Climb Bio (NasdaqGM:CLYM) FY Conference December 02, 2025 09:30 AM ET Company ParticipantsNone - Company RepresentativeConference Call ParticipantsYaz Rahimi - Biotech AnalystYaz RahimiGood morning, everyone. Welcome to our first day of our Piper Sandler Healthcare Conference. My name is Yaz Rahimi. I'm a Biotech Analyst here at Piper Sandler. Excited to have Climb Bio with us. I cannot believe 2025 flew by. We're heading into 2026. 2026 is a very big year for Climb Bio. Maybe a good place to start off is j ...

Financial Performance - Climb Bio, Inc. reported net losses of $12.9 million and $42.3 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $272.2 million[99]. - Net loss for the three months ended September 30, 2025, was $12.9 million, compared to a net loss of $8.9 million for the same period in 2024, reflecting an increase of $3.9 million[118]. - Total operating expenses for the nine months ended September 30, 2025, were $48.6 million, a decrease of $22.5 million from $71.1 million in the same period in 2024[124]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $38.7 million, compared to $10.0 million in the same period in 2024[132]. - Research and development expenses for the nine months ended September 30, 2025, were $33.0 million, up from $8.4 million in 2024, primarily due to increased costs for the budoprutug and CLYM116 programs[125]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $4.5 million to $15.6 million, largely due to a $3.1 million rise in personnel-related expenses[127]. Clinical Development - The company received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN), where 60% of patients in a prior trial achieved complete remission of proteinuria[93]. - Climb Bio is also advancing budoprutug in clinical trials for immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE), with initial data expected in the second half of 2026 for both indications[94][95]. - The company is developing CLYM116, an anti-APRIL monoclonal antibody, which has shown improved bioavailability and prolonged exposure compared to a first-generation counterpart[97]. - The company has paused the development of its Kv7 program, previously focused on neuronal excitability disorders, while seeking a partner for further development[98]. Acquisitions and Agreements - The company acquired Tenet Medicines, Inc. for $41.9 million in common stock, with total acquisition costs amounting to $52.8 million, including transaction costs[103]. - Climb Bio entered into the Mabworks Agreement, making an upfront payment of $9.0 million for rights to develop CLYM116 outside Greater China, with additional milestone payments expected[104]. - The company has obligations under an asset purchase agreement with Acelyrin, which includes milestone and royalty payments contingent on future events[145]. Financial Position and Funding - Climb Bio's cash, cash equivalents, and marketable securities are estimated to fund operations through 2027, but future financing may be required if capital resources are depleted sooner than anticipated[102]. - The company believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations through 2027[139]. - Future funding requirements will depend on various factors, including the costs and progress of clinical trials for product candidates like budoprutug and CLYM116[142]. - The company may need to finance operations through equity offerings or debt financings, which could dilute stockholder ownership[141]. Expenses and Cost Management - Research and development expenses increased from $6.2 million in Q3 2024 to $9.1 million in Q3 2025, primarily due to a $2.7 million increase in costs for the budoprutug program[119]. - General and administrative expenses rose from $5.5 million in Q3 2024 to $5.8 million in Q3 2025, driven by higher personnel-related expenses of $0.8 million[120]. - The company is subject to risks related to biopharmaceutical development, which may lead to unforeseen expenses and delays[140]. - The company may face inflationary pressures affecting salaries, goods, and transportation costs, impacting overall expenses[142]. - The company has no material minimum purchase commitments in contracts with third parties for clinical trials and manufacturing services[143]. Compliance and Accounting - The company is classified as an emerging growth company and can delay adopting new accounting standards until they apply to private companies[149]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring estimates that could differ materially from actual results[146].

Financial Performance - Climb Bio reported cash, cash equivalents, and marketable securities of $175.8 million as of September 30, 2025, expected to fund operations through 2027[9] - The net loss for Q3 2025 was $12.9 million, compared to a net loss of $8.9 million in Q3 2024, reflecting a 45.0% increase in losses[9] - Total operating expenses for Q3 2025 were $14.9 million, compared to $11.7 million in Q3 2024, marking a 27.5% increase[9] Research and Development - Research and Development (R&D) expenses for Q3 2025 were $9.1 million, up from $6.2 million in Q3 2024, representing a 46.8% increase[9] - Climb Bio initiated the Phase 2 trial of budoprutug in Primary Membranous Nephropathy (pMN) and expects dosing to start in the coming weeks[3] - Initial data from the Phase 1 trial of budoprutug's subcutaneous formulation is anticipated in H1 2026[1] - Climb Bio expects to announce initial data from ongoing trials for Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) in H2 2026[4] - CLYM116, targeting IgA nephropathy, received regulatory clearance for a Phase 1 trial, with the first subject expected to be dosed by year-end 2025[5] Administrative Changes - General and Administrative (G&A) expenses for Q3 2025 were $5.8 million, compared to $5.5 million in Q3 2024, a 5.5% increase[9] - The company appointed new leadership, including Susan Altschuller as Chief Financial Officer, enhancing its organizational strength[9]

Core Insights - Climb Bio, Inc. has initiated a Phase 2 trial of budoprutug for Primary Membranous Nephropathy (pMN) and expects to advance its clinical programs significantly in 2026 [1][2] - The company has strengthened its leadership team with key appointments to enhance operational capabilities [1][11] - Financial results indicate a cash position that is expected to sustain operations through 2027, allowing for continued development of its clinical pipeline [1][8] Budoprutug Program Updates - The Phase 2 trial, named 'PrisMN,' has been initiated in multiple countries, focusing on safety, pharmacokinetics, and preliminary efficacy [5] - A Phase 1 trial of a subcutaneous formulation of budoprutug is ongoing, with initial data expected in H1 2026 [1][5] - Ongoing trials for budoprutug in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) are expected to yield initial data in H2 2026 [1][5] CLYM116 Program Updates - CLYM116, targeting the APRIL pathway for IgA nephropathy, has received regulatory clearance for a Phase 1 trial, with dosing anticipated by year-end 2025 [1][6] - Initial data from the CLYM116 trial is expected in mid-2026, following a recent R&D Spotlight Webcast that highlighted its differentiation from first-generation therapies [6][2] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $175.8 million, expected to fund operations through 2027 [1][11] - Research and Development (R&D) expenses for Q3 2025 were $9.1 million, an increase from $6.2 million in Q3 2024, while General and Administrative (G&A) expenses were $5.8 million, slightly up from $5.5 million in the prior year [8][11]

Core Viewpoint - Climb Bio Inc. (NASDAQ:CLYM) is gaining attention as a promising investment opportunity due to its potential in developing therapies for autoimmune diseases, particularly with its CD19 antibody, budoprutug [1][2]. Group 1: Analyst Ratings - William Blair analyst Matt Phipps initiated coverage of Climb Bio with an Outperform rating, emphasizing the potential of budoprutug for autoimmune indications [1]. - H.C. Wainwright analyst Raghuram Selvaraju also initiated coverage with a Buy rating and set a price target of $9, highlighting Climb Bio as a disruptive innovator in treating B-cell-mediated autoimmune diseases [2]. Group 2: Market Position and Valuation - The valuations of comparable companies suggest significant upside potential for Climb Bio's shares, indicating a favorable market position [2]. - Climb Bio is identified as a clinical-stage biotechnology company focused on therapies for immune-mediated diseases, which positions it well within the biotech sector [3].

Summary of Key Points - Climb Bio, Inc. (NASDAQ:CLYM) is currently trading at $2.32 with a target price of $1.80, indicating a potential downside of approximately -22.41%, reflecting analyst pessimism about its future performance [1][5] - Inovio Pharmaceuticals, Inc. (INO) is trading at $2.47 with a target price of $1.96, showing a potential downside of -20.63%. It has a market cap of $131.26 million and a negative EPS of -2.72, indicating financial challenges similar to Climb Bio [2][5] - Context Therapeutics Inc. (CNTX) has a current price of $1.37 and a target price of $1.61, suggesting a potential upside of 17.72%. It has a market cap of $122.89 million and an EPS of -0.43, presenting a more favorable outlook compared to Climb Bio [3][5] - Inhibikase Therapeutics, Inc. (IKT) is trading at $1.61 with a target price of $2.38, indicating a potential upside of 47.68%. Despite a market cap of $119.60 million, its EPS of -0.04 and P/E ratio of -2.80 suggest a more promising investment opportunity [4][5]

Core Insights - Climb Bio, Inc. has appointed Adam Villa as Senior Vice President of Technical Operations and Ashley Jones as Senior Vice President of People & Workforce Strategy, enhancing its leadership team during a critical growth phase [2][4]. Leadership Appointments - Adam Villa brings over 20 years of experience in biopharmaceutical development and manufacturing, with expertise in technical operations and clinical production scaling. His previous roles include Vice President of CMC at Generation Bio and leadership positions at CRISPR Therapeutics and Biogen [2][3]. - Ashley Jones has nearly 20 years of experience in the biotechnology sector, previously founding Cultivate Co. and holding leadership roles at Ananke Therapeutics, Imara, and SQZ Biotechnologies. She is recognized for building high-performing organizations and fostering collaborative cultures [3][2]. Inducement Equity Awards - Climb Bio granted inducement equity awards to the new executives, consisting of non-statutory stock options to purchase up to 360,000 shares of common stock at an exercise price of $2.32 per share. The options have a ten-year term and vest over four years [4]. Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases. Its pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy [5].

Core Insights - Climb Bio, Inc. is advancing two monoclonal antibodies, CLYM116 for IgA nephropathy and budoprutug for primary membranous nephropathy, with promising preclinical and clinical data to be presented at the 2025 ASN Kidney Week [1][2][3] Group 1: CLYM116 Development - CLYM116 is a novel anti-APRIL monoclonal antibody designed to treat IgA nephropathy, showing favorable pharmacokinetic and pharmacodynamic profiles in preclinical models [1][2] - The antibody promotes APRIL degradation and enhances antibody recycling, leading to significant reductions in IgA levels [2][9] - CLYM116 employs a pH-dependent binding mechanism, potentially allowing for less frequent dosing and a favorable safety profile [9] Group 2: Budoprutug Clinical Data - Budoprutug is an anti-CD19 monoclonal antibody targeting B-cell mediated diseases, with long-term follow-up data from a Phase 1b trial indicating sustained control of proteinuria for up to three years in patients with primary membranous nephropathy [3][7] - In the trial, four patients received up to four doses of budoprutug, with three patients not requiring further immunosuppressive treatment [3] - No significant treatment-related adverse events were reported, supporting further investigation of budoprutug as a potential disease-modifying therapy [3][8] Group 3: Presentation Details - Climb Bio will present CLYM116 data at ASN Kidney Week on November 8, 2025, with a poster titled "Development and Characterization of CLYM116" [5] - The abstract for budoprutug's long-term remission data in primary membranous nephropathy is also available, highlighting its clinical significance [5][4]

Core Viewpoint - Climb Bio, Inc. has appointed Susan Altschuller, Ph.D., MBA, as Chief Financial Officer, enhancing its leadership team to support the advancement of its therapeutic pipeline for immune-mediated diseases [1][2][3] Company Leadership - Susan Altschuller brings over 20 years of strategic and financial leadership experience in the biopharmaceutical sector, having previously served as CFO at Cerevel Therapeutics and ImmunoGen [2][3] - Her expertise includes financial strategy, capital allocation, and operational execution, which will be valuable as Climb Bio progresses with its clinical programs [2][3] Clinical Pipeline - Climb Bio is advancing two key programs: budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy [4] - The company anticipates generating significant clinical data from both programs in the upcoming year, which will inform future strategies [2][3] Inducement Equity Award - In connection with her appointment, Climb Bio granted Dr. Altschuller an inducement equity award consisting of a non-statutory stock option to purchase up to 600,000 shares of common stock, with a ten-year term and a four-year vesting schedule [3]

Climb Bio Investor Event Summary Company Overview - **Company**: Climb Bio (NasdaqGM:CLYM) - **Focus**: Development of Climb 116 for IgA nephropathy treatment Key Industry Insights - **IgA Nephropathy**: A significant cause of end-stage renal disease with over 170,000 patients in the U.S. alone, expected to grow due to updated diagnostic guidelines [8][9] - **Market Opportunity**: IgA nephropathy represents a large and growing commercial opportunity with established regulatory pathways for drug approval [9][10] Core Points and Arguments - **Climb 116 Development**: - Climb 116 is a next-generation anti-APRIL monoclonal antibody, designed to target APRIL, a key player in IgA nephropathy pathogenesis [28][33] - The drug is expected to enter clinical trials later this year, with initial data anticipated by mid-2026 [48][50] - Climb 116 has shown potential for deeper and more durable IgA reductions compared to first-generation therapies [51][52] - **Clinical Strategy**: - Climb Bio's strategy emphasizes rigorous clinical development with a focus on differentiated monoclonal antibodies against validated B-cell targets [5][6] - The company plans to leverage partnerships, such as with Mabwell, to expedite development and commercialization [7][8] - **Preclinical Results**: - Climb 116 demonstrated superior pharmacokinetics (PK) and pharmacodynamics (PD) in non-human primate studies, showing a longer half-life and deeper IgA suppression compared to sibecrilimumab [42][44][46] - The drug's unique "sweeper" mechanism allows for effective recycling and prolonged APRIL suppression, which may lead to improved clinical outcomes [35][36][40] Important but Overlooked Content - **Regulatory Pathway**: The established regulatory precedent for IgA nephropathy treatments supports a streamlined clinical development process for Climb 116 [51] - **Biomarker Utilization**: The use of biomarkers such as proteinuria and IgA levels will guide dose selection and efficacy predictions in clinical trials [49][50] - **Immunogenicity Concerns**: While anti-drug antibodies (ADAs) were observed in non-human primate models, the company has low suspicion of immunogenicity in humans based on historical data [62] Conclusion - Climb Bio is positioned to potentially lead the market in IgA nephropathy treatments with Climb 116, which shows promise for improved efficacy and patient compliance through less frequent dosing and a favorable safety profile [52]