Nymox Pharmaceutical Corporation

Nymox Pharmaceutical Corporation (OTC: NYMX) is a biopharmaceutical company focused on the development and commercialization of fexapotide triflutate (NX-1207) — a novel therapeutic agent for benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate gland that causes lower urinary tract symptoms in a large proportion of older men worldwide. According to its website at nymox.com, the company's lead product candidate fexapotide is administered as a single in-office injection directly into the prostate gland under ultrasound guidance, designed to provide durable relief from BPH symptoms through a mechanism of selective tissue reduction in the enlarged prostate without the systemic side effects associated with oral medications or the risks and recovery requirements of surgical BPH treatments. Nymox believes fexapotide could provide a compelling office-based treatment option between medication and surgery for men with moderate to severe BPH symptoms.

Nymox's clinical development program for fexapotide, described at nymox.com, has encompassed multiple Phase 3 clinical trials evaluating the safety and efficacy of the 2.5 mg dose of fexapotide in men with symptomatic BPH, generating clinical data on urinary symptom improvement, peak urinary flow rate, prostate volume reduction, and long-term durability of treatment effect. The company has engaged with the FDA through multiple New Drug Application submissions and interactions aimed at securing regulatory approval for fexapotide as a novel BPH treatment option, navigating the regulatory review process and addressing agency questions about the clinical evidence package supporting the application. BPH affects tens of millions of men in the United States and hundreds of millions worldwide, representing a large and commercially significant patient population for effective new treatment options.

Nymox Pharmaceutical Corporation is publicly traded on the OTC markets and pursues its regulatory strategy for fexapotide alongside evaluation of strategic partnership opportunities with pharmaceutical companies that could provide the commercial infrastructure and financial resources to bring fexapotide to market if regulatory approval is achieved. According to nymox.com, the company's management team brings pharmaceutical development, regulatory affairs, and urology clinical expertise that supports both the ongoing regulatory engagement process and the strategic partnership discussions that could enable the commercialization of fexapotide in the large BPH treatment market. Nymox's combination of novel BPH treatment mechanism, office-based injection administration, Phase 3 clinical evidence, FDA engagement, and OTC-listed public company structure reflects its position as a development-stage pharmaceutical company pursuing approval of a potentially distinctive new option for BPH treatment.