Climb Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
Climb Bio (NASDAQ: CLYM) reported its Q1 2025 financial results and provided key business updates. The company's lead program budoprutug, an anti-CD19 monoclonal antibody, is advancing with FDA clearances for clinical trials in multiple indications. Clinical studies for ITP and SLE are set to begin in H1 2025, followed by pMN trials in H2 2025.
The company expanded its pipeline with CLYM116, an anti-APRIL monoclonal antibody licensed from Mabworks for IgA nephropathy treatment. Climb Bio strengthened its leadership by appointing two new independent directors and a Chief Business Officer. Financially, the company reported $197.8 million in cash and equivalents, expected to fund operations through 2027. R&D expenses increased to $17.3 million in Q1 2025, including a $9.0 million upfront payment to Mabworks.
Climb Bio (NASDAQ: CLYM) ha comunicato i risultati finanziari del primo trimestre 2025 e fornito aggiornamenti chiave sul business. Il programma principale dell'azienda, budoprutug, un anticorpo monoclonale anti-CD19, sta avanzando con approvazioni FDA per trial clinici in più indicazioni. Gli studi clinici per ITP e SLE inizieranno nella prima metà del 2025, seguiti dai trial per pMN nella seconda metà del 2025.
L'azienda ha ampliato il proprio portafoglio con CLYM116, un anticorpo monoclonale anti-APRIL concesso in licenza da Mabworks per il trattamento della nefrite da IgA. Climb Bio ha rafforzato il proprio management nominando due nuovi direttori indipendenti e un Chief Business Officer. Dal punto di vista finanziario, la società ha riportato 197,8 milioni di dollari in liquidità e equivalenti, previsti per finanziare le operazioni fino al 2027. Le spese in R&S sono aumentate a 17,3 milioni di dollari nel primo trimestre 2025, inclusi 9,0 milioni di dollari di pagamento anticipato a Mabworks.
Climb Bio (NASDAQ: CLYM) informó sus resultados financieros del primer trimestre de 2025 y proporcionó actualizaciones clave del negocio. El programa principal de la compañía, budoprutug, un anticuerpo monoclonal anti-CD19, avanza con aprobaciones de la FDA para ensayos clínicos en múltiples indicaciones. Los estudios clínicos para ITP y LES comenzarán en la primera mitad de 2025, seguidos por ensayos para pMN en la segunda mitad de 2025.
La empresa amplió su cartera con CLYM116, un anticuerpo monoclonal anti-APRIL licenciado de Mabworks para el tratamiento de la nefropatía por IgA. Climb Bio fortaleció su liderazgo nombrando dos nuevos directores independientes y un Chief Business Officer. En cuanto a finanzas, la compañía reportó 197,8 millones de dólares en efectivo y equivalentes, que se espera financien las operaciones hasta 2027. Los gastos en I+D aumentaron a 17,3 millones de dólares en el primer trimestre de 2025, incluyendo un pago inicial de 9,0 millones a Mabworks.
Climb Bio (NASDAQ: CLYM)은 2025년 1분기 재무 실적을 보고하고 주요 사업 업데이트를 발표했습니다. 회사의 주요 프로그램인 budoprutug는 항-CD19 단일클론 항체로, 여러 적응증에 대한 임상 시험을 위해 FDA 승인을 받고 있습니다. ITP 및 SLE 임상 시험은 2025년 상반기 시작되며, pMN 시험은 2025년 하반기 예정입니다.
회사는 Mabworks로부터 라이선스 받은 IgA 신병증 치료용 항-APRIL 단일클론 항체 CLYM116으로 파이프라인을 확장했습니다. Climb Bio는 두 명의 신규 독립 이사와 최고사업책임자를 임명하여 리더십을 강화했습니다. 재무적으로는 1억 9,780만 달러의 현금 및 현금성 자산을 보고했으며, 이는 2027년까지 운영 자금을 지원할 것으로 예상됩니다. 2025년 1분기 연구개발 비용은 1,730만 달러로 증가했으며, 이 중 900만 달러는 Mabworks에 대한 선불금입니다.
Climb Bio (NASDAQ : CLYM) a publié ses résultats financiers du premier trimestre 2025 et fourni des mises à jour clés sur ses activités. Le programme principal de la société, budoprutug, un anticorps monoclonal anti-CD19, progresse avec des autorisations de la FDA pour des essais cliniques dans plusieurs indications. Les études cliniques pour l’ITP et le LES débuteront au premier semestre 2025, suivies des essais pour pMN au second semestre 2025.
L’entreprise a élargi son portefeuille avec CLYM116, un anticorps monoclonal anti-APRIL sous licence de Mabworks pour le traitement de la néphropathie à IgA. Climb Bio a renforcé sa direction en nommant deux nouveaux administrateurs indépendants et un Chief Business Officer. Sur le plan financier, la société a déclaré 197,8 millions de dollars en liquidités et équivalents, prévus pour financer les opérations jusqu’en 2027. Les dépenses de R&D ont augmenté à 17,3 millions de dollars au premier trimestre 2025, incluant un paiement initial de 9,0 millions à Mabworks.
Climb Bio (NASDAQ: CLYM) veröffentlichte seine Finanzergebnisse für das erste Quartal 2025 und gab wichtige Geschäftsinformationen bekannt. Das Hauptprogramm des Unternehmens, budoprutug, ein anti-CD19 monoklonaler Antikörper, schreitet mit FDA-Zulassungen für klinische Studien in mehreren Indikationen voran. Klinische Studien für ITP und SLE sollen in der ersten Hälfte 2025 beginnen, gefolgt von pMN-Studien in der zweiten Hälfte 2025.
Das Unternehmen erweiterte seine Pipeline um CLYM116, einen anti-APRIL monoklonalen Antikörper, der von Mabworks für die Behandlung der IgA-Nephropathie lizenziert wurde. Climb Bio stärkte seine Führungsebene durch die Ernennung von zwei neuen unabhängigen Direktoren und einem Chief Business Officer. Finanzbericht: Das Unternehmen meldete 197,8 Millionen US-Dollar an liquiden Mitteln und Äquivalenten, die voraussichtlich den Betrieb bis 2027 finanzieren. Die F&E-Ausgaben stiegen im ersten Quartal 2025 auf 17,3 Millionen US-Dollar, einschließlich einer Vorauszahlung von 9,0 Millionen US-Dollar an Mabworks.
- Strong cash position of $197.8 million with runway through 2027
- FDA clearances received for multiple clinical trials of budoprutug
- Pipeline expansion with CLYM116 licensing agreement
- Strategic leadership appointments strengthening the board and management team
- Significant increase in R&D expenses to $17.3 million from $1.1 million YoY
- Higher G&A expenses at $5.7 million compared to $1.9 million YoY
Insights
Climb Bio shows promising pipeline progress with multiple clinical trials initiating in 2025, supported by a solid $197.8M cash runway through 2027.
Climb Bio's Q1 2025 results reveal a company executing efficiently on multiple clinical programs while maintaining financial discipline. The company's lead asset, budoprutug (anti-CD19 monoclonal antibody), has achieved significant regulatory milestones with FDA clearances for clinical trials in three indications: primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). This represents strong validation of the program's potential and positions the company for multiple value-creating catalysts through 2025.
The cash position of
R&D expenses increased substantially to
The licensing of CLYM116, targeting the APRIL pathway for IgA nephropathy, represents a strategic expansion of their pipeline beyond CD19-targeting therapies. This diversification reduces clinical risk while maintaining focus on B-cell mediated autoimmune diseases, where mechanism overlap can create development efficiencies.
Management additions are also noteworthy, particularly Bo Cumbo, who brings commercial launch experience across 11 specialty/rare disease therapies. This suggests forward planning for potential commercialization, though this remains years away. The appointment of an experienced CBO further indicates potential business development activity ahead.
The company's focus on subcutaneous formulation development for budoprutug is strategically sound, as this could provide significant competitive advantages in chronic autoimmune conditions where administration convenience directly impacts patient compliance and quality of life.
Climb Bio's anti-CD19 and anti-APRIL antibodies target B-cell pathways, potentially offering new options for patients with autoimmune diseases resistant to existing therapies.
Climb Bio's pipeline demonstrates a focused immunological approach targeting key B-cell pathways across multiple autoimmune conditions. Their lead candidate budoprutug, an anti-CD19 monoclonal antibody, represents an interesting mechanistic approach that differentiates from the broader B-cell depletion seen with rituximab (anti-CD20). CD19 is expressed earlier in B-cell development and persists on plasmablasts after CD20 expression is lost, potentially offering more complete B-cell modulation while preserving some plasma cells required for maintaining protective immunity.
The indication selection for budoprutug is scientifically sound and commercially strategic. Primary membranous nephropathy (pMN) is mediated by autoantibodies against PLA2R expressed by podocytes, making B-cell targeted therapy mechanistically rational. Similarly, both ITP and SLE involve pathogenic autoantibody production and B-cell dysregulation, providing strong biological rationales for anti-CD19 intervention. The overlapping B-cell pathology across these conditions enables efficient clinical development while addressing substantial unmet medical needs.
Their newer asset CLYM116 targets APRIL (A Proliferation-Inducing Ligand), which stimulates B-cell maturation and survival. The differentiated pH-dependent mechanism described suggests potential advantages over other APRIL-targeting approaches in development. For IgA nephropathy specifically, APRIL signaling contributes to the production of galactose-deficient IgA1 and subsequent immune complex formation, making this a mechanistically validated target.
The development of a subcutaneous formulation for budoprutug addresses a key limitation of many biologics in autoimmune diseases. Self-administered subcutaneous dosing significantly improves treatment burden compared to intravenous infusions, potentially enabling more consistent therapy adherence and better outcomes in chronic conditions.
While promising, significant clinical hurdles remain. Balancing effective B-cell inhibition while avoiding severe immunosuppression will be critical. The initiated trials will need to demonstrate not just efficacy but acceptable safety profiles, particularly regarding infection risk and long-term immunological consequences of B-cell modulation. The development timeline remains appropriate, with the company prudently waiting for enrollment dynamics before committing to specific clinical readout timelines.
Clinical Trials of Budoprutug in Primary Membranous Nephropathy (pMN), Immune Thrombocytopenia (ITP), and Systemic Lupus Erythematosus (SLE) on Track to Initiate in 2025
CLYM116 Progressing Towards Anticipated IND or CTA Submission in Second Half 2025
Appointed Kim Cobleigh Drapkin, CPA, and Bo Cumbo as Independent Directors and Perrin Wilson, Ph.D., as Chief Business Officer
Strong Financial Position, with Cash Runway Expected Through 2027
WELLESLEY HILLS, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the first quarter ended March 31, 2025, and provided business updates.
“2025 is a critical year of execution for Climb Bio and we continue to make excellent progress developing a differentiated pipeline targeting immune-mediated diseases with expansive therapeutic and commercial potential,” said Aoife Brennan, President and CEO of Climb Bio. “Our most advanced program, budoprutug, a potential best-in-class anti-CD19 monoclonal antibody designed to treat B-cell mediated diseases, remains on track to initiate clinical studies in ITP and SLE in the coming weeks and in pMN in the second half of 2025. We plan to provide clarity on the anticipated timing of clinical readouts later this year when enrollment dynamics are clearer. In parallel, we are advancing the subcutaneous formulation of budoprutug and subject to regulatory clearance, anticipate initiating a Phase 1 clinical trial in healthy volunteers in the second half of the year.”
Dr. Brennan continued, “We have also made progress with our CLYM116 program, a potential best-in-class anti-APRIL monoclonal antibody with potential to provide therapeutic benefit to patients living with IgA nephropathy and other B-cell mediated diseases. We look forward to sharing detailed preclinical data from the program, including pharmacokinetic and pharmacodynamic markers of biological activity, in the second half of 2025 and we anticipate submitting an investigational new drug (IND) or clinical trial application (CTA) for CLYM116 by year end.”
First Quarter 2025 and Recent Highlights
- FDA clearance for budoprutug Phase 2 pMN clinical trial. In March 2025, the Company announced that it had received clearance from the FDA to initiate a Phase 2 clinical trial of budoprutug in patients with pMN. This open-label, dose-ranging trial is designed to further evaluate the efficacy and safety of budoprutug in pMN.
- FDA clearance of budoprutug IND in ITP. In March 2025, the Company announced that it had received clearance from the FDA of its IND to initiate a Phase 1b/2a clinical trial of budoprutug in patients with ITP. In parallel, the Company is also pursuing ex-U.S. regulatory clearance for this clinical trial. This open-label, dose escalation and expansion trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of budoprutug in ITP.
- Pursuing ex-U.S. regulatory clearance for budoprutug clinical trial in SLE. Following the Company’s receipt of clearance from the FDA of its IND for SLE, the Company is also pursuing regulatory clearance to initiate the Phase 1b clinical trial of budoprutug in SLE at sites outside the United States. The open-label, single ascending dose study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical efficacy of budoprutug in SLE.
- Completed studies supporting a cell line switch for budoprutug. In March 2025, the Company announced that it was advancing the productivity and scalability of the manufacturing process for budoprutug to support later-stage clinical development.
- Expanded pipeline to include CLYM116, an antibody targeting the APRIL pathway for IgAN. In January 2025, Climb Bio entered into a technology transfer and exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (Mabworks) for the rights to develop and commercialize CLYM116 in the territory outside of Greater China. CLYM116 is a highly potent, Fc-engineered antibody that has the potential to enable more rapid, deep, and durable inhibition of APRIL signaling through its novel, pH-dependent mechanism of action. CLYM116 is currently in IND-enabling studies and the Company anticipates submitting an IND or CTA by year end.
- Appointed Kim Cobleigh Drapkin, CPA, and Bo Cumbo as Independent Directors in April 2025. Kim Cobleigh Drapkin, CPA, is a seasoned financial leader with over 30 years of experience guiding private and publicly traded biotechnology and pharmaceutical companies through strategic growth, financial planning, capital raises, and transformative transactions. Ms. Drapkin most recently served as Chief Executive Officer of Graphite Bio. Bo Cumbo brings over 30 years of experience in the pharmaceutical and biotechnology industries, with a proven track record of leading successful commercial launches for 11 specialty and rare disease therapies. Mr. Cumbo currently serves as President, Chief Executive Officer, and Director of Solid Biosciences.
- Appointed Perrin Wilson, Ph.D., as Chief Business Officer in February 2025. Dr. Wilson has over 17 years of experience in the pharmaceutical and biotech industry and has deep expertise in business development and commercial strategy. During her career, she has led brand strategy and launch preparations and has overseen multiple successful acquisitions and integrations.
Anticipated Milestones
- Budoprutug (anti-CD19 monoclonal antibody):
- ITP Phase 1b/2a study - first patient in (H1 2025)
- SLE Phase 1b study - first patient in (H1 2025)
- pMN Phase 2 study - first patient in (H2 2025)
- Subcutaneous formulation - obtain additional non-clinical data (H1 2025) and initiation of a Phase 1 clinical trial in healthy volunteers (H2 2025)
- CLYM116 (anti-APRIL monoclonal antibody):
- Reporting preclinical data (H2 2025) and submission of IND or CTA (H2 2025)
- Reporting preclinical data (H2 2025) and submission of IND or CTA (H2 2025)
First Quarter 2025 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$197.8 million as of March 31, 2025. Cash, cash equivalents and marketable securities are expected to fund operations through 2027. - Research and Development (R&D) expenses: R&D expenses were
$17.3 million for the three months ended March 31, 2025, including the$9.0 million upfront payment made to Mabworks in accordance with the license agreement, compared to$1.1 million for the comparable period in 2024. - General and Administrative (G&A) expenses: G&A expenses were
$5.7 million for the three months ended March 31, 2025, compared to$1.9 million for the comparable period in 2024. - Other income, net: Other income, net was
$2.2 million for the three months ended March 31, 2025, compared to$1.3 for the comparable period in 2024.
About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy. For more information, please visit climbbio.com.
About Budoprutug
Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody being developed by Climb Bio to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasma blasts that are key sources of pathogenic autoantibodies. 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)—which represent distinct mechanistic subtypes of immune-mediated disease. Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN. A subcutaneous formulation is also in development to enable broader patient access and potential home-based dosing. Budoprutug has been granted orphan drug designation by the FDA for the treatment of pMN.
About CLYM116
CLYM116 is a preclinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases. CLYM116 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. This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL with a favorable safety profile and less frequent dosing. CLYM116 is being advanced for the treatment of IgA nephropathy (IgAN), with plans to initiate a Phase 1 clinical trial following completion of IND-enabling studies and subject to regulatory clearance. The molecule may also have broader utility across other B-cell mediated diseases where APRIL plays a critical role.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; the trial design for the planned clinical trials of budoprutug; the anticipated timelines for initiating clinical trials of budoprutug for primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus; plans to optimize the administration of budoprutug; the anticipated benefits of Climb Bio’s license agreement with Mabworks; expectations regarding the timing of an investigational new drug application or clinical trial application submission for CLYM116; the sufficiency of Climb Bio’s cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its acquisition of Tenet Medicines, Inc. and its license agreement with Mabworks; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.
Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
| Climb Bio, Inc. | ||||||||
| Condensed Consolidated Balance Sheets (In thousands) (unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Cash, cash equivalents, and marketable securities | $ | 197,845 | $ | 212,529 | ||||
| Other assets | 2,895 | 4,658 | ||||||
| Total assets | $ | 200,740 | $ | 217,187 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Liabilities | $ | 7,355 | $ | 5,306 | ||||
| Total stockholders’ equity | 193,385 | 211,881 | ||||||
| Total liabilities and stockholders’ equity | $ | 200,740 | $ | 217,187 | ||||
| Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | 17,327 | 1,091 | ||||||
| General and administrative | 5,691 | 1,914 | ||||||
| Total operating expenses | $ | 23,018 | $ | 3,005 | ||||
| Loss from operations | (23,018 | ) | (3,005 | ) | ||||
| Other income, net | 2,237 | 1,308 | ||||||
| Net loss | $ | (20,781 | ) | $ | (1,697 | ) | ||
| Net loss per share, basic and diluted | $ | (0.31 | ) | $ | (0.06 | ) | ||
FAQ
What is the cash runway for Climb Bio (CLYM) as of Q1 2025?
What are the main clinical trial milestones for CLYM's budoprutug in 2025?
How did Climb Bio's R&D expenses change in Q1 2025 compared to Q1 2024?
What is CLYM116 and when is its expected IND submission?
Who are the new board members appointed to Climb Bio in 2025?
