– Conference Call Today at 4:30 p.m. ET
–
Omeros Corporation (Nasdaq: OMER), a clinical-stage
biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for
large-market and orphan indications targeting immunologic disorders
including complement-mediated diseases, cancers, and addictive and
compulsive disorders, today announced recent highlights and
developments as well as financial results for the first quarter
ended March 31, 2023, which include:
- Net loss was $33.7 million in the first quarter of 2023, or
$0.54 per share, compared to a net loss in the first quarter of
2022 of $33.0 million, or $0.53 per share; our first quarter’s net
loss from continuing operations was $39.7 million compared to $39.5
million in the first quarter of 2022, and $0.63 per share for both
periods. Cash burn for the first quarter of 2023 was $23.6 million,
exclusive of a $200 million milestone payment received in the
quarter, a decrease from $26.0 million in the prior quarter.
- In February 2023 we received from Rayner Surgical, Inc.
(“Rayner”) the $200 million milestone payment due under the Asset
Purchase Agreement by which we sold our former ophthalmology
product OMIDRIA® to Rayner in late 2021. The payment became due
upon the achievement of the milestone event in December 2022 and
was recorded as a receivable in the fourth quarter of 2022.
- For the quarter ended March 31, 2023, we earned OMIDRIA
royalties of $9.2 million on Rayner’s U.S. net sales of $30.7
million. This compares to earned royalties of $13.8 million during
the first quarter of the prior year on U.S. net sales of $27.7
million. The above-referenced milestone event triggered a reduction
of our U.S. base royalty rate from 50 percent to 30 percent.
- At March 31, 2023, we had $371.4 million of cash, cash
equivalents and short-term investments available. In addition, we
had $10.0 million of accounts receivable.
- We intend to resubmit our Biologics License Application (“BLA”)
for narsoplimab in hematopoietic stem cell transplant-associated
thrombotic microangiopathy (“TA-TMA”) and, consistent with
direction from FDA’s Office of New Drugs, have submitted to FDA a
proposed plan for assessment of both response rate and survival
based on already existing clinical trial data and external data. A
meeting with the review division is scheduled for this month to
discuss the details of our proposed analyses and to confirm the
information required by FDA to support resubmission of the BLA for
narsoplimab’s approval.
- In April 2023, we announced positive results from a
pre-specified interim analysis of our ongoing Phase 1b clinical
trial of OMS906 in treatment-naïve adults with paroxysmal nocturnal
hemoglobinuria (“PNH”), and updated interim results are provided
later in this release.
- In April 2023, we were awarded a three-year $6.69 million grant
from the National Institute on Drug Abuse (“NIDA”), part of the
National Institutes of Health, to develop the lead orally
administered PDE7 inhibitor compound in our OMS527 program for the
treatment of cocaine use disorder (“CUD”).
“We are pleased with our progress during the first quarter as
our team continues to deliver on important milestones,” said
Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive
officer. “For our MASP-2 inhibitor narsoplimab, we are meeting with
FDA this month to discuss our proposed analysis plan and confirm
the specifics to be included in a BLA resubmission for TA-TMA, and
our Phase 3 IgA nephropathy trial remains on track for data
read-out next quarter. Our long-acting MASP-2 inhibitor is set to
begin enrolling its multiple-ascending-dose clinical trial this
summer in the U.S. Enrollment is marching ahead in our OMS906
clinical program. The results to date in treatment-naïve PNH
patients are impressive, making clear that our MASP-3 inhibitor
OMS906 blocks alternative pathway activation and should be
effective across AP-related diseases while potentially offering
significant safety, efficacy and compliance advantages over other
AP-targeting drugs. Now collaborating with and having received a
$6.69 million award from NIDA, we are moving forward to assess our
PDE7 inhibitor OMS527 in patients with cocaine use disorder. Our
immuno-oncology franchise is also rapidly progressing across both
our cellular and biologic platforms. Helping to fund the ongoing
achievements of these and our other programs is the non-dilutive
$200 million milestone payment received in February, forecast to
extend our cash runway into 2025. This year has started well for
Omeros, and we expect that momentum to continue.”
First Quarter and Recent Clinical Developments
- Recent developments regarding narsoplimab, our lead monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-2 (“MASP-2”) in advanced clinical programs for the
treatment of TA-TMA and immunoglobulin A (“IgA”) nephropathy,
include:
- We are preparing to meet with FDA’s Division of Nonmalignant
Hematology later this month to confirm the information required by
FDA to support resubmission of the BLA for narsoplimab’s approval
in TA-TMA. Consistent with direction from FDA’s Office of New
Drugs, provided as part of its denial of our appeal of the complete
response letter previously issued by FDA, we have proposed a plan
to assess already existing clinical trial data and external data on
both response rate and survival.
- In our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for
the treatment of IgA nephropathy, we remain on track to read out
9-month data on the proteinuria endpoint next quarter.
- Narsoplimab is the focus of two recent peer-reviewed
publications. One, in Thrombosis Journal, describes a 6-year-old
girl with TA-TMA following stem cell transplantation for severe
aplastic anemia who had failed treatment with defibrotide. Treated
with narsoplimab under compassionate use, her TMA resolved. A
recurrence of TMA triggered by parvovirus again was successfully
treated with narsoplimab. A second manuscript authored by
investigators at Weill Cornell Medicine is in press at Clinical and
Experimental Immunology. The manuscript reports a high correlation
between elevation of a biomarker of endothelial injury and TA-TMA.
Using plasma samples from patients in the narsoplimab pivotal
trial, the study also showed that, in those trial patients
classified as “responders,” narsoplimab restored biomarker levels
to those of stem-cell transplant patients without TMA while
biomarker levels in narsoplimab “non-responders” remained
high.
- The 49th annual meeting of the European Society for Blood and
Marrow Transplantation (EBMT), which recently concluded in Paris,
featured three presentations regarding narsoplimab in TA-TMA. The
first described the design of our ongoing multi-center Phase 2
study evaluating the efficacy and safety of narsoplimab in
high-risk pediatric patients with TA-TMA. The second was a case
report of a patient treated with narsoplimab under our
compassionate use program. The patient had worsening TA-TMA
following withdrawal of calcineurin inhibitors, which resolved
following narsoplimab treatment. The third was a report of five
cases of high-risk pediatric TA-TMA. Three of five failed treatment
with the C5 inhibitor eculizumab. Two of these three patients also
failed treatment with defibrotide and were then treated with
narsoplimab, provided under compassionate use. Following
narsoplimab treatment, TA-TMA resolved.
- At the annual meeting of the American Society of Pediatric
Hematology/Oncology, being held this week in Fort Worth, Texas,
clinical investigators will present the course of a 3-year-old girl
with relapsed high-risk neuroblastoma who developed refractory
TA-TMA following a second stem cell transplant. After failing
treatment with each of eculizumab and defibrotide, the patient’s
TA-TMA resolved following treatment with narsoplimab.
- A case report on narsoplimab treatment of a patient with
recurrent IgA nephropathy was featured at the recent annual meeting
of the Korean Society of Nephrology. Treatment with narsoplimab
stabilized both proteinuria and estimated glomerular filtration
rate (“eGFR”). Kidney biopsy results confirmed the beneficial
effects of narsoplimab in this patient. This was the first report
of complement inhibitor treatment of a patient with recurrent IgA
nephropathy.
- A manuscript authored by a group of international experts
detailing the role of the lectin pathway in the pathophysiology of
IgA nephropathy, including glomerular injury, thrombotic
microangiopathy, and tubulointerstitial fibrosis, was recently
accepted for publication in Kidney International.
- Recent developments regarding OMS1029, our long-acting,
next-generation MASP-2 inhibitor, include:
- In April 2023, we announced results from a pre-specified
interim analysis of our ongoing Phase 1b clinical trial of OMS906
in treatment-naïve adults with PNH. Updated data from this open
label trial continue to show statistically significant and
clinically meaningful improvements in all measured markers of
hemolysis, including hemoglobin (“Hgb”) and lactate dehydrogenase
(“LDH”). Despite all patients having received only the lowest of
doses planned for the trial, data compare very favorably to those
publicly available for marketed and in-development alternative
pathway inhibitors. Enrollment is ongoing. Updated data are
provided below (“n”, or the number of patients, at each time point
ranges from 3 to 9 depending on each patient’s respective date of
enrollment):
Hemoglobin
- Mean baseline Hgb is 6.78 g/dL (normal: 12.0–15.6 g/dL for
women, 13.5–17.2 g/dL for men)
- Mean absolute increase in Hgb is 3.4 g/dL at Day 29, 6.3 g/dL
at Day 85, and 9.7 g/dL at Day 113
- After only 1 dose (by Day 29), Hgb increased ≥ 2 g/dL in 67% of
patients
- After only 2 doses (by Day 57), Hgb increased ≥ 2g/dL in 100%
and by ≥ 4 g/dL in 80% of patients
- By Day 85, 67% of patients had Hgb ≥ 12 g/dL; by Day 113, 100%
of patients had Hgb ≥ 15.7 g/dL
- Mean reduction in absolute reticulocyte counts from baseline
were ≥ 70,000/µL (range 70,000 – 136,000/µL) at all time
points
- No patients have had a clinical breakthrough or thrombotic
event, and none have required a transfusion while receiving
OMS906
LDH
- Mean baseline LDH is 1931 U/L (~8-fold higher than the upper
limit of normal)
- Mean reduction in LDH is 83% at Day 15, 80% at Day 29, and 87%
at Day 113
- At Day 113, LDH for all patients is normal or < 1.5 times
normal
Both Hgb and LDH improvements are
statistically significant at all time points in the trial; OMS906
has been well tolerated and there have been no safety signals of
concern.
- Based on PK/PD data from a successful Phase 1
single-ascending-dose study of OMS906 in healthy subjects and the
interim data from our Phase 1b clinical trial in treatment-naïve
PNH patients, we are planning a dosing frequency of once quarterly,
either intravenously or subcutaneously.
- We are also enrolling a Phase 1b clinical trial evaluating
OMS906 in PNH patients who have had an unsatisfactory response to
the C5 inhibitor ravulizumab. This study has a “switch-over” design
and enrolls PNH patients receiving ravulizumab, adds OMS906 to
provide combination therapy with ravulizumab for 24 weeks, and then
provides OMS906 monotherapy in patients who demonstrate a
hemoglobin response with combination therapy. Patient treatment
with OMS906 is underway.
- A Phase 1b clinical program evaluating OMS906 in patients with
complement 3 glomerulopathy (“C3G”) is also ongoing.
- Additional updates on data from our three OMS906 trials in
progress are planned for the second half of this year.
- The Annual Meeting of the European Hematology Association to be
held this June in Frankfurt, Germany, will feature a presentation
on the study design of our two ongoing clinical trials of OMS906 in
patients with PNH, along with results from our
single-ascending-dose Phase 1 study evaluating both intravenous and
subcutaneous administration of OMS906 in healthy subjects.
- Recent developments regarding OMS527, our phosphodiesterase 7
(“PDE7”) inhibitor program focused on addiction and movement
disorders, include:
- In April 2023, we were awarded a grant from the National
Institute on Drug Abuse, part of the National Institutes of Health
to develop our lead orally administered PDE7 inhibitor compound for
the treatment of cocaine use disorder (“CUD”). The grant – $6.69
million over three years – is intended to support a preclinical
cocaine interaction study and a randomized, placebo-controlled,
inpatient clinical study evaluating the safety and effectiveness of
OMS527 in patients with CUD. A Phase 1 clinical trial of the study
drug in healthy subjects was successfully completed.
- OMS527 is also being evaluated by investigators at Emory
University as a potential treatment for levodopa-induced
dyskinesias (“LID”), which are crippling, involuntary movements
reportedly affecting 50 percent or more of levodopa-treated
patients with Parkinson’s disease. LID is caused by prolonged
treatment with levodopa, the most prescribed treatment for the over
10 million patients with Parkinson’s disease worldwide. Data on
OMS527 in LID will be publicly disclosed following the filing of
appropriate patent applications.
Financial Results
Net loss for the first quarter of 2023 was $33.7 million, or
$0.54 per share. This compares to a net loss in the first quarter
of 2022 of $33.0 million, or $0.53 per share. Net loss from
continuing operations for the first quarter of 2023 was $39.7
million compared to $39.5 million in the first quarter of 2022, and
$0.63 per share for both periods. Cash burn for the first quarter
of 2023 was $23.6 million, exclusive of the $200 million milestone
payment from Rayner, compared to $26.0 million in the fourth
quarter of 2022.
During the first quarter of 2023, we earned royalties of $9.2
million on $30.7 million of Rayner’s U.S. net sales of OMIDRIA.
This compares to earned royalties of $13.8 million during the first
quarter of the prior year on U.S. net sales of $27.7 million. These
royalties were recorded as a reduction of the OMIDRIA contract
royalty asset. Omeros received a $200 million milestone payment
from Rayner in the first quarter of 2023 in connection with the
Asset Purchase Agreement under which Rayner purchased our OMIDRIA
business. The achievement of the milestone event in late December
2022 triggered a reduction of our U.S. base royalty rate from 50
percent to 30 percent.
Total costs and expenses for the first quarter of 2023 were
$35.7 million compared to $35.0 million for the first quarter of
2022.
Interest expense during the first quarter of 2023 was $7.9
million compared to $4.9 million during the first quarter of 2022.
The increase was due to interest on our OMIDRIA contract royalty
obligation associated with the sale of a portion of our OMIDRIA
royalty receivables, which we entered into during the third quarter
of 2022.
During the first quarter of 2023, we earned $4.0 million in
interest and other income compared to $0.5 million in the prior
year quarter. The increase was due to higher average balances
available to invest and higher market interest rates in the current
year quarter.
Net income from discontinued operations, net of tax was $6.0
million, or $0.09 per share, in the first quarter of 2023 compared
to $6.5 million, or $0.10 per share, in the first quarter of
2022.
As of March 31, 2023, we had $371.4 million of cash and
short-term investments, all of which are held in our name,
available for operations and debt service. In addition, we had
$10.0 million in accounts receivable. Our cash provided by
operations during the first quarter of 2023 was $174.5 million and
included the $200.0 million collection of the Rayner milestone
payment.
Conference Call Details
To access the live conference call via phone, please dial (800)
715-9871 from the United States and Canada or (646) 307-1963
internationally and ask to be placed into the Omeros earnings call.
Please dial in approximately 10 minutes prior to the start of the
call. A telephone replay will be available for one week following
the call and may be accessed by dialing (800) 770-2030 from the
United States or Canada or (609) 800-9909 internationally. The
replay access code is 8266699.
For online access to the live or subsequently archived webcast
of the conference call, go to Omeros’ website at
https://investor.omeros.com/upcoming-events.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting immunologic disorders including complement-mediated
diseases, cancers, and addictive and compulsive disorders. Omeros’
lead MASP-2 inhibitor narsoplimab targets the lectin pathway of
complement and is the subject of a biologics license application
pending before FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TA-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.
Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a
Phase 1 clinical trial. OMS906, Omeros’ inhibitor of MASP-3, the
key activator of the alternative pathway of complement, is
advancing across multiple clinical programs for alternative
pathway-related diseases, including paroxysmal nocturnal
hemoglobinuria (PNH) and complement 3 (C3) glomerulopathy. For more
information about Omeros and its programs, visit
www.omeros.com.
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
prospects for obtaining FDA approval of narsoplimab in TA-TMA and
anticipated next steps in relation to the biologics license
application for narsoplimab, expectations regarding the initiation
or continuation of clinical trials evaluating Omeros’ drug
candidates and the anticipated availability of data therefrom, and
expectations regarding growth in royalty-generating sales of
OMIDRIA, are based on management’s beliefs and assumptions and on
information available to management only as of the date of this
press release. Omeros’ actual results could differ materially from
those anticipated in these forward-looking statements for many
reasons, including, without limitation, unanticipated or unexpected
outcomes of regulatory processes in relevant jurisdictions,
unproven preclinical and clinical development activities, financial
condition and results of operations, regulatory processes and
oversight, challenges associated with manufacture or supply of our
investigational or clinical products, changes in reimbursement and
payment policies by government and commercial payers or the
application of such policies, intellectual property claims,
competitive developments, litigation, and the risks, uncertainties
and other factors described under the heading “Risk Factors” in the
company’s Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 13, 2023. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and the company
assumes no obligation to update these forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
OMEROS CORPORATION
UNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(In thousands, except share
and per share data)
Three Months Ended March
31,
2023
2022
Costs and expenses:
Research and development
$
24,610
$
24,087
Selling, general and administrative
11,103
10,959
Total costs and expenses
35,713
35,046
Loss from continuing operations
(35,713
)
(35,046
)
Interest expense
(7,933
)
(4,941
)
Interest and other income
3,963
493
Net loss from continuing operations
(39,683
)
(39,494
)
Net income from discontinued operations,
net of tax
5,982
6,483
Net loss
$
(33,701
)
$
(33,011
)
Basic and diluted net income (loss) per
share
Net loss from continuing operations
$
(0.63
)
$
(0.63
)
Net income from discontinued
operations
0.09
0.10
Net loss
$
(0.54
)
$
(0.53
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,828,765
62,724,775
OMEROS CORPORATION
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEET
(In thousands)
March 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
3,829
$
11,009
Short-term investments
367,527
183,909
OMIDRIA contract royalty asset,
short-term
28,940
28,797
Receivables
10,033
213,221
Prepaid expense and other assets
6,708
6,300
Total current assets
417,037
443,236
OMIDRIA contract royalty asset
119,681
123,425
Right of use assets
21,025
21,762
Property and equipment, net
1,335
1,492
Restricted investments
1,054
1,054
Total assets
$
560,132
$
590,969
Liabilities and shareholders’
equity
Current liabilities:
Accounts payable
$
6,446
$
5,989
Accrued expenses
30,821
30,551
Current portion of unsecured convertible
senior notes, net
94,554
94,381
Current portion of OMIDRIA royalty
obligation
2,943
1,152
Current portion of lease liabilities
4,427
4,310
Total current liabilities
139,191
136,383
Unsecured convertible senior notes,
net
221,209
220,906
OMIDRIA royalty obligation
123,057
125,126
Lease liabilities, non-current
21,287
22,426
Other accrued liabilities, non-current
452
444
Shareholders’ equity:
Common stock and additional paid-in
capital
724,354
721,401
Accumulated deficit
(669,418
)
(635,717
)
Total shareholders’ equity
54,936
85,684
Total liabilities and shareholders’
equity
$
560,132
$
590,969
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509006165/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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