20-F: Nymox Pharmaceutical Corporation Reports Losses in 2023 Amid Ongoing Development Efforts

Sentiment:

Annual Results 29 August 2024 5:26 PM

📋All filings for Nymox Pharmaceutical CORP

Nymox Pharmaceutical Corporation's 2023 20-F filing reveals continued operating losses and a focus on advancing its drug candidate NX-1207 through regulatory approval processes.

Delay expectedRegulatory approval of NX-1207 for BPH has been delayed due to the required long-term follow up, data collection, and analysis.

Capital raiseThe Corporation will require additional funds to pursue its operations as a going concern for the fiscal year ending December 31, 2023 and beyond.The Corporations primary sources of financing since 2003 has been the Common Stock Private Purchase Agreement.If necessary, the Corporation intends to seek additional equity or finance through the existing private placements and/or other sources of capital in order to fund these operations and activities over the next year.

Worse than expectedThe company's net loss increased from 2022 to 2023.The company's cash position decreased significantly from 2022 to 2023.The company's total equity position worsened from 2022 to 2023.

Summary

Nymox Pharmaceutical Corporation's 20-F filing details the company's financial performance and operational activities for the year ended December 31, 2023.
The company incurred a net loss of $8.84 million, or $0.10 per share, compared to a net loss of $6.58 million, or $0.07 per share, in 2022.
Revenues from sales of goods were nil for both 2023 and 2022.
Research and development expenditures totaled $3.99 million in 2023, compared to $3.77 million in 2022.
As of December 31, 2023, Nymox had available cash of approximately $70,000 and a negative working capital of $3.18 million.
The company is pursuing regulatory approvals for its lead drug candidate, NX-1207, with applications under review in Denmark and the UK.
Nymox acknowledges a material uncertainty regarding its ability to continue as a going concern and may seek additional financing.
The company is involved in legal proceedings, including disputes with the Canadian Revenue Authorities and actions against former associates.
The company's common shares are currently traded on the OTC Pink Sheets after being delisted from the NASDAQ in July 2023.

Sentiment

Score: 3

Explanation: The document presents a negative outlook due to continued losses, limited cash, and uncertainty about the company's ability to continue as a going concern. While there are ongoing efforts to gain regulatory approval for NX-1207, the overall financial situation and legal challenges weigh heavily on the sentiment.

Positives

Nymox is actively pursuing regulatory approvals for NX-1207 in Europe.
The company has an extensive patent portfolio covering its marketed products, its investigational drug as well as other therapeutic and diagnostic indications.
The company is working towards definitive studies and data review for NX-1207 as a focal treatment for certain types of cancer.
The company has a long-term shareholder and board member, James G. Robinson, who has invested significantly in the company.

Negatives

Nymox has incurred substantial operating losses and has never made a profit.
The company has a negative working capital and limited cash reserves.
There is a material uncertainty regarding the company's ability to continue as a going concern.
The company's stock has been delisted from NASDAQ and is now traded on the OTC Pink Sheets.
The company is involved in ongoing legal disputes.
The company has material weaknesses in its internal control over financial reporting.

Risks

Nymox may not receive the required regulatory approvals to commercialize its products.
Clinical trials for therapeutic products may be delayed.
A setback in obtaining regulatory clearance could cause a drop in the share price.
The company may not be able to make adequate arrangements with third parties for commercialization.
The company may not achieve projected development goals in announced time frames.
Even if regulatory approvals are obtained, the company will be subject to stringent ongoing government regulation.
It is uncertain when, if ever, the company will make a profit.
The company faces challenges in developing, manufacturing, and improving its products.
The company faces significant and growing competition.
The company may not be able to successfully market its products.
Protecting patents and proprietary information is costly and difficult.
The company faces changing market conditions.
Health care plans may not cover or adequately pay for the company's products and services.
The company is subject to continuing potential product liability risks.
The issuance of new shares may dilute Nymox's stock.
The company faces potential losses due to foreign currency exchange risks.
The company has never paid a dividend and is unlikely to do so in the near future.
Cybersecurity breaches and other disruptions could compromise the company's information.

Future Outlook

The Corporation expects that research and development expenditures will decrease more as a result of the Corporations U.S. BPH trial activity reduction, pending the evaluation of the data, and that general and administrative expenditures will increase if and when product development leads to expanded operations.

Management Comments

Management believes that current cash balances as at December 31, 2023 and anticipated funds from product sales are not sufficient to fund substantially all its planned business operations and research and development programs over next 12 months.
Management believes that such operating losses will continue for at least the next few years as a result of expenditures relating to research and development of our potential therapeutic products.

Industry Context

The biopharmaceutical industry is intensely competitive, with Nymox facing competition from major pharmaceutical companies, biotechnology firms, and research organizations. The market for BPH treatments is well-established, with numerous existing drugs, thermal treatments, and surgical procedures.

Comparison to Industry Standards

Nymox's financial performance lags behind industry standards for profitable pharmaceutical companies, as it has consistently reported net losses.
Compared to companies with approved BPH treatments like Eli Lilly (Cialis/tadalafil) and AbbVie (Avodart/dutasteride), Nymox lacks a revenue-generating product.
The company's reliance on private placements for funding is not uncommon for development-stage biopharmaceutical companies, but it highlights the need for successful product commercialization.
The company's research and development expenditures are relatively low compared to larger pharmaceutical companies, reflecting its limited resources.

Legal Proceedings

The Canadian Revenue Authorities (CRA) is asserting that the Company owes additional taxes for the domicile move from Canada to the Bahamas, which the Company is contesting.
An application for Injunctive Relief and a Derivative Action was filed against the Company on or about October 3, 2023 in the Supreme Court of The Bahamas (Claim No. 2023/COM/com/0057).
Nymox filed an action in the Superior Court of California, County of Orange (Case No. 30-2023-01358191-CU-BC-WJC) against Defendants Randall Lanham, M. Richard Cutler, Chris Riley, and Committee to Restore Nymox Share Value, seeking damages and injunctive relief arising from Defendants breaches of fiduciary duties, trade secret misappropriation, breach of contract, conversion, and violation of California Penal Code Section 496.
Nymox also filed an action in the Superior Court of California, County of Orange against Ascella Health LLC on November 8, 2023, but dismissed that action and re-filed in Delaware on February 12, 2024.

Related Party Transactions

The Corporations related party transactions include salaries, benefits and stock-based compensation disclosed above for the years ended December 31, 2023, 2022 and 2021.
The Corporation also entered into a long-term employment agreement with its President.
Shares sold to Related Parties (See Notes 9 and 12 above) $1,000,000
Notes payable to related party converted to shares (See Notes 9 and 12 above) 1,000,000
Compensation to officers (Value of 3 million shares owed to Paul Averback in 2023 was $1,754,513, and the value of 1.5 million shares owed to Paul Averback for back pay was $1,455,000, in which $2,053,869 was attributable to G&A, and $1,155,644 was attributable to R&D. The value of 100,000 shares to a former executive was $72,096, attributable to G&A, totalling $3,282,409) 3,282,409

Stakeholder Impact

Shareholders face the risk of further dilution and potential loss of investment.
Employees face uncertainty due to the company's financial instability.
Customers may be affected by potential delays in product development and commercialization.
Suppliers and creditors face the risk of delayed or non-payment.
The company's ability to continue research and development efforts is crucial for patients who may benefit from its potential therapies.

Next Steps

Continue pursuing regulatory approvals for NX-1207 in Denmark and the UK.
Work towards definitive studies and data review for NX-1207 as a focal treatment for certain types of cancer.
Seek additional equity or finance through private placements and/or other sources of capital.
Address material weaknesses in internal control over financial reporting.

Key Dates

Date	Description
1995-05	Nymox Pharmaceutical Corporation was incorporated under the Canada Business Corporations Act.
1995-12-18	Nymox's common shares were traded on the Montreal Exchange.
1996-12-01	Nymox's common shares began trading on the NASDAQ Stock Market.
1999-11-19	Nymox's common shares ceased trading on the Montreal Exchange.
2014-11-02	Top-line results of Phase 3 NX02-0017 and NX02-0018 U.S. clinical trials of NX-1207 for BPH at 12 months post-treatment were not statistically significant compared to placebo.
2015-03-24	The Corporation announced that it would hold a special shareholder meeting on April 15, 2015 in Montreal for a motion to transfer the Corporations head office from Montreal (Quebec) to the Bahamas.
2015-04-15	Special shareholder meeting held in Montreal to vote on transferring the Corporation's head office to the Bahamas.
2015-07-17	The Corporation approved the long-term employment agreement of Dr. Paul Averback as President and Chief Executive Officer.
2022-05-20	The Company received a Refusal to File Letter from the FDA.
2023-07-07	Nymox's common shares ceased trading on the NASDAQ Stock Market.
2023-08-09	The company entered into an agreement with an investor in a private placement of US $2.0 million for 2 million shares at a combined purchase price of $1.00 per share with 500,000 warrants.
2023-09-25	The Corporation filed a Marketing Authorization Application (MAA) with U.K. authorities.
2023-10-26	The Marketing Authorization Application (MAA) with U.K. authorities was validated and accepted for review.
2024-03-21	An application for Injunctive Relief and a Derivative Action was filed against the Company on or about October 3, 2023 in the Supreme Court of The Bahamas (Claim No. 2023/COM/com/0057). This action was terminated on March 21, 2024 in a Court Ordered Notice of Withdrawal and Discontinuance.
2024-08-29	Date of certifications by Paul Averback and Patrick A. Doody.

Keywords

NX-1207, BPH, Pharmaceutical, Regulatory Approval, Clinical Trials, Nymox, Financial Results, Biopharmaceutical

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