WORCESTER, Mass. - Mustang Bio , Inc. (NASDAQ:MBIO), a clinical-stage biopharmaceutical company, has announced positive results from its Phase 1/2 clinical trial of MB-106, a CD20-targeted CAR T-cell therapy for Waldenstrom macroglobulinemia (WM), a rare blood cancer.
The data, presented at the European Hematology Association 2024 Hybrid Congress, showed a 90% response rate among participants, with one patient in complete remission for 31 months.
All ten patients in the study had previously been treated with Bruton's tyrosine kinase inhibitors (BTKi) without success. Following treatment with MB-106, nine patients responded positively, including three complete responses, two very good partial responses, and four partial responses. Additionally, one patient experienced stable disease.
Safety outcomes were also favorable, with cytokine release syndrome (CRS) occurring in nine patients, all of which were grade 1 or 2 in severity. Only one patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), with no higher-grade CRS or ICANS observed.
Dr. Brian Till, Associate Professor at Fred Hutch and University of Washington, expressed optimism about the safety and efficacy data, highlighting the quality of responses and the potential for MB-106 CAR T-cell expansion and persistence.
The trial was conducted in collaboration with Fred Hutch Cancer Center, where scientists may benefit financially from the development of these therapies. Mustang Bio's continued development of MB-106 for hematologic malignancies depends on securing additional funding or establishing strategic partnerships.
This press release statement, which contains forward-looking statements, notes the necessity of substantial additional funds and the uncertainties inherent in product development and regulatory approvals. It is based on the information provided by Mustang Bio, Inc. and does not endorse the company's claims or imply the future success of the therapy.
In other recent news, Fortress Biotech (NASDAQ:FBIO) has seen its stock target significantly increased by H.C. Wainwright from $10.00 to $24.00, reflecting an optimistic outlook for the biopharmaceutical company. The firm anticipates significant regulatory milestones for Fortress's partners and aims to address the perceived undervaluation of the company's stock.
The company's financial strength is bolstered by valuable equity stakes in several partner companies and is expected to benefit from substantial milestone payments, including potential revenue sharing from Priority Review Vouchers (PRVs), as well as anticipated royalties from multiple assets.
On the other hand, Roth/MKM maintained a Buy rating on Fortress Biotech stock, highlighting the company's 2023 revenue of $84.5 million, an increase from the $75.7 million reported in 2022.
The firm also disclosed several key milestones anticipated for 2024, including the submission of DFD-29 for rosacea treatment by Journey Medical and the BLA submission for Cosibelimab, a treatment for cSCC by Checkpoint Therapeutics (NASDAQ:CKPT).
Despite a downward revision of the revenue outlook for 2024 to $88.9 million from the previously projected $98.6 million, the analyst anticipates a significant revenue increase in 2025, driven by contributions from Journey Medical's DFD-29 and Checkpoint Therapeutics' Cosibelimab. These developments and milestones are expected to potentially push Fortress Biotech's consolidated profit and loss cash flow into positive territory by 2026/2027.
InvestingPro Insights
Amidst the promising clinical trial results for Mustang Bio's MB-106 therapy, a deeper look into the financial health of the company through InvestingPro reveals a mixed picture. With a market capitalization of just $37.24 million, Mustang Bio is a relatively small player in the biopharmaceutical industry. This small size could impact its ability to secure the substantial additional funding mentioned in their press release.
InvestingPro data shows that Mustang Bio has experienced a significant price decline over the past year, with a 1 Year Price Total Return of -82.44%. This could suggest investor skepticism about the company's prospects or broader market trends affecting biotech stocks. Despite this, the company's revenue has grown by 32.48% over the last twelve months as of Q1 2024, indicating some operational progress.
Two InvestingPro Tips that stand out for Mustang Bio are the expected net income growth this year and the company's quick cash burn. These conflicting signals highlight the company's potential to reach profitability, as anticipated by analysts, while also underscoring the need for careful cash management and the importance of securing additional capital for continued development.
For investors interested in a more comprehensive analysis, there are additional InvestingPro Tips available, offering insights into Mustang Bio's financial performance, including valuation multiples and profitability metrics. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable tips and make more informed investment decisions.
Overall, while the clinical advancements of MB-106 are indeed promising, potential investors should consider the financial stability and growth prospects of Mustang Bio, as highlighted by the InvestingPro platform.
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