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MetaVia Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-08-07 12:31
Core Insights - MetaVia Inc. has initiated the first patient dosing in the 8-week 48 mg multiple ascending dose (MAD) cohort of its Phase 1 clinical trial for DA-1726, targeting obesity, with top-line data expected in Q4 2025 [1][2] - The company has signed a collaboration with Syntekabio to explore additional indications for DA-1241 beyond Metabolic Dysfunction-Associated Steatohepatitis (MASH) [1][5] - As of the end of Q2 2025, MetaVia reported $17.6 million in cash, which is anticipated to fund operations into 2026 [1][6] Clinical Development - DA-1726 is a dual agonist targeting GLP1R and GCGR, showing promising results in previous cohorts with an average weight loss of 4.3% and a maximum of 6.3% at the 32 mg dose [2][4] - The 48 mg cohort aims to evaluate longer-term efficacy and safety, building on the favorable safety profile observed in earlier trials [2][3] - DA-1241 has shown potential in reducing liver fat and inflammation when combined with an FGF21 analogue, with ongoing efforts to schedule an end-of-Phase 2 meeting with the FDA [2][5] Financial Performance - R&D expenses for Q2 2025 were approximately $2.3 million, a significant decrease from $8.1 million in Q2 2024, primarily due to lower direct expenses related to both DA-1241 and DA-1726 [4][6] - The net loss for Q2 2025 was $4.0 million, or $0.26 per share, compared to a net loss of $10.1 million, or $1.85 per share, in Q2 2024 [6][12] - Total operating expenses for Q2 2025 were approximately $4.3 million, down from $10.1 million in the same period last year, reflecting reduced R&D spending [6][12] Strategic Collaborations - The collaboration with Syntekabio aims to leverage AI for identifying new indications for DA-1241, enhancing its therapeutic profile [2][5] - MetaVia's partnership with Dong-A ST has facilitated funding and development efforts, with a recent private placement raising $10 million [5][6] Company Overview - MetaVia Inc. focuses on developing innovative therapies for cardiometabolic diseases, with DA-1726 and DA-1241 as its lead candidates [7]
Veru to Participate in the Virtual BTIG Obesity Health Forum
Globenewswire· 2025-06-11 12:30
Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [2] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [2] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [2] - Positive topline and safety results were announced from the Phase 2b QUALITY clinical study, which involved 168 older patients (≥60 years) receiving semaglutide for chronic weight management [3] - The Phase 2b extension study will evaluate whether enobosarm can prevent fat regain after stopping GLP-1 RA treatment, with topline results expected in Q2 2025 [3] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [4][5] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [4][5] - The company plans to submit a new IND for sabizabulin's proposed indication by the first half of 2026 [6] Market Opportunity - The decision to explore sabizabulin for atherosclerotic cardiovascular disease is based on the large global market opportunity and the high probability of success due to its mechanism of action being similar to colchicine [5] - The company aims to assess the progression of coronary atherosclerosis using coronary CT angiography imaging as a primary endpoint in a small Phase 2 proof of concept study [5]
Scholar Rock(SRRK) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:17
Financial Data and Key Metrics Changes - Scholar Rock reported a strong start to 2025, with significant progress in bringing up epitigromab for SMA patients globally [6][9] - The company ended the quarter with $364.4 million in cash, and has an additional $100 million available under its debt facility to support the upcoming launch [25][26] Business Line Data and Key Metrics Changes - The phase three SAPPHIRE trial for epitigromab showed a statistically significant improvement in motor function, indicating its potential to reverse SMA progression [7][13] - The company is preparing for a U.S. commercial launch of epitigromab anticipated in Q3 2025, with plans to expand into Europe, Asia Pacific, and Latin America [9][20] Market Data and Key Metrics Changes - Approximately 10,000 SMA patients in the U.S. and around 35,000 globally have received SMN-targeted therapies, highlighting the market potential for epitigromab [21][22] - Market research indicates that 90% of SMA patients are seeking new treatment options that improve muscle strength, emphasizing the demand for epitigromab [20] Company Strategy and Development Direction - Scholar Rock aims to establish itself as a fully integrated global biopharmaceutical company, focusing on the launch of epitigromab and expanding its pipeline into other neuromuscular disorders [9][28] - The company is also exploring the EMBRAZE study to understand its role in treating obesity, indicating a diversification of its research focus [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming U.S. launch and the potential for sustainable growth driven by epitigromab and its pipeline [9][28] - The management team is committed to ensuring that no patient with SMA is left behind, reflecting a strong patient-centric approach [29] Other Important Information - The BLA for epitigromab was granted priority review by the FDA, with a PDUFA date set for September 22, 2025 [8][15] - The company is actively engaging with U.S. payers and preparing for reimbursement discussions in Europe, indicating proactive market access strategies [30][35] Q&A Session Summary Question: How receptive are U.S. payers to coverage of combination therapy for SMA patients? - Management indicated that early discussions with U.S. payers have been positive, with a focus on the need for better therapeutic options for SMA patients [32][34] Question: Can you comment on interactions with the FDA regarding the upadacumab review? - Management reported that interactions with the FDA have been routine and constructive, with no issues anticipated for the September 22 PDUFA date [38][39] Question: What are the expectations for the EMBRAZE study data in June? - Management confirmed that the primary focus will be on the 24-week data, with additional follow-up information provided as necessary [42][43] Question: How are you evaluating the potential to secure a commercial partner for Europe? - Management stated that they do not prioritize finding a partner outside the U.S., as they feel well-equipped to serve patients directly [88][89] Question: What are the launch dynamics and early demand expectations for epitigromab? - Management expressed optimism about the launch, citing the 100% newborn screening for SMA in the U.S. and the concentration of patients in centers of excellence [69][70]
Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress
Globenewswire· 2025-05-08 10:30
Core Insights - Veru Inc. announced positive topline efficacy data from the Phase 2b QUALITY study, which demonstrated that enobosarm in combination with GLP-1 receptor agonists can lead to selective fat loss while preserving lean mass [3][4][8] - The company plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, expected to provide regulatory clarity [2][11] - Financial results for the second quarter of fiscal 2025 showed a decrease in net loss compared to the previous year, indicating improved financial performance [27][34] Clinical Development - The Phase 2b QUALITY study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide [4] - The enobosarm 3mg + semaglutide combination resulted in a >99% mean relative reduction in lean mass loss, outperforming the 6mg dose [4] - The ongoing Phase 2b extension maintenance study aims to evaluate the effects of stopping GLP-1 receptor agonist treatment while continuing enobosarm [10] Safety and Efficacy - Unblinded safety data from the Phase 2b QUALITY study is expected to be released soon, with no significant safety concerns reported so far [9] - The treatment with enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [5] - Enobosarm treatment preserved lean mass, leading to a shift in body composition towards greater fat loss [5][8] Financial Performance - For the second quarter of fiscal 2025, research and development expenses increased to $3.9 million from $3.0 million, while selling, general, and administrative expenses decreased to $5.2 million from $5.9 million [27] - The net loss from continuing operations decreased to $7.9 million, or $0.05 per share, compared to $8.7 million, or $0.06 per share in the previous year [27][34] - Cash and cash equivalents were reported at $20.0 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [24] Future Plans - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [14] - A Phase 3 clinical program is planned, focusing on older patients with obesity or overweight, assessing the effect of enobosarm on physical function and body composition [12][21] - Veru is exploring the clinical development of sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [15][19]