CCEL

The Company, in combination with its global affiliates, currently stores over 250,000 cord blood and cord tissue specimens worldwide for the exclusive benefit of newborn babies and possibly other members of their families.
As discussed further in Note 18, on February 23, 2021, the Company entered into a Patent and Technology License Agreement (the “Duke License Agreement”) with Duke University (“Duke”).
Through the Duke License Agreement, the Company had anticipated, either directly or through its wholly-owned subsidiary, Celle Corp., exploring, testing, and administering treatments to patients for which there are limited U.S.
Food and Drug Administration (“FDA”) approved therapies, including cerebral palsy and autism.
Through the Duke License Agreement, the Company intended to develop three business units, namely: (1) its cord blood bank and other storage services (its historical business); (2) cord blood and cord tissue infusion clinic services initially under the FDA's Expanded Access Program and in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain biologics license application (“BLA”) approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) were approved by the FDA.
As discussed further in Note 18, the Company has received from Duke a notice of termination of the License Agreement as of May 17, 2025.
As of the date hereof, it is unlikely that the Company will be able to expand its business into business units (2) and (3) above through the Duke License Agreement.
Until the Duke dispute is resolved, the Company does not anticipate making further investments in activities related to the Duke License Agreement.
The opening of the Cryo-Cell Institute for Cellular Therapies is also on pause and the Company can make no assurances as to when or if it will be opened.
See, “Risk Factors” and Note 12 and Note 18 for additional information regarding Duke.
Over 60,000 cord blood stem cell transplants have been performed to date.
Today, stem cell transplants are known and accepted treatments for at least 80 diseases, we believe, a number of them life-threatening.
The Company also purchased a 56,000 square-foot facility in Durham, North Carolina (the “New Facility”).
The Company acquired the New Facility to accommodate anticipated operations relating to the Patent and Technology Agreement (the “Duke License Agreement”) with Duke University (“Duke”) as discussed further in Note 18.
In addition, the New Facility provides capacity not only for the Company’s existing and anticipated internal storage needs, but also enables the Company to offer storage services to third-parties.
Competitive Advantages The Company believes that it provides several key advantages over its competitors, including: • The world’s first private cord blood bank, that in combination with its global affiliates, currently stores over 250,000 cord blood and cord tissue specimens worldwide, • our facility's status as a cGMP- and cGTP-compliant private cord blood bank with AABB accreditation and FACT (the Foundation for the Accreditation for Cellular Therapy) accreditation, • a state-of-the-art laboratory processing facility, • utilization of a processing method using superior technology that yields the maximum recovery of healthy stem cells and provides superior red blood depletion over all other methods, • a five-compartment cord blood freezer bag that allows for multiple uses of the baby’s cord blood stem cells, • a safe, secure and monitored storage environment, • since inception, 100% viability rate of the Company’s specimens upon thaw for therapeutic use, • a state-of the-art, insulated collection kit, • 7 day per week processing capability, and • a payment warranty under which the Company agrees to pay $50,000 (effective February 1, 2012 this payment was increased to $75,000 for new clients, effective June 1, 2017 this payment was increased to $100,000 for new clients that choose the premium cord blood processing method, PrepaCyte CB) to its client if the umbilical cord blood product retrieved is used for a stem cell transplant for the donor or an immediate family member and fails to engraft, subject to various restrictions.
The Company collects cord blood units at hospitals in California.
ExtraVault On July 18, 2022, the Company completed the purchase of a 56,000 square foot facility located near the Research Triangle Park in the Regional Commerce Center in Durham, North Carolina.
The Company anticipates this Facility will expand the Company’s cryopreservation and cold storage business by introducing a new service, ExtraVault ( www.extravault.com ).
Information on our website is not incorporated into this Annual Report on Form 10-K and Marketing Marketing Approach It is the Company’s mission to inform expectant parents and their prenatal care providers of the potential medical benefits from preserving stem cells and to provide them with the means and processes for collection and storage of these cells.
New expectant parent referrals are provided by physicians, midwives and childbirth educators, and by client-to-client referrals and repeat clients storing the stem cells of their additional children.
The Company has a national team of field cord blood educators who increase awareness of the benefits of storing cord blood and cord tissue to the Company’s clinical referral sources, including physicians, midwives and hospitals and to expectant parents.
Other promotional activities include internet advertisements and telemarketing activities.
In addition, the Company exhibits at conferences, trade shows and other meetings attended by pregnant women and/or medical professionals.
The Company intends to continue offering cord blood and cord tissue banking services to expectant parents and relying on both online advertising and its national team of field cord blood educators to enroll new clients.
A significant portion of its new enrollments are generated from returning customers and referrals.
Many of the Company’s clients choose to enter into either multiyear storage contracts, which results in deferred revenues that are recognized over the life the storage contracts.
Our public units are listed on the NMDP registry, which is connected to all other major international registries.
NMDP has a contract with the Health Resources & Services Administration (HRSA), part of the Human Health Services Department of the US government, to be the single point of access for bone marrow, peripheral blood and cord blood for transplant centers needing stem cells for transplant.
Additionally, the Company has definitive license agreements to market the Company’s umbilical cord blood stem cell programs in Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama.
At November 30, 2025 and November 30, 2024, the Company was in compliance with these requirements.
License Agreement with Duke University As previously disclosed, the Company entered into a Patent and Technology License Agreement dated effective as of February 23, 2021 (as amended, the "Duke License Agreement") with Duke University (“Duke”), pursuant to which Duke granted to the Company an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, subject to Duke’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes.
As such, after attempts to reach compromise, on October 4, 2024, the Company filed a demand for arbitration (the “Arbitration Demand”) with the American Arbitration Association.
The Arbitration Demand includes five counts against Duke, as follows: Count I – Breach of the Duke License Agreement; Count II – Breach of the Implied Contractual Covenant of Good Faith and Fair Dealing; Count III – Fraudulent Inducement to Enter into the Duke License Agreement; Count IV – Violation of North Carolina’s Unfair Trade Practices Act; and Count V – Unjust Enrichment.
The Company has notified Duke that it believes such damages are in excess of $100 million.
On November 18, 2024, Duke responded to the Arbitration Demand and asserted counterclaims against the Company which Duke amended on March 24, 2025, for breach of the License Agreement and indemnity, seeking unspecified damages and related relief.
A final hearing on the Company’s claims and Duke’s counterclaims is scheduled for April 2026.
In Q4 2024, the Company made the final payment of $187,400 under the Clinical Study and Research Agreement that the Company entered into with Duke dated March 3, 2023 in connection with the Second Amendment to the Duke License Agreement.
As previously disclosed, the Duke License Agreement also imposes certain future royalty payment obligations, an obligation to pay certain legal fees and expenses associated with related patents, and an obligation to pay Duke $2,000,000 two years after the first patient or subject is treated in the first Phase III clinical trial of a licensed product comprising mesenchymal stromal cells for an indication other than Autism Spectrum Disorder, of which there can be no assurances.
As stated above, through the Duke License Agreement, the Company had intended to expand to a triad of core business units to include: (1) its cord blood bank and other storage services; (2) cord blood and cord tissue infusion clinic services initially under the FDA's Expanded Access Program and in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain BLA approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) were approved by the FDA.

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Gone since FY2024

The Company, in combination with its global affiliates, currently stores over 240,000 cord blood and cord tissue specimens worldwide for the exclusive benefit of newborn babies and possibly other members of their families.
As discussed further in Note 12, effective as of February 23, 2021, the Company entered into a Patent and Technology License Agreement (the “Duke License Agreement”) with Duke University (“Duke”).
Through the Duke License Agreement, the Company had anticipated, either directly or through its wholly-owned subsidiary, Celle Corp., exploring, testing, and administering treatments to patients with osteoarthritis and with conditions for which there are limited U.S.
Food and Drug Administration (“FDA”) approved therapies, including cerebral palsy, autism, and multiple sclerosis.
Through the Duke License Agreement, the Company, together with Celle Corp., hoped to develop three business units, namely: (1) its cord blood bank and other storage services (its historical business); (2) cord blood and cord tissue infusion clinic services initially under the FDA's Expanded Access Program in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain biologics license application (“BLA”) approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) were approved by the FDA.
Additionally, to support such business expansion, the Company had anticipated opening and launching its Cryo-Cell Institute for Cellular Therapies, which it initially hoped to open as early as the fourth quarter of fiscal 2021, but no later than the first quarter of fiscal 2022, but more recently reported that it anticipated opening it during the fourth quarter of fiscal 2024.
As of the date hereof, the Company can make no assurances it will be able to expand its business into business units (2) and (3) above.
Until the Duke arbitration claims are resolved, the Company does not anticipate making further investments (other than the completion of a comparability study estimated to cost less than $350,000 in additional capital) in activities related to the Duke License Agreement.
The opening of the Cryo-Cell Institute for Cellular Therapies is also on pause and the Company can make no assurances as to when it will be opened.
During fiscal 2023, the Company recognized that there were indications of impairment of the assets associated with the Duke License Agreement.
Over 50,000 cord blood stem cell transplants have been performed to date.
Today, stem cell transplants are known and accepted treatments for at least 78 diseases, we believe, a number of them life-threatening.
Due to the limited storage capacity of its existing facility in Oldsmar, FL, the Company purchased a 56,000 square foot facility located near the Research Triangle Park in the Regional Commerce Center in Durham, North Carolina ("New Facility").
The Company now has space for not only its existing and future internal storage needs, but also has the capacity to offer third party pharmaceutical companies and medical institutions storage services, to set up a cellular therapy laboratory to manufacture mesenchymal stromal cells ("MSCs") and the Cryo-Cell Institute for Cellular Therapies under the same roof.
Competitive Advantages The Company believes that it provides several key advantages over its competitors, including: • The world’s first private cord blood bank, that in combination with its global affiliates, currently stores over 240,000 cord blood and cord tissue specimens worldwide, • our facility's status as a cGMP- and cGTP-compliant private cord blood bank with AABB accreditation and FACT (the Foundation for the Accreditation for Cellular Therapy) accreditation, • a state-of-the-art laboratory processing facility, • utilization of a processing method using superior technology that yields the maximum recovery of healthy stem cells and provides superior red blood depletion over all other methods, • a five-compartment cord blood freezer bag that allows for multiple uses of the baby’s cord blood stem cells, • a safe, secure and monitored storage environment, • since inception, 100% viability rate of the Company’s specimens upon thaw for therapeutic use, • a state-of the-art, insulated collection kits, • 7 day per week processing capability, and • a payment warranty under which the Company agrees to pay $50,000 (effective February 1, 2012 this payment was increased to $75,000 for new clients, effective June 1, 2017 this payment was increased to $100,000 for new clients that choose the premium cord blood processing method, PrepaCyte CB) to its client if the umbilical cord blood product retrieved is used for a stem cell transplant for the donor or an immediate family member and fails to engraft, subject to various restrictions.
The Company collects cord blood units at hospitals in Florida, Arizona, and California.
ExtraVault On July 18, 2022, the Company completed the purchase of a 56,000 square foot facility located near the Research Triangle Park in the Regional Commerce Center in Durham, North Carolina (the “New Facility”).
The Company anticipates this New Facility will expand the Company’s cryopreservation and cold storage business by introducing a new service, ExtraVault ( www.extravault.com ).
On May 15, 2024, the Company received the Certificate of Occupancy for the facility in Durham, North Carolina.
Marketing Marketing Approach It is the Company’s mission to inform expectant parents and their prenatal care providers of the potential medical benefits from preserving stem cells and to provide them the means and processes for collection and storage of these cells.
New expectant parent referrals during fiscal 2024 were provided by physicians, midwives and childbirth educators, and by client-to-client referrals and repeat clients storing the stem cells of their additional children.
The Company has a national sales force to increase its marketing activities with its clinical referral sources, including physicians, midwives and hospitals.
Promotional activities also include advertisements in clinical journals and telemarketing activities.
In addition, the Company exhibits at conferences, trade shows and other meetings attended by medical professionals.
At November 30, 2024 and November 30, 2023, the Company was in compliance with these requirements.
License Agreement with Duke University As previously disclosed, the Company entered into a Patent and Technology License Agreement dated effective as of February 23, 2021 with Duke University (“Duke”), for exclusive commercial rights to novel infusion treatments for patients with serious neurological conditions (as amended, the “Duke License Agreement”).
Specifically, pursuant to the Duke License Agreement, Duke granted to the Company an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, subject to Duke’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes.
Through the Duke License Agreement, the Company intended to develop three business units, namely: (1) its cord blood bank and other storage services (its historical business); (2) cord blood and cord tissue infusion clinic services in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain biologics license application (“BLA”) approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) were approved by the FDA.
As such, after attempts to reach compromise, on October 4, 2024, the Company filed a demand for arbitration (the “Arbitration Demand”) with the American Arbitration Association (“AAA”).
The Arbitration Demand includes five counts against Duke, as follows: Count I – Breach of the Duke License Agreement; Count II – Breach of Implied Contractual Covenant of Good Faith and Fair Dealing; Count III – Fraudulent Inducement to Enter into Duke License Agreement; Count IV – Violation of North Carolina’s Unfair Trade Practices Act; and Count V – Unjust Enrichment.
In connection therewith, the Company has requested that the arbitrator enter an award in the Company’s favor and against Duke for damages in an amount to be proved at a final hearing, interest, attorneys’ fees, and arbitration fees and costs, along with all other relief to which the Company is entitled at law or in equity.
Cryo-Cell has notified Duke that it believes such damages are in excess of $100 million.
The Company has made the required payments due to Duke to date under the Duke License Agreement, and in Q4 2024 made the final payment of $187,400 under the Clinical Study and Research Agreement that the Company entered into with Duke dated March 3, 2023 in connection with the Second Amendment to the Duke License Agreement.
As previously disclosed, the Duke License Agreement also imposes certain future royalty payment obligations along with an obligation to pay certain legal fees and expenses associated with related patents.
The Company is also obligated to pay Duke $2,000,000 two years after the first patient or subject is treated in the first Phase III clinical trial of a licensed product comprising mesenchymal stromal cells for an indication other than Autism Spectrum Disorder, of which there can be no assurances.
As of the twelve months ended November 30, 2024 and November 30, 2023, the Company recorded $0 and $960,774, respectively, in amortization expense which is reflected in amortization expense on the accompanying consolidated statements of income.
As stated above, through the Duke License Agreement, the Company had intended to expand to a triad of core business units to include: (1) its cord blood bank and other storage services; (2) cord blood and cord tissue infusion clinic services in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain BLA approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) were approved by the FDA.
The Company’s previously disclosed agreement with a clinical research organization, The Emmes Company, LLC, will require an immaterial final payment if the Company terminates such agreement.
See “Risk Factors.” Subsidiaries and Joint Ventures Since its inception, Cryo-Cell has entered into a number of business activities through subsidiaries and joint ventures, including the following activities and those described under “International” below.
The Company made total payments to all RSA holders of $1,058,311 and $1,009,813 for the fiscal years ended November 30, 2024 and November 30, 2023 respectively, exclusive of termination and repurchase payments.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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