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What changed in Janux Therapeutics, Inc.'s 10-K2022 vs 2023

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Paragraph-level year-over-year comparison of Janux Therapeutics, Inc.'s 2022 and 2023 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 2023 report.

+585 added738 removedSource: 10-K (2024-03-08) vs 10-K (2023-03-10)

Top changes in Janux Therapeutics, Inc.'s 2023 10-K

585 paragraphs added · 738 removed · 438 edited across 2 sections

Item 1. Business

Business — how the company describes what it does

332 edited+102 added280 removed902 unchanged
Biggest changeFor example, the European Union’s General Data Protection Regulation 2016/679 (EU GDPR) and the EU GDPR as it forms part of United Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (the UK GDPR) impose strict requirements for Processing personal information.
Biggest changeSuch 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, as amended by the California Privacy Rights Act of 2020 (CPRA) (collectively, 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).
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.
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.
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.
Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is: a covered benefit under its health plan; safe, effective and medically necessary; appropriate for the specific patient; cost-effective; and neither experimental nor investigational.
Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is: a covered benefit under its health plan; safe, effective and medically necessary; appropriate for the specific patient; cost-effective; and neither experimental nor investigational.
However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
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.
Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, prior to the U.S.
Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, prior to the U.S.
Disputes may arise regarding intellectual property subject to a licensing agreement, including: the scope of rights granted under the license agreement and other interpretation-related issues; the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; the sublicensing of patent and other rights; our diligence obligations under the license agreement and what activities satisfy those diligence obligations; the ownership of inventions and know-how resulting from the creation or use of licensed intellectual property by us alone or with our licensors and partners; the right to control prosecution, maintenance, enforcement, and defense of the licensed patents and improvements thereof; the scope and duration of our payment obligations; and the priority of invention of patented technology.
Disputes may arise regarding intellectual property subject to a licensing agreement, including: the scope of rights granted under the license agreement and other interpretation-related issues; 90 the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; the sublicensing of patent and other rights; our diligence obligations under the license agreement and what activities satisfy those diligence obligations; the ownership of inventions and know-how resulting from the creation or use of licensed intellectual property by us alone or with our licensors and partners; the right to control prosecution, maintenance, enforcement, and defense of the licensed patents and improvements thereof; the scope and duration of our payment obligations; and the priority of invention of patented technology.
There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention, or decide that the other party’s use of our patented technology falls under the safe harbor to patent infringement under 35 U.S.C. §271(e)(1).
There is also a risk that, even if the validity of such patents is upheld, the court will construe the 93 patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention, or decide that the other party’s use of our patented technology falls under the safe harbor to patent infringement under 35 U.S.C. §271(e)(1).
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 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; 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; 93 Table of Contents 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 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; 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; 89 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.
Federal Food, Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices; 84 Table of Contents 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; 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; 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.
By engineering our TRACTrs and TRACIrs with novel peptide masks that are designed (i) to be selectively activated in the tumor microenvironment and (ii) for any activated TCEs or non-TCE based immunomodulators to be rapidly cleared from healthy tissue upon escaping from the tumor, our product candidates have the potential to overcome the toxicity challenges of TCEs, non-TCE based immunomodulators and systemic immunotherapies in general. Potential for extended half-life of our TRACTrs and TRACIrs.
By engineering our TRACTrs and TRACIrs with novel peptide masks that are designed (i) to be selectively activated in the tumor microenvironment and (ii) for any activated TCEs or non-TCE based immunomodulators to be rapidly cleared from healthy tissue upon escaping from the tumor, our product candidates have the potential to 4 overcome the toxicity challenges of TCEs, non-TCE based immunomodulators and systemic immunotherapies in general. Potential for extended half-life of our TRACTrs and TRACIrs.
Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan designation to a biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States but for which there is no reasonable expectation that the cost of developing and making the product for this type of disease or condition will be recovered from sales of the product in the United States.
Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan designation to a biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the 38 United States, or more than 200,000 individuals in the United States but for which there is no reasonable expectation that the cost of developing and making the product for this type of disease or condition will be recovered from sales of the product in the United States.
We may continue to be a smaller reporting company even after we are no longer an emerging growth company, which would allow us to take advantage of many of the same exemptions available to emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation.
We may continue to be a smaller reporting company even after we are no longer an emerging growth company, which would allow us to take advantage of many of the same exemptions available to emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure 109 obligations regarding executive compensation.
After the protein A affinity chromatography step, TRACTrs and TRACIrs are further purified and polished using standard ion exchange, hydrophobic-interaction and/or multi-modal chromatography, virus filtration, and ultrafiltration/diafiltration formulation steps. Our anticipated dosing strategy gives us the advantage of manufacturing at relatively modest scale and formulating our drug products at low protein concentrations in typical formulation matrices.
After the protein A affinity chromatography step, TRACTrs and TRACIrs are further purified and polished using standard ion exchange, hydrophobic-interaction and/or multi-modal chromatography, virus filtration, and ultrafiltration/diafiltration formulation steps. Our dosing strategy gives us the advantage of manufacturing at relatively modest scale and formulating our drug products at low protein concentrations in typical formulation matrices.
They are primarily confined to treatment for hematological malignancies, and CAR T cell therapies have not to date been successfully developed for any solid tumor. While we believe that TCEs hold promise in treating solid tumors, three properties of TCEs derived from other platforms have limited their potential: Cytokine release syndrome (CRS).
They are primarily confined to treatment for hematological malignancies, and CAR T cell therapies have not to date been successfully developed for any solid tumor. 8 While we believe that TCEs hold promise in treating solid tumors, three properties of TCEs derived from other platforms have limited their potential: Cytokine release syndrome (CRS).
Treatment options for RCC In RCC, greater than 90 percent of patients express EGFR. Treatment of 1L mRCC typically involves the combination of a PD1 or PDL1 checkpoint inhibitor (pembrolizumab, nivolumab, avelumab) with an anti-VEGFR TKI such as axitinib, cabozantinib or lenvatinib. Alternatively, nivolumab may be combined with the CTLA-4 checkpoint inhibitor ipilimumab.
Treatment options for RCC 26 In RCC, greater than 90 percent of patients express EGFR. Treatment of 1L mRCC typically involves the combination of a PD1 or PDL1 checkpoint inhibitor (pembrolizumab, nivolumab, avelumab) with an anti-VEGFR TKI such as axitinib, cabozantinib or lenvatinib. Alternatively, nivolumab may be combined with the CTLA-4 checkpoint inhibitor ipilimumab.
We granted Merck an exclusive, worldwide, royalty-bearing, sublicensable license to certain of our patent rights and know-how with respect to the Collaboration Targets, in each case once designated by Merck, to research, develop, make, have made, use, import, offer to sell, and sell compounds and any licensed products related thereto.
We granted Merck an exclusive, worldwide, royalty-bearing, sublicensable license to certain of our patent rights and know-how with respect to the Collaboration Targets, in each case once designated by Merck, to research, develop, make, have made, use, import, offer to sell, and sell compounds and any licensed 32 products related thereto.
We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Pharmaceutical Coverage, Pricing and Reimbursement The availability and extent of coverage and adequate reimbursement by governmental and private third-party payors are essential for most patients to be able to afford expensive medical treatments.
We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Pharmaceutical Coverage, Pricing and Reimbursement 50 The availability and extent of coverage and adequate reimbursement by governmental and private third-party payors are essential for most patients to be able to afford expensive medical treatments.
Treatment options for mCRC Treatment of CRC typically involves cytotoxic chemotherapy in a regimen containing folinic acid, fluorouracil, and irinotecan, called FOLFIRI, and radiation. Anti-EGFR mAbs such as cetuximab (ERBITUX, marketed by Eli Lilly) and panitumumab (VECTIBIX, marketed by Amgen and Takeda) can be added to standard therapy.
Treatment options for mCRC Treatment of CRC typically involves cytotoxic chemotherapy in a regimen containing folinic acid, fluorouracil, and irinotecan, called FOLFIRI, and radiation. Anti-EGFR mAbs such as cetuximab (ERBITUX, marketed by Eli Lilly) and panitumumab (VECTIBIX, marketed by Amgen and Takeda) can be added to standard 25 therapy.
The CHMP is required to issue an opinion within 210 days of receipt of a valid application, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. The process is complex and involves extensive consultation with the regulatory authorities of member states and a number of experts.
The CHMP is required to issue an opinion within 210 days of receipt of a valid application, though the clock is stopped if it is necessary to ask the applicant for 42 clarification or further supporting data. The process is complex and involves extensive consultation with the regulatory authorities of member states and a number of experts.
Further, new therapies may change the estimated incidence or prevalence of the cancers that we are targeting. Consequently, even if our product candidates are approved for a second or third line of therapy, the number of patients who may be eligible for treatment with our product candidates may turn out to be much lower than expected.
Further, new therapies may change the estimated incidence or prevalence of the cancers that we are targeting. Consequently, even if our product candidates are approved for a second or third line of therapy, the number of patients who may be eligible for treatment with our product candidates may turn out to be much lower than 71 expected.
Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.
Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products. As a result, our patent portfolio may 97 not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.
During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.
During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own 70 preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.
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.
If our defenses to these claims fail, in addition to 94 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.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the 44 product. The regulatory authorities may also impose specific obligations as a condition of the MA.
An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and 87 products.
The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as 108 limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
We plan to selectively consider other strategic collaboration opportunities in the future. Our Strategy Our goal is to unleash the potential of our TRACTr and TRACIr platforms technology to transform the lives of cancer patients. To achieve this goal, critical elements of our strategy include the following: Advance our lead TRACTr programs through clinical development.
We plan to selectively consider other strategic collaboration opportunities in the future. Our Strategy Our goal is to unleash the potential of our TRACTr and TRACIr platforms technology to transform the lives of cancer patients. To achieve this goal, critical elements of our strategy include the following: 7 Advance our lead TRACTr programs through clinical development.
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 will allow our products to be manufactured at a substantially lower cost than monoclonal antibodies.
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 than monoclonal antibodies.
While any reduction or halt in the supply of BDS from this contract manufacturer could limit our ability to develop our product candidates until a replacement contract manufacturer is found and qualified, we believe that we will have sufficient BDS to support future clinical trial programs.
While any reduction or halt in the supply of BDS from this contract manufacturer could limit our ability to develop our product candidates until a replacement contract manufacturer is found and qualified, we believe that we will have sufficient BDS to support current and future clinical trial programs.
We have not undertaken a Section 382 study, and it is possible that we have previously undergone one or more ownership changes so that our use of net operating losses is subject to limitation. We may experience ownership changes in the future as a result of subsequent shifts in our stock ownership.
We have not undertaken a Section 382 study, and it is possible that we have previously undergone one or more ownership changes so that our use of net operating losses is subject to limitation. We may experience ownership changes in the future as a result of subsequent shifts in our stock 78 ownership.
If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology.
If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and 91 our competitors could market competing products and technology.
The pharmaceutical and biotechnology industries have produced a considerable number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
The pharmaceutical and biotechnology industries have produced a considerable number of patents, and it may not always be clear to industry 92 participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
We are primarily concerned with the following attributes of a potential product candidate: o Manufacturability using standard mammalian cell expression systems; o Drug-like properties such as solubility, thermal stability, and stability in human serum; and o Optimal performance with efficient linker cleavage, mask removal, antigen-binding, albumin-binding, and functional activity. 15 Table of Contents Our extensive library of masks and linkers combined with our protein engineering expertise allows us to generate product candidates that meet the high standards that we have set for therapeutic candidates that we believe have the potential to have clinical activity across a broad spectrum of indications.
We are primarily concerned with the following attributes of a potential product candidate: o Manufacturability using standard mammalian cell expression systems; o Drug-like properties such as solubility, thermal stability, and stability in human serum; and o Optimal performance with efficient linker cleavage, mask removal, antigen-binding, albumin-binding, and functional activity. 15 Our extensive library of masks and linkers combined with our protein engineering expertise allows us to generate product candidates that meet the high standards that we have set for therapeutic candidates that we believe have the potential to have clinical activity across a broad spectrum of indications.
Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates We are early in our development efforts and all of our product candidates and research programs other than JANX007 and JANX008 are in the preclinical development or discovery stage. We have a very limited of conducting clinical trials to test our product candidates in humans.
Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates We are early in our development efforts and all of our product candidates and research programs other than JANX007 and JANX008 are in the preclinical development or discovery stage. We have a very limited history of conducting clinical trials to test our product candidates in humans.
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; 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; trading activity by a limited number of stockholders who together beneficially own a majority of our outstanding common stock; the published opinions and third-party valuations by banking and market analysts; political uncertainty and/or instability in the United States; the ongoing and future impact of the COVID-19 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 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; 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; trading activity by a limited number of stockholders who together beneficially own a majority of our outstanding common stock; 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 resurgence of COVID-19 or other health epidemic or pandemic; and any other factors discussed in this Annual Report.
However, the actual protection afforded by a patent varies on a product-by-product basis, from country-to-country, and depends upon many factors, including the type of patent, the scope of its claims, the availability of regulatory-related extensions, the availability of legal remedies in a particular country, and the validity and enforceability of the patent.
However, the actual protection afforded by a patent varies on a 34 product-by-product basis, from country-to-country, and depends upon many factors, including the type of patent, the scope of its claims, the availability of regulatory-related extensions, the availability of legal remedies in a particular country, and the validity and enforceability of the patent.
European Union member states may approve a specific price for a product, may adopt a system of direct or indirect controls on the profitability of the company placing the product on the market or monitor and control prescription volumes and issue guidance to physicians to limit prescriptions.
European Union member states may 51 approve a specific price for a product, may adopt a system of direct or indirect controls on the profitability of the company placing the product on the market or monitor and control prescription volumes and issue guidance to physicians to limit prescriptions.
Comparable foreign regulatory authorities may require compliance with similar requirements. The facilities and quality systems of our third-party contract manufacturers must pass a pre-approval inspection for compliance with the applicable regulations as a condition of marketing approval of our product candidates.
Comparable foreign regulatory authorities may require compliance with similar requirements. The facilities and quality systems of our third-party contract 66 manufacturers must pass a pre-approval inspection for compliance with the applicable regulations as a condition of marketing approval of our product candidates.
The value to employees of stock options that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies.
The value to employees of stock options that vest over time may be 76 significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies.
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; 41 Table of Contents 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: 35 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.
Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.
Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in 36 the clinical trials are minimized and are reasonable in relation to anticipated benefits.
FDA Review Process Following completion of the clinical trials, the results of preclinical studies and clinical trials are submitted to the FDA as part of a BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data.
FDA Review Process 37 Following completion of the clinical trials, the results of preclinical studies and clinical trials are submitted to the FDA as part of a BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data.
The clinical trial requirements of the FDA, EMA and other comparable foreign regulatory agencies and authorities, and the criteria regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products.
The clinical trial requirements of the FDA, EMA and other comparable foreign regulatory authorities, and the criteria regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products.
Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. Adverse event reporting and submission of periodic safety summary reports is required following FDA approval of a BLA.
Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. 40 Adverse event reporting and submission of periodic safety summary reports is required following FDA approval of a BLA.
Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace.
Supreme Court 81 ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace.
The FDA, 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, the European Commission 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 and the European Commission 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, the European Commission'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 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. 66 Table of Contents Of the large number of drugs in development, only a small percentage successfully complete the FDA, the European Commission, or other regulatory approval processes and are commercialized.
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, the European Commission 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 and the European Commission 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, the European Commission'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 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. 62 Of the large number of drugs in development, only a small percentage successfully complete the FDA, the European Commission, or other regulatory approval processes and are commercialized.
In addition, pursuant to our 2021 Employee Stock Purchase Plan, the number of shares of our common stock reserved for issuance automatically increases on January 1 of each calendar year, starting on January 1, 2022 through January 1, 2031, by the lesser of (i) 1% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, and (ii) 932,000 shares; provided that before the date of any such increase, our board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
In addition, pursuant to our 2021 Employee Stock Purchase Plan, the number of shares of our common stock reserved for issuance automatically increases on January 1 of each calendar year, through January 1, 2031, by the lesser of (i) 1% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, and (ii) 932,000 shares; provided that before the date of any such increase, our board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. 51 Table of Contents Federal civil and criminal false claims laws, such as the False Claims Act (FCA), which can be enforced by private citizens on behalf of the government through civil whistleblower or qui tam actions, and the federal civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Federal civil and criminal false claims laws, such as the False Claims Act (FCA), which can be enforced by private citizens on behalf of the government through civil whistleblower or qui tam actions, and the federal civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
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 by 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; 60 Table of Contents 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; 56 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.
Any of these occurrences may harm our business, financial condition and prospects significantly. 64 Table of Contents In addition, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: regulatory authorities may suspend, vary, withdraw, or limit approvals of such product, or seek an injunction against its manufacture or distribution; regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; we may be required to change the way a product is administered or conduct additional clinical trials; the product may become less competitive, and our reputation may suffer; we may be obliged to, need to, or decide to recall or remove the product from the marketplace; and we may be subject to fines, injunctions or the imposition of civil or criminal penalties.
Any of these occurrences may harm our business, financial condition and prospects significantly. 60 In addition, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: regulatory authorities may suspend, vary, withdraw, or limit approvals of such product, or seek an injunction against its manufacture or distribution; regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; we may be required to change the way a product is administered or conduct additional clinical trials; the product may become less competitive, and our reputation may suffer; we may be obliged to, need to, or decide to recall or remove the product from the marketplace; and we may be subject to fines, injunctions or the imposition of civil or criminal penalties.
Even if we eventually complete clinical testing and receive approval of a BLA or foreign marketing authorization application for our product candidates, the FDA, the European Commission, or the applicable foreign regulatory agency may grant approval contingent on the performance of costly additional clinical trials, including Phase 4 clinical trials, and/or in the case of the FDA, the implementation of a REMS, and in the case of comparable foreign regulatory authorities equivalent actions, which may be required to ensure safe use of the drug after approval.
Even if we eventually complete clinical testing and receive approval of a BLA or foreign marketing authorization application for our product candidates, the FDA, the European Commission, or the applicable foreign regulatory authority may grant approval contingent on the performance of costly additional clinical trials, including Phase 4 clinical trials, and/or in the case of the FDA, the implementation of a REMS, and in the case of comparable foreign regulatory authorities equivalent actions, which may be required to ensure safe use of the drug after approval.
As a result, our collaborators may elect to de-prioritize our programs, change their strategic focus or pursue alternative technologies in a manner that results in reduced, delayed or no revenue to us.
As a result, our collaborators may elect to de-prioritize our programs, change their strategic focus or pursue alternative 73 technologies in a manner that results in reduced, delayed or no revenue to us.
We cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
We cannot be certain that our 96 trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
These generally include immune cell redirecting therapeutics (e.g., T cell engagers, T cell immunomodulators), adoptive cellular therapies (e.g., CAR T cell therapies), antibody-drug conjugates, targeted radiopharmaceuticals, targeted immunotoxin, and targeted cancer vaccines.
These generally include immune cell 31 redirecting therapeutics (e.g., T cell engagers, T cell immunomodulators), adoptive cellular therapies (e.g., CAR T cell therapies), antibody-drug conjugates, targeted radiopharmaceuticals, targeted immunotoxin, and targeted cancer vaccines.
There is a risk that our product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs.
There is a risk that our product candidates may induce adverse events. If we cannot successfully 75 defend against product liability claims, we could incur substantial liability and costs.
The number of shares of our common stock reserved for issuance under our 2021 Plan automatically increases on January 1 of each calendar year, starting on January 1, 2022 through January 1, 2031, in an amount equal to the lesser of (i) 5% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase; or (ii) a lesser number of shares determined by our board of directors prior to the applicable January 1st.
The number of shares of our common stock reserved for issuance under our 2021 Plan automatically increases on January 1 of each calendar year, through January 1, 2031, in an amount equal to the lesser of (i) 5% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase; or (ii) a lesser number of shares determined by our board of directors prior to the applicable January 1st.
Although physicians may prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued.
Although physicians may prescribe products for off-label uses as the FDA and other regulatory authorities do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued.
The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand.
The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between 46 pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand.
Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for the following types of actions or 105 Table of Contents proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers, or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers, or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; (iv) any action or proceeding to interpret, apply, enforce, or determine the validity of our amended and restated certificate of incorporation or our amended and restated bylaws; (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and (vi) any action asserting a claim against us or any of our directors, officers, or other employees governed by the internal affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as defendants.
Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or 101 former directors, officers, or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers, or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; (iv) any action or proceeding to interpret, apply, enforce, or determine the validity of our amended and restated certificate of incorporation or our amended and restated bylaws; (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and (vi) any action asserting a claim against us or any of our directors, officers, or other employees governed by the internal affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as defendants.
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. 17 Table of Contents Figure 9.
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. 17 Figure 9.
On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. In addition, in 2012, the U.S.
On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024. In addition, in 2012, the U.S.
The use of biologically derived ingredients can also lead to allegations of harm, including infections or allergic reactions, or closure of product facilities due to possible contamination.
The use of biologically 67 derived ingredients can also lead to allegations of harm, including infections or allergic reactions, or closure of product facilities due to possible contamination.
If we (or a third-party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal information); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms.
If we (or a third-party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal information); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention; interruptions in our operations (including availability of data); financial loss; and other similar harms.
We believe these data suggest our PSMA-TRACTr will have the potential to reduce CRS risk relative to an unmasked PSMA-TCE. Furthermore, in a separate study of our PSMA-TRACTr dosed at 1,000µg/kg once-weekly for three weeks in NHPs, no dose-limiting toxicities were identified. Figure 13.
We believe these data suggest our PSMA-TRACTr will have the potential to reduce CRS risk relative to an unmasked PSMA-TCE. Furthermore, in a separate study of our PSMA-TRACTr dosed at 1,000µg/kg once-weekly for three weeks in NHPs, no dose-limiting toxicities were identified. Figure 12.
While no on-target healthy tissue toxicity was reported, treatment-emergent increases in alanine‌ aminotransferase and aspartate aminotransferase did occur, and over half of patients in this trial developed Grade 3 19 Table of Contents or Grade 4 drug-related SAEs. Three patients dosed with continuous infusion developed CRS; two were Grade 2 and one was Grade 3.
While no on-target healthy tissue toxicity was reported, treatment-emergent increases in alanine‌ 19 aminotransferase and aspartate aminotransferase did occur, and over half of patients in this trial developed Grade 3 or Grade 4 drug-related SAEs. Three patients dosed with continuous infusion developed CRS; two were Grade 2 and one was Grade 3.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year until 2031.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year until 2032.
Each master cell bank is or will be stored in two independent locations, and we intend to produce working cell banks for each product candidate later in the course of product development. It is possible that we could lose multiple cell banks from multiple locations and have our manufacturing severely impacted by the need to replace the cell banks.
Each master cell bank is or will be stored in two independent locations, and we intend to produce working cell banks for each product candidate later in the course of product development. It is possible that we could lose our cell banks from our storage locations and have our manufacturing severely impacted by the need to replace the cell banks.
Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.
Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.
In the 1L setting with checkpoint inhibitor combinations, the objective response rates range from approximately 30-70% with median PFS (mPFS) from 12-24 months and mOS typically being greater than 40 months. Almost all 1L patients become resistant to standard therapy with less than 50% being eligible to receive 2L therapy.
In the 1L setting with checkpoint inhibitor combinations, the objective response rates range from approximately 40-70% with median PFS (mPFS) from 12-24 months and mOS typically being greater than 37 months. Almost all 1L patients become resistant to standard therapy with less than 50% being eligible to receive 2L therapy.
We expect to incur increasing levels of operating losses over the next several years and for the foreseeable future as we advance our product candidates through clinical development. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ deficit and working capital.
We expect to incur increasing levels of operating losses over the next several years and for the foreseeable future as we advance our product candidates through clinical development. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
The FDA, the EMA or other comparable foreign regulatory authorities, may also require us to conduct additional studies or trials for our product candidates either prior to or post-approval, or may object to elements of our clinical development program such as the number of subjects in our clinical trials from the United States or abroad.
The FDA, the EMA, the European Commission or other comparable foreign regulatory authorities, may also require us to conduct additional studies or trials for our product candidates either prior to or post-approval, or may object to elements of our clinical development program such as the number of subjects in our clinical trials from the United States or abroad.
Our pipeline is summarized below: Our PSMA-TRACTr (JANX007) for the treatment of mCRPC We are developing our PSMA-TRACTr product candidate for the treatment of mCRPC. In a preclinical study, PSMA-TRACTr showed a 500-fold reduced ability to induce T cell-mediated killing of prostate cancer cells when masked compared to when unmasked.
Our wholly-owned pipeline is summarized below: Our PSMA-TRACTr (JANX007) for the treatment of mCRPC We are developing our PSMA-TRACTr product candidate for the treatment of mCRPC. In a preclinical study, PSMA-TRACTr showed a 500-fold reduced ability to induce T cell-mediated killing of prostate cancer cells when masked compared to when unmasked.
Regulatory Approval in the European Union The EMA is an agency of the European Union. It coordinates the evaluation and monitoring of centrally authorized medicinal products.
Regulatory Approval in the European Union 41 The EMA is an agency of the European Union. It coordinates the evaluation and monitoring of centrally authorized medicinal products.
Outside the United States, an increasing number of laws, regulations, and industry standards may govern to data privacy and security. For example, the European Union’s General Data Protection Regulation (EU GDPR) and the United Kingdom’s GDPR (UK GDPR), impose strict requirements for processing personal data and violators of these laws face significant penalties.
Outside the United States, an increasing number of laws, regulations, and industry standards may govern to data privacy and security. For example, the European Union’s General Data Protection Regulation (EU GDPR), the United Kingdom’s GDPR (UK GDPR) and Australia’s Privacy Act impose strict requirements for processing personal data and violators of these laws face significant penalties.
Although we try to ensure that our employees and consultants do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may become subject to claims that we 98 Table of Contents caused an employee to breach the terms of his or her non-competition or non-solicitation agreement, or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor.
Although we try to ensure that our employees and consultants do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may become subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement, or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor.
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; 67 Table of Contents suspension or imposition of restrictions on operations, including product manufacturing; 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; 63 suspension or imposition of restrictions on operations, including product manufacturing; 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.

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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 changeStatements of Conv ertible Preferred Stock and Stockholders’ Equity (Deficit) (in thousands, except share data) Convertible Preferred Stock Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’ Equity Shares Amount Shares Amount Capital Loss Deficit (Deficit) Balance at December 31, 2020 6,838,829 21,624 1,046,599 1 100 ( 14,739 ) ( 14,638 ) Issuance of Series A convertible preferred stock, net of $ 278 of issuance costs 5,894,740 55,722 Issuance of Series B convertible preferred stock, net of $ 175 of issuance costs 8,038,073 124,825 Conversion of convertible preferred stock to common stock in connection with initial public offering ( 20,771,642 ) ( 202,171 ) 26,608,460 27 202,144 202,171 Initial public offering, net of $ 18,703 of issuance costs 13,110,000 13 204,154 204,167 Exercise of common stock options 113,418 20 20 Shares issued under employee stock purchase plan 11,452 164 164 Vesting of restricted shares 353,208 475 475 Stock-based compensation 6,910 6,910 Unrealized loss on available-for-sale securities, net ( 270 ) ( 270 ) Net loss ( 32,672 ) ( 32,672 ) 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 See accompanying notes. 130 Table of Contents Janux Therapeutics, Inc.
Biggest changeStatements 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 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 See accompanying notes. 128 Janux Therapeutics, Inc.
Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods.
Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods.
Short-term investments are carried at fair value with the unrealized gains and losses included in accumulated other comprehensive income (loss) as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument.
Short-term investments are carried at fair value with the unrealized gains and losses included in accumulated other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument.
COI 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 owns greater than 5 % of our outstanding capital stock.
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 owns greater than 5 % of our outstanding capital stock.
Federal NOL carryforwards totaling $ 0.5 million begin to expire in 2037 , unless previously utilized, and federal NOL carryforwards of $ 49.5 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 $ 49.4 million generated after 2017, may be carried forward indefinitely but can only be utilized to offset 80 % of future taxable income.
The Company has irrevocably elected not to avail itself of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. 2.
The Company has irrevocably elected not to avail itself of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm on internal control over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies.” 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, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm on internal control over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies.” 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, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s assessment included the preparation of cash flow forecasts resulting in management’s conclusion that the Company has sufficient capital to fund operations for at least 12 months from the date the financial statements for the year ended December 31, 2022 are issued. Use of Estimates The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles ("GAAP").
Management’s assessment included the preparation of cash flow forecasts resulting in management’s conclusion that the Company has sufficient capital to fund operations for at least 12 months from the date the financial statements for the year ended December 31, 2023 are issued. Use of Estimates The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles ("GAAP").
When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
When evaluating the adequacy of the accrued expenses, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
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, 2022, 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, 2023, 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, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, 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, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
Cash and cash equivalents include cash in readily available checking accounts, commercial paper 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 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).
The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of December 31, 2022, the Company is not currently party to any material legal proceedings. 4.
The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of December 31, 2023, the Company is not currently party to any material legal proceedings. 4.
The 2021 Support Services Agreement was most recently renewed in January 2023 and will continue to renew for additional one-year renewal periods until terminated by the parties. Either party may terminate the 2021 Support Services Agreement with 30 days written notice.
The 2021 Support Services Agreement was most recently renewed in January 2024 and will continue to renew for additional one-year renewal periods until terminated by the parties. Either party may terminate the 2021 Support Services Agreement with 30 days written notice.
The 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 balance.
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 and our Acting Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2022.
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 and our Acting Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2023.
The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to the short-term nature of those instruments.
The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, prepaid and other current assets, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2022, our Chief Executive Officer and our Acting Chief 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, 2023, our Chief Executive Officer and our Acting Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
In accordance with ASC 606, the Company determined that the transaction price under the Merck Agreement for each the First Collaboration Target and the Second Collaboration Target is $ 11.4 million, consisting of the upfront, non-refundable and non-creditable payment of $ 8.0 million and the aggregate estimated reimbursable research program funding for each the First Collaboration Target and the Second Collaboration Target of $ 3.4 million.
In accordance with ASC 606, the Company determined that the initial transaction price under the Merck Agreement for the First Collaboration Target is $ 11.4 million, consisting of the upfront, non-refundable and non-creditable payment of $ 8.0 million and the aggregate estimated reimbursable research program funding of $ 3.4 million.
Therefore, this aggregate consideration has been fully constrained and is therefore not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price.
Therefore, this aggregate consideration has been fully constrained and is not included in the transaction price at December 31, 2023. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price.
In June 2021, employees began to enroll in the ESPP and the Company’s first offering period commenced. Stock-based compensation expense related to the ESPP was $ 0.6 million and $ 0.2 million for the years ended December 31, 2022 and 2021, respectively.
In June 2021, employees began to enroll in the ESPP and the Company’s first offering period commenced. Stock-based compensation expense related to the ESPP was $ 0.9 million and $ 0.6 million for the years ended December 31, 2023 and 2022, respectively.
Operating Leases In October 2021, the Company entered into a lease agreement (the "Torrey Plaza Lease") to lease office and laboratory space in San Diego, California. The Company determined this facilities lease was an operating lease at the inception of the lease contract.
Operating Leases In October 2021, the Company entered into a lease agreement (the “Torrey Plaza Lease”) to lease office and laboratory space in San Diego, California. The Company determined this facilities lease was an operating lease at the inception of the lease contract.
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, 2022 Due in 1 Year or Less Due Between 1 and 2 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, 2023 Due in 1 Year or Less Due Between 1 and 3 Years U.S.
Notes to Financial Statements - (Continued) Under the Merck Agreement, the Company is eligible to receive up to an aggregate of $ 142.5 million per Collaboration Target in milestone payments ($ 285.0 million collectively for both Collaboration Targets), contingent on the achievement of certain regulatory and development milestones.
Under the Merck Agreement, the Company is eligible to receive up to an aggregate of $ 142.5 million per Collaboration Target in milestone payments ($ 285.0 million collectively for both Collaboration Targets), contingent on the achievement of certain regulatory and development milestones.
To date the Company has funded its operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the issuance of common stock in its initial public offering (“IPO”), the exercise of common stock options and amounts received under a collaboration agreement.
To date the Company has funded its operations primarily with the net proceeds from the issuance of convertible promissory notes, the issuance of convertible preferred stock, the issuance of common stock in its initial public offering (“IPO”), the issuance of common stock and pre-funded common stock warrants in an underwritten offering, the exercise of common stock options, and amounts received under a collaboration agreement.
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, 2022: Assets: Cash equivalents: Money market funds $ 12,697 $ 12,697 $ $ Total cash equivalents 12,697 12,697 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, 2023: Assets: Cash equivalents: Money market funds $ 14,751 $ 14,751 $ $ Total cash equivalents 14,751 14,751 Short-term investments: U.S.
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”) and Tumor Activated Immunomodulator (“TRACIr”) platforms to better treat patients suffering from cancer.
Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
Notes to Financial Statements - (Continued) an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
Liquidity and Capital Resources From its inception through December 31, 2022, 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 clinical and preclinical assets.
Liquidity and Capital Resources From its inception through December 31, 2023, 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.
Stock-Based Compensation Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options and employee stock purchase rights, recognized on a straight-line basis over the requisite service period for stock options and over the respective offering period for employee stock purchase plan rights.
Notes to Financial Statements - (Continued) Stock-based compensation expense represents the grant date fair value of equity awards, consisting of stock options and employee stock purchase rights, recognized on a straight-line basis over the requisite service period for stock options and over the respective offering period for employee stock purchase plan rights.
The Company has incurred net losses and negative cash flows from operations since inception and had an accumulated deficit of $ 110.5 million as of December 31, 2022. 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 $ 168.8 million as of December 31, 2023. The Company has a limited operating history, has not generated any product revenue, and the sales and income potential of its business is unproven.
Consideration in the Merck Agreement consists of (i) an $ 8.0 million non-refundable and non-creditable upfront fee, (ii) $ 8.0 million paid upon the selection of the Second Collaboration Target, (iii) research program funding (iv) development and regulatory milestones, (v) commercial milestones, and (vi) royalty payments. 144 Table of Contents Janux Therapeutics, Inc.
Consideration in the Merck Agreement consists of (i) an $ 8.0 million non-refundable and non-creditable upfront fee, (ii) $ 8.0 million paid upon the selection of the Second Collaboration Target, (iii) research program funding (iv) development and regulatory milestones, (v) commercial milestones, and (vi) royalty payments.
The Company does not have material short-term lease costs. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable. 136 Table of Contents Janux Therapeutics, Inc.
The Company does not have material short-term lease costs. Lease liabilities are measured at the present value of the lease payments not yet paid discounted using the discount rate for the lease established at the lease commencement date. To determine the present value, the implicit rate is used when readily determinable.
Notes to Financial Statements - (Continued) For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate (“IBR”) based on the information available at the lease commencement date in determining the present value of lease payments.
For those leases where the implicit rate is not provided, the Company determines an incremental borrowing rate (“IBR”) based on the information available at the lease commencement date in determining the present value of lease payments.
As of December 31, 2022 and 2021, the Company had unrecognized tax benefits of $ 1.3 million an d $ 0.5 mil lion, 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, 2023 and 2022, the Company had unrecognized tax benefits of $ 2.4 million an d $ 1.3 mil lion, respectively, which if recognized currently, should not impact the effective tax rate due to the Company maintaining a full valuation allowance.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not applicable to a smaller reporting company. 125 Table of Contents Ite m 8. Financial Statements and Supplementary Data.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not applicable to a smaller reporting company. Ite m 8. Financial Statements and Supplementary Data.
As it relates to Merck's option to select a Second Collaboration Target, which was exercised during the year ended December 31, 2022, the Company concluded that this option represented a customer option to purchase additional goods or services that is not a material right and, therefore, is accounted for as a separate contract and separate performance obligation to purchase the additional goods or services.
As it relates to Merck's option to select a Second Collaboration Target, which was exercised in May 2022, the Company concluded that this option represented a customer option to purchase additional goods or services that is not a material right and, therefore, is accounted for as a separate contract and separate performance obligation to purchase the additional goods or services.
The Company records an allowance for credit losses when unrealized losses are due to credit-related factors. Realized gains and losses are calculated using the specific identification method and recorded as interest income. 134 Table of Contents Janux Therapeutics, Inc.
The Company records an allowance for 132 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) credit losses when unrealized losses are due to credit-related factors. Realized gains and losses are calculated using the specific identification method and recorded as interest income.
Notes to Financial Statements - (Continued) automatically increases on January 1 of each calendar year through January 1, 2031, in an amount equal to the lesser of (i) 1 % of the total number of shares of the Company’s common stock on the last day of the calendar month before the date of each automatic increase and (ii) 932,000 shares; provided that before the date of any such increase, the Company’s board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
In addition, the number of shares of common stock available for issuance under the ESPP automatically increases on January 1 of each calendar year through January 1, 2031, in an amount equal to the lesser of (i) 1 % of the total number of shares of the Company’s common stock on the last day of the calendar month before the date of each automatic increase and (ii) 932,000 shares; provided that before the date of any such increase, the Company’s board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
The following table summarizes the changes to the Company’s gross unrecognized tax benefits for the years ended December 31, 2022 and 2021 (in thousands): Year Ended December 31, 2022 2021 Balance at beginning of year $ 510 $ 234 Decreases related to prior year tax positions ( 50 ) Increases related to current year tax positions 763 326 Balance at end of year $ 1,273 $ 510 The Company had no accrual for interest or penalties on the Company's balance sheets at December 31, 2022 or 2021, and has not recognized interest and/or penalties in the statement of operations and comprehensive loss for the years ended December 31, 2022 and 2021.
The following table summarizes the changes to the Company’s gross unrecognized tax benefits for the years ended December 31, 2023 and 2022 (in thousands): Year Ended December 31, 2023 2022 Balance at beginning of year $ 1,273 $ 510 Increases related to prior year tax positions 126 Increases related to current year tax positions 990 763 Balance at end of year $ 2,389 $ 1,273 The Company had no accrual for interest or penalties on the Company's balance sheets at December 31, 2023 or 2022, and has not recognized interest and/or penalties in the statement of operations and comprehensive loss for the years ended December 31, 2023 and 2022.
(the Company) as of December 31, 2022 and 2021, the related statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
(the Company) as of December 31, 2023 and 2022, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”).
The assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants under its Plans were as follows: Year Ended December 31, 2022 2021 Risk-free interest rate 1.5 % 4.2 % 0.8 % 1.6 % Expected volatility 81 % 85 % 83 % 87 % Expected term (in years) 5.3 6.1 5.5 10.0 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, 2023 2022 Risk-free interest rate 3.5 % 4.7 % 1.5 % 4.2 % Expected volatility 82 % 87 % 81 % 85 % Expected term (in years) 5.3 6.1 5.3 6.1 Expected dividend yield Risk-free interest rate .
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 stock of a company by certain stockholders or public groups.
Notes to Financial Statements - (Continued) of 1986, as amended (the "Code"). 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 stock of a company by certain stockholders or public groups.
Operating lease expense for year ended December 31, 2021 was immaterial. Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2021 was $ 0.3 million. Contingencies From time to time, the Company may be subject to claims or lawsuits arising in the ordinary course of business.
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022 was $ 0.2 million. Contingencies From time to time, the Company may be subject to claims or lawsuits arising in the ordinary course of business.
Given the Company’s limited historical stock price volatility data, the expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry.
Given the Company’s limited historical stock price volatility data, the expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available, including the Company's historical volatility, weighted by years of available trading data within the expected term. The peer group was developed based on companies in the biotechnology industry.
As of December 31, 2022 , total unrecognized stock-based compensation cost associated with option grants was $ 40.8 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.5 years.
As of December 31, 2023 , total unrecognized stock-based compensation cost associated with option grants was $ 34.1 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.2 years.
Operating lease expense for year ended December 31, 2022 was $ 2.8 million. Lease incentives received for amounts included in the measurement of lease liabilities for the year ended December 31, 2022 was $ 0.7 million. Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2022 was $ 0.2 million.
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2023 was $ 2.8 million. Operating lease expense included in the measurement of lease liabilities for year ended December 31, 2022 was $ 2.8 million.
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. The Company has no t recognized any impairment losses through December 31, 2022 .
Notes to Financial Statements - (Continued) 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. The Company has not recognized any impairment losses through December 31, 2023 .
Related Party Transactions In January 2021, the Company entered into a Support Services Agreement (the "2021 Support Services Agreement") with COI Pharmaceuticals, Inc. (“COI”) that outlines the terms of services provided by COI to the Company, as well as the fees charged for such services.
Related Party Transactions In January 2021, the Company 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 the Company, as well as the fees charged for such services.
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. No allowance for credit losses has been recorded as of December 31, 2022 or December 31, 2021.
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, 2023 or December 31, 2022.
With respect to the remaining variable consideration within the Merck Agreement, including milestone and royalty payments, the Company determined that as of December 31, 2022 these payments were probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control.
The Company concluded that there was not a significant financing component under the Merck Agreement. With respect to the remaining variable consideration within the Merck Agreement, including milestone and royalty payments, the Company determined that as of December 31, 2023 these payments were probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control.
Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 127 Balance Sheets 128 Statements of Operations and Comprehensive Loss 129 Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 130 Statements of Cash Flows 131 Notes to Financial Statements 132 126 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of Janux Therapeutics, Inc.
Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 125 Balance Sheets 126 Statements of Operations and Comprehensive Loss 127 Statements of Stockholders’ Equity 128 Statements of Cash Flows 129 Notes to Financial Statements 130 124 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of Janux Therapeutics, Inc.
Notes to Financial Statements - (Continued) facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources.
These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources.
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, 2021: Assets: Cash equivalents: Money market funds $ 15,020 $ 15,020 $ $ Commercial paper 9,998 9,998 Total cash equivalents 25,018 15,020 9,998 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, 2022: Assets: Cash equivalents: Money market funds $ 12,697 $ 12,697 $ $ Total cash equivalents 12,697 12,697 Short-term investments: U.S.
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, 2022 and 2021. At December 31, 2022 , the Company had federal and state net operating loss ("NOL") carryforwards of $ 50.0 million and $ 82.0 million, respectively.
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, 2023 and 2022. At December 31, 2023 , the Company had federal and state net operating loss ("NOL") carryforwards of $ 49.9 million and $ 117.6 million, respectively.
Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, for employees, which is an average of the contractual term of the option and its vesting period. The expected term for nonemployee options is generally the contractual term. Expected dividend yield .
Because the Company does not have sufficient historical exercise behavior to provide a reasonable basis upon which to estimate the expected term, it determines the expected life assumption using the simplified method, for employees, which is an average of the contractual term of the option and its vesting period. The expected term for nonemployee options is generally the contractual term.
Notes to Financial Statements - (Continued) The following tables summarize short-term investments (in thousands): As of December 31, 2022 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
The following tables summarize short-term investments (in thousands): As of December 31, 2023 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
The Company has excluded weighted-average unvested shares of 182,194 shares and 445,326 shares from the weighted-average number of common shares outstanding for the years ended December 31, 2022 and 2021, respectively.
The Company has excluded weighted-average unvested shares of 27,458 shares and 182,194 shares from the weighted-average number of shares of common stock outstanding for the years ended December 31, 2023 and 2022, respectively.
Utilization of the Company's NOL and R&D credit carryforwards may be subject to substantial annual limitations in the event a cumulative ownership change has occurred, or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the "Code").
The state R&D credit carryforwards do not expire. Utilization of the Company's NOL and R&D credit carryforwards may be subject to substantial annual limitations in the event a cumulative ownership change has occurred, or that could occur in the future, as required by Section 382 of the Internal Revenue Code 145 Table of Contents Janux Therapeutics, Inc.
Income Taxes The Company has no t recorded a current or deferred tax expense or benefit for the years ended December 31, 2022 or 2021. The net losses for the years ended December 31, 2022 and 2021 were generated solely in the United States.
Notes to Financial Statements - (Continued) The Company has no t recorded a current or deferred tax expense or benefit for the years ended December 31, 2023 or 2022. The net losses for the years ended December 31, 2023 and 2022 were generated solely in the United States.
If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer.
If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer.
The Company estimates the remaining term of these research services, over which revenue will be recognized, t o be 0.3 years for the First Collaboration Target and 1.7 years for th e Second Collaboration Target as of December 31, 2022.
The Company estimates the remaining term of these research services, over which revenue will be recognized, t o be 0.7 years for th e Second Collaboration Target as of December 31, 2023. The Company recognized $ 8.1 million and $ 8.6 million of revenue under the Merck Agreement for the years ended December 31, 2023 and 2022, respectively.
Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis.
Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as 130 Table of Contents Janux Therapeutics, Inc.
As of December 31, 2022 , total unrecognized stock-based compensation expense related to the ESPP was $ 1.4 million, which is expected to be recognized over a remaining weighted-average period of approximately 1.7 years.
As of December 31, 2023 , total unrecognized stock-based compensation expense related to the ESPP was $ 0.7 million, which is expected to be recognized over a remaining weighted-average period of approximately 1.6 years. 142 Table of Contents Janux Therapeutics, Inc.
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): Year Ended December 31, 2022 2021 Expected tax benefit computed at federal statutory rate $ ( 13,242 ) $ ( 6,861 ) State income taxes, net of federal tax benefit ( 3,754 ) ( 2,169 ) Permanent differences 1,899 324 Research and development credits ( 2,930 ) ( 745 ) Reserve for uncertain tax positions 715 253 Other 80 328 Change in valuation allowance 17,232 8,870 Income tax expense (benefit) $ $ Significant components of the Company’s net deferred tax assets (liabilities) are summarized as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 16,261 $ 11,134 Research and development credit carryforwards 3,377 1,179 Stock-based compensation 3,453 1,273 Lease liability 7,081 Capitalized research and development 8,310 54 Other 430 77 Total deferred tax assets 38,912 13,717 Valuation allowance ( 30,976 ) ( 13,390 ) Net deferred tax assets 7,936 327 Deferred tax liabilities: Property and equipment ( 1,519 ) ( 106 ) ROU asset ( 6,235 ) Other ( 182 ) ( 221 ) Total gross deferred tax liabilities ( 7,936 ) ( 327 ) Net deferred tax assets $ $ Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income.
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): Year Ended December 31, 2023 2022 Expected tax benefit computed at federal statutory rate $ ( 12,242 ) $ ( 13,242 ) State income taxes, net of federal tax benefit ( 2,827 ) ( 3,754 ) Permanent differences 3,567 1,899 Research and development credits ( 4,300 ) ( 2,930 ) Reserve for uncertain tax positions 1,058 715 Other 124 80 Change in valuation allowance 14,620 17,232 Income tax expense (benefit) $ $ Significant components of the Company’s net deferred tax assets (liabilities) are summarized as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 18,745 $ 16,261 Capitalized research and development 15,698 8,310 Lease liability 6,868 7,081 Research and development credit carryforwards 6,597 3,377 Stock-based compensation 4,005 3,453 Other 713 430 Total deferred tax assets 52,626 38,912 Valuation allowance ( 44,981 ) ( 30,976 ) Net deferred tax assets 7,645 7,936 Deferred tax liabilities: ROU asset ( 5,831 ) ( 6,235 ) Property and equipment ( 1,498 ) ( 1,519 ) Other ( 316 ) ( 182 ) Total gross deferred tax liabilities ( 7,645 ) ( 7,936 ) Net deferred tax assets $ $ Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income.
Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain.
Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expense and expensed as incurred since recoverability of such expenditures is uncertain. Stock-Based Compensation 136 Table of Contents Janux Therapeutics, Inc.
The most significant estimates in the Company’s financial statements relate to estimates to complete the performance obligations and the estimated transaction price for collaboration revenue, accruals for research and development expenses, stock-based compensation and fair value measurements. These estimates and assumptions are based on current 132 Table of Contents Janux Therapeutics, Inc.
The most significant estimates in the Company’s financial statements relate to estimates to complete the performance obligations and the estimated transaction price for collaboration revenue, accruals for research and development expenses, stock-based compensation and fair value measurements.
Treasury securities $ 63,675 $ $ ( 659 ) $ 63,016 U.S. agency bonds 67,421 ( 401 ) 67,020 U.S. agency discount notes 4,321 13 4,334 Corporate debt securities 1,975 ( 5 ) 1,970 Commercial paper 139,733 26 ( 509 ) 139,250 Total $ 277,125 $ 39 $ ( 1,574 ) $ 275,590 As of December 31, 2021 Amortized Unrealized Estimated Cost Gains Losses Fair Value U.S.
Treasury securities $ 63,675 $ $ ( 659 ) $ 63,016 U.S. agency bonds 67,421 ( 401 ) 67,020 U.S. agency discount notes 4,321 13 4,334 Corporate debt securities 1,975 ( 5 ) 1,970 Commercial paper 139,733 26 ( 509 ) 139,250 Total $ 277,125 $ 39 $ ( 1,574 ) $ 275,590 The amortized cost and estimated fair value in the tables above exclude $ 2.2 million and $ 0.7 million of accrued interest receivable as of December 31, 2023 and 2022, respectively.
Employee contributions are voluntary and determined on an individual basis, limited to the maximum amount allowable under federal tax regulations. Under the plan, the Company makes a mandatory annual contribution of up to 3 % of eligible employees’ compensation. Employer contributions for the years ended December 31, 2022 and 2021 were immaterial. 147 It em 9.
Employee contributions are voluntary and determined on an individual basis, limited to the maximum amount allowable under federal tax regulations. Under the plan, the Company makes a mandatory annual contribution of up to 3 % of eligible employees’ compensation.
In those 137 Table of Contents Janux Therapeutics, Inc. Notes to Financial Statements - (Continued) instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable.
In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable.
Treasury securities 63,016 63,016 U.S. agency bonds 67,020 67,020 U.S. agency discount notes 4,334 4,334 Corporate debt securities 1,970 1,970 Commercial paper 139,250 139,250 Total short-term investments 275,590 63,016 212,574 Restricted cash: Money market account 816 816 Total restricted cash 816 816 Total assets measured at fair value on a recurring basis $ 289,103 $ 76,529 $ 212,574 $ 133 Table of Contents Janux Therapeutics, Inc.
Treasury securities 63,016 63,016 U.S. agency bonds 67,020 67,020 U.S. agency discount notes 4,334 4,334 Corporate debt securities 1,970 1,970 Commercial paper 139,250 139,250 Total short-term investments 275,590 63,016 212,574 Restricted cash: Money market account 816 816 Total restricted cash 816 816 Total assets measured at fair value on a recurring basis $ 289,103 $ 76,529 $ 212,574 $ Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents.
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, 2022 2021 Cash and cash equivalents $ 51,426 $ 35,582 Restricted cash 816 816 Total cash and cash equivalents and restricted cash $ 52,242 $ 36,398 Short-Term Investments Short-term investments consist of U.S. treasury securities, U.S. agency bonds, U.S. agency discount notes, corporate debt securities and commercial paper.
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, 2023 2022 Cash and cash equivalents $ 19,205 $ 51,426 Restricted cash 816 816 Total cash and cash equivalents and restricted cash $ 20,021 $ 52,242 Short-Term Investments Short-term investments consist of U.S.
A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract.
A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the 135 Table of Contents Janux Therapeutics, Inc.
Although the impact of the COVID-19 pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its accounting estimates. Actual results may differ materially and adversely from these estimates.
The Company continues to use the best information available to update its accounting estimates. Actual results may differ materially and adversely from these estimates.
Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation.
If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation. The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer.
The Company plans to continue to fund its losses from operations and capital funding needs through public or private equity or debt financings or other sources. The COVID-19 pandemic continues to evolve and has resulted in a significant disruption of global capital markets.
The Company plans to continue to fund its losses from operations and capital funding needs through public or private equity or debt financings or other sources.
Treasury securities $ 57,369 $ 5,647 U.S. agency bonds 37,202 29,818 U.S. agency discount notes 4,334 Corporate debt securities 1,970 Commercial paper 139,250 Total $ 238,155 $ 37,435 As of December 31, 2021 Due in 1 Year or Less Due Between 1 and 2 Years U.S.
Treasury securities $ 57,369 $ 5,647 U.S. agency bonds 37,202 29,818 U.S. agency discount notes 4,334 Corporate debt securities 1,970 Commercial paper 139,250 Total $ 238,155 $ 37,435 133 Table of Contents Janux Therapeutics, Inc.
Bal ance Sheets (in thousands, except share and par value data) December 31, Assets 2022 2021 Current assets: Cash and cash equivalents $ 51,426 $ 35,582 Short-term investments 275,590 339,383 Prepaid expenses and other current assets 5,423 2,054 Total current assets 332,439 377,019 Restricted cash 816 816 Property and equipment, net 7,086 1,412 Operating lease right-of-use assets 22,279 185 Other long-term assets 1,390 392 Total assets $ 364,010 $ 379,824 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,159 $ 2,458 Accrued liabilities 8,010 3,779 Current portion of deferred revenue 5,406 5,163 Unvested stock liabilities 169 1,203 Current portion of operating lease liabilities 763 194 Total current liabilities 16,507 12,797 Deferred revenue, net of current portion 2,221 700 Operating lease liabilities, net of current portion 24,542 Total liabilities 43,270 13,497 Commitments and contingencies (Note 3) Stockholders’ equity: Preferred stock, $ 0.001 par value; authorized shares 10,000,000 at December 31, 2022 and 2021, respectively; no shares issued and outstanding at December 31, 2022 and 2021 Common stock, $ 0.001 par value; authorized shares 200,000,000 at December 31, 2022 and 2021, respectively; issued shares 41,684,666 and 41,622,962 at December 31, 2022 and 2021, respectively; outstanding shares 41,616,260 and 41,243,137 at December 31, 2022 and 2021, respectively 42 41 Additional paid-in capital 432,703 413,967 Accumulated other comprehensive loss ( 1,535 ) ( 270 ) Accumulated deficit ( 110,470 ) ( 47,411 ) Total stockholders’ equity 320,740 366,327 Total liabilities and stockholders’ equity $ 364,010 $ 379,824 See accompanying notes. 128 Table of Contents Janux Therapeutics, Inc.
Bal ance Sheets (in thousands, except share and par value data) December 31, Assets 2023 2022 Current assets: Cash and cash equivalents $ 19,205 $ 51,426 Short-term investments 324,823 275,590 Prepaid expenses and other current assets 5,213 5,423 Total current assets 349,241 332,439 Restricted cash 816 816 Property and equipment, net 7,003 7,086 Operating lease right-of-use assets 20,838 22,279 Other long-term assets 2,509 1,390 Total assets $ 380,407 $ 364,010 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,424 $ 2,159 Accrued expenses 7,387 8,179 Current portion of deferred revenue 1,705 5,406 Current portion of operating lease liabilities 1,517 763 Total current liabilities 13,033 16,507 Deferred revenue, net of current portion 2,221 Operating lease liabilities, net of current portion 23,025 24,542 Total liabilities 36,058 43,270 Commitments and contingencies (Note 3) Stockholders’ equity: Preferred stock, $ 0.001 par value; authorized shares 10,000,000 at December 31, 2023 and 2022, respectively; no shares issued and outstanding at December 31, 2023 and 2022 Common stock, $ 0.001 par value; authorized shares 200,000,000 at December 31, 2023 and 2022, respectively; issued shares 46,262,759 and 41,684,666 at December 31, 2023 and 2022, respectively; outstanding shares 46,252,440 and 41,616,260 at December 31, 2023 and 2022, respectively 46 42 Additional paid-in capital 512,401 432,703 Accumulated other comprehensive income (loss) 665 ( 1,535 ) Accumulated deficit ( 168,763 ) ( 110,470 ) Total stockholders’ equity 344,349 320,740 Total liabilities and stockholders’ equity $ 380,407 $ 364,010 See accompanying notes. 126 Janux Therapeutics, Inc.
As of December 31, 2022, there w ere 6,676,843 s hares authorized for issuance under the 2021 Plan, inclusive of shares added from 2017 Plan cancellations. 142 Table of Contents Janux Therapeutics, Inc.
As of December 31, 2023, there w ere 9,169,849 s hares authorized for issuance under the 2021 Plan, inclusive of shares added from 2017 Plan cancellations.
The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer.
To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money.

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