On May 22, 2023 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing intravenously administered, self-amplifying RNA to transform outcomes for cancer patients, reported its first quarter financial results and provided an update on its business (Press release, Oncorus, MAY 22, 2023, View Source [SID1234631918]).

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"Oncorus is pioneering a first-of-its-kind, self-amplifying RNA platform with an exciting lead program, ONCR-021, with plans to submit an IND with the FDA in mid-2023," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "Our exceptional team continues to drive our mission of realizing the full promise of IV-administered RNA medicines for cancer patients."

Business Highlights

Progressed Self-amplifying RNA platform. Oncorus still plans to submit an investigational new drug application (IND) for ONCR-021, the lead product candidate from its self-amplifying RNA platform, in mid-2023, subject to receipt of additional funding for continued clinical development of the program. 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.
Appointment of Interim Chief Financial Officer. On May 9, 2023, Oncorus appointed Alexander Nolte as its interim Chief Financial Officer. Prior to joining Oncorus, Mr. Nolte served as Vice President, Chief Accounting Officer, at Syndax Pharmaceuticals. Prior to Syndax, he served as Corporate Controller at CoLucid Pharmaceuticals, Inc. until its acquisition by Eli Lilly. Earlier in his career, Mr. Nolte held various positions within the finance functions of Aegerion Pharmaceuticals and Genzyme Corporation. Mr. Nolte began his professional career at KPMG Accountant NV in the Netherlands and PricewaterhouseCoopers LLP.
Payoff of Debt Capital Facility with K2 HealthVentures. On May 12, 2023, Oncorus prepaid approximately $21.6 million to K2 HealthVentures LLC (K2HV), its senior lender, in full satisfaction of all obligations, including all outstanding principal, accrued interest, fees, costs, expenses and other amounts chargeable under the Loan and Security Agreement, dated April 1, 2022, by and between Oncorus and K2HV. The payoff terms provided for the termination of all commitments and obligations under the Loan and Security Agreement and related documents and the release of all liens held by K2HV on Oncorus’ assets.
First Quarter 2023 Financial Results

Cash, cash equivalents and investments totaled $45.0 million as of March 31, 2023 compared to $62.2 million as of December 31, 2022.

Research and development expenses for the quarter ended March 31, 2023 were $10.6 million compared to $12.5 million for the corresponding quarter in 2022. The decrease was primarily attributable to the reduction in direct external expenses for ONCR-177 in connection with the winding down of the program and the reduction in employee compensation costs, primarily due to employee turnover and decreased fulltime headcount.

General and administrative expenses for the quarter ended March 31, 2023 were $4.5 million compared to $5.3 million for the corresponding quarter in 2022. The decrease was primarily attributable to the reduction in employee compensation and related expenses, primarily due to employee turnover and decreased fulltime headcount and a decrease in professional service and consultant fees primarily related to decreased consultant costs and decreased recruiting costs.

Net loss for the quarter ended March 31, 2023 was $30.9 million, or $1.18 per share, as compared to a net loss of $17.8 million, or $0.69 per share for the corresponding quarter in 2022. The decrease in net loss was primarily due a long-lived asset impairment charge of $14.6 million taken on March 31, 2023 and lower research and development and general and administrative expenses, as described above.

Financial Guidance

Oncorus expects its cash, cash equivalents and investments, following the full prepayment of its debt capital facility with K2HV in May 2023, to fund its operations into the third quarter of 2023. The foregoing estimate does not give effect to potential business development opportunities or additional financing activities.