ACTAVIA LIFE SCIENCES, INC. - Quarter Report: 2023 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, 2023

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

333-191083

RASNA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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: 771,811,360 shares of common stock were issued and outstanding as of May 15, 2023.

TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

RASNA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED) 

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

RASNA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

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

RASNA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ DEFICIT

(UNAUDITED)

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

RASNA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

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

RASNA THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

1. GENERAL INFORMATION

Rasna Therapeutics, Inc. “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 target LSD1, which is implicated in the disease progression of leukemia and lymphoma.

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.

Risks and Uncertainties

Management continues to evaluate the impact of inflation and the economic environment on the Company, and has concluded that while it is reasonably possible that inflation could have a negative effect on the Company’s financial position, results of its operations and/or ability to secure additional cash resources, there is no current impact as cash resources are currently secured by existing shareholders.

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. There have been no material changes in the Company’s significant accounting policies as compared to the significant accounting policies described in the Company’s annual report on Form 10-K for the Fiscal year ended September 30, 2022.

Basis of preparation

These unaudited condensed consolidated financial statements have been prepared following the requirements of the Securities and Exchange Commission (the “SEC”) and United States generally accepted accounting principles (“US GAAP”) for interim reporting. The principles for condensed interim financial information do not require the inclusion of all the information and footnotes required by generally accepted accounting principles for complete financial statements. Therefore, these condensed consolidated financial statements should be read in conjunction with the consolidated financial statements as of and for the year ended September 30, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on February 9, 2023. The accompanying unaudited condensed consolidated financial statements have not been audited by an independent registered public accounting firm in accordance with the standards of the Public Company Accounting Oversight Board (United States), but in the opinion of management, such financial statements include all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s interim financial information.

The results of the operations for the three and six months ended March 31, 2023 may not be indicative of the results that may be expected for the year ending September 30, 2023.

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiary, Rasna Research Inc, and Rasna Research Inc’s subsidiary, Arna Therapeutics Limited. All significant intercompany accounts and transactions have been eliminated in the preparation of the accompanying consolidated financial statements.

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.

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 income per share includes potentially dilutive securities such as outstanding options, warrants and convertible loan notes, using various methods such as the treasury stock, modified treasury stock, and if converted methods in the determination of dilutive shares outstanding during each reporting period.

Diluted loss per share does not include any common stock equivalents as their effects are anti-dilutive.

The fully diluted earnings per share includes the shares issuable upon the conversion of the outstanding convertible loan notes for the three and six months to March 31, 2022.

The shares issuable on the exercise of options and warrants have been excluded from the computation of diluted weighted average shares outstanding as they would be anti-dilutive.

Recent Accounting Pronouncements

The Company has determined that all other recently issued accounting pronouncements will not have a material impact on its consolidated financial position, results of operations and cash flows, or do not apply to its operations.

3. LIQUIDITY AND 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.

The Company is 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 the Company’s 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.

The Company has experienced net losses and significant cash outflows from cash used in operating activities and as of March 31, 2023, had an accumulated deficit of $28,500,111, a net loss for the six months ended March 31, 2023 of $4,279,044 and net cash used in operating activities of $25,157.

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 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. CONVERTIBLE NOTES

The table below summarizes outstanding convertible notes as of March 31, 2023 and March 31, 2022:

On December 23, 2022, the Company entered into a 16% Convertible Promissory Note with Panetta Partners Ltd. (the “Holder”) pursuant to which the Company issued a Convertible Promissory Note to the Holder. The Holder provided the Company with $30,000 in cash. 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) $0.001 per share or (ii) the price of the next equity financing, which raises at least US $1,000,000, 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.

On January 23, 2023, all outstanding notes with a principal value of $195,000 and accrued interest of $14,773 were converted into 209,773,333 shares with a par value of $0.001.

Embedded Derivative Liability

Under the promissory note agreement, the interest rate will reset upon the event of a default and an additional penalty of 6% will be accrued. The Company analyzed the conversion features of the note agreement for derivative accounting consideration under ASC 815, Derivatives and Hedging, and determined the interest rate resets met the definition of a derivative. It also noted that the Contingent Interest Rate feature required bifurcation from the host note contract and was to be accounted for at fair value. In accordance with ASC 815-15, the Company bifurcated the Contingent Interest Rate feature of the note and recorded a derivative liability.

The embedded derivatives for the notes are carried on the Company’s balance sheet at fair value. During the three and six months ended March 31, 2023, the Company recognized an additional derivative liability of $1,200 due to the issuance of the convertible notes. During the three and six months ended March 31, 2023, the Company recognized a gain on derivative liability of $7,888 and $8,744 due to the conversion of outstanding notes. During the three and six months to March 31, 2022, the Company recognized an additional $3,000 and $71,520 respectively due to the extension and issuance of the convertible notes. During the three and six month period ended March 31, 2022, the Company recognized a gain of $10,114 and $38,969 relating to the issuance and extension of convertible notes.

Beneficial Conversion Feature

The conversion features for all notes issued are in the money as of the issuance date and accordingly a beneficial conversion feature was recorded upon issuance. As the intrinsic value of the beneficial conversion feature exceeds the face value, the recorded beneficial conversion feature was limited to the gross proceeds less any debt discounts. As at March 31, 2023 this amounted to $28,800 for the new notes issued, which was fully amortized upon conversion of the notes. As at March 31, 2022 the beneficial conversion feature amounted to $596,481 for the amended and new notes issued.

5. NOTE PAYABLE

On March 31, 2023, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $53,950. Under the terms of the agreement, the Company made a down payment of $13,500, with the remaining balance financed over the remaining term at an annual percentage rate of 6.99%, resulting in finance charge of $1,187. Beginning in March 2023, the Company is making 9 monthly payments of $4,626, with the last payment made in November 2023. The interest expense for this note payable for the three months ending March 31, 2023 was $236.

On May 15, 2022, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $89,242. Under the terms of the agreement, the Company made a down payment of $10,210, with the remaining balance financed over the remaining term at an annual percentage rate of 7.328%. Beginning in May 2022, the Company is making 8 monthly payments of $10,210, with the last payment made in December 2022. At December 31, 2022, the note was fully paid. The interest expense for this note payable for the three months ending December 31, 2022 was $186.

6. EQUITY

In January 2023, the company issued 209,773,333 shares to Panetta Partners Ltd upon conversion of the outstanding promissory notes and accrued interest.

In March 2023, the Company issued 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company. At the date of issuance this was valued at $3,858,793, based on the issuance date stock price of $0.01 per share. 

7. RELATED PARTY TRANSACTIONS

The following is a summary of the related party transactions for the periods presented.

 Tiziana Life Sciences Plc (“Tiziana”)

The Company is party to a Shared Services Agreement with Tiziana, whereby the Company is charged for shared services and rent. Keeren Shah, the Company’s Chief Financial Officer, is also Chief Financial Officer of Tiziana, and the Company’s directors, Willy Simon and John Brancaccio are also non-executive directors of Tiziana.

As of March 31, 2023 and March 30, 2022, $18,041 and $25,822 respectively was due to Tiziana under services charged under the shared services agreement. This is recorded as a related party payable in the accompanying condensed consolidated balance sheets.

 In March 2020, Tiziana extended a loan facility to Rasna of $65,000. The loan is repayable within 18 months and incurs an interest charge of 8% per annum. In April 2020, the loan facility was extended by a further $7,000, so the loan facility totals $72,000. As of March 31, 2023, the amount due to Tiziana under this loan facility were $89,280. The amount due to Tiziana under this agreement as of March 31, 2022 was $83,520.

In July 2022, Tiziana extended another loan facility to Rasna of $85,000. The loan is repayable within 18 months and incurs an interest charge of 16% per annum. As of March 31, 2023, the amounts due to Tiziana under this loan facility were $98,738. The amount due to Tiziana under this agreement as of September 30, 2022 was $91,967.

Panetta Partners/ Gabriele Cerrone

Panetta Partners Limited, a shareholder of Rasna, is a company in which Gabriele Cerrone is a major shareholder and also serves as a director. As of December 31, 2022, and September 30, 2022, the balance due to Gabriele Cerrone was $175,000 for past consultancy services.

In July 2022, the Company entered into a promissory note with Panetta Partners Ltd for $165,000. The note carries an interest rate of 16% with a conversion price of $0.001 and is due for repayment by December 31, 2024. As at March 31, 2023, $184,580 was due with respect to notes issued. As at September 30, 2022 $171,233 was due with respect to notes issued.

In December 2022, the Company entered into an additional promissory note with Panetta Partners Ltd for $30,000 under the same terms. As at March 31, 2023, $31,307 was due with respect to this note issued.

In January 2023, the company issued 209,773,333 shares to Panetta Partners Ltd upon conversion of the outstanding promissory notes and accrued interest.

In March 2023, the Company issued 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company. At the date of issuance this was valued at $3,858,793 based on the issuance date stock price of $0.01.

Apart from the Convertible Promissory Notes, there is no interest charged on the balances with related parties. There are no defined repayment terms, and such amounts can be called for payment at any time.

Roberto Pellicciari and TES Pharma

Roberto Pellicciari is the majority shareholder of TES Pharma Srl, one of the Company’s principal shareholders. During the three and six months ended March 31, 2023 and March 31, 2022, Roberto Pellicciari did not supply the Company with consulting services.

In March 2022, the Company agreed to return back to TES Pharma S.R.L all intellectual property rights and assignments relating to NPM1. In exchange for this, TES Pharma S.R.L agreed to waive any payments due to them and their affiliates (which includes Roberto Pelliciari) by Rasna. this amounted to a $175,000 gain on the settlement of the related party payable to Roberto Pellicciari and a $150,000 gain on the settlement of accounts payable to TES Pharma and its affiliates. Rasna may be entitled to 20% of any future royalties and/or milestone payments upon successful completion of a clinical Proof of Concept study under certain agreed upon circumstances.

As of March 31, 2023, and September 30, 2022, the balance due to Roberto Pellicciari was $0 for past consultancy services. At March 31, 2023 and September 30, 2022, TES Pharma was owed $0.

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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 Annual Report on Form 10-K filed on February 9, 2023 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.

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.

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.

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”).

Liquidity and 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, 2023, had a working capital deficit of $1,870,275.

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.

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

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 Three months ended March 31, 2023 and 2022

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

Revenues

There were no revenues for the three months ended March 31, 2023, and 2022 because the Company does not have any commercial biopharmaceutical products.

Operating Income/(Expenses)

Operating expenses, consisting of research and development costs, consultancy fees, legal and professional fees and general and administrative expenses, for the three months ended March 31, 2023 increased to $3,966,452 from income of $381,735 for the three months ended March 31, 2022, an increase of $4,348,187. Most of this increase in expenses was due to the issuance of 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company, which at the date of issuance was valued at $3,858,793, offset by a $150,000 and $375,000 gain on the settlement of accounts payable and related party payable, respectively, due to the release of payment obligations to TES Pharma S.R.L and Eurema Consulting S.R.L (and their affiliates) as all intellectual property rights and assignments relating to NPM1 were returned to them by the Company in the three months to March 31, 2022, decreased general and administrative expenditure of $32,086 and decreased research and development patent expenditure of $3,520.

Other expense

During the three months ended March 31, 2023, other expense increased to $162,748 from $87,745 for the three months ended March 31, 2022. This increase is predominantly due to additional expenses of $86,994 due to the acceleration in the accretion of debt discount charges driven by the conversion of the outstanding notes in January 2023, a reduction in the gain on derivative liability of $2,226 offset by savings on interest expense of $14,217.

Net loss

Net loss for the three months ended March 31, 2023 increased to $4,129,200 from a net income of $293,990 for the three months ended March 31, 2022, a change of $4,423,190. This is predominantly due to the issuance of 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company, which at the date of issuance was valued at $3,858,793, additional expenses of $86,994 due to the acceleration in the accretion of debt discount charges driven by the conversion of the outstanding notes in January 2023, a reduction in the gain on derivative liability of $2,226 offset by a one off $150,000 and $375,000 gain on the settlement of accounts payable and related party payable, respectively, due to the release of payment obligations to TES Pharma S.R.L and Eurema Consulting S.R.L (and their affiliates) as all intellectual property rights and assignments relating to NPM1 were returned to them by the Company in the three months to March 31, 2022, decreased general and administrative expenditure of $32,086, decreased research and development patent expenditure of $3,520 and savings on interest expense of $14,217.

Results of Operations for the Six months ended March 31, 2023 and 2022

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, 2023, and 2022 because the Company does not have any commercial biopharmaceutical products.

Operating Income/(Expenses)

Operating expenses, consisting of research and development costs, consultancy fees, legal and professional fees and general and administrative expenses, for the three months ended March 31, 2023 increased to $4,089,264 from income of $299,944 for the three months ended March 31, 2022, an increase of $4,389,208. Most of this increase in expenses was due to the issuance of 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company, which at the date of issuance was valued at $3,858,793, increased general and administrative expenditure of $114, increased research and development patent expenditure of $5,301 offset by a $150,000 and $375,000 gain on the settlement of accounts payable and related party payable, respectively, due to the release of payment obligations to TES Pharma S.R.L and Eurema Consulting S.R.L (and their affiliates) as all intellectual property rights and assignments relating to NPM1 were returned to them by the Company in the three months to March 31, 2022.

Other expense

During the six months ended March 31, 2023, other expense decreased to $189,780 from $280,585 for the six months ended March 31, 2022. This decrease is predominantly due to a decrease of $100,220 in the accretion of debt discount charges, savings in interest expenses of $20,810 offset by a reduction in the gain on derivative liability of $30,225.

Net loss

Net loss for the six months ended March 31, 2023 increased to $4,129,200 from a net income of $293,990 for the three months ended March 31, 2022, a change of $4,423,190. This is predominantly due to the issuance of 382,058,666 shares to Panetta Partners Ltd as consideration for their continued financial support of the company, which at the date of issuance was valued at $3,858,793, increased general and administrative expenditure of $114, increased research and development patent expenditure of $5,301, a reduction in the gain on derivative liability of $30,225 offset by a one off $150,000 and $375,000 gain on the settlement of accounts payable and related party payable, respectively, due to the release of payment obligations to TES Pharma S.R.L and Eurema Consulting S.R.L (and their affiliates) as all intellectual property rights and assignments relating to NPM1 were returned to them by the Company in the three months to March 31, 2022, a decrease of $100,219 in the accretion of debt discount charges, and savings in interest expenses of $20,811.

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 December 23, 2022, the Company entered into a 16% Convertible Promissory Note again with Panetta Partners Ltd. (the “Holder”) pursuant to which the Company issued a Convertible Promissory Note to the Holder. The Holder provided the Company with $30,000 in cash under the same terms as the fifteenth note. Both notes were converted on January 23, 2023.

Capital Resources

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

We had a cash balance of $2,221 and $39,363 on March 31, 2023, and September 30, 2022, 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 $25,157 for the six months ended March 31, 2023 compared to $142,770 for the six months ended March 31, 2022. The net loss of $4,279,044 for the six months ended March 31, 2023 was partially offset primarily by the non-cash issuance of support consideration settled in stock of $3,858,793, a gain on derivative liability of $8,744 adjusted for accretion of debt discount of $180,333, interest expense of $18,191 and changes in operating assets and liabilities of $206,314.

Net Cash Provided by Financing Activities

Net cash provided by financing activities consists of proceeds from the issuance of convertible notes of $30,000 offset by payments for on a note payable of $41,985 for the six months ended March 31, 2023 compared to proceeds from the issuance of convertible notes of $160,000 for the six months ended March 31, 2022.

ITEM 3. CONTROLS AND PROCEDURES

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, 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, the Chief Executive 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

ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in our Annual Report on Form 10-K/A as of and for the year ended September 30, 2022, filed with the SEC on February 9, 2023.

ITEM 6. EXHIBITS

Signatures

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.

17