Nymox Pharmaceutical Corporation is a biopharmaceutical company focused on developing its drug candidate, NX-1207, for the treatment of benign prostatic hyperplasia (BPH) and low-grade localized prostate cancer, with an extensive patent portfolio covering its investigational drug and other therapeutic and diagnostic indications. The company has incurred substantial operating losses since its inception in May 1995, with no revenues from product sales in the past three years, and faces significant competition from established pharmaceutical products and medical devices in the BPH market.

The company's treatments under development for BPH face significant competition from existing products, including alpha-blockers such as tamsulosin (Flomax®), alfusozin (Uroxatral®), and silodosin (Rapaflo®), and 5-alpha reductase inhibitors such as finasteride (Proscar®) and dutasteride (Avodart®), as well as combination drugs like Jalyn™. These drugs have been on the market for 20-30 years with expired initial patents. Additional competition comes from thermal treatments using microwave energy (Prostatron®, Targis Therapy®, TherMatrx®), low-level radiowaves (TUNA System®), lasers (Indigo LaserOptic Treatment System®, Laserscope GreenLight PVP™), surgical procedures like TURP, prostatic stents, and the FDA-approved Urolift™ system. The company also faces competition from major pharmaceutical, diagnostic, chemical, and biotechnology companies with significantly greater financial, technical, and marketing resources, as well as academic institutions and research organizations.

Nymox generates no revenue from product sales and relies primarily on the issuance of common stock to fund its operations, having raised over $204 million through the issuance of common stock or securities exercisable for shares of common stock since its incorporation. The company's primary sources of financing since 2003 have been the Common Stock Private Purchase Agreement and direct private placements of its common stock to qualified investors, with the objective of managing capital to ensure sufficient liquidity to finance research and development activities, general and administrative expenses, working capital, and capital expenditures.

The company's lead product candidate, NX-1207, is being developed for the treatment of BPH and low-grade localized prostate cancer. For BPH, NX-1207 successfully completed a multi-center, double-blind, placebo-controlled Phase 2 trial in September 2006, but the Phase 3 NX02-0017 and NX02-0018 U.S. clinical trials failed to meet their primary endpoints at 12 months post-treatment. However, the long-term extension studies successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo, with an excellent safety profile. The company has filed Marketing Authorization Applications in Denmark and the UK, with the UK application still under review. For prostate cancer, a Phase 2 U.S. clinical trial enrolled 147 patients at 28 clinical centers, with initial positive results reported in 2014. Preclinical studies of NX-1207 for hepatocellular carcinoma showed positive results, with cancers significantly reduced in size after 2 local injections.

Research and development expenditures were $1,481,965 for the year ended December 31, 2025, compared with $3,280,532 for 2024, and $3,994,809 for 2023. Total research and development expenditures to date, excluding stock-based compensation, depreciation, and amortization, are $105,229,000. The company has issued patents in major European markets, Japan, Canada, China, and Australia, with the earliest expiry date for U.S. patents covering NX-1207 in 2022, and potential patent term extension of up to five years or more if approved by the FDA.

In March 2022, the company submitted a new drug application with the FDA and received a Refusal to File Letter on May 20, 2022. In December 2022, the company filed a Marketing Authorization Application with Danish authorities, validated and accepted for review on February 13, 2023, but the application ran out of time and requires re-submission with a new fee. On September 25, 2023, the company filed a Marketing Authorization Application with U.K. authorities, validated and accepted for review on October 26, 2023, and currently under review. The company has been involved in multiple legal proceedings, including a Bahamas derivative action that was terminated with the company awarded USD $203,075, and various California and Texas actions, with the company considering these actions without merit.

For the year ended December 31, 2025, the company reported a net loss of $4,275,475, or $0.05 per share, compared to a net loss of $4,491,797, or $0.05 per share, in 2024, and a net loss of $8,844,758, or $0.10 per share, in 2023. Total assets were $575,942 as of December 31, 2025, compared to $653,752 in 2024. The company had an accumulated deficit of $216.7 million as of December 31, 2025, and negative working capital of $9,306,391, with cash and cash equivalents of $6,000. Cash flows used in operations were $1,806,000 for 2025, and the company has never paid dividends.

Management expects that research and development expenditures will decrease more as a result of the Corporation's U.S. BPH trial activity reduction, pending the evaluation of the data. The company expects that revenues will significantly increase if and when product candidates pass clinical trials and are launched on the market, and that marketing expenditures will increase if and when new products are launched.

A key growth vector is the advancement of NX-1207 for BPH through regulatory approval, with Marketing Authorization Applications filed in Denmark and the UK. The UK MAA is currently under review, and the company intends to meet with regulatory authorities in other jurisdictions around the world and proceed to file for approval where possible. The company also plans to advance NX-1207 into human clinical trials for the treatment of hepatocellular carcinoma, based on positive preclinical results. For prostate cancer, the company is working towards definitive studies and data review for the indication, and potential regulatory review filings in jurisdictions around the world.

Another growth vector is the potential for collaboration and strategic partnering. The company anticipates entering into co-development and co-marketing agreements with one or more partners with established sales, marketing, and regulatory capabilities to assist in the completion of the development and commercialization of NX-1207. The company also anticipates having to partner with larger pharmaceutical companies to bring therapeutic products to market, given the very high costs of development of therapeutic products.

The company expects that general and administrative expenditures will increase if and when product development leads to expanded operations. The company expects that research and development expenditures will decrease more as a result of the Corporation's U.S. BPH trial activity reduction, pending the evaluation of the data. The company does not believe that inflation has had a significant impact on its results of operations.

The company anticipates outsourcing at least some of the manufacturing required for its products in order to control start-up and operating costs and to take advantage of existing manufacturing capabilities and capacity in the large contract manufacturing sectors. The company's facilities include leased office space in St. Laurent, Quebec, Canada of approximately 3,070 square feet, primarily used to store records, and a California office lease that has ended, with plans to move to a new location.

The company's capital allocation strategy focuses on financing research and development activities, general and administrative expenses, working capital, and overall capital expenditures, including those associated with patents. The company has never paid any dividends and does not expect to do so in the near future, expecting to retain any earnings or positive cash flow to finance and develop the business. The company relies heavily on financing to fund its operations, primarily through the Common Stock Private Purchase Agreement and direct private placements.

The company faces significant headwinds, including the need for additional financing to continue as a going concern. Management believes that current cash balances as at December 31, 2025 and anticipated funds from product sales will not be sufficient to fund its planned business operations and research and development programs over the next 12 months. There is a material uncertainty that casts substantial doubt about the Corporation's ability to continue as a going concern. The company also faces the risk of delays or failures in clinical trials, regulatory approval uncertainties, and the potential for stock price declines from setbacks.

The company faces regulatory and legal constraints, including the ongoing dispute with the Canadian Revenue Authorities regarding additional taxes for the domicile move from Canada to the Bahamas. The company is also involved in multiple legal proceedings, including actions filed by Mr. Lanham and Mr. Riley, with motions to dismiss pending. The company faces potential losses due to foreign currency exchange risks, primarily between the U.S. dollar and Canadian dollar, and does not currently engage in hedging activities.

Management's message emphasizes the company's focus on developing NX-1207 for BPH and prostate cancer, with a priority on moving therapeutic product candidates through clinical trials and regulatory review and approval. Management acknowledges the company has never made a profit and expects operating losses to continue for at least the next few years due to research and development expenditures. Key strategic priorities include advancing regulatory submissions, particularly the UK MAA currently under review, seeking collaboration partners for commercialization, and securing additional financing to support operations. Management believes that current cash balances and anticipated funds from product sales will not be sufficient to fund planned operations over the next 12 months, and intends to seek additional equity or financing through existing private placements and/or other sources of capital.

For the year ended December 31, 2025, the company reported total revenues of $0 ⁹, compared to $0 ¹⁰ in 2024 and $0 ¹¹ in 2023. Net loss was $4,275,475 ¹² for 2025, compared to $4,491,797 ¹³ in 2024 and $8,844,758 ¹⁴ in 2023. Basic and diluted loss per share was $0.05 ¹⁵ for 2025, $0.05 ¹⁶ for 2024, and $0.10 ¹⁷ for 2023. Loss from operating activities was $3,676,757 ¹⁸ in 2025, compared to $4,283,129 ¹⁹ in 2024 and $8,351,234 ²⁰ in 2023. The company had cash and cash equivalents of $6,000 ²¹ as of December 31, 2025, compared to $74,000 ²² in 2024. Net cash used in operating activities was $1,806,000 ²³ for 2025, compared to $2,601,000 ²⁴ in 2024 and $4,057,000 ²⁵ in 2023. The company had negative working capital of $9,306,391 ²⁶ as of December 31, 2025, and an accumulated deficit of $216.7 million ²⁷. Total assets were $575,942 ²⁸ as of December 31, 2025, compared to $653,752 ²⁹ in 2024. Stock-based compensation was $1,708,000 ³⁰ in 2025 and $671,151 ³¹ in 2024. Research and development expenditures were $1,481,965 ³² in 2025, compared to $3,280,532 ³³ in 2024. General and administrative expenses were $2,194,792 ³⁴ in 2025, compared to $1,002,596 ³⁵ in 2024. Finance costs were $587,440 ³⁶ in 2025, compared to $226,000 ³⁷ in 2024. The company had 102,040,140 ³⁸ shares outstanding as of December 31, 2025, and weighted average common shares of 96,040,140 ³⁹ for 2025, compared to 93,671,288 ⁴⁰ in 2024.

The company faces a material uncertainty regarding its ability to continue as a going concern, with cash and cash equivalents of only $6,000 ¹ and negative working capital of $9,306,391 ² as of December 31, 2025, and management believes current cash balances will not be sufficient to fund operations over the next 12 months. The company has never made a profit and has an accumulated deficit of $216.7 million ³. Regulatory approval for NX-1207 is highly uncertain, as the Phase 3 trials failed to meet primary endpoints at 12 months, and the FDA issued a Refusal to File Letter on May 20, 2022, while the Danish MAA ran out of time and requires re-submission. The company's stock fell approximately 82% ⁴ on November 3, 2014, from $5.14 ⁵ to $0.93 ⁶, following the announcement of failed Phase 3 endpoints, demonstrating the potential for significant stock price declines from regulatory setbacks. The company relies heavily on financing, with 105,040,140 ⁷ common shares issued and outstanding as of September 9, 2026, and 14,375,000 ⁸ share options outstanding, which could dilute existing shareholders. The company is involved in multiple legal proceedings, including a CRA dispute over additional taxes and various shareholder actions, which could result in material costs.