SAN
DIEGO, Nov. 7, 2022 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a biopharmaceutical company with four clinical
programs in development and a strong emerging pipeline, today
reported financial results for the third quarter of 2022 and
provided an update on recent corporate highlights.
Recent Corporate Highlights
- On August 15, 2022, Inhibrx
announced that the European Commission, based on a positive opinion
issued by the European Medicines Agency, has granted orphan
medicinal product designation to INBRX-109 for the treatment of
chondrosarcoma.
- On October 4, 2022, Inhibrx
announced that, based on discussions with the U.S. Food and Drug
Administration (FDA), there is potential to pursue an accelerated
approval in the United States for
INBRX-101 in patients with emphysema due to Alpha-1 Antitrypsin
Deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum
levels as the surrogate endpoint. Inhibrx plans to initiate in the
first quarter of 2023 a potential registration-enabling clinical
trial using functional AAT as a surrogate endpoint with the intent
to submit for regulatory approval under the FDA's Accelerated
Approval Program.
- On October 4, 2022, Inhibrx
announced the detection of INBRX-101 in the bronchoalveolar lavage
fluid samples from all AATD patients tested in the Phase 1
study.
- On October 26, 2022, Inhibrx
announced the draw of its final tranche under its loan and security
agreement with Oxford Finance LLC and received gross proceeds of
$30.0 million.
Financial Results
- Cash and Cash Equivalents. As of
September 30, 2022, Inhibrx had cash
and cash equivalents of $146.1
million, compared to $131.3
million as of December 31,
2021. As of October 31, 2022,
Inhibrx had cash and cash equivalents of $290.2 million.
- R&D Expense. Research and development
expenses were $24.9 million during
the third quarter of 2022, compared to $18.5
million during the third quarter of 2021. During the third
quarter of 2022, Inhibrx's clinical trial expenses increased, both
for its Phase 1 trials as they continue to progress, as well as its
continued expenses related to the INBRX-109 potentially
registration-enabling Phase 2 trial which was initiated during the
second quarter of 2021. The organization also incurred increased
contract manufacturing expenses due to greater production run costs
at its contract development and manufacturing organization
partners, including drug substance batch manufacturing in
preparation for a Phase 2 trial supply and pilot batch production
for one of its preclinical candidates. Personnel-related costs also
increased during the period, which is attributable to an increase
in headcount as Inhibrx continues to expand its clinical operations
and technical operations teams.
- G&A Expense. General and administrative
expenses were $5.3 million during the
third quarter of 2022, compared to $2.8
million during the third quarter of 2021. This overall
increase was primarily driven by an increase in additional
personnel-related costs due to an increase in headcount as the
organization builds out its commercial strategy team. In addition,
Inhibrx incurred market research and other scientific publication
expenses related to its continued pre-commercialization efforts for
INBRX-101 and INBRX-109.
- Net Loss. Net loss was $35.3 million during the third quarter of 2022,
or $0.90 per share, compared to
$20.6 million during the third
quarter of 2021, or $0.54 per
share.
About the Inhibrx sdAb Platform
Inhibrx utilizes
diverse methods of protein engineering in the construction of
therapeutic candidates that can address the specific requirements
of complex target and disease biology. A key tool for this effort
is the Inhibrx proprietary single-domain antibody (sdAb) platform,
which enables the development of therapeutic candidates with
attributes superior to other monoclonal antibody and fusion protein
approaches. This platform allows the combination of multiple
binding units in a single molecule, enabling the creation of
therapeutic candidates with defined valency or multiple
specificities that can achieve enhanced cell signaling or
conditional activation. An additional benefit of this platform is
that these optimized, multi-functional entities can be manufactured
using the established processes that are commonly used to produce
therapeutic proteins.
About Inhibrx, Inc.
Inhibrx is a clinical-stage
biopharmaceutical company focused on developing a broad pipeline of
novel biologic therapeutic candidates in oncology and orphan
diseases. Inhibrx utilizes diverse methods of protein engineering
to address the specific requirements of complex target and disease
biology, including its proprietary sdAb platform. Inhibrx has
collaborations with 2seventy bio (formerly bluebird bio),
Bristol-Myers Squibb and Chiesi Farmaceutici S.p.A. For more
information, please visit www.inhibrx.com.
Forward Looking Statements
Inhibrx cautions you that
statements contained in this press release regarding matters that
are not historical facts are forward-looking statements. These
statements are based on Inhibrx's current beliefs and expectations.
These forward-looking statements include, but are not limited to,
statements regarding: Inhibrx's and its investigators' judgments
and beliefs regarding the strength of Inhibrx's pipeline and the
observed safety and efficacy to date of its therapeutic candidates;
future clinical development of Inhibrx's therapeutic candidates,
including any potential for accelerated approval. Actual results
may differ from those set forth in this press release due to the
risks and uncertainties inherent in Inhibrx's business, including,
without limitation, risks and uncertainties regarding: the
initiation, timing, progress and results of its preclinical studies
and clinical trials, and its research and development programs; its
ability to advance therapeutic candidates into, and successfully
complete, clinical trials; its interpretation of preclinical data
and initial, interim or preliminary data from its clinical trials,
including interpretations regarding disease control and disease
response; the timing or likelihood of regulatory filings and
approvals; the successful commercialization of its therapeutic
candidates, if approved; the pricing, coverage and reimbursement of
its therapeutic candidates, if approved; its ability to utilize its
technology platform to generate and advance additional therapeutic
candidates; the implementation of its business model and strategic
plans for its business and therapeutic candidates; its ability to
successfully manufacture therapeutic candidates for clinical trials
and commercial use, if approved; its ability to contract with
third-party suppliers and manufacturers and their ability to
perform adequately; the scope of protection it is able to establish
and maintain for intellectual property rights covering its
therapeutic candidates; its ability to enter into strategic
partnerships and the potential benefits of these partnerships; its
estimates regarding expenses, capital requirements and needs for
additional financing and financial performance; its expectations
regarding the impact of the COVID-19 pandemic on its business; and
other risks described from time to time in the "Risk Factors"
section of its filings with the U.S. Securities and Exchange
Commission, including those described in its Annual Report on Form
10-K as well as its Quarterly Reports on Form 10-Q, and
supplemented from time to time by its Current Reports on Form 8-K.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and Inhibrx undertakes no obligation to update these 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.
Investor and Media Contact:
Kelly D. Deck
Chief Financial Officer
kelly@inhibrx.com
858-795-4260
Inhibrx, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(unaudited)
|
|
|
|
THREE MONTHS
ENDED
SEPTEMBER
30,
|
|
NINE MONTHS
ENDED
SEPTEMBER 30,
|
|
|
2022
|
|
2021
|
|
2021
|
|
2020
|
Revenue:
|
|
|
|
|
|
|
|
|
License fee
revenue
|
|
$
278
|
|
$
2,508
|
|
$
1,904
|
|
$
4,289
|
Grant
revenue
|
|
—
|
|
24
|
|
14
|
|
86
|
Total
revenue
|
|
278
|
|
2,532
|
|
1,918
|
|
4,375
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
24,934
|
|
18,485
|
|
79,735
|
|
52,825
|
General and
administrative
|
|
5,347
|
|
2,848
|
|
15,800
|
|
8,710
|
Total operating
expenses
|
|
30,281
|
|
21,333
|
|
95,535
|
|
61,535
|
Loss from
operations
|
|
(30,003)
|
|
(18,801)
|
|
(93,617)
|
|
(57,160)
|
Total other income
(expense)
|
|
(5,322)
|
|
(1,779)
|
|
(10,690)
|
|
(3,417)
|
Provision for income
taxes
|
|
—
|
|
—
|
|
4
|
|
2
|
Net loss
|
|
$
(35,325)
|
|
$
(20,580)
|
|
$
(104,311)
|
|
$
(60,579)
|
Net loss per share,
basic and diluted
|
|
$
(0.90)
|
|
$
(0.54)
|
|
$
(2.67)
|
|
$
(1.60)
|
Weighted-average shares
of common stock
outstanding, basic and diluted
|
|
39,071
|
|
37,893
|
|
39,043
|
|
37,818
|
Inhibrx, Inc.
Condensed Consolidated Balance Sheets
(In
thousands)
|
|
|
|
SEPTEMBER
30,
|
|
DECEMBER
31,
|
|
|
2022
|
|
2021
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
146,073
|
|
$
131,301
|
Other current
assets
|
|
7,681
|
|
7,811
|
Non-current
assets
|
|
11,098
|
|
11,338
|
Total
assets
|
|
$
164,852
|
|
$
150,450
|
|
|
|
|
|
Debt, current and
non-current
|
|
$
170,819
|
|
$
70,470
|
Other current
liabilities
|
|
25,426
|
|
22,454
|
Other non-current
liabilities
|
|
3,657
|
|
5,143
|
Total
liabilities
|
|
199,902
|
|
98,067
|
Stockholders'
equity
|
|
(35,050)
|
|
52,383
|
Total liabilities and
stockholders' equity
|
|
$
164,852
|
|
$
150,450
|
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SOURCE Inhibrx Inc.