Viking Therapeutics FY Conference Summary Company Overview - **Company**: Viking Therapeutics (NasdaqCM: VKTX) - **Industry**: Biopharmaceuticals focusing on cardiometabolic diseases, particularly obesity and metabolic disorders [6][41] Key Points and Arguments Clinical Programs - Viking is developing novel therapeutics for metabolic and endocrine diseases, with a focus on obesity [6] - The lead program is **VK2735**, a dual agonist of GLP-1 and GIP receptors, currently in the **VANQUISH Phase III program** for obesity [7][41] - An oral formulation of VK2735 has completed a successful Phase II study, achieving primary and secondary endpoints [7][41] - An **amylin agonist** is planned to enter clinical trials by late 2025 or early 2026 [7][41] - Other compounds include **VK2809** for NASH and **VK0214** for X-linked adrenoleukodystrophy, which are available for licensing [8] Clinical Data Highlights - VK2735 has shown robust weight loss results, with up to **30% weight loss** observed in animal studies [10] - The oral formulation demonstrated an **8.2% reduction in body weight** after 28 days in Phase I trials, with a durable effect maintained at **8.3%** after 57 days [13][14][15] - The Phase II oral study showed a **12% weight loss** at the highest dose after 13 weeks, with a favorable tolerability profile [28] - The subcutaneous formulation achieved nearly **15% weight loss** after 13 weeks, with over **90% of adverse events** being mild to moderate [37] Future Plans - Viking plans to initiate a **subcutaneous to oral maintenance study** by late 2025 or early 2026 [29][43] - An end-of-Phase II meeting with the FDA is anticipated in Q4 2025 to discuss the path forward for the oral formulation [43][44] - The company aims to explore the combination of amylin with dual agonists to enhance weight loss efficacy [66] Market Position and Strategy - Viking operates with a lean structure, having over **$800 million** in cash to support ongoing trials [40][56] - The obesity market is evolving, with a significant shift towards direct-to-patient models, which Viking is well-positioned to leverage [56][70] - The company emphasizes the importance of efficacy and tolerability in its products to compete effectively in the market [64] Regulatory and Ethical Considerations - Current regulatory pathways require weight loss evidence for approval, with no specific path for maintenance therapies [46] - The company faces challenges in maintaining patient retention in placebo-controlled trials, which is critical for trial success [51][52] Additional Important Insights - The company has a strong focus on optimizing titration rates to minimize adverse events, particularly gastrointestinal issues [58][59] - Viking's strategy includes potential collaborations with larger companies for effective program development while maintaining the ability to operate independently [68] - The future vision includes having multiple products on the market and expanding internationally, utilizing a direct-to-patient model [70][71]

Group 1 - Viking Therapeutics' stock fell 42% on August 19, 2025, due to disappointing Phase 2 results for its oral obesity pill VK2735, which showed only up to 12.2% weight loss over three months, underperforming compared to competitors like Eli Lilly and Novo Nordisk [2] - 28% of patients discontinued VK2735 therapy due to side effects such as nausea and vomiting, indicating potential challenges in patient adherence [2] - Despite the setback with VK2735, Viking has a diversified pipeline with several promising candidates that may be undervalued by the market [3] Group 2 - Viking's current stock price of $24 is significantly below the analyst average price target of $89, suggesting a valuation disconnect that may not be justified given the company's diversified pipeline [3] - The Phase 3 trials for VK2735's subcutaneous formulation began in June 2025, and prior Phase 2 data indicated a viable injectable route with up to 13.1% placebo-adjusted weight loss [6] - Other pipeline assets include VK2809 for NASH/MASH, VK5211 for hip fracture recovery, VK0612 for type 2 diabetes, and VK0214 for X-linked adrenoleukodystrophy, contributing to further diversification [6] Group 3 - Key risks for Viking include potential clinical disappointments, substantial capital needs for Phase 3 trials, and intense competition in metabolic disorders [7] - For risk-tolerant long-term investors, the current valuation may over-penalize the company for the shortcomings of one program, presenting a speculative investment opportunity [7] - The conclusion suggests that if execution improves across other programs, the diversified pipeline could offer meaningful long-term upside [7]

Core Viewpoint - Viking Therapeutics is positioned to capitalize on opportunities in the competitive weight loss therapy market, especially following setbacks faced by larger competitors like Eli Lilly [2][5][7]. Company Overview - Viking Therapeutics is a mid-cap biotech company focusing on weight loss therapies, competing against established players such as Eli Lilly and Novo Nordisk [2][10]. - The company has a promising candidate, VK2735, currently in phase 3 studies, and is also developing an oral version of the drug in phase 2 trials [6][11]. Market Dynamics - The weight loss therapy market is becoming increasingly competitive, with major players needing to deliver exceptional clinical trial results to maintain their share prices [10]. - Eli Lilly's oral GLP-1 medicine, orforglipron, underperformed in a phase 3 study, creating a potential opportunity for Viking if its oral candidate meets expectations [7][8]. Clinical Developments - VK2735 showed strong phase 2 data, leading to a significant increase in Viking's stock last year, although it has since declined by 40% due to broader market volatility and profit-taking by long-term shareholders [5][12]. - Viking is also developing VK2809 for metabolic dysfunction-associated steatohepatitis (MASH), addressing a significant unmet medical need [11]. Investment Considerations - The stock has potential for significant upside if ongoing clinical trials yield positive results, particularly for the oral version of VK2735 [6][12]. - Investors are advised to consider their risk tolerance, as Viking, like other clinical-stage biotech companies, carries inherent risks [13][14].

Core Insights - Viking Therapeutics reported significant clinical and financial developments in Q2 2025, including the initiation of the Phase 3 VANQUISH program for VK2735, aimed at treating obesity and type 2 diabetes [2][4] - The company ended the quarter with a strong cash position of $808 million, supporting ongoing clinical trials and development programs [5][16] Clinical Pipeline Updates - The VANQUISH Phase 3 program for VK2735 includes two studies targeting approximately 4,500 adults with obesity and 1,100 adults with type 2 diabetes, assessing the efficacy and safety of VK2735 administered weekly for 78 weeks [4][5] - The Phase 2 VENTURE-Oral Dosing study of VK2735's oral formulation completed enrollment with approximately 280 patients, with top-line results expected in the second half of 2025 [6][8] - VK2735 demonstrated statistically significant weight loss of up to 14.7% in previous trials, with a favorable safety profile [3][4] Financial Performance - Research and development expenses for Q2 2025 were $60.2 million, up from $23.8 million in Q2 2024, primarily due to increased clinical study costs [10][11] - General and administrative expenses rose to $14.4 million in Q2 2025 from $10.3 million in Q2 2024, driven by higher stock-based compensation [11] - The net loss for Q2 2025 was $65.6 million, compared to a net loss of $22.3 million in Q2 2024, reflecting increased operational costs [12] Balance Sheet Overview - As of June 30, 2025, Viking held cash, cash equivalents, and short-term investments totaling $808 million, a decrease from $903 million at the end of 2024 [16] - The total liabilities stood at $32.4 million, with stockholders' equity at $795.5 million [25]

Core Viewpoint - Investors are expected to focus on Viking Therapeutics' pipeline updates during the second-quarter 2025 results announcement on July 23, following a previous earnings miss of approximately 21% [1][6]. Company Overview - Viking Therapeutics currently has no marketed drugs, leading to an expected revenue of zero for the upcoming quarter. The Zacks Consensus Estimate predicts a loss of $0.44 per share [2][7]. Pipeline Developments - The company is advancing three key candidates: VK2735 for obesity, VK2809 for non-alcoholic steatohepatitis (NASH), and VK0214 for X-linked adrenoleukodystrophy (X-ALD) [2][5]. - The phase III VANQUISH program for VK2735 has commenced, focusing on a subcutaneous formulation for adult patients with or without type II diabetes (T2D) over 78 weeks. The program includes two studies: VANQUISH-1 targeting 4,500 participants and VANQUISH-2 targeting 1,100 participants [3][5]. - An oral formulation of VK2735 is being evaluated in a phase II VENTURE-Oral Dosing study, with data expected by the end of the year [4]. Clinical Development Updates - Investors are looking for updates on the dual amylin and calcitonin receptor agonist (DACRA) candidate, with plans to file an investigational new drug (IND) application for obesity by year-end [5]. - Updates on the NASH and X-ALD programs, including collaboration prospects, are also anticipated [5]. Earnings Performance - Viking's earnings history has been mixed, with two earnings beats and two misses over the last four quarters, resulting in a negative average surprise of 1.93%. The company's shares have decreased by 20% year-to-date, contrasting with a 2% decline in the industry [6][7].

Company Overview - Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders [3] - The company leverages its expertise in metabolism to create innovative therapeutics aimed at improving patients' lives [3] Clinical Programs - Viking's clinical programs include VK2735, a dual agonist of GLP-1 and GIP receptors, currently evaluated in a Phase 3 obesity program with two trials (VANQUISH-1 and VANQUISH-2) [3] - VK2735 has shown an encouraging safety and tolerability profile along with positive clinical benefits in Phase 1 and Phase 2 trials [3] - An oral formulation of VK2735 is also being evaluated in a Phase 2 trial for obesity [3] - VK2809, a small molecule selective thyroid hormone receptor beta agonist, has achieved primary and secondary endpoints in a Phase 2b study for NASH and fibrosis [3] - In a Phase 2a trial for NAFLD and elevated LDL-C, VK2809 demonstrated statistically significant reductions in LDL-C and liver fat compared to placebo [3] - The company is developing dual amylin and calcitonin receptor agonists (DACRAs) for obesity and metabolic disorders [3] - VK0214, another small molecule selective thyroid hormone receptor beta agonist, is in development for X-ALD and has shown safety and significant reductions in VLCFAs in a Phase 1b trial [3] Upcoming Events - Viking Therapeutics will release its financial results for Q2 2025 after market close on July 23, 2025 [1] - A conference call to discuss these results and corporate updates is scheduled for July 23, 2025, at 4:30 p.m. Eastern Time [2]

VK2735 (GLP-1/GIP Dual Agonist) for Obesity - The VENTURE Phase 2 obesity study achieved its primary endpoint, demonstrating a significant reduction in body weight after 13 weeks of treatment[7, 43] - In the VENTURE study, patients receiving VK2735 experienced up to a 14.7% reduction in body weight from baseline after 13 weeks[44, 61] - Up to 88% of patients in the VENTURE study experienced ≥10% weight loss at the 15mg dose after 13 weeks[50, 51] - Oral VK2735 Phase 1 study showed a dose-dependent reduction in body weight, with a significant reduction of 5.3% versus placebo at the highest dose after 28 days[74, 97] - The company plans to initiate a Phase 2 trial for oral VK2735 in obesity in the second half of 2024[7, 98] VK2809 (Selective Thyroid Receptor-β Agonist) for NASH/MASH - The VOYAGE Phase 2b trial achieved its primary endpoint, demonstrating a robust reduction in liver fat[7, 125] - In the VOYAGE study, patients experienced up to a 55% median reduction in liver fat at 12 weeks[113, 114] - Up to 85% of VK2809 patients experienced a response, defined as a ≥30% decrease in liver fat at Week 12 in the VOYAGE study[116, 117] VK0214 (Selective Thyroid Receptor-β Agonist) for X-ALD - VK0214 Phase 1 study demonstrated LDL-C reductions, with data indicating approximately a 20% reduction from baseline[136, 137] - A Phase 1b study of VK0214 in patients with X-linked adrenoleukodystrophy is ongoing, with data expected in the second quarter of 2024[7] Financial Status - As of December 31, 2023, the company's cash and short-term investments totaled $362.079 million[141] - The company's cash burn year-to-date as of December 31, 2023, was $76.835 million[141] - A follow-on offering in the first quarter of 2024 yielded gross proceeds of $630 million[141]

Group 1: CRISPR Therapeutics - CRISPR Therapeutics has developed Casgevy, the first gene-editing medicine approved using the CRISPR technique, but the stock has been on a downward trend since 2021 due to clinical progress, complexity of therapy administration, and unprofitability [3][4] - The company is targeting challenging areas such as type 1 diabetes and hard-to-treat cancers, with expected data readouts for ongoing clinical trials as early as this year, which could positively impact stock performance [5] - Casgevy has significant financial implications, with a treatment cost of $2.2 million in the U.S. and an estimated 60,000 patients in target geographies, indicating blockbuster potential [9] Group 2: Viking Therapeutics - Viking Therapeutics gained attention after strong phase 2 results for VK2735, an investigational weight management therapy, but has seen stock performance decline as investors took profits [10] - The anti-obesity therapy market is rapidly growing, and Viking's VK2735 has shown promising mid-stage data, with an oral formulation currently in Phase 2 studies [11] - Viking Therapeutics has a robust pipeline, including VK2809 for metabolic dysfunction-associated steatohepatitis entering phase 3 studies and VK0214 for X-linked adrenoleukodystrophy, which has received orphan drug designation [12][13]

Company Overview - Viking Therapeutics (VKTX) is a mid-cap biotech company whose shares have declined by 34% this year, indicating potential company-specific developments or broader market issues affecting its attractiveness [1] - The company is in the clinical stage, meaning it has no products on the market, generates no revenue, and is consistently unprofitable, which typically makes it less appealing to investors during periods of market volatility [2] Product Development - Viking Therapeutics is developing medicines in areas with high unmet needs, particularly in weight management, where the anti-obesity drug market is experiencing significant growth [4] - The leading candidate, VK2735, is a dual GLP-1/GIP agonist, competing in the same class as Eli Lilly's Zepbound, which is currently the market leader [4][5] - VK2735 has shown better results than most mid-stage candidates in weight management, suggesting strong potential despite the competition from larger drugmakers [5] Market Potential - Another mid-stage program, VK2809, has performed well in patients with metabolic dysfunction-associated steatohepatitis (MASH), a disease linked to obesity, which is becoming increasingly prevalent [6] - VK2809 could enter a relatively young market in the coming years, potentially generating significant sales [7] Strategic Partnerships - Viking Therapeutics has signed a multiyear manufacturing agreement with CordenPharma for VK2735, which includes the production of over a billion oral formulations and 200 million autoinjectors and syringes annually [7] - The total payments to CordenPharma will amount to $150 million through 2028, indicating that the company is planning for post-commercial activities for its leading candidate [8] Innovation Commitment - The company is also developing another weight management product in preclinical studies, which is a dual agonist mimicking the action of two gut hormones [9] - Viking Therapeutics' commitment to innovation is notable for a small biotech, although there are risks associated with the potential failure of its advanced programs in phase 3 studies [9]

Viking Therapeutics (VKTX) Conference Call Summary Company Overview - Viking Therapeutics is focused on developing novel therapeutics for metabolic and endocrine diseases, with a primary emphasis on metabolic disease programs, particularly the VK2735 program, a dual agonist of the GLP-1 and GIP receptors [3][40]. Key Programs and Developments - **VK2735 Program**: - Completed a Phase 2 study demonstrating significant weight loss at 13 weeks, with results showing a reduction in body weight from approximately 9% to 15% from baseline [14][15]. - Planning to move into Phase 3 trials later this month [3][25]. - An oral formulation of VK2735 is currently in Phase 2, having shown proof of concept in Phase 1 [4][40]. - An amylin agonist program is also in development, with an IND filing planned for later this year [4][40]. - **Phase 1 and Phase 2 Studies**: - Phase 1 studies indicated a dose-dependent weight loss of up to 8% after four doses, with good safety and tolerability profiles [12][24]. - The Phase 2 "Venture Study" targeted obese subjects, showing promising results in weight loss and a shift towards normal glycemic status in pre-diabetic patients [17][24]. Efficacy and Safety Data - VK2735 demonstrated a mean weight loss of 14.7% after 13 weeks of treatment, with over 90% of treatment-emergent adverse events classified as mild to moderate [24][25]. - GI tolerability was assessed, showing expected mild to moderate adverse events such as nausea and vomiting, primarily occurring early in the treatment [19][20][33]. Future Plans - Initiating two Phase 3 studies this month: one for patients with obesity and another for those with obesity and type 2 diabetes [25][26]. - A maintenance study is planned to evaluate the transition from weekly to monthly dosing regimens [27][42]. - Development of a tablet formulation is ongoing, with a Phase 2 study called "Venture Oral" initiated, which includes multiple dosing arms [35][36]. Supply Chain and Financials - Viking Therapeutics has secured a long-term supply agreement with Cordon Pharma, ensuring access to a multi-ton annual supply of active pharmaceutical ingredients (API) and additional manufacturing capabilities [38][39]. - The company ended the first quarter with $850 million in cash, which is expected to support the registration program and further development of the oral program [39]. Market and Partnership Considerations - The company is open to partnerships but is also prepared to advance its programs independently if necessary [55]. - There is a maintained high level of interest from larger pharmaceutical companies in the obesity market, which is considered the largest market in pharmaceutical history [56][57]. Conclusion - Viking Therapeutics is advancing its VK2735 program with promising efficacy and safety data, preparing for Phase 3 trials, and exploring oral formulations while maintaining a strong financial position and supply chain capabilities [40].