Janux Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights

Rhea-AI Summary

Janux Therapeutics (NASDAQ: JANX) reported its Q4 and full year 2024 financial results, highlighting significant clinical progress and strong financial position. The company presented positive Phase 1 trial data for PSMA-TRACTr JANX007 in prostate cancer, showing impressive results including 100% PSA50 decline rates and 50% objective response rate in treated patients.

Financial highlights include $1.03 billion in cash and investments as of December 31, 2024, bolstered by a $402.5 million capital raise in December 2024. The company reported increased R&D expenses of $68.4 million and G&A expenses of $41.0 million for 2024, with a net loss of $69.0 million.

Clinical progress continues with ongoing enrollment for both JANX007 and JANX008 trials, with updates anticipated in 2025 along with an R&D Day to discuss new programs.

Positive

• Strong clinical efficacy: 100% PSA50 response rate in JANX007 trial
• Robust cash position of $1.03B following $402.5M capital raise
• 50% objective response rate in JANX007 Phase 1 trial
• Well-tolerated safety profile for JANX007

Negative

• Increased net loss to $69.0M in 2024 from $58.3M in 2023
• Higher R&D expenses at $68.4M vs $54.9M previous year
• G&A expenses increased to $41.0M from $26.1M year-over-year

Insights

Financial Analyst

Janux Therapeutics reported exceptional financial positioning and promising clinical data in its Q4 and full-year 2024 results. The company's $1.03 billion cash position (compared to $344 million at end-2023) represents over 50% of its current market capitalization, providing a remarkable runway of approximately 11+ years at current expense levels. This financial strength follows a successful $402.5 million capital raise in December, eliminating near-term financing risk and enabling aggressive advancement of multiple clinical programs.

The clinical data for PSMA-targeted JANX007 in metastatic castration-resistant prostate cancer is particularly impressive. The 100% PSA50 response rate (with 63% achieving PSA90) significantly exceeds typical response rates seen in heavily pretreated mCRPC patients. The 50% objective response rate and 63% disease control rate demonstrate meaningful anti-tumor activity. Importantly, the safety profile appears manageable, with cytokine release syndrome primarily to cycle 1 and lower grades - a critical differentiator from earlier generation T cell engagers that were often by severe toxicities.

Increasing operational expenses reflect appropriate investment in clinical advancement rather than concerning cash burn. R&D expenses rose to $68.4 million for 2024 (vs. $54.9 million in 2023), while G&A expenses increased to $41.0 million (vs. $26.1 million). The promotion of Dr. McIver to CMO brings valuable Amgen executive experience to lead clinical execution during this pivotal growth phase.

Investors should focus on the upcoming data updates for both JANX007 and JANX008 in 2025, particularly looking for durability of responses, expansion into earlier treatment lines, and comparative efficacy against other PSMA-targeted therapies like Pluvicto. The planned R&D Day will provide critical insights into new pipeline assets that could further expand Janux's value proposition beyond its current clinical-stage programs.

Oncology Expert

The clinical data for JANX007 demonstrates exceptional activity in metastatic castration-resistant prostate cancer (mCRPC), a setting where treatment options are and prognosis is poor. The 100% PSA50 response rate substantially outperforms current standard-of-care therapies like Zytiga and Xtandi (typically 30-50% PSA50 in earlier treatment lines) and even exceeds the performance of recently approved PSMA-targeted radiopharmaceutical Pluvicto (~30% ORR). The 50% objective response rate is particularly impressive in late-line mCRPC where response rates typically range from 5-20%.

The durability data is clinically meaningful, with 75% of patients maintaining PSA50 declines at ≥12 weeks. While PSA is a surrogate marker, sustained PSA declines correlate with improved survival outcomes in mCRPC. The depth of PSA response is also noteworthy, with 31% achieving PSA99 declines, suggesting potential for deep and meaningful tumor suppression.

The manageable safety profile addresses a critical limitation of T cell engagers, which historically struggle with severe cytokine release syndrome and neurotoxicity. By restricting activation to the tumor microenvironment through the TRACTr platform, JANX007 appears to mitigate the on-target/off-tumor toxicity that has previous PSMA-directed therapies.

PSMA expression increases with disease progression and after androgen deprivation therapy, making it an ideal target for late-stage disease. However, the impressive efficacy and safety profile suggest potential for moving to earlier treatment lines, which would significantly expand the addressable patient population and potentially improve outcomes when used before resistance mechanisms develop.

The EGFR-targeting JANX008 program represents another significant opportunity, as EGFR is expressed across multiple tumor types but has been challenging to target with T cell engagers due to normal tissue expression. If the TRACTr platform can successfully address this limitation, it could enable effective targeting of this validated oncogenic driver across numerous high-incidence cancers including colorectal, head and neck, and lung cancers.

• Recently presented positive Phase 1 clinical trial data for PSMA-TRACTr JANX007 in mCRPC
• Enrollment ongoing for JANX007 and JANX008
• Update on JANX007 and JANX008 data is anticipated in 2025
• R&D Day is anticipated in 2025 to disclose new programs moving toward the clinic
• $1.03 billion in year-end cash, cash equivalents, and short-term investments

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 fourth quarter and full year ended December 31, 2024, and provided a business update.

“2024 was an exceptional year for Janux as we displayed the potential power of our TRACTr platform in the clinic. We believe the data recently presented from JANX007 demonstrated substantial clinical activity in late line mCRPC patients, supporting our future clinical development plans directed at earlier line patients. With our substantial cash runway, we feel well-positioned to execute on our clinical plans, as well as bring new programs towards the clinic that could provide substantial value to both Janux, and more importantly, the patients we serve,” said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

• Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in December 2024. As of the November 15, 2024, data cutoff in 16 patients JANX007 displayed:
  • High prostate-specific antigen (PSA) response rates: 100% achieved best PSA50 declines.
  • Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines.
  • Durable PSA declines maintained at ≥ 12 weeks: 75% maintained PSA 50 declines; 50% maintained PSA90 declines.
  • Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8) (including confirmed and unconfirmed).
  • Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and lower grades.
• Gross proceeds of approximately $402.5 million (before deducting underwriting discounts and commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in December 2024.
• Janux to host R&D Day in 2025.
  • Janux plans to provide an update on pipeline programs selected for clinical development.
• JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).
• JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).
• Zachariah McIver, D.O., Ph.D. promoted to Chief Medical Officer. Dr. McIver has been instrumental in executing on Janux’s clinical programs. Dr. McIver continues to lead cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies. An accomplished physician-scientist with over 15-years of experience in clinical research, Dr. McIver joined Janux after serving as Amgen’s Executive Medical Director for over 4 years.

An update on JANX007 and JANX008 data is anticipated in 2025. Janux will also be hosting an R&D Day in 2025.

FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS:

• Cash and cash equivalents and short-term investments: As of December 31, 2024, Janux reported cash and cash equivalents and short-term investments of $1.03 billion compared to $344.0 million at December 31, 2023.
• Research and development expenses: Research and development expenses were $20.8 million for the quarter and $68.4 million for the year ended December 31, 2024, compared to $12.2 million and $54.9 million for the same quarter and year in 2023.
• General and administrative expenses: General and administrative expenses were $8.2 million for the quarter and $41.0 million for the year ended December 31, 2024, compared to $6.4 million and $26.1 million for the same quarter and year in 2023.
• Net loss: Net loss was $20.2 million for the quarter and $69.0 million for the year ended December 31, 2024, compared to $11.8 million and $58.3 million for the same quarter and year in 2023.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (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: TRACTr and 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.

Janux Therapeutics, Inc. Condensed Balance Sheets (in thousands)
		December 31,
Assets		2024				2023
Current assets:
Cash and cash equivalents		$	430,605			$	19,205
Short-term investments			594,568				324,823
Prepaid expenses and other current assets			8,493				5,213
Total current assets			1,033,666				349,241
Restricted cash			816				816
Property and equipment, net			4,864				7,003
Operating lease right-of-use assets			19,286				20,838
Other long-term assets			2,884				2,509
Total assets		$	1,061,516			$	380,407
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,026			$	2,424
Accrued expenses			11,684				7,387
Current portion of deferred revenue			—				1,705
Current portion of operating lease liabilities			1,749				1,517
Total current liabilities			17,459				13,033
Operating lease liabilities, net of current portion			21,276				23,025
Total liabilities			38,735				36,058
Total stockholders’ equity			1,022,781				344,349
Total liabilities and stockholders’ equity		$	1,061,516			$	380,407

Janux Therapeutics, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data)
		Three Months Ended December 31,								Year Ended December 31,
		2024				2023				2024				2023
Collaboration revenue		$	—			$	2,461			$	10,588			$	8,083
Operating expenses:
Research and development			20,806				12,241				68,388				54,922
General and administrative			8,216				6,357				41,047				26,140
Total operating expenses			29,022				18,598				109,435				81,062
Loss from operations			(29,022	)			(16,137	)			(98,847	)			(72,979	)
Total other income			8,806				4,379				29,853				14,686
Net loss		$	(20,216	)		$	(11,758	)		$	(68,994	)		$	(58,293	)
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities, net			(5,668	)			1,840				1,498				2,200
Comprehensive loss		$	(25,884	)		$	(9,918	)		$	(67,496	)		$	(56,093	)
Net loss per common share, basic and diluted		$	(0.36	)		$	(0.25	)		$	(1.28	)		$	(1.32	)
Weighted-average shares of common stock outstanding, basic and diluted			56,832,374				46,683,613				53,751,480				44,016,283

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250227733415/en/

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 were the key clinical results for JANX007 in the Phase 1 trial for prostate cancer?

JANX007 showed 100% PSA50 decline rates, 63% PSA90 declines, and 50% objective response rate in mCRPC patients, with a well-tolerated safety profile.

How much cash does JANX have following its December 2024 offering?

Janux reported $1.03 billion in cash, cash equivalents, and short-term investments as of December 31, 2024.

What was Janux Therapeutics' net loss for full-year 2024?

Janux reported a net loss of $69.0 million for the year ended December 31, 2024.

When will Janux provide updates on JANX007 and JANX008 clinical trials?

Updates on both JANX007 and JANX008 clinical trials are anticipated in 2025.