On November 10, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended September 30, 2021 and provided a business update (Press release, Phio Pharmaceuticals, NOV 10, 2021, View Source [SID1234595110]).
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"Our development programs continue to generate positive in vivo data showing how INTASYL technology can be utilized in various applications to treat cancer. These data have generated broad interest in our programs as we prepare to enter the clinic with the initiation of two trials expected in the next couple of quarters," said Dr. Gerrit Dispersyn, President and CEO of Phio. "We expect to initiate our first-in-human clinical study of our lead program, PH-762, in the first quarter of 2022, which will be followed by the first study with PH-762-empowered tumor infiltrating lymphocyte therapy to start in Q2. In addition, we’ve generated a lot of exciting in vivo data in support of the development of our PH-894 compound, showing it provides enhanced immunotherapeutic activity by reprograming T cells and other cells in the TME, and supporting our plans to file for a clinical trial application with the FDA in the second half of 2022."
Quarter in Review and Recent Corporate Updates
Presented positive data from several in vivo preclinical studies demonstrating the flexibility and application of INTASYL in the field of immuno-oncology at leading scientific conferences held during the third quarter of 2021:
Announced new data showing that local treatment in vivo with INTASYL has the potential to cure locally treated and distal untreated tumors and generate systemic tumor immunity that is both durable and tumor specific, further highlighting the technology’s potential in direct therapeutic applications. Data from this study, presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, showed a complete response in up to 83% of the animals treated with a low dose formulation of dual-targeting INTASYL PH-3861 (targeting PD-1 and BRD4).
Introduced new in vitro and in vivo data that showed silencing BRD4 with INTASYL compound PH-894 had a significant impact on T cell function and phenotype promoting T cell activation and immunosuppression in the tumor microenvironment as presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). These new data build upon a growing body of evidence that BRD4 plays a role in tumor cells and can also regulate T cell function, and that PH-894 can reprogram T cells to provide enhanced immunotherapeutic activity.
Completed additional in vivo and in vitro preclinical studies with PH-894, an INTASYL product candidate for direct drug therapy, which showed the potential of INTASYL compounds to modulate the expression of intracellular and/or commonly considered "undruggable" targets, such as epigenetic targets. These data will support our regulatory filings and the Company expects to file a clinical trial application for PH-894 in the second half of 2022.
Upcoming Pipeline Milestones
Expect to initiate a first-in-human clinical study on the direct therapeutic use of PH-762 in patients with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Expect to file a clinical trial application for PH-894 in the second half of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results
Cash Position
At September 30, 2021, the Company had cash of $26.5 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.
Research and Development Expenses
Research and development expenses were approximately $2.8 million for the quarter ended September 30, 2021, compared to approximately $1.3 million for the quarter ended September 30, 2020. The increase in research and development expenses was primarily due to manufacturing costs for the Company’s PH-762 and PH-894 INTASYL compounds and fees for the required preclinical studies in support of the Company’s clinical trials for PH-762 as compared to the same period in the prior year.
General and Administrative Expenses
General and administrative expenses were approximately $0.9 million for the quarter ended September 30, 2021, compared to approximately $1.1 million for the quarter ended September 30, 2020. The decrease is primarily due to a decrease in legal fees partially offset by increased stock-based compensation expense as the Company did not grant equity awards in the same period in the prior year.
Net Loss
Net loss was $3.7 million, or $0.28 per share, for the quarter ended September 30, 2021, compared with $2.3 million, or $0.40 per share, for the quarter ended September 30, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s preclinical activities in preparation for the start of its clinical trials with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.