Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage
precision oncology company focused on the treatment and prevention
of virus-associated cancers that impact patients worldwide, today
provided a business update and reported financial results for the
third quarter of 2023.
“During our recently held R&D Day, we
provided multiple clinical and strategic updates, which further
positioned Nana-val as a differentiated potential therapeutic
option for patients with EBV-associated cancers,” said Mark
Rothera, President and Chief Executive Officer of Viracta.
“Preliminary results from the PTCL cohort of the NAVAL-1 trial
demonstrated overall and complete response rates of 40%, which are
consistent with results from our previous Phase 1b/2 study and
exceeds the current standard of care for this patient population
with high unmet medical need. We continue to believe that Nana-val
is an ideal candidate for the accelerated approval pathway and we
remain on track to complete enrollment of the Nana-val PTCL Stage 2
cohort and engage with FDA in 2024.”
“We also reported interim data from the Phase
1b/2 trial of Nana-val in advanced EBV-positive solid tumors with
partial responses confirmed at higher doses. Given there have been
no dose-limiting toxicities observed to date, we plan to evaluate
higher doses of Nana-val that incorporate a novel split daily
dosing schedule and determine the recommended Phase 2 dose of
Nana-val for our solid tumor program in 2024. We have a
well-defined strategic path forward, and with the PTCL indication
leading the way, we continue to explore opportunities to maximize
the therapeutic potential of Nana-val across other
indications.”
Clinical Trial Updates and Anticipated
Milestones
Pivotal NAVAL-1 study of Nana-val in patients
with relapsed or refractory (R/R) Epstein-Barr virus-positive
(EBV+) lymphoma
- As of the data cutoff date of June
30, 2023, initial results from the first five patients with R/R
EBV+ peripheral T-cell lymphoma (PTCL) treated with Nana-val showed
an overall response rate (ORR) and complete response rate (CRR) of
40%.
- Completion of enrollment into the
nanatinostat monotherapy arm (n=10) and Nana-val combination arm
(n=10) of the NAVAL-1 R/R EBV+ PTCL cohort is anticipated by
year-end 2023.
- Amended the NAVAL-1 protocol to
additionally enroll second-line patients across all cohorts,
including diffuse large B-cell lymphoma (DLBCL) and post-transplant
lymphoproliferative disorder (PTLD).
- Anticipated 2024
milestones:
- Stage 1 data from both arms of the
R/R EBV+ PTCL cohort (in patients treated with nanatinostat with or
without valganciclovir).
- Completion of enrollment into Stage
2 of the Nana-val R/R EBV+ PTCL cohort (n=21).
- U.S. Food and Drug Administration
(FDA) meeting to discuss additional requirements for accelerated
approval for the treatment of patients with R/R EBV+ PTCL.
- Stage 2 data from the Nana-val R/R
EBV+ PTCL cohort.
Additional response and durability assessments
from the Phase 1b/2 trial (Study 201) of Nana-val in patients with
R/R EBV+ lymphoma as of the May 4, 2023 data cutoff date
- For patients with R/R EBV+ PTCL,
median duration of response (DoR) was 17.3 months with an ORR/CRR
of 50%/38% (n=8).
- For patients with R/R EBV+ DLBCL,
median DoR has not yet been reached, with three patients remaining
in response with DoRs of 11.1 months (complete response [CR]), 36.8
months (partial response [PR]), and 41.9 months (CR), with an
ORR/CRR of 67%/33% (n=9).
- Expanded and extended safety data
demonstrated Nana-val regimen was generally well-tolerated with the
potential to combine with other chemo/immunotherapies.
New interim clinical data in Phase 1b/2 study of
Nana-val in patients with advanced EBV+ solid tumors (Study 301)
highlight the opportunity to dose escalate further with a novel
dosing regimen to potentially drive additional responses in this
patient population. This approach is supported by growing
preclinical data.
- Enrollment completed through the
fifth dose level without any dose-limiting toxicities
reported.
- Best responses to date included two
confirmed PRs at the higher dose levels and five stable diseases in
17 patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal
carcinoma (NPC).
- In a preclinical murine xenograft
model, split daily dosing (SDD) of Nana-val had superior anti-tumor
activity than intermittent (four days on/three days off) once-daily
dosing, which supports the evaluation of an SDD regimen in patients
with advanced EBV+ solid tumors.
- Anticipated 2024
milestones:
- Additional dose levels are planned
with Nana-val on an SDD schedule to select a recommended Phase 2
dose (RP2D); enrollment anticipated to be resumed by year-end
2023.
- Initiation of the clinical trial’s
randomized Phase 2 expansion cohort designed to further evaluate
Nana-val at the RP2D.
Business Update
- On October 4, 2023, Viracta hosted
an R&D Day highlighting Nana-val clinical programs in
EBV-associated cancers. The R&D Day featured key opinion
leaders, Pierluigi Porcu, M.D. and Robert A. Baiocchi, M.D., Ph.D.
- Drs. Porcu and Baiocchi discussed
the current treatment landscape of EBV+ lymphomas and Nana-val’s
opportunity to address the unmet medical needs of this unique
cancer segment.
- Members of Viracta’s senior
management team provided updates on the Nana-val clinical
development programs in patients with R/R EBV+ lymphoma and in
patients with R/M EBV+ NPC.
- A replay of the presentation is
available here
Third Quarter 2023 Financial
Results
- Cash position –
Cash, cash equivalents, and short-term investments totaled
approximately $63.0 million as of September 30, 2023, which is
anticipated to fund Viracta’s operations through late 2024 and does
not include any adjustments that may arise from uncertainties
related to our ability to continue as a going concern. This also
excludes any additional borrowing under a $50.0 million credit
facility, of which $25.0 million remains available, at the
Company’s request and subject to the discretion of the
lenders.
- Research and development
expenses – Research and development (R&D) expenses
were approximately $8.2 million and $24.0 million for the three and
nine months ended September 30, 2023, respectively, compared to
approximately $7.1 million and $19.6 million for the same periods
in 2022. This increase in R&D 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 study of Nana-val
in patients with R/R EBV+ lymphoma, and the initiation of our Phase
1b/2 study of Nana-val for the treatment of patients with EBV+
solid tumors, as well as an increase in personnel-related
costs.
- General and administrative
expenses – General and administrative (G&A) expenses
were approximately $4.3 million and $13.2 million for the three and
nine months ended September 30, 2023, respectively, compared to
$10.9 million and $19.5 million for the same periods in 2022. The
decrease in G&A expenses was largely due to a non-recurring
share-based compensation expense of $5.6 million associated with
modifications to certain equity awards in conjunction with a
separation agreement for the former Chief Executive Officer in
September 2022. In addition, $0.8 million in one-time
severance-related charges were recorded in the three and nine
months ended September 30, 2022 in accordance with the terms of the
separation agreement.
- Net loss – Net
loss was approximately $12.6 million, or $0.33 per share, (basic
and diluted) for the quarter ended September 30, 2023, compared to
a net loss of $17.7 million, or $0.47 per share, (basic and
diluted) for the same period in 2022. Net loss was approximately
$37.3 million, or $0.97 per share, (basic and diluted) for the nine
months ended September 30, 2023, compared to a net loss of $38.9
million, or $1.03 per share, (basic and diluted) for the same
period in 2022.
About NAVAL-1NAVAL-1
(NCT05011058) is a global, multicenter, clinical trial of Nana-val
in patients with relapsed or refractory (R/R) Epstein-Barr
virus-positive (EBV+) lymphoma. This trial employs a Simon
two-stage design where, in Stage 1, participants are enrolled into
one of three indication cohorts based on EBV+ lymphoma subtype. If
a pre-specified antitumor activity threshold is reached within a
lymphoma subtype in Stage 1 (n=10), then additional patients will
be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma
subtypes demonstrating promising antitumor activity in Stage 2 may
be further expanded following discussion with regulators to
potentially support registration.
About the Phase 1b/2 Study of Nana-val
in R/M EBV+ NPC and Other
Advanced EBV+ Solid
TumorsThis Phase 1b/2 trial (NCT05166577) is an
open-label, multinational clinical 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
Recommended Phase 2 Dose (RP2D) of Nana-val in patients with
recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+)
nasopharyngeal carcinoma (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 further evaluate antitumor
activity, safety and tolerability, pharmacokinetics, and potential
pharmacodynamic biomarkers. 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 or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as
a multinational Phase 1b/2 clinical trial in patients with
recurrent or metastatic (R/M) EBV+ NPC and other EBV+ solid
tumors.
About EBV-Associated
CancersApproximately 90% of the world's adult population
is infected with EBV. Infections are commonly asymptomatic or
associated with mononucleosis. Following infection, the virus
remains latent in a small subset of cells for the duration of the
patient's life. Cells containing latent virus are increasingly
susceptible to malignant transformation. Patients who are
immunocompromised are at an increased risk of developing
EBV-positive (EBV+) lymphomas. EBV is estimated to be associated
with approximately 2% of the global cancer burden including
lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.
About Viracta Therapeutics,
Inc.Viracta is a clinical-stage 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 or refractory (R/R)
Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a
multinational, open-label Phase 1b/2 clinical trial for the
treatment of patients with recurrent or metastatic (R/M) EBV+
nasopharyngeal carcinoma (NPC) 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 clinical trials and updates regarding the same, the
Company’s expectations related to the FDA submission process and
timelines, expectations regarding our target patient populations,
and expectations regarding our cash runway. 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; Viracta's plans to develop and
commercialize its product candidates, including all oral
combinations of nanatinostat and valganciclovir; 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 supply nanatinostat, valganciclovir, and
pembrolizumab for clinical testing; Viracta's ability to identify
additional products or product candidates with significant
commercial potential; developments and projections relating to
Viracta's competitors and its industry; the impact of government
laws and regulations; Viracta's ability to protect its intellectual
property position; and Viracta's estimates regarding its ability to
fund ongoing operations to or beyond late 2024, future expenses,
capital requirements, and need for additional financing in the
future.
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. |
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Selected Balance Sheet Highlights |
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(in thousands) |
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September 30, |
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December 31, |
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2023 |
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2022 |
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(Unaudited) |
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Cash, cash equivalents and short-term investments |
$ |
62,952 |
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$ |
91,043 |
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Total assets |
$ |
66,437 |
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$ |
95,991 |
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Total liabilities |
$ |
36,429 |
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$ |
34,888 |
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Stockholders' equity |
$ |
30,008 |
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$ |
61,103 |
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Viracta Therapeutics, Inc. |
Condensed Consolidated Statement of Operations and
Comprehensive Loss |
(in thousands except share and per share
data) |
(Unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
8,158 |
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$ |
7,139 |
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$ |
23,962 |
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$ |
19,559 |
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General and administrative |
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4,317 |
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10,939 |
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13,170 |
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19,456 |
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Total operating expenses |
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12,475 |
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18,078 |
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37,132 |
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39,015 |
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Loss from operations |
|
(12,475 |
) |
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|
(18,078 |
) |
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(37,132 |
) |
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|
(39,015 |
) |
Total other income (expense) |
|
(125 |
) |
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335 |
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(161 |
) |
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|
144 |
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Net loss |
|
(12,600 |
) |
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|
(17,743 |
) |
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(37,293 |
) |
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|
(38,871 |
) |
Unrealized gain (loss) on short-term investments |
|
50 |
|
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(199 |
) |
|
|
113 |
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(199 |
) |
Comprehensive loss |
|
(12,550 |
) |
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|
(17,942 |
) |
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(37,180 |
) |
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|
(39,070 |
) |
Net loss per
share, basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.47 |
) |
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$ |
(0.97 |
) |
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$ |
(1.03 |
) |
Weighted-average common shares outstanding, basic and diluted |
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38,683,858 |
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37,705,517 |
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38,568,515 |
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37,614,166 |
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Grafico Azioni Viracta Therapeutics (NASDAQ:VIRX)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Viracta Therapeutics (NASDAQ:VIRX)
Storico
Da Giu 2023 a Giu 2024