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Biotech Analysis Central Preview Series: Lipocine Inc.

Sep. 08, 2021 6:25 PM ETLipocine Inc. (LPCN)
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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 August 28, 2021)

The next article I wanted to discuss for the "Biotech Analysis Central Stock Insight Series" is a biotech by the name of Lipocine Inc. (LPCN). The reason why I want to go over this biotech next is because I believe it has massive potential based on its recently released positive results from a phase 2 study using LPCN1144 for the treatment of patients with non-alcoholic steatohepatitis (NASH). With these positive results the company will meet with the FDA. There are two options, potential for accelerated approval pathway or the need to run a phase 3 confirmatory study. Another reason why I think this is a good biotech to look into is because the company has received tentative FDA approval for a drug by the name of TLANDO. Tentative, in that it has met all the requirements but there is a patent dispute with Clarus Therapeutics which has standing until March of 2022. I believe if Lipocine can clear up this and get TLANDO to market, that could be another positive for the biotech. Besides that, it has several other drugs in the pipeline being explored for other indications like: Depression disorder, cirrhosis and preterm Birth. With proof of concept established in NASH, plus several other potential catalysts, I believe it is a good speculative biotech bet. Especially, since the stock only trades at $1.40 per share.

Conclusion Of Marketplace Article

The Final Verdict is that Lipocine Inc. is a good speculative biotech to look into. As I noted above, TLANDO seems to have a shot at being approved by the FDA for Hypogonadism by March of 2022. However, the company has to get some things in order with the FDA like post-marketing studies and possibly other application issues. It is a good market for the biotech though, because it is said that the global Hypogonadism market could reach $3.233 billion by 2023. In addition, the proof of concept data from the LIFT study is encouraging in that NASH patients who took LPCN1144 saw a statistically significant reduction of liver fat content on the primary endpoint of the study. However, confirmation is going to be needed in a larger study with more patients. Still, Lipocine has a shot at targeting this large multi-billion dollar market based on its recent data. It is estimated that the global NASH market could be worth $20 billion by 2027. Besides these programs the biotech has LPCN1154 for treatment of postpartum depression and LPCN1148 for the treatment of cirrhosis. Both of these indications are going to have phase 2 proof of concept studies starting soon in the 2nd half of 2021. These are additional shots on goal that could help the biotech boost its value. The risk is that this stock trades at only $1.33 per share. Therefore, it is close to being under $1 per share so keep that in mind. There is no guarantee that it will stay above that price and it's quite possible later on a reverse stock split could be necessary upon any progress being hindered for any particular reason. That's why I believe it might be worth it as a speculative bet.

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours.

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