OVID Provides Update on OV101 Program and the Prioritization of its Resources
April 19 2021 - 8:00AM
Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical
company committed to developing medicines that transform the lives
of people with rare neurological diseases, today announced an
update on its OV101 program and the prioritization of its resources
to focus on the development of its robust early-stage pipeline,
including OV882, a short hairpin RNA therapy targeting UBE3A gene
expression in neurons, as a potential treatment for Angelman
syndrome. As part of this update, Ovid will discontinue development
of OV101 (gaboxadol), a delta (δ)-selective GABAA receptor
agonist, in Angelman syndrome. Furthermore, Ovid does not plan to
initiate further clinical studies of OV101 in Fragile X syndrome.
Following these updates, Ovid is reiterating its previous guidance
of anticipated quarterly operating expenses, excluding non-cash
expenses, to be in the range of $8 million to $10
million starting in the second quarter of 2021.
“Ovid has always taken a disciplined approach to
its investments, with a keen focus on achieving the highest level
of return,” said Jeremy M. Levin, DPhil, MB, BChir, Chairman and
Chief Executive Officer of Ovid Therapeutics. “While we are
disappointed in the outcome for OV101, our resources are now
squarely focused on a very promising pipeline in rare neurological
diseases, including Angelman syndrome. This focus is supported by
the significant resources delivered through our agreement with
Takeda for soticlestat, a program in which we maintain substantial
financial interest and no additional financial obligations. Ovid
would like to thank everyone who participated in our OV101 clinical
trials, including those with Angelman syndrome and Fragile X
syndrome, families and investigators, to whom we remain committed
to finding solutions for rare neurological disorders.”
As announced on March 30, 2021, Ovid closed a Royalty, License
and Termination agreement with Takeda Pharmaceutical Company
Limited under which Takeda secured global rights from Ovid to
develop and commercialize the investigational medicine soticlestat
(TAK-935/OV935) for the treatment of developmental and epileptic
encephalopathies. Under the agreement, Ovid received or is eligible
to receive meaningful financial consideration, including an upfront
payment of $196 million, up to $660 million in development,
regulatory and sales milestones, and tiered double-digit royalties
up to 20 percent on sales of soticlestat, if approved and
commercialized.
Our proforma cash, cash-equivalents and short-term investments
as of December 31, 2020 is over $250 million, reflecting the
receipt of the upfront payment from Takeda. These resources enable
a robust, long-term investment in the development of the Company’s
pipeline, and OVID’s ability to assess novel assets and
technologies that are complementary to this pipeline.
The decision to discontinue clinical study of
OV101 in Angelman syndrome and Fragile X syndrome is based on the
totality of the clinical results generated to date, including
results from the STARS, NEPTUNE, ELARA, and ROCKET trials. While
OV101 was well tolerated, with no significant safety signals
observed, the Company believes that efficacy outcomes observed in
these trials do not support its further development in these
conditions.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New
York-based biopharmaceutical company using its BoldMedicine®
approach to develop medicines that transform the lives of patients
with rare neurological disorders. We believe these disorders
represent an attractive area for drug development as the
understanding of the underlying biology has grown meaningfully over
the last few years and today represents a substantial opportunity
medically and commercially. Based on recent scientific advances in
genetics and the biological pathways of the brain, we aim to
identify, discover and acquire novel compounds for the treatment of
rare neurological disorders. We have built a deep knowledge of such
disorders, how to treat them and how to develop the clinically
meaningful endpoints required for development of a compound in
these disorders. We continue to execute on our strategy to build
this pipeline by discovering, in-licensing and collaborating with
leading biopharmaceutical companies and academic institutions.
Ovid’s emerging pipeline programs include OV329, a small molecule
GABA aminotransferase inhibitor for seizures associated
with Tuberous Sclerosis Complex and Infantile Spasms;
OV882, a short hairpin RNA therapy approach for Angelman syndrome;
OV815, a genetic therapy approach for KIF1A associated neurological
disorder; and other non-disclosed research targets. Additionally,
Ovid maintains a financial interest in OV935 which is now being
developed by Takeda. For more information on Ovid, please
visit www.ovidrx.com.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the clinical and regulatory
development and commercialization of Ovid’s programs and the
potential value and benefits of the Royalty, License and
Termination Agreement with Takeda, Ovid’s expectations regarding
its operating expenses, and use of its cash, cash equivalents and
short-term investments to development the Company’s pipeline. You
can identify forward-looking statements because they contain words
such as “will,” “appears,” “believes” and “expects.”
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 Ovid’s ability to discover and successfully
complete preclinical and clinical development of, obtain regulatory
approval for, and, if approved, successfully commercialize its
current and future drug candidates in a timely manner,
uncertainties in the development and regulatory approval processes,
the fact that initial data from pre-clinical and clinical trials
may not be indicative, and are not guarantees, of the final results
of the trials and are subject to the risk that one or more of the
clinical outcomes may materially change as patient enrollment
continues and/or more patient data become available. Additional
risks that could cause actual results to differ materially from
those in the forward-looking statements are set forth in Ovid’s
filings with the Securities and Exchange Commission under
the caption “Risk Factors.” Such risks may be amplified by the
COVID-19 pandemic and its potential impact on Ovid’s business and
the global economy. Ovid assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Contacts
Investors and Media:Ovid Therapeutics
Inc.Investor Relations & Public Relationsirpr@ovidrx.com
OR
Investors:Argot PartnersDawn
Schottlandt212-600-1902ovid@argotpartners.com
Media:Dan Budwick1ABdan@1abmedia.com
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