On March 9, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported fourth quarter and full year 2021 financial results and highlighted recent achievements and developments (Press release, Oncorus, MAR 9, 2022, View Source [SID1234609748]).

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"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

Presented initial data from ongoing Phase 1 clinical trial of ONCR-177 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. In November 2021, Oncorus presented initial safety, tolerability, immune activation and clinical response data from its ongoing Phase 1 open-label, multi-center, dose escalation and expansion clinical trial of ONCR-177, an intratumorally (iTu) administered Herpes Simplex Virus (HSV) viral immunotherapy, being developed for multiple solid tumor indications. In the fully enrolled and completed surface lesion dose escalation part of the Phase 1 study, ONCR-177 was well tolerated with no dose-limiting toxicities. In addition, three of eight evaluable patients at the Recommended Phase 2 Dose (RP2D) across multiple indications (cutaneous melanoma, squamous cell carcinoma of the head and neck and mucosal melanoma) experienced clinical benefit after two doses of ONCR-177. The Phase 1 presentation at SITC (Free SITC Whitepaper) marked Oncorus’ first reporting of human data from its HSV platform.

On track to report additional ONCR-177 monotherapy and combination data in 2022. The Phase 1 open-label, multi-center, 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. The Company has completed enrollment in the dose expansion portion of the trial and continues to enroll patients in the combination cohort. Future data readouts are expected in the second half of 2022 and will include both additional surface lesion monotherapy expansion data for ONCR-177 and initial surface lesion combination expansion data for ONCR-177 administered with KEYTRUDA.

Signed exclusive licensing agreement with Gaeta Therapeutics for use of locally delivered Interleukin-12 (IL-12) via oncolytic viral expression in combination with immune checkpoint inhibitors. In November 2021, Oncorus signed an exclusive licensing agreement with Gaeta Therapeutics for the use of locally delivered IL-12 via oncolytic viral expression in combination with immune checkpoint inhibitors, including CTLA-4, PD-1 or PD-L1 checkpoint blockade.

Presented preclinical data on ONCR-GBM at the International Oncolytic Virus Conference (IOVC) 2021. In November 2021, Oncorus presented a preclinical poster describing 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. Leveraging its HSV 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.

Selectively self-amplifying viral RNA (vRNA) immunotherapy platform and clinical candidates, ONCR-021 and ONCR-788, continue to progress. Oncorus continues to progress its selectively self-amplifying vRNA/lipid nanoparticle (LNP) platform and two clinical candidates, ONCR-021 and ONCR-788, which employ the company’s pioneering IV-administered approach of encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in LNPs. Oncorus is currently initiating GLP safety and tolerability studies for ONCR-021 and anticipates submitting an investigational new drug application (IND) for this program in mid-2023. The company is also conducting preliminary non-GLP safety and tolerability studies for ONCR-788. Oncorus plans to investigate its novel selectively self-amplifying vRNA immunotherapies in multiple therapeutic areas, including cancers of the lung, both as monotherapy and in combination with immune checkpoint inhibitors and possibly other cancer treatments.

Strengthened executive leadership team with promotion of John Goldberg, M.D., to Chief Medical Officer. In February 2022, Oncorus announced the promotion of John Goldberg, M.D. to Chief Medical Officer. Dr. Goldberg responsibilities will continue to include oversight of all clinical studies, drug development and regulatory strategies. Dr. Goldberg previously served as Oncorus’ Senior Vice President of Clinical Development since 2018.
Fourth Quarter 2021 Financial Results

Cash and cash equivalents and investments totaled $123.9 million as of December 31, 2021 compared to $130.3 million as of December 31, 2020.

Research and development expenses for the quarter ended December 31, 2021 were $14.3 million compared to $7.6 million for the corresponding quarter in 2020. The increase was primarily attributable to employee compensation costs, which was driven by increased headcount and increased stock-based compensation, increased rent expense related to the company’s manufacturing facility and increased development costs related to the company’s nominated candidates.

General and administrative expenses for the quarter ended December 31, 2021 were $5.6 million compared to $4.0 million for the corresponding quarter in 2020. The increase was primarily attributable to 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.

Net loss attributable to common stockholders for the quarter ended December 31, 2021 was $19.8 million, or $0.77 per share, as compared to a net loss attributable to common stockholders of $11.8 million, or $0.56 per share for the corresponding quarter in 2020. The increase in the net loss was due to increased expenses associated with the company’s growth and the increase in net loss per share was a result of the increased net loss offset by additional shares issued by the Company in a public stock offering in February 2021.
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.