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Ascletis Announces Positive Topline Results from U.S. Phase I Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor
Prnewswire· 2025-12-15 09:00
Core Insights - Ascletis Pharma Inc. announced positive topline results from a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting IL-17, indicating favorable safety, tolerability, and pharmacokinetics [3][5][7] Group 1: Clinical Trial Results - The Phase I clinical trial was randomized, double-blind, and placebo-controlled, involving 46 healthy participants who received varying doses of ASC50 [3] - ASC50 demonstrated a dose-proportional pharmacokinetic profile from 10 mg to 600 mg, with an elimination half-life ranging from 43 to 104 hours depending on the dose [1][2][8] - All adverse events reported were mild and transient, with no serious adverse events or discontinuations noted during the study [8] Group 2: Target Engagement and Efficacy - Strong target engagement was observed with elevated plasma IL-17A levels persisting until day 7 for higher doses of ASC50 [1][8] - The drug showed higher absolute oral bioavailability and longer half-life compared to another IL-17 inhibitor currently in clinical development [8] Group 3: Future Development - Based on the positive results, ASC50 is advancing to the next phase of clinical development, focusing on multiple ascending doses in participants with mild to moderate plaque psoriasis [5] - ASC50 is positioned as a potential best-in-class oral small molecule IL-17 inhibitor, developed using Artificial Intelligence-assisted Structure-Based Drug Discovery technology [6][7]
Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment
Prnewswire· 2025-12-10 09:15
Core Insights - Ascletis Pharma Inc. has received acceptance for its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class oral fatty acid synthase inhibitor aimed at treating moderate-to-severe acne vulgaris, by the China National Medical Products Administration (NMPA) [2][3] - The Phase III clinical trial results demonstrated that denifanstat (ASC40) met all primary and secondary efficacy endpoints, showing significant improvement in acne vulgaris compared to placebo, with a favorable safety profile [4][5] Group 1 - The acceptance of the NDA is a significant milestone for Ascletis in its efforts to commercialize denifanstat (ASC40) [3] - Denifanstat (ASC40) has completed both Phase II and Phase III studies for the treatment of moderate-to-severe acne vulgaris [3][5] - The Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025, indicating the company's active engagement in scientific discourse [5] Group 2 - The Phase III study reported that all treatment-emergent adverse events (TEAEs) related to denifanstat (ASC40) were mild or moderate, with no severe adverse events observed [4] - Ascletis has licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China, highlighting strategic partnerships in drug development [5] - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced technologies in drug discovery [6]
Solid property and financial performance & dividend up for the 11th consecutive year
Globenewswire· 2025-11-26 16:40
Core Insights - The company reported solid property and financial performance with an increase in dividend for the 11th consecutive year [1][3] Financial Performance - EPRA occupancy rate stands at 97.2% [1] - Gross yield on the portfolio is 6.96% [1] - Average cost of debt is 2.15% [1] - Interest rates hedge ratio is 96.6% [1] - Gross dividend yield is 8.7% [1] Dividend Information - Proposed distribution of a gross dividend of €4.45 per share, up by 3.5% from €4.30 per share the previous year [3] Operational Results - Rental income reached €53.9 million, an increase of 1.0% compared to €53.3 million at 30/09/2024 [5] - EPRA earnings amounted to €36.7 million, up by 1.4% from €36.2 million at 30/09/2024 [5] - EPRA earnings per share is €5.56, compared to €5.49 at 30/09/2024 [5] - Net result is €35.6 million, an increase from €25.5 million at 30/09/2024 [5] Balance Sheet Information - Fair value of the portfolio is €746.5 million, down from €748.6 million at 30/09/2024 [5] - EPRA Debt ratio (EPRA LTV) is 40.7%, down from 42.1% at 30/09/2024 [5] - Net asset value (EPRA NTA) per share is €67.14, compared to €65.80 at 30/09/2024 [5]
Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development
Prnewswire· 2025-11-12 23:30
Core Insights - Ascletis Pharma Inc. has announced the co-formulation of ASC36, a once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist, for clinical development targeting obesity [5][6] Pharmacokinetics and Efficacy - The co-formulation of ASC36 and ASC35 demonstrated a comparable pharmacokinetic profile to the individual dosing of ASC36 and ASC35 in non-human primate studies, supporting once-monthly subcutaneous administration [7] - ASC36 monotherapy showed approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in diet-induced obese (DIO) rat studies, while ASC35 monotherapy exhibited approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in DIO mouse studies [2][8] - The co-formulation of ASC36 and ASC35 resulted in approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in DIO rat studies [3][9] Stability and Formulation - The co-formulation of ASC36 and ASC35 exhibited excellent chemical and physical stability, with no aggregation or precipitation at neutral pH, which is crucial for maintaining potency and reducing immunogenicity risks [6][3] Regulatory and Future Plans - The company plans to submit an Investigational New Drug Application (IND) to the U.S. FDA for the co-formulation of ASC36 and ASC35 in the second quarter of 2026 [4][5] - A conference call is scheduled for November 13, 2025, to discuss further developments [12] Technological Advancements - Ascletis utilized its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies to develop ASC36 and ASC35, enabling the design of multiple once-monthly subcutaneous ultra-long-acting peptides [6][11]
Ardmore Shipping(ASC) - 2025 Q3 - Earnings Call Transcript
2025-11-05 16:02
Financial Data and Key Metrics Changes - The company reported adjusted earnings of $12.6 million or $0.31 per share for the third quarter of 2025, with earnings increasing throughout the quarter and into the fourth quarter due to record volumes of refined products [4][11] - EBITDA for the third quarter was $27.6 million, with a cash break-even level reduced to $11,700 per day, and an even lower operating break-even of $10,800 per day [11][12] Business Line Data and Key Metrics Changes - The company's MRs earned $24,700 per day in the third quarter and $24,900 so far in the fourth quarter, with 40% booked [5] - Chemical tankers earned $22,600 per day in the third quarter and $22,200 so far in the fourth quarter, with 35% booked [5] Market Data and Key Metrics Changes - Export volumes in refined products reached record levels during the quarter, driving robust product tanker demand [8] - 50% of the LR2 fleet is now trading in the crude market, up 23% over the past year, indicating tight supply-demand balances [8] - 16% of the global tanker fleet is sanctioned, significantly reducing the pool of compliant vessels [8] Company Strategy and Development Direction - The company is focused on balancing capital returns to shareholders while growing the business and reinvesting in the fleet, maintaining low debt levels [6][7] - The company has fully redeemed $30 million of preferred shares, further reducing cash break-even levels and enhancing the quality of its trading book through long-term charter contracts [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term demand drivers for product tankers, noting significant geopolitical factors creating volatility and increased trading activity [21][23] - The company highlighted the ongoing evolution of trade flows and long-term demand, particularly in regions like California where refined product imports are up 50% year-on-year [10] Other Important Information - The company is investing in digitalization projects and fuel efficiency upgrades, with capital expenditures for 2025 projected at $37 million [12] - The on-hire availability of the fleet was strong at 99% in the third quarter, reflecting effective operations [13] Q&A Session Summary Question: Insights on MR spot rates and winter expectations - Management acknowledged the correlation between MR and crude tanker rates, expressing confidence in the significant ramp-up in earnings and long-term demand drivers [20][21] Question: Thoughts on chartering strategy and appetite for similar deals - Management explained the decision to lock in a long-term charter with an oil major as a way to secure strong returns while maintaining a balanced portfolio approach [25][26] Question: Market outlook and capital deployment strategy - Management indicated that future capital deployment will be guided by market conditions, with a focus on value-enhancing transactions and maintaining a strong governance framework [38][40]
Ardmore Shipping(ASC) - 2025 Q3 - Earnings Call Transcript
2025-11-05 16:02
Financial Data and Key Metrics Changes - The company reported adjusted earnings of $12.6 million or $0.31 per share for the third quarter of 2025, with earnings increasing throughout the quarter and into the fourth, driven by record volumes of refined product on the water [4][11] - EBITDA for the third quarter was $27.6 million, with a cash break-even level reduced to $11,700 per day, and an even lower operating break-even of $10,800 per day [11][12] Business Line Data and Key Metrics Changes - The company's MRs earned $24,700 per day in the third quarter and $24,900 so far in the fourth quarter, with 40% booked [5] - Chemical tankers earned $22,600 per day in the third quarter and $22,200 so far in the fourth quarter, with 35% booked [5] Market Data and Key Metrics Changes - Export volumes in refined products reached record levels during the quarter, fueling robust product tanker demand, while high crude fleet utilization is tightening supply across the tanker industry [8] - 16% of the global tanker fleet is now sanctioned, significantly reducing the pool of compliant vessels and limiting available supply [8][9] Company Strategy and Development Direction - The company is focused on balancing capital returns to shareholders with business growth and fleet reinvestment while maintaining low debt levels [6][7] - The company has fully redeemed $30 million of preferred shares, further reducing cash break-even levels and enhancing the quality of its trading book through long-term charter contracts [5][11] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term demand drivers for product tankers, noting significant geopolitical factors creating volatility and increased trading activity [18][19] - The company highlighted the evolving trade flows and long-term demand, with a shift in the global refinery base and increased imports in regions like California [10][11] Other Important Information - The company is investing in AI and digitalization projects for voyage optimization and has achieved full fuel EU compliance across the fleet in 2025 [12][13] - The company has a strong on-hire availability of 99% in the third quarter, reflecting effective operations [13] Q&A Session Summary Question: Insights on MR spot rates and winter expectations - Management acknowledged the correlation between MR and crude tanker rates, expressing confidence in the significant ramp-up in earnings and long-term demand drivers for product tankers [16][17] Question: Thoughts on chartering strategy and appetite for similar deals - Management explained the decision to lock in a long-term charter with a high-quality counterparty as part of a balanced portfolio strategy, indicating ongoing evaluation of opportunities [20][21] Question: Market outlook and capital deployment strategy - Management emphasized that future steps will be guided by market conditions, with a focus on value-enhancing transactions and maintaining a disciplined approach to capital allocation [32][34]
Ardmore Shipping(ASC) - 2025 Q3 - Earnings Call Transcript
2025-11-05 16:00
Financial Data and Key Metrics Changes - The company reported adjusted earnings of $12.6 million or $0.31 per share for Q3 2025, with earnings increasing throughout the quarter and into Q4, driven by record volumes of refined products [5][12] - EBITDA for the third quarter was $27.6 million, with a cash break-even level reduced to $11,700 per day, and an operating break-even of $10,800 per day [12][15] Business Line Data and Key Metrics Changes - The company's MRs earned $24,700 per day in Q3 and $24,900 so far in Q4, with 40% booked [6] - Chemical tankers earned $22,600 per day in Q3 and $22,200 so far in Q4, with 35% booked [6] Market Data and Key Metrics Changes - Export volumes in refined products reached record levels, fueling robust product tanker demand, while high crude fleet utilization is tightening supply across the tanker industry [8][9] - 50% of the LR2 fleet is now trading in the crude market, up 23% over the past year [9] Company Strategy and Development Direction - The company is focused on balancing capital returns to shareholders with business growth and fleet reinvestment while maintaining low debt levels [7][15] - The company has fully redeemed $30 million of preferred shares, enhancing its capital structure and reducing cash break-even levels [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the market outlook, citing significant near-term disruptions and tight supply-demand balances [8][23] - Geopolitical factors are creating inefficiencies that favorably impact the market, with 16% of the global tanker fleet now sanctioned [9][10] Other Important Information - The company is investing in digitalization projects and biofuel bunkers to support trading strategies in the EU, achieving full fuel compliance across the fleet in 2025 [13][14] - The company has a strong on-hire availability of 99% in Q3, reflecting effective operations [14] Q&A Session Summary Question: Insights on MR spot rates and winter expectations - Management acknowledged the correlation between MR and crude tanker rates, expressing confidence in the significant ramp-up in earnings and long-term demand drivers [20][22] Question: Market dynamics and product tanker performance - Management noted that while product tankers have improved, they have not surged like crude tankers, attributing this to the need for cargoes to deliver into the refining system [29][31] Question: Future capital deployment strategy - Management indicated that future steps will be guided by market conditions, with a focus on value-enhancing transactions and maintaining a balanced approach to capital allocation [35][37]
Ardmore Shipping (ASC) Q3 2025 Earnings Transcript
Yahoo Finance· 2025-11-05 15:48
Core Insights - The company is focused on disciplined capital allocation, balancing shareholder returns with business growth and fleet reinvestment while maintaining low debt levels [1][2][4] - The company has declared its twelfth consecutive dividend and fully redeemed $30 million of preferred shares, which has reduced cash breakeven levels [2][10] - The market for product tankers is experiencing strong demand due to record export volumes and refined products in transit, alongside geopolitical factors affecting supply [5][6][20] Financial Performance - The company reported adjusted earnings of $12.6 million or $0.31 per share for the third quarter, with earnings increasing throughout the quarter [4][10] - The average Time Charter Equivalent (TCE) rates for MRs were $24,700 per day in Q3 and $24,900 so far in Q4, significantly above cash breakeven levels [3][10] - EBITDAR for the third quarter was reported at $27.6 million, indicating strong operational performance [10] Market Dynamics - The product tanker market is characterized by tight supply-demand balances, with 50% of the LR2 fleet now trading in the crude market, a 23% increase over the past year [5][6] - Geopolitical factors have led to 16% of the global tanker fleet being sanctioned, reducing the pool of compliant vessels and limiting available supply [5][6] - The aging fleet and a shrinking order book, with only 13% of the fleet represented in the order book, are expected to create favorable supply dynamics [7][8] Strategic Initiatives - The company is enhancing its trading book through long-term charter contracts, including a recent two-year charter at $21,250 per day with an oil major [2][23] - Capital expenditures for 2025 are projected at $37 million, with a focus on efficiency upgrades and tank coating projects [11][32] - The company is investing in digitalization and AI projects to optimize voyage performance and achieve full fuel compliance by 2025 [12][32] Future Outlook - The company anticipates continued strength in earnings supported by favorable market conditions and strong operational performance [13][20] - The evolving trade flows and long-term demand for product tankers are expected to drive ton-mile demand, particularly as refinery capacities shift towards Asia and the Middle East [7][8][20] - The company remains flexible in capital deployment, considering both shareholder returns and reinvestment opportunities based on market conditions [30][32]
Ardmore Shipping(ASC) - 2025 Q3 - Earnings Call Presentation
2025-11-05 15:00
Financial Performance - Ardmore Shipping reported adjusted earnings of $12.6 million, or $0.31 per share[9] - The company's cash breakeven is $11,700, and the operating cash breakeven is $10,800[9] - Adjusted EBITDAR was $27.6 million in 3Q 2025[42] - For 4Q 2025, the MR Combined spot TCE is expected to be $24,900 (40% fixed), and the Chemical spot TCE is expected to be $22,200 (35% fixed)[8,66] Market Dynamics - Refined product export volumes increased by 4% QoQ, reaching record levels[18] - Sanctioned fleet represents 16% of the global tanker fleet[24] - 2025 ordering activity is down 80% YoY[25] Fleet and Operations - The company fully redeemed $30 million preferred shares[9] - The company time chartered-out a 2014-built MR for two years at $21,250 per day[9] - The company estimates 2025 fleet capex of $37 million, including elective capex of $16 million[46] - The company achieved 99% on-hire availability in 3Q 2025[46]
Ardmore Shipping Corporation Announces Financial Results For The Three and Nine Months Ended September 30, 2025
Prnewswire· 2025-11-05 13:00
Core Insights - Ardmore Shipping Corporation reported increased earnings driven by record volumes of refined products and strategic acquisitions of modern MR tankers [3][4] - The company declared its twelfth consecutive dividend while redeeming all outstanding preferred shares, reflecting a strong capital allocation policy [3][4][9] - Freight markets remain robust due to long-term sectoral trends, healthy refining margins, and geopolitical factors impacting supply and demand [3][15][16] Financial Performance - For Q3 2025, Ardmore reported adjusted earnings of $12.6 million, down from $23.3 million in Q3 2024, with earnings per share decreasing from $0.55 to $0.30 [4][18] - For the nine months ended September 30, 2025, adjusted earnings were $27.2 million compared to $109.3 million for the same period in 2024, with earnings per share dropping from $2.62 to $0.67 [4][19] - Revenue for Q3 2025 was $81.2 million, a decrease of $14.9 million from $96.1 million in Q3 2024, attributed to fewer spot revenue days and lower spot rates [20] Fleet Operations - As of September 30, 2025, the company operated 27 vessels, including 21 MR tankers and 6 chemical tankers [5] - The average spot TCE rate for MR tankers was $24,697 per day in Q3 2025, with a projected rate of $24,900 for Q4 2025 [6] - The company took delivery of three modern MR tankers during Q3 2025, enhancing fleet quality and reducing average fleet age [10] Expenses and Costs - Voyage expenses decreased to $28.5 million in Q3 2025 from $34.6 million in Q3 2024, primarily due to lower bunker costs [23] - Vessel operating expenses increased to $16.4 million in Q3 2025, reflecting the addition of three vessels to the fleet [25] - Total charter hire expense was $4.6 million for Q3 2025, down from $5.9 million in Q3 2024, due to the redelivery of chartered-in vessels [26] Liquidity and Financing - As of September 30, 2025, Ardmore had $296.0 million in liquidity, including $47.1 million in cash and cash equivalents [34] - The company closed a $350 million revolving credit facility in July 2025, secured by 20 owned vessels, maturing in 2031 [12] Geopolitical Impact - Ongoing geopolitical conflicts, including the Russia-Ukraine conflict and tensions in the Middle East, have disrupted energy supply chains and contributed to increased spot tanker rates [15][16][17]