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

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Paragraph-level year-over-year comparison of MiNK 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.

+264 added−294 removedSource: 10-K (2024-03-21) vs 10-K (2023-03-24)

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

264 paragraphs added · 294 removed · 217 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

65 edited+17 added−32 removed176 unchanged
Biggest changeWe believe that allogeneic iNKT cells exhibit highly adaptable properties for broad therapeutic development, and we plan to achieve our goal by executing a strategy with the following key elements: • Advance agenT-797, native iNKT cells, in cancer, including solid tumors, as monotherapy and in combination with checkpoint antibodies.
Biggest changeWe believe that allogeneic iNKT cells exhibit highly adaptable properties for broad therapeutic development, and we plan to achieve our goal by executing a strategy with the following key elements: • Advance agenT-797, native iNKT cells, in cancer, including solid tumors, as monotherapy and in combination with checkpoint antibodies. • Validate broad applicability of iNKT cells through our opportunistic development of agenT-797 in severe respiratory distress, and other immune related diseases such as GvHD. • Apply our proprietary technologies to build a broad pipeline of engineered iNKT cells, starting with MiNK-215, FAP-CAR-iNKT, with IND enabling activities actively underway. • Continue to scale up our in-house manufacturing processes and build our capability to cost-efficiently optimize speed, control, flexibility and scalability . • Selectively explore additional strategic partnerships that can enhance the potential of our iNKT cell product candidates and combination therapies.
We entered into an Intellectual Property Assignment and License Agreement with Agenus (the “Agenus License Agreement”) in September 2021, which provides us with access to Agenus therapeutic candidates and adjuvants for use in our development activities, subject to rights retained by Agenus.
In September 2021,we entered into an Intellectual Property Assignment and License Agreement with Agenus (the “Agenus License Agreement”), which provides us with access to Agenus therapeutic candidates and adjuvants for use in our development activities, subject to rights retained by Agenus.
We believe that iNKT cell therapies have the potential to address many of the key limitations of current cell therapy approaches, particularly through the ability to (1) rapidly treat patients real-time after diagnosis, (2) improve response rates and the durability of responses, (3) 5 address more indications and a broader patient population, (4) improve tolerability, (5) be administered without lymphodepletion and (6) scale at a favorable cost profile.
We believe that iNKT cell therapies have the potential to address many of the key limitations of current cell therapy approaches, particularly through the ability to (1) rapidly treat patients real-time after diagnosis, (2) improve response rates and the durability of responses, (3) address more indications and a broader patient population, (4) improve tolerability, (5) be administered without lymphodepletion and (6) scale at a favorable cost profile.
Mechanistically, we have observed that agenT-797: • Homes to tumors; • Activates dendritic cells (signalers that help the immune system recognize tumor cells); • Kills M2 macrophages (immunosuppressive cells that constrain the body’s ability to fight tumors); • Restores tumor killing capacity of exhausted T cells; • Persists beyond our measurement period of 35 days; • Are activated by CD1d, the key ligand for the invariant TCR, and by stress ligands for potent tumor killing; • Can secrete a wide array of inflammatory cytokines to clear infections and tumors; • Recruit and activate NK and T cells to regulate the immune response; and • Dampen inflammatory donor T cell activity to naturally suppress GvHD. iNKT cells use an invariant TCR α-chain and recognize the glycolipid α-GalCer, as well as other exogenous and endogenous glycolipids presented by monomorphic major histocompatibility complex (“MHC”)-I-like CD1d. iNKT cells contribute to natural anti-tumor responses through their IFN- -production and the subsequent activation of DCs, NK cells and cytotoxic T lymphocytes, and their presence within tumors correlates with favorable prognosis in multiple cancers. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress GvHD.
Mechanistically, we have observed that agenT-797: 3 • Homes to tumors; • Activates dendritic cells (signalers that help the immune system recognize tumor cells); • Kills M2 macrophages (immunosuppressive cells that constrain the body’s ability to fight tumors); • Restores tumor killing capacity of exhausted T cells; • Persists beyond our measurement period of 35 days; • Are activated by CD1d, the key ligand for the invariant TCR, and by stress ligands for potent tumor killing; • Can secrete a wide array of inflammatory cytokines to clear infections and tumors; • Recruit and activate NK and T cells to regulate the immune response; and • Dampen inflammatory donor T cell activity to naturally suppress GvHD. iNKT cells use an invariant TCR α-chain and recognize the glycolipid α-GalCer, as well as other exogenous and endogenous glycolipids presented by monomorphic major histocompatibility complex (“MHC”)-I-like CD1d. iNKT cells contribute to natural anti-tumor responses through their IFN- -production and the subsequent activation of DCs, NK cells and cytotoxic T lymphocytes, and their presence within tumors correlates with favorable prognosis in multiple cancers. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress GvHD.
FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters and similar public notice of alleged non-compliance with laws, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, fines, refusals of government contracts, restitution, disgorgement of profits or civil or criminal penalties.
FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters and similar public notice of alleged non-compliance with laws, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, fines, refusals of 9 government contracts, restitution, disgorgement of profits or civil or criminal penalties.
In addition to salaries, these programs include potential annual discretionary bonuses, various stock awards under our equity incentive plans, a 19 401(k) Plan, healthcare and insurance benefits, flexible spending accounts, paid time off, family leave, and flexible work schedules, among others. MiNK Website Our Internet website address is www.minktherapeutics.com.
In addition to salaries, these programs include potential annual discretionary bonuses, various stock awards under our equity incentive plans, a 401(k) Plan, healthcare and insurance benefits, flexible spending accounts, paid time off, family leave, and flexible work schedules, among others. MiNK Website Our Internet website address is www.minktherapeutics.com.
Our near-term plans are to advance the administration of allogeneic iNKT cells in patients undergoing HSCT to enable a successful engraftment and prevention/suppression of acute GvHD. HSCT is a well-established treatment for more than 50,000 adults and children with malignancies, autoimmune conditions and other serious diseases.
Our near-term plans are to advance the administration of allogeneic iNKT cells in patients undergoing HSCT to enable a successful engraftment and prevention/suppression of acute GvHD. HSCT is a well-established treatment for more than 50,000 adults and children with malignancies, autoimmune 6 conditions and other serious diseases.
The invariant TCR can recognize glycolipids presented by CD1d, arming the iNKT cells with the ability to respond to lipid antigenic stimulation within minutes by secreting a wide variety of cytokines. 4 Naturally Suited for Allogeneic Approaches GvHD is an important driver of toxicity with most cell therapy approaches.
The invariant TCR can recognize glycolipids presented by CD1d, arming the iNKT cells with the ability to respond to lipid antigenic stimulation within minutes by secreting a wide variety of cytokines. Naturally Suited for Allogeneic Approaches GvHD is an important driver of toxicity with most cell therapy approaches.
The FDA reviews the application to determine, among other things, whether the proposed product is safe, potent and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
The FDA reviews the application to determine, among other things, whether 13 the proposed product is safe, potent and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.
We are advancing a novel approach through the deployment of iNKT cells, a select subset of T cells with the capabilities to orchestrate both innate and adaptive immunity and the potential to deliver durable memory responses associated with T cell therapies 3 with the cytolytic power of NK cells.
We are advancing a novel approach through the deployment of iNKT cells, a select subset of T cells with the capabilities to orchestrate both innate and adaptive immunity and the potential to deliver durable memory responses associated with T cell therapies with the cytolytic power of NK cells.
When a foreign clinical trial is not conducted under an IND, the sponsor must ensure that the trial complies with certain FDA regulatory requirements in order to use the trial as support for an IND or application for marketing approval in the United States.
When a foreign clinical trial is not conducted under an IND, the sponsor must ensure that the trial complies with certain FDA 11 regulatory requirements in order to use the trial as support for an IND or application for marketing approval in the United States.
Only one patent applicable to an approved product is eligible for the extension, only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended and the application for the extension must be submitted prior to the 18 expiration of the patent in question.
Only one patent applicable to an approved product is eligible for the extension, only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended and the application for the extension must be submitted prior to the expiration of the patent in question.
Higher iNKT cell counts following hematopoietic stem cell transplantation (“HSCT”) for acute leukemia correlates with lower risk for GvHD, and vice versa. Enhanced Tolerability Lymphodepletion is a requirement for most cell therapies and leads to significant side effects.
Higher iNKT cell counts following hematopoietic stem cell transplantation (“HSCT”) for acute leukemia correlates with lower risk for GvHD, and vice versa. 4 Enhanced Tolerability Lymphodepletion is a requirement for most cell therapies and leads to significant side effects.
Failure to comply with the applicable regulatory requirements at any time during the product development 10 process or post-approval may subject an applicant for marketing approval to delays in development or approval, as well as administrative and judicial sanctions.
Failure to comply with the applicable regulatory requirements at any time during the product development process or post-approval may subject an applicant for marketing approval to delays in development or approval, as well as administrative and judicial sanctions.
Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from filing in which to complete its initial review of a standard application and respond to the 14 applicant, and six months for a priority review application.
Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from filing in which to complete its initial review of a standard application and respond to the applicant, and six months for a priority review application.
We believe the expertise of our management team, and the established current Good Manufacturing Processes ("cGMP") manufacturing suite, greatly de-risks the challenges often associated with capital-intensive cell therapy companies. The combined team has a strong track record in discovering and developing immuno-oncology and cell therapies as well as executing on value-accretive business development opportunities.
We believe the expertise of our management team, and the established current Good Manufacturing Processes ("cGMP") site, greatly de-risks the challenges often associated with capital-intensive cell therapy companies. The combined team has a strong track record in discovering and developing immuno-oncology and cell therapies as well as executing on value-accretive business development opportunities.
Our Proprietary Manufacturing Process and Capabilities Our experienced management team and fully operational cGMP manufacturing suite directly address and greatly de-risk the challenges often associated with capital intensive cell therapy companies. We believe this facility pioneered the industrialization and international distribution of autologous cancer vaccines and later the customization of synthetic, off-the-shelf cancer vaccines, immune stimulating adjuvants and antibodies.
Our Proprietary Manufacturing Process and Capabilities Our experienced management team and fully operational cGMP manufacturing suite directly address and greatly de-risk the challenges often associated with capital intensive cell therapy companies. We believe this site pioneered the industrialization and international distribution of autologous cancer vaccines and later the customization of synthetic, off-the-shelf cancer vaccines, immune stimulating adjuvants and antibodies.
These post-approval requirements include, among other things: • record keeping requirements; 16 • reporting of certain adverse experiences with the product and production problems to the FDA; • submission of updated safety and efficacy information to the FDA; • drug sampling and distribution requirements; • notifying FDA and gaining its approval of specified manufacturing and labeling changes; and • compliance with requirements concerning advertising, promotional labeling, industry-sponsored scientific and educational activities and other promotional activities.
These post-approval requirements include, among other things: • record keeping requirements; • reporting of certain adverse experiences with the product and production problems to the FDA; • submission of updated safety and efficacy information to the FDA; 15 • drug sampling and distribution requirements; • notifying FDA and gaining its approval of specified manufacturing and labeling changes; and • compliance with requirements concerning advertising, promotional labeling, industry-sponsored scientific and educational activities and other promotional activities.
Our allogeneic iNKT manufacturing platform allows for cell manufacturing at step function improvement in scale cost, and availability. We are in the process of scaling up our internal manufacturing process to ensure stable, robust and scalable production for advanced clinical trials and commercialization. Our process is designed to scale up > 5,000 doses per batch.
Our allogeneic iNKT manufacturing platform allows for cell manufacturing at step function improvement in scale cost, and availability. We are in the process of scaling up our internal manufacturing process to ensure stable, robust and scalable production for advanced clinical trials and commercialization. Our process is designed to scale up > 5,000 doses per donor.
This efficient isolation and expansion process from healthy donors can generate >5,000 doses per batch. • Access to validated Immuno-oncology therapies : We have access to Agenus’ pipeline of immuno-oncology antibodies, both monospecific and bispecific, and immune stimulating adjuvants for our development activities, which creates the 6 potential for rapid development of combinations and commercial flexibility.
This efficient isolation and expansion process from healthy donors can generate >5,000 doses per donor. • Access to validated Immuno-oncology therapies : We have access to Agenus’ pipeline of immuno-oncology antibodies, both monospecific and bispecific, and immune stimulating adjuvants for our development activities, which creates the potential for rapid development of combinations and commercial flexibility.
The contents of the websites referred to above are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only. 20
The contents of the websites referred to above are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only. 18
We are a clinical stage biopharmaceutical company pioneering a novel platform of living medicines based on a rare and potent class of immune cells called invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (“NK”) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (“GvHD”).
(“we,” “us” and “our”) is a clinical-stage biopharmaceutical company pioneering a novel platform of living medicines based on a rare and potent class of immune cells called invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (“NK”) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (“GvHD”).
Like NK cells, they respond with wide-ranging effector potential, and express a specific invariant TCR that recognizes CD1d, a key monomorphic human leukocyte antigen (“HLA”)-related molecule expressed in a wide range of cancers. iNKT cells have the capacity to mount strong anti-tumor responses both directly and by activating other immune cells, potentiating endogenous NK cells and T cells within the TME.
Like NK cells, they respond with wide-ranging effector potential, and express a specific invariant TCR that recognizes CD1d, a key monomorphic HLA-related molecule expressed in a wide range of cancers. iNKT cells have the capacity to mount strong anti-tumor responses both directly and by activating other immune cells, potentiating endogenous NK cells and T cells within the TME.
These programs are both in preclinical development and IND enabling is underway. In addition, we plan to utilize our bispecific iNKT engagers, TCRs and CAR technologies, as well as our access to a large portfolio of proprietary targets, to further expand our pipeline of novel allogeneic, engineered iNKT cell product candidates.
These programs are both in preclinical development with IND enabling underway for MiNK-215.In addition, we plan to utilize our bispecific iNKT engagers, TCRs and CAR technologies, as well as our access to a large portfolio of proprietary targets, to further expand our pipeline of novel allogeneic, engineered iNKT cell product candidates.
While none of those efforts have focused on changes to the provisions of the Affordable Care Act (ACA) related to the biosimilar regulatory framework, if those efforts continue and if the ACA is repealed, substantially modified or invalidated, it is unclear what, if any, impact such action would have on biosimilar regulation.
While none of those efforts have focused on changes to the provisions of the PPACA related to the biosimilar regulatory framework, if those efforts continue and if the PPACA is repealed, substantially modified or invalidated, it is unclear what, if any, impact such action would have on biosimilar regulation.
This is in line with published data and supports that iNKT cells recognize and actively seek out tumor cells. • Nalm6-CD1d human leukemia xenograft model • 10 million agenT-797 cells injected • Stay in circulation with tumor cells • Home to all tissues with tumor cells • iNKT cells present and active for >21 days • Reduce tumor burden A further active area of our internal research focuses on the combination of iNKT cell therapy and checkpoint inhibitors such as anti-PD-1 and anti-CTLA4 antibodies.
This is in line with published data and supports that iNKT cells recognize and actively seek out tumor cells. • Nalm6-CD1d human leukemia xenograft model • 10 million agenT-797 cells injected • Stay in circulation with tumor cells • Home to all tissues with tumor cells • iNKT cells present and active for >21 days • Reduce tumor burden A further active area of our internal research focuses on the combination of iNKT cell therapy and checkpoint inhibitors such as anti-PD-1 and anti-CTLA4 antibodies. 7 Our internal preclinical research indicates expanded anti-tumor activity of iNKT cells when used in combination with immuno-oncology antibodies, including anti-PD-1 and anti-CTLA-4 antibodies.
Other key competitors in the  T cell therapy space include, but are not limited to, Adicet Bio, Inc., GammaDelta Therapeutics Limited, In8bio, Inc. and TC BioPharm Limited. Many of our competitors have initiated clinical trials for GvHD, solid tumors and multiple myeloma, settings in which our iNKT cell therapy platform is currently being investigated.
Other key competitors in the gd T cell therapy space include, but are not limited to, Adicet Bio, Inc., GammaDelta Therapeutics Limited, In8bio, Inc. and TC BioPharm Limited. Many of our competitors have initiated clinical trials for solid tumors, hematological malignancies and autoimmune indications, settings in which our iNKT cell therapy platform is currently being investigated.
These cells have the unique ability to bridge the innate and adaptive immune system, with the killing power of NK cells and memory of T cells, as well as the ability to recruit host immunity and reshape the TME. • Broad therapeutic capability: Our pipeline of native and engineered iNKT cell candidates has opportunity across a range of disease settings, including in oncology and immune-mediated diseases. • Clinical proof of concept: Our three phase 1 clinical trials have demonstrated the tolerability and immune-modulating activity of allogeneic iNKT cells in multiple cancers and ARDS.
These cells have the unique ability to bridge the innate and adaptive immune system, with the killing power of NK cells and memory of T cells, as well as the ability to recruit host immunity and reshape the TME. • Broad therapeutic capability: Our pipeline of native and engineered iNKT cell candidates has opportunity across a range of disease settings, including in oncology and immune-mediated diseases. 5 • Clinical proof of concept: Our Phase 1 clinical trials have demonstrated the tolerability and immune-modulating activity of allogeneic iNKT cells in multiple cancer types and ARDS . • Proprietary cell engineering : Our engineering platforms enable the discovery of CARs, TCRs, and bispecific engagers.
The most common life-threatening complication, which occurs in approximately 50% of HSCTs, is graft failure and GvHD driven by immunocompetent T cells in the graft recognizing host tissues. Current pre-conditioning therapies such as cytotoxic chemotherapies produce inferior responses in patients over 65 years old.
The most common life-threatening complication, which occurs in approximately 50% of HSCTs, is graft failure and GvHD driven by immunocompetent T cells in the graft recognizing host tissues. Current pre-conditioning therapies such as cytotoxic chemotherapies produce inferior responses in patients over 65 years old. Furthermore, failure to engraft and downstream GvHD are associated with cancer recurrence or death.
Human Capital Resources and Employees As of March 1, 2023, we had 37 full-time employees, 59% of whom have M.D. or Ph.D. degrees. Our ability to manage growth effectively will require us to continue to implement and improve our management systems, recruit and train new employees and select qualified independent contractors.
Human Capital Resources and Employees As of March 15, 2024, we had 31 full-time employees, 52% of whom have Ph.D. degrees. Our ability to manage growth effectively will require us to continue to implement and improve our management systems, recruit and train new employees and select qualified independent contractors.
We believe this will enable us to further increase reproducibility, minimize run failures and greatly increase scalability. 9 Immuno-Oncology Combination Therapy Collaboration with Agenus While we have retained the rights to develop our wholly owned or exclusively licensed pipeline independent of Agenus, we have entered into Agenus Agreement which provides us with access to immuno-oncology antibodies, adjuvants and other potential synergistic combinations, and intend to pursue the development of combination products between our allogeneic iNKT cell product candidates and products in Agenus’ immuno-oncology portfolio.
Immuno-Oncology Combination Therapy Collaboration with Agenus While we have retained the rights to develop our wholly owned or exclusively licensed pipeline independent of Agenus, we have entered into Agenus Agreement which provides us with access to immuno-oncology antibodies, adjuvants and other potential synergistic combinations, and intend to pursue the development of combination products between our allogeneic iNKT cell product 8 candidates and products in Agenus’ immuno-oncology portfolio.
This closed-system process reduces hands-on time and optimizes personnel usage and facility qualification and validation processes. Our proprietary reagents and process generate a product that is over 99% pure iNKT cells that can be stably cryopreserved with full retention of functional properties.
This closed-system process reduces hands-on time and optimizes personnel usage and facility qualification and validation processes. Our proprietary reagents and process generate a product that is over 99% pure iNKT cells that can be stably cryopreserved with full retention of functional properties. We believe this will enable us to further increase reproducibility, minimize run failures and greatly increase scalability.
Absent a showing of clinical superiority, the FDA cannot approve the same product made by another manufacturer for the 17 same indication during the market exclusivity period unless it has the consent of the sponsor or the sponsor is unable to provide sufficient quantities.
Absent a showing of clinical superiority, the FDA cannot approve the same product made by another manufacturer for the same indication during the market exclusivity period unless it has the consent of the sponsor or the sponsor is unable to provide sufficient quantities. 16 A sponsor may request orphan drug designation of a previously unapproved product or new orphan indication for an already marketed product.
An IND must contain the results of the preclinical tests, manufacturing information, analytical data, any available clinical data or literature, a proposed clinical 11 protocol, an investigator’s brochure, a sample informed consent form, and other materials. Some preclinical testing, such as toxicity studies, may continue even after the IND is submitted.
An IND must contain the results of the preclinical tests, manufacturing information, analytical data, any available clinical data or literature, a proposed clinical protocol, an investigator’s brochure, a sample informed consent form, and other materials.
As of December 31, 2022, we own one issued U.S. patent and 28 pending U.S. and foreign patent applications. The issued patent is directed to a process for the discovery of TCRs and the term of the patent will expire in 2029.
As of December 31, 2023, we own three issued U.S. patents and 25 pending patent applications in the U.S. and other major jurisdictions worldwide. One of the issued U.S. patents is directed to a process for the discovery of TCRs and the term of the patent will expire in 2041.
It is a hybrid of phage and mammalian display technologies, enabling direct functional selection from cellular immune libraries. This yields a higher frequency of candidate hits with improved pharmaceutical quality and eliminates tonic signaling at an early stage.
This includes CARDIS, our novel CAR discovery and engineering platform developed fully in house over the last five years. It is a hybrid of phage and mammalian display technologies, enabling direct functional selection from cellular immune libraries. This yields a higher frequency of candidate hits with improved pharmaceutical quality and eliminates tonic signaling at an early stage.
Clinical trials are conducted under study protocols detailing, among other things, the objectives of the study, inclusion and exclusion criteria, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated.
Clinical trials are conducted under study protocols detailing, among other things, the objectives of the study, inclusion and exclusion criteria, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.
An IND is an exemption from the FDCA that allows an unapproved drug or biological product to be shipped in interstate commerce for use in an investigational clinical trial.
Some preclinical testing, such as toxicity studies, may continue even after the IND is submitted. 10 An IND is an exemption from the FDCA that allows an unapproved drug or biological product to be shipped in interstate commerce for use in an investigational clinical trial.
Because this is a relatively new and expanding area of novel therapeutic interventions, there can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy products, or that the data generated in these trials will be acceptable to the FDA to support marketing approval.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients. 12 Because this is a relatively new and expanding area of novel therapeutic interventions, there can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy products, or that the data generated in these trials will be acceptable to the FDA to support marketing approval.
A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews and approves the application for any patent term extension or restoration in consultation with the FDA.
A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals.
We are also aware of competitors advancing glycolipid formulations designed to activate endogenous iNKT cells, including Portage Biotech LLC and Abivax SA. Key competitors developing allogeneic T cell therapies include, but are not limited to, Allogene Therapeutics, Inc., Atara Biotherapeutics, Inc., Cellectis S.A., Celyad Oncology SA, CRISPR Therapeutics AG, Poseida Therapeutics, Inc. and Precision BioSciences, Inc.
Key competitors developing allogeneic T cell therapies include, but are not limited to, Allogene Therapeutics, Inc., Atara Biotherapeutics, Inc., Cellectis S.A., Celyad Oncology SA, CRISPR Therapeutics AG, Poseida Therapeutics, Inc. and Precision BioSciences, Inc.
We are also developing two preclinical CAR-iNKT programs targeting BCMA, MiNK-413, and a tumor stromal FAP targeting, MiNK-215. agenT-797 – Oncology In preclinical studies we have observed that agenT-797 cells have the potential to reduce or eliminate hematologic and solid tumor cancers as a monotherapy and in combination with checkpoint modulating antibodies, as they (1) home to sites of disease via CD1d and NK related ligands; (2) attack suppressive myeloid cells in the TME to eliminate tumor escape mechanisms; (3) recruit and activate NK cells and T cells for enhanced tumor killing (a distinguishing feature not shared by other innate lymphocytes such as NK and gamma delta T cells); and (4) promote tumor killing without lymphodepletion.
Our Product Candidate agenT-797 agenT-797, our allogeneic, native iNKT cell therapy, is our most advanced product candidate and is currently in clinical development across multiple different trials and indications, constituting a pipeline within a single product. agenT-797 – Oncology In preclinical studies, we have observed that agenT-797 cells have the potential to reduce or eliminate hematologic and solid tumor cancers as a monotherapy and in combination with checkpoint modulating antibodies, as they (1) home to sites of disease via CD1d and NK related ligands; (2) attack suppressive myeloid cells in the TME to eliminate tumor escape mechanisms; (3) recruit and activate NK cells and T cells for enhanced tumor killing (a distinguishing feature not shared by other innate lymphocytes such as NK and gamma delta T cells); and (4) promote tumor killing without lymphodepletion. 34 solid tumor patients have been enrolled in our Phase 1 clinical trial.
Other modalities such as bispecific antibodies, antibody drug conjugates, as well as novel immuno-oncology antibodies, are also capable of enabling infiltration of immune cells to the site of the tumor.
Several companies are also using induced pluripotent stem cells as an allogeneic cell source, which could theoretically have enhanced scalability. Other modalities such as bispecific antibodies, antibody drug conjugates, as well as novel immuno-oncology antibodies, are also capable of enabling infiltration of immune cells to the site of the tumor.
Our bispecific iNKT cell engagers are designed to expand tumor targeting in tumors that are difficult to treat due to immunologic or biologic factors, which may include low CD1d expression. Our engagers bind to the invariant TCR with one arm, and to tumor targets with the other arm.
In addition to genetically engineered CAR-expressing iNKT products, we are developing bispecific iNKT cell engagers. Our bispecific iNKT cell engagers are designed to expand tumor targeting in tumors that are difficult to treat due to immunologic or biologic factors, which may include low CD1d expression.
We are employing iNKT cells in their native form in diseases where iNKT cells have demonstrated activity and accelerated approval pathways exist. These indications include, but are not limited to oncology, and acute respiratory distress (“ARDS”) secondary to life-threatening infectious diseases.
We are employing iNKT cells in their native form, through our lead program agenT-797, in diseases where iNKT cells have demonstrated activity and accelerated approval pathways exist. These indications include but are not limited to solid tumor cancers, acute respiratory distress (“ARDS”) and other severe immune-related diseases, such as GvHD.
Competition The biopharmaceutical industry, and particularly the immuno-oncology field, is characterized by rapidly advancing and changing technologies with intense competition. Cell therapy is one of the most active areas for the discovery and clinical development of new anti-cancer therapies. It involves the delivery of immune cells to the site of the tumor to mediate killing.
The USPTO reviews and approves the application for any patent term extension or restoration in consultation with the FDA. 17 Competition The biopharmaceutical industry, and particularly the immuno-oncology field, is characterized by rapidly advancing and changing technologies with intense competition. Cell therapy is one of the most active areas for the discovery and clinical development of new anti-cancer therapies.
However, the FDA’s time period goal for reviewing a Fast Track application does not begin until the last section of the application is submitted. In addition, the Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
In addition, the Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
For Fast Track products, sponsors may have more frequent interactions with the FDA 15 and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete.
For Fast Track products, sponsors may have more frequent interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective.
In addition to survival benefit, we demonstrated that that we can dose the cells to 1x109 cells/dose with no related cytokine release syndrome or neurotoxicity and importantly, observed signals that the cells may prevent secondary infections.
In addition to survival benefit, we demonstrated that we can dose the cells to 1x109 cells/dose with no related cytokine release syndrome or neurotoxicity and importantly, observed signals that the cells may prevent secondary infections. agenT-797 – GvHD iNKT cells have the potential to provide the following benefits in relation to GvHD: (1) promoting engraftment success; (2) mitigating or suppressing GvHD; and (3) promoting durable responses in patients with cancer.
In a highly checkpoint inhibitor-resistant metastatic murine tumor model we have observed nearly complete tumor clearance when the mice are treated with a combination of anti-PD-1 and Fc-enhanced CTLA4 antibodies, and endogenously expanded and activated murine iNKT cells. 8 We intend to capitalize on our internal research findings and actively pursue preclinical and clinical development of iNKT cells in combination with immuno-oncology antibodies for treatment of solid tumors.
These increase the ability of iNKT cells to control tumors by further increasing immune cell infiltration and reducing metastases. In a highly checkpoint inhibitor-resistant metastatic murine tumor model we have observed nearly complete tumor clearance when the mice are treated with a combination of anti-PD-1 and Fc-enhanced CTLA4 antibodies, and endogenously expanded and activated murine iNKT cells.
Our two most advanced engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen (“BCMA), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies.
In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen (“BCMA), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program.
We appreciate that there may be significant potential over time to enhance the efficacy and addressable population of our products through combination of our iNKT cells with other classes of therapeutics.
We appreciate that there may be significant potential over time to enhance the efficacy and addressable population of our products through combination of our iNKT cells with other classes of therapeutics. In December 2023, we entered into a collaboration agreement with Immunoscape to discover and develop next-generation T-cell receptor ("TCR") therapies against novel targets in solid tumors.
When a foreign clinical trial is conducted under an IND, all FDA IND requirements must be met unless waived.
A sponsor who wishes to conduct a clinical trial outside the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. When a foreign clinical trial is conducted under an IND, all FDA IND requirements must be met unless waived.
The resulting CAR-iNKT cells exhibit an augmented and finely integrated response to the 7 tumor through a combination of CAR target recognition, TCR activation and innate receptor activation by CD1d or stress ligands in the TME. In addition to genetically engineered CAR-expressing iNKT products, we are developing bispecific iNKT cell engagers.
They increase the range of tumor targets that can be addressed by iNKT cells and carry optimized intracellular domains that augment and expand native signaling. The resulting CAR-iNKT cells exhibit an augmented and finely integrated response to the tumor through a combination of CAR target recognition, TCR activation and innate receptor activation by CD1d or stress ligands in the TME.
We commenced a Phase 1 clinical trial of agenT-797 for the treatment of ARDS secondary to COVID-19 during the height of the COVID-19 pandemic and expanded the trial into viral ARDS secondary to other life-threatening infectious diseases, such as influenza.
We completed a Phase 1 clinical trial of agenT-797 for the treatment of ARDS secondary to COVID-19, which was initiated during the height of the COVID-19 pandemic, and we subsequently expanded the trial to investigate viral ARDS secondary to other life-threatening infectious diseases, such as influenza In a cohort of 21 patients with mechanical ventilation, the survival rates from this study exceeded 70%, with a 80% survival rate among those patients (5) on VV ECMO.
Our Phase 1 clinical trial studying agenT-797 in solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab, is currently advancing as a priority program.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. Our Phase 1 clinical trial has enrolled 34 patients and is evaluating agenT-797 in refractory solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab.
We face substantial competition from many different entities, including large pharmaceutical companies, small and midsize biotechnology companies, and academic research institutions. These competitors are focused on engineering multiple immune cell types including NK cells, α T cells and  T cells, in addition to iNKT cells.
It involves the delivery of immune cells to the site of the tumor to mediate killing. We face substantial competition from many different entities, including large pharmaceutical companies, small and midsize biotechnology companies, and academic research institutions.
More specifically, these patent applications are intended to protect intellectual property relating to a TCR for cell therapy targeting NY-ESO-1 and a TCR for cell therapy targeting a PTT.
The other two issued U.S. patents are intended to protect intellectual property relating to a TCR for cell therapy targeting NY-ESO-1 and a TCR for cell therapy targeting Phosphopeptides. The term of these two patents will expire in 2039.
These products are both autologous and allogeneic (i.e., derived from a healthy donor) in nature and are unmodified or genetically engineered to target ligands with CARs or TCRs. Several companies are also using induced pluripotent stem cells as an allogeneic cell source, which could theoretically have enhanced scalability.
These competitors are focused on engineering multiple immune cell types including NK cells, α b T cells and gd T cells, in addition to iNKT cells. These products are both autologous and allogeneic (i.e., derived from a healthy donor) in nature and are unmodified or genetically engineered to target ligands with CARs or TCRs.
Our discovery efforts are focused applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, starting with MiNK-413, BCMA-CAR-iNKT, and MiNK-215, FAP-CAR-iNKT. 1 The following table summarizes our current product development pipeline: * Autologous T cell program IND-Ready; allogeneic iNKT program in development. Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy.
Our discovery efforts are focused applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including TCRs, CAR-INKTS (such as, MiNK-215, FAP-CAR-iNKT and MiNK-413. BCMA-CAR-iNKT), and engager technology. 1 The following table summarizes our current product development pipeline: 1 Agenus Inc, therapeutic candidates botensilimab (BOT, Fc-enhanced anti-CTLA-4) and balstilimab (BAL, anti-PD-1).
Our CARs are designed to work in conjunction with the invariant TCR and the array of innate receptors expressed natively by iNKT cells. They increase the range of tumor targets that can be addressed by iNKT cells and carry optimized intracellular domains that augment and expand native signaling.
We entered into a collaboration agreement with Immunoscape to discover and develop next-generation TCR therapies against novel targets in solid tumors. Our CARs are designed to work in conjunction with the invariant TCR and the array of innate receptors expressed natively by iNKT cells.
(Kite Pharma), Adaptimmune LLC, Janssen Pharmaceutica N.V., and Novartis AG. Key competitors developing iNKT cell therapies include Athenex, Inc., Arovella Therapeutics (previously known as Suda Pharmaceuticals), Appia Bio, Inc., Brightpath Biotherapeutics and Ambicion Co.. While one of Athenex’s programs is autologous in nature, other iNKT competitor programs are allogeneic in format.
(Kite Pharma), Johnson & Johnson, Novartis AG, AstraZeneca and BioNTech. Key competitors developing iNKT cell therapies include Arovella Therapeutics (previously known as Suda Pharmaceuticals), Appia Bio, Inc., Brightpath Biotherapeutics and Ambicion Co. We are also aware of competitors advancing glycolipid formulations or small molecules designed to activate endogenous iNKT cells, including Portage Biotech LLC, Abivax SA and Gri Bio.
This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective. The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees.
The sponsor must also provide, and the FDA must approve, a schedule for the submission of the 14 remaining information and the sponsor must pay applicable user fees. However, the FDA’s time period goal for reviewing a Fast Track application does not begin until the last section of the application is submitted.
Encouraging early activity was seen with agenT-797 monotherapy and combination, with reductions in target and non-target lesions or disease stabilization in patients, which was presented at Society of Immunotherapy for Cancer (“SITC”) in 2022. We currently expect to have updated readouts from this clinical trial in 2023.
Encouraging early activity was seen with agenT-797 monotherapy and combination, with reductions in target and non-target lesions and disease stabilization, which included a durable partial response in a PD-1 refractory gastric cancer patient.
Agenus will not be obligated to provide us access to their biological material in certain limited circumstances. Our Product Candidate agenT-797 AgenT-797, our allogeneic, native iNKT cell therapy, is our most advanced product candidate and is currently in clinical development across multiple different trials and indications, constituting a pipeline within a single product.
Agenus will not be obligated to provide us access to their biological material in certain limited circumstances.
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We commenced a Phase 1 clinical trial of agenT-797 for the treatment of multiple myeloma, and reported that agenT-797 was tolerable to 1x109 cells/dose and suppressed biomarkers associated with disease progression at SITC in 2022.
Added
AgenT-797 also showed long-term persistence (detected in the periphery for up to 6 months), which was independent of human leukocyte antigen ("HLA") matching and in absence of lymphodepletion. These data were presented at Society of Immunotherapy for Cancer (“SITC”) in 2023. In addition, a case study on the gastric cancer response was published in Oncogene in January 2024.
Removed
This POC phase 1 underscores the potential application of INKTs in multiple myeloma and establishes important novel data to support the advancement of our armored BCMA-CAR-INKT program as a potential best in class next generation allogeneic BCMA cell therapy for these patients. Strategic discussions to advance this program are underway.
Added
Most recently, a Phase 2 investigator sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center was launched.
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With the unique circumstances of the COVID-19 pandemic, we commenced a Phase 1 clinical trial of agenT-797 in viral ARDS and reported an encouraging survival benefit of 70%, compared to ~10-22% in an in-hospital control and time-matched data from the CDC.
Added
This study will evaluate the clinical safety and efficacy of the combination of agenT-797, Agenus Inc.'s ("Agenus") botensilimab (a novel fc-enhanced CTLA-4 inhibitor (plus balstilimab (anti-PD-1) with ramucirumab and paclitaxel for patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction ("GEJ") adenocarcinoma.
Removed
These data were presented at SITC 2022 and we have planned an update from the trial in the first half of 2023 and a formal scientific publication is currently in review.
Added
The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of these cancers who have experienced disease progression after initial treatment. With the unique circumstances of the COVID-19 pandemic, we commenced a Phase 1 clinical trial to investigate agenT-797 in moderate to severe viral ARDS, a setting where there are currently no approved therapies.
Removed
There are currently no approved therapies for ARDS; our data contribute favorably as a potential therapeutic and we plan to externally finance the advancement of agenT-797 in viral ARDS through strategic collaborations. Discussions are underway. In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs.
Added
In a cohort of 21 patients with mechanical ventilation, survival rates exceeded 70%, with an 80% survival rate among those patients (5) on veno-venous extracorreal membrane oxygenation (“VV ECMO"). These data compared favorably to the 10% survival rate in the in-hospital control group at the same time.
Removed
MiNK-215 has demonstrated robust efficacy in NSCLC and melanoma preclinical models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration through tumor stroma. These data and programs were presented at SITC in 2022. These programs are both in preclinical development with investigational new drug application (“IND”) enabling activities underway in 2023.
Added
The full results from this study were published in Nature Communications in February 2024 and data from the subset of patients on VV ECMO were presented at the American Thoracic Society Annual Meeting in 2023. We plan to further advance agenT-797 in viral ARDS through an externally funded, large platform trial.
Removed
MiNK was born out of the veteran immuno-oncology company, Agenus Inc. ("Agenus"). The foundational leadership team is comprised of individuals who were critical to the delivery of the numerous scientific and clinical milestones at Agenus since 2015.
Added
MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. These data were presented at SITC in 2022. MiNK-215 reported therapeutic activity in non-small cell lung cancer models, which resulted in substantial tumor elimination and improved survival compared to T cells alone.
Removed
In addition to building Agenus from 50 to approximately 450 employees, this team has advanced 17 discoveries to the clinic and secured approximately $800 million in upfront and milestone payments and equity investments through partnering transactions, with the most recent achievement being a significant collaboration with Bristol-Myers Squibb Company on a preclinical antibody targeting TIGIT, which included a $200 million upfront payment and up to $1.36 billion in milestone payments in addition to royalties on net product sales. 2 This foundational leadership team has recruited and assembled a management team who bring extensive industry expertise to our company, including decades of experience in manufacturing autologous and off-the-shelf products.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Related to Regulatory Review and Other Legal Compliance Matters • If our clinical trials fail to demonstrate safety and efficacy, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of product candidates. • We may experience delays or difficulties in the enrollment of patients in our clinical trials. • The regulatory landscape that will govern any product candidates we may develop is uncertain and may change. • Any failure to comply with laws and regulations could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. • Healthcare and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize any product candidates.
Biggest changeRisks Related to Regulatory Review and Other Legal Compliance Matters • If our clinical trials fail to demonstrate safety and efficacy, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of product candidates. • We may experience delays or difficulties in the enrollment of patients in our clinical trials. • The regulatory landscape that will govern any product candidates we may develop is uncertain and may change. • Any failure to comply with laws and regulations could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. • Healthcare and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize any product candidates. • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, or we may fail to satisfy certain arrangements with governmental authorities. • Laws and regulations governing our international operations may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us implement costly compliance programs. • We are subject to stringent privacy and information security laws, regulations, policies and contractual obligations and changes in such laws, regulations, policies and contractual obligations could adversely affect our business. 19 Risks Related to Our Relationship with Agenus • We may experience difficulty in separating our resources from Agenus. • Agenus owns a majority of our common stock and will be able to exert control over specific matters subject to stockholder approval. • Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Agenus.
For example: • any product candidates we may develop will eventually become commercially available in generic or biosimilar product forms; • others may be able to make adoptive cell therapy products that are similar to any product candidates we may develop or utilize similar cell-based immunotherapies but that are not covered by the claims of the patents that we license or may own in the future; • we, or our license partners or current or future collaborators, might not have been the first to make the inventions covered by issued patents or pending patent applications that we license or own, currently or in the future; • we, or our license partners or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions; • we, or our license partners or current or future collaborators, may fail to meet our obligations to the U.S. government regarding any patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights; 56 • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; • it is possible that our pending or potential future owned or licensed patent applications or those that we may own in the future will not lead to issued patents; • it is possible that there are prior public disclosures that could invalidate our patent, or parts of our patent; • it is possible that there are unpublished applications or patent applications maintained in secrecy that may later be issued with claims covering our product candidates or therapies similar to ours; • it is possible that our current and future patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable; • issued patents that we hold rights to may be held invalid, unenforceable or narrowed in scope, including as a result of legal challenges by our competitors; • the claims of our patent or patent applications, if and when issued, may not cover our product candidates; • the laws of foreign countries may not protect our proprietary rights or the proprietary rights of license partners or current or future collaborators to the same extent as the laws of the United States; • the inventors of our current and future patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to us or uncooperative as to the patents or patent applications on which they are named as inventors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we have engaged in scientific collaborations in the past and will continue to do so in the future and our collaborators may develop adjacent or competing products that are outside the scope of our patents; • we may not develop additional proprietary technologies that are patentable; • any product candidates we develop may be covered by third parties’ patents or other exclusive rights; • the patents of others may harm our business; or • we may choose not to file a patent application in order to maintain certain subject matter as trade secrets or know-how, and a third party may subsequently develop and file a patent application disclosing the same subject matter.
For example: • any product candidates we may develop will eventually become commercially available in generic or biosimilar product forms; • others may be able to make adoptive cell therapy products that are similar to any product candidates we may develop or utilize similar cell-based immunotherapies but that are not covered by the claims of the patents that we license or may own in the future; • we, or our license partners or current or future collaborators, might not have been the first to make the inventions covered by issued patents or pending patent applications that we license or own, currently or in the future; • we, or our license partners or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions; • we, or our license partners or current or future collaborators, may fail to meet our obligations to the U.S. government regarding any patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; • it is possible that our pending or potential future owned or licensed patent applications or those that we may own in the future will not lead to issued patents; • it is possible that there are prior public disclosures that could invalidate our patent, or parts of our patent; • it is possible that there are unpublished applications or patent applications maintained in secrecy that may later be issued with claims covering our product candidates or therapies similar to ours; • it is possible that our current and future patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable; • issued patents that we hold rights to may be held invalid, unenforceable or narrowed in scope, including as a result of legal challenges by our competitors; • the claims of our patent or patent applications, if and when issued, may not cover our product candidates; • the laws of foreign countries may not protect our proprietary rights or the proprietary rights of license partners or current or future collaborators to the same extent as the laws of the United States; • the inventors of our current and future patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to us or uncooperative as to the patents or patent applications on which they are named as inventors; • our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we have engaged in scientific collaborations in the past and will continue to do so in the future and our collaborators may develop adjacent or competing products that are outside the scope of our patents; • we may not develop additional proprietary technologies that are patentable; • any product candidates we develop may be covered by third parties’ patents or other exclusive rights; • the patents of others may harm our business; or • we may choose not to file a patent application in order to maintain certain subject matter as trade secrets or know-how, and a third party may subsequently develop and file a patent application disclosing the same subject matter.
The success of product candidates we may identify and develop will depend on many factors, including the following: • sufficiency of our financial and other resources to complete the necessary preclinical studies, IND-enabling studies and clinical trials; • successful enrollment in, and completion of, clinical trials; • receipt of marketing approvals from applicable regulatory authorities; • establishment of arrangements with third-party manufacturers for clinical supply and commercial manufacturing and, where applicable, commercial manufacturing capabilities; 26 • successful development of our internal manufacturing processes and transfer to larger-scale facilities operated by either a contract manufacturing organization (“CMO”) or by us; • obtaining and maintaining patent, trade secret and other intellectual property protection and non-patent exclusivity for our medicines; • launching commercial sales of the medicines, if and when approved, whether alone or in collaboration with others; • acceptance of the products, if and when approved, by patients, the medical community and third-party payors; • effectively competing with other therapies and treatment options; • a continued acceptable safety profile of the medicines following approval; • enforcing and defending intellectual property and proprietary rights and claims; and • supplying the products at a price that is acceptable to the pricing or reimbursement authorities in different countries.
The success of product candidates we may identify and develop will depend on many factors, including the following: • sufficiency of our financial and other resources to complete the necessary preclinical studies, IND-enabling studies and clinical trials; • successful enrollment in, and completion of, clinical trials; • receipt of marketing approvals from applicable regulatory authorities; • establishment of arrangements with third-party manufacturers for clinical supply and commercial manufacturing and, where applicable, commercial manufacturing capabilities; • successful development of our internal manufacturing processes and transfer to larger-scale facilities operated by either a contract manufacturing organization (“CMO”) or by us; • obtaining and maintaining patent, trade secret and other intellectual property protection and non-patent exclusivity for our medicines; • launching commercial sales of the medicines, if and when approved, whether alone or in collaboration with others; • acceptance of the products, if and when approved, by patients, the medical community and third-party payors; • effectively competing with other therapies and treatment options; • a continued acceptable safety profile of the medicines following approval; • enforcing and defending intellectual property and proprietary rights and claims; and • supplying the products at a price that is acceptable to the pricing or reimbursement authorities in different countries.
If our operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the 39 curtailment or restructuring of our operations, any of which could adversely affect our business, financial condition, results of operations and prospects.
If our operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which could adversely affect our business, financial condition, results of operations and prospects.
Third parties may assert that we are employing their proprietary technology without authorization and may file patent infringement lawsuits against us, and if we are found to infringe such third-party patents, we may be required to pay damages, cease commercialization of the infringing technology or obtain a license from such third parties, which may not be available on commercially reasonable terms or at all.
Third parties may assert that we are employing their proprietary technology without authorization and may file patent infringement lawsuits against us, and if we are found to infringe such third-party patents, we may be 52 required to pay damages, cease commercialization of the infringing technology or obtain a license from such third parties, which may not be available on commercially reasonable terms or at all.
Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the United States could revoke approval of the combination therapy used with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies.
Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the United States could revoke approval of the combination therapy used with our 23 product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies.
Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for any product candidates we develop and for our cell-based immunotherapies, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and therapies similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our cell-based immunotherapies may be adversely affected.
Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for any product candidates we develop and for our cell-based immunotherapies, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and therapies similar or identical to ours, and our 46 ability to successfully commercialize any product candidates we may develop, and our cell-based immunotherapies may be adversely affected.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects. Intellectual property rights do not necessarily address all potential threats.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects. 56 Intellectual property rights do not necessarily address all potential threats.
Securities litigation could result in substantial costs and divert management’s attention and resources from our business. We do not expect to pay any dividends for the foreseeable future. Investors may never obtain a return on their investment. You should not rely on an investment in our common stock to provide dividend income.
Securities litigation could result in substantial costs and divert management’s attention and resources from our business. 62 We do not expect to pay any dividends for the foreseeable future. Investors may never obtain a return on their investment. You should not rely on an investment in our common stock to provide dividend income.
While we continue to outsource our finance and accounting personnel, we have begun recruiting additional finance and accounting personnel with certain skill sets that we need as a public company. 62 Implementing any appropriate changes to our internal controls may distract our officers and employees, entail substantial costs to modify our existing processes and take significant time to complete.
While we continue to outsource our finance and accounting personnel, we have begun recruiting additional finance and accounting personnel with certain skill sets that we need as a public company. Implementing any appropriate changes to our internal controls may distract our officers and employees, entail substantial costs to modify our existing processes and take significant time to complete.
A fast track, breakthrough or RMAT designation does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe. In addition, the FDA may withdraw fast track, breakthrough or RMAT designation if it believes that the designation is no longer supported by data from our clinical development program.
A fast track, breakthrough or RMAT designation does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe. In addition, the FDA may withdraw fast track, breakthrough 38 or RMAT designation if it believes that the designation is no longer supported by data from our clinical development program.
In addition, even after an orphan drug is 41 approved, the FDA can subsequently approve the same product candidate for the same condition if the FDA concludes that the later product candidate is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care compared with the product that has orphan exclusivity.
In addition, even after an orphan drug is approved, the FDA can subsequently approve the same product candidate for the same condition if the FDA concludes that the later product candidate is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care compared with the product that has orphan exclusivity.
The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring 40 the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
Net prices for medicines may be reduced by mandatory discounts or rebates required to be provided to government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of medicines from countries where they may be sold at lower prices than in the United States.
Net prices for medicines may be reduced by mandatory discounts or rebates required to be provided to government 29 healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of medicines from countries where they may be sold at lower prices than in the United States.
Patient enrollment is also affected by other factors, including: • severity of the disease under investigation; • size of the patient population and process for identifying patients; • design of the trial protocol; • availability and efficacy of approved medications for the disease under investigation; • ability to obtain and maintain patient informed consent; • risk that enrolled patients will drop out before completion of the trial; • eligibility and exclusion criteria for the trial in question; • perceived risks and benefits of the product candidate under trial; • perceived risks and benefits of adoptive cell therapy as a therapeutic approach; • efforts to facilitate timely enrollment in clinical trials; • patient referral practices of physicians; 35 • ability to monitor patients adequately during and after treatment; and • proximity and availability of clinical trial sites for prospective patients, especially for those conditions which have small patient pools.
Patient enrollment is also affected by other factors, including: • severity of the disease under investigation; • size of the patient population and process for identifying patients; • design of the trial protocol; • availability and efficacy of approved medications for the disease under investigation; • ability to obtain and maintain patient informed consent; • risk that enrolled patients will drop out before completion of the trial; • eligibility and exclusion criteria for the trial in question; • perceived risks and benefits of the product candidate under trial; • perceived risks and benefits of adoptive cell therapy as a therapeutic approach; 33 • efforts to facilitate timely enrollment in clinical trials; • patient referral practices of physicians; • ability to monitor patients adequately during and after treatment; and • proximity and availability of clinical trial sites for prospective patients, especially for those conditions which have small patient pools.
As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our future in-licensed patents and patent applications may in the future be co-owned by our licensors with third parties.
As a result, our intellectual 47 property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our future in-licensed patents and patent applications may in the future be co-owned by our licensors with third parties.
In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales 39 commission, customer incentive programs and other business arrangements.
In addition, later discovery of previously unknown problems with our medicines, manufacturers, or manufacturing processes, or failure to comply with regulatory requirements, may yield various negative consequences, including: • restrictions on such medicines, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a medicine; • restrictions on the distribution or use of a medicine; • requirements to conduct post-marketing clinical trials; • receipt of warning or untitled letters; • withdrawal of the medicines from the market; • refusal to approve pending applications or supplements to approved applications that we submit; • recall of medicines; • fines, restitution or disgorgement of profits or revenue; • restrictions on future procurements with governmental authorities; 38 • suspension or withdrawal of marketing approvals; • suspension of any ongoing clinical trials; • refusal to permit the import or export of our medicines; • product seizure; and • injunctions or the imposition of civil or criminal penalties.
In addition, later discovery of previously unknown problems with our medicines, manufacturers, or manufacturing processes, or failure to comply with regulatory requirements, may yield various negative consequences, including: • restrictions on such medicines, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a medicine; • restrictions on the distribution or use of a medicine; • requirements to conduct post-marketing clinical trials; • receipt of warning or untitled letters; • withdrawal of the medicines from the market; • refusal to approve pending applications or supplements to approved applications that we submit; • recall of medicines; • fines, restitution or disgorgement of profits or revenue; • restrictions on future procurements with governmental authorities; • suspension or withdrawal of marketing approvals; • suspension of any ongoing clinical trials; • refusal to permit the import or export of our medicines; 36 • product seizure; and • injunctions or the imposition of civil or criminal penalties.
We cannot provide any assurance that additional data will be provided frequently or that data updates will be available at any particular time. Furthermore, while patients with who have been treated with our product candidates may have a positive response, there can be no assurance that their progress or recovery will be sustained.
We cannot provide any assurance that additional data will be provided frequently or that data updates will be available at any particular time. Furthermore, while patients with who have 26 been treated with our product candidates may have a positive response, there can be no assurance that their progress or recovery will be sustained.
If we are found to infringe a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such patents are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing and 52 marketing any product candidates we may develop and our technology.
If we are found to infringe a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such patents are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing any product candidates we may develop and our technology.
The anti-bribery provisions of the FCPA are enforced primarily by the Department of Justice. The Securities and Exchange Commission (the “SEC”) is involved with enforcement of the books and records provisions of the FCPA. 58 Similarly, the U.K. Bribery Act 2010 has extra-territorial effect for companies and individuals having a connection with the United Kingdom. The U.K.
The anti-bribery provisions of the FCPA are enforced primarily by the Department of Justice. The Securities and Exchange Commission (the “SEC”) is involved with enforcement of the books and records provisions of the FCPA. Similarly, the U.K. Bribery Act 2010 has extra-territorial effect for companies and individuals having a connection with the United Kingdom. The U.K.
Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining 30 regulatory approvals and marketing approved products than we do.
Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Adoptive cell therapy treatments are novel, and any product candidates we develop may be complex and difficult to manufacture.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. 30 Adoptive cell therapy treatments are novel, and any product candidates we develop may be complex and difficult to manufacture.
The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the European Union. The provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of European Union Member States, such as the U.K. Bribery Act 2010.
The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the European Union. The provision of benefits or advantages to 37 physicians is also governed by the national anti-bribery laws of European Union Member States, such as the U.K. Bribery Act 2010.
Our reliance on third parties to conduct future preclinical studies and clinical trials will also result in less direct control over the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff.
Our reliance on third parties to conduct future preclinical studies and clinical trials will also result in less direct control over the management of data developed through preclinical 44 studies and clinical trials than would be the case if we were relying entirely upon our own staff.
If we fail to comply with our obligations 47 under any license, the licensor may have the right to terminate the license, in which event we would not be able to develop or market our cell-based immunotherapies or any other therapies or product candidates covered by the licensed intellectual property.
If we fail to comply with our obligations under any license, the licensor may have the right to terminate the license, in which event we would not be able to develop or market our cell-based immunotherapies or any other therapies or product candidates covered by the licensed intellectual property.
Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects. Our patent, patent applications and any future patents may not provide sufficient protection of our cell-based immunotherapies, our product candidates and our future product candidates or result in any competitive advantage.
Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects. 48 Our patent, patent applications and any future patents may not provide sufficient protection of our cell-based immunotherapies, our product candidates and our future product candidates or result in any competitive advantage.
If any such actions are 57 instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant fines or other sanctions.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant fines or other sanctions.
For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period.
For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at 22 least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period.
Commercialization of our product candidates will require additional preclinical and/or clinical development; regulatory and marketing approval in multiple jurisdictions, including by the FDA and the European Medicines Agency (“EMA”); obtaining manufacturing supply, capacity and expertise; building of a commercial organization; and significant marketing efforts.
Commercialization of our product candidates will require additional preclinical and/or clinical development; regulatory and marketing approval in multiple jurisdictions, including by the FDA and the European Medicines Agency (“EMA”); obtaining manufacturing 24 supply, capacity and expertise; building of a commercial organization; and significant marketing efforts.
While in our trials to date, there have been no observations of neurotoxicity or cytokine release syndrome. There can be no assurance that our 27 product candidates will not cause undesirable side effects in the future, which may include serious adverse effects that are related to our product candidates.
While in our trials to date, there have been no observations of neurotoxicity or cytokine release syndrome. There can be no assurance that our product candidates will not cause undesirable side effects in the future, which may include serious adverse effects that are related to our product candidates.
The full effects of these changes are still unclear because the USPTO continues to promulgate new regulations and procedures in connection with the America Invents Act, and many of the substantive changes to patent law, including the “first-inventor-to-file” provisions, only became effective in March 2013.
The full effects of these changes are still unclear because the USPTO continues to promulgate new regulations and procedures in connection with the America Invents Act, and many of the substantive changes to patent law, including the “first-inventor-to-file” provisions, only became effective 54 in March 2013.
In addition, our proprietary technology and processes may be independently 55 developed by others in a manner that could prevent us from receiving legal recourse. If any of our confidential or proprietary information were to be disclosed or misappropriated, or if any of that information was independently developed by a competitor, our competitive position could be harmed.
In addition, our proprietary technology and processes may be independently developed by others in a manner that could prevent us from receiving legal recourse. If any of our confidential or proprietary information were to be disclosed or misappropriated, or if any of that information was independently developed by a competitor, our competitive position could be harmed.
We have no committed source of additional capital and, if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
We have no committed source of additional capital and, if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to 21 significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
If we are unable to rely on preclinical and clinical data collected by third parties, we could be required to repeat, 44 extend the duration of or increase the size of any preclinical studies or clinical trials we conduct and this could significantly delay commercialization and require greater expenditures.
If we are unable to rely on preclinical and clinical data collected by third parties, we could be required to repeat, extend the duration of or increase the size of any preclinical studies or clinical trials we conduct and this could significantly delay commercialization and require greater expenditures.
Moreover, even if competitors or other third parties do not actively 48 promote their product to treat the indications recited in such patent claims, health care providers may recommend that patients use the competitor products off-label, or patients may do so themselves.
Moreover, even if competitors or other third parties do not actively promote their product to treat the indications recited in such patent claims, health care providers may recommend that patients use the competitor products off-label, or patients may do so themselves.
In either event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.
In either event, we may be required to expend significant time and resources to redesign our technology, product 50 candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.
In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property.
In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related to our current or planned business or research and development or made 55 during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property.
However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned. 23 We cannot be certain that additional funding will be available on acceptable terms, or at all.
However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned. We cannot be certain that additional funding will be available on acceptable terms, or at all.
Federal NOLs generally may not be carried back to prior taxable years except that, under the Coronavirus Aid, Relief, and Economic Securities Act (the CARES Act), federal NOLs generated in 2018, 2019 and 2020 may be carried back to each of the five taxable years preceding the taxable year in which the loss arises.
Federal NOLs generally may not be carried back to prior taxable years except that, under the Coronavirus Aid, Relief, and Economic Securities Act, federal NOLs generated in 2018, 2019 and 2020 may be carried back to each of the five taxable years preceding the taxable year in which the loss arises.
If we were to experience a significant cybersecurity breach of our information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to counter-parties and data subjects could be material. In addition, our remediation efforts may not be successful.
If we were to experience a significant 58 cybersecurity breach of our information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to counter-parties and data subjects could be material. In addition, our remediation efforts may not be successful.
If 32 we successfully develop product candidates, we may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet FDA, EMA or other comparable applicable foreign standards or specifications with consistent and acceptable production yields and costs.
If we successfully develop product candidates, we may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet FDA, EMA or other comparable applicable foreign standards or specifications with consistent and acceptable production yields and costs.
These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees.
These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other 61 employees, which may discourage such lawsuits against us and our directors, officers and employees.
These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, 65 their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
In the future, we may choose to build a 29 focused sales, marketing and commercial support infrastructure to sell, or participate in sales activities with our collaborators for, some of the product candidates we may develop if and when they are approved.
In the future, we may choose to build a focused sales, marketing and commercial support infrastructure to sell, or participate in sales activities with our collaborators for, some of the product candidates we may develop if and when they are approved.
We are unable to 40 predict what additional legislation, regulations or policies, if any, relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future or what effect such legislation, regulations or policies would have on our business.
We are unable to predict what additional legislation, regulations or policies, if any, relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future or what effect such legislation, regulations or policies would have on our business.
The GDPR increases obligations with respect to clinical trials conducted in the EEA, such as in relation to the provision of fair processing notices, responding to data subjects who exercise their rights and reporting certain data breaches to regulators and affected individuals.
The GDPR increases obligations with respect to clinical trials conducted in the EEA, such as in relation to 41 the provision of fair processing notices, responding to data subjects who exercise their rights and reporting certain data breaches to regulators and affected individuals.
Competing products, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for the product candidates we may develop. 45 Some of our collaborators or strategic partners could also become our competitors in the future.
Competing products, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for the product candidates we may develop. Some of our collaborators or strategic partners could also become our competitors in the future.
No assurance can be given that, if challenged, our current or future patents would be declared by a court, patent office or other governmental authority to be valid or enforceable or that even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents.
No assurance can be given that, if challenged, our current or future patents would be declared by a court, patent office or other governmental authority to be valid or enforceable or that 49 even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents.
These established companies may have a competitive advantage over us due to their size, capital resources and 51 greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.
These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.
Such litigation or proceedings could 53 substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.
Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.
Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an 24 “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income.
Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income.
Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which we may obtain approval for the product candidates we may develop.
Any product candidates that we 28 successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which we may obtain approval for the product candidates we may develop.
In addition, Agenus may distribute a portion of the shares of our common stock it currently holds to its stockholders, which could impact our share price or volatility. Agenus owns a significant equity interest in our company.
In 43 addition, Agenus may distribute a portion of the shares of our common stock it currently holds to its stockholders, which could impact our share price or volatility. Agenus owns a significant equity interest in our company.
Although we believe that there are several potential alternative manufacturers who could manufacture any product candidates we may develop, we may incur added costs and delays in identifying and qualifying any such replacement.
Although we believe that there are several 45 potential alternative manufacturers who could manufacture any product candidates we may develop, we may incur added costs and delays in identifying and qualifying any such replacement.
To market and sell any product candidates we may develop in the European Union and other foreign jurisdictions, we or our third-party collaborators must obtain separate marketing approvals (a single one for the European Union) and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing.
To market and sell any product candidates we may develop in the European Union, the United Kingdom, and other foreign jurisdictions, we or our third-party collaborators must obtain separate marketing approvals (a single one for the European Union) and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial 50 conditions, results of operations and growth prospects.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects.
We regularly maintain cash balances at third-party financial institutions, such as Silicon Valley Bank (“SVB”), in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver.
We regularly maintain cash balances at third-party financial institutions, such as Silicon Valley Bank (“SVB”), in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. In March 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver.
We currently utilize business offices, laboratory space and equipment in Agenus’ Lexington, Massachusetts and Oxford, UK facilities and office space in Agenus’ New York City office. Because our operations have not been fully separated from Agenus, we may have difficulty doing so in the future.
We currently utilize business offices, laboratory space and equipment in Agenus’ Lexington, Massachusetts and Cambridge, UK facilities and office space in Agenus’ New York City office. Because our operations have not been fully separated from Agenus, we may have difficulty doing so in the future.
We and our collaborators, if any, may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any product candidates we may identify and develop, including: • delays in reaching a consensus with regulators on trial design; • regulators, institutional review boards (“IRBs”), or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • delays in reaching or failing to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective CROs and clinical trial sites; 33 • clinical trials of any product candidates we may develop may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development or research programs; • difficulty in designing well-controlled clinical trials due to ethical considerations which may render it inappropriate to conduct a trial with a control arm that can be effectively compared to a treatment arm; • difficulty in designing clinical trials and selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • the number of patients required for clinical trials of any product candidates we may develop may be larger than we anticipate, enrollment of suitable participants in these clinical trials may be delayed or slower than we anticipate or patients may drop out of these clinical trials 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; • regulators, IRBs or independent ethics committees may require that we or our investigators suspend or terminate clinical research or clinical trials of any product candidates we may develop for various reasons, including noncompliance with regulatory requirements, a finding of undesirable side effects or other unexpected characteristics, or that the participants are being exposed to unacceptable health risks or after an inspection of our clinical trial operations or trial sites; • the cost of clinical trials of any product candidates we may develop may be greater than we anticipate; • the supply or quality of any product candidates we may develop or other materials necessary to conduct clinical trials of any product candidates we may develop may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of any product candidates we may develop to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • delays in having patients complete participation in a trial or return for post-treatment follow-up; • clinical trial sites dropping out of a trial; • selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data; • occurrence of serious adverse events associated with any product candidates we may develop that are viewed to outweigh their potential benefits; • occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, or additional administrative burdens associated with foreign regulatory schemes; or • failure of ourselves or any third-party manufacturers, contractors or suppliers to comply with regulatory requirements, maintain adequate quality controls or be able to provide sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates.
Any product candidates we develop may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. 31 We and our collaborators, if any, may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any product candidates we may identify and develop, including: • delays in reaching a consensus with regulators on trial design; • regulators, institutional review boards (“IRBs”), or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • delays in reaching or failing to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective contract research organizations ("CROs") and clinical trial sites; • clinical trials of any product candidates we may develop may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development or research programs; • difficulty in designing well-controlled clinical trials due to ethical considerations which may render it inappropriate to conduct a trial with a control arm that can be effectively compared to a treatment arm; • difficulty in designing clinical trials and selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • the number of patients required for clinical trials of any product candidates we may develop may be larger than we anticipate, enrollment of suitable participants in these clinical trials may be delayed or slower than we anticipate or patients may drop out of these clinical trials 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; • regulators, IRBs or independent ethics committees may require that we or our investigators suspend or terminate clinical research or clinical trials of any product candidates we may develop for various reasons, including noncompliance with regulatory requirements, a finding of undesirable side effects or other unexpected characteristics, or that the participants are being exposed to unacceptable health risks or after an inspection of our clinical trial operations or trial sites; • the cost of clinical trials of any product candidates we may develop may be greater than we anticipate; • the supply or quality of any product candidates we may develop or other materials necessary to conduct clinical trials of any product candidates we may develop may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of any product candidates we may develop to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • delays in having patients complete participation in a trial or return for post-treatment follow-up; • clinical trial sites dropping out of a trial; • selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data; • occurrence of serious adverse events associated with any product candidates we may develop that are viewed to outweigh their potential benefits; • occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, or additional administrative burdens associated with foreign regulatory schemes; or • failure of ourselves or any third-party manufacturers, contractors or suppliers to comply with regulatory requirements, maintain adequate quality controls or be able to provide sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 66 Item 1B. Unresolved Staff Comments. None.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 63 Item 1B. Unresolved Staff Comments. None.
Violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and other statutes, including the False Claims Act, and equivalent legislation in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws.
Violation of the FDCA and other statutes, including the False Claims Act, and equivalent legislation in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws.
Some of the factors that may cause the market price of our common stock to fluctuate include: • the success of existing or new competitive product candidates or technologies; • the timing and results of preclinical studies or clinical trials for any product candidates that we may develop; • failure or discontinuation of any of our product development and research programs; • results of preclinical studies, clinical trials or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors; • developments or changing views regarding the use of allogeneic cell therapies; • commencement or termination of collaborations for our product development and research programs; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; 64 • the recruitment or departure of key personnel; • the level of expenses related to any of our research programs, clinical development programs or product candidates that we may develop; • the results of our efforts to develop additional product candidates or products; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or other stockholders; • expiration of market stand-off or lock-up agreement; • variations in our financial results or those of companies that are perceived to be similar to us; • changes in estimates or recommendations by securities analysts, if any, that cover our stock; • changes in the structure of healthcare payment systems; • market conditions in the pharmaceutical and biotechnology sectors; • the ongoing and future impact of the COVID-19 pandemic and actions taken to slow its spread; • general economic, industry and market conditions; and • the other factors described in this “Risk Factors” section.
Some of the factors that may cause the market price of our common stock to fluctuate include: • the success of existing or new competitive product candidates or technologies; • the timing and results of preclinical studies or clinical trials for any product candidates that we may develop; • failure or discontinuation of any of our product development and research programs; • results of preclinical studies, clinical trials or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors; • developments or changing views regarding the use of allogeneic cell therapies; • commencement or termination of collaborations for our product development and research programs; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • the level of expenses related to any of our research programs, clinical development programs or product candidates that we may develop; • the results of our efforts to develop additional product candidates or products; • actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or other stockholders; • expiration of market stand-off or lock-up agreement; • variations in our financial results or those of companies that are perceived to be similar to us; • changes in estimates or recommendations by securities analysts, if any, that cover our stock; • changes in the structure of healthcare payment systems; • market conditions in the pharmaceutical and biotechnology sectors; • general economic, industry and market conditions; and • the other factors described in this “Risk Factors” section.
Our amended and restated certificate of incorporation and by-laws, which became effective upon the closing of our initial public offering, include provisions that: • authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock; • create a classified board of directors whose members serve staggered three-year terms; • specify that special meetings of our stockholders can be called only by our board of directors, the Chairman of our board of directors or our Chief Executive Officer; • prohibit stockholder action by written consent; • establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; • provide that vacancies on our board of directors may, unless and until filled by our stockholders, be filled only by a majority of directors then in office, even though less than a quorum; • provide that our directors may be removed only for cause; • do not permit any stockholder to cumulate votes at any election of directors; • expressly authorized our board of directors to make, alter, amend or repeal our amended and restated by-laws; and • require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated by-laws. 63 These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.
Our amended and restated 60 certificate of incorporation and by-laws, which became effective upon the closing of our initial public offering, include provisions that: • authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock; • create a classified board of directors whose members serve staggered three-year terms; • specify that special meetings of our stockholders can be called only by our board of directors, the Chairman of our board of directors or our Chief Executive Officer; • prohibit stockholder action by written consent; • establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; • provide that vacancies on our board of directors may, unless and until filled by our stockholders, be filled only by a majority of directors then in office, even though less than a quorum; • provide that our directors may be removed only for cause; • do not permit any stockholder to cumulate votes at any election of directors; • expressly authorized our board of directors to make, alter, amend or repeal our amended and restated by-laws; and • require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated by-laws.
Such sales may not be subject to the volume, manner of sale, holding period and other limitations of Rule 144 and, therefore, may adversely impact our stock price or volatility. 43 Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Agenus. Garo H. Armen, Ph.D.
Such sales may not be subject to the volume, manner of sale, holding period and other limitations of Rule 144 and, therefore, may adversely impact our stock price or volatility. Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Agenus. Garo H. Armen, Ph.D. (Chairman of the Board), Jennifer S.
We have devoted substantially all of our efforts and financial resources in building our iNKT cell platform, identifying our current product candidates, conducting preclinical development and initiating clinical trials of agenT-797. Our net loss was $28.0 million and $30.2 22 million for the years ended December 31, 2022 and 2021, respectively.
We have devoted substantially all of our efforts and financial resources in building our iNKT cell platform, identifying our current product candidates, conducting preclinical development and initiating clinical trials of agenT-797. Our net loss was $22.5 million and $28.0 million for the years ended December 31, 2023 and 2022, respectively.
If we or our collaborators are required to conduct additional clinical trials or other testing of any product candidates we may develop beyond those that we currently contemplate, if we or our collaborators are unable to successfully complete clinical trials or other 34 testing of any product candidates we may develop, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our collaborators may: • be delayed in obtaining marketing approval for any such product candidates we may develop or not obtain marketing approval at all; • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; • be subject to changes in the way the product is administered; • be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; • have regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form of a REMS or through modification to an existing REMS; • be sued; or • experience damage to our reputation.
In addition, any delays in completing our clinical trials may increase our costs and slow down our product candidate development and approval process. 32 If we or our collaborators are required to conduct additional clinical trials or other testing of any product candidates we may develop beyond those that we currently contemplate, if we or our collaborators are unable to successfully complete clinical trials or other testing of any product candidates we may develop, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our collaborators may: • be delayed in obtaining marketing approval for any such product candidates we may develop or not obtain marketing approval at all; • obtain approval for indications or patient populations that are not as broad as intended or desired; • obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; • be subject to changes in the way the product is administered; • be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; • have regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form of a REMS or through modification to an existing REMS; • be sued; or • experience damage to our reputation.
We may need to obtain additional licenses from Agenus and others to advance our research or allow commercialization of product candidates we may develop. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all.
We may need to obtain additional licenses from third parties to advance our research or allow commercialization of product candidates we may develop. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all.
The following is a summary of the principal risk factors described in this section: Risks Related to Our Financial Position and Need for Additional Capital • We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. • If we fail to raise capital, we would be forced to delay, reduce, or eliminate certain projects. • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies. • Our short history as an independent company may make it difficult to evaluate the success of our business and to assess our future viability. • Our future ability to utilize certain tax attributes may be limited. • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and its financial condition and results of operations.
The following is a summary of the principal risk factors described in this section: Risks Related to Our Financial Position and Need for Additional Capital • We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. • If we fail to raise capital, we would be forced to delay, reduce, or eliminate certain projects. • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies. • Our short history as an independent company may make it difficult to evaluate the success of our business and to assess our future viability. • Our future ability to utilize certain tax attributes may be limited. • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and its financial condition and results of operations. • Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.
In February and November 2021, we released early data from our clinical trial for ARDS secondary to COVID-19; such interim data, and any future interim data from clinical trials that we may conduct, including the clinical trials for agenT-797 for the treatment of multiple myeloma and in ARDS secondary to COVID-19 and, potentially, other life-threatening infectious diseases, are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
In February 2024, we published data from our clinical trial for ARDS secondary to COVID-19; such interim data, and any future interim data from clinical trials that we may conduct, including the clinical trials for agenT-797 for the treatment of cancer and, potentially, other life-threatening infectious diseases, are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
(Chairman of the Board), Jennifer S. Buell, Ph.D. (President, Chief Executive Officer and Director), Brian Corvese (Director) and Ulf Wiinberg (Director) are all current or former officers and/or directors of Agenus. These individuals own Agenus equity and Agenus equity awards.
Buell, Ph.D. (President, Chief Executive Officer and Director), Brian Corvese (Director) and Ulf Wiinberg (Director) are all current or former officers and/or directors of Agenus. These individuals own Agenus equity and Agenus equity awards.
To date, we have not completed a clinical trial for any of our product candidates. Moreover, there have been only a limited number of clinical trials involving the use of iNKT cells and none involving therapies similar to our therapies. It is impossible to predict when or if any product candidates we may develop will prove safe in humans.
To date, we have completed and published preliminary data from clinical trials for agenT-797. Moreover, there have been only a limited number of clinical trials involving the use of iNKT cells and none involving therapies similar to our therapies. It is impossible to predict when or if any product candidates we may develop will prove safe in humans.
The term of a patent in any particular jurisdiction depends on the law governing patent term in the jurisdiction. In most countries, including the United States, the basic term of a utility patent expires 20 years from the earliest effective non-provisional filing date, if all necessary maintenance fees are paid on time.
In most countries, including the United States, the basic term of a utility patent expires 20 years from the earliest effective non-provisional filing date, if all necessary maintenance fees are paid on time.
Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our primary source of funding prior to our initial public offering was through Agenus. As of December 31, 2022, our cash balance was $19.6 million.
Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our primary source of funding prior to our initial public offering was through Agenus. As of December 31, 2023, our cash balance was $3.4 million.
As of December 31, 2022, we had an accumulated deficit of $110.9 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter.
As of December 31, 2023, we had an accumulated deficit of $133.4 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net 20 losses we incur may fluctuate significantly from quarter to quarter.
It is possible that in one or more future periods our results of operations may be below the expectations of public market analysts and investors, and, as a result of these and other factors, the price of our common stock may fall.
It is possible that in one or more future periods our results of operations may be below the expectations of public market analysts and investors, and, as a result of these and other factors, the price of our common stock may fall. If we are unable to raise the value of our common stock, our securities may be delisted.
Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects.
Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects. Risks Related to Our Relationship with Agenus We may experience difficulty in separating our resources from Agenus.
Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our product candidates could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.
We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our medicines in any jurisdiction, which would materially impair our ability to generate revenue. 35 Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our product candidates could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.
Risks Related to Ownership of Our Common Stock We do not know whether a market for our common stock will be sustained or what the market price of our common stock will be, and, as a result, it may be difficult for you to sell your shares of our common stock.
Risks Related to Ownership of Our Common Stock We do not know whether a market for our common stock will be sustained or what the market price of our common stock will be, we may be delisted from the Nasdaq Capital Market if we are unable to comply with Nasdaq Listing Rules, and, as a result, it may be difficult for you to sell your shares of our common stock.
Even if we do obtain analyst coverage, if one or more of the analysts covering our business downgrade their evaluations of our common stock, the price of our common stock could decline.
If no or few analysts commence coverage of us, the trading price of our common stock would likely decrease. Even if we do obtain analyst coverage, if one or more of the analysts covering our business downgrade their evaluations of our common stock, the price of our common stock could decline.

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Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeRegardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safe ty Disclosures. Not applicable. 67 PAR T II
Biggest changeRegardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safe ty Disclosures. Not applicable. 64 PAR T II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThere has been no material change in our planned use of the net proceeds from the offering as described in our Registration Statement on Form S-1. Item 6. Reserved. 68
Biggest changeThere has been no material change in our planned use of the net proceeds from the offering as described in our Registration Statement on Form S-1.
Item 5. Market for Registrant’s Common Equity, Related Stoc kholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on the Nasdaq Capital Market under the symbol “INKT.” Holders As of March 1, 2023, there were approximately 25 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stoc kholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on the Nasdaq Capital Market under the symbol “INKT.” Holders As of March 1, 2024, there were approximately 193 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

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

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Biggest changeMiNK-215 has demonstrated robust efficacy in NSCLC and melanoma preclinical models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration through tumor stroma. These data and programs were presented at SITC in 2022. These programs are both in preclinical development with investigational new drug application (“IND”) enabling activities underway in 2023.
Biggest changeMiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 has demonstrated efficacy in NSCLC and melanoma preclinical models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration through tumor stroma.
We would cease to be an emerging growth company earlier if we have more than $1.07 billion in annual revenue, we have more than $700.0 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1.0 billion of non-convertible debt securities over a three-year period.
We would cease to be an emerging growth company earlier if we have more than $1.235 billion in annual revenue, we have more than $700.0 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1.0 billion of non-convertible debt securities over a three-year period.
As of December 31, 2022, we had received $881,000 of the grant portion and $5.2 million of the advance. During 2020, we discontinued research efforts related to this program, and in 2021 we provided additional information as requested by the Walloon Region to terminate the agreement.
As of December 31, 2023, we had received $881,000 of the grant portion and $5.2 million of the advance. During 2020, we discontinued research efforts related to this program, and in 2021 we provided additional information as requested by the Walloon Region to terminate the agreement.
Historical Results of Operations For the Year Ended December 31, 2022 Compared to the Year Ended December 31, 2021 Research and development (“R&D”) expense R&D expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs.
Historical Results of Operations For the Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022 Research and development (“R&D”) expense R&D expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs.
We recognized the grant portion received as income during the years ended December 31, 2019 and 2020. We learned in the second quarter of 2022 that the Walloon Region had obtained a default judgment in the amount of €2,086,711.91 for repayment of the advance.
We recognized the grant portion received as income during the years ended December 31, 2019 and 2020. We learned in the second quarter of 2022 that the Walloon Region had obtained a default judgment in the amount of €2,086,712 for repayment of the advance.
Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies . 72
Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies . 69
We commenced a Phase 1 clinical trial of agenT-797 for the treatment of multiple myeloma and reported that agenT-797 was tolerable to 1x109 cells/dose and suppressed biomarkers associated with disease progression at SITC in 2022.
In addition, we completed a Phase 1 clinical trial of agenT-797 for the treatment of multiple myeloma and reported at SITC in 2022 that agenT-797 was tolerable to a billion cells/dose and suppressed biomarkers associated with disease progression.
Other income (expense), net Other income increased $2.5 million for the year ended December 31, 2022, from income of $0.2 million for the year ended December 31, 2021 to income of $2.7 million for the year ended December 31, 2022, due to the recognition of a $2.7 million gain on the partial forgiveness of the advance received under our research and development agreement with the Belgium Walloon Region Government (the “Walloon Region”), in the year ended December 31, 2022.
Other income (expense), net Other income decreased $2.7 million for the year ended December 31, 2022, from income of $2.7 million for the year ended December 31, 2022 to de minimis expense for the year ended December 31, 2023, due to the recognition of a $2.7 million gain on the partial forgiveness of the advance received under our research and development agreement with the Belgium Walloon Region Government (the “Walloon Region”), in the year ended December 31, 2022.
“Risk Factors” of this Annual Report on Form 10-K. 71 Critical Accounting Policies and Estimates The SEC defines “critical accounting policies” as those that require the application of management’s most difficult, subjective, or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods.
Critical Accounting Policies and Estimates The SEC defines “critical accounting policies” as those that require the application of management’s most difficult, subjective, or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods.
Liquidity and Capital Resources We have incurred annual operating losses since inception, and we had an accumulated deficit of $110.9 million as of December 31, 2022.
Liquidity and Capital Resources We have incurred annual operating losses since inception, and we had an accumulated deficit of $133.4 million as of December 31, 2023.
Overview We are a clinical stage biopharmaceutical company pioneering the discovery, development and manufacturing of allogeneic, off-the-shelf invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (“NK”) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (“GvHD”).
(“we,” “us” and “our”) is a clinical-stage biopharmaceutical company pioneering a novel platform of living medicines based on a rare and potent class of immune cells called invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (“NK”) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (“GvHD”).
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Overview MiNK Therapeutics, Inc.
In view of the default judgment, we reduced the recorded liability and recorded a gain of approximately $2.7 million in our consolidated statement of operations for the year ended December 31, 2022.
In view of the default judgment, we reduced the recorded liability and recorded a gain of approximately $2.7 million in our consolidated statement of operations for the year ended December 31, 2022. We have included the remaining balance of $2.3 million in other current liabilities in our condensed consolidated balance sheet at December 31, 2023.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. Our Phase 1 clinical trial studying agenT-797 in solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab, is currently advancing as a priority program.
Our Phase 1 clinical trial studying agenT-797 in solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab, is currently advancing as a priority program.
This POC phase 1 underscores the potential application of INKTs in multiple myeloma and establishes important novel data to support the advancement of our armored BCMA-CAR-INKT program as a potential best in class next generation allogeneic BCMA cell therapy for these patients. Strategic discussions to advance this program are underway.
This proof of concept Phase 1 underscores the potential application of INKT cells in multiple myeloma and we believe supports the advancement of our armored B cell maturation antigen (“BCMA”)-CAR-INKT program as a potential best in class next generation allogeneic BCMA cell therapy for these patients. Strategic discussions to advance this program are underway.
General and administrative (“G&A”) expense G&A expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense increased 69% to $7.8 million for the year ended December 31, 2022 from $4.6 million for the year ended December 31, 2021.
These decreases were partially offset by increased personnel costs associated with increased headcount. General and administrative (“G&A”) expense G&A expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreased 5% to $7.4 million for the year ended December 31, 2023 from $7.8 million for the year ended December 31, 2022.
For the years ended December 31, 2022 2021 Payroll and personnel costs $ 5,729,235 $ 3,346,853 Professional fees 11,607,709 6,761,139 Allocated services 1,284,920 1,377,456 Materials and other 4,493,259 2,480,920 Total $ 23,115,123 $ 13,966,368 70 Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market.
Research and Development Programs R&D program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions. 67 For the years ended December 31, 2023 2022 Payroll and personnel costs $ 6,814,210 $ 5,729,235 Professional fees 5,283,439 11,607,709 Allocated services 500,280 1,284,920 Materials and other 2,892,068 4,493,259 Total $ 15,489,997 $ 23,115,123 Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market.
Interest income (expense), net Interest income for the year ended December 31, 2022 was $253,000 due to interest earned on our money market funds. Interest expense related to the Note was $2.4 million for the year ended December 31, 2021.
Interest income (expense), net Interest income increased $210,000 for the year ended December 31, 2023, from income of $253,000 for the year ended December 31, 2022 to income of $463,000 for the year ended December 31, 2023, primarily due to increased interest earned on our money market funds.
Our research and development expenses for the years ended December 31, 2022 and 2021 were $23.1 million and $14.0 million, respectively. We have incurred losses since our inception. As of December 31, 2022, we had an accumulated deficit of $110.9 million. We expect to continue to incur operating losses and negative cash flows for the foreseeable future.
Our research and development expenses for the years ended December 31, 2023 and 2022 were $15.5 million and $23.1 million, respectively. We have incurred losses since our inception. As of December 31, 2023, we had an accumulated deficit of $133.4 million.
R&D expense increased 66% to $23.1 million for the year ended December 31, 2022 from $14.0 million for the year ended December 31, 2021. This increase is primarily due to an increase in costs associated with the advancement of our clinical trials, increased preclinical activities and increased personnel costs associated with internalization of our manufacturing activities.
R&D expense decreased 33% to $15.5 million for the year ended December 31, 2023 from $23.1 million for the year ended December 31, 2022. This decrease is primarily due to decreased costs associated with the timing of our clinical trials and decreased costs associated with allocated Agenus services.
Please see the “Note Regarding Forward-Looking Statements” of this Annual Report on Form 10-K and the risks highlighted under Part I-Item 1A.
Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, and our ability to enter into collaborations. Please see the “Note Regarding Forward-Looking Statements” 68 of this Annual Report on Form 10-K and the risks highlighted under Part I-Item 1A. “Risk Factors” of this Annual Report on Form 10-K.
There are currently no approved therapies for ARDS; our data contribute favorably as a potential therapeutic and we plan to externally finance the advancement of agenT-797 in viral ARDS through strategic collaborations. Discussions are underway. In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs.
There are currently no approved therapies for ARDS and secondary infections are a significant 66 contributor to comorbidity and death in intensive care units; our data contribute favorably as a potential therapeutic and we plan to advance agenT-797 in viral ARDS through strategic collaborations and non-dilutive external financing.
Encouraging early activity was seen with agenT-797 monotherapy and combination, with reductions in target and non-target lesions or disease stabilization in patients, which was presented at Society of Immunotherapy for Cancer (“SITC”) in 2022. We currently expect to have updated readouts from this clinical trial in 2023.
Encouraging activity was seen with agenT-797 monotherapy and combination, with durable responses and disease stabilization in patients, which was presented at the American Association for Cancer Research and more recently at the Society of Immunotherapy for Cancer (“SITC”) conference in November 2023.
This increase is primarily due to increased personnel costs, including stock-based compensation expense, and increased professional fees, primarily attributable to additional legal, strategy, audit and tax and insurance fees.
This decrease is primarily due to decreased professional fees, primarily attributable decreased legal and consulting fees, and decreased costs associated with allocated Agenus services. These decreases were partially offset by increased personnel costs, including stock-based compensation expense, associated with increased headcount.
Our two most advanced engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen (“BCMA), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies.
We are also advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced engineered programs are (1) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT and (2) MiNK-413, an IL-15 armored CAR-iNKT program targeting BCMA program.
Based on our current plans and projections, we believe our year-end cash balance will be sufficient to satisfy our liquidity requirements for more than one year from 69 when these financial statements were issued. Management continues to monitor our liquidity position and will adjust spending as needed in order to preserve liquidity.
We believe that our cash and cash equivalents balance along with the additional funding received subsequent to year end from our parent, Agenus, and funding planned from a third party will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued.
Underwriting discounts, commissions and other offering expenses, were approximately $6.2 million, resulting in net proceeds of approximately $39.8 million. Prior to our initial public offering, we had been reliant on Agenus to finance our operations. From our inception through our initial public offering in October 2021, we received funding of $45.5 million from Agenus through the Note.
Underwriting discounts, commissions and other offering expenses, were approximately $6.2 million, resulting in net proceeds of approximately $39.8 million.
With the unique circumstances of the COVID-19 pandemic, we commenced a Phase 1 clinical trial of agenT-797 in viral ARDS and reported an encouraging survival benefit of 70%, compared to ~10-22% in an in-hospital control and time-matched data from the CDC.
We reported an encouraging survival benefit of 75%, compared to ~10-22% in an in-hospital control and time-matched data from the Centers for Disease Control and Prevention. Notably, in addition to a survival benefit, we reported observations that agenT-797 improved lung function and significantly reduced inflammation and secondary infections in the population.
Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) securing debt financing and/or (3) selling equity securities. If additional funding is not obtained through these sources we have the ability to borrow certain funds from our parent company.
Potential sources of additional funding include: (1) seeking strategic partnerships and collaborations, as well as out-licensing opportunities, for our portfolio programs and product candidates, (2) exploring avenues for securing non-dilutive financing, such as grants and collaborations to strengthen our balance sheet, and (3) potential of equity or debt financing options.
Net cash used in operating activities for the years ended December 31, 2022 and 2021 was $18.9 million and $12.8 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, and our ability to enter into collaborations.
If additional funding is not obtained through these sources, Agenus has indicated a willingness to loan us additional funds to finance our operations. Net cash used in operating activities for the years ended December 31, 2023 and 2022 was $15.8 million and $18.9 million, respectively.
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These data were presented at SITC 2022, and we have planned an update from the trial in the first half of 2023 and a formal scientific publication is currently in review.
Added
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. iNKTs are a potent class of immune cells and serve as master regulators of immune response, possessing the killing power of NK cells and the memory of T-cells.
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Our future liquidity needs will be determined primarily by the success of our operations with respect to the progress of our product candidates and key development and regulatory events in the future.
Added
Our proprietary manufacturing platform allows these cells to be infused in billion-fold numbers, arming the immune system against cancer and other life-threatening diseases. We have established and launched in-house iNKT cell manufacturing and product release capacity to supply more than 5,000 doses per year through a U.S. Food and Drug Administration (“FDA”)-cleared scalable, fully closed, and automatic process.
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Change in fair value of convertible affiliated note Change in fair value of convertible affiliated note reflects the result of our fair value measurement of our convertible affiliated note issued to Agenus (the “Note”) at the balance sheet date.
Added
In our Phase 1 clinical trial, most recently presented at SITC 2023, agenT-797 demonstrated a durable clinical benefit and a tolerable safety profile across various heavily pre-treated solid tumors. This includes non-small cell lung cancer (“NSCLC”), testicular cancer, and gastric cancer. Notably, the median progression-free survival (“PFS”) exceeded six months.
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In October 2021, in connection with our initial public offering, the Note was automatically converted into 5,451,958 shares of our common stock and was not outstanding as of December 31, 2022.
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Approximately 30% of patients experienced durable disease stabilization, even in cancers that were refractory to all prior therapies, such as pembrolizumab and nivolumab. This was observed in multiple cancer types, including but not limited to NSCLC and testicular cancer.
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In October 2021, in connection with our initial public offering, the Note was automatically converted into 5,451,958 shares of our common stock and was not outstanding as of December 31, 2022. Research and Development Programs R&D program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions.
Added
Significantly, a patient with metastatic gastric cancer, who had not responded to anti-PD-1 therapy and standard chemotherapy, achieved a partial response when treated with agenT-797 in combination with nivolumab. This response was ongoing at 10 months. The safety profile of agenT-797 was tolerable, both as a standalone treatment and in combination with PD-1 inhibitors.
Removed
The Note had a $45.5 million principal balance, plus accrued and unpaid interest of $6.8 million. In connection of the completion of our initial public offering, the Note was automatically converted into 5,451,958 shares of our common stock and was not outstanding as of December 31, 2022.
Added
Treatment doses up to one billion cells showed no neurotoxicity, dose-limiting toxicities, or severe cytokine release syndrome (above grade 3). Building on these encouraging results, we plan to conduct a randomized phase 1/2 expansion trial.
Removed
We have included the remaining balance of $2.2 million in other current liabilities in our consolidated balance sheet at December 31, 2022 while we continue to evaluate the merits of the Walloon Region’s claim to the amount. Our cash and cash equivalents balance as of December 31, 2022 was $19.6 million.
Added
This trial will assess the efficacy of agenT-797 in combination with standard-of-care chemotherapy and immune therapy (pembrolizumab/nivolumab), with or without Agenus’ multifunctional anti-CTLA-4 agent, botensilimab, in relapsed/refractory gastric cancer. We reported updated data from our Phase 1 clinical trial of agenT-797 in viral acute respiratory distress syndrome (“ARDS”) at the 2023 American Thoracic Society International Conference.
Removed
Based on our current plans and projections we believe this cash balance will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. Management continues to address our liquidity position and will adjust spending as needed in order to preserve liquidity.
Added
These data and programs were presented at SITC in 2022 with more recent translational data presented at the American Society of Cell and Gene Therapy Conference in 2023. Investigational new drug (“IND”) enabling activities are underway we expect to submit an IND to the FDA in 2024.
Removed
Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future.
Added
Our cash and cash equivalents balance as of December 31, 2023 was $3.4 million.
Removed
Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) securing debt financing and/or (3) selling equity securities. If additional funding is not obtained through these sources we have the ability to borrow certain funds from our parent company.
Added
Because the additional funding is influenced by external uncertainties, in accordance with the relevant accounting guidance, we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Annual Report on Form 10-K.
Added
The financial statements have been prepared on a basis that assumes we will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. Management continually monitors our liquidity position and adjusts spending as needed in order to preserve liquidity.

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