Summary of Climb Bio Conference Call Company Overview - Climb Bio is a relatively new biotech company, established in 2024, originally built within Eliem Therapeutics [2] - The company focuses on monoclonal antibodies targeting B-cell mediated diseases, particularly CD19 [2][3] Key Points and Arguments 2025 Execution and 2026 Data Expectations - 2025 was a year of execution for Climb Bio, laying the foundation for its programs, including data collection and manufacturing setups [4] - 2026 is anticipated to be a significant year with multiple data readouts from ongoing studies [4] Targeting CD19 - Climb Bio's primary asset, budo, is a CD19 monoclonal antibody, which is believed to have advantages over CD20 and BCMA targets due to its broader expression in B cells [6][7] - The company aims to address diseases where CD20 has failed, supported by clinical data demonstrating efficacy in conditions like myasthenia gravis [8] Comparison with Amgen's UPLIZNA - Climb Bio acknowledges the success of Amgen's UPLIZNA and aims to differentiate its product through a subcutaneous formulation and targeting diseases not yet evaluated with UPLIZNA [9][10] Subcutaneous Formulation Development - Climb Bio is generating data on a subcutaneous formulation of budo, with expectations of achieving measurable B-cell depletion similar to intravenous administration [11][12] Primary Membranous Nephropathy (PMN) - PMN is a significant focus, with an estimated 70,000 patients in the U.S. and no currently approved therapies [19] - Climb Bio targets moderate to severe PMN patients, with early data showing a 60% complete renal response in treated patients [20] Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) - The ITP study will focus on treatment-experienced patients who have failed prior therapies, with platelet response as a key endpoint [28][30] - The SLE study aims to explore the potential for achieving immune reset and durable remission, although it is not powered for clinical endpoints [32][34] CLYM116 Development - CLYM116 is an anti-APRIL antibody with a unique mechanism of action, expected to have a longer half-life and lower immunogenicity compared to competitors [46][51] - The company is optimistic about the potential of CLYM116 in treating IgA nephropathy (IgAN) and is exploring other indications like Sjögren's syndrome [58] Financial and Strategic Considerations - Climb Bio ended Q4 with $161 million, providing a runway into 2028, allowing for funding of ongoing programs [60] - The company plans to allocate more resources to budoprutug initially, but spending will depend on data outcomes throughout the year [60][62] Future Business Development - Climb Bio is open to in-licensing additional early-stage assets, focusing on areas where it can leverage its expertise, particularly in the renal space [65][66] Conclusion - Climb Bio is positioned for a pivotal year in 2026 with multiple data readouts expected, focusing on innovative therapies for B-cell mediated diseases and exploring strategic growth opportunities through new asset acquisitions [66][70]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40708 CLIMB BIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-2273741 (State or other jurisdiction of inco ...

Climb Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Dosing completed in Phase 1 study of budoprutug subcutaneous formulation, with data expected in H1 2026 Exhibit 99.1 Budoprutug clinical trials ongoing in pMN, ITP, and SLE, with initial data from all three trials expected in H2 2026 Enrollment ongoing in CLYM116 Phase 1 healthy volunteer study, with initial data expected mid-2026 Strong financial position with cash runway expected into 2028 WELLESLEY HILLS, ...

Dosing completed in Phase 1 study of budoprutug subcutaneous formulation, with data expected in H1 2026 Budoprutug clinical trials ongoing in pMN, ITP, and SLE, with initial data from all three trials expected in H2 2026 Enrollment ongoing in CLYM116 Phase 1 healthy volunteer study, with initial data expected mid-2026 Strong financial position with cash runway expected into 2028 WELLESLEY HILLS, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company ...

Climb Bio FY Conference Summary Company Overview - **Company**: Climb Bio (NasdaqGM:CLYM) - **Focus**: Development of differentiated monoclonal antibody therapeutics for B-cell and autoantibody-driven diseases, particularly immune-mediated diseases [4][5] Key Assets - **Budoprutug**: An anti-CD19 monoclonal antibody targeting primary membranous nephropathy (PMN) and other indications like immune thrombocytopenic purpura (ITP) and lupus [8][20] - **CLYM116**: An anti-APRIL antibody aimed at treating IgA nephropathy (IgAN) [33] Core Points and Arguments Budoprutug - **Mechanism**: Targets CD19, which is expressed on B cells that produce pathogenic antibodies, aiming for B-cell depletion [10][11] - **Clinical Data**: Phase 1b study showed profound B-cell depletion and proteinuria response in 5 evaluable patients, with 60% achieving complete remission [12][13] - **Next Steps**: Enrolling in a Phase 2 study with ascending dose regimens, focusing on B-cell depletion and immunologic response [13][15] - **Subcutaneous (Sub-Q) Formulation**: Development of a Sub-Q formulation is underway, expected to provide more treatment options and convenience for patients [18][19] CLYM116 - **Target**: APRIL, a driver of IgAN biology, with a novel mechanism that captures and depletes APRIL from circulation [37][38] - **Clinical Strategy**: Aiming for improved IgA reduction and proteinuria remission rates compared to existing treatments like Sibeprenlimab [39][40] - **Preclinical Data**: Encouraging results in non-human primates showing better IgA reduction and longer half-life compared to competitors [40] Industry Context - **Market Dynamics**: The treatment landscape for PMN and IgAN is evolving, with increasing interest in B-cell targeting therapies. Climb Bio aims to differentiate itself with its unique assets and formulations [10][34] - **Competitive Landscape**: UPLIZNA is the only approved CD19 inhibitor, and Climb Bio's approach is expected to offer advantages such as a Sub-Q formulation [25][28] Financial and Strategic Outlook - **Funding**: Climb Bio has sufficient cash runway into 2028, with plans to raise additional funds for pivotal trials and new indications [47] - **Clinical Readouts**: Five clinical data readouts expected this year, including Sub-Q data for budoprutug and initial data for CLYM116 [52] Additional Insights - **Unmet Needs**: There is a significant need for new therapies in PMN and ITP, as existing treatments often do not provide durable remission [21][22] - **Combination Strategies**: While currently focusing on monotherapy, there is potential for future combination therapies with other kidney-preserving agents [43][44] Conclusion Climb Bio is positioned to leverage its innovative monoclonal antibody therapies to address significant unmet needs in autoimmune diseases, with promising clinical data and a strategic focus on patient-friendly administration methods. The upcoming clinical readouts will be critical in validating its approach and advancing its market position.

Summary of Climb Bio's Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Autoimmune diseases with two antibodies in clinical development Key Points Upcoming Milestones - Climb Bio has five clinical data readouts scheduled for this year - Monoclonal antibody targeting CD19: - Data on subcutaneous (subQ) formulation in healthy volunteers expected in the first half of the year - Initial data from Phase 1b studies in Immune Thrombocytopenic Purpura (ITP) and Systemic Lupus Erythematosus (SLE) in the second half - Initial data from Phase 2 study in Primary Membranous Nephropathy (PMN) also expected in the second half - Second antibody, an APRIL-only antibody for IgA nephropathy, will have data available mid-year [2][3][4] Competitive Landscape - UPLIZNA is currently the only approved CD19 antibody, focusing on rare neuro diseases - Climb Bio's CD19 antibody is believed to have greater affinity and a subQ formulation option, which UPLIZNA lacks [5][7][11] PMN Indication - No approved therapies currently exist for PMN; standard care includes off-label use of rituximab - Rituximab achieves complete renal remission in only 10% of patients after one year and 35% after two years - Climb Bio's Phase 1b study showed a 60% complete remission rate and 100% serological remission in PLA2R antibody-positive patients [14][15][32] Market Opportunity - Approximately 70,000 patients in the U.S. have PMN, with two-thirds requiring therapeutic intervention - Regulatory strategy involves one Phase 3 study with around 150 patients, focusing on proteinuria as the primary endpoint [32][34] ITP and SLE Indications - ITP has a strong rationale for CD19 targeting, with only 20% of refractory patients achieving a durable platelet response - SLE is viewed as a more complex indication, requiring larger pivotal trials; Climb Bio is conducting a parallel study in China for lupus nephritis patients [39][40][41] APRIL Antibody Development - Climb Bio's APRIL-only antibody (CLYM116) features a unique sweeper mechanism, allowing for high-affinity binding and potential for longer half-life - Early studies indicate a two- to threefold longer half-life compared to existing therapies, with better activity in IgA suppression [48][56][60] Financial Position - Climb Bio reported $176 million in cash at the end of Q3, with a runway extending into 2028, covering all planned readouts for the year [93][95] Future Indications - Climb Bio is exploring additional indications for the APRIL antibody, including Sjögren's syndrome, to maximize asset potential [90][91] Conclusion - Climb Bio is positioned to address significant unmet needs in autoimmune diseases with promising clinical data and a strong financial foundation, paving the way for potential market success in the coming years [2][93][95]

Core Insights - Climb Bio, Inc. has made significant progress in its clinical development programs for budoprutug and CLYM116, with multiple trials ongoing and initial data expected in 2026 [2][3][4] Group 1: Budoprutug Program - Budoprutug, an anti-CD19 monoclonal antibody, has initiated a Phase 2 trial in Primary Membranous Nephropathy (pMN) with first patient dosing achieved in November 2025 [4] - The Phase 1b/2a trial in Immune Thrombocytopenia (ITP) is ongoing, focusing on safety, tolerability, and preliminary efficacy [4] - A global Phase 1b trial in Systemic Lupus Erythematosus (SLE) is also underway, with regulatory clearance for a parallel trial in China received in December 2025 [4][11] - Budoprutug has shown long-term control of proteinuria in pMN patients, as presented at the 2025 ASN Kidney Week [4] Group 2: CLYM116 Program - CLYM116, an anti-APRIL monoclonal antibody, has initiated a Phase 1 study in healthy volunteers, with initial data expected in mid-2026 [8][11] - The antibody targets APRIL, a key driver of B-cell activity in autoimmune diseases, and employs a novel mechanism for enhanced efficacy [13] Group 3: Financial Position and Strategic Priorities - Climb Bio maintains a strong financial position, with cash runway expected to extend into 2028 [2][6] - The company has achieved 20 regulatory clearances for clinical trials and activated 45 trial sites globally, indicating robust clinical execution [3] - 2026 is anticipated to be a transformative year with multiple data readouts from ongoing trials, addressing unmet needs in renal and B-cell mediated diseases [3][4]

Core Insights - Climb Bio Inc. (NASDAQ:CLYM) is identified as a promising biotech penny stock, with analysts projecting a price target increase from $9 to $11 while maintaining a Buy rating due to anticipated data readouts in 2026 for its lead asset Budoprutug [1][2] Group 1: Company Overview - Climb Bio is a clinical-stage biotechnology company focused on developing therapies for immune-mediated diseases, primarily through its two main assets: Budoprutug and CLYM116 [2][5] - Budoprutug is an anti-CD19 antibody targeting B-cell mediated diseases, while CLYM116 is an anti-APRIL antibody aimed at treating IgA nephropathy [2] Group 2: Clinical Trials and Data Readouts - The company has initiated the PrisMN Phase 2 trial for Budoprutug in Primary Membranous Nephropathy, with the trial designed to evaluate safety, pharmacokinetics, and preliminary efficacy, aiming for data release in 2026 [3] - A Phase 1 trial for a subcutaneous formulation of Budoprutug is currently ongoing, with initial data expected in the first half of 2026 [3] - Climb Bio is also conducting an open-label Phase 1b/2a trial for Budoprutug in patients with Immune Thrombocytopenia and a Phase 1b trial in Systemic Lupus Erythematosus patients, with preliminary efficacy results anticipated in the second half of 2026 [4]

Core Insights - Climb Bio Inc. (CLYM) is set for a data-rich year in 2026, with study results from its key programs expected to influence its strategic direction and future development phases [1] Drug Candidates - Budoprutug is an anti-CD19 monoclonal antibody designed for potent and durable B cell depletion, with both intravenous (IV) and subcutaneous (SC) administration options. It is being investigated for primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus [2] - CLYM116 is a novel anti-APRIL monoclonal antibody aimed at promoting the degradation of APRIL, targeting B-cell-mediated diseases such as systemic lupus erythematosus, myasthenia gravis, and IgA nephropathy [3] Ongoing Trials & Upcoming Catalysts - A phase 2 study named PrisMN is evaluating Budoprutug's safety and efficacy in adult subjects with primary membranous nephropathy, enrolling 45 subjects and expected to complete in 2027 [4] - A phase 1b/2a study is assessing Budoprutug in immune thrombocytopenia, with initial efficacy data anticipated in the second half of 2026 [6] - A phase 1b study is evaluating Budoprutug in systemic lupus erythematosus, with preliminary efficacy data expected in the second half of 2026 [8] - A phase 1 study for the SC formulation of Budoprutug in healthy volunteers is ongoing, with initial data expected in the first half of 2026 [10] - Regulatory clearance for a phase 1 trial of CLYM116 has been obtained, with dosing expected to start by the end of 2025 and initial data anticipated mid-2026 [10] Financial Position - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $175.8 million, which is sufficient to fund operations through 2027 [11] Company Background - Climb Bio, formerly Eliem Therapeutics, went public on August 10, 2021, under the ticker symbol "ELYM" at an IPO price of $12.50 per share. The company rebranded to Climb Bio, Inc. and changed its ticker symbol to "CLYM" on October 3, 2024, reflecting a strategic focus on immune-mediated diseases [12] - CLYM's stock has traded between $1.05 and $3.25 over the past year, closing at $3.00 on December 12, 2025, representing a 30.43% increase [13]

Summary of Climb Bio Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Development of monoclonal antibodies for autoimmune diseases, specifically targeting CD19 and APRIL Key Milestones and Upcoming Data - **2026**: Significant year for Climb Bio with multiple data readouts expected - **Budoprutug (CD19 monoclonal antibody)**: - Data from subcutaneous (subQ) formulation in healthy volunteers expected in the first half of 2026 - Data for ITP (Immune Thrombocytopenic Purpura) and SLE (Systemic Lupus Erythematosus) in the second half of 2026 - **Climb 116 (anti-APRIL for IgA nephropathy)**: - Healthy volunteer data anticipated mid-2026 - Focus on potential best-in-class assets for rare autoimmune diseases [2][10][27] Differentiation and Market Opportunity - **CD19 Antibody**: - High affinity for CD19, allowing for broader patient access - Only two monoclonal antibodies targeting CD19 in clinical development: Oplinza and Budoprutug - Oplinza has been successful but focuses on rare neurological diseases, leaving a gap in B-cell mediated diseases [4][5][6] - **IgA Nephropathy**: - Approximately 70,000 patients with no approved therapies, presenting a significant commercial opportunity - Current off-label use of Rituximab shows low efficacy (12%-14% complete renal response at 12 months) [10][11][37] Clinical Development Strategy - **Phase Two Study**: Initiated for PMN (Primary Membranous Nephropathy) with guidance on additional milestones forthcoming - **Indication Strategy**: Focus on high unmet needs in ITP and SLE, with a cautious approach to moving forward based on data [7][8][12] - **SLE Program**: Requires significant investment for late-phase development, with a focus on safety and potential immune reset in patients [16][17] Dosing and Formulation - **Dosing Strategy**: Careful selection of doses based on recent learnings from other CD19 programs, aiming for deep B-cell depletion rather than just peripheral suppression [19][21] - **SubQ Formulation**: Expected to be ready for phase three studies across all indications, optimizing patient access and market potential [22][23] Financial Overview - **Cash Position**: $176 million at the end of Q3, providing a runway through 2027, covering all data releases in 2026 [36] Regulatory Path and Study Size - **Regulatory Clarity**: Established path for PMN with a focus on complete renal response as a registrational endpoint - **Study Size**: Approximately 150 patients for PMN, manageable for a company of Climb Bio's size [37][38] Investor Interest - Growing interest in both Budoprutug and Climb 116, with investors recognizing the competitive profiles of both drugs in their respective markets [35]