UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
Graviton Collaboration and License Agreement and Equity Purchase
On April 30, 2023, Ovid Therapeutics Inc. (the “Company”) entered into an exclusive Collaboration and License Agreement (the “Graviton Collaboration Agreement”) with Graviton Bioscience Corporation (“Graviton”), pursuant to which Graviton granted the Company rights to exclusively develop and commercialize products containing GV101 and other small-molecule compounds from Graviton’s library of ROCK2 inhibitors (each, a “Licensed Product”), for the treatment of orphan diseases associated with the central nervous system (“Field”). The Company’s rights are worldwide except for Mainland China, Hong Kong, Macao, and Taiwan (the “Territory”). Graviton will retain exclusive rights to the Licensed Products outside of the Territory and inside the Territory outside of the Field.
Promptly after execution of the Graviton Collaboration Agreement, the Company will purchase $10 million worth of Graviton’s Series A Preferred Stock. In addition, under the Graviton Collaboration Agreement, the Company will be obligated to pay tiered percentage royalties on a Licensed Product-by-Licensed Product basis ranging from the mid-teens to high-teens on annual net sales of each Licensed Product in the Territory, subject to adjustment in specified circumstances. The Company will also be responsible for all costs related to the development and commercialization of the Licensed Products in the Field in the Territory.
Pursuant to the terms of the Graviton Collaboration Agreement, on a Licensed Product-by-Licensed Product basis, Graviton will be responsible for conducting all development activities for a Licensed Product in the Field in the Territory through completion of the first phase 2 clinical trial for such Licensed Product, in accordance with a mutually agreed-upon development plan and development budget. The Company will be responsible for all further development and for commercialization of each Licensed Product in the Field in the Territory. Subject to specified exceptions, during the term of the Graviton Collaboration Agreement, Graviton has agreed that neither it nor its affiliates will exploit any product containing the same compound as a Licensed Product in the Field in the Territory. In addition, Graviton has agreed that, from and after initiation of IND-enabling studies for a Licensed Product, neither it nor its affiliates will exploit the compound that is contained in such Licensed Product in the Territory unless such compound is in a formulation that is unique from such Licensed Product.
The Graviton Collaboration Agreement will continue on a Licensed Product-by-Licensed Product and country-by-country basis until expiration of the royalty term for such Licensed Product in such country. Thereafter, the Company will have a fully paid up, perpetual, irrevocable, and royalty free license to certain intellectual property from Graviton for such Licensed Product in such country. Subject to the terms of the Graviton Collaboration Agreement, the Company may terminate the Graviton Collaboration Agreement in its entirety for convenience. In addition, Graviton may terminate the Graviton Collaboration Agreement under specified circumstances if the Company or certain other parties challenge Graviton’s patent rights, subject to specified exceptions. Either party may terminate the Graviton Collaboration Agreement for the other party’s uncured material breach or insolvency and the Company also has the right to, in lieu of terminating for an uncured material breach by Graviton, elect not to terminate and instead reduce the royalty payments under the Graviton Collaboration Agreement.
The foregoing description of the material terms of the Graviton Collaboration Agreement is qualified in its entirety by reference to the complete text of the Graviton Collaboration Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission (“SEC”) as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending on June 30, 2023.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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OVID THERAPEUTICS INC. |
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Date: |
May 1, 2023 |
By: |
/s/ Thomas M. Perone |
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Thomas M. Perone |
Exhibit 99.1
Ovid Therapeutics Announces Collaboration with Graviton Bioscience, Proven Developers of Selective ROCK2 Inhibitors
NEW YORK, May 1, 2023 – Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company developing medicines designed to conquer epilepsies and meaningfully improve the lives of people affected by brain disorders, and Graviton Bioscience Corporation, a privately held early-stage drug development company specializing in therapeutics that inhibit Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2), today announced a collaboration agreement to innovate novel medicines that they believe will significantly change the treatment paradigm for serious, rare neurological diseases.
The agreement supports Ovid’s strategy of building a pipeline of first-in-class and best-in-class mechanisms for seizure-related disorders. Specifically, the collaboration will advance clinical development of GV101, which is currently in a Phase 1 trial, along with other selective, small-molecule compounds from a library of ROCK2 inhibitors that have shown blood-brain barrier penetrance in animals. Together, the companies intend to develop ROCK2 inhibitors for the treatment of a broad range of neurological conditions marked by seizures, spasms and related symptoms. Initial clinical development is anticipated to address cavernous malformations in the brain, for which there is strong mechanistic evidence for inhibiting ROCK2. The collaborators intend to harness the expertise held by the team at Graviton, who previously pioneered the development of Rezurock,® the first approved ROCK2 inhibitor for graft vs. host disease, and Ovid’s development capabilities in rare brain conditions.
“This collaboration complements our pipeline with clinical and preclinical programs and represents an important step in achieving our strategy,” said Dr. Jeremy Levin, D.Phil, MB BChir., Chairman and CEO of Ovid Therapeutics. “We are excited to begin work with a combined team that is deeply experienced at identifying and accelerating new therapeutic technologies for unaddressed diseases.
ROCK2 inhibition is a completely novel mechanism of action for the brain, which we believe will open new therapeutic avenues and change the fate of patients.”
“Our ROCK2 inhibitor compounds have shown to be extraordinarily selective and potent in many preclinical studies, and as a result, we believe they may provide significant therapeutic benefit for a broad range of diseases, including neurologic, immunologic, fibrotic and genetic conditions,” remarked Samuel Waksal, Ph.D. and founder of Graviton. “Working alongside Ovid and a series of partners, we seek to accelerate our candidates into the clinic to rapidly elucidate the therapeutic potential of this portfolio. We believe and hope that ROCK2 inhibition will become a future mainstay in the treatment of people with severe brain conditions who have no medicines today.”
Under the terms of the agreement, Ovid will make an upfront payment of $10 million in exchange for Series A preferred stock of Graviton, subject to certain closing conditions. Ovid will have rights to develop GV101 as well as a portfolio of ROCK2 inhibitors owned or developed by Graviton in mutually agreed upon rare central nervous system indications worldwide, excluding China, Hong Kong, Macau and Taiwan. Additionally, Ovid CEO Dr. Jeremy Levin will serve on Graviton’s Board of Directors.
Graviton will be 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. Ovid will be responsible for: development and commercialization costs, post-Phase 2 development and commercialization of the products. Graviton will be eligible for percentage royalties in the mid- to high-teens based on net sales in territories where the products are marketed. Graviton retains rights to licensed products in all fields of study outside of rare brain disorders.
ROCK2 is a central phosphorylating kinase with isoform differences in tissue distribution. Specifically, the ROCK2/RhoA axis is expressed abundantly in skeletal muscles and in the brain. Published evidence suggests that the ROCK2 signaling pathway may be uniquely activated in multiple diseases, including conditions involving endothelial and autoimmune disorders. Ovid and Graviton have particular interest in neurological disorders involving vascular structures and nerve myelination diseases that can result in seizures, spasms and a variety of symptoms. Despite this link, historically there has been limited clinical development of ROCK2 inhibitors due to challenges penetrating the blood-brain barrier. Ovid and Graviton believe they have multiple selective and potent ROCK2 inhibitors that effectively penetrate the blood-brain barrier, which will be appropriate in future development indications.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science. Ovid’s pipeline of small molecule and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies. Ovid is developing OV329, a GABA-aminotransferase inhibitor, for treatment-resistant seizures and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies. In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes. For more information about these and other Ovid research programs, please visit www.ovidrx.com.
About Graviton Bioscience
Graviton Bioscience Corporation is a New York-based company founded in 2020 with the goal of developing novel therapeutics for the treatment of autoimmune, cancer, certain genetic, fibrotic and other serious diseases. Leading the company is Dr. Samuel Waksal, the founder and former Chairman and CEO of Kadmon Pharmaceuticals (NASDAQ: KDMN), where he led the licensing and early development of what is the first approved ROCK2 inhibitor, REZUROCK® (belumosudil). Kadmon was subsequently acquired by Sanofi. Dr. Waksal is also the founder and former CEO and President of ImClone Systems (acquired by Eli Lilly), a founder of MeiraGTx (NASDAQ: MGTX) and is the founder of Equilibre Biopharmaceuticals Corp.
About GV101
GV101 appears, in preclinical studies, to be a potentially highly selective, potent inhibitor of Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2) that may penetrate the blood-brain barrier. In preclinical studies, GV101 has demonstrated favorable safety and toxicology results compared to other ROCK2 selective inhibitors. It has completed a Phase 1, placebo-controlled, randomized, double-blind, single ascending dose study in healthy volunteers in the United States and has completed dosing for a Phase 1 study in China.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the reporting of the potential development and use of OV329, OV350 or soticlestat; the status of and expected timing for the completion of Takeda’s two pivotal Phase 3 trials evaluating soticlestat for Lennox-Gastaut and Dravet syndromes; the timing of anticipated filing for regulatory approval of soticlestat; the potential development of GV101 and other Rho/Rho associated coiled-coil containing protein kinase 2 inhibitors; and the potential safety, selectivity and potency of GV101 and other ROCK2 inhibitors. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expected,” “intends,” “plan,” “potential,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Takeda’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 clinical development and regulatory approval processes and the risk that Ovid may not be able to realize the intended benefits from its financial interest in soticlestat. 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 13, 2023, 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.
Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
Chief Corporate Affairs Officer
917-943-6681
malexander@ovidrx.com
Document And Entity Information |
May 01, 2023 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 01, 2023 |
Entity Registrant Name | Ovid Therapeutics Inc. |
Entity Central Index Key | 0001636651 |
Entity Emerging Growth Company | false |
Securities Act File Number | 001-38085 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 46-5270895 |
Entity Address, Address Line One | 441 Ninth Avenue |
Entity Address, Address Line Two | 14th Floor |
Entity Address, City or Town | New York |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10001 |
City Area Code | 646 |
Local Phone Number | 661-7661 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Trading Symbol | OVID |
Security Exchange Name | NASDAQ |
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