JANX Janux Therapeutics Inc

 

 

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): August 8, 2023

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. ☒

 

 

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Item 2.02 Results of Operations and Financial Condition.

On August 8, 2023, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2023. 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 8.01 Other Events.

As previously disclosed by the Company in its Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2023, as a result of Peter Thompson, M.D., a former independent member of the Company’s Board of Directors (the “Board”), not standing for re-election at the Company’s 2023 Annual Meeting of Stockholders, the Company received a letter from the Nasdaq Stock Market LLC (“Nasdaq”) on June 16, 2023 specifying that the Company no longer complied with Nasdaq’s majority independent directors requirement set forth in Nasdaq Listing Rule 5605(b)(1) and that Nasdaq would provide the Company a cure period in order to regain compliance with such Rule. Recently, Ron Barrett, Ph.D., a member of the Board, became an independent director as defined in Nasdaq Listing Rule 5605(a)(2). On August 1, 2023, the Company received a letter from Nasdaq noting that, as a result of Dr. Barrett becoming an independent director, Nasdaq has determined that the Company has regained compliance with the Rule and the matter is now closed.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release of Janux Therapeutics, Inc. dated August 8, 2023
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: August 8, 2023		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 Second Quarter 2023 Financial Results and Business Highlights

 

- Presented positive interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer

- Management team bolstered with key appointment

- $303.3 million in cash, cash equivalents, and short-term investments at end of second quarter 2023

- In July, further strengthened balance sheet with approximately $60 million offering

 

SAN DIEGO, August 8, 2023 – 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 second quarter ended June 30, 2023, and provided a business update.

 

“The combination of our positive proof of principle interim clinical data from JANX007 and our ability to secure additional capital gives us confidence to drive forward the next wave of assets from our TRACTr and TRACIr portfolios,” said David Campbell, Ph.D., President and CEO of Janux. “We continue to believe we can leverage our technology to rapidly identify exciting targets, develop differentiated molecules against those targets, and advance those programs into the clinic, creating value for Janux, and more importantly new meaningful therapies for cancer patients.”

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

 

 

 

 

 

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SECOND QUARTER 2023 FINANCIAL HIGHLIGHTS:

 

 

 

 

 

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). 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 cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

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, lung, head and neck, and renal cancers. For more information, please visit www.januxrx.com and follow us on LinkedIn.

 

 

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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)

		June 30, 2023				December 31, 2022
Assets		(unaudited)
Current assets:
Cash and cash equivalents		$	33,703			$	51,426
Short-term investments			269,586				275,590
Prepaid expenses and other current assets			6,013				5,423
Total current assets			309,302				332,439
Restricted cash			816				816
Property and equipment, net			7,378				7,086
Operating lease right-of-use assets			21,571				22,279
Other long-term assets			2,433				1,390
Total assets		$	341,500			$	364,010
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	1,910			$	2,159
Accrued liabilities			9,216				8,010
Current portion of deferred revenue			5,340				5,406
Unvested stock liabilities			30				169
Current portion of operating lease liabilities			1,408				763
Total current liabilities			17,904				16,507
Deferred revenue, net of current portion			307				2,221
Operating lease liabilities, net of current portion			23,820				24,542
Total liabilities			42,031				43,270
Total stockholders’ equity			299,469				320,740
Total liabilities and stockholders’ equity		$	341,500			$	364,010

 

 

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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 June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Collaboration revenue		$	1,057			$	2,365			$	3,105			$	3,954
Operating expenses:
Research and development			14,924				14,086				30,789				24,270
General and administrative			6,881				5,540				13,345				10,487
Total operating expenses			21,805				19,626				44,134				34,757
Loss from operations			(20,748	)			(17,261	)			(41,029	)			(30,803	)
Total other income			3,240				373				6,062				505
Net loss		$	(17,508	)		$	(16,888	)		$	(34,967	)		$	(30,298	)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities, net			(321	)			(340	)			475				(1,637	)
Comprehensive loss		$	(17,829	)		$	(17,228	)		$	(34,492	)		$	(31,935	)
Net loss per common share, basic and diluted		$	(0.42	)		$	(0.41	)		$	(0.84	)		$	(0.73	)
Weighted-average shares of common stock outstanding, basic and diluted			41,836,238				41,448,743				41,800,304				41,382,481

 

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

 

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v3.23.2

Document and Entity Information	Aug. 08, 2023
Cover [Abstract]
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Entity Central Index Key	0001817713
Document Type	8-K
Document Period End Date	Aug. 08, 2023
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
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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

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