Omeros Corporation Reports Third Quarter 2025 Financial Results
– Conference Call Today at 4:30 p.m. ET
-
Net loss for the third quarter of 2025 was
, or$30.9 million per share, compared to a net loss of$0.47 , or$32.2 million per share for the third quarter of 2024. For the nine months ended September 30, 2025, our net loss was$0.56 , or$89.8 million per share, compared to a net loss of$1.47 , or$125.5 million per share in the corresponding prior year period. Non-GAAP adjusted net loss for the three months and nine months ended September 30, 2025 was$2.15 , or$22.1 million per share, and$0.34 , or$89.1 million per share. Non-GAAP adjusted net loss excludes a non-cash charge for the change in the estimated fair value of embedded derivatives on our current term loan and convertible debt facilities.$1.46
-
At September 30, 2025, we had
of cash and short-term investments. As previously announced, on July 28, 2025, we issued and sold 5,365,853 shares of our common stock in a registered direct offering to entities managed by Polar Asset Management Partners (collectively, “Polar”) at a price of$36.1 million per share, representing a$4.10 14% premium to the closing price of our common stock on the date of the purchase agreement. We received in cash proceeds, net of offering expenses. Also, during the three months ended September 30, 2025, we sold 2.3 million shares of common stock pursuant to our at-the-market offering facility, generating net proceeds of$20.3 million .$9.0 million
-
Cash burn during the third quarter of 2025, exclusive of any financing proceeds, was
.$22.0 million
-
On October 10, 2025, we entered into an Asset Purchase and License Agreement (the “APLA”) with Novo Nordisk Health Care AG (“Novo Nordisk”). Closing of the transaction is subject to the satisfaction or waiver of certain customary closing conditions and is expected to occur in the fourth quarter of 2025. Pursuant to the APLA, Novo Nordisk will receive exclusive global rights in all indications to develop and commercialize zaltenibart (OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”), certain related monoclonal antibodies and antigen-binding fragments, and related pharmaceutical products. In exchange, we will receive up to an aggregate of
in upfront and milestone-based payments plus tiered royalties on global net sales. Specifically, we will receive an upfront cash payment of$2.1 billion to be paid upon closing and are eligible for:$240 million
-
An additional
in near-term milestone payments;$100.0 million
-
Up to
more in one-time milestone payments upon the first achievement of certain development and approval milestone events to be achieved by Novo Nordisk;$410.0 million
-
Up to
in one-time milestone payments upon the achievement by Novo Nordisk of certain sales-based and commercial milestone events; plus$1.3 billion
- Tiered royalties on annual global net sales of applicable products at rates ranging from a high single-digit to high-teens.
The upfront cash of
-
As previously disclosed, in March 2025, we resubmitted to the
U.S. Food and Drug Administration (“FDA”) our Biologics License Application (“BLA”) seeking regulatory approval for narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (“MASP-2”), for the treatment of TA-TMA. Pursuant to the Prescription Drug User Fee Act (“PDUFA”), the class 2 resubmission was assigned September 25, 2025 as the target action date. Following a comprehensive response to an FDA information request, the Agency extended the PDUFA date to December 26, 2025. We expect that FDA will meet this PDUFA date. All analyses requested by FDA as part of its review have been consistent with and have provided statistically significant support of narsoplimab’s benefit demonstrated in the analyses submitted as part of the BLA resubmission.
- In June 2025, we submitted our marketing authorization application (“MAA”) for narsoplimab in TA-TMA to the European Medicines Agency (“EMA”). EMA has completed validation of the MAA, confirming the acceptance of the submission and starting the formal review process by EMA’s Committee for Medicinal Products for Human Use. We expect the committee to render its opinion on the MAA in mid-2026.
“Our team delivered a series of accomplishments in the third quarter that I believe position Omeros for a potentially transformative period ahead,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “The crucial above-market financing completed in July, the development of the Novo Nordisk transaction expected to close before year-end, and FDA’s fast-approaching decision on approval for narsoplimab in TA-TMA – each of these strategic components was set in motion and consummated or greatly solidified during the quarter. Together, they could well provide the financial strength and operational flexibility to accelerate significantly the development across our first-in-class pipeline programs, including our long-acting MASP-2 inhibitor OMS1029, our PDE7 inhibitor OMS527 for the treatment of addictions and compulsions, our T-CAT program targeting multidrug-resistant pathogens, and our oncology therapeutic platform. Success in any one of these programs could deliver significant clinical benefit to our patients and substantial value to our shareholders. In the near term, we look forward to the closing of the Novo Nordisk transaction and, importantly, to FDA’s decision and the planned commercial launch of narsoplimab.”
Third Quarter and Recent Developments
- Recent developments regarding narsoplimab, our lead monoclonal antibody targeting MASP-2, include the following:
-
In anticipation of the potential approval of narsoplimab in TA-TMA, our
U.S. commercial organization is assembled and launch-ready, including the first wave of our sales force, all of whom have extensive experience in hematology and transplant centers.
- Engagements with decision makers at transplant centers, hospitals, and payers through pre-approval information exchanges have been consistently encouraging, with rapid recognition of narsoplimab’s favorable benefit-risk profile and dosing regimen in TA-TMA.
- Following anticipated approval for treatment of TA-TMA, narsoplimab will be marketed under the brand name YARTEMLEA®.
- We have established a national ICD-10 diagnostic code specific to TA-TMA and an associated CPT procedural code specifically for narsoplimab, together positioning narsoplimab, once approved, as the only reimbursable TA-TMA treatment. We also expect to receive a New Technology Add-On Payment (“NTAP”) under Medicare to support hospital reimbursement.
- Two peer-reviewed manuscripts detailing narsoplimab’s safety and survival benefits in high-risk TA-TMA patients were recently published in premier journals:
- “Survival in Adults with High Risk TA-TMA—A Comparative Analysis of Narsoplimab Versus Supportive Care,” published in Blood Advances, highlights survival benefits with narsoplimab in TA-TMA patients (both pivotal clinical trial and global expanded access program participants) versus a well-matched external control group receiving standard of care.
-
“Narsoplimab Results in Excellent Survival in Adults and Children with Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy (TA-TMA),” published in the American Journal of Hematology, reports survival outcomes in patients treated, under our expanded access program, with narsoplimab either as first-line therapy or as salvage treatment in those who failed prior regimens with other complement agents including C5 inhibitors, and/or defibrotide.
In both published studies, and consistent with previous narsoplimab clinical studies, no safety signals of concern were observed.
- Recent developments in other programs include the following:
-
We were previously awarded a three-year,
grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered phosphodiesterase 7 (“PDE7”) inhibitor for the treatment of cocaine use disorder. The grant is intended to support (i) preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration and (ii) an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adult cocaine users who receive concurrent intravenous cocaine. The preclinical studies, designed with NIDA toxicologists, were completed with no safety findings and provide drug-interaction safety data in support of the planned in-patient human study of OMS527 in cocaine users. FDA has requested that the Company provide additional preclinical information prior to initiating the clinical in-patient study in cocaine users, which we target for the second half of 2026.$6.24 million
- We have continued to advance IND-enabling work in our OncotoX biologics program focused first on acute myeloid leukemia (“AML”).
- OncotoX-AML shows broad application across AML regardless of genetic mutation including TP53, NPM1, KMT2A, and FLT3.
- Human tumor-bearing animal and in vitro human AML cell-line studies show superior efficacy of our OncotoX-AML to standard of care. Results to date from an ongoing safety study in non-human primates are encouraging.
-
With the assistance and guidance of our Oncology Clinical Steering Committee, composed of leaders in AML treatment and research at premier cancer centers across
the United States , we estimate that our OncotoX-AML therapeutic could enter the clinic in 18-24 months.
- Our Targeted Complement Activating Therapy (“T-CAT”) platform – a new class of pathogen-targeting recombinant antibodies designed to target and directly kill bacteria, fungi, viruses, and parasites – continues to amass animal data across multiple pathogen classes and species. Our initial focus is on multidrug-resistant organisms (“MDROs”), widely recognized as one of the most critical unmet needs in medicine.
Financial Results
Net loss for the third quarter of 2025 was
At September 30, 2025, we had
We have an at-the-market equity offering facility through which we may, from time to time, offer and sell shares of our common stock for aggregate gross proceeds of up to
Cash burn during the third quarter of 2025, exclusive of any financing proceeds, was
For the third quarter of 2025, we earned OMIDRIA royalties of
Total operating expenses for the third quarter of 2025 were
Interest expense during the third quarter was a credit of
During the third quarter of 2025, we earned
Net loss from discontinued operations, net of tax, was
Conference Call Details
Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.
For online access to the live webcast of the conference call, go to Omeros’ website at https://investor.omeros.com/upcoming-events.
To access the live conference call via phone, participants must register at the following URL https://edge.media-server.com/mmc/p/fozurj7b/ to receive a unique PIN. Once registered, you will have two options: (1) dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the “Call Me” option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.
A replay of the call will be made accessible online at https://investor.omeros.com/archived-events.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications, with a particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is under regulatory review by both the
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated review process and timing of regulatory action on our BLA for narsoplimab in
Non-GAAP Financial Measures
This press release includes financial measures that are not calculated in accordance with
OMEROS CORPORATION |
||||||||||||||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
(In thousands, except share and per share data) |
||||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
September 30, |
|
September 30, |
||||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
$ |
15,995 |
|
|
$ |
24,084 |
|
|
$ |
61,850 |
|
|
$ |
96,203 |
|
Selling, general and administrative |
|
|
10,397 |
|
|
|
11,323 |
|
|
|
31,865 |
|
|
|
37,395 |
|
Total costs and expenses |
|
|
26,392 |
|
|
|
35,407 |
|
|
|
93,715 |
|
|
|
133,598 |
|
Loss from operations |
|
|
(26,392 |
) |
|
|
(35,407 |
) |
|
|
(93,715 |
) |
|
|
(133,598 |
) |
Interest expense, net of remeasurement adjustments and other |
|
|
13,355 |
|
|
|
(4,052 |
) |
|
|
9,686 |
|
|
|
(21,498 |
) |
Interest and other income |
|
|
616 |
|
|
|
2,346 |
|
|
|
2,979 |
|
|
|
9,008 |
|
Loss on early extinguishment of 2026 Notes |
|
|
— |
|
|
|
— |
|
|
|
(2,968 |
) |
|
|
— |
|
Net loss on change in fair value of financial instruments |
|
|
(8,822 |
) |
|
|
— |
|
|
|
(680 |
) |
|
|
— |
|
Net loss from continuing operations |
|
|
(21,243 |
) |
|
|
(37,113 |
) |
|
|
(84,698 |
) |
|
|
(146,088 |
) |
Net income (loss) from discontinued operations, net of tax |
|
|
(9,674 |
) |
|
|
4,881 |
|
|
|
(5,103 |
) |
|
|
20,631 |
|
Net loss |
|
$ |
(30,917 |
) |
|
$ |
(32,232 |
) |
|
$ |
(89,801 |
) |
|
$ |
(125,457 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Basic net income (loss) per share: |
|
|
|
|
|
|
|
|
||||||||
Net loss from continuing operations |
|
$ |
(0.32 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.39 |
) |
|
$ |
(2.51 |
) |
Net income (loss) from discontinued operations |
|
|
(0.15 |
) |
|
|
0.07 |
|
|
|
(0.08 |
) |
|
|
0.36 |
|
Net loss |
|
$ |
(0.47 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.47 |
) |
|
$ |
(2.15 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares used to compute basic net income (loss) per share |
|
|
66,263,992 |
|
|
|
57,948,093 |
|
|
|
61,049,886 |
|
|
|
58,232,007 |
|
OMEROS CORPORATION |
||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
(In thousands) |
||||||||
|
|
September 30, |
|
December 31, |
||||
|
|
2025 |
|
2024 |
||||
Assets |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
2,395 |
|
|
$ |
3,400 |
|
Short-term investments |
|
|
33,690 |
|
|
|
86,732 |
|
OMIDRIA contract royalty asset, short-term |
|
|
25,052 |
|
|
|
29,083 |
|
Receivables |
|
|
6,908 |
|
|
|
7,739 |
|
Prepaid expense and other assets |
|
|
3,760 |
|
|
|
7,166 |
|
Total current assets |
|
|
71,805 |
|
|
|
134,120 |
|
OMIDRIA contract royalty asset |
|
|
99,031 |
|
|
|
124,266 |
|
Right of use assets |
|
|
11,807 |
|
|
|
14,961 |
|
Property and equipment, net |
|
|
2,009 |
|
|
|
2,678 |
|
Restricted investments |
|
|
1,054 |
|
|
|
1,054 |
|
Total assets |
|
$ |
185,706 |
|
|
$ |
277,079 |
|
|
|
|
|
|
||||
Liabilities and shareholders’ deficit |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
12,499 |
|
|
$ |
5,905 |
|
Accrued expenses |
|
|
25,745 |
|
|
|
26,005 |
|
OMIDRIA royalty obligation |
|
|
19,301 |
|
|
|
20,645 |
|
Convertible senior notes, net |
|
|
17,036 |
|
|
|
— |
|
Term debt |
|
|
— |
|
|
|
21,000 |
|
Lease liabilities |
|
|
6,175 |
|
|
|
5,971 |
|
Total current liabilities |
|
|
80,756 |
|
|
|
79,526 |
|
OMIDRIA royalty obligation, non-current |
|
|
152,529 |
|
|
|
195,612 |
|
Convertible senior notes, non-current, net |
|
|
72,075 |
|
|
|
97,178 |
|
Term debt, non-current, net |
|
|
87,480 |
|
|
|
69,405 |
|
Lease liabilities, non-current |
|
|
8,843 |
|
|
|
13,466 |
|
Other accrued liabilities, non-current |
|
|
4,501 |
|
|
|
4,501 |
|
Shareholders’ deficit: |
|
|
|
|
|
|
||
Common stock and additional paid-in capital |
|
|
779,668 |
|
|
|
727,736 |
|
Accumulated deficit |
|
|
(1,000,146 |
) |
|
|
(910,345 |
) |
Total shareholders’ deficit |
|
|
(220,478 |
) |
|
|
(182,609 |
) |
Total liabilities and shareholders’ deficit |
|
$ |
185,706 |
|
|
$ |
277,079 |
|
OMEROS CORPORATION |
||||||||||||||||
UNAUDITED SCHEDULE OF INTEREST EXPENSE, NET OF REMEASUREMENT ADJUSTMENTS AND OTHER |
||||||||||||||||
(In thousands) |
||||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
September 30, |
|
September 30, |
||||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||||
OMIDRIA royalty obligation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Pass through interest remitted to administrative agent |
|
$ |
4,759 |
|
|
$ |
5,585 |
|
|
$ |
15,045 |
|
|
$ |
15,231 |
|
Non-cash remeasurement adjustment |
|
|
(22,292 |
) |
|
|
(3,359 |
) |
|
|
(34,170 |
) |
|
|
(1,553 |
) |
Interest expense, net of remeasurement on OMIDRIA royalty obligation |
|
|
(17,533 |
) |
|
|
2,226 |
|
|
|
(19,125 |
) |
|
|
13,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
2026 Notes |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contractual interest expense |
|
|
248 |
|
|
|
1,284 |
|
|
|
2,323 |
|
|
|
6,488 |
|
Amortization of debt discount and issuance costs |
|
|
20 |
|
|
|
144 |
|
|
|
260 |
|
|
|
713 |
|
Interest expense on 2026 Notes |
|
|
268 |
|
|
|
1,428 |
|
|
|
2,583 |
|
|
|
7,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Term Loan |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contractual interest expense |
|
|
2,258 |
|
|
|
2,433 |
|
|
|
6,723 |
|
|
|
3,147 |
|
Amortization of debt premium and issuance costs |
|
|
(1,512 |
) |
|
|
(2,060 |
) |
|
|
(4,727 |
) |
|
|
(2,659 |
) |
Interest expense on Term Loan |
|
|
746 |
|
|
|
373 |
|
|
|
1,996 |
|
|
|
488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
2029 Notes |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contractual interest expense |
|
|
1,682 |
|
|
|
— |
|
|
|
2,541 |
|
|
|
— |
|
Amortization of debt discount and issuance costs |
|
|
1,458 |
|
|
|
— |
|
|
|
2,206 |
|
|
|
— |
|
Interest expense on 2029 Notes |
|
|
3,140 |
|
|
|
— |
|
|
|
4,747 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Finance leases and other |
|
|
24 |
|
|
|
25 |
|
|
|
113 |
|
|
|
131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total interest expense, net of remeasurement adjustments and other |
|
$ |
(13,355 |
) |
|
$ |
4,052 |
|
|
$ |
(9,686 |
) |
|
$ |
21,498 |
|
OMEROS CORPORATION |
||||||||||||||||
UNAUDITED GAAP TO NONGAAP RECONCILIATION |
||||||||||||||||
(In thousands) |
||||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
September 30, |
|
September 30, |
||||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||||
|
|
|
||||||||||||||
Reconciliation of GAAP to Non-GAAP adjusted net loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net Loss |
|
$ |
(30,917 |
) |
|
$ |
(32,232 |
) |
|
$ |
(89,801 |
) |
|
$ |
(125,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Remeasurement on fair value of financial instruments |
|
|
8,822 |
|
|
|
— |
|
|
|
680 |
|
|
|
— |
|
Adjusted net loss from continuing operations |
|
$ |
(22,095 |
) |
|
$ |
(32,232 |
) |
|
$ |
(89,121 |
) |
|
$ |
(125,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP adjusted basic and diluted net loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reported basic and diluted net loss per share, continuing operations: |
|
$ |
(0.32 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.39 |
) |
|
$ |
(2.51 |
) |
Remeasurement on fair value of financial instruments |
|
|
0.13 |
|
|
|
— |
|
|
|
0.01 |
|
|
|
— |
|
Adjusted basic and diluted net loss per share from continuing operations |
|
$ |
(0.19 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.38 |
) |
|
$ |
(2.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reported basic and diluted net loss per share: |
|
$ |
(0.47 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.47 |
) |
|
$ |
(2.15 |
) |
Remeasurement on fair value of financial instruments |
|
|
0.13 |
|
|
|
— |
|
|
|
0.01 |
|
|
|
— |
|
Adjusted basic and diluted net loss per share |
|
$ |
(0.34 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average shares used to compute basic net loss per share |
|
|
66,263,992 |
|
|
|
57,948,093 |
|
|
|
61,049,886 |
|
|
|
58,232,007 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20251113632270/en/
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com
Source: Omeros Corporation