Omeros Corp (OMER)
FN Investment Rating
8.5/10
8.5/10
FN Summary: Omeros has 2 breakthrough therapy designations for their lead asset (Narsoplimab). Narso is currently awaiting PDUFA for HSCT-TMA, which should occur on Oct 17, 2021. Narso for IgAN (very large market) is currently in a P3 trial, but not expecting results until 2023. Company has a history of taking a long time to complete clinical trials. If PDUFA is granted, company is a prime candidate for a buyout. Good cash until next catalyst.
Table of Contents
This company hits all the right spots!
Experienced Management
High Institutional Ownership
Outstanding P2 & P3 Trial (for HSCT-TMA)
Several Drugs in Clinical Trials
Good Cash Reserves
Huge Market
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Countdown Timer 👇
days until Oct 17
PDUFA Here
Next Omeros Presentation
None Scheduled
P3 readout any day!
Interactive Chart
Cash on Hand
$$$$
126M
12M
Est Cash End of May 2021
100M
will not need to raise cash before Oct 17, 2021 PDUFA
Pipeline & Timeline
Products & Sales Potential
Indication
HSCT-TMA
IgAN
aHUS
ROW Market
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Omeros Market Cap: ~ $1B as of June 4, 2021
Management
Yes, we get it. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
- Founded the company and has served as our president, chief executive officer, and chairman of the board of directors since June 1994. Prior to founding Omeros, Dr Demopulos completed his residency in orthopedic surgery at Stanford University and his fellowship training in hand and microvascular surgery at Duke University. Dr Demopulos currently serves on the board of trustees of the Smead Funds Trust, an open-end mutual fund company registered under the Investment Company Act of 1940. Dr Demopulos received his MD from the Stanford University School of Medicine and his BS from Stanford University.
- George A. Gaitanaris, MD, PhD, joined Omeros as our vice president, science in August 2006 and has served as our chief scientific officer since January 2012. From August 2003 to our acquisition of nura, Inc. in August 2006, Dr Gaitanaris served as the chief scientific officer of nura, a company that he co-founded and that developed treatments for central nervous system disorders.
- From 2000 to 2003, he served as president and chief scientific officer of Primal, Inc., a biotechnology company that was acquired by nura in 2003. Prior to co-founding Primal, he served as staff scientist at the National Cancer Institute.
Clinical Trials
Narsoplimab for HSCT-TMA
Currently awaiting PDUFA decision which is due on Oct, 17, 2021. Here are the overall response rates for that trial.
The chart below shows the patient survival vs. time for treated patients. Patient survival is the gold standard for the FDA.
Narsoplimab for IgAN
Understanding the Phase 2 trial is crucial to anticipate the success of the current Phase 3 trial.
Here is an overview of the Phase 2 Clinical Trial. The results were very good.
With these results in hand, Omeros worked with the FDA to design the Phase 3 trial, which is currently in progress. The trial design is shown below.
FN Takeaway: Narsoplimab is a pipeline in a drug. It is addressing unmet medical needs in hard to treat conditions.
Company PDFs
(FN posts only the most recent documentation)
Read all of this 👇
Corp Presentation - April 2021
Ownership
Insider Ownership % (not precise)
Insider Transactions
While there has been some insider selling, it is a very low % of their overall holdings.
Institutional Holdings
Notable Institutional Ownership
Additional Info
OMER Discussion Forums (listed in order of best DD potential)
Sign up for Omeros emails! If you invest in this company, this is not optional.
You must stay updated on every development.
OMER Videos
We don't include TA videos - sorry, not sorry
Most Recent Video - May 18, 2021
Additional Omersos Videos
OMER Playlist
6 Videos
Risks
The share price has gone sideways (with volatilely) for the last several years. Some have criticized management as being to optimistic on their timelines.
It is possible that the upcoming PDUFA results in a CRL from the FDA. The FDA did request additional information from Omeros on May 20. This resulted in a 3 month delay in PDUFA. This is not seen as a negative by management but hopefully the additional info addresses their questions.
Phase 3 for IgAN was put on a complete pause as hospitals focused exclusively on Covid patients. It is possible that a data variation was created which will adversely affect the results.
Phase 3 for IgaN 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.
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.
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