Climb Bio, Inc. (CLYM)·Q1 2025 Earnings Summary

Executive Summary

• Climb Bio reported a larger Q1 net loss driven by upfront licensing and program ramp: net loss was $(20.8)M with diluted EPS of $(0.31), reflecting a $9.0M upfront payment for CLYM116 and higher budoprutug spend .
• EPS missed Wall Street consensus: actual $(0.31) vs $(0.15), while revenue remained in line at $0; increased R&D was the primary driver of the miss (see Estimates Context) .
• Balance sheet remains strong: cash, cash equivalents and marketable securities of $197.8M fund operations “through 2027,” consistent with prior guidance .
• Execution milestones maintained: first‑patient‑in for ITP and SLE in H1’25, pMN Phase 2 start in H2’25, subcutaneous (SC) healthy volunteer study H2’25, and CLYM116 IND/CTA submission in H2’25 .
• Potential stock catalysts near term: first‑patient‑in for ITP/SLE and any pMN site activations; medium term: SC budoprutug HV data and CLYM116 IND/CTA submission; longer term: clinical readout timing clarity later in 2025 per management .

What Went Well and What Went Wrong

What Went Well

• Regulatory momentum and pipeline expansion: FDA cleared Phase 2 in pMN and Phase 1b/2a in ITP in March; SLE IND previously cleared; CLYM116 in-licensed in January for IgAN with IND/CTA targeted in H2’25 .
• Strategic/commercial readiness: subcutaneous budoprutug formulation advancing with plan to start a healthy volunteer Phase 1 in H2’25, potentially enabling broader access and home dosing .
• Leadership and governance: appointed two independent directors (Kim C. Drapkin, CPA, and Bo Cumbo) and added a Chief Business Officer (Perrin Wilson, Ph.D.), bolstering financial, commercial, and BD capabilities .

Quoted management: “2025 is a critical year of execution… budoprutug… 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 are advancing the subcutaneous formulation…” — Aoife Brennan, President & CEO .

What Went Wrong

• EPS miss vs. consensus: $(0.31) actual vs $(0.15)* estimate, driven by a step‑up in R&D (notably the $9.0M CLYM116 upfront) and higher G&A from scale‑up, resulting in a larger loss than anticipated .
• Operating expenses spiked year over year and sequentially: R&D rose to $17.3M (from $1.1M in Q1’24; $6.0M in Q4’24), G&A to $5.7M (from $1.9M in Q1’24; $5.0M in Q4’24) as programs and headcount scaled .
• Internal controls: management reported material weaknesses in internal control over financial reporting, though financials were deemed fairly presented; remediation is underway (hiring, policies, systems) .

Financial Results

Notes:

• The increase in R&D includes a $9.0M upfront payment for the CLYM116 license (Mabworks) and budoprutug program spend .
• Interest/other income benefited from higher balances in marketable securities vs prior year .

KPIs (Program and R&D Mix – Q1 2025)

Segments: Climb Bio operates a single reportable segment focused on immune‑mediated diseases .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1’25 earnings call transcript was available in the filing set; themes synthesized from 8‑K/press materials and 10‑Q .

Management Commentary

• Strategic focus: “We continue to make excellent progress developing a differentiated pipeline targeting immune‑mediated diseases… budoprutug… remains on track to initiate clinical studies in ITP and SLE in the coming weeks and in pMN in the second half of 2025… advancing the subcutaneous formulation…” — Aoife Brennan, President & CEO .
• On CLYM116: “We have also made progress with our CLYM116 program… look forward to sharing detailed preclinical data… and anticipate submitting an IND or CTA by year end.” — Aoife Brennan .

Q&A Highlights

• No Q1 2025 earnings call transcript was available as of the Q1 filing; clarifications from filings include:
  • R&D expense bridge: $9.0M upfront for CLYM116 plus budoprutug program and personnel drove the increase .
  • ATM facility capacity: $22.35M established in March; no shares sold in Q1’25, providing optional financing flexibility .
  • Internal control remediation actions are underway (personnel, policies, systems) following identified material weaknesses .

Estimates Context

Values marked with * retrieved from S&P Global.

Implications:

• EPS missed in Q1’25 on higher‑than‑modeled R&D (CLYM116 upfront and budoprutug program costs) and higher G&A as the organization scales .
• Revenue in‑line at $0 given pre‑commercial stage and no product sales .

Key Takeaways for Investors

• Near‑term catalysts are execution‑driven: first‑patient‑in for ITP and SLE in H1’25, plus pMN Phase 2 site activations, which should frame the clinical cadence into 2026 .
• Mid‑term data flow: SC budoprutug healthy volunteer trial initiation (H2’25) and CLYM116 preclinical package with IND/CTA filing by year‑end can broaden the story beyond budoprutug IV .
• Balance sheet supports plan through 2027; optionality from a $22.35M ATM (unused in Q1) provides incremental flexibility in volatile markets .
• Expect OpEx to remain elevated as multiple trials start; the Q1 EPS miss reflects step‑function investment (license upfront, program ramp) rather than execution shortfall .
• Watch internal control remediation and continued hiring as organizational scaling continues; no misstatements were reported, but oversight remains a focus .
• Strategically, CD19 and APRIL positions CLYM across B‑cell mediated diseases with multiple shots on goal; initial readout timing clarity expected later in 2025 .

Appendix: Source Documents

• Q1 2025 8‑K (press release) and exhibits: financials, pipeline and cash runway .
• Q1 2025 10‑Q: detailed financial statements, R&D split, liquidity, internal controls .
• Q4 2024 8‑K (press release): prior quarter financials, pipeline milestones, cash .
• Q3 2024 8‑K (press release): prior year quarter financials and budoprutug pMN data .
• Jan 10, 2025 8‑K: CLYM116 license terms and preliminary year‑end cash update .