UroGen: Update After Data Release – UroGen Pharma Ltd. (NASDAQ:URGN)

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After the release of the data, I thought that there was no need to continue this topic, as my expectations were confirmed. But the fact is that, in view of some speculations on this topic, attempts to interpret article conclusions differently, I would like to give my final assessment, taking into account the already updated data.

First of all, I would like to clarify that my previous article about UroGen (NASDAQ:URGN) was written and submitted for publication before the publication of the recent data, and I did not have the latest results of clinical trials.

UroGen released clinical updates on September 24, 2019. For the details, please click here.

In a previous article, I shared my thoughts in detail about the UGN-102 and its vague prospects to replace the SOC. Unfortunately, additional data only confirmed my assumptions:

Image source: company PR

I will not waste your time discussing UGN-102 and SOC again, but for those who are interested, I suggest reading my previous article.

I think people will agree that these results do not allow us to discuss the prospects of UGN-102 for replacing SOC (including transurethral resection of the bladder tumor) in Non-Muscle Invasive Bladder Cancer (NMIBC).

The remaining late stage drug candidate is UGN-101 mitomycin gel (MitoGel) for instillation in patients who are diagnosed with low-grade upper tract urothelial carcinoma.

Firstly, constantly in the case of the corporate presentation, as well as analysts’ estimates, the wrong numbers of potential patients per year are foreseen. Apparently, many simply took these figures from the company’s presentation (6,000-8,000 annual patients):

image from Urogen company presentationImage source: UroGen company presentation

Annual incidence of upper track urothelial carcinoma (UTUC) is 1-2 cases per 100,000 inhabitants.

The U.S. population estimate for 2019 is 329 million. Thus, the total annual incidence of UTUC in 2019 is estimated between 3,290 and 6,580 patients. In UTUC tumors, there are several characteristics which allow doctors to obtain the stage (level of invasion) and grade (aggressiveness).

And now, the most important thing, which part of the patients is low grade (LG) UTUC (indication for UGN-101)?

https://www.bcan.org/wp-content/uploads/2017/12/UTUC-Part-1-1.pdfImage source: Bladder Cancer Advocacy Network

About 35% of UTUC are low grade, while remaining 65% is high grade.

So, at this stage, our calculations show 35% of (3,290-6,580) = range between 1,152 and 2,303. The question remains where did the figures of 6,000-8,000 come from?

As I said before, except for grade, tumors are also classified into stages (level of invasion), as indicated in the image below:

https://www.bcan.org/wp-content/uploads/2017/12/UTUC-Part-1-1.pdfBelow, you can find even more detailed classification:

Urotoday.comNow, here is the patient inclusion criteria from UroGen’s Phase-3 Olympus trial:

https://clinicaltrials.gov/ct2/show/NCT02793128?term=Phase+3+OLYMPUS+trial&rank=1 ClinicalTrials.gov Identifier: NCT02793128

Please pay attention to 2 and 3, in particular. This inclusion criterion means Ta tumor stages, which basically account for 26%.

I will not go into further calculations, but this is the reason for my thesis in the previous article about a limited target group of patients for UGN-101.

As I stated earlier, long-term indicators (survival, recurrence) are also very important.

Conclusions

My conclusions are the same as they were before the release of recent data:

1) It is unlikely that UGN-102 can substitute SOC for NMIBC first-line treatment.

2) FDA approval of UGN-101 for the entire UTUC patient population seems to be impossible.

Disclosure: I/we have no positions in any stocks mentioned, but may initiate a short position in URGN over 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.

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