EXHIBIT 99.1

 

MANAGEMENT’S DISCUSSION AND ANALYSIS

(in US dollars)

 

This is Management’s discussion and analysis (“MD&A”) comments on the Corporation’s operations, performance and financial condition as of and for the three and nine months ended September 30, 2023 and 2022. This MD&A should be read together with the unaudited interim Consolidated Financial Statements and the related notes. This MD&A is dated November 14, 2023. All amounts in this report are in U.S. dollars, unless otherwise noted.

 

Except as otherwise indicated, all financial information contained in this MD&A and in the unaudited condensed interim Consolidated Financial Statements has been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). The unaudited interim Consolidated Financial Statements and this MD&A were reviewed by the Corporation’s Audit Committee and were approved by our Board of Directors.

 

Additional information about the Corporation can be obtained on EDGAR at www.sec.gov or on SEDAR at www.sedar.com.

 

Overview

 

Corporate Profile

 

Nymox Pharmaceutical Corporation is a biopharmaceutical company focused on developing its drug candidate, NX-1207, for the treatment of BPH and the treatment of low-grade localized prostate cancer. Since 1989, the Corporation’s activities and resources have been directed primarily on developing certain pharmaceutical technologies. Since 2002, Nymox has been developing its novel proprietary drug candidate, NX-1207, for the treatment of benign prostatic hyperplasia (“BPH”). NX-1207 showed positive results for the treatment of BPH in Phase 1 and 2 clinical trials in the U.S. and in follow-up studies of available subjects from the completed clinical trials. In 2009, Nymox started two pivotal double blind placebo controlled Phase 3 trials for NX-1207, NX02-0017 and NX02-0018, that were conducted at investigational sites across the U.S. with a total enrollment of approximately 1,000 patients. Nymox also initiated subsequent open-label U.S. re-injection Phase 3 safety studies, NX02-0020 and NX02-0022. The NX02-0017 study completed patient enrollment and participation in December 2013 and the NX02-0018 study in May 2014. Top-line results of the 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.

 

The Corporation is in the process of further data analysis and assessments of the two studies, and expects to continue its efforts to work on the development program. Nymox is also developing NX-1207 for the treatment of low-grade localized prostate cancer. A Phase 2 study of NX-1207 for low grade localized prostate cancer was started in 2012 with positive results reported in 2014. The Corporation is in the process of working towards definitive studies for this indication. The Corporation also has an extensive patent portfolio covering its marketed products, its investigational drug as well as other therapeutic and diagnostic indications. Nymox developed the AlzheimAlert™ test, which is certified with a CE Mark in Europe. Nymox developed and markets NicAlert™ and TobacAlert™; which are tests that use urine or saliva to detect use of and exposure to tobacco products. NicAlert™ has received clearance from the FDA and is also certified with a CE Markin Europe. TobacAlert™ is the first test of its kind to accurately measure second and third hand smoke exposure in individuals.

 

 
1

 

 

In order to achieve its business plan and the realization of its assets and liabilities in the normal course of operations, the Corporation anticipates the need to raise additional debt or capital in the near term and/or achieve sales and other revenue-generating activities. Management has taken steps to reduce expenditures going forward in the short term by staff reductions, deferral of management salaries, and operational changes.

 

The top-line failure of the two Phase 3 studies of NX-1207 for BPH materially affects the Corporation’s current ability to fund its operations, meet its cash flow requirements, realize its assets and discharge its obligations. Management believes that current cash balances as of September 30, 2023 will be sufficient to meet the Company’s cash needs for the next 12 months.

 

We have incurred operating losses throughout our history. 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.

 

On July 27, 2015 Nymox announced initial clinical results from its ongoing analysis and assessment of its Phase 3 development program in BPH. The Company announced that the U.S. long-term extension prospective double-blind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH had successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies. As a result of the clinical benefits observed in the long-term extension trial, the Company announced that it intends to meet with regulatory authorities in various jurisdictions around the world and in due course explore the possibility to proceed to file for approval where possible.

 

On August 2, 2018, the Corporation opened its new office in Irvine, California. The Corporation has maintained all Quality Assurance activities from this office.

 

 Forward Looking Statements

 

Certain statements included in this MD&A may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities legislation and regulations, and are subject to important risks, uncertainties and assumptions. This forward-looking information includes amongst others, information with respect to our objectives and the strategies to achieve these objectives, as well as information with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “plan”, “foresee”, “believe” or “continue” or the negatives of these terms or variations of them or similar terminology. We refer you to the Corporation’s filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, as well as the “Risk Factors” section of this MD&A, and of our Form 20-F, for a discussion of the various factors that may affect the Corporation’s future results. The results or events predicted in such forward-looking information may differ materially from actual results or events.

 

 
2

 

 

Differences between Bahamas, NASDAQ, and OTC Pink Corporate Governance Practices

   

Nymox Pharmaceutical Corporation is subject to corporate governance requirements imposed by NASDAQ because Nymox Pharmaceutical’s Shares were listed on the Nasdaq Capital Market, and now are listed on the Over-the-Counter (“OTC”) Pink, as of July 7, 2023.  The corporate governance requirements imposed by OTC Pink are different from, and less stringent than those imposed by NASDAQ, but since Nymox Pharmaceutical’s Shares were listed on NASDAQ for at least a portion of this reporting period, this quarterly report is made with reference to the corporate governance requirements imposed by NASDAQ.

 

Nymox Pharmaceutical Corporation is incorporated in the Bahamas. Under NASDAQ Marketplace Rule 5615(a)(3), NASDAQ-listed non-US companies may, in general, follow their home country corporate governance practices in lieu of certain NASDAQ corporate governance requirements. A NASDAQ-listed non-U.S. company is required to provide a general summary of the significant differences between its home country corporate governance practices and NASDAQ corporate governance requirements to its shareholders, either in the company’s annual report filed on Form 20-F or on the company’s website. Nymox is committed to a high standard of corporate governance. As such, Nymox endeavors to comply with most of the NASDAQ corporate governance practices, with the following exceptions. Under NASDAQ Marketplace Rule 5635(c), shareholders must be given the opportunity to vote on any material amendment to the terms of a company’s equity compensation plan (i.e., an amendment to the plan to include repricing provisions). There is no requirement under Bahamas law that equity compensation plan, or any material amendment thereto, be subject to shareholder approval. Nymox will continue to follow the Bahamas practice and require any material amendment to the terms of its plan to be subject only to approval by its board of directors.

 

Also under NASDAQ Marketplace Rule 5635(d), shareholders must be given the opportunity to vote prior to the issuance of securities in connection with a transaction other than a public offering involving: (1) the sale, issuance or potential issuance by the Company of common stock (or securities convertible into or exercisable for common stock) at a price less than the greater of book or market value which together with sales by officers, directors or substantial shareholders of the Company equals 20% or more of common stock or 20% or more of the voting power outstanding before the issuance; or (2) the sale, issuance or potential issuance by the Company of common stock (or securities convertible into or exercisable common stock) equal to 20% or more of the common stock or 20% or more of the voting power outstanding before the issuance for less than the greater of book or market value of the stock. There is no requirement under Bahamas law that stock issuances pursuant to private placements be subject to shareholder approval. Nymox will continue to follow the Bahamas practice and require private placement transactions to be subject only to approval by its board of directors.

 

Results of Operations

 

Nine Months Ended September 30

 

2023

 

 

2022

 

Total revenues

 

$-

 

 

$-

 

Net loss

 

$(3,533,113 )

 

$(5,236,774 )

Loss per share (basic & diluted)

 

$(0.04 )

 

$(0.06 )

 

Results of Operations – the three and nine months ended September 30, 2023 compared to the three and nine months ended September 30, 2022

 

Net losses were $1,036,158, or $0.01 loss per share, for the quarter, and $3,533,113, or $0.04 loss per share, for the nine months ended September 30, 2023, compared to net losses $1,490,983, or $0.02 loss per share, for the quarter, and $5,236,774, or $0.06 loss per share, for the nine months ended September 30, 2022.  The $1,703,661 decrease in net losses for the nine months ended September 30, 2023 compared to the same period in 2022 is due to a decrease of $4,061,832 in R&D expense, a decrease of $765,893 in G&A expense offset with a decrease of $3,117,218 in other income related to NDA application fee refund.  The $454,825 decrease in net losses for the quarter ended September 30, 2023 compared to same period in 2022 is mainly due to a decrease of $231,281 in R&D expense and a decrease of $ 232,913 in G&A expense. The weighted average number of common shares outstanding for the three and nine months ended September 30, 2023 were 92,156,444 and 91,653,418 respectively, compared weighted average number of common shares of 91,265,140 and 89,256,437 respectively for the three and nine months ended September 30, 2022.

 

 
3

 

 

Revenues

 

Revenues from sales of goods were nil for the quarter, and for the nine months ended September 30, 2023 and 2022, respectively.

 

Research and Development

 

Research and development expenditures were $661,078 for the quarter, and $1,974,552 for the nine months ended September 30, 2023, compared with $892,360 for the quarter, and $6,036,384 for the nine months ended September 30, 2022. Research and development expenditures include costs incurred in advancing Nymox’s BPH product candidate NX-1207 through clinical trials, as well as costs related to its R&D pipeline. Research and development expenditures also include stock compensation charges of $10,790 for the quarter and $75,528 in the nine months ended September 30, 2023 compared with $32,369 for the same quarter in 2022, and $140,482 for the nine months ended September 30, 2022. The $4,061,832 decrease in R&D expense for the nine months ended September 30, 2023 compared to the same period in 2022 is mainly due to a decrease of $3,117,218 in NDA application fee, a decrease of $440,468 in professional fees and a decrease of $ 219,320 in lab expense.  The $231,281 decrease in R&D expense for the quarter ended September 30, 2023 compared to same period in 2022 is mainly due to a decrease of $53,930 in lab service expenditure, a decrease of $69,465 in professional fee, a decrease of $69,000 in employee compensation and a decrease of $21,579 in stock based compensation.

 

Marketing Expenses

 

Marketing expenditures were nil for the quarters and for the nine months ended September 30, 2023 and 2022, respectively. The Corporation expects that marketing expenditures will increase when new products are launched on the market.

 

 General and Administrative Expenses

 

General and administrative expenses were $353,161 for the quarter, and $1,522,910 for the nine months ended September 30, 2023, compared with $586,074 for the same quarter in the prior year, and $2,288,803 for the nine months ended September 30, 2022. General and administrative expenditures included stock compensation charges of $0 for the quarter, and $37,096 for the nine months ended September 30, 2023 compared with $0 and 368,151 in the comparative periods in 2022. The decrease of $765,893 in general and administrative expenses for the nine month period is primarily attributable to a decrease of $331,056 in stock compensation charges and a decrease of $436,363 in professional fees. The decrease in general and administrative expenses of $232,913 for the quarter ended September 30, 2023 is mainly attributable to a decrease of $152,910 in professional fees and a decrease of $15,227 in stock compensation charges compared to 2022. The Corporation expects that general and administrative expenditures (exclusive of stock compensation costs) will increase as new product development leads to expanded operations.

 

Finance costs

 

Net finance costs were $21,919 for the quarter and $35,652 for the nine months ended September 30, 2023, compared with net finance costs of $12,550 for the quarter and $28,805 for the nine months ended September 30, 2022. The finance costs increase of $6,847 for the nine months ended September 30, 2023 is mainly attributable to a decrease of $9,705 in operation lease interest expense offset with an increase of $15,486 in finance charges,

 

The Corporation incurs expenses in the local currency of the countries in which it operates, which include the United States, Canada and the Bahamas. Foreign exchange fluctuations had no meaningful impact on the Corporation’s results in 2023 or 2022.

 

 
4

 

 

Inflation

 

The Corporation does not believe that inflation has had a significant impact on its results of operations.

 

Contractual Obligations

 

Nymox has no contractual obligations of significance other than its accounts payable, accrued liabilities and the following:

 

Contractual Obligations

 

Total

 

 

Less than 1 year

 

 

1-3 years

 

 

4-5 years

 

Operating lease for office space and equipment

 

$11,082

 

 

$11,082

 

 

$0

 

 

$0

 

Insurance premium installment

 

 

141,428

 

 

 

141,428

 

 

 

0

 

 

 

0

 

Total Contractual Obligations other than accounts payable and accrued liabilities

 

$152,510

 

 

$152,510

 

 

$0

 

 

$0

 

 

Off-Balance Sheet Arrangements

 

The Corporation has no binding commitments for the purchase of property, equipment or intellectual property. Effective for annual reporting periods beginning on January 1, 2019, IFRS 16 introduces a new approach to lessee accounting that requires a lessee to recognize assets and liabilities for the rights and obligations created by lease. IFRS 16 requires a lessee to recognize assets and liabilities for all leases with a term of more than 12 months and for which the underlying asset value is not of low value. The Corporation adopted IFRS 16 on January 1, 2019. The corporation has no commitments that are not reflected in the statement of financial position except for insurance premium installments and copier rent.

 

Transactions with Related Parties

 

The Corporation had no transactions with related parties in 2023 and 2022 other than those disclosed for key management personnel in note 7 of the unaudited condensed interim Consolidated Financial Statements.

 

Financial Position

 

Liquidity and Capital Resources

 

As of September 30, 2023, cash and receivables totaled $84,000 compared with $1,413,000 at December 31, 2022.

 

We used cash in our operating activities in the amounts of $3,160,826 and $3,956,487 for the nine months ended September 30, 2023 and 2022, respectively.

 

Investing activities have been insignificant and substantially all cash flows have been provided by financing activities, specifically proceeds from the issuance of common stock.

 

On April 17, 2023, we signed a short-term loan agreement with a related party for $1,000,000, of which $500,000 was received on April 25, 2023, $250,000 was received on June 5, 2023 and $250,000 was received on July 3, 2023.  The total of outstanding loan was paid and settled in full on August 28, 2023.

 

On August 9, 2023, 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. The investor warrants have an excise price of $2.00 per share, are immediately excisable and will expire 6 years from the effective date. The investment comes from James Robinson, a long-term shareholder of Nymox and a distinguished member of the Board of Directors of the Company. The funds will be used for general corporate purposes.

 

 
5

 

 

The private placement was completed on August 29, 2023, and the company raised $2,000,000.

 

As of September 30, 2023, the Corporation made the principal repayment of the operating lease at $163,053.

 

We have incurred substantial operating losses since our inception due in large part to expenditures for our research and development activities and expense charges related to the issuance of stock and stock options to our key employees. As of September 30, 2023, we had an accumulated deficit of $202,671,349 and we have negative cash flows from operations. The Corporation’s had a negative working capital of $1,916,614, at September 30, 2023. Our current level of annual expenditures exceeds the anticipated revenues from sales of goods.  However, we are working on securing short term loan and investment funds from investors. We already secured a short-term loan on October, 2023.

 

Management has implemented steps to reduce expenditures, including deferral of management salaries, and other operational changes. There is no assurance these actions will be successful; however management believes the use of the going concern assumption is appropriate.

 

The unaudited interim consolidated financial statements for the three months ended September 30, 2023, do not include any adjustments or disclosures that may be necessary should the Corporation not be able to continue as a going concern. Should the going concern assumption not be appropriate, then adjustments may be necessary to the carrying value and classification of assets and liabilities and reported results of operations and such adjustments could be material.

 

Capital disclosures

 

The Corporation’s objective in managing capital is to ensure a sufficient liquidity position to finance its research and development activities, general and administrative expenses, working capital and overall capital expenditures, including those associated with patents. The Corporation makes every attempt to manage its liquidity to minimize shareholder dilution when possible.

 

The capital management objectives remain the same as for the previous fiscal year. When possible, the Corporation tries to optimize its liquidity needs by non-dilutive sources, including sales, collaboration agreements, and interest income. The Corporation’s general policy on dividends is to retain cash to keep funds available to finance its research and development and operating expenses.

 

The Corporation is not subject to any capital requirements imposed by external parties other than the Nasdaq Capital Market requirements related to the Listing Rules.

 

Disclosure Controls and Procedures

 

Disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed is accumulated and communicated to senior management on a timely basis so that appropriate decisions can be made regarding public disclosure. The Corporation’s Chief Executive Officer is responsible for establishing and maintaining disclosure controls and procedures. He is assisted in this responsibility by the Corporation’s audit committee. Based on an evaluation of the Corporation’s disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934 and National Instrument 52-109), the Chief Executive Officer has concluded that the disclosure controls and procedures are effective as of August 11, 2023.

 

 
6

 

 

Changes in Internal Controls over Financial Reporting

 

We have made significant improvements in Internal Controls over Financial Reporting since year 2017.

 

Management believes that proper segregation of duties is critical to a properly designed and operating internal control environment for financial reporting. The Corporation developed a remediation plan, with oversight from the Audit Committee, to remediate the following material weaknesses in internal controls over financial reporting, first identified in 2015.

 

The Corporation did not employ a sufficient complement of finance and accounting personnel to ensure that there was proper segregation of duties related to certain processes, primarily impacting the expenditures/disbursements processes and information technology general controls (“ITGC”) and sufficient compensating controls did not exist in these areas. To improve the weakness in these areas, the Corporation has implemented a remediation plan.

   

Internal control over financial reporting has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate this risk.

 

 
7

 

 

NYMOX PHARMACEUTICAL CORPORATION

Condensed Interim Consolidated Financial Statements

(Unaudited)

 

Financial Statements

 

Consolidated Statements of Operations (Unaudited)

 

 

9

 

Consolidated Statements of Financial Position as of September 30, 2023 and December 31, 2022 (Unaudited)

 

 

10

 

Consolidated Statements of Cash Flows (Unaudited)

 

 

11

 

Consolidated Statements of Changes in Equity (Unaudited)

 

 

12

 

 

Notes to Interim Consolidated Financial Statements (Unaudited) 

1.

Business Activities and Basis Of Presentation

 

13

 

2.

Going concern considerations

 

14

 

3.

Share capital

 

14

 

4.

Earnings per share

 

16

 

5.

Operating lease and other commitments

17

 

6.

Short term loan

 

18

 

7.

Commitments and Contingencies

 

18

 

8.

Related party transactions

 

19

 

9.

Subsequent event

 

19

 

 
8

 

 

NYMOX PHARMACEUTICAL CORPORATION

Consolidated Statements of Operations (Unaudited)

Three and Nine-month periods ended September 30, 2023 and 2022

(In Thousands of US dollars Other Than Per Share Amounts and Thousands of Shares )

 

 

 

 

 

 

Three months ended

September 30,

 

 

Nine months ended

September 30,

 

 

 

Note

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales of goods

 

 

 

 

 

$-

 

 

$-

 

 

$-

 

 

$5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

 

 

661

 

 

 

892

 

 

 

1,974

 

 

 

6,036

 

General and administrative

 

 

 

 

 

 

353

 

 

 

586

 

 

 

1,523

 

 

 

2,289

 

Marketing

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Cost of sales

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

 

 

 

 

 

1,014

 

 

 

1,478

 

 

 

3,497

 

 

 

8,325

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

 

 

 

 

(1,014)

 

 

(1,478)

 

 

(3,497)

 

 

(8,325)

Other Income/Expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,117

 

Operating lease and financial obligations

 

 

 

 

 

 

-

 

 

 

(3)

 

 

(3)

 

 

(13)

Interest income (cost)

 

 

 

 

 

 

(22)

 

 

(10)

 

 

(33)

 

 

(16)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax

 

 

 

 

 

$(1,036)

 

$(1,491)

 

$(3,533)

 

$(5,237)

Income tax provision (recovery)

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss

 

 

 

 

 

 

(1,036)

 

 

(1,491)

 

 

(3,533)

 

 

(5,237)

Net income(loss) per share Basic and dully diluted

 

 

4

 

 

 

(0.01)

 

 

(0.02)

 

 

(0.04)

 

 

(0.06)

Weighted average number of common shares outstanding

 

 

4

 

 

$92,156

 

 

$91,265

 

 

$91,653

 

 

$89,256

 

 

See accompanying notes to the unaudited consolidated financial statements.

 

 
9

 

 

NYMOX PHARMACEUTICAL CORPORATION

Consolidated Statements of Financial Position (Unaudited) September 30, 2023 and December 31, 2022

(In Thousands of US dollars and Thousands of Shares)

 

 

 

 

 

 

September 30,

 

 

December 31,

 

 

 

Note

 

 

2023

 

 

2022

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Cash at bank

 

 

2

 

 

$76

 

 

$1,403

 

Other receivables

 

 

 

 

 

 

7

 

 

 

10

 

Security deposit

 

 

 

 

 

 

28

 

 

 

28

 

Prepaid expenses and other current assets

 

 

 

 

 

 

543

 

 

 

16

 

Total current assets

 

 

2

 

 

 

654

 

 

 

1,457

 

Non-current assets

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment

 

 

 

 

 

 

5

 

 

 

10

 

Operating lease right-of-use asset, net

 

 

 

 

 

 

10

 

 

 

158

 

Total assets

 

 

 

 

 

$669

 

 

$1,625

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

 

 

 

 

$2,560

 

 

$1,934

 

Short term loan

 

 

 

 

 

 

-

 

 

 

-

 

Operating lease liability due within one year

 

 

 

 

 

 

11

 

 

 

173

 

Total current liability

 

 

 

 

 

 

2,571

 

 

 

2,107

 

Long term operating lease liability

 

 

 

 

 

 

-

 

 

 

-

 

Total liabilities

 

 

 

 

 

 

2,571

 

 

 

2,107

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

Share capital – unlimited authorized shares at no par value 93,265 and 90,515 shares outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

3

 

 

 

173,353

 

 

 

171,671

 

Additional paid-in capital

 

 

3

 

 

 

27,416

 

 

 

26,985

 

Accumulated deficit

 

 

 

 

 

 

(202,671 )

 

 

(199,138 )

Total stockholders’ equity

 

 

3

 

 

 

(1,902)

 

 

(482 )

 

 

 

 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

 

 

 

 

$669

 

 

$1,625

 

 

See accompanying notes to the unaudited consolidated financial statements.

 

 
10

 

 

NYMOX PHARMACEUTICAL CORPORATION

Consolidated Statements of Cash Flows (Unaudited)

Nine-month periods ended September 30, 2023 and 2022

(In Thousands of US Dollars)

 

 

 

Note

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

$(3,533 )

 

$(5,237 )

Adjustments for:

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

3(c)

 

 

 

113

 

 

 

509

 

Depreciation

 

 

 

 

 

 

8

 

 

 

9

 

Amortization and others

 

 

 

 

 

 

150

 

 

 

179

 

Changes in non-cash operating balances:

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable and other receivables

 

 

 

 

 

 

3

 

 

 

3

 

Prepaid expenses and other current assets

 

 

 

 

 

 

(527 )

 

 

(3)

Accounts payable and accrued liabilities

 

 

 

 

 

 

626

 

 

 

584

 

Net cash flows used in operating activities

 

 

 

 

 

 

(3,160 )

 

 

(3,956 )

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

 

 

 

 

(3 )

 

 

-

 

Net cash flows used in investing activities

 

 

 

 

 

 

(3 )

 

 

-

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from issuance of share capital

 

 

 

 

 

 

2,000

 

 

 

6,007

 

Proceeds from short term loan

 

 

 

 

 

 

1,000

 

 

 

-

 

Repayment of short term loan

 

 

 

 

 

 

(1,000

)

 

 

 

 

Repayment of operating lease and financing obligation

 

 

 

 

 

 

(164 )

 

 

(177 )

Net cash flows provided by financing activities 

 

 

 

 

 

 

1,836

 

 

 

5,830

 

Net increase (decrease) in cash and cash equivalents

 

 

 

 

 

 

(1,327 )

 

 

1,874

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH AT BANK

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of the period

 

 

 

 

 

 

1,403

 

 

 

830

 

End of the period

 

 

 

 

 

 

76

 

 

 

2,704

 

Supplemental Disclosure

 

 

 

 

 

$-

 

 

$-

 

NON-CASH INVESTING AND FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease right-of-use asset and related liability

 

 

 

 

 

$-

 

 

$-

 

 

See accompanying notes to the unaudited consolidated financial statement.

 

 
11

 

 

NYMOX PHARMACEUTICAL CORPORATION

Consolidated Statements of Changes in Equity (Unaudited)

Nine-month period ended September 30, 2023 and 2022

(In Thousands of US dollars and Thousands of Shares)

 

Nine-month period ended September 30, 2023

(In Thousands of US dollars and Thousands of Shares)

 

 

 

Common

Shares

 

 

Dollars

 

 

Share capital subscription

 

 

Additional

paid-in

capital

 

 

Accumulated Deficit

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2022

 

 

90,515

 

 

$171,671

 

 

$-

 

 

$26,985

 

 

$(199,138 )

 

$(482 )

Share and warrants issuance for cash

 

 

2,000

 

 

 

1,682

 

 

 

-

 

 

 

318

 

 

 

-

 

 

 

2,000

 

Stock-based compensation and service fee

 

 

750

 

 

 

-

 

 

 

-

 

 

 

113

 

 

 

-

 

 

 

113

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,533 )

 

 

(3,533 )

Balance, September 30, 2023

 

 

93,265

 

 

 

173,353

 

 

$-

 

 

$27,416

 

 

$(202,671 )

 

$(1,902)

 

Nine-month period ended September 30, 2022

(In Thousands of US dollars and Thousands of Shares)

 

 

 

Common

Shares

 

 

Dollars

 

 

Share

capital

subscription

 

 

Additional

paid-in

capital

 

 

Accumulated

Deficit

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2021

 

 

85,546

 

 

$165,061

 

 

$(589 )

 

$27,584

 

 

$(192,562 )

 

$(506 )

Share issuance for cash and share subscription

 

 

3,984

 

 

 

4,834

 

 

 

-

 

 

 

(568 )

 

 

-

 

 

 

4,266

 

Warrants issued

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,741

 

 

 

 

 

 

 

1,741

 

Stock-based compensation and service fee

 

 

1,735

 

 

 

2,365

 

 

 

-

 

 

 

(1,856 )

 

 

-

 

 

 

509

 

Net loss

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,237 )

 

 

(5,237 )

Balance, September 30, 2022

 

 

91,265

 

 

 

172,260

 

 

$(589 )

 

$26,901

 

 

$(197,799 )

 

$773

 

 

See accompanying notes to the unaudited interim consolidated financial statements.

 

 
12

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

1. Business Activities and Basis Of Presentation: 

 

Nymox Pharmaceutical Corporation is a company which re-domiciled from Canada to the Commonwealth of The Bahamas in 2015 and is incorporated under the International Business Companies Act of the Commonwealth of The Bahamas.Nymox Pharmaceutical Corporation including its whole owned subsidiaries, Nymox Corporation, a Delaware Corporation, and Serex Inc. of New Jersey (together referred to as the “Corporation”), is a biopharmaceutical corporation, which specializes in the research and development of products for the aging population. The head office of the Corporation is located at Bay & Deveaux Sts., 2nd Floor, Nassau, The Bahamas. Since 2002, the Corporation has been developing its novel proprietary drug candidate, NX-1207, for the treatment of benign prostatic hyperplasia (BPH) and, since 2012, for the treatment of low-grade localized prostate cancer. The Corporation also has an extensive patent portfolio covering its marketed products, its investigational drug as well as other therapeutic and diagnostic indications.

 

(a) Statement of compliance:

 

The consolidated condensed unaudited interim consolidated financial statements of the Corporation have been prepared in accordance with International Financial Reporting Standards (“IFRS”) and its interpretations as issued by the International Accounting Standards Board (“IASB”) and in accordance with IAS 34, Interim Financial Reporting. The condensed unaudited interim consolidated financial statements do not include all of the information required for full annual financial statements and accordingly should be read in conjunction with the previously issued annual financial statements of the Corporation for the fiscal year ended December 31, 2022 and notes thereto contained in the Corporation’s Annual Report on Form 20-F.

 

The consolidated condensed interim consolidated financial statements were authorized for issuance by the Board of Directors on November 14, 2023.

 

(b) Basis of measurement:

 

The condensed unaudited interim consolidated financial statements have been prepared on a going concern and on the historical cost basis. The functional currency of the Corporation is the US dollar.

 

(c) Use of estimates and judgments:

 

The preparation of the consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, income and expenses. Information about critical judgments in applying accounting policies and assumption and estimation uncertainties that have the most significant effect on the amounts recognized in the consolidated financial statements is noted below: Significant estimates include, but are not limited to, the estimation of useful lives of equipment for purposes of depreciation, useful life of lease for purpose of amortization and the valuation of common shares, stock option, and warrant issued for private placement or services.

  

 
13

 

    

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

2. Going concern considerations:

 

Management believes that current cash balances as of September 30, 2023 and planned fund raising will be sufficient to finance the Company’s operations for at least the next 12 months. However, if necessary, the Company intends to seek additional equity or other financing, should the Company’s liquidity need change. Considering recent developments and the need for additional financing, there exists a material uncertainty that casts substantial doubt about the Corporation’s ability to continue as a going concern. These financial statements do not reflect adjustments that would be necessary. If the going concern assumption is not appropriate, then adjustments may be necessary to the carrying value and classification of assets and liabilities and reported results of operations and such an adjustment could be material.

 

3. Share Capital:

 

The holders of common shares are entitled to receive dividends as declared, which is at the discretion of the Corporation, and are entitled to one vote per share at the annual general meeting of the Corporation. The Corporation has never paid any dividends.

 

(a) Private placements:

 

On August 9, 2023, 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. The investor warrants have an excise price of $2.00 per share, are immediately excisable and will expire 6 years from the effective date. The investment comes from James Robinson, a long-term shareholder of Nymox and a distinguished member of the Board of Directors of the Company. The funds will be used for general corporate purposes.

 

The private placement was completed on August 29, 2023, and the company raised $2,000,000.

 

(b) Stock options:

 

The Corporation has established a stock option plan (the “Plan”) for its key employees, its officers and directors, and certain consultants. The Plan is administered by the Board of Directors of the Corporation. The Board may from time to time designate individuals to whom options to purchase common shares of the Corporation may be granted, the number of shares to be optioned to each, and the option price per share. The option price per share cannot involve a discount to the market price at the time the option is granted. The maximum number of shares which may be optioned under the stock option plan is 15,000,000. The maximum number of shares which may be optioned to any one individual is 15% of the total issued and outstanding common shares. Options under the Plan expire ten years after the grant date and vest either immediately or over periods up to six years, and are equity-settled. As of September 30, 2023, 9,400,000 options could still be granted by the Corporation. The following table provides the activity of stock option awards during the nine-month period ended September 30, 2023 and for options outstanding and exercisable at the end of the nine-month period ended September 30, 2023, the weighted average exercise price and the weighted average years to expiration.

 

 
14

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

  

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

Range

 

 

average

 

 

 

 

 

 

of

 

 

remaining

 

 

 

 

 

 

exercise

 

 

contractual

 

 

 

Number

 

 

price

 

 

life (in years)

 

Outstanding, December 31, 2022

 

 

6,080,000

 

 

$1.76

 

 

 

2.92

 

Expired / Cancelled

 

 

(580,000 )

 

 

1.33

 

 

 

-

 

Granted

 

 

100,000

 

 

 

0.30

 

 

 

-

 

Outstanding, September 30, 2023

 

 

5,600,000

 

 

$1.78

 

 

 

1.94

 

Options exercisable

 

 

5,600,000

 

 

$1.78

 

 

 

1.94

 

 

(c) Stock-based compensation:

 

Stock -based compensation includes stock and stock option granted to employees and contractors for their service.

 

 

 

Three months

 

 

Nine months

 

 

 

ended September 30,

 

 

ended September 30,

 

Employee expenses

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Stock options and stock compensation granted in:

 

 

 

 

 

 

 

 

 

 

 

 

2015

 

 

-

 

 

 

-

 

 

 

-

 

 

 

86,749

 

2020

 

 

10,790

 

 

 

32,369

 

 

 

75,528

 

 

 

97,107

 

2022

 

 

-

 

 

 

-

 

 

 

-

 

 

324,777

 

2023

 

 

-

 

 

 

-

 

 

 

37,096

 

 

 

-

 

Total stock-based compensation expense recognized

 

$10,790

 

 

$32,369

 

 

$112,624

 

 

$508,633

 

 

 
15

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

The stock-based compensation expense is disaggregated in the statements of consolidated Statements of Operations as follows:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation pertaining to general and administrative

 

$-

 

 

$-

 

 

$37,096

 

 

$368,151

 

Stock-based compensation pertaining to research and development

 

 

10,790

 

 

 

32,369

 

 

 

75,528

 

 

 

140,482

 

Total

 

$10,790

 

 

$32,369

 

 

$112,624

 

 

$508,633

 

 

(d) Warrants : 

      

In the first quarter of 2022, the Corporation issued 3,878,789 investor warrants in connection with one private placement. Each warrant entitles the holder to acquire one common share of the Corporation at an exercise price of $2.00 with a five year term. In addition, the Company issued Placement Agent (or its assigns) warrants to purchase up to 193,939 shares of common stock at an exercise price of $2.06 per share, The Placement Agent Warrants are immediately exercisable and will expire on the five-year anniversary of the Effective Date. The warrants were recorded as part of additional paid in capital at a total of $1,877,608.  

  

On August 9, 2023, the company issued 500,000 warrants to an accredited investor in connection with one private placement. Each warrant entitles the holder to acquire one common share of the Corporation at an exercise price of $2.00. The warrant is immediately excisable and will expire 6 years from the effective date. The warrants were recorded as part of additional paid in capital at a total of $317,302

 

4. Earnings per Share: 

 

Weighted average number of common shares outstanding: 

 

 

 

Three months

 

 

Nine months

 

 

 

ended September 30,

 

 

ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Issued common shares at beginning of period

 

 

91,265,140

 

 

 

91,265,140

 

 

 

90,515,140

 

 

 

85,545,875

 

Effect of shares issued

 

 

891,304

 

 

 

-

 

 

 

1,138,278

 

 

 

3,710,562

 

Weighted average number of common shares outstanding – basic

 

 

92,156,444

 

 

 

91,265,140

 

 

 

91,653,418

 

 

 

89,256,437

 

Weighted average number of shares outstanding – diluted

 

 

92,156,444

 

 

 

91,265,140

 

 

 

91,653,418

 

 

 

89,256,437

 

 

There is no difference in diluted earning per share as compared to basic earnings per share for the all periods when the company has a net loss as the impact would be antidilutive.

 

 
16

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

5. Operating lease and other commitments

 

The following table provides the changes in the Corporation’s operating lease right-of-use assets for the nine months ended September 30, 2023 and year end of December 31, 2022 respectively:

 

(amounts in dollars)

 

Total

 

Balances as of January 1, 2023

 

$158,384

 

Renewed office lease

 

 

-

 

Accumulated amortization

 

 

(148,699 )

Balances as of September 30, 2023

 

$9,685

 

 

(amounts in dollars)

 

Total

 

Balances as of January 1, 2022

 

$383,969

 

Adjustment office lease

 

 

(4,040)

Accumulated amortization

 

 

(221,545 )

Balances as of December 31, 2022

 

$158,384

 

 

 The following table provides the changes in the Corporation’s operating lease liability for the nine months ended September 30, 2023 and year end of December 31, 2022 respectively:

 

(amounts in dollars)

 

Total

 

 

 

 

 

Balances as of January 1, 2023

 

$172,942

 

Renewed office lease

 

 

-

 

Repayments of lease liability

 

 

(164,706 )

Other

 

 

2,846

 

Balances as of September 30, 2023

 

$11,082

 

Lease liability due within one year

 

$11,082

 

Lease liability long term

 

$-

 

 

(amounts in dollars)

 

Total

 

 

 

 

 

Balances as of January 1, 2022

 

$391,459

 

Adjustment office lease

 

 

(4,040 )

Repayments of lease liability

 

 

(229,503 )

Other

 

 

15,026

 

Balances as of December 31, 2022

 

$172,942

 

Lease liability due within one year

 

$172,942

 

Lease liability long term

 

$-

 

 

 
17

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

We used an incremental borrowing rate as a discount rate for our operating leases. The discount rate is 5.00% and the average remaining years for our lease are 0.08 years as of September 30, 2023.

 

The total future commitment payment amount for above lease is $11,082. No difference comparing an outstanding lease liability of 11,082 as of September 30,2023 due to extremely short remaining lease expiration time .

 

The total future commitment payment amount for above lease is $175,910 comparing an outstanding lease liability of $172,942 as of December 31, 2022. The difference is due to interest expense.

 

6. Short term loan 

 

On April 17, 2023, the company signed a short-term loan agreement with the company’s director, James G, Robinson. The principal amount of the loan is $1,000,000. The loan amount shall be delivered in two or more payment. The loan bear interest, compound annually, at 10%. The principal amount of the loan and any accrued but unpaid interest shall be due and payable in full due on or before April 16, 2024

The company received the first loan payment of $500,000 on April 25, 2023, received $250,000 on June 5, 2023 and received $250,000 on July 3, 2023.  The short-term Loan was paid and settled in full on August 28, 2023 when the completed the private placement with Mr. Robinson.

 

7. Commitments and Contingencies 

 

The Company is subject to periodic legal or administrative proceedings in the ordinary course of business. The Company does not have any pending legal or administrative proceeding to which the Company is a party that will have a material effect on its business or financial condition other than the matters discussed below.

 

Currently the Canadian Revenue Authorities (“CRA”) is asserting that the Company owes additional taxes for the domicile move from Canada to the Bahamas. The Company disputes this allegation and is currently contesting the matter with the CRA. No resolution has been reached as of today’s date; however the Company is confident that its position will prevail.

 

 
18

 

 

NYMOX PHARMACEUTICAL CORPORATION

Notes to Unaudited Consolidated Financial Statements

Three and Nine-month periods ended September 30, 2023 and 2022

(US dollars)

 

8. Related Party Transactions:

 

The transactions we have with related parties include compensation arrangements for current compensation, share based compensation, compensation under options, share purchase as investor and short term loan from the company director.

 

Executive officers and directors participate in the Corporation’s stock option plan. Certain Executive officers are covered under the Corporation’s health plan.

 

Key management personnel compensation is comprised of:

 

 

 

Three months

 

 

Nine months

 

 

 

ended September 30,

 

 

ended September 30,

 

Description

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Salaries and bonus

 

$12,000

 

 

$150,000

 

 

$132,000

 

 

$510,000

 

Short-term employee benefits

 

 

531

 

 

 

584

 

 

 

1,518

 

 

 

1,766

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

411,526

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$12,531

 

 

$150,584

 

 

$133,518

 

 

 

923,292

 

 

Total honorariums to the independent directors of the Corporation for participating in Board and Committee meetings were nil for the period ended September 30, 2023 and 2022, respectively.

 

The former Chief Financial Officer received salary compensation as an individual in the amount of $62,500 for the period ended September 30, 2023. We also made payments based on contract for services rendered to a corporation controlled by him. Amounts paid under this arrangement were $46,066 for the period ended September 30, 2023.

 

The former Corporate Legal Counsel receives no salary compensation as an individual and receives no deferred or incentive compensation. We made payments based on contract for services rendered to a corporation controlled by him. Amounts paid under this arrangement were $141,717 for the period ended September 30, 2023 and $383,850 for the period ended September 30, 2022, respectively.

 

On April 17, 2023, we signed a short-term loan agreement with the company’s director, James G, Robinson. The principal amount of the loan is $1,000,000 of which $500,000 was received on April 25, 2023, $250,000 was received on June 5, 2023 and $250,000 was received on July 3, 2023.  The Loan was paid off and settled in full on August 28, 2023. As a result , the short-term loan balance is zero as of September 30,2023.

 

On August 9, 2023, the company entered into an agreement its director James G, Robinson 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. The investor warrants have an excise price of $2.00 per share, are immediately excisable and will expire 6 years from the effective date. The funds will be used for general corporate purposes. The private placement was completed on August 29, 2023.

 

9. Subsequent events:

 

 The Corporation has evaluated subsequent events through November 14, 2023, the date the financial statements were authorized for issuance by the Audit Committee of the Board of Directors.  The Corporation has determined there are no subsequent events except the following.

 

The April 17 Loan Agreement is re-issued as the “October 2, 2023 Loan Agreement” with the company’s director, James G, Robinson. The company received the first loan payment of $500,000 on October 11, 2023 per the agreement.

 

On October 3, 2023, third-party claimants filed in the Bahamas an Ex-Parte Notice of Application seeking temporary injunctive relief, and a separate Standard Claim Form seeking permanent relief and damages against the Corporation.  The Bahamian Court issued an Injunction Order on October 5, 2023 pursuant to the Ex-Parte Notice of Application, and subsequently granted Nymox’s Application to Stay the Order on November 3, 2023.  The Corporation is confident it will prevail in dismissing the Order, and in dismissing the permanent relief and damages sought in the Standard Claim Form.

 

On October 31, 2023, the Corporation filed in the Superior Court of California, Orange County, an Ex Parte Application for a Temporary Restraining Order (TRO) to preclude the defendants, Randall Lanham, Richard Cutler, Christoper Riley, and CRNSV, from relying on and disclosing confidential and privileged information of Nymox, and to return all Nymox documents and things that they have still refused to return.  On November 2, 2023, the Court granted the TRO in amended form, and an Order to Show Cause why a preliminary injunction should not be granted.  The Corporation is confident it will prevail on the Order to Show Cause.

 

On November 8, 2023, the Corporation filed in the Superior Court of California, Orange County, a Complaint against AscellaHealth, LLC, for unfair competition, tortious interference with prospective business interests, and declaratory relief.

 

19