Cryo-Cell International(CCEL)

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Cryo-Cell International(CCEL) - 2025 Q1 - Quarterly Report
2025-04-14 21:00
Cord Blood and Tissue Services - The company currently stores over 240,000 cord blood and cord tissue specimens, having been the first private cord blood bank to separate and store stem cells in 1992[136]. - The company introduced its cord tissue service in 2011, which stores a section of the umbilical cord tissue, expanding its service offerings[137]. - The company has a 100% viability rate of its specimens upon thaw for therapeutic use since inception[151]. - The company charges an annual fee for storage after the first year, with options for 18-year and lifetime pre-paid storage plans[149]. - The company offers a payment warranty of up to $100,000 for clients if the umbilical cord blood product fails to engraft for a stem cell transplant[151]. Financial Performance - Revenue for the three months ended February 28, 2025 was $7,968,880, an increase of 2% compared to $7,852,235 for the same period in 2024[164]. - Processing and storage fees for the three months ended February 28, 2025 were $7,865,888, reflecting a 4% increase in recurring annual storage fee revenue, despite a 12% decrease in new domestic cord blood specimens processed[165]. - Product revenue for the three months ended February 28, 2025 was $20,913, significantly up from $3,000 in the same period in 2024[166]. - Cost of sales decreased by 4% to $1,984,588 for the three months ended February 28, 2025, compared to $2,066,371 for the same period in 2024[167]. - Selling, general and administrative expenses increased by 5% to $4,638,285 for the three months ended February 28, 2025, compared to $4,428,566 in 2024[168]. - Research, development, and related engineering expenses dropped to $98,143 for the three months ended February 28, 2025, down from $502,889 in the same period in 2024[169]. - Interest expense increased to $494,962 for the three months ended February 28, 2025, compared to $256,459 in the same period in 2024[171]. - Cash and cash equivalents decreased to $223,122 as of February 28, 2025, down from $560,960 at November 30, 2024[178]. Duke License Agreement Dispute - The company recorded an impairment charge of $13,108,064 during the fourth quarter of fiscal 2023 related to the Duke License Agreement[141]. - The Company anticipates needing over $50 million over the next 5 years to fund activities related to the Duke License Agreement[180]. - The Company has filed an Arbitration Demand against Duke, alleging damages exceeding $100 million due to fraudulent inducement and breaches of the License Agreement[181]. - Duke has responded with counterclaims for breach of the License Agreement, seeking unspecified damages[182]. - The Company is unable to predict funding needs related to the Duke License Agreement until the dispute is resolved, pausing investments except for a comparability study costing less than $350,000[183]. - Previously, the Company estimated needing over $50 million over the next 5 years for activities related to the Duke License Agreement, but this is now uncertain due to the ongoing arbitration[184]. - If required to continue investing in the Duke License Agreement, the Company plans to use cash-on-hand, future cash flows, a revolving line of credit, and potential debt or equity financing[184]. Research and Development - The company has expanded its research and development activities to include technologies related to stem cells harvested from sources beyond umbilical cord blood[137]. - The company believes that the market for cord blood stem cell preservation is enhanced by global discussions on stem cell research and the focus on reducing healthcare costs[148]. - The company anticipates opening the Cryo-Cell Institute for Cellular Therapies in the fourth quarter of fiscal 2024, although this is currently on hold due to the Duke dispute[139][140]. Market Competition - The company has faced challenges with competition from public cord blood banks, particularly in overseas markets[134].
Cryo-Cell International(CCEL) - 2024 Q4 - Annual Report
2025-02-28 22:00
Financial Performance - For the fiscal year ended November 30, 2024, the Company reported revenue of $31,986,106, a 2% increase from $31,343,695 in the previous year[174]. - Processing and storage fees increased to $31,551,550, reflecting a 4% rise in recurring annual storage fee revenue, despite a 6% decrease in new domestic cord blood specimens processed[175]. - Revenue from public cord blood banking decreased to $366,672, down from $481,148 in the previous year[177]. - Interest expense for the fiscal year ended November 30, 2024, was $1,864,684, an increase from $1,236,794 in fiscal 2023[187]. - U.S. income tax expense for the twelve months ended November 30, 2024, was $2,402,026 compared to an income tax benefit of $3,842,826 for the twelve months ended November 30, 2023[189]. - Net cash provided by operating activities in fiscal 2024 was $6,010,910, down from $8,919,754 in fiscal 2023[198]. - The Company recorded a gain of $105,887 on the change in the fair value of a derivative for the fiscal year ended November 30, 2024[188]. Expenses - Cost of sales decreased by 5% to $7,947,752, attributed to reduced processing of new domestic cord blood specimens[178]. - Selling, general and administrative expenses rose by 8% to $18,521,218, primarily due to increased selling and marketing expenses and personnel costs[179]. - Research, development, and related engineering expenses increased to $1,242,536, with $324,435 allocated to the Clinical Study and Research Agreement with Duke University[180]. Impairment and Legal Matters - The Company recorded an impairment charge of $13,108,064 for the Duke License Agreement in the fourth quarter of fiscal 2023[171]. - The Company filed a demand for arbitration against Duke, alleging damages exceeding $100 million[197]. - As of November 30, 2024, the Company had approximately 6,000 cord blood units in inventory, with an impairment charge of $3,737,133 recognized during the fourth quarter of 2023[220]. Business Operations and Future Plans - The Company plans to expand its business into biopharmaceutical manufacturing and operating clinics, contingent on the resolution of the Duke Dispute[169]. - The proposed spinoff of Celle Corp. is currently on hold pending the outcome of the Duke Dispute[170]. - The Company has stored over 240,000 cord blood and cord tissue specimens, maintaining its position as a leading private cord blood bank since its founding in 1989[167]. Cash Flow and Financing - Net cash used in investing activities in fiscal 2024 was $4,876,899, primarily due to $2,403,708 for equipment purchases and $1,200,000 related to the Duke License Agreement[198]. - The Company had cash and cash equivalents of $560,960 as of November 30, 2024, compared to $406,067 at November 30, 2023[194]. - The balance of the revolving line of credit as of November 30, 2024, was $3,520,000[195]. - The Company anticipates needing over $50 million over the next 5 years for activities related to the Duke License Agreement, but current funding needs are uncertain due to ongoing arbitration[196][200]. Stock and Compensation - The Company has three stock-based employee compensation plans, with expenses recognized based on fair value and vesting conditions[210]. - The Company has adopted the 2022 Equity Incentive Plan, reserving 1,500,000 shares for stock options and other stock awards[215]. Licensing and Revenue Sharing - The Company has entered into licensing agreements in various international markets, including one agreement each in El Salvador, Guatemala, Panama, Honduras, and Pakistan, and two agreements in India, Nicaragua, and Costa Rica[216]. - The Company earns royalties on processing and storage fees from licensees, which are included in processing and storage fees revenue[218]. - The Company recognizes non-refundable fees from Revenue Sharing Agreements as a long-term liability, with cash flows fluctuating from period to period[222]. - Accounts receivable are due within 30 days and are stated net of an allowance for doubtful accounts, which may increase if clients' financial conditions deteriorate[219]. Contingent Consideration - The estimated fair value of contingent consideration from the sale of public cord blood inventory is determined using a Monte Carlo analysis[224]. - The Company did not note any impairment for long-lived assets for the twelve months ended November 30, 2024, and November 30, 2023[208]. - The Company capitalized $409,307 and $683,524 of interest related to the construction of its new facility in North Carolina during fiscal 2024 and 2023, respectively[187].
Cryo-Cell International(CCEL) - 2024 Q3 - Quarterly Results
2024-10-16 21:54
Financial Results Announcement - The company announced its financial results for the three and nine months ended August 31, 2024[2] - A press release detailing the financial results was issued on October 15, 2024[2] Financial Statements - The financial statements of businesses acquired are not applicable[4] Company Classification - The company is not classified as an emerging growth company[2] Report Features - The report includes a cover page interactive data file[4]
Cryo-Cell International(CCEL) - 2024 Q3 - Quarterly Report
2024-10-15 21:18
Financial Performance - Revenue for the nine months ended August 31, 2024 was $23,961,761, a 2.1% increase from $23,466,980 in the same period in 2023[138]. - Processing and storage fee revenue increased by 3%, while there was a 4% decrease in the number of new domestic cord blood specimens processed[139]. - Public cord blood banking revenue for the nine months ended August 31, 2024 was $205,799, down from $398,896 in the same period in 2023, reflecting customer demand volatility[139]. - Revenue for the three months ended August 31, 2024 was $8,066,715, a 3% increase from $7,869,875 in the same period in 2023[147]. - Public cord blood banking revenue for the three months ended August 31, 2024 was $120,609, significantly up from $4,383 in the same period in 2023, indicating a recovery in customer demand[148]. Expenses and Financial Metrics - Selling, general and administrative expenses increased by 7% to $12,510,787 for the nine months ended August 31, 2024, compared to $11,722,435 in 2023[141]. - Research and development expenses rose to $937,907 for the nine months ended August 31, 2024, up from $727,648 in 2023, with significant funding for clinical studies[141]. - Selling, general and administrative expenses for the three months ended August 31, 2024, increased by 9% to $4,149,785 compared to $3,804,564 in the same period of 2023[150]. - Research, development, and related engineering expenses decreased to $193,933 for the three months ended August 31, 2024, down from $344,132 in 2023[150]. - Interest expense decreased to $1,119,196 for the nine months ended August 31, 2024, down from $1,405,825 in the same period in 2023[145]. - Interest expense rose to $533,464 for the three months ended August 31, 2024, compared to $469,642 in the same period of 2023[153]. - Gains on marketable securities significantly increased to $522,458 for the three months ended August 31, 2024, from $93,386 in 2023[153]. - Cash and cash equivalents decreased to $197,437 as of August 31, 2024, down from $406,067 at November 30, 2023[159]. - Net cash from operating activities for the nine months ended August 31, 2024, was $3,853,917, compared to $5,575,440 in the same period of 2023[159]. - The balance of the revolving line of credit as of August 31, 2024, was $2,222,728[160]. Legal and Regulatory Matters - During fiscal 2023, the company recorded an impairment charge of $13,108,064 related to the Duke License Agreement[117]. - The company has paused investments related to the Duke License Agreement until arbitration claims are resolved, with only a comparability study costing less than $350,000 planned[117]. - The proposed spinoff of Celle Corp. is on hold and may not occur depending on the outcome of the Duke dispute[117]. - The company filed a demand for arbitration against Duke, alleging damages exceeding $100 million[162]. - The company does not anticipate making further investments in activities related to the Duke License Agreement until arbitration claims are resolved[163]. - The company anticipates needing over $50 million over the next 5 years for activities related to the Duke License Agreement, but current arbitration claims may affect this[161][165]. Business Operations and Strategy - The company currently stores over 235,000 cord blood and cord tissue specimens for newborns and their families[115]. - The anticipated opening of the Cryo-Cell Institute for Cellular Therapies has been postponed to the fourth quarter of fiscal 2024[116]. - The company aims to maximize growth potential through superior quality, value-driven competitive leadership, and increased public awareness[123]. - The company believes that the market for cord blood stem cell preservation is enhanced by global discussions on stem cell research and reducing healthcare costs[124]. - The company operates from a nearly 18,000 square-foot cGMP/cGTP-compliant facility designed for security and operational redundancies[126]. - The company has expanded its R&D activities to develop technologies related to stem cells harvested from sources beyond umbilical cord blood[115]. - The Company completed the purchase of a 56,000 square foot facility in Durham, North Carolina, to expand its cryopreservation and cold storage business[130]. - The new facility is expected to introduce the ExtraVault service, providing cold storage solutions to biopharmaceutical companies and healthcare institutions[131].
Cryo-Cell International(CCEL) - 2024 Q2 - Quarterly Report
2024-07-15 21:00
SIGNATURES 54 2 CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS The accompanying notes are an integral part of these consolidated financial statements. | --- | --- | --- | --- | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------------------------|-------------------| | | | (Unaudited) May 31, 2024 | November 30, 2023 | | ASSETS | ...
Cryo-Cell International(CCEL) - 2024 Q1 - Quarterly Report
2024-04-15 21:10
Corporate Structure and Subsidiaries - The Company formed a wholly owned subsidiary, Celle Corp., on February 22, 2024, to hold certain assets not directly associated with its recurring revenue stream [71]. Financial Projections and Needs - The Company anticipates needing over $50 million over the next 5 years to fund various activities, including clinical trials and capital expenditures [75]. - The Company anticipates discretionary capital expenditures of approximately $5,000,000 over the next twelve months for property build-out and equipment purchases [223]. - The Company anticipates that its cash and cash equivalents, marketable securities, and cash flows from future operations will be sufficient to fund its known cash needs for at least the next 12 months [243]. Legal and Compliance Matters - The Company believes that the resolution of a legal matter will not have a material adverse effect on its business or financial position, although there is a possibility of an unfavorable outcome [67]. - The Company’s common stock may be delisted from NYSE if it fails to comply with continued listing standards, which could adversely affect liquidity and capital raising efforts [72]. Financial Reporting and Internal Controls - The Company’s internal controls over financial reporting were deemed not effective due to a material weakness in identifying appropriate accounting treatment for non-routine transactions [60]. - The Company adopted ASU 2016-13 regarding credit losses as of December 1, 2023, with no material impact on its consolidated financial statements [89]. Revenue and Income - The company reported a net income of $556,241 for the three months ended February 29, 2024, compared to $766,812 for the same period in 2023, reflecting a decrease of approximately 27.4% [109]. - Total net revenue for the three months ended February 29, 2024, was $7,852,235, compared to $7,824,415 for the same period in 2023, reflecting a slight increase [133]. - Revenue from public cord blood banking sales for the three months ended February 29, 2024, was $43,713, a decrease from $230,697 for the same period in 2023, representing a decline of approximately 81% [196]. Expenses and Costs - The total cost of sales for the three months ended February 29, 2024, was $2,160,468, compared to $2,067,364 for the same period in 2023, indicating an increase of approximately 4.5% [133]. - Selling, general, and administrative expenses for the three months ended February 29, 2024, were $4,339,645, representing a 12% increase from $3,878,903 in 2023 [234]. - Interest expense for the three months ended February 29, 2024, was $256,459, down from $466,231 in the comparable period in 2023 [236]. Assets and Inventory - Total inventory as of February 29, 2024, was $5,979,140, a slight decrease from $6,028,996 as of November 30, 2023 [104]. - The Company had approximately 6,000 cord blood units in inventory as of February 29, 2024, valued at the lower of cost or net realizable value [251]. Clinical Trials and Research - The total cost of the phase 3 clinical trial for treating children with cerebral palsy is estimated at $20 million, with clinical trial expenses recorded as $94,099 for the three months ended February 29, 2024 [161]. - The company has completed or is in progress of 19 FDA approved clinical trials related to the Duke License Agreement and intends to fund additional trials as necessary [155]. Strategic Plans and Business Development - The company aims to expand its core business units to include cord blood storage services, infusion clinic services, and biopharmaceutical manufacturing if BLA(s) are approved by the FDA [174]. - The company plans to open the Cryo-Cell Institute for Cellular Therapies in a 56,000 square feet facility in Durham, with operations expected to begin during fiscal 2024 [169][174]. - The company intends to expand its cryopreservation and cold storage business with the introduction of a new service, ExtraVault, aimed at biopharmaceutical companies and healthcare institutions [192]. Market Position and Competitive Advantage - The company has a competitive advantage as the world's first private cord blood bank, currently storing over 500,000 cord blood and cord tissue specimens [189]. - The company has a national team of field cord blood educators to increase awareness of the benefits of storing cord blood and cord tissue [193]. Cash Flow and Financing Activities - Net cash used in operating activities for the three months ended February 29, 2024, was $356,865, compared to net cash provided of $1,643,926 for the same period in 2023 [241]. - Net cash provided by financing activities for the three months ended February 29, 2024, was $538,959, mainly from a $950,000 line of credit, offset by $240,665 in repayments and $170,376 for stock repurchases [241]. Impairment and Asset Management - The company recorded an impairment charge of $13,108,064 during the fourth quarter of fiscal 2023 due to uncertain future cash flows from the Duke license agreement [160]. - The company has recognized indications of impairment of assets associated with the Duke license agreement, leading to a full impairment of the asset [160].
Cryo-Cell Reports Financial Results for Fiscal Year Ended November 30, 2023
Businesswire· 2024-02-28 22:00
OLDSMAR, Fla.--(BUSINESS WIRE)--Cryo-Cell International, Inc. (NYSE American LLC: CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for its fiscal year ended November 30, 2023. Financial Results Revenue Consolidated revenues for fiscal 2023 were $31.3 million compared to $30.3 million for fiscal 2022. The revenues for fiscal 2023 consisted of $30.8 million in processing and storage fee revenue, $66,000 in product revenue and $481, ...
Cryo-Cell International(CCEL) - 2023 Q4 - Annual Report
2024-02-27 16:00
Facility and Service Expansion - The company completed the purchase of a 56,000 square foot facility in Durham, North Carolina, to support internal storage needs and offer cold storage services to third-party pharmaceutical companies [26]. - The company introduced an advanced new cord tissue service in August 2011, which stores a section of umbilical cord tissue, enhancing its service offerings [24]. - The company has expanded its research and development activities to include technologies related to stem cells harvested from sources beyond umbilical cord blood [18]. - The Company acquired substantially all assets of Cord:Use, enhancing its public cord blood inventory, which is stored in North Carolina and distributed globally through the National Marrow Donor Program [43]. Marketing and Sales - The company has a national sales force to increase marketing activities with clinical referral sources, including physicians, midwives, and hospitals [29]. - During fiscal 2023, new expectant parent referrals were driven by physicians, midwives, and client-to-client referrals, indicating high customer satisfaction [46]. - The Company continues to promote its services through internet marketing and updates its website to provide resources for expectant parents [47][48]. Financial Performance - Total revenue for the year ended November 30, 2023, was $31,343,695, an increase of 3.3% from $30,336,749 in 2022 [426]. - Processing and storage fees contributed $30,796,091 to total revenue, up from $29,771,123, reflecting a growth of 3.4% [426]. - The company reported a net loss of $9,521,669 for the year, compared to a net income of $2,771,408 in the previous year, indicating a significant decline [426]. - Total current assets decreased to $9,452,837 from $9,610,185, a reduction of 1.6% [424]. - Total liabilities increased to $72,252,002, up from $66,412,356, representing an increase of 8.3% [424]. - Cash and cash equivalents decreased significantly to $406,067 from $1,703,958, a decline of 76.1% [424]. - The company incurred $17,115,514 in selling, general and administrative expenses, an increase of 9.9% from $15,580,274 [426]. - Total stockholders' deficit increased to $31,159,182 as of November 30, 2023, compared to $21,637,513 in the previous year [457]. Impairment and Charges - An impairment charge of $13,108,064 was recorded due to the results of a phase 2/3 trial showing no benefit from mesenchymal stem cell preparations compared to standard care [419]. - The company incurred an impairment of $13,108,064 related to the Duke License Agreement asset [455]. - The Company recognized an impairment of $377,810 related to patents associated with the Duke assets for the twelve months ended November 30, 2023, compared to no impairment in the previous year [559]. Deferred Revenue and Liabilities - As of November 30, 2023, the total deferred revenue amounted to $50,891,353, with $9,704,553 expected to be recognized over the next twelve months [470]. - The company’s contract liabilities (deferred revenue) increased from $45,586,386 to $50,891,353 during the twelve months ended November 30, 2023 [482]. - The minimum annual royalties payable to Duke have been amended, with Year 3 set at $500,000 and Year 4 at $1,000,000 [59]. Accreditations and Compliance - The company holds AABB and FACT accreditations, positioning it as a quality leader in the private cord blood banking industry [49]. - The company is required to register with the FDA and is subject to FDA inspection due to its ongoing cellular storage business [33]. - The company is currently registered or licensed to operate in states with specific requirements, including California, Illinois, Maryland, New Jersey, and New York [53]. Inventory and Assets - The company has approximately 6,000 cord blood units in inventory valued at the lower of cost or net realizable value as of November 30, 2023 [507]. - Total inventory as of November 30, 2023, was $6,028,996, down from $10,126,574 as of November 30, 2022, representing a decrease of approximately 40.5% [557]. - The Company’s work-in-process inventory increased to $341,692 as of November 30, 2023, from $254,953 in the previous year, reflecting a growth of approximately 34% [557]. - Finished goods inventory decreased to $48,045 as of November 30, 2023, from $62,554 in the previous year, a decline of about 23.3% [557]. Stock and Compensation - The company recognized a compensatory element of stock options amounting to $816,639 during the year [457]. - The Company’s stock-based compensation expense is recognized over the requisite service period, with estimates based on fair value at the grant date [551]. - Performance-based equity awards are contingent on achieving specific financial performance goals, with adjustments made based on the probability of meeting these targets [553]. Research and Development - Research, development, and related engineering costs are expensed as incurred, with no specific figures provided in the documents [543]. - The Company does not intend to enter into additional Revenue Sharing Agreements (RSAs) as reflected in the financial statements [528].
Cryo-Cell International(CCEL) - 2023 Q3 - Quarterly Report
2023-10-11 16:00
Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 par value CCEL NYSE American LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☑ Smaller reporting company ☑ Emerging growth company ☐ FORM 10-Q U.S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 Check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the regis ...
Cryo-Cell International(CCEL) - 2023 Q2 - Quarterly Report
2023-07-13 16:00
Business Operations - The company currently stores over 225,000 cord blood and cord tissue specimens for newborns and their families [183]. - The company has expanded its research and development to include technologies related to stem cells harvested from sources beyond umbilical cord blood [171]. - The company entered into a Patent and Technology License Agreement with Duke University, granting exclusive commercial rights to proprietary processes related to cord blood and cord tissue [195]. - The company acquired substantially all assets of Cord:Use, enhancing its public cord blood inventory [191]. - The company has introduced a new cord tissue service, which stores a section of the umbilical cord tissue, enhancing its service offerings [190]. - The company is focused on expanding its core business units to include biopharmaceutical manufacturing if BLA(s) are approved by the FDA [178]. - The company believes that the market for cord blood stem cell preservation is enhanced by global discussions on stem cell research and reducing healthcare costs [187]. - The company has entered into a License and Royalty Agreement with LifeCell to market its umbilical cord blood and menstrual stem cell programs in India [139]. - The Company has definitive license agreements to market umbilical cord blood stem cell programs in six Central American countries [154]. Financial Performance - Total revenue for the three months ended May 31, 2023, was $7,772,690, a 1.8% increase from $7,633,217 for the same period in 2022 [6]. - Processing and storage fees contributed $7,581,697 to total revenue, compared to $7,480,082 in the prior year, reflecting a growth of 1.4% [6]. - Net income for the three months ended May 31, 2023, was $220,976, a decrease of 65.2% from $634,719 in the same period last year [6]. - Total net revenue for the company reached $15,597,105, an increase from $14,891,748 in the previous year, representing a growth of approximately 4.7% [91]. - The cost of sales totaled $4,210,550, down from $4,304,742, indicating a decrease of about 2.2% [91]. - Operating profit increased to $2,711,069 from $2,664,796, reflecting a growth of approximately 1.7% [91]. - The company reported a total inventory of $9,715,581 as of May 31, 2023, down from $10,126,574 as of November 30, 2022, a decrease of about 4.1% [94]. - The company recorded a provision for doubtful accounts of $403,040 for the six months ended May 31, 2023, compared to $399,953 for the same period in 2022 [27]. - The company incurred a loss of $223,974 on a derivative related to interest rate swaps as of May 31, 2023 [87]. Assets and Liabilities - Current assets increased to $10,313,477 as of May 31, 2023, compared to $9,610,185 as of November 30, 2022, representing a growth of 7.3% [5]. - Total liabilities rose to $69,616,083 as of May 31, 2023, up from $66,412,356 as of November 30, 2022, indicating a 3.3% increase [5]. - The accounts receivable balance as of May 31, 2023, was $6,682,479, an increase from $6,043,941 as of November 30, 2022 [41]. - The company’s total stockholders' equity as of May 31, 2022, was $4,406,983, reflecting a decrease from previous periods [29]. - The total lease liability as of May 31, 2023, was $1,191,845, significantly higher than $610,989 as of November 30, 2022, representing an increase of approximately 95.3% [144]. Research and Development - The company projects to open the Cryo-Cell Institute for Cellular Therapies and begin infusing patients during fiscal 2024 due to equipment delivery delays [172]. - Research, development, and related engineering expenses increased significantly to $304,682 for the three months ended May 31, 2023, compared to $80,896 in the same period last year, marking a growth of 276.5% [6]. - Duke has completed or is in progress with a total of 19 FDA approved clinical trials related to the Duke License Agreement [162]. - The readout from a Phase 3 clinical trial run by Emory University, which compares Duke's MSCs to the current standard of care for osteoarthritis, is expected in 2023 [163]. Stock and Compensation - The company has three stock-based compensation plans, with the 2022 Plan effective from April 8, 2022 [51]. - The company recognized approximately $470,000 and $149,000 in stock compensation expense for the six months ended May 31, 2023 and 2022, respectively [51]. - The fair value of options granted during the six months ended May 31, 2023 was $2.19, compared to $4.56 for the same period in 2022, indicating a decrease of approximately 52.0% [133]. - As of May 31, 2023, there were 198,578 service-based options issued under the 2012 Equity Incentive Plan, with no shares available for future issuance under this plan [128]. - The Company has approximately $292,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements, expected to be recognized over a weighted-average period of 1.85 years [137]. Warranty and Legal Matters - The company offers a payment warranty of up to $100,000 for clients using its premium cord blood processing method if the product fails to engraft [190]. - The company has not experienced any claims under its payment warranty program, which has increased from $50,000 to $100,000 for new clients since 2017 [89]. - The Company believes that the ongoing litigation regarding umbilical cord blood storage services will not have a material adverse effect on its business, although there is a possibility of an unfavorable outcome [123].