Webcast including Research & Technology
Event begins at 11:00 a.m. Eastern time today
OmniAb, Inc. (NASDAQ: OABI) today reported financial
results for the three and nine months ended September 30, 2023, and
provided operating and partner program updates.
“Our business momentum has continued with the recent addition of
three new partners including another global pharma company. Despite
macroeconomic conditions, OmniAb’s partner portfolio has continued
to grow this year with a total of 314 active partner programs as of
quarter-end, up from 291 at the beginning of the year ” said Matt
Foehr, Chief Executive Officer of OmniAb. “We look forward to
highlighting our commitment to technology innovation and to serving
the current and future needs of our partners at our first Research
& Technology Virtual Event later today, which will include an
overview of our new OmnidAb™ technology.”
Third Quarter 2023 Financial Results
Revenue for the third quarter of 2023 was $5.5 million, compared
with $6.9 million for the same period in 2022, with the decrease
primarily driven by lower service revenue as a result of the
completion of discovery work on certain ion channel programs.
Research and development expense was $13.9 million for the third
quarter of 2023, compared with $13.2 million for the same period in
2022, with the increase primarily due to higher personnel costs.
General and administrative expense was $8.5 million for the third
quarter of 2023, compared with $5.6 million for the same period in
2022, with the increase primarily due to higher personnel costs and
expenses related to being an independent publicly traded
company.
Net loss for the third quarter of 2023 was $15.7 million, or
$0.16 per share, compared with a net loss of $12.6 million, or
$0.15 per share, for the same period in 2022.
Year-to-Date Financial Results
Revenue for the nine months ended September 30, 2023 was $29.3
million, compared with $23.7 million for the same period in 2022.
Milestone revenue was higher, 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 and progress
with the batoclimab program. Service revenue was lower primarily
related to the completion of work on certain ion channel programs
and a one-time adjustment related to the extension of one of our
programs with GSK, partially offset by the recognition of a portion
of a research progression milestone.
Research and development expense was $41.8 million for the nine
months ended September 30, 2023, compared with $35.4 million for
the same period in 2022, with the increase primarily due to higher
personnel and facility costs. General and administrative expense
was $25.4 million for the nine months ended September 30, 2023,
compared with $14.7 million for the same period in 2022, with the
increase primarily due to higher personnel costs and expenses
related to being an independent publicly traded company.
Net loss for the nine months ended September 30, 2023 was $36.6
million, or $0.37 per share, compared with a net loss of $29.2
million, or $0.35 per share, for the same period in 2022.
As of September 30, 2023, OmniAb had cash, cash equivalents and
short-term investments of $96.6 million. Given delays in the timing
of certain partner program milestones, the Company now expects its
cash, cash equivalents and short-term investments balance at
year-end 2023 to be slightly lower than at year-end 2022. Current
cash, cash equivalents and short-term investments, along with the
cash OmniAb 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.
Third Quarter 2023 and Recent Business Highlights
During the third quarter of 2023 and recent weeks, OmniAb
entered into three new license agreements including GigaMune,
Polaris Therapeutics, Inc. and, most recently, Novartis. These
additions of GigaMune and Polaris bring the total active partner
count to 76 as of September 30, 2023.
Programs by OmniAb’s partners continued to progress during the
quarter, including two entering the clinic. Roche’s HLA-Gx CD3
bispecific to treat advanced or metastatic solid tumors expressing
human leukocyte antigen G, and Cessation Therapeutics’ CSX-1004, a
monoclonal antibody designed specifically to prevent fentanyl
overdose, initiated Phase 1 clinical trials.
As of September 30, 2023, the Company’s partners had a total of
314 active programs, including three approved drugs, one under
regulatory review and 27 in various stages of clinical
development.
Third quarter 2023 and recent partner highlights include the
following:
Batoclimab
- HanAll Biopharma announced initiation of a Phase 3 clinical
study in Japan of batoclimab for the treatment of generalized
myasthenia gravis in Japan.
IMVT-1402
- Immunovant announced in initial data from a Phase 1 clinical
trial in healthy adults that subcutaneously administered IMVT-1402
produced dose-dependent reductions in IgG, with no dose-related
changes in serum albumin or LDL-C, bolstering IMVT-1402 as a
potential best-in-class neonatal fragment crystallizable receptor
(FcRn) inhibitor.
CSX-1004
- Cessation Therapeutics’ announced initiation of a Phase 1
clinical study of CSX-1004, a monoclonal antibody designed
specifically to prevent fentanyl overdose and that the U.S. Food
and Drug Administration (FDA) has granted Fast Track designation to
CSX-1004.
Zimberelimab
- Gloria Pharmaceuticals announced receipt of marketing approval
for Zimberelimab (YuTuo®, GLS-010) from China’s National Medical
Products Administration (NMPA) as monotherapy for the treatment of
recurrent or metastatic cervical cancer in patients with positive
PD-L1 expression (CPS≥1) who progressed on or after platinum-based
chemotherapy. Zimberelimab is the first and only immune checkpoint
inhibitor antibody approved in China for cervical cancer, and the
third one globally.
- At the American Society of Clinical Oncology Monthly Plenary
Series, Arcus presented data from cohort A1 of the ongoing Phase 2
EDGE-Gastric study (also known as ARC-21), a collaboration between
Arcus and Gilead Sciences. The Phase 2 study is evaluating various
combinations of domvanalimab, an Fc-silent anti-TIGIT monoclonal
antibody, and zimberelimab, an anti-PD-1 antibody, in patients with
locally advanced unresectable or metastatic gastric,
gastroesophageal junction or esophageal adenocarcinoma.
Sugemalimab
- CStone announced NMPA approval of sugemalimab for patients with
relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL),
which is the first anti-PD-1/PD-L1 monoclonal antibody approved for
this indication.
- CStone also announced that the Phase 3 GEMSTONE-303
registrational trial of sugemalimab in combination with
chemotherapy as a first-line treatment for unresectable locally
advanced or metastatic gastric or gastroesophageal junction
adenocarcinoma with PD-L1 expression ≥5% met its primary endpoint,
demonstrating statistically significant and clinically meaningful
improvements in overall survival compared with placebo plus
chemotherapy. The safety profile was consistent with previous
reports of sugemalimab studies and no new safety signals were
identified.
OmniAb recently appointed Steve Love to its Board of Directors.
Mr. Love has more than 30 years of financial experience including
more than 13 years serving in Chief Financial Officer positions,
and will serve on OmniAb’s Audit Committee as Chair. Mr. Love is
currently the Chief Financial Officer of Heap Inc., a machine
learning-enabled digital analytics software company. Prior to Heap,
Mr. Love spent nearly 30 years in finance leading the growth
strategy and data-driven decision making at Juniper Square Inc.,
Dialpad Inc., Mblox Inc., Affymax, Inc. and Connetics Corporation,
among other companies.
To continue enhancing its innovation and technology development
capabilities, OmniAb named Yasmina Abdiche, Ph.D. as Vice President
of Exploratory Research. Dr. Abdiche has nearly 20 years of protein
engineering and biopharma industry experience focused on the
application of analytical biosensor technologies and label-free
interaction analysis in early-stage drug discovery. Dr. Abdiche
joined OmniAb from FairJourney Biologics, where she served as Chief
Technology Officer.
Webcast Including Research & Technology Event
OmniAb management will review third quarter 2023 financial
results as part of a Research & Technology virtual event being
held today at 11:00 a.m. Eastern time. The event will feature a
review of the Company’s latest technology offerings led by members
of OmniAb’s senior management. Interested parties are requested to
register in advance at here. The live and archived webcast, along
with slides will be available on the Investors portion of OmniAb’s
website.
About OmniAb®
OmniAb’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 through a common light chain
approach, and OmniTaur™ features unique structural attributes of
cow antibodies for complex targets. OmnidAbTM is an in vivo
platform for single domain antibodies based upon a human VH
scaffold that affinity matures in a chicken host environment to
provide a functionally diverse immune repertoire unavailable from
mammalian systems. 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. These
proprietary technologies are joined with and leverage OmniDeepTM,
which is a suite of in silico tools for therapeutic discovery and
optimization that are woven throughout OmniAb’s various
technologies and capabilities. Additionally, an established core
competency focused on ion channels and transporters further
differentiates OmniAb’s technology and creates opportunities in
many 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 and the
discovery needs of the pharmaceutical industry; the expected
performance of, our technologies and the opportunities they may
create; 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 and technologies
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, 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.
OMNIAB, INC.
CONDENSED CONSOLIDATED AND
COMBINED BALANCE SHEETS
(in thousands, except share and
per share data)
September 30, 2023
December 31, 2022
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
21,245
$
33,390
Short-term investments
75,383
54,875
Accounts receivable, net
6,137
30,290
Prepaid expenses and other current
assets
4,083
6,395
Total current assets
106,848
124,950
Intangible assets, net
158,773
167,242
Goodwill
83,979
83,979
Property and equipment, net
18,514
19,979
Operating lease right-of-use assets
20,400
21,483
Other long-term assets
3,194
3,579
Total assets
$
391,708
$
421,212
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,501
$
2,971
Accrued expenses and other current
liabilities
6,517
5,557
Income tax payable
3,455
3,485
Current contingent liabilities
1,753
4,022
Current deferred revenue
7,382
8,207
Current operating lease liabilities
3,452
1,780
Total current liabilities
25,060
26,022
Long-term contingent liabilities
3,519
4,089
Deferred income taxes, net
13,874
21,341
Long-term operating lease liabilities
22,724
24,016
Long-term deferred revenue
1,946
4,325
Other long-term liabilities
36
46
Total liabilities
67,159
79,839
Stockholders' equity:
Preferred stock, $0.0001 par value;
100,000,000 shares authorized at September 30, 2023 and December
31, 2022; no shares issued and outstanding at September 30, 2023
and December 31, 2022
—
—
Common stock, $0.0001 par value;
1,000,000,000 shares authorized at September 30, 2023 and December
31, 2022; 116,231,999 and 115,218,229 shares issued and outstanding
at September 30, 2023 and December 31, 2022, respectively
12
12
Additional paid-in capital
349,900
330,100
Accumulated other comprehensive (loss)
income
(49
)
9
(Accumulated deficit) Retained
earnings
(25,314
)
11,252
Total stockholders’ equity
324,549
341,373
Total liabilities and stockholders’
equity
$
391,708
$
421,212
OMNIAB, INC.
CONDENSED CONSOLIDATED AND
COMBINED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share
data)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenues:
License and milestone revenue
$
2,010
$
1,400
$
18,986
$
7,826
Service revenue
3,016
4,928
9,425
14,922
Royalty revenue
451
582
931
984
Total revenues
5,477
6,910
29,342
23,732
Operating expenses:
Research and development
13,867
13,189
41,759
35,445
General and administrative
8,511
5,582
25,444
14,697
Amortization of intangibles
3,398
3,256
10,147
9,774
Other operating expense (income), net
16
(208
)
205
(486
)
Total operating expenses
25,792
21,819
77,555
59,430
Loss from operations
(20,315
)
(14,909
)
(48,213
)
(35,698
)
Other income:
Interest income
1,265
—
3,874
—
Other income, net
8
—
4
—
Total other income, net
1,273
—
3,878
—
Loss before income taxes
(19,042
)
(14,909
)
(44,335
)
(35,698
)
Income tax benefit
3,304
2,313
7,769
6,544
Net loss
$
(15,738
)
$
(12,596
)
$
(36,566
)
$
(29,154
)
Net loss per share, basic and diluted
$
(0.16
)
$
(0.15
)
$
(0.37
)
$
(0.35
)
Weighted-average shares outstanding, basic
and diluted
99,905
82,612
99,521
82,612
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109965464/en/
OmniAb, Inc. Neha Singh, Ph.D. investors@OmniAb.com Twitter
@OmniAbTech (510) 768-7760
OmniAb (NASDAQ:OABI)
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