SAN DIEGO--(BUSINESS WIRE)--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, 2024, and provided a business update.
“Our efforts remain focused on enrolling participants in the PSMA-TRACTr (JANX007) and EGFR-TRACTr (JANX008) clinical trials, and we are encouraged by our continued progress,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics. “We look forward to providing an update on our JANX007 program by year end.”
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
- The company continues to enroll patients in the first-in-human Phase 1 clinical trials of JANX007 in mCRPC (NCT05519449) and JANX008 in advanced or metastatic solid tumors (NCT05783622). Janux anticipates providing an update on JANX007 data and doses selected for expansion cohorts in 2024. An update on JANX008 data is expected in 2025.
THIRD QUARTER 2024 FINANCIAL RESULTS:
- Cash and cash equivalents and short-term investments: As of September 30, 2024, Janux reported cash and cash equivalents and short-term investments of $658.0 million compared to $344.0 million at December 31, 2023.
- Research and development expenses: Research and development expenses for the quarter ended September 30, 2024, were $18.6 million compared to $11.9 million for the comparable period in 2023.
- General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2024, were $17.7 million compared to $6.4 million for the comparable period in 2023. With respect to the quarter ended September 30, 2024, $9.5 million of the general and administrative expense incurred was due to stock-based compensation expense associated with equity modifications.
- Net loss: For the quarter ended September 30, 2024, Janux reported a net loss of $28.1 million compared to a net loss of $11.6 million for the comparable period in 2023.
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 carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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 carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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.
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September 30,
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December 31,
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Assets |
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(unaudited) |
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Current assets: |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
26,754 |
|
|
$ |
19,205 |
Short-term investments |
|
|
631,277 |
|
|
|
324,823 |
Prepaid expenses and other current assets |
|
|
8,290 |
|
|
|
5,213 |
Total current assets |
|
|
666,321 |
|
|
|
349,241 |
Restricted cash |
|
|
816 |
|
|
|
816 |
Property and equipment, net |
|
|
5,373 |
|
|
|
7,003 |
Operating lease right-of-use assets |
|
|
19,686 |
|
|
|
20,838 |
Other long-term assets |
|
|
2,823 |
|
|
|
2,509 |
Total assets |
|
$ |
695,019 |
|
|
$ |
380,407 |
|
|
|
|
|
|
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Liabilities and Stockholders’ Equity |
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|
|
|
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Current liabilities: |
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|
|
|
|
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Accounts payable |
|
$ |
2,462 |
|
|
$ |
2,424 |
Accrued expenses |
|
|
13,022 |
|
|
|
7,387 |
Current portion of deferred revenue |
|
|
— |
|
|
|
1,705 |
Current portion of operating lease liabilities |
|
|
1,689 |
|
|
|
1,517 |
Total current liabilities |
|
|
17,173 |
|
|
|
13,033 |
Operating lease liabilities, net of current portion |
|
|
21,742 |
|
|
|
23,025 |
Total liabilities |
|
|
38,915 |
|
|
|
36,058 |
Total stockholders’ equity |
|
|
656,104 |
|
|
|
344,349 |
Total liabilities and stockholders’ equity |
|
$ |
695,019 |
|
|
$ |
380,407 |
Janux Therapeutics, Inc.
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Three Months Ended
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Nine Months Ended
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2024 |
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2023 |
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|
2024 |
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|
2023 |
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Collaboration revenue |
|
$ |
439 |
|
|
|
$ |
2,517 |
|
|
|
$ |
10,588 |
|
|
|
$ |
5,622 |
|
Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
18,614 |
|
|
|
|
11,892 |
|
|
|
|
47,582 |
|
|
|
|
42,681 |
|
General and administrative |
|
|
17,667 |
|
|
|
|
6,438 |
|
|
|
|
32,831 |
|
|
|
|
19,783 |
|
Total operating expenses |
|
|
36,281 |
|
|
|
|
18,330 |
|
|
|
|
80,413 |
|
|
|
|
62,464 |
|
Loss from operations |
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|
(35,842 |
) |
|
|
(15,813 |
) |
|
|
(69,825 |
) |
|
|
(56,842 |
) |
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Total other income |
|
|
7,783 |
|
|
|
|
4,245 |
|
|
|
|
21,047 |
|
|
|
|
10,307 |
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Net loss |
|
$ |
(28,059 |
) |
|
$ |
(11,568 |
) |
|
$ |
(48,778 |
) |
|
$ |
(46,535 |
) |
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Other comprehensive gain (loss): |
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|
|
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on available-for-sale securities, net |
|
|
9,447 |
|
|
|
|
(115 |
) |
|
|
7,166 |
|
|
|
|
360 |
|
|
Comprehensive loss |
|
$ |
(18,612 |
) |
|
$ |
(11,683 |
) |
|
$ |
(41,612 |
) |
|
$ |
(46,175 |
) |
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Net loss per common share, basic and diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.93 |
) |
|
$ |
(1.08 |
) |
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Weighted-average shares of common stock outstanding, basic and diluted |
|
|
54,628,670 |
|
|
|
|
45,708,649 |
|
|
|
|
52,717,020 |
|
|
|
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43,117,403 |
|
