Industry Overview - The year 2024 marked significant advancements in cell therapies, including new engineered T cell treatments and the introduction of the first tumor-infiltrating lymphocyte product [1] - There is growing recognition of the potential of CD19-directed CAR T-cell therapies in the field [1] Analyst Background - The analyst holds a PhD in biochemistry and has extensive experience in analyzing clinical trials and biotech companies [1] - The analyst is passionate about educating investors on the science behind biotech investments and aims to help them conduct thorough due diligence [1]

Product Development and Clinical Trials - CABA-201, the lead product candidate, is designed to treat a broad range of autoimmune diseases, with clinical responses in systemic lupus erythematosus maintained off immunosuppressive therapies for up to 2.5 years[99]. - The FDA granted Fast Track Designation for CABA-201 for systemic lupus erythematosus and lupus nephritis, with an estimated 160,000-320,000 patients affected in the U.S.[101]. - The RESET-SLE Phase 1/2 clinical trial is designed to treat six patients with active lupus nephritis and six patients with active systemic lupus erythematosus without renal involvement[103]. - As of November 12, 2024, 16 patients have been enrolled with 10 patients dosed across lupus, myositis, and systemic sclerosis clinical trials, with 40 U.S. clinical sites actively recruiting patients[112]. - The FDA granted clearance for CABA-201 IND applications for treatment of idiopathic inflammatory myopathy and systemic sclerosis, affecting approximately 66,000 and 88,000 patients in the U.S., respectively[104][105]. - Initial clinical data from the RESET-SLE and RESET-Myositis trials showed complete B cell depletion by day 15 post-infusion, with no serious adverse events observed[108]. - The RESET-MG Phase 1/2 clinical trial is designed to treat patients with generalized myasthenia gravis, with an estimated 50,000 to 80,000 patients affected in the U.S.[106]. - The company is working to activate clinical trial sites for the RESET-SLE trial in Canada and Europe, following regulatory approvals[103][104]. Financial Performance and Expenses - The company has not generated any revenue from product sales and does not expect to for several years[131]. - Research and development expenses are expected to increase substantially as the company continues to invest in product candidates and clinical trials[137]. - Research and development expenses increased to $26.3 million for Q3 2024, up from $13.8 million in Q3 2023, representing a 91% increase[145]. - General and administrative expenses rose to $6.8 million in Q3 2024, compared to $4.9 million in Q3 2023, marking a 39% increase[146]. - Total operating expenses for Q3 2024 were $33.0 million, up from $18.7 million in Q3 2023, reflecting a 77% increase[143]. - Net loss for Q3 2024 was $30.6 million, compared to a net loss of $16.4 million in Q3 2023, indicating an 86% increase in losses[143]. - Research and development expenses for the nine months ended September 30, 2024, totaled $71.7 million, up from $38.0 million in the same period of 2023, a 88% increase[150]. - General and administrative expenses for the nine months ended September 30, 2024, were $19.7 million, compared to $13.5 million in the same period of 2023, a 46% increase[152]. - The company experienced a net loss of $83.3 million for the nine months ended September 30, 2024, compared to a net loss of $46.8 million for the same period in 2023[167][168]. Cash and Financing Activities - As of September 30, 2024, the company had $183.0 million in cash, cash equivalents, and investments[154]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $65.1 million, compared to $37.1 million for the same period in 2023[166][168]. - Cash provided by investing activities for the nine months ended September 30, 2024, was $35.2 million, primarily from the maturity of short-term investments[169]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $7.3 million, significantly lower than $94.6 million for the same period in 2023[171][173]. - The company has no credit facility or committed sources of capital, indicating potential future funding challenges[165]. Manufacturing and Partnerships - The manufacturing strategy includes leveraging academic partners for early development and partnering with CDMOs for late-stage clinical studies and commercial production[115]. - The company entered into a new technology transfer agreement with Lonza in July 2024 to improve the commercial manufacturing process for CABA-201, making it nearly fully closed and semi-automated[116]. - The company has established multiple partnerships, including with Oxford Biomedica and WuXi, to enhance manufacturing capabilities for CABA-201[123][124]. - The company plans to secure scalable manufacturing capabilities through various strategies, including establishing new CDMO relationships and building its own facility[118]. - The company has entered into a partnership with Cellares Corp. to evaluate their automated manufacturing platform for CABA-201[117]. Future Outlook and Market Risks - The company anticipates continued increases in research and development and general administrative expenses in the foreseeable future[156]. - The company may generate future revenue from potential license or collaboration agreements for its product candidates[132]. - The company is exposed to market risks, primarily interest rate sensitivity, with an immediate 100 basis point change in interest rates not expected to materially affect cash equivalents[183][184]. - The company is an emerging growth company and plans to adopt new accounting standards as they become effective[177][181].

Exhibit 99.1 Cabaletta Bio Reports Third Quarter 2024 Financial Results and Provides Business Update – Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR Convergence 2024 – – 16 patients enrolled with 10 patients dosed as of November 12 across the RESET™ clinical development program; 40 U.S. clinical sites actively recruiting patients – – Data permitting, anticipate mee ...

Core Insights - The article highlights the investment strategies of Paul Franke, a seasoned investor with 38 years of trading experience, emphasizing his contrarian stock selection style and the development of a system called "Victory Formation" for identifying stocks based on supply/demand imbalances [1]. Group 1: Investment Strategies - Paul Franke's "Victory Formation" system utilizes algorithm analysis of fundamental and technical data to identify stocks, focusing on supply/demand imbalances indicated by specific price and volume movements [1]. - The "Bottom Fishing Club" articles target deep-value stocks or those showing significant positive technical momentum reversals [1]. - The "Volume Breakout Report" articles discuss stocks that exhibit positive trend changes supported by strong price and volume trading actions [1]. Group 2: Risk Management - Franke advises investors to implement stop-loss levels of 10% or 20% on individual stock choices and to maintain a diversified portfolio of at least 50 well-positioned stocks to enhance regular stock market outperformance [1].

PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinicalstage 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 featur ...

PHILADELPHIA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinicalstage 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 the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on Wednesday, September 4, 2024 at 4:50 p.m. ET in New York, NY. 2024 Wells F ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______________ to _______________ | --- | --- | --- | |------------------------------------------------------------------------------|--------------------------- ...

Financial Performance - As of June 30, 2024, Cabaletta Bio reported cash, cash equivalents, and short-term investments totaling $203.2 million, down from $241.2 million as of December 31, 2023, expected to fund operations into the first half of 2026[11] - Research and development expenses for Q2 2024 were $23.4 million, compared to $11.8 million for the same period in 2023, indicating a significant increase in investment in R&D[11] - General and administrative expenses for Q2 2024 were $6.9 million, up from $4.1 million in Q2 2023, reflecting increased operational costs[11] - Total operating expenses for the first half of 2024 reached $58,310,000, compared to $32,846,000 for the same period in 2023, reflecting a 77% increase[16] - The net loss for Q2 2024 was $27,602,000, compared to a net loss of $14,487,000 in Q2 2023, representing an increase of 91%[16] - The net loss per share for Q2 2024 was $0.56, compared to $0.37 in Q2 2023, indicating a 51% increase in loss per share[16] - Interest income for Q2 2024 was $2,677,000, an increase from $1,403,000 in Q2 2023, marking a 91% rise[16] - Total liabilities as of June 30, 2024, were $17,899,000, slightly up from $17,452,000 at the end of 2023[17] - Total assets decreased to $217,418,000 as of June 30, 2024, from $253,650,000 at the end of 2023[17] - Total stockholders' equity fell to $199,519,000 as of June 30, 2024, down from $236,198,000 at the end of 2023[17] Clinical Development - Nine patients have been enrolled in the RESET™ clinical development program as of August 5, 2024, with 22 U.S. clinical sites now actively enrolling[1] - Initial clinical data from the RESET-Myositis™ and RESET-SLE™ trials were presented at EULAR 2024, showing CABA-201 was well-tolerated with no serious adverse events reported[8] - The independent data monitoring committee recommended the continuation of the RESET-SLE trial at the current dose after a patient experienced a Grade 4 ICANS, which resolved rapidly[5] - Additional clinical data from the RESET-Myositis and RESET-SLE trials are anticipated in the second half of 2024, with ongoing patient enrollment in both trials[4][5] - Cabaletta is evaluating CABA-201 for multiple autoimmune conditions, including myositis, systemic lupus erythematosus, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris[12] Strategic Partnerships and Appointments - Cabaletta has signed agreements with Lonza and Cellares to enhance its manufacturing strategy for CABA-201, supporting clinical supply expansion and commercial readiness[1][10] - The company has appointed Sarah Yuan, Ph.D., as Chief Technology Officer, bringing extensive experience in cell therapy development and manufacturing[10]

Company Overview - Cabaletta Bio is a clinical-stage biotechnology company focused on engineered T cell therapies aimed at treating autoimmune diseases [1] - The company is headquartered in Philadelphia, PA [1] Product Development - The CABA™ platform includes two main strategies: CARTA (chimeric antigen receptor T cells for autoimmunity) and CAART (chimeric autoantibody receptor T cells) [1] - The lead product candidate, CABA-201, is a fully human CD19-CAR T cell being evaluated in clinical trials for systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis [1] - The RESET™ clinical trials and the RESET-PV™ sub-study within the DesCAARTes™ clinical trial are key components of the product evaluation [1] - Multiple clinical-stage candidates are being developed under the CAART strategy, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis [1] Upcoming Events - Steven Nichtberger, M.D., CEO of Cabaletta Bio, will participate in a fireside chat at the Stifel 2024 Virtual Cell Therapy Forum on July 9, 2024 [2]

A live webcast of the presentation will be available on the News and Events section of the Company's website at www.cabalettabio.com. Replays will be available on the website for 30 days. Contacts: PHILADELPHIA, July 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinicalstage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief ...