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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]
Ascletis Presents Full Analysis of Phase Ib Study of ASC30 Oral Tablet, Phase Ib Study of ASC30 Injection, and Preclinical Study of Combination of ASC31 and ASC47 at ObesityWeek® 2025
Prnewswire· 2025-11-05 00:10
Core Insights - Ascletis Pharma Inc. presented promising data from Phase Ib studies of its obesity treatment candidates, ASC30 and the combination of ASC31 and ASC47, at ObesityWeek 2025, highlighting their efficacy and safety profiles [4][15]. Group 1: ASC30 Oral Tablet - The Phase Ib study of ASC30 oral tablet demonstrated a placebo-adjusted mean body weight reduction of up to 6.5% after 28 days of treatment, with the highest dose (60 mg) showing a maximum reduction of 9.3% [1][8]. - The study reported mild-to-moderate gastrointestinal adverse events (AEs), with no serious adverse events (SAEs) observed across all cohorts [7][8]. - The safety profile of ASC30 was consistent with or better than that of the GLP-1R agonist class, indicating it is safe and well tolerated [8]. Group 2: ASC30 Subcutaneous Injection - The Phase Ib study of ASC30 subcutaneous injection revealed an observed half-life of 46 days for the treatment formulation and 75 days for the maintenance formulation, supporting once-monthly and once-quarterly dosing [2][10]. - Similar to the oral tablet, the subcutaneous formulations were well tolerated, with only mild-to-moderate treatment-emergent adverse events reported [11][9]. - No serious adverse events or significant safety signals were detected, reinforcing the safety of ASC30 formulations [9][10]. Group 3: Combination of ASC31 and ASC47 - The combination of ASC31 and ASC47 significantly outperformed both tirzepatide and ASC31 monotherapy in weight loss, achieving a 44.8% reduction in weight compared to 19.1% for ASC31 alone, representing a 134% greater reduction [12][13]. - The combination also demonstrated superior results in body fat loss and muscle preservation, restoring the body composition of obese mice to that of healthy non-obese mice [13]. - ASC31 is a dual GLP-1R and GIPR peptide agonist, while ASC47 is designed for targeted delivery to adipose tissue, showcasing Ascletis' innovative approach in obesity treatment [12][13].