CLDI

Risks Related to Our Business, Financial Position and Capital Requirements We are a biotechnology company with a limited operating history and have not generated any revenue to date from product sales .
We have incurred net losses since our inception, and we had an accumulated deficit of approximately $141.6 million as of December 31, 2025.
For the years ended December 31, 2025 and December 31, 2024, we reported net losses of approximately $20.1 million and $22.2 million, respectively.
We have insufficient cash to continue our operations for the next 12 months and our continued operations are dependent on us raising capital and these conditions give rise to substantial doubt over the Company’s ability to continue as a going concern.
As of December 31, 2025, we had approximately $5.6 million in cash, accumulated deficit of approximately $141.6 million and working capital of approximately $2.3 million.
We believe that our existing cash and cash equivalents as of December 31, 2025, and our anticipated expenditures and commitments for the next twelve months, will not enable us to fund our operating expenses and capital expenditure requirements for the twelve months from December 31, 2025.
Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete our ongoing and planned preclinical studies and clinical trials for our product candidates; ● timely file and receive acceptance of our Investigational New Drug applications (“INDs”), in order to commence our planned clinical trials or future clinical trials; ● successfully enroll subjects in, and complete, clinical trials for our product candidates; ● timely file Biologics License Applications (“BLAs”) and receive regulatory approvals for our product candidates from the FDA and other regulatory authorities; ● initiate and successfully complete all safety studies required to obtain U.S. and foreign marketing approval for our product candidates; ● establish commercial manufacturing capabilities through third-party manufacturers for clinical supply and commercial manufacturing of our product candidates; ● obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates; ● launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; ● maintain a continued acceptable safety profile of the product candidates following approval; ● obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; ● position our products to effectively compete with other therapies; ● obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidates; ● enforce and defend intellectual property rights and claims with respect to our product candidates; and ● hire additional staff, including clinical, scientific and management personnel.
Our enveloped vaccina virus and engineered allogeneic stem cell product candidates represent a novel approach to cancer treatment that creates significant challenges .
We are developing a pipeline of enveloped vaccina virus and allogeneic stem cell product candidates engineered from healthy donor adipose-derived mesenchymal stem cells to potentiate and deliver oncolytic viruses to the tumor site and are intended for use in any patient with certain cancers.
Advancing these novel product candidates creates significant challenges for us, including: ● manipulating and manufacturing our product candidates to required specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● sourcing clinical and, if approved, commercial supplies of adipose and neuronal stem- and other cell types used to manufacture our product candidates; ● understanding and addressing intra-donor variability in the quality and type of donor-derived stem cells, which could ultimately negatively affect our ability to produce a product reliably and consistently, if at all; ● understanding and addressing the sourcing of stem cells for our product candidates; ● educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potential for serious adverse events; ● using medicines to manage adverse side effects or the potential for serious adverse events of our product candidates which may not adequately control such side effects or serious adverse events, and/or may have a detrimental impact on the efficacy of treatment; ● conditioning patients with chemotherapy and possibly checkpoint inhibitors in advance of administering our product candidates, which may increase the risk of adverse side effects or serious adverse events; ● obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with the development and regulation of enveloped vaccina virus and allogeneic stem cell therapies for cancer; and ● establishing sales and marketing capabilities upon obtaining regulatory approval, if any, in order to gain market acceptance of a novel therapy.
We have in-licensed our product candidate CLD-101 for newly diagnosed high grade glioma (“HGG”) that has completed a Phase 1 clinical trial sponsored by Northwestern University.
We have received IND approval from the FDA to initiate a Phase 1 clinical trial for our product candidate CLD-201 that utilizes allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) line VP-001 loaded with tumor selective “CAL1” oncolytic vaccinia virus strain.
Our third program involving enveloping vaccinia virus within a cellular membrane is in IND-enabling studies.
Our future capital requirements will depend on and could increase significantly as a result of many factors, including: ● the scope, progress, results and costs of product discovery, preclinical and clinical development, laboratory testing and clinical trials for the development of our product candidates; ● the timing of, and the costs involved in, obtaining marketing approvals for our product candidates in our initial target indications and our other potential product candidates that we may develop; ● if approved, the costs of commercialization activities for our product candidates for any approved indications or any other product candidate that receives regulatory approval to the extent such costs are not the responsibility of a collaborator that we may contract with in the future, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities; ● the scope, prioritization and number of our research and development programs; ● the costs, timing and outcome of regulatory review of our product candidates; ● our ability to establish and maintain additional collaborations on favorable terms, if at all; ● the achievement of milestones or occurrence of other developments that trigger payments under any additional collaboration agreements we may enter into; ● the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any; ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● the extent to which we acquire or in-license other product candidates and technologies; ● the costs of securing manufacturing arrangements for commercial production; ● the emergence of competing oncolytic viral immunotherapies as well as immuno-oncology therapies in general and other adverse market developments; ● the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates; and Identifying potential product candidates and conducting preclinical development testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales.
Risks Related to Product Development Our business is highly dependent on the success of our RedTail product candidates.
If we are unable to obtain approval for our RedTail product candidates and effectively commercialize any of them for the treatment of patients in its approved indications, our business would be significantly harmed.
Our business and future success depend on our ability to obtain regulatory approval of, and then successfully commercialize, our RedTail product candidates.
CLD-401 is in the early stages of development and has not been administered on human patients.
The preclinical results to date may not predict outcomes for our planned clinical trial or any future studies of CLD-401 or any enveloped virus product candidate.
Because CLD-401 is the first enveloped virus product to be in pre IND studies for the clinic, its failure, or the failure of other enveloped virus therapies, may significantly influence physicians’ and regulators’ opinions regarding the viability of our entire RedTail platform.
Our product candidates will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, a substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales.
In addition, because CLD-401 is our most advanced product candidate from the RedTail platform and our other developing product candidates are based on similar technology, if CLD-401 encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues, or other problems, our development plans and business would be significantly harmed.
Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate the safety and efficacy of our product candidates for use in each target indication through lengthy, complex, and expensive preclinical studies and clinical trials.
Preliminary, top line or interim data from our clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrolment continues, more patient data become available and we issue our final clinical trial report.
The data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.
Additionally, some of past, ongoing and planned clinical trials utilize an “open-label” study design.
Our product candidates are based on a novel approach to the treatment of cancer using vaccinia virus enveloped in a cellular membrane, allogeneic neural stem cell, and allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) loaded with an oncolytic virus which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval, if at all.
We have concentrated all of our research and development efforts on our product candidates, and our future success depends on the successful development of these therapeutic approaches.
CLD-101 for newly diagnosed HGG utilizes NSC-CRAd-S-pk7 , an engineered oncolytic adenovirus delivered by neural stem cells to activate the innate and adaptive immune system.
We expect the novel nature of our product candidates to create significant challenges in obtaining regulatory approval.
While the first viral immunotherapy, talimogene laherparepvec (Imlygic, Amgen), has received FDA approval, regulatory agencies have reviewed relatively few viral immunotherapy product candidates such as our product candidates.
Moreover, the design and conduct of our clinical trials utilizing vaccinia virus enveloped in a cellular membrane and both neural stem cells and adipose-derived mesenchymal stem cells (“AD-MSC”) to deliver oncolytic viruses differs from the design and conduct of previously conducted clinical trials in this area.
The commercial success of adenovirus we use in our CLD-101 product candidates or ACAM2000, a thymidine kinase (TK)-positive strain of vaccinia virus (used as the current smallpox vaccine in the United States) we are using in our CLD-401 and CLD-201 product candidates, will depend in part on public acceptance of the use of immuno-oncology, and, in particular, oncolytic viral immunotherapy.
Adverse events in clinical trials of our current product candidates or vaccinia virus based product candidates which we may develop, or in clinical trials of others developing similar products and the resulting publicity, as well as any other negative developments in the field of immuno-oncology that may occur in the future, including in connection with competitor therapies, could result in a decrease in demand for any adenovirus-, vaccinia virus or ACAM2000-based product candidates that we may develop.
The timing of completion of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrolment.
In particular, because we are focused on patients with brain cancer for the development of CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG, our ability to enroll eligible patients may be limited or enrolment may be slower than we anticipate due to the small eligible patient population.
The enrolment of patients further depends on many factors, including: ● the proximity of patients to clinical trial sites; ● patient referral practices of physicians; ● the design of the clinical trial, including the number of site visits and invasive assessments required; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● our ability to obtain and maintain patient consents; ● reporting of the preliminary results of any of our clinical trials; ● the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and ● factors we may not be able to control, such as the COVID-19 pandemic that limited patient participation, hiring of principal investigators and availability of staff or clinical sites.
We face competition from major pharmaceutical, specialty pharmaceutical and biotechnology companies among others with respect to our product candidates and will face similar competition with respect to any product candidates that we may seek to develop or commercialize in the future.
If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our current and future product candidates as expected, and our ability to generate revenue may be materially impaired.
It is possible that our current and future product candidates will never obtain the appropriate regulatory approvals necessary for us to commence product sales.

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Gone since FY2024

Risks Related to Our Business, Financial Position and Capital Requirements We are an immuno-oncology company with a limited operating history and have not generated any revenue to date from product sales .
We have incurred net losses since our inception, and we had an accumulated deficit of approximately $121.7 million as of December 31, 2024.
For the years ended December 31, 2024 and December 31, 2023, we reported net losses of approximately $22.2 million and $29.2 million, respectively.
Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to: ● successfully complete our ongoing and planned preclinical studies and clinical trials for our allogeneic stem cell delivery of on oncolytic virus programs; ● timely file and receive acceptance of our Investigational New Drug applications, or INDs, in order to commence our planned clinical trials or future clinical trials; ● successfully enroll subjects in, and complete, clinical trials for our oncolytic viral allogeneic stem cell programs; ● timely file Biologics License Applications (“BLAs”) and receive regulatory approvals for our product candidates from the FDA and other regulatory authorities; ● initiate and successfully complete all safety studies required to obtain U.S. and foreign marketing approval for our product candidates; ● establish commercial manufacturing capabilities through third-party manufacturers for clinical supply and commercial manufacturing of our product candidates; ● obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates; ● launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; ● maintain a continued acceptable safety profile of the product candidates following approval; ● obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; ● position our products to effectively compete with other therapies; ● obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidates; ● enforce and defend intellectual property rights and claims with respect to our product candidates; and ● hire additional staff, including clinical, scientific and management personnel.
Our engineered allogeneic stem cell and enveloped vaccina virus product candidates represent a novel approach to cancer treatment that creates significant challenges .
We are developing a pipeline of allogeneic stem cell product candidates engineered from healthy donor adipose-derived mesenchymal stem cells and enveloped vaccina virus to potentiate and deliver oncolytic viruses to the tumor site and are intended for use in any patient with certain cancers.
Advancing these novel product candidates creates significant challenges for us, including: ● manipulating and manufacturing our product candidates to required specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● sourcing clinical and, if approved, commercial supplies of adipose and neuronal stem- and other cell types used to manufacture our product candidates; ● understanding and addressing intra-donor variability in the quality and type of donor-derived stem cells, which could ultimately negatively affect our ability to produce a product reliably and consistently, if at all; ● understanding and addressing the sourcing of stem cells for our product candidates; ● educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potential for serious adverse events; ● using medicines to manage adverse side effects or the potential for serious adverse events of our product candidates which may not adequately control such side effects or serious adverse events, and/or may have a detrimental impact on the efficacy of treatment; ● conditioning patients with chemotherapy and possibly checkpoint inhibitors in advance of administering our product candidates, which may increase the risk of adverse side effects or serious adverse events; ● obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with the development and regulation of allogeneic stem cell and enveloped vaccina virus therapies for cancer; and ● establishing sales and marketing capabilities upon obtaining regulatory approval, if any, in order to gain market acceptance of a novel therapy.
We have in-licensed our lead product candidate CLD-101 for newly diagnosed high grade glioma (“HGG”) that has completed a Phase 1 clinical trial sponsored by Northwestern University.
We intend to initiate a Phase 1b or Phase 2 clinical trial under our in-licensed IND for CLD-101 for patients with newly diagnosed HGG.
We intend to apply for an IND from the FDA and initiate a Phase 1 clinical trial for our product candidate CLD-201 that utilizes allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) line VP-001 loaded with tumor selective “CAL1” oncolytic vaccinia virus strain.
Our third program involves significant preclinical research involving enveloping vaccinia virus within a cellular membrane.
Our future capital requirements will depend on and could increase significantly as a result of many factors, including: ● the scope, progress, results and costs of product discovery, preclinical and clinical development, laboratory testing and clinical trials for the development of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201, and CLD-400 or our other potential product candidates; ● the timing of, and the costs involved in, obtaining marketing approvals for CLD-101 in newly diagnosed HGG, CLD-101 for recurrent HGG as well as for CLD-201 and CLD-400 in our initial target indications and our other potential product candidates that we may develop; ● if approved, the costs of commercialization activities for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG or CLD-201 for any approved indications or any other product candidate that receives regulatory approval to the extent such costs are not the responsibility of a collaborator that we may contract with in the future, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities; ● the scope, prioritization and number of our research and development programs; ● the costs, timing and outcome of regulatory review of our product candidates; ● our ability to establish and maintain additional collaborations on favorable terms, if at all; ● the achievement of milestones or occurrence of other developments that trigger payments under any additional collaboration agreements we may enter into; ● the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any; ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● the extent to which we acquire or in-license other product candidates and technologies; ● the costs of securing manufacturing arrangements for commercial production; ● the emergence of competing oncolytic viral immunotherapies as well as immuno-oncology therapies in general and other adverse market developments; ● the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates; and Identifying potential product candidates and conducting preclinical development testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales.
We may incur significant cash payment obligations under our in-licensing agreements with Northwestern University and City of Hope.
We have entered into certain agreements with Northwestern and City of Hope, in which we are committed to pay up to $10 million in clinical trial costs for CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG.
Furthermore, we have agreed to pay contingent consideration of up to $18.7 million if certain development milestones related to CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG are achieved.
To meet these various cash payment obligations, we may need to sell additional shares of our common stock or other securities or issue debt to raise the required cash, or we may have to divert cash on hand that we would otherwise use for other business and operational purposes, which could cause us to delay or reduce activities in the development and commercialization of our programs and which may have a material adverse effect on our business, operating results and prospects.
Risks Related to Product Development Our business is highly dependent on the success of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201, and CLD-400.
If we are unable to obtain approval for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and/or CLD-400 and effectively commercialize any of these product candidates for the treatment of patients in its approved indications, our business would be significantly harmed.
Our business and future success depend on our ability to obtain regulatory approval of, and then successfully commercialize, our most advanced product candidate, CLD-101 for newly diagnosed HGG.
CLD-101 for newly diagnosed HGG is in the early stages of development and has only been administered to a limited number of patients in a Phase 1 physician-sponsored clinical trial.
The results to date may not predict outcomes for our planned trial or any future studies of CLD-101 for newly diagnosed HGG or any other allogeneic neural stem cell product candidate.
Because CLD-101 for newly diagnosed HGG is the first allogeneic product to be evaluated in the clinic, its failure, or the failure of other allogeneic neural stem cell therapies, may significantly influence physicians’ and regulators’ opinions regarding the viability of our entire pipeline of allogeneic neural stem cell therapies.
We are also dependent on Northwestern University to conduct an additional non-pivotal CLD-101 for newly diagnosed HGG Phase 1 trial in a timely and appropriate manner so that we can sponsor the pivotal Phase 2 trial for CLD-101 for newly diagnosed HGG.
If Northwestern University does not conduct the trial on the timeline we expect, or otherwise fails to support the trial, our leadership position in the allogeneic neural stem cell industry and ability to progress additional product candidates may be significantly harmed.
Our product candidates, including CLD-101 for newly diagnosed HGG, CLD-201 and CLD-101 for recurrent HGG, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, a substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales.
In addition, because CLD-101 for newly diagnosed HGG is our most advanced product candidate and our other product candidates are based on similar technology, if CLD-101 for newly diagnosed HGG encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues, or other problems, our development plans and business would be significantly harmed.
Before obtaining regulatory approvals for the commercial sale of our product candidates, including CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or CLD-400 or any other product candidates we develop, we must demonstrate the safety and efficacy of our product candidates for use in each target indication through lengthy, complex, and expensive preclinical studies and clinical trials.
While we are currently planning for either a physician-sponsored Phase 1b or a company-sponsored Phase 2 clinical trial for CLD-101 for newly diagnosed HGG and are in early stages of clinical development for CLD-101 for recurrent HGG, CLD-201, or CLD-400 it is likely, as is the case with many oncology therapies, that there may be side effects associated with their use.
Preliminary, top line or interim data from our clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, more patient data become available and we issue our final clinical trial report.
These data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.
Additionally, some of past, ongoing and planned clinical trials utilize and “open-label” study design.
Our product candidates are based on a novel approach to the treatment of cancer using allogeneic neural stem cell, allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) loaded with an oncolytic virus, and vaccinia virus enveloped in a cellular membrane which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval, if at all.
We have concentrated all of our research and development efforts on our CLD-101 for newly diagnosed HGG, CLD-201, and CLD-400 product candidates, and our future success depends on the successful development of these therapeutic approaches.
In particular, CLD-101 for newly diagnosed HGG utilizes NSC-CRAd-S-pk7, an engineered oncolytic adenovirus delivered by neural stem cells to activate the innate and adaptive immune system.
We expect the novel nature of our product candidates using allogeneic neural stem cells and allogeneic adipose-derived mesenchymal stem cells (“AD-MSC”) to create significant challenges in obtaining regulatory approval.
While the first viral immunotherapy, talimogene laherparepvec (Imlygic, Amgen), has received FDA approval, regulatory agencies have reviewed relatively few viral immunotherapy product candidates such as CLD-101 for newly diagnosed HGG and CLD-201.
Moreover, the design and conduct of our clinical trials utilizing both neural stem cells and adipose-derived mesenchymal stem cells (“AD-MSC”) and vaccinia virus enveloped in a cellular membrane to deliver oncolytic viruses differs from the design and conduct of previously conducted clinical trials in this area.
The commercial success of adenovirus we use in our CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG product candidates or ACAM2000, a thymidine kinase (TK)-positive strain of vaccinia virus (used as the current smallpox vaccine in the United States) we anticipate using in our CLD-201 product candidate, and the vaccinia virus we intend to utilize in CLD-400 will depend in part on public acceptance of the use of immuno-oncology, and, in particular, oncolytic viral immunotherapy.
Adverse events in clinical trials of CLD-101 for newly diagnosed HGG, CLD-201 or any other adenovirus or any other ACAM2000-based or vaccinia virus based product candidates which we may develop, or in clinical trials of others developing similar products and the resulting publicity, as well as any other negative developments in the field of immuno-oncology that may occur in the future, including in connection with competitor therapies, could result in a decrease in demand for any adenovirus-, vaccinia virus or ACAM2000-based product candidates that we may develop.
The timing of completion of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrollment.

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