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Viking Therapeutics Highlights Clinical Data from VK2735 Obesity Program in Presentation at ObesityWeek® 2025

1. VK2735 improved cardiometabolic health after 13-week treatment. 2. 78% of VK2735 patients shifted to normal glycemic status. 3. 68% of MetS patients showed improvement using VK2735. 4. Significant weight loss observed in VK2735 treatment groups. 5. Positive data could enhance VKTX's market positioning.

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FAQ

Why Bullish?

The effective clinical results may attract investor interest, similar to GLP-1 therapies like Ozempic.

How important is it?

The positive trial results indicate a strong potential for VKTX's VK2735, impacting investor outlook and stock valuation.

Why Long Term?

As VK2735 progresses, it could secure market approval, boosting long-term stock performance.

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VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic Syndrome , /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that new clinical data from the company's VK2735 obesity program were highlighted in a poster presentation at ObesityWeek® 2025, the annual meeting of The Obesity Society.  VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors being developed for the potential treatment of various metabolic disorders.  Viking is evaluating both subcutaneous and oral formulations of VK2735 in clinical trials.  Results of an exploratory analysis of data from the company's Phase 2 VENTURE clinical trial of VK2735 dosed as a weekly subcutaneous injection were presented in a poster session on Thursday afternoon.  The exploratory analysis evaluated the impact of VK2735 treatment on the prevalence of prediabetes and metabolic syndrome (MetS) following the 13-week study.  Treatment with VK2735 was shown to improve cardiometabolic parameters in patients, including reductions in the prevalence of prediabetes and MetS at the end of the 13-week treatment period. Data from the study showed that 78% of VK2735-treated patients who were characterized as prediabetic at baseline had successfully shifted to normal glycemic status at Week 13, as compared to 29% for placebo patients (p=0.0008).  Shift in Diabetes Status from Baseline to Week 13 Parameter1 Placebo VK2735 2.5 mg VK2735 5 mg VK2735 10 mg VK2735 15 mg Combined VK2735 Arms Prediabetic at baseline2 14 21 21 16 16 74 Number shifting to normoglycemic at Week 133(%) 4 (29 %) 17 (81 %) 16 (76 %) 10 (63 %) 15 (94 %) 58 (78 %) p-value vs. placebo4 - 0.0036 0.0078 0.0697 0.0023 0.0008 Notes: 1) Observed values, no imputation for missing data. 2) Defined as patients with fasting plasma glucose 100 mg/dL to 125 mg/dL or HbA1c 5.7% to 6.4%. 3) Defined as fasting plasma glucose <100 mg/dL or HbA1c <5.7%. 4) Logistic regression model with treatment as the factor and baseline blood glucose as the covariate. Similarly, 68% of VK2735-treated patients who met the criteria for MetS at baseline were no longer considered to have the syndrome at Week 13, as compared to 38% for placebo patients (p=0.02). Shift in Metabolic Syndrome (MetS) Status from Baseline to Week 13 Parameter1 Placebo2 VK2735 2.5 mg2 VK2735 5 mg2 VK2735 10 mg2 VK2735 15 mg2 Combined VK27352 Arms MetS at baseline3 16 21 21 13 10 65 Number shifting to no MetS at Week 13(%) 6 (38 %) 14 (67 %) 14 (67 %) 10 (77 %) 6 (60 %) 44 (68 %) p-value vs. placebo4 - 0.1102 0.0217 0.0182 0.3892 0.0244 Notes: 1) Observed values, no imputation for missing data. 2) Includes all participants who met the criteria for MetS at baseline and enough MetS component Week 13 data collected to determine MetS status at end of study. 3) Defined as the presence of three or more metabolic abnormalities such as: a) waist circumference of more than 40 inches in men and 35 inches in women; b) serum triglycerides level of 150 mg/dL or greater; c) high-density lipoprotein cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women; d) elevated fasting glucose of l00 mg/dL or greater; e) systolic blood pressure of 130 mm Hg or higher or diastolic blood pressure of 85 mm Hg or higher. 4) Logistic regression models with treatment as the factor and baseline specified metabolic data as the covariate. These findings were reported at ObesityWeek in a poster presentation entitled, "Impact of Subcutaneous VK2735 on Weight, Prediabetes, and Cardiometabolic Status: The VENTURE Study." "The results of these analyses add another important layer to the impressive overall data reported from our Phase 2 VENTURE clinical trial.  Treatment with VK2735 rapidly improved glycemic status after the 13-week treatment period suggesting the potential to reduce the risk of transitioning from prediabetic to diabetic status.  The results also show VK2735's potential to help those with metabolic syndrome reverse the condition and potentially reduce the accompanying risk of cardiovascular disease," said Brian Lian, Ph.D., chief executive officer of Viking. "These data speak to the potential for VK2735 to improve patients' overall cardiometabolic health in addition to providing significant weight loss." A second ObesityWeek presentation highlighted the design of Viking's ongoing Phase 3 VANQUISH-1 study of subcutaneous VK2735 in patients with obesity or who are overweight with at least one weight-related co-morbid condition.  This presentation was titled: "VANQUISH-1 Study Design: Phase 3 Trial of Subcutaneous VK2735 in Adults with Overweight or Obesity."  The VANQUISH-1 study will evaluate changes in body weight as a primary endpoint as well as improvements in physical function, mental health, and productivity among patients receiving VK2735 as compared to placebo. As previously reported by Viking, patients receiving weekly doses of VK2735 in the VENTURE study demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses starting at Week One and continuing throughout the 13-week treatment period. Reductions in body weight were progressive through the course of the study, with no plateau observed for weight loss at 13 weeks. In addition, up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo. Additionally, as previously reported, the VENTURE study showed VK2735 treatment to have encouraging safety and tolerability following the 13-week treatment period with the majority (92%) of drug related treatment emergent adverse events (TEAEs) being categorized as mild or moderate. About GLP-1 and Dual GLP-1/GIP Agonists Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®. About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 2 trial in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com. SOURCE Viking Therapeutics, Inc.

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