Viking Therapeutics(VKTX) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Viking Therapeutics, a clinical-stage biopharmaceutical company, achieved significant clinical milestones in H1 2025 and maintains a strong financial position to advance its pipeline Company Overview Viking Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders. The CEO highlighted significant clinical milestones achieved in the first half of 2025 and a strong balance sheet to support ongoing development - Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders[2] - CEO Brian Lian highlighted significant execution and clinical milestones in H1 2025, including the initiation of the VK2735 Phase 3 VANQUISH program and completion of enrollment for the Phase 2 VENTURE-Oral Dosing study[3] - The company completed Q2 with a strong balance sheet, holding $808 million in cash, providing runway for advancing VK2735 through Phase 3 and supporting other key development programs[3][5][21] Highlights from the Quarter Ended June 30, 2025, and Other Recent Events Key achievements during the quarter include the initiation of Phase 3 trials for subcutaneous VK2735, completion of enrollment for the Phase 2 oral VK2735 study with results expected in 2H25, and continued progress on the amylin program with an IND planned for Q4 2025. The company also reported a strong quarter-end cash position - Phase 3 VANQUISH Registration Trials for VK2735 in Obesity are underway[5] - Enrollment for the Phase 2 VENTURE-Oral Dosing Trial is completed, with top-line results expected in 2H25[5] - Continued progress with the Amylin Program, with an IND planned for 4Q25[5] - Strong Quarter-End Cash Position of $808 million[5][21] Pipeline and Recent Corporate Highlights Viking Therapeutics is advancing its obesity pipeline with Phase 3 trials for subcutaneous VK2735, completed enrollment for oral VK2735 Phase 2, and an IND planned for its DACRA program Phase 3 VANQUISH Registration Trials for Subcutaneous VK2735 Underway Viking initiated the Phase 3 VANQUISH clinical program for subcutaneous VK2735, a dual GLP-1/GIP agonist, for obesity. This program includes two randomized, double-blind, placebo-controlled studies (VANQUISH-1 and VANQUISH-2) evaluating efficacy and safety over 78 weeks, building on positive Phase 2 VENTURE results - VK2735 is a wholly owned long-acting dual agonist of GLP-1 and GIP receptors for obesity and metabolic disorders[6] - Phase 2 VENTURE study showed statistically significant body weight reductions up to 14.7% after 13 weekly doses, with encouraging safety and tolerability[6] - The VANQUISH Phase 3 program includes two studies: VANQUISH-1 (approx. 4,500 adults with obesity/overweight with co-morbidity) and VANQUISH-2 (approx. 1,100 adults with type 2 diabetes and obesity/overweight)[7] - Primary endpoint for Phase 3 trials is percent change in body weight from baseline after 78 weeks[8] Phase 2 VENTURE-Oral Dosing Trial Enrollment Completed; Top-Line Results Expected 2H25 Enrollment for the Phase 2 VENTURE-Oral Dosing trial of VK2735 in subjects with obesity has been completed, with approximately 280 patients enrolled. Top-line results are anticipated in the second half of 2025. This oral formulation aims to provide a convenient treatment option and potential transition from subcutaneous therapy - Oral tablet formulation of VK2735 is being developed as an attractive treatment option, potentially allowing transition from subcutaneous formulation[9][10] - Phase 1 oral VK2735 trial demonstrated dose-dependent weight reductions up to 8.2% after 28 days and up to 8.3% at Day 57 follow-up, with encouraging safety and tolerability[11] - Phase 2 VENTURE-Oral Dosing trial, initiated in January 2025, is a randomized, double-blind, placebo-controlled study evaluating safety, tolerability, PK, and weight loss efficacy of once-daily oral VK2735 for 13 weeks[12] - Enrollment for the Phase 2 VENTURE-Oral trial was completed in March 2025, with approximately 280 patients, and results are expected in 2H25[13] Continued Progress with Dual Amylin and Calcitonin Receptor Agonist (DACRA) Program; IND Expected 4Q25 Viking is advancing its internally developed Dual Amylin and Calcitonin Receptor Agonist (DACRA) program for obesity, with an Investigational New Drug (IND) application planned for submission in the fourth quarter of 2025, supported by positive preclinical data showing reduced food intake and improved metabolic profiles in rodents - Viking announced a new, internally developed DACRA program for obesity in 2024, targeting amylin and calcitonin receptors[13] - In vivo data presented at ADA 2024 showed Viking's DACRAs reduced food intake and improved metabolic profile in rodents[13] - Viking plans to file an IND application for the DACRA program in Q4 2025[14] Upcoming Investor Events Viking management will participate in several investor conferences during July and September 2025, including BTIG Virtual Biotechnology, Cantor Global Healthcare, Morgan Stanley Global Healthcare, Bernstein's Healthcare Forum, and Stifel Virtual Cardiometabolic Forum - Viking management will participate in the following upcoming investor events: * BTIG Virtual Biotechnology Conference 2025 (July 29 – 30, 2025) * Cantor Global Healthcare Conference (September 3 – 5, 2025) * Morgan Stanley 23rd Annual Global Healthcare Conference (September 8 - 10, 2025) * Bernstein's 2nd Annual Healthcare Forum (September 23 - 25, 2025) * Stifel 2025 Virtual Cardiometabolic Forum (September 30, 2025)[14][15] Financial Results Viking Therapeutics reported increased net losses for Q2 and H1 2025, primarily driven by higher research and development and general and administrative expenses, while maintaining a strong cash position Second Quarter ended June 30, 2025 and 2024 For Q2 2025, Viking reported a net loss of $65.6 million ($0.58 per share), significantly higher than the $22.3 million net loss ($0.20 per share) in Q2 2024, primarily due to increased R&D and G&A expenses Second Quarter Financial Performance (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :----------- | | Research and development | $60,153 | $23,769 | +153.1% | | General and administrative | $14,421 | $10,285 | +40.2% | | Net loss | $(65,561) | $(22,250) | +194.6% | | Basic and diluted net loss per share | $(0.58) | $(0.20) | +190.0% | - Increase in R&D expenses primarily due to increased clinical studies, manufacturing, pre-clinical studies, stock-based compensation, and salaries and benefits[15] - Increase in G&A expenses primarily due to increased stock-based compensation and salaries and benefits, partially offset by decreased legal and patent services[16] Six Months Ended June 30, 2025 and 2024 For the first six months of 2025, Viking reported a net loss of $111.2 million ($0.99 per share), an increase from $49.6 million ($0.46 per share) in the same period of 2024, driven by higher R&D and G&A expenses, partially offset by increased interest income Six Months Financial Performance (H1 2025 vs H1 2024) | Metric | H1 2025 (in thousands) | H1 2024 (in thousands) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :----------- | | Research and development | $101,543 | $47,872 | +112.1% | | General and administrative | $28,500 | $20,255 | +40.7% | | Net loss | $(111,190) | $(49,606) | +124.1% | | Basic and diluted net loss per share | $(0.99) | $(0.46) | +115.2% | - Increase in R&D expenses primarily due to increased clinical studies, manufacturing, stock-based compensation, and salaries and benefits, partially offset by decreased pre-clinical studies[18] - Increase in G&A expenses primarily due to increased stock-based compensation, legal and patent services, and insurance, partially offset by decreased third-party consultants[19] Balance Sheet as of June 30, 2025 As of June 30, 2025, Viking held $808 million in cash, cash equivalents, and short-term investments, a decrease from $903 million at December 31, 2024. Total assets decreased to $827.9 million, while total liabilities increased to $32.4 million Balance Sheet Highlights (June 30, 2025 vs December 31, 2024) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Cash, cash equivalents and short-term investments | $807,724 | $902,612 | $(94,888) | | Total current assets | $827,017 | $907,216 | $(80,199) | | Total assets | $827,851 | $908,321 | $(80,470) | | Total current liabilities | $31,980 | $27,413 | +$4,567 | | Total liabilities | $32,390 | $28,043 | +$4,347 | | Total stockholders' equity | $795,461 | $880,278 | $(84,817) | Additional Information This section provides details on the upcoming Q2 2025 conference call, an overview of Viking Therapeutics' pipeline, forward-looking statement disclaimers, and condensed financial statements Conference Call Viking will host a conference call on July 23, 2025, at 4:30 p.m. ET to discuss Q2 2025 financial results, with replay and webcast options available - Conference call to discuss Q2 2025 financial results scheduled for July 23, 2025, at 4:30 p.m. ET[1][22] - Dial-in: (844) 850-0543 (U.S.) or (412) 317-5199 (International). Webcast available at **http://ir.vikingtherapeutics.com/webcasts**[22](index=22&type=chunk) About Viking Therapeutics, Inc. Viking Therapeutics is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. Its pipeline includes VK2735 (dual GLP-1/GIP agonist for obesity, subcutaneous in Phase 3, oral in Phase 2), VK2809 (selective thyroid hormone receptor beta agonist for NASH/fibrosis and NAFLD/elevated LDL-C), DACRAs for obesity, and VK0214 (selective thyroid hormone receptor beta agonist for X-ALD) - Viking is a clinical-stage biopharmaceutical company developing novel therapies for metabolic and endocrine disorders[23] - Key pipeline assets include: * VK2735: Dual GLP-1/GIP agonist for obesity (subcutaneous in Phase 3, oral in Phase 2) * VK2809: Selective thyroid hormone receptor beta agonist for NASH/fibrosis (Phase 2b successful) and NAFLD/elevated LDL-C (Phase 2a successful) * DACRAs: Internally developed dual amylin and calcitonin receptor agonists for obesity * VK0214: Selective thyroid hormone receptor beta agonist for X-linked adrenoleukodystrophy (X-ALD) (Phase 1b promising)[23][24] Forward-Looking Statements This section contains forward-looking statements subject to risks and uncertainties, including those related to clinical trial success, costs, timing, regulatory requirements, and the replication of prior results. Actual results may differ materially - Press release contains forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995[26] - Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including risks associated with clinical trial success, cost, timing, regulatory requirements, and replication of prior results[26] Condensed Consolidated Statements of Operations and Comprehensive Loss This table provides the unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, detailing revenues, operating expenses, other income/expense, net loss, and comprehensive loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | | | | Three Months Ended | | | | Six Months Ended | | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | | | June 30, | | | | June 30, | | | | 2025 | | | 2024 | | 2025 | | 2024 | | Revenues | $ | — | $ | — | $ | — | $ | — | | Operating expenses: | | | | | | | | | | Research and development | | 60,153 | | 23,769 | | 101,543 | | 47,872 | | General and administrative | | 14,421 | | 10,285 | | 28,500 | | 20,255 | | Total operating expenses | | 74,574 | | 34,054 | | 130,043 | | 68,127 | | Loss from operations | | (74,574) | | (34,054) | | (130,043) | | (68,127) | | Other income (expense): | | | | | | | | | | Amortization of financing costs | | (24) | | (18) | | (48) | | (46) | | Interest income, net | | 9,033 | | 11,820 | | 18,897 | | 18,565 | | Realized gain on investments, net | | 4 | | 2 | | 4 | | 2 | | Total other income, net | | 9,013 | | 11,804 | | 18,853 | | 18,521 | | Net loss | | (65,561) | | (22,250) | | (111,190) | | (49,606) | | Other comprehensive loss, net of tax: | | | | | | | | | | Unrealized gain (loss) on securities | | 26 | | (699) | | 589 | | (1,824) | | Foreign currency translation gain (loss) | | 24 | | 26 | | 33 | | (59) | | Comprehensive loss | $ | (65,511) | $ | (22,923) | $ | (110,568) | $ | (51,489) | | Basic and diluted net loss per share | $ | (0.58) | $ | (0.20) | $ | (0.99) | $ | (0.46) | | Weighted-average shares used to compute basic | | | | | | | | | | and diluted net loss per share | | 112,134 | | 110,390 | | 112,102 | | 106,924 | Condensed Consolidated Balance Sheets This table presents the unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | | June 30, | | | December 31, | | :--- | :--- | :--- | :--- | :--- | | | 2025 | | | 2024 | | | (Unaudited) | | | | | Assets | | | | | | Current assets: | | | | | | Cash and cash equivalents | $ | 33,880 | $ | 26,676 | | Short-term investments – available-for-sale | | 773,844 | | 875,936 | | Prepaid clinical trial and preclinical study costs | | 16,478 | | 3,476 | | Prepaid expenses and other current assets | | 2,815 | | 1,128 | | Total current assets | | 827,017 | | 907,216 | | Right-of-use assets | | 780 | | 1,003 | | Deferred financing costs | | 8 | | 56 | | Deposits | | 46 | | 46 | | Total assets | $ | 827,851 | $ | 908,321 | | Liabilities and stockholders' equity | | | | | | Current liabilities: | | | | | | Accounts payable | $ | 5,494 | $ | 9,813 | | Other accrued liabilities | | 26,018 | | 17,111 | | Lease liability, current | | 468 | | 489 | | Total current liabilities | | 31,980 | | 27,413 | | Lease liability, net of current portion | | 410 | | 630 | | Total long-term liabilities | | 410 | | 630 | | Total liabilities | | 32,390 | | 28,043 | | Commitments and contingencies | | | | | | Stockholders' equity: | | | | | | Preferred stock, $0.00001 par value: 10,000,000 shares authorized at June 30, 2025 | | | | | | and December 31, 2024; no shares issued and outstanding at June 30, 2025 and | | | | | | December 31, 2024 | | — | | — | | Common stock, $0.00001 par value: 300,000,000 shares authorized at June 30, 2025 | | | | | | and December 31, 2024; 112,329,709 shares issued and outstanding at June 30, 2025 | | | | | | and 111,573,519 shares issued and outstanding at December 31, 2024 | | 1 | | 1 | | Treasury stock at cost, no shares at June 30, 2025 and December 31, 2024 | | — | | — | | Additional paid-in capital | | 1,394,723 | | 1,368,972 | | Accumulated deficit | | (599,097) | | (487,907) | | Accumulated other comprehensive loss | | (166) | | (788) | | Total stockholders' equity | | 795,461 | | 880,278 | | Total liabilities and stockholders' equity | $ | 827,851 | $ | 908,321 | Contacts Provides contact information for Viking Therapeutics' Chief Financial Officer, Greg Zante, and for investor and media relations through Vida Strategic Partners - Viking Therapeutics Contacts: * Greg Zante, Chief Financial Officer: 858-704-4672, gzante@vikingtherapeutics.com * Vida Strategic Partners (Investors): Stephanie Diaz, 415-675-7401, sdiaz@vidasp.com * Vida Strategic Partners (Media): Tim Brons, 415-675-7402, tbrons@vidasp.com[31]