Enliven Therapeutics, Inc. Common Stock

Tax and financial reporting · Tax compliance and changes in tax law

Changes in tax laws, including changes to tax rates, tax treaties, and regulations or their interpretation, may cause us to experience fluctuations in our tax obligations and effective tax rates and otherwise may adversely affect our business, operating results, or financial condition.

Data and privacy · Consumer privacy and consent

We maintain sensitive personally identifiable information, including health and genetic information, that we receive throughout the clinical trial process and in the course of our research collaborations. Individuals from whom we or our collaborators may obtain personal information may have statutory or contractual rights that require certain security measures to protect such information.

Legal and litigation · Employment and labor law compliance

Our relationships with employees, independent contractors, consultants, commercial collaborators, healthcare professionals, clinical investigators, CROs, suppliers, vendors and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws.

Data and privacy · Data protection and privacy laws

We are subject to stringent and changing privacy, data protection and data security laws, regulations and standards as well as policies, contracts and other obligations related to data privacy, data protection and data security. Our actual or perceived failure to comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties), a disruption or cancellation of clinical trials or commercialization of products, reputational harm, or other adverse business effects.

Technology infrastructure · Disaster recovery and business continuity

We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major blizzard, flood, fire, earthquake, power loss, telecommunications failure, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters.

Cybersecurity and data protection · Data breaches and cyber attacks

Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or data privacy incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal information, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.

Supply chain and procurement · Geographic concentration of suppliers

We currently use CMOs based in China and Europe and may add additional CMOs or transition the manufacturing of our product candidate(s) to CMOs based in other countries, which can increase our business expenses. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries.

Human capital and workforce · Talent acquisition and retention

Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees. We are highly dependent on the principal members of our management and medical staff, particularly Rick Fair, our President, Chief Executive Officer and director, Ben Hohl, our Chief Financial Officer and Helen Collins, our Chief Medical Officer.

Project and contract management · Project execution and delivery risks

We have limited experience as a company in designing and conducting clinical trials. We are currently evaluating ELVN-001 in a Phase 1 clinical trial in adults with CML. We cannot be certain that our ongoing and planned preclinical studies and clinical trials will be completed on time, that we will successfully or cost-effectively design and implement clinical trials that achieve the desired clinical endpoints efficiently, or at all.

Supply chain and procurement · Raw material availability and cost volatility

Any supply interruption in limited or sole sourced materials could materially harm our ability to manufacture our product candidates until a new source of supply, if any, could be identified and qualified. We may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms.

Human capital and workforce · Key personnel dependence and succession

We do not maintain 'Key Person' insurance for any of our executives or other employees. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan and harm our operating results.

Geopolitical and trade · Government funding and budget changes

Inadequate funding, layoffs, government shutdown, staff departures, lapse in government appropriations, and other policies impacting the normal operations of the FDA, the SEC and other United States government agencies or the EMA or comparable foreign regulatory authorities could hinder their ability to hire and retain key leadership and other personnel.

Natural and catastrophic events · Natural disasters and extreme weather

Our office facilities are located in Colorado. We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major blizzard, flood, fire, earthquake, power loss, telecommunications failure, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters.

Natural and catastrophic events · Pandemic and public health crises

We face risks related to public health emergencies, health epidemics (including COVID-19) or other outbreaks, which could significantly disrupt our operations or otherwise result in material adverse impacts to us, including delays or difficulties in clinical site initiation and interruption of key preclinical and clinical trial activities.

Strategic execution · Geographic expansion and market entry

A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business, including differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the United States.

Market position and competition · Pricing pressure and margin compression

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product candidates.

Market position and competition · Disruptive competitors and new market entrants

We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Customer and revenue · Reimbursement and pricing pressure healthcare or insurance

Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations. The availability and extent of coverage and adequate reimbursement by third-party payors is essential for most patients to be able to afford expensive treatments.

Market position and competition · Competitive pressure and market share loss

We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do. There are currently six BCR-ABL TKIs approved for use in CML by the FDA, and there are investigational agents in clinical trials for CML.

Capital structure and performance · Financial performance volatility

We have incurred significant net losses and we expect to continue to incur significant net losses for the foreseeable future. Our net loss was $103.7 million for the year ended December 31, 2025. As of December 31, 2025, we had an accumulated deficit of $347.2 million.