On May 15, 2017 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported financial results for the three months ended March 31, 2017 and provided an overview of recent corporate highlights (Press release, Diffusion Pharmaceuticals, MAY 15, 2017, View Source [SID1234519235]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
David Kalergis, Chairman and Chief Executive Officer, stated, "With the completion of our recent private placement, we believe we are now well positioned to advance our clinical development strategy for our lead product candidate, trans sodium crocetinate (TSC). We are in dialogue with the U.S. FDA regarding the design of a Phase 3 trial of TSC in newly diagnosed inoperable GBM patients, and plan to complete a protocol review in the third quarter of 2017. Assuming FDA sign-off on final protocol design, the study is planned to initiate by the end of 2017."
Corporate Highlights
In March 2017, U.S. Patent 9,604,899 entitled "Bipolar Trans Carotenoid Salts and Their Uses" was granted by the United States Patent and Trademark Office. This patent expands the coverage of the therapeutic use of TSC and other related compounds to five hypoxia-related conditions including congestive heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD) and respiratory distress syndrome (RDS).
In March 2017, the Company raised aggregate gross proceeds of $25.0 million in an oversubscribed private placement of its Series A convertible preferred stock. At March 31, 2017, the Company had cash and cash equivalents of $12.2 million and an $8.3 million subscription receivable that was then received on April 3, 2017.
Three Months Ended March 31, 2017 Financial Results
Research and development expenses were $1.0 million for the three months ended March 31, 2017, compared to $2.4 million for the three months ended March 31, 2016. This decrease in research and development was attributable to a decrease in expenses related to the Company’s pancreatic cancer program and animal toxicology studies.
General and administrative expenses were $1.6 million for the three months ended March 31, 2017, compared to $3.9 million for the three months ended March 31, 2016. The decrease in general and administrative expenses was primarily attributable to a decrease in costs attributable to the reverse merger transaction in January 2016.
The Company recognized $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement for the three months ended March 31, 2017, which consisted of the change in fair value of the common stock warrants from issuance, the excess fair value of the common stock warrants over the gross cash proceeds from the Series A preferred stock offering, and placement agent commissions and other offering costs.
Net loss was $28.6 million for the three months ended March 31, 2017, compared to a net loss of $6.2 million for the three months ended March 31, 2016. For the quarter ended March 31, 2017, the net loss included $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement. For the three months ended March 31, 2017, net loss attributable to common shares was $28.7 million, which was inclusive of the dividend payable on the Series A convertible preferred stock.
Net cash used in operating activities for the three months ended March 31, 2017 was $3.4 million compared to $4.6 million during the three months ended March 31, 2016.