8-K
Janux Therapeutics, Inc. (JANX)
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): February 27, 2025
Janux Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-40475 | 82-2289112 |
|---|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 10955 Vista Sorrento Parkway, Suite 200<br><br>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<br><br>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 February 27, 2025, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2024. 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 February 27, 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: February 27, 2025 | By: | /s/ David Campbell, Ph.D. |
| David Campbell, Ph.D. | ||
| President and Chief Executive Officer |
EX-99.1
| Exhibit 99.1 |
|---|
Janux Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
- Recently presented positive Phase 1 clinical trial data for PSMA-TRACTr JANX007 in mCRPC
- Enrollment ongoing for JANX007 and JANX008
- Update on JANX007 and JANX008 data is anticipated in 2025
- R&D Day is anticipated in 2025 to disclose new programs moving toward the clinic
- $1.03 billion in year-end cash, cash equivalents, and short-term investments
SAN DIEGO, February 27, 2025 – 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 fourth quarter and full year ended December 31, 2024, and provided a business update.
“2024 was an exceptional year for Janux as we displayed the potential power of our TRACTr platform in the clinic. We believe the data recently presented from JANX007 demonstrated substantial clinical activity in late line mCRPC patients, supporting our future clinical development plans directed at earlier line patients. With our substantial cash runway, we feel well-positioned to execute on our clinical plans, as well as bring new programs towards the clinic that could provide substantial value to both Janux, and more importantly, the patients we serve,” said David Campbell, Ph.D., President and CEO of Janux.
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in December 2024. As of the November 15, 2024, data cutoff in 16 patients JANX007 displayed:
High prostate-specific antigen (PSA) response rates: 100% achieved best PSA50 declines.
Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines.
Durable PSA declines maintained at ≥ 12 weeks: 75% maintained PSA 50 declines; 50% maintained PSA90 declines.
Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8) (including confirmed and unconfirmed).
Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and lower grades.
Gross proceeds of approximately $402.5 million (before deducting underwriting discounts and commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in December 2024.
Janux to host R&D Day in 2025.
Janux plans to provide an update on pipeline programs selected for clinical development.
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).
Zachariah McIver, D.O., Ph.D. promoted to Chief Medical Officer. Dr. McIver has been instrumental in executing on Janux’s clinical programs. Dr. McIver continues to lead cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies. An accomplished physician-scientist with over 15-years of experience in clinical research, Dr. McIver joined Janux after serving as Amgen’s Executive Medical Director for over 4 years.
An update on JANX007 and JANX008 data is anticipated in 2025. Janux will also be hosting an R&D Day in 2025.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS:
Cash and cash equivalents and short-term investments: As of December 31, 2024, Janux reported cash and cash equivalents and short-term investments of $1.03 billion compared to $344.0 million at December 31, 2023.
Research and development expenses: Research and development expenses were $20.8 million for the quarter and $68.4 million for the year ended December 31, 2024, compared to $12.2 million and $54.9 million for the same quarter and year in 2023.
General and administrative expenses: General and administrative expenses were $8.2 million for the quarter and $41.0 million for the year ended December 31, 2024, compared to $6.4 million and $26.1 million for the same quarter and year in 2023.
Net loss: Net loss was $20.2 million for the quarter and $69.0 million for the year ended December 31, 2024, compared to $11.8 million and $58.3 million for the same quarter and year in 2023.
Janux’s TRACTr and TRACIr 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 metastatic castration-resistant prostate cancer (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. 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: TRACTr and 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)
| December 31, | ||||
|---|---|---|---|---|
| Assets | 2024 | 2023 | ||
| Current assets: | ||||
| Cash and cash equivalents | $ | 430,605 | $ | 19,205 |
| Short-term investments | 594,568 | 324,823 | ||
| Prepaid expenses and other current assets | 8,493 | 5,213 | ||
| Total current assets | 1,033,666 | 349,241 | ||
| Restricted cash | 816 | 816 | ||
| Property and equipment, net | 4,864 | 7,003 | ||
| Operating lease right-of-use assets | 19,286 | 20,838 | ||
| Other long-term assets | 2,884 | 2,509 | ||
| Total assets | $ | 1,061,516 | $ | 380,407 |
| Liabilities and Stockholders’ Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 4,026 | $ | 2,424 |
| Accrued expenses | 11,684 | 7,387 | ||
| Current portion of deferred revenue | — | 1,705 | ||
| Current portion of operating lease liabilities | 1,749 | 1,517 | ||
| Total current liabilities | 17,459 | 13,033 | ||
| Operating lease liabilities, net of current portion | 21,276 | 23,025 | ||
| Total liabilities | 38,735 | 36,058 | ||
| Total stockholders’ equity | 1,022,781 | 344,349 | ||
| Total liabilities and stockholders’ equity | $ | 1,061,516 | $ | 380,407 |
Janux Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended<br> December 31, | Year Ended<br>December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Collaboration revenue | $ | — | $ | 2,461 | $ | 10,588 | $ | 8,083 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 20,806 | 12,241 | 68,388 | 54,922 | ||||||||
| General and administrative | 8,216 | 6,357 | 41,047 | 26,140 | ||||||||
| Total operating expenses | 29,022 | 18,598 | 109,435 | 81,062 | ||||||||
| Loss from operations | (29,022 | ) | (16,137 | ) | (98,847 | ) | (72,979 | ) | ||||
| Total other income | 8,806 | 4,379 | 29,853 | 14,686 | ||||||||
| Net loss | $ | (20,216 | ) | $ | (11,758 | ) | $ | (68,994 | ) | $ | (58,293 | ) |
| Other comprehensive gain (loss): | ||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net | (5,668 | ) | 1,840 | 1,498 | 2,200 | |||||||
| Comprehensive loss | $ | (25,884 | ) | $ | (9,918 | ) | $ | (67,496 | ) | $ | (56,093 | ) |
| Net loss per common share, basic and diluted | $ | (0.36 | ) | $ | (0.25 | ) | $ | (1.28 | ) | $ | (1.32 | ) |
| Weighted-average shares of common stock outstanding, basic and diluted | 56,832,374 | 46,683,613 | 53,751,480 | 44,016,283 |
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