NOTES
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Note
1 - Description of the Company
On
July 11, 2019, Medovex Corp. (“MedoveX”) changed its named to H-CYTE, Inc. (“H-CYTE” or the “Company”)
by filing a Certificate of Amendment (the “Amendment”) to the Company’s Amended and Restated Certificate of
Incorporation (the “Certificate of Incorporation”) with the Secretary of the State of Nevada. The name change and
the Company’s new symbol, HCYT, became effective with FINRA on July 15, 2019.
On
October 18, 2018, H-CYTE (formerly named MedoveX) entered into an Asset Purchase Agreement (“APA”) with Regenerative
Medicine Solutions, LLC, RMS Shareholder, LLC (“Shareholder”), Lung Institute LLC (“LI”), RMS Lung Institute
Management LLC (“RMS LI Management”) and Cognitive Health Institute Tampa, LLC (“CHIT”), (collectively
“RMS”). On January 8, 2019, the APA was amended, and the Company acquired certain assets and assumed certain liabilities
of RMS as reported in the 8-K/A filed in March of 2019. Based on the terms of the APA and its amendment (collectively the “APA”),
the former RMS members had voting control of the combined company as of the closing of the RMS acquisition. For accounting purposes,
the acquisition transaction has been treated as a reverse acquisition whereby the Company is deemed to have been acquired by RMS
and the historical financial statements prior to the acquisition date of January 8, 2019 now reflect the historical financial
statements of RMS.
Prior
to the merger of H-CYTE and RMS on January 8, 2019 (the “Merger”), the consolidated results for H-CYTE include the
financial activities of Regenerative Medicine Solutions, LLC, LI, RMS Nashville, LLC (“Nashville”), RMS Pittsburgh,
LLC (“Pittsburgh”), RMS Scottsdale, LLC (“Scottsdale”), RMS Dallas, LLC (“Dallas”), State,
LLC (“State”), Cognitive Health Institute of Tampa (“CHIT”), RMS LI Management, and Shareholder,
H-CYTE included Lung Institute Dallas, PLLC (“LI Dallas”), Lung Institute Nashville, PLLC (“LI Nashville”),
Lung Institute Pittsburgh, PLLC (“LI Pittsburgh”), and Lung Institute Scottsdale, LLC (“LI Scottsdale”),
as Variable Interest Entities (“VIEs”).
As
of the merger, the consolidated results for H-CYTE include the following wholly-owned subsidiaries: H-CYTE Management, LLC (formerly
Blue Zone Health Management, LLC), Cognitive Health Institute, LLC, and Lung Institute Tampa, LLC (formerly Blue Zone Lung Tampa,
LLC). Additionally, H-CYTE has consolidated LI Dallas, LI Nashville, LI Pittsburgh, and LI Scottsdale, as VIEs.
The
Company’s RMS division is a healthcare medical biosciences company that develops and implements advanced innovative treatment
options in regenerative medicine to treat an array of debilitating medical conditions. In addition, the company is the operator
and manager of the various Lung Health Institute clinics. Committed to an individualized patient-centric approach, RMS consistently
provides oversight and management of the highest quality care while producing positive outcomes. RMS offices are located in Tampa,
Florida. The Lung Health Institute located in Tampa, Florida is a wholly owned subsidiary of RMS. RMS also provides oversight
and management to the Lung Health Institutes located in Nashville, TN, Scottsdale AZ, Pittsburgh, PA, and Dallas, TX.
On
June 21, 2019, H-CYTE entered into an agreement with Rion, LLC (“Rion”) to develop a disruptive cytotherapy technology
for chronic obstructive pulmonary disease (“COPD”), the fourth leading cause of death in the U.S. This agreement provides
for a 10-year exclusive and extendable supply agreement with Rion to enable H-CYTE to develop proprietary biologics. This will
be managed through a new Rion division of H-CYTE.
Rion
has established a novel technology to harness the healing power of the body. Rion’s novel exosome technology, based on science
developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in soft tissue, musculoskeletal, cardiovascular
and neurological organ systems.
With
this agreement, Rion will serve as the product supplier and co-develop a proprietary cellular platform with H-CYTE for the treatment
of COPD, and H-CYTE will control the commercial development and facilitate clinical trial investigation. After conducting joint
research and development of these biologics, H-CYTE intends to pursue submission of an investigational new drug (IND) application
for review by the U.S. Food and Drug Administration (“FDA”) for treatment of COPD.
The
Company is also in the business of designing and marketing proprietary medical devices for commercial use in the United States
and Europe. The Company received CE marking in June 2017 for the DenerveX System, and it is now commercially available throughout
the European Union and several other countries that accept CE marking. The Company’s first sale of the DenerveX System occurred
in July 2017. The Company is presently reevaluating its approaches to revenue generation including the continuing use of its distribution
channels, source of manufacturing, and evaluating joint venture opportunities. In July 2019, the Company signed a new engineering
feasibility proposal that would confirm a new sterilization process which would be a slightly less expensive option and expand
the shelf life of DenerveX from six months to a minimum of one year and potentially up to three years. The longer shelf life will
help the distributors reach more end-users as many hospital systems and medical practitioners will not purchase medical products
with less than a one-year shelf life. The Company still considers the United States to be a target market and it remains the Company’s
goal to seek FDA approval. The Company anticipates that it will do so once it is back in production and generating revenue through
sales in Europe and other approved countries.
Note
2 – Basis of presentation and Summary of Significant Accounting Policies
Based
on the terms of the APA, the former RMS members had voting control of the combined company as of the closing of the Merger. RMS
is deemed to be the acquiring company for accounting purposes and the transaction is accounted for as a reverse acquisition under
the acquisition method of accounting for business combinations in accordance with accounting principles generally accepted in
the United States (“U.S. GAAP”). The assets acquired and the liabilities assumed of RMS included as part of the purchase
transaction are recorded at historical cost. Accordingly, the assets and liabilities of H-CYTE are recorded as of the merger closing
date at their estimated fair values (see Note 3).
The
unaudited consolidated balance sheets, consolidated statements of operations, consolidated statements of stockholders’
equity (deficit), and the consolidated statements of cash flows do not reflect the historical financial information related
to H-CYTE prior to the Merger as they only reflect the historical financial information related to RMS. For the unaudited
consolidated statements of stockholders’ equity (deficit), the common stock, preferred stock, and additional paid in
capital reflect the accounting for the stock received by the RMS members as of the Merger as if it was received at the
beginning of the periods presented. The unaudited consolidated statements of stockholders’ equity (deficit) reflect the
activity from June 30, 2019 to September 30, 2019 and December 31, 2018 to September 30, 2019. For the comparable period from
December 31, 2017 to September 30, 2018, the only activity in the unaudited consolidated statement of stockholders’
equity (deficit) were the losses totaling approximately $1,035,251 and $2,295,173 for the three and nine months ended
September 30, 2018, respectively.
The
accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. GAAP and with the rules and
regulations of the Securities and Exchange Commission (“SEC”) that permit reduced disclosure for interim periods.
The unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements
and, in the opinion of management, reflect all adjustments necessary to present fairly the Company’s financial position
as of September 30, 2019 and December 31, 2018 and the results of operations for the three and nine months ended September 30,
2019 and 2018 and statements of cash flows for the nine months ended September 30, 2019 and 2018.
These
unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements, and notes
thereto for the fiscal year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K. The December
31, 2018 financial information included in the Company’s Annual Report on Form 10-K reflect the historical financial information
of the H-CYTE business and do not include the RMS financial information. With the reverse merger, historical financial information
for periods prior to the merger on January 8, 2019, presented in the comparative financial information included in the 2019 Form
10-Q, will only reflect the historical financial information related to RMS prior to the merger (see Note 3).
The
results for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for
the year ending December 31, 2019 or for any other interim period or for any future year.
Principles
of Consolidation
U.S.
GAAP requires that a related entity be consolidated with a company when certain conditions exist. An entity is considered to be
a VIE when it has equity investors who lack the characteristics of having a controlling financial interest, or its capital is
insufficient to permit it to finance its activities without additional subordinated financial support. Consolidation of a VIE
by the Parent would be required if it is determined that the Parent will absorb a majority of the VIE’s expected losses
or residual returns if they occur, retain the power to direct or control the VIE’s activities, or both.
The
accompanying unaudited consolidated financial statements include the accounts of the parent, its wholly-owned subsidiaries, and
its VIEs.
Accounts
Receivable
Accounts
receivable represent amounts due from customers for which revenue has been recognized. Generally, the Company does not require
collateral or any other security to support its receivables. Trade accounts receivable are stated net of an estimate made for
doubtful accounts, if any. Management evaluates the adequacy of the allowance for doubtful accounts regularly to determine if
any account balances will potentially be uncollectible. Customer account balances are considered past due or delinquent based
on the contractual agreement with each customer. Accounts are written off when, in management’s judgment, they are considered
uncollectible. At September 30, 2019 and December 31, 2018, management believes no allowance is necessary. For the three and nine
month periods ended September 30, 2019, the Company recorded bad debt expense of approximately $0 and $60,000, respectively.
Goodwill
And Intangibles
Goodwill
is recorded at fair value and not amortized but is reviewed for impairment at least annually or more frequently if impairment
indicators arise. Goodwill is evaluated for impairment by first performing a qualitative assessment to determine whether a quantitative
goodwill test is necessary. If it is determined, based on qualitative factors, that the fair value is “more likely than
not” less than the carrying amount or if significant changes related to the business have occurred that could materially
impact fair value, a quantitative goodwill impairment test would be required. The Company can elect to forego the qualitative
assessment and perform the quantitative test.
If
the carrying amount exceeds its fair value, “Step 1” is performed to determine if goodwill is impaired and to measure
the amount of impairment loss to recognize, if any. This step compares the implied fair value of goodwill with the carrying amount
of goodwill. If the carrying amount of goodwill exceeds the implied fair value, an impairment loss is recognized in an amount
equal to that excess.
The
implied fair value of goodwill is determined by assigning the fair value to all the assets and liabilities of that unit (including
any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination. The Company has elected
to perform the annual impairment assessment for goodwill in the fourth quarter.
Intangibles
acquired in a business combination are recorded at fair value using generally accepted valuation methods appropriate for the type
of intangible asset. Intangible assets with definite lives are amortized over the estimated useful lives and are reviewed for
impairment whenever events or changes in circumstances indicate that the carrying value may be greater than fair value. The Company’s
intangible assets are patents and related proprietary technology for the DenerveX System.
Leases
In
February 2016, the Financial Accounting Standard Board (“FASB”) established Topic 842, Leases, by issuing Accounting
Standards Update (ASU) No. 2016-02 (as amended), which requires lessees to recognize leases on the balance sheet and disclose
key information about leasing arrangements. The new standard establishes a right-of-use (“ROU”) model that requires
a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than twelve months.
Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition
in the statement of operations.
The
Company has not entered into significant lease agreements in which it is the lessor. For the lease agreements in which the Company
is lessee, under Topic 842, lessees are required to recognize a lease liability and right-of-use asset for all leases (with the
exception of short-term leases) at the lease commencement date. Effective January 1, 2019, the Company adopted this guidance,
applied the modified retrospective transition method and elected the transition option to use the effective date as the date of
initial application. The Company recognized the cumulative effect of the transition adjustment on the consolidated balance sheet
as of the effective date and did not provide any new lease disclosures for periods before the effective date. With respect to
the practical expedients, the Company elected the package of transitional-related practical expedients and the practical expedient
not to separate lease and non-lease components.
Other
Receivables
Other
receivables totaling approximately $34,000 at September 30, 2019 include receivables from the non-acquired Lung Institute, LLC
due to Lung Institute Tampa, LLC for approximately $19,000, and approximately $9,000 reimbursement receivable for reimbursement
of expenses from a joint study. The $19,000 receivable was a result of the Lung Institute, LLC being a transitory entity for Lung
Institute Tampa, LLC while the merchant services accounts are being transferred.
Revenue
Recognition
The
Company recognizes revenue in accordance with U.S. GAAP as outlined in the FASB ASC 606, Revenue From Contracts with Customers,
which requires that five steps be completed to determine when revenue can be recognized: (i) identify the contract with the customer;
(ii) identity the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction
price; and (v) recognize revenue when or as the entity satisfies a performance obligation. The Company records revenue under ASC
606 when control is transferred to the customer, which is consistent with past practice. The adoption of this standard did not
have a material impact on the consolidated financial statements.
Biomedical
Services
H-CYTE
wholly owns the Tampa, Florida Lung Health Institute (LHI) location and manages the other Lung Health Institute locations. The
Lung Health Institute uses a standard pricing model for the types of cellular therapy treatments that is offered to its patients.
The transaction price accounts for medical, surgical, facility, and office services rendered by LHI for consented procedures and
is recorded as revenue. The company recognizes revenue when the terms of a contract with a patient are satisfied.
The
Lung Health Institute locations offer two types of cellular therapy treatments to their patients. The first type of
treatment includes medical services rendered typically over a two-day period in which the patient receives cellular therapy.
For this treatment type, revenue is recognized in full at time of service. LHI also offers a four-day treatment in which
medical services are rendered typically over a two-day period and then again, approximately three months later, medical
services are rendered for an additional two days of treatment. Payment is collected in full for both service periods at the
time the first treatment is rendered. Revenue is recognized when services are performed based on the related professional,
facility, and diagnostic services for each session of treatment. The Company has deferred recognition of revenue amounting to
approximately $1,365,000 and $326,000 at September 30, 2019 and December 31, 2018, respectively.
Use
of Estimates
In
preparing the unaudited consolidated financial statements, U.S. GAAP requires disclosure regarding estimates and assumptions used
by management that affect the amounts reported in financial statements and accompanying notes. The Company’s significant
estimates include deferred revenue, the deferred income tax asset and the related valuation allowance, business acquisition accounting,
the fair value of its warrant issuances and share-based payment arrangements.
For
those estimates that are sensitive to the outcome of future events, actual results could differ from those estimates.
Stock-Based
Compensation
The
Company maintains a stock option incentive plan and accounts for stock-based compensation in accordance with ASC 718, Compensation
- Stock Compensation. The Company recognizes share-based compensation expense, net of an estimated forfeiture rate, over the
requisite service period of the award to employees and directors. As required by fair value provisions of share-based compensation,
employee and non-employee share-based compensation expense recognized is calculated over the requisite service period of the awards
and reduced for estimated forfeitures.
Income
Taxes
From
inception to September 30, 2019, the Company has incurred net losses and, therefore, has no current income tax liability. The
net deferred tax asset generated by these losses is fully reserved as of September 30, 2019 and December 31, 2018, respectively,
since it is currently likely that the benefit will not be realized in future periods.
As
a result of the acquisition, the Company is required to file federal income tax returns and state income tax returns in the states
of Arizona, Florida, Georgia, Minnesota, Pennsylvania, Tennessee, and Texas. There are no uncertain tax positions at September
30, 2019 or December 31, 2018. The Company has not undergone any tax examinations since inception.
Net
Loss Per Share
Basic
loss per share is computed on the basis of the weighted average number of shares outstanding for the reporting period. Diluted
loss per share is computed on the basis of the weighted average number of common shares plus dilutive potential common shares
outstanding using the treasury stock method. Any potentially dilutive securities are antidilutive due to the Company’s net
losses.
For
the periods presented, there is no difference between the basic and diluted net loss per share: 32,756,181 warrants and 517,509
common stock options outstanding were considered anti-dilutive and excluded for the three and nine month periods ended September
30, 2019. For the nine month period ended September 30, 2018, there were no dilutive securities as the accounting acquirer did
not historically have stock compensation programs.
Note
3 – Business Acquisition
On
January 8, 2019, MedoveX completed its business combination with RMS under which MedoveX purchased certain assets and assumed
certain liabilities of RMS, otherwise referred to as the Merger. Pursuant to the terms of the APA, MedoveX issued to the shareholders
of RMS 33,661 shares plus 6,111 additional Exchange Shares (based on closing the sale of $2 million of new securities) for a total
of 39,772 shares of Series C Preferred Stock where each share of Series C Preferred stock which automatically converted into 1,000
shares of common stock and represent approximately fifty-five percent (55%) of the outstanding voting shares of the Company.
Under
the terms of the APA, the Company issued additional “Exchange Shares” to the shareholders of RMS to maintain the 55%
ownership and not be diluted by the sale of convertible securities (“New Shares Sold”) until MedoveX raised an additional
$5.65 million via the issuance of new securities. On the date of closing the Company issued 6,111 additional Exchange Shares to
RMS Shareholders as a result of the issuance of additional securities, which are included in the 39,772 shares above. Subsequent
to the closing of the purchase transaction, an incremental 11,153 additional Exchange Shares were issued, for a total of 17,264
additional Exchange Shares. All additional Exchange Shares have been issued to the shareholders of RMS and these Series C Preferred
shares converted to 17,263,889 shares of common stock; no additional equity will be issued to RMS.
Because
RMS shareholders owned approximately 55% of the voting stock of MedoveX after the transaction, RMS was deemed to be the acquiring
company for accounting purposes (the “Acquirer”) and the transaction is accounted for as a reverse acquisition under
the acquisition method of accounting for business combinations in accordance with U.S. GAAP. The assets acquired and the liabilities
assumed of RMS included as part of the purchase transaction are recorded at historical cost. Accordingly, the assets and liabilities
of MedoveX (the “Acquiree”) are recorded as of the Merger closing date at their estimated fair values.
Under the terms of the APA, MedoveX purchased
certain assets and assumed certain liabilities of RMS. The assets of RMS reported on the MedoveX consolidated balance sheet as
of December 31, 2018 that were excluded in the Merger on January 8, 2019 was cash of approximately $70,000. The Merger
included the following: convertible debt to a related party of approximately $4,300,000, interest payable of approximately
$158,000, accounts payable of approximately $224,000 and other current liabilities of approximately $285,000. Additionally, there
were certain on-going litigation matters that were not assumed as part of the January 8, 2019 RMS reverse acquisition.
Purchase
Price Allocation
The
purchase price for the acquisition of the Acquiree has been allocated to the assets acquired and liabilities assumed based on
their estimated fair values. The purchase price allocation herein is preliminary. The final purchase price allocation will be
determined after completion of a thorough analysis to determine the fair value of all assets acquired and liabilities assumed
but in no event later than one year following completion of the acquisition. Accordingly, the final acquisition accounting adjustments
could differ materially from the allocation reflected as of September 30, 2019 presented herein. Any increase or decrease in the
fair value of the assets acquired and liabilities assumed, as compared to the information shown herein, could also materially
change the portion of purchase price allocated to goodwill and could materially impact the operating results of the Company following
the acquisition due to differences in purchase price allocation and depreciation and amortization related to some of these assets
and liabilities.
The
acquisition-date fair value of the consideration transferred is as follows:
Common shares issued and outstanding
|
|
|
24,717,271
|
|
Common shares reserved for issuance upon conversion of the outstanding Series B Preferred Stock
|
|
|
2,312,500
|
|
Total Common shares
|
|
|
27,029,771
|
|
Closing price per share of MedoveX Common stock on January 8, 2019
|
|
$
|
0.40
|
|
|
|
|
10,811,908
|
|
Fair value of outstanding warrants and options
|
|
|
2,220,000
|
|
Cash consideration to RMS
|
|
|
(350,000
|
)
|
Total consideration
|
|
$
|
12,681,908
|
|
Just
prior to the transaction, MedoveX had 24.5 million shares of common stock outstanding at a market capitalization of $9.8
million. The estimated fair value of the net assets of MedoveX was $8.4 million as of January 8, 2019. Measuring
the fair value of the net assets to be received by RMS was readily determinable based upon the underlying nature of the net
assets. The fair value of the MedoveX common stock is above the fair value of its net assets. The MedoveX net asset value is
primarily comprised of definite-lived intangibles as of the closing and the RMS interest in the merger is significantly
related to obtaining access to the public market. Therefore, the fair value of the MedoveX stock price and market
capitalization as of the closing date is considered to be the best indicator of the fair value and, therefore, the estimated
purchase price consideration. During the three months ended September 30, 2019 the Company revised its purchase price
allocation for the acquisition. As a result, the Company recorded a measurement period adjustment of $1,215,677 as an
increase to goodwill adjusting the amount recorded as of January 8, 2019. The adjustment resulted in a corresponding increase
to a derivative liability (see Note 12).
The
following table summarizes the fair values of the assets acquired and liabilities assumed at the date of acquisition on January
8, 2019:
Cash
|
|
$
|
(302,710
|
)
|
Accounts receivable
|
|
|
145,757
|
|
Inventory
|
|
|
131,455
|
|
Prepaid expenses
|
|
|
46,153
|
|
Property and equipment
|
|
|
30,393
|
|
Other
|
|
|
2,751
|
|
Intangibles
|
|
|
3,680,000
|
|
Goodwill
|
|
|
12,564,401
|
|
Total assets acquired
|
|
$
|
16,298,200
|
|
Accounts payable and other accrued liabilities
|
|
|
1,645,399
|
|
Derivative liability
|
|
|
1,215,677
|
|
Interest-bearing liabilities and other
|
|
|
755,216
|
|
Net assets acquired
|
|
$
|
12,681,908
|
|
Intangible
assets are recorded as definite-lived assets and amortized over the estimated period of economic benefit. Goodwill is calculated
as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired
and liabilities assumed. Goodwill is not expected to be deductible for income tax purposes. Goodwill is recorded as an indefinite-lived
asset and is not amortized but tested for impairment on an annual basis or when indications of impairment exist.
Total
interest bearing and other liabilities assumed are as follows:
Notes payable
|
|
$
|
99,017
|
|
Short-term convertible notes payable
|
|
|
598,119
|
|
Dividend payable
|
|
|
57,813
|
|
Deferred rent
|
|
|
267
|
|
Total interest-bearing and other liabilities
|
|
$
|
755,216
|
|
Notes
payable relate to promissory notes assumed by Acquiree in a 2015 acquisition, which was later divested in 2016, with the
assumed promissory notes being retained by Acquiree. The Company finalized an eighteen-month extension on the notes extending
the maturity date to March 1, 2021. Payments on both of the notes are due in aggregate monthly installments of approximately $5,800
and carry an interest rate of 5%. The promissory notes had outstanding balances of $95,000 as of September 30, 2019. The promissory
notes had outstanding balances of approximately $99,000 plus accrued interest of approximately $3,000 at January 8, 2019 (see
Note 11).
In
the third quarter of 2018, convertible notes were issued pursuant to a securities purchase agreement with select accredited
investors, whereby the Acquiree offered up to 1,000,000 units (the “Units”) at a purchase price of $50,000 per
Unit. Each Unit consisted of (i) a 12% senior secured convertible note, initially convertible into shares of the
Company’s common stock, par value $0.001 per share, at a conversion price equal to the lesser of $0.40 or ninety
percent (90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future
private placements of equity and/or debt securities completed by the Company following this offering of Units, and (ii) a
three-year warrant to purchase such number of shares of the Company’s common stock equal to one hundred percent (100%)
of the number of shares of common stock issuable upon conversion of the notes at $0.40. The warrants are exercisable at a
price equal to the lesser of $0.75 or ninety percent (90%) of the per share purchase price of any shares of common stock or
common stock equivalents issued in future private placements of the debt and/or equity securities completed by the Company
following the issuance of warrants. As a result of the price adjustment feature, the conversion price of the convertible
notes was adjusted to $0.36 per share.
In
the offering, the Acquiree sold an aggregate of 15 Units and issued to investors an aggregate of $750,000 in principal amount
of convertible notes and 1,875,000 warrants to purchase common stock, resulting in total gross proceeds of $750,000 to the Company.
If converted at $0.40 the convertible notes sold in the offering are convertible into an aggregate of 1,875,000 shares of common
stock. Due to the notes maturing during the third quarter of 2019, the warrants have fully accreted as of September 30, 2019.
The Acquiree recorded the proceeds from the notes and the accompanying warrants, which accrete over the period the notes are outstanding,
on a relative fair value basis of approximately $505,000 and $245,000, respectively. At acquisition date, the value of the notes
was approximately $598,000.
The
convertible notes had maturity dates between August and September 2019 and were renegotiated during the third quarter of 2019
(see Note 11).
The
following schedule represents the amounts of revenue and net loss attributable to the MedoveX acquisition which have been included
in the consolidated statements of operations for the periods subsequent to the acquisition date:
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30, 2019
|
|
|
September 30, 2019
|
|
Revenues
|
|
$
|
28,405
|
|
|
$
|
63,910
|
|
Net loss attributable to MedoveX
|
|
|
(7,203
|
)
|
|
|
(1,956,705
|
)
|
The
following unaudited pro forma financial information represents the consolidated financial information as if the acquisition had
been included in the consolidated results beginning on the first day of the fiscal year prior to its acquisition date. The pro
forma results have been calculated after adjusting the results of the acquired entity to remove any intercompany transactions
and transaction costs incurred and to reflect any additional depreciation and amortization that would have been charged assuming
the fair value adjustments to property and equipment and intangible assets had been applied on the first day of the fiscal year
prior to its acquisition date, together with the consequential tax effects. The pro forma results do not reflect any cost savings,
operating synergies or revenue enhancements that the combined entities may achieve as a result of the acquisition; the costs to
combine the companies’ operations; or the costs necessary to achieve these cost savings, operating synergies or revenue
enhancements. The pro forma results do not necessarily reflect the actual results of operations of the combined companies under
the current ownership and operation.
|
|
For the Three Months Ended September 30, 2018
|
|
|
|
RMS
|
|
|
MedoveX
|
|
|
Pro Forma
|
|
Revenues
|
|
$
|
1,536,990
|
|
|
$
|
206,159
|
|
|
$
|
1,743,149
|
|
Net loss
|
|
|
(1,035,251
|
)
|
|
|
(1,382,275
|
)
|
|
|
(2,417,526
|
)
|
Net loss attributable to common shareholders
|
|
|
(1,035,251
|
)
|
|
|
(1,512,326
|
)
|
|
|
(2,547,577
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share- basic and diluted
|
|
$
|
(0.03
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.04
|
)
|
|
|
For the Nine Months Ended September 30, 2018
|
|
|
|
RMS
|
|
|
MedoveX
|
|
|
Pro Forma
|
|
Revenues
|
|
$
|
6,880,794
|
|
|
$
|
598,773
|
|
|
$
|
7,479,567
|
|
Net loss
|
|
|
(2,295,173
|
)
|
|
|
(3,721,958
|
)
|
|
|
(6,017,131
|
)
|
Net loss attributable to common shareholders
|
|
|
(2,295,173
|
)
|
|
|
(4,119,068
|
)
|
|
|
(6,414,241
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share- basic and diluted
|
|
$
|
(0.07
|
)
|
|
$
|
(0.18
|
)
|
|
$
|
(0.11
|
)
|
Note
4 - Inventory
Inventory
consists only of finished goods and is valued at the lower of cost or net realizable value, using the first-in, first-out (FIFO)
method. Inventories were acquired in the Merger and therefore there were no inventories prior to January 8, 2019.
Inventory
consisted solely of the Pro-40 Generators totaling approximately $126,000 and $0 at September 30, 2019 and December 31, 2018,
respectively.
Note
5 – Right-of-use Asset And Lease Liability
Upon
adoption of ASU No. 2016-02 (as amended) (See Note 2), additional current liabilities of approximately $475,000 and long-term
liabilities of approximately $713,000 with corresponding ROU assets of approximately $1,167,000 were recognized, based on the
present value of the remaining minimum rental payments under the new leasing standards for existing operating leases.
The
unaudited consolidated balance sheet at September 30, 2019 reflects current lease liabilities of approximately $481,000 and long-term
liabilities of $396,000, with corresponding ROU assets of $859,000.
Operating
lease expense and cash flows from operating leases for the three and nine months ending September 30, 2019 totaled approximately
$140,000 and $389,000, respectively, and are included in the “Other general and administrative” section of the unaudited
consolidated statement of operations.
The
Company leases corporate office space in Tampa, FL and Atlanta, GA. The Company also leases medical clinic space in Tampa, FL,
Nashville, TN, Scottsdale, AZ, Pittsburgh, PA, and Dallas, TX. The leasing arrangements contain various renewal options that are
adjusted for increases in the consumer price index or agreed upon rates. Each location has its own expiration date ranging from
April 30, 2020 to August 31, 2023. The Company expects to renew each lease upon expiration in order to continue operations.
As
of September 30, 2019, the undiscounted minimum future maturities of lease liabilities are as follows:
Remainder of 2019
|
|
$
|
138,000
|
|
2020
|
|
|
482,000
|
|
2021
|
|
|
155,000
|
|
2022
|
|
|
103,000
|
|
2023
|
|
|
69,000
|
|
|
|
$
|
947,000
|
|
Note
6 - Property And Equipment
Property
and equipment, net, consists of the following:
|
|
Useful Life
|
|
September 30, 2019
|
|
|
December 31, 2018
|
|
Furniture and fixtures
|
|
5-7 years
|
|
$
|
147,870
|
|
|
$
|
149,285
|
|
Computers and software
|
|
3-7 years
|
|
|
361,986
|
|
|
|
278,234
|
|
Leasehold improvements
|
|
15 years
|
|
|
157,107
|
|
|
|
156,133
|
|
|
|
|
|
|
666,963
|
|
|
|
583,652
|
|
Less accumulated depreciation
|
|
|
|
|
(431,738
|
)
|
|
|
(316,736
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
235,225
|
|
|
$
|
266,916
|
|
Depreciation
expense was approximately $28,000 and $80,000, respectively, for the three and nine months ended September 30, 2019. Depreciation
expense was approximately $35,000 and $84,000, respectively, for the three and nine months ended September 30, 2018.
Note
7 - Intangible Assets
As
of September 30, 2019, intangible assets acquired as part of the Merger, net of accumulated amortization of $552,000, totaled
approximately $3,128,000. Amortization expense was $184,000 and $552,000 for the three and nine months ended September 30, 2019.
The
following is a schedule of expected future amortization of intangible assets as of September 30, 2019:
Remainder
of 2019
|
|
$
|
184,000
|
|
2020
|
|
|
736,000
|
|
2021
|
|
|
736,000
|
|
2022
|
|
|
736,000
|
|
2023
|
|
|
736,000
|
|
Total
|
|
$
|
3,128,000
|
|
Note
8 – Related Party Transactions
Consulting
Expense
The
Company entered into an oral consulting agreement with Mr. Raymond Monteleone, Board Member and Chairman of the Audit Committee,
in which Mr. Monteleone receives $10,000 per month for advisory services and $5,000 per quarter as Audit Committee Chair in addition
to regular quarterly board meeting fees. This arrangement has no specified termination date. For the three and nine months ended
September 30, 2019, the Company has expensed approximately $35,000 and $90,000 in compensation to Mr. Monteleone, respectively.
Board
Member Expenses
For
the three and nine months ended September 30, 2019, the Company paid $0 and $5,000 each for Board of Director fees to Michael
Yurkowsky and to Raymond Monteleone for a total of $0 and $10,000, respectively.
Debt
and Other Obligations
The
Company had various related party transactions in 2018. For the period of January 1, 2018 to March 13, 2018, the Company received
$528,175 from one of its shareholders (RMS members) and $228,175 from its CEO (RMS CEO) as part of a line of credit that was established
in 2017. On March 13, 2018, the entire $1,856,350 line of credit received from the Member and the CEO, including contributions
from 2017, was transferred to the BioCell Capital, LLC debt instrument, (“BioCell Capital Line of Credit”).
The
BioCell Capital Line of Credit also consisted of capital contributions from related parties totaling approximately $4,306,000,
inclusive of the aforementioned $1,856,300, to RMS in 2018. The BioCell Capital Line of Credit was converted to RMS members’
equity and was excluded from the APA on January 8, 2019.
The
Company also received a short-term advance from one of its shareholders (RMS members), who was also the CEO of H-CYTE, in the
amount of $180,000 in December 2018 for working capital needs. Approximately $66,000 of the advance was repaid in January 2019
and approximately $114,000 was converted to equity as part of the APA on January 8, 2019.
Horne
Management, LLC, controlled by Chief Executive Officer, William E. Horne, advanced funds for operations totaling
$900,000 on July 25, 2019. These loans accrue interest at 5.5% and are due and payable upon demand of the creditor.
In
addition, Horne Management, LLC loaned H-CYTE $350,000
on September 26, 2019, for working capital purposes. The terms of the loan as follows:
|
●
|
12%
interest rate with a maturity date of March 26, 2020.
|
|
●
|
If
the Company does not pay back the principal and interest by November 26, 2019, the Company shall issue to Lender a three-year
warrant to purchase 400,000 shares of the Company’s common stock with a purchase price of $0.75 per share.
|
|
●
|
If
the Company is unable to pay the loan as of March 26, 2020, the interest rate increases to 15%.
|
Note
9 - Equity Transactions
For
the consolidated statements of stockholders’ equity (deficit) as of December 31, 2018, the common stock, preferred stock
and additional paid in capital reflect the accounting for the stock received by the RMS members as of the Merger as if it was
received as of the beginning of the periods presented and the historical accumulated deficit of RMS. As of the closing of the
Merger, before the contingent additional exchange shares impact from the sale of new securities, the stock received by RMS was
33,661 shares of Series C Preferred Stock, which was later converted into approximately 33,661,000 shares of common stock, with
common stock par value of approximately $33,700 and additional paid-in capital of approximately $3,566,000. The historical accumulated
deficit of RMS as of the closing was approximately $9,296,000.
Common
Stock Issuance
On
January 8, 2019, the Company entered into a securities purchase agreement (the “SPA”) with four purchasers (the “Purchasers”)
pursuant to which the four Purchasers invested in the Company an aggregate amount of $2,000,000, with $1,800,000 in cash and $200,000
by cancellation of debt as explained below, in exchange for forty (40) units (the “Units”), each consisting of a convertible
note (the “Convertible Note”) with the principal amount of $50,000 and a warrant (the “Warrant”) to purchase
common stock (the “common stock”) of the Company at a purchase price of $.075 per share. Pursuant to this SPA, the
Company initially offered a minimum of $1,000,000 and a maximum of $6,000,000 Units, and subsequently increased the maximum amount
to $8,000,000 (the “Maximum Amount”) of Units at a price of $50,000 per Unit until the earlier of i) the closing of
the subscription of the Maximum Amount and ii) March 31, 2019 (the “Termination Date”), subject to the Company’s
earlier termination at its discretion. The SPA includes the customary representations and warranties from the Company and purchasers.
Steve Gorlin, the Company’s former Chairman of the Board, converted a $200,000 promissory note owed to him by the Company
in exchange for four (4) Units on the same terms as all other Purchasers. Mr. Gorlin subsequently converted the promissory note
underlying the Units into an aggregate of 500,000 shares of common stock, eliminating the Company’s debt obligation.
Each
Convertible Note had an interest rate of 12% per annum, a principal amount of $50,000 maturity date of January 8, 2020, and will
be convertible into shares of common stock at a price of $0.40 subject to adjustment as provided for in the Convertible Note.
Pursuant to the terms of the Convertible Note, each holder of the Convertible Note shall not own more than 4.99% of the number
of shares of common stock outstanding immediately after giving effect to the issuance of common stock issuable upon exercise of
such Convertible Note. If defaulted, the penalty interest rate of the Convertible Note shall rise to 18% per annum. In addition,
each Warrant is exercisable at a price of $0.75 per share (the “Exercise Price”), subject to adjustments stated therein.
The holder of each Warrant may purchase the number of shares of common stock equal to the number of shares of common stock issuable
upon conversion of each Convertible Note while the Warrant is exercisable. The Warrants have a term of three years and shall be
exercised in cash or on a cashless basis as described in the Warrant agreement. All Convertible Notes have been converted into
an aggregate of 18,000,000 shares of common stock.
As
reported on Form 8-K filings on January 25, 2019, February 8, 2019, March 15, 2019 and April 5, 2019, the Company entered into
other SPA’s with additional purchasers, which brought the aggregate amount of capital raised in all these offerings to $7,200,000,
as of that latest date.
As
a result of the sales of new securities of at least $5,650,000, the Company issued an additional 17,264 Series C Preferred Stock
which automatically converted to 17,263,889 shares of common stock.
All
the Convertible Notes from the SPA, as well as the shares of Series C Preferred Stock issued to RMS members, were automatically
converted into shares of common stock.
The
foregoing description of the SPA, Convertible Note, and Warrant is qualified in its entirety by reference to the respective agreements.
In
February 2019, 250,000 shares of common stock were issued pursuant to conversion of short-term debt and accrued interest.
In
March 2019, the Company issued an aggregate of 130,085 shares of common stock at $0.40 per share for consulting fees in an amount
equivalent to $52,034.
On
April 25, 2019, the Company issued 4,225,634 shares of common stock valued at $0.40 per share to Mr. William E. Horne,
the Company’s CEO, in a restricted stock award which was 100% vested when issued. The Company recognized approximately $1,690,000
of compensation expense in the quarter ended June 30, 2019 related to the restricted stock award. This restricted stock award
was issued pursuant to his employment agreement with the Company, which stated that this restricted stock award (as well
as the incentive stock options issued in the quarter ended March 31, 2019) would be fully vested if not issued within
fifteen days of the Merger. Neither award was issued within that time frame and both awards became fully vested when issued. The
aggregate number of shares of common stock from these two awards is 4,475,634 and was calculated based on 7% of the Company’s
issued and outstanding common stock as of the closing of the Merger.
During
the third quarter of 2019, the Company raised $100,000 by selling 200,000 shares of common stock at $0.50 per share. They also
issued the investors 100,000 warrants with an exercise price of $1.00 per share.
In
the third quarter of 2019, the Company issued 150,000 shares of common stock to a consultant in consideration of consulting services
rendered to the Company. At the time of issuance, the fair market value of the shares was $0.29, and, as a result, $43,500 was
expensed in the three and nine months ended September 30, 2019.
During
the nine months ended September 30, 2019, 636,480 shares were issued pursuant to conversions of some of our Series B Convertible
Preferred Stock (“Stock B Preferred”) and accrued dividends thereunder.
Series
B Preferred Stock Preferences
Voting
Rights
Holders
of our Series B Preferred Stock (“Series B Holders”) have the right to receive notice of any meeting of holders of
common stock or Series B Preferred Stock and to vote upon any matter submitted to a vote of the holders of common stock or Series
B Preferred Stock. Each Series B Holder shall vote on each matter submitted to them with the holders of common stock.
Liquidation
Upon
the liquidation, dissolution or winding up of the business of the Company, whether voluntary or involuntary, each Series B Holder
shall be entitled to receive, for each share thereof, out of assets of the Company legally available therefore, a preferential
amount in cash equal to the stated value plus all accrued and unpaid dividends. All preferential amounts to be paid to the Series
B Holders in connection with such liquidation, dissolution or winding up shall be paid before the payment or setting apart for
payment of any amount for, or the distribution of any assets of the Company’s to the holders of the Company’s common
stock. The Company accrues these dividends as they are earned each period.
On
January 8, 2019, the Company completed the issuance of Convertible Notes with a conversion price of $0.40. As a result, the exercise
price on all of the warrants issued with the Series B Preferred Stock was adjusted downward to 90% of that conversion price,
or $0.36.
The
Company recognized a beneficial conversion feature related to the Series B Preferred Stock of approximately $33,000, which was
credited to additional paid-in capital, and reduced the income available to common shareholders. Because the Series B Preferred
Stock can immediately be converted by the holder, the beneficial conversion feature was immediately accreted and recognized as
a deemed dividend to the preferred shareholders.
Series
B preferred Stock Conversions
During
the nine months ended September 30, 2019, 9,250 shares of Series B Preferred Stock, par value $0.001, and accrued dividends were
assumed with the Merger and an aggregate of 2,250 shares of Series B Preferred Stock, and accrued dividends, were subsequently
converted into an aggregate of 604,167 shares of the Company’s common stock.
Debt
Conversion
Convertible
Notes
The
$750,000 convertible notes payable assumed in the Merger had a fair value of approximately $598,000 on the acquisition date. Subsequently,
on February 6, 2019, $100,000 of the outstanding Convertible Notes was converted into an aggregate of 250,000 shares of common
stock, eliminating $100,000 of the Company’s debt obligation. The debt was converted into shares of common stock at $0.40
per share, in accordance with the SPA.
In
connection with the APA, on January 8, 2019, Steve Gorlin, the Company’s former Chairman of the Board, converted a $200,000
promissory note owed to him by the Company pursuant to the same terms of the SPA entered into by other investors to consummate
the acquisition on January 8, 2019. The promissory note was converted into an aggregate of 500,000 shares of common stock, eliminating
the Company’s debt obligation.
Stock-Based
Compensation Plan
2013
Stock Option Incentive Plan
The
Company utilizes the Black-Scholes valuation method to recognize stock-based compensation expense over the vesting period. The
expected life represents the period that the stock-based compensation awards are expected to be outstanding.
Including
the expense of approximately $1,690,000 related to the restricted stock award to the Company’s CEO, total stock-based compensation
expense for the three and nine months ended September 30, 2019 was approximately $1,473 and $1,786,500, respectively. The nine
months ended September 30, 2019 includes $1,690,000 of compensation expense related to the Company’s CEO restricted
stock award which was 100% vested when issued. This restricted stock award was issued pursuant to his employment agreement with
the Company, which stated that this option grant would be fully vested if not issued within fifteen days of the reverse merger
transaction. The restricted stock award was not issued within that time frame and was fully vested when issued.
Stock
Option Activity
For
the three and nine months ended September 30, 2019, the Company recognized approximately $1,500 and $94,000, respectively,
as compensation expense with respect to vested stock options. No compensation expense was recorded prior to the Merger. Since
these stock options were assumed on January 8, 2019 as part of the Merger, there were no historical costs related to this
prior to January 8, 2019. The expense for the nine months ended September 30, 2019 is primarily related to a fully-vested
option to purchase 250,000 shares of the Company’s common stock that was issued to the Company’s CEO pursuant to
his employment agreement, which stated that this option grant would be fully vested if it was not issued within fifteen days
of the Merger. The option was not granted within that time frame and was fully vested when issued.
As
of September 30, 2019, there were 9,501 shares of unvested stock options and unrecognized compensation expense totaled approximately
$2,400. The remaining expense will be recognized as an expense on a straight-line basis over a remaining weighted average service
period.
The
following is a summary of stock option activity for the nine months ending September 30, 2019:
|
|
Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Term
(Years)
|
|
Outstanding at December 31, 2018
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumed with the RMS merger transaction
|
|
|
557,282
|
|
|
$
|
2.78
|
|
|
|
6.06
|
|
Other activity since January 8, 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
250,000
|
|
|
$
|
0.40
|
|
|
|
9.27
|
|
Cancelled
|
|
|
(289,774
|
)
|
|
$
|
2.46
|
|
|
|
—
|
|
Outstanding at September 30, 2019
|
|
|
517,508
|
|
|
$
|
1.81
|
|
|
|
7.62
|
|
Exercisable at September 30, 2019
|
|
|
508,007
|
|
|
$
|
1.81
|
|
|
|
7.62
|
|
Note
10 – Commitments & Contingencies
Biotechnology
Agreement
On
June 21, 2019, the Company entered into a 10-year exclusive and extendable product supply agreement with Rion that will enhance
its existing cytotherapy product line, developing a disruptive technology for COPD, the fourth leading cause of death in the U.S.
Rion has established a unique exosome technology to harness the healing power of the body. Rion’s novel exosome technology,
based on science developed at Mayo Clinic, provides an off-the-shelf platform to enhance healing in soft tissue, musculoskeletal,
cardiovascular and neurological organ systems. With this agreement, Rion will serve as the product supplier and will co-develop
a proprietary cellular platform with H-CYTE for the treatment of COPD. H-CYTE will control the commercial development and facilitate
clinical trial investigation. After conducting joint research and development of these biologics, H-CYTE intends to pursue submission
of an investigational new drug (IND) application for review by the FDA for treatment of COPD.
Sublease
Agreement
The
Company entered into a sub-lease agreement for the lease in Alpharetta, Georgia. The period of the lease is from July 1, 2019
to December 31, 2020 and sublessee shall pay to sublessor a minimum rent, of $2,000 per month recognized by the Company as rental
income.
Consulting
Agreements
The
Company has reached a new agreement with Jesse Crowne, a former Director and Co-Chairman of the Board of the Company, to provide
business development consulting services for a fee of $5,000 per month. The Company incurred expense of approximately $10,000
and $50,000, for the three and nine months ended September 30, 2019, respectively, related to this consulting agreement. Since
this agreement was assumed on January 8, 2019 as part of the Merger, there were no historical costs related to this prior to January
8, 2019.
The
Company entered into a consulting agreement with LilyCon Investments, LLC effective February 1, 2019 for services related to evaluation
and negotiation of future acquisitions, joint ventures, and site evaluations/lease considerations. The duration of the consulting
agreement is for a period of twelve months in the amount of $12,500 per month with a $15,000 signing bonus which was paid in full
during the quarter ending March 31, 2019. The agreement also provides LilyCon Investments with $35,000 in stock (to be calculated
using an annual Variable Weighted Average Price from February 2019 through January 2020) to be granted on the one-year anniversary
of this agreement, if the agreement has not been terminated prior to that date. Either party may terminate this agreement with
or without cause upon 30 days written notice. For the three and nine months ended September 30, 2019, the Company expensed a total
of $37,500 and $115,000 in compensation to LilyCon Investments, respectively.
The
Company entered into an oral consulting arrangement with St. Louis Family Office, LLC, controlled by Jimmy St. Louis, former CEO
of RMS, in January 2019 in the amount of $10,000 per month plus benefits reimbursement for advisory services. The Company terminated
this agreement effective June 30, 2019. For the three and nine months ended September 30, 2019, the Company expensed $0 and $71,000
in consulting fees to St. Louis Family Office, respectively.
The
Company entered into a consulting agreement with Strategos Public Affairs, LLC (Strategos) on February 15, 2019 for a period of
twelve months, unless otherwise terminated by giving thirty days prior written notice. Strategos will provide information to key
policymakers in the legislature and executive branches of government on the benefits of the cellular therapies offered by the
Lung Health Institute, advocate for legislation that supports policies beneficial to patient access and oppose any legislation
that negatively impacts the Company’s ability to expand treatment opportunities, and position the Company and its related
entities as the expert for information and testimony. For the three and nine months ended September 30, 2019, the Company expensed
$22,500 and $48,500, respectively.
The
Company entered into a consulting agreement with Goldin Solutions, effective August 4, 2019, for media engagement and related
efforts, including both proactive public relations and crisis management services. The agreement has a minimum term of six months,
with a $33,000 monthly fee payable each month, with the exception of a first month discount of $12,000. For the three and nine
months ended September 30, 2019, the Company expensed $54,000.
Distribution
center and logistic services agreement
The
Company has a non-exclusive distribution center agreement with a logistics service provider in Berlin, Germany pursuant to which
they manage and coordinate the DenerveX System products which the Company exports to the EU through June 2020 The Company paid
a fixed monthly fee of €4,500 (approximately $5,000) for all accounting, customs declarations and office support, and a variable
monthly fee ranging from €1,900 to €6,900 (approximately $2,300 to $8,300), based off volume of shipments, for logistics,
warehousing and customer support services.
Total
expenses incurred for the distribution center and logistics agreement were approximately $10,080 and $40,080, respectively, for
the three and nine months ended September 30, 2019. Since this agreement was assumed on January 8, 2019 as part of the reverse
merger transaction, there were no historical costs related to this prior to January 8, 2019.
Patent
Assignment and Contribution Agreements
The
terms of a Contribution and Royalty Agreement dated January 31, 2013 with Dr. Scott Haufe, M.D was assumed in the Merger as of
January 8, 2019. This agreement provides for the Company to pay Dr. Haufe royalties equal to 1% of revenues earned from sales
of any and all products derived from the use of the DenerveX technology. Royalties are payable to Dr. Haufe within 30 days after
the close of each calendar quarter based on actual cash collected from sales of applicable products. The royalty period expires
on September 6, 2030.
The
Company incurred approximately $0 and $1,100 respectively, in royalty expense under the Contribution and Royalty agreement for
the three months and nine months ended September 30, 2019, all of which was included in accounts payable at September 30, 2019.
Since this agreement was assumed on January 8, 2019 as part of the Merger, there were no historical costs related to this prior
to January 8, 2019.
Litigation
From
time to time, the Company may be involved in routine legal proceedings, as well as demands, claims and threatened litigation that
arise in the normal course of our business. The ultimate amount of liability, if any, for any claims of any type (either alone
or in the aggregate) may materially and adversely affect the Company’s financial condition, results of operations and liquidity.
In addition, the ultimate outcome of any litigation is uncertain. Any outcome, whether favorable or unfavorable, may materially
and adversely affect the Company due to legal costs and expenses, diversion of management attention and other factors. The Company
expenses legal costs in the period incurred. The Company cannot assure that additional contingencies of a legal nature or contingencies
having legal aspects will not be asserted against the Company in the future, and these matters could relate to prior, current
or future transactions or events.
Guarantee
The
Company has guaranteed payments based upon the terms found in the management services agreements to two affiliated physicians
related to LI Nashville, LI Scottsdale, LI Pittsburgh, and LI Dallas. For the three and nine months ending September 30, 2019,
payments totaling approximately $42,000 and $105,000 respectively were made to these affiliates.
Note
11 – Short-term Debt
Notes
Payable
Short-term
financing payable relates to financing arrangements for Directors and Officers and general liability insurance premiums that were
financed at various points throughout 2018 and 2019 and two promissory notes assumed in the merger transaction.
These
financing arrangements require aggregate monthly payments of approximately $18,000, with interest rates ranging from 7% to 12.8%
and are to be paid in full by July 2020. The financing arrangements had balances of approximately $114,000 at September 30, 2019
and $31,000 at December 31, 2018. Interest expense related to these arrangements was approximately $2,000 and $4,300 for the three
and nine months ended September 30, 2019, respectively, and was $0 for the three and nine months ended September 30, 2018 respectively.
Two
promissory notes payable assumed in the Merger are due in aggregate monthly installments of approximately $5,700 and carry an
interest rate of 5%. Each note originally had a maturity date of August 1, 2019. During the third quarter, the Company finalized
an eighteen-month extension that extended the maturity date to March 1, 2021. The promissory notes have an aggregate outstanding
balance of approximately $95,000 at September 30, 2019. The Company incurred interest expense related to the promissory notes
for the three and nine months ended September 30, 2019 in the amount of approximately $400 and $2,500, respectively; no interest
expense was incurred during 2018 as these notes were assumed on January 8, 2019.
The
Company’s interest expense of approximately $50,000 and $121,000 for the three and nine months ended September 30, 2018,
respectively, was related to convertible debt not assumed in the Merger as of January 8, 2019.
Convertible
Notes
The
Convertible Notes payable represents a securities purchase agreement with select accredited investors, which was assumed in the
Merger. The debt assumed by the Company consisted of $750,000 of units (the “Units”) with a purchase price of $50,000
per Unit. Each Unit consists of (i) a 12% senior secured convertible note, initially convertible into shares of the Company’s
common stock, par value $0.001 per share, at a conversion price equal to the lesser of $0.40 or ninety percent (90%) of the per
share purchase price of any shares of common stock or common stock equivalents issued in future private placements of equity and/or
debt securities completed by the Company following this offering, and (ii) a three-year warrant to purchase such number of shares
of the Company’s common stock equal to one hundred percent (100%) of the number of shares of common stock issuable upon
conversion of the notes at $0.40. The Warrants were initially exercisable at a price equal to the lesser of $0.75 or ninety percent
(90%) of the per share purchase price of any shares of common stock or common stock equivalents issued in future private placements
of the debt and/or equity securities completed by the Company following the issuance of warrants. The Convertible Notes are secured
by all of the assets of the Company.
The
Company recorded the proceeds from the notes and the accompanying warrants, which accrete over the period the notes are outstanding,
on a relative fair value basis of $505,424 and $244,576, respectively. Interest expense related to the discount on these convertible
notes for the three and nine month period ending September 30, 2019 was approximately $24,000 and $151,900, respectively. The
Company recognized approximately $19,300 and $60,500, respectively, in unpaid accrued interest expense related to the notes for
the three and nine months ended September 30, 2019.
The
Convertible Notes sold in the offering were initially convertible into an aggregate of 1,875,000 shares of common stock. The down
round feature was triggered on January 8, 2019, and the conversion price of the Convertible Notes was adjusted to $0.36. The Company
recognized the down round as a deemed dividend of approximately $288,000 which reduced the income available to common stockholders.
On
February 6, 2019, $100,000 of the Company’s $750,000 outstanding Convertible Notes plus accrued interest was converted into
an aggregate of 251,667 shares of common stock, eliminating $100,000 of the Company’s debt obligation. The debt was converted
into shares at $0.36 per share, which was the conversion price per the SPA subsequent to the trigger of the down round feature.
The convertible notes had maturity dates between August and September 2019.
The
Company negotiated a short-term extension with two of the three noteholders through the expected closing of the Series D
Security Purchase Agreement (the “Short-term Extension Notes”). As of September 30, 2019, approximately $479,000,
which includes the principal balance of $350,000, fees and penalties of approximately $80,000 and accrued interest of
approximately $49,000 is due to the two Short-term Extension Notes noteholders.
The
Company also reached an extension with the third noteholder which extended the maturity date of the loan for one year, until September
30, 2020. This note has a principal balance of $300,000 plus penalties of approximately $85,000 and accrued interest of approximately
$40,000 for a total amount due of approximately $425,000 (the “New Principal”) as of September 30, 2019. This amount
has been rolled into a new note effective September 30, 2019 (the “One Year Extended Note”). Additionally, approximately
424,000 warrants were issued in connection with the One Year Extended Note. The fair market value of the warrants on September
18, 2019, the day the warrants were issued, was approximately $106,000, which the Company recognized as an expense in the three
months ended September 30, 2019.
In
the aggregate, the new principal balance on these convertible notes as of September 30, 2019 is approximately $775,000 which is
comprised of the original principal balance of $350,000 on the Short-term Extension Notes plus $425,000 for the New Principal
on the One Year Extended Note.
Note
12 – Derivative Liability Warrants
In connection with the securities purchase
agreements executed in May 2018 the Company issued 108,250 shares of the Company’s Series B Convertible Preferred Stock
(the “Series B Shares”) and warrants to purchase 2,312,500 shares of the Company’s common stock. The warrants
had a three-year term at an exercise price of $0.75. The warrants contain two features such that in the event of a downward
price adjustment the Company is required to reduce the strike price of the existing warrants (first feature or “down round”)
and issue additional warrants to the award holders such that the aggregate exercise price after taking into account the adjustment,
will equal the aggregate exercise price prior to such adjustment (second feature or “additional issuance”).
On January 8, 2019 the Company issued equity
securities which triggered the down round and additional issuance warrant features. As a result, the exercise price of the warrants
was lowered from $0.75 to $0.40 and 2,023,438 additional warrants were issued. The inclusion of the additional issuance feature
caused the warrants to be accounted for as liabilities in accordance with ASC Topic 815.
The
fair market value of the warrants, approximately $1,200,000, has been recorded as a derivative liability in the
purchase price allocation as a measurement period adjustment during the period ended September 30, 2019 (see Note 3). The
derivative liability has been remeasured to fair value at the end of each reporting period and the cumulative change in fair
value, approximately $884,000, has been recorded as a component of other income (expense) in the Company’s consolidated
statement of operations for the three and nine month period ended September 30, 2019. The fair value of the
derivative liability included on the consolidated balance sheet was approximately $332,000 as of September 30,
2019.
Note
13 - Common Stock Warrants
Fair
value measurement valuation techniques, to the extent possible, should maximize the use of observable inputs and minimize the
use of unobservable inputs. The Company’s fair value measurements of all warrants are designated as Level 1 since all of
the significant inputs are observable and quoted prices used for volatility were available in an active market.
A
summary of the Company’s warrant issuance activity and related information for the nine months ended September 30, 2019
is as follows:
|
|
Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
Assumed as of the January 8, 2019 merger
|
|
|
12,108,743
|
|
|
$
|
1.38
|
|
|
|
1.78
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued
|
|
|
20,647,437
|
|
|
$
|
0.72
|
|
|
|
2.36
|
|
Outstanding and exercisable at September 30, 2019
|
|
|
32,756,180
|
|
|
$
|
.96
|
(1)(2)
|
|
|
2.15
|
|
The
fair value of all warrants issued are determined by using the Black-Scholes valuation technique and were assigned based on the
relative fair value of both the common stock and the warrants issued. The inputs used in the Black-Scholes valuation technique
to value each of the warrants issued at September 30, 2019 as of their respective issue dates are as follows:
Event
Description
|
|
Date
|
|
H-CYTE
Stock Price
|
|
|
Exercise Price of Warrant
|
|
|
Grant Date Fair Value
|
|
|
Life
of Warrant
|
|
Risk Free Rate of Return (%)
|
|
|
Annualized Volatility Rate (%)
|
|
Private placement
|
|
1/8/2019
|
|
$
|
0.40
|
|
|
$
|
0.75
|
|
|
$
|
0.24
|
|
|
3 years
|
|
|
2.57
|
|
|
|
115.08
|
|
Antidilution provision(3)
|
|
1/8/2019
|
|
$
|
0.40
|
|
|
$
|
0.40
|
|
|
$
|
0.28
|
|
|
3 years
|
|
|
2.57
|
|
|
|
115.08
|
|
Private placement
|
|
1/18/2019
|
|
$
|
0.40
|
|
|
$
|
0.75
|
|
|
$
|
0.23
|
|
|
3 years
|
|
|
2.60
|
|
|
|
114.07
|
|
Private placement
|
|
1/25/2019
|
|
$
|
0.59
|
|
|
$
|
0.75
|
|
|
$
|
0.38
|
|
|
3 years
|
|
|
2.43
|
|
|
|
113.72
|
|
Private placement
|
|
1/31/2019
|
|
$
|
0.54
|
|
|
$
|
0.75
|
|
|
$
|
0.34
|
|
|
3 years
|
|
|
2.43
|
|
|
|
113.47
|
|
Private placement
|
|
2/7/2019
|
|
$
|
0.57
|
|
|
$
|
0.75
|
|
|
$
|
0.36
|
|
|
3 years
|
|
|
2.46
|
|
|
|
113.23
|
|
Private placement
|
|
2/22/2019
|
|
$
|
0.49
|
|
|
$
|
0.75
|
|
|
$
|
0.30
|
|
|
3 years
|
|
|
2.46
|
|
|
|
113.34
|
|
Private placement
|
|
3/1/2019
|
|
$
|
0.52
|
|
|
$
|
0.75
|
|
|
$
|
0.33
|
|
|
3 years
|
|
|
2.54
|
|
|
|
113.42
|
|
Private placement
|
|
3/8/2019
|
|
$
|
0.59
|
|
|
$
|
0.75
|
|
|
$
|
0.38
|
|
|
3 years
|
|
|
2.43
|
|
|
|
113.53
|
|
Private placement
|
|
3/11/2019
|
|
$
|
0.61
|
|
|
$
|
0.75
|
|
|
$
|
0.40
|
|
|
3 years
|
|
|
2.45
|
|
|
|
113.62
|
|
Private placement
|
|
3/26/2019
|
|
$
|
0.51
|
|
|
$
|
0.75
|
|
|
$
|
0.32
|
|
|
3 years
|
|
|
2.18
|
|
|
|
113.12
|
|
Private placement
|
|
3/28/2019
|
|
$
|
0.51
|
|
|
$
|
0.75
|
|
|
$
|
0.31
|
|
|
3 years
|
|
|
2.18
|
|
|
|
112.79
|
|
Private placement
|
|
3/29/2019
|
|
$
|
0.51
|
|
|
$
|
0.75
|
|
|
$
|
0.31
|
|
|
3 years
|
|
|
2.21
|
|
|
|
112.79
|
|
Private placement
|
|
4/4/2019
|
|
$
|
0.48
|
|
|
$
|
0.75
|
|
|
$
|
0.29
|
|
|
3 years
|
|
|
2.29
|
|
|
|
112.77
|
|
Private placement
|
|
7/15/2019
|
|
$
|
0.53
|
|
|
$
|
1.00
|
|
|
$
|
0.31
|
|
|
3 years
|
|
|
1.80
|
|
|
|
115.50
|
|
Convertible debt extension
|
|
9/18/2019
|
|
$
|
0.40
|
|
|
$
|
0.75
|
|
|
$
|
0.25
|
|
|
3 years
|
|
|
1.72
|
|
|
|
122.04
|
|
(1)Warrants
issued with the May 2018 private placement and debt conversion had an initial exercise price of $0.75 and contain a contingent
feature which would adjust the exercise price of the warrant in the event the Company issues any shares of common stock or common
stock equivalents in a private placement of equity or debt securities at a price less than $0.75 per share. On August 8, 2018,
the Company completed the issuance of convertible debt at an initial conversion price of $0.40. Accordingly, the exercise price
on these warrants was adjusted downward to $0.40.
(2)Warrants
issued with the August 8, 2018 and September 28, 2018 convertible notes had an initial exercise price of $0.75 and contain a contingent
feature which would adjust the exercise price of the warrants in the event the Company issued any shares of common stock or common
stock equivalents in a private placement of equity or debt securities to 90% of the issuance price if it is less than $0.75.
(3)
The Company had warrants that triggered the required issuance of an additional 2,023,438 warrants as a result of the Company’s
capital raise that gave those new investors a $0.40 per share investment price which required the old warrant holders to receive
additional warrants since their price was $0.75 per share.
The
methods described above may produce a fair value calculation that may not be indicative of net realizable value or reflective
of future fair values. Furthermore, while the Company believes its valuation methods are appropriate and consistent with other
market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments
could result in a different fair value measurement at the reporting date.
Note
14 - Liquidity, Going Concern and Management’s Plans
The
Company incurred net losses of approximately $11,616,000 and $2,295,000 for the nine months ended September 30, 2019 and
2018, respectively.
The
Biomedical products and services division will incur losses until sufficient revenue volume and geographical coverage is attained
utilizing the infusion of capital resources to expand marketing and sales initiatives.
In
April 2019, the Company determined that their contract manufacturer was not able to meet the quality and quantity requirements
for producing the DenerveX product. As a result, the manufacture of the DenerveX product has been temporarily suspended while
the Company sources alternative manufacturing options. Additionally, in the Company’s review and evaluation of its current
distribution channels, the Company has determined that many of these channels were not cost effective. As a result of the above
evaluations, certain European distributor agreements were terminated, and all other representatives have been notified that the
Company is temporarily suspending the manufacture and sale of the DenerveX product while the Company sources alternative manufacturing
and distributor options as well as considers other product monetizing strategies, including strategic partnerships. The H-CYTE
operations will continue to incur losses until the plan for the DenerveX System monetization is determined and executed.
The
Company’s independent registered public accounting firm has included an explanatory paragraph with respect to our ability
to continue as a going concern in its report on the Company’s consolidated financial statements for the year ended December
31, 2018. The presence of the going concern explanatory paragraph suggests that the Company may not have sufficient liquidity
or minimum cash levels to operate the business. Since inception, the Company has incurred losses and anticipates that the Company
will continue to incur losses until its products can generate enough revenue to offset its operating expenses. The Company,
through September 2019, raised $7,100,000 (excluding $200,000 of debt conversions) year to date.
The
Company pursued raising additional funds from the sale of equity securities. On June 7, 2019 the Board of Directors approved a
new private placements securities offering up to $8,500,000 of common stock at a price of $0.50 per share, and a three-year warrant
to purchase such number of shares of common stock equal to fifty percent (50%) of the number of shares of common stock issuable
as part of this offering (the “Warrants”), at an exercise price of $1.00 per share. The Company raised $100,000 from
these new private placement securities since June 30, 2019. The aforementioned security offering has been terminated.
On
October 26, 2019, the Board of Directors approved a new private placement securities offering up to $9,750,000 of Series D Preferred
Stock (“Series D Preferred”). The terms of this offering are up to $9,750,000 to be raised at $.41 per share with
100% warrant coverage at $.75 per share for a term of ten years. The Series D Preferred will carry an annual 8% cumulative dividend
payable upon a liquidation or redemption. For any other dividends, the Series D Preferred will participate with common stock on
an as-converted basis.
On
July 25 and July 26, 2019, the Company issued two promissory notes (the “Notes”) in the aggregate principal amount
of $900,000 to Horne Management, LLC, and controlled by Mr. William E. Horne, the Chief Executive Officer of the Company. The
Notes bear an interest rate of 5.5% per annum and are due on demand. The Company has received the funds represented by the Notes.
On September 26, 2019, the Company issued a promissory note to Horne Management, LLC, for $350,000. The Terms of the Note are:
|
●
|
12%
interest rate with a maturity date of March 26, 2020.
|
|
●
|
If
the Company is unable to pay the loan as of March 26, 2020, the interest rate increases
to 15%.
|
|
●
|
If
the Company does not pay back the principal and interest by November 26, 2019, the Company
shall issue to Lender a three-year warrant to purchase 400,000 shares of the Company’s
common stock at a purchase price of $0.75 per share.
|
The
Company has certain convertible promissory notes in the aggregate principal amount of approximately $650,000 that originally matured
in August and September 2019. The convertible notes are secured by all of the assets of the Company. The Company negotiated an
extension with two of the three noteholders through the expected closing of the Series D Preferred .There were certain fees and
penalties that were negotiated along with these extensions in the aggregate amount of approximately $80,000. The Company also
reached an extension with the third noteholder which extended the maturity date of the loan for one year, until September 30,
2020, plus interest and penalties. The penalties associated with the extension of this loan were approximately $125,000 as outlined
in the terms of the original agreement. The total liability on these notes including principal, accrued interest, and penalties
is approximately $904,000.
There
can be no assurances that the Company will be able to obtain additional financing on commercially reasonable terms, if at all.
If the Company is required to curtail operations, there would be substantial doubt about the Company’s ability to continue
as a going concern. Cash as of September 30, 2019 was approximately $368,000. The present level of cash and the fourth quarter
raise to date may not be sufficient to satisfy the Company’s current operating requirements, as such, the additional raising
of funds is required.
The
unaudited consolidated financial statements do not include any adjustments to the carrying value of amounts of its assets or liabilities
that might be necessary should the Company be unable to continue as a going concern.
Note
15 - Subsequent Events
Horne
Management, LLC loaned H-CYTE $150,000 on October 28, 2019, for working capital purposes. The terms of the loan are as follows:
|
●
|
12%
interest rate with a maturity date of April 28, 2020.
|
|
●
|
If
the Company does not pay back the principal and interest by December 28, 2019, the Company
shall issue to Lender a three-year warrant to purchase 171,429 shares of the Company’s
common stock at a purchase price of $0.75 per share.
|
|
●
|
If
the Company is unable to pay the loan as of April 28, 2020, the interest rate increases
to 15%.
|
On November 13, 2019 the Company issued
a promissory note (the “Note”) with a principal amount of $235,000 to Horne Management, LLC. The Note bears an interest rate of 12% per annum and is due on demand. The terms of
the note are:
|
●
|
12% interest rate
with a maturity date of May 13, 2020.
|
|
●
|
If the Company
does not pay back the principal and interest by January 13, 2020, the Company shall issue to Lender a three-year warrant to
purchase 268,571 shares of the Company’s common stock at a purchase price of $0.75 per share.
|
|
●
|
If the Company
is unable to pay the loan as of April 28, 2020, the interest rate increases to 15%.
|