Ventyx Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Corporate Progress

Rhea-AI Summary

Ventyx Biosciences (VTYX) reported its Q4 and full year 2024 financial results, highlighting multiple upcoming Phase 2 data readouts in 2025. The company maintains a strong financial position with $252.9 million in cash and equivalents, expected to fund operations into H2 2026.

Key pipeline updates include:

• VTX2735 Phase 2 trial in recurrent pericarditis results expected in H2 2025
• VTX3232 Phase 2 trial in obesity and cardiometabolic risk factors data expected in H2 2025
• VTX3232 biomarker study in early Parkinson's disease completion expected in Q2 2025

Financial highlights for 2024:

• R&D expenses decreased to $117.0M from $175.8M in 2023
• G&A expenses slightly decreased to $31.4M from $32.2M in 2023
• Net loss improved to $135.1M compared to $193.0M in 2023

Positive

• Cash position of $252.9M sufficient to fund operations into H2 2026
• R&D expenses reduced by 33.4% YoY to $117.0M
• Net loss improved by 30% YoY to $135.1M
• Multiple Phase 2 trial readouts expected throughout 2025

Negative

• Continued significant net losses of $135.1M in 2024
• Still in clinical-stage with no approved products

Insights

Biotech Financial Analyst

Ventyx Biosciences has positioned itself as a leader in NLRP3 inhibition with multiple Phase 2 readouts expected throughout 2025 that could serve as significant valuation catalysts. The company's focus on this novel anti-inflammatory pathway spans neurodegenerative, cardiovascular, and metabolic indications - all representing substantial market opportunities with high unmet needs.

The company's $252.9 million cash position provides runway into at least H2 2026, representing approximately 2+ years of operational funding at current burn rates. This strong financial foundation is particularly notable given VTYX's current market cap of approximately $107 million, meaning the company is trading at a substantial discount to cash value. The significant reduction in operating expenses (R&D down 33% year-over-year) demonstrates disciplined capital allocation following pipeline prioritization.

The three upcoming Phase 2 readouts represent critical value-creating events:

• VTX3232 in Parkinson's disease (Q2 2025): This CNS-penetrant NLRP3 inhibitor targets neuroinflammation, a key driver of disease progression. Success here could open pathways to multiple neurodegenerative indications.
• VTX3232 in obesity/cardiometabolic conditions (H2 2025): The combination arm with semaglutide is particularly intriguing, as NLRP3 inhibition could potentially enhance GLP-1 effects by addressing inflammatory components of metabolic disease.
• VTX2735 in recurrent pericarditis (H2 2025): This indication represents a focused opportunity with competition and potential for accelerated development pathways.

The company is also seeking partnerships for its IBD assets, which have demonstrated clinical efficacy. The tamuzimod Phase 2 data published in Lancet showed robust remission rates in ulcerative colitis, while VTX958 demonstrated dose-dependent endoscopic responses in Crohn's disease.

With multiple shots on goal across diverse therapeutic areas, a cash position exceeding its market cap, and near-term clinical catalysts, Ventyx presents an intriguing risk/reward profile despite the inherent clinical development risks typical of small-cap biotechs.

Neuroscience & Inflammation Expert

Ventyx's strategic focus on NLRP3 inflammasome inhibition represents a potentially transformative approach to treating inflammatory and neurodegenerative diseases. Unlike traditional anti-inflammatory therapies that target downstream cytokines, NLRP3 inhibitors address a central regulatory hub of the innate immune response, potentially offering broader anti-inflammatory effects with improved safety profiles.

The company's VTX3232 Parkinson's disease program targets a fundamental disease mechanism that has gained significant scientific validation. Microglial activation and neuroinflammation are now understood to be primary drivers of neurodegeneration, not merely consequences. The ongoing biomarker study will provide critical proof-of-mechanism data through CSF biomarkers and TSPO PET imaging of microglial activation. Success here could establish NLRP3 inhibition as a disease-modifying approach not only for Parkinson's but potentially for multiple neurodegenerative conditions where current therapies only address symptoms.

In the cardiometabolic space, the combination of VTX3232 with semaglutide represents a mechanistically sound approach that addresses complementary pathways. While GLP-1 agonists primarily target metabolic regulation, NLRP3 inhibition could address the chronic inflammation that contributes to insulin resistance, endothelial dysfunction, and cardiovascular risk. This dual-mechanism approach could potentially enhance metabolic outcomes while addressing cardiovascular risk factors not fully mitigated by GLP-1 therapy alone.

For VTX2735 in recurrent pericarditis, Ventyx is addressing an orphan indication with significant unmet need. Current treatments include colchicine, NSAIDs, and IL-1 inhibitors like rilonacept (Arcalyst), but an oral, targeted therapy could offer advantages in safety, convenience, and potentially efficacy by addressing the specific inflammatory mechanisms driving recurrence.

Ventyx's dual approach with both CNS-penetrant and peripherally-restricted NLRP3 inhibitors provides important optionality, allowing targeted development across diverse indications while potentially optimizing the benefit-risk profile for each specific disease context.

Topline data readouts from multiple Phase 2 studies expected throughout 2025

• VTX2735 in patients with recurrent pericarditis in H2
• VTX3232 in participants with obesity and cardiometabolic risk factors in H2
• VTX3232 biomarker study in patients with early Parkinson’s disease in Q2

Cash, cash equivalents and marketable securities balance of $252.9M as of
December 31, 2024 expected to fund operations into at least H2 2026

SAN DIEGO, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”, “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases, today reported fourth quarter and full year 2024 financial results and highlighted recent pipeline and business progress.

“Heading into 2025, Ventyx has established itself as the leader in the field of NLRP3 inhibition having progressed two novel inhibitors, VTX3232 and VTX2735, into Phase 2 trials in neurodegenerative, cardiovascular, and metabolic indications. These disease states are thought to be driven by pathologic activation of the NLRP3 inflammasome,” said Raju Mohan, PhD, President and Chief Executive Officer. “We are on track to complete the Phase 2 biomarker trial of VTX3232 in Parkinson’s disease in Q2 2025 and have initiated planning for the next phase of development. In the second half of 2025, we expect to share results from the Phase 2 trial of VTX3232 in participants with obesity and cardiometabolic risk factors and the Phase 2 trial of VX2735 in patients with recurrent pericarditis. 2025 promises to be an exciting year for Ventyx and we look forward to sharing data and development plans as they become available.”

Pipeline Updates and Anticipated Milestones

NLRP3 Inhibitor Portfolio: Ventyx is advancing a portfolio of potential best-in-class oral NLRP3 inhibitors for systemic inflammatory conditions and neurodegenerative diseases, including VTX2735, a peripherally restricted NLRP3 inhibitor, and VTX3232, a CNS-penetrant NLRP3 inhibitor.

• VTX2735 in Recurrent Pericarditis: We are evaluating VTX2735 in an open-label Phase 2 trial in patients with recurrent pericarditis. The trial will enroll approximately 30 patients for a 6-week primary treatment period, followed by a 7-week extension period. Key endpoints include safety, change in the NRS (numerical rating scale) pain score, and change in high sensitivity C-reactive protein (hsCRP). Topline results are expected in the second half of 2025.

By treating and preventing disease recurrence, VTX2735 has the potential to offer a safe, effective, and convenient oral therapy for patients suffering from recurrent pericarditis.

• VTX3232 in Cardiometabolic Diseases: We are evaluating VTX3232 in a Phase 2 trial in participants with obesity and cardiometabolic risk factors. The trial is expected to enroll approximately 160 subjects randomized to one of four groups for a 12-week primary treatment period: monotherapy placebo, monotherapy VTX3232, combination semaglutide + placebo, or combination semaglutide + VTX3232. Key endpoints include safety and change in hsCRP. The trial will assess a panel of exploratory endpoints, including biomarkers of inflammation and cardiometabolic disease, as well as imaging to assess body composition and liver fat. Topline results are expected in the second half of 2025.

Data from the Phase 2 trial are expected to inform future development of the Company’s NLRP3 inhibitors in cardiometabolic diseases.

• VTX3232 in Parkinson’s Disease: The ongoing Phase 2 open-label biomarker and imaging trial of VTX3232 in patients with early Parkinson’s disease is on track to complete in the second quarter of 2025. Key endpoints include safety, pharmacokinetics, and inflammatory and disease-related biomarkers in cerebrospinal fluid and plasma, downstream of NLRP3 activation. The trial also includes exploratory TSPO (Translocator Protein) PET imaging as a marker of microglial activation.

Data from the Phase 2 study are expected to inform future development of VTX3232 in Parkinson’s disease. Beyond Parkinson’s disease, NLRP3 inhibition in the CNS may have therapeutic utility in a range of other neurodegenerative diseases, including Alzheimer’s disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Inflammatory Bowel Disease (IBD) Portfolio:

• Tamuzimod (S1P1R Modulator, ulcerative colitis): Publication of the tamuzimod Phase 2 induction data in Lancet (January 2025, doi:10.1016/S2468-1253(24)00386-8) highlighted robust clinical and endoscopic remission rates in patients treated with tamuzimod compared to placebo. Combination treatment is emerging as a compelling concept in IBD to break through the modest clinical remission rates seen with monotherapies today. Tamuzimod’s efficacy and safety profile could position it as the backbone of future combination regimens with another oral or biologic agent. The Company continues to explore partnership opportunities for tamuzimod in ulcerative colitis.

• VTX958 (TYK2 Inhibitor, Crohn’s disease): Presentation of Phase 2 data for VTX958 in Crohn’s disease at the 20^th Congress of the European Crohn’s and Colitis Organisation (ECCO, February 2025, Journal of Crohn's and Colitis, doi.org/10.1093/ecco-jcc/jjae190.1175) demonstrated a robust, dose-dependent endoscopic response at Week 12 for VTX958 compared to placebo, including a greater magnitude of reduction in two key biomarkers of inflammation, CRP and fecal calprotectin.

The totality of the Phase 2 data suggest that VTX958 may have disease-modifying benefits in Crohn’s disease. We are exploring a path for continued development of VTX958 in Crohn's disease, including potential partnership opportunities.

Fourth Quarter and 2024 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $252.9 million as of December 31, 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 $24.8 million for the fourth quarter of 2024, compared to $42.0 million for the fourth quarter of 2023. R&D expenses were $117.0 million for the year ended December 31, 2024, compared to $175.8 million for the year ended December 31, 2023.
• General and Administrative (G&A) expenses: G&A expenses were $7.6 million for the fourth quarter of 2024, compared to $8.3 million for the fourth quarter of 2023. G&A expenses were $31.4 million for the year ended December 31, 2024, compared to $32.2 million for the year ended December 31, 2023.
• Net loss: Net loss was $29.4 million for the fourth quarter of 2024, compared to $46.8 million for the fourth quarter of 2023. Net loss was $135.1 million for the year ended December 31, 2024, compared to $193.0 million for the year ended December 31, 2023.

About Ventyx Biosciences

Ventyx Biosciences is a clinical-stage biopharmaceutical company developing innovative oral therapies for patients with autoimmune, inflammatory, and neurodegenerative diseases. Our expertise in medicinal chemistry, structural biology, and immunology enables the discovery of differentiated oral small molecule therapeutics for conditions with high unmet medical need, and our extensive experience in clinical development allows the rapid progression of these drug candidates through clinical trials. Our lead portfolio of NLRP3 inhibitors includes VTX2735, a peripherally restricted NLRP3 inhibitor in Phase 2 development for recurrent pericarditis, and VTX3232, a CNS-penetrant NLRP3 inhibitor in Phase 2 development for neurodegenerative and cardiometabolic diseases. Our inflammatory bowel disease portfolio includes tamuzimod (VTX002), an S1P1R modulator, and VTX958, a TYK2 inhibitor, both of which have completed Phase 2 clinical trials. For more information on Ventyx, please visit our website at https://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 each of Ventyx’s product candidates, including the potential of VTX2735 and VTX3232, to emerge as best-in-class NLRP3 inhibitors and produce safe, effective or disease modifying results for the treatment of systemic inflammatory conditions or neurodegenerative diseases, the anticipated timing of enrollment of subjects, and the estimated total subjects enrolled, in each of the Phase 2 trials; the anticipated timing for the topline results of the ongoing Phase 2 trials of VTX3232 subjects in Parkinson’s disease in Q2 2025, and in the setting of obesity with cardiometabolic risk factors in H2 2025, and the Phase 2 trial of VTX2735 in recurrent pericarditis in H2 2025; management’s plans with respect to the commitment of internal resources toward further analysis, or development, including future studies, partnerships or other source of non-dilutive financing for tamuzimod in ulcerative colitis and VTX958 in Crohn’s disease; the potential for VTX3232 and VTX2735 in multiple cardiometabolic, systemic or neurological diseases; 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 Annual Report on Form 10-K for the full year ended December 31, 2024, filed on or about the date hereof, 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

Financial Tables

Ventyx Biosciences, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
		Three months ended December 31,								Year ended December 31,
			2024				2023				2024				2023
Operating expenses:
Research and development		$	24,821			$	42,020			$	117,002			$	175,767
General and administrative			7,597				8,326				31,448				32,227
Total operating expenses			32,418				50,346				148,450				207,994
Loss from operations			(32,418	)			(50,346	)			(148,450	)			(207,994	)
Other (income) expense:
Interest income			(3,056	)			(3,621	)			(13,416	)			(15,074	)
Other (income) expense			(11	)			28				88				42
Total other (income) expense			(3,067	)			(3,593	)			(13,328	)			(15,032	)
Net loss		$	(29,351	)		$	(46,753	)		$	(135,122	)		$	(192,962	)
Unrealized gain (loss) on marketable securities			(480	)			577				261				1,121
Foreign currency translation			(236	)			(120	)			(54	)			(48	)
Comprehensive loss		$	(30,067	)		$	(46,296	)		$	(134,915	)		$	(191,889	)
Net loss per share attributable to common shareholders, basic and diluted		$	(0.41	)		$	(0.79	)		$	(1.97	)		$	(3.30	)
Shares used to compute basic and diluted net loss per share attributable to common shareholders			70,810,758				59,076,498				68,478,172				58,542,974

 

Ventyx Biosciences, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
		December 31,
			2024				2023
Cash, cash equivalents and marketable securities		$	252,943			$	252,220
Working capital			216,849				242,080
Total assets			276,563				277,693
Total liabilities			22,518				33,770
Accumulated deficit			(554,309	)			(419,187	)
Total stockholders' equity			254,045				243,923

FAQ

When will VTYX report Phase 2 results for VTX2735 in recurrent pericarditis?

Ventyx expects to report topline results from the VTX2735 Phase 2 trial in recurrent pericarditis in the second half of 2025.

What is VTYX's cash runway based on current holdings?

With $252.9M in cash and equivalents as of December 31, 2024, VTYX expects to fund operations into at least the second half of 2026.

How much did VTYX reduce its net loss in 2024 compared to 2023?

VTYX reduced its net loss by 30%, from $193.0M in 2023 to $135.1M in 2024.

What are the key Phase 2 clinical trial milestones for VTYX in 2025?

VTYX expects VTX3232 Parkinson's disease data in Q2 2025, and both VTX3232 obesity/cardiometabolic and VTX2735 pericarditis results in H2 2025.

How much did VTYX spend on R&D in 2024 versus 2023?

R&D expenses decreased to $117.0M in 2024 from $175.8M in 2023, representing a 33.4% reduction.