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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2025 |
VENTYX BIOSCIENCES, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-40928 |
83-2996852 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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12790 El Camino Real Suite 200 |
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San Diego, California |
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92130 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 760 593-4832 |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, $0.0001 par value per share |
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VTYX |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 27, 2025, Ventyx Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Current Report on Form 8-K shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or in any filing under the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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VENTYX BIOSCIENCES, INC. |
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Date: |
February 27, 2025 |
By: |
/s/ Raju Mohan |
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Raju Mohan, Ph.D. |
Exhibit 99.1
Ventyx Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Corporate Progress
Topline data readouts from multiple Phase 2 studies expected throughout 2025
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, CA, February 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.
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.
Data from the Phase 2 trial are expected to inform future development of the Company's NLRP3 inhibitors in cardiometabolic diseases.
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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:
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
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.
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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
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Financial Tables
Ventyx Biosciences, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
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Three months ended December 31, |
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Year ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
24,821 |
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$ |
42,020 |
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$ |
117,002 |
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$ |
175,767 |
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General and administrative |
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7,597 |
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8,326 |
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31,448 |
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32,227 |
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Total operating expenses |
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32,418 |
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50,346 |
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148,450 |
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207,994 |
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Loss from operations |
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(32,418 |
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(50,346 |
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(148,450 |
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(207,994 |
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Other (income) expense: |
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Interest income |
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(3,056 |
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(3,621 |
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(13,416 |
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(15,074 |
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Other (income) expense |
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(11 |
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28 |
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88 |
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42 |
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Total other (income) expense |
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(3,067 |
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(3,593 |
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(13,328 |
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(15,032 |
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Net loss |
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$ |
(29,351 |
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$ |
(46,753 |
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$ |
(135,122 |
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$ |
(192,962 |
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Unrealized gain (loss) on marketable securities |
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(480 |
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577 |
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261 |
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1,121 |
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Foreign currency translation |
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(236 |
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(120 |
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(54 |
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(48 |
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Comprehensive loss |
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$ |
(30,067 |
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$ |
(46,296 |
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$ |
(134,915 |
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$ |
(191,889 |
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Net loss per share attributable to common shareholders, basic and diluted |
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$ |
(0.41 |
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$ |
(0.79 |
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$ |
(1.97 |
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$ |
(3.30 |
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Shares used to compute basic and diluted net loss per share |
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70,810,758 |
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59,076,498 |
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68,478,172 |
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58,542,974 |
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Ventyx Biosciences, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents and marketable securities |
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$ |
252,943 |
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$ |
252,220 |
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Working capital |
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216,849 |
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242,080 |
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Total assets |
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276,563 |
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277,693 |
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Total liabilities |
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22,518 |
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33,770 |
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Accumulated deficit |
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(554,309 |
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(419,187 |
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Total stockholders' equity |
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254,045 |
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243,923 |
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