STOCK TITAN

Outlook Therapeutics® Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags

Outlook Therapeutics (OTLK) announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. The company's CFO and Interim CEO, Lawrence A. Kenyon, presented the top five reasons why investors should focus on Outlook Therapeutics in 2025. The presentation is now available for viewing online.

Notably, OTLK is a biopharmaceutical company that has achieved regulatory approval in the European Union and the United Kingdom for its ophthalmic formulation of bevacizumab, marking the first authorized use of such treatment for wet age-related macular degeneration (wet AMD).

Outlook Therapeutics (OTLK) ha annunciato la sua partecipazione alla Conferenza Virtual Investor 'Top 5 for '25' On-Demand. Il CFO e CEO ad interim dell'azienda, Lawrence A. Kenyon, ha presentato i cinque motivi principali per cui gli investitori dovrebbero concentrarsi su Outlook Therapeutics nel 2025. La presentazione è ora disponibile per la visione online.

È importante notare che OTLK è un'azienda biofarmaceutica che ha ottenuto l'approvazione normativa nell'Unione Europea e nel Regno Unito per la sua formulazione oftalmica di bevacizumab, segnando il primo uso autorizzato di tale trattamento per la degenerazione maculare legata all'età umida (wet AMD).

Outlook Therapeutics (OTLK) anunció su participación en la Conferencia Virtual Investor 'Top 5 for '25' On-Demand. El CFO y CEO interino de la compañía, Lawrence A. Kenyon, presentó las cinco principales razones por las que los inversores deberían centrarse en Outlook Therapeutics en 2025. La presentación ya está disponible para su visualización en línea.

Es notable que OTLK es una empresa biofarmacéutica que ha logrado la aprobación regulatoria en la Unión Europea y el Reino Unido para su formulación oftálmica de bevacizumab, marcando el primer uso autorizado de dicho tratamiento para la degeneración macular relacionada con la edad húmeda (wet AMD).

Outlook Therapeutics (OTLK)는 가상 투자자 'Top 5 for '25' 온디맨드 컨퍼런스에 참여한다고 발표했습니다. 회사의 CFO이자 임시 CEO인 Lawrence A. Kenyon은 투자자들이 2025년에 Outlook Therapeutics에 주목해야 하는 다섯 가지 주요 이유를 제시했습니다. 발표는 이제 온라인에서 시청할 수 있습니다.

특히 OTLK는 유럽 연합영국에서 습성 노인성 황반변성(wet AMD)에 대한 최초의 승인된 치료법으로서의 베바시주맙 안과 제형에 대한 규제 승인을 획득한 바이오 제약 회사입니다.

Outlook Therapeutics (OTLK) a annoncé sa participation à la conférence virtuelle 'Top 5 for '25' On-Demand pour les investisseurs. Le CFO et PDG par intérim de l'entreprise, Lawrence A. Kenyon, a présenté les cinq principales raisons pour lesquelles les investisseurs devraient se concentrer sur Outlook Therapeutics en 2025. La présentation est désormais disponible en ligne.

Il est à noter qu'OTLK est une entreprise biopharmaceutique qui a obtenu l'approbation réglementaire dans l'Union Européenne et au Royaume-Uni pour sa formulation ophtalmique de bevacizumab, marquant la première utilisation autorisée de ce traitement pour la dégénérescence maculaire liée à l'âge humide (wet AMD).

Outlook Therapeutics (OTLK) gab seine Teilnahme an der virtuellen Investorenkonferenz 'Top 5 for '25' On-Demand bekannt. Der CFO und interimistische CEO des Unternehmens, Lawrence A. Kenyon, stellte die fünf Hauptgründe vor, warum Investoren 2025 auf Outlook Therapeutics achten sollten. Die Präsentation ist jetzt online verfügbar.

Bemerkenswert ist, dass OTLK ein biopharmazeutisches Unternehmen ist, das in der Europäischen Union und im Vereinigten Königreich die behördliche Genehmigung für seine ophthalmologische Formulierung von Bevacizumab erhalten hat, was die erste genehmigte Anwendung dieser Behandlung für die feuchte altersbedingte Makuladegeneration (wet AMD) markiert.

Positive
  • Secured regulatory approval in EU and UK for ophthalmic bevacizumab for wet AMD treatment
  • First authorized ophthalmic bevacizumab formulation in these markets
Negative
  • None.

On-demand video webcast now available here

ISELIN, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it participated in the Virtual Investor "Top 5 for ‘25” On-Demand Conference.

As part of the event, Lawrence A. Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics, presented the top five reasons of why he believes the investment community and industry colleagues should pay attention to Outlook Therapeutics in 2025.

The on-demand video webcast is now accessible for viewing here and on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com).

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010 / LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the second quarter of calendar 2025. In the United States, ONS-5010 / LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.

Forward-Looking Statements

This press release and the on-demand video webcast contain forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans for commercial launch of LYTENAVA™ in Germany and the UK and the timing thereof, including the potential to launch with a partner, expected timing of revenue generation in Germany and the UK, the potential of ONS-5010 / LYTENAVA™ as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Germany and the UK, plans for commercial launch of ONS-5010 / LYTENAVA™ in additional countries, the potential to resubmit the BLA for ONS-5010 and the timing thereof, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including with respect to an additional clinical trial and CMC issues, expectations concerning decisions of regulatory bodies and the timing thereof, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the data from the NORSE EIGHT trial does not support the resubmission or subsequent filing by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release or the on-demand video webcast. All forward-looking statements included in this press release or the on-demand video webcast are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com


FAQ

What regulatory approvals has Outlook Therapeutics (OTLK) received for its bevacizumab formulation?

Outlook Therapeutics has received regulatory approval in the European Union (EU) and United Kingdom (UK) for its ophthalmic formulation of bevacizumab for treating wet AMD.

What is the significance of OTLK's bevacizumab approval in EU and UK?

It represents the first authorized use of an ophthalmic formulation of bevacizumab for wet AMD treatment in these markets.

What medical condition does OTLK's approved bevacizumab formulation treat?

The approved formulation treats wet age-related macular degeneration (wet AMD).

When did Outlook Therapeutics participate in the Virtual Investor Conference?

Outlook Therapeutics participated in the Virtual Investor 'Top 5 for '25' On-Demand Conference on February 19, 2025.

Outlook Therapeutics Inc

NASDAQ:OTLK

OTLK Rankings

OTLK Latest News

OTLK Stock Data

52.51M
23.60M
35.58%
35.63%
17.47%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
ISELIN