On May 12, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the quarter ended March 31, 2022, and provided a business update (Press release, Diffusion Pharmaceuticals, MAY 12, 2022, View Source [SID1234615255]).

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Business Updates

Completed Dosing in Altitude Trial: The Company announced the last participant in this study of its lead product candidate, trans sodium crocetinate ("TSC"), completed dosing in April 2022 and topline data are expected in June 2022. Two abstracts, based on blinded, aggregated (placebo and treatment), interim physiological data from a subset of study participants, will be presented by the clinical investigators at the Undersea and Hyperbaric Medical Society’s Annual Scientific Meeting in Reno, Nevada being held from May 22-26, 2022.
Continued Enrollment in TSC ILD-DLCO Trial: Diffusion announced dosing of the first patients in December 2021 and enrollment continued during the first quarter of 2022. The Company currently anticipates completing dosing in the second half of 2022 and reporting topline results within two months of study completion.
Expanded Scientific Advisory Board: In February 2022, the Company announced the addition of five prominent radiation and medical oncologists to its Scientific Advisory Board ("SAB") to further support development of TSC, as an adjunctive treatment for hypoxic solid tumors.
Maintained Solid Cash Position: As of March 31, 2022, Diffusion reported $32.6 million in cash, cash equivalents, and marketable securities, which is expected to fund the Company’s operating expenses and capital expenditure requirements through 2023.
Regained Nasdaq Compliance: In May 2022, the Company announced that it had regained compliance with the Nasdaq Capital Market’s continued listing requirements, following the bid price of the Company’s common stock closing above $1.00 for 10 consecutive trading days.
"We believe 2022 has the potential to be a transformational year, as we anticipate the topline data readout from the Altitude Trial in June and the completion of patient dosing in our ILD-DLCO trial later this year," commented Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "With our strong cash position, experienced development team, and the appointment of our new and distinguished SAB members, we believe Diffusion is now effectively positioned to launch our Hypoxic Solid Tumor Program aimed at evaluating TSC as an adjunctive treatment for hypoxic solid tumors. Our team worked hard during the first quarter, evaluating various options in designing an appropriate clinical study protocol and amending our oncology investigational new drug application for TSC to support a start date for the first trial in the program in the second half of 2022. We look forward to providing updates on these development activities that we hope will drive both patient and shareholder value."

Financial Results

Research and development expenses in the first quarter of 2022 were $2.4 million, compared to $2.9 million in the prior year period. A significant portion of this decrease was attributable to the timing of clinical trials and drug manufacturing, offset by an increase in salaries, wages and stock-based compensation related to increased headcount.
General and administrative expenses were $2.1 million during the first quarter of 2022 versus $1.7 million in the comparable quarter last year. The increase compared to the prior year period was mainly due to an increase in salaries, wages, and stock-based compensation related to increased headcount, as well as an increase in outside professional fees to support business activities during the quarter.
As of March 31, 2022, Diffusion had cash, cash equivalents, and marketable securities of $32.6 million, compared to $46.6 million as of March 31, 2021.