Oncorus Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates
CAMBRIDGE, Mass., March 9, 2022 – Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today reported fourth quarter and full year 2021 financial results and highlighted recent achievements and developments.
“In 2021, Oncorus made meaningful progress advancing our pipeline of next-generation, systemically active viral immunotherapies. With a broad range of activities across both our innovative HSV and selectively self-amplifying vRNA/LNP platforms, we are well-positioned to execute on multiple clinical and preclinical catalysts this year as we build out our differentiated portfolio of intratumorally and intravenously administered viral immunotherapies,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. “We remain on track to report multiple clinical-stage milestones this year, with both additional ONCR-177 data from the surface lesion monotherapy expansion and the initial combination expansion data with KEYTRUDA expected in the second half of 2022. We also continue to progress our earlier stage programs, with ONCR-021 advancing into IND-enabling studies, while we simultaneously build out our Andover manufacturing facility to enable expansion of our portfolio.”
Fourth Quarter 2021 and Recent Business Highlights
Fourth Quarter 2021 Financial Results
Financial Guidance
Based upon its current operating plans and cash and cash equivalents and investments, Oncorus expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.
About Oncorus
At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our Herpes Simplex Virus (HSV) Platform and selectively self-amplifying viral RNA (vRNA)/ lipid nanoparticle (LNP) Immunotherapy Platform.
Designed to deliver next-generation viral immunotherapy impact, our HSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead HSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the
therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which could limit systemic toxicities. Our pioneering selectively self-amplifying vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA and oncolytic virus-based modalities designed to realize the potential of RNA medicines for cancer. Our lead IV-administered selectively self-amplifying vRNA Immunotherapy clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.
Please visit www.oncorus.com to learn more.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Oncorus’ ability to execute on multiple clinical and preclinical catalysts in 2022; the clinical development of ONCR-177, including expectations regarding timing for reporting additional data from the monotherapy expansion and the combination expansion arms of the ongoing Phase 1 clinical trial, as well as the product candidate’s therapeutic potential and clinical benefits and the utility and potential of Oncorus’ HSV Platform; the preclinical and clinical development of ONCR-021 and ONCR-788, including expectations regarding timing for submitting an IND for ONCR-021, as well as the product candidates’ therapeutic potential and clinical benefits and the utility and potential of Oncorus’ selectively self-amplifying vRNA Immunotherapy Platform; expectations regarding manufacturing capabilities including the buildout timeline of Oncorus’ clinical manufacturing facility; and Oncorus’ belief that its current cash and investment resources will be sufficient to fund its operations and capital expenditure requirements into late 2023. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus’ ability to successfully demonstrate the safety, tolerability and efficacy of ONCR-177, ONCR-021, ONCR-788 and ONCR-GBM and obtain regulatory approval thereof; Oncorus’ ability to obtain the requisite components for its product candidates manufactured in accordance with regulatory requirements; the expansion of Oncorus’ in-house manufacturing capabilities; the adequacy of Oncorus’ existing capital resources and availability of financing on commercially reasonable terms; the accuracy of the Oncorus’ estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and Oncorus’ ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus’ Annual Report on Form 10-K for the year ended December 31, 2021, to be filed with the Securities and Exchange Commission on or about March 9, 2022, as well as discussions of potential risks, uncertainties,
and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the “SEC filings” page of the Investors section of Oncorus’ website at http://investors.oncorus.com. Any forward- looking statements represent Oncorus’ views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact:
Stern Investor Relations
Julie Seidel
Julie.seidel@sternir.com
Oncorus, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
|
| Three Months Ended |
|
| Twelve Months Ended |
| ||||||||||
|
| December 31, |
|
| December 31, |
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
| ||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
| $ | 14,276 |
|
| $ | 7,593 |
|
| $ | 44,682 |
|
| $ | 27,153 |
|
General and administrative |
|
| 5,586 |
|
|
| 3,968 |
|
|
| 20,136 |
|
|
| 10,000 |
|
Total operating expenses |
|
| 19,862 |
|
|
| 11,561 |
|
|
| 64,818 |
|
|
| 37,153 |
|
Loss from operations |
|
| (19,862 | ) |
|
| (11,561 | ) |
|
| (64,818 | ) |
|
| (37,153 | ) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Change in fair value of Series B tranche rights |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (11,256 | ) |
Other expense |
|
| (8 | ) |
|
| (11 | ) |
|
| (9 | ) |
|
| (33 | ) |
Interest income |
|
| 27 |
|
|
| 5 |
|
|
| 65 |
|
|
| 143 |
|
Total other income (expense), net |
|
| 19 |
|
|
| (6 | ) |
|
| 56 |
|
|
| (11,146 | ) |
Net loss |
| $ | (19,843 | ) |
| $ | (11,567 | ) |
| $ | (64,762 | ) |
| $ | (48,299 | ) |
Accretion of discount and dividends on redeemable |
|
| — |
|
|
| (229 | ) |
|
| — |
|
|
| (8,527 | ) |
Net loss attributable to common stockholders |
| $ | (19,843 | ) |
| $ | (11,796 | ) |
| $ | (64,762 | ) |
| $ | (56,826 | ) |
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net unrealized loss on investments |
|
| (14 | ) |
|
| — |
|
|
| (14 | ) |
|
| — |
|
Comprehensive loss |
| $ | (19,857 | ) |
| $ | (11,567 | ) |
| $ | (64,776 | ) |
| $ | (48,299 | ) |
Net loss per share - basic and diluted |
| $ | (0.77 | ) |
| $ | (0.56 | ) |
| $ | (2.56 | ) |
| $ | (9.35 | ) |
Weighted-average number of common shares - |
|
| 25,814 |
|
|
| 21,126 |
|
|
| 25,320 |
|
|
| 6,080 |
|
Oncorus, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
|
| December 31, 2021 |
|
| December 31, 2020 |
| ||
Cash and cash equivalents |
| $ | 100,752 |
|
| $ | 130,305 |
|
Investments |
|
| 23,173 |
|
|
| — |
|
Working capital (1) |
|
| 108,136 |
|
|
| 127,407 |
|
Right-of-use asset |
|
| 45,218 |
|
|
| 41,372 |
|
Total assets |
|
| 201,587 |
|
|
| 182,263 |
|
Long term lease liability |
|
| 50,388 |
|
|
| 41,615 |
|
Total liabilities |
|
| 71,565 |
|
|
| 47,599 |
|
Total stockholders' equity |
| $ | 130,022 |
|
| $ | 134,664 |
|
(1) Working capital is defined as current assets less current liabilities