On August 13, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on improving patient outcomes in unmet medical needs using its novel small molecule trans sodium crocetinate (TSC), reported its financial results for the three months ended June 30, 2018 and provides a business update (Press release, Diffusion Pharmaceuticals, AUG 13, 2018, View Source [SID1234529170]).
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Commenting on the second quarter, David Kalergis, Chairman and Chief Executive Officer, said, "We have continued to screen and enroll patients with inoperable glioblastoma multiforme (GBM) into our INTACT Phase 3 pivotal trial. Following the dose escalation run-in portion, this planned 236-patient study will enroll half the patients in the treatment arm consisting of standard-of-care radiation and chemotherapy plus TSC, and half in the control arm, which is standard-of-care alone. We designed INTACT based on our Phase 2 study that demonstrated a nearly four-fold increase in overall survival at two years in inoperable GBM patients."
Mr. Kalergis continued, "During the quarter, U.S. Patent 9,950,067 issued relating to methods of treating cancer using bipolar trans carotenoids including TSC. European patent 2575487 was validated for oral formulations of bipolar trans carotenoids and includes novel compositions in tablet, pill or capsule form. Further, US Patent 10,016,384, also relating to oral formulations of bipolar trans carotenoids, issued on July 10, 2018. We believe TSC holds great promise in treating a number of diseases in addition to cancer and are pleased to be able to protect a patient-friendly oral formulation suitable for more chronic uses. Our intellectual property protection further supports the value of TSC as we discuss partnership opportunities in various indications and geographies."
Diffusion is continuing preparations for a Phase 2 randomized, double-blind, placebo-controlled trial with TSC in acute stroke in cooperation with UCLA and the University of Virginia, and is in discussions with potential partners. Financing permitting, we expect to begin enrolling patients in early 2019 with data in about 18 months thereafter. The study calls for the administration of TSC by specially-trained Emergency Medical Technicians to ambulance-transported patients within two hours of the onset of a suspected acute stroke. In-ambulance administration could overcome the current severe timing delay in administering therapy to stroke victims, serving a market of up to 800,000 patients a year who suffer acute stroke.
Financial Results for the Three Months Ended June 30, 2018
We had cash and cash equivalents of $12.9 million as of June 30, 2018. We believe that our cash and cash equivalents will enable us to fund our obligated operating expenses and capital expenditure requirements into September 2019.
We recognized $1.4 million in research and development expenses during the three months ended June 30, 2018, compared with $1.2 million during the three months ended June 30, 2017. The increase was mainly attributable to a $0.8 million increase in expenses related to our Phase 3 GBM trial, offset by a $0.6 million decrease in expense associated with manufacturing costs.
General and administrative expenses for the three months ended June 30, 2018 were $1.7 million, compared with $1.8 million for the three months ended June 30, 2017. The decrease in general and administrative expense was primarily due to a $0.3 million decrease in professional fees, partially offset by an increase in salary and wages expense of $0.2 million.
Net cash used in operating activities for the first half of 2018 was $5.8 million, compared with $6.2 million during the same period in the prior year.