Ventyx Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Corporate Progress
27 Fevereiro 2024 - 6:01PM
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 fourth quarter and full year ended December 31,
2023, and highlighted recent pipeline and business progress.
“We look forward to sharing a number of clinical
updates at our virtual investor event on March 11th,” said Raju
Mohan, Chief Executive Officer. “This includes topline results from
the Phase 2 trial of our peripheral NLRP3 inhibitor VTX2735 in
patients with CAPS and topline results from the Phase 1 trial of
our CNS-penetrant NLRP3 inhibitor VTX3232 in healthy volunteers. We
will also provide an update from the ongoing open-label extension
of the VTX002 Phase 2 trial in ulcerative colitis.”
Pipeline Updates
- 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. We will provide additional data from
the open-label extension of the Phase 2 UC trial at our virtual
investor event. Activities are underway to support initiation of a
Phase 3 trial of VTX002 in UC during the second half of 2024.
- VTX958
(TYK2 Inhibitor): We are evaluating VTX958 in a Phase 2
trial in patients with moderately to severely active Crohn’s
disease. We recently implemented a protocol amendment for the
ongoing Phase 2 trial to streamline trial design and accelerate
potential detection of an efficacy signal. As a result of the
protocol amendment, target enrollment in the trial was revised from
approximately 132 patients to approximately 93 patients. The
trial’s sole primary endpoint is now the change from baseline in
the mean Crohn’s disease activity index (CDAI) score at Week 12. We
anticipate completing randomization of the trial during the first
quarter of 2024 and we expect to report topline results from the
Phase 2 Crohn’s disease trial during the middle 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 in the Phase 2 trial is complete
and we expect to report topline results from the trial at our
virtual investor event.
- 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 is also measuring drug concentration and
target engagement in the cerebral spinal fluid. We expect to report
topline results from the Phase 1 trial of VTX3232 at our virtual
investor event. In addition to CAPS, we believe that our portfolio
of novel oral NLRP3 inhibitors is well positioned to address a
broad range of inflammatory conditions associated with activation
of the NLRP3 inflammasome. This includes systemic inflammatory
conditions, such as dermatologic, rheumatic and cardiometabolic
diseases, including obesity. We also believe that NLRP3 inhibition
in the CNS represents a compelling potential therapeutic approach
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.
Virtual Investor Event
Ventyx will host a virtual investor event on
March 11, 2024, to provide key clinical updates on our NLRP3
portfolio, including topline results from the Phase 2 trial of
VTX2735 in CAPS and topline results from the Phase 1 trial of
VTX3232 in healthy volunteers. We will also provide a clinical
update from the ongoing open-label extension of the VTX002 Phase 2
trial in ulcerative colitis. Timing and dial-in details will be
announced one week prior to the event.
Fourth Quarter and Full Year 2023
Financial Results:
- Cash
Position: Cash, cash equivalents and marketable securities
were $252.2 million as of December 31, 2023. We believe our current
cash, cash equivalents and marketable securities are sufficient to
fund our planned operations into at least the second half of
2025.
-
Research and Development (R&D)
expenses: R&D expenses were $42.0 million for the
fourth quarter of 2023, compared to $30.2 million for the fourth
quarter of 2022. R&D expenses were $175.8 million for the year
ended December 31, 2023, compared to $87.7 million for the year
ended December 31, 2022.
- General
and Administrative (G&A) expenses: G&A expenses
were $8.3 million for the fourth quarter of 2023, compared to $8.4
million for the fourth quarter of 2022. G&A expenses were $32.2
million for the year ended December 31, 2023, compared to $25.4
million for the year ended December 31, 2022.
- Net loss: Net loss
was $46.8 million for the fourth quarter of 2023, compared to $35.2
million for the fourth quarter of 2022. Net loss was $193.0 million
for the year ended December 31, 2023, compared to $108.4 million
for the year ended December 31, 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, including the positioning
of Ventyx’s NLRP3 inhibitors to address a broad range of
inflammatory conditions associated with activation of the NLRP3
inflammasome, including dermatologic, rheumatic and cardiometabolic
diseases, such as obesity; the anticipated continued progression of
the development pipeline for Ventyx’s 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 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 I, Item
1A (Risk Factors) of Ventyx’s Annual Report on Form 10-K for the
year ended December 31, 2023, filed on or about 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 ContactPatti BankManaging
DirectorICR Westwicke(415) 513-1284IR@ventyxbio.com
Ventyx
Biosciences, Inc. |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
Year ended December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
42,020 |
|
|
$ |
30,185 |
|
|
$ |
175,767 |
|
|
$ |
87,738 |
|
|
General and administrative |
|
|
8,326 |
|
|
|
8,386 |
|
|
|
32,227 |
|
|
|
25,398 |
|
|
Total
operating expenses |
|
|
50,346 |
|
|
|
38,571 |
|
|
|
207,994 |
|
|
|
113,136 |
|
|
Loss from
operations |
|
|
(50,346 |
) |
|
|
(38,571 |
) |
|
|
(207,994 |
) |
|
|
(113,136 |
) |
|
Other
(income) expense: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(3,621 |
) |
|
|
(3,185 |
) |
|
|
(15,074 |
) |
|
|
(4,669 |
) |
|
Other (income) expense |
|
|
28 |
|
|
|
(172 |
) |
|
|
42 |
|
|
|
(41 |
) |
|
Total other
(income) expense |
|
|
(3,593 |
) |
|
|
(3,357 |
) |
|
|
(15,032 |
) |
|
|
(4,710 |
) |
|
Net
loss |
|
$ |
(46,753 |
) |
|
$ |
(35,214 |
) |
|
$ |
(192,962 |
) |
|
$ |
(108,426 |
) |
|
Unrealized gain (loss) on marketable securities |
|
|
577 |
|
|
|
181 |
|
|
|
1,121 |
|
|
|
(1,023 |
) |
|
Foreign currency translation |
|
|
(120 |
) |
|
|
8 |
|
|
|
(48 |
) |
|
|
(42 |
) |
|
Comprehensive loss |
|
$ |
(46,296 |
) |
|
$ |
(35,025 |
) |
|
$ |
(191,889 |
) |
|
$ |
(109,491 |
) |
|
Net loss per
share, basic and diluted |
|
$ |
(0.79 |
) |
|
$ |
(0.62 |
) |
|
$ |
(3.30 |
) |
|
$ |
(2.07 |
) |
|
Weighted
average common shares outstanding, basic and diluted |
|
|
59,076,498 |
|
|
|
56,723,942 |
|
|
|
58,542,974 |
|
|
|
52,471,003 |
|
|
|
|
|
|
|
|
|
|
|
|
Ventyx
Biosciences, Inc. |
|
Selected
Consolidated Balance Sheet Data |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Cash, cash
equivalents and marketable securities |
|
$ |
252,220 |
|
|
$ |
356,613 |
|
|
Working
capital |
|
|
242,080 |
|
|
|
314,329 |
|
|
Total
assets |
|
|
277,693 |
|
|
|
371,400 |
|
|
Total
liabilities |
|
|
33,770 |
|
|
|
17,505 |
|
|
Accumulated
deficit |
|
|
(419,187 |
) |
|
|
(226,225 |
) |
|
Total
stockholders' equity |
|
|
243,923 |
|
|
|
353,895 |
|
|
|
|
|
|
|
|
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