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
second quarter of 2023.
“In the second quarter of 2023, we achieved key
milestones in the pivotal NAVAL-1 study of Nana-val by enabling the
advancement of this global clinical trial into Stage 2 and
establishing EBV-positive PTCL as Nana-val’s leading indication.
This milestone was based on a strong signal of efficacy with a
favorable safety profile, consistent with our promising Phase 1b/2
clinical trial data,” said Mark Rothera, President and Chief
Executive Officer of Viracta. “Given the high unmet medical need in
patients with EBV-positive PTCL and our positioning of Nana-val as
a potential important treatment option for these patients, our goal
is to move forward rapidly towards registration in the U.S. We
intend to complete Stage 2 enrollment and meet with the U.S. Food
and Drug Administration in 2024 to discuss additional requirements
for regulatory approval.”
Darrel P. Cohen, M.D., Ph.D., Chief Medical
Officer of Viracta commented, “We are thrilled to have our Phase
1b/2 study results published in a high-quality peer-reviewed
journal, such as Blood Advances, which underscores the potential of
Nana-val to treat patients with EBV-positive lymphoma and elevates
the importance of the NAVAL-1 trial. Following the advancement of
the PTCL cohort and to optimize our resources behind this trial, we
have strategically prioritized key subtypes of EBV-positive
lymphoma where we can address high unmet medical needs, increase
the probability of success, and focus on the largest EBV-positive
lymphoma patient populations.”
Clinical Trial Updates and Anticipated
Milestones
Pivotal NAVAL-1 study of Nana-val in patients
with relapsed or refractory (R/R) EBV+ lymphoma
- The EBV+ peripheral T-cell lymphoma
(PTCL) cohort of the pivotal NAVAL-1 clinical trial met the
efficacy threshold for expansion into Stage 2 of the study, which
was based upon a pre-specified minimum number of objective
responses achieved; initial data are consistent with results from
the Phase 1b/2 study and establish EBV+ PTCL as Nana-val’s leading
indication.
- Strategically prioritized three
lymphoma subtypes: (1) EBV+ PTCL, a T-cell lymphoma with high unmet
medical need; (2) EBV+ diffuse large B-cell lymphoma (DLBCL), an
aggressive and distinct B-cell lymphoma subtype characterized by
adverse clinical outcomes, and (3) EBV+ PTLD, a potentially fatal
complication after transplantation, which is highly associated with
EBV.
- Prioritization also enables the
allocation of resources to those indications with the greatest
probability of success and market opportunity in key
geographies.
- Enrollment into HIV-lymphoma and
Hodgkin lymphoma cohorts will be discontinued.
- Patients with extranodal NK/T-cell
lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma
will continue to be enrolled.
- Completion of enrollment into Stage
2 of the R/R EBV+ PTCL cohort and engagement with FDA on additional
requirements for regulatory approval is anticipated in 2024.
Phase 1b/2 clinical trial of Nana-val in
patients with R/R EBV+ lymphoma
- In August 2023, Viracta announced
the publication in Blood Advances featuring results from an
open-label, multicenter, Phase 1b/2 study of Nana-val in patients
with R/R EBV+ lymphoma titled, “Targeted therapy with nanatinostat
and valganciclovir in recurrent Epstein-Barr virus-positive
lymphoid malignancies: a Phase 1b/2 study.”
- The publication included a more
recent data cut reflecting multiple patients with an ongoing
durable response exceeding 30 months across multiple EBV+ lymphoma
subtypes, including EBV+ PTCL and EBV+ DLBCL, and two patients with
an ongoing response of approximately 36 months.
- Nana-val was generally well
tolerated with reversible low-grade toxicities. The most commonly
observed treatment emergent adverse events were reversible
cytopenias, low-grade creatinine elevations, and gastrointestinal
symptoms.
Phase 1b/2 study of Nana-val in patients with
recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC)
and other advanced EBV+ solid tumors
- Enrollment completed through the
fifth dose level of the Phase 1b dose escalation portion of the
trial without any dose-limiting toxicities reported.
- The Company remains on track to
report complete Phase 1b dose escalation data and select a
Recommended Phase 2 Dose (RP2D) of Nana-val in the second half of
2023.
- Initiation of the trial’s
randomized Phase 2 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.
Business Updates
Strengthened the leadership team with the
appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical
Officer (CMO)
- In August 2023, Dr. Cohen was
appointed as CMO to oversee the clinical development and regulatory
advancement of Viracta’s pipeline. Dr. Cohen is a highly
accomplished physician and biopharmaceutical executive with more
than 25 years of oncology clinical research and drug development
experience in both solid tumors and hematologic malignancies. Dr.
Cohen was involved in multiple successful regulatory submissions of
new targeted cancer drugs such as SUTENT® (sunitinib), XALKORI®
(crizotinib), and IBRANCE® (palbociclib) while at Pfizer
Oncology.
Strengthened intellectual property estate
- In July 2023, Viracta received a Notice of Allowance from the
US Patent and Trademark Office on Viracta’s patent claims directed
to a next-generation formulation of nanatinostat. This Notice of
Allowance supports Viracta’s life-cycle management strategy, and
upon issuance, the claims will expire in October 2041.
Second Quarter 2023 Financial
Results
- Cash position –
Cash, cash equivalents, and short-term investments totaled
approximately $72.9 million as of June 30, 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 and subject to the discretion of the
lenders.
- Research and development
expenses – Research and development (R&D) expenses
were approximately $8.2 million and $15.8 million for the three and
six months ended June 30, 2023, respectively, compared to
approximately $6.3 million and $12.4 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 $8.9 million for the three and
six months ended June 30, 2023, respectively, compared to $4.2
million and $8.5 million for the same periods in 2022. The increase
in G&A expenses can be primarily attributed to an increase in
personnel-related costs.
- Net loss – Net
loss was approximately $12.5 million, or $0.32 per share, (basic
and diluted) for the quarter ended June 30, 2023, compared to a net
loss of $10.6 million, or $0.28 per share, (basic and diluted) for
the same period in 2022. Net loss was approximately $24.7 million,
or $0.64 per share, (basic and diluted) for the six months ended
June 30, 2023, compared to a net loss of $21.1 million, or $0.56
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 six 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
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 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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|
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(in
thousands) |
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|
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June 30, |
|
|
December 31, |
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|
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|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
72,867 |
|
|
$ |
91,043 |
|
|
|
|
|
|
|
|
Total
assets |
$ |
76,859 |
|
|
$ |
95,991 |
|
|
|
|
|
|
|
|
Total
liabilities |
$ |
36,077 |
|
|
$ |
34,888 |
|
|
|
|
|
|
|
|
Stockholders' equity |
$ |
40,782 |
|
|
$ |
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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|
|
|
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Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
8,197 |
|
|
$ |
6,324 |
|
|
$ |
15,804 |
|
|
$ |
12,420 |
|
|
General and administrative |
|
4,253 |
|
|
|
4,181 |
|
|
|
8,853 |
|
|
|
8,517 |
|
|
Total
operating expenses |
|
12,450 |
|
|
|
10,505 |
|
|
|
24,657 |
|
|
|
20,937 |
|
|
Loss from
operations |
|
(12,450 |
) |
|
|
(10,505 |
) |
|
|
(24,657 |
) |
|
|
(20,937 |
) |
|
Total other
expense |
|
(34 |
) |
|
|
(77 |
) |
|
|
(36 |
) |
|
|
(191 |
) |
|
Net
loss |
|
(12,484 |
) |
|
|
(10,582 |
) |
|
|
(24,693 |
) |
|
|
(21,128 |
) |
|
Unrealized
(loss) gain on short-term investments |
|
(28 |
) |
|
|
— |
|
|
|
63 |
|
|
|
— |
|
|
Comprehensive loss |
|
(12,512 |
) |
|
|
(10,582 |
) |
|
|
(24,630 |
) |
|
|
(21,128 |
) |
|
Net loss per
share, basic and diluted |
$ |
(0.32 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.56 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
38,560,376 |
|
|
|
37,599,244 |
|
|
|
38,509,887 |
|
|
|
37,567,734 |
|
|
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