Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance
Celcuity (NASDAQ:CELC) has significantly expanded its senior secured credit facility with Innovatus Capital Partners and Oxford Finance to $500 million, up from its previous amount. The enhanced facility includes $350 million in committed capital and an additional $150 million at mutual discretion.
The amendment provides $170 million in new committed capital, including $100 million tied to FDA approval of gedatolisib for second-line wild-type advanced breast cancer, and $120 million linked to commercial revenue milestones. The initial funding was $30 million, bringing the total outstanding loan to $130 million. The deal extends the interest-only period by 14 months, with a potential 7-month extension upon FDA approval.
Celcuity (NASDAQ:CELC) ha ampliato considerevolmente la sua linea di credito senior garantita con Innovatus Capital Partners e Oxford Finance portandola a 500 milioni di dollari, rispetto all’importo precedente. La nuova facility comprende 350 milioni di dollari di capitale impegnato e ulteriori 150 milioni di dollari a discrezione comune.
L’emendamento prevede 170 milioni di dollari di nuovo capitale impegnato, inclusi 100 milioni condizionati all’approvazione FDA di gedatolisib per il carcinoma mammario avanzato wild-type di seconda linea, e 120 milioni legati al raggiungimento di target di ricavi commerciali. Il finanziamento iniziale è stato di 30 milioni, portando il prestito totale in essere a 130 milioni. L’accordo estende il periodo di sola maturazione degli interessi di 14 mesi, con una possibile estensione di 7 mesi in caso di approvazione FDA.
Celcuity (NASDAQ:CELC) amplió significativamente su línea de crédito senior garantizada con Innovatus Capital Partners y Oxford Finance hasta los 500 millones de dólares, frente al importe anterior. La facility mejorada incluye 350 millones de dólares de capital comprometido y 150 millones de dólares adicionales a discreción mutua.
La enmienda aporta 170 millones de dólares de nuevo capital comprometido, entre ellos 100 millones condicionados a la aprobación de la FDA para gedatolisib en cáncer de mama avanzado wild-type de segunda línea, y 120 millones vinculados a hitos de ingresos comerciales. La financiación inicial fue de 30 millones, dejando el préstamo total pendiente en 130 millones. El acuerdo amplía el periodo sólo de intereses en 14 meses, con una posible prórroga de 7 meses si la FDA aprueba el fármaco.
Celcuity (NASDAQ:CELC)는 Innovatus Capital Partners 및 Oxford Finance와의 담보부 선순위 신용한도를 이전보다 대폭 확대하여 5억 달러로 증액했습니다. 확장된 시설은 3.5억 달러의 확약 자금과 추가로 상호 재량에 따른 1.5억 달러를 포함합니다.
이번 수정안은 1.7억 달러의 신규 확약 자금을 제공하며, 그중 1억 달러는 2차 라인의 야생형(와일드타입) 진행성 유방암에 대한 gedatolisib의 FDA 승인에 연동되고, 1.2억 달러는 상업적 매출 성과에 연계됩니다. 초기 자금은 3천만 달러였으며, 총 미상환 대출액은 1.3억 달러입니다. 이 거래는 이자만 납부하는 기간을 14개월 연장하며, FDA 승인 시 추가로 7개월 연장할 수 있습니다.
Celcuity (NASDAQ:CELC) a considérablement renforcé sa facilité de crédit senior garantie avec Innovatus Capital Partners et Oxford Finance, la portant à 500 millions de dollars, contre un montant inférieur auparavant. La facilité élargie comprend 350 millions de dollars de capital engagé et 150 millions de dollars supplémentaires à discrétion commune.
L’amendement prévoit 170 millions de dollars de nouveau capital engagé, dont 100 millions conditionnés à l’approbation par la FDA de gedatolisib pour le cancer du sein avancé wild-type de deuxième ligne, et 120 millions liés à des jalons de revenus commerciaux. Le financement initial était de 30 millions, portant le prêt total en cours à 130 millions. L’accord prolonge la période de paiement des intérêts uniquement de 14 mois, avec une possible extension de 7 mois en cas d’approbation par la FDA.
Celcuity (NASDAQ:CELC) hat seine besicherte Senior-Kreditlinie mit Innovatus Capital Partners und Oxford Finance deutlich auf 500 Millionen US-Dollar ausgeweitet. Die erweiterte Facility umfasst 350 Millionen US-Dollar an zugesagtem Kapital sowie zusätzliche 150 Millionen US-Dollar nach gemeinsamer Entscheidung.
Die Änderung sieht 170 Millionen US-Dollar neues zugesagtes Kapital vor, darunter 100 Millionen, die an eine FDA-Zulassung von Gedatolisib für die Zweitlinienbehandlung des wildtypischen fortgeschrittenen Brustkrebses gekoppelt sind, sowie 120 Millionen, die an kommerzielle Umsatzziele gebunden sind. Die anfängliche Auszahlung betrug 30 Millionen, womit der ausstehende Kredit insgesamt 130 Millionen beträgt. Das Abkommen verlängert die Zinszahlungsphase um 14 Monate mit einer möglichen weiteren Verlängerung um 7 Monate bei FDA-Zulassung.
- Secured significant funding increase to $500 million total facility size
- Extended interest-only period by 14 months with additional 7-month extension possibility
- Received $30 million initial funding, bringing total term loan to $130 million
- Gained access to $100 million upon FDA approval of gedatolisib
- Enhanced financial flexibility following positive Phase 3 VIKTORIA-1 trial results
- Increased debt obligation with $130 million currently outstanding
- $150 million portion of facility requires mutual lender approval
- Revenue milestone requirements for accessing $120 million portion
Insights
Celcuity secures $500M loan facility, significantly strengthening its financial position to support gedatolisib commercialization following positive Phase 3 results.
Celcuity has substantially improved its financial position by upsizing its loan facility to
This financing represents a strategic capital infusion at a critical juncture following positive Phase 3 clinical data for gedatolisib in PIK3CA wild-type advanced breast cancer patients. The structure includes
The 14-month extension of the interest-only period (with potential for an additional 7 months upon FDA approval) significantly reduces near-term cash burn, allowing Celcuity to direct resources toward the rolling NDA submission via FDA's Real-Time Oncology Review (RTOR) program and commercial launch preparations.
This debt-based approach enables Celcuity to fund its commercialization strategy without immediate equity dilution, though investors should note the increased leverage. The transaction signals lender confidence in gedatolisib's commercial potential following the positive VIKTORIA-1 study results in the second-line setting for advanced breast cancer patients who have progressed after CDK4/6 inhibitor therapy.
MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and Oxford Finance LLC, and its affiliates (together, “Oxford”). The amendment increases the total term loan facility size to
Highlights of the amended credit facility include:
- Increased Capital Availability: Adds
$170 million in new committed capital, including an additional$50 million for a total of$100 million available upon U.S. Food and Drug Administration (“FDA”) approval of gedatolisib in second-line wild-type advanced breast cancer (“ABC”) patients post-CDK4/6 inhibitor therapy, and$120 million upon achievement of certain commercial revenue milestones. An additional up to$150 million is also available at the mutual discretion of Celcuity and its lenders. - Improved Structure and Financial Flexibility: Extends the interest-only period by 14 months, with an additional seven-month extension available upon FDA approval. The maturity date of the facility was also extended by six months.
The amendment significantly enhances Celcuity’s financial flexibility and access to capital following the positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study. The upsized facility strengthens Celcuity's ability to manage its capital structure efficiently while providing additional funding to support the rolling submission to FDA of its New Drug Application (“NDA”) via FDA’s RTOR program, commercial launch preparations for gedatolisib, and other strategic initiatives.
A Form 8-K outlining the material terms of the amended credit facility will be filed with the Securities and Exchange Commission.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (PAM) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment of and reported topline data for the PIK3CA wild-type cohort, and is currently enrolling patients for the PIK3CA mutant cohort. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
About Innovatus Capital Partners, LLC
Innovatus Capital Partners, LLC, is an independent adviser and asset management firm with approximately
About Oxford Finance
Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private companies in a variety of industries worldwide. For over 20 years, Oxford has delivered flexible financing solutions to over 700 companies, allowing borrowers to maximize their equity by leveraging their assets. Since 2002, Oxford has originated more than
Forward-Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the ability of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of NDA submissions and our ability to obtain FDA approval to commercialize gedatolisib under the RTOR program; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
View source version on release on GlobeNewswire.com.
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
763-392-0123
ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
SOURCE: Celcuity Inc.
FAQ
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