Oncorus Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

On March 24, 2023 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing intravenously administered, self-amplifying RNA to transform outcomes for cancer patients, reported fourth quarter and full year 2022 financial results and provided an update on its business (Press release, Oncorus, MAR 24, 2023, View Source [SID1234629302]).

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"We are poised for a year of strong execution as we head further into 2023. Oncorus is pioneering a first-of-its-kind, self-amplifying RNA platform with an exciting lead program, ONCR-021, which is an intravenously (IV) administered viral RNA encoding an optimized genome of Coxsackievirus 21A. We plan to submit an IND with the FDA for ONCR-021 in mid-2023," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "Our mission is to realize the full promise of IV-administered RNA medicines to transform outcomes for cancer patients. As leaders in the self-amplifying RNA and LNP delivery space, we continue to focus our development efforts on overcoming the challenges associated with today’s approved IV-administered, RNA-based therapeutics. I believe that our innovative science and our exceptional team position us to achieve our mission."

Business Highlights

Reprioritized portfolio to focus on IV-administered, self-amplifying RNA medicines. In November 2022, Oncorus announced a pipeline reprioritization to focus on ONCR-021, in addition to discontinuing its Phase 1 clinical trial of ONCR-177 and reducing its workforce and operating expenses. The company announced that further development of additional pipeline programs, including ONCR-788 and ONCR-719, will be dependent on the receipt of additional financing or support from strategic partnerships.
Self-amplifying RNA platform continues to progress. Oncorus remains on track to submit an IND for ONCR-021, the lead product candidate from its self-amplifying RNA platform, in mid-2023. The company plans to evaluate ONCR-021 in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular carcinoma and anaplastic thyroid cancer.
Preclinical results featured in Nature Communications support IV-administered self-amplifying RNA/lipid nanoparticle (LNP) platform. In October 2022, Oncorus published preclinical data in Nature Communications highlighting the potential of its self-amplifying RNA platform as a novel approach to treating cancer by enabling tumor specific replication with systemic dosing. The data demonstrate that the delivery of RNA encoding for the genome of a replication competent virus encapsulated in an LNP enables selective replication, virus assembly and spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of anti-viral neutralizing antibodies in the bloodstream. These results support the potential of this modality to safely and effectively kill tumor cells, while stimulating multiple arms of the immune system to better fight cancer.
Fourth Quarter 2022 Financial Results

Cash, cash equivalents and investments totaled $62.2 million as of December 31, 2022 compared to $123.9 million as of December 31, 2021.

Research and development expenses for the quarter ended December 31, 2022 were $15.7 million compared to $14.3 million for the corresponding quarter in 2021. The increase was primarily attributable to extensive pre-clinical work associated with our ONCR-021 program, as well as increased facility-related expenses to support our GMP manufacturing facility.

General and administrative expenses for the quarter ended December 31, 2022 were $5.1 million compared to $5.6 million for the corresponding quarter in 2021. The decrease was primarily attributable to savings from decreased annual insurance premiums, as well as decreased stock-based compensation due to our lower stock price in 2022.

Net loss for the quarter ended December 31, 2022 was $20.9 million, or $0.81 per share, as compared to a net loss of $19.8 million, or $0.77 per share for the corresponding quarter in 2021. The increase in net loss was due to higher research and development expenses as described above, as well as interest expense associated with our venture debt which was executed in April 2022.
Financial Guidance

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