Ovid Therapeutics Reports First Quarter 2022 Financial Results and Corporate Highlights
Ovidanticipates filing an investigational new drug application (IND) for OV329, a potent GABA aminotransferase inhibitor, and initiating Phase 1 trials in the fourth quarter of 2022
- Data supporting OV329 in rare and treatment-resistant epilepsies expected to be presented at the upcoming
EILAT XVIand Epilepsy Foundation Pipeline conferences
- Entered into an agreement with
Tufts Universityunder the direction of Professor Stephen Moss, a recognized leader in epilepsy research, to support advancement of the pipeline
- Multi-year cash and cash equivalents expected to support the progression of the current pipeline of differentiated epilepsy programs into 2025
“Ovid is focused on propelling our pipeline of potential medicines with novel mechanisms of action for epilepsies and seizures,” said
2022 Corporate Highlights & Anticipated Milestones
Ovidexpects to file an IND for OV329 and initiate Phase 1 trials in the fourth quarter of 2022. OV329 is a potent GABA aminotransferase inhibitor being studied for the treatment of rare and treatment-resistant forms of epilepsy and seizures, such as tuberous sclerosis complex, infantile spasms and focal seizures.
- Data supporting the preclinical efficacy and safety profile of OV329 are expected to be presented at epilepsy research meetings in the second quarter of 2022.
Ovidintends to present preclinical data on OV329 at the EILAT XVI Conference on New Antiepileptic Drugs and Devicesin May and the Epilepsy Foundation Pipeline Conferencein June. Ovidannounced its focus on the therapeutic area of epilepsy. In March 2022, Ovidreshaped its organizational footprint to align with its focus on epilepsies and direct its resources on its internal candidates for seizures as well as those acquired through business development, such as the library of KCC2 activators it in-licensed last year. As part of the changes, Meg Alexanderwas appointed to a newly created position, Chief Corporate Affairs Officer from her prior role as Head of Communications. The role consolidates and unites Ovid'sengagement strategy across its key stakeholders including community engagement, patient advocacy, investor relations and government affairs.
- The Company announced its financial strategy and expects its cash and cash equivalents to support advancement of its current epilepsy programs into 2025.
Ovidentered into an agreement with Tufts Universityunder the direction of Professor Stephen Moss. Dr. Moss, his lab, and team are recognized leaders in epilepsy research and will support the translation and development of Ovidcandidates, including OV350, Ovid'sdirect KCC2 transporter activator candidate.
- Soticlestat continues to be evaluated by Takeda in two pivotal Phase 3 trials for
Lennox Gastautand Dravet syndromes. Ovidout-licensed soticlestat to Takeda and is eligible to receive regulatory and commercial milestone payments, as well as royalties on global sales of soticlestat, if it is approved and commercialized.
First Quarter 2022 Financial Results
- Cash and cash equivalents as of
March 31, 2022was $166.7 million.
- Revenue for the first quarter ended
March 31, 2022was $1.4 million, as compared to $208.4 millionfor the same period in 2021. Revenue recognized for the first quarter ended March 31, 2022was associated with licensing transactions with Marinus Pharmaceuticals, Inc. and Healx, Ltd.Revenue recognized for the first quarter ended March 31, 2021was associated with licensing transactions with Takeda Pharmaceuticals(Takeda) and Angelini Pharma, Inc.(Angelini Pharma).
- Research and development expenses were
$7.8 millionfor the quarter ended March 31, 2022, as compared to $16.2 millionfor the same period in 2021. The decrease of $8.4 millionwas primarily due to the decision to discontinue the clinical study of OV101 in Angelman syndrome and Fragile X syndrome, and the termination of the Takeda Collaboration Agreement for OV935. The decrease was offset by a payroll and payroll-related expense increase of $1.0 million, which was primarily related to severance pay recognized during the period.
- General and administrative expenses were
$9.9 millionfor the quarter ended March 31, 2022, as compared to $15.6 millionfor the same period. Expenses decreased by $5.7 million. This was primarily due to a $7.2 milliondecrease in legal, professional, and advisory fees that were related to the execution of the Takeda License and Termination Agreement. Partially offsetting these decreases were payroll and payroll-related expenses, which increased by $1.0 million, and were primarily related to severance pay recognized during the period.
- The Company reported net loss of approximately
$16.1 million, or basic and diluted net loss per share attributable to common stockholders of $0.23for the quarter ended March 31, 2022. Net income was $176.0 millionfor the same period in 2021, resulting in basic net income per share of $2.55and diluted net income per share of $2.53. Net income for the three months ended March 31, 2021, was attributable to a one-time upfront payment of $196.0 million(pre-tax) pursuant to the Takeda License and Termination Agreement, and $12.4 millionrecognized in connection with the termination of the license and collaboration agreement with Angelini Pharma.
- Operating expenses were
$17.7 millionfor the quarter ended March 31, 2022, and non-GAAP adjusted operating expenses (which exclude non-recurring expenses and non-cash expenses; see table on Reconciliation of Non-GAAP Expenses) were $14.2 millionfor the quarter. See “Non-GAAP Financial Measures” below for a discussion of non-GAAP adjusted operating expenses.
Non-GAAP Financial Measures
This press release presents non-GAAP adjusted operating expenses on a historical and projected basis. For the period presented, non-GAAP adjusted operating expenses exclude from operating expenses, as calculated and presented in accordance with GAAP, the following non-recurring, non-cash and non-routine items: wind down of OV101 clinical costs; stock-based compensation, and severance fees. Non-GAAP adjusted operating expenses is a financial measure that has not been prepared in accordance with GAAP. Accordingly, investors should consider non-GAAP adjusted operating expenses in addition to, but not as a substitute for, operating expenses that we calculate and present in accordance with GAAP. Among other things, our management uses non-GAAP adjusted operating expenses to establish budgets and operational goals and to manage our business. Other companies may define or use this measure in different ways. We believe that the presentation of non-GAAP adjusted operating expenses provides investors and management with helpful supplemental information relating to operating performance and trends. A table reconciling non-GAAP adjusted operating expenses to operating expenses for all historical periods presented is included below under the heading “Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses.”
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the timing and development of Ovid’s product candidate pipeline and achievement of expected near- and long-term milestones, including the filing of an IND for and anticipated timing of clinical trials of OV329, Ovid’s business development intentions, the ability of Dr. Moss’s team and lab to support the translation and development of
Condensed Consolidated Statements of Operations
|For The Three Months
|For The Three Months
|License and other revenue||$||1,445,366||$||12,382,779|
|License revenue - related party||-||196,000,000|
|Research and development||$||7,832,269||$||16,248,909|
|General and administrative||9,880,203||15,576,554|
|Total operating expenses||17,712,472||31,825,463|
|(Loss) income from operations||(16,267,107||)||176,557,316|
|Other income (expenses), net||209,050||(49,732||)|
|(Loss) income before provision for income taxes||(16,058,056||)||176,507,584|
|Provision for income taxes||50,000||500,277|
|Net (loss) income||$||(16,108,056||)||$||176,007,307|
|Net (loss) income per share, basic||$||(0.23||)||$||2.55|
|Net (loss) income per share, diluted||$||(0.23||)||$||2.53|
|Weighted-average common shares outstanding, basic||70,345,828||66,088,592|
|Weighted-average common shares outstanding, diluted||70,345,828||66,578,377|
Select Condensed Balance Sheet Data
|Cash and cash equivalents||$||166,668,027||$||187,797,532|
|Total stockholder's equity||164,996,271||179,746,436|
|1Working capital defined as current assets less current liabilities|
Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses
|Non-recurring and non-cash items included therein:|
|Wind-down of OV101 clinical costs||243,187||3,750,280|
|Non-GAAP adjusted operating expenses||$||14,166,188||$||26,755,181|
Investors and Media:
Source: Ovid Therapeutics Inc.