Exhibit 99.1
Oncorus Reports Third Quarter 2021 Financial Results and Provides Business Updates
CAMBRIDGE, Mass., November 3, 2021 – Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today reported third quarter 2021 financial results and highlighted recent achievements and developments.
“We continue to make important progress advancing our broad portfolio of next-generation viral immunotherapies and creating a state-of-the-art process development and manufacturing infrastructure to support our planned future development activities and growth,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. “Our Phase 1 clinical trial of ONCR-177 continues to enroll patients, and we are excited to begin sharing data from this trial at SITC next week during a poster presentation beginning on November 12th. Across our oHSV and Synthetic vRNA Immunotherapy platforms we have multiple preclinical efforts underway as we advance our next programs toward the clinic. In addition, we are thrilled to report that the first phase of our manufacturing facility has been completed, with Oncorus team members now working onsite, overseeing process development activities.”
Dr. Ashburn continued, “The breadth of activities we have underway is a testament to the tremendous competence and capabilities of our team. We continue to execute on our goal of building the leading viral immunotherapies company, based on world-class science, pipeline breadth, and an unwavering commitment to cancer patients.”
Third Quarter 2021 and Recent Highlights
Oncorus is currently initiating GLP safety and tolerability studies for ONCR-021 and anticipates submitting an IND for this program in the first half of 2023. The company is also conducting preliminary non-GLP safety and tolerability studies for ONCR-788 and is not yet providing guidance on timing of an IND submission for this program. Oncorus plans to investigate its novel Synthetic vRNA immunotherapies in multiple histologies, including cancers of the lung, both as monotherapy and in combination with immune checkpoint inhibitors and possibly other cancer treatments.
Oncorus will present a poster titled, “ONCR-GBM: A Novel, Armed Oncolytic HSV-1 Vector Engineered for Efficacy and Safety in Glioblastoma” (Poster #10226), at IOVC 2021, which will take place November 5 – 7 in Sedona, Arizona and virtually. Part of the conference’s Virtual Poster Session, Oncorus’ e-poster will describe the design and evaluation of multiple features that will be incorporated into the ONCR-GBM program, including robust anti-tumor activity observed with IL-12 and a proprietary PD-1 antagonist nanobody. Link to the meeting website here.
Third Quarter Financial Results
Financial Guidance
Based upon its current operating plans and cash and cash equivalents, 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 oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform.
Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead oHSV 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 Synthetic 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 Synthetic 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 the clinical development of ONCR-177, including expectations regarding timing for reporting data from 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’ oHSV Platform; Oncorus’ expectations regarding its other potential product candidates, including the timing of the submission of an IND for its second oHSV Platform program, ONCR-GBM, and the design thereof; the preclinical and clinical development of ONCR-021 and ONCR-788, including expectations regarding timing for submitting INDs, as well as the product candidates’ therapeutic potential and clinical benefits and the utility and potential of Oncorus’ Synthetic vRNA Immunotherapy Platform; Oncorus’ belief that it is creating the first-ever Synthetic vRNA immunotherapy; expectations regarding manufacturing capabilities including the buildout timeline of Oncorus’ viral immunotherapy clinical manufacturing facility and readiness for GMP production; and Oncorus’ belief that its current cash 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 and ONCR-788 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, 2020, filed with the Securities and Exchange
Commission on March 10, 2021, 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.
Media Contact:
Liz Melone
liz@scientpr.com
Investor Contact:
Stern Investor Relations
Julie Seidel
Julie.seidel@sternir.com
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
Unaudited
|
| Three Months Ended |
|
| Nine Months Ended |
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
| ||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
| $ | 11,299 |
|
| $ | 6,927 |
|
| $ | 30,406 |
|
| $ | 19,560 |
|
General and administrative |
|
| 5,440 |
|
|
| 1,973 |
|
|
| 14,550 |
|
|
| 6,032 |
|
Total operating expenses |
|
| 16,739 |
|
|
| 8,900 |
|
|
| 44,956 |
|
|
| 25,592 |
|
Loss from operations |
|
| (16,739 | ) |
|
| (8,900 | ) |
|
| (44,956 | ) |
|
| (25,592 | ) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Change in fair value of Series B tranche rights |
|
| — |
|
|
| (10,631 | ) |
|
| — |
|
| $ | (11,256 | ) |
Other expense |
|
| — |
|
|
| (2 | ) |
|
| (1 | ) |
|
| (22 | ) |
Interest income |
|
| 11 |
|
|
| 2 |
|
|
| 38 |
|
|
| 138 |
|
Total other income (expense), net |
|
| 11 |
|
|
| (10,631 | ) |
|
| 37 |
|
|
| (11,140 | ) |
Net loss and comprehensive loss |
| $ | (16,728 | ) |
| $ | (19,531 | ) |
| $ | (44,919 | ) |
| $ | (36,732 | ) |
Accretion of discount and dividends on redeemable convertible preferred stock |
|
| — |
|
|
| (2,848 | ) |
|
| — |
|
|
| (8,298 | ) |
Net loss attributable to common stockholders |
| $ | (16,728 | ) |
| $ | (22,379 | ) |
| $ | (44,919 | ) |
| $ | (45,030 | ) |
Net loss per share - basic and diluted |
| $ | (0.65 | ) |
| $ | (21.73 | ) |
| $ | (1.79 | ) |
| $ | (44.58 | ) |
Weighted-average number of common shares - basic and diluted |
|
| 25,748 |
|
|
| 1,030 |
|
|
| 25,153 |
|
|
| 1,010 |
|
Oncorus, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
|
| September 30, |
|
| December 31, |
| ||
Cash and cash equivalents |
| $ | 145,603 |
|
| $ | 130,305 |
|
Working capital (1) |
|
| 135,376 |
|
|
| 127,407 |
|
Right-of-use asset |
|
| 37,428 |
|
|
| 41,372 |
|
Total assets |
|
| 202,727 |
|
|
| 182,263 |
|
Long term lease liability |
|
| 42,329 |
|
|
| 41,615 |
|
Total liabilities |
|
| 54,885 |
|
|
| 47,599 |
|
Total stockholders' equity |
|
| 147,842 |
|
|
| 134,664 |
|
(1) Working capital is defined as current assets less current liabilities