TNXP Tonix Pharmaceuticals Holding Corp.
Price Chart
Executive Summary
Tonix Pharmaceuticals presented Phase 1 data for TNX-4800, a long-acting monoclonal antibody to prevent Lyme disease, at the Global Lyme Alliance. The Phase 1 study (N=44) showed TNX-4800 was safe and well-tolerated with a mean half-life of 62-69 days and dose-proportional PK. Pharmacokinetic simulations support a two-dose 350mg SC regimen maintaining serum levels above the 10 µg/mL MEC for 196 days, supporting the planned adaptive Phase 2 field study in 1H 2027. The company also reported ~$185.5M cash as of March 31, 2026, with no debt.
Actionable Insight
Positive Phase 1 safety/PK data and clear path to Phase 2 field study in 1H 2027 de-risk TNX-4800. With ~$185.5M cash and no debt, Tonix is well-funded through this catalyst. Monitor for FDA feedback on Phase 2 design (Type C meeting scheduled) and GMP manufacturing progress in 3Q 2026.
Key Facts
- Phase 1 trial (N=44) showed TNX-4800 safe and well-tolerated with no treatment-related SAEs and predominately mild AEs
- Mean half-life of TNX-4800 ranged from 62-69 days across dose groups
- PK simulations predict a two-dose 350mg SC regimen maintains serum levels above 10 µg/mL MEC for 196 days, supporting 6-month protection
- Planned adaptive Phase 2 field study in 1H 2027, pending FDA agreement
- Company had ~$185.5M cash as of March 31, 2026, with no debt
- TNX-4800 is a human anti-OspA monoclonal antibody with engineered Fc domain for extended half-life, licensed from UMass Chan Medical School in 2025
Financial Impact
No revenue or earnings impact; ~$185.5M cash position supports development through Phase 2
Risk Factors
- Phase 2 field study requires FDA agreement and faces enrollment/execution risk in Lyme-endemic areas
- TNX-4800 is still investigational; no guarantee of regulatory approval or commercial success
- Competition from OspA vaccines and other prophylactic mAbs in development
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001999371-26-010790 |
| Document: tnxp-8k_051526.htm | 0001999371-26-010790 |
| Document: 0001999371-26-010790-index-headers.html | 0001999371-26-010790 |
| Document: 0001999371-26-010790-index.html | 0001999371-26-010790 |
| Document: 0001999371-26-010790.txt | 0001999371-26-010790 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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May 15, 2026
5d ago
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8-K
| $14.13 awaiting T+5 | awaiting T+5 | — | $14.50 (+2.62%) |
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May 14, 2026
6d ago
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Press Release
| — | awaiting T+5 | — | — |
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May 11, 2026
9d ago
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8-K
| $13.28 $14.26 | ▼ −7.38% | ▼ −7.30% | $14.50 (−9.19%) |
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Apr 29, 2026
21d ago
|
8-K
| $12.40 $13.50 | ▲ +8.87% | ▲ +5.76% | $14.50 (+16.94%) |
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Apr 23, 2026
27d ago
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8-K
| $12.49 $12.40 | ▼ −0.72% | ▼ −2.20% | $14.50 (+16.09%) |
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Apr 15, 2026
5w ago
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Press Release
| $14.34 $13.11 | ▼ −8.58% | ▼ −10.22% | $14.50 (+1.12%) |
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Mar 26, 2026
7w ago
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Press Release
| $13.75 $13.90 | ▲ +1.09% | ▼ −0.54% | $14.50 (+5.45%) |
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Mar 23, 2026
8w ago
|
Press Release
| $15.34 $13.75 | ▼ −10.37% | ▼ −9.94% | $14.50 (−5.48%) |
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Mar 17, 2026
9w ago
|
Press Release
| $14.19 $15.00 | ▲ +5.71% | ▲ +6.42% | $14.50 (+2.18%) |
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Mar 13, 2026
9w ago
|
8-K
| $13.24 $15.00 | ▲ +13.29% | ▲ +15.41% | $14.50 (+9.52%) |
US Market Status
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