Allarity Therapeutics, Inc. 10-K

ITEM 5 - MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market for Common Stock Our common stock is traded on Nasdaq under the symbol “ALLR”. Prior to the consummation of the Recapitalization Share Exchange, Allarity Therapeutics A/S ordinary shares were listed on the Nasdaq First North Growth Market: Stockholm under the symbol “ALLR:ST.” Holders of Record of Common Stock As of May 1, 2022, we had approximately 2 stockholders of record for our common stock. The foregoing number of stockholders of record does not include an unknown number of stockholders who hold their stock in “street name.” Dividend Policy We do not anticipate declaring or paying, in the foreseeable future, any cash dividends on our common stock. We intend to retain all available funds and future earnings, if any, to fund the development and expansion of our business. Any future determination regarding the declaration and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. Recent Sales of Unregistered Securities Pursuant to the Purchase Agreement with the Investor, we issued 20,000 shares of our Series A Preferred Stock and a warrant to purchase 2,018,958 shares of common stock at an initial exercise price of $9.9061 to the Investor along with a PIPE Warrant, for an aggregate purchase price of $20 million. Simultaneously with the execution of the SPA, we also entered into a Registration Rights Agreement with the Investor wherein we agreed to register a number of shares of our common stock equal to the maximum number of shares of our common stock that could be issued upon conversion of the Series A Preferred Stock using a conversion price equal to 20% of $80,000,000 divided by the number of shares of common stock then outstanding plus 125% of the shares of common stock issuable upon exercise of the PIPE Warrant, or a maximum of 12,618,590 shares of our common stock. Pursuant the to the Registration Rights Agreement, on September 13, 2021, we filed a registration statement with the SEC registering 12,618,590 shares of common stock which such registration statement was declared effective on December 20, 2021. From December 23, 2021, to May 1, 2022, pursuant to a series of exercise of conversion by the Investor, we issued 766,466 shares of Common Stock to the Investor upon the conversion of 2,173 shares of Series A Preferred Stock. As of May 1, 2022, we had 17,827 shares of Series A Preferred Stock issued and outstanding. The offers, sales, and issuances of the Series A Preferred Stock and PIPE Warrant to the Investor described above were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D promulgated thereunder as transactions by an issuer not involving a public offering. Each of the recipients of securities in these transactions was an accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act. 170 Purchases of Equity Securities None. Equity Compensation Plan Information The following table provides certain information with respect to our equity compensation plans in effect as of December 31, 2021, on a post-Recapitalization Shares Exchange basis: Number of securities to be issued upon exercise of outstanding options, and settlement of RSUs (a) Weighted- average exercise price of outstanding options, and issuance price of RSUs (b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column a) (c) Equity compensation plans approved by security holders (1) 1,174,992 $ 6.80 - Equity compensation plans approved by security holders (2) — — 1,211,374 (2) Total 1,174,992 $ 6.80 1,211,374 (2) (1) Upon the closing of the Recapitalization Share Exchange and as of December 31, 2021, we had converted compensatory options to purchase ordinary shares of Allarity Therapeutics A/S to options to purchase 1,174,992 shares of our common stock. (2) Consists of 1,211,374 shares of our common stock initially reserved under the 2021 Equity Incentive Plan (“2021 Plan”). The number of shares reserved for issuance under our 2021 Plan increases automatically on January 1 of each of 2022 through 2031 by the number of shares equal to the lesser of 5% of the aggregate number of outstanding shares of our common stock as of the immediately preceding December 31, or a number as may be determined by our board of directors. 171 ITEM 6 – [RESERVED] ITEM 7. - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis provide information which Allarity Therapeutics’ management believes is relevant to an assessment and understanding of Allarity Therapeutics Inc’s consolidated results of operations and financial condition. You should read the following discussion and analysis of Allarity Therapeutics’ financial condition and results of operations together with Allarity Therapeutic Inc.’s audited consolidated financial statements and notes thereto included elsewhere in this Annual Report. In addition to historical financial information, this discussion contains forward-looking statements based upon Allarity Therapeutics’ current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report. Unless otherwise indicated or the context otherwise requires, references in this Management’s Discussion and Analysis of Financial Condition and Results of Operations section to “Allarity Therapeutics,” “we,” “us,” “our,” and other similar terms refer to Allarity Therapeutics Inc. and its consolidated subsidiaries. We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Overview We are a biopharmaceutical company focused on discovering and developing highly targeted anti-cancer drug candidates. Using its Drug Response Predictor (DRP ® ) platform, the Company identifies the value in drug assets that have otherwise been discontinued by identifying patient populations where these drugs are active. The Company’s three lead drug candidates are: the tyrosine kinase inhibitor (TKI) dovitinib, the poly-ADP-ribose polymerase (PARP) inhibitor stenoparib, and the microtubule inhibitor agent IXEMPRA. Risks and Uncertainties The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s research and development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Impacts of COVID-19 on our Business — Update In March 2020, the World Health Organization declared COVID-19 a global pandemic. COVID-19 has had an impact on our operations as it caused some unexpected delays in our clinical program activities as clinical trials were delayed. Management is unable to estimate the future financial effects, if any, to our business because of COVID-19 because of the high level of uncertainties and unpredictable outcomes of this disease. 172 We are continuing to evaluate the impact of COVID-19 pandemic on our business and are taking proactive measures to protect the health and safety of our employees, as well as to maintain business continuity. Based on guidance issued by federal, state, and local authorities, we transitioned to a remote work model for our employees, effective March 16, 2020. During the last two quarters of the year ended December 31, 2021 and the first quarter of 2022, restrictions due to COVID-19 have lifted significantly and as a result, our Danish employees have returned to work. Our North American employees are continuing to work remotely. We will continue to closely monitor and seek to comply with guidance from governmental authorities and adjust our activities as appropriate. The ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trial, healthcare systems or the global economy. However, these effects could harm our operations, and we will continue to monitor the COVID-19 situation closely. Impact of the Russia-Ukraine War There have been immense flows of refugees to Europe and Denmark is ready to facilitate and to accept refugees from the Ukraine. It is far too early to estimate how many migrants Denmark will facilitate, but immigration officials have begun preparing to accept Ukrainian refugees. Being a North Atlantic Treaty Organization (NATO) member, Denmark will strengthen its own national preparedness as well as that of the NATO defense alliance. We expect the Ukraine crisis will have an impact on the Danish and worldwide economy and energy supply, potentially increasing the Company’s costs. Financial Operations Overview Since our inception in September of 2004, we have focused substantially all our resources on conducting research and development activities, including drug discovery and preclinical studies, establishing, and maintaining our intellectual property portfolio, the manufacturing of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. In recent years, we have recorded very limited revenue from collaboration activities, or any other sources. We have funded our operations to date primarily from convertible notes and the issuance and sale of our ordinary shares. We have incurred net losses in each year since inception. Our net losses were $26.6 million and $6.6 million for 2021 and 2020, respectively. As of December 31, 2021, we had an accumulated deficit of $66.5 million. Substantially all our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we: ● advance drug candidates through clinical trials; ● pursue regulatory approval of drug candidates; ● operate as a public company; ● continue our preclinical programs and clinical development efforts; ● continue research activities for the discovery of new drug candidates; and ● manufacture supplies for our preclinical studies and clinical trials. 173 Components of Operating Expenses Research and Development Expenses Research and development expenses include: ● expenses incurred under agreements with third-party contract organizations, and consultants; ● costs related to production of drug substance, including fees paid to contract manufacturers; ● laboratory and vendor expenses related to the execution of preclinical trials; ● employee-related expenses, which include salaries, benefits and stock-based compensation; and ● maintenance and renewal fees for patents. We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our vendors and third-party service providers. Non-refundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and accounted for as prepaid expenses. The prepayments are then expensed as the related goods are delivered and as services are performed. To date, most of these expenses have been incurred to advance our lead drug candidates, dovitinib, stenoparib, and IXEMPRA ® . We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our drug candidates, as our drug candidates advance into later stages of development, and as we continue to conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our drug candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our drug candidates. Results of Operations Comparison of years ended December 31, 2021 and 2020 The following table summarizes our results of operations for the years ended 2021 and 2020: For the years ended December 31, Increase/ 2021 2020 (Decrease) (In thousands) Operating expenses: (Restated) Research and development $ 14,196 $ 4,218 $ 9,978 General and administrative 12,360 4,101 8,259 Total operating costs and expenses 26,556 8,319 18,237 Loss from operations: $ (26,556 ) $ (8,319 ) $ (18,237 ) 174 Research and Development Expenses We currently do not track our research and development costs by product candidate. A breakdown by nature of type of expense for the years ended December 31, 2021, and December 31, 2020, is provided below. For the year ended December 31, Increase/ 2021 2020 (Decrease) (In thousands) (Restated) Research study expenses $ 2,329 $ 2,119 $ 210 Recovery of R&D costs — (22 ) 22 Tax credit (875 ) (908 ) 33 Milestone payments 5,000 — 5,000 Manufacturing & supplies 1,105 332 773 Contractors 2,765 1,106 1,659 Patents 273 198 75 Staffing 3,429 954 2,475 Amortization 103 149 (46 ) Other 67 290 (223 ) $ 14,196 $ 4,218 $ 9,978 For the year ended December 31, 2021, versus December 31, 2020: The increase of $10.0 million in research and development cost was due to an increase of $210 thousand in research study expenses, a decrease of $22 thousand in recovery of R&D costs, a decrease of $33 thousand in tax credits, an increase of $5.0 million in milestone payments, an increase of $773 thousand in manufacturing and supplies, an increase of $1.7 million in contractors costs, an increase in patents expenses of $75 thousand, and an increase in staffing costs of $2.5 million, offset by a reduction in amortization expenses of $46 thousand and reduced other costs of $223 thousand. Overall, the increase was because during the year ended December 31, 2020, our research and development activity was paused or significantly slowed due to Covid-19. Research and development in the last two quarters of the year ended December 31, 2021, increased as activity in the clinical trials coming back to a pre-pandemic level. The milestone payment to Novartis was due to the NDA filing. Manufacturing & supplies and contractor costs have increased significantly in preparation of our NDA filing for Dovitinib. Staffing costs increased primarily because of stock option grants and bonuses. General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and professional services expenses, including legal, human resources, audit, and accounting services. Personnel-related costs consist of salaries, benefits, and stock-based compensation. Facilities costs consist of rent and maintenance of facilities. Legal costs incurred in connection with patents are accounted for as general and administrative expense. We expect our general and administrative expenses to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates and because of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, Nasdaq, additional insurance expenses, investor relations activities and other administrative and professional services. General and administrative expenses increased by $8.3 million for the year ended December 31, 2021, compared to 2020. The increase was primarily due to an increase in professional fees of $3.3 million, staffing expenses of $4 million, listings expenses of $547 thousand, premises expenses of $8 thousand, insurance of $60 thousand, and $243 thousand in other administrative costs. Professional fees, listing costs and other administrative expenses all increased as the Company prepared its prospectus to file with the SEC and list on Nasdaq in the U.S. Staffing costs increased primarily because of stock option grants and bonuses. 175 Other Income (Expenses), Net (2020 restated – see Financial Statement Note 3) Other income (expense) of $41 thousand recognized in the year ended December 31, 2021, consisted primarily of a $2.1 million fair value adjustment to warrants and derivative liabilities, and $1.0 million in other income received in connection with our sale of intangible IP assets to Lantern Pharma, offset by ($1.3) million in finance expenses, ($499) thousand in interest expenses, ($495) thousand in loss on our equity investment in Lantern Pharma, Inc., a ($474) thousand change in fair value of convertible debt, a ($141) thousand loss on extinguishment of convertible debt, and net foreign exchange losses of ($95) thousand. Other income (expense) of $1.9 million recognized in the year ended December 31, 2020, consisted primarily of a $2.1 million fair value adjustment to derivative liabilities, a gain of $708 thousand on our investment in Lantern Pharma, and a net foreign exchange gain of $62 thousand, offset by a ($573) thousand change in fair value of convertible debt, ($108) thousand loss on extinguishment of convertible debt, and ($320) thousand in interest expenses. Changes in fair value of our derivative liabilities and convertible debt are measured using level 3 inputs as described in our consolidated financial statements. Income taxes (2020 restated – see Financial Statement Note 3) During the years ended December 31, 2021, and December 31, 2020, we recognized ($133) and ($198) thousand in income tax expense respectively. 176 Liquidity, Capital Resources and Plan of Operations Since our inception through December 31, 2021, our operations have been financed primarily by the sale of preferred stock, convertible promissory notes and the sale and issuance of our ordinary shares. As of December 31, 2021, we had $19.6 million in cash, and an accumulated deficit of $66.5 million. In the year ended December 31, 2021, we received $20 million in gross proceeds from the issuance of Series A preferred stock, $14.9 million in gross proceeds from the issuance of shares, and $1.1 million in proceeds from convertible debt. We also received and repaid a bridge loan of $2.9 million, and we received $1 million in proceeds from the sale of IP. In the year ended December 31, 2020, we received $3.0 million in net proceeds from the sale and issuance of convertible notes. We also received $3.7 million in proceeds from share issuance. Our primary use of cash is to fund operating expenses, which consist of research and development as well as regulatory expenses related to our lead drug candidate, dovitinib, and clinical programs for stenoparib and IXEMPRA ® , and to a lesser extent, general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. As of December 31, 2021, the Company’s cash deposits of $19.6 million were determined to be insufficient to fund its current operating plan and planned capital expenditures for at least the next 12 months. We estimate that as of the date of this filing, our cash reserves are sufficient for approximately 6 months. These conditions give rise to a substantial doubt over the Company’s ability to continue as a going concern. Management’s plans to mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity, debt financing, collaboration partnerships, or other sources. There are no assurances, however, that the Company will be successful in raising additional working capital, or if it is able to raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital or enter other such arrangements when needed would have a negative impact on its business, results of operations and financial condition and its ability to develop its product candidates. We expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our drug candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing, or aggregate amount of costs for our development, potential commercialization, and internal research and development programs. However, to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our drug candidates, as well as to build the sales, marketing, and distribution infrastructure that we believe will be necessary to commercialize our drug candidates, if approved, we may require substantial additional funding in the future. 177 Cash Flows The following table summarizes our cash flows for the years indicated: (In thousands) Year Ended December 31, 2021 Year Ended December 31, 2020 (Restated – Financial Statements Note 3) Net Cash used in operating activities $ (15,050 ) $ (7,251 ) Net Cash provided by (used) in investing activities 1,000 (3 ) Net Cash provided by financing activities 33,819 6,033 Net increase (decrease) in cash $ 19,769 $ (1,221 ) Operating Activities During the year ended December 31, 2021, cash used in operating activities of $15.0 million was attributable to a net loss of $26.6 million, and $6.0 million in net non-cash charges. This was offset by a $5.6 million change in net operating assets and liabilities. The non-cash charges consisted of stock-based compensation of $6.4 million, deferred tax expense of $20 thousand, non-cash interest of $238 thousand, loss on investment of $495 thousand, non-cash finance costs of $1.3 million, an increase in fair value adjustment of convertible debt of $474 thousand, loss on extinguishment of convertible debt of $141 thousand, depreciation and amortization of $106 thousand, and gain on foreign currency of $74 thousand, offset by a $2.1 million fair value adjustment to derivative liabilities and $1.0 million gain from the sale of IP. The change in operating assets and liabilities of $5.6 million was primarily due to a $7.2 million increase in accrued liabilities, a decrease in prepaid expenses of $130 thousand, and a decrease in income taxes receivable of $8 thousand, offset by a $1.3 million decrease in accounts payable, a $330 increase in other current assets, and a decrease in operating lease liability of $124 thousand. During the year ended December 31, 2020, cash used in operating activities of $7.3 million was attributable to a net loss of $6.6 million, and $1.1 million in net other non-cash charges. This was offset by a $445 thousand change in net operating assets and liabilities. The non-cash charges consisted of a $2.1 million increase in fair value adjustment of the derivative liability, a $708 gain on investment, a $68 thousand gain on foreign currency, deferred income tax expense of $165 thousand, an increase of $573 thousand in fair value adjustment of convertible debt, $616 thousand in expense related to stock-based compensation, $280 thousand in non-cash interest, $108 thousand in loss on extinguishment of convertible debt, $46 thousand in depreciation and amortization, and $40 thousand in non-cash lease expense. The $445 thousand change in operating assets and liabilities was primarily due to a $605 thousand decrease in accounts receivable and other current assets and a $97 thousand decrease in prepaid expenses, offset by an increase in tax credit receivable of $104 thousand, decrease in accounts payable of $62 thousand, decrease in accrued liabilities of $36 thousand, and a decrease in operating lease liability of $88 thousand. Investing Activities During the year ended December 31, 2021, the Company received $1.0 million in proceeds from the sale of IP. During the year ended December 31, 2020, cash used by investing activities of $3 thousand was used to purchase equipment. 178 Financing Activities During the year ended December 31, 2021, cash provided by financing activities of $33.8 million was related to proceeds of $20 million from the sale of Series A preferred stock, $14.9 million from common stock issuance, and convertible loan proceeds of $1.1 million, offset by $1.6 million in Series A preferred stock issuance costs, $484 thousand in share issuance costs, and $84 thousand repayment of our line of credit. We also received and repaid $2.9 million in loan funding during the year ended December 31, 2021. In 2020, cash provided by financing activities of $6.0 million was related to net proceeds of $3.7 million from the issuance of common shares, $3.0 million from convertible debt, and $84 thousand from line of credit, partially offset by repayment of a loan of $533 thousand and share issuance costs of $223 thousand. Contractual Obligations and Commitments The following table summarizes our commitments and contractual obligations as of December 31, 2021: Payments Due By Period Total Less than 1 Year 1 – 3 Years 3 – 5 Years More than 5 Years (In thousands) Operating lease obligations $ 114 $ 105 $ 9 $ — $ — We enter into agreements in the normal course of business with vendors for preclinical studies, clinical trials and other service providers for operating purposes. We have not included these payments in the table of contractual obligations above since these contracts are generally cancellable at any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations under these agreements are not material. Operating Capital and Capital Expenditure Requirements We believe that the net proceeds from the PIPE Investment, together with our existing cash and cash equivalents as of the date of this Annual Report, and our anticipated expenditures and commitments for calendar year 2022, will enable us to fund our operating expenses and capital expenditure requirements for 6 months from the date of this Annual Report. Our estimate as to how long we expect the net proceeds from the PIPE Investment, together with our existing cash and cash equivalents, to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Critical Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of financial condition and results of operations is based upon our audited condensed consolidated financial statements for the years ended December 31, 2021, and December 31, 2020, which have been prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting years. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the fair value of the Series A preferred shares, warrants, convertible debt and the accrual for research and development expenses, fair values of acquired intangible assets and impairment review of those assets, share based compensation expense, and income tax uncertainties and valuation allowances. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed considering reasonable changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known and if material, their effects are disclosed in the notes to the consolidated financial statements. Actual results could differ from those estimates or assumptions. 179 While our significant accounting policies are described in the notes to our consolidated financial statements for the years ended December 31, 2021, and December 31, 2020, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting years. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the fair value of the Series A preferred shares, warrants, convertible debt, and the accrual for research and development expenses, fair values of acquired intangible assets and impairment review of those assets, share based compensation expense, and income tax uncertainties and valuation allowances. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed considering reasonable changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known and if material, their effects are disclosed in the notes to the consolidated financial statements. Actual results could differ from those estimates or assumptions. Acquired In-Process Research and Development (IPR&D) Acquired IPR&D represents the fair value assigned to research and development assets that the Company acquires and have not been completed at the acquisition date. The fair value of IPR&D acquired in a business combination is recorded on the consolidated balance sheets at the acquisition-date fair value and is determined by estimating the costs to develop the technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the projected net cash flows to present value. IPR&D is not amortized, but rather is reviewed for impairment on an annual basis or more frequently if indicators of impairment are present, until the project is completed, abandoned, or transferred to a third-party. The projected discounted cash flow models used to estimate the fair value of partnered assets and cost approach model used to estimate proprietary assets as part of the Company’s IPR&D reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset, including the following: ● Estimates of obsolescence of development expenditure; ● Probability of successfully completing clinical trials and obtaining regulatory approval; ● Estimates of future cash flows from potential milestone payments and royalties related to out-licensed product sales; and ● A discount rate reflecting the Company’s weighted average cost of capital and specific risk inherent in the underlying assets. Once brought into use, intangible assets are amortized over their estimated useful economic lives, which for acquired IPR&D assets is over the remaining life of the relevant patents. Research contract costs and accruals The Company has entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. 180 Convertible note: The Company accounts for certain convertible notes issued during the years ended December 31, 2021, and December 31, 2020, under the fair value option (“FVO”) election of ASC 825, Financial Instruments (“ASC-825”) as discussed below. The convertible notes accounted for under FVO wherein the financial instrument is initially measured at its issue-date estimated fair value and then subsequently re-measured at estimated fair value on a recurring basis at each reporting period date. The estimated fair value adjustments are based upon a discounted cash flow valuation technique using a weighted cost of capital of 15% and are recognized as other income (expense) in the accompanying consolidated statement of operations and the portion of the fair value adjustment attributed to a change in the instrument-specific credit risk is recognized as a component of other comprehensive income (“OCI”). Convertible debt instruments: The Company follows ASC 480-10, Distinguishing Liabilities from Equity in its evaluation of the accounting for a hybrid instrument. A financial instrument that embodies an unconditional obligation, or a financial instrument other than an outstanding share that embodies a conditional obligation, that the issuer must or may settle by issuing a variable number of its equity shares shall be classified as a liability (or an asset in some circumstances) if, at inception, the monetary value of the obligation is based solely or predominantly on any one of the following: (a) a fixed monetary amount known at inception; (b) variations in something other than the fair value of the issuer’s equity shares; or (c) variations inversely related to changes in the fair value of the issuer’s equity shares. Hybrid instruments meeting these criteria are not further evaluated for any embedded derivatives and are carried as a liability at fair value at each balance sheet date with remeasurements reported in change on fair value expense in the accompanying Statements of Operations. If it is determined that an instrument is not within the scope of ASC 480-10, further evaluation of all identified features is performed pursuant to ASC 815 in order to determine if any bifurcation from the host instrument is required. Warrants When the Company issues warrants, it evaluates the proper balance sheet classification of the warrant to determine whether the warrant should be classified as equity or as a derivative liability on the consolidated balance sheets. In accordance with ASC 815-40, Derivatives and Hedging-Contracts in the Entity’s Own Equity (ASC 815-40), the Company classifies a warrant as equity so long as it is “indexed to the Company’s equity” and several specific conditions for equity classification are met. A warrant is not considered indexed to the Company’s equity, in general, when it contains certain types of exercise contingencies or adjustments to exercise price. If a warrant is not indexed to the Company’s equity or it has net cash settlement that results in the warrants to be accounted for under ASC 480, Distinguishing Liabilities from Equity, or ASC 815-40, it is classified as a derivative liability which is carried on the consolidated balance sheet at fair value with any changes in its fair value recognized immediately in the statement of operations. Warrants are fair valued using either the Black-Scholes option pricing model or Monte Carlo simulations. Both the Black-Scholes option pricing model and Monte Carlo simulations require the use of highly subjective and complex assumptions, including the option’s expected term and the price volatility of the underlying stock, to determine the fair value of the award. As of December 31, 2021, the Company had warrants that were classified as equity and warrants that were classified as liabilities. Derivative Financial Instruments The Company does not use derivative instruments to hedge exposures to interest rate, market, or foreign currency risks. The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the Consolidated Statements of Operations and Comprehensive Loss each reporting period. Bifurcated embedded derivatives are classified as “Derivative liabilities” in the Consolidated Balance Sheets. 181 Share-based compensation The Company accounts for share-based compensation in accordance with ASC 718, Compensation — Stock Compensation (“ASC 718”). ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period in the Company’s consolidated statements of operations and comprehensive loss. The Company records the expense for option awards using either a graded or straight-line vesting method. The Company accounts for forfeitures as they occur. For share-based awards granted to employees, directors and non-employee consultants, the measurement date is the date of grant. The compensation expense is then recognized over the requisite service period, which is the vesting period of the respective award. The Company reviews stock award modifications when there is an exchange of original award for a new award. The Company calculates for the incremental fair value based on the difference between the fair value of the modified award and the fair value of the original award immediately before it was modified. The Company immediately recognizes the incremental value as compensation cost for vested awards and recognizes, on a prospective basis over the remaining requisite service period, the sum of the incremental compensation cost and any remaining unrecognized compensation cost for the original award on the modification date. The fair value of stock options (“options”) on the grant date is estimated using the Black-Scholes option-pricing model using the single-option approach. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, including the option’s expected term and the price volatility of the underlying stock, to determine the fair value of the award. The Company applies the Black-Scholes model as it believes it is the most appropriate fair value method for all equity awards. Contingencies Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. At each reporting date, the Company evaluates whether a potential loss amount or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines that address accounting for contingencies. The Company expenses costs as incurred in relation to such legal proceedings as general and administrative expense within the consolidated statements of operations and comprehensive loss. Interest Rate Risk We had cash of $19.6 million as of December 31, 2021, consisting of cash. We had no cash equivalents at December 31, 2021. To date, fluctuations in interest income have not been significant. We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure. We have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our consolidated financial statements. Recently Issued Accounting Pronouncements See the sections titled “ Recently Adopted Accounting Pronouncements ” in Note 2(dd) and in “ Recently issued accounting pronouncements not yet adopted ” in Note 2(ee) to the Company’s consolidated financial statements for the years ended December 31, 2021, and December 31, 2020, respectively, appearing elsewhere herein. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item. 182 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The financial statements required by this item begin on page F-1 with the index to financial statements followed by the financial statements. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.