PHILADELPHIA, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026, at 9:30 a.m. ET in New York, NY. A live webcast of the presentation will be available o ...

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Core Viewpoint - The article expresses a cautious optimism regarding Cabaletta Bio (CABA) as it progresses with its engineered cell therapy through clinical trials in the biotech sector [1]. Group 1: Company Overview - Cabaletta Bio is focused on developing engineered cell therapies, indicating a commitment to innovation in the biotech field [1]. Group 2: Analyst Background - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, which adds credibility to the insights provided [1].

Group 1 - Cabaletta Bio, Inc. (CABA) is outperforming the Medical sector with a year-to-date return of 34.7%, compared to the sector's average return of 8.1% [4] - The Zacks Consensus Estimate for CABA's full-year earnings has increased by 4.6% over the past quarter, indicating improved analyst sentiment [4] - Cabaletta Bio, Inc. holds a Zacks Rank of 2 (Buy), suggesting it is positioned to outperform the broader market in the near term [3] Group 2 - Cabaletta Bio, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 452 stocks and has an average return of 21.6% this year [6] - Celcuity, Inc. (CELC) is another stock in the Medical sector that has shown strong performance, with a year-to-date return of 14.3% and a Zacks Rank of 2 (Buy) [5] - Investors should closely monitor both Cabaletta Bio, Inc. and Celcuity, Inc. for potential continued strong performance in the Medical sector [7]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - iOThree Limited (IOTR) has increased by 177% to $8.12 - 60 Degrees Pharmaceuticals, Inc. (SXTP) has risen by 90% to $3.81 - Greenwich LifeSciences, Inc. (GLSI) is up 52% at $33.98 - Erayak Power Solution Group Inc. (RAYA) has gained 30% to $3.12 - High Roller Technologies, Inc. (ROLR) is up 24% at $9.87 - Cabaletta Bio, Inc. (CABA) has increased by 12% to $2.63 - Nvni Group Limited (NVNI) is up 10% at $3.23 - Karman Holdings Inc. (KRMN) has risen by 9% to $114.79 - Venture Global, Inc. (VG) is up 9% at $9.87 - Oportun Financial Corporation (OPRT) has increased by 9% to $5.32 [3] Premarket Losers - Yunhong Green CTI Ltd. (YHGJ) has decreased by 11% to $4.20 - GlucoTrack, Inc. (GCTK) is down 11% at $3.45 - Black Titan Corporation (BTTC) has fallen by 11% to $2.08 - Lee Enterprises, Incorporated (LEE) is down 10% at $5.02 - Namib Minerals (NAMM) has decreased by 10% to $2.02 - Top Wealth Group Holding Limited (TWG) is down 7% at $4.10 - Axogen, Inc. (AXGN) has fallen by 6% to $30.86 - iPower Inc. (IPW) is down 6% at $4.60 - Masonglory Limited (MSGY) has decreased by 5% to $5.11 - Bonk, Inc. (BNKK) is down 5% at $4.56 [4]

Core Insights - Biotech and healthcare sectors experienced notable movements in after-hours trading, particularly among small-cap companies, with several posting significant gains [1] Company Summaries - IO Biotech, Inc. (IOBT) saw a surge of 19.36% to $0.25 after announcing plans to explore various strategic alternatives to maximize stockholder value, including potential mergers, asset sales, or liquidation. The company is also considering further reductions in workforce and operational costs [2] - Cue Biopharma, Inc. (CUE) advanced 10.67% to $0.42, with gains attributed to speculative trading despite no specific news from the company [3] - InfuSystem Holdings, Inc. (INFU) climbed 7.19% to $9.24, continuing a trend of strength in the medical services sector without any new corporate updates [3] - Cabaletta Bio, Inc. (CABA) added 7.68% to $2.52, with investors likely reacting to the company's January 12 update on its 2026 strategic priorities, including plans for the development of rese-cel and advancements in automated manufacturing [4] - Iterum Therapeutics plc (ITRM) gained 3.60% to $0.3284, driven by modest buying interest despite the absence of fresh news [5] - BioCardia, Inc. (BCDA) rose 3.91% to $1.33, attracting buyers in after-hours trading without any new updates [5]

Core Insights - Cabaletta Bio is focused on advancing its investigational CAR T cell therapy, rese-cel, for autoimmune diseases, with a pivotal myositis trial actively enrolling and a planned Biologics License Application (BLA) submission in 2027 [1][2] Group 1: Strategic Priorities and Clinical Development - The company aims to translate registrational pathways for rese-cel into a product pipeline across various autoimmune diseases, with a specific focus on enrolling a 17-patient cohort for the myositis trial [3] - The FDA has aligned with Cabaletta on the design of registrational cohorts for systemic lupus erythematosus (SLE) and lupus nephritis (LN), evaluating a weight-based dose of 1 million cells/kg [3][4] - Cabaletta has received Regenerative Medicine Advanced Therapy (RMAT) designation for rese-cel in systemic sclerosis and is working on aligning registrational cohort designs for additional conditions [4] Group 2: Manufacturing and Scalability - The company has obtained clearance for an Investigational New Drug (IND) amendment to manufacture rese-cel using the Cellares platform, which is expected to enhance scalability and reduce costs [5] - Clinical manufacturing data is anticipated in the first half of 2026 to confirm Good Manufacturing Practice (GMP) readiness and supply chain logistics for Cellares-produced rese-cel [5] Group 3: Clinical Data and Innovations - New durability data from ongoing trials without preconditioning and higher dose initial clinical data from RESET-PV™ are expected in the first half of 2026 [1][8] - Complete Phase 1/2 data from trials in lupus, scleroderma, and myasthenia gravis are anticipated in the first half of 2026, which will provide insights into the therapy's efficacy [1][8] Group 4: Company Overview - Cabaletta Bio is a late-stage clinical biotechnology company dedicated to developing targeted cell therapies for autoimmune diseases, with its lead therapy, rese-cel, being evaluated in multiple ongoing trials [9]

Core Insights - Cabaletta Bio is focused on developing and commercializing rese-cel, a product aimed at redefining the treatment of autoimmune diseases [3]. Company Overview - The company was founded with the intention of replicating successful academic studies conducted by Professor Schett, which demonstrated promising results in treating autoimmune diseases [3]. - The design of rese-cel closely mirrors the product used in academic studies, with dosing adjusted based on weight to align with clinical data [3]. Development Timeline - The timeline for the development of rese-cel includes an IND filing in 2023, with expectations to address multiple diseases by the end of 2025 [4].

Financial Data and Key Metrics Changes - The company is on track to file a Biologics License Application (BLA) in 2027 and plans to launch CABA-201 in 2027 or 2028, indicating a significant upcoming milestone for the company [69][70] - The company has reported a very low out-of-spec rate of less than 1% for the manufacturing of CABA-201, which is a significant improvement compared to historical CAR-T therapies [22][20] Business Line Data and Key Metrics Changes - The RESET clinical development program for CABA-201 has multiple diseases fully enrolled, with some completing the phase 1/2 portion, showcasing progress in the development pipeline [5][6] - The myositis pivotal trial is set to initiate enrollment imminently, with alignment from the FDA on the protocol, indicating readiness for the next phase of clinical trials [10][11] Market Data and Key Metrics Changes - The company aims to leverage outpatient therapy for CABA-201, which is expected to provide a more favorable financial profile compared to traditional inpatient CAR-T therapies [11][35] - The company plans to launch through Contract Development and Manufacturing Organizations (CDMOs) to ensure supply and avoid constraints at launch, which is a strategic move to meet market demand [32][33] Company Strategy and Development Direction - The company is focused on outpatient therapy for autoimmune diseases, which is expected to transform the treatment landscape and provide a compelling value proposition compared to existing therapies [11][36] - The partnership with Cellares for fully automated manufacturing is expected to enhance scalability and efficiency, allowing the company to support a large patient population without the need for extensive infrastructure [62][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of CABA-201, with a lower incidence of cytokine release syndrome (CRS) compared to oncology CAR-T therapies, which is crucial for outpatient administration [13][27] - The company anticipates that the outpatient model will not only improve patient outcomes but also create a financially sustainable CAR-T infusion center, addressing historical challenges in the CAR-T market [36][70] Other Important Information - The company has a strong clinical footprint with 77 sites planned for the launch of CABA-201, which is larger than any other company in the space, indicating a robust strategy for market entry [57][61] - The company is actively engaging with payers to discuss pricing strategies that reflect the value delivered by CABA-201, which is expected to be competitive against existing therapies in the autoimmune space [41][59] Q&A Session Summary Question: How does the safety profile of CABA-201 compare to other CAR-T therapies? - The company reported that approximately one-third of patients developed CRS, mostly grade 1, which is significantly lower than other autologous CAR-T therapies [13] Question: What is the plan for outpatient dosing? - Management indicated that outpatient therapy is a key component of their strategy, with the FDA's recent review supporting this approach [26][28] Question: Are there any concerns regarding manufacturing capacity? - The company is confident in its manufacturing strategy, utilizing CDMOs to ensure supply and avoid constraints at launch, which is a proactive measure to meet anticipated demand [32][33] Question: How does the company plan to compete against larger pharma competitors? - The company believes it can successfully compete due to its extensive clinical footprint and the unique value proposition of CABA-201, which is expected to deliver better outcomes at a sustainable cost [57][58]

Financial Data and Key Metrics Changes - The company has seen significant progress in the development of CABA-201, with multiple diseases fully enrolled in the RESET clinical development program, indicating a strong pipeline and potential for future revenue growth [6][11][70] - The safety profile of CABA-201 is notably better than traditional CAR-T therapies, with approximately one-third of patients experiencing CRS, mostly grade 1, which is significantly lower than oncology counterparts [14][29] Business Line Data and Key Metrics Changes - The myositis pivotal trial is set to initiate enrollment imminently, with the company expecting to generate data in 2026, which could lead to a strong market position in this therapeutic area [11][12] - The lupus program is also progressing, with early data showing promising results, indicating a robust pipeline across multiple autoimmune diseases [8][9] Market Data and Key Metrics Changes - The company is preparing to launch CABA-201 in a market that is increasingly recognizing the value of outpatient CAR-T therapies, which could lead to a more sustainable financial model compared to traditional inpatient therapies [12][38] - The competitive landscape includes other CAR-T therapies, but the company believes its safety profile and outpatient potential will differentiate it from competitors [10][50] Company Strategy and Development Direction - The company aims to leverage its outpatient therapy model to create a financially sustainable CAR-T infusion center, contrasting with the traditional inpatient model that has been financially burdensome [37][62] - The partnership with Cellares for fully automated manufacturing is expected to enhance scalability and cost-effectiveness, positioning the company favorably in the market [63][64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for CABA-201 to transform treatment for autoimmune diseases and the company's readiness to file for BLA in 2027 [70] - The management emphasized the importance of educating both patients and physicians about the benefits of CABA-201, particularly regarding the safety and efficacy compared to traditional therapies [42][49] Other Important Information - The company has established a large clinical footprint with 77 sites across the U.S., which is expected to facilitate a successful launch and broad patient access [35][61] - The company is focused on ensuring that the product is available at all sites, aiming to avoid supply constraints that have plagued other CAR-T therapies [34][39] Q&A Session Summary Question: How does the safety profile of CABA-201 compare to other CAR-T therapies? - The safety profile of CABA-201 shows a lower incidence of CRS, with most cases being grade 1, which is a significant differentiator from other autologous CAR-T therapies [14][29] Question: What are the company's plans for outpatient therapy? - The company intends to implement outpatient therapy for the myositis pivotal study, which has been reviewed and aligned with the FDA [28][30] Question: How does the company plan to address potential manufacturing bottlenecks? - The company is working with CDMOs to ensure sufficient supply at launch and is focused on avoiding the common manufacturing issues seen in other CAR-T therapies [33][34] Question: What is the company's strategy regarding pricing and reimbursement? - The company believes it can price CABA-201 competitively based on the value it delivers, especially when compared to annual therapies that cost between $250,000 and $500,000 [58][59] Question: How does the company view competition from other modalities like bispecifics? - The company remains confident in the efficacy of CAR-T therapies and believes it can outperform bispecifics in terms of patient outcomes [50][51]