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Form 8-K

sec.gov

8-K — Janux Therapeutics, Inc.

Accession: 0001193125-26-211964

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001817713

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — janx-20260507.htm (Primary)

EX-99.1 (janx-ex99_1.htm)

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8-K

8-K (Primary)

Filename: janx-20260507.htm · Sequence: 1

8-K

false000181771300018177132026-05-072026-05-07

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): May 7, 2026

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 May 7, 2026, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2026. 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 May 7, 2026

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: May 7, 2026

By:

/s/ David Campbell, Ph.D.

David Campbell, Ph.D.

President and Chief Executive Officer

EX-99.1

EX-99.1

Filename: janx-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Janux Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

JANX007 continues to enroll in its Phase 1b taxane-naïve patient population, including combination cohorts with darolutamide

Initiated clinical evaluation of JANX014, a double-masked PSMA-TRACTr candidate

JANX011 Phase 1 study ongoing in healthy volunteers

Discontinued development of JANX008 following completion of Phase 1a

Achieved development candidate nomination under Bristol Myers Squibb collaboration, triggering milestone payment

Strong cash position supporting continued pipeline execution

SAN DIEGO, MAY 7, 2026 – Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the quarter ended March 31, 2026, and provided a business update.

“Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic,” said David Campbell, Ph.D., President and CEO of Janux. “Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity.”

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.

An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.

JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation.

Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities.

JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers.

The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Strategic Collaborations

Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform.

Recently announced development candidate nomination, triggering a $35 million milestone payment.

Corporate & Leadership

Janux announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, supporting the Company’s continued clinical advancement as additional programs enter the clinic in 2026.

Upcoming Milestones

Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027.

Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026.

Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of March 31, 2026, Janux reported cash and cash equivalents and short-term investments of $956.4 million, compared to $966.6 million on December 31, 2025.

Research and development expenses: Research and development expenses were $26.8 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. The change was primarily driven by manufacturing.

General and administrative expenses: General and administrative expenses were $11.1 million for the quarter ended March 31, 2026, compared to $9.8 million for the comparable period in 2025.

Net loss: Net loss was $24.4 million for the quarter ended March 31, 2026, compared to $23.5 million for the comparable period in 2025.

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’s lead clinical candidate, JANX007, is a PSMA-targeted TRACTr being investigated in a Phase 1 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company is also advancing additional PSMA-targeted programs, including JANX014, a double-masked PSMA TRACTr being evaluated in a Phase 1 clinical trial, and JANX013, a CD28 co-stimulatory TRACIr designed for combination with JANX007.

Beyond its prostate cancer programs, Janux’s pipeline includes JANX011, a CD19-targeted ARM being evaluated in a Phase 1 clinical trial in healthy adult volunteers for potential treatment of autoimmune diseases. Janux continues to generate additional TRACTr, TRACIr, and ARM programs for potential future development.

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)

March 31,

2026

December 31,

2025

Assets

(unaudited)

Current assets:

Cash and cash equivalents

$

51,828

$

52,334

Accounts receivable, net

35,000

Short-term investments

904,558

914,233

Prepaid expenses and other current assets

10,663

9,320

Total current assets

1,002,049

975,887

Restricted cash

816

816

Property and equipment, net

3,546

3,852

Operating lease right-of-use assets

17,870

18,402

Other long-term assets

3,944

2,608

Total assets

$

1,028,225

$

1,001,565

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

3,376

$

4,971

Accrued expenses

15,476

17,633

Current portion of deferred revenue

37,591

Current portion of operating lease liabilities

2,472

2,393

Total current liabilities

58,915

24,997

Deferred revenue, net of current portion

8,676

Operating lease liabilities, net of current portion

19,099

19,746

Total liabilities

86,690

44,743

Total stockholders’ equity

941,535

956,822

Total liabilities and stockholders’ equity

$

1,028,225

$

1,001,565

Janux Therapeutics, Inc.

Unaudited Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Three Months Ended

March 31,

2026

2025

Collaboration revenue

$

3,733

$

Operating expenses:

Research and development

26,813

25,055

General and administrative

11,133

9,842

Total operating expenses

37,946

34,897

Loss from operations

(34,213

)

(34,897

)

Total other income

9,852

11,389

Net loss

$

(24,361

)

$

(23,508

)

Other comprehensive gain (loss):

Unrealized gain (loss) on available-for-sale securities, net

(3,740

)

1,593

Comprehensive loss

$

(28,101

)

$

(21,915

)

Net loss per common share, basic and diluted

$

(0.39

)

$

(0.38

)

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

62,665,717

61,791,721

Contacts

Investors:

Chad Rubin

Endurance Advisors

crubin@enduranceadvisors.com

646.319.3261

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

858.344.8091

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