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What changed in Century Therapeutics, Inc.'s 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of Century Therapeutics, Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+650 added−603 removedSource: 10-K (2024-03-14) vs 10-K (2023-03-16)

Top changes in Century Therapeutics, Inc.'s 2023 10-K

650 paragraphs added · 603 removed · 477 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

221 edited+89 added−24 removed429 unchanged
Biggest changeWe have created a comprehensive allogeneic cell therapy platform that includes industry-leading induced pluripotent stem cells, or iPSCs, differentiation know-how to generate immune effector cells from iPSCs, or iPSC- derived cells, clustered regularly interspaced short palindromic repeats, or CRISPR, mediated precision gene editing that allows us to incorporate multiple transgenes and remove target genes intended to optimize cell product performance, sophisticated protein engineering capabilities to develop proprietary next generation chimeric antigen receptors, or CARs, our proprietary Allo-Evasion TM technology intended to prevent rejection of our cell products by the host immune system, and cutting edge manufacturing capabilities intended to minimize product development and supply risk.
Biggest changeWe have created a comprehensive, genetically engineered allogeneic cell therapy platform that includes: ​ • Industry-leading induced pluripotent stem cells, or iPSCs, and differentiated know-how to generate immune effector cells from iPSCs, or iPSC- derived cells; ​ • Clustered regularly interspaced short palindromic repeats, or CRISPR, mediated precision gene editing that allows us to incorporate multiple transgenes and remove target genes intended to optimize cell product performance; ​ • Sophisticated protein engineering capabilities to develop proprietary next generation chimeric antigen receptors, or CARs; ​ • Our proprietary Allo-Evasion TM technology intended to prevent rejection of our cell products by the host immune system; and ​ • Cutting edge manufacturing capabilities intended to minimize product development risk and supply risk as well as maximize the opportunity provided by our platform to drive down cost of goods and increase patient access. ​ We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies.
We believe that these vertically integrated capabilities will allow us to further expand our existing pipeline and develop therapeutics from iPSC-derived natural killer cells, or iNK cells, or iNK, and iPSC-derived T cells, or iT cells, or iT, that may provide enhanced clinical outcomes compared to available therapeutic options.
We believe these vertically integrated capabilities will allow us to further expand our existing pipeline and develop therapeutics from iPSC-derived natural killer cells, or iNK cells, or iNK, and iPSC-derived T cells, or iT cells, or iT, that may provide enhanced clinical outcomes compared to available therapeutic options.
This multi-product, multi-phase facility will has the capabilities and capacity to manufacture both iNK and iT cells, as well as other immune cell types, for complete optionality. We believe that having access to our internal manufacturing facility, along with that of FCDI, will increase clinical supply availability and provide us with manufacturing and developmental flexibility.
This multi-product, multi-phase facility has the capabilities and capacity to manufacture both iNK and iT cells, as well as other immune cell types, for complete optionality. We believe that having access to our internal manufacturing facility, along with that of FCDI, will increase clinical supply availability and provide us with manufacturing and developmental flexibility.
Our therapeutic approach We are developing a multi-specific CAR-iNK or CAR-iT cell collaboration program to treat relapsed, refractory, and secondary AML in collaboration with Bristol-Myers Squibb. CNTY-104 is a CAR-iNK or CAR-iT collaboration program designed to target at least two tumor- associated antigens of relevance in AML.
Our therapeutic approach We are developing a multi-specific CAR-iNK or CAR-iT cell collaboration program to treat relapsed, refractory, and secondary AML in collaboration with Bristol-Myers Squibb. CNTY-104 is a CAR-iNK collaboration program designed to target at least two tumor-associated antigens of relevance in AML.
In connection with the Collaboration Agreement Bristol-Myers Squibb purchased 2,160,760 shares of the our common stock at a price per share of $23.14, for an aggregate purchase price of $50 million. iCELL Inc.
In connection with the Collaboration Agreement Bristol-Myers Squibb purchased 2,160,760 shares of our common stock at a price per share of $23.14, for an aggregate purchase price of $50 million. iCELL Inc.
With regard to such United States provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications.
With regard to such United States provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications.
Given that the rights granted to us under these patents are non-exclusive, third parties may obtain licenses to these patents and related technology to compete with us.
Given that the rights granted to us under these patents are non-exclusive, third parties may obtain licenses to these patents and related technology to compete with us.
United States development process The process required by the FDA before a biologic product may be marketed in the United States generally involves the following: ● completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices, or cGLP, and applicable requirements for the humane use of laboratory animals or other applicable regulations; ● preparation of clinical trial material in accordance with cGMP; 64 Table of Contents ● submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin; ● approval by an institutional review board, or IRB, reviewing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials according to Current Good Clinical Practices, or cGCP, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity, potency, and efficacy, of the proposed biologic product for its intended use; ● submission to the FDA of a Biologics License Application, or BLA, for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; ● satisfactory completion of an FDA inspection prior to BLA approval of the manufacturing facility or facilities where the biologic product is produced to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity; ● potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; ● potential FDA Advisory Committee meeting to elicit expert input on critical issues and including a vote by external committee members; ● FDA review and approval, or licensure, of the BLA, and payment of associated user fees, when applicable; and ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategies, or REMS, and the potential requirement to conduct post-approval studies.
United States development process The process required by the FDA before a biologic product may be marketed in the United States generally involves the following: ● completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices, or cGLP, and applicable requirements for the humane use of laboratory animals or other applicable regulations; ● preparation of clinical trial material in accordance with cGMP; ● submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin; ● approval by an institutional review board, or IRB, reviewing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials according to Current Good Clinical Practices, or cGCP, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity, potency, and efficacy, of the proposed biologic product for its intended use; ● submission to the FDA of a Biologics License Application, or BLA, for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; ● satisfactory completion of an FDA inspection prior to BLA approval of the manufacturing facility or facilities where the biologic product is produced to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity; ● potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; ● potential FDA Advisory Committee meeting to elicit expert input on critical issues and including a vote by external committee members; ● FDA review and approval, or licensure, of the BLA, and payment of associated user fees, when applicable; and 73 Table of Contents ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategies, or REMS, and the potential requirement to conduct post-approval studies.
These features include (i) our Allo-Evasion TM technology to enable the cells to avoid detection by the host immune system; (ii) a safety switch to allow for the rapid elimination of the cells from the patient if necessary;(iii) the inclusion of a homeostatic cytokine, IL-15, which promotes increased functionality and persistence in vivo , and is specific to NK cell therapy candidates; and (iv) a positron emission tomography, or PET, reporter molecule to allow for tracing of the distribution of cells upon administration, a capability we intend to include in our future product candidates.
These features may include (i) our Allo-Evasion TM technology to enable the cells to avoid detection by the host immune system; (ii) a safety switch to allow for the rapid elimination of the cells from the patient if necessary;(iii) the inclusion of a homeostatic cytokine, IL-15, which promotes increased functionality and persistence in vivo , and is specific to NK cell therapy candidates; and (iv) a positron emission tomography, or PET, reporter molecule to allow for tracing of the distribution of cells upon administration, a capability we intend to include in our future product candidates.
FCDI currently maintains a cGMP compliant manufacturing facility in Madison, Wisconsin and our audit of the facility confirmed its Phase 1 readiness. We also intend to source clinical trial supply for our other iNK product candidates, and we will have the option to source NK cell therapies to be sold commercially, if approved, from FCDI.
FCDI currently maintains a cGMP compliant manufacturing facility in Madison, Wisconsin and our audit of the facility confirmed its Phase 1 readiness. We also intend to source clinical trial supply for some of our other iNK product candidates, and we will have the option to source NK cell therapies to be sold commercially, if approved, from FCDI.
We will also characterize multiple doses per cycle with repeat cycles without subsequent lymphodepletion, subject to the Independent Data Review Committee and FDA review, and its potential impact on safety, persistence, and efficacy in Schedule B. The ongoing ELiPSE-1 trial is designed to evaluate preliminary safety and efficacy in patients.
We will also characterize multiple doses per cycle with repeat cycles without subsequent lymphodepletion, subject to the Independent Data Monitoring Committee and FDA review, and its potential impact on safety, persistence, and efficacy in Schedule B. The ongoing ELiPSE-1 trial is designed to evaluate preliminary safety and efficacy in patients.
We integrate these core features into common engineered iPSC progenitors, which have several advantages: Significant acceleration of new product candidate generation. Multiple product candidates are generated by engineering additional features, such as adding different CARs to the common progenitor to create new product candidates for different tumor indications.
We integrate these core features into common engineered iPSC progenitors, which have several advantages: Significant acceleration of new product candidate generation Multiple product candidates are generated by engineering additional features, such as adding different CARs to the common progenitor to create new product candidates for different indications.
We are initially focused on advancing the research, clinical development and commercialization of tumor-targeted iNK and iT cell therapeutics. We believe that our iPSC-derived allogeneic cell therapy platforms have the potential to overcome the limitations of existing therapies, lower manufacturing costs and improve patient outcomes.
We are initially focused on advancing the research, clinical development and commercialization of targeted iNK and iT cell therapeutics. We believe that our iPSC-derived allogeneic cell therapy platforms have the potential to overcome the limitations of existing therapies, lower manufacturing costs and improve patient outcomes.
Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, we paid to FCDI (i) an upfront payment of $10 million, and will pay (ii) a percentage of any milestone payments received by us under the Collaboration Agreement in respect of achievement of development or regulatory milestones specific to Japan, and (iii) a percentage of all royalties received by us under the Collaboration Agreement in respect of sales of products in Japan. 55 Table of Contents Manufacturing Agreement Under the Manufacturing Agreement, FCDI will perform certain agreed upon technology transfer, process development, analytical testing, and cGMP manufacturing services for us with respect to clinical supply of our product candidates as agreed to in future work orders.
Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, we paid to FCDI (i) an upfront payment of $10 million, and will pay (ii) a percentage of any milestone payments received by us under the Collaboration Agreement in respect of achievement of development or regulatory milestones specific to Japan, and (iii) a percentage of all royalties received by us under the Collaboration Agreement in respect of sales of products in Japan. 63 Table of Contents Manufacturing Agreement Under the Manufacturing Agreement, FCDI will perform certain agreed upon technology transfer, process development, analytical testing, and cGMP manufacturing services for us with respect to clinical supply of our product candidates as agreed to in future work orders.
Our use of a multi-targeted CAR is intended to increase depth and durability of response by eliminating the effect of CD19 antigen loss that has been observed as a factor limiting durability of CAR-T cell therapies, as well as taking advantage of targeting CD22, an independently regulated, ubiquitous and validated B-cell target. 48 Table of Contents CNTY-102 ​ iT cells are expected to have high proliferative capacity, persistence, and trafficking, leading to sustained anti-tumor activity.
Our use of a multi-targeted CAR is intended to increase depth and durability of response by eliminating the effect of CD19 antigen loss that has been observed as a factor limiting durability of CAR-T cell therapies, as well as taking advantage of targeting CD22, an independently regulated, ubiquitous and validated B-cell target. 56 Table of Contents CNTY-102 ​ iT cells are expected to have high proliferative capacity, persistence and trafficking, leading to sustained anti-tumor activity.
A non-engineered iPSC line that carries an intact β 2M gene was used to prepare iNK cells that are HLA-I + . A version of the same iPSC line was then engineered to knockout (KO) the gene β 2M in order to ablate HLA-I expression.
A non-engineered iPSC line that carries an intact β 2M gene was used to prepare iNK cells that are HLA-I + . A version of the same iPSC line was then engineered to knockout, or KO, the gene β 2M in order to ablate HLA-I expression.
The Nectin cell adhesion protein 4 (Nectin-4) is overexpressed in multiple malignancies and has emerged as a possible biomarker and has been validated as target through antibody drug conjugate (ADC) approaches such as enfortumab vedotin.
The Nectin cell adhesion protein 4, or Nectin-4, is overexpressed in multiple malignancies and has emerged as a possible biomarker and has been validated as target through antibody drug conjugate, or ADC, approaches such as enfortumab vedotin.
Our development programs consist of the product candidates illustrated in the pipeline chart below: ​ ​ 8 Table of Contents ​ (1) We are party to an option agreement with Bayer HealthCare LLC, or Bayer, pursuant to which Bayer was granted certain bidding rights relating to the potential transfer of rights with respect to certain product candidates being researched and developed by us which are comprised of iNK cells, macrophages or dendritic cells, and any other product candidate comprised of iNK cells that we develop in the future.
Our development programs consist of the product candidates illustrated in the pipeline chart below: ​ ​ ​ ​ 9 Table of Contents (1) We are party to an option agreement with Bayer HealthCare LLC, or Bayer, pursuant to which Bayer was granted certain bidding rights relating to the potential transfer of rights with respect to certain product candidates being researched and developed by us which are comprised of iNK cells, macrophages or dendritic cells, and any other product candidate comprised of iNK cells that we develop in the future.
Our development programs consist of the product candidates illustrated in the pipeline chart below: 35 Table of Contents ​ ​ (1) We are party to an option agreement with Bayer HealthCare LLC, or Bayer, pursuant to which Bayer was granted certain bidding rights relating to the potential transfer of rights with respect to certain product candidates being researched and developed by us which are comprised of iNK cells, macrophages or dendritic cells, and any other product candidate comprised of iNK cells that we develop in the future.
Our development programs consist of the product candidates illustrated in the pipeline chart below: 36 Table of Contents ​ ​ (1) We are party to an option agreement with Bayer HealthCare LLC, or Bayer, pursuant to which Bayer was granted certain bidding rights relating to the potential transfer of rights with respect to certain product candidates being researched and developed by us which are comprised of iNK cells, macrophages or dendritic cells, and any other product candidate comprised of iNK cells that we develop in the future.
As is presented in the illustration below, we observed viable iNK cells in the lungs and peripheral blood of mice 20 days after a single administration of CAR-iNK cells with IL-15, a result which was not noted in mice administered CAR- iNK cells without the addition of the cytokine. 29 Table of Contents The addition of a homeostatic cytokine significantly enhances iNK persistence ​ ​ iNK cells were engineered to express a CD19-specific CAR molecule as well as secreted IL-15 to enhance iNK persistence in vivo.
As is presented in the illustration below, we observed viable iNK cells in the lungs and peripheral blood of mice 20 days after a single administration of CAR-iNK cells with IL-15, a result which was not noted in mice administered CAR-iNK cells without the addition of the cytokine. 30 Table of Contents The addition of a homeostatic cytokine significantly enhances iNK persistence ​ ​ iNK cells were engineered to express a CD19-specific CAR molecule as well as secreted IL-15 to enhance iNK persistence in vivo.
Notably this study was conducted using bulk engineered material, prior to single cell cloning, which we believe has the potential to enhance anti-tumor activity. 28 Table of Contents Our CAR-iNK cells have robust anti-tumor activity in vivo ​ ​ The above chart displays Daudi tumor growth inhibition, or TGI, of mice treated with CD19-CAR-iNK cells administered under three different dose schedules.
Notably this study was conducted using bulk engineered material, prior to single cell cloning, which we believe has the potential to enhance anti-tumor activity. 29 Table of Contents Our CAR-iNK cells have robust anti-tumor activity in vivo ​ ​ The above chart displays Daudi tumor growth inhibition, or TGI, of mice treated with CD19-CAR-iNK cells administered under three different dose schedules.
This is a challenge we plan to overcome by selecting Trusted TCRs that do not mediate GvHD. 30 Table of Contents We are exploring two major T cell subsets to develop our iT cell platform ​ ​ Proprietary Trusted TCR constructs enable our generation of TrueT TM cells Many companies that are pursing the development of allogeneic T cell therapies engineer T cell with an intentionally deleted TCR to eliminate the risk of GvHD.
This is a challenge we plan to overcome by selecting Trusted TCRs that do not mediate GvHD. 31 Table of Contents We are exploring two major T cell subsets to develop our iT cell platform ​ ​ Proprietary Trusted TCR constructs enable our generation of TrueT TM cells Many companies that are pursing the development of allogeneic T cell therapies engineer T cell with an intentionally deleted TCR to eliminate the risk of GvHD.
CNTY-106 is a CAR-iNK or CAR-iT collaboration program to target at least two tumor- associated antigens of relevance in multiple myeloma. Discovery platform In addition to our named programs, we are actively engaged in a number of earlier stage discovery programs where we believe our IPSC-derived allogeneic cell therapy platform may provide differentiated therapeutic 51 Table of Contents benefits.
CNTY-106 is a CAR-iNK or CAR-iT collaboration program to target at least two tumor-associated antigens of relevance in multiple myeloma. Discovery platform In addition to our named programs, we are actively engaged in a number of earlier stage discovery programs where we believe our IPSC-derived allogeneic cell therapy platform may provide differentiated therapeutic 59 Table of Contents benefits.
The therapeutic properties offered by T cells, such as large in vivo expansion capacity, extended immune memory and the potential inclusion of engineered TCRs for additional tumor killing capacity, provide compelling reasons supporting their inclusion in our anti-cancer cell therapy arsenal. However, the development of allogeneic T cell-based therapies requires addressing unique challenges, such as GvHD.
The therapeutic properties offered by T cells, such as large in vivo expansion capacity, extended immune memory and the potential inclusion of engineered TCRs for additional tumor killing capacity, provide compelling reasons supporting their inclusion in our anti-cancer and autoimmune and inflammatory cell therapy arsenal. However, the development of allogeneic T cell-based therapies requires addressing unique challenges, such as GvHD.
Right panel: NALM-6 tumor growth inhibition of mice treated with CD19-CAR-iNK cells The CD19-CAR-iNK cells were administered intravenously at 1x10 7 cells per mouse on Days 1, 8, and 15, as indicated by the arrows. CD19-CAR-iNK cells demonstrate statistically significant (p=0.0133) anti-tumor growth inhibition compared to untreated control animals (“Tumor only”).
Right panel: NALM-6 tumor growth inhibition of mice treated with CD19-CAR-iNK cells The CD19-CAR-iNK cells were administered intravenously at 1x10 7 cells per mouse on Days 1, 8, and 15, as indicated by the arrows. CD19-CAR-iNK cells demonstrated statistically significant (p=0.0133) anti-tumor growth inhibition compared to untreated control animals (“Tumor only”).
Differentiation License Agreement Under the Differentiation License, FCDI granted us an exclusive, fully paid-up, sublicensable, worldwide, excluding Japan, license under certain patent rights and know-how related to human iPSC to exploit cancer 53 Table of Contents immunotherapy products consisting of cells that are or are modifications of NK cells, T cells, dendritic cells and macrophages derived from human iPSC, or FCDI Licensed Products.
Differentiation License Agreement Under the Differentiation License, FCDI granted us an exclusive, fully paid-up, sublicensable, worldwide, excluding Japan, license under certain patent rights and know-how related to human iPSC to exploit cancer 61 Table of Contents immunotherapy products consisting of cells that are or are modifications of NK cells, T cells, dendritic cells and macrophages derived from human iPSC, or FCDI Licensed Products.
We also agreed to pay certain milestone payments to FCDI as required by the WARF License upon the achievement of certain development and commercial milestones up to an aggregate of $6 million per FCDI Licensed Product. 54 Table of Contents The Reprogramming License expires upon the expiration of the last-to-expire patent licensed thereunder, which is currently expected to expire in 2034.
We also agreed to pay certain milestone payments to FCDI as required by the WARF License upon the achievement of certain development and commercial milestones up to an aggregate of $6 million per FCDI Licensed Product. 62 Table of Contents The Reprogramming License expires upon the expiration of the last-to-expire patent licensed thereunder, which is currently expected to expire in 2034.
Decreasing RCU indicates tumor cell killing by γδ CAR-iT cells or PBMC CAR-T cells. 34 Table of Contents Collectively, we have made significant progress in deriving iPSC lines that carry Trusted TCRs as well as refining the differentiation process to generate TrueT TM cells that express a TCR and a CAR.
Decreasing RCU indicates tumor cell killing by γδ CAR-iT cells or PBMC CAR-T cells. 35 Table of Contents Collectively, we have made significant progress in deriving iPSC lines that carry Trusted TCRs as well as refining the differentiation process to generate TrueT TM cells that express a TCR and a CAR.
We have optimized our use of CRISPR-MAD7 to enable CRISPR-mediated homologous recombination and repair of multiple edits per iPSC. CRISPR mediated homologous recombination/repair ​ ​ 19 Table of Contents Advantages of our proprietary Allo-Evasion TM technology We believe that our Allo-Evasion TM engineering technology will allow our cell product candidates to escape recognition and destruction by the host immune system.
We have optimized our use of CRISPR-MAD7 to enable CRISPR-mediated homologous recombination and repair of multiple edits per iPSC. 20 Table of Contents CRISPR mediated homologous recombination/repair ​ ​ Advantages of our proprietary Allo-Evasion TM technology We believe that our Allo-Evasion TM engineering technology will allow our cell product candidates to escape recognition and destruction by the host immune system.
Our license covers the making and using of CRISPR-MAD7 for editing iPSCs, making master engineered iPSC lines and using master engineered iPSC lines to manufacture human therapeutic products. These issued patents and any patents that may issue from these pending patent applications will expire in 2037, without giving effect to any patent term adjustment or extension.
Our license covers the making and using of CRISPR-MAD7 for editing iPSCs, making master engineered iPSC lines and using master engineered iPSC lines to manufacture human therapeutic products. These issued patents and any patents that may be issued from these pending patent applications will expire in 2037, without giving effect to any patent term adjustment or extension.
The royalty term shall terminate on a Licensed Product-by-Licensed Product and country-by-country basis on the latest of (i) the twelve (12) year anniversary of the first commercial sale of such Licensed Product in such country, (ii) the expiration of any regulatory exclusivity period that covers such Licensed Product in such country, and (iii) the expiration of the last-to-expire licensed patent of the Company or a jointly owned patent that covers such the Licensed Product in such country.
The royalty term shall terminate on a Licensed Product-by-Licensed Product and country-by-country basis on the latest of (i) the twelve (12) year anniversary of the first commercial sale of such Licensed Product in such country, (ii) the expiration of any regulatory exclusivity period that covers such Licensed Product in such country, and (iii) the expiration of the last-to-expire licensed patent of ours or a jointly owned patent that covers such the Licensed Product in such country.
Prior to the institution of 68 Table of Contents any manufacturing changes, a determination needs to be made whether FDA approval is required in advance. If not done in accordance with FDA expectations, the FDA may restrict supply and may take further action. Annual product reports are required to be submitted annually.
Prior to the institution of any manufacturing changes, a determination needs to be made whether FDA approval is required in advance. If not done in accordance with FDA expectations, the FDA may restrict supply and may take further 77 Table of Contents action. Annual product reports are required to be submitted annually.
Examples of this include the potential reduction of the risk of graft-versus-host disease, or GvHD, in iT cells through the use of TCRs that are not expected to cause GvHD, which we refer to herein as Trusted TCRs, or the potential extension of cell persistence of NK cells through the addition of cytokine signaling to promote survival.
Examples of this include the potential reduction of the risk of graft-versus-host disease, or GvHD, in iT cells through the use of TCRs that are not expected to cause GvHD, which we refer to herein as TrustedTCRs, or the potential extension of cell persistence of NK cells through the addition of cytokine signaling to promote survival.
In combination with the extended killing capability of optimized immune cells derived from single genetically engineered cell cloning, we envision utilizing repeat dosing to maximize durability of response and efficacy. Additionally, we believe this technology may permit dosing in patients with limited or no immune preconditioning regimens.
In combination with the extended killing capability of optimized immune cells derived from single genetically engineered cell clone, we envision utilizing repeat dosing to maximize durability of response and efficacy. Additionally, we believe this technology may permit dosing in patients with limited or no immune preconditioning regimens.
We are also committing additional resources to ensure that adequate infrastructure and expertise is available at clinical sites regarding handling and treatment preparation. 52 Table of Contents Effective cryopreservation strategies must consider all elements of the supply chain ​ ​ We are sourcing clinical supply of CNTY-101 from FCDI.
We are also committing additional resources to ensure that adequate infrastructure and expertise is available at clinical sites regarding handling and treatment preparation. 60 Table of Contents Effective cryopreservation strategies must consider all elements of the supply chain ​ ​ We are sourcing clinical supply of CNTY-101 from FCDI.
Additionally, we may be subject to state laws that require pharmaceutical 75 Table of Contents companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state laws that require drug and biologics manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.
Additionally, we may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state laws that require drug and biologics manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.
Our lead clinical product candidate, CNTY-101, incorporates six gene edits, which we believe are essential attributes necessary for meaningful clinical performance, including a CAR to mediate tumor recognition and killing, features to evade immune rejection and a safety switch to enable product elimination if ever necessary.
Our lead clinical product candidate, CNTY-101, incorporates six gene edits, which we believe are essential attributes necessary for meaningful clinical performance, including a CAR to mediate target recognition and killing, features to evade immune rejection and a safety switch to enable product elimination if ever necessary.
This is the case even when the studies’ 73 Table of Contents results are negative. For orphan medicinal products, the incentive is an additional two years of market exclusivity. Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of pediatric medicines.
This is the case even when the studies’ results are negative. For orphan medicinal products, the incentive is an additional two years of market exclusivity. 82 Table of Contents Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of pediatric medicines.
Because multiple clinical candidates are derived from the same engineered iPSC line, the lessons learned from one product candidate can be leveraged across multiple product candidates, which facilitates further product development. For instance, we believe the allo-reactivity of products derived from the same common engineered iPSC progenitor should be very similar.
Predictability of product candidate profile Because multiple clinical candidates are derived from the same engineered iPSC line, the lessons learned from one product candidate can be leveraged across multiple product candidates, which facilitates further product development. For instance, we believe the allo-reactivity of products derived from the same common engineered iPSC progenitor should be very similar.
Because the T-iPSC line was also engineered with a CAR transgene, the CAR protein was also detected on the surface of these iT cells (right panel). 33 Table of Contents αβ CAR-iT cells kill CD19-expressing lymphoma cells ​ ​ CAR-iT cells were used in a tumor cell killing assay on an IncuCyte instrument.
Because the T-iPSC line was also engineered with a CAR transgene, the CAR protein was also detected on the surface of these iT cells (right panel). 34 Table of Contents αβ CAR-iT cells kill CD19-expressing lymphoma cells ​ ​ CAR-iT cells were used in a tumor cell killing assay on an IncuCyte instrument.
The T cells also retained high expression of the CAR molecule. 32 Table of Contents γδ CAR-iT cells kill CD19-expressing lymphoma cells ​ ​ CAR-iT cells were used in a tumor cell killing assay on an IncuCyte instrument. For this study, Reh cells, a CD19- expressing lymphoma line was used.
The T cells also retained high expression of the CAR molecule. 33 Table of Contents γδ CAR-iT cells kill CD19-expressing lymphoma cells ​ ​ CAR-iT cells were used in a tumor cell killing assay on an IncuCyte instrument. For this study, Reh cells, a CD19- expressing lymphoma line was used.
As evidenced in the comparison presented above, NK cells derived from our iPSC- derived allogeneic cell therapy platforms are similar to primary human NK cells recovered from peripheral blood, with the phenotypic markers we evaluated displaying close alignment and the slight differences observed reflecting expected person-to-person variation. 25 Table of Contents Assessment of these cells’ functionality demonstrates their potential for tumor cell cytotoxicity.
As evidenced in the comparison presented above, NK cells derived from our iPSC-derived allogeneic cell therapy platforms are similar to primary human NK cells recovered from peripheral blood, with the phenotypic markers we evaluated displaying close alignment and the slight differences observed reflecting expected person-to-person variation. Assessment of these cells’ functionality demonstrates their potential for tumor cell cytotoxicity.
Nectin-4 is overexpressed in tumor types including urothelial, colorectal, breast, lung, ovarian, gastric, esophageal and pancreatic cancer. 49 Table of Contents CNTY-107 CNTY-104: Our CAR-iNK or CAR-iT multi-specific collaboration program for the treatment of acute myeloid leukemia Disease background AML is the most common form of acute leukemia, with 20,000 patients per year diagnosed in US.
Nectin-4 is overexpressed in tumor types including urothelial, colorectal, breast, lung, ovarian, gastric, esophageal and pancreatic cancer. 57 Table of Contents CNTY-104: Our CAR-iNK or CAR-iT multi-specific collaboration program for the treatment of acute myeloid leukemia Disease background AML is the most common form of acute leukemia, with 20,000 patients per year diagnosed in US.
Tumor cell index measures the density of tumor cells in the wells and is calculated as (tumor and iNK well at time x / tumor only well at time x) / (tumor and iNK well at first time point) * 100. Our iNK cells also demonstrate the ability to engage and kill cancerous cells through multiple challenge rounds.
Tumor cell index measures the density of tumor cells in the wells and is calculated as (tumor and iNK well at time x / tumor only well at time x) / (tumor and iNK well at first time point) * 100. Our iNK cells also demonstrated the ability to engage and kill cancerous cells through multiple challenge rounds.
In each of these areas, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall products, and withdraw approvals. Information about certain clinical trials must be submitted within specific timeframes to the NIH for public dissemination on its clinicaltrials.gov website.
In each of these areas, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall products, and withdraw approvals. 75 Table of Contents Information about certain clinical trials must be submitted within specific timeframes to the NIH for public dissemination on its clinicaltrials.gov website.
These issued patents will expire in 2031, without giving effect to any patent term adjustment or extension. Competition The biotechnology and pharmaceutical industries have made substantial investments in recent years into the rapid development of novel immunotherapies for the treatment of a range of pathologies, including infectious diseases and cancers, making this a highly competitive market.
These issued patents will expire in 2031, without giving effect to any patent term adjustment or extension. 71 Table of Contents Competition The biotechnology and pharmaceutical industries have made substantial investments in recent years into the rapid development of novel immunotherapies for the treatment of a range of pathologies, including infectious diseases and cancers, making this a highly competitive market.
We have created comprehensive allogeneic cell therapy platforms that include industry-leading iPSC differentiation know- how, CRISPR-mediated precision gene editing, sophisticated protein engineering capabilities, proprietary Allo-EvasionTM technology, and cutting-edge manufacturing capabilities.
We have created comprehensive allogeneic cell therapy platforms that include industry-leading iPSC differentiation know-how, CRISPR-mediated precision gene editing, sophisticated protein engineering capabilities, proprietary Allo-Evasion ™ technology, and cutting-edge manufacturing capabilities.
University of Toronto and McMaster University On June 9, 2020, we entered into an asset purchase agreement by and among Empirica, our wholly-owned subsidiary Century Therapeutics Canada ULC, or Century Canada and us pursuant to which we purchased certain assets of Empirica, including a license agreement, or the Empirica License, dated January 22, 2019, by and among the Governing Council of the University of Toronto, or the Council, the McMaster University, or, together with the Council, the Toronto Universities, and Empirica.
University of Toronto and McMaster University On June 9, 2020, we entered into an asset purchase agreement by and among Empirica, our wholly-owned subsidiary Century Therapeutics Canada ULC, or Century Canada and us pursuant to which we purchased certain assets of Empirica, including a license agreement, the Empirica License, dated January 22, 2019, by 66 Table of Contents and among the Governing Council of the University of Toronto, or the Council, the McMaster University, or, together with the Council, the Toronto Universities, and Empirica.
We believe the incorporation of these elements into our platforms affords us numerous advantages over autologous and donor-derived differentiated T, NK and other cell therapies, and may eliminate many of the challenges inherent in these other cell therapy modalities. • Maximize the potential to treat a broad range of cancers by exploiting the distinct biologies of both NK and T cells.
We believe the incorporation of these elements into our platforms affords us numerous advantages over autologous and donor-derived differentiated T, NK and other cell therapies, and may eliminate many of the challenges inherent in these other cell therapy modalities. • Maximize the potential to treat a broad range of cancers and autoimmune and inflammatory diseases by exploiting the distinct biologies of both NK and T cells.
Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.
Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state 86 Table of Contents legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.
Our agreements with employees also provide that all inventions conceived by the employee in the course of employment with us or from the employee’s use of our confidential information are our exclusive property. However, such confidentiality agreements and invention 61 Table of Contents assignment agreements can be breached and we may not have adequate remedies for any such breach.
Our agreements with employees also provide that all inventions conceived by the employee in the course of employment with us or from the employee’s use of our confidential information are our exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached, and we may not have adequate remedies for any such breach.
Under the license agreement, we obtained a non-exclusive, royalty-free, irrevocable license to a patent portfolio covering the composition, production and use of CRISPR-MAD7, a novel gene-editing CRISPR endonuclease from the Eubacterium rectale genome. The intellectual property includes two issued U.S. patents and any pending applications claiming priority therefrom.
Under the license agreement, we obtained a non-exclusive, royalty-free, irrevocable license to a patent portfolio covering the composition, production and use of CRISPR-MAD7, a novel gene-editing CRISPR endonuclease from the Eubacterium rectale genome. The intellectual property includes two issued U.S. patents and any pending 70 Table of Contents applications claiming priority therefrom.
Additionally, we believe our investment in our gene editing technology will allow us to expand upon our current capabilities and integrate further fit for purpose gene edits intended to enhance clinical performance of our future product candidates. 12 Table of Contents • Leverage our own manufacturing infrastructure, product and process understanding, and scale-up technologies to minimize manufacturing risk.
Additionally, we believe our investment in our gene editing technology will allow us to expand upon our current capabilities and integrate further fit for purpose gene edits intended to enhance clinical performance of our future product candidates. • Leverage our own manufacturing infrastructure, product and process understanding and scale-up technologies to minimize manufacturing risk.
CNTY-107: Our CAR-iT candidate targeting Nectin-4, for solid tumors expressing high levels of the target antigen CNTY-107 is an iPSC-derived Allo- EvasionTM technology enabled, CAR-iT cell therapy designed to address Nectin-4 positive solid tumors. CNTY-107 will also incorporate additional functionalities to enhance tumor cell killing and improve cell fitness.
CNTY-107: Our CAR-iT candidate targeting Nectin-4, for solid tumors expressing high levels of the target antigen CNTY-107 is an iPSC-derived Allo-Evasion TM technology enabled, CAR-iT cell therapy designed to address Nectin-4 positive solid tumors. CNTY-107 will also incorporate additional functionalities to enhance tumor cell killing and improve cell fitness.
We also rely on trade secrets that 59 Table of Contents may be important to the development of our business, but which may be difficult to protect and provide us with only limited protection. We expect to file additional patent applications in support of current and new clinical candidates as well as new platform and core technologies.
We also rely on trade secrets that may be important to the development of our business, but which may be difficult to protect and provide us with only limited protection. We expect to file additional patent applications in support of current and new clinical candidates as well as new platform and core technologies.
They are also shown to be effective in aggressive and indolent 36 Table of Contents lymphoma subpopulations and are in active testing in second line lymphoma. While these treatments have transformed care, significant medical need still exists in the relapsing and progressing patients that remain, with additional limitations of the autologous therapies described herein.
They are also shown to be effective in aggressive and indolent lymphoma subpopulations and are in active testing in second line lymphoma. While these treatments have transformed care, significant medical need still exists in the relapsing and progressing patients that remain, with additional limitations of the autologous therapies described herein.
Through this enhanced control and investment in our process and analytical development capabilities, we believe we will gain a deeper understanding of our critical product attributes and better understand the factors that affect product quality.
Through this enhanced control and investment in our process and analytical development capabilities, we believe we will gain a deeper understanding of our critical product attributes and the factors that affect product quality.
We have developed proof of concept for approached using an iPSC line that was derived from non-T cells, in this case CD34+ peripheral blood hematopoietic cells, where we introduced a viral-specific TCR. 31 Table of Contents Differentiation of TrueT TM cells results in cells that co-express TCR and CD3 and can utilize an engineered CAR for target cell killing The process for differentiating T cells from iPSC is a multistage in vitro system that includes several growth factors and key ligands that mimic the developmental signals found in the human thymus where T cells normally develop.
We have developed proof of concept for approached using an iPSC line that was derived from non-T cells, in this case CD34+ peripheral blood hematopoietic cells, where we introduced a viral-specific TCR. 32 Table of Contents Differentiation of TrueT TM cells results in cells that co-express TCR and CD3 and can utilize an engineered CAR for target cell killing The process for differentiating T cells from iPSC is a multi-stage in vitro system that includes several growth factors and key ligands that mimic the developmental signals found in the human thymus where T cells normally develop.
In addition to our named programs, we are actively engaged in a number of earlier stage discovery programs where we believe our iPSC-derived allogeneic cell therapy platform may provide differentiated therapeutic benefits. These discovery stage initiatives are focused on several solid tumor indications including renal cell carcinoma and other indications.
Discovery platform In addition to our named programs, we are actively engaged in a number of earlier stage discovery programs where we believe our iPSC-derived allogeneic cell therapy platform may provide differentiated therapeutic benefits. These discovery stage initiatives are focused on several solid tumor indications including bladder cancer and renal cell carcinoma.
These results suggest that not only are the cells capable of retaining functionality and the ability to proliferate, but that the cytolytic machinery and signaling mechanism connecting target recognition to effector immune cells maintains sustained durability as well. 27 Table of Contents Our CAR-iNK cells have robust serial killing activity against lymphoma cells ​ ​ Our CAR-iNK cells were incubated with Reh tumor cells labelled with NLR for multiple rounds of killing.
We believe these results suggest that not only are the cells capable of retaining functionality and the ability to proliferate, but that the cytolytic machinery and signaling mechanism connecting target recognition to effector immune cells maintains sustained durability as well. 28 Table of Contents Our CAR-iNK cells have robust serial killing activity against lymphoma cells ​ ​ Our CAR-iNK cells were incubated with Reh tumor cells labelled with NLR for multiple rounds of killing.
We retain exclusive commercialization rights in the United States and other major commercial markets for our product candidates developed pursuant to our collaboration with FCDI. Our pipeline We are assembling a portfolio of allogeneic iNK and iT cell therapy product candidates across solid tumor and hematological malignancies.
We retain exclusive commercialization rights in the United States and other major commercial markets for our product candidates developed pursuant to our collaboration with FCDI. Our pipeline We are assembling a portfolio of allogeneic iNK and iT cell therapy product candidates across solid tumor and hematological malignancies, and in autoimmune and inflammatory diseases.
Results from these studies and trials have fueled increasing levels of interest in the field of immunotherapy. 63 Table of Contents Large pharmaceutical companies that have commercialized or are developing immunotherapies to treat cancer include AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Pfizer, and Roche/Genentech.
Results from these studies and trials have fueled increasing levels of interest in the field of immunotherapy. Large pharmaceutical companies that have commercialized or are developing immunotherapies to treat cancer include AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Pfizer, and Roche/Genentech.
If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. Clinical trials may involve the administration of the biologic product candidate to healthy volunteers or subjects under the supervision of qualified investigators, generally physicians not employed by or under the 65 Table of Contents study sponsor’s control.
If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. Clinical trials may involve the administration of the biologic product candidate to healthy volunteers or subjects under the supervision of qualified investigators, generally physicians not employed by or under the study sponsor’s control.
Letter Agreement Under the letter agreement, which amends certain terms of each of the FCDI Agreements, including such amendments that (i) amend the definition of Territory under each of the FCDI Agreements, for purposes of the sublicenses under the FCDI Agreements pursuant to the Company’s Research Collaboration and License Agreement with Bristol-Myers Squibb dated January 7, 2022, or the Collaboration Agreement, includes Japan, (ii) amends the licenses granted to the Company and its affiliates under the FCDI Agreements such that the rights are sublicensable to Bristol-Myers Squibb, including with respect to Japan and (iii) the intellectual property developed under the Bristol-Myers Squibb collaboration is not subject to grant-back and option provisions under the Reprogramming License (iv) waives any right of FCDI to manufacture products developed under the Collaboration Agreement.
Letter Agreement Under the letter agreement, which amends certain terms of each of the FCDI Agreements, including such amendments that (i) amend the definition of Territory under each of the FCDI Agreements, for purposes of the sublicenses under the FCDI Agreements pursuant to our Research Collaboration and License Agreement with Bristol-Myers Squibb dated January 7, 2022, or the Collaboration Agreement, includes Japan, (ii) amends the licenses granted to us and our affiliates under the FCDI Agreements such that the rights are sublicensable to Bristol-Myers Squibb, including with respect to Japan and (iii) the intellectual property developed under the Bristol-Myers Squibb collaboration is not subject to grant-back and option provisions under the Reprogramming License (iv) waives any right of FCDI to manufacture products developed under the Collaboration Agreement.
We believe these advantages could enable the implementation of more flexible and effective dosing protocols for our off-the-shelf product candidates, which we anticipate will increase physician and patient access. • Exploit serial gene editing of iPSCs to create product candidates with enhanced functionalities and fit for purpose product characteristics.
We believe these advantages could enable the implementation of more flexible and effective dosing protocols for our off-the-shelf product candidates, which may increase physician and patient access. • Exploit serial gene editing of iPSCs to create product candidates with enhanced functionalities and fit for purpose product characteristics.
The PCT searching authority performs a patentability search and issues a non-binding 60 Table of Contents patentability opinion for some or all of the claims filed in the application, which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees.
The PCT searching authority performs a patentability search and issues a non-binding patentability opinion for some or all of the claims filed in the application, which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees.
These issued patents and any patents that may issue from these pending patent applications will expire on dates ranging from 2029 to 2034, without giving effect to any patent term adjustment or extension.
These issued patents and any patents that may be issued from these pending patent applications will expire on dates ranging from 2029 to 2034, without giving effect to any patent term adjustment or extension.
The information contained in, or that can be accessed through, our website is not part of this Annual Report on Form 10-K. ​ 78 Table of Contents
The information contained in, or that can be accessed through, our website is not part of this Annual Report on Form 10-K. ​ 88 Table of Contents
A single engineered iPSC progenitor can be used for multiple product candidates ​ ​ Highly efficient engineering processes We have designed highly efficient engineering processes to generate our product candidates. During the engineering process, we frequently combine the knock-out of specific genes with the knock-in of transgenes we seek to express.
A single engineered iPSC progenitor can be used for multiple product candidates ​ ​ 19 Table of Contents Highly efficient engineering processes We have designed highly efficient engineering processes to generate our product candidates. During the engineering process, we frequently combine the knock-out of specific genes with the knock-in of transgenes we seek to express.
Part I is assessed by a coordinated review by the competent authorities of all European Union Member States in which an application for authorization of a clinical trial has been submitted (Concerned Member States) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Concerned Member State.
Part I is assessed by a coordinated review by the competent authorities of all European Union Member States in 80 Table of Contents which an application for authorization of a clinical trial has been submitted (Concerned Member States) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Concerned Member State.
In the event that Bayer exercises its ROFR right, we will provide Bayer with our current, minimum offer terms with respect to the relevant Research Product Rights, or the Minimum Offer Terms, as determined by our Board (excluding any director appointed by Bayer), which will include (i) the minimum upfront cash proceeds to be received by us for the Research Product Rights and (ii) any other applicable licensing and financial terms.
In the event that Bayer exercises its ROFR right, we will provide Bayer with our current, minimum offer terms with respect to the relevant Research Product Rights, or the Minimum Offer Terms, as determined by our 64 Table of Contents Board (excluding any director appointed by Bayer), which will include (i) the minimum upfront cash proceeds to be received by us for the Research Product Rights and (ii) any other applicable licensing and financial terms.
For these and other indications, we plan to use multispecific CARs and explore the use of both iNK and iT cells to identify the best cell platform to build the product candidate. We continue to advance our gamma delta and alpha beta iT cell platforms for our future T cell based candidates.
For these and other indications, we plan to use multi-specific CARs and explore the use of both iNK and iT cells to identify the best cell platform to build the product candidate. We continue to advance our gamma delta and alpha beta iT cell platforms for our future T cell based candidates.
With respect to each Licensed Program, Bristol-Myers Squibb will pay up to $235 million in milestone payments upon the first achievement of certain development and regulatory milestones within such Licensed Program. In addition, Bristol-Myers Squibb will pay up to $500 million per Licensed Product in net sales-based milestone payments.
With respect to each Licensed Program, Bristol- 65 Table of Contents Myers Squibb will pay up to $235 million in milestone payments upon the first achievement of certain development and regulatory milestones within such Licensed Program. In addition, Bristol-Myers Squibb will pay up to $500 million per Licensed Product in net sales-based milestone payments.
Under this procedure, an applicant submits an application, or dossier, and related materials including a draft SmPC, and draft labeling and package leaflet, to the Reference Member State and Concerned Member States. The Reference Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application.
Under this procedure, an applicant submits an application, or dossier, and related materials including a draft SmPC, and draft labeling and package leaflet, to the Reference Member State and Concerned Member States. The Reference Member State prepares a draft assessment and drafts of the 81 Table of Contents related materials within 120 days after receipt of a valid application.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the biological product approval process, the FDA 67 Table of Contents also will determine whether a REMS is necessary to assure the safe use of the biological product.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the biological product approval process, the FDA also will determine whether a REMS is necessary to assure the safe use of the biological product.
There are two other procedures in the European Union for the grant of an MA in multiple European Union Member States. The decentralized procedure provides for approval by one or more other, or Concerned, Member States of an assessment of an application performed by one Member State, known as the Reference 72 Table of Contents Member State.
There are two other procedures in the European Union for the grant of an MA in multiple European Union Member States. The decentralized procedure provides for approval by one or more other, or Concerned, Member States of an assessment of an application performed by one Member State, known as the Reference Member State.
Genetic knockout of genes necessary for HLA I and II molecule expression removes the targets of recognition by allogeneic CD8 + and CD4 + T cells respectively, but renders the cells susceptible to killing by recipient NK cells (middle panel).
Genetic knockout of genes necessary for HLA I and II molecule expression removes the targets of recognition by allogeneic CD8 + and CD4 + T cells respectively, but renders the cells susceptible 21 Table of Contents to killing by recipient NK cells (middle panel).
From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business. ​ Available Information ​ Our website address is www.centurytx.com.
From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business. 87 Table of Contents ​ Available Information ​ Our website address is www.centurytx.com.
Our preliminary data from in vivo studies indicates that the cetuximab effectively triggers the elimination of iNK cells engineered with our EGFR safety switch from different tissues including blood, liver, and lungs. 40 Table of Contents Elimination of iNK cells using EGFR safety switch ​ ​ NSG mice were intravenously infused with 1x107 CD19iNK and one day later treated with 40 mg/kg cetuximab or rituximab (as a control).
Our preliminary data from in vivo studies indicated that the cetuximab can effectively trigger the elimination of iNK cells engineered with our EGFR safety switch from different tissues including blood, liver and lungs. 40 Table of Contents Elimination of iNK cells using EGFR safety switch ​ ​ NSG mice were intravenously infused with 1x107 CD19iNK and one day later treated with 40 mg/kg cetuximab or rituximab (as a control).
We believe this initial set of gene edits will form the foundation for follow-on product candidate development.
We believe this initial set of gene edits, if successful, will form the foundation for follow-on product candidate development.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

177 edited+52 added−64 removed551 unchanged
Biggest changeOperational issues with our own facility or with third party facilities could delay our development plans and thereby limit our ability to generate revenue; 79 Table of Contents • We could become dependent on Bristol-Myers Squibb Company, or Bristol-Myers Squibb, for development and commercialization activities with respect to certain of our product candidates pursuant to our collaboration with Bristol-Myers Squibb and cannot control whether Bristol-Myers Squibb will devote sufficient attention or resources to this collaboration or proceed in an expeditious manner; • If we are unable to successfully commercialize CNTY-101 or any of our other product candidates for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed; • We face significant competition, and if our competitors develop product candidates more rapidly than we do or their product candidates are more effective, our ability to develop and successfully commercialize products may be adversely affected; • We may face difficulties in obtaining, protecting, maintaining, and enforcing our intellectual property rights, including intellectual property rights that are licensed to us; • We do not currently own any issued patents relating to our product candidates; • Unstable market and economic conditions, including inflation and political unrest, may have serious adverse consequences on our business, financial condition, and stock price; • The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses; and • Our executive officers, directors, principal stockholders, and affiliates continue to exercise significant control over our company, which limits the ability of our other stockholders to influence corporate matters and could delay or prevent a change in corporate control.
Biggest changeOperational issues with our own facility or with third party facilities could delay our development plans and thereby limit our ability to generate revenue; • We could become dependent on Bristol-Myers Squibb Company, or Bristol-Myers Squibb, for development and commercialization activities with respect to certain of our product candidates pursuant to our collaboration with Bristol-Myers Squibb and cannot control whether Bristol-Myers Squibb will devote sufficient attention or resources to this collaboration or proceed in an expeditious manner; We may explore strategic collaborations that may never materialize or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators; • If we are unable to successfully commercialize CNTY-101 or any of our other product candidates for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed; Any pandemic, epidemic, or outbreak of an infectious disease may materially and adversely affect our business and our financial results and could cause a disruption to the development of our drug candidates; • Our success depends on obtaining, protecting, maintaining, and enforcing our intellectual property rights and our proprietary technologies, including intellectual property rights that are licensed to us; • We do not currently own issued patents relating to some of our product candidates; • If any of our license agreements with FUJIFILM Cellular Dynamics Inc., or FCDI, are terminated, we could lose our rights to key components enabling our iPSC-derived allogenic cell therapy platforms; • Our commercial success depends significantly on our ability to operate without infringing, misappropriating, or otherwise violating the patents and other intellectual property and proprietary rights of thirds parties.
We have not yet demonstrated long-term stability of cryopreserved CAR-iNK cells. We have not yet demonstrated long-term stability of cryopreserved CAR-iNK cells and, therefore, do not know if we will be able to store the cryopreserved cells for extended periods of time.
We have not yet demonstrated long-term stability of cryopreserved CAR-iNK cells and, therefore, do not know if we will be able to store the cryopreserved cells for extended periods of time.
We are now operating our own manufacturing facilities and but still rely on FCDI for the manufacture of some of our product candidates and CMOs for the manufacture of related raw materials for clinical and preclinical development.
We are now operating our own manufacturing facilities but still rely on FCDI for the manufacture of some of our product candidates and CMOs for the manufacture of related raw materials for clinical and preclinical development.
During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs, or intellectual property could be diminished.
During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs, or intellectual property could be diminished.
Provisions in our second amended and restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent, a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.
Provisions in our second amended and restated certificate of incorporation and our second amended and restated bylaws may discourage, delay or prevent, a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.
Our second amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our second amended and restated certificate of incorporation and second amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our second amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, our amended and restated certificate of incorporation, or our amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided, that, this provision would not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended, or the Exchange Act.
Our second amended and restated certificate of incorporation and second amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, our amended and restated certificate of incorporation, or our amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided, that, this provision would not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended, or the Exchange Act.
We also may experience numerous unforeseen events during, or as a result of, any of our current clinical trials or future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our lead product candidates or any future product candidates, including: ● regulators or institutional review boards, or IRBs, the FDA, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs as the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● clinical trial sites deviating from trial protocol or dropping out of a trial; ● clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs; ● the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; 92 Table of Contents ● we may elect to, or regulators, IRBs, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our trials are being exposed to unacceptable health risks; ● the cost of clinical trials of any of our product candidates may be greater than we anticipate; ● the quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial; ● our inability to manufacture sufficient quantities of our product candidates for use in clinical trials; ● reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; ● our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other studies or trials in the same class as our product candidate; and ● the FDA or applicable foreign regulatory agencies may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
We also may experience numerous unforeseen events during, or as a result of, any of our current clinical trials or future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our lead product candidates or any future product candidates, including: ● regulators or institutional review boards, or IRBs, the FDA, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs as the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● clinical trial sites deviating from trial protocol or dropping out of a trial; ● clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs; 103 Table of Contents ● the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; ● we may elect to, or regulators, IRBs, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our trials are being exposed to unacceptable health risks; ● the cost of clinical trials of any of our product candidates may be greater than we anticipate; ● the quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial; ● our inability to manufacture sufficient quantities of our product candidates for use in clinical trials; ● reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; ● our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other studies or trials in the same class as our product candidate; and ● the FDA or applicable foreign regulatory agencies may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
These provisions provide, among other things, that: ● our board of directors has the exclusive right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; ● our board of directors is divided into three classes, Class I, Class II, and Class III, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; ● our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; ● a special meeting of stockholders may be called only by the chair of our board of directors, our chief executive officer, or a majority of our board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; ● our second amended and restated certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; ● our board of directors may alter certain provisions of our amended and restated bylaws without obtaining stockholder approval; ● the approval of the holders of at least two-thirds of the outstanding shares of our capital stock is required to adopt, amend, or repeal our amended and restated bylaws, unless such action is recommended by our board of directors at an annual or special meeting of shareholders; ● the approval of the holders of at least two-thirds of the outstanding shares of our capital stock is required to adopt, amend, or repeal provisions in our second amended and restated certificate of incorporation relating to (i) the amendment of the second amended and restated certificate of incorporation or 143 Table of Contents amendment of the amended and restated bylaws, (ii) stockholder action, (iii) election and removal of directors, (iv) limitations on liability and (v) exclusive forum for proceedings; ● stockholders must provide advance notice and additional disclosures to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain voting control of our shares; and ● our board of directors is authorized to issue shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer.
These provisions provide, among other things, that: ● our board of directors has the exclusive right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; ● our board of directors is divided into three classes, Class I, Class II, and Class III, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; ● our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; ● a special meeting of stockholders may be called only by the chair of our board of directors, our chief executive officer, or a majority of our board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; ● our second amended and restated certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; ● our board of directors may alter certain provisions of our second amended and restated bylaws without obtaining stockholder approval; ● the approval of the holders of at least two-thirds of the outstanding shares of our capital stock is required to adopt, amend, or repeal our second amended and restated bylaws, unless such action is recommended by our board of directors at an annual or special meeting of shareholders; ● the approval of the holders of at least two-thirds of the outstanding shares of our capital stock is required to adopt, amend, or repeal provisions in our second amended and restated certificate of incorporation relating to (i) the amendment of the second amended and restated certificate of incorporation or 152 Table of Contents amendment of the second amended and restated bylaws, (ii) stockholder action, (iii) election and removal of directors, (iv) limitations on liability and (v) exclusive forum for proceedings; ● stockholders must provide advance notice and additional disclosures to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain voting control of our shares; and ● our board of directors is authorized to issue shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer.
If we or our contractors fail to comply with applicable regulatory requirements following approval of CNTY-101 or our other product candidates, a regulatory authority may: ● issue a warning letter, untitled letter, or Form 483, asserting that we are in violation of the law; ● request voluntary product recalls; ● seek an injunction or impose administrative, civil, or criminal penalties or monetary fines; ● suspend or withdraw regulatory approval; ● suspend any ongoing clinical trials; ● refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto); ● restrict the marketing or manufacturing of the product; ● seize or detain the product or otherwise require the withdrawal of the product from the market; ● refuse to permit the import or export of product candidates; or ● refuse to allow us to enter into supply contracts, including government contracts.
If we or our contractors fail to comply with applicable regulatory requirements following approval, if granted, of CNTY-101 or our other product candidates, a regulatory authority may: ● issue a warning letter, untitled letter, or Form 483, asserting that we are in violation of the law; ● request voluntary product recalls; ● seek an injunction or impose administrative, civil, or criminal penalties or monetary fines; ● suspend or withdraw regulatory approval; ● suspend any ongoing clinical trials; ● refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto); ● restrict the marketing or manufacturing of the product; ● seize or detain the product or otherwise require the withdrawal of the product from the market; ● refuse to permit the import or export of product candidates; or ● refuse to allow us to enter into supply contracts, including government contracts.
The market price for our common stock may be influenced by those factors discussed in this “Risk factors” section and many others, including: ● the commencement, enrollment, or results of our current and future preclinical studies and clinical trials, and the results of trials of our competitors or those of other companies in our market sector; ● regulatory approval of our product candidates, or limitations to specific label indications or patient populations for its use, or changes or delays in the regulatory review process; ● regulatory developments in the United States and foreign countries; 139 Table of Contents ● changes in the structure of healthcare payment systems, especially in light of current reforms to the United States healthcare system; ● the success or failure of our efforts to acquire, license, or develop additional product candidates; ● innovations or new products developed by us or our competitors; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments; ● manufacturing, supply or distribution delays or shortages; ● any changes to our relationship with FCDI, any manufacturers, suppliers, licensors, future collaborators, or other strategic partners; ● achievement of expected product sales and profitability; ● variations in our financial results or those of companies that are perceived to be similar to us; ● market conditions in the biopharmaceutical sector and issuance of securities analysts’ reports or recommendations; ● trading volume of our common stock; ● an inability to obtain additional funding; ● sales of our stock by insiders and stockholders; ● general economic, industry, and market conditions, or other events or factors, many of which are beyond our control; ● additions or departures of key personnel; and ● intellectual property, product liability, or other litigation against us.
The market price for our common stock may be influenced by those factors discussed in this “Risk factors” section and many others, including: ● the commencement, enrollment, or results of our current and future preclinical studies and clinical trials, and the results of trials of our competitors or those of other companies in our market sector; 148 Table of Contents ● regulatory approval of our product candidates, or limitations to specific label indications or patient populations for its use, or changes or delays in the regulatory review process; ● regulatory developments in the United States and foreign countries; ● changes in the structure of healthcare payment systems, especially in light of current reforms to the United States healthcare system; ● the success or failure of our efforts to acquire, license, or develop additional product candidates; ● innovations or new products developed by us or our competitors; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments; ● manufacturing, supply or distribution delays or shortages; ● any changes to our relationship with FCDI, any manufacturers, suppliers, licensors, future collaborators, or other strategic partners; ● achievement of expected product sales and profitability; ● variations in our financial results or those of companies that are perceived to be similar to us; ● market conditions in the biopharmaceutical sector and issuance of securities analysts’ reports or recommendations; ● trading volume of our common stock; ● an inability to obtain additional funding; ● sales of our stock by insiders and stockholders; ● general economic, industry, and market conditions, or other events or factors, many of which are beyond our control; ● additions or departures of key personnel; and ● intellectual property, product liability, or other litigation against us.
If we are successful in obtaining marketing approval from applicable regulatory authorities for CNTY-101 or any of our other product candidates, our ability to generate revenues from such product candidates will depend on our success in: ● launching commercial sales of our product candidates, whether alone or in collaboration with others; ● receiving an approved label with claims that are necessary or desirable for successful marketing, and that does not contain safety or other limitations that would impede our ability to market our product candidates; ● creating market demand for our product candidates through marketing, sales, and promotion activities; ● hiring, training, and deploying a sales force or contracting with third parties to commercialize our product candidates; ● manufacturing, either on our own or through third parties, product candidates in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; ● establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; ● creating partnerships with, or offering licenses to, third parties to promote and sell product candidates in foreign markets where we receive marketing approval; ● obtaining, maintaining, protecting, and enforcing patent and trade secret protection and regulatory exclusivity for our product candidates; 107 Table of Contents ● achieving market acceptance of our product candidates by patients, the medical community, and third-party payors; ● achieving appropriate reimbursement for our product candidates, if approved; ● effectively competing with other therapies; and ● maintaining an acceptable tolerability profile of our product candidates following launch. ​ To the extent we are not able to do any of the foregoing, our business, financial condition, results of operations, and prospects will be materially harmed.
If we are successful in obtaining marketing approval from applicable regulatory authorities for CNTY-101 or any of our other product candidates, our ability to generate revenues from such product candidates will depend on our success in: ● launching commercial sales of our product candidates, whether alone or in collaboration with others; ● receiving an approved label with claims that are necessary or desirable for successful marketing, and that does not contain safety or other limitations that would impede our ability to market our product candidates; ● creating market demand for our product candidates through marketing, sales, and promotion activities; ● hiring, training, and deploying a sales force or contracting with third parties to commercialize our product candidates; ● manufacturing, either on our own or through third parties, product candidates in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; ● establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; ● creating partnerships with, or offering licenses to, third parties to promote and sell product candidates in foreign markets where we receive marketing approval; ● obtaining, maintaining, protecting, and enforcing patent and trade secret protection and regulatory exclusivity for our product candidates; 119 Table of Contents ● achieving market acceptance of our product candidates by patients, the medical community, and third-party payors; ● achieving appropriate reimbursement for our product candidates, if approved; ● effectively competing with other therapies; and ● maintaining an acceptable tolerability profile of our product candidates following launch. ​ To the extent we are not able to do any of the foregoing, our business, financial condition, results of operations, and prospects will be materially harmed.
The clinical and commercial success of our product candidates will depend on several factors, including the following: ● timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies, and minimally efficacious dose studies in animals, where applicable, and in accordance with Good Laboratory Practices, or GLPs;; ● effective INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; ● successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or cGCPs, and GLPs; ● positive results from our ongoing, planned and future clinical programs that support a finding of safety and effectiveness and an acceptable risk-benefit profile of our product candidates in the intended populations; ● receipt of marketing approvals from applicable regulatory authorities; ● establishment of arrangements with CMOs for clinical supply and, where applicable, commercial manufacturing capabilities; ● establishment and maintenance of patent and trade secret protection, and/or regulatory exclusivity for our product candidates 87 Table of Contents ● commercial launch of our product candidates, if approved, whether alone or in collaboration with others; ● acceptance of the benefits and use of our product candidates, including method of administration, if and when approved, by patients, the medical community, and third-party payors; ● effective competition with other therapies; ● establishment and maintenance of healthcare coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; ● establishment of a physician training system and network for administration of our product candidates; ● enforcement and defense of intellectual property rights and claims; and ● maintenance of a continued acceptable safety, tolerability, and efficacy profile of our product candidates following approval.
The clinical and commercial success of our product candidates will depend on several factors, including the following: ● timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies, and minimally efficacious dose studies in animals, where applicable, and in accordance with Good Laboratory Practices, or GLPs; ● effective INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; ● successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or cGCPs, and GLPs; ● positive results from our ongoing, planned and future clinical programs that support a finding of safety and effectiveness and an acceptable risk-benefit profile of our product candidates in the intended populations; ● receipt of marketing approvals from applicable regulatory authorities; ● establishment of arrangements with CMOs for clinical supply and, where applicable, commercial manufacturing capabilities; ● establishment and maintenance of patent and trade secret protection, and/or regulatory exclusivity for our product candidates; ● commercial launch of our product candidates, if approved, whether alone or in collaboration with others; ● acceptance of the benefits and use of our product candidates, including method of administration, if and when approved, by patients, the medical community, and third-party payors; ● effective competition with other therapies; 97 Table of Contents ● establishment and maintenance of healthcare coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; ● establishment of a physician training system and network for administration of our product candidates; ● enforcement and defense of intellectual property rights and claims; and ● maintenance of a continued acceptable safety, tolerability, and efficacy profile of our product candidates following approval.
Market acceptance of our product candidates, if approved, will depend on a number of factors, including, among others: ● the prevalence and severity of any adverse side effects associated with our product candidates; ● limitations or warnings contained in the labeling approved for our product candidates by the FDA or comparable foreign regulatory authority, such as a “black box” warning; ● availability of alternative treatments, including any competitive therapies in development that could be approved or commercially launched prior to approval of our product candidates; 111 Table of Contents ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the strength of marketing and distribution support and timing of market introduction of competitive products; ● pricing; ● payor acceptance; ● the impact of any future changes to the United States healthcare system; ● the effectiveness of our sales and marketing strategies; and ● the likelihood that the FDA may require development of a REMS, as a condition of approval or post-approval or may not agree with our proposed REMS or may impose additional requirements that limit the promotion, advertising, distribution, or sales of our product candidates.
Market acceptance of our product candidates, if approved, will depend on a number of factors, including, among others: ● the prevalence and severity of any adverse side effects associated with our product candidates; ● limitations or warnings contained in the labeling approved for our product candidates by the FDA or comparable foreign regulatory authority, such as a “black box” warning; 123 Table of Contents ● availability of alternative treatments, including any competitive therapies in development that could be approved or commercially launched prior to approval of our product candidates; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the strength of marketing and distribution support and timing of market introduction of competitive products; ● pricing; ● payor acceptance; ● the impact of any future changes to the United States healthcare system; ● the effectiveness of our sales and marketing strategies; and ● the likelihood that the FDA may require development of a REMS, as a condition of approval or post-approval or may not agree with our proposed REMS or may impose additional requirements that limit the promotion, advertising, distribution, or sales of our product candidates.
An inability to continue to source product from any of these suppliers, which could be due to the impacts of global pandemics, macroeconomic factors, recent regulatory actions, or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business. 104 Table of Contents If we are required to change suppliers, or modify the components, equipment, materials, or disposables used for the manufacture of our product candidates, we may be required to change our manufacturing operations or clinical trial protocols or to provide additional data to regulatory authorities in order to use any alternative components, equipment, materials, or disposables, any of which could set back, delay, or increase the costs required to complete our clinical development and commercialization of our product candidates.
An inability to continue to source product from any of these suppliers, which could be due to the impacts of global pandemics, macroeconomic factors, recent regulatory actions, or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business. 116 Table of Contents If we are required to change suppliers, or modify the components, equipment, materials, or disposables used for the manufacture of our product candidates, we may be required to change our manufacturing operations or clinical trial protocols or to provide additional data to regulatory authorities in order to use any alternative components, equipment, materials, or disposables, any of which could set back, delay, or increase the costs required to complete our clinical development and commercialization of our product candidates.
Although certain of our employees have prior experience with clinical trials and regulatory approvals, we have not previously completed any clinical trials or submitted a BLA to the FDA, or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that CNTY-101 or our other product candidates will be successful in clinical trials or receive regulatory approval.
Although certain of our employees have prior experience with clinical trials and regulatory approvals, we have not previously completed any clinical trials or submitted a BLA to the FDA, or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that CNTY-101 or our other product candidates will be complete and be successful in clinical trials or receive regulatory approval.
These risks and uncertainties include the following: ● the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; ● patent applications may not result in any patents being issued; ● patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide any competitive advantage; 128 Table of Contents ● our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use, and sell CNTY-101 and our other product candidates; ● there may be significant pressure on the United States government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and ● countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products.
These risks and uncertainties include the following: ● the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; ● patent applications may not result in any patents being issued; ● patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide any competitive advantage; ● our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use, and sell CNTY-101 and our other product candidates; ● there may be significant pressure on the United States government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and ● countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products.
Further, if CNTY-101 or any of our other product candidates were to receive regulatory approval and we or others identify undesirable side effects caused by the product (or any other product) after the approval, a number of potentially significant negative consequences could result, including: ● regulatory authorities may request that we recall or withdraw the product from the market or may limit the approval of the product through labeling or other means; ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication or a precaution; ● we may be required to change the way the product is distributed or administered, conduct additional clinical trials, or change the labeling of the product; ● we may decide to recall or remove the product from the marketplace; ● we could be sued and/or held liable for injury caused to individuals exposed to or taking our product candidates; ● damage to the public perception of the safety of CNTY-101 or our other product candidates; and 97 Table of Contents ● our reputation may suffer.
Further, if CNTY-101 or any of our other product candidates were to receive regulatory approval and we or others identify undesirable side effects caused by the product (or any other product) after the approval, a number of potentially significant negative consequences could result, including: ● regulatory authorities may request that we recall or withdraw the product from the market or may limit the approval of the product through labeling or other means; ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication or a precaution; ● we may be required to change the way the product is distributed or administered, conduct additional clinical trials, or change the labeling of the product; 108 Table of Contents ● we may decide to recall or remove the product from the marketplace; ● we could be sued and/or held liable for injury caused to individuals exposed to or taking our product candidates; ● damage to the public perception of the safety of CNTY-101 or our other product candidates; and ● our reputation may suffer.
If we fail to develop sufficient manufacturing 106 Table of Contents capacity and experience, whether internally or with a third party, are delayed in doing so, or fail to manufacture our product candidates economically or on reasonable scale or volumes, or in accordance with cGMP, or if the cost of this scale-up is not economically feasible, our development programs and commercialization of any approved products will be materially adversely affected and we may not be able to produce our product candidates in a sufficient quantity to meet future demand and our business, financial condition, results of operations, and growth prospects may be materially adversely affected. ​ We cryogenically store our CAR-iNK and CAR-iT cells and master and working cell banks of the engineered iPSC cells at both our own manufacturing facility and at third party facilities The CAR-iNK and CAR-iT cells and the master and working cell banks of the engineered iPSC cells are stored in freezers at both third-party biorepositories and in our freezers at our manufacturing facility.
If we fail to develop sufficient manufacturing 118 Table of Contents capacity and experience, whether internally or with a third party, are delayed in doing so, or fail to manufacture our product candidates economically or on reasonable scale or volumes, or in accordance with cGMP, or if the cost of this scale-up is not economically feasible, our development programs and commercialization of any approved products will be materially adversely affected and we may not be able to produce our product candidates in a sufficient quantity to meet future demand and our business, financial condition, results of operations, and growth prospects may be materially adversely affected. ​ We cryogenically store our CAR-iNK and CAR-iT cells and master and working cell banks of the engineered iPSC cells at both our own manufacturing facility and at third party facilities The CAR-iNK and CAR-iT cells and the master and working cell banks of the engineered iPSC cells are stored in freezers at both third-party biorepositories and in our freezers at our manufacturing facility.
Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population, the number and location of clinical sites we enroll, the proximity of patients to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the inability to obtain and maintain patient consents, the risk that enrolled participants will drop out before completion, competing clinical trials, and clinicians’ patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs or therapeutic biologics that may be approved for the indications being investigated by us, and other factors, such as the COVID-19 pandemic, over which we have no control.
Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population, the number and location of clinical sites we enroll, the proximity of patients to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the inability to obtain and maintain patient consents, the risk that enrolled participants will drop out before completion, competing clinical trials, and clinicians’ patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs or therapeutic biologics that may be approved for the indications being investigated by us, and other factors, such as the COVID-19 pandemic, or future pandemics, over which we have no control.
Our or a CMO’s failure to execute on our manufacturing requirements, to do so on commercially reasonable terms and comply with cGMP could adversely affect our business in a number of ways, including: ● an inability to initiate or continue clinical trials of CNTY-101 or our other product candidates under development; ● delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates; 105 Table of Contents ● subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities; ● requirements to cease development or to recall batches of our product candidates; and ● in the event of approval to market and commercialize CNTY-101 or our other product candidates, an inability to meet commercial demands for CNTY-101 or our other product candidates.
Our or a CMO’s failure to execute on our manufacturing requirements, to do so on commercially reasonable terms and comply with cGMP could adversely affect our business in a number of ways, including: ● an inability to initiate or continue clinical trials of CNTY-101 or our other product candidates under development; ● delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates; 117 Table of Contents ● subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities; ● requirements to cease development or to recall batches of our product candidates; and ● in the event of approval to market and commercialize CNTY-101 or our other product candidates, an inability to meet commercial demands for CNTY-101 or our other product candidates.
Although we have filed patent applications with respect to CNTY-101 and other aspects of our product technology, our patent portfolio is in an earlier stage of prosecution. We do not own any issued patents related to CNTY-101 and our other product candidates.
Although we have filed patent applications with respect to CNTY-101 and other aspects of our product technology, our patent portfolio is in an earlier stage of prosecution. We do not own any issued patents related to some of our product candidates.
We anticipate that our expenses will increase substantially if, and as, we: ● continue to advance our induced pluripotent stem cells, or iPSC-derived allogeneic, cell therapy platforms; ● continue the clinical development of CNTY-101 and the preclinical and clinical development of our other product candidates; ● seek to discover and develop additional product candidates; ● establish and validate our own clinical-scale current good manufacturing practices, or cGMP, facilities; ● seek regulatory approvals for any of our other product candidates that successfully complete clinical trials; ● maintain, expand, protect, and enforce our intellectual property portfolio; ● acquire or in-license other product candidates and technologies; ● incur additional costs associated with operating as a public company, such as operational, financial, and management information systems and personnel, including personnel to support our drug development, any future commercialization efforts; and ● increase our employee headcount and related expenses to support these activities.
We anticipate that our expenses will increase substantially if, and as, we: ● continue to advance our induced pluripotent stem cells, or iPSC-derived allogeneic, cell therapy platforms; ● continue the clinical development of CNTY-101 and the preclinical and clinical development of our other product candidates; ● seek to discover and develop additional product candidates; ● establish and validate our own clinical-scale current good manufacturing practices, or cGMP, facilities; ● seek regulatory approvals for any of our other product candidates that successfully complete clinical trials; 91 Table of Contents ● maintain, expand, protect, and enforce our intellectual property portfolio; ● acquire or in-license other product candidates and technologies; ● incur additional costs associated with operating as a public company, such as operational, financial, and management information systems and personnel, including personnel to support our drug development, any future commercialization efforts; and ● increase our employee headcount and related expenses to support these activities.
Additionally, a trial that is not well-designed could be inefficient or more expensive than it otherwise would have been, or we may incorrectly estimate the costs to implement the clinical trial, which could lead to a shortfall in funding. 94 Table of Contents Interim, topline, or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
Additionally, a trial that is not well-designed could be inefficient or more expensive than it otherwise would have been, or we may incorrectly estimate the costs to implement the clinical trial, which could lead to a shortfall in funding. 105 Table of Contents Interim, topline, or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
It cannot be predicted whether, when, in what form or with what effective dates tax laws, regulations and rulings may be enacted, promulgated or issued, which could result in an increase in our or our shareholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law. 84 Table of Contents Our Option Agreement with Bayer HealthCare LLC may require us to sell certain of our product candidates, which may limit the value we could generate from our product candidates.
It cannot be predicted whether, when, in what form or with what effective dates tax laws, regulations and rulings may be enacted, promulgated or issued, which could result in an increase in our or our shareholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law. 94 Table of Contents Our Option Agreement with Bayer HealthCare LLC may require us to sell certain of our product candidates, which may limit the value we could generate from our product candidates.
If we are unable to secure or maintain patent protection with respect to our antibody technology and any proprietary products and technology we develop, our business, financial condition, results of operations, and prospects could be materially harmed.
If we are unable to secure or maintain patent protection with respect to our technology and any proprietary products and technology we develop, our business, financial condition, results of operations, and prospects could be materially harmed.
Broad market and industry factors, including potentially worsening economic conditions and other adverse effects, or developments relating to pandemics, political, regulatory, and other market conditions, may negatively affect the market price of shares of our common stock, regardless of our actual operating performance. 85 Table of Contents Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and financial condition and results of operations.
Broad market and industry factors, including potentially worsening economic conditions and other adverse effects, or developments relating to pandemics, political, regulatory, and other market conditions, may negatively affect the market price of shares of our common stock, regardless of our actual operating performance. ​ 95 Table of Contents Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and financial condition and results of operations.
Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues, the resolution of which could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement; ● whether and the extent to which our technology and processes infringe, misappropriate, or otherwise violate intellectual property of the licensor that is not subject to the licensing agreement; ● our right to sublicense patents and other intellectual property rights to third parties; ● our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of CNTY-101 and our other product candidates, and what activities satisfy those diligence obligations; ● our right to transfer or assign the license; and ● the ownership of inventions, know-how, and other intellectual property resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues, the resolution of which could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement; ● whether and the extent to which our technology and processes infringe, misappropriate, or otherwise violate intellectual property of the licensor that is not subject to the licensing agreement; ● our right to sublicense patents and other intellectual property rights to third parties; ● our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of CNTY-101 and our other product candidates, and what activities satisfy those diligence obligations; 136 Table of Contents ● our right to transfer or assign the license; and ● the ownership of inventions, know-how, and other intellectual property resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop or combination therapy, we may be unable to obtain approval of or market our product candidates. 88 Table of Contents Our business depends upon the success of our iPSC-derived allogeneic cell therapy platforms.
If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop or combination therapy, we may be unable to obtain approval of or market our product candidates. 98 Table of Contents Our business depends upon the success of our iPSC-derived allogeneic cell therapy platforms.
Moreover, the reprogramming technology licensed to us from FCDI and the gene editing technology licensed to us from Inscripta, Inc. are each licensed to us on a non-exclusive basis, and therefore third parties may obtain licenses to the same technology to compete with us. 108 Table of Contents Large pharmaceutical companies that have commercialized or are developing immunotherapies to treat cancer include AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Pfizer, and Roche/Genentech.
Moreover, the reprogramming technology licensed to us from FCDI and the gene editing technology licensed to us from Inscripta, Inc. are each licensed to us on a non-exclusive basis, and therefore third parties may obtain licenses to the same technology to compete with us. 120 Table of Contents Large pharmaceutical companies that have commercialized or are developing immunotherapies to treat cancer include AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Pfizer, and Roche/Genentech.
We may experience numerous unforeseen events during, or as a result of, any clinical trials that we conduct that could delay or prevent our ability to receive marketing approval or commercialize our product candidates. 98 Table of Contents Changes in regulatory requirements, guidance from the FDA and other regulatory authorities, or unanticipated events during our clinical trials of CNTY-101 or our other product candidates may result in changes to preclinical studies or clinical trials or additional preclinical or clinical trial requirements, which could result in increased costs to us and could delay our development timeline.
We may experience numerous unforeseen events during, or as a result of, any clinical trials that we conduct that could delay or prevent our ability to receive marketing approval or commercialize our product candidates. 110 Table of Contents Changes in regulatory requirements, guidance from the FDA and other regulatory authorities, or unanticipated events during our clinical trials of CNTY-101 or our other product candidates may result in changes to preclinical studies or clinical trials or additional preclinical or clinical trial requirements, which could result in increased costs to us and could delay our development timeline.
In the United States, we are subject to numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, governing the collection, use, disclosure, storage, transfer, protection, and disposal of health-related and other the personal and/or confidential information we and/or our collaborators utilize A failure to comply with these current or future federal, state, and international laws and regulations and industry standards relating to data privacy and security could lead to investigatory or regulatory action, private litigation or class actions that could result in exposure to civil or criminal penalties, monetary or statutory damages, attorney fee awards and/or exposure to adverse publicity that could negatively affect our operating results and business.
In the United States, we are subject to numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, governing the collection, use, disclosure, storage, transfer, protection, and disposal of health-related and other the personal and/or confidential information we and/or our collaborators utilize A failure to comply with these current or future federal, state, and international laws and regulations and industry standards relating to data privacy and security could lead to investigatory or regulatory action, private litigation or class actions that could result in exposure to civil or criminal penalties, 132 Table of Contents monetary or statutory damages, attorney fee awards and/or exposure to adverse publicity that could negatively affect our operating results and business.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, if these parties are adversely impacted by macroeconomic or other factors limiting or materially affecting their ability to carry out their contractual duties, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons, our preclinical studies and clinical trials may be repeated, extended, delayed, or terminated; we may not be able to obtain, or may be delayed in obtaining, marketing approvals for CNTY-101 and our other product candidates; we may not be able to, or may be delayed in our efforts to, successfully commercialize CNTY-101 or our other product candidates; or we or they may be subject to regulatory enforcement actions.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, if these 112 Table of Contents parties are adversely impacted by macroeconomic or other factors limiting or materially affecting their ability to carry out their contractual duties, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons, our preclinical studies and clinical trials may be repeated, extended, delayed, or terminated; we may not be able to obtain, or may be delayed in obtaining, marketing approvals for CNTY-101 and our other product candidates; we may not be able to, or may be delayed in our efforts to, successfully commercialize CNTY-101 or our other product candidates; or we or they may be subject to regulatory enforcement actions.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for our products; ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants and inability to continue clinical trials; ● initiation of investigations by regulators; 121 Table of Contents ● costs to defend the related litigation; ● a diversion of management’s time and our resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing, or promotional restrictions; ● significant negative financial impact; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize CNTY-101 or our other product candidates; and ● a decline in our stock price.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for our products; ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants and inability to continue clinical trials; ● initiation of investigations by regulators; ● costs to defend the related litigation; ● a diversion of management’s time and our resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing, or promotional restrictions; ● significant negative financial impact; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize CNTY-101 or our other product candidates; and ● a decline in our stock price.
If we, or a regulatory authority, discover(s) previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the 110 Table of Contents market or suspension of manufacturing.
If we, or a regulatory authority, discover(s) previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees with the 122 Table of Contents promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.07 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.
However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.
Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize CNTY-101 or our other product candidates and adversely affect our business, financial condition, results of operations, and prospects.
Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize CNTY-101 or our other product candidates, if approved, and adversely affect our business, financial condition, results of operations, and prospects.
Additionally, advancing novel immuno-oncology cell therapies creates significant challenges for us, including: ● developing and sustaining a manufacturing process to produce our cells on a large scale and in a cost-effective manner; ● educating medical personnel regarding the potential side-effect profile of our cells and, as the clinical program progresses, on any observed side effects with the therapy; ● unanticipated technical limitations of our CRISPR-MAD7 gene editing technology; and ● establishing sales and marketing capabilities, as well as developing a distribution network to support the commercialization of any approved products. 89 Table of Contents We must be able to overcome these challenges in order for us to successfully develop, commercialize, and manufacture our product candidates utilizing CAR-iNK and CAR-iT cells.
Additionally, advancing novel immuno-oncology and autoimmune and inflammatory cell therapies creates significant challenges for us, including: ● developing and sustaining a manufacturing process to produce our cells on a large scale and in a cost-effective manner; ● educating medical personnel regarding the potential side-effect profile of our cells and, as the clinical program progresses, on any observed side effects with the therapy; ● unanticipated technical limitations of our CRISPR-MAD7 gene editing technology; and ● establishing sales and marketing capabilities, as well as developing a distribution network to support the commercialization of any approved products. 99 Table of Contents We must be able to overcome these challenges in order for us to successfully develop, commercialize, and manufacture our product candidates utilizing CAR-iNK and CAR-iT cells.
The FDA and other comparable global regulatory authorities can delay, limit, or deny approval of a product candidate for many reasons.
The FDA and other comparable global regulatory authorities can delay, limit, or deny development or approval of a product candidate for many reasons.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. 142 Table of Contents If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. 151 Table of Contents If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
If we are unable to implement technological advancements consistent with industry standards, our operations and financial condition may be adversely affected. 90 Table of Contents Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
If we are unable to implement technological advancements consistent with industry standards, our operations and financial condition may be adversely affected. 101 Table of Contents Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or 122 Table of Contents patients’ personal data could result in significant liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our business.
Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the GDPR) and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our business.
Future growth will impose significant added responsibilities on members of management, including: ● identifying, recruiting, integrating, maintaining, and motivating additional employees; ● managing our internal development efforts effectively, including additional clinical and FDA or other comparable authority review process for CNTY-101 and our other product candidates, while complying with our contractual obligations to contractors and other third parties; and 115 Table of Contents ● improving our operational, financial, and management controls, reporting systems, and procedures.
Future growth will impose significant added responsibilities on members of management, including: ● identifying, recruiting, integrating, maintaining, and motivating additional employees; ● managing our internal development efforts effectively, including additional clinical and FDA or other comparable authority review process for CNTY-101 and our other product candidates, while complying with our contractual obligations to contractors and other third parties; and ● improving our operational, financial, and management controls, reporting systems, and procedures.
We experienced modest delays in our discovery and development activities as a result of the COVID-19 pandemic, primarily due to temporary and partial shutdowns at certain of our CROs and academic institutions that have since resumed operations, and due to governmental responses to the pandemic.
For example, we experienced modest delays in our discovery and development activities as a result of the COVID-19 pandemic, primarily due to temporary and partial shutdowns at certain of our CROs and academic institutions that have since resumed operations, and due to governmental responses to the pandemic.
Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants, and advisors, we cannot provide any assurances that all such agreements have been duly executed, and any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants, and advisors, we cannot provide any assurances that all such agreements have been duly executed, and any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and 147 Table of Contents we may not be able to obtain adequate remedies for such breaches.
In the United States, the principal decisions about reimbursement for new therapies are typically made by Centers for Medicare and Medicaid 109 Table of Contents Services, or CMS, an agency within the United States Department of Health and Human Services.
In the United States, the principal decisions about reimbursement for new therapies are typically made by Centers for Medicare and Medicaid 121 Table of Contents Services, or CMS, an agency within the United States Department of Health and Human Services.
If we are unable to prove that these patents are invalid or unenforceable or not infringed and we are not able to obtain or maintain a license on commercially reasonable terms, or at all, such third parties could potentially assert infringement claims against us, which could have a material adverse effect on the conduct of our business.
If 143 Table of Contents we are unable to prove that these patents are invalid or unenforceable or not infringed and we are not able to obtain or maintain a license on commercially reasonable terms, or at all, such third parties could potentially assert infringement claims against us, which could have a material adverse effect on the conduct of our business.
As a result of the lingering effects of the recent COVID-19 pandemic and other factors, the business and operations of our suppliers may be disrupted or delayed, and we in turn may experience disruptions or delays in our supply chain.
As a result of the lingering effects of the COVID-19 pandemic and other macroeconomic factors, the business and operations of our suppliers may be disrupted or delayed, and we in turn may experience disruptions or delays in our supply chain.
If we do not obtain meaningful patent coverage for our product candidates, their respective components, formulations, combination therapies, methods used to manufacture them, and methods of treatment, competitors may be able to erode or negate any competitive 125 Table of Contents advantage we may have, which would likely harm our business and ability to achieve profitability.
If we do not obtain meaningful patent coverage for our product candidates, their respective components, formulations, combination therapies, methods used to manufacture them, and methods of treatment, competitors may be able to erode or negate any competitive advantage we may have, which would likely harm our business and ability to achieve profitability.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. 139 Table of Contents The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
Further, the FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after they have reviewed and commented on the design for our clinical trials. 93 Table of Contents Our product development costs will increase if we experience delays in clinical testing or marketing approvals.
Further, the FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after they have reviewed and commented on the design for our clinical trials. Our product development costs will increase if we experience delays in clinical testing or marketing approvals.
Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease the commercialization of our products. Even a successful defense would require significant financial and management resources.
Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease the commercialization of our products. Even a successful defense would 130 Table of Contents require significant financial and management resources.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property 145 Table of Contents to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. ​ ​ ​ ​ ​ ​ ​ ​ 93 Table of Contents Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusion from government funded healthcare programs and imprisonment.
If any of the 128 Table of Contents physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusion from government funded healthcare programs and imprisonment.
If our sub licensors fail to comply with their obligations under their upstream license agreements, and the upstream license agreements are consequently terminated, such termination may result in the termination of our sublicenses and loss of such rights. 127 Table of Contents Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.
If our sub licensors fail to comply with their obligations under their upstream license agreements, and the upstream license agreements are consequently terminated, such termination may result in the termination of our sublicenses and loss of such rights. Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.
Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects. 136 Table of Contents Patent terms may be inadequate to protect our competitive position on CNTY-101 and our other product candidates for an adequate amount of time. Patents have a limited lifespan.
Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects. Patent terms may be inadequate to protect our competitive position on CNTY-101 and our other product candidates for an adequate amount of time. Patents have a limited lifespan.
For example, under Section 174 of the Code, in taxable years beginning after December 83 Table of Contents 31, 2021, expenses that are incurred for research and development in the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow.
For example, under Section 174 of the Code, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development in the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow.
We have optimized the protocols to produce CRISPR-MAD7 and have achieved similar cutting and HDR efficiencies compared to Cpf-1, but we don’t have as much experimental data with CRISPR-MAD7 as we do with Cpf1.
We have optimized the protocols to produce CRISPR-MAD7 and have achieved similar cutting and HDR efficiencies compared to Cpf-1, but we do not have as much experimental data with CRISPR-MAD7 as we do with Cpf1.
Even if the FDA or other regulatory agencies approve any of the licensed product candidates, Bristol-Myers Squibb may elect not to proceed with the commercialization of the resulting product in one or more countries. Under the Collaboration Agreement, Bristol-Myers Squibb paid us an upfront payment of $100 million.
Even if the FDA or other regulatory agencies approve any of the licensed 113 Table of Contents product candidates, Bristol-Myers Squibb may elect not to proceed with the commercialization of the resulting product in one or more countries. Under the Collaboration Agreement, Bristol-Myers Squibb paid us an upfront payment of $100 million.
By utilizing this licensed technology, we are currently capable of achieving fully functional iNK cells from iPSCs in approximately 30 days. The FCDI Licenses impose, and future license agreements may impose, various diligence, milestone payment, royalty, and other obligations on us.
By utilizing this licensed technology, we are currently capable of achieving fully functional iNK cells from iPSCs in approximately 30 days. 135 Table of Contents The FCDI Licenses impose, and future license agreements may impose, various diligence, milestone payment, royalty, and other obligations on us.
Utilizing CAR-iNK and CAR-iT cells represents a novel approach to immuno-oncology treatment of cancer, and we must overcome significant challenges in order to develop, commercialize, and manufacture our product candidates. We have concentrated our research and development efforts on developing CAR-iNK and CAR-iT cell therapies.
Utilizing CAR-iNK and CAR-iT cells represents a novel approach to immuno-oncology treatment of cancer and autoimmune and inflammatory diseases, and we must overcome significant challenges in order to develop, commercialize, and manufacture our product candidates. We have concentrated our research and development efforts on developing CAR-iNK and CAR-iT cell therapies.
Should any of these events occur, it could significantly harm our business, results of operations, and prospects. Our commercial success depends significantly on our ability to operate without infringing, misappropriating, or otherwise violating the patents and other intellectual property and proprietary rights of third parties.
Should any of these events occur, it could significantly harm our business, results of operations, and prospects. 141 Table of Contents Our commercial success depends significantly on our ability to operate without infringing, misappropriating, or otherwise violating the patents and other intellectual property and proprietary rights of third parties.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidates or any future product candidates. 91 Table of Contents All but one of our product candidates are in preclinical development and the risk of failure for all of our product candidates is high.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidates or any future product candidates. All but one of our product candidates are in preclinical development and the risk of failure for all of our product candidates is high.
It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions 134 Table of Contents we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
We cannot predict the breadth of claims that 135 Table of Contents may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us. For example, the U.S.
We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us. For example, the U.S.
We currently anticipate that we will retain future earnings for the development, operation, and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the terms of any future debt agreements may preclude us from paying dividends.
We currently anticipate that we will retain future earnings for the development, operation, and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the terms of any future debt 149 Table of Contents agreements may preclude us from paying dividends.
As of December 31, 2022, the existing holdings of our executive officers, directors and affiliates, represented beneficial ownership, in the aggregate, of approximately 24% of our outstanding common stock.
As of December 31, 2023, the existing holdings of our executive officers, directors and affiliates, represented beneficial ownership, in the aggregate, of approximately 24% of our outstanding common stock.
Any delay in obtaining, or inability to obtain, applicable regulatory approval will delay or harm our ability to successfully develop and commercialize CNTY-101 or our other product candidates and materially adversely affect our business, financial condition, results of operations, and growth prospects.
Any delay in obtaining, or inability to obtain, applicable regulatory authorizations or approvals will delay or harm our ability to successfully develop and commercialize CNTY-101 or our other product candidates and materially adversely affect our business, financial condition, results of operations, and growth prospects.
As a result, our investors could lose confidence in our reported financial information, the market price of our stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities.
As a result, our investors could lose confidence in our reported financial information, the 129 Table of Contents market price of our stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities.
It is possible that governmental authorities will conclude that our business practices, including any consulting and advisory board arrangements with 118 Table of Contents physicians and other healthcare providers, do not comply with current or future statutes, regulations, agency guidance, or case law involving applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental authorities will conclude that our business practices, including any consulting and advisory board arrangements with physicians and other healthcare providers, do not comply with current or future statutes, regulations, agency guidance, or case law involving applicable fraud and abuse or other healthcare laws and regulations.
The actual cost to manufacture and process our product candidates could be greater than we expect and could materially and adversely affect the commercial viability of our product candidates. 103 Table of Contents We have limited experience in the manufacture of cell-based therapies.
The actual cost to manufacture and process our product candidates could be greater than we expect and could materially and adversely affect the commercial viability of our product candidates. We have limited experience in the manufacture of cell-based therapies.
There may be third-party patents or patent 132 Table of Contents applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of CNTY-101 and our other product candidates.
There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of CNTY-101 and our other product candidates.
Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.
Accordingly, the market price of 144 Table of Contents shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.
Consequently, any assumptions you make about our future success or viability may not be as informed as they could be if we had a longer operating history. 80 Table of Contents We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We have incurred significant operating losses since our inception.
Consequently, any assumptions you make about our future success or viability may not be as informed as they could be if we had a longer operating history. We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We have incurred significant operating losses since our inception.
Even if patent applications we own or license 129 Table of Contents currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage.
Even if patent applications we own or license currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage.
Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our business, financial condition or results of operations. Risks related to our business and industry We are very early in our development efforts.
Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our business, financial condition or results of operations. 96 Table of Contents Risks related to our business and industry We are early in our development efforts.
Therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license, or market and sell CNTY-101 and our other product candidates. 131 Table of Contents Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
Therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license, or market and sell CNTY-101 and our other product candidates. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The GDPR increased our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries.
The EU GDPR and UK GDPR increased our responsibility and liability in relation to personal data that we process where such processing is subject to such laws, and we may be required to put in place additional mechanisms to ensure compliance, including as implemented by individual countries.
These products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 137 Table of Contents Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
These products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe have finished construction and the operational fit out of a 53,000 square foot cell therapy manufacturing facility on a tract of land in Branchburg, New Jersey pursuant to a lease expiring in February 2037.
Biggest changeWe also have a 53,000 square foot cell therapy manufacturing facility in Branchburg, New Jersey pursuant to a lease expiring in February 2037. We believe that our current facilities are adequate to meet our ongoing needs. ​ ​
ITEM 2. PROPERTIES Our principal executive offices are located in Philadelphia, Pennsylvania, pursuant to a short-term lease. We operate in three laboratory spaces in Philadelphia pursuant to leases that expire in December 2030, October 2031 and February 2034.
ITEM 2. PROPERTIES Our principal executive offices are located in Philadelphia, Pennsylvania. We operate in three office and laboratory spaces in Philadelphia pursuant to leases that expire in December 2025, October 2031 and March 2034.
Additionally, we lease office and laboratory space in Seattle, Washington pursuant to leases expiring in September 2030, respectively and laboratory and office space in Hamilton, Ontario, pursuant to a lease that expires in October 2025.
Additionally, we lease office and laboratory space in Seattle, Washington pursuant to leases 155 Table of Contents expiring in September 2030, respectively and laboratory and office space in Hamilton, Ontario, pursuant to a lease that expires in May 2024.
Removed
We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms. ​ ​

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeOur registration statement on Form S-1 (File No. 333- 256648) relating to the IPO was declared effective by the SEC on June 17, 2021.
Biggest changeAny future determination to pay dividends will be made at the discretion of our board of directors. Use of Proceeds from Initial Public Offering On June 22, 2021, we completed our IPO. Our registration statement on Form S-1 (File No. 333- 256648) relating to the IPO was declared effective by the SEC on June 17, 2021.
Securities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report on Form 10-K. Recent Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None. ​ ​ 146 Table of Contents ITEM 6. RESERVED
Securities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report on Form 10-K. Recent Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None. ​ ​ 157 Table of Contents ITEM 6. RESERVED
Morgan, BofA Securities, SVB Leerink and Piper Sandler acted as joint book-running managers for the IPO. As of December 31, 2022, the net proceeds from our IPO have been invested in U.S. treasury bills and corporate bonds.
Morgan, BofA Securities, SVB Leerink and Piper Sandler acted as joint book-running managers for the IPO. As of December 31, 2023, the net proceeds from our IPO have been invested in U.S. treasury bills and corporate bonds.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Market Information Our common stock is publicly traded on the Nasdaq Global Market under the symbol “IPSC.” Holders As of February 28, 2023, we had approximately 115 record holders of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Market Information Our common stock is publicly traded on the Nasdaq Global Market under the symbol “IPSC.” Holders As of February 29, 2024, we had approximately 117 record holders of our common stock.
Removed
Dividends Our ability to pay cash dividends is currently restricted by the terms of our Loan and Security Agreement with Hercules Capital, Inc., as discussed in Note 9 - “Long term debt” in the notes to our consolidated financial statements. Use of Proceeds from Initial Public Offering On June 22, 2021, we completed our IPO.
Added
Dividends We have never declared or paid any dividends on our capital or common stock. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeMoreover, if we issue debt, we may need to dedicate a substantial portion of our operating cash flow to paying principal and interest on such debt and we may need to comply with operating restrictions, such as limitations on incurring additional debt, which could impair our ability to acquire, sell or license intellectual property rights which could impede our ability to conduct our business. 156 Table of Contents Cash flows The following table summarizes our cash flows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended Year ended ​ ​ December 31, 2022 December 31, 2021 ​ ​ (in thousands) Net cash provided by (used in): ​ ​ ​ ​ ​ ​ Operating activities ​ $ 14,052 ​ $ (89,002) Investing activities ​ (13,128) ​ (298,338) Financing activities ​ 27,158 ​ 417,774 Net increase in cash, cash equivalents, and restricted cash ​ $ 28,082 ​ $ 30,434 ​ Operating activities Net cash provided by operating activities was $14.1 million, and net cash used in operating activities was $89 million for the years ended December 31, 2022 and 2021, respectively.
Biggest changeMoreover, if we issue debt, we may need to dedicate a substantial portion of our operating cash flow to paying principal and interest on such debt and we may need to comply with operating restrictions, such as limitations on incurring additional debt, which could impair our ability to acquire, sell or license intellectual property rights which could impede our ability to conduct our business.
These assumptions include: ● Fair Value of Common Stock-After our IPO in June 2021, the fair value of stock-based awards was determined on the grant date using the closing price of the our common stock.
These assumptions include: ● Fair Value of Common Stock-After our IPO in June 2021, the fair value of stock-based awards was determined on the grant date using the closing price of our common stock.
We will remain an emerging growth company until the earliest of (i) December 31, 2026, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, as amended, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700 million as of the last business day of the second fiscal quarter of such year or (iv) the date on which we have issued more than $1 billion in non-convertible debt securities during the prior three-year period.
We will remain an emerging growth company until the earliest of (i) December 31, 2026, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700 million as of the last business day of the second fiscal quarter of such year or (iv) the date on which we have issued more than $1 billion in non-convertible debt securities during the prior three-year period.
We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter of such year.
We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of the last business day of the second fiscal quarter of such year.
As such, we may take advantage of reduced disclosure and other requirements otherwise generally applicable to public companies, including: ● not being required to have our registered independent public accounting firm attest to management’s assessment of our internal control over financial reporting; ● presenting reduced disclosure about our executive compensation arrangements; ● an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; ● not being required to hold non-binding advisory votes on executive compensation or golden parachute arrangements; and 158 Table of Contents ● extended transition periods for complying with new or revised accounting standards.
As such, we may take advantage of reduced disclosure and other requirements otherwise generally applicable to public companies, including: ● not being required to have our registered independent public accounting firm attest to management’s assessment of our internal control over financial reporting; ● presenting reduced disclosure about our executive compensation arrangements; 169 Table of Contents ● an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; ● not being required to hold non-binding advisory votes on executive compensation or golden parachute arrangements; and ● extended transition periods for complying with new or revised accounting standards.
Bristol-Myers Squibb On January 7, 2022, we entered into the Research, Collaboration and License Agreement, with Bristol-Myers Squibb, or the Collaboration Agreement, to collaborate on the research, development and commercialization of iNK and iT cell programs for hematologic malignancies and solid tumors, or the Collaboration Program, and each product candidate, a Development Candidate.
License and collaboration agreements Bristol-Myers Squibb On January 7, 2022, we entered into the Research, Collaboration and License Agreement, with Bristol-Myers Squibb, or the Collaboration Agreement, to collaborate on the research, development and commercialization of iNK and iT cell programs for hematologic malignancies and solid tumors, or the Collaboration Program, and each product candidate, a Development Candidate.
Based on our current business plans and the January 2023 strategic reprioritization, we believe, our cash, cash equivalents and investments as of December 31, 2022, will be sufficient for us to fund our operating expenses and capital expenditures requirements into 2026.
Based on our current business plans and the January 2023 strategic reprioritization, we believe our cash, cash equivalents and investments as of December 31, 2023, will be sufficient for us to fund our operating expenses and capital expenditures requirements into 2026.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue is less than $100 million during the most recently completed fiscal year.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year.
The expected increase in expenses will be driven in large part by our ongoing activities, if and as we: ● continue to advance our iPSC cell therapy platforms; ● progress clinical development of CNTY-101 and continue preclinical development of our other product candidates; ● seek to discover and develop additional product candidates; ● establish and validate our own clinical-scale current good manufacturing practices, or cGMP, facilities; ● seek regulatory approvals for any of our product candidates that successfully complete clinical trials; ● maintain, expand, protect, and enforce our intellectual property portfolio; ● acquire or in-license other product candidates and technologies; 148 Table of Contents ● incur additional costs associated with operating as a public company, which will require us to add operational, financial and management information systems and personnel, including personnel to support our drug development and any future commercialization efforts; and ● increase our employee headcount and related expenses to support these activities.
The expected increase in expenses will be driven in large part by our ongoing activities, if and as we: ● continue to advance our iPSC cell therapy platforms; 159 Table of Contents ● progress clinical development of CNTY-101 and continue preclinical development of our other product candidates; ● seek to discover and develop additional product candidates; ● expand and validate our own clinical-scale current good manufacturing practices, or cGMP, facilities; ● seek regulatory approvals for any of our product candidates that successfully complete clinical trials; ● maintain, expand, protect, and enforce our intellectual property portfolio; ● continue to incur costs associated with operating as a public company; ● acquire or in-license other product candidates and technologies; ● incur additional costs associated with operating as a public company, which will require us to add operational, financial and management information systems and personnel, including personnel to support our drug development and any future commercialization efforts; and ● increase our employee headcount and related expenses to support these activities.
In January 2023, we announced a strategic internal portfolio prioritization through which, among other discovery efforts, CNTY-103, a CAR-iNK product targeting CD133 and a discovery program for hematological malignancies, was de-prioritized, allowing us to further prioritize our CNTY-102 and CNTY-107 product candidates, which we believe have a higher probability of technical success and greater market potential.
In January 2023, we announced a strategic internal portfolio prioritization through which, among other discovery efforts, CNTY-103, a CAR-iNK product targeting CD133 and a discovery program for hematological malignancies, were de-prioritized, allowing us to further prioritize our CNTY-102 and CNTY-107 product candidates, which we believe have a higher probability of technical success and greater market potential.
As of December 31, 2022, the timing and likelihood of achieving the milestones and success payments and generating future product sales are uncertain and therefore, any related payments are not included in the table above. We have commitments under operating leases for certain facilities used in our operations. Our leases have initial lease terms ranging from 5 to 16 years.
As of December 31, 2023, the timing and likelihood of achieving the milestones and success payments and generating future product sales are uncertain and therefore, any related payments are not included in the table above. We have commitments under operating leases for certain facilities used in our operations. Our leases have initial lease terms ranging from 5 to 16 years.
We also enter into agreements in the normal course of business for sponsored research, preclinical studies, contract manufacturing, and other services and products for operating purposes, which are generally cancelable upon written notice. These obligations and commitments are not included in the table above. See Note 12 to our consolidated financial statements for additional information.
We also enter into agreements in the normal course of business for sponsored research, preclinical studies, contract manufacturing, and other services and products for operating purposes, which are generally cancelable upon written notice. These obligations and commitments are not included in the table above. See Note 11 to our consolidated financial statements for additional information.
Operating expenses Research and development To date, research and development expenses have related primarily to discovery and development of our iPSC cell therapy platform technology and product candidates and acquired in-process research and development.
Operating expenses Research and development To date, research and development expenses have related primarily to the discovery and development of our iPSC cell therapy platform technology and product candidates and acquired in-process research and development.
As part of the accounting for these arrangements, we must use its judgment to determine the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price. The estimation of the stand-alone selling price may include such estimates as forecasted revenues and costs, development timelines, discount rates, and probabilities of regulatory and commercial success.
As part of the accounting for these arrangements, we must use our judgment to determine the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price. The estimation of the stand-alone selling price may include such estimates as forecasted revenues and costs, development timelines, discount rates, and probabilities of regulatory and commercial success.
As a result of the operational restructuring, lab operations in Seattle and Hamilton have been closed and research activities have been consolidated in Philadelphia.
As a result of the operational restructuring, lab operations in Seattle and Hamilton, Ontario, have been closed and research activities have been consolidated in Philadelphia.
We intend to use the proceeds from such financings to, among other uses, fund research and development of our product candidates and development programs, including our pre-clinical and clinical development of CNTY-101, CNTY-102, and CNTY-107, as well as CNTY-104 and CNTY-106 in collaboration with Bristol-Myers Squibb.
We intend to use the proceeds from such financings to, among other uses, fund research and development of our product candidates and development programs, including our preclinical and clinical development of CNTY-101, CNTY-102, and CNTY-107, as well as CNTY-104 and CNTY-106 in collaboration with Bristol-Myers Squibb.
Until such time, if ever, as we can generate significant product revenue, we expect to finance our operations with our existing cash and cash equivalents, investments, any future equity or debt financings, and upfront and milestone and royalties payments, if any, received under future licenses or collaborations.
Until such time, if ever, as we can generate significant product revenue, we expect to finance our operations with our existing cash and cash equivalents, investments, any future equity or debt financings, and upfront and milestone and royalty payments, if any, received under future licenses or collaborations.
We anticipate that our research and development expenses will increase for the foreseeable future as we expand our research and development efforts including expanding the capabilities of our iPSC cell therapy platforms, identifying product candidates, progressing preclinical studies and clinical trials, including for our first clinical 151 Table of Contents product candidate CNTY-101, seeking regulatory approval of our product candidates, and incurring costs to acquire and license technologies aligned with our goal of translating iPSCs to therapies.
We anticipate that our research and development expenses will increase for the foreseeable future as we expand our research and development efforts including expanding the capabilities of our iPSC cell therapy platforms, identifying product candidates, progressing preclinical studies and clinical trials, including for our first clinical product candidate CNTY-101, seeking regulatory approval of our product candidates, and incurring costs to acquire and license technologies aligned with our goal of translating iPSCs to therapies.
Payments under these arrangements may include non-refundable, upfront fees; reimbursement of certain costs; customer option fees for additional goods or services; payments upon the achievement of development, regulatory, and commercial milestones; sales of product at certain agreed-upon amounts; and royalties on product sales. 159 Table of Contents We recognize revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606.
Payments under these arrangements may include non-refundable, upfront fees; reimbursement of certain costs; customer option fees for additional goods or services; payments upon the achievement of development, regulatory, and commercial milestones; sales of product at certain agreed-upon amounts; and royalties on product sales. We recognize revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606.
Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, we agreed to pay to FCDI (i) an upfront payment of $10 million, (ii) a percentage of any milestone payments received by us under the Collaboration Agreement, in respect of achievement of development or regulatory milestones specific to Japan, and (iii) a percentage of all royalties received by us under the Collaboration Agreement in respect of sales of products in Japan.
Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, we agreed to pay to FCDI (i) an upfront payment of $10 million, (ii) a percentage of any milestone payments received by us 161 Table of Contents under the Collaboration Agreement, in respect of achievement of development or regulatory milestones specific to Japan, and (iii) a percentage of all royalties received by us under the Collaboration Agreement in respect of sales of products in Japan.
The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. To date, we have not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed may vary from our estimates, resulting in adjustments to expenses in future periods.
We use information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. To date, we have not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed may vary from our estimates, resulting in adjustments to expenses in future periods.
On January 7, 2022, we and FCDI entered into a letter agreement, or the Letter Agreement, which amends each of the FCDI agreements as further discussed in Note 11 to our consolidated financial statements.
On January 7, 2022, we and FCDI entered into a letter agreement, or the Letter Agreement, which amends each of the FCDI agreements as further discussed in Note 9 to our consolidated financial statements.
Third-party valuations of our common stock were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. ● Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding.
Third-party valuations of our common stock were performed in accordance with the 172 Table of Contents guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. ● Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding.
We use the simplified method to determine the expected term, which is based on the average of the time-to-vesting and the contractual life of the options. 161 Table of Contents ● Expected Volatility—Due to lack of trading history for our common stock, the expected volatility is estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a time period equal to the expected term of the stock option grants.
We use the simplified method to determine the expected term, which is based on the average of the time-to-vesting and the contractual life of the options. ● Expected Volatility—Due to lack of trading history for our common stock, the expected volatility is estimated based on the average historical volatilities of common stock of comparable publicly traded entities over a time period equal to the expected term of the stock option grants.
The increase in our interest income was due to higher interest rates earned on average balances of cash, cash equivalents and investments. 154 Table of Contents Liquidity, capital resources, and capital requirements Sources of liquidity To date, we have funded our operations from the issuance and sale of our equity securities, debt financing and collaboration revenues.
The increase in our interest income was due to higher interest rates earned on average balances of cash, cash equivalents and investments. Liquidity, capital resources, and capital requirements Sources of liquidity To date, we have funded our operations from the issuance and sale of our equity securities, debt financing and collaboration revenues.
If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of us or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received.
If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of us or the licensee, such as regulatory approvals, are not considered probable of 171 Table of Contents being achieved until those approvals are received.
Following Bristol-Myers Squibb’s exercise of the License Option, we will be responsible for performing IND-enabling studies, supporting Bristol-Myers Squibb’s preparation and submission of an IND, and manufacturing of clinical supplies until completion of a proof of concept clinical trial.
Following Bristol-Myers Squibb’s exercise of the License Option, we will be responsible for performing IND- 160 Table of Contents enabling studies, supporting Bristol-Myers Squibb’s preparation and submission of an IND, and manufacturing of clinical supplies until completion of a proof of concept clinical trial.
For each 150 Table of Contents Licensed Program, Bristol-Myers Squibb will pay up to $235 million in milestone payments upon the first achievement of certain development and regulatory milestones and will pay up to $500 million per Licensed Product in net sales-based milestone payments.
For each Licensed Program, Bristol-Myers Squibb will pay up to $235 million in milestone payments upon the first achievement of certain development and regulatory milestones and will pay up to $500 million per Licensed Product in net sales-based milestone payments.
Any such adjustments are recorded on a cumulative catch-up basis in the statements of operations in the period of adjustment. 160 Table of Contents ​ Research and development expenses We record research and development costs in the periods in which they are incurred.
Any such adjustments are recorded on a cumulative catch-up basis in the statements of operations in the period of adjustment. ​ Research and development expenses We record research and development costs in the periods in which they are incurred.
We recognize revenue over the expected performance period under this agreement. We expect that our revenue for the next several years will be derived primarily from this agreement and any additional collaborations that we may enter into in the future. To date, we have not received any royalties under any of our existing collaboration agreements.
We expect that our revenue for the next several years will be derived primarily from this agreement and any additional collaborations that we may enter into in the future. To date, we have not received any royalties under any of our existing collaboration agreements.
The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements.
We expense costs for our clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements.
All of our programs are currently in the development stage, and we do not have any products approved for sale. Since our inception, we have incurred net losses each year. We had an accumulated deficit of $519.1 million as of December 31, 2022.
All of our programs are currently in the development stage, and we do not have any products approved for sale. Since our inception, we have incurred net losses each year. We had an accumulated deficit of $655.9 million as of December 31, 2023.
Our future capital requirements will depend on many factors, including: ● the scope, timing, progress, costs, and results of discovery, preclinical development, and clinical trials for our current and future product candidates; 155 Table of Contents ● the number of clinical trials required for regulatory approval of our current and future product candidates; ● the costs, timing, and outcome of regulatory review of any of our current and future product candidates; ● the cost of manufacturing clinical and commercial supplies of our current and future product candidates; ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval; ● the costs and timing of preparing, filing, and prosecuting patent applications, obtaining, maintaining, protecting, and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon, misappropriating, or violating their intellectual property rights; ● our ability to maintain existing, and establish new, strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● expenses to attract, hire and retain, skilled personnel; ● the costs of operating as a public company; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invest in businesses, products, and technologies.
Our future capital requirements will depend on many factors, including: ● the scope, timing, progress, costs, and results of discovery, preclinical development, and clinical trials for our current and future product candidates; ● the number of clinical trials required for regulatory approval of our current and future product candidates; ● the costs, timing, and outcome of regulatory review of any of our current and future product candidates; ● the cost of manufacturing clinical and commercial supplies of our current and future product candidates; ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval; ● the costs and timing of preparing, filing, and prosecuting patent applications, obtaining, maintaining, protecting, and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon, misappropriating, or violating their intellectual property rights; ● our ability to maintain existing, and establish new, strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● expenses to attract, hire and retain, skilled personnel; ● costs of operating as a public company; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invest in businesses, products, and technologies. 167 Table of Contents Until and unless we can generate substantial product revenue, we expect to finance our cash needs through the proceeds from a combination of equity offerings and debt financings, and potentially through additional license and development agreements or strategic partnerships or collaborations with third parties.
We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an accumulated deficit of $519.1 million as of December 31, 2022.
We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an accumulated deficit of $655.9 million as of December 31, 2023.
In-process research and development As a direct result of the execution of the Collaboration Agreement with Bristol-Myers Squibb, we incurred $10 million in fees to amend the FCDI agreement to gain access to the territory rights of Japan. See Note 11 to our consolidated financial statements.
In-process research and development As a direct result of the execution of the Collaboration Agreement with Bristol-Myers Squibb, we incurred $10 million in fees to amend the FCDI agreement to gain access to the territory rights of Japan in 2022. See Note 9 to our consolidated financial statements. We incurred $5.0 million in license fees to FCDI in 2023.
Net cash provided by operating activities during the year ended December 31, 2022 consisted primarily of an increase in deferred revenues of $118 million, an increase in accrued expenses of $4 million, an increase in operating lease liability of $5.3 million, and an increase of non-cash charges of $20.9 million.
Net cash provided by operating activities during the year ended December 31, 2022 consisted primarily of an increase in deferred revenues of $118.0 million from our collaboration agreement with Bristol-Myers Squibb, an increase in accrued expenses of $4.0 million, an increase in operating lease liability of $5.3 million, and an increase of non-cash charges of $20.9 million.
Since our inception, we have raised approximately $591 million in net proceeds from the sales of our equity securities. As of December 31, 2022, we had cash, and cash equivalents of $84.3 million and investments of $283.1 million.
Since our inception, we have raised approximately $591 million in net proceeds from the sales of our equity securities. As of December 31, 2023, we had cash, and cash equivalents of $47.3 million and investments of $214.5 million.
Cash used in investing activities for the year ended December 31, 2022, was $13 million, which consisted primarily of net purchases of investments of $254 million, and purchases of property and equipment of $30.6 million, which was partially offset by net sales of fixed maturity securities of $271.5 million.
Cash provided by investing activities for the year ended December 31, 2023 consisted primarily of the sale of fixed maturity securities of $283.9 million, which was partially offset by purchases of fixed maturity securities of $212.7 million and acquisition of property and equipment of $13.7 million. 168 Table of Contents Cash (used in) investing activities for the year ended December 31, 2022 was ($13.1) million which consisted primarily of net purchases of investments of $254 million, and purchases of property and equipment of $30.6 million, which was partially offset by net sales of fixed maturity securities of $271.5 million.
We have created a comprehensive allogeneic cell therapy platform that includes industry-leading induced pluripotent stem cells, or iPSCs, differentiation know-how to generate immune effector cells from iPSCs, or iPSC- derived cells, clustered regularly interspaced short palindromic repeats, or CRISPR, mediated precision gene editing that allows us to incorporate multiple transgenes and remove target genes intended to optimize cell product performance, sophisticated protein engineering capabilities to develop proprietary next generation chimeric antigen receptors, or CARs, our proprietary Allo-EvasionTM technology intended to prevent rejection of our cell products by the host immune system, and cutting edge manufacturing capabilities intended to minimize product development and supply risk.
We have created a comprehensive, genetically engineered allogeneic cell therapy platform that includes: ​ • Industry-leading induced pluripotent stem cells, or iPSCs and differentiated know-how to generate immune effector cells from iPSCs, or iPSC- derived cells; ​ • Clustered regularly interspaced short palindromic repeats, or CRISPR, mediated precision gene editing that allows us to incorporate multiple transgenes and remove target genes intended to optimize cell product performance; ​ • Sophisticated protein engineering capabilities to develop proprietary next generation chimeric antigen receptors, or CARs; ​ • Our proprietary Allo-Evasion TM technology intended to prevent rejection of our cell products by the host immune system; and ​ • Cutting edge manufacturing capabilities intended to minimize product development and supply risk. ​ We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies.
See Note 12 to our consolidated financial statements. Components of operating results Collaboration Revenue We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for the foreseeable future. Our revenues to date have been generated through our collaboration, option and license agreement with Bristol-Myers Squibb.
Components of operating results Collaboration Revenue We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for the foreseeable future. Our revenues to date have been generated through our collaboration, option and license agreement with Bristol-Myers Squibb. We recognize revenue over the expected performance period under this agreement.
The Differentiation License, as amended, provides us with an exclusive license under certain patents and know-how related to human iPSC consisting of cells that are or are modifications of NK cells, T cells, dendritic cells and macrophages derived from human iPSC.
The Differentiation License, as amended, provides us with an exclusive license under certain patents and know-how related to human iPSC consisting of cells that are or are modifications of NK cells, T cells, dendritic cells and macrophages derived from human iPSC. In consideration for the Differentiation License, FCDI received 2,980,803 shares of common stock in connection with the Reorganization.
The Reprogramming License, as amended, provides us with a non-exclusive license under certain 149 Table of Contents patents and know- how related to the reprogramming of human somatic cells to iPSCs and provide us access to iPSC lines for clinical use.
Also on September 18, 2018, we entered into the non-exclusive license, or the Reprogramming License, with FCDI. The Reprogramming License, as amended, provides us with a non-exclusive license under certain patents and know-how related to the reprogramming of human somatic cells to iPSCs and provide us access to iPSC lines for clinical use.
We determined the common stock purchase represented a premium of $7.82 per share, or $23.2 million in the aggregate, and the remaining $26.8 million was recorded as issuance of common stock in stockholders’ equity. iCELL and Distributed Bio We also have entered into a sublicense agreement with iCELL Inc. and a master services agreement with Distributed Bio, Inc.
We determined the common stock purchase represented a premium of $7.82 per share, or $23.2 million in the aggregate, and the remaining $26.8 million was recorded as issuance of common stock in stockholders’ equity.
Financing activities Cash provided by financing activities was $27.2 million and $417.8 million for the years ended December 31, 2022 and 2021, respectively. Cash provided by financing activities for the year ended December 31, 2022 consisted primarily of proceeds from issuance of shares to Bristol-Myers Squibb for $26.8 million, and proceeds from issuance of common stock of $0.3 million.
Cash provided by financing activities for the year ended December 31, 2022 consisted primarily of proceeds from issuance of shares to Bristol-Myers Squibb for $26.8 million, and proceeds from issuance of common stock of $0.3 million from equity incentive plans pursuant to the exercise of employee stock options.
The comparable companies are chosen based on their size, stage in the product development cycle, and area of specialty. We will continue to apply this process until sufficient historical information regarding the volatility of our own stock price becomes available. ● Risk-Free Interest Rate—The risk-free interest rate is based on the U.S.
The comparable companies are chosen based on their size, stage in the product development cycle, and area of specialty. Starting in June of 2023, we had sufficient historical information regarding stock trading history, and started to use our own stock volatility. ● Risk-Free Interest Rate—The risk-free interest rate is based on the U.S.
Under the Reprogramming License, we are required to make certain developmental and regulatory milestone payments as well as royalty payments upon commercialization in the low single digits. The potential development and regulatory milestone payments to be paid by us to FCDI are approximately $6 million per licensed product.
Under the Reprogramming License, we are required to make certain developmental and regulatory milestone payments as well as royalty payments upon commercialization in the low single digits.
As a direct result of the execution of the Collaboration Agreement with Bristol-Myers Squibb, the Company incurred $10 million in fees to amend the FCDI agreement to gain access to the territory rights of Japan. See Note 11 to our consolidated financial statements.
In 2022, the $10.0 million expense was a direct result of the execution of the Collaboration Agreement with Bristol-Myers Squibb, we incurred $10.0 million in fees to amend the FCDI agreement to gain access to the territory rights of Japan.
While our significant accounting policies are described in more detail in the notes to our audited consolidated financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
While our significant accounting policies are described in more detail in the notes to our audited consolidated financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. 170 Table of Contents Collaboration Revenue We may enter into collaboration and licensing agreements with strategic partners for research and development, manufacturing, and commercialization of its product candidates.
We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
We anticipate that we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
Research and development expenses consist of personnel-related costs, including salaries, and benefits, stock compensation expense, external research and development expenses incurred under arrangements with third parties, laboratory supplies, costs to acquire and license technologies facility and other allocated expenses, including rent, depreciation, and allocated overhead costs, and other research and development expenses.
Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid expenses until the goods or services are received. 162 Table of Contents Research and development expenses consist of personnel-related costs, including salaries, and benefits, stock compensation expense, external research and development expenses incurred under arrangements with third parties, laboratory supplies, costs to acquire and license technologies facility and other allocated expenses, including rent, depreciation, and allocated overhead costs, and other research and development expenses.
The non-cash charges of $20.9 million consisted primarily of $10.7 million of stock-based compensation expense, depreciation expense of $8.4 million, and operating lease expense of $1.6 million.
The non-cash charges of $20.9 million consisted primarily of $10.7 million of stock-based compensation expense, depreciation expense of $8.4 million, and operating lease expense of $1.6 million. This increase was partially offset by our net loss of $130.9 million and net cash outflows from decreases in our accounts payable of $4.8 million.
Research and development expenses The following table summarizes the components of our research and development expenses for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Year Ended ​ ​ ​ ​ ​ December 31, 2022 ​ December 31, 2021 ​ Change ​ ​ ​ (in thousands) Personnel and related costs ​ $ 42,901 $ 24,651 $ 18,250 Facility and other allocated costs ​ 16,759 ​ 8,780 ​ 7,979 Research and laboratory ​ 28,455 ​ 20,747 ​ 7,708 Collaborations ​ 5,415 ​ 16,669 ​ (11,254) Consulting ​ 2,697 ​ 2,796 ​ (99) Other ​ 946 ​ 2,005 ​ (1,059) Total research and development expense ​ $ 97,173 ​ $ 75,648 ​ $ 21,525 ​ 153 Table of Contents Research and development expenses were $97.2 million and $75.6 million for the years ended December 31, 2022 and 2021, respectively.
Research and development expenses The following table summarizes the components of our research and development expenses for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Year Ended ​ ​ ​ ​ ​ December 31, 2023 ​ December 31, 2022 ​ Change ​ ​ ​ (in thousands) Personnel and related costs ​ $ 41,826 $ 42,901 $ (1,075) Facility and other allocated costs ​ 24,411 ​ 16,759 ​ 7,652 Research and laboratory ​ 23,816 ​ 28,455 ​ (4,639) Collaborations ​ 255 ​ 5,415 ​ (5,160) Consulting ​ 1,239 ​ 2,697 ​ (1,458) Other ​ 1,163 ​ 946 ​ 217 Total research and development expense ​ $ 92,710 ​ $ 97,173 ​ $ (4,463) ​ Research and development expenses were $92.7 million and $97.2 million for the years ended December 31, 2023 and 2022, respectively.
Our vision is to become a premier fully integrated biotechnology company by developing and ultimately commercializing off-the-shelf allogeneic cell therapies that dramatically and positively transform the lives of patients suffering from life-threatening cancers. To achieve our vision, we have assembled a world-class team whose members collectively have decades of experience in cell therapy and drug development, manufacturing, and commercialization.
We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of treatment. Our vision is to become a premier fully integrated biotechnology company by developing and ultimately commercializing off-the-shelf allogeneic cell therapies that dramatically and positively transform the lives of patients suffering from life-threatening cancers.
No sales have been made under the Sales Agreement since its inception. ​ Future funding requirements We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting preclinical studies and clinical trials, developing new product candidates, establishing internal and external manufacturing capabilities, and funding our operations generally.
In the first quarter of 2024, 4,084,502 shares of common stock have been issued and sold pursuant to the Sales 166 Table of Contents Agreement at a weighted-average price of $4.50 per share, resulting in approximately $18.4 million in gross proceeds. ​ Future funding requirements We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting preclinical studies and clinical trials, developing new product candidates, establishing internal and external manufacturing capabilities, and funding our operations generally.
Included in our accumulated deficit, as noted above, is a non-cash expense of $225.9 million related to the fair value of the in-process research and development of Prior Century. In August 2022, the FDA notified us that our ELiPSE-1 clinical trial may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies.
As of December 31, 2023, we had cash and cash equivalents of $47.3 million and investments of $214.5 million In August 2022, the FDA notified us that our ELiPSE-1 clinical trial may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies.
Results of operations Comparison of the years ended December 31, 2022 and 2021 The following table summarizes our results of operations for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Year Ended ​ ​ ​ ​ ​ December 31, 2022 ​ December 31, 2021 ​ Change ​ ​ (in thousands) Collaboration revenue ​ $ 5,199 ​ $ — ​ $ 5,199 Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ ​ 97,173 ​ 75,648 ​ 21,525 General and administrative ​ 31,857 ​ 19,235 ​ 12,622 Write off of in-process research and development asset ​ 10,000 ​ — ​ 10,000 Total operating expenses ​ 139,030 ​ 94,883 ​ 44,147 Loss from operations ​ (133,831) ​ (94,883) ​ (38,948) Other income (expense): ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest expense ​ (1,430) ​ (1,275) ​ (155) Other income, net ​ 4,420 ​ 377 ​ 4,043 Total other income (expense) ​ ​ 2,990 ​ ​ (898) ​ ​ 3,888 Loss before provision for income taxes ​ ​ (130,841) ​ ​ (95,781) ​ ​ (35,060) Provision for income taxes ​ ​ (91) ​ ​ (43) ​ ​ (48) Net loss ​ $ (130,932) ​ $ (95,824) ​ $ (35,108) ​ Collaboration revenue For the year ended December 31, 2022, we recognized revenue of $5.2 million under our collaboration agreement with Bristol-Myers Squibb.
Results of operations Comparison of the years ended December 31, 2023 and 2022 The following table summarizes our results of operations for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Year Ended ​ ​ ​ ​ ​ December 31, 2023 ​ December 31, 2022 ​ Change ​ ​ (in thousands) Collaboration revenue ​ $ 2,235 ​ $ 5,199 ​ $ (2,964) Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ ​ 92,710 ​ 97,173 ​ (4,463) General and administrative ​ 34,706 ​ 31,857 ​ 2,849 In-process research and development asset ​ 5,000 ​ 10,000 ​ (5,000) Impairment of long-lived assets ​ ​ 16,365 ​ ​ — ​ ​ 16,365 Total operating expenses ​ 148,781 ​ 139,030 ​ 9,751 Loss from operations ​ (146,546) ​ (133,831) ​ (12,715) Other income (expense): ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest expense ​ (540) ​ (1,430) ​ 890 Interest income ​ ​ 12,677 ​ ​ 4,420 ​ ​ 8,257 Other expense ​ (383) ​ — ​ (383) Total other income (expense) ​ ​ 11,754 ​ ​ 2,990 ​ ​ 8,764 Loss before provision for income taxes ​ ​ (134,792) ​ ​ (130,841) ​ ​ (3,951) Provision for income taxes ​ ​ (1,881) ​ ​ (91) ​ ​ (1,790) Net loss ​ $ (136,673) ​ $ (130,932) ​ $ (5,741) ​ 164 Table of Contents Collaboration revenue For the year ended December 31, 2023 and 2022, we recognized revenue of $2.2 and $5.2 million under our collaboration agreement with Bristol-Myers Squibb, respectively.
The non-cash charges of $9.6 million consisted primarily of $3.7 million for depreciation expense, stock-based compensation expense of $4.7 million, and operating lease expense of $0.8 million. Investing activities Cash used in investing activities was $13.1 million and $298.3 million for the years ended December 31, 2022 and 2021, respectively.
Net cash (used in) operating activities during the year ended December 31, 2023 consisted primarily of a net loss of $136.7 million. The non-cash charges of $38.9 million consisted primarily of $13.0 million for depreciation, stock-based compensation expense of $14.6 million, and impairment of long lived assets of $16.4 million.
Payment herein subject to variable rate debt have been estimated . Other than as disclosed in the table above, the payment obligations under our license, collaboration, and acquisition agreements as of December 31, 2022 are contingent upon future events such as our achievement of pre- specified development, regulatory, and commercial milestones, or royalties on net product sales.
Contractual obligations and commitments The following table summarizes our significant contractual obligations and commitments as of December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Payments Due by Period ​ ​ 1 Year ​ 1 to 3 Years ​ 3 to 5 Years ​ More than 5 Years ​ Total ​ ​ (in thousands) Operating leases $ 7,811 $ 16,812 $ 16,876 $ 44,098 $ 85,597 ​ Other than as disclosed in the table above, the payment obligations under our license, collaboration, and acquisition agreements as of December 31, 2023 are contingent upon future events such as our achievement of pre-specified development, regulatory, and commercial milestones, or royalties on net product sales.
During the years ended December 31, 2022 and 2021, we made payments of $5.1 million and $16.2 million and incurred research and development expenses of $4.9 million and $16.7 million, and legal fees of $0.2 million and $0.1 million, respectively, related to the FCDI agreements, recorded within general and administrative expenses in its consolidated statements of operations and comprehensive loss.
In addition, we paid FCDI a $1.0 million milestone fee pursuant to the Autoimmune License for filing of the IND for SLE for CNTY-101. ​ During the years ended December 31, 2023 and 2022, we made payments of $5.2 million and $15.1 million and incurred research and development expenses of $0.0 and $4.9 million, in-process research and development expenses of $5.0 million and $10.0 million and legal fees of $0.2 million and $0.2 million, respectively, related to the FCDI agreements.
In addition, market volatility resulting from the macroeconomic factors such as inflationary pressures, recent liquidity constraints, failures and instability in U.S. and international financial banking systems , political unrest and hostilities, war or other factors could adversely impact our ability to access capital as and when needed.
Financing may not be available in sufficient amounts or on reasonable terms. In addition, market volatility resulting from the effects of the COVID-19 pandemic, inflationary pressures, disruptions of financial institutions, political unrest and hostilities, war or other factors could adversely impact our ability to access capital as and when needed.
Interest expense Interest expense relates to interest incurred on the Loan Agreement we entered into with Hercules Capital, Inc., or Hercules, in 2020, as well as amortization of the related deferred financing cost. See Note 9 to our consolidated financial statements. Other income, net Interest income, net consists of interest earned on our cash, cash equivalents and investment balances.
We incurred $16.4 million in impairment during the year ended December 31, 2023. ​ Interest expense Interest expense relates to interest incurred on the Loan Agreement we entered into with Hercules Capital, Inc., or Hercules, in 2020, as well as amortization of the related deferred financing cost. The loan was repaid in full in May 2023.
Other income, net Other income, net consisted of interest income was $4.4 million and $0.4 million for the years ended December 31, 2022 and 2021, respectively, which included interest earned on our cash, cash equivalents, and investment balances.
On May 1, 2023, we repaid the loan in its entirety and thus expect our interest expenses to decrease accordingly in subsequent periods. Interest income Interest income was $12.7 million and $4.4 million for the years ended December 31, 2023 and 2022, respectively, which related to interest earned on our cash, cash equivalents, and investment balances.
There was no in-process research and development expenses for the year ended December 31, 2021. ​ Interest expense Interest expense was $1.4 million and $1.3 million for the years ended December 31, 2022 and 2021, respectively, which related to our Loan Agreement with Hercules.
We evaluated its long-lived assets for recoverability due to changes in circumstances that indicated that the carry amounts may not be recoverable. ​ Interest expense Interest expense was $0.5 million and $1.4 million for the years ended December 31, 2023 and 2022, respectively, which related to our Loan Agreement with Hercules.
The decline was due to less in process development work in 2022 as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply for us, and ● a decrease in other expenses of $1.0 million General and administrative expenses General and administrative expenses were $31.9 million and $19.2 million for the years ended December 31, 2022 and 2021, respectively.
The decline was due to in process development work being completed in 2022 as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply for us; ● a decrease in consulting of $1.5 million which was primarily due to reduced reliance on consultants year over year; and ● these decreases were offset by an increase of $7.7 million of facility and other allocated costs, including an increase in depreciation expense of $4.8 million, an increase in rent of $0.7 million and an increase in facility services and supplies of $2.2 million as a result of our geographic footprint for office and lab space.
Subsequent to the conversion of the LLC Entity to a C-Corp on February 25, 2021, we have incurred losses and recorded a full valuation allowance on all of our net deferred tax assets.
See Note 8 to our consolidated financial statements. Interest income Interest income consists of interest earned on our cash, cash equivalents and investment balances. 163 Table of Contents Income taxes We have incurred losses and recorded a full valuation allowance on all of our net deferred tax assets.
Upon completion of this conversion, Prior Century, whose only significant asset was its equity investment in LLC, merged with the C corporation, and in connection therewith the C corporation changed its name to “Century Therapeutics, Inc.” We refer to these transactions as the 2021 Reorganization. 147 Table of Contents Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates and preparing to initiate and conduct clinical trials, undertaking preclinical studies and in-licensing intellectual property.
To achieve our vision, we have assembled a world-class team whose members collectively have decades of experience in cell therapy and drug development, manufacturing, and commercialization. ​ 158 Table of Contents Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, conducting our ELiPSE-1 clinical trial, undertaking preclinical studies and in-licensing intellectual property.
As of December 31, 2022 and 2021, we recorded $91 thousand and $43 thousand, respectively, in provisions for income taxes related to our subsidiary Century Therapeutics Canada ULC in the accompanying consolidated financial statements.
For the year ended December 31, 2023, we recorded $1.9 million in provisions for income taxes in the accompanying consolidated financial statements.
As of December 31, 2022 and 2021, there was $0 and $2.4 million in accounts payable related to the FCDI agreements on the consolidated balance sheets. From inception of the FCDI Collaboration Agreement through December 31, 2022, we incurred $36.1 million of expenses under the FCDI Collaboration Agreement.
From inception of the FCDI Collaboration Agreement through December 31, 2023, we incurred $36.4 million of expenses under the FCDI Collaboration Agreement. iCell and Distributed Bio We also have entered into a sublicense agreement with iCell Inc. and a master services agreement with Distributed Bio, Inc. See Note 11 to our consolidated financial statements.
Removed
Overview We are an innovative biotechnology company developing transformative allogeneic cell therapies to create products for the treatment of both solid tumor and hematological malignancies with significant unmet medical need.
Added
Overview We are an innovative biotechnology company harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory diseases that we believe will allow us to overcome the limitations of first-generation cell therapies.
Removed
We were formed in 2018 as Century Therapeutics, Inc., or Prior Century. In 2019, in connection with our investment from Bayer Healthcare LLC, or Bayer, Prior Century contributed substantially all of its operating assets and cash to a newly formed entity, Century Therapeutics, LLC, or the LLC Entity. We refer to this transaction as the 2019 Reorganization.
Added
In November 2023, we announced preliminary clinical data from a case study of a patient participating in the ELiPSE-1 clinical trial.
Removed
The 2019 Reorganization was accounted for as an asset acquisition under US Generally Accepted Accounting Principles, and as a result we recorded a one-time non-cash charge in the amount of $225.9 million which represented the fair value of the contributed in-process research and development, or IPR&D, of Prior Century.
Added
The patient, who received four prior lines of therapy, completed four 28-day cycles of CNTY-101 at the 100 million cell does level (Dose Level 1), the first two of which were administered following lymphodepletion while the most recent two were administered without lymphodepletion. CNTY-101 was well tolerated, with no measurable functional pre-existing or induced anti-drug-antibodies observed.
Removed
The IPR&D asset acquired was Prior Century’s comprehensive allogeneic cell therapy platform. Until February 2021, our business was operated through the LLC Entity. In February 2021, in connection with the sale of 24,721,999 shares of our Series C preferred stock, or the Series C Financing, the LLC Entity converted from a Delaware limited liability company to a Delaware C corporation.
Added
Pharmacokinetic measurements demonstrated that CNTY-101 cells were detected after each infusion with comparable kinetics, with a limited duration in circulation.
Removed
As of December 31, 2022, we had cash and cash equivalents of $84.3 million and investments of $283.1 million.
Added
The patient achieved a complete response that was ongoing as of five months following their first CNTY-101 infusion . ​ In addition, we announced on December 6, 2023 that we were notified by FDA that the Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe SLE who have failed at least two standard immunosuppressive therapies.
Removed
While the COVID-19 pandemic has stabilized within many global regions, it may cyclically continue to adversely affect our business, financial condition and results of operations.
Added
We plan to initiate the CNTY-101 CALiPSO-1 trial in SLE in the first half of 2024, with initial data expected by the end of 2024.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeWe have established a redundant operating account with a major U.S. banking institution. ​ ​ Effects of Inflation Inflation generally affects us by increasing our cost of labor and laboratory consumables. We believe that inflation has not had a material effect on our financial statements. ​ ​ ​ ​ ​ 162 Table of Contents
Biggest changeWe have established a redundant operating account with a major U.S. banking institution. ​ Banking Instability Future disruptions of financial institutions where we bank or have credit arrangements, or disruptions of the financial service industry in general, could adversely affect our ability to access our cash and cash equivalents. ​ Effects of Inflation Inflation generally affects us by increasing our cost of labor and laboratory consumables.
Interest rate and liquidity risk We had cash, cash equivalents, and restricted cash of $86.2 million as of December 31, 2022, which consisted of bank deposits and money market funds. We also had investments of $283.1 million as of December 31, 2022.
Interest rate and liquidity risk We had cash, cash equivalents, and restricted cash of $49.3 million as of December 31, 2023, which consisted of bank deposits and money market funds. We also had investments of $214.5 million as of December 31, 2023.
Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the low risk profile of the instruments in our portfolio, a change in market interest rates would not have a material impact on our financial condition and/or results of operations.
However, because of the low risk profile of the instruments in our portfolio, a change in market interest rates would not have a material impact on our financial condition and/or results of operations . ​ In addition, we are subject to liquidity risk.
At the time the FDIC was appointed receiver, we had deposit, sweep and other accounts at SVB, which represented less than 1% of our total cash, cash equivalents, restricted cash and investments.
In early 2023, several financial institutions closed and were taken in receivership by the Federal Deposit Insurance Corporation, or FDIC, including Silicon Valley Bank, or SVB. At the time the FDIC was appointed receiver, we had deposit, sweep and other accounts at SVB, which represented less than 1% of our total cash, cash equivalents, restricted cash and investments.
Removed
Additionally, we had the $10.0 million borrowing related to the Loan Agreement in September 2020 with a floating interest rate per annum (based on a year of 360 days) equal to (i) the sum of (a) the greater of 6.30% plus (b) the prime rate as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, or (ii) 9.55%.
Added
Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates.
Removed
We are therefore exposed to changes in variable United States interest rates on borrowings under our Loan Agreement. A hypothetical 1% increase in interest rates would not result in a material impact to our business. ​ In addition, we are subject to liquidity risk.
Added
We believe that inflation has not had a material effect on our financial statements. ​ ​ ​ 173 Table of Contents ​ ​
Removed
On March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver.

Other IPSC 10-K year-over-year comparisons