Full Press Release Details
Viracta Therapeutics Reports Second Quarter 2021 Financial Results and Provides Clinical and Corporate
Initiated NAVAL-1, a global pivotal trial for the treatment of relapsed/refractory EBV-positive lymphoma
Received FDA clearance of IND application for a Phase 1b/2 trial in EBV-positive solid tumors
Strengthened management team with the appointment of Ayman Elguindy,
Ph.D., as Chief Scientific Officer
Cash and cash equivalents of approximately $122.7 million as of June 30, 2021
PR Newswire, San Diego, August 12, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting
virus-associated malignancies, today announced financial results for the second quarter of 2021 and provided clinical and corporate updates.
entered the second half of the year with strong momentum thanks to the completion of key milestones across our pipeline, said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. We believe Viracta is strongly-positioned
to advance our novel therapy for the treatment of EBV-positive cancers forward, with our pivotal NAVAL-1 trial now open for enrollment and the recent clearance of our
IND for EBV-positive solid tumors paving the way for a multicenter Phase 1b/2 trial. These two trials are targeting patient populations with a significant unmet medical need, and our expansion into solid
tumors could meaningfully broaden our addressable patient market.
Second Quarter 2021 and Recent Highlights
Anticipated 2021 Milestones
Second Quarter 2021 Financial Results
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 latent viral genes
which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in various subtypes of relapsed/refractory EBV+ lymphoma in multiple clinical trials, including a registration-enabling global, multicenter, open-label basket trial.
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 for EBV+ lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal
carcinoma, gastric carcinoma, and 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 and timeline for the ongoing and planned trials; the ability of
Viracta to support multiple NDA filings from the NAVAL-1 trial; Viracta s ability to expand the impact and broaden the reach of its therapeutic approach, the timing of the initiation of the solid tumor
trial and the updated date from the ongoing Phase 1b/2 trial; Viracta s cash projections and the sufficiency its cash and cash equivalents to fund operations into 2024; 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 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
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: | Company Contact: | |
| Joyce Allaire | Dan Chevallard | |
| LifeSci Advisors | Chief Operating Officer and Chief Financial Officer | |
| jallaire@lifesciadvisors.com | dchevallard@viracta.com | |
| (212) 915-2569 | (858) 771-4193 |
SOURCE Viracta Therapeutics, Inc.
Viracta Therapeutics, Inc.
Selected Balance Sheet Highlights
| June 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Cash and cash equivalents | $ | 122,721 | $ | 47,089 | ||||
| Total assets | $ | 128,679 | $ | 48,305 | ||||
| Total liabilities | $ | 11,582 | $ | 11,203 | ||||
| Stockholders equity | $ | 117,097 | $ | (46,200 | ) |
Viracta Therapeutics, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(in thousands except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,446 | $ | 3,361 | $ | 9,470 | $ | 6,807 | ||||||||
| Acquired in-process research and development | 84,478 | |||||||||||||||
| General and administrative | 3,871 | 879 | 7,711 | 1,890 | ||||||||||||
| Total operating expenses | 9,317 | 4,240 | 101,659 | 8,697 | ||||||||||||
| Gain on Royalty Purchase Agreement | 13,500 | |||||||||||||||
| Loss from operations | (9,317 | ) | (4,240 | ) | (88,159 | ) | (8,697 | ) | ||||||||
| Total other income (expense) | 147 | 4 | (242 | ) | 44 | |||||||||||
| Net loss and comprehensive loss | $ | (9,170 | ) | $ | (4,236 | ) | $ | (88,401 | ) | $ | (8,653 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (15.52 | ) | $ | (3.37 | ) | $ | (32.13 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 37,221,407 | 273,056 | 26,255,992 | 269,325 |
Viracta Therapeutics, Inc.
Reconciliation of GAAP Loss from Operations to Adjusted Loss from Operations
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Loss from operations | $ | (9,317 | ) | $ | (4,240 | ) | $ | (88,159 | ) | $ | (8,697 | ) | ||||
| Less: Acquired in-process research and development | 84,478 | |||||||||||||||
| Adjusted loss from operations | $ | (9,317 | ) | $ | (4,240 | ) | $ | (3,681 | ) | $ | (8,697 | ) |