SAN
DIEGO, Aug. 7, 2023 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), or Inhibrx, or the Company, a biopharmaceutical
company with four programs in ongoing clinical trials and a strong
emerging pipeline, today reported financial results for the second
quarter of 2023 and provided an update on recent corporate
highlights.
Recent Corporate Highlights
- On May 30, 2023, Inhibrx
announced that the U.S. Food and Drug Administration granted Fast
Track designation to INBRX-101, an optimized recombinant human
AAT-Fc fusion protein, for the treatment of patients with emphysema
due to alpha-1 antitrypsin deficiency, or AATD.
- On July 24, 2023, Inhibrx
received written scientific advice from the European Medicines
Agency, or EMA, which confirmed CT lung densitometry as the
established primary regulatory endpoint to support a marketing
authorization application in the European Union for the treatment
of emphysema secondary to AATD. Inhibrx's delivery of the EMA
scientific advice to Chiesi Farmaceutici S.p.A, or Chiesi,
triggered Chiesi's 60-day option period window to obtain an
exclusive license to develop and commercialize INBRX-101 outside of
the United States and Canada.
Financial Results
- Cash and Cash Equivalents. As of
June 30, 2023, Inhibrx had cash and cash equivalents of
$192.5 million, compared to
$273.9 million as of
December 31, 2022. The increase in cash outflow during the
second quarter of 2023 was a result of the timing of payments made
to the Company's contract development and manufacturing
organizations, or CDMOs, related to development and manufacturing
costs supporting our clinical and preclinical candidates.
Additionally, there was an increase in cash outflow during the
period upon the initiation of the INBRX-101 registration-enabling
trial to the Company's contract research organization, or CRO,
partner, as well as the timing of payments associated with the
progression of its INBRX-109 Phase 1 combination cohorts and
registration-enabling Phase 2 trial for the treatment of
unresectable or metastatic conventional chondrosarcoma.
- R&D Expense. Research and development
expenses were $34.1 million during
the second quarter of 2023, compared to $29.9 million during the second quarter of 2022.
During the second quarter of 2023, Inhibrx's clinical trial
expenses increased, primarily related to the initiation of the
registration-enabling Phase 2 trial for INBRX-101 for the treatment
of emphysema due to AATD, as well as the progression of our
INBRX-109 registration-enabling Phase 2 trial for the treatment of
unresectable or metastatic conventional chondrosarcoma.
Personnel-related costs also increased during both periods,
partially attributable to an increase in headcount as the Company
continues to expand its clinical operations teams, as well as the
issuance of additional stock options and the expansion of our bonus
eligibility pool in the current year. These increases were offset
in part by decreased CMC expenses incurred at our CDMO and CRO
partners supporting our clinical and preclinical therapeutic
candidates due to the nature of the development and manufacturing
activities performed, which reflect the stage-specific needs of our
programs during each period.
- G&A Expense. General and administrative
expenses were $7.3 million during the
second quarter of 2023, compared to $5.4
million during the second quarter of 2022. This overall
increase was primarily driven by an increase in additional
personnel-related costs in part due to the expansion of the
Company's commercial strategy and medical affairs team as well as
the issuance of additional stock options 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.
- Net Loss. Net loss was $47.1 million during the second quarter of 2023,
or $1.08 per share, compared to
$37.7 million during the second
quarter of 2022, or $0.97 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. 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;
whether a trial is registration-enabling; future clinical
development of Inhibrx's therapeutic candidates, including any
potential for approval or 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)
(Unaudited)
|
|
|
THREE MONTHS
ENDED JUNE
30,
|
|
SIX MONTHS
ENDED JUNE
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue:
|
|
|
|
|
|
|
|
License fee
revenue
|
$
30
|
|
$
711
|
|
$
47
|
|
$
1,626
|
Grant
revenue
|
—
|
|
—
|
|
—
|
|
14
|
Total
revenue
|
30
|
|
711
|
|
47
|
|
1,640
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
34,106
|
|
29,906
|
|
71,492
|
|
54,801
|
General and
administrative
|
7,263
|
|
5,402
|
|
13,660
|
|
10,453
|
Total operating
expenses
|
41,369
|
|
35,308
|
|
85,152
|
|
65,254
|
Loss from
operations
|
(41,339)
|
|
(34,597)
|
|
(85,105)
|
|
(63,614)
|
Total other income
(expense)
|
(5,708)
|
|
(3,131)
|
|
(10,858)
|
|
(5,368)
|
Provision for income
taxes
|
5
|
|
4
|
|
5
|
|
4
|
Net loss
|
$
(47,052)
|
|
$
(37,732)
|
|
$
(95,968)
|
|
$
(68,986)
|
Net loss per share,
basic and diluted
|
$
(1.08)
|
|
$
(0.97)
|
|
$
(2.20)
|
|
$
(1.77)
|
Weighted-average shares
of common
stock outstanding, basic and diluted
|
43,642
|
|
39,040
|
|
43,609
|
|
39,029
|
Inhibrx,
Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
|
|
|
JUNE
30,
|
|
DECEMBER
31,
|
|
2023
|
|
2022
|
|
|
|
|
Cash and cash
equivalents
|
$
192,492
|
|
$
273,865
|
Other current
assets
|
10,829
|
|
6,628
|
Non-current
assets
|
9,849
|
|
10,382
|
Total
assets
|
$
213,170
|
|
$
290,875
|
|
|
|
|
Debt, current and
non-current
|
$
204,482
|
|
$
202,069
|
Other current
liabilities
|
31,329
|
|
27,576
|
Other non-current
liabilities
|
2,171
|
|
3,173
|
Total
liabilities
|
237,982
|
|
232,818
|
Stockholders' equity
(deficit)
|
(24,812)
|
|
58,057
|
Total liabilities and
stockholders' equity (deficit)
|
$
213,170
|
|
$
290,875
|
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SOURCE Inhibrx Inc.