SLE

IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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星期四, 三月 7, 2024

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.
  • Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively.
  • Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively.
  • General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively.

Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

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星期四, 三月 7, 2024

GAITHERSBURG, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2023, and recent corporate updates.

Key Points: 
  • Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024.
  • Announced Positive Long-Term Follow-Up Data from Phase 2a Study of Descartes-08 in Patients with MG.
  • In January 2024, Cartesian announced that the FDA cleared its IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T product candidate.
  • General and administrative expenses were $40.6 million for the year ended December 31, 2023, compared to $23.9 million for the year ended December 31, 2022.

Alumis Announces Upsized $259M Series C Financing to Advance Clinical-stage Pipeline of Oral Therapies Designed to Address Immune Dysfunction

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星期三, 三月 6, 2024

SOUTH SAN FRANCISCO, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced an upsized $259M Series C financing. Alumis plans to use the proceeds of the financing to initiate pivotal Phase 3 clinical trials for its lead candidate ESK-001, a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate to severe plaque psoriasis in the second half of 2024, as well as support the two ongoing Phase 2 clinical trials for ESK-001 in systemic lupus erythematosus (SLE), and non-infectious uveitis. The financing will also support the further advancement of Alumis’ precision data analytics and multi-platform approach to explore ESK-001’s potential application in other autoimmune indications, as well as A-005, a TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases, and its earlier-stage internal pipeline programs.

Key Points: 
  • Srinivas Akkaraju, M.D., Ph.D., Founder and Managing General Partner of Samsara BioCapital, and Richard Gaster, M.D., Ph.D., Managing Partner at venBio Partners, will join Alumis’ Board of Directors.
  • “This investment will support the continued clinical development of ESK-001, building on promising data that have demonstrated full, sustained target inhibition leading to a potentially best-in-class oral TYK2 inhibitor profile.
  • We are now starting to see how this will translate into outcomes for patients.
  • We are proud of the company’s progress and happy to continue to support and work with the Alumis team and Board of Directors in this next stage of the company’s growth.”

Super League Announces Sale of Minehut Business Unit to GamerSafer

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星期四, 二月 29, 2024

The Board of Directors of both Super League and GamerSafer have approved the transaction, which is now complete.

Key Points: 
  • The Board of Directors of both Super League and GamerSafer have approved the transaction, which is now complete.
  • The two companies will maintain a commercial relationship which ensures that Minehut can remain an ongoing destination available to Super League’s partners.
  • “We are pleased with the sale of the Minehut business to GamerSafer, a company committed to growing the business globally,” said Super League Chair and CEO Ann Hand.
  • Minehut, powered by GamerSafer safety tech and partnering with Super League, brings even more value to the community and brands,” said GamerSafer Co-founder and CEO, Rodrigo Tamellini.

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

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星期一, 二月 26, 2024

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Total Operating Expenses: For the fourth quarter of 2023, GAAP operating expenses were $49.8 million, including research and development expenses of $31.8 million and general and administrative expenses of $17.9 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of December 31, 2023.
  • ET to review financial and operating results for the quarter and full year ended December 31, 2023.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Galapagos announces full year 2023 results and outlook for 2024

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星期四, 二月 22, 2024

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

CRISPR Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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星期三, 二月 21, 2024

R&D Expenses: R&D expenses were $95.1 million for the fourth quarter of 2023, compared to $103.6 million for the fourth quarter of 2022.

Key Points: 
  • R&D Expenses: R&D expenses were $95.1 million for the fourth quarter of 2023, compared to $103.6 million for the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses were $16.5 million for the fourth quarter of 2023, compared to $21.2 million for the fourth quarter of 2022.
  • Collaboration Expense: Collaboration expense, net, was $20.0 million for the fourth quarter of 2023, compared to $6.8 million for the fourth quarter of 2022.
  • Net Income (Loss): Net income was $89.3 million for the fourth quarter of 2023, compared to a net loss of $110.6 million for the fourth quarter of 2022.

Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy

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星期四, 二月 29, 2024

We are eager to address the significant unmet need in lupus nephritis as we initiate our Phase 1 trial,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • We are eager to address the significant unmet need in lupus nephritis as we initiate our Phase 1 trial,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • “CAR T cells can naturally infiltrate deep into target tissues to mediate B-cell depletion and produce durable responses.
  • The ATA3219 IND submission included in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients.

Lupus Research Alliance Announces Recipients of the Lupus Mechanisms and Targets Award

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星期三, 二月 28, 2024

NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).

Key Points: 
  • NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).
  • The development of targeted treatments is hindered by an incomplete understanding of lupus and its devastating complications.
  • These seven talented investigators will identify targets for new treatments and test novel therapeutic avenues to revolutionize the field and improve the lives of individuals with lupus.
  • Surgical biopsies of the kidneys are often needed to diagnose lupus nephritis (LN), kidney inflammation caused by lupus that can result in severe and sometimes life-threatening organ damage.

Atara Biotherapeutics Announces Submission of Investigational New Drug Application for ATA3219 for Treatment of Lupus Nephritis

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星期三, 二月 14, 2024

“We are dedicated to advancing medical breakthroughs with innovative cell therapies that truly make a difference.

Key Points: 
  • “We are dedicated to advancing medical breakthroughs with innovative cell therapies that truly make a difference.
  • Treatment will be facilitated for patients and physicians in avoiding apheresis and lengthy patient-by-patient manufacturing as ATA3219 would be rapidly available as an off-the-shelf treatment from finished product inventory.
  • The ATA3219 IND submission includes robust in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients.
  • Despite recent advances in treatment strategies, the response rate using existing therapies remains low, with significant risk of long-term morbidity and mortality associated with refractory LN.