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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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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
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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
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268795749 v1
Item 2.02. Results of Operations and Financial Condition.
On May 10, 2022, Ovid Therapeutics Inc. (the “Company”) issued a press release announcing First Quarter 2022 Financial Results and Corporate Highlights. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibit
Exhibit No. |
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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) |
268795749 v1
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.
OVID THERAPEUTICS INC. |
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By: |
/s/ Thomas M. Perone |
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Thomas M. Perone |
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General Counsel & Corporate Secretary |
Dated: May 10, 2022
268795749 v1
Exhibit 99.1
Ovid Therapeutics Reports First Quarter 2022 Financial Results and Corporate Highlights
NEW YORK, May 10, 2022 -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines designed to conquer epilepsies and meaningfully improve the lives of people affected by brain disorders, today reported financial results and corporate highlights for the first quarter ended March 31, 2022.
“Ovid is focused on propelling our pipeline of potential medicines with novel mechanisms of action for epilepsies and seizures,” said Jeremy M. Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid. “We are on track to submit an IND for OV329, a novel GABA aminotransferase inhibitor, for the treatment of epilepsies this year. With our strong balance sheet and experienced team, we believe we have the resources, focus and knowledge to drive our current programs forward and potentially augment them with additional candidates and technologies through business development."
2022 Corporate Highlights & Anticipated Milestones
First Quarter 2022 Financial Results
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.”
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.
Forward-Looking Statements
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 Ovid candidates under the research agreement with Tufts University, the potential therapeutic benefits of Ovid’s current or future product candidates, the continued development of soticlestat by Takeda, the clinical and regulatory development and potential commercialization of soticlestat, OV329, OV350, or any of Ovid’s other current or future product candidates, and Ovid’s expectations regarding its cash runway. You can identify forward-looking statements because they contain words such as “will,” “believes,” “intends,” “anticipates” 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, without limitation, 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, 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 and risks to Ovid’s or any of its partners’ abilities to meet anticipated deadlines and milestones presented by the ongoing COVID-19 pandemic. 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 15, 2022, 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 Operations
Unaudited
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For The Three Months Ended March 31, |
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For The Three Months Ended March 31, |
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2022 |
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2021 |
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Revenue: |
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License and other revenue |
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$ |
1,445,366 |
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$ |
12,382,779 |
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License revenue - related party |
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- |
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196,000,000 |
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Total revenue |
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1,445,366 |
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208,382,779 |
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Operating expenses: |
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Research and development |
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$ |
7,832,269 |
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$ |
16,248,909 |
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General and administrative |
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9,880,203 |
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15,576,554 |
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Total operating expenses |
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17,712,472 |
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31,825,463 |
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(Loss) income from operations |
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(16,267,107 |
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176,557,316 |
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Other income (expenses), net |
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209,050 |
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(49,732 |
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(Loss) income before provision for income taxes |
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(16,058,056 |
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176,507,584 |
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Provision for income taxes |
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50,000 |
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500,277 |
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Net (loss) income |
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$ |
(16,108,056 |
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$ |
176,007,307 |
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Net (loss) income per share, basic |
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$ |
(0.23 |
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$ |
2.55 |
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Net (loss) income per share, diluted |
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$ |
(0.23 |
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$ |
2.53 |
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Weighted-average common shares outstanding, basic |
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70,345,828 |
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66,088,592 |
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Weighted-average common shares outstanding, diluted |
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70,345,828 |
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66,578,377 |
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Select Condensed Balance Sheet Data
Unaudited
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March 31, |
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December 31, |
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2022 |
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2021 |
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Cash and cash equivalents |
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$ |
166,668,027 |
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$ |
187,797,532 |
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Working capital1 |
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159,859,469 |
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175,680,808 |
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Total assets |
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191,096,074 |
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194,544,757 |
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Total stockholder's equity |
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164,996,271 |
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179,746,436 |
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1Working capital defined as current assets less current liabilities |
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Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses
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Three Months Ended March 31, |
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Three Months Ended March 31, |
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2022 |
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2021 |
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Operating expenses |
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$ |
17,712,472 |
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$ |
31,825,463 |
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Non-recurring and non-cash items included therein: |
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Stock-based compensation |
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1,324,812 |
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1,320,002 |
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Severance pay |
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1,978,286 |
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- |
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Wind-down of OV101 clinical costs |
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243,187 |
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3,750,280 |
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Non-GAAP adjusted operating expenses |
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$ |
14,166,188 |
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$ |
26,755,181 |
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Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
917-943-6681
OR
Investors:
Argot Partners
Dawn Schottlandt
212-600-1902