Janux Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights

Rhea-AI Summary

Janux Therapeutics, Inc. (JANX) Reports Enrollment Ongoing for PSMA-TRACTr (JANX007) in Prostate Cancer and EGFR-TRACTr (JANX008) in Solid Tumors, Expects Update on Clinical Programs in 2024 with $349.7 Million in Cash and Investments at End of Q3 2023

Positive

• Janux continues to make progress in its clinical trials for JANX007 and JANX008, demonstrating commitment to advancing its pipeline of immunotherapies. The company's strong financial foundation and projected cash and investments through 2027 provide stability and support for its current operating plan and future milestones.

Negative

• None.

• Enrollment ongoing for PSMA-TRACTr (JANX007) in prostate cancer
• Enrollment ongoing for EGFR-TRACTr (JANX008) in solid tumors
• Update on clinical programs expected in 2024
• $349.7 million in cash, cash equivalents, and short-term investments at end of third quarter 2023
• Cash and investments projected to support current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs

SAN DIEGO--(BUSINESS WIRE)-- 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, 2023, and provided a business update.

“We are pleased with the enrollment in the two clinical studies for our PSMA-TRACTr JANX007 and our EGFR-TRACTr JANX008,” said David Campbell, Ph.D., President and CEO of Janux. “As we enter 2024, equipped with a strong financial foundation, we are committed to advancing these clinical programs and expanding our pipeline so that we can rapidly bring forward new meaningful therapies for cancer patients.”

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

• PSMA-TRACTr (JANX007) continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).
• EGFR-TRACTr (JANX008) continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).
• PD-L1xCD28 TRACIr (JANX009) IND-enabling studies completed.
• TROP2-TRACTr development candidate identification completed.

Janux anticipates providing an update on its clinical programs in 2024.

THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS:

• Cash and cash equivalents and short-term investments: As of September 30, 2023, Janux reported cash and cash equivalents and short-term investments of $349.7 million compared to $327.0 million at December 31, 2022, which we project will be sufficient to fund our current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs.
• Research and development expenses: For the quarter ended September 30, 2023, Janux reported research and development expenses of $11.9 million compared to $13.7 million for the comparable period in 2022.
• General and administrative expenses: For the quarter ended September 30, 2023, Janux reported general and administrative expenses of $6.4 million compared to $6.1 million for the comparable period in 2022.
• Net loss: For the quarter ended September 30, 2023, Janux reported a net loss of $11.6 million compared to $16.7 million for the comparable period in 2022.

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 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.

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)
		September 30, 2023				December 31, 2022
Assets		(unaudited)
Current assets:
Cash and cash equivalents		$	17,152			$	51,426
Short-term investments			332,560				275,590
Prepaid expenses and other current assets			5,483				5,423
Total current assets			355,195				332,439
Restricted cash			816				816
Property and equipment, net			7,317				7,086
Operating lease right-of-use assets			21,208				22,279
Other long-term assets			2,314				1,390
Total assets		$	386,850			$	364,010
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	2,505			$	2,159
Accrued liabilities			6,831				8,010
Current portion of deferred revenue			3,648				5,406
Unvested stock liabilities			25				169
Current portion of operating lease liabilities			1,462				763
Total current liabilities			14,471				16,507
Deferred revenue, net of current portion			—				2,221
Operating lease liabilities, net of current portion			23,431				24,542
Total liabilities			37,902				43,270
Total stockholders’ equity			348,948				320,740
Total liabilities and stockholders’ equity		$	386,850			$	364,010

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,
		2023				2022				2023				2022
Collaboration revenue		$	2,517			$	1,813			$	5,622			$	5,767
Operating expenses:
Research and development			11,892				13,737				42,681				38,007
General and administrative			6,438				6,098				19,783				16,585
Total operating expenses			18,330				19,835				62,464				54,592
Loss from operations			(15,813	)			(18,022	)			(56,842	)			(48,825	)
Total other income			4,245				1,326				10,307				1,831
Net loss		$	(11,568	)		$	(16,696	)		$	(46,535	)		$	(46,994	)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities, net			(115	)			(370	)			360				(2,007	)
Comprehensive loss		$	(11,683	)		$	(17,066	)		$	(46,175	)		$	(49,001	)
Net loss per common share, basic and diluted		$	(0.25	)		$	(0.40	)		$	(1.08	)		$	(1.13	)
Weighted-average shares of common stock outstanding, basic and diluted			45,708,649				41,526,524				43,117,403				41,431,023

 

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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

Source: Janux Therapeutics

FAQ

What are Janux Therapeutics' clinical programs?

Janux is currently enrolling patients for its PSMA-TRACTr (JANX007) in prostate cancer and EGFR-TRACTr (JANX008) in solid tumors, with an update on clinical programs expected in 2024.

What is Janux Therapeutics' financial status?

As of September 30, 2023, Janux reported $349.7 million in cash, cash equivalents, and short-term investments, projected to support the current operating plan through 2027.

What is Janux Therapeutics' focus in drug development?

Janux is focused on developing a broad pipeline of novel immunotherapies using its proprietary technology to target various cancer types, including prostate, colorectal, lung, and head and neck cancers.

What is the status of Janux Therapeutics' clinical trials?

Enrollment is ongoing for PSMA-TRACTr (JANX007) in prostate cancer and EGFR-TRACTr (JANX008) in solid tumors, with an update on clinical programs expected in 2024.

What is the financial outlook for Janux Therapeutics?

With $349.7 million in cash and investments at the end of Q3 2023, Janux projects support for its current operating plan through 2027 to generate Phase 1b data for its PSMA and EGFR-TRACTr programs.