Bio-Path Holdings Inc (NASDAQ: BPTH) is having an overwhelmingly strong start to the trading session this morning, and for good reason. Not only did the company release positive interim clinical data, they also released financial data and a corporate update, all of which seem to be exciting investors. Today, we’ll talk about:
- The clinical data that was released by BPTH;
- the financial results offered by the company;
- what we’re seeing from the stock as a result;
- what risks you should be watching for;
- and what we’ll be watching for ahead.
BPTH Announces Positive Interim Clinical Data
As mentioned above, one of the key drivers in the climb we’re seeing out of Bio-Path Holdings today has to do with interim clinical data that was released. In a press release issued early this morning, the company announced interim data from a Phase 2 clinical study. The study was assessing prexigebersen in combination with low-dose cytarbine (LDAC) (BP1001-201) for the treatment of acute myeloid leukemia, also known as AML.
In the release, BPTH said that the data demonstrate that the combined therapy continues to be well-tolerated. On top of that, the treatment is showing early anti-leukemic activity in around half of the evaluable AML patients. Furthermore, the company said that four of these patients have reached complete remission and four of them have reached stable disease to date in the study.
Also, BPTH announced that based on the recommendations of the principal investigators involved in this study, it will be amending the protocol to change the dosing schedule to that used in the Phase 1b study in relapsed and refractory AML patients. Under this protocol, a higher dose of prexigerbesen was administered before LDAC treatment. Also, the company said that the investigators endorse the inclusion of a decitabine cohort based on new and positive data surrounding this compound. In a statement, Peter H. Nielsen, CEO at Bio-Path, had the following to offer:
We are very pleased with these encouraging interim data as they demonstrate the potential for the combination of prexigerbesen and LDAC to effectively treat these de novo AML patients. These early results are encouraging when you consider that the complete response rate in elderly AML patients greater than 65 years of age on LDAC alone have been estimated to be only 10%… We look forward to advancing the planned protocol amendments as we expect they will provide even better results for these patients suffering with AML. If successful, it will provide for approvals in the U.S. and Europe for both combination therapies.
In a second release issued by BPTH this morning, the company issued its financial results for the full year ending December 31,2017 as well as a corporate update. Here’s what we saw from the financial results:
When it comes to net loss, BPTH saw a larger growth year over year. During the year, the company generated a net loss attributable to shareholders in the amount of $8.1 million. That works out to $0.80 per share. In the year prior, the company generated a loss of $6.8 million, or $0.73 per share. In the earnings release, the company said that the increase in net loss was the result of the deemed dividend related to the warrant conversion in 2017. In a statement, Nielsen had the following to offer with regard to the performance of the company in 2017:
During 2017 we made meaningful progress advancing both our clinical and corporate objectives, which has positioned us for continued growth throughout 2018 and beyond… As we move into 2018, we expect to implement the protocol amendments to our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia, to prepare for a Phase 1 clinical trial of BP1002 in lymphoma, to begin enrollment of a Phase 1 clinical trial of prexigebersen in solid tumors potentially by year-end, and to start a series of IND-enabling studies for BP1003 in pancreatic cancer. We continue to have confidence in the performance and potential of our DNAbilize platform technology to produce exciting drug candidates to help patients with high unmet medical need.
How The Stock Is Reacting To The News
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news released by Bio-Path proved to be overwhelmingly positive. Not only are things going well in the ongoing clinical study of prexigebersen, the company is advancing multiple studies in the near term. So, it’s no surprise to see that the stock is making a run for the top in the market today. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:07), BPTH is trading at $2.68 per share after a gain of $0.91 per share or 51.41% thus far today.
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