TG Therapeutics Lines Up Potential Accelerated Approval For Cancer Drug

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About: TG Therapeutics, Inc. (TGTX)
by: Terry Chrisomalis
Summary

TG Therapeutics achieved positive results from the phase 2b UNITY-NHL study using umbralisib in patients with MZL.

With the positive results observed in the MZL patient population, TG Therapeutics is set to meet with the FDA soon to potentially seek accelerated approval based on the reported data.

Before any potential NDA filing for umbralisib, TG Therapeutics is going to await for additional data from MZL patients in the UNITY-NHL study such as: Safety, DOR and PFS.

TG Therapeutics recently announced $85 million in equity and debt financing that will be enough to carry the company forward, which means no risk of near-term dilution.

TG Therapeutics (TGTX) is a good biotech to look into because it has proven itself in a few mid-stage clinical studies. The reported results from UNITY-NHL study were highly positive for the biotech and for those patients with marginal zone lymphoma (MZL). This builds upon the opportunity for the UNITY-NHL study which is exploring Umbralisib in many other non-Hodgkin's lymphoma indications.

Phase 2 Data Marginal Zone Lymphoma

It was noted that TG Therapeutics saw positive results in its phase 2b UNITY-NHL study from the Marginal Zone Lymphoma cohort. Before diving any further, it is important to note that this study is testing multiple kinds of non-hodgkin's lymphoma (NHL). Therefore, this latest update on data involves only those patients with Marginal Zone Lymphoma (MZL). Specifically, this phase 2b cohort involved patients with relapsed/refractory MZL and were treated with umbralisib. In essence, umbralisib is a phosphoinositide 3-kinase (PI3K) delta inhibitor. The basic premise is that PI3K is found on both healthy cells and cancer cells. However, cancer cells have an abundant amount of PI3K that regulate them. Umbralisib has the ability to inhibit the signaling function of PI3K.

The recently reported data was very strong, and this gives a lot of credibility to umbralisib. The MZL cohort of this phase 2b study recruited a total of 69 patients who received at least one dose of umbralisib. An important item to note is that these patients had to first receive treatment with at least one prior anti-CD20 regimen before they could enter the study. The primary endpoint of the study was overall response rate (ORR), which was to be analyzed by an Independent Review Committee (IRC). Here is why I believe the results were really strong, which I will go over in detail soon. That's because the primary endpoint wasn't supposed to be determined until all treated patients had completed at least 9 cycles of follow-up (one cycle = 28 days). What that means is that the primary endpoint wasn't expected to to be met until the study finished in its entirety. However, the interim analysis done by the IRC noted that the ORR percentage reached the target necessary for potential approval. It was noted that MZL patients treated with umbralisib reached the 40% to 50% ORR expectation of TG Therapeutics. This was the best final outcome, not only because it met the primary endpoint but also because the trial proved umbralisib was effective for these patients. That's because the biotech didn't expect to achieve the ORR necessary to speak with the FDA for potential accelerated approval so soon. It hopes to have a meeting with the FDA as soon as possible. If all goes well, then an NDA for using umbralisib in MZL patients can potentially be filed by the end of 2019. The reason why it's going to take until the end of 2019 for the filing is, because there will be additional data that will come in from this study. Such additional data will be: Duration of response (DOR), progression-free survival (PFS), and long-term safety. All these additional endpoints will help support the potential NDA filing by year's end.

Financials

According to the 10-Q SEC filing, TG Therapeutics had cash of $97.8 million as of September 30, 2018. Of course, with the pipeline and clinical stage development ongoing, this cash wasn't expected to last. However, there is good news on this front. That's because the risk of a cash raise is now out of the way. The biotech completed two items this past week to raise a large amount of cash. On February 28, 2019, it entered into a $60 million venture debt facility with Hercules Capital. The bottom-line is that TG Therapeutics received $30 million upfront. The rest is tied to other customary closing conditions. For example, two tranches of $10 million can be drawn when the biotech needs to, but only if certain clinical trial milestones are met. Then the final $10 million is available up through December 15, 2020. It's important to point out that the last $10 million has to be approved by Hercules though. That's just one portion of the raise. The following day, it enacted a public offering in which it sold shares of its common stock to generate $25.2 million, before the deduction of underwriter discounts, commissions, and offering expenses. Then there was an additional $3.8 million worth of shares sold as well. In totality, the biotech raised $85 million on top of its current cash on hand. While that was painful, it gives the company a nice extended cash runway for a while. This means that the risk of further dilution has now been minimized. That doesn't mean that it won't ever be back on the table, but I expect this cash to help fund the company for quite some time.

Conclusion

TG Therapeutics is on the right track with its UNITY-NHL study. The positive results observed in the patients with MZL means that there is potential for accelerated approval for this patient population because it is an unmet medical need. Before then, the biotech has to first meet with the FDA to incorporate a plan on a potential pathway for approval of umbralisib in this patient population. The risk is that there is no guarantee that the FDA will allow for accelerated approval of this drug in MZL patients. If that happens, then an additional late-stage study may be needed for approval. Other risks involve the other indications being explored in the UNITY-NHL study. In essence, not all the indications in this study will move on towards regulatory approval. However, thus far TG therapeutics has seen solid data from not only MZL but also in patients with chronic lymphocytic leukemia (CLL).

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.