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Successful Phase 3 Extension Trial of Nymox's Fexapotide (NX-1207) for BPH

The Phase 3 extension trial of Fexapotide (NX-1207) for Benign Prostatic Hyperplasia (BPH) meets primary endpoint, showing significant improvements in AUA BPH Symptom Score and patient responder rate. The treatment also reduces nocturia and lowers the risk of prostate cancer. Fexapotide is a safe and effective option for BPH with no sexual, cardiovascular, or hormonal side effects.

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Successful Phase 3 Extension Trial of Nymox's Fexapotide (NX-1207) for BPH

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  1. Nymox Pivotal Phase 3 Fexapotide (NX-1207) BPH Extension Trial Successfully Meets Primary Endpoint

  2. Primary Endpoint AUA BPH Symptom Score • Single injection results after median 42 months post-treatment (range 24 months to 65 months) • Mean improvement 5.3 points (p<.025 vs placebo) • First-line treatment with fexapotide mean improvement 7.16 points (p<.02 vs placebo)

  3. BPH Improvement

  4. AUA BPH Symptom Score Patient Responder Rate • Statistically significant higher proportion of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects (64%) vs controls (p<.005)

  5. Nocturia • Median 42 months post-single injection treatment • Stabilization or improvement 87% (p<.03 vs placebo)

  6. Surgery for BPH • 1.7% in 2 years after 1-2 injections of fexapotide (p<.02 vs placebo)

  7. Fexapotide Lowered Cancer Risk • Phase 2 US data showing reduced progression of low grade prostate cancer in fexapotide treated patients • This is in contrast to elevated cancer risk for some approved BPH oral medications

  8. Nymox Fexapotide Advantages • Safe drug with durable efficacy • Office-based 1-2 minute injection • Single painless injection: no sedation, no anesthesia • No sexual side effects (commonly seen with older approved BPH medications) • No cardiovascular or hormonal side effects (commonly seen with older approved BPH medications) • Decreased cancer risk (Phase 2 data) (vs increased risk seen with older approved BPH medications)

  9. Nymox Fexapotide Safety Profile Superior to BPH approved medications • No sexual or cardiovascular side effects • No hormonal side effects • No increased risk of prostate cancer (decreased risk with fexapotide, Phase 2)

  10. Nymox Fexapotide Efficacy Profile Highly durable effect: • Single painless office injection with long-term benefit • After a single injection with fexapotide, the majority of patients in Phase 3 pivotal studies required no further oral medications or surgery for up to 5.4 years (median 42 months). • First-line single treatment after 3.5 years: 7.16 point mean improvement

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