SAN DIEGO, Nov. 10, 2021 /PRNewswire/ -- Viracta
Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company
targeting virus-associated malignancies, today announced financial
results for the third quarter of 2021 and provided an update on
recent corporate activities.
"Over the past months we achieved key milestones that have
furthered the development of Nana-val and positioned us to broaden
our addressable patient population," said Ivor Royston, M.D., President and Chief
Executive Officer of Viracta. "We expanded our clinical trial
pipeline with the initiation of our EBV-positive solid tumor trial
and reacquired all rights to Nana-val in China, a strategically important territory
given the high prevalence of EBV-associated cancers in Asia. Looking ahead, we expect continued
progress in our solid tumor trial, as well as continued global
expansion of our pivotal NAVAL-1 trial in EBV-positive lymphoma. In
addition, we are excited about our multiple ASH presentations that
will feature final results from our Phase 1b/2 EBV-positive lymphoma trial and preclinical
findings on vecabrutinib, our reversible inhibitor of Bruton's
tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK),
which we are exploring for potential use in combination with CAR
T-cell therapy."
Dan Chevallard, Chief Operating
Officer and Chief Financial Officer of Viracta, added, "Viracta
remains in a strong financial position as we move toward the end of
year. We ended the third quarter with approximately $111.0 million in cash and have reiterated our
plan to end the year with over $100.0
million in cash. Importantly, we have now secured access to
significant additional and undrawn non-dilutive and available
capital through our recently expanded credit facility. We believe
our financial strength positions us well to deliver on our
development and strategic objectives into 2024."
Third Quarter 2021 and Recent Highlights
Clinical
- Continued the global expansion of pivotal NAVAL-1 trial;
multiple U.S. and international sites now open for enrollment.
NAVAL-1 (Nanatinostat in Combination with
Valganciclovir) is a global, multicenter, open-label Phase 2
basket trial. The trial, which will include patients with multiple
subtypes of R/R EBV+ lymphoma, is designed to evaluate
the anti-tumor activity of Nana-val and is designed to enroll
approximately 140 patients. The primary endpoint of the trial is
objective tumor response rate as assessed by an independent review
committee. If successful, the Company believes this trial could
potentially support multiple new drug application (NDA) filings
across various EBV+ lymphoma subtypes. The study employs
a Simon two-stage design where a limited number of patients are
enrolled into each cohort in Stage 1 and, if a pre-specified
activity threshold is reached, additional patients will be enrolled
in Stage 2. During Stage 2, the Company anticipates discussing the
preliminary results with the U.S. Food and Drug Administration
(FDA) and may amend the protocol to include additional patients as
necessary to enable registration. The Company anticipates providing
an update on the initial cohort(s) that have expanded into Stage 2
in the second half of 2022.
- Initiated a Phase 1b/2 trial
of Nana-val in patients with EBV+ recurrent or
metastatic nasopharyngeal carcinoma (RM-NPC) and other
EBV+ solid tumors. This Phase 1b/2 open-label multicenter trial is evaluating
Nana-val alone and in combination with pembrolizumab in patients
with advanced EBV+ solid tumors. The Phase 1b dose escalation part will evaluate safety and
determine the recommended Phase 2 dose (RP2D) of Nana-val in
patients with EBV+ RM-NPC. In Phase 2, up to 60 patients
with EBV+ RM-NPC will be randomized to receive Nana-val
at the RP2D with or without pembrolizumab to evaluate safety and
preliminary efficacy. Additionally, patients with other
EBV+ solid tumors will be enrolled to receive Nana-val
at the RP2D in a Phase 1b dose
expansion cohort. The Company anticipates providing preliminary
clinical data from the trial in 2022.
- Announced an upcoming oral presentation at the 2021 ASH
Annual Meeting featuring final results from VT3996-201, the
Phase 1b/2 trial of Nana-val in R/R
EBV+ lymphoma. Data indicate that Nana-val was well
tolerated and shows promising efficacy in patients with R/R
EBV+ lymphoma. The presentation's corresponding abstract
is currently available on the ASH website.
Preclinical
- Announced upcoming oral and poster presentations at the 2021
ASH Annual Meeting featuring preclinical data on vecabrutinib, a
reversible inhibitor of BTK and ITK. Data to be featured in the
oral presentation demonstrate that using vecabrutinib is a novel
strategy to modulate CD19-targeted chimeric antigen receptor (CAR)
T-cell functions by increasing their efficacy, and decreasing their
toxicity, while maintaining their proliferative potential. The
poster presentation will feature data showing that vecabrutinib
treatment demonstrated efficacy and beneficially regulated B cell
and T cell immune subsets in a preclinical murine model of
sclerodermatous chronic graft-versus-host disease. The
presentations' corresponding abstracts are currently available on
the ASH website.
Corporate
- Reacquired the exclusive development and commercialization
rights for Nana-val in China.
Following the reacquisition of the exclusive rights to develop and
commercialize Nana-val in the People's
Republic of China from Shenzhen Salubris Pharmaceuticals
Co., Ltd., Viracta now controls global rights to its all-oral
combination therapy.
- Secured expanded $50 million
credit facility from Silicon Valley Bank (SVB) and Oxford
Finance. The credit facility replaces Viracta's prior
$15 million loan and security
agreement with SVB and provides the Company with the option to
obtain additional non-dilutive funding at a single-digit cost of
capital. Through this expanded credit facility, the Company's
existing $5 million debt balance was
refinanced. The remaining $45.0
million is available and the Company is under no obligation
to draw funds in the future.
- Appointed Flavia Borellini,
Ph.D., and Jane F. Barlow, M.D.,
MPH, MBA, as independent members to its Board of Directors. Dr.
Borellini has more than 25 years of executive management experience
in the pharmaceutical and biotechnology industry, with a particular
focus on the development of targeted oncology drugs. As the former
Chief Executive Officer of Acerta Pharma, she oversaw the
development and approval of the BTK inhibitor Calquence®
(acalabrutinib). Dr. Barlow is currently the Chief Executive
Officer of Jane Barlow &
Associates, LLC and has over 25 years of leadership experience in
driving cost-effective medical, diagnostic and pharmaceutical
strategies.
- Expanded Scientific Advisory Board with the addition of
Dr. Shannon Kenney. Dr.
Kenney is the Wattawa Bascom Professor in Cancer Research at the
University of Wisconsin-Madison School of
Medicine and Public Health, in the Departments of Oncology
and Medicine. She obtained her B.A. and MD degrees from
Yale University and was a postdoctoral
research fellow at the NIAID and the Lineberger Comprehensive
Cancer Center. Dr. Kenney's research is focused on understanding
the molecular regulation and pathogenesis of EBV in both epithelial
cells and B cells, including viral gene regulation, host-pathogen
interactions, and virally-induced transformation.
Anticipated 2021 Milestones and Key Upcoming Events
- Final results from the Phase 1b/2
trial of Nana-val in R/R EBV+ lymphoma (VT3996-201) will
be presented in an oral presentation at the 2021 ASH Annual Meeting
in December 2021
- Results from preclinical studies of vecabrutinib will be
presented in both an oral and poster presentations at the 2021 ASH
Annual Meeting in December 2021
Third Quarter 2021 Financial Results
- Cash position – Cash and cash equivalents totaled
approximately $111.0 million as of
September 30, 2021. Viracta expects
to end 2021 with greater than $100.0
million in cash and cash equivalents, which it anticipates
will be sufficient to fund its operations into 2024, excluding any
additional borrowings under the $50.0
million credit facility.
- Research and development expenses – Research and
development expenses were $7.1
million and $16.6 million for
the three and nine-months ending September
30, 2021, respectively, compared to $3.1 million and $9.9
million for the same periods in 2020. The increase was
primarily due to costs associated with the initiation of the
NAVAL-1 and solid tumor trials as well as an increase in headcount
and non-cash share-based compensation.
- Purchased and acquired in-process research and
development – Purchased and acquired in-process research and
development expenses of $4.0 million
and $88.5 million were recorded for
the three and nine-months ending September
30, 2021. The expenses were related to the $4.0 million payment associated with the
termination of the collaboration and license agreement with
Shenzhen Salubris Pharmaceutical Co. Ltd. and non-cash and
non-recurring costs of $84.5 million
related to the write-off of in-process research and development
acquired in the merger with Sunesis Pharmaceuticals.
- General and administrative expenses – General and
administrative expenses were $3.7
million and $11.4 million for
the three and nine-months ending September
30, 2021, respectively, compared to $0.9 million and $2.8
million for the same periods in 2020. The increase was
largely due to incremental costs associated with being a publicly
traded company, including legal fees, audit fees, consulting
expenses, filing fees and increased directors and officer's
insurance costs, in addition to an increase in non-cash share-based
compensation.
- Gain on Royalty Purchase Agreement – Gain on Royalty
Purchase Agreement for the nine-months ending September 30, 2021, was associated with upfront
proceeds of $13.5 million received in
connection with the multi-license milestone and royalty
monetization transaction with XOMA Corporation in March 2021.
- Adjusted loss from operations – Adjusted loss from
operations for the nine-months ended September 30, 2021, excluding the non-recurring
operating expenses associated with the write-off of in-process
research and development acquired in the merger and the termination
agreement with Salubris Pharmaceutical Co. Ltd. (a non-GAAP
measure) was $14.5 million, compared
to a loss from operations of $103.0
million. There is not a comparative adjustment to loss from
operations for the same period in 2020.
- Net loss – Net loss was $14.9
million, or $0.40 per share
(basic and diluted) for the quarter ended September 30, 2021, compared to a net loss of
$4.1 million, or $14.22 per share for the same period in 2020. Net
loss was $103.3 million, or
$3.44 per share (basic and diluted)
for the nine months ended September 30,
2021, compared to a net loss of $12.7
million, or $46.27 per share
(basic and diluted) for the same period in 2020.
About Nanatinostat
Nanatinostat (VRx-3996) is an orally available histone
deacetylase (HDAC) inhibitor being developed by Viracta.
Nanatinostat is selective for specific isoforms of Class I HDACs,
which is key to inducing viral genes that are epigenetically
silenced in EBV-associated malignancies. Nana-val (nanatinostat and
valganciclovir) is being investigated in multiple subtypes of
relapsed/refractory EBV+ lymphoma and in advanced
EBV+ solid tumors in three clinical trials, one of which
is a registration-enabling global, multicenter, open-label Phase 2
basket trial in relapsed/refractory EBV+ lymphoma
(NAVAL-1).
About Vecabrutinib
Vecabrutinib is a selective, reversible, non-covalent inhibitor
of Bruton's tyrosine kinase (BTK) and interleukin-2-inducible
kinase (ITK). Vecabrutinib is being studied as a potential enhancer
of efficacy and safety of CAR T-cell therapy.
About Viracta Therapeutics, Inc.
Viracta is a precision oncology company targeting
virus-associated malignancies. Viracta's proprietary
investigational drug, nanatinostat, is currently being evaluated in
combination with the antiviral agent valganciclovir as an oral
combination therapy in two Phase 2 clinical trials for EBV-positive
(EBV+) lymphoma and one Phase 1b/2 trial in patients with EBV+
nasopharyngeal carcinoma and other EBV+ solid tumors.
Viracta is also pursuing the application of its inducible synthetic
lethality approach in other virus-related cancers.
For additional information please visit www.viracta.com.
Forward-Looking Statements
This 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
trials; the expected data from the EBV+ solid tumor
trial in 2022; Viracta's plans to meet with the FDA to discuss
preliminary results from the NAVAL-1 trial and amending the NAVAL-1
protocol to add patients as necessary to enable registration;
Viracta's plans to provide updates on NAVAL-1 in the second half of
2022; the significance of Viracta's data being featured at the 2021
ASH Annual Meeting; Viracta's cash projections and the sufficiency
its cash and cash equivalents to fund operations into 2024; the
future availability of capital under Viracta's credit facility; the
expected 2021 milestones and key upcoming events and their
significance; and other statements that are not historical
facts. 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 supplying 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.
These risks and uncertainties may be amplified by the 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 Barreto
Head of Investor Relations & Corporate Communication
Viracta Therapeutics, Inc.
abarreto@viracta.com
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SOURCE Viracta