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): May 10, 2022

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.)
11099 N. Torrey Pines Road, Suite 290<br><br>La Jolla, California		92037
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 750-4700

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

EX-99.1

Exhibit 99.1

Janux Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights

-IND application recently submitted for PSMA-TRACTr (JANX007)-

-Company remains on-track to submit IND application for EGFR-TRACTr (JANX008) in 2H 2022-

-Merck nominates second target as part of strategic collaboration and license agreement-

-Presented preclinical data for JANX007 and JANX008 at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston Conference & Expo-

-$361.2 million in cash and cash equivalents and short-term investments at end of first quarter 2022-

SAN DIEGO, May 10, 2022 – Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a 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 first quarter ended March 31, 2022 and provided a business update.

“Janux continues to make meaningful progress towards our goal of developing next-generation immunotherapies that are uniquely designed to overcome the clinical limitations of existing TCE approaches,” said David Campbell, Ph.D., President and CEO of Janux. “Recently, we were pleased to have presented compelling preclinical data supporting the planned clinical development of both our lead TRACTr programs at PEGS Boston, and we are excited about our progress in advancing IND application submissions for JANX007 and JANX008 in 2022. In tandem, we continue to advance our TROP2-TRACTr and our PD-L1xCD28 costimulatory TRACIr programs, with the goal of submitting an IND for both in 2023. We look forward to driving our pipeline of next-generation immunotherapies into the clinic and executing on our near-term milestones.”

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

• TRACTr candidates advancing as planned.

o Janux recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its PSMA-TRACTr (JANX007). cGMP manufacturing of drug substance and drug product has been completed to support the IND and supply first-in-human (FIH) clinical studies.

o Janux expects to submit an IND application to the FDA for its EGFR-TRACTr (JANX008) in the second half of 2022. cGMP manufacturing of drug substance has been completed to support the IND and supply FIH clinical studies.

o Janux expects to submit an IND application to the FDA for its TROP2-TRACTr in 2023.

• Merck nominates second target as part of strategic collaboration and license agreement. In May 2022, Merck nominated a second target under the 2020 Research Collaboration and Exclusive License Agreement between Merck and Janux.

• Presented preclinical data for JANX007 and JANX008 from the Company’s TRACTr platform at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston. In May 2022, Janux presented preclinical data for the Company’s two lead TRACTr programs at PEGS Boston. JANX007 is a novel TRACTr therapeutic targeting prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer, and JANX008 is a novel TRACTr therapeutic targeting epidermal growth factor receptor (EGFR) for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, and non-small cell lung cancer.

o Data presented showed that JANX007 and JANX008 exhibited enhanced safety and pharmacokinetic properties relative to unmasked T cell engagers (TCE). Both candidates were well tolerated in non-human primate safety studies with limited healthy tissue toxicities and cytokine release syndrome. These data demonstrate key characteristics of JANX007 and JANX008 which support their planned clinical development.

• IND-enabling studies ongoing for first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors.

o Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023. Janux has initiated cGMP manufacturing activities to support production and release of drug substance and drug product.

FIRST QUARTER 2022 FINANCIAL HIGHLIGHTS:

• Cash and cash equivalents and short-term investments: As of March 31, 2022, Janux reported cash and cash equivalents and short-term investments of $361.2 million, compared to $375.0 million at December 31, 2021.

• Research and development expenses: Research and development expenses for the quarter ended March 31, 2022 were $10.2 million, compared to $1.9 million for the comparable period in 2021.

• General and administrative expenses: General and administrative expenses for the quarter ended March 31, 2022 were $4.9 million, compared to $0.7 million for the comparable period in 2021.

• Net loss: For the quarter ended March 31, 2022, Janux reported a net loss of $13.4 million, compared to a net loss of $2.3 million for the comparable period in 2021.

About Janux Therapeutics

Janux Therapeutics is an innovative biopharmaceutical company developing next-generation therapeutics based on applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to better treat patients suffering from cancer. Janux’s initial focus is on developing a novel class of T cell engagers (TCEs), and its lead product candidates are designed to target clinically validated drug targets. While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors have faced challenges due to the limitations of prior TCE technologies, namely (i) overactivation of the immune system leading to cytokine release syndrome, (ii) on-target, healthy tissue toxicities, and (iii) poor pharmacokinetics leading to short half-life. Janux is using its TRACTr platform technology to engineer

product candidates designed to overcome these limitations by offering accuracy, stability, activity, modularity, and manufacturability. Janux is developing a broad pipeline with lead TRACTr programs targeting prostate-specific membrane antigen (PSMA), epidermal growth factor receptor (EGFR), and trophoblast cell surface antigen 2 (TROP2), and its lead TRACIr program targeting PD-L1xCD28, with all of its programs currently in the IND-enabling or discovery stage. For more information, please visit www.januxrx.com.

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, the progress and expected timing of Janux’s drug development programs, 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.

Contacts

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

(858) 344-8091

Investors:

Christina Tartaglia

Stern Investor Relations, Inc.

christina@sternir.com

(212) 362-1200

Janux Therapeutics, Inc.

Condensed Balance Sheets

(in thousands)

	March 31,<br>2022		December 31,<br>2021
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	55,129	$	35,582
Short-term investments		306,071		339,383
Prepaid expenses and other current assets		3,454		2,054
Total current assets		364,654		377,019
Restricted cash		816		816
Property and equipment, net		2,660		1,412
Operating lease right-of-use assets		130		185
Other long-term assets		337		392
Total assets	$	368,597	$	379,824
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,939	$	2,458
Accrued liabilities		5,074		3,779
Current portion of deferred revenue		4,649		5,163
Unvested stock liabilities		700		1,203
Current portion of operating lease liabilities		153		194
Total current liabilities		12,515		12,797
Deferred revenue, net of current portion		—		700
Total liabilities		12,515		13,497
Total stockholders’ equity		356,082		366,327
Total liabilities and stockholders’ equity	$	368,597	$	379,824

Janux Therapeutics, Inc.

Unaudited Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

	Three Months Ended<br> March 31,
	2022			2021
Collaboration revenue	$	1,589		$	380
Operating expenses:
Research and development		10,184			1,925
General and administrative		4,947			739
Total operating expenses		15,131			2,664
Loss from operations		(13,542	)		(2,284	)
Total other income		132			—
Net loss	$	(13,410	)	$	(2,284	)
Other comprehensive loss:
Unrealized loss on available-for-sale securities, net		(1,567	)		—
Comprehensive loss	$	(14,977	)	$	(2,284	)
Net loss per common share, basic and diluted	$	(0.32	)	$	(2.06	)
Weighted-average shares of common stock outstanding, basic and diluted		41,315,482			1,111,178