Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 25, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-32295 | ||
Entity Registrant Name | FENNEC PHARMACEUTICALS INC. | ||
Entity Incorporation, State or Country Code | CA | ||
Entity Tax Identification Number | 20-0442384 | ||
Entity Address, Address Line One | PO Box 13628, 68 TW Alexander Drive | ||
Entity Address, City or Town | Research Triangle Park | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27709 | ||
City Area Code | 919 | ||
Local Phone Number | 636-4530 | ||
Title of 12(b) Security | Common Shares, no par value | ||
Trading Symbol | FENC | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 27,099,908 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001211583 | ||
Amendment Flag | false | ||
Document Financial Statement Error Correction [Flag] | true | ||
Document Financial Statement Restatement Recovery Analysis [Flag] | false | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 137,895,876 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | HASKELL & WHITE LLP | ||
Auditor Firm ID | 200 | ||
Auditor Location | Irvine, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 13,269 | $ 23,774 |
Accounts receivable, net | 8,814 | 1,545 |
Prepaid expenses | 2,575 | 770 |
Inventory | 2,156 | 576 |
Other current assets | 44 | 63 |
Total current assets | 26,858 | 26,728 |
Non-current assets | ||
Deferred issuance cost | 816 | 809 |
Deferred issuance cost (amortization) | (810) | (598) |
Total non-current assets | 6 | 211 |
Total assets | 26,864 | 26,939 |
Current liabilities: | ||
Accounts payable | 3,778 | 2,390 |
Accrued liabilities | 3,754 | 2,219 |
Operating lease liability - current | 21 | |
Total current liabilities | 7,553 | 4,609 |
Long term liabilities | ||
Term loan | 30,000 | 25,000 |
PIK interest | 1,219 | 260 |
Debt discount | (288) | (361) |
Operating lease liability - net of current portion | 2 | |
Total long term liabilities | 30,933 | 24,899 |
Total liabilities | 38,486 | 29,508 |
Stockholders' deficit: | ||
Common stock, no par value; unlimited shares authorized; 27,027 shares issued and outstanding (2022 26,361) | 144,307 | 142,591 |
Additional paid-in capital | 62,073 | 56,797 |
Accumulated deficit | (219,245) | (203,200) |
Accumulated other comprehensive income | 1,243 | 1,243 |
Total stockholders' deficit | (11,622) | (2,569) |
Total liabilities and stockholders' deficit | $ 26,864 | $ 26,939 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Common stock, no par value | $ 0 | $ 0 |
Common stock, shares issued | 27,027 | 26,361 |
Common stock, shares outstanding | 27,027 | 26,361 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Consolidated Statements of Operations | ||
PEDMARK, product sales, net | $ 21,252 | $ 1,535 |
Cost of products sold | (1,259) | (86) |
Gross profit | 19,993 | 1,449 |
Operating expenses: | ||
Research and development | 56 | 3,531 |
Selling and marketing | 12,123 | 2,785 |
General and administrative | 20,585 | 17,722 |
Total operating expenses | 32,764 | 24,038 |
Loss from operations | (12,771) | (22,589) |
Other (expense)/income | ||
Unrealized foreign exchange gain/(loss) | 5 | (9) |
Amortization expense | (287) | (149) |
Unrealized loss on securities | (39) | (184) |
Interest income | 441 | 195 |
Interest expense | (3,394) | (978) |
Total other expense | (3,274) | (1,125) |
Net loss | $ (16,045) | $ (23,714) |
Basic net loss per common share | $ (0.60) | $ (0.90) |
Diluted net loss per common share | $ (0.60) | $ (0.90) |
Weighted-average number of common shares outstanding basic | 26,574 | 26,275 |
Weighted-average number of common shares outstanding diluted | 26,574 | 26,275 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-in Capital Employees | Additional Paid-in Capital Consultants | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Employees | Consultants | Total |
Balance at Dec. 31, 2021 | $ 140,801 | $ 53,214 | $ (179,486) | $ 1,243 | $ 15,772 | ||||
Balance (in shares) at Dec. 31, 2021 | 26,014 | ||||||||
Stock options issued | $ 4,087 | $ 133 | $ 4,087 | $ 133 | |||||
Exercise of stock options | $ 1,790 | (216) | 1,574 | ||||||
Exercise of stock options (in shares) | 273 | ||||||||
Restricted stock release (in shares) | 74 | ||||||||
Warrants issued in connection with term loan | 441 | 441 | |||||||
Issuance of securities | (862) | (862) | |||||||
Net loss | (23,714) | (23,714) | |||||||
Balance at Dec. 31, 2022 | $ 142,591 | 56,797 | (203,200) | 1,243 | (2,569) | ||||
Balance (in shares) at Dec. 31, 2022 | 26,361 | ||||||||
Net loss | (12,413) | ||||||||
Balance at Sep. 30, 2023 | (215,613) | 9,581 | |||||||
Balance at Dec. 31, 2022 | $ 142,591 | 56,797 | (203,200) | 1,243 | (2,569) | ||||
Balance (in shares) at Dec. 31, 2022 | 26,361 | ||||||||
Stock options issued | $ 5,354 | $ 5,354 | |||||||
Exercise of stock options | $ 1,716 | 1,716 | |||||||
Exercise of stock options (in shares) | 588 | ||||||||
Restricted stock release | (78) | (78) | |||||||
Restricted stock release (in shares) | 78 | ||||||||
Net loss | (16,045) | (16,045) | |||||||
Balance at Dec. 31, 2023 | $ 144,307 | $ 62,073 | $ (219,245) | $ 1,243 | $ (11,622) | ||||
Balance (in shares) at Dec. 31, 2023 | 27,027 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||
Net loss | $ 16,045 | $ 23,714 |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of debt access fees | 221 | 132 |
Amortization of debt discount | 66 | 17 |
Unrealized loss/(gain) on securities | 39 | 184 |
Stock-based compensation - consultants | 133 | |
Stock-based compensation - employees | 5,354 | 4,087 |
Changes in operating assets and liabilities: | ||
Accounts receivables | (7,269) | (1,545) |
Prepaid expenses | 104 | 264 |
Inventory | (1,580) | (576) |
Other assets | 3 | 6 |
Accounts payable | 1,388 | 1,612 |
Accrued liabilities | 576 | 1,342 |
Net cash used in operating activities | (17,143) | (18,058) |
Financing activities: | ||
Issuance of shares, options exercise | 1,716 | 928 |
Proceeds from long-term debt | 4,997 | 24,935 |
Long-term debt paid | (5,000) | |
Debt discount | 3 | 238 |
Cash paid for taxes on restricted share release | (78) | (194) |
Capitalized deferred issuance costs | (175) | |
Net cash provided by financing activities | 6,638 | 20,732 |
Increase/(decrease) in cash and cash equivalents | (10,505) | 2,674 |
Cash and cash equivalents - Beginning of year | 23,774 | 21,100 |
Cash and cash equivalents - End of year | 13,269 | 23,774 |
Non-cash investing and financing activities: | ||
Financed insurance policy | $ 403 | 550 |
Warrants issued in connection with term loan | $ 441 |
Nature of Business and Liquidit
Nature of Business and Liquidity | 12 Months Ended |
Dec. 31, 2023 | |
Nature of Business and Liquidity | |
Nature of Business and Liquidity | 1. Nature of Business and Liquidity Fennec Pharmaceuticals Inc. (“Fennec,” “the Company,” “we,” “us,” or “our”) was originally formed as a British Columbia corporation under the name Adherex Technologies Inc. and subsequently changed its name on September 3, 2014. Fennec, together with its wholly owned subsidiaries Oxiquant, Inc. (“Oxiquant”) and Fennec Pharmaceuticals, Inc., both Delaware corporations, and Cadherin Biomedical Inc. (“CBI”), a Canadian corporation and Fennec Pharmaceuticals (EU) Limited (“Fennec Limited”), collectively referred to herein as the “Company,” is a biopharmaceutical company with one FDA approved product developed to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. With the exception of Fennec Pharmaceuticals, Inc., and Fennec Pharmaceuticals (EU) Limited, all subsidiaries are inactive. These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) that are applicable to a going concern which contemplates that the Company will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities in the normal course of business. During the year ended December 31, 2023, the Company incurred a net loss from operations of $16,045. At December 31, 2023, it had an accumulated deficit of $219,245 and had experienced negative cash flows from operating activities in the amount of $17,143 for the year ended December 31, 2023. On August 1, 2022, the Company entered into a Securities Purchase Agreement (the “SPA”) with Petrichor Opportunities Fund I LP (the “Investor”) in connection with the issuance of up to $45,000 of senior secured floating rate convertible notes (the “Notes”), issuable in multiple tranches (the “Note Financing”). On August 19, 2022, the Company closed on the initial tranche of $5,000 (the “First Closing Note”) which has an Initial Conversion Price equal to $8.11 per share, which was calculated based on a 20% premium of the 5-day volume weighted average price of the Company’s common shares as traded on the Nasdaq Capital Market (the “VWAP”) immediately prior to the announcement of the Securities Purchase Agreement (“SPA”) dated August 1, 2022. In connection with the first closing, the Company repaid in full its secured indebtedness with Bridge Bank in the amount of $5,000. On September 23, 2022, the Company closed on the second tranche of the Note Financing in the amount of $20,000 (the “Second Closing Note”), which has an Initial Conversion Price equal to $7.89 per share, which was calculated based on a 20% premium of the 5-day VWAP immediately prior to September 20, 2022, which was the date the Company obtained FDA approval of PEDMARK ® A commitment fee of 2.0% of the Notes was payable under the SPA. Half half five On December 4, 2023, the Company closed a third tranche under the SPA in the amount of $5,000,000 (the “Third Closing Note”), which has an Initial Conversion Price equal to $7.89 per share, which was calculated based on a 20% premium of the 5-day VWAP immediately prior to September 20, 2022, which was the date the Company obtained FDA approval of PEDMARK ® Also on December 4, 2023, the Company entered into a First Amendment to the Securities Purchase Agreement (the “SPA Amendment”) with the Investor, which, among other things, extends the period that the Company may draw the remaining $15,000,000 under the SPA from December 31, 2023, to December 31, 2024. Subsequent draws are subject to mutual agreement of the Company and the Investor and will be represented by Notes that will also be convertible at a price equal to $7.89 per share. The Company believes current funds, which include funds from the First, Second and Third Closing Notes, provide sufficient funding for the Company to carry out its planned activities, including the continuation of commercialization efforts for at least the next twelve months of PEDMARK ® These financial statements do not reflect the potentially material adjustments in the carrying values of assets and liabilities, the reported expenses, and the balance sheet classifications used, that would be necessary if the going concern assumption were not appropriate. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation The consolidated financial statements include the accounts of Fennec and of all its wholly-owned subsidiaries. All inter-company transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that impact the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of revenue and expense during the reporting period. Significant estimates include revenue recognition, amount and timing of marketing and other services performed by certain distributors, allowance against trade receivables, measurement of stock-based compensation over the next twelve months from the date of issuance of the consolidated financial statements. Actual results could differ from those estimates. Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. As of December 31, 2023, the Company had an operating lease in Ireland. This is the only asset located outside of the United States. Stock-Based Compensation Under The Inventory Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories mainly include third party manufacturing, logistics and distribution costs. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. The manufacturing costs for PEDMARK ® ® Revenue Recognition Under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Net Product Revenue On September 20, 2022, the FDA approved PEDMARK ® ® ® Product Sales Discounts and Allowances The Company records U.S. based revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns and other allowances that are offered within contracts between the Company and its Customers, health care providers, payors and other indirect customers relating to the sales of its products. These reserves are based on the amounts to be claimed on the related sales and are classified as a contra-asset or a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted Customer buying and payment patterns, and the Company’s historical experience that will develop over time as PEDMARK ® The Company also utilizes select distributors to introduce its product into global markets. These distributors take on the function of shipping, storage, marketing and other services related to the sale of our product. We record distribution and other fees paid to these distributors as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received. If both conditions are met, we record the consideration paid to the distributor as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale. Chargebacks: Discounts for Prompt Payment: Rebates: ® Co-payment Assistance: Other Customer Credits: Distribution and Other Fees: We pay distribution and other fees to certain customers in connection with the sales of our products. We record distribution and other fees paid to our customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received. If both conditions are met, we record the consideration paid to the customer as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale. The following table summarizes net product revenues for PEDMARK ® Year Ended December 31, December 31, 2023 2022 Product revenues: Gross product revenues $ 23,782 $ 1,769 Discounts and allowances (2,530) (234) Net product revenues $ 21,252 $ 1,535 For the years ended December 31, 2023 and 2022, the Company had 4 distributors and 3 distributors that represented more than 10% of net sales, respectively. The activities and ending allowance balances for each significant category of discounts and allowances for PEDMARK ® Chargebacks, Rebates, Customer Discounts for Fees/Credits Prompt Pay and and Co-Pay In thousands Other Allowances Assistance Totals Balance at December 31, 2021 $ — $ — $ — Provision related to sales made in: Current period 72 163 235 Prior periods — — — Payments and customer credits issued (1) — (1) Balance at December 31, 2022 $ 71 $ 163 $ 234 Provision related to sales made in: Current period 1,164 600 1,764 Prior periods — — — Payments and customer credits issued (870) (333) (1,203) Balance at December 31, 2023 $ 365 $ 430 $ 795 The allowances for chargebacks, fees due to Customers, rebates and discounts for prompt payment are recorded as a contra-asset to accounts receivable, while Medicaid rebates and return allowances are in accrued liabilities in the accompanying Consolidated Balance Sheets. Trade Receivables The Company records gross trade Cost of Products Sold Cost of products sold is related to the Company's product revenues for PEDMARK ® ® ® ® capitalized, $1.4 million was capitalized as work in process and raw materials, $0.8 million was capitalized into finished goods. Cash and Cash Equivalents Cash equivalents consist of highly liquid investments with original maturities at the date of purchase of three months or less. The Company places its cash and cash equivalents in investments held by highly rated financial institutions in accordance with its investment policy designed to protect the principal investment. As of December 31, 2023, the Company had $13.3 million in cash and money market accounts (2022- $23.8 million). Money market investments typically have minimal risks. While the Company has not experienced any loss or write-down of its money market investments, the amounts it holds in money market accounts are substantially above the $250,000 amount insured by the FDIC and may lose value. Financial Instruments Financial instruments recognized on the balance sheets at December 31, 2023 and 2022, consist of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities and term loans, the carrying values of which approximate fair value due to their relatively short time to maturity or interest rates that approximate market interest rates. The Company does not hold or issue financial instruments for trading. The Company’s investment policy is to manage investments to achieve, in the order of importance, the financial objectives of preservation of principal, liquidity and return on investment. Investments, when made, are made in U.S. or Canadian bank securities, commercial paper of U.S. or Canadian industrial companies, utilities, financial institutions and consumer loan companies, and securities of foreign banks provided the obligations are guaranteed or carry ratings appropriate to the policy. Securities must have a minimum Dun & Bradstreet rating of A for bonds or R1 low for commercial paper. The policy risks are primarily the opportunity cost of the conservative nature of the allowable investments. The Company has chosen to avoid investments of a trading or speculative nature to preserve cash. Common Shares and Warrants The Company has 0.2 million warrants with a weighted average strike price of $7.71 outstanding to purchase common shares that have a weighted average life of 4.05 years. Research and Development Costs and Investment Tax Credits Research costs, including employee compensation, laboratory fees, lab supplies, and research and testing performed under contract by third parties, are expensed as incurred. Development costs, including drug substance costs, clinical study expenses and regulatory expenses are expensed as incurred. Investment tax credits, which are earned as a result of qualifying research and development expenditures, are recognized when the expenditures are made and their realization is reasonably assured. They are applied to reduce related capital costs and research and development expenses in the year recognized. Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, and instrument. The Company’s trade receivables includes amounts billed to Customers, both specialty and select global distributors, for product sales of PEDMARK ® Income Taxes The Company accounts for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates. The Company has deferred tax assets, which are subject to periodic recoverability assessments. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. As of December 31, 2023, and 2022, we maintained a full valuation allowance against our deferred tax assets. The provisions of the Financial Accounting Standards Board (“FASB”) ASC 740-10, Uncertainty in Income Taxes, address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, we may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. Foreign Currency Translation The U.S. dollar is the functional currency for the Company’s consolidated operations. All gains and losses from currency translations are included in results of operations. Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the year. Diluted net loss per share is computed using the same method, except the weighted average number of common shares outstanding includes convertible debentures, restricted share units, stock options and warrants, if dilutive, as determined using the if-converted method and treasury methods. Accordingly, warrants to purchase 0.2 million of our common shares, restricted share units of 0.2 million to obtain our common shares, and options to purchase 4.8 million of our common shares at December 31, 2023, were not included in loss per share. Such options would have an antidilutive effect. In 2022, warrants to purchase 0.2 million of our common shares, restricted share units to obtain 0.04 million of our common shares and options to purchase 4.5 million common shares were excluded from the computation of loss per share as their inclusion would have been antidilutive. Recent Accounting Pronouncements In August 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40). The new standard eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity's own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity's own equity. This ASU will be effective for the year ended December 31, 2024. The Company adopted this ASU in Q1 of 2023. In June 2022, the FASB issued Accounting Standards Update ("ASU") 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, which (1) clarifies the guidance in Topic 820 on the fair value measurement of an equity security that is subject to contractual restrictions that prohibit the sale of an equity security and (2) requires specific disclosures related to such an equity security. This ASU will be effective for the year ended December 31, 2024. The Company adopted this ASU in 2023. In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments – Credit Losses (Topic 326) and subsequently related amendments (ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2019-10, ASU 2019-11 and ASU 2022-02). This guidance replaces the existing incurred loss impairment guidance and establishes a single allowance framework for financial assets carried at amortized cost based on expected credit losses. The estimate of expected credit losses requires the incorporation of historical information, current conditions, and reasonable and supportable forecasts. This ASU will be effective for the year ended December 31, 2023. The Company is currently evaluating the effect the adoption of this ASU will have on the consolidated financial statements. In December 2023 , , |
Loss per Share
Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Loss per Share | |
Loss per Share | 3. Loss per Share Loss per common share is presented under two formats: basic loss per common share and diluted loss per common share. Basic loss per common share is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding during the period. Diluted loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period, plus the potentially dilutive impact of common shares equivalents (e.g. stock options and warrants). Dilutive common share equivalents consist of the incremental common shares issuable upon exercise of stock options and warrants. The following table sets forth the computation of basic and diluted net loss per share (in thousands except per share data): Year Ended December 31, 2023 2022 Numerator: Net loss $ (16,045) $ (23,714) Denominator: Weighted-average common shares, basic 26,574 26,275 Dilutive effect of stock options — — Dilutive effect of warrants — — Dilutive effect of restricted share units — — Incremental dilutive shares — — Weighted-average common shares, diluted 26,574 26,275 Net loss per share, basic and diluted $ (0.60) $ (0.90) The following outstanding options, restricted share units, and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect (in thousands): Year Ended December 31, 2023 2022 Options to purchase common shares 4,798 4,539 Restricted share units to obtain common shares 218 35 Warrants to purchase common shares 150 150 |
Stock options
Stock options | 12 Months Ended |
Dec. 31, 2023 | |
Stock options | |
Stock options | 4. Stock Options The Compensation Committee of the Board of Directors administers the Company’s 2020 Equity Incentive Plan (The “Plan”). The Compensation Committee designates eligible participants to be included under the plan and approves the number of options to be granted from time to time under the plan. On June 24, 2010, at the Company’s annual meeting, shareholders approved an amendment to the Company’s Stock Option Plan (the “Plan Maximum Amendment”). The Plan Maximum Amendment relates to changing the maximum number of common shares issuable under the stock option plan from a fixed number of 6.7 million to the number of shares that represents twenty-five percent (25%) of the total number of all issued and outstanding common shares. Based upon the current shares outstanding, a maximum of 6.8 million of our common shares are authorized for issuance under the plan. The option exercise price for all options issued under the plan is based on the fair value of the underlying shares on the date of grant. All options vest within three ten Summary of $USD Option Activity Number of Options Weighted (in thousands) Range Average Outstanding and exercisable at December 31, 2021 4,259 $ 0.45 – 12.59 $ 5.13 Granted 1,015 5.59 - 8.10 6.50 Exercised (273) 0.45 - 8.38 3.29 Forfeited (462) 5.59 - 8.10 6.79 Outstanding and exercisable at December 31, 2022 4,539 $ 0.45 – 12.59 $ 5.43 Granted 1,245 7.35 - 9.05 8.25 Exercised (586) 0.72 - 7.99 3.18 Forfeited (400) 4.08 - 8.32 7.45 Outstanding and exercisable at December 31, 2023 4,798 $ 4.08 - 10.96 $ 6.27 Summary of $USD Option Remaining Life Number Outstanding and Exercisable at Weighted Average Strike Price Weighted Average December 31, 2023 December 31, 2023 Remaining Life (in thousands) US Dollars (years) 4,798 $6.27 5.58 Stock compensation expense for the fiscal years ended December 31, 2023, and 2022 was $5.4 million and $4.2 million, respectively. These amounts have been included in general and administrative expenses for the respective periods. The weighted average fair value per share of options granted and or vested during the fiscal years ended December 31, 2023, and 2022 was $4.73 and $5.43, respectively. The intrinsic value (being the difference between the share price at December 31, 2023 and exercise price) of stock options exercisable at December 31, 2023 was $23.8 million. The intrinsic value of options exercised during the fiscal year ended December 31, 2023, was $2.97 million. The fair value of all options vested during the fiscal year ended December 31, 2023, was $6.4 million. The fair values of options granted in fiscal years ended December 31, 2023 and 2022 were estimated on the date the options were granted based on the Black-Scholes option-pricing model, using the following weighted average assumptions for all options with a ten-year expiration: Year Ended December 31, 2023 Year Ended December 31, 2022 Expected dividend - % - % Risk-free interest rate 3.58 - 5.31 % 1.18 - 3.96 % Expected volatility 59 - 167 % 150 - 181 % Expected life 1.50 - 6 years 5 - 6 years The Company uses the historical volatility and adjusts for available relevant market information pertaining to the Company’s share price. Restricted Share Units Activity The Plan allows for the issuance of restricted share units (“RSUs”). The following is a summary of RSU activity for the years ended December 31, 2023, and 2022. Prior to June 2021, there was no activity involving RSUs. During the year ended December 31, 2023, 365 RSUs were awarded, 96 were forfeited and 86 were released from restriction. The Company recognized $1.3 million in RSU expense for the year ended December 31, 2023, and $0.3 million for the same period in 2022. Standard vesting of RSUs is over three years with 1/3 1/24 Number of Restricted US Denominated RSU's Share Units (thousands) Outstanding at December 31, 2021 219 Awarded — Forfeited (86) Released (98) Outstanding at December 31, 2022 35 Awarded 365 Forfeited (96) Released (86) Outstanding at December 31, 2023 218 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements The Company has adopted ASC 820 Fair Value Measurements and Disclosure Topic of the FASB. This Topic applies to certain assets and liabilities that are being measured and reported on a fair value basis. The Fair Value Measurements Topic defines fair value, establishes a framework for measuring fair value in accordance with US GAAP, and expands disclosure about fair value measurements. This Topic enables the reader of the financial statements to assess the inputs used to develop those measurements by establishing a hierarchy for ranking the quality and reliability of the information used to determine fair values. The Topic requires that financial assets and liabilities carried at fair value be classified and disclosed in one of the following three categories: Level 1: Quoted market prices in active markets for identical assets or liabilities. Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data. Level 3: Unobservable inputs that are not corroborated by market data. Financial As Assets/Liabilities Measured at Fair Value on a Recurring Basis Fair Value Measurement at December 31, 2023 and December 31, 2022 (in thousands) Quoted Price in Active Market for Identical Significant Other Significant Instruments Observable Inputs Unobservable Inputs Level 1 Level 2 Level 3 Total 2023 2022 2023 2022 2023 2022 2023 2022 Assets Cash and cash equivalents $ 1,340 (1) 307 (1) 11,929 23,467 — — 13,269 23,774 Processa common shares 17 (2) 56 — — — — 17 56 (1) The Company held approximately, $1,340 in cash as of December 31, 2023, of which approximately $473 was in Canadian funds and $97 in Euro (both translated into U.S. dollars). As of December 31, 2022, the Company held approximately $ 307 , of which approximately $33 was in Canadian funds (translated into U.S. dollars). (2) The Company has 41 unrestricted common shares of Processa (PSCA). |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders’ Equity Authorized Capital Stock The Company’s authorized capital stock consists of an unlimited number of shares of no-par common shares. Warrants to Purchase Common Shares At December 31, 2023, the Company had 150 warrants outstanding to purchase common shares at a weighted average exercise price of $7.71. The following table summarized our warrant activity for the fiscal years ended December 31, 2023 and 2022. Number of Warrants Weighted (in thousands) Range Average Outstanding and exercisable at December 31, 2021 $ 39 $ 6.80 $ 6.80 Granted 111 8.11 8 Outstanding and exercisable at December 31, 2022 $ 150 $ 7.71 $ 7.71 Granted — — — Outstanding and exercisable at December 31, 2023 $ 150 $ 7.71 $ 7.71 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 7. Commitments and Contingencies Oregon Health & Science University (“OHSU”) Agreement On February 20, 2013, Fennec entered into a new exclusive license agreement with OHSU for exclusive worldwide license rights to intellectual property directed to thiol-based compounds, including PEDMARK ® On May 18, 2015, Fennec negotiated an amendment ("Amendment 1") to the OHSU Agreement, which expands Fennec's exclusive license to include the use of N-acetylcysteine as a standalone therapy and/or in combination with PEDMARK ® over a specified period. PEDMARK ® received FDA approval in September 2022, however at this time, due to significant uncertainty surrounding timing and magnitude of certain milestones, the Company has only recorded a royalty liability associated with net revenue. The term of the OHSU Agreement as amended by Amendment 1 expires on the date of the last to expire claim(s) covered in the patents licensed to Fennec or 8 years, whichever is later. The Company now has a licensed product with regulatory approval that is covered by the Orphan Drug Designation, the parties amended the term of the agreement. Sodium thiosulfate is currently protected by methods of use patents that the Company exclusively licensed from OHSU that expired in Europe in 2021 and that expire in the United States in 2038. The OHSU Agreement is terminable by either Fennec or OHSU in the event of a material breach of the agreement by either party after 45 days prior written notice. Fennec also has the right to terminate the OHSU Agreement at any time upon 60 days prior written notice and payment of all fees due to OHSU under the OHSU Agreement. The Company had accrued approximately $106 (1% net sales) in royalty expense to OHSU at December 31, 2023. Securities Class Action Suit Hope Medical Enterprises, Inc. Inter Partes Review (IPR) Challenges On October 29, 2021, Hope Medical Enterprises, Inc. (“Hope”) filed a Petition for inter partes review (IPR2022-00123) with the Patent Trial and Appeal Board (“PTAB”) of the USPTO to invalidate U.S. Patent No. 10,596,190 (the “‘190 Patent”), which is exclusively in-licensed from Oregon Health & Science University (“OHSU”) and relates to a method of using PEDMARK ® On October 29, 2021, Hope Medical Enterprises, Inc. (“Hope”) filed a Petition for inter partes review (IPR2022-00125) to invalidate our wholly owned U.S. Patent No. 10,792,363 (the “’363 Patent”), which relates to an anhydrous form of STS and its method of manufacture, which is the active pharmaceutical ingredient in the PEDMARK ® The USPTO has now granted three additional U.S. patents that cover the PEDMARK ® ® ® ® ® CIPLA Litigation On December 1, 2022, we received a letter dated November 30, 2022, notifying us that CIPLA Ltd. and CIPLA USA (“CIPLA”) submitted to the FDA an ANDA (ANDA No. 218028) for a generic version of PEDMARK ® ® ® Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, after receipt of a valid Paragraph IV notice, the Company may bring a patent infringement suit in a federal district court against CIPLA within 45 days from the receipt of the Notice Letter and if such a suit is commenced within the 45-day period, the Company is entitled to a 30 month stay on the FDA’s ability to give final approval to any proposed products that reference PEDMARK ® ® On January 10, 2023, we filed suit against the CIPLA entities in the United States District Court for the District of New Jersey (Case No. 2:23-cv-00123), for infringement of the ‘190 Patent, the ‘728 Patent, and the ‘984 Patent. On April 20, 2023, we filed an Amended Complaint to assert infringement of the ‘728 patent and the ‘984 Patent. On April 4, 2023, we were granted US 11,617,793 Patent (the “’793 Patent”) covering the formulation of the PEDMARK ® PEDMARQSI ® ® Executive Severance In the event of Mr. Raykov's termination with the Company other than for cause, the Company will be obligated to pay him a one-time severance payment equal to twelve months of salary (currently $585). In the event of Mr. Andrade’s termination with the Company other than for cause, the Company will be obligated to pay him a one-time severance payment equal to six months of salary (currently $212). In the event of Mr. Haigh’s termination with the Company other than for cause, the Company will be obligated to pay him a one-time severance payment equal to three Leases The Company has an operating lease in Research Triangle Park, North Carolina utilizing a small space within a commercial building. The operating lease has payments of $0.4 per month with no scheduled increases. This operating lease is terminable with 30 days’ notice and has no penalties or contingent payments due. On January 23, 2020, the Company entered into an Office Service Agreement (the “Office Service Agreement”) with Regus to lease office space in Hoboken, New Jersey. Per the terms of the Office Service Agreement, the monthly rent payments are $1. The Company was required to pay a security deposit of $2, which is the equivalent to two months of rent. The Office Service Agreement commenced on January 27, 2020, and terminated on July 31, 2020, thereafter the lease has been continuing on a month-to-month basis with either party being able to terminate the agreement by providing one months’ advance written notice of termination. On August 1, 2023, the Company entered into a second Office Service Agreement (the “Second Office Service Agreement”) with Regus to lease office space in Dublin, Ireland. Per the terms of the Second Office Service Agreement, the monthly rent payments are $2. The Company was required to pay a security deposit of $5, which is the equivalent of two months rent. The Second Office Service Agreement commenced on August 1, 2023 and terminates on January 31, 2025, thereafter the lease may continue on a month-to-month basis with either party being able to terminate the agreement by providing one month’s advance written notice of termination. The Second Office Service Agreement does not provide an implicit rate, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring the operating lease liability. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment. The Company uses an incremental borrowing rate consisting of the current prime rate plus 150 commenced after August 2023. The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term. December 31, 2023 Remaining lease terms (in months) 13 Discount rate 10 % Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands): Year Ending December 31, 2024 $ 23 2025 2 25 Less imputed interest 2 Total lease liabilities $ 23 Current operating lease liabilities $ 21 Non-current operating lease liabilities 2 Total lease liabilities $ 23 Employee Benefit Plan In May 2021, the Company established the Fennec Pharmaceuticals, Inc. 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. As of December 31, 2023 the Company does not offer matching contributions. |
Term Loans
Term Loans | 12 Months Ended |
Dec. 31, 2023 | |
Term Loans | |
Term Loans | 8. Term Loans On August 1, 2022, the Company entered into the SPA with the Investor in connection with the issuance of up to $45,000 of Notes, issuable in multiple tranches. On August 19, 2022, the Company closed on the initial tranche of $5,000, which has an Initial Conversion Price equal to $8.11 per share, which was calculated based on a 20% premium of the 5-day VWAP immediately prior to the announcement of the SPA. In connection with the first closing, the Company repaid in full its secured indebtedness with Bridge Bank in the amount of $5,000. The Notes become due on the maturity date, which is August 19, 2027. On September 23, 2022, the Company closed on the second tranche of the Note Financing in the amount of $20,000 (the “Second Closing Note”), which has an Initial Conversion Price equal to $7.89 per share, which was calculated based on a 20% premium of the 5-day VWAP immediately prior to September 20, 2022, which was the date the Company obtained FDA approval of PEDMARK ® A commitment fee of 2.0% of the Notes was payable under the SPA. Half half five On December 4, 2023, the Company closed a third tranche under the SPA in the amount of $5,000,000 (the “Third Closing Note”), which has an Initial Conversion Price equal to $7.89 per share, which was calculated based on a 20% premium of the 5-day VWAP immediately prior to September 20, 2022, which was the date the Company obtained FDA approval of PEDMARK ® Also on December 4, 2023, the Company entered into a First Amendment to the Securities Purchase Agreement (the “SPA Amendment”) with the Investor, which, among other things, extends the period that the Company may draw the remaining $15,000,000 under the SPA from December 31, 2023, to December 31, 2024. Subsequent draws are subject to mutual agreement of the Company and the Investor and will be represented by Notes that will also be convertible at a price equal to $7.89 per share. Cash interest on outstanding principal shall accrue at a rate of prime, plus 4.5% per annum, from the date of funding (11% as of December 31, 2023). Cash interest is due on the first business day of each calendar quarter (“Interest Date”). Payment-in-kind (“PIK”) interest will commence on funding date and accrue at a rate of 3.5% per annum. PIK interest will stop accruing on August 24, 2024. Any accrued PIK interest shall remain outstanding and be payable on each Interest Date and be added to the outstanding principal amount. The Company has accrued $1,219 in PIK interest and has classified the PIK interest in long-term liabilities. The SPA notes are convertible into fully paid, non-assessable share of common shares at any point after their issuance dates and before the maturity date. Any amount of the SPA notes may be converted into common shares so long as it does not create partial shares. The conversion rate is determined by dividing the conversion amount by the conversion price. Provisions of the PSA create legal, valid and enforceable liens on, and security interests in, all of the Company’s and each of its subsidiaries’ assets. Aggregate annual payments due on the SPA as of December 31, 2023, are as follows (in thousands): Years Ending December 31, Amount 2024 $ — 2025 — 2026 — 2027 30,000 Total future payments 30,000 Add: PIK interest 1,219 Less: unamortized debt discount (288) Total term loan, net of debt discount $ 30,931 In the event of default or change of control, all unpaid principal and all accrued and unpaid interest amounts (if any) become immediately due and payable. Events of default include, but are not limited to, a payment default, a material adverse change, and insolvency. The SPA facility is secured by all of the Company’s assets, including all capital stock held by the Company. Debt issuance costs of $175 were paid in cash for legal fees and to the Investor in 2022 and warrants valued at $441 were granted the Investor to secure access to the SPA. These amounts were capitalized and are being amortized over the access period of the SPA. Upon drawing tranche 1 through 3, the Company recorded a debt discount of $314, which was based on a pro-rata allocation of the issue costs to secure the SPA, reducing the capitalized amount by the same amount. The debt discount is being amortized over the life of the SPA. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | 9. Income Taxes The Company operates in U.S., Canadian and Ireland tax jurisdictions. Its income is subject to varying rates of tax and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another. A reconciliation of the combined Canadian federal and provincial income tax rate with the Company’s effective tax rate is as follows (in thousands except for percentage rates): Year Ended Year Ended December 31, December 31, 2023 2022 Domestic loss $ (12,301) $ (10,548) Foreign loss (3,744) (13,117) Loss before income taxes (16,045) (23,665) Expected statutory rate 26.50 % 26.50 % Expected provision for (recovery of) income tax (4,252) (6,271) Permanent differences 1,553 1,170 Change in valuation allowance 2,038 4,669 Effect of tax rate changes and other 661 432 Provision for income taxes $ — $ — The Canadian statutory income tax rate of 26.5 percent is comprised of federal income tax at approximately 15.0 percent and provincial income tax at approximately 11.5 percent. The primary temporary differences which gave rise to future income taxes (recovery) at December 31, 2023 and December 31, 2022: December 31, December 31, 2023 2022 Future tax assets: SR&ED expenditures $ 2,086 $ 2,086 Income tax loss carryforwards 37,143 30,007 Non-refundable investment tax credits 297 700 Share issue costs 73 77 Fixed and intangible assets 1,083 1,083 Debt discount 62 — 40,744 33,953 Less: valuation allowance (40,718) (33,927) Net future tax assets $ 26 $ 26 Tax Cuts and Jobs Act On December 22, 2017, the then President of the United States signed into law an Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (commonly known as “the Tax Cuts and Jobs Act” (“TCJA”)), which introduced a comprehensive set of tax reforms. The Tax Cuts and Jobs Act significantly revises U.S. tax law by, among other provisions, lowering the Company’s corporate tax rate from 34% to 21% and eliminating or reducing certain income tax deductions. In December 2017, in accordance with the SEC Staff Accounting Bulletin (“SAB”) 118–Income Tax Accounting Implications of the TCJA, the Company recorded tax effects on a provisional basis based on a reasonable estimate. The TCJA did not have a material impact on the Company's financial statements because its deferred temporary differences are fully offset by a valuation allowance and the Company does not have any offshore earnings from which to record the mandatory transition tax. During 2018, the Company completed its analysis under SAB 118 and no additional tax effects due to rate-remeasurement were required to be recorded. There are no current income taxes owed, but the Norgine deal will cause the Company to be closer to using its historical tax losses. Once those losses are used up, the Company will owe income taxes. As of December 31, 2023, the Company has unclaimed Scientific Research and Experimental Development ("SR&ED") expenditures, income tax loss carry-forwards and non-refundable investment tax credits. The unclaimed amounts and their expiry dates are as listed below: Province/ Federal State SR&ED expenditures (no expiry) $ 7,872 $ — Income tax loss carryforwards (expiry date): 2024 4,849 — 2025 6,143 — 2026 13,868 — 2027 8,136 — 2028 10,509 — 2029 8,185 2,116 2030 2,608 700 2031 3,378 789 2032 3,491 651 2033 1,789 655 2034 1,812 617 2035 1,803 941 2036 2,208 1,013 2037 4,641 1,638 2038 7,427 - 2039 9,587 - 2040 15,009 - 2041 13,556 - 2042 18,798 - 2043 — No expiration 37,204 24,837 Investment tax credits (expiry date): 2024 189 2025 82 2026 86 2027 47 |
Revision to Prior Period Financ
Revision to Prior Period Financial Statements | 12 Months Ended |
Dec. 31, 2023 | |
Revision to Prior Period Financial Statements | |
Revision to Prior Period Financial Statements | 10. Revision to Prior Period Financial Statements In preparing the annual report on Form 10-K for the year ended December 31, 2023, the Company determined that it overstated sales and marketing expenses associated with select distributors, which does not accurately match the expense to the proper period that related sales and marketing expenses were received. The Company determined that, based on the timeline of services provided by these distinct distributors, it would be more accurate to defer a portion of the sales and marketing expenses to future periods and amortize the remaining expense over the expected service period. The Company also determined that a portion of such expenses would be more accurately characterized as distribution fees and has presented such amounts as a reduction of revenues. These revisions resulted in adjustments to net product sales, sales and marketing expenses and current assets as previous reported in the Company’s September 30, 2023 condensed consolidated financial statements. Net product sales were adjusted down in the amount of $0.2 million, sales and marketing expenses were decreased by $1.2 million and current assets increased by $1.0 million as of September 30, 2023. The effect on our September 30, 2023 financial results are presented below. The effect of the revisions to the unaudited condensed consolidated financial statements is as follows (amount in thousands): Condensed Consolidated Balance Sheet (Unaudited) As of September 30, 2023 As Previously Reported Adjustments As Revised Prepaid expenses $ 247 $ 950 $ 1,197 Total current assets 18,946 950 19,896 Total assets $ 19,028 $ 950 $ 19,978 Accumulated deficit $ (216,563) $ (950) $ (215,613) Total shareholders' deficit (10,531) (950) (9,581) Total liabilities and shareholder's deficit $ (19,028) $ (950) $ (19,978) Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended Nine Months Ended September 30, 2023 September 30, 2023 As As Previously As Previously As Reported Adjustments Revised Reported Adjustments Revised PEDMARK® product sales, net $ 6,515 $ (219) $ 6,296 $ 11,517 $ (219) $ 11,298 Sales and marketing expense 3,384 (1,169) 2,215 8,255 (1,169) 7,086 Net loss (1,867) 950 (917) (13,363) 950 (12,413) Net loss attributable to common shareholders $ (1,867) $ 950 $ (917) $ (13,363) $ 950 $ (12,413) Basic net loss per common share $ (0.07) $ 0.04 $ (0.03) $ (0.50) $ 0.03 $ (0.47) Diluted net loss per common share $ (0.07) $ 0.04 $ (0.03) $ (0.50) $ 0.03 $ (0.47) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) For the Three Months Ended For the Nine Months Ended September 30, 2023 September 30, 2023 Total Total Accumulated Stockholders’ Accumulated Stockholders’ Deficit Equity Deficit Equity As Previously Reported Net loss $ (1,867) $ (1,867) $ (13,363) $ (13,363) Balance at September 30, 2023 $ (216,563) $ (10,531) $ (216,563) $ (10,531) Adjustments $ 950 $ 950 $ 950 $ 950 As Revised Net loss $ (917) $ (917) $ (12,413) $ (12,413) Balance at September 30, 2023 $ (215,613) $ (9,581) $ (215,613) $ (9,581) Condensed Consolidated Statement of Cash Flows (Unaudited) For the Nine Months Ended September 30, 2023 As Previously Reported Adjustments As Revised Cash Flows from Operating Activities: Net loss $ (13,363) $ 950 $ (12,413) Reconciliation of net loss to net cash used in operating activities: Prepaid expenses 523 (950) (427) Subtotal of non-cash charges 1,080 (950) 130 Net cash used in operating activities $ (12,283) $ - $ (12,283) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 11. Subsequent Events On March 17, 2024, the Company announced it had entered into an exclusive licensing agreement with Norgine to commercialize PEDMARQSI ® |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of Fennec and of all its wholly-owned subsidiaries. All inter-company transactions and balances have been eliminated upon consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that impact the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of revenue and expense during the reporting period. Significant estimates include revenue recognition, amount and timing of marketing and other services performed by certain distributors, allowance against trade receivables, measurement of stock-based compensation over the next twelve months from the date of issuance of the consolidated financial statements. Actual results could differ from those estimates. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. As of December 31, 2023, the Company had an operating lease in Ireland. This is the only asset located outside of the United States. |
Stock-Based Compensation | Stock-Based Compensation Under The |
Inventory | Inventory Inventories are valued under a standard costing methodology on a first-in, first-out basis and are stated at the lower of cost or net realizable value. The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. Capitalized costs of inventories mainly include third party manufacturing, logistics and distribution costs. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories. The manufacturing costs for PEDMARK ® ® |
Revenue Recognition | Revenue Recognition Under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. |
Net Product Revenue | Net Product Revenue On September 20, 2022, the FDA approved PEDMARK ® ® ® |
Product Sales Discounts and Allowances | Product Sales Discounts and Allowances The Company records U.S. based revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns and other allowances that are offered within contracts between the Company and its Customers, health care providers, payors and other indirect customers relating to the sales of its products. These reserves are based on the amounts to be claimed on the related sales and are classified as a contra-asset or a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted Customer buying and payment patterns, and the Company’s historical experience that will develop over time as PEDMARK ® The Company also utilizes select distributors to introduce its product into global markets. These distributors take on the function of shipping, storage, marketing and other services related to the sale of our product. We record distribution and other fees paid to these distributors as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received. If both conditions are met, we record the consideration paid to the distributor as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale. Chargebacks: Discounts for Prompt Payment: Rebates: ® Co-payment Assistance: Other Customer Credits: Distribution and Other Fees: We pay distribution and other fees to certain customers in connection with the sales of our products. We record distribution and other fees paid to our customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received. If both conditions are met, we record the consideration paid to the customer as an operating expense. These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale. The following table summarizes net product revenues for PEDMARK ® Year Ended December 31, December 31, 2023 2022 Product revenues: Gross product revenues $ 23,782 $ 1,769 Discounts and allowances (2,530) (234) Net product revenues $ 21,252 $ 1,535 For the years ended December 31, 2023 and 2022, the Company had 4 distributors and 3 distributors that represented more than 10% of net sales, respectively. The activities and ending allowance balances for each significant category of discounts and allowances for PEDMARK ® Chargebacks, Rebates, Customer Discounts for Fees/Credits Prompt Pay and and Co-Pay In thousands Other Allowances Assistance Totals Balance at December 31, 2021 $ — $ — $ — Provision related to sales made in: Current period 72 163 235 Prior periods — — — Payments and customer credits issued (1) — (1) Balance at December 31, 2022 $ 71 $ 163 $ 234 Provision related to sales made in: Current period 1,164 600 1,764 Prior periods — — — Payments and customer credits issued (870) (333) (1,203) Balance at December 31, 2023 $ 365 $ 430 $ 795 The allowances for chargebacks, fees due to Customers, rebates and discounts for prompt payment are recorded as a contra-asset to accounts receivable, while Medicaid rebates and return allowances are in accrued liabilities in the accompanying Consolidated Balance Sheets. |
Trade Receivables | Trade Receivables The Company records gross trade |
Cost of Products Sold | Cost of Products Sold Cost of products sold is related to the Company's product revenues for PEDMARK ® ® ® ® capitalized, $1.4 million was capitalized as work in process and raw materials, $0.8 million was capitalized into finished goods. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash equivalents consist of highly liquid investments with original maturities at the date of purchase of three months or less. The Company places its cash and cash equivalents in investments held by highly rated financial institutions in accordance with its investment policy designed to protect the principal investment. As of December 31, 2023, the Company had $13.3 million in cash and money market accounts (2022- $23.8 million). Money market investments typically have minimal risks. While the Company has not experienced any loss or write-down of its money market investments, the amounts it holds in money market accounts are substantially above the $250,000 amount insured by the FDIC and may lose value. |
Financial Instruments | Financial Instruments Financial instruments recognized on the balance sheets at December 31, 2023 and 2022, consist of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities and term loans, the carrying values of which approximate fair value due to their relatively short time to maturity or interest rates that approximate market interest rates. The Company does not hold or issue financial instruments for trading. The Company’s investment policy is to manage investments to achieve, in the order of importance, the financial objectives of preservation of principal, liquidity and return on investment. Investments, when made, are made in U.S. or Canadian bank securities, commercial paper of U.S. or Canadian industrial companies, utilities, financial institutions and consumer loan companies, and securities of foreign banks provided the obligations are guaranteed or carry ratings appropriate to the policy. Securities must have a minimum Dun & Bradstreet rating of A for bonds or R1 low for commercial paper. The policy risks are primarily the opportunity cost of the conservative nature of the allowable investments. The Company has chosen to avoid investments of a trading or speculative nature to preserve cash. |
Common Shares and Warrants | Common Shares and Warrants The Company has 0.2 million warrants with a weighted average strike price of $7.71 outstanding to purchase common shares that have a weighted average life of 4.05 years. |
Research and Development Costs and Investment Tax Credits | Research and Development Costs and Investment Tax Credits Research costs, including employee compensation, laboratory fees, lab supplies, and research and testing performed under contract by third parties, are expensed as incurred. Development costs, including drug substance costs, clinical study expenses and regulatory expenses are expensed as incurred. Investment tax credits, which are earned as a result of qualifying research and development expenditures, are recognized when the expenditures are made and their realization is reasonably assured. They are applied to reduce related capital costs and research and development expenses in the year recognized. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, and instrument. The Company’s trade receivables includes amounts billed to Customers, both specialty and select global distributors, for product sales of PEDMARK ® |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates. The Company has deferred tax assets, which are subject to periodic recoverability assessments. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. As of December 31, 2023, and 2022, we maintained a full valuation allowance against our deferred tax assets. The provisions of the Financial Accounting Standards Board (“FASB”) ASC 740-10, Uncertainty in Income Taxes, address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, we may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. |
Foreign Currency Translation | Foreign Currency Translation The U.S. dollar is the functional currency for the Company’s consolidated operations. All gains and losses from currency translations are included in results of operations. |
Loss Per Share | Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the year. Diluted net loss per share is computed using the same method, except the weighted average number of common shares outstanding includes convertible debentures, restricted share units, stock options and warrants, if dilutive, as determined using the if-converted method and treasury methods. Accordingly, warrants to purchase 0.2 million of our common shares, restricted share units of 0.2 million to obtain our common shares, and options to purchase 4.8 million of our common shares at December 31, 2023, were not included in loss per share. Such options would have an antidilutive effect. In 2022, warrants to purchase 0.2 million of our common shares, restricted share units to obtain 0.04 million of our common shares and options to purchase 4.5 million common shares were excluded from the computation of loss per share as their inclusion would have been antidilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40). The new standard eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity's own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity's own equity. This ASU will be effective for the year ended December 31, 2024. The Company adopted this ASU in Q1 of 2023. In June 2022, the FASB issued Accounting Standards Update ("ASU") 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, which (1) clarifies the guidance in Topic 820 on the fair value measurement of an equity security that is subject to contractual restrictions that prohibit the sale of an equity security and (2) requires specific disclosures related to such an equity security. This ASU will be effective for the year ended December 31, 2024. The Company adopted this ASU in 2023. In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments – Credit Losses (Topic 326) and subsequently related amendments (ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2019-10, ASU 2019-11 and ASU 2022-02). This guidance replaces the existing incurred loss impairment guidance and establishes a single allowance framework for financial assets carried at amortized cost based on expected credit losses. The estimate of expected credit losses requires the incorporation of historical information, current conditions, and reasonable and supportable forecasts. This ASU will be effective for the year ended December 31, 2023. The Company is currently evaluating the effect the adoption of this ASU will have on the consolidated financial statements. In December 2023 , , |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Schedule of PEDMARK Revenues, Net | Year Ended December 31, December 31, 2023 2022 Product revenues: Gross product revenues $ 23,782 $ 1,769 Discounts and allowances (2,530) (234) Net product revenues $ 21,252 $ 1,535 |
Schedule of PEDMARK Revenues, Discounts and Allowances | Chargebacks, Rebates, Customer Discounts for Fees/Credits Prompt Pay and and Co-Pay In thousands Other Allowances Assistance Totals Balance at December 31, 2021 $ — $ — $ — Provision related to sales made in: Current period 72 163 235 Prior periods — — — Payments and customer credits issued (1) — (1) Balance at December 31, 2022 $ 71 $ 163 $ 234 Provision related to sales made in: Current period 1,164 600 1,764 Prior periods — — — Payments and customer credits issued (870) (333) (1,203) Balance at December 31, 2023 $ 365 $ 430 $ 795 |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Loss per Share | |
Schedule of Antidilutive Securities Excluded from Net Loss Per Share | Year Ended December 31, 2023 2022 Options to purchase common shares 4,798 4,539 Restricted share units to obtain common shares 218 35 Warrants to purchase common shares 150 150 |
Schedule of Earnings Per Share, Basic and Diluted | Year Ended December 31, 2023 2022 Numerator: Net loss $ (16,045) $ (23,714) Denominator: Weighted-average common shares, basic 26,574 26,275 Dilutive effect of stock options — — Dilutive effect of warrants — — Dilutive effect of restricted share units — — Incremental dilutive shares — — Weighted-average common shares, diluted 26,574 26,275 Net loss per share, basic and diluted $ (0.60) $ (0.90) |
Stock options (Tables)
Stock options (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of Share-Based Compensation, Stock Option Volatility Measurements | Year Ended December 31, 2023 Year Ended December 31, 2022 Expected dividend - % - % Risk-free interest rate 3.58 - 5.31 % 1.18 - 3.96 % Expected volatility 59 - 167 % 150 - 181 % Expected life 1.50 - 6 years 5 - 6 years |
Schedule of Restricted Share Unit Activity | Number of Restricted US Denominated RSU's Share Units (thousands) Outstanding at December 31, 2021 219 Awarded — Forfeited (86) Released (98) Outstanding at December 31, 2022 35 Awarded 365 Forfeited (96) Released (86) Outstanding at December 31, 2023 218 |
Currency, U.S. Dollar [Member] | |
Schedule of Stock Option Activity | Number Outstanding and Exercisable at Weighted Average Strike Price Weighted Average December 31, 2023 December 31, 2023 Remaining Life (in thousands) US Dollars (years) 4,798 $6.27 5.58 |
Schedule of Stock Options by Exercise Price Range | Number of Options Weighted (in thousands) Range Average Outstanding and exercisable at December 31, 2021 4,259 $ 0.45 – 12.59 $ 5.13 Granted 1,015 5.59 - 8.10 6.50 Exercised (273) 0.45 - 8.38 3.29 Forfeited (462) 5.59 - 8.10 6.79 Outstanding and exercisable at December 31, 2022 4,539 $ 0.45 – 12.59 $ 5.43 Granted 1,245 7.35 - 9.05 8.25 Exercised (586) 0.72 - 7.99 3.18 Forfeited (400) 4.08 - 8.32 7.45 Outstanding and exercisable at December 31, 2023 4,798 $ 4.08 - 10.96 $ 6.27 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Schedule of Assets/Liabilities Measured at Fair Value on Recurring Basis | Fair Value Measurement at December 31, 2023 and December 31, 2022 (in thousands) Quoted Price in Active Market for Identical Significant Other Significant Instruments Observable Inputs Unobservable Inputs Level 1 Level 2 Level 3 Total 2023 2022 2023 2022 2023 2022 2023 2022 Assets Cash and cash equivalents $ 1,340 (1) 307 (1) 11,929 23,467 — — 13,269 23,774 Processa common shares 17 (2) 56 — — — — 17 56 (1) The Company held approximately, $1,340 in cash as of December 31, 2023, of which approximately $473 was in Canadian funds and $97 in Euro (both translated into U.S. dollars). As of December 31, 2022, the Company held approximately $ 307 , of which approximately $33 was in Canadian funds (translated into U.S. dollars). (2) The Company has 41 unrestricted common shares of Processa (PSCA). |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Schedule of Share-Based Compensation, Stock Option Activity | Number of Warrants Weighted (in thousands) Range Average Outstanding and exercisable at December 31, 2021 $ 39 $ 6.80 $ 6.80 Granted 111 8.11 8 Outstanding and exercisable at December 31, 2022 $ 150 $ 7.71 $ 7.71 Granted — — — Outstanding and exercisable at December 31, 2023 $ 150 $ 7.71 $ 7.71 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Schedule of components of operating lease liability | December 31, 2023 Remaining lease terms (in months) 13 Discount rate 10 % Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands): Year Ending December 31, 2024 $ 23 2025 2 25 Less imputed interest 2 Total lease liabilities $ 23 Current operating lease liabilities $ 21 Non-current operating lease liabilities 2 Total lease liabilities $ 23 |
Term Loans (Tables)
Term Loans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Term Loans | |
Schedule of Aggregate Annual Term-Loan Payments | Years Ending December 31, Amount 2024 $ — 2025 — 2026 — 2027 30,000 Total future payments 30,000 Add: PIK interest 1,219 Less: unamortized debt discount (288) Total term loan, net of debt discount $ 30,931 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of Income Taxes, Combined US and Canadian Effective Tax Rate | Year Ended Year Ended December 31, December 31, 2023 2022 Domestic loss $ (12,301) $ (10,548) Foreign loss (3,744) (13,117) Loss before income taxes (16,045) (23,665) Expected statutory rate 26.50 % 26.50 % Expected provision for (recovery of) income tax (4,252) (6,271) Permanent differences 1,553 1,170 Change in valuation allowance 2,038 4,669 Effect of tax rate changes and other 661 432 Provision for income taxes $ — $ — |
Schedule of Net Future Tax Assets | December 31, December 31, 2023 2022 Future tax assets: SR&ED expenditures $ 2,086 $ 2,086 Income tax loss carryforwards 37,143 30,007 Non-refundable investment tax credits 297 700 Share issue costs 73 77 Fixed and intangible assets 1,083 1,083 Debt discount 62 — 40,744 33,953 Less: valuation allowance (40,718) (33,927) Net future tax assets $ 26 $ 26 |
Schedule of Unclaimed Tax Credits and Expiration Dates | Province/ Federal State SR&ED expenditures (no expiry) $ 7,872 $ — Income tax loss carryforwards (expiry date): 2024 4,849 — 2025 6,143 — 2026 13,868 — 2027 8,136 — 2028 10,509 — 2029 8,185 2,116 2030 2,608 700 2031 3,378 789 2032 3,491 651 2033 1,789 655 2034 1,812 617 2035 1,803 941 2036 2,208 1,013 2037 4,641 1,638 2038 7,427 - 2039 9,587 - 2040 15,009 - 2041 13,556 - 2042 18,798 - 2043 — No expiration 37,204 24,837 Investment tax credits (expiry date): 2024 189 2025 82 2026 86 2027 47 |
Revision to Prior Period Fina_2
Revision to Prior Period Financial Statements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revision to Prior Period Financial Statements | |
Schedule of Revisions to the Unaudited Condensed Consolidated Balance Sheet | Condensed Consolidated Balance Sheet (Unaudited) As of September 30, 2023 As Previously Reported Adjustments As Revised Prepaid expenses $ 247 $ 950 $ 1,197 Total current assets 18,946 950 19,896 Total assets $ 19,028 $ 950 $ 19,978 Accumulated deficit $ (216,563) $ (950) $ (215,613) Total shareholders' deficit (10,531) (950) (9,581) Total liabilities and shareholder's deficit $ (19,028) $ (950) $ (19,978) |
Schedule of Revisions to the Unaudited Condensed Consolidated Statement of Operations | Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended Nine Months Ended September 30, 2023 September 30, 2023 As As Previously As Previously As Reported Adjustments Revised Reported Adjustments Revised PEDMARK® product sales, net $ 6,515 $ (219) $ 6,296 $ 11,517 $ (219) $ 11,298 Sales and marketing expense 3,384 (1,169) 2,215 8,255 (1,169) 7,086 Net loss (1,867) 950 (917) (13,363) 950 (12,413) Net loss attributable to common shareholders $ (1,867) $ 950 $ (917) $ (13,363) $ 950 $ (12,413) Basic net loss per common share $ (0.07) $ 0.04 $ (0.03) $ (0.50) $ 0.03 $ (0.47) Diluted net loss per common share $ (0.07) $ 0.04 $ (0.03) $ (0.50) $ 0.03 $ (0.47) |
Schedule of Revisions to the Unaudited Condensed Consolidated Statement of Stockholders' Equity | Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) For the Three Months Ended For the Nine Months Ended September 30, 2023 September 30, 2023 Total Total Accumulated Stockholders’ Accumulated Stockholders’ Deficit Equity Deficit Equity As Previously Reported Net loss $ (1,867) $ (1,867) $ (13,363) $ (13,363) Balance at September 30, 2023 $ (216,563) $ (10,531) $ (216,563) $ (10,531) Adjustments $ 950 $ 950 $ 950 $ 950 As Revised Net loss $ (917) $ (917) $ (12,413) $ (12,413) Balance at September 30, 2023 $ (215,613) $ (9,581) $ (215,613) $ (9,581) |
Schedule of Revisions to the Unaudited Condensed Consolidated Statement of Cash Flows | Condensed Consolidated Statement of Cash Flows (Unaudited) For the Nine Months Ended September 30, 2023 As Previously Reported Adjustments As Revised Cash Flows from Operating Activities: Net loss $ (13,363) $ 950 $ (12,413) Reconciliation of net loss to net cash used in operating activities: Prepaid expenses 523 (950) (427) Subtotal of non-cash charges 1,080 (950) 130 Net cash used in operating activities $ (12,283) $ - $ (12,283) |
Nature of Business and Liquid_2
Nature of Business and Liquidity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Dec. 04, 2023 | Sep. 23, 2022 | Aug. 19, 2022 | Aug. 01, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 17, 2024 | |
Nature of Business and Going Concern [Line Items] | |||||||||
Loss from operations | $ 12,771,000 | $ 22,589,000 | |||||||
Net loss | $ (917,000) | $ (12,413,000) | 16,045,000 | 23,714,000 | |||||
Accumulated deficit | $ 215,613,000 | 215,613,000 | (219,245,000) | (203,200,000) | |||||
Cash flows from operating activities | $ (12,283,000) | $ (17,143,000) | $ (18,058,000) | ||||||
Petrichor Financing | Securities Purchase Agreements | Convertible Note Borrowings | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Maximum borrowing capacity | $ 45,000,000 | ||||||||
Commitment fee percentage | 2% | ||||||||
Exercise price of warrants issued | $ 8.11 | ||||||||
Exercise term of warrants | 5 years | ||||||||
Petrichor Financing | Securities Purchase Agreements | First Closing Note | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Borrowings, face amount | $ 5,000,000 | ||||||||
Initial conversion price | $ 8.11 | ||||||||
Premium over 5-day VWAP | 20% | ||||||||
VWAP term | 5 days | ||||||||
Petrichor Financing | Securities Purchase Agreements | Second Closing Note | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Borrowings, face amount | $ 20,000,000 | ||||||||
Initial conversion price | $ 7.89 | ||||||||
Premium over 5-day VWAP | 20% | ||||||||
VWAP term | 5 days | ||||||||
Petrichor Financing | Securities Purchase Agreements | Third Closing Note | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Borrowings, face amount | $ 5,000,000 | ||||||||
Initial conversion price | $ 7.89 | ||||||||
Premium over 5-day VWAP | 20% | ||||||||
VWAP term | 5 days | ||||||||
Petrichor Financing | Securities Purchase Agreements | First Closing Warrant | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Commitment fees payable in warrants | 50% | ||||||||
Common shares available through issuance of warrants | 55,498 | ||||||||
Petrichor Financing | Securities Purchase Agreements | Second Closing Warrant | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Common shares available through issuance of warrants | 55,498 | ||||||||
Commitment fees payable in cash or warrants | 50% | ||||||||
Exercise price of warrants issued | $ 8.11 | ||||||||
Exercise term of warrants | 5 years | ||||||||
Petrichor Financing | SPA First Amendment | Third Closing Note | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Remaining borrowing capacity | $ 15,000,000 | ||||||||
Initial conversion price | $ 7.89 | ||||||||
Petrichor Financing | SPA First Amendment | Third Closing Note | Maximum | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Maximum borrowing capacity | $ 15,000,000 | ||||||||
Bridge Bank | Bridge Bank Term Loan | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
Repayment of term loan | $ 5,000,000 | $ 5,000,000 | |||||||
Subsequent Event | Licensing Agreement | Norgine Ltd. | |||||||||
Nature of Business and Going Concern [Line Items] | |||||||||
License agreement funding received | $ 43,000,000 | ||||||||
License agreement funding, potential milestone payments | $ 230,000,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Allowance for doubtful accounts | $ 300 | ||
Discounts for prompt payment | 0.65% | ||
Percentage of prompt payment discounts expected to pay out | 100% | ||
Cash | $ 307 | ||
FDIC insured amount | $ 250,000 | ||
Cash, Savings and Money Market Accounts | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash | $ 13,300 | $ 23,800 | |
Warrants | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive securities excluded from EPS | 150 | 150 | |
Restricted shares | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive securities excluded from EPS | 218 | 35 | |
Employee Stock Option [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Antidilutive securities excluded from EPS | 4,798 | 4,539 | |
Warrants | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Warrants outstanding | 150 | 150 | 39 |
Warrants exercise price | $ 7.71 | $ 7.71 | $ 6.80 |
Exercise term of warrants | 4 years 18 days |
Significant Accounting Polici_5
Significant Accounting Policies - Revenue recognition (Details) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Oct. 30, 2020 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenues | $ 6,296 | $ 11,298 | $ 21,252 | $ 1,535 | |
PEDMARK | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Percentage of royalties | 1% | ||||
Revenues | $ 21,252 | $ 1,535 | |||
Processa Pharmaceuticals, Inc | License agreement | Restricted shares | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Shares to be issued under agreement | 41 |
Significant Accounting Polici_6
Significant Accounting Policies - Product Sales Discounts and Allowances (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Gross product revenues | $ 23,782 | $ 1,769 | ||
Discounts and allowances | (2,530) | (234) | ||
Net product revenues | $ 6,296 | $ 11,298 | 21,252 | 1,535 |
PEDMARK | ||||
Disaggregation of Revenue [Line Items] | ||||
Net product revenues | $ 21,252 | $ 1,535 |
Significant Accounting Polici_7
Significant Accounting Policies - Product Sales Discounts and Allowances Continued (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Provision for discounts and allowances, beginning balance | $ 234 | |
Current period | 1,764 | $ 235 |
Payments and customer credits issued | (1,203) | (1) |
Provision for discounts and allowances, ending balance | 795 | 234 |
Chargebacks, Discounts for Prompt pay and Other allowances | ||
Provision for discounts and allowances, beginning balance | 71 | |
Current period | 1,164 | 72 |
Payments and customer credits issued | (870) | (1) |
Provision for discounts and allowances, ending balance | 365 | 71 |
Rebates, Customer Fees/Credits and Co-pay Assistance | ||
Provision for discounts and allowances, beginning balance | 163 | |
Current period | 600 | 163 |
Payments and customer credits issued | (333) | |
Provision for discounts and allowances, ending balance | $ 430 | $ 163 |
Significant Accounting Polici_8
Significant Accounting Policies - Cost of Products Sold (Details) - PEDMARK $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Percentage of royalties | 1% |
Manufacturing costs capitalized to inventory | $ 2.2 |
Manufacturing costs capitalized to inventory, work-in-process | 1.4 |
Manufacturing costs capitalized to inventory, finished goods | $ 0.8 |
Loss per Share - Computation of
Loss per Share - Computation of Basic and Diluted (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||||
Net loss | $ 917 | $ 12,413 | $ (16,045) | $ (23,714) |
Denominator: | ||||
Weighted-average common shares, basic | 26,574 | 26,275 | ||
Weighted-average common shares, dilutive | 26,574 | 26,275 | ||
Basic net loss per common share | $ (0.03) | $ (0.47) | $ (0.60) | $ (0.90) |
Diluted net loss per common share | $ (0.03) | $ (0.47) | $ (0.60) | $ (0.90) |
Loss per Share - Outstanding Op
Loss per Share - Outstanding Options and Warrants (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Stock Option | ||
Antidilutive securities excluded from EPS | 4,798 | 4,539 |
Restricted Share Units to Obtain Common Shares | ||
Antidilutive securities excluded from EPS | 218 | 35 |
Warrants to Purchase Common Shares | ||
Antidilutive securities excluded from EPS | 150 | 150 |
Stock Options - Options Granted
Stock Options - Options Granted Under The Stock Option Plan Exercisable In Canadian Dollars And U.S Dollars (Details) - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Stock Option [Member] | ||
Vesting period | 3 years | |
Expiration term | 10 years | |
Currency, U.S. Dollar [Member] | ||
Number of Options Outstanding and Exercisable at Beginning | 4,539 | 4,259 |
Number of Options Granted | 1,245 | 1,015 |
Number of Options Exercised | (586) | (273) |
Number of Options Forfeited | (400) | (462) |
Number of Options Outstanding and Exercisable at Ending | 4,798 | 4,539 |
Weighted Average Exercise Price Outstanding and Exercisable at Beginning | $ 5.43 | $ 5.13 |
Weighted- Average Granted | 8.25 | 6.50 |
Weighted- Average Exercised | 3.18 | 3.29 |
Weighted- Average Forfeited or expired | 7.45 | 6.79 |
Weighted Average Exercise Price Outstanding and Exercisable at Ending | 6.27 | 5.43 |
Currency, U.S. Dollar [Member] | Minimum | ||
Outstanding and Exercisable Range | 0.45 | 0.45 |
Granted Range | 7.35 | 5.59 |
Exercised Range | 0.72 | 0.45 |
Forfeited or expired Range | 4.08 | 5.59 |
Outstanding and Exercisable Range | 4.08 | 0.45 |
Currency, U.S. Dollar [Member] | Maximum | ||
Outstanding and Exercisable Range | 12.59 | 12.59 |
Granted Range | 9.05 | 8.10 |
Exercised Range | 7.99 | 8.38 |
Forfeited or expired Range | 8.32 | 8.10 |
Outstanding and Exercisable Range | $ 10.96 | $ 12.59 |
Stock Options - Price In US Dol
Stock Options - Price In US Dollars (Details) - U.S. Dollars - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number Outstanding and Exercisable | 4,798 | 4,539 | 4,259 |
Weighted Average Strike Price in US Dollars | $ 6.27 | ||
Weighted Average Remaining Life (years) | 5 years 6 months 29 days |
Stock Options - Options Grant_2
Stock Options - Options Granted Based On The Black Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Minimum | ||
Risk-free interest rate | 3.58% | 1.18% |
Expected volatility | 59% | 150% |
Expected life | 1 year 6 months | 5 years |
Maximum | ||
Risk-free interest rate | 5.31% | 3.96% |
Expected volatility | 167% | 181% |
Expected life | 6 years | 6 years |
Stock options - Restricted Shar
Stock options - Restricted Share Units Activity (Details) - USD ($) shares in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
RSU expense recognized | $ 1.3 | $ 0.3 | |
Equity Incentive Plan | US Denominated RSU's | |||
US Denominated RSU's | |||
Outstanding RSUs at December 31 | 218 | 35 | 219 |
RSU's awarded | 365 | 0 | |
RSU's forfeited | (96) | (86) | |
RSU's released | (86) | (98) | |
Equity Incentive Plan | US Denominated RSU's | Vesting on the first anniversary date of the grant | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 3 years | ||
Vesting percentage | 33% | ||
Equity Incentive Plan | US Denominated RSU's | Vesting on the last day of each subsequent month | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting percentage | 4.17% |
Stock options - Additional Info
Stock options - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 12 Months Ended | ||
Jun. 24, 2010 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Intrinsic value of options exercised in period | $ 2,970 | ||
General and Administrative Expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated Share-based Compensation Expense | $ 5,400 | $ 4,200 | |
Plan Maximum Amendment | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares issuable under Stock Option Plan | 6.8 | ||
Percentage Of Total Number Of Share Issued and Outstanding | 25% | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares issuable under Stock Option Plan | 6.7 | ||
Weighted average fair value of options granted and or vested | $ 4.73 | $ 5.43 | |
Intrinsic value of options exercisable | $ 23,800 | ||
Fair value of options vested in period | $ 6,400 | ||
Expiration period | 10 years |
Fair Value Measurements - Asset
Fair Value Measurements - Assets/Liabilities Measured at Fair Value (Details) - USD ($) shares in Thousands, $ in Thousands | Oct. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Cash and cash equivalents | $ 13,269 | $ 23,774 | |
Quoted Price in Active Markets for Identical Instruments Level 1 | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Cash and cash equivalents | 1,340 | 307 | |
Significant Other Observable Inputs Level 2 | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Cash and cash equivalents | 11,929 | 23,467 | |
Significant Unobservable Inputs Level 3 | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Cash and cash equivalents | 0 | 0 | |
Processa Pharmaceuticals, Inc | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Processa common shares | 17 | 56 | |
Processa Pharmaceuticals, Inc | Quoted Price in Active Markets for Identical Instruments Level 1 | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Processa common shares | 17 | 56 | |
Processa Pharmaceuticals, Inc | Significant Unobservable Inputs Level 3 | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Processa common shares | $ 0 | $ 0 | |
License agreement | Processa Pharmaceuticals, Inc | Restricted shares | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Shares to be issued under agreement | 41 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Assets and Liabilities Measured On Recurring Basis [Line Items] | |||
Cash | $ 307 | ||
Quoted Price in Active Markets for Identical Instruments Level 1 | |||
Fair Value Assets and Liabilities Measured On Recurring Basis [Line Items] | |||
Cash | $ 1,340 | ||
Quoted Price in Active Markets for Identical Instruments Level 1 | Canadian funds translated into USD | |||
Fair Value Assets and Liabilities Measured On Recurring Basis [Line Items] | |||
Cash | $ 473 | $ 33 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Common Stock (Details) - Warrants - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Class of Warrant or Right [Line Items] | ||
Common shares issuable upon exercise of outstanding warrants, beginning balance | 150 | 39 |
Granted warrants during period | 0 | 111 |
Warrants outstanding | 150 | 150 |
Common shares issuable upon exercise of outstanding warrants, ending balance | 150 | 150 |
Weighted-average exercise price, beginning of period | $ 7.71 | $ 6.80 |
Granted warrants during period, weighted-average price | 0 | 8.11 |
Weighted-average exercise price, end of period | 7.71 | 7.71 |
Weighted Average | ||
Class of Warrant or Right [Line Items] | ||
Weighted-average exercise price, beginning of period | 7.71 | 6.80 |
Granted warrants during period, weighted-average price | 0 | 8 |
Weighted-average exercise price, end of period | $ 7.71 | $ 7.71 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 12 Months Ended | |
May 18, 2015 | Dec. 31, 2023 USD ($) | |
Oregon Health & Science University Agreement | ||
Licensing term OHSU agreement | 8 years | |
Days notice required to terminate OHSU agreement | 45 days | |
Days notice required by Fennec to terminate OHSU agreement | 60 days | |
Accrued royalty expenses | $ 106,000 | |
Percentage of royalties | 1% | |
Lease Contingencies | Triangle Park, North Carolina | ||
Monthly lease expense | $ 400,000 | |
Operating lease, number of scheduled payment increases | 0 | |
Operating lease, days notice required to terminate agreement | 30 days | |
Operating lease, penalties and contingent payments payable | $ 0 | |
Lease Contingencies | Hoboken, New Jersey | Office Service Agreement | ||
Monthly lease expense | 1,000 | |
Security deposit | 2,000 | |
Lease Contingencies | Dublin, Ireland | Office Service Agreement | ||
Monthly lease expense | 2,000 | |
Security deposit | $ 5,000 | |
Variable rate over prime | 1.50% | |
CIPLA ANDA Litigation | ||
Days following receipt of Notice Letter to file patent infringement suit | 45 days | |
Duration of FDA's ability to give final approval to proposed products that reference PEDMARK | 30 months | |
PEDMARK's Orphan Drug Exclusivity period | 7 years | |
PEDMARK's exclusivity period under PUMA | 10 years | |
Executive Severance | Rostislav Raykov | ||
Severance payments due | $ 585,000 | |
Number of severance payments | 1 | |
Severance payment term | twelve | |
Executive Severance | Robert Andrade | ||
Severance payments due | $ 212,000 | |
Number of severance payments | 1 | |
Severance payment term | six | |
Executive Severance | Adrian Haigh | ||
Severance payments due | $ 110,000 | |
Number of severance payments | 1 | |
Severance payment term | P3M |
Commitments and Contingencies -
Commitments and Contingencies - Lease Agreements (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Current operating lease liabilities | $ 21 |
Non-current operating lease liabilities | $ 2 |
Lease Contingencies | Office Service Agreement | Dublin, Ireland | |
Remaining lease terms (in months) | 13 months |
Discount rate | 10% |
2024 | $ 23 |
2025 | 2 |
lease liabilities to be paid before imputed interest | 25 |
lease liabilities imputed interest | 2 |
Total lease liabilities | 23 |
Current operating lease liabilities | 21 |
Non-current operating lease liabilities | 2 |
Total lease liabilities | $ 23 |
Term Loans (Details)
Term Loans (Details) - USD ($) | 12 Months Ended | |||||
Dec. 04, 2023 | Sep. 23, 2022 | Aug. 19, 2022 | Aug. 01, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Term Loans [Line Items] | ||||||
Debt discount | $ (288,000) | $ (361,000) | ||||
Petrichor Financing | Securities Purchase Agreements | Convertible Note Borrowings | ||||||
Term Loans [Line Items] | ||||||
Maximum borrowing capacity | $ 45,000,000 | |||||
Commitment fee percentage | 2% | |||||
Exercise price of warrants issued | $ 8.11 | |||||
Exercise term of warrants | 5 years | |||||
Debt issuance costs | $ 175,000 | |||||
Debt discount | (314,000) | |||||
Fair value warrants | $ 441,000 | |||||
Cash interest accrual rate over Prime | 4.50% | |||||
Cash interest accrual rate | 11% | |||||
Accrual rate, PIK interest | 3.50% | |||||
Accrued Paid-in-Kind Interest | $ 1,219,000,000 | |||||
Petrichor Financing | Securities Purchase Agreements | First Closing Note | ||||||
Term Loans [Line Items] | ||||||
Borrowings, face amount | $ 5,000,000 | |||||
Initial conversion price | $ 8.11 | |||||
Premium over 5-day VWAP | 20% | |||||
VWAP term | 5 days | |||||
Petrichor Financing | Securities Purchase Agreements | Second Closing Note | ||||||
Term Loans [Line Items] | ||||||
Borrowings, face amount | $ 20,000,000 | |||||
Initial conversion price | $ 7.89 | |||||
Premium over 5-day VWAP | 20% | |||||
VWAP term | 5 days | |||||
Petrichor Financing | Securities Purchase Agreements | Third Closing Note | ||||||
Term Loans [Line Items] | ||||||
Borrowings, face amount | $ 5,000,000 | |||||
Initial conversion price | $ 7.89 | |||||
Premium over 5-day VWAP | 20% | |||||
VWAP term | 5 days | |||||
Petrichor Financing | Securities Purchase Agreements | First Closing Warrant | ||||||
Term Loans [Line Items] | ||||||
Commitment fees payable in warrants | 50% | |||||
Common shares available through issuance of warrants | 55,498 | |||||
Petrichor Financing | Securities Purchase Agreements | Second Closing Warrant | ||||||
Term Loans [Line Items] | ||||||
Common shares available through issuance of warrants | 55,498 | |||||
Commitment fees payable in cash or warrants | 50% | |||||
Exercise price of warrants issued | $ 8.11 | |||||
Exercise term of warrants | 5 years | |||||
Petrichor Financing | SPA First Amendment | Third Closing Note | ||||||
Term Loans [Line Items] | ||||||
Remaining borrowing capacity | $ 15,000,000 | |||||
Initial conversion price | $ 7.89 | |||||
Petrichor Financing | SPA First Amendment | Third Closing Note | Maximum | ||||||
Term Loans [Line Items] | ||||||
Maximum borrowing capacity | $ 15,000,000 | |||||
Bridge Bank | Bridge Bank Term Loan | ||||||
Term Loans [Line Items] | ||||||
Repayment of term loan | $ 5,000,000 | $ 5,000,000 |
Term Loans - Aggregate annual p
Term Loans - Aggregate annual payments due on Term Loan (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Aggregate annual payments due on Term Loan | ||
2027 | $ 30,000 | |
Total future payments | 30,000 | |
Add: PIK interest | 1,219 | |
Less: unamortized debt discount | (288) | $ (361) |
Total term loan, net of discount | $ 30,931 |
Income Taxes - Canadian Income
Income Taxes - Canadian Income Tax Rate Reconciliation (Details) - Canada Revenue Agency - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Domestic loss | $ (12,301) | $ (10,548) |
Foreign loss | (3,744) | (13,117) |
Loss before income taxes | $ (16,045) | $ (23,665) |
Income Tax Expense (Benefit) Reconciliation | ||
Expected statutory rate | 26.50% | 26.50% |
Expected provision for (recovery of) income tax | $ (4,252) | $ (6,271) |
Permanent differences | 1,553 | 1,170 |
Change in valuation allowance | 2,038 | 4,669 |
Effect of tax rate changes and other | 661 | 432 |
Provision for income taxes | $ 0 | $ 0 |
Income Taxes - Income Tax Rates
Income Taxes - Income Tax Rates (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2018 | |
Internal Revenue Service | |||
Operating Loss Carryforwards [Line Items] | |||
Corporate tax rate prior-to The Tax Cuts and Jobs Act | 34% | ||
Corporate tax rate under The Tax Cuts and Jobs Act | 21% | ||
Canada Revenue Agency | |||
Operating Loss Carryforwards [Line Items] | |||
Effective income tax rate | 26.50% | 26.50% | |
Federal income tax rate | 15% | ||
Provincial tax rate | 11.50% |
Income Taxes - Future Income Ta
Income Taxes - Future Income Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Taxes | ||
SR&ED expenditures | $ 2,086 | $ 2,086 |
Income tax loss carryforwards | 37,143 | 30,007 |
Non-refundable investment tax credits | 297 | 700 |
Share issue costs | 73 | 77 |
Fixed and intangible assets | 1,083 | 1,083 |
Debt discount | 62 | 0 |
Gross future tax assets | 40,744 | 33,953 |
Less: valuation allowance | (40,718) | (33,927) |
Net future tax assets | $ 26 | $ 26 |
Income Taxes - Tax Loss Carry-F
Income Taxes - Tax Loss Carry-Forwards And Non-Refundable Investment Tax Credits (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Federal | SR&ED Expenditures | No Expiration | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | $ 7,872 |
Federal | Income Tax Loss Carryforwards | 2024 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 4,849 |
Federal | Income Tax Loss Carryforwards | 2025 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 6,143 |
Federal | Income Tax Loss Carryforwards | 2026 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 13,868 |
Federal | Income Tax Loss Carryforwards | 2027 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 8,136 |
Federal | Income Tax Loss Carryforwards | 2028 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 10,509 |
Federal | Income Tax Loss Carryforwards | 2029 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 8,185 |
Federal | Income Tax Loss Carryforwards | 2030 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 2,608 |
Federal | Income Tax Loss Carryforwards | 2031 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 3,378 |
Federal | Income Tax Loss Carryforwards | 2032 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 3,491 |
Federal | Income Tax Loss Carryforwards | 2033 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 1,789 |
Federal | Income Tax Loss Carryforwards | 2034 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 1,812 |
Federal | Income Tax Loss Carryforwards | 2035 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 1,803 |
Federal | Income Tax Loss Carryforwards | 2036 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 2,208 |
Federal | Income Tax Loss Carryforwards | 2037 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 4,641 |
Federal | Income Tax Loss Carryforwards | 2038 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 7,427 |
Federal | Income Tax Loss Carryforwards | 2039 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 9,587 |
Federal | Income Tax Loss Carryforwards | 2040 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 15,009 |
Federal | Income Tax Loss Carryforwards | 2041 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 13,556 |
Federal | Income Tax Loss Carryforwards | 2042 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 18,798 |
Federal | Income Tax Loss Carryforwards | No Expiration | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 37,204 |
Federal | Investment Tax Credits | 2024 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 189 |
Federal | Investment Tax Credits | 2025 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 82 |
Federal | Investment Tax Credits | 2026 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 86 |
Federal | Investment Tax Credits | 2027 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 47 |
Province / State | SR&ED Expenditures | No Expiration | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2024 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2025 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2026 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2027 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2028 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2029 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 2,116 |
Province / State | Income Tax Loss Carryforwards | 2030 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 700 |
Province / State | Income Tax Loss Carryforwards | 2031 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 789 |
Province / State | Income Tax Loss Carryforwards | 2032 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 651 |
Province / State | Income Tax Loss Carryforwards | 2033 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 655 |
Province / State | Income Tax Loss Carryforwards | 2034 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 617 |
Province / State | Income Tax Loss Carryforwards | 2035 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 941 |
Province / State | Income Tax Loss Carryforwards | 2036 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 1,013 |
Province / State | Income Tax Loss Carryforwards | 2037 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 1,638 |
Province / State | Income Tax Loss Carryforwards | 2038 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2039 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2040 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2041 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | 2042 | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | 0 |
Province / State | Income Tax Loss Carryforwards | No Expiration | |
Tax Credit Carryforward [Line Items] | |
Income tax carryforwards | $ 24,837 |
Revision to Prior Period Fina_3
Revision to Prior Period Financial Statements - Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Reclassification [Line Items] | ||||
Prepaid expenses | $ 2,575 | $ 1,197 | $ 770 | |
Total current assets | 26,858 | 19,896 | 26,728 | |
Total Assets | 26,864 | 19,978 | 26,939 | |
Accumulated Deficit | 219,245 | (215,613) | 203,200 | |
Total stockholders' deficit | 11,622 | (9,581) | 2,569 | $ (15,772) |
Total liabilities and stockholders' deficit | $ (26,864) | (19,978) | $ (26,939) | |
As Previously Reported | ||||
Reclassification [Line Items] | ||||
Prepaid expenses | 247 | |||
Total current assets | 18,946 | |||
Total Assets | 19,028 | |||
Accumulated Deficit | (216,563) | |||
Total stockholders' deficit | (10,531) | |||
Total liabilities and stockholders' deficit | (19,028) | |||
Adjustments | ||||
Reclassification [Line Items] | ||||
Prepaid expenses | 950 | |||
Total current assets | 950 | |||
Total Assets | 950 | |||
Accumulated Deficit | (950) | |||
Total stockholders' deficit | (950) | |||
Total liabilities and stockholders' deficit | $ (950) |
Revisions to Prior Period Finan
Revisions to Prior Period Financial Statements - Condensed Consolidated Statement of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Reclassification [Line Items] | ||||
PEDMARK, product sales, net | $ 6,296 | $ 11,298 | $ 21,252 | $ 1,535 |
Operating expenses: | ||||
Sales and marketing expense | (2,215) | (7,086) | ||
Net loss | (917) | (12,413) | $ 16,045 | $ 23,714 |
Net loss attributable to common shareholders | $ (917) | $ (12,413) | ||
Basic net loss per common share | $ (0.03) | $ (0.47) | $ (0.60) | $ (0.90) |
Diluted net loss per common share | $ (0.03) | $ (0.47) | $ (0.60) | $ (0.90) |
As Previously Reported | ||||
Reclassification [Line Items] | ||||
PEDMARK, product sales, net | $ 6,515 | $ 11,517 | ||
Operating expenses: | ||||
Sales and marketing expense | (3,384) | (8,255) | ||
Net loss | (1,867) | (13,363) | ||
Net loss attributable to common shareholders | $ (1,867) | $ (13,363) | ||
Basic net loss per common share | $ (0.07) | $ (0.50) | ||
Diluted net loss per common share | $ (0.07) | $ (0.50) | ||
Adjustments | ||||
Reclassification [Line Items] | ||||
PEDMARK, product sales, net | $ (219) | $ (219) | ||
Operating expenses: | ||||
Sales and marketing expense | 1,169 | 1,169 | ||
Net loss | 950 | 950 | ||
Net loss attributable to common shareholders | $ 950 | $ 950 | ||
Basic net loss per common share | $ 0.04 | $ 0.03 | ||
Diluted net loss per common share | $ 0.04 | $ 0.03 |
Revisions to Prior Period Fin_2
Revisions to Prior Period Financial Statements - Condensed Consolidated Statement of Stockholders' Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Reclassification [Line Items] | ||||
Net loss | $ (16,045) | $ (23,714) | ||
Balance | $ 9,581 | $ 9,581 | (11,622) | (2,569) |
Accumulated Deficit | ||||
Reclassification [Line Items] | ||||
Net loss | (12,413) | (16,045) | (23,714) | |
Balance | (215,613) | (215,613) | $ (219,245) | $ (203,200) |
Accumulated Deficit | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | (917) | |||
Balance | (215,613) | (215,613) | ||
Total Stockholders' Equity | ||||
Reclassification [Line Items] | ||||
Net loss | (12,413) | |||
Balance | (9,581) | (9,581) | ||
Total Stockholders' Equity | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | (917) | |||
Balance | (9,581) | (9,581) | ||
As Previously Reported | ||||
Reclassification [Line Items] | ||||
Balance | 10,531 | 10,531 | ||
As Previously Reported | Accumulated Deficit | ||||
Reclassification [Line Items] | ||||
Net loss | (13,363) | |||
Balance | (216,563) | (216,563) | ||
As Previously Reported | Accumulated Deficit | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | (1,867) | |||
Balance | (216,563) | (216,563) | ||
As Previously Reported | Total Stockholders' Equity | ||||
Reclassification [Line Items] | ||||
Net loss | (13,363) | |||
Balance | (10,531) | (10,531) | ||
As Previously Reported | Total Stockholders' Equity | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | (1,867) | |||
Balance | (10,531) | (10,531) | ||
Adjustments | ||||
Reclassification [Line Items] | ||||
Balance | 950 | 950 | ||
Adjustments | Accumulated Deficit | ||||
Reclassification [Line Items] | ||||
Net loss | 950 | |||
Adjustments | Accumulated Deficit | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | 950 | |||
Adjustments | Total Stockholders' Equity | ||||
Reclassification [Line Items] | ||||
Net loss | $ 950 | |||
Adjustments | Total Stockholders' Equity | Three Months Ended | ||||
Reclassification [Line Items] | ||||
Net loss | $ 950 |
Revisions to Prior Period Fin_3
Revisions to Prior Period Financial Statements - Condensed Consolidated Statement of Cash Flows (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows from Operating Activities: | |||
Net loss | $ (12,413) | $ 16,045 | $ 23,714 |
Changes in operating assets and liabilities: | |||
Prepaid expenses | (427) | 104 | 264 |
Subtotal of non-cash charges | 130 | ||
Net cash used in operating activities | (12,283) | $ (17,143) | $ (18,058) |
As Previously Reported | |||
Cash Flows from Operating Activities: | |||
Net loss | (13,363) | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses | 523 | ||
Subtotal of non-cash charges | 1,080 | ||
Net cash used in operating activities | (12,283) | ||
Adjustments | |||
Cash Flows from Operating Activities: | |||
Net loss | 950 | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses | (950) | ||
Subtotal of non-cash charges | $ (950) |
Revisions to Prior Period Fin_4
Revisions to Prior Period Financial Statements - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Revision to Prior Period Financial Statements | |
Net product sales adjustment | $ (0.2) |
Sales and marketing expense adjustment | (1.2) |
Current assets adjustment | $ 1 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - Licensing Agreement - Norgine Ltd. $ in Millions | Mar. 17, 2024 USD ($) |
License agreement funding received | $ 43 |
License agreement funding, potential milestone payments | $ 230 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ 917 | $ 12,413 | $ (16,045) | $ (23,714) |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | Insider Adoption or Termination of Trading Arrangements During the fiscal quarter ended December 31, 2023, Rostislav Raykov |
Name | Rostislav Raykov |
Title | Chief Executive Officer, Director |
Rule 10b5-1 Arrangement Adopted | true |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Termination Date | December 13, 2024 |
Aggregate Available | 133,000 |