UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
For the quarterly period ended
For the transition period from N/A to N/A
Commission File Number:
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(I.R.S. Employer Identification No.) |
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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.
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).
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 ☐ |
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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
As of May 22, 2023,
ARCH THERAPEUTICS, INC.
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
PART I – FINANCIAL INFORMATION |
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Item 1. Consolidated Financial Statements |
1 |
Consolidated Balance Sheets as of March 31, 2023 (unaudited) and September 30, 2022 |
1 |
Consolidated Statements of Operations for the Three and Six months ended March 31, 2023 and March 31, 2022 (unaudited) |
2 |
Consolidated Statements of Changes in Stockholders’ Deficit for the Three and Six months ended March 31, 2023 and March 31, 2022 (unaudited) |
3 |
Consolidated Statements of Cash Flows for the Six months ended March 31, 2023 and March 31, 2022 (unaudited) |
4 |
Notes to Consolidated Financial Statements (unaudited) |
5 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
19 |
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
29 |
Item 4. Controls and Procedures |
29 |
PART II - OTHER INFORMATION |
30 |
Item 1. Legal Proceedings |
30 |
Item 1A. Risk Factors |
30 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
30 |
Item 6. Exhibits |
33 |
Arch Therapeutics, Inc. and Subsidiary |
Consolidated Balance Sheets |
As of March 31, 2023 (Unaudited) and September 30, 2022 |
March 31, 2023 |
September 30, 2022 |
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ASSETS | ||||||||
Current assets: | ||||||||
Cash |
$ | $ | ||||||
Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Long-term assets: | ||||||||
Property and equipment, net |
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Other assets |
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Total long-term assets |
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Total assets |
$ | $ | ||||||
LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ | $ | ||||||
Shareholder advances |
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Accrued expenses and other liabilities |
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Insurance premium financing |
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Current Portion of Series 2 convertible note |
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Current Portion of Series 1 convertible note | - | |||||||
Current Portion of Unsecured convertible notes | ||||||||
Current Portion of 2022 Notes |
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Current Portion of Accrued Interest |
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Current portion of derivative liability |
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Total current liabilities |
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Long-term liabilities: | ||||||||
Unsecured convertible notes | ||||||||
Series 2 convertible notes |
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2022 Notes |
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Accrued interest |
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Derivative liability |
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Total long-term liabilities |
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Total liabilities |
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Commitments and contingencies |
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Stockholders’ deficit: | ||||||||
Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
( |
) |
( |
) |
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Total stockholders’ deficit |
( |
) |
( |
) |
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Total liabilities and stockholders’ deficit |
$ | $ |
The accompanying notes are an integral part of these consolidated financial statements. |
Arch Therapeutics, Inc. and Subsidiary |
Consolidated Statements of Operations (Unaudited) |
For the Three and Six Months Ended March 31, 2023 and 2022 |
Three Months Ended March 31, 2023 |
Three Months Ended March 31, 2022 |
Six Months Ended March 31, 2023 |
Six Months Ended March 31, 2022 |
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Revenue |
$ | $ | $ | $ | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of revenues |
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Selling, general and administrative expenses |
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Research and development expenses |
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Total costs and expenses |
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Loss from operations |
( |
) |
( |
) |
( |
) | ( |
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Other income (expense): | ||||||||||||||||
Interest expense |
( |
) |
( |
) |
( |
) | ( |
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Gain on extinguishment of derivative liabilities | ||||||||||||||||
Expiration of derivative liability/Series F warrant | ||||||||||||||||
Total other income (expense) | ( |
) | ||||||||||||||
Net loss |
$ | ( |
) |
$ | ( |
) |
$ | ( |
) | $ | ( |
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Loss per share - basic and diluted | ||||||||||||||||
Net loss per common share - basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Weighted common shares - basic and diluted |
The accompanying notes are an integral part of these consolidated financial statements. |
Arch Therapeutics, Inc. and Subsidiary |
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Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) |
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For the Three and Six Months Ended March 31, 2023 and 2022 |
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Additional |
Total |
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Common Stock |
Paid-in |
Accumulated |
Stockholders' |
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Three Months Ended March 31, 2023 |
Shares | Amount | Capital | Deficit | Deficit | |||||||||||||||
Balance at December 31, 2022 |
$ | $ | $ | ( |
) | ( |
) | |||||||||||||
Net loss |
- | ( |
) | ( |
) | |||||||||||||||
Vesting of restricted stock |
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Stock-based compensation expense |
- | - | ||||||||||||||||||
Issuance of common stock and warrants, net of financing costs |
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Exchange of warrants into common stock |
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Balance at March 31, 2023 |
$ | $ | $ | ( |
) | $ | ( |
) |
Additional |
Total |
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Common Stock |
Paid-in |
Accumulated |
Stockholders' |
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Six Months Ended March 31, 2023 |
Shares |
Amount |
Capital |
Deficit |
Deficit |
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Balance at September 30, 2022 |
$ | $ | $ | ( |
) | ( |
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Net loss |
- | ( |
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Vesting of restricted stock |
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Stock-based compensation expense |
- | |||||||||||||||||||
Issuance of common stock and warrants, net of financing costs |
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Exchange of warrants into common stock |
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Balance at March 31, 2023 |
$ | $ | $ | ( |
) | $ | ( |
) |
Additional |
Total |
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Common Stock |
Paid-in |
Accumulated |
Stockholders' |
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Three Months Ended March 31, 2022 |
Shares | Amount | Capital | Deficit | Equity (Deficit) | |||||||||||||||
Balance at December 31, 2021 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
Net loss |
- | - | - | ( |
) | ( |
) | |||||||||||||
Vesting of restricted stock |
( |
) | ||||||||||||||||||
Stock-based compensation expense |
- | - | - | |||||||||||||||||
Balance at March 31, 2022 |
$ | $ | $ | ( |
) |
$ | ( |
) |
Additional |
Total |
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Common Stock |
Paid-in |
Accumulated |
Stockholders' |
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Six Months Ended March 31, 2022 |
Shares |
Amount |
Capital |
Deficit |
Deficit |
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Balance at September 30, 2021 |
$ | $ | $ | ( |
) | $ | ( |
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Net loss |
- | ( |
) | ( |
) | |||||||||||||||
Vesting of restricted stock |
( |
) | ||||||||||||||||||
Stock-based compensation expense |
- | |||||||||||||||||||
Balance at March 31, 2022 |
$ | $ | $ | ( |
) | $ | ( |
) |
The accompanying notes are an integral part of these consolidated financial statements. |
Arch Therapeutics, Inc. and Subsidiary |
Consolidated Statements of Cash Flows (Unaudited) |
For the Six Months Ended March 31, 2023 and 2022 |
Six Months Ended March 31, 2023 |
Six Months Ended March 31, 2022 |
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Cash flows from operating activities: | ||||||||
Net loss |
$ | ( |
) |
$ | ( |
) |
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Adjustments to reconcile net loss to cash used in operating activities: | ||||||||
Depreciation |
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Stock-based compensation |
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Decrease to fair value of derivative |
( |
) | ||||||
Gain on extinguishment of derivative liabilities | ( |
) | ||||||
Accretion of discount and debt issuance costs on 2022 Notes and Unsecured convertible notes |
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Inventory obsolescence charge |
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Changes in operating assets and liabilities: | ||||||||
(Increase) decrease in: | ||||||||
Inventory |
( |
) | ||||||
Prepaid expenses and other current assets |
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Increase (decrease) in: | ||||||||
Accounts payable |
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Accrued interest |
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Accrued expenses and other current liabilities |
( |
) |
( |
) |
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Net cash used in operating activities |
( |
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( |
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Cash flows from financing activities: | ||||||||
Repayment of insurance premium financing |
( |
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Proceeds from shareholder advances |
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Proceeds from Unsecured convertible notes | ||||||||
Net cash provided by financing activities |
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Net decrease in cash |
( |
) | ( |
) | ||||
Cash, beginning of year |
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Cash, end of period |
$ | $ | ||||||
Non-cash financing activities: | ||||||||
Exchange of Series G and Series H warrants for common stock |
$ | $ | ||||||
Issuance of restricted stock |
$ | $ | ||||||
Fair value of warrants issued - second close | $ | $ | ||||||
Fair value of inducement shares issued - second close | $ | $ | ||||||
Fair value of placement agent warrants - second close | $ | $ |
The accompanying notes are an integral part of these consolidated financial statements. |
ARCH THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. BASIS OF PRESENTATION AND DESCRIPTION OF BUSINESS
Organization and Description of Business
Arch Therapeutics, Inc. (together with its subsidiary, the “Company” or “Arch”) was incorporated under the laws of the State of Nevada on September 16, 2009, under the name “Almah, Inc.”. Effective June 26, 2013, the Company completed a merger (the “Merger”) with Arch Biosurgery, Inc. (formerly known as Arch Therapeutics, Inc.), a Massachusetts corporation (“ABS”), and Arch Acquisition Corporation (“Merger Sub”), the Company’s wholly owned subsidiary formed for the purpose of the transaction, pursuant to which Merger Sub merged with and into ABS and ABS thereby became the wholly owned subsidiary of the Company. As a result of the acquisition of ABS, the Company abandoned its prior business plan and changed its operations to the business of a biotechnology company. The Company’s principal offices are located in Framingham, Massachusetts.
ABS was incorporated under the laws of the Commonwealth of Massachusetts on March 6, 2006, as Clear Nano Solutions, Inc. On April 7, 2008, ABS changed its name from Clear Nano Solutions, Inc. to Arch Therapeutics, Inc. Effective upon the closing of the Merger, ABS changed its name from Arch Therapeutics, Inc. to Arch Biosurgery, Inc.
In the first quarter of 2021, the Company commenced commercial sales of our first product, AC5® Advanced Wound System, and has devoted substantially all of the Company’s operational effort to the research, development and regulatory programs necessary to turn the Company’s core technology into commercial products. To date, the Company has principally raised capital through the issuance of convertible debt, and the issuance of units consisting of its common stock, $
The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its potential future 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 consolidated financial statements do not include any adjustments related to the recoverability of assets that might be necessary despite this uncertainty.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The interim consolidated financial statements included herein are unaudited; however, they contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the Company’s results of operations and financial position for the interim periods.
Although the Company believes that the disclosures in these unaudited interim consolidated financial statements are adequate to make the information presented not misleading, certain information normally included in the footnotes prepared in accordance with US GAAP has been omitted as permitted by the rules and regulations of the Securities and Exchange Commission (“SEC”). These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2022, filed with the SEC on December 28, 2022 (the “Annual Report”).
For a complete summary of the Company’s significant accounting policies, please refer to Note 2 included in Item 8 of the Company’s Annual Report. There have been no material changes to the Company’s significant accounting policies during the six months ended March 31, 2023.
3. PROPERTY AND EQUIPMENT
At March 31, 2023 and September 30, 2022, property and equipment consisted of:
Estimated |
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Useful Life (in years) |
March 31, 2023 |
September 30, 2022 |
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Furniture and fixtures |
$ | $ | ||||||||||
Leasehold improvements |
Life of Lease | |||||||||||
Computer equipment |
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Lab equipment |
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Less – accumulated depreciation |
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Property and equipment, net |
$ | $ |
For the three months ended March 31, 2023 and 2022, depreciation expense recorded was $
4. INVENTORIES
Inventories consist of the following:
March 31, |
September 30, |
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2022 |
2022 |
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Finished Goods |
$ | $ | ||||||
Goods-in-process |
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Total |
$ | $ |
The Company capitalizes inventory that has been produced for commercial sale and has been determined to have a probable future economic benefit. The determination of whether or not the inventory has a future economic benefit requires estimates by management. To the extent that inventory is expected to expire prior to being sold or used for research and development or used for samples, the Company will write down the value of inventory. In evaluating the net realizable value of the inventory, appropriate consideration is given to obsolescence, excessive levels, deterioration, and other factors.
5. INSURANCE PREMIUM FINANCING
In July 2022, the Company entered into a finance agreement with First Insurance Funding in order to fund a portion of its insurance policies. The amount financed is approximately $
6. STOCK-BASED COMPENSATION
2013 Stock Incentive Plan
On June 18, 2013, the Company established the 2013 Stock Incentive Plan (the “2013 Plan”). Under the 2013 Plan, as of September 30, 2022, a maximum number of
The exercise price of each option is equal to the closing price of a share of the Company’s Common Stock on the date of grant.
Share-Based Awards
During the six months ended March 31, 2023, the Company awarded
Share-based compensation expense for awards granted during the six months ended March 31, 2023 was based on the grant date fair value estimated using the Black-Scholes Model.
Common Stock Options
Stock compensation activity under the 2013 Plan for the six months ended March 31, 2023 follows:
Option Shares Outstanding |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (years) |
Aggregate Intrinsic Value |
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Outstanding at September 30, 2022 |
$ | $ | ||||||||||||||
Awarded |
$ | |||||||||||||||
Forfeited/Cancelled |
( |
) |
$ | |||||||||||||
Outstanding at March 31, 2023 |
$ | |||||||||||||||
Vested at March 31, 2023 |
$ | |||||||||||||||
Vested and expected to vest at March 31, 2023 |
$ |
As of March 31, 2023,
Share-based compensation expense recorded in the Company’s Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022 resulting from options awarded to the Company’s employees, directors and consultants was approximately $
During the six months ended March 31, 2023 and 2022, no options awarded were exercised.
As of March 31, 2023, there is approximately $
Restricted Stock
Restricted stock activity under the 2013 Plan for the three months ended March 31, 2023 and 2022, in shares, follows:
Three months Ended |
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March 31, 2023 |
March 31, 2022 |
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Non Vested at December 31, 2022 and 2021 |
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Vested |
( |
) |
( |
) |
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Non Vested at March 31, 2023 and 2022 |
The weighted grant date fair value average of the restricted stock for the three months ended March 31, 2023 and 2022 follows:
Three months Ended |
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March 31, 2023 |
March 31, 2022 |
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Non Vested at December 31, 2022 and 2021 |
$ | $ | ||||||
Vested |
( |
) |
( |
) |
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Non Vested at March 31, 2023 and 2022 |
$ | $ |
Restricted stock activity under the 2013 Plan for the six months ended March 31, 2023 and 2022, in shares, follows:
Six months Ended |
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March 31, 2023 |
March 31, 2022 |
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Non Vested at September 30, 2022 and 2021 |
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Vested |
( |
) |
( |
) |
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Non Vested at March 31, 2023 and 2022 |
The weighted grant date fair value average of the restricted stock for the six months ended March 31, 2023 and 2022 follows:
Six months Ended |
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March 31, 2023 |
March 31, 2022 |
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Non Vested at September 30, 2022 and 2021 |
$ | $ | ||||||
Vested |
( |
) |
( |
) |
||||
Non Vested at March 31, 2023 and 2022 |
$ | $ |
For the three months ended March 31, 2023 and 2022, compensation expense recorded for the restricted stock awards was approximately $
7. REGISTERED DIRECT OFFERINGS
On September 30, 2016, the Company filed a registration statement with the SEC utilizing a “shelf” registration process, which was subsequently declared effective by the SEC on October 20, 2016 (such registration statement, the “Shelf Registration Statement”). Under the Shelf Registration Statement, the Company may offer and sell any combination of its Common Stock, warrants, debt securities, subscription rights, and/or units comprised of the foregoing to raise up to $
On February 20, 2017, the Company entered into a Securities Purchase Agreement (the “2017 SPA”) with six accredited investors (collectively, the “2017 Investors”) providing for the issuance and sale by the Company to the 2017 Investors of an aggregate of
On June 28, 2018, the Company entered into a Securities Purchase Agreement (“2018 SPA”) with
On May 12, 2019, the Company entered into a Securities Purchase Agreement (“2019 SPA”) with
On March 10, 2023, the Company entered into exchange agreements (the “Exchange Agreements”) with each holder (the “Warrantholders”) of the Company’s outstanding Series G Warrants to purchase shares of the Company’s common stock, par value $
8. Derivative Liabilities
The Company accounted for the Series F Warrants, Series G Warrants and the Series H Warrants in accordance with ASC 815-10. Since the Company was required to purchase its Series F Warrants, Series G Warrants and Series H Warrants for an amount of cash equal to $
On the respective closing dates of June 28, 2018 and May 12, 2019, respectively, the derivative liabilities related to the Series G Warrants and Series H Warrants were recorded at an aggregate fair value of $
On March 10, 2023, Arch Therapeutics, Inc. entered into exchange agreements (the “Exchange Agreements”) with each holder (the “Warrantholders”) of the Company’s outstanding Series G Warrants to purchase shares of the Company’s common stock, par value $
During the three months ended March 31, 2023, $
Fair Value Measurements Using Significant Unobservable Inputs – Six Months Ended March 31, 2023 |
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(Level 3) |
Series G |
Series H |
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Beginning balance at September 30, 2022 |
$ | $ | ||||||
Exchange of warrants into common stock |
( |
) |
( |
) |
||||
Extinguishment of derivative liabilities | ( |
) | ( |
) | ||||
Ending balance at March 31, 2023 |
$ | $ |
Fair Value Measurements Using Significant Unobservable Inputs - Six Months Ended March 31, 2022 |
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(Level 3) |
Series F |
Series G |
Series H |
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Beginning balance at September 30, 2021 |
$ | $ | $ | |||||||||
Issuances |
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Adjustments to estimated fair value |
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Expiration of derivative liability | ( |
) | ||||||||||
Ending balance at March 31, 2022 |
$ | $ | $ |
The derivative liabilities as of March 10, 2023 and September 30, 2022 are valued at the greater of their minimum value or by using the Black Scholes Model with the following assumptions.
As of March 10, 2023, the derivative liabilities are recorded at their minimum value. |
Series G |
Series H |
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Closing price per share of Common Stock |
$ | $ | ||||||
Exercise price per share |
$ | $ | ||||||
Expected volatility |
% |
% |
||||||
Risk-free interest rate |
% |
% |
||||||
Dividend yield |
||||||||
Remaining expected term of underlying securities (years) |
As of September 30, 2022, the derivative liabilities are recorded at their minimum value.
Series G |
Series H |
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Closing price per share of Common Stock |
$ | $ | ||||||
Exercise price per share |
$ | $ | ||||||
Expected volatility |
% |
% |
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Risk-free interest rate |
% |
% |
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Dividend yield |
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Remaining expected term of underlying securities (years) |
9. OCTOBER 2019 REGISTERED DIRECT OFFERING
On October 16, 2019, the Company entered into a Securities Purchase Agreement (the “October 2019 SPA”) with
The gross proceeds to the Company from the October 2019 Financing, which were received as of October 18, 2019, were approximately $
The Company engaged H.C. Wainwright as its exclusive institutional investor placement agent (the “Placement Agent”) in connection with the October 2019 SPA pursuant to an engagement agreement dated as of October 10, 2019 (the “2019 Engagement Agreement”). In consideration for the services provided by the Placement Agent, the Placement Agent was entitled to receive cash fees ranging from
During the three and six months ended March 31, 2023 and 2022,
Common Stock
On October 18, 2019, the Closing Date of the October 2019 Financing, the Company issued
Equity Value of Warrants
The Company accounted for the Series I Warrants and the Placement Agent Warrants relating to the aforementioned October 2019 Financing in accordance with ASC 815-40. Because the Series I Warrants and the Placement Agent Warrants are indexed to the Company’s Common Stock, they are classified within stockholders’ deficit in the accompanying consolidated financial statements.
10. 2021 REGISTERED DIRECT OFFERING
On February 11, 2021, the Company entered into a Securities Purchase Agreement (the “2021 SPA”) with certain institutional and accredited investors (collectively, “2021 Investors”) providing for the issuance and sale by the Company to the 2021 Investors of an aggregate of
The 2021 SPA contained certain restrictions on the Company’s ability to conduct subsequent sales of the Company’s equity securities. In particular, we were prohibited from entering into or effecting a Variable Rate Transaction (as defined in the 2021 SPA) until February 11, 2022; provided, however, the Company may enter into and effect an at-the-market offering facility with the Placement Agent.
The number of shares of the Company’s Common Stock into which each of the Series K Warrants is exercisable and the exercise price therefore are subject to adjustment, as set forth in the Series K Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise).
During the three and six months ended March 31, 2023,
Common Stock
On February 17, 2021, the Closing Date of the 2021 Financing, the Company issued
Equity Value of Warrants
The Company accounted for the Series K Warrants and the Placement Agent 2 Warrants relating to the aforementioned February 2021 Registered Direct Offering in accordance with ASC 815-40, Derivatives and Hedging. Because the Series K Warrants and the Placement Agent 2 Warrants are indexed to the Company’s stock, they are classified within stockholders’ deficit in the accompanying consolidated financial statements.
11. 2022 CONVERTIBLE NOTE OFFERING AND SECOND NOTES OFFERING
On July 7, 2022, the Company announced that it had entered into a Securities Purchase Agreement (the “2022 SPA”) with certain institutional and accredited individual investors (collectively, the “2022 Investors”) providing for the issuance and sale by the Company to the 2022 Investors of (i) Senior Secured Convertible Promissory Notes (each a “2022 Note” and collectively, the “2022 Notes”) in the aggregate principal amount of $
On January 18, 2023, the Company entered into Amendment No. 1 to the 2022 SPA (the “Amendment” and, together with the 2022 SPA, the “Amended 2022 SPA”), with certain Investors in connection with the Second Closing of the 2022 Convertible Note Offering for the issuance and sale by the Company to such Investors of an aggregate of (i) Unsecured Convertible Promissory Notes (each a “Second Note” and collectively, the “Second Notes”) in the aggregate principal amount of $
The 2022 Notes and the Second Notes bear interest on the unpaid principal balance at a rate equal to ten percent (
The 2022 Notes and the Second Notes are convertible into shares of Common Stock at the option of each holder of the 2022 Notes and the Second Notes from the date of issuance at $
The 2022 Notes and Second Notes contain customary events of default, which include, among other things, (i) our failure to pay when due any principal or interest payment under the 2022 Notes and Second Notes; (ii) our insolvency; (iii) delisting of our Common Stock; (iv) our breach of any material covenant or other material term or condition under the 2022 Notes and Second Notes; and (v) our breach of any representations or warranties under the 2022 Notes and Second Notes which cannot be cured within five (5) days. Further, events of default under the 2022 Notes and Second 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 Notes and/or Second Notes 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 June 15, 2023 (as amended) (an “Uplist Transaction”).
The 2022 Warrants and the Second Warrants (i) have an exercise price of $
The Company retained a placement agent in connection with the private placement of $
The Company’s agreement with the 2022 Placement Agent was still effective at the time of the private placement of $
In addition, as a part of the 2022 Convertible Note Offering, certain holders of the Company’s
Further, in connection with the 2022 Convertible Note Offering, we initially were required to complete an Uplist Transaction by February 15, 2023 under the terms of the 2022 Notes. If we are unable to complete or secure an extension to the Uplist Transaction deadline, then the 2022 Notes and Second Notes will become immediately due and payable and we will be obligated to pay to each holder of the 2022 Notes and Second Notes an amount equal to
On March 10, 2023, the Company entered into an amendment (“Amendment No. 2 to the First Notes”) with each of the holders of the Company’s outstanding 2022 Notes issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”). On March 10, 2023, the Company also entered into an amendment (“Amendment No. 2 to the Second Notes” and, together with Amendment No. 2 to the First Notes, “Amendment No. 2 to the 2022 Notes”) with each Second Notes issued in connection with a private placement financing the Company completed on January 18, 2023.
Under Amendment No. 2 to the 2022 Notes and Second Notes, the following amendments to the 2022 Notes will be effective at the moment in time immediately preceding the consummation of the offering in connection with the uplist of the Common Stock to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American (the “Uplist Transaction”). If a holder of the 2022 Notes and/or the Second Notes elects to participate in the Uplist Transaction (each, a “Participating Holder”) for an amount equal to no less than 50% of the Participating Holder’s original investment amount in the 2022 Convertible Note Offering, such holder will be entitled to repayment of the principal amount of their 2020 Notes and/or Second Notes upon closing of the Uplist Transaction. In addition, the Company will issue to each Participating Holder a new convertible promissory note equal to the product of
During the three months ended March 31, 2023, the Company recorded interest expense on the 2022 Notes and the Second Notes of approximately $
Allocation of Proceeds
The Company accounted for the 2022 Notes and Second Notes, the 2022 Warrants and the Second Warrants, the 2022 Inducement Shares and Second Inducement Shares relating to the aforementioned 2022 Notes and Second Notes in accordance with ASC 470-20-25-2 “Debt” which states that the allocation of the proceeds from the financing shall be based on the relative fair values of the securities issued at the time of the issuance. The 2022 Inducement Shares and the 2022 Warrants, which are indexed to the Company’s stock, are classified within stockholders’ equity (deficit) in the accompanying consolidated financial statements. The allocated value of the 2022 Inducement Shares and the 2022 Warrants are $
The 2022 Warrants and the 2022 Placement Agent Warrants were valued as of July 6, 2022 using the Black Scholes Model with the following assumptions:
2022 Warrants |
2022 Placement Agent Warrants |
|||||||
Closing price per share of Common Stock |
$ | $ | ||||||
Exercise price per share |
$ | $ | ||||||
Expected volatility |
% |
% |
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Risk-free interest rate |
% |
% |
||||||
Dividend yield |
||||||||
Remaining expected term of underlying securities (years) |
The Second Warrants and the Second Placement Agent Warrants were valued as of January 18, 2023 using the Black Scholes Model with the following assumptions:
Second Warrants |
Second Placement Agent Warrants |
|||||||
Closing price per share of Common Stock |
$ | $ | ||||||
Exercise price per share |
$ | $ | ||||||
Expected volatility |
% |
% |
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Risk-free interest rate |
% |
% |
||||||
Dividend yield |
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Remaining expected term of underlying securities (years) |
12. SERIES CONVERTIBLE NOTES
On June 4, 2020 and November 6, 2020, the Company issued unsecured
Beginning June 22, 2015 and through June 30, 2015, the Company entered into a series of substantially similar subscription agreements with 20 accredited investors providing for the issuance and sale by the Company to the 2015 Investors, in a private placement, of an aggregate of
On June 3, 2020, the Company entered into an agreement (the “Agreement”) with the holders of a majority (the “Majority Holders”) of the outstanding warrants classified as “Series D Warrants”, resulting in approximately $
On June 22, 2020, the Company entered into a Series J Warrant Issuance Agreement (the “Keyes Sulat Agreement”) with the Keyes Sulat Revocable Trust (the “Trust”), also a holder of outstanding Series D Warrants, resulting in approximately $
As described in Note 11 above, as a part of the 2022 Convertible Note Offering, certain holders of the Series 2 Notes agreed to exchange Series 2 Notes with an aggregate principal amount of $
On March 10, 2023, the Company entered into an amendment (the “Series 2 Note Amendment” and, together with the Series 1 Amendment, the “Series Note Amendments”) with each of the holders of the Company’s outstanding Series 2 Convertible Notes (as amended, the “Series 2 Notes” and, together with the Series 1 Notes, the “Series Convertible Notes”). Pursuant to the Series Note Amendments, the Company can elect to convert the principal and accrued interest under the Series Convertible Notes (the “Series Note Obligations”) at or after the effective time of the Uplisting Transaction, or the maturity date. In the event the Company exercises such option, the Series Note Obligations will be deemed to equal the product of
During the three months ended March 31, 2023 and 2022, the Company recorded interest expense on the Series Convertible Notes of approximately $
13. RISKS AND UNCERTAINTIES – COVID-19 AND 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 the COVID-19 or 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, including the recent war in Ukraine. The extent to which the COVID-19 and recent events in Ukraine will impact the global economy and the Company is uncertain and cannot be reasonably measured.
14. SHAREHOLDER ADVANCES
During the three months ended March 31, 2023, the Company raised $
15. SUBSEQUENT EVENTS
On April 15, 2023, Arch Therapeutics, Inc. (the “Company”) entered into an amendment (“Amendment No. 4 to the First Notes”) with the holders of the Company’s outstanding 2022 Notes, as amended on February 14, 2023, March 10, 2023 and March 15, 2023 issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”). On April 15, 2023, the Company also entered into an amendment (“Amendment No. 4 to the Second Notes” and, together with Amendment No. 4 to the First Notes, “Amendment No. 4 to the 2022 Notes”) with the holders of the Company’s outstanding Second Notes, as amended on February 14, 2023, March 10, 2023 and March 15, 2023 issued in connection with a private placement financing the Company completed on January 18, 2023 (the “Second Closing”).
Under Amendment No. 4 to the 2022 Notes, the 2022 Notes and the Second 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”) from April 15, 2023 to May 15, 2023.
As a result of the entry into Amendment No. 4 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 April 15, 2023 to May 15, 2023. Also, on April 15, 2023, in connection with Amendment No. 4 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from April 15, 2023 to May 15, 2023.
On April 15, 2023, the Company entered into an amendment (“Amendment No. 1 to the A&R Registration Rights Agreement”) to that certain Amended and Restated Registration Rights Agreement, dated as of January 18, 2023, by and among the Company and certain institutional and accredited individual investors (as amended, the “A&R Registration Rights Agreement”). Under Amendment No. 1 to the A&R Registration Rights Agreement, the A&R Registration Rights Agreement was amended to extend the filing deadline by which the Company is obligated to file with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended, registering certain securities issued in the Second Closing, from April 18, 2023 to June 17, 2023.
On May 15, 2023, the Company entered into Amendment No. 2 to the 2022 SPA related to the 2022 Convertible Note Offering (the “Amendment” and, together with the 2022 SPA, the “Amended 2022 SPA”), with certain Investors in connection with the Third Closing of the 2022 Convertible Note Offering for the issuance and sale by the Company to an Investor of an aggregate of (i) Unsecured Convertible Promissory Notes (each a “Third Note” and collectively, the “Third Notes”) in the aggregate principal amount of $
On May 15, 2023, the Company entered into an amendment (“Amendment No. 5 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 and April 15, 2023 issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”) to extend the date of the completion of the Uplist Transaction from May 15, 2023 to June 15, 2023.
On May 15, 2023, the Company also entered into an amendment (“Amendment No. 5 to the Second Notes” and, together with Amendment No. 5 to the First Notes, “Amendment No. 5 to the 2022 Notes”) with the holders of the Company’s outstanding Second Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023 and April 15, 2023, issued in connection with a private placement financing the Company completed on January 18, 2023 (the “Second Closing”) to extend the date of the completion of the Uplist Transaction from May 15, 2023 to June 15, 2023.
On May 15, 2023, as a result of the entry into Amendment No. 5 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 May 15, 2023 to June 15, 2023. Also, on May 15, 2023, in connection with Amendment No. 5 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from May 15, 2023 to June 15, 2023.
On May 18, 2023, the Company received an additional advance from a third party of $
Item 2. Management’s 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”, “Arch” or similar references mean Arch Therapeutics, Inc. and its 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 Factors” included 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”) was incorporated under the laws of the State of Nevada on September 16, 2009, under the name “Almah, Inc.”. Effective June 26, 2013, the Company completed a merger (the “Merger”) with Arch Biosurgery, Inc. (formerly known as Arch Therapeutics, Inc.), a Massachusetts corporation (“ABS”), and Arch Acquisition Corporation (“Merger Sub”), the Company’s wholly owned subsidiary formed for the purpose of the transaction, pursuant to which Merger Sub merged with and into ABS and ABS thereby became the wholly owned subsidiary of the Company. As a result of the acquisition of ABS, the Company abandoned its prior business plan and changed its operations to the business of a biotechnology company. Our principal offices are located in Framingham, Massachusetts.
ABS was incorporated under the laws of the Commonwealth of Massachusetts on March 6, 2006, as Clear Nano Solutions, Inc. On April 7, 2008, ABS changed its name from Clear Nano Solutions, Inc. to Arch Therapeutics, Inc. Effective upon the closing of the Merger, ABS changed its name from Arch Therapeutics, Inc. to Arch Biosurgery, Inc.
In the first quarter of 2021, the Company commenced commercial sales of our first product, AC5® Advanced Wound System, and has devoted substantially all of our operational effort to the research, development and regulatory programs necessary to turn our core technology into commercial products. To date, the Company has principally raised capital through debt borrowings, the issuance of convertible debt, and 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 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 stopping bleeding (“hemostasis”), controlling leaking (“sealant”), and managing wounds created during surgery, trauma or interventional care, or from disease. We have only recently commenced commercial sales of our first product, AC5® Advanced Wound System, and have devoted substantially all of our operational effort to the research, development and regulatory programs necessary to turn our core technology into commercial products. Our goal is to make care faster and safer for patients with 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.
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 and Europe, respectively, and which are intended for skin applications, such as the management of complicated chronic wounds and acute surgical wounds. 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 AC5 platform contain a 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 connective tissue and self-assemble 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:
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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. |
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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. |
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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. |
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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 other properties, regardless of the presence of antithrombotic agents, 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 in which there is a wound inside or on the body, and in which there is need for a hemostatic agent or sealant. 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 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.
Operations
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; 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:
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conducting biocompatibility, pre-clinical, and clinical studies on our products and product candidates; |
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obtaining additional marketing authorization for products in the United States, Europe, and other jurisdictions as we may determine; |
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continuing to develop third party relationships to manufacture, distribute, market and otherwise commercialize our products; |
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continuing to develop academic, scientific and institutional relationships to collaborate on product research and development; |
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expanding and maintaining protection of our intellectual property portfolio; and |
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developing additional product candidates in Dermal Sciences, BioSurgery, and other areas. |
In furtherance of our long-term business goals, we expect to continue to focus on the following activities during the next twelve months:
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seek additional funding as required to support the previously described milestones necessary to support operations; |
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work with our manufacturing partners to scale up production of product compliant with current good manufacturing practices (“cGMP”), which activities will be ongoing and tied to our development and commercialization needs; |
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further clinical development of our product platform; |
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assess our technology platform in order to identify and select product candidates for potential advancement into development; |
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seek regulatory input to guide activities related to expanded and new product marketing authorizations; |
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continue to expand and enhance our financial and operational reporting and controls; |
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pursue commercial partnerships; and |
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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, which activities will be ongoing as we seek to expand our product candidate portfolio. |
We have no commitments for any future capital. We will require significant additional financing to fund our planned operations, including further research and development relating to AC5®, seeking regulatory approval of any 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.
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. We could spend our financial resources much faster than we expect, in which case we would need to raise additional capital as our current funds may not be sufficient to operate our business for the entire duration of that period.
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. These third parties include academic institutions, consultants, advisors, scientists, and/or other collaborators. 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 preclinical and clinical testing and ultimately, as required marketing authorizations are obtained, commercialization.
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.
Merger with ABS and Related Activities
On June 26, 2013, the Company completed the Merger with ABS, pursuant to which ABS became a wholly owned subsidiary of the Company. In contemplation of the Merger, effective May 24, 2013, the Company increased its authorized Common Stock, from 375,000 shares to 1,500,000 shares and effected a forward stock split, by way of a stock dividend, of its issued and outstanding shares of Common Stock at a ratio of 11 shares to each 1 issued and outstanding share. Also, in contemplation of the Merger, effective June 5, 2013, the Company changed its name from Almah, Inc. to Arch Therapeutics, Inc. and changed the ticker symbol under which its Common Stock trades on the OTC Bulletin Board from “AACH” to “ARTH”.
Recent Developments
On January 13, 2023, the Company filed a Certificate of Change to the Company’s Articles of Incorporation, as amended, with the Secretary of State of the State of Nevada (the “Certificate of Change”), which effected, at 5:00 p.m. Eastern Time on January 17, 2023, a one-for-two-hundred (1:200) reverse stock split (the “Reverse Stock Split”) of both the Company’s issued and outstanding shares of Common Stock, and authorized shares of Common Stock.
As a result of the Reverse Stock Split, every two hundred (200) shares of Common Stock issued and outstanding was combined into one (1) share of Common Stock, with a proportionate 1:200 reduction in the Company’s authorized Common Stock. The Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the Reverse Stock Split would have resulted in some stockholders owning a fractional share. No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares of Common Stock resulting from the Reverse Stock Split were rounded up to the nearest whole post-Reverse Stock Split share and no stockholders received cash in lieu of fractional shares.
The Reverse Stock Split did not change the par value of the Common Stock. All outstanding securities entitling their holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock units, and warrants, were adjusted as a result of the Reverse Stock Split, as required by the terms of those securities.
On January 13, 2023, the Company filed a Certificate of Amendment (the “Certificate of Amendment”) to the Company’s Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Nevada to increase the number of authorized shares of Common stock from 4,000,000 shares to 12,000,000 shares. The increase in the number of authorized shares was approved by the Company’s stockholders on September 29, 2022.
As previously disclosed in footnote 11 in this Form 10-Q, the Company entered into a Securities Purchase Agreement, dated July 6, 2022 (“SPA”), with certain institutional and accredited individual investors (collectively, the “Investors”) for the issuance and sale by the Company to the Investors of convertible promissory notes, warrants to purchase shares of common stock, par value $0.001 per share (the “Common Stock”), and shares of Common Stock (the “2022 Convertible Note Offering”). The First Closing of the 2022 Convertible Note Offering occurred on July 6, 2022.
On January 18, 2023, the Company entered into Amendment No. 1 to the 2022 SPA (the “Amendment” and, together with the SPA, the “Amended 2022 SPA”), with certain Investors in connection with the second closing of the 2022 Convertible Note Offering for the issuance and sale by the Company to such Investors of an aggregate of (i) Unsecured Convertible Promissory Notes (each a “Second Note” and collectively, the “Second Notes”) in the aggregate principal amount of $636,000, which includes an aggregate $106,000 original issue discount in respect of the Second Notes; (ii) warrants (the “Second Warrants”) to purchase an aggregate of 127,968 shares (the “Second Warrant Shares”) of Common Stock; and (iii) 9,598 shares of Common Stock (the “Second Inducement Shares”). The aggregate gross proceeds for the sale of the Second Notes, Second Warrants and Second Inducement Shares was approximately $530,000, before deducting any placement agent’s fees and other estimated fees and offering expenses payable by the Company. The second closing of the sales of these securities under the Amended SPA occurred on January 18, 2023 (the “Second Closing Date”).
On February 14, 2023, the Company entered into an amendment to its outstanding 2022 Notes issued on July 6, 2022 with the holders of such notes. Also on February 14, 2023, the Company entered into an amendment to its outstanding Second Notes issued on January 18, 2023 with the holders of such notes. These actions amended the 2022 Notes and Second Notes to extend the Uplist Transaction deadline related to the Company’s efforts to uplist to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American from February 15, 2023 to March 15, 2023.
As a result of the amendment to the 2022 Notes and Second 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 February 15, 2023 to March 15, 2023.
On March 10, 2023, the Company entered into exchange agreements (the “Exchange Agreements”) with each holder (the “Warrantholders”) of the Company’s outstanding Series G Warrants to purchase shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”) at an exercise price of $140.00 per share and the Company’s outstanding Series H Warrants to purchase shares of Common Stock at an exercise price of $80.00 per share. Pursuant to the Exchange Agreements, the Warrantholders exchanged 34,013 Series G Warrants for 3,402 shares of Common Stock and 43,077 Series H Warrants for 8,617 shares of Common Stock.
On March 10, 2023, the Company entered into an amendment (“Amendment No. 2 to the First Notes”) with the Requisite Holders of the Company’s outstanding 2022 Notes, as amended on February 14, 2023 issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”). On March 10, 2023, the Company also entered into an amendment (“Amendment No. 2 to the Second Notes” and, together with Amendment No. 2 to the First Notes, “Amendment No. 2 to the 2022 Notes”) with the Requisite Holders of Company’s Second Notes, as amended on February 14, 2023, issued in connection with a private placement financing the Company completed on January 18, 2023 (the “Second Closing” and, together with the First Closing, the “2022 Convertible Note Offering”).
On March 15, 2023, the Company entered into amendments to the 2022 Notes (“Amendment No. 3 to the First Notes”) and Second Notes (“Amendment No. 3 to the Second Notes” and collectively, “Amendment No. 3 to the 2022 Notes” and, together with Amendment No. 2 to the 2022 Notes, the “Amendments to the 2022 Notes”) with the Requisite Holders of the 2022 Notes and Second Notes. Under Amendment No. 3 to the 2022 Notes, the 2022 Notes were amended to extend the Amendment No. 2 Termination Date from March 15, 2023 to April 15, 2023, which had the effect of extending to Uplist Transaction deadline from March 15, 2023 to April 15, 2023. In connection with Amendment No. 3 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from March 15, 2023 to April 15, 2023.
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 (i) extend the Amendment No. 2 Termination Date from March 15, 2023 to April 15, 2023; (ii) modify the terms of the Uplist Transaction repayment provision; and (iii) provide for the issuance of the 2023 Notes, subject to completion of the Uplist Transaction.
Also, on March 15, 2023, in connection with Amendment No. 3 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from March 15, 2023 to April 15, 2023.
On April 15, 2023, the Company entered into an amendment (“Amendment No. 4 to the First Notes”) with the holders of the Company’s outstanding 2022 Notes, as amended on February 14, 2023, March 10, 2023 and March 15, 2023, issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”). On April 15, 2023, the Company also entered into an amendment (“Amendment No. 4 to the Second Notes” and, together with Amendment No. 4 to the First Notes, “Amendment No. 4 to the 2022 Notes”) with the holders of the Company’s outstanding Second Notes, as amended on February 14, 2023, March 10, 2023 and March 15, 2023 issued in connection with a private placement financing the Company completed on January 18, 2023 (the “Second Closing”).
Under Amendment No. 4 to the 2022 Notes, the 2022 Notes and Second 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”) from April 15, 2023 to May 15, 2023.
As a result of the entry into Amendment No. 4 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 April 15, 2023 to May 15, 2023. Also, on April 15, 2023, in connection with Amendment No. 4 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from April 15, 2023 to May 15, 2023.
On April 15, 2023, the Company entered into an amendment (“Amendment No. 1 to the A&R Registration Rights Agreement”) to that certain Amended and Restated Registration Rights Agreement, dated as of January 18, 2023, by and among the Company and certain institutional and accredited individual investors (as amended, the “A&R Registration Rights Agreement”). Under Amendment No. 1 to the A&R Registration Rights Agreement, the A&R Registration Rights Agreement was amended to extend the filing deadline by which the Company is obligated to file with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended, registering certain securities issued in the Second Closing, from April 18, 2023 to June 17, 2023.
On May 15, 2023, the Company entered into Amendment No. 2 to the 2022 SPA related to the 2022 Convertible Note Offering (the “Amendment” and, together with the 2022 SPA, the “Amended 2022 SPA”), with certain Investors in connection with the third closing of the 2022 Convertible Note Offering for the issuance and sale by the Company to an Investor of an aggregate of (i) Unsecured Convertible Promissory Notes (each a “Third Note” and collectively, the “Third Notes”) in the aggregate principal amount of $702,720, which includes an aggregate $214,720 original issue discount in respect of the Third Notes; (ii) warrants (the “Third Warrants”) to purchase an aggregate of 141,396 shares (the “Third Warrant Shares”) of Common Stock; and (iii) 10,608 shares of Common Stock (the “Third Inducement Shares”). The aggregate gross proceeds for the sale of the Third Notes, Third Warrants and Third Inducement Shares was approximately $488,000, before deducting the placement agent’s fees and other estimated fees and offering expenses payable by the Company. The third closing of the sales of these securities under the Amended SPA occurred on May 15, 2023 (the “Third Closing Date”).
On May 15, 2023, the Company entered into an amendment (“Amendment No. 5 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 and April 15, 2023, issued in connection with a private placement financing the Company completed on July 6, 2022 (the “First Closing”) to extend the date of the completion of the Uplist Transaction from May 15, 2023 to June 15, 2023. In connection with Amendment No. 5 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from May 15, 2023 to June 15, 2023.
On May 15, 2023, the Company also entered into an amendment (“Amendment No. 5 to the Second Notes” and, together with Amendment No. 5 to the First Notes, “Amendment No. 5 to the 2022 Notes”) with the holders of the Company’s outstanding Second Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023 and April 15, 2023 issued in connection with a private placement financing the Company completed on January 18, 2023 (the “Second Closing”) to extend the date of the completion of the Uplist Transaction from May 15, 2023 to June 15, 2023.
As a result of the entry into Amendment No. 5 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 May 15, 2023 to June 15, 2023. Also, on May 15, 2023, in connection with Amendment No. 5 to the 2022 Notes, the Series Note Amendments Termination Date set forth under Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from May 15, 2023 to June 15, 2023.
On May 18, 2023, the Company received an additional advance from a third party of $350,000, which is expected to be rolled into an anticipated near-term capital raise not related to the prior 2022 Convertible Note Offering.
Results of Operations
The following discussion of our results of operations should be read together with the unaudited interim consolidated financial statements included in this Report. The period-to-period comparisons of our interim results of operations that follow are not necessarily indicative of future results.
Three Months Ended March 31, 2023 Compared to Three Months Ended March 31, 2022
March 31, |
March 31, |
Increase |
||||||||||
2023 |
2022 |
(Decrease) |
||||||||||
($) |
($) |
($) |
||||||||||
Revenue |
16,654 | 3,130 | 13,524 | |||||||||
Operating Expense: |
||||||||||||
Cost of revenues |
18,718 | 17,430 | 1,288 | |||||||||
Selling, general and administrative |
1,252,786 | 1,208,910 | 43,876 | |||||||||
Research and development |
170,634 | 527,656 | (357,022 |
) |
||||||||
Loss from Operations |
(1,425,484 |
) |
(1,750,866 |
) |
(325,382 |
) |
||||||
Other Income |
523,007 | 960,548 | (437,541 |
) |
||||||||
Net loss |
(902,477 |
) |
(790,318 |
) |
112,159 |
Revenue
Revenue for the three months ended March 31, 2023 was $16,654, an increase of $13,524 compared to revenue of $3,130 for the three months ended March 31, 2022. Revenue for the three months ended March 31, 2023 and 2022 was the result of transactions into VA Hospitals through our distribution partner, Lovell Government Services (“LGS”).
Cost of Revenue
Cost of revenue during the three months ended March 31, 2023 was $18,718, an increase of $1,288 compared to cost of revenue of $17,430 for the three months ended March 31, 2022. Cost of revenue includes product costs, third party warehousing, overhead allocation, royalty and shipping costs.
Selling, General and Administrative Expense
Selling, general and administrative expense during the three months ended March 31, 2023 was $1,252,786, an increase of $43,876 compared to $1,208,910 for the three months ended March 31, 2022. The increase in selling, general and administrative expense for the three months ended March 31, 2023 is primarily attributable to an increase in consulting cost.
Research and Development Expense
Research and development expense during the three months ended March 31, 2023 was $170,634 a decrease of $357,022 compared to $527,656 for the three months ended March 31, 2022. The decrease in research and development expense is primarily attributable to a decrease in compensation costs attributed to a reduction in headcount.
Other (Expense) Income
Other income during the three months ended March 31, 2023 was $523,007, a decrease of $437,541 compared to other income of $960,548 for the three months ended March 31, 2022. The decrease in other income is primarily attributed to an increase in interest expense related to the 2022 Notes and Second Notes offset by a gain for the extinguishment of the Series G warrants and Series H warrants derivative liabilities during the three months ended March 31, 2023 and the impact of the expiration of the Series F warrants during the three months ended March 31, 2022.
Six Months Ended March 31, 2023 Compared to Six Months Ended March 31, 2022
March 31, |
March 31, |
Increase |
||||||||||
2023 |
2022 |
(Decrease) |
||||||||||
($) |
($) |
($) |
||||||||||
Revenue |
22,914 | 7,826 | 15,088 | |||||||||
Operating Expense: |
||||||||||||
Cost of revenues |
36,353 | 34,223 | 2,130 | |||||||||
Selling, general and administrative |
2,355,701 | 2,472,013 | (116,312 |
) |
||||||||
Research and development |
332,087 | 762,274 | (430,187 |
) |
||||||||
Loss from Operations |
(2,701,227 |
) |
(3,260,684 |
) |
559,457 | |||||||
Other (Expense) Income |
(1,306 |
) |
920,219 | 921,525 | ||||||||
Net loss |
(2,702,533 |
) |
(2,340,465 |
) |
362,068 |
Revenue
Revenue for the six months ended March 31, 2023 was $22,914, an increase of $15,088 compared to revenue of $7,826 for the six months ended March 31, 2022. Revenue for the six months ended March 31, 2023 and 2022 was primarily the result of transactions into VA Hospitals through our distribution partner, LGS.
Cost of Revenue
Cost of revenue during the six months ended March 31, 2023 was $36,353, an increase of $2,130 compared to cost of revenue of $34,223 for the six months ended March 31, 2022. Cost of revenue includes product costs, third party warehousing, overhead allocation, royalty and shipping costs.
Selling, General and Administrative Expense
Selling, general and administrative expense during the six months ended March 31, 2023 was $2,355,701, a decrease of $116,312 compared to $2,472,013 for the six months ended March 31, 2022. The decrease in selling, general and administrative expense for the six months ended March 31, 2023 is primarily attributable to a decrease in compensation costs attributed to a reduction in headcount partially offset by an increase in consulting costs.
Research and Development Expense
Research and development expense during the six months ended March 31, 2023 was $332,087 a decrease of $430,187 compared to $762,274 for the six months ended March 31, 2022. The decrease in research and development expense is primarily attributable to a decrease in compensation costs attributed to a reduction in headcount.
Other (Expense) Income
Other expense during the six months ended March 31, 2023 was $1,306 an increase of $921,525 compared to other income of $920,219 for the six months ended March 31, 2022. The increase in other (expense) income is primarily attributed to an increase in interest expense related to the 2022 Notes and Second Notes offset by a gain for the extinguishment of the Series G warrants and Series H warrants derivative liabilities during the three months ended March 31, 2023 and the impact of the expiration of the Series F warrants during the three months ended March 31, 2022.
Liquidity and Capital Resources
In the first 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 borrowings and the issuance of convertible debt and units consisting of Common Stock and warrants to fund our operations.
Working Capital
At March 31, 2023, we had total current assets of $1,588,228 (including cash of $29,495) and working capital deficit of $6,390,589. Our working capital as of March 31, 2023 and September 30, 2022 are summarized as follows:
March 31, |
September 30, |
|||||||
2023 |
2022 |
|||||||
Total Current Assets |
$ | 1,588,228 | $ | 2,598,195 | ||||
Total Current Liabilities |
7,978,817 | 3,320,494 | ||||||
Working Capital deficit |
$ | (6,390,589 |
) |
$ | (722,299 |
) |
Total current assets as of March 31, 2023 were $1,588,228, a decrease of $1,009,967 compared to $2,598,195 as of September 30, 2022. The decrease in current assets is primarily attributable to selling, general and administrative expense and research and development expense incurred in connection with activities to develop our primary product candidate. Our total current assets as of March 31, 2023 and September 30, 2022 were comprised primarily of cash, inventory and prepaid expenses and other current assets.
Total current liabilities as of March 31, 2023 were $7,978,817, an increase of $4,658,323 compared to $3,320,494 as of September 30, 2022. The increase is primarily due to an increase in accounts payable, the current portion of the Series 2 Convertible Notes, the current portion of the 2022 Notes, current portion of the Unsecured convertible notes, which includes both the Second Notes and the Exchanged Notes, and the accrued interest associated with these notes partially offset by a decrease to the amount owed in connection with the financing of certain insurance premiums and the decrease in the fair value of the derivative liability resulting from the exchange of the Series G warrants into common stock.
Cash Flow for the Six months Ended March 31, 2023 Compared to the Six Months Ended March 31, 2022
March 31, |
March 31, |
|||||||
2023 |
2022 |
|||||||
Cash Used in Operating Activities |
$ | (1,249,931 |
) |
$ | (2,212,234 |
) |
||
Cash Provided by Financing Activities |
532,486 | - | ||||||
Net decrease in Cash |
$ | (717,445 |
) |
$ | (2,212,234 |
) |
Cash Used in Operating Activities
Cash used in operating activities decreased by $962,303 to $1,249,931 during the six months ended March 31, 2023, compared to $2,212,234 during the six months ended March 31, 2022. The decrease in cash used in operating activities is primarily attributable the Company managing expenses and an increase in accounts payable and accrued interest.
Cash Used in Financing Activities
Cash provided by financing activities increased by $532,486 during the six months ended March 31, 2023, compared to no cash used in financing activities during the six months ended March 31, 2022. For the six months ended March 31, 2023, the cash provided by financing activities was attributable to the Second Closing of 2022 Convertible Note Offering and shareholder advances, which was partially offset by payments made in connection with the financing of certain insurance premiums.
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 2018 SPA (see Note 7) and the 2022 SPA (see Note 12) 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.
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
We have commenced commercial sales of our first product, AC5® Advanced Wound System. From inception, we have had recurring losses from operations. The continuation of our business as a going concern is dependent upon raising additional capital and eventually attaining and maintaining profitable operations. As of March 31, 2023, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements included in this Annual Report do not include any adjustments that might be necessary should operations discontinue.
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:
Inventories
Inventories are stated at the lower of cost or net realizable value. 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 cost of raw materials, work-in-progress and finished goods and other products are determined on a First in First out (FiFo) basis. When determining net realizable value, appropriate consideration is given to obsolescence, excessive levels, deterioration, and other factors in evaluating net realizable value.
Complex Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates its financial instruments, including warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. The Company values its derivatives using the Black-Scholes option-pricing model or other acceptable valuation models, including Monte-Carlo simulations. Derivative instruments are valued at inception, upon events such as an exercise of the underlying financial instrument, and at subsequent reporting periods. The classification of derivative instruments, including whether such instruments should be recorded as liabilities, is re-assessed at the end of each reporting period.
The Company reviews the terms of debt instruments, equity instruments, and other financing arrangements to determine whether there are embedded derivative features, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument. Additionally, in connection with the issuance of financing instruments, the Company may issue freestanding options and warrants, including options or warrants to non-employees in exchange for consulting or other services performed.
The Company accounts for its common stock warrants in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”). Based upon the provisions of ASC 815, the Company accounts for common stock warrants as liabilities if the warrant requires net cash settlement or gives the holder the option of net cash settlement, or it fails the equity classification criteria. The Company accounts for common stock warrants as equity if the contract requires physical settlement or net physical settlement or if the Company has the option of physical settlement or net physical settlement and the warrants meet the requirements to be classified as equity. Common stock warrants classified as liabilities are initially recorded at fair value on the grant date and remeasured at fair value each balance sheet date with the offset adjustments recorded in change in fair value of warrant liability within the consolidated statements of operations. Common stock warrants classified as equity are initially measured at fair value on the grant date and are not subsequently remeasured.
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 Control — Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations (“COSO”). We believe, that as of September 30, 2022.there existed a material weakness in our internal control over financial reporting. The deficiencies in the design of internal control over financial reporting related to a lack of sufficient resources with an understanding of the technical guidance under generally accepted accounting principles related to accounting for complex financial instruments within the 2022 Notes and certain accounting practices relating to the recording of the insurance premium advanced by a third party. Accordingly, the Audit Committee in consultation with management has determined that these matters may be best addressed by: (i) reviewing accounting literature and other technical materials to ensure that the appropriate personnel have a full awareness and understanding of the applicable accounting pronouncements and how they are to be implemented; (ii) additional education on new and existing accounting pronouncements and their application and (iii) requiring senior accounting staff and outside consultants with technical accounting experience to review complex transactions to evaluate and approve the accounting treatment of such transactions. Accordingly, the Board has recommended to management and management has agreed that the Company’s accounting staff, including its Chief Financial Officer, undertake additional training on an accelerated basis and that such training, in view of the complexity of certain generally accepted accounting principles and other matters be ongoing and engage third party specialists on an as-needed basis to help supplement the Company’s internal resources. During the quarter ended March 31, 2023 the Company engaged in active discussions with outside consultants with technical accounting expertise to review complex transactions and to evaluate the accounting treatment of such transactions. The parties remain in discussion to undertake a formal engagement which it expects to execute prior to the completion of the quarter ending June 30, 2023.
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 March 31, 2023, 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.
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
On July 8, 2022, we entered into a Securities Purchase Agreement, dated July 6, 2022 (“2022 SPA”), with certain institutional and accredited individual investors (collectively, the “Investors”) for the issuance and sale by us to the Investors of convertible promissory notes, warrants to purchase shares of common stock, and shares of common stock (the “2022 Convertible Note Offering”). The first closing of the 2022 Convertible Note Offering occurred on July 6, 2022. The Second Closing of the 2022 Convertible Note Offering occurred on January 18, 2023.
On May 15, 2023, we entered into Amendment No. 2 to the 2022 SPA (the “Amendment” and, together with the 2022 SPA, the “Amended 2022 SPA”), with an Investor in connection with the third closing of the 2022 Convertible Note Offering for the issuance and sale by us to such Investors of an aggregate of (i) Unsecured Convertible Promissory Notes (each a “Third Note” and collectively, the “Third Notes”) in the aggregate principal amount of $702,720, which includes an aggregate $214,720 original issue discount in respect of the Third Notes; (ii) warrants (the “Third Warrants”) to purchase an aggregate of 141,396 shares (the “Third Warrant Shares”) of common stock; and (iii) 10,608 shares of common stock (the “Third Inducement Shares”). The aggregate gross proceeds for the sale of the Third Notes, Third Warrants and Third Inducement Shares was approximately $488,000 before deducting the estimated fees and offering expenses payable by us. The third closing of the sales of these securities under the Amended SPA occurred on May 15, 2023 (the “Third Closing Date”).
Use of Proceeds
The net proceeds to us from the Third Closing of the 2022 Convertible Note Offering, after deducting our estimated fees and offering expenses and excluding the proceeds, if any, from the conversion of the Third Notes and the exercise of the Third Warrants, was approximately $488,000. We intend to use the net proceeds from the Third Closing of the 2022 Convertible Note Offering primarily for working capital and general corporate purposes, and we have not allocated specific amounts for any specific purposes.
Third Notes
The Third Notes become due and payable on January 6, 2024 (the “Maturity Date”) 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 Third 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 Third 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 Third Closing Date until the Third 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 Third Notes. Any amount of principal or interest on the Third 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 “Default Interest”).
The Third Notes are convertible into an aggregate of 76,884 shares of common stock (such shares of common stock, the “Conversion Shares”) at the option of each holder of the Third Notes from the Third Closing Date at the Conversion Price (as defined below) through the later of (i) the Maturity Date and (ii) the date of payment of the Default Amount (as defined in the Third Note); provided, however, certain Third 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 our 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 common stock (the “Notes Ownership Limitation”) immediately after giving effect to the Conversion; and provided further, the holder, upon notice to us, 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 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 Third 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 we fail to deliver the shares of common stock issuable upon a conversion by the Deadline (as defined in the Third Notes), then we are obligated to pay such Third Note holder $5,000 per day in cash for each day beyond the Deadline.
The Third Notes contain customary events of default, which include, among other things, (i) our failure to pay when due any principal or interest payment under the Third Notes; (ii) the insolvency of the Company; (iii) delisting of our common stock; (iv) our breach of any material covenant or other material term or condition under the Third Notes; and (v) our breach of any representations or warrants under the Third Notes which cannot be cured within five (5) days. Further, events of default under the Third Notes also include (i) the unavailability of Rule 144 on or after six (6) months after each Third Note’s issuance date; (ii) our failure to deliver the shares of common stock to the Third Note holder upon exercise by such holder of its conversion rights under the Third Note; (iii) our loss of the “bid” price for our common stock and/or a market and such loss is not cured during the specified cure periods; and (iv) our failure to complete an uplist to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American by June 15, 2023 (an “Uplist Transaction”).
Upon an event of default, the Third Notes shall become immediately due and payable and we shall pay to each Third Note holder an amount equal to 125% (the “Default Premium”) multiplied by the sum of the outstanding principal amount of the Third Notes plus any accrued and unpaid interest on the unpaid principal amount of the Third Notes to the date of payment, plus any Default Interest and any other amounts owed to the Holder under the Amended SPA (the “Default Amount”); provided that, upon any subsequent event of default not in connection with the first event of default, such holder shall be entitled to an additional five percent (5%) to the Default Premium for each subsequent event of default. At the election of each Third Note holder, the Default Amount may be paid in cash or shares of common stock equal to the Default Amount divided by the Conversion Price at the time of payment.
Third Warrants
The Third 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 Third Warrant if, as a result of the exercise of the Third Warrant, the holder, together with its affiliates and any other persons whose beneficial ownership of 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 common stock (the “Warrant Ownership Limitation”) immediately after giving effect to the exercise of the Third Warrant. The holder, upon notice to us, 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 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 Third Warrants is exercisable and the exercise price therefor are subject to adjustment as set forth in the Third Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise).
Second Amended and Restated Registration Rights Agreement
On May 15, 2023, we entered into an amendment (the “Second A&R Registration Rights Agreement”) to that certain Amended and Restated Registration Rights Agreement, dated as of January 18, 2023, as amended on April 15, 2023, by and among us and certain institutional and accredited individual investors (as amended, the “A&R Registration Rights Agreement”). Under the Second 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 in the Third Closing.
Note Modification Agreements
On May 15, 2023, we entered into an amendment (“Amendment No. 5 to the First Notes”) with the holders of our outstanding 2022 Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023 and April 15, 2023, issued in connection with a private placement financing completed on July 6, 2022 (the “First Closing”). On May 15, 2023, we also entered into an amendment (“Amendment No. 5 to the Second Notes” and, together with Amendment No. 5 to the First Notes, “Amendment No. 5 to the 2022 Notes”) with the holders of our outstanding Second Notes, as amended on February 14, 2023, March 10, 2023, March 15, 2023 and April 15, 2023, issued in connection with a private placement financing completed on January 18, 2023 (the “Second Closing”).
Under Amendment No. 5 to the 2022 Notes, the 2022 Notes and Second Notes were amended to extend the date of the completion of the Uplist Transaction from May 15, 2023 to June 15, 2023. As a result of the entry into Amendment No. 5 to the 2022 Notes, and pursuant to the terms of our outstanding Exchanged Notes, the Exchanged Notes were automatically amended to extend the date of completion of an Uplist Transaction from May 15, 2023 to June 15, 2023. In addition, as a result of Amendment No. 5 to the 2022 Notes, each of the First Note Amendment Termination Date set forth in the 2022 Notes, the Second Note Amendment Termination Date set forth in the Second Notes, and the Series Note Amendments Termination Date set forth Amendment No. 1 to the Series 1 Unsecured Convertible Promissory Notes and Amendment No. 1 of the Series 2 Unsecured Convertible Promissory Notes was automatically extended from May 15, 2023 to June 15, 2023.
Certain Restrictions on Activities
The Amended SPA contains certain restrictions on our ability to conduct subsequent sales of its equity securities and certain business activities. In particular, commencing on the Third Closing Date and until (A) the payment of the Third Notes in full, or full conversion of the Third Notes, and (B) exercise of the Third Warrants in full, we will be prohibited from (i) changing the nature of business, (ii) selling, divesting, acquiring, or changing the structure of any material assets other than in the ordinary course of business; or (iii) negotiating or entering into any variable rate debt transactions that does not contain a floor price that is more than 50% of the closing price of the common stock on the trading day immediately prior to the Third Closing Date; in each instance without each Third Warrant holder’s prior written consent, which shall not be unreasonably withheld.
The issuance and sale of the Third Notes, Conversion Shares, Third Warrants, Warrant Shares, and Inducement Shares (collectively, the “Securities”) has not been, and upon issuance was not, registered under the Securities Act, and the Securities may not be offered or sold in the United States absent registration under or exemption from the Securities Act and any applicable state securities laws. The Securities will be issued and sold in reliance upon an exemption from registration afforded by Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated under the Securities Act based on the following facts: each of the applicable Investors has represented that it is an accredited investor as defined in Rule 501 promulgated under the Securities Act; that it is acquiring the Securities for its own account and not with a view towards, or for resale in connection with, the public sale or distribution thereof in violation of applicable securities; we used no advertising or general solicitation in connection with the issuance and sale of the Securities to the applicable Investors; and the Securities will be issued as restricted securities.
Receipt of Additional Shareholder Advance
On May 18, 2023, the Company received an additional advance from a third party of $350,000, which is expected to be rolled into an anticipated near-term capital raise not related to the prior 2022 Convertible Note Offering.
Item 6. Exhibits
Incorporated by Reference |
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Exhibit |
Exhibit Title |
Filed Herewith |
Form |
Exhibit No. |
File No. |
Filing Date |
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|
|
|
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Form of Amendment No.2 to Securities Purchase Agreement* |
X | ||||||
Form of Third Note |
X |
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Form of Third Warrant |
X |
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Form of Second A&R Registration Rights Agreement |
X | ||||||
Form of Amendment No. 5 to the First Notes |
X | ||||||
Form of Amendment No. 5 to the Second Notes |
X | ||||||
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 |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit 101) |
* Pursuant to Item 601(b)(10) of Regulation S-K, certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Further, the schedules and exhibits to this agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.
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. |
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Date: May 22, 2023 |
By: |
/s/ TERRENCE W. NORCHI, MD |
Terrence W. Norchi, MD |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: May 22, 2023 |
By: |
/s/ MICHAEL S. ABRAMS |
Michael S. Abrams |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |