Ventyx Biosciences Reports Third Quarter 2023 Financial Results and
Highlights Recent Corporate Progress
Ventyx to provide updates across clinical-stage portfolio in the
first quarter of 2024
Cash, cash equivalents and marketable securities of $300.8 million
as of September 30, 2023
SAN DIEGO, November 9, 2023 (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, 2023, and highlighted recent pipeline and business
progress.
“We are committed to progressing our wholly-owned portfolio of
novel small molecule drug candidates,” said Raju Mohan, Chief
Executive Officer. “We look forward to providing important pipeline
updates in the first quarter of 2024, including the VTX958 Phase 2
Crohn’s disease interim efficacy analysis, an update from the
open-label extension of the VTX002 Phase 2 trial in ulcerative
colitis, Phase 2 data for our peripheral NLRP3 inhibitor, VTX2735,
in CAPS, and Phase 1 data for our novel CNS penetrant NLRP3
inhibitor, VTX3232, in healthy volunteers.”
Pipeline Updates
▪
VTX958 (TYK2 Inhibitor):
We recently announced topline results from the Phase 2 trial of
VTX958 in plaque psoriasis. While the trial met its primary and
secondary endpoints, the efficacy results did not meet our internal
target to support further development of VTX958 in psoriasis.
Accordingly, we have elected to terminate ongoing activities in the
Phase 2 trials of VTX958 in plaque psoriasis and psoriatic
arthritis. The ongoing Phase 2 trial of VTX958 in Crohn’s disease
will continue with the addition of an interim efficacy analysis to
be conducted in the first quarter of 2024.
▪
VTX002 (S1P1R Modulator):
In October 2023, we announced positive results from the Phase 2
trial of VTX002 in patients with moderately to severely active
ulcerative colitis (UC). We believe these data establish VTX002 as
a potential best-in-disease oral agent in UC based on its
differentiated efficacy profile, including a high rate of complete
endoscopic remission, and its potential best-in-class safety
profile. Phase 3 planning activities are underway. We expect to
provide an update from the open-label extension of the Phase 2
trial in ulcerative colitis trial during the first quarter of
2024.
▪
VTX2735 (Peripheral NLRP3 Inhibitor):
We are conducting a Phase 2 trial of VTX2735 in patients with
familial cold autoinflammatory syndrome (FCAS). FCAS is the most
common subset of cryopyrin-associated periodic syndrome (CAPS), a
group of rare autoinflammatory conditions caused by
gain-of-function mutations in the NLRP3 gene. Patient enrollment is
progressing, and we expect to provide an update on the trial in the
first quarter of 2024. In addition to CAPS, we believe systemic
NLRP3 inhibition with VTX2735 may have therapeutic potential across
a broad range of chronic inflammatory conditions that are
characterized by NLRP3-induced excess IL-1ß, including
dermatologic, rheumatic and cardiovascular diseases.
▪
VTX3232 (CNS-penetrant NLRP3 Inhibitor):
We are conducting a Phase 1 trial of VTX3232 in adult healthy
volunteers. The trial is designed to characterize the safety,
pharmacokinetics and pharmacodynamics of VTX3232 in blood, and will
also measure drug concentration and target engagement in the
cerebral spinal fluid. We believe that the profile of VTX3232 may
establish it as a compelling therapeutic for a range of
neuroinflammatory conditions with high unmet medical need,
including Parkinson’s disease, multiple sclerosis, Alzheimer’s
disease and amyotrophic lateral sclerosis, among others. We expect
to provide an update on the Phase 1 trial of VTX3232 in the first
quarter of 2024.
Third Quarter 2023 Financial Results
▪
Cash Position:
Cash, cash equivalents and marketable securities were $300.8
million as of September 30, 2023.
▪
Research
and Development (R&D) expenses:
R&D expenses were $49.8 million for the quarter ended September
30, 2023, compared to $25.5 million for the quarter ended September
30, 2022.
▪
General and Administrative (G&A) expenses:
G&A expenses were $8.2 million for the quarter ended September
30, 2023, compared to $6.0 million for the quarter ended September
30, 2023.
1
▪
Net loss:
Net loss was $54.0 million for the quarter ended September 30,
2023, compared to $30.5 million for the quarter ended September 30,
2022.
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 internally discovered
clinical programs targeting TYK2, S1P1R and NLRP3, positioning us
to become a leader in the development of oral immunology therapies.
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 and the anticipated continued progression of the
development pipeline for such product candidates; the anticipated
continuance of the Phase 2 trial of VTX958 in Crohn's disease; the
therapeutic and commercial potential of VTX002 in ulcerative
colitis, including its potential as a best-in-disease oral agent
and its potential best-in-class safety profile; and the anticipated
timing of updates regarding the VTX958 Phase 2 trial in Crohn's
disease, the VTX3232 Phase 1 trial, the VTX2735 Phase 2 trial in
CAPS, and the open-label extension of the VTX002 Phase 2 trial. 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; 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; disruption to Ventyx’s operations from the ongoing
military conflicts in Ukraine and the Middle East, including
clinical trial delays; 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, 2023, filed on or about November 9, 2023, 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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