On November 3, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported third quarter 2021 financial results and highlighted recent achievements and developments (Press release, Oncorus, NOV 3, 2021, View Source [SID1234594255]).

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"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 (Free SITC Whitepaper) 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

Initial data to be presented for ongoing Phase 1 clinical trial of ONCR-177 at SITC (Free SITC Whitepaper) 2021, taking place November 12 – 14 in Washington, DC and virtually. Oncorus continues to enroll patients across 11 sites in the United States and Canada in a Phase 1 clinical trial of ONCR-177, an intratumorally (iTu) administered oHSV viral immunotherapy, being developed for multiple solid tumor indications. The Phase 1 open-label, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. This presentation at SITC (Free SITC Whitepaper) will mark Oncorus’ first reporting of human data from its oHSV platform.
Continued to progress first Synthetic vRNA immunotherapy clinical candidates, ONCR-021 and ONCR-788. As disclosed earlier this year, ONCR-021 and ONCR-788 employ Oncorus’ pioneering IV-administered approach of encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in lipid nanoparticles (LNPs), creating, to the company’s knowledge, the first-ever Synthetic vRNA immunotherapy. ONCR-021 encodes an optimized strain of CVA21 (Coxsackievirus A21); ONCR-788 encodes a modified version of SVV (Seneca Valley Virus, or SVV). CVA21 and SVV both have extensive clinical experience and favorable safety profiles when administered intravenously. Oncorus’ novel Synthetic vRNA approach holds the potential for IV administration while avoiding the challenge of neutralizing antibodies seen in previous approaches with IV-administered OVs. (Learn more about Oncorus’ novel Synthetic vRNA Immunotherapy approach.)

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.
Upcoming preclinical presentation on ONCR-GBM at the International Oncolytic Virus Conference (IOVC) 2021. Leveraging its oHSV platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). The company is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and to select a rational combination of payloads intended to address both the cancer itself and the specific drivers of immune suppression in the brain. Oncorus plans to submit an IND for ONCR-GBM in the second half of 2023.

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.
Completed first phase of Process Development and Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility buildout. Oncorus has completed the first phase of its state-of-the-art, 88,000 square foot process development and GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. Oncorus is building out the expansive facility to provide a comprehensive solution for its Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality control and supply of clinical-grade viral immunotherapies for IND-enabling and clinical studies. Process development and GMP readiness activities are now underway at the site. Oncorus anticipates the buildout to be completed and the site to be fully operational, including GMP multi-product manufacturing capabilities, in the first half of 2023.
Third Quarter Financial Results

Cash and cash equivalents were $145.6 million as of September 30, 2021 compared to $130.3 million as of December 31, 2020.
Research and development expenses for the quarter ended September 30, 2021 were $11.3 million compared to $6.9 million for the corresponding quarter in 2020. The increase in research and development expenses was mainly attributable to increased employee compensation costs, which was driven by increased headcount and increased stock-based compensation, increased rent expense related to the company’s new manufacturing facility and increased development costs related to the company’s nominated candidates.
General and administrative expenses for the quarter ended September 30, 2021 were $5.4 million compared to $2.0 million for the corresponding quarter in 2020. The increase in general and administrative expenses was primarily attributable to increases in employee compensation costs, including higher stock-based compensation, increased headcount and increased salary and related expenses. General and administrative expenses also increased due to higher insurance expense and professional and consultant expenses related to operating as a public company.
Other income (expense), net, for the quarter ended September 30, 2021 was income of $0.01 million compared to an expense of $10.6 million for the quarter ended September 30, 2020. The expense for the quarter ended September 30, 2020 included a non-cash charge of $10.6 million related to an increase in the fair market value of the company’s Series B preferred stock tranche rights liability that was settled in September 2020.
Net loss attributable to common stockholders for the quarter ended September 30, 2021 was $16.7 million, or $0.65 per share, as compared to a net loss attributable to common stockholders of $22.4 million, or $21.73 per share for the same quarter in 2020. The share and net loss per share amounts in the third quarter of 2021 include the impact of Oncorus’ IPO, which closed in October 2020, including the conversion of outstanding preferred stock into approximately 15.0 million shares of common stock.
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.