Ovid Therapeutics
March 2024
© Copyright 2024 Ovid Therapeutics
Forward looking statement
This presentation contains "forward-lookingstatements" within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the timing for the completion of Takeda's two pivotal Phase 3 trials evaluating soticlestat for Lennox-Gastautand Dravet syndromes; the potential timing of regulatory decisions on soticlestat; the success of Takeda's trials in soticlestat; the duration of the Company's cash runway, and the expectation that it will support the advancement of the Company's pipeline; 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 other Rho/Rho associated coiled-coilcontaining protein kinase 2 inhibitors; 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, OV329, OV350, OV888 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," "advance," "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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 8, 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-lookingstatements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
© Copyright 2024 Ovid Therapeutics | 2 | |
FOCUSED
PIPELINE
To treat epilepsy and conditions with seizure symptoms
HARNESSING | NOVEL |
A SCIENTIFIC | BIOLOGICAL |
REVOLUTION | TARGETS |
Targeted small | Modulated by |
molecules for the | potential first-in-class |
central nervous | or best-in-class |
system | mechanisms of action |
Well positioned to be a leading pipeline in seizures
Multiple milestones expected in next 15 months
- Clinical and regulatory milestones
expected from Ovid's pipeline by early 2025
- Two Phase 3 pivotal trials for soticlestat fully enrolled; data expected by or before September 2024 from Takeda
Differentiated pipeline & veteran team
- 3 potential first-in-class or best-in-class mechanisms of action
- Collective track record of developing and commercializing more than 25 medicines
- Proven dealmakers
Expected cash runway into 1H 2026
$105.8M in capital to fund company1
Eligible for additional non-dilutive capital3
Eligible to receive from Takeda:
- Up to $660 million in regulatory and commercial milestones
- Tiered double-digit royalties up to 20% on all global sales for any indications
- Ligand Pharmaceuticals receives 13% of all milestones and royalties Ovid receives from Takeda
- As of 12/31/23
- Received for 13% interest of potential milestones and royalties Ovid is eligible to receive from Takeda if soticlestat is approved and commercialized
- If soticlestat is successfully approved and commercialized
© Copyright 2024 Ovid Therapeutics | 4 | |
Differentiated pipeline of potential first-in-class or best-in-class mechanisms of action
PROGRAMS
INDICATION/TARGET | PRECLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | ANTICIPATED |
MILESTONES | |||||
SOTICLESTAT
Cholesterol 24-hydroxylase inhibitor
Out-licensed to
ROCK2 PLATFORM & OV8881
Selective ROCK2 inhibitor Collaboration with
OV329
GABA-aminotransferase inhibitor
In-licensed from:
OV329
GABA-aminotransferase inhibitor
In-licensed from
KCC2 PLATFORM & OV350
KCC2 transporter activators In-licensed from:
Dravet syndrome
Lennox-Gastaut syndrome
Cerebral cavernous malformations
Undisclosed rare CNS indications
Oral formulation for chronic treatment of epilepsies
IV formulation for acute treatment of seizures
Resistant epilepsies and other neuropathologies
- Phase 3 data from 2 registrational trials by or before September 2024
-
Filing marketing authorization submissions in Takeda's
FY 2024 - MAD completion H1 2024
- POC study initiation H2 2024
- Phase 1 target engagement, PD marker & safety H2 2024
- IND2 in H2 2024
- IND for OV350 in H2 2024
UNDISCLOSED ROCK2 INHIBITOR PROGRAMS
1. | Graviton is conducting development of OV888 (formerly GV101) through Phase 2, which will be directed by a Joint Development Committee that includes members of both Graviton and Ovid. | |||
2. | © Copyright 2024 Ovid Therapeutics | 5 | ||
Or equivalent regulatory application |
Robust clinical & regulatory milestones expected in next 15 months
PROGRAM MILESTONE | ANTICIPATED TIMING |
OV888
(GV101)
1
OV329
KCC2 &
OV350
Expected from
Soticlestat
Complete Phase 1 MAD study | H1 2024 |
Initiate signal-finding trial in CCM | H2 2024 |
Phase 1: SAD/MAD with MRS biomarker and TMS | H2 2024 |
(chronic) | |
IND2 for IV formulation (acute) | H2 2024 |
IND submission (IV formulation) | H2 2024 |
Phase 3 data for Lennox-Gastautsyndrome | Trials are fully enrolled; data expected by or |
Phase 3 data for Dravet syndrome | before September 2024 |
Regulatory submissions for Lennox-Gastaut syndrome | Takeda's FY 2024 (April 2024 - March 2025) |
and Dravet syndrome | |
Expected cash runway supports programs to and through milestones
1. | Milestones expected from Ovid 's pipeline by early 2025 | © Copyright 2024 Ovid Therapeutics | 6 | |
2. | Or equivalent regulatory application | |||
Significant medical need persists in epilepsy & seizures
Up to 1in10 | Pharmaco-resistant epilepsy common2 | ~47% | ||
humans will experience a | Pharmaco- | |||
seizure in their lifetime1 | Seizures | 47% | resistant epilepsy | |
controlled | 53% Seizures not | of epilepsy patients report | ||
by 1 ASM | controlled with | polypharmacy - | ||
≥ 2 ASMs | taking on average 5 medications3 |
50 | 3 | 470,000U.S. children |
million | million | ≤17 years |
Living with epilepsy across | adults living with | |
1 have epilepsy6 | ||
the globe4 | epilepsy in the US5 | |
- Epilepsy. World Health Organization. Updated February 9, 2022. Accessed July 12, 2022. https://www.who.int/news-room/fact-sheets/detail/epilepsy.
- Based upon UK Study of 525 individuals (9-93 years) with newly diagnosed epilepsy, followed for 5 years
3.Terman SW, Aubert CE, Hill CE, et al. Polypharmacy in patients with epilepsy: a nationally representative cross-sectional study. Epilepsy Behav. 2020;111:107261.
- World Health Organization epilepsy fact sheet updated in February 2023. https://www.who.int/news-room/fact-sheets/detail/epilepsy
- Epilepsy fast facts. Centers for Disease Contr Easl and Prevention. Updated September 30, 2020. Accessed July 12, 2022. https://www.cdc.gov/epilepsy/about/fast-facts.htm.
- Who can get epilepsy. Epilepsy Foundation. Updated February 4, 2022. Accessed February 9, 2023. https://www.epilepsy.com/what-is-epilepsy/understanding-seizures/who-gets-epilepsy.
© Copyright 2024 Ovid Therapeutics
$$
Reimbursement & coverage
dynamics remain favorable
Polypharmacy generally
well covered
7
Soticlestat
- potential first-in-class cholesterol 24 hydroxylase inhibitor for the potential treatment of Lennox-Gastaut syndrome & Dravet syndrome
Soticlestat Overview
- Potential first-in-class, selective inhibitor of cholesterol 24-hydroxylase
- Shows decreases in glutamatergic signaling to reduce seizure susceptibility and improve seizure control
- Completing one of the more robust development programs for developmental and epileptic encephalopathies (DEE)
- Demonstrated sustained seizure reduction efficacy, safety & tolerability with no anticipated monitoring in clinical trials to-date
Evidence of clinical findings included on subsequent slides.
© Copyright 2024 Ovid Therapeutics
STATUS
Phase 3 studies are fully enrolled; data expected by or before September 2024
Anticipated global regulatory
filings in Takeda's FY2024 (April 2024 - March 2025)
Initial indications being studied by Takeda in Phase 3 global studies:
- Lennox-Gastautsyndrome (SKYWAY trial)
- Dravet syndrome (SKYLINE trial)
9
Soticlestat
Potential milestones & royalties from Takeda can provide significant additional non-dilutive capital
2021
Upfront payment
- All Ovid financial obligations for soticlestat are terminated
2024 -2025*
Phase 3 data & expected regulatory decisions
- Takeda funding comprehensive LGS and Dravet trials
- Soticlestat is leading neuroscience Phase 3 program for Takeda1
Est. 2025 and later* Commercial milestones & royalties
- Tiered double-digit royalties on ALL indications
- Up to 20% on GLOBAL soticlestat sales
$196M
(Q1'21)
Up to $660M in additional milestones+
+ royalties (up to 20%)
+Potential for combined regulatory and commercial milestone payments
+Note: Ligand Pharmaceuticals has 13% interest in all milestones and royalties Ovid receives from Takeda.
FUNDS PIPELINE & BUSINESS DEVELOPMENT
*Estimated timing based upon Takeda's guidance that it anticipates regulatory filings in its fiscal year 2024.
1. Takeda Consolidated Development Pipeline by Phase Presentation. Accessed November 2022.
© Copyright 2024 Ovid Therapeutics | 10 | |
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Ovid Therapeutics Inc. published this content on 07 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 March 2024 13:07:02 UTC.