Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Inclusion Criteria:

- Be male aged 45 or older.

- Sign an informed consent form.

- Be in good health.

- Received NX-1207 in a previous completed study or received NX-1207 or placebo in a
concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day)
visit.

- Have Prostate Gland Volume ≥ 25 mL (25 g).

Exclusion Criteria:

- Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after
first NX-1207 injection

- Post-void residual urine volume > 200 mL

- Presence of a symptomatic median lobe of the prostate

- History of use of self-catheterization for urinary retention.

- Urinary retention in the previous 12 months.

- Prostatitis

- Urinary tract infection more than once in the past 12 months

- Prostate or bladder cancer.

- PSA ≥10 ng/mL

- Poorly controlled diabetes

- History or evidence of illness or condition that may interfere with study or endanger
subject

- Participation in a study of any investigational drug (other than NX-1207) or
investigational device within the previous 90 days

- Use of specific prescribed medications that may interfere with study or endanger
subject