RASNA THERAPEUTICS INC. – 10-K/A OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial statements and the related notes and other information that are included elsewhere in this Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under the cautionary note regarding "Forward-Looking Statements" contained elsewhere in this Form 10-K. Additionally, you should read the "Risk Factors" section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Our audited financial statements are presented in
We assume no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.
Unless expressly stated or the context otherwise requires, the terms “Rasna”, “the “Company”, “we”, “us” and “our” refer to
Company Background Overview
To date, we have devoted substantially all of our resources to research and development efforts relating to our therapeutic candidates, including conducting clinical trials and developing manufacturing capabilities, in-licensing related intellectual property, protecting our intellectual property and providing general and administrative support for these operations. Since our inception, we have funded our operations primarily through the issuance of equity securities.
We expect our expenses to increase significantly if and as we:
? continue enrollment in our ongoing clinical trials; ? initiate new clinical trials;
? seek to identify, evaluate, acquire and develop other products, therapeutics
candidates and technologies;
? seek regulatory and marketing approvals in multiple jurisdictions for our
therapeutic candidates that successfully complete clinical studies; ? establish collaborations with third parties for the development and commercialization of our products and therapeutic candidates;
? make milestone payments or other payments under our agreements under which we
have licensed or acquired rights to intellectual property and technology
seek to maintain, protect and develop our intellectual property portfolio;
? seek to attract and retain qualified personnel;
? bear the administrative costs associated with being a public company and
related compliance costs;
? create additional infrastructure to support our operations as
establish a public company and our planned future marketing efforts; and
? experience any delays or encounter issues with any of the above. We expect to continue to incur significant expenses and increasing losses for at least the next several years. Accordingly, we anticipate that we will need to raise additional capital in addition to the net proceeds from this offering in order to obtain regulatory approval for, and the commercialization of our therapeutic candidates. Until such time that we can generate meaningful revenue from product sales, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved therapies or products or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition and results of operations.
We have only one business segment which is a clinical-stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, primarily focusing on the treatment of leukemia.
Summary of Significant Accounting Policies
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in
the United States of America, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. In accordance with US GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are more fully described in Note 2 to our audited consolidated financial statements appearing elsewhere in this Annual Report, we believe the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements. Basis of preparation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America("US GAAP"). Any reference in these notes to applicable guidance is meant to refer to US GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates ("ASU") of the Financial Accounting Standards Board("FASB"). Principles of Consolidation In accordance with ASC 810, Consolidation, the Company consolidates any entity in which it has a controlling financial interest. Further, the Company consolidates any variable interest entity that it is deemed to be the primary beneficiary of, and have the power to direct its significant activities. Upon review of the relationship between Rasna Therapeutics("Rasna UK") and the Company, Management determined that the equity investment in Rasna UKwas not sufficient to fund its operations. Accordingly, the Company is considered to be the primary beneficiary of the assets held within Rasna UK, which primarily consist of cash received from the Company to fund its operations, and has power to direct its significant activities. As a result, the Company consolidates this variable interest entity, which has minimal activity and has been liquidated. The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiary, Rasna Research Inc, and Rasna Research Inc'ssubsidiary, Arna Therapeutics Limited. All significant intercompany accounts and transactions have been eliminated in the preparation of the accompanying consolidated financial statements. 49 Going Concern We are subject to a number of risks similar to those of other pre-commercial stage companies, including its dependence on key individuals, uncertainty of product development and generation of revenues, dependence on outside sources of capital, risks associated with research, development, testing, and obtaining related regulatory approvals of its pipeline products, suppliers and collaborators, successful protection of intellectual property, competition with larger, better-capitalized companies, successful completion of our development programs and, ultimately, the attainment of profitable operations are dependent on future events, including obtaining adequate financing to fulfill its development activities and generating a level of revenues adequate to support the Company's cost structure. We have experienced net losses and significant cash outflows from cash used in operating activities over the past two years, and as of September 30, 2021, had an accumulated deficit of $23,534,479, a net loss for the year ended September 30, 2021of $875,998and net cash used in operating activities of $293,393. These conditions indicate that there is substantial doubt about our ability to continue as a going concern within the next twelve months from the filing date of this annual report on Form 10-K. We expect to continue to incur net losses and have significant cash outflows for at least the next twelve months. We currently have sufficient funds to continue operating until the end of June 2022, but will require significant additional cash resources to launch new development phases of existing products in its pipeline. Additional cash injections are expected from Panetta partners which is expected to enable the Company to continue our operations through at least March 2023, however in the event that we are unable to secure the necessary additional cash resources needed, we may need to slow current development phases or halt new development phases in order to mitigate the effects of the costs of development . The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support our cost structure. Use of Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimates on an ongoing basis, including those related to the fair values of stock based compensation awards, the modification and extinguishment of debt, troubled debt restructuring, derivatives and valuations associated with derivatives, income taxes and contingent liabilities, among others. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable, the results of which form the basis for making judgments about the carrying amounts of assets and liabilities. Actual results could differ from those estimates and such differences could be material to our consolidated financial position and results of operations. 50
Intangible assets are made up of in-process research and development, ("IPR&D") and certain intellectual property ("IP"). The balance of IPR&D represents IPR&D acquired in 2013, which, at the time, was determined to have alternative future uses. IPR&D assets also represent the fair value assigned to acquired technologies in a business combination, which at the time of the business combination have not reached technological feasibility and have no alternative future use. IP assets represent the fair value assigned to technologies, which at the time of acquisition have reached technological feasibility, however, have not yet been put into service. Intangible assets are considered to have an indefinite useful life until the completion or abandonment of the associated research and development projects.
Goodwillrepresents the premium paid over the fair value of the net tangible and intangible assets acquired in business combinations. Goodwillis not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value based test. Goodwillis assessed for impairment on an annual basis or more frequently if events or changes in circumstances indicate that the asset might be impaired. An impairment charge is recognized only when the implied fair value of our reporting unit's goodwill is less than its carrying amount. Management evaluates indefinite life intangible assets for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. The ongoing evaluation for impairment of its indefinite life intangible assets requires significant management estimates and judgment. Management reviews definite life intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Goodwilland intangible assets were fully impaired as of September 30, 2020. Risks and Uncertainties
We intend to operate in an industry that is subject to rapid change. Our operations will be subject to significant risks and uncertainties, including the financial, operational, technological, regulatory and other risks associated with a start-up business, including the potential risk of business failure.
Research and development Expenditure on research and development is charged to the statement of operations in the year in which it is incurred with the exception of expenditures incurred in respect of the development of major new products where the outcome of those projects is assessed as being reasonably certain in regard to viability and technical feasibility. Such expenditure is capitalized and amortized straight line over the estimated period of sale for each product, commencing in the year that sales of the product are first made. To date, we have not capitalized any such expenditures other than certain IPR&D & IP recorded in connection with certain acquisition or equity transactions. Income Taxes
We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which the temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Management considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent earnings experience by jurisdiction, expectations of future taxable income, and the carryforward periods available for tax reporting purposes, as well as other relevant factors. A valuation allowance may be established to reduce deferred tax assets to the amount that management believes is more likely than not to be realized. Due to inherent complexities arising from the nature of the business, future changes in income tax law and variances between actual and anticipated operating results, management makes certain judgments and estimates. Therefore, actual income taxes could materially vary from these estimates. On
December 22, 2017, The Tax Cuts and Jobs Act was signed into law and has resulted in significant change to the U.Scorporate income tax system. These changes include a federal statutory rate reduction from 34% to 21%, a transition tax, which applies to the repatriation of foreign earnings and profits, the elimination or reduction of certain domestic deductions and credits and limitations on the deductibility of interest expense and executive compensation. 51
Changes in tax rates and tax laws are factored into the enactment period.
We recognize in the financial statements the impact of a tax position, if that position is more likely than not to be sustained upon an examination, based on the technical merits of the position. We record a liability for the difference between the benefit recognized and measured and the tax position taken or expected to be taken on our tax return. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. To the extent interest and penalties are not assessed with respect to uncertain tax positions, amounts accrued will be reduced and reflected as a reduction of the overall income tax provision. We have incurred no liability and, therefore, did not need to record interest and penalties during the year ended
September 30, 2021and 2020. Foreign Currency Items included in the financial statements are measured using their functional currency, which is the currency of the primary economic environment in which the company operates. The Company's consolidated financial statements are presented in United StatesDollar ("USD"), which is the company's functional and presentational currency. Net Loss per Share Basic net loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted net loss per share includes potentially dilutive securities such as outstanding options and warrants, using various methods such as the treasury stock or modified treasury stock method in the determination of dilutive shares outstanding during each reporting period. The following table sets forth potential common shares issuable upon the exercise of outstanding options, the exercise of warrants and conversion of loan notes, all of which have been excluded from the computation of diluted weighted average shares outstanding as they would be anti-dilutive, including the impact on dilutive net loss per share of in-the-money warrants: September 30, September 30, 2021 2020 Stock options 3,648,675 3,210,050 Warrants 1,926,501 1,926,501 Convertible Notes 82,487,678 1,562,319 Total shares issuable upon exercise or conversion 88,062,854 6,698,870 Convertible Notes Debt Discount The Company issued certain convertible notes that have certain embedded derivatives and/or required bifurcation. In connection with these features, the Company has recorded a discount to the debt that will be accreted to the face value of the note under the effective interest method over the term of the
Fair value of financial instruments
Fair value is defined under FASB ASC Topic 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for an asset or liability in an orderly transaction between participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. The levels are as follows:
? Level 1 – Quoted prices in active markets for identical assets or liabilities
? Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or corroborated by observable market data for substantially the full term of the assets or liabilities
? Level 3 – Unobservable inputs that rely on little or no market activity and are material to the value of assets or liabilities.
The following is a listing of the Company's liabilities required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of
September 30, 2021: Level 1 Level 2 Level 3 Total Derivative Liability $ - $ - $ 38,018 $ 38,018Equity-Based Payments ASC Topic 718 "Compensation-Stock Compensation" requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. We account for shares of common stock, stock options and warrants issued to employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. We account for stock-based compensation awards issued to non-employees under Financial Accounting Standards Board("FASB") Accounting Standards Codification ("ASC") No. 718-10, Compensation - Stock Compensation - Overall, and uses the Black-Scholes Merton option-pricing model to determine the fair value of such awards. The Company values awards issued to non-employees on the grant date and has elected to estimate forfeitures as they occur and uses the simplified method to estimate the term of such awards. The Company recognizes stock-based compensation expense related to non-employee awards on a straight-line basis over the service period. 53
Recent accounting pronouncements
August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on the issuer's accounting for convertible debt instruments by removing the separation models for (1) convertible debt with a cash conversion feature and (2) convertible instruments with a beneficial conversion feature. As a result, entities will not separately present in equity an embedded conversion feature in such debt and will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. The elimination of these models will reduce reported interest expense and increase reported net income for entities that have issued a convertible instrument that is within the scope of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and treasury stock method will be no longer available. ASU 2020-06 is applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The Company does not intend to early adopt and continues to evaluate the impact of the provisions of ASU 2020-06 on its consolidated financial statements. In December 2019, the FASB issued ASU 2019 -12, Income Taxes - Simplifying the Accounting for Income Taxes ("ASU 2019-12"). Among other items, the amendments in ASU 2019-12 simplify the accounting treatment of tax law changes and year-to-date losses in interim periods. An entity generally recognizes the effects of a change in tax law in the period of enactment; however, there is an exception for tax laws with delayed effective dates. Under current guidance, an entity may not adjust its annual effective tax rate for a tax law change until the period in which the law is effective. This exception was removed under ASU 2019-12, thereby providing that all effects of a tax law change are recognized in the period of enactment, including adjustment of the estimated annual effective tax rate. Regarding year-to-date losses in interim periods, an entity is required to estimate its annual effective tax rate for the full fiscal year at the end of each interim period and use that rate to calculate its income taxes on a year-to-date basis. However, current guidance provides an exception that when a loss in an interim period exceeds the anticipated loss for the year, the income tax benefit is limited to the amount that would be recognized if the year-to-date loss were the anticipated loss for the full year. ASU 2019-12 removes this exception and provides that, in this situation, an entity would compute its income tax benefit at each interim period based on its estimated annual effective tax rate. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, including interim periods within those annual periods. Early adoption is permitted. The Company is currently evaluating the effect that this update will have on its financial statements and related disclosures.
The Company has determined that all other accounting pronouncements recently issued will not have a material impact on its consolidated financial position, results of operations and cash flows, or will not apply to its business.
Results of Operations
The following paragraphs present our results of operations for the periods presented. Comparison of financial results from period to period is not necessarily indicative of future results.
Results of operations for the years ended
There was no revenue for the year ended
Operating Expenses Operating expenses consisting of consultancy fees, legal and professional fees and general and administrative expenses for the year ended
September 30, 2021decreased to $247,814from $5,428,858for the year ended September 30, 2020, a decrease of $5,181,044. The decrease is primarily attributable to the impairment and write off of goodwill and intangible assets of $4,872,354offset by the pace of development of the LSD1 and NPM1 projects which decreased while the direction of the programs were being evaluated based on results achieved so far, along with a decrease in general administrative costs driven by our decreased activity. Net Loss Net loss for the year ended September 30, 2021decreased to $875,998from $5,346,672for the year ended September 30, 2020, a decrease of $4,470,674. The decrease was due to the impairment and write off of goodwill and intangible assets of $4,872,354offset by increases in costs due to the accretion of debt discount and other promissory note costs, decreases in the pace of development of the LSD1 and NPM1 projects which decreased while the direction of the programs are being evaluated, along with a decrease in general administrative costs driven by our decreased activity. 54
Cash and capital resources
November 12, 2019we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $57,500in cash, which we received in November 2019. As at the date of filing this note is in default. The Company is currently negotiating an extension to the maturity date along with amended terms. On February 7, 2020, we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $31,000in cash, which we received in February 2020.
September 22, 2020, we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $35,000in cash, which we received in September 2020. On October 21 2020, we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $40,000in cash, which we received in January 2021. On January 12, 2021, we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $60,000in cash, which we received in January 2021. On February 23, 2021, we entered into a 12% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $90,000in cash, which we received in February 2021. On May 25, 2021, we entered into a 1% Convertible Promissory Note with a Holder pursuant to which we issued a Convertible Promissory Note to the Holder. The Holder provided us with $100,000in cash, which we received in May 2021. We will be required to raise additional capital to continue the development and commercialization of current product candidates and to fund operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we raise additional funds by issuing equity securities, our shareholders may experience significant dilution. Any debt financing, if available, may (i) involve restrictive covenants that impact our ability to conduct, delay, scale back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize its self on unfavorable terms. Capital Resources
The following table summarizes the total current assets, liabilities and working capital for the periods indicated:
September 30, September 30, 2021 2020 Change Current assets
$ 44,577 $ 32,630 $ 11,947Current liabilities $ 2,798,389 $ 2,707,632 $ 91,207Working capital deficiency $ (2,753,812 ) $ (2,675,002 ) $ (78,810 )
We had a cash balance of
55 Liquidity The following table sets forth a summary of our cash flows for the periods indicated: For the For the year ended year ended September 30, September 30, Increase/ 2021 2020 (Decrease)
Net cash used in operating activities
$ (293,393 ) $ (251,327 ) $ (42,066 )Net cash used in investing activities $ - $ - $ - Net cash provided by financing activities $ 290,000$
Net cash used in operating activities was
$293,393for the year ended September 30, 2021compared to $251,327for the year ended September 30, 2020. The change is principally attributable to net loss of $785,082excluding non-cash items such as share based compensation of $42,673, fee charges related to convertible notes of $123,718, Tiziana loan interest of $5,760, accretion of beneficial conversion feature and debt discount of $545,594, a gain on troubled debt restructuring of $11,773and changes in operating assets and liabilities of $32,765for the year ended September 30, 2021as compared to a net loss of $5,346,672excluding non-cash items such as share based compensation of $134,632, an impairment of goodwill and intangible assets of $4,872,354and changes in operating assets and liabilities of $48,320for the year ended September 30, 2020
Net cash provided by financing activities
Net cash provided by financing activities includes proceeds from the issuance of convertible notes of
against proceeds from the issuance of convertible bonds and a related party loan to be paid from
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