On August 11, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that may enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the quarter ended June 30, 2022, and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 11, 2022, View Source [SID1234618241]).
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Development Updates
Aligned with FDA on Innovative Trial Design in Glioblastoma Multiforme ("GBM") Patients: In July 2022, Diffusion announced that it had aligned with the U.S. Food and Drug Administration ("FDA") on the design of an open-label, dose-escalation, Phase 2 safety and efficacy study of its lead product candidate, trans sodium crocetinate ("TSC"), administered with standard of care to patients newly diagnosed with glioblastoma multiforme. The trial, which has been designated Study 200-208, has been designed to incorporate an innovative use of positron emission tomography ("PET") to map hypoxia within the tumor. The use of PET is designed to allow the Company to directly quantify the effects of TSC on tumor hypoxia, and thereby test TSC’s ability to enhance oxygen within the tumor microenvironment. These initial imaging readouts are expected to be available within one year of study initiation, thereby providing objective surrogate data readouts significantly faster than historical clinical trials in patients with GBM. The Company expects to initiate the trial by the end of 2022 with the first patient dosed in the first quarter of 2023.
Reported Positive Results from Altitude Trial: In June 2022, positive results were reported from the Company’s Altitude Trial. The data suggested that a higher dose of TSC (2.5 mg/kg dose) decreased blood acidity (lower lactate accumulation) and enhanced metabolic recovery at 10 minutes after completion of exercise under the stressful conditions of simulated high altitude and exercise. Additionally, positive changes were observed in blood markers of oxygen utilization, indicating that TSC may enhance oxygen availability at the cellular level, reinforcing Diffusion’s belief in the therapeutic potential of TSC.
"During the second quarter of 2022, we maintained significant momentum across our clinical and corporate programs achieving clinical and operational milestones we believe will help build Diffusion’s long-term success. Specifically, we were pleased to report positive results from our Altitude Trial, which we believe support our plans for further development of TSC to treat hypoxic solid tumors like GBM," commented Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "Additionally, we are very pleased to have reached alignment with the FDA on an innovative GBM Trial design, and our team is already working to initiate the trial. We believe TSC has the potential to enhance the effectiveness of available treatment of this devastating disease."
Business Updates
Appointed Raven Jaeger, M.S., as Chief Regulatory Officer: In May 2022, Diffusion appointed Ms. Raven Jaeger as the Company’s Chief Regulatory Officer. Ms. Jaeger will, among other things, oversee the development and implementation of regulatory and related strategies to support the development and commercialization of Diffusion’s product development candidates.
Ended Quarter with $28.5 Million in Cash, Cash Equivalents and Marketable Securities with Expected Cash Runway into First Quarter of 2024
Research and development expenses in the second quarter of 2022 were $2.1 million, compared to $2.0 million in the prior year period. There was a decrease in costs associated with clinical trials and drug manufacturing, offset by an increase in salaries and wages and stock-based compensation related to increased headcount.
General and administrative expenses were $2.1 million during the second quarter of 2022 versus $1.8 million in the comparable quarter last year. The increase reflects a rise in professional fees related to the reverse stock split that occurred in April 2022, as well as increased salary expenses related to additional headcount.
As of June 30, 2022, Diffusion had $28.5 million in cash, cash equivalents, and marketable securities, which the Company currently expects will enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2024, without giving effect to any business development activities the Company may undertake.