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Viking Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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Viking Therapeutics (NASDAQ: VKTX) reported Q2 2024 financial results and provided corporate updates.

Key points include:

  • VK2735: Advancing to Phase 3 for obesity after successful Phase 2 outcomes; Phase 2 oral study to begin in Q4 2024.
  • VK2809: Positive biopsy results in NASH/MASH; End-of-Phase 2 meeting planned for Q4 2024.
  • VK0214: Phase 1b study completed enrollment for X-ALD; data expected in H2 2024.
  • Financials: Net loss of $22.3M ($0.20 per share) in Q2 2024 versus $19.2M ($0.19 per share) in Q2 2023. Cash and equivalents at $942M as of June 30, 2024.

Viking will host a conference call at 4:30 p.m. ET today to discuss these results.

Viking Therapeutics (NASDAQ: VKTX) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito aggiornamenti aziendali.

I punti chiave includono:

  • VK2735: Passaggio alla Fase 3 per l'obesità dopo risultati positivi nella Fase 2; studio orale di Fase 2 in programma per il quarto trimestre del 2024.
  • VK2809: Risultati di biopsia positivi in NASH/MASH; incontro di fine Fase 2 programmato per il quarto trimestre del 2024.
  • VK0214: Studio di Fase 1b con reclutamento completato per X-ALD; dati attesi nella seconda metà del 2024.
  • Finanze: Perdita netta di 22,3 milioni di dollari (0,20 dollari per azione) nel secondo trimestre del 2024 rispetto a una perdita di 19,2 milioni di dollari (0,19 dollari per azione) nel secondo trimestre del 2023. Disponibilità liquide e equivalenti pari a 942 milioni di dollari al 30 giugno 2024.

Viking ospiterà una call conferenza oggi alle 16:30 ET per discutere questi risultati.

Viking Therapeutics (NASDAQ: VKTX) informó sobre los resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones corporativas.

Los puntos clave incluyen:

  • VK2735: Avanzando a Fase 3 para la obesidad tras resultados exitosos en Fase 2; estudio oral de Fase 2 comenzará en el cuarto trimestre de 2024.
  • VK2809: Resultados de biopsia positivos en NASH/MASH; reunión de fin de Fase 2 planificada para el cuarto trimestre de 2024.
  • VK0214: Estudio de Fase 1b completó el reclutamiento para X-ALD; se esperan datos en la segunda mitad de 2024.
  • Financieros: Pérdida neta de $22.3M ($0.20 por acción) en el segundo trimestre de 2024 en comparación con una pérdida de $19.2M ($0.19 por acción) en el segundo trimestre de 2023. Efectivo y equivalentes de $942M al 30 de junio de 2024.

Viking realizará una llamada de conferencia hoy a las 4:30 p.m. ET para discutir estos resultados.

Viking Therapeutics (NASDAQ: VKTX)는 2024년 2분기 재무 결과를 보고하고 회사 업데이트를 제공했습니다.

주요 내용은 다음과 같습니다:

  • VK2735: 2상 결과 성공 후 비만에 대한 3상으로 진행; 2024년 4분기에 2상 경구 연구 시작 예정.
  • VK2809: NASH/MASH에서 긍정적인 생검 결과; 2024년 4분기에 2상 종료 회의 계획.
  • VK0214: X-ALD에 대한 1b상 연구 참여율 완료; 2024년 하반기에 데이터 예상.
  • 재무: 2024년 2분기에 2,230만 달러(주당 0.20달러)의 순손실 발생, 2023년 2분기에는 1,920만 달러(주당 0.19달러)의 순손실 발생. 2024년 6월 30일 기준 현금 및 현금성 자산 9억 4,200만 달러.

Viking은 오늘 오후 4시 30분(ET)에 이 결과에 대해 논의하는 컨퍼런스 콜을 개최합니다.

Viking Therapeutics (NASDAQ: VKTX) a publié les résultats financiers du deuxième trimestre 2024 et a fourni des mises à jour sur l'entreprise.

Les points clés incluent :

  • VK2735: Avancement vers la phase 3 pour l'obésité après des résultats positifs en phase 2; étude orale de phase 2 qui débutera au quatrième trimestre 2024.
  • VK2809: Résultats de biopsie positifs dans le NASH/MASH; réunion de fin de phase 2 prévue pour le quatrième trimestre 2024.
  • VK0214: Étude de phase 1b avec recrutement terminé pour X-ALD; données attendues dans la seconde moitié de 2024.
  • Finances : Perte nette de 22,3 millions de dollars (0,20 $ par action) au deuxième trimestre 2024 contre 19,2 millions de dollars (0,19 $ par action) au deuxième trimestre 2023. Trésorerie et équivalents s'élevant à 942 millions de dollars au 30 juin 2024.

Viking organisera une conférence téléphonique aujourd'hui à 16h30 ET pour discuter de ces résultats.

Viking Therapeutics (NASDAQ: VKTX) hat die finanziellen Ergebnisse des 2. Quartals 2024 veröffentlicht und Unternehmensupdates bereitgestellt.

Wesentliche Punkte sind:

  • VK2735: Fortschritt in die Phase 3 für Fettleibigkeit nach erfolgreichen Phase-2-Ergebnissen; Phase-2-Studie zu oralen Anwendungen beginnt im 4. Quartal 2024.
  • VK2809: Positive Biopsieergebnisse bei NASH/MASH; Treffen am Ende der Phase 2 ist für das 4. Quartal 2024 geplant.
  • VK0214: Phase-1b-Studie hat die Rekrutierung für X-ALD abgeschlossen; Ergebnisse werden für die zweite Hälfte von 2024 erwartet.
  • Finanzen: Nettverlust von 22,3 Millionen USD (0,20 USD pro Aktie) im 2. Quartal 2024 im Vergleich zu einem Verlust von 19,2 Millionen USD (0,19 USD pro Aktie) im 2. Quartal 2023. Bargeld und Äquivalente betragen zum 30. Juni 2024 942 Millionen USD.

Viking wird heute um 16:30 Uhr ET eine Telefonkonferenz abhalten, um diese Ergebnisse zu diskutieren.

Positive
  • VK2735 advancing to Phase 3 for obesity treatment.
  • Positive biopsy results for VK2809 in NASH/MASH.
  • Completion of VK0214 Phase 1b enrollment for X-ALD.
  • Strong financial position with $942M in cash and equivalents.
Negative
  • Net loss increased to $22.3M in Q2 2024 from $19.2M in Q2 2023.

Viking Therapeutics' Q2 2024 results and pipeline updates demonstrate significant progress, but also increased expenses as the company advances its clinical programs. Key financial points:

  • R&D expenses increased to $23.8 million in Q2 2024 from $13.9 million in Q2 2023, reflecting higher costs for manufacturing, clinical trials and personnel.
  • Net loss widened to $22.3 million ($0.20 per share) compared to $19.2 million ($0.19 per share) in Q2 2023.
  • Cash position remains strong at $942 million as of June 30, 2024, up from $362 million at the end of 2023, likely due to a successful capital raise.

The robust cash position provides Viking with a substantial runway to fund its maturing pipeline, particularly the advancement of VK2735 into Phase 3 for obesity. However, investors should note the accelerating cash burn as programs progress. The company's focus on metabolic disorders, especially obesity, positions it in a high-growth market with significant potential. The positive clinical data from multiple programs, particularly VK2735 and VK2809, could drive significant value if successfully commercialized.

Viking's pipeline is showing impressive clinical progress across multiple programs:

  • VK2735 for obesity: Phase 2 VENTURE study showed up to 14.7% weight loss at 13 weeks, with a favorable safety profile. Advancing to Phase 3 is a significant milestone.
  • Oral VK2735: Phase 1 data showed up to 5.3% weight loss after just 28 days, with good tolerability. This could be a game-changer if efficacy is maintained in longer studies.
  • VK2809 for NASH: Phase 2b VOYAGE study met primary and secondary endpoints, with 63-75% of patients achieving NASH resolution and 44-57% showing fibrosis improvement.
  • VK0214 for X-ALD: Phase 1b study fully enrolled, with results expected in 2H 2024.

The obesity market is highly competitive, but VK2735's efficacy appears competitive with other GLP-1/GIP dual agonists. The oral formulation could be a significant differentiator. In NASH, VK2809's efficacy and safety profile look promising, potentially offering advantages over competitors. The diversified pipeline across obesity, NASH and rare diseases like X-ALD provides multiple shots on goal and risk mitigation.

Viking Therapeutics is positioning itself as a major player in the rapidly growing obesity and NASH markets:

  • The global obesity market is projected to reach $54 billion by 2030, driven by increasing prevalence and new pharmacological options.
  • NASH market potential is estimated at $20-35 billion by 2025, with no FDA-approved treatments currently available.

Viking's VK2735 for obesity shows competitive efficacy compared to approved GLP-1 agonists, with potential advantages in an oral formulation. The NASH candidate VK2809 demonstrates promising efficacy and safety, potentially addressing a significant unmet need. The company's focus on metabolic disorders aligns with growing market demand and increasing healthcare priorities.

Investor interest in the obesity space has surged following the success of Novo Nordisk's Wegovy and Eli Lilly's Mounjaro. Viking's progress could attract partnership or acquisition interest from larger pharmaceutical companies looking to expand in this area. The company's strong cash position and advancing pipeline make it an attractive player in a hot therapeutic area.

Conference call scheduled for 4:30 p.m. ET today

  • VK2735 to Advance to Phase 3 for Obesity; End-of-Phase 2 Meeting Planned for 2H24

  • Oral VK2735 Phase 2 Study in Obesity Expected to Begin 4Q24

  • Positive Biopsy Results From VK2809 Reported in June; End-of-Phase 2 Meeting in NASH/MASH Planned for 4Q24

  • Enrollment Completed in Phase 1b Study of VK0214 for X-ALD; Data Expected 2H24

  • In Vivo Data From Novel Amylin Agonist Program Reported at ADA in June; IND in Obesity Planned for 2025

SAN DIEGO, July 24, 2024 /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 second quarter and six months ended June 30, 2024, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter Ended June 30, 2024, and Other Recent Events:

"The first half of 2024 was marked by strong momentum in the company's pipeline programs, as we reported successful outcomes from three different clinical trials, and began preparing for next steps with each program," stated Brian Lian, Ph.D., chief executive officer of Viking.  "The Phase 2 VENTURE study of VK2735 in obesity demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing, as well as promising safety and tolerability.  Following receipt of written feedback from an FDA Type C meeting, we are advancing this compound into Phase 3 development.  We are currently preparing for an end of Phase 2 meeting with the agency, which we expect to occur later this year.  Separately, the Phase 1 study of the oral tablet formulation of VK2735 demonstrated encouraging safety and tolerability, and positive signs of clinical activity, with subjects reporting mean weight loss of up to 5.3% from baseline following 28 days of daily oral dosing.  Dose escalation continues, and we expect to initiate a Phase 2 trial for this program later this year.  

"We also recently reported best-in-class histology data from the Phase 2b VOYAGE study of our thyroid hormone beta receptor agonist VK2809 in biopsy-confirmed NASH and fibrosis, and plan to schedule an end of Phase 2 meeting with the FDA later this year.  With our earlier-stage programs, we are happy to report that the Phase 1b study of our second thyroid hormone beta receptor agonist VK0214, for X-linked adrenoleukodystrophy, is fully enrolled and we expect to report the results from this trial later this year.  Finally, at the ADA conference in June, we reported promising in vivo data from a novel series of internally developed amylin agonists and expect to file an IND for this program in 2025.  To support Viking's maturing pipeline, the company ended the quarter with a strong balance sheet of $942 million, providing the runway to execute key milestones for each of our pipeline programs."

Pipeline and Recent Corporate Highlights

  • Reported Positive Clinical Results from Phase 2 VENTURE Study of Subcutaneous VK2735 for Obesity in 1H24; To Advance into Phase 3 Development. VK2735 is a wholly owned 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.

    During the first quarter of 2024, Viking announced positive top-line results from a Phase 2 study called VENTURE. This study was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly, for 13 weeks. The trial was designed to enroll adults who are obese (BMI ≥30 kg/m2) or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition.  The VENTURE trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo.  Additionally, the study showed VK2735 to be safe and well tolerated, with the majority of treatment emergent adverse events (TEAEs) being categorized as mild or moderate.

    With respect to the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%, as well as statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all doses starting at Week 1 and were maintained throughout the course of the study. Weight loss in all treated cohorts appeared to be progressive through 13 weeks and did not show evidence of plateauing. The company believes further weight loss could be achieved through extended dosing beyond the 13-week treatment period of this study.

    VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events (AEs) being reported as mild or moderate. Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo. Of gastrointestinal (GI) related AEs, 95% were reported as mild or moderate. Across all cohorts in the VENTURE study, GI-related AEs were most prevalent during the first week of the study, with observed rates generally declining through the remainder of the study.

    During the second quarter, Viking received written responses to a U.S. Food and Drug Administration (FDA) Type C meeting packet, submitted to the agency earlier in the quarter.  Based on agency feedback, the company plans to advance VK2735 into a Phase 3 program for obesity.  Viking expects to schedule an end-of-Phase 2 meeting with the FDA later this year.  Details on Phase 3 trial design and timing will be disclosed following the end-of-Phase 2 meeting.

  • Reported Positive Clinical Results from Phase 1 Study Evaluating Oral VK2735 for Obesity in 1H24; Expect to Initiate Oral Phase 2 Trial in 4Q24.  In parallel with the development of a sub-cutaneous formulation of VK2735, Viking is also developing an oral tablet formulation of this compound.  The company believes a tablet formulation could represent an attractive treatment option for patients who are hesitant to initiate injection-based therapy, or for those seeking to maintain the weight loss they have already achieved.  A key advantage in this regard is the potential to transition patients from the subcutaneous formulation to an oral formulation which utilizes the same molecule.  Viking believes this may reduce the risk of unexpected safety or tolerability challenges, and could be an attractive option for both patients and clinicians.

    During the first quarter, Viking reported the initial data from a randomized, double-blind, placebo-controlled Phase 1 trial in healthy adults with a minimum BMI of 30 kg/m2, evaluating once-daily oral doses ranging from 2.5 mg to 40 mg.  The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as an oral tablet once daily for 28 days. The secondary objective was to evaluate the pharmacokinetics of orally administered VK2735 in healthy subjects. Exploratory pharmacodynamic measures included assessments of changes in body weight and other metrics.

    With respect to safety and tolerability, oral VK2735 was shown to be safe and well tolerated following once daily dosing for up to 28 days, at dose levels up to 40 mg. Among subjects receiving oral VK2735, all TEAEs were reported as mild or moderate in severity, with the majority, 76%, reported as mild. Similarly, all GI-related AEs in this study were reported as mild or moderate, with the majority, 79%, reported as mild. Mild nausea was reported in 14% of subjects receiving VK2735. No vomiting was reported among subjects receiving VK2735. Diarrhea was reported in 3% of VK2735 treated subjects, compared with 20% of subjects receiving placebo. Overall, no clinically meaningful differences were reported for GI AEs among subjects treated with VK2735 compared with placebo.

    An exploratory assessment of change in body weight showed that subjects receiving oral VK2735 demonstrated dose dependent reductions in body weight, ranging up to 5.3% from baseline. Placebo-adjusted reductions in body weight reached up to 3.3% from baseline. Body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated. Weight loss in the 28-day window of this study was progressive at the 20 mg and 40 mg dose levels, with no plateau observed.

    Given the promising weight loss signal demonstrated after 28 days of once daily, along with the excellent tolerability profile observed thus far, further dose-escalation has been evaluated at daily doses of up to 80 mg; dosing at 100 mg is ongoing.  Results from these cohorts will be reported later this year.  Viking believes that further benefits from oral dosing of VK2735 might be anticipated from longer dosing periods.  To this end, the company plans to initiate a 13 week Phase 2 trial in patients with obesity in the fourth quarter of this year.

  • Reported Positive 52-Week Histologic Data from Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH and Fibrosis in 2Q24; Primary and Secondary Endpoints Successfully Achieved for Both NASH and Fibrosis with Excellent Safety and Tolerability. VK2809 is an orally available, small molecule agonist of the thyroid hormone receptor that is selective for liver tissue, as well as the beta isoform of the receptor.

    In the first quarter, Viking announced completion of the Phase 2b VOYAGE study evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis.  This study was a randomized, double-blind, placebo-controlled, multicenter, international trial designed to assess the efficacy, safety and tolerability of VK2809 following 52 weeks of dosing in patients with biopsy-confirmed NASH and fibrosis.  Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging, proton density fat fraction, as well as F2 and F3 fibrosis. The primary endpoint of the study evaluated the change in liver fat from baseline to Week 12 in patients treated with VK2809 compared to patients receiving placebo. Secondary and exploratory endpoints assessed histologic changes, such as NASH resolution and fibrosis improvement, following 52 weeks of treatment.

    In 2023, the company reported that VOYAGE had successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo.  The median relative change from baseline in liver fat among patients treated with VK2809 ranged from 38% to 55% after 12 weeks.  In addition, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat.

    In the second quarter of 2024, Viking announced additional results from the VOYAGE study, demonstrating the successful achievement of the trial's secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment.  On the secondary endpoint of NASH resolution without worsening of fibrosis, VK2809-treated patients demonstrated NASH resolution rates ranging from 63% to 75%, compared with 29% for placebo.  On the secondary endpoint evaluating the proportion of patients demonstrating at least a one stage improvement in fibrosis with no worsening of NASH, the proportion of VK2809-treated patients demonstrating improvements in fibrosis ranged from 44% to 57%, compared with 34% for placebo. On the secondary endpoint evaluating the proportion of patients experiencing both the resolution of NASH and at least a one-stage improvement in fibrosis, the proportion of VK2809-treated patients achieving both measures ranged from 40% to 50%, compared with 20% for placebo.

    Consistent with prior studies, patients receiving VK2809 in VOYAGE demonstrated statistically significant improvements in plasma lipids.  Placebo-adjusted reductions in LDL-C ranged from 20% to 25%, and reductions in triglycerides and atherogenic proteins such as apolipoprotein B, lipoprotein (a), and apolipoprotein C-III, were significantly improved relative to placebo.  These lipids have been correlated with cardiovascular risk, suggesting that that treatment with VK2809 may offer a long-term cardio-protective benefit.

    VK2809 also demonstrated an encouraging safety and tolerability profile through 52 weeks of treatment, with minimal differences compared with the previously reported results from 12 weeks.  The majority, 94%, of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate.  Discontinuations due to adverse events were low and balanced across placebo and treatment arms.  VK2809 demonstrated excellent gastrointestinal tolerability through 52 weeks of treatment, with similar rates of nausea, diarrhea, stool frequency, and vomiting among VK2809-treated patients as compared to placebo.

    The company believes the Phase 2b VOYAGE data demonstrate VK2809's best-in-class efficacy on both NASH resolution and fibrosis improvement, along with the potential for cardiovascular benefit through improvement in plasma lipids.  Viking plans to schedule an end of Phase 2 meeting with the FDA in the fourth quarter of 2024.

  • Enrollment Complete for Phase 1b Study of VK0214 in X-ALD: Results Expected 2H24. VK0214 is a novel, orally available thyroid hormone receptor beta agonist that is being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a rare neurogenerative disease for which there are currently no pharmacologic treatment options.

    The Phase 1b study of VK0214 is enrolling patients with the adrenomyeloneuropathy, or AMN, form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled multi-center study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered orally, once daily for 28 days. The study also includes an evaluation of the pharmacokinetics of VK0214 in AMN patients, as well as an exploratory assessment of changes in plasma levels of very long chain fatty acids.

    Enrollment in the Phase 1b study of VK0214 in adrenomyeloneuropathy was recently completed and the company expects to announce results in the second half of 2024.

  • Presented Positive Preclinical Data from New, Internally Developed Dual Amylin and Calcitonin Receptor Agonist (DACRA) Program at 84th Scientific Sessions of the American Diabetes Association; Viking DACRAs Demonstrated Significant Weight Loss in Animal Models.  During the second quarter, Viking presented preclinical data at the American Diabetes Association's (ADA's) scientific sessions from an internally developed dual amylin and calcitonin receptor agonist program.  As the amylin receptor plays an important role in food intake and metabolic control, Viking believes it represents an attractive potential target for therapeutic intervention in obesity.

    The company's ADA presentation highlighted the effects of treatment on body weight, food intake and metabolic profile in both healthy rats and in diet-induced obese mice. The study demonstrated that Viking's dual amylin and calcitonin receptor agonists reduced food intake in lean rats in the period from 0 – 72 hours following a single subcutaneous dosing.  At 72 hours following a single dose, Viking's compounds resulted in up to 8% body weight reductions compared to vehicle-treated animals.  In a rodent model of diet-induced obesity, treatment with Viking's compounds for 24 days resulted in up to 10% weight loss from baseline.

    The company is encouraged by these initial findings and believes that these results, as well as those from other preclinical studies, support the continued development of amylin agonists for obesity. Viking expects to file an IND for this program in 2025.

  • Upcoming Investor Events.  Viking management will participate in the following upcoming investor events:

BTIG Biotechnology Conference
Virtual
August 5 - 6

Morgan Stanley 22nd Annual Global Healthcare Conference
New York, NY
September 4 - 6

Second Quarter and Six Month 2024 Financial Highlights

Second Quarter ended June 30, 2024 and 2023

Research and development expenses were $23.8 million for the three months ended June 30, 2024, compared to $13.9 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates, clinical studies, pre-clinical studies, salaries and benefits and stock-based compensation.

General and administrative expenses were $10.3 million for the three months ended June 30, 2024, compared to $9.8 million for the same period in 2023.  The increase 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.

For the three months ended June 30, 2024, Viking reported a net loss of $22.3 million, or $0.20 per share, compared to a net loss of $19.2 million, or $0.19 per share, in the corresponding period in 2023.  The increase in net loss for the three months ended June 30, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously, partially offset by increased interest income, compared to the same period in 2023.

Six Months Ended June 30, 2024 and 2023

Research and development expenses for the six months ended June 30, 2024 were $47.9 million compared to $24.9 million for the same period in 2023. The increase 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.

General and administrative expenses for the six months ended June 30, 2024 were $20.3 million compared to $19.4 million for the same period in 2023. The increase 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.

For the six months ended June 30, 2024, Viking reported a net loss of $49.6 million, or $0.46 per share, compared to a net loss of $38.8 million, or $0.44 per share, in the corresponding period in 2023. The increase in net loss for the six months ended June 30, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously, partially offset by increased interest income, compared to the same period in 2023.

Balance Sheet as of June 30, 2024

At June 30, 2024, Viking held cash, cash equivalents and short-term investments of $942 million, compared to $362 million as of December 31, 2023. 

Conference Call

Management will host a conference call to discuss Viking's second quarter 2024 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 July 31, 2024, by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 4777459.  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, with three compounds currently in clinical trials. 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. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders 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 a Phase 1 trial. 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 recently completed 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). VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD.

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 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, 2023, 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.

Consolidated Statements of Operations and Comprehensive Loss


(In thousands, except per share amounts)

(Unaudited)




Three Months Ended  
June 30,



Six Months Ended
June 30,




2024



2023



2024



2023


Revenues


$



$



$



$


Operating expenses:













Research and development



23,769




13,917




47,872




24,925


General and administrative



10,285




9,823




20,255




19,352


Total operating expenses



34,054




23,740




68,127




44,277


Loss from operations



(34,054)




(23,740)




(68,127)




(44,277)


Other income (expense):













Amortization of financing costs



(18)




(32)




(46)




(60)


Interest income, net



11,820




4,547




18,565




5,581


Realized gain on investments, net



2







2





Total other income, net



11,804




4,515




18,521




5,521


Net loss



(22,250)




(19,225)




(49,606)




(38,756)


Other comprehensive loss, net of tax:













Unrealized gain (loss) on securities



(699)




(417)




(1,824)




84


Foreign currency translation gain (loss)



26




(5)




(59)




(22)


Comprehensive loss


$

(22,923)



$

(19,647)



$

(51,489)



$

(38,694)


Basic and diluted net loss per share


$

(0.20)



$

(0.19)



$

(0.46)



$

(0.44)


Weighted-average shares used to compute basic
 and diluted net loss per share



110,390




99,010




106,924




88,738


 

Viking Therapeutics, Inc.

Consolidated Balance Sheets


(In thousands, except share and per share amounts)




June 30,
2024



December 31,
2023




(Unaudited)





Assets







Current assets:







Cash and cash equivalents


$

43,915



$

55,516


Short-term investments – available-for-sale



898,348




306,563


Prepaid clinical trial and preclinical study costs



3,323




2,624


Prepaid expenses and other current assets



138




2,522


Total current assets



945,724




367,225


Right-of-use assets



977




1,126


Deferred financing costs



105




106


Deposits



33




33


Total assets


$

946,839



$

368,490


Liabilities and stockholders' equity







Current liabilities:







Accounts payable


$

11,090



$

7,512


Other accrued liabilities



13,669




11,299


Lease liability, current



334




324


Total current liabilities



25,093




19,135


Lease liability, net of current portion



766




936


Total long-term liabilities



766




936


Total liabilities



25,859




20,071


Commitments and contingencies







Stockholders' equity:







Preferred stock, $0.00001 par value: 10,000,000 shares
authorized at June 30, 2024 and December 31, 2023; no
shares issued and outstanding at June 30, 2024 and
December 31, 2023







Common stock, $0.00001 par value: 300,000,000 shares
authorized at June 30, 2024 and December 31, 2023;
110,796,200 shares issued and outstanding at June 30,
2024 and 100,113,770 shares issued and outstanding at December 31, 2023



1




1


Treasury stock at cost, no shares at June 30, 2024 and 2,193,251 shares at
December 31, 2023






(6,795)


Additional paid-in capital



1,350,801




733,546


Accumulated deficit



(427,550)




(377,944)


Accumulated other comprehensive loss



(2,272)




(389)


Total stockholders' equity



920,980




348,419


Total liabilities and stockholders' equity


$

946,839



$

368,490


 

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SOURCE Viking Therapeutics, Inc.

FAQ

What is the next step for Viking Therapeutics' VK2735 after Phase 2?

VK2735 will advance to Phase 3 for obesity, with an end-of-Phase 2 meeting planned for the second half of 2024.

When will the oral Phase 2 study for VK2735 begin?

The oral Phase 2 study for VK2735 in obesity is expected to begin in the fourth quarter of 2024.

What were the financial results of Viking Therapeutics for the second quarter of 2024?

Viking reported a net loss of $22.3 million, or $0.20 per share, for Q2 2024.

How much cash does Viking Therapeutics have as of June 30, 2024?

As of June 30, 2024, Viking Therapeutics had $942 million in cash, cash equivalents, and short-term investments.

What are the latest developments for VK2809 in NASH/MASH treatment?

VK2809 reported positive biopsy results in NASH/MASH and plans to schedule an end-of-Phase 2 meeting with the FDA in Q4 2024.

Viking Therapeutics, Inc

NASDAQ:VKTX

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5.77B
110.80M
6.08%
75.22%
15.22%
Biotechnology
Pharmaceutical Preparations
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United States of America
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