Ventyx Biosciences Reports Third Quarter 2024 Financial Results and Highlights Recent Corporate Progress
Ventyx Biosciences (VTYX) reported Q3 2024 financial results and pipeline updates. The company maintains a strong cash position of $274.8 million, expected to fund operations into H2 2026. Net loss decreased to $35.2 million from $54.0 million in Q3 2023, while R&D expenses reduced to $30.6 million from $49.8 million.
Key pipeline developments include planned Phase 2 trials for VTX2735 in recurrent pericarditis and VTX3232 in obesity, both expected to initiate by year-end. Topline results from VTX3232's Phase 2a trial in early Parkinson's disease are anticipated in H1 2025. The company seeks partnership for tamuzimod's Phase 3 trial in ulcerative colitis.
Ventyx Biosciences (VTYX) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti sul pipeline. L'azienda mantiene una solida posizione di cassa di 274,8 milioni di dollari, prevista per finanziare le operazioni fino al secondo semestre del 2026. La perdita netta è diminuita a 35,2 milioni di dollari da 54,0 milioni nel terzo trimestre 2023, mentre le spese per R&S sono scese a 30,6 milioni di dollari da 49,8 milioni.
Sviluppi chiave del pipeline includono prove di Fase 2 pianificate per VTX2735 nella pericardite recidivante e VTX3232 nell'obesità, entrambe previste per iniziare entro la fine dell'anno. I risultati preliminari della prova di Fase 2a di VTX3232 nella malattia di Parkinson iniziale sono attesi nel primo semestre del 2025. L'azienda cerca una partnership per la prova di Fase 3 di tamuzimod nella colite ulcerosa.
Ventyx Biosciences (VTYX) ha presentado los resultados financieros del tercer trimestre de 2024 y actualizaciones del pipeline. La compañía mantiene una sólida posición de efectivo de 274,8 millones de dólares, que se espera que financie las operaciones hasta el segundo semestre de 2026. La pérdida neta se redujo a 35,2 millones de dólares desde 54,0 millones en el tercer trimestre de 2023, mientras que los gastos de I+D se redujeron a 30,6 millones de dólares desde 49,8 millones.
Los desarrollos clave del pipeline incluyen ensayos de Fase 2 planificados para VTX2735 en pericarditis recurrente y VTX3232 en obesidad, ambos previstos para comenzar a finales de año. Se anticipan resultados preliminares del ensayo de Fase 2a de VTX3232 en la enfermedad de Parkinson en etapa temprana para el primer semestre de 2025. La compañía busca una asociación para el ensayo de Fase 3 de tamuzimod en colitis ulcerosa.
벤티엑스 바이오사이언스(VTYX)는 2024년 3분기 재무 결과와 파이프라인 업데이트를 발표했습니다. 회사는 2억 7,480만 달러의 강력한 현금 보유액을 유지하고 있으며, 이는 2026년 하반기까지 운영 자금으로 사용될 예정입니다. 순손실은 2023년 3분기의 5,400만 달러에서 3,520만 달러로 감소했으며, 연구 및 개발 비용은 4,980만 달러에서 3,060만 달러로 줄었습니다.
핵심 파이프라인 개발 사항으로는 재발성 심낭염에 대한 VTX2735와 비만에 대한 VTX3232의 2상 시험이 포함되어 있으며, 두 시험 모두 연말까지 시작될 예정입니다. 초기 파킨슨병에서 VTX3232의 2a상 시험의 주요 결과는 2025년 상반기에 발표될 예정입니다. 회사는 궤양성 대장염에 대한 타무지모드의 3상 시험을 위한 파트너십을 추구하고 있습니다.
Ventyx Biosciences (VTYX) a rapporté les résultats financiers du troisième trimestre 2024 ainsi que des mises à jour sur son pipeline. L'entreprise maintient une solide position de trésorerie de 274,8 millions de dollars, qui devrait financer ses opérations jusqu'au deuxième semestre de 2026. La perte nette a diminué à 35,2 millions de dollars contre 54,0 millions lors du troisième trimestre 2023, tandis que les dépenses de R&D ont été réduites à 30,6 millions de dollars contre 49,8 millions.
Les développements clés du pipeline comprennent des essais de Phase 2 prévus pour VTX2735 dans la péricardite récurrente et VTX3232 dans l'obésité, tous deux devant commencer d'ici la fin de l'année. Les résultats préliminaires de l'essai de Phase 2a de VTX3232 dans la maladie de Parkinson précoce sont attendus au premier semestre 2025. L'entreprise recherche un partenariat pour l'essai de Phase 3 de tamuzimod dans la colite ulcéreuse.
Ventyx Biosciences (VTYX) hat die finanziellen Ergebnisse für das 3. Quartal 2024 sowie Aktualisierungen zu den Pipeline-Projekten bekannt gegeben. Das Unternehmen verfügt über eine starke Liquiditätsposition von 274,8 Millionen Dollar, die voraussichtlich die Aktivitäten bis in die zweite Hälfte 2026 finanzieren wird. Der Nettoverlust sank auf 35,2 Millionen Dollar von 54,0 Millionen im 3. Quartal 2023, während die F&E-Ausgaben auf 30,6 Millionen Dollar von 49,8 Millionen gesenkt wurden.
Wichtige Entwicklungen in der Pipeline umfassen geplante Phase-2-Studien für VTX2735 bei rezidivierender Perikarditis und VTX3232 bei Adipositas, die beide bis Ende des Jahres beginnen sollen. Die Ergebnisse der Phase-2a-Studie von VTX3232 bei früh einsetzender Parkinson-Krankheit werden für das erste Halbjahr 2025 erwartet. Das Unternehmen sucht eine Partnerschaft für die Phase-3-Studie zu Tamuzimod bei Colitis ulcerosa.
- Strong cash position of $274.8M sufficient until H2 2026
- Reduced net loss by 35% YoY to $35.2M
- R&D expenses decreased by 39% YoY to $30.6M
- Positive Phase 1 results for VTX3232 showing dose-dependent efficacy
- VTX958 failed to meet primary endpoint in Crohn's disease Phase 2 trial
- Seeking external funding/partnership for tamuzimod Phase 3 trial indicates potential financial constraints
- Halting internal resource allocation to VTX958 development
Insights
The Q3 results reveal a significant improvement in financial efficiency.
The pipeline strategy shift, particularly stepping back from VTX958 development and seeking partnership for tamuzimod, suggests prudent capital management. The company's focus on NLRP3 inhibitors (VTX3232 and VTX2735) with multiple Phase 2 trials starting by year-end represents a strategic pivot toward potentially more promising therapeutic areas.
However, investors should note that with multiple Phase 2 trials upcoming, cash burn could accelerate in 2025, though current reserves appear adequate for planned operations.
The strategic focus on NLRP3 inhibitors is particularly noteworthy. VTX3232's dual development path in Parkinson's and obesity/cardiometabolic conditions represents an innovative approach to targeting inflammation-driven diseases. The Phase 1 data showing CNS penetration and IL-1β inhibition supports its potential as a best-in-class candidate.
The decision to advance VTX2735 into recurrent pericarditis is well-supported by positive CAPS trial results, potentially addressing an unmet need in autoinflammatory diseases. The shift away from VTX958 in Crohn's disease, despite showing some biomarker improvements, reflects a pragmatic approach to pipeline prioritization.
Topline results from the Phase 2a trial of VTX3232 in patients with early Parkinson’s disease expected in H1 2025
Phase 2 trial of VTX3232 in subjects with obesity and cardiometabolic risk factors expected to initiate by year-end, with topline results anticipated in H2 2025
Phase 2 trial of VTX2735 in patients with recurrent pericarditis expected to initiate by year-end, with topline results anticipated in H2 2025
Cash balance of
SAN DIEGO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent pipeline and business progress.
“Thanks to the continued execution of our team, we are on track to initiate a Phase 2 trial of VTX2735 in recurrent pericarditis and a Phase 2 obesity and cardiometabolic trial of VTX3232 by the end of this year, in addition to advancing enrollment in the ongoing Phase 2a trial of VTX3232 in patients with early Parkinson’s disease,” said Raju Mohan, PhD, President and Chief Executive Officer. “With our potential best-in-class NLRP3 inhibitors, we believe we are well positioned to unlock the vast therapeutic potential of the inflammasome pathway.”
Pipeline Updates
NLRP3 Portfolio
- VTX3232 (CNS-penetrant NLRP3 Inhibitor): We initiated a Phase 2a trial of VTX3232 in participants with early Parkinson’s disease during the third quarter of 2024, with the primary goal of evaluating safety and key inflammatory biomarkers in the plasma and cerebrospinal fluid (CSF). The trial also includes an exploratory endpoint of PET-tracer imaging as an assessment of microglial activation. We also expect to initiate a 12-week Phase 2 trial of VTX3232 in participants with obesity and additional cardiovascular and cardiometabolic risk factors by year-end. This trial will evaluate the effect of VTX3232 on key inflammatory and cardiometabolic biomarkers as well as on weight change, when dosed as a monotherapy and in combination with a GLP-1 receptor agonist.
These Phase 2 trials follow positive topline results from the Phase 1 single- and multiple-ascending dose (SAD, MAD) trial of VTX3232 in adult healthy volunteers. In the Phase 1 trial, VTX3232 exhibited a dose-dependent and dose-linear pharmacokinetic profile with repeat once-daily doses of VTX3232 exceeding steady-state IL-1β IC90 coverage in both plasma and CSF. We believe these data support the potential for VTX3232 as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory and cardiometabolic diseases.
- VTX2735 (Peripheral NLRP3 Inhibitor): We expect to initiate a Phase 2 trial of VTX2735 in participants with recurrent pericarditis by year-end, with the goal of evaluating safety and the effect of VTX2735 on disease-relevant biomarkers and pain scores. We believe that by treating and preventing disease recurrence, VTX2735 has the potential to become the first approved oral therapy for recurrent pericarditis, a debilitating autoinflammatory disease associated with activation of the NLRP3 inflammasome.
We previously announced data from a Phase 2 trial of VTX2735 in participants with cryopyrin-associated periodic syndromes (CAPS), a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. These proof-of-concept data demonstrated the therapeutic benefit of targeting NLRP3 in humans with evidence of strong efficacy and a favorable safety profile. We believe these results support the therapeutic potential of VTX2735 in recurrent pericarditis and numerous additional chronic peripheral inflammatory diseases.
IBD Portfolio
- Tamuzimod (formerly VTX002, S1P1R Modulator): We recently presented new long-term extension (LTE) data from the tamuzimod Phase 2 trial in patients with ulcerative colitis at the United European Gastroenterology (UEG) Week meeting in Vienna, Austria. These 52-week data continue to reinforce the potential best-in-class profile of tamuzimod in ulcerative colitis (UC) including a potential best-in-disease safety profile amongst all the oral options for UC therapy. We believe the high rates of clinical remission and endoscopic remission position tamuzimod as the backbone of future combination therapies. We intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of tamuzimod in UC.
- VTX958 (TYK2 Inhibitor): As previously announced, VTX958 did not meet the primary endpoint of change from baseline in CDAI (symptomatic outcome) in a Phase 2 trial in patients with Crohn’s disease, due to abnormally high placebo response. VTX958 did demonstrate robust, dose-dependent, nominally statistically significant endoscopic response rates at Week 12, as measured by SES-CD (an objective endpoint), and showed a greater magnitude of decrease compared to placebo in two key biomarkers of inflammation, C-reactive protein and fecal calprotectin. Recognizing the opportunity for a safe and effective oral TYK2 inhibitor as early-line therapy in Crohn’s disease, we are continuing the analysis of the Phase 2 data including data from the 52-week treat-through long-term extension phase to better understand the path forward for VTX958. At this time, we do not plan to commit significant internal resources to further development of VTX958.
Third Quarter 2024 Financial Results:
- Cash Position: Cash, cash equivalents and marketable securities were
$274.8 million as of September 30, 2024. We believe our current cash, cash equivalents and marketable securities are sufficient to fund our planned operations into at least the second half of 2026. - Research and Development (R&D) expenses: R&D expenses were
$30.6 million for the third quarter of 2024, compared to$49.8 million for the third quarter of 2023. - General and Administrative (G&A) expenses: G&A expenses were
$7.9 million for the third quarter of 2024, compared to$8.2 million for the third quarter of 2023. - Net loss: Net loss was
$35.2 million for the third quarter of 2024, compared to$54.0 million for the third quarter of 2023.
About Ventyx Biosciences
Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com.
Forward-Looking Statements
Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates, including the potential of VTX3232 and VTX2735, to emerge as a best-in-class NLRP3 inhibitor for the treatment of inflammatory, neuroinflammatory and cardiometabolic diseases and conditions, the potential of tamuzimod as a best-in-disease oral agent in Ulcerative Colitis (UC) and best-in-disease safety profile, and the potential of VTX2735 to be the first approved oral therapy for recurrent pericarditis and to have therapeutic potential in additional chronic peripheral inflammatory diseases; the design of clinical studies to be conducted by the Company; the anticipated timing for the initiation of a Phase 2 trial of VTX3232 subjects with obesity and cardiometabolic risk factors by year-end 2024, and the initiation of a Phase 2 trial of VTX2735 in recurrent pericarditis by year-end 2024; the timing of clinical updates for all three Phase 2 studies of VTX3232 and VTX2735, including the publication of any clinical data from these studies in 2025; the continued analysis of the Phase 2 data from the study of VTX958 in subjects with Crohn’s disease; management’s plans with respect to a potential pivotal Phase 3 trial for tamuzimod in UC, supported by a partner or other source of non-dilutive financing; management’s plans with respect to the commitment of internal resources toward development of VTX958; and the expected timeframe for funding Ventyx’s operating plan with current cash, cash equivalents and marketable securities.
The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed on or about November 7, 2024, and Ventyx’s subsequent filings with the SEC.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact
Joyce Allaire
Managing Director
LifeSci Advisors
IR@ventyxbio.com
| Ventyx Biosciences, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 30,629 | $ | 49,750 | $ | 92,181 | $ | 133,747 | ||||||||
| General and administrative | 7,923 | 8,201 | 23,851 | 23,901 | ||||||||||||
| Total operating expenses | 38,552 | 57,951 | 116,032 | 157,648 | ||||||||||||
| Loss from operations | (38,552 | ) | (57,951 | ) | (116,032 | ) | (157,648 | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest income | (3,350 | ) | (3,932 | ) | (10,360 | ) | (11,453 | ) | ||||||||
| Other expense | 47 | 8 | 99 | 14 | ||||||||||||
| Total other (income) expense | (3,303 | ) | (3,924 | ) | (10,261 | ) | (11,439 | ) | ||||||||
| Net loss | $ | (35,249 | ) | $ | (54,027 | ) | $ | (105,771 | ) | $ | (146,209 | ) | ||||
| Unrealized gain on marketable securities | 922 | 192 | 741 | 544 | ||||||||||||
| Foreign currency translation | 199 | 11 | 182 | 72 | ||||||||||||
| Comprehensive loss | $ | (34,128 | ) | $ | (53,824 | ) | $ | (104,848 | ) | $ | (145,593 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.50 | ) | $ | (0.92 | ) | $ | (1.56 | ) | $ | (2.51 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 70,667,570 | 58,880,427 | 67,694,970 | 58,363,174 | ||||||||||||
| Ventyx Biosciences, Inc. | ||||||||
| Selected Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 274,825 | $ | 252,220 | ||||
| Working capital | 277,105 | 242,080 | ||||||
| Total assets | 301,100 | 277,693 | ||||||
| Total liabilities | 22,328 | 33,770 | ||||||
| Accumulated deficit | (524,958 | ) | (419,187 | ) | ||||
| Total stockholders' equity | 278,772 | 243,923 | ||||||
FAQ
What were Ventyx Biosciences (VTYX) Q3 2024 financial results?
When will VTYX report topline results for VTX3232 in Parkinson's disease?
What happened with VTYX's VTX958 drug trial?
