Operational Highlights for the First Quarter Ended March 31, 2023:
- Announced positive new data from Phase III clinical trial interim analysis. Data suggests a 60% survival benefit and greater than 65% reduction in side effects compared to systemic chemotherapy.
- Announced initial results in pharmacokinetic (PK) substudy: data on RenovoGem supports potential for the RenovoTAMP® therapy platform to increase local gemcitabine (chemotherapy) delivery and decrease side effects of pancreatic cancer treatment.
- Issued 8th U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform.
- Acceptance of four clinical data abstracts at the 2023 ASCO Gastrointestinal Cancer Symposium.
Highlights Subsequent to the First Quarter Ended March 31, 2023:
- Appointed Robert J. Spiegel, MD, FACP, former Chief Medical Officer of Schering-Plough, to the Board of Directors.
- Appointed Leesa Gentry as Senior Vice President of Clinical Operations.
- Presented Phase III interim analysis data of the TIGeR-PaC study at the 2023 American Association for Cancer Research (AACR) in Orlando, Florida.
- Closed $5 million registered direct offering.
Financial Highlights for the First Quarter Ended March 31, 2023
- Cash and cash equivalents as of March 31, 2023, were $3.7 million.
- Research and development expenses were $1.3 million for the quarter ended March 31, 2023, compared to $1.3 million, relatively flat compared to the quarter ended March 31, 2022. Clinical consulting support for the ongoing Phase III clinical trial increased $0.1 million, which was offset by a decrease in our Phase III clinical trial costs of $0.1 million primarily due to suspending the European Phase III clinical trial.
- General and administrative expenses were $1.9 million for the quarter ended March 31, 2023, compared to $1.7 million for the quarter ended March 31, 2022. The increase was primarily due to higher employee and related benefit costs of $0.3 million, an increase in professional consulting fees of $0.2 million. This increase was partially offset by an increase of $0.2 million in allocated general and administrative expenses to research and development including other miscellaneous general and administrative costs of $0.1 million.
- Net loss was $3.3 million for the quarter ended March 31, 2023, compared to net loss of $3.0 million for year ended March 31, 2022.
- As of March 31, 2023, the Company had 9,097,701 common shares outstanding.
