Climb Bio, Inc(CLYM) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Climb Bio's Q2 2025 highlights include significant clinical trial advancements for budoprutug and CLYM116, alongside key leadership appointments, setting the stage for future data readouts CEO Statement and Strategic Focus Climb Bio's CEO highlighted the company's focused execution, team building, and pipeline advancement, particularly noting patient dosing in ITP and SLE trials, regulatory clearance for pMN and subcutaneous budoprutug trials, and significant progress with CLYM116, setting the stage for a data-rich period - Patients have been dosed in both the ITP and SLE clinical trials of budoprutug, an anti-CD19 monoclonal antibody[3] - Regulatory clearance was achieved for the pMN Phase 2 trial and the Phase 1 trial of subcutaneous budoprutug in healthy volunteers, both expected to begin shortly[3] - CLYM116, a differentiated anti-APRIL antibody, is making exciting progress and is believed to be a best-in-class treatment for IgAN and other indications[3] - An investor event is planned for September 2025 to showcase the CLYM116 program, share supportive preclinical data, and discuss IgAN development plans[3] Second Quarter 2025 and Recent Highlights The second quarter of 2025 saw significant advancements in Climb Bio's clinical pipeline, including the initiation of trials for budoprutug in ITP and SLE, progress towards a pMN trial, and the development of a subcutaneous formulation. The CLYM116 program also advanced towards clinical development, alongside a key corporate leadership appointment - Phase 1b/2a immune thrombocytopenia (ITP) trial and Phase 1b systemic lupus erythematosus (SLE) trial for budoprutug achieved First Patient In (FPI) and enrollment is ongoing[4] - Phase 2 primary membranous nephropathy (pMN) trial for budoprutug is on track to initiate in the coming weeks[4] - Budoprutug subcutaneous (SC) formulation demonstrated high bioavailability and favorable tolerability in non-clinical studies; a Phase 1 trial in healthy volunteers is expected to initiate soon, with initial results anticipated in the first half of 2026[5] - CLYM116 is advancing toward clinical development for IgA nephropathy (IgAN), with an IND or CTA submission expected in the second half of 2025[6] - Edgar D. Charles, M.D., MSc was appointed Chief Medical Officer in June 2025[7] Pipeline Program Updates Climb Bio's pipeline is advancing with budoprutug trials in ITP, SLE, and pMN, a new subcutaneous formulation, and CLYM116 progressing towards clinical development for IgAN Budoprutug Program Updates Climb Bio provided updates on its budoprutug program, an anti-CD19 monoclonal antibody, detailing the ongoing clinical trials for ITP and SLE, the imminent initiation of a pMN trial, and the successful non-clinical development of a subcutaneous formulation Immune Thrombocytopenia (ITP) Trial The Phase 1b/2a clinical trial for budoprutug in ITP patients is ongoing, evaluating safety, pharmacokinetics, and preliminary efficacy including B cell depletion and platelet counts - The Phase 1b/2a open-label, dose-escalation clinical trial of budoprutug in ITP patients has achieved FPI and enrollment is ongoing[4] - The trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts[4] Systemic Lupus Erythematosus (SLE) Trial The Phase 1b clinical trial for budoprutug in SLE patients is enrolling, assessing safety, pharmacokinetics, and preliminary efficacy, including B cell depletion and autoantibody levels - The Phase 1b open-label, dose-escalation clinical trial of budoprutug in SLE patients has achieved FPI and enrollment is ongoing[4] - The trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion, autoantibody levels, and clinical activity[4] Primary Membranous Nephropathy (pMN) Trial The Phase 2 pMN trial for budoprutug is set to begin soon, evaluating safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including remission rates - The Phase 2 pMN trial, an open-label, dose-ranging study, is on track to initiate in the coming weeks[4] - The trial is designed to evaluate safety, pharmacokinetics, pharmacodynamics (including B cell depletion and anti-PLA2R antibody levels), and preliminary efficacy (including complete and partial remission)[4] Subcutaneous (SC) Formulation Development Budoprutug's subcutaneous formulation shows high bioavailability and favorable tolerability in non-clinical data, with a Phase 1 trial in healthy volunteers expected to start soon - Supportive non-clinical data for budoprutug SC formulation demonstrated high bioavailability and favorable tolerability[5] - A Clinical Trial Application was cleared in Australia in August, and a Phase 1 trial in healthy volunteers is expected to initiate in the coming weeks[5] - Initial Phase 1 trial results for the budoprutug SC formulation are expected in the first half of 2026[5] CLYM116 Program Updates Climb Bio's CLYM116 program, an anti-APRIL antibody for IgA nephropathy (IgAN), is progressing towards clinical development with an IND or CTA submission anticipated in the second half of 2025, complemented by an investor event in September 2025 to share preclinical data - CLYM116, an antibody targeting the APRIL pathway for IgA nephropathy (IgAN), is advancing toward clinical development[6] - Climb Bio remains on track to submit an Investigational New Drug (IND) or Clinical Trial Application (CTA) for CLYM116 in IgAN in the second half of 2025[6] - A CLYM116-focused investor event is planned for September 2025 to share preclinical data, including head-to-head data in nonhuman primates with a first-generation anti-APRIL[6] Corporate Developments Climb Bio strengthened its leadership with the appointment of a new Chief Medical Officer, bringing extensive experience in immunology-focused pharmaceutical development Chief Medical Officer Appointment Climb Bio strengthened its leadership team by appointing Edgar D. Charles, M.D., MSc as Chief Medical Officer in June 2025, leveraging his extensive experience in immunology-focused pharmaceutical development from previous roles at Bristol Myers Squibb and Merck & Co - Edgar D. Charles, M.D., MSc was appointed Chief Medical Officer in June 2025[7] - Dr. Charles brings over 20 years of experience in immunology-focused pharmaceutical development, academic research, and clinical medicine[7] - He previously held significant clinical roles at Bristol Myers Squibb (BMS), leading immunology global program organization, and at Merck & Co., leading global clinical development programs[7] Anticipated Milestones & Financial Summary Climb Bio anticipates key clinical and regulatory milestones for budoprutug and CLYM116 in H2 2025 and H1 2026, supported by a strong cash position extending through 2027 Anticipated Milestones Climb Bio outlined key upcoming milestones for its budoprutug and CLYM116 programs, including trial initiations, data readouts, and regulatory submissions, primarily concentrated in the second half of 2025 and first half of 2026 - Budoprutug (anti-CD19 monoclonal antibody) milestones[11] - pMN Phase 2 study – first patient in (H2 2025)[11] - Company to provide guidance on the anticipated timing of clinical readouts in SLE and ITP (H2 2025)[11] - Subcutaneous formulation Phase 1 clinical trial in healthy volunteers – first patient in (H2 2025) and initial results (H1 2026)[11] - CLYM116 (anti-APRIL monoclonal antibody) milestones[11] - Reporting preclinical data (September 2025) and submission of IND or CTA in IgAN (H2 2025)[11] - Investor event on CLYM116 to be held in September 2025[11] Second Quarter 2025 Financial Highlights Climb Bio reported a strong cash position expected to fund operations through 2027, alongside increased R&D and G&A expenses for Q2 2025 compared to the prior year, while net loss significantly decreased due to the absence of acquired IPR&D expenses - Cash, cash equivalents and marketable securities were $187.4 million as of June 30, 2025, expected to fund operations through 2027[11] Operating Expenses and Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :------------- | | Research and Development (R&D) | $6,575 | $1,046 | +$5,529 | | Acquired In-Process R&D | $0 | $51,659 | -$51,659 | | General and Administrative (G&A) | $4,102 | $3,667 | +$435 | | Other income, net | $2,011 | $1,483 | +$528 | | Net Loss | $(8,666) | $(54,889) | +$46,223 | | Net loss per share, basic and diluted | $(0.13) | $(1.81) | +$1.68 | About Climb Bio and Product Information Climb Bio is a clinical-stage biotech company focused on immune-mediated diseases, developing budoprutug (anti-CD19) and CLYM116 (anti-APRIL) with distinct mechanisms of action Company Profile Climb Bio, Inc. is a clinical-stage biotechnology company dedicated to developing therapeutics for patients with immune-mediated diseases, with a pipeline featuring budoprutug and CLYM116 - Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases[10] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody[10] About Budoprutug Budoprutug is a clinical-stage anti-CD19 monoclonal antibody designed to deplete B cells, targeting a broad range of B-cell mediated immune diseases, with ongoing trials in pMN, ITP, and SLE, and a subcutaneous formulation under development to enhance patient access - Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody developed to address a broad range of B-cell mediated, immune-driven diseases[12] - It targets and depletes CD19-expressing B cells, including plasma blasts, which are key sources of pathogenic autoantibodies[12] - Climb Bio plans to evaluate budoprutug in multiple clinical trials across three lead indications: primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE)[12] - Early clinical data suggest durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN[12] - A subcutaneous formulation is in development to enable broader patient access and potential home-based dosing, and it has been granted orphan drug designation by the FDA for pMN[12] About CLYM116 CLYM116 is a preclinical-stage anti-APRIL monoclonal antibody with a novel pH-dependent mechanism, designed for potent, durable inhibition of APRIL with less frequent dosing, primarily being advanced for IgA nephropathy (IgAN) with potential for broader utility - CLYM116 is a preclinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases[13] - It employs a novel pH-dependent bind-and-release mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL, and recycle the antibody to extend its half-life[13] - This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL with a favorable safety profile and less frequent dosing[13] - CLYM116 is being advanced for the treatment of IgA nephropathy (IgAN), with plans to initiate a Phase 1 clinical trial following IND-enabling studies and regulatory clearance[13] Financial Statements Climb Bio's financial statements for Q2 2025 reflect a reduced net loss compared to the prior year, primarily due to the absence of acquired IPR&D expenses, alongside a decrease in cash and total assets Condensed Consolidated Balance Sheets The condensed consolidated balance sheets show Climb Bio's financial position as of June 30, 2025, reflecting a decrease in cash, cash equivalents, and marketable securities, leading to a reduction in total assets and stockholders' equity compared to December 31, 2024, while total liabilities slightly increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash, cash equivalents and marketable securities | $187,405 | $212,529 | -$25,124 | | Other assets | $4,981 | $4,658 | +$323 | | Total assets | $192,386 | $217,187 | -$24,801 | | Liabilities | $6,622 | $5,306 | +$1,316 | | Total stockholders' equity | $185,764 | $211,881 | -$26,117 | | Total liabilities and stockholders' equity | $192,386 | $217,187 | -$24,801 | Condensed Consolidated Statements of Operations Climb Bio's statements of operations for Q2 2025 show a significant decrease in net loss compared to Q2 2024, primarily due to the absence of a large acquired in-process R&D expense from the prior year, despite an increase in ongoing R&D and G&A expenses Condensed Consolidated Statements of Operations (Three Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $6,575 | $1,046 | +$5,529 | | Acquired in-process research and development | $0 | $51,659 | -$51,659 | | General and administrative | $4,102 | $3,667 | +$435 | | Total operating expenses | $10,677 | $56,372 | -$45,695 | | Loss from operations | $(10,677) | $(56,372) | +$45,695 | | Other income, net | $2,011 | $1,483 | +$528 | | Net loss | $(8,666) | $(54,889) | +$46,223 | | Net loss per share, basic and diluted | $(0.13) | $(1.81) | +$1.68 | Condensed Consolidated Statements of Operations (Six Months Ended June 30, in thousands, except per share amounts) | Metric | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $23,902 | $2,137 | +$21,765 | | Acquired in-process research and development | $0 | $51,659 | -$51,659 | | General and administrative | $9,793 | $5,581 | +$4,212 | | Total operating expenses | $33,695 | $59,377 | -$25,682 | | Loss from operations | $(33,695) | $(59,377) | +$25,682 | | Other income, net | $4,248 | $2,791 | +$1,457 | | Net loss | $(29,447) | $(56,586) | +$27,139 | | Net loss per share, basic and diluted | $(0.44) | $(1.95) | +$1.51 | Legal and Contact Information This section provides important disclaimers regarding forward-looking statements, highlighting inherent risks and uncertainties, and offers contact details for investor and media inquiries Forward-Looking Statements This section serves as a cautionary note, indicating that the press release contains forward-looking statements subject to various risks and uncertainties that could cause actual results to differ materially from expectations, and Climb Bio disclaims any obligation to update these statements unless legally required - The press release contains "forward-looking statements" regarding future expectations, plans, and prospects for Climb Bio, including therapeutic benefits, clinical development, trial timelines, and financial resources[14] - These statements are subject to risks and uncertainties that could cause actual results to differ materially, including those related to acquisitions, regulatory changes, competition, intellectual property, expense management, and capital raising[14] - Climb Bio specifically disclaims any obligation to update these forward-looking statements, except as required by law[14] Investors and Media Contact Contact information is provided for investors and media inquiries, directing them to Carlo Tanzi, Ph.D. at Kendall Investor Relations - For investor and media inquiries, contact Carlo Tanzi, Ph.D. at Kendall Investor Relations[15] - Email: ctanzi@kendallir.com[15]