December Potential Milestones / Catalysts - K t

December Potential Milestones / Catalysts

- K top-line data (Phase 1)
- Orphan drug designation for K-pancreatic cancer
- Shareholders meeting (December 15, 2015)

Q1 2016 Potential Milestones / Catalysts

- P top-line data (Phase 2)
- Start of B-ABSSSI (Phase 3)
- Biotech Showcase (January 11-13, 2016)
- FDA meeting on K-ovarian cancer (Phase 2)
- Nasdaq uplist

Past Milestones

- QIDP designation for B-ABSSSI
- Fast track designation for B-OM
- Orphan drug designation for K-ovarian cancer
- Orphan drug designation for K-retinoblastoma
- B-ABSSSI positive Phase 2b top-line & bottom line data
- Completion of cohort 11 (750 mg/m2)
- P primary endpoint met (Phase 1)
- Stable formulation of B at room temperature
- MTA extension on testing B in implanted devices (pending FDA approval)

Clinical Trials

1. P (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1
2. P (Phase 2, not recruiting): https://clinicaltrials.gov/ct2/show/NCT021012...amp;rank=2
3. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
4. K (Phase 1, not recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4
5. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;rank=5

Abbreviations

K – Kevetrin
B – Brilacidin
P – Prurisol
OM – oral mucositis
ABSSSI – acute bacterial skin and skin structure infections
QIDP – qualified infectious disease product