First patients dosed in budoprutug PrisMN Phase 2 trial in pMN, with initial data expected second half 2026 Dosing ongoing in budoprutug Phase 1b/2a trial in ITP and Phase 1b trial in SLE; achieved regulatory clearance for SLE IND in China First patients dosed in CLYM116 Phase 1 healthy volunteer study Anticipating a data-rich 2026, with initial readouts from all ongoing budoprutug and CLYM116 studies Strong financial position with cash runway expected into 2028 WELLESLEY HILLS, Mass., Jan. 08, 2026 (GLOB ...

Climb Bio Inc. (NASDAQ:CLYM) is one of the best biotech penny stocks to buy according to analysts. On December 18, H.C. Wainwright analyst Raghuram Selvaraju raised the firm’s price target on Climb Bio to $11 from $9, while maintaining a Buy rating on the shares. This sentiment was announced as the firm believes that Budoprutug’s progress across clinical tracks will culminate in the release of data readouts during 2026. The company is currently focused on two primary assets: Budoprutug, which is an anti- ...

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]

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].