Ovid Therapeutics Reports Business Updates and Second Quarter 2024 Financial Results
August 13 2024 - 8:00AM
Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company
dedicated to improving the lives of people affected by rare
epilepsies and brain conditions, today reported business updates
and financial results for the second quarter ended June 30,
2024.
"Following Takeda's unexpected Phase 3 results
for soticlestat, we moved rapidly to focus our resources to
preserve capital. This approach included restructuring the
organization and initiating ongoing program prioritization efforts
to support the achievement of meaningful clinical and regulatory
milestones within our financial plan," explained Dr. Jeremy Levin,
D. Phil, MB BChir., Chairman and CEO. "We are thrilled that our
current pipeline remains on track to deliver anticipated results.
To further our strategic objectives, we welcomed Dr. Amanda Banks
as our Chief Development Officer. Her expertise, along with the
expanded Scientific Advisory Board, will enhance our ability to
capitalize on therapeutic opportunities and prioritize efforts
where we can most benefit patients."
General Corporate & Business
Updates
Ovid is streamlining its operations, while
seeking to optimize its pipeline programs and strengthen its
financial capital to focus on achieving near-term clinical
milestones. Key initiatives include:
-
Organizational restructuring: The Company
streamlined its workforce by reducing 17 positions, or 43% of its
headcount, to prioritize its core programs and extend its cash
runway. Ovid expects to incur $3.4 million of cash expenditures
related to the restructuring. The cash expenditures will be
completed by mid-2025.
- Financial
strategy: Ovid expects its cash runway to support
operations and clinical development through late H1 2026. During
this period, Ovid plans to achieve five clinical and regulatory
milestones and will explore partnerships and co-development
opportunities for select programs.
- Pipeline strategy &
prioritization: Ovid is actively evaluating its pipeline
and undertaking an ongoing process to review indication and
development strategies. As part of this process, the Company has
currently focused resources on advancing OV888/GV101 and OV329 oral
programs toward significant clinical milestones. It also paused the
intravenous (IV) OV329 program and other preclinical programs.
-
Talent strategy: In July, as part of Ovid's
corporate strategy, Dr. Amanda Banks was appointed Chief
Development Officer. Dr. Banks brings extensive expertise in
clinical and corporate development strategy and she will oversee
clinical execution, medical and regulatory affairs, and support
business development. Additionally, in July 2024, Ovid expanded its
Scientific Advisory Board and added distinguished neurologists,
neuroscientists, and epileptologists, including: Drs. Imad Najm,
Raman Sankar, Jamie McGuire, and Jeff Noebels. These experts
will help guide the application of Ovid’s novel mechanisms into
broader areas of neurology, for which they might offer potential
therapeutic benefits.
Pipeline Updates
Ovid is advancing pipeline programs including:
OV888/GV101, OV329 and OV350. Updates include:
-
OV888/GV101 capsule advancing to Phase 2 proof-of-concept
study in cerebral cavernous malformations (CCM): In June
2024, Ovid and its partner, Graviton Bioscience, announced topline
results from a Phase 1 clinical trial studying OV888/GV101 capsule.
The study met its objective, demonstrating a favorable safety and
tolerability profile with no serious adverse events. All
drug-associated clinical adverse events (AEs) were mild and
resolved. The most commonly reported clinical AE was headache (in
23% of participants), and all cases were transient and resolved.
The study additionally showed:
-
Target engagement. A dose dependent decrease in
proinflammatory cytokines IL-17 and IL-21 secretion by stimulated
peripheral blood mononuclear cells was observed. These decreases
indicate that rho-associated coiled- coil containing protein kinase
2 (ROCK2) inhibition is occurring and suggest that OV888/GV101 is
biologically active in humans at the target clinical dose and
elicits a pharmacodynamic response.
-
Exposure and half-life supportive of daily dosing.
OV888/GV101 capsule has an average half-life of approximately 12
hours, suggesting that it is suited for once daily dosing. A dose
dependent increase in Cmax and AUC0-24 was seen through the target
dose for Phase 2.
-
Timing of proof-of-concept study. Ovid and
Graviton Bioscience are on track to initiate a Phase 2
proof-of-concept program evaluating the safety and efficacy of
OV888/GV101 in H2 2024.
-
Timing for OV329 (oral) Phase 1 results: Ovid
anticipates the completion of a Phase 1 multiple ascending dose
(MAD) study of OV329 in H2 2024. That study is ongoing and applies
magnetic resonance spectrometry and transcranial magnetic
stimulation, respectively, as biomarkers of target engagement and
clinical efficacy. In addition, Ovid expects to present:
-
Ocular accumulation data at Epilepsy Foundation Pipeline
Conference 2024. In September 2024, Ovid expects to
present results from a pharmacokinetic study examining whether
OV329 has a similar tendency as vigabatrin to accumulate in rodent
eyeballs, and more specifically, the retina, after multiple days of
continuous infusion. The mechanistic insights gained from this
study may inform how OV329 could differentiate from vigabatrin
relative to ocular safety.
-
Suspending development of OV329 IV formulation. As
part of Ovid's ongoing portfolio prioritization efforts, the
Company has paused the OV329 IV program for refractory status
epilepticus.
-
OV350 regulatory submission and potassium chloride
co-transporter 2 (KCC2) direct activator
library. Ovid intends to submit an application to
study an IV formulation of OV350 in healthy human volunteers in H2
2024. OV350 is the first program emerging from Ovid’s novel
portfolio of KCC2 direct activators. The Company believes several
of its direct activators have the potential to treat multiple
diseases, including psychiatric and anticonvulsant indications,
thereby enabling possible partnering and co-development
opportunities.
-
Soticlestat: Following the release of topline
findings for soticlestat in June 2024, Takeda has stated that it
plans to engage with the FDA to explore a potential path forward
for soticlestat based upon the totality of the data generated in
Dravet syndrome across Phase 2 and Phase 3 programs. Takeda
reported in its June 2024 topline findings release that the SKYLINE
trial in Dravet narrowly missed its primary endpoint, though it
showed significance in pre-specified sub-populations and in certain
secondary endpoints. During Takeda's Q1 FY2024 earnings call, it
announced that soticlestat did not show clinical benefit for
patients with Lennox-Gastaut Syndrome (LGS) and that the
development in LGS has been discontinued.
-
Financial interest: Ovid retains a financial
interest in soticlestat following the sale of its 50% rights to
Takeda in March 2021. If soticlestat is approved and
commercialized, Ovid is eligible to receive regulatory and
commercial milestone payments, as well as tiered, low double-digit
royalties up to 20% on global net sales from Takeda. Of these
potential future payments, Ovid sold a 13% interest to Ligand
Pharmaceuticals for $30.0 million in October 2023. Ovid retains 87%
of its interest in any milestone payments and royalties. Ovid has
no ongoing obligations or costs associated with the development of
soticlestat.
Second Quarter 2024 Financial Results
- Cash,
cash equivalents and marketable securities as of June 30,
2024, totaled $77.0 million.
- Revenue
from royalty agreements were $169,000 for the second quarter ended
June 30, 2024, as compared to $75,000 in the same period in
2023.
- Research
and development expenses were $12.6 million for the second quarter
ended June 30, 2024, compared to $6.0 million in the same
period in 2023. The increase is related to advancement of Ovid's
clinical pipeline as described above, including the addition of the
OV888/GV101 Phase 1 MAD program and expanded OV329 clinical
development activities, as well as $1.6 million in one-time costs
due to organizational restructuring during the period.
- General
and administrative (G&A) expenses were $8.1 million for the
second quarter ended June 30, 2024, as compared to $8.2
million for the same period in 2023. G&A costs included a
one-time $1.8 million expense associated with the above mentioned
organizational restructuring.
- Total
operating expenses were $20.7 million for the second quarter ended
June 30, 2024, as compared to $14.2 million for the same
period last year, and included a total of $3.4 million of one-time
costs related to the above mentioned organizational
restructuring.
- Ovid reported a net income of $8.5
million, or basic and diluted net income per share attributable to
common stockholders of $0.12, for the second quarter of 2024, as
compared to a net loss of $12.4 million, or basic and diluted net
loss per share attributable to common stockholders of $0.18, for
the same period in 2023. Net income in the second quarter of 2024
included a $29.0 million gain due to a fair value adjustment to the
royalty monetization liability. Following the results of the two
pivotal studies that Takeda conducted with soticlestat, Ovid
reassessed assumptions about the fair value of the royalty
monetization liability. This reassessment led to a decrease in the
royalty monetization liability which is recognized in Ovid's second
quarter financial results.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based
biopharmaceutical company that is dedicated to improving the lives
of people affected by rare epilepsies and brain conditions with
seizure symptoms. The Company is advancing a pipeline of novel,
targeted small molecule candidates that modulate the intrinsic and
extrinsic factors involved in neuronal hyperexcitability causative
of seizures and other neurological symptoms. Ovid is developing:
OV888/GV101 capsule, a potent and highly selective ROCK2 inhibitor,
for the potential treatment of cerebral cavernous malformations and
other rare central nervous system diseases; OV329, a
GABA-aminotransferase inhibitor, a potential therapy for
treatment-resistant seizures; and OV350, a direct activator of the
KCC2 transporter, for the potential treatment of epilepsies and
other psychiatric conditions. For more information about these and
other Ovid research programs, please visit www.ovidrx.com.
Forward-Looking Statements
This press release includes certain disclosures
by Ovid that contain “forward-looking statements” including,
without limitation: statements regarding the potential success of
Ovid’s Scientific Advisory Board; Ovid’s ability to achieve
projected cost savings in connection with the organizational
restructuring and related pipeline prioritization efforts; Ovid’s
expectations regarding the duration of its cash runway and the
expectation that it will support the advancement of Ovid’s
pipeline; the expected timing of initiation of Ovid’s Phase 2
clinical programs studying OV888/GV101 in CCM; the expected timing
of completion of the Phase 1 MAD study of OV329 and expected timing
of data presentation; the potential use and development of
OV888/GV101, OV329, OV350 and compounds from Ovid’s library of
direct activators of KCC2; the potential therapeutic opportunity of
OV888/GV101, OV329, OV350 and compounds from Ovid’s library of
direct activators of KCC2; the potential opportunity for
soticlestat in Dravet syndrome and the outcome of Takeda's
interactions with regulators regarding marketing authorization for
soticlestat in Dravet syndrome; Ovid’s potential future business
development opportunities; the potential application of Ovid’s
pipeline programs and mechanisms of action to broader areas of
neurology; and other statements that are not historical fact. You
can identify forward-looking statements because they contain words
such as “anticipates,” “believes,” “expects,” “intends,” “may,”
“plan,” “potentially,” and “will,” 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,
impediments to Ovid’s ability to achieve projected cost savings in
connection with the organizational restructuring and related
pipeline prioritization efforts, 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, or
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. 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.
Condensed Consolidated Statements of
OperationsUnaudited |
|
(in thousands, except share and per share data) |
For The Three Months EndedJune 30,
2024 |
|
For The Three Months EndedJune 30,
2023 |
Revenue: |
|
|
|
License and other revenue |
$ |
169 |
|
|
$ |
75 |
|
Total revenue |
|
169 |
|
|
|
75 |
|
Operating expenses: |
|
|
|
Research and development |
|
12,582 |
|
|
|
5,999 |
|
General and administrative |
|
8,104 |
|
|
|
8,248 |
|
Total operating expenses |
|
20,686 |
|
|
|
14,247 |
|
Loss from operations |
|
(20,517 |
) |
|
|
(14,172 |
) |
Other income (expense),
net |
|
29,038 |
|
|
|
1,764 |
|
Income (loss) before provision
for income taxes |
|
8,521 |
|
|
|
(12,408 |
) |
Provision for income
taxes |
|
— |
|
|
|
— |
|
Net income (loss) |
$ |
8,521 |
|
|
$ |
(12,408 |
) |
Net income (loss) per share,
basic |
$ |
0.12 |
|
|
$ |
(0.18 |
) |
Net income (loss) per share,
diluted |
$ |
0.12 |
|
|
$ |
(0.18 |
) |
Weighted-average common shares
outstanding, basic |
|
70,916,471 |
|
|
|
70,534,181 |
|
Weighted-average common shares
outstanding, diluted |
|
71,200,798 |
|
|
|
70,534,181 |
|
Select Condensed Consolidated Balance Sheet
DataUnaudited |
|
(in thousands) |
June 30, 2024 |
|
December 31, 2023 |
Cash, cash equivalents and marketable securities |
$ |
76,974 |
|
$ |
105,834 |
Working capital(1) |
|
66,770 |
|
|
98,123 |
Total assets |
|
118,093 |
|
|
144,027 |
Total stockholder's
equity |
|
88,903 |
|
|
87,797 |
(1)Working capital
defined as current assets less current liabilities |
|
Contacts
Investor RelationsGarret
BonneyIR@ovidrx.com(617) 735-6093
MediaRaquel
CaboRCabo@ovidrx.com(646) 647-6553
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