FENNEC PHARMACEUTICALS INC. 10-Q

Item 1. Financial Statements Fennec Pharmaceuticals Inc. Condensed Consolidated Balance Sheets (U.S. Dollars and shares in thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, ​ ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets ​ ​ ​ Current assets ​ ​ ​ Cash and cash equivalents ​ $ 12,399 ​ $ 23,774 ​ Accounts receivable, net ​ ​ 4,525 ​ ​ 1,545 ​ Prepaid expenses ​ 247 ​ 770 ​ Inventory ​ ​ 1,755 ​ ​ 576 ​ Other current assets ​ 20 ​ 63 ​ Total current assets ​ ​ 18,946 ​ ​ 26,728 ​ ​ ​ ​ ​ ​ ​ ​ ​ Non-current assets ​ ​ ​ ​ ​ ​ ​ ROU asset non-current ​ ​ 29 ​ ​ — ​ Deferred issuance costs, net of amortization ​ ​ 53 ​ ​ 211 ​ Total non-current assets ​ ​ 82 ​ ​ 211 ​ Total assets ​ $ 19,028 ​ $ 26,939 ​ ​ ​ ​ ​ Liabilities and stockholders’ deficit ​ ​ ​ Current liabilities: ​ ​ ​ Accounts payable ​ $ 2,941 ​ $ 2,390 ​ Accrued liabilities ​ 951 ​ 2,219 ​ Operating lease liability - current ​ ​ 21 ​ ​ — ​ Total current liabilities ​ 3,913 ​ 4,609 ​ ​ ​ ​ ​ ​ ​ ​ ​ Non-current liabilities ​ ​ ​ ​ ​ ​ ​ Term loan ​ ​ 25,000 ​ ​ 25,000 ​ PIK interest ​ ​ 937 ​ ​ 260 ​ Debt discount ​ ​ ( 298 ) ​ ​ ( 361 ) ​ Operating lease liability - net of current portion ​ ​ 7 ​ ​ — ​ Total non-current liabilities ​ ​ 25,646 ​ ​ 24,899 ​ Total liabilities ​ 29,559 ​ 29,508 ​ ​ ​ ​ ​ Commitments and contingencies (Note 6) ​ ​ ​ ​ ​ ​ ​ Stockholders’ deficit: ​ ​ ​ Common stock, no par value; unlimited shares authorized; 26,635 shares issued and outstanding (2022 ‑ 26,361 ) ​ 143,560 ​ 142,591 ​ Additional paid-in capital ​ 61,229 ​ 56,797 ​ Accumulated deficit ​ ( 216,563 ) ​ ( 203,200 ) ​ Accumulated other comprehensive income ​ 1,243 ​ 1,243 ​ Total stockholders’ deficit ​ ( 10,531 ) ​ ( 2,569 ) ​ Total liabilities and holders’ deficit ​ $ 19,028 ​ $ 26,939 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 3 Table of Contents Fennec Pharmaceuticals Inc. Condensed Consolidated Statements of Operations (U.S. Dollars and shares in thousands, except per share amounts) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ September 30, ​ September 30, ​ September 30, ​ September 30, ​ 2023 2022 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ PEDMARK® product sales, net ​ $ 6,515 ​ $ — ​ $ 11,517 ​ $ — Cost of products sold ​ ​ ( 331 ) ​ ​ — ​ ​ ( 574 ) ​ ​ — Gross profit ​ ​ 6,184 ​ ​ — ​ ​ 10,943 ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses: ​ ​ ​ ​ Research and development ​ 12 ​ 846 ​ 24 ​ 3,414 Selling and marketing ​ ​ 3,384 ​ ​ — ​ ​ 8,255 ​ ​ — General and administrative ​ 3,805 ​ 7,053 ​ 13,617 ​ 13,040 ​ ​ ​ ​ ​ Total operating expenses ​ 7,201 ​ 7,899 ​ 21,896 ​ 16,454 Loss from operations ​ ​ ( 1,017 ) ​ ​ ( 7,899 ) ​ ​ ( 10,953 ) ​ ​ ( 16,454 ) ​ ​ ​ ​ ​ Other (expense)/income ​ ​ ​ ​ Realized foreign exchange (loss)/gain ​ ​ ( 11 ) ​ ​ ( 4 ) ​ ​ 3 ​ ​ ( 6 ) Amortization expense ​ ​ ( 72 ) ​ ​ ( 64 ) ​ ​ ( 217 ) ​ ​ ( 79 ) Unrealized loss on securities ​ ( 13 ) ​ ​ ( 27 ) ​ ​ ( 43 ) ​ ​ ( 126 ) Interest income ​ 102 ​ ​ 24 ​ ​ 326 ​ ​ 42 Interest expense ​ ​ ( 856 ) ​ ​ ( 119 ) ​ ​ ( 2,479 ) ​ ​ ( 234 ) Total other expense ​ ( 850 ) ​ ( 190 ) ​ ( 2,410 ) ​ ( 403 ) Net loss ​ $ ( 1,867 ) ​ $ ( 8,089 ) ​ $ ( 13,363 ) ​ $ ( 16,857 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic net loss per common share ​ $ ( 0.07 ) ​ $ ( 0.31 ) ​ $ ( 0.50 ) ​ $ ( 0.65 ) Diluted net loss per common share ​ $ ( 0.07 ) ​ $ ( 0.31 ) ​ $ ( 0.50 ) ​ $ ( 0.65 ) Weighted-average number of common shares outstanding basic ​ ​ 26,596 ​ ​ 26,108 ​ ​ 26,523 ​ ​ 26,105 Weighted-average number of common shares outstanding diluted ​ 26,596 ​ 26,108 ​ ​ 26,523 ​ ​ 26,105 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 4 Table of Contents ​ Fennec Pharmaceuticals Inc. Condensed Consolidated Statements of Stockholders’ Equity Three and Nine Months Ended September 30, 2023, and 2022 (U.S. dollars and shares in thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ Other ​ Total ​ ​ Common Stock ​ Paid-in ​ Accumulated ​ Comprehensive ​ Stockholders’ ​ Shares Amount Capital Deficit Income Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2022 ​ 26,361 ​ $ 142,591 ​ $ 56,797 ​ $ ( 203,200 ) ​ $ 1,243 ​ $ ( 2,569 ) Stock-based compensation - employees — ​ ​ — ​ ​ 1,089 ​ — ​ — ​ 1,089 Stock option exercise ​ 49 ​ ​ 213 ​ ​ — ​ ​ — ​ ​ — ​ ​ 213 Restricted stock release ​ 1 ​ ​ — ​ ​ ( 20 ) ​ ​ — ​ ​ — ​ ​ ( 20 ) Net loss — ​ — ​ — ​ ( 6,052 ) ​ — ​ ( 6,052 ) Balance at March 31, 2023 26,411 ​ ​ 142,804 ​ ​ 57,866 ​ ​ ( 209,252 ) ​ ​ 1,243 ​ ​ ( 7,339 ) Stock-based compensation - employees ​ — ​ ​ — ​ ​ 2,543 ​ ​ — ​ ​ — ​ ​ 2,543 Stock option exercise ​ 95 ​ ​ 541 ​ ​ — ​ ​ — ​ ​ — ​ ​ 541 Restricted stock release ​ 3 ​ ​ — ​ ​ ( 28 ) ​ ​ — ​ ​ — ​ ​ ( 28 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 5,444 ) ​ ​ — ​ ​ ( 5,444 ) Balance at June 30, 2023 ​ 26,509 ​ ​ 143,345 ​ ​ 60,381 ​ ​ ( 214,696 ) ​ ​ 1,243 ​ ​ ( 9,727 ) Stock-based compensation - employees ​ — ​ ​ — ​ ​ 865 ​ ​ — ​ ​ — ​ ​ 865 Stock option exercise ​ 92 ​ ​ 215 ​ ​ — ​ ​ — ​ ​ — ​ ​ 215 Restricted stock release ​ 32 ​ ​ — ​ ​ ( 17 ) ​ ​ — ​ ​ — ​ ​ ( 17 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 1,867 ) ​ ​ — ​ ​ ( 1,867 ) Balance at September 30, 2023 ​ 26,633 ​ $ 143,560 ​ $ 61,229 ​ $ ( 216,563 ) ​ $ 1,243 ​ $ ( 10,531 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ Other ​ Total ​ ​ Common Stock ​ Paid-in ​ Accumulated ​ Comprehensive ​ Stockholders’ ​ ​ Shares Amount Capital Deficit Income Equity Balance at December 31, 2021 ​ 26,014 ​ $ 140,801 ​ $ 53,214 ​ $ ( 179,486 ) ​ $ 1,243 ​ $ 15,772 Stock-based compensation - employees — ​ — ​ 399 ​ ​ — ​ ​ — ​ ​ 399 Stock-based compensation - consultants — ​ — ​ 34 ​ — ​ — ​ 34 Stock option exercise ​ 26 ​ ​ 31 ​ ​ ( 16 ) ​ ​ — ​ ​ — ​ ​ 15 Restricted stock release ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 3,696 ) ​ ​ — ​ ​ ( 3,696 ) Balance at March 31, 2022 26,040 ​ ​ 140,832 ​ ​ 53,631 ​ ​ ( 183,182 ) ​ ​ 1,243 ​ ​ 12,524 Stock-based compensation - employees ​ — ​ ​ — ​ ​ 1,008 ​ ​ — ​ ​ — ​ ​ 1,008 Stock-based compensation - consultants ​ — ​ ​ — ​ ​ 35 ​ ​ — ​ ​ — ​ ​ 35 Stock option exercise ​ 19 ​ ​ 90 ​ ​ ( 44 ) ​ ​ — ​ ​ — ​ ​ 46 Restricted stock release ​ 8 ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 5,072 ) ​ ​ — ​ ​ ( 5,072 ) Balance at June 30, 2022 ​ 26,067 ​ ​ 140,922 ​ ​ 54,630 ​ ​ ( 188,254 ) ​ ​ 1,243 ​ ​ 8,541 Stock-based compensation - employees ​ — ​ ​ — ​ ​ 1,853 ​ ​ — ​ ​ — ​ ​ 1,853 Stock-based compensation - consultants ​ — ​ ​ — ​ ​ 34 ​ ​ — ​ ​ — ​ ​ 34 Warrants issued to creditor ​ — ​ ​ — ​ ​ 441 ​ ​ — ​ ​ — ​ ​ 441 Stock option exercise ​ 151 ​ ​ 387 ​ ​ ( 199 ) ​ ​ — ​ ​ — ​ ​ 188 Restricted stock release ​ 20 ​ ​ — ​ ​ ( 166 ) ​ ​ — ​ ​ — ​ ​ ( 166 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 8,089 ) ​ ​ — ​ ​ ( 8,089 ) Balance at September 30, 2022 ​ 26,238 ​ $ 141,309 ​ $ 56,593 ​ $ ( 196,343 ) ​ $ 1,243 ​ $ 2,802 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 5 Table of Contents ​ Fennec Pharmaceuticals Inc. Condensed Consolidated Statements of Cash Flows (U.S. Dollars in thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended ​ ​ ​ September 30, ​ September 30, ​ ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ Cash flows (used in) provided by: ​ ​ ​ Operating activities: ​ ​ ​ Net loss ​ $ ( 13,363 ) ​ $ ( 16,857 ) ​ Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ ​ ​ Amortization of debt access fees ​ 166 ​ 77 ​ Amortization of debt discount ​ ​ 51 ​ ​ 2 ​ Unrealized loss on securities ​ ​ 43 ​ ​ 126 ​ Stock-based compensation - consultants ​ — ​ 103 ​ Stock-based compensation - employees ​ 4,497 ​ 3,260 ​ Changes in operating assets and liabilities: ​ ​ ​ ​ ​ Accounts receivable ​ ​ ( 2,980 ) ​ ​ — ​ Prepaid expenses ​ 523 ​ 756 ​ Inventory ​ ​ ( 1,179 ) ​ ​ — ​ Other assets ​ — ​ 4 ​ Accounts payable ​ 551 ​ 1,756 ​ Accrued liabilities and PIK interest ​ ( 592 ) ​ ( 483 ) ​ Net cash used in operating activities ​ ( 12,283 ) ​ ( 11,256 ) ​ ​ ​ ​ ​ Financing activities: ​ ​ ​ Long-term debt ​ ​ — ​ ​ 25,000 ​ Long-term debt paid ​ ​ — ​ ​ ( 5,000 ) ​ Issuance of shares, options exercise ​ 969 ​ 249 ​ Cash paid for taxes on restricted share release ​ ​ ( 61 ) ​ ​ ( 166 ) ​ Capitalized deferred issuance costs ​ — ​ ( 175 ) ​ Net cash provided by financing activities ​ 908 ​ 19,908 ​ ​ ​ ​ ​ ​ ​ ​ ​ Increase/(decrease) in cash and cash equivalents ​ ​ ( 11,375 ) ​ ​ 8,652 ​ Cash and cash equivalents - Beginning of period ​ ​ 23,774 ​ ​ 21,100 ​ Cash and cash equivalents - End of period ​ $ 12,399 ​ $ 29,752 ​ ​ ​ ​ ​ ​ ​ ​ ​ Non-cash investing and financing activities: ​ ​ ​ Capitalized lease asset ​ $ 29 ​ $ — ​ Warrants issued for long-term debt ​ $ — ​ $ 441 ​ ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statement. ​ ​ ​ ​ ​ ​ ​ ​ ​ 6 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ 1. Nature of Business and Going Concern ​ Fennec Pharmaceuticals Inc., a corporation existing under the laws of British Columbia (“Fennec,” the “Company,” “we,” “us,” or “our”), was originally formed under the name Adherex Technologies Inc. and subsequently changed its name on September 3, 2014. Fennec is a commercial stage specialty pharmaceutical company with one U.S. Food and Drug Administration (“FDA”) approved and European Commission approved product , PEDMARK ® , 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. The Company has four wholly owned subsidiaries: Oxiquant, Inc. (“Oxiquant”) and Fennec Pharmaceuticals, Inc., both Delaware corporations, Cadherin Biomedical Inc. (“CBI”), a Canadian corporation, and Fennec Pharmaceuticals (EU) Limited (“Fennec Limited”), an Ireland company, collectively referred to herein as the “Company.” With the exception of Fennec Pharmaceuticals, Inc. and Fennec Pharmaceuticals (EU) all subsidiaries are inactive. These unaudited interim condensed 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 three and nine months ended September 30, 2023, the Company incurred a loss from operations of $ 1,017 and $ 10,953 , respectively. At September 30, 2023, it had an accumulated deficit of $ 216,563 and had experienced negative cash flows from operating activities during the nine months ended September 30, 2023, in the amount of $ 12,283 . 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 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 SPA. 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 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®. ​ Subsequent to the funding of the Second Closing Note, and before December 31, 2023, the Company may draw up to $ 20,000 of additional financing under the SPA, in one or more tranches of $ 10,000 upon mutual agreement of the Company and the Investor (the “Subsequent Closing Notes”). The Subsequent Closing Notes will be convertible at a price per share equal to $ 7.89 per share, which price is calculated on the same basis as for the Second Closing Note. ​ A commitment fee of 2.0 % of the Notes was payable under the SPA. Half of such fee was paid by the issuance on the first closing of warrants to purchase approximately 0.05 Fennec common shares (“First Closing Warrant”) and half was payable in cash or warrants of approximately 0.05 Fennec common shares (“Second Closing Warrant”), at the Company’s election, on the second closing. The warrants are exercisable at a price per share of $ 8.11 and will have a term of five years from the date of the grant. The Company elected to have all the commitment fee of the Notes payable in warrants. ​ The Company believes current funds, which include funds from the First Closing Note and the Second Closing Note, provide sufficient funding for the Company to carry out its planned activities, including the continuation of commercialization efforts of PEDMARK ® in the United States and preparation for commercialization of PEDMARK ® outside of the United States, for at least the next twelve months. ​ ​ 7 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ 2. Significant Accounting Policies Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with US GAAP and are the responsibility of the Company’s management. These unaudited interim condensed consolidated financial statements do not include all of the information and notes required by US GAAP for annual financial statements. Accordingly, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited condensed consolidated financial statements and notes filed with the Securities and Exchange Commission (“SEC”) in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The Company’s accounting policies are consistent with those presented in the audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2022. These unaudited interim condensed consolidated financial statements have been prepared in U.S. dollars. All amounts presented are in thousands except for per share amounts. The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of results to be expected for the full fiscal year. 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 product sales discounts and allowances, allowance against trade receivables, measurement of stock-based compensation and estimates of the Company’s capital requirement 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 September 30, 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 Company’s stock-based compensation programs, the Company periodically grants stock options and restricted stock units to employees, directors, and consultants. The fair value of each award is recognized in the Company’s statements of operations over the requisite service period for such award. ​ The Company uses the Black-Scholes option pricing model to value stock option awards without market conditions, which requires the Company to make certain assumptions regarding the expected volatility of its common stock price, the expected term of the option grants, the risk-free interest rate and the dividend yield with respect to its common stock. The Company calculates volatility using its historical stock price data. Due to the lack of the Company’s own historical data, the Company elected to use the “simplified” method for “plain vanilla” options to estimate the expected term of the Company’s stock option grants. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option. The risk-free interest rate used for each grant is based on the United States Treasury yield curve in effect at the time of grant for instruments with a similar expected life. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and, at present, has no intention to pay cash dividends. 8 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ 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, 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 the 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 ® prior to regulatory approval were not capitalized as inventory but were expensed as research and development costs. The Company expensed pre-launch inventory as it could not reasonably anticipate FDA approval of 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 and estimating the amount of variable consideration to include in the transaction price. Net Product Revenue On September 20, 2022, the FDA approved PEDMARK ® in the United States to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. PEDMARK ® became commercially available in the United States on October 17, 2022. PEDMARK ® is the Company’s first commercial product. The Company sells its product through the following specialty distributors: Amerisource Specialty Distribution (“ASD”), McKesson Plasma and Biologics, McKesson Specialty, and Cardinal Health Specialty (collectively the “Customers” and each a “Customer”). Further, the Company sells directly to other customers without the use of specialty distributors. These Customers subsequently resell the Company’s products to health care providers and patients. In addition to distribution agreements with Customers, the Company enters arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. The amount of revenue recognized is net of these discounts in an amount equal to the cash expected to be collected. Product Sales Discounts and Allowances The Company records 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 ® is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it 9 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known. Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty distributor. Contracted customers, which currently consist of Public Health Service institutions and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers. Discounts for Prompt Payment: Customers receive a discount of 0.65 % for prompt payment. The Company expects its Customers will earn 100 % of their prompt payment discounts and, therefore, the Company deducts the full amount of these discounts from total product sales when revenues are recognized. Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and other government programs. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. The Company’s estimates for the expected utilization of rebates are based on Customer and payor data received from the specialty distributors and historical utilization rates that will develop over time, as PEDMARK ® is the Company’s first commercial product. Rebates are generally invoiced by the payor and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to the Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenues in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the third party that administers the copay program. If actual program redemption varies from estimates, the Company may need to adjust its accruals, which would affect net product revenues in the period of adjustment. Other Customer Credits: The Company pays fees to certain of its Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to its Customers, the Company classifies these payments in selling and marketing, general and administrative expenses in its Condensed Consolidated Statements of Operations. The following table summarizes net product revenues for PEDMARK ® in the United States and abroad earned during the three and nine months ended September 30, 2023 and 2022, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ ​ ​ September 30, ​ ​ September 30, ​ ​ September 30, ​ ​ September 30, In thousands ​ ​ ​ 2023 ​ ​ 2022 ​ ​ 2023 ​ ​ 2022 Product revenues: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Gross product revenues ​ ​ $ 6,919 ​ $ — ​ $ 12,525 ​ $ — Discounts and allowances ​ ​ ​ ( 404 ) ​ ​ — ​ ​ ( 1,008 ) ​ ​ — Net product revenues ​ ​ $ 6,515 ​ $ — ​ $ 11,517 ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ The following table summarizes the percentage of total product revenues for PEDMARK ® in the United States and abroad by Customers who individually accounted for 10 % or more of total product revenues earned in the three and nine months ended September 30, 2023, and 2022, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ September 30, ​ September 30, ​ ​ September 30, ​ September 30, Specialty Distributors ​ 2023 ​ 2022 ​ ​ 2023 ​ 2022 ASD ​ 16 % — % ​ 24 % — McKesson ​ 19 ​ — ​ ​ 16 ​ — Subtotal-Specialty Distributors ​ 35 ​ — ​ ​ 40 ​ — Direct Customers ​ 65 ​ — ​ ​ 60 ​ — ​ ​ 100 % — % ​ 100 % — ​ The activities and ending allowance balances for each significant category of discounts and allowances for PEDMARK ® (which constitute variable consideration) for the nine months ended September 30, 2023, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Chargebacks, ​ Rebates, Customer ​ ​ ​ ​ ​ Discounts for ​ Fees/Credits ​ ​ ​ ​ ​ Prompt pay and ​ and Co-Pay ​ ​ ​ In thousands ​ Other allowances ​ Assistance ​ Totals Balance at December 31, 2022 ​ $ 71 ​ $ 163 ​ $ 234 Provision related to sales made in: ​ ​ ​ ​ ​ ​ ​ ​ ​ Current period ​ 116 ​ ​ 117 ​ ​ 233 Prior periods ​ ​ — ​ ​ — ​ ​ — Payments and customer credits issued ​ ​ ( 31 ) ​ ​ ( 66 ) ​ ​ ( 97 ) Balance at March 31, 2023 ​ $ 156 ​ $ 214 ​ $ 370 Provision related to sales made in: ​ ​ 246 ​ ​ 148 ​ ​ 394 Current period ​ ​ — ​ ​ — ​ ​ — Prior periods ​ ​ — ​ ​ — ​ ​ — Payments and customer credits issued ​ ​ ( 193 ) ​ ​ ( 124 ) ​ ​ ( 317 ) Balance at June 30, 2023 ​ $ 209 ​ $ 238 ​ $ 447 Provision related to sales made in: ​ ​ ​ ​ ​ ​ ​ ​ ​ Current period ​ 334 ​ ​ 180 ​ ​ 514 Prior periods ​ ​ — ​ ​ — ​ ​ — Payments and customer credits issued ​ ​ ( 307 ) ​ ​ ( 71 ) ​ ​ ( 378 ) Balance at September 30, 2023 ​ $ 236 ​ $ 347 ​ $ 583 ​ 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 Condensed Consolidated Balance Sheets. Trade Receivables The Company records gross trade receivables at the time of product sale to its Customers. Amounts estimated for the associated chargebacks, cash discounts for prompt payment and any allowances for credit losses are booked as a reserve against accounts receivable and reduction of revenue. The Company determines its allowance methodology by pooling receivable balances at the Customer level. The Company considers various factors, including loss history, individual credit risk associated to each Customer, and the current and future condition of the general economy. These credit risk factors are monitored on a quarterly basis and updated as necessary. To the extent that any individual debtor is identified whose credit quality has deteriorated, the Company establishes allowances based on the individual risk 11 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ characteristics of such a Customer. The Customers are mainly specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low. It is the policy of the Company to reserve 1% of its net sales to non-specialty distributors, as such the Company had an immaterial balance in allowance for doubtful accounts as of September 30, 2023. ​ Cost of Products Sold Cost of products sold is related to the Company's product revenues for PEDMARK ® and consists primarily of product production costs associated with finished goods inventory and royalties ( 1 % of net sales) the Company is required to pay to Oregon Health & Science University (“OHSU”) on all net sales of PEDMARK ® . The cost of products sold also consists of shipping and other third party logistics and distribution costs for PEDMARK ® . The Company considered regulatory approval of PEDMARK ® to be uncertain and product manufactured prior to regulatory approval could not have been sold unless regulatory approval was obtained. As such, the manufacturing costs for PEDMARK ® incurred prior to regulatory approval were not capitalized as inventory but were expensed as research and development costs. After FDA approval in September 2022, the Company had various lots of PEDMARK ® in various stages of production in connection with the product launch. As of September 30, 2023, the Company capitalized approximately $ 1.8 million of costs as inventory on the Condensed Consolidated Balance Sheet. Of the items capitalized, $ 0.1 million was capitalized as raw materials, $ 0.9 million was capitalized as work in process, $ 0.8 million was capitalized into finished goods, with $ 0.6 million being reclassified to cost of products sold. 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. At September 30, 2023, the Company had $ 12,399 in cash, savings and money market accounts ($ 23,774 at December 31, 2022). At September 30, 2023, the Company held $ 2,007 in cash of which $ 488 (as presented in U.S. dollars) was in Canadian dollars ($ 34 at December 31, 2022 as presented in U.S. dollars). At September 30, 2023, the Company held $ 10,392 in money market investments. 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 amount insured by the FDIC and may lose value. Financial Instruments Financial instruments recognized on the balance sheets at September 30, 2023 and December 31, 2022 consist of cash and cash equivalents, accounts receivable, accounts payable 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. 12 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ The policy risks are primarily the opportunity cost of the conservative nature of the allowable investments. Until the company is cash flow positive from operations, the Company has chosen to avoid investments of a trading or speculative nature. 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 accounts receivable. The Company maintains deposits in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s trade receivables include amounts billed to Customers for product sales of PEDMARK ® . The Customers are a limited group of specialty distributors and select customers abroad, with substantial financial resources, and accordingly, the Company considers the risk of potential credit losses to be low. 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 September 30, 2023, we maintained a full valuation allowance against our deferred tax assets. The provisions of the 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, the Company 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 Transactions The U.S. dollar is the functional currency for the Company’s consolidated operations. All gains and losses from currency transactions are included in results of operations. New Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, “Measurement of Credit Losses on Financial Instruments.” This ASU replaces the incurred loss impairment methodology in current US GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information for credit loss estimates on certain types of financial instruments, including trade receivables. In addition, new disclosures are required. The ASU, as subsequently amended, is effective for the Company for fiscal years 13 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ beginning after December 15, 2022, as the Company is a smaller reporting company as defined in Item 10(f)(1) of Regulation S-K. We adopted ASU 2016-13 on January 1, 2023. Based on the composition of the Company’s accounts receivable, the adoption of this standard did not have a material impact on the Company’s consolidated financial statements or disclosures. Specifically, the Company’s estimate of expected credit losses as of September 30, 2023, using its expected credit loss evaluation process, resulted in no adjustments to the provision for credit losses and no cumulative effect adjustment to accumulated deficit on the adoption date of the standard. ​ In July 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-03 to amend various SEC paragraphs in the Accounting Standards Codification to primarily reflect the issuance of SEC Staff Accounting Bulletin No. 120. ASU No. 2023-03, “Presentation of Financial Statements (Topic 205), Income Statement-Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation-Stock Compensation (Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280-General Revision of Regulation S-X: Income or Loss Applicable to Common Stock.” ASU 2023-03 amends the ASC for SEC updates pursuant to SEC Staff Accounting Bulletin No. 120; SEC Staff Announcement at the March 24, 2022 Emerging Issues Task Force (“EITF”) Meeting; and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 - General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. These updates were immediately effective and did not have a material impact on our financial statements. ​ In October 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-06 to amend various SEC paragraphs in the Accounting Standards Codification to primarily reflect SEC Release No. 33-10532, Disclosure Update and Simplification. ASU 2023-06 amends disclosure guidance over an entity’s accounting policy related to derivative instruments, material prior period adjustments upon a change in a reporting entity, earnings-per-share, encumbered assets, unused lines of credit and unfunded commitments, and liquidation preferences of preferred stock. The amendments are effective prospectively on the date each individual amendment is effectively removed from Regulation S-X or Regulation S-K. ​ 3. 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, 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 and options to purchase 5.0 million of our common shares at September 30, 2023, were not included in loss per share. Such instruments would have an antidilutive effect. During the same period in 2022, warrants to purchase 0.04 million of our common shares and options to purchase 4.3 million common shares were excluded from the computation of loss per share as their inclusion would have been anti dilutive ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The following outstanding options 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended September 30, ​ ​ 2023 2022 Options to purchase common shares 5,005 ​ 4,466 Warrants to purchase common shares 150 ​ 150 ​ ​ ​ 4. Stockholders’ Equity Authorized capital stock The Company’s authorized capital stock consists of an unlimited number of common shares, no par value per share. 14 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ Warrants to Purchase Common Stock During the three and nine months ended September 30, 2023 and 2022, there were no warrants issued or exercised . The company has 150 outstanding warrants have a weighted average life of 4.30 years, and a weighted average strike price of $ 7.79 , on September 30, 2023. ​ Equity Incentive Plan The Compensation Committee of the Board of Directors administers the Company’s equity incentive plan (the “Plan”). The Compensation Committee designates eligible participants to be included under the Plan and approves the number of equity instruments to be granted from time to time under the Plan. Currently, the maximum number of equity instruments issuable under the Plan, together with the Company’s prior stock option plan, is twenty-five percent ( 25 %) of the total number of issued and outstanding common shares. Based upon the current shares outstanding, a maximum of 6,658 shares of common stock are authorized for issuance pursuant to stock options or other equity awards granted under the Plan. For all options issued under the Plan, the exercise price is the fair value of the underlying shares on the date of grant. All options vest within three years or less and are exercisable for a period of ten years from the date of grant. The Plan allows the issuance of Canadian and U.S. dollar grants. The table below outlines recognized contractor and employee expense from equity awards for the three and nine month periods ended September 30, 2023 and 2022. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ September 30, ​ September 30, ​ September 30, ​ September 30, ​ 2023 ​ 2022 2023 ​ 2022 Contractor options expense recognized ​ $ — ​ $ 34 ​ $ — ​ $ 103 Employee options expense recognized ​ 865 ​ 1,853 ​ ​ 4,497 ​ ​ 3,260 Total option expense recognized ​ $ 865 ​ $ 1,887 ​ $ 4,497 ​ $ 3,363 ​ ​ Stock Option Activity The following is a summary of option activity for the three and nine months ended September 30, 2023 for stock options denominated in U.S. dollars. ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted-Average Options ​ Options (thousands) Exercise Price $USD Outstanding at December 31, 2022 ​ 4,539 ​ $ 5.13 Granted ​ 580 ​ 8.12 Exercised ​ ( 49 ) ​ 4.36 Forfeited ​ ( 38 ) ​ ​ 6.98 Outstanding at March 31, 2023 ​ 5,032 ​ ​ 5.43 Granted ​ 125 ​ ​ 8.80 Exercised ​ ( 95 ) ​ ​ 5.60 Forfeited ​ ( 175 ) ​ ​ 7.51 Outstanding at June 30, 2023 ​ 4,887 ​ $ 5.77 Granted ​ 370 ​ ​ 7.88 Exercised ​ ( 92 ) ​ ​ 2.34 Forfeited ​ ( 160 ) ​ ​ 7.35 Outstanding at September 30, 2023 ​ 5,005 ​ $ 5.94 ​ 15 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ Of the 5,005 U.S. denominated options granted and outstanding at September 30, 2023, 3,932 are fully vested and exercisable. The value of options issued was estimated using the Black-Scholes option pricing model using the assumptions in the table below. The expected volatility was determined using historical volatility of our common shares based on the expected term of the award. ​ ​ ​ ​ ​ ​ Valuation ​ ​ Assumptions Black-Scholes Model Assumptions ​ September 30, 2023 Expected dividend 0.00 % Risk free rate 3.56 - 5.12 % Expected volatility ​ 49 - 77 % Expected life ​ 1.5 - 6.0 years ​ 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 three and nine months ended September 30, 2023. During the three and nine months ended September 30, 2023, there were 32 and 36 RSU’s released from restriction, respectively. During the three and nine months ended September 30, 2023, there were 84 and 101 RSUs forfeited by departing employees. RSUs vesting vary from one to three years . ​ ​ ​ ​ ​ ​ Number of ​ ​ Restricted Share RSUs Current Year ​ Units (thousands) Outstanding at December 31, 2022 35 Awarded 264 Released ​ ( 1 ) Outstanding at March 31, 2023 ​ 298 Awarded ​ 98 Released ​ ( 3 ) Forfeited ​ ( 17 ) Outstanding at June 30, 2023 ​ 376 Awarded ​ — Released ​ ( 32 ) Forfeited ​ ( 84 ) Outstanding at September 30, 2023 ​ 260 ​ The value of RSUs issued was estimated using the share price on the date of the award multiplied by the number of common shares granted. ​ ​ ​ 5. Fair Value Measurements The Company has adopted ASC 820, the 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 16 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share 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. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurement at September 30, 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 ​ $ 2,007 (1) $ 307 (1) $ 10,392 $ 23,467 $ — $ — $ 12,399 $ 23,774 Processa common shares ​ $ 13 (2) $ 56 (2) $ — $ — $ — $ — $ 13 $ 56 ​ (1) The Company held approximately $ 2,007 in cash as of September 30, 2023, of which approximately $ 488 was in Canadian funds (translated into U.S. dollars). As of December 31, 2022, the Company held approximately $ 307 in cash of which approximately $ 33 was in Canadian funds (translated into U.S. dollars). (2) The Company holds 51 unrestricted common shares of Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), which it received as part of a royalty arrangement in 2020. ​ 6. Commitments and Contingencies Oregon Health & Science University Agreement On February 20, 2013, we entered into an exclusive license agreement with Oregon Health & Science University (“OHSU”) for exclusive worldwide license rights to intellectual property directed to thiol-based compounds, including PEDMARK ® , and their use in oncology (the “OHSU Agreement”). OHSU will receive certain milestone payments, royalty on net sales for licensed products and a royalty on any consideration received from sublicensing of the licensed technology. On May 18, 2015, we 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 sodium thiosulfate for the prevention of ototoxicity induced by chemotherapeutic agents to treat cancers. Further, Amendment 1 adjusts select milestone payments in the OHSU Agreement including but not limited to the royalty rate on net sales for licensed products, royalty rate from sublicensing of the licensed technology and the fee payable upon the regulatory approval of a licensed product. 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. In the event a licensed product obtains regulatory approval and is covered by the Orphan Drug Designation, the parties will in good faith amend the term of the agreement. PEDMARK ® is currently protected by methods of use patent that the Company exclusively licensed from OHSU 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. Securities Class Action Suit Chapman v. Fennec Pharmaceuticals Inc., et al. On September 3, 2020, plaintiff Jim Chapman filed a putative federal securities class action lawsuit against the Company, our Chief Executive Officer, Rostislav Raykov, and Chief Financial Officer, Robert Andrade, in the United States District 17 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ Court for the Middle District of North Carolina, captioned Chapman v. Fennec Pharmaceuticals Inc., et al ., Case No. 1:20-cv-00812. The complaint alleged that prior to our August 10, 2020 receipt of a CRL from the FDA concerning our NDA for PEDMARK ® , defendants made materially false or misleading statements and failed to disclose material facts about our third-party PEDMARK ® product manufacturing facility and the impact the facility would have on regulatory approval for PEDMARK ® . On December 3, 2020, the court appointed a lead plaintiff to represent the putative class. On February 1, 2021, the lead plaintiff filed an amended complaint. The amended complaint added members of our Board of Directors as defendants, asserted a putative class period from December 20, 2018 through August 10, 2020, made allegations similar to those in the original complaint, claimed that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, and sought an unspecified amount of compensatory damages and attorneys’ fees and costs. On March 3, 2021, defendants filed a motion to dismiss the amended complaint. On April 2, 2021, lead plaintiff filed an opposition to the motion to dismiss. On April 16, 2021, defendants filed a reply in support of the motion to dismiss, and on December 16, 2021, the Magistrate Judge entered an order recommending that defendants’ motion to dismiss be granted in its entirety. On January 24, 2022, lead plaintiff filed objections to the Magistrate Judge’s recommendation, and defendants filed their response on February 3, 2022. On March 2, 2022, the U.S. District Court Judge adopted the Magistrate Judge’s order and recommendation and entered an order and judgment dismissing the amended complaint with prejudice. On March 30, 2022, lead plaintiff filed a motion for post judgment relief, seeking leave to file a second amended complaint. In his proposed second amended complaint, lead plaintiff sought to add allegations stemming from the receipt of a second CRL following our resubmission of our NDA for PEDMARK ® , which we received on November 29, 2021, among other things. Defendants filed an opposition to plaintiff’s motion for post judgment relief on April 20, 2022. On May 4, 2022, lead plaintiff submitted a reply in support of his motion. On September 27, 2022, defendants filed a request for judicial notice regarding the FDA’s press release announcing that it has approved PEDMARK ® . On October 18, 2022, lead plaintiff filed his opposition to request for judicial notice. On October 21, 2022, defendants filed a reply in support of the request for judicial notice. On February 15, 2023, the Magistrate Judge recommended the motion for post judgment relief be denied. Lead plaintiff filed no timely objection to the recommendation, and on March 2, 2023, the U.S. District Court Judge issued an order adopting the Magistrate Judge’s recommendation, denying the motion for post judgment relief, and entering judgment for defendants. Lead plaintiff had until April 3, 2023 to file a notice of appeal and did not file a notice of appeal. The case is now closed. Fisher v. Fennec Pharmaceuticals Inc. et al. On February 9, 2022, plaintiff Jeffrey D. Fisher filed a putative federal securities class action lawsuit against the Company and our CEO and CFO in the United States District Court for the Middle District of North Carolina, captioned Fisher v. Fennec Pharmaceuticals Inc., et al. , Case No. 1:22-cv-00115. The complaint asserted a putative class period from May 28, 2021 through November 28, 2021, and alleged that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 by making materially false and misleading statements or omissions regarding the status of our third-party PEDMARK ® product manufacturing facility, the facility’s compliance with cGMP, and the impact its status and compliance would have on regulatory approval for PEDMARK ® in the period leading up to the Company’s November 29, 2021 receipt of a CRL for a subsequent NDA for PEDMARK ® . The complaint sought an unspecified amount of damages and attorneys’ fees and costs. On April 11, 2022, plaintiff Jeffrey D. Fisher filed a motion to be appointed lead plaintiff and represent the putative class and on May 9, 2022, the court appointed him as lead plaintiff. On June 23, 2022, lead plaintiff filed an amended complaint. The amended complaint asserted the same putative class period from May 28, 2021 through November 28, 2021, was brought against the same defendants and made allegations similar to those in the original complaint. On August 5, 2022, defendants filed a motion to dismiss the amended complaint. On August 26, 2022, lead plaintiff filed an opposition to the motion to dismiss. On September 9, 2022, defendants filed a reply in support of the motion to dismiss. 18 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ On September 27, 2022, defendants filed a request for judicial notice regarding the FDA’s press release announcing that it approved PEDMARK ® . On September 30, 2022, lead plaintiff filed an opposition to the request for judicial notice. On October 6, 2022, defendants filed a reply in support of the request for judicial notice. On October 12, 2022, the U.S. District Court Judge issued a memorandum opinion and order dismissing the amended complaint in its entirety and with prejudice, and on October 14, 2022, entered judgment. Lead plaintiff had until November 14, 2022 to file a notice of appeal and did not file a notice of appeal. The case is now closed. Hope Medical Enterprises, Inc. Inter Partes Review 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 ® . The ‘190 Patent was issued on March 24, 2020. On December 5, 2022, a Fennec filed a Motion to Amend the single claim of the ‘190 Patent focing on the treatment of medulloblastoma. On April 18, 2023, the PTAB invalidated the only claim of the‘190 Patent. The final written decision became effective June 20, 2023. The ‘190 Patent was previously listed in the United States Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the “Orange Book”). In light of PTAB’s final written decision on the invalidity of the ‘190 Patent, we requested that the FDA remove the ’190 Patent from the Orange Book. Two United States patent applications claiming priority through the ‘190 Patent remain pending at the United States Patent and Trademark Office (“USPTO”). ​ 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 ® product. The ‘363 Patent was issued October 6, 2020. In May 2022, the PTAB granted Hope’s Petition to Institute the IPR against the ‘363 patent. During the ‘363 IPR, we disclaimed the patent claims directed to the anhydrous morphic form of STS and continued with claims directed to its method of manufacture. Because the remaining claims in the ‘363 patent are directed to a method of manufacture, the ‘363 patent is not eligible for listing in the Orange Book. In September 2023, the PTAB issued a Final Written Decision in favor of Fennec and upholding the amended claim. Hope has until November 3, 2023 to request that PTAB reconsider the Final Written Decision, or alternatively, file an appeal of the Final Written Decision with the Court of Appeals for the Federal Circuit. If no further actions are taken, the ‘363 Patent as amended will remain in force. The USPTO has now granted three additional U.S. patents that cover the PEDMARK ® formulation, each of which have been listed in the U.S. FDA’s “Orange Book” (U.S. Patent No. 11,291,728 (issued April 5, 2022), U.S. Patent No. 11,510,984 (issued November 29, 2022), and U.S. Patent No. 11,617,794 (issued April 4, 2023)), and additional United States patent applications from this family remain pending at the USPTO. We plan to vigorously defend our intellectual property rights to PEDMARK ® . An invalidation of our patents covering PEDMARK ® could have a material adverse effect on our ability to protect our rights in PEDMARK ® beyond periods of marketing exclusivity for PEDMARK ® in the United States under Orphan Drug Designation. CIPLA ANDA 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 ® (sodium thiosulfate solution) that contains Paragraph IV Certifications on two of our patents covering PEDMARK ® : the OHSU licensed ‘190 Patent, expiration date January 2038; and our US 11,291,728 Patent (the “’728 Patent”), expiration date July 2039. On January 6, 2023, we received a letter dated January 5, 2023, notifying us that CIPLA submitted to the FDA a Paragraph IV Certification on our newly issued US 11,510,984 Patent (the “’984 Patent”). These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for PEDMARK ® . The certifications allege these patents are invalid or will not be infringed by the manufacture, use, or sale of CIPLA’s sodium thiosulfate solution. 19 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ 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 ® . In addition to the 30 -month stay, because we have received Orphan Drug Exclusivity, the FDA may not approve CIPLA’s ANDA for at least 7 years from PEDMARK ® ’s FDA approval date of September 20, 2022. 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 ® product, which was listed in the Orange Book on or around April 17, 2023, and has an expiration date of July 2039. On May 11, 2023, we received written notice of CIPLA’s Paragraph IV Certification as to the ’793 Patent, which was dated May 10, 2023, along with an enclosed statement of alleged factual and legal bases for stating that the ’793 Patent is invalid, unenforceable, and/or will not be infringed by CIPLA’s ANDA Product. On July 27, 2023, we filed a Second Amended Complaint to assert the ‘793 Patent. The suit is ongoing. PEDMARQSI TM (EU Brand name for PEDMARK ® ) received European Commission approval in June 2023 and was granted 10 years of market exclusivity in Europe under Pediatric Use (“PUMA”). 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 ). 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 at 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 months’ 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 basis points for operating leases that 20 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ commenced after August 2023. The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term. ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2023 ​ ​ ​ ​ ​ ​ Remaining lease terms (in months) ​ 16 ​ Discount rate ​ 10 % ​ ​ ​ ​ Maturities of lease liabilities as of September 30, 2023 were as follows (in thousands): ​ ​ ​ Year Ending December 31, ​ ​ ​ 2023 (remaining three months) ​ $ 6 ​ 2024 ​ ​ 23 ​ 2025 ​ ​ 2 ​ ​ ​ ​ 31 ​ Less imputed interest ​ ​ 2 ​ Total lease liabilities ​ $ 29 ​ ​ ​ ​ ​ ​ Current operating lease liabilities ​ $ 21 ​ Non-current operating lease liabilities ​ ​ 8 ​ Total lease liabilities ​ $ 29 ​ ​ ​ ​ 7. 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 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 the second tranche of the Note Financing in the amount of $ 20,000 , 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 the Second Closing Trigger. Subsequent to the funding of the Second Closing Note, and before December 31, 2023, the Company may draw up to $ 20,000 of additional financing under the SPA, in one or more tranches of $ 10,000 upon mutual agreement of the Company and the Investor. The Subsequent Closing Notes will be convertible at a price per share equal to $ 7.89 per share, which price is calculated on the same basis as for the Second Closing Note. A commitment fee of 2.0 % of the Notes was payable under the SPA. Half of such fee was paid by the issuance on the first closing of warrants to purchase approximately 0.05 Fennec common shares and half was payable in cash or warrants of approximately 0.05 Fennec common shares, at our election, on the second closing. The Company chose to issue warrants to satisfy the payable on both the first and second closing. The warrants are exercisable at a price per share of $ 8.11 and both have a maturity date of August 19, 2027. Cash interest on outstanding principal shall accrue at a rate of prime, plus 4.5 % per annum, from the date of funding ( 12.75 % at September 30, 2023 and 12 % as of December 31, 2022). Cash interest is due on the first business day of each calendar quarter (“Interest Date”). In addition to cash interest, 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 21 Table of Contents Fennec Pharmaceuticals Inc. Notes to the Unaudited Interim Condensed Consolidated Financial Statements (U.S. dollars and shares in thousands, except per share information) ​ shall remain outstanding and be payable on each Interest Date and be added to the outstanding principal amount. The Company has accrued $ 0.71 in PIK interest and has classified the PIK interest in long-term liabilities. The Notes are convertible into fully paid, non-assessable shares of the Company’s common shares at any point after their issuance dates and before the maturity date. Any amount of the Notes may be converted into the Company’s 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 SPA 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 September 30, 2023 are as follows (in thousands): ​ ​ ​ ​ ​ Years Ending December 31, ​ Amount 2023 $ — 2024 ​ — 2025 ​ ​ — 2026 ​ ​ — 2027 ​ ​ 25,000 Payment in kind interest ​ ​ 937 Total future payments ​ ​ 25,937 Less: unamortized debt discount ​ ​ ( 298 ) Total term loan, net of debt discount ​ $ 25,639 ​ 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 to the Investor to secure access to the SPA. These amounts were capitalized and are being amortized over the access period of the SPA. Upon closing on the First Closing Note and the Second Closing Note, 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. ​ 8. Subsequent Events Management has evaluated subsequent events through the date of this filing and concluded there are no events of significance which require disclosure . ​ ​ ​ 22 Table of Contents