SAN
DIEGO, Nov. 9, 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 third
quarter of 2023 and provided an update on recent corporate
highlights.
Recent Corporate Highlights
- On August 29, 2023, Inhibrx
announced that it had entered into a securities purchase agreement,
or the Purchase Agreement, for a private placement financing, or
the PIPE, resulting in gross proceeds of approximately $200.0 million. Pursuant to the Purchase
Agreement, the Company sold and issued to certain institutional and
other accredited investors, or the Purchasers, 3,621,314 shares of
its common stock at a purchase price of $19.35 per share and, with respect to certain
Purchasers, pre-funded warrants to purchase 6,714,636 shares of its
common stock at a purchase price of $19.3499 per pre-funded warrant, which have an
exercise price of $0.0001 per
share.
- On September 19,
2023, Inhibrx announced that it had retained full global
rights to INBRX-101 as a result of Chiesi Farmaceutici S.p.A
declining to exercise its option for the ex-North American rights
to develop and commercialize INBRX-101 for the treatment of
patients with emphysema due to Alpha-1 Antitrypsin Deficiency, or
AATD.
- On November 2, 2023, Inhibrx
announced preliminary efficacy and safety data at the Annual
Connective Tissue Oncology Society (CTOS) Conference from the Phase
1 trial of INBRX-109 in combination with Irinotecan (IRI) and
Temozolomide (TMZ) for the treatment of advanced or metastic,
unresectable Ewing sarcoma. Among the 13 patients evaluable as of
the data cut of September 8, 2023,
the observed disease control rate was 76.9%, or 10 out of 13
patients as measured by RECISTv1.1, with 7 patients achieving
partial responses (53.8%) and 3 patients achieving stable disease
(23.1%). Durable clinical benefit was observed in 4 patients
(30.8%) who achieved disease control lasting greater than 6 months.
Overall, INBRX-109 in combination with IRI/TMZ was well tolerated.
The most common adverse events were diarrhea, nausea and fatigue,
all consistent with the known safety profile of IRI/TMZ.
Financial Results
- Cash and Cash Equivalents. As of
September 30, 2023, Inhibrx had cash and cash equivalents of
$337.3 million, compared to
$192.5 million at June 30, 2023. During the third quarter of 2023,
the Company received gross proceeds of $200.0 million from the PIPE. These proceeds were
offset in part by cash outflows from operations, which increased
during the third quarter of 2023 primarily due to the following
activity:
- a large upfront payment made to one of the Company's contract
development and manufacturing organizations, or CDMOs, for the
prepayment of raw materials for future manufacturing runs, as well
as other increased development and manufacturing costs to support
its clinical candidates; and
- the Company's payments to its contract research organizations,
or CRO, partners continue to increase as the
registration-enabling Phase 2 trials progress for both INBRX-101
for the treatment of emphysema due to AATD and INBRX-109 for the
treatment of unresectable or metastatic conventional
chondrosarcoma, and additional cash outlay to its CRO partners for
the INBRX-105 and INBRX-106 Phase 1/2 trials.
- R&D Expense. Research and development
expenses were $38.1 million during
the third quarter of 2023, compared to $24.9
million during the third quarter of 2022. The increase in
research and development expenses was primarily due to the
following factors:
- an increase in clinical trial expenses, primarily related to
the registration-enabling Phase 2 trial for INBRX-101 for the
treatment of emphysema due to AATD, which was initiated during
the current year, as well as the progression of its INBRX-109
registration-enabling Phase 2 trial for the treatment of
unresectable or metastatic conventional chondrosarcoma;
- an increase in CMC expenses due to the nature of the
development and manufacturing activities performed at its CDMO and
CRO partners supporting the Company's clinical and preclinical
therapeutic candidates, which reflect the stage-specific needs of
its programs during each period, including early and late stage
drug substance clinical manufacturing, drug product manufacturing,
and selected biologics license applications-enabling activities;
and
- an increase in personnel-related costs, partially attributable
to an increase in headcount as the Company continues to expand its
clinical teams, as well as the issuance of additional stock options
and the expansion of the Company's bonus eligibility pool in the
current year.
- G&A Expense. General and administrative
expenses were $7.9 million during the
third quarter of 2023, compared to $5.3
million during the third quarter of 2022. The increase in
general and administrative expenses was primarily due to the
following factors:
- 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 its bonus eligibility pool in the current
year;
- an increase in consulting services supporting the Company's
commercial operations business intelligence strategies, as well as
market research and other scientific publication expenses incurred
related to the Company's continued pre-commercialization efforts
for INBRX-101 and INBRX-109; and
- an increase in professional service expenses related to
accounting and legal services which support the Company in its
general corporate and intellectual property matters.
- Net Loss. Net loss was $51.8 million during the third quarter of 2023,
or $1.10 per share, compared to
$35.3 million during the third
quarter of 2022, or $0.90 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.
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 or
implication that the results of earlier clinical trials or studies
will be representative of later clinical trials. 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
ir@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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue:
|
|
|
|
|
|
|
|
License fee
revenue
|
$
119
|
|
$
278
|
|
$
166
|
|
$
1,904
|
Grant
revenue
|
—
|
|
—
|
|
—
|
|
14
|
Total
revenue
|
119
|
|
278
|
|
166
|
|
1,918
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
38,057
|
|
24,934
|
|
109,549
|
|
79,735
|
General and
administrative
|
7,889
|
|
5,347
|
|
21,549
|
|
15,800
|
Total operating
expenses
|
45,946
|
|
30,281
|
|
131,098
|
|
95,535
|
Loss from
operations
|
(45,827)
|
|
(30,003)
|
|
(130,932)
|
|
(93,617)
|
Total other income
(expense)
|
(5,960)
|
|
(5,322)
|
|
(16,818)
|
|
(10,690)
|
Provision for income
taxes
|
2
|
|
—
|
|
7
|
|
4
|
Net loss
|
$
(51,789)
|
|
$
(35,325)
|
|
$
(147,757)
|
|
$
(104,311)
|
Net loss per share,
basic and diluted
|
$
(1.10)
|
|
$
(0.90)
|
|
$
(3.30)
|
|
$
(2.67)
|
Weighted-average shares
of common stock and
pre-funded warrants
outstanding, basic and diluted
|
47,151
|
|
39,071
|
|
44,803
|
|
39,043
|
Inhibrx, Inc.
Condensed Consolidated Balance Sheets
(In
thousands)
(Unaudited)
|
|
|
SEPTEMBER
30,
|
|
DECEMBER
31,
|
|
2023
|
|
2022
|
|
|
|
|
Cash and cash
equivalents
|
$
337,327
|
|
$
273,865
|
Other current
assets
|
25,970
|
|
6,628
|
Non-current
assets
|
9,436
|
|
10,382
|
Total
assets
|
$
372,733
|
|
$
290,875
|
|
|
|
|
Debt, current and
non-current
|
$
205,721
|
|
$
202,069
|
Other current
liabilities
|
35,771
|
|
27,576
|
Other non-current
liabilities
|
1,646
|
|
3,173
|
Total
liabilities
|
243,138
|
|
232,818
|
Stockholders'
equity
|
129,595
|
|
58,057
|
Total liabilities and
stockholders' equity
|
$
372,733
|
|
$
290,875
|
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SOURCE Inhibrx, Inc.