– Conference Call Today at 1:30 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 third quarter
ended September 30, 2023, which include:
- Net loss was $37.8 million for the quarter ended September 30,
2023, or $0.60 per share, compared to a net loss in the prior year
quarter of $17.5 million, or $0.28 per share. The difference in the
current year quarter net loss was primarily attributable to an
incremental $18.9 million gain in discontinued operations in the
prior year quarter due to the remeasurement of the OMIDRIA contract
royalty asset. Net loss from continuing operations for the current
quarter was $51.7 million compared to a net loss of $54.8 million
in the prior year quarter. Cash burn for the quarter was $31.0
million.
- For the nine months ended September 30, 2023, our net loss was
$108.8 million, or $1.73 per share, compared to a net loss of $81.3
million, or $1.30 per share, in the prior year period. The primary
difference between the periods was the incremental gain from the
remeasurement of the contract royalty asset in the prior year. Net
loss from continuing operations for the nine months ended September
30, 2023 was $135.6 million compared to a net loss of $136.0
million in the prior year.
- For the third quarter of 2023, we earned OMIDRIA royalties of
$10.0 million on Rayner Surgical Inc.’s U.S. net sales of $33.3
million. This compared to earned OMIDRIA royalties of $16.5 million
during the third quarter of the prior year on U.S. net sales of
$33.0 million. The difference in earned royalties reflects the
decrease from 50 percent to 30 percent in the base royalty rate
applicable to U.S. net sales of OMIDRIA, which occurred in December
2022 upon achievement of the $200.0 million milestone payment
event.
- At September 30, 2023, we had $310.3 million of cash, cash
equivalents and short-term investments available for operations and
debt servicing. We expect to pay from our existing cash and
investments on hand the $95 million principal balance due at
maturity of our unsecured convertible senior notes on November 15,
2023.
- As part of our planned resubmission of our Biologics License
Application (“BLA”) for narsoplimab in hematopoietic stem cell
transplant-associated thrombotic microangiopathy (“TA-TMA”), we
have submitted to FDA a formal statistical analysis plan to compare
survival data from an already-identified external source. We
continue to target an FDA approval decision on our resubmitted BLA
in mid-2024.
- We have discontinued our Phase 3 ARTEMIS-IGAN clinical trial
evaluating narsoplimab for the treatment of immunoglobulin A
(“IgA”) nephropathy based on the results of a pre-specified interim
analysis, as announced in October 2023. Topline results showed that
narsoplimab did not reach statistically significant improvement
over placebo on the primary efficacy endpoint of reduction in
proteinuria. In-depth analysis of the ARTEMIS-IGAN data are
ongoing.
- An abstract with new and updated data from our Phase 2 clinical
trial evaluating OMS906 in patients with paroxysmal nocturnal
hemoglobinuria (“PNH”) who have not previously been treated with a
complement inhibitor has been selected for podium presentation at
the annual meeting of the American Society of Hematology (“ASH”),
upcoming in December. The presentation describes the clinically
meaningful and statistically significant effects of OMS906 across
all measured markers of hemolysis, including hemoglobin, lactate
dehydrogenase (“LDH”), and red blood cell clone size in PNH
patients.
- The Phase 2 “switch-over” trial evaluating OMS906 in PNH
patients who have demonstrated an unsatisfactory response to
treatment with the C5 inhibitor ravulizumab has completed
enrollment. Reporting of data is expected later this year or early
2024.
- Andreas Grauer, M.D. joined Omeros as chief medical officer. In
this role, Dr. Grauer is responsible for guiding all clinical
activities globally for the company, including clinical development
and operations, medical affairs, safety, and biometrics. A highly
tenured physician, scientist and pharmaceutical leader, Dr. Grauer
brings to Omeros over 20 years of industry experience across a
broad range of therapeutic areas.
“Having discontinued our Phase 3 ARTEMIS-IGAN trial, we are
closely examining the data to learn what happened and why so that
we can apply the findings to the design and conduct of future renal
clinical studies across our complement franchise,” said Gregory A.
Demopulos, M.D., Omeros’ chairman and chief executive officer. “Our
primary focus is achieving regulatory approval and
commercialization for our MASP-2 inhibitor narsoplimab to treat
TA-TMA patients and driving our MASP-3 inhibitor OMS906, believed
to be the premier alternative pathway target and drug, into
multiple Phase 3 programs and completing clinical development as
quickly as possible. The upcoming presentations at ASH should help
to focus others on the value of these programs – a TA-TMA approval
will validate both narsoplimab and our other MASP-2 programs for
which there are no predicates given Omeros’ broad patent position,
while the multiple indications already validated by other
alternative pathway inhibitors deliver a roadmap and are accretive
to OMS906 and our MASP-3 platform. We expect that Omeros has the
financial runway to capitalize on value-driving milestones for
these programs, and we intend to extend that runway further through
cost-containment measures and other means. Having secured
substantial funding from NIDA for OMS527 and with the potential to
lever a relatively small investment into a large value across our
immuno-oncology platforms, our pipeline of clinical and
earlier-stage assets remains robust with multiple opportunities to
grow shareholder value.”
Third Quarter and Recent Clinical Developments
- Recent developments regarding narsoplimab, our lead monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-2 (“MASP-2”), include the following:
- We continue to work towards the planned resubmission of our BLA
for narsoplimab in TA-TMA. We have submitted to FDA a formal
statistical plan for analysis of survival data available from an
already-identified external source of TA-TMA patient data. In
parallel, we continue to compile and revise the modules of our BLA
for resubmission. Assuming favorable feedback on our formal plan
for analysis of external survival data, we expect that the BLA
could be completed and resubmitted within a timeframe that,
allowing for the full FDA review period of six months, would result
in FDA rendering an approval decision in mid-2024.
- In October 2023, we announced preliminary results of the
pre-specified interim analysis of our Phase 3 ARTEMIS-IGAN trial
evaluating narsoplimab for the treatment of IgA nephropathy.
Topline results showed that narsoplimab did not reach statistically
significant improvement over placebo on the primary endpoint of
reduction in proteinuria assessed by 24-hour urine protein
excretion at 36 weeks in the intent-to-treat population of 180 IgA
nephropathy patients with baseline proteinuria above 2 grams per
day. Although the narsoplimab-treated group reported substantial
proteinuria improvement, the proteinuria improvement in the placebo
group was substantially greater than in reported Phase 3 clinical
trials assessing other agents for IgA nephropathy. Based on the
absence of a statistically significant improvement, and as
previously agreed with FDA, the ARTEMIS-IGAN clinical trial has
been discontinued.
- An abstract detailing compassionate-use treatment with
narsoplimab of 15 adult and pediatric patients with TA-TMA, 14 of
whom had “high-risk” TA-TMA, has been accepted for presentation at
the ASH annual meeting to be held in December 2023. The poster will
be presented by Dr. Marta Castelli, Department of Oncology and
Hematology, University of Milan and Azienda Socio-Sanitaria
Territoriale Papa Giovanni XXIII, Bergamo, Italy.
- A manuscript describing the pulmonary and central nervous
system benefits of MASP-2 blockade on symptoms and survival in
well-established animal models of COVID-19-related acute
respiratory distress syndrome (“ARDS”) was published in October in
the Journal of Infectious Diseases. 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 is completed in the first cohort of our ongoing Phase 1
multiple-ascending-dose (“MAD”) study of OMS1029 in healthy
subjects. In a single-ascending-dose Phase 1 clinical trial
completed in early 2023, as in the ongoing MAD study, 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. PK/PD data from the MAD study are expected in
the first part of 2024. A Phase 2 program is slated to begin next
summer in a larger market indication.
- 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 has been completed 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. Data are expected to be shared publicly later this year or
early next.
- Our clinical program evaluating OMS906 in patients with
complement 3 glomerulopathy (“C3G”) is also underway and is
expected to begin enrolling C3G patients next month.
- We have initiated an extension study to assess the long-term
safety and tolerability of OMS906 in patients with PNH. Enrolled
patients who have completed one of our two Phase 2 PNH studies
evaluating OMS906 will move directly into the extension study
without interruption of treatment. Data from this study will
support a planned BLA for OMS906 in PNH.
- Initiation of Phase 3 programs for OMS906 in PNH and C3G are
targeted for the third quarter of 2024.
- An abstract with new and updated data from our Phase 2 study of
OMS906 in treatment-naive PNH patients has been accepted for podium
presentation at the upcoming ASH annual meeting. The presentation
describes the clinically meaningful and beneficial effects of
OMS906 on hemoglobin with restoration of gender normal levels, on
lactate dehydrogenase, and on red blood cell clone size in PNH
patients.
- An abstract providing in vitro and in vivo mechanistic support
for the clinical efficacy of OMS906 observed in treatment-naïve PNH
patients will also be presented at the ASH annual meeting.
- To date across all clinical studies with OMS906, the drug has
been well tolerated and has demonstrated no safety signals of
concern.
- Recent developments regarding OMS527, our phosphodiesterase 7
(“PDE7”) inhibitor program focused on addictions and compulsive
disorders as well as 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 a three-year,
$6.69 million grant from NIDA and 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. We expect the
preclinical interaction study to begin in early 2024. Previously, a
Phase 1 clinical trial of the study drug in healthy subjects was
successfully completed.
- Together 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 (“L-DOPA”), the most prescribed treatment
for the over 10 million patients with Parkinson’s disease
worldwide. LID is reported to affect approximately 50 percent of
Parkinson's patients who have been treated for five or more years
with L-DOPA. The only approved treatment for LID is marginally
effective and fraught with safety issues.
- Recent developments regarding OMIDRIA®, our former
ophthalmologic product used in cataract surgery on which we receive
royalties on worldwide net sales by Rayner Surgical include the
following:
- The Centers for Medicare and Medicaid Services (“CMS”) issued
its 2024 Hospital Outpatient Prospective Payment System final rule
in October 2024. In that rule, CMS recommitted to separate payment
for OMIDRIA in ambulatory surgery centers (“ASCs”) throughout 2024.
As mandated by Congress in this year’s Consolidated Appropriations
Act, CMS, beginning January 1, 2025, will separately pay for
OMIDRIA in both hospital outpatient departments and in ASCs until
at least January 1, 2028.
Financial Results
Net loss was $37.8 million in the quarter ended September 30,
2023, or $0.60 per share, compared to a net loss in the prior year
quarter of $17.5 million, or $0.28 per share. The increase in the
current year quarter net loss was primarily attributable to an
incremental $18.9 million gain in discontinued operations in the
prior year quarter due to remeasurement of the contract royalty
asset. Excluding the incremental gain, net loss for the prior year
quarter would have been $36.4 million. Net loss from continuing
operations was $51.7 million in the current quarter compared to a
net loss of $54.8 million in the prior year quarter. Cash burn for
the quarter ending September 30, 2023 was $31.0 million.
For the nine months ended September 30, 2023, our net loss was
$108.8 million, or $1.73 per share compared to $81.3 million, or
$1.30 per share, in the prior year period. Net loss from continuing
operations for the nine months ended September 30, 2023 was $135.6
million compared to a loss of $136.0 million in the prior year
period.
For the third quarter of 2023, we earned OMIDRIA royalties of
$10.0 million on Rayner Surgical’s U.S. net sales of $33.3 million.
This compares to earned royalties of $16.5 million during the third
quarter of the prior year on U.S. net sales of $33.0 million. The
difference in earned royalties reflects the decrease from 50
percent to 30 percent in the base royalty rate applicable to U.S.
net sales of OMIDRIA, which occurred in December 2022 upon
achievement of the $200.0 million milestone payment event. The
royalty rate applicable to any sales outside the U.S. remains
unchanged at 15 percent. Royalties are recorded as a reduction of
the OMIDRIA contract royalty asset on our balance sheet.
Total costs and expenses for the third quarter of 2023 were
$48.2 million compared to $50.8 million for the third quarter of
2022. The decrease was primarily due to reduction in clinical trial
costs. This reduction was partially offset by increases in selling,
general and administrative expenses.
Interest expense during the third 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 royalty obligation
associated with the sale of a portion of our OMIDRIA royalty
receivables, an arrangement which we entered into at the end of
September 2022.
During the third quarter of 2023, we earned $4.4 million in
interest and other income compared to $0.9 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 $13.9
million, or $0.22 per share, in the third quarter of 2023 compared
to $37.3 million, or $0.59 per share, in the third quarter of 2022.
The decrease in the current year quarter was primarily attributable
to an incremental $18.9 million gain in discontinued operations in
the prior year quarter due to the remeasurement of the contract
royalty asset.
As of September 30, 2023, we had $310.3 million of cash and
short-term investments, all of which are held in our name,
available for operations and debt service.
On November 15, 2023, the $95.0 million outstanding on the 2023
unsecured convertible senior notes will become due. We anticipate
retiring the notes at maturity with available cash and
investments.
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 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. Omeros’
long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1
multi-ascending-dose clinical trial. OMS906, Omeros’ inhibitor of
MASP-3, the key activator of the alternative pathway of complement,
is advancing in clinical programs for paroxysmal nocturnal
hemoglobinuria and complement 3 glomerulopathy. Funded by the
National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7
inhibitor OMS527 is in clinical development for the treatment of
cocaine use disorder and, in addition, is being developed as a
therapeutic for other addictions as well as for a major
complication of treatment for movement disorders. Omeros also is
advancing a broad portfolio of novel immuno-oncology programs
comprised of two cellular and three molecular platforms. 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
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Costs and expenses:
Research and development
$
31,731
$
38,568
$
85,980
$
86,172
Selling, general and administrative
16,422
12,198
38,785
37,079
Total costs and expenses
48,153
50,766
124,765
123,251
Loss from operations
(48,153
)
(50,766
)
(124,765
)
(123,251
)
Interest expense
(7,916
)
(4,932
)
(23,781
)
(14,799
)
Interest and other income
4,413
906
12,913
2,069
Net loss from continuing operations
(51,656
)
(54,792
)
(135,633
)
(135,981
)
Net income from discontinued operations,
net of tax
13,906
37,336
26,888
54,665
Net loss
$
(37,750
)
$
(17,456
)
$
(108,745
)
$
(81,316
)
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.82
)
$
(0.87
)
$
(2.16
)
$
(2.17
)
Net income from discontinued
operations
0.22
0.59
0.43
0.87
Net loss
$
(0.60
)
$
(0.28
)
$
(1.73
)
$
(1.30
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,856,721
62,730,015
62,840,990
62,728,276
OMEROS CORPORATION UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEET (In thousands)
September 30,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
30,640
$
11,009
Short-term investments
279,670
183,909
OMIDRIA contract royalty asset,
short-term
29,228
28,797
Receivables
6,878
213,221
Prepaid expense and other assets
4,922
6,300
Total current assets
351,338
443,236
OMIDRIA contract royalty asset
119,502
123,425
Right of use assets
19,460
21,762
Property and equipment, net
1,717
1,492
Restricted investments
1,054
1,054
Total assets
$
493,071
$
590,969
Liabilities and shareholders’ equity
(deficit)
Current liabilities:
Accounts payable
$
5,866
$
5,989
Accrued expenses
34,859
30,551
Current portion of unsecured convertible
senior notes, net
94,909
94,381
Current portion of OMIDRIA royalty
obligation
6,654
1,152
Current portion of lease liabilities
4,888
4,310
Total current liabilities
147,176
136,383
Unsecured convertible senior notes,
net
221,828
220,906
OMIDRIA royalty obligation
118,770
125,126
Lease liabilities, non-current
19,249
22,426
Other accrued liabilities, non-current
—
444
Shareholders’ equity (deficit):
Common stock and additional paid-in
capital
730,510
721,401
Accumulated deficit
(744,462
)
(635,717
)
Total shareholders’ equity (deficit)
(13,952
)
85,684
Total liabilities and shareholders’
equity (deficit)
$
493,071
$
590,969
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109691381/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
Omeros (NASDAQ:OMER)
過去 株価チャート
から 5 2024 まで 6 2024
Omeros (NASDAQ:OMER)
過去 株価チャート
から 6 2023 まで 6 2024