Product & Technology - Signos leverages AI and continuous glucose monitoring (CGM) via a wearable biosensor to provide real-time metabolic insights for weight management [2][3] - The device, featuring a micro-needle, is worn for 15 days and provides data accessible via a phone app [3][4] - Signos aims to predict weight-related outcomes by providing personalized recommendations (e.g, suggesting a walk after a meal) based on glucose levels [5] - Signos integrates with other wearable devices like Apple Watch, complementing their data with AI-driven predictions [13][14] Market & Competition - Signos positions itself as a complementary solution to GLP-1 drugs, targeting a broader audience beyond those with obesity, focusing on weight loss and maintenance [7] - The company aims to establish metabolism as the "fifth vital sign," promoting continuous monitoring outside of clinical settings [8] - The FDA clearance covers the device's accuracy in measuring glucose levels for weight management, including weight loss and maintenance [9] Business Model & Financials - The service costs $129 per month and is FSA/HSA eligible [6] - Signos is actively pursuing partnerships with insurers for reimbursement coverage [6] Clinical Benefits - Stabilizing glucose levels can lead to improved sleep quality, as demonstrated by a user experience of tripled deep sleep duration [11][12]

Health & Wellness Trends - The Rock's weight loss is a topic of public discussion [1] - The Rock discussed his health with Dr Mark Hyman [1] - The discussion with Dr Mark Hyman may cause people to rethink going to the doctor [1] Steroid Use & Health - Concerns raised about the long-term health effects of heroic doses of steroids, particularly for individuals in their 50s [1]

Switching gears, Eli Lily surging almost 6%. It led the S&P 500 today. Their obesity pill cleared yet another late stage trial.Patients with type 2 diabetes and obesity losing an average 10 a.5% of their body weight after 72 weeks is on the highest dose. For more on what may come next, city research managing director Jeff Meechum joining us now. Jeff, great to have you on the show.What did these results mean for Lily. >> Awesome. Thanks for having me, Brian.Um, yes. So, the results here are derisking from t ...

Drug Overview & Clinical Trial Data - Eli Lilly's oral obesity pill (oral orforglipron) shows patients with obesity and diabetes losing approximately 105% of their body weight [1] - The Attain 2 trial results, focusing on patients with both obesity and diabetes, align with expectations [5] - Three phase three results reported: Achieve 1 (pure diabetics, positive), Attain 1 (pure obese, fell short), and Attain 2 (obese and diabetics, in line) [4][5] Competitive Landscape - Nova Nordisk is a main competitor with an oral version of their GLP-1 called oral semaglutide [6] - Eli Lilly's oral drug has an advantage over Nova Nordisk's due to the absence of food restrictions [7] - Injectable products (Mounjaro and Zepbound) are likely to remain the workhorse products due to better efficacy and established brand [7][9] Market Dynamics & Future Trends - Patient preference will dictate market share, with some preferring the convenience of a pill [9][10] - A plausible scenario involves initial weight loss with injectables followed by maintenance with orals [11] - Geographic variation exists, with oral medications potentially more popular outside the US due to needle phobia [8][9]

Weight Management & GLP-1s - Serena Williams partners with Ro to use GLP-1s for weight management [2] - She has been trying to lose weight since her first child in 2017, despite consistent workouts and healthy eating [2][3][9] - Traditional methods like various diets and exercise routines were ineffective for her [4][5][6] - GLP-1s helped her achieve results while maintaining her existing healthy habits [10] - She emphasizes the health aspect and feeling lighter and more confident [18] - Ro provides easy access to medicine, doctor consultations, and insurance checks [15] - She hopes to reduce the stigma around weight loss medication and make it more accessible [17] Public Image & Haters - She addresses potential criticism for using GLP-1s, stating she doesn't care about haters [12][13] - She has faced criticism throughout her career and is good at blocking out noise [13][14] - She emphasizes the importance of sharing her story and journey [15] New Podcast: Stockton Street - Serena and Venus Williams are starting a podcast called Stockton Street, named after their childhood street in Compton [20] - The podcast will cover pop culture, sports, lifestyle, fashion, and design [23] - They aim to share open conversations and insights into their lives [23] Career & Resilience - She attributes her success to hard work and dedication [27] - She acknowledges the importance of resilience in tennis and life [29][30]

Health & Wellness Industry Trends - GLP-1s are gaining popularity as a weight loss solution [2] - Individuals are seeking medical interventions like GLP-1s after struggling with weight loss through traditional methods such as diet and exercise [1][2][3] - Personal experiences and testimonials are influencing decisions to try GLP-1s [2] GLP-1s & Weight Management - GLP-1s are perceived as a tool to achieve weight loss goals when other methods have failed [1][3] - GLP-1s can provide noticeable results, such as fitting into previously unwearable clothing [3] Public Perception & Personal Choice - Individuals may face criticism or judgment for using GLP-1s [3] - Personal health decisions should not be dictated by others' opinions [4]

Market Dynamics & Competition - Novo Nordisk's oral wegovy shows promising 16.6% weight loss with good tolerability, potentially shifting the oral market split [3][4] - The oral wegovy faces a "food effect" issue, requiring specific consumption conditions (fasting, water, waiting 30 minutes), potentially limiting its use to maintenance after initial weight loss with injectables [4][7] - Manufacturing costs for oral wegovy are higher due to the larger peptide dosage (25mg) compared to the weekly injectable (2.4mg) [7] - The weight loss drug space is experiencing pricing headwinds and some pricing concessions, potentially influenced by the CVS exclusive deal [8][9] Company Performance & Expectations - Lilly's stock experienced a significant drop (down 14%) due to data expectations being set too high (above 15% efficacy), raising questions about the long-term strength of their franchise [1][2] - There was a disconnect between Novo Nordisk's positive presentation of their data (27 pounds average weight loss) and the market's expectations [9] - Companies need to learn from competitors' successes and failures in managing expectations and messaging around drug data [13]

An experimental weight-loss pill from Eli Lilly helped people lose up to about 12% of their body weight, a new study found, potentially clearing the way for the drug to be on the market next year https://t.co/eihfsfp4I8 ...

Clinical Trial Results - Lilly's experimental pill resulted in patients shedding approximately 11% of their body weight [1] Market Expectations - The 11% weight loss result falls on the lower end of Wall Street's expectations [1]

Financial Data and Key Metrics Changes - Total cash and investments at year-end 2024 were reported at $132 million, expected to fund operations into the second half of 2026 [29] - R&D expenses for Q4 2024 were $19.8 million, up from $16.9 million in Q4 2023, with a full-year R&D expense of $82.2 million compared to $65.8 million in 2023 [30][32] - G&A expenses increased to $5.1 million in Q4 2024 from $4.3 million in Q4 2023, with a full-year G&A expense of $21 million compared to $18.1 million in 2023 [31][32] - Net loss for Q4 2024 was $23.2 million, an improvement from a net loss of $31.6 million in Q4 2023, while the full-year net loss was $95 million compared to $88 million in 2023 [31][32] Business Line Data and Key Metrics Changes - The company is focused on pemvidutide, with significant progress in the MASH (Metabolic Associated Steatotic Liver Disease) program, including the completion of enrollment in the Phase 2b IMPACT trial [9][10] - The upcoming Phase 2 trials for two additional indications are expected to start in mid-2025, following the clearance of INDs by the FDA [11][12] Market Data and Key Metrics Changes - The company anticipates that pemvidutide will be the first incretin-based agent to achieve fibrosis improvement at 24 weeks, positioning it favorably in the MASH treatment landscape [10][20] - The market for MASH is evolving, with increasing competition from agents like semaglutide and FGF21s, but pemvidutide's dual action on weight loss and liver health is expected to differentiate it [56][62] Company Strategy and Development Direction - The company plans to initiate a Phase 3 program in MASH in early 2026, contingent on positive data from the IMPACT trial [10][11] - The strategy includes leveraging the unique mechanism of action of pemvidutide to expand into additional indications while maintaining a primary focus on MASH [70][71] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones in 2025, including the Phase 2b readout in MASH and the initiation of Phase 2 trials for new indications [35][36] - The leadership transition is planned with the upcoming retirement of the Chief Medical Officer, ensuring continuity through key milestones [15][17] Other Important Information - A virtual R&D Day is scheduled for March 13, 2025, where the company will disclose additional indications and provide a detailed overview of future plans [12][35] - The company has added experienced members to its Board of Directors, enhancing its expertise in the pharmaceutical industry [13][14] Q&A Session Summary Question: Will details about the new indications be announced at the R&D Day? - Management confirmed that comprehensive information about the two new indications will be provided at the R&D Day, including plans for starting Phase 2 programs [38][39] Question: What are the expectations for the IMPACT trial regarding competitive success? - Management indicated that achieving statistical significance at 24 weeks would differentiate pemvidutide from other agents, as it would be the only incretin to attempt such a readout [54][59] Question: How does the company plan to address real-world adherence and discontinuation rates? - Management expressed confidence in competitive compliance and low discontinuation rates based on previous trial data, anticipating similar results in the IMPACT trial [111][112] Question: What is the strategy for prioritizing the development of pemvidutide across multiple indications? - The company plans to focus on MASH while pursuing additional indications, leveraging the dual mechanism of action of pemvidutide to validate its efficacy [70][71]