8-K

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): March 10, 2023

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 March 10, 2023, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2022. 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 March 10, 2023
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: March 10, 2023	By:	/s/ David Campbell, Ph.D.
		David Campbell, Ph.D.
		President and Chief Executive Officer

EX-99

Exhibit 99.1

Janux Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

-Interim clinical update from Phase 1 trial of JANX007 expected in 2H 2023-

-FDA clearance granted for Investigational New Drug (IND) application for EGFR-TRACTr (JANX008)-

-$327.0 million in year-end cash and cash equivalents and short-term investments-

SAN DIEGO, March 10, 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 fourth quarter and full year ended December 31, 2022, and provided a business update.

“Janux made great strides in 2022 as we transitioned to a clinical-stage company by dosing the first patient with our PSMA-TRACTr and advancing our pipeline utilizing our novel TRACTr and TRACIr platforms. We recently received IND clearance from the FDA for our EGFR-TRACTr, keeping us on track to enter a second program into the clinic. Importantly, this milestone underscores our ability to reproducibly bring novel immunotherapies through development and deliver them to patients. Two of our core values at Janux are ‘collaboration’ and ‘urgency,’ and both were on display in connection with hitting these milestones,” said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

Janux has prioritized its programs to enable sufficient funding to provide key clinical data assessments for

its lead programs. Janux is aware of recent media reports related to the closure of Silicon Valley Bank (“SVB”). Janux considers its exposure to any liquidity concern at SVB as immaterial and will have no impact on its short- or long-term objectives. In addition, none of Janux’s investment portfolio contains direct exposure to SVB.

• Lead program PSMA-TRACTr (JANX007) continues to enroll in first-in-human Phase 1 clinical trial in prostate cancer patients.

• Janux received U.S. Food and Drug Administration (FDA) clearance for an IND application for EGFR-TRACTr (JANX008).

• PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission in 2023.

• TROP2-TRACTr evaluations to support development candidate selection are ongoing.

Janux anticipates providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023. In addition, Janux expects to select a development candidate for its TROP2-TRACTr in 2023.

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS:

• Cash and cash equivalents and short-term investments: As of December 31, 2022, Janux reported cash and cash equivalents and short-term investments of $327.0 million, compared to $375.0 million at December 31, 2021.

• Research and development expenses: Research and development expenses were $15.4 million for the quarter and $53.4 million for the year ended December 31, 2022, compared to $11.2 million and $26.2 million for the same quarter and year in 2021.

• General and administrative expenses: General and administrative expenses were $5.7 million for the quarter and $22.3 million for the year ended December 31, 2022, compared to $3.9 million and $10.3 million for the same quarter and year in 2021.

• Net loss: Net loss was $16.1 million for the quarter and $63.1 million for the year ended December 31, 2022, compared to $13.4 million and $32.7 million for the same quarter and year in 2021.

Janux’s TRACTr and TRACIr Pipeline

Janux’s lead candidate, JANX007, is being investigated in a phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a TRACTr that targets PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors, and a validated target for treating mCRPC. Similarly, JANX008 is a TRACTr that targets EGFR and is being studied in a phase 1 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’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. 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. 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 next-generation bispecific immunotherapies with the goal of fighting cancers by killing tumor cells while allowing healthy tissues to remain unharmed. Janux’s proprietary platforms develop unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr) and support the building of a broad pipeline of drugs designed to direct and guide the patient’s immune system to eradicate tumors while minimizing safety concerns. The company's innovative technology currently focuses on the engineering of bispecific antibodies functional only in the tumor, providing safety advantages compared to earlier generations of bispecific immunotherapies. 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 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, the expected timing for announcing interim clinical updates 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	2022		2021
Current assets:
Cash and cash equivalents	$	51,426	$	35,582
Short-term investments		275,590		339,383
Prepaid expenses and other current assets		5,423		2,054
Total current assets		332,439		377,019
Restricted cash		816		816
Property and equipment, net		7,086		1,412
Operating lease right-of-use assets		22,279		185
Other long-term assets		1,390		392
Total assets	$	364,010	$	379,824
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,159	$	2,458
Accrued liabilities		8,010		3,779
Current portion of deferred revenue		5,406		5,163
Unvested stock liabilities		169		1,203
Current portion of operating lease liabilities		763		194
Total current liabilities		16,507		12,797
Deferred revenue, net of current portion		2,221		700
Operating lease liabilities, net of current portion		24,542		—
Total liabilities		43,270		13,497
Total stockholders’ equity		320,740		366,327
Total liabilities and stockholders’ equity	$	364,010	$	379,824

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,
	2022			2021			2022			2021
Collaboration revenue	$	2,845		$	1,616		$	8,612		$	3,637
Operating expenses:
Research and development		15,434			11,169			53,441			26,237
General and administrative		5,677			3,937			22,262			10,329
Total operating expenses		21,111			15,106			75,703			36,566
Loss from operations		(18,266	)		(13,490	)		(67,091	)		(32,929	)
Total other income		2,201			74			4,032			257
Net loss	$	(16,065	)	$	(13,416	)	$	(63,059	)	$	(32,672	)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities, net		742			(294	)		(1,265	)		(270	)
Comprehensive loss	$	(15,323	)	$	(13,710	)	$	(64,324	)	$	(32,942	)
Net loss per common share, basic and diluted	$	(0.39	)	$	(0.33	)	$	(1.52	)	$	(1.39	)
Weighted-average shares of common stock outstanding, basic and diluted		41,584,195			41,208,323			41,469,631			23,530,252

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