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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 ended June 30, 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: 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 14, 2023, there were 11,346,535 shares of Common Stock, $0.001 par value outstanding.

 

 

 

 

 

 

Table of Contents

 

    Page
     
PART I- FINANCIAL INFORMATION 1
     
Item 1. Financial Statements 1
     
  Condensed Consolidated Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022 1
     
  Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2023 and 2022 2
     
  Unaudited Condensed Statements of Changes in Stockholders’ Deficit for the Three and Six Months Ended June 30, 2023 and 2022 3
     
  Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022 5
     
  Notes to Unaudited Condensed Consolidated Financial Statements 6
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 14
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 19
     
Item 4. Controls and Procedures 19
     
PART II - OTHER INFORMATION 20
     
Item 1. Legal Proceedings 20
     
Item 1A. Risk Factors 20
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 20
     
Item 3. Defaults Upon Senior Securities 20
     
Item 4. Mine Safety Disclosures 20
     
Item 5. Other Information 20
     
Item 6. Exhibits 21
     
SIGNATURES 22

 

i

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

ACCUSTEM SCIENCES INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  

June 30,

2023

  

December 31,

2022

 
         
ASSETS          
Current Assets          
Cash  $120,651   $733,978 
Prepaid expenses   332,016    168,430 
Other Current Assets   -    29,603 
Total Current Assets  452,667   932,011 
Equipment, net   5,863    7,678 
           
TOTAL ASSETS  $458,530   $939,689 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current Liabilities          
Accounts payable  $382,769   $311,834 
Related party payable   713,154    142,229 
Accrued expenses   371,539    518,625 
Note Payable   297,880    106,551 
Total Current Liabilities   1,765,342    1,079,239 
           
TOTAL LIABILITIES   1,765,342    1,079,239 
           
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; 11,346,535 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively   11,346    11,346 
Additional paid-in capital   4,359,220    4,320,385 
Accumulated deficit   (5,677,378)   (4,471,281)
TOTAL STOCKHOLDERS’ EQUITY   (1,306,812)   (139,550)
           
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $458,530   $939,689 

 

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

(Unaudited)

 

   2023   2022   2023   2022 
  

Three Months Ended

June 30

  

Six Months Ended

June 30

 
   2023   2022   2023   2022 
                 
OPERATING EXPENSES                    
                     
Research and development expenses  $14,575   $54,396   $30,177   $75,539 
General and administrative expenses   358,181    1,023,830    1,175,920    1,793,221 
Total operating expenses   372,756    1,078,226    1,206,097    1,868,760 
LOSS FROM OPERATIONS   (372,756)   (1,078,226)   (1,206,097)   (1,868,760)
                     
LOSS, BEFORE TAX   (372,756)   (1,078,226)   (1,206,097)   (1,868,760)
Income tax benefit (expense)   -    -    -    - 
NET LOSS  $(372,756)  $(1,078,226)  $(1,206,097)  $(1,868,760)
                     
Net loss per share attributable to common stockholders, basic and diluted  $(0.03)  $(0.10)  $(0.11)  $(0.17)
                     
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted   11,346,535    11,337,107    11,346,535    10,682,986 

 

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, 2023

 

   Number of Shares   Amount  

Paid-in

Capital

   Accumulated Deficit   Stockholders’
Deficit
 
   Common Stock   Additional         
   Number of Shares   Amount  

Paid-in

Capital

   Accumulated Deficit   Stockholders’
Deficit
 
Balance at March 31, 2023   11,346,535   $11,346   $4,346,594-- $(5,304,622)  $(946,682)
Share-based compensation   -    -    12,626   -    12,626 
Net loss   -    -    ---  (372,756)   (372,756)
Balance at June 30, 2023   11,346,535   $11,346   $4,359,220-- $(5,677,378)  $(1,306,812)

 

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 

 

 

3

 

 

For Six Months Ended June 30, 2023

 

   Number of Shares   Amount  

Paid-in

Capital

   Accumulated Deficit   Stockholders’
Deficit
 
   Common Stock   Additional         
   Number of Shares   Amount  

Paid-in

Capital

   Accumulated Deficit   Stockholders’
Deficit
 
Balance at December 31, 2022   11,346,535   $11,346   $4,320,385-- $(4,471,281)  $(139,550)
Share-based compensation   -    -    38,835    -    38,835 
Net loss   -    -    ---  (1,206,097)   (1,206,097)
Balance at June 30, 2023   11,346,535   $11,346   $4,359,220-- $(5,677,378)  $(1,306,812)

 

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 

 

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)

 

   2023   2022 
  

For the Year Six Months Ended

June 30

 
   2023   2022 
Operating Activities          
Net loss  $(1,206,097)  $(1,868,760)
           
Adjustments to reconcile net loss to net cash (used in) provided by operating activities          
Foreign currency translation   -    (66,981)
Depreciation   1,815    1,507 
Share-based compensation   38,835    54,628 
Change in operating assets and liabilities:          
Related party receivable   -    1,353,373 
Prepaid expenses   209,293    48,168 
Other current assets   29,603    - 
Accounts payable   70,935    (279,720)
Related party payable   33,000    33,000 
Accrued expenses   (146,383)   96,278 
Net cash used in operating activities   (968,999)   (628,507)
           
Investing Activities          
Purchases of equipment   -    (10,999)
Net cash used in investing activities   -    (10,999)
           
Financing Activities          
Advances from related party   537,925    54,599 
Payments on advances from related party        

(190,838

)
Proceeds from receipt of subscription receivable   -    204,879 
Proceeds from issuance of common stock   -    2,676,127 
Payments on note payable   (182,253)   (123,751)
Net cash provided by financing activities   355,672    2,621,016 
           
(Decrease) Increase in cash   (613,327)   1,981,510 
           
Cash, beginning of period   733,978    - 
Cash, end of period  $120,651   $1,981,510 
           
Supplemental disclosure of noncash investing and financing activities          
Issuance of Note Payable for payment of prepaid expense   372,879    439,122 
           
Supplemental cash flow information          
Cash paid for interest   702    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. DESCRIPTION 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.

 

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, 2023, the Company incurred a net loss of $1,206,097. The Company has an accumulated deficit of $5,677,378 as of June 30, 2023. 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.

 

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, 2022, as filed with the SEC on February 15, 2023. 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.

 

6

 

 

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, 2023 and December 31, 2022, the Company had no cash equivalents and all cash amounts consisted of cash on deposit.

 

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.

 

Reclassification

 

Certain 2022 amounts have been reclassified, where appropriate, to conform to the 2023 presentation.

 

Recent Accounting Standards

 

Adopted Accounting Standards

 

None

 

Standards not yet adopted

 

None

 

7

 

 

3. EQUIPMENT

 

Equipment consists of the following:

  

June 30,

2023

  

December 31,

2022

 
Computer equipment  $10,999    10,999 
Less: Accumulated depreciation   5,136    3,321 
Equipment, net  $5,863    7,678 

 

Depreciation expense was approximately $907 and $830, respectively, for the three months ended June 30, 2023 and 2022, respectively. For the six months ended June 30, 2023 and 2022, respectively, depreciation expense was approximately $1,815 and $1,507, respectively.

 

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

 

4. ACCRUED EXPENSES

 

Accrued expenses consist of the following:

 

           
  

June 30,

2023

  

December 31,

2022

 
Corporate bonus  $181,735    369,528 
Legal expense   146,593    124,245 
Other   43,211    24,852 
Total accrued expenses  $371,539   $518,625 

 

5. NOTE PAYABLE

 

On May 20, 2023, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $372,880. Under the terms of the agreement, the Company made a down payment of $75,000, with the remaining balance financed over the remaining term at an annual percentage rate of 7.50%. Beginning June 2023, the Company will make 10 monthly payments of $30,822, with the last payment expected to be made in March 2024. At the end of June 30, 2023, the outstanding balance on the note payable was $297,880.

 

6. LICENSE

 

On November 9, 2022, AccuStem and the IEO/University of Milan amended the License to clarify the regulatory path and timeline for the commercialization of StemPrintER. Specifically, the regulatory requirement language has been modified to (i) extend the timeline for regulatory approval or clearance of a licensed product to 36 months from the date of the amendment, (ii) clarify that contractual regulatory requirements can be satisfied by the approval or clearance of the test as a Laboratory Developed Test (i.e., approval or clearance can be achieved via the CLIA regulatory path rather than the FDA) and (iii) the timeline for commercial launch has been extended for an additional 60 months from the date of the amendment. The amendment provides for a separate licensing payment of $175,000 to the IEO.

 

In addition, 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:$1.0675)

 

  50,000 ($53,375) within 30 days of completion of development of a commercial test;
  100,000 ($106,750) within 30 days of the first commercial sale of a licensed product; and
  150,000 ($160,125) within 30 days of first regulatory approval in the U.S. or any other major market.

 

The License may be terminated by either party in the event of a material breach and in addition, we may terminate the License at any time upon 30 days’ notice.

 

For the three and six months ended June 30, 2023 and 2022, the Company did not recognize any expense related to this license agreement.

 

8

 

 

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, 2023 and 2022, loss per share of the Company are as follows:

 

   2023   2022   2023   2022 
  

Three Months Ended

June 30

  

Six Months Ended

June 30

 
   2023   2022   2023   2022 
Numerator:                
Net Loss  $(372,756)  $(1,078,226)  $(1,206,097)  $(1,868,760)
Net loss per share attributable to common stockholders  $(372,756)  $(1,078,226)  $(1,206,097)  $(1,868,760)
Denominator:                    
Weighted average common shares outstanding, basic and diluted   11,346,535    11,337,107    11,346,535    10,682,986 
Net loss per share attributable to common stockholders, basic and diluted  $(0.03)  $(0.10)  $(0.11)  $(0.17)

 

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.

 

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, 2023 and 2022 because including them would have had an anti-dilutive effect.

 

   2023   2022   2023   2022 
  

Three Months Ended

June 30

  

Six Months Ended

June 30

 
   2023   2022   2023   2022 
Shares issuable upon exercise of stock options   1,271,015    1,406,775    1,271,015    1,406,775 
Warrants to purchase common stock outstanding   350,000    350,000    350,000    350,000 
Total   1,621,015    1,756,775    1,621,015    1,756,775 

 

8. SHARE-BASED COMPENSATION

 

In August 2021, AccuStem 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 Incentive Plan was 2,500,000. Awards under the Incentive Plan are exercisable for up to 10 years from the date of issuance. There are 1,219,552 remaining available shares to be issued under the Incentive Plan at June 30, 2023. 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

 

There were no options granted or modified for the three and six months ended June 30, 2023, and for the three months ended June 30, 2022.

 

9

 

 

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

 

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                

 

For the six months ended June 30, 2023, 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, 2023   416,115   $1.86    9.13   $57,207 
Issued                
Exercised                           
Expired/Forfeited   (39,600)   2.13         
Outstanding at June 30, 2023   376,515   $1.83    8.65   $61,534 
                     
Vested and exercisable June 30, 2023   130,840   $1.35    8.49   $57,198 

 

10

 

 

For the six months ended June 30, 2023, 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, 2023   944,000   $1.45    9.11   $174,000 
Issued                
Exercised                
Expired/Forfeited   (49,500)            
Outstanding at June 30, 2023   894,500   $1.41    8.86   $ 
                     
Vested and exercisable June 30, 2023                        

 

The aggregate intrinsic value is calculated as the difference between the estimated fair value of the underlying common stock as of June 30, 2023 and the option exercise price.

 

Total share-based compensation was approximately $12,626 and $37,588, respectively, for the three months ended June 30, 2023 and 2022, respectively. For the six months ended June 30, 2023 and 2022, respectively, share-based compensation was approximately $38,835 and $54,628, respectively.

 

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

 

There was no time based or performance -based stock option granted during the six months ended June 30, 2023.

The weighted average grant date fair value for stock options granted during the six months ended June 30, 2022 is $0.76. The performance-based and time-based stock options are equity-classified.

 

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, 2023.

 

    

Six Months Ended

June 30, 2023

    

Six Months Ended

June 30, 2022

 
Risk-free interest rate       1.54 - 2.34%
Expected dividend yield       %
Expected term       5.008.50 years 
Expected volatility       57.2 - 65.7%

  

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.

 

11

 

 

As of June 30, 2023, there was $825,591 unrecognized compensation expense related to options. $132,252 of this cost is subject to time-based conditions, and is to be recognized over a period of approximately 2.8 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, 2023 and 2022.

 

For the six months ended June 30, 2022, warrant activity of the Company are 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                       

 

For the six months ended June 30, 2023, warrant activity of the Company are as follows:

 

  

Number of

shares

  

Weighted

Average

Exercise Price

  

Weighted

average

remaining

contractual

life (in years)

  

Aggregate

Intrinsic

Value

 
Outstanding at January 1, 2023   350,000   $1.06    9.07   $ 
Issued                
Exercised                
Expired/Forfeited                
Outstanding at June 30, 2023   350,000   $1.06    8.57   $122,500 
                     
Vested and exercisable June 30, 2023                

 

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, 2023 and 2022.

  

Six Months Ended

June 30, 2023

  

Six Months Ended

June 30, 2022

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

 

12

 

 

There was no share-based compensation expense recognized during the three and six months ended June 30, 2023 and 2022 for warrants.

 

As of June 30, 2023, 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 Life Sciences Limited (“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, 2023, Tiziana owns approximately 11.8% of the Company.

 

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 March 31, 2023 and 2022, the Company has incurred approximately $4,503 and $3,318, respectively.

 

As of June 30, 2023 and December 31, 2022, $614,154 and $76,229 respectively, was also due to Tiziana, as Tiziana had paid for expenses on behalf of the Company. Subsequent to June 30, 2023, Tiziana had paid for an additional $90,000 of 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, 2023, $99,000 was due to Gabriele Cerrone.

 

10. INCOME TAXES

 

The Company recorded no provision or benefit for income tax expense for the three months ended June 30, 2023. 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.

 

The Company has no open tax audits with any taxing authority as of June 30, 2023.

 

13

 

 

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, 2022, as filed with the SEC on February 15, 2023. 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.

 

Forward-Looking Statements

 

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 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.

 

14

 

 

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.

 

Overview

 

We are a clinical stage diagnostics company dedicated to improving quality of life and outcomes for the more than 18 million people worldwide who are diagnosed with cancer each year. Our plan is to develop and commercialize a suite of novel genomic tests that support decision making along the entire continuum of oncology care. Our focus will be the commercialization of our proprietary genomic test, StemPrintER, for patients with early-stage breast cancer, and we estimate this market opportunity represents more than $1.3 billion in annual revenue.

 

Our primary product candidate is StemPrintER, a 20-gene prognostic assay intended to predict the risk of distant recurrence (“DR”) in luminal (ER+/HER2-negative) breast cancer patients. The assay was developed to measure the “stemness” of tumors, or how much a tumor behaves like stem cells which could indicate how likely a cancer is to recur or be resistant to standard treatments, ultimately impacting how patients are managed by their multi-disciplinary care team. 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

 

Beyond our initial plans for StemPrintER, we believe there is significant opportunity to expand our product portfolio. First, 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, we plan to offer ancillary commodity testing (e.g., hereditary genetic testing, somatic mutation testing) that augments our proprietary assays and provides additional information and value to patients and physicians throughout the patient care continuum.

 

We plan to launch StemPrintER once we have achieved several key milestones. First, we plan to identify or build a laboratory that will be responsible for processing, testing and reporting StemPrintER results for all commercial samples. Further, we plan to transfer the StemPrintER assay from the laboratories in which they were developed to our commercial laboratory. Finally, upon establishing testing capabilities in our commercial laboratory, 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.

 

 

15

 

 

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 $372,756 and $1,078,226 for the three months ended June 30, 2023 and 2022, respectively. We incurred net losses of $1,206,097 and $1,868,760 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of $5,677,378. 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, 2023, 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, 2023, 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, 2023 to the three and six months ended June 30, 2022:

 

  

Three Months Ended

June 30

          

Six Months Ended

June 30

         
   2023   2022   $ Change   % Change   2023   2022   $ Change   % Change 
Research and development expenses  $14,575   $54,396   $(39,821)   -73%  $30,177   $75,539   $(45,362)   -60%
General and administrative expenses   358,181    1,023,830    (665,649)   -65%   1,175,920    1,793,221    (617,301)   -34%
Loss from operations   372,756    1,078,226    (705,470)   -65%   1,206,097    1,868,760    (662,663)   -35%
Loss, before income tax   (372,756)   (1,078,226)   705,470    -65%   (1,206,097)   (1,868,760)   662,663    -35%
Income tax benefit (expense)   -    -    -    0%   -    -    -    0%
Net Loss  $(372,756)  $(1,078,226)  $705,470    -65%  $(1,206,097)  $(1,868,760)  $662,663    -35%

 

Research and development

 

Research and development expenses for the three and six months ended June 30, 2023 decreased to $14,575 and $30,177, respectively, compared to $54,396 and $75,539, respectively, for the three and six months ended June 30, 2022 primarily due to a decrease in patent related expenses, and laboratory work and consulting.

 

General and administrative

 

General and administrative expenses for the three and six months ended June 30, 2023 decreased to $358,181 and $1,175,920, respectively, compared to $1,023,830 and $1,793,221, respectively, for the three and six months ended June 30, 2022 primarily due to a decrease of payroll related costs as a result of changes in management, legal fees and other compliance expenses.

 

16

 

 

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 us. 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, 2023, our cash balance is $120,651, which is not adequate for our current planned level of operations through at least 12 months from the issuance date of these condensed consolidated financial statements.

 

Cash Flows

 

The following table summarizes our cash flows:

 

   Six Months Ended June 30, 
   2023   2022 
Cash flows used in operating activities  $(968,999)  $(628,507)
           
Cash flows used in investing activities       (10,999)
           
Cash flows provided by financing activities   355,672    2,621,016 
           
Net (decrease) increase in cash and cash equivalents   (613,327)   1,981,510 
Cash and cash equivalents at beginning of period   733,978     
Cash and cash equivalents at end of period  $120,651   $1,981,510 

 

Operating Activities

 

During the six months ended June 30, 2023, net cash used in operating activities was primarily the result of net losses, partially offset by prepaid expenses, and accrued expenses.

 

During the six months ended June 30, 2022, net cash used in operating activities was primarily the result of net losses, partially offset by the collection of a receivable from a related party.

 

Investing Activities

 

There were no cash flows from investing activities during the three months ended June 30, 2023.

 

The cash flow used in investing activities increased during the three months ended June 30, 2022 due to the purchase of computer equipment.

 

Financing Activities

 

During the three months ended June 30, 2023, net cash provided by financing activities was primarily due to advances from a related party, partially offset by payments on a note payable.

 

We generated cash flows from financing activities during the three months ended June 30, 2022 due to proceeds from the issuance of common stock to Tiziana.

 

Market Capital Expenditure Commitments

 

We have no material commitment for capital expenditures.

 

17

 

 

Funding Requirements

 

We expect that our expenses will increase and operating losses will be generated, and we have $5,677,378 of accumulated deficit as at June 30, 2023. Based on our current plans, we believe our existing cash and cash equivalents will not be sufficient to fund our operations and capital expenditure requirements through at least 12 months from the issuance date of these condensed consolidated financial statements. 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.

 

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.

 

18

 

 

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, 2022.

 

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, 2022.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15I and 15d-15(e)) as of June 30, 2023, the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other 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 time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our disclosure controls and procedures as of June 30, 2023, our management, with the participation of our principal executive officer and principal financial officer has concluded that, based on such evaluation, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective due to the material weakness described below.

 

Material Weaknesses in Internal Controls Over Financial Reporting

 

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 our annual or interim financial statements will not be prevented or detected on a timely basis.

 

Management has determined that we did not maintain effective internal control over financial reporting as of the period ended June 30, 2023 due to 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.

 

19

 

 

Management’s Plan to Remediate the Material Weakness

 

Management intends to remediate this item in the following manner:

 

i. Recruit appropriately skilled accounting resources (the “Remediation Plan”)

 

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, 2023.

 

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, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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, 2022

 

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.

 

20

 

 

Item 6. Exhibits

 

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)

 

21

 

 

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 14, 2023.

 

  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 14, 2023 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  

 

22

 

 

Exhibit 31.1

 

CERTIFICATION BY PRINCIPAL EXECUTIVE OFFICER, PRINCIPAL FINANCIAL AND

ACCOUNTING OFFICER

 

I, Wendy Blosser, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of AccuStem Sciences Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Dated: August 14, 2023

 

  /s/ Wendy Blosser  
Name: Wendy Blosser  
Title: Chief Executive Officer  

 

 

 

 

Exhibit 31.2

 

CERTIFICATION BY PRINCIPAL EXECUTIVE OFFICER, PRINCIPAL FINANCIAL AND

ACCOUNTING OFFICER

 

I, Keeren Shah, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of AccuStem Sciences Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Dated: August 14, 2023

 

  /s/ Keeren Shah  
Name: Keeren Shah  
Title: Chief Financial Officer  

 

 

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report of AccuStem Sciences Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Wendy Blosser, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

Dated: August 14, 2023

 

  /s/ Wendy Blosser  
Name: Wendy Blosser  
Title: Chief Executive Officer  

 

 

 

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Annual Report of AccuStem Sciences Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Keeren Shah, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

Dated: August 14, 2023

 

  /s/ Keeren Shah  
Name: Keeren Shah  
Title: Chief Financial Officer  

 

 

 

v3.23.2
Cover - shares
6 Months Ended
Jun. 30, 2023
Aug. 14, 2023
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2023  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2023  
Current Fiscal Year End Date --12-31  
Entity File Number 000-56257  
Entity Registrant Name ACCUSTEM SCIENCES, INC.  
Entity Central Index Key 0001850767  
Entity Tax Identification Number 87-3774438  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 5 Penn Plaza  
Entity Address, Address Line Two 19th Floor  
Entity Address, City or Town #1954 New York  
Entity Address, State or Province NY  
Entity Address, Postal Zip Code 10001  
City Area Code 00 44  
Local Phone Number 2074952379  
Trading Symbol ACUT  
Title of 12(g) Security Common Stock  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Elected Not To Use the Extended Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   11,346,535
v3.23.2
Condensed Consolidated Balance Sheets - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Current Assets    
Cash $ 120,651 $ 733,978
Prepaid expenses 332,016 168,430
Other Current Assets 29,603
Total Current Assets 452,667 932,011
Equipment, net 5,863 7,678
TOTAL ASSETS 458,530 939,689
Current Liabilities    
Accounts payable 382,769 311,834
Accrued expenses 371,539 518,625
Note Payable 297,880 106,551
Total Current Liabilities 1,765,342 1,079,239
TOTAL LIABILITIES 1,765,342 1,079,239
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; 11,346,535 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively 11,346 11,346
Additional paid-in capital 4,359,220 4,320,385
Accumulated deficit (5,677,378) (4,471,281)
TOTAL STOCKHOLDERS’ EQUITY (1,306,812) (139,550)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 458,530 939,689
Related Party [Member]    
Current Liabilities    
Related party payable $ 713,154 $ 142,229
v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Statement of Financial Position [Abstract]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 150,000,000 150,000,000
Common stock shares issued 11,346,535 11,346,535
Common stock shares outstanding 11,346,535 11,346,535
v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
OPERATING EXPENSES        
Research and development expenses $ 14,575 $ 54,396 $ 30,177 $ 75,539
General and administrative expenses 358,181 1,023,830 1,175,920 1,793,221
Total operating expenses 372,756 1,078,226 1,206,097 1,868,760
LOSS FROM OPERATIONS (372,756) (1,078,226) (1,206,097) (1,868,760)
LOSS, BEFORE TAX (372,756) (1,078,226) (1,206,097) (1,868,760)
Income tax benefit (expense)
NET LOSS $ (372,756) $ (1,078,226) $ (1,206,097) $ (1,868,760)
Net loss per share attributable to common stockholders, basic $ (0.03) $ (0.10) $ (0.11) $ (0.17)
Net loss per share attributable to common stockholders, diluted $ (0.03) $ (0.10) $ (0.11) $ (0.17)
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, basic 11,346,535 11,337,107 11,346,535 10,682,986
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, diluted 11,346,535 11,337,107 11,346,535 10,682,986
v3.23.2
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($)
Common Stock [Member]
Additional Paid-in Capital [Member]
Related Party Subscription Receivable [Member]
AOCI Attributable to Parent [Member]
Retained Earnings [Member]
Total
Beginning balance, value at Dec. 31, 2021 $ 9,999 $ 1,503,434 $ (204,879) $ 66,981 $ (724,862) $ 650,673
Beginning balance, shares at Dec. 31, 2021 9,999,132          
Share-based compensation 54,628 54,628
Net loss (1,868,760) (1,868,760)
Exercise of common stock options 187 187
Exercise of common stock options, shares 469          
Issuance of common stock $ 1,338 2,674,602 2,675,940
Issuance of common stock, shares 1,337,970          
Receipt of subscription receivable 204,879 204,879
Foreign currency translation adjustment (66,981) (66,981)
Ending balance, value at Jun. 30, 2022 $ 11,337 4,232,851 (2,593,622) 1,650,566
Ending balance, shares at Jun. 30, 2022 11,337,571          
Beginning balance, value at Mar. 31, 2022 $ 11,337 4,195,076 (1,515,396) 2,691,017
Beginning balance, shares at Mar. 31, 2022 11,337,102          
Share-based compensation 37,588 37,588
Net loss (1,078,226) (1,078,226)
Exercise of common stock options 187 187
Exercise of common stock options, shares 469          
Ending balance, value at Jun. 30, 2022 $ 11,337 4,232,851 (2,593,622) 1,650,566
Ending balance, shares at Jun. 30, 2022 11,337,571          
Beginning balance, value at Dec. 31, 2022 $ 11,346 4,320,385 (4,471,281) (139,550)
Beginning balance, shares at Dec. 31, 2022 11,346,535          
Share-based compensation 38,835     38,835
Net loss (1,206,097) (1,206,097)
Ending balance, value at Jun. 30, 2023 $ 11,346 4,359,220 (5,677,378) (1,306,812)
Ending balance, shares at Jun. 30, 2023 11,346,535          
Beginning balance, value at Mar. 31, 2023 $ 11,346 4,346,594 (5,304,622) (946,682)
Beginning balance, shares at Mar. 31, 2023 11,346,535          
Share-based compensation 12,626     12,626
Net loss (372,756) (372,756)
Ending balance, value at Jun. 30, 2023 $ 11,346 $ 4,359,220 $ (5,677,378) $ (1,306,812)
Ending balance, shares at Jun. 30, 2023 11,346,535          
v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Operating Activities    
Net loss $ (1,206,097) $ (1,868,760)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities    
Foreign currency translation (66,981)
Depreciation 1,815 1,507