Climb Bio, Inc. Annual Report - A Year in Review for Investors

Discover Climb Bio, Inc.'s performance for the fiscal year ended December 31, 2025. This 10-K report offers essential insights into our progress, financial health, and future outlook. Climb Bio, Inc. trades on the Nasdaq Global Market under the ticker symbol CLYM.

Business Overview: Who is Climb Bio, Inc. and What's Our Mission?

Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for rare neurological disorders. Our primary focus is advancing CLYM-101, a novel gene therapy designed to address the genetic root cause of Spinal Muscular Atrophy (SMA). As an "Emerging Growth Company" and "Smaller Reporting Company," we benefit from certain reduced reporting requirements. This is common for companies heavily invested in research and development, reflecting both significant growth potential and the inherent risks of early-stage drug development.

Business Highlights and Strategic Progress (MD&A Highlights)

In fiscal year 2025, Climb Bio achieved significant milestones in its clinical development program:

• CLYM-101 Advanced to Phase 2: We successfully completed the Phase 1 clinical trial for CLYM-101 in Q2 2025. This trial demonstrated a favorable safety profile and showed preliminary signs of effectiveness in a small group of SMA patients. This success allowed us to initiate a multi-center Phase 2 trial in Q4 2025, where initial patient enrollment surpassed our internal targets.
• Preclinical Pipeline Expansion: We also expanded our preclinical pipeline. Two additional gene therapy candidates, CLYM-202 (for Huntington's Disease) and CLYM-303 (for Amyotrophic Lateral Sclerosis), showed promising results in animal studies (in vivo models). We expect to file an Investigational New Drug (IND) application for CLYM-202 in late 2026, a critical step before human clinical trials can begin.
• Strategic Partnerships: In Q3 2025, we partnered with a leading academic institution to explore new ways to deliver gene therapies, enhancing our technological capabilities.

Financial Performance at a Glance

Climb Bio's financial results for the fiscal year ended December 31, 2025, reflect our status as a clinical-stage company heavily investing in research and development:

• Revenue: We reported $1.2 million in grant revenue, primarily from government and non-profit organizations supporting rare disease research. This is an increase from $0.8 million in 2024.
• Net Loss: We reported a net loss of $38.5 million, or ($0.80) per share, up from a $29.1 million net loss in 2024. This larger loss mainly stems from increased clinical trial expenses for CLYM-101 and preclinical development costs.
• Research & Development (R&D) Expenses: R&D expenses totaled $32.7 million, an increase from $24.5 million last year. This highlights our commitment to advancing our pipeline.

Financial Health (Debt, Cash, Liquidity)

• Cash Position: As of December 31, 2025, we held $55.3 million in cash and cash equivalents. We successfully completed a follow-on public offering in Q1 2025, raising $45.0 million in net proceeds to fund ongoing clinical trials and research.
• Liquidity: Based on current projections, we estimate this cash can fund operations into Q3 2027.
• Debt: We reported no significant long-term debt as of December 31, 2025, relying primarily on equity financing to fund our operations.
• Market Capitalization: As of June 30, 2025, our public float (the total value of shares available to the public) was approximately $44.8 million. We had roughly 47.8 million shares of common stock outstanding as of February 27, 2026.

Key Risks for Investors

Investing in Climb Bio, like many early-stage biotechnology companies, carries significant risks:

• Clinical Trial Success: The success of CLYM-101 and our other pipeline candidates is highly uncertain. Clinical trials can fail at any stage due to lack of effectiveness, safety concerns, or unexpected side effects.
• Regulatory Approval: Even with successful trials, regulatory approval from agencies like the FDA is not guaranteed. The approval process is lengthy, complex, and costly.
• Funding Needs: We will need substantial additional funding to complete clinical development, seek regulatory approvals, and commercialize any approved products. Future financing rounds could dilute the ownership of existing shareholders.
• Competition: The rare neurological disorder space is competitive. Larger pharmaceutical companies and other biotechs are developing similar or alternative treatments.
• Intellectual Property: Our success depends on our ability to obtain and maintain patent protection for our technologies and products.

Competitive Position

The biopharmaceutical industry is highly competitive and rapidly evolving. Climb Bio faces significant competition from larger pharmaceutical and biotechnology companies, academic institutions, and other research organizations. Many of these competitors have greater financial, technical, and human resources. These competitors may develop products that are more effective, safer, more convenient, or less costly than ours.

Key competitive factors in the rare neurological disorder space are:

• The effectiveness and safety profile of product candidates.
• The timing and breadth of regulatory approvals.
• The availability of sufficient manufacturing and supply.
• Our ability to obtain and maintain patent protection and other intellectual property rights.
• Our ability to attract and retain qualified scientific and management personnel.
• Our ability to establish effective sales, marketing, and distribution channels.

We believe our competitive advantages stem from our novel gene therapy approach, our focus on addressing the genetic root causes of rare neurological disorders, and our intellectual property portfolio for CLYM-101 and our preclinical candidates. However, developing new treatments for these conditions is an active research area. New therapies or alternative treatment methods could emerge and impact our market opportunity.

Future Outlook (Guidance, Strategy)

Looking ahead to 2026, our strategic priorities include:

• Continue patient enrollment and data collection for the CLYM-101 Phase 2 trial, with an anticipated interim data readout in Q4 2026.
• Advance CLYM-202 toward an IND filing.
• Explore potential strategic partnerships for commercialization or further pipeline development.

We remain focused on our mission: to bring transformative therapies to patients suffering from rare neurological disorders, while carefully managing our financial resources to achieve key development milestones.