Janux Therapeutics Announces Development Candidate Nomination Under Bristol Myers Squibb Collaboration, Triggering $35 Million Milestone Payment

Key Terms

development candidate medical

A development candidate is the specific drug or therapy chosen after early research to advance into formal development and human testing. Think of it as the prototype selected for production after initial experiments, with enough data on how well it works, its safety, and whether it can be made reliably to justify costly clinical trials. Investors watch this milestone because it meaningfully reduces scientific risk and sets the likely timeline, budget, and regulatory path toward possible approval and future sales.

ind-enabling studies regulatory

Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.

ind submission regulatory

An IND submission is an application a drug developer files with a regulatory authority (for example, the U.S. Food and Drug Administration) asking permission to start testing a new medicine in humans. It shows the company’s lab and safety data and a plan for clinical studies; for investors, an accepted IND is like a green light to move from research to trials, reducing development risk and unlocking value milestones.

phase 1 clinical study medical

A phase 1 clinical study is the first stage of testing a new drug or therapy in people to check safety, how the body handles the treatment, and appropriate dosing. Think of it as a cautious test drive with a small group to confirm the product won’t cause serious harm and to gather early clues about whether it might work; for investors, positive phase 1 results reduce risk, guide development timelines and costs, and make later-stage value more tangible.

tiered royalties financial

Tiered royalties are a payment structure where the percentage of earnings paid as royalties changes based on different levels of sales or production. For example, a company might pay a smaller percentage on initial sales and a higher percentage as sales increase beyond certain points. This system encourages higher sales by adjusting payments, making it important for investors to understand how revenue sharing may vary as a product or project grows.

SAN DIEGO--(BUSINESS WIRE)-- Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today announced the nomination of a development candidate under its collaboration and exclusive worldwide license agreement with Bristol Myers Squibb. The milestone was achieved following the identification of a tumor-activated therapeutic, utilizing Janux’s TRACTr platform, targeting an undisclosed solid tumor antigen expressed across several human cancer types, triggering a $35 million milestone payment to Janux.

“This milestone underscores the strength of our approach to generating value through both internal innovation and strategic partnerships, and reflects the continued promise of our tumor-activated platforms,” said David Campbell, Ph.D., President and Chief Executive Officer of Janux. “The nomination of a development candidate highlights our ability to translate platform insights into differentiated therapeutics in collaboration with leading oncology companies.”

“We are pleased to reach this important milestone with Bristol Myers Squibb, which reflects strong collaboration between our teams and the disciplined execution of our research and development efforts,” said Janeen Doyle, Chief Corporate and Business Development Officer of Janux. “Advancing a program to development candidate nomination represents a key step toward IND-enabling studies and clinical development.”

Under the terms of the collaboration agreement, Janux is responsible for conducting preclinical development through IND submission. Bristol Myers Squibb will hold the IND and will be responsible for subsequent clinical development and global commercialization of products arising from the collaboration. Janux will remain actively involved in the program, supporting Bristol Myers Squibb through completion of the first Phase 1 clinical study.

In addition to the $35 million milestone payment associated with development candidate nomination, Janux is eligible to receive additional development, regulatory and commercial milestone payments, as well as tiered royalties on global product sales.

About Janux Therapeutics

Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. 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 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 tumors. Janux is also advancing its first ARM platform clinical candidate, JANX011, a CD19-ARM for the potential treatment of autoimmune diseases in a Phase 1 study in healthy adult volunteers. Janux continues to generate a number of additional TRACTr, TRACIr, and ARM programs for potential future development. 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 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 potential milestone and royalty payments and development activities under the collaboration agreement with Bristol Myers Squibb. Factors that may cause actual results to differ materially include the risk that interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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, the fact that Janux has limited control over the efforts and resources that its collaborators devote to advancing development and commercialization of licensed compounds and/or licensed products and the risk that Janux may not receive the potential payments under its collaboration agreements or fully realize the benefits of such collaborations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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Investors:
Chad Rubin
Endurance Advisors
crubin@enduranceadvisors.com
646.319.3261

Media:
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
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858.344.8091

Source: Janux Therapeutics