Ventyx Biosciences Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Progress
09 Noviembre 2023 - 3:01PM
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 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-1β, 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.
- 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 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) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
49,750 |
|
|
$ |
25,468 |
|
|
$ |
133,747 |
|
|
$ |
57,553 |
|
General and administrative |
|
|
8,201 |
|
|
|
5,952 |
|
|
|
23,901 |
|
|
|
17,012 |
|
Total operating expenses |
|
|
57,951 |
|
|
|
31,420 |
|
|
|
157,648 |
|
|
|
74,565 |
|
Loss from operations |
|
|
(57,951 |
) |
|
|
(31,420 |
) |
|
|
(157,648 |
) |
|
|
(74,565 |
) |
Other (income) expense: |
|
|
|
|
|
|
|
|
Interest income |
|
|
(3,932 |
) |
|
|
(1,010 |
) |
|
|
(11,453 |
) |
|
|
(1,484 |
) |
Other expense |
|
|
8 |
|
|
|
52 |
|
|
|
14 |
|
|
|
131 |
|
Total other (income) expense |
|
|
(3,924 |
) |
|
|
(958 |
) |
|
|
(11,439 |
) |
|
|
(1,353 |
) |
Net loss |
|
$ |
(54,027 |
) |
|
$ |
(30,462 |
) |
|
$ |
(146,209 |
) |
|
$ |
(73,212 |
) |
Unrealized gain (loss) on marketable securities |
|
|
192 |
|
|
|
17 |
|
|
|
544 |
|
|
|
(1,204 |
) |
Foreign currency translation |
|
|
11 |
|
|
|
(38 |
) |
|
|
72 |
|
|
|
(50 |
) |
Comprehensive loss |
|
$ |
(53,824 |
) |
|
$ |
(30,483 |
) |
|
$ |
(145,593 |
) |
|
$ |
(74,466 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.92 |
) |
|
$ |
(0.59 |
) |
|
$ |
(2.51 |
) |
|
$ |
(1.43 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
58,880,427 |
|
|
|
51,667,768 |
|
|
|
58,363,174 |
|
|
|
51,037,771 |
|
|
|
|
|
|
|
|
|
|
Ventyx Biosciences, Inc. |
Selected Consolidated Balance Sheet Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and marketable securities |
|
$ |
300,819 |
|
|
$ |
356,613 |
|
Working capital |
|
|
281,884 |
|
|
|
314,329 |
|
Total assets |
|
|
321,701 |
|
|
|
371,400 |
|
Total liabilities |
|
|
38,061 |
|
|
|
17,505 |
|
Accumulated deficit |
|
|
(372,434 |
) |
|
|
(226,225 |
) |
Total stockholders' equity |
|
|
283,640 |
|
|
|
353,895 |
|
Ventyx Biosciences (NASDAQ:VTYX)
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Ventyx Biosciences (NASDAQ:VTYX)
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