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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 June 30, 2022

 

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: 000-56257

 

ACCUSTEM SCIENCES, INC.

(Exact name of registrant as specified in Its Charter)

 

Delaware   87-3774438

(State of other jurisdiction of

incorporation or organization)

  

(I.R.S. Employer

Identification No.)

 

5 Penn Plaza, 19th Floor, #1954 New York, NY   10001
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: 00 44 2074952379

 

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

 

Securities registered pursuant to Section 12(g) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   ACUT   OTCQB Venture Marketplace (“OTCQB”)

 

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 (or for such shorter period that the registrant was required to file such reports), 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, every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐

 

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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.

 

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
    Emerging growth company ☒

 

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 Exchange Act). Yes ☐ No ☒

 

As of August 12, 2022, there were 11,337,571 shares of Common Stock, $0.001 par value outstanding.

 

 

 

 

 

 

Table of Contents

 

    Page
Special Note Regarding Forward-Looking Statements and Other Information Contained in this Report ii
     
PART I- FINANCIAL INFORMATION 1
     
Item 1. Financial Statements 1
     
  Condensed Consolidated Balance Sheets as of June 30, 2022 (Unaudited) and December 31, 2021 1
     
  Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021 2
     
  Unaudited Condensed Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 2021 3
     
  Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021 5
     
  Notes to Unaudited Condensed Consolidated Financial Statements 6
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 19
     
Item 4. Controls and Procedures 19
     
PART II - OTHER INFORMATION 21
     
Item 1. Legal Proceedings 21
     
Item 1A. Risk Factors 21
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 21
     
Item 3. Defaults Upon Senior Securities 21
     
Item 4. Mine Safety Disclosures 21
     
Item 5. Other Information 21
     
Item 6. Exhibits 22
     
SIGNATURES 23

 

i

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION

CONTAINED IN THIS REPORT

 

This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or the negative thereof or other variations thereon or other comparable terminology. All statements other than statements of historical facts included in this Form 10-Q regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements we make regarding: expectations for revenues, cash flows and financial performance and the anticipated results of our ongoing development and business strategies.

 

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, but are not limited to, the following:

 

  ● the success, cost and timing of our clinical development of our products, including the progress of, and results from, our preclinical and
  ● clinical trials of StemPrintER and MSC products, our discovery programs and other potential product candidates;
  ● our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved;
  ● our ability to compete with companies currently marketing or engaged in the development of treatments for indications that our product candidates are designed to target;
  ● our plans to pursue research and development of other future product candidates;
  ● the potential advantages of our product candidates and those being developed;
  ● the rate and degree of market acceptance and clinical utility of our product candidates;
  ● the success of our collaborations and partnerships with third parties;
  ● our estimates regarding the potential market opportunity for our product candidates;
  ● our sales, marketing and distribution capabilities and strategy;
  ● our ability to establish and maintain arrangements for manufacture of our product candidates;
  ● our intellectual property position;
  ● our expectations related to the use of capital;
  ● the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and future clinical trials;
  ● our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
  ● the impact of government laws and regulations; and
  ● our competitive position.

 

The forward-looking statements are based upon management’s beliefs and assumptions and are made as of the date of this report. We undertake no obligation to publicly update or revise any forward-looking statements included in this report. You should not place undue reliance on these forward-looking statements.

 

This report also contains or may contain estimates, projections and other information concerning our industry and our business, including data regarding the estimated size of our markets and their projected growth rates. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, studies and similar data prepared by third parties, industry and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which these data are derived.

 

Unless otherwise stated or the context otherwise requires, the terms “AccuStem” “we,” “us,” “our” and the “Company” refer collectively to AccuStem and, where appropriate, its subsidiaries.

 

ii

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   (Unaudited)     
   June 30, 2022   December 31, 2021 
         
ASSETS          
Current Assets          
Cash  $1,981,510   $- 
Related party receivable   -    1,353,373 
Prepaid expenses   390,954    - 
Total Current Assets  $2,372,464   $1,353,373 
Equipment, net   9,492    - 
           
TOTAL ASSETS  $2,381,956   $1,353,373 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current Liabilities          
Accounts payable  $108,961   $388,681 
Related party payable   87,599    190,838 
Accrued expenses   218,303    123,181 
Note Payable   316,527    - 
Total Current Liabilities   731,390    702,700 
           
TOTAL LIABILITIES   731,390    702,700 
           
Stockholders’ Equity          
Preferred stock $.001 par value; 10,000,000 shares authorized; none issued and outstanding  $-   $- 
Common stock $.001 par value; 150,000,000 shares authorized; 11,337,571 and 9,999,132 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively   11,337    9,999 
Additional paid-in capital   4,232,851    1,503,434 
Related party subscription receivable   -    (204,879)
Accumulated other comprehensive loss   -    66,981 
Accumulated deficit   (2,593,622)   (724,862)
TOTAL STOCKHOLDERS’ EQUITY   1,650,566    650,673 
           
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $2,381,956   $1,353,373 

 

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

 

1

 

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

   2022   2021   2022   2021 
   Three Months Ended June 30   Six Months Ended June 30 
   2022   2021   2022   2021 
                 
OPERATING EXPENSES                    
                     
Research and development expenses  $54,396   $30,198   $75,539   $32,815 
General and administrative expenses   1,023,830    20,339    1,793,221    31,595 
Total operating expenses   1,078,226    50,537    1,868,760    64,410 
LOSS FROM OPERATIONS   (1,078,226)   (50,537)   (1,868,760)   (64,410)
                     
LOSS, BEFORE TAX   (1,078,226)   (50,537)   (1,868,760)   (64,410)
Income tax benefit (expense)   -    -    -    - 
NET LOSS  $(1,078,226)  $(50,537)  $(1,868,760)  $(64,410)
                     
Net loss per share attributable to common stockholders, basic and diluted  $(0.10)  $(0.01)  $(0.17)  $(0.01)
                     
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted   11,337,107    9,999,132    10,682,986    9,999,132 
                     
NET LOSS  $(1,078,226)  $(50,537)  $(1,868,760)  $(64,410)
Translation adjustments   -    399    -    17,081 
                     
COMPREHENSIVE LOSS  $(1,078,226)  $(50,138)  $(1,868,760)  $(47,329)

 

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

 

2

 

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(UNAUDITED)

 

For Three Months Ended June 30, 2022

 

   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Loss   Accumulated Deficit   Stockholders’
Equity		 
   Common Stock   Additional   Related Party   Accumulated Other       
   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Loss   Accumulated Deficit   Stockholders’
Equity		 
Balance at March 31, 2022   11,337,102   $11,337   $4,195,076    -   -   $(1,515,396)  $2,691,017 

Share-based compensation

   -    -    37,588    -   -    -    37,588 
Exercise of common stock options   469    -    187    

-

  

-

    

-

    187 
Net loss   -    -    -         -   -    (1,078,226)   (1,078,226)
Balance at June 30, 2022   11,337,571   $11,337   $4,232,851    -   -   $(2,593,622)  $1,650,566 

 

For Three Months Ended June 30, 2021

 

   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Income   Accumulated Deficit   Stockholders’
Equity		 
   Common Stock   Additional   Related Party   Accumulated Other       
   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Income   Accumulated Deficit   Stockholders’
Equity		 
Balance at March 31, 2021   9,999,132   $9,999   $1,482,174   $(208,935)  $95,221   $(68,121)  $1,310,338 
Foreign currency translation adjustment   -    -    -    7    399    -    406 
Net loss   -    -    -    -    -    (50,537)   (50,537)
Balance at June 30, 2021   9,999,132   $9,999   $1,482,174   $(208,928)  $95,620    (118,658)  $1,260,207 

 

3

 

 

For Six Months Ended June 30, 2022

 

   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Income   Accumulated Deficit   Stockholders’
Equity		 
    Common Stock     Additional     Related Party     Accumulated Other              
    Number of Shares     Amount     Paid-in Capital     Subscription Receivable     Comprehensive Income     Accumulated Deficit    

Stockholders’

Equity

  
Balance at December 31, 2021     9,999,132     $ 9,999     $ 1,503,434     $ (204,879 )   $ 66,981     $ (724,862 )   $ 650,673  
Share-based compensation     -       -       54,628       -       -       -       54,628  
Issuance of common stock     1,337,970       1,338       2,674,602       -       -       -       2,675,940  
Receipt of subscription receivable     -       -       -       204,879       -       -       204,879  
Exercise of common stock options     469       -       187       -       -       -       187  
Foreign currency translation adjustment     -       -       -       -       (66,981 )     -       (66,981 )
Net loss     -       -       -       -       -       (1,868,760 )     (1,868,760 )
Balance at June 30, 2022     11,337,571     $ 11,337     $ 4,232,851       -       -     $ (2,593,622 )   $ 1,650,566  

 

For Six Months Ended June 30, 2021

 

   Number of Shares   Amount   Paid-in Capital   Subscription Receivable   Comprehensive Income   Accumulated Deficit   Stockholders’
Equity		 
    Common Stock     Additional     Related Party     Accumulated Other              
    Number of Shares     Amount     Paid-in Capital     Subscription Receivable     Comprehensive Income     Accumulated Deficit    

Stockholders’

Equity

  
Balance at December 31, 2020     9,999,132     $ 9,999     $ 1,482,174     $ (206,663 )   $ 78,534     $ (54,248 )   $ 1,309,796  
Foreign currency translation adjustment     -       -       -       (2,265 )     17,086       -       14,821  
Net loss     -       -       -       -       -       (64,410 )     (64,410 )
Balance at June 30, 2021     9,999,132     $ 9,999     $ 1,482,174     $ (208,928 )   $ 95,620     $ (118,658 )   $ 1,260,207  

 

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

 

4

 

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   2022   2021 
  For the Six Months Ended June 30 
   2022   2021 
Operating Activities          
Net loss   (1,868,760)   (64,410)
           
Adjustments to reconcile net income to net cash provided by operating activities       
Foreign currency translation   (66,981)   14,815 
Depreciation   1,507    - 
Share-based compensation   54,628    - 
Change in operating assets and liabilities:          
Related party receivable   1,353,373   (14,959)
Prepaid expenses    48,168    -
Accounts payable    (279,720)   51,015 
Related party payable    (103,239)   13,075 
Accrued expenses   96,278    464 
Net cash used in operating activities   (764,746)   - 
           
Investing Activities          
Purchases of equipment   (10,999)   - 
Net cash used in investing activities   (10,999)   - 
           
Financing Activities          
Proceeds from receipt of subscription receivable   204,879    - 
Issuance of common stock   2,676,127    - 
Payments on note payable   (123,751)   - 
Net cash provided by financing activities   2,757,255    - 
           
Increase in cash   1,981,510    - 
           
Cash, beginning of year   -    - 
Cash, end of year   1,981,510    - 
           
Supplemental disclosure of noncash investing and financing activities          
Issuance of Note Payable for payment of prepaid expense   439,122    - 
           
Supplemental cash flow information          
Cash paid for interest   1,503    - 

 

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

 

5

 

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

1. NATURE OF BUSINESS

 

AccuStem Sciences, Inc. is an early-stage life sciences company committed to developing and commercializing novel products for the treatment and management of many cancers. The principal activities of the Company are that of a genomics-based personalized medicine business, particularly focused on breast and lung cancer patients.

 

Impact of the COVID-19 Pandemic

 

In early 2020, an outbreak of the novel strain of coronavirus (COVID-19) emerged globally. As a result, there have been mandates from federal, state and local authorities resulting in an overall decline in economic activity. There have been no material impacts from COVID-19 on the Company’s operations for the six months ended June 30, 2022 and 2021. However, it is possible that the pandemic will continue to significantly impact economies worldwide, which could result in adverse effects on the Company’s operations. The extent of the impact of COVID-19 on operations, liquidity, financial condition, and results of operations remain uncertain at this time.

 

Liquidity and Going Concern

 

The condensed consolidated financial statements have been prepared on the going concern basis, which contemplates the realization of assets and discharge of liabilities in the normal course of business.

 

The Company has financed its activities principally from support from a related party. The Company has incurred a net loss in every fiscal period since inception. For the six months ended June 30, 2022, the Company incurred a net loss of $1,868,760. The Company has an accumulated deficit of $2,593,622 as of June 30, 2022. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, further development of its technology and products, and expenses related to the commercialization of its products.

 

Management believes that the Company does not have sufficient cash and current assets to support its operations through at least 12 months from the issuance date of these condensed consolidated financial statements, and will require significant additional cash resources to continue its planned research and development activities.

 

The Company will need additional funds for promoting new products and working capital required to support research and development activities and generate sales from its products. There can be no assurance, however, that such financing will be available when needed, if at all, or on favorable terms and conditions. The precise amount and timing of the funding needs cannot be determined accurately at this time, and will depend on a number of factors, including the quality of product development efforts, management of working capital, and the continuation of normal payment terms and conditions for purchase of services.

 

6

 

 

In order to address its capital needs, including its planned research and development activities and other expenditures, the Company is actively pursuing additional equity financing in the form of a private investment and public equity. The Company has been in ongoing discussions with institutional investors and other parties with respect to such possible offerings. Adequate financing opportunities might not be available to the Company, when and if needed, on acceptable terms or at all. If the Company is unable to obtain additional financing in sufficient amounts or on acceptable terms or if the Company fails to consummate the private placement or a public offering, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs and product portfolio expansion, which could adversely affect its operating results or business prospects. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding in terms acceptable to the Company to fund continuing operations, if at all. After considering the uncertainties, management determined it is appropriate to continue to adopt the going concern basis in preparing the condensed consolidated financial statements.

 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The principal accounting policies applied in the preparation of these condensed consolidated financial statements are set out below.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on April 18, 2021. Unless otherwise indicated, all references to “$” are to U.S. dollars, and all references to “£” or “GBP” are to Great Britain Pounds. The Company’s reporting currency is U.S. dollars.

 

Basis of Consolidation

 

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary after elimination of intercompany transactions and balances.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management of the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates.

 

Comprehensive Loss

 

Comprehensive loss of all periods presented is comprised primarily of net loss and foreign currency translation adjustments.

 

Risk and Uncertainties

 

The Company is subject to a number of risks similar to those of other companies of similar size in its industry, including but not limited to, the success of its exploration to research and development activities, need for additional capital (or financing) to fund operating losses, competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation, dependence on key individuals, and risks associated with changes in information technology.

 

Cash

 

The Company considers all highly liquid investments purchased with an original maturity date of three months or less at the date of purchase and money market accounts to be cash equivalents. At June 30, 2022 and December 31, 2021, the Company had no cash equivalents and all cash amounts consisted of cash on deposit.

 

7

 

 

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant contribution of credit risk consist of cash. Periodically, the Company maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high credit quality and the Company has not experienced any losses in these deposits.

 

Equipment, net

 

Equipment is stated at cost, less accumulated depreciation. The Company depreciates its equipment for financial reporting purposes using the straight-line method over the estimated useful lives of the assets. The Equipment consists of computer equipment, which has a useful life of 3 years. Maintenance and repairs are expensed when incurred. Additions and improvements that extend the economic useful life of the asset are capitalized and depreciated over the remaining useful lives of the assets. The cost and accumulated depreciation of assets sold or retired are removed from the respective accounts, and any resulting gain or loss is reflected in current earnings.

 

Share-based Compensation

 

The Company may award stock options, performance-based options and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized over the requisite service period on a straight-line basis over the vesting period except for performance-based options. Performance-based stock options vest based on the achievement of performance targets. Compensation costs associated with performance-based option awards are recognized over the requisite service period based on probability of achievement. Performance-based stock options require management to make assumptions regarding the likelihood of achieving performance targets.

 

The Company estimates the fair value of service based and performance-based stock option awards, including modifications of stock option awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.

 

Recent Accounting Standards

 

Adopted Accounting Standards

 

None

 

Standards not yet adopted

 

None

 

8

 

 

3. ACQUISITION OF STEMPRINTER SCIENCES LIMITED AND EQUITY RAISE

 

The consolidated position of the Company is a result of the demerger of StemPrintER Sciences Limited (“StemPrintER”) from Tiziana Life Sciences plc (“Tiziana”) on October 30, 2020.

 

On October 5, 2020, AccuStem Sciences Limited (“Limited”) entered into an agreement with Tiziana to acquire its subsidiary StemPrintER, including the ownership rights and intellectual property relating to the StemPrintER project, the SPARE project and cash receivable of $1,353,373 (which was collected in January 2022). In exchange for the transfer of ownership, Limited issued a total of 9,520,069 ordinary shares of $0.001 par value to Tiziana shareholders on a one for one basis based on the Tiziana ownership at October 30, 2020. On October 30, 2021, a supplemental demerger agreement was executed and 479,063 of ordinary shares of $0.001 par value issued for consideration of $204,879 in relation to the associated option and warrant holders of Tiziana. The Company considered ASC 805 - Business Combinations and ASC 730 - Research and Development in determining how to account for the transaction. As the transaction was between entities that were ultimately controlled by the same parties, the acquisition has been treated as a common control combination under ASC 805-50 - Business Combinations, therefore the carrying value of contributed assets remained unchanged and were recorded at historical costs.

 

The transfer of all the ownership rights and intellectual property was treated as an asset transfer. The treatment as a separate asset acquisition at this stage reflected the fact that, immediately prior to transfer, Tiziana carried out only limited maintenance type activity on the StemPrintER project and the concentration of fair value was in the StemPrintER intellectual property asset.

 

In March 2022, per the terms of the supplemental agreement to the demerger agreement, Tiziana invested $2,765,940 (£2,000,000 GBP) in exchange for an additional 1,337,970 common shares of the Company. No offering costs were recorded with the additional contribution.

 

4. NOTE PAYABLE

 

On May 20, 2022, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $439,122. Under the terms of the agreement, the Company made a down payment of $88,000, with the remaining balance financed over the remaining term at an annual percentage rate of 3.95%. Beginning June 2022, the Company will make 10 monthly payments of $35,751, with the last payment expected to be made in March 2023. At the end of June 30, 2022, the outstanding balance on the note payable was $321,760.

 

5. EQUIPMENT

 

Equipment consists of the following:

 

  

June 30, 2022

   December 31, 2022 
Computer equipment  $10,999            - 
Less: Accumulated depreciation   1,507    - 
Equipment, net  $9,492    

-

 

 

Depreciation expense was approximately $830 and $0, respectively, for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, respectively, depreciation expense was approximately $1,507 and $0, respectively.

 

Depreciation expense is included within General and Administrative expenses in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss.

 

6. LICENSE

 

On June 24, 2014, Tiziana entered into an exclusive license agreement with IEO/University of Milan, pursuant to which it obtained a worldwide, royalty-bearing, exclusive license under certain patents and a worldwide, royalty-bearing, non-exclusive license under certain know-how, respectively, of IEO/University of Milan to develop and commercialize licensed products in connection with a multi-gene prognostic tool. This license was assigned to the Company pursuant to the terms of the acquisition of StemprintER as noted in Note 3.

 

9

 

 

The license provides for full control and authority over the research, development and commercialization of licensed products and are required to use commercially reasonable efforts in connection with the development and commercialization of the licensed products.

 

For the term of the license, the following milestone payments are required to be made (converted from EUROS to USD using exchange rate of €1:$1.10815)

 

  ● €50,000 ($55,408) within 30 days of completion of development of a commercial test;
  ● €100,000 ($110,815) within 30 days of the first commercial sale of a licensed product; and
  ● €150,000 ($166,223) within 30 days of first regulatory approval in the U.S. or any other major market.

 

Tiziana was also required, as licensee prior to the assignment to us of the License, to fund €50,000 ($55,408) per year for sponsored research for up to four years from the effective date of the license (2014-2018), subject to certain conditions. The license also requires payment for all ongoing patent prosecution and maintenance costs and for the royalty term (until the expiration of the last claim in an issued, unexpired patent within the licensed patents or a claim that has not been pending more than four years which covers the sale of such licensed product or service in such country) a royalty of 1.5% on net sales of licensed products and services (and a 15% royalty of sub-license revenues for each country for the term of the license). The license agreement may be terminated at any time on 30 days’ notice and either party may terminate the license by written notice for a material payment breach or any other material breach, subject to 45-day and 120-day periods, respectively. Absent early termination, the license will remain in effect, on a product by product and country by country basis, until the date on which the patents and patent applications expire. The license may also be terminated in the case of insolvency.

 

For the three and six months ended June 30, 2022 and 2021, the Company did not recognize any expense related to this license agreement.

 

7. LOSS PER SHARE

 

Basic and diluted net loss per common share were the same since the inclusion of common shares issuable pursuant to the exercise of options in the calculation of diluted net loss per common shares would have been antidilutive.

 

For the three and six months ended June 30, 2022 and 2021, loss per share of the Company are as follows:

 

   2022   2021   2022   2021 
   Three Months Ended June 30   Six Months Ended June 30 
   2022   2021   2022   2021 
Numerator:                    
Net Loss  $(1,078,226)  $(50,537)  $(1,868,760)  $(64,410)
Net loss per share attributable to common stockholders  $(1,078,226)  $(50,537)  $(1,868,760)  $(64,410)
Denominator:                    
Weighted average common shares outstanding, basic and diluted   11,337,107    9,999,132    10,682,986    9,999,132 
Net loss per share attributable to common stockholders, basic and diluted  $(0.10)  $(0.01)  $(0.17)  $(0.01)

 

The Company’s potentially dilutive securities, which include stock options and warrants, have been excluded from the computation of diluted net loss per common share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common shareholders is the same.

 

10

 

 

The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders for the three months and six months ended June 30, 2022 and 2021 because including them would have had an anti-dilutive effect.

 

   Three Months Ended June 30   Six Months Ended June 30 
   2022   2021   2022   2021 
Stock options to purchase common stock outstanding   173,517    -    173,517    - 
Total   173,517    -    173,517    - 

 

8. SHARE-BASED COMPENSATION

 

In August 2021, Limited adopted the 2021 Omnibus Equity Incentive Plan (the “Incentive Plan”). The Incentive Plan provides that the Company may grant Options, Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, and Other Share-Based Awards to selected employees, directors, and independent contractors of the Company.

 

Each Award shall be exercisable at such time or times and subject to such terms and conditions set forth in the Incentive Plan, as shall be determined by the administrator in the applicable award agreement. Total shares authorized by the plan was 2,500,000. Awards under the Incentive Plan are exercisable for up to 10 years from the date of issuance. There are 1,092,756 remaining available shares to be issued under the Incentive Plan at June 30, 2022. The number of shares of Common Stock that are reserved and available for issuance under the Incentive Plan shall be subject to an annual increase on the first day of each calendar year beginning with the first January 1 following the effective date and ending with the last January 1 during the initial ten-year term of the Plan as defined in Section 4(a) of the Incentive Plan.

 

Options

 

On December 1, 2021 (the “Effective Date”), Limited completed the Company’s redomiciliation from the United Kingdom to Delaware (see Note 1). As of the Effective Date, the option instruments to purchase Limited Ordinary Shares granted by Limited (the “Old Options”) were exchanged automatically in consideration of the grant of new options by New AccuStem which, in the opinion of the board of directors of Limited, are equivalent to the Old Options, but relate to the New AccuStem Common Stock. As of the Effective Date, New AccuStem assumed Limited’s obligations under its 2021 Incentive Plan and other arrangements under which incentives in relation to Limited Ordinary Shares were agreed with before the effective date of the redomiciliation and the Company replaced all equity awards granted under the Limited Plan with equivalent equity awards for New AccuStem Common Stock. Also, as of the Effective Date, New AccuStem’s 2021 Equity Incentive Plan (the “2021 Plan”), became effective. Any employee, director or consultant of New AccuStem or any of its subsidiary is eligible to participate in the 2021 Plan.

 

As a result of the redomiciliation an aggregate of 100,005 options were issued during December 2021 in consideration for the share exchange. The issued options had an exercise price of $0.42 per share and all expire on the ten-year anniversary of the grant date. These options were fully vested on the grant date.

 

In addition, the Company issued 1,307,239 options during the first quarter of 2022 for employees, directors and non-employees under the Incentive Plan.

 

The options granted have an exercise price ranging from $1.06 to $2.13 and expire on the ten-year anniversary of the grant date.

 

There were no options granted or modified for the three months ended June 30, 2022 and for the three and six months ended June 30, 2021.

 

11

 

 

For the six months ended June 30, 2022, stock option activity for time-based options of the Company are as follows:

 

  

Number of

Time-Based

Share Options

  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual

Life (in years)

  

Aggregate

Intrinsic

Value

 
Outstanding at January 1, 2022   100,005   $0.42    9.72   $— 

Issued

   363,239    2.07    9.68      
Exercised   (469)   0.28    —      
Expired/Forfeited   —    —    —      
Outstanding at June 30, 2022   462,775   $1.69    9.55   $21,897 
                     
Vested and exercisable June 30, 2022   173,048   $0.95    9.32   $21,897 

 

For the six months ended June 30, 2022, stock option activity for performance-based options of the Company are as follows:

 

  

Number of

Performance-

Based

Share Options

  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual

Life (in years)

  

Aggregate

Intrinsic

Value

 
Outstanding at January 1, 2022   —   $—    —   $— 
Issued   944,000    1.45    9.86      
Exercised   —    —    —      
Expired/Forfeited   —    —    —      
Outstanding at June 30, 2022   944,000   $1.45    9.61   $— 
                     
Vested and exercisable June 30, 2022   —    —    —    — 

 

The aggregate intrinsic value is calculated as the difference between the estimated fair value of the underlying common stock as of June 30, 2022 and the option exercise price.

 

Total share-based compensation was approximately $37,588 and $0, respectively, for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, respectively, share-based compensation was approximately $54,629 and $0, respectively.

 

Total share-based compensation expense is included in General and Administrative expenses on the Condensed Consolidated Statement of Operations and Other Comprehensive Income.

 

The weighted average grant date fair value for stock options granted during the three months ended March 31, 2022 is $0.76. The performance-based and time-based stock options are equity-classified. There were no stock option granted during the three months ended June 30, 2022.

 

The Company uses the Black-Scholes option pricing model to estimate the fair value of the option awards. The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for the six months ended June 30, 2022.

 

   

For the Six

Months Ended

 
   June 30, 2022 
Risk-free interest rate  1.54 - 2.34%
Expected dividend yield  —%
Expected term  5.00 – 8.50 years 
Expected volatility  57.2 - 65.7%

 

12

 

 

The risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero- coupon issues with a remaining term commensurate with the expected term of the award. The Company has historically been a private company and lacks company-specific historical and implied volatility information. Management has estimated expected volatility based on similar public companies. Expected life of the option represents the period of time options are expected to be outstanding. The estimate for dividend yield is 0% because the Company has not historically paid, and does not intend to pay, a dividend on common stock in the foreseeable future.

 

As of June 30, 2022, there was $942,781 unrecognized compensation expense related to options. $249,443 of this cost is subject to time-based conditions, and is to be recognized over a period of approximately 3.6 years. The remaining $693,338 of unrecognized compensation expense relates to performance-based conditions for unvested options. These costs are expected to be recognized over the required service period once the performance condition has occurred or becomes probable. Compensation costs related to the performance stock options are evaluated at each reporting period and subsequently adjusted for changes in the expected outcomes of the performance conditions.

 

Warrants

 

In March 2022, the Company issued 350,000 common stock warrants to a non-employee under the Incentive Plan. The common stock warrants are subject to vesting and, grantees become fully vested and exercisable when certain performance requirements are met.

 

The common stock warrants granted have an exercise price of $1.06. The common stock warrants expire on the ten-year anniversary of the grant date. There were no warrants issued during the three months ended June 30, 2022 and 2021.

 

A summary of the Company’s warrants to purchase common stock activity is as follows:

 

  

Number of

shares

  

Weighted

Average

Exercise Price

  

Weighted

average

remaining

contractual

life (in years)

  

Aggregate

Intrinsic

Value

 
Outstanding at January 1, 2022   —   $—    —   $— 
Issued   350,000    1.06    9.82      
Exercised   —    —    —      
Expired/Forfeited   —    —    —      
Outstanding at June 30, 2022   350,000   $1.06    9.82   $136,500 
                     
Vested and exercisable June 30, 2022   —    —    —    — 

 

The grant date fair value for these warrants of $0.66 per warrant for a total fair value of $232,490. The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of the common stock warrants options awarded for the six months ended June 30, 2022.

  

Six Months Ended

June 30, 2022

 
Risk-free interest rate   1.75%
Expected dividend yield   —%
Expected term   8.50 years 
Expected volatility   63.9%

 

13

 

 

There was no share-based compensation expense recognized during the three and six months ended June 30, 2022 and 2021 for warrants.

 

As of June 30, 2022, there was $232,490 of total performance-based unrecognized compensation costs related to unvested common stock warrants. These costs are expected to be recognized once the performance condition has occurred or becomes probable.

 

9. RELATED PARTY TRANSACTIONS

 

Tiziana is a related party as it is under common control. The Company and Tiziana share directors, officers and significant shareholders. The Company has also been formed due to an acquisition of a subsidiary company from Tiziana. As of June 30, 2022, Tiziana owns approximately 11.8% of the Company.

 

As of June 30, 2022 and December 31, 2021, $0 and $1,558,252 respectively, was due from Tiziana in relation to the demerger and supplemental demerger of Limited and StemPrintER, which consists of the related party receivable and related party subscription receivable on the condensed consolidated balance sheet.

 

Effective with the demerger agreement, the Company entered into a shared services agreement, where the Company outsources certain limited management and administrative services. The Company notes that the fees consist of payroll costs associated with time spent providing services for the Company and are based on actual time spent and the allocated payroll costs. In addition, the Company is charged at cost, for utilization of certain office space. There was no mark-up associated with fees charged for these services. For the three months ended June 30, 2022 and 2021, the Company has incurred approximately $22,087 and $3,154, respectively. Total cost for the six months ended June 30, 2022 and 2021 were $26,447 and $6,179, respectively.

 

As of June 30, 2022 and December 31, 2021, $54,599 and $190,838 respectively, was also due to Tiziana, as Tiziana had paid for expenses on behalf of the Company.

 

In January 2022, the Company and Gabriele Cerrone, who is the Chairman of the Board of Directors and the largest shareholder, entered into an agreement in which he will provide consulting services to the Company for a monthly fee of $5,500. As of June 30, 2022, $33,000 was due to Gabriele Cerrone.

 

10. INCOME TAXES

 

For all periods presented, the pretax losses incurred by the Company received no corresponding tax benefit because the Company concluded that it is more likely than not that the Company will be unable to realize the value of any resulting deferred tax assets. The Company will continue to assess its position in future periods to determine if it is appropriate to reduce a portion of its valuation allowance in the future. On March 27, 2020, Congress enacted the CARES Act to provide certain relief as a result of the COVID-19 pandemic. The CARES Act, among other things, includes provisions relating to net operating loss carryback periods, alternative minimum tax credit refunds, and modification to the net interest deduction limitations. The CARES Act did not have a material impact on the Company’s consolidated financial statements for the six months ended June 30, 2022. The Company continues to monitor any effects on its financial statements that may result from the CARES Act.

 

The Company has no open tax audits with any taxing authority as of June 30, 2022.

 

11. COMMITMENTS AND CONTINGENCIES

 

Legal Proceedings

 

The Company is involved from time to time in various claims, proceedings, and litigation. The Company establishes reserves for specific legal proceedings when it determines that the likelihood of an unfavorable outcome is probable, and the amount of loss can be reasonably estimated. Management has not identified any legal matters where it believes an unfavorable outcome is reasonably possible and/or for which an estimate of possible losses can be made.

 

14

 

 

Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the related notes included elsewhere in this Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on April 18, 2022. In addition to our historical condensed consolidated financial information, the following contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q.

 

Overview

 

We are a clinical stage diagnostic company dedicated to improving quality of life and outcomes for the more than 18 million patients worldwide who are diagnosed with cancer each year. Our plan is to develop and commercialize an array of products in the diagnostics, pharmaceutical and medical device spaces that enable more informed treatment planning and more effective treatment options for patients. Our initial focus is the commercialization of a proprietary genomic platform, Stem Print, for recurrence risk stratification of different types of cancer. The platform was developed to measure the “stemness” of tumors, or how likely a cancer is to recur or be resistant to standard treatments, which could impact how patients are managed by their multi-disciplinary care team. To augment this proprietary offering we also plan to provide ancillary commodity testing (e.g., hereditary genetic testing, somatic mutation testing) to provide additional information and value to patients and physicians through the patient care continuum.

 

Our initial focus will be providing genomic and genetic testing to patients diagnosed with breast and lung cancer. Our primary product candidate is StemPrintER and related assets, a 20-gene prognostic assay intended to predict the risk of distant recurrence (“DR”) in luminal (ER+/HER2-negative) breast cancer patients. StemPrintER has been validated in several clinical cohorts and studies , the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology (IEO) and approximately 800 patients from the TransATAC study. In the IEO cohort, StemPrinter High Risk patients (SPRS High) were 1.85 times more likely to have a distant recurrence compared to Low Risk (SPRS Low) patients (Figure 1) and in the TransATAC cohort, SPRS High patients were 4.27 times more likely to experience a distant recurrence compared to SPRS Low Risk patients (Figure 2). Together, these data confirm that StemPrintER is highly prognostic for outcomes in patients with breast cancer and indicate the potential utility of the test in the oncology clinic.

 

 

 

*SPRS- StemPrintER Recurrence Score; SPRS High- StemPrintER High Risk; SPRS Low- StemPrintER Low Risk

 

Given the broad applicability of tumor “stemness”, which has been evaluated in a multitude of different cancers, we believe the StemPrint platform will have meaningful clinical utility beyond breast cancer. As such, we will seek to validate and commercialize StemPrint for a variety of different tumor types. Each tumor type, where applicable, would also include ancillary testing to boost our value proposition to physicians and their patients.

 

In addition to StemPrintER, our second product candidate is the MicroRNA Signature Classifier (MSC) test which is designed to evaluate 24 microRNA’s (miRNA) to help determine whether lung nodules identified by low dose computed tomography (LDCT) screening are benign or malignant. With the increasing utilization of LDCT programs to identify lung cancers earlier, millions of lung nodules are being identified each year [support]. In most cases, clinical factors alone are insufficient to determine which nodules require further intervention (e.g., biopsy) versus surveillance. We believe the MSC test could help triage patients to the most appropriate care path saving healthcare system dollars and providing patients with more confidence in their treatment plan. The blood-based MSC test was validated in a subset of 939 patients from the prospective, randomized MILD study and demonstrated 87% sensitivity, 81% specificity and a 99% negative predictive value for detecting lung cancer. This validation study indicated that MSC has predictive, diagnostic, and prognostic value and could reduce the false-positive rate of LDCT, thus improving the efficacy of lung cancer screening.

 

We plan to launch StemPrintER and MSC testing once we have achieved several key milestones. First, we are planning to build our corporate headquarters in Phoenix, AZ that will also house a clinical laboratory. That laboratory will be responsible for processing, testing and reporting StemPrintER and MSC results for all commercial samples. Further, we plan to transfer the StemPrintER and MSC technologies from the laboratories in which they were developed to our laboratory in Phoenix. Finally, once our laboratory is established, we will seek to obtain U.S. Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certification so that we are able to report results for clinical use and to seek reimbursement from the Centers for Medicare and Medicaid Services. We anticipate that it will take at least 18 months to complete these milestones. Once those tasks are complete, we plan to initially launch StemPrintER in the US and then expand to other markets as we evaluate clinical need and revenue opportunity.

 

 

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Impact of the COVID-19 Pandemic

 

In early 2020, an outbreak of the novel strain of coronavirus (COVID-19) emerged globally. As a result, there have been mandates from federal, state and local authorities resulting in an overall decline in economic activity. There have been no material impacts from COVID-19 on the Company’s operations for the periods through June 30, 2022. However, it is possible that the pandemic will continue to significantly impact economies worldwide, which could result in adverse effects on the Company’s operations. The extent of the impact of COVID-19 on operations, liquidity, financial condition, and results of operations remain uncertain at this time.

 

Financial Operations Overview

 

We have no products approved for commercial sale and have not generated revenue to date. We have never been profitable and have incurred net losses in each year since inception. We incurred net losses of $1,078,226 and $50,537 for the three months ended June 30, 2022 and 2021, respectively. We incurred net losses of $1,868,760 and $64,410 for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we had an accumulated deficit of $2,593,622. Substantially all of our net losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

 

Segment Information

 

As of June 30, 2022, we viewed our operations and managed our business as one operating segment consistent with how our chief operating decision maker, our Chief Executive Officer, makes decisions regarding resource allocation and assessing performance. As of June 30, 2022, substantially all of our assets were located in the United States. Our headquarters and operations are located in New York, NY and London, UK.

 

Results of Operations

 

The following discussion and analysis of our results of operations includes a comparison of the three and six months ended June 30, 2022 to the three and six months ended June 30, 2021:

 

    Three Months Ended June 30                

Six Months Ended June 30

 

 

 

        
    2022     2021     $ Change     % Change     2022     2021     $ Change     % Change  
Research and development expenses   $ 54,396     $ 30,198     $ 24,198                      80 %   $ 75,539     $ 32,815     $ 42,724                      130 %
General and administrative expenses     1,023,830       20,339       1,003,491       4934 %     1,793,221       31,595       1,761,626       5576 %
Loss from operations     1,078,226       50,537       1,027,689       2034 %     1,868,760       64,410       1,804,350       2801 %
Loss, before income tax     (1,078,226 )     (50,537 )     (1,027,689 )     2034 %     (1,868,760 )     (64,410 )     (1,804,350 )     2801 %
Income tax benefit (expense)     -       -       -       0 %     -       -       -       0 %
Net Loss   $ (1,078,226 )   $ (50,537 )   $ (1,027,689 )     2034 %   $ (1,868,760 )   $ (64,410 )   $ (1,804,350 )     2801 %

 

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Research and development

 

Research and development expenses for the three and six months ended June 30, 2022 increased compared to the three and six months ended June 30, 2021 primarily due to increase in patent related expenses.

 

General and administrative

 

General and administrative expenses for the three and six months ended June 30, 2022 increased compared to the three and six months ended June 30, 2021 primarily due to increase an increase of payroll related costs as a result of the new management team structure, as well as costs related to legal fees and other compliance expenses.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

Since our inception, we have not generated any revenue and have incurred significant operating losses. Our potential products are at various phases of development. We do not expect to generate significant revenue from product sales for several years, if at all. Pursuant to the demerger, Tiziana transferred $1,353,373 (£1,000,000) in cash in January 2022 to the Company. In addition, subject to the terms of the supplemental demerger agreement, Tiziana invested $2,675,940 (£2,000,000) in cash in March 2022 for additional shares of the Company. Our cash flows may fluctuate and are difficult to forecast and will depend on many factors. As of June 30, 2022, our cash balance is $1,981,510, which is adequate for our current planned level of operations, through at least December 2022.

 

Cash Flows

 

The following table summarizes our cash flows:

 

   Six Months Ended June 30, 
   2022   2021 
Cash flows used in operating activities  $(764,746)  $— 
           
Cash flows used in investing activities   (10,999)   — 
           
Cash flows from financing activities   2,757,255    — 
           
Net increase in cash and cash equivalents   1,981,510    — 
Cash and cash equivalents at beginning of period   —    — 
Cash and cash equivalents at end of period  $1,981,510   $— 

 

The Company did not generate any cash flows through June 30, 2021 as cash was funded by a related party.

 

Operating Activities

 

There was an increase in cash flows from operating activities during the six months ended June 30, 2022 due to the collection of a receivable from a related party. There were no cash flows from operating activities during the six months ended June 30, 2021.

 

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Investing Activities

 

The cash flow used in investing activities increased during the six months ended June 30, 2022 due to the purchase of computer equipment. There were no cash flows from investing activities during the six months ended June 30, 2021.

 

Financing Activities

 

We generated cash flows from financing activities during the six months ended June 30, 2022 due to proceeds from the issuance of common stock to Tiziana, as mentioned in the “Sources of Liquidity” section above. There was no net cash received in financing investing activities for the six months ended June 30, 2021.

 

Market Capital Expenditure Commitments

 

We have no material commitment for capital expenditures.

 

Funding Requirements

 

We expect that our expenses will increase and operating losses will be generated, and we have $2,593,622 of accumulated deficit as at June 30, 2022. Based on our current plans, we believe our existing cash and cash equivalents will be sufficient to fund our operations and capital expenditure requirements until December 2022. We expect to incur substantial additional expenditures in the near term to support our acceleration of activities. We expect to incur net losses for the foreseeable future. Our ability to fund our product development and clinical operations as well as commercialization of our product candidates, will depend on the amount and timing of cash received from planned financings. Our future capital requirements will depend on many factors, including:

 

  ● the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates;
     
  ● the costs of commercialization activities, including product marketing, sales and distribution;
     
  ● the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
     
  ● the emergence of competing technologies and products and other adverse marketing developments;
     
  ● the effect on our product development activities of actions taken by the FDA, EMA or other regulatory authorities;
     
  ● our degree of success in commercializing our product candidates, if and when approved; and
     
  ● the number and types of future products we develop and commercialize.

 

A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

 

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity financings, debt financings, collaborations with other companies or other strategic transactions. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

 

18

 

 

Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.

 

Critical Accounting Policies

 

There have been no significant changes to our critical accounting policies and estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our Form 10-K for the year ended December 31, 2021.

 

Off-Balance Sheet Arrangements

 

We have no other off-balance sheet arrangements that have had, or are reasonably likely to have, a material current or future effect on our consolidated financial statements or changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Recent Accounting Pronouncements

 

For information on recent accounting pronouncements, see our condensed consolidated financial statements - Note 2 and the related notes found elsewhere in this quarterly report.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

There have been no significant changes to our quantitative and qualitative disclosures about market risk as discussed in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risk,” included our Form 10-K for the year ended December 31, 2021.

 

Item 4. Controls and Procedures

 

Management’s Annual Report on Internal Control over Financial Reporting

 

The Company’s management is responsible for establishing and maintaining adequate internal controls over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The Company’s internal control over financial reporting are a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles (“US GAAP”).

 

Because of their inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

19

 

 

Under the supervision and with the participation of management, the Company’s Chief Executive Officer and the Company’s Chief Financial Officer, the Company conducted an evaluation of the effectiveness of its internal control over financial over financial reporting based on the framework described in Internal Control-Integrated Framework issued by the Commission of Sponsoring Organizations of the Treadway Commission, as revised in 2013. Based on that evaluation, management has concluded that the Company did not maintain effective internal control over financial reporting as of the period ended June 30, 2022 due to the existence of the material weaknesses in internal control over financial reporting described below.

 

Material Weaknesses

 

A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

 

Management has determined that the Company did not maintain effective internal control over financial reporting as of the period ended June 30, 2022 due to the existence of the following material weaknesses identified by management:

 

Lack of Accounting Resources

 

The Company had a lack of accounting resources resulting in inadequate monitoring controls and other oversight procedures. Our management has determined that our disclosure controls and procedures and internal controls were ineffective due to weaknesses in our financial closing process, inadequate segregation of duties over authorization, review and recording of transactions, lack of accounting resources, as well as the financial reporting of such transactions.

 

Remediation efforts to address the material weakness relating to the Control Environment

 

Management intends to remediate this item in the following manner:

 

i. Recruit appropriately skilled accounting resources

 

Accordingly, management has determined that these control deficiencies constitute a material weakness. Management has begun implementing the Remediation Plan described herein and intends to continue working on it through the year ended December 31, 2022.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during the quarter ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

20

 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

There have been no material changes to the risk factors previously disclosed in our Form 10-K for the year ended December 31, 2021

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not Applicable.

 

Item 5. Other Information

 

None.

 

21

 

 

Item 6. Exhibits

 

10.1* Form of Common Stock Purchase Agreement (incorporated by reference to Exhibit 10.1 to Form 8-K filed with the SEC on April 5, 2022).

 

31.1 Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act

 

31.2 Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act

 

32.1 Certification by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

32.2 Certification by Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

101.INS* Inline XBRL Instance Document

 

101.SCH* Inline XBRL Taxonomy Extension Schema Document

 

101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document

 

101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document

 

101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

22

 

 

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 on August 12, 2022.

 

  ACCUSTEM SCIENCES, INC.
   
  /s/ Keeren Shah
  Keeren Shah
  Chief Financial Officer

 

In accordance with the Securities Exchange Act of 1934, this Report has been signed below on August 12, 2022 by the following persons on behalf of the Registrant and in the capacities indicated.

 

/s/ Wendy Blosser  
Wendy Blosser  
Chief Executive Officer and Director  
   
/s/ Keeren Shah  
Keeren Shah  
Chief Financial Officer  

 

23

 

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