Consumer Health Data Privacy Policy

Effective as of August 13, 2026.

This Consumer Health Data Privacy Policy (“Consumer Health Data Privacy Policy”) applies to the extent required by applicable U.S. state laws with respect to consumer health data (“Consumer Health Data”) as applicable laws may define that term. This Consumer Health Data Privacy Policy supplements our general privacy policies. In the event of a conflict between our relevant privacy policy (for example, our Corporate Website Privacy Policy, our Product Information Website Privacy Policy or our Logistics Website Privacy Policy), and this Consumer Health Data Privacy Policy, the Consumer Health Data Privacy Policy applies to the extent that it is consistent with applicable U.S. state law.

This Consumer Health Data Privacy Policy describes how Orca Biosystems Inc. (“Orca Bio,” “we,” “us” or “our”) processes Consumer Health Data that we collect via our websites, associated marketing activities and any other activities described in this Policy (collectively, the “Service”)

Consumer Health Data we collect

Consumer Health Data you may provide to us through the Service or otherwise includes:

  • Health-related data, such as information about your medical conditions, medical history, medications, therapies and other treatments, as well as your efforts to seek healthcare-related services and treatments.
  • Biographical data, such as information about your experience with your medical conditions and treatments.
  • Other personal information that is associated with Consumer Health Data.

Consumer Health Data we collect automatically

When you use our Service, we collect some information through certain technical tracking technologies that may be considered Consumer Health Data. For example:

  • Analytics 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.
  • Technical 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.

Consumer Health Data we may create, infer or generate

We may create, infer or generate Consumer Health Data from other data we collect, including using automated means to generate information about your likely preferences or other characteristics. Inferential data may include your product/service interests and other health-related data.

Sources of Consumer Health Data

We may collect Consumer Health Data directly from you, from your interactions with the Service, from public sources (such as government agencies, public records, and social media platforms), data providers (such as information services and data licensors), partners (such as marketing partners and event co-sponsors), service providers (entities or individuals that provide services on our behalf), and business transaction partners (such as entities in an actual or prospective business transaction).

Sources of Consumer Health Data

We may collect Consumer Health Data directly from you, from your interactions with the Service, from public sources (such as government agencies, public records, and social media platforms), data providers (such as information services and data licensors), partners (such as marketing partners and event co-sponsors), service providers (entities or individuals that provide services on our behalf), and business transaction partners (such as entities in an actual or prospective business transaction).

How we use your Consumer Health Data

We use Consumer Health Data for purposes described in this Consumer Health Data Privacy Policy or as otherwise disclosed to you. For example, we use Consumer Health Data for the following purposes:

Purpose of Use Categories of Consumer Health Data
Service delivery and operations, including to provide, operate, and secure the Service (including to provide and manage patient support programs, safety and quality efforts), and communicate with you regarding the Service. Health history data, biographical data, analytics data, technical data
Service personalization, including 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. Health history data, biographical data, analytics data, technical data
Improvement and analytics, including to improve our Service and business and 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. Health history data, biographical data, analytics data, technical data
Compliance and protection. To comply with applicable laws, lawful requests, and legal process (such as to respond to disclosure orders, as well as demands, investigations or requests made by regulators, governments, courts and law enforcement authorities; to protect our, your or others’ rights, privacy, safety or property (including by making and defending legal claims); to audit our internal processes for compliance with legal and contractual requirements or our internal policies; to enforce the terms of agreements that govern access to the Service; and to prevent, identify, investigate and deter fraudulent, harmful, unauthorised, unethical or illegal activity, including cyberattacks and identity theft. Health history data, biographical data, analytics data, technical data
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. 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. Health history data, biographical data, analytics data, technical data
Corporate events. To facilitate or carry out any corporate events, such as 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 (including providing Consumer Health Data to allow third parties to conduct diligence into – and, where relevant, to continue to operate – all or relevant part(s) of our operations). Health history data, biographical data, analytics data, technical data

How we share your Consumer Health Data

We may “share” (as applicable U.S. state laws define that term) Consumer Health Data with your consent or as we determine necessary to provide the Service to you, or as otherwise permitted or required by law. For more information on how we may otherwise disclose your Consumer Health Data, please view the “How we share your personal information” section of our applicable privacy policy.

For example, we may share your Consumer Health Data with:

Authorities and others. We will access, share, and preserve Consumer Health Data when we believe that doing so is necessary to comply with applicable law or respond to valid legal process, including from law enforcement or other government agencies. We will also share Consumer Health Data if we believe it is necessary to protect our customers and/or the rights or property of ourselves or others.

Business transferees. We may disclose your Consumer Health Data in the context of actual or prospective business transactions involving Orca Bio (e.g., investments, financings, stock offerings, or the sale, transfer or merger of all or part of our or our affiliates’ business, assets or shares). For example, we may need to share certain Consumer Health Data with prospective counterparties and their advisers.

Your Consumer Health Data choices

You may have certain rights to your Consumer Health Data under applicable laws. Any of the rights discussed below may be subject to certain limitations (for example, a monetary charge). 

Withdraw consent. To the extent we rely upon your consent for either our collection or sharing of your Consumer Health Data, you have the right to withdraw such consent from any future collection or sharing.

Access and confirm. You have the right to ask us to confirm whether we have collected, shared or sold your Consumer Health Data. Further, you have the right to access (in other words, request a copy of) the Consumer Health Data that we have collected, shared or sold. You also have a right to access a list of all “third parties” (as applicable U.S. state laws define that term) and affiliates with whom we have shared or sold your Consumer Health Data and receive certain corresponding information.

Correction. You have the right to ask us to correct inaccuracies in your Consumer Health Data.

Deletion. You have the right to ask us to delete your Consumer Health Data.

Appeal. You have the right to appeal our denying a right you have attempted to exercise. We will provide details on how to appeal our denial in connection with such action.
To exercise your rights above and make a Consumer Health Data rights request, please email us at privacy@orcabio.com.  We may need to verify your identity in order to process your request. To confirm your identity, we may ask you to verify personal information we already have on file for you. If we cannot verify your identity based on the information we have on file, we may request additional information from you (such as government identification), which we will only use to verify your identity, and for security or fraud-prevention purposes.

Declining to provide information. We need to collect Consumer Health Data to provide certain services. If you do not provide the information we identify as required or mandatory, or if you request that any required Consumer Health Data be deleted or withdraw your consent for future collection or sharing of any required Consumer Health Data, we may not be able to provide those services.

Changes to this Consumer Health Data Privacy Policy

We reserve the right to modify this Consumer Health Data Privacy Policy at any time. If we make material changes to this Consumer Health Data Privacy Policy, we will notify you by updating the date of this Consumer Health Data Privacy Policy and posting it on the Service or other appropriate means. Any modifications to this Consumer Health Data 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 Consumer Health Data Privacy Policy indicates your acknowledging that the modified Consumer Health Data Privacy Policy applies to your interactions with the Service and our business.

How to contact us

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.