SAN
DIEGO, March 6, 2023 /PRNewswire/ -- Inhibrx,
Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a
biopharmaceutical company with four clinical programs in
development and a strong emerging pipeline, today reported
financial results for the fourth quarter and fiscal year
2022.
Key Highlights
- INBRX-101: Timing for the potentially registration-enabling
trial for Alpha-1 Antitrypsin Deficiency, or AATD, is on track with
sites expected to activate and initiate enrollment in April 2023. Initial trial data is anticipated in
early 2025. We expect to initiate clinical trial(s) in Graft versus
host disease, or GvHD, during the second half of 2023.
- INBRX-105: To date, we have observed a therapeutic window for
our targeted 4-1BB agonist in the checkpoint refractory population,
with responses both as a single agent and in combination with
Keytruda®. We expect to announce clinical data from
these cohorts during the second half of 2023.
- INBRX-109: We believe we can now more precisely identify the
at-risk population for severe liver toxicity in our DR5 agonist
trials as elderly individuals with fatty liver disease. Enrollment
is paused while we implement the Hepatic Steatosis Index, or HSI,
into our screening criteria protocol. We expect enrollment to
resume by the middle of the year and do not anticipate this to
impact the timeline for completion of the potentially
registration-enabling trial in chondrosarcoma during the second
half of 2024.
Financial Results
- Cash and Cash Equivalents. As of
December 31, 2022, Inhibrx had cash
and cash equivalents of $273.9
million, compared to $131.3
million as of December 31,
2021.
- R&D Expense. Research and development
expenses were $30.5 million during
the fourth quarter of 2022, compared to $18.6 million during the fourth quarter of 2021.
Research and development expenses were $110.2 million during the fiscal year 2022,
compared to $71.4 million during the
fiscal year 2021. Clinical trial expenses increased related to the
progression of the Company's four Phase 1 trials and its
potentially registration-enabling Phase 2 trial, which was
initiated during the second quarter of 2021. The Company 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 both periods, partially attributable to
an increase in headcount as the Company continues to expand its
clinical operations and technical operations teams as well as
increased salaries and the expansion of our bonus eligibility pool
in the current year.
- G&A Expense. General and administrative
expenses were $5.3 million during the
fourth quarter of 2022, compared to $3.6
million during the fourth quarter of 2021. General and
administrative expenses were $21.1
million during the fiscal year 2022, compared to
$12.4 million during the fiscal year
2021. This overall increase in both periods was primarily driven by
an increase in personnel-related costs, in part due to the
expansion of the Company's commercial strategy team as well as an
increase in salaries and the expansion of our bonus eligibility
pool in the current year. In addition, market research and other
scientific publication expenses were incurred related to its
continued pre-commercialization efforts for INBRX-101 and
INBRX-109. The Company also incurred increased accounting and legal
fees as a result of the establishment of its ATM facility and the
continued expansion of its intellectual property portfolio.
- Net Loss. Net loss was $40.9 million during the fourth quarter of 2022,
or $0.95 per share, compared to
$21.2 million during the fourth
quarter of 2021, or $0.55 per share.
Net loss was $145.2 million during
the fiscal year 2022, or $3.62 per
share, compared to $81.8 million
during the fiscal year 2021, or $2.15
per share.
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 protein engineering platforms.
Inhibrx has collaborations with 2seventy bio, Inc. (formerly
bluebird bio, Inc.), Bristol-Myers Squibb Company 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; 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)
|
|
|
THREE MONTHS
ENDED
DECEMBER 31,
|
|
YEAR
ENDED DECEMBER 31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
(unaudited)
|
|
|
Revenue:
|
|
|
|
|
|
|
|
License fee
revenue
|
$
274
|
|
$
2,836
|
|
$
2,178
|
|
$
7,125
|
Grant
revenue
|
—
|
|
20
|
|
14
|
|
106
|
Total
revenue
|
274
|
|
2,856
|
|
2,192
|
|
7,231
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
30,451
|
|
18,615
|
|
110,186
|
|
71,440
|
General and
administrative
|
5,323
|
|
3,645
|
|
21,123
|
|
12,355
|
Total operating
expenses
|
35,774
|
|
22,260
|
|
131,309
|
|
83,795
|
Loss from
operations
|
(35,500)
|
|
(19,404)
|
|
(129,117)
|
|
(76,564)
|
Total other income
(expense)
|
(5,416)
|
|
(1,785)
|
|
(16,106)
|
|
(5,202)
|
Provision for income
taxes
|
(1)
|
|
—
|
|
3
|
|
2
|
Net loss
|
$
(40,915)
|
|
$
(21,189)
|
|
$ (145,226)
|
|
$
(81,768)
|
Net loss per share,
basic and diluted
|
$
(0.95)
|
|
$
(0.55)
|
|
$
(3.62)
|
|
$
(2.15)
|
Weighted-average shares
of common stock
outstanding, basic and diluted
|
43,268
|
|
38,581
|
|
40,108
|
|
38,010
|
Inhibrx, Inc.
Condensed Consolidated Balance Sheets (In
thousands)
|
|
|
AS OF DECEMBER
31,
|
|
2022
|
|
2021
|
|
|
|
|
Cash and cash
equivalents
|
$
273,865
|
|
$
131,301
|
Other current
assets
|
6,628
|
|
7,811
|
Non-current
assets
|
10,382
|
|
11,338
|
Total
assets
|
$
290,875
|
|
$
150,450
|
|
|
|
|
Debt, current and
non-current
|
$
202,069
|
|
$
70,470
|
Other current
liabilities
|
27,576
|
|
22,454
|
Other non-current
liabilities
|
3,173
|
|
5,143
|
Total
liabilities
|
232,818
|
|
98,067
|
Stockholders'
equity
|
58,057
|
|
52,383
|
Total liabilities and
stockholders' equity
|
$
290,875
|
|
$
150,450
|
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SOURCE Inhibrx Inc.