Product Information Website Privacy Policy

Effective as of August 13, 2026.

Orca Biosystems Inc. (“Orca Bio,” “we,” “us” or “our”) develops high-precision cell therapies for the treatment of cancer and autoimmune diseases. This Product Information Website Privacy Policy describes how Orca Bio processes personal information that we collect through our digital or online properties or services that link to this Product Information Website Privacy Policy (including as applicable, our websites and social media pages that link to this Product Information Website Privacy Policy) as well as our marketing and other activities described in this Product Information Website Privacy Policy (collectively, the “Service”). Orca Bio may provide additional or supplemental privacy policies to individuals for specific products or services that we offer at the time we collect personal information.

Orca Bio may process personal information that identifies your past, present or future health status or that otherwise constitutes “consumer health data” or equivalent terms as defined by applicable US state laws (“Consumer Health Data”). To the extent such laws apply to your Consumer Health Data, please see our Consumer Health Data Privacy Policy which supplements this Product Information Website Privacy Policy.

Our personal information practices may vary depending on the nature of the Services you use and our relationship with you. For example, we may collect health-related data about individuals seeking to learn more about our treatments or clinical trials while we generally do not collect such data from general website visitors (or healthcare professionals). Please consider the context in which we interact with you when reading this Product Information Website Privacy Policy.

Index

Personal information we collect

Information you provide to us or that we generate about you. Personal information you may provide to us through the Service or otherwise or that we may generate about you includes:

  • Contact data, such as your first and last name, salutation, email address, mailing address, and phone number.
  • Demographic data, such as your city, state, country of residence, postal code, and age.
  • Profile data, such as the username and password that you may set to establish an online account on the Service, date of birth, invite code, biographical details, health information, photograph or picture, interests, preferences, and any other information that you add to your account profile.
  • Communications data based on our exchanges with you, including when you contact us through the Service, social media, or otherwise.
  • Health-related data, such as your physical or mental health history, conditions and diagnoses, treatments, medications, and other physical or mental health information. You may also provide this data in questionnaires, surveys, requests to share your experiences, interviews, diagnostic results, or other documentary, text, video, or audio interactions related to the provision of our Service.
  • Insurance and benefits-related data, such as your insurance policy number or information about your insurance and benefits history.
  • Professional data, such as name, professional title and employer name, national provider identification number (NPI) or similar, work contact information, signature, CV information, professional licensure information, travel information, picture/video/audio material, and education and professional experience.
  • Marketing data, such as your preferences for receiving our marketing communications and details about your engagement with them.
  • Other data not specifically listed here, which we will use as described in this Product Information Website Privacy Policy or as otherwise disclosed at the time of collection.

Third-party sources. We may combine personal information we receive from you with personal information falling within one of the categories identified above that we obtain from other sources, such as:

  • Public sources, such as government agencies, public records, social media platforms, and other publicly available sources.
  • Private sources, such as data providers (including licensors) and social media platforms.
  • Service providers, that provide services on our behalf or help us operate the Service or our business.
  • Partners, such marketing partners and event co-sponsors.
  • Caregivers, such as family members, health care professionals and medical institutions.
  • Ad networks.
  • Social media platforms.
  • Healthcare provider partners, including third-party healthcare services providers and other providers of medical and medical-adjacent services.
  • Our corporate affiliates.
  • Business transaction partners. We may receive personal information in connection with an actual or prospective business transaction. For example, we may receive your personal information from an entity we acquire or are acquired by, a successor, or assignee or any party involved in a business transaction such as a merger, acquisition, sale of assets, or similar transaction, and/or in the context of an insolvency, bankruptcy, or receivership.

Automatic data collection. We, our service providers, and our business partners may automatically log information about you, your computer or mobile device, and your interaction over time with the Service, our communications and other online services, such as:

  • Device data, such as your computer or mobile device’s operating system type and version, manufacturer and model, browser type, screen resolution, RAM and disk size, CPU usage, device type (e.g., phone, tablet), IP address, unique identifiers, language settings, mobile device carrier, radio/network information (e.g., Wi-Fi, LTE, 3G), and general location information such as city, state or geographic area.
  • Online activity data, such as pages or screens you viewed, how long you spent on a page or screen, the website you visited before browsing to the Service, navigation paths between pages or screens, information about your activity on a page or screen, access times and duration of access, and whether you have opened our emails or clicked links within them.
  • Communication interaction data such as your interactions with our email, text or other communications (e.g., whether you open and/or forward emails) – we may do this through use of pixel tags (which are also known as clear GIFs), which may be embedded invisibly in our emails.

For more information concerning our automatic collection of data, please see the Tracking & other technologies section below.

Data about others. Certain aspects of the Service, such as features for sharing information about your medical conditions or treatment, may allow you to share personal information related to other individuals, such as individuals involved in your treatment. Please do not share another individual’s personal information with us unless you have their permission to do so.

Tracking & other technologies

  • Cookies and other technologies. Some of the automatic collection described above is facilitated by the following technologies:
  • Cookies, which are small text files that websites store on user devices and that allow web servers to record users’ web browsing activities and remember their submissions, preferences, and login status as they navigate a site. Cookies used on our sites include both “session cookies” that are deleted when a session ends, “persistent cookies” that remain longer, “first party” cookies that we place and “third party” cookies that our third-party business partners and service providers place.
  • Local storage technologies, like HTML5, that provide cookie-equivalent functionality but can store larger amounts of data on your device outside of your browser in connection with specific applications.
  • Web beacons, also known as pixel tags or clear GIFs, which are used to demonstrate that a webpage or email was accessed or opened, or that certain content was viewed or clicked. For information concerning your choices with respect to the use of tracking technologies, see the Your choices section below.

How we use your personal information

We may use your personal information for the following purposes or as otherwise described at the time of collection:

Service delivery and operations. We may use your personal information to:

  • provide the Service and operate our business;
  • enable security features of the Service;
  • establish and maintain your user profile on the Service;
  • communicate with you about the Service, including by sending Service-related announcements, updates, security alerts, and support and administrative messages. To the extent we send you SMS/text-based communications, our message frequency varies and message and data rates may apply;
  • to collect and share user testimonials; and
  • provide support for the Service, and respond to your requests, questions and feedback.
  • Service personalization, which may include using your personal information to:
  • understand your needs and interests;
  • personalize your experience with the Service and our Service-related communications; and
  • remember your selections and preferences as you navigate webpages.

    • event, identify, investigate and deter fraudulent, harmful, unauthorized, unethical or illegal activity, including cyberattacks and identity theft

Service improvement and analytics. We may use your personal information to analyze your usage of the Service, improve the Service, improve the rest of our business, help us understand user activity on the Service, including which pages are most and least visited and how visitors move around the Service, as well as user interactions with our emails, and to develop new products and services. For example, we use Google Analytics for this purpose. You can learn more about Google Analytics and how to prevent the use of Google Analytics relating to your use of our sites here: 
https://tools.google.com/dlpage/gaoptout?hl=en.

Marketing and advertising. We, our service providers and our third-party advertising partners may collect and use your personal information for marketing and advertising purposes.

  • Direct marketing. We may send you direct marketing communications and may personalize these messages based on your needs and interests. You may opt-out of our marketing communications as described in the Opt-out of marketing section.
  • Interest-based advertising. We and our third-party advertising partners may use cookies, pixels and other technologies to collect information about your interaction (including the data described in the Automatic Data Collection section above) with the Service, our communications and other third party online services over time, and use that information to serve online ads that they think will interest you. This is called interest-based advertising. We may also share information about our users with these companies to facilitate interest-based advertising to those or similar users on other online properties. You can learn more about your choices for limiting interest-based advertising in the Your choices section.

Compliance and protection. We may use your personal information to:

  • comply with applicable laws, lawful requests, and legal process, such as to respond to subpoenas, investigations or requests from government authorities;
  • protect our, your or others’ rights, privacy, safety or property (including by making and defending legal claims);
  • audit our internal processes for compliance with legal and contractual requirements or our internal policies;
  • enforce the terms and conditions that govern the Service; and
  • prevent, identify, investigate and deter fraudulent, harmful, unauthorized, unethical or illegal activity, including cyberattacks and identity theft.

Cookies and similar technologies. In addition to the other uses included in this section, we may use the Cookies and similar technologies described above for the following purposes:

  • Technical operation. To allow the technical operation of the Service, such as remembering selections as you navigate the site and remembering whether you are logged in.
  • Functionality. To enhance the performance and functionality of our services.
  • Analytics. To help us understand user activity on the Service, including the volume and demographics of users, which pages are most and least visited and how users move around the Service or interact with our emails. For example, we may use Google Analytics for this purpose. You can learn more about Google Analytics and how to prevent the use of Google Analytics relating to your use of our sites here: https://tools.google.com/dlpage/gaoptout.

Data sharing in the context of corporate events, we may share certain personal information in the context of actual or prospective corporate events – for more information, see the How we share your personal information section below.

To create aggregated, de-identified and/or anonymized data. We may create aggregated, de-identified and/or anonymized data from your personal information and other individuals whose personal information we collect. We make personal information into de-identified and/or anonymized data by removing information that makes the data identifiable to you and we will not attempt to reidentify any such data. We may use this aggregated, de-identified and/or anonymized data and share it with third parties for our lawful business purposes, including to analyze and improve the Service and promote our business.

Further uses, in some cases, we may use your personal information for further uses, in which case we will ask for your consent to use of your personal information for those further purposes if they are not compatible with the initial purpose for which information was collected.

How we share your personal information

We may share your personal information with the following parties (or as otherwise described in this Product Information Website Privacy Policy, in other applicable notices, or at the time of collection).

Service providers. Third parties that provide services on our behalf or help us operate the Service or our business (such as hosting, information technology, customer support, email delivery, marketing, consumer research and website analytics).

Third parties designated by you. We may share your personal information with third parties where you have instructed us or provided your consent to do so, for example if you instruct us to share information with your doctor or other healthcare professional.

Partners. Third parties with whom we partner, including parties with whom we co-sponsor events or promotions, with whom we jointly offer products or services, or whose products or services may be of interest to you.

Advertising partners / ad networks. Third-party advertising companies for the interest-based advertising purposes described above.

Social networks. We use their ad services to display ads to our customers, or other people like them, on social media.

Professional advisors. Professional advisors, such as lawyers, auditors, bankers and insurers, where necessary in the course of the professional services that they render to us.

Authorities and others. Law enforcement, government authorities, and private parties, as we believe in good faith to be necessary or appropriate for the Compliance and protection purposes described above.

Business transferees. We may disclose personal information in the context of actual or prospective business transactions (e.g., investments in or financings of Orca Bio, public stock offerings, or the sale, transfer or merger of all or part of our business, assets or shares). For example, we may need to share certain personal information with prospective counterparties and their advisers. We may also disclose your personal information to an acquirer, successor, or assignee of Orca Bio as part of any merger, acquisition, sale of assets, or similar transaction, and/or in the event of an insolvency, bankruptcy, or receivership in which personal information is transferred to one or more third parties as one of our business assets.

Your choices

Access or update your information. If you have registered for an account with us through the Service, you may review and update certain account information by logging into the account.

Opt-out of communications. You may opt out of marketing-related emails by following the opt-out or unsubscribe instructions at the bottom of the email, or by contacting us. Please note that if you choose to opt out of marketing-related emails, you may continue to receive service-related and other non-marketing emails. To the extent you receive SMS/text communications from us, you may opt-out by replying STOP or request more information by replying HELP. If you need assistance of have questions about our SMS service, reply with “HELP” to any SMS message you receive or contact our customer support team at 877-411-ORCA. 

Cookies and other technologies.  Most browsers let you remove or reject cookies. To do this, follow the instructions in your browser settings. Many browsers accept cookies by default until you change your settings. Please note that if you set your browser to disable cookies, the Service may not work properly. For more information about cookies, including how to see what cookies have been set on your browser and how to manage and delete them, visit www.allaboutcookies.org. You can also configure your device to prevent images from loading to prevent web beacons from functioning.

Blocking images/clear gifs: Most browsers and devices allow you to configure your device to prevent images from loading. To do this, follow the instructions in your particular browser or device settings.

Do Not Track. Some Internet browsers may be configured to send “Do Not Track” signals to the online services that you visit. We currently do not respond to “Do Not Track” signals. To find out more about “Do Not Track,” please visit 
http://www.allaboutdnt.com.

Advertising choices. You may be able to limit use of your information for interest-based advertising through the following settings/options/tools:

  • Browser settings. Changing your internet web browser settings to block third-party cookies.
  • Privacy browsers/plug-ins. Using privacy browsers and/or ad-blocking browser plug-ins that let you block tracking technologies.
  • Platform settings. Some platforms offer opt-out features that let you opt-out of use of your information for interest-based advertising. You may be able to exercise that option for Google and Facebook at the following websites:
  • Ad industry tools. Opting out of interest-based ads from companies that participate in the following industry opt-out programs:
  • Mobile settings. Using your mobile device settings to limit use of the advertising ID associated with your mobile device for interest-based advertising purposes.
  • You can learn more and manage your choices at any time by selecting Cookie Settings (powered by OneTrust) or the Your Privacy Rights icon (powered by OneTrust) and reviewing our Cookie Notice, which describes cookies by category, purpose, and provider.

You will need to apply these advertising-related opt-out settings on each device and browser from which you wish to limit the use of your information for interest-based advertising purposes. We cannot offer any assurances as to whether the companies we work with participate in the opt-out programs described above.

Shine the Light law opt out. Under California’s Shine the Light law (California Civil Code Section 1798.83), we give you the right to opt-out of our disclosure of your personal information (as defined by this law) to third parties for their direct marketing purposes. You may send us requests to privacy@orcabio.com. In your request, you must include the statement “Shine the Light Request,” and provide your first and last name and mailing address and certify that you are a California resident. We reserve the right to require additional information to confirm your identity and California residency.

Declining to provide information. We need to collect personal information to provide certain services. If you do not provide the information we identify as required or mandatory, we may not be able to provide those services.

Other sites and services

The Service may contain links to websites, mobile applications, and other online services operated by third parties. In addition, our content may be integrated into web pages or other online services that are not associated with us. These links and integrations are not an endorsement of, or representation that we are affiliated with, any third party. We do not control websites, mobile applications or online services operated by third parties, and we are not responsible for their actions. We encourage you to read the privacy policies of the other websites, mobile applications and online services you use.

Security

We employ technical, organizational and physical safeguards designed to protect the personal information we collect. However, security risk is inherent in all internet and information technologies and we cannot guarantee the security of your personal information.

International data transfers

We are headquartered in the United States and may use service providers that operate in other countries. Your personal information may be transferred to the United States or other locations where privacy laws may not be as protective as those in your state, province, or country. 

Children

The Service is not intended for use by anyone under 18 years of age. If you are a parent or guardian of a child from whom you believe we have collected personal information in a manner prohibited by law, please contact us. If we learn that we have collected personal information through the Service from a child without the consent of the child’s parent or guardian as required by law, we will comply with applicable legal requirements to delete the information.

Changes to this Product Information Website Privacy Policy

We reserve the right to modify this Product Information Website Privacy Policy at any time. If we make material changes to this Product Information Website Privacy Policy, we will notify you by updating the date of this Product Information Website Privacy Policy and posting it on the Service or other appropriate means. Any modifications to this Product Information Website Privacy Policy will be effective upon our posting the modified version (or as otherwise indicated at the time of posting). In all cases, your use of the Service after the effective date of any modified Product Information Website Privacy Policy indicates your acknowledgement that the modified Product Information Website Privacy Policy applies to your interactions with the Service and our business.

How to contact us

If you have questions about our practices or if you would like to exercise any privacy-related right that may be available to you, please contact us via the method listed below.

IMPORTANT SAFETY INFORMATION AND INDICATIONS AND USAGE

ISI tray

ISI tray

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Graft Failure: Graft failure has occurred after TREGZI administration. Screen TREGZI recipients for antidonor antibodies that may prevent engraftment. Monitor patients closely for laboratory evidence of hematopoietic recovery.

Graft-Versus-Host Disease: Acute and chronic Graft-Versus-Host disease (GVHD), including life-threatening and fatal cases, occurred following treatment with TREGZI. Acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GVHD may include skin rash, mouth sores, dry eyes, liver inflammation, and development of scar tissue in the skin and joints and damage to the lungs. Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD, and treat if GVHD develops.

Infusion Reactions: Infusion reactions (IRs) may occur during or following treatment with TREGZI. Serious hypersensitivity reactions including anaphylaxis may occur to DMSO, human serum albumin (HSA), Dextran or murine protein present in TREGZI. IRs may begin within minutes of the start of TREGZI infusion, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of IRs during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Premedicate patients with antipyretics and histamine antagonists prior to infusion to reduce the incidence and intensity of infusion reactions.

Secondary Malignancies and Malignancies of Donor Origin: Secondary malignancies and malignancies of donor origin may occur following treatment with TREGZI. Development of secondary malignancies, including posttransplantation lymphoproliferative disorder (PTLD) may occur many years after transplantation. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. No patient treated with TREGZI has developed PTLD. Monitor for malignancies of donor origin and secondary malignancies. Contact Orca Bio at 1-877-290-6722 if any patient is diagnosed with a secondary malignancy or a malignancy of donor origin.

Transmission of Infectious Agents: Transmission of serious infectious or communicable disease or agents may occur with TREGZI treatment as it is derived from human donor blood and manufactured using animal-derived reagents. Risks of transmission of infectious agents may occur despite screening or testing of donors. Risks of transmission of serious infections include, but are not limited to, human immunodeficiency virus, human T cell lymphotropic virus (HTLV)-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, Trypanosoma cruzi, West Nile virus (WNV), cytomegalovirus, transmissible spongiform encephalopathy agents and vaccinia. Monitor patients for signs and symptoms of infections, perform tests for infectious agents and treat as clinically indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) were mucositis, diarrhea, rash, viral infections, infections – pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections.

The most common Grade 3-4 laboratory abnormalities (≥ 20%) are lymphocyte count decreased, platelet count decreased, leukocyte count decreased, neutrophil count decreased and hemoglobin decreased.

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.

Please see accompanying full Prescribing Information.