Eliem Therapeutics, Inc. (ELYM)·Q3 2024 Earnings Summary

Executive Summary

• Rebranded to Climb Bio and delivered a strategic execution quarter: FDA cleared the IND to start a Phase 1b SLE trial in 1H25; ITP Phase 2 and late‑phase pMN are also planned for 2025, and a high‑concentration subcutaneous (SC) formulation advanced toward 1H25 non‑clinical readout .
• Cash, cash equivalents and marketable securities were $217.9M at 9/30/24, with runway “through 2027,” supporting multiple clinical catalysts in 2025 .
• Q3 2024 reflected the R&D scale‑up: R&D (incl. related party) rose to $6.2M and G&A to $5.5M; net loss was $8.9M (vs. $4.0M in Q3’23) as the company transitions to an immunology pipeline centered on CD19 mAb budoprutug .
• Additional positive clinical signals: in completed pMN Phase 1b, 3/5 (60%) achieved complete remission; deep/sustained B‑cell depletion was observed; SLE IND cleared; management and board further strengthened .

What Went Well and What Went Wrong

• What Went Well
  • Regulatory progress: FDA cleared the IND for a Phase 1b SLE trial; ITP Phase 2 also targeted for 1H25, with pMN moving to late‑phase in 2025 .
  • Clinical data momentum in pMN: 3/5 (60%) complete remission, rapid anti‑PLA2R declines, sustained B‑cell depletion; favorable tolerability with no drug‑related SAEs in the cohort receiving 4 doses .
  • Capital and leadership: $217.9M cash/securities and runway through 2027; new Board Chair Doug Williams and VP CMC Gary Hao added to accelerate development .
  • Management tone: “well‑positioned to develop improved treatments…,” highlighting IND clearance and team build‑out (Aoife Brennan) .
• What Went Wrong
  • Operating spend and losses widened as programs ramped: Q3 R&D (incl. related party) $6.2M vs. $2.9M YoY; G&A $5.5M vs. $2.1M YoY; net loss $8.9M vs. $4.0M YoY .
  • Ongoing internal control material weaknesses remained as of Q3 2024, though remediation is underway .
  • Business still pre‑revenue and dependent on successful development of budoprutug; multiple risk disclosures emphasize funding needs and development uncertainty .

Financial Results

Income statement comparison (oldest → newest):

Liquidity (oldest → newest):

Notes:

• Q2 net loss primarily reflects $51.7M acquired IPR&D from the Tenet/TNT119 (budoprutug) transaction .
• Company remains pre‑revenue; no segment reporting (single operating segment) .

Guidance Changes

Earnings Call Themes & Trends

(No Q3 earnings call transcript was available; themes reflect 10‑Q, Q3 PR, and Q3 investor event)

Management Commentary

• “We have now received U.S. Food and Drug Administration clearance of our IND for our Phase 1b clinical trial of budoprutug in SLE … With a strong financial position and continued progress towards building our management team, we believe we are well‑positioned to develop improved treatments…” — Aoife Brennan, President & CEO (Q3 release) .
• “We believe CD19 is the optimal target for B‑cell mediated diseases and that an antibody is the modality with the broadest potential to help patients.” — Aoife Brennan (Investor Event PR) .
• “The patients in the pMN trial demonstrated high rates of complete clinical remission… rapid reductions in B‑cells and anti‑PLA2R antibodies…” — Dr. Frank Cortazar, pMN PI (Investor Event PR) .

Q&A Highlights

• No earnings call transcript for Q3 2024 was available. Key clarifications from filings and press materials:
  • Trial timing: SLE Phase 1b and ITP Phase 2 targeted for 1H25; pMN moving into late‑phase during 2025 .
  • SC formulation: high‑concentration, low‑viscosity budoprutug formulation supports potential for convenient SC dosing; non‑clinical data expected 1H25 .
  • Capital runway: cash/securities $217.9M at Q3 with runway through 2027 .

Estimates Context

• Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable for this issuer/period; therefore, we cannot benchmark reported results versus consensus at this time. Results should be evaluated versus prior quarter and prior year, and against 2025 clinical milestone timing disclosed in company materials .

Key Takeaways for Investors

• 2025 is catalyst‑rich: SLE Phase 1b and ITP Phase 2 initiations in 1H25; pMN late‑phase program initiation in 2025; SC formulation non‑clinical update in 1H25 .
• Cash runway through 2027 provides multi‑year funding to reach value inflection points without near‑term financing risk .
• pMN Phase 1b signals (60% CR; robust B‑cell depletion) de‑risk mechanism and support expansion across B‑cell‑mediated diseases .
• Operating expenses are scaling with pipeline execution; expect continued R&D and G&A growth as trials launch; monitor spend discipline and program pacing .
• Governance and execution capacity improved with experienced Board Chair and CMC leadership appointments .
• Risk remains high typical of early clinical biotech: pre‑revenue status, internal control remediation underway, and dependence on budoprutug success across multiple indications .

Appendix: Additional Relevant Q3 Press Materials

• Investor event (Oct 15, 2024): preliminary Q3 cash (~$218M), strategy, and additional pMN/MCD data; reiterated 2025 clinical plans and SC formulation progress .
• Corporate actions: name/ticker change to Climb Bio (CLYM) effective Oct 3, 2024 .