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Item 1. Business

2024-03-08 compared with 2023-03-13 · 312 added, 234 removed, 352 unchanged (61% of the section changed)

Ovid is a biopharmaceutical company that is dedicated to reducing seizures and meaningfully improving the lives of people affected by rare epilepsies and seizure-related neurological disorders.

We believe that epilepsy represents a substantial opportunity, both scientifically and commercially.

Over the last decade, scientific understanding of the underlying biology of neuronal excitability and the pathophysiology of epilepsy has improved.

This understanding of disease, coupled with advances in preclinical research tools, is improving the predictive potential of early research, and thereby, may increase the probability of successful clinical development of anti-seizure medicines ("ASMs").

The large global epilepsy market opportunity reflects the medical and economic potential.

Epilepsy therapeutics today represent an $8 billion market globally, which is expected to grow.

Evidence supporting the opportunity, includes the number of recent acquisitions of epilepsy assets.

These have included acquisitions of rare epilepsy companies with a single, marketed product, which have secured values of greater than one billion dollars.

The unmet need of people affected by seizures remains significant, with approximately three million Americans living with epilepsies today.

Ovid is a biopharmaceutical company that is dedicated to meaningfully improving the lives of people affected by certain epilepsies and brain conditions with seizure symptoms.

We believe that addressing these disorders represents a substantial scientific, medical and commercial opportunity.

Over the last decade, scientific understanding of the underlying biology of neuronal hyperexcitability and the related pathophysiology of epilepsy and many neurological disorders has improved.

This understanding of disease, coupled with advances in preclinical research tools, is improving the predictive potential of translational research, and thereby, may increase the probability of successful clinical development of anti-seizure medicines (“ASMs”).

Emerging science also indicates that addressing the underlying causes of hyperexcitability may have therapeutic applications in broad neurological disease well beyond epilepsy.

The large global epilepsy market opportunity reflects significant unmet medical need and economic potential.

Epilepsy therapeutics today represent an approximately $8 billion market globally.

Evidence supporting the opportunity includes the number of recent acquisitions of epilepsy assets and companies, several of which have been acquired for values greater than $1.0 billion.

The unmet need of people affected by seizures remains significant.

Approximately three million Americans live with epilepsies today and approximately 50 million people suffer from epilepsy worldwide.

We have proven capabilities and expertise in the successful clinical development of ASMs.

We have applied our knowledge to build a differentiated pipeline of medicines with potential first-in-class or best-in-class drug mechanisms of action ("MoA") to treat seizures.

This pipeline has produced two epilepsy programs with potential first-in-class MoAs, and one epilepsy program with a potential best-in-class MoA.

These programs include:

soticlestat, which is a novel cholesterol 24 hydroxylase inhibitor.

Takeda purchased our rights to soticlestat, and is currently evaluating it in two pivotal Phase 3 trials for Dravet syndrome and Lennox Gastaut syndrome.

OV350 is a potential first-in-class direct activator of the KCC2 transporter, and is one among many KCC2 activator compounds in our portfolio.

OV329 is a next-generation GABA aminotransferase ("GABA-AT") inhibitor that we believe has the potential to be best-in-class.

It is currently being evaluated in a Phase 1 study.

Our epilepsy development programs are anticipated to create a range of value-creating milestones in the near- and mid-term for investors.

We have applied our knowledge to build a differentiated pipeline of medicines with potential first-in-class or best-in-class drug mechanisms of action (“MoA”) to treat epilepsies and brain disorders with seizure symptoms.

Our pipeline has produced three programs with potential first-in-class MoAs, and one program with a potential best-in-class MoA.

Currently, three of these programs are in clinical trials in humans.

The fourth is in preclinical studies and is anticipated to advance into human safety studies in 2024.

An overview of these programs includes:

• Soticlestat , a novel cholesterol 24 hydroxylase (“CH24”) inhibitor, which is currently being evaluated in two pivotal Phase 3 trials for Dravet syndrome and Lennox-Gastaut syndrome by Takeda Company Limited (“Takeda”).

Takeda purchased our rights to soticlestat, and is conducting the pivotal trials.

We maintain a significant financial interest in the potential approval and commercialization of soticlestat via potential regulatory and commercial milestones of up to $660.0 million and net sales-based royalty payments from low double digits up to 20%.

We sold a 13% stake in the royalty, regulatory and commercial milestone payments that we are eligible to receive from Takeda to Ligand Pharmaceuticals Incorporated for $30.0 million.

• OV888 (GV101), a highly selective inhibitor of rho associated coiled-coil containing protein kinase 2 (“ROCK2”), which is being developed as a potential first-in-class medicine to treat cerebral cavernous malformations (“CCM”), of which seizures are among common symptoms.

OV888 (GV101) is completing a Phase 1 double-blind, multiple-ascending dose trial and is expected to initiate its Phase 2 program in 2024.

A higher dose cohort has been added to the Phase 1 trial and no serious adverse events have been observed.

• OV329 , a highly potent next-generation GABA-aminotransferase inhibitor (“GABA-AT”), that is thought to potentially deliver preferable seizure reduction and dosing relative to prior medicines in the class.

An oral formulation of OV329 is currently being evaluated in a Phase 1 study that uses biomarkers for efficacy and target engagement.

An intravenous formulation of OV329 is also in development for acute seizures and is expected to enter human safety studies in 2025.

• OV350 , a potential first-in-class direct activator of the central nervous system (“CNS”), specific K-Cl co-transporter (“KCC2”) and is the most advanced of a unique portfolio of drugs leads which are direct KCC2 activator compounds.

Oral and intravenous (“IV”) formulations of several of these compounds have been prepared and have demonstrated activity in multiple preclinical disease models.

We expect to file the first investigational new drug application (“IND”) from this portfolio in 2024.

We believe this portfolio has the potential to deliver multiple INDs over the years to come.

Collectively, these development programs are anticipated to create a range of value-creating milestones in the near- and mid-term for investors.

The Opportunity:

Epilepsies and Seizure-Related Neurological Disorders

Although it is one of the earliest known maladies documented by humanity four millennia ago, today epilepsy remains a common, and often intractable, medical diagnosis.

Epilepsies and Neurological Disorders

Although it is one of the earliest known maladies documented by humanity four millennia ago, epilepsy remains a common, and often intractable, medical diagnosis.

Approximately 50 million people globally experience epilepsy, including an estimated three million adults living with epilepsy in the United States.

While modern drug discovery efforts have produced more than 30 anti-seizure medicines over the last 100 years, a substantial number of epilepsy patients, approximately 30 – 40%, continue to experience damaging breakthrough seizures.

Many of these individuals suffer from rare forms of epilepsies.

While modern drug discovery efforts have produced more than 30 ASMs over the last 100 years, a substantial number of epilepsy patients continue to experience breakthrough seizures that can cause enduring damage to the brain.

Individuals who suffer from rare forms of refractory epilepsies may experience persistent seizure rates ranging from 50 - 90%.

The seizures they suffer can have a devastating impact both upon patients and their families, by triggering permanent motor, cognitive and developmental delays, as well as epileptogenesis, which is a cascade of seizures begetting more seizures.

Some patients with developmental epileptic encephalopathies experience even greater rates of refractory seizures that are resistant to drug therapy.

With an estimated 70% of epilepsy diagnoses occurring in people less than 20 years of age, the need to treat seizures early and effectively is critical to mitigate worsening and permanent later-life disability.

To achieve seizure control, approximately half of patients take a polypharmacy regimen of five or more ASMs, requiring careful management of drug side effects and interactions.

In the search for seizure control, approximately half of patients take a polypharmacy regimen of five or more ASMs, requiring careful management of drug side effects and interactions.

The large population of patients requiring multiple drug therapies to control seizures, and persistent rates of breakthrough seizures, signal the urgent need for effective new medicines.

Scientific progress, including the availability of genetic testing, is illuminating the genetic underpinnings of seizures.

Today, more than 1,000 genes are already associated with epilepsies.

The great unmet medical need and scientific advancements have set the stage for a potential wave of neurotherapeutics, which we believe will be led by anti-seizure medicines.

For these patients, new mechanisms of action that demonstrate improved efficacy, safety and tolerability profiles are optimal, as they may be more easily incorporated into existing treatment regimens without the fear of drug-to-drug interactions (“DDIs”).

Scientific progress, including the availability of genetic testing, improved radiographic scanning tools, and more accurate means of measuring non-seizure symptoms are illuminating the underpinning seizure disorders.

The great unmet medical need and scientific advancements have set the stage for a potential era of neurotherapeutics, which we believe will be led by ASMs.

The Ovid Strategy

The science underlying the discovery and development of new drugs for the brain has changed fundamentally over the last decade.

We believe that major developments in the understanding of the biology of these diseases means that key areas of unmet need, including many epilepsies, are now addressable and offer significant medical and commercial potential.

Our team has proven expertise in understanding MoAs that underlie seizures and shaping potential therapies to

treat rare epilepsies.

This know-how affords us an ability to build Ovid in a manner deeply focused on delivering exciting and successive, novel medicines for epilepsies and seizure-related neurological conditions.

Our strategy is to create sustainable, long-term value by advancing a broad pipeline of anti-seizure medicines.

Our long-term intent is to complement our current pipeline with additional assets via focused business development activities that will eventually form the basis of a fully integrated epilepsy company with multiple commercial medicines and clinical stage programs.

We believe that major developments in the understanding of the biology of these diseases means that key areas of unmet need, including many epilepsies and seizure disorders, are now addressable and offer significant medical potential.

Our team has proven expertise in understanding MoAs that underlie seizures and shaping potential therapies to treat rare epilepsies and disorders with seizures.

Specifically, we have built a pipeline focused on treating the extrinsic or intrinsic causes of neuronal hyperexcitability.

This know-how affords us an ability to build Ovid in a manner focused on delivering successive, novel medicines for epilepsies and seizure-related neurological conditions.

Our strategy is to create sustainable, long-term value by advancing an exciting and differentiated pipeline of small molecules that culminates in a fully integrated neurotherapeutics company with multiple commercial medicines and clinical stage programs.

Over time, we intend to seek to expand our current pipeline of predominantly ASMs to include additional franchises of neurology programs via focused clinical development and business development activities.

This corporate strategy is underpinned by specific research and development, financial and business development strategies.

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In 2021, following encouraging Phase 2 findings, which we delivered six months ahead of schedule, we entered into a Royalty, License and Termination Agreement (“RLT Agreement”) through which we sold back our rights to soticlestat to Takeda.

The RLT Agreement provided us with $196 million paid in Q1 2021 and, if soticlestat is approved and successfully commercialized, we are eligible to receive up to $660 million in sales and regulatory milestones payments and up to 20% of potential net sales-based tiered royalty payments.

The RLT Agreement provided us with $196.0 million paid in Q1 2021 and, if soticlestat is approved and successfully commercialized, we are eligible to receive up to $660.0 million in sales and regulatory milestone payments and low double-digits up to 20% of potential net sales-based tiered royalty payments.

The RLT Agreement provides us with a potential stream of non-dilutive capital.

The funds received from this transaction have enabled us to invest in our organization during a period when we believe the cost of capital would have been unduly expensive.

In 2022, as we committed to our focus on rare epilepsies and seizure-related disorders, we conducted a strategic pipeline and organizational review.

This led to a decision to out-license or terminate non-core programs, which we are in the process of executing.

In addition, we determined and subsequently executed a reshaping of the organization, which led to a workforce reduction of approximately 20%.

Expert Team and Customized Infrastructure

As a result of the strategic changes implemented in 2022, we have built a highly specialized and focused infrastructure that we believe will support us in our chosen area of epilepsies and make us a partner of choice for leading biopharmaceutical companies that wish to pursue valuable drug candidates or research platforms in seizure-related neurological conditions.

This infrastructure spans the critical domains of research, development, delivery and commercial and market access strategy.

We have recruited a diverse team of professionals with subject-matter expertise in seizures and neurological conditions.

The funds received from this transaction have enabled us to invest in and secure what we believe is a world-leading pipeline during a period when we believe the cost of capital would have been unduly expensive.

In 2023, we sold a 13% stake in the royalty, regulatory and commercial milestone payments that we are eligible to receive under the RLT Agreement to Ligand Pharmaceuticals Incorporated (“Ligand”) for $30.0 million.

Our near-term strategy is focused on building a franchise of potential small molecule medicines to treat certain epilepsies and conditions with seizure symptoms.

In alignment with this focus, in 2023, we made the decision to both out-

license and halt certain non-core activities, including several preclinical genetic medicines programs.

For additional information see the section below under the heading “Genetic Research Programs.” We simultaneously streamlined our organization and reduced headcount related mostly to the genetic programs.

Expert Team and Fit-for-Purpose Infrastructure

We have built a highly specialized, efficient, and focused infrastructure that supports us in our chosen area of neurotherapeutics development.

This infrastructure spans the critical domains of research and development, commercial and market access strategy.

Importantly, it positions us to be a potential partner of choice for leading biopharmaceutical companies who wish to pursue valuable drug candidates and research platforms in neurology.

We have recruited a team of professionals with deep subject-matter expertise in seizures and neurological conditions.

This includes epileptologists, physicians, academic scientists, commercial and biopharmaceutical industry leaders.

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Our operational and commercial leaders have extensive experience fostering market access and sales for leading neurological medicines.

In total, our team’s collective professional experience has involved the successful development or commercial launch of 25 CNS medicines, including several epilepsy products.

Our cohesive focus in epilepsies and seizures, reinforced by our professional experience and pipeline of differentiated assets, gives us confidence we can succeed in our mission.

Research & Development Strateg y

We pursue research and development for epilepsies and seizure-related disorders in a manner that is scientifically driven, patient focused, and which is enhanced by business development and academic collaborations.

Whereas some epilepsy developers expressly focus on one biological target, we believe multiple MoAs are needed to treat the heterogeneous causes of seizures.

Accordingly, our pipeline seeks to amass and develop a unique set of compounds and mechanisms that will collectively become a differentiated, leading epilepsy franchise.

Pipeline Focus

We cultivate a pipeline that utilizes a range of potential first-in-class or potential best-in-class MoAs to intercept and mitigate the neuronal excitability that causes seizures.

The pipeline includes novel small-molecules compounds and genetic therapies, including antisense oligonucleotides, to treat rare, genetic seizure disorders.

Collectively, our differentiated pipeline contains multiple potential value-creating drug programs.

Since we were founded in 2014, three potential MoAs to reduce seizures have emerged from our development efforts.

Our portfolio of distinct development programs endeavors to maximize therapeutic opportunities by treating different types of seizures and underlying causes of neuronal hyper-excitability, while simultaneously mitigating potential risks that could occur from unforeseen setbacks associated with any single program.

Our development programs seek to pursue the objective of delivering powerful seizure reduction while also striving for safe and well-tolerated side effect profiles.

For epilepsy patients and clinicians who must regularly manage side effects associated with polypharmacy regimens, it is preferable to have medicines that are well tolerated and exhibit few drug-drug interactions.

Our drug development approach generally seeks rare, resistant epilepsies as initial “sentinel” indications.

Pursuing rare seizure conditions can enable us to demonstrate the rapid proof-of-concept for our compounds in resistant epilepsies, while additionally exploring efficient regulatory pathways and incentives.

Case studies of the life-cycle management for prior anti-seizure medicines suggest that demonstration of refractory seizure reduction is often indicative of therapeutic effect in more common and tractable seizure types.

effective therapeutic outcomes in highly resistant seizures often bodes well for treating conditions with similar, but less severe seizure types.

As the field of anti-seizure medicine advances, we believe connections may be established between the root cause of seizures and other neurological conditions affecting larger populations.

Our strategy focuses initially on evaluating our investigational medicines for pathways and targets impacting rare seizure conditions.

In total, our team’s collective professional experience has involved the successful development or commercial launch of more than 25 CNS medicines, including several epilepsy products.

Our cohesive focus in epilepsies and conditions with seizure symptoms, clear strategy reinforced by our professional experience and pipeline of differentiated assets, gives us confidence we can succeed in our mission.

Research & Development Strategy:

Potential First-In-Class or Best-in-Class Mechanism of Action

Our research and development strategy is focused on designing medicines that can ameliorate neuronal hyperexcitability and return neurons to a state of homeostasis, or “electrophysiological balance.” Many factors can contribute to neuronal hyperexcitability including those extrinsic to the cell such as anatomical abnormalities, trauma, and even infectious disease.

Other factors are intrinsic to the neuron (for example, genetic conditions or the disruption of neuronal metabolism) and others (for example lack of stimulus of the GABA receptor) are caused by imbalances outside the surface of the neuron.

Whatever its origin, imbalance of electrophysiological homeostasis and resultant neuronal hyperexcitability manifests in a range of debilitating neurological conditions, including seizures and epilepsies.

Treatment of epilepsy and seizures today often requires multiple medicines.

Whereas some epilepsy developers expressly focus on one biological target, we believe that until a definitive cure for epilepsy is discovered, multiple MoAs will be needed to successfully treat the heterogeneous causes of seizures.

Accordingly, our pipeline seeks to curate and develop a unique set of compounds that can be effective by itself and/or can provide the necessary intervention to impact multiple mechanisms.

We believe this approach has the potential to provide the basis of a modern differentiated and leading epilepsy franchise.

Core tenets of our approach include a focus on:

• Small molecule compounds.

Ovid’s pipeline is comprised of small molecule programs that can potentially be delivered as a pill, injection, or intravenously.

Recent advances in synthetic methodology, formulation technology, generative artificial intelligence and biology target research have unlocked more opportunities for innovative and creative medicines.

The compounds we seek to develop are brain-permeable and are designed to modulate specific biological targets.

We seek to take advantage of the versatility small molecules have to offer in terms of manufacturing, chemistry, and dosing to potentially deliver novel and next-generation medicines that will make meaningful improvements in the lives of patients.

• Unique biological targets implicated in neuronal regulation.

There is compelling evidence that the novel targets we pursue directly or indirectly modulate hyperexcitability.

These targets are associated with regulating inherent intracellular excitatory/inhibitory balance within neurons.

• Differentiated potential first-in-class or best-in-class mechanisms of action.

We cultivate a pipeline of potential first-in-class or potential best-in-class MoAs to intercept and mitigate the underlying cause of seizures or brain disease.

Collectively, our differentiated pipeline has produced four active potential value-creating drug programs.

Several of these therapeutic development programs (soticlestat, OV888 (GV101) and OV329) seek to affect metabolic, signaling, and enzymatic pathways to modulate extrinsic causes of hyperexcitability, thereby restoring neural balance.

In essence, they seek to change the environment surrounding the neuron.

Our KCC2 mechanisms of action act on the intrinsic excitability of the neuron.

• Sentinel indication clinical development.

Our drug development approach generally pursues rare, resistant conditions as initial “sentinel” indications.

Pursuing rare acute conditions can enable us to demonstrate the rapid proof-of-concept (“POC”) for our compounds, while additionally exploring efficient regulatory pathways and

Case studies of the life-cycle management for prior ASMs suggest that demonstration of refractory seizure reduction is often indicative of therapeutic effect in more common and tractable seizure types.

Similarly, many ASMs were later proven to have clinical efficacy in other neurological conditions.

Simply put, effective therapeutic outcomes in highly pharmaco-resistant indications often bodes well for treating broader neuropathologies.

• Prioritization of the total drug profile.

We strive to develop drug candidates that deliver therapeutic efficacy while maintaining safe and well-tolerated side effect profiles.

As noted above, for neurology patients and clinicians who must regularly manage side effects associated with polypharmacy regimens, it is preferable to have medicines that are well tolerated and exhibit few DDIs.

In addition, we strive to impact the broader symptomatology of disease, including for example, the measurement of behavior and communication change.

As the field of ASM advances, we believe connections may be established between the root cause of hyperexcitability and other neurological conditions affecting larger populations.

These include neuropsychiatric and neuro degenerative disorders and pain.

However, our strategy focuses initially on evaluating our investigational medicines for pathways and targets impacting rare brain conditions.

If effective in rare disease, our intent is to explore expanding on that success to broader conditions of the brain for which the MoA may hold therapeutic relevance.

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We take a scientifically driven approach to identify promising drug candidates for our pipeline.

We are building our portfolio based on the existence of known biological rationales in excitability that are often associated with validated targets, and clear endpoints, such as seizures, for study in clinical trials.

Leveraging our deep understanding of neurology, we identify differentiated MoAs for initial drug candidates.

We are building our portfolio based on the existence of known biological rationales that are associated with targets, and which can be evaluated using validated biomarkers and/or clear endpoints, for study in clinical trials.

As we advance our drug candidates through nonclinical and clinical evaluation, we apply a systematic approach for de-risking compounds using emerging tools, animal models and trial designs.

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• Pursuit of validated and emerging targets.

Because the underlying etiology and presentation of seizures is broad and varied, multiple drug MoAs will continue to be needed to treat epilepsy.

We are building a pipeline of therapeutic development programs representing distinct MoAs, including validated and emerging biological targets in epilepsy.

We seek to target biological pathways or genes for which proof-of-concept has been established via in vitro or animal models.

Additionally, we prioritize targets that are uniquely expressed in the central nervous system, such as:

cholesterol 24 hydroxylase, GABA-AT, and KCC2 co-transporters.

• Blood brain barrier ("BBB") penetrant.

The brain is one of the most difficult organs in the body to treat, in part due to the challenge of penetrating the blood brain barrier.

Ovid’s drug development programs include potential small molecule therapies that demonstrate penetration of the BBB as well as antisense oligonucleotides.

We are building a pipeline of therapeutic development programs representing distinct MoAs, including validated and emerging biological targets in epilepsy and neurovascular disorders such as CCMs.

We seek to target biological pathways or genes for which POC has already been established via in vitro or animal models.

Additionally, we prioritize targets that are either uniquely (1) expressed in the CNS, such as:

CH24 and KCC2 co-transporters or (2) over-expressed in a pathological state, such as ROCK and GABA-AT.

• Blood brain barrier (“BBB”) penetration.

The brain is one of the most difficult organs in the body to treat, in part due to the challenge of penetrating the BBB.

Ovid’s drug development programs include potential small molecule therapies that demonstrate penetration of the BBB.

• Clinically translatable preclinical models .

Recent advances in genetics enable us to employ predictive in vitro and in vivo genetic models of certain epilepsies and seizure-related disorders.

Recent advances in genetics enable us to employ predictive in vitro and in vivo genetic models of specific brain diseases.

We believe these predictive models will allow us to evaluate and observe a drug candidate’s potential activity prior to initiation of human trials.

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Many seizure types afford clear observable endpoints and biomarkers that help capture and measure evidence of the clinical impact of our drug candidates.

Our team of development experts has extensive experience designing scales to measure other symptoms common among seizure-disorders, such as

cognitive declines, movement deficiencies and behavioral manifestations.

Our team of development experts has extensive experience designing scales to measure other symptoms that are common among seizure-disorders, such as cognitive declines, movement deficiencies and behavioral manifestations.

These skills support our desire and ability to develop medicines that may provide a clinical benefit across multiple aspects of patient health.

• Trial design enables early observation of proof-of-concept.

By employing clinical endpoints that are highly relevant and designed to detect meaningful clinical benefits, we anticipate that many of our studies may provide early proof-of-concept in clinical development, thereby directing the use of our capital to projects with higher probability of later-stage success.

By employing surrogate biomarkers and endpoints that are highly relevant and designed to detect meaningful clinical benefits, we anticipate that many of our studies may provide early POC in clinical development, thereby directing the use of our capital to projects with higher probability of later-stage success.

• Motivated and accessible patient populations.

We are targeting our programs for disorders with motivated and accessible patient populations.

We believe that the patients and caregivers affected by epilepsies and seizure disorders have increasing access to diagnostics and genetic testing.

We believe that the patients and caregivers affected by epilepsies and brain disorders have increasing access to diagnostics and genetic testing.

Additionally, many are avid users of social media, through which they learn new insights about their conditions and share relevant information and experiences.

We conduct patient disease community outreach and activities on digital platforms to efficiently identify new patients for our clinical trials, raise disease awareness and help connect with patients and caregivers.

Pipeline Enhanced with Disciplined Business Development & Academic Collaborations

To support our strategy, we plan to enhance and expand our pipeline to include additional indications, therapeutic assets and technologies.

We intend to facilitate our pipeline expansion via two, complementary efforts:

Pipeline Enhanced by Academic Collaborations and Disciplined Business Development

To support our strategy we continue to enhance and expand our pipeline via two complementary efforts:

(1) internal research and development efforts in collaboration with external leaders in the field and academic collaborators;

and (2) business development activities to in-license or partner assets in our chosen area of seizures.

Ovid conducts limited internal drug discovery, which helps us maintain lower costs for laboratory facilities.

Instead, we seek to identify compounds with what we believe is untapped value sitting in other organizations’ pipelines and look to in-license or enter into collaborative agreements to secure such assets and advance clinical development.

and (2) business development activities to partner assets that have promising potential in and outside our chosen therapeutic areas.

Ovid conducts focused internal drug discovery, which helps us maintain lower costs for laboratory facilities.

We identify compounds with what we believe is untapped value sitting in other organizations’ pipelines and look to in-license or enter into collaborative agreements to secure such assets and advance clinical development.

This strategy directs our efforts where we excel at creating value, which is specifically shaping translational and clinical-stage development in our therapeutic area.

An integral part of our process is establishing collaborations with academic research centers to support translational expertise for our programs.

An integral part of our process is establishing collaborations with academic research centers to support translational expertise for our programs, including the Stephen Moss Lab of Neuropharmacology at Tufts University.

The multiple programs in our diversified pipeline create optionality to pursue disciplined business development to expand our opportunities.

As the pipeline progresses, we may endeavor to partner the development of our compounds in non-core indications or extend regional market rights outside the United States.

We believe that we are well positioned to execute on our business development strategy due to the extensive experience and networks of our management team.

Specifically, members of our executive team have had extensive business development careers in the biopharmaceutical industry.

Collectively, our senior management has transacted hundreds of in-licensing deals and collaborations.

Patient-Focused

Ovid is developing product candidates that we believe have the potential to transform the lives of individuals affected by epilepsies and related neurological disorders.

We believe that our therapeutic candidates may be able to meaningfully reduce harmful seizures, mitigate burdensome symptoms, and potentially alter the progression of disease, especially if they can be administered early in life in progressive epilepsy conditions.

Ovid is developing product candidates that we hope will create new possibilities and more good days for people living with rare epilepsies and brain conditions.

For example, we believe that our therapeutic candidates may be able to meaningfully reduce harmful seizures, mitigate burdensome symptoms, and potentially slow down the underlying progression of disease.

Patient communities are critical to informing every aspect of our approach.

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• develop close relationships with patient communities, caregivers, families, disease foundations and key opinion leaders, to better understand the history of these disorders, raise awareness, identify patients and facilitate enrollment of clinical trials;

• identify clinically meaningful endpoints, including seizures, cognitive and behavioral scales that are based on input from the patient communities and their physicians and caregivers;

• identify clinically meaningful endpoints, including seizures, symptoms, and cognitive and behavioral scales that are based on input from the patient communities and their physicians and caregivers;

• develop digital capabilities to be deeply informed and engaged with the patient communities we serve.

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We are focused on delivering long-term value for shareholders.

Our financial strategy seeks to apply our capital in a focused manner to advance a differentiated pipeline of anti-seizure medicines, which we believe may generate multiple value-creating milestones from data and ultimately, commercial sales.

Management believes that we have a sufficient cash runway to fund the operations of Ovid into the first half of 2025.

If soticlestat is successfully approved and commercialized by Takeda, we will be eligible to receive additional capital, via potential milestone payments and royalties.

These potential payments may provide a future source of non-dilutive capital to contribute to funding our operations and business development activities.

Our financial strategy seeks to apply our capital in a focused manner to advance a differentiated pipeline of neurotherapeutics, which we believe may generate multiple value-creating milestones from data and ultimately, commercial sales.

Management believes that we have sufficient cash on hand to fund Ovid's operations into the first half of 2026.

To achieve this cash runway, in October 2023, we sold 13% of our interest in the milestones and royalties that we are eligible

to receive from soticlestat's potential approval and commercialization to Ligand for $30.0 million.

We retain 87% interest in soticlestat's regulatory and commercial milestones and royalties on sales if the drug is successfully approved and commercialized by Takeda.

These future payments may contribute to funding our operations and business development activities.

For additional information, see the description of the Ligand Agreement below under the heading “License and Collaboration Agreements – 2023 Ligand Pharmaceuticals Milestones and Royalties Monetization.”

Ovid Pipeline

Our efforts have already brought drug candidates from proof-of-concept into human clinical trials.

Today, we are one of the few epilepsy-focused companies that has researched and developed three distinct MoAs to target seizures.

We believe this pipeline of potential first-in-class or potential best-in-class mechanisms differentiates us and provides the basis of an attractive franchise of potential small molecule epilepsy medicines.

Our efforts have already brought drug candidates from POC into human clinical trials.

Today, we are one of the few companies that has researched and developed three distinct MoAs to target seizures and one of the only clinical development programs to evaluate a highly selective ROCK2 inhibitor for neurological disease.

The following table (Figure 1) sets forth our drug candidate programs and their development status, MoA, and anticipated near-term milestones:

Ovid Therapeutics Pipeline

Eligible for Financial Stake Due to RLT Agreement with Takeda Pharmaceuticals

We retain significant financial interest in soticlestat, a novel cholesterol 24 hydroxylase (CH24H) inhibitor for the potential treatment of patients with resistant epilepsies, following our role in its successful early and mid-stage development program.

We believe soticlestat has the potential to become a first-in-class compound targeting the metabolism of cholesterol in the brain.

It has been shown to gradually reduce inflammation in the brain as well as indirectly acting on the N-methyl D-aspartate (NMDA) pathway.

Eligible for Non-Dilutive Capital from Takeda Pharmaceuticals

We retain significant financial interest in soticlestat, a novel CH24 inhibitor for the potential treatment of patients with resistant epilepsies, following our role in its successful early and mid-stage development program.

We believe soticlestat has the potential to become a first-in-class medicine targeting the metabolism of cholesterol in the brain.

It has been shown to gradually reduce inflammation in the brain as well as indirectly acting on the N-methyl D-aspartate pathway.

We believe that this dual mechanism plays an important role in modulating excitatory signals involved in epilepsy, and thereby suppressing seizures.

Soticlestat is currently being studied by Takeda Pharmaceuticals in two global, pivotal Phase 3 trials for people with Lennox Gastaut syndrome (LGS) and Dravet syndrome (DS).

Takeda has stated in the first quarter of 2023, that if

these studies are successful, it anticipates submitting new drug applications ("NDAs") to support soticlestat in these indications in its fiscal year 2024 (April 2024 – March 2025).

If soticlestat secures regulatory approval and is commercialized, under the RLT Agreement, we are eligible to receive regulatory and commercial milestones payments of up to $660 million, in addition to potential net sales based tiered royalties of up to 20%.

Soticlestat is currently being studied by Takeda in two global, pivotal Phase 3 trials for people living with Lennox-Gastaut syndrome (“LGS”) and Dravet syndrome (“DS”).

Takeda has stated two pivotal Phase 3 clinical trials studying soticlestat as a treatment for Lennox-Gastaut syndrome and Dravet syndrome completed enrollment, and it anticipates topline data readout by September 2024.

Takeda has stated that it anticipates filing soticlestat for regulatory approval in its fiscal year 2024 (April 2024 – March 2025).

If soticlestat receives regulatory approval and is commercialized, under the RLT Agreement, we are eligible to receive regulatory and commercial milestones payments of up to $660.0 million, in addition to potential net sales based tiered royalties of up to 20%.

In 2023, we sold a 13% stake in the royalty, regulatory and commercial milestone payments that we are eligible to receive under the RLT Agreement to Ligand for $30.0 million.

Royalty payments are eligible on net sales across all regions and all future indications.

The milestones payments do not include an initial upfront payment that we received in March 2021 of $196 million.

The future milestones payments do not include an initial upfront payment that we received from Takeda in March 2021 of $196.0 million.

Background on Takeda Royalty, License & Termination Agreement

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In addition, if soticlestat achieves regulatory approval, and is successfully commercialized, we are eligible to receive up to an additional $660.0 million in regulatory and commercial milestone payments and potential tiered royalties on net sales of soticlestat at percentages ranging from the low double-digits up to 20%, subject to standard reductions in certain circumstances.

Royalties are payable on a country-by-country and product-by-product basis during the period beginning on the date of the first commercial sale of such product in such country and ending on the later to occur of the expiration of patent rights covering the product in such country and a specified anniversary of such first commercial sale.

As a result of this agreement, Takeda secured all the global rights to develop and commercialize soticlestat for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome and Lennox Gastaut syndrome.

Royalties are payable on a country-by-country and product-by-product basis during the period beginning on the date of the first commercial sale of such product and ending on the expiration of patent rights in such country.

As a result of this agreement, Takeda secured all the global rights to develop and commercialize soticlestat for the treatment of developmental and epileptic encephalopathies, including DS and LGS.

In addition, Takeda has assumed responsibility for all development and commercialization costs associated with soticlestat.

We have no ongoing costs or obligations.

OV888 (GV101) – A highly selective ROCK2 inhibitor

In May 2023, we invested in and entered a collaboration with Graviton Bioscience Corporation (“Graviton”) to develop a portfolio of highly selective inhibitors of ROCK2 for the treatment of rare neurological conditions.

The collaboration includes the development of lead program OV888 (GV101), which is a small molecule ROCK2 inhibitor that is currently completing a Phase 1, double-blind multiple-ascending dose trial.

The trial is progressing on track, a higher dose has been added and no serious adverse events have been reported.

For additional information, see the description of the Graviton collaboration agreement below under the heading “License and Collaboration Agreements – 2023 In-licensing and Collaboration Agreement with Graviton Bioscience Corporation.”

OV888 (GV101) is a potent, BBB penetrant inhibitor that is highly selective for ROCK2.

ROCK2 is expressed abundantly in skeletal muscles and in the brain and is believed to primarily function to regulate intracellular cytoskeletal organization.

We believe that the ROCK2 signaling pathway may be hyperactivated in multiple neurological diseases, including disorders involving vascular structures and nerve myelination diseases that can result in seizures, spasms and a variety of other symptoms.

Despite this link, there has been limited clinical development of ROCK2 inhibitors due to challenges penetrating the BBB and the inherent challenge of avoiding inhibition of rho-associated coiled-coil-containing protein kinase 1, which can have unwanted side effects.

The initial indication for OV888 (GV101) is anticipated to be CCM for which there is strong mechanistic evidence for inhibiting ROCK2 (see Figure 2 below).

CCMs are one of the most common intracranial vascular malformation in humans, presenting as mulberry-shaped abnormal blood vessels with thin, leaky walls located in the brain and or spinal cord.

It is thought CCMs affect approximately 1:250 individuals.

At diagnosis, the majority of CCM patients present symptomatically with hemorrhage, focal neurologic deficit and/or seizures, which reflect areas of core competency for our development acumen.

To date, preclinical and human safety studies evaluating OV888 (GV101) have shown it has a favorable toxicology profile with no serious adverse events reported.

We anticipate initiating the Phase 2 program for OV888 (GV101) in the second half of 2024.

Throughout OV888's (GV101) clinical development, we intend to harness the expertise held by the team at Graviton, who previously pioneered the development of Rezurock, the first approved ROCK2 inhibitor for graft vs.

host disease.

Believed mechanism of action for OV888 (GV101) in CCM

OV329 – A next-generation GABA-AT inhibitor

OV329 is an investigational, next-generation GABA-AT inhibitor that we are developing for the treatment of adult and pediatric epilepsy disorders.

OV329 represents a potential best-in-class GABA-AT inhibitor designed to supplant vigabatrin, which is an approved therapeutic in the United States and European Union for the treatment of infantile spasms.

Sabril (vigabatrin) has demonstrated substantial seizure reduction, which led to sales of more than $300 million by Lundbeck in the United States alone.

However, its clinical and commercial use has been limited by lack of a therapeutic window.

OV329 represents a potential best-in-class GABA-AT inhibitor and was designed to supplant vigabatrin, which is an approved therapeutic in the United States and European Union for the treatment of infantile spasms.

Vigabatrin has demonstrated substantial seizure reduction, which led to sales of more than $300 million by Lundbeck in the United States alone.

However, vigabatrin's clinical and commercial use has been limited by lack of a therapeutic window.

Specifically, vigabatrin has generated deleterious ocular effects in some patients, including retinal degradation and irreversible vision loss that led to significant post-market restrictions and monitoring.

We believe OV329 to be an improved GABA-AT inhibitor with a different chemical structure than vigabatrin.

OV329 potentially delivers increased potency and efficiency in the target binding site and has been shown in our preclinical research to be more than 200-fold more potent.

If this preclinical data is confirmed in a clinical setting, we believe that OV329 has the potential to provide (in comparison to vigabatrin):

• seizure reduction efficacy;

• an improved safety profile;

• preferred (lower) dosing.

We believe OV329 to be an improved GABA-AT inhibitor with a different chemical structure, potency and inhibition profile than vigabatrin.

We have observed OV329 to deliver increased potency and efficiency in the target binding site and has been shown in our preclinical research to be more than 200-fold more potent.

We are actively studying two formulations of OV329:

(1) an oral formulation for chronic seizures, which is currently in a Phase 1 trial and 2) an intravenous formulation for acute seizures, which is being readied for an IND (or an equivalent regulatory application) expected in late 2024.

We believe that OV329 has the potential to be therapeutic in refractory and drug-resistant epilepsies such as seizures associated with tuberous sclerosis and refractory status epilepticus (“SE”).

A benefit of our OV329 program is that it acts upon a validated drug target for seizures.

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Given that epilepsy is characterized by excessive neuronal excitation, the increased levels of GABA may suppress this excitatory signaling and may reduce seizures.

Six animal seizure models presented at medical conferences in 2022 demonstrate the seizure reduction potential of OV329 (see Figure 2).

OV329 oral formulation

Based upon preclinical data supporting OV329, we believe that the oral formulation has the potential to provide (in comparison to vigabatrin) preferred (lower) dosing.

We believe that these preclinical data suggests that OV329 could allow for seizure reduction efficacy and improved tolerability in comparison to existing therapeutics.

To support this profile, seven animal seizure models presented at medical conferences in 2022 and 2023 demonstrate the seizure reduction potential of OV329 (see Figure 3 below).

These findings in both chronic and acute seizure models provide additional confidence about the therapeutic potential of OV329 in humans.

Six preclinical models reaffirm OV329 seizure reduction activity, including resistant seizure models

To further support OV329’s potential clinical development, our preclinical efforts sought to extensively characterize its safety and tolerability profile, including any potential ocular effects.

We used a clinically translatable rodent model of albino Sprague-Dawley rats to determine if any ocular changes could be observed associated with the predicted therapeutic doses of OV329 and vigabatrin, as compared to placebo.

Seven preclinical animal models reaffirm OV329 seizure reduction activity, including resistant seizure models

To further differentiate OV329’s potential profile from vigabatrin, our preclinical efforts sought to extensively characterize its safety and tolerability, including any potential ocular effects.

We have demonstrated that the tissue clearance of OV329 is rapid, leading us to believe that the accumulation in the back of the eye may be less likely than vigabatrin, which has a longer half- life.

The pharmaco-dynamic profile of OV329 is also highly differentiated from vigabatrin.

Preclinical research has shown that OV329 induces phasic (synaptic) and tonic (extrasynaptic) inhibition of GABA-AT.

This produced more GABA in the synapse and environmental milieu, potentially contributing to prolonged inhibitory effects.

Additionally, we applied a clinically translatable rodent model of albino Sprague-Dawley rats to determine if any ocular changes could be observed associated with the predicted therapeutic doses of OV329 and vigabatrin, as compared to placebo.

This rodent model is an accepted proxy by the U.S.

FDA for the ocular effects seen in humans treated with vigabatrin.

Figure 3 demonstrates the results of our research.

Food and Drug Administration (“FDA”) for the ocular effects seen in humans treated with vigabatrin.

Figure 3 (below) demonstrates the results of our research.

After 45 days of dosing with the therapeutic dose of vigabatrin and an expected therapeutic dose of OV329 (3 mg/kg), the model showed no ocular effect in animals taking OV329, whereas disruption in retinal cells was seen in animals taking the therapeutic dose of vigabatrin (300 mg/kg).

In this model, OV329’s ocular profile appears similar to placebo, and no disruption to the retina was seen at the anticipated therapeutic dose.

In this short-term model, OV329’s ocular profile appears similar to placebo, and no disruption to the retina was seen at the anticipated therapeutic dose.

These models must be confirmed in human studies, though they lead us to believe that OV329 may offer significant seizure reduction benefit with a therapeutic window not provided by vigabatrin.

No ocular changes seen in rodents treated with expected therapeutic dose of OV329 (3 mg/kg)

In the second half of 2022, our Investigational New Drug Application (IND) for OV329 was cleared by the U.S.

Food and Drug Administration (FDA) and subsequently, we initiated a Phase 1 trial.

That study is currently ongoing at Duke University School of Medicine and will be conducted in two parts, including:

In late 2022, our IND for OV329 was cleared by the FDA and subsequently, we initiated a Phase 1 trial.

That study is currently ongoing at the Nucleus Network at Alfred Hospital in Australia and is expected to complete in the second half of 2024.

The trial is being conducted in two parts, including:

a single-ascending dose and a multiple-ascending dose portion.

Endpoints will evaluate the pharmacokinetic profile, safety, tolerability and target engagement associated with escalating doses of OV329 in healthy volunteers.

We expect to have complete findings of this study in the first half of 2024, including anticipated target engagement levels as measured by magnetic resonance spectrometry (MRS).

Previous studies have reported MRS measurement of GABA concentration levels increase following treatment with

GABA-AT inhibitors, which has been shown to correlate with seizure reduction efficacy in prior GABA-AT inhibitor programs.

Two surrogate biomarkers will be applied in the study, including:

(1) transcranial magnetic stimulation (“TMS”) will be measured and is a corollary for clinical efficacy and (2) magnetic resonance spectrometry (“MRS”) will be used to measure target engagement.

Previous studies have reported MRS measurement of GABA concentration levels increase following treatment with GABA-AT inhibitors, which has been shown to correlate with seizure reduction efficacy in existing GABA-AT inhibitor programs.

If OV329 proves to effectively engage the target and exhibits a tolerable safety profile in the Phase 1 study, these metrics may inform mid-to-late-stage development of the program.

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If the safety and efficacy profile of OV329 is positive, we will also consider lifecycle management strategies in broader epilepsy indications.

OV329 entered our pipeline in December 2016, when we entered into an exclusive, worldwide license agreement with Northwestern University.

The composition of matter patent for OV329 expires in 2036, excluding any potential regulatory extensions.

We have also filed, and own, multiple patent families directed to the synthesis of OV329 and methods of treatment with OV329.

Portfolio of KCC2 Transporter Activators, Including OV350

We in-licensed a large portfolio of compounds from AstraZeneca in December 2021 that are direct activators of a biological target expressed exclusively in the central nervous system:

the K-Cl co-transporter (KCC2).

OV329 Intravenous Formulation

We are actively formulating and conducting IND-enabling studies for an intravenous use of OV329, which would be intended for the treatment of acute seizures, such as refractory status epilepticus (“RSE”).

It is thought that approximately 35,000 Americans experience RSE.

RSE is defined as a medical emergency where patients experiencing seizures of five minutes of duration or longer do not respond to first or second-line therapies.

Status epilepticus (“SE”) and RSE can lead to enduring brain damage and increased rates of mortality.

While there is no intravenous formulation of vigabatrin for acute use, some investigator led studies have shown that the application of this GABA-AT inhibitor via a nasal-gastric tube has produced strong results that have led to the cessation of status epilepticus.

Drawing on these findings, Ovid intends to submit an IND (or an equivalent regulatory application) for the IV formulation of OV39 in late 2024 and advance it in human studies for potential use in refractory SE.

Portfolio of KCC2 Transporter Direct Activators, Including OV350

We in-licensed a large portfolio of compounds from AstraZeneca AB (“AstraZeneca”) in December 2021 that are direct activators of a biological target expressed exclusively in the CNS:

We believe this portfolio represents the only small molecule program in the biopharmaceutical industry that directly activates the KCC2 transporter.

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We intend to analyze multiple candidates from the KCC2 portfolio for development in epilepsy as well as other possible neurological conditions associated with behavior, neuropathic pain or neurodegeneration.

Since several compounds within the portfolio appear to be amenable for multiple formulations, the broad KCC2 program may provide Ovid with the ability to partner compounds for neurology indications outside our core competencies.

In vivo proof-of-concept studies in animals have established that restoring KCC2 activity leads to reduced seizure sensitivity and seizure-induced mortality.

In one preclinical model, designed to mimic the acute seizure state of status epilepticus (SE), OV350 terminated status and restored the efficacy of diazepam in SE seizures, whereas diazepam treatment alone failed to halt the seizures.

In one preclinical model, designed to mimic the acute seizure state of SE, OV350 terminated status and restored the efficacy of diazepam in SE seizures, whereas diazepam treatment alone failed to halt the seizures (see Figure 5 below).

Preclinical mechanistic studies have also demonstrated that OV350 was well-tolerated and did not induce sedation.

These findings must now be studied and demonstrated in humans.

In 2022, we evaluated several compounds in the KCC2 portfolio and began optimizing the lead candidate, OV350, for multiple possible formulations.

Our desire is to achieve both intravenous and oral administration formulations for OV350.

Dual formulations are optimal for patients who are treated acutely in the hospital and need to maintain seizure reduction in an out-patient setting.

As we advance the program, we will continue to conduct preclinical experiments to inform the development of other compounds from the portfolio, for epilepsies and other neurological conditions.

It is our expectation that the first IND from the program will be submitted in 2024.

OV350 Terminates Benzodiazepine Resistant Status Epilepticus

In 2023, we evaluated several compounds in the KCC2 portfolio and began optimizing the lead candidate, OV350, for possible intravenous and oral administration formulations.

Dual formulations are optimal for patients who are treated acutely in the hospital and need chronic dosing to maintain outcomes in an out-patient setting.

To support human studies, we initiated a range of disease model experiments in seizure and psychosis models.

As noted above, we believe that the anticonvulsant properties of OV350 are compelling in preclinical SE models.

Additionally, two different animal models that are a proxy for human psychosis suggest that OV350 has a profile akin to atypical antipsychotics, though, it does not appear to carry the undesirable tolerability issues common in medicines for mental health conditions.

Such a profile may represent an exciting profile for future psychosis medicines.

Further research and IND-enabling studies are ongoing.

We expect to submit the first IND from the KCC2 program by the end of 2024.

OV350 Demonstrates Antipsychotic Effects in Schizophrenia Model

The library of early-stage small molecules that target the KCC2 transporter, including OV350, are included in a pending composition-of-matter application that was filed globally and, if issued, will expire in 2041 excluding any potential regulatory extensions.

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However, we believe that genetic medicine will play an important role in the long-term future of treating genetic epilepsies and neurological disorders.

Accordingly, we engage in appropriately scaled, early-stage research programs with certain collaborators, including Gensaic, a next-generation gene therapy developer (see description in License & Collaboration section below).

OV815 and OV825

In 2022, we continued to progress candidates for antisense oligonucleotide (ASO) and RNAi medicines as part of our collaboration with Columbia University, including research programs OV815 and OV825.

OV815 focuses on the mutations associated with KIF1A-associated neurological disorder (KAND).

Research has harnessed phenotype mapping and identified potential sequences that target a significant number of mutations associated with KAND.

Similarly, OV825 has advanced to potential candidate lead identification for the rare neurodevelopmental condition HNRNPH2.

Also known as Bain Syndrome, HNRNPH2 is an X linked gene, and most affected individuals are females.

Patients with de novo mutations have delayed psychomotor development, intellectual disability, severe language impairment, seizures, behavioral abnormalities, acquired microcephaly, and feeding problems with poor overall growth.

We have sought a RNAi therapy approach to target the mutant form of the HNRNPH2 protein that mislocalizes to the cytoplasm in cells from affected

By year-end 2023, we anticipate reaching a critical mass of research to be able to make "go" or "no-go" decisions on these programs.

OV882 is a short hairpin RNA that we are evaluating as a potential disease-modifying gene therapy for Angelman syndrome.

The most common cause of Angelman syndrome is the loss of functional UBE3A protein due to a defect in the maternal copy of the UBE3A gene.

Our aim is to develop a disease-modifying vector that reduces expression of UBE3A-antisense and restores UBE3A expression via the paternal gene copy.

We are in early stages of our research with OV882, and we benefit from robust natural history and baseline data from a prior clinical trial that we conducted with gaboxadol in Angelman syndrome.

From this prior program, we have deep knowledge of the Angelman condition and retain ownership of baseline data from clinical trials with approximately 100 Angelman patients.

We expect that these proprietary insights will aid our OV882 program.

Accordingly, we engage in appropriately scaled, early-stage research programs with certain collaborators, including Gensaic, Inc., formerly M13 Therapeutics, Inc.

(“Gensaic”), a next-generation gene therapy developer.

Phage-Based Scaffolds:

Gensaic Research Collaboration

In August 2022, we entered into a research collaboration with Gensaic (Gensaic Collaboration Agreement), a private biotech company that is developing gene therapies.

In August 2022, we entered into an investment in and research collaboration with Gensaic (the “Gensaic Collaboration Agreement”), a private biotech company that is developing gene therapies.

Specifically, Gensaic is applying phage-display science that uses M13 phages as platforms to deliver genetic sequences.

Though still in its nascence, we believe phage-based scaffolds may offer significant advantages for the delivery of genes, as compared to the current platform alternatives of adeno-associated viral (“AAV”) vectors.

This collaboration is a part of a low cost and long-term strategy to potentially enable unique treatment modalities in genetic disorders with a potentially unique and proprietary, low-cost alternative to current therapies.

AAV gene therapies are not optimal for treating neurological conditions.

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avert the immune system response to enable redosing;

and be produced in more cost effective manner.

and be produced in a more cost-effective manner.

As a result, we believe phage-based gene therapy has an improved potential for the treatment of genetic epilepsies and neurological diseases.

We can pursue up to three genetic targets in collaboration with Gensaic.

We can pursue up to three targets in collaboration with Gensaic, which are not yet disclosed.

Genetic Programs:

OV815, OV825 and OV882

Prior to our strategic pipeline review in 2022, we had developed a series of early candidates for antisense oligonucleotide (“ASO”) and RNAi medicines as part of our collaborations with Columbia University and the University of Connecticut.

These research programs included:

OV815, which was in development for the treatment of mutations associated with KIF1A-associated neurological disorder (KAND);

HNRNPH2 (also known as Bain Syndrome), which was a potential treatment for an X linked gene predominantly occurring in females;

and OV882, a potential disease-modifying gene therapy for Angelman syndrome that used short hairpin RNA to deliver a vector that reduced expression of UBE3A-antisense and restores UBE3A expression.

At year-end 2023, we determined to pause these programs to prioritize our expanding clinical footprint in small molecule programs.

We will continue to seek collaborations or out-licensing opportunities for these programs.

License and Collaboration Agreements

2023 Ligand Pharmaceuticals Milestones and Royalties Monetization

In October 2023, we sold Ligand a 13% stake in the royalties and milestones owed to Ovid related to the potential approval and commercialization of soticlestat (the “Ligand Agreement”).

In return, we received a $30.0 million payment, less certain reimbursable expenses.

We retained 87% of our interest in soticlestat's potential royalties and milestones.

In the event that soticlestat is not approved and commercialized, we have no continuing debt or other obligations to Ligand.

2023 In-licensing and Collaboration Agreement with Graviton Bioscience Corporation

In April 2023, we entered into a Collaboration and License Agreement with Graviton, a privately held early-stage drug development company specializing in therapeutics that inhibit ROCK2.

Under the terms of the agreement, we purchased shares of Graviton's preferred stock for $10.0 million and secured rights to develop their lead program OV888 (GV101) as well as a portfolio of ROCK2 inhibitors in mutually agreed upon rare CNS indications, excluding amyotrophic lateral sclerosis.

The agreement provides us with worldwide rights, excluding China, Hong Kong, Macau and Taiwan.

Graviton is responsible for conducting the development of the products through the end of Phase 2 trials under the oversight of a joint development committee from both companies.

We are responsible for development and commercialization costs, post-Phase 2 development and commercialization of subsequent products.

The collaboration has no milestone payments and Graviton will be eligible for percentage royalties in the mid- to high-teens based on net sales in territories where the products are marketed.

Graviton retains rights to licensed products in all fields of study outside of rare brain disorders.

2022 Research Collaboration and Equity Investment in Gensaic

Under the terms of an equity agreement we entered into as an investor in Gensaic, we invested a total of $5.1 million in exchange for convertible preferred stock in Gensaic.

We also entered into the Gensaic Collaboration Agreement to potentially develop up to three genetic medicines for neurological indications of interest to us, harnessing Gensaic’s proprietary PDP platform.

We also entered into a collaboration agreement with Gensaic (the “Gensaic Collaboration Agreement”) to potentially develop up to three genetic medicines for neurological indications of interest to us, harnessing Gensaic’s proprietary phage-derived particle platform.

Gensaic retains full rights to its platform technology.

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2022 Out-License Agreement with Marinus Pharmaceuticals

On March 1, 2022, we entered into an exclusive patent license agreement with Marinus, ("Marinus License Agreement").

In March 2022, we entered into an exclusive patent license agreement with Marinus, (“Marinus License Agreement” ) .

Under the Marinus License Agreement, we granted Marinus an exclusive, non-transferable (except as expressly provided therein), royalty-bearing right and license under certain Ovid patents relating to ganaxolone to develop, make, have made, commercialize, promote, distribute, sell, offer for sale and import licensed products in the territory (which consists of the United States, the European Economic Area, United Kingdom and Switzerland) for the treatment of CDKL5 deficiency disorders.

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2022 License and Option Agreement with Healx

On February 1, 2022, we entered into an exclusive license option agreement ("Healx License and Option Agreement") with Healx, Ltd.

Under the terms of the Healx License and Option Agreement, Healx has secured a one-year option to investigate gaboxadol (OV101) as part of a potential combination therapy for Fragile X syndrome in a Phase 2A clinical trial, and as a treatment for other indications, for an upfront payment of $0.5 million, and fees to support prosecution and maintenance of our relevant intellectual property rights.

In February 2023, we amended the Healx License and Option Agreement to extend the option period by three months.

At the end of the option period, Healx has the option to

secure rights to an exclusive license under our relevant intellectual property rights, in exchange for an additional payment of $2.0 million, development and commercial milestone payments, and low to mid-tier double digit royalties.

In February 2022, we entered into an exclusive license option agreement (“Healx Agreement”) with Healx, Ltd (“Healx” ) .

Under the terms of the Healx Agreement, Healx has secured a one-year option to investigate gaboxadol (OV101) as part of a potential combination therapy for Fragile X syndrome in a Phase 2A clinical trial, and as a treatment for other indications, for an upfront payment of $0.5 million, and fees to support prosecution and maintenance of our relevant intellectual property rights.

In February 2023, we amended the Healx Agreement to extend the option period by three months.

At the end of the option period, Healx has the option to secure rights to an exclusive license under our relevant intellectual property rights, in exchange for an additional payment of $2.0 million (“Option Fee”), development and commercial milestone payments, and low to mid-tier double digit royalties.

Healx will assume all responsibility for, and costs of, both development and commercialization of gaboxadol following the exercise of the option.

We will retain the option to co-develop and co-commercialize the program with Healx, or the Ovid Opt-In Right, at the end of a positive readout of clinical phase 2B, in which case, and would share net profits and losses in lieu of the milestones and royalty payments.

In June 2023, the Healx Agreement was further amended to:

(i) grant Healx a development license;

(ii) grant a commercial license upon payment of the Option Fee to us;

and (iii) restructure the timing of the Option Fee payable to us.

Healx assumed all responsibility for and costs of development of gaboxadol in June 2023.

Healx will also be responsible for all commercialization costs of gaboxadol following the grant of a commercial license upon payment of the Option Fee.

We retain the option to co-develop and co-commercialize the program with Healx (“Ovid Opt-In Right”) at the end of a positive readout of clinical phase 2B, and, in such case, would share net profits and losses in lieu of the milestones and royalty payments.

We do not plan to conduct further trials of gaboxadol.

The term of the Healx License and Option Agreement will continue until the later of (a) the expiration of all relevant royalty terms, or in the event that Healx does not exercise its option during the option period defined in the Healx License and Option Agreement, or the Option Period, the expiration of such period, or in the event that Healx does exercise its option during the Option Period, and we do not exercise the Ovid Opt-In Right during the period of time we have to opt-in, or the Opt-In Period, or the opt-in terms are otherwise terminated, upon the expiration of all payment obligations, or (c) in the event that Healx does exercise the Option during the Option Period, and we do exercise the Ovid Opt-In Right during the Opt-In Period, such time as neither Healx nor Ovid is continuing to exploit gaboxadol.

As part of the contractual obligations with Lundbeck, we will owe Lundbeck a share of all milestone and royalty payments received from Healx, if we do not exercise the Ovid Opt-In Right.

If we exercise the Ovid Opt-In Right to co-develop and co-commercialize the program with Healx, we will owe a share of the net profit share to Lundbeck.

License Agreement with H.

In March 2015, we entered into a license agreement with Lundbeck, which we subsequently amended in May 2019, July 2020 and February 2022.

As part of the Lundbeck agreement, we obtained from Lundbeck an exclusive (subject to certain reserved non-commercial rights), worldwide license to develop, manufacture, and commercialize OV101, also known as gaboxadol, for the treatment of human disease.

We subsequently closed our OV101 (gaboxadol) program in Angelman syndrome in early 2021.

On February 1, 2022, we entered into Amendment No.

3 to the Lundbeck agreement, or Amendment No.

3, to permit our performance under the Healx License and Option Agreement.

Under the terms of Amendment No.

3, if Healx exercises its option, we will owe Lundbeck a share of all milestone and royalty payments received from Healx, if we choose not to exercise the Ovid Opt-In Right.

If we choose to exercise the Ovid Opt-In Right, co-develop and co-commercialize the program with Healx, we will owe a share of the net profit share to Lundbeck.

2021 Exclusive In-Licensing Agreement with AstraZeneca

On December 30, 2021, we entered into an exclusive license agreement, or the AstraZeneca Exclusive License Agreement, with AstraZeneca.

In December 2021, we entered into an exclusive license agreement (“AstraZeneca Exclusive License Agreement” ) with AstraZeneca.

Under the terms of the AstraZeneca Exclusive License Agreement, we have obtained worldwide rights to a portfolio of early-stage, small molecule compounds targeting the KCC2 transporter, including our lead compound, OV350.

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The license option will continue until the expiration of all relevant royalty terms.

Northwestern License

In December 2016, we entered into a license agreement with Northwestern, pursuant to which Northwestern granted us an exclusive, worldwide license to patent rights in certain inventions, or the Northwestern Patent Rights, which relate to a specific compound (OV329) and related methods of use for such compound, along with certain Know-How related to the practice of the inventions claimed in the Northwestern Patents.

Under the Northwestern agreement, we were granted exclusive rights to research, develop, manufacture and commercialize products utilizing the Northwestern Patent Rights for all uses.

We have agreed that we will not use the Northwestern Patent Rights to develop any products for the treatment of cancer, but Northwestern may not grant rights in the technology to others for use in cancer.

We also have an option, exercisable during the term of the agreement to an

exclusive license under certain intellectual property rights covering novel compounds with the same or similar MoA as the primary compound that is the subject of the license agreement.

Northwestern has retained the right, on behalf of itself and other non-profit institutions, to use the Northwestern Patent Rights and practice the inventions claimed therein for educational and research purposes and to publish information about the inventions covered by the Northwestern Patent Rights.

2016 Northwestern License for OV329

In December 2016, we entered into a license agreement (“Northwestern Agreement”) with Northwestern University (“Northwestern”), pursuant to which Northwestern granted us an exclusive, worldwide license to patent rights in certain inventions (“Northwestern Patent Rights”) which relate to a specific compound (OV329) and related methods of use for such compound, along with certain know-how related to the practice of the inventions claimed in the Northwestern Patent Rights.

Under the Northwestern agreement, we were granted exclusive rights to research, develop, manufacture and commercialize products utilizing the Northwestern Patent Rights for all uses, other than cancer.

Upon entry into the Northwestern Agreement, we paid an upfront non-creditable one-time license issuance fee of $75,000, and we are required to pay an annual license maintenance fee of $20,000, which will be creditable against any royalties payable to Northwestern following first commercial sale of licensed products under the agreement.

We are responsible for all ongoing costs of filing, prosecuting and maintaining the Northwestern Patents, but we also have the right to control such activities using our own patent counsel.

We are responsible for all ongoing costs of filing, prosecuting and maintaining the Northwestern Patent Rights, but we also have the right to control such activities using our own patent counsel.

In consideration for the rights granted to us under the Northwestern agreement, we are required to pay to Northwestern up to an aggregate of $5.3 million upon the achievement of certain development and regulatory milestones for the first product covered by the Northwestern Patents, and, upon commercialization of any such products, will be required to pay to Northwestern a tiered royalty on net sales of such products by the Company, its affiliates or sublicensees, at percentages in the low to mid-single-digits, subject to standard reductions and offsets.

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Northwestern may terminate the agreement for our uncured material breach or insolvency.

2015 License Agreement with H.

In March 2015, we entered into a license agreement with Lundbeck, which we subsequently amended in May 2019, and July 2020 (collectively, the “Lundbeck Agreement”).

As part of the Lundbeck Agreement, we obtained from Lundbeck an exclusive (subject to certain reserved non-commercial rights), worldwide license to develop, manufacture and commercialize OV101, also known as gaboxadol.

We subsequently closed our OV101 (gaboxadol) program in Angelman syndrome in early 2021.

In February 2022, we entered into Amendment No.

3 to the Lundbeck Agreement (the “Amended Lundbeck Agreement”) to permit our performance under the Healx Agreement.

Under the terms of the Amended Lundbeck Agreement, if Healx exercises its option, we will owe Lundbeck an equal share of all milestone and royalty payments received from Healx, if we choose not to exercise the Ovid Opt-In Right.

If we choose to exercise the Ovid Opt-In Right, to co-develop and co-commercialize the program with Healx, we will owe an equal share of the net profit share to Lundbeck.

Sales and Marketing

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We believe Zogenix, Inc.

(acquired by UCB in 2022), Jazz Pharmaceuticals plc, Sage Therapeutics, Inc., Marinus Pharmaceuticals, Inc., Mallinckrodt plc, SK Biopharmaceuticals Inc., Epygenix Therapeutics, Inc., Stoke Therapeutics, Inc., and Xenon Pharmaceuticals, Inc.

(acquired by UCB in 2022), Jazz Pharmaceuticals plc (acquired by UCB in 2022), Sage Therapeutics, Inc., Marinus Pharmaceuticals, Inc., Mallinckrodt plc, SK Biopharmaceuticals Inc., Epygenix Therapeutics, Inc., Stoke Therapeutics, Inc.

and Xenon Pharmaceuticals, Inc.

are our most direct competitors with respect to soticlestat, OV329 and OV350.

As it relates to OV888 (GV101), we believe Neurelis Inc.

is our most direct competitor.

Drug development is highly competitive and subject to rapid and significant technological advancements.

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We have also filed, and own, multiple patent families directed to methods of treatment and formulations with OV101.

OV329 was in-licensed from Northwestern University.

Subsequently, we have licensed much of this portfolio to Healx under the Amended Healx Agreement.

OV329 was in-licensed from Northwestern.

OV329's composition of matter patent expires in 2036, excluding regulatory extensions.

We have also filed, and own, multiple patent families directed to the synthesis of OV329 and methods of treatment with OV329.

OV888 (GV101) was licensed from Graviton.

The composition of matter patent for OV88 expires in October 2038 excluding any potential regulatory extensions.

Graviton has also filed patents on methods of use with OV888 (GV101).

A library of early-stage small molecules that target the KCC2 transporter, including OV350 was in-licensed from AstraZeneca.

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In addition, in certain instances, a patent term can be extended to recapture a portion of the U.S.

Patent and Trademark Office, or the USPTO, delay in issuing the patent as well as a portion of the term effectively lost as a result of the FDA regulatory review period.

Patent and Trademark Office (the “USPTO”) delay in issuing the patent as well as a portion of the term effectively lost as a result of the FDA regulatory review period.

However, as to the FDA component, the restoration period cannot be longer than five years and the total patent term including the restoration period must not exceed 14 years following FDA approval.

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Furthermore, we rely upon trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position.

We seek to protect our proprietary information, in part, using confidentiality agreements with our employees and consultants and any potential commercial partners and collaborators and invention assignment

agreements with our employees.

We also have or intend to implement confidentiality agreements or invention assignment agreements with our selected consultants and any potential commercial partners.

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Government Regulation

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act ( “ FDCA ” ) and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent compliance with applicable

federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

Failure to comply with the applicable U.S.

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The process required by the FDA before a drug product may be marketed in the United States generally involves the following:

• completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations.

• completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice ( “ GLP ” ) regulations;

• submission to the FDA of an IND which must become effective before human clinical trials may begin;

• approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated.

• performance of adequate and well controlled human clinical trials in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug product for each indication.

• approval by an independent institutional review board ( “ IRB ” ) at each clinical site before each trial may be initiated;

• performance of adequate and well controlled human clinical trials in accordance with good clinical practice ( “ GCP ” ) requirements to establish the safety and efficacy of the proposed drug product for each indication;

• submission to the FDA of an NDA or BLA;

• satisfactory completion of an FDA advisory committee review, if applicable;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice ( “ cGMP ” ), requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

• FDA review and approval of the NDA or BLA.

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In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution.

Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their www.clinicaltrials.gov website.

Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health ( “ NIH ” ) for public dissemination on their www.clinicaltrials.gov website.

Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:

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Marketing Approval

among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications.

Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications.

In most cases, the submission of an NDA or BLA is subject to a substantial application user fee.

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.

Under the Prescription Drug User Fee Act ( “ 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 twelve months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision.

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The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.

In addition, under the Pediatric Research Equity Act of 2003, or PREA, as amended and reauthorized, certain research must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

In addition, under the Pediatric Research Equity Act of 2003 ( “ PREA ” ) as amended and reauthorized, certain research must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.

The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks.

The FDA also may require submission of a risk evaluation and mitigation strategy ( “ REMS ” ) plan to ensure that the benefits of the drug outweigh its risks.

The REMS plan could include medication guides, physician communication plans, assessment plans, or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk minimization tools.

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Other Healthcare Laws

Because of our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors, we will also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which we will conduct our business, including our clinical research, proposed sales, marketing and educational programs.

Because of our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors, we will also be subject to healthcare regulation and enforcement by the federal government and the state and foreign governments in which we will conduct our business, including our clinical research, proposed sales, marketing and educational programs.

laws that may affect our ability to operate, among others, include:

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates,” including their covered subcontractors, that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to certain electronic healthcare transactions and protecting the security and privacy of protected health information;

the federal Health Insurance Portability and Accountability Act of 1996 ( “ HIPPA ” ), as amended by the Health Information Technology for Economic and Clinical Health Act ( “ HITECH ” ), which governs the conduct of “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates,” including their covered subcontractors, that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to certain electronic healthcare transactions and protecting the security and privacy of protected health information;

certain state laws governing the privacy and security of health information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

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federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to

Department of Health and Human Services information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.

the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S.

Department of Health and Human Services ( “ HHS ” ) information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.

In addition, many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

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The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could significantly reduce our revenues from the sale of our products.

For example, implementation of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively the Affordable Care Act, or the PPACA, has substantially changed healthcare financing and delivery by both governmental and private insurers, and significantly impacted the pharmaceutical industry.

For example, implementation of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively the Affordable Care Act ( “ PPACA ” ), has substantially changed healthcare financing and delivery by both governmental and private insurers, and significantly impacted the pharmaceutical industry.

The PPACA, among other things, established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs under the Medicaid Drug Rebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, provided incentives to programs that increase the federal government’s comparative effectiveness research and created a licensure frame work for follow-on biologic products.

Since its enactment there have been executive, judicial and Congressional challenges to certain aspects of the PPACA.

For example, President Trump has signed several Executive Orders and other directives designed to delay the implementation of certain provisions of the PPACA or otherwise circumvent some of the requirements for health insurance mandated by the PPACA.

Concurrently, Congress considered legislation to repeal or repeal and replace all or part of the PPACA.

While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the PPACA have been signed into law.

The Tax Cuts and Jobs Act of 2017, or the Tax Act, includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”.

On June 17, 2021, the U.S.

For example, on June 17, 2021, the U.S.

Supreme Court dismissed a challenge on procedural grounds that argued the PPACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.

Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025.

Further, on August 16, 2022, President Biden signed the

Inflation Reduction Act of 2022 ( “ IRA ” ) into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

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This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, including the BBA, will remain in effect until 2032 unless additional Congressional action is taken.

Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester.

Additionally, in January 2013, then President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period

for the government to recover overpayments to providers from three to five years.

Congress is also considering additional health reform measures.

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For example, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs.

In response to Biden’s executive order, on September 9, 2021, the U.S.

Department of Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

Further, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges.

Additionally, the Biden administration released an additional executive order on October 14, 2022, directing HHS to report on how the Center for Medicare and Medicaid Innovation can be further leveraged to test new models for lowering drug costs for Medicare and Medicaid beneficiaries.

We expect that additional federal and state, as well as foreign, healthcare reform measures will be adopted in the future, any of which could result in reduced demand for our products or additional pricing pressure.

These provisions started to take effect in fiscal year 2023 and will continue to take effect progressively thereafter, although may be subject to legal challenges.

On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges.

It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry.

In response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the CMS Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care.

It is unclear whether the models will be utilized in any health reform measures in the future.

Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

Human Capital Management

Our employees are dedicated to our mission of developing and delivering medicines that provide meaningful improvements to the lives of people and families affected by epilepsies and seizure-related disorders.

Our employees are dedicated to our mission of developing and delivering medicines that create new possibilities and more good days for people living with epilepsies and brain conditions.

As of December 31, 2023, we had 40 full-time employees, the majority of whom were primarily engaged in research and development activities, including five individuals with M.D.

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We emphasize a number of measures and objectives in managing our human capital assets, including, among others:

employee engagement, development and training, talent acquisition and retention, employee wellness, diversity, inclusion, and compensation and equity.

employee engagement, development and training, talent acquisition and retention, employee wellness, diversity, inclusion, and compensation, benefits and equity.

We believe that developing a diverse and inclusive culture is central to continuing to attract and retain the top talent necessary to deliver on our growth strategy.

As such, we are investing in a work environment in which our employees feel inspired, included and enjoy a strong sense of belonging.

This includes a focus on extending our diversity, equity, inclusion and belonging (DEIB) initiatives across our entire workforce, with specific employee engagement via the DEIB Committee.

Approximately 50% of the Company employees are female, as are one-third of our board of directors.

This includes a focus on extending our diversity,

equity, inclusion and belonging (“DEIB”) initiatives across our entire workforce, with specific employee engagement via the DEIB Committee.

Approximately half of our employees are female, as are one-third of our board of directors.

Approximately half of our organization is multicultural.

We value our employees’ insatiable curiosity to translate scientific discoveries into innovative medicines, their courage and perseverance to overcome obstacles and operate with a sense of purpose and urgency on behalf of patients.

We value our employees’ insatiable curiosity to translate scientific discoveries into innovative medicines and their courage and perseverance to overcome obstacles and operate with a sense of purpose and urgency on behalf of patients.

Grounded in these guiding principles, we believe we have developed a collaborative environment where our colleagues feel respected, valued, and can contribute to their fullest potential.

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Among our Board of Directors, five out of six members are independent.

Collectively, our Board provides insight and expertise in areas of import to the performance and growth of our enterprise, including experience as:

senior operators of public companie s;

Collectively, our Board of Directors provides insight and expertise in areas of importance to the performance and growth of our enterprise, including experience as:

senior operators of public companies;

financial, transactional and oversight experience at public companies;

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Information contained on or accessible through our website is not a part of this Annual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only.

We file electronically with the Securities and Exchange Commission, or the SEC, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

We file electronically with the Securities and Exchange Commission (“SEC”) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

We make available on our website at www.ovidrx.com under “Investors,” free of charge, copies of these reports as soon as reasonably practicable after filing or furnishing these reports with the SEC.

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What changed 10-K

Item 1. Business