What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-20 · 138 added, 94 removed, 703 unchanged (25% of the section changed)

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The United States Adopted Name (USAN) Council adopted zervimesine as the USAN for CT1812 in December 2024.

The company’s initial focus has been on the development of zervimesine for the treatment of Alzheimer’s disease.

The Company’s initial focus was on the development of zervimesine for the treatment of AD.

We believe our evidence demonstrates that zervimesine displaces Aβ oligomers from their neuronal receptors.

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Approximately 7 million people in the United States have been diagnosed with AD, and the World Health Organization estimates that AD affects as many as 35 million people globally.

Enrollment has concluded in the company’s Phase 2 COG0201 (SHINE) study of zervimesine in mild-to-moderate AD.

Top-line results were reported in 2024.

Top-line results from the Company’s Phase 2 COG0201 (SHINE) study of zervimesine in mild-to-moderate AD were reported in 2024.

Enrollment is ongoing in the COG0203 (START) Phase 2 study of zervimesine in patients with Mild Cognitive Impairment (MCI) and early-stage AD.

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Both studies are supported by grant awards totaling $110 million from the National Institute of Aging, or NIA, a division of the National Institutes of Health, or NIH.

In addition, company research produced evidence that zervimesine prevents the binding of ɑ-synuclein to neurons, rescuing cellular function that is compromised in DLB.

The Company research also produced evidence that zervimesine prevents the binding of ɑ-synuclein to neurons, rescuing cellular function that is compromised in DLB.

Based on this information, we conducted the Phase 2 COG1201 (SHIMMER) clinical trial in 130 adults with mild-to-moderate DLB, which concluded in 2024.

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Our clinical trials have been funded by approximately $171 million in cumulative grants awarded primarily by the NIA.

As of October 15, 2024, approximately 477 subjects have received zervimesine in our clinical trials, including people with AD, DLB and dry AMD.

As of October 15, 2025, approximately 782 subjects have received zervimesine in our clinical trials, including people with AD, DLB and dry age-related macular degeneration, or AMD.

Zervimesine has continued to be generally well tolerated and has been granted Fast Track designation by the U.S.

Food and Drug Administration, or FDA, for AD.

Based on proteomic evidence generated from the Company’s clinical programs in Alzheimer’s disease and supported by in vitro findings, the company initiated the Phase 2 COG2201 (MAGNIFY) clinical study of zervimesine for the treatment of geographic atrophy secondary to dry AMD.

Based on favorable results from the AD and DLB programs, and a desire to conserve company resources, the MAGNIFY study was voluntarily concluded in January 2025 after approximately 100 participants were enrolled.

Recent Developments

In 2024, we reported top-line results from both the Phase 2 COG0201 (SHINE) clinical trial, which evaluated zervimesine in 153 adults with mild-to-moderate (MMSE 18-26) AD, and the Phase 2 COG1201 (SHIMMER) clinical trial in 130 adults with mild-to-moderate DLB.

Top-line SHINE results were presented in July 2024 at the Alzheimer’s Association International Conference (AAIC) and additional data from a biomarker-defined population of AD patients from the SHINE study were presented in October 2024 at the Clinical Trials on Alzheimer’s Disease (CTAD) conference.

Top-line results were presented during an investor webinar in December 2024.

Top-line SHIMMER results were presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025.

We initiated the Phase 2 COG2201 (MAGNIFY) clinical study of zervimesine in 2023 based on evidence that zervimesine may be effective in the treatment of GA secondary to dry AMD.

Based on the favorable results from our dementia programs and the need to preserve capital, we made the strategic decision in January 2025 to focus our resources on the development of zervimesine in AD and DLB.

As a result, in February 2025 we voluntarily concluded the MAGNIFY clinical study and began investigator site wind-down procedures.

The conclusion of the study was not the result of any safety concerns.

At the time of the study conclusion, 100 participants had been enrolled in the trial.

Results are being compiled by the contract research organization (CRO) following participant completion of final clinic visits.

We intend to conduct an analysis of the changes in GA lesion size as well as safety and tolerability, which will be reported in the second quarter of 2025.

We continue to believe that zervimesine has the potential to alter the biological processes that contribute to dry AMD.

Our objectives are to develop and advance our portfolio, beginning with our lead product candidate, zervimesine.

We want to leverage our understanding of zeryimesine’s mechanism and its ability to regulate pathways and biological processes.

In January 2026, the Company conducted a Type C meeting with the FDA, with a focus on identifying clinically meaningful endpoints for future DLB studies.

Based on the FDA’s feedback and the strength of its Phase 2 results, the company plans to develop zervimesine for DLB psychosis.

Cognition is planning to meet with the FDA Division of Psychiatry to discuss a DLB psychosis program and align on study design.

In December 2025, the last participant was enrolled in the COG0203 (START) Phase 2 study of zervimesine in patients with MCI and early-stage AD.

Topline results are expected after all participants have completed 18 months of treatment.

In July 2025, the company conducted an end-of-Phase 2 meeting with the FDA to review results of the COG0201 (SHINE) study and discuss proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population.

FDA concurred with the proposed plan to randomize participants to 100 mg of oral zervimesine or placebo daily for at least six months and to enrich the Phase 3 study population with AD patients who have lower plasma p-tau217 at screening.

Cognition has received and is reviewing scientific advice from the European Medicines Agency (EMA) indicating a preference for a longer trial than was proposed.

In June 2025, the company initiated an expanded access program (EAP) for participants with DLB.

Through this open-label EAP (COG1202), participants will be provided with 100 mg of oral zervimesine to take daily for approximately one year.

The first participant was enrolled in June 2025 and the last in December 2025.

The EAP enrolled 32 eligible participants who completed the Phase 2 SHIMMER study as well as additional patients with a diagnosis of mild-to-moderate DLB who met the criteria for this program.

Our primary objective is to develop our lead product candidate, zervimesine.

We want to leverage our understanding of zervimesine’s mechanism and its ability to regulate pathways and biological processes.

The key elements of our strategy include:

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Our COG0203 (START) clinical trial in patients with mild dementia associated with early-stage AD has been funded by a grant of approximately $81 million awarded by the NIA.

● Develop product candidates for other CNS and degenerative diseases, including synucleinopathies .

We intend to develop and advance other product candidates to treat other conditions, potentially including the synucleinopathies, which include Parkinson’s disease (PD) and DLB.

Preclinical data published in February 2021 showed that our candidate’s mechanism may play an integral role in the pathology of DLB and PD, which we believed merited further study.

To that end, we conducted a 130-patient Phase 2 COG1201 (SHIMMER) study of zervimesine in patients with DLB, which was funded primarily through the NIA.

● Prioritize development of zervimeinse for DLB psychosis.

We intend to advance zervimesine for the treatment of DLB psychosis.

Results from a 130-patient Phase 2 COG1201 (SHIMMER) study of zervimesine in patients with DLB showed efficacy signals across symptom domains.

Notable treatment effects were observed in hallucinations and delusions, which are hallmark psychotic symptoms that affect a majority of DLB patients.

The SHIMMER study was funded primarily through the NIA.

● Expand our pipeline through internal development, in-licensing and acquisitions .

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To achieve this objective, we may supplement our internal development initiatives through selective in-licensing arrangements, as well as investments in strategic collaborations, and partnerships which complement our initiatives.

● Optimize the value of zervimesine and other product candidates in major markets.

● Optimize the value of zervimesine in major markets.

We currently retain all worldwide rights to zervimesine for all indications.

We plan to develop and pursue approval of zervimesine and other future product candidates in major markets.

We plan to develop and pursue approval of zervimesine in major markets.

Where appropriate, we may use strategic collaborations or partnerships to accelerate development and maximize the commercial potential of our programs.

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We intend to continue our work with these research institutions and potentially expand to include pharmaceutical partners, advocacy organizations and others to seek additional non-dilutive funding for our clinical development when possible.

Zervimesine for the Treatment of Dementias:

Neurodegenerative diseases including AD and DLB are defined by progressive degeneration of nerve cells, or neurons, which often leads to neuronal death, causing dementia, a progressive decline in memory, language, problem-solving and other cognitive functions, results in decreased quality of life and shorter life span.

Zervimesine Programs

Neurodegenerative diseases including AD and DLB are defined by progressive degeneration of nerve cells, or neurons, which often leads to neuronal death, causing dementia, a progressive decline in memory, language, problem-solving and other cognitive functions, resulting in decreased quality of life and shorter life span.

Two of the most common causes of dementia are AD and DLB.

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COG0203 (START)

The study is enrolling up to 540 participants with MCI or early AD

545 participants with MCI or early AD.

This study has completed enrollment.

mild-moderate

COG0201 (SHINE)

Phase 2 (n=153)

Participants treated with zervimesine experienced a cognitive benefit compared to placebo

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COG0202 (SEQUEL)

Phase 2 (n=16)

Participants treated with zervimesine exhibited improvement across prespecified EEG parameters

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COG0105 (SPARC)

Phase 1 (n=23)

Treatment with zervimesine was assessed using various imaging modalities, including PET imaging and volumetric MRI (vMRI)

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COG0104 (SNAP)

Phase 1 (n=3)

Confirmed preclinical findings showing an increase in Aβ oligomers in CSF, suggesting increased off-rate from receptors

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COG1201 (SHIMMER)

Phase 2 (n=130)

Participants treated with zervimesine experienced benefits across behavioral, functional, cognitive and motor scales

mild-moderate

COG1202 (EAP)

Initially, the EAP will accommodate approximately 30 individuals with DLB.

Currently, fully enrolled.

Geographic Atrophy Secondary to Dry AMD

COG2201 (MAGNIFY)

Participants treated with zervimesine experienced slower growth of their GA lesions over the course of the study

Alzheimer’s Disease (AD)

Zervimesine was designed to selectively target and displace Aβ oligomers bound to neuronal receptors at synapses, a new and differentiated mechanism of action.

Zervimesine was designed to displace Aβ oligomers bound to neuronal receptors at synapses, a new and differentiated mechanism of action.

In our preclinical studies, zervimesine has demonstrated the potential to protect synapses, facilitate their restoration and improve cognitive performance.

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The direct healthcare costs to care for patients with AD and other dementias in the United States is currently estimated to exceed $350 billion and projected to increase to $1 trillion by 2050.

Absent the development of meaningful intervention in the course of the disease, the number of people diagnosed with, and dying from, AD is anticipated to escalate appreciably as lifespans lengthen, since prevalence increases significantly with age.

Absent the development of meaningful

intervention in the course of the disease, the number of people diagnosed with, and dying from, AD is anticipated to escalate appreciably as lifespans lengthen, since prevalence increases significantly with age.

The Centers for Disease Control listed AD as the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older.

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Neurons do not divide or reproduce as part of normal physiological function.

Scientific evidence has demonstrated that Aβ oligomers, formed over time through the buildup of Aβ and its aggregates, bind to specific parts of the synaptic structure and interfere with the normal process of memory formation.

Scientific evidence has demonstrated that Aβ oligomers, formed over time through the buildup of Aβ, bind to specific parts of the synaptic structure and interfere with the normal process of memory formation.

This ligand-like activity confers to Aβ oligomers potent synaptotoxic activity.

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Zervimesine’s Mechanism of Action Prevents Binding of Aβ Oligomers

Our proprietary zervimesine product candidate employs a novel and fundamentally different mechanism compared to other approved or experimental treatments, which facilitates removal of neurotoxic Aβ oligomers through alteration of S2R activity.

Zervimesine, our proprietary product candidate employs a novel and fundamentally different mechanism compared to other approved or experimental treatments, which facilitates removal of neurotoxic Aβ oligomers through alteration of S2R activity.

Experimental evidence suggests that Aβ oligomers likely occupy binding sites contiguous to the S2R complex.

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Zervimesine Clinical Results in AD

We have completed multiple clinical trial evaluations of zervimesine, in both healthy volunteers and patients with mild-to-moderate AD, and have one clinical trial ongoing (START) in patients with MCI or early AD.

We have completed multiple clinical trial evaluations of zervimesine, in both healthy volunteers and patients with mild-to-moderate AD, and have one clinical trial (START) ongoing in patients with MCI or early AD.

The clinical trials we have conducted to date have enabled us to evaluate the safety profile of zervimesine;

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Top-line results were reported in July 2024 with additional data reported in October 2024.

A prespecified analysis conducted on SHINE results identified plasma p-tau217 as a biomarker that may predict an optimal therapeutic response in patients with mild-to-moderate AD.

A prespecified analysis conducted on SHINE results identified plasma p-tau217 as a biomarker that may predict which mild-to-moderate AD patients are likely to respond to zervimesine treatment.

Participants treated with zervimesine (pooled 100 mg and 300 mg) who had baseline levels of plasma p-tau217 below the median of 1.0 pg/mL experienced a 95% reduction of cognitive decline at week 26 as measured by ADAS-Cog 11 relative to placebo-treated participants.

Importantly, this treatment response was observed in participants with below-median p-tau217 levels regardless of their MMSE scores.

Zervimesine was shown to slow cognitive deterioration in people with mild (MMSE 22-26) or moderate (MMSE 18-21) Alzheimer’s disease by 129% and 91%, respectively.

We believe p-tau217 is an important biomarker that has shown the ability to distinguish Alzheimer’s disease from other neurodegenerative disorders with a high degree of accuracy compared to other available biomarkers.

In the overall modified intent-to-treat, or mITT, population in SHINE, participants treated with once-daily oral zervimesine experienced less cognitive decline than those treated with placebo.

As measured with ADAS-Cog 11, zervimesine-treated participants (pooled 100 mg and 300 mg) experienced a mean 38% slowing of decline at six months versus baseline compared to placebo-treated, but did not achieve statistical significance.

As measured with ADAS-Cog 11, zervimesine-treated participants (pooled 100 mg and 300 mg) experienced a mean 38% slowing of decline at six months versus baseline compared to placebo-treated.

There were consistent trends favoring zervimesine in other cognitive measures:

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There were no LFT elevations observed in the 100 mg dose.

Proteomic measurements were also performed on cerebrospinal fluid (CSF) and plasma from these patients, from which we have comprehensive datasets of whole proteome changes observed in AD patients given zervimesine versus placebo for six months.

Proteomic measurements were also performed on cerebrospinal fluid (CSF) and plasma (see below tables) from these patients, from which we have comprehensive datasets of whole proteome changes observed in AD patients given zervimesine versus placebo for six months.

From this, we identified product candidate pharmacodynamic biomarkers that could reflect processes of target engagement, pathway engagement and/or early disease modification.

COG0203 — Phase 2 START Clinical Trial

Our COG0203 study, referred to as START, is a randomized, double-blind, placebo-controlled Phase 2 clinical trial that is currently enrolling 540 patients with early-stage AD and using the Clinical Dementia Rating Scale Sum of Boxes;

or CDR-SB to show a change in the rate of cognitive and functional decline.

We are recruiting patients with MCI due to AD or mild AD who have elevated levels of Aβ as determined by PET imaging or as measured in CSF.

The trial is being conducted in collaboration with ACTC and will utilize approximately 50-60 sites including research sites associated with the consortium, as well as other qualified sites that are not part of the consortium.

Patients will be randomized to receive zervimesine or placebo for 18 months.

Our COG0203 study, referred to as START, is a randomized, double-blind, placebo-controlled Phase 2 clinical trial that has enrolled 545 patients with MCI or early-stage AD.

The Clinical Dementia Rating Scale Sum of Boxes, or CDR-SB, will be used to measure changes in the participants’ rates of cognitive and functional decline.

At the time of enrollment, eligible participants had MCI due to AD or mild AD as well as elevated levels of Aβ as determined by PET imaging or as measured in CSF.

The trial is being conducted in collaboration with ACTC at 45 sites including research sites associated with the consortium, as well as other qualified sites that are not part of the consortium.

Patients have been randomized to receive zervimesine or placebo for 18 months.

In addition to a battery of cognitive and functional measures, we intend to use a variety of biomarkers to measure target engagement and assess changes in neurodegeneration and disease progression.

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five in the 300 mg cohort) and six in the placebo arm.

Zervimesine was well tolerated with similar adverse event rates across treatment arms.

Zervimesine was generally well tolerated with similar adverse event rates across treatment arms.

Most adverse events were mild or moderate in severity with no deaths and no treatment-related SAEs reported.

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Also included as exploratory endpoints were measurement of zervimesine in CSF, and protein expression changes in CSF and plasma.

Zervimesine was well tolerated in the COG0102 study.

Zervimesine was generally well tolerated in the COG0102 study.

All AEs were mild or moderate.

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Following completion of each trial cohort, bioanalytical evaluation of plasma zervimesine PK was conducted.

This trial demonstrated that administration of zervimesine in single doses of up to 1,120 mg, administered once, as well as up to 840 mg of zervimesine dosed for 14 consecutive days was well tolerated.

Significantly, zervimesine concentrations detected in the CSF correlated to an estimated receptor occupancy in the brain of greater than 80%.

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Dementia with Lewy Bodies (DLB)

Substantial cellular and clinical biomarker evidence demonstrate that zervimesine may have a beneficial impact on the pathways impaired in synucleinopathies, namely the localization of α-synuclein aggregates in Lewy bodies, which is a chief hallmark of DLB, Parkinson’s disease (PD) and other synucleinopathies.

More recently, human genetic evidence has linked SNCA, the gene encoding α-synuclein, to the pathology of synucleinopathies.

We have conducted preclinical studies of compounds in our library, including zervimesine, to explore their potential to rescue the biological processes that are impaired in synucleinopathies.

We are currently developing zervimesine for the treatment of DLB.

An Overview of DLB

Substantial cellular and clinical biomarker evidence demonstrate that zervimesine may have a beneficial impact on the pathways impaired in synucleinopathies.

Supportive preclinical evidence shows that zervimesine prevents the binding of ɑ-synuclein oligomers to neurons.

These ɑ-synuclein oligomers have been linked to the progression of Parkinson’s disease and DLB.

Additionally, human genetic evidence has linked SNCA, the gene encoding α-synuclein, to the pathology of synucleinopathies.

An Overview of DLB and DLB Psychosis

DLB is the second most common cause of dementia.

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Increasing evidence suggests that α-synuclein oligomers disrupt key cellular processes including autophagy and elicit neuronal dysfunction and loss of synapses.

DLB is challenging to diagnose and identify as it shares many Alzheimer’s disease symptoms.

DLB is referred to as a “whole-body” disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems.

DLB is challenging to diagnose as it shares many symptoms with Alzheimer’s and Parkinson’s diseases.

DLB is referred to as a “whole-body” disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, behavioral, psychotic, and motor systems.

Varied initial symptoms may include day-to-day fluctuations in alertness level, hallucinations, delusions, movement disorders and REM sleep disorder (acting out dreams while sleeping).

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According to the Lewy Body Dementia Association, the direct healthcare costs for patients with DLB are estimated to be approximately $31 billion per year.

According to a 2025 survey, clinicians, DLB patients, and their care partners ranked behavioral and psychotic symptoms, and activities of daily living among DLB’s most burdensome symptoms.

As many as 80% of patients with DLB will experience psychosis, which impedes daily activities, contributes to higher healthcare costs, and often leads to institutionalization.

While antipsychotics are available for other conditions, none are approved for use in DLB patients.

In fact, many traditional antipsychotics, such as haloperidol, are contraindicated in patients with DLB, who may exhibit severe parkinsonism, sedation, and immobility in response to these medications.

Limitations of Current Treatments

Most approved therapeutic products treat the symptoms of the diseases and modulate dopamine.

While some existing products provide meaningful symptomatic relief, they have significant side effect risks, fail to address the progression of the disease, and over time gradually lose their effectiveness in treating the symptoms of the disease.

There are no currently approved disease-modifying therapeutics for DLB.

Most products that are approved for psychosis in other populations modulate dopamine and are contraindicated in patients with DLB.

Other products exist that can provide meaningful relief for non-psychotic symptoms of DLB, such as attention and sleep disruption, but they have significant side effect risks.

For this reason, neurologists have no treatment options for the majority of DLB patients, who experience these debilitiating symptoms.

In addition, because they fail to address the underlying disease progression, they gradually lose their effectiveness over time in treating the symptoms of the disease.

Rationale for Zervimesine in the Treatment of DLB

The protein α-synuclein is primarily found in neural tissue that plays a role in neurotransmission.

The protein α-synuclein is primarily found in neural tissue and plays a role in neurotransmission.

In DLB, α-synuclein builds up in brain cells and forms oligomers that saturably bind to neurons where they impair critical cellular processes, causing synaptic dysfunction.

Our decision to pursue the treatment of synucleinopathies with zervimesine is based on internal and third-party data, indicating that zervimesine can prevent binding synuclein oligomers and that the S2R components PGRMC1 and TMEM97 regulate cell pathways known to be impaired in synucleinopathies, such as autophagy, vesicle trafficking and lipid synthesis;

Our decision to pursue the treatment of synucleinopathies with zervimesine is based on internal and third-party data, indicating that zervimesine can prevent the binding of synuclein oligomers.

Further evidence indicates that the S2R components PGRMC1 and TMEM97 regulate cell pathways known to be impaired in synucleinopathies, such as autophagy, vesicle trafficking and lipid synthesis;

α-synuclein oligomers bind directly to PGRMC1;

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As these antagonists are selective for the S2R complex, their ability to reverse the effects of α-synuclein on LAMP2A expression provides compelling evidence of the S2R complex’s importance in the regulation of this autophagy pathway.

In vitro analysis further illustrates α-synuclein oligomers’ dose-dependent inhibition of membrane trafficking.

Importantly, oligomer-related inhibition was noted to be four-fold higher than that observed with high concentrations of monomeric α-synuclein, illustrative of the significantly greater toxicity of α-synuclein oligomers.

In vitro analysis further illustrates the impact of α-synuclein oligomers on membrane trafficking.

Oligomers of α-synuclein were found to inhibit intracellular vesicle trafficking, illustrating their toxicity.

Results from this analysis show that oligomers inhibited trafficking significantly more than monomer, corresponding to a measurable four-fold difference in potency as measured by EC50 (middle figure below).

The addition of zervimesine was observed to reverse the membrane trafficking deficit related to the presence of α-synuclein oligomer, while having no effect on membrane activity when dosed in its absence.

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The study met its primary endpoint of safety and tolerability.

Zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI) A-L at the end of the study.

Zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI-12) at the end of the study.

This tool describes the frequency and severity of 12 behavioral symptoms including hallucinations, delusions and anxiety.

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an average of 62% better on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III, a measure of motor function such as gait, balance, and tremor.

COG1202 - Expanded Access Program

The COG1202 expanded access program is an open-label program for eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the enrollment criteria.

Each of the individuals enrolled in the program are being treated with 100 mg of oral zervimesine daily for up to one year.

The program is supported by a donation from the family of a participant in the Phase 2 SHIMMER study.

The first participant was enrolled in COG1202 in July 2025 and enrollment concluded in December 2025.

Other Initiatives

Zervimesine and other chemical structures in our pipeline originate from a screening technique developed by Cognition’s founding scientists.

This screening technique relies on the use of mature primary neuronal cultures designed to replicate the mature brain and its intricate connections and patterns of electrical signaling.

provides us with information-rich measurements more indicative of normal brain function and predicative of functional benefit.

This screening technique relies on the use of mature primary neuronal cultures designed to replicate the mature brain and provide information-rich measurements indicative of normal brain function.

Cognition has generated proprietary small molecule libraries derived from natural chemical scaffolds through a proprietary process which we refer to as conditioned extraction.

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At the time of the discontinuation, 100 participants had been enrolled.

Results are being compiled by the contract research organization (CRO) following participant completion of final clinic visits.

We will conduct an analysis of the changes in GA lesion size as well as safety and tolerability, which will be reported at a later date.

We continue to believe that zervimesine has the potential to alter the biological processes that contribute to dry AMD.

Proposed Synucleinopathies Clinical Program

Subject to additional funding, we may plan to study several next-generation S2R modulators derived from chemically distinct series to measure their ability to rescue cell death in synucleinopathies such as PD and DLB.

We may also study α-synuclein pathology and motor deficits in two mechanistically distinct in vivo models of synucleinopathies.

In parallel, these studies will elucidate the mechanism of action by which S2R modulators are efficacious in PD and DLB and provide essential data to support potential biomarker nomination for PD and DLB.

Additional Product Candidates

Many degenerative disorders are likely to involve a dysfunctional cellular damage response mechanism and significant evidence is emerging which highlights the importance of the S2R complex and its components in regulating this response.

The complex likely contains a number of relevant binding sites that may allow for multiple disease intervention approaches, making it an attractive therapeutic target.

Accordingly, we have engaged in a number of earlier-stage discovery programs which are built upon our identification of five structurally distinct chemical series.

From these series we have multiple leads which will be optimized from each of our lead series.

Each of these leads has demonstrated favorable potency with variable selectivity in early preclinical testing and each of the molecular series possesses distinct bioavailability and PK properties, including differences in half-life and blood-brain and blood-retina permeability.

Topline results from the MAGNIFY study show zervimesine treatment slowed GA lesion growth rates, as measured by slope analysis, by 29% compared to placebo.

The mean change in lesion area, as measured by fundus autofluorescence (FAF), compared to baseline was 28% less for zervimesine-treated participants than for placebo.

A post-hoc segment analysis shows (see below figure) that the reduction in lesion growth increases with length of exposure, from 12.2% between baseline and 6 months to 52.7% between 12 and 18 months.

Zervimesine was generally well tolerated in the MAGNIFY study.

There were no conversions to neovascular AMD, as have been reported with approved complement inhibitors.

There were five instances of treatment-emergent liver enzyme test (“LFT”) increases (greater than 3xULN) that subsided after cessation of drug without evidence of serious liver injury.

Four discontinuations due to AEs occurred in the zervimesine group and three in the placebo group.

No serious AEs were considered related to study drug.

Our Team and Collaborators

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Only costs that are allowable under the grant award, certain government regulations and the NIH’s supplemental policy and procedure manual may be claimed for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time.

While these NIA grants do not contain claw back provisions, the NIA or other government agency may review our performance, cost structures and compliance with applicable laws, regulations, policies and standards and the terms and conditions of the applicable NIA grant.

While these NIA grants do not contain claw back provisions, the NIA or other government agency may review our performance, cost structures and compliance with applicable laws, regulations,

policies and standards and the terms and conditions of the applicable NIA grant.

If any of our expenditures are found to be unallowable or allocated improperly or if we have otherwise violated terms of such NIA grant, the expenditures may not be reimbursed and/or we may be required to repay funds already disbursed.

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These patents complement the regulatory exclusivity by providing the basis for an additional waiting period prior to the FDA’s approval of an abbreviated new drug application, or ANDA, or 505(b)(2) applicant.

If an ANDA or 505(b)(2) applicant were to file its application referencing the NDA for zervimesine before expiration of our composition of matter, pharmaceutical composition, and method of use patents and the applicant asserted that our patents identified on the Orange Book to be invalid or not be infringed, it may be subject to additional waiting periods prior to the FDA’s approval (including a statutory 30-month stay if we sue for infringement, or a shorter period if the patent expires or there are certain settlements or judicial decisions in the patent litigation, starting at the end of the five-year NCE regulatory exclusivity period).

additional waiting periods prior to the FDA’s approval (including a statutory 30-month stay if we sue for infringement, or a shorter period if the patent expires or there are certain settlements or judicial decisions in the patent litigation, starting at the end of the five-year NCE regulatory exclusivity period).

In addition to patent exclusivity, under the provisions of the Hatch-Waxman Act, upon any approval in the United States, we believe that zervimesine will be eligible for five-year NCE regulatory exclusivity, during which time no 505(b)(2) NDA or ANDA can be approved that contains the same active moiety as the chemical entity in the zervimesine NDA.

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Smaller or early-stage companies may also prove to be significant competitors, particularly through sizeable collaborative arrangements with established companies.

These competitors also compete with us in recruiting and retain qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if one or more of our competitors develop and commercialize products that are safer, more effective, better tolerated, or of greater convenience or economic benefit than our proposed product offering.

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As of March 1, 2026, we had 14 employees, 14 of whom were full-time and 8 of whom were engaged in research and development activities.

Seven of our employees hold Ph.D.

Four of our employees hold Ph.D.

None of our employees are represented by a labor union.

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Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug candidate and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug.

In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

In addition, appropriate packaging must be selected and tested, and stability studies conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

While the IND is active and before approval, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination on its ClinicalTrials.gov website.

Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.

Although sponsors are obligated to disclose the results of their clinical trials after completion, disclosure of the results can be delayed in some cases for up to two years after the date of completion of the trial.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government.

Expanded access, sometimes called “compassionate use,” is the use of investigational products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options.

The rules and regulations related to expanded access are intended to improve access to investigational products for patients who may benefit from investigational therapies.

FDA regulations allow access to investigational products under an IND by the company or the treating physician for treatment purposes on a case-by-case basis for:

individual patients (single-patient IND applications for treatment in emergency settings and non-emergency settings);

intermediate-size patient populations;

and larger populations for use of the investigational product under a treatment protocol or treatment IND application.

There is no obligation for a sponsor to make its drug products available for expanded access;

however, as required by the 21st Century Cures Act, or Cures Act, passed in 2016, a sponsor must make its expanded access policy publicly available upon the earlier of initiation of a Phase 2 or Phase 3 trial;

or 15 days after the investigational drug or biologic receives fast track, breakthrough or regenerative medicine advanced therapy designation.

NDA Review and Approval Process

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Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission.

This review typically takes 12 months from the date the NDA is submitted to FDA because the FDA has approximately

two months to make a “filing” decision after the application is submitted.

This review typically takes 12 months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application is submitted.

The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review.

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A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form.

A Complete Response Letter usually describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 clinical trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing.

requirements related to clinical trials, nonclinical studies, or manufacturing.

If a Complete Response Letter is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application.

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In addition, a drug candidate may be eligible for accelerated approval.

Drug candidates intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the drug candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

condition and the availability or lack of alternative treatments.

As a condition of accelerated approval, the FDA generally requires that the sponsor perform adequate and well-controlled post-marketing confirmatory clinical trials which must be conducted with due diligence to verify and describe the predicted clinical benefit.

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Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances.

The FDA does not regulate the behavior of physicians in their choice

of treatments.

The FDA does not regulate the behavior of physicians in their choice of treatments.

The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

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During the NCE exclusivity period, the FDA may not approve or even accept for review an ANDA or an NDA submitted under Section 505(b)(2), or a (505(b)(2) NDA), submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval.

However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed in the Orange Book, with the FDA by the innovator NDA holder.

application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed in the Orange Book, with the FDA by the innovator NDA holder.

Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the Orange Book.

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and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities;

● the Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to certain payments made in the preceding calendar year and other transfers of value provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

applicable manufacturers also are required to report such information regarding payments and transfers of value provided, during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

● the Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to certain payments made in the preceding calendar year and other transfers of value provided to physicians, other licensed healthcare practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Violations of any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and administrative sanctions including penalties, damages, fines, imprisonment, and exclusion from government funded healthcare programs, such as Medicare and Medicaid, and/or adverse publicity.

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The Foreign Corrupt Practices Act, or the FCPA, generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S.

government official in order to influence official action, or otherwise obtain or retain business.

government official in order to influence official

action, or otherwise obtain or retain business.

The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.

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Third-party payors are increasingly challenging the prices charged, examining the medical necessity and reviewing the cost effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy.

Third-party payors may also impose prior authorization requirements, step-therapy protocols, quantity limits, restrictive formularies or preferential tiering for lower-cost therapies, which may delay, limit or prevent patient access to newly approved products.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product.

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There have been significant ongoing efforts to modify or eliminate the Affordable Care Act.

The Tax Act, enacted on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended, or the Code, commonly referred to as the individual mandate.

Other legislative changes have been proposed and adopted since the passage of the Affordable Care Act.

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These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

The Inflation Reduction Act of 2022, or IRA, introduced significant drug pricing reforms that affect Medicare Parts B and D, including the establishment of a drug price negotiation program within the U.S.

Department of Health and Human Services requiring manufacturers of certain selected drugs to charge a negotiated “maximum fair price” or pay an excise tax for noncompliance, the imposition of inflation-based rebate obligations for certain drugs payable under Medicare Parts B and D, and new manufacturer discount obligations under Medicare Part D.

The IRA also capped annual out-of-pocket drug costs for Medicare beneficiaries and redesigned the Medicare Part D benefit, shifting greater financial liability to manufacturers.

Certain provisions of the IRA are being implemented on a phased basis, and substantial penalties may apply for noncompliance.

The ultimate effect of the IRA on our business and the pharmaceutical industry remains uncertain.

There has also been increasing focus on international reference pricing and most-favored-nation , or MFN, pricing models for prescription drugs.

On April 15, 2025, President Trump issued Executive Order 14273 directing the federal government to pursue measures to reduce prescription drug prices, including eliminating the so-called “pill penalty” under the IRA.

On May 12, 2025, President Trump issued Executive Order 14297 directing the Secretary of Health and Human Services to establish and communicate MFN price targets and to pursue rulemaking to impose MFN-based pricing if sufficient progress is not achieved, while also supporting direct-to-patient sales models for manufacturers meeting such targets.

In December 2025, CMS proposed alternative payment models incorporating MFN pricing principles, including the Global Benchmark for Efficient Drug Pricing Model for Medicare Part B and the Guarding U.S.

Medicare Against Rising Drug Costs Model for Medicare Part D, which would require manufacturers of certain drugs to pay additional rebates based on international reference pricing benchmarks.

CMS also introduced the GENErating cost Reductions for U.S.

Medicaid Model, a voluntary MFN-based framework applicable to Medicaid.

These proposals are expected to face legal challenges, and their timing, scope and impact on pricing and reimbursement remain uncertain.

The Affordable Care Act has also been subject to challenges in the courts.

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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