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Lipella Pharmaceuticals to Participate at H.C. Wainwright's 26th Annual Global Investment Conference in New York

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Lipella Pharmaceuticals (Nasdaq: LIPO) is set to participate in H.C. Wainwright's 26th Annual Global Investment Conference in New York City from September 9-11, 2024. The company will deliver a virtual presentation and offer one-on-one meetings for qualified investors at the Lotte New York Palace Hotel.

Lipella has two lead drug candidates in IND-approved phase 2 clinical trials for rare diseases, using the 505(b)(2) pathway:

  • LP-310: A liposomal-tacrolimus oral rinse for oral lichen planus (OLP), with topline data expected by year-end 2024.
  • LP-10: Liposomal tacrolimus for hemorrhagic cystitis (HC), with a phase 2b trial anticipated to start in the first half of 2025.

Both treatments target conditions with or no current therapeutic options in development, positioning Lipella as a potential leader in these rare disease markets.

Lipella Pharmaceuticals (Nasdaq: LIPO) parteciperà alla 26ª Conferenza Globale Annuale sugli Investimenti di H.C. Wainwright a New York dal 9 all'11 settembre 2024. L'azienda presenterà una relazione virtuale e offrirà incontri individuali per investitori qualificati presso il Lotte New York Palace Hotel.

Lipella ha due principali candidati farmaceutici in sperimentazione clinica di fase 2 approvata dalla IND per malattie rare, utilizzando il percorso 505(b)(2):

  • LP-310: Un collutorio a base di tacrolimus liposomiale per il lichen planus orale (OLP), con dati preliminari attesi entro la fine del 2024.
  • LP-10: Tacrolimus liposomiale per la cistite emorragica (HC), con un trial di fase 2b previsto per iniziare nella prima metà del 2025.

Entrambi i trattamenti mirano a condizioni per cui non sono attualmente disponibili opzioni terapeutiche in sviluppo, posizionando Lipella come potenziale leader in questi mercati delle malattie rare.

Lipella Pharmaceuticals (Nasdaq: LIPO) participará en la 26ª Conferencia Global Anual de Inversiones de H.C. Wainwright en Nueva York del 9 al 11 de septiembre de 2024. La compañía brindará una presentación virtual y ofrecerá reuniones individuales para inversores calificados en el Lotte New York Palace Hotel.

Lipella tiene dos principales candidatos a medicamentos en ensayos clínicos de fase 2 aprobados por la IND para enfermedades raras, utilizando la vía 505(b)(2):

  • LP-310: Un enjuague bucal de tacrolimus liposómico para el líquen plano oral (OLP), con datos preliminares esperados para finales de 2024.
  • LP-10: Tacrolimus liposómico para la cistitis hemorrágica (HC), con un ensayo de fase 2b anticipado para comenzar en la primera mitad de 2025.

Ambos tratamientos están dirigidos a condiciones para las que actualmente no hay opciones terapéuticas en desarrollo, posicionando a Lipella como un potencial líder en estos mercados de enfermedades raras.

리펠라 제약 (Nasdaq: LIPO)은 2024년 9월 9일부터 11일까지 뉴욕에서 열리는 H.C. 웨인라이트의 제26회 연례 글로벌 투자 컨퍼런스에 참여할 예정입니다. 회사는 가상 발표를 하고, 자격을 갖춘 투자자들을 위해 롯데 뉴욕 팔래스 호텔에서 일대일 미팅을 제공합니다.

리펠라에는 희귀 질환을 위한 IND 승인 2상 임상시험 중인 2개의 주요 약물 후보가 있습니다, 505(b)(2) 경로를 사용합니다:

  • LP-310: 구강 편평태선(OLP)을 위한 리포좀 타크로리무스 구강 세척제, 2024년 연말까지 주요 데이터 예상됩니다.
  • LP-10: 출혈성 방광염(HC)을 위한 리포좀 타크로리무스, 2025년 상반기 중 2b상 시험 시작 예정입니다.

두 치료법 모두 현재 개발 중인 치료 옵션이 없거나 극히 제한된 질환을 대상으로 하여 리펠라가 이들 희귀 질환 시장에서 잠재적인 선두주자로 자리잡을 수 있게 하고 있습니다.

Lipella Pharmaceuticals (Nasdaq: LIPO) participera à la 26e Conférence Annuelle Mondiale d'Investissement de H.C. Wainwright à New York du 9 au 11 septembre 2024. L'entreprise présentera une exposition virtuelle et proposera des réunions individuelles pour les investisseurs qualifiés à l'Hôtel Lotte New York Palace.

Lipella a deux candidats principaux en essai clinique de phase 2 approuvé par l'IND pour des maladies rares, utilisant la voie 505(b)(2) :

  • LP-310 : Un bain de bouche à base de tacrolimus liposomale pour le lichen planus oral (OLP), avec des données préliminaires attendues d'ici la fin de 2024.
  • LP-10 : Tacrolimus liposomale pour la cystite hémorragique (HC), avec un essai de phase 2b prévu pour commencer au premier semestre 2025.

Les deux traitements ciblent des conditions pour lesquelles aucune option thérapeutique n'est actuellement en développement, positionnant Lipella comme un potentiel leader dans ces marchés de maladies rares.

Lipella Pharmaceuticals (Nasdaq: LIPO) wird an der 26. jährlichen Global Investment Conference von H.C. Wainwright in New York City vom 9. bis 11. September 2024 teilnehmen. Das Unternehmen wird eine virtuelle Präsentation abhalten und Einzelgespräche für qualifizierte Investoren im Lotte New York Palace Hotel anbieten.

Lipella hat zwei Hauptmedikamentenkandidaten in IND-zugelassenen klinischen Studien der Phase 2 für seltene Krankheiten, die den 505(b)(2)-Weg nutzen:

  • LP-310: Eine liposomale Tacrolimus-Spülung für lichen planus oral (OLP), mit den wichtigsten Daten, die bis Ende 2024 erwartet werden.
  • LP-10: Liposomales Tacrolimus für hämorrhagische Zystitis (HC), mit einem Phase 2b-Test, der für die erste Hälfte von 2025 erwartet wird.

Beide Behandlungen zielen auf Zustände ab, für die derzeit keine therapeutischen Optionen in Entwicklung vorhanden sind, was Lipella als potenziellen Marktführer in diesen seltenen Krankheitsmärkten positioniert.

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Company has two lead drug candidates for rare disease indications in IND approved phase 2 clinical trials using the 505(b)(2) pathway

PITTSBURGH, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals, Inc. (Nasdaq: LIPO) (“Lipella”) will participate at H.C. Wainwright's 26th Annual Global Investment Conference in New York City at the Lotte New York Palace Hotel on September 9 through 11, 2024.

Admission to H.C. Wainwright’s conference is for qualified investors, and Lipella will be giving a virtual presentation and management will be available for one-on-one meetings onsite. For more information and/or to register for the Global Investment Conference, please visit: HCW Events

H.C. Wainwright's 26th Annual Global Investment Conference:

  • Date: September 9 through 11, 2024
  • Location: Lotte New York Palace Hotel
  • Webcast: Available on the “Events & Presentations” section of the Company’s website
  • 1x1 Meetings: Please contact your HCW representative
  • Conference Registration: HERE
  • Website: HERE

Lead Drug Candidates:
Lipella has two lead drug candidates for rare disease indications in IND approved phase 2 clinical trials using the 505(b)(2) pathway:

  • LP-310: A novel liposomal-tacrolimus oral rinse based on the company's lead candidate LP-10, for the treatment of oral lichen planus (OLP)
    • Oral rinse formulation of LP-10 for the treatment for OLP
    • High safety profile with no systemic toxicity projected
    • There are no current topical OLP treatments in development
    • First 2 patients dosed with topline data expected by year-end 2024

  • LP-10: Liposomal tacrolimus for the treatment of Hemorrhagic cystitis (HC)
    • LP-10 has a well-established mechanism of action and has demonstrated safety and efficacy in Phase 2a studies
    • LP-10 is the only therapeutic for Hemorrhagic cystitis in development
    • Anticipate phase 2b trial to start in 1st half 2025

About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements
This press release includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,” “could,” “continue,” “would,” “should,” “potential,” “target,” “goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “predicts,” “expects,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
646-863-6893


FAQ

When and where is Lipella Pharmaceuticals (LIPO) participating in H.C. Wainwright's Global Investment Conference?

Lipella Pharmaceuticals (LIPO) is participating in H.C. Wainwright's 26th Annual Global Investment Conference from September 9-11, 2024, at the Lotte New York Palace Hotel in New York City.

What are Lipella Pharmaceuticals' (LIPO) two lead drug candidates currently in clinical trials?

Lipella Pharmaceuticals' (LIPO) two lead drug candidates are LP-310, a liposomal-tacrolimus oral rinse for oral lichen planus, and LP-10, a liposomal tacrolimus treatment for hemorrhagic cystitis. Both are in IND-approved phase 2 clinical trials.

When does Lipella Pharmaceuticals (LIPO) expect topline data for its LP-310 oral lichen planus treatment?

Lipella Pharmaceuticals (LIPO) expects to have topline data for its LP-310 oral lichen planus treatment by the end of 2024.

What is the projected timeline for Lipella Pharmaceuticals' (LIPO) phase 2b trial of LP-10 for hemorrhagic cystitis?

Lipella Pharmaceuticals (LIPO) anticipates starting the phase 2b trial of LP-10 for hemorrhagic cystitis in the first half of 2025.

What regulatory pathway is Lipella Pharmaceuticals (LIPO) using for its drug candidates?

Lipella Pharmaceuticals (LIPO) is using the 505(b)(2) regulatory pathway for its drug candidates, which can potentially expedite the approval process for drugs with previously established safety and efficacy profiles.

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