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[8-K] Willis Lease Finance Corp Reports Material Event

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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) filed a Form 8-K on 15 July 2025 to disclose a patent milestone for its commercial product Igalmi. The U.S. Patent & Trademark Office has allowed U.S. Patent Application No. 18/600,419, which covers administration of a single oromucosal dose of up to 120 mcg dexmedetomidine for treating acute agitation associated with schizophrenia or bipolar disorder in patients exhibiting a QT prolongation of <6 µs. Once issued, the patent will be eligible for Orange Book listing and will become the 14th Orange Book-listed patent for Igalmi. The patent carries an expiry date of 12 January 2043, subject to any patent-term adjustment. No financial metrics or other operational updates were included in this filing.

  • Form type: 8-K – Item 8.01 (Other Events)
  • Event date: 15 July 2025
  • Key asset: Igalmi (dexmedetomidine oromucosal film)
  • IP impact: additional Orange Book protection through 2043, strengthening the product’s U.S. exclusivity position

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) ha presentato un modulo 8-K il 15 luglio 2025 per comunicare un traguardo brevettuale relativo al suo prodotto commerciale Igalmi. L'Ufficio Brevetti e Marchi degli Stati Uniti ha accettato la domanda di brevetto statunitense n. 18/600,419, che riguarda la somministrazione di una singola dose oromucosa fino a 120 mcg di dexmedetomidina per il trattamento dell'agitazione acuta associata a schizofrenia o disturbo bipolare in pazienti con prolungamento del QT inferiore a 6 µs. Una volta rilasciato, il brevetto potrà essere inserito nell'Orange Book e diventerà il quattordicesimo brevetto elencato per Igalmi. La scadenza del brevetto è fissata al 12 gennaio 2043, soggetta a eventuali aggiustamenti del termine di validità. Nel documento non sono stati inclusi dati finanziari o altri aggiornamenti operativi.

  • Tipo di modulo: 8-K – Punto 8.01 (Altri eventi)
  • Data dell'evento: 15 luglio 2025
  • Principale asset: Igalmi (film oromucosale a base di dexmedetomidina)
  • Impatto sulla proprietà intellettuale: ulteriore protezione nell'Orange Book fino al 2043, rafforzando la posizione di esclusività del prodotto negli Stati Uniti

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) presentó un Formulario 8-K el 15 de julio de 2025 para divulgar un hito de patente relacionado con su producto comercial Igalmi. La Oficina de Patentes y Marcas de Estados Unidos ha aprobado la solicitud de patente estadounidense n.º 18/600,419, que cubre la administración de una dosis oromucosa única de hasta 120 mcg de dexmedetomidina para tratar la agitación aguda asociada con esquizofrenia o trastorno bipolar en pacientes con una prolongación del QT menor a 6 µs. Una vez emitida, la patente será elegible para su inclusión en el Orange Book y se convertirá en la decimocuarta patente listada para Igalmi. La patente tiene una fecha de vencimiento del 12 de enero de 2043, sujeta a cualquier ajuste del término de la patente. No se incluyeron métricas financieras ni otras actualizaciones operativas en esta presentación.

  • Tipo de formulario: 8-K – Ítem 8.01 (Otros eventos)
  • Fecha del evento: 15 de julio de 2025
  • Activo clave: Igalmi (film oromucosal de dexmedetomidina)
  • Impacto en la propiedad intelectual: protección adicional en el Orange Book hasta 2043, fortaleciendo la posición de exclusividad del producto en EE.UU.

BioXcel Therapeutics, Inc. (나스닥: BTAI)는 2025년 7월 15일에 상업 제품 Igalmi 관련 특허 이정표를 공개하기 위해 Form 8-K를 제출했습니다. 미국 특허청은 미국 특허 출원번호 18/600,419를 허가했으며, 이는 QT 연장 시간이 6µs 미만인 조현병 또는 양극성 장애 환자의 급성 초조증 치료를 위해 최대 120mcg의 덱스메데토미딘 단일 구강점막 투여를 포함합니다. 특허가 발급되면 Orange Book 등재 자격을 갖추게 되며, Igalmi의 14번째 Orange Book 등재 특허가 됩니다. 특허 만료일은 2043년 1월 12일이며, 특허 기간 조정에 따라 변경될 수 있습니다. 이번 제출서에는 재무 지표나 기타 운영 업데이트는 포함되지 않았습니다.

  • 서류 유형: 8-K – 항목 8.01 (기타 이벤트)
  • 이벤트 날짜: 2025년 7월 15일
  • 핵심 자산: Igalmi (덱스메데토미딘 구강점막 필름)
  • 지적 재산 영향: 2043년까지 추가적인 Orange Book 보호, 미국 내 제품 독점권 강화

BioXcel Therapeutics, Inc. (Nasdaq : BTAI) a déposé un formulaire 8-K le 15 juillet 2025 pour divulguer une étape importante de brevet concernant son produit commercial Igalmi. L'Office des brevets et des marques des États-Unis a accepté la demande de brevet américaine n° 18/600,419, qui couvre l'administration d'une dose oromucosale unique allant jusqu'à 120 mcg de dexmédétomidine pour traiter l'agitation aiguë associée à la schizophrénie ou au trouble bipolaire chez des patients présentant une prolongation du QT inférieure à 6 µs. Une fois délivré, le brevet sera éligible à l'inscription dans le Orange Book et deviendra le 14e brevet inscrit pour Igalmi. Le brevet expire le 12 janvier 2043, sous réserve de tout ajustement de la durée du brevet. Aucun indicateur financier ni autre mise à jour opérationnelle n'a été inclus dans ce dépôt.

  • Type de formulaire : 8-K – Point 8.01 (Autres événements)
  • Date de l'événement : 15 juillet 2025
  • Actif clé : Igalmi (film oromucosal de dexmédétomidine)
  • Impact sur la propriété intellectuelle : protection supplémentaire dans l'Orange Book jusqu'en 2043, renforçant la position d'exclusivité du produit aux États-Unis

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) reichte am 15. Juli 2025 ein Formular 8-K ein, um einen Patentreife-Meilenstein für sein kommerzielles Produkt Igalmi offenzulegen. Das US-Patent- und Markenamt hat die US-Patentanmeldung Nr. 18/600,419 genehmigt, die die Verabreichung einer einzelnen oromukosalen Dosis von bis zu 120 mcg Dexmedetomidin zur Behandlung akuter Unruhe im Zusammenhang mit Schizophrenie oder bipolaren Störungen bei Patienten mit einer QT-Verlängerung von weniger als 6 µs abdeckt. Nach Erteilung wird das Patent für die Aufnahme in das Orange Book berechtigt sein und das 14. im Orange Book gelistete Patent für Igalmi darstellen. Das Patent läuft am 12. Januar 2043 ab, vorbehaltlich etwaiger Patentlaufzeitverlängerungen. Finanzielle Kennzahlen oder andere operative Updates wurden in dieser Einreichung nicht angegeben.

  • Formulartyp: 8-K – Punkt 8.01 (Sonstige Ereignisse)
  • Datum des Ereignisses: 15. Juli 2025
  • Schlüsselprodukt: Igalmi (Dexmedetomidin oromukosaler Film)
  • Auswirkung auf geistiges Eigentum: zusätzliche Orange Book-Schutzrechte bis 2043, Stärkung der US-Exklusivitätsposition des Produkts
Positive
  • None.
Negative
  • None.

Insights

Newly allowed patent extends Igalmi exclusivity to 2043 and adds 14th Orange Book listing, a positive IP development despite lack of immediate financial metrics.

The allowance of Application 18/600,419 materially expands BioXcel’s intellectual-property shield around Igalmi. With an expiry in 2043, the company secures roughly 17.5 more years of statutory protection from the allowance date, which may deter generic challengers during that window. While the filing contains no sales or earnings data, patent additions of this length are typically viewed favorably by investors who value prolonged revenue visibility. Because this 8-K is focused solely on the IP event, the disclosure is impactful yet limited in scope, warranting a positive rating.

Orange Book eligibility of USPTO-allowed single-dose dexmedetomidine patent tightens Igalmi’s patent estate through 2043, complicating generic entry timelines.

The patent’s claims track the FDA-recommended dosing for Igalmi in a defined subpopulation, enhancing enforceability because they mirror the approved label. Orange Book listing provides an automatic notification framework—any ANDA filer must certify against this patent, triggering potential 30-month stays if contested. Becoming the 14th Orange Book patent, the estate now covers both formulation and method-of-use aspects, creating layered barriers. The 2043 expiry materially lengthens exclusivity relative to standard 20-year terms, signaling strong protection for the product’s commercial life cycle.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) ha presentato un modulo 8-K il 15 luglio 2025 per comunicare un traguardo brevettuale relativo al suo prodotto commerciale Igalmi. L'Ufficio Brevetti e Marchi degli Stati Uniti ha accettato la domanda di brevetto statunitense n. 18/600,419, che riguarda la somministrazione di una singola dose oromucosa fino a 120 mcg di dexmedetomidina per il trattamento dell'agitazione acuta associata a schizofrenia o disturbo bipolare in pazienti con prolungamento del QT inferiore a 6 µs. Una volta rilasciato, il brevetto potrà essere inserito nell'Orange Book e diventerà il quattordicesimo brevetto elencato per Igalmi. La scadenza del brevetto è fissata al 12 gennaio 2043, soggetta a eventuali aggiustamenti del termine di validità. Nel documento non sono stati inclusi dati finanziari o altri aggiornamenti operativi.

  • Tipo di modulo: 8-K – Punto 8.01 (Altri eventi)
  • Data dell'evento: 15 luglio 2025
  • Principale asset: Igalmi (film oromucosale a base di dexmedetomidina)
  • Impatto sulla proprietà intellettuale: ulteriore protezione nell'Orange Book fino al 2043, rafforzando la posizione di esclusività del prodotto negli Stati Uniti

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) presentó un Formulario 8-K el 15 de julio de 2025 para divulgar un hito de patente relacionado con su producto comercial Igalmi. La Oficina de Patentes y Marcas de Estados Unidos ha aprobado la solicitud de patente estadounidense n.º 18/600,419, que cubre la administración de una dosis oromucosa única de hasta 120 mcg de dexmedetomidina para tratar la agitación aguda asociada con esquizofrenia o trastorno bipolar en pacientes con una prolongación del QT menor a 6 µs. Una vez emitida, la patente será elegible para su inclusión en el Orange Book y se convertirá en la decimocuarta patente listada para Igalmi. La patente tiene una fecha de vencimiento del 12 de enero de 2043, sujeta a cualquier ajuste del término de la patente. No se incluyeron métricas financieras ni otras actualizaciones operativas en esta presentación.

  • Tipo de formulario: 8-K – Ítem 8.01 (Otros eventos)
  • Fecha del evento: 15 de julio de 2025
  • Activo clave: Igalmi (film oromucosal de dexmedetomidina)
  • Impacto en la propiedad intelectual: protección adicional en el Orange Book hasta 2043, fortaleciendo la posición de exclusividad del producto en EE.UU.

BioXcel Therapeutics, Inc. (나스닥: BTAI)는 2025년 7월 15일에 상업 제품 Igalmi 관련 특허 이정표를 공개하기 위해 Form 8-K를 제출했습니다. 미국 특허청은 미국 특허 출원번호 18/600,419를 허가했으며, 이는 QT 연장 시간이 6µs 미만인 조현병 또는 양극성 장애 환자의 급성 초조증 치료를 위해 최대 120mcg의 덱스메데토미딘 단일 구강점막 투여를 포함합니다. 특허가 발급되면 Orange Book 등재 자격을 갖추게 되며, Igalmi의 14번째 Orange Book 등재 특허가 됩니다. 특허 만료일은 2043년 1월 12일이며, 특허 기간 조정에 따라 변경될 수 있습니다. 이번 제출서에는 재무 지표나 기타 운영 업데이트는 포함되지 않았습니다.

  • 서류 유형: 8-K – 항목 8.01 (기타 이벤트)
  • 이벤트 날짜: 2025년 7월 15일
  • 핵심 자산: Igalmi (덱스메데토미딘 구강점막 필름)
  • 지적 재산 영향: 2043년까지 추가적인 Orange Book 보호, 미국 내 제품 독점권 강화

BioXcel Therapeutics, Inc. (Nasdaq : BTAI) a déposé un formulaire 8-K le 15 juillet 2025 pour divulguer une étape importante de brevet concernant son produit commercial Igalmi. L'Office des brevets et des marques des États-Unis a accepté la demande de brevet américaine n° 18/600,419, qui couvre l'administration d'une dose oromucosale unique allant jusqu'à 120 mcg de dexmédétomidine pour traiter l'agitation aiguë associée à la schizophrénie ou au trouble bipolaire chez des patients présentant une prolongation du QT inférieure à 6 µs. Une fois délivré, le brevet sera éligible à l'inscription dans le Orange Book et deviendra le 14e brevet inscrit pour Igalmi. Le brevet expire le 12 janvier 2043, sous réserve de tout ajustement de la durée du brevet. Aucun indicateur financier ni autre mise à jour opérationnelle n'a été inclus dans ce dépôt.

  • Type de formulaire : 8-K – Point 8.01 (Autres événements)
  • Date de l'événement : 15 juillet 2025
  • Actif clé : Igalmi (film oromucosal de dexmédétomidine)
  • Impact sur la propriété intellectuelle : protection supplémentaire dans l'Orange Book jusqu'en 2043, renforçant la position d'exclusivité du produit aux États-Unis

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) reichte am 15. Juli 2025 ein Formular 8-K ein, um einen Patentreife-Meilenstein für sein kommerzielles Produkt Igalmi offenzulegen. Das US-Patent- und Markenamt hat die US-Patentanmeldung Nr. 18/600,419 genehmigt, die die Verabreichung einer einzelnen oromukosalen Dosis von bis zu 120 mcg Dexmedetomidin zur Behandlung akuter Unruhe im Zusammenhang mit Schizophrenie oder bipolaren Störungen bei Patienten mit einer QT-Verlängerung von weniger als 6 µs abdeckt. Nach Erteilung wird das Patent für die Aufnahme in das Orange Book berechtigt sein und das 14. im Orange Book gelistete Patent für Igalmi darstellen. Das Patent läuft am 12. Januar 2043 ab, vorbehaltlich etwaiger Patentlaufzeitverlängerungen. Finanzielle Kennzahlen oder andere operative Updates wurden in dieser Einreichung nicht angegeben.

  • Formulartyp: 8-K – Punkt 8.01 (Sonstige Ereignisse)
  • Datum des Ereignisses: 15. Juli 2025
  • Schlüsselprodukt: Igalmi (Dexmedetomidin oromukosaler Film)
  • Auswirkung auf geistiges Eigentum: zusätzliche Orange Book-Schutzrechte bis 2043, Stärkung der US-Exklusivitätsposition des Produkts
0001018164false00010181642025-07-152025-07-15

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): July 15, 2025
 
Willis Lease Finance Corporation
(Exact Name of Registrant as Specified in Charter)
 
Delaware 001-15369 68-0070656
(State or Other Jurisdiction
of Incorporation)
 (Commission File
Number)
 (I.R.S. Employer
Identification Number)
 
4700 Lyons Technology Parkway
Coconut Creek, FL 33073
(Address of Principal Executive Offices) (Zip Code)
 
Registrant’s telephone number, including area code: (561349-9989
 
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:
 
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 Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Each ClassTrading SymbolName of exchange on which registered
Common Stock, $0.01 par value per shareWLFCNasdaq Global Market
 
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. o





Item 7.01 Regulation FD Disclosure.

On July 15, 2025, Willis Lease Finance Corporation (NASDAQ: WLFC) (the “Company”) issued a press release announcing that it plans to conduct a conference call on Tuesday, August 5, 2025, at 10:00 a.m. Eastern Time to discuss its financial results for the second quarter of 2025. The Company will report its financial results in a press release prior to the conference call.

A copy of the press release is included as Exhibit 99.1 to this Current Report on Form 8-K.

The foregoing information, including the press release attached hereto as Exhibit 99.1, is being furnished pursuant to Item 7.01 of this Current Report on Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements & Exhibits.

Exhibit No.Description
99.1
News Release issued by Willis Lease Finance Corporation dated July 15, 2025.
104Cover Page Interactive Data File (embedded within the Inline XBRL document).


2


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 duly authorized officer.
 
Dated: July 15, 2025
 
 
 WILLIS LEASE FINANCE CORPORATION
  
 By:/s/ Scott B. Flaherty
 Scott B. Flaherty
 Executive Vice President and Chief Financial Officer

3
Willis Lease

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