Biotech Analysis Central Preview Series: Kadmon Holdings, Inc.
Long Only, Biotech, Healthcare, Short Only
Seeking Alpha Analyst Since 2011
I am the Founder of Biotech Analysis Central, A subscription service on Seeking Alpha's Marketplace. If you want to learn more about biotech investing or you want to check out my biotech analysis you can do so with a free 2-week trial to my service. Just hit the "Learn More" button on the bottom of the Marketplace Research Tab. I have a Bachelors of Applied Science Degree In Technology Management, Industrial and Business Services Management from St. Petersburg College Florida. I have been investing in biotech stocks for many years, and I prefer to invest as a long term investor. With that In mind I seek stocks that have long term value! I primarily Like to Invest In biotechnology stocks and I accept the risks. I Write for the Healthcare Sector and Stock market in general. I contribute to Seeking Alpha.
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This is a preview blog series on what you can expect when subscribing to my "Biotech Analysis Central" service marketplace. For the full article you must subscribe to my service. This is just an intro of two snippets on the research articles that are written. Thus far, there are about 300+ research reports on both both small-cap and mid-cap biotech stocks with full analysis of the pipeline, catalysts, financials, and clinical trial analysis. If you want to read more then please subscribe to my marketplace service. As always I offer a 2-week free trial just to show you how helpful my service is. You can cancel anytime before the 2-week free trial is up and never be charged a dime.
First Section Of Marketplace Article (This article piece was originally written on November 20, 2020)
The next article I wanted to discuss for the "Biotech Analysis Central Stock Insight Series" is a biotech by the name of Kadmon Holdings, Inc. (KDMN). The reason why I want to go over this biotech next is because I believe it can offer investors some upside potential. Specifically, the treatment Belumosudil (KD025) has already met the primary endpoint of a pivotal study treating patients with chronic Graft-Versus-Host-Disease ((cGvHD)). The good news is that a New drug Application (NDA) had already been submitted for this drug back in September 30, 2020. Not only that, but as I will explain below this NDA is part of the FDA's new review program known as Real-Time Oncology Review (RTOR). The bottom-line is that this program is trying to get new safer treatment alternatives to patients as quickly as possible with a speedier review as opposed to normal FDA applications taking a long time. Even though the primary endpoint has already been reported, the biotech expects to report additional updated 12-month data from the ROCKstar pivotal trial at the American Society of Hematology (ASH) Annual Meeting expected to take place on Sunday, December 6, 2020, 9:30am - 11:00am PT . That will be newly updated data so there might be new interest based on it. On top of that, it is also looking to give an update on the possibility of getting Belumodudil approved in Europe as well. An Update on this is expected to happen in the 1st half of 2021, and will be another catalyst for this program. Kadmon is also looking at expanding the use of Belumodudil for the treatment of patients with systemic sclerosis ((SSc)) as well. A phase 2 placebo controlled study is ongoing and an open-label study will be started in Q1 of 2021. Lastly, the company is working on a new drug product known as KD033. This may end up being a really good product because it is a mix of an anti-PD-1 drug and also targets IL-15. KD033 is a fusion protein drug, which may have potential with two targeting effects. The market cap is pretty steep at $730 million, but several drugs in the pipeline have the potential to target large markets. The cGVHD, the first indication, starts out at targeting a roughly $600+ million market. A good start, and it will be important to see if other programs advance forward.
Conclusion Of Marketplace Article
The Final Verdict is that Kadmon Holdings is a good buy. I don't view this biotech as being speculative based on the main indication of treating patients with cGvHD. There is no guarantee that Belumosudil will be approved by the FDA. However, the response rates observed above range from 64% with once daily dosing of drug to about 67% with twice daily dosing. If the data to be presented at the upcoming ASH meeting also exceeds expectations on all secondary endpoints, then that may pretty much seal the deal on FDA approval. All is needed normally for FDA approval is the primary endpoint. However, if there is improvement in overall survival and other important endpoints that makes the case for approval even more necessary. It is expected that the global graft versus host disease market could reach $640 million by 2026. As far as the other indications go, it is important to track those especially. That's because they are both multi-billion dollar markets. It is expected that the global systemic sclerosis market could reach $3.8 billion by 2026. As far as the clinical product KD033 goes, it could be worth the most because of the fact it is a mix of an anti-PD-L1/IL-15 fusion protein drug. As you know anti-PD-L1 drugs in the cancer market are generating billions in revenue. It's important to note that KD033 thus far is only in a phase 1 part 2 dose escalation study for the time being. If and once the released results provide proof of concept in treating patients with advanced solid tumors, that adds an additional component to the pipeline. The market cap is pretty high, but if the catalysts above turn out to be positive, then I can still see some upside in the stock. Especially some of the analysts I noted above. They believe on average the stock price could reach about $10 per share based on current pipeline progress.
Analyst's Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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