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What changed in Janux Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Janux Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+646 added−628 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-27)

Top changes in Janux Therapeutics, Inc.'s 2025 10-K

646 paragraphs added · 628 removed · 448 edited across 3 sections

Item 1. Business

Business — how the company describes what it does

272 edited+162 added−145 removed929 unchanged
Biggest changeIf a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other foreign regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other foreign regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. 53 Table of Contents We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Biggest changeWe may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
This toxicity severely restricts the maximum blood levels of TCEs that can be safely dosed. • On-target, healthy tissue toxicity. On-target, healthy tissue toxicity, arising from expression of the tumor target in healthy tissue and scarcity of highly tumor-selective antigens, is another limitation hindering the development of TCEs to treat solid tumor cancers.
This toxicity severely restricts the maximum blood levels of TCEs that can be safely dosed. • On-target, healthy tissue toxicity. On-target, healthy tissue toxicity, arising from the expression of the tumor target in healthy tissue and scarcity of highly tumor-selective antigens, is another limitation hindering the development of TCEs to treat solid tumor cancers.
On-target, healthy tissue toxicity, arising from the expression of the tumor target in healthy tissue and scarcity of highly tumor-selective antigens, is another limitation hindering the development of TCEs to treat solid tumor cancers.
On-target, healthy tissue toxicity, arising from expression of the tumor target in healthy tissue and scarcity of highly tumor-selective antigens, is another limitation hindering the development of TCEs to treat solid tumor cancers.
TCEs developed using other platforms not designed for tumor-specific activation have resulted in clinical holds and dose-limiting toxicities resulting from target expression in healthy tissues. • Short half-lives. TCEs quickly reach sub-therapeutic levels after being administered as they are quickly eliminated from the body due to their short exposure half-lives.
TCEs developed using other platforms not designed for tumor-specific activation have resulted in clinical holds and dose-limiting toxicities resulting from target expression in healthy tissues. • Short half-lives. TCEs quickly reach sub-therapeutic levels after being administered as they are quickly eliminated from the body due to their short exposure half-lives.
We designed our TRACTrs and TRACIrs with an albumin-binding domain to be stable in the bloodstream and to have an extended serum half-life before activation. Our TRACTrs and TRACIrs have demonstrated long half-lives in NHPs.
We designed our TRACTrs and TRACIrs with an albumin-binding domain to be stable in the bloodstream and to have an extended serum half-life before activation. Our TRACTrs and TRACIrs have demonstrated long half-lives in NHPs.
In preclinical studies, our TRACTrs and TRACIrs did not require high levels of tumor target expression to activate T cells to kill cancer cells. • Modularity.
In preclinical studies, our TRACTrs and TRACIrs did not require high levels of tumor target expression to activate T cells to kill cancer cells. • Modularity.
Our TRACTr and TRACIr platforms’ modular characteristics enable us to leverage the learnings from the development of our product candidates to progress the discovery process of new TRACTr and TRACIr candidates against a wide variety of targets. • Manufacturability.
Our TRACTr and TRACIr platforms’ modular characteristics enable us to leverage the learnings from the development of our product candidates to progress the discovery process of new TRACTr and TRACIr candidates against a wide variety of targets. • Manufacturability.
Our product candidates may be used in combination with other cancer drugs, such as other immuno-oncology agents, monoclonal antibodies or other protein-based drugs or small molecule anti-cancer agents such as targeted agents or chemotherapy, which can cause side effects or adverse events that are unrelated to our product candidate but may still impact the success of our clinical trials.
Our product candidates may be used in combination with other drugs, such as other immuno-oncology agents, monoclonal antibodies or other protein-based drugs or small molecule anti-cancer agents such as targeted agents or chemotherapy, which can cause side effects or adverse events that are unrelated to our product candidate but may still impact the success of our clinical trials.
The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects.
The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects.
The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, and convenience. If we are not successful in developing, commercializing and achieving higher levels of reimbursement than our competitors, we will not be able to compete against them and our business would be materially harmed.
The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, and convenience. If we are not successful in developing, commercializing and achieving higher levels of reimbursement than our competitors, we will not be able to compete against them and our business would be materially harmed.
For example: • others may be able to make product candidates that are similar to ours but that are not covered by the claims of the patents that we own or may exclusively license; • we or licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or licensors or collaborators might not have been the first to file patent applications covering certain aspects of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; 76 Table of Contents • it is possible that noncompliance with the USPTO and foreign governmental patent agencies requirement for a number of procedural, documentary, fee payment and other provisions during the patent process can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or have exclusively licensed may be revoked, modified, or held invalid or unenforceable, as a result of legal challenges by our competitors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; • we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that directed to our product candidates or uses thereof in the United States or in other foreign countries; • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; • countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates; • the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; • if enforced, a court may not hold that our patents are valid, enforceable and infringed; • we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose; • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent application covering such intellectual property; • we may fail to adequately protect and police our trademarks and trade secrets; and • the patents of others may have an adverse effect on our business, including if others obtain patents claiming subject matter similar to or improving that covered by our patents and patent applications.
For example: • others may be able to make product candidates that are similar to ours but that are not covered by the claims of the patents that we own or may exclusively license; • we or licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or licensors or collaborators might not have been the first to file patent applications covering certain aspects of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • it is possible that noncompliance with the USPTO and foreign governmental patent agencies requirement for a number of procedural, documentary, fee payment and other provisions during the patent process can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or have exclusively licensed may be revoked, modified, or held invalid or unenforceable, as a result of legal challenges by our competitors; 78 Table of Contents • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; • we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that directed to our product candidates or uses thereof in the United States or in other foreign countries; • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; • countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates; • the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; • if enforced, a court may not hold that our patents are valid, enforceable and infringed; • we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose; • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent application covering such intellectual property; • we may fail to adequately protect and police our trademarks and trade secrets; and • the patents of others may have an adverse effect on our business, including if others obtain patents claiming subject matter similar to or improving that covered by our patents and patent applications.
The FDA, the EMA, the European Commission or other comparable foreign regulatory authorities can delay, limit or deny approval of our product candidates or require us to conduct additional nonclinical or clinical testing or abandon a program for many reasons, including: • the FDA, the EMA or comparable foreign regulatory authorities’ disagreement with the design or implementation of our ongoing or planned clinical trials; • negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA, the EMA or comparable foreign regulatory authorities for approval; • serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates; • our inability to demonstrate to the satisfaction of the FDA, the EMA or comparable foreign regulatory authorities that our product candidates are safe and effective for the proposed indication; • the FDA’s, the EMA’s, or comparable foreign regulatory authorities’ disagreement with the interpretation of data from nonclinical studies or clinical trials; • our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks; • the FDA’s, the EMA’s or a comparable foreign regulatory authorities’ requirement for additional nonclinical studies or clinical trials; • the FDA’s, the EMA’s or comparable foreign regulatory authorities' disagreement regarding the formulation, labeling and/or the specifications of our product candidates; • the FDA’s or comparable foreign regulatory authorities’ failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or 51 Table of Contents • the potential for approval policies or regulations of the FDA, the European Commission or comparable foreign regulatory authorities’ to significantly change in a manner rendering our clinical data insufficient for approval.
The FDA, the EMA, the European Commission or other comparable foreign regulatory authorities can delay, limit or deny approval of our product candidates or require us to conduct additional nonclinical or clinical testing or abandon a program for many reasons, including: • the FDA, the EMA or comparable foreign regulatory authorities’ disagreement with the design or implementation of our ongoing or planned clinical trials; • negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA, the EMA or comparable foreign regulatory authorities for approval; • serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates; • our inability to demonstrate to the satisfaction of the FDA, the EMA or comparable foreign regulatory authorities that our product candidates are safe and effective for the proposed indication; • the FDA’s, the EMA’s, or comparable foreign regulatory authorities’ disagreement with the interpretation of data from nonclinical studies or clinical trials; • our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks; • the FDA’s, the EMA’s or a comparable foreign regulatory authorities’ requirement for additional nonclinical studies or clinical trials; • the FDA’s, the EMA’s or comparable foreign regulatory authorities' disagreement regarding the formulation, labeling and/or the specifications of our product candidates; • the FDA’s or comparable foreign regulatory authorities’ failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or 52 Table of Contents • the potential for approval policies or regulations of the FDA, the European Commission or comparable foreign regulatory authorities’ to significantly change in a manner rendering our clinical data insufficient for approval.
CRS arises from the systemic activation of T cells and can result in life-threatening elevations in inflammatory cytokines such as interleukin-6 (IL-6). Severe and acute CRS leading to dose-limiting toxicities and deaths has been observed upon the dosing of TCEs developed using other platforms to treat cancer patients in prior clinical studies.
CRS arises from the systemic activation of T cells and can result in life-threatening elevations in inflammatory cytokines such as IL-6. Severe and acute CRS leading to dose-limiting toxicities and deaths has been observed upon the dosing of TCEs developed using other platforms to treat cancer patients in prior clinical studies.
The extent to which a resurgence of a health epidemic or pandemic or other health crises may impede the development of our product candidates, reduce the productivity of our employees, disrupt our supply chains, delay our clinical trials, reduce our access to capital or limit our business development activities, will depend on future developments, which are highly uncertain and cannot be predicted with confidence and may also have the effect of heightening many of the other risks described in this “Risk Factors” section. 67 Table of Contents Risks Related to Government Regulation Our business operations and current and future relationships with investigators, health care professionals, consultants, third-party payors and customers are subject, directly or indirectly, to U.S. federal and state, EU, or foreign jurisdictions’ healthcare fraud and abuse laws, transparency laws and other healthcare laws and regulations.
The extent to which a resurgence of a health epidemic or pandemic or other health crises may impede the development of our product candidates, reduce the productivity of our employees, disrupt our supply chains, delay our clinical trials, reduce our access to capital or limit our business development activities, will depend on future developments, which are highly uncertain and cannot be predicted with confidence and may also have the effect of heightening many of the other risks described in this “Risk Factors” section. 69 Table of Contents Risks Related to Government Regulation Our business operations and current and future relationships with investigators, health care professionals, consultants, third-party payors and customers are subject, directly or indirectly, to U.S. federal and state, EU, or foreign jurisdictions’ healthcare fraud and abuse laws, transparency laws and other healthcare laws and regulations.
The process generally involves the following: • completion of extensive preclinical laboratory and animal studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice (GLP) requirements; • submission to the FDA of an investigational new drug application (IND), which must become effective before human clinical trials may begin; • approval by an institutional review board (IRB) or independent ethics committee at each clinical trial site before each clinical trial may be commenced; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice (GCP) requirements and other regulations to establish the safety and efficacy of the investigational product for each proposed indication; • submission to the FDA of a BLA; • payment of any user fees for FDA review of the BLA; • a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review; • satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic, or components thereof, will be produced to assess compliance with current good manufacturing processes (cGMP) requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity; • satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCPs and integrity of the clinical data; • FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee; and • compliance with any post-approval requirements, including REMS, where applicable, and post- approval studies required by the FDA as a condition of approval.
The process generally involves the following: • completion of extensive preclinical laboratory and animal studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice (GLP) requirements; • submission to the FDA of an investigational new drug application (IND), which must become effective before human clinical trials may begin; • approval by an institutional review board (IRB) or independent ethics committee at each clinical trial site before each clinical trial may be commenced; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice (GCP) requirements and other regulations to establish the safety and efficacy of the investigational product for each proposed indication; • submission to the FDA of a BLA; • payment of any user fees for FDA review of the BLA; • a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review; 31 Table of Contents • satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic, or components thereof, will be produced to assess compliance with current good manufacturing processes (cGMP) requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity; • satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCPs and integrity of the clinical data; • FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee; and • compliance with any post-approval requirements, including REMS, where applicable, and post- approval studies required by the FDA as a condition of approval.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine to be material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. 50 Table of Contents If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates, our business, operating results, prospects or financial condition may be harmed.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine to be material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. 51 Table of Contents If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates, our business, operating results, prospects or financial condition may be harmed.
If we are unable to obtain PTE or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product will be shortened and our competitors may obtain approval of competing products following our patent expiration and may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to launch their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially. 84 Table of Contents If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
If we are unable to obtain PTE or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product will be shortened and our competitors may obtain approval of competing products following our patent expiration and may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to launch their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially. 86 Table of Contents If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
These include: • issuing warning or untitled letters; • mandating modifications to promotional materials or require us to provide corrective information to healthcare professionals, or require other restrictions on the labeling or marketing of such products; • seeking an injunction or imposing civil or criminal penalties or monetary fines; • suspension or imposition of restrictions on operations, including product manufacturing; 52 Table of Contents • seizure or detention of products, refusal to permit the import or export of products or request that we initiate a product recall; • suspension, modification or withdrawal of our marketing authorizations; • suspension of any ongoing clinical trials; • refusal to approve pending applications or supplements to applications submitted by us; • refusal to permit the import or export of products; or • requiring us to conduct additional clinical trials, change our product labeling or submit additional applications for marketing authorization.
These include: • issuing warning or untitled letters; • mandating modifications to promotional materials or require us to provide corrective information to healthcare professionals, or require other restrictions on the labeling or marketing of such products; • seeking an injunction or imposing civil or criminal penalties or monetary fines; • suspension or imposition of restrictions on operations, including product manufacturing; 53 Table of Contents • seizure or detention of products, refusal to permit the import or export of products or request that we initiate a product recall; • suspension, modification or withdrawal of our marketing authorizations; • suspension of any ongoing clinical trials; • refusal to approve pending applications or supplements to applications submitted by us; • refusal to permit the import or export of products; or • requiring us to conduct additional clinical trials, change our product labeling or submit additional applications for marketing authorization.
Because of the early stage of development of our products candidates, our ability to eventually generate significant revenues from product sales will depend on a number of factors, including: • completion of additional preclinical studies with favorable results; • acceptance of INDs by the FDA or similar regulatory filing with comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates and our proposed design of future clinical trials; • successful enrollment in, and completion of, clinical trials and achieving positive results from the trials; • demonstrating a risk-benefit profile acceptable to regulatory authorities; • receipt of marketing approvals from applicable regulatory authorities, including biologics license applications (BLAs), from the FDA and equivalent approvals from comparable foreign regulatory authorities and maintaining such approvals; • making arrangements with third-party manufacturers, or establishing manufacturing capabilities for clinical supply and, if and when approved, for commercial supply; • establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in combination with others; • acceptance of our products, if and when approved, by patients, the medical community and third-party payors; • effectively competing with other therapies; • obtaining and maintaining third-party coverage and adequate reimbursement; • obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates; and • maintaining a continued acceptable safety profile of any product following approval, if any.
Because of the early stage of development of our products candidates, our ability to eventually generate significant revenues from product sales will depend on a number of factors, including: • completion of additional preclinical studies with favorable results; • acceptance of INDs by the FDA or similar regulatory filing with comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates and our proposed design of future clinical trials; • successful enrollment in, and completion of, clinical trials and achieving positive results from the trials; • demonstrating a risk-benefit profile acceptable to regulatory authorities; • receipt of marketing approvals from applicable regulatory authorities, including biologics license applications (BLAs), from the FDA and equivalent approvals from comparable foreign regulatory authorities and maintaining such approvals; • making arrangements with third-party manufacturers, or establishing manufacturing capabilities for clinical supply and, if and when approved, for commercial supply; • establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in combination with others; • acceptance of our products, if and when approved, by patients, the medical community and third-party payors; • effectively competing with other therapies; • obtaining and maintaining third-party coverage and adequate reimbursement; • obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates; and 47 Table of Contents • maintaining a continued acceptable safety profile of any product following approval, if any.
However, we believe we have an adequate backup should any particular cell bank be lost in a catastrophic event. We currently and plan to continue to obtain bulk drug substance (BDS) for our TRACTrs and TRACIrs from a third-party contract manufacturer.
However, we believe we have an adequate backup should any particular cell bank be lost in a catastrophic event. We currently and plan to continue to obtain bulk drug substance (BDS) for our TRACTrs, TRACIrs and ARMs from a third-party contract manufacturer.
If any such actions are instituted against us those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid or comparable foreign healthcare programs, contractual damages, reputational harm, 63 Table of Contents diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations.
If any such actions are instituted against us those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid or comparable foreign healthcare programs, contractual damages, reputational harm, 65 Table of Contents diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations.
We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction or such other benefits that led us to enter into the arrangement. 62 Table of Contents We may wish to form additional collaborations in the future with respect to our product candidates, but may not be able to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction or such other benefits that led us to enter into the arrangement. 64 Table of Contents We may wish to form additional collaborations in the future with respect to our product candidates, but may not be able to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
Orphan Medicinal Product Designation In the EU, Regulation (EC) No. 141/2000, as implemented by Regulation (EC) No. 847/2000 provides that a medicinal product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish that (1) the product is 36 Table of Contents intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating conditions; (2) either (a) such conditions affect no more than five in ten thousand persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product; and (3) there exists no satisfactory authorized method of diagnosis, prevention or treatment of the condition that has been authorized in the EU or, even if such method exists, the product will be of significant benefit to those affected by that condition.
Orphan Medicinal Product Designation In the EU, Regulation (EC) No. 141/2000, as implemented by Regulation (EC) No. 847/2000 provides that a medicinal product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish that (1) the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating conditions; (2) either (a) such conditions affect no more than five in ten thousand persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify the necessary investment in developing the medicinal product; and (3) there exists no satisfactory authorized method of diagnosis, prevention or treatment of the condition that has been authorized in the EU or, even if such method exists, the product will be of significant benefit to those affected by that condition.
The market price for our common stock may be influenced by numerous factors, many of which are beyond our control, including: • adverse results or delays in preclinical studies or clinical trials; • results from our future clinical trials with our future product candidates or of our competitors; • failure to commercialize our product candidates; • unanticipated serious safety concerns related to immuno-oncology or related to the use of our product candidates; • changes in our projected operating results that we provide to the public, our failure to meet these projections or changes in recommendations by securities analysts that elect to follow our common stock; • any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information; • regulatory or legal developments in the United States and other countries; • the level of expenses related to future product candidates or clinical development programs; 85 Table of Contents • our failure to achieve product development goals in the timeframe we announce; • announcements of acquisitions, strategic alliances or significant agreements by us or by our competitors; • recruitment or departure of key personnel; • developments with respect to our intellectual property rights; • overall performance of the equity markets; • the economy as a whole and market conditions in our industry; • the published opinions and third-party valuations by banking and market analysts; • political uncertainty and/or instability in the United States; • the future impact of a health epidemic or pandemic; and • any other factors discussed in this Annual Report.
The market price for our common stock may be influenced by numerous factors, many of which are beyond our control, including: • adverse results or delays in preclinical studies or clinical trials; • results from our future clinical trials with our future product candidates or of our competitors; • failure to commercialize our product candidates; • unanticipated serious safety concerns related to immunotherapy or related to the use of our product candidates; • changes in our projected operating results that we provide to the public, our failure to meet these projections or changes in recommendations by securities analysts that elect to follow our common stock; • any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information; • regulatory or legal developments in the United States and other countries; • the level of expenses related to future product candidates or clinical development programs; 87 Table of Contents • our failure to achieve product development goals in the timeframe we announce; • announcements of acquisitions, strategic alliances or significant agreements by us or by our competitors; • recruitment or departure of key personnel; • developments with respect to our intellectual property rights; • overall performance of the equity markets; • the economy as a whole and market conditions in our industry; • the published opinions and third-party valuations by banking and market analysts; • political uncertainty and/or instability in the United States; • the future impact of a health epidemic or pandemic; and • any other factors discussed in this Annual Report.
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations. 48 Table of Contents If we experience delays in or difficulties enrolling our ongoing and planned clinical trials, our research and development efforts and business, financial condition and results of operations could be materially adversely affected.
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations. 49 Table of Contents If we experience delays in or difficulties enrolling our ongoing and planned clinical trials, our research and development efforts and business, financial condition and results of operations could be materially adversely affected.
We assessed the risk of developing CRS by dosing both agents in non-human primates (NHPs), a 13 Table of Contents species that was chosen because of the similarity in antigen binding affinities in these NHPs compared to humans, and demonstrating that an EGFR bi-specific T cell engager (EGFR-BiTE, or EGFR-TCE) triggered significant CRS and healthy tissue toxicity up to and including death.
We assessed the risk of developing CRS by dosing both agents in non-human primates (NHPs), a 14 Table of Contents species that was chosen because of the similarity in antigen binding affinities in these NHPs compared to humans, and demonstrating that an EGFR bi-specific T cell engager (EGFR-BiTE, or EGFR-TCE) triggered significant CRS and healthy tissue toxicity up to and including death.
Risks Related to Manufacturing, Commercialization and Reliance on Third Parties We rely on third parties to conduct, supervise, and/or monitor our ongoing and planned clinical trials and perform some of our research and preclinical studies.
Risks Related to Manufacturing, Commercialization and Reliance on Third Parties We rely on third parties to conduct, supervise, and monitor our ongoing and planned clinical trials and perform some of our research and preclinical studies.
A similar reduction in the other inflammatory cytokines measured was observed with our TRACTr compared to the EGFR-TCE. 14 Table of Contents Figure 7. Our EGFR-TRACTr did not lead to CRS in NHPs even at high doses. Inflammatory cytokines evaluated in this study included IL-6, tumor necrosis factor alpha (TNF a ), interferon gamma (IFN g ), and interleukin-2 (IL-2).
A similar reduction in the other inflammatory cytokines measured was observed with our TRACTr compared to the EGFR-TCE. 15 Table of Contents Figure 7. Our EGFR-TRACTr did not lead to CRS in NHPs even at high doses. Inflammatory cytokines evaluated in this study included IL-6, tumor necrosis factor alpha (TNF a ), interferon gamma (IFN g ), and interleukin-2 (IL-2).
A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business. 60 Table of Contents If any of our product candidates are approved for marketing and commercialization and we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we will be unable to successfully commercialize our product candidates if and when they are approved.
A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business. 62 Table of Contents If any of our product candidates are approved for marketing and commercialization and we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we will be unable to successfully commercialize our product candidates if and when they are approved.
Such obligations may include, without limitation, the Federal Trade Commission Act, the Telephone Consumer Protection Act of 1991, the Children’s Online Privacy Protection Act of 1998, the Controlling the Assault of Non-Solicited Pornography And Marketing Act of 2003, the 37 Table of Contents California Consumer Privacy Act of 2018 (CCPA), the Canadian Personal Information Protection and Electronic Documents Act, Canada’s Anti-Spam Legislation, the European Union’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of United Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR) (EU GDPR and UK GDPR collectively as GDPR), the ePrivacy Directive, and the Payment Card Industry Data Security Standard (PCI DSS).
Such obligations may include, without limitation, the Federal Trade Commission Act, the Telephone Consumer Protection Act of 1991, the Children’s Online Privacy Protection Act of 1998, the Controlling the Assault of Non-Solicited Pornography And Marketing Act of 2003, the California Consumer Privacy Act of 2018 (CCPA), the Canadian Personal Information Protection and Electronic Documents Act, Canada’s Anti-Spam Legislation, the European Union’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of United Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR) (EU GDPR and UK GDPR collectively as GDPR), the ePrivacy Directive, and the Payment Card Industry Data Security Standard (PCI DSS).
With the observation of reduced CRS risk for our EGFR-TRACTr relative to the EGFR-TCE (at a substantially lower dose than the TRACTr) in our NHP study, and the observation of comparable anti-tumor activity of our EGFR-TRACTr and the EGFR-TCE (at one third of the dose of the our TRACTr) in our mouse model of human CRC, we believe our EGFR-TRACTr may offer reduced CRS risk relative to the EGFR-TCE when dosed at levels expected to result in anti-tumor activity in humans. 15 Table of Contents Figure 8.
With the observation of reduced CRS risk for our EGFR-TRACTr relative to the EGFR-TCE (at a substantially lower dose than the TRACTr) in our NHP study, and the observation of comparable anti-tumor activity of our EGFR-TRACTr and the EGFR-TCE (at one third of the dose of the our TRACTr) in our mouse model of human CRC, we believe our EGFR-TRACTr may offer reduced CRS risk relative to the EGFR-TCE when dosed at levels expected to result in anti-tumor activity in humans. 16 Table of Contents Figure 8.
We believe these data suggest that our EGFR-TRACTr has the potential to reduce CRS risk relative to an unmasked EGFR-TCE. Furthermore, in a separate study of our EGFR-TRACTr dosed at 600µg/kg once-weekly for three weeks in NHPs, no dose-limiting toxicities were identified. 24 Table of Contents Figure 17.
We believe these data suggest that our EGFR-TRACTr has the potential to reduce CRS risk relative to an unmasked EGFR-TCE. Furthermore, in a separate study of our EGFR-TRACTr dosed at 600µg/kg once-weekly for three weeks in NHPs, no dose-limiting toxicities were identified. 23 Table of Contents Figure 17.
We also offer a variety of voluntary benefits that allow employees to select options that meet their needs, including a long-term care plan, an employee assistance program, and wellness programs. We benchmark our benefits program against others in our industry on an annual basis. 43 Table of Contents It em 1A. Risk Factors.
We also offer a variety of voluntary benefits that allow employees to select options that meet their needs, including a long-term care plan, an employee assistance program, and wellness programs. We benchmark our benefits program against others in our industry on an annual basis. 44 Table of Contents It em 1A. Risk Factors.
Unless our board of 86 Table of Contents directors elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution, which could cause our stock price to fall. We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
Unless our board of 88 Table of Contents directors elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution, which could cause our stock price to fall. We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. The development and commercialization of new products is highly competitive. We largely compete in the segments of the pharmaceutical, biotechnology and other related markets that develop immunotherapies for the treatment of cancer.
We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. The development and commercialization of new products is highly competitive. We largely compete in the segments of the pharmaceutical, biotechnology and other related markets that develop immunotherapies for the treatment of cancer and autoimmune disease.
In addition, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, 32 Table of Contents greater safety, or providing a major contribution to patient care, or in instances of drug supply issues.
In addition, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care, or in instances of drug supply issues.
The loss of the services of any of our executive officers, other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm our business. 64 Table of Contents We conduct substantially all of our operations remotely and at our facilities in San Diego, California.
The loss of the services of any of our executive officers, other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm our business. 66 Table of Contents We conduct substantially all of our operations remotely and at our facilities in San Diego, California.
Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. The highly competitive nature of and rapid technological changes in the 65 Table of Contents biotechnology and pharmaceutical industries could render our product candidates or our technology obsolete, less competitive or uneconomical.
Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. The highly competitive nature of and 67 Table of Contents rapid technological changes in the biotechnology and pharmaceutical industries could render our product candidates or our technology obsolete, less competitive or uneconomical.
Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; • the U.S. federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; 68 Table of Contents • analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring the registration of pharmaceutical sales representatives; and • European Union and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers.
Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; • the U.S. federal legislation commonly referred to as Physician Payments Sunshine Act, enacted as part of the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; 70 Table of Contents • analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring certain regulatory licenses to manufacture or distribute pharmaceutical products commercially and/or the registration of pharmaceutical sales representatives; and • European Union and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers.
The class of TCEs has been associated with overactivation of the immune system leading to cytokine release syndrome (CRS) and on-target healthy tissue toxicities, and while we have designed our TRACTr and TRACIr platform technologies and product candidates to mitigate these safety risks, until 49 Table of Contents such time as we complete large-scale human trials there can be no assurances that our product candidates will not experience similar effects.
The class of TCEs has been associated with overactivation of the immune system leading to cytokine release syndrome (CRS) and on-target healthy tissue toxicities, and while we have designed our TRACTr, TRACIr and ARM platform technologies and product candidates to mitigate these safety 50 Table of Contents risks, until such time as we complete large-scale human trials there can be no assurances that our product candidates will not experience similar effects.
In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third-party, which we may not be able to do on commercially reasonable terms, if at all.
In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third-party, which we may not be able 56 Table of Contents to do on commercially reasonable terms, if at all.
If we are unable to successfully advance the development of our product candidates or achieve milestones, revenue and cash resources from milestone payments under our collaboration agreement will be substantially less than expected. We are unable to predict the success of our collaborations and we may not realize the anticipated benefits of our strategic collaborations.
If we are unable to successfully advance the development of our product candidates or achieve milestones, revenue and cash resources from milestone payments under our collaboration agreements will be substantially less than expected. We are unable to predict the success of our collaborations and we may not realize the anticipated benefits of our strategic collaborations.
We depict our mask discovery process in the figure below. 11 Table of Contents Figure 3. Using directed evolution and phage display technology, we identify potential mask sequences that are designed to completely block antigen recognition by our antigen binding domains • Single versus dual masks .
We depict our mask discovery process in the figure below. 12 Table of Contents Figure 3. Using directed evolution and phage display technology, we identify potential mask sequences that are designed to completely block antigen recognition by our antigen binding domains • Single versus dual masks .
Further, because our ongoing and planned clinical trials are in patients with relapsed/refractory cancer, the patients are typically in the late stages of their disease and may experience disease progression independent from our product candidates, making them unevaluable for purposes of the clinical trial and requiring additional patient enrollment.
Further, because we have ongoing and planned clinical trials in patients with relapsed/refractory cancer, the patients are typically in the late stages of their disease and may experience disease progression independent from our product candidates, making them unevaluable for purposes of the clinical trial and requiring additional patient enrollment.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • In addition, HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), imposes certain requirements on covered entities, which include certain healthcare providers, health plans and healthcare clearinghouses, and their business associates and covered subcontractors that receive or obtain protected health information in connection with providing a service on behalf of a covered entity relating to the privacy, security and transmission of individually identifiable health information. • The federal transparency requirements under the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act (the Affordable Care Act), which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants or nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members. • Analogous state and foreign anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or that apply regardless of payor; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws that require the reporting of information related to drug pricing; state and local laws requiring the registration of pharmaceutical sales representatives.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • In addition, HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), imposes certain requirements on covered entities, which include certain healthcare providers, health plans and healthcare clearinghouses, and their business associates and covered subcontractors that receive or obtain protected health information in connection with providing a service on behalf of a covered entity relating to the privacy, security and transmission of individually identifiable health information. 40 Table of Contents • The federal transparency requirements under the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act (the Affordable Care Act), which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants or nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members. • Analogous state and foreign anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or that apply regardless of payor; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws that require the reporting of information related to drug pricing; and state and local laws requiring certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives.
For example, we constructed two PSMA TCEs with similar binding domains but of different geometry, where their potency in T cell-directed, PSMA-specific tumor cell killing differed by over 900-fold, as shown in the figure below. 10 Table of Contents Figure 2.
For 11 Table of Contents example, we constructed two PSMA TCEs with similar binding domains but of different geometry, where their potency in T cell-directed, PSMA-specific tumor cell killing differed by over 900-fold, as shown in the figure below. Figure 2.
At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. • Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an • adequate basis for product labeling.
At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. • Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an 32 Table of Contents • adequate basis for product labeling.
If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the 39 Table of Contents violation, including, among others, significant administrative, civil and criminal penalties, damages, fines, disgorgement, reputational harm, imprisonment, integrity oversight and reporting obligations, and exclusion from participation in federal healthcare programs such as Medicare and Medicaid or comparable foreign programs.
If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the violation, including, among others, significant administrative, civil and criminal penalties, damages, fines, disgorgement, reputational harm, imprisonment, integrity oversight and reporting obligations, and exclusion from participation in federal healthcare programs such as Medicare and Medicaid or comparable foreign programs.
U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations (collectively, Trade Laws) prohibit, among other things, companies and their employees, agents, CROs, 93 Table of Contents legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector.
U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations (collectively, Trade Laws) prohibit, among other things, companies and their employees, agents, CROs, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector.
Our commercial success will 28 Table of Contents depend in part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions, and improvements; to preserve the confidentiality of our trade secrets and know-how; to obtain and maintain licenses to use intellectual property owned by third parties; to defend and enforce our proprietary rights, including any patents that we may own in the future; and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties.
Our commercial success will depend in part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions, and improvements; to preserve the confidentiality of our trade secrets and know-how; to obtain and maintain licenses to use intellectual property owned by third parties; to defend and enforce our proprietary rights, including any patents that we may own in the future; and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties.
Interchangeability requires that a biological product be biosimilar to the reference product and that the product can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times to an individual, that the product and the reference product may be alternated or switched after one has been previously administered 34 Table of Contents without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch.
Interchangeability requires that a biological product be biosimilar to the reference product and that the product can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times to an individual, that the product and the reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch.
Other potential consequences include, among other things: • restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls; • fines, warning or other enforcement-related letters or holds on post-approval clinical studies; • refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product approvals; • product seizure or detention, or refusal to permit the import or export of products; or • injunctions or the imposition of civil or criminal penalties.
Other potential consequences include, among other things: 35 Table of Contents • restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls; • fines, warning or other enforcement-related letters or holds on post-approval clinical studies; • refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product approvals; • product seizure or detention, or refusal to permit the import or export of products; or • injunctions or the imposition of civil or criminal penalties.
Moreover, with the proliferation of new drugs and therapies into oncology, we expect to face increasingly intense competition as new technologies become available. If we fail to stay at the forefront of technological change, we may be unable to compete effectively.
Moreover, with the proliferation of new drugs and therapies into oncology and autoimmune disease, we expect to face increasingly intense competition as new technologies become available. If we fail to stay at the forefront of technological change, we may be unable to compete effectively.
The overall 59 Table of Contents ten year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The overall ten year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
Our observation is consistent with published studies demonstrating EGFR-TCE activity in cell lines resistant to EGFR mAbs and harbored KRAS mutations. The results of our study are depicted in the figure below. 23 Table of Contents Figure 15.
Our observation is consistent with published studies demonstrating EGFR-TCE activity in cell lines resistant to EGFR mAbs and harbored KRAS mutations. The results of our study are depicted in the figure below. 22 Table of Contents Figure 15.
Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product 29 Table of Contents candidate can be commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.
Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.
Other companies using PSMA-targeting therapeutics for the treatment of cancer include AbbVie, Amgen, Bayer, Crescendo Biologics, Eli Lilly, Johnson and Johnson, Lava Therapeutics, Novartis, Regeneron and Vir Biotechnology. We also face competition from biologic prodrug developers such as Adagene, Chugai Pharmaceutical Co./Roche Holding AG, CytomX Therapeutics, Merck & Co., Takeda and Vir Biotechnology.
Other companies using PSMA-targeting therapeutics for the treatment of cancer include AbbVie, Amgen, AstraZeneca, Bayer, Crescendo Biologics, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Lantheus, Lava Therapeutics, Novartis, Regeneron and Vir Biotechnology. We also face competition from biologic prodrug developers such as Adagene, Chugai Pharmaceutical Co./Roche Holding AG, CytomX Therapeutics, Merck & Co., Takeda and Vir Biotechnology.
Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use and sell our product candidates.
Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing 81 Table of Contents technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use and sell our product candidates.
We do not have a disaster recovery or business continuity plan in place and may incur substantial expenses as a result of the absence or limited nature of our internal or third-party service provider disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.
We do not have a disaster recovery or business continuity plan in place and may incur substantial expenses as a result of the absence or limited nature of our internal or third-party service provider 94 Table of Contents disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.
First, our TRACTr and TRACIr molecules are readily expressed at high levels recombinantly in common Chinese hamster ovary cells. Second, our TRACTr and TRACIr molecules bind protein A via the anti-albumin-binding domain. Protein A affinity chromatography is the standard technique for capturing recombinant monoclonal antibodies and is a very robust purification procedure due to its specificity.
First, our platform molecules are readily expressed at high levels recombinantly in common Chinese hamster ovary cells. Second, our platform molecules bind protein A via the anti-albumin-binding domain. Protein A affinity chromatography is the standard technique for capturing recombinant monoclonal antibodies and is a very robust purification procedure due to its specificity.
Any product candidates that we successfully develop and commercialize will compete with new immunotherapies that may become available in the future. We compete in the segments of the pharmaceutical, biotechnology, and other related markets that develop immuno-oncology treatments.
Any product candidates that we successfully develop and commercialize will compete with new immunotherapies that may become available in the future. We compete in the segments of pharmaceutical, biotechnology, and other related markets that develop immuno-oncology and autoimmune disease treatments.
If we or any of our CROs or clinical trial sites fail to comply with applicable GLP or GCP requirements, the data generated in our preclinical studies and clinical trials may be deemed unreliable, and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional preclinical or clinical trials before approving our marketing authorization applications.
If we or any of our CROs or clinical trial sites fail to comply with applicable GLP or GCP requirements, the data 55 Table of Contents generated in our preclinical studies and clinical trials may be deemed unreliable, and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional preclinical or clinical trials before approving our marketing authorization applications.
However, an unwanted consequence of CytomX’s approach is that the relatively long half-lives of its drugs in active form led to their accumulation in healthy tissue throughout treatment. We are developing our TRACTr and TRACIr platforms to address the limitations of previous generations of immuno-oncology drugs and to restrict activity to tumors.
However, an unwanted consequence of CytomX’s 9 Table of Contents approach is that the relatively long half-lives of its drugs in active form led to their accumulation in healthy tissue throughout treatment. We are developing our TRACTr and TRACIr platforms to address the limitations of previous generations of immuno-oncology drugs and to restrict activity to tumors.
We have identified several 12 Table of Contents proprietary cleavable linkers that we utilize to optimize efficacy and stability in our TRACTrs and TRACIrs, as shown in the schematic below. • Albumin-binding domain .
We have identified several 13 Table of Contents proprietary cleavable linkers that we utilize to optimize efficacy and stability in our TRACTrs and TRACIrs, as shown in the schematic below. • Albumin-binding domain .
Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private 57 Table of Contents payors, by any future laws limiting drug prices and by any future relaxation of laws that presently restrict imports of product from countries where they may be sold at lower prices than in the United States.
Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors, by any future laws limiting drug prices and by any future relaxation of laws that presently restrict imports of product from countries where they may be sold at lower prices than in the United States.
Accordingly, the reimbursement for any products in the European Union may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits. Furthermore, the containment of healthcare costs has become a priority of foreign and domestic governments as well as private third-party payors.
Accordingly, the reimbursement for any products in the European Union may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits. 43 Table of Contents Furthermore, the containment of healthcare costs has become a priority of foreign and domestic governments as well as private third-party payors.
If our defenses to these claims fail, in addition to 81 Table of Contents requiring us to pay monetary damages, a court could prohibit us from using technologies or features that are essential to our product candidates, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.
If our defenses to these claims fail, in addition to requiring us to pay monetary damages, a court could prohibit us from using technologies or features that are essential to our product candidates, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. 83 Table of Contents Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
Future guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation. In addition, it is uncertain if and to what extent various states will conform to federal tax laws.
Future guidance from the Internal Revenue Service and other tax authorities with respect to any legislation may affect us, and certain aspects of such legislation could be repealed or modified or sunset in future years. In addition, it is uncertain if and to what extent various states will conform to federal tax laws.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications 95 Table of Contents at risk of not issuing and could provoke third parties to assert claims against us.
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen or PSMA-TRACTr and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen (PSMA) TRACTr being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
Through developability and manufacturability assessments, we continue to verify that our TRACTr and TRACIr constructs have advantageous properties that include high solubility, minimal aggregation, and good stability. We believe all these attributes allow our products to be manufactured at a substantially lower cost-per-dose than monoclonal antibodies.
Through developability and manufacturability assessments, we continue to verify that our platform constructs have advantageous properties that include high solubility, minimal aggregation, and good stability. We believe all these attributes allow our products to be manufactured at a substantially lower cost-per-dose than monoclonal antibodies.
We are currently developing a pipeline of TRACTr and other protease-activated therapeutics that face increasing competition from other biologic prodrug developers, which include, but are not limited to, Adagene, BioAtla, Chugai Pharmaceutical Co./Roche Holding AG, CytomX Therapeutics, Merck & Co., Takeda, Vir Biotechnology, and Xilio Therapeutics.
We are currently developing a pipeline of TRACTr and other protease-activated therapeutics that face increasing competition from other biologic prodrug developers, which include, but are not limited to, Adagene, Astellas, BioAtla, Chugai Pharmaceutical Co./Roche Holding AG, CytomX Therapeutics, Merck & Co., Regeneron, Vir Biotechnology and Xilio Therapeutics.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process, with uncertain results, that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our products to the payor.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process, with uncertain results, that could require us to provide supporting scientific, 58 Table of Contents clinical and cost effectiveness data for the use of our products to the payor.
We take steps designed to detect, mitigate and remediate vulnerabilities in our information security systems (such as our hardware and/or software, including that of third parties with whom we work), but we have not been and may not be able to detect, mitigate, and remediate all such vulnerabilities including on a timely basis.
We take steps designed to detect, mitigate and remediate vulnerabilities in our information security systems (such as our hardware and/or software, including that of third 93 Table of Contents parties with whom we work), but we have not been and may not be able to detect, mitigate, and remediate all such vulnerabilities including on a timely basis.
Structure of JANX008 We found that our EGFR-TRACTr product candidate exhibited an 8,500-fold shift in activating T cell killing of EGFR expressing HCT116 tumor cells in an in vitro assay when it was masked than when the mask was removed, as shown below.
We illustrate the JANX008 structure below. Figure 14. Structure of JANX008 We found that our EGFR-TRACTr product candidate exhibited an 8,500-fold shift in activating T cell killing of EGFR expressing HCT116 tumor cells in an in vitro assay when it was masked than when the mask was removed, as shown below.
If our license agreements are terminated, we may experience significant delays, difficulties, and costs in developing new cell lines and identifying an alternative source to manufacture components of our candidate products covered by our agreements and those being tested or approved in combination with such products.
If our license agreements are terminated, we may experience significant delays, difficulties, and costs in developing new cell lines and identifying an alternative source to manufacture components of our candidate products covered by our 79 Table of Contents agreements and those being tested or approved in combination with such products.
We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the 91 Table of Contents Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
The development, manufacturing and control processes of our TRACTr and TRACIr molecules closely resemble those used for monoclonal antibodies (mAbs) with the expectation for a relatively lower cost of goods. A schematic of our proprietary TRACTrs and TRACIrs in development and their modular components is depicted below.
The development, manufacturing and control processes of our TRACTr and TRACIr molecules closely resemble those used for monoclonal antibodies (mAbs) with the expectation for a relatively lower cost of goods. 5 Table of Contents A schematic of our proprietary TRACTrs and TRACIrs in development and their modular components is depicted below.
An ETASU can include, but is not limited to, special training or certification for prescribing or dispensing the product, dispensing the product only under certain circumstances, special monitoring and the use of patient-specific registries. The requirement for a REMS can materially affect the potential market and profitability of the product.
An ETASU can include, but is not limited to, special 33 Table of Contents training or certification for prescribing or dispensing the product, dispensing the product only under certain circumstances, special monitoring and the use of patient-specific registries. The requirement for a REMS can materially affect the potential market and profitability of the product.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThis group identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment and our risk profile using various methods including, for example manual and automated tools, subscribing to reports and services that identify cybersecurity threats, evaluating our and our industry’s risk profile, evaluating threats reported to us and coordinating with law enforcement about such threats as may be appropriate, conducting internal and external audits, conducting internal threat assessments to evaluate for both internal and external threats, having third parties conduct threat assessments, and conducting vulnerability assessments designed to identify vulnerabilities. 95 Table of Contents Depending on the environment, systems and data, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example, an incident response policy; incident detection and response processes; a vulnerability management policy; a disaster recovery plan; risk assessments; encrypting certain data; network security controls; data segregation; maintaining access and physical controls; asset management, tracking and disposal; systems monitoring; employee training; penetration testing conducted by third parties; maintaining cybersecurity insurance; and having dedicated cybersecurity staff.
Biggest changeDepending on the environment, systems and data, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example, an incident response policy; incident detection and response processes; a vulnerability management policy; a disaster recovery plan; risk assessments; encrypting certain data; network security controls; data segregation; maintaining access and physical controls; asset management, tracking and disposal; systems monitoring; employee training; penetration testing conducted by third parties; maintaining cybersecurity insurance; and having dedicated cybersecurity staff.
Investing Activities Net cash used in investing activities of $258.0 million for the year ended December 31, 2024 was primarily due to $257.7 million of net purchases of short-term investments and by our purchase of property and equipment, primarily consisting of laboratory equipment of $0.3 million.
Net cash used in investing activities of $258.0 million for the year ended December 31, 2024 was primarily due to $257.7 million of net purchases of short-term investments and our purchase of property and equipment, primarily consisting of laboratory equipment of $0.3 million.
Research and Development To date, our research and development expenses have related primarily to direct and indirect expenses in connection with the development of our TRACTr and TRACIr platforms, discovery efforts and preclinical and clinical development of our product candidates.
Research and Development To date, our research and development expenses have related primarily to direct and indirect expenses in connection with the development of our TRACTr, TRACIr and ARM platforms, discovery efforts and preclinical and clinical development of our product candidates.
Merck received an exclusive worldwide license for each selected target and intellectual property from the collaboration. In return, we are eligible to receive up to $500.5 million per target in upfront and milestone payments, plus royalties on sales 100 Table of Contents of the products derived from the collaboration.
Merck received an exclusive worldwide license for each selected target and intellectual property from the collaboration. In return, we are eligible to receive up to $500.5 million per target in upfront and milestone payments, plus royalties on sales 101 Table of Contents of the products derived from the collaboration.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see the section of this Annual Report on Form 10-K titled “Risk Factors”, including, but not limited to, the risk factor titled “If our internal information technology systems or sensitive information, or those of our third-party CROs or other contractors or consultants, are or were compromised, we could experience adverse consequences from such compromise, including but not limited to, a material disruption of our product candidates’ development programs, regulatory investigations or actions, litigation, fines and penalties, reputational harm, loss of revenue or profits, and other adverse consequences.” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see the section of this Annual Report on Form 10-K titled “Risk Factors”, including, but not limited to, the risk factor titled “If our internal information technology systems or sensitive information, or those of third parties with whom we work (such as CROs or other contractors or consultants), are or were compromised, we could experience adverse consequences from such compromise, including but not limited to, a material disruption of our product candidates’ development programs, regulatory investigations or actions, litigation, fines and penalties, reputational harm, loss of revenue or profits, and other adverse consequences.” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.
While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors has faced challenges due to the limitations of prior TCE technologies, namely (i) on-target healthy tissue immune activation that contributes to cytokine release syndrome (CRS) and healthy tissue toxicity and (ii) poor pharmacokinetics (PK) leading to short half-life.
While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors has faced challenges due to the limitations of prior TCE technologies, namely (i) on-target healthy tissue immune activation that contributes to cytokine release syndrome (CRS) and healthy tissue toxicity and (ii) poor 100 Table of Contents pharmacokinetics (PK) leading to short half-life.
Stock Performance Graph The following stock performance graph illustrates a comparison from June 11, 2021 (the date our common stock commenced trading on the Nasdaq Global Market) through December 31, 2024, of the total cumulative stockholder return on our common stock, the Nasdaq Composite Index and the Nasdaq Biotechnology Index.
Stock Performance Graph The following stock performance graph illustrates a comparison from June 11, 2021 (the date our common stock commenced trading on the Nasdaq Global Market) through December 31, 2025, of the total cumulative stockholder return on our common stock, the Nasdaq Composite Index and the Nasdaq Biotechnology Index.
Risk Factors.” Additionally, our discussion and analysis below are focused on our financial results and liquidity and capital resources for the years ended December 31, 2024 and 2023, including year-over-year comparisons of our financial performance and condition for these years.
Risk Factors.” Additionally, our discussion and analysis below are focused on our financial results and liquidity and capital resources for the years ended December 31, 2025 and 2024, including year-over-year comparisons of our financial performance and condition for these years.
The comparisons in the graph are required by the SEC and are not intended to forecast or be indicative of possible future performance of our common stock. 98 Table of Contents Recent Sales of Unregistered Securities None.
The comparisons in the graph are required by the SEC and are not intended to forecast or be indicative of possible future performance of our common stock. 99 Table of Contents Recent Sales of Unregistered Securities None.
Financing Activities Net cash provided by financing activities of $713.2 million for the year ended December 31, 2024 was primarily due to proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs, of $698.3 million, and exercises of common stock options and from shares issued under our 2021 Employee Stock Purchase Plan (ESPP) of $14.9 million.
Net cash provided by financing activities of $713.2 million for the year ended December 31, 2024 was primarily due to proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs, of $698.3 million, and exercises of common stock options and from shares issued under our 2021 ESPP of $14.9 million.
We have the right (but not the obligation) to buy out our remaining 105 Table of Contents royalty obligations with respect to each WuXi Biologics Licensed Product by paying WuXi Biologics a one-time payment in an amount ranging from low single digit million dollars to a maximum of $15.0 million (Buyout Option).
We have the right (but not the obligation) to buy out our remaining royalty obligations with respect to each WuXi Biologics Licensed Product by paying WuXi Biologics a one-time payment in an amount ranging from low single digit million dollars to a maximum of $15.0 million (Buyout Option).
Risk management and strategy We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to our development programs and clinical trials (Information Systems and Data).
Risk management and strategy We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential 96 Table of Contents information that is proprietary, strategic or competitive in nature, and data related to our development programs and clinical trials (Information Systems and Data).
We have funded our operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the exercise of common stock options, proceeds from our initial public offering (IPO), the issuance of common stock and pre-funded common stock warrants in public and/or underwritten offerings and amounts received under a collaboration agreement with Merck Sharp & Dohme Corp.
We have funded our operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the exercise of common stock options, proceeds from our initial public offering (IPO), the issuance of common stock and pre-funded common stock warrants in public and/or underwritten offerings and amounts received under a collaboration agreement with Merck.
For development and regulatory milestones that are uncertain in nature and highly dependent on factors outside of our control, the aggregate consideration is determined to be fully constrained and is not included in the transaction price until the underlying events occur or the associated approvals are received.
For development and regulatory milestones that are uncertain in nature and highly dependent on factors outside of our control, the aggregate consideration is determined to be fully constrained and is not included 107 Table of Contents in the transaction price until the underlying events occur or the associated approvals are received.
The audit committee also has access to various reports, summaries and presentations related to cybersecurity threats, risks and mitigation. 96 Table of Contents It em 2. Properties. Our corporate headquarters is located in San Diego, California, where we lease office and laboratory space pursuant to a lease agreement which commenced in July, 2022 and expires in January, 2033.
The audit committee also has access to various reports, summaries and presentations related to cybersecurity threats, risks and mitigation. It em 2. Properties. Our corporate headquarters is located in San Diego, California, where we lease office and laboratory space pursuant to a lease agreement which commenced in July 2022 and expires in January 2033.
We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including for example, professional services firms (including legal counsel), cybersecurity consultants, cybersecurity software providers, and penetration testing firms.
We use third-party service providers to assist us from time to time in our efforts to identify, assess, and manage material risks from cybersecurity threats, including for example, professional services firms (including legal counsel), cybersecurity consultants, cybersecurity software providers, and penetration testing firms.
The shares of 103 Table of Contents common stock were sold at a price of $46.50 per share and the pre-funded common stock warrants were sold at a price of $46.499 per pre-funded common stock warrant, resulting in gross proceeds of $341.0 million.
The shares of common stock were sold at a price of $46.50 per share and the pre-funded common stock warrants were sold at a price of $46.499 per pre-funded common stock warrant, resulting in gross proceeds of $341.0 million.
You should read the following discussion and analysis together with our financial statements and related notes included in “Item 8. Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that involve risks and uncertainties.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes included in “Item 8. Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that involve risks and uncertainties.
Our General Counsel is responsible for approving budgets and, along with our Senior Director of IT, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our General Counsel is responsible for approving budgets and, along with our Senior Director of IT, helping prepare 97 Table of Contents for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our financial statements.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities 106 Table of Contents in our financial statements.
When an entity grants a customer the option to acquire additional goods or services, that 106 Table of Contents option is a separate performance obligation only if it provides a material right to the customer that the customer would not receive without entering into the contract.
When an entity grants a customer the option to acquire additional goods or services, that option is a separate performance obligation only if it provides a material right to the customer that the customer would not receive without entering into the contract.
The significant estimates in our accrued clinical trial and research and 107 Table of Contents development expenses include the costs incurred for services performed by our vendors in connection with clinical trial and research and development activities for which we have not yet been invoiced.
The significant estimates in our accrued clinical trial and research and development expenses include the costs incurred for services performed by our vendors in connection with clinical trial and research and development activities for which we have not yet been invoiced.
Our future capital requirements will depend on many factors, including: • the initiation, trial design, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of our product candidates, and in particular the clinical trials for JANX007 and JANX008; • the number and characteristics of clinical programs that we pursue; • the outcome, timing and costs of seeking FDA, European Commission and any other comparable regulatory approvals for any future drug candidates; • the costs of manufacturing our product candidates; • the costs associated with hiring additional personnel and consultants as our preclinical, manufacturing and clinical activities increase; • the receipt of marketing approval and revenue received from any commercial sales of any of our product candidates, if approved; • the cost of commercialization activities for any of our product candidates, if approved, including marketing, sales and distribution costs; • the ability to establish and maintain strategic collaboration, licensing or other arrangements and the financial terms of such agreements; • the extent to which we in-license or acquire other products and technologies; • the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; • our implementation of additional internal systems and infrastructure, including operational, financial and management information systems; • our costs associated with expanding our facilities or building out our laboratory space; • the effects of the disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions, including the military conflict in Ukraine and Russia, the war in the Middle East, epidemics and bank failures; and • the costs of operating as a public company.
Our future capital requirements will depend on many factors, including: • the initiation, trial design, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of our product candidates, and in particular the clinical trials for JANX007 and JANX008; • the number and characteristics of clinical programs that we pursue; • the outcome, timing and costs of seeking FDA, European Commission and any other comparable regulatory approvals for any future drug candidates; • the costs of manufacturing our product candidates; • the costs associated with hiring additional personnel and consultants as our preclinical, manufacturing and clinical activities increase; • the receipt of marketing approval and revenue received from any commercial sales of any of our product candidates, if approved; • the cost of commercialization activities for any of our product candidates, if approved, including marketing, sales and distribution costs; • the ability to establish and maintain strategic collaboration, licensing or other arrangements and the financial terms of such agreements; • the extent to which we in-license or acquire other products and technologies; 105 Table of Contents • the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; • our implementation of additional internal systems and infrastructure, including operational, financial and management information systems; • our costs associated with expanding our facilities or building out our laboratory space; • the effects of the disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions, including recent and changing tariff policy announcements, tariffs, trade tensions and retaliatory measures by other countries, supply chain disruptions, recession risks, the military conflict in Ukraine and Russia, the war in the Middle East, epidemics and bank failures; and • the costs of operating as a public company.
Discussion and analysis of the year ended December 31, 2022 specifically, as well as the year-over-year comparison of our financial performance and condition for the years ended December 31, 2023 and 2022, are located in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 8, 2024.
Discussion and analysis of the year ended December 31, 2023 specifically, as well as the year-over-year comparison of our financial performance and condition for the years ended December 31, 2024 and 2023, are located in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 27, 2025.
As of December 31, 2024, we have used $18.5 million of the proceeds from our IPO and there has been no material change in the planned use of such proceeds from that described in the final prospectus filed by us with the SEC on June 11, 2021.
As of December 31, 2025, we have used $121.8 million of the proceeds from our IPO and there has been no material change in the planned use of such proceeds from that described in the final prospectus filed by us with the SEC on June 11, 2021.
Inflation generally affects us by increasing our salaries and fees paid to third-party contract service providers. We have considered potential impacts arising from the risks and uncertainties as described above and have not experienced any material disruption to our operations to date. Support Services Agreement with Avalon BioVentures, Inc.
Inflation generally affects us by increasing our salaries and fees paid to third-party contract service providers. We have considered potential impacts arising from the risks and uncertainties as described above and have not experienced any material disruption to our operations to date.
These contracts provide for termination upon notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
We recognized $10.6 million and $8.1 million of revenue under the Merck Agreement for the years ended December 31, 2024 and 2023, respectively.
We recognized $10.0 million and $10.6 million of revenue under the Merck Agreement for the years ended December 31, 2025 and 2024, respectively.
(Merck). We have incurred operating losses since our inception and have not yet generated any product revenue. Our net losses were $69.0 million and $58.3 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $237.8 million.
We have incurred operating losses since our inception and have not yet generated any product revenue. Our net losses were $113.6 million and $69.0 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $351.4 million.
As of December 31, 2024, $150.0 million of common stock remained available for sale under the Sale Agreement. In July 2023, we closed an underwritten offering of 4,153,717 shares of our common stock and pre-funded warrants to purchase 583,483 shares of common stock at an exercise price of $0.001 per share.
As of December 31, 2025, $150.0 million of common stock remained available for sale under the Sale Agreement. In March 2024, we closed an underwritten offering of 5,397,301 shares of our common stock and pre-funded warrants to purchase 1,935,483 shares of common stock at an exercise price of $0.001 per share.
The 2021 Support Services Agreement terminated on December 31, 2024. Financial Operations Overview Revenues To date, we have not generated any revenues from the commercial sale of any products, and we do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever.
Financial Operations Overview Revenues To date, we have not generated any revenues from the commercial sale of any products, and we do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever.
Inclusive in this amount is $0.8 million of restricted cash that is not available for current use. In May 2023, we entered into an ATM Equity Offering SM Sales Agreement (Sale Agreement) with BofA Securities, Inc.
As of December 31, 2025, we had cash, cash equivalents, restricted cash and short-term investments of $967.4 million. Inclusive in this amount is $0.8 million of restricted cash that is not available for current use. In May 2023, we entered into an ATM Equity Offering SM Sales Agreement (Sale Agreement) with BofA Securities, Inc.
Net cash used in investing activities of $41.2 million for the year ended December 31, 2023 was primarily due to $39.3 million of net purchases of short-term investments and by our purchase of property and equipment, primarily consisting of laboratory equipment of $1.9 million.
Investing Activities Net cash used in investing activities of $301.0 million for the year ended December 31, 2025 was primarily due to $300.0 million of net purchases of short-term investments and our purchase of property and equipment, primarily consisting of laboratory equipment of $1.0 million.
Risks and Uncertainties Global economic and business activities continue to face widespread macroeconomic uncertainties, including those associated with public health crises, bank failures, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict, the war in the Middle East and related sanctions.
Risks and Uncertainties Global economic and business activities continue to face widespread geopolitical and macroeconomic uncertainties, including those associated with public health crises, bank failures, inflation and monetary supply shifts, recent and changing tariff policy announcements, tariffs, trade tensions and retaliatory measures by other countries, supply chain disruptions, recession risks and potential disruptions from the Russia-Ukraine conflict, the war in the Middle East and related sanctions.
Regardless of outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. It em 4. Mine Safety Disclosures. Not applicable. 97 Table of Contents PART II It em 5.
We are not currently a party to any material legal proceedings. Regardless of outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. It em 4. Mine Safety Disclosures.
However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.
However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect.
Net cash used in operating activities of $50.6 million for the year ended December 31, 2023 was primarily due to our net loss of $58.3 million and a change in operating assets and liabilities and other non-cash charges of $12.3 million, adjusted for $20.0 million of stock-based compensation expense.
Net cash used in operating activities of $43.8 million for the year ended December 31, 2024 was primarily due to our net loss of $69.0 million and a change in operating assets and liabilities and other non-cash charges of $7.8 million, offset by $33.0 million of stock-based compensation expense.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “JANX” since our initial public offering on June 11, 2021. Prior to that date, there was no public market for our common stock.
Not applicable. 98 Table of Contents PART II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “JANX” since our initial public offering on June 11, 2021.
Holders of Common Stock As of February 25, 2025, there were 59,105,147 shares of common stock issued and held by approximately 16 stockholders of record. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Stock-Based Compensation Expense Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options, restricted stock units and employee stock purchase plan rights, recognized on a straight-line basis over the requisite service period for stock options and restricted stock units and over the respective offering period for employee stock purchase plan rights.
To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred. 108 Table of Contents Stock-Based Compensation Expense Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options, restricted stock units and employee stock purchase plan rights, recognized on a straight-line basis over the requisite service period for stock options and restricted stock units and over the respective offering period for employee stock purchase plan rights.
The following summarizes our cash flows for the periods indicated (in thousands): Year Ended December 31, 2024 2023 Net cash provided by (used in): Operating activities $ (43,814 ) $ (50,575 ) Investing activities (258,021 ) (41,194 ) Financing activities 713,235 59,548 Net increase (decrease) in cash, cash equivalents and restricted cash $ 411,400 $ (32,221 ) Operating Activities Net cash used in operating activities of $43.8 million for the year ended December 31, 2024 was primarily due to our net loss of $69.0 million and a change in operating assets and liabilities and other non-cash charges of $7.8 million, adjusted for $33.0 million of stock-based compensation expense.
The following summarizes our cash flows for the periods indicated (in thousands): Year Ended December 31, 2025 2024 Net cash provided by (used in): Operating activities $ (82,235 ) $ (43,814 ) Investing activities (300,981 ) (258,021 ) Financing activities 4,945 713,235 Net increase (decrease) in cash, cash equivalents and restricted cash $ (378,271 ) $ 411,400 104 Table of Contents Operating Activities Net cash used in operating activities of $82.2 million for the year ended December 31, 2025 was primarily due to our net loss of $113.6 million and a change in operating assets and liabilities and other non-cash charges of $8.8 million, offset by $40.2 million of stock-based compensation expense.
Our indirect research and development expenses include: • salaries and employee-related costs, including recruiting fees and stock-based compensation for those individuals involved in research and development efforts; • maintenance of facilities and equipment, software license fees, depreciation; and • allocated facilities and equipment-related expenses, which include rent, utilities, insurance, and office supplies. 101 Table of Contents We anticipate that our research and development expenses will substantially increase for the foreseeable future as we continue the development of our TRACTr and TRACIr platforms and the discovery and development of product candidates under our TRACTr and TRACIr platforms.
Our indirect research and development expenses include: • salaries and employee-related costs, including recruiting fees and stock-based compensation for those individuals involved in research and development efforts; • maintenance of facilities and equipment, software license fees, depreciation; and • allocated facilities and equipment-related expenses, which include rent, utilities, insurance, and office supplies.
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen or PSMA-TRACTr and is being investigated 99 Table of Contents in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).
Our first clinical candidate, JANX007, is a prostate-specific membrane antigen (PSMA) TRACTr being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Our second clinical candidate, JANX008, is an epidermal growth factor receptor (EGFR) TRACTr being investigated in a Phase 1 clinical trial for the treatment of multiple solid tumors.
Net cash provided by financing activities of $59.5 million for the year ended December 31, 2023 was primarily due to proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs, of $56.5 million, and exercises of common stock options and from shares issued under our ESPP of $3.0 million.
Financing Activities Net cash provided by financing activities of $4.9 million for the year ended December 31, 2025 was primarily due to exercises of common stock options and from shares issued under our 2021 Employee Stock Purchase Plan (ESPP) of $5.2 million, offset by issuance costs paid in connection with an underwritten offering in December 2024 of $0.3 million.
We believe that our existing facilities are adequate for the foreseeable future. As we expand, we believe that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required. Ite m 3. Legal Proceedings.
As we expand, we believe that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required. Ite m 3. Legal Proceedings. From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business.
Liquidity and Capital Resources We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses and negative cash flows for the foreseeable future. As of December 31, 2024, we had cash, cash equivalents, restricted cash and short-term investments of $1.0 billion.
The increase of $14.1 million was due to an increased cash and cash equivalents balance resulting in increased interest income. Liquidity and Capital Resources We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses and negative cash flows for the foreseeable future.
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. Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets, but overcome liabilities associated with prior generations of TCEs.
The goal of our TRACTr and TRACIr 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.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 (in thousands) Year Ended December 31, 2024 2023 Change Collaboration revenue $ 10,588 $ 8,083 $ 2,505 Operating expenses: Research and development 68,388 54,922 13,466 General and administrative 41,047 26,140 14,907 Total operating expenses 109,435 81,062 28,373 Loss from operations (98,847 ) (72,979 ) (25,868 ) Other income 29,853 14,686 15,167 Net loss $ (68,994 ) $ (58,293 ) $ (10,701 ) Collaboration Revenue Collaboration revenues were $10.6 million and $8.1 million for the years ended December 31, 2024 and 2023, respectively.
Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 (in thousands) Year Ended December 31, 2025 2024 Change Collaboration revenue $ 10,000 $ 10,588 $ (588 ) Operating expenses: Research and development 125,896 68,388 57,508 General and administrative 41,771 41,047 724 Total operating expenses 167,667 109,435 58,232 Loss from operations (157,667 ) (98,847 ) (58,820 ) Other income 44,042 29,853 14,189 Net loss $ (113,625 ) $ (68,994 ) $ (44,631 ) Collaboration Revenue Collaboration revenues were $10.0 million and $10.6 million for the years ended December 31, 2025 and 2024, respectively.
We will need to raise substantial additional capital in the future. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. 102 Table of Contents General and Administrative General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, finance and other administrative functions.
General and Administrative Expense General and administrative expenses were $41.0 million and $26.1 million for the years ended December 31, 2024 and 2023, respectively. The increase of $14.9 million was primarily due to increases in stock-based compensation of $11.2 million, consulting and professional fees of $2.2 million and other general and administrative expenses of $1.5 million.
The increase of $57.5 million was primarily due to increases in preclinical stage programs and other direct unallocated costs of $31.0 million, indirect costs as a result of increased compensation costs of $16.2 million, direct costs related to the development of JANX007 of $9.2 million and direct costs related to the development of JANX008 of $1.1 million. 103 Table of Contents General and Administrative Expense General and administrative expenses were $41.8 million and $41.0 million for the years ended December 31, 2025 and 2024, respectively.
See Note 3 to our audited financial statements appearing in Part II, Item 8 of this Annual Report on Form 10-K for additional information. We enter into contracts in the normal course of business with various third parties for preclinical and clinical research studies and testing, manufacturing and other services and products for operating purposes.
We enter into contracts in the normal course of business with various third parties for preclinical and clinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts provide for termination upon notice.
Research and Development Expense The following table summarizes our direct and indirect research and development expenses for the years ended December 31, 2024 and 2023 (in thousands): 102 Table of Contents Year Ended December 31, 2024 2023 Change Direct costs: JANX007 $ 15,655 $ 7,895 $ 7,760 JANX008 6,541 5,401 1,140 Preclinical stage programs and other direct unallocated costs 13,223 13,950 (727 ) Total direct costs 35,419 27,246 8,173 Indirect costs 32,969 27,676 5,293 Total research and development expenses $ 68,388 $ 54,922 $ 13,466 IND applications for JANX007 and JANX008 were cleared by the U.S.
Research and Development Expense The following table summarizes our direct and indirect research and development expenses for the years ended December 31, 2025 and 2024 (in thousands): Year Ended December 31, 2025 2024 Change Direct costs: JANX007 $ 24,834 $ 15,655 $ 9,179 JANX008 7,631 6,541 1,090 Preclinical stage programs and other direct unallocated costs 44,263 13,223 31,040 Total direct costs 76,728 35,419 41,309 Indirect costs 49,168 32,969 16,199 Total research and development expenses $ 125,896 $ 68,388 $ 57,508 Research and development expenses were $125.9 million and $68.4 million for the years ended December 31, 2025 and 2024, respectively.
The increase of $13.5 million was primarily due to increases in direct costs related to the development of JANX007 of $7.8 million, direct costs related to the development of JANX008 of $1.1 million and indirect costs of $5.3 million, offset by decreases in preclinical stage programs and other direct unallocated costs of $0.7 million.
The increase of $0.8 million was primarily due to increases in compensation costs of $1.6 million and other general and administrative costs of $1.7 million.
Overview We are an innovative clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Our proprietary technology has enabled the development of two distinct bispecific platforms: Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr).
Overview We are an innovative clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying our proprietary technologies to our Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms.
We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. 104 Table of Contents Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.
Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.
The increase of $2.5 million was primarily due to the achievement of a developmental milestone related to the First Collaboration Target under the Merck Agreement in June 2024 offset by a decrease in full-time equivalent hours incurred in the performance of research services required under the Merck Agreement.
The decrease of $0.6 million was primarily due to an increase in milestone revenue under the Merck Agreement, offset by the completion of our research activities under the Merck Agreement in August 2024.
We are also generating a number of unnamed 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. We were incorporated in June 2017.
We are also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development, including a PSMA x CD28 TRACIr designed to enhance T cell activation and durability of JANX007in patients with mCRPC. We were incorporated in June 2017.
Other Income Other income was $29.9 million and $14.7 million for the years ended December 31, 2024 and 2023, respectively. The increase of $15.2 million was due to an increased cash and cash equivalents balance resulting in increased interest income.
This was offset by a decrease in stock-based compensation of $2.5 million as a result of incremental stock-based compensation expense taken in 2024 due to the modification of a former director and executive officer’s equity awards. Other Income Other income was $44.0 million and $29.9 million for the years ended December 31, 2025 and 2024, respectively.
Removed
From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not currently a party to any material legal proceedings.
Added
This group identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment and our risk profile using various methods including, for example manual and automated tools, subscribing to reports and services that identify cybersecurity threats, evaluating our and our industry’s risk profile, evaluating threats reported to us and coordinating with law enforcement about such threats as may be appropriate, conducting internal and external audits, conducting internal threat assessments to evaluate for both internal and external threats, having third parties conduct threat assessments, and conducting vulnerability assessments designed to identify vulnerabilities.
Removed
In December 2024 we announced updated interim clinical data for JANX007 which displayed meaningful and prolonged PSA drops, encouraging anti-tumor activity, a favorable safety profile including CRS and treatment-related adverse events (TRAEs) primarily limited to Cycle 1 and lower grades, and PK consistent with the TRACTr mechanism-of-action.
Added
At the same location, we have a separate sublease for additional office space pursuant to a lease agreement which commenced in August 2025 and expires in January 2028. We believe that our existing facilities are adequate for the foreseeable future.
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Our second clinical candidate, JANX008, is an epidermal growth factor receptor or EGFR-TRACTr 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.
Added
Prior to that date, there was no public market for our common stock. Holders of Common Stock As of February 24, 2026, there were 60,831,656 shares of common stock issued and held by approximately 16 stockholders of record.
Removed
The first patient for this trial was dosed in April 2023 and in February 2024 we announced positive early data for JANX008 that displayed anti-tumor activity in multiple tumor types with low-grade CRS and predominantly low-grade TRAEs.
Added
Our initial focus is on developing a novel class of TRACTr therapeutics designed to target clinically validated TCE drug targets, while overcoming the liabilities associated with prior generations of TCEs.
Removed
For example, in 2023, the Federal Deposit Insurance Corporation took control and was appointed receiver of certain financial institutions.
Added
Our ARM platform builds upon our expertise to redesign bispecific T cell engagers to address the limitations of conventional approaches in autoimmune diseases and oncology. The platform is designed to enable controlled T cell activation and expansion followed by contraction, with the goal of achieving deep and durable target cell depletion while improving safety and convenience.
Removed
If other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition.
Added
We have initiated a Phase 1 clinical study of our CD19-ARM program (JANX011), which is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JANX011 in healthy volunteers. JANX011 is being developed for autoimmune diseases, and the initiation of this study represents an important step in the advancement of our ARM platform from preclinical development into the clinic.
Removed
(formerly COI Pharmaceuticals, Inc.) In January 2021, we entered into a Support Services Agreement (the 2021 Support Services Agreement) with Avalon BioVentures, Inc. (Avalon) that outlines the terms of services provided by Avalon to us, as well as the fees charged for such services.
Added
We anticipate that our research and development expenses will substantially increase for the foreseeable future as we continue the development of our TRACTr, TRACIr and ARM platforms and the discovery and development of product candidates under our TRACTr, TRACIr and ARM platforms.
Removed
Avalon is a shared service company that provides certain back-office and administrative and research and development support services, including facilities support, to the portfolio companies of Avalon Ventures, an entity that beneficially owned greater than 5% of our outstanding capital stock until November 2024. The amounts paid to Avalon include support service fees or mark-ups of up to 5%.
Added
We will need to raise substantial additional capital in the future.
Removed
General and Administrative General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, finance and other administrative functions.
Added
See Note 3 to our audited financial statements appearing in Part II, Item 8 of this Annual Report on Form 10-K for additional information. In June 2025, we entered into a noncancelable agreement to sublease additional office space in San Diego, California through January 2028.
Removed
Food and Drug Administration (FDA) in May 2022 and January 2023, respectively. As a result, we have separated direct costs for the development of JANX007 and JANX008 from preclinical stage programs and other direct unallocated costs for the years ended December 31, 2024 and 2023.
Removed
We will further separate direct costs related to our other programs as future IND applications are cleared by the FDA. Research and development expenses were $68.4 million and $54.9 million for the years ended December 31, 2024 and 2023, respectively.
Removed
The shares of common stock were sold at a price of $12.46 per share and the pre-funded common stock warrants were sold at a price of $12.459 per pre-funded common stock warrant, resulting in gross proceeds of $59.0 million.
Removed
Fees related to the offering included underwriting discounts, commissions, and offering expenses in the aggregate amount of $2.5 million, resulting in net proceeds of $56.5 million. In March 2024, we closed an underwritten offering of 5,397,301 shares of our common stock and pre-funded warrants to purchase 1,935,483 shares of common stock at an exercise price of $0.001 per share.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeA reconciliation of the Company’s income tax expense (benefit) to the amount computed by applying the federal statutory income tax rate is summarized as follows (in thousands): Year Ended December 31, 2024 2023 2022 Expected tax benefit computed at federal statutory rate $ ( 14,489 ) $ ( 12,242 ) $ ( 13,242 ) State income taxes, net of federal tax benefit ( 3,437 ) ( 2,827 ) ( 3,754 ) Permanent differences 111 86 ( 48 ) Equity compensation ( 6,448 ) 1,289 686 Officer's compensation 6,449 2,192 1,261 Research and development credits ( 6,251 ) ( 4,300 ) ( 2,930 ) Reserve for uncertain tax positions 1,534 1,058 715 Other 385 124 80 Change in valuation allowance 22,146 14,620 17,232 Income tax expense (benefit) $ — $ — $ — Significant components of the Company’s net deferred tax assets are summarized as follows (in thousands): 130 Table of Contents Janux Therapeutics, Inc.
Biggest changeNotes to Financial Statements - (Continued) A reconciliation of the Company’s income tax expense (benefit) to the amount computed by applying the federal statutory income tax rate is summarized as follows (in thousands, except %): Year Ended December 31, 2025 2024 2023 Amount Percent Amount Percent Amount Percent Income taxes (benefit) at statutory rates $ ( 23,861 ) 21.0 % $ ( 14,489 ) 21.0 % $ ( 12,242 ) 21.0 % State and local income taxes, net of federal benefit (1) ( 415 ) 0.4 % ( 406 ) 0.6 % ( 217 ) 0.4 % Foreign tax effects — 0.0 % — 0.0 % — 0.0 % Effect of changes in tax laws or rates enacted in the current period — 0.0 % — 0.0 % — 0.0 % Effect of cross-border tax laws — 0.0 % — 0.0 % — 0.0 % Tax credits R&D Credits ( 3,695 ) 3.3 % ( 4,513 ) 6.5 % ( 3,367 ) 5.8 % Change in valuation allowances 21,765 ( 19.2 %) 17,762 ( 25.7 %) 11,078 ( 19.0 %) Nontaxable or nondeductible items Equity compensation 1,518 ( 1.3 %) ( 4,112 ) 6.0 % 1,324 ( 2.3 %) Officer's compensation 3,293 ( 2.9 %) 4,113 ( 6.0 %) 2,157 ( 3.7 %) Permanent Differences 57 0.0 % 111 ( 0.2 %) 86 ( 0.1 %) Changes in unrecognized tax benefits 1,338 ( 1.3 %) 1,534 ( 2.2 %) 1,058 ( 1.9 %) Other, net — 0.0 % — 0.0 % 123 ( 0.2 %) Income tax expense (benefit) $ — 0.0 % $ — 0.0 % $ — 0.0 % (1) State taxes in California made up the majority (greater than 50%) of the tax effect in this category for 2025, 2024 and 2023 .
Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the Company’s obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones.
Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the Company’s obligation to make payments under these contracts depends on factors such as the successful enrollment of patients, treatment of patients, or the completion of other clinical trial milestones.
Liabilities from operating leases are included in current portion of operating lease liabilities, and operating lease liabilities, net of current portion on the accompanying balance sheets. The Company does not have any financing leases. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet.
Liabilities from operating leases are included in current portion of operating lease liabilities, and operating lease liabilities, net of current portion on the accompanying balance sheets. The Company does not have any financing leases. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheets.
Realized gains and losses are calculated using the specific identification method and recorded as interest income. 118 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) The following tables summarize short-term investments (in thousands): As of December 31, 2024 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
Realized gains and losses are calculated using the specific identification method and recorded as interest income. 118 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) The following tables summarize short-term investments (in thousands): As of December 31, 2025 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
Accrued interest receivable is included in prepaid expenses and other current assets in the accompanying balance sheets. Contractual maturities of available-for-sale debt securities are as follows (in thousands): As of December 31, 2024 Due in 1 Year or Less Due Between 1 and 3 Years U.S.
Accrued interest receivable is included in prepaid expenses and other current assets in the accompanying balance sheets. Contractual maturities of available-for-sale debt securities are as follows (in thousands): As of December 31, 2025 Due in 1 Year or Less Due Between 1 and 3 Years U.S.
If ownership changes have occurred or occurs in the future, the amount of remaining tax attribute carryforwards available to offset taxable income and income tax expense in future years may be restricted or eliminated. If eliminated, the related asset would be removed from deferred tax assets with a corresponding reduction in the valuation allowance.
If ownership changes have occurred or occur in the future, the amount of remaining tax attribute carryforwards available to offset taxable income and income tax expense in future years may be restricted or eliminated. If eliminated, the related asset would be removed from deferred tax assets with a corresponding reduction in the valuation allowance.
Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker ("CODM"), or decision-making group, in making decisions on how to allocate resources and assess performance.
Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in making decisions on how to allocate resources and assess performance.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organization of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2024, our internal control over financial reporting was effective.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organization of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2025, our internal control over financial reporting was effective.
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
The Company is also subject to credit risk from its accounts receivable. The Company generally does not perform evaluations of customers’ financial condition and generally does not require collateral. For the years ended December 31, 2024 , 2023 and 2022, all of the Company’s revenue related to a single customer.
The Company is also subject to credit risk from its accounts receivable. The Company generally does not perform evaluations of customers’ financial condition and generally does not require collateral. For the years ended December 31, 2025, 2024 and 2023 , all of the Company’s revenue related to a single customer.
Use of Estimates The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). The preparation of the Company’s financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes.
Use of Estimates The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP” ). The preparation of the Company’s financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes.
In general, an "ownership change," as defined by Section 382 of the Code, results from a transaction, or series of transactions over a three-year period, resulting in an ownership change of more than 50% of the outstanding common stock of a company by certain stockholders or public groups.
In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction, or series of transactions over a three-year period, resulting in an ownership change of more than 50% of the outstanding common stock of a company by certain stockholders or public groups.
Cash and cash equivalents include cash in readily available checking accounts and money market funds. Restricted Cash Restricted cash consists of a money market account securing a standby letter of credit issued in connection with the Company’s Torrey Plaza operating lease (as defined and described in Note 3).
Cash and cash equivalents include cash in readily available checking accounts, money market funds and commercial paper. Restricted Cash Restricted cash consists of a money market account securing a standby letter of credit issued in connection with the Company’s Torrey Plaza operating lease (as defined and described in Note 3).
Stock-Based Compensation Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options, restricted stock units and employee stock purchase plan rights, recognized on a straight-line basis over the requisite service period for stock options and restricted stock units, and over the respective offering period for employee stock purchase plan rights.
Stock-Based Compensation Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options, restricted stock units (“RSUs”) and employee stock purchase plan rights, recognized on a straight-line basis over the requisite service period for stock options and RSUs, and over the respective offering period for employee stock purchase plan rights.
Opinion on Internal Control Over Financial Reporting We have audited Janux Therapeutics Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Janux Therapeutics, Inc.
Opinion on Internal Control Over Financial Reporting We have audited Janux Therapeutics Inc.’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Janux Therapeutics, Inc.
All other future potential milestone payments are considered constrained as of December 31, 2024 as they are uncertain in nature and highly dependent on factors outside of the Company’s control until the underlying events occur or the associated approvals are received.
All other future potential milestone payments are considered constrained as of December 31, 2025 as they are uncertain in nature and highly dependent on factors outside of the Company's control until the underlying events occur or the associated approvals are received.
The effectiveness of our internal control over financial reporting as of December 31, 2024 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report, which is included herein.
The effectiveness of our internal control over financial reporting as of December 31, 2025 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report, which is included herein.
In August 2024, and in connection with the resignation of a former executive officer, the compensation committee of the board of directors approved the following modifications to the terms of the former officer’s outstanding equity awards as defined within a transition and consulting agreement with the former officer (the “Transition Agreement”): (a) acceleration of the vesting of unvested stock options such that the number of options that would have vested through June 30, 2026, are vested and exercisable, with such acceleration deemed effective as of December 31, 2024, subject to service conditions described within the Transition Agreement; and (b) extension of the post-termination exercise period for outstanding options until the earlier of December 31, 2027 or the original expiration date of such options, subject to the Company’s ability to take any actions permitted under the Plans, as applicable.
In August 2024, and in connection with the resignation of a former executive officer, the compensation committee of the board of directors approved the following modifications to the terms of the former officer’s outstanding equity awards: (a) acceleration of the vesting of unvested stock options such that the number of options that would have vested through June 30, 2026, became vested and exercisable, with such acceleration deemed effective as of December 31, 2024, subject to service conditions described within a transition and consulting agreement with the former officer; and (b) extension of the post-termination exercise period for outstanding options until the earlier of December 31, 2027 or the original expiration date of such options, subject to the Company’s ability to take any actions permitted under the Plans, as applicable.
(the Company) as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).
(the Company) as of December 31, 2025 and 2024, the related statements of operations and comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”).
Evaluation of Disclosure Controls and Procedures As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management with the participation of our Chief Executive Officer (principal executive and financial officer), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024.
Evaluation of Disclosure Controls and Procedures As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management with the participation of our Chief Executive Officer (principal executive and financial officer), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025.
There were no available-for-sale debt securities in a continuous unrealized loss position for 12 months or longer at December 31, 2024. 119 Table of Contents Janux Therapeutics, Inc.
There were no available-for-sale debt securities in a continuous unrealized loss position for 12 months or longer at December 31, 2025 and 2024 . 119 Table of Contents Janux Therapeutics, Inc.
Qualitative factors may include a credit downgrade, severity of the decline in fair value below amortized cost and other adverse conditions related specifically to the security, as well as the intent to sell the security, or whether the Company will “more likely than not” be required to sell the security before recovery of its amortized cost basis.
Qualitative factors may include a credit downgrade, severity of the decline in fair value below amortized cost and other adverse conditions related specifically to the security, as well as the intent to sell the security, or whether the Company will “more likely than not” be required to sell the security before recovery of its amortized cost bas is.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer (principal executive and financial officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer (principal executive and financial officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 27, 2025 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 26, 2026 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the balance sheets of the Company as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and our report dated February 27, 2025 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the balance sheets of the Company as of December 31, 2025 and 2024, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and our report dated February 26, 2026 expressed an unqualified opinion thereon.
The fair value of assets classified within Level 1 is based on quoted prices in active markets as provided by the Company’s investment managers. The fair value of short-term investments classified within Level 2 is based on standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers.
The fair value of assets classified within Level 1 is based on quoted prices in active markets as provided by the Company’s investment managers. The fair value of assets classified within Level 2 is based on standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers.
There was no activity from the Sale Agreement during the year ended December 31, 2024. As of December 31, 2024 , $ 150.0 million of common stock remained available for sale under the Sale Agreement.
There was no activity from the Sale Agreement during the year ended December 31, 2025. As of December 31, 2025 , $ 150.0 million of common stock remained available for sale under the Sale Agreement.
Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock awards, performance cash awards and other forms of stock awards to employees, directors and consultants.
Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, performance stock awards, performance cash awards and other forms of stock awards to employees, directors and consultants.
The Torrey Plaza Lease provides an option to extend the term of the lease for a period of 5 years beyond the initial term, which the Company is not reasonably certain to exercise and therefore was not considered in determining the ROU assets and lease liabilities balance.
The Torrey Plaza Lease provides an option to extend the term of the lease for a period of 5 years beyond the initial term, which the Company is not reasonably certain to exercise and therefore was not considered in determining the ROU assets and lease liabilities balanc e.
The Company recognized $ 10.6 million, $ 8.1 million and $ 8.6 million of revenue under the Merck Agreement for the years ended December 31, 2024, 2023 and 2022, respectively. The Company's performance obligations related to the Collaboration Targets were completed as of December 31, 2024 . 6.
The Company recognized $ 10.0 million, $ 10.6 million and $ 8.1 million of revenue under the Merck Agreement for the years ended December 31, 2025, 2024 and 2023, respectively. The Company's performance obligations related to the Collaboration Targets were completed as of December 31, 2025 . 6.
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria.
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
Liquidity and Capital Resources From its inception through December 31, 2024, the Company has devoted substantially all its efforts to organizing and staffing, business planning, raising capital and developing its TRACTr and TRACIr therapeutic platforms and assets.
Liquidity and Capital Resources From its inception through December 31, 2025, the Company has devoted substantially all its efforts to organizing and staffing, business planning, raising capital and developing its TRACTr, TRACIr and ARM therapeutic platforms and assets.
Additionally, we established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. We believe that should a 10.0% change in interest rates were to have occurred on December 31, 2024, this change would not have had a material effect on the fair value of our investment portfolio as of that date.
Additionally, we established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. We believe that if a 10.0% change in interest rates had occurred on December 31, 2025, this change would not have had a material effect on the fair value of our investment portfolio as of that date.
The Company has excluded weighted-average unvested shares of 3,645 shares, 27,458 shares and 182,194 shares from the weighted-average number of shares of common stock outstanding for the years ended December 31, 2024, 2023 and 2022, respectively.
The Company has excluded weighted-average unvested shares of 3,645 shares and 27,458 shares from the weighted-average number of shares of common stock outstanding for the years ended December 31, 2024 and 2023, respectively.
The Company did no t have any RSU activity during the year ended December 31, 2023. 2021 Employee Stock Purchase Plan In June 2021, the Company adopted the 2021 Employee Stock Purchase Plan (the “ESPP”), which became effective on June 10, 2021.
The Company did not have any RSU activity during the year ended December 31, 2023. 2021 Employee Stock Purchase Plan In June 2021, the Company adopted the 2021 Employee Stock Purchase Plan (the “ESPP”), which became effective on June 10, 2021.
Federal NOL carryforwards totaling $ 0.5 million begin to expire in 2037 , unless previously utilized, and federal NOL carryforwards of $ 65.7 million generated after 2017, may be carried forward indefinitely but can only be utilized to offset 80 % of future taxable income.
Federal NOL carryforwards totaling $ 0.5 million begin to expire in 2037 , unless previously utilized, and federal NOL carryforwards of $ 138.4 million generated after 2017, may be carried forward indefinitely but can only be utilized to offset 80 % of future taxable income.
Notes to Financial Statements - (Continued) Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2023: Assets: Cash equivalents: Money market funds $ 14,751 $ 14,751 $ — $ — Total cash equivalents 14,751 14,751 — — Short-term investments: U.S.
Notes to Financial Statements - (Continued) Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2024: Assets: Cash equivalents: Money market funds $ 427,959 $ 427,959 $ — $ — Total cash equivalents 427,959 427,959 — — Short-term investments: U.S.
The incremental stock-based compensation expense resulting from these modifications recognized during the year ended December 31, 2024 was $ 8.7 million.
The incremental stock-based compensation expense resulting from these modifications recognized during the year ended December 31, 2024 was $ 8.7 million. There was no stock-based compensation expense resulting from these modifications recognized during the year ended December 31, 2025.
The Company has incurred net losses and negative cash flows from operations since inception and had an accumulated deficit of $ 237.8 million as of December 31, 2024. The Company has a limited operating history, has not generated any product revenue, and the sales and income potential of its business is unproven.
The Company has incurred net losses and negative cash flows from operations since inception and had an accumulated deficit of $ 351.4 million as of December 31, 2025. The Company has a limited operating history, has not generated any product revenue, and the sales and income potential of its business is unproven.
An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Impairment losses recognized through December 31, 2024 were not material.
An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. For the years ended December 31, 2025, 2024 and 2023, impairment losses recognized were not material.
Clinical Trial Expenses The Company makes payments in connection with its clinical trials under contracts with contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows.
Actual results could differ from the Company’s estimates. Clinical Trial Expenses The Company makes payments in connection with its clinical trials under contracts with contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows.
In June 2024, a developmental milestone of $ 7.5 million related to the First Collaboration Target was achieved, at which time the Company recognized the associated revenue.
In June 2024, a developmental milestone of $ 7.5 million related to the First Collaboration Target was achieved, at which time the Company recognized the associated revenue. In August 2025, a developmental milestone of $ 10.0 million related to the First Collaboration Target was achieved, at which time the Company recognized the associated revenue.
In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service.
Notes to Financial Statements - (Continued) Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service.
All revenue recognized to date has been derived from the Company’s existing collaboration agreement with Merck (as defined and described in Note 5).
All revenue recognized to date has been derived from the Company’s existing collaboration agreement with Merck Sharp & Dohme Corp (“Merck” ) (as defined and described in Note 5).
The total intrinsic value of stock options exercised for the years ended December 31, 2024 , 2023 and 2022 was $ 45.6 million , $ 1.9 million and $ 0.1 million, respectively.
The total intrinsic value of stock options exercised for the years ended December 31, 2025, 2024 and 2023 was $ 6.7 million , $ 45.6 million and $ 1.9 million, respectively.
For the years ended December 31, 2024 , 2023 and 2022, stock-based compensation expense related to the ESPP was $ 0.8 million, $ 0.9 million and $ 0.6 million, respectively .
For the years ended December 31, 2025, 2024 and 2023 , stock-based compensation expense related to the ESPP was $ 1.1 million, $ 0.8 million and $ 0.9 million, respectively.
The Company 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”) and Tumor Activated Immunomodulator (“TRACIr”) platforms to better treat patients suffering from cancer.
The Company 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 to better treat patients suffering from cancer and autoimmune disease.
The assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants under the Plans were as follows: Year Ended December 31, 2024 2023 2022 Risk-free interest rate 3.6 % – 4.6 % 3.5 % – 4.7 % 1.5 % – 4.2 % Expected volatility 83 % – 106 % 82 % – 87 % 81 % – 85 % Expected term (in years) 5.3 – 6.1 5.3 – 6.1 5.3 – 6.1 Expected dividend yield — — — Risk-free interest rate .
The assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants under the Plans were as follows: Year Ended December 31, 2025 2024 2023 Risk-free interest rate 3.8 % – 4.4 % 3.6 % – 4.6 % 3.5 % – 4.7 % Expected volatility 97 % – 104 % 83 % – 106 % 82 % – 87 % Expected term (in years) 5.3 – 10.0 5.3 – 6.1 5.3 – 6.1 Expected dividend yield — — — Risk-free interest rate .
Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, including pre-funded common stock warrants that were issued in underwritten offerings (Note 4), without consideration for potentially dilutive securities.
Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, including pre-funded common stock warrants that were issued in underwritten offerings and vested RSUs for which deferred settlement was elected (Note 4), without consideration for potentially dilutive securities.
As of December 31, 2024 , total unrecognized stock-based compensation cost associated with option grants was $ 33.9 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.2 years.
As of December 31, 2025 , total unrecognized stock-based compensation cost associated with option grants was $ 57.6 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.3 years.
Operating lease expense included in the measurement of lease liabilities for years ended December 31, 2024 , 2023 and 2022 was $ 3.4 million, $ 3.4 million and $ 2.8 million, respectively.
Operating lease expense included in the measurement of lease liabilities for years ended December 31, 2025, 2024 and 2023 was $ 3.6 million, $ 3.4 million and $ 3.4 million, respectively.
The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2024: Assets: Cash equivalents: Money market funds $ 427,959 $ 427,959 $ — $ — Total cash equivalents 427,959 427,959 — — Short-term investments: U.S.
The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2025: Assets: Cash equivalents: Money market funds $ 41,085 $ 41,085 $ — $ — Commercial paper 9,478 9,478 — Total cash equivalents 50,563 41,085 9,478 — Short-term investments: U.S.
The Company recognizes forfeitures for all awards as they occur. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements.
Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements.
Clinical Trial Expenses Description of the Matter The Company recorded research and development expenses of $68.4 million for the year ended December 31, 2024, which includes clinical trial expenses. Clinical trial expenses are expensed as incurred.
Clinical Trial Expenses Description of the Matter The Company recorded research and development expenses of $125.9 million for the year ended December 31, 2025, which includes clinical trial expenses. Clinical trial expenses are expensed as incurred.
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the accompanying balance sheets that sum to the amounts shown in the statements of cash flows (in thousands): December 31, 2024 2023 Cash and cash equivalents $ 430,605 $ 19,205 Restricted cash 816 816 Total cash and cash equivalents and restricted cash $ 431,421 $ 20,021 Short-Term Investments Short-term investments consist of U.S.
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the accompanying balance sheets that sum to the amounts shown in the statements of cash flows (in thousands): December 31, 2025 2024 Cash and cash equivalents $ 52,334 $ 430,605 Restricted cash 816 816 Total cash and cash equivalents and restricted cash $ 53,150 $ 431,421 Short-Term Investments Short-term investments consist of U.S.
Notes to Financial Statements - (Continued) product-by-product and country-by-country basis, for licensed products not covered by patent claims, or that require Merck to obtain a license to obtain a license to third-party intellectual property in order to commercialize the licensed products, or that are subject to compulsory licensing.
Such royalties are subject to reduction, on a product-by-product and country-by-country basis, for licensed products not covered by patent claims, or that require Merck to obtain a license to obtain a license to third-party intellectual property in order to commercialize the licensed products, or that are subject to compulsory licensing.
Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities.
Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for 121 Table of Contents Janux Therapeutics, Inc.
The peer group was developed based on companies in the biotechnology industry. As sufficient historical data is now available for the Company’s stock price, the Company is currently applying and will continue to apply the volatility of its own stock price in determining volatility. 127 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) Expected term .
The peer group was developed based on companies in the biotechnology industry. As sufficient historical data is now available for the Company’s stock price, the Company is currently applying and will continue to apply the volatility of its own stock price in determining volatility. Expected term .
Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service.
Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the 120 Table of Contents Janux Therapeutics, Inc.
If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their 122 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of the awards. Expected volatility.
The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of the awards. 127 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) Expected volatility.
Statem ents of Cash Flows (in thousands) Year Ended December 31, 2024 2023 2022 Cash flows from operating activities Net loss $ ( 68,994 ) $ ( 58,293 ) $ ( 63,059 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 2,060 1,955 841 Stock-based compensation 33,020 20,005 17,203 Accretion of discounts on investments, net ( 10,585 ) ( 7,688 ) ( 2,183 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 3,280 ) 210 ( 3,369 ) Other long-term assets ( 375 ) ( 1,119 ) ( 1,270 ) Accounts payable 1,584 277 ( 294 ) Accrued expenses 4,426 ( 678 ) 4,156 Deferred revenue ( 1,705 ) ( 5,922 ) 1,764 Operating lease right-of-use assets and liabilities, net 35 678 3,289 Net cash used in operating activities ( 43,814 ) ( 50,575 ) ( 42,922 ) Cash flows from investing activities Purchases of property and equipment ( 359 ) ( 1,850 ) ( 6,445 ) Purchases of short-term investments ( 470,577 ) ( 317,344 ) ( 294,389 ) Maturities of short-term investments 212,915 278,000 359,100 Net cash provided by (used in) investing activities ( 258,021 ) ( 41,194 ) 58,266 Cash flows from financing activities Proceeds from exercise of common stock options and employee stock purchase plan 14,968 3,018 500 Proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs 698,267 56,530 — Net cash provided by financing activities 713,235 59,548 500 Net increase (decrease) in cash, cash equivalents and restricted cash 411,400 ( 32,221 ) 15,844 Cash, cash equivalents and restricted cash – beginning of year 20,021 52,242 36,398 Cash, cash equivalents and restricted cash – end of period $ 431,421 $ 20,021 $ 52,242 Supplemental disclosure of noncash investing and financing activities Unpaid property and equipment $ 6 $ 132 $ 109 Unpaid issuance costs $ 347 $ — $ — Vesting of restricted common stock $ 20 $ 149 $ 1,034 Unrealized gain (loss) on available-for-sale securities, net $ 1,498 $ 2,200 $ ( 1,265 ) Operating lease liabilities arising from right-of-use assets $ — $ — $ 23,422 See accompanying notes. 115 Table of Contents Janux Therapeutics, Inc.
Statem ents of Cash Flows (in thousands) Year Ended December 31, 2025 2024 2023 Cash flows from operating activities Net loss $ ( 113,625 ) $ ( 68,994 ) $ ( 58,293 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 2,029 2,060 1,955 Stock-based compensation 40,221 33,020 20,005 Accretion of discounts on investments, net ( 17,574 ) ( 10,585 ) ( 7,688 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 827 ) ( 3,280 ) 210 Other long-term assets 276 ( 375 ) ( 1,119 ) Accounts payable 977 1,584 277 Accrued expenses 6,290 4,426 ( 678 ) Deferred revenue — ( 1,705 ) ( 5,922 ) Operating lease right-of-use assets and liabilities, net ( 2 ) 35 678 Net cash used in operating activities ( 82,235 ) ( 43,814 ) ( 50,575 ) Cash flows from investing activities Purchases of property and equipment ( 1,043 ) ( 359 ) ( 1,850 ) Purchases of short-term investments ( 705,222 ) ( 470,577 ) ( 317,344 ) Maturities of short-term investments 405,284 212,915 278,000 Net cash used in investing activities ( 300,981 ) ( 258,021 ) ( 41,194 ) Cash flows from financing activities Proceeds from exercise of common stock options and employee stock purchase plan 5,292 14,968 3,018 Proceeds from the issuance of common stock and pre-funded common stock warrants, net of issuance costs ( 347 ) 698,267 56,530 Net cash provided by financing activities 4,945 713,235 59,548 Net increase (decrease) in cash, cash equivalents and restricted cash ( 378,271 ) 411,400 ( 32,221 ) Cash, cash equivalents and restricted cash – beginning of year 431,421 20,021 52,242 Cash, cash equivalents and restricted cash – end of period $ 53,150 $ 431,421 $ 20,021 Supplemental disclosure of noncash investing and financing activities Unpaid property and equipment $ — $ 6 $ 132 Unpaid issuance costs $ — $ 347 $ — Vesting of restricted common stock $ — $ 20 $ 149 Unrealized gain on available-for-sale securities, net $ 2,153 $ 1,498 $ 2,200 Operating lease liabilities arising from right-of-use assets $ 943 $ — $ — See accompanying notes. 115 Table of Contents Janux Therapeutics, Inc.
The Company estimates the fair value of stock options and employee stock purchase plan rights using the Black-Scholes option pricing model. The fair value of restricted stock units is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant.
The Company estimates the fair value of stock options and employee stock purchase plan rights using the Black-Scholes option pricing model. The fair value of RSUs is based on the closing price of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant. The Company recognizes forfeitures for all awards as they occur.
Statements of Stockholders’ Equity (in thousands, except share data) Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Capital Income (Loss) Deficit Equity Balance at December 31, 2021 41,243,137 $ 41 $ 413,967 $ ( 270 ) $ ( 47,411 ) 366,327 Exercise of common stock options 7,405 — 1 — — 1 Shares issued under employee stock purchase plan 54,299 — 499 — — 499 Vesting of restricted shares 311,419 1 1,033 — — 1,034 Stock-based compensation — — 17,203 — — 17,203 Unrealized loss on available-for-sale securities, net — — — ( 1,265 ) — ( 1,265 ) Net loss — — — — ( 63,059 ) ( 63,059 ) Balance at December 31, 2022 41,616,260 $ 42 $ 432,703 $ ( 1,535 ) $ ( 110,470 ) $ 320,740 Issuance of common stock and pre-funded common stock warrants, net of $ 2,495 of issuance costs 4,153,717 4 56,526 — — 56,530 Exercise of pre-funded common stock warrants 80,257 — — — — — Exercise of common stock options 253,545 — 2,246 — — 2,246 Shares issued under employee stock purchase plan 90,574 — 772 — — 772 Vesting of restricted shares 58,087 — 149 — — 149 Stock-based compensation — — 20,005 — — 20,005 Unrealized gain on available-for-sale securities, net — — — 2,200 — 2,200 Net loss — — — — ( 58,293 ) ( 58,293 ) Balance at December 31, 2023 46,252,440 $ 46 $ 512,401 $ 665 $ ( 168,763 ) $ 344,349 Issuance of common stock and pre-funded common stock warrants, net of $ 45,554 of issuance costs 11,548,094 12 697,908 — — 697,920 Exercise of common stock options 1,152,192 1 14,175 — — 14,176 Issuance of common stock upon vesting of restricted stock units 2,500 — — — — — Shares issued under employee stock purchase plan 99,061 — 792 — — 792 Vesting of restricted shares 10,319 — 20 — — 20 Stock-based compensation — — 33,020 — — 33,020 Unrealized gain on available-for-sale securities, net — — — 1,498 — 1,498 Net loss — — — — ( 68,994 ) ( 68,994 ) Balance at December 31, 2024 59,064,606 $ 59 $ 1,258,316 $ 2,163 $ ( 237,757 ) $ 1,022,781 See accompanying notes. 114 Table of Contents Janux Therapeutics, Inc.
Statements of Stockholders’ Equity (in thousands, except share data) Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Capital Income (Loss) Deficit Equity Balance at December 31, 2022 41,616,260 $ 42 $ 432,703 $ ( 1,535 ) $ ( 110,470 ) 320,740 Issuance of common stock and pre-funded common stock warrants, net of $ 2,495 of issuance costs 4,153,717 4 56,526 — — 56,530 Exercise of pre-funded common stock warrants 80,257 — — — — — Exercise of common stock options 253,545 — 2,246 — — 2,246 Shares issued under employee stock purchase plan 90,574 — 772 — — 772 Vesting of restricted shares 58,087 — 149 — — 149 Stock-based compensation — — 20,005 — — 20,005 Unrealized gain on available-for-sale securities, net — — — 2,200 — 2,200 Net loss — — — — ( 58,293 ) ( 58,293 ) Balance at December 31, 2023 46,252,440 $ 46 $ 512,401 $ 665 $ ( 168,763 ) $ 344,349 Issuance of common stock and pre-funded common stock warrants, net of $ 45,554 of issuance costs 11,548,094 12 697,908 — — 697,920 Exercise of common stock options 1,152,192 1 14,175 — — 14,176 Issuance of common stock upon settlement of restricted stock units 2,500 — — — — — Shares issued under employee stock purchase plan 99,061 — 792 — — 792 Vesting of restricted shares 10,319 — 20 — — 20 Stock-based compensation — — 33,020 — — 33,020 Unrealized gain on available-for-sale securities, net — — — 1,498 — 1,498 Net loss — — — — ( 68,994 ) ( 68,994 ) Balance at December 31, 2024 59,064,606 $ 59 $ 1,258,316 $ 2,163 $ ( 237,757 ) $ 1,022,781 Exercise of pre-funded common stock warrants 775,698 1 ( 1 ) — — — Exercise of common stock options 401,110 — 4,070 — — 4,070 Issuance of common stock upon settlement of restricted stock units 15,588 — — — — — Shares issued under employee stock purchase plan 127,281 — 1,222 — — 1,222 Stock-based compensation — — 40,221 — — 40,221 Unrealized gain on available-for-sale securities, net — — — 2,153 — 2,153 Net loss — — — ( 113,625 ) ( 113,625 ) Balance at December 31, 2025 60,384,283 $ 60 $ 1,303,828 $ 4,316 $ ( 351,382 ) $ 956,822 See accompanying notes. 114 Table of Contents Janux Therapeutics, Inc.
The Company’s operating leases are subject to additional variable charges, including common area maintenance, property taxes, property insurance and other variable costs. Given the variable nature of such costs, they are recognized as expense as incurred.
Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company’s operating leases are subject to additional variable charges, including common area maintenance, property taxes, property insurance and other variable costs. Given the variable nature of such costs, they are recognized as expense as incurred.
State NOL carryforwards totaling $ 167.6 million begin to expire in 2037 , unless previously utilized. In addition, the Company also has federal and state research and development ("R&D") credit carryforwards totaling $ 10.9 million and $ 5.3 million respectively. The federal R&D credit carryforwards will begin to expire in 2037 unless previously utilized.
State NOL carryforwards totaling $ 182.9 million begin to expire in 2037 , unless previously utilized. In addition, the Company also has federal and state research and development ( “R&D” ) credit carryforwards totaling $ 14.6 million and $ 7.4 million respectively. The federal R&D credit carryforwards will begin to expire in 2037 unless previously utilized.
Statemen ts of Operations and Comprehensive Loss (in thousands, except share and per share data) Year Ended December 31, 2024 2023 2022 Collaboration revenue $ 10,588 $ 8,083 $ 8,612 Operating expenses: Research and development 68,388 54,922 53,441 General and administrative 41,047 26,140 22,262 Total operating expenses 109,435 81,062 75,703 Loss from operations ( 98,847 ) ( 72,979 ) ( 67,091 ) Other income: Interest income 29,853 14,686 4,032 Total other income 29,853 14,686 4,032 Net loss $ ( 68,994 ) $ ( 58,293 ) $ ( 63,059 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net 1,498 2,200 ( 1,265 ) Comprehensive loss $ ( 67,496 ) $ ( 56,093 ) $ ( 64,324 ) Net loss per common share, basic and diluted $ ( 1.28 ) $ ( 1.32 ) $ ( 1.52 ) Weighted-average shares of common stock outstanding, basic and diluted 53,751,480 44,016,283 41,469,631 See accompanying notes. 113 Table of Contents Janux Therapeutics, Inc.
Statemen ts of Operations and Comprehensive Loss (in thousands, except share and per share data) Year Ended December 31, 2025 2024 2023 Collaboration revenue $ 10,000 $ 10,588 $ 8,083 Operating expenses: Research and development 125,896 68,388 54,922 General and administrative 41,771 41,047 26,140 Total operating expenses 167,667 109,435 81,062 Loss from operations ( 157,667 ) ( 98,847 ) ( 72,979 ) Other income: Interest income 44,042 29,853 14,686 Total other income 44,042 29,853 14,686 Net loss $ ( 113,625 ) $ ( 68,994 ) $ ( 58,293 ) Other comprehensive gain (loss): Unrealized gain on available-for-sale securities, net 2,153 1,498 2,200 Comprehensive loss $ ( 111,472 ) $ ( 67,496 ) $ ( 56,093 ) Net loss per common share, basic and diluted $ ( 1.83 ) $ ( 1.28 ) $ ( 1.32 ) Weighted-average shares of common stock outstanding, basic and diluted 61,966,999 53,751,480 44,016,283 See accompanying notes. 113 Table of Contents Janux Therapeutics, Inc.
As of December 31, 2024 , total unrecognized stock-based compensation expense related to the ESPP was $ 0.6 million, which is expected to be recognized over a remaining weighted-average period of approximately 1.3 years.
As of December 31, 2025 , total unrecognized stock-based compensation expense related to the ESPP was $ 1.5 million, which is expected to be recognized over a remaining weighted-average period of approximately 1.6 years. 128 Table of Contents Janux Therapeutics, Inc.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP San Diego, California February 27, 2025 134 Table of Contents It em 9B. Other Information.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP San Diego, California February 26, 2026 135 Table of Contents Janux Therapeutics, Inc.
San Diego, California February 27, 2025 111 Table of Contents Janux Therapeutics, Inc.
San Diego, California February 26, 2026 111 Table of Contents Janux Therapeutics, Inc.
Due to uncertainties surrounding the realizability of the deferred tax assets, the Company maintains a full valuation allowance against its deferred tax assets at December 31, 2024 and 2023. During the year ended December 31, 2024, the valuation allowance increased by $ 21.8 million.
Due to uncertainties surrounding the realizability of the deferred tax assets, the Company maintains a full valuation allowance against its deferred tax assets at December 31, 2025, 2024, and 2023. During the year ended December 31, 2025, the valuation allowance increased by $ 23.3 million. 131 Table of Contents Janux Therapeutics, Inc.
The grant-date fair value is recognized as compensation expense over the vesting period. As of December 31, 2024, total unrecognized stock-based compensation cost associated wit h RSUs was $ 19.3 million, which is expected to be recognized over a remaining weighted-average period of approximately 3.7 years.
As of December 31, 2025, total unrecognized stock-based compensation cost associated wit h RSUs was $ 25.7 million, which is expected to be recognized over a remaining weighted-average period of approximately 3.0 years.
The Company considers the decline in market value for the securities to be primarily attributable to current economic conditions and interest rate adjustments, rather than credit-related factors and does not intend to sell any securities prior to maturity. No allowance for credit losses has been recorded as of December 31, 2024 or December 31, 2023.
From time to time, the market value of the Company’s debt securities experience declines. This is primarily attributable to economic conditions and interest rate adjustments, rather than credit-related factors. The Company does not intend to sell any securities prior to maturity. No allowance for credit losses has been recorded as of December 31, 2025 or December 31, 2024.
Notes to Financial Statements - (Continued) Year Ended December 31, 2024 2023 2022 Balance at beginning of year $ 2,389 $ 1,273 $ 510 Increases related to prior year tax positions — 126 — Increases related to current year tax positions 1,642 990 763 Balance at end of year $ 4,031 $ 2,389 $ 1,273 The Company had no accrual for interest or penalties on the Company's balance sheets at December 31, 2024 or 2023, and has not recognized interest and/or penalties in the statement of operations and comprehensive loss for the years ended December 31, 2024, 2023 and 2022.
The following table summarizes the changes to the Company’s gross unrecognized tax benefits for the years ended December 31, 2025, 2024 and 2023 (in thousands): Year Ended December 31, 2025 2024 2023 Balance at beginning of year $ 4,031 $ 2,389 $ 1,273 Increases related to prior year tax positions — — 126 Increases related to current year tax positions 1,449 1,642 990 Balance at end of year $ 5,480 $ 4,031 $ 2,389 The Company had no accrual for interest or penalties on the Company's balance sheets at December 31, 2025 or 2024, and has not recognized interest and/or penalties in the statement of operations and comprehensive loss for the years ended December 31, 2025, 2024 and 2023.
The letter of credit amount is subject to a 50 % reduction subject to certain conditions on or following the date that is 54 months following the contractual lease commencement date.
The letter of credit is subject to draw down by the landlord upon certain events of breach or default by the Company. The letter of credit amount is subject to a 50 % reduction subject to certain conditions on or following the date that is 54 months following the contractual lease commencement date.
As of December 31, 2024, there wer e 10,867,540 shares authorized for issuance under the 2021 Plan, inclusive of shares added from 2017 Plan cancellations.
As of December 31, 2025, there wer e 13,571,381 shares authorized for issuance under the 2021 Plan, inclusive of shares added from 2017 Plan cancellations.
We do not believe that inflation had a material effect on our business, financial condition or results of operations during the year ended December 31, 2024. Ite m 8. Financial Statements and Supplementary Data.
Inflation Inflation generally affects us by increasing our cost of labor and preclinical and clinical development costs. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the year ended December 31, 2025. Ite m 8. Financial Statements and Supplementary Data.
As of December 31, 2024 and 2023, the Company had unrecognized tax benefits of $ 4.0 million and $ 2.4 million, respectively, which if recognized currently, should not impact the effective tax rate due to the Company maintaining a full valuation allowance.
As of December 31, 2025 and 2024, the Company had unrecognized tax benefits of $ 5.5 million and $ 4.0 million, respectively, which if recognized currently, should not impact the effective tax rate due to the Company maintaining a full valuation allowance. The Company is subject to taxation in the United States and various state jurisdictions.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 133 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of Janux Therapeutics, Inc.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 134 Table of Contents Janux Therapeutics, Inc.
Treasury securities $ 94,984 $ 490 $ — $ 95,474 U.S. agency bonds 299,831 1,209 ( 195 ) 300,845 Corporate debt securities 161,336 696 ( 35 ) 161,997 Commercial paper 36,254 20 ( 22 ) 36,252 Total $ 592,405 $ 2,415 $ ( 252 ) $ 594,568 As of December 31, 2023 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
Treasury securities $ 94,984 $ 490 $ — $ 95,474 U.S. agency bonds 299,831 1,209 ( 195 ) 300,845 Corporate debt securities 161,336 696 ( 35 ) 161,997 Commercial paper 36,254 20 ( 22 ) 36,252 Total $ 592,405 $ 2,415 $ ( 252 ) $ 594,568 The amortized cost and estimated fair value in the tables above exclude $ 6.4 million and $ 5.4 million of accrued interest receivable as of December 31, 2025 and 2024, respectively.

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