On November 2, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported financial results for the third quarter of 2022 and highlighted recent achievements and developments (Press release, Oncorus, NOV 2, 2022, View Source [SID1234622808]).

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"We continue to focus on our differentiated portfolio of intratumorally and intravenously administered viral immunotherapies across our two platforms. We’ve been tracking well against our set milestones for this year and are well positioned for further advancement across our portfolio," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We’ve bolstered our position within the viral immunotherapy landscape with the recent relocation of our company to our facility in Andover, Massachusetts, bringing research, process development and GMP-compliant manufacturing under one roof. With the completion of Andover, we are realizing our goal of becoming a fully integrated viral immunotherapies company. We are preparing to announce further data from our ongoing clinical trial of ONCR-177 in the fourth quarter of this year. In parallel, we are rapidly progressing our vRNA/LNP immunotherapy platform, further supported by the recent publication of promising preclinical results in Nature Communications. We expect an IND submission for our lead vRNA/LNP product candidate, ONCR-021, in mid-2023."

Third Quarter 2022 and Recent Business Highlights

On track to report combination data and additional monotherapy data for ONCR-177 in the fourth quarter of 2022. Oncorus continues to dose patients in its Phase 1 open-label, multi-center clinical trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The company expects to report initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data in the fourth quarter of 2022.
Preclinical results featured in Nature Communications supporting intravenously administered self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform. In October 2022, Oncorus published preclinical data in Nature Communications highlighting the potential of its vRNA/LNP immunotherapy platform as a novel approach to treating cancer through repeat intravenous (IV) administration. The data demonstrate vRNA/LNP delivery and selective replication, virus assembly, spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of virus neutralizing antibodies in the bloodstream. Oncorus remains on track to submit an investigational new drug application (IND) for the company’s lead product candidate from this platform, ONCR-021, in mid-2023.
Completed construction phase of Good Manufacturing Practice (GMP) -compliant manufacturing facility in Andover, Massachusetts. Oncorus built its state-of-the-art, 105,000 square foot process development and GMP-compliant clinical manufacturing facility as a comprehensive solution for its Chemistry, Manufacturing and Controls (CMC) development needs, allowing for the manufacture, quality control and supply of clinical-grade viral immunotherapies for its IND-enabling and clinical studies. The company also relocated all personnel and corporate activities to the facility, enabling collaboration among company personnel and enhanced efficiency.
Third Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $81.5 million as of September 30, 2022 compared to $123.9 million as of December 31, 2021.
Research and development expenses for the quarter ended September 30, 2022 were $14.1 million compared to $11.3 million for the corresponding quarter in 2021. The increase was primarily attributable to increased headcount, which drove higher employee compensation and stock-based compensation, increased development costs related to the company’s nominated candidates, as well as increased rent expense related to the company’s manufacturing facility.
General and administrative expenses for the quarter ended September 30, 2022 were $5.2 million compared to $5.4 million for the corresponding quarter in 2021. The slight decrease was primarily attributable to lower recruiting and consulting costs.
Net loss for the quarter ended September 30, 2022 was $19.6 million, or $0.76 per share, as compared to a net loss of $16.7 million, or $0.65 per share for the corresponding quarter in 2021.
Financial Guidance

Oncorus expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.