-First patient dosed with EGFR-TRACTr (JANX008)
in first-in-human Phase 1 clinical trial in patients with solid
tumors- -Interim clinical update from Phase 1 trial of JANX007
expected in 2H 2023- -$316.9 million in cash and cash equivalents
and short-term investments at end of first quarter 2023-
Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a
clinical-stage biopharmaceutical company developing a broad
pipeline of novel immunotherapies by applying its proprietary
technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor
Activated Immunomodulator (TRACIr) platforms, today reported
financial results for the first quarter ended March 31, 2023 and
provided a business update.
“Janux hit a major milestone in the first quarter as we brought
our second TRACTr program into a first-in-human clinical trial. We
are excited for the potential for this EGFR-TRACTr to demonstrate
the power of our technology and thereby address critical and urgent
unmet needs for patients with advanced or metastatic solid tumors,”
said David Campbell, Ph.D., President and CEO of Janux.
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
Janux has prioritized its programs to enable sufficient funding
to provide key clinical data assessments for its lead PSMA-TRACTr
and EGFR-TRACTr programs.
- PSMA-TRACTr (JANX007) continues to enroll in first-in-human
Phase 1 clinical trial in mCRPC.
- First patient dosed with EGFR-TRACTr program (JANX008) in
first-in-human Phase 1 clinical trial in patients with solid
tumors.
- PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission
in 2023.
- TROP2-TRACTr evaluations to support development candidate
selection are ongoing.
Janux anticipates providing an interim clinical update from the
PSMA-TRACTr (JANX007) trial in the second half of 2023. In
addition, Janux expects to select a development candidate for its
TROP2-TRACTr in 2023.
FIRST QUARTER 2023 FINANCIAL HIGHLIGHTS:
- Cash and cash equivalents and short-term investments: As
of March 31, 2023, Janux reported cash and cash equivalents and
short-term investments of $316.9 million compared to $327.0 million
at December 31, 2022.
- Research and development expenses: Research and
development expenses for the quarter ended March 31, 2023 were
$15.9 million compared to $10.2 million for the comparable period
in 2022.
- General and administrative expenses: General and
administrative expenses for the quarter ended March 31, 2023 were
$6.5 million compared to $4.9 million for the comparable period in
2022.
- Net loss: For the quarter ended March 31, 2023, Janux
reported a net loss of $17.5 million compared to a net loss of
$13.4 million for the comparable period in 2022.
Janux’s TRACTr and TRACIr Pipeline
JANX008 is a TRACTr that targets epidermal growth factor
receptor (EGFR) and is being studied in a Phase 1 clinical trial
for the treatment of multiple solid cancers including colorectal
cancer, squamous cell carcinoma of the head and neck, non-small
cell lung cancer, and renal cell carcinoma. Janux’s first clinical
candidate, JANX007, is a TRACTr that targets prostate-specific
membrane antigen (PSMA) and is being investigated in a Phase 1
clinical trial in adult subjects with metastatic
castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug
candidate, JANX009, is designed for targeting both the programmed
death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28
receptor on T cells and is being investigated in preclinical
studies for the treatment of solid tumors. Janux is also applying
its proprietary technology to develop a TRACTr designed to target
trophoblast cell surface antigen 2 (TROP2), a clinically validated
anti-tumor target that is overexpressed in various cancer types,
such as breast, lung, urothelial, endometrial, ovarian, prostate,
pancreatic, gastric, colon, head and neck, and glioma. In addition
to named programs, Janux is generating a number of unnamed TRACTr
and TRACIr programs for potential future development.
About Janux Therapeutics
Janux is a clinical-stage biopharmaceutical company developing
next-generation bispecific immunotherapies with the goal of
fighting cancers by killing tumor cells while allowing healthy
tissues to remain unharmed. Janux’s proprietary platforms develop
unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated
Immunomodulators (TRACIr) and support the building of a broad
pipeline of drugs designed to direct and guide the patient’s immune
system to eradicate tumors while minimizing safety concerns. The
company's innovative technology currently focuses on the
engineering of bispecific antibodies functional only in the tumor,
designed to provide safety advantages compared to earlier
generations of bispecific immunotherapies. Currently, Janux’s two
lead TRACTr compounds for PSMA and EGFR are in the clinic. For more
information, please visit www.januxrx.com and follow us on
LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, Janux’s ability to bring new
treatments to cancer patients in need, expectations regarding the
timing, scope and results of Janux’s development activities,
including its ongoing and planned clinical trials, the timing of
and plans for regulatory filings, the potential benefits of Janux’s
product candidates and platform technologies, expectations
regarding the use of Janux’s platform technologies to generate
novel product candidates, the expected timing for announcing
interim clinical updates and the strength of Janux’s balance sheet
and the adequacy of cash on hand. Factors that may cause actual
results to differ materially include the risk that compounds that
appear promising in early research do not demonstrate safety and/or
efficacy in later preclinical studies or clinical trials, the risk
that Janux may not obtain approval to market its product
candidates, uncertainties associated with performing clinical
trials, regulatory filings and applications, risks associated with
reliance on third parties to successfully conduct clinical trials,
the risks associated with reliance on outside financing to meet
capital requirements, and other risks associated with the process
of discovering, developing and commercializing drugs that are safe
and effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. You are urged to consider
statements that include the words “may,” “will,” “would,” “could,”
“should,” “believes,” “estimates,” “projects,” “promise,”
“potential,” “expects,” “plans,” “anticipates,” “intends,”
“continues,” “designed,” “goal,” or the negative of those words or
other comparable words to be uncertain and forward-looking. For a
further list and description of the risks and uncertainties Janux
faces, please refer to Janux’s periodic and other filings with the
Securities and Exchange Commission, which are available at
www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and Janux assumes no obligation to update
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Janux Therapeutics,
Inc.
Condensed Balance
Sheets
(in thousands)
March 31, 2023
December 31, 2022
Assets
(unaudited)
Current assets:
Cash and cash equivalents
$
30,355
$
51,426
Accounts receivable
750
—
Short-term investments
286,520
275,590
Prepaid expenses and other current
assets
3,774
5,423
Total current assets
321,399
332,439
Restricted cash
816
816
Property and equipment, net
7,203
7,086
Operating lease right-of-use assets
21,927
22,279
Other long-term assets
1,611
1,390
Total assets
$
352,956
$
364,010
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
2,051
$
2,159
Accrued liabilities
7,737
8,010
Current portion of deferred revenue
4,935
5,406
Unvested stock liabilities
35
169
Current portion of operating lease
liabilities
1,356
763
Total current liabilities
16,114
16,507
Deferred revenue, net of current
portion
1,394
2,221
Operating lease liabilities, net of
current portion
24,184
24,542
Total liabilities
41,692
43,270
Total stockholders’ equity
311,264
320,740
Total liabilities and stockholders’
equity
$
352,956
$
364,010
Janux Therapeutics,
Inc.
Unaudited Condensed Statements
of Operations and Comprehensive Loss
(in thousands, except share
and per share data)
Three Months Ended March
31,
2023
2022
Collaboration revenue
$
2,048
$
1,589
Operating expenses:
Research and development
15,865
10,184
General and administrative
6,464
4,947
Total operating expenses
22,329
15,131
Loss from operations
(20,281
)
(13,542
)
Total other income
2,822
132
Net loss
$
(17,459
)
$
(13,410
)
Other comprehensive loss:
Unrealized gain (loss) on
available-for-sale securities, net
796
(1,567
)
Comprehensive loss
$
(16,663
)
$
(14,977
)
Net loss per common share, basic and
diluted
$
(0.42
)
$
(0.32
)
Weighted-average shares of common stock
outstanding, basic and diluted
41,763,971
41,315,482
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509006173/en/
Investors: Andy Meyer Janux Therapeutics
ameyer@januxrx.com (202) 215-2579
Media: Jessica Yingling, Ph.D. Little Dog Communications
Inc. jessica@litldog.com (858) 344-8091
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