– Conference Call Today at 8:30 a.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 second quarter
ended June 30, 2023, which include:
- Net loss was $37.3 million in the quarter ended June 30, 2023,
or $0.59 per share, compared to a net loss in the prior year
quarter of $30.8 million, or $0.49 per share. For the six months
ended June 30, 2023 our net loss was $71.0 million, or $1.13 per
share compared to $63.9 million, or $1.02 per share in the prior
year period. Cash burn for the second quarter was $30.1
million.
- For the second quarter of 2023, we earned OMIDRIA royalties of
$10.7 million on Rayner Surgical Inc.’s (“Rayner”) U.S. net sales
of $35.7 million. This compares to earned royalties of $17.2
million during the second quarter of the prior year on U.S. net
sales of $34.5 million. The base royalty rate applicable to U.S.
net sales of OMIDRIA decreased from 50 percent to 30 percent in
December 2022 upon recognition of the $200.0 million milestone
payment. The royalty rate applicable to any sales of OMIDRIA
outside the U.S. remains unchanged at 15 percent.
- At June 30, 2023, we had $341.3 million of cash, cash
equivalents and short-term investments available for operations and
debt servicing along with $11.2 million of accounts
receivable.
- In May 2023 we had a Type B meeting with the review division at
FDA to discuss the planned resubmission of our Biologics License
Application (“BLA”) for narsoplimab in hematopoietic stem cell
transplant-associated thrombotic microangiopathy (“TA-TMA”). Based
on the agency’s feedback we expect to submit to FDA early next
month a detailed plan for analysis of survival data from
already-identified external sources.
- In June 2023, results from a pre-specified interim analysis of
our ongoing clinical trial of OMS906 in treatment-naïve adults with
paroxysmal nocturnal hemoglobinuria (“PNH”) were presented at the
2023 congress of the European Hematology Association. Statistically
significant and clinically meaningful improvements were observed in
all measured markers of hemolysis, including hemoglobin and lactate
dehydrogenase. The OMS906 data were identified as one of the top
five late-breaking submissions of the congress and were selected
for presentation at a special oral session. At the end of July, we
performed another analysis of the data in hand through the date of
assessment. We continue to be highly encouraged by the results and
plan to present the data from this most recent analysis at the
upcoming congress of the American Society of Hematology in
December.
- The Phase 2 “switch-over” trial evaluating OMS906 in patients
demonstrating an unsatisfactory response to treatment with the C5
inhibitor ravulizumab is also underway. Seven of the targeted 12
patients have been enrolled with additional patients currently in
screening.
“Our team continued building significant shareholder value
throughout the second quarter of 2023,” said Gregory A. Demopulos,
M.D., Omeros’ chairman and chief executive officer. “Working with
FDA, we continue to make progress toward a resubmission of our
narsoplimab BLA for TA-TMA and are targeting a mid-2024 FDA
decision regarding approval. As we prepare for a good outcome and
subsequent market launch establishing narsoplimab as the first drug
approved for life-threatening TA-TMA, we remain on track to read
out Phase 3 data later this quarter from our ARTEMIS-IGAN trial
aimed at bringing narsoplimab to the large market opportunity of
high-proteinuria IgA nephropathy. Our next-generation MASP-2
inhibitor, OMS1029, is in the clinic, looking well-set to be a
once-quarterly subcutaneously or intravenously administered
therapeutic, and is slated to begin a Phase 2 program next summer –
and behind it, progressing toward the clinic, is our orally
available small-molecule MASP-2 inhibitor. In the other half of our
complement franchise, our Phase 2 clinical asset, OMS906, continues
to deliver data consistent with a premier drug targeting the
premier enzyme in the alternative pathway, increasing confidence in
our objective to make OMS906 the first-line, standard-of-care for a
wide range of alternative pathway disorders. At NIDA’s request and
with its significant grant funding, we are advancing OMS527, our
oral PDE7 inhibitor, to a Phase 2 clinical study as a treatment for
cocaine use disorder and are considering assessing the drug in a
Phase 2 trial for Parkinson’s-related levodopa-induced dyskinesia,
a crippling unmet need affecting millions of patients. Our cellular
and molecular immuno-oncology platforms also continue to mature,
and we are working hard to add them to our pipeline of clinical
assets. With a cash runway forecasted to fund operations well into
2025, we are strongly positioned to drive our development programs
and monetize our assets. Our team’s mission is to bring
transformational therapeutics to patients who need them – and that
requires relentless execution against our development milestones
and objectives. I’m proud of the way the Omeros team has executed
in the first half of 2023, and I expect that we will continue that
positive momentum into the back half of the year.”
Second 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 IgA nephropathy, include:
- In May, we had a Type B meeting with FDA’s Division of
Nonmalignant Hematology to discuss our planned resubmission of the
BLA for narsoplimab in TA-TMA. At the meeting, we received guidance
from the Agency on our proposal to collect and analyze certain
external survival data and to include these analyses in the BLA
resubmission. Based on the Agency’s guidance, we expect to submit
to FDA a detailed plan for analysis of those survival data, which
are from already-identified external sources. The proposal will be
submitted as a Type B meeting request, with FDA’s response expected
within 60 days. After receiving FDA’s feedback on our detailed
plan, we intend to conduct the analyses and, together with
additional new supportive data, plan to resubmit the BLA. Assuming
the full duration of relevant FDA review periods, we are targeting
an approval decision by FDA in mid-2024. We expect next to provide
investors with an update following BLA resubmission.
- 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 later this quarter.
- In late May, a review article authored by an international
group of experts was published in Kidney International. The article
describes kidney biopsies of IgA nephropathy patients, which
consistently showed glomerular deposition of mannan-binding lectin
together with IgA1 in up to 50% of patients with IgA nephropathy.
Glomerular deposition of pattern-recognition molecules in the
lectin pathway is associated with more severe glomerular damage and
more severe proteinuria and hematuria. Research also suggests that
lectin pathway activation contributes to tubulointerstitial
fibrosis in IgA nephropathy and other proteinuric kidney
disease.
- Our research efforts in COVID-19 and acute respiratory distress
syndrome (“ARDS”) continues at the Omeros-Cambridge Center for
Complement and Inflammation Research (“OC3IR”). A manuscript
detailing the beneficial effects of MASP-2 inhibition on both
symptoms and survival in chemically induced ARDS was published at
the end of May in Frontiers in Immunology. Another manuscript has
been submitted for publication describing the pulmonary and central
nervous systems benefits of MASP-2 blockade on symptoms and
survival in well-established animal models of COVID-19 ARDS.
Discussions are ongoing with the U.S. Government regarding
development of narsoplimab for use in severe COVID-19 and other
forms of ARDS.
- Recent developments regarding OMS1029, our long-acting,
next-generation MASP-2 inhibitor, include:
- Dosing in a Phase 1 multiple-ascending-dose study of OMS1029 in
healthy subjects was initiated on schedule in July. In a
single-ascending dose Phase 1 clinical trial completed in early
2023, OMS1029 was well tolerated and no safety concerns were
identified. Preliminary pharmacokinetic and pharmacodynamic
(“PK/PD”) data from that study showed dose-proportional exposure
and sustained lectin pathway inhibition, consistent with
once-quarterly intravenous or subcutaneous dosing. A Phase 2
program is slated to begin next summer.
- Recent developments regarding OMS906, our lead monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-3 (“MASP-3”), the key activator of the alternative
pathway, include:
- Enrollment is ongoing in our Phase 2 clinical trial evaluating
OMS906 in PNH patients who have had an unsatisfactory response to
the C5 inhibitor ravulizumab. The 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. Enrollment is
targeted for 12 patients, 7 of whom have already been enrolled with
others in screening.
- Enrollment has been completed in the clinical trial treating
patients who are not receiving complement inhibitors at entry
(i.e., treatment-naïve). Data collection continues and an abstract
detailing the most recent data analysis from late July has been
submitted to the American Society of Hematology Annual Meeting to
be held in December 2023.
- Our clinical program evaluating OMS906 in patients with
complement 3 glomerulopathy (“C3G”) is also underway. We are
amending the dose in this trial based on data from our ongoing and
completed clinical trials of OMS906 and expect soon to begin
enrolling C3G patients.
- We recently engaged a group of expert hematologists for an
advisory panel that yielded key insights on the current standard of
care for the treatment of PNH, the unmet patient need and other
factors affecting the market for PNH therapeutics. The session
informed our clinical development plans and commercial strategy for
OMS906 and, more generally, for our alternative pathway inhibitor
program.
- Recent developments regarding OMS527, our phosphodiesterase 7
(“PDE7”) inhibitor program focused on addiction and movement
disorders, include:
- We continue to pursue development of our lead orally
administered PDE7 inhibitor compound for the treatment of cocaine
use disorder (“CUD”). This work was initiated at the request of,
and is being performed in collaboration with, the National
Institute on Drug Abuse (“NIDA”), part of the National Institutes
of Health. The development efforts are supported by grant funding
from NIDA. The three-year, $6.69 million grant 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. Previously, a
Phase 1 clinical trial of the study drug in healthy subjects was
successfully completed.
- Along with collaborators at Emory University we continue to
evaluate the potential of our PDE7 inhibitors to treat
levodopa-induced dyskinesias (“LID”). LID is caused by prolonged
treatment with levodopa, the most prescribed treatment for the over
10 million patients with Parkinson’s disease worldwide. LID is
reported to affect 50 percent or more of levodopa-treated patients
with Parkinson’s disease. We are evaluating the data and will file
patent applications as appropriate.
Financial Results
Net loss for the quarter ended June 30, 2023 was $37.3 million,
or $0.59 per share. This compares to a net loss in the prior year
quarter of $30.8 million, or $0.49 per share. Cash burn for the
quarter ended June 30, 2023 was $30.1 million, an amount
artificially inflated by $3.4 million corresponding to Rayner’s
late payment of royalties received in July but due in June
2023.
For the second quarter of 2023, we earned OMIDRIA royalties of
$10.7 million on Rayner’s U.S. net sales of $35.7 million. This
compares to earned royalties of $17.2 million during the second
quarter of the prior year on U.S. net sales of $34.5 million. The
recognition of the $200 million milestone payment from Rayner in
December 2022 triggered a reduction of our U.S. base royalty rate
from 50 percent to 30 percent. Royalties are recorded as a
reduction of the OMIDRIA contract royalty asset on our balance
sheet.
Total costs and expenses for the second quarter of 2023 were
$40.9 million compared to $37.4 million for the second quarter of
2022. The increase was primarily due to the advancement of our
OMS906 program and incremental clinical trial costs for
narsoplimab. This increase was partially offset by reductions in
selling, general and administrative expenses.
Interest expense during the second quarter of 2023 was $7.9
million compared to $4.9 million during the prior year quarter. 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 second quarter of 2023, we earned $4.5 million in
interest and other income compared to $0.7 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 $7.0
million, or $0.11 per share, in the second quarter of 2023 compared
to $10.8 million, or $0.17 per share, in the second quarter of
2022.
As of June 30, 2023, we had $341.3 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
$11.2 million in accounts receivable.
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 5:30 a.m. Pacific Time;
8:30 a.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 this link 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 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
the anticipated next steps in relation to the biologics license
application for narsoplimab, the timing of regulatory events, the
availability of clinical trial data, the prospects for obtaining
FDA approval of narsoplimab in any indication, expectations
regarding the initiation or continuation of clinical trials
evaluating Omeros’ drug candidates and the anticipated availability
of data therefrom, and expectations regarding the sufficiency of
the Company’s capital resources to fund operations, 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, the Company’s
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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Costs and expenses:
Research and development
$
29,639
$
23,516
$
54,249
$
47,603
Selling, general and administrative
11,260
13,922
22,363
24,881
Total costs and expenses
40,899
37,438
76,612
72,484
Loss from operations
(40,899
)
(37,438
)
(76,612
)
(72,484
)
Interest expense
(7,932
)
(4,927
)
(15,865
)
(9,868
)
Interest and other income
4,537
670
8,500
1,163
Net loss from continuing operations
(44,294
)
(41,695
)
(83,977
)
(81,189
)
Net income from discontinued
operations
7,000
10,846
12,982
17,329
Net loss
$
(37,294
)
$
(30,849
)
$
(70,995
)
$
(63,860
)
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.70
)
$
(0.66
)
$
(1.34
)
$
(1.30
)
Net income from discontinued
operations
0.11
0.17
0.21
0.28
Net loss
$
(0.59
)
$
(0.49
)
$
(1.13
)
$
(1.02
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,837,125
62,730,015
62,832,991
62,727,395
OMEROS CORPORATION
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEET
(In thousands)
June 30, 2023
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$
6,603
$
11,009
Short-term investments
334,680
183,909
OMIDRIA contract royalty asset,
short-term
29,084
28,797
Receivables
11,190
213,221
Prepaid expense and other assets
7,001
6,300
Total current assets
388,558
443,236
OMIDRIA contract royalty asset
115,802
123,425
Right of use assets
20,258
21,762
Property and equipment, net
1,749
1,492
Restricted investments
1,054
1,054
Total assets
$
527,421
$
590,969
Liabilities and shareholders’
equity
Current liabilities:
Accounts payable
$
9,552
$
5,989
Accrued expenses
29,793
30,551
Current portion of unsecured convertible
senior notes, net
94,730
94,381
Current portion of OMIDRIA royalty
obligation
4,777
1,152
Current portion of lease liabilities
4,686
4,310
Total current liabilities
143,538
136,383
Unsecured convertible senior notes,
net
221,516
220,906
OMIDRIA royalty obligation
120,939
125,126
Lease liabilities, non-current
20,422
22,426
Other accrued liabilities, non-current
496
444
Shareholders’ equity:
Common stock and additional paid-in
capital
727,222
721,401
Accumulated deficit
(706,712
)
(635,717
)
Total shareholders’ equity
20,510
85,684
Total liabilities and shareholders’
equity
$
527,421
$
590,969
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809879247/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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