Proteostasis Therapeutics Inc (NASDAQ: PTI) is having an overwhelmingly rough start to the trading session in the pre-market hours. If you go digging for a reason, you’ll find what appears to be an announcement of positive clinical data. However, investors know how to read between the lines and the announcement was anything but positive. As a result, the stock is tanking. Today, we’ll talk about:
- The data;
- what we’re seeing from PTI as a result; and
- what we’ll be watching for with regard to the stock ahead.
PTI Announces Clinical Data
As mentioned above, Proteostasis Therapeutics is having an incredibly rough start to the trading session this morning after the company announced clinical data. In a press release issued early this monring, the company announced what it called “positive results” from its ongoing 14-day dosing study of PTI-801 in CF patients on background Orkambi® (lumacaftor/ivacaftor) therapy. While the company said that it believes the results support the goal of studying PTI-801 as part of its proprietary double and triple combination therapy regimens, investors aren’t fooled as the data released by the company actually wasn’t all that positive.
From the safety and tolerability side of the coin, the data was positive. However, from an efficacy standpoint, there are definitely concerns. In the release, PTI said that overcoming the typical acute drop in FEV1 associated with lumacaftor exposure, an improvement in ppFEV1 was observed across all cohorts. However, in the same sentance, the company infromed investors that “the change was not statistically significant.” In a statement, Meenu Chhabra, President and CEO at PTI, had the following to offer:
With the addition of PTI-801 to Orkambi, we saw improvements in sweat chloride and weight that, at certain dose levels, reached Kalydeco-like levels and the numerical improvement in FEV1 suggests PTI-801 could potentially double what Orkambi achieves alone. We believe these results demonstrate our ability to deliver a second potential add-on CFTR therapy to enhance current and future CFTR modulator treatments… We believe these results support our development plans for PTI-801 as part of our proprietary doublet and triple combinations. By the end of this quarter, we plan to initiate the Phase 2 study of our once-a-day triplet regimen, which includes PTI-428, our novel CFTR amplifier, PTI-808, our potentiator, and PTI-801. We anticipate reporting initial data from our ongoing doublet study of PTI-801 and PTI-808, followed by our triplet study results, all later this year.
What We’re Seeing From The Stock
One of the first lessons that we learn when wes tart to dig into the market is that the news causes moves. In the case of Proteostasis Therapeutics, the news looked positive. However, after digging into the details, it quickly became clear that it was anything but. So, it’s no surprise to see that upset investors are sending the stock on a tear for the bottom. Of course, our partners at Trade Ideas were the first to alert us to the declines. Currently (8:05), PTI is trading at $3.64 per share after a loss of $1.26 per share or 25.71% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on PTI. In particular, we’re interested in following the story surrounding the company’s ongoing development of PTI-801 as well as PTI-428 and PTI-808. While the data wasn’t as positive as it was framed to be with regard to 801, 428 and 808 may show some promise. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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