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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 6, 2025

Janux Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-40475

82-2289112

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

10955 Vista Sorrento Parkway, Suite 200

San Diego, California

92130

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 751-4493

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

JANX

 

Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On November 6, 2025, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Item and the exhibit attached hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

Description

99.1

Press Release of Janux Therapeutics, Inc. dated November 6, 2025

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

JANUX THERAPEUTICS, INC.

Date: November 6, 2025

By:

/s/ David Campbell, Ph.D.

David Campbell, Ph.D.

President and Chief Executive Officer

 

 


EX-99.1 2 janx-ex99_1.htm EX-99.1 EX-99.1

img201480580_0.jpg

Exhibit 99.1

 

 

Janux Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

 

Enrollment ongoing for JANX007 and JANX008
Updates on JANX007 and JANX008 expected in the fourth quarter of 2025
$989.0 million in cash, cash equivalents, and short-term investments at end of third quarter 2025

 

SAN DIEGO, November 6, 2025 – Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the third quarter ended September 30, 2025, and provided a business update.

"With enrollment ongoing in the JANX007 and JANX008 clinical trials and multiple new drug candidates expected to enter the clinic next year, we remain confident in our ability to advance these programs, supported by a strong balance sheet that enables continued execution,” said David Campbell, Ph.D., President and CEO of Janux.

 

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

 

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).

 

Additional data from JANX007 and JANX008 will be presented at future Janux events in the fourth quarter of 2025.

 

THIRD QUARTER 2025 FINANCIAL RESULTS:

 

Cash and cash equivalents and short-term investments: As of September 30, 2025, Janux reported cash and cash equivalents and short-term investments of $989.0 million, compared to $1.03 billion at December 31, 2024.

 

Research and development expenses: Research and development expenses for the quarter ended September 30, 2025 were $34.6 million, compared to $18.6 million for the comparable period in 2024.

 

General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2025 were $10.6 million, compared to $17.7 million for the comparable period in 2024. 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, 2025, Janux reported a net loss of $24.3 million, compared to a net loss of $28.1 million for the comparable period in 2024.

 

 


 

Janux’s TRACTr, TRACIr and ARM Pipeline

 

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 patients with mCRPC. Janux’s second clinical candidate, 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 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. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

About Janux Therapeutics

 

Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Janux Therapeutics, Inc.

Condensed Balance Sheets

(in thousands)

 

 

September 30,
2025

 

 

December 31,
2024

 

Assets

 

(unaudited)

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

48,389

 

 

$

430,605

 

Short-term investments

 

 

940,604

 

 

 

594,568

 

Prepaid expenses and other current assets

 

 

9,093

 

 

 

8,493

 

Total current assets

 

 

998,086

 

 

 

1,033,666

 

Restricted cash

 

 

816

 

 

 

816

 

Property and equipment, net

 

 

4,314

 

 

 

4,864

 

Operating lease right-of-use assets

 

 

18,923

 

 

 

19,286

 

Other long-term assets

 

 

2,627

 

 

 

2,884

 

Total assets

 

$

1,024,766

 

 

$

1,061,516

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,395

 

 

$

4,026

 

Accrued expenses

 

 

22,156

 

 

 

11,684

 

Current portion of operating lease liabilities

 

 

2,280

 

 

 

1,749

 

Total current liabilities

 

 

27,831

 

 

 

17,459

 

Operating lease liabilities, net of current portion

 

 

20,380

 

 

 

21,276

 

Total liabilities

 

 

48,211

 

 

 

38,735

 

Total stockholders’ equity

 

 

976,555

 

 

 

1,022,781

 

Total liabilities and stockholders’ equity

 

$

1,024,766

 

 

$

1,061,516

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

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,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Collaboration revenue

 

$

10,000

 

 

$

439

 

 

$

10,000

 

 

$

10,588

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

34,629

 

 

 

18,614

 

 

 

94,348

 

 

 

47,582

 

General and administrative

 

 

10,622

 

 

 

17,667

 

 

 

30,918

 

 

 

32,831

 

Total operating expenses

 

 

45,251

 

 

 

36,281

 

 

 

125,266

 

 

 

80,413

 

Loss from operations

 

 

(35,251

)

 

 

(35,842

)

 

 

(115,266

)

 

 

(69,825

)

Total other income

 

 

10,938

 

 

 

7,783

 

 

 

33,587

 

 

 

21,047

 

Net loss

 

$

(24,313

)

 

$

(28,059

)

 

$

(81,679

)

 

$

(48,778

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities, net

 

 

815

 

 

 

9,447

 

 

 

2,399

 

 

 

7,166

 

Comprehensive loss

 

$

(23,498

)

 

$

(18,612

)

 

$

(79,280

)

 

$

(41,612

)

Net loss per common share, basic and diluted

 

$

(0.39

)

 

$

(0.51

)

 

$

(1.32

)

 

$

(0.93

)

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

 

 

62,023,685

 

 

 

54,628,670

 

 

 

61,906,789

 

 

 

52,717,020

 

 

Contacts

 

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