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Ovid Therapeutics Reports Business Updates and Third Quarter 2024 Financial Results

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Ovid Therapeutics reported Q3 2024 financial results and business updates. The company's Phase 1 SAD/MAD study of OV329 is progressing with plans to expand dosing opportunities. A regulatory application for OV350 Phase 1 trial is expected in Q4 2024. The company has paused Phase 2 study of OV888/GV101 to evaluate competitor trial insights. Financial position shows $62.7 million in cash and marketable securities, expected to support operations into H2 2026. Q3 results include revenue of $173,000, R&D expenses of $7.9 million, and a net loss of $14.0 million ($0.20 per share).

Ovid Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. Lo studio di Fase 1 SAD/MAD di OV329 sta proseguendo con piani per espandere le opportunità di dosaggio. Si prevede di presentare una domanda regolatoria per la sperimentazione di Fase 1 di OV350 nel quarto trimestre del 2024. L'azienda ha sospeso lo studio di Fase 2 di OV888/GV101 per valutare le intuizioni della sperimentazione dei concorrenti. La posizione finanziaria mostra 62,7 milioni di dollari in contante e titoli negoziabili, previsti per supportare le operazioni fino alla seconda metà del 2026. I risultati del terzo trimestre includono ricavi di 173.000 dollari, spese per R&S di 7,9 milioni di dollari e una perdita netta di 14,0 milioni di dollari (0,20 dollari per azione).

Ovid Therapeutics reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones empresariales. El estudio de Fase 1 SAD/MAD de OV329 está avanzando con planes de expandir las oportunidades de dosificación. Se espera una solicitud regulatoria para el ensayo de Fase 1 de OV350 en el cuarto trimestre de 2024. La empresa ha pausado el estudio de Fase 2 de OV888/GV101 para evaluar las perspectivas de los ensayos de los competidores. La posición financiera muestra 62,7 millones de dólares en efectivo y valores negociables, que se espera que sustenten las operaciones hasta la segunda mitad de 2026. Los resultados del tercer trimestre incluyen ingresos de 173.000 dólares, gastos en I+D de 7,9 millones de dólares y una pérdida neta de 14,0 millones de dólares (0,20 dólares por acción).

Ovid Therapeutics는 2024년 3분기 재무 결과와 사업 업데이트를 발표했습니다. OV329의 1상 SAD/MAD 연구는 진행 중이며 용량 기회 확장을 계획하고 있습니다. OV350 1상 시험을 위한 규제 신청이 2024년 4분기에 기대됩니다. 이 회사는 경쟁자의 시험 통찰을 평가하기 위해 OV888/GV101의 2상 연구를 일시 중단했습니다. 재무 상태는 6,270만 달러의 현금 및 유가증권을 보여주며, 이는 2026년 하반기까지 운영을 지원할 것으로 예상됩니다. 3분기 결과에는 173,000달러의 수익, 790만 달러의 연구개발비, 그리고 1주당 0.20달러의 순손실 1,400만 달러가 포함됩니다.

Ovid Therapeutics a communiqué ses résultats financiers pour le troisième trimestre 2024 et des mises à jour sur ses activités. L'étude de Phase 1 SAD/MAD de OV329 avance, avec des plans pour élargir les possibilités de dosage. Une demande réglementaire pour l'essai de Phase 1 de OV350 est prévue pour le quatrième trimestre 2024. L'entreprise a suspendu l'étude de Phase 2 de OV888/GV101 afin d'évaluer les insights des essais de ses concurrents. La position financière indique 62,7 millions de dollars en liquidités et titres négociables, qui devraient soutenir les opérations jusqu'à la deuxième moitié de 2026. Les résultats du troisième trimestre comprennent des revenus de 173 000 dollars, des frais de recherche et développement de 7,9 millions de dollars et une perte nette de 14,0 millions de dollars (0,20 dollars par action).

Ovid Therapeutics hat die finanziellen Ergebnisse für das 3. Quartal 2024 und Geschäftsupdates bekannt gegeben. Die Phase-1-SAD/MAD-Studie von OV329 schreitet voran, und es sind Pläne zur Erweiterung der Dosierungsmöglichkeiten in Arbeit. Ein regulatorischer Antrag für die Phase-1-Studie von OV350 wird im 4. Quartal 2024 erwartet. Das Unternehmen hat die Phase-2-Studie von OV888/GV101 ausgesetzt, um Wettbewerber-Studienerkenntnisse zu bewerten. Die finanzielle Lage zeigt 62,7 Millionen Dollar in Bar- und marktgängigen Wertpapieren, die voraussichtlich die Betriebstätigkeiten bis in die zweite Hälfte von 2026 unterstützen werden. Die Ergebnisse des 3. Quartals umfassen Einnahmen von 173.000 Dollar, F&E-Ausgaben von 7,9 Millionen Dollar und einen Nettoverlust von 14,0 Millionen Dollar (0,20 Dollar pro Aktie).

Positive
  • Cash position of $62.7M expected to fund operations into H2 2026
  • Encouraging safety data from OV329 Phase 1 study
  • Revenue increased to $173,000 from $109,000 in Q3 2023
Negative
  • Net loss increased to $14.0M from $11.3M in Q3 2023
  • R&D expenses increased to $7.9M from $5.3M year-over-year
  • Phase 2 study of OV888/GV101 paused due to competitive landscape concerns

Insights

The Q3 results reveal concerning financial metrics with a widening net loss of $14.0 million ($0.20 per share) compared to $11.3 million in Q3 2023. Operating expenses increased to $13.4 million, primarily driven by higher R&D costs of $7.9 million. The cash position of $62.7 million provides runway into H2 2026, but with increased spending and minimal revenue ($173,000), careful cash management will be crucial.

The pause in OV888/GV101's Phase 2 trial and strategic pipeline reprioritization reflects prudent capital allocation but may delay potential value creation. The focus on OV329 and KCC2 programs represents a more concentrated risk profile. Cost control measures, including reduced G&A expenses, demonstrate fiscal discipline but may not offset rising R&D costs.

The development pipeline shows mixed signals. While OV329's Phase 1 safety data appears encouraging enough to warrant exploring additional dosing cohorts, the pause in OV888/GV101's CCM program following competitor trial results raises concerns about the program's future. The rapid tissue clearance and improved ocular safety profile of OV329 versus vigabatrin represents a potential competitive advantage.

The advancement of OV350 as the first KCC2 direct activator into clinical development by Q1 2025 marks a significant milestone. The compound's demonstrated anti-psychotic and anticonvulsant effects in preclinical studies suggest broad therapeutic potential. However, investors should note that success in preclinical models doesn't guarantee clinical efficacy.

  • A Phase 1 SAD/MAD study of OV329 is progressing as planned, and based on encouraging human safety data to date, Ovid will engage regulators about adding cohorts to increase potential dosing opportunities for Phase 2 programs.
  • A regulatory application for a Phase 1 trial of OV350, the first candidate from Ovid's KCC2 direct activator library, is expected to be filed in Q4 2024.
  • The Company will host a KCC2 Download Day on November 13 to provide updates on Ovid's platform of KCC2 direct activators and their broad therapeutic potential.
  • Ovid and Graviton are pausing the initiation of a Phase 2 study of OV888/GV101 to evaluate emerging insights from two recently completed competitor trials in cerebral cavernous malformations.
  • Cash and marketable securities of $62.7 million as of September 30, 2024, is expected to support operations and development programs into H2 2026.

NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing medicines for brain conditions with significant unmet need, today reported business updates and financial results for the third quarter ended September 30, 2024.

"The biopharmaceutical industry is entering an exciting new era of neurotherapeutics, and we are poised to address significant unmet needs in diseases of the central nervous system. Our innovative programs featuring differentiated mechanisms of action, such as GABA-aminotransferase inhibition, KCC2 direct activation, and ROCK2 inhibition, offer powerful approaches to address fundamental biological causes of neurological and neuropsychiatric conditions and symptoms," said Dr. Jeremy Levin, D.Phil., MB BChir., Chairman and CEO of Ovid Therapeutics. "With a clear and disciplined capital strategy, we're channeling our resources toward programs that we believe have the greatest potential to deliver meaningful clinical outcomes and pivotal milestones within our financial runway. This includes the proactive decision to pause the initiation of the Phase 2 program in CCM to incorporate fresh insights from recent competitor trials in an effort to strengthen the approach for this community."

General Corporate & Business Updates

  • Pipeline strategy and focus: Ovid is advancing its pipeline in a fiscally disciplined and clinically and scientifically rigorous fashion in an effort to achieve its vision of becoming a leader in neurotherapeutics for brain disorders with significant unmet need. Central to the Company's strategy is identifying and developing differentiated mechanisms of action to interdict unaddressed biological targets in the brain that are fundamental to disease pathology. This strategy includes achieving a potential best-in-class next generation GABA aminotransferase inhibitor, (GABA-AT) translating the direct activation of the potassium chloride co-transporter 2 (KCC2) for a broad range of central nervous system (CNS) conditions, and pioneering Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibition for neurovascular and neuro-inflammatory conditions.
  • Capital allocation and business development strategy: Over the last quarter, Ovid has streamlined its operations, prioritized its pipeline programs and aligned its financial strategy to support the potential achievement of key value-creating clinical milestones. This includes a focus on advancing the development of OV329 and Ovid's library of KCC2 direct activators. Ovid expects its cash runway to support operations and clinical development into H2 2026. During this period, Ovid plans to achieve multiple clinical and regulatory milestones associated with its OV329 and OV350 programs, and to advance undisclosed ROCK2 inhibition programs with its collaborator, Graviton Bioscience. Ovid will continue to explore partnerships and co-development opportunities for select programs to accelerate development and offset costs.
  • Strengthened leadership team: In the third quarter of 2024, Ovid strengthened its leadership team in capabilities central to the execution of its corporate strategy and vision. This included the promotion of Meg Alexander to President and Chief Operating Officer and the hiring of Dr. Amanda Banks to serve as Chief Development Officer. Collectively, the executive team will focus on the progression of Ovid's pipeline as well as corporate and business development.

OV329

  • A next-generation GABA aminotransferase inhibitor: Ovid is developing OV329 as a next-generation GABA-AT inhibitor that seeks to reduce neuronal hyperexcitability with less sedation and without ocular changes that are associated with an older drug in the class, vigabatrin. Ovid's preclinical characterization suggests that OV329 is more potent, delivers synaptic and extra-synaptic inhibition, and has a lasting pharmacodynamic effect with rapid tissue clearance.
  • Phase 1: Ovid is executing, as planned, a Phase 1 multiple ascending dose (MAD) study evaluating OV329. Based upon supportive human safety data to date, Ovid plans to explore with regulators adding cohorts to increase dosing opportunities for future Phase 2 programs. Topline data are anticipated in 2025, and Ovid will provide more detailed timelines following discussions with regulators. The Company anticipates sharing results on safety, tolerability, and two biomarkers that may provide a signal for target engagement and clinical effect, using magnetic resonance spectrometry and transcranial magnetic spectroscopy, respectively.
    • Ocular safety characterization: To evaluate OV329's safety compared to vigabatrin, Ovid has conducted additional animal experiments to evaluate the risk of drug accumulating in the eye and causing retinal cell dysregulation. At the Epilepsy Pipeline Conference in September 2024, Ovid presented results from an animal study demonstrating that OV329 did not accumulate in animal eyes in contrast with vigabatrin. OV329 was present in the brain plasma of mice and then rapidly cleared the tissue and remained undetectable in the retina, eye, and brain. In contrast, vigabatrin was demonstrated to accumulate in the eye, retina and brain, which is consistent with previously published independent research. The full results from this head-to-head study will be presented at the 2024 American Epilepsy Society conference in December.

OV350 and KCC2 library

  • OV350 Phase 1, first-in-human study for a KCC2 direct activator: Ovid expects to submit a regulatory application for a Phase 1 trial of OV350 before year end 2024, and to initiate the first-in-human study for this class of molecule in Q1 2025. OV350 is the first of multiple anticipated programs from Ovid's library of KCC2 direct activators. The Phase 1 trial intends to evaluate the safety, tolerability and pharmacokinetic parameters of an IV formulation of OV350 in healthy human volunteers. In preclinical and animal disease models, OV350 has demonstrated anti-psychotic and anticonvulsant effects, indicating it may have broad therapeutic utility.
  • KCC2 direct activator library: Ovid is also progressing its KCC2 library, which comprises multiple compounds with different pharmacology and combinations of effects across neurological conditions with high unmet need, including: neuropsychiatric, neurodevelopmental and neurodegenerative applications. These compounds have unique therapeutic characteristics and are amenable for oral and intramuscular formulations to address indications across the care continuum.
  • KCC2 Download Day: Ovid will be hosting a session on November 13, 2024, from 9:30-11:30 AM, Eastern time, focused on the therapeutic potential of its portfolio of KCC2 direct activators, a target fundamental to restoring neuronal homeostasis. Ovid management and recognized thought leaders will present. A live webcast of the presentation can be accessed through the Events and Presentations section of Ovid's website at https://investors.ovidrx.com.

OV888/GV101 & ROCK2 inhibitor programs

  • OV888/GV101 Capsule for CCM: Following the recent completion of long-duration competitor trials in CCM, and after discussions with key stakeholders, Ovid and Graviton Bioscience have decided to pause the initiation of the Phase 2 proof-of-concept study of OV888/GV101 capsule in CCM. Ovid and Graviton Bioscience received regulatory clearance to initiate a Phase 2 program in Israel and were in the process of applying for clearance in other regions, but they will take a strategic pause to evaluate clinical design learnings emerging from competitor Phase 2 programs. The companies are confident in the potential therapeutic effects of ROCK2 inhibition for CCM and will seek to optimize future development approaches with the benefit of further insights on study duration, enrichment strategies, endpoints, and time-to-event measurements.
  • ROCK2 inhibition programs: Ovid and Graviton continue to pursue additional formulations of OV888/ GV101 for undisclosed cerebral vascular conditions with high unmet need.

Third Quarter 2024 Financial Results

  • Cash, cash equivalents and marketable securities as of September 30, 2024, totaled $62.7 million.
  • Revenues from royalty agreements were $173,000 for the third quarter ended September 30, 2024, as compared to $109,000 in the same period in 2023.
  • Research and development expenses were $7.9 million for the third quarter ended September 30, 2024, compared to $5.3 million in the same period in 2023. The increase is related to the advancement of Ovid's clinical and preclinical pipeline programs as described above.
  • General and administrative expenses were $5.5 million for the third quarter ended September 30, 2024, as compared to $6.8 million for the same period in 2023. The decrease was driven by the previous organizational restructuring and related cost-reduction efforts.
  • Total operating expenses were $13.4 million for the third quarter ended September 30, 2024, as compared to $12.1 million for the same period last year.
  • Ovid reported a net loss of $14.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.20, for the third quarter of 2024, as compared to a net loss of $11.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.16, for the same period in 2023.

About Ovid Therapeutics

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing medicines for brain conditions with significant unmet need. 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 multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-AT inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; OV350, and a library of compounds that directly activate the KCC2 co-transporter, for multiple CNS disorders; and OV888/GV101, a highly selective ROCK2 inhibitor for undisclosed neurovascular and neuro-inflammatory 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 expected timing of initiation, completion, and results and data of Ovid’s clinical studies; the potential to add cohorts to the Phase 1 SAD/MAD study of OV329, expected timing of completion of the study and expected timing of data presentation; the expected timing of submission of a regulatory application for a Phase 1 trial of OV350 IV and the expected timing of initiation of the trial; Ovid’s evaluation of the results of two recently completed competitor trials to OV888/GV101 for CCM; Ovid’s ability to achieve expected benefits of cost-savings efforts; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid's operations and development programs; the potential use and development of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; the potential therapeutic opportunity of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; 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 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 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.


 
Condensed Consolidated Statements of Operations
Unaudited
 
(in thousands, except share and per share data)For The Three Months Ended
September 30, 2024
 For The Three Months Ended
September 30, 2023
Revenue:   
License and other revenue$173  $109 
Total revenue 173   109 
Operating expenses:   
Research and development 7,855   5,333 
General and administrative 5,544   6,805 
Total operating expenses 13,399   12,138 
Loss from operations (13,226)  (12,029)
Other income (expense), net (780)  776 
Loss before provision for income taxes (14,006)  (11,253)
Provision for income taxes     
Net loss$(14,006) $(11,253)
Net loss per share, basic$(0.20) $(0.16)
Net loss per share, diluted$(0.20) $(0.16)
Weighted-average common shares outstanding, basic 70,975,778   70,618,609 
Weighted-average common shares outstanding, diluted 70,975,778   70,618,609 


Select Condensed Consolidated Balance Sheet Data
Unaudited
 
(in thousands)September 30, 2024 December 31, 2023
Cash, cash equivalents and marketable securities$62,712  $105,834 
Working capital(1) 54,197   98,125 
Total assets 102,654   144,027 
Total stockholders’ equity 76,290   87,797 
(1)Working capital defined as current assets less current liabilities


Contacts

Investor Relations
Garret Bonney
IR@ovidrx.com

Media
Raquel Cabo
RCabo@ovidrx.com


FAQ

What was Ovid Therapeutics (OVID) Q3 2024 net loss per share?

Ovid Therapeutics reported a net loss of $0.20 per share for Q3 2024, compared to $0.16 per share in Q3 2023.

How much cash does Ovid Therapeutics (OVID) have as of Q3 2024?

Ovid Therapeutics had $62.7 million in cash and marketable securities as of September 30, 2024.

When will Ovid Therapeutics (OVID) file the regulatory application for OV350?

Ovid Therapeutics expects to file the regulatory application for OV350's Phase 1 trial in Q4 2024.

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