Jade Biosciences (JBIO) risk factors, FY2025 10-K

What changed since the prior 10-K

New

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We are a clinical stage biotechnology company with a limited operating history on which to assess our business; we have not completed any clinical trials, and we have no products approved for commercial sale, which may make it difficult to evaluate our current business and likelihood of success and viability

  We are a clinical-stage biotechnology company with no approved products, no commercial revenue, and limited operating history, making our future success difficult to evaluate.

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  activities necessary for successful product commercialization. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history

  We may encounter unforeseen difficulties as we transition from early research to supporting larger-scale clinical trials and commercial activities.

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts

  We will need substantial additional capital to fund our expensive development programs and commercialization efforts, and may be forced to delay them if funds are unavailable.

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  the costs of operating as a public company

  Our existing cash is expected to fund operations for at least twelve months from December 31, 2025, but we will need to raise additional capital, raising going concern doubts.

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We expect to continue to incur losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have no products approved for sale, have not generated any revenue from our product candidates and may never generate revenue or become profitable

  We expect to continue incurring losses and may never achieve profitability since we have no approved products and generate no revenue.

• NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  operate as a public company

  Our expenses will increase due to public company costs, potential FDA-mandated trials, or intellectual property defense.

• NewRisks Related to Our Discovery, Development and Commercialization

  We face competition from entities that have developed or may develop products for the diseases addressed by our product candidates

  We face intense competition from multinational biopharmaceutical companies and specialized firms like Biogen, Novartis, and Vertex, many with greater resources.

• NewRisks Related to Our Discovery, Development and Commercialization

  the FDA or other regulatory authorities may require us to submit additional data, such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial

  The FDA or foreign regulators may require additional data, such as long-term toxicology studies, before allowing us to start clinical trials.

• NewRisks Related to Our Discovery, Development and Commercialization

  We are substantially dependent on the success of JADE101, and our current and anticipated future clinical trials of such product candidate may not be successful

  Our future success depends heavily on JADE101, which entered a Phase 1 trial in healthy volunteers in New Zealand in August 2025.

• NewRisks Related to Our Discovery, Development and Commercialization

  If we do not achieve our projected development objectives in the time frames we announce and expect, the commercialization of our product candidates may be delayed which may harm our reputation and prospects, increase our expenses and cause our stock price to decline

  Failure to meet projected development milestones, such as Phase 2 trials for JADE101 or Phase 1 trials for JADE201 and JADE301, could harm our stock price.

• NewRisks Related to Our Discovery, Development and Commercialization

  Our approach to the discovery and development of our product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value

  Our unproven discovery approach uses monoclonal antibody half-life extension and binding affinity enhancements that may not yield safe or effective long-term treatments.

• NewRisks Related to Our Discovery, Development and Commercialization

  the risk that enrolled participants will drop out of our trials prior to completion

  Difficulties in enrolling or maintaining a sufficient number of participants in our clinical trials could result in significant delays and increased costs.

• NewRisks Related to Our Discovery, Development and Commercialization

  We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success

• NewRisks Related to Our Discovery, Development and Commercialization

  Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue

• NewRisks Related to Our Discovery, Development and Commercialization

  We plan to conduct clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations

• NewRisks Related to Our Reliance on Third Parties

  We rely on collaborations and licensing arrangements with third parties, including Paragon. If we are unable to maintain these collaborations or licensing arrangements, or if these collaborations or licensing arrangements are not successful, our business could be negatively impacted

• NewRisks Related to Our Reliance on Third Parties

  Fairmount beneficially owns more than 5% of the Company’s capital, currently has two representatives appointed to the Board and beneficially owns more than 5% of Paragon

• NewRisks Related to Our Reliance on Third Parties

  Risks associated with the in-licensing or acquisition of product candidates could cause substantial delays in the preclinical and clinical development of our product candidates

• NewRisks Related to Our Reliance on Third Parties

  and delays in the development of our product candidates, which could adversely affect any future revenue from such product candidates, if approved

• NewRisks Related to Our Reliance on Third Parties

  Our reliance on foreign CROs and CMOs may increase the risks associated with our development programs

• NewRisks Related to Our Business and Operations

  In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth

• NewRisks Related to Our Business and Operations

  We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy

• NewRisks Related to Our Business and Operations

  Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties

• NewRisks Related to Our Business and Operations

  Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all

• NewRisks Related to Our Business and Operations

  Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

• NewRisks Related to Our Business and Operations

  In the U.S., we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA. Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA

• NewRisks Related to Our Business and Operations

  Our business may be affected by the evolving regulatory framework for AI Technologies

• NewRisks Related to Our Business and Operations

  technologies increases regulatory, cybersecurity and other significant risks. There can be no assurance that the usage of or our investments in such technologies will always be beneficial to our business, including our efficiency or profitability

• NewRisks Related to Our Business and Operations

  If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business

• NewRisks Related to Our Business and Operations

  We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition

• NewRisks Related to Our Business and Operations

  We may acquire businesses, product candidates or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions or alliances

• NewRisks Related to Our Business and Operations

  We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments

• NewRisks Related to Our Intellectual Property

  If we are unable to obtain or maintain necessary rights to our programs through acquisitions and in-licenses, our business may be materially harmed

• NewRisks Related to Our Intellectual Property

  We may be subject to intellectual property lawsuits or may need to file lawsuits to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products

• NewRisks Related to Our Intellectual Property

  Our success will depend in part on our and our current and future licensors’ ability to obtain, maintain and enforce patent protection for our licensed intellectual property

• NewRisks Related to Our Intellectual Property

  Patent terms may be inadequate to protect our competitive position of our product candidates for an adequate amount of time

• NewRisks Related to Our Intellectual Property

  Our technology licensed from various third parties may be subject to retained rights

• NewRisks Related to Government Regulation

  such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission

• NewRisks Related to Government Regulation

  We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates

• NewRisks Related to Government Regulation

  Our product candidates for which we intend to seek approval as biologics may face competition from biosimilars sooner than anticipated

• NewRisks Related to Government Regulation

  The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses

• NewRisks Related to Government Regulation

  We may face difficulties from healthcare and regulatory legislative reform measures

• NewRisks Related to Government Regulation

  statutory exception or regulatory safe harbor does not make the conduct per se illegal under the AKS. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances

• NewRisks Related to Government Regulation

  We are also subject to additional similar U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts

• NewRisks Related to Government Regulation

  Even if we are able to commercialize any product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such product candidates at competitive prices, which would seriously harm our business

• NewRisks Related to Government Regulation

  competitor’s product, including a branded or generic/biosimilar product, over our products in an attempt to reduce their costs, which may reduce our commercial opportunity. See “Business—Government Regulation—Coverage and Reimbursement”

• NewRisks Related to Government Regulation

  Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any

• NewRisks Related to Government Regulation

  We may become exposed to costly and damaging liability claims, when testing a product candidate in the clinical stage or at the commercial stage, and our product liability insurance may not cover all damages from such claims

• NewRisks Related to Government Regulation

  Litigation costs and the outcome of litigation could have a material adverse effect on our business

• NewRisks Related to Government Regulation

  Our business could be adversely affected by economic downturns, inflation, fluctuating interest rates, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition

• NewRisks Related to the Ownership of Our Common Stock

  The market price of our common stock has been and is expected to continue to be volatile

• NewRisks Related to the Ownership of Our Common Stock

  period-to-period fluctuations in our financial results

• NewRisks Related to the Ownership of Our Common Stock

  We are governed by Nevada law and our articles of incorporation and bylaws, provisions of which have anti-takeover implications

• NewRisks Related to the Ownership of Our Common Stock

  Because our articles of incorporation and bylaws limit the court in which you may bring an action against us, you may have difficulty obtaining a more favorable judicial forum or you may incur more expense enforcing any rights which you may claim as compared to another forum

• NewRisks Related to the Ownership of Our Common Stock

  We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies

• NewRisks Related to the Ownership of Our Common Stock

  Once we are no longer a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results and cash flows

• NewRisks Related to the Ownership of Our Common Stock

  If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired

• NewRisks Related to the Ownership of Our Common Stock

  We do not anticipate that we will pay any cash dividends in the foreseeable future

• NewRisks Related to the Ownership of Our Common Stock

  Future sales of shares by existing stockholders could cause our stock price to decline

• NewRisks Related to the Ownership of Our Common Stock

  Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval

• NewRisks Related to the Ownership of Our Common Stock

  Conflicts of interest may arise between us and Paragon or us and Fairmount

• NewRisks Related to the Ownership of Our Common Stock

  If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, then our stock price and trading volume could decline

• NewRisks Related to the Ownership of Our Common Stock

  The class structure of our capital stock may limit your ability to influence corporate matters and may limit your visibility with respect to certain transactions

• NewRisks Related to the Ownership of Our Common Stock

  We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors

Dropped

• DroppedRisks Related to the Merger

  Failure to complete, or delays in completing, the potential Merger with Jade, announced on October 31, 2024, could materially and adversely affect our or Jade’s results of operations, business, financial results and may cause a decline in the market price of our common stock

  Failure to complete or delays in the merger with Jade announced October 31, 2024.

• DroppedRisks Related to the Merger

  We may not be successful in consummating the Merger

  Halting enrollment and shutting down the Phase 3 trial of AV-101 for PAH.

• DroppedRisks Related to the Merger

  Although there can be no assurance that the Merger will be completed, the negotiation and consummation of the Merger will require significant time on the part of our management, and the diversion of management’s attention may disrupt our business

  Management time diversion and operational/financial risks from merger negotiations.

• DroppedRisks Related to the Merger

  Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects

  Board potentially pursuing dissolution and liquidation if the merger is not completed.

• DroppedRisks Related to the Merger

  Failure to complete the Merger may result in either Jade or us paying a termination fee to the other party, and could harm our common stock price and future business and operations of each company

  Termination fees of $2.34 million or $5.25 million payable under specific merger circumstances.

• DroppedRisks Related to the Merger

  If the conditions to the Merger are not satisfied or waived, the Merger may not occur

  Merger not occurring if closing conditions are not satisfied or waived.

• DroppedRisks Related to the Merger

  We and Jade may mutually agree to waive the condition to the Merger requiring approval for listing on Nasdaq, and if such condition is waived, the combined company’s stock may not be listed on Nasdaq following completion of the Merger

  Stock not being listed on Nasdaq if listing condition is waived.

• DroppedRisks Related to the Merger

  The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes

  Material adverse effect exclusions allowing merger completion despite industry changes.

• DroppedRisks Related to the Merger

  If we and Jade complete the Merger, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations

  Need to raise additional capital post-merger causing significant dilution or restrictions.

• DroppedRisks Related to the Merger

  Some of Jade’s and our directors and executive officers have interests in the Merger that are different from our other stockholders

  Directors and executive officers having different or additional interests in the merger.

• DroppedRisks Related to the Merger

  Our stockholders and Jade stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger, including the conversion of Jade common stock issued in the Jade Pre-Closing Financing

  Stockholders experiencing ownership dilution without commensurate benefit from the merger.

• DroppedRisks Related to the Merger

  If the Merger is not completed, our stock price may decline significantly

  Stock price decline if the merger is not completed.

• DroppedRisks Related to the Merger

  Our securityholders and Jade securityholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies

• DroppedRisks Related to the Merger

  During the pendency of the Merger, we and Jade may not be able to enter into a business combination with another party on more favorable terms because of restrictions in the Merger Agreement, which could adversely affect their respective business prospects

• DroppedRisks Related to the Merger

  Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement

• DroppedRisks Related to the Merger

  Lawsuits may be filed against us, Jade, or any of the members of our or Jade’s boards of directors arising out of the Merger, which may delay or prevent the Merger

• DroppedRisks Related to the Merger

  Our ability to consummate the Merger depends on our ability to retain the employees required to consummate such transaction

• DroppedRisks Related to the Merger

  92% of our workforce was terminated as of December 31, 2024. Our cash conservation activities may yield unintended consequences, such as attrition beyond our Workforce Reduction Plan and reduced employee morale, which may cause remaining employees to seek alternative employment

• DroppedRisks Related to the Merger

  Our cash preservation activities, including the Workforce Reduction Plan, may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business

• DroppedRisks Related to the Merger

  We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages

• DroppedRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We are a biopharmaceutical company with a limited operating history

• DroppedRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We have incurred significant operating losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We may never achieve or maintain profitability

• DroppedRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  We have no products approved for commercial sale and have not generated any revenue from product sales

• DroppedRisks Related to Our Limited Operating History, Financial Position and Capital Requirements

  Since our inception, we have invested substantially all of our efforts and financial resources in the development of AV-101 to address the core disease processes of PAH. We do not intend to resume development of AV-101 or conduct research on additional product candidates at this time

• DroppedRisks Related to the Research and Development Activities

  The results of earlier studies and trials may not be predictive of future trial results

• DroppedRisks Related to Our Intellectual Property

  applications or to maintain, defend and enforce any patents that may issue from such patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection

• DroppedRisks Related to Our Intellectual Property

  Intellectual property litigation could cause us to spend substantial resources and prevent us from pursuing our programs

• DroppedRisks Related to Our Intellectual Property

  Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties

• DroppedRisks Related to Our Intellectual Property

  Third parties may initiate or threaten legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business

• DroppedRisks Related to Our Intellectual Property

  If we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation cannot be obtained to extend the patent protection for a product candidate, business operations may be materially harmed

• DroppedRisks Related to Our Intellectual Property

  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

• DroppedRisks Related to Our Intellectual Property

  If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed

• DroppedRisks Related to Our Intellectual Property

  If we and our partners do not adequately protect the trademarks and trade names for our products, then we and our partners may not be able to build name recognition in our markets of interest and our business may be adversely affected

• DroppedRisks Related to Government Regulation

  We may be unable to obtain regulatory approval under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of any product candidates and adversely impact our potential to generate revenue, our business and our results of operations

• DroppedRisks Related to Government Regulation

  Of the large number of pharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’ approval processes and are commercialized

• DroppedRisks Related to Government Regulation

  Should we in the future conduct clinical trials outside the United States, and the FDA, EMA and applicable foreign regulatory authorities may not accept data from such trials

• DroppedRisks Related to Government Regulation

  also must submit new or supplemental applications and obtain approval for certain changes to product labeling, or manufacturing process

• DroppedRisks Related to Government Regulation

  We have received orphan drug designation from the FDA and EMA for AV-101 for treatment of PAH, but we may be unable to obtain additional designations or to maintain the benefits associated with orphan drug status, including the potential for non-patent market exclusivity

• DroppedRisks Related to Government Regulation

  Even if FDA approval is obtained in the United States, it does not guarantee approval for or successful commercialization of a product candidate outside of the United States, which would limit the ability to realize its full market potential

• DroppedRisks Related to Government Regulation

  Healthcare legislative reform measures may have a material adverse effect on our business and results of operations

• DroppedRisks Related to Employee Matters

  Our insurance policies may be inadequate and potentially expose us to unrecoverable risks

• DroppedRisks Related to Employee Matters

  laws), federal, and international law and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our business

• DroppedRisks Related to Ownership of Our Common Stock

  Changes in tax law may adversely affect us or our investors

• DroppedRisks Related to Ownership of Our Common Stock

  Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management

• DroppedRisks Related to Ownership of Our Common Stock

  Our amended and restated bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees

• DroppedRisks Related to Ownership of Our Common Stock

  Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations

• DroppedRisks Related to Ownership of Our Common Stock

  raise additional capital as needed on acceptable terms, if at all. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could adversely impact our business

• DroppedRisks Related to Ownership of Our Common Stock

  Our business is affected by macroeconomic conditions, including rising inflation, interest rates and supply chain constraints

• DroppedRisks Related to Ownership of Our Common Stock

  Actual or perceived failures to comply with United States and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance

• DroppedRisks Related to Ownership of Our Common Stock

  We may not pay any cash dividends on our capital stock in the foreseeable future, other than the Cash Dividend in connection with the Merger, and capital appreciation, if any, will be our stockholders’ sole source of gain

• DroppedRisks Related to Ownership of Our Common Stock

  We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives

• DroppedRisks Related to Ownership of Our Common Stock

  If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed

• DroppedRisks Related to Ownership of Our Common Stock

  Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud

• DroppedRisks Related to Ownership of Our Common Stock

  If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline

Reworded

• 100% rewrittenRisks Related to Our Intellectual Property

  We may become subject to claims challenging the inventorship or ownership of our patents, if issued, and other intellectual property

  Updated to specifically warn about inventorship and co-inventorship claims from former employees and collaborators invalidating future patents, and added mention of foreign laws.

  Was: We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property

• 100% rewrittenRisks Related to the Ownership of Our Common Stock

  Our ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of our recent merger

  Updated federal and state NOL carryforward details as of December 31, 2025, noting post-2017 federal NOLs are carried forward indefinitely but limited to 80% of taxable income.

  Was: Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited

• 95% rewrittenRisks Related to Our Intellectual Property

  Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products

  Clarified risks regarding the Leahy-Smith America Invents Act and its specific provisions affecting patent prosecution, prior art redefinition, and post-grant USPTO proceedings.

  Was: Changes in patent law could diminish the value of patents in general, thereby impairing the ability to protect product candidates

• 92% rewrittenRisks Related to Government Regulation

  Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties

  Added specific references to the federal Anti-Kickback Statute, False Claims Act, and HIPAA alongside general healthcare regulatory laws.

  Was: Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers have been subject to applicable healthcare regulatory laws, which could expose us to penalties

• 86% rewrittenRisks Related to Our Discovery, Development and Commercialization

  Preliminary, “topline” or interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures

  Added specific warning that preliminary or topline data remain subject to audit and verification procedures and should be viewed with caution.

  Was: Interim, topline and preliminary results from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data

• 82% rewrittenRisks Related to Our Intellectual Property

  We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products

  Refined language regarding how patent claim scope is determined through law, written disclosures, prosecution history, and extrinsic evidence.

  Was: We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop, manufacture and market our product candidate

• 75% rewrittenRisks Related to Our Intellectual Property

  Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements

  Expanded to explicitly list periodic maintenance fees, renewal fees, and annuity fees required by the USPTO and foreign patent agencies.

  Was: Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements

• 33% rewrittenRisks Related to Our Intellectual Property

  We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

  Added specific mention that the company engages consultants who were previously employed by or consult for competitors, increasing wrongful disclosure risks.

  Was: We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

All 72 risk factors

Headings as the filing states them, in filing order.

Other Jade Biosciences 10-Ks

• FY2024 10-K risk factors

  62 risks

  Jade Biosciences has a limited operating history and incurred cumulative operating losses of $233.1 million through December 31, 2024. The company halted the Phase 3 clinical trial of its sole product candidate AV-101 for pulmonary arterial hypertension in June 2024. Operations are heavily focused on completing a pending merger with Jade and executing a $300.0 million pre-closing financing.

  Filed Mar 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.