Viking Therapeutics, Inc.

    VKTX ·NASDAQ ·Pharmaceutical Preparations ·Inc. in DE
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    This Annual Report on Form 10-K contains “forward-looking statements” as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, in connection with the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially and adversely from those expressed or implied by such forward-looking statements. Such forward-looking statements include estimates of our expenses, future revenue, capital requirements and our needs for additional financing; statements regarding our ability to develop, acquire and advance drug candidates into, and successfully complete, clinical trials and preclinical studies; statements concerning new product candidates; risks and uncertainties associated with our research and development activities, including our clinical trials and preclinical studies; our expectations regarding the potential market size and the size of the patient populations for our drug candidates, if approved for commercial use, and our ability to serve such markets; statements regarding our ability to maintain and establish collaborations or obtain additional funding; statements regarding developments and projections relating to our competitors and our industry and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. These statements are often identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may” or “will,” the negative versions of these terms and similar expressions or variations. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially and adversely from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K and in our other Securities and Exchange Commission filings. Furthermore, such forward-looking statements speak only as of the date of this report. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of such statement.

    Throughout this Annual Report on Form 10-K, unless the context otherwise requires, the terms “Viking,” “we,” “us” and “our” in this Annual Report on Form 10-K refer to Viking Therapeutics, Inc. and its subsidiaries.

    PART I

    Item 1. Business.

    Overview

    We are a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.

    In January 2022, we announced the initiation of a Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, clinical trial of VK2735, a novel dual agonist of the glucagon-like peptide 1, or GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP, receptors. VK2735 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

    In March 2023, we announced the completion of the Phase 1 trial. The study was a randomized, double-blind, placebo-controlled, SAD and MAD study in healthy adults. The primary objectives of the study included evaluation of the safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously and the identification of VK2735 doses suitable for further clinical development. Study investigators also evaluated the pharmacokinetics of single and multiple doses of VK2735. Based upon the results from this Phase 1 study, in September 2023, we initiated the VENTURE study, a Phase 2 clinical trial of VK2735 in patients with obesity.

    The Phase 2 VENTURE study was a randomized, double-blind placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735, administered subcutaneously, once weekly. The 13-week study enrolled adults who were obese (BMI >= 30 kg/m2) or adults who were overweight (BMI >= 27kg/m2) with at least one weight-related co-morbidity condition. The primary endpoint of the study was the percent change in body weight from baseline to week 13, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures. In October 2023, we announced completion of patient enrollment in the Phase 2 VENTURE study and on February 27, 2024, we announced that patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%.

    In June 2025, we announced the initiation of two Phase 3 clinical studies to evaluate the subcutaneous formulation of VK2735, VANQUISH-1 and VANQUISH-2. In November 2025, we announced completion of enrollment in the VANQUISH-1 study.

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    In March 2023, we announced the initiation of a Phase 1 clinical study to evaluate a novel oral formulation of VK2735. The study, which was an extension of our completed Phase 1 evaluation of subcutaneously administered VK2735, evaluated daily oral doses for 28 days. In March 2024, we announced that the 28-day MAD study results highlighted positive signs of clinical activity following treatment with oral VK2735. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to approximately 5.3%.

    In January 2025, we announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, and in August 2025, we announced positive top-line results from the trial. The Phase 2 VENTURE-Oral Dosing trial successfully achieved its primary and secondary endpoints, with patients receiving oral VK2735 demonstrating statistically significant reductions in body weight compared with placebo. Additionally, the trial showed oral VK2735 treatment to be safe and well-tolerated through 13 weeks of daily dosing with the majority of treatment emergent adverse events being categorized as mild or moderate. We expect to initiate Phase 3 Oral dosing studies in the third quarter of 2026.

    In October 2025, we announced the initiation of an exploratory Phase 1 maintenance dosing study of VK2735. This study is intended to explore the feasibility of various VK2735 maintenance dosing regimens utilizing either the oral tablet or the subcutaneous formulation to sustain the initial weight loss achieved following subcutaneous dosing. In January 2026, we announced completion of enrollment in this study.

    In March 2025, we entered into broad, multi-year manufacturing agreements, or the Manufacturing Agreements, with Corden Pharma Colorado, Inc. and its affiliates, or CordenPharma, covering both the active pharmaceutical ingredient, or API, and final finished product supply for VK2735.

    Under the terms of the Manufacturing Agreements, we have secured dedicated capacity for the annual manufacture and supply of multiple metric tons of VK2735 API. In addition, CordenPharma will provide fill/finish capacity for both the injectable and oral formulations of VK2735. This includes dedicated manufacturing lines and an annual commitment to supply 100 million autoinjectors and an additional 100 million vial and syringe products for the subcutaneous formulation, as well as an annual capacity of over one billion oral VK2735 tablets. These API and final finished product capacities are further expandable at Viking’s option. In exchange for dedicated API and fill/finish capacity, we will make prepayments to CordenPharma, to be paid over the period from 2026 to 2028. These prepayments will be fully credited against future orders.

    In 2024, we announced a new, internally developed Dual Amylin and Calcitonin Receptor Agonist, or DACRA, program for the treatment of obesity and highlighted the effects of treatment on body weight, food intake and metabolic profile in both healthy rats and in diet-induced obese mice. The results demonstrated that our DACRAs reduced food intake in lean rats in the period from 0 – 72 hours following a single subcutaneous dose. We plan to file an Investigational New Drug, or IND, application for this program in the first quarter of 2026.

    We are also developing VK2809, which is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, or TRß. In November 2019, we initiated the VOYAGE study, a Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH/MASH.

    The VOYAGE study was a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH/MASH and fibrosis ranging from stages F1 to F3. The primary endpoint of the study evaluated the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction, or MRI-PDFF, from baseline to week 12 in subjects treated with VK2809 as compared to placebo. Secondary objectives included evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.

    In January 2023, we announced completion of patient enrollment in the VOYAGE study and in May 2023 we reported that the VOYAGE study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared to placebo.

    In June 2024, we announced positive 52-week histologic data from the VOYAGE study with up to 75% of patients treated with VK2809 achieving NASH/MASH resolution with no worsening of fibrosis as compared to 29% for placebo (p=0.0001), up to 57% of VK2809-treated patients achieving ≥1-stage improvement in fibrosis with no worsening of NASH/MASH as compared to 34% for placebo (p<0.05) and up to 48% of VK2809-treated patients achieving both resolution of NASH/MASH and a ≥1-stage improvement in fibrosis as compared to 20% for placebo (p=0.01). Adverse events, including gastrointestinal-related adverse events, were similar among VK2809-treated patients vs. placebo at week 52 and consistent with prior data reported at week 12. VK2809 has been evaluated in eight completed clinical studies, which enrolled more than 400 subjects.

    We are also developing VK0214, which is also an orally available, tissue and receptor-subtype selective agonist of TRß for X-linked

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    adrenoleukodystrophy, or X-ALD, a rare X-linked, inherited neurological disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells. The disease, for which there is no approved treatment, is caused by mutations in a peroxisomal transporter of very long chain fatty acids, or VLCFA, known as ABCD1. As a result, transporter function is impaired and patients are unable to efficiently metabolize VLCFA. The TRß receptor is known to regulate expression of an alternative VLCFA transporter, known as ABCD2. Various preclinical models have demonstrated that increased expression of ABCD2 can lead to normalization of VLCFA metabolism. Preliminary data suggest that VK0214 stimulates ABCD2 expression in an in vitro model and reduces VLCFA levels in an in vivo model of X-ALD.

    In June 2021, we initiated a Phase 1b clinical trial of VK0214 in patients with X-ALD. This trial was a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with the adrenomyeloneuropathy, or AMN, form of X-ALD. The study enrolled patients across three cohorts: placebo, VK0214 20 mg daily, and VK0214 40 mg daily.

    The primary objectives of the study were to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period. Secondary objectives included an evaluation of the pharmacokinetics of VK0214 following 28 days of dosing in this population. An exploratory objective was to evaluate the effects of VK0214 on plasma levels of VLCFAs in subjects with AMN. In October 2024, we announced results from the Phase 1b clinical trial, which showed VK0214 to be safe and well-tolerated following once-daily dosing over the 28-day study period. In addition, significant reductions were observed in plasma levels of VLCFAs and other lipids, as compared to placebo. Our intent is to pursue partnering or licensing opportunities for VK0214 prior to conducting additional clinical studies.

    Other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM. In November 2017, we announced positive top-line results from a Phase 2 proof-of-concept clinical trial in 108 patients recovering from non-elective hip fracture surgery. Top-line data showed that the trial achieved its primary endpoint, demonstrating statistically significant, dose dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. The study also achieved certain secondary endpoints, demonstrating statistically significant increases in appendicular lean body mass and total lean body mass for all doses of VK5211, compared to placebo. VK5211 demonstrated encouraging safety and tolerability in this study, with no drug-related serious adverse events, or SAEs, reported. Our intent is to continue to pursue partnering or licensing opportunities for VK5211 prior to conducting additional clinical studies.

    Our Development Pipeline

    The following table highlights our current development pipeline:

    Key: TRß, thyroid receptor beta; NASH/MASH; GLP-1, glucagon-like peptide 1, GIP, glucose-dependent insulinotropic polypeptide; X-ALD, X-linked adrenoleukodystrophy.

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    VK2735

    Activation of the 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. More recently, research efforts have explored the potential co-activation of the GIP receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. VK2735 is a dual agonist of the GLP-1 and GIP receptors that we are developing for the potential treatment for various metabolic disorders. VK2735 is being developed in both subcutaneous and oral formulations for the potential treatment of various metabolic disorders such as obesity.

    VK2735 Subcutaneous

    Based upon the results of the Phase 2 VENTURE study and the previous Phase 1 subcutaneous study, in June 2025, we announced the initiation of our VANQUISH Phase 3 program, which includes two studies evaluating VK2735: one in adults with obesity, or the VANQUISH-1 study, and one in obese or overweight adults with type 2 diabetes, or the VANQUISH-2 study. Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study will target enrollment of adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. The VANQUISH-2 study will target enrollment of adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomized to one of four weekly treatment arms: VK2735 7.5 mg, VK2735 12.5 mg, VK2735 17.5 mg and placebo. The primary endpoint of the trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction. Each study will include an open-label extension allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period. In November 2025, we announced completion of enrollment in the VANQUISH-1 study.

    Phase 2 Clinical Data for VK2735 Subcutaneous

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    Financial statements

    data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .

    From 10-Q filed 2026-10-29 (period ending 2026-09-30).

    This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, in connection with the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially and adversely from those expressed or implied by such forward-looking statements. Such forward-looking statements include estimates of our expenses, future revenue, capital requirements and our needs for additional financing; statements regarding our ability to develop, acquire and advance drug candidates into, and successfully complete, clinical trials and preclinical studies; statements concerning new product candidates; risks and uncertainties associated with our research and development activities, including our clinical trials and preclinical studies; our expectations regarding the potential market size and the size of the patient populations for our drug candidates, if approved for commercial use, and our ability to serve such markets; statements regarding our ability to maintain and establish collaborations or obtain additional funding; statements regarding developments and projections relating to our competitors and our industry and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. These statements are often identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may” or “will,” the negative versions of these terms and similar expressions or variations. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially and adversely from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission, or SEC, filings. Furthermore, such forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of such statements.

    Throughout this Quarterly Report on Form 10-Q, unless the context otherwise requires, the terms “Viking,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Viking Therapeutics, Inc. and its subsidiaries.

    Overview

    We are a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.

    In January 2022, we announced the initiation of a Phase 1 single ascending dose, or SAD, and multiple ascending dose, or MAD, clinical trial of VK2735, a novel dual agonist of the glucagon-like peptide 1, or GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP, receptors. VK2735 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

    In March 2023, we announced the completion of the Phase 1 trial. The study was a randomized, double-blind, placebo-controlled, SAD and MAD study in healthy adults. The primary objectives of the study included evaluation of the safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously and the identification of VK2735 doses suitable for further clinical development. Study investigators also evaluated the pharmacokinetics of single and multiple doses of VK2735. Based upon the results from this Phase 1 study, in September 2023, we initiated the VENTURE study, a Phase 2 clinical trial of VK2735 in patients with obesity.

    The Phase 2 VENTURE study was a randomized, double-blind placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735, administered subcutaneously, once weekly. The 13-week study enrolled adults who were obese (BMI >= 30 kg/m2) or adults who were overweight (BMI >= 27 kg/m2) with at least one weight-related co-morbidity condition. The primary endpoint of the study was the percent change in body weight from baseline to week 13, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures. In October 2023, we announced completion of patient enrollment in the Phase 2 VENTURE study and on February 27, 2024, we announced that patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%. VK2735 demonstrated encouraging safety and tolerability following 13 weeks of once-weekly dosing.

    In June 2025, we announced the initiation of two Phase 3 clinical studies to evaluate the subcutaneous formulation of VK2735, VANQUISH-1 and VANQUISH-2. In November 2025, we announced completion of patient enrollment in the VANQUISH-1 study. In March 2026, we announced the completion of patient enrollment in the VANQUISH-2 study.

    In March 2023, we announced the initiation of a Phase 1 clinical study to evaluate a novel oral formulation of VK2735. The study, which was an extension of our completed Phase 1 evaluation of subcutaneously administered VK2735, evaluated daily oral doses for 28 days. In March 2024, we announced that the 28-day MAD study results highlighted positive signs of clinical activity following treatment with oral VK2735. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline,

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    ranging up to approximately 5.3%. Oral VK2735 demonstrated encouraging safety and tolerability following 28 days of once-daily dosing.

    In January 2025, we announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, and in August 2025, we announced positive top-line results from the trial. The Phase 2 VENTURE-Oral Dosing trial successfully achieved its primary and secondary endpoints, with patients receiving oral VK2735 demonstrating statistically significant reductions in body weight compared with placebo, ranging up to 12.2% from baseline. Additionally, the trial showed oral VK2735 treatment to be safe and well-tolerated through 13 weeks of daily dosing with the majority of treatment emergent adverse events being categorized as mild or moderate. In October 2026, we announced the initiation of the SUNRISE Phase 3 clinical program for oral VK2735.

    In October 2025, we announced the initiation of an exploratory maintenance dosing study of VK2735. This study is intended to explore the feasibility of various VK2735 maintenance dosing regimens utilizing either the oral tablet or the subcutaneous formulation to sustain the initial weight loss achieved following subcutaneous dosing. In September 2026, we announced positive top-line results from the first part of the study. After 21 weeks of weekly subcutaneous dosing, participants receiving VK2735 demonstrated mean weight loss of approximately 16% to 19%, compared with approximately 0% for placebo. Following transition to less frequent dosing for 12 weeks, participants maintained up to 97% of their weight loss with every-other-week dosing and up to 90% with monthly dosing, compared with 61% for placebo. VK2735 was well tolerated during the maintenance period, with rates of gastrointestinal-related adverse events comparable to placebo. In October 2026, we announced the initiation of the second part of this study evaluating both oral and additional subcutaneous maintenance dosing regimens of VK2735.

    In March 2025, we entered into broad, multi-year manufacturing agreements, or the Manufacturing Agreements, with Corden Pharma Colorado, Inc. and its affiliates, or CordenPharma, covering both the active pharmaceutical ingredient, or API, and final finished product supply for VK2735.

    Under the terms of the Manufacturing Agreements, we have secured dedicated capacity for the annual manufacture and supply of multiple metric tons of VK2735 API. In addition, CordenPharma will provide fill/finish capacity for both the injectable and oral formulations of VK2735. This includes dedicated manufacturing lines and an annual commitment to supply 100 million autoinjectors and an additional 100 million vial and syringe products for the subcutaneous formulation, as well as an annual capacity of over one billion oral VK2735 tablets. These API and final finished product capacities are further expandable at our option. In exchange for dedicated API and fill/finish capacity, we will make prepayments to CordenPharma, to be paid over the period from 2026 to 2028. These prepayments will be fully credited against future orders.

    In 2024, we announced a new, internally developed Dual Amylin and Calcitonin Receptor Agonist, or DACRA, program for the treatment of obesity and highlighted the effects of treatment on body weight, food intake and metabolic profile in both healthy rats and in diet-induced obese mice. The results demonstrated that our DACRAs reduced food intake in lean rats in the period from 0 – 72 hours following a single subcutaneous dose. In April 2026, we announced that we filed an IND application for our novel amylin agonist VK3019. In June 2026, we announced the initiation of a Phase 1 SAD clinical trial evaluating VK3019.

    We are also developing VK2809, which is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, or TRß. In November 2019, we initiated the VOYAGE study, a Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH/MASH.

    The VOYAGE study was a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH/MASH and fibrosis ranging from stages F1 to F3. The primary endpoint of the study evaluated the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction from baseline to week 12 in subjects treated with VK2809 as compared to placebo. Secondary objectives included evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.

    In January 2023, we announced completion of patient enrollment in the VOYAGE study and in May 2023 we reported that the VOYAGE study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared to placebo.

    In June 2024, we announced positive 52-week histologic data from the VOYAGE study with up to 75% of patients treated with VK2809 achieving NASH/MASH resolution with no worsening of fibrosis as compared to 29% for placebo (p=0.0001), up to 57% of VK2809-treated patients achieving ≥1-stage improvement in fibrosis with no worsening of NASH/MASH as compared to 34% for placebo (p<0.05) and up to 48% of VK2809-treated patients achieving both resolution of NASH/MASH and a ≥1-stage improvement in fibrosis as compared to 20% for placebo (p=0.01). Adverse events, including gastrointestinal-related adverse events, were similar among VK2809-treated patients vs. placebo at week 52 and consistent with prior data reported at week 12. VK2809 has been evaluated in eight completed clinical studies, which enrolled more than 400 subjects.

    We are also developing VK0214, which is also an orally available, tissue and receptor-subtype selective agonist of TRß for X-linked

    23


     

    adrenoleukodystrophy, or X-ALD, a rare X-linked, inherited neurological disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells. The disease, for which there is no approved treatment, is caused by mutations in a peroxisomal transporter of very long chain fatty acids, or VLCFA, known as ABCD1. As a result, transporter function is impaired and patients are unable to efficiently metabolize VLCFA. The TRß receptor is known to regulate expression of an alternative VLCFA transporter, known as ABCD2. Various preclinical models have demonstrated that increased expression of ABCD2 can lead to normalization of VLCFA metabolism. Preliminary data suggest that VK0214 stimulates ABCD2 expression in an in vitro model and reduces VLCFA levels in an in vivo model of X-ALD.

    In June 2021, we initiated a Phase 1b clinical trial of VK0214 in patients with X-ALD. This trial was a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with the adrenomyeloneuropathy, or AMN, form of X-ALD. The study enrolled patients across three cohorts: placebo, VK0214 20 mg daily, and VK0214 40 mg daily.

    The primary objectives of the study were to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period. Secondary objectives included an evaluation of the pharmacokinetics of VK0214 following 28 days of dosing in this population. An exploratory objective was to evaluate the effects of VK0214 on plasma levels of VLCFAs in subjects with AMN. In October 2024, we announced results from the Phase 1b clinical trial, which showed VK0214 to be safe and well-tolerated following once-daily dosing over the 28-day study period. In addition, significant reductions were observed in plasma levels of VLCFAs and other lipids, as compared to placebo. Our intent is to pursue partnering or licensing opportunities for VK0214 prior to conducting additional clinical studies.

    Other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In November 2017, we announced positive top-line results from a Phase 2 proof-of-concept clinical trial in 108 patients recovering from non-elective hip fracture surgery. Top-line data showed that the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in total lean body mass, less head, following treatment with VK5211 as compared to placebo. The study also achieved certain secondary endpoints, demonstrating statistically significant increases in appendicular lean body mass and total lean body mass for all doses of VK5211, compared to placebo. VK5211 demonstrated encouraging safety and tolerability in this study, with no drug-related serious adverse events reported. Our intent is to continue to pursue partnering or licensing opportunities for VK5211 prior to conducting additional clinical studies.

    We were incorporated under the laws of the State of Delaware on September 24, 2012. Since our incorporation, we have devoted most of our efforts towards conducting certain clinical trials and preclinical studies related to our VK2735 subcutaneous, VK2735 oral, VK3019, VK2809, VK0214 and VK5211 programs and towards raising capital and building infrastructure. We obtained exclusive worldwide rights to VK2809, VK0214 and VK5211 and certain other assets pursuant to an exclusive license agreement with Ligand Pharmaceuticals Incorporated, or Ligand. The terms of this license agreement are detailed in a Master License Agreement with Ligand, which we entered into on May 21, 2014, as amended, or the Master License Agreement. A summary of the Master License Agreement can be found under the heading “Agreements with Ligand—Master License Agreement” under Part I, “Item 1. Business” of our Annual Report on Form 10-K filed with the SEC on February 11, 2026.

    Financial Operations Overview

    Revenues

    To date, we have not generated any revenue. We do not expect to receive any revenue from any drug candidates that we develop unless and until we obtain regulatory approval for, and commercialize, our drug candidates or enter into collaborative agreements with third parties.

    Research and Development Expenses

    During the year ended December 31, 2025, we incurred $345.0 million in research and development expenses primarily related to our efforts in conducting the VK2735 Phase 3 VANQUISH-1 and VANQUISH-2 clinical trials, the VK2735 Phase 2 VENTURE clinical trial, the VK2735 Phase 1 subcutaneous clinical trial, the VK2735 Phase 1 oral clinical trial, the VK2809 Phase 2b VOYAGE clinical trial and the VK0214 Phase 1b clinical trial. During the nine months ended September 30, 2026, we incurred $432.7 million in research and development expenses primarily related to our efforts in conducting the VK2735 Phase 3 VANQUISH-1 and VANQUISH-2 clinical trials. We expect that our ongoing research and development expenses will consist of costs incurred for the development of our drug candidates, including, but not limited to:

    •
    employee- and consultant-related expenses, which will include salaries, benefits and stock-based compensation, and certain consultant fees and travel expenses;
    •
    expenses incurred under agreements with investigative sites and CROs, which will conduct a substantial portion of our research and development activities, including studies in NASH/MASH, on our behalf;

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    •
    payments to third-party manufacturers, which will produce our active pharmaceutical ingredients and finished products;
    •
    license fees paid to third parties for use of their intellectual property; and
    •
    facilities, depreciation and other allocated expenses, which will include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment and laboratory and other supplies.

    We expense all research and development costs as incurred.

    We manage and prioritize our research and development expenses dynamically based on scientific data, probability of successful technical development and regulatory approval, market potential and unmet medical need, available human and capital resources and other considerations. We regularly review our research and development activities and, as necessary, reallocate resources among our programs, product candidates and external opportunities that we believe will best support the long-term growth of our business. We do not track total research and development expenses by program, product candidate, or development phase.

    The following table provides a breakout of expenses by major cost type:

     

    Nine Months Ended September 30,

    (in thousands)

    2026

     

     

    2025

    Personnel, facility and equipment, and other overhead costs

    $

    37,310

     

     

    $

    21,378

    Clinical and other development costs

    $

    395,398

     

     

    $

    170,118

    Total

    $

    432,708

     

     

    $

    191,496

    The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming and the successful development of our drug candidates is highly uncertain. Our future research and development expenses will depend on the clinical success of each of our drug candidates, as well as ongoing assessments of the commercial potential of such drug candidates. In addition, we cannot forecast with any degree of certainty which drug candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. We expect to incur increased research and development expenses in the future as we continue our efforts towards advancing our VK2735 subcutaneous, VK2735 oral, VK3019, VK2809 and VK0214 programs and seek to advance our additional programs.

    General and Administrative Expenses

    Our general and administrative expenses have generally increased year-over-year as we have hired additional employees, issued additional equity awards, which has resulted in increased stock-based compensation expense, implemented certain systems to increase efficiency, and incurred additional costs for insurance, legal and accounting related to operating as a public company. We expect that our general and administrative expenses will continue to increase in the future in order to support our expected increase in research and development activities, including increased salaries and other related costs, stock-based compensation and consulting fees for executive, finance, accounting and business development functions. We also expect general and administrative expenses to continue to increase as a result of additional costs associated with being a public company, including expenses related to continued compliance with the rules and regulations of the SEC and The Nasdaq Stock Market LLC, additional insurance expenses, investor relations activities and other administration and professional services. Other significant costs are expected to include legal fees relating to patent and corporate matters, facility costs not otherwise included in research and development expenses, and fees for accounting and other consulting services.

    Other Income (Expense)

    Other income (expense) includes interest income earned from our cash, cash equivalents, restricted cash and short-term investments and interest expense related to the 2032 Notes, including amortization of debt issuance costs.

    Critical Accounting Policies and Estimates

    Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments related to our preclinical, nonclinical and clinical development costs and drug manufacturing costs, which we consider to be critical accounting estimates. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and

    25


     

    liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

    Our significant accounting policies are more fully described in Note 1 and Note 3 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

    Results of Operations

    Comparison of the Three Months Ended September 30, 2026 and 2025

    Research and Development Expenses

    The following table summarizes our research and development expenses for the three months ended September 30, 2026 and 2025 (in thousands, except % change).

     

     

    Three Months Ended September 30,

    $
    Change

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

    Research and development expenses

    $

    166,804

     

     

    $

    89,953

    $

    76,851

     

    85.4

    %

    The increase in research and development expenses during the three months ended September 30, 2026, as compared to the same period in 2025, was primarily due to increased expenses related to planned and ongoing clinical studies of $53.3 million, manufacturing for our drug candidates of $16.8 million, stock-based compensation of $8.4 million, salaries and benefits of $1.6 million and third-party consultants of $0.3 million, partially offset by a decrease in preclinical studies of $3.4 million.

    General and Administrative Expenses

    The following table summarizes our general and administrative expenses for the three months ended September 30, 2026 and 2025 (in thousands, except % change).

     

     

    Three Months Ended September 30,

    $
    Change

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

    General and administrative expenses

    $

    20,308

     

     

    $

    8,608

    $

    11,700

     

    135.9

    %

    The increase in general and administrative expenses during the three months ended September 30, 2026, as compared to the same period in 2025, was primarily due to increased expenses related to legal and patent services of $4.9 million, third-party consultants of $3.6 million, stock-based compensation of $2.2 million and salaries and benefits of $0.7 million. These increases reflect the company’s rapid overall growth compared with the same period in 2025.

    Total Other Income, Net

    The following table summarizes our total other income, net for the three months ended September 30, 2026 and 2025 (in thousands, except % change).

     

     

    Three Months Ended September 30,

    $
    Change

     

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

     

    Total other income, net

    $

    3,926

     

     

    $

    7,774

    $

    (3,848

    )

     

    (49.5

    )%

    Total other income, net for the three months ended September 30, 2026 and 2025 consisted primarily of interest income, partially offset by interest expense related to the 2032 Notes in 2026 and expense relating to the amortization of certain financing costs in 2025.

    26


     

    Comparison of the Nine Months Ended September 30, 2026 and 2025

    Research and Development Expenses

    The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025 (in thousands, except % change).

     

     

    Nine Months Ended September 30,

    $
    Change

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

    Research and development expenses

    $

    432,708

     

     

    $

    191,496

    $

    241,212

     

    126.0

    %

    The increase in research and development expenses during the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily due to increased expenses related to planned and ongoing clinical studies of $224.0 million, stock-based compensation of $8.8 million, manufacturing for our drug candidates of $8.3 million, salaries and benefits of $4.5 million and third-party consultants of $2.5 million, partially offset by a decrease in preclinical studies of $7.1 million.

    General and Administrative Expenses

    The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026 and 2025 (in thousands, except % change).

     

    Nine Months Ended September 30,

    $
    Change

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

    General and administrative expenses

    $

    51,126

     

     

    $

    37,108

    $

    14,018

     

    37.8

    %

    The increase in general and administrative expenses during the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily due to increased expenses related to third-party consultants of $9.0 million, legal and patent services of $4.2 million and salaries and benefits of $1.5 million, partially offset by a decrease in stock-based compensation of $1.7 million. These increases reflect the company’s rapid overall growth compared with the same period in 2025.

    Total Other Income, Net

    The following table summarizes our total other income, net for the nine months ended September 30, 2026 and 2025 (in thousands, except % change).

     

    Nine Months Ended September 30,

    $
    Change

     

    %
    Change

     

     

    2026

     

     

    2025

     

     

     

     

    Total other income, net

    $

    14,301

     

     

    $

    26,627

    $

    (12,326

    )

     

    (46.3

    )%

    Total other income, net for the nine months ended September 30, 2026 and 2025 consisted primarily of interest income, partially offset by interest expense related to the 2032 Notes in 2026 and expense relating to the amortization of certain financing costs in 2025.

    Liquidity and Capital Resources

    We have incurred losses and negative cash flows from operations and have not generated any revenues since our inception. As of September 30, 2026, we had cash, cash equivalents, restricted cash and short-term investments of $960.0 million. As such, we believe our cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund our operations through at least December 31, 2027, which is more than one year after the date of our filing of this Form 10-Q.

    Our primary use of cash is to fund operating expenses, which to date have consisted of the cost to obtain the license of intellectual property from Ligand, certain research and development expenses related to furthering the development of VK2735 subcutaneous, VK2735 oral, VK3019, VK2809, VK0214 and VK5211, and general and administrative expenses. Since we have not generated any revenues to date, we have incurred operating losses since our inception. Cash used to fund operating expenses is impacted by the timing of payment of these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

    In July 2026, we filed an automatic universal shelf registration statement on Form S-3 (File No. 333-297820) as a well-known seasoned issuer as defined in Rule 405 under the Securities Act of 1933, as amended, which became effective upon filing, or the 2026 Shelf Registration Statement. The 2026 Shelf Registration Statement allows us to offer an indeterminate amount of securities, including equity securities, debt securities, warrants, rights, units and depositary shares, from time to time as described in the 2026 Shelf Registration

    27


     

    Statement. The specific terms of any offering under the 2026 Shelf Registration Statement will be established at the time of such offering. The 2026 Shelf Registration Statement will expire on July 30, 2029.

    In July 2026, we entered into an At-The-Market Equity Offering Sales Agreement, or the ATM Agreement, with Stifel, Nicolaus & Company, Incorporated, Piper Sandler & Co., Cantor Fitzgerald & Co., Oppenheimer & Co. Inc. and Canaccord Genuity LLC, or collectively, the Agents, pursuant to which we may offer and sell, from time to time, through or to the Agents, as sales agent or principal, shares of our common stock, or the ATM Offering. Sales of common stock pursuant to the ATM Agreement, if any, will be made at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. The 2026 Shelf Registration Statement included a prospectus relating to the ATM Offering, or the ATM Prospectus. We have no obligation to sell any shares under the ATM Agreement, and we may at any time suspend offers under the ATM Agreement. From the date of the ATM Prospectus through September 30, 2026, 1,476,600 shares of our common stock were sold pursuant to the ATM Agreement and, as of September 30, 2026, we may sell shares of our common stock for remaining gross proceeds of up to $449.8 million from time to time pursuant to the ATM Prospectus.

    We previously had an automatic universal shelf registration statement on Form S-3, which expired on July 26, 2026, or the Prior Shelf Registration Statement, which included a prospectus, or the Prior ATM Prospectus, relating to the sale of up to $200.0 million of shares of our common stock under a prior At-The-Market Equity Sales Agreement, dated July 28, 2021, as amended, or the Prior ATM Offering. From the date of the Prior ATM Prospectus through July 26, 2026, 4,591,231 shares of our common stock were sold pursuant to the Prior ATM Offering.

    In September 2026, we completed concurrent public offerings pursuant to the 2026 Shelf Registration Statement consisting of (i) 9,035,714 shares of our common stock at a public offering price of $35.00 per share and (ii) $258.8 million aggregate principal amount of 2.00% convertible senior notes due 2032, or the 2032 Notes. The offerings included the full exercise of the underwriters’ option to purchase additional shares of common stock and the option to purchase additional 2032 Notes.

    We received gross proceeds of approximately $316.25 million from the sale of common stock and approximately $258.8 million from the issuance of the 2032 Notes. Net proceeds were approximately $296.9 million from the common stock offering and approximately $250.6 million from the 2032 Notes offering, after deducting underwriting discounts, commissions and estimated offering expenses.

    The 2032 Notes are senior, unsecured obligations of the Company and bear interest at a rate of 2.00% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, beginning on April 15, 2027. The 2032 Notes will mature on October 15, 2032, unless earlier converted, redeemed, or repurchased. The initial conversion rate is 19.7044 shares of common stock per $1,000 principal amount of 2032 Notes, which represents an initial conversion price of approximately $50.75 per share, subject to customary adjustments. For additional information regarding the 2032 Notes, see Note 9 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

    To date, our operations have been financed primarily by the sale of our securities and the issuance of the 2032 Notes.

    In February 2025, our board of directors authorized a stock repurchase program effective February 27, 2025, whereby we may purchase up to $250.0 million in shares of our common stock over a period of up to two years, or the 2025 Repurchase Program. In July 2026, our board of directors terminated the 2025 Repurchase Program and authorized a new stock repurchase program effective July 30, 2026, whereby we may purchase up to $500.0 million in shares of our common stock over a period of up to three years, or the New Repurchase Program. The New Repurchase Program may be carried out at the discretion of a committee of our board of directors through open market purchases, one or more Rule 10b5-1 trading plans, block trades and in privately negotiated transactions. We did not repurchase any shares of our common stock under the 2025 Repurchase Program or the New Repurchase Program during the nine months ended September 30, 2026.

    The following table summarizes our cash flows for the periods indicated below (in thousands):

     

     

    Nine Months Ended September 30,

     

     

    2026

     

     

    2025

     

    Cash used in operating activities

    $

    (377,342

    )

     

    $

    (193,395

    )

    Cash provided by investing activities

    $

    256,139

     

     

    $

    265,776

     

    Cash provided by financing activities

    $

    633,214

     

     

    $

    1,336

     

     

    28


     

    Cash Used in Operating Activities

    During the nine months ended September 30, 2026, cash used in operating activities of $377.3 million primarily reflected our net losses for the period, adjusted by non-cash charges such as stock-based compensation, amortization of investment premiums, amortization of right-of-use assets, interest expense related to operating lease liabilities and realized gain on investment as well as changes in our working capital accounts, primarily consisting of increases in accounts payable, accrued expenses and accrued interest, net of interest received on maturity of investments, partially offset by an increase in prepaid expenses and other current assets and a decrease in lease liability.

    During the nine months ended September 30, 2025, cash used in operating activities of $193.4 million primarily reflected our net losses for the period, adjusted by non-cash charges such as stock-based compensation, amortization of investment premiums, amortization of right-of-use assets, amortization of financing costs, interest expense related to operating lease liabilities and realized gain on investment as well as changes in our working capital accounts, primarily consisting of increases in accrued interest, net of interest received on maturity of investments, accounts payable, accrued expenses and lease liability, partially offset by an increase in prepaid expenses and other current assets.

    Cash Provided by Investing Activities

    During the nine months ended September 30, 2026, cash provided by investing activities of $256.1 million resulted primarily from the proceeds of maturities of investments of $372.4 million, partially offset by the purchase of investments of $154.8 million and sales of investments of $38.5 million.

    During the nine months ended September 30, 2025, cash provided by investing activities of $265.8 million resulted primarily from the proceeds of maturities of investments of $643.3 million, partially offset by the purchase of investments of $377.5 million.

    Cash Provided by Financing Activities

    During the nine months ended September 30, 2026, cash provided by financing activities was $633.2 million, which consisted of proceeds from the issuance of common stock, net of offering costs of $297.3 million in the September 2026 public offerings, proceeds from the 2032 Notes, net of issuance costs paid of $251.0 million, proceeds from our at-the-market offerings, net of fees, of $82.7 million and proceeds from certain option exercises and Employee Stock Purchase Plan, or ESPP, common stock issuance of $2.2 million.

    During the nine months ended September 30, 2025, cash provided by financing activities was $1.3 million, which consisted of proceeds from certain option exercises and ESPP common stock issuances.

    Future Funding Requirements

    As of the date of this Quarterly Report on Form 10-Q and based upon our current operating plan, we believe that we have sufficient capital to fund our operating and capital requirements for at least the next 12 months. We anticipate, however, that we will continue to generate losses for the foreseeable future, and we expect the losses to increase materially as we continue the development of, and seek regulatory approvals for, our drug candidates, and seek to commercialize any drugs for which we receive regulatory approval. We will need to raise additional capital to fund our operations and complete our ongoing and planned clinical trials. We expect to finance future cash needs through public or private equity or debt offerings; however, funding may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

    Our future capital requirements will depend on many factors, including, but not limited to:

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    Next expected filings

    • ~2027-02-05 10-K expected by 2027-02-08 (in 99 days)
    • ~2027-04-30 10-Q expected by 2027-05-15 (in 183 days)
    • ~2027-07-29 10-Q expected by 2027-08-13 (in 273 days)
    • ~2027-10-29 10-Q expected by 2027-11-13 (in 365 days)

    Predicted from historical filing cadence; not an SEC commitment.

    Recent SEC filings

    • 2026-10-29 10-Q Quarterly Report
    • 2026-10-28 8-K Earnings Release; Financial Statements and Exhibits
    • 2026-09-28 8-K Material Agreement Entered; Material Financial Obligation; Financial Statements and Exhibits
    • 2026-09-25 424B5 Prospectus Supplement
    • 2026-09-25 424B5 Prospectus Supplement
    • 2026-09-22 8-K Other Events; Financial Statements and Exhibits
    • 2026-07-30 S-3ASR S-3ASR
    • 2026-07-29 8-K Earnings Release; Financial Statements and Exhibits
    • 2026-07-29 10-Q Quarterly Report
    • 2026-04-30 10-Q Quarterly Report
    • 2026-04-29 8-K Earnings Release; Financial Statements and Exhibits
    • 2026-02-11 10-K Annual Report
    • 2026-02-11 8-K Earnings Release; Financial Statements and Exhibits
    • 2025-10-23 10-Q Quarterly Report
    • 2025-10-22 8-K Earnings Release; Financial Statements and Exhibits