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
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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):
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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 May 12, 2022, Ventyx Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2022. 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. |
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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: |
May 12, 2022 |
By: |
/s/ Raju Mohan |
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Raju Mohan, Ph.D. |
Exhibit 99.1
Ventyx Biosciences Reports First Quarter 2022 Financial Results and Highlights Recent Corporate Progress
Topline Phase 1 data for our allosteric TYK2 inhibitor, VTX958, expected in early Q3 2022
Topline Phase 1 data for our selective NLRP3 inhibitor, VTX2735, expected in Q2 2022
Announced the appointment of William Sandborn, MD, as President and Chief Medical Officer, strengthening our deep expertise in immunology
ENCINITAS, Calif., May 12, 2022 (GLOBE NEWSWIRE) – Ventyx Biosciences, Inc. (Nasdaq: VTYX), (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a range of inflammatory diseases with significant unmet medical need, today announced financial results for the first quarter ended March 31, 2022 and highlighted recent pipeline and business progress.
“I am proud of our team’s continued efforts as we execute across our diverse pipeline of three clinical-stage programs targeting TYK2, S1P1R and NLRP3,” said Raju Mohan, Chief Executive Officer. “We look forward to sharing important data updates in the coming months, including Phase 1 data for our lead NLRP3 inhibitor VTX2735 in the second quarter of 2022, and Phase 1 data for VTX958, our novel allosteric TYK2 inhibitor, early in the third quarter of this year. I am also very excited to welcome Dr. Bill Sandborn to our leadership team as we continue to execute on our clinical strategy, including the planned initiation of three Phase 2 trials for VTX958 in the second half of 2022.”
Recent Corporate Highlights
Pipeline Update
We completed the single-ascending dose (SAD) Phase 1 trial for VTX958 in healthy volunteers. The multiple-ascending dose (MAD) Phase 1 trial for VTX958 is ongoing. We intend to provide a topline clinical update in the early part of the third quarter of 2022, and expect to include a summary of safety, exposure and target engagement, which we believe may support the differentiated clinical profile for VTX958. We plan to advance VTX958 into Phase 2 trials in psoriasis, Crohn’s disease and psoriatic arthritis beginning in the second half of 2022.
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First Quarter 2022 Financial Results:
The amounts presented below for the first quarter of 2022 reflect the financial results of Ventyx Biosciences, Inc. and its two acquired, wholly-owned subsidiaries, Oppilan Pharma Ltd. (Oppilan) and Zomagen Biosciences Ltd. (Zomagen), on a consolidated basis. The amounts presented below for the first quarter of 2021 reflect the financial results of Ventyx Biosciences, Inc., as well as the financial results of Oppilan and Zomagen from the date of acquisition (February 26, 2021) to March 31, 2021, on a consolidated basis.
Conference Call Information
Ventyx will host a conference call beginning today, Thursday, May 12, at 1:30 p.m. PT/ 4:30 p.m. ET to discuss these first quarter 2022 financial results and provide a corporate update. To access the live call, dial (877) 788-3665 (US) or (615) 489-8863 (international) and refer to conference ID 5790909. A live and archived audio webcast will be accessible in the Investors section of the company's website at ir.ventyxbio.com. The replay of the call will be available for 30 days.
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 immunology markets from injectable to oral drugs. Our current pipeline includes three clinical-stage programs targeting TYK2, S1P1R and NLRP3, positioning us to become a leader in the development of oral immunology therapies. Ventyx is headquartered in Encinitas, 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: management’s belief that three of Ventyx’s product candidates are potentially being best-in-class; the anticipated timing of commencement, enrollment and completion of clinical trials for Ventyx’s product candidates; the anticipated timing of releasing data for the VTX958 MAD trial and advancing VTX958 into Phase 2 trials in psoriasis, psoriatic arthritis and Crohn’s disease; the anticipated timing for releasing top-line data for the Phase 2 randomized, placebo-controlled clinical trial for VTX002 and the expectation that such trial, along with an additional Phase 3 trial, may serve as the first of two pivotal trials required for registration; the potential of Ventyx’s product candidates to address a broad range of immune-mediated diseases; the anticipated timing for reporting data from the Phase 1 trial forVTX2735 in healthy volunteers and plans for advancing VTX2735 into one or more proof-of-concept trials; anticipated timing for submitting an IND application for VTX3232; plans to advance Ventyx’s product candidates; 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; disruption to our operations from the ongoing global outbreak of the COVID-19 pandemic, or from the ongoing military conflict in Ukraine, including clinical trial delays; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Ventyx’s clinical trials and preclinical studies for its product candidates; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as the 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 our 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 filed on the date hereof, 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)
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Three Months Ended |
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March 31, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development (includes related party amounts of $203 and $208, |
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$ |
17,409 |
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$ |
24,601 |
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General and administrative (includes related party amounts of $0 and $116, |
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5,338 |
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747 |
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Total operating expenses |
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22,747 |
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25,348 |
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Loss from operations |
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(22,747 |
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(25,348 |
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Other (income) expense: |
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Other income |
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(15 |
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— |
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Interest expense - related party |
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— |
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99 |
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Change in fair value of notes and derivative - related party |
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— |
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11,051 |
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Change in fair value of Series A tranche liability |
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— |
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1,147 |
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Total other (income) expense |
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(15 |
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12,297 |
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Net loss |
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(22,732 |
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(37,645 |
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Deemed dividend |
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— |
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(1,552 |
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Net loss attributable to common shareholders |
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$ |
(22,732 |
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$ |
(39,197 |
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Net loss |
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$ |
(22,732 |
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$ |
(37,645 |
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Unrealized loss on marketable securities |
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(942 |
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— |
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Foreign currency translation |
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42 |
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2 |
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Comprehensive loss |
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$ |
(23,632 |
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$ |
(37,643 |
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Net loss per share attributable to common shareholders, basic and diluted |
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$ |
(0.45 |
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$ |
(15.22 |
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Shares used to compute basic and diluted net loss per share attributable to common |
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50,585,255 |
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2,575,619 |
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Ventyx Biosciences, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
273,147 |
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$ |
286,724 |
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Working capital |
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239,714 |
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250,737 |
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Total assets |
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277,953 |
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291,482 |
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Total liabilities |
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18,830 |
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12,283 |
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Accumulated deficit |
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(140,531 |
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(117,799 |
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Total stockholders' equity |
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259,123 |
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279,199 |
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