Conference Call with Slides Begins at 4:30
p.m. Eastern Time Today
OmniAb, Inc. (NASDAQ: OABI) today reported financial
results for the three months ended March 31, 2024, and provided
operating and partner program updates.
“The OmniAb team continued to make great progress this past
quarter in advancing and expanding our portfolio and partnership
base. We added three new platform license agreements in the first
quarter, bringing our total active partners to 80, net of
attrition,” said Matt Foehr, Chief Executive Officer of OmniAb. “We
have built our company upon a differentiated suite of technologies
and a highly scalable and leverageable business model, and our
growth during the past 18 months reflects the strength of our
offering to the industry. We’re off to a strong start in 2024 and
we look forward to continued progress by our partners and expansion
of our technology as the year progresses.”
First Quarter 2024 Financial Results
Revenue for the first quarter of 2024 was $3.8 million, compared
with $16.9 million for the same period in 2023, with the decrease
primarily due to the recognition in the 2023 period of a $10
million milestone related to the first commercial sale of TECVAYLI®
(teclistamab) in the EU and lower service revenue in the 2024
period as a result of the completion of discovery work on certain
ion channel programs.
Research and development expense was $14.6 million for the first
quarter of 2024, compared with $13.8 million for the same period in
2023, with the increase primarily due to higher personnel costs.
General and administrative expense was $8.3 million for the first
quarter of 2024, compared with $8.2 million for the same period in
2023.
Net loss for the first quarter of 2024 was $19.0 million, or
$0.19 per share, compared with a net loss of $6.1 million, or $0.06
per share, for the same period in 2023.
As of March 31, 2024, OmniAb had cash, cash equivalents and
short-term investments of $69.0 million.
2024 Financial Guidance
OmniAb continues to expect operating expense in 2024 to be
approximately the same as in 2023, as the Company is now staffed
and resourced to leverage the future growth of the business.
OmniAb continues to expect its cash use in 2024 to be relatively
similar to its cash use in 2023, excluding the $35 million TECVAYLI
milestone payment received in 2023. Given the expected progression
of the existing partnered pipeline, OmniAb expects its cash use in
2025 to be substantially lower than in 2024. OmniAb’s current cash
balance and cash from operations are expected to provide sufficient
capital to fund operations for the foreseeable future.
First Quarter 2024 and Recent Business Highlights
During the first quarter of 2024, OmniAb signed three new
license agreements including ImmunoBiochem Corporation, the
University of Georgia and a stealth Boston-based venture-backed
start-up. As of March 31, 2024, the Company had 80 active partners
and 327 active programs, including 31 OmniAb-derived programs in
clinical development or being commercialized.
First quarter 2024 and recent partner highlights include the
following:
Batoclimab
- Immunovant reported that global Phase 3 clinical trials of
batoclimab (anti-FcRn) in myasthenia gravis (MG) and thyroid eye
disease (TED) are progressing and are on track for topline data
readout in the second half of 2024 (MG) and the first half of 2025
(TED). Initial period 1 data from the Phase 2b clinical trial in
chronic inflammatory demyelinating polyneuropathy are expected in
the second or third quarter of 2024.
- HanAll Biopharma announced that in collaboration with
Immunovant, the Phase 3 clinical study is progressing in
generalized myasthenia gravis in Japan. HanAll also reported that a
clinical trial notification was approved to initiate a Phase 3
clinical study of batoclimab in TED in Japan.
IMVT-1402
- Immunovant announced plans to initiate four to five potential
registrational programs for IMVT-1402 (second-generation anti-FcRn)
during its fiscal year ending March 31, 2025. The company also
plans on initiating trials in 10 indications for IMVT-1402 over its
next two fiscal years.
- Immunovant announced that the United States Patent and
Trademark Office has issued U.S. Patent No. 11,926,669 (“the ‘669
patent”) for IMVT-1402. The allowed claims cover composition of
matter for the binding sequence of IMVT-1402 to FcRn, method of use
of the antibody for treating autoimmune disease, as well as methods
for its manufacturing. Not including any potential patent term
extension, the ‘669 patent will expire on June 23, 2043.
M9140
- At the American Association for Cancer Research Annual Meeting,
Merck KGaA presented data on M9140, a novel antibody-drug conjugate
with topoisomerase 1 inhibitor payload targeting carcinoembryonic
antigen-related cell adhesion molecule 5 (CEACAM5) expressing
tumors. M9140 demonstrated high potency, strong antitumor activity
and bystander effect in preclinical models.
- A first-in-human Phase 1 study to evaluate the safety,
tolerability, pharmacokinetics and preliminary clinical activity of
M9140 in patients with advanced solid tumors is ongoing.
Acasunlimab
- Genmab expects to announce acasunlimab (GEN1046: PD-L1 x 4-1BB)
Phase 2 data in second-line non-small cell lung cancer (NSCLC) in
the first half of 2024.
- A poster titled “Acasunlimab (duobody-PD-L1x4-1BB) alone or in
combination with pembrolizumab in patients with previously treated
metastatic non-small cell lung cancer: Initial results of a
randomized, open-label, Phase 2 trial” will be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting 2024 at
9:00 a.m. Central time on Saturday, June 1, 2024.
- In addition, Genmab plans to initiate a Phase 3 study of
acasunlimab in second-line NSCLC in 2024.
Sugemalimab
- CStone announced the National Medical Products Administration
of China has approved the supplemental biologics application for
sugemalimab (Cejemly®) in combination with fluorouracil and
platinum-based chemotherapy as first-line treatment of unresectable
locally advanced, recurrent or metastatic gastric or
gastroesophageal junction adenocarcinoma with a PD-L1 expression
(Combined Positive Score [CPS] ≥5). Sugemalimab is the first PD-L1
monoclonal antibody approved for this indication.
- CStone also announced that the results of the progression-free
survival final analysis and the overall survival interim analysis
in the registrational GEMSTONE-304 study for unresectable locally
advanced, recurrent or metastatic esophageal squamous cell
carcinoma were published in Nature Medicine.
OmniAb scientists published a peer-reviewed paper in the Journal
of Immunology demonstrating that chickens can be genetically
engineered to produce functional single-domain antibodies (sdAbs).
This modality, produced naturally by camelids, has gained
popularity as a small, robust and highly versatile building block
for antibody discovery, especially in constructing multi-specifics
and CAR-T cells. These data supported the feasibility of the
Company’s next-generation transgenic chicken OmnidAb™ that produces
fully human stabilized sdAbs. The OmnidAb platform was launched
during the fourth quarter of 2023.
OmniAb will highlight some of its high-throughput single cell
screening xPloration™ data at the 20th Annual PEGS Boston
Conference and Expo, where Bob Chen, Ph.D., Senior Director,
Discovery Systems, will give a presentation titled “Deep Screening
in Harmony with Artificial Intelligence for Bispecific Antibody
Discovery” at 12:20 p.m. Eastern time on Wednesday, May 15,
2024.
The Company also expects that multiple partners will be
presenting data from programs developed with OmniAb technology at
the ASCO Annual Meeting taking place May 31 - June 4, 2024.
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 08922. 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 industry 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 something 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 ability to scale and leverage our business
model; the growth prospects of our business; 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; the sufficiency of
our staffing and resources; expected operating expense and 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 BALANCE
SHEETS
(in thousands, except share and
per share data)
March 31, 2024
December 31, 2023
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
19,060
$
16,358
Short-term investments
49,947
70,625
Accounts receivable, net
4,045
3,844
Prepaid expenses and other current
assets
3,665
4,074
Total current assets
76,717
94,901
Intangible assets, net
152,055
155,467
Goodwill
83,979
83,979
Property and equipment, net
17,957
18,249
Operating lease right-of-use assets
19,362
19,884
Restricted cash
560
560
Other long-term assets
1,926
2,185
Total assets
$
352,556
$
375,225
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
3,556
$
4,411
Accrued expenses and other current
liabilities
4,027
7,068
Current contingent liabilities
891
1,303
Current deferred revenue
5,530
6,848
Current operating lease liabilities
3,516
3,486
Total current liabilities
17,520
23,116
Long-term contingent liabilities
3,178
3,203
Deferred income taxes, net
8,737
11,354
Long-term operating lease liabilities
21,418
22,075
Long-term deferred revenue
279
862
Other long-term liabilities
31
30
Total liabilities
51,163
60,640
Stockholders' equity:
Preferred stock, $0.0001 par value;
100,000,000 shares authorized at March 31, 2024 and December 31,
2023; no shares issued and outstanding at March 31, 2024 and
December 31, 2023
—
—
Common stock, $0.0001 par value;
1,000,000,000 shares authorized at March 31, 2024 and December 31,
2023; 117,388,789 and 116,859,468 shares issued and outstanding at
March 31, 2024 and December 31, 2023, respectively
12
12
Additional paid-in capital
359,726
353,890
Accumulated other comprehensive (loss)
income
(17
)
50
Accumulated deficit
(58,328
)
(39,367
)
Total stockholders’ equity
301,393
314,585
Total liabilities and stockholders’
equity
$
352,556
$
375,225
OMNIAB, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share
data)
Three Months Ended March
31,
2024
2023
Revenues:
License and milestone revenue
$
716
$
12,646
Service revenue
2,766
3,958
Royalty revenue
319
315
Total revenues
3,801
16,919
Operating expenses:
Research and development
14,551
13,759
General and administrative
8,337
8,195
Amortization of intangibles
3,412
3,369
Other operating expense, net
54
49
Total operating expenses
26,354
25,372
Loss from operations
(22,553
)
(8,453
)
Other income:
Interest income
975
1,324
Total other income, net
975
1,324
Loss before income taxes
(21,578
)
(7,129
)
Income tax benefit
2,617
1,029
Net loss
$
(18,961
)
$
(6,100
)
Net loss per share, basic and diluted
$
(0.19
)
$
(0.06
)
Weighted-average shares outstanding, basic
and diluted
100,755
99,158
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OmniAb, Inc. Neha Singh, Ph.D. investors@OmniAb.com Twitter
@OmniAbTech (510) 768-7760
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