JANX Janux Therapeutics Inc

• Enrollment ongoing for PSMA-TRACTr (JANX007) in prostate cancer and EGFR-TRACTr (JANX008) in solid tumors
• Update on JANX007 data and doses selected for expansion cohorts is anticipated in 2024
• $658.0 million in cash and cash equivalents and short-term investments at end of third quarter 2024

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. Condensed Balance Sheets (in thousands)

 

 

September 30, 2024

 

 

December 31, 2023

Assets

 

(unaudited)

 

 

 

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

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

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. 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,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

Collaboration revenue

 

$

439

 

 

 

$

2,517

 

 

 

$

10,588

 

 

 

$

5,622

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(35,842

)

 

 

(15,813

)

 

 

(69,825

)

 

 

(56,842

)

Total other income

 

 

7,783

 

 

 

 

4,245

 

 

 

 

21,047

 

 

 

 

10,307

 

Net loss

 

$

(28,059

)

 

$

(11,568

)

 

$

(48,778

)

 

$

(46,535

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

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

)

Net loss per common share, basic and diluted

 

$

(0.51

)

 

$

(0.25

)

 

$

(0.93

)

 

$

(1.08

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

54,628,670

 

 

 

 

45,708,649

 

 

 

 

52,717,020

 

 

 

 

43,117,403

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20241106263536/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