Ovid Therapeutics : Corporate Presentation

Ovid Therapeutics

Corporate Presentation

JUNE 2024

© Copyright 2024 Ovid Therapeutics

Forward looking statement

This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding timing for the the potential opportunity for soticlestat; the timing of potential regulatory filings and or regulatory decisions for soticlestat, and the potential for milestone and royalty payments from Takeda for soticlestat, statements regarding the timing for additional data readouts from Takeda evaluating soticlestat for Lennox-Gastaut and Dravet syndromes; discussions between Takeda and regulators related to the approval of soticlestat; success of Takeda's trials in soticlestat, Ovid's expectations regarding the duration its cash runway, and the expectation that it will support the advancement of Ovid's pipeline and Ovid's potential future business development opportunities; the timing and development of Ovid's product candidate pipeline and achievement of expected near- and long-term milestones; the potential therapeutic benefits of Ovid's current or future product candidates and pipeline programs; the potential development and therapeutic opportunity of OV888; and the potential safety, selectivity and potency of OV888 and other ROCK2 inhibitors; the potential use of OV888 and other ROCK2 inhibitors to treat cavernous cerebral malformations and other rare central nervous system disorders; the potential timing of the pivotal formulation for OV888; the potential timing of clinical studies for OV888 and the resulting data; the reporting of data for the potential Phase 1 study in healthy volunteers for OV329; the potential use of OV329 to treat rare and treatment-resistant forms of epilepsy and seizures; the clinical and regulatory development of OV329, including the anticipated timing of clinical trials of OV329; the likelihood that data for OV329 will support future development and therapeutic potential; the potential development of OV350 and other KCC2 compounds in the Company's library; the potential timing of a potential IND filings for OV329 and OV350; the suitability of the Company's library of novel, direct KCC2 transporter activators for a range of formulations and administrations that would make it possible to pursue both chronic and acute epilepsies; Ovid's business development intentions; the success of any licensing or partnering opportunities; the success, timing, ability to attract and maintain strategic collaborations; the clinical and regulatory development and potential commercialization of soticlestat, OV888, OV329, OV350, or any of Ovid's other current or future product candidates and pipeline programs and market opportunities. You can identify forward-looking statements because they contain words such as "will," "may," "plan," "believes," intends," "anticipates," "design", "target," "seek," "expects," "demonstrates," "observe," and "potential," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances).

Forward-looking statements are based on Ovid's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, risks related to Ovid's ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its technology or its business strategy, risks related to Ovid's ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions and risks to Ovid's or any of its partners' abilities to meet anticipated deadlines and milestones. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption "Risk Factors" in Ovid's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 14, 2024, and in future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

©2024 Ovid Therapeutics | All Rights Reserved		2

NOVEL BIOLOGICAL TARGETS

Modulated by potential first-in-class or best-in-class mechanisms of action

DIFFERENTIATED

PIPELINE

Intended to treat rare epilepsy & brain conditions

HARNESSING A SCIENTIFIC REVOLUTION

Applying highly specific small molecules for the central nervous system (CNS)

4	CLINICAL &
REGULATORY

MILESTONES

From Ovid's pipeline expected by 2025

Potential to be a leading rare epilepsy & brain disorder company

©2024 Ovid Therapeutics | All Rights Reserved		3

Differentiated pipeline with cadence of value-driving events

PROGRAMS

ROCK2 PLATFORM & OV8881

Selective ROCK2 inhibitor Collaboration with:

OV329 ORAL

GABA-aminotransferase inhibitor

OV329 INTRAVENOUS

GABA-aminotransferase inhibitor

KCC2 PLATFORM & OV350

KCC2 transporter activator

SOTICLESTAT

Cholesterol 24-hydroxylase inhibitor

Out-licensed to:

	INDICATION/TARGET	PRECLINICAL	PHASE 1	PHASE 2	PHASE 3	ANTICIPATED MILESTONES
	Cerebral cavernous malformations					• MAD completed; safety
					findings in H1 2024
	Undisclosed rare CNS indications
					• Phase 2 initiating in H2 2024
	Oral formulation for chronic					• Phase 1 readout in H2 2024
	treatment of epilepsies
	IV formulation for acute treatment					• IND in H2 20242
	of seizures
	Resistant epilepsies and other					• IND for OV350 in H2 20242
	neurological conditions

Dravet syndrome	COMPLETE	• Topline results available
		• Reviewing totality of data
Lennox-Gastaut syndrome	COMPLETE	with health regulators

UNDISCLOSED INDICATIONS OUTSIDE SEIZURES THAT MAY PROVIDE BUSINESS DEVELOPMENT OPPORTUNITY

©2024 Ovid Therapeutics | All Rights Reserved		4

Financial summary & upcoming milestones

Cash balance $90.3 million

As of March 31, 2024

Expected to support runway into H1 2026

Shares outstanding

70.9 million

As of May 10, 2024

Pipeline Milestones

	Key	Anticipated
	Milestones	Timing
OV888	Phase 1 MAD study	H1 2024
Top Line results
OV888	Initiate Phase 2 signal-	H2 2024
finding trial in CCM
OV329	Results of Phase 1 SAD/
MAD with MRS and TMS	H2 2024
	biomarkers
OV329	IND for IV formulation	H2 2024
submitted
KCC2 & OV350	IND for IV formulation	H2 2024
submitted

©2024 Ovid Therapeutics | All Rights Reserved		5

Soticlestat

Sold rights back to Takeda Pharmaceuticals

© Copyright 2024 Ovid Therapeutics

6

Overview

• Soticlestat is a potential novel inhibitor of cholesterol 24-hydroxylase that is thought to control seizures by reducing:
• • Over-activatedglutamatergic signaling; neuronal hyperexcitability
  • Inflammation
• Ovid co-developed soticlestat with Takeda from preclinical trials through to Phase 2
• Sold rights back to Takeda in 2021*
• Takeda conducted & completed two, Phase 3 trials:
• • SKYWAY in Lennox-Gastaut syndrome
  • SKYLINE in Dravet syndrome
• If Takeda secures regulatory approval for soticlestat, Ovid may receive potential milestones and royalties

*Ovid sold its 50% share of rights back to Takeda

©2024 Ovid Therapeutics | All Rights Reserved		7

Topline SKYLINE & SKYWAY results

	DRAVET SYNDROME	LENNOX-GASTAUT SYNDROME

Primary endpoint

• Soticlestat narrowly missed primary endpoint of reduction from baseline in convulsive seizure frequency vs. placebo (p-value= 0.06)
• Soticlestat showed, in a pre-specified subgroups of patients, significant treatment effects on the primary efficacy endpoint,

• Soticlestat missed its primary endpoint in reduction in major motor drop seizure

Secondary	6 key secondary endpoints showed clinically meaningful and	• Some secondary endpoints showed
endpoints	significant results (all p-values≤ to 0.008)	significant treatment effects
	•	Responder rate
	•	Caregiver and clinician global impression of improvement scales
	• Seizure intensity and seizure duration scales
Safety		Favorable safety and tolerability profile consistent with prior trials
Pooled analysis	• Soticlestat showed reduction from baseline in convulsive seizure	• N/A
with Phase 2		frequency compared to placebo (p-value=0.001)

Takeda moving forward to discuss the totality of the data with regulatory authorities

1. Takeda data on file

©2024 Ovid Therapeutics | All Rights Reserved		8

OV888

(GV101)

A highly selective ROCK2 inhibitor for potential treatment of cerebral cavernous malformations (CCM) & other CNS disorders

© Copyright 2024 Ovid Therapeutics

9

OV888 (GV101)

Highly selective ROCK2 inhibitor for rare neurological conditions

POTENTIAL OPPORTUNITY

Potential 1st and best-in-class disease modifying treatment for CCM

Well characterized safety profile in humans

Large addressable population with no pharmacological treatment

Mechanism applicable for other CNS conditions

STATUS

Completed Phase 1 safety study

• Pivotal gel capsule formulation
• Healthy volunteer study
• No SAEs observed

Potential 1st indication: CCM

~70x more selective for ROCK2 than NRL-10491

Intend to initiate patient signal finding trial in H2 2024

1. Based on analysis of OV888 and NRL-1049 biochemical assays

©2024 Ovid Therapeutics | All Rights Reserved		10