NUO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three Months ended March 31, 2022 |
|
|
Three Months ended March 31, 2021 |
|
Revenue |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
- |
|
|
$ |
- |
|
Total revenue |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Costs of sales |
|
|
- |
|
|
|
- |
|
Gross profit (loss) |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
521,818 |
|
|
|
5,721 |
|
Total operating expenses |
|
|
521,818 |
|
|
|
5,721 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(521,818 |
) |
|
|
(5,721 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
- |
|
|
|
- |
|
Other income |
|
|
146,438 |
|
|
|
- |
|
Total other income |
|
|
146,438 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(375,380 |
) |
|
$ |
(5,721 |
) |
|
|
|
|
|
|
|
|
|
Loss per common share |
|
|
|
|
|
Basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
|
|
|
Basic and diluted |
|
|
37,124,205 |
|
|
|
30,258,744 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
NUO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
For the Three Months Ended March 31, 2022 and 2021
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Amount (par $0.0001) |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Stockholders' Equity |
|
Balance, January 1, 2022 |
|
|
37,124,205 |
|
|
$ |
3,713 |
|
|
$ |
24,382,195 |
|
|
$ |
(23,593,069 |
) |
|
$ |
792,839 |
|
Issuance of options to settle related party compensation liabilities |
|
|
- |
|
|
|
- |
|
|
|
103,333 |
|
|
|
- |
|
|
|
103,333 |
|
Stock compensation expense |
|
|
|
|
|
|
|
|
|
|
6,430 |
|
|
|
|
|
|
|
6,430 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(375,380 |
) |
|
|
(375,380 |
) |
Balance, March 31, 2022 |
|
|
37,124,205 |
|
|
$ |
3,713 |
|
|
$ |
24,491,958 |
|
|
$ |
(23,968,449 |
) |
|
$ |
527,222 |
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Amount (par $0.0001) |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Stockholders’ Equity (Deficit) |
|
Balance, January 1, 2021 |
|
|
30,258,744 |
|
|
$ |
3,026 |
|
|
$ |
22,995,854 |
|
|
$ |
(23,502,399 |
) |
|
$ |
(503,519 |
) |
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,721 |
) |
|
|
(5,721 |
) |
Balance, March 31, 2021 |
|
|
30,258,744 |
|
|
$ |
3,026 |
|
|
$ |
22,995,854 |
|
|
$ |
(23,508,120 |
) |
|
$ |
(509,240 |
) |
See accompanying notes to unaudited condensed consolidated financial statements.
NUO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(375,380 |
) |
|
$ |
(5,721 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
6,430 |
|
|
|
- |
|
Gain on settlement of accounts payable |
|
|
(146,438 |
) |
|
|
- |
|
Amortization of operating lease right of use assets |
|
|
5,289 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Other receivables |
|
|
(64,000 |
) |
|
|
- |
|
Inventory, net |
|
|
(94,642 |
) |
|
|
- |
|
Prepaid expenses and other current assets |
|
|
(86,947 |
) |
|
|
- |
|
Accounts payable |
|
|
43,674 |
|
|
|
1,553 |
|
Accrued liabilities |
|
|
(12,061 |
) |
|
|
- |
|
Operating lease liabilities |
|
|
(13,255 |
) |
|
|
- |
|
Net cash used in operating activities |
|
|
(737,330 |
) |
|
|
(4,168 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(11,848 |
) |
|
|
- |
|
Net cash used in investing activities |
|
|
(11,848 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(749,178 |
) |
|
|
(4,168 |
) |
Cash and cash equivalents, beginning of period |
|
|
1,414,569 |
|
|
|
161,432 |
|
Cash and cash equivalents, end of period |
|
$ |
665,391 |
|
|
$ |
157,264 |
|
|
|
|
|
|
|
|
|
|
Supplemental information |
|
|
|
|
|
|
|
|
Cash paid during the period for: |
|
|
|
|
|
|
|
|
Interest expense |
|
$ |
- |
|
|
$ |
- |
|
Income taxes |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing transactions |
|
|
|
|
|
|
|
|
Issuance of options to settle accrued compensation liabilities |
|
$ |
103,333 |
|
|
$ |
- |
|
ROU assets and lease liabilities established at inception of lease |
|
$ |
89,312 |
|
|
$ |
- |
|
See accompanying notes to unaudited condensed consolidated financial statements.
NUO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1 – Description of Business
Description of Business
Nuo Therapeutics, Inc. (“Nuo Therapeutics,” the “Company,” “we,” “us,” or “our”) is a Delaware corporation organized in 1998 under the name Informatix Holdings, Inc. In 1999, Autologous Wound Therapy, Inc., an Arkansas Corporation, merged with and into Informatix Holdings, Inc. and the name of the surviving corporation was changed to Autologous Wound Therapy, Inc. In 2000, Autologous Wound Therapy, Inc. changed its name to Cytomedix, Inc. (“Cytomedix”). In 2001, Cytomedix, filed for bankruptcy under Chapter 11 of the United States Bankruptcy Code, after which Cytomedix was authorized to continue to conduct its business as a debtor and debtor-in-possession. Cytomedix emerged from bankruptcy in 2002 under a Plan of Reorganization. In September 2007, Cytomedix received 510(k) clearance for the Aurix System (“Aurix”), formerly known as the AutoloGel™ System, from the U. S. Food and Drug Administration (“FDA”). In April 2010, Cytomedix acquired the Angel Whole Blood Separation System (“Angel”) and the Angel Business, from Sorin Group USA, Inc. In February 2012, Cytomedix, acquired Aldagen, Inc. (“Aldagen”), a privately held developmental cell-therapy company located in Durham, NC. In 2014, Cytomedix changed its name to Nuo Therapeutics, Inc. In 2016, Nuo filed for and emerged from bankruptcy under Chapter 11. Effective May 1, 2019, we furloughed our remaining employees and ceased standard operational activities as we awaited developments concerning our reconsideration request with the Centers for Medicare & Medicaid Services (“CMS”) regarding Medicare coverage for Aurix. Based on a favorable National Coverage Determination issued in April 2021, we initiated restart activities for the business beginning in October 2021 with an expectation that the Aurix product will be available for commercial sale by May 2022. Aldagen is a non-operational, wholly owned subsidiary of Nuo.
Impact of COVID-19 Pandemic on Financial Statements
On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a “pandemic”, or a worldwide spread of a new disease. Many countries imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses.
The extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the pandemic. The unaudited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The Company has not experienced any significant negative impact on its March 31, 2022 unaudited consolidated financial statements related to COVID-19.
Note 2 –Recapitalization
In anticipation of returning to operational status, the Company undertook several financing transactions during 2019 - 2021 to stabilize its financial condition, as follows:
2018 Convertible Notes
In September 2018, the Company issued two separate convertible notes (the “2018 Convertible Notes”) with detachable stock purchase warrants (the “Warrants”) to two separate investors (the “Investors”). Pursuant to separate securities purchase agreements, the Company issued and sold to the Investors 12% convertible promissory notes, each in the principal amount of $175,000, for an aggregate purchase price of $315,800 (reflecting a combined $34,200 in original issue discount and transaction fees). Pursuant to the purchase agreements, the Company also issued to each Investor a warrant exercisable to purchase 233,333 shares of the Company’s common stock, for an aggregate of 466,666 shares of common stock, subject to adjustment.
The notes had an original maturity date nine months from the date of issuance ( June 17, 2019). Under the original terms of the 2018 Convertible Notes, after six months from the date of issuance, the Investors could convert the notes, at any time, in whole or in part, into shares of the Company’s common stock, at a conversion price corresponding to a 40% discount to the average of the two lowest trading prices of the common stock during the 25 trading days prior to the conversion, subject to certain adjustments and price-protection provisions contained in the notes, including full-ratchet anti-dilution protection in the case of dilutive issuances of securities that did not meet the requirements of “exempt issuances” as defined in the notes.
Throughout the first three quarters of 2019, the Company entered into various amendments to the 2018 Convertible Notes. The amendments extended the date when the Company could prepay the notes and deferred the date upon which the Investors could initiate conversion of the notes into common shares of the Company pursuant to the notes’ terms until September 17, 2019. The Company paid the Investors amendment fees totaling $69,000 representing approximately 20% of the face value of the 2018 Convertible Notes and agreed to an increase in the principal balance of each note by $30,000 to $205,000. The maturity date of the Auctus note was also extended until July 31, 2019.
In December 2019, the Company further amended the 2018 Convertible Notes to provide for the settlement and extinguishment of all obligations under the 2018 Convertible Notes upon the (i) payment of an aggregate $220,000 to the Investors and (ii) issuance of an aggregate 350,000 shares of common stock to the Investors on or before February 10, 2020. The Company paid $220,000 to the Investors on December 10, 2019 and issued 350,000 shares of common stock on February 5, 2020 in full settlement of all obligations including accrued interest, and recognized a gain on debt extinguishment of approximately $246,000 in 2020 upon issuance of the common shares.
2019 Senior Secured Notes
In November and December 2019, the Company entered into note purchase agreements with certain investors providing for the issuance of $305,000 principal amount of 12% senior secured promissory notes (the “2019 Senior Secured Notes”) and warrants to acquire 457,500 shares of the Company’s common stock. The $220,000 of the proceeds were used primarily to partially repay the Company’s obligations under the 2018 Convertible Notes as discussed above.
On September 1, 2020, the Noteholders notified the Company of its default under the 2019 Senior Secured Notes and submitted a forbearance and recapitalization proposal to the Company. The 2019 Senior Secured Notes were settled in full in October 2020 (see 2020 Recapitalization below).
2020 Recapitalization
In October 2020 and in response to the declared default under the 2019 Senior Secured Notes, the Company entered into a Recapitalization Agreement (the “Recapitalization”) with its existing Deerfield Investors (“Deerfield”) and holders of its 2019 Senior Secured Notes (“Noteholders”) pursuant to which:
| ● | Deerfield exchanged its Series A Preferred Stock for 2.7 million shares of Common Stock – note that the Series A Preferred Stock did not originally contain a conversion option or redemption feature and was perpetual preferred stock. |
| ● | The Noteholders converted $305,000 of principal and $30,400 of accrued and unpaid interest of their Senior Secured Notes (the Company was in default at the time of the conversion) into 838,487 shares of Common Stock. |
| ● | The Noteholders agreed to purchase 487,500 shares of Common Stock for gross proceeds of $195,000 in cash. |
| ● | The Noteholders received warrants to purchase 3,977,961 shares of Common Stock at $0.40 per share. |
| ● | The Noteholders agreed to cancel the warrants originally issued with the 2019 Senior Secured Notes. |
The settlement of the Series A Preferred Stock was accounted for at fair value. The Company recognized a deemed dividend (contribution) resulting from the gain on the cancellation of its equity classified preferred stock, calculated as the difference between the fair value of the consideration transferred and the carrying value of the preferred stock. In addition, Lawrence S. Atinsky, the Deerfield Investors’ representative on the Company’s board, resigned and the number of Company directors was reduced to four. Outstanding options to purchase common stock held by Mr. Atinsky as of the Effective Date were forfeited.
The settlement of the 2019 Senior Secured Notes resulted in the conversion of the $305,000 principal balance of the Notes plus accrued interest of approximately $30,400 into an aggregate 838,487 shares of common stock (the “Conversion Shares”) of the Company at a conversion price of $0.40 per share, plus the purchase by the Noteholders, for cash, of 487,500 shares of common stock (the “Purchase Shares”) at $0.40 per share, or $195,000 in total. The settlement of the 2019 Senior Secured Notes was accounted for at fair value. The Company recognized a gain on extinguishment of the 2019 Senior Secured Notes of $89,776 calculated as the excess of the carrying amount of the debt (including the accrued interest) over the fair value of the reacquisition price (consisting of the fair value of the common stock and warrants issued net of the fair value of the warrants forfeited and cash received).
As part of the Recapitalization, the Company granted to each of three (3) individuals an aggregate of (i) 962,500 shares of common stock (the “Compensation Shares”) and (ii) fully vested warrants to purchase 2,887,500 shares of common stock of the Company (the “Compensation Warrants”) in consideration of past performance and service provided to the Company. The fair value of the Compensatory Shares and Compensatory Warrants was $333,628 which was recognized as stock-based compensation expense upon issuance.
2021 Warrant Modification
In December 2021, the Company entered into a Warrant Modification Agreement (the “Agreement”) with the employee holders and Investor holders of 6,865,461 Warrants whereby the Warrants were modified to decrease the exercise price from $0.40 to $0.20 per share provided the holders exercised the Warrant prior to January 31, 2022 (the “Modification”). All Warrants were exercised as of December 30, 2021. The Modification was accounted for at fair value; as such, additional stock-based compensation expense of $13,936 was recognized with respect to the employee warrants and a deemed dividend of $795,592 was recognized for the Investor warrants.
See Notes 5 and 6 for further discussion.
Note 3 – Liquidity and Summary of Significant Accounting Principles
Liquidity
Since our inception, we have financed our operations by raising debt, issuing equity and equity-linked instruments, and executing licensing arrangements, and to a lesser extent by generating royalties and product revenues. In mid-2019, we ceased ongoing operational activities as we worked to reach a favorable outcome to Medicare reimbursement coverage for the Aurix System. In April 2021 CMS issued an NCD establishing national reimbursement coverage for Aurix when used in chronic non-healing wounds where a diabetes clinical diagnosis exists for the patient. During 2021, 2020 and 2019, the Company raised net cash proceeds of approximately $1.9 million from the issuance of senior secured debt, common stock and from the exercise of stock purchase warrants. In conjunction with warrant exercises in December 2021, the Company initiated efforts to return to operational status as a commercial business. Subsequent to March 31, 2022, the Company raised proceeds of $3,550,000 from the sale of common stock to certain accredited investors in an equity private placement which closed on April 29, 2022.
We have incurred, and continue to incur, recurring losses and negative cash flows. As of March 31, 2022, we have an accumulated deficit of $24.0 million and cash and cash equivalents on hand of approximately $0.7 million. As of May 6, 2022, we have cash and cash equivalents on hand of approximately $3.8 million.
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet our obligations as they become due.
As a result of the closing of the private placement for proceeds of $3,500,000 on April 29, 2022, we have reevaluated our liquidity and financial condition and determined that sufficient capital exists to sustain operations one year from the date these condensed consolidated financial statements are available to be issued and therefore substantial doubt has been alleviated.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations and cash flows. The consolidated balance sheet at December 31, 2021, has been derived from audited financial statements of the Company as of that date. The interim unaudited consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules and regulations prescribed by the SEC. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim consolidated financial statements are read in conjunction with the audited financial statements and notes previously included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
The consolidated financial statements include the accounts of the Company and its wholly owned, controlled, and inactive subsidiary Aldagen, Inc. (“Aldagen”). All significant inter-company accounts and transactions are eliminated in consolidation
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to stock-based compensation, the fair value of common stock and equity-linked and derivative financial instruments, recoverability and depreciable lives of long-lived assets, deferred taxes and associated valuation allowance. Actual results could differ from those estimates.
Credit Concentration
We had no customer concentrations given our April 2019 decision to cease operational activities and the absence of any revenues in the three months ended March 31, 2022 and 2021 prior to the expected re-initiation of commercial sales activities by May 2022.
Historically, we used single suppliers for several components of the Aurix® product line. We outsource the manufacturing of various product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the products needed to satisfy customer demand. Additionally, while most of the components of Aurix are generally readily available on the open market, a reagent, bovine thrombin, is available exclusively through Pfizer, with whom we have an established vendor relationship.
Cash and Cash Equivalents
We consider all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. We maintain our cash and cash equivalents in the form of money market deposit accounts and qualifying money market funds and checking accounts with financial institutions that we believe are credit worthy.
Accounts Receivables, net
We expect to generate accounts receivables from the sale of our products. We will provide for an allowance against receivables for estimated losses that may result from a customer’s inability or unwillingness to pay. The allowance for doubtful accounts is estimated primarily based upon historical write-off percentages, known problem accounts, and current economic conditions. Accounts are written off against the allowance for doubtful accounts when we determine that amounts are not collectable. Recoveries of previously written-off accounts are recorded when collected. We had no trade accounts receivable as of March 31, 2022 and 2021 due to no commercial sales activities during those periods.
Other Receivables
The other receivable at March 31, 2022 represented the amount due from the landlord of our new warehouse/distribution facility as reimbursement for agreed tenant improvements per the lease agreement. The balance was collected subsequent to March 31, 2022.
Inventory, net
Our inventory is produced by third-party manufacturers and consists of raw materials and finished goods. Inventory cost is determined on a first-in, first-out basis and is stated at the lower of cost or net realizable value. We will maintain an inventory of kits, reagents, and other disposables having shelf-lives that generally range from 18 months to two years.
As of March 31, 2022, our inventory consisted entirely of raw materials acquired to facilitate the manufacturing of finished goods at our contract manufacturer and our warehouse/distribution facility.
We will provide for an allowance against inventory for estimated losses that may result in excess and obsolete inventory (i.e., from the expiration of products). Our allowance for expired inventory will be estimated based upon the inventory’s remaining shelf-life and our anticipated ability to sell such inventory, which is estimated using past experience and future forecasts, within its remaining shelf life. Expired products are segregated and used for demonstration purposes only; we will record the associated expense for this reserve to cost of sales in the consolidated statements of operations.
Property and Equipment
Property and equipment is stated at cost less accumulated depreciation and amortization. Assets are depreciated, using the straight-line method, over their estimated useful life ranging from one to six years. Leasehold improvements are amortized, using the straight-line method, over the lesser of the expected lease term or its estimated useful life ranging from one to three years. Amortization of leasehold improvements is included in depreciation expense and will begin in April 2022. Maintenance and repairs are charged to operations as incurred. Our medical equipment was fully depreciated as of March 31, 2022, while property and equipment acquired in March 2022 will begin being depreciated at the beginning of the month following its placed in-service date.
Leases
At the inception of a contract, the Company determines if the arrangement is, or contains, a lease. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term.
The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combines lease and non-lease elements of its operating leases.
Revenue Recognition
The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers; (ii) identification of distinct performance obligations in the contract; (iii) determination of contract transaction price; (iv) allocation of contract transaction price to the performance obligations; and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligations (upon transfer of control of promised goods or services to customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.
We provide for the sale of our products, including disposable processing sets and supplies to customers. Revenue from the sale of products is recognized upon shipment of products to the customers. We do not maintain a reserve for returned products, as in the past those returns have not been material and are not expected to be material in the future. Percentage-based fees on licensee sales of covered products are generally recorded as products are sold by licensees and are reflected as royalties in the consolidated statements of operations. Direct costs associated with product sales and royalty revenues are recorded at the time that revenue is recognized.
As more fully described above, we had no revenues in the three months ended March 31, 2022 or 2021.
Stock-Based Compensation
The fair value of employee stock options is measured at the date of grant. Expected volatilities are based on the equally weighted average historical volatility from five comparable public companies with an expected term consistent with ours. Expected years until exercise represents the period of time that options are expected to be outstanding using the "simplified method." The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The Company estimated that the dividend rate on its common stock will be zero. The assumptions for the three months ended March 31, 2022 and 2021 are summarized in the following table:
| | 2022 | | | 2021 | |
Risk free rate | | | 1.65 | % | | | 0.33 | % |
Weighted average expected years until exercise | | | 5-6 | | | | 5 | |
Expected stock volatility | | | 100 | % | | | 100 | % |
Dividend yield | | | - | | | | - | |
The Company elected to account for forfeitures of stock-based awards as they occur.
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. Tax rate changes are reflected in income during the period such changes are enacted. We measure our deferred tax assets and liabilities using the enacted tax rates that we believe will apply in the years in which the temporary differences are expected to be recovered or paid.
A deferred income tax asset or liability is recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credits and loss carryforwards. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. All of our tax years remain subject to examination by the tax authorities.
The Company’s policy for recording interest and penalties associated with audits is to record such items as a component of income before taxes. There were no such items in 2022 and 2021.
Basic and Diluted Earnings (Loss) per Share
In periods of net loss, basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. In periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive.
For periods of net income, diluted earnings per share is computed using the more dilutive of the “treasury method” or “two class method.” Dilutive earnings per share under the “treasury method” is calculated by dividing net income available to common stockholders by the weighted- average number of shares outstanding plus the dilutive impact of all potential dilutive common shares, consisting primarily of common shares underlying common stock options and stock purchase warrants using the treasury stock method, and convertible notes using the if-converted method. Because none of the Company’s equity-linked financial instruments contain non-forfeitable rights to dividends, the “two class” method results in the same diluted earnings per share as the “treasury method.”
All of the Company’s outstanding stock options and warrants were considered anti-dilutive for the three months ended March 31, 2022 and 2021. The following table sets forth the potential dilutive securities excluded from the calculation of diluted loss per share for the periods presented.
| | Three months ended March 31, 2022 | | | Three months ended March 31, 2021 | |
| | | | | | | | |
Shares underlying: | | | | | | | | |
Common stock options | | 2,536,667 | | | | 1,355,001 | |
Stock purchase warrants | | | 233,333 | | | | 13,278,794 | |
| | | 2,770,000 | | | | 14,633,795 | |
Recently Adopted Accounting Standards
In August 2020, the FASB issued new accounting guidance (ASU 2020-06) with respect to the accounting for convertible debt instruments and contracts in an entity’s own equity. The guidance simplifies the accounting for convertible instruments by reducing the various accounting models that can require the instrument to be separated into a debt component and equity component or derivative component. Additionally, the guidance eliminated certain settlement conditions previously required to be able to classify a derivative in equity. The new guidance is effective on a modified or full retrospective basis for fiscal years beginning after December 15, 2023, including interim periods with those fiscal years. The Company will evaluate the impact on the consolidated financial statements.
We have evaluated all other issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our results of operations, financial position, or cash flows.
Note 4 – Property and Equipment
Property and equipment, net consisted of the following:
| | March 31, 2022 | | | December 31, 2021 | |
| | | | | | | | |
Medical equipment | | $ | 387,665 | | | $ | 387,665 | |
Office equipment | | | 3,243 | | | | - | |
Warehouse/production equipment | | | 8,605 | | | | - | |
| | | 399,513 | | | | 387,665 | |
Less accumulated depreciation and amortization | | | (387,665 | ) | | | (387,665 | ) |
Property and equipment, net | | $ | 11,848 | | | $ | - | |
There was no depreciation expense of property and equipment for the three months ended March 31, 2022 and 2021. None of the Company's long-lived assets were deemed to be impaired during the three months ended March 31, 2022 and 2021.
Note 5 – Stock Purchase Warrants
The following schedule reflects outstanding stock purchase warrants activities as of March 31, 2022 and 2021:
Description | | March 31, 2022 | | | March 31, 2021 | |
| | | | | | | | |
May 2016 warrants | | | - | | | | 6,180,000 | |
2018 Convertible Notes warrants | | | 233,333 | | | | 233,333 | |
2020 Replacement warrants | | | - | | | | 3,977,961 | |
2020 Compensatory warrants | | | - | | | | 2,887,500 | |
Total | | | 233,333 | | | | 13,278,794 | |
As part of the May 2016 Plan of Reorganization, the Company issued warrants to purchase 6,180,000 shares of unregistered common stock to certain investors participating in the recapitalization of the Company. The warrants terminated on May 5, 2021 and were exercisable at exercise prices ranging from $0.50 per share to $0.75 per share.
The 2018 Convertible Notes warrants have a $0.15 strike price, approximately 1.5 years of remaining contractual term, and zero intrinsic value as of March 31, 2022 and are equity classified.
In connection with the Recapitalization and the conversion of the 2019 Senior Secured Notes, the Company issued to the noteholders stock purchase warrants to acquire 3,977,971 shares of the Company’s common stock. The warrants had an exercise price of $0.40, a term of five years, and were equity classified.
In connection with the Recapitalization and to compensate certain individuals for services performed in maintaining the Company’s viability, the Company issued stock purchase warrants to acquire 2,887,500 shares of the Company’s common stock. The warrants had an exercise price of $0.40, a term of five years, and were equity classified.
In connection with the Modification, the Company induced the exercise of existing stock purchase warrants to acquire 6,865,461 shares of the Company’s common stock by reducing the exercise price from $0.40 to $0.20 and requiring exercise by a certain date. All warrants were exercised by December 31, 2021 for gross proceeds of $1,373,092.
Note 6 – Equity and Stock-Based Compensation
Under the Second Amended and Restated Certificate of Incorporation, the Company has the authority to issue a total of 101,000,000 shares of capital stock, consisting of 100,000,000 shares of common stock and 1,000,000 shares of preferred stock, par value $0.0001 per share, which will have such rights, powers and preferences as the Board of Directors shall determine.
Stock-Based Compensation
In July 2016, the Board of Directors approved the Company’s 2016 Omnibus Incentive Plan (the “2016 Omnibus Plan”), and on August 4, 2016, the Board amended such plan to include an evergreen provision, intended to increase the maximum number of shares issuable under the Omnibus Plan on the first day of each fiscal year (starting on January 1, 2017) by an amount equal to six percent (6%) of the shares reserved as of the last day of the preceding fiscal year, provided that the aggregate number of all such increases may not exceed 1,000,000 shares. As of November 21, 2016, holders of a majority of our capital stock executed a written consent adopting and approving the 2016 Omnibus Plan, as amended and restated, which provides for the Company to grant equity and cash incentive awards to officers, directors and employees of, and consultants to, the Company and its subsidiaries. Further, on March 4, 2022, the Board approved an amendment to the 2016 Omnibus Plan to increase the shares available under to Plan to 4,250,000 and remove the annual evergreen provision. Effective as of April 21, 2022, holders of a majority of our common stock outstanding executed a written consent approving the March 2022 amendment to the 2016 Omnibus Plan which is expected to become effective on or around June 6, 2022.
A summary of stock option activity under the 2016 Omnibus Plan during the three months ended March 31, 2022 is presented below:
Stock Options – 2016 Omnibus Plan | | Shares | | | Weighted Average Exercise Price | | | Weighted Average Remaining Contractual Term | |
| | | | | | | | | | | | |
Outstanding at January 1, 2022 | | | 1,355,001 | | | $ | 0.52 | | | | 3.90 | |
Granted | | 1,181,666 | | | $ | 0.69 | | | | 10.00 | |
Exercised | | | - | | | $ | - | | | | - | |
Forfeited or expired | | | - | | | $ | - | | | | - | |
Outstanding at March 31, 2022 | | | 2,536,667 | | | $ | 0.60 | | | | 6.58 | |
Exercisable at March 31, 2022 | | | 2,103,334 | | | $ | 0.57 | | | 5.89 | |
There were 1,181,666 stock options granted under the 2016 Omnibus Plan during the three months ended March 31, 2022 of which (i) 206,666 options were granted to settle prior accrued compensation liabilities with senior management and Board of Directors, (ii) 450,000 of immediately vested options were granted to management, the Board of Directors, and a third-party service provider, and (iii) 525,000 incentive stock options vesting over 3 years were granted to employees. The fair value of the stock options granted in settlement of accrued liabilities was approximately $3,000. As the options issued were to related parties, the $103,333 of settled liabilities was credited to additional paid-in-capital. No stock options were exercised during the three months ended March 31, 2022. As of March 31, 2022, there was approximately $6,200 of unrecognized compensation cost related to the 525,000 non-vested stock options granted during the quarter.
For the three months ended March 31, 2022, the Company recorded stock-based compensation expense of $6,430. There was no stock based compensation expense for the three months ended March 31, 2021.
Note 7 – Commitments and Contingencies
Lease Agreements
In January 2022, the Company entered into a commercial operating lease agreement for its office space in Florida, expiring on December 31, 2024. The lease requires the Company to pay for its insurance, taxes, and its share of common operating expenses. The lease resulted in an increase in its right of use assets and lease liabilities of $89,312, using a discount rate of 10%.
Operating lease ROU assets are included in right of use assets in the Company's consolidated balance sheet as of March 31, 2022. Operating lease liabilities are classified as other current and non-current liabilities in the Company’s consolidated balance sheet.
The lease was cancelable by the landlord at any time prior to December 31, 2022 based on certain capital raising contingencies which the Company met in April 2022.
Total lease costs were approximately $7,000 for the three months ended March 31, 2022, consisting solely of operating lease costs.
Future undiscounted cash flows under this lease are:
2022 | | | 19,240 | |
2023 | | | 33,974 | |
2024 | | | 34,993 | |
Total | | | 88,207 | |
| | | | |
Discount factor | | | (12,151 | ) |
Lease liability | | | 76,056 | |
Current lease liability | | | (20,826 | ) |
Non-current lease liability | | $ | 55,230 | |
In February 2022 the Company entered into an additional commercial operating lease for its primary office and warehouse/distribution space in Texas. This lease expires in March 2027. The space remained under buildout and Landlord control as of March 31, 2022 with the Company acquiring control of the lease space effective April 1, 2022; as a result, the right of use asset and lease liability has not been recognized as of March 31, 2022. The future lease payments of $423,000 are not included in the above table.
Note 8 – Subsequent Events
Effective April 29, 2022, the Company closed on an equity private placement for the sale of 3,550,000 shares of common stock for proceeds of $3,550,000 to certain accredited investors under a Securities Purchase Agreement dated April 11, 2022 providing for the issuance of up to 4,000,000 shares of common stock.
On April 22, 2022, 775,000 incentive stock options were granted to non-executive employees at exercise prices of $0.75 or $1.00 with terms of ten years and subject to full vesting over three years.
The other receivable in the amount of $64,000 was received subsequent to March 31, 2022.
As of May 15, 2022, the Company received and accepted commitments for the sale of an additional 407,757 shares of common stock for proceeds of $407,757 to certain unaffiliated accredited investors under a Securities Purchase Agreement dated May 13, 2022. Closing of the transaction is expected to occur on May 18, 2022.