The company provided clear evidence that it has plenty of resources to continue developing a potential blockbuster drug.Viking Therapeutics (VKTX 21.25%) was an outlier on the stock exchange Thursday, in the best way possible. Within its latest earnings release, the biotech had some encouraging news to report, and investors rewarded the company by sending its share price up by more than 21%. With that giant gain, the stock absolutely crushed the S&P 500 index, which only inched up by 0.2%.Third-quarter resu ...

Viking Therapeutics (VKTX) reported third-quarter 2024 loss per share of 22 cents, narrower than the Zacks Consensus Estimate of a loss of 24 cents. The company had incurred a loss of 23 cents per share in the year-ago quarter.Currently, Viking Therapeutics does not have any approved product in its portfolio. Hence, it is yet to generate revenues.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.More on VKTX’s Q3 EarningsResearch and development expenses totaled $22.8 million, up 24% ...

Financial Data and Key Metrics - Research and development expenses for Q3 2024 were $22.8 million, up from $18.4 million in Q3 2023, driven by increased manufacturing costs, stock-based compensation, and salaries [7] - General and administrative expenses for Q3 2024 were $13.8 million, up from $8.9 million in Q3 2023, primarily due to stock-based compensation, legal services, and third-party consulting [8] - Net loss for Q3 2024 was $24.9 million ($0.22 per share), compared to a net loss of $22.5 million ($0.23 per share) in Q3 2023 [8] - Cash, cash equivalents, and short-term investments stood at $930 million as of September 30, 2024, up from $362 million at the end of 2023 [11] Business Line Data and Key Metrics - VK2735 (obesity treatment): Phase 2 VENTURE trial showed up to 14.7% weight reduction after 13 weeks, with no plateau observed [13] - VK2809 (NASH and fibrosis treatment): Phase 2b VOYAGE trial achieved primary and secondary endpoints, with 63-75% NASH resolution rates and 44-57% fibrosis improvement rates [20] - VK0214 (X-ALD treatment): Phase 1b trial demonstrated safety and significant reductions in plasma levels of very long-chain fatty acids [24] - Oral VK2735: Phase 1 trial showed up to 5.3% weight reduction after 28 days, with dose escalation up to 100 mg completed [18][40] Market Data and Key Metrics - The obesity drug market is projected to exceed $40 billion in revenue, with injectable formulations expected to dominate (80% share) over oral formulations (20% share) [46] - The company is exploring monthly dosing for VK2735, which could serve as a maintenance regimen for weight management [32][65] Company Strategy and Industry Competition - The company plans to advance VK2735 into Phase 3 development for obesity, with an end-of-Phase 2 meeting scheduled with the FDA [15] - A new amylin agonist program is under development, with potential for combination therapy with VK2735 to enhance efficacy [26][36] - The company is evaluating partnerships for the NASH program (VK2809) and is in discussions with global peptide suppliers for long-term manufacturing capacity [42][56] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong balance sheet, which provides sufficient runway to execute key clinical milestones [25] - The company is optimistic about the potential of its pipeline, particularly the dual agonist VK2735 and the amylin agonist program, which could offer best-in-class efficacy [36][62] Other Important Information - The company submitted abstracts for the VENTURE and oral VK2735 Phase 1 trials for presentation at the ObesityWeek conference in November [14][18] - Results from the VOYAGE study will be presented at the AASLD Annual Meeting in November [22] Q&A Session Summary Question: End-of-Phase 2 meeting for VK2735 - The company plans to discuss trial design, dosing, and size with the FDA, aiming to finalize the Phase 3 protocol [29] Question: Monthly dosing for VK2735 - PK data supports monthly dosing, but it will likely be tested in a standalone study rather than included in the Phase 3 trial [32] Question: Oral VK2735 dosing regimens - The company is exploring additional dosing regimens and will disclose the Phase 2 study design closer to initiation [33] Question: Manufacturing capacity and infrastructure - The company is expanding its internal team and relying on external vendors to support upcoming Phase 3 trials [33] Question: Active control arm in Phase 3 - The Phase 3 study will be placebo-controlled, with potential for active comparator studies in the future [35] Question: Amylin agonist development strategy - The company plans to test the amylin agonist in combination with VK2735, with clinical trials expected to begin in 2025 [36] Question: Auto-injector for VK2735 Phase 3 - The company plans to use an auto-injector in the Phase 3 trial, with discussions ongoing to secure materials [50] Question: X-ALD program next steps - The next step for VK0214 is likely a registrational study, potentially focusing on functional or quality-of-life endpoints [52] Question: Maintenance dosing for VK2735 - Monthly dosing is viewed as a maintenance regimen, with potential to transition patients from weekly to monthly dosing [65] Question: Amylin and calcitonin receptor agonism - The company is targeting a balanced mechanism for its amylin agonist, as compounds with balanced receptor activity show better weight loss profiles [68]

Research and Development - The company incurred $70.7 million in research and development expenses during the nine months ended September 30, 2024, primarily for VK2735, VK2809, and VK0214 clinical trials [88]. - VK2735 demonstrated statistically significant mean body weight reductions of up to 14.7% from baseline in the Phase 2 VENTURE study after 13 weeks [78]. - VK2809 achieved a primary endpoint in the VOYAGE study, with significant reductions in liver fat content from baseline to Week 12 compared to placebo [80]. - In the VOYAGE study, up to 75% of VK2809-treated patients achieved MASH/NASH resolution with no worsening of fibrosis, compared to 29% for placebo (p=0.0001) [81]. - VK0214 showed significant reductions in plasma levels of very long-chain fatty acids in a Phase 1b clinical trial, indicating its potential efficacy for X-ALD [85]. - The Phase 2 VENTURE study for VK2735 enrolled adults with obesity or overweight, with a primary endpoint focused on percent change in body weight [78]. - The company plans to advance VK2735 into Phase 3 development based on FDA feedback following positive Phase 2 results [78]. Financial Performance - The company has not generated any revenue to date and does not expect to until drug candidates are approved and commercialized [88]. - Research and development expenses for Q3 2024 increased by 24.0% to $22.8 million compared to $18.4 million in Q3 2023, primarily due to higher manufacturing costs and stock-based compensation [94]. - General and administrative expenses for Q3 2024 rose by 55.0% to $13.8 million from $8.9 million in Q3 2023, mainly driven by increased stock-based compensation and legal services [95]. - Total other income for Q3 2024 was $11.6 million, a significant increase of 145.5% from $4.7 million in Q3 2023, primarily due to interest income [96]. - Research and development expenses for the nine months ended September 30, 2024, totaled $70.7 million, reflecting a 63.2% increase from $43.3 million in the same period of 2023 [97]. - General and administrative expenses for the nine months ended September 30, 2024, were $34.0 million, up 20.5% from $28.2 million in the prior year [98]. - Total other income for the nine months ended September 30, 2024, reached $30.1 million, a 194.0% increase from $10.3 million in the same period of 2023 [99]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of $930.4 million, expected to fund operations through at least December 31, 2025 [100]. - Cash used in operating activities for the nine months ended September 30, 2024, was $56.6 million, compared to $55.7 million in the same period of 2023 [108][109]. - Cash used in investing activities for the nine months ended September 30, 2024, was $560.0 million, significantly higher than $214.8 million in the same period of 2023 [110]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $611.5 million, compared to $271.2 million in the same period of 2023, primarily from stock offerings [111]. - As of September 30, 2024, cash and cash equivalents totaled $50,347,000, down from $55,516,000 on December 31, 2023 [117]. - Short-term investments available-for-sale increased significantly to $880,093,000 from $306,563,000 [117]. - Total cash and short-term investments reached $930,440,000, compared to $362,079,000 at the end of 2023 [117]. - A 10% increase or decrease in short-term interest rates would result in an annual interest income change of approximately $1.4 million [117]. - The investment portfolio is primarily composed of U.S. government securities, investment-grade corporate bonds, and money market funds [114]. - The company has implemented guidelines to limit the term-to-maturity of its investment instruments to manage interest rate risk [115]. - Interest income from cash and short-term investments will vary with fluctuations in U.S. interest rates [116]. - The company does not believe that the fair value of its investments has a material exposure to interest rate risk due to the conservative nature of the instruments [115]. - The investment portfolio is used to preserve capital, provide liquidity, and earn returns aligned with the company's risk appetite [114]. - The company accounts for its securities as available-for-sale, realizing gains or losses only upon sale or credit loss [115].

Financial Performance - Viking Therapeutics reported a net loss of $24.9 million, or $0.22 per share, for Q3 2024, compared to a net loss of $22.5 million, or $0.23 per share, in Q3 2023[19]. - For the nine months ended September 30, 2024, research and development expenses totaled $70.7 million, up from $43.3 million in the same period in 2023[20]. - The net loss for the nine months ended September 30, 2024, was $74.5 million, or $0.69 per share, compared to a net loss of $61.3 million, or $0.66 per share, in the corresponding period in 2023[21]. - Research and development expenses for Q3 2024 were $22.8 million, up from $18.4 million in Q3 2023, primarily due to increased manufacturing costs and stock-based compensation[18]. - General and administrative expenses for Q3 2024 were $13.8 million, compared to $8.9 million in Q3 2023, driven by higher stock-based compensation and legal services[18]. - As of September 30, 2024, Viking held cash, cash equivalents, and short-term investments of $930 million, significantly up from $362 million as of December 31, 2023[22]. Clinical Trials and Research - The Phase 2 VENTURE trial of VK2735 for obesity showed a maximum body weight reduction of 14.7% from baseline and 13.1% compared to placebo after 13 weeks[4]. - The Phase 2b VOYAGE trial of VK2809 in NASH/MASH demonstrated a median relative reduction in liver fat content of 38% to 55% after 12 weeks, with 85% of patients achieving at least a 30% reduction[8]. - VK2809-treated patients showed NASH/MASH resolution rates of 63% to 75% compared to 29% for placebo, and fibrosis improvement rates of 44% to 57% compared to 34% for placebo[9]. - VK0214 demonstrated significant reductions in mean plasma levels of very long-chain fatty acids and other lipids in a Phase 1b study, with mild to moderate adverse events reported[14]. - The Phase 1 trial of oral VK2735 showed dose-dependent body weight reductions of up to 5.3% from baseline, with placebo-adjusted reductions of 3.3%[6]. - Viking is developing VK2735, a dual agonist for metabolic disorders, with promising results from Phase 1 and Phase 2 trials[24]. - The company is also advancing VK2809, which successfully met primary and secondary endpoints in a Phase 2b study for non-alcoholic steatohepatitis[24]. - The dual amylin and calcitonin receptor agonist program is advancing, with preclinical data showing up to 10% weight loss in diet-induced obese mice[16]. - Upcoming scientific presentations include results from the 52-week Phase 2b VOYAGE trial of VK2809 at the 75th Liver Meeting on November 19, 2024[17]. - The company plans to initiate a Phase 2 study of oral VK2735 in obesity in Q4 2024, following positive results from a Phase 1 trial[5]. - Viking expects to hold an End-of-Phase 2 meeting with the FDA for VK2735 in Q4 2024 to discuss advancing to Phase 3[3]. - Results from the VOYAGE study will be presented at The Liver Meeting 2024, highlighting VK2809's efficacy and safety profile[12].

Conference call scheduled for 4:30 p.m. ET todayEnd-of-Phase 2 Meeting for Subcutaneous VK2735 for Obesity Planned for 4Q24Phase 2 Study of Oral VK2735 in Obesity Expected to Begin 4Q24Results of Phase 2b VOYAGE Study of VK2809 in NASH/MASH With Fibrosis Selected for Oral Presentation at AASLDPositive Phase 1b Results from VK0214 Study in X-ALD Demonstrate Safety, Tolerability and Reductions in Very Long-Chain Fatty Acids and Plasma LipidsStrong Quarter-End Cash Position of $930 MillionSAN DIEGO, Oct. 23, 2 ...

Viking Therapeutics Inc. VKTX is set to report its third-quarter earnings on Wednesday, after the market closes. The anticipation is palpable, especially as the stock has skyrocketed almost 240% year-to-date, largely due to excitement surrounding its weight-loss drug candidate, VK2735.As a new contender in the burgeoning obesity drug market, Viking is not just riding the coattails of industry giants but actively challenging them.Weight-Loss Drug ShowdownViking's VK2735 mimics both GLP-1 and GIP hormones, ai ...

Viking Therapeutics (VKTX) is set to report third-quarter earnings on Oct. 23, after market close. Since the company lacks a marketed drug in its portfolio, we do not expect it to record revenues. The Zacks Consensus Estimate for earnings is pegged at a loss of 24 cents per share.Estimates for 2024 loss per share have risen slightly from 99 cents to $1.00 in the past 60 days. Over the same timeframe, loss per share estimates for 2025 have narrowed from $1.48 to $1.46. Image Source: Zacks Investment Research ...

Shares of Viking Therapeutics (VKTX) have risen 29% in the past three months, significantly outperforming the industry's 2.5% growth. The stock has outperformed the sector and the S&P 500 during the same period. VKTX's shares are also trading above the 50-day and 200-day moving averages. VKTX Stock Outperforms Industry, Sector & S&P 500 Zacks Investment Research Image Source: This uptick in stock price was triggered by positive updates from Viking's pipeline programs. Last week, VKTX reported positive resul ...

Viking recently announced the results of an early-stage clinical trial for VK0214. Shares of pharmaceutical upstart Viking Therapeutics (VKTX 0.72%) have been soaring this year thanks to high hopes for VK2735, its promising GLP-1 weight loss treatment. Although the company doesn't have an approved product yet and isn't generating consistent revenue, the excitement around GLP-1 has been sufficient to send the stock's valuation north of $7 billion. Viking, however, is involved in more than just GLP-1 developm ...