Early safety data is clean but from a small sample (n=49) — not yet de-risking the program. The key catalyst is Phase 2 initiation in IgAN patients by partner Mabworks in Q3 2026. Monitor for efficacy data and any safety signals as dosing expands.
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Executive Summary
Climb Bio announced translational pharmacometric modeling and initial Phase 1 safety data for CLYM116, its anti-APRIL monoclonal antibody. Preliminary data from 49 healthy volunteers showed no serious adverse events, dose-limiting toxicities, or discontinuations, with all adverse events mild-to-moderate and self-resolving. The company plans to advance CLYM116 into further development, and partner Mabworks expects to initiate Phase 2 dosing in IgAN patients in Q3 2026.
Key Facts
- CLYM116 is an anti-APRIL monoclonal antibody for IgA nephropathy and other immune-mediated diseases.
- Initial Phase 1 safety data from 49 healthy volunteers (single doses up to 320 mg or placebo) showed no SAEs, DLTs, or discontinuations.
- All adverse events were Grade 1-2, transient, and self-resolving; injection site reactions in two patients (Grade 1) resolved without intervention.
- Translational PK/PD model from NHP data projects dose-dependent IgA suppression and potential for less-frequent dosing vs. first-generation anti-APRIL approaches.
- Partner Mabworks expects to initiate Phase 2 dosing in IgAN patients in Q3 2026.
- Global Phase 1 strategy includes parallel healthy volunteer datasets ex-China and China (n=80, doses 25 mg to 640 mg).
Financial Impact
No financial figures disclosed; early-stage clinical data with no revenue or expense impact reported.
Risk Factors
- Small sample size (n=49) limits safety conclusions; larger Phase 2 may reveal new safety signals.
- Translational PK/PD model from NHP data may not predict human efficacy; IgA suppression correlation is literature-based, not from CLYM116 human data.
- Partner-dependent development in China adds execution risk; timelines may slip.
- No financial data or guidance provided; pre-revenue biotech with no near-term revenue catalyst.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-258372 |
| Document: 0001193125-26-258372-index-headers.html | 0001193125-26-258372 |
| Document: 0001193125-26-258372-index.html | 0001193125-26-258372 |
| Document: 0001193125-26-258372.txt | 0001193125-26-258372 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | — | awaiting T+1 | — | — |
Oct 23, 2026 3d ago | 8-K | $10.47 | awaiting T+1 | — | $8.81 (−15.85%) |
Oct 23, 2026 3d ago | Press Release | $10.34 | awaiting T+1 | — | $8.81 (−14.80%) |
Sep 22, 2026 4w ago | Institutional Cluster | $14.21 $12.52 | ▼ −11.89% | ▼ −11.17% | $8.81 (−38.00%) |
Sep 3, 2026 7w ago | 8-K | $14.59 $15.52 | ▲ +6.37% | ▲ +6.76% | $8.81 (−39.62%) |
Aug 14, 2026 10w ago | 8-K | $16.33 $17.44 | ▲ +6.80% | ▲ +7.27% | $8.81 (−46.05%) |
Aug 6, 2026 11w ago | 8-K | $14.00 $14.00 | · 0.00% | ▼ −0.61% | $8.81 (−37.07%) |
Jun 30, 2026 16w ago | 144 | $13.29 $12.90 | ▼ −2.93% | ▼ −2.80% | $8.81 (−33.71%) |
Jun 12, 2026 19w ago | 8-K | $11.49 $10.71 | ▲ +6.79% | ▲ +6.19% | $8.81 (+23.32%) |
Jun 12, 2026 19w ago | 424B5 | $11.49 $10.71 | ▲ +6.79% | ▲ +6.19% | $8.81 (+23.32%) |
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