Core Viewpoint - Viking Therapeutics is advancing in the weight-loss drug market with the initiation of its Phase 2 VENTURE-Oral trial for VK2735, aiming to leverage Eli Lilly's recent challenges and broaden treatment options beyond injections [1][5]. Group 1: Trial Details - The VENTURE-Oral trial commenced in January 2025 and will evaluate the safety, tolerability, pharmacokinetics, and weight-loss efficacy of a once-daily oral dose over a 13-week period [1][3]. - The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks, with secondary endpoints assessing additional safety and efficacy measures [3]. Group 2: Market Context - Eli Lilly's recent Phase 3 ATTAIN-1 trial for orforglipron showed underwhelming weight loss results, creating an opportunity for smaller competitors like Viking to fill the clinical gap [5]. - Analysts expect Viking to demonstrate the potential of VK2735's oral formulation as a competitive option in weight maintenance, with recommendations to buy shares before the Phase II readout [6]. Group 3: Expected Outcomes - Viking anticipates releasing trial results in the second half of 2025, with projections indicating a placebo-adjusted weight loss of slightly under 7% for the highest doses, based on Phase I results [4]. - Previous studies showed that patients receiving VK2735 achieved statistically significant mean body weight reductions of up to 14.7% from baseline and up to 13.1% relative to placebo [7].

Core Viewpoint - The enthusiasm for weight loss medications is increasing, with several companies, including Viking Therapeutics, Novo Nordisk, and Eli Lilly, preparing oral formulations to compete in a lucrative market [1][7]. Company Analysis Viking Therapeutics - Viking Therapeutics is developing VK2735, a novel dual agonist targeting GLP-1 and GIP receptors for metabolic disorders, currently in both subcutaneous and oral clinical trials [4]. - The phase 3 trial for the subcutaneous formulation began in June and will take 78 weeks, with results expected in 2027, while the phase 2 oral trial results are anticipated in 2025 [5]. - If the oral trial is successful, it is likely that a major pharmaceutical company may consider acquiring Viking [6]. Novo Nordisk - Novo Nordisk is a leading player in the weight loss market with its product Wegovy and is developing an oral version of it, which has shown similar weight loss results to the subcutaneous formulation [7][8]. - The FDA has accepted Novo Nordisk's submission for the oral formulation, with a decision expected in Q4 2025 [8]. Eli Lilly - Eli Lilly is developing Orforglipron, a small molecule drug, instead of an oral formulation of Zepbound, which is not suitable for oral delivery [9]. - Orforglipron has completed a successful phase 3 trial, achieving a mean weight loss of 12.4% at the highest dosage over 72 weeks, with plans to submit to the FDA by the end of the year [10]. Market Dynamics - The competition among Viking, Novo Nordisk, and Eli Lilly is intense, with the success of their respective oral formulations likely to influence investment decisions [11]. - The timelines for the release of phase 2 data from Viking and the FDA decisions for Novo Nordisk and Eli Lilly create a critical period for potential investment opportunities [11].

Core Viewpoint - Brokerage recommendations, particularly for Viking Therapeutics, Inc. (VKTX), show a strong positive bias, but their reliability in guiding investment decisions is questionable [5][10][11]. Group 1: Brokerage Recommendations - Viking Therapeutics has an average brokerage recommendation (ABR) of 1.22, indicating a consensus between Strong Buy and Buy, based on 18 brokerage firms [2]. - Out of the 18 recommendations, 16 are classified as Strong Buy, accounting for 88.9% of the total recommendations [2]. Group 2: Limitations of Brokerage Recommendations - Relying solely on brokerage recommendations may not be advisable, as studies indicate they often fail to identify stocks with the highest potential for price appreciation [5]. - Analysts from brokerage firms tend to exhibit a strong positive bias due to vested interests, leading to a disproportionate number of Strong Buy recommendations compared to Strong Sell [6][10]. - The ABR may not be up-to-date, while the Zacks Rank, which is based on earnings estimate revisions, provides a more timely and accurate reflection of stock price movements [13]. Group 3: Zacks Rank Comparison - The Zacks Rank categorizes stocks into five groups based on earnings estimate revisions, with a strong correlation to near-term stock price movements [8][11]. - Viking Therapeutics currently holds a Zacks Rank of 4 (Sell), reflecting a 27.4% decline in the Zacks Consensus Estimate for the current year to -$2.37, indicating growing pessimism among analysts [14][15].

Core Viewpoint - Viking Therapeutics is currently undervalued at a market cap of $3.7 billion, presenting a compelling investment opportunity in the weight loss drug sector, particularly as the company approaches critical clinical data releases for its oral VK2735 candidate [2][3][5]. Company Overview - Viking Therapeutics is focused on developing a dual GLP-1/GIP mechanism for weight loss, which has shown promising results in previous trials, including a 14.7% body weight reduction over 13 weeks with 88% of patients achieving at least 10% weight loss [6][10]. - The company is expected to report Phase 2 data for VK2735 in the second half of 2025, with September being the most likely timeframe [5]. Competitive Landscape - The obesity drug market is evolving, with competitors like Pfizer and Roche facing setbacks, creating an opportunity for Viking to capitalize on its differentiated approach [9][10]. - The market for obesity drugs is projected to reach $100 billion in annual sales by 2030, yet few companies have successfully developed oral alternatives, which could enhance Viking's strategic positioning [11]. Value Creation Pathways - Viking offers multiple avenues for value creation, including potential strategic partnerships or acquisition interest from major pharmaceutical companies facing patent cliffs [12][13]. - The company could also explore independent commercialization through innovative partnership models, such as subscription-based treatment platforms [14]. Market Dynamics - The competitive landscape has created a scarcity of advanced oral GLP-1 assets, making Viking's differentiated platform particularly attractive to potential acquirers, including Novo Nordisk [15][11]. - Viking's clean intellectual property position and manageable valuation further enhance its appeal as a target for companies looking to fill gaps in their obesity drug portfolios [13]. Upcoming Catalysts - The upcoming readout of VK2735 oral data is critical, as success could lead to various value creation scenarios, including strategic acquisitions or licensing partnerships [20][21]. - The dual-pathway approach of Viking addresses validated market needs, positioning the company favorably in a landscape with limited competition [19].

Core Insights - The healthcare industry remains a resilient sector for investors, particularly in biotech, which is known for innovation and life-saving products [1][2] Company Summaries Regeneron Pharmaceuticals - Regeneron Pharmaceuticals is projected to have a potential upside of 29% to 68% over the next 12 months, driven by its antibody-based therapies [4] - The company's top-selling product, Dupixent, achieved global net sales of $14.2 billion in 2024, a 22% increase from the previous year [5] - Eylea, another key product, generated $6 billion in U.S. net sales in 2024, maintaining its sales figures from 2023 [5] - Libtayo, an oncology drug, surpassed $1 billion in annual net sales in 2024, reflecting a 40% increase from the prior year [5] - Regeneron is advancing its pipeline with 45 product candidates in clinical development and expects several regulatory approvals in 2025 [8] - Recent approvals include Lynozyfic for multiple myeloma and several label expansions for Dupixent [8] - The company reported a first-quarter revenue of $3.03 billion, a 3.7% year-over-year decline, but net income increased by 12% to $809 million [7] Viking Therapeutics - Viking Therapeutics has a projected share price increase of 165% at the midpoint and up to 268% at the high end over the next year [11] - The lead candidate, VK2735, is a dual GLP-1 and GIP receptor agonist currently in phase 3 trials for obesity [11][12] - Viking is also developing an oral tablet formulation of VK2735 and plans to announce results from a phase 2 study in the second half of 2025 [12] - The company has other candidates targeting metabolic dysfunction and X-linked adrenoleukodystrophy (X-ALD) [13][14] - As a clinical-stage biopharmaceutical company, Viking is pre-revenue and has reported losses while preparing for commercialization [15] - The company had approximately $808 million in cash and equivalents at the end of Q2 [15]

Core Viewpoint - The article discusses the investment recommendation for Viking Therapeutics by The Motley Fool, highlighting its potential as a promising stock in the market [1] Company Summary - Viking Therapeutics is recommended by The Motley Fool, indicating a positive outlook for the company's stock performance [1]

Core Insights - JR Research is recognized as a top analyst in technology, software, and internet sectors, focusing on growth and GARP strategies [1] - The investment approach emphasizes identifying attractive risk/reward opportunities with robust price action to generate alpha above the S&P 500 [1][2] - The investment group Ultimate Growth Investing specializes in high-potential opportunities across various sectors with a focus on strong growth potential and contrarian plays [3] Investment Strategy - The strategy combines sharp price action analysis with fundamental investing, avoiding overhyped stocks while targeting battered stocks with recovery potential [2] - The investment outlook is typically 18 to 24 months for the thesis to materialize, aiming for robust fundamentals and attractive valuations [3] Target Audience - The group is designed for investors looking to capitalize on growth stocks with strong fundamentals, buying momentum, and turnaround plays [3]

Core Insights - Viking Therapeutics (VKTX) reported a second-quarter 2025 loss of $0.58 per share, which was wider than the Zacks Consensus Estimate of a loss of $0.44, and compared to a loss of $0.20 per share in the same quarter last year [1][7] - The company currently has no approved products and has not generated any revenues [1] Financial Performance - Research and development (R&D) expenses for the quarter were $60.2 million, a significant increase from $23.8 million in the prior year, driven by higher costs related to clinical studies and manufacturing, as well as increased employee-related expenses [2] - General and administrative expenses rose to $14.4 million, reflecting a 40% year-over-year increase, primarily due to higher employee-related costs [2] - As of June 30, 2025, Viking had cash, cash equivalents, and short-term investments totaling $808 million, down from $852 million as of March 31, 2025 [4] Market Reaction - Shares of VKTX fell 8% in after-market trading following the announcement of a wider-than-expected loss due to increased operating expenses [3] Future Guidance - Viking indicated that R&D expenses are expected to rise sequentially by approximately 25% to one-third in the third and fourth quarters of 2025 compared to the second quarter [5] Pipeline Developments - Viking is developing VK2735, a dual GLP-1 and GIP receptor agonist, for obesity treatment, with ongoing clinical studies for both oral and subcutaneous formulations [8] - The company launched the phase III VANQUISH program to evaluate VK2735 SC in adult patients, targeting enrollment of about 4,500 participants for VANQUISH-1 and around 1,100 for VANQUISH-2 [9] - An oral formulation of VK2735 is being evaluated in the phase II VENTURE-Oral Dosing study, with data expected by the end of the year [10] - Viking plans to file an investigational new drug application with the FDA in Q4 2025 for an internally developed amylin agonist program aimed at treating obesity [10]

Financial Data and Key Metrics Changes - Research and development expenses increased to $60.2 million for Q2 2025 from $23.8 million in Q2 2024, primarily due to clinical study costs and manufacturing expenses [8][9] - General and administrative expenses rose to $14.4 million for Q2 2025 from $10.3 million in Q2 2024, mainly due to stock-based compensation and salaries [9] - The net loss for Q2 2025 was $65.6 million, or $0.58 per share, compared to a net loss of $22.3 million, or $0.20 per share, in Q2 2024 [9] - For the first six months of 2025, research and development expenses totaled $101.5 million, up from $47.9 million in the same period in 2024 [10] - The net loss for the first half of 2025 was $111.2 million, or $0.99 per share, compared to a net loss of $49.6 million, or $0.46 per share, in the first half of 2024 [10][11] - Cash, cash equivalents, and short-term investments decreased to $8 million as of June 30, 2025, from $9 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - The VK2735 program for obesity is advancing with both oral and subcutaneous formulations, with the initiation of the Vanquish Phase III registration program [5][6] - The Phase II trial for the oral tablet formulation of VK2735 completed enrollment, with results expected later in the year [6][21] - The company is also progressing with a new program evaluating novel agonists of the amylin receptor, with an IND filing expected in Q4 2025 [22] Market Data and Key Metrics Changes - The Vanquish Phase III studies will evaluate VK2735 in adults with obesity and those with type 2 diabetes, targeting a total enrollment of approximately 4,500 and 1,100 participants, respectively [15][16] - The primary endpoint of the trials is the percent change in body weight from baseline after 78 weeks of treatment [16] Company Strategy and Development Direction - The company aims to provide both oral and subcutaneous formulations of VK2735 to cater to different patient preferences and mitigate safety challenges [17][18] - Viking Therapeutics is maintaining fiscal discipline and a strong balance sheet to support the advancement of VK2735 through Phase III trials and other key programs [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the strong demand for new weight loss therapeutics, indicating a positive outlook for the VK2735 program [23] - The company is focused on executing its core clinical strategy and is excited about the progress made in its development programs [5][6] Other Important Information - The company has achieved a comprehensive manufacturing agreement to support the potential commercialization of VK2735 [7] - Viking Therapeutics is preparing for the transition to auto injectors for VK2735 in early 2026, with plans for a bioequivalence study [110] Q&A Session Summary Question: Will the Phase II readout include data from all cohorts? - Yes, it will include all cohorts as it is a parallel cohort study [28] Question: Do you have an oral dose in mind for the monthly dosing study? - No specific dose has been determined yet as Phase II oral data is still pending [34] Question: Can you discuss the rationale for the top dose in the Phase III trial? - The decision to increase the top dose was based on encouraging tolerability and efficacy observed in previous studies [39] Question: What are the expectations for the oral Phase II data? - The company is looking for mid to high single-digit weight loss percentages, ideally around 8% [74] Question: How will placebo patients be motivated to stay in the study? - Regular visits and eligibility for open-label extensions are expected to help maintain participation [104] Question: What does the amylin agonist program need to show in Phase I? - The program should demonstrate impact on body weight and a favorable tolerability profile [124]

Financial Data and Key Metrics Changes - 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 and manufacturing expenses [7] - General and administrative expenses for Q2 2025 were $14.4 million, compared to $10.3 million in Q2 2024, driven by higher stock-based compensation and salaries [8] - The net loss for Q2 2025 was $65.6 million, or $0.58 per share, compared to a net loss of $22.3 million, or $0.20 per share in Q2 2024 [8] - For the first six months of 2025, research and development expenses totaled $101.5 million, up from $47.9 million in the same period in 2024 [9] - The net loss for the first half of 2025 was $111.2 million, or $0.99 per share, compared to a net loss of $49.6 million, or $0.46 per share in the first half of 2024 [9] - Cash, cash equivalents, and short-term investments as of June 30, 2025, were $800 million, down from $930 million at the end of 2024 [10] Business Line Data and Key Metrics Changes - The VK2735 program for obesity has advanced to Phase III with the initiation of the Vanquish registration program, which includes two trials targeting adults with obesity and those with type 2 diabetes [4][14] - The oral formulation of VK2735 has shown promising results in Phase I studies, achieving up to 8.2% weight loss after 28 days of daily dosing [18] - The VENTURE Phase II study for VK2735 demonstrated statistically significant weight loss effects, with reductions in mean body weight of up to 14.7% [12] Market Data and Key Metrics Changes - The company is focusing on the obesity market, which is seeing strong demand for new and differentiated weight loss therapeutics, as evidenced by rapid enrollment in VK2735 trials [22][23] - The competitive landscape includes other agents, but the company believes there is room for multiple products in the obesity treatment market [112] Company Strategy and Development Direction - The company is committed to advancing its clinical pipeline, particularly the VK2735 obesity program, while maintaining fiscal discipline and a strong balance sheet to support ongoing and future trials [21][22] - The strategy includes both subcutaneous and oral formulations of VK2735 to provide treatment options for patients [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for VK2735 to meet significant unmet needs in obesity treatment [22] - The company plans to file an IND for its amylin receptor agonist program in Q4 2025, indicating a commitment to expanding its pipeline [21] Other Important Information - The company has established a comprehensive manufacturing agreement to support the potential commercialization of VK2735 [6] - Management highlighted the importance of maintaining participant engagement in placebo groups during long-term studies [100] Q&A Session Summary Question: Will the Phase II readout include data from all cohorts? - Yes, it will include all cohorts as it is a parallel cohort study [28] Question: What is the rationale for the dosing in the Phase III trial? - The decision to increase the top dose to 17.5 mg was based on encouraging tolerability and efficacy observed in previous studies [37] Question: How will the company motivate placebo patients to remain in the study? - The eligibility for an open-label extension after the trial is expected to help maintain participation [100] Question: What are the expectations for the oral program's Phase II data? - The company is looking for significant weight loss and a favorable tolerability profile to consider advancing to Phase III [119]