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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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, 2024

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT

 

For the transition period from N/A to N/A

 

Commission File Number: 000-54986

 

ARCH THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   46-0524102
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)
   
235 Walnut Street, Suite 6    
Framingham, MA   01702
(Address of principal executive offices)   (Zip Code)

 

(617) 431-2313

Registrant’s telephone number, including area code

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
N/A   N/A   N/A

 

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, 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 19, 2024, 4,444,364 shares of the registrant’s common stock were outstanding.

 

 

 

 
 

 

ARCH THERAPEUTICS, INC.

Quarterly Report on Form 10-Q

 

Table of Contents

 

  Page No.
PART I FINANCIAL INFORMATION  
   
Item 1. Condensed Consolidated Financial Statements  
   
Condensed Consolidated Balance Sheets as of June 30, 2024 (unaudited) and September 30, 2023 F-1
   
Condensed Consolidated Statements of Operations for the Three and Nine Months ended June 30, 2024 and June 30, 2023 (unaudited) F-2
   
Condensed Consolidated Statements of Changes in Stockholders’ Deficit for the Three and Nine Months ended June 30, 2024 and June 30, 2023 (unaudited) F-3
   
Condensed Consolidated Statements of Cash Flows for the Nine Months ended June 30, 2024 and June 30, 2023 (unaudited) F-4
   
Notes to Condensed Consolidated Financial Statements (unaudited) F-5
   
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 3
   
Item 3. Quantitative and Qualitative Disclosures About Market Risk 15
   
Item 4. Controls and Procedures 15
   
PART II - OTHER INFORMATION 16
   
Item 1. Legal Proceedings 16
   
Item 1A. Risk Factors 16
   
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 16
   
Item 6. Exhibits 17

 

2
 

 

Arch Therapeutics, Inc.

Condensed Consolidated Balance Sheets

As of June 30, 2024 (Unaudited) and September 30, 2023

 

 

 

   June 30,   September 30, 
   2024   2023 
   (unaudited)     
ASSETS          
Current assets:          
Cash  $30,030   $222,720 
Inventory   1,320,276    1,364,504 
Prepaid expenses and other current assets   40,824    362,866 
Total current assets   1,391,130    1,950,090 
           
Long-term assets:          
Property and equipment, net   3,014    4,599 
Other assets   3,500    3,500 
Total long-term assets   6,514    8,099 
           
Total assets  $1,397,644   $1,958,189 
           
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
Current liabilities:          
Accounts payable  $2,916,655   $2,304,207 
Accrued expenses and other liabilities   407,242    467,496 
Insurance premium financing       243,285 
Convertible notes payable, senior secured, net of discount   6,701,720    3,519,103 
Convertible notes payable, unsecured, net of discount   2,686,501    1,658,702 
Convertible notes payable, Series 2, unsecured       450,000 
Accrued interest   1,246,092    823,128 
Total current liabilities   13,958,210    9,465,921 
           
Commitments and contingencies    -    - 
           
Stockholders’ deficit:          
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding as of June 30, 2024 and September 30, 2023        
Common stock, $0.001 par value, 350,000,000 authorized as of June 30, 2024 and September 30, 2023; 4,444,364 and 4,689,446 shares issued and outstanding as of June 30, 2024 and September 30, 2023   4,444    4,689 
Additional paid-in capital   60,026,073    54,543,188 
Accumulated deficit   (72,591,083)   (62,055,609)
Total stockholders’ deficit   (12,560,566)   (7,507,732)
           
Total liabilities and stockholders’ deficit  $1,397,644   $1,958,189 

 

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

 

F-1

 

 

Arch Therapeutics, Inc.

Condensed Consolidated Statements of Operations (Unaudited)

For the Three and Nine Months Ended June 30, 2024 and 2023

 

 

 

   2024   2023   2024   2023 
   For the three months ended   For the nine months ended 
   June 30,   June 30,   June 30,   June 30, 
   2024   2023   2024   2023 
Revenue  $30,913   $13,293   $108,646   $36,207 
Operating expenses:                    
Cost of revenues   21,079    18,529    66,240    54,882 
Selling, general and administrative expenses   875,629    870,053    2,870,163    3,225,753 
Research and development expenses   155,681    139,048    565,130    471,135 
Total operating expenses   1,052,389    1,027,630    3,501,533    3,751,770 
Loss from operations   (1,021,476)   (1,014,337)   (3,392,887)   (3,715,563)
Other (expense) income:                    
Interest expense   (671,929)   (808,770)   (2,451,309)   (1,968,274)
Financing expense   (3,961,276)       (3,961,276)    
Gain on extinguishment of derivative liabilities               1,158,197 
Total other expense, net   (4,633,205)   (808,770)   (6,412,585)   (810,077)
Net loss  $(5,654,681)  $(1,823,107)  $(9,805,472)  $(4,525,640)
Deemed dividends   (730,002)       (730,002)    
                     
Net loss attributable to common shareholders  $(6,384,683)  $(1,823,107)  $(10,535,474)  $(4,525,640)
                     
Net loss per common share - basic and diluted  $(1.44)  $(1.42)  $(2.32)  $(3.58)
Weighted common shares - basic and diluted   4,444,364    1,279,967    4,550,264    1,265,340 

 

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

 

F-2

 

 

Arch Therapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Deficit (Unaudited)

For the Three and Nine Months Ended June 30, 2024 and 2023

 

 

 

   Preferred Stock
Shares
   Amount   Common Stock
Shares
   Amount   Additional Paid-in Capital   Accumulated
Deficit
   Total Stockholders’
Deficit
 
Balance at September 30, 2023      $    4,689,446   $4,689   $54,543,188   $(62,055,609)  $(7,507,732)
Net loss                       (2,681,652)   (2,681,652)
Issuance of common stock upon conversion of convertible notes           52,918    53    587,906        587,959 
Stock-based compensation expense                   25,909        25,909 
Balance at December 31, 2023           4,742,364    4,742    55,157,003    (64,737,261)   (9,575,516)
Net loss                       (1,469,139)   (1,469,139)
Issuance of common stock upon conversion of convertible notes           2,000    2    18,278        18,280 
Issuance of warrants, net of financing costs                   148,891        148,891 
Exchange of common stock into warrants           (300,000)   (300)   300         
Balance at March 31, 2024           4,444,364    4,444    55,324,472    (66,206,400)   (10,877,484)
Net loss                       (5,654,681)   (5,654,681)
Issuance of warrants for financing                   3,961,276        3,961,276 
Deemed dividends for down round provision in warrants                   730,002    (730,002)    
Stock-based compensation expense                   10,323        10,323 
Balance at June 30, 2024      $    4,444,364   $4,444   $60,026,073   $(72,591,083)  $(12,560,566)
                                    
Balance at September 30, 2022      $    1,252,734   $1,252   $50,878,718   $(55,072,773)  $(4,192,803)
Net loss                       (1,800,056)   (1,800,056)
Stock-based compensation expense                   104,026        104,026 
Balance at December 31, 2022           1,252,734    1,252    50,982,744    (56,872,829)   (5,888,833)
Net loss                       (902,477)   (902,477)
Vesting of restricted stock           250                 
Issuance of common stock and warrants, net of financing costs           9,598    10    287,410        287,420 
Exchange of warrants into common stock           12,019    13    49,265        49,278 
Stock-based compensation expense                   68,524        68,524 
Balance at March 31, 2023           1,274,601    1,275    51,387,943    (57,775,306)   (6,386,088)
Net loss                       (1,823,107)   (1,823,107)
Issuance of common stock and warrants, net of financing costs           10,608    10    152,898        152,908 
Stock-based compensation expense                   41,259        41,259 
Balance at June 30, 2023      $    1,285,209   $1,285   $51,582,100   $(59,598,413)  $(8,015,028)

 

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

 

F-3

 

 

Arch Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows (Unaudited)

For the Three and Nine Months Ended June 30, 2024 and 2023

 

 

 

   2024   2023 
   For the Nine Months Ended 
   June 30,   June 30, 
   2024   2023 
Cash flows from operating activities:          
Net loss  $(9,805,472)  $(4,525,640)
Adjustments to reconcile net loss to cash used in operating activities:          
Depreciation   1,585    1,316 
Stock-based compensation   36,232    213,809 
Fair value of warrants issued accounted as financing expense   3,961,276     
Gain on extinguishment of derivative liabilities       (1,158,197)
Accretion of discount and debt issuance costs on convertible notes payable   1,852,588    1,480,121 
Changes in operating asset and liabilities:          
Inventory   44,228    31,910 
Prepaid expenses and other current assets   322,041    345,869 
Accounts payable   612,449    1,143,162 
Accrued interest   560,922    488,153 
Accrued expenses and other liabilities   (60,254)   (167,983)
Net cash used in operating activities   (2,474,405)   (2,147,480)
           
Cash flows from financing activities:          
Repayment of insurance premium financing   (243,285)   (247,933)
Shareholder advances related to bridge financing       1,228,015 
Proceeds from unsecured convertible notes   450,000    507,000 
Proceeds from senior secured convertible notes   2,075,000     
Net cash provided by financing activities   2,281,715    1,487,082 
           
Net decrease in cash   (192,690)   (660,398)
           
Cash, beginning of period   222,720    746,940 
           
Cash, end of period  $30,030   $86,542 
           
Non-cash financing activities:          
Exchange of Convertible notes payable, Series 2, unsecured and accrued interest into common stock  $606,239   $ 
Relative fair value of warrants issued – convertible notes payable, unsecured  $148,891   $ 
Deemed dividends on warrants upon trigger of down round provision  $730,002   $ 
Exchange of Series G and Series H warrants for common stock  $   $49,278 
Issuance of restricted stock  $   $3,019 
Fair value of warrants issued - second close  $   $256,439 
Fair value of inducement shares issued – second close  $   $25,840 
Fair value of placement agent warrants – second close  $   $28,093 
Fair value of warrants issued – third close  $   $137,252 
Fair value of inducement shares issued – third close  $   $15,656 
Conversion of shareholder advance into unsecured convertible note  $   $488,000 

 

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

 

F-4

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Arch Therapeutics, Inc. (together with its subsidiary, the “Company” or “Arch”) is a biotechnology company developing and marketing products based on our innovative AC5® self-assembling technology platform. The Company’s products are in the field of stasis and barrier applications, which includes managing wounds created during surgery, trauma or interventional care, or from disease; stopping bleeding (hemostasis); and controlling leaking (sealant).

 

Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. We believe that the disclosures contained in these condensed financial statements are adequate to make the information presented herein not misleading. These condensed financial statements should be read in conjunction with the financial statements contained in the Company’s Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC. The accompanying condensed financial statements are unaudited, but in the opinion of management contain all adjustments, including normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. The balance sheet as of September 30, 2023 is derived from the Company’s audited financial statements. The results of operations for the three and nine months ended June 30, 2024 are not necessarily indicative of the results of operations to be expected for the full fiscal year ending September 30, 2024.

 

In accordance with the “Segment Reporting” Topic of the Accounting Standards Codification, the Company’s chief operating decision maker (the Company’s President and Chief Executive Officer) determined that the Company has only one reporting unit.

 

The condensed consolidated financial statements include the accounts of Arch Therapeutics, Inc. and its wholly owned subsidiary, Arch Biosurgery, Inc., a biotechnology company. All intercompany accounts and transactions have been eliminated in consolidation.

 

Going Concern

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. As reflected in the accompanying condensed financial statements, for the nine months ended June 30, 2024, the Company recorded a net loss of $9,805,472 and used cash in operating activities of $2,474,405. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s September 30, 2023, financial statements, raised substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its current and its potential future products. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. In evaluating the going concern position of the Company, management has considered potential funding providers and believes that financing to fund future operations could be provided by equity and/or debt financing. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

 

Reverse stock split

 

On January 6, 2023, the directors of the Company authorized a reverse share split of the issued and outstanding Common Shares in a ratio of 1:200, effective January 17, 2023. Accordingly, all share and per share amounts presented herein with respect to common stock have been retroactively adjusted to reflect the above-described reverse stock split for all periods presented.

 

F-5

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Use of Estimates

 

Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expense during the reporting periods. Significant estimates include the assumptions used in the accrual for potential liabilities, the net realizable value of inventory, the valuation of debt and equity instruments, the fair value of derivative liabilities, valuation of equity instruments issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

 

Revenue

 

The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers (“ASC 606”), through a five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied.

 

The Company’s source of revenue is product sales. Contracts with customers contain a single performance obligation and the Company recognizes revenue from product sales when the Company has satisfied our performance obligation by transferring control of the product to the customers. Control of the product transfers to the customer upon shipment from the Company’s third-party warehouse. In circumstances where the transaction price is not able to be determined at the time of shipment, the Company does not recognize revenue or any receivable amount until such time that the final transaction price is established.

 

Cost of Revenue

 

Cost of revenue includes product costs, warehousing, overhead allocation and royalty expense.

 

Research and Development

 

The Company expenses internal and external research and development costs, including costs of funded research and development arrangements, in the period incurred.

 

Accounting for Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”), which requires all share-based payments be recognized in the condensed consolidated financial statements based on their fair values. In accordance with ASC 718, the Company has elected to use the Black-Scholes Option Pricing Model (the “Black-Scholes Model”) to determine the fair value of options granted and recognizes the compensation cost of share-based awards on a straight-line basis over the vesting period of the award.

 

The determination of the fair value of share-based payment awards utilizing the Black-Scholes model is affected by the fair value of the Common Stock and a number of other assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The expected life for awards uses the simplified method for all “plain vanilla” options, as defined in ASC 718-10-S99, and the contractual term for all other employee and non-employee awards. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the Company’s awards. The dividend yield assumption is based on history and the expectation of paying no dividends. Stock-based compensation expense, when recognized in the condensed consolidated financial statements, is based on awards that are ultimately expected to vest.

 

Fair Value Measurements

 

The Company measures both financial and nonfinancial assets and liabilities in accordance with FASB ASC Topic 820, Fair Value Measurements and Disclosures, including those that are recognized or disclosed in the condensed consolidated financial statements at fair value on a recurring basis. The standard created a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable inputs that reflect the Company’s own views about the assumptions market participants would use in pricing the asset or liability.

 

At June 30, 2024 and September 30, 2023, the carrying amounts of cash, accounts payables and accrued expense and other liabilities approximate fair value because of their short-term nature. The carrying amounts of the convertible notes payable, senior secured, convertible notes payable, unsecured and convertible notes payable, Series 2, unsecured, approximate fair value because borrowing rates and terms are similar to comparable market participants.

 

F-6

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Warrants

 

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company has determined that the warrants issued in June 2018 and May 2019 equity financing (see Note 3) meet the requirements for liability classification. During the nine months ended June 30, 2023, $1,158,197 was recorded to gain on extinguishment of derivative liability for the exchange of the Series G warrants and Series H warrants to 12,019 shares of common stock with a fair value of $49,278.

 

Loss per Common Share

 

Basic earnings (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding during the year, excluding shares of unvested restricted common stock. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from the time they vest. Diluted earnings (loss) per share is computed by dividing the net income applicable to common stockholders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. Shares of restricted stock are included in the diluted weighted average number of common shares outstanding from the date they are granted. Potential common shares are excluded from the computation when their effect is antidilutive.

 

For the three and nine months ended June 30, 2024, the Company recorded a deemed dividend of $730,002 as a result of a triggered down-round feature in the Company’s warrants, and as a result, the amount was reflected as an increase to the net loss attributed to common shareholders in the basic EPS calculation.

 

  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
   For the three months ended   For the nine months ended 
  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
                 
Net loss  $(5,654,681)  $(1,823,107)  $(9,805,472)  $(4,525,640)
Deemed dividend   (730,002)       (730,002)    
Net loss attributed to common shareholders, numerator, basic computation  $(6,384,683)  $(1,823,107)  $(10,535,474)  $(4,525,640)

 

For the periods ended June 30, 2024 and 2023, the calculations of basic and diluted loss per share are the same because potentially dilutive securities would have had an anti-dilutive effect. The potentially dilutive securities consisted of the following:

 

  

June 30,

2024

  

June 30,

2023

 
         
Stock options   88,275    104,325 
Stock warrants   29,736,656    988,417 
Convertible notes payable   18,776,444    798,675 
Total   48,601,375    1,891,417 

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash. The Company maintains its cash in bank deposits accounts, which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash.

 

Risks and uncertainties – Geopolitical Conflicts

 

The Company sources its materials and services for its products and product candidates from facilities in areas impacted or which may be impacted by the outbreak of geopolitical conflicts. The Company’s ability to obtain future inventory may be impacted, therefore potentially affecting the Company’s future revenue stream. In addition, the Company has historically and principally funded its operations through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of Common Stock and warrants which may also be impacted by economic conditions beyond the Company’s control as well as uncertainties resulting from geopolitical conflicts. The extent to which recent events, including recent wars in Ukraine and Israel/Gaza, will impact the global economy and the Company is uncertain and cannot be reasonably measured.

 

F-7

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

2. INVENTORIES

 

Inventories consist of the following:

 

   June 30,   September 30, 
   2024   2023 
Finished Goods  $56,663   $40,969 
Goods-in-Process   1,263,613    1,323,535 
Total  $1,320,276   $1,364,504 

 

Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out (“FIFO”) basis. The cost of inventories comprises expenditures incurred in acquiring the inventories, the cost of conversion and other costs incurred in bringing them to their existing location and condition. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. Once inventory has been written down, it creates a new cost basis for inventory that may not be subsequently written up. For the periods ended June 30, 2024 and 2023, the Company did not record any write-down of inventories.

 

3. WARRANT DERIVATIVE LIABILITY

 

As of June 30, 2024 and September 30, 2023, there are no financial instruments accounted as a derivative liability.

 

The Company previously issued warrants (Series G and Series H warrants) that were accounted for the in accordance with ASC 815-10 as the Company is required to purchase the Series G, and Series H warrants for an amount of cash per share equal to $22.00 and $10.66, respectively, (the “Minimum Value”). Accordingly, the warrants were recorded as liabilities at the greater of the Minimum Value or fair value at each reporting period.

 

During the nine months ended June 30, 2023, the Company issued 12,019 shares of common stock with a fair value of $49,278 in exchange for the cancellation of the Series G and Series H warrants. As a result, during the three-month ended March 31, 2023, the Company recorded a gain of $1,158,197 to account for the extinguishment of derivative liability.

 

4. CONVERTIBLE NOTES PAYABLE, SENIOR SECURED

 

  

June 30,

2024

  

September 30,

2023

 
Senior Secured Convertible Promissory Notes (the “2022 Notes”)  $4,211,720   $4,230,000 
Senior Secured Convertible Promissory Notes (the “2024 First Notes”)   2,490,000     
Unamortized debt discount       (710,897)
Net balance  $6,701,720   $3,519,103 

 

2022 Notes

 

In July 2022, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain institutional and accredited individual investors and issued Senior Secured Convertible Promissory Notes (the “2022 Notes”) in the aggregate of $4,230,000 in exchange for cash proceeds of $3,525,000, net of original issue discount (OID) of $705,000.

 

The 2022 Notes are secured by tangible and intangible assets of the Company, bears interest at a rate of 10% per annum payable at maturity or upon conversion, matures on September 15, 2024, as amended.

 

Repricing of conversion price

 

The 2022 Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that lowers the conversion price if the Company sells shares of common stock or issues convertible debt convertible at a lower price per share. In May and June 2004 the Company issued notes (the “2024 First Notes”, see below) convertible into common stock of the Company at an exercise price of $0.50 per share, resulting in a triggering event lowering the conversion price of the 2022 Notes to $0.50 per share. The Company adopted ASU 2020-06 on October 1, 2022, and following the guidance of ASU 2020-06, no discount was recorded for any incremental value created by the triggering event.

 

Other

 

The 2022 Notes contain customary events of default such as automatic increase in the notes’ stated interest rate. Further, events of default under the 2022 Notes also include (i) the unavailability of Rule 144 on or after January 6, 2023; (ii) our failure to deliver the shares of common stock to the 2022 Note holder upon exercise by such holder of its conversion rights under the 2022 Note; (iii) our loss of the “bid” price for its common stock and/or a market and such loss is not cured during the specified cure periods; and (iv) our failure to complete an uplisting of our Common Stock to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American by April 30, 2024 (the “Uplist Transaction”). During the year ended September 2023, for no additional consideration, the 2022 Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date for the Uplist Transaction, and amend certain provisions with regards to mandatory conversion of the notes upon the Uplist Transaction.

 

F-8

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

In connection with the issuance of the 2022 Notes, the Company granted the 2022 Notes noteholders 425,555 warrants to purchase shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company estimated the relative fair value of the warrants to be $1,470,000 using the Black Scholes option pricing model. The Company also issued note holders 63,834 shares of the Company’s common stock with a relative fair value of $315,000. The Company also issued 31,510 warrants to purchase shares of common stock to the placement agent that assisted in the 2022 Notes offering. The placement agent warrants are fully vested, exercisable at $10.06 per share and will expire in 5 years. The Company estimated the relative fair value of the placement agent warrants to be $108,000 using the Black Scholes option pricing model. The Company incurred direct legal and professional fees of $271,000 as part of this offering.

 

The Company recorded 2022 Notes with total principal of $4,230,000. In addition, total debt discount of $2,870,000 was recorded to account for the 2022 Notes OID of $705,000, the relative fair value of the warrants of $1,578,000, the relative fair value of common stock issued of $315,000, and direct legal and professional fees incurred in the 2022 Notes offering of $271,000. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

Subsequent to issuance, for no additional consideration, the 2022 Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction.

 

On February 14, 2024, the Company entered into an amendment to the 2022 Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the 2022 Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the 2022 Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

As of September 30, 2023, outstanding balance of the 2022 Notes payable was $4,230,000 and unamortized debt discount was $710,897, or a net balance of $3,519,103. On December 26, 2023, the Company issued a total of 2,000 shares of Common Stock with a fair value of $18,280 in partial satisfaction of the outstanding Senior Secured Convertible Promissory Notes with the principal balance of $18,280. During the nine months ended June 30, 2024, the Company amortized debt discount of $710,897. As of June 30, 2024, the outstanding balance of the 2022 Notes payable amounted to $4,211,720 and no unamortized debt discount was remaining.

 

2024 First Notes

 

In May and June 2024, the Company issued senior secured convertible promissory notes (the “2024 First Notes”) in the aggregate of $2,490,000 in exchange for cash of $2,075,000, net of original issue discount (OID) of $415,000. The 2024 First Notes are secured by the Company’s tangible and intangible assets, bears interest at a rate of 10% per annum, convertible to common stock at a conversion price of $0.50 per share. The 2024 First Notes originally matured June 30, 2024, and were amended to mature on August 15, 2024. The OID was recorded as a debt discount and was amortized in full to interest expense over the original term of the notes payable.

 

The 2024 First Notes also contain customary events of default similar to the 2022 Notes. Furthermore, upon the closing of a transaction that results in the Uplist of the Company’s common stock to a national exchange, 100% of the outstanding principal of the 2024 First Notes will automatically convert into shares of common stock at a conversion price of $0.515625 per share. In addition, each Note Holder shall receive (i) a warrant to purchase a number of shares of common stock equal to the number of shares of common stock issued upon automatic conversion following the Uplist transaction with an exercise price of $0.50 per share and (ii) pre-funded warrants in lieu of common shares otherwise issuable to each Note Holder with an exercise price of $0.000125.

 

On June 30, 2024, the 2024 First Notes were amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the 2024 First Notes were amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

During the three and nine months ended June 30, 2024, the Company amortized debt discount of $415,000. As of June 30, 2024, the outstanding balance of the 2024 First Notes amounted to $2,490,000 and no unamortized debt discount was remaining.

 

F-9

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

5. CONVERTIBLE NOTES PAYABLE, UNSECURED

 

  

June 30,

2024

  

September 30,

2023

 
Exchanged notes (July 2022)  $699,781   $699,781 
Second closing notes (January 2023)   636,000    636,000 
Third closing notes (March, April, May, 2023)   702,720    702,720 
Fourth closing notes (March 2024)   648,000     
Total   2,686,501    2,038,501 
Unamortized debt discount       (379,799)
Net balance  $2,686,501   $1,658,702 

 

Exchanged Notes (July 2022)

 

In relation to the issuance of the 2022 Notes (see Note 4), certain noteholders of the Company’s Series 2 note payable agreed to exchange their Series 2 notes payable consisting of $600,000 principal and accrued interest of $99,781 for $699,781 of Unsecured Convertible Promissory Notes (the “Exchanged Notes”) on substantially the same terms as the 2022 Notes, except that the Exchanged Notes are subordinate to the 2022 Notes and are unsecured. The notes bear interest at a rate of 10% per annum payable at maturity or upon conversion, mature September 15, 2024, as amended. The Exchanged Notes also contain customary events of default similar to the 2022 Notes (see Note 4). The Exchanged Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

Subsequent to issuance, for no additional consideration, the Exchanged Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction. On June 30, 2024, the Exchanged Notes were again amended in order to extend the maturity date to August 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Exchanged Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Second Closing Notes (January 2023)

 

In January 2023, the Company issued Unsecured Convertible Promissory Notes (the “Second Closing Notes”) in the aggregate of $636,000 in exchange for cash proceeds of $530,000, net of original issue discount (OID) of $106,000. The notes are unsecured, bear interest at a rate of 10% per annum, matures on September 15, 2024, as amended. The Second Closing Notes also contain customary events of default similar to the 2022 Notes (see Note 4). The Second Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Second Closing Notes, the Company granted the Second Closing Notes noteholders 127,968 warrants to purchase shares of common stock and 9,589 shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company determined the relative fair value of the warrants to be $256,000 and the relative fair value of the 9,598 shares of common stock to be $26,000. The Company also issued 6,565 placement agent warrants to purchase shares of the Company’s common stock. The placement agent warrants are fully vested, exercisable at $10.06 per share and will expire in 5 years. The Company determined the relative fair value of the placement agent warrants to be $13,000. Furthermore, the Company also incurred direct legal and professional fees of $31,000 as part of this offering.

 

The Company recorded debt discount totaling $432,000 to account for the direct legal and professional fees, OID and the relative fair value of the warrants and common stock. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

On February 14, 2024, the Company entered into an amendment to the Second Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the Second Closing Notes were again amended in order to extend the maturity date to August 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Second Closing Notes were again amended in order to extend the maturity date to September 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Third Closing Notes (March, April and May 2023)

 

In March, April and May 2023, the Company issued Unsecured Convertible Promissory Notes (the “Third Closing Notes”) in the aggregate of $702,720 in exchange for cash proceeds of $488,000, net of original issue discount (OID) of $215,000, and. The notes are unsecured, bear interest at a rate of 10% per annum, matures on June 30, 2024, as amended . The Third Closing Notes contain events of default similar to the 2022 Notes. The Third Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Third Closing Notes, the Company granted the Third Closing Notes noteholders 141,396 warrants to purchase shares of common stock and 10,608 shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company determined the relative fair value of the warrants to be $164,000, and the relative fair value of the 10,608 shares of common stock to be $18,000. The Company also incurred direct legal and professional fees of $5,000 as part of this offering.

 

The Company recorded debt discount totaling $402,000 to account for the direct legal and professional fees, OID and the relative fair value of the warrants and common stock. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

Subsequent to issuance, for no additional consideration, the Third Closing Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction.

 

F-10

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

On February 14, 2024, the Company entered into an amendment to the Third Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the Third Closing Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Third Closing Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Fourth Closing Notes (March 2024)

 

On March 12, 2024, investors agreed to purchase Unsecured Convertible Promissory Notes (the “Fourth Closing Notes”) in the aggregate principal amount of $648,000 in exchange for cash proceeds of $450,000, net of an OID of $198,000. The notes are unsecured, bears interest at a rate of 10% per annum. The Forth Closing Notes originally matured June 30, 2024, and were amended to mature on August 15, 2024. The Forth Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Fourth Closing Notes, the Company granted the Fourth Closing Notes noteholders 130,383 warrants to purchase shares of common stock and 9,782 pre-funded warrants. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years, and prefunded warrants have similar terms, however, are exercisable at $0.001 per share. The Company determined the relative fair value of the warrants and pre-funded warrants to be approximately $148,891.

 

The Company recorded debt discount totaling $346,891 to account for the OID and the relative fair value of the warrants. During the three months ended June 30, 2023, the debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

On February 14, 2024, the Company entered into an amendment to the Forth Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price per share of $0.50.

 

On June 30, 2024, the Fourth Closing Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Fourth Closing Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

6. CONVERTIBLE NOTES PAYABLE, SERIES 2

 

  

June 30,

2024

  

September 30,

2023

 
Series 2 Convertible Notes (converted in November 2023)  $   $450,000 

 

On November 6, 2020, the Company issued its unsecured Series 2 10% Convertible Notes Payable in exchange for cash proceeds of $450,000.

 

On November 30, 2023, upon maturity, the Series 2 Convertible Notes of $450,000 and outstanding accrued interest of $137,946, were converted into 52,918 shares of the Company’s common stock.

 

7. STOCKHOLDERS DEFICIT

 

Common Stock

 

In January 2024 certain shareholders of the Company exchanged a total of 300,000 shares of Company’s Common Stock for 300,073 of pre-funded warrants to purchase shares of Common Stock. At the date of the exchange, the fair value of the common stock received approximates the fair value of the warrants issued. The pre-funded warrants are fully vested, exercisable at $0.001 per share, and expire in 5 years.

 

2013 Stock Incentive Plan

 

On September 1, 2023, a majority of shareholders approved the 2023 Stock Plan with 455,169 common shares reserved to be issued under the plan. As of June 30, 2024, there were no issuances under the new plan.

 

On June 18, 2013, the Company established the 2013 Stock Incentive Plan (the “2013 Plan”). Under the 2013 Plan, the Company can issue or grant a total of 185,571 shares, as amended. On June 18, 2023, the 2013 Stock Incentive Plan expired, and no shares are available for grants under the 2013 Plan.

 

F-11

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Common Stock Options

 

Stock compensation activity under the 2013 Plan for the nine months ended June 30, 2024 follows:

 

  

Option

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   102,125   $38.00    5.58   $ 
Awarded                
Forfeited/Cancelled   (1,825)   (67.00)        
Outstanding at December 31, 2023   100,300    38.00    4.00    11,000 
Awarded                
Forfeited/Cancelled   (12,025)   (58.00)        
Outstanding at March 31, 2024   88,275   $35.00    5.00     
Awarded                
Forfeited/Cancelled   (250)   (58.00)        
Outstanding at June 30, 2024   88,025    35.00    4.00     
Vested at June 30, 2024   77,812   $40.00    3.25     

 

During the nine months ended June 30, 2024 and 2023, the Company recorded stock compensation expense of $36,232 and $210,789 to account the fair value of the stock options that vested.

 

As of June 30, 2024, there is approximately $34,397 of unrecognized compensation expense related to unvested stock-based compensation arrangements granted under the 2013 Plan. The unrecognized compensation expense will be recognized over a weighted average vesting period of 1.18 years.

 

Common Stock Warrants

 

Common Stock Warrants activity for the nine months ended June 30, 2024 follows:

 

SCHEDULE OF STOCK WARRANTS ACTIVITY

  

Warrant

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   26,284,002   $0.85    4.80   $13,958,846 
Awarded                
Forfeited/Cancelled                
Outstanding at December 31, 2023   26,284,002    0.74    4.51    170,879,690 
Awarded   440,238    0.15    4.75      
Forfeited/Cancelled                
Outstanding at March 31, 2024   26,724,240   $0.73    4.28    32,897,525 
Awarded   3,012,416    0.10    4.89      
Forfeited/Cancelled                
Outstanding at June 30, 2024   29,736,656   $0.67    4.12   $15,092,000 
Vested at June 30, 2024   29,736,656   $0.67           

 

During the three months ended June 30, 2024, the Company issued warrants to purchase an aggregate of 3,012,416 shares of common stock to a number of investors as compensation for participation in debt and equity financing activities of the Company. The warrants were valued as of the dates of the issuances using the Black-Scholes Model, resulting an aggregate fair value of $3,961,276, which was recorded as financing expense. The warrants have exercise prices ranging between $0.000125 and $0.50 per share, have a term of 5 years, and are exercisable immediately.

 

Warrant Repricing

 

The Company had 29,736,656 warrants outstanding, including 19,661,911 warrants with exercise prices above $0.50 per share that were subject to a down-round anti-dilution provision. In May 2024 the Company issued notes (the “2024 First Notes”, see Note 4) convertible into common stock of the Company at an exercise price of $0.50 per share, resulting in a triggering event lowering the conversion price of the 19,661,191 warrants to $0.50 per share. When a down round provision is triggered, a financial impact due to the difference between the fair value of the warrants post-adjustment and their fair value immediately prior to the adjustment is recognized as deemed dividends. As a result, the Company recorded deemed dividends of $730,002 in our condensed consolidated financial statements for the three month and nine-month periods ended June 30, 2024.

 

Restricted Stock

 

For the three months ended June 30, 2024 and 2023, compensation expense recorded for the restricted stock awards was approximately $0, respectively. For the nine months ended June 30, 2024 and 2023, compensation expense recorded for the restricted stock awards was approximately $0 and $3,000, respectively.

 

As of June 30, 2024, there was no unrecognized compensation expense related to unvested restricted stock.

 

8. COMMITMENTS AND CONTINGENCIES

 

Periodically, the Company reviews the status of any significant matters that exist and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.

 

As of June 30, 2024, and September 30, 2023, no amounts have been accrued related to such matters.

 

9. SUBSEQUENT EVENTS

 

In July 2024, investors agreed to purchase Secured Convertible Promissory Notes (“the Fourth and Fifth Closing 2024 Notes”) in the aggregate principal amount of $264,000 in exchange for cash proceeds of $220,000, net of an OID of $44,000. These notes are secured by tangible and intangible assets of the Company, bears interest at rate of 10% per annum, convertible to common stock at a conversion rate of $0.50 and will mature on August 15, 2024.

 

In July 2024, the Company executed a loan agreement of approximately $230,000 to finance the Company’s insurance premiums for fiscal years 2024 and 2025. The loan is secured by the Company’s tangible and intangible assets, bears interest at a rate of 8.48% per annum, payable on a monthly installment basis of approximately $24,000 and will mature July 2025.

 

In August 2024, investors agreed to purchase Secured Convertible Promissory Notes (“the Sixth Closing 2024 Notes”) in the aggregate principal amount of $105,000 in exchange for cash proceeds of $87,500, net of an OID of $17,500. These notes are secured by tangible and intangible assets of the Company, bears interest at rate of 10% per annum, convertible to common stock at a conversion rate of $0.50 and will mature on August 15, 2024.

 

In August 2024, the Company also entered into Amendment No. 18 to the First 2022 Notes, Amendment No. 18 to the Second 2022 Notes, Amendment No. 13 to the Third 2022 Notes, Amendment No. 4 to the Fourth 2022 Notes, and Amendment No. 2 to the First 2024 Notes (together, the “Amendments to the Notes”). Under the Amendments to the Notes, the First 2022 Notes, Second 2022 Notes, Third 2022 Notes, Fourth 2022 Notes, and First 2024 Notes (which, for the avoidance of doubt, are the first through sixth closings of the First 2024 Notes) (together, the “Notes”) were amended to extend the date of the completion of an “Uplist” (as defined therein) and to extend the respective maturity date of each of the Notes from August 15, 2024 to September 15, 2024.

 

F-12

 

 

Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

References in this Quarterly Report on Form 10-Q (this Quarterly Report, or this Report) to Arch Biosurgery, Inc.” “Company, we, us, our, Archor similar references mean Arch Therapeutics, Inc. and its condensed consolidated subsidiary, Arch Biosurgery, Inc. References to the “SEC” refer to the U.S. Securities and Exchange Commission.

 

Forward Looking Statements

 

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated condensed financial statements and the related notes included elsewhere in this Report. Our consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words expect,” “anticipate,” “intend,” “believe,or similar language. All forward-looking statements included in this Report are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading Risk Factorsincluded Part I, Item 1A of our Annual Report on Form 10-K for the year ended September 30, 2022 (the “Annual Report”), as well as in Item II, Part 1A of this Report. Readers are cautioned not to place undue reliance on these forward-looking statements.

 

AC5, AC5-G, AC5-V, AC5-P, Crystal Clear Surgery, NanoDrape and NanoBioBarrier and associated logos are trademarks and/or registered trademarks of Arch Therapeutics, Inc. and its subsidiary. For purposes herein, references to regulatory approval and marketing authorization may be used interchangeably.

 

Corporate Overview

 

Arch Therapeutics, Inc. (together with its subsidiary, the “Company” or “Arch”) is a biotechnology company developing and marketing products based on our innovative AC5® self-assembling technology platform. Arch arose from the June 26, 2013 merger (the “Merger”) of three entities previously known as Arch Biosurgery, Inc., Almah, Inc., and Arch Acquisition Corporation, respectively.

 

Almah, Inc., was incorporated under the laws of the State of Nevada on September 16, 2009 and, as part of the Merger transaction, changed its name to Arch Therapeutics, Inc. and abandoned both its prior business plan and operations in order to adopt those of ABS.

 

Arch Acquisition Corporation, or Merger Sub, was a wholly owned subsidiary of Almah, Inc., formed for the purpose of the Merger transaction, pursuant to which Merger Sub merged with and into ABS, and ABS thereafter became the wholly owned subsidiary of the Company. The ticker symbol under which its Common Stock trades changed from “AACH” to “ARTH”, accordingly.

 

The Company’s principal offices are located in Framingham, Massachusetts.

 

The Company has recently devoted a substantial part of its operational effort to the market adoption and commercial sales of AC5® Advanced Wound System, its first product. To date, the Company has principally raised capital through debt borrowings, the issuance of convertible debt, the issuance of units consisting of the Company’s common stock, $0.001 par value per share (“Common Stock”) and warrants to purchase Common Stock (“warrants”).

 

The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its potential products. However, there can be no assurance that the Company will be successful in securing additional resources when needed, on terms acceptable to the Company, if at all. Therefore, there exists substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments related to the recoverability of assets that might be necessary despite this uncertainty.

 

Business Overview

 

We are a biotechnology company marketing and developing a number of products based on our innovative AC5® self-assembling technology platform. We believe these products can be important advances in the field of stasis and barrier applications, which includes managing wounds created during surgery, trauma or interventional care, or from disease; stopping bleeding (hemostasis); and controlling leaking (sealant). We have recently devoted a substantial part of our operational effort to the market adoption and commercial sales of AC5 Advanced Wound System, our first product. Our goal is to make care faster and safer for patients by providing products for use on external wounds, which we refer to as Dermal Sciences applications, and products for use inside the body, which we refer to as BioSurgery applications.

 

3

 

 

Core Technology

 

Our flagship products and product candidates are derived from our AC5 self-assembling peptide (SAP) technology platform and are sometimes referred to as AC5 or the “AC5 Devices.” These include AC5 Advanced Wound System and AC5 Topical Hemostat, which have received marketing authorization as medical devices in the United States (US) and the European Union (EU), respectively, and which are intended for external applications, such as management of complicated chronic wounds and acute surgical wounds. Marketing for AC5 Topical Hemostat in the EU has not initiated. Other products are in development for use in minimally invasive or open surgical procedures, and include, for example, AC5-G™ for gastrointestinal endoscopic procedures, and AC5-V® and AC5 Surgical Hemostat for hemostasis inside the body, all of which are currently investigational devices limited by law to investigational use.

 

Products based on the AC5 platform contain a proprietary biocompatible peptide that is synthesized from proteogenic, naturally occurring L-amino acids. Unlike products that contain traditional peptide sequences, when applied to a wound, AC5-based products intercalate into the interstices of the tissue and self-assemble (i.e., self-build) into a protective physical-mechanical nanoscale structure that can provide a barrier to leaking substances, such as blood, while also acting as a biodegradable scaffold that enables healing. Self-assembly is a central component of the mechanism of action of our technology. Individual AC5 peptide units readily build themselves, or self-assemble, into an ordered network of nanofibrils when in aqueous solution by the following process:

 

  Peptide strands line up with neighboring peptide strands, interacting via hydrogen bonds (non-covalent bonds) to form a ribbon-like structure called a beta sheet.
     
   This process continues such that hundreds of strands organize with charged and polar side chains oriented on one face and non-polar side chains oriented on the opposite face of the beta sheets.
     
   Interactions of the resulting structure with water molecules and ions results in formation nanofibrils, which extend in length and can join together to form larger nanofibers.
     
   This network of AC5 peptide nanofibers forms the semi-solid physical-mechanical barrier that interacts with the extracellular matrix, is responsible for sealant, hemostatic and/or other properties, that may be observed even in the presence of antithrombotic agents (i.e., blood thinners), and which subsequently becomes the scaffold that supports the repair and regeneration of damaged tissue.

 

Based on the intended application, we believe that the underlying AC5 SAP technology can impart important features and benefits to our products that may include, for instance, stopping bleeding (hemostasis), mitigating contamination, modulating inflammation, donating moisture, and enabling an appropriate wound microenvironment conducive to healing. Furthermore, we believe that AC5 SAP technology permits cell and tissue growth and is self-healing, in that it can dynamically self-repair around migrating cells. For instance, AC5 Advanced Wound System, which is indicated for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds, is shipped and stored at room temperature, is applied directly as a liquid, can conform to irregular wound geometry, self-assembles into a wound care matrix that can provide clinicians with multi-modal support, and does not possess sticky or glue-like handling characteristics. We believe these properties enhance its utility in several settings and contribute to its user-friendly profile.

 

We believe that our technology lends itself to a range of potential applications for wounds inside or on the body, including those for which a hemostatic agent or sealant is needed. For instance, the results of certain preclinical and clinical investigations that either we have conducted, or others have conducted on our behalf, have shown quick and effective hemostasis with the use of AC5 SAP technology, and that time to hemostasis (THH) is comparable among test subjects regardless of whether such test subject had or had not been treated with therapeutic doses of anticoagulant or antiplatelet medications, commonly called blood thinners. Furthermore, the transparency and physical properties of certain AC5 Devices may enable a surgeon to operate through it in order to maintain a clearer field of vision and prophylactically stop or lessen bleeding as surgery starts, a concept that we call Crystal Clear Surgery™. An example of a product that contains related features and benefits is AC5 Topical Hemostat, which is indicated for use as a dressing and to control mild to moderate bleeding, each during the management of injured skin and the micro-environment of an acute surgical wound. AC5 Topical Hemostat has not yet been marketed in Europe but has received marketing authorization.

 

Sales and marketing efforts for our AC5 Advanced Wound System, which has received 510(k) marketing clearance from the FDA, address the demand for improved solutions to treat challenging chronic and acute surgical wounds, with a particular early focus on diabetic foot ulcers, venous leg ulcers and pressure ulcers. Chronic wounds are typically defined as wounds that have not healed after four weeks of standard care. Approximately 4 million to 6.5 million new onset chronic wounds are estimated to occur in the US annually, including approximately 700,000 to 2 million diabetic foot ulcers, 2.5 million pressure ulcers, and 1.2 million venous leg ulcers. If untreated, improperly treated or unresponsive to treatment, these wounds can ultimately lead to amputation. The 5-year mortality rate among patients with chronic wounds, especially after an amputation, is significant.

 

Published data on AC5 Advanced Wound System shows encouraging outcomes, including limb salvage (avoided limb loss), among patients with multiple co-morbidities and challenging chronic wounds that failed to heal despite treatment with either traditional or other advanced wound care modalities over prolonged periods of time.

 

4

 

 

Operations

 

We rely on both an internal commercial team and independent sales distributors to drive awareness and adoption of AC5 Advanced Wound System in several targeted channels with a particular focus on physician offices and government channels, such as Veterans Health Administration (VA) hospitals and military treatment facilities. We anticipate that material growth in the physician office setting will require product reimbursement. To that end, we applied to the Centers for Medicare and Medicaid Services (CMS) for a dedicated Healthcare Common Procedure Coding System (HCPCS) Level II reimbursement code specific to AC5 Advanced Wound System to better enable providers to bill third party payors for AC5 that is used in doctors’ offices. The unique HCPCS code, A2020, was granted and made effective on April 1, 2023.

 

In support of the government market, we partnered with Lovell Government Services (LGS), a service-disabled veteran-owned small business, to be our government channel distributor. As a direct result of our relationship with LGS, AC5 Advanced Wound System has been added to the four major government contracting vehicles: Federal Supply Schedule (FSS), General Services Administration (GSA) schedule, Defense Logistics Agency’s Medical Electronic Catalog Program (ECAT), and Distribution and Pricing Agreement (DAPA). This listing enables purchase by federal government agencies, including the Department of Veterans Affairs (VA), Indian Health Services (IHS), and Department of Defense (DOD) Medical Treatment Facilities, and allows doctors in government channels to order AC5 Advanced Wound System.

 

We will continue to seek partnerships with reputable, value-added independent sales distributors on a case-by-case basis to expand the overall reach and footprint of its total sales organization. Presently, our commercialization efforts and resources remain dedicated to the US market for advanced wound care.

 

Much of our operational efforts to date, which we often perform in collaboration with partners, have included selecting compositions and formulations for our initial products; conducting preclinical studies, including safety and other tests; conducting a human trial for safety and performance of AC5; developing and conducting a human safety study to assess for irritation and sensitization potential; securing marketing authorization for our first product in the United States and in Europe; supporting surgeons performing clinical case studies; obtaining post-marketing clinical data; developing, optimizing, and validating manufacturing methods and formulations, which are particularly important components of self-assembling peptide development; developing methods for manufacturing scale-up, reproducibility, and validation; engaging with regulatory authorities to seek early regulatory guidance as well as marketing authorization for our products; sourcing and evaluating commercial partnering opportunities in the United States and abroad; and developing and protecting the intellectual property rights underlying our technology platform.

 

Our long-term business plan includes the following goals:

 

  growing revenues and building upon recent commercial momentum by driving product awareness, continued adoption and favorable payment policies for AC5 Advanced Wound System with the now-effective CMS Level II HCPCS code dedicated to the AC5;
     
   conducting biocompatibility, pre-clinical, and clinical studies on our products and product candidates;
     
   obtaining additional marketing authorization for products in the United States, Europe, and other jurisdictions as we may determine;
     
   continuing to develop third party relationships to manufacture, distribute, market and otherwise commercialize our products;
     
   continuing to develop third party relationships to collaborate on product research and development;
     
   expanding and maintaining protection of our intellectual property portfolio; and
     
   developing additional product candidates in Dermal Sciences, BioSurgery, and other areas.

 

5

 

 

To support our long-term business goals, we expect to focus on the following activities during the next twelve months:

 

  further develop our product clinical profile;
     
   enhance product packaging features;
     
   identify and address opportunities for supply chain efficiencies;
     
   assess our technology platform in order to identify and select product candidates for potential advancement into development;
     
   seek additional funding as required to support the previously described milestones necessary to support our operations;
     
   continue to expand and enhance our financial and operational reporting and controls;
     
   pursue commercial partnerships; and
     
   expand and enhance our intellectual property portfolio by filing new patent applications, obtaining allowances on currently filed patent applications, and/or adding to our trade secrets in self-assembly, manufacturing, analytical methods and formulation, as appropriate.

 

In addition to capital required for operating expenses, depending upon input from regulatory authorities, authorized representatives, patent and trademark offices, or other agencies in the US, EU or elsewhere, as well as for potential additional regulatory filings and approvals during the approximately next two years, additional capital will be required.

 

We have no commitments for any future capital. As indicated above, we will require significant additional financing to fund our planned operations, including further research and development relating to AC5, seeking regulatory approval of that or any other product we may choose to develop, commercializing any product for which we are able to obtain regulatory approval or certification, seeking to license or acquire new assets or business, and maintaining our intellectual property rights, pursuing new technologies and for financing the investor relations and incremental administrative costs associated with being a public corporation. We do not presently have, nor do we expect in the near future to have, sufficient revenue to fund our business from operations, and we will need to obtain substantially all of our necessary funding from external sources for the foreseeable future. We may not be able to obtain additional financing on commercially reasonable or acceptable terms when needed, or at all. If we cannot raise the money that we need in order to continue to develop our business, we will be forced to delay, scale back or eliminate some or all of our proposed operations. If any of these were to occur, there is a substantial risk that our business would fail, and our stockholders could lose all of their investment.

 

Since inception, we have funded our operations primarily through debt borrowings, the issuance of convertible debt and the issuance of units consisting of Common Stock and warrants, and we may continue to seek to do so in the future. If we obtain additional financing by issuing equity securities, our existing stockholders’ ownership will be diluted. The terms of securities we may issue in future capital-raising transactions may be more favorable for our new investors. Further, newly issued securities may include preferences, superior voting rights and the issuance of warrants or other derivative securities, which may have additional dilutive effects. If we obtain additional financing by incurring debt, we may become subject to significant limitations and restrictions on our operations pursuant to the terms of any loan or credit agreement governing the debt. Further, obtaining any loan, assuming a loan on acceptable terms would be available when needed, would increase our liabilities and future cash commitments. We may also seek funding from additional collaboration or licensing arrangements in the future, which may require that we relinquish potentially valuable rights to our product candidates or proprietary technologies or grant licenses on terms that are not favorable to us. Moreover, regardless of the manner in which we seek to raise capital, we may incur substantial costs in those pursuits, including investment-banking fees, legal fees, accounting fees, printing and distribution expenses and other related costs.

 

The estimated capital requirements potentially could increase significantly if a number of risks relating to conducting these activities were to occur, including without limitation those set forth under the heading “RISK FACTORS” in our Annual Report. We anticipate that our operating and other expenses will continue to increase as we continue to implement our business plan and pursue and achieve these goals. After giving effect to the funds received in past equity and debt financings and assuming our use of that funding at the rate we presently believe that, as of May 1, 2024, our current cash on hand will meet our anticipated cash requirements into the third quarter of fiscal 2024.

 

Manufacturing

 

We work with contract manufacturing and related organizations, including those operating under cGMP, as is required by applicable regulatory agencies for production of product that can be used for preclinical and human testing as well as for commercial use. We also have engaged and continue to engage other third parties in the United States and abroad to advise on and perform certain manufacturing and related activities, typically with assistance from our team. The activities include development of our primary product candidates, as well as generation of appropriate analytical methods, scale-up, and other procedures for use by manufacturers and/or other members of our supply chain to produce or process our products at current and/or larger scale quantities for research, development, and commercialization.

 

6

 

 

Our products are regulated as medical devices, and as such, many of our activities have focused on optimizing traditional parameters to target specifications, biocompatibility, physical appearance, stability, and handling characteristics, among other metrics, to achieve the desired product. We and our partners intend to continue to monitor manufacturing processes and formulation methods closely, as success or failure in establishing and maintaining appropriate specifications may directly impact our ability to conduct additional preclinical and clinical trials and/or deliver commercial product.

 

We believe that the manufacturing methods used for a product, including the type and source of ingredients and the burden of waste byproduct elimination, are important determinants of its opportunity for profitability. Industry participants are keenly aware of the downsides of products that rely on expensive biotechnology techniques and facilities for manufacture, onerous and expensive programs to eliminate complex materials, or ingredients that are sourced from the complicated process of human or other animal plasma separation, since those products typically are expensive, burdensome to produce, and at greater risk for failing regulatory oversight.

 

The manufacturing methods that we use to produce our current products rely on detailed, complex and difficult to manage synthetic organic chemistry processes. Although use of those methods requires that we engage manufacturers that possess the expertise, skill and know-how involved with those methods, the required equipment to use those methods is widely available. Our current products are synthesized from naturally occurring ingredients amino acids that, while not sourced from humans or other animals, do exist in their natural state in humans. That type of ingredient may be more likely to be categorized as “generally recognized as safe”, or “GRAS”, by the FDA.

 

Recent Developments

 

On January 5, 2024, the Company entered into an amendment (“Amendment No. 14 to the First Notes”) with the holders of the Company’s outstanding 2022 Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, and November 15, 2023 issued in connection with the First Closing. On January 5, 2024, the Company also entered into an amendment (“Amendment No. 14 to the Second Notes”) with the holders of the Company’s outstanding Second Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, and November 15, 2023 issued in connection with the Second Closing. On January 5, 2024, the Company also entered into an amendment (“Amendment No. 9 to the Third Notes” and, together with Amendment No. 14 to the First Notes and Amendment No. 14 to the Second Notes, the “Amendments to the 2022 Notes”) with the holders of the Company’s outstanding Third Notes, as amended on June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, and November 15, 2023 issued in connection with the Third Closing. Under the Amendments to the 2022 Notes, the Second Notes and the Third Notes were amended to extend the date of the completion of an uplist to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange, or NYSE American (such transaction, an “Uplist Transaction”) and to extend the respective maturity date of each of the 2022 Notes from January 6, 2024, to March 15, 2024.

 

As a result of the entry into the Amendments to the 2022 Notes, and pursuant to the terms of the Company’s outstanding Exchanged Notes, the Exchanged Notes were automatically amended to extend the date of completion of an Uplist Transaction from January 6, 2024, to March 15, 2024.

 

On March 12, 2024, the Company entered into Amendment No. 3 to the SPA (the “Third Amendment”) with certain Investors in connection with the fourth closing of the Convertible Notes Offering for the issuance and sale by the Company to such Investors of an aggregate of (i) Unsecured Convertible Promissory Notes (the “Fourth Notes”) in the aggregate principal amount of $648,000, which includes an aggregate $108,000 original issue discount in respect of the Fourth Notes; (ii) Warrants (the “Fourth Warrants”) to purchase an aggregate of 130,383 shares (the “Warrant Shares”) of Common Stock; and (iii) 9,779 shares of Common Stock (the “Inducement Shares”). The aggregate net proceeds for the sale of the Fourth Notes, Fourth Warrants and Inducement Shares was approximately $450,000, after deducting issuance discounts. The fourth closing of the sales of these securities under the Amended SPA occurred on March 12, 2024 (the “Fourth Closing Date”). On March 18, 2024, effective March 15, 2024, the Company entered into Amendment No. 1 to the Fourth Notes, as described in detail below, to modify the terms of the Uplist Transaction (as defined below) repayment provision and extend the date for completion of the Uplist Transaction. In connection with the issuance of the Fourth Notes and in lieu of issuing 9,779 Inducement Shares, the Company issued the investor 9,782 pre-funded warrants with an exercise price of $0.001 per share.

 

The Company intends to use the net proceeds from the Convertible Notes Offering primarily for working capital and general corporate purposes, and has not allocated specific amounts for any specific purposes.

 

7

 

 

The Fourth Notes become due and payable on March 15, 2024 and may not be prepaid, in whole or in part, at any time except with the written consent of the lead investor, with such prepayment amounts subject to adjustment as a result of certain time-based prepayment premiums set forth in the Fourth Notes; provided, that, the written consent of the lead investor is not required in connection with a prepayment made from the proceeds of an Uplist Transaction (as defined below). The Fourth Notes bear interest on the unpaid principal balance at a rate equal to ten percent (10%) (computed on the basis of the actual number of days elapsed in a 360-day year) per annum accruing from the Fourth Closing Date until the Fourth Notes become due and payable at maturity or upon their conversion, acceleration or by prepayment, and may become due and payable upon the occurrence of an event of default under the Fourth Notes. Any amount of principal or interest on the Fourth Notes which is not paid when due shall bear interest at the rate of the lesser of (i) eighteen percent (18%) per annum or (ii) the maximum amount allowed by law from the due date thereof until payment in full.

 

The Fourth Notes are convertible into an aggregate of 65,191 shares of Common Stock at the option of each holder of the Fourth Notes from the Fourth Closing Date at the Conversion Price through the later of (i) the Maturity Date and (ii) the date of payment of the Default Amount (as defined in the Fourth Note); provided, however, certain Fourth Notes include a provision preventing such conversion if, as a result, the holder, together with its affiliates and any other persons whose beneficial ownership of Company Common Stock would be aggregated with the holder’s, would be deemed to beneficially own more than 4.99% of the outstanding shares of the Company’s Common Stock immediately after giving effect to the Conversion; and provided further, the holder, upon notice to the Company, may increase or decrease the Notes Ownership Limitation; provided that (i) the Notes Ownership Limitation may only be increased to a maximum of 9.99% of the outstanding shares of the Company’s Common Stock; and (ii) any increase in the Notes Ownership Limitation will not become effective until the 61st day after delivery of such waiver notice. The initial conversion price of the Fourth Notes (the “Conversion Price”) shall be equal to $9.14 and may be reduced or increased proportionately as a result of any stock dividends, recapitalizations, reorganizations, and similar transactions. If the Company fails to deliver the shares of Common Stock issuable upon a conversion by the Deadline (as defined in the Fourth Notes), then the Company is obligated to pay such Fourth Note holder $5,000 per day in cash for each day beyond the Deadline. The Fourth Warrants (i) have an exercise price of $9.94 per share; (ii) have a term of exercise equal to 5 years after their issuance date; (iii) are exercisable immediately after their issuance; and (iv) have a provision preventing the exercisability of such Fourth Warrant if, as a result of the exercise of the Fourth Warrant, the holder, together with its affiliates and any other persons whose beneficial ownership of Company Common Stock would be aggregated with the holder’s, would be deemed to beneficially own more than either 4.99% or 9.99% of the outstanding shares of the Company’s Common Stock (the “Warrant Ownership Limitation”) immediately after giving effect to the exercise of the Fourth Warrant. The holder, upon notice to the Company, may increase or decrease the Warrant Ownership Limitation; provided that (i) the Warrant Ownership Limitation may only be increased to a maximum of 9.99% of the outstanding shares of the Company’s Common Stock; and (ii) any increase in the Warrant Ownership Limitation will not become effective until the 61st day after delivery of such waiver notice. The number of shares of Common Stock into which each of the Fourth Warrants is exercisable and the exercise price therefor are subject to adjustment as set forth in the Fourth Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise).

 

On March 12, 2024, we entered into an amendment (the “Third A&R Registration Rights Agreement”) to that certain Second Amended and Restated Registration Rights Agreement, dated as of May 15, 2023, by and among us and certain institutional and accredited individual investors, as amended (the “A&R Registration Rights Agreement”). Under the Third A&R Registration Rights Agreement, the A&R Registration Rights Agreement was amended to obligate us to file with the SEC a registration statement covering the resale of the securities issued on the Fourth Closing Date.

 

On March 18, 2024, with effectiveness as of March 15, 2024, the Company entered into an amendment (“Amendment No. 15 to the First Notes”) with the holders of the Company’s outstanding Senior Secured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023 and January 5, 2024 (as amended, the “First Notes”), issued in connection with a private placement financing the Company completed on July 6, 2022. On March 18, 2024, with effectiveness as of March 15, 2024, the Company also entered into an amendment (“Amendment No. 15 to the Second Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023 and January 5, 2024 (as amended, the “Second Notes”), issued in connection with a private placement financing the Company completed on January 18, 2023. On March 18, 2024, with effectiveness as of March 15, 2024, the Company also entered into an amendment (“Amendment No. 10 to the Third Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023 and January 5, 2024 (as amended, the “Third Notes”), issued in connection with a private placement financing the Company completed on May 15, 2023. On March 18, 2024, with effectiveness as of March 15, 2024, the Company also entered into an amendment (“Amendment No. 1 to the Fourth Notes”) with the holders of the Company’s outstanding Senior Secured Convertible Promissory Notes, issued in connection with a private placement financing the Company completed on March 12, 2024 (as amended, the “Fourth Notes” and, together with the First Notes, Second Notes, and Third Notes, the “Notes”).

 

8

 

 

Under the amendments to the Notes, the following amendments will be simultaneously effective upon the closing of the Uplist Transaction. 95% of the then outstanding principal amount of the Notes shall automatically convert (the “Automatic Conversion”) into shares of Common Stock, with the conversion price for purposes of such Automatic Conversion being $0.50 (or $4.00 giving effect to the anticipated reverse stock split). Upon the Automatic Conversion and to the extent that the beneficial ownership of a holder of Notes (a “Holder” and, all holders of Notes together, the “Holders”) would increase over the applicable Notes Ownership Limitation, the Holder will receive pre-funded warrants (the “Note Conversion Pre-Funded Warrants”, and the shares issuable upon exercise thereof, the “Note Conversion Pre-Funded Warrant Shares”) in lieu of shares of Common Stock otherwise issuable to the Holder in connection with the Automatic Conversion, which Note Conversion Pre-Funded Warrants shall have an exercise price of $0.000125 per share (or $0.001 giving effect to the anticipated reverse stock split), may be exercised on a cashless basis, shall be exercisable immediately upon issuance and shall contain a customary beneficial ownership limitation provision. Additionally, under the amendments to the Notes, the Uplist Transaction completion date and the Maturity Date (as defined in the Notes) were modified to April 30, 2024.

 

In addition, upon the Automatic Conversion, the Holder shall receive a warrant (the “Uplist Conversion Warrant”, and the shares issuable upon exercise thereof, to purchase a number of shares of Common Stock equal to 80 (or 10 giving effect to the anticipated reverse stock split) times the dollar amount under the Notes that was converted in the Automatic Conversion. The Uplist Conversion Warrant shall have an exercise price per share of $0.50 (or $4.00 giving effect to the anticipated reverse stock split) and shall otherwise be identical to the warrants being issued to the investors under the Purchase Agreement dated November 8, 2023.

 

On March 28, 2024, certain purchaser parties (the “Advancing Purchasers”) to the previously disclosed Securities Purchase Agreement (the “SPA”) dated November 8, 2023, among Arch Therapeutics, Inc. (the “Company”) and the purchasers party thereto, advanced the Company an aggregate of $250,000 (the “Advance”), which Advance is being treated as partial prepayment of the purchase price for the Advancing Purchasers under the SPA.

 

The Advance included the following terms: (i) if the Closing (as defined in the SPA) does not occur on or before April 30, 2024, the Advancing Purchasers shall have the option, in lieu of being repaid the Advance, to purchase (A) pre-funded warrants to purchase up to an aggregate of 484,963 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”) (using the SPA pre-funded warrant purchase price of $0.5155 per pre-funded warrant) and (B) common warrants to purchase up to an aggregate of 484,963 shares of Common Stock (using the 100% warrant coverage provided in the SPA), in satisfaction of the Company’s obligation to repay the Advance to the Advancing Purchasers and (ii) if the Common Stock has not been approved by Nasdaq for listing on Nasdaq Capital Market by April 30, 2024, then by no later than May 2, 2024, the Company shall issue to the Advancing Purchasers (A) additional prefunded warrants to purchase up to an aggregate of 121,240 shares of Common Stock (which represents a 25% addition) and (B) additional common warrants to purchase up to an aggregate of 121,240 shares of Common Stock.

 

On April 30, 2024, the Company entered into an amendment (“Amendment No. 1 to the Third A&R Registration Rights Agreement”) to that certain Third Amended and Restated Registration Rights Agreement, dated as of March 12, 2024, by and among us and certain institutional and accredited individual investors, as amended (the “A&R Registration Rights Agreement”). Under Amendment No. 1 to the Third A&R Registration Rights Agreement, the A&R Registration Rights Agreement was amended to redefine “Uplist Transaction” as the listing of the Company’s common stock, par value $0.001 (“Common Stock”), on any securities exchange registered with the U.S. Securities and Exchange Commission (“SEC”) as a “national securities exchange” under Section 6 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

 

On May 1, 2024, the Company entered into an amendment (“Amendment No. 4 to the Bridge Registration Rights Agreement”) to that certain Registration Rights Agreement, dated as of July 7, 2023, as amended on August 30, 2023, and as subsequently amended on November 8, 2023 and November 21, 2023, by and among the Company and certain institutional and accredited individual investors (as amended the “Bridge Registration Rights Agreement”) in connection with a private placement offering of pre-funded warrants to purchase shares of Common Stock, common warrants to purchase shares of Common Stock, and shares of Common Stock. Under Amendment No. 4 to the Bridge Registration Rights Agreement, the Bridge Registration Rights Agreement was amended to redefine “Uplist” as the public offering of the Company’s Common Stock pursuant to a registration statement on Form S-1 that results in the listing of the Company’s Common Stock on any securities exchange registered with the SEC as a “national securities exchange” under Section 6 of the Exchange Act.

 

On April 30, 2024, the Company entered into an amendment (“Amendment No. 16 to the First Notes”) with the holders of the Company’s outstanding Senior Secured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024 and March 15, 2024 (as amended, the “First Notes”), issued in connection with a private placement financing the Company completed on July 6, 2022.

 

On April 30, 2024, the Company also entered into an amendment (“Amendment No. 16 to the Second Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024 and March 15, 2024 (as amended, the “Second Notes”), issued in connection with a private placement financing the Company completed on January 18, 2023.

 

9

 

 

On April 30, 2024, the Company also entered into an amendment (“Amendment No. 11 to the Third Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024 and March 15, 2024 (as amended, the “Third Notes”), issued in connection with a private placement financing the Company completed on May 15, 2023.

 

On April 30, 2024, the Company also entered into an amendment (“Amendment No. 2 to the Fourth Notes” and, together with Amendment No. 16 to the First Notes, Amendment No. 16 to the Second Notes and Amendment No. 11 to the Third Notes, the “Amendments to the Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on March 15, 2024, issued in connection with a private placement financing the Company completed on March 12, 2024 (as amended, the “Fourth Notes” and, together with the First Notes, Second Notes, and Third Notes, the “Notes”).

 

Under the Amendments to the Notes, the Notes were amended to extend the date of the completion of an “Uplist Transaction” (as defined below) and to extend the respective maturity date of each of the Notes from April 30, 2024, to June 30, 2024. The Notes were also amended to redefine “Uplist Transaction” as the listing of the Company’s Common Stock on any securities exchange registered with the SEC as a “national securities exchange” under Section 6 of the Exchange Act.

 

The Company entered into a Securities Purchase Agreement, dated May 15, 2024, with certain institutional and accredited individual investors who have previously purchased secured promissory notes from the Company, providing for the issuance and sale by the Company to the Investors certain Secured Promissory Notes (each a “2024 First Note” and collectively, the “2024 First Notes”) convertible into shares of common stock, par value $0.001 per share. The 2024 First Notes were issued as part of a convertible notes offering authorized by the Company’s board of directors.

 

In connection with the Convertible Notes Offering, the Company issued and sold to the Investors the 2024 First Notes in the aggregate principal amount of $2,220,000, which includes an aggregate $370,000 original issue discount in respect of the 2024 First Notes. The aggregate net proceeds for the sale of the 2024 First Notes was approximately $1,850,000, after deducting issuance discounts. The closing of the sales of the 2024 First Notes under the SPA occurred on May 15, 2024 (the “Closing Date”).

 

On June 18, 2024, an additional investor, which is not a PIPE Investor, purchased 2024 Notes on June 12, 2024 in the principal amount of $180,000, including an original issue discount of $30,000. The 2024 Notes were issued as part of a convertible notes offering authorized by the Company’s board of directors (the “2024 Notes Financing”).

 

On June 19, 2024, certain of the PIPE Investors (as defined below) (the “Backstop Buyers”) agreed that in the event that as of the close of business on the date that is 10 calendar days prior to the date Arch Therapeutics, Inc. (the “Company”) reasonably expects the closing of the Uplist PIPE (as defined below) to occur (the “Escrow Date”) there is not an amount of funds in escrow for the Uplist PIPE equal to $5,900,000 less the aggregate purchase price paid for the 2024 Notes (as defined below) (such circumstance, an “Escrow Deficiency”), then each of the Backstop Buyers will deposit in escrow the purchase price for a pro rata share of an amount, no greater than $1,500,000, equal to (A) $320,000 plus (B) (i) $5,900,000, minus (ii) the amount of funds in escrow on the Escrow Date, minus (iii) the aggregate purchase price paid by PIPE Investors for the 2024 Notes ( the “Backstop Amount”) of additional PIPE Pre-Funded Warrants (as defined below) and PIPE Investor Warrants (as defined below) under the PIPE SPA (as defined below) (such agreement, the “Backstop Agreement”), and shall purchase such additional PIPE Pre-Funded Warrants and PIPE Investor Warrants at the Uplist PIPE closing. In consideration for the execution by the Backstop Buyers of the Backstop Agreement, the Company agreed to issue to the Backstop Buyers, as soon as practicable, pre-funded warrants (the “Execution Backstop Pre-Funded Warrants”), in form and substance substantially similar to the PIPE Pre-Funded Warrants, to purchase an aggregate of 225,000 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”). The Company also agreed to issue to the Backstop Buyers (i) additional pre-funded warrants (the “Funding Backstop Pre-Funded Warrants” and, together with the Execution Backstop Pre-Funded Warrants, the “Backstop Pre-Funded Warrants”) to purchase an amount of shares of Common Stock equal to 0.5 shares per dollar of funding deposited under the Backstop Agreement, or up to an aggregate of 750,000 shares, and (ii) investor warrants (the “Backstop Common Warrants”), in form and substance substantially similar to the PIPE Investor Warrants, to purchase an amount of shares of Common Stock equal to 0.65 shares per dollar of funding deposited under the Backstop Agreement, or up to an aggregate of 975,000 shares. The resale prospectus (the “Resale Prospectus”) in the registration statement on Form S-1, filed by the Company with the Securities and Exchange Commission (the “SEC”) on October 26, 2022, as subsequently amended (the “Registration Statement”), currently covers the resale of the shares of Common Stock underlying the Backstop Pre-Funded Warrants and the Backstop Common Warrants. The Resale Prospectus assumes that no Escrow Deficiency will occur and thus no funding will be deposited under the Backstop Agreement and no Funding Backstop Pre-Funded Warrants or Backstop Common Warrants will be issued.

 

On June 26, 2024, the Company consummated a third closing (the “Third Closing”) of the Convertible Notes Offering pursuant to the terms and conditions of the SPA with the Investor providing for the issuance and sale by the Company to the Investor an additional 2024 First Note convertible into shares of Common Stock. The 2024 First Note was issued as part of the Convertible Notes Offering previously authorized by the Company’s board of directors. In connection with the Third Closing of the Convertible Notes Offering, the Company issued and sold to the Investor a 2024 First Note in the principal amount of $90,000, which includes a $15,000 original issue discount in respect of the 2024 First Note. The net proceeds for the sale of the 2024 First Note was approximately $75,000, after deducting issuance discounts. The Third Closing of the sale of the 2024 First Note under the SPA occurred on June 26, 2024 (the “Third Closing Date”).

 

10

 

 

On June 30, 2024, the Company entered into an amendment (“Amendment No. 17 to the First 2022 Notes”) with the holders of the Company’s outstanding Senior Secured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024, March 15, 2024 and April 30, 2024 (as amended, the “First 2022 Notes”), issued in connection with a private placement financing the Company completed on July 6, 2022.

 

On June 30, 2024, the Company also entered into an amendment (“Amendment No. 17 to the Second 2022 Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on February 14, 2023, March 10, 2023, March 15, 2023, April 15, 2023, May 15, 2023, June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024, March 15, 2024 and April 30, 2024 (as amended, the “Second 2022 Notes”), issued in connection with a private placement financing the Company completed on January 18, 2023.

 

On June 30, 2024, the Company also entered into an amendment (“Amendment No. 12 to the Third 2022 Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on June 15, 2023, July 1, 2023, July 7, 2023, July 31, 2023, August 30, 2023, September 30, 2023, October 31, 2023, November 15, 2023, January 5, 2024, March 15, 2024 and April 30, 2024 (as amended, the “Third 2022 Notes”), issued in connection with a private placement financing the Company completed on May 15, 2023.

 

On June 30, 2024, the Company also entered into an amendment (“Amendment No. 3 to the Fourth 2022 Notes”) with the holders of the Company’s outstanding Unsecured Convertible Promissory Notes, as separately amended on March 15, 2024 and April 30, 2024, issued in connection with a private placement financing the Company completed on March 12, 2024 (as amended, the “Fourth 2022 Notes”).

 

On June 30, 2024, the Company also entered into an amendment (“Amendment No. 1 to the First 2024 Notes” and, together with Amendment No. 17 to the First 2022 Notes, Amendment No. 17 to the Second 2022 Notes, Amendment No. 12 to the Third 2022 Notes and Amendment No. 3 to the Fourth 2022 Notes, the “Amendments to the Notes”) with the holders of the Company’s outstanding Senior Secured Convertible Promissory Notes issued in connection with a private placement financing the Company completed on May 15, 2024 (as amended, the “First 2024 Notes” and, together with the First 2022 Notes, Second 2022 Notes, Third 2022 Notes and Fourth 2022 Notes, the “Notes”).

 

On July 16, 2024, the Company consummated a fourth closing (the “Fourth Closing”) of the Convertible Notes Offering pursuant to the terms and conditions of the SPA with certain institutional and accredited individual investors who have previously purchased secured promissory notes from the Company (the “Investors”), providing for the issuance and sale by the Company to the Investors 2024 First Notes convertible into shares of Common Stock. The 2024 First Notes were issued as part of the Convertible Notes Offering previously authorized by the Company’s board of directors. In connection with the Fourth Closing of the Convertible Notes Offering, the Company issued and sold to the Investors 2024 First Notes in the aggregate principal amount of $168,000, which includes an aggregate $28,000 original issue discount in respect of the 2024 First Notes. The net proceeds for the sale of the 2024 First Notes was approximately $140,000, after deducting issuance discounts. The Fourth Closing of the sale of the 2024 First Notes under the SPA occurred on July 16, 2024 (the “Fourth Closing Date”).

 

Upon the closing of the transaction that results in the uplist of the Common Stock to a National Exchange, 100% of the then outstanding principal amount of the 2024 First Notes shall automatically convert (the “Automatic Conversion”) into shares of Common Stock (the “Automatic Conversion Shares”), with the conversion price for purposes of such Automatic Conversion being $0.515625 per share. Upon the Automatic Conversion and to the extent that the beneficial ownership of the Holders of 2024 First Notes would increase over the applicable Note Ownership Limitation, the Holder will receive pre-funded warrants (the “2024 Note Conversion Pre-Funded Warrants”, and the shares issuable upon exercise thereof, the “2024 Note Conversion Pre-Funded Warrant Shares”) in lieu of shares of Common Stock otherwise issuable to the Holder in connection with the Automatic Conversion, which 2024 Note Conversion Pre-Funded Warrants shall have an exercise price of $0.000125 per share, may be exercised on a cashless basis, shall be exercisable immediately upon issuance and shall contain a customary beneficial ownership limitation provision.

 

In addition, upon the Automatic Conversion, the Holder shall receive a warrant (the “Uplist Conversion Warrant”, and the shares issuable upon exercise thereof, the “Uplist Conversion Warrant Shares”) to purchase a number of shares of Common Stock equal to the number of shares of Common Stock (or shares of Common Stock underlying 2024 Note Conversion Pre-Funded Warrants, if any) issued upon the Automatic Conversion. The Uplist Conversion Warrant shall have an exercise price per share of $0.50 and shall otherwise be identical to the warrants (other than pre-funded warrants) sold pursuant to the securities purchase agreement dated November 8, 2023, as amended. The Company also agreed in the 2024 First Notes to file no later than 60 days after the closing of an uplist to a National Exchange a registration statement on Form S-4, or other appropriate form, registering the offer by the Company to exchange, on a one-for-one basis, all outstanding Uplist Conversion Warrants and certain other warrants for newly issued warrants identical to the warrants being sold in the offering that results in the uplist to a National Exchange, which warrants are expected to be listed on the Cboe BZX Exchange, Inc. under the symbol “ARTHW.”

 

11

 

 

The 2024 First Notes issued on the Fourth Closing will be senior in priority to the 2024 First Notes previously issued on the First Closing, Second Closing, and Third Closing, and the notes previously issued pursuant to the Securities Purchase Agreement, dated as of July 6, 2022, by and among the Company and each of the parties listed on the signature pages thereto.

 

Results of Operations

 

The following discussion of our results of operations should be read together with the unaudited interim condensed consolidated financial statements included in this Report. The period-to-period comparisons of our interim results of operations that follow are not necessarily indicative of future results.

 

Three Months Ended June 30, 2024 Compared to Three Months Ended June 30, 2023

 

   June 30,   June 30,   Increase (Decrease) 
   2024   2023   $ 
Revenue  $30,913   $13,293   $17,620 
Operating expenses:               
Cost of revenues   21,079    18,529    2,550 
Selling, general and administrative   875,629    870,053    5,576 
Research and development   155,681    139,048    16,633 
Loss from operations   (1,021,476)   (1,014,337)   (7,139)
Other Expense, net    (4,633,205)   (808,770)   (3,824,435)
Net loss  $(5,654,681)  $(1,823,107)  $(3,831,574)

 

Revenue

 

Revenue for the three months ended June 30, 2024 was $30,913, an increase of $17,620 compared to revenue of $13,293 for the three months ended June 30, 2023. The increase in revenues during the three months ended June 30, 2024, was primarily the result of transactions leveraging the dedicated HCPCS code (A2020) that went effective April 1, 2023 through a growing number of providers and offices working with the Company to submit reimbursement claims with numerous payors, as well as transactions into a single hospital. Revenue for the three months ended June 30, 2023 was the result of transactions into VA Hospitals through our distribution partner, Lovell Government Services (“LGS”), as well as transactions into a single hospital.

 

Cost of Revenues

 

Cost of revenue for the three months ended June 30, 2024 was $21,079, an increase of $2,550 compared to cost of revenue of $18,529 for the three months ended June 30, 2023. The increase in cost of revenue corresponds with the increase in revenues and includes product costs, third party warehousing, overhead allocation, royalty and shipping costs.

 

Selling, General and Administrative Expense

 

Selling, general and administrative expense for the three months ended June 30, 2024 was $875,629, an increase of $5,576 compared to $870,053 for the three months ended June 30, 2023. The increase in selling, general and administrative expense for the three months ended June 30, 2024 is primarily due to an increase in legal expenses and marketing costs, partially offset by a decrease in payroll costs.

 

Research and Development Expense

 

Research and development expense for the three months ended June 30, 2024 was $155,681, an increase of $16,633, compared to $139,048 for the three months ended June 30, 2023. The increase in research and development expenses is primarily attributable to an increase in payroll and employee benefits, partially offset by a decrease in research consultants and advisor’s expense.

 

Other (Expense) Income

 

Other expense during the three months ended June 30, 2024 was $4,633,205, a increase of $3,824,435, compared to other expense of $808,770 for the three months ended June 30, 2023. The increase in other expense is primarily attributable to an increase in financing expense related to warrant issuances totaling $3,961,276, recognition of OID for 2021 First Notes transactions and increase in interest expense due to increase in aggregated outstanding principal of the debt and partially offset by decrease in accreditation of discount and issuance costs related to the 2022 Notes, Second Notes and Third Notes.

 

12

 

 

Nine Months Ended June 30, 2024 Compared to Nine Months Ended June 30, 2023

 

   June 30,   June 30,   Increase (Decrease) 
   2024   2023   $ 
Revenue  $108,646   $36,207   $72,439 
Operating expenses:               
Cost of revenues   66,240    54,882    11,358 
Selling, general and administrative   2,870,163    3,225,753    (355,590)
Research and development   565,130    471,135    93,995 
Loss from operations   (3,392,887)   (3,715,563)   322,676 
Other Expense, net   (6,412,585)   (810,077)   (5,602,508)
Net loss  $(9,805,472)  $(4,525,640)  $(5,279,832)

 

Revenue

 

Revenue for the nine months ended June 30, 2024 was $108,646, an increase of $72,439 compared to revenue of $36,207 for the nine months ended June 30, 2023. Revenue for the nine months ended June 30, 2024 was the result of several transactions into a single hospital, transactions into VA Hospitals through LGS, and transactions leveraging the dedicated HCPCS code (A2020) that went effective April 1, 2023 through a growing number of providers and offices working with the Company to submit reimbursement claims with numerous payors.

 

Cost of Revenues

 

Cost of revenue during the nine months ended June 30, 2024 was $66,240, an increase of $11,358, compared to cost of revenue of $54,882 for the nine months ended June 30, 2023. The increase in cost of revenues corresponds to the increase in revenues. Cost of revenue includes product costs, third party warehousing, overhead allocation, royalty and shipping costs. An increase in revenue for the nine months ended June 30, 2024 led to higher cost of revenues as a result.

 

Selling, General and Administrative Expense

 

Selling, general and administrative expense during the nine months ended June 30, 2024 was $2,870,163, a decrease of $355,590 compared to $3,225,753 for the nine months ended June 30, 2023. The decrease in selling, general and administrative expense for the nine months ended June 30, 2024 is primarily due to a decrease in payroll costs and stock-based compensation, partially offset by an increase in professional fees.

 

Research and Development Expense

 

Research and development expense during the nine months ended June 30, 2024 was $565,130, an increase of $93,995 compared to $471,135 for the nine months ended June 30, 2023. The increase in research and development expense is primarily attributable to an increase in payroll costs partially offset by a decrease in R&D consultants, stock-based compensation, and product purchases.

 

Other (Expense) Income

 

Other expense during the nine months ended June 30, 2024 was $6,412,585, an increase of $5,602,508 compared to other expense of $810,077 for the nine months ended June 30, 2023. The increase in other expense is primarily attributed to an increase in financing expense related to warrant issuances totaling $3,961,276, increase in interest expense related to the amortization of debt discount and debt issuance costs for 2022 Notes, Second Notes, Third, and Fourth Notes as well as increase in related OID discount recognized for 2024 First Notes and overall increase in interest expense due to increase in aggregated outstanding principal of the debt. Additionally, the increase in other expense is primarily attributable to the gain on extinguishment of derivative liabilities that was recognized during the nine months ended June 30, 2023 of approximately $1,200,000 income and did not occur during the nine months ended June 30, 2024.

 

Liquidity and Capital Resources

 

In the first calendar quarter of 2021, the Company commenced commercial sales of our first product, AC5® Advanced Wound System. We devote a significant amount of our efforts on fundraising as well as planning and conducting product research and development and activities in connection with obtaining regulatory marketing authorization. We have principally raised capital through the issuance of convertible debt and units consisting of Common Stock and warrants to fund our operations.

 

13

 

 

Working Capital

 

At June 30, 2024, we had total current assets of $1,391,130 (including cash of $30,030) and a working capital deficit of $12,567,080. Our working capital as of June 30, 2024 and September 30, 2023 are summarized as follows:

 

   June 30,   September 30, 
   2024   2023 
Total Current Assets  $1,391,130   $1,950,090 
Total Current Liabilities   13,958,210    9,465,921 
Working Capital Deficit  $(12,567,080)  $(7,515,831)

 

Total current assets as of June 30, 2024 were $1,391,130, a decrease of $558,960, compared to $1,950,090, as of September 30, 2023. The decrease in current assets is primarily attributable to a decrease in cash and prepaid expenses. Our total current assets as of June 30, 2024 and September 30, 2023 were comprised primarily of cash, inventory and prepaid expenses and other current assets.

 

Total current liabilities as of June 30, 2024 were $12,567,080, an increase of $4,492,289, compared to $9,465,921 as of September 30, 2023. The increase is primarily due to an increase in shareholder advances and accounts payable, new notes issued during the period, and amortization of the debt discount and debt issuance costs for the notes partially offset by a decrease to the amount owed in connection with the financing of certain insurance premiums and the conversion of the Series 2 and certain Senior Secured convertible note into shares.

 

Cash Flow for the Nine Months Ended June 30, 2024 Compared to the Nine Months Ended June 30, 2023

 

   June 30,   June 30, 
   2024   2023 
Cash Used in Operating Activities  $(2,474,405)  $(2,147,480)
Cash Provided by Financing Activities   2,281,715    1,487,082 
Net decrease in Cash  $(192,690)  $(660,398)

 

Cash Used in Operating Activities

 

Cash used in operating activities increased by $326,925 to $2,474,405 during the nine months ended June 30, 2024, compared to $2,147,480 during the nine months ended June 30, 2023. The increase in cash used in operating activities is primarily attributable to an increase in net loss partially offset by an increase in non-cash accretion of debt discounts and financing costs on warrants issued during the nine months ended June 30, 2024.

 

Cash Provided by Financing Activities

 

Cash provided by financing activities increased by $794,633 to $2,281,715 during the nine months ended June 30, 2024, compared to $1,487,082 cash used in financing activities during the nine months ended June 30, 2023. For the nine months ended June 30, 2024, the increase in cash provided by financing activities was attributable to an increase in proceeds from senior secured and unsecured convertible notes.

 

Cash Requirements

 

We anticipate that our operating expenses, interest expense and other expenses will increase significantly as we continue to implement our business plan and pursue our operational goals. Depending upon additional input from EU and US regulatory authorities, however, we do not expect to generate sufficient revenues from operations before we will need to raise additional capital. Further, our estimates regarding our use of cash could change if we encounter unanticipated difficulties or other issues arise, including without limitation those set forth under the heading “RISK FACTORS” described in our Annual Report, in which case our current funds may not be sufficient to operate our business for the period we expect.

 

In the first quarter of 2021, the Company commenced commercial sales of our first product, AC5® Advanced Wound System. That revenue will not be sufficient to fund our business operations and we will need to obtain additional funding from external sources for the foreseeable future. We do not have any commitments for future capital. Significant additional financing will be required to fund our planned operations in the near term and in future periods, including research and development activities relating to our potential new product candidates, seeking regulatory approval of any other product candidates we may choose to develop, commercializing any product candidates for which we are able to obtain regulatory approval or certification, seeking to license or acquire new assets or businesses, and maintaining our intellectual property rights and pursuing rights to new technologies. We may not be able to obtain additional financing on commercially reasonable or acceptable terms when needed, or at all. We are bound by certain contractual terms and obligations that may limit or otherwise impact our ability to raise additional funding in the near-term including, but not limited to, provisions in the 2022 SPA and 2023 SPA restricting our ability to effect or enter into an agreement to effect any issuance by the Company or any of its subsidiaries of Common Stock or securities convertible, exercisable or exchangeable for Common Stock (or a combination of units thereof) involving a Variable Rate Transaction. These restrictions and provisions could make it more challenging for us to raise capital through the incurrence of debt or through equity issuances. If we cannot raise the money that we need in order to continue to develop our business, we will be forced to delay, scale back or eliminate some or all of our proposed operations. If any of these were to occur, there is a substantial risk that our business would fail, and our stockholders could lose all of their investments.

 

14

 

 

As previously noted, since inception we have funded our operations primarily through equity and debt financings and we expect to continue to seek to do so in the future. If we obtain additional financing by issuing equity securities, our existing stockholders’ ownership will be diluted. Additionally, the terms of securities we may issue in future capital-raising transactions may be more favorable for our new investors, and in particular may include preferences, superior voting rights and the issuance of warrants or other derivative securities, which may have additional dilutive effects. If we obtain additional financing by incurring debt, we may become subject to significant limitations and restrictions on our operations pursuant to the terms of any loan or credit agreement governing the debt. Further, obtaining any loan, assuming a loan would be available when needed on acceptable terms, would increase our liabilities and future cash commitments. We may also seek funding from collaboration or licensing arrangements in the future, which may require that we relinquish potentially valuable rights to our product candidates or proprietary technologies or grant licenses on terms that are not favorable to us. Moreover, regardless of the manner in which we seek to raise capital, we may incur substantial costs in those pursuits, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other related costs.

 

Going Concern

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. As reflected in the accompanying condensed financial statements, for the nine months ended June 30, 2024, the Company recorded a net loss of $9,805,472 and used cash in operations of $2,474,405. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s September 30, 2023, financial statements, raised substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Pursuant to certain disclosure guidance issued by the SEC, the SEC defines “critical accounting policies” as those that require the application of management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Our critical accounting policies that we anticipate will require the application of our most difficult, subjective, or complex judgments are as follows:

 

Use of Estimates

 

Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expense during the reporting periods. Significant estimates include the assumptions used in the accrual for potential liabilities, the net realizable value of inventory, the valuation of debt and equity instruments, the fair value of derivative liabilities, valuation of equity instruments issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

 

Accounting for Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”), which requires all share-based payments be recognized in the condensed consolidated financial statements based on their fair values. In accordance with ASC 718, the Company has elected to use the Black-Scholes Option Pricing Model (the “Black-Scholes Model”) to determine the fair value of options granted and recognizes the compensation cost of share-based awards on a straight-line basis over the vesting period of the award.

 

Off-Balance Sheet Arrangements

 

We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed by, or under the supervision of, the Principal Executive Officer and Principal Financial Officer and effected by our Board of Directors, management and other personnel, 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. Under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal ControlIntegrated Framework issued in 2013 by the Committee of Sponsoring Organizations (“COSO”). As of June 30, 2024, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective.

 

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

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal controls over financial reporting that occurred during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting. From time to time, we make changes to our internal control over financial reporting that are intended to enhance its effectiveness, and which do not have a material effect on our overall internal control over financial reporting.

 

15

 

 

PART II OTHER INFORMATION

 

Item 1. Legal Proceedings

 

In the ordinary course of business, we may become a party to legal proceedings involving various matters. We are unaware of any such legal proceedings presently pending to which we or our subsidiary is a party or of which any of our property is the subject that management deems to be, individually or in the aggregate, material to our financial condition or results of operations.

 

Item 1A. Risk Factors

 

In addition to the other information set forth in this Report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” of our Annual Report, which could materially affect our business, financial condition or future results. The risks described in our Annual Report may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.

 

There were no material changes to the risk factors previously disclosed in our Annual Report.

 

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

 

Not applicable

 

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

Not applicable

 

16

 

 

Item 6. Exhibits

 

            Incorporated by Reference

Exhibit

No.

  Exhibit Title  

Filed

Herewith

  Form  

Exhibit

No.

  File No.  

Filing

Date

                         
10.1   Form of Amendment No. 1 to Third A&R Registration Rights Agreement       8-K   10.1   000-54986   5/6/24
10.2   Form of Amendment No. 4 to Registration Rights Agreement       8-K   10.2   000-54986   5/6/24
10.3   Form of Amendment No. 16 to the First Notes       8-K   10.3   000-54986   5/6/24
10.4   Form of Amendment No. 16 to the Second Notes       8-K   10.4   000-54986   5/6/24
10.5   Form of Amendment No. 11 to the Third Notes       8-K   10.5   000-54986   5/6/24
10.6   Form of Amendment No. 2 to the Fourth Notes       8-K   10.6   000-54986   5/6/24
10.7   Form of Securities Purchase Agreement       8-K   10.1   000-54986   5/21/24
10.8   Form of 2024 First Note       8-K   10.2   000-54986   5/21/24
10.9   Form of Registration Rights Agreement       8-K   10.3   000-54986   5/21/24
10.10   Form of Security Agreement       8-K   10.4   000-54986   5/21/24
10.11   Form of IP Security Agreement       8-K   10.5   000-54986   5/21/24
10.12   Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.1   000-54986   6/18/24
10.13   Form of 2024 First Note (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.2   000-54986   6/18/24
10.14   Form of Registration Rights Agreement (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.3   000-54986   6/18/24
10.15   Form of Security Agreement (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.4   000-54986   6/18/24
10.16   Form of IP Security Agreement (Incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.5   000-54986   6/18/24
10.17   Form of PIPE Pre-Funded Warrant (incorporated by reference to Exhibit 4.7 to the Company’s Registration Statement on Form S-1/A filed on November 9, 2023)       8-K   4.1   000-54986   6/25/24
10.18   Form of PIPE Common Warrant (incorporated by reference to Exhibit 4.8 to the Company’s Registration Statement on Form S-1/A filed on November 9, 2023)       8-K   4.2   000-54986   6/25/24
10.19   Form of Backstop Agreement       8-K   10.1   000-54986   6/25/24
10.20   Form of Amendment No. 1 to the PIPE Securities Purchase Agreement       8-K   10.2   000-54986   6/25/24
10.21   Form of Amendment No. 1 to PIPE Registration Rights Agreement       8-K   10.3   000-54986   6/25/24
10.22   Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.1   000-54986   6/28/24
10.23   Form of 2024 First Note (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.2   000-54986   6/28/24
10.24   Form of Registration Rights Agreement (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.3   000-54986   6/28/24
10.25   Form of Security Agreement (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.4   000-54986   6/28/24
10.26   Form of IP Security Agreement (Incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed on May 21, 2024)       8-K   10.5   000-54986   6/28/24
10.27   Form of Amendment No. 17 to the First 2022 Notes       8-K   10.1   000-54986   7/5/24
10.28   Form of Amendment No. 17 to the Second 2022 Notes       8-K   10.2   000-54986   7/5/24
10.29   Form of Amendment No. 12 to the Third 2022 Notes       8-K   10.3   000-54986   7/5/24
10.30   Form of Amendment No. 3 to the Fourth 2022 Notes       8-K   10.4   000-54986   7/5/24
10.31   Form of Amendment No. 1 to First 2024 Notes       8-K   10.5   000-54986   7/5/24
31.1   Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities and Exchange Act of 1934   X                
31.2   Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities and Exchange Act of 1934   X                
32.1   Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Terrence W. Norchi, President and Chief Executive Officer, and Michael S. Abrams, Chief Financial Officer and Treasurer   X                
                         
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 and included in Exhibit 101)                    

 

* Filed herewith.

 

** Furnished herewith.

 

17

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  ARCH THERAPEUTICS, INC.
   
Date: August 19, 2024 By:  /s/ TERRENCE W. NORCHI, MD
    Terrence W. Norchi, MD
    President and Chief Executive Officer
    (Principal Executive Officer)
     
Date: August 19, 2024 By: /s/ MICHAEL S. ABRAMS
    Michael S. Abrams
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

18

 

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO RULE 13A-14(A) OR 15D-14(A) UNDER THE SECURITIES AND EXCHANGE ACT OF 1934

 

I, Terrence W. Norchi, certify that:

 

1.I have reviewed this Form 10-Q of Arch Therapeutics, 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.

 

  Date: August 19, 2024
   
    /s/ TERRENCE W. NORCHI, MD
  Name:  Terrence W. Norchi, MD
  Title: President and Chief Executive Officer
    (Principal Executive Officer)

 

 

 

 

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO RULE 13A-14(A) OR 15D-14(A) UNDER THE SECURITIES AND EXCHANGE ACT OF 1934

 

I, Michael S. Abrams, certify that:

 

1.I have reviewed this Form 10-Q of Arch Therapeutics, 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.

 

  Date: August 19, 2024
   
    /s/ MICHAEL S. ABRAMS
  Name:  Michael S. Abrams
  Title: Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

 

 

 

Exhibit 32.1

 

CERTIFICATION REQUIRED BY

SECTION 1350 OF TITLE 18 OF THE UNITED STATES CODE

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned officers of Arch Therapeutics, Inc. (the “Company”) certify that the quarterly report of the Company on Form 10-Q for the fiscal quarter ended June 30, 2024 fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  Date: August 19, 2024
   
    /s/ TERRENCE W. NORCHI, MD
  Name: Terrence W. Norchi, MD
  Title: President and Chief Executive Officer
    (Principal Executive Officer)
     
  Date: August 19, 2024
     
    /s/ MICHAEL S. ABRAMS
  Name:  Michael S. Abrams
  Title: Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

This certification accompanies this Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.

 

 

v3.24.2.u1
Cover - shares
9 Months Ended
Jun. 30, 2024
Aug. 19, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2024  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --09-30  
Entity File Number 000-54986  
Entity Registrant Name ARCH THERAPEUTICS, INC.  
Entity Central Index Key 0001537561  
Entity Tax Identification Number 46-0524102  
Entity Incorporation, State or Country Code NV  
Entity Address, Address Line One 235 Walnut Street  
Entity Address, Address Line Two Suite 6  
Entity Address, City or Town Framingham  
Entity Address, State or Province MA  
Entity Address, Postal Zip Code 01702  
City Area Code (617)  
Local Phone Number 431-2313  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   4,444,364
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Current assets:    
Cash $ 30,030 $ 222,720
Inventory 1,320,276 1,364,504
Prepaid expenses and other current assets 40,824 362,866
Total current assets 1,391,130 1,950,090
Long-term assets:    
Property and equipment, net 3,014 4,599
Other assets 3,500 3,500
Total long-term assets 6,514 8,099
Total assets 1,397,644 1,958,189
Current liabilities:    
Accounts payable 2,916,655 2,304,207
Accrued expenses and other liabilities 407,242 467,496
Accrued interest 1,246,092 823,128
Total current liabilities 13,958,210 9,465,921
Commitments and contingencies
Stockholders’ deficit:    
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding as of June 30, 2024 and September 30, 2023
Common stock, $0.001 par value, 350,000,000 authorized as of June 30, 2024 and September 30, 2023; 4,444,364 and 4,689,446 shares issued and outstanding as of June 30, 2024 and September 30, 2023 4,444 4,689
Additional paid-in capital 60,026,073 54,543,188
Accumulated deficit (72,591,083) (62,055,609)
Total stockholders’ deficit (12,560,566) (7,507,732)
Total liabilities and stockholders’ deficit 1,397,644 1,958,189
Insurance Premium Financing [Member]    
Current liabilities:    
Insurance premium financing 243,285
Senior Secured Convertible Notes [Member]    
Current liabilities:    
Convertible notes payable 6,701,720 3,519,103
Unsecured Convertible Notes [Member]    
Current liabilities:    
Convertible notes payable 2,686,501 1,658,702
Convertible Notes Payable Series 2 [Member]    
Current liabilities:    
Convertible notes payable $ 450,000
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Jun. 30, 2024
Sep. 30, 2023
Statement of Financial Position [Abstract]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 5,000,000 5,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 350,000,000 350,000,000
Common stock, shares issued 4,444,364 4,689,446
Common stock, shares outstanding 4,444,364 4,689,446
v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Revenue $ 30,913 $ 13,293 $ 108,646 $ 36,207
Operating expenses:        
Cost of revenues 21,079 18,529 66,240 54,882
Selling, general and administrative expenses 875,629 870,053 2,870,163 3,225,753
Research and development expenses 155,681 139,048 565,130 471,135
Total operating expenses 1,052,389 1,027,630 3,501,533 3,751,770
Loss from operations (1,021,476) (1,014,337) (3,392,887) (3,715,563)
Other (expense) income:        
Interest expense (671,929) (808,770) (2,451,309) (1,968,274)
Financing expense (3,961,276) (3,961,276)
Gain on extinguishment of derivative liabilities 1,158,197
Total other expense, net (4,633,205) (808,770) (6,412,585) (810,077)
Net loss (5,654,681) (1,823,107) (9,805,472) (4,525,640)
Deemed dividends (730,002) (730,002)
Net loss attributable to common shareholders $ (6,384,683) $ (1,823,107) $ (10,535,474) $ (4,525,640)
Net loss per common share, basic $ (1.44) $ (1.42) $ (2.32) $ (3.58)
Net loss per common share, diluted $ (1.44) $ (1.42) $ (2.32) $ (3.58)
Weighted common shares, basic 4,444,364 1,279,967 4,550,264 1,265,340
Weighted common shares, diluted 4,444,364 1,279,967 4,550,264 1,265,340
v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($)
Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Balance at Sep. 30, 2022 $ 1,252 $ 50,878,718 $ (55,072,773) $ (4,192,803)
Balance, shares at Sep. 30, 2022 1,252,734      
Net loss (1,800,056) (1,800,056)
Stock-based compensation expense 104,026 104,026
Balance at Dec. 31, 2022 $ 1,252 50,982,744 (56,872,829) (5,888,833)
Balance, shares at Dec. 31, 2022 1,252,734      
Balance at Sep. 30, 2022 $ 1,252 50,878,718 (55,072,773) (4,192,803)
Balance, shares at Sep. 30, 2022 1,252,734      
Net loss         (4,525,640)
Balance at Jun. 30, 2023 $ 1,285 51,582,100 (59,598,413) (8,015,028)
Balance, shares at Jun. 30, 2023 1,285,209      
Balance at Dec. 31, 2022 $ 1,252 50,982,744 (56,872,829) (5,888,833)
Balance, shares at Dec. 31, 2022 1,252,734      
Net loss (902,477) (902,477)
Stock-based compensation expense 68,524 68,524
Issuance of common stock and warrants, net of financing costs $ 10 287,410 287,420
Issuance of common stock and warrants, net of financing costs, shares   9,598      
Exchange of warrants into common stock $ 13 49,265 49,278
Exchange of warrants into common stock, shares   12,019      
Vesting of restricted stock
Vesting of restricted stock, shares   250      
Balance at Mar. 31, 2023 $ 1,275 51,387,943 (57,775,306) (6,386,088)
Balance, shares at Mar. 31, 2023 1,274,601      
Net loss (1,823,107) (1,823,107)
Stock-based compensation expense 41,259 41,259
Issuance of common stock and warrants, net of financing costs $ 10 152,898 152,908
Issuance of common stock and warrants, net of financing costs, shares   10,608      
Balance at Jun. 30, 2023 $ 1,285 51,582,100 (59,598,413) (8,015,028)
Balance, shares at Jun. 30, 2023 1,285,209      
Balance at Sep. 30, 2023 $ 4,689 54,543,188 (62,055,609) (7,507,732)
Balance, shares at Sep. 30, 2023 4,689,446      
Net loss (2,681,652) (2,681,652)
Issuance of common stock upon conversion of convertible notes $ 53 587,906 587,959
Issuance of common stock upon conversion of convertible notes, shares   52,918      
Stock-based compensation expense 25,909 25,909
Balance at Dec. 31, 2023 $ 4,742 55,157,003 (64,737,261) (9,575,516)
Balance, shares at Dec. 31, 2023 4,742,364      
Balance at Sep. 30, 2023 $ 4,689 54,543,188 (62,055,609) (7,507,732)
Balance, shares at Sep. 30, 2023 4,689,446      
Net loss         (9,805,472)
Balance at Jun. 30, 2024 $ 4,444 60,026,073 (72,591,083) (12,560,566)
Balance, shares at Jun. 30, 2024 4,444,364      
Balance at Dec. 31, 2023 $ 4,742 55,157,003 (64,737,261) (9,575,516)
Balance, shares at Dec. 31, 2023 4,742,364      
Net loss (1,469,139) (1,469,139)
Issuance of common stock upon conversion of convertible notes $ 2 18,278 18,280
Issuance of common stock upon conversion of convertible notes, shares   2,000      
Issuance of common stock and warrants, net of financing costs 148,891 148,891
Issuance of common stock and warrants, net of financing costs, shares        
Exchange of warrants into common stock $ (300) 300
Exchange of warrants into common stock, shares   (300,000)      
Balance at Mar. 31, 2024 $ 4,444 55,324,472 (66,206,400) (10,877,484)
Balance, shares at Mar. 31, 2024 4,444,364      
Net loss (5,654,681) (5,654,681)
Stock-based compensation expense 10,323 10,323
Issuance of warrants for financing 3,961,276 3,961,276
Deemed dividends for down round provision in warrants 730,002 (730,002)
Balance at Jun. 30, 2024 $ 4,444 $ 60,026,073 $ (72,591,083) $ (12,560,566)
Balance, shares at Jun. 30, 2024 4,444,364      
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash flows from operating activities:    
Net loss $ (9,805,472) $ (4,525,640)
Adjustments to reconcile net loss to cash used in operating activities:    
Depreciation 1,585 1,316
Stock-based compensation 36,232 213,809
Fair value of warrants issued accounted as financing expense 3,961,276
Gain on extinguishment of derivative liabilities (1,158,197)
Accretion of discount and debt issuance costs on convertible notes payable 1,852,588 1,480,121
Changes in operating asset and liabilities:    
Inventory 44,228 31,910
Prepaid expenses and other current assets 322,041 345,869
Accounts payable 612,449 1,143,162
Accrued interest 560,922 488,153
Accrued expenses and other liabilities (60,254) (167,983)
Net cash used in operating activities (2,474,405) (2,147,480)
Cash flows from financing activities:    
Repayment of insurance premium financing (243,285) (247,933)
Shareholder advances related to bridge financing 1,228,015
Proceeds from unsecured convertible notes 450,000 507,000
Proceeds from senior secured convertible notes 2,075,000
Net cash provided by financing activities 2,281,715 1,487,082
Net decrease in cash (192,690) (660,398)
Cash, beginning of period 222,720 746,940
Cash, end of period 30,030 86,542
Non-cash financing activities:    
Exchange of Convertible notes payable, Series 2, unsecured and accrued interest into common stock 606,239
Relative fair value of warrants issued – convertible notes payable, unsecured 148,891
Deemed dividends on warrants upon trigger of down round provision 730,002
Exchange of Series G and Series H warrants for common stock 49,278
Issuance of restricted stock 3,019
Fair value of warrants issued - second close 256,439
Fair value of inducement shares issued – second close 25,840
Fair value of placement agent warrants – second close 28,093
Fair value of warrants issued – third close 137,252
Fair value of inducement shares issued – third close 15,656
Conversion of shareholder advance into unsecured convertible note $ 488,000
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
9 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Arch Therapeutics, Inc. (together with its subsidiary, the “Company” or “Arch”) is a biotechnology company developing and marketing products based on our innovative AC5® self-assembling technology platform. The Company’s products are in the field of stasis and barrier applications, which includes managing wounds created during surgery, trauma or interventional care, or from disease; stopping bleeding (hemostasis); and controlling leaking (sealant).

 

Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. We believe that the disclosures contained in these condensed financial statements are adequate to make the information presented herein not misleading. These condensed financial statements should be read in conjunction with the financial statements contained in the Company’s Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC. The accompanying condensed financial statements are unaudited, but in the opinion of management contain all adjustments, including normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. The balance sheet as of September 30, 2023 is derived from the Company’s audited financial statements. The results of operations for the three and nine months ended June 30, 2024 are not necessarily indicative of the results of operations to be expected for the full fiscal year ending September 30, 2024.

 

In accordance with the “Segment Reporting” Topic of the Accounting Standards Codification, the Company’s chief operating decision maker (the Company’s President and Chief Executive Officer) determined that the Company has only one reporting unit.

 

The condensed consolidated financial statements include the accounts of Arch Therapeutics, Inc. and its wholly owned subsidiary, Arch Biosurgery, Inc., a biotechnology company. All intercompany accounts and transactions have been eliminated in consolidation.

 

Going Concern

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. As reflected in the accompanying condensed financial statements, for the nine months ended June 30, 2024, the Company recorded a net loss of $9,805,472 and used cash in operating activities of $2,474,405. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s September 30, 2023, financial statements, raised substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its current and its potential future products. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. In evaluating the going concern position of the Company, management has considered potential funding providers and believes that financing to fund future operations could be provided by equity and/or debt financing. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

 

Reverse stock split

 

On January 6, 2023, the directors of the Company authorized a reverse share split of the issued and outstanding Common Shares in a ratio of 1:200, effective January 17, 2023. Accordingly, all share and per share amounts presented herein with respect to common stock have been retroactively adjusted to reflect the above-described reverse stock split for all periods presented.

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Use of Estimates

 

Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expense during the reporting periods. Significant estimates include the assumptions used in the accrual for potential liabilities, the net realizable value of inventory, the valuation of debt and equity instruments, the fair value of derivative liabilities, valuation of equity instruments issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

 

Revenue

 

The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers (“ASC 606”), through a five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied.

 

The Company’s source of revenue is product sales. Contracts with customers contain a single performance obligation and the Company recognizes revenue from product sales when the Company has satisfied our performance obligation by transferring control of the product to the customers. Control of the product transfers to the customer upon shipment from the Company’s third-party warehouse. In circumstances where the transaction price is not able to be determined at the time of shipment, the Company does not recognize revenue or any receivable amount until such time that the final transaction price is established.

 

Cost of Revenue

 

Cost of revenue includes product costs, warehousing, overhead allocation and royalty expense.

 

Research and Development

 

The Company expenses internal and external research and development costs, including costs of funded research and development arrangements, in the period incurred.

 

Accounting for Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”), which requires all share-based payments be recognized in the condensed consolidated financial statements based on their fair values. In accordance with ASC 718, the Company has elected to use the Black-Scholes Option Pricing Model (the “Black-Scholes Model”) to determine the fair value of options granted and recognizes the compensation cost of share-based awards on a straight-line basis over the vesting period of the award.

 

The determination of the fair value of share-based payment awards utilizing the Black-Scholes model is affected by the fair value of the Common Stock and a number of other assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The expected life for awards uses the simplified method for all “plain vanilla” options, as defined in ASC 718-10-S99, and the contractual term for all other employee and non-employee awards. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the Company’s awards. The dividend yield assumption is based on history and the expectation of paying no dividends. Stock-based compensation expense, when recognized in the condensed consolidated financial statements, is based on awards that are ultimately expected to vest.

 

Fair Value Measurements

 

The Company measures both financial and nonfinancial assets and liabilities in accordance with FASB ASC Topic 820, Fair Value Measurements and Disclosures, including those that are recognized or disclosed in the condensed consolidated financial statements at fair value on a recurring basis. The standard created a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable inputs that reflect the Company’s own views about the assumptions market participants would use in pricing the asset or liability.

 

At June 30, 2024 and September 30, 2023, the carrying amounts of cash, accounts payables and accrued expense and other liabilities approximate fair value because of their short-term nature. The carrying amounts of the convertible notes payable, senior secured, convertible notes payable, unsecured and convertible notes payable, Series 2, unsecured, approximate fair value because borrowing rates and terms are similar to comparable market participants.

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Warrants

 

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company has determined that the warrants issued in June 2018 and May 2019 equity financing (see Note 3) meet the requirements for liability classification. During the nine months ended June 30, 2023, $1,158,197 was recorded to gain on extinguishment of derivative liability for the exchange of the Series G warrants and Series H warrants to 12,019 shares of common stock with a fair value of $49,278.

 

Loss per Common Share

 

Basic earnings (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding during the year, excluding shares of unvested restricted common stock. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from the time they vest. Diluted earnings (loss) per share is computed by dividing the net income applicable to common stockholders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. Shares of restricted stock are included in the diluted weighted average number of common shares outstanding from the date they are granted. Potential common shares are excluded from the computation when their effect is antidilutive.

 

For the three and nine months ended June 30, 2024, the Company recorded a deemed dividend of $730,002 as a result of a triggered down-round feature in the Company’s warrants, and as a result, the amount was reflected as an increase to the net loss attributed to common shareholders in the basic EPS calculation.

 

  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
   For the three months ended   For the nine months ended 
  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
                 
Net loss  $(5,654,681)  $(1,823,107)  $(9,805,472)  $(4,525,640)
Deemed dividend   (730,002)       (730,002)    
Net loss attributed to common shareholders, numerator, basic computation  $(6,384,683)  $(1,823,107)  $(10,535,474)  $(4,525,640)

 

For the periods ended June 30, 2024 and 2023, the calculations of basic and diluted loss per share are the same because potentially dilutive securities would have had an anti-dilutive effect. The potentially dilutive securities consisted of the following:

 

  

June 30,

2024

  

June 30,

2023

 
         
Stock options   88,275    104,325 
Stock warrants   29,736,656    988,417 
Convertible notes payable   18,776,444    798,675 
Total   48,601,375    1,891,417 

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash. The Company maintains its cash in bank deposits accounts, which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash.

 

Risks and uncertainties – Geopolitical Conflicts

 

The Company sources its materials and services for its products and product candidates from facilities in areas impacted or which may be impacted by the outbreak of geopolitical conflicts. The Company’s ability to obtain future inventory may be impacted, therefore potentially affecting the Company’s future revenue stream. In addition, the Company has historically and principally funded its operations through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of Common Stock and warrants which may also be impacted by economic conditions beyond the Company’s control as well as uncertainties resulting from geopolitical conflicts. The extent to which recent events, including recent wars in Ukraine and Israel/Gaza, will impact the global economy and the Company is uncertain and cannot be reasonably measured.

v3.24.2.u1
INVENTORIES
9 Months Ended
Jun. 30, 2024
Inventory Disclosure [Abstract]  
INVENTORIES

2. INVENTORIES

 

Inventories consist of the following:

 

   June 30,   September 30, 
   2024   2023 
Finished Goods  $56,663   $40,969 
Goods-in-Process   1,263,613    1,323,535 
Total  $1,320,276   $1,364,504 

 

Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out (“FIFO”) basis. The cost of inventories comprises expenditures incurred in acquiring the inventories, the cost of conversion and other costs incurred in bringing them to their existing location and condition. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. Once inventory has been written down, it creates a new cost basis for inventory that may not be subsequently written up. For the periods ended June 30, 2024 and 2023, the Company did not record any write-down of inventories.

 

v3.24.2.u1
WARRANT DERIVATIVE LIABILITY
9 Months Ended
Jun. 30, 2024
Warrant Derivative Liability  
WARRANT DERIVATIVE LIABILITY

3. WARRANT DERIVATIVE LIABILITY

 

As of June 30, 2024 and September 30, 2023, there are no financial instruments accounted as a derivative liability.

 

The Company previously issued warrants (Series G and Series H warrants) that were accounted for the in accordance with ASC 815-10 as the Company is required to purchase the Series G, and Series H warrants for an amount of cash per share equal to $22.00 and $10.66, respectively, (the “Minimum Value”). Accordingly, the warrants were recorded as liabilities at the greater of the Minimum Value or fair value at each reporting period.

 

During the nine months ended June 30, 2023, the Company issued 12,019 shares of common stock with a fair value of $49,278 in exchange for the cancellation of the Series G and Series H warrants. As a result, during the three-month ended March 31, 2023, the Company recorded a gain of $1,158,197 to account for the extinguishment of derivative liability.

 

v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SENIOR SECURED
9 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
CONVERTIBLE NOTES PAYABLE, SENIOR SECURED

4. CONVERTIBLE NOTES PAYABLE, SENIOR SECURED

 

  

June 30,

2024

  

September 30,

2023

 
Senior Secured Convertible Promissory Notes (the “2022 Notes”)  $4,211,720   $4,230,000 
Senior Secured Convertible Promissory Notes (the “2024 First Notes”)   2,490,000     
Unamortized debt discount       (710,897)
Net balance  $6,701,720   $3,519,103 

 

2022 Notes

 

In July 2022, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain institutional and accredited individual investors and issued Senior Secured Convertible Promissory Notes (the “2022 Notes”) in the aggregate of $4,230,000 in exchange for cash proceeds of $3,525,000, net of original issue discount (OID) of $705,000.

 

The 2022 Notes are secured by tangible and intangible assets of the Company, bears interest at a rate of 10% per annum payable at maturity or upon conversion, matures on September 15, 2024, as amended.

 

Repricing of conversion price

 

The 2022 Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that lowers the conversion price if the Company sells shares of common stock or issues convertible debt convertible at a lower price per share. In May and June 2004 the Company issued notes (the “2024 First Notes”, see below) convertible into common stock of the Company at an exercise price of $0.50 per share, resulting in a triggering event lowering the conversion price of the 2022 Notes to $0.50 per share. The Company adopted ASU 2020-06 on October 1, 2022, and following the guidance of ASU 2020-06, no discount was recorded for any incremental value created by the triggering event.

 

Other

 

The 2022 Notes contain customary events of default such as automatic increase in the notes’ stated interest rate. Further, events of default under the 2022 Notes also include (i) the unavailability of Rule 144 on or after January 6, 2023; (ii) our failure to deliver the shares of common stock to the 2022 Note holder upon exercise by such holder of its conversion rights under the 2022 Note; (iii) our loss of the “bid” price for its common stock and/or a market and such loss is not cured during the specified cure periods; and (iv) our failure to complete an uplisting of our Common Stock to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American by April 30, 2024 (the “Uplist Transaction”). During the year ended September 2023, for no additional consideration, the 2022 Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date for the Uplist Transaction, and amend certain provisions with regards to mandatory conversion of the notes upon the Uplist Transaction.

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

In connection with the issuance of the 2022 Notes, the Company granted the 2022 Notes noteholders 425,555 warrants to purchase shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company estimated the relative fair value of the warrants to be $1,470,000 using the Black Scholes option pricing model. The Company also issued note holders 63,834 shares of the Company’s common stock with a relative fair value of $315,000. The Company also issued 31,510 warrants to purchase shares of common stock to the placement agent that assisted in the 2022 Notes offering. The placement agent warrants are fully vested, exercisable at $10.06 per share and will expire in 5 years. The Company estimated the relative fair value of the placement agent warrants to be $108,000 using the Black Scholes option pricing model. The Company incurred direct legal and professional fees of $271,000 as part of this offering.

 

The Company recorded 2022 Notes with total principal of $4,230,000. In addition, total debt discount of $2,870,000 was recorded to account for the 2022 Notes OID of $705,000, the relative fair value of the warrants of $1,578,000, the relative fair value of common stock issued of $315,000, and direct legal and professional fees incurred in the 2022 Notes offering of $271,000. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

Subsequent to issuance, for no additional consideration, the 2022 Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction.

 

On February 14, 2024, the Company entered into an amendment to the 2022 Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the 2022 Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the 2022 Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

As of September 30, 2023, outstanding balance of the 2022 Notes payable was $4,230,000 and unamortized debt discount was $710,897, or a net balance of $3,519,103. On December 26, 2023, the Company issued a total of 2,000 shares of Common Stock with a fair value of $18,280 in partial satisfaction of the outstanding Senior Secured Convertible Promissory Notes with the principal balance of $18,280. During the nine months ended June 30, 2024, the Company amortized debt discount of $710,897. As of June 30, 2024, the outstanding balance of the 2022 Notes payable amounted to $4,211,720 and no unamortized debt discount was remaining.

 

2024 First Notes

 

In May and June 2024, the Company issued senior secured convertible promissory notes (the “2024 First Notes”) in the aggregate of $2,490,000 in exchange for cash of $2,075,000, net of original issue discount (OID) of $415,000. The 2024 First Notes are secured by the Company’s tangible and intangible assets, bears interest at a rate of 10% per annum, convertible to common stock at a conversion price of $0.50 per share. The 2024 First Notes originally matured June 30, 2024, and were amended to mature on August 15, 2024. The OID was recorded as a debt discount and was amortized in full to interest expense over the original term of the notes payable.

 

The 2024 First Notes also contain customary events of default similar to the 2022 Notes. Furthermore, upon the closing of a transaction that results in the Uplist of the Company’s common stock to a national exchange, 100% of the outstanding principal of the 2024 First Notes will automatically convert into shares of common stock at a conversion price of $0.515625 per share. In addition, each Note Holder shall receive (i) a warrant to purchase a number of shares of common stock equal to the number of shares of common stock issued upon automatic conversion following the Uplist transaction with an exercise price of $0.50 per share and (ii) pre-funded warrants in lieu of common shares otherwise issuable to each Note Holder with an exercise price of $0.000125.

 

On June 30, 2024, the 2024 First Notes were amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the 2024 First Notes were amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

During the three and nine months ended June 30, 2024, the Company amortized debt discount of $415,000. As of June 30, 2024, the outstanding balance of the 2024 First Notes amounted to $2,490,000 and no unamortized debt discount was remaining.

v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, UNSECURED
9 Months Ended
Jun. 30, 2024
Convertible Notes Payable Unsecured  
CONVERTIBLE NOTES PAYABLE, UNSECURED

5. CONVERTIBLE NOTES PAYABLE, UNSECURED

 

  

June 30,

2024

  

September 30,

2023

 
Exchanged notes (July 2022)  $699,781   $699,781 
Second closing notes (January 2023)   636,000    636,000 
Third closing notes (March, April, May, 2023)   702,720    702,720 
Fourth closing notes (March 2024)   648,000     
Total   2,686,501    2,038,501 
Unamortized debt discount       (379,799)
Net balance  $2,686,501   $1,658,702 

 

Exchanged Notes (July 2022)

 

In relation to the issuance of the 2022 Notes (see Note 4), certain noteholders of the Company’s Series 2 note payable agreed to exchange their Series 2 notes payable consisting of $600,000 principal and accrued interest of $99,781 for $699,781 of Unsecured Convertible Promissory Notes (the “Exchanged Notes”) on substantially the same terms as the 2022 Notes, except that the Exchanged Notes are subordinate to the 2022 Notes and are unsecured. The notes bear interest at a rate of 10% per annum payable at maturity or upon conversion, mature September 15, 2024, as amended. The Exchanged Notes also contain customary events of default similar to the 2022 Notes (see Note 4). The Exchanged Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

Subsequent to issuance, for no additional consideration, the Exchanged Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction. On June 30, 2024, the Exchanged Notes were again amended in order to extend the maturity date to August 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Exchanged Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Second Closing Notes (January 2023)

 

In January 2023, the Company issued Unsecured Convertible Promissory Notes (the “Second Closing Notes”) in the aggregate of $636,000 in exchange for cash proceeds of $530,000, net of original issue discount (OID) of $106,000. The notes are unsecured, bear interest at a rate of 10% per annum, matures on September 15, 2024, as amended. The Second Closing Notes also contain customary events of default similar to the 2022 Notes (see Note 4). The Second Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Second Closing Notes, the Company granted the Second Closing Notes noteholders 127,968 warrants to purchase shares of common stock and 9,589 shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company determined the relative fair value of the warrants to be $256,000 and the relative fair value of the 9,598 shares of common stock to be $26,000. The Company also issued 6,565 placement agent warrants to purchase shares of the Company’s common stock. The placement agent warrants are fully vested, exercisable at $10.06 per share and will expire in 5 years. The Company determined the relative fair value of the placement agent warrants to be $13,000. Furthermore, the Company also incurred direct legal and professional fees of $31,000 as part of this offering.

 

The Company recorded debt discount totaling $432,000 to account for the direct legal and professional fees, OID and the relative fair value of the warrants and common stock. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

On February 14, 2024, the Company entered into an amendment to the Second Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the Second Closing Notes were again amended in order to extend the maturity date to August 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Second Closing Notes were again amended in order to extend the maturity date to September 15, 2024.  There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Third Closing Notes (March, April and May 2023)

 

In March, April and May 2023, the Company issued Unsecured Convertible Promissory Notes (the “Third Closing Notes”) in the aggregate of $702,720 in exchange for cash proceeds of $488,000, net of original issue discount (OID) of $215,000, and. The notes are unsecured, bear interest at a rate of 10% per annum, matures on June 30, 2024, as amended . The Third Closing Notes contain events of default similar to the 2022 Notes. The Third Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Third Closing Notes, the Company granted the Third Closing Notes noteholders 141,396 warrants to purchase shares of common stock and 10,608 shares of common stock. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years. The Company determined the relative fair value of the warrants to be $164,000, and the relative fair value of the 10,608 shares of common stock to be $18,000. The Company also incurred direct legal and professional fees of $5,000 as part of this offering.

 

The Company recorded debt discount totaling $402,000 to account for the direct legal and professional fees, OID and the relative fair value of the warrants and common stock. The debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

Subsequent to issuance, for no additional consideration, the Third Closing Notes were amended several times in order to allow the Company to issue additional notes payable, extend the completion date of the Uplist Transaction, and amend certain provisions with regards mandatory conversion of the notes upon the Uplist Transaction.

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

On February 14, 2024, the Company entered into an amendment to the Third Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price of $0.50 per share.

 

On June 30, 2024, the Third Closing Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Third Closing Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

Fourth Closing Notes (March 2024)

 

On March 12, 2024, investors agreed to purchase Unsecured Convertible Promissory Notes (the “Fourth Closing Notes”) in the aggregate principal amount of $648,000 in exchange for cash proceeds of $450,000, net of an OID of $198,000. The notes are unsecured, bears interest at a rate of 10% per annum. The Forth Closing Notes originally matured June 30, 2024, and were amended to mature on August 15, 2024. The Forth Closing Notes were originally convertible into shares of the Company’s common stock at a conversion price of $9.14 per share, subject to a down-round anti-dilution provision that was triggered in May 2024 (see Note 4) and resulted in the conversion price being reduced to $0.50 per share.

 

In connection with the issuance of the Fourth Closing Notes, the Company granted the Fourth Closing Notes noteholders 130,383 warrants to purchase shares of common stock and 9,782 pre-funded warrants. The warrants are fully vested, exercisable at $0.50 per share, as effected by the down round provision, and expire in 5 years, and prefunded warrants have similar terms, however, are exercisable at $0.001 per share. The Company determined the relative fair value of the warrants and pre-funded warrants to be approximately $148,891.

 

The Company recorded debt discount totaling $346,891 to account for the OID and the relative fair value of the warrants. During the three months ended June 30, 2023, the debt discount was amortized in full over the original term of the notes using the effective interest rate method.

 

On February 14, 2024, the Company entered into an amendment to the Forth Closing Notes, under which 95% of the principal amount of the Notes shall automatically convert, upon the closing of an Uplist Transaction, as defined, with a conversion price of $0.50 per share, into pre-funded warrants with an exercise price of $0.000125 per share, exercisable immediately. In addition, the note holder shall receive a warrant to purchase 80 times the dollar amount of the notes that are converted, with an exercise price per share of $0.50.

 

On June 30, 2024, the Fourth Closing Notes were again amended in order to extend the maturity date to August 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

On August 15, 2024, the Fourth Closing Notes were again amended in order to extend the maturity date to September 15, 2024. There was no compensation provided to the noteholder nor any changes in the other terms of the notes payable.

 

v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SERIES 2
9 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
CONVERTIBLE NOTES PAYABLE, SERIES 2

6. CONVERTIBLE NOTES PAYABLE, SERIES 2

 

  

June 30,

2024

  

September 30,

2023

 
Series 2 Convertible Notes (converted in November 2023)  $   $450,000 

 

On November 6, 2020, the Company issued its unsecured Series 2 10% Convertible Notes Payable in exchange for cash proceeds of $450,000.

 

On November 30, 2023, upon maturity, the Series 2 Convertible Notes of $450,000 and outstanding accrued interest of $137,946, were converted into 52,918 shares of the Company’s common stock.

 

v3.24.2.u1
STOCKHOLDERS DEFICIT
9 Months Ended
Jun. 30, 2024
Equity [Abstract]  
STOCKHOLDERS DEFICIT

7. STOCKHOLDERS DEFICIT

 

Common Stock

 

In January 2024 certain shareholders of the Company exchanged a total of 300,000 shares of Company’s Common Stock for 300,073 of pre-funded warrants to purchase shares of Common Stock. At the date of the exchange, the fair value of the common stock received approximates the fair value of the warrants issued. The pre-funded warrants are fully vested, exercisable at $0.001 per share, and expire in 5 years.

 

2013 Stock Incentive Plan

 

On September 1, 2023, a majority of shareholders approved the 2023 Stock Plan with 455,169 common shares reserved to be issued under the plan. As of June 30, 2024, there were no issuances under the new plan.

 

On June 18, 2013, the Company established the 2013 Stock Incentive Plan (the “2013 Plan”). Under the 2013 Plan, the Company can issue or grant a total of 185,571 shares, as amended. On June 18, 2023, the 2013 Stock Incentive Plan expired, and no shares are available for grants under the 2013 Plan.

 

 

ARCH THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

Common Stock Options

 

Stock compensation activity under the 2013 Plan for the nine months ended June 30, 2024 follows:

 

  

Option

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   102,125   $38.00    5.58   $ 
Awarded                
Forfeited/Cancelled   (1,825)   (67.00)        
Outstanding at December 31, 2023   100,300    38.00    4.00    11,000 
Awarded                
Forfeited/Cancelled   (12,025)   (58.00)        
Outstanding at March 31, 2024   88,275   $35.00    5.00     
Awarded                
Forfeited/Cancelled   (250)   (58.00)        
Outstanding at June 30, 2024   88,025    35.00    4.00     
Vested at June 30, 2024   77,812   $40.00    3.25     

 

During the nine months ended June 30, 2024 and 2023, the Company recorded stock compensation expense of $36,232 and $210,789 to account the fair value of the stock options that vested.

 

As of June 30, 2024, there is approximately $34,397 of unrecognized compensation expense related to unvested stock-based compensation arrangements granted under the 2013 Plan. The unrecognized compensation expense will be recognized over a weighted average vesting period of 1.18 years.

 

Common Stock Warrants

 

Common Stock Warrants activity for the nine months ended June 30, 2024 follows:

 

SCHEDULE OF STOCK WARRANTS ACTIVITY

  

Warrant

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   26,284,002   $0.85    4.80   $13,958,846 
Awarded                
Forfeited/Cancelled                
Outstanding at December 31, 2023   26,284,002    0.74    4.51    170,879,690 
Awarded   440,238    0.15    4.75      
Forfeited/Cancelled                
Outstanding at March 31, 2024   26,724,240   $0.73    4.28    32,897,525 
Awarded   3,012,416    0.10    4.89      
Forfeited/Cancelled                
Outstanding at June 30, 2024   29,736,656   $0.67    4.12   $15,092,000 
Vested at June 30, 2024   29,736,656   $0.67           

 

During the three months ended June 30, 2024, the Company issued warrants to purchase an aggregate of 3,012,416 shares of common stock to a number of investors as compensation for participation in debt and equity financing activities of the Company. The warrants were valued as of the dates of the issuances using the Black-Scholes Model, resulting an aggregate fair value of $3,961,276, which was recorded as financing expense. The warrants have exercise prices ranging between $0.000125 and $0.50 per share, have a term of 5 years, and are exercisable immediately.

 

Warrant Repricing

 

The Company had 29,736,656 warrants outstanding, including 19,661,911 warrants with exercise prices above $0.50 per share that were subject to a down-round anti-dilution provision. In May 2024 the Company issued notes (the “2024 First Notes”, see Note 4) convertible into common stock of the Company at an exercise price of $0.50 per share, resulting in a triggering event lowering the conversion price of the 19,661,191 warrants to $0.50 per share. When a down round provision is triggered, a financial impact due to the difference between the fair value of the warrants post-adjustment and their fair value immediately prior to the adjustment is recognized as deemed dividends. As a result, the Company recorded deemed dividends of $730,002 in our condensed consolidated financial statements for the three month and nine-month periods ended June 30, 2024.

 

Restricted Stock

 

For the three months ended June 30, 2024 and 2023, compensation expense recorded for the restricted stock awards was approximately $0, respectively. For the nine months ended June 30, 2024 and 2023, compensation expense recorded for the restricted stock awards was approximately $0 and $3,000, respectively.

 

As of June 30, 2024, there was no unrecognized compensation expense related to unvested restricted stock.

 

v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
9 Months Ended
Jun. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS AND CONTINGENCIES

8. COMMITMENTS AND CONTINGENCIES

 

Periodically, the Company reviews the status of any significant matters that exist and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.

 

As of June 30, 2024, and September 30, 2023, no amounts have been accrued related to such matters.

 

v3.24.2.u1
SUBSEQUENT EVENTS
9 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

9. SUBSEQUENT EVENTS

 

In July 2024, investors agreed to purchase Secured Convertible Promissory Notes (“the Fourth and Fifth Closing 2024 Notes”) in the aggregate principal amount of $264,000 in exchange for cash proceeds of $220,000, net of an OID of $44,000. These notes are secured by tangible and intangible assets of the Company, bears interest at rate of 10% per annum, convertible to common stock at a conversion rate of $0.50 and will mature on August 15, 2024.

 

In July 2024, the Company executed a loan agreement of approximately $230,000 to finance the Company’s insurance premiums for fiscal years 2024 and 2025. The loan is secured by the Company’s tangible and intangible assets, bears interest at a rate of 8.48% per annum, payable on a monthly installment basis of approximately $24,000 and will mature July 2025.

 

In August 2024, investors agreed to purchase Secured Convertible Promissory Notes (“the Sixth Closing 2024 Notes”) in the aggregate principal amount of $105,000 in exchange for cash proceeds of $87,500, net of an OID of $17,500. These notes are secured by tangible and intangible assets of the Company, bears interest at rate of 10% per annum, convertible to common stock at a conversion rate of $0.50 and will mature on August 15, 2024.

 

In August 2024, the Company also entered into Amendment No. 18 to the First 2022 Notes, Amendment No. 18 to the Second 2022 Notes, Amendment No. 13 to the Third 2022 Notes, Amendment No. 4 to the Fourth 2022 Notes, and Amendment No. 2 to the First 2024 Notes (together, the “Amendments to the Notes”). Under the Amendments to the Notes, the First 2022 Notes, Second 2022 Notes, Third 2022 Notes, Fourth 2022 Notes, and First 2024 Notes (which, for the avoidance of doubt, are the first through sixth closings of the First 2024 Notes) (together, the “Notes”) were amended to extend the date of the completion of an “Uplist” (as defined therein) and to extend the respective maturity date of each of the Notes from August 15, 2024 to September 15, 2024.

v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
9 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of presentation

Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. We believe that the disclosures contained in these condensed financial statements are adequate to make the information presented herein not misleading. These condensed financial statements should be read in conjunction with the financial statements contained in the Company’s Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC. The accompanying condensed financial statements are unaudited, but in the opinion of management contain all adjustments, including normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. The balance sheet as of September 30, 2023 is derived from the Company’s audited financial statements. The results of operations for the three and nine months ended June 30, 2024 are not necessarily indicative of the results of operations to be expected for the full fiscal year ending September 30, 2024.

 

In accordance with the “Segment Reporting” Topic of the Accounting Standards Codification, the Company’s chief operating decision maker (the Company’s President and Chief Executive Officer) determined that the Company has only one reporting unit.

 

The condensed consolidated financial statements include the accounts of Arch Therapeutics, Inc. and its wholly owned subsidiary, Arch Biosurgery, Inc., a biotechnology company. All intercompany accounts and transactions have been eliminated in consolidation.

 

Going Concern

Going Concern

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. As reflected in the accompanying condensed financial statements, for the nine months ended June 30, 2024, the Company recorded a net loss of $9,805,472 and used cash in operating activities of $2,474,405. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s September 30, 2023, financial statements, raised substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its current and its potential future products. The Company has not yet generated sufficient revenues to fund operations and relies on issuance of debt and equity instruments to generate working capital. In evaluating the going concern position of the Company, management has considered potential funding providers and believes that financing to fund future operations could be provided by equity and/or debt financing. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

 

Reverse stock split

Reverse stock split

 

On January 6, 2023, the directors of the Company authorized a reverse share split of the issued and outstanding Common Shares in a ratio of 1:200, effective January 17, 2023. Accordingly, all share and per share amounts presented herein with respect to common stock have been retroactively adjusted to reflect the above-described reverse stock split for all periods presented.

Use of Estimates

Use of Estimates

 

Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expense during the reporting periods. Significant estimates include the assumptions used in the accrual for potential liabilities, the net realizable value of inventory, the valuation of debt and equity instruments, the fair value of derivative liabilities, valuation of equity instruments issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

 

Revenue

Revenue

 

The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers (“ASC 606”), through a five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied.

 

The Company’s source of revenue is product sales. Contracts with customers contain a single performance obligation and the Company recognizes revenue from product sales when the Company has satisfied our performance obligation by transferring control of the product to the customers. Control of the product transfers to the customer upon shipment from the Company’s third-party warehouse. In circumstances where the transaction price is not able to be determined at the time of shipment, the Company does not recognize revenue or any receivable amount until such time that the final transaction price is established.

 

Cost of Revenue

Cost of Revenue

 

Cost of revenue includes product costs, warehousing, overhead allocation and royalty expense.

 

Research and Development

Research and Development

 

The Company expenses internal and external research and development costs, including costs of funded research and development arrangements, in the period incurred.

 

Accounting for Stock-Based Compensation

Accounting for Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”), which requires all share-based payments be recognized in the condensed consolidated financial statements based on their fair values. In accordance with ASC 718, the Company has elected to use the Black-Scholes Option Pricing Model (the “Black-Scholes Model”) to determine the fair value of options granted and recognizes the compensation cost of share-based awards on a straight-line basis over the vesting period of the award.

 

The determination of the fair value of share-based payment awards utilizing the Black-Scholes model is affected by the fair value of the Common Stock and a number of other assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The expected life for awards uses the simplified method for all “plain vanilla” options, as defined in ASC 718-10-S99, and the contractual term for all other employee and non-employee awards. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the Company’s awards. The dividend yield assumption is based on history and the expectation of paying no dividends. Stock-based compensation expense, when recognized in the condensed consolidated financial statements, is based on awards that are ultimately expected to vest.

 

Fair Value Measurements

Fair Value Measurements

 

The Company measures both financial and nonfinancial assets and liabilities in accordance with FASB ASC Topic 820, Fair Value Measurements and Disclosures, including those that are recognized or disclosed in the condensed consolidated financial statements at fair value on a recurring basis. The standard created a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3 inputs are unobservable inputs that reflect the Company’s own views about the assumptions market participants would use in pricing the asset or liability.

 

At June 30, 2024 and September 30, 2023, the carrying amounts of cash, accounts payables and accrued expense and other liabilities approximate fair value because of their short-term nature. The carrying amounts of the convertible notes payable, senior secured, convertible notes payable, unsecured and convertible notes payable, Series 2, unsecured, approximate fair value because borrowing rates and terms are similar to comparable market participants.

Warrants

Warrants

 

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company has determined that the warrants issued in June 2018 and May 2019 equity financing (see Note 3) meet the requirements for liability classification. During the nine months ended June 30, 2023, $1,158,197 was recorded to gain on extinguishment of derivative liability for the exchange of the Series G warrants and Series H warrants to 12,019 shares of common stock with a fair value of $49,278.

 

Loss per Common Share

Loss per Common Share

 

Basic earnings (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding during the year, excluding shares of unvested restricted common stock. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from the time they vest. Diluted earnings (loss) per share is computed by dividing the net income applicable to common stockholders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. Shares of restricted stock are included in the diluted weighted average number of common shares outstanding from the date they are granted. Potential common shares are excluded from the computation when their effect is antidilutive.

 

For the three and nine months ended June 30, 2024, the Company recorded a deemed dividend of $730,002 as a result of a triggered down-round feature in the Company’s warrants, and as a result, the amount was reflected as an increase to the net loss attributed to common shareholders in the basic EPS calculation.

 

  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
   For the three months ended   For the nine months ended 
  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
                 
Net loss  $(5,654,681)  $(1,823,107)  $(9,805,472)  $(4,525,640)
Deemed dividend   (730,002)       (730,002)    
Net loss attributed to common shareholders, numerator, basic computation  $(6,384,683)  $(1,823,107)  $(10,535,474)  $(4,525,640)

 

For the periods ended June 30, 2024 and 2023, the calculations of basic and diluted loss per share are the same because potentially dilutive securities would have had an anti-dilutive effect. The potentially dilutive securities consisted of the following:

 

  

June 30,

2024

  

June 30,

2023

 
         
Stock options   88,275    104,325 
Stock warrants   29,736,656    988,417 
Convertible notes payable   18,776,444    798,675 
Total   48,601,375    1,891,417 

 

Concentration of Credit Risk

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash. The Company maintains its cash in bank deposits accounts, which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash.

 

Risks and uncertainties – Geopolitical Conflicts

Risks and uncertainties – Geopolitical Conflicts

 

The Company sources its materials and services for its products and product candidates from facilities in areas impacted or which may be impacted by the outbreak of geopolitical conflicts. The Company’s ability to obtain future inventory may be impacted, therefore potentially affecting the Company’s future revenue stream. In addition, the Company has historically and principally funded its operations through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of Common Stock and warrants which may also be impacted by economic conditions beyond the Company’s control as well as uncertainties resulting from geopolitical conflicts. The extent to which recent events, including recent wars in Ukraine and Israel/Gaza, will impact the global economy and the Company is uncertain and cannot be reasonably measured.

v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
9 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
SCHEDULE OF DEEMED DIVIDEND

For the three and nine months ended June 30, 2024, the Company recorded a deemed dividend of $730,002 as a result of a triggered down-round feature in the Company’s warrants, and as a result, the amount was reflected as an increase to the net loss attributed to common shareholders in the basic EPS calculation.

 

  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
   For the three months ended   For the nine months ended 
  

June 30,

2024

  

June 30,

2023

  

June 30,

2024

  

June 30,

2023

 
                 
Net loss  $(5,654,681)  $(1,823,107)  $(9,805,472)  $(4,525,640)
Deemed dividend   (730,002)       (730,002)    
Net loss attributed to common shareholders, numerator, basic computation  $(6,384,683)  $(1,823,107)  $(10,535,474)  $(4,525,640)

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE POTENTIAL DILUTIVE SECURITIES

For the periods ended June 30, 2024 and 2023, the calculations of basic and diluted loss per share are the same because potentially dilutive securities would have had an anti-dilutive effect. The potentially dilutive securities consisted of the following:

 

  

June 30,

2024

  

June 30,

2023

 
         
Stock options   88,275    104,325 
Stock warrants   29,736,656    988,417 
Convertible notes payable   18,776,444    798,675 
Total   48,601,375    1,891,417 
v3.24.2.u1
INVENTORIES (Tables)
9 Months Ended
Jun. 30, 2024
Inventory Disclosure [Abstract]  
SCHEDULE OF INVENTORIES

Inventories consist of the following:

 

   June 30,   September 30, 
   2024   2023 
Finished Goods  $56,663   $40,969 
Goods-in-Process   1,263,613    1,323,535 
Total  $1,320,276   $1,364,504 
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SENIOR SECURED (Tables)
9 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
SCHEDULE OF CONVERTIBLE NOTES PAYABLE, SENIOR SECURED

 

  

June 30,

2024

  

September 30,

2023

 
Senior Secured Convertible Promissory Notes (the “2022 Notes”)  $4,211,720   $4,230,000 
Senior Secured Convertible Promissory Notes (the “2024 First Notes”)   2,490,000     
Unamortized debt discount       (710,897)
Net balance  $6,701,720   $3,519,103 
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, UNSECURED (Tables)
9 Months Ended
Jun. 30, 2024
Convertible Notes Payable Unsecured  
SCHEDULE OF CONVERTIBLE NOTES PAYABLE UNSECURED

 

  

June 30,

2024

  

September 30,

2023

 
Exchanged notes (July 2022)  $699,781   $699,781 
Second closing notes (January 2023)   636,000    636,000 
Third closing notes (March, April, May, 2023)   702,720    702,720 
Fourth closing notes (March 2024)   648,000     
Total   2,686,501    2,038,501 
Unamortized debt discount       (379,799)
Net balance  $2,686,501   $1,658,702 
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SERIES 2 (Tables)
9 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
SCHEDULE OF CONVERTIBLE NOTES PAYABLE, SERIES 2

 

  

June 30,

2024

  

September 30,

2023

 
Series 2 Convertible Notes (converted in November 2023)  $   $450,000 
v3.24.2.u1
STOCKHOLDERS DEFICIT (Tables)
9 Months Ended
Jun. 30, 2024
Equity [Abstract]  
SCHEDULE OF STOCK OPTIONS ACTIVITY

Stock compensation activity under the 2013 Plan for the nine months ended June 30, 2024 follows:

 

  

Option

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   102,125   $38.00    5.58   $ 
Awarded                
Forfeited/Cancelled   (1,825)   (67.00)        
Outstanding at December 31, 2023   100,300    38.00    4.00    11,000 
Awarded                
Forfeited/Cancelled   (12,025)   (58.00)        
Outstanding at March 31, 2024   88,275   $35.00    5.00     
Awarded                
Forfeited/Cancelled   (250)   (58.00)        
Outstanding at June 30, 2024   88,025    35.00    4.00     
Vested at June 30, 2024   77,812   $40.00    3.25     
SCHEDULE OF STOCK WARRANTS ACTIVITY

Common Stock Warrants activity for the nine months ended June 30, 2024 follows:

 

SCHEDULE OF STOCK WARRANTS ACTIVITY

  

Warrant

Shares

Outstanding

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Term

(years)

  

Aggregate

Intrinsic

Value

 
Outstanding at September 30, 2023   26,284,002   $0.85    4.80   $13,958,846 
Awarded                
Forfeited/Cancelled                
Outstanding at December 31, 2023   26,284,002    0.74    4.51    170,879,690 
Awarded   440,238    0.15    4.75      
Forfeited/Cancelled                
Outstanding at March 31, 2024   26,724,240   $0.73    4.28    32,897,525 
Awarded   3,012,416    0.10    4.89      
Forfeited/Cancelled                
Outstanding at June 30, 2024   29,736,656   $0.67    4.12   $15,092,000 
Vested at June 30, 2024   29,736,656   $0.67           
v3.24.2.u1
SCHEDULE OF DEEMED DIVIDEND (Details) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Jun. 30, 2023
Mar. 31, 2023
Dec. 31, 2022
Jun. 30, 2024
Jun. 30, 2023
Accounting Policies [Abstract]                
Net loss $ (5,654,681) $ (1,469,139) $ (2,681,652) $ (1,823,107) $ (902,477) $ (1,800,056) $ (9,805,472) $ (4,525,640)
Deemed dividend (730,002)         (730,002)
Net loss attributed to common shareholders, numerator, basic computation $ (6,384,683)     $ (1,823,107)     $ (10,535,474) $ (4,525,640)
v3.24.2.u1
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE POTENTIAL DILUTIVE SECURITIES (Details) - shares
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 48,601,375 1,891,417
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 88,275 104,325
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 29,736,656 988,417
Convertible Debt Securities [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 18,776,444 798,675
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)
3 Months Ended 9 Months Ended
Jan. 17, 2023
Jun. 30, 2024
USD ($)
Segment
Mar. 31, 2024
USD ($)
Dec. 31, 2023
USD ($)
Jun. 30, 2023
USD ($)
Mar. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Jun. 30, 2024
USD ($)
Jun. 30, 2023
USD ($)
shares
Class of Warrant or Right [Line Items]                  
Number of reporting units | Segment   1              
Net loss   $ 5,654,681 $ 1,469,139 $ 2,681,652 $ 1,823,107 $ 902,477 $ 1,800,056 $ 9,805,472 $ 4,525,640
Cash used in operating activities               2,474,405 2,147,480
Reverse stock split description the directors of the Company authorized a reverse share split of the issued and outstanding Common Shares in a ratio of 1:200, effective January 17, 2023                
Gain loss on sale of derivatives           1,158,197
Deemed dividend   $ 730,002         $ 730,002
Series G and H Warrants [Member]                  
Class of Warrant or Right [Line Items]                  
Gain loss on sale of derivatives           $ 1,158,197     $ 1,158,197
Issuance of common stock shares | shares                 12,019
Fair value of common stock                 $ 49,278
v3.24.2.u1
SCHEDULE OF INVENTORIES (Details) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Inventory Disclosure [Abstract]    
Finished Goods $ 56,663 $ 40,969
Goods-in-Process 1,263,613 1,323,535
Total $ 1,320,276 $ 1,364,504
v3.24.2.u1
INVENTORIES (Details Narrative) - USD ($)
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Inventory Disclosure [Abstract]    
Inventory write down $ 0 $ 0
v3.24.2.u1
WARRANT DERIVATIVE LIABILITY (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Sep. 30, 2023
Offsetting Assets [Line Items]            
Gain loss on sale of derivatives   $ 1,158,197  
Series G Warrant [Member]            
Offsetting Assets [Line Items]            
Warrants purchase price per share $ 22.00     $ 22.00    
Series H Warrant [Member]            
Offsetting Assets [Line Items]            
Warrants purchase price per share $ 10.66     $ 10.66    
Series G and H Warrants [Member]            
Offsetting Assets [Line Items]            
Issuance of common stock shares         12,019  
Fair value of common stock         $ 49,278  
Gain loss on sale of derivatives     $ 1,158,197   $ 1,158,197  
Derivative Warrant Liability [Member]            
Offsetting Assets [Line Items]            
Derivative liabilities $ 0     $ 0   $ 0
v3.24.2.u1
SCHEDULE OF CONVERTIBLE NOTES PAYABLE, SENIOR SECURED (Details) - USD ($)
Jun. 30, 2024
May 31, 2024
Sep. 30, 2023
2022 Notes [Member]      
Short-Term Debt [Line Items]      
Senior Secured Convertible Promissory Notes $ 4,211,720   $ 4,230,000
2024 First Notes [Member]      
Short-Term Debt [Line Items]      
Senior Secured Convertible Promissory Notes 2,490,000 $ 2,490,000  
Senior Secured Convertible Notes [Member]      
Short-Term Debt [Line Items]      
Unamortized debt discount   (710,897)
Net balance 6,701,720   3,519,103
Senior Secured Convertible Notes [Member] | 2022 Notes [Member]      
Short-Term Debt [Line Items]      
Senior Secured Convertible Promissory Notes 4,211,720   4,230,000
Senior Secured Convertible Notes [Member] | 2024 First Notes [Member]      
Short-Term Debt [Line Items]      
Senior Secured Convertible Promissory Notes $ 2,490,000  
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SENIOR SECURED (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Jun. 30, 2024
Dec. 26, 2023
Jul. 31, 2022
Jun. 30, 2024
May 31, 2024
Jul. 31, 2022
Jun. 30, 2024
Jun. 30, 2024
Jun. 30, 2023
Jul. 31, 2024
Jun. 28, 2024
May 30, 2024
Feb. 14, 2024
Jan. 31, 2024
Sep. 30, 2023
Short-Term Debt [Line Items]                              
Cash proceeds               $ 2,075,000            
Placement Agent Warrants [Member]                              
Short-Term Debt [Line Items]                              
Warrants to purchase common shares     31,510     31,510                  
Warrant exercise price     $ 10.06     $ 10.06                  
Warrant expiration term     5 years     5 years                  
Fair value of warrants     $ 108,000     $ 108,000                  
Common Stock [Member] | 2022 Notes Noteholders [Member]                              
Short-Term Debt [Line Items]                              
New issues of common stock     63,834                        
Debt instrument Principal amount     $ 315,000                        
Warrant [Member] | 2022 Notes Noteholders [Member]                              
Short-Term Debt [Line Items]                              
Warrants to purchase common shares     425,555     425,555                  
Warrant exercise price     $ 0.50     $ 0.50                  
Warrant expiration term     5 years     5 years                  
Fair value of warrants     $ 1,470,000     $ 1,470,000                  
Prefunded Warrants [Member]                              
Short-Term Debt [Line Items]                              
Warrant exercise price                           $ 0.001  
Warrant expiration term                           5 years  
2022 Notes [Member]                              
Short-Term Debt [Line Items]                              
Debt instrument face amount     4,230,000     4,230,000                  
Cash proceeds           3,525,000                  
Original issue discount     $ 705,000     $ 705,000                  
Debt Instrument, Interest Rate, Stated Percentage     10.00%     10.00%             95.00%    
Conversion price per share $ 0.50     $ 0.50 $ 0.50   $ 0.50 $ 0.50       $ 0.50 $ 0.50    
Common stock exercise price $ 0.50     $ 0.50 $ 0.50   $ 0.50 $ 0.50              
Fair value of warrants     $ 1,578,000     $ 1,578,000                  
New issues of common stock   2,000                          
Debt instrument Principal amount   $ 18,280       315,000                  
Direct legal and professional fees     271,000     271,000                  
Debt discount     $ 2,870,000     $ 2,870,000                  
Debt Instrument, Maturity Date Aug. 15, 2024                            
Outstanding notes payable $ 4,211,720     $ 4,211,720     $ 4,211,720 $ 4,211,720             $ 4,230,000
Unamortized debt discount 0     0     0 0             710,897
Net amount                             $ 3,519,103
Amortized debt discount               710,897              
2022 Notes [Member] | Common Stock [Member]                              
Short-Term Debt [Line Items]                              
Conversion price per share     $ 9.14     $ 9.14                  
2022 Notes [Member] | Warrant [Member]                              
Short-Term Debt [Line Items]                              
Warrant exercise price                         0.50    
2022 Notes [Member] | Prefunded Warrants [Member]                              
Short-Term Debt [Line Items]                              
Warrant exercise price                         $ 0.000125    
2024 First Notes [Member]                              
Short-Term Debt [Line Items]                              
Cash proceeds       2,075,000 $ 2,075,000                    
Original issue discount $ 415,000     $ 415,000 $ 415,000   $ 415,000 $ 415,000              
Debt Instrument, Interest Rate, Stated Percentage                   10.00% 10.00%   100.00%    
Conversion price per share                     $ 0.50   $ 0.515625    
Common stock exercise price $ 0.50     $ 0.50     $ 0.50 $ 0.50              
Warrants to purchase common shares 19,661,911     19,661,911 19,661,191   19,661,911 19,661,911              
Warrant exercise price $ 0.50     $ 0.50     $ 0.50 $ 0.50              
Outstanding notes payable $ 2,490,000     $ 2,490,000 $ 2,490,000   $ 2,490,000 $ 2,490,000              
Unamortized debt discount $ 0     $ 0     0 0              
Amortized debt discount             $ 415,000 $ 415,000              
2024 First Notes [Member] | Warrant [Member]                              
Short-Term Debt [Line Items]                              
Warrant exercise price                         0.50    
2024 First Notes [Member] | Prefunded Warrants [Member]                              
Short-Term Debt [Line Items]                              
Warrant exercise price                         $ 0.000125    
v3.24.2.u1
SCHEDULE OF CONVERTIBLE NOTES PAYABLE UNSECURED (Details) - Unsecured Convertible Notes [Member] - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Short-Term Debt [Line Items]    
Total $ 2,686,501 $ 2,038,501
Unamortized debt discount (379,799)
Net balance 2,686,501 1,658,702
Exchange Notes [Member]    
Short-Term Debt [Line Items]    
Total 699,781 699,781
Second Closing Notes [Member]    
Short-Term Debt [Line Items]    
Total 636,000 636,000
Third Closing Notes [Member]    
Short-Term Debt [Line Items]    
Total 702,720 702,720
Fourth Closing Notes [Member]    
Short-Term Debt [Line Items]    
Total $ 648,000
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, UNSECURED (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Jun. 30, 2024
Mar. 12, 2024
Dec. 26, 2023
Jan. 31, 2023
Jul. 31, 2022
May 31, 2023
Jan. 31, 2023
Jul. 31, 2022
May 31, 2023
Jun. 30, 2024
Jun. 30, 2023
May 31, 2024
May 30, 2024
Feb. 14, 2024
Jan. 31, 2024
Sep. 30, 2023
Mar. 31, 2023
Nov. 06, 2020
Short-Term Debt [Line Items]                                    
Interest Payable, Current $ 1,246,092                 $ 1,246,092           $ 823,128    
Debt Conversion, Converted Instrument, Amount                   $ 606,239              
Placement Agent Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrants to purchase shares         31,510     31,510                    
Warrant exercise price         $ 10.06     $ 10.06                    
Warrants expiration term         5 years     5 years                    
Fair value of warrants         $ 108,000     $ 108,000                    
Prefunded Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrant exercise price                             $ 0.001      
Warrants expiration term                             5 years      
Series 2 Convertible Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument face amount         600,000     600,000                   $ 450,000
Interest Payable, Current         $ 99,781     99,781                    
Interest rate                                   10.00%
Unsecured Convertible Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt Conversion, Converted Instrument, Amount               $ 699,781                    
Exchange Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Interest rate         10.00%     10.00%                    
Maturity date               Sep. 15, 2024                    
2022 Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument face amount         $ 4,230,000     $ 4,230,000                    
Interest rate         10.00%     10.00%           95.00%        
Maturity date Aug. 15, 2024                                  
Debt instrument conversion price $ 0.50                 $ 0.50   $ 0.50 $ 0.50 $ 0.50        
Original issue discount         $ 705,000     $ 705,000                    
Number of shares issued     2,000                              
Fair value of warrants         1,578,000     1,578,000                    
Shares issued, value     $ 18,280         315,000                    
Professional Fees         $ 271,000     $ 271,000                    
2022 Notes [Member] | Common Stock [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument conversion price         $ 9.14     $ 9.14                    
2022 Notes [Member] | Warrant [Member]                                    
Short-Term Debt [Line Items]                                    
Warrant exercise price                           0.50        
2022 Notes [Member] | Prefunded Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrant exercise price                           $ 0.000125        
Second Closing Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Interest rate                           95.00%        
Debt instrument conversion price                           $ 0.50        
Number of shares issued             9,589                      
Warrants expiration term       5 years     5 years                      
Payment of financing and stock issuance costs             $ 31,000                      
Debt discount       $ 432,000                            
Second Closing Notes [Member] | Placement Agent Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrants to purchase shares       6,565     6,565                      
Warrant exercise price       $ 10.06     $ 10.06                      
Warrants expiration term       5 years     5 years                      
Fair value of warrants       $ 13,000     $ 13,000                      
Second Closing Notes [Member] | Unsecured Convertible Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument face amount       $ 636,000     $ 636,000                      
Interest rate       10.00%     10.00%                      
Maturity date             Sep. 15, 2024                      
Debt instrument conversion price                         0.50          
Proceeds from convertible notes             $ 530,000                      
Original issue discount       $ 106,000     $ 106,000                      
Second Closing Notes [Member] | Common Stock [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument conversion price       $ 9.14     $ 9.14                      
Number of shares issued             9,598                      
Shares issued, value             $ 26,000                      
Second Closing Notes [Member] | Warrant [Member]                                    
Short-Term Debt [Line Items]                                    
Warrants to purchase shares       127,968     127,968                      
Warrant exercise price       $ 0.50     $ 0.50             0.50        
Fair value of warrants       $ 256,000     $ 256,000                      
Second Closing Notes [Member] | Prefunded Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrant exercise price                           $ 0.000125        
Third Closing Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Interest rate                           95.00%        
Debt instrument conversion price                           $ 0.50        
Debt discount       402,000                            
Professional Fees                 $ 5,000                  
Third Closing Notes [Member] | Unsecured Convertible Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument face amount           $ 702,720     $ 702,720                  
Interest rate           10.00%     10.00%                  
Maturity date           Jun. 30, 2024                        
Debt instrument conversion price           $ 9.14     $ 9.14                  
Proceeds from convertible notes                 $ 488,000                  
Original issue discount                                 $ 215,000  
Third Closing Notes [Member] | Common Stock [Member]                                    
Short-Term Debt [Line Items]                                    
Number of shares issued                 10,608                  
Shares issued, value                 $ 18,000                  
Third Closing Notes [Member] | Warrant [Member]                                    
Short-Term Debt [Line Items]                                    
Warrants to purchase shares           141,396     141,396                  
Warrant exercise price           $ 0.50     $ 0.50         0.50        
Warrants expiration term           5 years     5 years                  
Fair value of warrants           $ 164,000     $ 164,000                  
Third Closing Notes [Member] | Prefunded Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Warrant exercise price                           $ 0.000125        
Fourth Closing Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Interest rate                           95.00%        
Debt instrument conversion price                           $ 0.50        
Fair value of warrants           $ 148,891     $ 148,891                  
Debt discount       $ 346,891                            
Fourth Closing Notes [Member] | Unsecured Convertible Notes [Member]                                    
Short-Term Debt [Line Items]                                    
Debt instrument face amount   $ 648,000                                
Interest rate   10.00%                                
Maturity date   Aug. 15, 2024                                
Debt instrument conversion price   $ 9.14                     $ 0.50          
Proceeds from convertible notes   $ 450,000                                
Original issue discount   $ 198,000                                
Fourth Closing Notes [Member] | Warrant [Member]                                    
Short-Term Debt [Line Items]                                    
Warrants to purchase shares   130,383                                
Warrant exercise price   $ 0.50                       0.50        
Warrants expiration term   5 years                                
Fourth Closing Notes [Member] | Prefunded Warrants [Member]                                    
Short-Term Debt [Line Items]                                    
Number of shares issued   9,782                                
Warrant exercise price   $ 0.001                       $ 0.000125        
v3.24.2.u1
SCHEDULE OF CONVERTIBLE NOTES PAYABLE, SERIES 2 (Details) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Series 2 Convertible Notes [Member]    
Short-Term Debt [Line Items]    
Series 2 Convertible Notes (converted in November 2023) $ 450,000
v3.24.2.u1
CONVERTIBLE NOTES PAYABLE, SERIES 2 (Details Narrative) - Series 2 Convertible Notes [Member] - USD ($)
Nov. 30, 2023
Jul. 31, 2022
Nov. 06, 2020
Short-Term Debt [Line Items]      
Debt Instrument, Interest Rate, Stated Percentage     10.00%
Debt Instrument, Face Amount   $ 600,000 $ 450,000
Notes outstanding amount converted $ 450,000    
Accrued interest converted $ 137,946    
Common shares issued upon conversion 52,918    
v3.24.2.u1
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - USD ($)
3 Months Ended 12 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Sep. 30, 2023
Equity [Abstract]        
Outstanding, Option Shares Outstanding 88,275 100,300 102,125  
Outstanding, Weighted Average Exercise Price $ 35.00 $ 38.00 $ 38.00  
Outstanding, Weighted Average Remaining Contractual Term (Year)       5 years 6 months 29 days
Outstanding, Aggregate Intrinsic Value $ 11,000  
Awarded, Option Shares Outstanding  
Awarded, Weighted Average Exercise Price  
Forfeited/Cancelled, Option Shares Outstanding (250) (12,025) (1,825)  
Forfeited/Cancelled, Weighted Average Exercise Price $ (58.00) $ (58.00) $ (67.00)  
Outstanding, Weighted Average Remaining Contractual Term (Year) 4 years 5 years 4 years  
Outstanding, Option Shares Outstanding 88,025 88,275 100,300 102,125
Outstanding, Weighted Average Exercise Price $ 35.00 $ 35.00 $ 38.00 $ 38.00
Outstanding, Aggregate Intrinsic Value $ 11,000
Vested, Option Shares Outstanding 77,812      
Vested, Weighted Average Exercise Price $ 40.00      
Vested, Weighted Average Remaining Contractual Term (Years) 3 years 3 months      
Vested, Aggregate Intrinsic Value      
v3.24.2.u1
SCHEDULE OF STOCK WARRANTS ACTIVITY (Details) - Common Stock Warrants [Member] - USD ($)
3 Months Ended 12 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Outstanding, Warrant Shares 26,724,240 26,284,002 26,284,002  
Outstanding, Weighted Average Exercise Price $ 0.73 $ 0.74 $ 0.85  
Outstanding, Weighted Average Contractual Term (Year) 4 years 1 month 13 days 4 years 3 months 10 days 4 years 6 months 3 days 4 years 9 months 18 days
Outstanding, Aggregate Intrinsic Value $ 32,897,525 $ 170,879,690 $ 13,958,846  
Awarded, Warrant Shares Outstanding 3,012,416 440,238  
Awarded, Weighted Average Exercise Price $ 0.10 $ 0.15  
Forfeited/Cancelled, Warrant Shares Outstanding  
Forfeited/Cancelled, Weighted Average Exercise Price  
Awarded, Weighted Average Contractual Term (Year)   4 years 10 months 20 days 4 years 9 months  
Forfeited/Cancelled, Warrant Shares Outstanding  
Outstanding, Warrant Shares 29,736,656 26,724,240 26,284,002 26,284,002
Outstanding, Weighted Average Exercise Price $ 0.67 $ 0.73 $ 0.74 $ 0.85
Outstanding, Aggregate Intrinsic Value $ 15,092,000 $ 32,897,525 $ 170,879,690 $ 13,958,846
Vested, awards (in shares) 29,736,656      
Vested, Weighted Average Exercise Price $ 0.67      
v3.24.2.u1
STOCKHOLDERS DEFICIT (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Jan. 31, 2024
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
May 31, 2024
Mar. 31, 2024
Feb. 14, 2024
Dec. 31, 2023
Sep. 30, 2023
Sep. 01, 2023
Jun. 18, 2013
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Common stock converted 300,000                      
Stock option compensation expense       $ 36,232 $ 210,789              
Deemed dividends   $ 730,002 730,002              
Restricted stock compensation expense   $ 0 $ 0 $ 0 $ 3,000              
Common Stock Warrants [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Outstanding, warrant shares   29,736,656   29,736,656     26,724,240   26,284,002 26,284,002    
2024 First Notes [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrant exercise prices   $ 0.50   $ 0.50                
Warrant shares   19,661,911   19,661,911   19,661,191            
Common stock exercise price   $ 0.50   $ 0.50                
Warrant triggering price per share       $ 0.50                
2024 First Notes [Member] | Common Stock Warrants [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Outstanding, warrant shares   29,736,656   29,736,656                
Common Stock Warrants [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrant expiration term   5 years   5 years                
Shares issued upon warrant exercise   3,012,416                    
Fair value of warrants   $ 3,961,276   $ 3,961,276                
Common Stock Warrants [Member] | Maximum [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrant exercise prices   $ 0.000125   $ 0.000125                
Common Stock Warrants [Member] | Minimum [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrant exercise prices   $ 0.50   $ 0.50                
2023 Stock Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Common stock reserved for issuance                     455,169  
Number of shares issued       0                
2013 Stock Incentive Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Number of shares granted                       185,571
Unrecognized compensation expense of options   $ 34,397   $ 34,397                
Unrecognized compensation expense, period for recognition       1 year 2 months 4 days                
Unrecognized compensation expense of restricted stock   $ 0   $ 0                
Prefunded Warrants [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrants issued upon conversion 300,073                      
Warrant exercise prices $ 0.001                      
Warrant expiration term 5 years                      
Prefunded Warrants [Member] | 2024 First Notes [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Warrant exercise prices               $ 0.000125        
v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
1 Months Ended
Aug. 31, 2024
Jul. 31, 2024
Aug. 31, 2024
Jul. 31, 2024
Jun. 30, 2024
Jun. 28, 2024
May 31, 2024
Feb. 14, 2024
2024 First Notes [Member]                
Subsequent Event [Line Items]                
Original issue discount         $ 415,000   $ 415,000  
Interest rate   10.00%   10.00%   10.00%   100.00%
Debt Instrument, Convertible, Conversion Price           $ 0.50   $ 0.515625
Sixth Closing Two Thousand Twenty Four Notes [Member]                
Subsequent Event [Line Items]                
Interest rate 10.00%   10.00%          
Subsequent Event [Member] | Loan Agreement [Member]                
Subsequent Event [Line Items]                
Debt instrument face amount   $ 230,000   $ 230,000        
Interest rate   8.48%   8.48%        
Debt instrument periodic payment       24,000        
Subsequent Event [Member] | Secured Convertible Notes [Member] | Fourth Closing 2024 First Notes [Member]                
Subsequent Event [Line Items]                
Debt instrument face amount   $ 264,000   $ 264,000        
Original issue discount   44,000   $ 44,000        
Subsequent Event [Member] | Secured Convertible Notes [Member] | Fourth And Fifth Closing Two Thousand Twenty Four Notes [Member]                
Subsequent Event [Line Items]                
Proceeds from convertible debt   $ 220,000            
Debt Instrument, Convertible, Conversion Price   $ 0.50   $ 0.50        
Debt instrument Principal amount       Aug. 15, 2024        
Subsequent Event [Member] | Secured Convertible Notes [Member] | Sixth Closing Two Thousand Twenty Four Notes [Member]                
Subsequent Event [Line Items]                
Debt instrument face amount $ 105,000   $ 105,000          
Proceeds from convertible debt 87,500              
Original issue discount $ 17,500   $ 17,500          
Debt Instrument, Convertible, Conversion Price $ 0.50   $ 0.50          
Debt instrument Principal amount     Aug. 15, 2024          

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