ACTAVIA LIFE SCIENCES, INC. - Quarter Report: 2020 March (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended March 31, 2020

 

OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Transition Period from ___ to ___

 

Commission file number

 

RASNA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada	39-2080103
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

  

420 Lexington Ave, Suite 2525, New York, NY 10170

(Address of principal executive offices)   (Zip Code)

 

Telephone: (646) 396-4087

(Registrant’s telephone number)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days.   Yes ☒   No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes ☐    No ☒

Securities registered pursuant to Section 12(b) of the Act: None

  

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 68,908,003  shares of common stock were issued and outstanding as of June 29, 2020.

EXPLANATORY NOTE

This Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 is being filed pursuant to the order of the Securities and Exchange Commission contained in SEC Release No. 34-88465, dated March 25, 2020 (the “Order”). We filed a Form 8-K on April 24, 2020, indicating our reliance on the relief granted by the Order and the necessity to rely on such relief due to circumstances related to COVID-19 pandemic. In particular, the COVID-19 pandemic has caused severe disruptions in access to our facilities, resulting in limited support from our staff, as well as disruptions in the focus of our management that has dedicated time and resource to mitigating the effects of the pandemic. These effects, in turn, delayed our ability to file this Quarterly Report on its original due date.

  

TABLE OF CONTENTS

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		PAGE
PART 1	FINANCIAL INFORMATION
ITEM 1.	FINANCIAL STATEMENTS	3
	Condensed Consolidated Balance Sheets - March 31,2020 (unaudited) and September 30, 2019	3
	Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended March 31, 2020 and 2019	4
	Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Six Months Ended March 31, 2020 and 2019	5
	Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended March 31, 2020 and 2019	6
	Notes to the Condensed Consolidated Financial Statements	7
ITEM 2.	Management’s discussion and analysis of financial condition and results of operations	16
ITEM 3.	Quantitative and qualitative disclosures about market risk	21
PART II	OTHER INFORMATION
ITEM 1A	Risk factors	22
ITEM 6.	Exhibits	22
SIGNATURES		23

PART I – FINANCIAL INFORMATION 

 

 

RASNA THERAPEUTICS, INC.

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

RASNA THERAPEUTICS, INC.

 

(UNAUDITED)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 

 

RASNA THERAPEUTICS, INC.

 

(UNAUDITED)

 

    

   

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

RASNA THERAPEUTICS, INC.

 

(UNAUDITED)

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 RASNA THERAPEUTICS, INC.

 

(UNAUDITED)

 

1.    GENERAL INFORMATION

Rasna Therapeutics, Inc. (“Rasna DE", "Rasna Inc.” or the "Company"), is a biotechnology company incorporated in the State of Delaware on March 28, 2016. The Company is engaged in modulating the molecular targets NPM1 and LSD1, which are implicated in the disease progression of leukemia and lymphoma. 

 

On April 27, 2016, Rasna Therapeutics Limited, a private limited company incorporated in England and Wales under the U.K. Companies Act (“Rasna UK”) sold its stake in Falconridge Holdings Limited, or Falconridge, to Rasna DE for  $1. Falconridge had no operations, assets or liabilities as of this date.

 

On May 17, 2016, Rasna DE and  Falconridge entered into an Agreement of Merger and Plan of Reorganization (the “Merger Agreement”) with Arna Therapeutics Limited, a British Virgin Islands company, or Arna, which was a clinical stage biotechnology company focused on drugs to treat diseases in oncology and immunology, mainly focusing on the treatment of leukemia. Pursuant to the Merger Agreement, Arna was merged into Falconridge and the shareholders of Arna were issued shares of Rasna DE in exchange for shares of Arna.

 

On August 15, 2016, Active With Me, Inc., or AWM, entered into an Agreement of Merger and Plan of Reorganization with Rasna DE, and Rasna Acquisition, providing for the merger of Rasna Acquisition with and into Rasna DE, (the “Merger”), with Rasna DE, surviving the Merger as a wholly owned subsidiary of AWM. 

 

The Merger was treated as a reverse recapitalization effected by a share exchange for financial accounting and reporting purposes since substantially all of AWM’s operations were disposed of prior to the consummation of the transaction.  Rasna DE was treated as the accounting acquirer as its shareholders control the Company after the Merger and  AWM was treated as the legal acquirer.  As a result of the Merger, the assets and liabilities and the historical operations that are reflected in the financial statements are those of Rasna DE as if Rasna DE had always been the reporting company. Since the transaction was treated as a reverse recapitalization for financial accounting and reporting purposes, no goodwill or other intangible assets were recorded by the Company.

 

These unaudited condensed consolidated financial statements are presented in United States dollars (“USD”) which is also the functional currency of the primary economic environment in which the Company operates. See Note 2, foreign currency policy. 

 

2.    ACCOUNTING POLICIES

 

The principal accounting policies applied in the preparation of these unaudited condensed consolidated financial statements are set out below. These policies have been applied consistently to all the periods presented unless otherwise stated.

 

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. The Company evaluates its estimates on an ongoing basis, including those related to the fair values of share based awards, income taxes and contingent liabilities, among others. The Company bases its estimates on historical experience and on various other assumptions that the Company believes to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates and such differences could be material to the Company's consolidated financial position and results of operations.

 

 

 

 

3.    GOING CONCERN

 

The Company has no present revenue and has experienced net losses and significant cash outflows from cash used in operating activities since inception, and at March 31, 2020, had an accumulated deficit of $(17,660,824), a net loss for the six months ended March 31, 2020 of $(349,015) and net cash used in operating activities of $(217,623) for the  six months ended March 31, 2020.

 

The Company expects to continue to incur net losses and have significant cash outflows for at least the next 12 months and will require significant additional cash resources to launch new development phases of existing products in its pipeline.

 

In the event that the Company is unable to secure the necessary additional cash resources needed, the Company may slow current development phases or halt new development phases in order to mitigate the effects of the costs of development. These conditions, among others, raise substantial doubt about the Company's ability to continue as a going concern for a period of one year from the date of this filing. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern one year from the date of this filing. This basis of accounting contemplates the recovery of the Company's 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 the Company's cost structure.

4.    GOODWILL AND INTANGIBLE ASSETS

On May 17, 2016, the Company acquired an entity and, at initial purchase price, it was determined that there was $236,269 of intellectual property, $613,100 of in-process research and development ("IPR&D") and $2,722,985 of goodwill.

 

Goodwill

 

Goodwill represents the excess of the purchase price over the fair value of net assets acquired in business combinations accounted for under the purchase method of accounting. The following table summarizes the Company’s goodwill for the periods indicated resulting from the acquisitions by the Company:

	March 31,				September 30,
	2020				2019
Goodwill	$	2,722,985			$	2,722,985

 

The Company performed an impairment analysis and no impairment was determined. Therefore, no impairment was recorded as of March 31, 2020 and September 30, 2019.

 

Intangible Assets

 

On December 17, 2013 one of the Company’s shareholders, Panetta Partners Limited, transferred 5,000,000 of its shares in Arna Therapeutics Limited to Eurema Consulting S.r.l. and 5,000,000 shares in Arna Therapeutics Limited to TES Pharma S.r.l. In exchange for the shares, Panetta Partners Limited obtained intellectual property ("Platform Technology") from TES Pharma S.r.l and Eurema Consulting S.r.l. Panetta Partners Limited then assigned the Platform Technology to Arna Therapeutics Limited, which was accounted for as a capital contribution. The fair value of the shares exchanged for the IPR&D was $0.13 per share; in addition the issue price for shares issued in October 2013 was $0.13 per share (shares issued post acquisition of the IPR&D were issued at $0.28) and accordingly the Company valued the Platform Technology at $1.3 million.

On May 5, 2016, Rasna UK sold its intellectual property to Falconridge for a note payable in the amount of $236,269. Rasna UK is considered a VIE and consolidated in these financial statements, however, is not an entity under common control as Rasna controlled both Falconridge and Rasna UK at the time of the transaction, this transaction eliminates on consolidation.

 

The Company retained a Clinical Research Organisation ("CRO") to perform all related research and development associated with IPR&D related to LSD‐1. Pursuant to the terms of of the license agreement dated January 1, 2015, between the CRO and Rasna, the Company agreed to pay approximately $111,000 (EUR 100,002) for costs incurred to date and to perform research and development on a going forward basis. Additionally, the Company entered into an amended license agreement whereby Rasna agreed to pay the CRO an additional amount of approximately $502,000,  (EUR 435,000) as of May 17, 2016, regarding services rendered between September 9, 2014 to May 17, 2016. Based on the cost approach, the IPR&D was fair valued at $613,100.

 

At the time of the acquisition, the Company had reasonably expected to use the Platform Technology, in the asset’s then current state, in two independent research projects that had not commenced as of the date of the acquisition. The Company’s research projects applied the conclusions reached in the Platform Technology to develop treatments for acute myeloid leukemia ("AML") through reformulation of certain available pharmaceuticals and independent development of a new pharmaceutical treatment. Both research projects were initiated shortly after the Platform Technology was acquired and continue through the date of the financial statements.

 

At the time of acquisition, and at present, no legal, regulatory, contractual, competitive, economic, or other factors were present that would constrain the useful life of the asset to the Company. The agreement to purchase the asset has no provisions that would limit the timeframe of use, legally, contractually or economically, and the asset remains a competitive platform for results in the treatment of AML and lymphoma. Specifically, the agreement irrevocably assigns all rights and title to the asset, without limitation or contingencies. No limitations or alternative technology has emerged that would suggest obsolescence or a change in the competitive landscape for the Platform Technology as of the most recent reporting period. In addition, the Company has concluded that the useful life of the Platform Technology at the time of acquisition was beyond a foreseeable horizon, and therefore the asset is classified as an indefinite lived intangible asset.

 

The IPR&D and intellectual property are considered to have indefinite lives and there were no impairment charges recognized during the six months ended March 31, 2020 or the year ended September 30, 2019.

 

The following table summarizes the Company’s intangible assets as of the following periods: 

 

5.    SHARE-BASED COMPENSATION

2016 EQUITY INCENTIVE PLAN

 

On July 19, 2016, the Company adopted its 2016 Equity Incentive Plan (the "Equity Incentive Plan"). The Equity Incentive Plan was established to attract, motivate, retain and reward selected employees and other eligible persons. For the Equity Incentive Plan, employees, officers, directors and consultants who provide services to the Company or one of the Company’s subsidiaries may be selected to receive awards. A total of 9,750,000 shares of the Company’s common stock was authorized for issuance with respect to awards granted under the Equity Incentive Plan.

Share-based compensation expense is the estimated fair value of options granted amortized on a straight-line basis over the requisite service period for the entire portion of the award less an estimate for anticipated forfeitures. The Company uses the “simplified” method to estimate the expected term of the options because the Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. No options were granted during the six months ended March 31, 2020 and 2019.

 

The fair value of stock options was valued using the Black-Scholes option pricing model, which was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company's stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of the Company's stock options.

 

The following table summarizes stock option activity for the six months ended March 31, 2020:

  

As of March 31, 2020, there was $87,625 of total unrecognized compensation cost related to stock options. The cost is expected to be recognized over a weighted average period of 1.05 years.

For the three and six months ended March 31, 2020 $42,508 and $89,681, respectively,  related to share based compensation to directors and employees respectively, has been included within the general and administrative expense category in the accompanying unaudited condensed consolidated interim financial statements. No costs related to non-employees have been included within the consultancy fees expense category in the unaudited condensed consolidated interim financial statements. 

For the three and six months ended March 31, 2019 $107,140 and $226,157 , respectively, related to share based compensation to directors and employees respectively, has been included within the general and administrative expense category in the accompanying unaudited condensed consolidated interim financial statements. An additional $(14,689) and $(5,470) related to decreases in the fair value of awards granted to non-employees for the three and six months ended March 31, 2019, for respectively, has been included within the consultancy fees expense category in the accompanying unaudited condensed consolidated interim financial statements. 

 

6.    CONVERTIBLE NOTES

 

On August 8, 2018, the Company entered into a 12% Convertible Promissory Note with High Octane Bioresearch Ltd. (the “Holder”) pursuant to which the Company issued a Convertible Promissory Note to the Holder. The Holder provided the Company with $135,000 in cash, which was received by the Company during the year ended September 30, 2019. The Company promised to pay the principal amount, together with guaranteed interest at the annual rate of 12%, with principal and accrued interest on the Note due and payable on August 9, 2019 (unless converted under terms and provisions as set forth within the Agreement). The Note provides the Holder with the right to convert, at any time, all or any part of the outstanding principal and accrued but unpaid interest into shares of the Company’s common stock at a conversion price equal to the lower of (i) $0.65 per share or (ii) the price of the next financing during the 180 days after the date of the Agreement, subject to adjustments noted within the Agreement. The number of shares issuable upon a conversion shall be determined by the quotient obtained by dividing (x) the outstanding principal amount of the Note to be converted by (y) the Conversion Price. The Note requires the Company to reserve and keep available out of its authorized and unissued shares of common stock the amount of shares that would be issued upon conversion of the Note, which includes the outstanding principal amount of the Note and interest accrued and to be accrued through the date of maturity.  

In relation to the Convertible Promissory Note, the Company has also entered into an agreement with Garcer Bioventures, a broker who introduced the Holder to the Company. Under the terms of this agreement, should the Holder convert its principal amount into common stock of the Company, the Company will issue to Garcer Bioventures the number of shares equal to 10% of the number of shares of common stock issued to High Octane upon such conversion. 

 

On October 19, 2018, the Company entered into a second 12% Convertible Promissory Note with the Holder with a maturity date of October 19, 2019. The Holder provided the Company with $100,000 in cash, which was received by the Company during the three months ended December 31, 2018, under the same terms as the first Note. The Company has also entered into another agreement with Garcer Bioventures in lieu of fees, under the same terms as the earlier agreement.

In July 2019, the Company extended the maturity dates of the Convertible Promissory Notes from August 8, 2019 and October 19, 2019 to August 8, 2020 and October 19, 2020, respectively. All other terms of the Convertible Promissory Notes remained the same.  The Amended Convertible Promissory Notes were accounted for as a modification of the original Convertible Promissory Notes as the change in the fair value of the embedded conversion option featured in the Convertible Promissory Notes immediately before and after the amendment did not exceed 10% of the carrying amount of the Convertible Promissory Notes.

On November 12, 2019, the Company entered into a third 12% Convertible Promissory Note with the Holder with a maturity date of November 12, 2020. The Holder provided the Company with $57,500 in cash, which was received by the Company during the three months ended December 31, 2019, under the same terms as the earlier Notes. 

In February 2020, the Company entered into a fourth 12% Convertible Promissory Note with the Holder with a maturity date of February 7, 2021. The Holder provided the Company with $31,000 in cash, which was received by the Company during the three months ended March 31, 2020, under the same terms as the earlier Notes. 

 

In March 2020, the Company entered into a fifth 12% Convertible Promissory Note with the Holder with a maturity date of March 20, 2021. The Holder provided the Company with $20,000 in cash, which was received by the Company during the three months ended March 31, 2020, under the same terms as the earlier Notes. 

At March 31, 2020, there were 528,461 shares reserved for the conversion of the Notes and 36,153 shares were reserved in lieu of fees due to Garcer Bioventures. 

Interest expense associated with the convertible notes was $18,154 and $— for the six months ended March 31, 2020 and 2019 respectively.

 

7.    RELATED PARTY TRANSACTIONS

8.    COMMITMENTS AND CONTINGENCIES

License Agreements

 

In November 2016, the Company entered into a license agreement with Profs. Falini and Martelli, wherein it obtained the exclusive rights related to the use or reformulation of Actinomycin D (Act D; a.k.a. Dactinomycin) and intends to utilize these rights for the development of new product. In connection with this agreement, the Company was committed to paying milestone payments, the first being a $57,046 ( EUR 50,000) payment to be paid six months after the agreement was signed. The payment was made to Profs. Falini and Martelli in June 2017.

The specific timing of the remaining milestones cannot be predicted and depends upon research and clinical developments. None of the milestones have been reached as at the date of these unaudited financial statements. See Note 9 Subsequent events regarding the sale of  Actinomycin D.

Lease Agreements

In February 2018, the Company renewed its lease agreement with the same terms, with Bucks County Biotechnology Centre Inc. in Doylestown Pennsylvania, where certain employees of the Company are based. The lease provided for annual basic lease payments from February 1, 2019 to January 31, 2020 of $13,480, plus utility expense of $237 per month. The Company did not renew this lease after January 31, 2020.

During the six months ended March 31, 2020, the Company did not incur any rental expenses related to this agreement as these costs were recharged to Tiziana under the shared services agreement.

 

 

Consultancy Agreements

 

In October 2016, the Company entered into a consultancy agreement with Tiziano Lazzaretti in which he agreed to serve as Chief Financial Officer for a fee of  $50,000 per year. This was increased to $80,000 a year in April 2017 by the Company's compensation committee. During the six months ended March 31, 2020 the Company incurred approximately $40,000 of consultancy expenses related to this agreement. 

Shared Services Agreement

 

The Company has entered into a shared services agreement with Tiziana. Under the terms of this agreement, the Company will be charged for shared services including payroll and rent for the Lexington Avenue premises, on a monthly basis based on allocated costs incurred. This agreement became effective from January 1, 2017.  (see Note 7). Tiziana has agreed to waive all charges for shared services from October 2018 onwards, until further notice.

Other Commitments

 

The Company may enter into certain licensing agreements for products currently under development. The Company may be obligated in future periods to make additional payments, which would become due and payable only upon the achievement of certain research and development, regulatory, and approval milestones. The specific timing of such milestones cannot be predicted and depend upon future discretionary research and clinical developments, as well as, regulatory agency actions. Further, under the terms of certain agreements, the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not considered contingent milestone payment amounts.

 

9.    SUBSEQUENT EVENTS

On April 16, 2020, the Company entered into an asset purchase agreement with Tiziana pursuant to which the Company agreed to sell all of the intellectual property relating to a nanoparticle-based formulation of Act D to Tiziana in exchange for an upfront payment of $120,000 and milestone payments of up to an aggregate $630,000.

 

Forward-Looking Statements 

 

This section and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Forward-looking statements can also be identified by words such as “future,” “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “will,” “would,” “could,” “can,” “may,” and similar terms. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in the Company’s Transitional Report on Form 10-K filed on January 13, 2020 under the heading “Risk Factors,” which are incorporated herein by reference.

 

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 indicated or the context requires otherwise, the terms "Rasna,",” the “Company,” “we,” “us,” and “our” refer to Rasna Therapeutics, Inc., a Nevada corporation, and, where appropriate, its wholly owned subsidiaries.

 

Company Background

 

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 and convertible notes.

 

We anticipate that our expenses will increase substantially if and as we:

 

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.

 

On May 17, 2016, Rasna DE and its subsidiary Falconridge Holdings Ltd, or Falconridge, entered into an Agreement of Merger and Plan of Reorganization (“Merger Agreement”) with Arna Therapeutics Limited, a British Virgin Islands company, or Arna, which was a clinical stage biotechnology company focused on drugs to treat diseases in oncology and immunology, mainly focusing on the treatment of leukemia. Pursuant to the Merger Agreement, Arna was merged into Falconridge and the shareholders of Arna were issued shares of Rasna DE in exchange for shares of Arna.

 

On August 15, 2016, Active With Me, Inc., or AWM, entered into an Agreement of Merger and Plan of Reorganization with Rasna DE, and Rasna Acquisition, providing for the merger of Rasna Acquisition with and into Rasna DE, (the “Merger”), with Rasna DE, surviving the Merger as a wholly-owned subsidiary of AWM. As a result of the Merger, the resulting company, Rasna Therapeutics, Inc., is a biotechnology company that is engaged in modulating the molecular targets NPM1 and LSD1, which are implicated in the disease progression of leukemia and lymphoma.

 

The Merger was treated as a reverse recapitalization effected by a share exchange for financial accounting and reporting purposes since substantially all of AWM’s operations were disposed of prior to the consummation of the transaction.  Rasna DE was treated as the accounting acquirer as its shareholders control the Company after the Merger, even though AWM was the legal acquirer.  As a result, the assets and liabilities and the historical operations that are reflected in our financial statements are those of Rasna DE as if Rasna DE had always been the reporting company. Since AWM had no operations upon the Merger taking place, the transaction was treated as a reverse recapitalization for accounting purposes and no goodwill or other intangible assets were recorded by the Company as a result of the Merger Agreement.

 

We only have one segment of activity, which is that of a biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, mainly focusing on the treatment of leukemia and lymphoma.

The Company is currently looking into raising funds to progress its R&D pipeline.

 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America, or US 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 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 unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly 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 financial statements have been prepared in conformity with 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 (“the FASB”).

 

Going Concern

 

We are subject to a number of risks similar to those of other pre-commercial stage companies, including our 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 our development activities and generating a level of revenues adequate to support our cost structure.  

 

We have no present revenue and have experienced net losses and significant cash outflows from cash used in operating activities since inception, and at March 31, 2020, had an accumulated deficit of $17,660,824, a net loss for the six months ended March 31, 2020 of $349,015 and net cash used in operating activities of $217,623 for the six months ended March 31, 2020.

 

We expect to continue to incur net losses and have significant cash outflows for at least the next twelve months and will require significant additional cash resources to launch new development phases of existing products in its pipeline. In the event that the Company is unable to secure the necessary additional cash resources needed, we may slow current development phases or halt new development phases in order to mitigate the effects of the costs of development. These conditions, among others, raise substantial doubt about our ability to continue as a going concern one year from the date of this filing. The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern one year from the date of this filing. 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.

Results of Operations

 

The following paragraphs set forth our results of operations for the periods presented.  The period-to-period comparison of financial results is not necessarily indicative of future results.

Results of Operations for the Six Months Ended March 31, 2020 and 2019

 

The following table sets forth the summary statements of operations for the periods indicated:

 

Revenues

 

There were no revenues for the six months ended March 31, 2020 and 2019 because the Company does not have any commercial biopharmaceutical products.

Operating Expenses

 

Operating expenses consisting of, research and development costs, consultancy fees, legal and professional fees and general and administrative expenses for the six months ended March 31, 2020 decreased to $330,861 from $662,618 for the six months ended March 31, 2019, a decrease of $331,757. The decrease is primarily attributable to a reduction in payroll and travel expenses reflecting the decreased activity in the Company (approximately $145,000), the absence of any R&D related activities (approximately $75,000), a reduction in professional fees relating to patent costs ($30,000), and a decrease in fees for legal and payroll services ($80,000). This is a result of the Company having insufficient cash resources to fund its operations.

Net Loss

Net loss for the six months ended March 31, 2020 decreased to $349,015 from $666,664 for the six months ended March 31, 2019, a decrease of $317,649. The decrease is primarily attributable to a reduction in payroll and travel expenses reflecting the decreased activity in the Company (approximately $145,000), the absence of any R&D related activities in the quarter (approximately $75,000), a reduction in professional fees relating to patent costs ($30,000), a decrease in fees for legal and payroll services ($80,000), partially offset by an increase in the interest accrued for convertible loan notes of approximately $18,000 . This is a result of the Company having insufficient cash resources to fund its operations.

  

 

Liquidity and Capital Resources 

 

We believe we will require significant additional cash resources to continue to launch new development phases of existing products in the Company's pipeline. In the event that we are unable to secure the necessary additional cash resources needed, we may slow current development phases or halt new development phases in order to mitigate the effects of the costs of development. These conditions, among others, raise substantial doubt about our ability to continue as a going concern. A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support our cost structure. 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. 

 

On November 12, 2019, we issued  a 12% convertible promissory note (the “Note”) to an investor, in the principal amount of $57,500 with a maturity date of November 12, 2020. The Note  is convertible by the holder at any time into shares of our common stock at a conversion price equal to the lower of (i) $0.65 per share or (ii) the price of the next financing during the 180 days after the date of the Note. If the holder has not converted the Note into common stock by the maturity date, we must repay the outstanding principal amount plus accrued interest.  

On February 07, 2020, we issued  a 12% convertible promissory note (the “Note”) to an investor, in the principal amount of $31,000 with a maturity date of February 07, 2021. The Note  is convertible by the holder at any time into shares of our common stock at a conversion price equal to the lower of (i) $0.20 per share or (ii) the price of the next financing during the 180 days after the date of the Note. If the holder has not converted the Note into common stock by the maturity date, we must repay the outstanding principal amount plus accrued interest.  

On March 20, 2020, we issued  a 12% convertible promissory note (the “Note”) to an investor, in the principal amount of $20,000 with a maturity date of March 20, 2021. The Note  is convertible by the holder at any time into shares of our common stock at a conversion price equal to the lower of (i) $0.20 per share or (ii) the price of the next financing during the 180 days after the date of the Note. If the holder has not converted the Note into common stock by the maturity date, we must repay the outstanding principal amount plus accrued interest.  

All Notes contain an anti-dilution provision, which adjusts the conversion price in the event of an issuance by us of common stock below the then effective conversion price.

On April 16, 2020, we entered into an asset purchase agreement with Tiziana pursuant to which we agreed to sell all of the intellectual property relating to a nanoparticle-based formulation of Act D to Tiziana in exchange for an upfront payment of $120,000 and milestone payments of up to an aggregate $630,000.

 

Capital Resources

 

The following table summarizes total current assets, liabilities and working capital as of the periods indicated:

 

We had a cash balance of $5,945 and $50,068 at March 31, 2020 and September 30, 2019, respectively. 

 

Liquidity

 

The following table sets forth a summary of our cash flows for the periods indicated:

 

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities consists of net loss adjusted for the effect of changes in operating assets and liabilities.

 

Net cash used in operating activities was $217,623 for the six months ended March 31, 2020 compared to $100,280 for the six months ended March 31, 2019. The net loss of $349,015 for the six months ended March 31, 2020 was partially offset primarily by non-cash share based compensation of $89,681, interest accrued on the Convertible Loan Notes of $18,154 and changes in operating assets and liabilities of $22,740. The net loss of $666,664 for the six months ended March 31, 2019, was partially offset by non-cash items such as share based compensation of  $220,687, depreciation expense of $2,654 and changes in operating assets and liabilities of $334,898.

Net Cash Provided by Financing Activities

Net cash provided by financing activities consists of proceeds from the issuance of a convertible note of  $173,500 and a related party loan payable of $65,000 for the six months ended March 31, 2020 compared to $100,000 of proceeds from the issuance of a convertible note during the six months ended March 31, 2019.

Off-Balance Sheet Arrangements

We consolidate variable interest entities (“VIE”) in which we hold a controlling financial interest as evidenced by the power to direct the activities of a VIE that most significantly impact its economic performance and the obligation to absorb losses of, or the right to receive benefits from, the VIE that could potentially be significant to the VIE and therefore are deemed to be the primary beneficiary. We take into account our entire involvement in a VIE (explicit or implicit) in identifying variable interests that individually or in the aggregate could be significant enough to warrant our designation as the primary beneficiary and hence require us to consolidate the VIE or otherwise require us to make appropriate disclosures. 

 

 

Evaluation of Disclosure Controls and Procedures

 

We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This term refers to the controls and procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized, and reported within the required time periods. In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

As of the end of the period covered by this Report, the Company’s Chief Executive Officer and Chief Financial Officer (the “Certifying Officers”), evaluated the effectiveness of the Company’s “disclosure controls and procedures,” as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. Based on that evaluation, each officer concluded that, as of the date of the evaluation, the Company’s disclosure controls and procedures were not effective to provide reasonable assurance that the information required to be disclosed in the Company’s periodic filings under the Securities Exchange Act of 1934 is accumulated and communicated to management to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act) during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II – OTHER INFORMATION

 

 

Except for the following risk factor, there have been no material changes from the risk factors disclosed in our Form 10-K as of and for the year ended September 30, 2019. 

The ongoing COVID-19 pandemic may, directly or indirectly, adversely affect our business, results of operations and financial condition.

Our business could be materially adversely affected, directly or indirectly, by the widespread outbreak of contagious disease, including the ongoing COVID-19 pandemic, which has spread to many of the countries in which we, our suppliers and our collaboration partners do business. National, state and local governments in affected regions have implemented and may continue to implement safety precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter in place orders and shutdowns, business closures, cancellations of public gatherings and other measures. Organizations and individuals are taking additional steps to avoid or reduce infection, including limiting travel and staying home from work. These measures are disrupting normal business operations both in and outside of affected areas and have had significant negative impacts on businesses and financial markets worldwide.

We continue to monitor our operations and applicable government recommendations, and we have made some modifications to our normal operations because of the COVID-19 pandemic, including requiring most office-based support staff to work remotely. Notwithstanding these measures, the COVID-19 pandemic could affect the health and availability of our support staff as well as those of the third parties we rely on taking similar measures. We also recognize that the global economic climate may impact our ability to raise funds. 

  

10.1		Asset Purchase Agreement between Rasna Therapeutics, Inc. and Tiziana Life Sciences plc dated April 16, 2020
31.1*		Certification of Principal Executive Officer and Principal Financial and Accounting Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
32.1*		Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
101.INS*		XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
101.SCH*		XBRL Taxonomy Schema Document
101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB*		XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF*		XBRL Taxonomy Extension Definition Linkbase

 

* Filed Herewith

 

 

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Rasna Therapeutics, Inc.
June 29, 2020	By:	/s/ Tiziano Lazzaretti
		Name: Tiziano Lazzaretti Title: Chief Financial Officer, (Principal Executive Officer and Principal Financial and Accounting Officer)