Name: Climb Bio, Inc. Q3 2024 Earnings Call
Start: 2024-11-12T00:00:00.000Z

Executive Summary

Q3 2024 was execution-heavy: no product revenue and a net loss of $8.9M, but losses narrowed sharply versus Q2 2024 given the absence of the one-time acquired IPR&D expense booked in Q2, and operating momentum advanced across SLE/ITP/pMN and SC formulation programs .
Cash, cash equivalents and marketable securities stood at $217.9M, with management reiterating cash runway expected through 2027, anchoring medium-term development plans across indications .
Key regulatory/milestone progress: FDA IND clearance for budoprutug in systemic lupus erythematosus (SLE); continued pMN clinical momentum; ITP Phase 2 planning; subcutaneous formulation progress—positioning multiple potential catalysts in 2025-2026 .
Consensus EPS/Revenue estimates from S&P Global were unavailable at time of writing; no beat/miss assessment can be made; focus shifts to operational and pipeline milestones as stock reaction catalysts [GetEstimates error].

What Went Well and What Went Wrong

FDA cleared the IND for budoprutug in SLE, enabling a Phase 1b study in 1H 2025; management emphasized readiness and the breadth of the opportunity in immune-mediated diseases .
pMN Phase 1b data reinforced clinical potential: complete remission of proteinuria in 3/5 (60%) patients, rapid anti‑PLA2R reductions, and complete sustained B‑cell depletion across all dosed patients; budoprutug generally well-tolerated .
Strengthened leadership and CMC capabilities: Douglas E. Williams, Ph.D., appointed Chair; Gary Hao, Ph.D., appointed VP CMC—experience spans multiple successful drug programs and CMC scale-up .

Operating expenses rose y/y: R&D to $6.2M (+117% including related party), G&A to $5.5M (+158%), as Climb pivoted to immune-mediated diseases, incurred restructuring costs and increased legal/consulting fees .
Material weaknesses in internal control over financial reporting identified (personnel depth, formal policies/segregation of duties), with remediation underway but not yet complete .
Continued absence of product revenue and ongoing losses: net loss of $8.9M in Q3; company reiterates it may never achieve profitability without successful development/commercialization, underscoring financing and execution risks .

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD Millions)	$0 (no product revenue)	$0 (no product revenue)	$0 (no product revenue)
Net Loss per Share (EPS, $)	$(0.15)	$(1.81)	$(0.13)
R&D Expense ($USD Millions)	$2.88	$1.05	$6.24
G&A Expense ($USD Millions)	$2.13	$3.67	$5.49
Other Income, net ($USD Millions)	$1.03	$1.48	$2.84
Net Loss ($USD Millions)	$(3.97)	$(54.89)	$(8.90)

Notes:

Q2 2024 included a one-time acquired IPR&D expense of $51.66M related to the Tenet acquisition, driving the outsized quarterly loss .
Company operates as a single reportable segment; margin metrics (EBIT/Net margins) are not meaningful given no revenue .

KPIs

KPI	FY 2023 YE	Q3 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$106.8	$217.9
Total Assets ($USD Millions)	$110.5	$222.2
Stockholders’ Equity ($USD Millions)	$107.6	$218.8

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Through 2027	Through 2027 (Q3 2024 PR)	Through 2027 (Q1/Q2 2025 PRs)	Maintained
Budoprutug – SLE Phase 1b	1H 2025 start	Planned post-IND clearance	Initiation in 1H 2025 on track	Maintained
Budoprutug – ITP Phase 2	1H 2025 start	Planned	Enrollment ongoing (Phase 1b/2a)	Raised (execution progress)
Budoprutug – pMN late phase	2025	Plan to engage regulators/advance in 2025	Phase 2 to initiate in coming weeks	Raised (timing specificity)
Budoprutug – SC formulation	Non‑clinical 1H 2025; Phase 1 start H2 2025	High‑concentration SC formulation advancement	CTA cleared; Phase 1 start in coming weeks; initial data H1 2026	Raised (program advanced)

Topic	Previous Mentions (Q1 2025, Q2 2025)	Current Period (Q3 2024)	Trend
Regulatory milestones (SLE, ITP, pMN)	INDs cleared for ITP; FDA clearance for pMN Phase 2; SLE ex‑US sites pursued	IND cleared for SLE; plan to initiate SLE Phase 1b 1H 2025; ITP Phase 2 planning	Strengthening, multiple trials poised
R&D execution (pMN data, SC formulation)	Dosing started in ITP/SLE; pMN Phase 2 imminent; SC Phase 1 HVs to begin	pMN Phase 1b data with 60% CR; SC formulation above 175 mg/mL, low viscosity	Positive clinical signal; formulation de‑risking
Pipeline expansion (CLYM116, IgAN)	License with Mabworks; IND/CTA H2 2025; investor event planned Sept 2025	Focus on budoprutug core; broader immune-mediated scope articulated	Broadening beyond anti‑CD19
Capital and runway	$197.8M–$187.4M cash at Q1–Q2 2025; runway through 2027	$217.9M at Q3 2024; runway through 2027	Stable/extended post financing
Organization/leadership	Added independent directors, CBO, CMO	New Chair (Williams), VP CMC (Hao)	Bolstering governance/CMC scale-up

“We have had a very productive third quarter… With a strong financial position and continued progress towards building our management team, we believe we are well‑positioned to develop improved treatments for… immune‑mediated diseases.” — Aoife Brennan, President & CEO .
“We have executed with focus and discipline, building the team and advancing our pipeline… dosed patients in both the ITP and SLE clinical trials… regulatory clearance to initiate the pMN Phase 2 trial and the Phase 1 trial of subcutaneous budoprutug…” — Aoife Brennan .
“2025 is a critical year of execution… budoprutug… on track to initiate clinical studies in ITP and SLE… and in pMN in the second half of 2025… advancing the subcutaneous formulation…” — Aoife Brennan .

No Q3 2024 earnings call transcript was available in the document catalog; Q&A highlights not published/accessible [ListDocuments earnings-call-transcript=0].

Wall Street consensus EPS and revenue estimates (S&P Global) for Q3 2024 were unavailable due to access limitations at time of request; therefore, no beat/miss assessment vs consensus can be provided [GetEstimates error].

Net loss narrowed significantly q/q versus Q2 2024 on the absence of the one‑time acquired IPR&D expense, while R&D and G&A stepped up to support pipeline progress; expect operating spend to trend with trial initiations .
Cash runway through 2027 provides multi‑indication optionality to reach value inflection points in SLE, ITP, and pMN, plus SC formulation and APRIL/IgAN program development .
pMN efficacy signal (60% complete proteinuria remission, robust B‑cell/anti‑PLA2R dynamics) and tolerability support late‑phase advancement—watch Phase 2 start and design details for regulatory engagement read‑through .
Multiple near‑term catalysts: SLE and ITP dosing updates/readout timing guidance (H2 2025); pMN Phase 2 initiation; SC formulation Phase 1 start and H1 2026 data; CLYM116 investor event and IND/CTA submission in H2 2025 .
Operational risks remain: material control weaknesses under remediation; no revenue; reliance on future financings and execution across several trials—position sizing should reflect biotech development volatility .
Strategic hires (Chair, CMO, VP CMC) bolster clinical, governance, and manufacturing readiness—important as programs scale toward later‑stage studies .