Outlook Therapeutics Inc (NASDAQ: OTLK) is having an incredibly strong start to the trading session this morning, and for good reason. The comapny announced its financial results and provided a corporate update, exciting investors and sending the stock for the top. Today, we’ll talk about:
- The corporate update;
- what we’re seeing from the stock; and
- what we’ll be watching for ahead.
OTLK Stock Gains On Update
As mentioned above, Outlook Therapeutics is having an incredibly strong start to the trading session today after providing its financial report and a corporate update. The news came by way of press release early this morning.
All in all, the financial results were as expected. The clinical-stage company is generating a loss, but the balance sheet was bolstered by a recent $28.4 million public offering of common stock and warrants. So, financially, OTLK seems to be on solid ground.
Nonetheless, the big story here is the progress that the company is making with regard to ONS-5010. This is the comapny’s monoclonal antibody therapeutic product candidate. At the moment, the candidate is enrolling patients in a Phase 3 clinical trial in Australia.
This trail was designed to serve as the first of two adequate and well controlled studies evaluating the treatment in comparison to ranibizumab for wet age related macular generation. In the release, OTLK said that enrollment is nearly complete with 51 of 60 patients enrolled to date.
The company also reminded investors that it initiated the second Phase 3 trial in the United States, Australia and New Zealand. In this trial, dosing is expected to begin in June.
If these two trials prove to be successful, the company said that it will submit for regulatory approval in multiple markets in 2020. With off-label use of Avastin accounting for about half of all wet AMD prescriptions in the United States, the market potential here is incredible.
In a statement, Lawrence A. Kenyon, President, CEO and CFO at OTLK, had the following to offer:
We are pleased with the progress being made in both of our Phase 3 clinical trials for ONS-5010 thus far in 2019, which includes the FDA’s acceptance of our IND for ONS-5010 and the initiation of our second Phase 3 trial. The two studies remain on track with our plan to submit ONS-5010 for regulatory approval in multiple markets in 2020.
The financing we secured in the equity offering announced in April has provided us with the capital needed to complete enrollment in our two Phase 3 clinical trials. This was an important step in our strategy and to maintain the positive momentum behind our clinical development program for ONS-5010.
We continue to attract exceptionally talented people from the wet AMD and retinal disease industry to Outlook Therapeutics. The industry knowledge and experience of those like Dr. Kissner will allow us to efficiently execute on our strategy to advance our streamlined ONS-5010 program through clinical development and, pending the outcome of our trials and regulatory approval, properly implement an effective commercialization strategy.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. When it comes to Outlook Therapeutics, the news proved to be overwhelmingly positive.
After all, if all goes well in clinical trials, the company could have regulatory applications across several markets as soon as next year. Also, with the recent fund raise, the company is standing on strong financial ground at the moment. So, it’s not surprising to see that investors are reacting in a positive way.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:51), OTLK is trading at $1.16 per share after a gain of $0.25 per share or 27.42% 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 OTLK. In particular, we’re interested in following the story surrounding the company’s continued work to bring ONS-5010 to market. Nonetheless, we’ll keep an eye on the story and bring the news to you as it breaks!
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