11/10/2021 | Press release | Distributed by Public on 11/10/2021 15:07
Viracta Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
Announced that final results of Phase 1b/2 trial of nanatinostat and valganciclovir (Nana-val) in relapsed/refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma were selected for an oral presentation at
the 2021 American Society of Hematology (ASH) Annual Meeting
Continued the global expansion of pivotal NAVAL-1 trial of Nana-val in R/R EBV+ lymphoma; multiple U.S. and international sites now open for enrollment
Initiated Phase 1b/2 trial of Nana-val in patients with EBV+ solid tumors; preliminary data anticipated in 2022
Announced that preclinical data on vecabrutinib was selected for oral and poster presentations at ASH
Secured expanded $50 million credit facility from Silicon Valley Bank and Oxford Finance
Cash and cash equivalents of approximately $111.0 million as of September 30, 2021
PR Newswire, San Diego, November 10, 2021 - 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
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Preclinical
Corporate
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Anticipated 2021 Milestones and Key Upcoming Events
Third Quarter 2021 Financial Results
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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.
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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.
SOURCE Viracta Therapeutics, Inc.
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Viracta Therapeutics, Inc. |
|||||
Selected Balance Sheet Highlights |
|||||
(in thousands) |
|||||
Septemeber 30, |
December 31, |
||||
2021 |
2020 |
||||
(Unaudited) |
|||||
Cash and cash equivalents |
$ |
110,983 |
$ |
47,089 |
|
Total assets |
$ |
116,540 |
$ |
48,305 |
|
Total liabilities |
$ |
12,565 |
$ |
11,203 |
|
Stockholders' equity (deficit) |
$ |
103,975 |
$ |
(46,200 |
) |
Viracta Therapeutics, Inc. |
||||||||||||
Condensed Consolidated Statement of Operations and Comprehensive Loss |
||||||||||||
(in thousands except share and per share data) |
||||||||||||
(Unaudited) |
||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||
September 30, |
September 30, |
|||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||
Operating expenses: |
||||||||||||
Research and development |
$ |
7,088 |
$ |
3,105 |
$ |
16,558 |
$ |
9,912 |
||||
Purchased and acquired in-process research |
4,000 |
- |
88,478 |
- |
||||||||
General and administrative |
3,711 |
887 |
11,422 |
2,777 |
||||||||
Total operating expenses |
14,799 |
3,992 |
116,458 |
12,689 |
||||||||
Gain on Royalty Purchase Agreement |
- |
- |
13,500 |
- |
||||||||
Loss from operations |
(14,799 |
) |
(3,992 |
) |
(102,958 |
) |
(12,689 |
) |
||||
Total other expense |
(115 |
) |
(87 |
) |
(357 |
) |
(43 |
) |
||||
Net loss and comprehensive loss |
$ |
(14,914 |
) |
$ |
(4,079 |
) |
$ |
(103,315 |
) |
$ |
(12,732 |
) |
Net loss per share, basic and diluted |
$ |
(0.40 |
) |
$ |
(14.22 |
) |
$ |
(3.44 |
) |
$ |
(46.27 |
) |
Weighted-average common shares |
37,353,418 |
286,833 |
29,995,784 |
275,204 |
Viracta Therapeutics, Inc. |
||||||||||||
Reconciliation of GAAP Loss from Operations to Adjusted Income (Loss) from Operations |
||||||||||||
(in thousands) |
||||||||||||
(Unaudited) |
||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||
September 30, |
September 30, |
|||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||
Loss from operations |
$ |
(14,799 |
) |
$ |
(3,992 |
) |
$ |
(102,958 |
) |
$ |
(12,689 |
) |
Less: Purchased and acquired in-process research and development |
4,000 |
- |
88,478 |
- |
||||||||
Adjusted loss from operations |
$ |
(10,799 |
) |
$ |
(3,992 |
) |
$ |
(14,480 |
) |
$ |
(12,689 |
) |
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