1

Topic: OMER Comparators, Competitors, VALUATION & potential partners

This new one ANNX was listed today WITH A HIGHER MARKET CAP THAN OMEROS. They have no revenue r approved product but they have $370M cash (about twice the cash of OMER).

Yahoo wrote:

Annexon, Inc., a clinical-stage biopharmaceutical company, discovers and develops therapeutics for autoimmune and neurodegenerative diseases. It focuses on the treatment of body, brain, and eye disorders. The company's C1q is an initiating molecule of the classical complement pathway that targets distinct disease processes, such as antibody-mediated autoimmune disease and complement-mediated neurodegeneration. Its product candidates include ANX005, which has completed Phase 1b clinical trials to treat patients with guillain- barré syndrome; and ANX007, which has completed Phase 1b clinical trials to treat patients with glaucoma. The company's candidates also comprise ANX005 that has completed preclinical trials to treat patients with warm autoimmune hemolytic anemia, Huntington's disease, and amyotrophic lateral sclerosis; ANX007, which has completed preclinical trials for the treatment of geographic atrophy; and ANX009 that has completed preclinical trials for the treatment of systemic autoimmune diseases. The company was founded in 2011 and is headquartered in South San Francisco, California.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AstraZeneca buying Alexion in $39B cash and stock deal
Dec. 12, 2020 8:25 AM ETAlexion Pharmaceuticals, Inc. (ALXN)By: Stephen Alpher, SA News Editor12 Comments
Alexion (NASDAQ:ALXN) owners will receive $60 per share in cash and 2.1243 ADS of AstraZeneca (NASDAQ:AZN) for each share of Alexion they own. Based on AZN's recent closing price, that implies a deal value of $39B, or $175 per share. That's about a 45% premium to Alexion's close on Friday.
Alexion's leading expertise in complement biology will accelerate AstraZeneca's growing presence in immunology, say the companies. The deal is expected to be immediately accretive to core earnings.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Timing is good for ALXN in that they probably saws a challenging future for their cash cows given OMER and perhaps others getting into Complement space

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Yes, hard to believe AZN is too dumb to wait 2 years and pay half price... unless AZN has other acquisitions in mind to dominate compliment.

Please note that BAC advised ALXN and JPM advised AZN, while both BAC and JPM are not, at least nominally involved with Omeros.

BAC and JPM also are involved in the financing of the deal which means they know what AZN plans, at least roughly... and they know what Omeros plans.

These investment banks are the Dons in a Organized Crime Supreme Council. They have made money on ALXN and, given its immanent decline, they have arranged to sell it at a profit to AZN.

Now the can focus more on new fighters, building them up by giving them easy opponents, with big paydays for everyone involved.

Hopefully the Omeros financing was the tipoff that the fix is in, and the close above the recent financing price means that the launch is about to happen.

I can hope this is how it will, go, at least.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

This approval is an indication that narsoplimab was tested for in the Phase 2 basket trial that gave rise to the HSCT-TMA data that became the pivotal trial and BLA.

I note that Omeros has not followed up with more treatment of people with Lupus Nehpritis.
from STAT:
=================================
GSK drug approved for lupus nephritis

The FDA has approved a new therapy to treat lupus nephritis, a kidney disease linked to the autoimmune condition. The monoclonal antibody, called Benlysta, was developed by GlaxoSmithKline and has been approved to treat lupus generally since 2011.

Built into Benlysta’s original FDA approval was a provision that the drug be tested in lupus patients with kidney disease, given that up to 60 percent of people with the disease will develop lupus nephritis.

The current standard of care for lupus nephritis involves large doses of strong immunosuppressant drugs, like corticosteroids.

“These medications can take a considerable toll on the body,” Dr. Susan Manzi, chair of the board for the Lupus Foundation of America, said in a statement. Benlysta, she said, “has a favorable safety profile while delivering results with less risk from the side effects associated with legacy lupus nephritis treatments.”

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I suppose we can assume that narso was either more effective for TMA, or that the lupus market opportunity is either smaller or has more competition, thereby making TMA a preferred initial target

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I think lupus nephritis has MORE patients than HSCT-TMA.

I have not discussed this with Greg, so I can only guess that for some reason, he thought HSCT-TMA was better.

I can imagine a number of reasons why.

- no approved drug
- no drug (at the time) being trialed for the indication
- clear cut endpoint
- orphan indication
- high cost of ineffective treatment means narso price could be high
- focus on kidney was to be on strongest data, which was IgAN which would (I presume) be easier because proteinuria was approved as primary endpoint, making extending to Lupus Nehphritis easier as a second indication.

These tactical decisions could be complication,and I (of course) am just guessing.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Failed Primary Endpoint.
will it get approval for what the company considered secondary?
===========================
VFMCRP and ChemoCentryx Provide Topline Results From ACCOLADE Trial of Avacopan in C3 Glomerulopathy Including Improved Estimated Glomerular Filtration Rate (eGFR)
As in ANCA vasculitis, avacopan demonstrated statistically significant improvement in renal function as measured by eGFR compared to placebo over 26 weeks of blinded treatment
The change from baseline to week 26 in C3 glomerulopathy histologic index (C3G HI) for disease activity (primary endpoint) was not statistically different between the two treatment groups, while the C3G HI for disease chronicity (measuring progression of fibrosis) shows significant benefit for avacopan versus placebo
Avacopan safe and well tolerated in C3G patients
ChemoCentryx and VFMCRP plan to discuss registration pathway with regulatory agencies in US and EU

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

January 7, 2021 11:17 AM EST Financing
Kira and its complement-target inhibitors plot run to the clinic with new investor cash just months after uncloaking
Nicole DeFeudis
Associate Editor
A couple months after emerging from stealth, Kira Pharmaceuticals has reeled in its largest venture round yet to fund a dash to the clinic.

The startup, co-founded back in 2017 by University of Pennsylvania professor Wenchao Song, hooked $53.5 million in what it calls a “Series B+” financing. It burst onto the scene in November, with $18 million in Series A winnings and $28 million from a Series B raised in stealth. With former Sienna Biopharmaceuticals CEO Frederick Beddingfield at the helm, the team is on a mission to put three complement-targeted therapies in the clinic over the next 18 months.

“While the complement system has historically been difficult to target given its complexity, we believe our LOGIC drug discovery platform enables us to approach complement mediation in new and different ways, unlocking transformative therapies for patients,” Beddingfield said in a statement.

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The complement cascade, a part of the innate immune system, is “great when it’s working well,” the CEO told Endpoints News in November. But dysregulation can lead to autoimmune disorders. Depending on that dysregulation, blocking certain parts of the pathways that activate the complement system can be “quite effective” in controlling disease, he added.

Kira’s lead candidate, P014, is designed to inhibit both upstream and downstream complement targets. It’s engineered with an extended half-life and potency, and has the potential to be self-administered at home. While the team is looking to improve on the standard of care in some diseases, Beddingfield told Endpoints in November that they’re more interested in treating diseases for which there are no complement drugs currently approved.

“Our bigger goal is to treat diseases where there’s really a completely unmet need,” he said.

The company is keeping mum about its other programs, which are “in development to treat a range of immune-inflammatory diseases and cancers in the US, Asia and other global markets,” according to its website. In addition to its Cambridge, MA headquarters, Kira boasts a Suzhou, China R&D center.

Prior to joining Kira, Beddingfield left his perch at Sienna in December 2019 — a few months after the biotech filed for bankruptcy. Sienna’s stock never quite recovered from the failure of its experimental acne drug SNA-001, which flopped in two separate trials testing its efficacy when managed by laser tech. The CEO was planning to take some time off when he got a call from Song — and the rest is history.

Once it lands in the clinic, Kira may have some catching up to do. Alexion snagged its second approval for the complement therapy Ultomiris last year, which is now OK’d to treat atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AUPH up over $5/share in premarket after its drug approval.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

smile
shoulda bought more!

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Congrats anyway!

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

January 25, 2021 10:52 AM EST PharmaManufacturing
Lonza looking to build on 'differentiated advantage' in Covid-19, CDMO marketplace in 2021
Conner Mitchell
Associate Editor
It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.


Pierre-Alain Ruffieux
In an exclusive interview with Endpoints News, Lonza’s CCO Jean-Christophe Hyvert said the company has no plans to slow down anytime soon.

“A big piece of the activity has been surrounded around Covid, both in terms of supporting clients when we can, and when we have a differentiated advantage in the COVID development effort,” Hyvert said. “And we do that across multiple clients.”

Lonza’s footprint in Covid-19 therapeutics goes beyond the Moderna vaccine agreement. The company has received some 200 inquiries from biotechs across the globe and has public deals with five other companies for varying treatment possibilities.

Beyond Covid-19, Hyvert said Lonza’s focus in 2021 and beyond will be on ensuring its operations are up-to-date with the burgeoning manufacturing industry. Those industry trends, he said, are driven by a market that centers on a pipeline of strong new drug candidates and an increasing global presence within that pipeline.

“The pipeline of new drugs is very strong, and the pipeline of new drugs is becoming more and more global,” Hyvert said. “So we are evolving in terms of more drugs coming from different geographies, in terms of … more formats, (and) in terms of the speed to development and delivery is increasing. We need to respond to all of that, and that’s what we are doing.”

Tangible examples of that response have come in recent months, perhaps most notably through Lonza’s acquisition of its first biologics manufacturing in China as part of a deal with Cytiva, announced just two weeks ago. The nearly 183,000-square-foot site includes nearly 70,000-square feet of lab space that will prioritize antibody development and manufacturing services.

And in December, Lonza announced six different manufacturing and development collaborations with various biotech outfits, as well as a Visp, Switzerland expansion that will boost its production capacity by 30% by the first half of 2022.

“We are expanding in China, especially on the biologics side. We’ve been in the country for a few years, but we do believe there is a very strong potential in China,” Hyvert said. “(This) will provide us a very comprehensive, real-world coverage with clinical and commercial capabilities in … the Americas, Europe and Asia, so that’s part of what we are doing. And at the same time, I think it’s important to note that we are developing the breadth of our offerings in terms of modalities.”

That expansion of client-offerings seems to be three-tiered: microbial therapeutics, mRNA technologies, and bioconjugation. The Visp expansions also seem to be the center of all three of these focuses, as they touch on microbial development, while housing production sites for the Moderna Covid-19 vaccine that uses mRNA technology, and finally focusing bioconjugation efforts to make more complex protein therapies.

“I think we have a unique offering that helps both large pharma and small biotech with either their development needs or manufacturing needs,” Hyvert said. “We are solving more and more complex problems for our clients, and I see that as being very well received in the marketplace.”

Going forward, Hyvert said he expects the current market trends of a strong drug pipeline with a global focus to stick around. Lonza’s role, then, will be to continuously respond and adapt to those trends to ensure its services stay relevant and effective.

“I think we need to keep on building on what differentiates us, which is technical expertise, reliability, know-how, a wide range of offerings to respond to needs, our understanding of regulation and markets to respond to costs, or to help customers to bring their drugs to market,” Hyvert said. “I think these fundamental trends are not changing, (so) I think the way we are addressing them will be more and more important.”

Here are Lonza’s Covid-19 deals to keep an eye on:

Molecule: CAP-1002, cell therapy candidate with Capricor for treating Duchenne Muscular Dystrophy and complications arising from COVID-19, treatment
Intranasal vaccine: AdCOVID with Altimmune
Vaccine: Moderna Covid-19 vaccine, previously known as mRNA-1273
Molecule: AZD7442 with AstraZeneca, a combination of two long-acting antibodies
Therapy: Lenzilumab anti-human granulocyte macrophage-colony stimulating factor, with Humanigen
Molecule: Licensing agreement for JS016, a GS Xceed Expression System with Junshi Biosciences

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Interesting.  Lonza ia OMER's unmentioned narso supplier.

I talked to my bioreactor contact over the weekend.  He says he is very busy, as are all bioreactor companies but they're keeping up with orders.  Not a backlog yet, but it still takes about a year to build/activate/certify a bioreactor setup.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Perhaps failed vaccines will not need the space they booked?

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Hopefully it will take less than a year to scale up a smallish bioreactor to a much large bioreactor

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Re: OMER Comparators, Competitors, VALUATION & potential partners

There is only 2, I understand.
2,000L
20,000L

Nothing in between.

I am told that for the right price and important enough drug it can be done in less than 6 months, but who knows in this high-demand period when the drug-makers are expanding. They may still be attractive businesses, given the potential long-term business from this and potentially other viruses.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I we, and perhaps the world at large, are lucky, OMER has already been working on this for many months with Lonza and the government.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

We hope they have done more than just talk.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Alan Robert Ross wrote:

There is only 2, I understand.
2,000L
20,000L

Nothing in between.

Multiple sizes between 2k and 20k are being built.  None larger that I'm aware of.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

20,000 liters = 5,283.44 gallons.  My diesel fuel tank at the fish site is 1,000 gallons.  It sits inside a 1,400 gallon containment tank.  5K gallons isn't a whole lot.  Is the Narsoplimab coming out of the reactor dosed straight-up, or is it diluted in any way?  I could see some thousands of doses coming out of a 5,000 gallon tank, maybe 10's or a couple 100 thousands perhaps.  But millions of doses?  Tens of millions of doses?  No way.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I'd have to go back and look but my recollection is that I was told the bioreactors produce a couple of percent by volume of the desired products. If true, that'd be (roughly) 40 liters from a 2000L reactor and 400L from a 20,000L one.

My guess is that narso is coming from 2000L reactors so far.

40L = 40,000 ccs, and as far as I know, we have NO idea what a narso "course of treatment" consumes/patient for TMA or any of the other therapies.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

That's pretty interesting.  40,000 ccs from a 5K liter reactor - that's something I suppose, but still not much in terms of anticipated general need.  So most likely 160,000 ccs from the 20K liter reactor.  And we want to see world-wide distribution of Narso, right?  Well, my thought is if the stock market looks about 6 months ahead (what we often read in terms of the general market but possibly not the usual anticipation re an individual stock), the time schedules, so to speak, seem to mesh nicely for us.  Assuming Omeros locks up the bioreactor production, well, the truth is I don't know what I'm talking about.  I think we may need a whole lot more Narsoplimab than what we have available.  Alan has spoken to this issue before.  A good problem to have I suppose, particularly if the Government is willing to help speed things along....I'm trying to look ahead to anticipate problems that people (shorts) can use to knock the price of Omeros stock down.  It doesn't seem reasonable to think that OMER will not be helped in one way or another re narso production, if it's as good as we think it is.  I think it's more reasonable to think that OMER will be helped re producing enough Narsoplimab, because these days it could be considered a basic human need.  Like good food and clean water and shelter.....I guess we'll find out how much that is worth.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

alaskasalmonfisher wrote:

I think it's more reasonable to think that OMER will be helped re producing enough Narsoplimab, because these days it could be considered a basic human need.

Yup.  In fact, one of my (few) worries is that the longer we go without massive narso production funding support, the louder the screams will be when narso's benefits become widely known.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Well, let's make pretend we're compassionate people concerned for the welfare of others, as opposed to uncaring emotionless capitalists concerned only with their bank accounts.  I'd just as soon get more Narso out to the public sooner as opposed to later.  I think we'll make money either way, in my view the first scenario being preferable.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

alaskasalmonfisher wrote:

I'd just as soon get more Narso out to the public sooner as opposed to later.  I think we'll make money either way, in my view the first scenario being preferable.

Agree 100%

27 (edited by Alan Robert Ross 2021-01-26 09:43:41)

Re: OMER Comparators, Competitors, VALUATION & potential partners

ditto

SEE THIS
http://www.trustintelligence.com/viewto … 2417#p2417

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Edesa Biotech to Study Its Investigational Drug as Potential Rescue Therapy

Tue, January 26, 2021, 7:30 AM

TORONTO, ON / ACCESSWIRE / January 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that physicians involved in the company's ARDS study identified a number of COVID-19 patients who they believed could benefit from the experimental treatment, but were too ill to be considered for the main study. "This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.

Edesa's sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. The sub-study does not impact the design or results of Edesa's ongoing international Phase 2/3 study.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

Edesa's Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the United States and Colombia. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

Edesa's Vice President of Research and Development, Blair Gordon, PhD. said that data from the international sites will be aggregated and analyzed together. The sub-study, which is identical to the main study except for the patient enrollment criteria, will be analyzed separately. "The consistency of the study design across geographic regions and patient groups will allow us to efficiently evaluate the utility of the EB05 across a broad spectrum of hospitalized patients."

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).

About ARDS

Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company's two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

CV19 Endothelial Injury cause TMA is multiple organs, including kidney, heart, brain, and elsewhere... so this is not really a full competitor to narso.

Apparently their drug targets the most common organ effected, the lungs.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I note AUPH has gone from over $20 pre-market on Monday to under $16.50 at the moment.

If I wasn't exhausted and thinking about a nap, I'd be looking into it, perhaps because it will start earning revenue and bouncing back up.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Alan Robert Ross wrote:

I note AUPH has gone from over $20 pre-market on Monday to under $16.50 at the moment.

based on my quick read after you flagged it last week, it looks promising.
their Lupus drug seems on track to hit 1B+ in revenue
starting market cap (above 2bn) seems huge compared to OMER, given they just have this one new drug, but i guess that is pharma investing for you.

AUPH is on the stock twits board, but not reddit. Omer is on neither. I guess that will be the new shibboleth - "which social media platforms are talking up the stock?"

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Re: OMER Comparators, Competitors, VALUATION & potential partners

OMER is on Stocktwits, Steven.

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

33

Re: OMER Comparators, Competitors, VALUATION & potential partners

i see it. i guess i was comparing it to AUPH, which had 100's comments/day, while the omer thread was sparse

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Re: OMER Comparators, Competitors, VALUATION & potential partners

AUPH has a lot of empty posts rooting for the stock price without anything useful.

While there are too many 'empty' posts, people who post due diligence material is the highest density of any social media board. A number of scientists and MD, traders, and fundamental investors... and some cheerleading...

I went to the AUPH ST board to see if I could learn anything before posting about it on TI. It was useless childish "go team" crap.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

do you mean the AUPH thread has doctors on it, or OMER, or ST in general?

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Re: OMER Comparators, Competitors, VALUATION & potential partners

OMER

AUPH had nobody interesting when I looked at it.. Thursday I think.

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

37

Re: OMER Comparators, Competitors, VALUATION & potential partners

I looked at the AUPH ST board tonight and the people are blaming a Korean Group that are insiders in AUPH and wanted a change in management, for selling shares to hurt the stock or the CEO or???

They still own a lot.
Here's the filing:

Security    CA:AUP / Aurinia Pharmaceuticals Inc
Institution    ILJIN SNT Co., Ltd.
Latest Disclosed Ownership    8,995,439 shares
Ownership    7.10%
Related    AUPH / Aurinia Pharmaceuticals Inc
ILJIN SNT Co., Ltd. ownership in AUP / Aurinia Pharmaceuticals Inc
2021-01-27 - ILJIN SNT Co., Ltd. has filed an SC 13D/A form with the Securities and Exchange Commission (SEC) disclosing ownership of 8,995,439 shares of Aurinia Pharmaceuticals Inc (CA:AUP). This represents 7.1 percent ownership of the company. In their previous filing dated 2021-01-26, ILJIN SNT Co., Ltd. had reported owning 10,532,114 shares, indicating a decrease of -14.59 percent.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

earlier posts seemed to suggest the korean group had marketing rights outside USA and/or they were suing Auph for IP infringement or something. all i saw was the SEC 13 form filed that showed they owned more than 5%.

they people commenting didn't seem to understand what it meant.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I have looked a bit more at AUPH, which is big trouble when OMER gets approved for Lupus Nephritis, that is, if/when Omeros bothers.

With a potential 70,000 patients it probably will be worth it. The AUPH drug was tested WITH SOC and compared to SOC only. SOC is steroids, which are bad for you and have lots of side-effects on mood and behavior, in addition to physiologically, like cataracts and more serious problems.

Narsoplimab reduces proteinuria to a greater extent in IgAN patients, which is similar, and works to significantly improve the disorder EVEN WHEN STEROIDS ARE DISCONTINUED FIRST.

It looks like OMER won't be a problem until at least 2023 though, so AUPH may do well until then, and have some entrenched users at that time. Narso may sell some off-label before it is approved for Lupus, but it should not be a big problem for AUPH.

OTOH, this is their first product to market and that is not good. But they do have well over $300m cash and $100M/yr negative cash flow. I think this will cost $6k/pill.

A really bad market can make this a bargain, but it has a higher market cap than Omeros already, so you can't say it is exactly cheap.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

so can omer fix everything??? smile

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Everything with TMAs because of autoimmune diseases that are regulated by the lectin branch of the complement system.

Lupus Nephritis kidney damage was one of the indications in the OMER Phase 2 basket trial along with IgAN. Omeros decided to try to get approval on IgAN first.

As I recall, there weren't many patients.

Steroids are a really bad chronic treatment used for a VERY wide range of disorders. The Steroids only reduce the symptoms, and do not eliminate the auto-immune response, which could lead to the body attacking itself. For example, in the intestine and bowel is is Crohn's disease or IBS (irritable bowel syndrome). Lupus (the auto-immune condition) can attack organs other than the kidney (Nephritus).

Google wrote:

Lupus is a disease that occurs when your body's immune system attacks your own tissues and organs (autoimmune disease). Inflammation caused by lupus can affect many different body systems — including your joints, skin, kidneys, blood cells, brain, heart and lungs.

Narsoplimab, via inhibiting the lectin branch of complement (a part of the immune system), inhibits the immune system without making people unable to fight off infections. It turns off endothelial damaging effects caused by the immune system (which is auto-immune), so it is adjusting the immune system more than just treating the endothelial inflammation that causes damage and malfunction.

I have not studied the AUPH drug to understand its MOA yet... but if it still needs steroids to reduce inflammation, it is not stopping the inflammation by itself.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I own a little AUPH for what I hope will be a short term trade.  I agree its prospects long term are questionable for reasons of efficacy and safety compared to potential future competitors, like OMER.

FDA gave the drug (LUPKYNIS™ voclosporin) a black box with the approval. 

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

"Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death."

Ouch.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I did not know you did that, Ed.

I have a spread order in but the stock has run away with me.

Lupus sufferers need a general treatment that works.
Until then, treatments will almost have to come with nasty side effects because of immune supression.

The other auto-immune disorders are in a similar situation, like Crohn's which my best from from University has and has made him disabled for the last 50 years. Pain, digestive problems and one nasty side-effect after another from the drugs. 

And there are many of these immune problems that in the old days would probably just get you killed...or left out of the gene pool.

Good profit today in AUPH... showing once again (with twice as many shares as OMER) how cheap OMER really is!!!

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Thanks Alan. 

I'm appreciating the safety profile of Narsoplimab more and more every day.  We get the mechanics of the drug and understand why it is proving to be safe.  Taking  severe AEs out of the picture allows me to freely dream of all the applications for MASP2 inhibition.  I'm pleased that I can't possibly think of ALL of them.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I am wondering why ALPH is so weak.
I have seen post-acceptance weakness before and it is one of the things that put me off f doing too much biotech investing.

A look at the chart says to me that $16 is support and resistance.
https://api.wsj.net/api/kaavio/charts/big.chart?nosettings=1&symb=auph&uf=0&type=2&size=2&sid=13549817&style=320&freq=1&entitlementtoken=0c33378313484ba9b46b8e24ded87dd6&time=7&rand=343910154&compidx=aaaaa%3a0&ma=0&maval=9&lf=1&lf2=0&lf3=0&height=335&width=579&mocktick=1

I am looking for a spread with the low strike more under $16 than my existing small position (long $15 and short $18).

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Is anyone other than Steven and me interested in this one?

https://seekingalpha.com/article/440245 … nth-ago-14

Aurinia Pharmaceuticals Is A Better Value Today At $17 Than It Was A Month Ago At $14
Feb. 01, 2021 11:47 AM ETAurinia Pharmaceuticals Inc. (AUPH)GSK25 Comments20 Likes
Amit Ghate profile picture.
Amit Ghate
3.31K Followers
Summary
In the following, I review the recent FDA approval and label for LUPKYNIS and tease out some of the bullish implications.
I then consider more factors in the comparison to competitor drug Benlysta.
Finally, I build and justify a DCF model which yields a new price target of $64.25 for AUPH.
Over the past six months I have written two articles on Aurinia Pharmaceuticals (AUPH). In the first, I dove into the company's prospective treatment for lupus nephritis and then offered an estimate of valuation based on a multiple of peak sales. In the second, I explained why I thought the partnership with Otuska was positive -- not negative as the market generally believed. I also compared (with caveats) the performance of voclosporin (now LUPKYNIS) versus GlaxoSmithKline's (GSK) Benlysta, finding the former to be substantially more efficacious than the latter.

Subsequent to those articles voclosporin / LUPKYNIS has been approved by the FDA with very positive labeling. So today I'll review this development and its implications, update the comparison between the two new drugs and most importantly build a more rigorous initial valuation model for AUPH. Let's get started.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I follow what you're writing, but it seems to me that OMER is a better investment, and if AUPH has an inferior drug, then that is even more reason to focus on OMER.  That said, a quick trade with AUPH to capture a fast and rapid rise would be great, although I don't have a good track record of actually succeeding with that type of strategy.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I am not suggesting anyone buy it.
The pop was the gamble on the FDA approval.
I did not want to gamble on that.
In hindsight, the smart move was to take the money at $20 and run... but at $20 it looked like it would continue. The next logical opportunity was after the opening and the reaction to that. If the reaction to the opening was not to go higher it was a signal to watch closely looking to sell.

Now it is using $16 as both support and increasingly, as resistance. Some say stronger support is at $15.

The share price could make a big move BEFORE OMER gets narso approved for Lupus. Could also be up in anticipation before narso is approved for anything.

I am personally betting only that the stock stays above $16 at option expiration... and I am now looking to bet it stays above $15.

I want it to close today above $16, or I may reverse some trades... the market is strong but people are dumping. Could be the Robin Hood crowd of hot money kiddies, or shorts looking for something safe to short.

Difficult to know.

I asked for people to tell me if there is interest to guide me to how much I should post on the topic.

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

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Re: OMER Comparators, Competitors, VALUATION & potential partners

I am more and more interested in your spread tactics.  You are offsetting the cost of buying a long call at the lower price, by selling a covered call at the higher price.  In a way, you are betting on some degree of stability, within the 2 different strike prices.  Am I conceptually correct here?  Thanks.

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Re: OMER Comparators, Competitors, VALUATION & potential partners

Yes and no.
I hope to make some money on stability but I want the price to go up above the short strike price for maximum profit.

I sell the short side to recoup the time premium by buying the long call, which has time premium in it. In this way I can but ITM calls for (sometimes) less than their actual intrinsic value (at a discount).

So if AUPH goes to $20 and I am long $15s and short $18s, At the end, my broker buys the 15s and delivers to the buyer of the $18s. I end up with $3, even though the actual share price is at $20.

So far, I am correct in thinking  $16 is support for this stock. I would like it to end the series, 2 weeks from Friday, above $18.

It traded uncomfortably below $16 today and I do not want to see a close under that point.

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