for lupus nephritis patients [39][40][41] APRIL Antibody Development - Climb Bio's APRIL-only antibody (CLYM116) features a unique sweeper mechanism, allowing for high-affinity binding and potential for longer half-life - Early studies indicate a two- to threefold longer half-life compared to existing therapies, with better activity in IgA suppression [48][56][60] Financial Position - Climb Bio reported $176 million in cash at the end of Q3, with a runway extending into 2028, covering all planned readouts for the year [93][95] Future Indications - Climb Bio is exploring additional indications for the APRIL antibody, including Sjögren's syndrome, to maximize asset potential [90][91] Conclusion - Climb Bio is positioned to address significant unmet needs in autoimmune diseases with promising clinical data and a strong financial foundation, paving the way for potential market success in the coming years [2][93][95]

Financial Data and Key Metrics Changes - Pre-tax income for Q4 2025 was $113 million, down from $134 million in Q4 2024. For the full year, pre-tax income was $561 million in 2025, compared to $584 million in 2024, a decline of 4% [3] - Net income for Q4 2025 was $81 million, or $8.65 per share, compared to $111 million, or $11.56 per share for Q4 2024. Full year net income for 2025 was $419 million, or $44.44 per share, down from $462 million, or $48.22 per share in 2024 [3][4] Business Line Data and Key Metrics Changes - Petroleum Additives sales for Q4 2025 were $585 million, down from $626 million in Q4 2024. Operating profit for this segment was $107 million in Q4 2025, compared to $136 million in Q4 2024, driven by a 6% decline in shipments and lower selling prices [4][5] - For the full year, Petroleum Additives sales were $2.5 billion in 2025, down from $2.6 billion in 2024. Operating profit for 2025 was $520 million, compared to $592 million in 2024, with shipments down by 4.9% [5][6] - Specialty Materials sales for Q4 2025 were $49 million, up from $27 million in Q4 2024, with operating profit increasing to $7 million from about $2 million in the same period [7] - Full year sales for Specialty Materials were $182 million in 2025, compared to $141 million in 2024, with operating profit rising to $47 million from $17 million [9] Market Data and Key Metrics Changes - The company experienced market softness throughout 2025, impacting shipments and profitability in the Petroleum Additives segment [6] - The Specialty Materials segment showed growth due to higher volume demand at Ampac and the acquisition of Calca Solutions [9] Company Strategy and Development Direction - The company is focused on investing in technology, optimizing inventory levels, and improving portfolio profitability. It has committed approximately $1 billion to expand capacity in the Specialty Materials segment [9] - The company aims to promote long-term value for shareholders and customers, emphasizing a safety-first culture and technology-driven products [11] Management's Comments on Operating Environment and Future Outlook - Management noted challenges from ongoing inflation, tariffs, and market softness impacting shipments. However, they expressed confidence in the performance of the Petroleum Additives and Specialty Materials segments [6][10] - The company generated solid cash flows in 2025, allowing for shareholder returns through share repurchases and dividends, while also reducing total debt [10] Other Important Information - The effective tax rate increased in 2025 compared to 2024, contributing to the decline in net income [4] - The company reported a net debt to EBITDA ratio of 1.1 times as of December 31, 2025, slightly down from 1.2 at the end of 2024 [10] Q&A Session Summary - No specific questions or answers were provided in the content, indicating that the conference concluded without a Q&A segment [12]

Fourth-Quarter 2025 Supplemental Presentation February 12, 2026 including our most recent Forms 8-K, 10-K, and 10-Q. "Organic Revenue" is consolidated revenue before (1) acquisitions and divestitures, (2) adoption of new accounting standards or revisions to accounting practices (accounting changes), and (3) the effect of foreign currency translations. "Adjusted Operating Income (Loss)" is consolidated operating income (loss) excluding (1) intangible amortization expense, (2) the impact of merger, acquisitio ...

Introduction Safe Harbor: Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical facts contained in these slides and the accompanying oral presentation, including statements regarding Yelp Inc.'s ("Yelp" or the "Company") future operations, future performance, expected financial results and future financial position, future revenue and revenue growth rates, future share repurchase activity, strateg ...

Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Focus**: Immunology, specifically food allergies in children - **Lead Product**: Viaskin Peanut, aimed at treating peanut allergies in children aged 1-7 Key Points Product Development and Regulatory Filings - **BLA Filings**: Two Biologics License Applications (BLAs) are planned for 2026: - **Children aged 4-7**: Expected filing by mid-2026 - **Children aged 1-3**: Expected filing by the end of 2026 - **FDA Designation**: The product has received breakthrough designation from the FDA and will seek priority review for the first filing [1][2][3] Market Opportunity - **Prevalence of Food Allergies**: Approximately 670,000 children in the U.S. have diagnosed peanut allergies: - 390,000 children aged 4-7 - 280,000 children aged 1-3 - **Response Rates**: In the 1-3 age group, the response rate was 67% for active treatment compared to 33.5% for placebo, with a 22.4% delta [24][25] Clinical Trial Insights - **VITESSE Trial**: The largest trial for peanut allergy with 654 patients, showing a placebo-adjusted efficacy of 32 points [13][14] - **Long-term Benefits**: Open-label extensions indicate improved efficacy and safety over time, with 68% of children in the 1-3 age group able to consume significant amounts of peanuts without anaphylaxis after three years of treatment [25][26] Competitive Landscape - **Comparison with IgE Blockade**: DBV Technologies focuses on desensitization, which is seen as disease-modifying, while IgE blockade is viewed as a temporary solution [5][7][58] - **Palforzia Comparison**: DBV believes Viaskin Peanut is superior due to its ease of use and lower risk of anaphylaxis compared to Palforzia, which requires frequent physician visits and has a higher rate of anaphylaxis during treatment [63][64] Commercial Strategy - **Target Audience**: Approximately 4,500 allergists and immunologists in the U.S. will be targeted for prescribing [43] - **Sales Force**: Estimated need for 50-70 sales representatives to reach the target audience effectively [46] - **Pricing Strategy**: While no final price has been set, Palforzia's pricing at around $1,000 per month is considered a reference point [47][48] Future Directions - **Expansion Plans**: After the approval of Viaskin Peanut, the company plans to pursue other allergies, with cow's milk allergy as the next target [82] - **Manufacturing Capacity**: Current manufacturing is sufficient for initial launch, but plans to triple capacity in the coming years are in place [83] Financial Position - **Funding**: As of Q3, the company has $320 million, which is deemed sufficient to support the launch in 2027 and necessary investments [88][91] Additional Insights - **Engagement with Families**: The company emphasizes the importance of communication with families and patient advocacy groups, as parents of children with food allergies are highly engaged [46] - **Safety Profile**: The Viaskin Peanut patch has shown no severe adverse events in clinical studies, which may lead to a cleaner label compared to other treatments [74][75] This summary encapsulates the critical aspects of DBV Technologies' conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the food allergy treatment landscape.

2025 Year-End Earnings Webinar February 12, 2026 8-K Date: February 12, 2026 Forward-Looking Statements Information in this communication, other than statements of historical facts, may constitute forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements about the benefits of the proposed transaction between NorthWestern and Black Hil ...

Aclaris Therapeutics Conference Call Summary Company Overview - **Company**: Aclaris Therapeutics (NasdaqGS: ACRS) - **Focus**: Clinical stage biopharmaceutical company specializing in large molecule and small molecule therapeutics [4][5] Key Developments and Programs Large Molecule Therapeutics - **TSLP Monoclonal Antibody**: Currently in a 90-patient study for moderate to severe atopic dermatitis (AD), with results expected in late 2026 [4] - **Bispecific Antibody**: Built off the TSLP monoclonal antibody with an IL-4R construct, showing highly positive pharmacokinetic/pharmacodynamic (PK/PD) data [4][5] - **Phase 1b Studies**: Ongoing studies for severe AD and moderate asthma, with readouts also expected in late 2026 [5] Small Molecule Therapeutics - **ITK Franchise**: Lead molecule 2138 is an ITK JAK3 inhibitor, ready for Phase IIb trials. The company is selecting a lead indication for this asset [5][6] - **Next Generation ITK**: Development of super selective ITK inhibitors, with IND enabling discussions ongoing [6] Clinical Data and Efficacy - **Bosakitug (TSLP-targeted monoclonal)**: Demonstrated a 94% EASI-75 response and an 88% IGA 0/1 in previous studies, indicating strong efficacy [9][10] - **Bispecific Antibody**: Achieved a 26-day half-life and demonstrated effective inhibition of TSLP and IL-4R, with a goal of maximizing response in AD and asthma [14][15][17] Safety and Tolerability - **Injection Site Reactions (ISRs)**: Most common adverse event observed, generally mild and resolving without intervention [20][21] - **Overall Safety Profile**: Data from chronic toxicity studies and Phase 2a trials indicate a clean safety profile for lead compounds [73] Competitive Landscape and Market Opportunities - **JAK Inhibitor Market**: Aclaris aims to differentiate its products by focusing on more selective ITK inhibitors, which may have fewer immunosuppressive effects compared to traditional JAK inhibitors [35][63] - **Potential Indications**: Considering various inflammatory disorders, including alopecia and lichen planus, as potential targets for 2138 [45][46] Future Catalysts - **Upcoming Trials**: Phase 1b studies for AD and asthma are expected to provide significant data on efficacy and safety [24][28] - **IND Filing**: Planned for the next generation ITK compound towards the end of the year, with expectations to catch up to competitors [75] Conclusion Aclaris Therapeutics is positioned to make significant advancements in the biopharmaceutical space with its innovative therapies targeting atopic dermatitis and asthma. The company is focused on maximizing efficacy while maintaining a favorable safety profile, with several key trials and developments on the horizon.