Hauptforum Cellectar Biosciences WKN: A3DQSD ISIN: US15117F8077 Kürzel: CLRB Forum: Aktien User: SVGO

https://www.oncologypipeline.com/apexonco/radiopharma-doubts-mount-cellectar Das beschreibt die aktuelle Lage ganz gut

Also ist meine Einschätzung. Habe ich auch irgendwo zusätzlich gelesen . Woanders habe ich gelesen, dass sie den Antrag im 4. Quartal einreichen wollen. Gibt aber auch mehrere andere grünce

Die Ergebnisse sind nicht gut genug, dass eine Phase 2 ausreicht. Es wird jetzt stark damit gerechnet, dass die FDA einen Antrag nicht direkt annimmt und nun eine Phase 3 verlangt. Das würde das Unternehmen um mindestens 4 Jahre zurückwerfen

Aber warum?

Kurs geht in Keller

https://investor.cellectar.com/press-releases/detail/338/cellectar-biosciences-iopofosine-i-131-exceeds-primary

https://www.cellectar.com/news-media/press-releases/detail/337/cellectar-biosciences-announces-exercise-of-tranche-b

https://investor.cellectar.com/all-sec-filings

Mutig

Nein. Es ist wahrscheinlich ein „Sell the good News“ Moment. Der Wert kommt wieder. Antrag auf Zulassung im zweiten Halbjahr geplant. Wenn der Antrag eingereicht wird, geht hier die Post ab. Wenn sechs Monate später die Zulassung durch die FDA erfolgen sollte, dann gibt es hier ein Feuerwerk. Dazwischen ggf noch News zu Partnerschaft mit großem Pharmakonzern, Buyout, wer weiß. Hier ist die kommenden 12 Monate viel Musik drin. Ich hab aufgestockt

Sind die zahlen schlecht?

Antrag bei FDA im 2. Halbjahr 2024!!!

“2023 was a year of significant progress for Cellectar, culminating in the January announcement of the positive data from our pivotal study of iopofosine I 131 in Waldenstrom’s macroglobulinemia,” said James Caruso, president, and CEO of Cellectar. “We continue to focus on the preparation of our NDA, which we plan to submit in the second half of 2024 and in parallel request accelerated approval, which if granted, would provide a six-month review period for the NDA. Our data in WM is truly impressive and we look forward to providing this meaningful new therapeutic for patients in a disease with limited treatment options.”

2023 Financial Highlights Cash and Cash Equivalents: As of December 31, 2023, the company had cash and cash equivalents of $9.6 million, compared to $19.9 million as of December 31, 2022. The decrease in cash was primarily a result of research and development expenses, and general and administrative expenses. Net cash used in operating activities during the twelve months ended December 31, 2023, was approximately $32.4 million. Net cash proceeds from the issuance of common stock, preferred stock, and warrants during 2023 was approximately $22.9 million. We believe our cash balance as of December 31, 2023, in combination with the funds generated by the warrants exercised by investors in January 2024 is adequate to fund our basic budgeted operations into the fourth quarter of 2024. Research and Development Expense: R&D expense for the year ended December 31, 2023, was approximately $28.2 million, compared to approximately $19.2 million for the year ended December 31, 2022. The overall increase in R&D expense was primarily a result of an increase in manufacturing and related costs related to greater production sourcing necessary to support clinical trials and establish commercial production capabilities. General and Administrative Expense: G&A expense for the year ended December 31, 2023, was $10.7 million, compared to $9.6 million for the year ended December 31, 2022. The increase in G&A costs was primarily a result of an increase in personnel costs partially offset by a reduction in professional fees. Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2023, was ($38.0) million, or $(3.11) per share, compared to $(28.6) million, or ($4.05) per share in the year ended December 31, 2022.

Zahlen sind da

https://investor.cellectar.com/press-releases/detail/331/cellectar-biosciences-reports-financial-results-for-year