Item 1B. Unresolved Staff Comments
Item 1B. Unresolved Staff Comments.
Not Applicable.
Item 1C. Cybersecurity.
Cybersecurity Risk Management and Strategy
We have developed and implemented a cybersecurity governance program intended to protect the confidentiality, integrity, and availability of our critical systems and information.
We design and assess our program based on the National Institute of Standards and Technology Cybersecurity Framework (NIST CSF). This does not imply we meet any particular technical standards, specifications, or requirements, only that we use the NIST CSF as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
Our cybersecurity governance program includes reporting channels to the executive management team and an internal Cybersecurity Oversight Committee, as well as governance processes which communicate cybersecurity risks to departments across the organization, including legal, strategic, operational, and financial areas. This encourages consideration of cybersecurity oversight, accountability and diligence across the organization.
Key elements of our cybersecurity governance program includes but are not limited to the following:
• processes to assess cybersecurity risk, designed to help identify material risks from cybersecurity threats to critical systems and information;
• a security team principally responsible for coordinating and managing (1) cybersecurity risk evaluation processes, (2) implementation of cybersecurity controls, and (3) response to cybersecurity incidents;
• the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of the organization’s cybersecurity processes;
• cybersecurity awareness training of employees, including incident response personnel including third party providers, and senior management;
• a cybersecurity incident response plan which includes procedures for responding to cybersecurity incidents; and
• a third-party risk management process for key service providers based on our assessment of their criticality to our operations and respective risk profile.
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We have not identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, which have materially affected us, including our operations, business strategy, results of operations, or financial condition. We face risks from cybersecurity threats that, if realized, are reasonably likely to materially affect the organization, including operations, business strategy, results of operations, or financial condition. See “Risk Factors - Our information technology systems, or those of any of our CROs, manufacturers, other contractors or consultants or Chiesi or potential future collaborators, may fail or suffer security breaches, which could result in a material disruption of our seralutinib development program, which could materially affect our results.”
Cybersecurity Governance
Our Board considers cybersecurity risk as part of its risk oversight function and has delegated to the Audit Committee oversight of cybersecurity risks, including oversight of management’s implementation of the cybersecurity governance program.
The Audit Committee receives formal annual reports from IT management regarding cybersecurity risks. In addition, management would update the Audit Committee and Board, where it deems appropriate, regarding cybersecurity incidents it considers to be significant or potentially significant. The Audit Committee reports to the full Board regarding its activities, including those related to cybersecurity.
Assessment and management of material risks from cybersecurity threats are performed by the Executive Director, Information Security, Risk & Compliance and the Vice President, IT and Facilities, reporting to the Executive Vice President, Technical Operations and Administration. Our Executive Vice President, Technical Operations and Administration reports to the President and Chief Executive Officer. This group holds primary responsibility for our overall cybersecurity governance program, along with our internal Cybersecurity Oversight Committee, which includes senior personnel from key departments in the organization. Individual cybersecurity experience for the group responsible for the program is detailed below. The collective experience of the individuals listed above, along with the Cybersecurity Oversight Committee, includes decades of experience working in and overseeing IT and cybersecurity functions and enterprise, IT and cybersecurity risk management functions, in addition to holding active technical cybersecurity certifications and maintaining active membership in cybersecurity professional organizations, as well as local groups, to support knowledge share and ongoing cybersecurity professional development.
The Executive Vice President, Technical Operations and Administration (EVP) brings more than two decades of senior leadership experience across the biotechnology and pharmaceutical sectors, having served in roles including General Counsel, Managing Director, and Vice President at multiple global life science organizations. The EVP continues to provide strategic oversight of corporate operations, legal governance, and enterprise risk management. In addition the EVP provides active leadership on cybersecurity program maturity, regulatory alignment, and enterprise resilience. This includes evaluation of cybersecurity risk posture, accountability for key IT and security controls, and board level monitoring of cybersecurity operations, incident readiness, and compliance frameworks aligned with industry best practices. The EVP plays a critical role in ensuring organizational integrity, operational continuity, and protection of sensitive scientific, clinical, and corporate information assets.
The Vice President of IT (VP) is a highly experienced technology executive with decades of hands on expertise architecting, deploying, and managing enterprise IT systems in highly regulated and rapidly scaling environments.The VP has designed and implemented Zero Trust frameworks, conditional access models, and cloud first architectures that strengthen organizational security and performance. In addition to hands-on cybersecurity experience, the VP has managed full scope IT operations, including network and systems engineering, enterprise cloud migrations, endpoint lifecycle management, and service delivery excellence. The VP plays a critical role in elevating the organization’s technology posture, enhancing cybersecurity resilience, and delivering secure, reliable, high performance IT environments.
The Executive Director, Information Security, Risk & Compliance (ED) brings over sixteen years of hands on and strategic experience across cybersecurity engineering, governance, risk management, compliance, and IT operations. The ED has led and executed programs spanning technical and business domains, including enterprise business continuity and disaster recovery planning, identity and access management architecture, access administration, security monitoring and incident response, and third party/vendor risk management. Cybersecurity tools administration experience includes endpoint detection and response, cloud security, identity governance, vulnerability management, and Zero Trust–aligned architectures. The ED maintains active CISSP, CISA, and CDPSE certifications. The ED is a member of the local FBI InfraGard chapter, an active member of ISACA, ISC2, and multiple regional CISO executive roundtables. These affiliations support continuous knowledge exchange, including best practice program development, emergent threat intelligence collaboration, and real time peer benchmarking for modern cyber defense strategies.
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Our management team takes steps to stay informed about and monitor efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which may include briefings from internal security personnel; threat intelligence and other information obtained from governmental, public or private sources, including external consultants engaged by us and alerts and reports produced by security tools deployed in our IT environment.