VTYX Ventyx Biosciences Inc

 

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): May 09, 2024

 

 

VENTYX BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-40928	83-2996852
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
12790 El Camino Real Suite 200
San Diego, California				92130
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 760 593-4832

 

(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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		VTYX		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. ☐

 

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Item 2.02. Results of Operations and Financial Condition.

On May 9, 2024, Ventyx Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 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.

9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated May 9, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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:	May 9, 2024	By:	/s/ Raju Mohan
			Raju Mohan, Ph.D. Chief Executive Officer

 

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Exhibit 99.1

Ventyx Biosciences Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Progress

Phase 2a trials of CNS-Penetrant NLRP3 Inhibitor VTX3232 to initiate in H2 2024 in patients with early Parkinson’s disease and in participants with obesity with certain additional cardiovascular risk factors

Cash, cash equivalents and marketable securities of $302.6 million as of March 31, 2024 are expected to fund planned operations into at least the second half of 2026

Ventyx to host conference call and webcast today at 4:30PM ET

SAN DIEGO, May 9, 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 first quarter ended March 31, 2024, and highlighted recent pipeline and business progress.

“We are very excited to advance our portfolio of potential best-in-class oral NLRP3 inhibitors into Phase 2 trials in high value indications with substantial unmet medical need,” said Raju Mohan, Chief Executive Officer. “Meanwhile, we remain enthusiastic about our IBD assets and look forward to reporting topline Phase 2 data for our TYK2 inhibitor VTX958 in Crohn’s disease early in the second half of this year. We continue to believe that data from our Phase 2 study with our S1P1R modulator VTX002 in ulcerative colitis support a best-in-disease profile. We have initiated partnering efforts for VTX002 to support a pivotal Phase 3 trial.”

Pipeline Updates

We expect to initiate a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease during the second half of 2024 with biomarkers and imaging as key readouts. We also expect to initiate a Phase 2a trial of VTX3232 in the second half of 2024 in subjects with obesity and additional cardiovascular disease risk factors. Furthermore, we continue to evaluate VTX3232 in preclinical rodent models of diet-induced obesity and we look forward to providing an update on these studies later in the second quarter of this year.

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Conference Call Information

Ventyx will host a conference call today at 4:30 p.m. ET to discuss its first quarter 2024 financial results and provide a corporate update. To participate in the conference call, please dial (800) 343-4849 (U.S.) or (203) 518-9848 (international) and reference passcode VTYXQ124. A live audio webcast will be available in the Investors section of the company’s website at www.ventyxbio.com. A recording of the webcast will be available for thirty days following the call.

First 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 need 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.

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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 Ventyx’s product candidates, including the potential of VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases, and the potential of VTX002 as a best-in-disease oral agent in UC; the potentially differentiated profile of VTX002 in UC; the anticipated continued progression of the development pipeline for Ventyx’s product candidates, including the anticipated timing for the initiation of Phase 2a trials of VTX3232 in Parkinson’s disease and obesity in H2 2024, the plan to evaluate VTX3232 in preclinical rodent models of diet-induced obesity; and the plan to evaluate VTX2735 in cardiovascular diseases; management’s plans with respect to a potential pivotal Phase 3 trial for VTX002 in UC, supported by a partner or other source of non-dilutive financing; the expectation to meet with EMA for a Scientific Advice meeting regarding VTX002; the anticipated timing of announcing the results of the VTX958 Phase 2 trial in Crohn’s disease; 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-K for the quarter ended March 31, 2024, filed on or about May 9, 2024, and any 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

Patti Bank
Managing Director
ICR Westwicke
(415) 513-1284
IR@ventyxbio.com 

 

 

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Ventyx Biosciences, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

 

		Three months ended March 31,
		2024				2023
Operating expenses:
Research and development		$	33,747			$	35,437
General and administrative			8,021				7,115
Total operating expenses			41,768				42,552
Loss from operations			(41,768	)			(42,552	)
Other (income) expense:
Interest income			(3,227	)			(3,622	)
Other expense			31				1
Total other (income) expense			(3,196	)			(3,621	)
Net loss		$	(38,572	)		$	(38,931	)
Unrealized gain (loss) on marketable securities			(62	)			539
Foreign currency translation			(9	)			23
Comprehensive loss		$	(38,643	)		$	(38,369	)
Net loss per share, basic and diluted		$	(0.62	)		$	(0.68	)
Weighted average common shares outstanding, basic and diluted			61,829,976				57,638,923

Ventyx Biosciences, Inc.

Selected Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

		March 31,				December 31,
		2024				2023
Cash, cash equivalents and marketable securities		$	302,582			$	252,220
Working capital			305,225				242,080
Total assets			332,078				277,693
Total liabilities			25,082				33,770
Accumulated deficit			(457,759	)			(419,187	)
Total stockholders' equity			306,996				243,923

 

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v3.24.1.u1

Document And Entity Information	May 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 09, 2024
Entity Registrant Name	VENTYX BIOSCIENCES, INC.
Entity Central Index Key	0001851194
Entity Emerging Growth Company	false
Entity File Number	001-40928
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	83-2996852
Entity Address, Address Line One	12790 El Camino Real
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	760
Local Phone Number	593-4832
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	VTYX
Security Exchange Name	NASDAQ

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