Viking Therapeutics Inc

Previous wording

The Phase 2 VENTURE study is 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 will enroll adults who are obese (BMI >= 30 kg/m2) or adults who are overweight (BMI >= 27kg/m2) with at least one weight-related co-morbidity condition. The primary endpoint of the study is 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%.

Current wording

The Phase 2 VENTURE study is 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 will enroll adults who are obese (BMI >= 30 kg/m2) or adults who are overweight (BMI >= 27kg/m2) with at least one weight-related co-morbidity condition. The primary endpoint of the study is 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%. Based on written feedback received from the U.S. Food and Drug Administration, or the FDA, we plan to advance the subcutaneous formulation of VK2735 into Phase 3 development.

Previous wording

On March 28, 2023, we announced the initiation of a Phase 1 clinical study to evaluate a novel oral formulation of VK2735. The study, which is an extension of our recently completed Phase 1 evaluation of subcutaneously administered VK2735, is evaluating daily oral doses for 28 days. On March 26, 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 5.3%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 3.3%. Based on these Phase 1 results, we plan to initiate a Phase 2 trial with the oral formulation of VK2735 in obesity later in 2024.

Current wording

On March 28, 2023, we announced the initiation of a Phase 1 clinical study to evaluate a novel oral formulation of VK2735. The study, which is an extension of our recently completed Phase 1 evaluation of subcutaneously administered VK2735, is evaluating daily oral doses for 28 days. On March 26, 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%. Based on these Phase 1 results, we plan to initiate a Phase 2 trial with the oral formulation of VK2735 in obesity later in 2024.

Previous wording

Our most advanced clinical program's drug candidate, VK2809, 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.

Current wording

Our most advanced clinical program's drug candidate, VK2809, 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 MASH/NASH.

Previous wording

The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3. The primary endpoint of the study will evaluate 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 include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.

Current wording

The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed MASH/NASH and fibrosis ranging from stages F1 to F3. The primary endpoint of the study will evaluate 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 include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.

Previous wording

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. Results from the biopsy after 52 weeks of dosing are expected to be available in the first half of 2024.

Current wording

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.

Previous wording

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 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 as compared to 34% for placebo (p<0.05) and up to 48% of VK2809-treated patients achieving both resolution of NASH and a ≥1-stage improvement in fibrosis as compared to 20% for placebo (p=0.01). Adverse events, including GI-related adverse events were similar among VK2809-treated patients vs. placebo at week 52 and consistent with prior data reported at week 12.

Current wording

In June 2024, we announced positive 52-week histologic data from the VOYAGE study with up to 75% of patients treated with VK2809 achieving MASH/NASH 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 MASH/NASH as compared to 34% for placebo (p<0.05) and up to 48% of VK2809-treated patients achieving both resolution of MASH/NASH and a ≥1-stage improvement in fibrosis as compared to 20% for placebo (p=0.01). Adverse events, including GI-related adverse events were similar among VK2809-treated patients vs. placebo at week 52 and consistent with prior data reported at week 12.

Previous wording

In June 2021, we initiated a Phase 1b clinical trial of VK0214 in patients with X-ALD. This trial is a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with the adrenomyeloneuropathy, or AMN, form of X-ALD. The study is initially targeting enrollment across three cohorts: placebo, VK0214 20 mg daily, and VK0214 40 mg daily. Pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued. Results from Phase 1b study are expected mid-year in 2024.

Current wording

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.

Previous wording

The primary objective of the study is to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period. Secondary and exploratory objectives include an evaluation of the pharmacokinetics and pharmacodynamics of VK0214 following 28 days of dosing in this population.

Current wording

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 and 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 very long-chain fatty acids, or 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.

Previous wording

During the year ended December 31, 2023, we incurred $63.8 million in research and development expense primarily related to our efforts in conducting the VK2735 Phase 2 VENTURE clinical trial, the VK2735 Phase 1 clinical trial, VK2809 Phase 2b VOYAGE clinical trial and the VK0214 Phase 1b clinical trial. During the six months ended June 30, 2024, we incurred $47.9 million to research and development expense primarily related to our efforts in continuing our Phase 1 SAD and MAD clinical trial of VK2735 for the treatment of various metabolic disorders, our efforts in preparing for the commencement of a Phase 3 clinical trial for subcutaneous VK2735 in obesity later this year, our efforts in concluding the VK2809 Phase 2b VOYAGE clinical trial and our efforts related to our Phase 1b clinical trial of VK0214 in patients with X-ALD. 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:

Current wording

During the year ended December 31, 2023, we incurred $63.8 million in research and development expense primarily related to our efforts in conducting the VK2735 Phase 2 VENTURE clinical trial, the VK2735 Phase 1 clinical trial, VK2809 Phase 2b VOYAGE clinical trial and the VK0214 Phase 1b clinical trial. During the nine months ended September 30, 2024, we incurred $70.7 million to research and development expense primarily related to our efforts in continuing our Phase 1 SAD and MAD clinical trial of VK2735 for the treatment of various metabolic disorders, our efforts in preparing for the commencement of a Phase 3 clinical trial for subcutaneous VK2735 in obesity, our efforts in concluding the VK2809 Phase 2b VOYAGE clinical trial and our efforts related to concluding our Phase 1b clinical trial of VK0214 in patients with X-ALD. 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:

Previous wording

expenses incurred under agreements with investigative sites and CROs, which will conduct a substantial portion of our research and development activities, including studies in obesity, NASH and X-ALD, on our behalf;

Current wording

expenses incurred under agreements with investigative sites and CROs, which will conduct a substantial portion of our research and development activities, including studies in obesity, MASH/NASH and X-ALD, on our behalf;

Previous wording

The increase in research and development expenses during the six months ended June 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, pre-clinical studies, stock-based compensation, salaries and benefits, services provided by third-party consultants and regulatory services.

Current wording

The increase in research and development expenses during the three months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation, salaries and benefits and regulatory services, partially offset by decreased expenses related to preclinical studies and clinical studies.

Previous wording

The increase in general and administrative expenses during the three months ended June 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to stock-based compensation and services provided by third-party consultants, partially offset by a decrease in expenses related to legal and patent services.

Current wording

The increase in general and administrative expenses during the three months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to stock-based compensation, legal and patent services, services provided by third-party consultants and insurance.

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands, except % change).

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands, except % change).

Previous wording

The increase in research and development expenses during the three months ended June 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, pre-clinical studies, salaries and benefits and stock-based compensation.

Current wording

The increase in research and development expenses during the nine months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock-based compensation, preclinical studies and salaries and benefits.

Previous wording

The following table summarizes our general and administrative expenses for the six months ended June 30, 2024 and 2023 (in thousands, except % change).

Current wording

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023 (in thousands, except % change).

Previous wording

The increase in general and administrative expenses during the six months ended June 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to stock-based compensation, salaries and benefits and services provided by third-party consultants, partially offset by a decrease in expenses related to legal and patent services.

Current wording

The increase in general and administrative expenses during the nine months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to stock-based compensation, salaries and benefits, services provided by third-party consultants and insurance, partially offset by decreased expenses related to legal and patent services.

Previous wording

The following table summarizes our other income (expense) for the six months ended June 30, 2024 and 2023 (in thousands, except % change).

Current wording

The following table summarizes our other income (expense) for the nine months ended September 30, 2024 and 2023 (in thousands, except % change).

Previous wording

Other income (expense) recognized during the six months ended June 30, 2024 and 2023 consisted primarily of interest income, partially offset by expense relating to the amortization of certain financing costs.

Current wording

Other income (expense) recognized during the nine months ended September 30, 2024 and 2023 consisted primarily of interest income, partially offset by expense relating to the amortization of certain financing costs.

Previous wording

We have incurred losses and negative cash flows from operations and have not generated any revenues since our inception. As of June 30, 2024, we had cash, cash equivalents and short-term investments of $942.3 million. As such, we believe our cash, cash equivalents and short-term investments will be sufficient to fund our operations through at least September 30, 2025, which is more than one year after the date of our filing of this Form 10-Q.

Current wording

We have incurred losses and negative cash flows from operations and have not generated any revenues since our inception. As of September 30, 2024, we had cash, cash equivalents and short-term investments of $930.4 million. As such, we believe our cash, cash equivalents and short-term investments will be sufficient to fund our operations through at least December 31, 2025, which is more than one year after the date of our filing of this Form 10-Q.

Previous wording

During the six months ended June 30, 2024, cash used in operating activities of $34.6 million primarily reflected our net losses for the period, adjusted by non-cash charges such as stock-based compensation, amortization of investment premiums, accrued expenses, prepaid expenses and other assets, amortization of right-of-use assets, amortization of financing costs, and interest expense related to operating lease liabilities as well as changes in our working capital accounts, primarily consisting of an increase in accrued interest, net of interest received on maturity of investments, partially offset by a decrease in amortization of investment premiums and decreases in accounts payable and lease liability.

Current wording

During the nine months ended September 30, 2024, cash used in operating activities of $56.6 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, realized gain on investment, amortization of financing costs, and interest expense related to operating lease liabilities as well as changes in our working capital accounts, primarily consisting of an increase in accrued expenses and accrued interest, net of interest received on maturity of investments, partially offset by decreases in accounts payable, prepaid expenses and other assets and lease liability.

Previous wording

During the six months ended June 30, 2023, cash used in operating activities of $36.1 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, and interest expense related to operating lease liabilities as well as changes in our working capital accounts, primarily consisting of an increase in accrued interest, net of interest received on maturity of investments, partially offset by a decrease in prepaid expenses and other assets and decreases in accounts payable, accrued expenses and lease liability.

Current wording

During the nine months ended September 30, 2023, cash used in operating activities of $55.7 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, and interest expense related to operating lease liabilities as well as changes in our working capital accounts, primarily consisting of an increase in accrued interest, net of interest received on maturity of investments, partially offset by a decrease in prepaid expenses and other assets and decreases in accounts payable, accrued expenses and lease liability.

Previous wording

During the six months ended June 30, 2024, cash used in investing activities of $585.9 million resulted primarily from the purchase of investments of $826.4 million, partially offset by the proceeds of maturities of investments of $240.6 million.

Current wording

During the nine months ended September 30, 2024, cash used in investing activities of $560.0 million resulted primarily from the purchase of investments of $976.4 million, partially offset by the proceeds of maturities of investments of $416.5 million.

Previous wording

During the six months ended June 30, 2023, cash used in investing activities of $202.3 million resulted primarily from the purchase of investments of $301.4 million, partially offset by the proceeds of maturities of investments of $99.1 million.

Current wording

During the nine months ended September 30, 2023, cash used in investing activities of $214.8 million resulted primarily from the purchase of investments of $380.8 million, partially offset by the proceeds of maturities of investments of $166.0 million.

Previous wording

During the six months ended June 30, 2024, cash provided by financing activities was $608.9 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $597.1 million in the March 2024 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $7.3 million and proceeds from the ATM Offering, net of fees, of $46.7 million, partially offset by value of shares withheld to cover taxes of $42.1 million.

Current wording

During the nine months ended September 30, 2024, cash provided by financing activities was $611.5 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $597.1 million in the March 2024 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $9.8 million and proceeds from the ATM Offering, net of fees, of $46.7 million, partially offset by value of shares withheld to cover taxes of $42.1 million.

Previous wording

During the six months ended June 30, 2023, cash provided by financing activities was $271.3 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $269.8 million in the April 2023 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $6.6 million and proceeds from the ATM Offering, net of fees of $2.0 million, partially offset by value of shares withheld to cover taxes of $7.1 million.

Current wording

During the nine months ended September 30, 2023, cash provided by financing activities was $271.2 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $269.8 million in the April 2023 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $6.6 million and proceeds from the ATM Offering, net of fees of $2.0 million, partially offset by value of shares withheld to cover taxes of $7.1 million.