Diffusion Pharmaceuticals (NASDAQ:DFFN) In Advanced Trial Stages For TSC While The Stock Continues To Hold Strong
Diffusion Pharmaceuticals (NASDAQ:DFFN) is in the advanced stages of Phase 3 trials for trans sodium crocetinate (TSC). The product is the company’s lead drug candidate and it targets patients with inoperable glioblastoma multiforme (GBM). During this phase, the company anticipates to screen 300 patients out of which 230 will be enrolled for the trials.
Phase 2 and 3 trials for TSC are underway, results to be available in two years
According to a statement, the company received official nod from the U.S. Food and Drug Administration (FDA) last year to kick off phase 2 the drug’s trials. In particular, Phase 2 included clinical testing of TSC’s ability to treat acute stroke. As per the statement, the trial results will be available for scrutiny in just under 24 months but contingent on the availability of funding.
The firm is also undertaking Phase 3 of the TSC when taken along with another drug called temozolimid (TMZ). In particular, the trials, dubbed INTACT for (INvestigating Tsc Against Cancerous Tumors) will incorporate both chemo and radiotherapy. The chemotherapy part of the trials will be accomplished using TMZ. For this stage, the company anticipates to release the data by mid-2019 for the run-in cohort. Notably, the primary end point for INTACT trials is to achieve overall survival at two years for the trial subjects.
Strong YTD performance for the stock
The apparent success of the TSC drug candidate is fueling a certain interest in the Diffusion Pharmaceuticals’ stock where the year-to-date performance is strong. Notably, the stock added $1.13 which translates to 56.78% YTD. In particular, the good performance is down to the positive advancement in the lead drug candidate, TSC, impressive financial performance, and a reverse stock split initiated early this year.
In the financial results for the full year 2018, the company reported $8.0 million in cash and cash equivalents as of December 31, 2018. Further, the company used more funds for research during the year compared to 2017. Notably, the higher amount came about as a result of the Phase 3 trials for TSC targeting GBM patients. The company also paid out more money in wages and salary expenses. Nonetheless, the company said that it has enough money that will support this year’s activities through to July.
Initiation of the reverse stock split
On the other hand, the management at Diffusion has been working hard to restore its status at NASDAQ. Earlier, the company had received notice for its non-compliance of trading rules and risked delisting. As part of the remedy, the company initiated a 1-for-15 reverse stock split. In essence, this means that the company would bundle 15 issued and outstanding common stock into one.
Apart from resuming compliance with NASDAQ regulations, the stock split would help to boost the market price of the Diffusion shares. Since the initiation of the stock split, the share price has firmed after plunging to record lows in late December. By mid-March, the stock price was a little over $10.0 although it has pared those gains to $3.12 in the last 24 hours of trading.