Conference Call with Slides Begins at 8:30
a.m. Eastern Time Today
OmniAb, Inc. (NASDAQ: OABI) today reported financial
results for the three months ended March 31, 2023, and provided
operating and partner program updates.
“Our first quarter performance is a strong start to the year. We
reached 301 active programs, with 27 in clinical development or
approved for commercialization as our growing portfolio of partner
programs continued to advance,” said Matt Foehr, Chief Executive
Officer of OmniAb, Inc. “Innovating our technologies is part of our
strategy, and we are proud to introduce OmniDeep™ at next week’s
PEGS Protein Engineering Conference and Expo in Boston. OmniDeep is
a suite of proprietary in silico tools that have been a part of our
internal research efforts for many years and that we’ve recently
expanded. These tools are now more broadly available to our
partners and facilitate rapid identification of lead candidates
leveraging our large multi-species antibody databases and the
Biological Intelligence™ of our proprietary transgenic
animals.”
First Quarter 2023 Financial Results
Revenue for the first quarter of 2023 was $16.9 million,
compared with $9.6 million for the same period in 2022, with the
increase primarily due to the recognition of a $10.0 million
milestone payment related to the first commercial sale of TECVAYLI®
(teclistamab) in the European Union.
Research and development expense was $13.8 million for the first
quarter of 2023, compared with $10.8 million for the same period in
2022, with the increase primarily due to investments in facilities,
headcount, and technology innovation. General and administrative
expense was $8.2 million for the first quarter of 2023, compared
with $4.1 million for the same period in 2022, with the increase
primarily due to higher headcount and other expenses related to
being an independent publicly traded company.
Net loss for the first quarter of 2023 was $6.1 million, or
$0.06 per share, compared with a net loss of $6.3 million, or $0.08
per share, for the same period in 2022.
As of March 31, 2023, OmniAb had cash, cash equivalents, and
short-term investments of $113.6 million. The Company expects its
year-end 2023 cash, cash equivalents and short-term investments
balance to be slightly higher than year-end 2022. Current cash,
cash equivalents and short-term investments, along with the cash
the Company generates from operations, are expected to be
sufficient to fund operations for the foreseeable future.
On November 1, 2022, OmniAb completed a spin-off from Ligand
Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb
becoming an independent publicly traded company. Financial results
prior to November 1, 2022, are presented on a carve-out basis
derived from Ligand’s historical accounting records, as if OmniAb
were an independent company.
First Quarter 2023 and Recent Business Highlights
In the first quarter of 2023, the Company entered into a license
and revenue-sharing agreement with The Scripps Research Institute
related to OmniRat®-derived programs that are being advanced by
Cessation Therapeutics, Inc. In addition, subsequent to the end of
the quarter, OmniAb signed a platform license agreement with
Neurocrine Biosciences.
Our partners’ programs continued to progress in the first
quarter, including Seagen’s bispecific molecule SGN-BB228 to treat
advanced melanoma and other solid tumors entering the clinic. As of
March 31, 2023, the Company had 70 active partners with 27
OmniAb-derived programs in clinical development or being
commercialized, and a total of 301 programs being pursued or
commercialized.
First quarter 2023 and recent partner highlights include the
following:
Batoclimab
- Immunovant announced that it expects to report initial results
from its Phase 2 clinical trial in Graves’ disease in the second
half of 2023. In addition, Immunovant is running clinical trials in
generalized myasthenia gravis, thyroid eye disease and chronic
inflammatory demyelinating polyneuropathy.
IMVT-1402
- Immunovant announced plans to initiate a Phase 1 clinical trial
of its next-generation anti-FcRn, IMVT-1402, in autoimmune
diseases, contingent on clearance of its Investigational New Drug
application. As with batoclimab, in nonclinical studies IMVT-1402
has been observed to reduce IgG antibody levels and is designed to
enable a subcutaneous route of administration delivered in a matter
of seconds. Additionally, in animal studies IMVT-1402 has been
observed to have minimal or no impact on albumin and LDL
levels.
SGN-BB228
- Seagen announced initiation of a first-in-human Phase 1
clinical trial of SGN-BB228 in advanced melanoma and other solid
tumors. SGN-BB228 is a first-in-class CD228-targeted costimulatory
antibody Anticalin bispecific delivering potent and conditional
4-1BB costimulation to intratumoral T cells. This fully human IgG4
monoclonal antibody is designed to provide a potent signal between
tumor-reactive cytotoxic T cells and CD228-expressing tumor cells,
improving and constraining T cell-mediated cytotoxicity in tumors,
potentially expanding the therapeutic window for 4-1BB
agonism.
Sugemalimab
- CStone announced submission of a supplemental biologics
application (sBLA) to China’s National Medical Products
Administration for sugemalimab in combination with chemotherapy as
a first-line treatment of unresectable locally advanced, recurrent
or metastatic esophageal squamous cell carcinoma. The sBLA
application is based on the GEMSTONE-304 study, which met its
primary endpoints in January 2023.
- CStone reported publication of GEMSTONE-201 study results for
sugemalimab monotherapy in the treatment of relapsed/refractory
extranodal NK/T-cell lymphoma and announced it expects a decision
on its pending new drug application in the second half of 2023 in
mainland China. CStone also announced a decision on its
supplemental new drug application for first-line treatment in
gastric adenocarcinoma/gastroesophageal junction adenocarcinoma is
expected in the second half of 2023 or the first half of 2024 in
mainland China.
- CStone announced that it will regain rights for the development
and commercialization of sugemalimab outside of Greater China from
EQRx. CStone will now lead the regulatory process for the Marketing
Authorization Applications by the European Medicines Agency and the
Medicines and Healthcare products Regulatory Agency in the United
Kingdom.
OmniAb will be highlighting some of its new technology at the
19th Annual PEGS Boston Conference and Expo, including a
presentation on its OmniDeep platform at 1:10 p.m. Eastern time on
Wednesday, May 17, 2023. OmniDeep is a suite of in silico tools for
therapeutic discovery and optimization that are woven throughout
OmniAb’s various technologies and capabilities. These tools include
structural modeling, molecular dynamics simulations, large
multi-species antibody databases, AI, machine learning, deep
learning models and more. OmniDeep facilitates rapid identification
of candidates with the right affinity, specificity and
developability profiles, to make drug development more effective
and efficient.
The Company also expects that multiple partners will be
presenting data from programs developed with OmniAb technology at
the American Society of Clinical Oncology Annual Meeting taking
place June 2-6.
Conference Call and Webcast
OmniAb management will host a conference call with slides today
beginning at 8:30 a.m. Eastern time to discuss this announcement
and answer questions. To participate via telephone, please dial
(888) 886-7786 using the conference ID 36818707. Slides, as well as
the live and replay webcast of the call, are available at
https://investors.omniab.com/investors/events-and-presentations/default.aspx.
About OmniAb®
OmniAb, Inc.’s discovery platform provides pharmaceutical
industry partners access to diverse antibody repertoires and
high-throughput screening technologies to enable discovery of
next-generation therapeutics. At the heart of the OmniAb platform
is the Biological Intelligence™ (BI) of our proprietary transgenic
animals, including OmniRat®, OmniChicken® and OmniMouse® that have
been genetically modified to generate antibodies with human
sequences to facilitate development of human therapeutic
candidates. OmniFlic® (transgenic rat) and OmniClic® (transgenic
chicken) address industry needs for bispecific antibody
applications though a common light chain approach, and OmniTaur™
features unique structural attributes of cow antibodies for complex
targets. We believe the OmniAb animals comprise the most diverse
host systems available in the industry and they are optimally
leveraged through computational antigen design and immunization
methods, paired with high-throughput single B cell phenotypic
screening and mining of next-generation sequencing datasets with
custom algorithms to identify fully human antibodies with superior
performance and developability characteristics. An established core
competency focused on ion channels and transporters further
differentiates our technology and creates opportunities in emerging
target classes. OmniAb antibodies have been leveraged across
modalities, including bispecific antibodies, antibody-drug
conjugates and others. The OmniAb suite of technologies span from
BI-powered repertoire generation to cutting-edge antibody discovery
and optimization offering a highly efficient and customizable
end-to-end solution for the growing discovery needs of the global
pharmaceutical industry.
For more information, please visit www.omniab.com.
Forward-Looking Statements
OmniAb cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. Words such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,” “target,”
“project,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential” or continue” and similar expressions, are intended to
identify forward-looking statements. The forward-looking statements
are based on our current beliefs and expectations and include, but
are not limited to: the growth prospects of our business; continued
innovation around, and the expected performance of, our
technologies; the ability to add new partners and programs;
scientific presentations and clinical and regulatory events of our
partners and the timing thereof; expected cash runway; and the
future balance of cash, cash equivalents and short-term
investments. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in our
business, including, without limitation: our future success is
dependent on acceptance of our technology platform by new and
existing partners, as well as on the eventual development, approval
and commercialization of products developed by our partners for
which we have no control over the development plan, regulatory
strategy or commercialization efforts; biopharmaceutical
development is inherently uncertain; risks arising from changes in
technology; the competitive environment in the life sciences and
biotechnology platform market; our failure to maintain, protect and
defend our intellectual property rights; difficulties with
performance of third parties we will rely on for our business;
regulatory developments in the United States and foreign countries;
unstable market and economic conditions, including adverse
developments with respect to financial institutions and associated
liquidity risk, may have serious adverse consequences on our
business, financial condition and stock price; we may use our
capital resources sooner than we expect; and other risks described
in our prior press releases and filings with the SEC, including
under the heading “Risk Factors” in the our annual report on Form
10-K and any subsequent filings with the SEC. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and we undertake no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary
statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
Partner Information
The information in this press release regarding partnered
products and programs comes from information publicly released by
our partners.
[Tables Follow]
OMNIAB, INC.
CONDENSED CONSOLIDATED AND
COMBINED BALANCE SHEETS
(Unaudited)
(in thousands, except share and
per share data)
March 31, 2023
December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents
$
22,906
$
33,390
Short-term investments
90,699
54,875
Accounts receivable, net
1,819
30,290
Prepaid expenses and other current
assets
5,657
6,395
Total current assets
121,081
124,950
Intangible assets, net
164,355
167,242
Goodwill
83,979
83,979
Property and equipment, net
19,307
19,979
Operating lease right-of-use assets
20,979
21,483
Other long-term assets
3,340
3,579
Total assets
$
413,041
$
421,212
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable
$
2,485
$
2,971
Accrued expenses and other current
liabilities
3,909
5,557
Income tax payable
3,486
3,485
Current contingent liabilities
2,471
4,022
Current deferred revenue
6,886
8,207
Current operating lease liabilities
2,440
1,780
Total current liabilities
21,677
26,022
Long-term contingent liabilities
3,683
4,089
Deferred income taxes, net
20,400
21,341
Long-term operating lease liabilities
23,418
24,016
Long-term deferred revenue
3,017
4,325
Other long-term liabilities
44
46
Total liabilities
72,239
79,839
Stockholders' equity:
Preferred stock, $0.0001 par value;
100,000,000 shares authorized at March 31, 2023 and December 31,
2022; no shares issued and outstanding at March 31, 2023 and
December 31, 2022
—
—
Common stock, $0.0001 par value;
1,000,000,000 shares authorized at March 31, 2023 and December 31,
2022; 115,584,520 and 115,218,229 shares issued and outstanding at
March 31, 2023 and December 31, 2022, respectively
12
12
Additional paid-in capital
335,631
330,100
Accumulated other comprehensive income
7
9
Retained earnings
5,152
11,252
Total stockholders’ equity
340,802
341,373
Total liabilities and stockholders’
equity
$
413,041
$
421,212
OMNIAB, INC.
CONDENSED CONSOLIDATED AND
COMBINED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share
data)
Three Months Ended March
31,
2023
2022
Revenues:
License and milestone revenue
$
12,646
$
4,101
Service revenue
3,958
5,259
Royalty revenue
315
263
Total revenues
16,919
9,623
Operating expenses:
Research and development
13,759
10,772
General and administrative
8,195
4,112
Amortization of intangibles
3,369
3,405
Other operating expense (income), net
49
(443
)
Total operating expenses
25,372
17,846
Loss from operations
(8,453
)
(8,223
)
Other income:
Interest income
1,324
—
Total other income
1,324
—
Loss before income taxes
(7,129
)
(8,223
)
Income tax benefit
1,029
1,941
Net loss
$
(6,100
)
$
(6,282
)
Net loss per share, basic and diluted
$
(0.06
)
$
(0.08
)
Weighted-average shares outstanding, basic
and diluted
99,158
82,612
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005316/en/
OmniAb, Inc. Neha Singh, Ph.D. investors@OmniAb.com Twitter
@OmniAbTech (510) 768-7760
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