- Recently presented positive Phase 1 clinical trial data for
PSMA-TRACTr JANX007 in mCRPC and for EGFR-TRACTr JANX008 in solid
tumors
- Enrollment ongoing for JANX007 and JANX008
- Update on JANX007 data and doses selected for expansion cohorts
is anticipated in 2H 2024
- $344.0 million in year-end cash, cash equivalents, and
short-term investments
- In March, further strengthened balance sheet with approximately
$320.2 million net proceeds from underwritten offering
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 fourth quarter and full year ended
December 31, 2023, and provided a business update.
“2023 was a critical year for Janux as we tested the potential
power of our TRACTr platform in the clinic. We believe the data
recently presented from both of our clinical programs displays the
profound impact we can have on patients through our tumor-activated
approach. We are excited to be helping cancer patients who need
novel therapies and with our substantial cash runway we feel
well-positioned to execute on our clinical plan,” said David
Campbell, Ph.D., President and CEO of Janux.
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
- Presented positive updated interim Phase 1 clinical trial
data for PSMA-TRACTr JANX007 in prostate cancer in February 2024.
As of February 12, 2024:
- Increasing depth of PSA declines and RECIST responses at higher
doses were observed, while a favorable safety profile was
maintained.
- 83% (5/6) of subjects achieved PSA50 declines with first step
dose ≥ 0.2mg.
- 56% (10/18) of subjects achieved PSA50 declines with first dose
≥ 0.1mg.
- No CRS > Grade 2 observed in heavily pre-treated late stage
mCRPC population.
- Majority of non-CRS treatment-related adverse events (TRAEs)
were Grade 1 or 2.
- Low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were
observed.
- JANX007 has been administered at doses up to 3mg, significantly
exceeding the anticipated maximum tolerable dose for the parental T
cell engager, while the maximum tolerable dose for the TRACTr has
not yet been established.
- Also presented positive interim Phase 1 clinical trial data
for EGFR-TRACTr JANX008 in solid tumors. As of February 12,
2024:
- A subject with NSCLC achieved a RECIST PR maintained through
18-weeks with 100% target lung lesion reduction and elimination of
liver metastasis with no CRS or TRAEs.
- No CRS greater than Grade 1 observed in any cohort.
- Majority of non-CRS TRAEs were Grade 1 or 2.
- No treatment-related SAEs or DLTs have been observed.
- Net proceeds of approximately $320.2 million (after
deducting underwriting discounts, commissions and other estimated
offering expenses) raised in an underwritten offering of common
stock and pre-funded warrants in March 2024.
- Janux plans to deploy these funds to expand development of
clinical programs, advance additional preclinical programs and
extend corporate runway.
- JANX007 continues to enroll in the first-in-human Phase 1
clinical trial in mCRPC (NCT05519449).
- JANX008 continues to enroll in the first-in-human Phase 1
clinical trial in advanced or metastatic solid tumors
(NCT05783622).
- Co-founder Dr. Tommy DiRaimondo promoted to Chief Scientific
Officer. Tommy was instrumental in successfully transitioning
Janux’s PSMA-TRACTr and EGFR-TRACTr programs from research into
clinical trials. Tommy continues to manage the internal and
external research operations and plays an integral role in managing
the IP, discovery, creation, optimization and expansion of Janux’s
preclinical pipeline.
An update on JANX007 data and doses selected for expansion
cohorts is anticipated in the second half of 2024.
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:
- Cash and cash equivalents and short-term investments: As
of December 31, 2023, Janux reported cash and cash equivalents and
short-term investments of $344.0 million compared to $327.0 million
at December 31, 2022.
- Research and development expenses: Research and
development expenses were $12.2 million for the quarter and $54.9
million for the year ended December 31, 2023, compared to $15.4
million and $53.4 million for the same quarter and year in
2022.
- General and administrative expenses: General and
administrative expenses were $6.4 million for the quarter and $26.1
million for the year ended December 31, 2023, compared to $5.7
million and $22.3 million for the same quarter and year in
2022.
- Net loss: Net loss was $11.8 million for the quarter and
$58.3 million for the year ended December 31, 2023, compared to
$16.1 million and $63.1 million for the same quarter and year 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. We are also
generating a number of additional TRACTr and TRACIr programs for
potential future development, some of which are at development
candidate stage or later. We are currently assessing priorities in
our preclinical pipeline.
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)
December 31,
Assets
2023
2022
Current assets:
Cash and cash equivalents
$
19,205
$
51,426
Short-term investments
324,823
275,590
Prepaid expenses and other current
assets
5,213
5,423
Total current assets
349,241
332,439
Restricted cash
816
816
Property and equipment, net
7,003
7,086
Operating lease right-of-use assets
20,838
22,279
Other long-term assets
2,509
1,390
Total assets
$
380,407
$
364,010
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
2,424
$
2,159
Accrued expenses
7,387
8,179
Current portion of deferred revenue
1,705
5,406
Current portion of operating lease
liabilities
1,517
763
Total current liabilities
13,033
16,507
Deferred revenue, net of current
portion
—
2,221
Operating lease liabilities, net of
current portion
23,025
24,542
Total liabilities
36,058
43,270
Total stockholders’ equity
344,349
320,740
Total liabilities and stockholders’
equity
$
380,407
$
364,010
Janux Therapeutics,
Inc.
Condensed Statements of
Operations and Comprehensive Loss
(in thousands, except share
and per share data)
Three Months Ended
December 31,
Year Ended
December 31,
2023
2022
2023
2022
Collaboration revenue
$
2,461
$
2,845
$
8,083
$
8,612
Operating expenses:
Research and development
12,241
15,434
54,922
53,441
General and administrative
6,357
5,677
26,140
22,262
Total operating expenses
18,598
21,111
81,062
75,703
Loss from operations
(16,137
)
(18,266
)
(72,979
)
(67,091
)
Total other income
4,379
2,201
14,686
4,032
Net loss
$
(11,758
)
$
(16,065
)
$
(58,293
)
$
(63,059
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities, net
1,840
742
2,200
(1,265
)
Comprehensive loss
$
(9,918
)
$
(15,323
)
$
(56,093
)
$
(64,324
)
Net loss per common share, basic and
diluted
$
(0.25
)
$
(0.39
)
$
(1.32
)
$
(1.52
)
Weighted-average shares of common stock
outstanding, basic and diluted
46,683,613
41,584,195
44,016,283
41,469,631
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240308492974/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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