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Eli Lilly (LLY) Earnings Call Presentation
2025-07-11 08:32
Company Strategy & Market Opportunity - Lilly aims to provide freedom from diabetes, eliminate serious health issues caused by obesity, and reduce cardiovascular deaths[10] - The company estimates a significant addressable market of over 170 million patients by 2030 for obesity and related conditions[13] - Outside of the US, the addressable market is expected to be approximately 1 billion patients[15] Orforglipron Development Program - Orforglipron, a GLP-1 small molecule, has a broad development plan including studies for Type 2 Diabetes, obesity, hypertension, and obstructive sleep apnea[20] - In the ACHIEVE-1 trial, all three doses of orforglipron achieved superiority versus placebo in reducing HbA1c levels in patients with Type 2 Diabetes[27] - ACHIEVE-1 trial data showed significant reductions in HbA1c observed as early as 4 weeks, with approximately 3/4 of patients achieving an ADA HbA1c target of less than 7%, and 2/3 reaching HbA1c ≤6.5%[27] - ACHIEVE-1 trial also demonstrated dose-dependent reduction in body weight, with approximately 2/3 of patients achieving ≥5% weight reduction and approximately 1/3 achieving ≥10% weight reduction[30] - Topline results for ATTAIN-1, an orforglipron trial in obesity, are expected in Q3 2025[39] Retatrutide Development Program - Retatrutide is undergoing global development with the TRIUMPH program for obesity and related complications, and the TRANSCEND program for Type 2 Diabetes[41] - Topline results for TRIUMPH-4, a retatrutide trial in knee osteoarthritis pain and overweight or obesity, are expected in Q4 2025[48] Tirzepatide & Early Phase Pipeline - The SURPASS-CVOT trial is designed to evaluate tirzepatide against dulaglutide in patients with established cardiovascular disease[51] - Eloralintide, a selective amylin receptor agonist, showed weight loss up to 11.3% in Phase 1 trials and is well-tolerated with less than 10% incidence of GI side effects[60]
Esperion Therapeutics (ESPR) 2022 Earnings Call Presentation
2025-07-03 08:17
WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? FORWARD-LOOKNG STATEMENTS & DISCLOSURES This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, restructuring and current and planned operational expenses, future operations, commercial products, clinical development including the timing, designs and plans for the CLEAR Outcomes study and its resu ...
Esperion Appoints Craig Thompson to Board of Directors
Globenewswire· 2025-07-01 12:06
Brings More Than Twenty Years of Biopharmaceutical Leadership ExperienceANN ARBOR, Mich., July 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it has appointed Craig Thompson, Chief Executive Officer of Cerevance, to its Board of Directors. Mr. Thompson will serve as an independent director. With Mr. Thompson’s appointment, Esperion’s Board of Directors now comprises eight members. “We are thrilled to welcome Craig to our Board of Directors. With more than two decades of biopharmaceutic ...
Veru to Participate in the Virtual BTIG Obesity Health Forum
Globenewswire· 2025-06-11 12:30
MIAMI, FL, June 11, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the company will be participating in one-on-one meetings and a fire side chat presentation with investors at the virtual BTIG Obesity Health Forum on June 18, 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative m ...
Ventyx Biosciences (VTYX) 2025 Conference Transcript
2025-06-05 17:50
Ventyx Biosciences (VTYX) 2025 Conference June 05, 2025 12:50 PM ET Speaker0 Don't worry, we would not miss this. Speaker1 Never a doubt, Mike. Speaker0 Good afternoon. I'm Michael Yee, a biotechnology analyst here at Jefferies. And very happy to moderate our next discussion with Ventix Biosciences. We have members of the of the team up here. We have Raju Mohan, CEO, and Matt Moore. Matt Moore. Fantastic. Maybe it would be a great opportunity, Raju, for you to just make some, broad opening comments. Ventix ...
Scholar Rock(SRRK) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:17
Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...
Veru Participates in a Virtual Investor KOL Connect Segment
Globenewswire· 2025-05-08 13:25
-- Moderated discussion with preeminent obesity expert, Louis J. Aronne, MD, FACP and Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru -- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the release of a Virtual Investor KOL segment featuring Louis J. Aronne, MD, FACP. As part of the segment, Mitch ...
Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress
Globenewswire· 2025-05-08 10:30
--Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 -- --Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 -- --With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program -- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical ...
Veru to Report Fiscal 2025 Second Quarter Financial Results on May 8
Globenewswire· 2025-05-01 12:30
Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] 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 [3] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]
MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential
Prnewswire· 2025-04-22 12:31
A Dose-Dependent Response in Body Weight Reduction Was Observed Between 8 mg and 32 mg DosesChange in BMI and Body Weight Adjusted for Height In the Treatment Groups, Showed a Significant Difference Compared to Placebo, Indicating Potentially Greater Efficacy with Increasing Dosage and Longer Duration of UseNo Drug-Induced Cardiovascular Effects Were Observed In Heart Rate or QTcF Measurements of Subjects Receiving up to 32 mg of DA-1726 at 4-WeeksAdditional Cohorts Being Added to Determine Maximum Tolerate ...