ProMIS Neurosciences Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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FY2024 · Filed Mar 31, 2025
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Notes to Consolidated Financial Statements
(expressed in U.S. dollars, except share and per share amounts)
**1.**DESCRIPTION OF BUSINESS
Business Description
ProMIS Neurosciences Inc. (the “Company” or “ProMIS”) is applying its patented technology platform to build a portfolio of antibody therapies, therapeutic vaccines, and other antibody-based therapies in neurodegenerative diseases and other protein-misfolding diseases, with a focus on Alzheimer’s disease (AD), multiple system atrophy (MSA), and amyotrophic lateral sclerosis (ALS). The Company believes these diseases share a common biologic cause — misfolded versions of proteins, that otherwise perform a normal function, becoming toxic and killing neurons, resulting in disease. ProMIS’ technology platform enables drug discovery through a combination of protein biology, physics and supercomputing. ProMIS believes this platform provides a potential advantage in selectively targeting the toxic misfolded proteins with therapeutics or detecting them with diagnostics.
The Company is developing a pipeline of antibodies aimed at selectively targeting misfolded toxic forms of proteins that drive neurodegenerative diseases without interfering with the essential functions of the same properly folded proteins. The Company's product candidates are PMN310, PMN267, and PMN442. The lead product candidate is PMN310, a monoclonal antibody designed to treat AD by selectively targeting toxic, misfolded oligomers of amyloid-beta. PMN267 is our second lead product candidate targeting ALS. It has been shown in preclinical studies to selectively recognize misfolded, cytoplasmic TDP 43 aggregates without interacting with normal TDP 43. Misfolded TDP 43 is believed to play an important role in the development of ALS. In light of research suggesting that misfolded toxic a-syn is a primary driver of disease in synucleinopathies such as MSA and Parkinson’s disease, our third lead product candidate, PMN442, has shown robust binding to pathogenic a-syn oligomers and seeding fibrils in preclinical studies, with negligible binding to a-syn monomers and physiologic tetramers which are required for normal neuronal function.
The Company was incorporated on January 23, 2004 under the Canada Business Corporations Act (“CBCA”). On July 13, 2023, the Company continued its existence from a corporation incorporated under the CBCA into the Province of Ontario under the Business Corporations Act (Ontario) (“OBCA”) (“Continuance”). The Continuance was approved by the Company’s shareholders at the Company’s 2023 Annual Meeting of Shareholders held on June 29, 2023. The Company is located at 1920 Yonge Street, Toronto, Ontario. The Company’s Common Shares are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol PMN. The Company has a wholly-owned U.S. subsidiary, ProMIS Neurosciences (U.S.) Inc. (“ProMIS USA”), which was incorporated in January 2016 in the State of Delaware. As of December 31, 2024, ProMIS USA has had no material activity and has no material financial impact on the Company’s consolidated financial statements.
The success of the Company is dependent on obtaining the necessary regulatory approvals of its product candidates, marketing its products, if approved, and achieving profitable operations. The continuation of the research and development activities and the commercialization of its products, if approved, are dependent on the Company’s ability to successfully complete these activities and to obtain additional financing through a combination of financing activities and operations. It is not possible to predict either the outcome of future research and development or commercialization programs, the Company’s ability to fund these programs, or the related impact of those outcomes on the Company’s ability to continue as a going concern.
Liquidity Risk
The accompanying consolidated financial statements were prepared on a going concern basis, which assumes that the Company will continue its operations for the foreseeable future and will be able to realize its assets and discharge its liabilities in the normal course of business. To date, the Company has not generated revenues from its activities. The Company had an operating loss of $16.8 million for the year ended December 31, 2024 and an accumulated deficit of $90.7 million as of December 31, 2024 and negative cash flows from operations. Management believes these conditions raise substantial doubt about the Company’s ability to continue as a going concern within the next twelve months from the date these consolidated financial statements are issued.
The Company will require additional funding to conduct future clinical activities. The Company will seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances and licensing agreements. Although the Company has been successful in raising capital in the past, there is no assurance of success in obtaining such additional financing on terms acceptable to us, if at all, and there is no assurance that the Company will be able to enter into collaborations or other arrangements. If the Company is unable to obtain funding, it could force delays, reduce or eliminate research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect future business prospects, and the ability to continue operations.
The Company expects to incur net losses for at least the next several years as the Company advances its product candidates. The Company is actively pursuing additional financing to further develop certain of the Company’s scientific initiatives, but there is no assurance these initiatives will be successful, timely or sufficient.
**2.**BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make certain estimates, judgements and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include, but are not limited to, the accrual for research and development expenses, the valuation of warrant liabilities and embedded derivative liabilities. Actual results could differ from those estimates, and such differences could be material to the consolidated financial statements.
Segment Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in making decisions on how to allocate resources and assess performance. The Company hasone operating segment and its Chief Executive Officer serves as the CODM. Substantially all of the Company’s assets are located in Canada. Refer to additional Segment Information in Note 10.
Foreign and Functional Currency
The Company determines its functional currency as the currency of the primary economic environment in which the Company operates. To determine the primary economic environment, the Company considers salient economic factors, including cash flow indicators, expense indicators and financing indicators. Functional currency is a matter of fact, not a policy election and the Company will only reevaluate its functional currency if there is a significant change in facts and circumstances.
Prior to July 1, 2023, the Company’s functional currency was the Canadian dollar (“C$”). Translation gains and losses from the application of the United States dollar (“US$”) as the reporting currency during the period that the Canadian dollar was the functional currency were included as part of cumulative foreign currency translation adjustment, which is reported as a component of stockholders’ equity (deficit) as accumulated other comprehensive loss.
Following the Company’s voluntary delisting from the Toronto Stock Exchange in July 2023, the Company determined there was a significant change in its facts and circumstances, and completed a reassessment of its functional currency. The Company determined that, as of July 1, 2023, the Company’s functional currency had changed from the C$ to the US$. The Company reassessment included analysis of various factors, including: the Company’s cash flows and expenses denominated primarily in US$, the primary market for the Company’s Common Shares trading in US$ and a majority ownership by U.S. shareholders from financings denominated in US$. The change in functional currency was accounted for prospectively from July 1, 2023 and consolidated financial statements prior to and including the period ended June 30, 2023 were not restated for the change in functional currency.
For periods commencing July 1, 2023, monetary assets and liabilities denominated in foreign currencies are translated into US$ using exchange rates in effect at the end of the reporting period. Opening balances related to non-monetary assets and liabilities are based on prior period translated amounts, and non-monetary assets acquired, and non-monetary liabilities incurred after July 1, 2023 are translated at the approximate exchange rate prevailing at the date of the transaction. Revenue and expense transactions are translated at the approximate exchange rate in effect at the time of the transaction. Foreign exchange gains and losses are included in the consolidated statement of operations and comprehensive loss within operating expenses.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. As of December 31, 2024 and 2023, the Company did not have any material cash equivalents.
Short-term Investments
Short-term investments consist of guaranteed certificates of deposit with a maturity greater than 90 days and up to one year at the time of purchase. Accordingly, all short-term investments are classified as current assets in the accompanying consolidated balance sheets. The short-term investment is being held as collateral for the Company’s credit cards.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist of cash and short-term investments. Cash is deposited in checking and money market accounts at accredited financial institutions, which at times, may exceed federally insured limits. The short-term investment is deposited in a guaranteed certificate of deposit with an accredited financial institution that guarantees 100% of the original amount invested. As of December 31, 2024, the Company has not experienced any losses on its cash or short-term investments as a result of credit risk.
Fair Value Measurements
FASB ASC 820,Fair Value Measurements and Disclosures,(“ASC 820”) defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, as established by ASC 820, of which the first two are considered observable and the last is considered unobservable:
| ● | Level 1 – Observable inputs, such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. |
| ● | Level 2 – Inputs (other than Level 1 quoted prices) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities. |
| ● | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
The Company’s warrant liabilities and share-based compensation liability were classified as Level 3 financial instruments for the years ended December 31, 2024 and 2023.
The carrying amounts of prepaid and other current assets, short-term investments, accounts payable, and accrued expenses are generally considered to be representative of their fair value based on the short-term nature of these financial instruments.
Impairment of Long-lived Assets
The Company evaluates its long-lived assets, which consist of property and equipment and definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. No material impairments have been identified as of each of December 31, 2024 and 2023.
Property and Equipment
Property and equipment, net are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Laboratory and equipment are depreciated overtwo tofive years. Computer equipment is depreciated overtwo tothree years. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accompanying consolidated balance sheets and any resulting gain or loss is included in loss from operations in the accompanying consolidated statements of operations and comprehensive loss. Expenditures for repairs and maintenance are expensed as incurred. The Company did not have any material property and equipment as of December 31, 2024 and 2023.
Intangible Assets
Definite-lived intangible assets are stated at cost less accumulated amortization and any accumulated impairment losses. An intangible asset’s carrying amount is assessed for impairment whenever there is an indication that the asset may be impaired. The Company’s definite-lived intangible assets consist of acquired rights and patents. Intangible assets are amortized on a straight-line basis over the lesser of the life of the intangible asset or its estimated useful life, which is 15 years. The Company did not have any material intangible assets as of December 31, 2024.
Derivative Liability
The Company evaluates its convertible debt, warrants or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for in accordance with FASB ASC Topic 815,Derivatives and Hedgingand Topic 480,Distinguishing Liabilities from Equity. The result of this accounting treatment is that the fair value of the embedded derivative, if required to be bifurcated, is marked-to-market at each balance sheet date and recorded as a liability. The change in fair value is recorded in the accompanying consolidated statements of operations and comprehensive loss as a component of other income or expense. Upon conversion or exercise of a derivative instrument, the instrument is marked to fair value at the conversion date and then that fair value is reclassified to equity. The Company did not have any bifurcated derivative liabilities as of December 31, 2024.
Collaboration Arrangements
The Company may enter into collaboration arrangements with pharmaceutical and biotechnology partners. The Company analyzes its collaboration arrangements to assess whether they are within the scope of FASB ASC 808,Collaborative Arrangements,(“ASC 808”), to determine whether such arrangements involve joint operating activities performed by the parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in responsibilities of all parties in the arrangement. ASC 808 does not provide guidance on the recognition of consideration exchanged or accounting for the obligations that may arise between parties. The Company concluded that ASC Topic 730,*Research and Development,*should be applied by analogy to payments between parties during the development activities of its collaboration arrangements.
General and administrative expenses consist primarily of personnel costs including salary, bonus, employee-benefits and share-based compensation, costs incurred in development and protection of intellectual property, professional service fees, and other general overhead and facility costs, including rent, depreciation and amortization, which relate to the Company’s general and administrative functions.
Research and development expenses consist primarily of costs incurred in connection with the development and research of the Company’s platform technology, as well as discovery program expenses. The Company expenses research and development costs as incurred. These expenses include:
| ● | employee-related expenses, including salaries, related benefits and share-based compensation expense, for employees engaged in research and development functions; |
| ● | external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”), and consultants; |
| ● | the cost of acquiring, developing, and manufacturing clinical study materials; and |
| ● | Costs associated with preclinical and clinical activities and regulatory operations. |
Prepaid and Accrued Research and Development Expenses
Substantial portions of the Company’s pre-clinical development, manufacturing and clinical trials are performed by third-party laboratories, medical centers, CROs and other vendors. These vendors generally bill monthly for services performed, or bill based upon milestone achievement. For preclinical and clinical studies, the Company accrues expenses based upon estimated percentage of work completed and the remaining contract milestones. At times, the Company is obligated to make upfront payments upon execution of research and development agreements. Upfront payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are capitalized as prepaid expenses until such goods are delivered or the related services are performed. The Company estimates the period over which such services will be performed based on the terms of the agreements as well as the level of effort to be expended in each period. Sometimes the actual timing of performance or the level of effort varies from the estimate, and if that does occur, the Company will adjust the amounts recorded accordingly.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss.
Warrants
The Company issues warrants on its common shares in connection with financings as well as for compensation of intermediaries and advisors. The Company accounts for warrants as either equity instruments or as liabilities depending on the specific terms of the warrant agreements in accordance with FASB ASC Topic 815,Derivatives and Hedgingand Topic 480,Distinguishing Liabilities from Equity. When classified as equity, warrants are recorded within additional paid-in-capital at the time of issuance and are not subsequently remeasured. Warrants identified as meeting the definition of a liability are recognized as a liability and treated in accordance with the derivative liability accounting policy described above. The Company periodically reassesses the appropriateness of the classification of its financial instruments. The Company also issues pre-funded warrants, warrants exercisable for $0.01, which follow the same accounting policy as the common share warrants.
Debt Issuance Costs
Debt issuance costs are specifically identifiable costs associated with issuance of a new debt instrument. Debt issuance costs are reported on the consolidated balance sheets as a direct deduction from the face amount of the
related debt. Debt issuance costs are amortized to interest expense using the effective interest method over the term of the related debt.
Share-based Compensation
Share-based compensation expense related to share awards granted to employees, directors and non-employees is recognized based on the grant-date estimated fair values of the awards using the Black- Scholes option pricing model (“Black-Scholes”). The value is recognized as expense ratably over the requisite service period, which is generally the vesting term of the award. The Company adjusts the expense for actual forfeitures as they occur. Share based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss based on the function to which the related services are provided.
Black Scholes requires a number of assumptions, of which the most significant are expected volatility, expected option term (the time from the grant date until the options are exercised or expire) and risk-free rate. Expected volatility is determined using the historical volatility for the Company. The risk-free interest rate is based on the yield of Canadian government bonds with a remaining term equal to the expected life of the option for C$ options and based on the yield of U.S. government treasury bonds for US$ options. Expected dividend yield is zero because the Company has never paid cash dividends on common shares and the Company does not expect to pay cash dividends in the foreseeable future.
For awards with market conditions in which the award does not vest unless the market condition is met, the Company will incorporate the market condition into the award’s grant date fair value calculation and derive the expected service period using a Monte Carlo simulation. The estimated expense is recognized on a straight-line basis over the derived service period. If the market condition is satisfied during the derived service period, the remaining unrecognized expense will be recognized during the period the market condition is satisfied.
Awards of options that provide for an exercise price that is not denominated in: (a) the currency of a market in which a substantial portion of the Company's equity securities trades in, (b) the currency in which the employee's pay is denominated, or (c) the Company's functional currency, are required to be classified as liabilities. The change in the Company’s functional currency, effective July 1, 2023, resulted in the reclassification of outstanding stock options that were previously denominated in C$ from equity-classified to liability-classified options (see Note 8), which are accounted for as a share option modification in accordance with FASB’s ASC 718 –Compensation*–** Stock Compensation* (“ASC 718”). Under ASC 718, when an award is reclassified from equity to liability, if at the reclassification date the original vesting conditions are expected to be satisfied, then the minimum amount of compensation cost to be recognized is based on the grant date fair value of the original award. Fair value changes below this minimum amount are recorded in additional paid-in capital. For each reporting period after the modification date, the stock option liability is adjusted so that it equals the portion of the requisite service provided multiplied by the modified award’s fair value at the end of the reporting period. Increases in the fair value of the liability in excess of the minimum grant date compensation cost described above are recognized as share-based compensation in operating expenses in the consolidated statement of operations and comprehensive loss.
Share Issuance Costs
Common share issuance costs are incremental costs directly associated with an offering of securities. These costs typically include fees paid to bankers or underwriters, attorneys, accountants, as well as printers and other third parties. Prior to the effective date of an offering of equity securities, specific incremental costs directly attributable to a proposed or actual offering of securities may be deferred and charged against the gross proceeds of the offering. The Company capitalizes these deferred financing costs as prepaid expenses and other current assets in the accompanying consolidated balance sheets until the completion of the offering, unless the offering is abandoned, at which time the deferred financing costs will be recognized in the consolidated statements of operations and comprehensive loss. During the year ended December 31, 2023, the Company recognized general and administrative expenses of $0.8 million related to abandoned offerings and had deferred financing costs of $0.2 million related to the Company’s at-the-market offering in prepaid expenses and other current assets on the
consolidated balance sheet as of December 31, 2023. The Company hadno deferred financing costs as of December 31, 2024.
Income Taxes
The Company is a taxable entity under the Income Tax Act (Canada). Deferred income tax assets and liabilities are determined based on differences between the financial statement carrying amounts and the respective income tax bases of assets and liabilities, measured using substantively enacted income tax rates and laws that are expected to be in effect when the differences are expected to reverse. Deferred tax assets are recognized to the extent it is more likely than not that taxable income will be available against which the deferred tax asset can be utilized. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company follows the provisions of ASC 740-10,Uncertainty in Income Taxes (“ASC 740-10”). The Company has not recognized a liability as a result of the implementation of ASC 740-10. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there isno unrecognized benefit since the date of adoption. The Company hasnot recognized interest expense or penalties as a result of the implementation of ASC 740-10. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses.
Basic and Diluted Net Income (Loss) Per Share
Basic net income (loss) per common share is based upon the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per common share utilizing the treasury-stock method is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. Potentially dilutive shares result from the assumed potential exercise or conversion of securities, such as convertible debt, share options and warrants, which would result in the issuance of incremental shares of common shares. The proceeds of such exercises or conversions are assumed to have been used to repurchase outstanding stock using the treasury stock method.
Both basic and diluted net income (loss) per share calculations include financial instruments that allow for the purchase of common shares issuable for little to no consideration, including pre-funded warrants.
Emerging Growth Company Status
The Company is an Emerging Growth Company, as defined in Section 2(a) of the Securities Act of 1933, as modified by the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Recently Adopted Accounting Pronouncements
In 2023, the FASB issued ASU 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public entities to disclose significant segment expenses and other segment items. ASU 2023-07 also requires public entities to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 became effective for the annual period starting on January 1, 2024, and for the interim periods starting on January 1, 2025.
Significant segment expenses, other segment items, and measures of segment profit or loss are disclosed in Note 10.
Recently Issued Accounting Pronouncements
In 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public entities to disclose in their rate reconciliation table additional categories of information about federal, state and foreign income taxes and to provide more details about the reconciling items in some categories if items meet a quantitative threshold. ASU 2023-09 becomes effective for the annual period starting on January 1, 2025. The Company is in the process of analyzing the impact that the adoption of ASU 2023-09 will have on its income tax disclosures.
**3.**FAIR VALUE MEASUREMENTS
The following are the major categories of assets measured at fair value on a recurring basis as of December 31, 2024 and 2023:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · As of December 31, 2024 | ||||||||
| · Level 1 · Level 2 · · Level 3 · Total | ||||||||
| Assets: · · · · · · · · · · · · | ||||||||
| Short-term investments | | $33,051 | | $— | | $— | | $33,051 |
| Total assets measured at fair value | | $33,051 | | $— | | $— | | $33,051 |
| Liabilities: | | | | | ||||
| Share-based compensation liability | | $— | | $— | | $199,263 | | $199,263 |
| Warrant liability | | $— | | $— | | $5,592 | | $5,592 |
| Total liabilities measured at fair value | | $— | | $— | | $204,855 | | $204,855 |
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · As of December 31, 2023 | ||||||||||||
| · Level 1 · Level 2 · · Level 3 · Total | ||||||||||||
| Assets: | | | | | | | | | | | | |
| Short-term investments | | $32,358 | | $— | | $— | | $32,358 | ||||
| Total assets measured at fair value | | $32,358 | | $— | | $— | | $32,358 | ||||
| Liabilities: | | | | | ||||||||
| Share-based compensation liability | | $— | | $— | | $422,002 | | $422,002 | ||||
| Warrant liability | | | — | | | — | | | 94,185 | | | 94,185 |
| Total liabilities measured at fair value | | $— | | $— | | $516,187 | | $516,187 | ||||
No transfers between levels have occurred in either reporting period presented. Refer to Note 6 for disclosures related to the warrant liability and Note 8 for disclosures related to share-based compensation liability.
**4.**PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consist of the following:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · December 31, · · December 31, · | |||||||
| · 2024 · 2023 · | |||||||
| Upfront research payments | | $5,087,692 | | $146,851 | | ||
| Accrued interest and other receivables | | 78,034 | | 78,637 | | ||
| Insurance | | 335,976 | | 482,297 | | ||
| Consultants | | — | | 21,535 | | ||
| License fees | | 38,255 | | 30,472 | | ||
| Deferred financing costs | | | — | | | 195,632 | |
| Miscellaneous | | 47,281 | | 33,217 | | ||
| Total prepaid expenses and other current assets | | $5,587,238 | | $988,641 | | ||
**5.**ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accrued liabilities consist of the following:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · December 31, · · December 31, · | |||||||
| · 2024 · 2023 · | |||||||
| Legal | | $44,610 | | $66,254 | | ||
| Deferred financing costs | | | — | | | 99,883 | |
| Accounting | | 95,182 | | 101,528 | | ||
| Research and development | | 223,559 | | 691,908 | | ||
| Severance | | | 38,328 | | | 518,704 | |
| Other | | 79,283 | | 28,249 | | ||
| Accrued liabilities | | $480,962 | | $1,506,526 | | ||
In May 2023, the Company entered into an agreement with a vendor which gave the option to defer payment on approximately $5.4 million of current accounts payable and accrued liabilities until March 31, 2024. The outstanding balance of invoices due to the vendor accrued interest at an annual rate of 5.5%, paid monthly. As of December 31, 2023, the amount outstanding under the agreement recorded in accounts payable was $5.7 million. The Company made a cash payment of approximately $5.9 million to settle the entirety of the amount outstanding under the agreement in March 2024.
| 6. | EQUITY |
The Company has authorized an unlimited number of both Common and Preferred shares. As of December 31, 2024 and 2023, the Company had 32,689,190 and 18,885,254 issued and outstanding Common Shares, respectively, and 0 and 1,166,667 issued and outstanding Series 2 Convertible Preferred Shares, respectively. All share classes haveno par value.
Common Shares reserved for future issuance consists of the following:
| · · · · | |||
|---|---|---|---|
| · · December 31, | |||
| | | 2024 | 2023 |
| Warrants | | 57,141,386 | 13,595,987 |
| Series 2 Convertible Preferred Shares | | — | 1,166,667 |
| Options issued and outstanding under stock option plan | | 3,574,453 | 898,262 |
| Deferred Share Units granted | | 1,061 | 1,061 |
| Common Shares available for grant under stock option plan | | 2,963,385 | 471,843 |
| Total Common Shares reserved for future issuance | | 63,680,285 | 16,133,820 |
Common Shares
The preferences, privileges, and rights of the Common Shares are as follows:
Voting
Subject to any special voting rights or restrictions, holders of common shares entitled to vote shall haveone vote per share.
Dividends
The Company’s board of directors may from time to time declare and authorize payment of dividends, if any, as they may deem advisable and need not give notice of such declaration to any shareholder. Subject to the rights of common shareholders, if any, holding shares with specific rights as to dividends, all dividends on common shares shall be declared and paid according to the number of such shares held and paid in Canadian dollars.
Liquidation Rights
In the event of the liquidation, dissolution or winding-up of the Company or any other distribution of the Company’s assets for the purpose of winding up the Company’s affairs, after the payment of dividends declared but unpaid, the holders of Common Shares shall be entitledpari passu to receive any remaining property of the Company.
Series 2 Convertible Preferred Shares
In November 2023, the directors of the Company authorized the issuance of an unlimited number of Series 2 Convertible Preferred Shares (“Series 2 Shares”). In December 2023, the Company entered into an agreement with holders of the Company’s Series 1 Convertible Preferred Shares (“Series 1 Shares”) to exchange all 70,000,000 outstanding Series 1 Shares for 1,166,667 Series 2 Shares (an equivalent number of as-converted Common Shares) in exchange for the Series 1 Shareholders waiving their rights under a financing limitation side letter entered into amongst the Company and the Series 1 Shareholders during the August 2023 PIPE. Following the Series 2 exchange, the Company was no longer subject to any financing limitations and there were no longer any Series 1 Shares outstanding.
The Series 2 Shares carry the same rights and privileges as the Series 1 Shares, except the mandatory conversion threshold which was increased as described below. The Company treated the exchange for Series 2 Shares as a modification of the Series 1 Shares and determined there was no material difference in fair value between the Series 2 Shares and the Series 1 Shares, and as such no deemed dividend was recognized in the consolidated financial statements as a result of the exchange.
The Series 2 Shares have the following preferences, privileges and rights:
Dividends
If the Company declares, pays or sets aside any dividends on shares of any other class or series of capital stock the holders of the Series 2 Shares shall receive a dividend on each outstanding share of Series 2 Shares in an amount equal to that dividend per share of the Preferred Share as would equal the product of the dividend payable as if all shares of such series had been converted into Common Shares.
Liquidation
In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of the Series 2 Shares shall be entitled to be paid out of the assets of the Company available for distribution to the shareholders an amount per share equal to $6.00, plus any dividends declared but not paid. If, upon any such
liquidation event, the assets available for distribution to the shareholders are insufficient to pay the holders of the Series 2 Shares, the holders of the Series 2 Shares shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.
Voting
The Series 2 Shares do not confer any voting rights or privileges.
Redemption
The Series 2 Shares are not subject to mandatory redemption or other redemption provisions for which the events resulting in redemption are not within the Company’s control.
Optional Conversion
Series 2 Shares are convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, at ratio of 1 Series 2 Share into 1 Common Share.
Mandatory Conversion
All outstanding Series 2 Shares shall automatically convert into Common Shares, at the effective conversion rate upon the closing of one singular financing, including a financing with multiple tranches in which any subsequent tranches are closed within 18 months of the initial closing, which financing results in at least single sale, executable in one or more tranches, of equity securities resulting in at least $14.0 million of cumulative gross proceeds to the Company.
The July 2024 PIPE (defined below) qualified as a mandatory conversion event for the Series 2 Shares, whereby all 1,166,667 outstanding Series 2 Shares converted into 1,166,667 fully paid non-assessable Common Shares upon the closing of the transaction. Following the mandatory conversion event, there were no outstanding Series 2 Shares.
Equity Transactions
Functional Currency Change
Following the change in functional currency effective July 1, 2023, the Company reassessed the classification of its historical US$ and C$ denominated warrants in accordance with the Company’s accounting policy for warrants. As a result of the reassessment, the Company determined that 870,026 US$ warrants to purchase Common Shares, originally issued in financing transactions in 2021 and 2022, previously classified as warrant liabilities met the criteria under ASC 815-40 for permanent equity classification. The fair value of US$ warrants of $1,287,400, calculated using a Black Scholes calculation as of June 30, 2023, was reclassified from warrant liability to additional paid-in-capital in the accompanying consolidated financial statements. The fair value of the US$ warrants represented the entirety of the Company’s warrant liability as of June 30, 2023. The US$ warrants will not be re-measured prospectively.
As result of the reassessment the Company determined that 687,591 C$ warrants, originally issued in financing transactions between 2018 and 2020, which were previously classified in permanent equity no longer met the criteria for equity classification. The C$ warrants were remeasured as of July 1, 2023. The C$ warrants have exercise prices between C$12.00 and C$28.80 and expire between January 2024 and November 2025. The Company measured the fair value of the C$ warrants on July 1, 2023 using a Black Scholes calculation and the resulting fair value of $396,375 was recorded as a reclassification from additional paid-in-capital to warrant liability. The C$ warrant liability was subsequently re-measured at December 31, 2023 to a fair value of $94,185, with the change in fair value of $302,190 reported in other income in the accompanying consolidated statement
of operations and comprehensive income (loss). The C$ warrants liability was re-measured at December 31, 2024 to a fair value of $5,592, with the change in fair value of $88,593 reported in other income in the accompanying consolidated statement of operations and comprehensive income (loss).
The weighted-average values of the significant assumptions used in the Black Scholes valuation of the C$ warrants as of December 31, 2023 included volatility of 131.5%, a risk-free rate of 3.88%, exercise price of C$12.60 and an expected term of 1.8 years. The weighted-average values of the significant assumptions used in the Black Scholes valuation of the C$ warrants as of December 31, 2024 included volatility of 110.2%, a risk-free rate of 2.93%, exercise price of C$12.00 and an expected term of 0.9 years.
July 2024 Private Placement
On July 26, 2024, the Company entered into a Unit Purchase Agreement (the “Unit Purchase Agreement”) to raise $30,332,984 in aggregate gross proceeds for the Company (the “July 2024 PIPE”) before deducting $2,675,487 in placement agent fees and other expenses. All gross proceeds were received by the Company as of December 31, 2024.
Pursuant to the terms of the Unit Purchase Agreement, the Company agreed to sell to PIPE Investors in the Offering, an aggregate of (x)9,757,669 common share units (the “Common Share Units”), each consisting of (i)one Common Share, (ii)one Tranche A Common Share purchase warrant to purchaseone Common Share, (iii)one Tranche B Common Share purchase warrant to purchaseone Common Share and (iv)one Tranche C Common Share purchase warrant to purchaseone Common Share (each, a “Warrant”, collectively, the “Warrants”) and, for certain investors, (y)4,371,027 pre-funded units (the “Pre-Funded Units” and together with the Common Share Units, the “Units”), each consisting of (i)one Pre-Funded Warrant to purchaseone Common Share (each, a “Pre-Funded Warrant”, collectively, the “Pre-Funded Warrants”, and the Common Shares issuable upon exercise of the Warrants and the Pre-Funded Warrants, the “Warrant Shares”), (ii)one Tranche A Common Share purchase warrant to purchaseone Common Share, (iii)one Tranche B Common Share purchase warrant to purchaseone Common Share and (iv)one Tranche C Common Share purchase warrant to purchaseone Common Share.
The purchase price for each Common Share Unit was $2.15 per Common Share Unit, and the purchase price for each Pre-Funded Unit was $2.14 per Pre-Funded Unit. The Pre-Funded Warrants have an exercise price of $0.01 per Warrant Share, are immediately exercisable and will expire when exercised in full. The Tranche A Common Share purchase warrants have an exercise price of $2.02, for aggregate gross proceeds of up to $28.5 million, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i)18 months or (ii) within 60 days of the Tranche A Milestone Event (as defined below). The Tranche B Common Share purchase warrants have an exercise price of $2.02, for aggregate gross proceeds of up to $28.5 million, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i)30 months or (ii) within 60 days of the Tranche B Milestone Event (as defined below). The Tranche C Common Share purchase warrants have an exercise price of $2.50, for aggregate gross proceeds of up to $35.3 million, are immediately exercisable and will expire on July 31, 2029. For purposes of the foregoing, “Tranche A Milestone Event” means the public announcement via press release or the filing of a Current Report on Form 8-K of 6-month data from the cohorts treated with multiple ascending doses of PMN310, and “Tranche B Milestone Event” means the public announcement via press release or the filing of a Current Report on Form 8-K of 12-month data from the cohorts treated with multiple ascending doses of PMN310. Pursuant to Nasdaq Listing Rule 5635(d), the exercise of the Tranche A and Tranche B Common Share purchase warrants is subject to shareholder approval (the “Shareholder Approval”). The Company agreed to convene a shareholders’ meeting, or otherwise obtain written Shareholder Approval, on or before 90 days following the Closing Date, to obtain such approval.
The AB Warrants were classified as liabilities (“AB Warrant Liability”) and recorded at fair value utilizing level 3 inputs at issuance due to the requirement for Shareholder Approval. Under the applicable accounting guidance, the requirement for Shareholder Approval precludes a financial instrument from equity classification, as it cannot be considered indexed to the Company's own stock. The preclusion is because of the potential of the settlement amount differing than a fixed for fixed option on the Company's shares. The fair value of the AB
Warrant Liability at issuance was determined to be $31,182,033, calculated using a Black Scholes calculation on July 26, 2024 with the following weighted average assumptions: share price of $2.02, the most currently available Nasdaq Official Closing Price for the Company’s Common Shares when the Company entered into the purchase agreements, exercise price of $2.02, volatility of 102.5%, risk-free rate of 4.34%, and a term of 2.1 years.
The Company incurred offering costs totaling $2,675,487 that consisted of placement agent fees and direct incremental legal, advisory, accounting and filing fees relating to the July 2024 PIPE, resulting in net cash proceeds of $27,657,497. The value of the AB Warrants exceeded the net proceeds received. As a result, the entire proceeds and offering costs were allocated to the AB Warrant liability, and also resulted in a loss on issuance of common shares, warrants, and pre-funded warrants of $3,524,535, which was recorded in other income (expense) in the consolidated statements of operations and comprehensive income (loss).
On October 23, 2024, Shareholder Approval for the Tranche A and B Warrants was obtained during the Company’s Special Meeting of Shareholders. Following Shareholder Approval, the Company determined that the AB Warrants met the criteria for equity classification. The Company re-measured the fair value of the AB Warrant Liability at October 23, 2024 to $8,689,149, calculated using a Black Scholes calculation with the following weighted average assumptions: volatility of 100.9%, share price of $0.95, exercise price of $2.02, risk-free rate of 4.10%, and a term of 1.9 years. The change in fair value of the AB Warrant Liability of $22,492,884 was recorded in other income (expense) in the consolidated statements of operations and comprehensive income (loss) and the remaining fair value of $8,689,149 was reclassified from liability to additional paid-in-capital in the consolidated balance sheet.
A summary of warrant liability activity, which are based on level 3 inputs, for the years ended December 31, 2024 and 2023 is as follows:
| | | | |
|---|---|---|---|
| | December 31, | ||
| · · 2024 | |||
| Fair value at December 31, 2023 | | $94,185 | |
| July 2024 PIPE AB Warrant Liability at issuance | | 31,182,033 | |
| Change in fair value of 2024 PIPE AB Warrant Liability | | | (22,492,884) |
| Reclassification of 2024 PIPE AB Warrant Liability to equity | | | (8,689,149) |
| Change in fair value of C$ warrant liability | | | (88,593) |
| Fair value at December 31, 2024 | | $5,592 | |
| | | | |
|---|---|---|---|
| · · December 31, | |||
| · · 2023 | |||
| Fair value at December 31, 2022 | | $1,859,374 | |
| Change in fair value of the warrant liability | | (564,548) | |
| Foreign exchange loss | | (7,426) | |
| Fair value of US$ warrant liability as of June 30, 2023 | | | 1,287,400 |
| Fair value of previously liability-classified US$ warrants reclassified to additional paid-in-capital as of July 1, 2023 | | | (1,287,400) |
| Fair value of previously equity-classified C$ warrants reclassified to warrant liability as of July 1, 2023 | | | 396,375 |
| Change in fair value of C$ warrant liability | | | (302,190) |
| Fair value at December 31, 2023 | | $94,185 | |
August 2023 Private Placement
In August 2023, through a private placement (“August 2023 PIPE”), the Company issued 9,945,969 Common Shares, and, in lieu of Common Shares, Pre-Funded Warrants to purchase an aggregate of 954,725 Common Shares, and, in each case, accompanying Common Warrants to purchase an aggregate of up to 10,900,604 additional Common Shares at a unit price of $1.88 per Common Share and accompanying Common Warrant (or
$1.87 per Pre-Funded Warrant and accompanying Common Warrant). The private placement resulted in aggregate gross proceeds of $20,483,758 before $2,738,558 of issuance costs. The Common Warrants are exercisable forfive years commencing six months after the issuance date at a price of $1.75.
The Company determined the Pre-Funded Warrants and Common Warrants both met the permanent equity criteria classification. The Pre-Funded Warrants and Common Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the Common Shares with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of common shares upon exercise. In addition, the Pre-Funded Warrants and Common Warrants do not provide any guarantee of value or return. The Company used a Black Scholes calculation to determine the fair value of the Common Warrants at issuance and allocated a share of the net proceeds based on the relative fair value of the Common Warrants. Net proceeds allocated to the Common Warrants were $7,972,736, with the remaining net proceeds of $9,772,464 allocated to the Common Shares. The aggregate net proceeds of the transaction are recorded in additional paid-in-capital.
The Company also issued 327,020 compensation warrants to purchase Common Shares as compensation to a placement agent as part of the August 2023 PIPE. The compensation warrants have an exercise price of $1.75 and expire in February 2029. The Company used a Black Scholes calculation to determine the fair value of the compensation warrants at the issuance date. The fair value of $466,658 of issuance costs are recorded in additional-paid-in capital, which results in a net zero impact to additional paid-in-capital and issuance costs. Significant assumptions used in the Black Scholes calculation included risk free interest rate of 4.36%; historical volatility of 107.3%; and a 5.5-year expiry.
At-the-Market Offering (ATM)
In September 2023, the Company filed a shelf registration statement with the SEC. In conjunction with the shelf registration, the Company entered into an ATM agreement in January 2024 to offer up to $25.0 million of the Company’s Common Shares. During the year ended December 31, 2024, the Company sold 75,862 Common Shares for net proceeds of $190,274 after deducting sales commissions.
**7.**WARRANTS
As of December 31, 2024, outstanding Common Share warrants and exercise prices related to unit offerings are as follows:
| | | | | |
|---|---|---|---|---|
| Exercise · Number of · | ||||
| Price $ · Warrants · · Expiry date | ||||
| C$12.00 | 279,613 | November 2025 | ||
| US$12.60 | 524,088 | August 2026 | ||
| US$9.60 | 146,744 | August 2026 | ||
| US$7.50 | 345,938 | April 2028 | ||
| US$6.10 | 69,188 | April 2028 | ||
| US$1.75 | 11,227,714 | February 2029 | ||
| US$2.02 | | 14,128,696 | | January 2026 |
| US$2.02 | | 14,128,696 | | January 2027 |
| US$2.50 | | 14,128,696 | | July 2029 |
| US$0.01 | | 2,162,013 | | None |
| | 57,141,386 | | | |
During the years ended December 31, 2024 and 2023,407,978 and 100,073 warrants expired without being exercised.
During the years ended December 31, 2024 and 2023,2,803,738 and 360,000 pre-funded warrants were exercised for an equivalent number of common shares for net proceeds of $28,038 and $3,600, respectively.
**8.**SHARE-BASED COMPENSATION
2015 Stock Option Plan
The Company maintains the 2015 Stock Option Plan (“2015 Option Plan”), originally referred to as the 2007 Option Plan. In June 2015, the 2015 Option Plan was amended from a fixed option plan to a rolling share option plan pursuant to which the Company is authorized to grant options of up to 20% of its issued and outstanding Common Shares. Share options granted vest at various rates and have a term not exceedingten years. As of December 31, 2024 and 2023, the Company had 2,963,385 and 471,843 options, respectively, available for grant under the 2015 Option Plan. Share options under the 2015 Option Plan are granted in either US$ or C$. Upon the change in the Company’s functional currency, effective July 1, 2023, C$ share options previously classified as equity were reclassified as liabilities. All grants following the Company’s change in functional currency are in US$.
Canadian Dollar Share Options
The following table summarizes the activity of the C$ share options under the 2015 Option Plan for the years ended December 31, 2024 and 2023. All amounts are denominated in Canadian dollars, except year and share amounts:
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · · · Weighted · · | |||||||
| · · Weighted · Average · · | |||||||
| · · Average · Remaining · · | |||||||
| · · Number of · Exercise · Contractual · · Aggregate | |||||||
| · · Share · Price Per · Term · · Intrinsic | |||||||
| | | Options | | Share | (years) | | Value |
| Outstanding as of January 1, 2023 | 1,043,025 | | $5.60 | 6.1 | | $1,183,860 | |
| Granted | — | | | | | | |
| Forfeited | (143,230) | | 7.10 | | | | |
| Expired | (1,533) | | 15.76 | | | | |
| Outstanding as of December 31, 2023 | 898,262 | | $7.58 | 6.5 | | $— | |
| Expired | (79,769) | | 9.16 | | | | |
| Outstanding as of December 31, 2024 | 818,493 | | 7.36 | 6.6 | | | — |
| Vested and exercisable as of December 31, 2024 | 768,319 | | $7.59 | 6.6 | | $— | |
The aggregate intrinsic value of options outstanding, exercisable, and vested and exercisable is calculated as the difference between the exercise price of the underlying options, and the fair value of the Company’s Common Shares. There wereno C$ share options granted during the years ended December 31, 2024 or 2023.
Upon the change in the Company’s functional currency effective July 1, 2023 C$ share options previously classified as equity were reclassified as liabilities. The C$ options were re-measured as of December 31, 2024 and had a fair value of $199,263.
A summary of share-based compensation liability activity, measured using level 3 fair value inputs, for the year ended December 31, 2024 is as follows:
| | | | |
|---|---|---|---|
| | December 31, | ||
| · · 2024 | |||
| Fair value at December 31, 2023 | | $422,002 | |
| Increase in additional paid-in-capital due to decrease in fair value of share-based compensation liability | | | (222,739) |
| Fair value at December 31, 2024 | | $199,263 | |
A summary of share-based compensation liability activity for the year ended December 31, 2023 is as follows:
| | | | |
|---|---|---|---|
| | December 31, | ||
| · · 2023 | |||
| Fair value at December 31, 2022 | | $— | |
| Share-based compensation liability of C$ options at reclassification on change in functional currency | | | 1,768,515 |
| Reduction in share-based compensation expense due to decrease in fair value of share-based compensation liability | | | (332,603) |
| Increase in additional paid-in-capital due to decrease in fair value of share-based compensation liability | | | (1,013,910) |
| Fair value at December 31, 2023 | | $422,002 | |
The following table summarizes the weighted average of significant assumptions used to calculate the fair value of C$ share options using the Black Scholes option pricing model:
| · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Period Ended | ||||||||
| · · December 31, · · December 31, · · July 1, · | ||||||||
| · 2024 · 2023 · · 2023 · | ||||||||
| Weighted average fair value of C$ Options · · C$0.26 · · C$1.30 · · C$2.54 · | ||||||||
| Expected volatility | | 99.7% | | 116.3% | | 83.3% | ||
| Risk-free interest rate | | 4.40% | | 4.04% | | 4.30% | ||
| Expected dividend yield | | —% | | —% | | —% | ||
| Expected term (years) | | 6.6 | | 6.5 | | | 6.8 | |
Expected volatility is based on historical volatility of the Company’s Common Shares over the expected life of the option, as the Company’s options are not readily tradable.
U.S. Dollar Share Options
The Company began making share option grants denominated in US$ following the Company’s change in functional currency in July 2023. The following table summarizes the US$ share options outstanding under the
2015 Option Plan for the years ended December 31, 2024 and 2023. All amounts are denominated in US$, except year and share amounts:
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · · · Weighted · · | |||||||
| · · Weighted · Average · · | |||||||
| · · Average · Remaining · · | |||||||
| · · Number of · Exercise · Contractual · · Aggregate | |||||||
| · · Share · Price Per · Term · · Intrinsic | |||||||
| | | Options | | Share | (years) | | Value |
| Outstanding as of January 1, 2023 | — | | $— | | | $— | |
| Granted | 69,000 | | 1.87 | | | | |
| Outstanding as of December 31, 2023 | 69,000 | | $1.87 | | | $— | |
| Granted | 2,686,960 | | 1.11 | | — | ||
| Outstanding as of December 31, 2024 | 2,755,960 | | 1.13 | 9.7 | | | — |
| Vested and exercisable as of December 31, 2024 | 631,607 | | $1.17 | 9.5 | | $— | |
The grant date fair value of 2,196,622 and 69,000 US$ share options granted during the years ended December 31, 2024 and 2023, respectively, was estimated using Black Scholes with the following assumptions:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · Period Ended | |||||
| | | December 31, | | December 31, | |
| | | 2024 | | 2023 | |
| Weighted average fair value of US$ Options | | $0.88 | | $1.53 | |
| Expected volatility | | | 101.7% | | 101.9% |
| Risk-free interest rate | | | 3.95% | | 4.77% |
| Expected dividend yield | | | —% | | —% |
| Expected term (years) | | | 5.7 | | 6.1 |
In October 2024, the Company granted its Chief Executive Officer 490,338 options with an exercise price of $1.15 which will begin vesting if and when the Company’s 10-day VWAP of its Common Shares trading on the Nasdaq Capital Market meets or exceeds $3.45. The Company determined the share price requirement to begin vesting represented a market condition and performed a Monte-Carlo simulation to determine the fair value of the award, discounted for the likelihood of achieving the market condition. The resulting fair value of the option award was $383,000, with $39,344 recognized during the year ended December 31, 2024 in the accompanying consolidated statement of operations and comprehensive income (loss), with the remaining $343,656 expected to be recognized over approximately 2.4 years.
DSU Plan
The Company has a Deferred Share Unit plan (“DSU Plan”) for senior officers. Under the DSU Plan, rights to the Company’s Common Shares may be awarded on a deferred payment basis up to a maximum of 16,666 common share units. Each common share unit will fully vest upon cessation of employment with the Company and then can be redeemed forone common share of the Company by the unitholder. The Company has 1,061 units outstanding as of December 31, 2024.
Share-based Payment Expense
The following table summarizes total share-based compensation for both the C$ and US$ share options included in the Company’s accompanying consolidated statements of operations and comprehensive income (loss):
| · · · · · · | ||||
|---|---|---|---|---|
| · · · · · · | ||||
| · · Year Ended December 31, | ||||
| · · 2024 · 2023 | ||||
| Research and development | | $49,405 | | $80,825 |
| General and administrative | | 776,403 | | 190,717 |
| Total share-based compensation | | $825,808 | | $271,542 |
As of December 31, 2024, there was $30,318 of unrecognized share-based compensation liability related to C$ options outstanding but unvested, which is expected to be recognized over weighted-average remaining service period of 1.0 years. As of December 31, 2024, there was $1,593,563 of unrecognized share-based compensation related to US$ options outstanding, which is expected to be recognized over a weighted-average remaining service period of 2.3 years.
**9.**INCOME TAXES
As of December 31, 2024 and 2023, the net deferred tax assets have not been recognized in the accompanying consolidated financial statements. A valuation allowance is recognized to reduce the deferred tax asset as it is more likely than not that a tax benefit will not be realized.
The following are the significant components of the Company’s deferred taxes as of December 31:
| | | | | | | |
|---|---|---|---|---|---|---|
| · 2024 · 2023 | ||||||
| Non-capital losses carried forward | | $24,850,000 | | $21,151,000 | ||
| Research and development expenditures | | 3,175,000 | | 3,246,000 | ||
| Investment tax credits | | 2,043,000 | | 2,088,000 | ||
| Tax value of technology rights and property and equipment in excess of accounting basis | | 193,000 | | 221,000 | ||
| Share issue costs | | 1,275,000 | | 1,019,000 | ||
| Non-deductible reserves | | | 10,000 | | | — |
| Restricted interest and financing expenses | | 337,000 | | — | ||
| Total deferred income tax assets | | 31,883,000 | | 27,725,000 | ||
| Valuation allowance | | (31,883,000) | | (27,725,000) | ||
| Net deferred income tax assets | | $— | | $— | ||
As of December 31, 2024, the Company has available research and development expenditure credits for income tax purposes of approximately $11,980,000, which may be carried forward without expiration to reduce future taxable income.
As of December 31, 2024, the Company has non-capital income tax loss carry-forwards of approximately $93,772,000 available to reduce future income for income tax purposes. The income tax loss carry-forwards have expiry dates between the years 2026 and 2043.
As of December 31, 2024, the Company has approximately $2,043,000 of non-refundable investment tax credits available to offset future income taxes. The non-refundable investment tax credits have expiry dates between 2025 and 2035.
A reconciliation of the combined federal and provincial statutory income tax rate applied to the net loss for the year to the income tax recovery as of December 31 is as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · 2024 · 2023 | |||||||
| Basic combined Canadian statutory income tax rate | | 26.5% | | 26.5% | |||
| Income tax recovery based on statutory rate | | $719,000 | | $(3,559,000) | | ||
| Permanent differences | | (4,808,000) | | (157,000) | | ||
| Share issue costs recorded, net of equity | | (709,000) | | (731,000) | | ||
| Unrecognized benefit of current year tax losses | | 4,798,000 | | 4,447,000 | | ||
| | | $— | | $— | | ||
The Company does not expect a significant change in the amount of unrecognized tax benefits over the next 12 months. However, any adjustments arising from certain ongoing examinations by tax authorities could alter the timing or amount of taxable income or deductions and these adjustments could differ from the amount accrued. The Company’s federal and provincial income tax returns files for all years remain subject to examination by the taxation authorities.
**10.**Segment Reporting
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources in assessing performance. The Company hasone reportable segment: life science. The life science segment consists of the development of clinical and preclinical product candidates. The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
The accounting policies of the life science segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the life science segment based on net income (loss), which is reported on the income statement as consolidated net income (loss). The measure of segment assets is reported on the balance sheet as total consolidated assets.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.
As such, the CODM uses cash forecast models in deciding how to invest into the life science segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net income (loss) is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment and in establishing management’s compensation, along with cash forecast models.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2024, and 2023:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Years Ended December 31, | ||||||
| | | 2024 | 2023 | |||
| Operating Expenses: | | | | | | |
| PMN310 development program costs | | $8,275,268 | | $4,776,411 | ||
| Other non-employee research and development costs | | 772,501 | | 1,602,164 | ||
| Employee costs | | | 3,336,580 | | | 3,102,238 |
| Other general and administrative costs | | | 4,443,129 | | | 4,781,920 |
| Net Operating Loss: | | $16,827,478 | | $14,262,733 | ||
| Other segment items(a) | | | (19,606,351) | | | (1,050,251) |
| Net (Income) Loss: | | $(2,778,873) | | $13,212,482 | ||
| | | | | | | |
| Reconciliation of profit or loss | | | | | | |
| Adjustments and reconciling items | | | — | | | — |
| Consolidated net (income) loss: | | $(2,778,873) | | $13,212,482 | ||
| | | | | | | |
| (a)Other segment items included in segment (income) loss include changes in warrant liability, interest income, and interest expense, and in 2024 Loss on issuance of common shares, warrants, and pre-funded warrants in July 2024 PIPE | ||||||
**11.**RELATED PARTY TRANSACTIONS
UBC Collaborative Research Agreement
In April 2016, the Company entered into a collaborative research agreement (“CRA”) with the University of British Columbia (“UBC”) and the Vancouver Coastal Health Authority in the amount of C$787,500, with the Company’s Chief Scientific Officer, as principal investigator at the UBC. In January 2022, the UBC CRA was amended to extend the project for an additional three years, and in December 2024, for an additional 1 year. Aggregate funding under the agreement was increased to a total of C$5,830,000 through February 2026. During the years ended December 31, 2024 and 2023, the Company made cash payments of $587,000 and $588,136, respectively, and incurred costs of $584,226 and $592,810, respectively, which are included in research and development expenses in the accompanying consolidated statements of operations and comprehensive income (loss).
Neil Warma Employment Agreement
In October 2024, in connection with Mr. Neil Warma’s appointment to the role of CEO, he entered into an employment agreement with the Company (the “CEO Employment Agreement”) providing for an annual base salary of $500,000 and annual discretionary bonus with a target of 50% of his base salary. Mr. Warma was also provided (i) severance in the amount of 12-months’ salary, a pro-rated annual bonus at target, acceleration of time-based stock options and standard continuing benefits in connection with a termination without cause and (ii) severance in the amount of the sum of 18-months’ salary and a pro-rated annual bonus at target, acceleration of time-based stock options and standard continuing benefits in connection with a change in control of the Company.
In connection with his appointment, Mr. Warma was also granted (i) an option to purchase 1,144,122 of the Company’s common shares (the “Initial Award”) and (ii) an option to purchase 490,338 of the Company’s common shares (the “Performance Award”). Per the Company’s 2015 Stock Option Plan, the exercise price of each of the Initial Award and the Performance Award is $1.15 per share, the 5-day volume-weighted average price (“VWAP”) as of October 8, 2024. The Initial Award is 25% vested upon grant with the remaining shares vesting ratably over thirty-six months. The Performance Award shall vest 25% on the date that the 10-day VWAP of the Company’s common shares on the Nasdaq Capital Market exceeds three times the exercise price, with the remainder vesting ratably over the following thirty-six months. Refer to Note 8, Share-Based Compensation, for further discussion on the Performance Award.
**12.**COMMITMENTS AND CONTINGENCIES
Research, Development and License Agreements
The Company enters into research, development and license agreements with various parties in the ordinary course of business where the Company receives research services and rights to proprietary technologies. The agreements require compensation to be paid by the Company, typically, by a combination of the following:
| ● | fees comprising amounts due initially on entering into the agreements and additional amounts due either on specified timelines or defined services to be provided; |
| ● | milestone payments that are dependent on products developed under the agreements proceeding toward specified plans of clinical trials and commercial development; and |
| ● | royalty payments calculated as a percentage of net sales, commencing on commercial sale of any product candidates developed from the technologies. |
Milestone and royalty related amounts that may come due under various agreements are dependent on, among other factors, preclinical safety and efficacy, clinical trials, regulatory approvals and, ultimately, the successful development and commercial launch of a new drug, the outcomes and timings of which are uncertain. Amounts due per the various agreements for milestone payments will accrue once the occurrence of a milestone is likely. Amounts due as royalty payments will accrue as commercial revenues from the product are earned. Through December 31, 2024, no events have occurred that require accrual of any milestone or royalty related amounts.
UBC and the Vancouver Coastal Health Authority Agreement
In April 2016, the Company entered into athree-year, CRA with the UBC and the Vancouver Coastal Health Authority. The agreement was amended various times through November 2021. Refer to Note 11 Related Party Transactions.
UBC Agreement
In February 2009, the Company entered into an agreement with UBC to further the development and commercialization of certain technology developed, in part, by the Company’s Chief Scientific Officer. The agreement was amended and restated in October 2015. Under the amended and restated agreement, the Company is committed to make royalty payments based on revenue earned from the licensed technology. An annual license fee is payable over the term of the agreement. The agreement remains effective unless terminated under the provisions of the agreement. The Company made annual license payments of C$25,000 during each of the years ended December 31, 2024 and 2023. Through December 31, 2024 no accruals for royalty payments have been made.
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers
against liabilities that may arise by reason of their status or service as directors or officers. The Company currently has directors’ and officers’ insurance.
| 13. | NET LOSS PER SHARE |
Basic net earnings per share applicable to common stockholders is calculated by dividing net earnings applicable to common shareholders by the weighted average shares outstanding during the period, without consideration for common share equivalents. Diluted net earnings per share applicable to common shareholders is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common share equivalents outstanding for the period, determined using the treasury-stock method and the if-converted method. For purposes of the calculation of dilutive net income (loss) per share applicable to common shareholders, stock options, and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net income (loss) per share applicable to common shareholders when their effect would be anti-dilutive or would not add additional Common Shares to the denominator of the calculation due to being out-of-the-money.
As of December 31, 2024 and 2023, respectively,2,162,013 and 594,725 Pre-Funded Warrants to purchase common shares for little to no consideration, issued in connection with the August 2023 Private Placement and July 2024 Private Placement (see Note 6), were included in the basic and diluted net income (loss) per share calculation. The following table sets forth the computation of basic and diluted net income (loss) per share attributable to common shareholders:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Years Ended December 31, | ||||||
| | | 2024 | 2023 | |||
| Numerator: | | | | | | |
| Net income (loss) | | $2,778,873 | | $(13,212,482) | ||
| Denominator: | | | ||||
| Basic weighted-average common shares outstanding | | 25,919,965 | | 12,292,707 | ||
| Effect of potentially dilutive securities: | | | | | | |
| Warrants | | | 522,053 | | | — |
| Stock options | | | 19,713 | | | — |
| Diluted weighted-average common shares outstanding | | | 26,461,731 | | | 12,292,707 |
| | | | | | | |
| Basic net income (loss) per share attributable to common shareholders | | $0.11 | | $(1.07) | ||
| Diluted net income (loss) per share attributable to common shareholders | | $0.11 | | $(1.07) | ||
The following outstanding potentially dilutive common shares equivalents were excluded from the computation of diluted net income (loss) per share for the periods presented because including them would have been antidilutive:
| | | | | |
|---|---|---|---|---|
| · · Year Ended | ||||
| · · December 31, | ||||
| · 2024 · 2023 | ||||
| Options issued and outstanding under stock option plan | 3,574,453 | 967,262 | ||
| Warrants | 54,979,373 | 13,001,262 | ||
| Series 2 Convertible Preferred Shares | | — | | 1,166,667 |
| Deferred Share Units | 1,061 | 1,061 | ||
| Total | 58,554,887 | 15,136,252 | ||
**14.**SUBSEQUENT EVENTS
No subsequent events were identified as of the issuance date of the consolidated financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.