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Generation Bio Announces Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-07 20:05
CAMBRIDGE, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO), a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases, today announced that, on July 1, 2025, the company granted equity awards to one new employee, pursuant to the company’s 2025 Inducement Stock Incentive Plan, as an inducement material to such new employee’s entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). The employ ...
Sana Biotechnology (SANA) Earnings Call Presentation
2025-07-04 09:46
Type 1 Diabetes (T1D) Program - Sana's hypoimmune platform (HIP) overcomes allogeneic rejection in people, which is confirmed by 4-week and 12-week data[4] - Type 1 diabetes affects 94 million children and adults, and is projected to affect 164 million by 2040[12, 13] - Type 1 diabetes leads to 201600 deaths per year and costs $81 billion worldwide annually[17] - SC451, a HIP-modified stem cell-derived pancreatic islet therapy, is advancing toward the clinic with an expected IND filing as early as 2026[114] - HIP-modified PSC differentiated islet cells transplanted into muscle persist & control blood glucose in mice for >15 months[64] Autoimmune Disease Program - B-cell mediated autoimmune diseases affect >5 million patients[68] - SC291, a HIP-modified CD19 CAR T, leads to deep B-cell depletion and has significant potential in B-cell mediated autoimmune diseases, with an ongoing GLEAM study[114] - Sana's T cell manufacturing process provides ~85% full knock-out of MHC class I and II, >995% TCR negative cells[79] - Fusogen platform offers the potential to treat B-cell mediated autoimmune diseases and B-cell cancers with NO lymphodepletion with an expected IND filing as early as 2026[114] Oncology Program - SC262, a HIP-modified CD22 CAR T, has meaningful potential in treating CD19 CAR T relapsed patients, with an ongoing VIVID study[114] - Estimated ~12000 B cell malignancy patients treated with CD19 CAR T in 2027, with ~35-40% durable complete responses, leading to ~7500 CAR T failures annually[106]
Vor Bio Stock Skyrockets 250% in the Past Week: Here's Why
ZACKS· 2025-06-30 15:41
Core Insights - Vor Bio's shares have surged by 265.5% in the past week, significantly outperforming the industry average increase of 0.8% [1] - The company has entered a licensing agreement with RemeGen to develop and commercialize telitacicept in markets outside of China [1][6] Licensing Agreement Details - The licensing deal is valued at $125 million upfront, which includes $45 million in cash and $80 million in stock warrants, along with potential milestone payments exceeding $4 billion and tiered royalties on future sales [6][7] - Vor Bio will focus on developing telitacicept, a dual-target fusion protein that blocks two proteins, BAFF and APRIL, to treat autoimmune diseases [2][7] Clinical Development - A global phase III study for telitacicept in treating generalized myasthenia gravis (gMG) is currently ongoing in the United States, Europe, and South America, with initial data expected in the first half of 2027 [3] Leadership Changes - Vor Bio has appointed Jean-Paul Kress as the new CEO and chairman, following the resignation of the previous CEO, Robert Ang [3][6] Company Outlook - The licensing agreement is seen as a pivotal move that may prevent Vor Bio from shutting down its operations, which was previously announced due to financial difficulties [8]
Forte Biosciences (FBRX) Earnings Call Presentation
2025-06-23 12:34
FORTE BIOSCIENCES CLINICAL STAGE FB-102 3 FB102 CELIAC DISEASE PHASE 1B RESULTS JUNE 2025 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, ...
Cullinan Therapeutics (CGEM) Earnings Call Presentation
2025-06-05 08:10
Cullinan Therapeutics Licensing of velinotamig (BCMAxCD3) from Genrix Bio June 2025 © CULLINAN THERAPEUTICS, INC. ALL RIGHTS RESERVED. CONFIDENTIAL AND PROPRIETARY Important Notice and Disclaimers This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding the potential benefits of, and pl ...
Cullinan Therapeutics (CGEM) 2025 Conference Transcript
2025-06-04 17:50
Summary of the Conference Call on Cell Therapy and Autoimmune Diseases Industry Overview - The discussion focuses on the emerging field of cell therapy, particularly T cell engagers and CAR T therapies, and their applications in treating autoimmune diseases alongside oncology applications [1][2]. Key Companies and Their Innovations Cullinan - Cullinan is exploring T cell engagers to redirect T cells for depleting aberrant immune cells, particularly B cells, in autoimmune diseases [3]. - The company aims to make T cell redirecting therapies accessible in community-based centers, enhancing patient access [3]. Autolus - Autolus has launched a CD19 CAR T product approved for acute leukemia, demonstrating a strong safety profile and exceptional activity, leading to long-term remissions in advanced disease patients [4][5]. - The company is also looking to expand into the autoimmune space, believing that their product's features will be beneficial [6]. Caballetta - Caballetta focuses on developing cellular therapies specifically for autoimmune diseases, with their lead product ResiCel entering phase three trials for myositis [9][10]. - The company has agreements with the FDA for multiple cohorts in various trials, targeting diseases like lupus and multiple sclerosis [11]. Core Insights and Arguments - The panelists agree on the significant unmet need in autoimmune diseases and the potential for their therapies to provide meaningful clinical advances [8]. - T cell engagers have shown promise in achieving disease-modifying benefits, with reports indicating deep B cell depletion and symptom improvement in treated patients [14][15]. - The safety profile of these therapies is emphasized as a key differentiator in a market with high unmet needs [11][12]. Clinical Development and Regulatory Pathways - The discussion highlights the importance of understanding patient subtypes and tailoring treatment strategies based on disease severity and pathology [41]. - There is a consensus that the regulatory path for T cell engagers may differ from traditional drug approvals, with a focus on therapeutic benefit and safety [63][64]. Market Dynamics and Future Outlook - The panelists predict a competitive landscape in the autoimmune therapy market, with multiple modalities coexisting rather than competing fiercely [13]. - The potential for bispecific therapies to transform treatment paradigms is acknowledged, with expectations for improved efficacy and safety profiles [32][38]. - The market for autoimmune therapies is seen as distinct from oncology, with different pricing and patient demographics influencing market strategies [30][31]. Additional Considerations - The importance of biomarkers in identifying suitable patients for different therapies is highlighted, with ongoing research expected to refine patient selection [25][41]. - The need for collaboration between hematologists and rheumatologists is emphasized to facilitate patient enrollment in clinical trials [58][61]. This summary encapsulates the key points discussed during the conference call, providing insights into the current state and future potential of cell therapies in treating autoimmune diseases.
Jade Biosciences to Present New Preclinical Data on JADE101 at the 62nd European Renal Association Congress
Globenewswire· 2025-06-02 11:00
Company to host conference call and webcast on June 9, 2025, at 8:00 a.m. ETSAN FRANCISCO and VANCOUVER, British Columbia, June 02, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (“Jade”) (Nasdaq: JBIO), a biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced new preclinical data on JADE101, its anti-APRIL monoclonal antibody being developed for the treatment of IgA nephropathy (IgAN), will be presented in an oral session during the 62nd European Renal ...
Generation Bio to Present at the 2025 Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 10:59
Core Insights - Generation Bio Co. is focused on developing innovative therapeutics for T cell-driven autoimmune diseases [3] - The company will present at the Jefferies Global Healthcare Conference on June 4, 2025 [1] - A live webcast of the presentation will be available on the company's investor website [2] Company Overview - Generation Bio is developing redosable therapeutics that aim to reprogram T cells in vivo to combat autoimmune diseases [3] - The company utilizes cell-targeted lipid nanoparticles (ctLNP) for selective delivery of small interfering RNA (siRNA) to T cells [3] - This approach targets historically undruggable genes associated with autoimmune diseases, potentially unlocking new treatment avenues [3]
Zenas BioPharma, Inc.(ZBIO) - 2025 Q1 - Earnings Call Presentation
2025-05-15 12:55
Zenas BioPharma Enabling patients with autoimmune diseases to reimagine life Corporate Presentation May 2025 1 Disclaimer FORWARD-LOOKING STATEMENTS: This presentation contains "forward-looking statements" which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts cont ...
Jade Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-14 20:05
Completed reverse merger and commenced trading on Nasdaq as JBIO Closed financing, raising approximately $300 million to date, providing cash runway through 2027 Lead candidate JADE101 expected to enter the clinic in second half of 2025, with interim biomarker-rich data expected in first half of 2026 SAN FRANCISCO and VANCOUVER, British Columbia, May 14, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (“Jade”) (Nasdaq: JBIO), a biotechnology company focused on developing best-in-class therapies for autoimmu ...