Conference Call with Slides Begins at 4:30
p.m. Eastern Time Today
OmniAb, Inc. (NASDAQ: OABI) today reported financial
results for the three and nine months ended September 30, 2024, and
provided operating and partner program updates.
“We are pleased to report another successful quarter
demonstrating our continued commitment to innovation with the
expansion of our technology platform and a growing partnership
portfolio. Third quarter results reflect consistent growth across
key metrics, driven by our planned initiatives and the dedication
of our team,” said Matt Foehr, Chief Executive Officer of OmniAb.
“Our business is well capitalized, and we have a highly scalable
model with cutting-edge technologies that are driving significant
opportunities. As we move forward, we remain focused on delivering
value to our stakeholders and creating sustainable, profitable
growth.”
Third Quarter 2024 Financial Results
Revenue for the third quarter of 2024 was $4.2 million, compared
with $5.5 million for the same period in 2023, with the decrease
primarily due to timing of milestones and lower ion channel service
revenue.
Research and development expense was $13.3 million for the third
quarter of 2024, compared with $13.9 million for the same period in
2023, with the decrease primarily due to lower share-based
compensation expense. General and administrative expense was $7.1
million for the third quarter of 2024, compared with $8.5 million
for the same period in 2023, with the decrease primarily due to
lower legal and share-based compensation expense.
Net loss for the third quarter of 2024 was $16.4 million, or
$0.16 per share, compared with a net loss of $15.7 million, or
$0.16 per share, for the same period in 2023.
Year-to-Date Financial Results
Revenue for the nine months ended September 30, 2024 was $15.6
million, compared with $29.3 million for the same period in 2023,
due to lower milestone revenue primarily related to a $10 million
milestone in the prior year period for the first commercial sale of
TECVAYLI® (teclistamab) in the European Union.
Research and development expense was $41.8 million for the nine
months ended September 30, 2024, which was unchanged from the same
period in 2023. General and administrative expense was $23.4
million for the nine months ended September 30, 2024, compared with
$25.4 million for the same period in 2023, with the decrease
primarily due to lower outside service expenses. Amortization of
intangible assets increased for the nine months ended September 30,
2024, primarily due to a $1.2 million impairment related to assets
associated with two legacy unpartnered Ab Initio programs. Other
operating income, net increased for the nine months ended September
30, 2024, primarily due to a $2.4 million reduction in contingent
liabilities attributed to changes in ion channel programs.
Net loss for the nine months ended September 30, 2024 was $49.0
million, or $0.48 per share, compared with a net loss of $36.6
million, or $0.37 per share, for the same period in 2023.
As of September 30, 2024, OmniAb had cash, cash equivalents and
short-term investments of $59.4 million.
During the third quarter of 2024, OmniAb sold 2.0 million shares
of common stock through its at-the-market (ATM) program pursuant to
the sales agreement with Jefferies. The net proceeds from these
sales were $8.5 million.
Subsequent to the end of the third quarter, OmniAb sold 0.7
million shares of common stock through its ATM program for net
proceeds of $2.9 million, which will be reflected in its December
31, 2024 financial statements.
2024 Financial Guidance
OmniAb continues to expect total operating expenses in 2024 to
be slightly less than total operating expenses in 2023.
OmniAb now expects to end 2024 with a cash balance in the range
of $50 million to $60 million, which includes proceeds from its ATM
program. Given the current expected progression of the existing
partnered pipeline, OmniAb expects cash use in 2025 to be lower
than in 2024 excluding recent ATM program proceeds.
Third Quarter 2024 and Recent Business Highlights
During the third quarter of 2024, OmniAb entered into three new
platform license agreements including with 92Bio, Memorial Sloan
Kettering Cancer Center and Queen Mary University of London. In
addition, OmniAb recently expanded its ion channel screening
relationship with Syngenta that was initially established last
year. As of September 30, 2024, the Company had 86 active partners
and 352 active programs, including 33 OmniAb-derived programs in
clinical development or being commercialized. OmniAb also recently
entered into a new platform license agreement with Incyte
Corporation.
Third quarter 2024 and recent partner and business highlights
include the following:
IMVT-1402
- Immunovant announced that the Investigational New Drug (IND)
application has been cleared for IMVT-1402 in rheumatoid arthritis
(RA), with a potential best-in-class profile in difficult-to-treat
(D2T) RA.
- Immunovant announced that five IND applications for IMVT-1402
have been cleared across a range of therapeutic areas and U.S. Food
& Drug Administration divisions. The company also announced
that it is on track to initiate potentially registrational trials
with IMVT-1402 in four to five indications, including Graves’
disease (GD) and D2T RA, by March 31, 2025.
Batoclimab
- Immunovant reported positive results from the Phase 2a trial of
batoclimab in GD. High-dose batoclimab achieved a 76% response rate
and a 56% antithyroid drugs (ATD)-free response rate in patients
uncontrolled on ATDs at week 12.
- Immunovant announced that batoclimab trials in myasthenia
gravis and chronic inflammatory demyelinating polyneuropathy are
fully enrolled to support data disclosures by March 31, 2025. Data
from batoclimab trials in thyroid eye disease are now expected in
the second half of calendar year 2025. All batoclimab data will
inform future trials with IMVT-1402.
Acasunlimab
- Genmab announced that based on encouraging data from the Phase
2 trial in non-small cell lung cancer (NSCLC), a Phase 3 trial is
expected to start before the end date of 2024.
TEV-53408
- Teva recently disclosed Phase 1 data for TEV-53408 showing a
potential best-in-class profile noting high affinity for IL-15,
prolonged suppression of free IL-15, and potential for a low dosing
frequency. TEV-53408 was well tolerated in a first-in-human study,
and a proof-of-concept study in celiac disease is in progress.
Additionally, Teva disclosed the initiation of a clinical study in
vitiligo, an autoimmune disease.
Sugemalimab
- CStone announced that the UK Medicines and Healthcare products
Regulatory Agency (MHRA) has approved sugemalimab in combination
with platinum-based chemotherapy as a first-line treatment for
adult patients with metastatic NSCLC without EGFR-sensitive
mutations or ALK, ROS1, RET genomic alterations.
- CStone announced long-term survival data for sugemalimab in
combination with platinum-based chemotherapy as first-line
treatment of stage IV NSCLC at the European Society for Medical
Oncology (ESMO) Congress 2024. Four-year follow-up data showed that
sugemalimab plus platinum-based chemotherapy continues to
demonstrate a significant benefit in progression-free survival and
overall survival compared with placebo plus platinum-based
chemotherapy. The four-year survival rate was 32.1% versus
17.3%.
BC3195
- BioCity presented interim clinical results on the safety and
efficacy of its first-in-class antibody-drug conjugate BC3195,
which targets CDH3 (P-Cadherin), in a Phase 1 clinical trial at
ESMO 2024.
- As of the data cut-off date (August 10, 2024), BC3195
demonstrated impressive antitumor activity in patients with
advanced NSCLC with an overall response rate (ORR) of 36.4% (4 of
11 patients). The ORR was 80% (4 of 5 patients) in NSCLC with
epidermal growth factor receptor mutations. BC3195 demonstrated
manageable safety and tolerability, as well as favorable
pharmacokinetic characteristics.
- BC3195 is currently undergoing concurrent Phase 1
dose-optimization and dose-expansion studies in China.
Conference Call and Webcast
OmniAb management will host a conference call with accompanying
slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific
time) to discuss this announcement and answer questions. To
participate via telephone, please dial (800) 549 8228 using the
conference ID 94399. 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 licenses cutting edge discovery research technology to
the pharmaceutical and biotech industries and academic institutions
to enable the discovery of next-generation therapeutics. Our
technology platform creates and screens diverse antibody
repertoires and is designed to quickly identify optimal antibodies
and other target-binding proteins for our partners’ drug
development efforts. At the heart of the OmniAb platform is what we
call Biological Intelligence™ (BI), which powers the immune systems
of our proprietary, engineered transgenic animals to create
optimized antibody candidates for human therapeutics.
We believe the OmniAb animals comprise the most diverse host
systems available in the industry. Our suite of technologies and
methods, including 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, are used to identify fully-human antibodies with
exceptional performance and developability characteristics.
Our proprietary transgenic animals, including OmniRat®,
OmniChicken® and OmniMouse® have been genetically modified to
generate antibodies with human sequences to streamline the
development of human therapeutic candidates. OmniFlic® and
OmniClic® are fixed or common light-chain rats and chickens,
respectively, designed to facilitate the discovery of bispecific
antibodies. OmniTaur™ provides cow-inspired antibodies with unique
structural characteristics for challenging targets. OmnidAb™ is an
in vivo platform for the discovery of 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. Our proprietary
technologies are joined with and leverage OmniDeep™, which is a
suite of in silico, AI and machine learning tools for therapeutic
discovery and optimization that are woven throughout our 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 important and emerging target classes.
OmniAb technologies can be leveraged for the discovery of a
variety of next-generation antibody-based therapeutic modalities,
including bi- and multi-specific biologics, antibody-drug
conjugates, CAR-T therapies, targeted radiotherapeutics and many
others.
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 scalability of our business model; the
growth prospects of our business and the potential for it to be
sustainable and profitable; the expected performance and expansion
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; and expected operating expense, cash balance and cash
usage. 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
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 BALANCE
SHEETS
(in thousands, except share and
per share data)
September 30, 2024
December 31, 2023
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
27,236
$
16,358
Short-term investments
32,145
70,625
Accounts receivable, net
3,495
3,844
Prepaid expenses and other current
assets
3,733
4,074
Total current assets
66,609
94,901
Intangible assets, net
144,119
155,467
Goodwill
83,979
83,979
Property and equipment, net
16,333
18,249
Operating lease right-of-use assets
18,333
19,884
Restricted cash
560
560
Other long-term assets
1,621
2,185
Total assets
$
331,554
$
375,225
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,187
$
4,411
Accrued expenses and other current
liabilities
5,446
7,068
Current contingent liabilities
510
1,303
Current deferred revenue
2,508
6,848
Current operating lease liabilities
3,751
3,486
Total current liabilities
14,402
23,116
Long-term contingent liabilities
1,111
3,203
Deferred income taxes, net
4,131
11,354
Long-term operating lease liabilities
20,088
22,075
Long-term deferred revenue
41
862
Other long-term liabilities
53
30
Total liabilities
39,826
60,640
Stockholders' equity:
Preferred stock, $0.0001 par value;
100,000,000 shares authorized at September 30, 2024 and December
31, 2023; no shares issued and outstanding at September 30, 2024
and December 31, 2023
—
—
Common stock, $0.0001 par value;
1,000,000,000 shares authorized at September 30, 2024 and December
31, 2023; 120,222,547 and 116,859,468 shares issued and outstanding
at September 30, 2024 and December 31, 2023, respectively
12
12
Additional paid-in capital
379,999
353,890
Accumulated other comprehensive income
49
50
Accumulated deficit
(88,332
)
(39,367
)
Total stockholders’ equity
291,728
314,585
Total liabilities and stockholders’
equity
$
331,554
$
375,225
OMNIAB, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share
data)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Revenue:
License and milestone revenue
$
1,375
$
2,010
5,216
$
18,986
Service revenue
2,479
3,016
9,416
9,425
Royalty revenue
318
451
955
931
Total revenue
4,172
5,477
15,587
29,342
Operating expenses:
Research and development
13,318
13,867
41,804
41,759
General and administrative
7,079
8,511
23,381
25,444
Amortization of intangibles
3,393
3,398
11,348
10,147
Other operating expense (income), net
146
16
(2,324
)
205
Total operating expenses
23,936
25,792
74,209
77,555
Loss from operations
(19,764
)
(20,315
)
(58,622
)
(48,213
)
Other income (expense), net:
Interest income
691
1,265
2,451
3,874
Other income (expense), net
(8
)
8
(17
)
4
Total other income (expense), net
683
1,273
2,434
3,878
Loss before income taxes
(19,081
)
(19,042
)
(56,188
)
(44,335
)
Income tax benefit
2,708
3,304
7,223
7,769
Net loss
$
(16,373
)
$
(15,738
)
$
(48,965
)
$
(36,566
)
Net loss per share, basic and diluted
$
(0.16
)
$
(0.16
)
$
(0.48
)
$
(0.37
)
Weighted-average shares outstanding, basic
and diluted
102,393
99,905
101,538
99,521
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241112532450/en/
OmniAb, Inc. Neha Singh, Ph. D. investors@OmniAb.com X
@OmniAbTech (510) 768-7760
OmniAb (NASDAQ:OABI)
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