- Enrollment ongoing for PSMA-TRACTr (JANX007) in prostate
cancer
- Enrollment ongoing for EGFR-TRACTr (JANX008) in solid
tumors
- Update on clinical programs expected in 2024
- $349.7 million in cash, cash equivalents, and short-term
investments at end of third quarter 2023
- Cash and investments projected to support current operating
plan through 2027 to generate Phase 1b data for our PSMA and
EGFR-TRACTr programs
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 third quarter ended September 30, 2023,
and provided a business update.
“We are pleased with the enrollment in the two clinical studies
for our PSMA-TRACTr JANX007 and our EGFR-TRACTr JANX008,” said
David Campbell, Ph.D., President and CEO of Janux. “As we enter
2024, equipped with a strong financial foundation, we are committed
to advancing these clinical programs and expanding our pipeline so
that we can rapidly bring forward new meaningful therapies for
cancer patients.”
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
- PSMA-TRACTr (JANX007) continues to enroll in the
first-in-human Phase 1 clinical trial in mCRPC
(NCT05519449).
- EGFR-TRACTr (JANX008) continues to enroll in the
first-in-human Phase 1 clinical trial in advanced or metastatic
solid tumors (NCT05783622).
- PD-L1xCD28 TRACIr (JANX009) IND-enabling studies
completed.
- TROP2-TRACTr development candidate identification
completed.
Janux anticipates providing an update on its clinical programs
in 2024.
THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS:
- Cash and cash equivalents and short-term investments: As
of September 30, 2023, Janux reported cash and cash equivalents and
short-term investments of $349.7 million compared to $327.0 million
at December 31, 2022, which we project will be sufficient to fund
our current operating plan through 2027 to generate Phase 1b data
for our PSMA and EGFR-TRACTr programs.
- Research and development expenses: For the quarter ended
September 30, 2023, Janux reported research and development
expenses of $11.9 million compared to $13.7 million for the
comparable period in 2022.
- General and administrative expenses: For the quarter
ended September 30, 2023, Janux reported general and administrative
expenses of $6.4 million compared to $6.1 million for the
comparable period in 2022.
- Net loss: For the quarter ended September 30, 2023,
Janux reported a net loss of $11.6 million compared to $16.7
million for the comparable period in 2022.
Janux’s TRACTr and TRACIr Pipeline
Janux’s first clinical candidate, JANX007, is a TRACTr that
targets PSMA and is being investigated in a Phase 1 clinical trial
in adult subjects with metastatic castration-resistant prostate
cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a
TRACTr that targets 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 is also
applying its proprietary technology to develop a TRACTr designed to
target 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. 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 for the treatment of solid tumors. 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
tumor-activated immunotherapies for cancer. Janux’s proprietary
technology enabled the development of two distinct bispecific
platforms: Tumor Activated T Cell Engagers (TRACTr) and Tumor
Activated Immunomodulators (TRACIr). The goal of both platforms is
to provide cancer patients with safe and effective therapeutics
that direct and guide their immune system to eradicate tumors while
minimizing safety concerns. Janux is currently developing a broad
pipeline of TRACTr and TRACIr therapeutics directed at several
targets to treat solid tumors. Janux has two TRACTr therapeutic
candidates in clinical trials, the first targeting PSMA is in
development for prostate cancer, and the second targeting EGFR is
being developed for colorectal, lung, head and neck, and renal
cancers. 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 preclinical studies and 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 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)
September 30, 2023
December 31, 2022
Assets
(unaudited)
Current assets:
Cash and cash equivalents
$
17,152
$
51,426
Short-term investments
332,560
275,590
Prepaid expenses and other current
assets
5,483
5,423
Total current assets
355,195
332,439
Restricted cash
816
816
Property and equipment, net
7,317
7,086
Operating lease right-of-use assets
21,208
22,279
Other long-term assets
2,314
1,390
Total assets
$
386,850
$
364,010
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
2,505
$
2,159
Accrued liabilities
6,831
8,010
Current portion of deferred revenue
3,648
5,406
Unvested stock liabilities
25
169
Current portion of operating lease
liabilities
1,462
763
Total current liabilities
14,471
16,507
Deferred revenue, net of current
portion
—
2,221
Operating lease liabilities, net of
current portion
23,431
24,542
Total liabilities
37,902
43,270
Total stockholders’ equity
348,948
320,740
Total liabilities and stockholders’
equity
$
386,850
$
364,010
Janux Therapeutics,
Inc.
Unaudited Condensed Statements
of Operations and Comprehensive Loss
(in thousands, except share
and per share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Collaboration revenue
$
2,517
$
1,813
$
5,622
$
5,767
Operating expenses:
Research and development
11,892
13,737
42,681
38,007
General and administrative
6,438
6,098
19,783
16,585
Total operating expenses
18,330
19,835
62,464
54,592
Loss from operations
(15,813
)
(18,022
)
(56,842
)
(48,825
)
Total other income
4,245
1,326
10,307
1,831
Net loss
$
(11,568
)
$
(16,696
)
$
(46,535
)
$
(46,994
)
Other comprehensive loss:
Unrealized gain (loss) on
available-for-sale securities, net
(115
)
(370
)
360
(2,007
)
Comprehensive loss
$
(11,683
)
$
(17,066
)
$
(46,175
)
$
(49,001
)
Net loss per common share, basic and
diluted
$
(0.25
)
$
(0.40
)
$
(1.08
)
$
(1.13
)
Weighted-average shares of common stock
outstanding, basic and diluted
45,708,649
41,526,524
43,117,403
41,431,023
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231107781590/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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