# EDGAR Filing Document

**Accession Number:** 0001636651
**File Stem:** 0001628280-25-040007
**Filing Date:** 2025-8
**Character Count:** 24817
**Document Hash:** 220761d60a09b2ba5bbbde12674095bb
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-25-040007.hdr.sgml**: 20250813

**ACCESSION NUMBER**: 0001628280-25-040007

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250813

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250813

**DATE AS OF CHANGE**: 20250813

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Ovid Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0001636651
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 465270895
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38085
- **FILM NUMBER:** 251209049

**BUSINESS ADDRESS:**
- **STREET 1:** 441 NINTH AVENUE, 14TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10001
- **BUSINESS PHONE:** 212-776-4381

**MAIL ADDRESS:**
- **STREET 1:** 441 NINTH AVENUE, 14TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10001

?xml version='1.0' encoding='ASCII'? ovid-20250813

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** August 12, 2025

**OVID THERAPEUTICS INC.**

 **(Exact name of Registrant as Specified in Its Charter)** 

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| | | |
|:---|:---|:---|
| **Delaware** | **001-38085** | **46-5270895** |
| **(State or Other Jurisdiction**<br>**of Incorporation)** | **(Commission File Number)** | **(IRS Employer**<br>**Identification No.)** |
| **441 Ninth Avenue, 14th Floor**<br>**New York, New York** | | **10001** |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

---

**Registrant's Telephone Number, Including Area Code: 646-661-7661**

**Not Applicable**

**(Former Name or Former Address, if Changed Since Last Report)**

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):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br>**Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.001 per share | OVID | The Nasdaq Stock Market LLC |

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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 ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

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**Item 2.02.Results of Operations and Financial Condition.**

On August 13, 2025, Ovid Therapeutics Inc. (the "Company") issued a press release announcing business updates and second quarter 2025 financial results. 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 3.01.&nbsp;&nbsp;&nbsp;&nbsp;Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.**

As previously disclosed on a Current Report on Form 8-K filed by the Company on February 13, 2025, the Company received a letter from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on February 10, 2025 notifying the Company that the average closing bid price of the Company's shares of common stock was below the minimum closing bid price of $1.00 per share during the last 31 consecutive trading days, as required for continued listing on the Nasdaq under Rule 5450(a)(1) of the Nasdaq's Listing Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, or until August 11, 2025, to regain compliance with the minimum bid price requirement. As of the date of this Current Report on Form 8-K, the Company's common stock has not regained compliance with the minimum bid price requirement.

However, the Company was notified by the Staff in a letter dated August 12, 2025, that the Company's application to transfer to the Nasdaq Capital Market was approved and the Company is eligible for an additional 180 calendar day period, or until February 9, 2026 (the "Second Compliance Date"), to regain compliance with the minimum bid price requirement. At the opening of business on August 14, 2025, the Company's common stock will be transferred to the Nasdaq Capital Market, which operates in substantially the same manner as the Nasdaq Global Select Market, where it continues to trade under the symbol "OVID."

The Company intends to monitor the closing bid price for its securities and explore available options to regain compliance within the proscribed time period, including by effecting a reverse stock split, if necessary.

In the event the Company fails to regain compliance before the Second Compliance Date, the Company will receive a written notification from Nasdaq that is common stock is subject to delisting. If the Company were to receive such a notification, the Company could appeal Nasdaq's determination to delist its common stock to a Nasdaq Hearings Panel (the "Panel"). There can be no assurance that any such appeal would be successful or that the Company would be able to evidence compliance with the terms of any extension that may be granted by the Panel. Furthermore, there can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq Listing Rules.

**Item 9.01.Financial Statements and Exhibits.**

(d) Exhibit

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press Release, dated](ovid2025q2exhibit991.htm)</u> August 13, 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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**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.

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| | |
|:---|:---|
| **OVID THERAPEUTICS INC.** | **OVID THERAPEUTICS INC.** |
| By: | /s/ Jeffrey Rona |
|  | Jeffrey Rona |
|  | Chief Business and Financial Officer<br>*(Principal Financial and Accounting Officer)* |

---

Dated: August 13, 2025

## Exhibit 99.1

Exhibit 99.1

![ovid-therapeutics_logo750s.jpg](ovid-therapeutics_logo750s.jpg)

**Ovid Therapeutics Reports Business Updates and Second Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Topline results from the OV329 Phase 1 safety, tolerability and biomarker study remain on track for a readout in Q3 2025

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• $7.0 million royalty monetization agreement signed with Immedica Pharma AB for future ganaxolone royalties, delivering capital to the Company from a non-pipeline asset

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• OV4071, the first ever oral KCC2 direct activator, is completing an IND-enabling package; Ovid anticipates first-in-human studies in Q2 2026

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Cash, cash equivalents and marketable securities of $38.3 million as of June 30, 2025 are expected to support currently planned operations and development programs into early 2H 2026

NEW YORK, August 13, 2025 -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today reported business updates and financial results for the second quarter ended June 30, 2025.

"Our pipeline continues to advance across multiple fronts, with several key readouts anticipated in the near and mid-term. We are on track to share Phase 1 safety, tolerability, and biomarker data for OV329, a potential best-in-class medicine for conditions driven by excess neuronal excitation, including treatment-resistant seizures and pain," said Dr. Jeremy Levin, D.Phil., MB BChir., Chairman and CEO of Ovid Therapeutics. "Simultaneously, our KCC2 program is advancing well. We expect to read out safety and tolerability data for OV350, our first-in-human KCC2 direct activator, before the end of the year, setting the stage for our broader pipeline of oral KCC2 direct activators. We are also completing IND-enabling work for OV4071 and plan to initiate a Phase 1/1b healthy volunteer and patient study in early 2026. Collectively, these milestones may provide compelling de-risking evidence for drugging and directly activating a new target in the brain with substantial therapeutic opportunity."

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***KEY PIPELINE AND BUSINESS UPDATES***

**OV329: Phase 1 Topline Readout Planned for Q3 2025**

OV329, a next-generation GABA-aminotransferase (GABA-AT) inhibitor, is progressing through a Phase 1 clinical trial in healthy volunteers. Topline results, including pharmacodynamic (PD), safety, and exploratory target engagement data, are anticipated in late Q3 2025.

OV329 is rationally designed to be a safer, well tolerated inhibitor of GABA-AT, a validated mechanism of action for reducing neuronal excitation and thereby, seizures. It has been shown to endogenously increase levels of GABA, the major inhibitory neurotransmitter, in the brain. OV329 is intended to replace vigabatrin, a first-generation GABA-AT inhibitor that is associated with serious safety concerns, including irreversible ocular changes and blindness in some patients, which limits its clinical use.

OV329 is significantly more potent than vigabatrin and, in preclinical studies, demonstrated synaptic and extrasynaptic inhibition, along with anti-convulsant activity in nine different animal seizure models. At projected therapeutic doses, OV329 has demonstrated a potentially favorable therapeutic index and did not induce sedation. OV329 is being developed for the possible treatment of drug-resistant epilepsies (DREs), with broader potential across a range of indications in which neuronal hyperexcitation is implicated.

**OV329: Clinical Development**

Across previously completed cohorts, OV329 has been well tolerated, with no serious adverse events observed to date. The Company believes this emerging profile supports OV329's potential as a novel treatment that leverages a validated mechanism of action (MOA), while addressing the safety limitations that have historically constrained broader clinical use of the first-generation GABA-AT inhibitor.

The Phase 1 study in healthy volunteers is designed with a highly rational biomarker-driven clinical development strategy that incorporates cutting-edge tools to evaluate central GABAergic activity. Several exploratory biomarkers are being used to assess OV329's intended pharmacodynamic effects. These biomarkers include transcranial magnetic stimulation (TMS) to assess cortical inhibition, magnetic resonance spectroscopy (MRS) to measure GABA levels in the medial parietal lobe, and quantitative electroencephalography (EEG) to evaluate brainwave patterns. TMS has previously been studied in healthy volunteers treated with the first-generation GABA-AT inhibitor vigabatrin, providing a partially validated and clinically relevant comparator to help interpret OV329's intended CNS effects. Together, these translational biomarkers offer early insights into pharmacodynamic effects and strengthen the foundation for a rational and differentiated anti-seizure development program.

Pending the results of the Phase 1 study, Ovid plans to initiate a Phase 2a trial in adults with treatment-resistant focal onset seizures. The development approach is intended to preserve flexibility to explore additional forms of DRE and select developmental and epileptic encephalopathies (DEEs) in both adult and pediatric populations.

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**Progressing a First-in-Class Portfolio of Oral KCC2 Direct Activators Toward the Clinic**

The Company is making significant progress on its portfolio of first-in-class direct activators for the potassium-chloride cotransporter 2 (KCC2). KCC2 is a neuron-specific chloride transporter that plays a central role in regulating neuronal excitability and enabling GABA to exert its inhibitory effect. Ovid's portfolio includes multiple unique molecules that have been shown to bind to and directly activate KCC2, reflecting a potentially differentiated, mechanism-based approach to addressing serious neurological and neuropsychiatric brain conditions. Direct activation is also believed to contribute to a preferable safety profile.

**OV350 (Intravenous KCC2 Direct Activator):** The Company is actively studying the first-ever KCC2 direct activator in healthy volunteers. The safety, tolerability and pharmacokinetic data for OV350 are anticipated to be available in Q4 2025. This milestone is designed to establish safety of this new class of potential medicines - direct activators of KCC2. Findings from this program are helping to guide Ovid's development of its oral KCC2 candidates.

**OV4071 (Oral KCC2 Direct Activator):** IND-enabling activities are underway for OV4071, the Company's first oral KCC2 development candidate. The Company remains on track to initiate a proof-of-concept clinical study early in 2026. OV4071 is initially being developed for the treatment of psychosis, including in Parkinson's disease and Lewy body dementia—areas with substantial unmet need and a defined regulatory pathway.

**Broader Oral KCC2 Portfolio:** In addition to OV4071, the Company is advancing multiple oral and injectable KCC2 activator programs selected from its proprietary library.

Direct activation of KCC2 may be a promising new therapeutic approach to restore inhibitory tone in the brain and has potential utility across a broad range of disorders characterized by neuronal hyperexcitability.

**Monetization of Ganaxolone Royalties Provides Strategic Capital**

In June 2025, Ovid entered into an agreement with Immedica Pharma AB to sell its worldwide ganaxolone royalty rights and licensing for $7.0 million. This monetization covers 100% of royalty rights and includes the transfer or licensing of Ovid's global ganaxolone intellectual property, with Immedica assuming associated patent maintenance and prosecution costs.

This capital transaction strengthens Ovid's balance sheet, extends its operational runway, and enables the Company to focus capital and strategic efforts on its wholly owned small molecule pipeline. Ovid has not been pursuing active development of ganaxolone, and the transaction has no impact on its current pipeline programs.

***BUSINESS STRATEGY AND UPDATES***

Ovid expects its cash runway to support operations and clinical development programs into early second half 2026, during which time multiple pipeline and regulatory milestones are anticipated. These anticipated milestones include topline results for OV329 safety, tolerability and biomarker data (Q3 2025); potential initiation of a Phase 2a patient study for OV329 in drug-resistant epilepsies (Q1 2026); results from the Phase 1 study of OV350 (Q4 2025); and the potential initiation of a proof-of-concept trial for the first oral KCC2 direct activator, OV4071 (Q2 2026).

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Given the breadth and depth of its pipeline, and the broad therapeutic opportunity it may yield, the Company will continue to explore a range of strategic options to accelerate development and offset costs, such as partnerships, co-development and regional opportunities for select programs, as well as monetizing equity positions, intellectual property and non-CNS applications of its candidates. The Company will continue to manage its clinical development programs, operations and cash expenditures with fiscal discipline to support the potential achievement of key value-creating clinical milestones.

**Second Quarter 2025 Financial Results**

• Cash, cash equivalents and marketable securities as of June 30, 2025 totaled $38.3 million.

• Revenues from royalty agreements were $6.3 million for the second quarter ended June 30, 2025, as compared to $169,000 for the same period in 2024.

• Research and development expenses were $6.5 million for the second quarter ended June 30, 2025, compared to $12.6 million for the same period in 2024. The decrease is related to the organizational restructuring in Q2 2024 to re-prioritize Ovid's clinical and preclinical pipeline programs.

• General and administrative expenses were $4.9 million for the second quarter ended June 30, 2025, as compared to $8.1 million for the same period in 2024. The decrease was driven by the organizational restructuring and related cost-reduction efforts.

• Total operating expenses were $11.3 million for the second quarter ended June 30, 2025, as compared to $20.7 million for the same period in 2024.

• Ovid reported a net loss of $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.06, for the second quarter of 2025, as compared to a net income of $8.5 million, or basic and diluted net income per share attributable to common stockholders of $0.12, for the same period in 2024.

**About Ovid Therapeutics**

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications and; OV350, OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders. 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 expected timing of initiation, completion, and results and data of Ovid's clinical studies; Ovid's expectations regarding the duration of its cash runway and the expectation that it will support Ovid's operations and development programs; the

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potential use and development of OV329, OV350, OV4071 and other compounds from Ovid's library of direct activators of KCC2; the potential therapeutic opportunity of OV329, OV350, OV4071 and other compounds from Ovid's library of direct activators of KCC2; the expected timing of initiation of a proof-of-concept trial for OV4071 and the submission to initiate clinical development; Ovid's clinical pipeline strategy and plans for future clinical studies; the expected timing of IND-enabling and formulation efforts for molecules from its KCC2 direct activator library and related regulatory submissions; Ovid's potential future business development opportunities; 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, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid's ability to achieve expected benefits of cost-savings efforts, 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 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 or unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions. 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 most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission ("SEC"), and in subsequent and 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.

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**Condensed Consolidated Statements of Operations**

Unaudited

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| | | |
|:---|:---|:---|
| (in thousands, except share and per share data) | **For The Three Months Ended<br>June 30, 2025** | **For The Three Months Ended<br>June 30, 2024** |
| Revenue: |  |  |
| &nbsp;&nbsp;License and other revenue | $6272 | $169 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenue | 6272 | 169 |
| Operating expenses: |  |  |
| &nbsp;&nbsp;Research and development | 6465 | 12582 |
| &nbsp;&nbsp;General and administrative | 4880 | 8104 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 11345 | 20686 |
| Loss from operations | (5073) | (20517) |
| Other income (expense), net | 389 | 29038 |
| (Loss) income before provision for income taxes | (4684) | 8521 |
| Provision for income taxes |  |  |
| Net (loss) income | $(4684) | $8521 |
| Net (loss) income per share of Series A preferred stock, basic | $(64.73) | $118.07 |
| Net (loss) income per share of Series A preferred stock, diluted | $(64.73) | $117.61 |
| Weighted-average Series A preferred stock shares outstanding, basic and diluted | 1250 | 1250 |
| Net (loss) income per share of common stock, basic | $(0.06) | $0.12 |
| Net (loss) income per share of common stock, diluted | $(0.06) | $0.12 |
| Weighted-average common stock shares outstanding, basic | 71109514 | 70916471 |
| Weighted-average common stock shares outstanding, diluted | 71109514 | 71200798 |

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**Select Condensed Consolidated Balance Sheet Data**

Unaudited

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| | | |
|:---|:---|:---|
| (in thousands) | **June 30, 2025** | **December 31, 2024** |
| Cash, cash equivalents and marketable securities | $38347 | $53075 |
| Working capital<sup>(1)</sup> | 33165 | 45418 |
| Total assets | 77428 | 92167 |
| Total stockholders' equity | 55789 | 68226 |
| <sup>(1)</sup>Working capital defined as current assets less current liabilities | <sup>(1)</sup>Working capital defined as current assets less current liabilities | <sup>(1)</sup>Working capital defined as current assets less current liabilities |

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**Contact**

**Investor Relations & Media**

Victoria Fort

VFort@ovidrx.com

<br>