Cabaletta Bio, Inc. (NASDAQ: CABA ) is a company I've found some significant upside potential for, as the market maintained little to no enthusiasm , which I attributed primarily to sector headwinds related to a general pessimismI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by ...

Core Insights - Cabaletta Bio (NASDAQ: CABA) presents significant upside potential despite the market's lack of enthusiasm, primarily due to sector headwinds and general pessimism in the biotech industry [1] Company Analysis - The company operates in a challenging environment characterized by negative sentiment towards the biotech sector, which may impact investor confidence and stock performance [1] Industry Context - The current market conditions reflect a broader trend of pessimism within the biotech sector, which could affect the valuation and investment opportunities in companies like Cabaletta Bio [1]

Summary of Cabaletta Bio FY Conference Call - September 10, 2025 Company Overview - **Company**: Cabaletta Bio (NasdaqGS:CABA) - **Focus**: Development of autologous CAR T therapies for autoimmune diseases, particularly myositis Key Industry Insights - **Competitive Landscape**: The CAR T therapy space for autoimmune diseases is highly competitive, with many companies targeting similar indications, particularly lupus, which has 35 competitors [4][19] - **Market Opportunity**: Myositis is identified as a less crowded market with fewer competitors, providing a strategic advantage for Cabaletta Bio [4][5] Core Product and Data Presentation - **Lead Product**: ResiCel (CABA-201), an autologous CD19 CAR T product for autoimmune patients, with a focus on myositis as the lead indication [3][4] - **Upcoming Data**: Data from phase one and two trials will be presented at multiple medical meetings in October, including ACR and AANEM [8][9] - **Regulatory Agreement**: Cabaletta has an agreement with the FDA to run a trial with 14 patients to access a market of approximately 70,000 myositis patients, with 16,000 to 20,000 likely eligible at launch [6][7] Clinical Development Strategy - **Trial Design**: The trial will include a primary endpoint based on the TIS score, similar to the approval process for IVIG in myositis [5][7] - **Focus on Myasthenia Gravis**: Initial clinical data for myasthenia gravis will also be presented, highlighting an unmet need in this area [8][9] - **No Preconditioning Approach**: A trial will assess the efficacy of ResiCel without preconditioning, which could simplify the treatment process and expand market access [10][11][20] Market Dynamics and Pricing Strategy - **Pricing Considerations**: The company is evaluating how to price ResiCel in relation to existing therapies like IVIG and Vivgart, which are expensive and not curative [30][31] - **Value Proposition**: The potential for ResiCel to provide significant patient benefits (85% off all medications) positions it favorably against existing therapies [15][31] Enrollment and Patient Demand - **Enrollment Progress**: The company is on track to meet its enrollment milestones, with a focus on ensuring the right patients are included in trials [38][44] - **Patient Interest**: There is strong demand from both patients and physicians for the treatment, with many wanting to enroll additional patients after seeing positive outcomes [44][46] Competitive Threats and Differentiation - **Manufacturing Speed**: Competitors are exploring faster manufacturing processes, but efficacy and safety remain the top priorities for physicians [49][55] - **Focus on Efficacy and Safety**: Cabaletta emphasizes that the most critical factors for physicians are the depth and durability of response, rather than turnaround time [55][57] Conclusion - **Strategic Positioning**: Cabaletta Bio is well-positioned in the CAR T therapy market for autoimmune diseases, particularly with its focus on myositis and the upcoming data presentations that could validate its approach and product efficacy [34][35]

Core Viewpoint - Cabaletta Bio, Inc. (CABA) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, thus affecting stock prices [4]. Company Performance and Outlook - The upgrade for Cabaletta Bio signifies an improvement in its underlying business, which is expected to drive the stock price higher as investors respond positively to this trend [5][10]. - For the fiscal year ending December 2025, Cabaletta Bio is projected to earn -$2.34 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 1.8% over the past three months, indicating a positive revision trend [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with a proven track record of generating significant returns, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - The upgrade of Cabaletta Bio to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Financial Performance - Net loss for the six months ended June 30, 2025, was $81,071,000, compared to a net loss of $52,649,000 for the same period in 2024, reflecting a 54% increase in losses[17] - The net loss for the three months ended June 30, 2025, was $45.1 million, compared to a net loss of $27.6 million for the same period in 2024, indicating an increase in loss of $17.5 million[162] - Net cash used in operating activities for the six months ended June 30, 2025, was $61,228,000, compared to $44,777,000 for the same period in 2024, reflecting a 37% increase in cash outflow[25] - Cash used in operating activities was $61.2 million for the six months ended June 30, 2025, compared to $44.8 million in 2024, indicating a 36.6% increase[183] - Interest income decreased by $2.8 million for the six months ended June 30, 2025, primarily due to lower cash and investment balances[170] - The company reported interest income of $1,410,000 for the three months ended June 30, 2025, down from $2,677,000 in the same period of 2024, a decrease of 47%[17] Assets and Liabilities - Total current assets increased to $198,407,000 as of June 30, 2025, compared to $166,675,000 as of December 31, 2024, representing a 19% increase[15] - Total liabilities increased to $46,019,000 as of June 30, 2025, from $32,711,000 as of December 31, 2024, marking a 41% increase[15] - Cash and cash equivalents decreased to $145,612,000 at the end of June 2025 from $163,962,000 at the beginning of the period, a decline of 11%[25] - As of June 30, 2025, the company has incurred an accumulated deficit of $430,172, with cash, cash equivalents, and investments totaling $194,682[32] - As of June 30, 2025, the company had $194.7 million in cash, cash equivalents, and investments, sufficient to fund operations into the second half of 2026[172] Research and Development - Research and development expenses for the three months ended June 30, 2025, were $37,638,000, up 60% from $23,427,000 in the same period of 2024[17] - Total operating expenses for the six months ended June 30, 2025, were $83,042,000, up 42% from $58,310,000 in the same period of 2024[17] - Research and development expenses increased to $37.6 million for the three months ended June 30, 2025, compared to $23.4 million for the same period in 2024, reflecting a change of $14.2 million[162] - Research and development expenses were $66.7 million for the six months ended June 30, 2025, up from $45.4 million in the same period of 2024, representing a 46.9% increase[167] - Manufacturing of preclinical and clinical supplies accounted for $11.6 million in research and development expenses for the three months ended June 30, 2025, compared to $3.8 million in 2024, a change of $7.8 million[162] Stock and Equity - Stockholders' equity rose to $178,481,000 as of June 30, 2025, compared to $152,335,000 as of December 31, 2024, indicating a 17% increase[15] - The company issued 39,200,000 shares of common stock, raising $93,558,000 net of issuance costs during the first half of 2025[25] - The company granted 3,093,050 stock options during the six months ended June 30, 2025, with a weighted average exercise price of $1.71[92] - The aggregate intrinsic value of options outstanding as of June 30, 2025, was $408,000, with 7,092,424 options exercisable at an average exercise price of $9.30[92] - Stock-based compensation for the three months ended June 30, 2025, totaled $5.705 million, an increase of 13.8% from $5.013 million in the same period of 2024[98] Clinical Trials and Regulatory Approvals - The FDA granted clearance for the company's rese-cel IND application for multiple autoimmune diseases, including systemic lupus erythematosus and idiopathic inflammatory myopathies, between March 2023 and January 2025[110] - The RESET-MyositisTM Phase 1/2 clinical trial is actively enrolling patients, targeting approximately 80,000 patients in the U.S. and 85,000 in Europe[111] - The company plans to implement two registrational cohorts in the ongoing RESET-MyositisTM trial, each evaluating approximately 15 patients, to support a future Biologics License Application[113] - The registrational cohorts for myositis will evaluate a single, weight-based infusion of rese-cel at 1 x 10^6 cells/kg, with a primary endpoint based on the total improvement score (TIS) within 26 weeks[114] - The company anticipates aligning with the FDA on the registrational cohort design for studies in SLE/LN in Q3 2025[116] Future Outlook and Challenges - The company expects to continue generating operating losses for the foreseeable future and will need to raise additional capital to fund its operations[32] - The company's cash forecast indicates that current cash, cash equivalents, and investments may not be sufficient to fund operations for at least the next twelve months[32] - The company may face significant delays in clinical development and commercialization of its product candidates if it does not achieve timely regulatory approvals[207] - The company has not generated revenue from engineered T cell therapies and does not expect to do so until regulatory approval is obtained[30] - The company has not generated any revenue from product sales to date and does not expect to do so for several years[147]

[Executive Summary](index=1&type=section&id=Executive%20Summary) Cabaletta Bio reported Q2 2025 financial results and provided a business update, highlighting significant progress in advancing rese-cel, including FDA alignment for a registrational pathway in myositis, compelling clinical data, and a successful $100 million public offering extending cash runway [Q2 2025 Business and Financial Highlights](index=1&type=section&id=Q2%202025%20Business%20and%20Financial%20Highlights) Cabaletta Bio reported Q2 2025 financial results and provided a business update, highlighting significant progress in advancing rese-cel, including FDA alignment for a registrational pathway in myositis, compelling clinical data, and a successful $100 million public offering extending cash runway - Registrational cohort enrollment in RESET-Myositis™ trial on track to start in 2H25 with anticipated 2027 BLA submission for rese-cel in myositis[1](index=1&type=chunk) - Five disease-specific cohorts fully enrolled in the RESET™ clinical development program from over 70 clinical sites as of July 31, 2025, with expansion phase enrollment continuing[1](index=1&type=chunk) - FDA meetings to align on the next wave of registrational cohorts for rese-cel anticipated in 3Q25 for lupus, 4Q25 for systemic sclerosis and 1H26 for myasthenia gravis[1](index=1&type=chunk) - Rese-cel clinical data presented at the EULAR 2025 Congress reinforce compelling clinical responses with nearly all patients off immunomodulatory medications and steroids; favorable risk-benefit profile observed across myositis, lupus and systemic sclerosis patients[1](index=1&type=chunk) - Closed **$100 million** public offering to support late clinical-stage development and commercial readiness activities for rese-cel; cash runway extended into 2H26[1](index=1&type=chunk) [Recent Operational Highlights and Upcoming Anticipated Milestones](index=1&type=section&id=Recent%20Operational%20Highlights%20and%20Upcoming%20Anticipated%20Milestones) This section details rese-cel's mechanism, clinical progress, regulatory milestones including FDA alignment for myositis, manufacturing advancements, and a recent $100 million public offering [Rese-cel Program Overview](index=1&type=section&id=Rese-cel%20Program%20Overview) Rese-cel (resecabtagene autoleucel) is an investigational, autologous CAR-T cell therapy designed to treat autoimmune diseases by transiently and deeply depleting CD19-positive cells, aiming to reset the immune system for durable responses without chronic therapy. It is being evaluated in the RESET clinical development program across rheumatology, neurology, and dermatology - Rese-cel is an investigational, autologous CAR-T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain[3](index=3&type=chunk) - It is designed to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy[3](index=3&type=chunk) - Rese-cel is being evaluated in the RESET clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology and dermatology[3](index=3&type=chunk)[4](index=4&type=chunk) [Clinical Development](index=2&type=section&id=Clinical%20Development) Cabaletta presented new clinical and translational data at EULAR 2025, reinforcing rese-cel's ability to achieve deep B cell depletion and compelling clinical responses. The company is on track to initiate myositis registrational cohorts in 2H25 and plans several upcoming data presentations in 2025 and 2026 for various RESET trials [EULAR 2025 Congress Data](index=2&type=section&id=EULAR%202025%20Congress%20Data) New clinical and translational data from RESET trials presented at EULAR 2025 demonstrated deep B cell depletion and compelling clinical responses - New clinical and translational data from 18 evaluable patients in RESET-Myositis, RESET-SLE™, and RESET-SSc™ trials were presented at the EULAR 2025 Congress in June 2025[8](index=8&type=chunk) - The data supported rese-cel's ability to generate deep B cell depletion and compelling clinical responses, with nearly all patients off immunomodulators and steroids through the follow-up period[8](index=8&type=chunk) [Myositis Registrational Cohorts](index=2&type=section&id=Myositis%20Registrational%20Cohorts) Cabaletta plans to initiate enrollment in two open-label, single-arm registrational myositis cohorts in the second half of 2025 - Cabaletta plans to initiate enrollment in two open-label, single-arm, registrational myositis cohorts, each consisting of approximately 15 patients, in the second half of 2025[8](index=8&type=chunk) [Upcoming Clinical Data Presentations](index=2&type=section&id=Upcoming%20Clinical%20Data%20Presentations) Cabaletta plans several upcoming clinical data presentations for RESET-Myositis, RESET-PV, RESET-MG, RESET-SLE, and RESET-SSc trials in 2025 and 2026 - In the second half of 2025, Cabaletta plans to present complete Phase 1/2 clinical data from the RESET-Myositis trial, initial dose data from the RESET-PV trial (evaluating rese-cel without preconditioning), and initial clinical data from the RESET-MG™ trial[8](index=8&type=chunk) - Additionally, complete Phase 1/2 clinical data from the RESET-SLE and RESET-SSc trials are expected to be presented in the first half of 2026[8](index=8&type=chunk) [Regulatory Updates](index=2&type=section&id=Regulatory) Cabaletta achieved FDA alignment on key design elements for two registrational myositis cohorts, planning a first BLA submission for rese-cel in myositis in 2027. Further FDA meetings are scheduled in 3Q25, 4Q25, and 1H26 to align on registrational designs for lupus, systemic sclerosis, and myasthenia gravis, respectively [Myositis BLA Submission Plan](index=2&type=section&id=Myositis%20BLA%20Submission%20Plan) Cabaletta achieved FDA alignment for myositis registrational cohorts and plans its first BLA submission for rese-cel in myositis in 2027 - In May 2025, Cabaletta announced alignment with the U.S. Food and Drug Administration (FDA) on key design elements for two registrational cohorts in the RESET-Myositis trial[8](index=8&type=chunk) - The Company plans to submit its first BLA for rese-cel in myositis in 2027 based on either cohort, if successful[8](index=8&type=chunk) [Additional Registrational Pathway Discussions](index=2&type=section&id=Additional%20Regulatory%20Discussions%20Planned) Cabaletta plans future FDA meetings to align on registrational designs for lupus, systemic sclerosis, and myasthenia gravis - Cabaletta plans to meet with the FDA to align on key registrational design elements for the RESET-SLE trial in 3Q25, the RESET-SSc trial in 4Q25, and the RESET-MG trial in 1H26[8](index=8&type=chunk) [Manufacturing Updates](index=2&type=section&id=Manufacturing) Cabaletta is advancing CMC commercial supply readiness and innovation activities, including BLA-enabling activities for lentiviral vector and cellular drug product processes, with the latter transferred to Lonza for registrational enrollment - Advancing CMC commercial supply readiness and innovation activities to support commercial supply, including BLA-enabling activities for both lentiviral vector process and cellular drug product process[7](index=7&type=chunk) - The Oxford Biomedica lentiviral process and the commercial drug product process, transferred to Lonza, will be used for initiating registrational enrollment[7](index=7&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) In June 2025, Cabaletta completed a public offering, generating approximately $94 million in net proceeds to support its operations - In June 2025, Cabaletta closed an underwritten public offering consisting of shares of its common stock, pre-funded warrants and accompanying common stock warrants[9](index=9&type=chunk) - The net proceeds from the offering were approximately **$94 million**, after deducting underwriting discounts, commissions and offering expenses[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Cabaletta Bio reported increased operating expenses and net loss for Q2 2025, while a public offering significantly boosted its cash position and extended its runway [Financial Summary](index=3&type=section&id=Financial%20Summary) Cabaletta Bio reported increased R&D and G&A expenses for Q2 2025 compared to Q2 2024, reflecting advanced clinical development. The company's cash position significantly improved to $194.7 million as of June 30, 2025, extending its cash runway into the second half of 2026 Key Financial Metrics (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :-------------------------- | :---------- | :---------- | :------- | | Research and development expenses | $37.6 million | $23.4 million | +60.7% | | General and administrative expenses | $8.3 million | $6.9 million | +20.3% | | Cash, cash equivalents and short-term investments (as of period end) | $194.7 million (Jun 30, 2025) | $164.0 million (Dec 31, 2024) | +18.7% | - The Company expects that its cash position as of June 30, 2025, will enable it to fund its operating plan into the second half of 2026[13](index=13&type=chunk) [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) For the three months ended June 30, 2025, Cabaletta Bio reported a net loss of $45.1 million, an increase from $27.6 million in the same period of 2024, primarily driven by higher operating expenses, particularly in research and development. The net loss for the six months ended June 30, 2025, was $81.1 million, compared to $52.6 million for the prior year period Statements of Operations (Three and Six Months Ended June 30, in thousands) | Metric | Three Months Ended June 30, 2025 (unaudited) | Three Months Ended June 30, 2024 (unaudited) | Six Months Ended June 30, 2025 (unaudited) | Six Months Ended June 30, 2024 (unaudited) | | :------------------------------------ | :------------------------------------------- | :------------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Research and development | $37,638 | $23,427 | $66,656 | $45,381 | | General and administrative | $8,268 | $6,852 | $16,386 | $12,929 | | Total operating expenses | $45,906 | $30,279 | $83,042 | $58,310 | | Loss from operations | $(45,906) | $(30,279) | $(83,042) | $(58,310) | | Interest income | $1,410 | $2,677 | $2,897 | $5,661 | | Interest expense | $(571) | — | $(865) | — | | Other expense | $(61) | — | $(61) | — | | Net loss | $(45,128) | $(27,602) | $(81,071) | $(52,649) | | Net loss per share (basic and diluted) | $(0.73) | $(0.56) | $(1.44) | $(1.07) | [Selected Balance Sheet Data](index=5&type=section&id=Selected%20Balance%20Sheet%20Data) As of June 30, 2025, Cabaletta Bio reported a significant increase in cash, cash equivalents, and investments to $194.7 million, up from $164.0 million at December 31, 2024. Total assets and stockholders' equity also increased, while total liabilities saw a moderate rise Selected Balance Sheet Data (as of period end, in thousands) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :---------------- | | Cash, cash equivalents and investments | $194,682 | $163,962 | | Total assets | $224,500 | $185,046 | | Total liabilities | $46,019 | $32,711 | | Total stockholders' equity | $178,481 | $152,335 | [About Cabaletta Bio](index=3&type=section&id=About%20Cabaletta%20Bio) Cabaletta Bio is a clinical-stage biotechnology company developing targeted cell therapies for autoimmune diseases, with rese-cel as its lead CARTA strategy [Company Overview](index=3&type=section&id=Company%20Overview) Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. Its CABA™ platform includes the lead CARTA strategy, prioritizing rese-cel, a CD19-CAR T cell investigational therapy, currently in the RESET™ clinical development program across multiple therapeutic areas - Cabaletta Bio is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases[11](index=11&type=chunk) - The CABA™ platform encompasses two complementary strategies, with the lead CARTA strategy prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy[11](index=11&type=chunk) - Rese-cel is currently being evaluated in the RESET™ clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology[11](index=11&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements regarding Cabaletta Bio's future plans and potential risks that could impact actual results [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains forward-looking statements regarding Cabaletta Bio's future plans, objectives, clinical trial outcomes, regulatory interactions, financial performance, and ability to fund operations. It also outlines various risks and uncertainties that could cause actual results to differ materially from these statements, including regulatory risks, clinical trial risks, market conditions, and intellectual property risks - Forward-looking statements include express or implied statements regarding Cabaletta's business plans, ability to launch curative cell therapies, successful development and commercialization of drug candidates, timing and results of clinical trials, regulatory interactions, and financial outlook[12](index=12&type=chunk)[14](index=14&type=chunk) - These statements are subject to risks and uncertainties such as regulatory filings, the risk that biologic activity may not inform long-term results, ability to demonstrate safety/efficacy, clinical trial delays, unexpected safety/efficacy data, volatile market conditions, and intellectual property risks[15](index=15&type=chunk) - All information is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law[15](index=15&type=chunk) [Contacts](index=5&type=section&id=Contacts) This section provides contact information for investor relations inquiries [Investor Relations Contact](index=5&type=section&id=Investor%20Relations%20Contact) This section provides the contact information for investor relations, specifically Anup Marda, Chief Financial Officer - Contact for investors: Anup Marda, Chief Financial Officer[20](index=20&type=chunk) - Email: investors@cabalettabio.com[20](index=20&type=chunk)

Core Insights - Cabaletta Bio is advancing its investigational CAR-T cell therapy, rese-cel, with plans for a Biologics License Application (BLA) submission for myositis anticipated in 2027 following FDA alignment on registrational pathways [1][11] - The company has successfully enrolled five disease-specific cohorts in the RESET™ clinical development program, with ongoing expansion phase enrollment [1][4] - Recent clinical data presented at the EULAR 2025 Congress indicate strong therapeutic potential for rese-cel, with nearly all patients off immunomodulatory medications and steroids [1][4] Clinical Development - Rese-cel is designed to treat autoimmune diseases by transiently depleting CD19-positive cells, aiming for durable clinical responses without chronic therapy [3] - Enrollment in two open-label, single-arm registrational myositis cohorts is set to begin in the second half of 2025, each consisting of approximately 15 patients [4][11] - Upcoming presentations will include complete Phase 1/2 data from the RESET-Myositis trial and initial data from RESET-PV and RESET-MG trials [4] Regulatory - The FDA has aligned with Cabaletta on key design elements for registrational cohorts in the RESET-Myositis trial, which includes patients with dermatomyositis and antisynthetase syndrome [11] - Additional regulatory discussions are planned for the RESET-SLE and RESET-SSc trials in late 2025 and early 2026 [11] Financial Overview - Cabaletta closed a $100 million public offering to support late clinical-stage development and extended its cash runway into the second half of 2026 [1][7] - For Q2 2025, research and development expenses were $37.6 million, up from $23.4 million in Q2 2024, while general and administrative expenses rose to $8.3 million from $6.9 million [12][17] - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments of $194.7 million, an increase from $164.0 million at the end of 2024 [12][19]

Rese-cel Development and Regulatory Strategy - Cabaletta Bio plans to submit a Biologics License Application (BLA) for Rese-cel in 2027 following recent alignment with the FDA [7] - The company is rapidly accelerating enrollment across a broad portfolio of indications at 67 active clinical sites [7, 14] - The initial BLA submission is planned in myositis, which affects approximately 80,000 US patients, followed by rapid expansion to SLE/LN and SSc [7] - The FDA has aligned with Cabaletta Bio on an open-label, single-arm evaluation of two registrational cohorts in the RESET-Myositis trial, with approximately 15 patients in each subtype-specific cohort [8] - Over 40% of the safety database is already enrolled across the RESET clinical development program [18] Clinical Data and Efficacy - Clinically meaningful responses have been observed with most patients off all immunomodulatory medications and steroids [8] - Deep transient systemic B cell depletion in blood and tissues has been confirmed by lymph node biopsy in an SSc patient [8] - In non-renal SLE, 3 out of 4 patients achieved DORIS (Definition of Remission in SLE) at the latest follow-up [84] - In the LN cohort, the first patient achieved CRR (Complete Renal Response) at week 44 [89] Manufacturing and Innovation - Cabaletta Bio is evaluating a whole blood process to eliminate apheresis [112] - The company has an expanded partnership for automated manufacturing with Cellares and completed the Technology Adoption Program [110]

Core Viewpoint - Cabaletta Bio, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $100 million to support its development of targeted cell therapies for autoimmune diseases [2][3]. Group 1: Offering Details - The offering consists of 39,200,000 shares of common stock and accompanying warrants, with an additional option for underwriters to purchase up to 15,000,000 more shares [1][2]. - The combined offering price for each share of common stock and accompanying warrant is set at $2.00, while the pre-funded warrants are priced at $1.99999 [1]. - The exercise price for the accompanying warrants is $2.50 per share, and they are immediately exercisable for fifteen months from the date of issuance [1]. Group 2: Company Overview - Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases [6]. - The company’s CABA™ platform includes strategies for engineered T cell therapies, with a lead investigational therapy called rese-cel currently in clinical trials [6]. - The RESET™ clinical development program for rese-cel spans multiple therapeutic areas, including rheumatology, neurology, and dermatology [6].

Core Insights - Cabaletta Bio (NASDAQ: CABA) shows promising efficacy signals in its approach, which is gaining traction in the medical community [1] Company Analysis - The company is being analyzed with cautious optimism due to its potential in the biotech sector [1] - The focus is on educating investors about the scientific basis of the company's business model [1] Industry Context - The medical community is increasingly gaining experience with the methodologies employed by Cabaletta Bio, indicating a positive trend in the industry [1]