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Topic: Omeros Miscellaneous

from the 2020 10K
https://investor.omeros.com/static-file … 8fbefcd09d

Our collaborators at The New York State Psychiatric Institute have completed two Phase 2 clinical trials related to our PPARγ program. These studies evaluated a PPARγ agonist, alone or in combination with other agents,
for treatment of addiction to heroin and to nicotine. The published results of the heroin study demonstrated that, although not altering the reinforcing or positive subjective effects of heroin, the PPARγ agonist significantly reduced heroin craving and overall anxiety. The National Institute on Drug Abuse provided substantially all of the funding for these clinical trials and solely oversaw the conduct of these trials. We have the right or expect to be able to reference the data obtained from these studies for subsequent submissions to FDA and continue to retain all other rights in connection with the PPARγ program. We have also reported positive results (i.e., decreased cravings and protection of brain white matter) from a Phase 2 clinical trial conducted by an independent investigator evaluating the effects of a PPARγ agonist in patients with cocaine use disorder.
An investigator-sponsored study on the prevention of relapse following treatment of cocaine use disorder is expected
to begin enrolling in March 2021. The study is funded by the National Institute on Drug Abuse (“NIDA”).

Patent Assignment Agreement with Roberto Ciccocioppo, Ph.D. We acquired the patent applications and related
intellectual property rights for our PPARγ program in February 2009 from Roberto Ciccocioppo, Ph.D., of the Università di Camerino, Italy, pursuant to a patent assignment agreement.

PPARγ. We acquired the patent applications and related intellectual property rights for our PPARγ program in
February 2009 from Roberto Ciccocioppo, Ph.D. of the Università di Camerino, Italy, pursuant to a patent assignment agreement. In February 2011, we amended the agreement to include all intellectual property rights, including patent applications, related to nutraceuticals that increase PPARγ activity. Under the amended agreement, we have agreed to pay Dr. Ciccocioppo a low-single digit percentage royalty on net sales of any products that are covered by any patents that issue from the patent applications that we acquired from him. In addition, if we grant any third parties rights to manufacture, sell or distribute any such products, we must pay to Dr. Ciccocioppo a percentage of any associated fees we receive from such third parties in the range of low single-digits to low double-digits depending on the stage of development at which such rights are granted. We have also agreed to make total milestone payments of up to $3.8 million to Dr. Ciccocioppo upon the occurrence of certain development events, such as patient enrollment in a Phase 1 clinical trial and receipt of marketing approval of a product candidate covered by any patents that issue from the patent applications that we acquired from him. If we notify Dr. Ciccocioppo that we have abandoned all research and development and commercialization efforts related to the patent applications and intellectual property rights we acquired from him, Dr. Ciccocioppo has the right to repurchase those assets from us at a price equal to a double-digit percentage of our direct and indirect financial investments and expenditures in such assets. If he does not exercise his right to repurchase those assets within a limited period of time by paying the purchase price, we will have no further obligations to sell those assets to Dr. Ciccocioppo. The term of our agreement with Dr. Ciccocioppo ends when there are no longer any valid and enforceable patents related to the intellectual property rights we acquired from him, provided that either party may terminate the agreement earlier in case of an uncured breach by the other party. Under the terms of the agreement, we have agreed to pay a portion of the payments due to Dr. Ciccocioppo to the Università di Camerino without any increase to our payment obligations.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

I found a trial that used a PPARy drug plus standard of care for cocaine dependence, versus standard of care. It has results that seem to indicate the drug worked, but the N is not very large.

See it here:
https://www.clinicaltrials.gov/ct2/show … amp;rank=1

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

Addiction is probably harder to evaluate with small N since it's not like folks die or have obvious disease.

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Re: Omeros Miscellaneous

Yes, I am always more of a skeptic with addiction treatments, Had lots of friends in the science and treatment side (doing the treating... and some ex-addicts).

But this drug class has been around a long time and is unlikely to be a money maker for Omeros.

from WIKI

Pioglitazone
Trade names    Actos, others
AHFS/Drugs.com    Monograph
MedlinePlus    a699016
License data   
EU EMA: by INN
US DailyMed: Pioglitazone
US FDA: Actos
Pregnancy
category   
AU: B3
Routes of
administration    By mouth
Drug class    Thiazolidinedione
ATC code   
A10BG03 (WHO)

Legal status   
AU: S4 (Prescription only)
UK: POM (Prescription only)
US: ℞-only [1]
EU: Rx-only
In general: ℞ (Prescription only)
Pharmacokinetic data
Protein binding    >99%
Metabolism    liver (CYP2C8)
Elimination half-life    3–7 hours
Excretion    in bile
Chemical and physical data
Formula    C19H20N2O3S
Molar mass    356.44 g·mol−1
3D model (JSmol)   
Interactive image
Chirality    Racemic mixture
Melting point    183 to 184 °C (361 to 363 °F)
SMILES
InChI
  (verify)
Pioglitazone, sold under the brand name Actos among others, is an anti-diabetic medication used to treat type 2 diabetes.[2] It may be used with metformin, a sulfonylurea, or insulin.[2][3] Use is recommended together with exercise and diet.[3] It is not recommended in type 1 diabetes.[3] It is taken by mouth.[3]

Common side effects include headaches, muscle pains, inflammation of the throat, and swelling.[3] Serious side effects may include bladder cancer, low blood sugar, heart failure, and osteoporosis.[3][2] Use in not recommended in pregnancy or breastfeeding.[2] It is in the thiazolidinedione (TZD) class and works by improving sensitivity of tissues to insulin.[2]

Pioglitazone was patented in 1985, and came into medical use in 1999.[4] It is available as a generic medication.[2] In 2017, it was the 125th most commonly prescribed medication in the United States, with more than five million prescriptions.[5][6] It was withdrawn in France and Germany in 2011.[7][8][9]

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

I have been thinking about the BIG PICTURE for Omeros and thought I'd share some of those ideas, here.

As we all know, narsoplimab IS the KEY at this point.
It is the key to Greg building the large well-know company of his dreams.

It is the key to his potential Nobel Prize (or Schwaeble's) for developing all the important immunological therapies that require changes in Lectin Pathway function.

In the last Call, Greg revealed what had been logical before, but unsaid: Narso is potentially a treatment and cure for most forms of Kidney Disease, not just IgAN. Recall that the US bill for dialysis alone is about 9% of ALL Medicare spending.

Cardiovascular disease?
Yes, caused by endothelial injury.
Macular degeneration causing blindness? that too.
Alzheimers and strokes? blood vessels in the brain have endothelial linings like everywhere else.
Liver?

There is like a couple of football fields of endothelial lining in the organs and blood vessels of every person, and they cause problems if they are inflamed.

So how is Omeros going to have the time and money to get improved indications for all of these major health problems?

If Omidria partly finances TA-TMA and TA-TMA revenue + Omidria can fund IgAN and aHUS and OMS906 approvals by 2025 then revenue from these fund 5 more indications by 2030... GPR174 (and other cancer targets already identified) just sits there with the patents getting older and older.

And 2nd or 3rd generation of Narsoplimab in 2030 is still going to be limited sooner or later when the IP stranglehold on the Lectin pathway expires.

I ask myself, "If I were Greg, what would I do?"
And the answer is that I would try to do deals to raise a lot of money, expand the staff, and tackle more indications, faster, simultaneously.

The implication of this is that there must be deals to get that money, unless the share price is very high so that selling more shares becomes worthwhile.

The initial approval of the first narso indication makes the drug and MOA real to a lot of skeptics, as would better quality proof that narso saves the lives of critically ill CV19 patients (and prevents sequelae... keeping in mind that what kills people with CV19 IS Sequelae).

It would be delusional to bet on a deal until after the next deal.

Omeros has made deals, but they were always IN-licensing things to build the pipeline. Now Omeros needs to out-license collaborate, etc. to bring in money and get its intellectual property out earning money to finance rapid expansion.

Meanwhile, we see Management tending the trees and we have to guess Forest Management is not being ignored just because the most obvious indication (double entendre alert) is CV19 and that is making much slower progress than any of us had hoped.

Comments are welcomed

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

We don't know if Greg has had any discussions, substantive or otherwise, with any other companies re out-licensing.  At this point in time it should be clear to us that nothing in this regard is going to happen before Narso is approved, marketing underway, and money coming in.  But I won't hazard any guesses as to how many indications Narso will be approved for, at the start.  My point right here is that it should be obvious to us that Greg wants to prove to the world that he can and did bring Narsoplimab to the world, overcoming lots of hurdles.

THEN, and only then, will Greg (maybe, maybe not, we don't know) feel more inclined to do business as to a buy-in(s) from other companies.  MAYBE he will relax a little bit as to this possibility.  Remember, Greg's not getting any younger either, he's like the rest of us in that regard.  He's human; he grows a day older every single day.

I agree with the idea that out-licensing will be appropriate as soon as the Narsoplimab picture is a bit more clear.  It will be better for patients and potential patients who might and will benefit from Omeros' drugs that still need to undergo further development and trials in order to be useful medicine to treat people who need that treatment.

If time was not a factor re our own age, and Greg's age, and the need for good treatment regimens right now, then I assume the most money would be made by keeping everything in house forever.  But time is a very important factor in two ways.  First, we are all getting older.  How long should we wait for a reasonable payoff here?  Second, the world needs Omeros' pipeline drugs in service, right now - assuming they will pan out.  I'm saying there must be a balance between maximizing income and minimizing the amount of time necessary before the pipeline drugs can be brought to market.

Out-licensing is in order, given the depth of the Omeros pipeline, which is too large to completely handle in-house.

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Re: Omeros Miscellaneous

Given the push on OMS174, PR-wise, about a year ago, I think  Greg was marketing in search of a partner. We have NO idea if he has talked with anyone interested.

He has told me he is in favor of out-licensing or outright sale, if the deal is good... and that includes Omidria. I seem to recall a price range that I thought a bit low at the time, but I may be wrong... anyway, he had little chance of selling Omidria without reimbursement. NOW he has a chance, but a better price will be available if NOPAIN is approved or if CMS continues to give separate reimbursement past 2021.

The highest price will come from NOPAIN passing because that will help pricing in hospital lens replacements.

Omeros has in-licensed, and a partner on the PPARy (OMS405) anti-addiction drug being tested in cocaine addiction. IMO low likelihood of becoming commercial but costing OMER nothing.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

The lack of information (that should not be given out) allows unrealistic investors who are weak on due diligence talk up their own and other's expectations.  Here are some example relating to an important topic, which has a large effect on research and choices of what indication to seek.

THE PRICE OF NARSOPLIMAB


Poster 1:
10,000 cases yearly in US and EU. No other treatments available. What is 8000x 400k. I believe it is 3.2

Poster 2:
How much do we charge. 200k and the world hates us. 20k and we make no money unless gov pays for all manufacturing and buys a large block to seed sales.

That i why I hope the vaccines work and leave only a few that need Narso we can charge orphan pricing then.

Poster 3:
Thats the question. I believe it will be a last resort drug to save critically ill patients if it happens. Governments will purchase supply orphan pricing will be acceptable in these circumstances. If trial results are really dramatic and when given earlier in illness it almost eliminates mortality and after effects at that point I believe Omeros has to reconsider the future of narso. And given its likely useful with so many other illnesses this is a viable path forward with much much lower pricing.
***********************************

We are in the dark about how much narso is needed to treat each patient. But we know that depending upon the disease, it lasts for different amounts of time.
aHUS lasts years...until the patient dies.
CV19 treatment is over in an average of 2 or 3 weeks.

If aHUS patients us 15 times the amount of narso in a year than CV19 patients, the drug used will cost 15 times as much.

Soliris now costs about $450k/yr for aHUS. For simplicity, say it costs $520,000 or $10,000/week.

To buy enough narso to treat the average CV19 patient, it would be $20k to $30k.

If TA-TMA patients were treated for 13 weeks, the average would spend $130,000 on narso... if narso was priced at $520,000 a year for people with aHUS.

The numbers above are NOT accurate, that makes no difference because it is the concept that I am showing you.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

When does Omer need to formally establish pricing?  I assume after approval, and even then it can remain confidential between Omer and the insurance companies, but would need to be public for sale to the government.  I would guess though that Omer would disclose to the investment banks so that the could model revenues based on disease category, dosing and duration assumptions, etc, as you mention.

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Re: Omeros Miscellaneous

Good question and I think you answered it too.
Partly.

I don't recall Omeros ever putting out price information on Omidria. But we know the price CMS has approved and the CMS price policy (based upon average price charged). Thus the medicare-mandated price changes with the average price.

You will also note that Omeros divulges total revenue and total cost of goods sold in 10K and Q filings but never a price.

Some companies do divulge prices. And you can google drugs and get their price...at least the price charged at a Pharmacy. The companies that repeatedly raise their prices divulge theirs, in one way or another, though they'd probably prefer to keep them secret.

I expect that Omeros will divulge the price to treat the average patient, by indication, which is what interests investors, but they may just divulge the price per milliliter.

And if narso is first approved for TA-TMA, they may set the price and then change that price when the drug is approved for the next indication.

TA-TMA is the indication of the three that takes the least narso to treat each patient, and for the shortest duration. aHUS, scheduled to be third to approval, takes the longest (all year, every year) treatment and the MOST drug.

It may not be a coincidence that the order of approval will be TMA, IgAN, aHUS......and that CV19 is a wild card that was never in the plan and is complicating the plan.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

Yes, I would not bet against Greg being very strategic, or calculating, in the order being pursued based on amount used.  He would have full information on manufacturing costs leading into that decision making.

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Re: Omeros Miscellaneous

I don't think manufacturing cost was the crucial factor, given the apparent choice to address only orphan-drug status indications first.

He could have gone for cardiovascular disease first, and try to supplant the use of statins, for example. He strategically look for life-saving treatments for things that had no treatment for fatal illnesses or no safe/convenient treatment that was a known money maker, like aHUS.

Given Soliris is another mab drug, he likely was very familiar with ALXN Cost of Goods Sold and what they charged.

Remember the average Major Pharma Gross Margin is about 70%. Actually, writing this makes me want to access an early ALXN 10Q and look at gross revenue and COGS for Soliris after its first approval....

It may be interesting.
Stay tuned.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

OMS 527 is supposed to work for a variety of drugs, not just smoking.
Generic copies of successful Chantix are due soon, but these drugs don't work for the majority of the people who try them.
Something that works better will sell.

"Some of the pessimism around the (PFE) stock is because two of Pfizer’s top drugs are amid patent expiration. Chantix – a prescription drug that helps smokers quit smoking and that generated sales of $919m in last year had its US patent expire last year with the European equivalent expiring this year."
https://seekingalpha.com/article/443624 … investment

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Omeros Miscellaneous

good for OMS527

Pfizer halts global distribution of Chantix due to cancer causing agents
Jun. 24, 2021 3:29 PM ETPfizer Inc. (PFE)By: Dulan Lokuwithana, SA News Editor1 Comment
Pfizer Makes $1.95 Billion Deal With U.S. For Future COVID-19 Vaccine
Jeenah Moon/Getty Images News
Citing potential carcinogenic substances in certain lots, Pfizer (PFE +0.3%) has halted the worldwide distribution of smoking cessation pill CHANTIX (varenicline) last month, Stat News reports.
The company is reportedly investigating after detecting nitrosamine levels above the “acceptable” daily intake. Regulators in South Korea have issued recall notices for the treatment.
“We believe the benefits (of the drug) outweigh the very low potential risks, if any, posed by nitrosamine exposure… on top of other common sources over a lifetime,” a Pfizer spokesperson told Stat.
“We have worked hand-in-hand with regulatory authorities around the world who are taking varying approaches and have varying timelines.”
In 2020, CHANTIX also known as Champix generated $919M in sales for the company indicating a ~17.0% YoY decline and contributing ~2.2% to the topline.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.