UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
|
|
(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:
|
|
Trading |
|
|
|
|
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 November 7, 2024, Ventyx Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 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.
9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
|
104 |
|
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.
|
|
|
VENTYX BIOSCIENCES, INC. |
|
|
|
|
Date: |
November 7, 2024 |
By: |
/s/ Raju Mohan |
|
|
|
Raju Mohan, Ph.D. |
Exhibit 99.1
Ventyx Biosciences Reports Third Quarter 2024 Financial Results and Highlights Recent Corporate Progress
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 $274.8M as of September 30, 2024 expected to fund operations into at least H2 2026
SAN DIEGO, November 7, 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 VT3232 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
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.
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
Third Quarter 2024 Financial Results:
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 |
|