Janux Therapeutics Files 8-K

Ticker: JANX · Form: 8-K · Filed: Dec 2, 2024 · CIK: 1817713

Janux Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyJanux Therapeutics, Inc. (JANX)
Form Type8-K
Filed DateDec 2, 2024
Risk Levellow
Pages4
Reading Time5 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k, financials

TL;DR

Janux Therapeutics filed an 8-K, likely with financial updates and other disclosures.

AI Summary

On December 2, 2024, Janux Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates that Janux Therapeutics, Inc. is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The provided text is a standard SEC filing notification without specific material events or financial details that would indicate high risk.

Key Players & Entities

  • Janux Therapeutics, Inc. (company) — Registrant
  • 0000950170-24-132302 (other) — Accession Number
  • December 2, 2024 (date) — Date of Report
  • 10955 Vista Sorrento Parkway, Suite 200, San Diego, California 92130 (location) — Principal Executive Offices

FAQ

What specific events are disclosed in this 8-K filing?

The filing indicates disclosures related to Regulation FD, Other Events, and Financial Statements and Exhibits, but specific details are not provided in the excerpt.

When was this 8-K report filed?

The report was filed on December 2, 2024.

What is the principal business of Janux Therapeutics, Inc.?

Janux Therapeutics, Inc. is in the Pharmaceutical Preparations industry, SIC code 2834.

Where is Janux Therapeutics, Inc. headquartered?

The company's principal executive offices are located at 10955 Vista Sorrento Parkway, Suite 200, San Diego, California 92130.

What is the Commission File Number for Janux Therapeutics, Inc.?

The Commission File Number for Janux Therapeutics, Inc. is 001-40475.

Filing Stats: 1,305 words · 5 min read · ~4 pages · Grade level 13 · Accepted 2024-12-02 17:10:46

Key Financial Figures

  • $0.001 — nge on which registered Common Stock, $0.001 par value per share JANX Nasdaq Glo

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 2, 2024, Janux Therapeutics, Inc. (the "Company") issued a press release announcing interim clinical data for its JANX007 clinical program and is also making available a corporate presentation reporting such interim clinical data. Copies of the press release and the corporate presentation are attached as Exhibits 99.1 and 99.2, respectively, to this report. The corporate presentation will also be available under the "Investors" section of the Company's website. The information in this Item 7.01 of this report (including Exhibits 99.1 and 99.2) is furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today's date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

01 Other Events

Item 8.01 Other Events. On December 2, 2024, the Company announced updated interim clinical data for its JANX007 clinical program. Updated interim, clinical data for PSMA-TRACTr JANX007 in mCRPC as of November 15, 2024 JANX007 is in a Phase 1a clinical trial in patients with advanced or metastatic prostate cancer ("mCRPC"). The patients enrolled in the trial were heavily pre-treated with a median of four prior lines of therapy. As of the November 15, 2024 data cutoff, 16 pre-PLUVICTO patients have been treated once-weekly at a target dose ranging from 2 mg to 9 mg in the Phase 1a clinical trial. High prostate-specific antigen ("PSA") response rates and deep PSA declines were observed across all doses; 100% of patients achieved best PSA 50 declines, 63% of patients achieved best PSA 90 declines, and 31% of patients achieved best PSA 99 declines. Durability of PSA declines at a target dose 2 mg were observed; 75% of patients maintained PSA 50 declines at 12 weeks and 50% of patients maintained PSA 90 declines at 12 weeks. Deep and durable PSA responses were observed irrespective of resistance driver aberration status, or prior treatments with a taxane or ARPi. In RECIST-evaluable patients, anti-tumor activity was observed with confirmed and unconfirmed partial responses in 50% (4/8) of patients. JANX007 was well-tolerated with cytokine release syndrome ("CRS") and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. Similarly, treatment-related adverse events not associated with CRS were primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached. Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-PLUVICTO 2L and 3L patients. The Company anticipates providing another update on JANX007 in 2025.

Forward-Looking Statements

Forward-Looking Statements This report 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, the Company's ability to bring new treatments to cancer patients in need, expectations regarding the timing, scope and results of the Company's development activities, including its ongoing and planned clinical trials and that the interim data results support continued clinical development of JANX007, including in pre-PLUVICTO 2L and 3L patients, and the potential benefits of the Company's product candidates and platform technologies. 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 the Company 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

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release, dated December 2, 2024. 99.2 Corporate Presentation. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 2

SIGNATURES

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: December 2, 2024 By: /s/ David Campbell, Ph.D. David Campbell, Ph.D. President and Chief Executive Officer 3

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