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 at and for the three months ended March 31, 2022 and 2021. This MD&A should be read together with the unaudited condensed interim Consolidated Financial Statements and the related notes. This MD&A is dated May 13, 2022. 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 condensed 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. reinjection 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. Topline results of the Phase 3 NX02-0017 and NX02-0018 U.S. clinical trials of NX-1207 for BPH at 12 months posttreatment 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. In March 2022, the Corporation submitted the Company’s New Drug Application (NDA) to the FDA for Fexapotide Triflutate to seek marketing approval in the U.S. for Fexapotide Triflutate for the treatment of men with benign prostatic hyperplasia (BPH). 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 topline 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 March 31, 2022 and anticipated fund from investor and planed financing 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 NX020017 and NX020018 of fexapotide triflutate (NX-1207) for BPH had successfully met the prespecified 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.
COVID-19 pandemic impact
As is generally and clearly understood, the COVID-19 pandemic has had and continues to have a major slowdown effect on worldwide business activity. Although the Company does not anticipate any fundamental change in its business plans, management does expect some degree of unavoidable slowdown due to the Company’s inherent reliance on business activities from multiple external partners, supply chains, and participation of organizations outside our control. Due to the downstream effect of these factors, it is not possible at this time to expect or to provide exact timelines for key corporate forward events. The Company cannot predict or comment on behalf of third parties (such as vendors, suppliers, partners, collaborators, etc) and their restrictions and challenges in the current business environment. However, the Company will give all relevant updates in a timely fashion.
| 2 |
Nymox works with and relies upon contract research organizations (CROs); the Company relies on external manufacturing activities (such as raw material suppliers; contract manufacturing vendors; specialized laboratory testing service providers); and works with other service providers in the life sciences and biotechnology sectors; any of the preceding which alone or in combination may lead to unanticipated delays in the Company's activities and projected timelines for milestones. In addition, Nymox relies on travel for many of its essential business activities, such as quality assurance and other undertakings, which are restricted during the current disruption. At this time there have been no material changes to any of the fundamental conclusions of our scientific research documentation and no material changes in past results in the reportable financial, or other business related disclosures. These COVID-19 related business effects and risks described above are additional to prior statements by the Company in regard to other risk factors that have been outlined in past SEC filings by the Company and are updated where and when appropriate.
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.
Differences between Bahamas and NASDAQ Corporate Governance Practices
Nymox Pharmaceutical Corporation is subject to corporate governance requirements imposed by NASDAQ because Nymox Pharmaceutical’s Shares are listed on the Nasdaq Capital Market.
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.
| 3 |
Results of Operations
Three Months Ended March 31 |
| 2022 |
|
| 2021 |
| ||
Total revenues |
| $ | - |
|
| $ | - |
|
Net loss |
| $ | (5,086,358 | ) |
| $ | (2,439,466 | ) |
Loss per share (basic & diluted) |
| $ | (0.06 | ) |
| $ | (0.03 | ) |
Results of Operations – Q1 2022 compared to Q1 2021
Net loss was $5,086,358, or $0.06 per share, for the quarter ended March 31, 2022, compared to net loss of $2,439,466, or $0.03 per share, for the quarter ended March 31, 2021. The increase of 2,646,892 in net losses for the three months ended March 31, 2022 compared to the same period in 2021 is primarily due to an increase of $ 2,908,844 in R&D expense and a decrease of $263,660 in G&A expense. The weighted average number of common shares outstanding for the three months ended March 31, 2022 was 86,026,673compared to 77,969,484 for the same period in 2021.
Revenues
Revenues from sales of goods were nil for the quarters ended March 31, 2022 and 2021 respectively.
Research and Development
Research and development expenditures were $4,334,089 for the quarter ended March 31, 2022, compared with $1,425,245 for the quarter ended March 31, 2021. Research and development expenditures mainly 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 and stock option expense charges of $63,503 in the three months ended March 31, 2022 and $167,452 in the comparative period in 2021.The increase of $2,908,844 for the quarter ended March 31, 2022 is mainly attributable to a decrease of $365,192 Lab service cost and a decrease of $103,950 in stock-based compensation charge offset with an increase of $3,117,218 NDA application fee and an increase of $119,224 in NDA related professional fee.
Marketing Expenses
Marketing expenditures were nil for the quarters ended March 31, 2022 and 2021, respectively. The Corporation expects that marketing expenditures will increase if and when new products are launched on the market.
General and Administrative Expenses
General and administrative expenses were $740,122 for the quarter ended March 31, 2022, compared with $1,003,782 for the quarter ended March 31, 2021. General and administrative expenditures also include stock compensation expense charges of $31,133 for the three months ended March 31, 2022 and $114,594 in the comparative period in 2021. The decrease of $263,660 for the quarter ended March 31, 2022 is mainly attributable a decrease of $100,000 in director compensation, a decrease of $91,762 in professional fees and a decrease of $83,461 in stock compensation charge. The Corporation expects that general and administrative expenditures will increase as new product development leads to expanded operations.
| 4 |
Finance costs
Net finance costs was $12,146 for the quarter ended March 31, 2022, compared with net finance costs of $10,439 for the quarter ended March 31, 2021. The finance costs increase of $1,707 for the quarter ended March 31, 2022 is mainly attributable to a decrease of $3,336 in interest income offset with a decrease of $2,326 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 2022 or 2021.
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 operating lease obligation as following:
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| Payments Due by Period |
| |||||||||||||
Contractual Obligations |
| Total |
|
| Less than 1 year |
|
| 1-3 years |
|
| 4-5 years |
| ||||
Operating lease and rent for office space and equipment |
| $ | 351,857 |
|
| $ | 237,681 |
|
| $ | 114,176 |
|
| $ | - |
|
Insurance premium installments |
|
| 117,819 |
|
|
| 117,819 |
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|
|
|
|
|
|
|
|
Total Contractual Obligations other than accounts payable and accrued liabilities |
| $ | 469,676 |
|
| $ | 355,500 |
|
| $ | 114,176 |
|
| $ | - |
|
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 2022 and 2021 other than those disclosed for key management personnel in note 6 of the unaudited condensed interim Consolidated Financial Statements.
Financial Position
Liquidity, Capital Resources
As of March 31,2022, cash and receivables including tax receivable totaled $682,000 compared with $843,000 at December 31, 2021.
We used cash in our operating activities in the amounts of $4,206,589 and $2,669,506 for the quarters ended March 31, 2022 and 2021, respectively. The cash used in operating activities increase is mainly attributable to NDA application fee payment of $3,117,218 in Mach, 2022.
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 February 17, 2022, the Corporation completed four retail private placements through one placement agent to various accredited investors for a total of $64,870 net proceeds after deducting placement agent fees and offering expenses. A total of 46,339 shares were issued.
| 5 |
On March 10, 2022, the Corporation completed three retail private placements through one placement agent to various accredited investors for a total of $104,674 net proceeds after deducting placement agent fees and offering expenses. A total of 58,791 shares were issued.
On March 22, 2022, the Corporation completed one private placements through one placement agent to various accredited investors for a total of $ 3,938,002 net proceeds after deducting placement agent fees and various offering expenses and a share subscription receivable of 1.9M. A total of 3,878,789 investor warrants to purchase up to an aggregate of 3,878,789 shares of common stock and a total of 193,939 placement agent warrants to purchase up to an aggregate of 193,939 shares were issued. The corporation received the share subscription funding of total 1.9M from one of the directors, James G. Robinson in April, 2022.
As of March 31, 2022, the Corporation made principal repayment of operation lease at a total of $58,520.
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 at March 31, 2022, we had an accumulated deficit of $197,648,673 and we have negative cash flows from operations. The Corporation had a negative working capital of $1,629,970 at March 31, 2022. Our current level of annual expenditures exceeds the anticipated revenues from sales of goods, however, we have cash totaling over $672 thousand at our bank as of March 31, 2022 and expect to receive share subscription fund of 1.9M in the second quatre and over 3.1M NDA application fee back.
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 March 31, 2022, 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.
| 6 |
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 and its Chief Financial Officer are responsible for establishing and maintaining disclosure controls and procedures. They are 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 and Chief Financial Officer have concluded that the disclosure controls and procedures is effective as of March 31, 2022.
TPS Thayer Company, LLC, our auditors, expressed their opinion that the effectiveness of the Corporation’s internal control over financial reporting as of December 31, 2021, was effective and their opinion was not modified in any way.
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 following remediation plan.
| • | The Corporation hired an external accounting expert, functioning in a controller’s role, at the beginning of 2017 to assist in the accounting for non-routine complex accounting matters and to enhance oversight of the financial reporting process. However, the Chief Financial Officer continued to have final say in what would be included or excluded from our financial statements and related disclosures thereto. |
| • | The accounting system was transferred to a new general ledger software system on a secure cloud platform. |
| • | Additionally, we contracted with a Managed Service Provider to maintain our IT infrastructure. |
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
Consolidated Financial Statements
(Unaudited)
Financial Statements
| Consolidated Statements of Operations (Unaudited) |
| 9 |
|
| Consolidated Statements of Financial Position (Unaudited) |
| 10 |
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| Consolidated Statements of Cash Flow (Unaudited) |
| 11 |
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| Consolidated Statements of Changes in Equity (Unaudited) |
| 12 |
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Notes to Condensed Interim Consolidated Financial Statements(Unaudited)
1. | Basis of preparation |
| 13 |
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2. | Liquidity, going concern and management’s response |
| 13 |
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3. | Share capital |
| 13 |
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4. | Earnings per share |
| 15 |
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5. | Operation lease and other commitment |
| 16 |
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6. | New Drug Application (NDA) Expense |
| 17 |
|
7. | Related party transactions |
| 17 |
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8. | Subsequent events |
| 18 |
|
| 8 |
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Operations (Unaudited)
Three month periods ended March 31, 2022 and 2021
(In Thousands of US dollars Other Than Per Share Amounts and Thousands of Shares)
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| Three months ended March 31, |
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| 2022 |
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| 2021 |
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Revenues |
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Sales of goods |
| $ |
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| $ |
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Total revenues |
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Cost of goods sold and operating Expenses |
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Cost of goods sold |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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| ( | ) |
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| ( | ) |
Other Income (expense) |
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Finance expense |
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| ( | ) |
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Finance costs |
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| ( | ) |
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| (6 | ) |
Operating lease interest expense |
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| ( | ) |
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| ( | ) |
Loss before income tax |
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| ( | ) |
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| ( | ) |
Income tax provision (recovery) |
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Net Loss |
| $ | ( | ) |
| $ | ( | ) |
Attributable to: |
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Net loss attributable to Nymox share holders |
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| ( | ) |
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| ( | ) |
Basic and diluted loss per share |
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| ( | ) |
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| ( | ) |
Weighted average number of common shares outstanding |
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See accompanying notes to the unaudited consolidated financial statements.
| 9 |
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Financial Position (Unaudited)
March 31, 2022 and December 31, 2021
(In Thousands of US Dollars and Thousands of Shares)
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| March 31, |
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| December 31, |
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ASSETS |
| Note |
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| 2022 |
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| 2021 |
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Current assets |
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Cash at bank |
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| $ |
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| $ |
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Other receivables |
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Inventory |
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Security deposit |
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Prepaid expenses and other current assets |
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Total current assets |
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Non-current assets |
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Property and equipment |
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Operating lease right-of-use asset, net |
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| 5 |
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Total assets |
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| $ |
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| $ |
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LIABILITIES AND EQUITY |
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Current liabilities |
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Accounts payable and accrued liabilities |
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| $ |
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| $ |
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Operating lease liability due within one year |
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| 5 |
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Total current liabilities |
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Long term operating lease liability |
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| 5 |
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Total liabilities |
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Equity |
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Share capital – unlimited authorized shares at no par value |
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| 3 |
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Share capital subscription receivable |
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| ( | ) |
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| ( | ) |
Additional paid-in capital |
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| 3 |
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Accumulated deficit |
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| ( | ) |
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| ( | ) |
Total Stockholders’ equity |
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| ( | ) |
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| ( | ) |
Total liabilities and stockholders’ equity |
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| $ |
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| $ |
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See accompanying notes to the unaudited consolidated financial statements.
| 10 |
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Cash Flows (Unaudited)
Three-month periods ended March 31, 2022 and 2021
(In Thousands of US Dollars)
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| Three months ended March 31, |
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| 2022 |
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| 2021 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments for: |
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Stock-based compensation |
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Depreciation |
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Amortization and others |
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Changes in non-cash operating balances: |
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Accounts receivable and other receivables |
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Prepaid expense |
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Inventory |
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Accounts payable and accrued liabilities |
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Net cash used in operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Purchase of property and equipment |
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| ( | ) | |
Net cash flows used in investing activities |
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| - |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Proceeds from the issuance of share capital &warrants |
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Repayment of operating lease and financing obligation |
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| ( | ) |
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| ( | ) |
Net cash flows used in financing activities |
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|
| ( | ) | |
Net decrease in cash and cash equivalents |
|
| ( | ) |
|
| ( | ) |
CASH AT BANK |
|
|
|
|
|
|
|
|
Beginning of the period |
|
|
|
|
|
| ||
End of the period |
| $ |
|
| $ |
| ||
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 statements
| 11 |
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Changes in Equity (Unaudited)
Three-month periods ended March 31, 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 |
|
|
|
| $ |
|
| $ | ( | ) |
| $ |
|
| $ | ( | ) |
| $ | ( | ) | |||
Share issuance for cash and share subscription |
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
| ||||
Warrant issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
Stock-based compensation and service fee |
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
| |||||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance, March 31, 2022 |
|
|
|
| $ |
|
| $ | ( | ) |
| $ |
|
| $ | ( | ) |
| $ | ( | ) | |||
Three-month period ended March 31, 2021
(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, 2020 |
|
|
|
| $ |
|
| $ | ( | ) |
| $ |
|
| $ | ( | ) |
| $ |
| ||||
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
| ||||
Net loss |
|
| – |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance, March 31, 2021 |
|
|
|
| $ |
|
| $ | ( | ) |
| $ |
|
| $ | ( | ) |
| $ | ( | ) | |||
See accompanying notes to the unaudited consolidated financial statements
| 12 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
1. | Basis of preparation: |
| (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, 2021 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 May 13, 2022. |
| (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 and stock option issued for services. |
2. | Liquidity, Going Concern and Management’s Response |
Management believes that current cash balances as of March 31, 2022 and planned fund raising is sufficient to finance the Company’s operations for at least the next 12 months. However the Company intends to seek additional equity or other financing, should the Company’s liquidity needs 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 March 18,2022, the company entered into a definitive agreement with institutional investors in a private placement of 3,878,789 shares of common stock and warrants to purchase |
| 13 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
| (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
The following table provides the activity of stock option awards during the three-month period ended March 31, 2022 and for options outstanding and exercisable at the end of the three-month period ended March 31, 2022, the weighted average exercise price and the weighted average years to expiration. |
|
|
|
| Options |
|
|
| |||||
|
|
|
| outstanding |
|
| Weighted |
| ||||
|
|
|
| Weighted |
|
| average |
| ||||
|
|
|
| average |
|
| remaining |
| ||||
|
|
|
| exercise |
|
| contractual |
| ||||
|
| Number |
|
| Price |
|
| life (in years) |
| |||
Outstanding, December 31, 2021 |
|
|
|
| $ |
|
|
|
| |||
Expired |
|
| - |
|
|
| - |
|
|
|
| |
Cancelled |
|
| - |
|
|
| - |
|
|
| - |
|
Granted |
|
| - |
|
|
| - |
|
|
|
| |
Outstanding, March 31, 2022 |
|
|
|
| $ |
|
|
|
| |||
Options exercisable |
|
|
|
| $ |
|
|
|
| |||
| 14 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
| (c) | Stock-based compensation: |
Stock -based compensation includes stock and stock option granted to employees and contractors for their service.
|
| Three months |
| |||||
|
| ended March 31, |
| |||||
Employee expense |
| 2022 |
|
| 2021 |
| ||
Stock and stock option compensation granted in |
|
|
|
|
|
| ||
2015 |
|
|
|
|
|
| ||
2020 |
|
|
|
|
|
| ||
Total stock-based compensation expense recognized |
| $ |
|
| $ |
| ||
The stock and stock option -based compensation expense is disaggregated in the statements of operations and comprehensive loss as follows:
|
| Three months |
| |||||
|
| ended March 31, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Stock-based compensation pertaining to general and administrative expenses |
| $ |
|
| $ |
| ||
Stock-based compensation pertaining to research and development expenses |
|
|
|
|
|
| ||
Total |
| $ |
|
| $ |
| ||
| (d) | Warrants: |
In the first quarter of 2019, the Corporation issued | |
| |
In the second quarter of 2021, the Corporation issued
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 | |
4. | Earnings per share: |
Weighted average number of common shares outstanding:
|
| Three months |
| |||||
|
| ended March 31, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Issued common shares at beginning of period |
|
|
|
|
|
| ||
Effect of shares issued |
|
|
|
|
|
| ||
Weighted average number of common shares outstanding – basic |
|
|
|
|
|
| ||
Weighted average number of shares outstanding – diluted |
|
|
|
|
|
| ||
| 15 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
There is no difference in diluted as compared to basic earnings per share as the impact would be antidilutive as a result of the net loss.
5. | Operating lease and other commitments |
Effective for annual reporting periods beginning on or after January 1, 2019, IFRS 16 introduced a new approach to lessee accounting that requires a lessee to recognize assets and liabilities for the rights and obligations created by leases. IFRS 16 requires a lessee to recognize assets and liabilities for all leases with a term of more than 12 months. The IASB concluded that such an approach will result in a more faithful representation of a lessee’s assets and liabilities and, together with enhanced disclosures, greater transparency of a lessee’s financial leverage and capital employed.
We adopted this standard on January 1, 2019, with an immaterial cumulative adjustment of $
The following table provides the changes in the Corporation’s operating lease right-of-use assets for the three months ended March 31, 2022 and 2021 respectively:
(amounts in dollars) |
| Total |
| |
Balances as of January 1, 2022 |
| $ |
| |
Renewed office lease |
|
|
| |
Accumulated amortization |
|
| ( | ) |
Balances as of March 31, 2022 |
| $ |
| |
(amounts in dollars) |
| Total |
| |
Balances as of January 1, 2021 |
| $ |
| |
Renewed office lease |
|
|
| |
Accumulated amortization |
|
| ( | ) |
Balances as of March 31, 2021 |
| $ |
| |
The following table provides the changes in the Corporation’s operating lease liability for the three months ended March 31, 2022 and 2021 respectively:
(amounts in dollars) |
| Total |
| |
|
|
|
| |
Balances as of January 1, 2022 |
| $ |
| |
Renewed office lease |
|
|
| |
Repayments of lease liability |
|
| ( | ) |
Other |
|
|
| |
Balances as of March 31, 2022 |
| $ |
| |
Lease liability due within one year |
| $ |
| |
Lease liability long term |
| $ |
| |
| 16 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
(amounts in dollars) |
| Total |
| |
|
|
|
| |
Balances as of January 1, 2021 |
| $ |
| |
Renewed office lease |
|
|
| |
Repayments of lease liability |
|
| ( | ) |
Other |
|
|
| |
Balances as of March 31, 2021 |
| $ |
| |
Lease liability due within one year |
| $ |
| |
Lease liability long term |
| $ |
| |
The total future commitment payment amount for above lease is $
In addition to the lease commitment, the corporation has a future insurance premium payment and copier rent of $
6. | New Drug Application (NDA) Expense |
In March,2022, the Company submitted it’s New Drug Application (NDA) to the FDA for Fexapotide Triflutate to seek marketing approval in the U.S. for Fexapotide Triflutate for the treatment of men with benign prostatic hyperplasia (BPH). The company paid a total of $
7. | Related Party Transactions: |
The transactions we have with related parties include compensation arrangements for current compensation, share based compensation , and compensation under options, and share purchase as investor.
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 |
| |||||
|
| ended March 31, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Salaries and bonus |
| $ |
|
| $ |
| ||
Short-term employee benefits |
|
|
|
|
|
| ||
Stock-based compensation |
|
|
|
|
|
| ||
|
| $ |
|
| $ |
| ||
| 17 |
NYMOX PHARMACEUTICAL CORPORATION |
Notes to Unaudited Consolidated Financial Statements |
(in US dollars) |
Total honorariums to the independent directors of the Corporation for participating in Board and Committee meetings were nil for the period ended March 31, 2022 and 2021, respectively.
Our Chief Financial Officer receives no salary compensation as an individual and receives no deferred or incentive compensation. We do make payments based on contract for services rendered to a corporation controlled by him. Amounts paid under this arrangement were $
Our Corporate Legal Counsel receives no salary compensation as an individual and receives no deferred or incentive compensation. We do make payments based on contract for services rendered to a corporation controlled by him. Amounts paid under this arrangement were $
One of directors, James G. Robinson, purchased
8. | Subsequent events: |
The Corporation has evaluated subsequent events through May 13, 2022, 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.
On April 29,2022, the Corporation received share capital subscription receivable of
| 18 |