On August 4, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported financial results for the second quarter of 2022 and highlighted recent achievements and developments (Press release, Oncorus, AUG 4, 2022, View Source [SID1234617469]).

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"In recent months, Oncorus has maintained momentum across our portfolio of next-generation viral immunotherapies with ongoing enrollment of patients in the ONCR-177 Phase 1 clinical trial and continued IND-enabling studies for ONCR-021, our lead self-amplifying vRNA/LNP program," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We are preparing for the next phase of our growth as our pipeline matures and as we operationalize our GMP-compliant manufacturing facility by the end of this year. In our ongoing Phase 1 clinical trial of ONCR-177, we remain on track to report initial data from 15 to 20 patients from our expansion cohort in combination with Merck’s KEYTRUDA, along with additional surface lesion monotherapy data by the end of 2022."

Second Quarter 2022 and Recent Business Highlights

On track to report combination data and additional monotherapy data for ONCR-177 in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of 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 continues to enroll patients in the combination cohort with initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data expected in the second half of 2022.

Presented preclinical data for ONCR-021 and ONCR-788 supporting the company’s self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. In April 2022, Oncorus presented preclinical data for both ONCR-021 and ONCR-788 in two e-posters at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating robust preclinical anti-tumor efficacy in multiple tumor models while avoiding the challenges seen in previous studies that incorporate IV administration of RNA-based oncology therapeutics. Oncorus plans to submit an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration in mid-2023 and a subsequent IND submission for ONCR-788.

Announced debt capital facility with K2 HealthVentures (K2HV) with $20 million funded at closing and planned relocation to Andover, Massachusetts facility: In April 2022, Oncorus entered into a loan and security agreement with K2HV, a healthcare-focused specialty finance company, which provides Oncorus with up to $45 million available in multiple tranches upon the achievement of certain time-based, clinical and regulatory milestones. Oncorus also announced plans to relocate all operations to its facility in Andover, Massachusetts in the fourth quarter of 2022 to increase operational efficiency, allowing research, process development and Good Manufacturing Practice (GMP)-compliant manufacturing to occur all in one facility.
Second Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $100.2 million as of June 30, 2022 compared to $98.7 million as of March 31, 2022.

Research and development expenses for the quarter ended June 30, 2022 were $12.5 million compared to $10.7 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 June 30, 2022 were $6.2 million compared to $4.9 million for the corresponding quarter in 2021. The increase was primarily attributable to increased headcount, which drove higher employee compensation and stock-based compensation, as well as increased rent expense related to the company’s manufacturing facility.

Net loss for the quarter ended June 30, 2022 was $19.1 million, or $0.74 per share, as compared to a net loss of $15.5 million, or $0.60 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.