Viracta Therapeutics Reports First Quarter 2023 Financial Results and Provides Clinical Program Updates
08 Mayo 2023 - 3:05PM
Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology
company focused on the treatment and prevention of virus-associated
cancers that impact patients worldwide, today announced financial
results for the first quarter of 2023 and recent clinical program
updates.
“With progress from both of our clinical
programs accelerating, we have the opportunity to achieve several
important milestones this year. NAVAL-1 is enrolling at a rapid
pace, and we look forward to readouts across multiple subtypes that
could trigger our first advancement into Stage 2 in the months
ahead,” said Mark Rothera, President and Chief Executive Officer of
Viracta. “On the solid tumor front, we are currently seeking to
optimize the dose of Nana-val and are pleased to see that its
safety profile continues to support further dose escalation into
our trial’s fifth dose level. Following the completion of the Phase
1b portion of the trial, we look forward to selecting our
recommended Phase 2 dose and advancing our efforts around Nana-val
as a potential tumor agnostic therapy for EBV-associated
cancers.”
Program Highlights and Anticipated
Milestones
Pivotal NAVAL-1 trial of Nana-val in
relapsed/refractory (R/R) EBV+
lymphoma
- NAVAL-1 continues to enroll across
each of the trial’s lymphoma subtype cohorts with more than 70
sites open globally.
- An update on NAVAL-1’s first
lymphoma subtype that may advance from Stage 1 to Stage 2 is
anticipated in the second quarter of 2023.
- Potential for additional update(s) on other NAVAL-1 lymphoma
subtype(s) in the second half of 2023.
Phase 1b/2 trial of Nana-val in patients
with recurrent/metastatic (R/M) EBV+
nasopharyngeal carcinoma (NPC) and other advanced
EBV+ solid tumors
- The trial has advanced into the
fifth dose level of the Phase 1b dose escalation portion; no
dose-limiting toxicities have been reported to date.
- Clinical data previously reported
across the first three dose levels (n=10) include one confirmed
partial response (PR) at the third dose level and three patients
achieving stable disease.
- The Company remains on track to
report complete Phase 1b dose escalation data and select a
recommended Phase 2 dose (RP2D) in the second half of 2023.
- Initiation of the trial’s Phase 2
randomized expansion cohort designed to evaluate Nana-val at the
RP2D with or without pembrolizumab in patients with R/M EBV+ NPC is
expected in the second half of 2023.
- Initiation of the trial’s
exploratory Phase 1b expansion cohort designed to evaluate Nana-val
at the RP2D in patients with other advanced EBV+ solid tumors,
including gastric carcinoma, leiomyosarcoma and lymphoepithelioma,
is expected in the second half of 2023.
First Quarter 2023 Financial
Results
- Cash position –
Cash, cash equivalents and short-term investments totaled
approximately $80.3 million as of March 31, 2023, which Viracta
expects will be sufficient to fund its operations into late 2024
excluding any additional borrowing under a $50.0 million credit
facility, of which $25.0 million remains available, at the
Company’s request, subject to the discretion of the lenders.
- Research and development
expenses – Research and development expenses were
approximately $7.6 million for the three months ended March 31,
2023, compared to approximately $6.1 million for the three months
ended March 31, 2022. The increase in research and development
expenses was primarily driven by increases in costs incurred to
support the advancement and expansion of our clinical development
programs, including incremental costs to support NAVAL-1, our
pivotal trial in R/R EBV+ lymphoma, and the initiation of our Phase
1b/2 trial for the treatment of EBV+ solid tumors, as well as an
increase in personnel-related costs.
- General and administrative
expenses – General and administrative expenses were
approximately $4.6 million for the three months ended March 31,
2023, compared to $4.3 million for the same period in 2022. The
increase in general and administrative expenses can be attributed
to an increase in personnel-related costs.
- Net loss – Net
loss was approximately $12.2 million, or $0.32 per share, (basic
and diluted) for the quarter ended March 31, 2023, compared to a
net loss of $10.5 million, or $0.28 per share (basic and diluted)
for the same period in 2022.
About NAVAL-1NAVAL-1
(NCT05011058) is a global, multicenter trial of Nana-val in R/R
EBV+ lymphoma. The trial employs a Simon two-stage design
where participants are enrolled into six indication cohorts based
on EBV+ lymphoma subtype in Stage 1. If a pre-specified
activity threshold is reached within a lymphoma subtype in Stage 1
(n=10), additional patients will be enrolled in Stage 2 for a total
of 21 patients. EBV+ lymphoma subtypes demonstrating promising
activity in Stage 2 may be further expanded following discussion
with regulators to potentially support registration.
About the Phase 1b/2 Trial of Nana-val
in R/M EBV+ NPC and Other
EBV+ Solid
TumorsThis Phase 1b/2 trial (NCT05166577) is an
open-label, multinational trial evaluating Nana-val alone and in
combination with pembrolizumab. The Phase 1b dose escalation part
is designed to evaluate safety and to determine the RP2D of
Nana-val in patients with R/M EBV+ NPC. In Phase 2, up to 60
patients with R/M EBV+ NPC will be randomized to receive
Nana-val at the RP2D with or without pembrolizumab to evaluate
safety, overall response rate, and potential pharmacodynamic
markers. Additionally, patients with other advanced EBV+ solid
tumors will be enrolled to receive Nana-val at the RP2D in a Phase
1b dose expansion cohort.
About Nana-val (Nanatinostat and
Valganciclovir)Nanatinostat is an orally available histone
deacetylase (HDAC) inhibitor being developed by Viracta.
Nanatinostat is selective for specific isoforms of Class I HDACs,
which are key to inducing viral genes that are epigenetically
silenced in Epstein-Barr virus (EBV)-associated malignancies.
Nanatinostat is currently being investigated in combination with
the antiviral agent valganciclovir as an all-oral combination
therapy, Nana-val, in various subtypes of EBV-associated
malignancies. Ongoing trials include a pivotal, global,
multicenter, open-label Phase 2 basket trial in multiple subtypes
of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a
multinational Phase 1b/2 trial in patients with EBV+ recurrent
or metastatic nasopharyngeal carcinoma and other EBV+ solid
tumors.
About Viracta Therapeutics,
Inc.Viracta is a precision oncology company focused on the
treatment and prevention of virus-associated cancers that impact
patients worldwide. Viracta’s lead product candidate is an all-oral
combination therapy of its proprietary investigational drug,
nanatinostat, and the antiviral agent valganciclovir (collectively
referred to as Nana-val). Nana-val is currently being evaluated in
multiple ongoing clinical trials, including a pivotal, global,
multicenter, open-label Phase 2 basket trial for the treatment of
multiple subtypes of relapsed/refractory Epstein-Barr
virus-positive (EBV+) lymphoma (NAVAL-1), as well as a
multinational, open-label Phase 1b/2 trial for the treatment of
EBV+ recurrent or metastatic nasopharyngeal carcinoma and
other advanced EBV+ solid tumors. Viracta is also pursuing the
application of its “Kick and Kill” approach in other
virus-related cancers.
For additional information please visit
www.viracta.com.
Forward Looking StatementsThis
communication contains "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements regarding: the details,
timeline and expected progress for Viracta's ongoing and
anticipated trials and updates regarding the same, including NAVAL-
1 and the Phase 1b/2 trial of Nana-val in EBV+ solid tumor and
the sufficiency of current cash reserves to fund ongoing operations
for the specified period. Risks and uncertainties related to
Viracta that may cause actual results to differ materially from
those expressed or implied in any forward-looking statement
include, but are not limited to: Viracta's ability to successfully
enroll patients in and complete its ongoing and planned clinical
trials; the timing of initiation of Viracta's planned clinical
trials; the timing of the availability of data from Viracta's
clinical trials; previous preclinical and clinical results may not
be predictive of future clinical results; the timing of any planned
investigational new drug application or new drug application;
Viracta's plans to research, develop and commercialize its current
and future product candidates; the clinical utility, potential
benefits and market acceptance of Viracta's product candidates;
Viracta's ability to manufacture or supplying nanatinostat,
valganciclovir and pembrolizumab for clinical testing; and
Viracta's estimates regarding future expenses, capital requirements
and need for additional financing in the future.
These risks and uncertainties may be amplified
by the ongoing COVID-19 pandemic, which has caused significant
economic uncertainty. If any of these risks materialize or
underlying assumptions prove incorrect, actual results could differ
materially from the results implied by these forward-looking
statements. Additional risks and uncertainties that could cause
actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption "Risk Factors" and elsewhere in Viracta's reports and
other documents that Viracta has filed, or will file, with the SEC
from time to time and available at www.sec.gov.
The forward-looking statements included in this
communication are made only as of the date hereof. Viracta assumes
no obligation and does not intend to update these forward-looking
statements, except as required by law or applicable regulation.
Investor Relations Contact:Ashleigh BarretoHead
of Investor Relations & Corporate CommunicationsViracta
Therapeutics, Inc.abarreto@viracta.com
SOURCE Viracta Therapeutics, Inc.
-- Financial tables attached
–
Viracta
Therapeutics, Inc. |
Selected
Balance Sheet Highlights |
(in
thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
|
Cash, cash equivalents and short-term investments |
$ |
80,332 |
|
|
$ |
91,043 |
|
Total
assets |
$ |
85,781 |
|
|
$ |
95,991 |
|
Total
liabilities |
$ |
34,668 |
|
|
$ |
34,888 |
|
Stockholders' equity |
$ |
51,113 |
|
|
$ |
61,103 |
|
|
|
|
|
|
|
Viracta
Therapeutics, Inc. |
Condensed
Consolidated Statement of Operations and Comprehensive
Loss |
(in
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2023 |
|
2022 |
Operating
expenses: |
|
|
|
|
|
Research and development |
$ |
7,607 |
|
|
$ |
6,096 |
|
General and administrative |
|
4,600 |
|
|
|
4,336 |
|
Total
operating expenses |
|
12,207 |
|
|
|
10,432 |
|
Loss from
operations |
|
(12,207 |
) |
|
|
(10,432 |
) |
Total other
expense |
|
(2 |
) |
|
|
(114 |
) |
Net
loss |
|
(12,209 |
) |
|
|
(10,546 |
) |
Unrealized
gain on short-term investments |
|
91 |
|
|
|
— |
|
Comprehensive loss |
|
(12,118 |
) |
|
|
(10,546 |
) |
Net loss per
share, basic and diluted |
$ |
(0.32 |
) |
|
$ |
(0.28 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
38,458,837 |
|
|
|
37,535,874 |
|
Viracta Therapeutics (NASDAQ:VIRX)
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