1

Topic: OMEROS

CMS (US Medicare) awarded Omidria "Separate Payment" instead of bundling it as a "surgical supply" in the ASC setting.
CMS wrote:https://charts.stocktwits.com/production/original_260997662.png

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

2

Re: OMEROS

CMS Confirms Continued Separate Payment for Omeros’ FDA-Approved OMIDRIA ® in Ambulatory Surgery Centers Separate payment for OMIDRIA retroactively effective as of October 1, 2020 —
December 03, 2020 07:30 AM Eastern Standard Time
SEATTLE--( BUSINESS WIRE )--Omeros Corporation (Nasdaq: OMER) announced today that the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros’ cataract surgery drug OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system (OPPS) and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate payment under CMS’ policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for OMIDRIA is effective retroactively beginning October 1, 2020.

“Omeros appreciates CMS’ decision to continue paying separately for our ophthalmic drug OMIDRIA,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Having just come off its pass-through status, this is the first time that OMIDRIA qualifies under CMS’ payment policy for non-opioid pain-management surgical drugs in the ASC setting. In addition to reducing patient exposure to opioids, CMS’ decision continues to provide important access to OMIDRIA for Medicare beneficiaries and to allow ophthalmic surgeons to use their best medical judgment to treat those patients. This is a good outcome for surgical facilities, surgeons and their patients.”

OMIDRIA is the first and only FDA-approved product for use during cataract or lens replacement surgery that prevents pupil constriction during surgery and reduces postoperative ocular pain. In post-marketing studies, OMIDRIA has been shown to have a broad range of benefits, including the reduction of sight-threatening complications and mitigating the need for intra- and postoperative steroids. OMIDRIA is approved for use in both adults and children.

About OMIDRIA ®

Omeros’ OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, (4) enable performance of surgery and postoperative care without the use of steroids, and (5) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

Important Safety Information for OMIDRIA ®

Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a rolling biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors.

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

3

Re: OMEROS

AstraZeneca buying Alexion in $39B
Cash + stock deal
Dec. 12, 2020

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

4

Re: OMEROS

OMEROS TO PRESENT AT THE 39TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
SEATTLE--(BUSINESS WIRE)--Jan. 11, 2021-- Omeros Corporation (Nasdaq: OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week. This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company’s website at www.omeros.com under “Events.” The archived webcast will be available for 30 days.

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

5

Re: OMEROS

BIOLOGICS LICENSE APPLICATION FOR NARSOPLIMAB IN HSCT-TMA ACCEPTED FOR PRIORITY REVIEW BY U.S. FDA
-- FDA sets PDUFA date of July 17, 2021 --

SEATTLE--(BUSINESS WIRE)--Jan. 19, 2021-- Omeros Corporation (Nasdaq: OMER) announced today that the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.

FDA grants Priority Review to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions. Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designations and orphan drug designations from FDA for each of HSCT-TMA and IgA nephropathy.

"The filing of our BLA by FDA marks an important milestone on the path to commercialization of narsoplimab," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There is no FDA-approved product for the treatment of transplant-associated TMA, a frequently fatal complication of stem cell transplantation. We appreciate FDA’s collaborative approach throughout the development of our breakthrough therapy-designated product narsoplimab, and we are committed to continue working closely with the FDA review team to make the drug available to patients who need it."

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

6

Re: OMEROS

https://www.forbes.com/sites/stephenbro … asons-why/

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

7

Re: OMEROS

Treating sequelae will be a huge task, with many patients, even ones who did not have severe CV19, over a long time period.

https://charts.stocktwits.com/production/original_292728494.jpg

{h/t to Stellar Capital for tweets}

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

8

Re: OMEROS

OMEROS AND QUANTUM LEAP ANNOUNCE FIRST PATIENTS DOSED WITH NARSOPLIMAB IN THE I-SPY COVID-19 TRIAL
-- Adaptive Platform Trial is Evaluating Drugs and Investigational Products in the Treatment of Critically Ill COVID-19 Patients --

SEATTLE & SAN FRANCISCO--(BUSINESS WIRE)--Mar. 23, 2021-- Omeros Corporation (Nasdaq: OMER) and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in the I-SPY COVID-19 Trial began earlier this month. The I-SPY COVID-19 Trial is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to screen rapidly, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality and avoid or reduce the duration of mechanical ventilation for critically ill COVID-19 patients.

“We’re excited that narsoplimab is one of the agents that has entered the I-SPY COVID-19 Trial,” said Laura Esserman, MD, MBA, co-founder of Quantum Leap Healthcare Collaborative, Principal Investigator of the I-SPY trial program, and Professor of Surgery and Radiology at the University of California – San Francisco. “The mechanism of action, specifically targeting endothelial injury, along with its safety profile and initial data generated in critically ill COVID-19 patients make a compelling case for this agent. The pulmonary and critical care investigators leading the I-SPY COVID Trial uniformly endorsed narsoplimab and made it a high-priority candidate for the trial. Together, we will be able to generate data on the ability of the agent to reduce the time to recovery and lower mortality.”

Narsoplimab is Omeros’ lead antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. It is the only complement inhibitor invited to participate in the I-SPY COVID-19 Trial. Narsoplimab has been administered under compassionate use to treat severely ill COVID-19 patients requiring mechanical ventilation, with impressive outcomes.

“Omeros is pleased to be working with Quantum Leap Healthcare Collaborative in this important effort,” said Gregory Demopulos, MD, Omeros’ chairman and chief executive officer. “With the multiple variants of SARS-CoV-2 already spreading globally, it is clear that vaccines alone likely will not be sufficient. Drs. Esserman, Calfee, and Liu and their team have established an innovative, efficient and rapidly enrolling platform trial to help identify treatments that can be useful in the fight against COVID-19, and we look forward to learning the outcomes of I-SPY study patients treated with narsoplimab.”

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

About Narsoplimab

Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

About the I-SPY TRIALS

The I-SPY 2 TRIAL for stage II and III breast cancer is the longest running and most successful adaptive platform trial in oncology. Quantum Leap was able to use the existing I-SPY 2 TRIAL infrastructure methodology to develop the I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning). The I-SPY COVID Trial is designed to rapidly screen promising experimental treatments, and re-purpose existing agents to identify the most effective treatments for severely ill COVID-19 patients. The trial is a unique collaborative effort by a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic donors, and clinicians from multiple major U.S. research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.quantumleaphealth.org and www.ispytrials.org.

About Quantum Leap Healthcare Collaborative

Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to all I-SPY Trials. For more information, visit www.quantumleaphealth.org.

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

9

Re: OMEROS

OMEROS’ NARSOPLIMAB PIVOTAL TRIAL DATA TO BE SHARED AS AN ORAL PRESENTATION AT THE EUROPEAN HEMATOLOGY ASSOCIATION CONGRESS
SEATTLE--(BUSINESS WIRE)--May 13, 2021-- Omeros Corporation (Nasdaq: OMER) today announced that data on organ function improvement from Omeros’ pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be shared as an oral presentation at the 2021 European Hematology Association (EHA) Virtual Congress. The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, will be delivered by Miguel-Angel Perales, M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center.

Dr. Perales’ oral presentation will be available on demand through the EHA Virtual Congress platform to registered meeting attendees beginning Friday, June 11, 2021 at 9:00 am CEST / 3:00 am EDT. The presentation abstract (S241) can be accessed on EHA’s website.

About Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for HSCT-TMA.

About Narsoplimab

Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of HSCT-TMA, and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). Narsoplimab is also being evaluated for the treatment of COVID-19 as a part of the I-SPY-COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative. The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company’s PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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

10

Re: OMEROS

OMEROS ANNOUNCES EXTENSION OF FDA REVIEW PERIOD FOR NARSOPLIMAB IN HSCT-TMA
-- PDUFA Date is October 17, 2021--

SEATTLE--(BUSINESS WIRE)--May 20, 2021-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today reported that the U.S. Food and Drug Administration (FDA) will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021.

As part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request. FDA has classified the response as a major amendment, which requires additional time to review.

“We’re pleased with our ongoing interactions with FDA on the narsoplimab BLA,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Omeros views the information provided in response to FDA’s information request as further supporting the application, and we look forward to making narsoplimab available to HSCT-TMA patients and their physicians as soon as possible.”

The first drug submitted to FDA for approval in HSCT-TMA, narsoplimab has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy. The BLA for narsoplimab in HSCT-TMA was accepted for filing in January 2021 under FDA’s Priority Review program.

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

11

Re: OMEROS

OMEROS ANNOUNCES PRELIMINARY RESULTS FROM ADDITIONAL CRITICALLY ILL COVID-19 PATIENTS TREATED WITH NARSOPLIMAB
-- Study Patients Comprise Second Cohort from Bergamo, Italy --

SEATTLE--(BUSINESS WIRE)--May 28, 2021-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the second cohort of critically ill COVID-19 patients treated with narsoplimab in Bergamo, Italy. These patients were part of the “second surge” of COVID-19 in Italy. Narsoplimab is the company’s lead inhibitor of mannan-binding lectin-associated serine protease 2 (MASP-2), the effector enzyme of the lectin pathway of complement.

“The COVID-19 patients in this group were even sicker than those in the first cohort of patients treated with narsoplimab at our institution during the pandemic’s outbreak,” said Alessandro Rambaldi, MD, Professor, Department of Oncology and Hematology-Oncology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy. “All of the patients had significant ARDS with 90 percent of them intubated at the start of narsoplimab treatment, the majority had multiple comorbidities and risk factors for poor outcome, and all had failed other therapies. The results in these patients are outstanding and further support what we have learned about the pathophysiology of COVID-19, the central role of endothelial damage in the disease, and the mechanism of action of narsoplimab.”

The patients were treated under compassionate use at ASST Papa Giovanni XXIII Hospital between October 2020 and April 2021. Highlights of the study are as follows:

Baseline characteristics of the 10 study patients

Median age: 65 years (range 41 to 79 years)
90% were men
All had comorbidities/risk factors for poor outcome (i.e., diabetes, cardiovascular disease/hypertension, overweight/obese, dyslipidemia)
Acute respiratory distress syndrome (ARDS) severity (by Berlin criteria) at time of intubation or ICU admission: 80% severe, 20% moderate
All had failed other therapies (steroids)
Narsoplimab treatment:

90% were intubated at initiation of narsoplimab treatment
Narsoplimab was administered intravenously twice weekly; median doses administered: 6 (range 3 to 8 doses)
Results:

80% recovered, survived and were discharged
2 deaths
76-year-old man from complications of pre-existing cardiomyopathy; received 3 doses of narsoplimab
68-year-old man from multi-organ failure; narsoplimab dosing was initiated after 13 days of intubation
Omeros plans to publish detailed data from the study in a peer-reviewed scientific journal.

“We are grateful to Dr. Rambaldi and his colleagues for their continuing work with narsoplimab and their dedication to treating critically ill COVID-19 patients,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “A greater focus in the war against COVID-19 is now being placed globally on therapeutics, and we believe that narsoplimab can contribute meaningfully to that effort. Unlike other drugs for COVID-19, narsoplimab targets the inflammatory endothelial disease – a central driver across variants. Our discussions continue with government agencies and NGOs in the US and internationally, and we look forward to additional clinical trial data on narsoplimab in critically ill COVID-19 patients.”

Narsoplimab is being evaluated in the I-SPY COVID-19 Trial, an adaptive platform clinical trial enrolling critically ill COVID-19 patients. The trial is sponsored by Quantum Leap Healthcare Collaborative and is funded in part by the United States government through the Biomedical Advanced Research and Development Authority (BARDA). Narsoplimab is the only complement inhibitor in the I-SPY trial.

Narsoplimab holds Breakthrough Therapy and Orphan designations in both hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and IgA nephropathy. The Biologics License Application for narsoplimab in HSCT-TMA is under Priority Review by FDA. The drug also is in Phase 3 clinical trials for IgA nephropathy and atypical hemolytic uremic syndrome.

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

12

Re: OMEROS

OMEROS ANNOUNCES PRELIMINARY RESULTS FROM PHASE 1 CLINICAL TRIAL OF OMS906
-- Results show good safety and PK/PD profile consistent with low-dose, once-monthly subcutaneous dosing --

SEATTLE--(BUSINESS WIRE)--Jun. 9, 2021-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. The ongoing trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) administration of OMS906 to healthy adult volunteers. OMS906 has been well tolerated at all doses tested. Preliminary human PK and PD data are consistent with once-monthly SC dosing.

MASP-3, the key activator of the alternative pathway of complement, converts pro-complement factor D (pro-CFD) to mature CFD. Inhibition of MASP-3 by OMS906 in nonhuman primates reduces systemic levels of mature CFD to below the threshold of detection, correspondingly blocking the alternative pathway of complement. The OMS906 Phase 1 clinical trial design consists of both single- and multiple-ascending dose cohorts. Pharmacodynamic response to OMS906 in the Phase 1 trial is being assessed by quantitation of mature CFD in plasma. In the single-ascending dose stage, 48 subjects have been evaluated to date across a series of IV and SC doses. Findings include:

OMS906, administered up to 5 mg/kg, has been well tolerated at all IV and SC doses tested with no apparent safety signals
Single 3 mg/kg IV dose of OMS906 suppresses mature CFD below minimum detectable levels for 4 weeks
Single lowest SC dose of OMS906 suppresses mature CFD at or below minimum detectable levels for 4 weeks
Dose-dependent PK/PD profile across all cohorts is favorable and supports low-dose, once-monthly or less frequent subcutaneous dosing
The study is ongoing with additional single- and multiple-dose cohorts to determine the pharmacologic dose range and optimal frequency for subcutaneous administration.

“The data from the Phase 1 clinical trial to date confirm our expectations for the role and dosing of OMS906 in humans,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “The data validate, in humans, the function of MASP-3 – the key activator of the alternative pathway – as a regulator of CFD and support the potential of OMS906 as a safe and long-acting therapeutic for the treatment of alternative pathway-related diseases and disorders. Omeros has built a strong intellectual property position around MASP-3 inhibition, and we look forward to completing the current study and advancing to a Phase 2 clinical trial as quickly as possible.”

About Omeros’ MASP-3 Inhibitor Program

The complement system plays a key role in inflammation and becomes activated as a result of tissue damage or microbial infection. Omeros’ MASP-3 inhibitor program includes potent molecules selectively inhibiting mannan-binding lectin-associated serine protease-3 (MASP-3), the protein activator of the alternative pathway of complement (APC). APC inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Omeros is developing both antibody and small molecules to block MASP-3. Through its growing intellectual property position, Omeros exclusively controls inhibitors of the protein activator of the alternative pathway (MASP-3) and, with its OMS721 program, inhibitors of the effector enzyme of the lectin pathway (MASP-2), allowing the company to target with unprecedented precision diseases caused by dysregulation of one or both of these pathways.

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

13

Re: OMEROS

OMEROS TO PRESENT AT THE BOFA 2021 NAPA BIOPHARMA VIRTUAL CONFERENCE
SEATTLE--(BUSINESS WIRE)--Jun. 9, 2021-- Omeros Corporation (Nasdaq: OMER), today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the BofA 2021 Napa BioPharma Virtual Conference next week. The fireside chat with Bank of America analyst, Geoff Meacham, PhD, is scheduled for Tuesday, June 15, 2021 at 4:30 p.m. EDT.

The presentation will be webcast. The live and archived webcasts can be accessed at https://investor.omeros.com/upcoming-events. The archived webcast will be available for 30 days.

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

14

Re: OMEROS

OMEROS ANNOUNCES PUBLICATION DETAILING THE MECHANISM OF ACTION OF PDE7 IN NICOTINE ADDICTION
-- Inhibitors of PDE7 Enzymes Could Treat Nicotine Abuse --

SEATTLE--(BUSINESS WIRE)--Jun. 10, 2021-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced publication of the article “Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission” in the peer-reviewed Journal of Neuroscience.

The article describes for the first time the effect of selective inhibitors of phosphodiesterase 7 (PDE7), an enzyme that regulates the intracellular levels of the second messenger cyclic adenosine monophosphate, on nicotine consumption. Specifically, inhibitors of PDE7 reduced nicotine consumption and relapse in rodent models of nicotine abuse. Inhibition of PDE7 by Omeros’ proprietary small molecules such as OMS527, which was previously reported to have no safety concerns and a pharmacokinetic profile consistent with once-daily oral dosing in its successful Phase 1 trial, resulted in potentiation of intracellular signaling linked to dopamine D1 receptors, which can restore the dopaminergic transmission altered by nicotine. In the study it was also observed that PDE7 inhibition did not elicit conditioned place preference and did not induce intravenous self-administration, indicating lack of abuse liability of OMS527. The research was conducted in collaboration with the School of Pharmacy of the University of Camerino in Italy.

“In my 30 years of research in addiction, I have rarely seen such a clear and promising effect as that seen with PDE7 inhibitors,” said Roberto Ciccocioppo, Professor of Pharmacology and Head of the School of Advanced Studies at the University of Camerino. “I am also excited about the mechanism of action of these molecules. They act by restoring the dopaminergic transmission, which is altered by chronic nicotine use. Equally important, they have this effect without any signs of abuse potential. Considering the general role of dopamine transmission in substance use disorder, I expect that administration of PDE7 inhibitors would also reduce the motivation of other drugs of abuse, such as opioids, psychostimulants and alcohol.”

About Tobacco Use Disorders

The World Health Organization (WHO) estimates that there are 1.25 billion smokers worldwide, representing one third of the global population over the age of 15. As many as 5 million deaths occur each year as a result of tobacco use. In industrialized countries, approximately 90% of lung cancer, 80% of chronic respiratory disease, and about 20% of cardiovascular diseases are attributed to tobacco use. Recent developments such as forms of electronic nicotine delivery are contributing to a new surge of nicotine use, especially in young adults. Development of novel and more efficacious treatment for smoking cessation can have an important impact on public health. Omeros owns global rights to the use of PDE7 inhibitors for the treatment of addictive disorders.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company’s PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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

15

Re: OMEROS

OMEROS’ NARSOPLIMAB PIVOTAL TRIAL DATA SHARED IN ORAL PRESENTATION AT 2021 ANNUAL CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION
-- Data on Organ Function Improvement Presented by Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering --

SEATTLE--(BUSINESS WIRE)--Jun. 14, 2021-- Omeros Corporation (Nasdaq: OMER) today announced that data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 26th Congress of the European Hematology Association (EHA). The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, was delivered last Friday by Miguel-Angel Perales, M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. The organ function improvement data presented underscore the potential of narsoplimab as a significant advance in the treatment of often fatal HSCT-TMA.

The trial’s findings include:

The study population was high-risk, with 93 percent having multiple risk factors for poor outcomes, and highly reflective of “real-world” clinical practice
At baseline:
75% of patients had kidney dysfunction
57% had neurologic dysfunction
18% had pulmonary dysfunction
50% had multiple organ TMA involvement
86% had significant infection
68% had graft versus host disease (GVHD)
61% of the intent-to-treat (ITT) population (any patient receiving at least 1 dose of narsoplimab) and 74% of the per-protocol (PP) population (those patients receiving ≥ 4 weeks of dosing) responded to narsoplimab based on improvement in laboratory TMA markers (platelet count improvement and reduction in LDH levels) and clinical status (organ function or freedom from transfusion)
74% of eligible patients in the ITT population experienced improvement in organ function (67%, 50% and 100% in kidney, neurologic, or gastrointestinal function, respectively); 77% of eligible patients in the PP population experienced organ function improvement
48% of eligible patients in the ITT population and 55% in the PP population experienced freedom from transfusion
Narsoplimab was well tolerated in this very sick population
The most common adverse events were pyrexia, diarrhea, vomiting, nausea, neutropenia, fatigue, and hypokalemia, all common in HSCT
Six patients died during the core study period due to causes common in HSCT
There were no study discontinuations due to non-fatal adverse events
Detailed data and findings from the study are being submitted to a peer-reviewed scientific journal for publication.

Dr. Perales’ question-and-answer panel discussion for his presentation is scheduled for Tuesday, June 15, at 1:00-1:45 pm CEST/7:00-7:45 am EDT and will be available to registered attendees through the EHA Congress virtual platform.

In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, significant morbidity is common with chronic organ injury often persisting. There is no approved treatment for HSCT-TMA. A Biologics License Application for use of narsoplimab in the treatment of HSCT-TMA is under Priority Review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act action date of October 17, 2021.

About Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for HSCT-TMA.

About Narsoplimab

Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of HSCT-TMA, and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). Narsoplimab is also being evaluated for the treatment of COVID-19 as part of the I-SPY-COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative. The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company’s PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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

16

Re: OMEROS

OMEROS COVID-19 NARSOPLIMAB DATA
PART 1: DATA TO DATE
Alan Robert Ross and Peter Cowling
trustintelligence.com
July 2, 2021
 
TERMS
CUP - Compassionate Use Program 
Narsoplimab - a monoclonal antibody, MASP2 inhibitor
CV19 - Covid-19
ARDS - acute respiratory distress syndrome
QLHC - Quantum Leap Healthcare Collaborative
CPAP - Continuous Positive Airway Pressure apparatus

SUMMARY
- Omeros is running a CUP that makes Narsoplimab available to severely ill CV19 patients with ARDS.
- Only patients who are very ill and have not responded to conventional therapy are eligible for enrollment.
- Results are available from 3 sources, for a total of 17 CV19 patients.
- Narsoplimab is now being used in a Phase 2 CV19 trial sponsored by QLHC.

Part 1 combines the 3 datasets to get a better picture of how Narsoplimab has worked in a real-world setting.
Part 2 applies the Narsoplimab CUP dataset to the structure of QLHC’s independent Phase 2 “I-SPY” trial.

NARSOPLIMAB & CV19
Narsoplimab does not kill the CV-19 virus.  What it does is manage an overreaction by the body's immune system, in its attempt to fight it off.  When the CV-19 virus first arrives, patients’ immune system has no prior knowledge of how to fight it.  The body therefore deploys a general purpose immune response mounted by what is known as the "complement system". 

The complement system tries to fight the virus off long enough for other parts of the immune system to develop a tailored response, designed to kill CV19, specifically.  Unfortunately, in some patients, the virus caused the immune system to overreact.  The overreaction doesn't help... it makes the situation far worse.  The overreaction itself is what triggers patients to become severely ill; at risk of dying (and later suffering from LongCovid, if they are fortunate enough to survive).  ARDS is the most prominent risk, but every organ has been shown to be compromised by CV-19, and all of them lead back to the immune overreaction that narsoplimab can eliminate.

Many other companies have had high hopes that their drugs could manage overreaction of the initial immune response; with drugs that address the ‘cytokine storm’ or ‘IL-6’, for example.  There have also been attempts to address the coagulation issues & ease breathing problems; to eliminate the damage caused by the immune overreaction.  All of these approaches may or may not turn out to help reduce symptoms, but none of them hold the key to them.  Narsoplimab addresses the problem in a unique place in the immune system and both 

- turns down the body's over-active immune response
- addresses the coagulation problems at their source 

CUP BACKGROUND
The data shows that, before Narsoplimab treatment commences, all patients are having significant problems breathing. Many are anesthetized, intubated and ventilated - meaning they are in critical condition. Further, the patients have failed normal treatment, and have pre-existing conditions. Overall, all patients have a very high mortality risk. 

COHORT 1: During the winter of 2020, Papa Giovanni Hospital in Bergamo, Italy treated six patients.
- The day before the initial Narsoplimab treatment all patients were on CPAP
- All 6 (100%) recovered, were discharged and had no LongCovid symptoms at 6 month followup
- Only 47% recovered in a control group using similar patients assigned by the same lead investigators

COHORT 2: On May 28, 2021, Omeros reported the results of a second CUP cohort.
- 9 patients were intubated on the day prior the first treatment
- 1 patient was first treated on CPAP
- all patients had a range of comorbidities & 8 of the 10 patients survived and were discharged.

LILLY PATIENT: In spring of 2021, Kneirman et al. published a case study of a CV19 CUP treatment of a severely-ill, ventilated employee of Omeros-competitor, Eli Lilly.
- the patient had failed multiple treatments and was intubated for 7 days prior to 1st narsoplimab dose
- the patient recovered and went back to work.

https://scontent.fpac1-2.fna.fbcdn.net/v/t1.6435-9/210197767_1896708503837725_9028258188013128053_n.jpg?_nc_cat=104&ccb=1-3&_nc_sid=730e14&_nc_ohc=Iv3KtrR12mUAX_J_HnY&_nc_ht=scontent.fpac1-2.fna&oh=e360b336254bc408e0ac8e1aadb21aee&oe=60E2C11E

DATA
I have compiled the data that describes the milestones during the treatment of these patients and present it, patient by patient, so you can see it for yourselves. Source data came from publicly available charts, published by Rambaldi et al. [https://doi.org/10.1016/j.imbio.2020.152001], Omeros Annual Meeting Presentation [June 11, 2021], and Knierman et al. [J. Allergy & Infectious Disease (2021: 2(1):24-28].

SURVIVAL RATE: Fifteen of the 17 patients (88.2%) fully recovered. No signs of LongCovid have been reported to date. Regrettably, two members of the most severely ill group, Cohort2, died during treatment.

Patient 8 (in the Table) was 76 years old, and died from complications of pre-existing cardiomyopathy.  The patient died nine days after treatment started, and received only three of the planned eight doses of Narsoplimab. 
Patient 11 was 68 years old.  He was intubated for 13 days before Narsoplimab was first administered.  He died 27 days after treatment started, of multiple organ failure. Note that, generally, death rate in CV19 is highly correlated with being intubated - particularly intubation duration.

CRUCIAL ENDPOINTS
Two important CUP milestones were 1) how fast patients improve and 2) how long before they were discharged from hospital.

IMPROVEMENT: ‘improvement’ here is defined as going from a more extreme form of breathing assistance to a less extreme type of assistance. For example, a patient was considered to have improved if they had their breathing tube removed, were brought out of anesthesia, and were put on a CPAP device. Someone who changed from assisted breathing to breathing on their own would be a clear improvement. Applying this qualitative approach, we find:
- 15 patients improved and were discharged.
- The median number of Narsoplimab treatments before first improvement was three.
- The median number of days it took for improvement was eight.

DISCHARGE 
‘Discharge’ is defined by the patient leaving the hospital. In effect, this means that the patient has recovered from the effects of CV-19 enough to no longer need hospital-level medical care.

- 15 patients were discharged between 15 and 91 days after treatment started.
- The median number of days to discharge was 33.
- The median number of Narsoplimab doses before discharge was seven.
- Only seven patients had all eight doses to recover.
- The median time until the last dose of narsoplimab was 19 days. The patients’ subsequent recovery implies that, by this time, Narsoplimab had done its job.

CLINICAL SUMMARY
Of the patients who survived:
- half of them started improving after only three treatments, a bit over a week after their first dose of Narsoplimab.
- 11 of 15 only needed two weeks or less of treatments before they improved.
- 11 of 15 left the hospital in 34 days or less, and seven of those left in four weeks or less.

IMPLICATIONS FOR NARSOPLIMAB PROGRESS IN THE I-SPY TRIAL
Narsoplimab is part of the ongoing I-SPY trial that seeks to finds therapeutic agents that can save the lives of people with severe cases of CV19, at risk of dying. Narsoplimab started in the trial in early March 2021, so it has been treating a succession of patients for about 17 weeks. Treatment only lasts a maximum of 4 weeks and QLHC only allows a maximum of 125 patients for each drug tested.

The CUP data presented and discussed in this article indicates that people treated with Narsoplimab
1. usually start to improve in their second week of treatment and
2. are likely to be discharged within 5 or 6 weeks

This suggests to me that all or almost all of I-SPY trial’s Narsoplimab patients have already improved,  recovered and gone home. Unless there is a surprise press release very soon, the second part of this article, next week, will tackle this question in more depth.

Note: Hat Tip to WT for his valuable help in the various stages of this article.

The foregoing is not investment advice. I own shares in Omeros and no one has compensated me for writing this article. © 2021 by Alan Robert Ross

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

17

Re: OMEROS

OMEROS COVID-19 NARSOPLIMAB DATA
PART 2: QUALIFYING CUP DATA APPLIED TO I-SPY PHASE 2 TRIAL
Alan Robert Ross
trustintelligence.com
July 6, 2021

TERMS
CUP - Compassionate Use Program 
Narsoplimab - a monoclonal antibody, Omeros’ MASP2 inhibitor
CV19 - Covid-19
ARDS - Acute Respiratory Distress Syndrome
CPAP - Continuous Positive Airway Pressure apparatus
SOC - Standard Of Care, which in the I-SPY trial is what the control group gets
AE - Adverse event

SUMMARY
Part 2 is about trying to use the already-collected Narsoplimab CV19 CUP data to predict how similarly ill CV19 patients would fare in the I-SPY Narsoplimab Phase 2 trial.

PART 1 RECAP
Biweekly treatment with Omeros’ Narsoplimab in the CUP led to:
- clinically significant improvement within two weeks
- discharge from the hospital of all 10 people who started out on CPAP breathing support
- 88% (15 of 17 patients) survival with a median of 33 days to discharge from hospital
But the patient population in the CUP was more severely ill than the average patient in the I-SPY trial.

PART 2 PREVIEW
Using the patient population, design, constraints & endpoints of the I-SPY trial, to
- construct a hypothetical I-SPY trial timeline for the Narsoplimab arm, based on CUP data recovery timeline for CUP patients that would be qualified to be enrolled in the I-SPY trial.
- estimate how well the Narsoplimab CV19 CUP patients eligible to enroll in I-SPY would have done in the I-SPY trial based upon their CUP data.

I-SPY TRIAL CHARACTERISTICS
The I-SPY trial is a controlled multi-treatment Phase 2 CV19 trial that has an “Adaptive Design”. This means that aspects of what is done can change as results are obtained. For example, the therapeutic treatments used as Standard of Care and/or the number of drugs being tested, may change. The official I-SPY trial listing can be found at : https://clinicaltrials.gov/ct2/show/rec … iew=record

The adaptive change that appears most relevant for Omeros (OMER) is that the rate of patient accrual will change based upon treatment efficacy. Drugs that help patients more/faster will be assigned more patients than the treatment arms with weaker less success.

Patient Population: At first glance, all of the 17 Narsoplimab CUP patients look eligible for the I-SPY trial, because I-SPY accepts male and female volunteers who test positive for CV19, if they are over 18 years of age, and rate 5 or higher on the WHO Ordinal Scale. (see Appendix of https://www.who.int/blueprint/priority- … 22020.pdf)

But 5 of these CUP patients would have been rejected because they have characteristics that are specifically excluded in the I-SPY trial protocol. Four of the 5 CUP patients would have been rejected for having been intubated for more than 120 hours before entering the trial. The fifth patient would have been rejected because s/he appeared to have more than a 50% estimated mortality rate  over the next 6 months.

https://scontent.fpac1-1.fna.fbcdn.net/v/t1.6435-9/214487030_1902364823272093_80433544066102154_n.jpg?_nc_cat=111&ccb=1-3&_nc_sid=730e14&_nc_ohc=OLpzL5eXV6QAX-qc4XY&_nc_ht=scontent.fpac1-1.fna&oh=81d7147bb65a10eeb8719ee4cbdca808&oe=60E93AC3
Table 1: It is obvious that the patients in the CUP, who would qualify for the I-SPY trial would have started to recover quickly and half of them were discharged in the time I-SPY’s endpoints allow for improvement. Only patient 6 had a long struggle, but it did end in discharge and no LongCovid symptoms when examined 6 months later.

Patient Assignment To Treatment Arms: When I-SPY enrolls patients, it randomly assigns each into a maximum of 1 Control and 8 Experimental Treatment groups. I-SPY increases the number of patients assigned to drugs that perform well and reduces the ongoing flow to those who do poorly, as part of their adaptive design. I-Spy has not publicly explained how many more or less patients are assigned, probably because it depends on the flow of total enrollment. I-SPY has increased the number of trial centers to increase the number of patients enrolling, so I’ve presumed that the number of patients added weekly for a drug with more than average efficacy would increase by 1 patient as long as relative efficacy was higher than average.

Patient Limits & Accrual: I-SPY set a minimum patient goal for each Treatment arm of 50 patients. When that minimum is reached it appears that the data for that treatment arm is subject to a more thorough interim analysis. Continued assignment of patients to groups may be ended at that point, or after, for futility or for efficacy. Testing can continue, but I-SPY sets a maximum of 125 patients per treatment arm.

https://scontent.fpac1-1.fna.fbcdn.net/v/t1.6435-9/213382317_1902365256605383_5726139065492985661_n.jpg?_nc_cat=108&ccb=1-3&_nc_sid=730e14&_nc_ohc=OTDD-3k36oYAX-Vkyu2&_nc_ht=scontent.fpac1-1.fna&oh=a9e7914c98d80665457805ae85078397&oe=60E858F4
Table 2: Note that the Endpoints are “UP TO”a maximum  number of days. The maximum are not required. For example, If a patient is discharged in 30 days, to find out how many days the patient used a ventilator does not require 60 days. The 125 patients allowed by I-SPY rules would have already completed all the 28 day endpoints even at the maximum duration. All patients are scheduled to complete the maximum 60 day endpoints this month, but almost all of them are likely to have already been discharged and do not need the maximum of 60 days. In fact the maximum time for the Adverse Event and Ventilation endpoints do not seem crucial for patients likely to be discharged with a median of 28 days (see Table 1 for these data).
If all the patients needed the full 60 days to reach endpoints, data collection would be completed this month. This is quite unlikely, although the can be outliers like CUP patient 6.

Patient Treatment: The only treatment protocol we need to be concerned with is the one for the treatment arm using narsoplimab to treat patients. Treatment in I-SPY (twice a week) is the same as it was in the CUP.

Primary Endpoint: Patients have up to 28 days to hit the primary endpoint, which is: "Time to achieve durable change in Covid-10 to ordinal level 4 or less for at least 48 hours." WHO level 4 is less breathing assistance than "high flow oxygen". This would be a 1 stage improvement for people starting out on CPAP or High Flow, but a 2 Stage improvement for more severely ill patient who were intubated. Logic alone tells me improvement should be defined by a 1 stage change in the right direction. I think that could be what it is, but was not explained well in the trial listing.  The data on this endpoint is in Table 3, below.

Secondary Endpoints: There are 4 secondary endpoints in the I-SPY trial.
A) “% of COVID-19 level 5 who never progress to COVID-19 level 6/7 [...Up to 60 days]”  
B) “Ventilator-free Days  [...Up to 60 days]”  
C) “Total grade 3 or higher AEs” and “number of patients with grade 3 or higher AEs….
D) “Mortality at 28 days after study enrollment [...Up to 28 days ]
For some of the drugs being tested these endpoints may be a challenge, but for the Narsoplimab-treated CUP patients they mostly seemed to be easy to meet. All but 1 patient improved in 29 days or less. There were few days when the patients were being ventilated, no adverse events reported and no deaths occurred during the the trial, with all patients being discharged. 

https://scontent.fpac1-1.fna.fbcdn.net/v/t1.6435-9/213375655_1902366056605303_8164858280289986606_n.jpg?_nc_cat=110&ccb=1-3&_nc_sid=730e14&_nc_ohc=bb6BGDjvcPYAX9S_kBZ&tn=dghgPQE1dq6alIcu&_nc_ht=scontent.fpac1-1.fna&oh=105bb3444cbb285d0db807773470f5af&oe=60E96219


SUMMARY AND CONCLUSIONS
The 12 Narsoplimab CV19 CUP patients who would have been eligible for inclusion in the I-SPY trial all survived and were discharged from the hospital during the CUP and would likely have the same happy fate if enrolled in I-SPY. 
To the extent the ISPY enrollment model is accurate, the recovery data for the 12 CUP patients should be reproduced by the patients treated with Narsoplimab in the I-SPY trial. All I-SPY Narsoplimab arm data should be completed by the end of this month (July 2021), or already be complete, because the longest lasting Secondary endpoints may be complete in much less than 60 days.

All available evidence indicates Narsoplimab should be a clear CV19 treatment success in the I-SPY trial, saving the lives of those treated.

We await those results.

Note: Hat Tip to WT and PC for valuable help in the various stages of this article.
The foregoing is not investment advice. I own shares in Omeros and no one has compensated me for writing this article. © 2021 by Alan Robert Ross

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