On this page of StockholderLetter.com we present the latest annual shareholder letter from OMEROS CORP — ticker symbol OMER. Reading current and past OMER letters to shareholders can bring important insights into the investment thesis.

 •  5/30/2025 Letter Continued (Full PDF)
 •  5/17/2023 OMER Stockholder Letter
 •  4/29/2024 OMER Stockholder Letter
 •  More "Drugs & Pharmaceuticals" Category Stockholder Letters
 •  OMER Benford's Law Stock Score = 94

OMER Shareholder/Stockholder Letter Transcript:

OMEROS
CORPORATION
" / / 6 " - 
3&1035

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L ET SCI ENC E LE AD TH E WA Y   
May 30, 2025
Dear Fellow Shareholders:
2024 was a year of significant progress for Omeros Corporation, marked by important clinical and regulatory
advancements across our pipeline, moving us closer to delivering multiple first-in-class therapeutics to patients
in indications for which there is no approved treatment or that hold substantial unmet need. At the same time,
we recognize that conditions in our industry and the broader economy have become more challenging in 2025,
and that these conditions might remain unpredictable for the foreseeable future. Despite these challenges, we
remain focused on successfully bringing narsoplimab to market, advancing our highest-value programs, and
delivering value to our shareholders. Our accomplishments during 2024 demonstrate the quality of our
programs, the strength of our science, and our commitment to the betterment of patients.
In 2024, we finalized with input from FDA the protocol and statistical analysis plan to compare survival of
patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) treated with
narsoplimab, our lead MASP-2/lectin pathway inhibitor, to that of TA-TMA patients in an external control
registry who were not treated with narsoplimab. The analyses were conducted by an independent statistics
group and results, which were announced in late 2024 and early 2025, reinforced what we had previously
observed: narsoplimab significantly improves survival in patients with TA-TMA. In the primary statistical analysis
comparing overall survival in the 28 TA-TMA patients in our previously conducted pivotal trial for narsoplimab in
TA-TMA to the external control, narsoplimab met its primary endpoint, with narsoplimab-treated patients
demonstrating clinically meaningful and statistically significant superiority in overall survival     a hazard ratio of
0.32 (representing a three-fold improvement in overall survival; 95% confidence interval: 0.23 to 0.44) with pvalue less than 0.00001     compared to the TA-TMA registry patients. Analyses comparing overall survival of
narsoplimab-treated TA-TMA patients enrolled in our global expanded access program to that in the same
control registry of well-matched TA-TMA patients showed a similarly strong survival benefit with narsoplimab
treatment, as did prespecified primary-related and EAP-related sensitivity analyses. Collectively, the results
strongly support the robustness of narsoplimab   s effect on survival in at-risk TA-TMA patients. These results
formed the basis of our Biologics License Application (BLA) for narsoplimab in TA-TMA, which we submitted to
the U.S. Food and Drug Administration in the first quarter of this year. FDA accepted the BLA and assigned a
Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025. This marks an important
milestone for Omeros and for patients suffering from this life-threatening complication of stem cell
transplantation.
We also made significant progress in our MASP-3 inhibitor program targeting the alternative pathway of
complement. In 2024, we substantially completed two Phase 2 trials evaluating our lead MASP-3 inhibitor
zaltenibart (OMS906) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)   one in treatment-na  ve
patients and another in patients with suboptimal response to C5 inhibitors. Results to date from both studies
have shown strong efficacy and a favorable safety profile, positioning us to initiate Phase 3 development in the
first quarter of 2025. Zaltenibart, which we believe is a    pipeline in a drug    given its potential for broad
applicability across multiple therapeutic areas and indications, was also granted rare pediatric disease
designation by the FDA for the treatment of complement 3 glomerulopathy (C3G).
Beyond our complement-focused programs, we advanced work with OMS527, our orally administered
phosphodiesterase-7 inhibitor being developed for the broad treatment of addictive and compulsive disorders.
With funding from the National Institute on Drug Abuse (NIDA), we successfully completed pre-clinical OMS527cocaine-drug interaction studies, and work is now underway to initiate the planned Phase 1b clinical in-patient

trial evaluating OMS527 for cocaine use disorder, also fully funded by NIDA, with results expected in late 2025 or
early 2026.
Our T-CAT platform, novel pathogen-targeting recombinant antibodies designed for broad applicability against
diverse microbial species without promoting or enhancing the development of drug resistance, also made
significant progress. The platform   s current focus is the treatment of multidrug-resistant organisms, which
represent a growing global medical and economic threat.
Omeros    novel oncology platform remains a dynamic area of innovation, producing strong preclinical data across
multiple programs. These programs are designed to overcome key limitations of current cancer therapies. We
look forward to continuing the strong momentum of these programs while advancing opportunities for clinical
translation.
Overall, 2024 represents what appears to be a watershed year for Omeros, marked by significant progress
across all our platforms and programs. As we look forward to the upcoming FDA decision on the narsoplimab
BLA for the treatment of TA-TMA, all of us at Omeros remain committed to succeeding in our mission to develop
therapeutics that profoundly enhance the lives of the patients we serve.
We thank you for your continued support and confidence.
Sincerely,
Gregory A. Demopulos, M.D.
Chairman & Chief Executive Officer

'03.    ,



 5/30/2025 Letter Continued (Full PDF)