Idiopathic Inflammatory Myopathies

ADI-001 clinical development program now addresses six autoimmune diseases Patient enrollment for idiopathic inflammatory myopathy and stiff person syndrome cohort expected to be initiated in the first quarter of 2025 Company plans to report initial clinical data from Phase 1 study in multiple autoimmune diseases in the first half of 2025 REDWOOD CITY, CA & BOSTON, MA, USA I October 16, 2024 I Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to the Company’s Investigational New Drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of the ongoing Phase 1 trial in autoimmune diseases. The Company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the Company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis (LN), including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). “The FDA’s acceptance of our IND amendment to evaluate ADI-001 in patients with IIM and SPS builds on our recent momentum in autoimmune diseases, expanding our efforts to six autoimmune indications as we aim to bring our differentiated gamma delta T cell therapy candidates to more patients in need of new treatment options,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “Following our recent announcement highlighting clinical biomarker data which demonstrated robust B-cell depletion and preferential trafficking to tissues and organs, we believe in ADI-001’s best-in-class potential for the treatment of autoimmune diseases, and we look forward to initiating patient enrollment in IIM and SPS in the first quarter of 2025 in our ongoing Phase 1 clinical program.” The ADI-001 Phase 1 program in autoimmune diseases will have four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, AAV patients into a third arm, and IIM and SPS patients into a fourth arm. The fourth cohort combines several rare autoimmune muscle diseases into a single dose-finding population, including SPS and the following IIM subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18, and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication. About Idiopathic Inflammatory Myopathy Idiopathic inflammatory myopathy (IIM, or myositis) refers to a group of rare autoimmune disorders characterized by chronic muscle inflammation and progressive muscle weakness. IIM primarily affects skeletal muscles but can also involve other organs such as the lungs, heart, and skin. Five of the main subtypes include dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis, all of which can lead to significant functional impairment and have the potential to be life threatening. There is no available cure for IIM and many patients on current treatments have refractory disease and may experience significant side effects. About Stiff Person Syndrome Stiff person syndrome (SPS) is a rare neurological autoimmune disorder characterized by severe muscle stiffness and spasms, primarily affecting the torso and limbs. Muscle stiffness caused by SPS often impairs mobility, making it difficult for patients to walk, bend, or perform daily activities. Muscle spasms can be triggered by sudden stimuli such as loud noises, physical contact, or emotional distress, and can result in a “statue-like” posture when severe. Due to its rarity and overlapping symptoms with other conditions, SPS is frequently misdiagnosed, often as an anxiety disorder or movement disorder. There is currently no available cure for SPS. About ADI-001 ADI-001 is aninvestigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 was granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), and the ongoing Phase 1 study is also evaluating ADI-001 for the treatment of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS). In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in peripheral blood and secondary lymphoid tissue. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com . SOURCE: Adicet Bio

PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. The presentations will feature new and updated clinical data on CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, which is being evaluated in multiple ongoing clinical trials in the RESET™ clinical development program. Details of the presentations are as follows: Oral Presentation: Title: Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical TrialsAbstract ID: 1857177Date and Time: Sunday, November 17, 2024, 3:30 p.m. – 3:45 p.m. ETPresenter: David J. Chang, M.D., M.P.H, FACR, Chief Medical Officer, Cabaletta Bio Poster Presentation: Title: Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical TrialsAbstract ID: 1866605Date and Time: Saturday, November 16, 2024, 10:30 a.m. – 12:30 p.m. ETPresenter: Daniel Nunez, Ph.D., Director, Computational Biology at Cabaletta Bio Additional information, including the accepted abstracts, can be accessed on the ACR Convergence 2024 website. Presentation materials will be made available on the Posters & Publications section of the Company’s website following the event. About CABA-201CABA-201 is designed to deeply and transiently deplete CD19-positive cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions within five disease-specific company sponsored INDs including myositis (idiopathic inflammatory myopathy, or IIM), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), generalized myasthenia gravis (gMG), and pemphigus vulgaris (PV; a sub-study to evaluate CABA-201 without preconditioning). About Cabaletta BioCabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in myositis, systemic lupus erythematosus, systemic sclerosis, generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Contacts: Anup MardaChief Financial Officerinvestors@cabalettabio.com William GramigPrecision AQ william.gramig@precisionaq.com

– Enrollment complete in aplitabart randomized colorectal cancer clinical trial; top-line PFS results expected by the end of 1Q25 – – Second dose cohort cleared in imvotamab rheumatoid arthritis clinical trial – – First dose cohort cleared in imvotamab systemic lupus erythematosus clinical trial – MOUNTAIN VIEW, Calif., Aug. 14, 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 fiscal quarter ended June 30, 2024 and provided an update on recent developments. “We continue to make significant progress in the clinical development of our two lead product candidates,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We are pleased to have completed enrollment of 127 patients in our randomized study of 3mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer. We are also pleased to have successfully cleared the first two cohorts of our clinical trial of imvotamab in severe rheumatoid arthritis as well as the first cohort of our clinical trial of imvotamab in severe systemic lupus erythematosus.” Pipeline Updates Aplitabart (death receptor 5 agonist) Clinical development of aplitabart advances. Enrollment completed in randomized colorectal cancer clinical trial. The Company announced that it has completed enrollment in its randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. A total of 127 patients, exceeding the trial design target of 110 patients, were enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will depend on the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025. Imvotamab (CD20 x CD3 T cell engager) Clinical development of imvotamab in autoimmune diseases advances. First and second dose cohorts in rheumatoid arthritis successfully completed. The Company announced that it has cleared both the first and second dose cohorts of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis and is currently enrolling the third cohort. This study is designed to evaluate three cohorts of progressively higher dose regimens of imvotamab, with each cohort designed to recruit eight patients, six of whom receive imvotamab and two of whom receive placebo.First dose cohort in systemic lupus erythematosus successfully completed. The Company announced that it has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE), with each dose cohort designed to recruit six patients, all of whom are to be treated with imvotamab. The Company is currently enrolling patients in a second dose cohort and plans to enroll a third dose cohort, with each cohort at progressively higher dose regimens of imvotamab.Enrollment initiated in myositis. The Company has initiated recruitment of patients in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). IGM-2644 (CD38 x CD3 T cell engager) Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company has made significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. The Company currently expects to begin enrolling patients in a single arm, open-label clinical study testing IGM-2644 in generalized myasthenia gravis (gMG) by the end of 2024. Second Quarter 2024 Financial Results Cash and Investments: Cash and investments as of June 30, 2024 were $256.4 million, compared to $337.7 million as of December 31, 2023.Collaboration Revenue: For the second quarter of 2024, collaboration revenues were $1.3 million compared to $0.4 million for the second quarter of 2023.Research and Development (R&D) Expenses: For the second quarter of 2024, R&D expenses were $42.0 million, compared to $55.7 million for the second quarter of 2023.General and Administrative (G&A) Expenses: For the second quarter of 2024, G&A expenses were $10.6 million, compared to $13.0 million for the second quarter of 2023.Net Loss: For the second quarter of 2024, net loss was $47.9 million, or a loss of $0.79 per share, compared to a net loss of $64.4 million, or a loss of $1.43 per share, for the second quarter of 2023. 2024 Financial Guidance The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026. About IGM Biosciences, Inc.IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against immunology and inflammation targets. For more information, please visit www.igmbio.com. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including with respect to patient enrollment, dosing, and the timing of the release of data; IGM’s expectations regarding its financial position and results, including its stock-based compensation expense and collaboration revenue, and projected cash runway; and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM's ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM's ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; uncertainties related to IGM's ability to realize the contemplated benefits of its pipeline prioritization efforts and related reduction in force; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law. Contact: Argot Partners David Pitts 212-600-1902 igmbio@argotpartners.com IGM Biosciences, Inc.Selected Statement of Operations Data(unaudited)(in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Collaboration revenue $1,254 $448 $1,751 $970 Operating expenses: Research and development (1) 41,962 55,673 85,777 106,567 General and administrative (1) 10,649 12,983 21,187 25,985 Total operating expenses 52,611 68,656 106,964 132,552 Loss from operations (51,357) (68,208) (105,213) (131,582) Other income (expense): Interest income 3,455 3,894 7,495 8,066 Other expense — — — (20)Total other income (expense) 3,455 3,894 7,495 8,046 Loss before income tax expense (47,902) (64,314) (97,718) (123,536)Income tax expense — (109) — (196)Net loss $(47,902) $(64,423) $(97,718) $(123,732) Net loss per share, basic and diluted $(0.79) $(1.43) $(1.62) $(2.76)Weighted-average common shares outstanding, basic and diluted 60,434,161 45,122,900 60,274,285 44,796,644 (1) Amounts include stock-based compensation expense as follows: Research and development $4,807 $8,248 $9,169 $14,687 General and administrative 3,621 6,061 7,181 10,669 Total stock-based compensation expense $8,428 $14,309 $16,350 $25,356 IGM Biosciences, Inc. Selected Balance Sheet Data (unaudited)(in thousands) June 30, December 31, 2024 2023 Cash and investments $256,381 $337,677 Total assets 336,501 423,411 Accounts payable 3,259 1,326 Accrued liabilities 26,461 31,544 Deferred revenue 145,050 146,801 Total liabilities 214,143 220,177 Accumulated deficit (918,960) (821,242)Total stockholders' equity 122,358 203,234