What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-30 compared with 2025-03-28 · 24 added, 28 removed, 331 unchanged (14% of the section changed)

7 unchanged sentences

ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals with minimal immune rejection after transplantation.

We have facilities and manufacturing processes that we believe comply with the requirements of current Good Manufacturing Practice (“GMP”) standards as defined by the U.S.

We have manufacturing processes that we believe comply with the requirements of current Good Manufacturing Practice (“GMP”) standards as defined by the U.S.

Code of Federal Regulations and promulgated by the Food and Drug Administration (“FDA”).

1 unchanged sentence

We focus on applications where cell and tissue therapy are already proven but where there is an insufficient supply of functional cells or tissue.

We believe that the most promising potential clinical application of our technology is for neural stem cells (“ISC-hpNSC ® ”) for treatment of Parkinson’s disease and potentially other central nervous system disorders, such as traumatic brain injury, stroke and Alzheimer’s disease.

We believe that the most promising potential clinical application of our technology is for neural stem cells (“ISC-hpNSC®”) for treatment of Parkinson’s disease and potentially other central nervous system disorders, such as traumatic brain injury and stroke.

Our most advanced project is the neural stem cell program for the treatment of Parkinson’s disease.

2 unchanged sentences

In June 2016 we published the results of a 12-month pre-clinical non-human primate study that demonstrated the safety, efficacy and mechanism of action of the ISC-hpNSC®.

In 2017, we began our Phase I trial of ISC-hpNSC®, human parthenogenetic stem cell-derived neural stem cells for the treatment of Parkinson’s disease.

In 2017, we began our Phase 1 trial of ISC-hpNSC®, human parthenogenetic stem cell-derived neural stem cells for the treatment of Parkinson’s disease.

This trial involves three groups, each with four patients, with each group receiving an increasing amount of ISC-hpNSC® via intracerebral transplantation.

5 unchanged sentences

In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose.

The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and Parkinson’s disease symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2.

This trend continued through 24 months where the % OFF-Time in the second cohort dropped by 55% from the initial reading.

The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia.

The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort.

Our therapeutic product candidates will require extensive preclinical and clinical development and may require specific unforeseen licensing rights obtained at substantial cost before regulatory approval may be achieved and the products sold for therapeutic use.

47 unchanged sentences

Parthenogenesis requires that an unfertilized human egg be “activated” by chemical, physical, or other means.

Activation results in a non-viable “parthenote” from which pluripotent parthenogenetic stem cell lines can be derived.

Activation results in a

non-viable “parthenote” from which pluripotent parthenogenetic stem cell lines can be derived.

The cell lines used by ISCO are human parthenogenetic stem cells.

28 unchanged sentences

We have developed a proprietary process based on parthenogenesis for the creation of a new type of stem cell that has shown to exhibit the pluripotency and proliferative benefits of embryonic stem cells yet avoid the use or destruction of fertilized human eggs or embryos.

Furthermore, since parthenogenetic stem cells can be created with immunogenetically identical (“homozygous”) chromosome

pairs, each line has potential to be an immune match for tens of millions of patients.

Furthermore, since parthenogenetic stem cells can be created with immunogenetically identical (“homozygous”) chromosome pairs, each line has potential to be an immune match for tens of millions of patients.

If such cells were to be differentiated into functional mature cells they would, theoretically, be universally applicable across a wide range of medical conditions.

15 unchanged sentences

In June 2016, we published the results of a 12-month pre-clinical non-human primate study, which demonstrated the safety, efficacy and mechanism of action of the ISC-hpNSC®.

In 2017, we dosed four patients in our Phase I trial of ISC-hpNSC®, human parthenogenetic stem cell-derived neural stem cells for the treatment of Parkinson’s disease.

In 2017, we dosed four patients in our Phase 1 trial of ISC-hpNSC®, human parthenogenetic stem cell-derived neural stem cells for the treatment of Parkinson’s disease.

We reported 12-month results from the first cohort and 6-month interim results of the second cohort at the Society for Neuroscience annual meeting (Neuroscience 2018) in November 2018.

14 unchanged sentences

In February 2019, we published the results of the pre-clinical study in Theranostics, a prestigious peer-reviewed medical journal.

in our Parkinson’s disease clinical trial, ISC-hpNSC®, significantly improved TBI-associated motor, neurological, and cognitive deficits without any safety issues.

The publication titled, "Human parthenogenetic neural stem cell grafts promote multiple regenerative processes in a traumatic brain injury model,” demonstrated that the clinical-grade neural stem cells used in our Parkinson’s disease clinical trial, ISC-hpNSC®, significantly improved TBI-associated motor, neurological, and cognitive deficits without any safety issues.

Each of these product candidates will require extensive preclinical and clinical development and may require specific unforeseen licensing rights obtained at substantial cost before any regulatory approval may be achieved and the products sold for therapeutic use.

69 unchanged sentences

(i) academic researchers in universities and privately-funded research organizations;

(ii) government institutions such as the National Institutes of Health, the United States Army, the United States Environmental Protection Agency and others;

(ii) government institutions such as the National Institutes of Health, the United

States Army, the United States Environmental Protection Agency, and others;

and (iii) industrial organizations such as pharmaceutical companies and consumer product companies.

15 unchanged sentences

At December 31, 2025, we held a total of 36 patents.

These patents expire from January 2025 through May 2037.

In addition, we have obtained exclusive worldwide licenses to patents and patent applications from Astellas Pharma.

These patents expire from May 2026 through May 2037.

In addition, we have obtained exclusive worldwide licenses to patents and patent applications from Astellas Pharma Inc.

We believe that our licensed and internally-generated patents provide the intellectual property rights we need to operate in the pluripotent stem cell field and to progress through the stages of creating a therapeutic stem cell product.

18 unchanged sentences

(“Astellas”) for the production of therapeutic products in the fields of diabetes, liver disease, retinal disease, and the creation of research products in all fields.

In February 2013, each of these license agreements was amended and restated, pursuant to which we continue to have rights to Astellas Pharma’s human cell patent portfolio and non-exclusive rights to future developments in the area of diabetes and liver disease, as well as certain rights to patents covering Single Blastomere technology.

In February 2013, each of these license agreements was amended and restated, pursuant to which we continue to have rights to Astellas’s human cell patent portfolio and non-exclusive rights to future developments in the area of diabetes and liver disease, as well as certain rights to patents covering Single Blastomere technology.

A significant feature of the licensed Single Blastomere technology is a method of ethically obtaining human embryonic stem cells that allows us to isolate and differentiate hES stem cells directly from a “blastocyst” without harming the embryo.

7 unchanged sentences

ISCO actively pursues sponsored research agreements with local and international research organizations and has established research collaborations with collaborators from Yale University, University of South Florida, Tulane University, University of California, San Diego, The Scripps Research Institute (La Jolla), and the Sanford Burnham Preby Medical Discovery Institute.

We are in frequent negotiations to develop collaborative research agreements with additional domestic and international research organizations from both the public and private sector.

We are in negotiations to develop collaborative research agreements with additional domestic and international research organizations from both the public and private sector.

These agreements allow us to team up with nationally and internationally known research scientists to study stem cell technologies developed or licensed by ISCO for possible use in therapeutic or research fields.

31 unchanged sentences

Typically, human clinical evaluation involves a time-consuming and costly three-phase process.

In Phase I, clinical trials are conducted with a small number of people to establish safety pattern of drug distribution and metabolism within the body.

In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, possible dosages and expanded evidence of safety.

In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial.

In Phase III, large-scale, multi-center, comparative trials are conducted with patients afflicted with a target disease in order to provide enough data to demonstrate the efficacy and safety required by the FDA.

In Phase 1, clinical trials are conducted with a small number of people to establish safety pattern of drug distribution and metabolism within the body.

In Phase 2, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, possible dosages, and expanded evidence of safety.

In Phase 3, large-scale, multi-center, comparative trials are conducted with patients afflicted with a target disease in order to provide enough data to demonstrate the efficacy and safety required by the FDA.

The FDA closely monitors the progress of each of the three phases of clinical testing;

8 unchanged sentences

This was a necessary step in the process of eventually advancing stem cell therapies based on ISCO’s core technology into clinical development.

Although the Phase I trial for the Parkinson’s Disease program is anticipated to be conducted in Australia, and therefore not subject to FDA oversight, any future studies will likely be carried out in the United States where this approval is necessary.

Although the Phase 1 trial for the Parkinson’s Disease program is anticipated to be conducted in Australia, and therefore not subject to FDA oversight, any future studies will likely be carried out in the United States where this approval is necessary.

In recognition of the challenges that accompany development of cellular therapy (“CT”) products, the FDA has recently initiated an expedited review and approval process for promising investigational CTs.

The first step in the pathway is submission of a request for

Regenerative Medicine Advanced Therapy (“RMAT”) designation by the sponsor to the FDA, either at the same time as the initial IND filing or by amendment to an active IND (prior to the end-of-phase 2 meeting).

The first step in the pathway is submission of a request for Regenerative Medicine Advanced Therapy (“RMAT”) designation by the sponsor to the FDA, either at the same time as the initial IND filing or by amendment to an active IND (prior to the end-of-Phase 2 meeting).

Upon grant of RMAT designation by the FDA, the sponsor receives access to a number of benefits, the most advantageous of which is early interactions with senior FDA managers for the purpose of discussing potential surrogate or intermediate clinical endpoints to support accelerated approval requirements.

Consideration for accelerated approval, heretofore unavailable to regenerative medicine products, represents a major regulatory advance because it would enable ISCO to market ISC-hpNSC earlier than would be possible through the traditional approval process.

Consideration

for accelerated approval, heretofore unavailable to regenerative medicine products, represents a major regulatory advance because it would enable ISCO to market ISC-hpNSC® earlier than would be possible through the traditional approval process.

European and Other Regulatory Approval

6 unchanged sentences

In Australia, the approval process for commencing Phase 1 and 2 clinical trials resides with Therapeutic Goods Administration (“TGA”) and the Human Research Ethics Committee (“HREC”).

Prior to commencing a clinical trial, a sponsor must submit to TGA a CTX or CTN application and must submit to the HREC a study protocol, an investigator brochure, and a template informed consent for such clinical trial.

Prior to commencing a clinical trial, a sponsor must submit to TGA a Clinical Trial Approval (“CTA”) or Clinical Trial Notification (“CTN”) application and must submit to the HREC a study protocol, an investigator brochure, and a template informed consent for such clinical trial.

The HREC approval process generally takes four to eight weeks.

17 unchanged sentences

Corporate Values and Ethics

The key elements of our corporate value system are described in our Code of Business Conduct Policy (the “Business Code”), which provides uniform guidance to all our employees regarding expectations for proper workplace behavior and ethical decision making.

Our Board of Directors adopted and regularly reviews the Code of Business Conduct, which applies to all of our employees, officers, and directors of the Company.

7 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business