On May 4, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported first quarter 2022 financial results and highlighted recent achievements and developments (Press release, Oncorus, MAY 4, 2022, View Source [SID1234613473]).
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"Early 2022 has been focused on clinical and operational execution as we work toward operational completion of our manufacturing facility, as well as extending our cash runway to support our dual platform approach to next-generation viral immunotherapies. We plan to share additional ONCR-177 Phase 1 data from the surface lesion monotherapy expansion and the initial combination expansion data with KEYTRUDA in the second half of 2022, while we continue to advance our vRNA drug candidates and LNP capabilities in parallel," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We recently presented exciting preclinical data from our selectively self-amplifying vRNA/LNP immunotherapy platform at AACR (Free AACR Whitepaper) demonstrating the full potential of our IV-administered viral immunotherapy candidates, ONCR-021 and ONCR-788, in overcoming well-established limitations of RNA-based therapeutics. We look forward to further positioning Oncorus for growth driven by our dual-platform pipeline of product candidates targeting cancers with significant unmet need, which is enabled by our wholly owned GMP-compliant manufacturing infrastructure."
First Quarter 2022 and Recent Business Highlights
On track to report additional ONCR-177 monotherapy and combination data in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of its Phase 1 open-label, multi-center 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 future data readouts expected in the second half of 2022. Data readouts are expected to include both additional surface lesion monotherapy expansion data for ONCR-177 and initial surface lesion combination expansion data for ONCR-177 administered with KEYTRUDA.
Presented preclinical data for ONCR-021 and ONCR-788 supporting the company’s selectively 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 (FDA) in mid-2023 and a subsequent IND submission for ONCR-788.
Announced debt capital facility with K2 HealthVentures (K2HV); $20 million funded at closing: In April 2022, Oncorus entered into a loan and security agreement with K2HV, a healthcare-focused specialty finance company. The term loan facility provides Oncorus with up to $45 million available in multiple tranches upon the achievement of certain time-based, clinical and regulatory milestones, with the initial tranche of $20 million funded at closing. Oncorus intends to use the proceeds of the initial tranche of the loan facility to complete the buildout of its Andover facility and to continue the advancement of its pipeline of next generation viral immunotherapies for cancer and LNP technologies.
Announced relocation of all operations to Andover, Massachusetts facility in fourth quarter of 2022 to increase operational efficiency: In April 2022, Oncorus announced plans to relocate all operations to its facility in Andover, Massachusetts in the fourth quarter of 2022, allowing research, process development and Good Manufacturing Practice (GMP)-compliant manufacturing to occur all in one facility.
First Quarter 2022 Financial Results
Cash and cash equivalents and investments totaled $98.7 million as of March 31, 2022 compared to $123.9 million as of December 31, 2021.
Research and development expenses for the quarter ended March 31, 2022 were $12.5 million compared to $8.4 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, which was driven by increased headcount and increased 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 March 31, 2022 were $5.3 million compared to $4.2 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, including higher stock-based compensation, increased headcount and increased salary and related expenses.
Net loss for the quarter ended March 31, 2022 was $17.8 million, or $0.69 per share, as compared to a net loss of $12.7 million, or $0.53 per share for the corresponding quarter in 2021. The increase in net loss was due to increased expenses associated with the Company’s preclinical development costs of its nominated candidates.
Financial Guidance
As a result of the debt capital facility and operations relocation, as well as other initiatives to increase operational efficiency, Oncorus now expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.