Conference call scheduled for 4:30 p.m. ET today
-- Oral VK2735 to Advance into Phase 3 for Obesity in 3Q26
-- Phase 3 VANQUISH Trials for Subcutaneous VK2735 in Obesity Ongoing;
VANQUISH-1 Enrollment Complete, VANQUISH-2 Nearing Full Enrollment
-- VK2735 Maintenance Dosing Study Fully Enrolled; Data Expected 3Q26
-- Novel Amylin Agonist IND Filing Planned This Quarter
-- Strong Quarter-End Cash Position of $706 Million
SAN DIEGO, Feb. 11, 2026 /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 its financial results for the fourth quarter and year ended December 31, 2025, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter and Year Ended December 31, 2025, and Other Recent Events:
"The past year was an exceptional year for Viking marked by rapid progress across our obesity portfolio," stated Brian Lian, Ph.D., chief executive officer of Viking. "In June, the company initiated the Phase 3 VANQUISH clinical program evaluating the subcutaneous formulation of VK2735, a dual agonist of the GLP-1 and GIP receptors, for obesity. We announced completion of enrollment in VANQUISH-1 in the fourth quarter and expect to complete enrollment in VANQUISH-2 later this quarter. In 2025 the company also announced positive top-line results from its Phase 2 VENTURE-Oral dosing trial of the tablet formulation of VK2735 in obesity. Following feedback from an end-of-Phase 2 meeting with the FDA, we plan to advance oral VK2735 into Phase 3 development in 3Q26. Based on exciting early data suggesting the potential for maintenance dosing with VK2735, in the fourth quarter we initiated a study designed to evaluate monthly subcutaneous dosing, daily oral dosing, and weekly oral dosing. This trial will provide data to potentially further differentiate VK2735 as the only dual agonist molecule with the potential to dose monthly or to allow transition from subcutaneous to oral administration for weight maintenance. This study is fully enrolled and we look forward to announcing the results in the third quarter of 2026. We also expect to file an IND for our novel amylin agonist this quarter, expanding our obesity franchise. During the year Viking continued building the foundation to support commercial activities by entering into a comprehensive manufacturing and supply agreement for VK2735 and expanding our commercial depth to prepare for success. Throughout these activities we have continued to exercise fiscal discipline and maintain a strong balance sheet, which will allow us to meet key milestones in the quarters ahead. We expect 2026 to be another exciting and productive year and look forward to providing updates along the way."
Pipeline and Recent Corporate Highlights
-- Phase 3 VANQUISH Trials for Subcutaneous VK2735 in Obesity Ongoing;
VANQUISH-1 Fully Enrolled Ahead of Schedule, VANQUISH-2 Nearing Full
Enrollment. VK2735 is a wholly owned long-acting dual agonist of the
glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent
insulinotropic polypeptide, or GIP receptor, for the potential treatment
of obesity and other metabolic disorders. The company previously
announced positive top-line data from its Phase 2 VENTURE study of VK2735
in adults with obesity. This study demonstrated statistically significant
reductions in mean body weight from baseline, ranging up to 14.7% after
13 weekly doses. The VENTURE study also showed VK2735 to be safe and well
tolerated through 13 weeks of dosing, with the majority of treatment
emergent adverse events characterized as mild or moderate. Adverse events
generally occurred early in the course of treatment, resolved quickly,
and were primarily related to the expected gastrointestinal effects
resulting from activation of the GLP-1 receptor. In June 2025, following
an end-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA), the company initiated the VANQUISH Phase 3 registration program.
The VANQUISH program consists of two trials evaluating VK2735: one in
adults with obesity (VANQUISH-1) and one in adults with obesity and type
2 diabetes (VANQUISH-2). 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 was designed to target enrollment of
approximately 4,500 patients, and the VANQUISH-2 study is targeting
enrollment of approximately 1,100 patients. Participants in each of these
trials will be randomized to weekly VK2735 treatment arms of 7.5 mg, 12.5
mg, 17.5 mg, or placebo.The primary endpoint of the VANQUISH trials is
the percent change in body weight from baseline after 78 weeks of
treatment for participants receiving VK2735 as compared to placebo.
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 also include a one-year extension allowing participants the
opportunity to continue receiving treatment following completion of the
primary dosing period, including patients receiving placebo during the
initial portion of trial.In November 2025 the company announced
completion of enrollment in the VANQUISH-1 study. The trial enrolled more
than 4,500 patients, exceeding the original enrollment target, ahead of
schedule. The company believes the rapid pace of enrollment observed in
the VANQUISH program demonstrates the significant continued enthusiasm
among investigators, clinicians and patients for the VK2735 program.
Enrollment in the VANQUISH 2 study is continuing and the company expects
to complete enrollment in 1Q26.
-- Phase 2 VENTURE Data Highlighted in Presentations at ObesityWeek 2025 and
Published in Peer-Reviewed Journal, Obesity. The effects of weekly VK2735
on certain cardiometabolic parameters that were observed in the VENTURE
study were highlighted in a poster presentation at the 2025 ObesityWeek
conference in November. The results demonstrated that patients receiving
VK2735 experienced improvements in metabolic syndrome and prediabetic
status compared with patients receiving placebo. In addition, in January
2026 the full results of the VENTURE study were the subject of a
publication titled, "Weekly Subcutaneous VK2735, a GIP/GLP-1 Receptor
Dual Agonist, for Weight Management: Phase 2, Randomized, 13-Week VENTURE
Study," published in Obesity, the peer-reviewed journal of The Obesity
Society. This publication can be accessed online at:
https://onlinelibrary.wiley.com/doi/10.1002/oby.70106. The ObesityWeek
presentation and Obesity publication highlight VK2735's promising
efficacy, tolerability, and broader impact on improved cardiometabolic
status after a relatively short 13 week treatment window.
-- Oral VK2735 to Advance into Phase 3 Trials, Expected to Begin 3Q26. In
addition to the development of a subcutaneous formulation, Viking is also
advancing an oral tablet formulation of VK2735. The company believes the
availability of both an oral and an injectable formulation is an
important factor differentiating VK2735 from competitive agents, as no
other dual or triple agonist is currently available in both formulations.
The successful development of both a tablet and a subcutaneous injection
may represent an attractive option for those who prefer to initiate
treatment with an oral therapy, or for those seeking to maintain the
weight loss they have already achieved with an injectable therapy. Using
the same active ingredient in both formulations may reduce the risk of
unexpected side effects compared with switching between therapies that do
not share the same active agent.The company's prior Phase 1 and Phase 2
studies evaluating the oral tablet formulation of VK2735 successfully
achieved their objectives. Viking's Phase 1 study demonstrated
dose-dependent reductions in mean body weight from baseline, ranging up
to 8.2% after 28 days of daily dosing. The initial weight loss observed
in the Phase 1 study also showed encouraging durability, with up to 8.3%
reduction in body weight from baseline observed at follow-up visits
through Day 57, four weeks after the last dose was administered. The
study demonstrated encouraging safety and tolerability through 28 days of
once-daily dosing, at doses up to and including 100 mg, with the majority
of observed treatment emergent adverse events (TEAEs) reported as mild or
moderate, with most reported as mild. The company's Phase 2 VENTURE-Oral
Dosing study also successfully achieved its primary and secondary
endpoints, with impressive reductions in body weight observed, as well as
an encouraging safety and tolerability profile. This study was a
randomized, double-blind, placebo-controlled multicenter trial designed
to evaluate the safety, tolerability, pharmacokinetics and weight loss
efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The
primary endpoint of the study was the percent change in body weight from
baseline after 13 weeks of treatment.In the third quarter of 2025, the
company announced positive top-line results from the VENTURE-Oral Dosing
study, with statistically significant reductions in body weight observed,
along with promising safety and tolerability. Participants receiving once
daily doses of the oral tablet formulation of VK2735 demonstrated
reductions in mean body weight after 13 weeks, ranging up to 12.2% from
baseline. Weight loss was progressive at all doses through the course of
the study. Statistically significant differences compared to both
baseline and placebo were observed for all doses >15 mg starting at Week
1 and continuing throughout the 13-week treatment period. All doses of
VK2735 >15 mg also demonstrated statistically significant differences
relative to placebo on the key secondary endpoint assessing the
proportion of subjects demonstrating at least 5% and 10% weight loss. Up
to 97% of subjects in the VK2735 treatment groups achieved >=5% weight
loss, compared with 10% for placebo, and up to 80% of subjects in VK2735
treatment groups achieved >=10% weight loss, compared with 5% for
placebo.The VENTURE-Oral Dosing study included an exploratory dosing
cohort designed to assess weight loss maintenance. In this cohort,
participants were rapidly titrated to 90 mg daily doses. After four weeks
of daily dosing at 90 mg, participants were down-titrated to 30 mg daily
doses and maintained at 30 mg daily for seven weeks. Weight loss in this
cohort was shown to be rapid and progressive through the 90 mg treatment
period and was further extended following the transition to 30 mg daily
doses. The observed results suggest that effective weight maintenance may
be possible at doses <30 mg daily.The oral tablet formulation of VK2735
also demonstrated encouraging safety and tolerability following 13 weeks
of once-daily dosing. Among subjects receiving VK2735, 98% of reported
drug-related TEAEs were categorized as mild or moderate in severity. The
majority (99%) of gastrointestinal (GI)-related TEAEs were also reported
as mild or moderate. Consistent with the results of the subcutaneous
Phase 2 trial, GI-related adverse events were generally observed early in
treatment, with decreasing frequency upon repeat dosing.In December 2025,
Viking held an end-of-Phase 2 meeting with the FDA to discuss potential
next steps for oral VK2735. Based on feedback from the agency, the
company plans to advance oral VK2735 into Phase 3 development for obesity,
expected to begin in 3Q26.
-- VK2735 Phase 1 Maintenance Dosing Study Fully Enrolled; Data Expected
3Q26. Based on VK2735's extended plasma half-life and the availability of
both injectable and oral dosage forms, the company is evaluating a range
of novel dosing regimens for both the induction and the long-term
maintenance of weight loss. Providing flexible dosing options for
long-term therapy may improve treatment persistence following achievement
of individual weight loss goals. As mentioned above, Viking believes that
VK2735 is differentiated from currently available obesity treatments as
it represents the only option utilizing the same dual-acting GLP-1 and
GIP co-agonist molecule in both a subcutaneous and an oral formulation.
Providing patients the option to remain on the same active compound
throughout their treatment may reduce the potential for undesired side
effects compared with options that involve switching between different
therapeutic agents. The company believes this may lead to improved
adherence to therapy and increase the probability of realizing the
long-term benefits of weight loss such as reduced cardiovascular risks,
improved physical function and increased quality of life.In October 2025,
Viking initiated a Phase 1 study designed to explore the feasibility of
various VK2735 maintenance dosing regimens utilizing both the oral tablet
and the subcutaneous formulation. This trial is a randomized,
double-blind, placebo-controlled trial in approximately 180 adults with
obesity (BMI >=30 kg/m2). All participants will receive initial weekly
subcutaneous doses of VK2735 or placebo for 19 weeks. Following Week 19,
participants are transitioned to a range of VK2735 maintenance dosing
regimens including weekly, every other week, and monthly subcutaneous
dosing, as well as daily oral dosing, weekly oral dosing, or placebo. The
objectives of the study are to evaluate the safety, tolerability, and
pharmacokinetic $(PK)$ profile of VK2735 under these various dosing
regimens. Exploratory endpoints will assess change in body weight from
baseline, as well as change in body weight from Week 19 to the end of the
study at Week 31.In January 2026, Viking announced completion of
enrollment in the maintenance dosing study. The company expects to report
the results of the study in 3Q26.
-- IND for Dual Amylin and Calcitonin Receptor Agonist (DACRA) Planned for
1Q26. The amylin and calcitonin receptors play an important role in
regulating food intake and metabolic control, making them potential
therapeutic targets for obesity. Viking believes that dual activation of
the amylin and calcitonin receptors could represent an attractive
treatment option for patients who are not candidates for GLP-1
therapeutics due to tolerability or other reasons. The company has been
developing a series of potent agonists of the amylin and calcitonin
receptors, which could play an important role as both single agents or in
combination with GLP-1 or dual GLP-1/GIP agonists.The company plans to
file an Investigational New Drug $(IND)$ application for its lead amylin
agonist later this quarter.
-- Upcoming Investor Events. Viking management will participate in the
following upcoming investor events:Leerink Partners 2026 Global
Healthcare Conference Miami, FLMarch 8 -- 11, 20262026 Jefferies Biotech
on the Beach Summit Miami, FLMarch 10 -- 11, 2026Raymond James
Biotech/BioPharma Conference New York, NYApril 14, 2026
Fourth Quarter and Full-Year 2025 Financial Highlights
Fourth Quarter ended December 31, 2025 and 2024
Research and development expenses were $153.5 million for the three months ended December 31, 2025, compared to $31.0 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies.
General and administrative expenses were $11.3 million for the three months ended December 31, 2025, compared to $15.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation.
For the three months ended December 31, 2025, Viking reported a net loss of $157.7 million, or $1.38 per share, compared to a net loss of $35.4 million, or $0.32 per share, in the corresponding period in 2024. The increase in net loss for the three months ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income, compared to the same period in 2024.
Year Ended December 31, 2025 and 2024
Research and development expenses were $345.0 million for the year ended December 31, 2025, compared to $101.6 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, regulatory services and consultants, partially offset by decreased expenses related to preclinical studies.
General and administrative expenses were $48.4 million for the year ended December 31, 2025, compared to $49.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance and salaries and benefits.
For the year ended December 31, 2025, Viking reported a net loss of $358.5 million, or $3.19 per share, compared to a net loss of $110.0 million, or $1.01 per share, in the corresponding period in 2024. The increase in net loss for the year ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income, compared to the year ended December 31, 2024.
Balance Sheet as of December 31, 2025
At December 31, 2025, Viking held cash, cash equivalents and short-term investments of $706 million, compared to $903 million as of December 31, 2024.
Conference Call
Management will host a conference call to discuss Viking's fourth quarter and full-year 2025 financial results today at 4:30 pm Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until February 18, 2026, by dialing (855) 669-9658 from the U.S. and Canada, or (412) 317-0088 and entering conference ID #3246362. Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at http://ir.vikingtherapeutics.com/webcasts. An archive of the webcast will also be available on the Webcasts page of Viking's website for 30 days.
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 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.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin and other receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission including Viking's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.
Viking Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
--------------------- ----------------------
2025 2024 2025 2024
---------- --------- ---------- ----------
Revenues $ -- $ -- $ -- $ --
Operating
expenses:
Research and
development 153,459 30,987 344,955 101,644
General and
administrative 11,279 15,251 48,387 49,277
--------- -------- --------- ---------
Total operating
expenses 164,738 46,238 393,342 150,921
--------- -------- --------- ---------
Loss from
operations (164,738) (46,238) (393,342) (150,921)
--------- -------- --------- ---------
Other income
(expense):
Amortization of
financing costs -- (24) (56) (94)
Interest income,
net 7,035 10,844 33,704 40,940
Realized gain on
investments,
net 41 1 55 112
--------- -------- --------- ---------
Total other
income, net 7,076 10,821 33,703 40,958
--------- -------- --------- ---------
Net loss (157,662) (35,417) (359,639) (109,963)
Other
comprehensive
loss, net of
tax:
Unrealized gain
(loss) on
securities (10) (2,252) 1,119 (173)
Foreign currency
translation gain
(loss) 14 (168) 47 (226)
--------- -------- --------- ---------
Comprehensive loss $(157,658) $(37,837) $(358,473) $(110,362)
========= ======== ========= =========
Basic and diluted
net loss per
share $ (1.38) $ (0.32) $ (3.19) $ (1.01)
========= ======== ========= =========
Weighted-average
shares used to
compute basic
and diluted net
loss per share 114,005 111,344 112,667 109,037
========= ======== ========= =========
Viking Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
December 31, December 31,
2025 2024
-------------- --------------
Assets
Current assets:
Cash and cash equivalents $ 165,810 $ 26,676
Short-term investments --
available-for-sale 539,929 875,936
Prepaid clinical trial and
preclinical study costs 8,053 3,476
Prepaid expenses and other current
assets 1,806 1,128
---------- ----------
Total current assets 715,598 907,216
Right-of-use assets 85 1,003
Deferred financing costs -- 56
Deposits 46 46
---------- ----------
Total assets $ 715,729 $ 908,321
========== ==========
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 53,251 $ 9,813
Other accrued liabilities 23,279 17,111
Lease liability, current 137 489
---------- ----------
Total current liabilities 76,667 27,413
Lease liability, net of current
portion -- 630
---------- ----------
Total long-term liabilities -- 630
---------- ----------
Total liabilities 76,667 28,043
---------- ----------
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.00001 par value:
10,000,000 shares authorized at
December 31, 2025 and December 31,
2024; no shares issued and
outstanding at December 31, 2025 and
December 31, 2024 -- --
Common stock, $0.00001 par value:
300,000,000 shares authorized at
December 31, 2025 and December 31,
2024; 114,793,067 shares issued and
outstanding at December 31, 2025 and
111,573,519 shares issued and
outstanding at December 31, 2024 1 1
Treasury stock at cost, no shares at
December 31, 2025 and December 31,
2024 -- --
Additional paid-in capital 1,486,229 1,368,972
Accumulated deficit (847,546) (487,907)
Accumulated other comprehensive loss 378 (788)
---------- ----------
Total stockholders' equity 639,062 880,278
---------- ----------
Total liabilities and stockholders'
equity $ 715,729 $ 908,321
========== ==========
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SOURCE Viking Therapeutics, Inc.
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February 11, 2026 16:16 ET (21:16 GMT)