Ovid Therapeutics Reports Third Quarter 2021 Business Update, Corporate Highlights and Financial Results
Ovidis implementing its business development program which intends to secure a series of opportunities that complement and enhance its pipeline of precision and small-molecule CNS medicines
- A development program for soticlestat, which
Ovidlicensed to Takeda, has begun enrolling patients in two pivotal, Phase 3 trials for Lennox-Gastaut and Dravet syndromes
- Company ended the third quarter of 2021 with cash and cash equivalents of
“We have the capital, the expert team and the right strategy in place to unlock value in the rapidly growing field of rare neurology,” said
Ovidconducted a strategic review of approximately 100 potential programs and confirmed desired areas of business development to apply its capital and expertise. As part of this process, neuroscience and biotech experts from Ovid’s Board and Scientific and Clinical Advisory group have been actively involved in evaluating potential technologies and assets.
- The Company will focus on acquiring and in-licensing assets for which it can shape the clinical development trajectory.
Ovidwill seek to create best-in-class or first-in-class medicines that can have a meaningful impact on patients. Business development activities are focused on platform and delivery technologies, in addition to small molecule assets.
- As part of its strategy,
Ovidretained and strengthened its neuroscience talent so that it can rapidly integrate and execute on in-licensed or acquired programs. The Company’s team includes experts in clinical development, medical affairs, research and advocacy, who support Ovid’s potential to be a partner-of-choice in rare neurology. Ovidintends to submit three INDs in three years from its development programs. The Company is targeting an IND submission for OV329, a next-generation GABA aminotransferase inhibitor that is being evaluated in tuberous sclerosis and infantile spasm seizures, in 2022.
- Two pivotal Phase 3 clinical trials evaluating soticlestat for
Lennox Gastautsyndrome and Dravet syndrome are actively enrolling patients. Ovidis eligible to receive regulatory and commercial milestones as well as tiered double-digit royalties, up to 20 percent on global sales of soticlestat, if it is approved and commercialized. Takeda is responsible for funding and operating both trials, and Ovidhas no further financial obligations on soticlestat. If successful, Takeda estimates that it may receive regulatory approval of soticlestat in its fiscal year ending March 2024. Kevin Fitzgerald, Ph.D., an accomplished leader in RNAi therapeutics development, joined the Board of Directors. Dr. Fitzgeraldbrings to Ovidover 20 years of successful drug discovery experience and currently serves as the Chief Scientific Officer, Senior Vice President and Head of Research at Alnylam Pharmaceuticals, where he was instrumental in discovering and clinically validating two forms of siRNA delivery.
Third Quarter 2021 Financial Results
- Cash and cash equivalents as of
September 30, 2021, were $201.8 million.
- Revenue was zero for the quarter ended
September 30, 2021, as compared to $6.9 millionfor the same period in 2020. The revenue in the third quarter of 2020 was due to the recognition of a portion of an upfront payment received from Angelini Pharma.
- Research and development expenses were
$4.9 millionfor the quarter ended September 30, 2021, as compared to $15.9 millionfor the same period in 2020. The decrease of $11 millionwas primarily due to the wind-down of the clinical development of OV101 in Angelman syndrome and Fragile X syndrome and to the termination of Ovid’s responsibilities to fund research and development expenses related to soticlestat’s further development.
- General and administrative expenses were
$6.8 millionfor the quarter ended September 30, 2021, as compared to $7.4 millionthe same period in 2020. The decrease of $0.8 millionwas primarily a result of a decrease in ongoing payroll related expenses.
- Net loss was
$11.4 millionfor the quarter ended September 30, 2021, resulting in basic and diluted net loss per share of $0.17. Net loss was $16.4 millionfor the quarter ended September 30, 2020, resulting in basic and diluted net loss per share attributed to common stockholders of $0.28.
- Operating expenses were
$11.7 millionin the quarter ended September 30, 2021, and non-GAAP adjusted operating expenses (which exclude non-recurring expenses and non-cash expenses) were $9.3 millionfor the third quarter. This expenditure was within the Company’s non-GAAP adjusted guidance of $8.0- $10.0 millionfor the quarter. Ovidexpects non-GAAP adjusted operating expenses to remain within the $8.0- $10.0 millionrange for the fourth quarter of 2021. 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, non-recurring and non-cash items: OV101 clinical costs, severance expense, and stock-based compensation, respectively. 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.” A quantitative reconciliation of projected non-GAAP adjusted operating expenses to operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense and non-recurring expenses.
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with neurological disorders. Ovid seeks to couple deep CNS experience with emerging advances in genetics and the pathways of the brain to build a leading, next-generation neuroscience pipeline. Ovid’s current 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 disorders; and other research targets. Additionally, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Two Phase 3 trials for soticlestat in Dravet syndrome and Lennox-Gastaut syndrome are actively enrolling patients. For more information on Ovid, please visit www.ovidrx.com.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the development and acceleration of Ovid’s product candidate pipeline,
Condensed Consolidated Statements of Operations
|For The Three Months Ended
||For The Three Months Ended
||For The Nine Months Ended
||For The Nine Months Ended
|License and other revenue||$||-||$||6,914,034||$||12,382,779||$||6,914,034|
|License revenue - related party||-||-||196,000,000||-|
|Research and development||$||4,917,393||$||15,875,295||$||28,849,969||$||46,533,610|
|General and administrative||6,764,341||7,442,401||28,970,053||20,220,160|
|Total operating expenses||11,681,734||23,317,696||57,820,022||66,753,770|
|(Loss) income from operations||(11,681,734||)||(16,403,662||)||150,562,757||(59,839,736||)|
|Other income (expenses), net||2,657||(21,127||)||(49,593||)||833,661|
|(Loss) income before (benefit) provision for income taxes||(11,679,077||)||(16,424,789||)||150,513,164||(59,006,075||)|
|(Benefit) provision for income taxes||(294,829||)||-||1,678,532||-|
|Net (loss) income||$||(11,384,248||)||$||(16,424,789||)||$||148,834,632||$||(59,006,075||)|
|Net (loss) income per share, basic||$||(0.17||)||$||(0.28||)||$||2.15||$||(1.04||)|
|Net (loss) income per share, diluted||$||(0.17||)||$||(0.28||)||$||2.14||$||(1.04||)|
|Weighted-average common shares outstanding, basic||67,929,894||59,406,215||67,282,495||56,586,640|
|Weighted-average common shares outstanding, diluted||67,929,894||59,406,215||67,848,033||56,586,640|
Select Condensed Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||201,779,567||$||72,033,930|
|Total stockholder's equity||197,021,761||43,631,656|
1Working capital defined as current assets less current liabilities
Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses
|Non-recurring and non-cash items included therein:|
|Wind-down of OV101 clinical costs||1,105,283|
|Non-GAAP adjusted operating expenses||$||9,307,794|
Investors and Media:
Source: Ovid Therapeutics Inc.