Seelos Therapeutics (SEEL)

FN Rating

9.5/10
9.5/10

FN Summary: Lead asset (SLS-002) has Fast Track Status and is in P2 (Registrational Trial) testing for Suicide behavior and Major Depressive Disorders. This is a huge unmet medical need which represents a $3B US market. P2 results are due (hopefully) by summer 2022.

Table of Contents

This company hits most the right spots!

Experienced Management

Fast Track Status for Lead Drug

Good Phase 2

Recent Insider Buying

Decent Cash (as of Dec 2021)

SP at all 12 month low (as of Jan 2022)

X

Next Catalyst

Completion of Phase 2 (registrational trial) enrollment ~ 2nd Q 2022
.
Countdown Timer 👇
days until Apr 1
Anticipated Registrational Trial Enrollment Completion

Interactive Chart

Catalyst-Chart Overlay

Caveat! Stock movement can be very finicky and, at times, seemingly random. This is FN's best explanation of the price movement.

May 7 - IPO

March 2020 - Covdid-19 affected all US equities negatively)

July 13, 2020 - DMC recommends increasing sample size from 240 to 360

Cash on Hand

.

Est Monthly Cash Burn

$$$$

78M

4M

Notes

nice cushion...

.

Est Cash End of Mar 2022

66M

Enough cash until SLS-002 Registrational Trial Results

Pipeline

Products & Sales Potential

Product

Indication

Acute Suicide Ideation & Behavior

US Market

1M cases

Global Market

For Context: Seelos Tx Market Cap ~ $91M as of Apr 8, 2022

Management

Yes, we know. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management

Company PDFs

Read all of this 👇

Corp Presentation - Apr 2022

Phase 2 Clinical Trial

Normally we list information for the Phase 2 and Phase 3 trial. However, SEEL just finished the 1st part of the Phase 2 trial. It was a huge success. SEEL received approval from the FDA to have the 2nd part be a registrational trial.

Understanding the 1st part of the Phase 2 trial is crucial to anticipate the success of the current 2nd part of the Phase 2 trial. In summary, the 1st part of the Phase 2 trial was a huge success.

The 1st part of Phase 2 was open label and easily meet its primary and secondary endpoints.

Phase 2 - Part 1 also had excellent safety.

In July 2021 the FDA agreed with SEEL that the 2nd part of the Phase 2 trial could be a registrational trial. This means they can take use the results for an NDA.

This is exactly what we like to see in a registrational trial - a design almost identical to the previous Phase. This reduces the chance of unknown variables entering the trial (although it is still possible).

Analyst Price Targets

Analyst Price Target History

One year ago 1 analysts had a Buy rating with a $12 price target. Now the company is closer than ever to finishing their first registrational trial and the SP has dropped significantly, and analysists have noticed. Now 5 cover the stock with a buy rating.

Ownership

Insider Ownership % (not precise)

Insider Transactions

Unfortunately, there have been no insider buys recently (12-18 months). Considering the SP is near a 1 year low, it would be nice to see.

Institutional Holdings

This is an average amount of institutional ownership.

Notable Institutional Holdings (as of 9/30/21)

Short Interest

Daily Short Volume Chart

Shares Available to Short

Sign up for Seelos Therapeutics emails! If you invest in this company, this is not optional.

You must stay updated on every development.

Best SEEL Seeking Alpha Article

Yes, we read them all and this is the best one if you are short on time. But serious FN investors read all of them.  🙂

Q. What is the anticipated cost for SLS-002?
A. We believe he cost to be around $5K since JNJ Spravato’s drug is ~$5.8K.

Risks

Phase 3 was slowed as hospitals focused exclusively on Covid patients. It is possible that a data variation was created which will adversely affect the results.

Phase 3 pulls in a much larger group of patients. Anytime this occurs, new variables can be introduced that Phase 2 did not uncover. These variables can cause adverse results resulting in the company not hitting their endpoints.

This drug (ketamine) has been available for a long time (just not for ASIB or MDD); therefore, the patent has run out. SEEL, or whomever buys the company, will have a short window (3-yrs) of exclusivity since the market is very large (>800,000 patients).

Competition

The only approved drug for suicide patients in the ER is JNJ’s Spravato. Many current treatments for Acute Suicide Ideation Behavior (ASIB) include hospitalization and/or anti-depressants – many with a black box warning as they can lead to increase in suicidal thoughts.

Email us at info@frugalnorwegian.com if you have more.  We want to list all risk factors for the drug & trial.

Have questions about this info? Did we miss a fact? We want to hear from you.

Like this page? Share and show others how smart you are. 🧠

Share on facebook
Facebook
Share on twitter
Twitter
Share on linkedin
LinkedIn
Share on reddit
Reddit
Share on email
Email