−Removed: Ovid is a biopharmaceutical company that is dedicated to developing small molecule medicines for brain conditions with significant unmet need.
−Removed: These potential medicines targeting the central nervous system (“CNS”) are designed to potentially halt the course of brain disease by quelling neural hyper-excitation and alleviating the most impactful patient symptoms.
+Added: Ovid is a biopharmaceutical company that is dedicated to developing small molecule medicines for brain disorders with significant unmet need.
+Added: These potential medicines targeting the central nervous system (“CNS”) are designed to potentially halt the course of brain disease by quelling neuronal hyperexcitation and alleviating the most impactful patient symptoms.
We seek to address fundamental biological targets in the brain that are implicated in neuronal hyperexcitability, such as neurotransmitters and dysregulated ion channels.
−Removed: By mitigating excessive neuronal hyper-excitation with differentiated medicines, we believe we can unlock substantial scientific, therapeutic and commercial opportunities across a range of neurological and psychiatric conditions that have few therapeutic options today, both impacting patients’ lives and creating long-term stockholder value.
−Removed: Over the last decade, scientific understanding of the underlying biology of neuronal hyperexcitability and the related pathophysiology of epilepsies, psychoses, and other brain conditions has significantly advanced.
+Added: By mitigating excessive neuronal hyperexcitation with differentiated medicines, we believe we can unlock substantial scientific, therapeutic and commercial opportunities across a range of neurological and psychiatric conditions that have few therapeutic options today, both impacting patients’ lives and creating long-term stockholder value.
+Added: Over the last decade, scientific understanding of the underlying biology of neuronal hyperexcitability and the related pathophysiology of epilepsies, psychoses, and other brain disorders has significantly advanced.
Today, the underpinnings of many monogenic epilepsies and seizure disorders are becoming better understood and can be linked to mutations in specific molecular transporters, ion channels and receptors.
−Removed: Additionally, science is beginning to illuminate the systemic and damaging effects of over-excitation on neural networks, including its relationship to cell inflammation, stress, and apoptosis.
−Removed: This improved understanding of the genesis and pathophysiology of disease, coupled with advances in preclinical research tools, is enhancing the predictive potential of translational research, and is thereby improving the probability of successful clinical development of CNS medicines.
+Added: Additionally, science is beginning to illuminate the systemic and damaging effects of over-excitation on neuronal networks, including its relationship to cell inflammation, stress and apoptosis.
+Added: This improved understanding of the genesis and pathophysiology of disease, coupled with advances in preclinical research tools, is enhancing the predictive potential of translational research, and thereby improving the probability of successful clinical development of CNS medicines.
Additionally, emerging scientific evidence suggests that hyperexcitability of neurons is implicated in a broad range of conditions well beyond seizures and psychoses.
−Removed: Therefore, ameliorating excessive neural hyperexcitability may offer therapeutic relevance and applications in a broad array of brain disorders, including certain psychiatric, neurodegenerative and neurodevelopmental conditions, and other brain traumas.
+Added: Therefore, ameliorating excessive neuronal hyperexcitability may offer therapeutic relevance and applications in a broad array of brain disorders, including certain psychiatric, neurodegenerative and neurodevelopmental conditions, and other brain traumas.
Despite the scientific advances mentioned above, the unmet need for people living with seizures, epilepsies, and psychiatric diseases remains significant.
−Removed: Relatively few therapeutics targeting new mechanisms of action (“MoAs”) have been approved in recent decades, and most patients are not ‘cured’ of these conditions.
+Added: Relatively few therapeutics utilizing new mechanisms of action (“MoAs”) have been approved in recent decades, and most patients are not ‘cured’ of these conditions.
Therefore, the need and opportunity for medicines that act upon fundamental biological targets that impact neuronal excitatory/inhibitory balance remain substantial.
Our vision and focus
−Removed: Our vision is to create sustained, long-term value by advancing a differentiated pipeline of precision, small molecule medicines intended to culminate in a fully integrated neurotherapeutics company with multiple clinical-stage programs and commercial medicines.
+Added: Our vision is to create sustained long-term value by advancing a differentiated pipeline of small molecule medicines intended to culminate in a fully integrated neurotherapeutics company with multiple clinical-stage programs and commercial medicines.
We believe the lack of new classes of medicine in neurology and neuropsychiatry represents both an unmet need and a significant opportunity.
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It is our intent to eventually market a franchise of unique medicines that mitigate patient symptoms, such as seizures and psychoses, that stem from hyper-excited neurons.
−Removed: Over time, our efforts have resulted in four clinical-stage drug development programs, including two programs that have advanced to late-stage trials.
−Removed: Our current clinical programs are indicated for the potential treatment of drug-resistant epilepsies (“DRE”) and psychosis associated with neuronal-synuclein diseases (“NSD”), which includes Parkinson’s disease, and Lewy body dementia (“LBD”).
−Removed: Several preclinical programs are anticipated to be advanced for other forms of psychosis and mood disorders.
+Added: Over time, our efforts have resulted in five clinical-stage drug development programs, including two programs that advanced to late-stage trials.
+Added: Our current clinical programs are indicated for the potential treatment of drug-resistant focal onset seizures (“FOS”), developmental and epileptic encephalopathies (“DEEs”), including tuberous sclerosis complex (“TSC”) seizures and infantile spasms (“IS”) , psychosis associated with Parkinson’s disease and Lewy body dementia (“LBD”), and schizophrenia.
+Added: Several preclinical programs are also anticipated to be advanced for other forms of psychosis and mood disorders.
Importantly, we seek to develop medical therapies that are more efficacious and/or have ‘gentler’ profiles for patients, meaning drugs that are intended to deliver preferable safety and tolerability profiles relative to approved drugs.
Improved product profiles in neurology and psychiatry are needed, given that many patients require polypharmacy regimens that create cumulative tolerability issues and drug-drug interactions, significantly impacting quality of life and adherence to therapy.
−Removed: Our near-term strategy is focused on clinical advancement of potential small molecule medicines to treat specific epilepsies and psychoses that are manifestations of neural excitatory/inhibitory imbalance.
−Removed: This cohesive scientific focus,
−Removed: reinforced by our deep professional experience and pipeline of differentiated assets, gives us confidence that we can succeed in our mission.
−Removed: Additionally, we seek to create stockholder value by creating multiple sources of potential revenue via clinical and commercial milestones from our pipeline, strategic collaborations and partnerships.
+Added: Our near-term strategy is focused on clinical advancement of potential small molecule medicines to treat specific epilepsies and psychoses that are manifestations of neuronal excitatory/inhibitory imbalance.
+Added: This cohesive scientific focus, reinforced by our deep professional experience and pipeline of differentiated assets, gives us confidence that we can succeed in our mission.
+Added: Additionally, we seek to create stockholder value by establishing multiple sources of potential revenue via clinical and commercial milestones from our pipeline, strategic collaborations and partnerships.
Unmet need and opportunity
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For example, the U.S.
−Removed: Food and Drug Administration (“FDA”) has encouraged developers to seek “basket labels” for single therapeutic agents that cover more than one underlying disease, such as developmental epileptic encephalopathies (“DEEs”).
+Added: Food and Drug Administration (“FDA”) has encouraged developers to seek “basket labels” for single therapeutic agents that cover more than one underlying disease, such as DEE.
For the first time in 50 years, a therapeutic with a novel MoA was approved in schizophrenia in 2024.
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While modern drug discovery efforts have produced more than 30 anti-seizure medications (“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.
−Removed: Individuals who suffer from rare forms of epilepsies may experience persistent refractory seizures, with rates ranging from 50% to 90%.
+Added: Individuals who suffer from rare epilepsies may experience persistent refractory, or drug-resistant, seizures with rates ranging from 50% to 90%.
The seizures they suffer can have a devastating impact both upon patients and their families, by triggering permanent motor, cognitive and developmental delays.
−Removed: Some patients with DEEs experience even greater rates of refractory seizures that are resistant to drug therapy.
+Added: Some patients with DEEs experience even greater rates of refractory seizures.
With an estimated 70% of epilepsy diagnoses occurring in people younger than 20 years of age, the need to treat seizures early and effectively is critical to mitigate worsening and permanent later-life disabilities.
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.
−Removed: 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.
+Added: The large population of patients requiring multiple drug therapies to control seizures, as well as persistent rates of breakthrough seizures, signal the urgent need for effective new medicines.
For these patients, MoAs that demonstrate improved efficacy, safety and tolerability profiles are optimal, as they may be more easily incorporated into existing treatment regimens.
Unmet need in psychosis and mood disorders
−Removed: While Ovid’s potassium chloride cotransporter 2 (“KCC2”) portfolio has potential applications across a range of psychoses and mood disorders, our focus for our first two programs is psychosis among people with NSD and LBD.
+Added: Current standards of care in psychosis rely largely on modulation of dopaminergic and serotonergic pathways.
+Added: While these approaches provide benefit for some patients, they often fail to adequately control symptoms and carry tolerability burdens.
+Added: We believe potassium-chloride cotransporter 2 (“KCC2”) modulation represents a differentiated, upstream mechanism designed to restore physiologic inhibitory tone and reestablish network stability, with the potential to improve both efficacy and safety outcomes.
+Added: While Ovid’s KCC2 direct activator portfolio has potential applications across a range of psychoses and mood disorders, the focus for our first oral program is psychosis associated with Parkinson’s disease and LBD.
These populations share a common pathological link, which is intraneuronal accumulation of alpha-synuclein, which leads to neurodegeneration.
−Removed: Today, there are more than 4.3 million people globally living with psychosis associated with NSD and LBD.
−Removed: In the United States LBD is the second most common dementia (psychoses affect 80% of the LBD population), affecting 1.5 million Americans (80% of the diagnosed dementia patients), and NSD impacts another one million Americans.
−Removed: These progressive clinical syndromes are characterized clinically by movement disorders, cognitive impairment, sleep dysregulation, and autonomic instability.
−Removed: Changes in perception are common, manifesting in visual illusions, misperceptions of visual stimuli and hallucinations, which can create health risks to patients and caregivers.
+Added: Today, there are more than 4.3 million people globally living with psychosis associated with Parkinson’s disease and LBD.
+Added: In the United States LBD is the second most common dementia (psychoses affect 80% of the LBD population), affecting 1.5 million Americans, and psychosis associated with Parkinson’s disease impacts approximately another one
+Added: million Americans.
+Added: These progressive syndromes are characterized clinically by movement disorders, cognitive impairment, sleep dysregulation and autonomic instability.
+Added: Changes in perception are common, manifesting in visual illusions, misperceptions of visual stimuli, and hallucinations, which can impact health and quality of life.
These conditions lead to high morbidity, mortality and healthcare costs.
Psychosis in these populations is also a high risk factor for hospitalization and nursing home placement.
−Removed: Atypical antipsychotics are contraindicated for NSD and
−Removed: LBD as they worsen motor features, their anti-dopaminergic pharmacology is untenable in Parkinson’s disease, and many carry a black box warning for mortality.
+Added: Atypical antipsychotics are contraindicated for psychosis associated with Parkinson’s disease and LBD as they may worsen motor features, their anti-dopaminergic pharmacology is untenable in Parkinson’s disease, and many carry a black box warning for mortality.
The current standard of care for psychosis related to Parkinson’s disease is Nuplazid® (pimavanserin), to which only a small proportion of patients fully respond.
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We believe that major developments in the understanding of the biology of these diseases now make it possible to address key areas of unmet need, including many neurological and psychiatric disorders, offering significant therapeutic potential.
−Removed: We are specifically cultivating a pipeline of potential first-in-class or potential best-in-class MoAs to treat the underlying causes of neuronal imbalance which can lead to manifestations such as seizures, psychosis, pain and other mood disorders.
+Added: We are specifically cultivating a pipeline of potential first-in-class or potential best-in-class MoAs to treat the underlying causes of neuronal imbalance which can lead to manifestations such as seizures, psychosis, schizophrenia, and mood disorders.
Collectively, our differentiated pipeline has produced multiple potential value-creating drug programs.
−Removed: Several of these therapeutic development programs — OV329, OV350 and OV888 (GV101) — aim to affect signaling and enzymatic pathways and vascular structures that modulate hyperexcitability of neurons.
+Added: Several of these therapeutic development programs — OV329, OV4071 and other KCC2 activators — aim to affect signaling and enzymatic pathways that modulate hyperexcitability of neurons.
Through our scientific expertise and strategic business development, we have performed translational research and in-licensed compounds to build a robust development pipeline of potential medicines, including:
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OV329 is intended to deliver preferable seizure reduction, safety profile and dosing relative to prior medicines in the class, which have known safety challenges.
−Removed: OV329 is an oral therapy intended to optimally regulate GAB
−Removed: • A, the inhibitory neurotransmitter.
−Removed: OV329 is nearing completion of a Phase 1 study that is evaluating safety, tolerability, and pharmacokinetics (“PK”), as well as evaluating biomarkers that offer insight into target engagement, pharmacodynamic (“PD”), and clinical effects.
−Removed: To date safety data of OV329 in healthy subjects has been well-tolerated with no serious adverse events reported.
−Removed: Initial biomarker data from the most recent multiple-ascending dose cohort suggest encouraging directional signs of target engagement and clinical effects as measured by MRS and TMS.
−Removed: These indicate signs of increased GABAergic activity consistent with the intended mechanism of action by inhibiting GABA-aminotransferase.
−Removed: • KCC2 library is a portfolio of potential first-in-class direct activators of potassium chloride cotransporter2.
+Added: OV329 is an oral therapy intended to optimally regulate GABA, the inhibitory neurotransmitter.
+Added: We announced the results of the OV329 Phase 1 study which evaluated safety, tolerability, and pharmacokinetics (“PK”), as well as biomarkers that offer insight into target engagement, pharmacodynamic (“PD”), and clinical effects.
+Added: OV329 demonstrated a favorable safety profile in healthy subjects and was well-tolerated with no serious adverse events (“SAEs”) reported.
+Added: Biomarker data suggest encouraging directional signs of target engagement and clinical effects as measured by magnetic resonance spectrometry (“MRS”) and transcranial magnetic stimulation (“TMS”).
+Added: These indicate signs of increased GABAergic activity consistent with the intended mechanism of action by inhibiting GABA-AT.
+Added: ◦ New data from an additional OV329 Phase 1 cohort shows continued differentiated safety and tolerability profile:
+Added: ▪ 7 mg SAD and MAD cohort (n=11) shows all adverse events reported as unrelated, mild and transient, no SAEs and continued clean ocular safety profile, with a predictable PK effect
+Added: ▪ Regulatory discussions underway in support of planned Phase 2 patient studies
+Added: ◦ Launching additive studies to expand OV329 into TSC and IS, areas where GABA-AT inhibition has been shown as a validated mechanism and OV329 potentially offers a differentiated safety profile in comparison to current standard of care, enabling earlier and longer use
+Added: • In TSC, POC safety and signal-finding study to initiate as early as Q4 2026
+Added: • In IS, infant formulation and enabling studies are ongoing
+Added: • Studies are going to be run in parallel to FOS program
+Added: • KCC2 library, a portfolio of potential first-in-class direct activators of potassium-chloride cotransporter 2.
KCC2 is a fundamental biological target, solely expressed in the CNS, that enables synaptic inhibition.
KCC2 dysregulation has been implicated in a broad range of neuropathologies.
−Removed: We are actively advancing up to four unique drug development programs that emerged from our KCC2 direct activator library containing more than 100 molecules.
−Removed: These include OV350 (intravenous injection), OV4071 (oral and intramuscular injection), OV4041 (oral) and another undisclosed molecule.
+Added: We are actively advancing multiple unique drug development programs that emerged from our KCC2 direct activator library containing more than 100 molecules.
+Added: We were the first to report data in humans from a KCC2 direct activator from our intravenous (IV) program, OV350, a first-in-human KCC2 direct activator.
+Added: Results of the Phase 1 first-in-human study of OV350 showed no treatment-related laboratory findings, no safety findings, and no treatment-related SAEs.
+Added: as predicted, and will inform dosing strategies for future KCC2 development programs.
+Added: These data support development of the Company’s oral direct activator programs, which are the focus of future development efforts.
+Added: The KCC2 direct activator pipeline includes OV4071 and other undisclosed molecules.
Each program has potential distinct therapeutic and potency characteristics as demonstrated in varying phenotypic screens and animal disease models, reflecting multiple therapeutic opportunities and optionality for co-development.
−Removed: The portfolio is being evaluated for a range of therapeutic indications, that have symptoms associated with psychoses or mood disorders.
−Removed: ◦ OV350, a first-in-human KCC2 direct activator.
−Removed: OV350 is the most advanced program in the KCC2 library and is expected to be the first direct activator dosed in humans.
−Removed: We filed for regulatory approval and initiated a Phase 1 study of OV350 among healthy volunteers in Australia.
−Removed: We intend to study the safety, tolerability and PK of this potential first-in-class program, which will deliver important insights to the oral KCC2 program.
−Removed: Both OV350 and OV4071 are intended for the potential treatment of psychosis associated with NSD and LBD.
−Removed: • OV888 (GV101), a highly selective inhibitor of rho-associated coiled-coil containing protein kinase 2 (“ROCK2”).
−Removed: OV888 (GV101) is a potential first-in-class medicine to treat cerebral cavernous malformations (“CCM”), a condition in which seizures are a common symptom.
−Removed: OV888 (GV101) has completed two Phase 1 double-blind, multiple-ascending dose trials with no serious adverse events reported.
−Removed: OV888 (GV101) was tested at doses of 100 mg, 200 mg and 600 mg and was well-tolerated at all doses.
−Removed: Headaches were the most common adverse event, reported in 23% of participants, which resolved in all patients.
−Removed: Signs of target engagement and a PD response were detected using biomarkers of IL-17 and IL-21 at the intended clinical dose.
−Removed: OV888 (GV101) is ready to be dosed in a Phase 2 study in patients with CCM, but we have paused initiation to evaluate emerging data from competitor and academic studies in CCM.
−Removed: Collectively, these development programs are expected to generate a range of value-creating milestones for investors in the near- and mid-term.
+Added: The portfolio is being evaluated for a range of therapeutic indications that have symptoms associated with psychoses and mood disorders.
+Added: • OV4071, a first-in-human oral KCC2 direct activator approved for clinical trial initiation.
+Added: OV4071 is the most advanced program in the KCC2 library.
+Added: We intend to initiate a Phase 1 clinical study in the second quarter of 2026 following receipt of Human Research Ethics Committee (HREC) approval and acknowledgement of our Clinical Trial Notification (CTN) from the Therapeutic Goods Administration (TGA ).
+Added: The Phase 1 clinical trial will study multiple dose levels in an ascending single and multiple dose trial.
+Added: ◦ As part of the OV4071 clinical development plan, Ovid intends to conduct a ketamine challenge study in mid-2026 to further characterize potential PD effects and establish proof-of-mechanism.
+Added: • Collectively, these development programs and other KCC2 direct activators in preclinical studies are expected to generate a range of value-creating milestones for investors in the near- and mid-term.
R&D strategy:
−Removed: Differentiated MoAs to precisely target the causes of neural hyperexcitability
+Added: Differentiated MoAs to precisely target the causes of neuronal hyperexcitability
Our R&D strategy is dedicated to designing medicines that can ameliorate excessive neuronal excitation and return neurons to a state of homeostasis, or electrophysiological “balance.” Many factors can contribute to neuronal hyperexcitability, including those that are intrinsic or extrinsic to the cell.
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Other factors are intrinsic to the neuron (e.g., genetic conditions or the disruption of neuronal metabolism).
−Removed: Whatever its origin, electrophysiological imbalance and resultant neuronal hyperexcitability manifests in a range of debilitating symptoms, including seizures and psychiatric symptoms such as psychosis, pain, behavioral, mood disorders and more.
−Removed: Such symptoms are prevalent and debilitating across a range of diagnoses, including:
+Added: Whatever its origin, electrophysiological imbalance and resultant neuronal hyperexcitability manifests in a range of debilitating symptoms, including seizures and psychiatric symptoms such as psychosis, behavioral, mood disorders and more.
+Added: Such symptoms are prevalent across a range of diagnoses, including:
epilepsies, neurodegenerative diseases and neurodevelopmental disorders.
−Removed: Therefore, drugging targets that lead to excessive neural excitation may have widespread therapeutic utility.
+Added: Therefore, drugging targets that lead to excessive neuronal excitation may have widespread therapeutic utility.
While some drug development companies focus exclusively on a single biological target or MoA, we believe that multiple MoAs will be necessary to effectively treat the heterogeneous causes of hyperexcitability.
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• Target validation and indication selection.
−Removed: Our therapeutic development programs focus on precise MoAs for biological targets that are confirmed to be relevant in excessive neural excitation with established relevance to hyperexcitability through in vitro and in vivo animal models.
+Added: Our therapeutic development programs focus on precise MoAs for biological targets that are confirmed to be relevant in excessive neuronal excitation with established relevance to hyperexcitability through in vitro and in vivo animal models.
Prior to advancing our drug candidates from nonclinical evaluation into clinical trials, we apply a systematic approach to de-risk molecules using emerging tools, phenotypic screens and animal disease biology models.
−Removed: Additionally, we prioritize targets that are either uniquely (1) expressed in the CNS, such as KCC2 co-transporters, or are (2) over-expressed in a pathological state, such as GABA-AT and ROCK2.
+Added: Additionally, we prioritize targets that are either uniquely (1) expressed in the CNS, such as KCC2 cotransporters, or are (2) over-expressed in a pathological state, such as GABA-AT.
• Prioritization of the total drug profile.
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Business development strategy:
−Removed: Pipeline built through disciplined business development and enhanced through academic collaborations
+Added: Pipeline built through disciplined business development and enhanced with academic collaborations
Ovid has primarily built our pipeline through strategic business development.
−Removed: We identify molecules with untapped potential value and seek to in-license or enter into collaborative agreements to secure such assets and advance clinical development.
−Removed: This strategy directs our efforts where we excel in creating value, shaping translational and clinical stage development.
−Removed: 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.
+Added: We identify molecules with untapped potential value and seek to in-license or enter into collaborative agreements to secure such assets and advance
+Added: clinical development.
+Added: This strategy directs our efforts where we excel in creating value and shaping translational and clinical stage development.
+Added: An integral part of our process is establishing collaborations with academic research centers to support translational expertise for our programs.
The multiple programs in our diversified pipeline provide optionality to pursue out-bound business development to expand our opportunities.
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Collectively, our senior management has transacted hundreds of in-licensing deals and collaborations.
−Removed: We continue to enhance and expand our pipeline via two complementary efforts:
+Added: We continue to enhance and expand our pipeline via two complementary strategies:
(1) internal R&D efforts in collaboration with external leaders in the field and academic collaborators;
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We take a scientifically driven and evidence-based approach to translation and clinical development of our programs.
−Removed: We are building our portfolio based on the existence of known biological rationales that are associated with
−Removed: targets, and which can be evaluated using validated biomarkers and clear endpoints that are meaningful to patients, clinicians and regulators.
+Added: 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 clear endpoints that are meaningful to patients, clinicians and regulators.
Our early clinical development efforts focus on time- and cost-efficient trials that address key questions critical to de-risking future development.
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Additionally, many are social media users, through which they learn new insights about their conditions and share relevant information and experiences.
−Removed: We conduct patient disease community outreach and activities to inform our clinical design, educate patients about trial opportunities and support efficient study enrollment.
+Added: We conduct patient community outreach and activities to inform our clinical design, educate patients about trial opportunities and support efficient study enrollment.
Fit-for-purpose infrastructure
−Removed: We have built a highly specialized, efficient, and focused infrastructure that supports our chosen area of neurotherapeutics development.
+Added: We have built a highly specialized, efficient, and focused infrastructure that supports our chosen areas of neurotherapeutics development.
This infrastructure spans the critical domains of R&D and market access strategy.
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This includes physicians, academic scientists, and commercial and biopharmaceutical industry leaders.
−Removed: We have two individuals with M.D.
−Removed: degrees and seven professionals with Ph.D.
−Removed: degrees specializing in the sciences.
+Added: We have three individuals with MD degrees and eight professionals with PhD degrees specializing in the sciences.
Our operational leaders have extensive experience developing, formulating, manufacturing, regulatory controls and implementing market access strategies for leading neurological medicines.
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Over time, we have built upon our core strength in the clinical development of medicines for anti-seizure and genetic neurodevelopmental conditions and expanded into adjacent therapeutic areas of drug development in the CNS where strong mechanistic evidence exists.
−Removed: Financial strategy
−Removed: We are focused on delivering long-term value for stockholders.
−Removed: Our financial strategy applies our capital in a focused manner to advance a differentiated pipeline of neurotherapeutics, which we believe will generate multiple value-creating data-driven milestones and ultimately commercial sales.
−Removed: Management believes that we currently have sufficient cash on hand to fund our operations into the second half of 2026.
−Removed: See “ Item 7.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources ” for more information.
Ovid pipeline
Our efforts have already brought drug candidates from POC into late-stage patient clinical trials.
−Removed: Today, we are one of the few companies that has researched and developed three distinct MoAs to target seizures and we believe we are the only company that has a portfolio of direct activators of KCC2.
−Removed: We believe this pipeline of potential first-in-class or best-in-class mechanisms differentiates us and provides the foundation for a productive franchise of potential small molecule neurotherapeutics for epilepsies, psychoses and other mood disorders.
−Removed: The following table (Figure 1) sets forth our drug candidate programs and their development status, their respective MoAs, and anticipated near-term milestones.
−Removed: In the event we are unable to raise capital or enter into partnerships or co-development opportunities as and when needed, we will be required to delay, reduce the scope of or eliminate research and development programs.
+Added: Today, we are one of the few companies that has researched and developed three distinct MoAs to target seizures and we believe we are the only company that holds a portfolio of direct activators of KCC2.
+Added: We believe this pipeline of potential first-in-class or best-in-class mechanisms differentiates us and provides the foundation for a productive franchise of small molecule neurotherapeutics for epilepsies, psychoses, schizophrenia and mood disorders.
+Added: The following table (Figure 1) sets forth our drug candidate programs and their development status, respective MoAs, and anticipated near-term milestones.
Ovid Therapeutics Pipeline
−Removed: Ovid has a Phase 2-ready ROCK2 inhibitor, OV888 (GV101), in collaboration with Graviton Bioscience.
−Removed: This program was cleared by regulators toinitiate Phase 2 but is currently paused while Ovid monitors the outcome of regulatory interactions by competitors.
OV329 - A next-generation GABA-AT inhibitor
−Removed: OV329 is a clinical-stage, next-generation GABA-AT inhibitor that we are developing for the treatment of adult and pediatric drug-resistant epilepsies.
+Added: OV329 is a clinical-stage, next-generation GABA-AT inhibitor that we are developing for the treatment of adult and pediatric DREs.
OV329 represents a potential best-in-class GABA-AT inhibitor and was designed to supplant vigabatrin (“VGB”), which is an approved therapeutic globally for the treatment of infantile spasms.
−Removed: VGB was a first-generation medicine that demonstrated substantial seizure reduction, however, its clinical and commercial use was limited by lack of a therapeutic window.
+Added: VGB was a first-generation medicine that demonstrated substantial seizure reduction;
+Added: however, its clinical and commercial use was limited by lack of a therapeutic window.
Specifically, VGB was proven to generate deleterious and irreversible ocular effects in some patients, including retinal degradation and irreversible vision loss that led to significant post-market restrictions and monitoring.
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In preclinical research it was demonstrated to be 100-fold more potent than VGB.
−Removed: We are actively studying an oral pill of OV329 in a Phase 1 trial that has multiple biomarkers to measure clinical effect and target engagement, in addition to evaluating safety, tolerability and PK.
−Removed: We believe that OV329 has the potential to be a therapeutic option for adult and pediatric drug-resistant epilepsies, including several DEEs.
+Added: An oral formulation of OV329 was assessed in a Phase 1 study with multiple biomarkers to measure clinical effect and target engagement, in addition to evaluating safety, tolerability and PK.
+Added: Following the successful completion of the initial cohorts, we are conducting additional higher dose cohorts of OV329 evaluating safety, tolerability and PK.
+Added: We believe that OV329 has the potential to be a therapeutic option for adult DREs, including FOS, and DEEs, including TSC and IS.
+Added: The data from the Phase 1 study support advancing OV329 into a Phase 2 trial.
A benefit of our OV329 program is that it acts upon a validated drug target for seizures.
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OV329 profile
−Removed: Based upon preclinical data supporting OV329, we believe it has the potential to provide (in comparison to VGB) greater seizure reduction efficacy and improved tolerability and safety profiles without sedation, and lower dosing in comparison to existing therapeutics.
+Added: Based upon preclinical data supporting OV329, we believe it has the potential to provide (in comparison to VGB) greater seizure reduction efficacy, improved tolerability and safety profiles without sedation, and lower dosing in comparison to existing therapeutics.
To support OV329’s anti-convulsant profile, nine animal seizure models have demonstrated its seizure reducing effects (see Figure 2 below).
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OV329 safety profile
−Removed: To date, OV329 has exhibited acceptable tolerability in humans in our Phase 1 study.
−Removed: There have been no drug-associated serious adverse events reported and minor and transient adverse events, such as headache.
+Added: To date, OV329 has been well tolerated in humans in our Phase 1 study.
+Added: There have been no treatment-related serious adverse events reported, and only mild and transient treatment-related adverse events reported, such as headache.
Additionally, to characterize OV329’s potential safety profile relative to VGB, our preclinical efforts sought to extensively study safety and tolerability, including any potential ocular changes.
−Removed: We are cleared to study OV329 in humans with daily dosing for 28 days.
−Removed: Toxicology that enables our Phase 2 program is expected to be completed by third quarter 2025.
We have demonstrated that the tissue clearance of OV329 is rapid, which when coupled with its potency and irreversible binding, leads us to believe that the accumulation in the back of the eye does not occur as it does with VGB, which has a longer half-life.
−Removed: In 2024, we presented results at the American Epilepsy Society meeting of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with VGB.
+Added: We presented results at the American Epilepsy Society meeting of a head-to-head animal study evaluating whether OV329 could be found to accumulate in mouse retinas and brains, as has been previously shown to occur with VGB.
The preferential accumulation of VGB in the eye is thought to be a contributing factor in VGB’s ocular toxicity.
−Removed: The findings (summarized in Figure 3 below), found that OV329 cleared and remained undetectable in the retinas, eyes, and brains of mice after 48 hours of continuous exposure via a sub-cutaneous osmotic pump, suggesting a lack of accumulation.
+Added: The findings (summarized in Figure 3 below), were that OV329 cleared and remained undetectable in the retinas, eyes, and brains of mice after 48 hours of continuous exposure via a sub-cutaneous osmotic pump, suggesting a lack of accumulation.
In contrast, ocular accumulation of VGB was confirmed within this period.
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Human studies and biomarker strategy
−Removed: Our Phase 1 trial of OV329 is currently ongoing with CMAX Clinical Research in Adelaide, Australia, with topline data expected in the third quarter of 2025.
−Removed: The trial is being conducted in two parts, including:
−Removed: a single-ascending dose and a multiple-ascending dose portion.
−Removed: Endpoints will evaluate the PK profile, safety, tolerability and target engagement associated with escalating doses of OV329 in healthy volunteers.
−Removed: Two surrogate biomarkers are being applied in the study, including:
−Removed: (1) transcranial magnetic stimulation (“TMS”), which is being measured as a corollary for clinical biological effect and (2) magnetic resonance spectrometry (“MRS”), which will be used to measure target engagement.
−Removed: Initial biomarker data from the most recently completed multiple-ascending dose cohort suggests encouraging directional signs of target engagement and clinical effects as measured by the above stated biomarkers.
+Added: We announced topline results of our Phase 1 trial of OV329 in the third quarter of 2025 and presented these data at the 2025 American Epilepsy Society Meeting.
+Added: The Phase 1 trial evaluated PK profile, safety, tolerability and target engagement associated with escalating doses of OV329 in healthy volunteers.
+Added: Two surrogate biomarkers, TMS and MRS, were included as exploratory biomarkers in the study to measure a corollary for clinical biological effect and target engagement.
+Added: Biomarker data suggest encouraging directional signs of target engagement and clinical effects as measured by the utilized biomarkers.
These findings indicate signs of increased GABAergic activity consistent with the intended mechanism of action by inhibiting GABA-aminotransferase.
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These metrics coupled with safety, data and pharmacokinetic data may inform mid- to late-stage development of the program.
−Removed: Upon results from the Phase 1 program, we anticipate OV329 could be further studied for the potential treatment of drug-resistant epilepsies, including adult epilepsies and DEEs.
−Removed: OV350 and KCC2 direct activator portfolio
−Removed: In late 2021, we in-licensed a portfolio of more than 100 molecules from AstraZeneca AB (“AstraZeneca”), which are direct activators of the KCC2.
+Added: OV329 will be further studied for the potential treatment of DREs, including FOS.
+Added: We announced that we will be pursuing additional POC studies in TSC and IS, which will be run in parallel to our program in FOS.
+Added: OV329 has the potential to have differentiated safety profile as compared to current standard of care;
+Added: enabling earlier and longer use.
+Added: Our confidence in these programs comes from validated novel MOA, which offers the transformative potential to alter the course of disease.
+Added: These additional indications open a large opportunity for OV329, as it has a differentiated safety and tolerability profile, along with robust target engagement and potential flexibility of use with no anticipated titration and no drug-drug interactions.
+Added: Preclinical data support OV329’s potential efficacy with compelling anti-convulsant effects in a mouse model of infantile spasm, and in animal models of focal seizures.
+Added: Importantly, we have a robust body of clinical and preclinical data demonstrating that OV329 does not accumulate in the retina, greatly improving upon the ophthalmic risk associated with VGB.
+Added: OV329 Development Timelines
+Added: With the addition of TSC and IS, we have expanded an additional path to registration, and have also supplemented a catalyst-rich pipeline that potentially unlocks the full value of OV329.
+Added: KCC2 direct activator portfolio
+Added: In late 2021, we in-licensed a portfolio of more than 100 molecules from AstraZeneca AB (“AstraZeneca”), which are direct activators of KCC2.
Since that time, we have extensively characterized the library for bioavailability, formulation amenability and therapeutic potential.
−Removed: As a result, we now have four unique programs that we intend to successively progress into human clinical studies.
−Removed: These include OV350, OV4071 and OV4041 and another undisclosed program.
−Removed: Based upon our phenotype screens, disease model studies, and published evidence, we believe this portfolio offers broad therapeutic potential in a range of potential brain conditions and symptoms including psychosis, other behavior and mood disorders, and seizures.
+Added: As a result, we now have three unique programs that we intend to successively progress into human clinical studies.
+Added: These include OV4071 and other undisclosed programs.
+Added: Based upon our phenotype screens, disease model studies, and published evidence, we believe this portfolio offers broad therapeutic potential in a range of brain disorders and symptoms including psychosis, schizophrenia, other behavior and mood disorders, and seizures.
This may include neurodegenerative and neurodevelopmental diseases that exhibit the above mentioned symptoms.
−Removed: Given the broad therapeutic relevance of KCC2 in many brain disorders, it is our desire to unlock the full value of KCC2 for shareholders and patients.
−Removed: We will explore doing so through our own development efforts and via potential development partners.
+Added: Given the broad therapeutic relevance of KCC2 in many brain disorders, it is our desire to unlock the full value of KCC2 for stockholders and patients.
A fundamental target in the CNS
KCC2 is a fundamental biological target expressed exclusively in the CNS and is central to maintaining synaptic inhibition.
−Removed: Hundreds of publications link KCC2 dysregulation directly or indirectly to various medical conditions and symptoms associated with excessive neural excitation.
−Removed: KCC2 is an ion co-transporter that regulates chloride extrusion in neurons.
−Removed: A functioning chloride gradient is essential to GABA being inhibitory in neural synapses.
+Added: Hundreds of publications link KCC2 dysregulation directly or indirectly to various medical conditions and symptoms associated with excessive neuronal excitation.
+Added: KCC2 is an ion cotransporter that regulates chloride extrusion in neurons.
+Added: A functioning chloride gradient is essential to GABA being inhibitory in neuronal synapses.
By directly activating KCC2, our development programs seek to restore GABAergic inhibition and bring hyper-excited neurons into homeostasis.
−Removed: We believe that our KCC2 portfolio represents the only small molecule library within the broad biopharmaceutical industry that directly activates this unique ion co-transporter.
−Removed: Other companies have tried to activate KCC2.
−Removed: To our knowledge none, apart from us, have been successful, though some companies may potentiate the co-transporter, which will likely have different clinical effects.
+Added: We believe that our KCC2 portfolio represents the only small molecule library within the broad biopharmaceutical industry that directly activates this unique ion cotransporter.
+Added: Other companies have attempted to activate KCC2;
+Added: to our knowledge, no others have been successful.
+Added: However, some may potentiate the cotransporter, which will likely have different clinical effects.
KCC2 direct activator library
−Removed: Our KCC2 direct activator portfolio includes four programs in active characterization and development, which we believe are suitable for pharmaceutical development.
+Added: Our KCC2 direct activator portfolio includes two programs in active characterization and development, which we believe are suitable for pharmaceutical development.
We have characterized and translated multiple candidates from the KCC2 portfolio for development in epilepsy as well as other possible neurological conditions associated with psychiatric, neurodegeneration and neurodevelopmental disorders.
Phenotypic screens and confirmatory animal disease models suggest that our programs, including:
−Removed: OV350, OV4071 and OV4041, have potential therapeutic properties associated with anti-psychosis, anxiolytic and anticonvulsant response.
+Added: OV4071 and other undisclosed molecules, have potential therapeutic properties associated with antipsychotic, anxiolytic and anticonvulsant response.
We have also determined that the unique molecules in the library are amenable to a range of formulations, including intravenous, oral and intramuscular injections.
−Removed: For the next three to four years, we anticipate filing regulatory submissions for human trials annually for successive programs emerging from our KCC2 portfolio.
−Removed: As noted above, these programs represent opportunities for in-house development or co-development and out-licensing.
−Removed: 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.
−Removed: OV350, OV4071 and OV4041
−Removed: In the first quarter of 2025, OV350 IV initiated first-in-human studies, which will assess class safety, tolerability and exploratory biomarkers for clinical change via quantitative EEG.
−Removed: We expect to announce topline results in the fourth quarter of 2025.
−Removed: It is our intent to develop OV350 as well as OV4071 and OV4041, oral programs that behave similarly in phenotypical screens, for the treatment of psychosis in people with NSD and LBD.
+Added: Over the next three years, we anticipate filing regulatory submissions for human trials annually for successive programs emerging from our KCC2 portfolio.
+Added: As noted above, these programs represent opportunities for in-house
+Added: development, co-development or out-licensing.
+Added: The library of early-stage small molecules that target KCC2, including OV4071, 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.
+Added: In 2025, we completed first-in-human studies of OV350 IV, for which topline data results were announced in the fourth quarter.
+Added: The data demonstrate a favorable safety profile, no treatment-related SAEs, and indicate central activity and spectral power consistent with expected physiological effects of KCC2 modulation aligned with potential drug exposure in the brain.
+Added: In 2025, we elected to prioritize and direct our capital resources to accelerate chronic (oral) formulations of our oral direct activator programs, including OV4071.
+Added: Accordingly, we do not intend to advance OV350 further in the clinic.
+Added: We believe the results from OV350 support the advancement of our portfolio of KCC2 direct activators, including OV4071.
+Added: We intend to initiate a Phase 1 clinical study of OV4071 in the second quarter of 2026 following receipt of HREC approval and acknowledgment of our CTN from the TGA.
+Added: The Phase 1 clinical trial will study multiple dose levels in as ascending single and multiple dose trial.
As noted above, these conditions have deep unmet patient need and are underserved by the current standard of care.
−Removed: Furthermore, in vivo proof-of-concept studies have established that restoring KCC2 activity reduced psychotic behaviors in animals (see Figure 5 below).
−Removed: Preclinical mechanistic studies have also demonstrated that OV350, OV4071 and OV4041 were well-tolerated and did not induce sedation.
+Added: Furthermore, in vivo POC studies have established that restoring KCC2 activity reduced psychotic behaviors in animals (see Figure 5 below).
+Added: Preclinical mechanistic studies have also demonstrated that OV4071 was well-tolerated and did not induce sedation.
OV350 demonstrates antipsychotic effects in schizophrenia model
−Removed: OV888 (GV101) – A highly selective ROCK2 inhibitor
−Removed: 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.
−Removed: The collaboration includes the development of lead program OV888 (GV101), which is a small molecule ROCK2 inhibitor in clinical stage studies.
−Removed: 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.”
−Removed: OV888 (GV101) is a potent blood-brain-barrier (“BBB”) penetrant inhibitor that is highly selective for ROCK2.
−Removed: ROCK2 is expressed abundantly in skeletal muscles and in the brain and is believed to primarily function to regulate intracellular cytoskeletal organization.
−Removed: We believe that the ROCK2 signaling pathway may be hyperactive 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.
−Removed: 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 present unwanted side effects.
−Removed: The initial indication for OV888 (GV101) is desired to be CCM, for which there is strong mechanistic evidence for inhibiting ROCK2, though this program is currently on pause pending regulatory feedback on another competitive clinical-stage development program for CCM.
−Removed: CCM is one of the most common intracranial vascular malformations in humans, presenting as mulberry-shaped abnormal blood vessels with thin, leaky walls located in the brain and/or spinal cord.
−Removed: It is thought CCM affects approximately 1 in 250 individuals.
−Removed: 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.
−Removed: As noted above, preclinical and human safety studies evaluating OV888 (GV101) demonstrated that it has a favorable toxicology profile with no serious adverse events reported.
−Removed: We will evaluate next steps and additional studies with OV888 pending review of emerging data from competitor and academic studies in CCM.
License and Collaboration Agreements
−Removed: In-licensing and Collaboration Agreement with Graviton Bioscience Corporation (2023)
−Removed: 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.
−Removed: 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
−Removed: (GV101) as well as a portfolio of ROCK2 inhibitors in mutually agreed-upon rare CNS indications, excluding amyotrophic lateral sclerosis.
−Removed: The agreement provides us with worldwide rights, excluding China, Hong Kong, Macau and Taiwan.
−Removed: 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.
−Removed: We are responsible for development and commercialization costs, post-Phase 2 development and commercialization of subsequent products.
−Removed: 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.
−Removed: Graviton retains rights to licensed products in all fields of study outside of rare brain disorders.
−Removed: We will evaluate next steps and additional studies with OV888 pending review of emerging data from competitor and academic studies in CCM.
Research Collaboration and Equity Investment in Gensaic (2022)
Under the terms of an equity agreement, we invested a total of $5.1 million in exchange for convertible preferred stock in Gensaic, Inc.
−Removed: Jeremy Levin, our Chairman and CEO, is a director of Gensaic.
+Added: Levin, our Executive Chairman, is a director of Gensaic.
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 tissue-selective intracellular delivery platform.
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We also retained rights to invest in future equity financing rounds.
+Added: In January 2026, the Gensaic Collaboration Agreement was amended to allow for identification of a new research project target in order to utilize the remaining prepaid funds from the original agreement, with additional immaterial provisions to the agreed-upon terms.
Royalties Associated with Marinus Out-License Agreement (2022)
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Following the date of regulatory approval by the FDA of the first licensed product in the territory, which was received on March 18, 2022, Marinus issued, at the Company’s option, 123,255 shares of Marinus common stock, par value $0.001 per share.
−Removed: The Marinus License Agreement also provides for payment of royalties from Marinus to us in single digits on net sales of each such licensed product sold.
+Added: The Marinus License Agreement also provided for payment of royalties from Marinus to us in single digits on net sales of each such licensed product sold.
In January 2025, Marinus was acquired by Immedica Pharma, S.A.
−Removed: Healx License and Option Agreement (2022)
−Removed: In February 2022, we entered into an exclusive license option agreement (“Healx Agreement”) with Healx, Ltd (“Healx”).
−Removed: 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.
−Removed: In February 2023, we amended the Healx Agreement to extend the option period by three months.
−Removed: At the end of the option period, Healx had 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.
−Removed: 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.
−Removed: 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.
−Removed: Healx assumed all responsibility for and costs of development of gaboxadol in June 2023.
−Removed: Healx will also be responsible for all commercialization costs of gaboxadol following the grant of a commercial license upon payment of the Option Fee.
−Removed: 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.
−Removed: We do not plan to conduct further trials of gaboxadol.
+Added: (“Immedica”).
+Added: In June 2025, we entered into an amendment to the Marinus License Agreement and received $7.0 million in cash to replace ongoing royalty payment obligations on sales of ganaxolone, as well as the right to add additional patents to the licensed portfolio within the following six months.
+Added: In December 2025, the right to add additional patents to the licensed portfolio lapsed without any additions.
Exclusive In-Licensing Agreement with AstraZeneca (2021)
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In exchange for an upfront payment of $5.0 million in cash and $7.3 million in shares of our common stock to AstraZeneca, we are responsible for using commercially reasonable efforts to carry out all future development and commercialization of KCC2 transporter activators in epilepsies and potentially other neuropathic conditions.
−Removed: We are obligated to pay AstraZeneca potential clinical development milestones of up to $8.0 million, regulatory milestones of up to $45.0 million and total commercial milestones of up to $150.0 million, as well as tiered royalty payments ranging from
−Removed: the single digits up to ten percent on net sales.
+Added: We are obligated to pay AstraZeneca potential clinical development milestones of up to $8.0 million, regulatory milestones of up to $45.0 million and total commercial milestones of up to $150.0 million, as well as tiered royalty payments ranging from the single digits up to ten percent on net sales.
At the time of proof of clinical efficacy, AstraZeneca will have the right of first negotiation to opt in to co-develop and co-commercialize KCC2 transporter activators with Ovid.
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Lundbeck A/S (“Lundbeck”), which we subsequently amended in May 2019, and July 2020 (collectively, the “Lundbeck Agreement”).
−Removed: 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.
+Added: As part of the Lundbeck Agreement, we obtained from Lundbeck an exclusive (subject to certain reserved non-commercial rights), worldwide license to develop,
+Added: manufacture and commercialize OV101, also known as gaboxadol.
We subsequently closed our OV101 (gaboxadol) program in Angelman syndrome in early 2021.
−Removed: In February 2022, we entered into Amendment No.
−Removed: 3 to the Lundbeck Agreement (the “Amended Lundbeck Agreement”) to permit our performance under the Healx Agreement.
−Removed: 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.
−Removed: 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 proportion of the net profit share to Lundbeck.
Sales and Marketing
−Removed: Given our stage of development, we have not yet established a commercial infrastructure or distribution capabilities.
−Removed: However, we do have internal market access and commercial strategy capabilities that inform our pipeline strategy and execution.
−Removed: As our pipeline assets advances in the clinic, we intend to build focused capabilities to commercialize our programs.
+Added: Given our stage of development, we have not yet established commercial and distribution infrastructures.
+Added: However, we do have internal market access and commercial capabilities that inform our pipeline strategy and execution.
+Added: As our pipeline assets advance in the clinic, we intend to build focused capabilities to commercialize our programs.
In markets for which commercialization may be less capital efficient for us, we may selectively pursue strategic collaborations with third parties in order to maximize the commercial potential of our drug candidates.
Manufacturing and Supply
−Removed: We currently outsource all manufacturing, and we intend to use our collaborators and contract manufacturers for the foreseeable future.
−Removed: However, certain members of our management have broad experience in manufacturing, which we believe may provide a competitive advantage.
−Removed: The field of epilepsy and psychiatric medicines is highly fragmented.
+Added: We currently outsource all manufacturing, and intend to continue utilizing collaborators and contract manufacturers for the foreseeable future.
+Added: However, members of our management have broad experience in manufacturing, which we believe may provide a competitive advantage.
+Added: The fields of epilepsy, including FOS and DEEs such as TSC and IS, and psychiatric medicines are highly fragmented.
There is no one direct competitor, though there are others in the field of epilepsy who market to similar indications as we may explore.
Those include:
−Removed: UCB, Jazz Pharmaceuticals plc, Sage Therapeutics, Inc., SK Biopharmaceuticals Inc., Harmony Biosciences, and Xenon Pharmaceuticals, Inc.
+Added: UCB, Jazz Pharmaceuticals plc, SK Biopharmaceuticals Inc., Harmony Biosciences, and Xenon Pharmaceuticals, Inc.
These are our most direct competitors with respect to OV329.
−Removed: Our OV350 program is intended for the treatment of psychosis in people with NSD and LBD.
−Removed: The only existing medicine indicated for NSD is marketed by Acadia Pharmaceuticals Inc.
+Added: Our KCC2 programs are potentially intended for the treatment of psychosis associated with Parkinson’s disease and LBD, schizophrenia, and mood disorders.
+Added: The only existing medicine indicated for psychosis associated with Parkinson’s disease and LBD is marketed by Acadia Pharmaceuticals Inc.
We are aware of one other company seeking to develop KCC2 potentiators, which is Axonis Therapeutics, Inc.
−Removed: As it relates to OV888 (GV101), we believe Neurelis Inc.
−Removed: is our most direct competitor.
Drug development is highly competitive and subject to rapid and significant technological advancements.
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The primary competitive factors that will affect the commercial success of any drug candidate for which we may receive marketing approval include efficacy, safety and tolerability profile, dosing convenience, price, coverage and reimbursement.
−Removed: Many of our existing or potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of drug candidates, as well as in obtaining regulatory approvals of those drug candidates in the United States and in other countries.
+Added: Many of our existing or potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of drug candidates, as well as in obtaining regulatory approvals of those drug candidates in the United States and in other regions.
Our current and potential future competitors also have significantly more experience commercializing drugs that have been approved for marketing.
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Intellectual Property
−Removed: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our current and future drug candidates, novel discoveries, product development technologies and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights.
+Added: Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our current and future drug candidates, novel discoveries, product development technologies and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing upon our proprietary rights.
Our policy is to seek to protect our proprietary position by, among other methods, filing or in-licensing U.S.
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Moreover, many jurisdictions, including the United States, permit third parties to challenge issued patents in administrative proceedings, which may result in further narrowing or even cancellation of patent claims.
−Removed: We cannot provide assurance that any patents will be issued from our pending or any future applications or that any potentially issued patents will adequately protect our intellectual property.
−Removed: We have exclusively licensed a portfolio of issued U.S.
+Added: provide assurance that any patents will be issued from our pending or future applications or that any potentially issued patents will adequately protect our intellectual property.
+Added: We exclusively licensed a portfolio of issued U.S.
and international patents from Lundbeck directed to polymorphic forms of OV101 and their preparation and methods of manufacturing OV101.
We have also filed, and own, multiple patent families directed to methods of treatment and formulations with OV101.
−Removed: Subsequently, we have licensed much of this portfolio to Healx under the Amended Healx Agreement.
+Added: Subsequently, we have licensed much of this portfolio to Healx Ltd, and are not further developing OV101.
OV329 was in-licensed from Northwestern.
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We have also filed, and own, multiple patent families involving the synthesis of OV329 and methods of treatment with OV329.
−Removed: OV888 (GV101) was licensed from Graviton.
−Removed: The composition of matter patent for OV888 (GV101) expires in 2038 excluding any potential regulatory extensions.
−Removed: Graviton has also filed patents on methods of use with OV888 (GV101).
−Removed: A library of early-stage small molecules that target the KCC2 transporter, including OV350 was in-licensed from AstraZeneca.
+Added: A library of early-stage small molecules that target KCC2 was in-licensed from AstraZeneca.
The molecules 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.
−Removed: We have also filed, and own, multiple patent families directed to methods of treatment with KCC2 molecules, including OV350.
−Removed: In addition, we have a library of proprietary genetic sequences that target UBE3A, KIF1A, HNRNPH2, and PDP2RD.
+Added: We have also filed, and own, multiple patent families directed to methods of treatment with KCC2 direct activation.
We continue to expand our intellectual property portfolio to protect our library of potential development candidates.
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Since patent applications in the United States and certain other jurisdictions are maintained in secrecy for 18 months or potentially longer, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain of the priority of inventions covered by pending patent applications.
−Removed: Moreover, we may have to participate in Interference, Derivation, Reexam, Post-Grant Review, Inter Partes Review or Opposition proceedings brought by third parties or declared by the USPTO.
+Added: Moreover, we may have to participate in Interference, Derivation, Ex Parte Reexamination, Post-Grant Review, Inter Partes Review or Opposition proceedings, brought by third parties or declared by the USPTO.
Government Regulation
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Government Regulation
−Removed: In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act ( “ FDCA ” ) and its implementing regulations.
+Added: In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act 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.
−Removed: requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s
−Removed: refusal to approve pending New Drug Applications ( “ NDAs ” ) or Biologics License Applications ( “ BLAs ” ), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
+Added: requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications ( “ NDAs ” ), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug product may be marketed in the United States generally involves the following:
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• approval by an independent institutional review board ( “ IRB ” ) at each clinical site before each trial may be initiated;
−Removed: • 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;
−Removed: • submission to the FDA of an NDA or BLA;
+Added: • performance of adequate and well-controlled human clinical trials in accordance with current Good Clinical Practice ( “c GCP ” ) requirements to establish the safety and efficacy of the proposed drug product for each indication;
+Added: • submission to the FDA of an NDA;
• satisfactory completion of an FDA advisory committee review, if applicable;
−Removed: • 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;
−Removed: • FDA review and approval of the NDA or BLA.
+Added: • 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, and;
+Added: • FDA review and approval of the NDA.
Preclinical Studies
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Clinical Trials
−Removed: Clinical trials involve the administration of the investigational new drug to human patients under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research patients provide their informed consent in writing for their participation in any clinical trial.
+Added: Clinical trials involve the administration of the investigational new drug to human patients under the supervision of qualified investigators in accordance with cGCP requirements, which include the requirement that all research patients provide their informed consent in writing for their participation in any clinical trial.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated.
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• Phase 1 clinical trial:
−Removed: The drug is initially introduced into healthy human volunteers or patients with the targeted disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.
+Added: The drug is initially introduced into healthy human volunteers, or patients without the targeted disease or condition, and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.
• Phase 2 clinical trial:
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Marketing Approval
−Removed: 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.
−Removed: In most cases, the submission of an NDA or BLA is subject to a substantial application user fee.
+Added: 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 requesting approval to market the product for one or more indications.
+Added: In most cases, the submission of an NDA is subject to a substantial application user fee.
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.
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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.
−Removed: 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.
+Added: In addition, under the Pediatric Research Equity Act of 2003, 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.
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The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
−Removed: Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured.
+Added: Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured.
The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
−Removed: Additionally, before approving an NDA or BLA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.
+Added: Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with cGCP requirements.
After evaluating the application and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter.
−Removed: A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA or BLA and may require additional clinical or preclinical testing in order for the FDA to reconsider the application.
+Added: A complete response letter generally contains a statement of specific
+Added: conditions that must be met in order to secure final approval of the NDA and may require additional clinical or preclinical testing in order for the FDA to reconsider the application.
Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
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Orphan Drug Act
−Removed: Under the Orphan Drug Act of 1983, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug.
−Removed: Orphan drug designation must be requested before submitting an NDA or BLA.
−Removed: After the FDA grants orphan drug designation, the name of the sponsor, identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA.
+Added: Under the Orphan Drug Act of 1983, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug.
+Added: Orphan drug designation must be requested before submitting an NDA.
+Added: After the FDA grants orphan drug designation, the name of the sponsor, identity of the drug and its potential orphan use are disclosed publicly by the FDA.
The orphan drug designation does not shorten the duration of the regulatory review or approval process, but does provide certain advantages, such as a waiver of PDUFA fees, enhanced access to FDA staff and potential waiver of pediatric research requirements.
−Removed: If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full NDA or BLA, or an abbreviated NDA (“ANDA”) or biosimilar application, to market a drug or biologic with the same active moiety for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity.
−Removed: Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition.
+Added: If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full NDA, or an abbreviated NDA (“ANDA”), to market a drug with the same active moiety for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity.
+Added: Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.
Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the application user fee.
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In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies and are subject to periodic unannounced inspections by the FDA and state agencies for compliance with cGMP requirements.
−Removed: Changes to the manufacturing process
−Removed: are strictly regulated and often require prior FDA approval before being implemented.
+Added: Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.
FDA regulations also require investigation and correction of any deviations from cGMP requirements and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.
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government, state legislatures, and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.
+Added: For example, the United States Department of Health and Human Services (“HHS”) imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.
+Added: In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven years and single-source biologics that have been on the market for at least 11 years covered under Medicare as part of the Medicare Drug Price Negotiation Program.
+Added: Each year up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program.
+Added: Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.
+Added: If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize any product candidates for which we receive approval, which could have an adverse effect on our operating results and our overall financial condition.
Third-party payors decide which therapies they will pay for and establish reimbursement levels.
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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;
−Removed: the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the U.S.
−Removed: 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.
+Added: the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to 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 Medicare, 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.
−Removed: 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.
−Removed: The PPACA, among other things, established an annual, nondeductible fee for 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 governments 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 framework for follow-on biologic products.
+Added: 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.
Since its enactment there have been executive, judicial and congressional challenges to certain aspects of the PPACA.
−Removed: On August 16, 2022, the Inflation Reduction Act of 2022 ( “ IRA ” ) was signed into law, which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025.
−Removed: The IRA also eliminated 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.
−Removed: It is possible that the PPACA
−Removed: will be subject to judicial or congressional challenges in the future.
−Removed: It is unclear how any such challenges and the healthcare reform measures of the current administration will impact the PPACA and our business.
−Removed: In addition, other legislative changes have been proposed and adopted since the PPACA was enacted.
−Removed: In August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions.
−Removed: The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs.
−Removed: 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.
−Removed: Further, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which have resulted in several presidential executive orders, congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
−Removed: At the federal level, the IRA, among other things, (i) directs the U.S.
−Removed: Department of Health and Human Services (“HHS”) to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least 7 years and biologics that have been on the market for at least 11 years covered under Medicare (the “Medicare Drug Price Negotiation Program”), and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
−Removed: These provisions began to take effect progressively starting in fiscal year 2023.
−Removed: On August 15, 2024, HHS announced the agreed-upon price of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges.
−Removed: On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025.
−Removed: Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.
−Removed: Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act was announced.
−Removed: 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.
−Removed: While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.
−Removed: Additionally, in the United States and some foreign jurisdictions there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system in an effort to contain costs, improve quality, and expand access to care, particularly in light of the recent U.S.
−Removed: presidential and congressional elections.
−Removed: These reform initiatives may, among other things, result in modifications to the aforementioned laws and/or the implementation of new laws affecting the healthcare industry.
+Added: For example, on July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which narrowed access to PPACA marketplace exchange enrollment and declined to extend the PPACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.
+Added: The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.
+Added: Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired PPACA subsidies.
+Added: In the United States, we expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.
+Added: The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, the United States Centers for Medicare & Medicaid Services (“CMS”) and related agencies.
+Added: These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.
+Added: For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a
+Added: direct-to-consumer platform, U.S.
+Added: patients in the United States and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.
+Added: Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;
+Added: (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products;
+Added: (3) imposing tariffs on imported pharmaceutical products;
+Added: and (4) as part of the Make America Healthy Again (“MAHA”) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.
+Added: Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager (“PBM”) payment methodologies, among other things.
+Added: These actions and policies may significantly reduce drug prices in the United States, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.
+Added: In June 2024, in Loper Bright Enterprises v.
+Added: Raimondo, the United States Supreme Court greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.
+Added: Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.
+Added: These and other reform initiatives may, among other things, result in modifications to the aforementioned laws and/or the implementation of new laws affecting the healthcare industry.
Human Capital Management
−Removed: As of December 31, 2024, we had 23 full-time employees, the majority of whom were primarily engaged in research and development activities, including two individuals with M.D.
−Removed: degrees and seven professionals with Ph.D.
−Removed: degrees specializing in the sciences.
+Added: As of December 31, 2025, we had 23 full-time employees, the majority of whom were primarily engaged in research and development activities, including three individuals with MD degrees and eight professionals with PhD degrees specializing in the sciences.
Many of these professionals have extensive epilepsy and neurology experience.
In total, within our management team, we have colleagues who worked to shape the development or commercialization of a number of important marketed neurology drugs and ASMs, including:
−Removed: Ztalmy, Fintepla, Brineura, Gilenya, Tysabri and Tecfidera.
+Added: Zolgensma, Ztalmy, Fintepla, Brineura, Gilenya, Tysabri and Tecfidera.
We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees.
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Grounded in these guiding principles, we believe we have developed a collaborative and highly engaged environment where our colleagues feel respected and valued, and can contribute to their fullest potential.
−Removed: We have equity incentive plans that are designed to attract, retain and motivate selected employees, consultants and directors through the granting of equity-based compensation awards and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
−Removed: In addition, our governance is overseen by an independent and diverse Board of Directors who provide and complement our expertise to oversee the strategy and performance of our company.
−Removed: Among our Board of Directors, four out of five members are independent.
+Added: We maintain equity incentive plans that are designed to attract, retain and motivate selected employees, consultants and directors through the granting of equity-based compensation awards and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
+Added: In addition, our governance is overseen by an independent board of directors who provide and complement our expertise to execute the strategy and performance of our company.
+Added: Among our board of directors, five out of seven members are independent.
Collectively, our board of directors provides insight and expertise in areas of importance to the performance and growth of our enterprise, including experience as:
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and corporate governance.
−Removed: We lease the space for our principal executive offices, which are located at 441 Ninth Avenue, 14th Floor, New York, New York.
+Added: We lease the space for our principal executive offices, located in Hudson Yards, New York City.
In 2022, we formally instituted hybrid work policies.
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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.
−Removed: 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.
+Added: We make these filings available on our website (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.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.