2seventy bio

“In our first full year of operations, 2seventy made tremendous strides across all aspects of our business: from advancing early-stage research, building out manufacturing capabilities, initiating clinical studies, and delivering to patients in the commercial setting with Abecma,” said Nick Leschly, chief kairos officer. “Bolstered by strong growth in the fourth quarter, we delivered Abecma to hundreds of patients with multiple myeloma in the U.S. and expect continued strong growth in 2023. With our partners at BMS, we continue to develop this product into earlier lines of multiple myeloma treatment on the back of positive data from the KarMMa-3 study and the planned KarMMa-9 study and continue to grow our manufacturing capabilities to support a potential peak sales opportunity of $2-3 billion in the U.S. With our recent financing and the growth of Abecma, we are in a strong position to continue to prudently advance our clinical and preclinical pipeline, driving towards delivering proof-of-concept data this year for our bbT369 and SC-DARIC33 programs and advancement of MUC and MAGE solid tumor programs to IND by the end of the year. I couldn’t be more optimistic for what lies ahead in 2023 and the position we are in today, and that is thanks to the hard work of our employees, the patients and physicians who participate in our studies, and our shareholders who share in our mission to deliver more time to patients with cancer.”

Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS), reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) fourth quarter revenues of $94 million, which represents 25% growth over the prior quarter, and 40% growth over the fourth quarter of 2021, and full year revenues of $297 million, which is in line with our stated 2022 U.S. Abecma revenue guidance of $250-300 million, in each case such revenue is shared equally with BMS. Assuming continued strong demand for Abecma and achievement of planned increases in manufacturing capacity throughout the year, we anticipate topline 2023 U.S. revenues of $470-570 million.

Assuming continued increases in manufacturing capacity and growth in the addressable patient population based on an anticipated approval in 3L+ multiple myeloma, we expect Abecma to generate $200-300 million in operating income for 2seventy bio in the 2024-25 period.

We reported Abecma-related collaborative arrangement revenue of $8.7 million for the fourth quarter of 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the year.

Financial Guidance
At the end of February 2023, 2seventy bio raised approximately $117 million in net proceeds through a public equity offering. Based on our current operating plans, which includes these net proceeds and the ongoing commercialization of Abecma, we believe our current cash position will be sufficient to fund operations into 2026.

“The financial outlook for 2seventy continues to strengthen, and the recent equity financing puts us in a privileged position, with cash runway now into 2026,” said Chip Baird, chief financial officer. “We expect the cash flow from the Abecma collaboration to grow significantly over the 2023-25 time period, which will continue to reduce our annual net cash spend and our need for future capital infusions. Our pipeline programs have the potential to deliver meaningful benefit for cancer patients and we will balance an entrepreneurial mindset with a disciplined approach to capital allocation.”

RECENT HIGHLIGHTS
KARMMA-3 DATA IN NEJM - On February 10, 2023, 2seventy announced the publication of our KarMMa-3 data in the New England Journal of Medicine. The positive results of this pivotal Phase 3 showed at median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001). This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor (CAR) T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. 2seventy and BMS anticipate submitting an sBLA to the FDA in the first quarter of 2023 to seek approval in the third line setting.

REGENERON COLLABORATION AMENDMENT – In January, 2seventy bio announced an expanded translational collaboration with Regeneron to facilitate the acceleration of novel cell therapy-based combinations for solid tumors. The collaboration will leverage 2seventy bio’s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron’s differentiated antibodies and bispecifics. To support this expanded clinical development plan Regeneron made an approximately $20 million equity investment in 2seventy bio at a 50% premium and has committed to another approximately $20 million in near-term pre-clinical and clinical milestones. The parties will continue sharing costs for these activities in a manner largely consistent with the existing agreement, with Regeneron covering 75% of certain preclinical costs necessary to study combinations and 100% of the costs for the arms of the clinical studies that include Regeneron agents through regulatory approval. For other programs, cost-sharing will follow the existing 50/50 cost sharing agreement.

BOARD APPOINTMENT – Earlier this month, 2seventy bio announced the appointment of Wei Lin, M.D. to the company’s Board of Directors.

UPCOMING ANTICIPATED MILESTONES
ABECMA

   Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma by end of 2023
   Potential FDA approval of sBLA in 3L+ multiple myeloma by the end of 2023

PIPELINE

   Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023
   Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia by the end of 2023
   Submission of an IND for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron by end of 2023
   Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors by end of 2023

FINANCIAL GUIDANCE

   Topline U.S. Abecma revenue of $470-570 million in 2023
   Net cash spend of $180-220 million in 2023
   Cash runway into 2026"

Juno Therapeutics ist ein weiterer Wettbewerber, der 2018 von Celgene übernommen wurde. Das Unternehmen ist dafür bekannt, dass es Gen-Editing-Technologien einsetzt, um die Sicherheit und Wirksamkeit von CAR-T-Zellbehandlungen zu verbessern. Allerdings erfordert ihre Methode immer noch die Verwendung der eigenen T-Zellen des Patienten, was den Prozess kostspielig und langwierig macht. 2seventy Bio hingegen hat eine proprietäre Dimerizing Agent Regulated Immunoreceptor Complex (DARIC) T-Zell-Plattform entwickelt, die die Herstellung von Standard-Zelltherapien ermöglicht, die für Patienten sofort verfügbar sind.
Bewertung"

Das mancher Artikel da auch eher mäßig originell ist, merkt man daran, das Celgen bereits übernommen wurde. Und zwar durch Bristol Myers Squibb.

Wie hieß noch gleich der aktuelle Partner von 2seventy Bio?

"Kommerzielle Zusammenfassung von Abecma
Unser Partner Bristol Myers Squibb (BMS) meldete für Abecma (idecabtagene vicleucel; ide-cel) im vierten Quartal in den USA einen Gesamtumsatz von 94 Mio. US-Dollar, was einem Wachstum von 25 % gegenüber dem Vorquartal und 40 % gegenüber dem vierten Quartal 2021 entspricht, sowie einen Gesamtjahresumsatz von 297 Mio. US-Dollar, was unserer für 2022 abgegebenen Umsatzprognose für Abecma in den USA von 250 bis 300 Mio. US-Dollar entspricht, wobei dieser Umsatz in jedem Fall zu gleichen Teilen mit BMS geteilt wird. Unter der Annahme einer anhaltend starken Nachfrage nach Abecma und der Erreichung der geplanten Erhöhung der Produktionskapazitäten im Laufe des Jahres erwarten wir für 2023 einen Gesamtumsatz in den USA von 470-570 Millionen US-Dollar."

Bristol Myers Squibb.
Da muss man jetzt kein Genie sein, um 1 und 1 zusammen zu zählen.
Ich hab schon deutlich schlechtere Thesen für eine Übernahme gelesen. :D

ir.2seventybio.com/news-releases/...r-financial-results-and-0
2seventy bio Reports First Quarter Financial Results and Recent Operational Progress
May 3, 2023 at 4:05 PM EDT

Abecma (idecabtagene vicleucel) generated $118 million U.S. commercial revenue in 1Q 2023, supporting upper end of U.S. revenue guidance of $470-570 million

U.S. FDA accepted supplemental Biologics License Application (sBLA) based on results from the pivotal phase 3 KarMMa-3 study of Abecma; PDUFA date December 16, 2023

Collaboration with Novo Nordisk delivers proof of concept data for in-vivo gene editing hemophilia A program; triggers $15 million milestone payment from Novo Nordisk

Ended quarter with $341.4 million cash, cash equivalents, and marketable securities; maintaining cash runway into 2026

Company to host virtual Research and Development Deep Dive session on May 19, 2023..."

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"Seventy Bio: EPS übertrifft Schätzungen um 0,24$ - Umsatz besser als erwartet
Veröffentlicht am 04.05.2023 00:06
TSVT
+14,53%
Investing.com - 2Seventy Bio (NASDAQ: TSVT) hat im ersten Quartal ein EPS von -1,08$ gemeldet, 0,24$ mehr als die Analystenschätzung von -1,32$.

Der Umsatz für das abgelaufene Vierteljahr belief sich auf 41,62M$, die durchschnittlichen Schätzungen hatten sich auf 20,34M$ belaufen..."
de.investing.com/news/...--umsatz-besser-als-erwartet-2398298
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