Form 8-K - Current report

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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, 2024

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: [phone]

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. ☒

 

 

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Item 2.02 Results of Operations and Financial Condition.

On November 6, 2024, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 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 November 6, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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

 

 

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	Exhibit 99.1

 

Janux Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights

 

•

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

 

SAN DIEGO, November 6, 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).

 

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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.

 

 

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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

 

 

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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

 

Contacts

 

Investors:

Andy Meyer

Janux Therapeutics

[e-mail]

[phone]

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

[e-mail]

[phone]

 

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Document and Entity Information	Nov. 06, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001817713
Document Type	8-K
Document Period End Date	Nov. 06, 2024
Entity Registrant Name	Janux Therapeutics, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-40475
Entity Tax Identification Number	82-2289112
Entity Address, Address Line One	10955 Vista Sorrento Parkway
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	858
Local Phone Number	751-4493
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.001 par value per share
Trading Symbol	JANX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Information, Former Legal or Registered Name	N/A

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