Seralutinib Partnership with Chiesi - Chiesi will provide a $160 million immediate development reimbursement to Gossamer[13] - Gossamer and Chiesi will split US profits 50/50, with mid-to-high teens royalties to Gossamer ex-US[13] - Regulatory milestones could reach up to $146 million, and sales milestones up to $180 million[13] - R&D costs will be split 50/50 worldwide, with Gossamer leading global development and US commercialization of PAH & PH-ILD[13] - Gossamer has a pro forma cash position of approximately $396 million[20, 38] Seralutinib in PAH - Seralutinib is in an ongoing registrational Phase 3 trial for PAH, with topline results expected in Q4 2025[13, 24, 26] - The PROSERA Phase 3 study is a double-blind, placebo-controlled trial with 175 patients per arm[26] - The US has approximately 30,000 to 50,000 PAH patients, with a 5-year survival rate of 57%[13, 22, 23, 35] Seralutinib in PH-ILD - The US has approximately 60,000 to 100,000 PH-ILD patients[13, 29, 35] - The median 5-year survival for PH-ILD patients is 23%[13, 35] - A Phase 3 study in PH-ILD is expected to begin in mid-2025[13, 20] - Only one therapy is approved for PH-ILD in the US[29, 30, 35]

Becker Muscular Dystrophy (BMD) - Sevasemten shows positive observations in Becker patients with continued dosing[12] - A positive Type C FDA meeting offers a clear path to potential approval for Sevasemten[12] - The GRAND CANYON trial is on track for topline data in Q4 2026[12], with >98% power to deliver a statistically significant difference in NSAA vs placebo[20] - In the CANYON study, the NSAA score between the Sevasemten group and the placebo group showed a difference of +1.12 at month 12[27] - In the MESA open-label study, 99% of eligible participants are currently enrolled[30] - Natural history modeling reveals that 92% of CANYON participants improved vs their predicted scores[39], and 89% of ARCH participants achieved higher NSAA scores vs predicted[42] Duchenne Muscular Dystrophy (DMD) - In the LYNX & FOX trials, Sevasemten treatment reduced the functional decline in Duchenne patients[15] - A path to Phase 3 is open with the selection of 10 mg as the target dose[16] - In Duchenne patients, a -82% change in TNNI2 was observed in the 30mg cohort at Month 3[72] - In the FOX study, participants are an average of 11 years old and 4 years out from receiving gene therapy[99] Financial Status - Edgewise has approximately $624 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a cash runway through 2028[112][113]

Financial Performance - American Water's adjusted earnings per share (EPS) from continuing operations increased from $2.64 in 2015 to $2.84 in 2016[29] - The company affirms its 2017 guidance range for EPS to be $2.98 - $3.08[79] - The company anticipates a 7-10% EPS Compound Annual Growth Rate (CAGR) through 2021, anchored off 2015 EPS[34] - The company's common dividends declared showed a CAGR of 10% from 2014 to 2017[35] - American Water's capital investment reached a record level of $1.3 billion in 2016 for regulated infrastructure[24] - Cash flow from operations increased by 8.2% from 2015 to 2016[77] Regulated Business - The company's regulated business remains the foundation of its long-term growth strategy[23] - The Illinois Commerce Commission approved a $35.2 million rate increase for American Water, authorizing a 9.79% Return on Equity (ROE)[41] - The company closed acquisitions serving approximately 42,000 customers and had pending acquisitions for approximately 40,000 customers in 2016[24] - The company's O&M efficiency ratio improved to 34.9% in 2016 and is targeting 32.5% by 2021[24, 50]

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, has appointed Renée Aguiar-Lucander to its Board of Directors, a decision approved by shareholders at the recent Annual General Meeting [1][2] - The company is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently in the final stages of clinical development for its drug lanifibranor [1][3] Company Overview - Inventiva specializes in the research and development of oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Leadership Background - Renée Aguiar-Lucander, the newly appointed board member, has a strong background in the biopharmaceutical industry, having served as CEO of Hansa Biopharma and Calliditas Therapeutics, where she led the latter to a $1.1 billion acquisition by Asahi Kasei in 2024 [2] - Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy and successfully launched the product in the U.S. [2] Strategic Importance - The appointment of Aguiar-Lucander is seen as pivotal for Inventiva as it prepares for the potential approval and launch of lanifibranor [2] - The NATiV3 Phase 3 trial is fully enrolled, indicating progress towards bringing lanifibranor to patients with MASH [2]

Financial Performance & Outlook - PTC achieved total revenue of $807 million in 2024[14] - PTC has a strong cash position of over $2 billion, enabling future revenue growth and R&D innovation[15] - PTC aims to reach cash flow break-even without additional capital[16] - PTC's vision includes a path to $2 billion in topline revenue[53] Key Product Programs & Milestones - Four U S regulatory approval applications were submitted in 2024[11] - AADC Gene Therapy BLA was approved[12] - Sephience (sepiapterin) in PKU has a potential revenue opportunity greater than $1 billion[28] - Vatiquinone for Friedreich's Ataxia (FA) has an NDA filing accepted with Priority Review, with an approval decision expected August 19, 2025[32] - PTC518 for Huntington's Disease (HD) has a development and commercialization collaboration with Novartis, including $1 billion upfront payment and up to $19 billion in milestones[45] Research & Development - PTC has innovative research platforms, including a validated splicing platform[48] - PTC has inflammation & ferroptosis programs targeting CNS and non-CNS disorders[50]

Core Insights - Chemomab Therapeutics has achieved significant milestones in the development of nebokitug for the treatment of primary sclerosing cholangitis (PSC), including a clear regulatory pathway with the FDA for potential full approval and positive 48-week data from the Phase 2 SPRING trial [1][2][10] Company Developments - The company reported that nebokitug treatment in PSC patients with moderate/advanced disease resulted in continued improvements across key biomarkers of liver injury, inflammation, and fibrosis [1][2] - Chemomab has aligned with the FDA on a streamlined regulatory approval program for nebokitug, which will utilize a single pivotal Phase 3 trial based on clinical events associated with disease progression, eliminating the need for liver biopsies [2][10] - The positive results from the SPRING trial indicate that nebokitug-treated patients showed a significantly lower number of clinical events compared to historical controls, particularly in the 20 mg/kg dose group [2][4] Financial Highlights - As of March 31, 2025, Chemomab's cash position was $10.6 million, down from $14.3 million at the end of 2024, with a cash runway expected to last until the second quarter of 2026 [5][8] - The company reported a net loss of $3.3 million for the first quarter of 2025, compared to a net loss of $3.9 million in the same period of 2024 [8][14] Research and Development - R&D expenses for the first quarter of 2025 were $2.5 million, a decrease from $3.1 million in the first quarter of 2024, primarily due to the winding down of activities related to the Phase 2 SPRING trial [8][13] - The company is actively pursuing multiple partnering options to advance the nebokitug program and is in discussions with potential strategic partners [1][2] Clinical Trial Updates - Data from the Phase 2 SPRING trial was presented at major conferences, including Digestive Disease Week 2025 and EASL 2025, highlighting the drug's potential in treating PSC [3][4] - The Open Label Extension study confirmed that nebokitug was safe and well-tolerated over 12 months, with significant improvements in liver biomarkers and stabilization of cholestasis-related markers [6][10]

Financial Data and Key Metrics Changes - Earnings per share for Q1 2025 were $1.05, an increase of nearly 11% compared to $0.95 in Q1 2024 [7] - Consolidated reported earnings were $1.5 per share, up $0.10 per share versus the same period in 2024 [13] - Revenues increased by $0.44 per share, primarily due to authorized rate increases and organic customer growth [13] Business Line Data and Key Metrics Changes - Operating costs increased by $0.15 per share, driven by employee-related costs and acquisitions [14] - Depreciation increased by $0.11 per share and financing costs increased by $0.10 per share, both as expected to support investment growth [14] Market Data and Key Metrics Changes - The company achieved an annualized revenue increase of $63 million in Missouri, with new rates expected to take effect on May 31, 2025 [15] - In Virginia, an annualized increase of $15 million in water and wastewater revenues was approved [16] Company Strategy and Development Direction - The company affirmed long-term targets for earnings and dividend growth at 7% to 9%, driven by 8% to 9% rate base growth [10] - The Board approved an increase in the quarterly cash dividend from $0.765 to $0.825, an 8.2% increase [11] - The company is focused on infrastructure investments and acquisitions to support growth, with a capital investment goal of approximately $3.3 billion in 2025 [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 EPS guidance, representing 8% annual growth [20] - The company noted that recent tariff-related announcements are not expected to materially impact 2025 plans or financial results [21] - The management highlighted the need for significant investments in U.S. water infrastructure, estimating a total need of $625 billion over the next twenty years [30] Other Important Information - The company is well-positioned for growth through acquisitions, with about 37,000 customer connections under agreement [28] - The American Society of Civil Engineers rated the nation's drinking water systems a C- and wastewater systems a D+, indicating a dire need for infrastructure investment [30] Q&A Session Summary Question: Thoughts on pulling forward 2026 equity issuance - The company has no plans to pull forward equity issuance and will issue equity when needed [39] Question: Acquisition outlook under potential recession - The company expects a continuous flow of acquisition opportunities, potentially driven by recession or reduced federal funding [40] Question: Update on California desalination project - The company expects to break ground on the desalination project this year, which is separate from the rate case [52] Question: Legislative progress and opportunities - The company has not quantified the opportunities from legislative changes but noted they will help earned returns [61]